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EU Law

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Глосарій термінів acquis ЄС"> Глосарій термінів acquis ЄС
provider of electronic communications to the public means an undertaking providing public communications networks or publicly available electronic communications services
internet access service means a publicly available electronic communications service that provides access to the internet, and thereby connectivity to virtually all end points of the internet, irrespective of the network technology and terminal equipment used
Paris MOU means the Memorandum of Understanding on Port State Control, signed in Paris on 26 January 1982, in its up-to-date version
Paris MOU region means the geographical area in which the signatories to the Paris MOU conduct inspections in the context of the Paris MOU
ship/port interface means the interactions that occur when a ship is directly and immediately affected by actions involving the movement of persons or goods or the provision of port services to or from the ship
ship at anchorage means a ship in a port or another area within the jurisdiction of a port, but not at berth, carrying out a ship/port interface
inspector means a public-sector employee or other person, duly authorised by the competent authority of a Member State to carry out port-State control inspections, and responsible to that competent authority
night time means any period of not less than seven hours, as defined by national law, and which must include, in any case, the period between midnight and 5.00
initial inspection means a visit on board a ship by an inspector, in order to check compliance with the relevant Conventions and Regulations and including at least the checks required by Article 13(1)
more detailed inspection means an inspection where the ship, its equipment and crew as a whole or, as appropriate, parts thereof are subjected, in the circumstances specified in Article 13(3), to an in-depth examination covering the ship’s construction, equipment, manning, living and working conditions and compliance with on-board operational procedures
expanded inspection means an inspection, which covers at least the items listed in Annex VII. An expanded inspection may include a more detailed inspection whenever there are clear grounds in accordance with Article 13(3)
Conventions means the following Conventions, with the Protocols and amendments thereto, and related codes of mandatory status, in their up-to-date version: (a) the International Convention on Load Lines, 1966 (LL 66); (b) the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74); (c) the International Convention for the Prevention of Pollution from Ships, 1973, and the 1978 Protocol relating thereto (Marpol 73/78); (d) the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (STCW 78/95); (e) the Convention on the International Regulations for Preventing Collisions at Sea, 1972 (Colreg 72); (f) the International Convention on Tonnage Measurement of Ships, 1969 (ITC 69); (h) the International Convention on Civil Liability for Oil Pollution Damage, 1992 (CLC 92); (i) the Maritime Labour Convention, 2006 (MLC 2006); (j) the International Convention on the Control of Harmful Anti-fouling Systems on Ships, 2001 (AFS 2001); (k) the International Convention on Civil Liability for Bunker Oil Pollution Damage, 2001 (Bunkers Convention, 2001)
framework and procedures for the Voluntary IMO Member State Audit Scheme means IMO Assembly Resolution A.974(24)
ship means any seagoing vessel to which one or more of the Conventions apply, flying a flag other than that of the port State
competent authority means a maritime authority responsible for port State control in accordance with this Directive
complaint means any information or report submitted by any person or organisation with a legitimate interest in the safety of the ship, including an interest in safety or health hazards to its crew, on-board living and working conditions and the prevention of pollution
detention means the formal prohibition for a ship to proceed to sea due to established deficiencies which, individually or together, make the ship unseaworthy
refusal of access order means a Decision issued to the master of a ship, to the company responsible for the ship and to the flag State notifying them that the ship will be refused access to all ports and anchorages of the Community
stoppage of an operation means a formal prohibition for a ship to continue an operation due to established deficiencies which, individually or together, would render the continued operation hazardous.
company means the owner of the ship or any other organisation or person such as the manager, or the bareboat charterer, who has assumed the responsibility for operation of the ship from the owner of the ship and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed by the International Safety Management (ISM) Code
Recognised Organisation means a classification company or other private body, carrying out statutory tasks on behalf of a flag State administration
statutory certificate means a certificate issued by or on behalf of a flag State in accordance with Conventions
classification certificate means a document confirming compliance with SOLAS 74, Chapter II-1, Part A-1, Regulation 3-1
inspection database means the information system contributing to the implementation of the port State control system within the Community and concerning the data related to inspections carried out in the Community and the Paris MOU region
maritime labour certificate means the certificate referred to in Regulation 5.1.3 of MLC 2006
declaration of maritime labour compliance means the declaration referred to in Regulation 5.1.3 of MLC 2006
recommendation on relevant markets means Recommendation 2007/879/EC and any subsequent Recommendation on relevant markets
notification means the notification to the Commission by a national regulatory authority of a draft measure pursuant to Article 7(3) of Directive 2002/21/EC or a request pursuant to the second subparagraph of Article 8(3) of Directive 2002/19/EC, accompanied by the standard notification form or short notification form as provided in this Recommendation (Annex I and Annex II)
AIFs means collective investment undertakings, including investment compartments thereof, which: (i) raise capital from a number of investors, with a view to investing it in accordance with a defined investment policy for the benefit of those investors and (ii) do not require authorisation pursuant to Article 5 of Directive 2009/65/EC
AIFMs means legal persons whose regular business is managing one or more AIFs
branch when relating to an AIFM means a place of business which is a part of an AIFM, which has no legal personality and which provides the services for which the AIFM has been authorised; all the places of business established in the same Member State by an AIFM with its registered office in another Member State or in a third country shall be regarded as a single branch
carried interest means a share in the profits of the AIF accrued to the AIFM as compensation for the management of the AIF and excluding any share in the profits of the AIF accrued to the AIFM as a return on any investment by the AIFM into the AIF
close links means a situation in which two or more natural or legal persons are linked by: (i) participation, namely ownership, directly or by way of control, of 20% or more of the voting rights or capital of an undertaking; (ii) control, namely the relationship between a parent undertaking and a subsidiary, as referred to in Article 1 of the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts, or a similar relationship between a natural or legal person and an undertaking; for the purposes of this point a subsidiary undertaking of a subsidiary undertaking shall also be considered to be a subsidiary of the parent undertaking of those subsidiaries
competent authorities means the national authorities of Member States which are empowered by law or Regulation to supervise AIFMs
competent authorities in relation to a depositary means: (i) if the depositary is a credit institution authorised under Directive 2006/48/EC, the competent authorities as defined in point (4) of Article 4 thereof; (ii) if the depositary is an investment firm authorised under Directive 2004/39/EC, the competent authorities as defined in point (22) of Article 4(1) thereof; (iii) if the depositary falls within a category of institution referred to in point (c) of the first subparagraph of Article 21(3) of this Directive, the national authorities of its home Member State which are empowered by law or Regulation to supervise such categories of institution; (iv) if the depositary is an entity referred to in the third subparagraph of Article 21(3) of this Directive, the national authorities of the Member State in which that entity has its registered office and which are empowered by law or Regulation to supervise such entity or the official body competent to register or supervise such entity pursuant to the rules of professional conduct applicable thereto; (v) if the depositary is appointed as depositary for a non-EU AIF in accordance with point (b) of Article 21(5) of this Directive and does not fall within the scope of points (i) to (iv) of this point, the relevant national authorities of the third country where the depositary has its registered office
competent authorities of the EU AIF means the national authorities of a Member State which are empowered by law or Regulation to supervise AIFs
control means control as defined in Article 1 of Directive 83/349/EEC
established means: (i) for AIFMs, ‘having its registered office in’; (ii) for AIFs, ‘being authorised or registered in’, or, if the AIF is not authorised or registered, ‘having its registered office in’; (iii) for depositaries, ‘having its registered office or branch in’; (iv) for legal representatives that are legal persons, ‘having its registered office or branch in’; (v) for legal representatives that are natural persons, ‘domiciled in’
EU AIF means: (i) an AIF which is authorised or registered in a Member State under the applicable national law; or (ii) an AIF which is not authorised or registered in a Member State, but has its registered office and/or head office in a Member State
EU AIFM means an AIFM which has its registered office in a Member State
feeder AIF means an AIF which: (i) invests at least 85% of its assets in units or shares of another AIF (the ‘master AIF’); (ii) invests at least 85% of its assets in more than one master AIFs where those master AIFs have identical investment strategies; or (iii) has otherwise an exposure of at least 85% of its assets to such a master AIF
financial instrument means an instrument as specified in Section C of Annex I to Directive 2004/39/EC
holding company means a company with shareholdings in one or more other companies, the commercial purpose of which is to carry out a business strategy or strategies through its subsidiaries, associated companies or participations in order to contribute to their long-term value, and which is either a company: (i) operating on its own account and whose shares are admitted to trading on a regulated market in the Union; or (ii) not established for the main purpose of generating returns for its investors by means of divestment of its subsidiaries or associated companies, as evidenced in its annual report or other official documents
home Member State of the AIF means: (i) the Member State in which the AIF is authorised or registered under applicable national law, or in case of multiple authorisations or registrations, the Member State in which the AIF has been authorised or registered for the first time; or (ii) if the AIF is neither authorised nor registered in a Member State, the Member State in which the AIF has its registered office and/or head office
home Member State of the AIFM means the Member State in which the AIFM has its registered office; for non-EU AIFMs, all references to ‘home Member State of the AIFM’ in this Directive shall be read as the ‘Member State of reference’, as provided for in Chapter VII
host Member State of the AIFM means any of the following: (i) a Member State, other than the home Member State, in which an EU AIFM manages EU AIFs; (ii) a Member State, other than the home Member State, in which an EU AIFM markets units or shares of an EU AIF; (iii) a Member State, other than the home Member State, in which an EU AIFM markets units or shares of a non-EU AIF; (iv) a Member State, other than the Member State of reference, in which a non-EU AIFM manages EU AIFs; (v) a Member State, other than the Member State of reference, in which a non-EU AIFM markets units or shares of an EU AIF; or (vi) a Member State, other than the Member State of reference, in which a non-EU AIFM markets units or shares of a non-EU AIF; or (vii) a Member State, other than the home Member State, in which an EU AIFM provides the services referred to in Article 6(4)
initial capital means funds as referred to in points (a) and (b) of the first paragraph of Article 57 of Directive 2006/48/EC
issuer means an issuer within the meaning of point (d) of Article 2(1) of Directive 2004/109/EC where that issuer has its registered office in the Union, and where its shares are admitted to trading on a regulated market within the meaning of point (14) of Article 4(1) of Directive 2004/39/EC
legal representative means a natural person domiciled in the Union or a legal person with its registered office in the Union, and which, expressly designated by a non-EU AIFM, acts on behalf of such non-EU AIFM vis-à-vis the authorities, clients, bodies and counterparties to the non-EU AIFM in the Union with regard to the non-EU AIFM’s obligations under this Directive
leverage means any method by which the AIFM increases the exposure of an AIF it manages whether through borrowing of cash or securities, or leverage embedded in derivative positions or by any other means
managing AIFs means performing at least investment management functions referred to in point 1(a) or (b) of Annex I for one or more AIFs
marketing means a direct or indirect offering or placement at the initiative of the AIFM or on behalf of the AIFM of units or shares of an AIF it manages to or with investors domiciled or with a registered office in the Union
master AIF means an AIF in which another AIF invests or has an exposure in accordance with point (m)
Member State of reference means the Member State determined in accordance with Article 37(4)
non-EU AIF means an AIF which is not an EU AIF
non-EU AIFM means an AIFM which is not an EU AIFM
non-listed company means a company which has its registered office in the Union and the shares of which are not admitted to trading on a regulated market within the meaning of point (14) of Article 4(1) of Directive 2004/39/EC
own funds means own funds as referred to in Articles 56 to 67 of Directive 2006/48/EC
parent undertaking means a parent undertaking within the meaning of Articles 1 and 2 of Directive 83/349/EEC
prime broker means a credit institution, a regulated investment firm or another entity subject to prudential Regulation and ongoing supervision, offering services to professional investors primarily to finance or execute transactions in financial instruments as counterparty and which may also provide other services such as clearing and settlement of trades, custodial services, securities lending, customised technology and operational support facilities
professional investor means an investor which is considered to be a professional client or may, on request, be treated as a professional client within the meaning of Annex II to Directive 2004/39/EC
qualifying holding means a direct or indirect holding in an AIFM which represents 10% or more of the capital or of the voting rights, in accordance with Articles 9 and 10 of Directive 2004/109/EC, taking into account the conditions regarding aggregation of the holding laid down in Article 12(4) and (5) thereof, or which makes it possible to exercise a significant influence over the management of the AIFM in which that holding subsists
employees’ representatives means employees’ representatives as defined in point (e) of Article 2 of Directive 2002/14/EC
retail investor means an investor who is not a professional investor
subsidiary means a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC
supervisory authorities in relation to non-EU AIFs means the national authorities of a third country which are empowered by law or Regulation to supervise AIFs
supervisory authorities in relation to non-EU AIFMs means the national authorities of a third country which are empowered by law or Regulation to supervise AIFMs;
securitisation special purpose entities means entities whose sole purpose is to carry on a securitisation or securitisations within the meaning of Article 1(2) of Regulation (EC) No 24/2009 of the European Central Bank of 19 December 2008 concerning statistics on the assets and liabilities of financial vehicle corporations engaged in securitisation transactions ( 23 ) and other activities which are appropriate to accomplish that purpose
UCITS means an undertaking for collective investment in transferable securities authorised in accordance with Article 5 of Directive 2009/65/EC
critical infrastructure means an asset, system or part thereof located in Member States which is essential for the maintenance of vital societal functions, health, safety, security, economic or social well-being of people, and the disruption or destruction of which would have a significant impact in a Member State as a result of the failure to maintain those functions
European critical infrastructure or ECI means critical infrastructure located in Member States the disruption or destruction of which would have a significant impact on at least two Member States. The significance of the impact shall be assessed in terms of cross-cutting criteria. This includes effects resulting from cross-sector dependencies on other types of infrastructure
risk analysis means consideration of relevant threat scenarios, in order to assess the vulnerability and the potential impact of disruption or destruction of critical infrastructure
sensitive critical infrastructure protection related information means facts about a critical infrastructure, which if disclosed could be used to plan and act with a view to causing disruption or destruction of critical infrastructure installations
protection means all activities aimed at ensuring the functionality, continuity and integrity of critical infrastructures in order to deter, mitigate and neutralise a threat, risk or vulnerability
owners/operators of ECIs means those entities responsible for investments in, and/or day-to-day operation of, a particular asset, system or part thereof designated as an ECI under this Directive
authoritative source means any source irrespective of its form that can be relied upon to provide accurate data, information and/or evidence that can be used to prove identity
authentication factor means a factor confirmed as being bound to a person, which falls into any of the following categories: (a) ‘possession-based authentication factor’ means an authentication factor where the subject is required to demonstrate possession of it; (b) ‘knowledge-based authentication factor’ means an authentication factor where the subject is required to demonstrate knowledge of it; (c) ‘inherent authentication factor’ means an authentication factor that is based on a physical attribute of a natural person, and of which the subject is required to demonstrate that they have that physical attribute
dynamic authentication means an electronic process using cryptography or other techniques to provide a means of creating on demand an electronic proof that the subject is in control or in possession of the identification data and which changes with each authentication between the subject and the system verifying the subject's identity
information security management system means a set of processes and procedures designed to manage to acceptable levels risks related to information security
node means a connection point which is part of the electronic identification interoperability architecture and is involved in cross-border authentication of persons and which has the capability to recognise and process or forward transmissions to other nodes by enabling the national electronic identification infrastructure of one Member State to interface with national electronic identification infrastructures of other Member States
node operator means the entity responsible for ensuring that the node performs correctly and reliably its functions as a connection point
accelerator means equipment or installation in which particles are accelerated, emitting ionising radiation with energy higher than 1 mega-electron volt (MeV)
accidental exposure means an exposure of individuals, other than emergency workers, as a result of an accident
activation means a process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy photons the material in which it is contained
apprentice means a person receiving training or instruction within an undertaking with a view to exercising a specific skill
authorisation means the registration or licensing of a practice
building material means any construction product for incorporation in a permanent manner in a building or parts thereof and the performance of which has an effect on the performance of the building with regard to exposure of its occupants to ionising radiation
carers and comforters means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone medical exposure
clearance levels means values established by the competent authority or in national legislation, and expressed in terms of activity concentrations, at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of this Directive
clinical audit means a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where appropriate, and the application of new standards if necessary
clinical responsibility means responsibility of a practitioner for individual medical exposures, in particular, justification; optimisation; clinical evaluation of the outcome; cooperation with other specialists and staff, as appropriate, regarding practical aspects of medical radiological procedures; obtaining information, if appropriate, on previous examinations; providing existing medical radiological information and/or records to other practitioners and/or the referrer, as required; and giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate
competent authority means an authority or system of authorities designated by Member States as having legal authority for the purposes of this Directive
consumer product means a device or manufactured item into which one or more radionuclides have deliberately been incorporated or produced by activation, or which generates ionising radiation, and which can be sold or made available to members of the public without special surveillance or regulatory control after sale
contamination means the unintended or undesirable presence of radioactive substances on surfaces or within solids, liquids or gases or on the human body
controlled area means an area subject to special rules for the purpose of protection against ionising radiation or preventing the spread of radioactive contamination and to which access is controlled
diagnostic reference levels means dose levels in medical radiodiagnostic or interventional radiology practices, or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment
disused source means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted but continues to require safe management
absorbed dose (D) is the energy absorbed per unit mass
[ФОРМУЛА1]
where [ФОРМУЛА2] is the mean energy imparted by ionising radiation to the matter in a volume element, dm is the mass of the matter in this volume element. In this Directive, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray (Gy) where one gray is equal to one joule per kilogram:
[ФОРМУЛА3]
activity (A) is the activity of an amount of a radionuclide in a particular energy state at a given time. It is the quotient of dN by dt, where dN is the expectation value of the number of nuclear transitions from that energy state in the time interval dt:
[ФОРМУЛА1]
The unit of activity is the becquerel (Bq)
becquerel (Bq) is the special name of the unit of activity. One becquerel is equivalent to one nuclear transition per second:
[ФОРМУЛА1]
committed effective dose (E(τ)) is the sum of the committed organ or tissue equivalent doses HT(τ) resulting from an intake, each multiplied by the appropriate tissue weighting factor wT. It is defined by:
[ФОРМУЛА1]
In specifying E(τ), is given in the number of years over which the integration is made. For the purpose of complying with dose limits specified in this Directive, is a period of 50 years following intake for adults and up to the age of 70 for infants and children. The unit for committed effective dose is the sievert (Sv)
committed equivalent dose (HT(τ)) is the integral over time (t) of the equivalent dose rate in tissue or organ T that will be received by an individual as a result of an intake. It is given by:
[ФОРМУЛА1]
for an intake at time t0 where
[ФОРМУЛА2]
is the relevant equivalent dose rate in organ or tissue T at time t,
τ is the time over which the integration is performed. In specifying HT(τ), is given in number of years over which the integration is made. For the purpose of complying with dose limits specified in this Directive, τ is a period of 50 years for adults and up to the age of 70 for infants and children. The unit for committed equivalent dose is the sievert (Sv)
dose constraint means a constraint set as a prospective upper bound of individual doses, used to define the range of options considered in the process of optimisation for a given radiation source in a planned exposure situation
dose limit means the value of the effective dose (where applicable, committed effective dose) or the equivalent dose in a specified period which shall not be exceeded for an individual
dosimetry service means a body or an individual competent to calibrate, read or interpret individual monitoring devices, or to measure radioactivity in the human body or in biological samples, or to assess doses, whose capacity to act in this respect is recognised by the competent authority
effective dose (E) is the sum of the weighted equivalent doses in all the tissues and organs of the body from internal and external exposure. It is defined by the expression:
[ФОРМУЛА1]
where DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, wR is the radiation weighting factor and wT is the tissue weighting factor for tissue or organ T. The values for wT and wR are specified in Annex II. The unit for effective dose is the sievert (Sv)
emergency means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences
emergency exposure situation means a situation of exposure due to an emergency
emergency management system means a legal or administrative framework establishing responsibilities for emergency preparedness and response, and arrangements for Decision making in the event of an emergency exposure situation
emergency occupational exposure means exposure received in an emergency exposure situation by an emergency worker
emergency response plan means arrangements to plan for adequate response in the event of an emergency exposure situation on the basis of postulated events and related scenarios
emergency worker means any person having a defined role in an emergency and who might be exposed to radiation while taking action in response to the emergency
environmental monitoring means the measurement of external dose rates due to radioactive substances in the environment or of concentrations of radionuclides in environmental media
equivalent dose (HT) is the absorbed dose, in tissue or organ T weighted for the type and quality of radiation R. It is given by:
[ФОРМУЛА1]
where DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R, wR is the radiation weighting factor. When the radiation field is composed of types and energies with different values of wR, the total equivalent dose, HT, is given by:
[ФОРМУЛА2]
The values for wR are specified in Annex II, Part A. The unit for equivalent dose is the sievert (Sv)
exemption level means a value established by a competent authority or in legislation and expressed in terms of activity concentration or total activity at or below which a radiation source is not subject to notification or authorisation
existing exposure situation means an exposure situation that already exists when a Decision on its control has to be taken and which does not call or no longer calls for urgent measures to be taken
exposed worker means a person, either self-employed or working under an employer, who is subject to exposure at work carried out within a practice regulated by this Directive and who is liable to receive doses exceeding one or other of the dose limits for public exposure
exposure means the act of exposing or condition of being exposed to ionising radiation emitted outside the body (external exposure) or within the body (internal exposure)
extremities means the hands, forearms, feet and ankles
health detriment means reduction in length and quality of life occurring in a population following exposure, including those arising from tissue reactions, cancer and severe genetic disorder
health screening means a procedure using medical radiological installations for early diagnosis in population groups at risk
high-activity sealed source means a sealed source for which the activity of the contained radionuclide is equal to or exceeds the relevant activity value laid down in Annex III
individual detriment means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance
inspection means an investigation by or on behalf of any competent authority to verify compliance with national legal requirements
intake means the total activity of a radionuclide entering the body from the external environment
interventional radiology means the use of X-ray imaging techniques to facilitate the introduction and guidance of devices in the body for diagnostic or treatment purposes
ionising radiation means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly
licence means permission granted in a document by the competent authority to carry out a practice in accordance with specific conditions laid down in that document
medical exposure means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research
medical physics expert means an individual or, if provided for in national legislation, a group of individuals, having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to medical exposure, whose competence in this respect is recognised by the competent authority
medical radiological means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes
medical radiological installation means a facility where medical radiological procedures are performed
medical radiological procedure means any procedure giving rise to medical exposure
members of the public means individuals who may be subject to public exposure
natural radiation source means a source of ionising radiation of natural, terrestrial or cosmic origin
non-medical imaging exposure means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed
normal exposure means exposure expected to occur under the normal operating conditions of a facility or activity (including maintenance, inspection, deCommissioning), including minor incidents that can be kept under control, i.e. during normal operation and anticipated operational occurrences
notification means submission of information to the competent authority to notify the intention to carry out a practice within the scope of this Directive
occupational exposure means exposure of workers, apprentices and students, incurred in the course of their work
occupational health service means a health professional or body competent to perform medical surveillance of exposed workers and whose capacity to act in that respect is recognised by the competent authority
orphan source means a radioactive source which is neither exempted nor under regulatory control, e.g. because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorisation
outside worker means any exposed worker who is not employed by the undertaking responsible for the supervised and controlled areas, but performs activities in those areas, including, apprentices and students
planned exposure situation means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters exposure pathways, so as to cause the exposure or potential exposure of people or the environment. Planned exposure situations may include both normal exposures and potential exposures
potential exposure means exposure that is not expected with certainty but may result from an event or sequence of events of a probabilistic nature, including equipment failures and operating errors
practical aspects of medical radiological procedures means the physical conduct of a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, and image processing
practice means a human activity that can increase the exposure of individuals to radiation from a radiation source and is managed as a planned exposure situation
practitioner means a medical doctor, dentist or other health professional who is entitled to take clinical responsibility for an individual medical exposure in accordance with national requirements
processing means chemical or physical operations on radioactive material including the mining, conversion, enrichment of fissile or fertile nuclear material and the reprocessing of spent fuel
protective measures means measures, other than remedial measures, for the purpose of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation
public exposure means exposure of individuals, excluding any occupational or medical exposure
quality assurance means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with agreed standards. Quality control is a part of quality assurance
quality control means the set of operations (programming, coordinating, Implementing) intended to maintain or to improve quality. It includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled
radiation generator means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particle
radiation protection expert means an individual or, if provided for in the national legislation, a group of individuals having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, and whose competence in this respect is recognised by the competent authority
radiation protection officer means an individual who is technically competent in radiation protection matters relevant for a given type of practice to supervise or perform the implementation of the radiation protection arrangements
radiation source means an entity that may cause exposure, such as by emitting ionising radiation or by releasing radioactive material
radioactive material means material incorporating radioactive substances
radioactive source means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity
radioactive substance means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view
radioactive waste means radioactive material in gaseous, liquid or solid form for which no further use is foreseen or considered by the Member State or by a legal or natural person whose Decision is accepted by the Member State, and which is regulated as radioactive waste by a competent regulatory authority under the legislative and regulatory framework of the Member State
radiodiagnostic means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology
radiotherapeutic means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes
radon means the radionuclide Rn-222 and its progeny, as appropriate
exposure to radon means exposure to radon progeny
reference level means in an emergency exposure situation or in an existing exposure situation, the level of effective dose or equivalent dose or activity concentration above which it is judged inappropriate to allow exposures to occur as a result of that exposure situation, even though it is not a limit that may not be exceeded
referrer means a medical doctor, dentist or other health professional who is entitled to refer individuals for medical radiological procedures to a practitioner, in accordance with national requirements
registration means permission granted in a document by the competent authority, or granted by national legislation, through a simplified procedure, to carry out a practice in accordance with conditions laid down in national legislation or specified by a competent authority for this type or class of practice
regulatory control means any form of control or Regulation applied to human activities for the enforcement of radiation protection requirements
remedial measures means the removal of a radiation source or the reduction of its magnitude (in terms of activity or amount) or the interruption of exposure pathways or the reduction of their impact for the purposes of avoiding or reducing doses that might otherwise be received in an existing exposure situation
representative person means an individual receiving a dose that is representative of the more highly exposed individuals in the population, excluding those individuals having extreme or rare habits
sealed source means a radioactive source in which the radioactive material is permanently sealed in a capsule or incorporated in a solid form with the objective of preventing, under normal conditions of use, any dispersion of radioactive substances
sievert (Sv) is the special name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram:
[ФОРМУЛА1]
storage means the holding of radioactive material, including spent fuel, a radioactive source or radioactive waste, in a facility with the intention of retrieval
supervised area means an area subject to supervision for the purpose of protection against ionising radiation
source container means an assembly of components intended to guarantee the containment of a sealed source, where it is not an integral part of the source but is meant for shielding the source during its transport and handling
spacecraft means a manned vehicle designed to operate at an altitude of more than 100 km above sea level
standard values and relationships means values and relationships recommended in chapters 4 and 5 of ICRP Publication 116 for the estimation of doses from external exposure and chapter 1 of ICRP Publication 119 for the estimation of doses from internal exposure, including updates approved by Member States. Member State may approve the use of specific methods in specified cases relating to the physico-chemical properties of the radionuclide or other features of the exposure situation or of the exposed individual
thoron means the radionuclide Rn-220 and its progeny, as appropriate
undertaking means a natural or legal person who has legal responsibility under national law for carrying out a practice, or for a radiation source (including cases where the owner or holder of a radiation source does not conduct related human activities)
unintended exposure means medical exposure that is significantly different from the medical exposure intended for a given purpose
customs authorities means the customs administrations of the Member States responsible for applying the customs legislation and any other authorities empowered under national law to apply certain customs legislation
customs legislation means the body of legislation made up of all of the following: (a) the Code and the provisions supplementing or Implementing it adopted at Union or national level; (b) the Common Customs Tariff; (c) the legislation setting up a Union system of reliefs from customs duty; (d) international agreements containing customs provisions, insofar as they are applicable in the Union
customs controls means specific acts performed by the customs authorities in order to ensure compliance with the customs legislation and other legislation governing the entry, exit, transit, movement, storage and end-use of goods moved between the customs territory of the Union and countries or territories outside that territory, and the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure
person means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under Union or national law as having the capacity to perform legal acts
economic operator means a person who, in the course of his or her business, is involved in activities covered by the customs legislation
customs representative means any person appointed by another person to carry out the acts and formalities required under the customs legislation in his or her dealings with customs authorities
risk means the likelihood and the impact of an event occurring, with regard to the entry, exit, transit, movement or end-use of goods moved between the customs territory of the Union and countries or territories outside that territory and to the presence within the customs territory of the Union of non-Union goods, which would (a) prevent the correct application of Union or national measures; (b) compromise the financial interests of the Union and its Member States; or (c) pose a threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers
customs formalities means all the operations which must be carried out by a person and by the customs authorities in order to comply with the customs legislation
entry summary declaration means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be brought into the customs territory of the Union
exit summary declaration means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be taken out of the customs territory of the Union
temporary storage declaration means the act whereby a person indicates, in the prescribed form and manner, that goods are in temporary storage
customs declaration means the act whereby a person indicates, in the prescribed form and manner, a wish to place goods under a given customs procedure, with an indication, where appropriate, of any specific arrangements to be applied
re-export declaration means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods, with the exception of those under the free zone procedure or in temporary storage, out of the customs territory of the Union
re-export notification means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods which are under the free zone procedure or in temporary storage out of the customs territory of the Union
declarant means the person lodging a customs declaration, a temporary storage declaration, an entry summary declaration, an exit summary declaration, a re-export declaration or a re-export notification in his or her own name or the person in whose name such a declaration or notification is lodged
customs procedure means any of the following procedures under which goods may be placed in accordance with the Code: (a) release for free circulation; (b) special procedures; (c) export
temporary storage means the situation of non-Union goods temporarily stored under customs supervision in the period between their presentation to customs and their placing under a customs procedure or re-export
customs debt means the obligation on a person to pay the amount of import or export duty which applies to specific goods under the customs legislation in force
debtor means any person liable for a customs debt
import duty means customs duty payable on the import of goods
export duty means customs duty payable on the export of goods
customs status means the status of goods as Union or non-Union goods
Union goods means goods which fall into any of the following categories: (a) goods wholly obtained in the customs territory of the Union and not incorporating goods imported from countries or territories outside the customs territory of the Union; (b) goods brought into the customs territory of the Union from countries or territories outside that territory and released for free circulation; (c) goods obtained or produced in the customs territory of the Union, either solely from goods referred to in point (b) or from goods referred to in points (a) and (b)
non-Union goods means goods other than those referred to in point 23 or which have lost their customs status as Union goods
risk management means the systematic identification of risk, including through random checks, and the implementation of all measures necessary for limiting exposure to risk
release of goods means the act whereby the customs authorities make goods available for the purposes specified for the customs procedure under which they are placed
customs supervision means action taken in general by the customs authorities with a view to ensuring that customs legislation and, where appropriate, other provisions applicable to goods subject to such action are observed
repayment means the refunding of an amount of import or export duty that has been paid
remission means the waiving of the obligation to pay an amount of import or export duty which has not been paid
processed products means goods placed under a processing procedure which have undergone processing operations
person established in the customs territory of the Union means: (a) in the case of a natural person, any person who has his or her habitual residence in the customs territory of the Union; (b) in the case of a legal person or an association of persons, any person having its registered office, central headquarters or a permanent business establishment in the customs territory of the Union
permanent business establishment means a fixed place of business, where both the necessary human and technical resources are permanently present and through which a person's customs-related operations are wholly or partly carried out
presentation of goods to customs means the notification to the customs authorities of the arrival of goods at the customs office or at any other place designated or approved by the customs authorities and the availability of those goods for customs controls
holder of the goods means the person who is the owner of the goods or who has a similar right of disposal over them or who has physical control of them
holder of the procedure means: (a) the person who lodges the customs declaration, or on whose behalf that declaration is lodged; or (b) the person to whom the rights and obligations in respect of a customs procedure have been transferred
commercial policy measures means non-tariff measures established, as part of the common commercial policy, in the form of Union provisions governing international trade in goods
processing operations means any of the following: (a) the working of goods, including erecting or assembling them or fitting them to other goods; (b) the processing of goods; (c) the destruction of goods; (d) the repair of goods, including restoring them and putting them in order; (e) the use of goods which are not to be found in the processed products, but which allow or facilitate the production of those products, even if they are entirely or partially used up in the process (production accessories)
rate of yield means the quantity or percentage of processed products obtained from the processing of a given quantity of goods placed under a processing procedure
Decision means any act by the customs authorities pertaining to the customs legislation giving a ruling on a particular case, and having legal effects on the person or persons concerned
carrier means: (a) in the context of entry, the person who brings the goods, or who assumes responsibility for the carriage of the goods, into the customs territory of the Union. However, (i) in the case of combined transportation, "carrier" means the person who operates the means of transport which, once brought into the customs territory of the Union, moves by itself as an active means of transport; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, "carrier" means the person who concludes a contract and issues a bill of lading or air waybill for the actual carriage of the goods into the customs territory of the Union; (b) in the context of exit, the person who takes the goods, or who assumes responsibility for the carriage of the goods, out of the customs territory of the Union. However: (i) in the case of combined transportation, where the active means of transport leaving the customs territory of the Union is only transporting another means of transport which, after the arrival of the active means of transport at its destination, will move by itself as an active means of transport, 'carrier' means the person who will operate the means of transport which will move by itself once the means of transport leaving the customs territory of the Union has arrived at its destination; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, "carrier" means the person who concludes a contract, and issues a bill of lading or air waybill, for the actual carriage of the goods out of the customs territory of the Union
buying Commission means a fee paid by an importer to an agent for representing him or her in the purchase of goods being valued
power-driven vehicle means any self-propelled vehicle running on a road under its own power, other than a rail-borne vehicle
mopeds two-wheel vehicles or three-wheel vehicles with a maximum design speed of not more than 45 km/h, as defined in Article 1(2)(a) of Directive 2002/24/EC of the Europen Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (excluding those with a maximum design speed under or equal to 25 km/h), and light quadricycles as defined in Article 1(3)(a) of Directive 2002/24/EC
motorcycle means two-wheel vehicles with or without a sidecar, as defined in Article 1(2)(b) of Directive 2002/24/EC
motor tricycle means vehicles with three symmetrically arranged wheels, as defined in Article 1(2)(c) of Directive 2002/24/EC
motor vehicle means any power-driven vehicle, which is normally used for carrying persons or goods by road or for drawing, on the road, vehicles used for the carriage of persons or goods. This term shall include trolleybuses, i.e. vehicles connected to an electric conductor and not rail-borne. It shall not include agricultural or forestry tractors
agricultural or forestry tractor means any power-driven vehicle running on wheels or tracks, having at least two axles, the principal function of which lies in its tractive power, which is specially designed to pull, push, carry or operate certain tools, machines or trailers used in connection with agricultural or forestry operations, and the use of which for carrying persons or goods by road or drawing, on the road, vehicles used for the carriage of persons or goods is only a secondary function
ship means a ship falling within the scope of the international conventions
international conventions means the International Convention for the Safety of Life at Sea of 1 November 1974 (SOLAS 74) with the exception of chapter XI-2 of the Annex thereto, the International Convention on Load Lines of 5 April 1966 and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (MARPOL), together with the protocols and amendments thereto, and the related codes of mandatory status in all Member States, with the exception of paragraphs 16.1, 18.1 and 19 of part 2 of the IMO Instruments Implementation Code, and of sections 1.1, 1.3, 3.9.3.1, 3.9.3.2 and 3.9.3.3 of part 2 of the IMO Code for Recognized Organizations, in their up-to-date version
organisation means a legal entity, its subsidiaries and any other entities under its control, which jointly or separately carry out tasks falling under the scope of this Regulation
control means, for the purpose of point (c), rights, contracts or any other means, in law or in fact, which, either separately or in combination confer the possibility of exercising decisive influence on a legal entity or enable that entity to carry out tasks falling under the scope of this Regulation
recognised organisation means an organisation recognised in accordance with this Regulation
authorisation means an act whereby a Member State grants an authorisation or delegates powers to a recognised organisation
statutory certificate means a certificate issued by or on behalf of a flag State in accordance with the international conventions
rules and procedures means a recognised organisation’s requirements for the design, construction, equipment, maintenance and survey of ships
class certificate means a document issued by a recognised organisation certifying the fitness of a ship for a particular use or service in accordance with the rules and procedures laid down and made public by that recognised organisation
location means the place of the registered office, central administration or principal place of business of an organisation
fruit juice The fermentable but unfermented product obtained from the edible part of fruit which is sound and ripe, fresh or preserved by chilling or freezing of one or more kinds mixed together having the characteristic colour, flavour and taste typical of the juice of the fruit from which it comes. Flavour, pulp, and cells obtained by suitable physical means from the same species of fruit may be restored to the juice. In the case of citrus fruits, the fruit juice must come from the endocarp. Lime juice, however, may be obtained from the whole fruit. Where juices are processed from fruits with pips, seeds and peel, parts or components of pips, seeds and peel shall not be incorporated in the juice. This provision shall not apply to cases where parts or components of pips, seeds and peel cannot be removed by good manufacturing practices. The mixing of fruit juice with fruit purée is authorised in the production of the fruit juice.
fruit juice from concentrate The product obtained by reconstituting concentrated fruit juice defined in point 2 with potable water that meets the criteria set out in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. The soluble solids content of the finished product shall meet the minimum Brix level for reconstituted juice specified in Annex V. If a juice from concentrate is manufactured from a fruit not mentioned in Annex V, the minimum Brix level of the reconstituted juice shall be the Brix level of the juice as extracted from the fruit used to make the concentrate. Flavour, pulp and cells obtained by suitable physical means from the same species of fruit may be restored to the fruit juice from concentrate. The fruit juice from concentrate is prepared by suitable processes, which maintain the essential physical, chemical, organoleptical and nutritional characteristics of an average type of juice of the fruit from which it comes. The mixing of fruit juice and/or concentrated fruit juice with fruit purée and/or concentrated fruit purée is authorised in the production of fruit juice from concentrate.
concentrated fruit juice The product obtained from fruit juice of one or more fruit species by the physical removal of a specific proportion of the water content. Where the product is intended for direct consumption, the removal shall be at least 50% of the water content. Flavour, pulp and cells obtained by suitable physical means from the same species of fruit may be restored to the concentrated fruit juice.
water extracted fruit juice The product obtained by diffusion with water of: pulpy whole fruit whose juice cannot be extracted by any physical means, or dehydrated whole fruit.
dehydrated/powdered fruit juice The product obtained from fruit juice of one or more fruit species by the physical removal of virtually all the water content.
fruit nectar The fermentable but unfermented product which: is obtained by adding water with or without the addition of sugars and/or honey to the products defined in points 1 to 4 to fruit purée and/or to concentrated fruit purée and/or to a mixture of those products, and meets the requirements of Annex IV. Without prejudice to Regulation (EC) No 1924/2006 of the Europen Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods ( 13 ), where fruit nectars are manufactured without added sugars or with reduced energy value, sugars may be replaced wholly or partially by sweeteners, in accordance with Regulation (EC) No 1333/2008. Flavour, pulp and cells obtained by suitable physical means from the same species of fruit may be restored to the fruit nectar.
fruit All fruits. For the purposes of this Directive, tomatoes are also considered as fruit. The fruit shall be sound, appropriately mature, and fresh or preserved by physical means or by treatment(s), including post-harvest treatments applied in accordance with Union law.
fruit purée The fermentable but unfermented product obtained by suitable physical processes such as sieving, grinding, milling the edible part of whole or peeled fruit without removing the juice.
concentrated fruit purée The product obtained from fruit purée by the physical removal of a specific proportion of its water content. Concentrated fruit purée may have restored flavour which shall be obtained by suitable physical means, as defined in point 3 of Part II of Annex I and all of which must be recovered from the same species of fruit.
flavour Without prejudice to Regulation (EC) No 1334/2008 of the Europen Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods, flavours for restoration are obtained during the processing of the fruit by applying suitable physical processes. Those physical processes may be applied to retain, preserve or stabilise the flavour quality and include in particular squeezing, extraction, distillation, filtration, adsorption, evaporation, fractionation and concentration. Flavour is obtained from the edible parts of the fruit; however it could also be cold pressed oil from citrus peel and compounds from the stones.
sugars sugars as defined by Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption, fructose syrup, sugars derived from fruits.
honey The product defined by Council Directive 2001/110/EC of 20 December 2001 relating to honey
pulp or cells The products obtained from the edible parts of fruit of the same species without removing the juice. Furthermore, for citrus fruit, pulp or cells are the juice sacs obtained from the endocarp.
vessel any vessel flying the flag of a Member State or registered under the plenary jurisdiction of a Member State, seagoing or estuary-fishing, publicly or privately owned, excluding: inland navigation vessels, warships, pleasure boats used for non-commercial purposes and not manned by professional crews, tugs operating in harbour areas. Vessels shall be classed in three categories in accordance with Annex I
worker any person carrying out an occupation on board a vessel, including trainees and apprentices, but excluding port pilots and shore personnel carrying out work on board a vessel at the quayside
owner the registered owner of a vessel unless that vessel has been chartered by demise or is managed, either wholly or in part, by a natural or legal person other than the registered owner under the terms of a management agreement; in that case the owner shall be construed as the demise charterer or natural or legal person managing the vessel as appropriate
medical supplies medicines, medical equipment and antidotes, a non-exhaustive list of which is given in Annex II
antidote a substance used to prevent or treat a harmful effect or effects, direct or indirect, of one or more substances included on the list of dangerous substances in Annex III
coffee extract, soluble coffee extract, soluble coffee or instant coffee This means the concentrated product obtained by extraction from roasted coffee beans using only water as the medium of extraction and excluding any process of hydrolysis involving the addition of an acid or a base. Apart from those insoluble substances which it is technically impossible to remove, and insoluble oils derived from coffee, coffee extract must contain only the soluble and aromatic constituents of coffee. Member States shall ensure that the methods used to determine the free and total carbohydrate content of soluble coffees are in conformity with paragraphs 1 and 2 of the Annex to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption and that they are validated or standardised, either already or as soon as possible. The coffee-based dry matter content must be: (a) not less than 95% by weight in the case of dried coffee extract; (b) from 70% to 85% by weight in the case of coffee extract paste; (c) from 15% to 55% by weight in the case of liquid coffee extract. Coffee extract in solid or paste form must contain no substances other than those derived from the extraction of coffee. Liquid coffee extract may contain edible sugars, whether or not roasted, in a proportion not exceeding 12% by weight.
chicory extract, soluble chicory or instant chicory This means the concentrated product obtained by extraction from roasted chicory using only water as the medium of extraction and excluding any process of hydrolysis involving the addition of an acid or a base. ‘Chicory’ means the roots of Cichorium Intybus L., not used for the production of witloof chicory, usually used for the preparation of beverages, suitably cleaned to be dried and roasted. The chicory-based dry matter content must be: (a) not less than 95% by weight in the case of dried chicory extract; (b) from 70% to 85% by weight in the case of chicory extract paste; (c) from 25% to 55% by weight in the case of liquid chicory extract. Chicory extract in solid or paste form may contain not more than 1% by weight of substances not derived from chicory. Liquid chicory extract may contain edible sugars, whether roasted or not, to a proportion not exceeding 35% by weight.
honey is the natural sweet substance produced by Apis mellifera bees from the nectar of plants or from secretions of living parts of plants or excretions of plant-sucking insects on the living parts of plants, which the bees collect, transform by combining with specific substances of their own, deposit, dehydrate, store and leave in honeycombs to ripen and mature
baker’s honey honey which is (a) suitable for industrial uses or as an ingredient in other foodstuffs which are then processed and (b) may: have a foreign taste or odour, or have begun to ferment or have fermented, or have been overheated
tachograph or recording equipment means the equipment intended for installation in road vehicles to display, record, print, store and output automatically or semi-automatically details of the movement, including the speed, of such vehicles, in accordance with Article 4(3), and details of certain periods of activity of their drivers
vehicle unit means the tachograph excluding the motion sensor and the cables connecting the motion sensor. The vehicle unit may be a single unit or several units distributed in the vehicle, provided that it complies with the security requirements of this Regulation; the vehicle unit includes, among other things, a processing unit, a data memory, a time measurement function, two smart card interface devices for driver and co-driver, a printer, a display, connectors and facilities for entering the user’s inputs
motion sensor means a part of the tachograph providing a signal representative of vehicle speed and/or distance travelled
tachograph card means a smart card, intended for use with the tachograph, which allows identification by the tachograph of the role of the cardholder and allows data transfer and storage
record sheet means a sheet designed to accept and retain recorded data, to be placed in an analogue tachograph, and on which the marking devices of the analogue tachograph continuously inscribe the information to be recorded
driver card means a tachograph card, issued by the authorities of a Member State to a particular driver, which identifies the driver and allows for the storage of driver activity data
analogue tachograph means a tachograph using a record sheet in accordance with this Regulation
digital tachograph means a tachograph using a tachograph card in accordance with this Regulation
control card means a tachograph card issued by the authorities of a Member State to a national competent control authority which identifies the control body and, optionally, the control officer, and which allows access to the data stored in the data memory or in the driver cards and, optionally, in the workshop cards for reading, printing and/or downloading
company card means a tachograph card issued by the authorities of a Member State to a transport undertaking needing to operate vehicles fitted with a tachograph, which identifies the transport undertaking and allows for the displaying, downloading and printing of the data, stored in the tachograph, which have been locked by that transport undertaking
workshop card means a tachograph card issued by the authorities of a Member State to designated staff of a tachograph manufacturer, a fitter, a vehicle manufacturer or a workshop, approved by that Member State, which identifies the cardholder and allows for the testing, calibration and activation of tachographs, and/or downloading from them
activation means the phase in which the tachograph becomes fully operational and implements all functions, including security functions, through the use of a workshop card
calibration of a digital tachograph means updating or confirming vehicle parameters, including vehicle identification and vehicle characteristics, to be held in the data memory through the use of a workshop card
downloading from a digital tachograph means the copying, together with the digital signature, of a part, or of a complete set, of data files recorded in the data memory of the vehicle unit or in the memory of a tachograph card, provided that this process does not alter or delete any stored data
event means an abnormal operation detected by the digital tachograph which may result from a fraud attempt
fault means an abnormal operation detected by the digital tachograph which may result from an equipment malfunction or failure
installation means the mounting of a tachograph in a vehicle
non-valid card means a card detected as faulty, or whose initial authentication failed, or whose start of validity date is not yet reached, or whose expiry date has passed
periodic inspection means a set of operations performed to check that the tachograph works properly, that its settings correspond to the vehicle parameters, and that no manipulation devices are attached to the tachograph
repair means any repair of a motion sensor or of a vehicle unit that requires the disconnection of its power supply, or its disconnection from other tachograph components, or the opening of the motion sensor or vehicle unit
type-approval means a process to certify, by a Member State, in accordance with Article 13, that the tachograph, its relevant components or the tachograph card to be introduced to market fulfil the requirements of this Regulation
interoperability means the capacity of systems and the underlying business processes to exchange data and to share information
interface means a facility between systems which provides the media through which they can connect and interact
time measurement means a permanent digital record of the coordinated universal date and time (UTC)
time adjustment means an automatic adjustment of current time at regular intervals and within a maximum tolerance of one minute, or an adjustment performed during calibration
open standard means a standard set out in a standard specification document available freely or at a nominal charge which it is permissible to copy, distribute or use for no fee or for a nominal fee
recording equipment or analogue tachograph means equipment intended for installation in road vehicles to show and record automatically or semi-automatically details of the movement of such vehicles and details of certain periods of activity of their drivers
constant of the recording equipment means the numerical characteristic giving the value of the input signal required to show and record a distance travelled of one kilometre; this constant must be expressed either in revolutions per kilometre (k = … rev/km), or in impulses per kilometre (k = … imp/km)
characteristic coefficient means the numerical characteristic giving the value of the output signal emitted by the part of the vehicle linking it with the recording equipment (gearbox output shaft or axle) while the vehicle travels a distance of one measured kilometre under normal test conditions (see point 4 of Part VI of this Annex). The characteristic coefficient is expressed either in revolutions per kilometre (w = … rev/km) or in impulses per kilometre (w = … imp/km)
effective circumference of wheel tyres means the average of the distances travelled by the several wheels moving the vehicle (driving wheels) in the course of one complete rotation. The measurement of these distances must take place under normal test conditions (see point 4 of Part VI of this Annex) and is expressed in the form: l = … mm
semi-white sugar purified and crystallised sucrose of sound and fair marketable quality with the following characteristics: (a) polarisation - not less than 99,5 °Z; (b) invert sugar content - not more than 0,1% by weight; (c) loss on drying - not more than 0,1% by weight
sugar or white sugar purified and crystallised sucrose of sound and fair marketable quality with the following characteristics: (a) polarisation - not less than 99,7 °Z; (b) invert sugar content - not more than 0,04% by weight; (c) loss on drying - not more than 0,06% by weight; (d) type of colour - not more than nine points determined in accordance with point (a) of Part B.
extra-white sugar the product having the characteristics referred to in point 2(a), (b) and (c) and in respect of which the total number of points determined according to the provisions of Part B does not exceed eight, and not more than: four for the colour type, six for the ash content, three for the colour in solution
sugar solution the aqueous solution of sucrose with the following characteristics: (a) dry matter - not less than 62% by weight; (b) invert sugar content (ratio of fructose to dextrose: 1,0 ± 0,2) - not more than 3% by weight of dry matter; (c) conductivity ash - not more than 0,1% by weight of dry matter, determined in accordance with point (b) of Part B; (d) colour in solution - not more than 45 ICUMSA units
invert sugar solution the aqueous solution of sucrose partially inverted by hydrolysis, in which the proportion of invert sugar does not predominate, with the following characteristics: (a) dry matter - not less than 62% by weight; (b) invert sugar content ratio of fructose to dextrose (1,0 ± 0,1) - more than 3% but not more than 50% by weight of dry matter; (c) conductivity ash - not more than 0,4% by weight of dry matter, determined in accordance with point (b) of Part B
invert sugar syrup the aqueous solution, which has possibly been crystallised, of sucrose that has been partly inverted via hydrolysis, in which the invert sugar content (fructose/dextrose quotient 1,0 ± 0,1), must exceed 50% by weight of dry matter, but which must otherwise meet the requirements laid down in point 5(a) and (c)
glucose syrup the purified and concentrated aqueous solution of nutritive saccharides obtained from starch and/or inulin, with the following characteristics: (a) dry matter - not less than 70% by weight; (b) dextrose equivalent - not less than 20% by weight of dry matter and expressed as D-glucose; (c) sulphated ash - not more than 1% by weight of dry matter
dried glucose syrup partially dried glucose syrup with at least 93% by weight of dry matter, but which must otherwise meet the requirements laid down in point 7(b) and (c)
dextrose or dextrose monohydrate purified and crystallised D-glucose containing one molecule of water of crystallisation, with the following characteristics: (a) dextrose (D-glucose) - not less than 99,5% by weight of dry matter; (b) dry matter - not less than 90% by weight; (c) sulphated ash - not more than 0,25% by weight of dry matter
dextrose or dextrose anhydrous purified and crystallised D-glucose not containing water of crystallisation, with at least 98% by weight of dry matter, but which must otherwise meet the requirements laid down in point 9(a) and (c).
fructose purified crystallised D-fructose with the following characteristics: fructose content - 98% minimum; glucose content - 0,5% maximum; loss on drying - not more than 0,5% by weight; conductivity ash - not more than 0,1% by weight determined in accordance with point (b) of Part B
exceptional event means any unplanned event that is not reasonably controllable or preventable and that may cause, for a limited period, capacity reductions, affecting thereby the quantity or quality of gas at a given interconnection point, with possible consequences on interactions between transmission system operators as well as between transmission system operator and network users
initiating transmission system operator means the transmission system operator initiating the matching process by sending the necessary data to the matching transmission system operator
lesser rule means that, in case of different processed quantities at either side of an interconnection point, the confirmed quantity will be equal to the lower of the two processed quantities
matching process is the process of comparing and aligning processed quantities of gas for network users at both sides of a specific interconnection point, which results in confirmed quantities for the network users
matching transmission system operator means the transmission system operator performing the matching process and sending the result of the matching process to the initiating transmission system operator
measured quantity means the quantity of gas that, according to the measurement equipment from the transmission system operator, has physically flowed across an interconnection point per time period
operational balancing account means an account between adjacent transmission system operators, to be used to manage steering differences at an interconnection point in order to simplify gas accounting for network users involved at the interconnection point
processed quantity means the quantity of gas determined by the initiating transmission system operator and by the matching transmission system operator, which takes into account the network user's nomination or re-nomination and contractual provisions as defined under the relevant transport contract and which is used as the basis for the matching process
steering difference means the difference between the quantity of gas that the transmission system operators had scheduled to flow and the measured quantity for an interconnection point
jam is a mixture, brought to a suitable gelled consistency, of sugars, the pulp and/or purée of one or more kinds of fruit and water. However, citrus jam may be obtained from the whole fruit, cut into strips and/or sliced. The quantity of pulp and/or purée used for the manufacture of 1000 g of finished product must not be less than: 350 g as a general rule, 250 g for redcurrants, rowanberries, sea-buckthorns, blackcurrants, rosehips and quinces, 150 g for ginger, 160 g for cashew apples, 60 g for passion fruit
extra jam is a mixture, brought to a suitable gelled consistency, of sugars, the unconcentrated pulp of one or more kinds of fruit and water. However, rosehip extra jam and seedless raspberry, blackberry, blackcurrant, blueberry and redcurrant extra jam may be obtained entirely or in part from unconcentrated purée of the respective fruits. Citrus extra jam may be obtained from the whole fruit, cut into strips and/or sliced. The following fruits may not be used mixed with others in the manufacture of extra jam: apples, pears, clingstone plums, melons, water-melons, grapes, pumpkins, cucumbers and tomatoes. The quantity of pulp used for the manufacture of 1 000 g of finished product must not be less than: 450 g as a general rule, 350 g for redcurrants, rowanberries, sea-buckthorns, blackcurrants, rosehips and quinces, 250 g for ginger, 230 g for cashew apples, 80 g for passion fruit
jelly is an appropriately gelled mixture of sugars and the juice and/or aqueous extracts of one or more kinds of fruit. The quantity of juice and/or aqueous extracts used in the manufacture of 1 000 g of finished product must not be less than that laid down for the manufacture of jam. These quantities are calculated after deduction of the weight of water used in preparing the aqueous extracts. In the case of ‘extra jelly’, however, the quantity of fruit juice and/or aqueous extracts used in the manufacture of 1 000 g of finished product must not be less than that laid down for the manufacture of extra jam. These quantities are calculated after deduction of the weight of water used in preparing the aqueous extracts. The following fruits may not be used mixed with others in the manufacture of extra jelly: apples, pears, clingstone plums, melons, water-melons, grapes, pumpkins, cucumbers and tomatoes
marmalade is a mixture, brought to a suitable gelled consistency, of water, sugars and one or more of the following products obtained from citrus fruit: pulp, purée, juice, aqueous extracts and peel. The quantity of citrus fruit used in the manufacture of 1 000 g of finished product must not be less than 200 g of which at least 75 g must be obtained from the endocarp. The name ‘jelly marmalade’ may be used where the product contains no insoluble matter except possibly for small quantities of finely sliced peel
sweetened chestnut purée is a mixture, brought to a suitable consistency, of water, sugar and at least 380 g of chestnut (Castanea sativa) purée for 1 000 g of finished product
fruit fresh, sound fruit, free from deterioration, containing all its essential constituents and sufficiently ripe for use, after cleaning, removal of blemishes, topping and tailing; for the purposes of this Directive, tomatoes, the edible parts of rhubarb stalks, carrots, sweet potatoes, cucumbers, pumpkins, melons and water-melons are considered to be fruit; ‘ginger’ means the edible root of the ginger plant in a fresh or preserved state. Ginger may be dried or preserved in syrup
(fruit) pulp the edible part of the whole fruit, if appropriate, less the peel, skin, seeds, pips and the like, which may have been sliced or crushed but which has not been reduced to a purée
(fruit) purée the edible part of the whole fruit, if necessary, less the peel, skin, seeds, pips and the like, which has been reduced to a purée by sieving or a similar process
aqueous extracts (of fruit) the aqueous extract of fruits which, subject to the losses necessarily occurring in proper manufacturing, contains all the water-soluble constituents of the fruit used
sugars authorised sugars are: the sugars as defined in Directive 2001/111/EC; fructose syrup; sugars extracted from fruit; brown sugar
cultural object means an object which is classified or defined by a Member State, before or after its unlawful removal from the territory of that Member State, as being among the ‘national treasures possessing artistic, historic or archaeological value’ under national legislation or administrative procedures within the meaning of Article 36 TFEU
unlawfully removed from the territory of a Member State means: (a) removed from the territory of a Member State in breach of its rules on the protection of national treasures or in breach of Regulation (EC) No 116/2009; or (b) not returned at the end of a period of lawful temporary removal or any breach of another condition governing such temporary removal
requesting Member State means the Member State from whose territory the cultural object has been unlawfully removed
requested Member State means the Member State in whose territory a cultural object, which was unlawfully removed from the territory of another Member State, is located
return means the physical return of the cultural object to the territory of the requesting Member State
possessor means the person physically holding the cultural object on his own account
holder means the person physically holding the cultural object for third parties
public collections means collections, defined as public in accordance with the legislation of a Member State, which are the property of that Member State, of a local or regional authority within that Member State or of an institution situated in the territory of that Member State, such institution being the property of, or significantly financed by, that Member State or local or regional authority
spirit drink means an alcoholic beverage: (a) intended for human consumption; (b) possessing particular organoleptic qualities; (c) having a minimum alcoholic strength of 15% vol.; (d) having been produced: (i) either directly: by the distillation, with or without added flavourings, of naturally fermented products, and/or by the maceration or similar processing of plant materials in ethyl alcohol of agricultural origin and/or distillates of agricultural origin, and/or spirit drinks within the meaning of this Regulation, and/or by the addition of flavourings, sugars or other sweetening products listed in Annex I(3) and/or other agricultural products and/or foodstuffs to ethyl alcohol of agricultural origin and/or to distillates of agricultural origin and/or to spirit drinks, within the meaning of this Regulation, (ii) or by the mixture of a spirit drink with one or more: other spirit drinks, and/or ethyl alcohol of agricultural origin or distillates of agricultural origin, and/or other alcoholic beverages, and/or drinks
ethyl alcohol of agricultural origin ethyl alcohol of agricultural origin possesses the following properties: (a) organoleptic characteristics: no detectable taste other than that of the raw material; (b) minimum alcoholic strength by volume: 96,0%; (c) maximum level of residues: (i) total acidity, expressed in grams of acetic acid per hectolitre of 100% vol. alcohol: 1,5, (ii) esters expressed in grams of ethyl acetate per hectolitre of 100% vol. alcohol: 1,3, (iii) aldehydes expressed in grams of acetaldehyde per hectolitre of 100% vol. alcohol: 0,5, (iv) higher alcohols expressed in grams of methyl2 propanol1 per hectolitre of 100% vol. alcohol: 0,5, (v) methanol expressed in grams per hectolitre of 100% vol. alcohol: 30, (vi) dry extract expressed in grams per hectolitre of 100% vol. alcohol: 1,5, (vii) volatile bases containing nitrogen expressed in grams of nitrogen per hectolitre of 100% vol. alcohol: 0,1, (viii) furfural: not detectable
distillate of agricultural origin distillate of agricultural origin means an alcoholic liquid which is obtained by the distillation, after alcoholic fermentation, of an agricultural product or products listed in Annex I to the Treaty which does not have the properties of ethyl alcohol or of a spirit drink but still retains the aroma and taste of the raw material(s) used. Where reference is made to the raw material used, the distillate must be obtained exclusively from that raw material
sweetening means using one or more of the following products in the preparation of spirit drinks: (a) semi-white sugar, white sugar, extra-white sugar, dextrose, fructose, glucose syrup, sugar solution, invert sugar solution, invert sugar syrup, as defined in Council Directive 2001/111/EC of 20 December 2001 relating to certain sugars intended for human consumption); (b) rectified concentrated grape must, concentrated grape must, fresh grape must; (c) burned sugar, which is the product obtained exclusively from the controlled heating of sucrose without bases, mineral acids or other chemical additives; (d) honey as defined in Council Directive 2001/110/EC of 20 December 2001 relating to honey; (e) carob syrup; (f) any other natural carbohydrate substances having a similar effect to those products
mixing means combining two or more different drinks to make a new drink
addition of alcohol means the addition of ethyl alcohol of agricultural origin and/or distillates of agricultural origin to a spirit drink
addition of water in the preparation of spirit drinks, the addition of water shall be authorised, provided that the quality of the water is in conformity with Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters ( 19 ) and Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, and that the water added does not change the nature of the product. This water may be distilled, demineralised, permuted or softened
blending means combining two or more spirit drinks of the same category, distinguished only by minor differences in composition due to one or more of the following factors: (a) the method of preparation; (b) the stills employed; (c) the period of maturation or ageing; (d) the geographical area of production. The spirit drink so produced shall be of the same category of spirit drink as the original spirit drinks before blending
maturation or ageing means allowing certain reactions to develop naturally in appropriate containers, thereby giving the spirit drink in question organoleptic qualities previously absent
flavouring means using in the preparation of a spirit drink one or more of the flavourings defined in Article 3(2)(a) of Regulation (EC) No 1334/2008
colouring means using in the preparation of a spirit drink one or more colorants, as defined in Directive 94/36/EC of the Europen Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs
alcoholic strength by volume means the ratio of the volume of pure alcohol present in the product in question at 20 °C to the total volume of that product at the same temperature
volatile substances content means the quantity of volatile substances other than ethyl alcohol and methanol contained in a spirit drink obtained exclusively by distillation, as a result solely of the distillation or redistillation of the raw materials used
place of manufacture means the place or region where the stage in the production process of the finished product which conferred on the spirit drink its character and essential definitive qualities took place
description means the terms used on the labelling, presentation and packaging; on the documents accompanying the transport of a drink; on the commercial documents, particularly the invoices and delivery notes; and in its advertising
presentation means the terms used on the labelling and on the packaging, including in advertising and sales promotion, in images or such like, as well as on the container, including the bottle and the closure
labelling means all descriptions and other references, signs, designs or trade marks which distinguish a drink and which appear on the same container, including its sealing device or the tag attached to the container and the sheathing covering the neck of the bottle
packaging means the protective wrappings, such as papers, envelopes of all kinds, cartons and cases, used in the transport and/or sale of one or more containers
rum (a) Rum is: (i) a spirit drink produced exclusively by alcoholic fermentation and distillation, either from molasses or syrup produced in the manufacture of cane sugar or from sugar-cane juice itself and distilled at less than 96% vol. so that the distillate has the discernible specific organoleptic characteristics of rum, or (ii) a spirit drink produced exclusively by alcoholic fermentation and distillation of sugar-cane juice which has the aromatic characteristics specific to rum and a volatile substances content equal to or exceeding 225 grams per hectolitre of 100% vol. alcohol. This spirit may be placed on the market with the word ‘agricultural’ qualifying the sales denomination ‘rum’ accompanied by any of the geographical indications of the French Overseas Departments and the Autonomous Region of Madeira as registered in Annex III.
(b) The minimum alcoholic strength by volume of rum shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Rum shall not be flavoured.
(e) Rum may only contain added caramel as a means to adapt colour.
(f) The word ‘traditionnel’ may supplement any of the geographical indications mentioned in category 1 of Annex III where the rum is produced by distillation at less than 90% vol., after alcoholic fermentation of alcohol-producing materials originating exclusively in the place of production considered. This rum must have a volatile substances content equal to or exceeding 225 grams per hectolitre of 100% vol. alcohol and must not be sweetened. The use of the word ‘traditionnel’ does not prevent the use of the terms ‘from sugar production’ or ‘agricultural’ which may be added to the sales denomination ‘rum’ and to geographical indications. This provision shall not affect the use of the word ‘traditionnel’ for all products not covered by this provision, according to their own specific criteria
whisky or whiskey (a) Whisky or whiskey is a spirit drink produced exclusively by: (i) distillation of a mash made from malted cereals with or without whole grains of other cereals, which has been: saccharified by the diastase of the malt contained therein, with or without other natural enzymes, fermented by the action of yeast; (ii) one or more distillations at less than 94,8% vol., so that the distillate has an aroma and taste derived from the raw materials used, (iii) maturation of the final distillate for at least three years in wooden casks not exceeding 700 litres capacity.
The final distillate, to which only water and plain caramel (for colouring) may be added, retains its colour, aroma and taste derived from the production process referred to in points (i), (ii) and (iii).
(b) The minimum alcoholic strength by volume of whisky or whiskey shall be 40%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Whisky or whiskey shall not be sweetened or flavoured, nor contain any additives other than plain caramel used for colouring.
grain spirit (a) Grain spirit is a spirit drink produced exclusively by the distillation of a fermented mash of whole grain cereals and having organoleptic characteristics derived from the raw materials used.
(b) With the exception of ‘Korn’, the minimum alcoholic strength by volume of grain spirit shall be 35%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Grain spirit shall not be flavoured.
(e) Grain spirit may only contain added caramel as a means to adapt colour.
(f) For a grain spirit to bear the sales denomination ‘grain brandy’, it must have been obtained by distillation at less than 95% vol. from a fermented mash of whole grain cereals, presenting organoleptic features deriving from the raw materials used
wine spirit (a) Wine spirit is a spirit drink: (i) produced exclusively by the distillation at less than 86% vol. of wine or wine fortified for distillation or by the redistillation of a wine distillate at less than 86% vol., (ii) containing a quantity of volatile substances equal to or exceeding 125 grams per hectolitre of 100% vol. alcohol, (iii) having a maximum methanol content of 200 grams per hectolitre of 100% vol. alcohol.
(b) The minimum alcoholic strength by volume of wine spirit shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Wine spirit shall not be flavoured. This shall not exclude traditional production methods.
(e) Wine spirit may only contain added caramel as a means to adapt colour.
(f) Where wine spirit has been matured, it may continue to be placed on the market as ‘wine spirit’ provided it has been matured for as long as, or longer than, the period stipulated for the spirit drink defined under category 5
brandy or Weinbrand (a) Brandy or Weinbrand is a spirit drink: (i) produced from wine spirit, whether or not wine distillate has been added, distilled at less than 94,8% vol., provided that that distillate does not exceed a maximum of 50% of the alcoholic content of the finished product, (ii) matured for at least one year in oak receptacles or for at least six months in oak casks with a capacity of less than 1000 litres, (iii) containing a quantity of volatile substances equal to or exceeding 125 grams per hectolitre of 100% vol. alcohol, and derived exclusively from the distillation or redistillation of the raw materials used, (iv) having a maximum methanol content of 200 grams per hectolitre of 100% vol. alcohol.
(b) The minimum alcoholic strength by volume of brandy or Weinbrand shall be 36%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Brandy or Weinbrand shall not be flavoured. This shall not exclude traditional production methods.
(e) Brandy or Weinbrand may only contain added caramel as a means to adapt colour
grape marc spirit or grape marc (a) Grape marc spirit or grape marc is a spirit drink which meets the following conditions: (i) it is produced exclusively from grape marc fermented and distilled either directly by water vapour or after water has been added; (ii) a quantity of lees may be added to the grape marc that does not exceed 25 kg of lees per 100 kg of grape marc used; (iii) the quantity of alcohol derived from the lees shall not exceed 35% of the total quantity of alcohol in the finished product; (iv) the distillation shall be carried out in the presence of the marc itself at less than 86% vol.; (v) redistillation at the same alcoholic strength is authorised; (vi) it contains a quantity of volatile substances equal to or exceeding 140 grams per hectolitre of 100% vol. alcohol and has a maximum methanol content of 1000 grams per hectolitre of 100% vol. alcohol.
(b) The minimum alcoholic strength by volume of grape marc spirit or grape marc shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Grape marc spirit or grape marc shall not be flavoured. This shall not exclude traditional production methods.
(e) Grape marc spirit or grape marc may only contain added caramel as a means to adapt colour.
fruit marc spirit (a) Fruit marc spirit is a spirit drink which meets the following conditions: (i) it is obtained exclusively by fermentation and distillation at less than 86% vol. of fruit marc except grape marc; (ii) it contains a minimum quantity of volatile substances of 200 grams per hectolitre of 100% vol. alcohol; (iii) the maximum methanol content shall be 1500 grams per hectolitre of 100% vol. alcohol; (iv) the maximum hydrocyanic acid content shall be 7 grams per hectolitre of 100% vol. alcohol in the case of stone-fruit marc spirit; (v) redistillation at the same alcoholic strength according to (i) is authorised.
(b) The minimum alcoholic strength by volume of fruit marc spirit shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Fruit marc spirit shall not be flavoured.
(e) Fruit marc spirit may only contain added caramel as a means to adapt colour.
(f) The sales denomination shall consist of the name of the fruit followed by ‘marc spirit’. If marcs of several different fruits are used, the sales denomination shall be ‘fruit marc spirit’
raisin spirit or raisin brandy (a) Raisin spirit or raisin brandy is a spirit drink produced exclusively by the distillation of the product obtained by the alcoholic fermentation of extract of dried grapes of the ‘Corinth Black’ or Moscatel of the Alexandria varieties, distilled at less than 94,5% vol., so that the distillate has an aroma and taste derived from the raw material used.
(b) The minimum alcoholic strength by volume of raisin spirit or raisin brandy shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Raisin spirit or raisin brandy shall not be flavoured.
(e) Raisin spirit or raisin brandy may only contain added caramel as a means to adapt colour
fruit spirit (a) Fruit spirit is a spirit drink: (i) produced exclusively by the alcoholic fermentation and distillation of fleshy fruit or must of such fruit, berries or vegetables, with or without stones, (ii) distilled at less than 86% vol. so that the distillate has an aroma and taste derived from the raw materials distilled, (iii) having a quantity of volatile substances equal to or exceeding 200 grams per hectolitre of 100% vol. alcohol, (iv) in the case of stone-fruit spirits, having a hydrocyanic acid content not exceeding 7 grams per hectolitre of 100% vol. alcohol.
(b) The maximum methanol content of fruit spirit shall be 1000 grams per hectolitre of 100% vol. alcohol. However for the following fruit spirits the maximum methanol content shall be: (i) 1200 grams per hectolitre of 100% vol. alcohol obtained from the following fruits or berries: plum (Prunus domestica L.), mirabelle (Prunus domestica L. subsp. syriaca (Borkh.) Janch. ex Mansf.), quetsch (Prunus domestica L.), apple (Malus domestica Borkh.), pear (Pyrus communis L.) except for Williams pears (Pyrus communis L. cv ‘Williams’), raspberries (Rubus idaeus L.), blackberries (Rubus fruticosus auct. aggr.), apricots (Prunus armeniaca L.), peaches (Prunus persica (L.) Batsch); (ii) 1350 grams per hectolitre of 100% vol. alcohol obtained from the following fruits or berries: Williams pears (Pyrus communis L. cv ‘Williams’), redcurrants (Ribes rubrum L.), blackcurrants (Ribes nigrum L.), rowanberries (Sorbus aucuparia L.), elderberries (Sambucus nigra L.), quinces (Cydonia oblonga Mill.), juniper berries (Juniperus communis L. and/or Juniperus oxicedrus L.).
(c) The minimum alcoholic strength by volume of fruit spirit shall be 37,5%.
(d) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(e) Fruit spirit shall not be flavoured.
(f) The sales denomination of fruit spirit shall be ‘spirit’ preceded by the name of the fruit, berry or vegetable, such as: cherry spirit or kirsch, plum spirit or slivovitz, mirabelle, peach, apple, pear, apricot, fig, citrus or grape spirit or other fruit spirits. It may also be called wasser, with the name of the fruit. The name of the fruit may replace ‘spirit’ preceded by the name of the fruit, solely in the case of the following fruits: mirabelle (Prunus domestica L. subsp. syriaca (Borkh.) Janch. ex Mansf.), plum (Prunus domestica L.), quetsch (Prunus domestica L.), fruit of arbutus (Arbutus unedo L.), ‘Golden Delicious’ apple. Should there be a risk that the final consumer does not easily understand one of these sales denominations, the labelling shall include the word ‘spirit’, possibly supplemented by an explanation.
(g) The name Williams may be used only to sell pear spirit produced solely from pears of the ‘Williams’ variety.
(h) Whenever two or more fruits, berries or vegetables are distilled together, the product shall be sold under the name ‘fruit spirit’ or ‘vegetable spirit’, as appropriate. The name may be supplemented by that of each fruit, berry or vegetable, in decreasing order of quantity used
cider spirit and perry spirit (a) Cider spirit and perry spirit are spirit drinks: (i) produced exclusively by the distillation at less than 86% vol. of cider or perry so that the distillate has an aroma and taste derived from the fruits, (ii) having a quantity of volatile substances equal to or exceeding 200 grams per hectolitre of 100% vol. alcohol, (iii) having a maximum methanol content of 1000 grams per hectolitre of 100% vol. alcohol.
(b) The minimum alcoholic strength by volume of cider spirit and of perry spirit shall be 37,5%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Neither cider spirit nor perry spirit shall be flavoured.
(e) Cider spirit and perry spirit may only contain added caramel as a means to adapt colour
honey spirit (a) Honey spirit is a spirit drink: (i) produced exclusively by fermentation and distillation of honey mash, (ii) distilled at less than 86% vol. so that the distillate has the organoleptic characteristics derived from the raw material used.
(b) The minimum alcoholic strength by volume of honey spirit shall be 35%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Honey spirit shall not be flavoured.
(e) Honey spirit may only contain added caramel as a means to adapt colour.
(f) Honey spirit may only be sweetened with honey
Hefebrand or lees spirit (a) Hefebrand or lees spirit is a spirit drink produced exclusively by the distillation at less than 86% vol. of lees of wine or of fermented fruit.
(b) The minimum alcoholic strength by volume of Hefebrand or lees spirit shall be 38%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Hefebrand or lees spirit shall not be flavoured.
(e) Hefebrand or lees spirit may only contain added caramel as a means to adapt colour.
(f) The sales denomination Hefebrand or lees spirit shall be supplemented by the name of the raw material used.
Bierbrand or eau de vie de bière (a) Bierbrand or eau de vie de bière is a spirit drink obtained exclusively by direct distillation under normal pressure of fresh beer with an alcoholic strength by volume of less than 86% such that the distillate obtained has organoleptic characteristics deriving from the beer.
(b) The minimum alcoholic strength by volume of Bierbrand or eau de vie de bière shall be 38%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Bierbrand or eau de vie de bière shall not be flavoured.
(e) Bierbrand or eau de vie de bière may only contain added caramel as a means to adapt colour
topinambur or Jerusalem artichoke spirit (a) Topinambur or Jerusalem artichoke spirit is a spirit drink produced exclusively by fermentation and distillation at less than 86% vol. of Jerusalem artichoke tubers (Helianthus tuberosus L.).
(b) The minimum alcoholic strength by volume of topinambur or Jerusalem artichoke spirit shall be 38%.
(c) No addition of alcohol as defined in Annex I(5), diluted or not, shall take place.
(d) Topinambur or Jerusalem artichoke spirit shall not be flavoured.
(e) Topinambur or Jerusalem artichoke spirit may only contain added caramel as a means to adapt colour
vodka (a) Vodka is a spirit drink produced from ethyl alcohol of agricultural origin obtained following fermentation with yeast from either: (i) potatoes and/or cereals, or (ii) other agricultural raw materials, distilled and/or rectified so that the organoleptic characteristics of the raw materials used and by-products formed in fermentation are selectively reduced. This process may be followed by redistillation and/or treatment with appropriate processing aids, including treatment with activated charcoal, to give it special organoleptic characteristics. Maximum levels of residue for ethyl alcohol of agricultural origin shall meet those laid down in Annex I, except that the methanol content shall not exceed 10 grams per hectolitre of 100% vol. alcohol.
(b) The minimum alcoholic strength by volume of vodka shall be 37,5%.
(c) The only flavourings which may be added are natural flavouring compounds present in distillate obtained from the fermented raw materials. In addition, the product may be given special organoleptic characteristics, other than a predominant flavour.
(d) The description, presentation or labelling of vodka not produced exclusively from the raw material(s) listed in paragraph (a)(i) shall bear the indication ‘produced from ...’, supplemented by the name of the raw material(s) used to produce the ethyl alcohol of agricultural origin. Labelling shall be in accordance with Article 13(2) of Directive 2000/13/EC
spirit (preceded by the name of the fruit) obtained by maceration and distillation (a) Spirit (preceded by the name of the fruit) obtained by maceration and distillation is a spirit drink: (i) produced by maceration of fruit or berries listed under point (ii), whether partially fermented or unfermented, with the possible addition of a maximum of 20 litres of ethyl alcohol of agricultural origin or spirit and/or distillate deriving from the same fruit per 100 kg of fermented fruit or berries, followed by distillation at less than 86% vol., (ii) obtained from the following fruits or berries: blackberry (Rubus fruticosus auct. aggr.), strawberry (Fragaria spp.), bilberry/blueberry (Vaccinium myrtillus L.), raspberry (Rubus idaeus L.), redcurrant (Ribes rubrum L.), white currant (Ribes niveum Lindl.), blackcurrant (Ribes nigrum L.), sloe (Prunus spinosa L.), rowanberry (Sorbus aucuparia L.), service-berry (Sorbus domestica L.), hollyberry (Ilex aquifolium and Ilex cassine L.), checkerberry (Sorbus torminalis (L.) Crantz), elderberry (Sambucus nigra L.), gooseberry (Ribes uva-crispa L. syn. Ribes grossularia), cranberry (Vaccinium L. subgenus Oxycoccus), lingonberry (Vaccinium vitis-idaea L.), high bush blueberry (Vaccinium corymbosum L.), sea-buckthorn (Hippophae rhamnoides L.), rosehip (Rosa canina L.), cloudberry (Rubus chamaemorus L.), crowberry (Empetrum nigrum L.), arctic bramble (Rubus arcticus L.), myrtle (Myrtus communis L.), banana (Musa spp.), passion fruit (Passiflora edulis Sims), ambarella (Spondias dulcis Sol. ex Parkinson), hog plum (Spondias mombin L.), walnut (Juglans regia L.), hazelnut (Corylus avellana L.), chestnut (Castanea sativa L.), citrus fruits (Citrus spp. L.), prickly pear (Opuntia ficus-indica).
(b) The minimum alcoholic strength by volume of a Spirit (preceded by the name of the fruit) obtained by maceration and distillation shall be 37,5%.
(c) Spirit (preceded by the name of the fruit) obtained by maceration and distillation shall not be flavoured.
(d) As regards the labelling and presentation of Spirit (preceded by the name of the fruit) obtained by maceration and distillation, the wording ‘obtained by maceration and distillation’ must appear on the description, presentation or labelling in characters of the same font, size and colour and in the same visual field as the wording ‘Spirit (preceded by the name of the fruit)’ and, in the case of bottles, on the front label
Geist (with the name of the fruit or the raw material used) (a) Geist (with the name of the fruit or the raw material used) is a spirit drink obtained by maceration of unfermented fruits and berries listed in category 16(a)(ii) or vegetables, nuts, or other plant materials such as herbs or rose petals in ethyl alcohol of agricultural origin, followed by distillation at less than 86% vol.
(b) The minimum alcoholic strength by volume of Geist (with the name of the fruit or the raw material used) shall be 37,5%.
(c) Geist (with the name of the fruit or the raw material used) shall not be flavoured
gentian (a) Gentian is a spirit drink produced from a distillate of gentian, itself obtained by the fermentation of gentian roots with or without the addition of ethyl alcohol of agricultural origin.
(b) The minimum alcoholic strength by volume of gentian shall be 37,5%.
(c) Gentian shall not be flavoured.
juniper-flavoured spirit drinks (a) Juniper-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin and/or grain spirit and/or grain distillate with juniper (Juniperus communis L. and/or Juniperus oxicedrus L.) berries.
(b) The minimum alcoholic strength by volume of juniper-flavoured spirit drinks shall be 30%.
(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation, and/or aromatic plants or parts of aromatic plants may be used in addition, but the organoleptic characteristics of juniper must be discernible, even if they are sometimes attenuated.
(d) Juniper-flavoured spirit drinks may bear the sales denominations Wacholder or genebra
gin (a) Gin is a juniper-flavoured spirit drink produced by flavouring organoleptically suitable ethyl alcohol of agricultural origin with juniper berries (Juniperus communis L.).
(b) The minimum alcoholic strength by volume of gin shall be 37,5%.
(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used for the production of gin so that the taste is predominantly that of juniper.
(d) The term ‘gin’ may be supplemented by the term ‘dry’ if it does not contain added sweetening exceeding 0,1 gram of sugars per litre of the final product
distilled gin (a) Distilled gin is: (i) a juniper-flavoured spirit drink produced exclusively by redistilling organoleptically suitable ethyl alcohol of agricultural origin of an appropriate quality with an initial alcoholic strength of at least 96% vol. in stills traditionally used for gin, in the presence of juniper berries (Juniperus communis L.) and of other natural botanicals provided that the juniper taste is predominant, or (ii) the mixture of the product of such distillation and ethyl alcohol of agricultural origin with the same composition, purity and alcoholic strength; flavouring substances and/or flavouring preparations as specified in category 20(c) may also be used to flavour distilled gin.
(b) The minimum alcoholic strength by volume of distilled gin shall be 37,5%.
(c) Gin obtained simply by adding essences or flavourings to ethyl alcohol of agricultural origin is not distilled gin.
(d) The term ‘distilled gin’ may be supplemented by the term ‘dry’ if it does not contain added sweetening exceeding 0,1 gram of sugars per litre of the final product
London gin (a) London gin is a type of distilled gin: (i) obtained exclusively from ethyl alcohol of agricultural origin, with a maximum methanol content of 5 grams per hectolitre of 100% vol. alcohol, whose flavour is introduced exclusively through the re-distillation in traditional stills of ethyl alcohol in the presence of all the natural plant materials used, (ii) the resultant distillate of which contains at least 70% alcohol by vol., (iii) where any further ethyl alcohol of agricultural origin is added it must be consistent with the characteristics listed in Annex I(1), but with a maximum methanol content of 5 grams per hectolitre of 100% vol. alcohol, (iv) which does not contain added sweetening exceeding 0,1 gram of sugars per litre of the final product nor colorants, (v) which does not contain any other added ingredients other than water.
(b) The minimum alcoholic strength by volume of London gin shall be 37,5%.
(c) The term London gin may be supplemented by the term ‘dry’
caraway-flavoured spirit drinks (a) Caraway-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin with caraway (Carum carvi L.).
(b) The minimum alcoholic strength by volume of caraway-flavoured spirit drinks shall be 30%.
(c) Other flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used but there must be a predominant taste of caraway
akvavit or aquavit (a) Akvavit or aquavit is a caraway-flavoured and/or dillseed-flavoured spirit drink produced by using ethyl alcohol of agricultural origin, flavoured with a distillate of plants or spices.
(b) The minimum alcoholic strength by volume of akvavit or aquavit shall be 37,5%.
(c) Other natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used, but the flavour of these drinks is largely attributable to distillates of caraway (Carum carvi L.) and/or dill (Anethum graveolens L.) seeds, the use of essential oils being prohibited.
(d) The bitter substances must not obviously dominate the taste; the dry extract content shall not exceed 1,5 grams per 100 millilitres
aniseed-flavoured spirit drinks (a) Aniseed-flavoured spirit drinks are spirit drinks produced by flavouring ethyl alcohol of agricultural origin with natural extracts of star anise (Illicium verum Hook f.), anise (Pimpinella anisum L.), fennel (Foeniculum vulgare Mill.), or any other plant which contains the same principal aromatic constituent, using one of the following processes or a combination thereof: (i) maceration and/or distillation, (ii) redistillation of the alcohol in the presence of the seeds or other parts of the plants specified above, (iii) addition of natural distilled extracts of aniseed-flavoured plants.
(b) The minimum alcoholic strength by volume of aniseed-flavoured spirit drinks shall be 15%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of aniseed-flavoured spirit drinks.
(d) Other natural plant extracts or aromatic seed may also be used, but the aniseed taste must remain predominant
pastis (a) Pastis is an aniseed-flavoured spirit drink which also contains natural extracts of liquorice root (Glycyrrhiza spp.), which implies the presence of the colorants known as ‘chalcones’ as well as glycyrrhizic acid, the minimum and maximum levels of which must be 0,05 and 0,5 grams per litre respectively.
(b) The minimum alcoholic strength by volume of pastis shall be 40%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of pastis.
(d) Pastis contains less than 100 grams of sugars per litre, expressed as invert sugar, and has a minimum and maximum anethole level of 1,5 and 2 grams per litre respectively
pastis de Marseille (a) Pastis de Marseille is a pastis with an anethole content of 2 grams per litre.
(b) The minimum alcoholic strength by volume of pastis de Marseille shall be 45%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of pastis de Marseille
anis (a) Anis is an aniseed-flavoured spirit drink whose characteristic flavour is derived exclusively from anise (Pimpinella anisum L.) and/or star anise (Illicium verum Hook f.) and/or fennel (Foeniculum vulgare Mill.).
(b) The minimum alcoholic strength by volume of anis shall be 35%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of anis
distilled anis (a) Distilled anis is anis which contains alcohol distilled in the presence of the seeds referred to in category 28(a), and in the case of geographical indications mastic and other aromatic seeds, plants or fruits, provided such alcohol constitutes at least 20% of the alcoholic strength of the distilled anis.
(b) The minimum alcoholic strength by volume of distilled anis shall be 35%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of distilled anis
bitter-tasting spirit drinks or bitter (a) Bitter-tasting spirit drinks or bitter are spirit drinks with a predominantly bitter taste produced by flavouring ethyl alcohol of agricultural origin with flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation.
(b) The minimum alcoholic strength by volume of bitter-tasting spirit drinks or bitter shall be 15%.
(c) Bitter tasting spirit drinks or bitter may also be sold under the names ‘amer’ or ‘bitter’ with or without another term
flavoured vodka (a) Flavoured vodka is vodka which has been given a predominant flavour other than that of the raw materials.
(b) The minimum alcoholic strength by volume of flavoured vodka shall be 37,5%.
(c) Flavoured vodka may be sweetened, blended, flavoured, matured or coloured.
(d) Flavoured vodka may also be sold under the name of any predominant flavour with the word ‘vodka’
liqueur (a) Liqueur is a spirit drink: (i) having a minimum sugar content, expressed as invert sugar, of: 70 grams per litre for cherry liqueurs the ethyl alcohol of which consists exclusively of cherry spirit, 80 grams per litre for gentian or similar liqueurs prepared with gentian or similar plants as the sole aromatic substance, 100 grams per litre in all other cases; (ii) produced using ethyl alcohol of agricultural origin or a distillate of agricultural origin or one or more spirit drinks or a mixture thereof, which has been sweetened and to which one or more flavourings, products of agricultural origin or foodstuffs have been added.
(b) The minimum alcoholic strength by volume of liqueur shall be 15%.
(c) Flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation may be used in the preparation of liqueur. However, only natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation shall be used in the preparation of the following liqueurs: (i) Fruit liqueurs: blackcurrant, cherry, raspberry, mulberry, bilberry, citrus fruit, cloudberry, arctic bramble, cranberry, lingonberry, sea buckthorn, pineapple; (ii) plant liqueurs: mint, gentian, aniseed, génépi, vulnerary.
(d) The following compound terms may be used in the presentation of liqueurs produced in the Community where ethyl alcohol of agricultural origin is used to mirror established production methods: prune brandy, orange brandy, apricot brandy, cherry brandy, solbaerrom, also called blackcurrant rum.
Crème de (followed by the name of a fruit or the raw material used) (a) Spirit drinks known as Crème de (followed by the name of a fruit or the raw material used), excluding milk products, are liqueurs with a minimum sugar content of 250 grams per litre expressed as invert sugar.
(b) The minimum alcoholic strength by volume of Crème de (followed by the name of a fruit or the raw material used) shall be 15%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to this spirit drink.
(d) The sales denomination may be supplemented by the term ‘liqueur’
crème de cassis (a) Crème de cassis is a blackcurrant liqueur with a minimum sugar content of 400 grams per litre expressed as invert sugar.
(b) The minimum alcoholic strength by volume of crème de cassis shall be 15%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to crème de cassis.
(d) The sales denomination may be supplemented by the term ‘liqueur’
guignolet (a) Guignolet is a liqueur obtained by maceration of cherries in ethyl alcohol of agricultural origin.
(b) The minimum alcoholic strength by volume of guignolet shall be 15%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to guignolet.
(d) The sales denomination may be supplemented by the term ‘liqueur’
punch au rhum (a) Punch au rhum is a liqueur for which the alcohol content is provided exclusively by rum.
(b) The minimum alcoholic strength by volume of punch au rhum shall be 15%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to punch au rhum.
(d) The sales denomination may be supplemented by the term ‘liqueur’
sloe gin (a) Sloe gin is a liqueur produced by maceration of sloes in gin with the possible addition of sloe juice.
(b) The minimum alcoholic strength by volume of sloe gin shall be 25%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of sloe gin.
(d) The sales denomination may be supplemented by the term ‘liqueur’
sloe-aromatised spirit drink or Pacharán Sloe-aromatised spirit drink or Pacharán is a spirit drink:
(a) which has a predominant sloe taste and is obtained by the maceration of sloes (Prunus spinosa) in ethyl alcohol of agricultural origin, with the addition of natural extracts of anise and/or distillates of anise;
(b) which has a minimum alcoholic strength by volume of 25%;
(c) for the production of which a minimum quantity of 125 grams of sloe fruits per litre of final product has been used;
(d) which has sugar content, expressed as invert sugar between 80 and 250 grams per litre of the final product;
(e) the organoleptic characteristics, colour and taste of which are provided exclusively by the fruit used and the anise.
The term ‘Pacharán’ may be used as a sales denomination only when the product is manufactured in Spain. When the product is manufactured outside Spain, ‘Pacharán’ may only be used to supplement the sales denomination ‘Sloe-aromatised spirit drink’, provided that it is accompanied by the words: ‘produced in …’, followed by the name of the Member State or third country of the manufacture.
sambuca (a) Sambuca is a colourless aniseed-flavoured liqueur: (i) containing distillates of anise (Pimpinella anisum L.), star anise (Illicium verum L.) or other aromatic herbs, (ii) with a minimum sugar content of 350 grams per litre expressed as invert sugar, (iii) with a natural anethole content of not less than 1 gram and not more than 2 grams per litre.
(b) The minimum alcoholic strength by volume of sambuca shall be 38%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 apply to sambuca.
(d) The sales denomination may be supplemented by the term ‘liqueur’
maraschino, marrasquino or maraskino (a) Maraschino, marrasquino or maraskino is a colourless liqueur the flavour of which is given mainly by a distillate of marasca cherries or of the product obtained by macerating cherries or parts of cherries in alcohol of agricultural origin with a minimum sugar content of 250 grams per litre expressed as invert sugar.
(b) The minimum alcoholic strength by volume of maraschino, marrasquino or maraskino shall be 24%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to maraschino, marrasquino or maraskino.
(d) The sales denomination may be supplemented by the term ‘liqueur’
nocino (a) Nocino is a liqueur the flavour of which is given mainly by maceration and/or distillation of whole green walnuts (Juglans regia L.) with a minimum sugar content of 100 grams per litre expressed as invert sugar.
(b) The minimum alcoholic strength by volume of nocino shall be 30%.
(c) The rules on flavouring substances and flavouring preparations for liqueurs laid down under category 32 shall apply to nocino.
(d) The sales denomination may be supplemented by the term ‘liqueur’
egg liqueur or advocaat or avocat or advokat (a) Egg liqueur or advocaat or avocat or advokat is a spirit drink, whether or not flavoured, obtained from ethyl alcohol of agricultural origin, distillate and/or spirit, the ingredients of which are quality egg yolk, egg white and sugar or honey. The minimum sugar or honey content must be 150 grams per litre expressed as invert sugar. The minimum content of pure egg yolk must be 140 grams per litre of the final product.
(b) By way of derogation from Article 2(1)(c), the minimum alcoholic strength by volume of egg liqueur or advocaat or avocat or advokat shall be 14%.
(c) Only flavouring substances as defined in Article 3(2)(b) of Regulation (EC) No 1334/2008 and flavouring preparations as defined in Article 3(2)(d) of that Regulation may be used in the preparation of egg liqueur or advocaat or avocat or advokat
liqueur with egg (a) Liqueur with egg is a spirit drink, whether or not flavoured, obtained from ethyl alcohol of agricultural origin, distillate and/or spirit, the characteristic ingredients of which are quality egg yolk, egg white and sugar or honey. The minimum sugar or honey content must be 150 grams per litre expressed as invert sugar. The minimum egg yolk content must be 70 grams per litre of the final product.
(b) The minimum alcoholic strength by volume of liqueur with egg shall be 15%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of liqueur with egg
mistrà (a) Mistrà is a colourless spirit drink flavoured with aniseed or natural anethole: (i) with an anethole content of not less than 1 gram and not more than 2 grams per litre, (ii) that may also contain a distillate of aromatic herbs, (iii) containing no added sugar.
(b) The minimum alcoholic strength by volume of mistrà shall be 40% and the maximum alcoholic strength by volume shall be 47%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of mistrà
väkevä glögi or spritglögg (a) Väkevä glögi or spritglögg is a spirit drink produced by flavouring ethyl alcohol of agricultural origin with flavour of cloves and/or cinnamon using one of the following processes: maceration and/or distillation, redistillation of the alcohol in the presence of parts of the plants specified above, addition of natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No 1334/2008 of cloves or cinnamon or a combination of these methods.
(b) The minimum alcoholic strength by volume of väkevä glögi or spritglögg shall be 15%.
(c) Other flavourings, flavouring substances and/or flavouring preparations as defined in Article 3(2)(b), (d) and (h) of Regulation (EC) No 1334/2008 may also be used, but the flavour of the specified spices must be predominant.
(d) The content of wine or wine products shall not exceed 50% of the final product.
Berenburg or Beerenburg (a) Berenburg or Beerenburg is a spirit drink: (i) produced using ethyl alcohol of agricultural origin, (ii) with the maceration of fruit or plants or parts thereof, (iii) containing as specific flavour distillate of gentian root (Gentiana lutea L.), of juniper berries (Juniperus communis L.) and of laurel leaves (Laurus nobilis L.), (iv) varying in colour from light to dark brown, (v) which may be sweetened to a maximum of 20 grams per litre expressed as invert sugar.
(b) The minimum alcoholic strength by volume of Berenburg or Beerenburg shall be 30%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of Berenburg or Beerenburg
honey or mead nectar (a) Honey or mead nectar is a spirit drink produced by flavouring the mixture of fermented honey mash and honey distillate and/or ethyl alcohol of agricultural origin, which contains at least 30% vol. of fermented honey mash.
(b) The minimum alcoholic strength by volume of honey or mead nectar shall be 22%.
(c) Only natural flavouring substances and flavouring preparations as defined in Article 1(2)(b)(i) and Article 1(2)(c) of Directive 88/388/EEC may be used in the preparation of honey or mead nectar provided that the honey taste is predominant.
(d) Honey or mead nectar may be sweetened only with honey
Rum-Verschnitt is produced in Germany and obtained by mixing rum and alcohol, whereby a minimum proportion of 5% of the alcohol contained in the final product must come from rum. The minimum alcoholic strength by volume of Rum-Verschnitt shall be 37,5%. As regards the labelling and presentation of the product Rum-Verschnitt the word Verschnitt must appear on the description, presentation and labelling in characters of the same font, size and colour as, and on the same line as, the word ‘Rum’ and, in the case of bottles, on the front label. Where this product is sold outside the German market, its alcoholic composition must appear on the label
slivovice is produced in the Czech Republic and obtained by the addition to the plum distillate, before the final distillation, of a maximum proportion of 30% by volume of ethyl alcohol of agricultural origin. This product must be described as ‘spirit drink’ and may also use the name slivovice in the same visual field on the front label. If this Czech slivovice is placed on the market in the Community, its alcoholic composition must appear on the label. This provision is without prejudice to the use of the name slivovice for fruit spirits according to category 9
personal protective equipment (PPE) means: (a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety; (b) interchangeable components for equipment referred to in point (a) which are essential for its protective function; (c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use
making available on the market means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of PPE on the Union market
manufacturer means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places PPE from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
technical specification means a document that prescribes technical requirements to be fulfilled by PPE
harmonised standard means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of PPE that has already been made available to the end-user
withdrawal means any measure aimed at preventing PPE in the supply chain from being made available on the market
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
CE marking means a marking by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
marketing shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration. Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing the supply of seed to official testing and inspection bodies, the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied. The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall no be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the certification authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided. The conditions for the application of this provision shall be determined in accordance with the procedure referred to in Article 28(2)
beet means sugar and fodder beet of the species Beta vulgaris L.
basic seed means seed (i) which has been produced under the responsibility of the breeder according to well-defined practices for the maintenance of the variety; (ii) which is intended for the production of seed of the category ‘certified seed’; (iii) which, subject to the provisions of Article 5, satisfies the conditions laid down in Annex I for basic seed; and (iv) which has been found by official examination or, in the case of the conditions laid down in Annex IB, either by official examination or examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed means seed (i) which is of direct descent from basic seed; (ii) which is intended for the production of beet; (iii) which, subject to the provisions of point (b) of Article 5, satisfies the conditions laid down in Annex I for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
monogerm seed means genetically monogerm seed
precision seed means seed designed for use in precision drills which, as required under Annex I, part B(3)(b)(bb) and (cc), gives single seedlings
official measures means measures taken (i) by State authorities; or (ii) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or (iii) in the case of ancillary activities which are also under State control, by any natural person duly sworn for that purpose; provided that the persons mentioned under (ii) and (iii) derive no private gain from such measures
small EC packages means packages containing the following certified seeds: (i) monogerm or precision seed: not exceeding 100 000 clusters or grains or a net weight of 2,5 kg excluding, where appropriate, granulated pesticides, pelleting substances or other solid additives; (ii) seed other than monogerm or precision seed: not exceeding a net weight of 10 kg, excluding, where appropriate, granulated pesticides, pelleting substances or other solid additives
cereals plants of the following species intended for agricultural or horticultural production other than production for ornamental purposes: Avena nuda L. -- Small naked oat, Hulless oat; Avena sativa L. (includes A. byzantina K. Koch) -- Oats and Red oat; Avena strigosa Schreb. -- Black oat, Bristle oat; Hordeum vulgare L. -- Barley; Oryza sativa L. -- Rice; Phalaris canariensis L. -- Canary grass; Secale cereale L. -- Rye; Sorghum bicolor (L.) Moench -- Sorghum; Sorghum sudanense (Piper) Stapf -- Sudan grass; xTriticosecale Wittm. ex A. Camus -- hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale; Triticum aestivum L. -- Wheat; Triticum durum Desf. -- Durum wheat; Triticum spelta L. -- Spelt wheat; Zea mays L. (partim) -- Maize except popcorn and sweet corn. This definition shall also cover the following hybrids resulting from the crossing of species referred to above: Sorghum bicolor (L.) Moench × Sorghum sudanense (Piper) Stapf. -- Hybrids resulting from the crossing of Sorghum bicolor and Sorghum sudanense. Unless otherwise specified, seed of the aforementioned hybrids shall be subject to the standards or other conditions applicable to seed of each of the species from which they are derived.
varieties, hybrids and inbred lines of maize and Sorghum spp. (a) Open-pollinated variety: a sufficiently uniform and stable variety; (b) Inbred line: a sufficiently uniform and stable line, obtained either by artificial self-fertilization accompanied by selection over several successive generations or by equivalent operations; (c) Simple hybrid: the first generation of a cross, defined by the breeder, between two inbred lines; (d) Double hybrid: the first generation of a cross, defined by the breeder, between two simple hybrids; (e) Triple-cross hybrid: the first generation of a cross, defined by the breeder, between an inbred line and a simple hybrid; (f) Top Cross hybrid: the first generation of a cross, defined by the breeder, between an inbred line or a simple hybrid and an open-pollinated variety; (g) Intervarietal hybrid: the first generation of a cross, defined by the breeder, between plants grown from basic seed of two open-pollinated varieties
basic seed (oats, barley, rice, canary grass, rye triticale, wheat, durum wheat and spelt wheat, other than hybrids in each case) seed (a) which has been produced under the responsibility of the breeder according to accepted practices for the maintenance of the variety; (b) which is intended for the production of seed either of the category ‘certified seed’ or of the categories ‘certified seed, first generation’ or ‘certified seed, second generation’; (c) which, subject to the provisions of Article 4 (1) (a), satisfies the conditions laid down in Annexes I and II for basic seed; and (d) which has been found by official examination or in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c)
basic seed (hybrids of oats, barley, rice, rye, wheat, durum wheat, spelt wheat and self-pollinating triticale) (a) which is intended for the production of hybrids; (b) which, subject to the provisions of Article 4, satisfies the conditions laid down in Annexes I and II for basic seed; and (c) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a) and (b)
basic seed maize Sorghum spp. 1. Basic seed of open-pollinated varieties: seed (a) which has been produced under the responsibility of the breeder according to accepted practices for the maintenance of the variety; (b) which is intended for the production of seed of this variety of the category ‘certified seed’ or of Top Cross hybrids or of intervarietal hybrids; (c) which, subject to the provisions of Article 4, satisfies the conditions laid down in Annexes I and II for basic seed; and (d) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c);
2. Basic seed of inbred lines: seed (a) which, subject to the provisions of Article 4, satisfies the conditions laid down in Annexes I and II for basic seed; and (b) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a);
3. Basic seed of simple hybrids: seed (a) which is intended for the production of double hybrids, triple-cross hybrids or Top Cross hybrids; (b) which, subject to the provisions of Article 4, satisfies the conditions laid down in Annexes I and II for basic seed; and (c) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a) and (b).
certified seed (canary grass, other than hybrids, rye, sorghum, sudan grass, maize and hybrids of oats, barley, rice, wheat, durum wheat, spelt wheat and self pollinating triticale) seed (a) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (b) which is intended for purposes other than the production of cereal seed; (c) which, subject to the provisions of Article 4 (1) (b) and (2), satisfies the conditions laid down in Annexes I and II for certified seed; and (d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c)
certified seed of the first generation (oats, barley, rice, triticale, wheat, durum wheat and spelt wheat, other than hybrids in each case) seed (a) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (b) which is intended either for the production of seed of the category ‘certified seed, second generation’ or for purposes other than the production of cereal seed; (c) which satisfies the conditions laid down in Annexes I and II for certified seed of the first generation; and (d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c)
certified seed of the second generation (oats, barley, rice, triticale, wheat, durum wheat and spelt wheat, other than hybrids in each case) seed (a) which has been produced directly from basic seed, from certified seed of the first generation or, if the breeder so requests, from seed of a generation prior to basic seed which has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (b) which is intended for purposes other than the production of cereal seed; (c) which satisfies the conditions laid down in Annexes I and II for certified seed of the second generation; and (d) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (a), (b) and (c)
official measures measures taken (a) by State authorities, or (b) by any legal person whether governed by public or by private law, acting under the responsibility of the State, or (c) in the case of ancillary activities which are also subject to State control, by any natural person duly sworn for that purpose, provided that the persons mentioned under (b) and (c) derive no private gain from such measures
marketing means the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration. Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing: the supply of seed to official testing and inspection bodies; the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied. The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the certification authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided. The conditions for the application of this provision shall be determined in accordance with the procedure referred to in Article 25(2)
oil and fibre plants means plants of the following genera and species: Arachis hypogaea L. -- Groundnut (peanut); Brassica juncea (L.) Czern -- Brown mustard; Brassica napus L. (partim) -- Swede rape; Brassica nigra (L.) W.D.J. Koch -- Black mustard; Brassica rapa L. var. silvestris (Lam.) Briggs -- Turnip rape; Cannabis sativa L. -- Hemp; Carthamus tinctorius L. -- Safflower; Carum carvi L. -- Caraway; Glycine max (L.) Merr. -- Soja bean; Gossypium spp. -- Cotton; Helianthus annuus L. -- Sunflower; Linum usitatissimum L. -- Flax, linseed; Papaver somniferum L. — Poppy -- Opium poppy; Sinapis alba L. -- White mustard
basic seed (varieties other than hybrids) means seed (i) which has been produced under the responsibility of the breeder according to accepted practices for the maintenance of the variety; (ii) which is intended for the production of seed either of the category ‘certified seed’ or of the categories ‘certified seed, first generation’ or ‘certified seed, second generation’ or, where appropriate, ‘certified seed, third generation’; (iii) which, subject to the provisions of Article 5, satisfies the conditions laid down in Annexes I and II for basic seed; and (iv) which has been found by official examination or in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
basic seed (hybrids) 1. ‘Basic seed of inbred lines’ means seed (i) which, subject to the provisions of Article 5, satisfies the conditions laid down in Annexes I and II for basic seed; and (ii) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i);
2. ‘Basic seed of simple hybrids’ means seed (i) which is intended for the production of three-way-cross hybrids or double-cross hybrids; (ii) which, subject to the provisions of Article 5, satisfies the conditions laid down in Annexes I and II for basic seed; and (iii) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i) and (ii)
certified seed (turnip rape, brown mustard, swede rape, dioecious hemp, safflower, black mustard, caraway, sunflower, opium poppy, white mustard) means seed (i) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed and which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (ii) which is intended for purposes other than the production of seed of oil or fibre plants; (iii) which, subject to the provisions of point (b) of Article 5, satisfies the conditions laid down in Annexes I and II for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed, first generation (groundnut, monoecious hemp, flax, linseed, soya, cotton) means seed (i) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (ii) which is intended either for the production of seed of the category ‘certified seed, second generation’ or, where appropriate, of the category ‘certified seed, third generation’, or for purposes other than the production of seed of oil or fibre plants; (iii) which satisfies the conditions laid down in Annexes I and II for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed, second generation (groundnut, flax, linseed, soya, cotton) means seed (i) which has been produced directly from basic seed, from certified seed of the first generation or, if the breeder so requests, from seed of a generation prior to basic seed and which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (ii) which is intended for purposes other than the production of seed of oil or fibre plants or, where appropriate, which is intended for the production of seed of the category ‘certified seed, third generation’; (iii) which satisfies the conditions laid down in Annexes I and II for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed, second generation (monoecius hemp) means seed (i) which has been produced directly from certified seed of the first generation which has been established and officially controlled with a special view to the production of certified seed of the second generation; (ii) which is intended for the production of hemp to be harvested in flower; (iii) which satisfies the conditions laid down in Annexes I and II for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed, third generation (flax, linseed) means seed (i) which is of direct descent from basic seed, from certified seed of the first or second generation or, if the breeder so requests, from seed of a generation prior to basic seed and which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed; (ii) which is intended for purposes other than the production of seed of oil or fibre plants; (iii) which satisfies the conditions laid down in Annexes I and II for certified seed; and (iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
commercial seed means seed (i) which is identifiable as belonging to a species; (ii) which, subject to the provisions of Article 5(b), satisfies the conditions laid down in Annex II for commercial seed, and (iii) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i) and (ii)
official measures means measures taken (i) by State authorities; or (ii) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or (iii) in the case of ancillary activities which are also subject to State control, by any natural person duly sworn for that purpose, provided that the persons mentioned under (ii) and (iii) derive no private gain from such measures
ad hoc aid means aid not awarded on the basis of an aid scheme
aid means any measure fulfilling the criteria laid down in Article 107(1) of the Treaty
aid intensity means the gross aid amount expressed as a percentage of the eligible costs, before any deduction of tax or other charge. Where aid is awarded in a form other than a grant, the aid amount is the grant equivalent of the aid. Aid payable in several instalments is discounted to its value at the date of award. The interest rate to be used for this purpose is the discount rate (13) applicable at the date of award. The aid intensity is calculated per beneficiary
aid scheme means any act on the basis of which, without further Implementing measures being required, individual aid may be awarded to undertakings defined therein in a general and abstract manner and any act on the basis of which aid which is not linked to a specific project may be awarded to one or several undertakings
applied research means industrial research, experimental development, or any combination of both
arm’s length means that the conditions of the transaction between the contracting parties do not differ from those which would be stipulated between independent enterprises and contain no element of collusion. Any transaction that results from an open, transparent and non-discriminatory procedure is considered as meeting the arm’s length principle
date of award of the aid means the date on which the legal right to receive the aid is conferred on the beneficiary under the applicable national legal regime
effective collaboration means collaboration between at least two independent parties to exchange knowledge or technology, or to achieve a common objective based on the division of labour where the parties jointly define the scope of the collaborative project, contribute to its implementation and share its risks, as well as its results. One or several parties may bear the full costs of the project and thus relieve other parties of its financial risks. Contract research and provision of research services are not considered forms of collaboration
exclusive development means the public procurement of research and development services of which all benefits accrue exclusively to the contracting authority or contracting entity, and which it may use in the conduct of its own affairs on condition that it fully remunerates them
experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services. Experimental development may comprise prototyping, demonstrating, piloting, testing and validation of new or improved products, processes or services in environments representative of real life operating conditions where the primary objective is to make further technical improvements on products, processes or services that are not substantially set. This may include the development of a commercially usable prototype or pilot which is necessarily the final commercial product and which is too expensive to produce for it to be used only for demonstration and validation purposes. Experimental development does not include routine or periodic changes made to existing products, production lines, manufacturing processes, services and other operations in progress, even if those changes may represent improvements
feasibility study means the evaluation and analysis of the potential of a project, which aims at supporting the process of Decision making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success
full allocation means that the research organisation, research infrastructure or public purchaser enjoys the full economic benefit of intellectual property rights by retaining the right to make unrestricted use of them, particularly the right of ownership and the right to license. This may also be the case where the research organisation or research infrastructure (respectively, public purchaser) decides to conclude further contracts concerning those rights, including licensing them to a collaboration partner (respectively, undertakings)
fundamental research means experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any direct commercial application or use in view
gross grant equivalent means the amount of the aid if it had been awarded in the form of a grant, before any deduction of tax or other charge
highly qualified personnel means staff having a tertiary education degree and at least five years of relevant professional experience which may also include doctoral training
individual aid means aid awarded to a specific undertaking and includes ad hoc aid and aid awarded on the basis of an aid scheme
industrial research means the planned research or critical investigation aimed at the acquisition of new knowledge and skills for developing new products, processes or services or for bringing about a significant improvement in existing products, processes or services. It comprises the creation of components parts of complex systems, and may include the construction of prototypes in a laboratory environment or in an environment with simulated interfaces to existing systems as well as of pilot lines, when necessary for the industrial research and notably for generic technology validation
innovation advisory services means consultancy, assistance and training in the fields of knowledge transfer, acquisition, protection and exploitation of intangible assets, use of standards and Regulations embedding them
innovation clusters means structures or organised groups of independent parties (such as innovative start-ups, small, medium and large enterprises, as well as research and knowledge dissemination organisations, non-for-profit organisations and other related economic actors) designed to stimulate innovative activity by promoting sharing of facilities and exchange of knowledge and expertise and by contributing effectively to knowledge transfer, networking, information dissemination and collaboration among the undertakings and other organisations in the cluster
innovation support services means the provision of office space, data banks, libraries, market research, laboratories, quality labelling, testing and certification for the purpose of developing more effective products, processes or services
intangible assets means assets that do not have a physical or financial embodiment such as patents, licences, know-how or other intellectual property
knowledge transfer means any process which has the aim of acquiring, collecting and sharing explicit and tacit knowledge, including skills and competence in both economic and non-economic activities such as research collaborations, consultancy, licensing, spin-off creation, publication and mobility of researchers and other personnel involved in those activities. Besides scientific and technological knowledge, it includes other kinds of knowledge such as knowledge on the use of standards and Regulations embedding them and on conditions of real life operating environments and methods for organisational innovation, as well as management of knowledge related to identifying, acquiring, protecting, defending and exploiting intangible assets
large enterprises means undertakings which do not fall within the definition of small and medium-sized enterprises
net extra costs means the difference between the expected net present values of the aided project or activity and a viable counterfactual investment that the beneficiary would have carried out in the absence of aid
organisational innovation means the implementation of a new organisational method in an undertaking’s business practices, workplace organisation or external relations, excluding changes that are based on organisational methods already in use in the undertaking, changes in management strategy, mergers and acquisitions, ceasing to use a process, simple capital replacement or extension, changes resulting purely from changes in factor prices, customisation, localisation, regular, seasonal and other cyclical changes and trading of new or significantly improved products
personnel costs means the cost of researchers, technicians and other supporting staff to the extent employed on the relevant project or activity
pre-commercial procurement means the public procurement of research and development services where the contracting authority or contracting entity does not reserve all the results and benefits of the contract exclusively for itself for use in the conduct of its own affairs, but shares them with the providers under market conditions. The contract, the object of which falls within one or several categories of research and development defined in this framework, must be of limited duration and may include the development of prototypes or limited volumes of first products or services in the form of a test series. The purchase of commercial volumes of products or services must not be an object of the same contract
process innovation means the implementation of a new or significantly improved production or delivery method (including significant changes in techniques, equipment or software), excluding minor changes or improvements, increases in production or service capabilities through the addition of manufacturing or logistical systems which are very similar to those already in use, ceasing to use a process, simple capital replacement or extension, changes resulting purely from changes in factor prices, customisation, localisation, regular, seasonal and other cyclical changes and trading of new or significantly improved products
R&D project means an operation that includes activities spanning over one or several categories of research and development defined in this framework, and that is intended to accomplish an indivisible task of a precise economic, scientific or technical nature with clearly pre-defined goals. A R&D project may consist of several work packages, activities or services, and includes clear objectives, activities to be carried out to achieve those objectives (including their expected costs), and concrete deliverables to identify the outcomes of those activities and compare them with the relevant objectives. When two or more R&D projects are not clearly separable from each other and in particular when they do not have independent probabilities of technological success, they are considered as a single project
repayable advance means a loan for a project which is paid in one or more instalments and the conditions for the reimbursement of which depend on the outcome of the project
research and knowledge dissemination organisation or research organisation means an entity (such as universities or research institutes, technology transfer agencies, innovation intermediaries, research-oriented physical or virtual collaborative entities), irrespective of its legal status (organised under public or private law) or way of financing, whose primary goal is to independently conduct fundamental research, industrial research or experimental development or to widely disseminate the results of such activities by way of teaching, publication or knowledge transfer. Where such entity also pursues economic activities, the financing, the costs and the revenues of those economic activities must be accounted for separately. Undertakings that can exert a decisive influence upon such an entity, for example in the quality of shareholders or members, may not enjoy a preferential access to the results generated by it
research infrastructure means facilities, resources and related services that are used by the scientific community to conduct research in their respective fields and covers scientific equipment or set of instruments, knowledge-based resources such as collections, archives or structured scientific information, enabling information and communication technology-based infrastructures such as grid, computing, software and communication, or any other entity of a unique nature essential to conduct research. Such infrastructures may be ‘single-sited’ or ‘distributed’ (an organised network of resources)
secondment means temporary employment of staff by a beneficiary with the right for the staff to return to the previous employer
small and medium-sized enterprises or SMEs, small enterprises and medium-sized enterprises means undertakings fulfilling the criteria laid down in the Commission Recommendation on the definition of micro, small and medium-sized enterprises
start of works or start of the project means either the start of R&D&I activities, or the first agreement between the beneficiary and the contractors to conduct the project, whichever comes first. Preparatory works such as obtaining permits and conducting feasibility studies are not considered as start of works
tangible assets means assets consisting of land, buildings and plants, machinery and equipment
cableway installation means a whole on-site system, consisting of infrastructure and subsystems, which is designed, constructed, assembled and put into service with the objective of transporting persons, where the traction is provided by cables positioned along the line of travel
subsystem means a system listed in Annex I, or a combination thereof, intended to be incorporated into a cableway installation
infrastructure means a station structure or a structure along the line specifically designed for each cableway installation and constructed on-site, which takes into account the layout and the data of the system and which is needed for the construction and the operation of the cableway installation, including the foundations
safety component means any component of equipment or any device intended to be incorporated into a subsystem or a cableway installation for the purpose of ensuring a safety function, the failure of which endangers the safety or health of passengers, operating personnel or third parties
operability means all the technical provisions and measures which have an impact on design and construction and are necessary in order for the cableway installation to operate safely
maintainability means all the technical provisions and measures which have an impact on design and construction and are necessary for maintenance, having been designed to ensure that the cableway installation operates safely
cable car means a cableway installation where the carriers are suspended from and propelled by one or more cables
drag lift means a cableway installation where passengers with appropriate equipment are towed along a prepared track
funicular railway means a cableway installation in which the carriers are hauled by one or more ropes along a track that may lie on the ground or be supported by fixed structures
making available on the market means any supply of a subsystem or a safety component for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a subsystem or a safety component on the Union market
entry into service means the initial operation of a cableway installation with the explicit object of transporting persons
manufacturer means any natural or legal person who manufactures a subsystem or a safety component or who has such a subsystem or a safety component designed or manufactured, and markets that subsystem or safety component under his name or trade mark or incorporates it into a cableway installation
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places a subsystem or a safety component from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a subsystem or a safety component available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor of a subsystem or a safety component
technical specification means a document that prescribes technical requirements to be fulfilled by a cableway installation, infrastructure, subsystem or safety component
harmonised standard means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the essential requirements of this Regulation relating to a subsystem or safety component have been fulfilled
conformity assessment body means a body that performs conformity assessment activities relating to a subsystem or safety component, including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of a subsystem or a safety component that has already been made available to the person responsible for the cableway installation
withdrawal means any measure aimed at preventing a subsystem or a safety component in the supply chain from being made available on the market
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
CE marking means a marking by which the manufacturer indicates that the subsystem or the safety component is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
IMI means the electronic tool provided by the Commission to facilitate administrative cooperation between competent authorities of the Member States and between competent authorities of the Member States and the Commission
administrative cooperation means the working in collaboration of competent authorities of the Member States or competent authorities of the Member States and the Commission, by exchanging and processing information, including through notifications and alerts, or by providing mutual assistance, including for the resolution of problems, for the purpose of better application of Union law
internal market area means a legislative or functional field of the internal market, within the meaning of Article 26(2) TFEU, in which IMI is used in accordance with Article 3 of this Regulation
administrative cooperation procedure means a pre-defined workflow provided for in IMI allowing IMI actors to communicate and interact with each other in a structured manner
IMI coordinator means a body appointed by a Member State to perform support tasks necessary for the efficient functioning of IMI in accordance with this Regulation
competent authority means any body established at either national, regional or local level and registered in IMI with specific responsibilities relating to the application of national law or Union acts listed in the Annex in one or more internal market areas
IMI actors means the competent authorities, IMI coordinators and the Commission
IMI user means a natural person working under the authority of an IMI actor and registered in IMI on behalf of that IMI actor
external actors means natural or legal persons other than IMI users that may interact with IMI only through separate technical means and in accordance with a specific pre-defined workflow provided for that purpose
blocking means applying technical means by which personal data become inaccessible to IMI users via the normal interface of IMI
formal closure means applying the technical facility provided by IMI to close an administrative cooperation procedure
occupation of carrier of goods by waterway vessel means the activities engaged in by any natural person or any undertaking carrying goods by inland waterway for hire or reward, even if this occupation is not exercised on a regular basis
undertaking means companies or firms within the meaning of Article 58 of the Treaty and groups or cooperatives of operators whose purpose is to obtain business from shipping agents for distribution among their members, irrespective of whether such groups or cooperatives possess legal personality
craft means a vessel or item of floating equipment
vessel means an inland waterway vessel or seagoing ship
inland waterway vessel means a vessel intended solely or mainly for navigation on inland waterways
tug means a vessel specially built to perform towing operations
pusher means a vessel specially built to propel a pushed convoy
passenger vessel means a day trip or cabin vessel constructed and equipped to carry more than 12 passengers
floating equipment means a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators
floating establishment means any floating installation not normally intended to be moved, such as a swimming bath, dock, jetty or boathouse
floating object means a raft or other structure, object or assembly capable of navigation, not being a vessel or floating equipment or establishment
recreational craft means a vessel other than a passenger vessel, intended for sport or pleasure
high-speed vessel means a motorised craft capable of reaching speeds over 40 km/h in relation to water
water displacement means the immersed volume of the vessel, in cubic metres
length (L) means the maximum length of the hull in metres, excluding rudder and bowsprit
breadth (B) means the maximum breadth of the hull in metres, measured to the outer edge of the shell plating (excluding paddle wheels, rub rails, and similar)
draught (T) means the vertical distance in metres between the lowest point of the hull without taking into account the keel or other fixed attachments and the maximum draught line
linked inland waterways means waterways of a Member State connected, by inland waterways which can be navigated under national or international law by craft falling within the scope of this Directive, to inland waterways of another Member State
river information services (RIS) means the harmonised information services to support traffic and transport management in inland navigation, including, wherever technically feasible, interfaces with other transport modes. RIS do not deal with internal commercial activities between one or more of the involved companies, but are open for interfacing with commercial activities. RIS comprise services such as fairway information, traffic information, traffic management, calamity abatement support, information for transport management, statistics and customs services and waterway charges and port dues
fairway information means geographical, hydrological, and administrative information regarding the waterway (fairway). Fairway Information is one-way information: shore to ship or shore to office
tactical traffic information means the information affecting immediate navigation Decisions in the actual traffic situation and the close geographic surroundings
strategic traffic information means the information affecting the medium and long-term Decisions of RIS users
RIS application means the provision of river information services through dedicated systems
RIS centre means the place where the services are managed by operators
RIS users means all different user groups including boat masters, RIS operators, lock and/or bridge operators, waterway authorities, port and terminal operators, operators in calamity centres of emergency services, fleet managers, cargo shippers and freight brokers
interoperability means that services, data contents, data exchange formats and frequencies are harmonised in such a way that RIS users have access to the same services and information on a European level
port means any specified area of land and water, with boundaries defined by the Member State in which the port is situated, containing works and equipment designed to facilitate commercial maritime transport operations
ship/port interface means the interactions that occur when a ship is directly and immediately affected by actions involving the movement of persons or goods or the provision of port services to or from the ship
port facility means a location where the ship/port interface takes place; this includes areas such as anchorages, waiting berths and approaches from seaward, as appropriate
focal point for port security means the body designated by each Member State to serve as contact point for the Commission and other Member States and to facilitate, follow up and provide information on the application of the port security measures laid down in this Directive
port security authority means the authority responsible for security matters in a given port
anti-fouling system means a coating, paint, surface treatment, surface, or device that is used on a ship to control or prevent attachment of unwanted organisms
gross tonnage means the gross tonnage calculated in accordance with the tonnage measurement Regulations contained in Annex 1 to the International Convention on Tonnage Measurement of Ships, 1969, or any successor Convention
length means the length as defined in the International Convention on Load Lines, 1966, as modified by the Protocol of 1988 relating thereto, or any successor Convention
ship means a vessel of any type whatsoever operating in the marine environment and includes hydrofoil boats, air-cushion vehicles, submersibles, floating craft, fixed or floating platforms, floating storage units (FSUs) and floating production storage and off-loading units (FPSOs)
AFS-Convention means the International Convention on the control of harmful anti-fouling systems on ships, adopted on 5 October 2001, irrespective of its entry into force
recognised organisation means a body recognised in accordance with the provisions of Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations
AFS-Certificate means the certificate issued to ships in conformity with the provisions of Annex 4 to the AFS-Convention or, during the interim period, a certificate issued in accordance with the format laid down in Annex II to this Regulation, when it is issued by the administration of any Member State or by a recognised organisation acting on its behalf
AFS-Declaration means a declaration drawn up under the provisions of Annex 4 to the AFS-Convention or, during the interim period, a declaration signed by the owner or the owner's authorised agent and drawn up in accordance with the format laid down in Annex III to this Regulation
European AFS-Statement of Compliance means a document recording compliance with Annex 1 to the AFS-Convention, issued by a recognised organisation on behalf of the administration of a Member State
interim period means the period beginning on 1 July 2003 and ending on the date of entry into force of the AFS-Convention
MARPOL 73/78 means the International Convention for the Prevention of Pollution from Ships, 1973, as amended by the Protocol of 1978 relating thereto, in their up-to-date versions
oil tanker means an oil tanker as defined in Regulation 1.5 of Annex I to MARPOL 73/78
deadweight means deadweight as defined in Regulation 1.23 of Annex I to MARPOL 73/78
Category 1 oil tanker means an oil tanker of 20 000 tonnes deadweight or above and carrying crude oil, fuel oil, heavy diesel oil or lubricating oil as cargo or of 30 000 tonnes deadweight or above and carrying oil other than the above and which does not comply with the requirements in Regulations 18.1 to 18.9, 18.12 to 18.15, 30.4, 33.1, 33.2, 33.3, 35.1, 35.2 and 35.3 of Annex I to MARPOL 73/78
Category 2 oil tanker means an oil tanker of 20 000 tonnes deadweight or above and carrying crude oil, fuel oil, heavy diesel oil or lubricating oil as cargo or of 30 000 tonnes deadweight or above and carrying oil other than the above and which complies with the requirements in Regulations 18.1 to 18.9, 18.12 to 18.15, 30.4, 33.1, 33.2, 33.3, 35.1, 35.2 and 35.3 of Annex I to MARPOL 73/78 and is fitted with segregated ballast tanks protectively located (SBT/PL)
Category 3 oil tanker means an oil tanker of 5 000 tonnes deadweight or above but less than that specified in points (4) and (5)
single-hull oil tanker means an oil tanker which does not comply with the double-hull or equivalent design requirements in Regulations 19 and 28.6 of Annex I to MARPOL 73/78
double-hull oil tanker means an oil tanker: (a) of 5 000 tonnes deadweight or above, complying with the double-hull or equivalent design requirements in Regulations 19 and 28.6 of Annex I to MARPOL 73/78 or with the requirements in Regulation 20.1.3 thereof; or (b) of 600 tonnes deadweight or above but less than 5 000 tonnes deadweight, fitted with double-bottom tanks or spaces complying with Regulation 19.6.1 of Annex I to MARPOL 73/78 and wing tanks or spaces arranged in accordance with Regulation 19.3.1 thereof and complying with the requirement as to distance w in Regulation 19.6.2 thereof
age means the age of the ship, expressed in number of years from its date of delivery
heavy diesel oil means diesel oil as defined in Regulation 20 of Annex I to MARPOL 73/78
fuel oil means heavy distillates of crude oil or residues therefrom or blends of such materials as defined in Regulation 20 of Annex I to MARPOL 73/78
heavy grade oil means: (a) crude oils of a density at 15 °C of over 900 kg/m3 (corresponding to an API grade of less than 25,7); (b) oils other than crude oils and of a density at 15 °C of over 900 kg/m3 or a kinematic viscosity at 50 °C of over 180 mm2/s (corresponding to a kinematic viscosity of over 180 cSt); (c) bitumen and tar and emulsions thereof
collective investment undertaking means an AIF as defined in point (a) of Article 4(1) of Directive 2011/61/EU
qualifying venture capital fund means a collective investment undertaking that: (i) intends to invest at least 70% of its aggregate capital contributions and uncalled committed capital in assets that are qualifying investments, calculated on the basis of amounts investible after deduction of all relevant costs and holdings in cash and cash equivalents, within a time frame laid down in its rules or instruments of incorporation; (ii) does not use more than 30% of its aggregate capital contributions and uncalled committed capital for the acquisition of assets other than qualifying investments, calculated on the basis of amounts investible after deduction of all relevant costs and holdings in cash and cash equivalents; (iii) is established within the territory of a Member State
manager of a qualifying venture capital fund means a legal person the regular business of which is managing at least one qualifying venture capital fund
qualifying portfolio undertaking means an undertaking that: (i) at the time of an investment by the qualifying venture capital fund is not admitted to trading on a regulated market or on a multilateral trading facility (MTF) as defined in points (14) and (15) of Article 4(1) of Directive 2004/39/EC, employs fewer than 250 persons, and has an annual turnover not exceeding EUR 50 million or an annual balance sheet total not exceeding EUR 43 million; (ii) is not itself a collective investment undertaking; (iii) is not one or more of the following: a credit institution as defined in point (1) of Article 4 of Directive 2006/48/EC of the Europen Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions, an investment firm as defined in point (1) of Article 4(1) of Directive 2004/39/EC, an insurance undertaking as defined in point (1) of Article 13 of Directive 2009/138/EC of the Europen Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II), a financial holding company as defined in point (19) of Article 4 of Directive 2006/48/EC, or a mixed-activity holding company as defined in point (20) of Article 4 of Directive 2006/48/EC; (iv) is established within the territory of a Member State, or in a third country provided that the third country: is not listed as a Non-Cooperative Country and Territory by the Financial Action Task Force on Anti-Money Laundering and Terrorist Financing, has signed an agreement with the home Member State of the manager of a qualifying venture capital fund and with each other Member State in which the units or shares of the qualifying venture capital fund are intended to be marketed to ensure that the third country fully complies with the standards laid down in Article 26 of the OECD Model Tax Convention on Income and on Capital and ensures an effective exchange of information in tax matters, including any multilateral tax agreements
qualifying investments means any of the following instruments: (i) equity or quasi-equity instruments that are issued by: a qualifying portfolio undertaking and acquired directly by the qualifying venture capital fund from the qualifying portfolio undertaking, a qualifying portfolio undertaking in exchange for an equity security issued by the qualifying portfolio undertaking, or an undertaking of which the qualifying portfolio undertaking is a majority-owned subsidiary and which is acquired by the qualifying venture capital fund in exchange for an equity instrument issued by the qualifying portfolio undertaking; (ii) secured or unsecured loans granted by the qualifying venture capital fund to a qualifying portfolio undertaking in which the qualifying venture capital fund already holds qualifying investments, provided that no more than 30% of the aggregate capital contributions and uncalled committed capital in the qualifying venture capital fund is used for such loans; (iii) shares of a qualifying portfolio undertaking acquired from existing shareholders of that undertaking; (iv) units or shares of one or several other qualifying venture capital funds, provided that those qualifying venture capital funds have not themselves invested more than 10% of their aggregate capital contributions and uncalled committed capital in qualifying venture capital funds
relevant costs means all fees, charges and expenses which are directly or indirectly borne by investors and which are agreed between the manager of a qualifying venture capital fund and the investors therein
equity means ownership interest in an undertaking, represented by the shares or other forms of participation in the capital of the qualifying portfolio undertaking, issued to its investors
quasi-equity means any type of financing instrument which is a combination of equity and debt, where the return on the instrument is linked to the profit or loss of the qualifying portfolio undertaking and where the repayment of the instrument in the event of default is not fully secured
marketing means a direct or indirect offering or placement at the initiative of the manager of a qualifying venture capital fund, or on its behalf, of units or shares of a venture capital fund it manages to or with investors domiciled or with a registered office in the Union
committed capital means any commitment pursuant to which an investor is obliged, within the time frame laid down in the rules or instruments of incorporation of the qualifying venture capital fund, to acquire an interest in, or to make capital contributions to, that fund
home Member State means the Member State where the manager of a qualifying venture capital fund is established and is subject to registration with the competent authorities in accordance with point (a) of Article 3(3) of Directive 2011/61/EU
host Member State means the Member State, other than the home Member State, where the manager of a qualifying venture capital fund markets qualifying venture capital funds in accordance with this Regulation
competent authority means the national authority which the home Member State designates, by law or Regulation, to undertake the registration of managers of collective investment undertakings falling within the scope of this Regulation
24 GHz range radio spectrum band means the 24,15 +/– 2,50 GHz frequency band
automotive short-range radar equipment means equipment providing road vehicle-based radar functions for collision mitigation and traffic safety applications
automotive short-range radar equipment put into service in the Community means automotive short-range radar equipment originally installed or replacing one so installed in a vehicle which will be or which has been registered, placed on the market or put into service in the Community
on non-interference and non-protected basis means that no harmful interference may be caused to other users of the band and that no claim may be made for protection from harmful interference received from other systems or services operating in that band
reference dates means 30 June 2013 for the frequency between 21,65 and 24,25 GHz and 1 January 2018 for the frequency between 24,25 and 26,65 GHz
transition date means 30 June 2007
vehicle means any vehicle as defined by Article 2 of Directive 70/156/EEC
deactivation means the termination of emissions by automotive short-range radar equipment
exclusion zone means the area around a radio astronomy station defined by a radius equivalent to a specific distance from the station
duty cycle means the ratio of time during any one-hour period when equipment is actively transmitting
cocoa butter designates the fat obtained from cocoa beans or parts of cocoa beans with the following characteristics: free fatty acid content (expressed as oleic acid): not more than 1,75%; unsaponifiable matter (determined using petroleum ether): not more than 0,5%, except in the case of press cocoa butter, where it shall not be more than 0,35%
cocoa powder, cocoa designate the product obtained by converting into powder cocoa beans which have been cleaned, shelled and roasted, and which contains not less than 20% cocoa butter, calculated according to the weight of the dry matter, and not more than 9% water
fat-reduced cocoa, fat-reduced cocoa powder designate cocoa powder containing less than 20% cocoa butter, calculated according to the weight of the dry matter
powdered chocolate, chocolate in powder designate the product consisting of a mixture of cocoa powder and sugars, containing not less than 32% cocoa powder
drinking chocolate, sweetened cocoa, sweetened cocoa powder designate the product consisting of a mixture of cocoa powder and sugars, containing not less than 25% cocoa powder; these names shall be accompanied by the term ‘fat-reduced’ in the case where the product is fat-reduced as defined at (b)
chocolate (a) designates the product obtained from cocoa products and sugars which, subject to (b), contains not less than 35% total dry cocoa solids, including not less than 18% cocoa butter and not less than 14% of dry non-fat cocoa solids;
(b) however, where this name is supplemented by the words: ‘vermicelli’ or ‘flakes’: the product presented in the form of granules or flakes must contain not less than 32% total dry cocoa solids, including not less than 12% cocoa butter and not less than 14% of dry non-fat cocoa solids; ‘couverture’: the product must contain not less than 35% total dry cocoa solids, including not less than 31% cocoa butter and not less than 2,5% of dry non-fat cocoa solids; ‘Gianduja’ (or one of the derivatives of the word ‘gianduja’) nut chocolate: the product must be obtained firstly from chocolate having a minimum total dry cocoa solids content of 32% including a minimum dry non-fat cocoa solids content of 8%, and secondly from finely ground hazelnuts in such quantities that 100 g of the product contain not less than 20 g and not more than 40 g of hazelnuts. The following may be added: (a) milk and/or dry milk solids obtained by evaporation, in such proportion that the finished product does not contain more than 5% dry milk solids; (b) almonds, hazelnuts and other nut varieties, either whole or broken, in such quantities that, together with the ground hazelnuts, they do not exceed 60% of the total weight of the product
milk chocolate (a) designates the product obtained from cocoa products, sugars and milk or milk products, which, subject to (b) contains: not less than 25% total dry cocoa solids, not less than 14% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, not less than 2,5% dry non-fat cocoa solids, not less than 3,5% milk fat, not less than 25% total fat (cocoa butter and milk fat). (b) However, where this name is supplemented by the words: ‘vermicelli’ or ‘flakes’: the product presented in the form of granules or flakes must contain not less than 20% total dry cocoa solids, not less than 12% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, and not less than 12% total fat (cocoa butter and milk fat), ‘couverture’: the product must have a minimum total fat (cocoa butter and milk fat) content of 31%, ‘Gianduja’ (or one of the derivatives of the word ‘gianduja’) nut milk chocolate: the product must be obtained firstly from milk chocolate having a minimum content of 10% of dry milk solids, obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream or from partly or wholly dehydrated cream, butter or milk fat and secondly from finely ground hazelnuts, in such quantities that 100 g of the product contain not less than 15 g and not more than 40 g of hazelnuts. Almonds, hazelnuts and other nut varieties may also be added, either whole or broken, in such quantities that, together with the ground hazelnuts, they do not exceed 60% of the total weight of the product. (c) Where in this name the word ‘milk’ is replaced by: ‘cream’: the product must have a minimum milk fat content of 5,5%, ‘skimmed milk’: the product must have a milk fat content not greater than 1%. (d) The United Kingdom, Ireland and Malta may authorise the use in their territory of the term ‘milk chocolate’ to designate the product referred to in point 5, on condition that the term is accompanied in all three cases by an indication of the amount of dry milk solids laid down for each of the products, in the form ‘milk solids: …% minimum.’
family milk chocolate designates the product obtained from cocoa products, sugars and milk or milk products and which contains: not less than 20% total dry cocoa solids, not less than 20% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, not less than 2,5% dry non-fat cocoa solids, not less than 5% milk fat, not less than 25% total fat (cocoa butter and milk fat)
white chocolate designates the product obtained from cocoa butter, milk or milk products and sugars which contains not less than 20% cocoa butter and not less than 14% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, of which not less than 3,5% is milk fat
filled chocolate, chocolate with … filling, chocolate with … centre designate the filled product, the outer part of which consists of one of the products defined in 3, 4, 5 and 6. The designations do not apply to products, the inside of which consists of bakery products, pastry, biscuit or edible ice. The outer chocolate portion of products bearing one of these names shall constitute not less than 25% of the total weight of the product.
chocolate a la taza designates the product obtained from cocoa products, sugars, and flour or starch from wheat, rice or maize, which contains not less than 35% total dry cocoa solids, including not less than 18% cocoa butter and not less than 14% dry non-fat cocoa solids, and not more than 8% flour or starch
chocolate familiar a la taza designates the product obtained from cocoa products, sugars, and flour or starch from wheat, rice or maize, which contains not less than 30% total dry cocoa solids, including not less than 18% cocoa butter and not less than 12% dry non-fat cocoa solids, and not more than 18% flour or starch
a chocolate or a praline designates the product in single-mouthful size, consisting of: filled chocolate, or a single chocolate or a combination or a mixture of chocolate within the meaning of the definitions given in 3, 4, 5 or 6 and other edible substances, provided that chocolate constitutes not less than 25% of the total weight of the product
making available on the market shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market shall mean the first making available of a product on the Community market
manufacturer shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark
authorised representative shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer shall mean any natural or legal person established within the Community who places a product from a third country on the Community market
distributor shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
economic operators shall mean the manufacturer, the authorised representative, the importer and the distributor
technical specification shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service
harmonised standard shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive
accreditation shall have the meaning assigned to it by Regulation (EC) No 765/2008
national accreditation body shall have the meaning assigned to it by Regulation (EC) No 765/2008
conformity assessment shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled
conformity assessment body shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall shall mean any measure aimed at achieving the return of a product that has already been made available to the end user
withdrawal shall mean any measure aimed at preventing a product in the supply chain from being made available on the market
CE marking shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing
Community harmonisation legislation shall mean any Community legislation harmonising the conditions for the marketing of products
transportable pressure equipment means: (a) all pressure receptacles, their valves and other accessories when appropriate, as covered in Chapter 6.2 of the Annexes to Directive 2008/68/EC; (b) tanks, battery vehicles/wagons, multiple-element gas containers (MEGCs), their valves and other accessories when appropriate, as covered in Chapter 6.8 of the Annexes to Directive 2008/68/EC; when the equipment under (a) or (b) is used in accordance with those Annexes for the transport of Class 2 gases, excluding gases or articles with figures 6 and 7 in the classification code, and for the transport of the dangerous substances of other classes specified in Annex I to this Directive. Transportable pressure equipment shall be understood as including gas cartridges (UN No 2037) and excluding aerosols (UN No 1950), open cryogenic receptacles, gas cylinders for breathing apparatus, fire extinguishers (UN No 1044), transportable pressure equipment exempted according to 1.1.3.2 of the Annexes to Directive 2008/68/EC and transportable pressure equipment exempted from the rules for construction and testing of packaging according to special provisions in 3.3 of the Annexes to Directive 2008/68/EC
Annexes to Directive 2008/68/EC means Section I.1 of Annex I, Section II.1 of Annex II, and Section III.1 of Annex III to Directive 2008/68/EC
placing on the market means the first making available of transportable pressure equipment on the Union market
making available on the market means any supply of transportable pressure equipment for distribution or use on the Union market in the course of a commercial or public service activity, whether in return for payment or free of charge
use means filling, temporary storage linked to carriage, emptying and refilling of transportable pressure equipment
withdrawal means any measure aimed at preventing transportable pressure equipment from being made available on the market or from being used
recall means any measure aimed at achieving the return of transportable pressure equipment that has already been made available to the end user
manufacturer means any natural or legal person who manufactures transportable pressure equipment, or parts thereof, or who has such equipment designed or manufactured and markets it under his name or trademark
authorised representative means any natural or legal person established within the Union who has received a written mandate from the manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union, who places transportable pressure equipment or parts thereof from a third country on the Union market
distributor means any natural or legal person established within the Union, other than the manufacturer or the importer, who makes transportable pressure equipment or parts thereof available on the market
owner means any natural or legal person established within the Union who owns transportable pressure equipment
operator means any natural or legal person established in the Union using transportable pressure equipment
economic operator means the manufacturer, the authorised representative, the importer, the distributor, the owner or the operator acting in the course of a commercial or public service activity, whether in return for payment or free of charge
conformity assessment means the assessment and the procedure for the assessment of conformity set out in the Annexes to Directive 2008/68/EC
Pi marking means a marking which indicates that the transportable pressure equipment is in conformity with the applicable conformity assessment requirements set out in the Annexes to Directive 2008/68/EC and in this Directive
reassessment of conformity means the procedure undertaken, at the request of the owner or operator, for the subsequent assessment of the conformity of transportable pressure equipment manufactured and placed on the market before the date of implementation of Directive 1999/36/EC
periodic inspection means the periodic inspection and the procedures governing the periodic inspection as set out in the Annexes to Directive 2008/68/EC
intermediate inspection means the intermediate inspection and the procedures governing the intermediate inspection as set out in the Annexes to Directive 2008/68/EC
exceptional check means the exceptional check and the procedures governing the exceptional check set out in the Annexes to Directive 2008/68/EC
national accreditation body means the sole body in a Member State that performs accreditation with authority derived from the State
accreditation means an attestation by a national accreditation body that a notified body meets the requirements set out in the second paragraph of 1.8.6.8 of the Annexes to Directive 2008/68/EC
notifying authority means the authority designated by a Member State pursuant to Article 17
notified body means an inspection body meeting the requirements set out in the Annexes to Directive 2008/68/EC and the conditions set out in Articles 20 and 26 of this Directive and notified in accordance with Article 22 of this Directive
notification is the process of awarding notified body status to an inspection body and includes communication of this information to the Commission and to the Member States
market surveillance means the activities carried out and measures taken by public authorities to ensure that transportable pressure equipment during its life cycle complies with the requirements set out in Directive 2008/68/EC and this Directive and does not endanger health, safety or any other aspect of public interest protection
appliances means appliances burning gaseous fuels used for cooking, refrigeration, air-conditioning, space heating, hot water production, lighting or washing, and also forced draught burners and heating bodies to be equipped with such burners
fittings means safety devices, controlling devices or regulating devices and sub-assemblies thereof, designed to be incorporated into an appliance or to be assembled to constitute an appliance
burning means a process in which gaseous fuel reacts with oxygen producing heat or light
washing means the entire washing process, including drying and ironing
cooking means the art or practice of preparing or warming food for consumption with the use of heat and employing a wide range of methods
gaseous fuel means any fuel which is in a gaseous state at a temperature of 15 °C under an absolute pressure of 1 bar
industrial process means the extraction, growth, refining, processing, production, manufacture or preparation of materials, plants, livestock, animal products, food or other products with a view to their commercial use
industrial premises means any place where the main activity carried out is an industrial process that would be subject to specific national health and safety Regulations
gas family means a group of gaseous fuels with similar burning behaviour linked together by a range of Wobbe indices
gas group means a specified range of Wobbe indices within that of the gas family concerned
Wobbe index means an indicator of the interchangeability of fuel gases used to compare the combustion energy output of different composition fuel gases in an appliance
appliance category means the identification of gas families and/or gas groups that an appliance is designed to burn safely and at the desired performance level, as indicated by the appliance category marking
energy efficiency means the ratio of output of performance of an appliance to input of energy
making available on the market means any supply of an appliance or a fitting for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of an appliance or a fitting on the Union market
putting into service means the first use of an appliance in the Union by its end-user
manufacturer means any natural or legal person who manufactures an appliance or a fitting or who has an appliance or a fitting designed or manufactured, and markets that appliance or fitting under his name or trademark or uses the appliance for his own purposes
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places an appliance or a fitting from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an appliance or a fitting available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
technical specification means a document that prescribes technical requirements to be fulfilled by an appliance or a fitting
harmonised standard means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the essential requirements of this Regulation relating to an appliance or a fitting have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of an appliance that has already been made available to the end-user or of a fitting that has already been made available to an appliance manufacturer
withdrawal means any measure aimed at preventing an appliance or a fitting in the supply chain from being made available on the market
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
CE marking means a marking by which the manufacturer indicates that the appliance or the fitting is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
consumer means a consumer as defined in point (a) of Article 3 of Directive 2008/48/EC
creditor means a natural or legal person who grants or promises to grant credit falling within the scope of Article 3 in the course of his trade, business or profession
credit agreement means an agreement whereby a creditor grants or promises to grant, to a consumer, a credit falling within the scope of Article 3 in the form of a deferred payment, loan or other similar financial accommodation
ancillary service means a service offered to the consumer in conjunction with the credit agreement
credit intermediary means a natural or legal person who is not acting as a creditor or notary and not merely introducing, either directly or indirectly, a consumer to a creditor or credit intermediary, and who, in the course of his trade, business or profession, for remuneration, which may take a pecuniary form or any other agreed form of financial consideration: (a) presents or offers credit agreements to consumers; (b) assists consumers by undertaking preparatory work or other pre-contractual administration in respect of credit agreements other than as referred to in point (a); or (c) concludes credit agreements with consumers on behalf of the creditor
group means a group of creditors which are to be consolidated for the purposes of drawing up consolidated accounts, as defined in Directive 2013/34/EU of the Europen Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings
tied credit intermediary means any credit intermediary who acts on behalf of and under the full and unconditional responsibility of: (a) only one creditor; (b) only one group; or (c) a number of creditors or groups which does not represent the majority of the market
appointed representative means a natural or legal person who performs activities referred to in point 5 that is acting on behalf of and under the full and unconditional responsibility of only one credit intermediary
credit institution means credit institution as defined in point 1 of Article 4(1) of Regulation (EU) No 575/2013
non-credit institution means any creditor that is not a credit institution
staff means: (a) any natural person working for the creditor, or credit intermediary who is directly engaged in the activities covered by this Directive or who has contacts with consumers in the course of activities covered by this Directive; (b) any natural person working for an appointed representative who has contacts with consumers in the course of activities covered by this Directive; (c) any natural person directly managing or supervising the natural persons referred to in points (a) and (b)
total amount of credit means the total amount of credit as defined in point (l) of Article 3 of Directive 2008/48/EC
total cost of the credit to the consumer means the total cost of the credit to the consumer as defined in point (g) of Article 3 of Directive 2008/48/EC including the cost of valuation of property where such valuation is necessary to obtain the credit but excluding registration fees for the transfer of ownership of the immovable property. It excludes any charges payable by the consumer for non-compliance with the commitments laid down in the credit agreement
total amount payable by the consumer means the total amount payable by the consumer as defined in point (h) of Article 3 of Directive 2008/48/EC
annual percentage rate of charge (APRC) means the total cost of the credit to the consumer, expressed as an annual percentage of the total amount of credit, where applicable, including the costs referred to in Article 17(2) and equates, on an annual basis, to the present value of all future or existing commitments (drawdowns, repayments and charges) agreed by the creditor and the consumer
borrowing rate means the borrowing rate as defined in point (j) of Article 3 of Directive 2008/48/EC
creditworthiness assessment means the evaluation of the prospect for the debt obligation resulting from the credit agreement to be met
durable medium means durable medium as defined in point (m) of Article 3 of Directive 2008/48/EC
home Member State means: (a) where the creditor or credit intermediary is a natural person, the Member State in which his head office is situated; (b) where the creditor or credit intermediary is a legal person, the Member State in which its registered office is situated or, if under its national law it has no registered office, the Member State in which its head office is situated
host Member State means the Member State, other than the home Member State, in which the creditor or credit intermediary has a branch or provides services
advisory services means the provision of personal recommendations to a consumer in respect of one or more transactions relating to credit agreements and constitutes a separate activity from the granting of a credit and from the credit intermediation activities set out in point 5
competent authority means an authority designated as competent by a Member State in accordance with Article 5
bridging loan means a credit agreement either of no fixed duration or which is due to be repaid within 12 months, used by the consumer as a temporary financing solution while transitioning to another financial arrangement for the immovable property
contingent liability or guarantee means a credit agreement which acts as a guarantee to another separate but ancillary transaction, and where the capital secured against an immovable property is only drawn down if an event or events specified in the contract occur
shared equity credit agreement means a credit agreement where the capital repayable is based on a contractually set percentage of the value of the immovable property at the time of the capital repayment or repayments
tying practice means the offering or the selling of a credit agreement in a package with other distinct financial products or services where the credit agreement is not made available to the consumer separately
bundling practice means the offering or the selling of a credit agreement in a package with other distinct financial products or services where the credit agreement is also made available to the consumer separately but not necessarily on the same terms or conditions as when offered bundled with the ancillary services
foreign currency loan means a credit agreement where the credit is: (a) denominated in a currency other than that in which the consumer receives the income or holds the assets from which the credit is to be repaid; or (b) denominated in a currency other than that of the Member State in which the consumer is resident
insurance-led financial conglomerate means a financial conglomerate the most important financial sector of which is insurance, in accordance with Article 3(2) of Directive 2002/87/EC
banking-led or investment-led financial conglomerate means a financial conglomerate the most important financial sector of which is either the banking sector or the investment services sector, in accordance with Article 3(2) of Directive 2002/87/EC
personal data means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person
processing means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction
restriction of processing means the marking of stored personal data with the aim of limiting their processing in the future
profiling means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements
pseudonymisation means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person
filing system means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis
controller means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law
processor means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller
recipient means a natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not. However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing
third party means a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data
consent of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her
personal data breach means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed
genetic data means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question
biometric data means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data
data concerning health means personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status
main establishment means: (a) as regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the Decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such Decisions implemented, in which case the establishment having taken such Decisions is to be considered to be the main establishment; (b) as regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation
representative means a natural or legal person established in the Union who, designated by the controller or processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective obligations under this Regulation
enterprise means a natural or legal person engaged in an economic activity, irrespective of its legal form, including partnerships or associations regularly engaged in an economic activity
group of undertakings means a controlling undertaking and its controlled undertakings
binding corporate rules means personal data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a joint economic activity
supervisory authority means an independent public authority which is established by a Member State pursuant to Article 51
supervisory authority concerned means a supervisory authority which is concerned by the processing of personal data because: (a) the controller or processor is established on the territory of the Member State of that supervisory authority; (b) data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be substantially affected by the processing; or (c) a complaint has been lodged with that supervisory authority
cross-border processing means either: (a) processing of personal data which takes place in the context of the activities of establishments in more than one Member State of a controller or processor in the Union where the controller or processor is established in more than one Member State; or (b) processing of personal data which takes place in the context of the activities of a single establishment of a controller or processor in the Union but which substantially affects or is likely to substantially affect data subjects in more than one Member State
relevant and reasoned objection means an objection to a draft Decision as to whether there is an infringement of this Regulation, or whether envisaged action in relation to the controller or processor complies with this Regulation, which clearly demonstrates the significance of the risks posed by the draft Decision as regards the fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the Union
information society service means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the Europen Parliament and of the Council
international organisation means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries
official shall mean any 'Community' or 'national' official, including any national official of another Member State
Community official shall mean: any person who is an official or other contracted employee within the meaning of the Staff Regulations of officials of the European Communities or the Conditions of employment of other servants of the European Communities, any person seconded to the European Communities by the Member States or by any public or private body, who carries out functions equivalent to those performed by European Community officials or other servants. Members of bodies set up in accordance with the Treaties establishing the European Communities and the staff of such bodies shall be treated as Community officials, inasmuch as the Staff Regulations of the European Communities or the Conditions of employment of other servants of the European Communities do not apply to them
national official shall be understood by reference to the definition of 'official` or 'public officer` in the national law of the Member State in which the person in question performs that function for the purposes of application of the criminal law of that Member State. Nevertheless, in the case of proceedings involving a Member State's official initiated by another Member State the latter shall not be bound to apply the definition of 'national official` except in so far as that definition is compatible with its national law
Convention shall mean the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities' financial interests, of 26 July 1995
Convention hall mean the Convention drawn up on the basis of Article K.3 of the Treaty on European Union on the protection of the European Communities' financial interests, of 26 July 1995
fraud shall mean the conduct referred to in Article 1 of the Convention
passive corruption shall mean the conduct referred to in Article 2 of the Protocol drawn up on the basis of Article K.3 of the Treaty on European Union to the convention on the protection of the European Communities' financial interests, of 27 September 1996
active corruption shall mean the conduct referred to in Article 3 of the same Protocol
legal person shall mean any entity having such status under the applicable national law, except for States or other public bodies in the exercise of State authority and for public international organizations
money laundering shall mean the conduct as defined n the third indent of Article 1 of Council Directive 91/308/EEC of 10 June 1991 on the prevention of the use of the financial system for the purpose of money laundering, related to the proceeds of fraud, at least in serious cases, and of active and passive corruption
closure means the completion of all operations at some time after the emplacement of spent fuel or radioactive waste in a disposal facility, including the final engineering or other work required to bring the facility to a condition that will be safe in the long term
competent regulatory authority means an authority or a system of authorities designated in a Member State in the field of Regulation of the safety of spent fuel or radioactive waste management as referred to in Article 6
disposal means the emplacement of spent fuel or radioactive waste in a facility without the intention of retrieval
disposal facility means any facility or installation the primary purpose of which is radioactive waste disposal
licence means any legal document granted under the jurisdiction of a Member State to carry out any activity related to the management of spent fuel or radioactive waste, or to confer responsibility for siting, design, construction, Commissioning, operation, deCommissioning or closure of a spent fuel management facility or of a radioactive waste management facility
licence holder means a legal or natural person having overall responsibility for any activity or facility related to the management of spent fuel or radioactive waste as specified in a licence
radioactive waste means radioactive material in gaseous, liquid or solid form for which no further use is foreseen or considered by the Member State or by a legal or natural person whose Decision is accepted by the Member State, and which is regulated as radioactive waste by a competent regulatory authority under the legislative and regulatory framework of the Member State
radioactive waste management means all activities that relate to handling, pretreatment, treatment, conditioning, storage, or disposal of radioactive waste, excluding off-site transportation
radioactive waste management facility means any facility or installation the primary purpose of which is radioactive waste management
reprocessing means a process or operation, the purpose of which is to extract fissile and fertile materials from spent fuel for further use
spent fuel means nuclear fuel that has been irradiated in and permanently removed from a reactor core; spent fuel may either be considered as a usable resource that can be reprocessed or be destined for disposal if regarded as radioactive waste
spent fuel management means all activities that relate to the handling, storage, reprocessing, or disposal of spent fuel, excluding off-site transportation
spent fuel management facility means any facility or installation the primary purpose of which is spent fuel management
storage means the holding of spent fuel or of radioactive waste in a facility with the intention of retrieval
transit shall mean a procedure under which goods are carried under the control of the competent authorities from one Contracting Party to another Contracting Party or to the same Contracting Party over at least one frontier
country shall mean any common transit country, any Member State of the Community, or any other State which has acceded to this Convention
third country shall mean any State which is not Contracting Party to this Convention
common transit country shall mean any country, other than a Member State of the Community, that is a Contracting Party to this Convention
customs authorities means the customs administrations responsible for applying the Convention and any other authorities empowered under national law to apply the Convention
person means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under the Union law, national law or the law of a common transit country as having capacity to perform legal acts
transit declaration means the act whereby a person indicates in the prescribed form and manner a wish to place goods under the common transit procedure
transit accompanying document means document printed using electronic data-processing techniques to accompany the goods and based on the particulars of the transit declaration
declarant means the person lodging a transit declaration in his own name or the person in whose name such a declaration is lodged
holder of the procedure means the person who lodges the transit declaration, or on whose behalf that declaration is lodged
customs office of departure means the customs office where a transit declaration is accepted
customs office of transit means the customs office competent for the point of entry into the customs territory of a Contracting Party when the goods move under the common transit procedure, or the customs office competent for the point of exit from the customs territory of a Contracting Party when the goods are leaving that territory in the course of a transit operation via a frontier between that Contracting Party and a third country
customs office of destination means the customs office where goods placed under the common transit procedure are presented in order to end the procedure
Master Reference Number (MRN) means the registration number allocated to a transit declaration by the competent customs authority using electronic data processing techniques
customs office of guarantee means the customs office where the customs authorities of each country decide that guarantees are to be lodged
debt means the obligation on a person to pay the amount of import or export duties and other charges due in respect of goods placed under the common transit procedure
debtor means any person liable for a debt
release of goods means the act whereby the customs authorities make goods available for the purposes specified for the common transit procedure under which they are placed
person established in the customs territory of a Contracting Party means: in the case of a natural person, any person who has his or her habitual residence in the customs territory of that Contracting Party; in the case of a legal person or an association of persons, any person having its registered office, central headquarters or a permanent business establishment in the customs territory of that Contracting Party
electronic data-processing techniques means electronic information exchange between economic operators and customs authorities, among customs authorities and between customs authorities and other involved governmental or European or common transit countries' agencies or institutions in an agreed and defined format with a purpose of automated processing and storage of the data after reception using any of the following means: (i) electronic data interchange; (ii) computer-to-computer interchange; (iii) electronic transfer of structured data by standard messages or services from one electronic processing environment to another without human intervention; (iv) online introduction of data into customs data-processing systems for storage and processing resulting in online responses
electronic data interchange (EDI) means an electronic transmission of data, structured in accordance with agreed message standards, between two computer systems
electronic transit system means electronic system used for the electronic data interchange of the common transit procedure
standard message means a predefined structure for the electronic transmission of data
personal data means any information relating to an identified or identifiable person
fixed transport installation means technical means (e.g. pipelines and electric power lines) used for continuous transport of goods
business continuity procedure means procedure based on the use of paper documents, established to allow the lodging of the transit declaration and follow-up of the transit operation where it is not possible to use the procedure based on electronic data-processing techniques
applicant authority means the competent authority of a country which makes a request for assistance concerning a claim referred to in Article 3
requested authority means the competent authority of a country to which a request for assistance is made
public sector body means the State, regional or local authorities, bodies governed by public law and associations formed by one or several such authorities or one or several such bodies governed by public law
body governed by public law means any body: (a) established for the specific purpose of meeting needs in the general interest, not having an industrial or commercial character; and (b) having legal personality; and (c) financed, for the most part by the State, or regional or local authorities, or other bodies governed by public law; or subject to management supervision by those bodies; or having an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities or by other bodies governed by public law
document means: (a) any content whatever its medium (written on paper or stored in electronic form or as a sound, visual or audiovisual recording); (b) any part of such content
re-use means the use by persons or legal entities of documents held by public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the documents were produced. Exchange of documents between public sector bodies purely in pursuit of their public tasks does not constitute re-use
personal data means data as defined in Article 2(a) of Directive 95/46/EC
machine-readable format means a file format structured so that software applications can easily identify, recognize and extract specific data, including individual statements of fact, and their internal structure
open format means a file format that is platform-independent and made available to the public without any restriction that impedes the re-use of documents
formal open standard means a standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability
university means any public sector body that provides post-secondary-school higher education leading to academic degrees
original work of art means works of graphic or plastic art such as pictures, collages, paintings, drawings, engravings, prints, lithographs, sculptures, tapestries, ceramics, glassware and photographs, provided they are made by the artist himself or are copies considered to be original works of art
rental means making available for use, for a limited period of time and for direct or indirect economic or commercial advantage
lending means making available for use, for a limited period of time and not for direct or indirect economic or commercial advantage, when it is made through establishments which are accessible to the public
film means a cinematographic or audiovisual work or moving images, whether or not accompanied by sound
collective management organisation means any organisation which is authorised by law or by way of assignment, licence or any other contractual arrangement to manage copyright or rights related to copyright on behalf of more than one rightholder, for the collective benefit of those rightholders, as its sole or main purpose, and which fulfils one or both of the following criteria: (i) it is owned or controlled by its members; (ii) it is organised on a not-for-profit basis
independent management entity means any organisation which is authorised by law or by way of assignment, licence or any other contractual arrangement to manage copyright or rights related to copyright on behalf of more than one rightholder, for the collective benefit of those rightholders, as its sole or main purpose, and which is: (i) neither owned nor controlled, directly or indirectly, wholly or in part, by rightholders; and (ii) organised on a for-profit basis
rightholder means any person or entity, other than a collective management organisation, that holds a copyright or related right or, under an agreement for the exploitation of rights or by law, is entitled to a share of the rights revenue
member means a rightholder or an entity representing rightholders, including other collective management organisations and associations of rightholders, fulfilling the membership requirements of the collective management organisation and admitted by it
statute means the memorandum and articles of association, the statute, the rules or documents of constitution of a collective management organisation
general assembly of members means the body in the collective management organisation wherein members participate and exercise their voting rights, regardless of the legal form of the organisation
director means: (i) where national law or the statute of the collective management organisation provides for a unitary board, any member of the administrative board; (ii) where national law or the statute of the collective management organisation provides for a dual board, any member of the management board or the supervisory board
rights revenue means income collected by a collective management organisation on behalf of rightholders, whether deriving from an exclusive right, a right to remuneration or a right to compensation
management fees means the amounts charged, deducted or offset by a collective management organisation from rights revenue or from any income arising from the investment of rights revenue in order to cover the costs of its management of copyright or related rights
representation agreement means any agreement between collective management organisations whereby one collective management organisation mandates another collective management organisation to manage the rights it represents, including an agreement concluded under Articles 29 and 30
user means any person or entity that is carrying out acts subject to the authorisation of rightholders, remuneration of rightholders or payment of compensation to rightholders and is not acting in the capacity of a consumer
repertoire means the works in respect of which a collective management organisation manages rights
multi-territorial licence means a licence which covers the territory of more than one Member State
online rights in musical works means any of the rights of an author in a musical work provided for under Articles 2 and 3 of Directive 2001/29/EC which are required for the provision of an online service
relevance denotes the degree to which statistics meet current and potential users' needs. It refers to whether all statistics that are needed are produced and the extent to which concepts used (definitions, classifications, etc.) reflect user needs
accuracy in the general statistical sense denotes the closeness of computations or estimates to the exact or true values of the variables under consideration
punctuality refers to the time lag between the release date of data and the target date when it should have been delivered, for instance with reference to dates announced in official release calendars, laid down by Regulations or previously agreed among partners
timeliness timeliness of information reflects the length of time between its availability and the event or phenomenon it describes
accessibility refers to the physical conditions in which users can obtain data: where to go, how to get access, delivery time, convenient marketing conditions (copyright, etc.), availability of micro or macro data, various formats and data carriers (paper, files, CD-ROM/DVD, Internet), etc.
clarity refers to the degree of comprehensibility, including data information environment, i.e. whether data are accompanied by appropriate metadata, illustrations such as graphs and maps, whether information on their quality is available (including limitations on use) and the extent to which additional assistance is provided
comparability aims at measuring the impact of differences in applied statistical concepts and measurement tools/procedures when statistics are compared between geographical areas, non-geographical domains, or over time
coherence coherence of statistics is the extent to which they can be reliably combined in different ways and for various uses. It is, however, generally easier to identify cases of incoherence than to prove coherence
network and information system means: (a) an electronic communications network within the meaning of point (a) of Article 2 of Directive 2002/21/EC; (b) any device or group of interconnected or related devices, one or more of which, pursuant to a program, perform automatic processing of digital data; or (c) digital data stored, processed, retrieved or transmitted by elements covered under points (a) and (b) for the purposes of their operation, use, protection and maintenance
security of network and information systems means the ability of network and information systems to resist, at a given level of confidence, any action that compromises the availability, authenticity, integrity or confidentiality of stored or transmitted or processed data or the related services offered by, or accessible via, those network and information systems
national strategy on the security of network and information systems means a framework providing strategic objectives and priorities on the security of network and information systems at national level
operator of essential services means a public or private entity of a type referred to in Annex II, which meets the criteria laid down in Article 5(2)
digital service means a service within the meaning of point (b) of Article 1(1) of Directive (EU) 2015/1535 of the Europen Parliament and of the Council which is of a type listed in Annex III
digital service provider means any legal person that provides a digital service
incident means any event having an actual adverse effect on the security of network and information systems
incident handling means all procedures supporting the detection, analysis and containment of an incident and the response thereto
risk means any reasonably identifiable circumstance or event having a potential adverse effect on the security of network and information systems
representative means any natural or legal person established in the Union explicitly designated to act on behalf of a digital service provider not established in the Union, which may be addressed by a national competent authority or a CSIRT instead of the digital service provider with regard to the obligations of that digital service provider under this Directive
standard means a standard within the meaning of point (1) of Article 2 of Regulation (EU) No 1025/2012
specification means a technical specification within the meaning of point (4) of Article 2 of Regulation (EU) No 1025/2012
internet exchange point (IXP) means a network facility which enables the interconnection of more than two independent autonomous systems, primarily for the purpose of facilitating the exchange of internet traffic; an IXP provides interconnection only for autonomous systems; an IXP does not require the internet traffic passing between any pair of participating autonomous systems to pass through any third autonomous system, nor does it alter or otherwise interfere with such traffic
domain name system (DNS) means a hierarchical distributed naming system in a network which refers queries for domain names
DNS service provider means an entity which provides DNS services on the internet
top-level domain name registry means an entity which administers and operates the registration of internet domain names under a specific top-level domain (TLD)
online marketplace means a digital service that allows consumers and/or traders as respectively defined in point (a) and in point (b) of Article 4(1) of Directive 2013/11/EU of the Europen Parliament and of the Council to conclude online sales or service contracts with traders either on the online marketplace's website or on a trader's website that uses computing services provided by the online marketplace
online search engine means a digital service that allows users to perform searches of, in principle, all websites or websites in a particular language on the basis of a query on any subject in the form of a keyword, phrase or other input, and returns links in which information related to the requested content can be found
cloud computing service means a digital service that enables access to a scalable and elastic pool of shareable computing resources
death means the permanent disappearance of all evidence of life at any time after live birth has taken place (post-natal cessation of vital functions without capability of resuscitation). This definition excludes stillbirths
stillbirth means foetal death, namely death prior to the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of pregnancy. Death is indicated by the fact that after such separation from its mother the foetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles
gestational age means the duration of gestation, measured from the first day of the last normal menstrual period. Gestational age is expressed in completed days or completed weeks
neonatal death means the death occurring among live births during the first 28 completed days of life (days 0-27)
parity means the number of previous live births or stillbirths (0, 1, 2, 3 or more previous live births or stillbirths)
other deaths means the deaths occurring after the neonatal death period from the 28th completed day of life onwards
underlying cause of death means the disease or injury which initiated the train of morbid events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury
resident means ‘usual resident’ in the place where a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holidays, visits to friends and relatives, business, medical treatment or religious pilgrimage. The following persons alone shall be considered to be usual residents of the geographical area in question: (i) those who have lived in their place of usual residence for a continuous period of at least 12 months before the reference date; or (ii) those who arrived in their place of usual residence during the 12 months before the reference date with the intention of staying there for at least 1 year. Where the circumstances described in point (i) or (ii) cannot be established, ‘usual residence’ shall mean the place of legal or registered residence
worker any person employed by an employer, including trainees and apprentices but excluding domestic servants
employer any natural or legal person who has an employment relationship with the worker and has responsibility for the undertaking and/ or establishment
workers’ representative with specific responsibility for the safety and health of workers any person elected, chosen or designated in accordance with national laws and/ or practices to represent workers where problems arise relating to the safety and health protection of workers at work
prevention all the steps or measures taken or planned at all stages of work in the undertaking to prevent or reduce occupational risks
manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark
importer is a natural or legal person established in the Union who places a product from a third country on the EU market
distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
harmonised standards are ‘European standards’ adopted, upon a request made by the Commission for the application of Union harmonisation legislation. Harmonised standards maintain their status of voluntary application
European standards are ‘standards’ adopted by the European standardisation organisations (ESOs) listed in Annex I to Regulation (EU) No 1025/2012
standards are defined as technical specifications, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory
the CE marking is a key indicator (but not proof) of a product's compliance with EU legislation and enables the free movement of products within the EEA and Turkish market, whether they are manufactured in the EEA, Turkey or in another country. The CE marking indicates the conformity of the product with the Union legislation applying to the product and providing for CE marking. CE marking does not indicate that a product was made in the European Union. The CE marking indicates conformity with the requirements laid down by the Union harmonisation text(s) in question. Therefore, it is to be considered as essential information to Member States' authorities as well as other relevant parties (for example distributors). CE marking does not serve commercial purposes, i.e. it is not a marketing tool. CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense and indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation.
conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled. Conformity assessment must not be confused with market surveillance, which consists of controls by the national market surveillance authorities after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the protection of the public interests at stake and the smooth functioning of the internal market. The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.
conformity assessment body is a body that performs one or several elements of conformity assessment, including one or several of the following activities: calibration, testing, certification and inspection. Notified bodies are conformity assessment bodies which have been officially designated by their national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required. They are called ‘notified bodies’ under EU legislation. Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable technical harmonisation legislation when a third party is required
notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodies under Union harmonisation legislation. Most often it is the national administration responsible for the implementation and management of the Union harmonisation act under which the body is notified. Each Member State must designate a notifying authority to be responsible for the assessment, notification and monitoring of conformity assessment bodies.
notification is the act of the notifying authority informing the Commission and the other Member States that a conformity assessment body has been designated to carry out conformity assessment according to a Union harmonisation act, and fulfils the requirements relating to notified bodies set out in that Union harmonisation act
accreditation is the attestation by a national accreditation body based on harmonised standards that a conformity assessment body has the technical competence to perform a specific conformity assessment activity. Accreditation is based on the international standards for conformity assessment bodies that have been harmonised in the New Legislative Framework and the references of which have been published in the Official Journal of the European Union.
manufacturer’s declaration of conformity The EU declaration of conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product
water pump is the hydraulic part of a device that moves clean water by physical or mechanical action and is of one of the following designs: end suction own bearing (ESOB), end suction close coupled (ESCC), end suction close coupled inline (ESCCi), vertical multistage (MS-V), submersible multistage (MSS)
end suction water pump means a glanded single stage end suction rotodynamic water pump designed for pressures up to 16 bar, with a specific speed ns between 6 and 80 rpm, a minimum rated flow of 6 m3/h (1,667·10–3 m3/s), a maximum shaft power of 150 kW, a maximum head of 90 m at nominal speed of 1 450 rpm and a maximum head of 140 m at nominal speed of 2 900 rpm
rated flow means the head and flow that the manufacturer will guarantee under normal operating conditions
glanded means sealed shaft connection between the impeller in the pump body and the motor. The driving motor component remains dry
end suction own bearing water pump (ESOB) is an end suction water pump with own bearings
end suction close coupled water pump (ESCC) is an end suction water pump of which the motor shaft is extended to become also the pump shaft
end suction close coupled inline water pump (ESCCi) means a water pump of which the water inlet of the pump is on the same axis as the water outlet of the pump
vertical multistage water pump (MS-V) means a glanded multi stage (i > 1) rotodynamic water pump in which the impellers are assembled on a vertical rotating shaft, which is designed for pressures up to 25 bar, with a nominal speed of 2 900 rpm and a maximum flow of 100 m3/h (27,78·10–3 m3/s)
submersible multistage water pump (MSS) means a multi stage (i > 1) rotodynamic water pump with a nominal outer diameter of 4″ (10,16 cm) or 6″ (15,24 cm) designed to be operated in a borehole at nominal speed of 2 900 rpm, at operating temperatures within a range of 0 °C and 90 °C
rotodynamic water pump means a water pump that moves clean water by means of hydrodynamic forces
displacement water pump means a water pump that moves clean water by enclosing a volume of clean water and forcing this volume to the outlet of the pump
self-priming water pump means a water pump that moves clean water and which can start and/or operate also when only partly filled with water
clean water means water with a maximum non-absorbent free solid content of 0,25 kg/m3, and with a maximum dissolved solid content of 50 kg/m3, provided that the total gas content of the water does not exceed the saturation volume. Any additives that are needed to avoid water freezing down to – 10 °C shall not be taken into account
impeller means the rotating component of a rotodynamic pump which transfers energy to the water
full impeller means the impeller with the maximum diameter for which performance characteristics are given for a pump size in the catalogues of a water pump manufacturer
specific speed (ns) means a dimensional value characterising the shape of the water pump impeller by head, flow and speed (n):
[ФОРМУЛА1] [min–1]
Where ‘Head’ (H) means the increase in the hydraulic energy of water in meters [m], produced by the water pump at the specified point of operation, ‘Rotational speed’ (n) means the number of revolutions per minute [rpm] of the shaft, ‘Flow’ (Q) means the volume flow rate [m3/s] of water through the water pump, ‘Stage’ (i) means the number of series impellers in the water pump, ‘Best efficiency point’ (BEP) means the operating point of the water pump at which it is at the maximum hydraulic pump efficiency measured with clean cold water
hydraulic pump efficiency (η) is the ratio between the mechanical power transferred to the liquid during its passage through the water pump and the mechanical input power transmitted to the pump at its shaft
clean cold water means clean water to be used for pump testing, with a maximum kinematic viscosity of 1,5 × 10–6 m2/s, a maximum density of 1 050 kg/m3 and a maximum temperature of 40 °C
part load (PL) means the operating point of the water pump at 75% of the flow at BEP
over load (OL) means the operating point of the water pump at 110% of the flow at BEP
Minimum Efficiency Index (MEI) means the dimensionless scale unit for hydraulic pump efficiency at BEP, PL and OL
C means a constant for each specific water pump type quantifying the differences in efficiency for different pump types
making available on the market shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market shall mean the first making available of a product on the Community market
manufacturer shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark
authorised representative shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation
importer shall mean any natural or legal person established within the Community who places a product from a third country on the Community market
distributor shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
economic operators shall mean the manufacturer, the authorised representative, the importer and the distributor
technical specification shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service
harmonised standard shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services on the basis of a request made by the Commission in accordance with Article 6 of that Directive
accreditation shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity
national accreditation body shall mean the sole body in a Member State that performs accreditation with authority derived from the State
conformity assessment shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled
conformity assessment body shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall shall mean any measure aimed at achieving the return of a product that has already been made available to the end user
withdrawal shall mean any measure aimed at preventing a product in the supply chain from being made available on the market
peer evaluation shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications
market surveillance shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection
market surveillance authority shall mean an authority of a Member State responsible for carrying out market surveillance on its territory
release for free circulation shall mean the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code
CE marking shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing
Community harmonisation legislation shall mean any Community legislation harmonising the conditions for the marketing of products
air conditioner means a device capable of cooling or heating, or both, indoor air, using a vapour compression cycle driven by an electric compressor, including air conditioners that provide additional functionalities such as dehumidification, air-purification, ventilation or supplemental air-heating by means of electric resistance heating, as well as appliances that may use water (either condensate water that is formed on the evaporator side or externally added water) for evaporation on the condenser, provided that the device is also able to function without the use of additional water, using air only
double duct air conditioner means an air conditioner in which, during cooling or heating, the condenser (or evaporator) intake air is introduced from the outdoor environment to the unit by a duct and rejected to the outdoor environment by a second duct, and which is placed wholly inside the space to be conditioned, near a wall
single duct air conditioner means an air conditioner in which, during cooling or heating, the condenser (or evaporator) intake air is introduced from the space containing the unit and discharged outside this space
rated capacity (Prated) means the cooling or heating capacity of the vapour compression cycle of the unit at standard rating conditions
comfort fan means an appliance primarily designed for creating air movement around or on part of a human body for personal cooling comfort, including comfort fans that can perform additional functionalities such as lighting
fan power input (PF) means the electric power input of a comfort fan in Watt operating at the declared maximum fan flow rate, measured with the oscillating mechanism active (if/when applicable)
reversible air conditioner means an air conditioner capable of both cooling and heating
standard rating conditions means the combination of indoor (Tin) and outdoor temperatures (Tj) that describe the operating conditions while establishing the sound power level, rated capacity, rated air flow rate, rated energy efficiency ratio (EERrated ) and/or rated coefficient of performance (COPrated ), as set out in Annex II, Table 2
indoor temperature (Tin) means the dry bulb indoor air temperature [°C] (with the relative humidity indicated by the corresponding wet bulb temperature)
outdoor temperature (Tj) means the dry bulb outdoor air temperature [°C] (with the relative humidity indicated by the corresponding wet bulb temperature)
rated energy efficiency ratio (EERrated) means the declared capacity for cooling [kW] divided by the rated power input for cooling [kW] of a unit when providing cooling at standard rating conditions
rated coefficient of performance (COPrated) means the declared capacity for heating [kW] divided by the rated power input for heating [kW] of a unit when providing heating at standard rating conditions
global warming potential (GWP) means the measure of how much 1 kg of the refrigerant applied in the vapour compression cycle is estimated to contribute to global warming, expressed in kg CO2 equivalents over a 100-year time horizon; GWP values considered will be those set out in Annex I to Regulation (EC) No 842/2006; for fluorinated refrigerants, the GWP values shall be those published in the Third Assessment Report (TAR), adopted by the Intergovernmental Panel on Climate Change (2001 IPCC GWP values for a 100-year period); for non-fluorinated gases, the GWP values are those published in the first IPCC assessment over a 100-year period; GWP values for mixtures of refrigerants shall be based on the formula stated in Annex I to Regulation (EC) No 842/2006; for refrigerants not included in the above references, the IPCC UNEP 2010 report on Refrigeration, Air Conditioning and Heat Pumps, dated February 2011, or newer, shall be used as a reference
off mode is a condition in which the air conditioner or comfort fan is connected to the mains power source and is not providing any function. Also considered as off mode are conditions providing only an indication of off mode condition, as well as conditions providing only functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2004/108/EC of the European Parliament and of the Council
standby mode means a condition where the equipment (air conditioner or comfort fan) is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
reactivation function means a function facilitating the activation of other modes, including active mode, by remote switch including remote control, internal sensor, timer to a condition providing additional functions, including the main function
information or status display is a continuous function providing information or indicating the status of the equipment on a display, including clocks
sound power level means the A-weighted sound power level [dB(A)] indoors and/or outdoors measured at standard rating conditions for cooling (or heating, if the product has no cooling function)
reference design conditions means the combination of requirements for the reference design temperature, the maximum bivalent temperature and the maximum operation limit temperature, as set out in Annex II, Table 3
reference design temperature means the outdoor temperature [°C] for either cooling (Tdesignc) or heating (Tdesignh) as described in Annex II, Table 3, at which the part load ratio shall be equal to 1, and which varies according the designated cooling or heating season
part load ratio (pl(Tj)) means the outdoor temperature minus 16 °C, divided by the reference design temperature minus 16 °C, for either cooling or heating
season means one of the four sets of operating conditions (available for four seasons: one cooling season, three heating seasons: average/colder/warmer) describing per bin the combination of outdoor temperatures and the number of hours these temperatures occur per season for which the unit is declared fit for purpose
bin (with index j) means a combination of an outdoor temperature (Tj) and bin hours (hj), as set out in Annex II, Table 1
bin hours means the hours per season (hj) the outdoor temperature occurs for each bin, as set out in Annex II, Table 1
seasonal energy efficiency ratio (SEER) is the overall energy efficiency ratio of the unit, representative for the whole cooling season, calculated as the Reference annual cooling demand divided by the annual electricity consumption for cooling
reference annual cooling demand (QC) means the reference cooling demand [kWh/a] to be used as basis for calculation of SEER and calculated as the product of the design load for cooling (Pdesignc) and the equivalent active mode hours for cooling (HCE)
equivalent active mode hours for cooling (HCE) means the assumed annual number of hours [h/a] the unit must provide the design load for cooling (Pdesignc) in order to satisfy the reference annual cooling demand, as set out in Annex II, Table 4
annual electricity consumption for cooling (QCE) means the electricity consumption [kWh/a] required to meet the reference annual cooling demand and is calculated as the reference annual cooling demand divided by the active mode seasonal energy efficiency ratio (SEERon), and the electricity consumption of the unit for thermostat off-, standby-, off- and crankcase heater-mode during the cooling season
active mode seasonal energy efficiency ratio (SEERon) means the average energy efficiency ratio of the unit in active mode for the cooling function, constructed from part load and bin-specific energy efficiency ratio's (EERbin(Tj)) and weighted by the bin hours the bin condition occurs
part load means the cooling load (Pc(Tj)) or the heating load (Ph(Tj)) [kW] at a specific outdoor temperature Tj, calculated as the design load multiplied by the part load ratio
bin-specific energy efficiency ratio (EERbin(Tj)) means the energy efficiency ratio specific for every bin j with outdoor temperature Tj in a season, derived from the part load, declared capacity and declared energy efficiency ratio (EERd(Tj)) for specified bins (j) and calculated for other bins through inter/extrapolation, when necessary corrected by the degradation coefficient
seasonal coefficient of performance (SCOP) is the overall coefficient of performance of the unit, representative for the whole designated heating season (the value of SCOP pertains to a designated heating season), calculated as the reference annual heating demand divided by the annual electricity consumption for heating
reference annual heating demand (QH) means the reference heating demand [kWh/a], pertaining to a designated heating season, to be used as basis for calculation of SCOP and calculated as the product of the design load for heating (Pdesignh) and the seasonal equivalent active mode hours for heating (HHE)
equivalent active mode hours for heating (HHE) means the assumed annual number of hours [h/a] the unit must provide the design load for heating (Pdesignh) in order to satisfy the reference annual heating demand, as set out in Annex II, Table 4
annual electricity consumption for heating (QHE) means the electricity consumption [kWh/a] required to meet the indicated reference annual heating demand and which pertains to a designated heating season; and is calculated as the reference annual heating demand divided by the active mode seasonal coefficient of performance (SCOPon), and the electricity consumption of the unit for thermostat off-, standby-, off- and crankcase heater-mode during the heating season
active mode seasonal coefficient of performance (SCOPon) means the average coefficient of performance of the unit in active mode for the designated heating season, constructed from the part load, electric back up heating capacity (where required) and bin-specific coefficients of performance (COPbin(Tj) and weighted by the bin hours the bin condition occurs
electric back-up heater capacity (elbu(Tj)) is the heating capacity [kW] of a real or assumed electric back-up heater with COP of 1 that supplements the declared capacity for heating (Pdh(Tj)) in order to meet the part load for heating (Ph(Tj)) in case Pdh(Tj) is less than Ph(Tj), for the outdoor temperature (Tj)
bin-specific coefficient of performance (COPbin(Tj)) means the coefficient of performance specific for every bin j with outdoor temperature Tj in a season, derived from the part load, declared capacity and declared coefficient of performance (COPd(Tj)) for specified bins (j) and calculated for other bins through inter/extrapolation, when necessary corrected by the degradation coefficient
declared capacity [kW] is the capacity of the vapour compression cycle of the unit for cooling (Pdc(Tj)) or heating (Pdh(Tj)), pertaining to an outdoor temperature Tj and indoor temperature (Tin), as declared by the manufacturer
service value (SV) [(m3/min)/W] means for comfort fans the ratio of the maximum fan flow rate [m3/min] and the fan power input [W]
capacity control means the ability of the unit to change its capacity by changing the volumetric flow rate. Units are to be indicated as ‘fixed’ if the unit can not change its volumetric flow rate, ‘staged’ if the volumetric flow rate is changed or varied in series of not more than two steps, or ‘variable’ if the volumetric flow rate is changed or varied in series of three or more steps
function means the indication of whether the unit is capable of indoor air cooling, indoor air heating or both
design load means the declared cooling load (Pdesignc) and/or declared heating load (Pdesignh) [kW] at the reference design temperature, whereby for cooling mode, Pdesignc is equal to the declared capacity for cooling at Tj equal to Tdesignc; for heating mode, Pdesignh is equal to the part load at Tj equal to Tdesignh
declared energy efficiency ratio (EERd(Tj)) means the energy efficiency ratio at a limited number of specified bins (j) with outdoor temperature (Tj), as declared by the manufacturer
declared coefficient of performance (COPd(Tj)) means the coefficient of performance at a limited number of specified bins (j) with outdoor temperature (Tj), as declared by the manufacturer
bivalent temperature (Tbiv) means the outdoor temperature (Tj) [°C] declared by the manufacturer for heating at which the declared capacity equals the part load and below which the declared capacity must be supplemented with electric back up heater capacity in order to meet the part load for heating
operation limit temperature (Tol) means the outdoor temperature [°C] declared by the manufacturer for heating, below which air conditioner will not be able to deliver any heating capacity. Below this temperature, the declared capacity is equal to zero
cycling interval capacity [kW] is the (time-weighted) average of the declared capacity over the cycling test interval for cooling (Pcycc) or heating (Pcych)
cycling interval efficiency for cooling (EERcyc) is the average energy efficiency ratio over the cycling test interval (compressor switching on and off), calculated as the integrated cooling capacity over the interval [kWh] divided by the integrated electric power input over that same interval [kWh]
cycling interval efficiency for heating (COPcyc) is the average coefficient of performance over the cycling test interval (compressor switching on and off), calculated as the integrated heating capacity over the interval [kWh] divided by the integrated electric power input over that same interval [kWh]
degradation coefficient is the measure of efficiency loss due to cycling (compressor switching on/off in active mode) established for cooling (Cdc), heating (Cdh) or chosen as default value 0,25
active mode means the mode corresponding to the hours with a cooling or heating load of the building and whereby the cooling or heating function of the unit is activated. This condition may involve on/off-cycling of the unit in order to reach or maintain a required indoor air temperature
thermostat-off mode means a mode corresponding to the hours with no cooling or heating load whereby the cooling or heating function of the unit is switched on but the unit is not operational as there is no cooling or heating load. This condition is therefore related to outdoor temperatures and not to indoor loads. Cycling on/off in active mode is not considered as thermostat off
crankcase heater operation mode means a condition where the unit has activated a heating device to avoid the refrigerant migrating to the compressor in order to limit the refrigerant concentration in oil at compressor start
thermostat-off mode power consumption (PTO) means the power consumption of the unit [kW] while in thermostat-off mode
standby mode power consumption (PSB) means the power consumption of the unit [kW] while in standby mode
off-mode power consumption (POFF) means the power consumption of the unit [kW] while in off-mode
crankcase heater mode power consumption (PCK) means the power consumption of the unit [kW] while in crankcase heater operation mode
thermostat-off mode operating hours (HTO) means the annual number of hours [h/a] the unit is considered to be in thermostat-off mode, the value of which depends on the designated season and function
standby mode operating hours (HSB) means the annual number of hours [h/a] the unit is considered to be in standby mode, the value of which depends on the designated season and function
off-mode operating hours (HOFF) means the annual number of hours [h/a] the unit is considered to be in off-mode, the value of which depends on the designated season and function
crankcase heater mode operating hours (HCK) means the annual number of hours [h/a] the unit is considered to be in crankcase heater operation mode, the value of which depends on the designated season and function
nominal air flow rate means the air flow rate [m3/h] measured at the air outlet of indoor and/or outdoor units (if applicable) of air conditioners at standard rating conditions for cooling (or heating, if the product has no cooling function)
rated power input for cooling (PEER) means the electric power input [kW] of a unit when providing cooling at standard rating conditions
rated power input for heating (PCOP) means the electric power input [kW] of a unit when providing heating at standard rating conditions
electricity consumption of single and double ducts (QSD respectively QDD) means the electricity consumption of single or double duct air conditioners for the cooling and/or heating mode (whichever applies) [single duct in kWh/h, double duct in kWh/a]
capacity ratio means the ratio of the total declared cooling or heating capacity of all operating indoor units to the declared cooling or heating capacity of the outdoor unit at standard rating conditions
maximum fan flow rate (F) means the air flow rate of the comfort fan at its maximum setting [m3/min], measured at the fan outlet with the oscillating mechanism (if applicable) turned off
oscillating mechanism means the capability of the comfort fan to automatically vary the direction of the air flow while the fan is operating
fan sound power level means the A-weighted sound power level of the comfort fan while providing the maximum fan flow rate, measured at the outlet side
fan active mode hours (HCE) means the number of hours [h/a] the comfort fan is assumed to provide the maximum fan flow rate, as described in Annex II, Table 4
blood shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing
blood component shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods
blood product shall mean any therapeutic product derived from human blood or plasma
autologous transfusion shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used
blood establishment shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks
hospital blood bank shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities
serious adverse event shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity
serious adverse reaction shall mean an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity
blood component release shall mean a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification
deferral shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary
distribution shall mean the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion
haemovigilance shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors
inspection shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems
standard means the requirements that serve as the basis for comparison
specification means a description of the criteria that must be fulfilled in order to achieve the required quality standard
quality system means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management
quality management means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment
quality control means part of a quality system focussed on fulfilling quality requirements
quality assurance means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use
trace-back means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor
written procedures means controlled documents that describe how specified operations are to be carried out
mobile site means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment
processing means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component
good practice means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations
quarantine means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents
validation means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled
qualification as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results
computerised system means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation
autologous donation means blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual
allogeneic donation means blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material/raw material for manufacturing into medicinal products
validation means the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled
whole blood means a single blood donation
cryopreservation means prolongation of the storage life of blood components by freezing
plasma means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryoprecipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion or perinatal transfusion
cryoprecipitate means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma
washed means a process of removing plasma or storage medium from cellular products by centrifugation, decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting, replacing process may be repeated several times
red cells means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed
red cells, buffy coat removed means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed
red cells, leucocyte-depleted means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed
red cells in additive solution means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. A nutrient/preservative solution is added
additive solution means a solution specifically formulated to maintain beneficial properties of cellular components during storage
red cells, buffy coat removed, in additive solution means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed. A nutrient/preservative solution is added
buffy coat means a blood component prepared by centrifugation of a unit of whole blood, and which contains a considerable proportion of the leucocytes and platelets
red cells, leucocyte-depleted, in additive solution means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient/preservative solution is added
red cells, apheresis means the red cells from an apheresis red cell donation
apheresis means a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process
platelets, apheresis means a concentrated suspension of blood platelets obtained by apheresis
platelets, apheresis, leucocyte-depleted means a concentrated suspension of blood platelets, obtained by apheresis, and from which leucocytes are removed
platelets, recovered, pooled means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation
platelets, recovered, pooled, leucocyte-depleted means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation, and from which leucocytes are removed
platelets, recovered, single unit means a concentrated suspension of blood platelets, obtained by processing of a single unit of whole blood
platelets, recovered, single unit, leucocyte-depleted means a concentrated suspension of blood platelets, obtained by processing of a single whole blood unit from which leucocytes are removed
plasma, fresh-frozen means the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored
plasma, cryoprecipitate-depleted for transfusion means a plasma component prepared from a unit of plasma, fresh-frozen. It comprises the residual portion after the cryoprecipitate has been removed
granulocytes, apheresis means a concentrated suspension of granulocytes obtained by apheresis
statistical process control means a method of quality control of a product or a process that relies on a system of analysis of an adequate sample size without the need to measure every product of the process
firearm means any portable barrelled weapon that expels, is designed to expel or may be converted to expel, a shot, bullet or projectile by the action of a combustible propellant as referred to in Annex I. An object is considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if: it has the appearance of a firearm, and as a result of its construction or the material from which it is made, it can be so converted
parts means any element or replacement element as referred to in Annex I specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm
essential components means the breech-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted
ammunition means the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles that are used in a firearm, as referred to in Annex I, provided that those components are themselves subject to authorisation in the relevant Member State
deactivated firearms means objects otherwise corresponding to the definition of a firearm which have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or modification that would permit the firearm to be reactivated in any way. Member States shall make arrangements for these deactivation measures to be verified by a competent authority. Member States shall, in the context of that verification, provide for the issue of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm
export means: (a) an export procedure within the meaning of Article 161 of Regulation (EEC) No 2913/92; (b) a re-export within the meaning of Article 182 of Regulation (EEC) No 2913/92 but not including goods moving under the external transit procedure, as referred to in Article 91 of that Regulation where no re-export formalities as referred to in Article 182(2) thereof have been fulfilled
person means a natural person, a legal person and, where the possibility is provided for under the rules in force, an association of persons recognised as having the capacity to perform legal acts but lacking the legal status of a legal person
exporter means any person, established in the Union, who makes or on whose behalf an export declaration is made, that is to say the person who, at the time when the declaration is accepted, holds the contract with the consignee in the third country and has the power for determining the sending of the item out of the customs territory of the Union. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the exporter shall mean the person who has the power for determining the sending of the item out of the customs territory of the Union. Where the benefit of a right to dispose of firearms, their parts and essential components or ammunition accrues to a person established outside the Union pursuant to the contract on which the export is based, the exporter shall be considered to be the contracting party established in the Union
customs territory of the Union means the territory within the meaning of Article 3 of Regulation (EEC) No 2913/92
export declaration means the act whereby a person indicates in the prescribed form and manner his intention to place firearms, their parts and essential components, and ammunition under an export procedure
temporary export means the movement of firearms leaving the customs territory of the Union and intended for re-importation within a period not exceeding 24 months
transit means the operation of transport of goods leaving the customs territory of the Union and passing through the territory of one or more third countries with final destination in another third country
transhipment means transit involving the physical operation of unloading goods from the importing means of transport followed by reloading, for the purpose of re-exportation, generally onto another means of transport
export authorisation means: (a) a single authorisation or licence granted to one specific exporter for one shipment of one or more firearms, their parts and essential components and ammunition to one identified final recipient or consignee in a third country; or (b) a multiple authorisation or licence granted to one specific exporter for multiple shipments of one or more firearms, their parts and essential components and ammunition to one identified final recipient or consignee in a third country; or (c) a global authorisation or licence granted to one specific exporter for multiple shipments of one or more firearms, their parts and essential components and ammunition to several identified final recipients or consignees in one or several third countries
illicit trafficking means the import, export, sale, delivery, movement or transfer of firearms, their parts and essential components or ammunition from or across the territory of one Member State to that of a third country, if any of the following applies: (a) the Member State concerned does not authorise it in accordance with the terms of this Regulation; (b) the firearms are not marked in accordance with Article 4(1) and (2) of Directive 91/477/EEC; (c) the imported firearms are not marked at the time of import at least with a simple marking permitting identification of the first country of import within the European Union, or, where the firearms do not bear such a marking, a unique marking identifying the imported firearms
tracing means the systematic tracking of firearms and, where possible, their parts and essential components and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and trafficking
partly dehydrated milk This means the liquid product, whether or not sweetened, obtained by the partial removal of water from milk, from wholly or partly skimmed milk or from a mixture of these products, which may have an admixture of cream or of wholly dehydrated milk or both, the addition of wholly dehydrated milk not to exceed, in the finished products, 25% of total milk solids
totally dehydrated milk This means the solid product, where the water content does not exceed 5% by weight of the finished product, obtained by the removal of water from milk, from wholly or partly skimmed milk, from cream or from a mixture of these products
condensed high-fat milk Partly dehydrated milk containing, by weight, not less than 15% fat, and not less than 26,5% total milk solids
condensed milk Partly dehydrated milk containing, by weight, not less than 7,5% fat and not less than 25% total milk solids
condensed, partly skimmed milk Partly dehydrated milk containing, by weight, not less than 1% and less than 7,5% fat, and not less than 20% total milk solids
condensed skimmed milk Partly dehydrated milk containing, by weight, not more than 1% fat and not less than 20% total milk solids
sweetened condensed milk Partly dehydrated milk with an admixture of sucrose (semi-white sugar, white sugar or extra-white sugar) and containing, by weight, not less than 8% fat and not less than 28% total milk solids.
sweetened condensed, partly skimmed milk Partly dehydrated milk with an admixture of sucrose (semi-white sugar, white sugar or extra-white sugar) and containing, by weight, not less than 1% and less than 8% fat, and not less than 24% total milk solids
sweetened condensed skimmed milk Partly dehydrated milk with an admixture of sucrose (semi-white sugar, white sugar or extra-white sugar) and containing, by weight, not more than 1% fat and not less than 24% total milk solids
dried high-fat milk or high-fat milk powder Dehydrated milk containing, by weight, not less than 42% fat
dried whole milk or whole milk powder Dehydrated milk containing, by weight, not less than 26% and less than 42% fat
dried partly skimmed milk or partly skimmed-milk powder Dehydrated milk with a fat content of more than 1,5% and less than 26% by weight
dried skimmed milk or skimmed-milk powder Dehydrated milk containing, by weight, not more than 1,5% fat
transit movements in which the goods (military equipment) merely pass through the territory of a Member State
transhipment transit involving the physical operation of unloading goods from the importing means of transport followed by a reloading (generally) onto another exporting means of transport
brokering activities activities of persons and entities: negotiating or arranging transactions that may involve the transfer of items on the EU Common Military List from a third country to any other third country; or who buy, sell or arrange the transfer of such items that are in their ownership from a third country to any other third country
export licence is a formal authorisation issued by the national licensing authority to export or transfer military equipment on a temporary or definitive basis. Export licences include: licences for physical exports, including where these are for the purpose of licensed production of military equipment; brokering licences; transit or transhipment licences; licences for any intangible transfers of software and technology by means such as electronic media, fax or telephone
milk fats Products in the form of a solid, malleable emulsion, principally of the water-in-oil type, derived exclusively from milk and/or certain milk products, for which the fat is the essential constituent of value. However, other substances necessary for their manufacture may be added, provided those substances are not used for the purpose of replacing, either in whole or in part, any milk constituents
fats Products in the form of a solid, malleable emulsion, principally of the water-in-oil type, derived from solid and/or liquid vegetable and/or animal fats suitable for human consumption, with a milk-fat content of not more than 3% or the fat content
fats composed of plant and/or animal products Products in the form of a solid, malleable emulsion principally of the water-in-oil type, derived from solid and/or liquid vegetable and/or animal fats suitable for human consumption, with a milk-fat content of between 10% and 80% of the fat content
radioactive waste means radioactive material in gaseous, liquid or solid form for which no further use is foreseen by the countries of origin and destination, or by a natural or legal person whose decision is accepted by these countries, and which is controlled as radioactive waste by a regulatory body under the legislative and regulatory framework of the countries of origin and destination
spent fuel means nuclear fuel that has been irradiated in and permanently removed from a reactor core; spent fuel may either be considered as usable resource that can be reprocessed or be destined for final disposal with no further use foreseen and treated as radioactive waste
reprocessing means a process or operation, the purpose of which is to extract radioactive isotopes from spent fuel for further use
shipment means the whole of operations involved in moving radioactive waste or spent fuel from the country or the Member State of origin to the country or the Member State of destination
intra-community shipment means a shipment carried out where the country of origin and the country of destination are Member States
extra-community shipment means a shipment carried out where the country of origin and/or the country of destination are third countries
disposal means the emplacement of radioactive waste or spent fuel in an authorised facility without the intention of retrieval
storage means the holding of radioactive waste or spent fuel in a facility that provides for its containment, with the intention of retrieval
holder means any natural or legal person who, before carrying out a shipment of radioactive waste or spent fuel is responsible under the applicable national law for such materials and plans to carry out a shipment to a consignee
consignee means any natural or legal person to whom radioactive waste or spent fuel is shipped
‘country or Member State of origin’ and ‘country or Member State of destination’ respectively means any country or Member State from which a shipment is planned to be initiated or is initiated, and any country or Member State to which a shipment is planned or takes place
country or Member State of transit means any country or Member State other than the country or the Member State of origin or the country or the Member State of destination, through the territory of which a shipment is planned or takes place
competent authorities means any authority which, under the law or regulations of the countries of origin, transit or destination, are empowered to implement the system of supervision and control of shipments of radioactive waste or spent fuel
sealed source has the meaning given to it by Directive 96/29/Euratom and includes the capsule, where applicable, enclosing the radioactive material as an integral part of the source
disused source means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted
recognised installation means a facility located in the territory of a country authorised by the competent authorities of that country in accordance with national law for the long-term storage or disposal of sealed sources or an installation duly authorised under national law for the interim storage of sealed sources
duly completed application means the standard document that complies with all the requirements, as established in accordance with Article 17
agricultural products means products listed in Annex I to the Treaty, with the exception of fishery and aquaculture products covered by Regulation (EC) No 104/2000
processing of agricultural products means any operation on an agricultural product resulting in a product which is also an agricultural product, except on-farm activities necessary for preparing an animal or plant product for the first sale
marketing of agricultural products means holding or display with a view to sale, offering for sale, delivery or any other manner of placing on the market, except the first sale by a primary producer to resellers or processors and any activity preparing a product for such first sale; a sale by a primary producer to final consumers shall be considered as marketing if it takes place in separate premises reserved for that purpose
single undertaking includes, for the purposes of this Regulation, all enterprises having at least one of the following relationships with each other: (a) one enterprise has a majority of the shareholders’ or members’ voting rights in another enterprise; (b) one enterprise has the right to appoint or remove a majority of the members of the administrative, management or supervisory body of another enterprise; (c) one enterprise has the right to exercise a dominant influence over another enterprise pursuant to a contract entered into with that enterprise or to a provision in its memorandum or articles of association; (d) one enterprise, which is a shareholder in or member of another enterprise, controls alone, pursuant to an agreement with other shareholders in or members of that enterprise, a majority of shareholders’ or members’ voting rights in that enterprise.
Enterprises having any of the relationships referred to in points (a) to (d) of the first subparagraph through one or more other enterprises shall also be considered to be a single undertaking.
environmental protection means any action designed to remedy or prevent damage to physical surroundings or natural resources by a beneficiary’s own activities, to reduce the risk of such damage or to lead to more efficient use of natural resources, including energy-saving measures and the use of renewable sources of energy
energy-efficiency means an amount of saved energy determined by measuring and/or estimating consumption before and after implementation of an energy-efficiency improvement measure, whilst ensuring normalisation for external conditions that affect energy consumption
Union standard means (a) a mandatory Union standard setting the levels to be attained in environmental terms by individual undertakings, or (b) the obligation under Directive 2010/75/EU to use the best available techniques (‘BAT’) and ensure that emission levels of pollutants are not higher than they would be when applying BAT; for the cases where emission levels associated with the BAT have been defined in implementing acts adopted under Directive 2010/75/EU, those levels will be applicable for the purpose of these Guidelines; where those levels are expressed as a range, the limit where the BAT is first achieved will be applicable
eco-innovation means all forms of innovation activities resulting in or aimed at significantly improving environmental protection, including new production processes, new products or services, and new management and business methods, the use or implementation of which is likely to prevent or substantially reduce the risks for the environment, pollution and other negative impacts resulting from the use of resources, throughout the life cycle of related activities.
For the purposes of this definition, the following are not considered innovations: i. minor changes or improvements; ii. an increase in production or service capabilities through the addition of manufacturing or logistical systems which are very similar to those already in use; iii. changes in business practices, workplace organisation or external relations that are based on organisational methods already in use in the undertaking; iv. changes in management strategy; v. mergers and acquisitions; vi. ceasing to use a process; vii. simple capital replacement or extension; viii. changes resulting purely from changes in factor prices, customisation, regular seasonal and other cyclical changes; ix. trading of new or significantly improved products
renewable energy sources means the following renewable non-fossil energy sources: wind, solar, aerothermal, geothermal, hydrothermal and ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases
biomass means the biodegradable fraction of products, waste and residues from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as biogases and the biodegradable fraction of industrial and municipal waste
biofuel means liquid or gaseous fuel for transport produced from biomass
bioliquid means liquid fuel for energy purposes other than for transport, including electricity, and heating and cooling, produced from biomass
sustainable biofuel means a biofuel fulfilling the sustainability criteria set out in Article 17 of Directive 2009/28/EC of the European Parliament and of the Council on the promotion of the use of energy from renewable sources and any amendment thereof
cooperation mechanism means a mechanism which fulfils the conditions of Article 6, 7 or 8 of Directive 2009/28/EC
energy from renewable energy sources means energy produced by plants using only renewable energy sources, as well as the share in terms of calorific value of energy produced from renewable energy sources in hybrid plants which also use conventional energy sources and it includes renewable electricity used for filling storage systems, but excludes electricity produced as a result of storage systems
cogeneration or combined heat and power (CHP) means the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy
high-efficiency cogeneration means cogeneration which satisfies the definition of high-efficiency cogeneration as set out in Article 2(34) of Directive 2012/27/EU
energy-efficient district heating and cooling means district heating and cooling which satisfies the definition of efficient district heating and cooling system as set out in Article 2(41) and (42) of Directive 2012/27/EU. The definition includes the heating/cooling production plants and the network (including related facilities) necessary to distribute the heat/cooling from the production units to the customer premises
environmental tax means a tax with a specific tax base that has a clear negative effect on the environment or which seeks to tax certain activities, goods or services so that the environmental costs may be included in their price and/or so that producers and consumers are oriented towards activities which better respect the environment
Union minimum tax level means the minimum level of taxation provided for in Union legislation; for energy products and electricity it means the minimum level of taxation laid down in Annex I to Council Directive 2003/96/EC
small and medium-sized enterprise (SME) means an undertaking that fulfils the conditions laid down in the Commission recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises
‘large enterprise’ and ‘large undertaking’ mean enterprises which do not fall within the definition of SME
individual aid means aid granted either on the basis of a scheme or on an ad hoc basis
aid intensity means the gross aid amount expressed as a percentage of the eligible costs; all figures used must be taken before any deduction of tax or other charge, where aid is awarded in a form other than a grant, the aid amount must be the grant equivalent of the aid, aid payable in several installments must be calculated at its value at the moment of granting; the interest rate to be used for discounting purposes and for calculating the aid amount in a soft loan must be the reference rate applicable at the time of grant; the aid intensity is calculated per beneficiary
operating benefit means, for the purposes of calculating eligible costs, in particular cost savings or additional ancillary production directly linked to the extra investment for environmental protection and, where applicable, benefits accruing from other support measures whether or not they constitute State aid, including operating aid granted for the same eligible costs, feed-in tariffs or other support measures
operating cost means, for the purposes of calculating eligible costs, in particular additional production costs such as maintenance costs flowing from the extra investment for environmental protection
intangible asset means, for the purposes of calculating eligible costs, spending on technology transfer through the acquisition of operating licenses or of patented and non-patented know-how where such spending complies with the following conditions: (a) it must be regarded as a depreciable asset; (b) it must be purchased on market terms, from an undertaking in which the acquirer has no power of direct or indirect control; (c) it must be included in the assets of the undertaking, and remain in the establishment of the recipient of the aid and be used there for at least five years; this condition does not apply if the intangible asset is technically out of date; if it is sold during those five years, the yield from the sale must be deducted from the eligible costs and all or part of the amount of aid must, where appropriate, be reimbursed
tangible asset means, for the purposes of calculating eligible costs, investments in land which are strictly necessary in order to meet environmental objectives, investments in buildings, plant and equipment intended to reduce or eliminate pollution and nuisances, and investments to adapt production methods with a view to protecting the environment
internalise the costs means the principle that all costs associated with the protection of the environment should be included in the production costs of the polluting undertaking
polluter means someone who directly or indirectly damages the environment or who creates conditions leading to such damage
pollution means the damage caused by the polluter by directly or indirectly damaging the environment, or by creating conditions leading to such damage to physical surroundings or natural resources
the polluter pays principle or PPP means that the costs of measures to deal with pollution should be borne by the polluter who causes the pollution
contaminated site means a site where there is a confirmed presence, caused by man, of hazardous substances of such a level that they pose a significant risk to human health or the environment taking into account current and approved future use of the land
ad hoc aid means aid not granted on the basis of an aid scheme
energy infrastructure means any physical equipment or facility which is located within the Union or linking the Union to one or more third countries and falling under the following categories:
(a) concerning electricity: (i) infrastructure for transmission, as defined in Article 2(3) by Directive 2009/72/EC; (ii) infrastructure for distribution, as defined in Article 2(5) by Directive 2009/72/EC; (iii) electricity storage, defined as facilities used for storing electricity on a permanent or temporary basis in above-ground or underground infrastructure or geological sites, provided they are directly connected to high-voltage transmission lines designed for a voltage of 110 kV or more; (iv) any equipment or installation essential for the systems defined in points (i) to (iii) to operate safely, securely and efficiently, including protection, monitoring and control systems at all voltage levels and substations; and (v) smart grids, defined as any equipment, line, cable or installation, both at transmission and low and medium voltage distribution level, aiming at two-way digital communication, real-time or close to real-time, interactive and intelligent monitoring and management of electricity generation, transmission, distribution and consumption within an electricity network in view of developing a network efficiently integrating the behaviour and actions of all users connected to it — generators, consumers and those that do both — in order to ensure an economically efficient, sustainable electricity system with low losses and high quality and security of supply and safety;
(b) concerning gas: (i) transmission and distribution pipelines for the transport of natural gas and bio gas that form part of a network, excluding high-pressure pipelines used for upstream distribution of natural gas; (ii) underground storage facilities connected to the high-pressure gas pipelines mentioned in point (i); (iii) reception, storage and regasification or decompression facilities for liquefied natural gas (‘LNG’) or compressed natural gas (‘CNG’); and (iv) any equipment or installation essential for the system to operate safely, securely and efficiently or to enable bi- directional capacity, including compressor stations;
(c) concerning oil: (i) pipelines used to transport crude oil; (ii) pumping stations and storage facilities necessary for the operation of crude oil pipelines; and (iii) any equipment or installation essential for the system in question to operate properly, securely and efficiently, including protection, monitoring and control systems and reverse-flow devices;
(d) concerning CO2: networks of pipelines, including associated booster stations, for the transport of CO2 to storage sites, with the aim to inject the CO2 in suitable underground geological formations for permanent storage
funding gap means the difference between the positive and negative cash flows over the lifetime of the investment, discounted to their current value (typically using the cost of capital)
Carbon Capture and Storage or CCS means a set of technologies that captures the carbon dioxide (CO2) emitted from industrial plants based on fossil fuels or biomass, including power plants, transports it to a suitable storage site and injects the CO2 in suitable underground geological formations for the purpose of permanent storage of CO2
generation adequacy means a level of generated capacity which is deemed to be adequate to meet demand levels in the Member State in any given period, based on the use of a conventional statistical indicator used by organisations which the Union institutions recognise as performing an essential role in the creation of a single market in electricity, for example ENTSO-E
generator means an undertaking which produces electrical power for commercial purposes
generation adequacy measure means a mechanism which has the aim of ensuring that certain generation adequacy levels are met at national level
balancing responsibility means responsibility for deviations between generation, consumption and commercial transactions of a BRP within a given imbalance settlement period
standard balancing responsibilities mean non-discriminatory balancing responsibilities across technologies which do not exempt any generator from those responsibilities
balance responsible party (BRP) means a market participant or its chosen representative responsible for its imbalances
imbalances means deviations between generation, consumption and commercial transactions of a BRP within a given imbalance settlement period
imbalance Settlement means a financial settlement mechanism aiming at recovering the costs of balancing applicable to imbalances of BRPs
imbalance Settlement Period means time units used for computing BRPs’ imbalances
competitive bidding process means a non-discriminatory bidding process that provides for the participation of a sufficient number of undertakings and where the aid is granted on the basis of either the initial bid submitted by the bidder or a clearing price. In addition, the budget or volume related to the bidding process is a binding constraint leading to a situation where not all bidders can receive aid
start of works means either the start of construction works on the investment or the first firm commitment to order equipment or other commitment that makes the investment irreversible, whichever is the first in time. Buying of land and preparatory works such as obtaining permits and conducting preliminary feasibility studies are not considered as start of works. For take- overs, ‘start of works’ means the moment of acquiring the assets directly linked to the acquired establishment
demonstration project means a project demonstrating a technology as a first of its kind in the Union and representing a significant innovation that goes well beyond the state of the art
assisted areas means areas designated in an approved regional aid map for the period 1 July 2014 to 31 December 2020 in application of Articles 107(3)(a) and (c) of the Treaty
regional aid map means the list of areas designated by a Member State in accordance with the conditions laid down in the Guidelines on regional State aid for 2014-2020
fishing activity means searching for fish, shooting, setting, towing, hauling of a fishing gear, taking catch on board, transhipping, retaining on board, processing on board, transferring, caging, fattening and landing of fish and fisheries products
rules of the common fisheries policy means Union legislation on the conservation, management and exploitation of living aquatic resources, on aquaculture and on processing, transport and marketing of fisheries and aquaculture products
control means monitoring and surveillance
inspection means any check which is carried out by officials regarding compliance with the rules of the common fisheries policy and which is noted in an inspection report
surveillance means the observation of fishing activities on the basis of sightings by inspection vessels or official aircrafts and technical detection and identification methods
official means a person authorised by a national authority, the Commission or the Community Fisheries Control Agency to carry out an inspection
Union inspectors means officials of a Member State or of the Commission or the body designated by it, whose names are contained in the list established in accordance with Article 79
control observer means a person authorised by a national authority to observe the implementation of the rules of the common fisheries policy
fishing licence means an official document conferring on its holder the right, as determined by national rules, to use a certain fishing capacity for the commercial exploitation of living aquatic resources. It contains minimum requirements concerning the identification, technical characteristics and fitting out of a Union fishing vessel
fishing authorisation means a fishing authorisation issued in respect of a Union fishing vessel in addition to its fishing licence, entitling it to carry out specific fishing activities during a specified period, in a given area or for a given fishery under specific conditions
automatic identification system means an autonomous and continuous vessel identification and monitoring system which provides means for ships to electronically exchange with other nearby ships and authorities ashore ship data including identification, position, course and speed
vessel monitoring system data means data on the fishing vessel identification, geographical position, date, time, course and speed transmitted by satellite-tracking devices installed on board fishing vessels to the fisheries monitoring centre of the flag Member State
vessel detection system means a satellite based remote sensing technology which can identify vessels and detect their positions at sea
fishing restricted area means any marine area under the jurisdiction of a Member State which has been defined by the Council and where fishing activities are either limited or banned
fisheries monitoring centre means an operational centre established by a flag Member State and equipped with computer hardware and software enabling automatic data reception, processing and electronic data transmission
transhipment means the unloading of all or any fisheries or aquaculture products on board a vessel to another vessel
risk means the likelihood of an event that may occur and would constitute a violation of the rules of the common fisheries policy
risk management means the systematic identification of risks and the implementation of all measures necessary for limiting the occurrence of these risks. This includes activities such as collecting data and information, analysing and assessing risks, preparing and taking action, and regular monitoring and review of the process and its outcomes, based on international, Union and national sources and strategies
operator means the natural or legal person who operates or holds any undertaking carrying out any of the activities related to any stage of production, processing, marketing, distribution and retail chains of fisheries and aquaculture products
lot means a quantity of fisheries and aquaculture products of a given species of the same presentation and coming from the same relevant geographical area and the same fishing vessel, or group of fishing vessels, or the same aquaculture production unit
processing means the process by which the presentation was prepared. It includes filleting, packing, canning, freezing, smoking, salting, cooking, pickling, drying or preparing fish for market in any other manner
landing means the initial unloading of any quantity of fisheries products from on board a fishing vessel to land
retail means the handling and/or processing of products of living aquatic resources and their storage at the point of sale or delivery to the final consumer, and includes distribution
multiannual plans means recovery plans as referred to in Article 5 of Regulation (EC) No 2371/2002, management plans as referred to in Article 6 of Regulation (EC) No 2371/2002 as well as other Union provisions adopted on the basis of Article 37 of the Treaty and providing for specific management measures for particular fish stocks for several years
coastal State means the State in the waters under the sovereignty or jurisdiction or in the ports of which an activity takes place
enforcement means any actions taken to ensure compliance with the rules of the common fisheries policy
certified engine power means the maximum continuous engine power which can be obtained at the output flange of an engine according to the certificate issued by the Member State’s authorities or classification societies or other operators assigned by them
recreational fisheries means non-commercial fishing activities exploiting marine living aquatic resources for recreation, tourism or sport
relocation means fishing operations where the catch or part thereof is transferred or moved from shared fishing gear to a vessel or from a fishing vessel’s hold or its fishing gear to a keep net, container or cage outside the vessel in which the live catch is kept until landing
relevant geographical area means a sea area that is considered as a unit for the purposes of geographical classification in fisheries expressed by reference to a FAO sub-area, division or sub-division, or where applicable an ICES statistical rectangle, fishing effort zone, economic zone or area bounded by geographical coordinates
fishing vessel means any vessel equipped for commercial exploitation of living aquatic resources
fishing opportunity means a quantified legal entitlement to fish, expressed in terms of catches and/or fishing effort
household tumble drier means an appliance in which textiles are dried by tumbling in a rotating drum through which heated air is passed and which is designed to be used principally for non-professional purposes
built-in household tumble drier means a household tumble drier intended to be installed in a cabinet, a prepared recess in a wall or a similar location, requiring furniture finishing
household combined washer-drier means a household washing machine which includes both a spin extraction function and also a means for drying the textiles, usually by heating and tumbling
household spin-extractor’ also known commercially as ‘spin-drier’ means an appliance in which water is removed from the textiles by centrifugal action in a rotating drum and drained through an automatic pump and which is designed to be used principally for non-professional purposes
air-vented tumble drier means a tumble drier that draws in fresh air, passes it over the textiles and vents the resulting moist air into the room or outside
condenser tumble drier means a tumble drier which includes a device (either using condensation or any other means) for removing moisture from the air used for the drying process
automatic tumble drier means a tumble drier which switches off the drying process when a certain moisture content of the load is detected, for example through conductivity or temperature sensing
non-automatic tumble drier means a tumble drier which switches off the drying process after a predefined period, usually controlled by a timer, but which may also be manually switched off
programme means a series of operations that are predefined and which are declared by the manufacturer as suitable for drying certain types of textile
cycle means a complete drying process, as defined for the selected programme
programme time means the time that elapses from the initiation of the programme until the completion of the programme, excluding any end-user programmed delay
rated capacity means the maximum mass in kilograms, indicated by the manufacturer in 0,5 kilogram increments of dry textiles of a particular type, which can be treated in a household tumble drier with the selected programme, when loaded in accordance with the manufacturer’s instructions
partial load means half of the rated capacity of a household tumble drier for a given programme
condensation efficiency means the ratio between the mass of moisture condensed by a condenser tumble drier and the mass of moisture removed from the load at the end of a cycle
off-mode means a condition where the household tumble drier is switched off using appliance controls or switches accessible to and intended for operation by the end-user during normal use to attain the lowest power consumption that may persist for an indefinite time while the household tumble drier is connected to a power source and used in accordance with the manufacturer’s instructions; where there is no control or switch accessible to the end-user, ‘off-mode’ means the condition reached after the household tumble drier reverts to a steady-state power consumption on its own
left-on mode means the lowest power consumption mode that may persist for an indefinite time after completion of the programme without any further intervention by the end-user besides unloading of the household tumble drier
equivalent household tumble drier means a model of household tumble drier placed on the market with the same rated capacity, technical and performance characteristics, energy consumption, condensation efficiency where relevant, standard cotton programme time and airborne acoustical noise emissions during drying as another model of household tumble drier placed on the market under a different commercial code number by the same manufacturer
standard cotton programme means the cycle which dries cotton laundry with an initial moisture content of the load of 60% up to a remaining moisture content of the load of 0%
computer means a device which performs logical operations and processes data, is capable of using input devices and outputting information to a display, and normally includes a central processing unit (CPU) to perform operations. If no CPU is present, then the device must function as a client gateway to a computer server which acts as a computational processing unit
computer server means a computing product that provides services and manages networked resources for client devices, such as desktop computers, notebook computers, desktop thin clients, internet protocol (IP) telephones, or other computer servers. A computer server is typically placed on the market for use in data centres and office/corporate environments. A computer server is primarily accessed via network connections, and not through direct user input devices, such as a keyboard or a mouse
A computer server has the following characteristics: (a) is designed to support computer server operating systems (OS) and/or hypervisors, and targeted to run user-installed enterprise applications; (b) supports error-correcting code (ECC) and/or buffered memory (including both buffered dual in-line memory modules (DIMMs) and buffered on board (BOB) configurations); (c) is placed on the market with one or more AC-DC power supply(ies); (d) all processors have access to shared system memory and are independently visible to a single OS or hypervisor
external power supply means a device which has the following characteristics: (a) is designed to convert alternating current (AC) power input from the mains power source input into lower voltage direct current (DC) or AC output; (b) is able to convert to only one DC or AC output voltage at a time; (c) is intended to be used with a separate device that constitutes the primary load; (d) is contained in a physical enclosure separate from the device that constitutes the primary load; (e) is connected to the device that constitutes the primary load via a removable or hard-wired male/female electrical connection, cable, cord or other wiring; (f) has nameplate output power not exceeding 250 Watts
internal power supply means a component designed to convert AC voltage from the mains to DC voltage(s) for the purpose of powering the computer or computer server and has the following characteristics: (a) is contained within the computer or computer server casing but is separate from the main computer or computer server board; (b) the power supply connects to the mains through a single cable with no intermediate circuitry between the power supply and the mains power; and (c) all power connections from the power supply to the computer or computer server components, with the exception of a DC connection to a display in an integrated desktop computer, are internal to the computer casing.
Internal DC-to-DC converters used to convert a single DC voltage from an external power supply into multiple voltages for use by a computer or computer server are not considered internal power supplies
desktop computer means a computer where the main unit is intended to be located in a permanent location and is not designed for portability and which is designed for use with an external display and external peripherals such as a keyboard and mouse.
The following categories of desktop computers are defined for the purposes of this Regulation: (a) ‘Category A’ desktop computer means a desktop computer that does not meet the definition of Category B, Category C or Category D desktop computer; (b) ‘Category B’ desktop computer means a desktop computer with: (i) two physical cores within the CPU; and (ii) a minimum of two gigabytes (GB) of system memory; (c) ‘Category C’ desktop computer means a desktop computer with: (i) three or more physical cores within the CPU; and (ii) a configuration of a minimum of one of the following two characteristics: a minimum of two gigabytes (GB) of system memory, and/or a discrete graphics card (dGfx); (d) ‘Category D’ desktop computer means a desktop computer with: (i) a minimum four physical cores in the CPU; and (ii) a configuration of a minimum of one of the following two characteristics: a minimum of four gigabytes (GB) of system memory, and/or a discrete graphics card (dGfx) meeting the G3 (with FB Data Width > 128-bit), G4, G5, G6 or G7 classification
integrated desktop computer means a computer in which the computer and the display function as a single unit, which receives its AC power through a single cable. Integrated desktop computers come in one of two possible forms: (1) a product where the display and the computer are physically combined into a single unit; or (2) a product where the display is separated from the computer but it is connected to the main chassis by a direct current (DC) power cord. An integrated desktop computer is intended to be located in a permanent location and is not designed for portability. Integrated desktop computers are not primarily designed for the display and reception of audiovisual signals.
The following categories of integrated desktop computers are defined for the purposes of this Regulation: (a) ‘Category A’ integrated desktop computer means an integrated desktop computer that does not meet the definition of Category B, Category C or Category D integrated desktop computer; (b) ‘Category B’ integrated desktop computer means an integrated desktop computer with: (i) two physical cores in the CPU; and (ii) a minimum of two gigabytes (GB) of system memory; (c) ‘Category C’ integrated desktop computer means an integrated desktop computer with: (i) three or more physical cores in the CPU; and (ii) a configuration of a minimum of one of the following two characteristics: a minimum of two gigabytes (GB) of system memory, and/or a discrete graphics card (dGfx); (d) ‘Category D’ integrated desktop computer means an integrated desktop computer with: (i) a minimum of four physical cores in the CPU; and (ii) a configuration of a minimum of one of the following two characteristics: a minimum of four gigabytes (GB) of system memory, and/or a discrete graphics card (dGfx) meeting the G3 (with FB Data Width > 128-bit), G4, G5, G6 or G7 classification
notebook computer means a computer designed specifically for portability and to be operated for extended periods of time either with or without a direct connection to an AC power source. Notebook computers utilise an integrated display, with a viewable diagonal screen size of at least 22,86 cm (9 inches), and are capable of operation on an integrated battery or other portable power source.
Notebook computers also include the following subtypes: (a) ‘Tablet computer’ means a product which is a type of notebook computer that includes both an attached touch-sensitive display and an attached physical keyboard; (b) ‘Slate computer’ means a type of notebook computer that includes an integrated touch-sensitive display but does not have a permanently attached physical keyboard; (c) ‘Mobile thin client’ means a type of notebook computer that relies on a connection to remote computing resources (e.g. computer server, remote workstation) to obtain primary functionality and has no rotational storage media integral to the product.
The following categories of notebook computers are defined for the purposes of this Regulation: (a) ‘Category A’ notebook computer means a notebook computer that does not meet the definition of Category B or Category C notebook computer; (b) ‘Category B’ notebook computer means a notebook computer with at least one discrete graphics card (dGfx); (c) ‘Category C’ notebook computer means a notebook computer with at least the following characteristics: (a) a minimum two physical cores in the CPU; (b) a minimum two gigabytes (GB) of system memory; and (c) a discrete graphics card (dGfx) meeting the G3 (with FB Data Width > 128-bit), G4, G5, G6 or G7 classification
Products that would otherwise meet the definition of notebook computer but have idle state power demand of less than 6 W are not considered to be notebook computers for the purposes of this Regulation
desktop thin client means a computer that relies on a connection to remote computing resources (e.g. computer server, remote workstation) to obtain primary functionality and has no rotational storage media integral to the product. The main unit of a desktop thin client must be intended for use in a permanent location (e.g. on a desk) and not for portability. Desktop thin clients can output information to either an external or, where included with the product, an internal display
workstation means a high-performance, single-user computer primarily used for graphics, Computer Aided Design, software development, financial and scientific applications among other compute intensive tasks, and which has the following characteristics: (a) has a mean time between failures (MTBF) of at least 15 000 hours; (b) has error-correcting code (ECC) and/or buffered memory; (c) meets three of the following five characteristics: (1) has supplemental power support for high-end graphics (i.e. peripheral component interconnect (PCI)-E 6-pin 12 V supplemental power feed); (2) its system is wired for greater than x4 PCI-E on the motherboard in addition to the graphics slot(s) and/or PCI-X support; (3) does not support uniform memory access (UMA) graphics; (4) includes five or more PCI, PCI-E or PCI-X slots; (5) is capable of multi-processor support for two or more CPU (must support physically separate CPU packages/sockets, i.e. not met with support for a single multi core CPU)
mobile workstation means a high-performance, single-user computer primarily used for graphics, Computer Aided Design, software development, financial and scientific applications among other compute intensive tasks, excluding game play, and which is designed specifically for portability and to be operated for extended periods of time either with or without a direct connection to an AC power source. Mobile workstations utilise an integrated display and are capable of operation on an integrated battery or other portable power source. Most mobile workstations use an external power supply and most have an integrated keyboard and pointing device. A mobile workstation has the following characteristics: (a) has a mean time between failures (MTBF) of at least 13 000 hours; (b) has at least one discrete graphics card (dGfx) meeting the G3 (with FB Data Width > 128-bit), G4, G5, G6 or G7 classification; (c) supports the inclusion of three or more internal storage devices; (d) supports at least 32 GB of system memory
small-scale server means a type of computer that typically uses desktop computer components in a desktop form factor but is designed primarily to be a storage host for other computers and to perform functions such as providing network infrastructure services and hosting data/media, and which has the following characteristics: (a) is designed in a pedestal, tower, or other form factor similar to those of desktop computers such that all data processing, storage, and network interfacing is contained within one box; (b) is designed to be operational 24 hours per day and 7 days per week; (c) is primarily designed to operate in a simultaneous multi-user environment serving several users through networked client units; (d) where placed on the market with an operating system, the operating system is designed for home server or low-end server applications; (e) is not placed on the market with a discrete graphics card (dGfx) meeting any classification other than G1
blade system and components means a system composed of an enclosure (‘blade chassis’) into which different types of blade storage and servers are inserted. The enclosure provides shared resources on which the servers and storage are dependent. Blade systems are designed as a scalable solution to combine multiple computer servers or storage units in a single enclosure, and are designed for technicians to be able to easily add or replace (hot-swap) blades (e.g. blade servers) in the field
server appliance means a computer server bundled with a pre-installed operating system and application software that is used to perform a dedicated function or set of tightly coupled functions. A server appliance delivers services through one or more networks, and is typically managed through a web or command line interface. Server appliance hardware and software configurations are customised by a vendor to perform a specific task, including network or storage, and are not intended to execute user-supplied software
multi-node server means a system composed of an enclosure where two or more independent computer servers (or nodes) are inserted, which share one or more power supplies. The combined power for all nodes is distributed through the shared power supply(ies). A multi-node server is designed and built as a single enclosure and is not designed to be hot-swappable
dual-node server means a common multi-node server configuration consisting of two server nodes
computer server with more than four processor sockets means a computer server containing more than four interfaces designed for the installation of a processor
game console means a mains-powered standalone device which is designed to provide video game playing as its primary function. A game console is typically designed to provide output to an external display as the main game-play display. Game consoles typically include a CPU, system memory and a graphics processing unit(s) (GPU), and may contain hard drives or other internal storage options, and optical drives. Game consoles typically utilise handheld controllers or other interactive controllers as their primary input device rather than an external keyboard or mouse. Game consoles do not typically include conventional personal computing operating systems but instead utilise console-specific operating systems. Handheld gaming devices, with an integrated display as the primary game-play display, and which primarily operate on an integrated battery or other portable power source rather than via a direct connection to an AC power source, are considered to be a type of game console
docking station means a discrete product designed to be connected to a computer in order to perform functions such as expanding connectivity or consolidating connections to peripheral devices. Docking stations may also facilitate charging of internal batteries in the connected computer
Central Processing Unit (CPU) means a component in a computer that controls the interpretation and execution of instructions. CPUs may contain one or more physical processors known as ‘execution cores’. An execution core means a processor that is physically present. Additional ‘virtual’ or ‘logical’ processors derived from one or more than one execution core are not physical cores. More than one execution core may be contained in a processor package occupying a single CPU physical socket. The total number of execution cores in the CPU is the sum of the execution cores provided by the devices connected to all the CPU physical sockets
Discrete Graphics Card (dGfx) means a discrete internal component containing one or more graphics processing units (GPUs) with a local memory controller interface and local graphics-specific memory and falling into one of the following categories: (a) G1 (FB_BW ≤ 16); (b) G2 (16 < FB_BW ≤ 32); (c) G3 (32 128 (with FB Data Width < 192-bit)); (g) G7 (FB_BW > 128 (with FB Data Width ≥ 192-bit));
‘Frame buffer bandwidth’ (FB _BW) means the amount of data that is processed per second by all GPUs on a dGfx, which is calculated using the following formula: [ФОРМУЛА 1] Where: (a) frame buffer bandwidth is expressed in GigaBytes/second (GB/s); (b) data rate is the effective memory data frequency in MHz; (c) data width is the memory frame buffer (FB) data width, expressed in bits (b); (d) ‘8’ converts the calculation into Bytes; (e) dividing by 1 000 converts Mega into Giga
internal storage means a component internal to the computer which provides non-volatile storage of data
product type means desktop computer, integrated desktop computer, notebook computer, desktop thin client, workstation, mobile workstation, small-scale server, computer server, blade system and components, multi-node server, server appliance, game console, docking station, internal power supply or external power supply
display sleep mode means the power mode the display product enters after receiving a signal from a connected device or an internal stimulus (such as a timer or occupancy sensor). The display product may also enter this mode by virtue of a signal produced by user input. The product must wake on receiving a signal from a connected device, a network, a remote control, and/or an internal stimulus. While the product is in this mode, it is not producing a visible picture, with the possible exception of user-oriented or protective functions such as product information or status displays, or sensor-based functions
annual total energy consumption (ETEC) means the electricity consumed by a product over specified periods of time across defined power modes and states
off mode means the power demand level in the low power mode which cannot be switched off (influenced) by a user, other than through the movement of a mechanical switch, and which may persist for an indefinite period of time when the appliance is connected to the main electricity supply and used in accordance with the manufacturer’s instructions. Where Advanced Configuration and Power Interface (ACPI) standards are applicable, off mode usually correlates to ACPI system level G2/S5 (‘soft off’) state.
‘Poff’ represents off mode power in Watts as measured according to the procedures indicated in Annex II
lowest power state means the state or mode with the lowest power demand found in a computer. This state or mode may be entered or left by either a mechanical means (e.g. by turning off the computer’s power through the movement of a mechanical switch) or via automatic means
sleep mode means a low power mode that a computer is capable of entering automatically after a period of inactivity or by manual selection. In this mode the computer will respond to a wake event. Where Advanced Configuration and Power Interface (ACPI) standards are applicable, sleep mode usually correlates to ACPI system level G1/S3 (suspend to RAM) state.
‘Psleep’ represents sleep mode power in Watts as measured according to the procedures indicated in Annex II
idle state means a state of a computer in which the operating system and other software have completed loading, a user profile has been created, the computer is not in sleep mode, and activity is limited to those basic applications that the operating system starts by default
‘Pidle’ represents idle state power in Watts as measured according to the procedures indicated in Annex II
Additional Internal Storage means any and all internal storage devices, including hard disk drives (HDD), solid state drives (SSD) and hybrid hard drives (HHD), included within a computer beyond the first
television tuner means a discrete internal component that allows a computer to receive television signals
audio card (sound card) means a discrete internal component that processes input and output audio signals to and from a computer
wake event means a user, scheduled, or external event or stimulus that causes the computer to transition from sleep mode or off mode to an active mode of operation. Wake event includes, but is not limited to, the following events: (i) movement of the mouse; (ii) keyboard activity; (iii) controller input; (iv) real-time clock event; (v) a button press on the chassis; and (vi) in the case of external events, stimulus conveyed via a remote control, network or modem
active mode means the state in which a computer is carrying out useful work in response to (a) prior or concurrent user input or (b) a prior or concurrent instruction over the network. This state includes active processing, seeking data from storage, memory or cache, including idle state time while awaiting further user input and before entering low power modes
Wake On LAN (WOL) means a functionality which allows a computer to transition from sleep mode or off mode (or another similar low power mode) when directed by a network request via Ethernet
UMA means uniform memory access
information or status display means a continuous function providing information or indicating the status of the computer on a display, including clocks
vacuum cleaner means an appliance that removes soil from a surface to be cleaned by means of an airflow created by underpressure developed within the unit
hybrid vacuum cleaner means a vacuum cleaner that can be powered by both electric mains and batteries
wet vacuum cleaner means a vacuum cleaner that removes dry and/or wet material (soil) from the surface by applying water-based detergent or steam to the surface to be cleaned, and removing it, and the soil by an airflow created by underpressure developed within the unit, including types commonly known as spray-extraction vacuum cleaners
wet and dry vacuum cleaner means a vacuum cleaner designed to remove a volume of more than 2,5 litres, of liquid, in combination with the functionality of a dry vacuum cleaner
dry vacuum cleaner means a vacuum cleaner designed to remove soil that is principally dry (dust, fibre, threads), including types equipped with a battery operated active nozzle
battery operated active nozzle means a cleaning head provided with an agitation device powered by batteries to assist dirt removal
battery operated vacuum cleaner means a vacuum cleaner powered only by batteries
robot vacuum cleaner means a battery operated vacuum cleaner that is capable of operating without human intervention within a defined perimeter, consisting of a mobile part and a docking station and/or other accessories to assist its operation
industrial vacuum cleaner means a vacuum cleaner designed to be part of a production process, designed for removing hazardous material, designed for removing heavy dust from building, foundry, mining or food industry, part of an industrial machine or tool and/or a commercial vacuum cleaner with a head width exceeding 0,50 m
commercial vacuum cleaner means a vacuum cleaner for professional housekeeping purposes and intended to be used by laymen, cleaning staff or contracting cleaners in office, shop, hospital and hotel environments, declared by the manufacturer as such in the Declaration of Conformity pertaining to the Directive 2006/42/EC of the European Parliament and of the Council
central vacuum cleaner means a vacuum cleaner with a fixed (not movable) underpressure source location and the hose connections located at fixed positions in the building
floor polisher means an electrical appliance that is designed to protect, smoothen and/or render shiny certain types of floors, usually operated in combination with a polishing means to be rubbed on the floor by the appliance and commonly also equipped with the auxiliary functionality of a vacuum cleaner
outdoor vacuum means an appliance that is designed for use outdoors to collect debris such as grass clippings and leaves into a collector by means of an airflow created by underpressure developed within the unit and which may contain a shredding device and may also be able to perform as a blower
full size battery operated vacuum cleaner means a battery operated vacuum cleaner which when fully charged, can clean 15 m2 of floor area by applying 2 double strokes to each part of the floor without recharge
water filter vacuum cleaner means a dry vacuum cleaner that uses more than 0,5 litre of water as the main filter medium, whereby the suction air is forced through the water entrapping the removed dry material as it passes through
household vacuum cleaner means a vacuum cleaner intended for household or domestic use, declared by the manufacturer as such in the Declaration of Conformity pertaining to Directive 2006/95/EC of the European Parliament and of the Council
general purpose vacuum cleaner means a vacuum cleaner supplied with a fixed or at least one detachable nozzle designed for cleaning both carpets and hard floors, or supplied with both at least one detachable nozzle designed specifically for cleaning carpets and at least one detachable nozzle for cleaning hard floors
hard floor vacuum cleaner means a vacuum cleaner supplied with a fixed nozzle designed specifically for cleaning hard floors, or supplied solely with one or more detachable nozzles designed specifically for cleaning hard floors
carpet vacuum cleaner means a vacuum cleaner supplied with a fixed nozzle designed specifically for cleaning carpets, or supplied solely with one or more detachable nozzles designed specifically for cleaning carpets
equivalent vacuum cleaner means a model of vacuum cleaner placed on the market with the same input power, annual energy consumption, dust pick up on carpet and hard floor, dust re-emission, sound power level, hose durability and operational motor lifetime as another model of vacuum cleaner placed on the market under a different commercial code number by the same manufacturer
hard floor test means a test of two cleaning cycles where the cleaning head of a vacuum cleaner operating at maximum suction setting passes over a wooden test plate test area with width equal to the cleaning head width and appropriate length, featuring a diagonally (45°) placed test crevice, where the time elapsed, electric power consumption and the relative position of the centre of the cleaning head to the test area are continuously measured and recorded at an appropriate sample rate and where at the end of each cleaning cycle the mass decrease of the test crevice is appropriately assessed
test crevice means a removable U-shaped insert with appropriate dimensions filled at the beginning of a cleaning cycle with appropriate artificial dust
carpet test means a test with an appropriate number of cleaning cycles on a Wilton carpet test rig where the cleaning head of a vacuum cleaner operating at maximum suction setting passes over the test area with width equal to the cleaning head width and appropriate length, soiled with equally distributed and appropriately embedded test dust of appropriate composition, where the time elapsed, electric power consumption and the relative position of the centre of the cleaning head to the test area are continuously measured and recorded at an appropriate sample rate and at the end of each cleaning cycle the mass increase of the appliance dust receptacle is appropriately assessed
cleaning head width in m, at an accuracy of 3 decimal places, means the external maximum width of the cleaning head
cleaning cycle means a sequence of 5 double strokes of the vacuum cleaner on a floor-specific test area (‘carpet’ or ‘hard floor’)
double stroke means one forward and one backward movement of the cleaning head in a parallel pattern, performed at a uniform test stroke speed and with a specified test stroke length
test stroke speed in m/h means the appropriate cleaning head speed for testing, preferably realized with an electromechanical operator. Products with self-propelled cleaning heads shall try to come as close as possible to the appropriate speed, but a deviation is permitted when clearly stated in the technical documentation
test stroke length in m means the length of the test area plus the cleaning head distance covered by the centre of the cleaning head when moving over the appropriate acceleration zones before and after the test area
dust pick up (dpu) at an accuracy of 3 decimal places, means the ratio of the mass of the artificial dust removed, determined for carpet through the mass increase of the appliance dust receptacle and for hard floor through the mass decrease of the test crevice, after a number of double strokes of the cleaning head to the mass of artificial dust initially applied to a test area, for carpet corrected for the specific test conditions and for hard floor corrected for the length and positioning of the test crevice
reference vacuum cleaner system means electrically operated laboratory equipment used to measure the calibrated and reference dust pick-up on carpets with given air related parameters to improve the reproducibility of test results
rated input power in W means the electric input power declared by the manufacturer, whereby for appliances that are enabled to function also for other purposes than vacuum cleaning only the electric input power relevant to vacuum cleaning applies
dust re-emission means the ratio, expressed as a percentage at an accuracy of 2 decimal places, of the number of all dust particles of a size from 0,3 to 10 μm emitted by a vacuum cleaner to the number of all dust particles of the same size range entering the suction inlet when fed with a specific amount of dust of that particle size range. The value includes not only dust measured at the vacuum cleaner outlet but also dust emitted elsewhere either from leaks, or generated by the vacuum cleaner
sound power level means airborne acoustical noise emissions, expressed in dB(A) re 1 pW and rounded to the nearest integer
case definition means a set of commonly agreed diagnostic criteria that have to be fulfilled in order to accurately identify cases of a targeted serious cross-border threat to health in a given population, while excluding the detection of unrelated threats
communicable disease means an infectious disease caused by a contagious agent which is transmitted from person to person by direct contact with an infected individual or by indirect means such as exposure to a vector, animal, fomite, product or environment, or exchange of fluid, which is contaminated with the contagious agent
contact tracing means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a disease
epidemiological surveillance means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues
monitoring means the continuous observation, detection or review of changes in a condition, in a situation, or in activities, including a continuous function that uses systematic collection of data and analysis on specified indicators relating to serious cross-border threats to health
public health measure means a decision or an action which is aimed at preventing, monitoring or controlling the spread of diseases or contamination, combating severe risks to public health or mitigating their impact on public health
serious cross-border threat to health means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection
establishment means the whole location under the control of an operator where dangerous substances are present in one or more installations, including common or related infrastructures or activities; establishments are either lower-tier establishments or upper-tier establishments
lower-tier establishment means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 2 of Part 1 or in Column 2 of Part 2 of Annex I, but less than the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, where applicable using the summation rule laid down in note 4 to Annex I
upper-tier establishment means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, where applicable using the summation rule laid down in note 4 to Annex I
neighbouring establishment means an establishment that is located in such proximity to another establishment so as to increase the risk or consequences of a major accident
new establishment means (a) an establishment that enters into operation or is constructed, on or after 1 June 2015; or (b) a site of operation that falls within the scope of this Directive, or a lower-tier establishment that becomes an upper-tier establishment or vice versa, on or after 1 June 2015 due to modifications to its installations or activities resulting in a change in its inventory of dangerous substances
existing establishment means an establishment that on 31 May 2015 falls within the scope of Directive 96/82/EC and from 1 June 2015 falls within the scope of this Directive without changing its classification as a lower-tier establishment or upper-tier establishment
other establishment means a site of operation that falls within the scope of this Directive, or a lower-tier establishment that becomes an upper-tier establishment or vice versa, on or after 1 June 2015 for reasons other than those referred to in point 5
installation means a technical unit within an establishment and whether at or below ground level, in which dangerous substances are produced, used, handled or stored; it includes all the equipment, structures, pipework, machinery, tools, private railway sidings, docks, unloading quays serving the installation, jetties, warehouses or similar structures, floating or otherwise, necessary for the operation of that installation
operator means any natural or legal person who operates or controls an establishment or installation or, where provided for by national legislation, to whom the decisive economic or decision-making power over the technical functioning of the establishment or installation has been delegated
dangerous substance means a substance or mixture covered by Part 1 or listed in Part 2 of Annex I, including in the form of a raw material, product, by-product, residue or intermediate
mixture means a mixture or solution composed of two or more substances
presence of dangerous substances means the actual or anticipated presence of dangerous substances in the establishment, or of dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes, including storage activities, in any installation within the establishment, in quantities equal to or exceeding the qualifying quantities set out in Part 1 or Part 2 of Annex I
major accident means an occurrence such as a major emission, fire, or explosion resulting from uncontrolled developments in the course of the operation of any establishment covered by this Directive, and leading to serious danger to human health or the environment, immediate or delayed, inside or outside the establishment, and involving one or more dangerous substances
hazard means the intrinsic property of a dangerous substance or physical situation, with a potential for creating damage to human health or the environment
risk means the likelihood of a specific effect occurring within a specified period or in specified circumstances
storage means the presence of a quantity of dangerous substances for the purposes of warehousing, depositing in safe custody or keeping in stock
the public means one or more natural or legal persons and, in accordance with national law or practice, their associations, organisations or groups
the public concerned means the public affected or likely to be affected by, or having an interest in, the taking of a decision on any of the matters covered by Article 15(1); for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any applicable requirements under national law shall be deemed to have an interest
inspection means all actions, including site visits, checks of internal measures, systems and reports and follow-up documents, and any necessary follow-up, undertaken by or on behalf of the competent authority to check and promote compliance of establishments with the requirements of this Directive
marine equipment means equipment falling within the scope of this Directive in accordance with Article 3
EU ship means a ship flying the flag of a Member State and falling within the scope of the international conventions
international conventions means the following conventions, together with their protocols and codes of mandatory application, adopted under the auspices of the International Maritime Organization (IMO), which have entered into force and which lay down specific requirements for the approval by the flag State of equipment to be placed on board ships: the 1972 Convention on the International Regulations for Preventing Collisions at Sea (Colreg), the 1973 International Convention for the Prevention of Pollution from Ships (Marpol), the 1974 International Convention for the Safety of Life at Sea (Solas)
testing standards means the testing standards for marine equipment set by: the International Maritime Organization (IMO), the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (Cenelec), the International Telecommunication Union (ITU), the European Telecommunications Standards Institute (ETSI), the Commission, in accordance with Article 8 and Article 27(6) of this Directive, the regulatory authorities recognised in the mutual recognition agreements to which the Union is a party
international instruments means the international conventions, together with the resolutions and circulars of the IMO giving effect to those conventions in their up-to-date version, and the testing standards
wheel mark means the symbol referred to in Article 9 and set out in Annex I or, as appropriate, the electronic tag referred to in Article 11
notified body means an organisation designated by the competent national administration of a Member State in accordance with Article 17
making available on the market means any supply of marine equipment on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of marine equipment on the Union market
manufacturer means any natural or legal person who manufactures marine equipment or has marine equipment designed or manufactured, and markets that equipment under its name or trademark
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places marine equipment from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes marine equipment available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process carried out by the notified bodies, in accordance with Article 15, demonstrating whether marine equipment complies with the requirements laid down in this Directive
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of marine equipment that has already been placed on board EU ships or purchased with the intention of being placed on board EU ships
withdrawal means any measure aimed at preventing marine equipment in the supply chain from being made available on the market
EU declaration of conformity means a statement issued by the manufacturer in accordance with Article 16
продукт означає будь-яку позицію суднового обладнання
licence means an electronic or paper document with a specific period of validity, expressing the right and obligation to import or export products
notice on import and export licences for agricultural products means the detailed provisions for the import licence or export licence and set of information to be mentioned in a licence application and in a licence as published in the Official Journal of the European Union, C-series
making available on the market means any supply of a vessel for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a vessel on the Union market
manufacturer means any natural or legal person who manufactures a vessel or has a vessel designed or manufactured, and markets that vessel under his name or trade mark
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places a vessel from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a vessel available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
technical specification means a document that prescribes technical requirements to be fulfilled by a vessel
harmonised standard means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
орган з оцінювання відповідності означає орган, який виконує діяльність з оцінювання відповідності, у тому числі калібрування, випробування, сертифікацію та інспектування
conformity assessment means the process demonstrating whether the essential safety requirements of this Directive relating to a vessel have been fulfilled
recall means any measure aimed at achieving the return of a vessel that has already been made available to the end-user
withdrawal means any measure aimed at preventing a vessel in the supply chain from being made available on the market
CE marking means a marking by which the manufacturer indicates that the vessel is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
capital commitment means the contractual commitment of an investor to provide the alternative investment fund (AIF) with an agreed amount of investment on request by the AIFM
relevant person in relation to an AIFM means any of the following: (a) a director, partner or equivalent, or manager of the AIFM; (b) an employee of the AIFM, or any other natural person whose services are placed at the disposal and under the control of the AIFM and who is involved in the provision of collective portfolio management services by the AIFM; (c) a natural or legal person who is directly involved in the provision of services to the AIFM under a delegation arrangement to third parties for the purpose of the provision of collective portfolio management by the AIFM
senior management means the person or persons who effectively conduct the business of an AIFM in accordance with Article 8(1)(c) of Directive 2011/61/EU and, as the case may be, the executive member or members of the governing body
governing body means the body with ultimate decision making authority in an AIFM, comprising the supervisory and the managerial functions, or only the managerial function if the two functions are separated
special arrangement means an arrangement that arises as a direct consequence of the illiquid nature of the assets of an AIF which impacts the specific redemption rights of investors in a type of units or shares of the AIF and which is a bespoke or separate arrangement from the general redemption rights of investors
lighting means the application of light to a scene, objects or their surroundings so that they may be seen by humans
accent lighting means a form of lighting where light is directed so as to highlight an object or a part of an area
electrical lighting product means a product designed for use with electricity and intended for use in lighting
special purpose product means a product that uses the technologies covered by this Regulation but is intended for use in special applications because of its technical parameters as described in the technical documentation. Special applications are those that require technical parameters not necessary for the purposes of lighting average scenes or objects in average circumstances. These applications are of the following types:
(a) applications where the primary purpose of the light is not lighting, such as (i) emission of light as an agent in chemical or biological processes (such as polymerisation, ultraviolet light used for curing/drying/hardening, photodynamic therapy, horticulture, pet care, anti-insect products); (ii) image capture and image projection (such as camera flashlights, photocopiers, video projectors); (iii) heating (infrared lamps); (iv) signalling (such as traffic control or airfield lamps);
(b) lighting applications where (i) the spectral distribution of the light is intended to change the appearance of the scene or object lit, in addition to making it visible (such as food display lighting or coloured lamps as defined in point 1 of Annex I), with the exception of variations in correlated colour temperature; or (ii) the spectral distribution of the light is adjusted to the specific needs of particular technical equipment, in addition to making the scene or object visible for humans (such as studio lighting, show effect lighting, theatre lighting); or (iii) the scene or object lit requires special protection from the negative effects of the light source (such as lighting with dedicated filtering for photosensitive patients or photosensitive museum exhibits); or (iv) lighting is required only for emergency situations (such as emergency lighting luminaires or control gears for emergency lighting); or (v) the lighting products have to withstand extreme physical conditions (such as vibrations or temperatures below – 20 °C or above 50 °C);
Incandescent lamps longer than 60 mm are not special purpose products, if they are resistant only to mechanical shock or vibrations and are not incandescent traffic signalling lamps; or they possess a rated power higher than 25 W and claim to have specific features that are also present in lamps having higher energy efficiency classes according to Regulation (EU) No 874/2012 (such as zero EMC emissions, CRI value higher or equal to 95, and UV emissions less or equal than 2 mW per 1 000 lm)
light source means a surface or object designed to emit mainly visible optical radiation produced by a transformation of energy. The term ‘visible’ refers to a wavelength of 380-780 nm
lamp means a unit whose performance can be assessed independently and which consists of one or more light sources. It may include additional components necessary for starting, power supply or stable operation of the unit or for distributing, filtering or transforming the optical radiation, in cases where those components cannot be removed without permanently damaging the unit
lamp cap means that part of a lamp which provides connection to the electrical supply by means of a lamp holder or lamp connector and may also serve to retain the lamp in the lamp holder
‘lamp holder’ or ‘socket’ means a device which holds the lamp in position, usually by having the cap inserted in it, in which case it also provides the means of connecting the lamp to the electric supply
directional lamp means a lamp having at least 80% light output within a solid angle of π sr (corresponding to a cone with angle of 120°)
non-directional lamp means a lamp that is not a directional lamp
filament lamp means a lamp in which light is produced by means of a threadlike conductor which is heated to incandescence by the passage of an electric current. The lamp may contain gases influencing the process of incandescence
incandescent lamp means a filament lamp in which the filament operates in an evacuated bulb or is surrounded by inert gas
(tungsten) halogen lamp means a filament lamp in which the filament is made of tungsten and is surrounded by gas containing halogens or halogen compounds; it may be supplied with an integrated power supply
discharge lamp means a lamp in which the light is produced, directly or indirectly, by an electric discharge through a gas, a metal vapour or a mixture of several gases and vapours
fluorescent lamp means a discharge lamp of the low-pressure mercury type in which most of the light is emitted by one or more layers of phosphors excited by the ultraviolet radiation from the discharge. Fluorescent lamps may be supplied with an integrated ballast
fluorescent lamp without integrated ballast means a single- or double-capped fluorescent lamp without integrated ballast
high intensity discharge lamp means an electric discharge lamp in which the light- producing arc is stabilised by wall temperature and the arc has a bulb wall loading in excess of 3 watts per square centimetre
світловипромінювальний діод (світлодіод) значає джерело світла, що складається з твердотілового пристрою з p-n переходом неорганічного матеріалу. Перехід утворює оптичне випромінення під час збудження електричним струмом
LED package means an assembly having one or more LED(s). The assembly may include an optical element and thermal, mechanical and electrical interfaces
LED module means an assembly having no cap and incorporating one or more LED packages on a printed circuit board. The assembly may have electrical, optical, mechanical and thermal components, interfaces and control gear
LED lamp means a lamp incorporating one or more LED modules. The lamp may be equipped with a cap
lamp control gear means a device located between the electrical supply and one or more lamps, which provides a functionality related to the operation of the lamp(s), such as transforming the supply voltage, limiting the current of the lamp(s) to the required value, providing starting voltage and preheating current, preventing cold starting, correcting the power factor or reducing radio interference. The device may be designed to connect to other lamp control gear to perform these functions. The term does not include: control devices, power supplies within the scope of Commission Regulation (EC) No 278/2009
control device means an electronic or mechanical device controlling or monitoring the luminous flux of the lamp by other means than power conversion, such as timer switches, occupancy sensors, light sensors and daylight regulation devices. In addition, phase cut dimmers shall also be considered as control devices
external lamp control gear means non-integrated lamp control gear designed to be installed outside the enclosure of a lamp or luminaire, or to be removed from the enclosure without permanently damaging the lamp or the luminaire
ballast means lamp control gear inserted between the supply and one or more discharge lamps which, by means of inductance, capacitance or a combination of inductance and capacitance, serves mainly to limit the current of the lamp(s) to the required value
halogen lamp control gear means lamp control gear that transforms mains voltage to extra low voltage for halogen lamps
compact fluorescent lamp means a fluorescent lamp that includes all the components necessary for starting and stable operation of the lamp
luminaire means a product which distributes, filters or transforms the light transmitted from one or more lamps and includes all the parts necessary for supporting, fixing and protecting the lamps and, where necessary, circuit auxiliaries together with the means for connecting them to the electric supply. If the primary purpose of a product is not lighting and the product is dependent on energy input in fulfilling its primary purpose during use (such as refrigerators, sewing machines, endoscopes, blood analysers) it is not considered a luminaire for the purposes of this Regulation
end-user means a natural person buying or expected to buy a product for purposes which are outside his trade, business, craft or profession
final owner means the person or entity owning a product during the use phase of its life cycle, or any person or entity acting on behalf of such a person or entity
incandescent traffic signalling lamp means an incandescent lamp with a rated voltage above 60 V, and a failure rate of less than 2% during the first 1 000 hours of operation
luminous flux (Φ) means the quantity derived from radiant flux (radiant power) by evaluating the radiation in accordance with the spectral sensitivity of the human eye. Without further specification it refers to the initial luminous flux
initial luminous flux means the luminous flux of a lamp after a short operating period
useful luminous flux (Φuse) means the part of the luminous flux of a lamp falling within the cone used for calculating the lamp’s energy efficiency in point 1.1 of Annex III
luminous intensity (candela or cd) means the quotient of the luminous flux leaving the source and propagated in the element of solid angle containing the given direction, by the element of solid angle
beam angle means the angle between two imaginary lines in a plane through the optical beam axis, such that these lines pass through the centre of the front face of the lamp and through points at which the luminous intensity is 50% of the centre beam intensity, where the centre beam intensity is the value of luminous intensity measured on the optical beam axis
correlated colour temperature (Tc [K]) means the temperature of a Planckian (black body) radiator whose perceived colour most closely resembles that of a given stimulus at the same brightness and under specified viewing conditions
chromaticity means the property of a colour stimulus defined by its chromaticity coordinates, or by its dominant or complementary wavelength and purity taken together
colour rendering (Ra) means the effect of an illuminant on the colour appearance of objects by conscious or subconscious comparison with their colour appearance under a reference illuminant
colour consistency means the maximum deviation of chromaticity coordinates (x and y) of a single lamp from a chromaticity centre point (cx and cy), expressed as the size (in steps) of the MacAdam ellipse formed around the chromaticity centre point (cx and cy)
lamp lumen maintenance factor (LLMF) means the ratio of the luminous flux emitted by the lamp at a given time in its life to the initial luminous flux
lamp survival factor (LSF) means the defined fraction of the total number of lamps that continue to operate at a given time under defined conditions and switching frequency
lamp lifetime means the period of operating time after which the fraction of the total number of lamps which continue to operate corresponds to the lamp survival factor of the lamp under defined conditions and switching frequency. For LED lamps, lamp lifetime means the operating time between the start of their use and the moment when only 50% of the total number of lamps survive or when the average lumen maintenance of the batch falls below 70%, whichever occurs first
lamp start time means the time needed, after the supply voltage is switched on, for the lamp to start fully and remain alight
lamp warm-up time means the time needed after start-up, for the lamp to emit a defined proportion of its stabilised luminous flux
power factor means the ratio of the absolute value of the active power to the apparent power under periodic conditions
lamp mercury content means the mercury contained in the lamp
rated value means the value of a quantity used for specification purposes, established for a specified set of operating conditions of a product. Unless stated otherwise, all requirements are set in rated values
nominal value means the value of a quantity used to designate and identify a product
no-load mode means the condition of a lamp control gear where it is connected to the supply voltage and where its output is disconnected in normal operation from all the primary loads by the switch intended for this purpose (a faulty or missing lamp, or a disconnection of the load by a safety switch is not normal operation)
standby mode means a mode of lamp control gear where the lamps are switched off with the help of a control signal under normal operating conditions. It applies to lamp control gear with a built-in switching function and permanently connected to the supply voltage when in normal use
control signal means an analogue or digital signal transmitted to the control gear wirelessly or wired either via voltage modulation in separate control cables or via modulated signal in the supply voltage
standby power means the power consumed by the lamp control gear in standby mode
no-load power means the power consumed by the lamp control gear in no-load mode
switching cycle means the sequence of switching the lamp on and off at set intervals
premature failure means when a lamp reaches the end of its life after a period in operation which is less than the rated life time stated in the technical documentation
anti-glare shield means a mechanical or optical reflective or non-reflective impervious baffle designed to block direct visible radiation emitted from the light source of a directional lamp, in order to avoid temporary partial blindness (disability glare) if viewed directly by an observer. It does not include surface coating of the light source in the directional lamp
compatibility means that when a product is intended to be installed in an installation, inserted into another product or connected to it through physical contact or wireless connection, (i) it is possible to perform the installation, insertion or connection; and (ii) shortly after starting to use them together, end-users are not led to believe that any of the products has a defect; and (iii) the safety risk of using the products together is not higher than when the same products taken individually are used in combination with other products
quality schemes means the schemes established under Titles II, III and IV
group means any association, irrespective of its legal form, mainly composed of producers or processors working with the same product
traditional means proven usage on the domestic market for a period that allows transmission between generations; this period is to be at least 30 years
labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a foodstuff and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such foodstuff
specific character in relation to a product means the characteristic production attributes which distinguish a product clearly from other similar products of the same category
generic terms means the names of products which, although relating to the place, region or country where the product was originally produced or marketed, have become the common name of a product in the Union
production step means production, processing or preparation
processed products means foodstuffs resulting from the processing of unprocessed products. Processed products may contain ingredients that are necessary for their manufacture or to give them specific characteristics
legal aid means funding by a Member State of the assistance of a lawyer, enabling the exercise of the right of access to a lawyer
competent authority shall mean the central authority of a Member State competent for the organisation of official checks referred to in point VII of Annex XIa to Regulation (EC) No 1234/2007 or any other authority to which that competence has been conferred; it shall also include, where appropriate, the corresponding authority of a third country
ship means a ship or craft flying the flag of a Member State falling within the scope of the relevant IMO Conventions, and for which a certificate is required
administration means the competent authorities of the Member State whose flag the ship is flying
recognised organisation means an organisation recognised in accordance with Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (recast)
certificates means statutory certificates issued in respect of the relevant IMO Conventions
IMO audit means an audit conducted in accordance with the provisions of Resolution A.974(24) adopted by the IMO Assembly on 1 December 2005
the ISM Code means the International Management Code for the Safe Operation of Ships and for Pollution Prevention adopted by the International Maritime Organisation by Assembly Resolution A.741(18) of 4 November 1993, as amended by Maritime Safety Committee Resolution MSC.104(73) of 5 December 2000 and set out in Annex I to this Regulation, in its up-to-date version
company means the owner of the ship or any other organisation or person, such as the manager or the bareboat charterer, who has assumed responsibility for the operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed by the ISM Code
recognised organisation means a body recognised in accordance with Directive 94/57/EC
passenger ship means a ship, including a high-speed craft, carrying more than 12 passengers, or a passenger submersible craft
high-speed craft means a high-speed craft as defined in Regulation X-1/2 of SOLAS, in its up-to-date version. For high-speed passenger craft, the limitations indicated in Article 2(f) of Directive 98/18/EC shall apply
passenger means every person other than (a) the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship and (b) a child under one year of age
cargo ship means a ship, including a high-speed craft, which is not a passenger ship
international voyage means a voyage by sea from a port of a Member State or any other State to a port outside that State, or vice versa
regular shipping service means a series of ship crossings operated so as to serve traffic between the same two or more points, either (a) according to a published timetable or (b) with crossings so regular or frequent that they constitute a recognisable systematic series
domestic voyage means a voyage in sea areas from a port of a Member State to the same or another port within that Member State
ro-ro passenger ferry means a seagoing passenger vessel as defined in Chapter II-1 of SOLAS, in its up-to-date version
passenger submersible craft means a passenger-carrying mobile vessel which primarily operates under water and relies on surface support, such as a surface ship or shore-based facilities, for monitoring and for one or more of the following: (a) recharging of power supply; (b) recharging high pressure air; (c) recharging life-support
mobile offshore drilling unit means a vessel capable of engaging in drilling operations for the exploration for or exploitation of resources beneath the seabed such as liquid or gaseous hydrocarbons, sulphur or salt
gross tonnage means the gross tonnage of a ship determined in accordance with the International Convention on Tonnage Measurement of Ships, 1969 or, in the case of ships engaged exclusively on domestic voyages and not measured in accordance with the said Convention, the gross tonnage of the ship determined in accordance with national tonnage measurement regulations
International Safety Management (ISM) Code means the International Management Code for the Safe Operation of Ships and for Pollution Prevention as adopted by the Assembly, as may be amended by the organisation
administration means the government of the State whose flag the ship is entitled to fly
company means the owner of the ship or any other organisation or person such as the manager or the bareboat charterer, who has assumed the responsibility for the operation of the ship from the shipowner and who on assuming such responsibility has agreed to take over all the duties and responsibility imposed by the Code
safety management system means a structured and documented system enabling company personnel to implement effectively the company safety and environmental protection policy
Document of Compliance means a document issued to a company which complies with the requirements of this Code
Safety Management Certificate means a document issued to a ship which signifies that the company and its shipboard management operate in accordance with the approved safety management system
Objective evidence means quantitative or qualitative information, records or statements of fact pertaining to safety or to the existence and implementation of a safety management system element, which is based on observation, measurement or test and which can be verified
Observation means a statement of fact made during a safety management audit and substantiated by objective evidence
Non-conformity means an observed situation where objective evidence indicates the non-fulfilment of a specified requirement
Major non-conformity means an identifiable deviation that poses a serious threat to the safety of personnel or the ship or a serious risk to the environment that requires immediate corrective action and includes the lack of effective and systematic implementation of a requirement of this Code
Anniversary date means the day and month of each year that corresponds to the date of expiry of the relevant document or certificate
Convention means the International Convention for the Safety of Life at Sea, 1974 as amended
infrastructure for spatial information means metadata, spatial data sets and spatial data services; network services and technologies; agreements on sharing, access and use; and coordination and monitoring mechanisms, processes and procedures, established, operated or made available in accordance with this Directive
spatial data means any data with a direct or indirect reference to a specific location or geographical area
spatial data set means an identifiable collection of spatial data
spatial data services means the operations which may be performed, by invoking a computer application, on the spatial data contained in spatial data sets or on the related metadata
spatial object means an abstract representation of a real-world phenomenon related to a specific location or geographical area
interoperability means the possibility for spatial data sets to be combined, and for services to interact, without repetitive manual intervention, in such a way that the result is coherent and the added value of the data sets and services is enhanced
metadata means information describing spatial data sets and spatial data services and making it possible to discover, inventory and use them
Inspire geo-portal means an Internet site, or equivalent, providing access to the services referred to in Article 11(1)
public authority means: (a) any government or other public administration, including public advisory bodies, at national, regional or local level; (b) any natural or legal person performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and (c) any natural or legal person having public responsibilities or functions, or providing public services relating to the environment under the control of a body or person falling within (a) or (b).
Member States may provide that when bodies or institutions are acting in a judicial or legislative capacity, they are not to be regarded as a public authority for the purposes of this Directive
third party means any natural or legal person other than a public authority
Reporting Financial Institution means any Member State Financial Institution that is not a Non-Reporting Financial Institution. The term “Member State Financial Institution” means: (i) any Financial Institution that is resident in a Member State, but excludes any branch of that Financial Institution that is located outside that Member State; and (ii) any branch of a Financial Institution that is not resident in a Member State, if that branch is located in that Member State
Financial Institution means a Custodial Institution, a Depository Institution, an Investment Entity, or a Specified Insurance Company
Participating Jurisdiction Financial Institution means (i) any Financial Institution that is resident in a Participating Jurisdiction, but excludes any branch of that Financial Institution that is located outside such Participating Jurisdiction; and (ii) any branch of a Financial Institution that is not resident in a Participating Jurisdiction, if that branch is located in such Participating Jurisdiction
Custodial Institution means any Entity that holds, as a substantial portion of its business, Financial Assets for the account of others. An Entity holds Financial Assets for the account of others as a substantial portion of its business if the Entity's gross income attributable to the holding of Financial Assets and related financial services equals or exceeds 20% of the Entity's gross income during the shorter of: (i) the three-year period that ends on 31 December (or the final day of a non-calendar year accounting period) prior to the year in which the determination is being made; or (ii) the period during which the Entity has been in existence
Depository Institution means any Entity that accepts deposits in the ordinary course of a banking or similar business
Investment Entity means any Entity: (a) which primarily conducts as a business one or more of the following activities or operations for or on behalf of a customer: (i) trading in money market instruments (cheques, bills, certificates of deposit, derivatives, etc.); foreign exchange; exchange, interest rate and index instruments; transferable securities; or commodity futures trading; (ii) individual and collective portfolio management; or (iii) otherwise investing, administering, or managing Financial Assets or money on behalf of other persons; or
(b) the gross income of which is primarily attributable to investing, reinvesting, or trading in Financial Assets, if the Entity is managed by another Entity that is a Depository Institution, a Custodial Institution, a Specified Insurance Company, or an Investment Entity described in subparagraph A(6)(a).
An Entity is treated as primarily conducting as a business one or more of the activities described in subparagraph A(6)(a), or an Entity's gross income is primarily attributable to investing, reinvesting, or trading in Financial Assets for the purposes of subparagraph A(6)(b), if the Entity's gross income attributable to the relevant activities equals or exceeds 50% of the Entity's gross income during the shorter of: (i) the three-year period ending on 31 December of the year preceding the year in which the determination is made; or (ii) the period during which the Entity has been in existence. The term “Investment Entity” does not include an Entity that is an Active NFE because that Entity meets any of the criteria in subparagraphs D(8)(d) through (g).
This paragraph shall be interpreted in a manner consistent with similar language set forth in the definition of “financial institution” in the Financial Action Task Force Recommendations
Specified Insurance Company means any Entity that is an insurance company (or the holding company of an insurance company) which issues, or is obligated to make payments with respect to, a Cash Value Insurance Contract or an Annuity Contract
Financial Asset includes a security (for example, a share of stock in a corporation; partnership or beneficial ownership interest in a widely held or publicly traded partnership or trust; note, bond, debenture, or other evidence of indebtedness), partnership interest, commodity, swap (for example, interest rate swaps, currency swaps, basis swaps, interest rate caps, interest rate floors, commodity swaps, equity swaps, equity index swaps, and similar agreements), Insurance Contract or Annuity Contract, or any interest (including a futures or forward contract or option) in a security, partnership interest, commodity, swap, Insurance Contract, or Annuity Contract. The term “Financial Asset” does not include a non-debt, direct interest in real property
Non-Reporting Financial Institution means any Financial Institution which is: (a) a Governmental Entity, International Organisation or Central Bank, other than with respect to a payment that is derived from an obligation held in connection with a commercial financial activity of a type engaged in by a Specified Insurance Company, Custodial Institution, or Depository Institution; (b) a Broad Participation Retirement Fund; a Narrow Participation Retirement Fund; a Pension Fund of a Governmental Entity, International Organisation or Central Bank; or a Qualified Credit Card Issuer; (c) any other Entity that presents a low risk of being used to evade tax, has substantially similar characteristics to any of the Entities described in subparagraphs B(1)(a) and (b), and is included in the list of Non-Reporting Financial Institutions referred to in Article 8(7a) of this Directive, provided that the status of such Entity as a Non-Reporting Financial Institution does not frustrate the purposes of this Directive; (d) an Exempt Collective Investment Vehicle; or (e) a trust to the extent that the trustee of the trust is a Reporting Financial Institution and reports all information required to be reported pursuant to Section I with respect to all Reportable Accounts of the trust
Governmental Entity means the government of a Member State or other jurisdiction, any political subdivision of a Member State or other jurisdiction (which, for the avoidance of doubt, includes a state, province, county, or municipality), or any wholly owned agency or instrumentality of a Member State or other jurisdiction or of any one or more of the foregoing (each, a “Governmental Entity”). This category is comprised of the integral parts, controlled entities, and political subdivisions of a Member State or other jurisdiction.
(a) An “integral part” of a Member State or other jurisdiction means any person, organisation, agency, bureau, fund, instrumentality, or other body, however designated, that constitutes a governing authority of a Member State or other jurisdiction. The net earnings of the governing authority must be credited to its own account or to other accounts of the Member State or other jurisdiction, with no portion inuring to the benefit of any private person. An integral part does not include any individual who is a sovereign, official, or administrator acting in a private or personal capacity.
(b) A “controlled entity” means an Entity which is separate in form from the Member State or other jurisdiction or which otherwise constitutes a separate juridical entity, provided that: (i) the Entity is wholly owned and controlled by one or more Governmental Entities directly or through one or more controlled entities; (ii) the Entity's net earnings are credited to its own account or to the accounts of one or more Governmental Entities, with no portion of its income inuring to the benefit of any private person; and (iii) the Entity's assets vest in one or more Governmental Entities upon dissolution.
(c) Income does not inure to the benefit of private persons if such persons are the intended beneficiaries of a governmental programme, and the programme activities are performed for the general public with respect to the common welfare or relate to the administration of some phase of government. Notwithstanding the foregoing, however, income is considered to inure to the benefit of private persons if the income is derived from the use of a Governmental Entity to conduct a commercial business, such as a commercial banking business, that provides financial services to private persons
International Organisation means any international organisation or wholly owned agency or instrumentality thereof. This category includes any intergovernmental organisation (including a supranational organisation) (i) that is comprised primarily of governments; (ii) that has in effect a headquarters or substantially similar agreement with the Member State; and (iii) the income of which does not inure to the benefit of private persons
Central Bank means an institution that is by law or government sanction the principal authority, other than the government of the Member State itself, issuing instruments intended to circulate as currency. Such an institution may include an instrumentality that is separate from the government of the Member State, whether or not owned in whole or in part by the Member State
Broad Participation Retirement Fund means a fund established to provide retirement, disability, or death benefits, or any combination thereof, to beneficiaries who are current or former employees (or persons designated by such employees) of one or more employers in consideration for services rendered, provided that the fund: (a) does not have a single beneficiary with a right to more than 5% of the fund's assets; (b) is subject to government regulation and provides information reporting to the tax authorities; and (c) satisfies at least one of the following requirements: (i) the fund is generally exempt from tax on investment income, or taxation of such income is deferred or taxed at a reduced rate, due to its status as a retirement or pension plan; (ii) the fund receives at least 50% of its total contributions (other than transfers of assets from other plans described in subparagraphs B(5) through (7) or from retirement and pension accounts described in subparagraph C(17)(a)) from the sponsoring employers; (iii) distributions or withdrawals from the fund are allowed only upon the occurrence of specified events related to retirement, disability, or death (except rollover distributions to other retirement funds described in subparagraphs B(5) through (7) or retirement and pension accounts described in subparagraph C(17)(a)), or penalties apply to distributions or withdrawals made before such specified events; or (iv) contributions (other than certain permitted make-up contributions) by employees to the fund are limited by reference to earned income of the employee or may not exceed, annually, an amount denominated in the domestic currency of each Member State that corresponds to USD 50 000, applying the rules set forth in paragraph C of Section VII for account aggregation and currency translation
Narrow Participation Retirement Fund means a fund established to provide retirement, disability, or death benefits to beneficiaries who are current or former employees (or persons designated by such employees) of one or more employers in consideration for services rendered, provided that: (a) the fund has fewer than 50 participants; (b) the fund is sponsored by one or more employers that are not Investment Entities or Passive NFEs; (c) the employee and employer contributions to the fund (other than transfers of assets from retirement and pension accounts described in subparagraph C(17)(a)) are limited by reference to earned income and compensation of the employee, respectively; (d) participants that are not residents of the Member State in which the fund is established are not entitled to more than 20% of the fund's assets; and (e) the fund is subject to government regulation and provides information reporting to the tax authorities
Pension Fund of a Governmental Entity, International Organisation or Central Bank means a fund established by a Governmental Entity, International Organisation or Central Bank to provide retirement, disability, or death benefits to beneficiaries or participants who are current or former employees (or persons designated by such employees), or who are not current or former employees, if the benefits provided to such beneficiaries or participants are in consideration of personal services performed for the Governmental Entity, International Organisation or Central Bank
Qualified Credit Card Issuer means a Financial Institution satisfying the following requirements: (a) the Financial Institution is a Financial Institution solely because it is an issuer of credit cards that accepts deposits only when a customer makes a payment in excess of a balance due with respect to the card and the overpayment is not immediately returned to the customer; and (b) beginning on or before 1 January 2016, the Financial Institution implements policies and procedures either to prevent a customer from making an overpayment in excess of an amount denominated in the domestic currency of each Member State that corresponds to USD 50 000, or to ensure that any customer overpayment in excess of that amount is refunded to the customer within 60 days, in each case applying the rules set forth in paragraph C of Section VII for account aggregation and currency translation. For this purpose, a customer overpayment does not refer to credit balances to the extent of disputed charges but does include credit balances resulting from merchandise returns
Exempt Collective Investment Vehicle means an Investment Entity that is regulated as a collective investment vehicle, provided that all of the interests in the collective investment vehicle are held by or through individuals or Entities that are not Reportable Persons, except a Passive NFE with Controlling Persons who are Reportable Persons.
An Investment Entity that is regulated as a collective investment vehicle does not fail to qualify under subparagraph B(9) as an Exempt Collective Investment Vehicle, solely because the collective investment vehicle has issued physical shares in bearer form, provided that: (a) the collective investment vehicle has not issued, and does not issue, any physical shares in bearer form after 31 December 2015; (b) the collective investment vehicle retires all such shares upon surrender; (c) the collective investment vehicle performs the due diligence procedures set forth in Sections II through VII and reports any information required to be reported with respect to any such shares when such shares are presented for redemption or other payment; and (d) the collective investment vehicle has in place policies and procedures to ensure that such shares are redeemed or immobilised as soon as possible, and in any event prior to 1 January 2018.
Financial Account means an account maintained by a Financial Institution, and includes a Depository Account, a Custodial Account and: (a) in the case of an Investment Entity, any equity or debt interest in the Financial Institution. Notwithstanding the foregoing, the term “Financial Account” does not include any equity or debt interest in an Entity that is an Investment Entity solely because it (i) renders investment advice to, and acts on behalf of; or (ii) manages portfolios for, and acts on behalf of, a customer for the purpose of investing, managing, or administering Financial Assets deposited in the name of the customer with a Financial Institution other than such Entity; (b) in the case of a Financial Institution not described in subparagraph C(1)(a), any equity or debt interest in the Financial Institution, if the class of interests was established with the purpose of avoiding reporting in accordance with Section I; and (c) any Cash Value Insurance Contract and any Annuity Contract issued or maintained by a Financial Institution, other than a non-investment-linked, non-transferable immediate life annuity that is issued to an individual and monetises a pension or disability benefit provided under an account that is an Excluded Account.
The term “Financial Account” does not include any account that is an Excluded Account.
Depository Account includes any commercial, checking, savings, time, or thrift account, or an account that is evidenced by a certificate of deposit, thrift certificate, investment certificate, certificate of indebtedness, or other similar instrument maintained by a Financial Institution in the ordinary course of a banking or similar business. A Depository Account also includes an amount held by an insurance company pursuant to a guaranteed investment contract or similar agreement to pay or credit interest thereon
Custodial Account means an account (other than an Insurance Contract or Annuity Contract) which holds one or more Financial Assets for the benefit of another person
Equity Interest means, in the case of a partnership that is a Financial Institution, either a capital or profits interest in the partnership. In the case of a trust that is a Financial Institution, an Equity Interest is considered to be held by any person treated as a settlor or beneficiary of all or a portion of the trust, or any other natural person exercising ultimate effective control over the trust. A Reportable Person will be treated as being a beneficiary of a trust if such Reportable Person has the right to receive directly or indirectly (for example, through a nominee) a mandatory distribution or may receive, directly or indirectly, a discretionary distribution from the trust
Insurance Contract means a contract (other than an Annuity Contract) under which the issuer agrees to pay an amount upon the occurrence of a specified contingency involving mortality, morbidity, accident, liability, or property risk
Annuity Contract means a contract under which the issuer agrees to make payments for a period of time determined in whole or in part by reference to the life expectancy of one or more individuals. The term also includes a contract that is considered to be an Annuity Contract in accordance with the law, regulation, or practice of the Member State or other jurisdiction in which the contract was issued, and under which the issuer agrees to make payments for a term of years
Cash Value Insurance Contract means an Insurance Contract (other than an indemnity reinsurance contract between two insurance companies) that has a Cash Value
Cash Value means the greater of (i) the amount that the policyholder is entitled to receive upon surrender or termination of the contract (determined without reduction for any surrender charge or policy loan); and (ii) the amount the policyholder can borrow under or with regard to the contract. Notwithstanding the foregoing, the term “Cash Value” does not include an amount payable under an Insurance Contract: (a) solely by reason of the death of an individual insured under a life insurance contract; (b) as a personal injury or sickness benefit or other benefit providing indemnification of an economic loss incurred upon the occurrence of the event insured against; (c) as a refund of a previously paid premium (less cost of insurance charges whether or not actually imposed) under an Insurance Contract (other than an investment-linked life insurance or annuity contract) due to cancellation or termination of the contract, decrease in risk exposure during the effective period of the contract, or arising from the correction of a posting or similar error with regard to the premium for the contract; (d) as a policyholder dividend (other than a termination dividend) provided that the dividend relates to an Insurance Contract under which the only benefits payable are described in subparagraph C(8)(b); or (e) as a return of an advance premium or premium deposit for an Insurance Contract for which the premium is payable at least annually if the amount of the advance premium or premium deposit does not exceed the next annual premium that will be payable under the contract
Pre-existing Account means: (a) a Financial Account maintained by a Reporting Financial Institution as of 31 December 2015;
(b) any Financial Account of an Account Holder, regardless of the date such Financial Account was opened, if: (i) the Account Holder also holds with the Reporting Financial Institution (or with a Related Entity within the same Member State as the Reporting Financial Institution) a Financial Account that is a Pre-existing Account under subparagraph C(9)(a); (ii) the Reporting Financial Institution (and, as applicable, the Related Entity within the same Member State as the Reporting Financial Institution) treats both of the aforementioned Financial Accounts, and any other Financial Accounts of the Account Holder that are treated as Pre-existing Accounts under point (b), as a single Financial Account for purposes of satisfying the standards of knowledge requirements set forth in paragraph A of Section VII, and for purposes of determining the balance or value of any of the Financial Accounts when applying any of the account thresholds; (iii) with respect to a Financial Account that is subject to AML/KYC Procedures, the Reporting Financial Institution is permitted to satisfy such AML/KYC Procedures for the Financial Account by relying upon the AML/KYC Procedures performed for the Pre-existing Account described in subparagraph C(9)(a); and (iv) the opening of the Financial Account does not require the provision of new, additional or amended customer information by the Account Holder other than for the purposes of this Directive
New Account means a Financial Account maintained by a Reporting Financial Institution opened on or after 1 January 2016 unless it is treated as a Pre-existing Account under subparagraph C(9)(b)
Pre-existing Individual Account means a Pre-existing Account held by one or more individuals
New Individual Account means a New Account held by one or more individuals
Pre-existing Entity Account means a Pre-existing Account held by one or more Entities
Lower Value Account means a Pre-existing Individual Account with an aggregate balance or value as of 31 December 2015 that does not exceed an amount denominated in the domestic currency of each Member State that corresponds to USD 1 000 000
High Value Account means a Pre-existing Individual Account with an aggregate balance or value that exceeds, as of 31 December 2015, or 31 December of any subsequent year, an amount denominated in the domestic currency of each Member State that corresponds to USD 1 000 000
New Entity Account means a New Account held by one or more Entities
Excluded Account means any of the following accounts:
(a) a retirement or pension account that satisfies the following requirements: (i) the account is subject to regulation as a personal retirement account or is part of a registered or regulated retirement or pension plan for the provision of retirement or pension benefits (including disability or death benefits); (ii) the account is tax-favoured (i.e., contributions to the account that would otherwise be subject to tax are deductible or excluded from the gross income of the Account Holder or taxed at a reduced rate, or taxation of investment income from the account is deferred or taxed at a reduced rate); (iii) information reporting is required to the tax authorities with respect to the account; (iv) withdrawals are conditioned on reaching a specified retirement age, disability, or death, or penalties apply to withdrawals made before such specified events; and (v) either (i) annual contributions are limited to an amount denominated in the domestic currency of each Member State that corresponds to USD 50 000 or less; or (ii) there is a maximum lifetime contribution limit to the account of an amount denominated in the domestic currency of each Member State that corresponds to USD 1 000 000 or less, in each case applying the rules set forth in paragraph C of Section VII for account aggregation and currency translation. A Financial Account that otherwise satisfies the requirement of subparagraph C(17)(a)(v) will not fail to satisfy such requirement solely because such Financial Account may receive assets or funds transferred from one or more Financial Accounts that meet the requirements of subparagraph C(17)(a) or (b) or from one or more retirement or pension funds that meet the requirements of any of subparagraphs B(5) through (7);
(b) an account that satisfies the following requirements: (i) the account is subject to regulation as an investment vehicle for purposes other than for retirement and is regularly traded on an established securities market, or the account is subject to regulation as a savings vehicle for purposes other than for retirement; (ii) the account is tax-favoured (i.e., contributions to the account that would otherwise be subject to tax are deductible or excluded from the gross income of the Account Holder or taxed at a reduced rate, or taxation of investment income from the account is deferred or taxed at a reduced rate); (iii)
withdrawals are conditioned on meeting specific criteria related to the purpose of the investment or savings account (for example, the provision of educational or medical benefits), or penalties apply to withdrawals made before such criteria are met; and (iv) annual contributions are limited to an amount denominated in the domestic currency of each Member State that corresponds to USD 50 000 or less, applying the rules set forth in paragraph C of Section VII for account aggregation and currency translation. A Financial Account that otherwise satisfies the requirement of subparagraph C(17)(b)(iv) will not fail to satisfy such requirement solely because such Financial Account may receive assets or funds transferred from one or more Financial Accounts that meet the requirements of subparagraph C(17)(a) or (b) or from one or more retirement or pension funds that meet the requirements of any of subparagraphs B(5) through (7);
(c) a life insurance contract with a coverage period that will end before the insured individual attains age 90, provided that the contract satisfies the following requirements: (i) periodic premiums, which do not decrease over time, are payable at least annually during the period the contract is in existence or until the insured attains age 90, whichever is shorter; (ii) the contract has no contract value that any person can access (by withdrawal, loan, or otherwise) without terminating the contract; (iii) the amount (other than a death benefit) payable upon cancellation or termination of the contract cannot exceed the aggregate premiums paid for the contract, less the sum of mortality, morbidity, and expense charges (whether or not actually imposed) for the period or periods of the contract's existence and any amounts paid prior to the cancellation or termination of the contract; and (iv) the contract is not held by a transferee for value;
(d) an account that is held solely by an estate if the documentation for such account includes a copy of the deceased's will or death certificate;
(e) an account established in connection with any of the following: (i) a court order or judgment. (ii) a sale, exchange, or lease of real or personal property, provided that the account satisfies the following requirements:
— the account is funded solely with a down payment, earnest money, deposit in an amount appropriate to secure an obligation directly related to the transaction, or a similar payment, or is funded with a Financial Asset that is deposited in the account in connection with the sale, exchange, or lease of the property,
— the account is established and used solely to secure the obligation of the purchaser to pay the purchase price for the property, the seller to pay any contingent liability, or the lessor or lessee to pay for any damages relating to the leased property as agreed under the lease,
— the assets of the account, including the income earned thereon, will be paid or otherwise distributed for the benefit of the purchaser, seller, lessor, or lessee (including to satisfy such person's obligation) when the property is sold, exchanged, or surrendered, or the lease terminates,
— the account is not a margin or similar account established in connection with a sale or exchange of a Financial Asset, and
— the account is not associated with an account described in subparagraph C(17)(f); (iii) an obligation of a Financial Institution servicing a loan secured by real property to set aside a portion of a payment solely to facilitate the payment of taxes or insurance related to the real property at a later time; (iv) an obligation of a Financial Institution solely to facilitate the payment of taxes at a later time;
(f) a Depository Account that satisfies the following requirements: (i) the account exists solely because a customer makes a payment in excess of a balance due with respect to a credit card or other revolving credit facility and the overpayment is not immediately returned to the customer; and (ii) beginning on or before 1 January 2016, the Financial Institution implements policies and procedures either to prevent a customer from making an overpayment in excess of an amount denominated in the domestic currency of each Member State that corresponds to USD 50 000, or to ensure that any customer overpayment in excess of that amount is refunded to the customer within 60 days, in each case applying the rules set forth in paragraph C of Section VII for currency translation. For this purpose, a customer overpayment does not refer to credit balances to the extent of disputed charges but does include credit balances resulting from merchandise returns;
(g) any other account that presents a low risk of being used to evade tax, has substantially similar characteristics to any of the accounts described in subparagraphs C(17)(a) through (f), and is included in the list of Excluded Accounts referred to in Article 8(7a) of this Directive, provided that the status of such account as an Excluded Account does not frustrate the purposes of this Directive
Reportable Account means a Financial Account that is maintained by a Member State Reporting Financial Institution and is held by one or more Reportable Persons or by a Passive NFE with one or more Controlling Persons that is a Reportable Person, provided it has been identified as such pursuant to the due diligence procedures described in Sections II through VII
Reportable Person means a Member State Person other than: (i) a corporation the stock of which is regularly traded on one or more established securities markets; (ii) any corporation that is a Related Entity of a corporation described in clause (i); (iii) a Governmental Entity; (iv) an International Organisation; (v) a Central Bank; or (vi) a Financial Institution
Member State Person with regard to each Member State means an individual or Entity that is resident in any other Member State under the tax laws of that other Member State, or an estate of a decedent that was a resident of any other Member State. For this purpose, an Entity such as a partnership, limited liability partnership or similar legal arrangement, which has no residence for tax purposes shall be treated as resident in the jurisdiction in which its place of effective management is situated
Participating Jurisdiction with regard to each Member State means: (a) any other Member State; (b) any other jurisdiction (i) with which the Member State concerned has an agreement in place pursuant to which that jurisdiction will provide the information specified in Section I; and (ii) which is identified in a list published by that Member State and notified to the European Commission; (c) any other jurisdiction (i) with which the Union has an agreement in place pursuant to which that jurisdiction will provide the information specified in Section I; and (ii) which is identified in a list published by the European Commission
Controlling Persons means the natural persons who exercise control over an Entity. In the case of a trust, that term means the settlor(s), the trustee(s), the protector(s) (if any), the beneficiary(ies) or class(es) of beneficiaries, and any other natural person(s) exercising ultimate effective control over the trust, and in the case of a legal arrangement other than a trust, such term means persons in equivalent or similar positions. The term “Controlling Persons” must be interpreted in a manner consistent with the Financial Action Task Force Recommendations
NFE means any Entity that is not a Financial Institution
Passive NFE means any: (i) NFE that is not an Active NFE; or (ii) an Investment Entity described in subparagraph A(6)(b) that is not a Participating Jurisdiction Financial Institution
Active NFE means any NFE that meets any of the following criteria:
(a) less than 50% of the NFE's gross income for the preceding calendar year or other appropriate reporting period is passive income and less than 50% of the assets held by the NFE during the preceding calendar year or other appropriate reporting period are assets that produce or are held for the production of passive income;
(b) the stock of the NFE is regularly traded on an established securities market or the NFE is a Related Entity of an Entity the stock of which is regularly traded on an established securities market;
(c) the NFE is a Governmental Entity, an International Organisation, a Central Bank, or an Entity wholly owned by one or more of the foregoing;
(d) substantially all of the activities of the NFE consist of holding (in whole or in part) the outstanding stock of, or providing financing and services to, one or more subsidiaries that engage in trades or businesses other than the business of a Financial Institution, except that an Entity does not qualify for this status if the Entity functions (or holds itself out) as an investment fund, such as a private equity fund, venture capital fund, leveraged buyout fund, or any investment vehicle whose purpose is to acquire or fund companies and then hold interests in those companies as capital assets for investment purposes;
(e) the NFE is not yet operating a business and has no prior operating history, but is investing capital into assets with the intent to operate a business other than that of a Financial Institution, provided that the NFE does not qualify for this exception after the date that is 24 months after the date of the initial organisation of the NFE;
(f) the NFE was not a Financial Institution in the past five years, and is in the process of liquidating its assets or is reorganising with the intent to continue or recommence operations in a business other than that of a Financial Institution;
(g) the NFE primarily engages in financing and hedging transactions with, or for, Related Entities that are not Financial Institutions, and does not provide financing or hedging services to any Entity that is not a Related Entity, provided that the group of any such Related Entities is primarily engaged in a business other than that of a Financial Institution; or
(h) the NFE meets all of the following requirements: (i) it is established and operated in its Member State or other jurisdiction of residence exclusively for religious, charitable, scientific, artistic, cultural, athletic, or educational purposes; or it is established and operated in its Member State or other jurisdiction of residence and it is a professional organisation, business league, chamber of commerce, labour organisation, agricultural or horticultural organisation, civic league or an organisation operated exclusively for the promotion of social welfare; (ii) it is exempt from income tax in its Member State or other jurisdiction of residence; (iii) it has no shareholders or members who have a proprietary or beneficial interest in its income or assets; (iv) the applicable laws of the NFE's Member State or other jurisdiction of residence or the NFE's formation documents do not permit any income or assets of the NFE to be distributed to, or applied for the benefit of, a private person or non-charitable Entity other than pursuant to the conduct of the NFE's charitable activities, or as payment of reasonable compensation for services rendered, or as payment representing the fair market value of property which the NFE has purchased; and (v) the applicable laws of the NFE's Member State or other jurisdiction of residence or the NFE's formation documents require that, upon the NFE's liquidation or dissolution, all of its assets be distributed to a Governmental Entity or other non-profit organisation, or escheat to the government of the NFE's Member State or other jurisdiction of residence or any political subdivision thereof
Account Holder means the person listed or identified as the holder of a Financial Account by the Financial Institution that maintains the account. A person, other than a Financial Institution, holding a Financial Account for the benefit or account of another person as agent, custodian, nominee, signatory, investment advisor, or intermediary, is not treated as holding the account for purposes of this Directive, and such other person is treated as holding the account. In the case of a Cash Value Insurance Contract or an Annuity Contract, the Account Holder is any person entitled to access the Cash Value or change the beneficiary of the contract. If no person can access the Cash Value or change the beneficiary, the Account Holder is any person named as the owner in the contract and any person with a vested entitlement to payment under the terms of the contract. Upon the maturity of a Cash Value Insurance Contract or an Annuity Contract, each person entitled to receive a payment under the contract is treated as an Account Holder
AML/KYC Procedures means the customer due diligence procedures of a Reporting Financial Institution pursuant to the anti-money laundering or similar requirements to which such Reporting Financial Institution is subject
Entity means a legal person or a legal arrangement, such as a corporation, partnership, trust, or foundation
Related Entity An Entity is a “Related Entity” of another Entity if (i) either Entity controls the other Entity; (ii) the two Entities are under common control; or (iii) the two Entities are Investment Entities described in subparagraph A(6)(b), are under common management, and such management fulfils the due diligence obligations of such Investment Entities. For this purpose control includes direct or indirect ownership of more than 50% of the vote and value in an Entity
TIN means Taxpayer Identification Number (or functional equivalent in the absence of a Taxpayer Identification Number)
Documentary Evidence includes any of the following:
(a) a certificate of residence issued by an authorised government body (for example, a government or agency thereof, or a municipality) of the Member State or other jurisdiction in which the payee claims to be a resident;
(b) with respect to an individual, any valid identification issued by an authorised government body (for example, a government or agency thereof, or a municipality), that includes the individual's name and is typically used for identification purposes;
(c) with respect to an Entity, any official documentation issued by an authorised government body (for example, a government or agency thereof, or a municipality) that includes the name of the Entity and either the address of its principal office in the Member State or other jurisdiction in which it claims to be a resident or the Member State or other jurisdiction in which the Entity was incorporated or organised;
(d) any audited financial statement, third-party credit report, bankruptcy filing, or securities regulator's report.
With respect to a Pre-existing Entity Account, Reporting Financial Institutions may use as Documentary Evidence any classification in the Reporting Financial Institution's records with respect to the Account Holder that was determined based on a standardised industry coding system, that was recorded by the Reporting Financial Institution consistent with its normal business practices for purposes of AML/KYC Procedures or another regulatory purposes (other than for tax purposes) and that was implemented by the Reporting Financial Institution prior to the date used to classify the Financial Account as a Pre-existing Account, provided that the Reporting Financial Institution does not know or does not have reason to know that such classification is incorrect or unreliable. The term “standardised industry coding system” means a coding system used to classify establishments by business type for purposes other than tax purposes
customs legislation means customs legislation as defined in point 2 of Article 5 of Regulation (EU) No 952/2013 of the European Parliament and of the Council
agricultural legislation means the body of provisions adopted under the common agricultural policy and the special rules adopted with regard to goods resulting from the processing of agricultural products
applicant authority means the competent authority of a Member State which makes a request for assistance
requested authority means the competent authority of a Member State to which a request for assistance is made
administrative enquiry means all controls, checks and other action taken by the staff of the administrative authorities specified in Article 1 (1) in the performance of their duties with a view to ensuring proper application of customs and agricultural legislation and, where necessary, checking the irregular nature of operations which appear to breach that legislation, except action taken at the request of or under a direct mandate from a judicial authority; the expression ‘administrative enquiry’ also covers the Community missions referred to in Article 20
personal data means all information relating to an identified or identifiable individual; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, psychological, mental, economic, cultural or social identity
operational analysis means analysis of operations which constitute, or appear to constitute, breaches of customs or agricultural legislation, involving the following stages in turn:
(a) the collection of information, including personal data;
(b) evaluation of the reliability of the information source and the information itself;
(c) research, methodical presentation and interpretation of links between these items of information or between them and other significant data;
(d) the formulation of observations, hypotheses or recommendations directly usable as risk information by the competent authorities and by the Commission to prevent and detect other operations in breach of customs and agricultural legislation and/or to identify with precision the person or businesses implicated in such operations
strategic analysis means research and presentation of the general trends in breaches of customs and agricultural legislation through an evaluation of the threat, scale and impact of certain types of operation in breach of customs and agricultural legislation, with a view to subsequently setting priorities, gaining a better picture of the phenomenon or threat, reorienting action to prevent and detect fraud and reviewing departmental organisation. Only data from which identifying factors have been removed may be used for strategic analysis
regular automatic exchange means the systematic communication of predefined information, without prior request, at pre-established regular intervals
occasional automatic exchange means the systematic communication of predefined information, without prior request, as and when that information becomes available
customs territory of the Union means the customs territory of the Union as defined in Article 4 of Regulation (EU) No 952/2013
carriers means the persons within the meaning of point 40 of Article 5 of Regulation (EU) No 952/2013
substance means any chemical element and its compounds, with the exception of the following substances:
(a) radioactive substances as defined in Article 1 of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation;
(b) genetically modified micro-organisms as defined in Article 2(b) of Directive 2009/41/EC of the European Parliament and the Council of 6 May 2009 on the contained use of genetically modified micro-organisms;
(c) genetically modified organisms as defined in point 2 of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms
pollution means the direct or indirect introduction, as a result of human activity, of substances, vibrations, heat or noise into air, water or land which may be harmful to human health or the quality of the environment, result in damage to material property, or impair or interfere with amenities and other legitimate uses of the environment
installation means a stationary technical unit within which one or more activities listed in Annex I or in Part 1 of Annex VII are carried out, and any other directly associated activities on the same site which have a technical connection with the activities listed in those Annexes and which could have an effect on emissions and pollution
emission means the direct or indirect release of substances, vibrations, heat or noise from individual or diffuse sources in the installation into air, water or land
emission limit value means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during one or more periods of time
environmental quality standard means the set of requirements which must be fulfilled at a given time by a given environment or particular part thereof, as set out in Union law
permit means a written authorisation to operate all or part of an installation or combustion plant, waste incineration plant or waste co-incineration plant
general binding rules means emission limit values or other conditions, at least at sector level, that are adopted with the intention of being used directly to set permit conditions
substantial change means a change in the nature or functioning, or an extension, of an installation or combustion plant, waste incineration plant or waste co-incineration plant which may have significant negative effects on human health or the environment
best available techniques means the most effective and advanced stage in the development of activities and their methods of operation which indicates the practical suitability of particular techniques for providing the basis for emission limit values and other permit conditions designed to prevent and, where that is not practicable, to reduce emissions and the impact on the environment as a whole:
(a) ‘techniques’ includes both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;
(b) ‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;
(c) ‘best’ means most effective in achieving a high general level of protection of the environment as a whole
BAT reference document means a document, resulting from the exchange of information organised pursuant to Article 13, drawn up for defined activities and describing, in particular, applied techniques, present emissions and consumption levels, techniques considered for the determination of best available techniques as well as BAT conclusions and any emerging techniques, giving special consideration to the criteria listed in Annex III
BAT conclusions means a document containing the parts of a BAT reference document laying down the conclusions on best available techniques, their description, information to assess their applicability, the emission levels associated with the best available techniques, associated monitoring, associated consumption levels and, where appropriate, relevant site remediation measures
emission levels associated with the best available techniques means the range of emission levels obtained under normal operating conditions using a best available technique or a combination of best available techniques, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions
emerging technique means a novel technique for an industrial activity that, if commercially developed, could provide either a higher general level of protection of the environment or at least the same level of protection of the environment and higher cost savings than existing best available techniques
operator means any natural or legal person who operates or controls in whole or in part the installation or combustion plant, waste incineration plant or waste co-incineration plant or, where this is provided for in national law, to whom decisive economic power over the technical functioning of the installation or plant has been delegated
the public means one or more natural or legal persons and, in accordance with national law or practice, their associations, organisations or groups
the public concerned means the public affected or likely to be affected by, or having an interest in, the taking of a decision on the granting or the updating of a permit or of permit conditions; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest
hazardous substances means substances or mixtures as defined in Article 3 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures
baseline report means information on the state of soil and groundwater contamination by relevant hazardous substances
groundwater means groundwater as defined in point 2 of Article 2 of Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
soil means the top layer of the Earth’s crust situated between the bedrock and the surface. The soil is composed of mineral particles, organic matter, water, air and living organisms
environmental inspection means all actions, including site visits, monitoring of emissions and checks of internal reports and follow-up documents, verification of self-monitoring, checking of the techniques used and adequacy of the environment management of the installation, undertaken by or on behalf of the competent authority to check and promote compliance of installations with their permit conditions and, where necessary, to monitor their environmental impact
poultry means poultry as defined in point 1 of Article 2 of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs
fuel means any solid, liquid or gaseous combustible material
combustion plant means any technical apparatus in which fuels are oxidised in order to use the heat thus generated
stack means a structure containing one or more flues providing a passage for waste gases in order to discharge them into the air
operating hours means the time, expressed in hours, during which a combustion plant, in whole or in part, is operating and discharging emissions into the air, excluding start-up and shut-down periods
rate of desulphurisation means the ratio over a given period of time of the quantity of sulphur which is not emitted into air by a combustion plant to the quantity of sulphur contained in the solid fuel which is introduced into the combustion plant facilities and which is used in the plant over the same period of time
indigenous solid fuel means a naturally occurring solid fuel fired in a combustion plant specifically designed for that fuel and extracted locally
determinative fuel means the fuel which, amongst all fuels used in a multi-fuel firing combustion plant using the distillation and conversion residues from the refining of crude-oil for own consumption, alone or with other fuels, has the highest emission limit value as set out in Part 1 of Annex V, or, in the case of several fuels having the same emission limit value, the fuel having the highest thermal input amongst those fuels
biomass means any of the following:
(a) products consisting of any vegetable matter from agriculture or forestry which can be used as a fuel for the purpose of recovering its energy content;
(b) the following waste: (i) vegetable waste from agriculture and forestry; (ii) vegetable waste from the food processing industry, if the heat generated is recovered; (iii) fibrous vegetable waste from virgin pulp production and from production of paper from pulp, if it is co-incinerated at the place of production and the heat generated is recovered; (iv) cork waste; (v) wood waste with the exception of wood waste which may contain halogenated organic compounds or heavy metals as a result of treatment with wood preservatives or coating and which includes, in particular, such wood waste originating from construction and demolition waste
multi-fuel firing combustion plant means any combustion plant which may be fired simultaneously or alternately by two or more types of fuel
gas turbine means any rotating machine which converts thermal energy into mechanical work, consisting mainly of a compressor, a thermal device in which fuel is oxidised in order to heat the working fluid, and a turbine
gas engine means an internal combustion engine which operates according to the Otto cycle and uses spark ignition or, in case of dual fuel engines, compression ignition to burn fuel
diesel engine means an internal combustion engine which operates according to the diesel cycle and uses compression ignition to burn fuel
small isolated system means a small isolated system as defined in point 26 of Article 2 of Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity
waste means waste as defined in point 1 of Article 3 of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste
hazardous waste means hazardous waste as defined in point 2 of Article 3 of Directive 2008/98/EC
mixed municipal waste means waste from households as well as commercial, industrial and institutional waste which, because of its nature and composition, is similar to waste from households, but excluding fractions indicated under heading 20 01 of the Annex to Decision 2000/532/EC that are collected separately at source and excluding the other waste indicated under heading 20 02 of that Annex
waste incineration plant means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste, with or without recovery of the combustion heat generated, through the incineration by oxidation of waste as well as other thermal treatment processes, such as pyrolysis, gasification or plasma process, if the substances resulting from the treatment are subsequently incinerated
waste co-incineration plant means any stationary or mobile technical unit whose main purpose is the generation of energy or production of material products and which uses waste as a regular or additional fuel or in which waste is thermally treated for the purpose of disposal through the incineration by oxidation of waste as well as other thermal treatment processes, such as pyrolysis, gasification or plasma process, if the substances resulting from the treatment are subsequently incinerated
nominal capacity means the sum of the incineration capacities of the furnaces of which a waste incineration plant or a waste co-incineration plant is composed, as specified by the constructor and confirmed by the operator, with due account being taken of the calorific value of the waste, expressed as the quantity of waste incinerated per hour
dioxins and furans means all polychlorinated dibenzo-p-dioxins and dibenzofurans listed in Part 2 of Annex VI
organic compound means any compound containing at least the element carbon and one or more of hydrogen, halogens, oxygen, sulphur, phosphorus, silicon or nitrogen, with the exception of carbon oxides and inorganic carbonates and bicarbonates
volatile organic compound means any organic compound as well as the fraction of creosote, having at 293,15 K a vapour pressure of 0,01 kPa or more, or having a corresponding volatility under the particular conditions of use
organic solvent means any volatile organic compound which is used for any of the following: (a) alone or in combination with other agents, and without undergoing a chemical change, to dissolve raw materials, products or waste materials; (b) as a cleaning agent to dissolve contaminants; (c) as a dissolver; (d) as a dispersion medium; (e) as a viscosity adjuster; (f) as a surface tension adjuster; (g) as a plasticiser; (h) as a preservative
coating means coating as defined in point 8 of Article 2 of Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products
residue shall mean any liquid or solid waste which is generated by a waste incineration plant or waste co-incineration plant
existing installation means an installation in operation on 29 March 1999 or which was granted a permit or registered before 1 April 2001 or the operator of which submitted a complete application for a permit before 1 April 2001, provided that that installation was put in operation no later than 1 April 2002
waste gases means the final gaseous discharge containing volatile organic compounds or other pollutants from a stack or abatement equipment into air
fugitive emissions means any emissions not in waste gases of volatile organic compounds into air, soil and water as well as solvents contained in any products, unless otherwise stated in Part 2 of Annex VII
total emissions means the sum of fugitive emissions and emissions in waste gases
mixture means mixture as defined in Article 3(2) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency
adhesive means any mixture, including all the organic solvents or mixtures containing organic solvents necessary for its proper application, which is used to adhere separate parts of a product
ink means a mixture, including all the organic solvents or mixtures containing organic solvents necessary for its proper application, which is used in a printing activity to impress text or images on to a surface
varnish means a transparent coating
consumption means the total input of organic solvents into an installation per calendar year, or any other 12-month period, less any volatile organic compounds that are recovered for re-use
input means the quantity of organic solvents and their quantity in mixtures used when carrying out an activity, including the solvents recycled inside and outside the installation, and which are counted every time they are used to carry out the activity
re-use means the use of organic solvents recovered from an installation for any technical or commercial purpose and including use as a fuel but excluding the final disposal of such recovered organic solvent as waste
contained conditions means conditions under which an installation is operated so that the volatile organic compounds released from the activity are collected and discharged in a controlled way either via a stack or abatement equipment and are, therefore, not entirely fugitive
start-up and shut-down operations means operations excluding regularly oscillating activity phases whilst bringing an activity, an equipment item or a tank into or out of service or into or out of an idling state
existing waste incineration plant means one of the following waste incineration plants: (i) which was in operation and had a permit in accordance with applicable Union law before 28 December 2002, (ii) which was authorised or registered for waste incineration and had a permit granted before 28 December 2002 in accordance with applicable Union law, provided that the plant was put into operation no later than 28 December 2003, (iii) which, in the view of the competent authority, was the subject of a full request for authorisation before 28 December 2002, provided that the plant was put into operation not later than 28 December 2004
new waste incineration plant means any waste incineration plant not covered by point (a)
ro-ro passenger ship means a ship carrying more than 12 passengers, having ro-ro cargo spaces or special category spaces, as defined in Regulation II-2/3 of the SOLAS Convention, as amended
new ship means a ship the keel of which is laid or which is at a similar stage of construction on or after 1 October 2004: a similar stage of construction means the stage at which: (i) construction identifiable with a specific ship begins; and (ii) assembly of that ship has commenced comprising at least 50 tonnes or 1% of the estimated mass of structural material, whichever is less
an existing ship means a ship which is not a new ship
a passenger is every person other than the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship and other than a child under one year of age
international Conventions means the 1974 International Convention for the Safety of Life at Sea (the SOLAS Convention), and the 1966 International Convention on Load Lines, together with Protocols and amendments thereto in force
regular service means a series of ro-ro passenger ship crossings serving traffic between the same two or more ports, which is operated either: (i) according to a published timetable; or (ii) with crossings so regular or frequent that they constitute a recognisable systematic series
Stockholm Agreement means the Agreement concluded at Stockholm on 28 February 1996 in pursuance of SOLAS 95 Conference Resolution 14 ‘Regional agreements on specific stability requirements for ro-ro passenger ships’, adopted on 29 November 1995
administration of flag State means the competent authorities of the State whose flag the ro-ro passenger ship is entitled to fly
host State means a Member State to or from whose ports a ro-ro passenger ship is engaged on a regular service
international voyage means a sea voyage from a port of a Member State to a port outside that Member State, or vice versa
specific stability requirements means the stability requirements set out in Annex I
significant wave height (‘hs’) is the average height of the highest third of wave heights observed over a given period
residual freeboard (‘fr’) is the minimum distance between the damaged ro-ro deck and the final waterline at the location of the damage, without taking into account the additional effect of the sea water accumulated on the damaged ro-ro deck
‘Community’ and ‘territory of the Community’ mean the territories of the Member States as defined in point (2)
‘Member State’ and ‘territory of a Member State’ mean the territory of each Member State of the Community to which the Treaty establishing the European Community is applicable, in accordance with Article 299 of that Treaty, with the exception of any territory referred to in Article 6 of this Directive
third territories means those territories referred to in Article 6
third country means any State or territory to which the Treaty is not applicable
open market value For the purposes of this Directive, ‘open market value’ shall mean the full amount that, in order to obtain the goods or services in question at that time, a customer at the same marketing stage at which the supply of goods or services takes place, would have to pay, under conditions of fair competition, to a supplier at arm's length within the territory of the Member State in which the supply is subject to tax.
Where no comparable supply of goods or services can be ascertained, ‘open market value’ shall mean the following: (1) in respect of goods, an amount that is not less than the purchase price of the goods or of similar goods or, in the absence of a purchase price, the cost price, determined at the time of supply; (2) in respect of services, an amount that is not less than the full cost to the taxable person of providing the service.
electronic invoice For the purposes of this Directive, ‘electronic invoice’ means an invoice that contains the information required in this Directive, and which has been issued and received in any electronic format
storage of an invoice by electronic means For the purposes of this Chapter, ‘storage of an invoice by electronic means’ shall mean storage of data using electronic equipment for processing (including digital compression) and storage, and employing wire, radio, optical or other electromagnetic means
farmer means any taxable person whose activity is carried out in an agricultural, forestry or fisheries undertaking
agricultural, forestry or fisheries undertaking means an undertaking regarded as such by each Member State within the framework of the production activities listed in Annex VII
flat-rate farmer means any farmer covered by the flat-rate scheme provided for in this Chapter
agricultural products means goods produced by an agricultural, forestry or fisheries undertaking in each Member State as a result of the activities listed in Annex VII
agricultural services means services, and in particular those listed in Annex VIII, supplied by a farmer using his labour force or the equipment normally employed in the agricultural, forestry or fisheries undertaking operated by him and normally playing a part in agricultural production
input VAT charged means the amount of the total VAT attaching to the goods and services purchased by all agricultural, forestry and fisheries undertakings of each Member State subject to the flat-rate scheme where such tax would be deductible in accordance with Articles 167, 168 and 169 and Articles 173 to 177 by a farmer subject to the normal VAT arrangements
flat-rate compensation percentages means the percentages fixed by Member States in accordance with Articles 297, 298 and 299 and applied by them in the cases specified in Article 300 in order to enable flat-rate farmers to offset at a fixed rate the input VAT charged
flat-rate compensation means the amount arrived at by applying the flat-rate compensation percentage to the turnover of the flat-rate farmer in the cases specified in Article 300
second-hand goods means movable tangible property that is suitable for further use as it is or after repair, other than works of art, collectors' items or antiques and other than precious metals or precious stones as defined by the Member States
works of art means the objects listed in Annex IX, Part A
collectors’ items means the objects listed in Annex IX, Part B
antiques means the objects listed in Annex IX, Part C
taxable dealer means any taxable person who, in the course of his economic activity and with a view to resale, purchases, or applies for the purposes of his business, or imports, second-hand goods, works of art, collectors' items or antiques, whether that taxable person is acting for himself or on behalf of another person pursuant to a contract under which commission is payable on purchase or sale
organiser of a sale by public auction means any taxable person who, in the course of his economic activity, offers goods for sale by public auction with a view to handing them over to the highest bidder
principal of an organiser of a sale by public auction means any person who transmits goods to an organiser of a sale by public auction pursuant to a contract under which commission is payable on a sale
selling price means everything which constitutes the consideration obtained or to be obtained by the taxable dealer from the customer or from a third party, including subsidies directly linked to the transaction, taxes, duties, levies and charges and incidental expenses such as commission, packaging, transport and insurance costs charged by the taxable dealer to the customer, but excluding the amounts referred to in Article 79
purchase price means everything which constitutes the consideration, for the purposes of point (1), obtained or to be obtained from the taxable dealer by his supplier
‘telecommunications services’ and ‘broadcasting services’ mean the services referred to in points (a) and (b) of the first paragraph of Article 58
‘electronic services’ and ‘electronically supplied services’ mean the services referred to in point (c) of the first paragraph of Article 58
Member State of consumption means the Member State in which the supply of the telecommunications, broadcasting or electronic services is deemed to take place according to Article 58
VAT return means the statement containing the information necessary to establish the amount of VAT due in each Member State
taxable person not established within the Community means a taxable person who has not established his business in the territory of the Community and who has no fixed establishment there and who is not otherwise required to be identified for VAT purposes
Member State of identification means the Member State which the taxable person not established within the Community chooses to contact to state when his activity as a taxable person within the territory of the Community commences in accordance with the provisions of this Section
taxable person not established in the Member State of consumption means a taxable person who has established his business in the territory of the Community or has a fixed establishment there but has not established his business and has no fixed establishment within the territory of the Member State of consumption
Member State of identification means the Member State in the territory of which the taxable person has established his business or, if he has not established his business in the Community, where he has a fixed establishment
Community means the territory of the Community as defined in point (1) of Article 5 before the accession of new Member States
new Member States means the territory of the Member States which acceded to the European Union after 1 January 1995, as defined for each of those Member States in point (2) of Article 5
enlarged Community means the territory of the Community as defined in point (1) of Article 5 after the accession of new Member States
borrowing costs means interest expenses on all forms of debt, other costs economically equivalent to interest and expenses incurred in connection with the raising of finance as defined in national law, including, without being limited to, payments under profit participating loans, imputed interest on instruments such as convertible bonds and zero coupon bonds, amounts under alternative financing arrangements, such as Islamic finance, the finance cost element of finance lease payments, capitalised interest included in the balance sheet value of a related asset, or the amortisation of capitalised interest, amounts measured by reference to a funding return under transfer pricing rules where applicable, notional interest amounts under derivative instruments or hedging arrangements related to an entity's borrowings, certain foreign exchange gains and losses on borrowings and instruments connected with the raising of finance, guarantee fees for financing arrangements, arrangement fees and similar costs related to the borrowing of funds
exceeding borrowing costs means the amount by which the deductible borrowing costs of a taxpayer exceed taxable interest revenues and other economically equivalent taxable revenues that the taxpayer receives according to national law
tax period means a tax year, calendar year or any other appropriate period for tax purposes
associated enterprise means:
(a) an entity in which the taxpayer holds directly or indirectly a participation in terms of voting rights or capital ownership of 25 percent or more or is entitled to receive 25 percent or more of the profits of that entity;
(b) an individual or entity which holds directly or indirectly a participation in terms of voting rights or capital ownership in a taxpayer of 25 percent or more or is entitled to receive 25 percent or more of the profits of the taxpayer;
If an individual or entity holds directly or indirectly a participation of 25 percent or more in a taxpayer and one or more entities, all the entities concerned, including the taxpayer, shall also be regarded as associated enterprises.
For the purposes of Articles 9 and 9a:
(a) Where the mismatch outcome arises under points (b), (c), (d), (e) or (g) of the first subparagraph of point (9) of this Article or where an adjustment is required under Article 9(3) or Article 9a, the definition of associated enterprise is modified so that the 25 per cent requirement is replaced by a 50 per cent requirement;
(b) a person who acts together with another person in respect of the voting rights or capital ownership of an entity shall be treated as holding a participation in all of the voting rights or capital ownership of that entity that are held by the other person;
(c) an associated enterprise also means an entity that is part of the same consolidated group for financial accounting purposes as the taxpayer, an enterprise in which the taxpayer has a significant influence in the management or an enterprise that has a significant influence in the management of the taxpayer
financial undertaking means any of the following entities:
(a) a credit institution or an investment firm as defined in point (1) of Article 4(1) of Directive 2004/39/EC of the European Parliament and of the Council or an alternative investment fund manager (AIFM) as defined in point (b) of Article 4(1) of Directive 2011/61/EU of the European Parliament and of the Council or an undertaking for collective investment in transferable securities (UCITS) management company as defined in point (b) of Article 2(1) of Directive 2009/65/EC of the European Parliament and of the Council;
(b) an insurance undertaking as defined in point (1) of Article 13 of Directive 2009/138/EC of the European Parliament and of the Council;
(c) a reinsurance undertaking as defined in point (4) of Article 13 of Directive 2009/138/EC;
(d) an institution for occupational retirement provision falling within the scope of Directive 2003/41/EC of the European Parliament and of the Council, unless a Member State has chosen not to apply that Directive in whole or in part to that institution in accordance with Article 5 of that Directive or the delegate of an institution for occupational retirement provision as referred to in Article 19(1) of that Directive;
(e) pension institutions operating pension schemes which are considered to be social security schemes covered by Regulation (EC) No 883/2004 of the European Parliament and of the Council and Regulation (EC) No 987/2009 of the European Parliament and of the Council as well as any legal entity set up for the purpose of investment of such schemes;
(f) an alternative investment fund (AIF) managed by an AIFM as defined in point (b) of Article 4(1) of Directive 2011/61/EU or an AIF supervised under the applicable national law;
(g) UCITS in the meaning of Article 1(2) of Directive 2009/65/EC;
(h) a central counterparty as defined in point (1) of Article 2 of Regulation (EU) No 648/2012 of the European Parliament and of the Council;
(i) a central securities depository as defined in point (1) of Article 2(1) of Regulation (EU) No 909/2014 of the European Parliament and of the Council
переміщення активів означає операцію, внаслідок якої держава-член втрачає право оподатковувати переміщені активи, тоді як активи залишаються під юридичним або економічним правом власності одного й того ж платника податків
transfer of tax residence means an operation whereby a taxpayer ceases to be resident for tax purposes in a Member State, whilst acquiring tax residence in another Member State or third country
transfer of a business carried on by a permanent establishment means an operation whereby a taxpayer ceases to have taxable presence in a Member State whilst acquiring such presence in another Member State or third country without becoming resident for tax purposes in that Member State or third country
hybrid mismatch means a situation involving a taxpayer or, with respect to Article 9(3), an entity where:
(a) a payment under a financial instrument gives rise to a deduction without inclusion outcome and: (i) such payment is not included within a reasonable period of time; and (ii) the mismatch outcome is attributable to differences in the characterisation of the instrument or the payment made under it.
For the purposes of the first subparagraph, a payment under a financial instrument shall be treated as included in income within a reasonable period of time where: (i) the payment is included by the jurisdiction of the payee in a tax period that commences within 12 months of the end of the payer's tax period; or (ii) it is reasonable to expect that the payment will be included by the jurisdiction of the payee in a future tax period and the terms of payment are those that would be expected to be agreed between independent enterprises; (b) a payment to a hybrid entity gives rise to a deduction without inclusion and that mismatch outcome is the result of differences in the allocation of payments made to the hybrid entity under the laws of the jurisdiction where the hybrid entity is established or registered and the jurisdiction of any person with a participation in that hybrid entity; (c) a payment to an entity with one or more permanent establishments gives rise to a deduction without inclusion and that mismatch outcome is the result of differences in the allocation of payments between the head office and permanent establishment or between two or more permanent establishments of the same entity under the laws of the jurisdictions where the entity operates; (d) a payment gives rise to a deduction without inclusion as a result of a payment to a disregarded permanent establishment; (e) a payment by a hybrid entity gives rise to a deduction without inclusion and that mismatch is the result of the fact that the payment is disregarded under the laws of the payee jurisdiction; (f) a deemed payment between the head office and permanent establishment or between two or more permanent establishments gives rise to a deduction without inclusion and that mismatch is the result of the fact that the payment is disregarded under the laws of the payee jurisdiction; or (g) a double deduction outcome occurs.
For the purposes of this point (9): (a) a payment representing the underlying return on a transferred financial instrument shall not give rise to a hybrid mismatch under point (a) of the first subparagraph where the payment is made by a financial trader under an on-market hybrid transfer provided the payer jurisdiction requires the financial trader to include as income all amounts received in relation to the transferred financial instrument; (b) a hybrid mismatch shall only arise under points (e), (f) or (g) of the first subparagraph to the extent that the payer jurisdiction allows the deduction to be set off against an amount that is not dual-inclusion income; (c) a mismatch outcome shall not be treated as a hybrid mismatch unless it arises between associated enterprises, between a taxpayer and an associated enterprise, between the head office and permanent establishment, between two or more permanent establishments of the same entity or under a structured arrangement
population shall mean the national, regional and local population at its usual residence at the reference date
housing shall mean living quarters and buildings as well as housing arrangements and the relationship between the population and living quarters at the national, regional and local levels at the reference date
buildings shall mean permanent buildings that contain living quarters designed for human habitation, or conventional dwellings that are reserved for seasonal or secondary use or that are vacant
usual residence shall mean the place where a person normally spends the daily period of rest, regardless of temporary absences for purposes of recreation, holidays, visits to friends and relatives, business, medical treatment or religious pilgrimage.
The following persons alone shall be considered to be usual residents of the geographical area in question: (i) those who have lived in their place of usual residence for a continuous period of at least 12 months before the reference date; or (ii) those who arrived in their place of usual residence during the 12 months before the reference date with the intention of staying there for at least one year.
Where the circumstances described in point (i) or (ii) cannot be established, ‘usual residence’ shall mean the place of legal or registered residence
reference date shall mean the date to which the data of the respective Member State refer, in accordance with Article 5(1)
national shall mean on the territory of a Member State
regional shall mean at NUTS level 1, NUTS level 2 or NUTS level 3, as defined in the classification of territorial units for statistics (NUTS), established by Regulation (EC) No 1059/2003 of the European Parliament and of the Council in its version applicable at the reference date
local shall mean at Local Administrative Units level 2 (LAU level 2)
essential features of population and housing censuses shall mean individual enumeration, simultaneity, universality within a defined territory, availability of small-area data and defined periodicity
total population of a well defined geographical area means all persons whose usual residence, as defined in Article 2(d) of Regulation (EC) No 763/2008, is located in that geographical area
hypercube means a multidimensional cross tabulation of breakdowns which contains a cell value for the measurement of each category of each breakdown cross-tabulated by each category of any other breakdown used in that hypercube
principal marginal distribution means a subset of a given hypercube which results from the cross tabulation of some but not all of the breakdowns of the hypercube
primary cell means any cell which is part of at least one principal marginal distribution in a given hypercube. In hypercubes for which no principal marginal distribution is defined all cells are primary cells
secondary cell means a hypercube cell that is not a primary cell in a given hypercube
cell value means the information transmitted in a hypercube cell. A cell value can be either a ‘numerical cell value’ or a ‘special cell value’
numerical cell value means a numerical value that is transmitted in a cell in order to provide the statistical information on the observation for that cell
confidential cell value means a numerical cell value which must not be disclosed to protect the statistical confidentiality of the data according to the Member States’ statistical disclosure control
non-confidential cell value means a numerical cell value which is not a confidential cell value
unreliable cell value means a numerical cell value which is unreliable according to the Member States’ quality control
special cell value means a symbol that is transmitted in a hypercube cell instead of a numerical cell value
flag means a code that can accompany a particular cell value to describe a specific characteristic of that cell value
textile product means any raw, semi-worked, worked, semi-manufactured, manufactured, semi-made-up or made-up product which is exclusively composed of textile fibres, regardless of the mixing or assembly process employed
textile fibre means either of the following: (i) a unit of matter characterised by its flexibility, fineness and high ratio of length to maximum transverse dimension, which render it suitable for textile applications; (ii) a flexible strip or tube, of which the apparent width does not exceed 5 mm, including strips cut from wider strips or films, produced from the substances used for the manufacture of the fibres listed in Table 2 of Annex I and suitable for textile applications
apparent width means the width of the strip or tube when folded, flattened, compressed or twisted, or the average width where the width is not uniform
textile component means a part of a textile product with an identifiable fibre content
extraneous fibres means fibres other than those stated on the label or marking
lining means a separate component used in making up garments and other products, consisting of a single layer or multiple layers of textile material held in place along one or more of the edges
labelling means affixing the required information to the textile product by way of attaching a label
inclusive labelling means the use of a single label for several textile products or components
marking means indicating the required information directly on the textile product by way of sewing, embroidering, printing, embossing or any other technology of application
disposable product means a textile product designed to be used only once or for a limited time, and the normal use of which is not intended for subsequent use for the same or a similar purpose
agreed allowance means the value of moisture regain to be used in the calculation of the percentage of fibre components on a clean, dry mass basis, with adjustment by conventional factors
bulk source The quantity of material which is assessed on the basis of one series of test results. This may comprise, for example, all the material in one delivery of cloth; all the cloth woven from a particular beam; a consignment of yarn, a bale or a group of bales of raw fibre.
laboratory bulk sample The portion of the bulk source taken to be representative of the whole, and which is available to the laboratory. The size and nature of the laboratory bulk sample shall be sufficient to adequately overcome the variability of the bulk source and to facilitate ease of handling in the laboratory.
laboratory test sample That portion of the laboratory bulk sample that is subjected to pre-treatment to remove non-fibrous matter, and from which test specimens are taken. The size and nature of the laboratory test sample shall be sufficient to overcome adequately the variability of the laboratory bulk sample.
test specimen The portion of material required to give an individual test result, and selected from the laboratory test sample.
sales denomination means the name of any of the aromatised wine products laid down in this Regulation
description means the list of the specific characteristics of an aromatised wine product
geographical indication means an indication which identifies an aromatised wine product as originating in a region, a specific place, or a country, where a given quality, reputation or other characteristics of that product is essentially attributable to its geographical origin
alcoholic strength by volume means the ratio of the volume of pure alcohol contained in the product in question at a temperature of 20 °C to the total volume of that product at the same temperature
actual alcoholic strength by volume means the number of volumes of pure alcohol contained at a temperature of 20 °C in 100 volumes of the product at that temperature
potential alcoholic strength by volume means the number of volumes of pure alcohol at a temperature of 20 °C capable of being produced by total fermentation of the sugars contained in 100 volumes of the product at the same temperature
total alcoholic strength by volume means the sum of the actual and potential alcoholic strengths by volume
order includes all input messages, including messages on submission, modification and cancellation sent to the trading system of a trading venue, relating to an order or a quote, but excluding cancellation messages sent subsequent to: (i) uncrossing in an auction; (ii) a loss of venue connectivity; (iii) the use of a kill functionality
transaction means a totally or partially executed order
volume means the quantity of financial instruments traded expressed as any of the following: (i) the number of instruments for shares, depositary receipts, ETFs, certificates and other similar financial instruments; (ii) the nominal value for bonds and structured finance products; (iii) the number of lots size or contracts for derivatives; (iv) metric tonnes of carbon dioxide for emission allowances
tobacco means leaves and other natural processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco
pipe tobacco means tobacco that can be consumed via a combustion process and exclusively intended for use in a pipe
roll-your-own tobacco means tobacco which can be used for making cigarettes by consumers or retail outlets
tobacco products means products that can be consumed and consist, even partly, of tobacco, whether genetically modified or not
smokeless tobacco product means a tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use
chewing tobacco means a smokeless tobacco product exclusively intended for the purpose of chewing
nasal tobacco means a smokeless tobacco product that can be consumed via the nose
tobacco for oral use means all tobacco products for oral use, except those intended to be inhaled or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets
tobacco products for smoking means tobacco products other than a smokeless tobacco product
cigarette means a roll of tobacco that can be consumed via a combustion process and is further defined in Article 3(1) of Council Directive 2011/64/EU
cigar means a roll of tobacco that can be consumed via a combustion process and is further defined in Article 4(1) of Directive 2011/64/EU
cigarillo means a small type of cigar and is further defined in Article 8(1) of Council Directive 2007/74/EC
waterpipe tobacco means a tobacco product that can be consumed via a waterpipe. For the purpose of this Directive, waterpipe tobacco is deemed to be a tobacco product for smoking. If a product can be used both via waterpipes and as roll-your-own tobacco, it shall be deemed to be roll-your-own tobacco
novel tobacco product means a tobacco product which: (a) does not fall into any of the following categories: cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use; and (b) is placed on the market after 19 May 2014
herbal product for smoking means a product based on plants, herbs or fruits which contains no tobacco and that can be consumed via a combustion process
electronic cigarette means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges
refill container means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette
ingredient means tobacco, an additive, as well as any substance or element present in a finished tobacco product or related products, including paper, filter, ink, capsules and adhesives
nicotine means nicotinic alkaloids
tar means the raw anhydrous nicotine-free condensate of smoke
emissions means substances that are released when a tobacco or related product is consumed as intended, such as substances found in smoke, or substances released during the process of using smokeless tobacco products
‘maximum level’ or ‘maximum emission level’ means the maximum content or emission, including zero, of a substance in a tobacco product measured in milligrams
additive means a substance, other than tobacco, that is added to a tobacco product, a unit packet or to any outside packaging
flavouring means an additive that imparts smell and/or taste
characterising flavour means a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla, which is noticeable before or during the consumption of the tobacco product
addictiveness means the pharmacological potential of a substance to cause addiction, a state which affects an individual's ability to control his or her behaviour, typically by instilling a reward or a relief from withdrawal symptoms, or both
toxicity means the degree to which a substance can cause harmful effects in the human organism, including effects occurring over time, usually through repeated or continuous consumption or exposure
substantial change of circumstances means an increase of the sales volumes by product category by at least 10 % in at least five Member States based on sales data transmitted in accordance with Article 5(6) or an increase of the level of prevalence of use in the under 25 years of age consumer group by at least five percentage points in at least five Member States for the respective product category based on the Special Eurobarometer 385 report of May 2012 or equivalent prevalence studies; in any case, a substantial change of circumstances is deemed not to have occurred if the sales volume of the product category at retail level does not exceed 2,5 % of total sales of tobacco products at Union level
outside packaging means any packaging in which tobacco or related products are placed on the market and which includes a unit packet or an aggregation of unit packets; transparent wrappers are not regarded as outside packaging
unit packet means the smallest individual packaging of a tobacco or related product that is placed on the market
pouch means a unit packet of roll-your own tobacco, either in the form of a rectangular pocket with a flap that covers the opening or in the form of a standing pouch
health warning means a warning concerning the adverse effects on human health of a product or other undesired consequences of its consumption, including text warnings, combined health warnings, general warnings and information messages, as provided for in this Directive
combined health warning means a health warning consisting of a combination of a text warning and a corresponding photograph or illustration, as provided for in this Directive
cross-border distance sales means distance sales to consumers where, at the time the consumer orders the product from a retail outlet, the consumer is located in a Member State other than the Member State or the third country where that retail outlet is established; a retail outlet is deemed to be established in a Member State: (a) in the case of a natural person: if he or she has his or her place of business in that Member State; (b) in other cases: if the retail outlet has its statutory seat, central administration or place of business, including a branch, agency or any other establishment, in that Member State
consumer means a natural person who is acting for purposes which are outside his or her trade, business, craft or profession
age verification system means a computing system that unambiguously confirms the consumer's age electronically in accordance with national requirements
manufacturer means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark
import of tobacco or related products means the entry into the territory of the Union of such products unless the products are placed under a customs suspensive procedure or arrangement upon their entry into the Union, as well as their release from a customs suspensive procedure or arrangement
importer of tobacco or related products means the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the territory of the Union
placing on the market means to make products, irrespective of their place of manufacture, available to consumers located in the Union, with or without payment, including by means of distance sale; in the case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located
retail outlet means any outlet where tobacco products are placed on the market including by a natural person
inland waterway means a waterway other than the sea, open to navigation by craft referred to in Article 2
craft means a vessel or item of floating equipment
tug means a vessel specially built to perform towing operations
vessel means an inland waterway vessel or seagoing ship
pusher means a vessel specially built to propel a pushed convoy
passenger vessel means a vessel constructed and equipped to carry more than 12 passengers
Union certificate of qualification means a certificate, issued by a competent authority, attesting that a person fulfils the requirements of this Directive
STCW Convention means ‘STCW Convention’ as defined in Article 1(21) of Directive 2008/106/EC of the European Parliament and of the Council
deck crew members means persons who are involved in the general operation of a craft navigating on Union inland waterways and who carry out various tasks, such as tasks related to navigation, controlling the operation of the craft, cargo handling, stowage, passenger transport, marine engineering, maintenance and repair, communication, health and safety, and environmental protection, other than persons who are solely assigned to the operation of the engines, cranes, or electrical and electronic equipment
radio operator’s certificate means a national certificate, issued by a Member State in accordance with the Radio Regulations annexed to the International Telecommunication Convention, authorising the operation of a radio-communication station on an inland waterway craft
passenger navigation expert means a person serving on board the vessel who is qualified to take measures in emergency situations on board passenger vessels
експерт зі зрідженого природного газу означає особу, яка має відповідну кваліфікацію, щоб брати участь в процедурі бункерування плавучого засобу, що працює на зрідженому природному газі, або щоб керувати таким плавучим засобом як капітан
boatmaster means a deck crew member who is qualified to sail a craft on the Member States’ inland waterways and is qualified to have overall responsibility on board, including for the crew, for the passengers and for the cargo
specific risk means a safety hazard that is due to particular navigation conditions which require boatmasters to have competences beyond what is expected under the general standards of competence for the management level
competence means the proven ability to use the knowledge and skills required by the established standards for the proper performance of the tasks necessary for the operation of inland waterway craft
management level means the level of responsibility associated with serving as boatmaster and with ensuring that other deck crew members properly perform all tasks in the operation of a craft
operational level means the level of responsibility associated with serving as boatman, as able boatman or as helmsman and with maintaining control over the performance of all tasks within that person’s designated area of responsibility in accordance with proper procedures and under the direction of a person serving at management level
large convoy means a pushed convoy for which the product of the total length and the total width of the pushed craft is 7 000 square metres or more
service record book means a personal register that records details of a crew member’s work history, in particular navigation time and journeys carried out
logbook means an official record of the journeys made by a craft and its crew
‘active service record book’ or ‘active logbook’ means a service record book or logbook which is open for recording data
navigation time means the time, measured in days, that deck crew members have spent aboard during a journey on a craft on inland waterways, including loading and unloading activities that require active navigational operations, which has been validated by the competent authority
floating equipment means a floating installation carrying working gear such as cranes, dredging equipment, pile drivers or elevators
length means the maximum length of the hull in metres, excluding rudder and bowsprit
breadth means the maximum breadth of the hull in metres, measured to the outer edge of the shell plating (excluding paddle wheels, rub rail, and similar)
draught means the vertical distance in metres between the lowest point of the hull without taking into account the keel or other fixed attachments and the maximum draught line
seasonal navigation means a navigating activity which is exercised for not more than six months each year
exceptional event means any unplanned event that is not reasonably controllable or preventable and that may cause, for a limited period, capacity reductions, affecting thereby the quantity or quality of gas at a given interconnection point, with possible consequences on interactions between transmission system operators as well as between transmission system operator and network users
initiating transmission system operator means the transmission system operator initiating the matching process by sending the necessary data to the matching transmission system operator
lesser rule means that, in case of different processed quantities at either side of an interconnection point, the confirmed quantity will be equal to the lower of the two processed quantities
matching process is the process of comparing and aligning processed quantities of gas for network users at both sides of a specific interconnection point, which results in confirmed quantities for the network users
matching transmission system operator means the transmission system operator performing the matching process and sending the result of the matching process to the initiating transmission system operator
measured quantity means the quantity of gas that, according to the measurement equipment from the transmission system operator, has physically flowed across an interconnection point per time period
operational balancing account means an account between adjacent transmission system operators, to be used to manage steering differences at an interconnection point in order to simplify gas accounting for network users involved at the interconnection point
processed quantity means the quantity of gas determined by the initiating transmission system operator and by the matching transmission system operator, which takes into account the network user's nomination or re-nomination and contractual provisions as defined under the relevant transport contract and which is used as the basis for the matching process
steering difference means the difference between the quantity of gas that the transmission system operators had scheduled to flow and the measured quantity for an interconnection point
gas day means the period from 5:00 to 5:00 UTC the following day for winter time and from 4:00 to 4:00 UTC the following day when daylight saving is applied
interconnection agreement means an agreement entered into by adjacent transmission system operators, whose systems are connected at a particular interconnection point, which specifies terms and conditions, operating procedures and provisions, in respect of delivery and/or withdrawal of gas at the interconnection point with the purpose of facilitating efficient interoperability of the interconnected transmission networks
interconnection point means a physical or virtual point connecting adjacent entry-exit systems or connecting an entry-exit system with an interconnector, in so far as these points are subject to booking procedures by network users
virtual interconnection point means two or more interconnection points which connect the same two adjacent entry-exit systems, integrated together for the purposes of providing a single capacity service
confirmed quantity means the quantity of gas confirmed by a transmission system operator to be scheduled or re-scheduled to flow on gas day D
allocation means the quantity of gas attributed to a network user by a transmission system operator as an input or an off-take expressed in kWh for the purpose of determining the daily imbalance quantity
re-nomination cycle means the process carried out by the transmission system operator in order to provide a network user with the message regarding the confirmed quantities following the receipt of a re-nomination
incremental capacity means a possible future increase via market-based procedures in technical capacity or possible new capacity created where none currently exists that may be offered based on investment in physical infrastructure or long-term capacity optimisation and subsequently allocated subject to the positive outcome of an economic test, in the following cases:
(a) at existing interconnection points;
(b) by establishing a new interconnection point or points;
(c) as physical reverse flow capacity at an interconnection point or points, which has not been offered before
interconnection point means a physical or virtual point connecting adjacent entry-exit systems or connecting an entry-exit system with an interconnector, in so far as these points are subject to booking procedures by network users
alternative allocation mechanism means an allocation mechanism for offer level or incremental capacity designed on a case-by-case basis by the transmission system operators, and approved by the national regulatory authorities, to accommodate conditional demand requests
standard capacity product means a certain amount of transport capacity over a given period of time, at a specified interconnection point
offer level means the sum of the available capacity and the respective level of incremental capacity offered for each of the yearly standard capacity products at an interconnection point
implicit allocation method means a capacity allocation method where, possibly by means of an auction, both transmission capacity and a corresponding quantity of gas are allocated at the same time
bidding round means the period of time during which network users can submit, amend and withdraw bids
large price step means a fixed or variable amount that is defined per interconnection point and standard capacity product
incremental capacity project means a project to increase the amount of technical capacity at an existing interconnection point or to establish a new interconnection point based on capacity allocation in the preceding incremental capacity process
economic test means a test applied to assess the economic viability of incremental capacity projects
incremental capacity process means a process to assess the market demand for incremental capacity that includes a non-binding phase, in which network users express and quantify their demand for incremental capacity, and a binding phase, in which binding commitments for contracting capacity are requested from network users by one or more transmission system operators
bundled capacity means a standard capacity product offered on a firm basis which consists of corresponding entry and exit capacity at both sides of every interconnection point
interconnection agreement means an agreement entered into by adjacent transmission system operators, whose systems are connected at a particular interconnection point, which specifies terms and conditions, operating procedures and provisions, in respect of delivery and/or withdrawal of gas at the interconnection point with the purpose of facilitating efficient interoperability of the interconnected transmission networks, as set out in Chapter II of Regulation (EU) 2015/703
competing capacities means capacities for which the available capacity at one point of the network cannot be allocated without fully or partly reducing the available capacity at another point of the network
auction calendar means a table displaying information relating to specific auctions which is published by ENTSOG <…> every calendar year for auctions taking place during the period of March until February of the following calendar year and consisting of all relevant timings for auctions, including starting dates and standard capacity products to which they apply
gas day means the period from 5.00 to 5.00 UTC the following day for winter time and from 4.00 to 4.00 UTC the following day when daylight saving is applied
within-day capacity means capacity offered and allocated after the closure of the day-ahead capacity auctions with respect to that day
ascending clock auction means an auction in which a network user places requested quantities against defined price steps, which are announced sequentially
uniform-price auction means an auction in which the network user in a single bidding round bids price as well as quantity and all network users, who are successful in gaining capacity, pay the price of the lowest successful bid
reserve price means the eligible floor price in the auction
small price step means a fixed or variable amount that is defined per interconnection point and standard capacity product which is smaller than the large price step
first-time undersell means an occurrence where the aggregate demand across all network users is less than the capacity offered at the end of the second bidding round or a subsequent bidding round
virtual interconnection point means two or more interconnection points which connect the same two adjacent entry-exit systems, integrated together for the purposes of providing a single capacity service
f-factor means the share of the present value of the estimated increase in the allowed or target revenue of the transmission system operator associated with the incremental capacity included in the respective offer level as set out in Article 22(1)(b) to be covered by the present value of binding commitments of network users for contracting capacity calculated as set out in Article 22(1)(a)
over-nomination means the entitlement of network users who fulfil minimum requirements for submitting nominations to request interruptible capacity at any time within-day by submitting a nomination which increases the total of their nominations to a level higher than their contracted capacity
protected customers means all household customers who is connected to a gas distribution network and, in addition, where the Contracting Party concerned so decides, may also mean one or more of the following, provided that enterprises or services as referred to in points (a) and (b) do not, jointly, represent more than 20 % of the total annual final gas consumption in that Contracting Party
(a) small and medium-sized enterprises, provided that they are connected to a gas distribution network; (b) an essential social service, provided that it is connected to a gas distribution or transmission network; (b) a district heating installation to the extent that it delivers heating to household customers, small or medium-sized enterprises, or essential social services, provided that such installation is not able to switch to other fuels than gas.
reference price means the price for a capacity product for firm capacity with a duration of one year,
which is applicable at entry and exit points and which is used to set capacity-based transmission tariffs
reference price methodology means the methodology applied to the part of the transmission services revenue to be recovered from capacity-based transmission tariffs with the aim of deriving reference prices
non-price cap regime means a regulatory regime, such as the revenue cap, rate of return and cost plus regime, under which the allowed revenue for the transmission system operator is set in accordance with Article 41(6)(a) of Directive 2009/73/EC
non-transmission services revenue means the part of the allowed or target revenue which is recovered by non-transmission tariffs
regulatory period means the time period for which the general rules for the allowed or target revenue are set in accordance with Article 41(6)(a) of Directive 2009/73/EC
transmission services revenue means the part of the allowed or target revenue which is recovered by transmission tariffs
transmission tariffs means the charges payable by network users for transmission services provided to them
intra-system network use means transporting gas within an entry-exit system to customers connected to that same entry-exit system
cross-system network use means transporting gas within an entry-exit system to customers connected to another entry-exit system
homogeneous group of points means a group of one of the following types of points: entry interconnection points, exit interconnection points, domestic entry points, domestic exit points, entry points from storage facilities, exit points to storage facilities, entry points from liquefied natural gas facilities (hereinafter, referred to as ‘LNG facilities’), exit points to LNG facilities and entry points from production facilities
allowed revenue means the sum of transmission services revenue and non-transmission services revenue for the provision of services by the transmission system operator for a specific time period within a given regulatory period which such transmission system operator is entitled to obtain under a non-price cap regime and which is set in accordance with Article 41(6)(a) of Directive 2009/73/EC
transmission services means the regulated services that are provided by the transmission system operator within the entry-exit system for the purpose of transmission
non-transmission tariffs means the charges payable by network users for non-transmission services provided to them
target revenue means the sum of expected transmission services revenue calculated in accordance with the principles set out in Article 13(1) of Regulation (EC) No 715/2009 and expected non-transmission services revenue for the provision of services by the transmission system operator for a specific time period within a given regulatory period under a price cap regime
non-transmission services means the regulated services other than transmission services and other than services related to the balancing of the transmission network that are provided by the transmission system operator
multiplier means the factor applied to the respective proportion of the reference price in order to calculate the reserve price for a non-yearly standard capacity product
price cap regime means a regulatory regime under which a maximum transmission tariff based on the target revenue is set in accordance with Article 41(6)(a) of Directive 2009/73/EC
cost driver means a key determinant of the transmission system operator’s activity which is correlated to the costs of that transmission system operator, such as distance or technical capacity
cluster of entry or exit points means a homogeneous group of points or group of entry points or of exit points located within the vicinity of each other and which are considered as, respectively, one entry point or one exit point for the application of the reference price methodology
flow scenario means a combination of an entry point and an exit point which reflects the use of the transmission system according to likely supply and demand patterns and for which there is at least one pipeline route allowing to flow gas into the transmission network at that entry point and out of the transmission network at that exit point, irrespective of whether the capacity is contracted at that entry point and that exit point
seasonal factor means the factor reflecting the variation of demand within the year which may be applied in combination with the relevant multiplier
fixed payable price means a price calculated in accordance with Article 24(b) where the reserve price is not subject to any adjustments
tariff period means the time period during which a particular level of reference price is applicable, which minimum duration is one year and maximum duration is the duration of the regulatory period
regulatory account means the account aggregating at least under- and over-recovery of the transmission services revenue under a non-price cap regime
auction premium means the difference between the clearing price and the reserve price in an auction
floating payable price means a price calculated in accordance with Article 24(a) where the reserve price is subject to adjustments such as revenue reconciliation, adjustment of the allowed revenue or adjustment of the forecasted contracted capacity
balancing zone means an entry-exit system to which a specific balancing regime is applicable and which may include distribution systems or part of them
balancing action means an action undertaken by the transmission system operator to change the gas flows onto or off the transmission network, excluding those actions related to gas unaccounted for as off-taken from the system and gas used by the transmission system operator for the operation of the system
neutrality charge for balancing means a charge amounting to the difference between the amounts received or receivable and the amounts paid or payable by the transmission system operator due to performance of its balancing activities which is payable to or recoverable from the relevant network users
trading platform means an electronic platform provided and operated by a trading platform operator by means of which trading participants may post and accept, including the right to revise and withdraw, bids and offers for gas required to meet short term fluctuations in gas demand or supply, in accordance with the terms and conditions applicable on the trading platform and at which the transmission system operator trades for the purpose of undertaking balancing actions
trading participant means a network user or a transmission system operator holding a contract with the trading platform operator and satisfying the conditions necessary to transact on the trading platform
balancing platform means a trading platform where a transmission system operator is a trading participant to all trades
balancing service means a service provided to a transmission system operator via a contract for gas required to meet short term fluctuations in gas demand or supply, which is not a short term standardised product
confirmed quantity means the quantity of gas confirmed by a transmission system operator to be scheduled or re-scheduled to flow on gas day D
daily imbalance charge means the amount of money a network user pays or receives in respect of a daily imbalance quantity
daily metered means that the gas quantity is measured and collected once per gas day
intraday metered means that the gas quantity is measured and collected a minimum of two times within the gas day
non daily metered means that the gas quantity is measured and collected less frequently than once per gas day
balancing portfolio means a grouping of a network user’s inputs and off-takes
notification quantity means the quantity of gas transferred between a transmission system operator and a network user or network users or balancing portfolios, as appropriate
allocation means the quantity of gas attributed to a network user by a transmission system operator as an input or an off-take expressed in kWh for the purpose of determining the daily imbalance quantity
re-nomination cycle means the process carried out by the transmission system operator in order to provide a network user with the message regarding the confirmed quantities following the receipt of a re-nomination
within day charge means a charge levied or a payment made by a transmission system operator on or to a network user as a result of a within day obligation
within day obligation means a set of rules regarding network users’ inputs and off-takes within the gas day imposed by a transmission system operator on network users
base case means the model for information provision where the information on non daily metered off-takes consists of a day ahead and within day forecasts
variant 1 means the model for information provision where the information on non daily metered and daily metered off-takes is based on apportionment of measured flows during the gas day
variant 2 means the model for information provision where the information on non daily metered off-takes is a day ahead forecast
Union’s financial interests means all revenues, expenditure and assets covered by, acquired through, or due to:
(i) the Union budget;
(ii) the budgets of the Union institutions, bodies, offices and agencies established pursuant to the Treaties or budgets directly or indirectly managed and monitored by them
legal person means an entity having legal personality under the applicable law, except for States or public bodies in the exercise of State authority and for public international organisations
passive corruption means the action of a public official who, directly or through an intermediary, requests or receives advantages of any kind, for himself or for a third party, or accepts a promise of such an advantage, to act or to refrain from acting in accordance with his duty or in the exercise of his functions in a way which damages or is likely to damage the Union's financial interests
active corruption means the action of a person who promises, offers or gives, directly or through an intermediary, an advantage of any kind to a public official for himself or for a third party for him to act or to refrain from acting in accordance with his duty or in the exercise of his functions in a way which damages or is likely to damage the Union's financial interests
misappropriation means the action of a public official who is directly or indirectly entrusted with the management of funds or assets to commit or disburse funds or appropriate or use assets contrary to the purpose for which they were intended in any way which damages the Union's financial interests
public official means:
(a) a Union official or a national official, including any national official of another Member State and any national official of a third country:
(i) ‘Union official’ means a person who is:
— an official or other servant engaged under contract by the Union within the meaning of the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (16) (the ‘Staff Regulations’), or
— seconded to the Union by a Member State or by any public or private body, who carries out functions equivalent to those performed by Union officials or other servants.
Without prejudice to the provisions on privileges and immunities contained in Protocols No 3 and No 7, Members of the Union institutions, bodies, offices and agencies, set up in accordance with the Treaties and the staff of such bodies shall be assimilated to Union officials, inasmuch as the Staff Regulations do not apply to them;
(ii) ‘national official’ shall be understood by reference to the definition of ‘official’ or ‘public official’ in the national law of the Member State or third country in which the person in question carries out his or her functions
Union official means a person who is:
— an official or other servant engaged under contract by the Union within the meaning of the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (the ‘Staff Regulations’), or
— seconded to the Union by a Member State or by any public or private body, who carries out functions equivalent to those performed by Union officials or other servants.
Without prejudice to the provisions on privileges and immunities contained in Protocols No 3 and No 7, Members of the Union institutions, bodies, offices and agencies, set up in accordance with the Treaties and the staff of such bodies shall be assimilated to Union officials, inasmuch as the Staff Regulations do not apply to them
national official shall be understood by reference to the definition of ‘official’ or ‘public official’ in the national law of the Member State or third country in which the person in question carries out his or her functions
electronic identification means the process of using person identification data in electronic form uniquely representing either a natural or legal person, or a natural person representing a legal person
electronic identification means means a material and/or immaterial unit containing person identification data and which is used for authentication for an online service
person identification data means a set of data enabling the identity of a natural or legal person, or a natural person representing a legal person to be established
electronic identification scheme means a system for electronic identification under which electronic identification means are issued to natural or legal persons, or natural persons representing legal persons
authentication means an electronic process that enables the electronic identification of a natural or legal person, or the origin and integrity of data in electronic form to be confirmed
relying party means a natural or legal person that relies upon an electronic identification or a trust service
public sector body means a state, regional or local authority, a body governed by public law or an association formed by one or several such authorities or one or several such bodies governed by public law, or a private entity mandated by at least one of those authorities, bodies or associations to provide public services, when acting under such a mandate
body governed by public law means a body defined in point (4) of Article 2(1) of Directive 2014/24/EU of the European Parliament and of the Council
signatory means a natural person who creates an electronic signature
electronic signature means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign
advanced electronic signature means an electronic signature which meets the requirements set out in Article 26
qualified electronic signature means an advanced electronic signature that is created by a qualified electronic signature creation device, and which is based on a qualified certificate for electronic signatures
electronic signature creation data means unique data which is used by the signatory to create an electronic signature
certificate for electronic signature means an electronic attestation which links electronic signature validation data to a natural person and confirms at least the name or the pseudonym of that person
qualified certificate for electronic signature means a certificate for electronic signatures, that is issued by a qualified trust service provider and meets the requirements laid down in Annex I
trust service means an electronic service normally provided for remuneration which consists of:
(a) the creation, verification, and validation of electronic signatures, electronic seals or electronic time stamps, electronic registered delivery services and certificates related to those services, or
(b) the creation, verification and validation of certificates for website authentication; or
(c) the preservation of electronic signatures, seals or certificates related to those services
qualified trust service means a trust service that meets the applicable requirements laid down in this Regulation
conformity assessment body means a body defined in point 13 of Article 2 of Regulation (EC) No 765/2008, which is accredited in accordance with that Regulation as competent to carry out conformity assessment of a qualified trust service provider and the qualified trust services it provides
trust service provider means a natural or a legal person who provides one or more trust services either as a qualified or as a non-qualified trust service provider
qualified trust service provider means a trust service provider who provides one or more qualified trust services and is granted the qualified status by the supervisory body
product means hardware or software, or relevant components of hardware or software, which are intended to be used for the provision of trust services
electronic signature creation device means configured software or hardware used to create an electronic signature
qualified electronic signature creation device means an electronic signature creation device that meets the requirements laid down in Annex II
creator of a seal means a legal person who creates an electronic seal
electronic seal means data in electronic form, which is attached to or logically associated with other data in electronic form to ensure the latter’s origin and integrity
advanced electronic seal means an electronic seal, which meets the requirements set out in Article 36
qualified electronic seal means an advanced electronic seal, which is created by a qualified electronic seal creation device, and that is based on a qualified certificate for electronic seal
electronic seal creation data means unique data, which is used by the creator of the electronic seal to create an electronic seal
certificate for electronic seal means an electronic attestation that links electronic seal validation data to a legal person and confirms the name of that person
qualified certificate for electronic seal means a certificate for an electronic seal, that is issued by a qualified trust service provider and meets the requirements laid down in Annex III
electronic seal creation device means configured software or hardware used to create an electronic seal
qualified electronic seal creation device means an electronic seal creation device that meets mutatis mutandis the requirements laid down in Annex II
electronic time stamp means data in electronic form which binds other data in electronic form to a particular time establishing evidence that the latter data existed at that time
qualified electronic time stamp means an electronic time stamp which meets the requirements laid down in Article 42
electronic document means any content stored in electronic form, in particular text or sound, visual or audiovisual recording
electronic registered delivery service means a service that makes it possible to transmit data between third parties by electronic means and provides evidence relating to the handling of the transmitted data, including proof of sending and receiving the data, and that protects transmitted data against the risk of loss, theft, damage or any unauthorised alterations
qualified electronic registered delivery service means an electronic registered delivery service which meets the requirements laid down in Article 44
certificate for website authentication means an attestation that makes it possible to authenticate a website and links the website to the natural or legal person to whom the certificate is issued
qualified certificate for website authentication means a certificate for website authentication, which is issued by a qualified trust service provider and meets the requirements laid down in Annex IV
validation data means data that is used to validate an electronic signature or an electronic seal
validation data means the process of verifying and confirming that an electronic signature or a seal is valid
ventilation unit (VU) means an electricity driven appliance equipped with at least one impeller, one motor and a casing and intended to replace utilised air by outdoor air in a building or a part of a building
residential ventilation unit (RVU) means a ventilation unit where:
(a) the maximum flow rate does not exceed 250 m3/h;
(b) the maximum flow rate is between 250 and 1 000 m3/h, and the manufacturer declares its intended use as being exclusively for a residential ventilation application
maximum flow rate is the declared maximum air volume flow rate of a ventilation unit that can be achieved with integrated or separately co-supplied controls at standard air conditions (20 °C) and 101 325 Pa, where the unit is installed complete (e.g. including clean filters) and according to the manufacturer's instructions, for ducted RVUs the maximum flow is related to the air flow at 100 Pa of external static pressure difference, and for non-ducted RVUs to the air flow at the lowest achievable total pressure difference to be chosen from a set of values of 10 (minimum)-20-50-100-150-200-250 Pa, whichever is equal or just below the measured pressure difference value
unidirectional ventilation unit (UVU) means a ventilation unit producing an air flow in one direction only, either from indoors to outdoors (exhaust) or from outdoors to indoors (supply), where the mechanically produced air flow is balanced by natural air supply or exhaust
bidirectional ventilation unit (BVU) means a ventilation unit producing an air flow between indoors and outdoors and which is equipped with both exhaust and supply fans
equivalent ventilation unit model means a ventilation unit with the same technical characteristics according to the applicable product information requirements, but placed on the market as a different ventilation unit model by the same manufacturer, authorised representative or importer
specific energy consumption (SEC) (expressed in kWh/(m2.a)) means a coefficient to express the energy consumed for ventilation per m2 heated floor area of a dwelling or building, calculated for RVUs in accordance with Annex VIII
sound power level (LWA) means the casing-radiated A-weighted sound power level expressed in decibels (dB) with reference to the sound power of one picowatt (1 pW), transmitted by the air at reference airflow
multi-speed drive means a fan motor that can be operated at three or more fixed speeds plus zero (‘off’)
variable speed drive (VSD) means an electronic controller, integrated or functioning as one system or as a separate delivery with the motor and the fan, which continuously adapts the electrical power supplied to the motor in order to control the flow rate
heat recovery system (HRS) means the part of a bidirectional ventilation unit equipped with a heat exchanger designed to transfer the heat contained in the (contaminated) exhaust air to the (fresh) supply air
thermal efficiency of a residential HRS (ηt) means the ratio between supply air temperature gain and exhaust air temperature loss, both relative to the outdoor temperature, measured under dry conditions of the HRS, and standard air conditions, with balanced mass flow at reference flow rate, an indoor-outdoor temperature difference of 13 K, no correction for thermal heat gain from fan motors
internal leakage rate means the fraction of extract air present in the supply air of ventilation units with HRS as a result of leakage between extract and supply airflows inside the casing when the unit is operated at reference air volume flow, measured at the ducts, the test shall be performed at 100 Pa
carry over means the percentage of the exhaust air which is returned to the supply air for a regenerative heat exchanger according to the reference flow
external leakage rate means the fraction of reference air volume flow escaping from the casing of a unit when it is subjected to a pressure test, the test shall be performed at 250 Pa for both under and over pressure
mixing means the immediate recirculation or short-circuiting of airflows between discharge and intake ports at both the indoor and outdoor terminals so that they do not contribute to the effective ventilation of a building space, when the unit is operated at reference air volume rate
mixing rate means the fraction of extract airflow, as part of the total reference air volume, that recirculates between discharge and intake ports at both the indoor and outdoor terminals and thus does not contribute to the effective ventilation of a building space, when the unit is operated at reference air volume (measured at 1 m distance from the indoor supply duct), less the internal leakage rate
effective power input (expressed in W) means the electric power input at reference flow rate and corresponding external total pressure difference and includes the electrical demand for fans, controls (including remote controls) and the heat pump (if integrated)
specific power input (SPI) (expressed in W/(m3/h)) means the ratio between the effective power input (in W) and the reference flow rate (in m3/h)
flow rate/pressure diagram means a set of curves for flow rate (horizontal axis) and pressure difference of a unidirectional RVU or the supply side of a bidirectional RVU, where each curve represents one fan speed with at least eight equidistant test-points and the number of curves is given by the number of discrete fan speed options (one, two or three) or, in the case of a variable fan speed drive, includes at least a minimum, maximum and appropriate intermediate curve close to the reference air volume and pressure difference for SPI testing
reference flow rate (expressed in m3/s) is the abscissa value to a point on a curve in the flow rate/pressure diagram which is on or closest to a reference point at 70 % at least of the maximum flow rate and 50 Pa for ducted units and at a minimum pressure for non-ducted units. For bidirectional ventilation units, the reference air volume flow rate applies to the air supply outlet
control factor (CTRL) means a correction factor for the SEC calculation depending on the type of control that is part of the ventilation unit, according to the description in Annex VIII Table 1
control parameter means a measurable parameter or set of measurable parameters that are assumed to be representative of the ventilation demand, e.g. the level of relative humidity (RH), carbon dioxide (CO2), volatile organic compounds (VOC) or other gases, presence, motion or occupancy detection from infrared body heat or from reflection of ultrasonic waves, electrical signals from human operation of lights or equipment
manual control means any control type that does not use demand control
demand control means a device or set of devices, integrated or as a separate delivery, that measures a control parameter and uses the result to regulate automatically the flow rate of the unit and/or the flow rates of the ducts
clock control means a clocked (daytime-controlled) human interface to control the fan speed/flow rate of the ventilation unit, with at least seven weekday manual settings of the adjustable flow rate for at least two setback periods, i.e. periods in which a reduced or no flow rate applies
demand controlled ventilation (DCV) means a ventilation unit that uses demand control
ducted unit means a ventilation unit intended to ventilate one or more rooms or enclosed space in a building through the use of air ducts, intended to be equipped with duct connections
non-ducted unit means a single room ventilation unit intended to ventilate a single room or enclosed space in a building, and not intended to be equipped with duct connections
central demand control means a demand control of a ducted ventilation unit that continuously regulates the fan speed(s) and flow rate based on one sensor for the whole ventilated building or part of the building at central level
local demand control means a demand control for a ventilation unit that continuously regulates the fan speed(s) and flow rates based on more than one sensor for a ducted ventilation unit or one sensor for a non-ducted unit
static pressure (psf) means the total pressure minus the fan dynamic pressure
total pressure (pf) means the difference between the stagnation pressure at the fan outlet and that at the fan inlet
stagnation pressure means the pressure measured at a point in a flowing gas if it were to be brought to rest by means of an isentropic process
dynamic pressure means the pressure calculated from the mass flow rate and the average gas density at the outlet and the unit outlet area
recuperative heat exchanger means a heat exchanger intended to transfer thermal energy from one air stream to another without moving parts, such as a plate or tubular heat exchanger with parallel flow, cross flow or counter flow, or a combination of these, or a plate or tubular heat exchanger with vapour diffusion
regenerative heat exchanger means a rotary heat exchanger incorporating a rotating wheel for the purpose of transferring thermal energy from one air stream to the other, including material allowing latent heat transfer, a drive mechanism, a casing or frame, and seals to reduce bypassing and leakage of air from one stream or another; such heat exchangers have varying degrees of moisture recovery depending on the material used
airflow sensitivity to pressure variations of a non-ducted RVU is the ratio between the maximum deviation from the maximum RVU flow rate at + 20 Pa and that at – 20 Pa external total pressure difference
indoor/outdoor air tightness of a non-ducted RVU is the flow rate (expressed in m3/h) between indoors and outdoors when the fan(s) is(are) switched off
display mechanism means any screen, including tactile screen, or other visual technology used for displaying internet content to users
nested display means a visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set
tactile screen means a screen responding to touch, such as that of a tablet computer, slate computer or smartphone
alternative text means text provided as an alternative to a graphic, allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications
ship means any seagoing vessel, whether publicly or privately owned, which is ordinarily engaged in commercial maritime operations. Fishing vessels are not included in this definition
competent authority means the authorities designated by the Member States to perform functions under this Directive
inspector means a public-sector employee or other person, duly authorised by the competent authority of a Member State to inspect the working conditions on board, and responsible to that competent authority,
complaint means any information or report submitted by a member of the crew, a professional body, an association, a trade union or, generally, any person with an interest in the safety of the ship, including an interest in safety or health hazards to its crew
product shall mean any product — including in the context of providing a service — which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned
safe product shall mean any product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular:
(i) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
(ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products;
(iii) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;
(iv) the categories of consumers at risk when using the product, in particular children and the elderly
dangerous product shall mean any product which does not meet the definition of ‘safe product’ in (b)
serious risk shall mean any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities
producer shall mean:
(i) the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product;
(ii) the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product;
(iii) other professionals in the supply chain, insofar as their activities may affect the safety properties of a product
distributor shall mean any professional in the supply chain whose activity does not affect the safety properties of a product
recall shall mean any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor
withdrawal shall mean any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer
international conventions shall mean the conventions in force on 4 December 2001, as defined in Article 2(1) of Council Directive 95/21/EC
1974 SOLAS Convention shall mean the International Convention for the Safety of Life at Sea, together with the Protocols and amendments thereto, in its up-to-date version
BLU Code shall mean the Code of Practice for the Safe Loading and Unloading of Bulk Carriers, as contained in the Annex to IMO Assembly Resolution A.862(20) of 27 November 1997, as it stands on 4 December 2001
bulk carrier shall bear the meaning given to it in Regulation IX/1.6 of the 1974 SOLAS Convention and interpreted by Resolution 6 of the 1997 SOLAS Conference, namely:
— a ship constructed with single deck, top-side tanks and hopper-side tanks in cargo paces and intended primarily to carry dry cargo in bulk, or
— an ore carrier, meaning a sea-going single deck ship having two longitudinal bulkheads and a double bottom throughout the cargo region and intended for the carriage of ore cargoes in the centre holds only, or
— a combination carrier as defined in Regulation II-2/3.27 of the 1974 SOLAS Convention
dry cargo in bulk or solid bulk cargo shall mean solid bulk cargo as defined in Regulation XII/1.4 of the 1974 SOLAS Convention, excluding grain
grain shall bear the meaning given to it in Regulation VI/8.2 of the 1974 SOLAS Convention
terminal shall mean any fixed, floating or mobile facility equipped and used for the loading or unloading of dry cargo in bulk into or from bulk carriers
terminal operator shall mean the owner of a terminal, or any organisation or person to whom the owner has transferred the responsibility for loading or unloading operations conducted at the terminal for a particular bulk carrier
terminal representative shall mean any person appointed by the terminal operator, who has the overall responsibility for, and authority to, control the preparation, the conduct and the completion of loading or unloading operations conducted by the terminal for a particular bulk carrier
master shall mean the person who has command over a bulk carrier or a ship's officer designated by the master for the loading or unloading operations
recognised organisation shall mean an organisation recognised in accordance with Article 4 of Council Directive 94/57/EC
administration of the flag State shall mean the competent authorities of the State whose flag the bulk carrier is entitled to fly
port State control authority shall mean the competent authority of a Member State empowered to apply the control provisions of Directive 95/21/EC
competent authority shall mean a national, regional or local public authority in the Member State empowered by national legislation to implement and enforce the requirements of this Directive
cargo information shall mean the cargo information required by Regulation VI/2 of the 1974 SOLAS Convention
loading or unloading plan shall mean a plan as referred to in Regulation VI/7.3 of the 1974 SOLAS Convention and having the format as contained in Appendix 2 of the BLU Code
ship/shore safety checklist shall mean the checklist as referred to in section 4 of the BLU Code and having the format as contained in Appendix 3 of the BLU Code
solid bulk cargo density declaration shall mean the information on the density of the cargo to be provided in compliance with Regulation XII/10 of the 1974 SOLAS Convention
cells means individual human cells or a collection of human cells when not bound by any form of connective tissue
tissue means all constituent parts of the human body formed by cells
donor means every human source, whether living or deceased, of human cells or tissues
donation means donating human tissues or cells intended for human applications
organ means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy
procurement means a process by which tissue or cells are made available
processing means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications
preservation means the use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues
quarantine means the status of retrieved tissue or cells, or tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection
storage means maintaining the product under appropriate controlled conditions until distribution
distribution means transportation and delivery of tissues or cells intended for human applications
human application means the use of tissues or cells on or in a human recipient and extracorporal applications
serious adverse event means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity
serious adverse reaction means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity
tissue establishment means a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells
allogeneic use means cells or tissues removed from one person and applied to another
autologous use means cells or tissues removed from and applied in the same person
IMO Code for the Investigation of Marine Casualties and Incidents shall mean the Code for the Investigation of Marine Casualties and Incidents annexed to Resolution A.849(20) of the IMO Assembly of 27 November 1997, in its up-to-date version
serious casualty shall be understood in accordance with the updated definition contained in Circular MSC-MEPC.3/Circ.3 of the IMO Maritime Safety Committee and Marine Environment Protection Committee of 18 December 2008
IMO guidelines on the fair treatment of seafarers in the event of a maritime accident shall mean the guidelines as annexed to Resolution LEG.3(91) of the IMO Legal Committee of 27 April 2006 and as approved by the Governing Body of the International Labour Organisation in its 296th session of 12 to 16 June 2006
ro-ro ferry and high-speed passenger craft shall be understood in accordance with the definitions contained in Article 2 of Directive 1999/35/EC
Voyage data recorder (VDR) shall be understood in accordance with the definition contained in Resolution A.861(20) of the IMO Assembly and Resolution MSC.163(78) of the IMO Maritime Safety Committee
safety recommendation shall mean any proposal made, including for the purposes of registration and control, by:
(a) the investigative body of the State conducting, or leading, the safety investigation on the basis of information derived from that investigation; or, where appropriate,
(b) the Commission, acting on the basis of an abstract data analysis and the results of safety investigations carried out
reporting formalities means the information set out in the Annex which, in accordance with the legislation applicable in a Member State, must be provided for administrative and procedural purposes when a ship arrives in or departs from a port in that Member State
FAL Convention means the IMO Convention on Facilitation of International Maritime Traffic, adopted on 9 April 1965, as amended
FAL forms means the standardised forms, as provided for in the FAL Convention
ship means any seagoing vessel or craft
SafeSeaNet means the Union maritime information exchange system as defined in Directive 2002/59/EC
electronic transmission of data means the process of transmitting information that has been encoded digitally, using a revisable structured format which can be used directly for storage and processing by computers
explosives means the materials and articles considered to be explosives in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations
ammunition means projectiles with or without propelling charges and blank ammunition used in portable firearms, other guns and artillery
safety means the prevention of accidents and, where prevention fails, the containment of their effects
security means the prevention of use contrary to law and order
approval means the decision taken to allow envisaged transfers of explosives within the Union
transfer means any physical movement of explosives within the Union except movements within one and the same site
making available on the market means any supply of an explosive for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of an explosive on the Union market
manufacturer means any natural or legal person who manufactures an explosive or has an explosive designed or manufactured, and markets that explosive under his name or trade mark or uses it for his own purposes
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places an explosive from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an explosive available on the market
economic operators means the manufacturer, the authorised representative, the importer, the distributor and any natural or legal person who engages in the storage, use, transfer, import, export or trade of explosives
dealer means any natural or legal person whose occupation consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of fire arms and ammunition
technical specification means a document that prescribes technical requirements to be fulfilled by an explosive
harmonised standard means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the essential safety requirements of this Directive relating to an explosive have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of an explosive that has already been made available to the end-user
withdrawal means any measure aimed at preventing an explosive in the supply chain from being made available on the market
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
CE marking means a marking by which the manufacturer indicates that the explosive is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
reproductive cells means all tissues and cells intended to be used for the purpose of assisted reproduction
partner donation means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship
direct use means any procedure where cells are donated and used without any banking
quality system means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly
standard operating procedures (SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product
validation (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, SOP, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use
traceability means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells
procurement organisation means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment
hours of work means time during which a seafarer is required to do work on account of the ship
hours of rest means time outside hours of work; this term does not include short breaks
seafarer means any person who is employed or engaged or works in any capacity on board a ship to which this Agreement applies
shipowner means the owner of the ship or another organisation or person, such as the manager, agent or bareboat charterer, who has assumed the responsibility for the operation of the ship from the owner and who, on assuming such responsibility, has agreed to take over the duties and responsibilities imposed on shipowners in accordance with this Agreement, regardless of whether any other organisation or persons fulfil certain of the duties or responsibilities on behalf of the shipowner
heater means a space heater or combination heater
space heater means a device that
(a) provides heat to a water-based central heating system in order to reach and maintain at a desired level the indoor temperature of an enclosed space such as a building, a dwelling or a room; and
(b) is equipped with one or more heat generators
combination heater means a space heater that is designed to also provide heat to deliver hot drinking or sanitary water at given temperature levels, quantities and flow rates during given intervals, and is connected to an external supply of drinking or sanitary water
water-based central heating system means a system using water as a heat transfer medium to distribute centrally generated heat to heat emitters for the space heating of buildings, or parts thereof
heat generator means the part of a heater that generates the heat using one or more of the following processes:
(a) combustion of fossil fuels and/or biomass fuels;
(b) use of the Joule effect in electric resistance heating elements;
(c) capture of ambient heat from an air source, water source or ground source, and/or waste heat; whereby a heat generator designed for a heater and a heater housing to be equipped with such a heat generator shall be also considered a heater
heater housing means the part of a heater designed to have a heat generator fitted
rated heat output (Prated) means the declared heat output of a heater when providing space heating and, if applicable, water heating at standard rating conditions, expressed in kW; for heat pump space heaters and heat pump combination heaters the standard rating conditions for establishing the rated heat output are the reference design conditions, as set out in Annex III, Table 4
standard rating conditions means the operating conditions of heaters under average climate conditions for establishing the rated heat output, seasonal space heating energy efficiency, water heating energy efficiency, sound power level and nitrogen oxide emissions
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
biomass fuel means a gaseous or liquid fuel produced from biomass
fossil fuel means a gaseous or liquid fuel of fossil origin
boiler space heater means a space heater that generates heat using the combustion of fossil fuels and/or biomass fuels, and/or using the Joule effect in electric resistance heating elements
boiler combination heater means a boiler space heater that is designed to also provide heat to deliver hot drinking or sanitary water at given temperature levels, quantities and flow rates during given intervals, and is connected to an external supply of drinking or sanitary water
electric boiler space heater means a boiler space heater that generates heat using the Joule effect in electric resistance heating elements only
electric boiler combination heater means a boiler combination heater that generates heat using the Joule effect in electric resistance heating elements only
cogeneration space heater means a space heater simultaneously generating heat and electricity in a single process
heat pump space heater means a space heater using ambient heat from an air source, water source or ground source, and/or waste heat for heat generation; a heat pump space heater may be equipped with one or more supplementary heaters using the Joule effect in electric resistance heating elements or the combustion of fossil and/or biomass fuels
heat pump combination heater means a heat pump space heater that is designed to also provide heat to deliver hot drinking or sanitary water at given temperature levels, quantities and flow rates during given intervals, and is connected to an external supply of drinking or sanitary water
supplementary heater means a non-preferential heater that generates heat in cases where the heat demand is greater than the rated heat output of the preferential heater
seasonal space heating energy efficiency (ηs ) means the ratio between the space heating demand for a designated heating season, supplied by a heater and the annual energy consumption required to meet this demand, expressed in %
water heating energy efficiency (ηwh ) means the ratio between the useful energy in the drinking or sanitary water provided by a combination heater and the energy required for its generation, expressed in %
sound power level (LWA ) means the A-weighted sound power level, indoors and/or outdoors, expressed in dB
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient is CC = 2,5
standby mode means a condition where the heater is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
standby mode power consumption (PSB ) means the power consumption of a heater in standby mode, expressed in kW
average climate conditions mean the temperature conditions characteristic for the city of Strasbourg
temperature control means the equipment that interfaces with the end-user regarding the values and timing of the desired indoor temperature, and communicates relevant data to an interface of the heater such as a central processing unit, thus helping to regulate the indoor temperature(s)
gross calorific value (GCV) means the total amount of heat released by a unit quantity of fuel when it is burned completely with oxygen and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of any water vapour contained in the fuel and of the water vapour formed by the combustion of any hydrogen contained in the fuel
equivalent model means a model placed on the market with the same technical parameters set out in Table 1 or Table 2 (as applicable) of Annex II, point 5, as another model placed on the market by the same manufacturer
fuel boiler space heater means a boiler space heater that generates heat by burning fossil fuels and/or biomass fuels, and which may be equipped with one or more additional heat generators using the Joule effect in electric resistance heating elements
fuel boiler combination heater means a boiler combination heater that generates heat by burning fossil fuels and/or biomass fuels, and which may be equipped with one or more additional heat generators using the Joule effect in electric resistance heating elements
type B1 boiler means a fuel boiler space heater incorporating a draught diverter, intended to be connected to a natural draught flue that evacuates the residues of combustion to the outside of the room containing the fuel boiler space heater, and drawing the combustion air directly from the room; a type B1 boiler is marketed as type B1 boiler only
type B1 combination boiler means a fuel boiler combination heater incorporating a draught diverter, intended to be connected to a natural draught flue that evacuates the residues of combustion to the outside of the room containing the fuel boiler combination heater, and drawing the combustion air directly from the room; a type B1 combination boiler is marketed as type B1 combination boiler only
seasonal space heating energy efficiency in active mode (ηson ) means
— for fuel boiler space heaters and fuel boiler combination heaters, a weighted average of the useful efficiency at rated heat output and the useful efficiency at 30 % of the rated heat output, expressed in %;
— for electric boiler space heaters and electric boiler combination heaters, the useful efficiency at rated heat output, expressed in %;
— for cogeneration space heaters not equipped with supplementary heaters, the useful efficiency at rated heat output, expressed in %;
— for cogeneration space heaters equipped with supplementary heaters, a weighted average of the useful efficiency at rated heat output with supplementary heater disabled, and the useful efficiency at rated heat output with supplementary heater enabled, expressed in %
useful efficiency (η) means the ratio of the useful heat output and the total energy input of a boiler space heater, boiler combination heater or cogeneration space heater, expressed in %, whereby the total energy input is expressed in terms of GCV and/or in terms of final energy multiplied by CC
useful heat output (P) means the heat output of a boiler space heater, boiler combination heater or cogeneration space heater transmitted to the heat carrier, expressed in kW
electrical efficiency (ηel ) means the ratio of the electricity output and the total energy input of a cogeneration space heater, expressed in %, whereby the total energy input is expressed in terms of GCV and/or in terms of final energy multiplied by CC
ignition burner power consumption (Pign ) means the power consumption of a burner intended to ignite the main burner, expressed in W in terms of GCV
condensing boiler means a boiler space heater or boiler combination heater in which, under normal operating conditions and at given operating water temperatures, the water vapour in the combustion products is partially condensed, in order to make use of the latent heat of this water vapour for heating purposes
auxiliary electricity consumption means the annual electricity required for the designated operation of a boiler space heater, boiler combination heater or cogeneration space heater, calculated from the electric power consumption at full load (elmax), at part load (elmin), in standby mode and default operating hours at each mode, expressed in kWh in terms of final energy
standby heat loss (Pstby ) means the heat loss of a boiler space heater, boiler combination heater or cogeneration space heater in operating modes without heat demand, expressed in kW
outdoor temperature (Tj ) means the dry bulb outdoor air temperature, expressed in degrees Celsius; the relative humidity may be indicated by a corresponding wet bulb temperature
rated coefficient of performance (COPrated) or rated primary energy ratio (PERrated) means the declared capacity for heating, expressed in kW, divided by the energy input, expressed in kW in terms of GCV and/or in kW in terms of final energy multiplied by CC, for heating provided at standard rating conditions
reference design conditions means the combination of the reference design temperature, the maximum bivalent temperature and the maximum operation limit temperature, as set out in Annex III, Table 4
reference design temperature (Tdesignh) means the outdoor temperature, expressed in degrees Celsius, as set out in Annex III, Table 4, at which the part load ratio is equal to 1
part load ratio (pl(Tj )) means the outdoor temperature minus 16 °C divided by the reference design temperature minus 16 °C
heating season means a set of operating conditions describing per bin the combination of outdoor temperatures and the number of hours these temperatures occur per season
bin (binj ) means a combination of an outdoor temperature and bin hours, as set out in Annex III, Table 5
bin hours (Hj ) means the hours per heating season, expressed in hours per year, at which an outdoor temperature occurs for each bin, as set out in Annex III, Table 5
part load for heating (Ph(Tj )) means the heating load at a specific outdoor temperature, calculated as the design load multiplied by the part load ratio and expressed in kW
seasonal coefficient of performance (SCOP) or seasonal primary energy ratio (SPER) is the overall coefficient of performance of a heat pump space heater or heat pump combination heater using electricity or the overall primary energy ratio of a heat pump space heater or heat pump combination heater using fuels, representative of the designated heating season, calculated as the reference annual heating demand divided by the annual energy consumption
reference annual heating demand (QH ) means the reference heating demand for a designated heating season, to be used as the basis for calculating SCOP or SPER and calculated as the product of the design load for heating and the annual equivalent active mode hours, expressed in kWh
annual energy consumption (QHE ) means the energy consumption required to meet the reference annual heating demand for a designated heating season, expressed in kWh in terms of GCV and/or in kWh in terms of the final energy multiplied by CC
annual equivalent active mode hours (HHE) means the assumed annual number of hours a heat pump space heater or heat pump combination heater has to provide the design load for heating to satisfy the reference annual heating demand, expressed in h
active mode coefficient of performance (SCOPon ) or active mode primary energy ratio (SPERon) means the average coefficient of performance of the heat pump space heater or heat pump combination heater using electricity in active mode, or the average primary energy ratio of the heat pump space heater or heat pump combination heater using fuels in active mode for the designated heating season
supplementary capacity for heating (sup(Tj )) means the rated heat output Psup of a supplementary heater that supplements the declared capacity for heating to meet the part load for heating, if the declared capacity for heating is less than the part load for heating, expressed in kW
bin-specific coefficient of performance (COPbin(Tj )) or bin-specific primary energy ratio (PERbin(Tj )) means the coefficient of performance of the heat pump space heater or heat pump combination heater using electricity, or primary energy ratio of the heat pump space heater or heat pump combination heater using fuel specific for every bin in a season, derived from the part load for heating, declared capacity for heating and declared coefficient of performance for specified bins and calculated for other bins by interpolation or extrapolation, corrected where necessary by the degradation coefficient
declared capacity for heating (Pdh(Tj )) means the heating capacity a heat pump space heater or heat pump combination heater is able to deliver, for an outdoor temperature, expressed in kW
capacity control means the ability of a heat pump space heater or heat pump combination heater to change its capacity by changing the volumetric flow rate of at least one of the fluids needed to operate the refrigeration cycle, to be indicated as ‘fixed’ if the volumetric flow rate cannot be changed or ‘variable’ if the volumetric flow rate is changed or varied in series of two or more steps
design load for heating (Pdesignh) means the rated heat output (Prated) of a heat pump space heater or heat pump combination heater at the reference design temperature, whereby the design load for heating is equal to the part load for heating with outdoor temperature equal to reference design temperature, expressed in kW
declared coefficient of performance (COPd(Tj )) or declared primary energy ratio (PERd(Tj )) means the coefficient of performance or primary energy ratio at a limited number of specified bins
bivalent temperature (Tbiv ) means the outdoor temperature declared by the manufacturer for heating at which the declared capacity for heating equals the part load for heating and below which the declared capacity for heating requires supplementary capacity for heating to meet the part load for heating, expressed in degrees Celsius
operation limit temperature (TOL) means the outdoor temperature declared by the manufacturer for heating, below which the air-to-water heat pump space heater or air-to-water heat pump combination heater will not be able to deliver any heating capacity and the declared capacity for heating is equal to zero, expressed in degrees Celsius
heating water operation limit temperature (WTOL) means the outlet water temperature declared by the manufacturer for heating, above which the heat pump space heater or heat pump combination heater will not be able to deliver any heating capacity and the declared capacity for heating is equal to zero, expressed in degrees Celsius
cycling interval capacity for heating (Pcych) means the integrated heating capacity over the cycling test interval for heating, expressed in kW
cycling interval efficiency (COPcyc or PERcyc) means the average coefficient of performance or average primary energy ratio over the cycling test interval, calculated as the integrated heating capacity over the interval, expressed in kWh, divided by the integrated energy input over that same interval, expressed in kWh in terms of GCV and/or in kWh in terms of final energy multiplied by CC
degradation coefficient (Cdh) means the measure of efficiency loss due to cycling of heat pump space heaters or heat pump combination heaters; if Cdh is not determined by measurement then the default degradation coefficient is Cdh = 0,9
active mode means the condition corresponding to the hours with a heating load for the enclosed space and activated heating function; this condition may involve cycling of the heat pump space heater or heat pump combination heater to reach or maintain a required indoor air temperature
off mode means a condition in which the heat pump space heater or heat pump combination heater is connected to the mains power source and is not providing any function, including conditions providing only an indication of off mode condition and conditions providing only functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2004/108/EC of the European Parliament and of the Council
thermostat-off mode means the condition corresponding to the hours with no heating load and activated heating function, whereby the heating function is switched on but the heat pump space heater or heat pump combination heater is not operational; cycling in active mode is not considered as thermostat-off mode
crankcase heater mode means the condition in which a heating device is activated to avoid the refrigerant migrating to the compressor so as to limit the refrigerant concentration in oil when the compressor is started
off mode power consumption (POFF) means the power consumption of a heat pump space heater or heat pump combination heater in off mode, expressed in kW
thermostat-off mode power consumption (PTO ) means the power consumption of the heat pump space heater or heat pump combination heater while in thermostat-off mode, expressed in kW
crankcase heater mode power consumption (PCK ) means the power consumption of the heat pump space heater or heat pump combination heater while in crankcase heater mode, expressed in kW
low-temperature heat pump means a heat pump space heater that is specifically designed for low-temperature application, and that cannot deliver heating water with an outlet temperature of 52 °C at an inlet dry (wet) bulb temperature of – 7 °C (– 8 °C) in the reference design conditions for average climate
low-temperature application means an application where the heat pump space heater delivers its declared capacity for heating at an indoor heat exchanger outlet temperature of 35 °C
medium-temperature application means an application where the heat pump space heater or heat pump combination heater delivers its declared capacity for heating at an indoor heat exchanger outlet temperature of 55 °C
load profile means a given sequence of water draw-offs, as specified in Annex III, Table 7; each combination heater meets at least one load profile
water draw-off means a given combination of useful water flow rate, useful water temperature, useful energy content and peak temperature, as specified in Annex III, Table 7
useful water flow rate (f) means the minimum flow rate, expressed in litres per minute, for which hot water is contributing to the reference energy, as specified in Annex III, Table 7
useful water temperature (Tm ) means the water temperature, expressed in degrees Celsius, at which hot water starts contributing to the reference energy, as specified in Annex III, Table 7
useful energy content (Qtap) means the energy content of hot water, expressed in kWh, provided at a temperature equal to, or above, the useful water temperature, and at water flow rates equal to, or above, the useful water flow rate, as specified in Annex III, Table 7
energy content of hot water means the product of the specific heat capacity of water, the average temperature difference between the hot water output and cold water input, and the total mass of the hot water delivered
peak temperature (Tp ) means the minimum water temperature, expressed in degrees Celsius, to be achieved during water draw-off, as specified in Annex III, Table 7
reference energy (Qref ) means the sum of the useful energy content of water draw-offs, expressed in kWh, in a particular load profile, as specified in Annex III, Table 7
maximum load profile means the load profile with the greatest reference energy that a combination heater is able to provide while fulfilling the temperature and flow rate conditions of that load profile
declared load profile means the load profile applied for conformity assessment
daily electricity consumption (Qelec ) means the consumption of electricity for water heating over 24 consecutive hours under the declared load profile, expressed in kWh in terms of final energy
daily fuel consumption (Qfuel ) means the consumption of fuels for water heating over 24 consecutive hours under the declared load profile, expressed in kWh in terms of GCV
water heater means a device that
(a) is connected to an external supply of drinking or sanitary water;
(b) generates and transfers heat to deliver drinking or sanitary hot water at given temperature levels, quantities and flow rates during given intervals; and
(c) is equipped with one or more heat generators
heat generator means the part of a water heater that generates the heat using one or more of the following processes:
(a) combustion of fossil fuels and/or biomass fuels;
(b) use of the Joule effect in electric resistance heating elements;
(c) capture of ambient heat from an air source, water source or ground source, and/or waste heat;
whereby a heat generator designed for a water heater and a water heater housing to be equipped with such a heat generator shall be also considered a water heater
water heater housing means the part of a water heater designed to have a heat generator fitted
rated heat output means the declared heat output of the water heater when providing water heating at standard rating conditions, expressed in kW
storage volume (V) means the rated volume of a hot water storage tank or a storage water heater, expressed in litres
standard rating conditions means the operating conditions of water heaters for establishing the rated heat output, water heating energy efficiency, sound power level and nitrogen oxide emissions, and of hot water storage tanks for establishing the standing loss
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
biomass fuel means a gaseous or liquid fuel produced from biomass
fossil fuel means a gaseous or liquid fuel of fossil origin
conventional water heater means a water heater that generates heat using the combustion of fossil and/or biomass fuels and/or the Joule effect in electric resistance heating elements
heat pump water heater means a water heater using ambient heat from an air source, water source or ground source, and/or waste heat for heat generation
solar water heater means a water heater equipped with one or more solar collectors, solar hot water storage tanks, heat generators and possibly pumps in the collector loop and other parts; a solar water heater is placed on the market as one unit
hot water storage tank means a vessel for storing hot water for water and/or space heating purposes, including any additives, which is not equipped with any heat generator except possibly one or more back-up immersion heaters
back-up immersion heater means a Joule effect electric resistance heater that is part of a hot water storage tank and generates heat only when the external heat source is disrupted (including during maintenance periods) or out of order, or that is part of a solar hot water storage tank and provides heat when the solar heat source is not sufficient to satisfy required comfort levels
water heating energy efficiency (ηwh ) means the ratio between the useful energy provided by a water heater and the energy required for its generation, expressed in %
sound power level (LWA ) means the A-weighted sound power level, indoors and/or outdoors, expressed in dB
standing loss (S) means the heating power dissipated from a hot water storage tank at given water and ambient temperatures, expressed in W
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient is CC = 2,5
storage water heater means a water heater equipped with hot water storage tank(s), heat generator(s) and possibly other parts, which are contained in a single housing
load profile means a given sequence of water draw-offs, as specified in Annex III, Table 1; each water heater meets at least one load profile
water draw-off means a given combination of useful water flow rate, useful water temperature, useful energy content and peak temperature, as specified in Annex III, Table 1
useful water flow rate (f) means the minimum flow rate, expressed in litres per minute, for which hot water is contributing to the reference energy, as specified in Annex III, Table 1
useful water temperature (Tm ) means the water temperature, expressed in degrees Celsius, at which hot water starts contributing to the reference energy, as specified in Annex III, Table 1
useful energy content (Qtap) means the energy content of hot water, expressed in kWh, provided at a temperature equal to, or above, the useful water temperature, and at water flow rates equal to, or above, the useful water flow rate, as specified in Annex III, Table 1
energy content of hot water means the product of the specific heat capacity of water, the average temperature difference between the hot water output and cold water input, and the total mass of the hot water delivered
peak temperature (Tp ) means the minimum water temperature, expressed in degrees Celsius, to be achieved during water draw-off, as specified in Annex III, Table 1
reference energy (Qref ) means the sum of the useful energy content of water draw-offs, expressed in kWh, in a particular load profile, as specified in Annex III, Table 1
maximum load profile means the load profile with the greatest reference energy that a water heater is able to provide while fulfilling the temperature and flow rate conditions of that load profile
declared load profile means the load profile applied for conformity assessment
daily electricity consumption (Qelec ) means the consumption of electricity over 24 consecutive hours under the declared load profile, expressed in kWh in terms of final energy
daily fuel consumption (Qfuel ) means the consumption of fuels over 24 consecutive hours under the declared load profile, expressed in kWh in terms of GCV
gross calorific value (GCV) means the total amount of heat released by a unit quantity of fuel when it is burned completely with oxygen and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of any water vapour contained in the fuel and of the water vapour formed by the combustion of any hydrogen contained in the fuel
smart control means a device that automatically adapts the water heating process to individual usage conditions with the aim of reducing energy consumption
smart control compliance (smart) means the measure of whether a water heater equipped with smart controls fulfils the criterion set out in point 4 of Annex IV
smart control factor (SCF) means the water heating energy efficiency gain due to smart control under the conditions set out in point 3 of Annex III
weekly electricity consumption with smart controls (Qelec,week,smart) means the weekly electricity consumption of a water heater with the smart control function enabled, measured under the conditions set out in point 3 of Annex III, expressed in kWh in terms of final energy
weekly fuel consumption with smart controls (Qfuel,week,smart) means the weekly fuel consumption of a water heater with the smart control function enabled, measured under the conditions set out in point 3 of Annex III, expressed in kWh in terms of GCV
weekly electricity consumption without smart controls (Qelec,week ) means the weekly electricity consumption of a water heater with the smart control function disabled, measured under the conditions set out in point 3 of Annex III, expressed in kWh in terms of final energy
weekly fuel consumption without smart controls (Qfuel,week ) means the weekly fuel consumption of a water heater with the smart control function disabled, measured under the conditions set out in point 3 of Annex III, expressed in kWh in terms of GCV
ambient correction term (Qcor ) means a term which takes into account the fact that the place where the water heater is installed is not an isothermal place, expressed in kWh
standby heat loss (Pstby ) means the heat loss of a heat pump water heater in operating modes without heat demand, expressed in kW
mixed water at 40 °C (V40) means the quantity of water at 40 °C, which has the same heat content (enthalpy) as the hot water which is delivered above 40 °C at the output of the water heater, expressed in litres
average climate conditions mean the temperature and global solar irradiance conditions characteristic for the city of Strasbourg
annual energy consumption (Qtota ) means the annual energy consumption of a solar water heater, expressed in kWh in terms of primary energy and/or kWh in terms of GCV
annual non-solar heat contribution (Qnonsol ) means the annual contribution of electricity (expressed in kWh in terms of primary energy) and/or fuel (expressed in kWh in terms of GCV) to the useful heat output of a solar water heater, taking into account the annual amount of heat captured by the solar collector and the heat losses of the solar hot water storage tank
solar collector means a device designed to absorb global solar irradiance and to transfer the heat energy so produced to a fluid passing through it; it is characterised by the collector aperture area, the zero-loss efficiency, the first-order coefficient, the second-order coefficient and the incidence angle modifier
global solar irradiance means the rate of total incoming solar energy, both direct and diffuse, on a collector plane with an inclination of 45 degrees and southward orientation at the Earth’s surface, expressed in W/m2
collector aperture area (Asol) means the maximum projected area through which unconcentrated solar radiation enters the collector, expressed in m2
zero-loss efficiency (η0 ) means the efficiency of the solar collector, when the solar collector mean fluid temperature is equal to the ambient temperature
first-order coefficient (a1 ) means the heat loss coefficient of a solar collector, expressed in W/(m2 K)
second-order coefficient (a2) means the coefficient measuring the temperature dependence of the first-order coefficient, expressed in W/(m2 K2)
incidence angle modifier (IAM) means the ratio of the useful heat output of a solar collector at a given incidence angle and its useful heat output at an incidence angle of 0 degrees
incidence angle means the angle between the direction to the sun and the direction perpendicular to the solar collector aperture
solar hot water storage tank means a hot water storage tank storing heat energy produced by one or more solar collectors
heat generator water heating energy efficiency (ηwh,nonsol ) means the water heating energy efficiency of a heat generator which is part of a solar water heater, expressed in %, established under average climate conditions and without using solar heat input
auxiliary electricity consumption (Qaux ) means the annual electricity consumption of a solar water heater that is due to the pump power consumption and the standby power consumption, expressed in kWh in terms of final energy
pump power consumption (solpump) means the rated electrical power consumption of the pump in the collector loop of a solar water heater, expressed in W
standby power consumption (solstandby) means the rated electrical power consumption of a solar water heater when the pump and the heat generator of a solar water heater are inactive, expressed in W
equivalent model means a model placed on the market with the same technical parameters set out in the applicable product information requirements of Annex II as another model placed on the market by the same manufacturer
trimmings means small pieces of meat, falling within the Combined Nomenclature codes listed in Annex XI to Regulation (EU) No 1169/2011, recognised as fit for human consumption and produced exclusively during trimming operations, when boning of carcases or when cutting up of meat
batch means meat, falling within the Combined Nomenclature codes listed in Annex XI to Regulation (EU) No 1169/2011, obtained from a single species, with or without bone, whether or not cut or minced, that has been cut, minced or packed under practically identical conditions
food hygiene, hereinafter called hygiene means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use
primary products means products of primary production including products of the soil, of stock farming, of hunting and fishing
establishment means any unit of a food business
competent authority means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country
equivalent model means, in respect of different systems, capable of meeting the same objectives
contamination means the presence or introduction of a hazard
potable water means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption
clean seawater means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food
clean water means clean seawater and fresh water of a similar quality
wrapping means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself
packaging means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself
hermetically sealed container means a container that is designed and intended to be secure against the entry of hazards
processing means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes
unprocessed products means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed
processed products means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics
food (or foodstuff) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans
food law means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals
food business means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food
food business operator means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control
feed (or feedingstuff) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals
feed business means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on his own holding
feed business operator means the natural or legal persons responsible for ensuring that the requirements of food law are met within the feed business under their control
retail means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets
placing on the market means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves
risk means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard
risk analysis means a process consisting of three interconnected components: risk assessment, risk management and risk communication
risk assessment means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation
risk management means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options
risk communication means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions
hazard means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect
traceability means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution
stages of production, processing and distribution means any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed
primary production means the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products
final consumer means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity
traceability means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa
reporting establishment means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority
recipient means someone who has been transfused with blood or blood components
issue means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient
imputability means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process
facilities means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered
primary smoke condensate shall refer to the purified water-based part of condensed smoke and shall fall within the definition of ‘smoke flavourings’
primary tar fraction shall refer to the purified fraction of the water-insoluble high-density tar phase of condensed smoke and shall fall within the definition of ‘smoke flavourings’
primary products shall refer to primary smoke condensates and primary tar fractions
derived smoke flavourings shall refer to flavourings produced as a result of the further processing of primary products and which are used or intended to be used in or on foods in order to impart smoke flavour to those foods
lift means a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, or a lifting appliance moving along a fixed course even where it does not move along rigid guides
carrier means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered
model lift means a representative lift whose technical documentation shows the way in which the essential health and safety requirements set out in Annex I will be met for lifts which conform to the model lift defined by objective parameters and which uses identical safety components for lifts
making available on the market means any supply of a safety component for lifts for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means:
— the first making available on the market of a safety component for lifts, or
—the supply of a lift for use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
installer means the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift
manufacturer means any natural or legal person who manufactures a safety component for lifts or has a safety component for lifts designed or manufactured, and markets it under his name or trade mark
authorised representative means any natural or legal person established within the Union who has received a written mandate from an installer or a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places a safety component for lifts from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a safety component for lifts available on the market
economic operators means the installer, the manufacturer, the authorised representative, the importer and the distributor
technical specification means a document that prescribes technical requirements to be fulfilled by a lift or a safety component for lifts
harmonised standard means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the essential health and safety requirements of this Directive relating to a lift or a safety component for lifts have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall in relation to a lift means any measure aimed at achieving the dismantling and safe disposal of a lift, and in relation to a safety component for lifts means any measure aimed at achieving the return of a safety component for lifts that has already been made available to the installer or to the end-user
withdrawal means any measure aimed at preventing a safety component for lifts in the supply chain from being made available on the market
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
CE marking means a marking by which the installer or the manufacturer indicates that the lift or safety component for lifts are in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
making available on the market means any supply of a toy for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a toy on the Community market
manufacturer means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark
authorised representative means any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Community who places a toy from a third country on the Community market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
harmonised standard means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive
Community harmonisation legislation means any Community legislation harmonising the conditions for the marketing of products
accreditation shall have the meaning assigned to it by Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether specified requirements relating to a toy have been fulfilled
conformity assessment body means a body that performs conformity assessment activities, including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of a toy that has already been made available to the end user
withdrawal means any measure aimed at preventing a toy in the supply chain from being made available on the market
market surveillance means the activities carried out and measures taken by public authorities to ensure that toys comply with the applicable requirements set out in Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection
CE marking means a marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing
functional product means a product which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation
functional toy means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation
aquatic toy means a toy intended for use in shallow water which is capable of carrying or supporting a child on the water
design speed means representative potential operating speed that is determined by the design of the toy
activity toy means a toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for the performance by a child of any of the following activities: climbing, jumping, swinging, sliding, rocking, spinning, crawling and creeping, or any combination thereof
chemical toy means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult
olfactory board game means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours
cosmetic kit means a toy the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners
gustative game means a toy the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas
harm means physical injury or any other damage to health, including long-term health effects
hazard means a potential source of harm
risk means the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm
intended for use by means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group
solid fuel local space heater means a space heating device that emits heat by direct heat transfer or by direct heat transfer in combination with heat transfer to a fluid, in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated, possibly combined with a heat output to other spaces, and is equipped with one or more heat generators that convert solid fuels directly into heat
open fronted solid fuel local space heater means a solid fuel local space heater of which the fire bed and combustion gases are not sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
closed fronted solid fuel local space heater means a solid fuel local space heater of which the fire bed and combustion gases can be sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
cooker means a solid fuel local space heater, using solid fuels, that integrates in one enclosure the function of a solid fuel local space heater, and a hob an oven or both to be used for preparation of food and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
flueless solid fuel local space heater means a solid fuel local space heater emitting the products of combustion into the space where the product is situated
open to chimney solid fuel local space heater means a solid fuel local space heater intended to sit under a chimney or in a fireplace without sealing between the product and the chimney or fireplace opening, and allowing the products of combustion pass unrestricted from the fire bed to the chimney or flue
sauna stove means a solid fuel local space heater, incorporated in, or declared to be used in, dry or wet sauna's or similar environments
air heating product means a product providing heat to an air-based heating system only that can be ducted and is designed to be used while fastened or secured in a specific location or wall mounted which distributes the air by means of an air moving device in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated
solid fuel means a fuel which is solid at normal indoor room temperatures, including solid biomass and solid fossil fuel
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
woody biomass means biomass originating from trees, bushes and shrubs, including log wood, chipped wood, compressed wood in the form of pellets, compressed wood in the form of briquettes, and sawdust
non-woody biomass means biomass other than woody biomass, including, inter alia, straw, miscanthus, reeds, kernels, grains, olive stones, olive cakes and nut shells
fossil solid fuel means solid fuel other than biomass, including anthracite and dry steam coal, hard coke, low temperature coke, bituminous coal, lignite, a blend of fossil fuels or a blend of biomass and fossil fuel; for the purposes of this Regulation it also includes peat
preferred fuel means the single fuel for which is to be preferably used for the solid fuel local space heater according to the manufacturer's instructions
other suitable fuel means a fuel, other than the preferred fuel, which can be used in the solid fuel local space heater according to the manufacturer's instructions and includes any fuel that is mentioned in the instruction manual for installers and end-users, on free access websites of manufacturers and suppliers, in technical or promotional material and in advertisements
direct heat output means the heat output of the product by radiation and convection of heat, as emitted by or from the product itself to air excluding the heat output of the product to a heat transfer fluid, expressed in kW
indirect heat output means the heat output of the product to a heat transfer fluid by the same heat generation process that provides the direct heat output of the product, expressed in kW
indirect heating functionality means the product is capable of transferring part of the total heat output to a heat transfer fluid, for use as space heating or domestic hot water generation
nominal heat output (Pnom) means the heat output of a solid fuel local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the maximum heat output that can be maintained over an extended period, as declared by the manufacturer, expressed in kW
minimum heat output (Pmin) means the heat output of a solid fuel local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the lowest heat output, as declared by the manufacturer, expressed in kW
intended for outdoor use means the product is suitable for safe operation outside enclosed spaces, including possible use in outdoor conditions
particulate matter means particles of various shape, structure and density scattered in the gaseous phase of the flue gas
equivalent model means a model placed on the market with the same technical parameters set out in Table 1 of point 3 of Annex II as another model placed on the market by the same manufacturer
seasonal space heating energy efficiency (ηs) means the ratio between the space heating demand, supplied by a solid fuel local space heater and the annual energy consumption required to meet this demand, expressed in %
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council ( 1 ); the value of the conversion coefficient is CC = 2,5
particulate matter emissions means the emissions of particulate matter at nominal heat output, expressed in mg/m3 dry flue gas calculated to 273 K and 1 013 mbar at 13 % O2 or the weighted average emission of particulate matter over up to four burn rates, expressed in g/kg, dry matter
carbon monoxide emissions means the emissions of carbon monoxide at nominal heat output, expressed in mg/m3 flue gas calculated to 273 K and 1 013 mbar at 13 % O2
organic gaseous compounds emissions means the emissions of organic gaseous compounds at nominal heat output expressed in mgC/m3 flue gas calculated to 273 K and 1 013 mbar at 13 % O2
nitrogen oxides emissions means the emissions of nitrogen oxides at nominal heat output, expressed in mg/m3 flue gas expressed as NO2 calculated to 273 K and 1 013 mbar at 13 % O2
net calorific value (NCV) means the total amount of heat released by a unit quantity of fuel containing the appropriate moisture of the fuel, when it is burned completely with oxygen, and when the products of combustion are not returned to ambient temperature
useful efficiency, at either nominal or minimum heat output (ηth,nom or ηth,min respectively) means the ratio of the useful heat output and the total energy input expressed in terms of NCV of a solid fuel local space heater, expressed in %
electric power requirement at nominal heat output (elmax) means the electric power consumption of the solid fuel local space heater while providing the nominal heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement at minimum heat output (elmin) means the electric power consumption of the solid fuel local space heater while providing the minimum heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement in standby mode (elsb) means the electric power consumption of the product while in standby mode, expressed in kW
permanent pilot flame power requirement (Ppilot) means the fuel consumption of solid fuel of the product for the provision of a flame to serve as an ignition source for the more powerful combustion process needed for nominal or part load heat output, when lit for more than 5 minutes before the main burner is on, expressed in kW
single stage heat output, no room temperature control means the product is not capable of varying its heat output automatically and that no feedback of room temperature is present to adapt the heat output automatically
two or more manual stages, no room temperature control means the product is capable of varying its heat output manually by two or more levels of heat output and is not equipped with a device that automatically regulates the heat output in relation to a desired indoor temperature
with mechanic thermostat room temperature control means the product is equipped with a non-electronic device that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control plus day timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature level for a 24-hours timer interval
with electronic room temperature control plus week timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature levels for a full week. During the 7-day period the settings must allow a variation on a day-to-day basismeans the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature levels for a full week. During the 7-day period the settings must allow a variation on a day-to-day basis
room temperature control, with presence detection means the product is equipped with an electronic device, either integrated or external, that automatically reduces the set-point for the room temperature when no person is detected in the room
room temperature control, with open window detection means the product is equipped with an electronic device, either integrated or external, that reduces the heat output when a window or door has been opened. Whenever a sensor is used to detect the opening of a window or door, it can be installed with the product, externally to the product, built into the building structure or as a combination of those options
with distance control option means the function that allows remote interaction from outside the building in which the product is installed with the control of the product
single stage means that the product is not capable of automatically varying its heat output
two stage means the product is capable of automatically regulating its heat output in two distinct levels, in relation to the actual indoor air temperature and a desired indoor air temperature, controlled through temperature sensing devices and an interface which is not necessarily integral to the product itself
modulating means the product is capable of automatically regulating its heat output in three or more distinct levels, in relation to the actual indoor air temperature and a desired indoor air temperature, controlled through temperature sensing devices and an interface which is not necessarily integral to the product itself
standby mode means a condition where the product is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
other fossil fuel means fossil fuel other than anthracite and dry steam coal, hard coke, low temperature coke, bituminous coal, lignite, peat or blended fossil fuel briquettes
other woody biomass means woody biomass other than log wood with a moisture content of 25 % or lower, briquetted fuel with a moisture content below 14 % or compressed wood with a moisture content below 12 %
model identifier means the code, usually alphanumeric, which distinguishes a specific solid fuel local space heater model from other models with the same trade mark or manufacturer's name
moisture content means the mass of water in the fuel in relation to the total mass of the fuel as used in the solid fuel local space heater
solid fuel boiler means a device equipped with one or more solid fuel heat generators that provides heat to a water-based central heating system in order to reach and maintain at a desired level the indoor temperature of one or more enclosed spaces, with a heat loss to its surrounding environment of not more than 6 % of rated heat output
water-based central heating system means a system using water as a heat transfer medium to distribute centrally generated heat to heat emitting devices for the heating of enclosed spaces within buildings or parts thereof, including block heating or district heating networks
solid fuel heat generator means the part of a solid fuel boiler that generates the heat through the combustion of solid fuels
rated heat output or Pr means the declared heat output of a solid fuel boiler when providing heating of enclosed spaces with the preferred fuel, expressed in kW
solid fuel means a fuel that is solid at normal indoor room temperatures, including solid biomass and solid fossil fuel
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
woody biomass means biomass originating from trees, bushes and shrubs, including log wood, chipped wood, compressed wood in the form of pellets, compressed wood in the form of briquettes, and sawdust
non-woody biomass means biomass other than woody biomass, including straw, miscanthus, reeds, kernels, grains, olive stones, olive cakes and nut shells
fossil fuel means fuel other than biomass, including anthracite, brown coal, coke, bituminous coal; for the purposes of this Regulation it also includes peat
biomass boiler means a solid fuel boiler that uses biomass as the preferred fuel
non-woody biomass boiler means a biomass boiler that uses non-woody biomass as the preferred fuel and for which woody biomass, fossil fuel or a blend of biomass and fossil fuel are not listed among its other suitable fuels
preferred fuel means the single solid fuel which is to be preferably used for the boiler according to the manufacturer's instructions
other suitable fuel means a solid fuel, other than the preferred fuel, which can be used in the solid fuel boiler according to the manufacturer's instructions and includes any fuel that is mentioned in the instruction manual for installers and end-users, on free access websites of manufacturers, in technical promotional material and in advertisements
solid fuel cogeneration boiler means a solid fuel boiler capable of simultaneously generating heat and electricity
seasonal space heating energy efficiency or ηs means the ratio between the space heating demand for a designated heating season supplied by a solid fuel boiler and the annual energy consumption required to meet that demand, expressed in %
particulate matter means particles of various shape, structure and density scattered in the gaseous phase of the flue gas
seasonal space heating emissions means:
(a) for automatically stoked solid fuel boilers, a weighted average of the emissions at rated heat output and the emissions at 30 % of the rated heat output, expressed in mg/m3;
(b) for manually stoked solid fuel boilers that can be operated at 50 % of the rated heat output in continuous mode, a weighted average of the emissions at rated heat output and the emissions at 50 % of the rated heat output, expressed in mg/m3;
(c) for manually stoked solid fuel boilers that cannot be operated at 50 % or less of the rated heat output in continuous mode, the emissions at rated heat output, expressed in mg/m3;
(d) for solid fuel cogeneration boilers, the emissions at rated heat output, expressed in mg/m3
fossil fuel boiler means a solid fuel boiler that has fossil fuel or a blend of biomass and fossil fuel as preferred fuel
solid fuel boiler housing means the part of a solid fuel boiler designed for fitting a solid fuel heat generator
model identifier means the code, usually alphanumeric, which distinguishes a specific solid fuel boiler model from other models with the same trade mark or manufacturer's name
condensing boiler means a solid fuel boiler in which, under normal operating conditions and at given operating water temperatures, the water vapour in the combustion products is partially condensed, in order to make use of the latent heat of this water vapour for heating purposes
combination boiler means a solid fuel boiler that is designed to also provide heat to deliver hot drinking or sanitary water at given temperature levels, quantities and flow rates during given intervals, and is connected to an external supply of drinking or sanitary water
other woody biomass means woody biomass other than: log wood with a moisture content of 25 % or less, chipped wood with a moisture content of 15 % or higher, compressed wood in the form of pellets or briquettes, or sawdust with a moisture content equal to or less than 50 %
moisture content means the mass of water in the fuel in relation to the total mass of the fuel as used in solid fuel boilers
other fossil fuel means fossil fuel other than bituminous coal, brown coal (including briquettes), coke, anthracite or blended fossil fuel briquettes
electrical efficiency or ηel means the ratio of the electricity output and the total energy input of a solid fuel cogeneration boiler, expressed in %, whereby the total energy input is expressed in terms of GCV or in terms of final energy multiplied by CC
gross calorific value or GCV means the total amount of heat released by a unit quantity of fuel containing the appropriate moisture content, when it is burned completely with oxygen, and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of the water vapour formed by the combustion of any hydrogen contained in the fuel
conversion coefficient or CC means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council ( 2 ); the value of the conversion coefficient is CC = 2,5
electric power requirement at maximum heat output or elmax means the electric power consumption of the solid fuel boiler at rated heat output, expressed in kW, excluding electricity consumption from a back-up heater and from incorporated secondary emission abatement equipment
electric power requirement at minimum heat output or elmin means the electric power consumption of the solid fuel boiler at applicable part load, expressed in kW, excluding electricity consumption from a back-up heater and from incorporated secondary emission abatement equipment
back-up heater means a Joule-effect electric resistance element that generates heat only to prevent the solid fuel boiler or the water-based central heating system from freezing or when the external heat source supply is disrupted (including during maintenance periods) or out of order
applicable part load means for automatically stoked solid fuel boilers, operation at 30 % of rated heat output, and for manually stoked solid fuel boilers that can be operated at 50 % of rated heat output, operation at 50 % of rated heat output
standby mode power consumption or PSB means the power consumption of a solid fuel boiler in standby mode, excluding from incorporated secondary emission abatement equipment, expressed in kW
standby mode means a condition where the solid fuel boiler is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, or information or status display
seasonal space heating energy efficiency in active mode or ηson means:
(a) for automatically stoked solid fuel boilers, a weighted average of the useful efficiency at rated heat output and the useful efficiency at 30 % of the rated heat output, expressed in %;
(b) for manually stoked solid fuel boilers that can be operated at 50 % of the rated heat output in continuous mode, a weighted average of the useful efficiency at rated heat output and the useful efficiency at 50 % of the rated heat output, expressed in %;
(c) for manually stoked solid fuel boilers that cannot be operated at 50 % or less of the rated heat output in continuous mode, the useful efficiency at rated heat output, expressed in %;
(d) for solid fuel cogeneration boilers, the useful efficiency at rated heat output, expressed in %
useful efficiency or η means the ratio of the useful heat output and the total energy input of a solid fuel boiler, expressed in %, whereby the total energy input is expressed in terms of GCV or in terms of final energy multiplied by CC
useful heat output or P means the heat output of a solid fuel boiler transmitted to the heat carrier, expressed in kW
temperature control means the equipment that interfaces with the end-user regarding the values and timing of the desired indoor temperature, and communicates relevant data to an interface of the solid fuel boiler such as a central processing unit, thus helping to regulate the indoor temperature(s)
gross calorific value moisture free or GCVmf means the total amount of heat released by a unit quantity of fuel dried of inherent moisture, when it is burned completely with oxygen, and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of the water vapour formed by the combustion of any hydrogen contained in the fuel
equivalent model means a model placed on the market with the same technical parameters set out in Table 1 of point 2 of Annex II as another model placed on the market by the same manufacturer
groundwater means all water which is below the surface of the ground in the saturation zone and in direct contact with the ground or subsoil
freshwater means naturally occurring water having a low concentration of salts, which is often acceptable as suitable for abstraction and treatment to produce drinking water
nitrogen compound means any nitrogen-containing substance except for gaseous molecular nitrogen
livestock means all animals kept for use or profit
fertilizer means any substance containing a nitrogen compound or nitrogen compounds utilized on land to enhance growth of vegetation; it may include livestock manure, the residues from fish farms and sewage sludge
chemical fertilizer means any fertilizer which is manufactured by an industrial process
livestock manure means waste products excreted by livestock or a mixture of litter and waste products excreted by livestock, even in processed form
land application means the addition of materials to land whether by spreading on the surface of the land, injection into the land, placing below the surface of the land or mixing with the surface layers of the land
eutrophication means the enrichment of water by nitrogen compounds, causing an accelerated growth of algae and higher forms of plant life to produce an undesirable disturbance to the balance of organisms present in the water and to the quality of the water concerned
pollution means the discharge, directly or indirectly, of nitrogen compounds from agricultural sources into the aquatic environment, the results of which are such as to cause hazards to human health, harm to living resources and to aquatic ecosystems, damage to amenities or interference with other legitimate uses of water
vulnerable zone means an area of land designated according to Article 3 (2)
watercraft means any recreational craft or personal watercraft
recreational craft means any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion
personal watercraft means a watercraft intended for sports and leisure purposes of less than 4 m in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull
watercraft built for own use means a watercraft predominantly built by its future user for his own use
propulsion engine means any spark or compression ignition, internal combustion engine used directly or indirectly for propulsion purposes
major engine modification means the modification of a propulsion engine which could potentially cause the engine to exceed the emission limits set out in Part B of Annex I or increases the rated power of the engine by more than 15 %
major craft conversion means a conversion of a watercraft which changes the means of propulsion of the watercraft, involves a major engine modification, or alters the watercraft to such an extent that it may not meet the applicable essential safety and environmental requirements laid down in this Directive
means of propulsion means the method by which the watercraft is propelled
engine family means the manufacturer’s grouping of engines which, through their design, have similar exhaust or noise emission characteristics
hull length means the length of the hull measured in accordance with the harmonised standard
making available on the market means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a product on the Union market
putting into service means the first use of a product covered by this Directive in the Union by its end-user
manufacturer means any natural or legal person who manufactures a product or has such a product designed or manufactured, and markets that product under his name or trademark
authorised representative means any natural or legal person established within the Union who has received a written mandate from the manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places a product from a third country on the Union market
private importer means any natural or legal person established within the Union who imports in the course of a non-commercial activity a product from a third country into the Union with the intention of putting it into service for his own use
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
harmonised standard means harmonised standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012
accreditation means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008
national accreditation body means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008
conformity assessment means the process demonstrating whether the requirements of this Directive relating to a product have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of a product that has already been made available to the end-user
withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market
market surveillance means the activities carried out and measures taken by public authorities to ensure that products comply with the applicable requirements set out in Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection
CE marking means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
internal borders means:
(a) the common land borders, including river and lake borders, of the Member States;
(b) the airports of the Member States for internal flights;
(c) sea, river and lake ports of the Member States for regular internal ferry connections
external borders means the Member States’ land borders, including river and lake borders, sea borders and their airports, river ports, sea ports and lake ports, provided that they are not internal borders
internal flight means any flight exclusively to or from the territories of the Member States and not landing in the territory of a third country
regular internal ferry connection means any ferry connection between the same two or more ports situated on the territory of the Member States, not calling at any ports situated outside the territory of the Member States, and consisting of the transport of passengers and vehicles according to a published timetable
persons enjoying the right of free movement under Union law means:
(a) Union citizens within the meaning of Article 20(1) TFEU, and third-country nationals who are members of the family of a Union citizen exercising his or her right to free movement to whom Directive 2004/38/EC of the European Parliament and of the Council applies;
(b) third-country nationals and their family members, whatever their nationality, who, under agreements between the Union and its Member States, on the one hand, and those third countries, on the other hand, enjoy rights of free movement equivalent to those of Union citizens
third-country national means any person who is not a Union citizen within the meaning of Article 20(1) TFEU and who is not covered by point 5 of this Article
persons for whom an alert has been issued for the purposes of refusing entry means any third-country national for whom an alert has been issued in the Schengen Information System (SIS) in accordance with and for the purposes laid down in Articles 24 and 26 of Regulation (EC) No 1987/2006 of the European Parliament and of the Council
border crossing point means any crossing-point authorised by the competent authorities for the crossing of external borders
shared border crossing point means any border crossing point situated either on the territory of a Member State or on the territory of a third country, at which Member State border guards and third-country border guards carry out exit and entry checks one after another in accordance with their national law and pursuant to a bilateral agreement
border control means the activity carried out at a border, in accordance with and for the purposes of this Regulation, in response exclusively to an intention to cross or the act of crossing that border, regardless of any other consideration, consisting of border checks and border surveillance
border checks means the checks carried out at border crossing points, to ensure that persons, including their means of transport and the objects in their possession, may be authorised to enter the territory of the Member States or authorised to leave it
border surveillance means the surveillance of borders between border crossing points and the surveillance of border crossing points outside the fixed opening hours, in order to prevent persons from circumventing border checks
second line check means a further check which may be carried out in a special location away from the location at which all persons are checked (first line)
border guard means any public official assigned, in accordance with national law, to a border crossing point or along the border or the immediate vicinity of that border who carries out, in accordance with this Regulation and national law, border control tasks
carrier means any natural or legal person whose profession it is to provide transport of persons
residence permit means:
(a) all residence permits issued by the Member States according to the uniform format laid down by Council Regulation (EC) No 1030/2002 and residence cards issued in accordance with Directive 2004/38/EC;
(b) all other documents issued by a Member State to third-country nationals authorising a stay on its territory that have been the subject of a notification and subsequent publication in accordance with Article 39, with the exception of:
(i) temporary permits issued pending examination of a first application for a residence permit as referred to in point (a) or an application for asylum; and
(ii) visas issued by the Member States in the uniform format laid down by Council Regulation (EC) No 1683/95
cruise ship means a ship which follows a given itinerary in accordance with a predetermined programme, which includes a programme of tourist activities in the various ports, and which normally neither takes passengers on nor allows passengers to disembark during the voyage
pleasure boating means the use of pleasure boats for sporting or tourism purposes
coastal fisheries means fishing carried out with the aid of vessels which return every day or within 36 hours to a port situated in the territory of a Member State without calling at a port situated in a third country
offshore worker means a person working on an offshore installation located in the territorial waters or in an area of exclusive maritime economic exploitation of the Member States, as defined under the international law of the sea, and who returns regularly by sea or air to the territory of the Member States
threat to public health means any disease with epidemic potential as defined by the International Health Regulations of the World Health Organization and other infectious diseases or contagious parasitic diseases if they are the subject of protection provisions applying to nationals of the Member States
intellectual property right means:
(a) a trade mark;
(b) a design;
(c) a copyright or any related right as provided for by national or Union law;
(d) a geographical indication;
(e) a patent as provided for by national or Union law;
(f) a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products;
(g) a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products;
(h) a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights;
(i) a plant variety right as provided for by national law;
(j) a topography of semiconductor product as provided for by national or Union law;
(k) a utility model in so far as it is protected as an intellectual property right by national or Union law;
(l) a trade name in so far as it is protected as an exclusive intellectual property right by national or Union law
trade mark means:
(a) a Community trade mark as provided for in Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark;
(b) a trade mark registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property;
(c) a trade mark registered under international arrangements which has effect in a Member State or in the Union
design means:
(a) a Community design as provided for in Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs;
(b) a design registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property;
(c) a design registered under international arrangements which has effect in a Member State or in the Union
geographical indication means:
(a) a geographical indication or designation of origin protected for agricultural products and foodstuff as provided for in Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs;
(b) a designation of origin or geographical indication for wine as provided for in Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation);
(c) a geographical designation for aromatised drinks based on wine products as provided for in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails;
(d) a geographical indication of spirit drinks as provided for in Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks;
(e) a geographical indication for products not falling under points (a) to (d) in so far as it is established as an exclusive intellectual property right by national or Union law;
(f) a geographical indication as provided for in Agreements between the Union and third countries and as such listed in those Agreements
counterfeit goods means:
(a) goods which are the subject of an act infringing a trade mark in the Member State where they are found and bear without authorisation a sign which is identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark;
(b) goods which are the subject of an act infringing a geographical indication in the Member State where they are found and, bear or are described by, a name or term protected in respect of that geographical indication;
(c) any packaging, label, sticker, brochure, operating instructions, warranty document or other similar item, even if presented separately, which is the subject of an act infringing a trade mark or a geographical indication, which includes a sign, name or term which is identical to a validly registered trade mark or protected geographical indication, or which cannot be distinguished in its essential aspects from such a trade mark or geographical indication, and which can be used for the same type of goods as that for which the trade mark or geographical indication has been registered
pirated goods means goods which are the subject of an act infringing a copyright or related right or a design in the Member State where the goods are found and which are, or contain copies, made without the consent of the holder of a copyright or related right or a design, or of a person authorised by that holder in the country of production
goods suspected of infringing an intellectual property right means goods with regard to which there are reasonable indications that, in the Member State where those goods are found, they are prima facie:
(a) goods which are the subject of an act infringing an intellectual property right in that Member State;
(b) devices, products or components which are primarily designed, produced or adapted for the purpose of enabling or facilitating the circumvention of any technology, device or component that, in the normal course of its operation, prevents or restricts acts in respect of works which are not authorised by the holder of any copyright or any right related to copyright and which relate to an act infringing those rights in that Member State;
(c) any mould or matrix which is specifically designed or adapted for the manufacture of goods infringing an intellectual property right, if such moulds or matrices relate to an act infringing an intellectual property right in that Member State
right-holder means the holder of an intellectual property right
application means a request made to the competent customs department for customs authorities to take action with respect to goods suspected of infringing an intellectual property right
national application means an application requesting the customs authorities of a Member State to take action in that Member State
Union application means an application submitted in one Member State and requesting the customs authorities of that Member State and of one or more other Member States to take action in their respective Member States
applicant means the person or entity in whose name an application is submitted
holder of the decision means the holder of a decision granting an application
holder of the goods means the person who is the owner of the goods suspected of infringing an intellectual property right or who has a similar right of disposal, or physical control, over such goods
declarant means the declarant as defined in point (18) of Article 4 of Regulation (EEC) No 2913/92
destruction means the physical destruction, recycling or disposal of goods outside commercial channels, in such a way as to preclude damage to the holder of the decision
customs territory of the Union means the customs territory of the Community as defined in Article 3 of Regulation (EEC) No 2913/92
release of the goods means the release of the goods as defined in point (20) of Article 4 of Regulation (EEC) No 2913/92
small consignment means a postal or express courier consignment, which:
(a) contains three units or less; or
(b) has a gross weight of less than two kilograms.
For the purpose of point (a), ‘units’ means goods as classified under the Combined Nomenclature in accordance with Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff if unpackaged, or the package of such goods intended for retail sale to the ultimate consumer.
For the purpose of this definition, separate goods falling in the same Combined Nomenclature code shall be considered as different units and goods presented as sets classified in one Combined Nomenclature code shall be considered as one unit
perishable goods means goods considered by customs authorities to deteriorate by being kept for up to 20 days from the date of their suspension of release or detention
exclusive licence means a licence (whether general or limited) authorising the licensee to the exclusion of all other persons, including the person granting the licence, to use an intellectual property right in the manner authorised by the licence
energy-related product or product means a good or system with an impact on energy consumption during use which is placed on the market or put into service, including parts with an impact on energy consumption during use which are placed on the market or put into service for customers and that are intended to be incorporated into products
product group means a group of products which have the same main functionality
system means a combination of several goods which when put together perform a specific function in an expected environment and of which the energy efficiency can then be determined as a single entity
model means a version of a product of which all units share the same technical characteristics relevant for the label and the product information sheet and the same model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same supplier's name
equivalent model means a model which has the same technical characteristics relevant for the label and the same product information sheet, but which is placed on the market or put into service by the same supplier as another model with a different model identifier
making available on the market means the supply of a product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a product on the Union market
putting into service means the first use of a product for its intended purpose on the Union market
manufacturer means a natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark
authorised representative means a natural or legal person established in the Union who has received a written mandate from the manufacturer to act on its behalf in relation to specified tasks
importer means a natural or legal person established in the Union who places a product from a third country on the Union market
dealer means a retailer or other natural or legal person who offers for sale, hire, or hire purchase, or displays products to customers or installers in the course of a commercial activity, whether or not in return for payment
supplier means a manufacturer established in the Union, the authorised representative of a manufacturer who is not established in the Union, or an importer, who places a product on the Union market
distance selling means the offer for sale, hire or hire purchase by mail order, catalogue, internet, telemarketing or by any other method by which the potential customer cannot be expected to see the product displayed
customer means a natural or legal person who buys, hires or receives a product for own use whether or not acting for purposes which are outside its trade, business, craft or profession
energy efficiency means the ratio of output of performance, service, goods or energy to input of energy
harmonised standard means standard as defined in point (c) of Article 2(1) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council
label means a graphic diagram, either in printed or electronic form, including a closed scale using only letters from A to G, each letter representing a class and each class corresponding to energy savings, in seven different colours from dark green to red, in order to inform customers about energy efficiency and energy consumption; it includes rescaled labels and labels with fewer classes and colours in accordance with Article 11(10) and (11)
rescaling means an exercise making the requirements for achieving the energy class on a label for a particular product group more stringent
rescaled label means a label for a particular product group that has undergone rescaling and is distinguishable from labels before rescaling while preserving a visual and perceptible coherence of all labels
product information sheet means a standard document containing information relating to a product, in printed or electronic form
technical documentation means documentation sufficient to enable market surveillance authorities to assess the accuracy of the label and the product information sheet of a product, including test reports or similar technical evidence
supplementary information means information, as specified in a delegated act, on the functional and environmental performance of a product
product database means a collection of data concerning products, which is arranged in a systematic manner and consists of a consumer-oriented public part, where information concerning individual product parameters is accessible by electronic means, an online portal for accessibility and a compliance part, with clearly specified accessibility and security requirements
verification tolerance means the maximum admissible deviation of the measurement and calculation results of the verification tests performed by, or on behalf of, market surveillance authorities, compared to the values of the declared or published parameters, reflecting deviation arising from interlaboratory variation
Energy-related product (a ‘product’) means any good that has an impact on energy consumption during use which is placed on the market and/or put into service, and includes parts intended to be incorporated into energy-related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently
Components and sub-assemblies means parts intended to be incorporated into products which are not placed on the market and/or put into service as individual parts for end-users or the environmental performance of which cannot be assessed independently
Implementing measures means measures adopted pursuant to this Directive laying down ecodesign requirements for defined products or for environmental aspects thereof
Placing on the market means making a product available for the first time on the Community market with a view to its distribution or use within the Community, whether for reward or free of charge and irrespective of the selling technique
Putting into service means the first use of a product for its intended purpose by an end-user in the Community
Manufacturer means the natural or legal person who manufactures products covered by this Directive and is responsible for their conformity with this Directive in view of their being placed on the market and/or put into service under the manufacturer’s own name or trademark or for the manufacturer’s own use. In the absence of a manufacturer as defined in the first sentence of this point or of an importer as defined in point 8, any natural or legal person who places on the market and/or puts into service products covered by this Directive shall be considered a manufacturer
Authorised representative means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive
Importer means any natural or legal person established in the Community who places a product from a third country on the Community market in the course of his business
Materials means all materials used during the life cycle of a product
Product design means the set of processes that transform legal, technical, safety, functional, market or other requirements to be met by a product into the technical specification for that product
Environmental aspect means an element or function of a product that can interact with the environment during its life cycle
Environmental impact means any change to the environment wholly or partially resulting from a product during its life cycle
Life cycle means the consecutive and interlinked stages of a product from raw material use to final disposal
Reuse means any operation by which a product or its components, having reached the end of their first use, are used for the same purpose for which they were conceived, including the continued use of a product which is returned to a collection point, distributor, recycler or manufacturer, as well as reuse of a product following refurbishment
Recycling means the reprocessing in a production process of waste materials for the original purpose or for other purposes but excluding energy recovery
Energy recovery means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat
Recovery means any of the applicable operations provided for in Annex II B to Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste
Waste means any substance or object in the categories set out in Annex I to Directive 2006/12/EC which the holder discards or intends, or is required, to discard
Hazardous waste means any waste which is covered by Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste
Ecological profile means a description, in accordance with the implementing measure applicable to the product, of the inputs and outputs (such as materials, emissions and waste) associated with a product throughout its life cycle which are significant from the point of view of its environmental impact and are expressed in physical quantities that can be measured
Environmental performance of a product means the results of the manufacturer’s management of the environmental aspects of the product, as reflected in its technical documentation file
Improvement of the environmental performance means the process of enhancing the environmental performance of a product over successive generations, although not necessarily in respect of all environmental aspects of the product simultaneously
Ecodesign means the integration of environmental aspects into product design with the aim of improving the environmental performance of the product throughout its whole life cycle
Ecodesign requirement means any requirement in relation to a product, or the design of a product, intended to improve its environmental performance, or any requirement for the supply of information with regard to the environmental aspects of a product
Generic ecodesign requirement means any ecodesign requirement based on the ecological profile as a whole of a product without set limit values for particular environmental aspects
Specific ecodesign requirement means a quantified and measurable ecodesign requirement relating to a particular environmental aspect of a product, such as energy consumption during use, calculated for a given unit of output performance
Harmonised standard means a technical specification adopted by a recognised standards body under a mandate from the Commission, in accordance with the procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, for the purpose of establishing a European requirement, compliance with which is not compulsory
Member State of origin means the Member State where the organ is procured with the purpose of transplantation
Meat means edible parts of the animals referred to in points 1.2 to 1.8, including blood
Domestic ungulates means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds
Poultry means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites
Lagomorphs means rabbits, hares and rodents
Wild game means:
— wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and
— wild birds that are hunted for human consumption
Fanned game means farmed ratites and farmed land mammals other than those referred to in point 1.2
Small wild game means wild game birds and lagomorphs living freely in the wild
Large wild game means wild land mammals living freely in the wild that do not fall within the definition of small wild game
Carcase means the body of an animal after slaughter and dressing
Fresh meat means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere
Offal means fresh meat other than that of the carcase, including viscera and blood
Viscera means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop
Minced meat means boned meat that has been minced into fragments and contains less than 1% salt
Mechanically separated meat or MSM means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure
Meat preparations means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat
Slaughterhouse means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption
Cutting plant means an establishment used for boning and/or cutting up meat
Game-handling establishment means any establishment in which game and game meat obtained after hunting are prepared for placing on the market
Bivalve molluscs means filter-feeding lamellibranch molluscs
Marine biotoxins means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins
Conditioning means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging
Gatherer means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market
Production area means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken
Relaying area means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs
Dispatch centre means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption
Purification centre means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption
Relaying means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening
Fishery products means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals
Factory vessel means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing
Freezer vessel means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging
Mechanically separated fishery product means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure
Fresh fishery products means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling
Prepared fishery products means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping
Raw milk means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40oC or undergone any treatment that has an equivalent effect
Milk production holding means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food
Eggs means eggs in shell - other than broken, incubated or cooked eggs - that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products
Liquid egg means unprocessed egg contents after removal of the shell
Cracked eggs means eggs with damaged shell and intact membranes
Packing centre means an establishment where eggs are graded by quality and weight
Frogs’ legs means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae)
Snails means terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and species of the family Achatinidae
Meat products means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat
Dairy products means processed products resulting from the processing of raw milk or from the further processing of such processed products
Egg products means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products
Processed fishery products means processed products resulting from the processing of fishery products or from the further processing of such processed products
Rendered animal fat means fat derived from rendering meat, including bones, and intended for human consumptio
Greaves means the protein-containing residue of rendering, after partial separation of fat and water
Gelatine means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals
Collagen means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation
Treated stomachs, bladders and intestines means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning
Products of animal origin means:
— food of animal origin, including honey and blood;
— live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and
— other animals destined to be prepared with a view to being supplied live to the final consumer
Wholesale market means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators
firearm means any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded from that definition for one of the reasons listed in Part III of Annex I. Firearms are classified in Part II of Annex I.
An object shall be considered to be capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:
(a) it has the appearance of a firearm; and
(b) as a result of its construction or the material from which it is made, it can be so converted
essential component means the barrel, the frame, the receiver, including both upper and lower receivers, where applicable, the slide, the cylinder, the bolt or the breech block, which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted
ammunition means the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the Member State concerned
alarm and signal weapons means devices with a cartridge holder which are designed to fire only blanks, irritants, other active substances or pyrotechnic signalling rounds and which are not capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant
salute and acoustic weapons means firearms specifically converted for the sole use of firing blanks, for use such as in theatre performances, photographic sessions, film and television recordings, historical re-enactments, parades, sporting events and training
deactivated firearms means firearms that have been rendered permanently unfit for use by deactivation, ensuring that all essential components of the firearm in question have been rendered permanently inoperable and incapable of removal, replacement or modification in a manner that would permit the firearm to be reactivated in any way
museum means a permanent institution in the service of society and its development, open to the public, which acquires, conserves, researches and exhibits firearms, essential components or ammunition for historical, cultural, scientific, technical, educational, heritage or recreational purposes, and recognised as such by the Member State concerned
collector means any natural or legal person dedicated to the gathering and conservation of firearms, essential components or ammunition for historical, cultural, scientific, technical, educational or heritage purposes, and recognised as such by the Member State concerned
dealer means any natural or legal person whose trade or business consists wholly or partly of either of the following:
(a) the manufacture, trade, exchange, hiring out, repair, modification or conversion of firearms or essential components;
(b) the manufacture, trade, exchange, modification or conversion of ammunition;
broker means any natural or legal person, other than a dealer, whose trade or business consists wholly or partly of either of the following:
(a) the negotiation or arrangement of transactions for the purchase, sale or supply of firearms, essential components or ammunition;
(b) arranging the transfer of firearms, essential components or ammunition within a Member State, from one Member State to another Member State, from a Member State to a third country or from a third country to a Member State
illicit manufacturing means the manufacturing or assembly of firearms, their essential components and ammunition:
(a) from any essential component of such firearms illicitly trafficked;
(b) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(c) without marking firearms at the time of manufacture in accordance with Article 4
illicit trafficking means the acquisition, sale, delivery, movement or transfer of firearms, their essential components or ammunition from or through the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with this Directive or if the firearms, essential components or ammunition are not marked in accordance with Article 4
tracing means the systematic tracking of firearms and, where possible, their essential components and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking
short firearm means a firearm with a barrel not exceeding 30 centimetres or whose overall length does not exceed 60 centimetres
long firearm means any firearm other than a short firearm
automatic firearm means a firearm which reloads automatically each time a round is fired and can fire more than one round with one pull on the trigger
semi-automatic firearm means a firearm which reloads automatically each time a round is fired and can fire only one round with one pull on the trigger
repeating firearm means a firearm which after a round has been fired is designed to be reloaded from a magazine or cylinder by means of a manually-operated action
single-shot firearm means a firearm with no magazine which is loaded before each shot by the manual insertion of a round into the chamber or a loading recess at the breech of the barrel
ammunition with penetrating projectiles means ammunition for military use where the projectile is jacketed and has a penetrating hard core
ammunition with explosive projectiles means ammunition for military use where the projectile contains a charge which explodes on impact
ammunition with incendiary projectiles means ammunition for military use where the projectile contains a chemical mixture which bursts into flame on contact with the air or on impact
medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point
accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)
custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices
active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device
implantable device means any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device
invasive device means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body
generic device group means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics
single-use device means a device that is intended to be used on one individual during a single procedure
falsified device means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights
procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose
system means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose
intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation
label means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices
instructions for use means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken
Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market
non-viable means having no potential for metabolism or multiplication
derivative means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues
nanomaterial means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials
particle for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries
agglomerate for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components
aggregate for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles
performance means the ability of a device to achieve its intended purpose as stated by the manufacturer
risk means the combination of the probability of occurrence of harm and the severity of that harm
benefit-risk determination means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer
compatibility is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
(a) perform without losing or compromising the ability to perform as intended, and/or
(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse reaction
interoperability is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
(a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
(b) communicate with each other, and/or
(c) work together as intended
making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a device, other than an investigational device, on the Union market
putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose
manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark
fully refurbishing for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device
authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation
importer means any natural or legal person established within the Union that places a device from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service
economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3)
health institution means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health
user means any healthcare professional or lay person who uses a device
lay person means an individual who does not have formal education in a relevant field of healthcare or medical discipline
reprocessing means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device
conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled
conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection
notified body means a conformity assessment body designated in accordance with this Regulation
CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing
clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer
clinical investigation means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device
investigational device means a device that is assessed in a clinical investigation
clinical investigation plan means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation
clinical data means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
— clinical investigation(s) of the device concerned,
— clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
— reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up
sponsor means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation
subject means an individual who participates in a clinical investigation
clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer
clinical performance means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer
clinical benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health
investigator means an individual responsible for the conduct of a clinical investigation at a clinical investigation site
informed consent means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation
ethics committee means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations
adverse event means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device
serious adverse event means any adverse event that led to any of the following:
(a) death,
(b) serious deterioration in the health of the subject, that resulted in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect
serious adverse event means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer
post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions
market surveillance means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection
recall means any measure aimed at achieving the return of a device that has already been made available to the end user
withdrawal means any measure aimed at preventing a device in the supply chain from being further made available on the market
incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect
serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
(c) a serious public health threat
serious public health threat means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation
field safety corrective action means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market
field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action
common specifications (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system
Transient means normally intended for continuous use for less than 60 minutes
Short term means normally intended for continuous use for between 60 minutes and 30 days
Long term means normally intended for continuous use for more than 30 days
Body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma
Surgically invasive device means:
(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
(b) a device which produces penetration other than through a body orifice
Reusable surgical instrument means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out
Active therapeutic device means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability
Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities
Central circulatory system means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior
Central nervous system means the brain, meninges and spinal cord
Injured skin or mucous membrane means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound
reproductive cells means all tissues and cells intended to be used for the purpose of assisted reproduction
partner donation means the donation of reproductive cells between a man and a woman who declare that they have an intimate physical relationship
quality system means the organisational structure, defined responsibilities, procedures, processes, and resources for implementing quality management and includes all activities which contribute to quality, directly or indirectly
quality management means the coordinated activities to direct and control an organisation with regard to quality
Standard Operating Procedures (SOPs) means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product
validation (or ‘qualification’ in the case of equipment or environments) means establishing documented evidence that provides a high degree of assurance that a specific process, piece of equipment or environment will consistently produce a product meeting its predetermined specifications and quality attributes; a process is validated to evaluate the performance of a system with regard to its effectiveness based on intended use
traceability means the ability to locate and identify the tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal, which also implies the ability to identify the donor and the tissue establishment or the manufacturing facility receiving, processing or storing the tissue/cells, and the ability to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s); traceability also covers the ability to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells
critical means potentially having an effect on the quality and/or safety of or having contact with the cells and tissues
procurement organisation means a health care establishment or a unit of a hospital or another body that undertakes the procurement of human tissues and cells and that may not be accredited, designated, authorised or licensed as a tissue establishment
organisations responsible for human application means a health care establishment or a unit of a hospital or another body which carries out human application of human tissues and cells
Single European Code or SEC means the unique identifier applied to tissues and cells distributed in the Union. The Single European Code consists of a donation identification sequence and a product identification sequence, as further specified in Annex VII to this Directive
donation identification sequence means the first part of the Single European Code consisting of the EU tissue establishment code and the unique donation number
EU tissue establishment code means the unique identifier for accredited, designated, authorised, or licensed tissue establishments in the Union. The tissue establishment code consists of an ISO country code and the tissue establishment number set out in the EU Tissue Establishment Compendium, as further specified in Annex VII to this Directive
unique donation number means the unique number attributed to a specific donation of tissues and cells in line with the system in place in each Member State for allocating such numbers, as further specified in Annex VII to this Directive
product identification sequence means the second part of the Single European Code consisting of the product code, the split number and the expiry date
product code means the identifier for the specific type of tissue and cell in question. The product code consists of the product coding system identifier indicating the coding system used by the tissue establishment (‘E’ for the EUTC, ‘A’ for ISBT128, ‘B’ for Eurocode) and the tissues and cells product number foreseen in the respective coding system for the product type, as further defined in Annex VII to this Directive
split number means the number which distinguishes and uniquely identifies tissues and cells having the same unique donation number and the same product code and originating from the same tissue establishment, as further defined in Annex VII to this Directive
expiry date means the date by which the tissues and cells can be applied, as further defined in Annex VII to this Directive
EU Coding Platform means the IT platform hosted by the Commission which contains the EU Tissue Establishment Compendium and the EU Tissue and Cell Product Compendium
EU Tissue Establishment Compendium means the register of all tissue establishments which are authorised, licensed, designated or accredited by the Member States' competent authority or authorities and which contains the information about these tissue establishments as set out in Annex VIII to this Directive
EU Tissue and Cell Product Compendium means the register of all types of tissues and cells circulating in the Union and the respective product codes under the three permitted coding systems (EUTC, ISBT128 and Eurocode)
EUTC means the product coding system for tissues and cells developed by the Union consisting of a register of all types of tissues and cells circulating in the Union and their corresponding product codes
released for circulation means distribution for human application or transfer to another operator, e.g. for further processing with or without return
within the same centre means that all steps from procurement to human application are carried out under the same responsible person, quality management system and traceability system, within a healthcare centre comprising at least an accredited, designated, authorised, or licensed tissue establishment and an organisation responsible for human application at the same location
pooling means the physical contact or mixing in a single container, of tissues or cells from more than one procurement from the same donor, or from two or more donors
Member State of origin means the Member State where the organ is procured with the purpose of transplantation
Member State of destination means the Member State to which the organ is sent for the purpose of transplantation
National donor/recipient identification number means the identification code attributed to a donor or a recipient in accordance with the identification system established at national level pursuant to Article 10(2) of Directive 2010/53/EU
Specification of the organ means (1) the anatomical description of an organ including: its type (e.g. heart, liver); (2) where applicable, its position (left or right) in the body; and (3) whether it is a whole organ or a part of an organ, mentioning the lobe or segment of the organ
a delegated body means a body to which tasks have been delegated in accordance with Article 17(1) of Directive 2010/53/EU or a European organ exchange organisation to which tasks have been delegated in accordance with Article 21 of Directive 2010/53/EU
demand facility means a facility which consumes electrical energy and is connected at one or more connection points to the transmission or distribution system. A distribution system and/or auxiliary supplies of a power generating module do no constitute a demand facility
transmission-connected demand facility means a demand facility which has a connection point to a transmission system
transmission-connected distribution facility means a distribution system connection or the electrical plant and equipment used at the connection to the transmission system
demand unit means an indivisible set of installations containing equipment which can be actively controlled by a demand facility owner or by a CDSO, either individually or commonly as part of demand aggregation through a third party
closed distribution system means a distribution system classified pursuant to Article 28 of Directive 2009/72/EC as a closed distribution system by national regulatory authorities or by other competent authorities, where so provided by the Member State, which distributes electricity within a geographically confined industrial, commercial or shared services site and does not supply household customers, without prejudice to incidental use by a small number of households located within the area served by the system and with employment or similar associations with the owner of the system
main demand equipment means at least one of the following equipment: motors, transformers, high voltage equipment at the connection point and at the process production plant
transmission-connected distribution system means a distribution system connected to a transmission system, including transmission-connected distribution facilities
maximum export capability means the maximum continuous active power that a transmission-connected demand facility or a transmission-connected distribution facility, can feed into the network at the connection point, as specified in the connection agreement or as agreed between the relevant system operator and the transmission-connected demand facility owner or transmission-connected distribution system operator respectively
maximum export capability means the maximum continuous active power that a transmission-connected demand facility or a transmission-connected distribution facility, can feed into the network at the connection point, as specified in the connection agreement or as agreed between the relevant system operator and the transmission-connected demand facility owner or transmission-connected distribution system operator respectively
low voltage demand disconnection means a restoration action where demand is disconnected during a low voltage event in order to recover voltage to acceptable limits
low frequency demand disconnection means an action where demand is disconnected during a low frequency event in order to recover the balance between demand and generation and restore system frequency to acceptable limits
low voltage demand disconnection means a restoration action where demand is disconnected during a low voltage event in order to recover voltage to acceptable limits
on load tap changer blocking means an action that blocks the on load tap changer during a low voltage event in order to stop transformers from further tapping and suppressing voltages in an area
control room means a relevant system operator's operation centre
block loading means the maximum step active power loading of reconnected demand during system restoration after black-out
demand response active power control means demand within a demand facility or closed distribution system that is available for modulation by the relevant system operator or relevant TSO, which results in an active power modification
demand response reactive power control means reactive power or reactive power compensation devices in a demand facility or closed distribution system that are available for modulation by the relevant system operator or relevant TSO
demand response transmission constraint management means demand within a demand facility or closed distribution system that is available for modulation by the relevant system operator or relevant TSO to manage transmission constraints within the system
demand aggregation means a set of demand facilities or closed distribution systems which can operate as a single facility or closed distribution system for the purposes of offering one or more demand response services
demand response system frequency control means demand within a demand facility or closed distribution system that is available for reduction or increase in response to frequency fluctuations, made by an autonomous response from the demand facility or closed distribution system to diminish these fluctuations
demand response very fast active power control means demand within a demand facility or closed distribution system that can be modulated very fast in response to a frequency deviation, which results in a very fast active power modification
demand response unit document’ (DRUD) means a document, issued either by the demand facility owner or the CDSO to the relevant system operator for demand units with demand response and connected at a voltage level above 1 000 V, which confirms the compliance of the demand unit with the technical requirements set out in this Regulation and provides the necessary data and statements, including a statement of compliance
entity means a regulatory authority, other national authority, system operator or other public or private body appointed under national law
synchronous area means an area covered by synchronously interconnected TSOs, such as the synchronous areas of Continental Europe, Great Britain, Ireland-Northern Ireland and Nordic and the power systems of Lithuania, Latvia and Estonia, together referred to as ‘Baltic’ which are part of a wider synchronous area
voltage means the difference in electrical potential between two points measured as the root-mean-square value of the positive sequence phase-to-phase voltages at fundamental frequency
apparent power means the product of voltage and current at fundamental frequency, and the square root of three in the case of three-phase systems, usually expressed in kilovolt-amperes (‘kVA’) or megavolt-amperes (‘MVA’)
power-generating module means either a synchronous power-generating module or a power park module
power-generating facility means a facility that converts primary energy into electrical energy and which consists of one or more power-generating modules connected to a network at one or more connection points
power-generating facility owner means a natural or legal entity owning a power-generating facility
main generating plant means one or more of the principal items of equipment required to convert the primary source of energy into electricity
synchronous power-generating module means an indivisible set of installations which can generate electrical energy such that the frequency of the generated voltage, the generator speed and the frequency of network voltage are in a constant ratio and thus in synchronism
power-generating module document or PGMD means a document provided by the power-generating facility owner to the relevant system operator for a type B or C power-generating module which confirms that the power-generating module's compliance with the technical criteria set out in this Regulation has been demonstrated and provides the necessary data and statements, including a statement of compliance
relevant TSO means the TSO in whose control area a power-generating module, a demand facility, a distribution system or a HVDC system is or will be connected to the network at any voltage level
network means a plant and apparatus connected together in order to transmit or distribute electricity
relevant system operator means the transmission system operator or distribution system operator to whose system a power-generating module, demand facility, distribution system or HVDC system is or will be connected
connection agreemen means a contract between the relevant system operator and either the power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner, which includes the relevant site and specific technical requirements for the power-generating facility, demand facility, distribution system, distribution system connection or HVDC system
connection point means the interface at which the power-generating module, demand facility, distribution system or HVDC system is connected to a transmission system, offshore network, distribution system, including closed distribution systems, or HVDC system, as identified in the connection agreement
maximum capacity or Pmax means the maximum continuous active power which a power-generating module can produce, less any demand associated solely with facilitating the operation of that power-generating module and not fed into the network as specified in the connection agreement or as agreed between the relevant system operator and the power-generating facility owner
power park module or PPM means a unit or ensemble of units generating electricity, which is either non-synchronously connected to the network or connected through power electronics, and that also has a single connection point to a transmission system, distribution system including closed distribution system or HVDC system
offshore power park module means a power park module located offshore with an offshore connection point
synchronous compensation operation means the operation of an alternator without prime mover to regulate voltage dynamically by production or absorption of reactive power
active power means the real component of the apparent power at fundamental frequency, expressed in watts or multiples thereof such as kilowatts (‘kW’) or megawatts (‘MW’)
pump-storag means a hydro unit in which water can be raised by means of pumps and stored to be used for the generation of electrical energy
frequency means the electric frequency of the system expressed in hertz that can be measured in all parts of the synchronous area under the assumption of a consistent value for the system in the time frame of seconds, with only minor differences between different measurement locations. Its nominal value is 50Hz
droop means the ratio of a steady-state change of frequency to the resulting steady-state change in active power output, expressed in percentage terms. The change in frequency is expressed as a ratio to nominal frequency and the change in active power expressed as a ratio to maximum capacity or actual active power at the moment the relevant threshold is reached
minimum regulating level means the minimum active power, as specified in the connection agreement or as agreed between the relevant system operator and the power-generating facility owner, down to which the power-generating module can control active power
setpoint means the target value for any parameter typically used in control schemes
instruction means any command, within its authority, given by a system operator to a power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner in order to perform an action
secured fault means a fault which is successfully cleared according to the system operator's planning criteria
reactive power means the imaginary component of the apparent power at fundamental frequency, usually expressed in kilovar (‘kVAr’) or megavar (‘MVAr’)
fault-ride-through means the capability of electrical devices to be able to remain connected to the network and operate through periods of low voltage at the connection point caused by secured faults
alternator means a device that converts mechanical energy into electrical energy by means of a rotating magnetic field
current means the rate at which electric charge flows which is measured by the root-mean-square value of the positive sequence of the phase current at fundamental frequency
stator means the portion of a rotating machine which includes the stationary magnetic parts with their associated windings
inertia means the property of a rotating rigid body, such as the rotor of an alternator, such that it maintains its state of uniform rotational motion and angular momentum unless an external torque is applied
synthetic inertia means the facility provided by a power park module or HVDC system to replace the effect of inertia of a synchronous power-generating module to a prescribed level of performance
frequency control means the capability of a power-generating module or HVDC system to adjust its active power output in response to a measured deviation of system frequency from a setpoint, in order to maintain stable system frequency
frequency sensitive mode or FSM means the operating mode of a power-generating module or HVDC system in which the active power output changes in response to a change in system frequency, in such a way that it assists with the recovery to target frequency
limited frequency sensitive mode — overfrequency or LFSM-O means a power-generating module or HVDC system operating mode which will result in active power output reduction in response to a change in system frequency above a certain value
limited frequency sensitive mode — underfrequency, LFSM-U means a power-generating module or HVDC system operating mode which will result in active power output increase in response to a change in system frequency below a certain value
frequency response deadband means an interval used intentionally to make the frequency control unresponsive
frequency response insensitivity means the inherent feature of the control system specified as the minimum magnitude of change in the frequency or input signal that results in a change of output power or output signal
P-Q-capability diagram means a diagram describing the reactive power capability of a power-generating module in the context of varying active power at the connection point
steady-state stability means the ability of a network or a synchronous power-generating module to revert and maintain stable operation following a minor disturbance
island operation means the independent operation of a whole network or part of a network that is isolated after being disconnected from the interconnected system, having at least one power-generating module or HVDC system supplying power to this network and controlling the frequency and voltage
houseload operation means the operation which ensures that power-generating facilities are able to continue to supply their in-house loads in the event of network failures resulting in power-generating modules being disconnected from the network and tripped onto their auxiliary supplies
black start capability means the capability of recovery of a power-generating module from a total shutdown through a dedicated auxiliary power source without any electrical energy supply external to the power-generating facility
authorised certifier means an entity that issues equipment certificates and power-generating module documents and whose accreditation is given by the national affiliate of the European cooperation for Accreditation (‘EA’), established in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council
equipment certificate means a document issued by an authorised certifier for equipment used by a power-generating module, demand unit, distribution system, demand facility or HVDC system. The equipment certificate defines the scope of its validity at a national or other level at which a specific value is selected from the range allowed at a European level. For the purpose of replacing specific parts of the compliance process, the equipment certificate may include models that have been verified against actual test results
excitation control system means a feedback control system that includes the synchronous machine and its excitation system
U-Q/Pmax-profile means a profile representing the reactive power capability of a power-generating module or HVDC converter station in the context of varying voltage at the connection point
minimum stable operating level means the minimum active power, as specified in the connection agreement or as agreed between the relevant system operator and the power-generating facility owner, at which the power-generating module can be operated stably for an unlimited time
overexcitation limiter means a control device within the AVR which prevents the rotor of an alternator from overloading by limiting the excitation current
underexcitation limiter means a control device within the AVR, the purpose of which is to prevent the alternator from losing synchronism due to lack of excitation
automatic voltage regulator or AVR means the continuously acting automatic equipment controlling the terminal voltage of a synchronous power-generating module by comparing the actual terminal voltage with a reference value and controlling the output of an excitation control system
power system stabiliser or PSS means an additional functionality of the AVR of a synchronous power-generating module whose purpose is to damp power oscillations
fast fault current means a current injected by a power park module or HVDC system during and after a voltage deviation caused by an electrical fault with the aim of identifying a fault by network protection systems at the initial stage of the fault, supporting system voltage retention at a later stage of the fault and system voltage restoration after fault clearance
power factor means the ratio of the absolute value of active power to apparent power
slope means the ratio of the change in voltage, based on reference 1 pu voltage, to a change in reactive power in-feed from zero to maximum reactive power, based on maximum reactive power
offshore grid connection system means the complete interconnection between an offshore connection point and the onshore system at the onshore grid interconnection point
onshore grid interconnection point means the point at which the offshore grid connection system is connected to the onshore network of the relevant system operator
installation document means a simple structured document containing information about a type A power-generating module or a demand unit, with demand response connected below 1 000 V, and confirming its compliance with the relevant requirements
statement of compliance means a document provided by the power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner to the system operator stating the current status of compliance with the relevant specifications and requirements
final operational notification or FON means a notification issued by the relevant system operator to a power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner who complies with the relevant specifications and requirements, allowing them to operate respectively a power-generating module, demand facility, distribution system or HVDC system by using the grid connection
energisation operational notification or EON means a notification issued by the relevant system operator to a power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner prior to energisation of its internal network
energisation operational notification or EON means a notification issued by the relevant system operator to a power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner prior to energisation of its internal network
limited operational notification or LON means a notification issued by the relevant system operator to a power-generating facility owner, demand facility owner, distribution system operator or HVDC system owner who had previously attained FON status but is temporarily subject to either a significant modification or loss of capability resulting in non-compliance with the relevant specifications and requirements
ADR shall mean the European Agreement concerning the International Carriage of Dangerous Goods by Road, concluded at Geneva on 30 September 1957, as amended
RID shall mean the Regulations concerning the International Carriage of Dangerous Goods by Rail, appearing as Appendix C to the Convention concerning International Carriage by Rail (COTIF) concluded at Vilnius on 3 June 1999, as amended
ADN shall mean the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways, concluded at Geneva on 26 May 2000, as amended
vehicle shall mean any motor vehicle intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h, and any trailer, with the exception of vehicles which run on rails, mobile machinery and agricultural and forestry tractors that do not travel at a speed exceeding 40 km/h when transporting dangerous goods
wagon shall mean any rail vehicle without its own means of propulsion that runs on its own wheels on railway tracks and is used for the carriage of goods
vessel shall mean any inland waterway or seagoing vessel
proceeds means any economic advantage from criminal offences. It may consist of any form of property as defined in the following indent
property includes property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents or instruments evidencing title to or interest in such property
instrumentalities means any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences
confiscation means a penalty or measure, ordered by a court following proceedings in relation to a criminal offence or criminal offences, resulting in the final deprivation of property
legal person means any entity having such status under the applicable national law, except for States or other public bodies in the exercise of State authority and for public international organisations
administrator shall mean any person or body appointed by the administrative or judicial authorities whose task is to administer reorganisation measures
administrative or judicial authorities shall mean such administrative or judicial authorities of the Member States as are competent for the purposes of reorganisation measures or winding-up proceedings
reorganisation measures shall mean measures which are intended to preserve or restore the financial situation of a credit institution or an investment firm as defined in Article 4(1), point (2) of Regulation (EU) No 575/2013 and which could affect third parties’ pre-existing rights, including measures involving the possibility of a suspension of payments, suspension of enforcement measures or reduction of claims; those measures include the application of the resolution tools and the exercise of resolution powers provided for in Directive 2014/59/EU
liquidator shall mean any person or body appointed by the administrative or judicial authorities whose task is to administer winding-up proceedings
winding-up proceedings shall mean collective proceedings opened and monitored by the administrative or judicial authorities of a Member State with the aim of realising assets under the supervision of those authorities, including where the proceedings are terminated by a composition or other, similar measure
operator means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control
genetically modified organism’ or ‘GMO means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC
genetically modified food means food containing, consisting of or produced from GMOs
genetically modified feed means feed containing, consisting of or produced from GMOs
genetically modified organism for food use means a GMO that may be used as food or as a source material for the production of food
genetically modified organism for feed use means a GMO that may be used as feed or as a source material for the production of feed
produced from GMOs means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs
control sample means the GMO or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample)
conventional counterpart means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use
placing on the market means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves
pre-packaged food means any single item for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging
adverse climatic event which can be assimilated to a natural disaster means weather conditions such as frost, hail, ice, rain or drought which destroy more than 30 % of the average annual production of a given farmer in the preceding three-year period or a three-year average based on the preceding five-year period, excluding the highest and lowest entry
green harvesting means the total harvesting on a given area of unripe non-marketable products which have not been damaged prior to the green harvesting, whether due to climatic reasons, disease or otherwise
non-harvesting means the termination of the current production cycle on the area concerned where the product is well developed and is of sound, fair and marketable quality. Destruction of products due to a climatic event or disease is not considered as non-harvesting
green harvesting means the total destruction or removal of grape bunches while still in their immature stage, thereby reducing the yield of the relevant area to zero
a designation of origin means the name of a region, a specific place or, in exceptional and duly justifiable cases, a country used to describe a product referred to in Article 92(1) fulfilling the following requirements:
(i) the quality and characteristics of the product are essentially or exclusively due to a particular geographical environment with its inherent natural and human factors;
(ii) the grapes from which the product is produced come exclusively from that geographical area;
(iii) the production takes place in that geographical area; and
(iv) the product is obtained from vine varieties belonging to Vitis vinifera
a geographical indication means an indication referring to a region, a specific place or, in exceptional and duly justifiable cases, a country, used to describe a product referred to in Article 92(1) fulfilling the following requirements:

(i) it possesses a specific quality, reputation or other characteristics attributable to that geographical origin;

(ii) at least 85 % of the grapes used for its production come exclusively from that geographical area;

(iii) its production takes place in that geographical area; and

(iv) it is obtained from vine varieties belonging to Vitis vinifera or a cross between the Vitis vinifera species and other species of the genus Vitis
name that has become generic means the name of a wine which, although it relates to the place or the region where this product was originally produced or marketed, has become the common name of a wine in the Union
traditional term means a term traditionally used in Member States for the products referred to in Article 92(1) to designate:
(a) that the product has a protected designation of origin or a protected geographical indication under Union or national law; or
(b) the production or ageing method or the quality, colour, type of place, or a particular event linked to the history of the product with a protected designation of origin or a protected geographical indication
labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol placed on any packaging, document, notice, label, ring or collar accompanying or referring to a given product
presentation means any information conveyed to consumers by virtue of the packaging of the product concerned, including the form and type of bottles
collector means an undertaking which transports raw milk from a farmer or another collector to a processor of raw milk or another collector, where the ownership of the raw milk is transferred in each case
first purchaser means an undertaking or group which buys milk from producers in order to:
(a) subject it to collecting, packing, storing, chilling or processing, including under a contract;
(b) sell it to one or more undertakings treating or processing milk or other milk products
economic area means a geographical zone made up of adjoining or neighbouring production regions in which production and marketing conditions are homogeneous
product market means the market comprising all those products which are regarded as interchangeable or substitutable by the consumer by reason of the products' characteristics, their prices and their intended use
geographic market means the market comprising the area in which the undertakings concerned are involved in the supply of the relevant products, in which the conditions of competition are sufficiently homogeneous and which can be distinguished from neighbouring areas, particularly because the conditions of competition are appreciably different in those areas
dominant position means a position of economic strength enjoyed by an undertaking which enables it to prevent effective competition being maintained in the relevant market by giving it the power to behave to an appreciable extent independently of its competitors, customers and ultimately of consumers
Paddy rice means rice which has retained its husk after threshing
Husked rice means paddy rice from which only the husk has been removed. Examples of rice falling within this definition are those with the commercial descriptions 'brown rice', 'cargo rice', 'loonzain' and 'riso sbramato'
Semi-milled rice means paddy rice from which the husk, part of the germ and the whole or part of the outer layers of the pericarp but not the inner layers have been removed
Wholly milled rice means paddy rice from which the husk, the whole of the outer and inner layers of the pericarp, the whole of the germ in the case of long grain or medium grain rice and at least part thereof in the case of round grain rice have been removed, but in which longitudinal white striations may remain on not more than 10 % of the grains
Round grain rice means rice, the grains of which are of a length not exceeding 5,2 mm and of a length/width ratio of less than 2
Medium grain rice means rice, the grains of which are of a length exceeding 5,2 mm but not exceeding 6,0 mm and of a length/width ratio no greater than 3
Long grain rice means
(i) long grain rice A, namely rice, the grains of which are of a length exceeding 6,0 mm and of a length/width ratio greater than 2 but less than 3;
(ii) long grain rice B, namely rice, the grains of which are of a length exceeding 6,0 mm and of a length/width ratio equal to or greater than 3
Measurements of the grains means grain measurements on wholly milled rice taken by the following method:
(i) take a sample representative of the batch;
(ii) sieve the sample so as to retain only whole grains, including immature grains;
(iii) carry out two measurements of 100 grains each and work out the average;
(iv) express the result in millimetres, rounded off to one decimal place
Broken rice means grain fragments the length of which does not exceed three quarters of the average length of the whole grain
Whole grains means grains from which only part of the end has been removed, irrespective of characteristics produced at each stage of milling
Clipped grains means grains from which the entire end has been removed
Broken grains or fragments means grains from which a part of the volume greater than the end has been removed; broken grains include:
(i) large broken grains (pieces of grain of a length not less than half that of a grain, but not constituting a complete grain),
(ii) medium broken grains (pieces of grain of a length not less than a quarter of the length of a grain but which are smaller than the minimum size of 'large broken grains'),
(iii) fine broken grains (pieces of grain less than a quarter of the size of a grain but too large to pass through a sieve with a mesh of 1,4 mm),
(iv) fragments (small pieces or particles of grain which can pass through a sieve with a mesh of 1,4 mm); split grains (pieces produced by a longitudinal split in the grain) come under this definition
Green grains means grains which are not fully ripened
Grains showing natural malformation means grains showing a natural malformation, whether or not of hereditary origin, as compared with the morphological characteristics typical of the variety
Chalky grains means grains at least three-quarters of the surface of which looks opaque and chalky
Grains striated with red means grains showing longitudinal red striations of differing intensity and shades, due to residues from the pericarp
Spotted grains means grains showing a well-defined small circle of dark colour of more or less regular shape; spotted grains also include those which show slight black striations on the surface only; the striations and spots must not show a yellow or dark aureole
Stained grains means grains which have undergone, on a small area of their surface, an obvious change in their natural colour; the stains may be of different colours (blackish, reddish, brown); deep black striations are also to be regarded as stains. If the colour of the stains is sufficiently marked (black, pink, reddish-brown) to be immediately visible and if they cover an area not less than half that of the grain, the grains must be considered to be yellow grains
Yellow grains means grains which have undergone, totally or partially, otherwise than by drying, a change in their natural colour and have taken on a lemon or orange-yellow tone
Amber grains means grains which have undergone, otherwise than by drying, a slight uniform change in colour over the whole surface; this change alters the colour of the grains to a light amber-yellow
White sugars means sugars, not flavoured or coloured or containing any other added substances, containing, in the dry state, 99,5 % or more by weight of sucrose, determined by the polarimetric method
Raw sugars means sugars, not flavoured or coloured or containing any other added substances, containing, in the dry state, less than 99,5 % by weight of sucrose, determined by the polarimetric method
Isoglucose means the product obtained from glucose or its polymers, with a content by weight in the dry state of at least 10 % fructose
Inulin syrup means the immediate product obtained by hydrolysis of inulin or oligofructoses, containing in the dry state at least 10 % fructose in free form or as sucrose, and expressed as sugar/isoglucose equivalents. In order to avoid restrictions on the market for products with low sweetening power produced by inulin fibre processors without inulin syrup quota, this definition may be amended by the Commission by means of delegated acts pursuant to point (a) of Article 125(4)
delivery contract means a contract concluded between a seller and an undertaking for the delivery of beet for the manufacture of sugar
Agreement within the trade means one of the following:
(a) an agreement concluded, prior to the conclusion of any delivery contract, between undertakings or an undertakings' organisation recognised by the Member State concerned, or a group of such undertakings' organisations, on the one hand and a sellers' association recognised by the Member State concerned or a group of such sellers' organisations on the other;
(b) in the absence of any agreement as referred to in point (a), the law on companies and the law on cooperatives, in so far as they govern the delivery of sugar beet by the shareholders or members of a company or cooperative manufacturing sugar
Quota sugar”, “quota isoglucose” and “quota inulin syrup mean any quantity of sugar, isoglucose or inulin syrup production attributed to a specific marketing year under the quota of the undertaking concerned
Industrial sugar means any quantity of sugar production attributed to a specific marketing year over and above the sugar quantity referred to in point 5, intended for the production by the industry of one of the products referred to in Article 140(2)
Industrial isoglucose and industrial inulin syrup mean any quantity of isoglucose or inulin syrup production attributed to a specific marketing year, intended for the production by the industry of one of the products referred to in Article 140(2)
Surplus sugar, surplus isoglucose and surplus inulin syrup mean any quantity of sugar, isoglucose or inulin syrup production attributed to a specific marketing year over and above the respective quantities referred to in points 1, 2 and 3
Quota beet means all sugar beet processed into quota sugar
Full-time refiner means a production unit:
— of which the sole activity consists of refining imported raw cane sugar, or
— which refined in the marketing year 2004/2005 or, in the case of Croatia, 2007/2008 a quantity of at least 15 000 tonnes of imported raw cane sugar
Hops means the dried inflorescences, also known as cones, of the (female) climbing hop plant (Humulus lupulus); these inflorescences, which are greenish yellow and of an ovoid shape, have a flower stalk and their longest dimension generally varies from 2 to 5 cm
Hop powder means the product obtained by milling the hops, containing all the natural elements thereof
Hop powder with higher lupulin content means the product obtained by milling the hops after mechanical removal of a part of the leaves, stalks, bracts and rachides
Extract of hops means the concentrated products obtained by the action of a solvent on the hops or on the hop powder
Mixed hop products means a mixture of two or more of the products referred to in points 1 to 4
Grubbing up means the complete elimination of all vine stocks on an area planted with vines
Planting means the definitive establishment of vine plants or parts of vine plants, whether or not grafted, with a view to producing grapes or to establishing a graft nursery
Grafting-on means the grafting of a vine which has already been subject to a previous grafting
Fresh grapes means the fruit of the vine used in making wine, ripe or even slightly raisined, which may be crushed or pressed by normal wine-cellar means and which may spontaneously produce alcoholic fermentation
Fresh grape must with fermentation arrested by the addition of alcohol means a product which:
(a) has an actual alcoholic strength of not less than 12 % volume and not more than 15 % volume;
(b) is obtained by addition to unfermented grape must, which has a natural alcoholic strength of not less than 8,5 % volume and is exclusively derived from wine grape varieties classifiable in accordance with Article 81(2):
(i) either of neutral alcohol of vinous origin, including alcohol obtained from the distillation of dried grapes, having an actual alcoholic strength of not less than 96 % volume;
(ii) or of an unrectified product derived from the distillation of wine and having an actual alcoholic strength of not less than 52 % volume and not more than 80 % volume
Grape juice means the unfermented but fermentable liquid product which:
(a) is obtained by appropriate treatment rendering it fit for consumption as it is;
(b) is obtained from fresh grapes or from grape must or by reconstitution. Where obtained by reconstitution, it shall be reconstituted from concentrated grape must or concentrated grape juice.
An actual alcoholic strength of the grape juice of not more than 1 % volume is permissible
Concentrated grape juice means uncaramelised grape juice obtained by partial dehydration of grape juice carried out by any authorised method other than by direct heat in such a way that the figure indicated by a refractometer used in accordance with a method to be prescribed at a temperature of 20 °C is not less than 50,9 %. An actual alcoholic strength of the concentrated grape juice of not more than 1 % volume is permissible.
Wine lees means the residue:
(a) accumulating in vessels containing wine after fermentation, during storage or after authorised treatment;
(b) obtained from filtering or centrifuging the product referred to in (a);
(c) accumulating in vessels containing grape must during storage or after authorised treatment; or
(d) obtained from filtering or centrifuging the product referred to in (c)
Grape marc means the residue from the pressing of fresh grapes, whether or not fermented
Piquette means a product obtained by:
(a) the fermentation of untreated grape marc macerated in water; or
(b) leaching fermented grape marc with water
Wine fortified for distillation means a product which:
(a) has an actual alcoholic strength of not less than 18 % volume and not more than 24 % volume;
(b) is obtained exclusively by the addition to wine containing no residual sugar of an unrectified product derived from the distillation of wine and having a maximum actual alcoholic strength of 86 % volume; or
(c) has a maximum volatile acidity of 1,5 grams per litre, expressed as acetic acid
Cuvée means
(a) the grape must;
(b) the wine; or
(c) the mixture of grape musts and/or wines with different characteristics, intended for the preparation of a specific type of sparkling wine
Actual alcoholic strength by volume means the number of volumes of pure alcohol contained at a temperature of 20 °C in 100 volumes of the product at that temperature
Potential alcoholic strength by volume means the number of volumes of pure alcohol at a temperature of 20 °C capable of being produced by total fermentation of the sugars contained in 100 volumes of the product at that temperature
Total alcoholic strength by volume means the sum of the actual and potential alcoholic strengths
Natural alcoholic strength by volume means the total alcoholic strength by volume of a product before any enrichment
Actual alcoholic strength by mass means the number of kilograms of pure alcohol contained in 100 kilograms of product
Potential alcoholic strength by mass means the number of kilograms of pure alcohol capable of being produced by total fermentation of the sugars contained in 100 kilograms of product
Total alcoholic strength by mass means the sum of the actual and potential alcoholic strength
Bovine animals means live animals of the domestic bovine species falling within CN codes 0102 21 , ex 0102 31 00 , 0102 90 20 , ex 0102 29 10 to ex 0102 29 99 , 0102 39 10 , 0102 90 91
Eggs in shell means poultry eggs in shell, fresh, preserved, or cooked, other than eggs for hatching specified in point 2
Eggs for hatching means poultry eggs for hatching
Whole products means birds' eggs not in shell, whether or not containing added sugar or other sweetening matter suitable for human consumption
Separated products means birds' egg yolks, whether or not containing added sugar or other sweetening matter suitable for human consumption
Live poultry means live fowls, ducks, geese, turkeys and guinea fowls each weighing more than 185 grams
Chicks means live fowls, ducks, geese, turkeys and guinea fowls, each weighing not more than 185 grams
Slaughtered poultry means dead fowls of the species Gallus domesticus, ducks, geese, turkeys and guinea fowls, whole, with or without offal
Apiculture products means honey, beeswax, royal jelly, propolis or pollen
carcass means the whole body of a slaughtered animal as presented after bleeding, evisceration and skinning
half-carcass means the product obtained by separating the carcass symmetrically through the middle of each cervical, dorsal, lumbar and sacral vertebra and through the middle of the sternum and the ischiopubic symphysis
Carcass means the body of a slaughtered pig, bled and eviscerated, whole or divided down the mid-line
meat means all carcases, meat on the bone or boned, and offal, whether or not cut, intended for human consumption, obtained from bovine animals aged less than 12 months, presented fresh, frozen or deep-frozen, whether or not wrapped or packed
Wine means the product obtained exclusively from the total or partial alcoholic fermentation of fresh grapes, whether or not crushed, or of grape must
Retsina means wine produced exclusively in the geographical territory of Greece using grape must treated with resin from the Aleppo pine. The use of Aleppo pine resin is permitted solely for the purpose of obtaining "Retsina" wine under the conditions laid down in Greece's applicable provision
New wine still in fermentation means the product in which the alcoholic fermentation is not yet complete and which is not yet separated from its lees
Liqueur wine means the product:
(a) which has an actual alcoholic strength of not less than 15 % volume and not more than 22 % volume;
(b) which has a total alcoholic strength of not less than 17,5 % volume, except for certain liqueur wines with a designation of origin or with a geographical indication appearing on a list to be drawn up by the Commission by means of delegated acts pursuant to Article 75(2);
(c) which is obtained from:
— grape must in fermentation,
— wine,
— a combination of the above products, or
— grape must or a mixture thereof with wine for certain liqueur wines with a protected designation of origin or a protected geographical indication, to be determined by the Commission by means of delegated acts pursuant to Article 75(2);

(d) which has an initial natural alcoholic strength of not less than 12 % volume, except for certain liqueur wines with a protected designation of origin or a protected geographical indication appearing on a list to be drawn up by the Commission by means of delegated acts pursuant to Article 75(2);

(e) to which the following has been added:

(i) individually or in combination:

— neutral alcohol of vine origin, including alcohol produced from the distillation of dried grapes, having an actual alcoholic strength of not less than 96 % volume,

— wine or dried grape distillate, having an actual alcoholic strength of not less than 52 % volume and not more than 86 % volume;

(ii) together with one or more of the following products where appropriate:

— concentrated grape must,

— a combination of one of the products referred to in point (e)(i) with a grape must referred to in the first and fourth indent of point (c);

(f) to which, by way of derogation from point (e), has been added, in so far as certain liqueur wines with a protected designation of origin or a protected geographical indication are concerned which appear on a list to be drawn up by the Commission by means of delegated acts pursuant to Article 75(2):

(i) either of products listed in point (e)(i) individually or in combination; or

(ii) one or more of the following products:
— wine alcohol or dried grape alcohol with an actual alcoholic strength of not less than 95 % volume and not more than 96 % volume,
— spirits distilled from wine or from grape marc, with an actual alcoholic strength of not less than 52 % volume and not more than 86 % volume,
— spirits distilled from dried grapes, with an actual alcoholic strength of not less than 52 % volume and of less than 94,5 % volume; and
(iii) one or more of the following products, where appropriate:
— partially fermented grape must obtained from raisined grapes,
— concentrated grape must obtained by the action of direct heat, complying, with the exception of this operation, with the definition of concentrated grape must,
— concentrated grape must,
— a combination of one of the products listed in point (f)(ii) with a grape must referred to in the first and fourth indents of point (c)
Sparkling wine means the product:
(a) which is obtained by first or second alcoholic fermentation:
— from fresh grapes,
— from grape must, or
— from wine;
(b) which, when the container is opened, releases carbon dioxide derived exclusively from fermentation;
(c) which has an excess pressure, due to carbon dioxide in solution, of not less than 3 bar when kept at a temperature of 20 °C in closed containers; and
(d) for which the total alcoholic strength of the cuvées intended for their preparation shall not be less than 8,5 % volume
Quality sparkling wine means the product:
(a) which is obtained by first or second alcoholic fermentation:
— from fresh grapes,
— from grape must, or
— from wine;
(b) which, when the container is opened, releases carbon dioxide derived exclusively from fermentation;
(c) which has an excess pressure, due to carbon dioxide in solution, of not less than 3,5 bar when kept at a temperature of 20 °C in closed containers; and
(d) for which the total alcoholic strength of the cuvées intended for their preparation shall not be less than 9 % volume
Quality aromatic sparkling wine means the quality sparkling wine:
(a) which is obtained only by making use, when constituting the cuvée, of grape must or grape must in fermentation which is derived from specific wine grape varieties on a list to be drawn up by the Commission by means of delegated acts pursuant to Article 75(2).
Quality aromatic sparkling wines traditionally produced using wines when constituting the cuvée shall be determined by the Commission by means of delegated acts pursuant to in Article 75(2);
(b) which has an excess pressure, due to carbon dioxide in solution, of not less than 3 bar when kept at a temperature of 20 °C in closed containers;
(c) of which the actual alcoholic strength may not be less than 6 % volume; and
(d) of which the total alcoholic strength may not be less than 10 % volume
Aerated sparkling wine means the product which:
(a) is obtained from wine without a protected designation of origin or a protected geographical indication;
(b) releases, when the container is opened, carbon dioxide derived wholly or partially from an addition of that gas; and
(c) has an excess pressure, due to carbon dioxide in solution, of not less than 3 bar when kept at a temperature of 20 °C in closed containers
Semi-sparkling win means the product which:
(a) obtained from wine, new wine still in fermentation, grape must or grape must in fermentation in so far as these products have a total alcohol strength of at least 9 % vol;
(b) has an actual alcoholic strength of not less than 7 % volume;
(c) has an excess pressure, due to endogenous carbon dioxide in solution of not less than 1 bar and not more than 2,5 bar when kept at a temperature of 20 °C in closed containers; and
(d) is placed in containers of 60 litres or less
Aerated semi-sparkling wine means the product which:
(a) obtained from wine, new wine still in fermentation, grape must or grape must in fermentation;
(b) has an actual alcoholic strength of not less than 7 % volume and a total alcoholic strength of not less than 9 % volume;
(c) has an excess pressure of not less than 1 bar and not more than 2,5 bar when kept at a temperature of 20 °C in closed containers due to carbon dioxide in solution which has been wholly or partially added; and
(d) is placed in containers of 60 litres or less
Grape must means the liquid product obtained naturally or by physical processes from fresh grapes. An actual alcoholic strength of the grape must of not more than 1 % volume is permissible
Grape must in fermentation means the product obtained from the fermentation of grape must which has an actual alcoholic strength of more than 1 % volume but less than three fifths of its total alcoholic strength by volume
Grape must in fermentation extracted from raisined grapes means the product obtained from the partial fermentation of grape must obtained from raisined grapes, the total sugar content of which before fermentation is at least 272 grams per litre and the natural and actual alcoholic strength of which shall not be less than 8 % volume. However, certain wines, to be determined by the Commission by means of delegated acts pursuant to Article 75(2), that meet these requirements shall not be considered to be grape must in fermentation extracted from raisined grapes
Concentrated grape must means uncaramelised grape must which is obtained by partial dehydration of grape must carried out by any authorised method other than by direct heat in such a way that the figure indicated by a refractometer used in accordance with a method to be prescribed in accordance with the first subparagraph of Article 80(5) and point (d) of the first subparagraph of Article 91 at a temperature of 20 °C is not less than 50,9 %.
An actual alcoholic strength of the concentrated grape must of not more than 1 % volume is permissible.
Rectified concentrated grape must means:
(a) the liquid uncaramelised product which:
(i) is obtained by partial dehydration of grape must carried out by any authorised method other than direct heat in such a way that the figure indicated by a refractometer used according to a method to be prescribed in accordance with the first subparagraph of Article 80(5) and point (d) of the first subparagraph of Article 91 at a temperature of 20 °C is not less than 61,7 %;
(ii) has undergone authorised treatment for de-acidification and elimination of constituents other than sugar;
(iii) has the following characteristics:
— a pH of not more than 5 at 25 Brix,

— an optical density at 425 nm for a thickness of 1 cm of not more than 0,100 in grape must concentrated at 25 Brix,

— a sucrose content undetectable by a method of analysis to be defined,

— a Folin-Ciocalteu index of not more than 6,00 at 25 Brix,

— a titratable acidity of not more than 15 millequivalents per kilogram of total sugars,

— a sulphur dioxide content of not more than 25 milligrams per kilogram of total sugars,

— a total cation content of not more than 8 milliequivalents per kilogram of total sugars,

— a conductivity at 25 Brix and 20 °C of not more than 120 micro-Siemens/cm,

— a hydroxymethylfurfural content of not more than 25 milligrams per kilogram of total sugars,

— presence of mesoinositol.

(b) the solid uncaramelised product which:

(i) is obtained by crystallisation of liquid rectified concentrated grape must without the use of solvents;

(ii) has undergone authorised treatment for de-acidification and elimination of constituents other than sugar;

(iii) has the following characteristics after dilution in a solution at 25 Brix:

— a pH of not more than 7,5,

— an optical density at 425 nm for a thickness of 1 cm of not more than 0,100,

— a sucrose content undetectable by a method of analysis to be defined,

— a Folin-Ciocalteu index of not more than 6,00,

— a titratable acidity of not more than 15 millequivalents per kilogram of total sugars,

— a sulphur dioxide content of not more than 10 milligrams per kilogram of total sugars,

— a total cation content of not more than 8 millequivalents per kilogram of total sugars,

— a conductivity at 20 °C of not more than 120 micro-Siemens/cm,

— a hydroxymethylfurfural content of not more than 25 milligrams per kilogram of total sugars,

— presence of mesoinositol.

An actual alcoholic strength of the rectified concentrated grape must of not more than 1 % volume is permissible.
Wine from raisined grapes means the product which:
(a) is produced without enrichment, from grapes left in the sun or shade for partial dehydration;
(b) has a total alcoholic strength of at least 16 % volume and an actual alcoholic strength of at least 9 % volume; and
(c) has a natural alcoholic strength of a least 16 % volume (or 272 grams sugar/litre)
Wine of overripe grapes means the product which:
(a) is produced without enrichment;
(b) has a natural alcoholic strength of more than 15 % volume; and
(c) has a total alcoholic strength of not less than 15 % volume and an actual alcoholic strength of not less than 12 % volume
Wine vinegar means vinegar which:
(a) is obtained exclusively by acetous fermentation of wine; and
(b) has a total acidity of not less than 60 grams per litre expressed as acetic acid
(a) for milk treated without altering its composition or for milk the fat content of which is standardised under Part IV;
(b) in association with a word or words to designate the type, grade, origin and/or intended use of such milk or to describe the physical treatment or the modification in composition to which it has been subjected, provided that the modification is restricted to an addition and/or withdrawal of natural milk constituents">Milk means exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom.
However, the term "milk" may be used:
(a) for milk treated without altering its composition or for milk the fat content of which is standardised under Part IV;
(b) in association with a word or words to designate the type, grade, origin and/or intended use of such milk or to describe the physical treatment or the modification in composition to which it has been subjected, provided that the modification is restricted to an addition and/or withdrawal of natural milk constituents
milk products means products derived exclusively from milk, on the understanding that substances necessary for their manufacture may be added provided that those substances are not used for the purpose of replacing, in whole or in part, any milk constituent
milk means the produce of the milking of one or more cows
drinking milk means the products referred to in point III intended for delivery without further processing to the consumer
fat content means the ratio by mass of parts of milk fat per hundred parts of milk in the milk concerned
protein content means the ratio by mass of parts of protein per hundred parts of milk in the milk concerned (obtained by multiplying by 6,38 the total nitrogen content of the milk expressed as a percentage by mass)
poultrymeat means poultrymeat suitable for human consumption, which has not undergone any treatment other than cold treatment
fresh poultrymeat means poultrymeat which has not been stiffened at any time by the cooling process prior to being kept at a temperature not below – 2 °C and not higher than + 4 °C. However, Member States may lay down slightly different temperature requirements for the minimum length of time necessary for the cutting and handling of fresh poultrymeat performed in retail shops or in premises adjacent to sales points, where the cutting and handling are performed solely for the purpose of supplying the consumer directly on the spot
frozen poultrymeat means poultrymeat which must be frozen as soon as possible within the constraints of normal slaughtering procedures and is to be kept at a temperature no higher than – 12 °C at any time
quick-frozen poultrymeat means poultrymeat which is to be kept at a temperature no higher than – 18 °C at any time within the tolerances as provided for in Council Directive 89/108/EEC
poultrymeat preparation means poultrymeat including poultrymeat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat
fresh poultrymeat preparation means a poultrymeat preparation for which fresh poultrymeat has been used
cream means the product obtained from milk in the form of an emulsion of the oil-in-water type with a milk-fat content of at least 10 %
Virgin olive oils mean oils obtained from the fruit of the olive tree solely by mechanical or other physical means under conditions that do not lead to alterations in the oil, which have not undergone any treatment other than washing, decantation, centrifugation or filtration, to the exclusion of oils obtained using solvents or using adjuvants having a chemical or biochemical action, or by re-esterification process and any mixture with oils of other kinds
Extra virgin olive oil means virgin olive oil having a maximum free acidity in terms of oleic acid, of 0,8 g per 100 g, the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Virgin olive oil means virgin olive oil having a maximum free acidity in terms of oleic acid, of 2 g per 100 g, the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Lampante olive oil means virgin olive oil having a free acidity in terms of oleic acid, of more than 2 g per 100 g, and/or the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Refined olive oil means olive oil obtained by refining virgin olive oil, having a free acidity content, expressed as oleic acid, of not more than 0,3 g per 100 g, and the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Olive oils composed of refined olive oils and virgin olive oils means olive oil obtained by blending refined olive oil and virgin olive oil other than lampante olive oil, having a free acidity content, expressed as oleic acid, of not more than 1 g per 100 g, and the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Crude olive-pomace oil means oil obtained from olive pomace by treatment with solvents or by physical means or oil corresponding to lampante olive oil, except for certain specified characteristics, excluding oil obtained by means of re-esterification and mixtures with other types of oils, and the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Refined olive-pomace oil means oil obtained by refining crude olive-pomace oil, having free acidity content, expressed as oleic acid, of not more than 0,3 g per 100 g, and the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
Olive-pomace oil means oil obtained by blending refined olive-pomace oil and virgin olive oil other than lampante olive oil, having a free acidity content, expressed as oleic acid, of not more than 1 g per 100 g, and the other characteristics of which comply with those laid down by the Commission in accordance with Article 75(2) for this category
merger of undertakings means the consolidation of two or more undertakings into a single undertaking
transfer of an undertaking means the transfer or absorption of the assets of an undertaking having quota to one or more undertakings
transfer of a factory means the transfer of ownership of a technical unit, including all the plant required to manufacture the product concerned, to one or more undertakings, resulting in the partial or total absorption of the production of the undertaking making the transfer
lease of a factory means the leasehold contract of a technical unit including all the plant required for the manufacture of sugar, with a view to its operation, concluded for a period of at least three consecutive marketing years, which the parties agree not to terminate before the end of the third marketing year, with an undertaking which is established in the same Member State as the factory concerned, if, after the lease takes effect, the undertaking which rents the factory can be considered to be a solely sugar-producing undertaking for its entire production
electronic communications network means transmission systems, whether or not based on a permanent infrastructure or centralised administration capacity, and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the conveyance of signals by wire, radio, optical or other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched, including internet) and mobile networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed
very high capacity network means either an electronic communications network which consists wholly of optical fibre elements at least up to the distribution point at the serving location, or an electronic communications network which is capable of delivering, under usual peak-time conditions, similar network performance in terms of available downlink and uplink bandwidth, resilience, error-related parameters, and latency and its variation; network performance can be considered similar regardless of whether the end-user experience varies due to the inherently different characteristics of the medium by which the network ultimately connects with the network termination point
transnational markets means markets identified in accordance with Article 65, which cover the Union or a substantial part thereof located in more than one Member Stat
electronic communications service means a service normally provided for remuneration via electronic communications networks, which encompasses, with the exception of services providing, or exercising editorial control over, content transmitted using electronic communications networks and services, the following types of services:
(a) ‘internet access service’ as defined in point (2) of the second paragraph of Article 2 of Regulation (EU) 2015/2120;
(b) interpersonal communications service; and
(c) services consisting wholly or mainly in the conveyance of signals such as transmission services used for the provision of machine-to-machine services and for broadcasting;
interpersonal communications service means a service normally provided for remuneration that enables direct interpersonal and interactive exchange of information via electronic communications networks between a finite number of persons, whereby the persons initiating or participating in the communication determine its recipient(s) and does not include services which enable interpersonal and interactive communication merely as a minor ancillary feature that is intrinsically linked to another service
number-based interpersonal communications service means an interpersonal communications service which connects with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which enables communication with a number or numbers in national or international numbering plans
number-independent interpersonal communications service means an interpersonal communications service which does not connect with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which does not enable communication with a number or numbers in national or international numbering plans
public electronic communications network means an electronic communications network used wholly or mainly for the provision of publicly available electronic communications services which support the transfer of information between network termination points
network termination point means the physical point at which an end-user is provided with access to a public electronic communications network, and which, in the case of networks involving switching or routing, is identified by means of a specific network address, which may be linked to an end-user’s number or name
associated facilities means associated services, physical infrastructures and other facilities or elements associated with an electronic communications network or an electronic communications service which enable or support the provision of services via that network or service, or have the potential to do so, and include buildings or entries to buildings, building wiring, antennae, towers and other supporting constructions, ducts, conduits, masts, manholes, and cabinets
associated service means a service associated with an electronic communications network or an electronic communications service which enables or supports the provision, self-provision or automated-provision of services via that network or service, or has the potential to do so, and includes number translation or systems offering equivalent functionality, conditional access systems and electronic programme guides (EPGs), as well as other services such as identity, location and presence service
conditional access system means any technical measure, authentication system and/or arrangement whereby access to a protected radio or television broadcasting service in intelligible form is made conditional upon subscription or another form of prior individual authorisation
user means a natural or legal person using or requesting a publicly available electronic communications service
end-user means a user not providing public electronic communications networks or publicly available electronic communications services
consume means any natural person who uses or requests a publicly available electronic communications service for purposes which are outside his or her trade, business, craft or profession
provision of an electronic communications network means the establishment, operation, control or making available of such a network
enhanced digital television equipment means set-top boxes intended for connection to television sets or integrated digital television sets, able to receive digital interactive television services
application programming interface or API means the software interface between applications, made available by broadcasters or service providers, and the resources in the enhanced digital television equipment for digital television and radio services
radio spectrum allocation means the designation of a given radio spectrum band for use by one or more types of radio communications services, where appropriate, under specified conditions
harmful interference means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with the applicable international, Union or national regulations
security of networks and services means the ability of electronic communications networks and services to resist, at a given level of confidence, any action that compromises the availability, authenticity, integrity or confidentiality of those networks and services, of stored or transmitted or processed data, or of the related services offered by, or accessible via, those electronic communications networks or services
general authorisation means a legal framework established by a Member State ensuring rights for the provision of electronic communications networks or services and laying down sector-specific obligations that may apply to all or to specific types of electronic communications networks and services, in accordance with this Directive
small-area wireless access point means low-power wireless network access equipment of a small size operating within a small range, using licenced radio spectrum or licence-exempt radio spectrum or a combination thereof, which may be used as part of a public electronic communications network, which may be equipped with one or more low visual impact antennae, and which allows wireless access by users to electronic communications networks regardless of the underlying network topology, be it mobile or fixed
radio local area network or RLAN means low-power wireless access system, operating within a small range, with a low risk of interference with other such systems deployed in close proximity by other users, using, on a non-exclusive basis, harmonised radio spectrum
harmonised radio spectrum means radio spectrum for which harmonised conditions relating to its availability and efficient use have been established by way of technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC
shared use of radio spectrum means access by two or more users to use the same radio spectrum bands under a defined sharing arrangement, authorised on the basis of a general authorisation, individual rights of use for radio spectrum or a combination thereof, including regulatory approaches such as licensed shared access aiming to facilitate the shared use of a radio spectrum band, subject to a binding agreement of all parties involved, in accordance with sharing rules as included in their rights of use for radio spectrum in order to guarantee to all users predictable and reliable sharing arrangements, and without prejudice to the application of competition law
access means the making available of facilities or services to another undertaking, under defined conditions, either on an exclusive or a non-exclusive basis, for the purpose of providing electronic communications services, including when they are used for the delivery of information society services or broadcast content services; it covers, inter alia: access to network elements and associated facilities, which may involve the connection of equipment, by fixed or non-fixed means (in particular this includes access to the local loop and to facilities and services necessary to provide services over the local loop); access to physical infrastructure including buildings, ducts and masts; access to relevant software systems including operational support systems; access to information systems or databases for pre-ordering, provisioning, ordering, maintaining and repair requests, and billing; access to number translation or systems offering equivalent functionality; access to fixed and mobile networks, in particular for roaming; access to conditional access systems for digital television services and access to virtual network services
interconnection means a specific type of access implemented between public network operators by means of the physical and logical linking of public electronic communications networks used by the same or a different undertaking in order to allow the users of one undertaking to communicate with users of the same or another undertaking, or to access services provided by another undertaking where such services are provided by the parties involved or other parties who have access to the network
operator means an undertaking providing or authorised to provide a public electronic communications network or an associated facility
local loop means the physical path used by electronic communications signals connecting the network termination point to a distribution frame or equivalent facility in the fixed public electronic communications network
call means a connection established by means of a publicly available interpersonal communications service allowing two-way voice communication
voice communications service means a publicly available electronic communications service for originating and receiving, directly or indirectly, national or national and international calls through a number or numbers in a national or international numbering plan
geographic number means a number from the national numbering plan where part of its digit structure contains geographic significance used for routing calls to the physical location of the network termination point
non-geographic number means a number from the national numbering plan that is not a geographic number, such as mobile, freephone and premium-rate numbers
total conversation service means a multimedia real time conversation service that provides bidirectional symmetric real time transfer of motion video, real time text and voice between users in two or more locations
public safety answering point or PSAP means a physical location where an emergency communication is first received under the responsibility of a public authority or a private organisation recognised by the Member State
most appropriate PSAP established by responsible authorities to cover emergency communications from a certain area or for emergency communications of a certain type
emergency communication means communication by means of interpersonal communications services between an end-user and the PSAP with the goal to request and receive emergency relief from emergency services
emergency service means a service, recognised as such by the Member State, that provides immediate and rapid assistance in situations where there is, in particular, a direct risk to life or limb, to individual or public health or safety, to private or public property, or to the environment, in accordance with national law
caller location information means, in a public mobile network, the data processed, derived from network infrastructure or handsets, indicating the geographic position of an end-user’s mobile terminal equipment, and, in a public fixed network, the data about the physical address of the network termination point
security incident means an event having an actual adverse effect on the security of electronic communications networks or services
regulated intra-EU communications means any number-based interpersonal communications service originating in the Member State of the consumer’s domestic provider and terminating at any fixed or mobile number of the national numbering plan of another Member State, and which is charged wholly or partly based on actual consumption
food information means information concerning a food and made available to the final consumer by means of a label, other accompanying material, or any other means including modern technology tools or verbal communication
food information law means the Union provisions governing the food information, and in particular labelling, including rules of a general nature applicable to all foods in particular circumstances or to certain categories of foods and rules which apply only to specific foods
mandatory food information means the particulars that are required to be provided to the final consumer by Union provisions
mass caterer means any establishment (including a vehicle or a fixed or mobile stall), such as restaurants, canteens, schools, hospitals and catering enterprises in which, in the course of a business, food is prepared to be ready for consumption by the final consumer
prepacked food means any single item for presentation as such to the final consumer and to mass caterers, consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, but in any event in such a way that the contents cannot be altered without opening or changing the packaging; ‘prepacked food’ does not cover foods packed on the sales premises at the consumer’s request or prepacked for direct sale
ingredient means any substance or product, including flavourings, food additives and food enzymes, and any constituent of a compound ingredient, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; residues shall not be considered as ‘ingredients’
place of provenance means any place where a food is indicated to come from, and that is not the ‘country of origin’ as determined in accordance with Articles 23 to 26 of Regulation (EEC) No 2913/92; the name, business name or address of the food business operator on the label shall not constitute an indication of the country of origin or place of provenance of food within the meaning of this Regulation
compound ingredient means an ingredient that is itself the product of more than one ingredient
label means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to the packaging or container of food
labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food
field of vision means all the surfaces of a package that can be read from a single viewing point
principal field of vision means the field of vision of a package which is most likely to be seen at first glance by the consumer at the time of purchase and that enables the consumer to immediately identify a product in terms of its character or nature and, if applicable, its brand name. If a package has several identical principal fields of vision, the principal field of vision is the one chosen by the food business operator
legibility means the physical appearance of information, by means of which the information is visually accessible to the general population and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background
legal name means the name of a food prescribed in the Union provisions applicable to it or, in the absence of such Union provisions, the name provided for in the laws, regulations and administrative provisions applicable in the Member State in which the food is sold to the final consumer or to mass caterers
customary name means a name which is accepted as the name of the food by consumers in the Member State in which that food is sold, without that name needing further explanation
descriptive name means a name providing a description of the food, and if necessary of its use, which is sufficiently clear to enable consumers to know its true nature and distinguish it from other products with which it might be confused
primary ingredient means an ingredient or ingredients of a food that represent more than 50 % of that food or which are usually associated with the name of the food by the consumer and for which in most cases a quantitative indication is required
date of minimum durability of a food means the date until which the food retains its specific properties when properly stored
nutrient means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in point 1 of Part A of Annex XIII to this Regulation, and substances which belong to or are components of one of those categories
means of distance communication means any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the conclusion of a contract between those parties
nutrition declaration or nutrition labelling means information stating the:
(a) energy value; or
(b) energy value and one or more of the following nutrients only:
— fat (saturates, mono-unsaturates, polyunsaturates),
— carbohydrate (sugars, polyols, starch),
— salt,
— fibre,
— protein,
— any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII
fat means total lipids, and includes phospholipids
saturates means fatty acids without double bond
trans fat means fatty acids with at least one non-conjugated (namely interrupted by at least one methylene group) carbon-carbon double bond in the trans configuration
mono-unsaturates means fatty acids with one cis double bond
polyunsaturates means fatty acids with two or more cis, cis-methylene interrupted double bonds
carbohydrate means any carbohydrate which is metabolised by humans, and includes polyols
sugars means all monosaccharides and disaccharides present in food, but excludes polyols
polyols means alcohols containing more than two hydroxyl groups
protein means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25
salt means the salt equivalent content calculated using the formula: salt = sodium × 2,5
fibre means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the human small intestine and belong to the following categories:
— edible carbohydrate polymers naturally occurring in the food as consumed,
— edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientific evidence,
— edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence
average value means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary
in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
(a) concerning a physiological or pathological process or state;
(b) concerning congenital physical or mental impairments;
(c) concerning the predisposition to a medical condition or a disease;
(d) to determine the safety and compatibility with potential recipients;
(e) to predict treatment response or reactions;
(f) to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices
specimen receptacle means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examinatio
accessory for an in vitro diagnostic medical device means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s)
device for self-testing means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services
device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional
companion diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:
(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
(b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product
generic device group means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics
single-use device means a device that is intended to be used during a single procedure
falsified device means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights
kit means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof
intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation
label means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices
instructions for use means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken
Unique Device Identifier (UDI) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market
risk means the combination of the probability of occurrence of harm and the severity of that harm
benefit-risk determination means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer
compatibility is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
(a) perform without losing or compromising the ability to perform as intended, and/or
(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse reaction
interoperability is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
(a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
(b) communicate with each other, and/or
(c) work together as intended
making available on the market means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a device, other than a device for performance study, on the Union market
putting into service means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose
manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark
fully refurbishing for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device
authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation
importer means any natural or legal person established within the Union that places a device from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service
economic operator means a manufacturer, an authorised representative, an importer or a distributor
health institution means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health
user means any healthcare professional or lay person who uses a device
lay person means an individual who does not have formal education in a relevant field of healthcare or medical discipline
conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled
conformity assessment body means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection
notified body means a conformity assessment body designated in accordance with this Regulation
CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing
clinical evidence means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer
clinical benefit means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health
scientific validity of an analyte means the association of an analyte with a clinical condition or a physiological state
performance of a device means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose
analytical performance means the ability of a device to correctly detect or measure a particular analyte
clinical performance means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user
performance study means a study undertaken to establish or confirm the analytical or clinical performance of a device
performance study plan means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study
performance evaluation means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device
device for performance study means a device intended by the manufacturer to be used in a performance study.
A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study
interventional clinical performance study means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment
subject means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes
investigator means an individual responsible for the conduct of a performance study at a performance study sit
diagnostic specificity means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition
diagnostic sensitivity means the ability of a device to identify the presence of a target marker associated with a particular disease or condition
predictive value means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition
positive predictive value means the ability of a device to separate true positive results from false positive results for a given attribute in a given population
negative predictive value means the ability of a device to separate true negative results from false negative results for a given attribute in a given population
likelihood ratio means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state
calibrator means a measurement reference material used in the calibration of a device
control material means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device
sponsor means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study
informed consent means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study
ethics committee means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations
adverse event means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study
serious adverse event means any adverse event that led to any of the following:
(a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,
(b) death,
(c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
(v) chronic disease,
(d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect
device deficiency means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer
post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions
market surveillance means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection
recall means any measure aimed at achieving the return of a device that has already been made available to the end user
withdrawal means any measure aimed at preventing a device in the supply chain from being further made available on the market
incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device
serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
(c) a serious public health threat
serious public health threat means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation
field safety corrective action means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market
field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action
common specifications (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system
farmer means a natural or legal person, or a group of natural or legal persons, regardless of the legal status granted to such group and its members by national law, whose holding is situated within the territorial scope of the Treaties, as defined in Article 52 TEU in conjunction with Articles 349 and 355 TFEU, and who exercises an agricultural activity
holding means all the units used for agricultural activities and managed by a farmer situated within the territory of the same Member State
agricultural activity means:
(i) production, rearing or growing of agricultural products, including harvesting, milking, breeding animals, and keeping animals for farming purposes,
(ii) maintaining an agricultural area in a state which makes it suitable for grazing or cultivation without preparatory action going beyond usual agricultural methods and machineries, based on criteria established by Member States on the basis of a framework established by the Commission, or
(iii) carrying out a minimum activity, defined by Member States, on agricultural areas naturally kept in a state suitable for grazing or cultivation
agricultural products means the products, with the exception of fishery products, listed in Annex I to the Treaties as well as cotton
agricultural area means any area taken up by arable land, permanent grassland and permanent pasture, or permanent crops
arable land means land cultivated for crop production or areas available for crop production but lying fallow, including areas set aside in accordance with Articles 22, 23 and 24 of Regulation (EC) No 1257/1999, with Article 39 of Regulation (EC) No 1698/2005 and with Article 28 of Regulation (EU) No 1305/2013, irrespective of whether or not that land is under greenhouses or under fixed or mobile cover
permanent crops means non-rotational crops other than permanent grassland and permanent pasture that occupy the land for five years or more and yield repeated harvests, including nurseries and short rotation coppice
permanent grassland and permanent pasture means land used to grow grasses or other herbaceous forage naturally (self-seeded) or through cultivation (sown) and that has not been included in the crop rotation of the holding for five years or more, as well as, where Member States so decide, that has not been ploughed up for five years or more; it may include other species such as shrubs and/or trees which can be grazed and, where Member States so decide, other species such as shrubs and/or trees which produce animal feed, provided that the grasses and other herbaceous forage remain predominant. Member States may also decide to consider as permanent grassland:
(i) land which can be grazed and which forms part of established local practices where grasses and other herbaceous forage are traditionally not predominant in grazing areas; and/or
(ii) land which can be grazed where grasses and other herbaceous forage are not predominant or are absent in grazing areas
grasses or other herbaceous forage means all herbaceous plants traditionally found in natural pastures or normally included in mixtures of seeds for pastures or meadows in the Member State, whether or not used for grazing animals
nurseries means the following areas of young ligneous (woody) plants grown in the open air for subsequent transplantation:
— vine and root-stock nurseries,
— fruit tree and berries nurseries,
— ornamental nurseries,
— commercial nurseries of forest trees excluding those for the holding's own requirements grown within woodland,
— nurseries of trees and bushes for planting in gardens, parks, at the roadside and on embankments (e.g. hedgerow plants, rose trees and other ornamental bushes, ornamental conifers), including in all cases their stocks and young seedlings
short rotation coppice means areas planted with tree species of CN code 0602 90 41 to be defined by Member States that consist of woody, perennial crops, the rootstock or stools of which remain in the ground after harvesting, with new shoots emerging in the following season and with a maximum harvest cycle to be determined by the Member States
sale means the sale or any other definitive transfer of ownership of land or payment entitlements; it does not include the sale of land where land is transferred to public authorities or for use in the public interest and where the transfer is carried out for non-agricultural purposes
lease means a rental agreement or similar temporary transaction
transfer means the lease or sale or actual inheritance or anticipated inheritance of land or payment entitlements or any other definitive transfer thereof; it does not cover the reversion of entitlements upon expiry of a lease
young farmers means farmers fulfilling the conditions laid down in Article 50(2) and, where relevant, the conditions referred to in Article 50(3) and (11)
farmers commencing their agricultural activity means natural or legal persons who, in the five years preceding the start of the agricultural activity, did not have any agricultural activity in their own name and at their own risk or did not have the control of a legal person exercising an agricultural activity. In the case of a legal person, the natural person or persons in control of the legal person must not have had any agricultural activity in their own name and at their own risk or must not have had the control of a legal person exercising an agricultural activity in the five years preceding the start of the agricultural activity by the legal person; Member States may establish their own additional objective and non-discriminative eligibility criteria for this category of farmers as regards appropriate skills, experience or education
eligible hectare means:
(a) any agricultural area of the holding, including areas that were not in good agricultural condition on 30 June 2003 in Member States acceding to the Union on 1 May 2004 that opted upon accession to apply the single area payment scheme, that is used for an agricultural activity or, where the area is also used for non-agricultural activities, is predominantly used for agricultural activities; or
(b) any area which gave a right to payments in 2008 under the single payment scheme or the single area payment scheme laid down, respectively, in Titles III and IVA of Regulation (EC) No 1782/2003, and which:
(i) no longer complies with the definition of 'eligible hectare' under point (a) as a result of the implementation of Directive 92/43/EEC, Directive 2000/60/EC and Directive 2009/147/EC;
(ii) for the duration of the relevant commitment by the individual farmer, is afforested pursuant to Article 31 of Regulation (EC) No 1257/1999 or to Article 43 of Regulation (EC) No 1698/2005 or to Article 22 of Regulation (EU) No 1305/2013 or under a national scheme the conditions of which comply with Article 43(1), (2) and (3) of Regulation (EC) No 1698/2005 or Article 22 of Regulation (EU) No 1305/2013; or
(iii) for the duration of the relevant commitment of the individual farmer, is set aside pursuant to Articles 22, 23 and 24 of Regulation (EC) No 1257/1999, to Article 39 of Regulation (EC) No 1698/2005 or to Article 28 of Regulation (EU) No 1305/2013
crop means any of the following:
(a) a culture of any of the different genera defined in the botanical classification of crops;
(b) a culture of any of the species in the case of Brassicaceae, Solanaceae, and Cucurbitaceae;
(c) land lying fallow;
(d) grasses or other herbaceous forage.
Winter crop and spring crop shall be considered to be distinct crops even if they belong to the same genus. Triticum spelta shall be considered to be a distinct crop from crops belonging to the same genus
areas of permanent grassland means the land under permanent pasture declared in 2012, or 2013 in the case of Croatia, in accordance with Regulation (EC) No 73/2009 by the farmers subject to the obligations under this Chapter, as well as the areas of permanent grassland declared in 2015 in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 by the farmers subject to the obligations under this Chapter that have not been declared as land under permanent pasture in 2012 or, in the case of Croatia, 2013
total agricultural area means the agricultural area declared in 2015 in accordance with point (a) of the first subparagraph of Article 72(1) of Regulation (EU) No 1306/2013 by farmers subject to the obligations under this Chapter
young farmers means natural persons:
(a) who are setting up for the first time an agricultural holding as head of the holding, or who have already set up such a holding during the five years preceding the first submission of an application under the basic payment scheme or the single area payment scheme referred to in Article 72(1) of Regulation (EU) No 1306/2013; and
(b) who are no more than 40 years of age in the year of submission of the application referred to in point (a)
approved interbranch organisation means a legal entity made up of farmers producing cotton and at least one ginner, carrying out activities such as:
(a) helping to better coordinate the way cotton is placed on the market, particularly through research studies and market surveys;
(b) drawing up standard forms of contract compatible with Union rules;
(c) orienting production towards products that are better adapted to market needs and consumer demand, particularly in terms of quality and consumer protection;
(d) updating methods and means to improve product quality;
(e) developing marketing strategies to promote cotton via quality certification schemes
plants means living plants and the following living parts of plants:
(a) seeds, in the botanical sense, other than those not intended for planting;
(b) fruits, in the botanical sense;
(c) vegetables;
(d) tubers, corms, bulbs, rhizomes, roots, rootstocks, stolons;
(e) shoots, stems, runners;
(f) cut flowers;
(g) branches with or without foliage;
(h) cut trees retaining foliage;
(i) leaves, foliage;
(j) plant tissue cultures, including cell cultures, germplasm, meristems, chimaeric clones, micro-propagated material;
(k) live pollen and spores;
(l) buds, budwood, cuttings, scions, grafts
plant products means unmanufactured material of plant origin and those manufactured products that, by their nature or that of their processing, may create a risk of the spread of quarantine pests.
Except where otherwise provided in the implementing acts adopted pursuant to Articles 28, 30 and 41, wood shall only be considered as a plant product if it fulfils one or more of the following criteria:
(a) it retains all or part of its natural round surface, with or without bark;
(b) it has not retained its natural round surface due to sawing, cutting or cleaving;
(c) it is in the form of chips, particles, sawdust, wood waste, shavings or scrap, and has not undergone processing involving the use of glue, heat or pressure or a combination thereof to produce pellet, briquettes, plywood or particle board;
(d) it is, or is intended to be, used as packaging material, whether or not it is actually in use for transport of goods
planting means any operation for the placing of plants in a growing medium, or by grafting or similar operations, to ensure their subsequent growth, reproduction or propagation
plants for planting means plants intended to remain planted, to be planted or to be replanted
other object means any material or object, other than plants or plant products, capable of harbouring or spreading pests, including soil or growing medium
lot means a number of units of a single commodity, identifiable by its homogeneity of composition, origin and other relevant elements, forming part of a consignment
trade unit means the smallest commercial or other useable unit applicable to the marketing stage concerned, which may be the subset or the whole of a lot
professional operator means any person, governed by public or private law, involved professionally in, and legally responsible for, one or more of the following activities concerning plants, plant products and other objects:
(a) planting;
(b) breeding;
(c) production, including growing, multiplying and maintaining;
(d) introduction into, and movement within and out of, the Union territory;
(e) making available on the market;
(f) storage, collection, dispatching and processing
registered operator means a professional operator registered in accordance with Article 65
authorised operator means a registered operator authorised by the competent authority to issue plant passports in accordance with Article 89, to apply a mark in accordance with Article 98, or to issue attestations in accordance with Article 99
final user means any person acting for purposes which are outside that person's trade, business or profession who acquires plants or plant products for personal use
test means an official examination, other than visual, to determine if pests are present or to identify pests
treatment means a procedure, whether official or non-official, for the killing, inactivation or removal of pests, or for rendering those pests infertile, or for the devitalisation of plants or plant products
incidence means the proportion or number of units in which a pest is present in a sample, consignment, field or other defined population
establishment means the perpetuation, for the foreseeable future, of a pest within an area after entry
eradication means the application of phytosanitary measures to eliminate a pest from an area
containment means the application of phytosanitary measures in and around an infested area to prevent the spread of a pest
quarantine station means any official station for holding pests, plants, plant products or other objects in quarantine
confinement facility means any facility, other than quarantine stations, where pests, plants, plant products or other objects are kept under confinement conditions
traceability code means a letter, numerical or alphanumerical code that identifies a consignment, lot or trade unit, used for traceability purposes, including codes referring to a lot, batch, series, date of production or professional operator documents
phytosanitary measure means any official measure having the purpose to prevent the introduction or spread of quarantine pests or to limit the economic impact of regulated non-quarantine pests
activity data means the data on the amount of fuels or materials consumed or produced by a process as relevant for the calculation-based monitoring methodology, expressed in terajoules, mass in tonnes, or for gases as volume in normal cubic metres, as appropriate
trading period means an eight-year period referred to in Article 13(1) of Directive 2003/87/EC
tonne-kilometre means a tonne of payload carried a distance of one kilometre
source stream means any of the following:
(a) a specific fuel type, raw material or product giving rise to emissions of relevant greenhouse gases at one or more emission sources as a result of its consumption or production;
(b) a specific fuel type, raw material or product containing carbon and included in the calculation of greenhouse gas emissions using a mass balance methodology"
emission source means a separately identifiable part of an installation or a process within an installation, from which relevant greenhouse gases are emitted or, for aviation activities, an individual aircraft
uncertainty means a parameter, associated with the result of the determination of a quantity, that characterises the dispersion of the values that could reasonably be attributed to the particular quantity, including the effects of systematic as well as of random factors, expressed in per cent, and describes a confidence interval around the mean value comprising 95 % of inferred values taking into account any asymmetry of the distribution of values
calculation factors means net calorific value, emission factor, preliminary emission factor, oxidation factor, conversion factor, carbon content or biomass fraction
tier means a set requirement used for determining activity data, calculation factors, annual emission and annual average hourly emission, as well as for payload
inherent risk means the susceptibility of a parameter in the annual emissions report or tonne-kilometre data report to misstatements that could be material, individually or when aggregated with other misstatements, before taking into consideration the effect of any related control activities
control risk means the susceptibility of a parameter in the annual emissions report or tonne-kilometre report to misstatements that could be material, individually or when aggregated with other misstatements, and not prevented or detected and corrected on a timely basis by the control system
combustion emissions means greenhouse gas emissions occurring during the exothermic reaction of a fuel with oxygen
reporting period means one calendar year during which emissions have to be monitored and reported, or the monitoring year as referred to in Articles 3e and 3f of Directive 2003/87/EC for tonne-kilometre data
emission factor means the average emission rate of a greenhouse gas relative to the activity data of a source stream assuming complete oxidation for combustion and complete conversion for all other chemical reactions
oxidation factor means the ratio of carbon oxidised to CO2 as a consequence of combustion to the total carbon contained in the fuel, expressed as a fraction, considering CO emitted to the atmosphere as the molar equivalent amount of CO2
conversion factor means the ratio of carbon emitted as CO2 to the total carbon contained in the source stream before the emitting process takes place, expressed as a fraction, considering carbon monoxide (CO) emitted to the atmosphere as the molar equivalent amount of CO2
accuracy means the closeness of the agreement between the result of a measurement and the true value of the particular quantity or a reference value determined empirically using internationally accepted and traceable calibration materials and standard methods, taking into account both random and systematic factors
calibration means the set of operations, which establishes, under specified conditions, the relations between values indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material and the corresponding values of a quantity realised by a reference standard
passengers means the persons onboard the aircraft during a flight excluding its on duty crew members
conservative means that a set of assumptions is defined in order to ensure that no under-estimation of annual emissions or over-estimation of tonne-kilometres occurs
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste; it includes bioliquids and biofuels
bioliquids means liquid fuel for energy purposes other than for transport, including electricity and heating and cooling, produced from biomass
biofuels means liquid or gaseous fuel for transport produced from biomass
legal metrological control means the control of the measurement tasks intended for the field of application of a measuring instrument, for reasons of public interest, public health, public safety, public order, protection of the environment, levying of taxes and duties, protection of the consumers and fair trading
maximum permissible error means the error of measurement allowed as specified in Annex I and instrument-specific Annexes to Directive 2004/22/EC of the European Parliament and of the Council ( 1 ), or national rules on legal metrological control, as appropriate
data flow activities mean activities related to the acquisition, processing and handling of data that are needed to draft an emissions report from primary source data
tonnes of CO2(e) means metric tonnes of CO2 or CO2(e)
CO2(e) means any greenhouse gas, other than CO2 listed in Annex II to Directive 2003/87/EC with an equivalent global-warming potential as CO2
measurement system means a complete set of measuring instruments and other equipment, such as sampling and data processing equipment, used for the determination of variables like the activity data, the carbon content, the calorific value or the emission factor of the CO2 emissions
net calorific value (NCV) means the specific amount of energy released as heat when a fuel or material undergoes complete combustion with oxygen under standard conditions less the heat of vaporisation of any water formed
process emissions means greenhouse gas emissions other than combustion emissions occurring as a result of intentional and unintentional reactions between substances or their transformation, including the chemical or electrolytic reduction of metal ores, the thermal decomposition of substances, and the formation of substances for use as product or feedstock
commercial standard fuel means the internationally standardised commercial fuels which exhibit a 95 % confidence interval of not more than 1 % for their specified calorific value, including gas oil, light fuel oil, gasoline, lamp oil, kerosene, ethane, propane, butane, jet kerosene (jet A1 or jet A), jet gasoline (Jet B) and aviation gasoline (AvGas)
batch means an amount of fuel or material representatively sampled and characterised and transferred as one shipment or continuously over a specific period of time
mixed fuel means a fuel which contains both biomass and fossil carbon
mixed material means a material which contains both biomass and fossil carbon
preliminary emission factor means the assumed total emission factor of a mixed fuel or material based on the total carbon content composed of biomass fraction and fossil fraction before multiplying it with the fossil fraction to result in the emission factor
fossil fraction means the ratio of fossil carbon to the total carbon content of a fuel or material, expressed as a fraction
biomass fraction means the ratio of carbon stemming from biomass to the total carbon content of a fuel or material, expressed as a fraction
energy balance method means a method to estimate the amount of energy used as fuel in a boiler, calculated as sum of utilisable heat and all relevant losses of energy by radiation, transmission and via the flue gas
continuous emission measurement means a set of operations having the objective of determining the value of a quantity by means of periodic measurements, applying either measurements in the stack or extractive procedures with a measuring instrument located close to the stack, whilst excluding measurement methodologies based on the collection of individual samples from the stack
inherent CO2 means CO2 which is part of a fuel
fossil carbon means inorganic and organic carbon that is not biomass
measurement point means the emission source for which continuous emission measurement systems (CEMS) are used for emission measurement, or the cross-section of a pipeline system for which the CO2 flow is determined using continuous measurement systems
mass and balance documentation means the documentation as specified in international or national implementation of the Standards and Recommended Practices (SARPs), as laid down in Annex 6 to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944, and as specified in Subpart J Annex III to Council Regulation (EEC) No 3922/91 ( 2 ), or equivalent applicable international rules
distance means the Great Circle Distance between the aerodrome of departure and the aerodrome of arrival, in addition to a fixed factor of 95 km
aerodrome of departure means the aerodrome at which a flight constituting an aviation activity listed in Annex I to Directive 2003/87/EC begins
aerodrome of arrival means the aerodrome at which a flight constituting an aviation activity listed in Annex I to Directive 2003/87/EC ends
payload means the total mass of freight, mail, passengers and baggage carried onboard the aircraft during a flight
fugitive emissions means irregular or unintended emissions from sources which are not localised, or too diverse or too small to be monitored individually
aerodrome pair means a pair constituted by the aerodrome of departure and the aerodrome of arrival
standard conditions means temperature of 273,15 K and pressure conditions of 101 325 Pa defining normal cubic metres (Nm3)
CO2 capture means the activity of capturing from gas streams carbon dioxide (CO2), which would otherwise be emitted, for the purposes of transport and geological storage in a storage site permitted under Directive 2009/31/EC
CO2 transport means the transport of CO2 by pipelines for geological storage in a storage site permitted under Directive 2009/31/EC
vented emissions means emissions deliberately released from the installation by provision of a defined point of emission
enhanced hydrocarbon recovery means the recovery of hydrocarbons in addition to those extracted by water injection or other means
proxy data means annual values which are empirically substantiated or derived from accepted sources and which an operator uses to substitute the activity data or the calculation factors for the purpose of ensuring complete reporting when it is not possible to generate all the required activity data or calculation factors in the applicable monitoring methodology
energy means all forms of energy products, combustible fuels, heat, renewable energy, electricity, or any other form of energy, as defined in Article 2(d) of Regulation (EC) No 1099/2008 of the European Parliament and of the Council of 22 October 2008 on energy statistics ( 1 )
primary energy consumption means gross inland consumption, excluding non-energy uses
final energy consumption means all energy supplied to industry, transport, households, services and agriculture. It excludes deliveries to the energy transformation sector and the energy industries themselves
energy efficiency means the ratio of output of performance, service, goods or energy, to input of energy
energy savings means an amount of saved energy determined by measuring and/or estimating consumption before and after implementation of an energy efficiency improvement measure, whilst ensuring normalisation for external conditions that affect energy consumption
energy efficiency improvement means an increase in energy efficiency as a result of technological, behavioural and/or economic changes
energy service means the physical benefit, utility or good derived from a combination of energy with energy-efficient technology or with action, which may include the operations, maintenance and control necessary to deliver the service, which is delivered on the basis of a contract and in normal circumstances has proven to result in verifiable and measurable or estimable energy efficiency improvement or primary energy savings
public bodies means ‘contracting authorities’ as defined in Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts ( 2 )
central government means all administrative departments whose competence extends over the whole territory of a Member State
total useful floor area means the floor area of a building or part of a building, where energy is used to condition the indoor climate
energy management system means a set of interrelated or interacting elements of a plan which sets an energy efficiency objective and a strategy to achieve that objective
European standard means a standard adopted by the European Committee for Standardisation, the European Committee for Electrotechnical Standardisation or the European Telecommunications Standards Institute and made available for public use
international standard means a standard adopted by the International Standardisation Organisation and made available to the public
obligated party means an energy distributor or retail energy sales company that is bound by the national energy efficiency obligation schemes referred to in Article 7
entrusted party means a legal entity with delegated power from a government or other public body to develop, manage or operate a financing scheme on behalf of the government or other public body
participating party means an enterprise or public body that has committed itself to reaching certain objectives under a voluntary agreement, or is covered by a national regulatory policy instrument
implementing public authority means a body governed by public law which is responsible for the carrying out or monitoring of energy or carbon taxation, financial schemes and instruments, fiscal incentives, standards and norms, energy labelling schemes, training or education
policy measure means a regulatory, financial, fiscal, voluntary or information provision instrument formally established and implemented in a Member State to create a supportive framework, requirement or incentive for market actors to provide and purchase energy services and to undertake other energy efficiency improvement measures
individual action means an action that leads to verifiable, and measurable or estimable, energy efficiency improvements and is undertaken as a result of a policy measure
energy distributor means a natural or legal person, including a distribution system operator, responsible for transporting energy with a view to its delivery to final customers or to distribution stations that sell energy to final customers
retail energy sales company means a natural or legal person who sells energy to final customers
final customer means a natural or legal person who purchases energy for own end use
energy service provider means a natural or legal person who delivers energy services or other energy efficiency improvement measures in a final customer’s facility or premises
energy audit means a systematic procedure with the purpose of obtaining adequate knowledge of the existing energy consumption profile of a building or group of buildings, an industrial or commercial operation or installation or a private or public service, identifying and quantifying cost-effective energy savings opportunities, and reporting the findings
small and medium-sized enterprises or SMEs means enterprises as defined in Title I of the Annex to Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 3 ); the category of micro, small and medium-sized enterprises is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million
energy performance contracting means a contractual arrangement between the beneficiary and the provider of an energy efficiency improvement measure, verified and monitored during the whole term of the contract, where investments (work, supply or service) in that measure are paid for in relation to a contractually agreed level of energy efficiency improvement or other agreed energy performance criterion, such as financial savings
smart metering system’ or ‘intelligent metering system means an electronic system that can measure energy consumption, providing more information than a conventional meter, and can transmit and receive data using a form of electronic communication
cogeneration means the simultaneous generation in one process of thermal energy and electrical or mechanical energy
economically justifiable demand means demand that does not exceed the needs for heating or cooling and which would otherwise be satisfied at market conditions by energy generation processes other than cogeneration
useful heat means heat produced in a cogeneration process to satisfy economically justifiable demand for heating or cooling
electricity from cogeneration means electricity generated in a process linked to the production of useful heat and calculated in accordance with the methodology laid down in Annex I
high-efficiency cogeneration means cogeneration meeting the criteria laid down in Annex II
overall efficiency means the annual sum of electricity and mechanical energy production and useful heat output divided by the fuel input used for heat produced in a cogeneration process and gross electricity and mechanical energy production
power-to-heat ratio means the ratio of electricity from cogeneration to useful heat when operating in full cogeneration mode using operational data of the specific unit
cogeneration unit means a unit that is able to operate in cogeneration mode
small-scale cogeneration unit means a cogeneration unit with installed capacity below 1 MWe
micro-cogeneration unit means a cogeneration unit with a maximum capacity below 50 kWe
plot ratio means the ratio of the building floor area to the land area in a given territory
efficient district heating and cooling means a district heating or cooling system using at least 50 % renewable energy, 50 % waste heat, 75 % cogenerated heat or 50 % of a combination of such energy and heat
efficient heating and cooling means a heating and cooling option that, compared to a baseline scenario reflecting a business-as-usual situation, measurably reduces the input of primary energy needed to supply one unit of delivered energy within a relevant system boundary in a cost-effective way, as assessed in the cost-benefit analysis referred to in this Directive, taking into account the energy required for extraction, conversion, transport and distribution
efficient individual heating and cooling means an individual heating and cooling supply option that, compared to efficient district heating and cooling, measurably reduces the input of non-renewable primary energy needed to supply one unit of delivered energy within a relevant system boundary or requires the same input of non-renewable primary energy but at a lower cost, taking into account the energy required for extraction, conversion, transport and distribution
substantial refurbishment means a refurbishment whose cost exceeds 50 % of the investment cost for a new comparable unit
aggregator means a demand service provider that combines multiple short-duration consumer loads for sale or auction in organised energy markets
master means the person having command of a ship
officer means a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom
deck officer means an officer qualified in accordance with the provisions of Chapter II of Annex I
chief mate means the officer next in rank to the master upon whom the command of the ship will fall in the event of the incapacity of the master
engineer officer means an officer qualified in accordance with the provisions of Chapter III of Annex I
chief engineer officer means the senior engineer officer responsible for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship
second engineer officer means the engineer officer next in rank to the chief engineer officer upon whom the responsibility for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship will fall in the event of the incapacity of the chief engineer officer
assistant engineer officer means a person under training to become an engineer officer and designated as such by national law or regulations
radio operator means a person holding an appropriate certificate issued or recognised by the competent authorities under the provisions of the Radio Regulations
rating means a member of the ship’s crew other than the master or an officer
seagoing ship means a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply
ship flying the flag of a Member State means a ship registered in and flying the flag of a Member State in accordance with its legislation; a ship not corresponding to this definition shall be regarded as a ship flying the flag of a third country
near-coastal voyages means voyages in the vicinity of a Member State as defined by that Member State
propulsion power means the total maximum continuous rated output power in kilowatts of all of a ship’s main propulsion machinery which appears on the ship’s certificate of registry or other official document
oil-tanker means a ship constructed and used for the carriage of petroleum and petroleum products in bulk
chemical tanker means a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code, in its up-to-date version
quefied-gas tanker means a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code, in its up-to-date version
Radio Regulations means the radio regulations annexed to, or regarded as being annexed to, the International Telecommunication Convention, as amended
passenger ship means a ship as defined in the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74), as amended
fishing vessel shall mean a vessel used for catching fish or other living resources of the sea
STCW Convention means the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW Code, all being applied in their up-to-date versions
radio duties includes, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74) and, at the discretion of each Member State, the relevant recommendations of the IMO, in their up-to-date versions
ro-ro passenger ship means a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the SOLAS 74, in its up-to-date version
STCW Code means the Seafarers’ Training, Certification and Watchkeeping (STCW) Code as adopted by the 1995 Conference resolution 2, in its up-to-date version
function means a group of tasks, duties and responsibilities, as specified in the STCW Code, necessary for ship operation, safety of life at sea or protection of the marine environment
company means the owner of the ship or any other organisation or person such as the manager or the bareboat charterer who has assumed the responsibility for operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed on the company by this Directive
seagoing service means service on board a ship relevant to the issue or revalidation of a certificate of competency, certificate of proficiency or other qualification
approved means approved by a Member State in accordance with this Directive
third country means any country which is not a Member State
month means a calendar month or 30 days made up of periods of less than one month
GMDSS radio operator means a person qualified in accordance with Chapter IV of Annex I
ISPS Code means the International Ship and Port Facility Security Code adopted on 12 December 2002, by resolution 2 of the Conference of Contracting Governments to the SOLAS 74, in its up-to-date version
ship security officer means the person on board a ship, accountable to the master, designated by the company as responsible for the security of the ship including implementation and maintenance of the ship security plan and liaison with the company security officer and port facility security officers
security duties include all security tasks and duties on board ships as defined by Chapter XI/2 of the SOLAS 74, as amended, and by the ISPS Code
certificate of competency means a certificate issued and endorsed for masters, officers and GMDSS radio operators in accordance with Chapters II, III, IV or VII of Annex I, and entitling the lawful holder thereof to serve in the capacity and perform the functions involved at the level of responsibility specified therein
certificate of proficiency means a certificate, other than a certificate of competency, issued to a seafarer stating that the relevant requirements of training, competencies or sea-going service in this Directive have been met
documentary evidence means documentation, other than a certificate of competency or certificate of proficiency, used to establish that the relevant requirements in this Directive have been met
electro-technical officer means an officer qualified in accordance with Chapter III of Annex I
able seafarer deck means a rating qualified in accordance with Chapter II of Annex I
able seafarer engine means a rating qualified in accordance with Chapter III of Annex I
electro-technical rating means a rating qualified in accordance with Chapter III of Annex I
host Member State means the Member State in which seafarers seek acceptance or recognition of their certificates of competency, certificates of proficiency or documentary evidence
IGF Code means the International Code of Safety for Ships using Gases or other Low-flashpoint Fuels, as defined in SOLAS 74 Regulation II-1/2.29
Polar Code means the International Code for Ships Operating in Polar Waters, as defined in SOLAS 74 Regulation XIV/1.1
Polar waters means Arctic waters and/or the Antarctic area, as defined in SOLAS 74 Regulations XIV/1.2 to XIV/1.4.
ro-ro passenger ship means a ship with facilities to enable road or rail vehicles to roll on and roll off the vessel, and carrying more than 12 passengers
high-speed passenger craft means a craft as defined in Regulation 1 of Chapter X of SOLAS 74, and carrying more than 12 passengers
SOLAS 74 means the 1974 International Convention for the Safety of Life at Sea, including Protocols and amendments thereto, in its up-to-date version
High Speed Craft Code means the ‘International Code of Safety for High Speed Craft’ contained in IMO Maritime Safety Committee Resolution MSC.36(63) of 20 May 1994 or the International Code of Safety for High-Speed Craft, 2000 (2000 HSC Code), contained in IMO Resolution MSC.97(73) of December 2000, in its up-to-date version
HSSC means the IMO Survey Guidelines under the Harmonized System of Survey and Certification, in its up-to-date version
regular service means a series of ro-ro passenger ship or high-speed passenger craft crossings operated so as to serve traffic between the same two or more ports, or a series of voyages from and to the same port without intermediate calls, either:
(a) according to a published timetable; or
(b) with crossings so regular or frequent that they constitute a recognisable systematic series
sea area means any sea area or sea route established pursuant to Article 4 of Directive 2009/45/EC
‘certificates means:
(a) for ro-ro passenger ships and high-speed passenger craft engaged on international voyages, the safety certificates issued under SOLAS 74 or under the High Speed Craft Code respectively, together with the relevant attached records of equipment;
(b) for ro-ro passenger ships and high-speed passenger craft engaged on domestic voyages, the safety certificates issued in accordance with Directive 2009/45/EC together with the relevant attached records of equipment
administration of the flag State means the competent authorities of the State whose flag the ro-ro passenger ship or the high-speed passenger craft is entitled to fly
domestic voyage means a voyage in sea areas from a port of a Member State to the same or another port within that Member State
company means the organisation or person who has agreed to take over all the duties and responsibilities imposed by the International Management Code for Safe Operation of Ships and for Pollution Prevention (the ISM Code) in its up-to- date version or, in cases where Chapter IX of SOLAS 74 does not apply, the owner of the ro-ro passenger ship or the high-speed passenger craft or any other organisation or person such as the manager, or the bareboat charterer, who has assumed the responsibility for operation of the ro-ro passenger ship or the high-speed passenger craft from its owner
inspector means a public-sector employee or other person, duly authorised by the competent authority of a Member State to carry out the inspections provided for in this Directive, who is responsible to that competent authority and who fulfills the minimum criteria specified in Annex XI to Directive 2009/16/EC
competent authority of the Member State means the authority appointed by the Member State under this Directive and responsible for carrying out the tasks assigned to it by this Directive
ship means a seagoing vessel of any type operating in the marine environment, including fishing vessels, recreational craft, hydrofoil boats, air-cushion vehicles, submersibles and floating craft
MARPOL Convention means the International Convention for the Prevention of Pollution from Ships, in its up-to-date version
waste from ships means all waste, including cargo residues, which is generated during the service of a ship or during loading, unloading and cleaning operations and which falls within the scope of Annexes I, II, IV, V and VI to MARPOL Convention, as well as passively fished waste
passively fished waste means waste collected in nets during fishing operations
cargo residues means the remnants of any cargo material on board which remain on the deck or in holds or tanks following loading and unloading, including loading and unloading excess or spillage, whether in wet or dry condition or entrained in wash-water, excluding cargo dust remaining on the deck after sweeping or dust of the external surfaces of the ship
port reception facility means any facility which is fixed, floating or mobile and capable of providing the service of receiving the waste from ships
fishing vesse means any ship equipped or used commercially for catching fish or other living resources from the sea
recreational craft means a ship of any type, with a hull length of 2,5 metres or more, regardless of the means of propulsion, intended for sports or leisure purposes, and not engaged in trade
port means a place or a geographical area made up of such improvement works and equipment designed principally to permit the reception of ships, including the anchorage area within the jurisdiction of the port
sufficient storage capacity means enough capacity to store the waste on board from the moment of departure until the next port of call, including the waste that is likely to be generated during the voyage
scheduled traffic means traffic based on a published or planned list of times of departures and arrivals between identified ports or recurrent crossings that constitute a recognised schedule
regular port calls means repeated voyages of the same ship forming a constant pattern between identified ports or a series of voyages from and to the same port without intermediate calls
frequent port calls means visits by a ship to the same port taking place at least once a fortnight
GISIS means the Global Integrated Shipping Information System set up by the IMO
treatment means recovery or disposal operations, including preparation prior to recovery or disposal
indirect fee means a fee paid for the provision of port reception facility services, irrespective of the actual delivery of waste from ships
emission means the discharge of substances from a combustion plant into the air
emission limit value means the permissible quantity of a substance contained in the waste gases from a combustion plant which may be discharged into the air during a given period
nitrogen oxides (NOx) means nitric oxide and nitrogen dioxide, expressed as nitrogen dioxide (NO2)
dust means particles, of any shape, structure or density, dispersed in the gas phase at the sampling point conditions which may be collected by filtration under specified conditions after representative sampling of the gas to be analysed, and which remain upstream of the filter and on the filter after drying under specified conditions
combustion plant means any technical apparatus in which fuels are oxidised in order to use the heat thus generated
existing combustion plant means a combustion plant put into operation before 20 December 2018 or for which a permit was granted before 19 December 2017 pursuant to national legislation provided that the plant is put into operation no later than 20 December 2018
new combustion plant means a combustion plant other than an existing combustion plant
engine means a gas engine, diesel engine or dual fuel engine
gas engine means an internal combustion engine which operates according to the Otto cycle and uses spark ignition to burn fuel
diesel engine means an internal combustion engine which operates according to the Diesel cycle and uses compression ignition to burn fuel
dual fuel engine means an internal combustion engine which uses compression ignition and operates according to the Diesel cycle when burning liquid fuels and according to the Otto cycle when burning gaseous fuels
gas turbine means any rotating machine which converts thermal energy into mechanical work, consisting mainly of a compressor, a thermal device in which fuel is oxidised in order to heat the working fluid, and a turbine; this includes both open cycle and combined cycle gas turbines, and gas turbines in cogeneration mode, all with or without supplementary firing
small isolated system (SIS) means a small isolated system as defined in point 26 of Article 2 of Directive 2009/72/EC of the European Parliament and of the Council
micro isolated system (MIS) means a micro isolated system as defined in point 27 of Article 2 of Directive 2009/72/EC
fuel means any solid, liquid or gaseous combustible material
refinery fuel means solid, liquid or gaseous combustible material from the distillation and conversion steps of the refining of crude oil, including refinery fuel gas, syngas, refinery oils and pet coke
waste means waste as defined in point 1 of Article 3 of Directive 2008/98/EC of the European Parliament and of the Council
biomass means any of the following:
(a) products consisting of any vegetable matter from agriculture or forestry which can be used as a fuel for the purpose of recovering its energy content;
(b) the following waste:
(i) vegetable waste from agriculture and forestry;
(ii) vegetable waste from the food processing industry, if the heat generated is recovered;
(iii) fibrous vegetable waste from virgin pulp production and from production of paper from pulp, if it is co-incinerated at the place of production and the heat generated is recovered;
(iv) cork waste;
(v) wood waste with the exception of wood waste which may contain halogenated organic compounds or heavy metals as a result of treatment with wood preservatives or coating and which includes, in particular, such wood waste originating from construction and demolition waste
gas oil means:

(a)

any petroleum-derived liquid fuel falling within CN codes 2710 19 25, 2710 19 29, 2710 19 47, 2710 19 48, 2710 20 17 or 2710 20 19; or

(b)

any petroleum-derived liquid fuel of which less than 65 % by volume (including losses) distils at 250 °C and of which at least 85 % by volume (including losses) distils at 350 °C by the ASTM D86 method
natural gas means naturally occurring methane with no more than 20 % (by volume) of inerts and other constituents
heavy fuel oil means:
(a) any petroleum-derived liquid fuel falling within CN codes 2710 19 51 to 2710 19 68, 2710 20 31, 2710 20 35, or 2710 20 39; or
(b) any petroleum-derived liquid fuel, other than gas oil as defined in point 19, which, by reason of its distillation limits, falls within the category of heavy oils intended for use as fuel and of which less than 65 % by volume (including losses) distils at 250 °C by the ASTM D86 method. If the distillation cannot be determined by the ASTM D86 method, the petroleum product is likewise categorised as a heavy fuel oil
operating hours means the time, expressed in hours, during which a combustion plant is operating and discharging emissions into the air, excluding start-up and shut-down periods
operator means any natural or legal person who operates or controls the combustion plant, or, where this is provided for in national law, to whom decisive economic power over the technical functioning of the plant has been delegated
zone means part of the territory of a Member State, as delimited by that Member State for the purposes of air quality assessment and management, as laid down in Directive 2008/50/EC.
propagating material means parts of plants and all plant material, including rootstocks intended for the propagation and production of vegetables;
planting material means entire plants and parts of plants including, for grafted plants, the grafted components, intended for planting for the production of vegetables
supplier means any natural or legal person carrying out professionally at least one of the following activities with regard to vegetable propagating and planting material: reproducing, producing, preserving and/or treating and marketing
marketing means the holding available or in stock, displaying or offering for sale, selling and/or delivering to another person, in whatever form, of propagating or planting material
responsible official body means:
(i) the sole and central authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning quality;
(ii) any State authority established:
— either at national level,
— or at regional level, under the supervision of the national authorities within the limits set by the national legislation of the Member State concerned.
The bodies referred to in (i) and (ii) may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or private law, which, under its officially approved statute, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes.
The Member States shall ensure that there is close cooperation between the bodies referred to in (i) and those referred to in (ii).
Moreover, in accordance with the procedure referred to in Article 21(2), another legal person established on behalf of any body referred to in (i) and (ii) and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes.
The Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States
official measures means measures taken by the responsible official body
official inspection means an inspection carried out by the responsible official body
official statement means a statement issued by, or under the responsibility of, the responsible official body
lot means a number of units of a single commodity, identifiable by its homogeneity of composition and origin
laboratory means a public or private law entity carrying out analysis and proper diagnosis, enabling the producer to monitor production quality
making available on the market means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a product on the Union market
market surveillance means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation
market surveillance authority means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State
applicant authority means the market surveillance authority that makes a request for mutual assistance
requested authority means the market surveillance authority that receives a request for mutual assistance
non-compliance means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation
manufacturer means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark
importer means any natural or legal person established within the Union who places a product from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
fulfilment service provider means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport services
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation
economic operator means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation
information society service provider means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council
online interface means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products
corrective action means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative
voluntary measure means a corrective action where not required by a market surveillance authority
risk means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm
product presenting a risk means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements
product presenting a serious risk means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate
end user means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities
recall means any measure aimed at achieving the return of a product that has already been made available to the end user
withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market
products entering the Union market means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’
building means a roofed construction having walls, for which energy is used to condition the indoor climate
nearly zero-energy building means a building that has a very high energy performance, as determined in accordance with Annex I. The nearly zero or very low amount of energy required should be covered to a very significant extent by energy from renewable sources, including energy from renewable sources produced on-site or nearby
technical building system means technical equipment for space heating, space cooling, ventilation, domestic hot water, built-in lighting, building automation and control, on-site electricity generation, or a combination thereof, including those systems using energy from renewable sources, of a building or building unit
building automation and control system means a system comprising all products, software and engineering services that can support energy efficient, economical and safe operation of technical building systems through automatic controls and by facilitating the manual management of those technical building systems
energy performance of a building means the calculated or measured amount of energy needed to meet the energy demand associated with a typical use of the building, which includes, inter alia, energy used for heating, cooling, ventilation, hot water and lighting
primary energy means energy from renewable and non-renewable sources which has not undergone any conversion or transformation process
energy from renewable sources means energy from renewable non-fossil sources, namely wind, solar, aerothermal, geothermal, hydrothermal and ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases
building envelope means the integrated elements of a building which separate its interior from the outdoor environment
building unit means a section, floor or apartment within a building which is designed or altered to be used separately
building element means a technical building system or an element of the building envelope
major renovation means the renovation of a building where:
(a) the total cost of the renovation relating to the building envelope or the technical building systems is higher than 25 % of the value of the building, excluding the value of the land upon which the building is situated; or
(b) more than 25 % of the surface of the building envelope undergoes renovation;
Member States may choose to apply option (a) or (b)
European standard means a standard adopted by the European Committee for Standardisation, the European Committee for Electrotechnical Standardisation or the European Telecommunications Standards Institute and made available for public use
energy performance certificate means a certificate recognised by a Member State or by a legal person designated by it, which indicates the energy performance of a building or building unit, calculated according to a methodology adopted in accordance with Article 3
cogeneration means simultaneous generation in one process of thermal energy and electrical and/or mechanical energy
cost-optimal level means the energy performance level which leads to the lowest cost during the estimated economic lifecycle, where:
(a) the lowest cost is determined taking into account energy-related investment costs, maintenance and operating costs (including energy costs and savings, the category of building concerned, earnings from energy produced), where applicable, and disposal costs, where applicable; and
(b) the estimated economic lifecycle is determined by each Member State. It refers to the remaining estimated economic lifecycle of a building where energy performance requirements are set for the building as a whole, or to the estimated economic lifecycle of a building element where energy performance requirements are set for building elements.
The cost-optimal level shall lie within the range of performance levels where the cost benefit analysis calculated over the estimated economic lifecycle is positive
air-conditioning system means a combination of the components required to provide a form of indoor air treatment, by which temperature is controlled or can be lowered
heating system means a combination of the components required to provide a form of indoor air treatment, by which the temperature is increased
heat generator means the part of a heating system that generates useful heat using one or more of the following processes:
(a) the combustion of fuels in, for example, a boiler;
(b) the Joule effect, taking place in the heating elements of an electric resistance heating system;
(c) capturing heat from ambient air, ventilation exhaust air, or a water or ground heat source using a heat pump
boiler means the combined boiler body-burner unit, designed to transmit to fluids the heat released from burning
effective rated output means the maximum calorific output, expressed in kW, specified and guaranteed by the manufacturer as being deliverable during continuous operation while complying with the useful efficiency indicated by the manufacturer
heat pump means a machine, a device or installation that transfers heat from natural surroundings such as air, water or ground to buildings or industrial applications by reversing the natural flow of heat such that it flows from a lower to a higher temperature. For reversible heat pumps, it may also move heat from the building to the natural surroundings
district heating or district cooling means the distribution of thermal energy in the form of steam, hot water or chilled liquids, from a central source of production through a network to multiple buildings or sites, for the use of space or process heating or cooling
ventilation unit (VU) means an electricity driven appliance equipped with at least one impeller, one motor and a casing and intended to replace utilised air by outdoor air in a building or a part of a building
non-residential ventilation unit (NRVU) means a ventilation unit where:
(a) the maximum flow rate does not exceed 250 m3/h;
(b) the maximum flow rate is between 250 and 1 000 m3/h, and the manufacturer declares its intended use as being exclusively for a residential ventilation application"
non-residential ventilation unit (NRVU) means a ventilation unit where the maximum flow rate of the ventilation unit exceeds 250 m3/h, and, where the maximum flow rate is between 250 and 1 000 m3/h, the manufacturer has not declared its intended use as being exclusively for a residential ventilation application
maximum flow rate is the declared maximum air volume flow rate of a ventilation unit that can be achieved with integrated or separately co-supplied controls at standard air conditions (20 °C) and 101 325 Pa, where the unit is installed complete (e.g. including clean filters) and according to the manufacturer's instructions, for ducted RVUs the maximum flow is related to the air flow at 100 Pa of external static pressure difference, and for non-ducted RVUs to the air flow at the lowest achievable total pressure difference to be chosen from a set of values of 10 (minimum)-20-50-100-150-200-250 Pa, whichever is equal or just below the measured pressure difference value
unidirectional ventilation unit (UVU) means a ventilation unit producing an air flow in one direction only, either from indoors to outdoors (exhaust) or from outdoors to indoors (supply), where the mechanically produced air flow is balanced by natural air supply or exhaust
bidirectional ventilation unit (BVU) means a ventilation unit which produces an air flow between indoors and outdoors and is equipped with both exhaust and supply fans
equivalent ventilation unit model means a ventilation unit with the same technical characteristics according to the applicable product information requirements, but placed on the market as a different ventilation unit model by the same manufacturer, authorised representative or importer
specific energy consumption (SEC) (expressed in kWh/(m2.a)) means a coefficient to express the energy consumed for ventilation per m2 heated floor area of a dwelling or building, calculated for RVUs in accordance with Annex VIII
sound power level (LWA) means the casing-radiated A-weighted sound power level expressed in decibels (dB) with reference to the sound power of one picowatt (1pW), transmitted by the air at reference airflow
multi-speed drive means a fan motor that can be operated at three or more fixed speeds plus zero (‘off’)
variable speed drive (VSD) means an electronic controller, integrated or functioning as one system or as a separate delivery with the motor and the fan, which continuously adapts the electrical power supplied to the motor in order to control the flow rate
heat recovery system (HRS) means the part of a bidirectional ventilation unit equipped with a heat exchanger designed to transfer the heat contained in the (contaminated) exhaust air to the (fresh) supply air
thermal efficiency of a residential HRS (ηt) means the ratio between supply air temperature gain and exhaust air temperature loss, both relative to the outdoor temperature, measured under dry conditions of the HRS, and standard air conditions, with balanced mass flow, at reference flow rate, an indoor-outdoor temperature difference of 13 K, no correction for thermal heat gain from fan motors
internal leakage rate means the fraction of extract air present in the supply air of ventilation units with HRS as a result of leakage between extract and supply airflows inside the casing when the unit is operated at reference air volume flow, measured at the ducts; the test shall be performed for RVUs at 100 Pa, and for NRVUs at 250 Pa
carry over means the percentage of the exhaust air which is returned to the supply air for a regenerative heat exchanger according to the reference flow
external leakage rate means the leakage fraction of the reference air volume flow to or from the inside of the casing of a unit to or from the surrounding air when it is subjected to a pressure test; the test shall be performed at 250 Pa for RVUs and at 400 Pa for NRVUs, for both under and over pressure
mixing means the immediate recirculation or short-circuiting of airflows between discharge and intake ports at both the indoor and outdoor terminals so that they do not contribute to the effective ventilation of a building space, when the unit is operated at reference air volume rate
mixing rate means the fraction of extract airflow, as part of the total reference air volume, that recirculates between discharge and intake ports at both the indoor and outdoor terminals and thus does not contribute to the effective ventilation of a building space, when the unit is operated at reference air volume (measured at 1 m distance from the indoor supply duct), less the internal leakage rate
effective power input (expressed in W) means the electric power input at reference flow rate and corresponding external total pressure difference and includes the electrical demand for fans, controls (including remote controls) and the heat pump (if integrated)
specific power input (SPI) (expressed in W/(m3/h)) means the ratio between the effective power input (in W) and the reference flow rate (in m3/h)
flow rate/pressure diagram means a set of curves for flow rate (horizontal axis) and pressure difference of a unidirectional RVU or the supply side of a bidirectional RVU, where each curve represents one fan speed with at least eight equidistant test-points and the number of curves is given by the number of discrete fan speed options (one, two or three) or, in the case of a variable fan speed drive, includes at least a minimum, maximum and appropriate intermediate curve close to the reference air volume and pressure difference for SPI testing
reference flow rate (expressed in m3/s) is the abscissa value to a point on a curve in the flow rate/pressure diagram which is on or closest to a reference point at 70 % at least of the maximum flow rate and 50 Pa for ducted units and at a minimum pressure for non-ducted units. For bidirectional ventilation units, the reference air volume flow rate applies to the air supply outlet
control factor (CTRL) means a correction factor for the SEC calculation depending on the type of control that is part of the ventilation unit, according to the description in Annex VIII Table 1
control parameter means a measurable parameter or set of measurable parameters that are assumed to be representative of the ventilation demand, e.g. the level of relative humidity (RH), carbon dioxide (CO2), volatile organic compounds (VOC) or other gases, presence, motion or occupancy detection from infrared body heat or from reflection of ultrasonic waves, electrical signals from human operation of lights or equipment
manual control means any control type that does not use demand control
demand control means a device or set of devices, integrated or as a separate delivery, that measures a control parameter and uses the result to regulate automatically the flow rate of the unit and/or the flow rates of the ducts
clock control means a clocked (daytime-controlled) human interface to control the fan speed/flow rate of the ventilation unit, with at least seven weekday manual settings of the adjustable flow rate for at least two setback periods, i.e. periods in which a reduced or no flow rate applies
demand controlled ventilation (DCV) means a ventilation unit that uses demand control
ducted unit means a ventilation unit intended to ventilate one or more rooms or enclosed space in a building through the use of air ducts, intended to be equipped with duct connections
non-ducted unit means a single room ventilation unit intended to ventilate a single room or enclosed space in a building, and not intended to be equipped with duct connections
central demand control means a demand control of a ducted ventilation unit that continuously regulates the fan speed(s) and flow rate based on one sensor for the whole ventilated building or part of the building at central level
local demand control means a demand control for a ventilation unit that continuously regulates the fan speed(s) and flow rates based on more than one sensor for a ducted ventilation unit or one sensor for a non-ducted unit
static pressure (psf) means the total pressure minus the fan dynamic pressure
total pressure (pf) means the difference between the stagnation pressure at the fan outlet and that at the fan inlet
stagnation pressure means the pressure measured at a point in a flowing gas if it were to be brought to rest by means of an isentropic process
dynamic pressure means the pressure calculated from the mass flow rate and the average gas density at the outlet and the unit outlet are
recuperative heat exchanger means a heat exchanger intended to transfer thermal energy from one air stream to another without moving parts, such as a plate or tubular heat exchanger with parallel flow, cross flow or counter flow, or a combination of these, or a plate or tubular heat exchanger with vapour diffusion
regenerative heat exchanger means a rotary heat exchanger incorporating a rotating wheel for the purpose of transferring thermal energy from one air stream to the other, including material allowing latent heat transfer, a drive mechanism, a casing or frame, and seals to reduce bypassing and leakage of air from one stream or another; such heat exchangers have varying degrees of moisture recovery depending on the material used
airflow sensitivity to pressure variations of a non-ducted RVU is the ratio between the maximum deviation from the maximum RVU flow rate at + 20 Pa and that at – 20 Pa external total pressure difference
indoor/outdoor air tightness of a non-ducted RVU is the flow rate (expressed in m3/h) between indoors and outdoors when the fan(s) is(are) switched off
dual use unit means a ventilation unit designed for ventilation purposes as well as fire or smoke extraction, complying with the basic requirements for construction works with regard to safety in case of fire as set out in Regulation (EU) No 305/2011
thermal by-pass facility means any solution that circumvents the heat exchanger or controls automatically or manually its heat recovery performance, without necessarily requiring a physical airflow bypass (for example: summer box, rotor speed control, control of air flow)
nominal electric power input (P) (expressed in kW) means the effective electric power input of the fan drives, including any motor control equipment, at the nominal external pressure and the nominal airflow
fan efficiency (ηfan) means the static efficiency including motor and drive efficiency of the individual fan(s) in the ventilation unit (reference configuration) determined at nominal air flow and nominal external pressure drop
eference configuration of a BVU means a product configured with a casing, at least two fans with variable speed or multi-speed drives, a HRS, a clean fine filter on the inlet-side and a clean medium filter on the exhaust-side
reference configuration of an UVU means a product configured with a casing and at least one fan with variable speed or multi-speed drive, and — in case the product is intended to be equipped with a filter on the inlet-side — this filter shall be a clean fine filter
minimum fan efficiency (ηνu) is the specific minimum efficiency requirement for VUs within the scope of this Regulation
nominal flow rate (qnom) (expressed in m3/s) means the declared design flow rate of an NRVU at standard air conditions 20 °C and 101 325 Pa, whereby the unit is installed complete (for example, including filters) and according to the manufacturer instructions
nominal external pressure (Δps, ext) in (expressed in Pa) means the declared design external static pressure difference at nominal flow rate
maximum rated fan speed (vfan_rated) (expressed in rounds per minute — rpm) is the fan speed at nominal flow rate and nominal external pressure
internal pressure drop of ventilation components (Δps,int) (expressed in Pa) means the sum of the static pressure drops of a reference configuration of a BVU or an UVU at nominal flow rate
internal pressure drop of additional non-ventilation components (Δps,add) (expressed in Pa) means the remainder of the sum of all internal static pressure drops at nominal flow rate and nominal external pressure after subtraction of the internal pressure drop of ventilation components (Δps,int )
thermal efficiency of a non-residential HRS (ηt_nrvu) means the ratio between supply air temperature gain and the exhaust air temperature loss, both relative to the outdoor temperature, measured under dry reference conditions, with balanced mass flow, an indoor-outdoor air temperature difference of 20 K, excluding thermal heat gain from fan motors and from internal leakages
nternal specific fan power of ventilation components (SFPint) (expressed in W/(m3/s)) is the ratio between the internal pressure drop of ventilation components and the fan efficiency, determined for the reference configuration
maximum internal specific fan power of ventilation components (SFPint_limit) (expressed in W/(m3/s)) is the specific efficiency requirement for SFPint for VUs within the scope of this Regulation
run-around HRS is a heat recovery system where the heat recovery device on the exhaust side and the device supplying the recovered heat to the air stream on the supply side of a ventilated space are connected through a heat transfer system where the two sides of the HRS can be freely positioned in different parts of a building
face velocity (expressed in m/s) is the larger of supply and extract air velocity. The velocities are the air velocities in the VU based on the inside unit area for supply respectively extract air flow of the VU. The velocity is based on the area of the filter section of the respective unit, or if no filter is installed, based on the area of the fan section
efficiency bonus (E) is a correction factor taking account of the fact that more efficient heat recovery causes more pressure drops requiring more specific fan power
filter correction (F) (expressed in Pa) is a correction value to be applied if a unit deviates from the reference configuration of a BVU
fine filter means a filter that meets the relevant conditions described in Annex IX
medium filter means a filter that meets the relevant conditions described in Annex IX
filter efficiency means the average ratio between the dust fraction captured and the amount fed into the filter, under the conditions described for fine and medium filters in Annex IX
local space heater means a space heating device that emits heat by direct heat transfer or by direct heat transfer in combination with heat transfer to a fluid, in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated, possibly combined with a heat output to other spaces and is equipped with one or more heat generators that convert electricity or gaseous or liquid fuels directly into heat, through use of the Joule effect or combustion of fuels respectively
domestic local space heater means a local space heater other than a commercial one
gaseous fuel local space heater means an open fronted local space heater or a closed fronted local space heater using gaseous fuel
liquid fuel local space heater means an open fronted local space heater or a closed fronted local space heater using liquid fue
electric local space heater means a local space heater using the electric Joule effect to generate heat
commercial local space heater means either a luminous local space heater or tube local space heate
open fronted local space heater means a local space heater, using gaseous or liquid fuels, of which the fire bed and combustion gases are not sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
closed fronted local space heater means a local space heater, using gaseous or liquid fuels, of which the fire bed and combustion gases are sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
electric portable local space heater means an electric local space heater which is not an electric fixed local space heater, electric storage local space heater, electric underfloor local space heater, electric radiant local space heater, electric visibly glowing local space heater or slave heater
electric fixed local space heater means an electric local space heater not intended to accumulate thermal energy and designed to be used while fastened or secured in a specific location or wall mounted and not incorporated in the building structure or building finishing
electric storage local space heater means an electric local space heater designed to store heat in an accumulating isolated core and to discharge it for several hours after the accumulation phase
electric underfloor local space heater means an electric local space heater designed to be used while incorporated in the building structure or building finishing
electric radiant local space heater means an electric local space heater in which the heat emitting element is to be directed towards the place of use so that its thermal radiation directly warms the subjects to be heated and which has a temperature rise of the grill covering the heat emitting element of at least 130 °C in normal use and/or a temperature rise of 100 °C for other surfaces
electric visibly glowing radiant local space heater means an electric local space heater in which the heating element is visible from outside the heater and has a temperature of at least 650 °C in normal use
sauna stove means a space heating product, incorporated in, or declared to be used in, dry or wet sauna's or similar environments
slave heater means an electric local space heater which is not capable of autonomous operation and needs to receive signals sent from an external master controller, not being part of the product but connected to it by pilot wire, wireless, power line communication or an equivalent technique, in order to regulate the emission of heat into the room in which the product is installed
luminous local space heater means a local space heater, using gaseous or liquid fuel which is equipped with a burner; which is to be installed above head level, directed towards the place of use so that the heat emission of the burner, being predominantly infrared radiation, directly warms the subjects to be heated and which emits the products of combustion in the space where it is situated
tube local space heater means a local space heater, using gaseous or liquid fuel, which is equipped with a burner; which is to be installed above head level, near the subjects to be heated, which heats the space primarily by infrared radiation from the tube or tubes heated by the internal passage of products of combustion and of which the products of combustion are to be evacuated through a flue duct
tube heater system means a tube local space heater comprising more than one single burner, of which the products of combustion of one burner may feed into a next burner, and of which the products of combustion of multiple burners are to be evacuated by a single exhaust fan
tube heater segment means a part of a tube heater system that comprises all the elements needed for standalone operation and as such can be tested independently of the other tube heating system parts
flueless heater means a local space heater using gaseous or liquid fuel emitting the products of combustion into the space where the product is situated, other than a luminous local space heater
open to chimney heater means a local space heater using gaseous or liquid fuels intended to sit under a chimney or in a fireplace without sealing between the product and the chimney or fireplace opening, and allowing the products of combustion pass unrestricted from the fire bed to the chimney or flue
air heating product means a product providing heat to an air-based heating system only that can be ducted and is designed to be used while fastened or secured in a specific location or wall mounted which distributes the air by means of an air moving device in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated
direct heat output means the heat output of the product by radiation and convection of heat, as emitted by or from the product itself to air, excluding the heat output of the product to a heat transfer fluid, expressed in kW
indirect heat output means the heat output of the product to a heat transfer fluid by the same heat generation process that provides the direct heat output of the product, expressed in kW
indirect heating functionality means the product is capable of transferring part of the total heat output to a heat transfer fluid, for use as space heating or domestic hot water generation
nominal heat output (Pnom) means the heat output of a local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the maximum heat output that can be maintained over an extended period, as declared by the manufacturer, expressed in kW
minimum heat output (Pmin) means the heat output of a local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the lowest heat output, as declared by the manufacturer, expressed in kW
maximum continuous heat output (Pmax,c) means the declared heat output of an electric local space heater when operating at the setting for the maximum heat output that can be maintained continuously over an extended period, as declared by the manufacturer, expressed in kW
intended for outdoor use means the product is suitable for safe operation outside enclosed spaces, including possible use in outdoor conditions
equivalent model means a model placed on the market with the same technical parameters set out in Table 1, Table 2 or Table 3 of point 3 of Annex II as another model placed on the market by the same manufacturer
seasonal space heating energy efficiency (ηs) means the ratio between the space heating demand, supplied by a local space heater and the annual energy consumption required to meet this demand, expressed in %
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient is CC = 2,5
nitrogen oxides emissions means the emissions of nitrogen oxides at nominal heat output expressed in mg/kWhinput based on GCV for gaseous or liquid fuel local space heaters and commercial local space heaters
net calorific value (NCV) means the total amount of heat released by a unit quantity of fuel containing the appropriate moisture of the fuel, when it is burned completely with oxygen, and when the products of combustion are not returned to ambient temperature
gross calorific value moisture free (GCV) means the total amount of heat released by a unit quantity of fuel dried of inherent moisture, when it is burned completely with oxygen, and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of the water vapour formed by the combustion of any hydrogen contained in the fuel
useful efficiency, at either nominal or minimum heat output (ηth,nom or ηth,min respectively) means the ratio of the useful heat output and the total energy input of a local space heater, expressed in %, whereby:
(a) for domestic local space heaters the total energy input is expressed in terms of NCV and/or in terms of final energy multiplied by CC;
(b) for commercial local space heaters the total energy input is expressed in terms of GCV and in terms of final energy multiplied by CC
electric power requirement at nominal heat output (elmax) means the electric power consumption of the local space heater while providing the nominal heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement at minimum heat output’ (elmin) means the electric power consumption of the local space heater while providing the minimum heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement in standby mode (elsb) means the electric power consumption of the product while in standby mode, expressed in kW
permanent pilot flame power requirement (Ppilot) means the fuel consumption of gaseous or liquid fuel of the product for the provision of a flame to serve as an ignition source for the more powerful combustion process needed for nominal or part load heat output, when lit for more than 5 minutes before the main burner is on, expressed in kW
manual heat charge control, with integrated thermostat means a manually operated sensing device integrated into the product, which measures and regulates its core temperature to vary the accumulated amount of heat;
manual heat charge control with room and/or outdoor temperature feedback means a manually operated sensing device integrated into the product which measures its core temperature and varies the accumulated amount of heat in relation with the room temperature and/or outdoor temperature
electronic heat charge control with room and/or external temperature feedback or regulated by energy supplier means an automatically operated sensing device integrated into the product which measures its core temperature and varies the accumulated amount of heat in relation with the room temperature and/or outdoor temperature or a device whose charging regime can be regulated by the energy supplier
fan assisted heat output means the product is equipped with an integrated and controllable fan (or fans) to vary the heat output to adjust to the heat deman
single stage heat output, no room temperature control means the product is not capable of varying its heat output automatically and that no feedback of room temperature is present to adapt the heat output automatically
two or more manual stages, no room temperature control means the product is capable of varying its heat output manually by two or more levels of heat output and is not equipped with a device that automatically regulates the heat output in relation to a desired indoor temperature
with mechanic thermostat room temperature control means the product is equipped with a non-electronic device that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control plus day timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature level for a 24-hours timer interval
with electronic room temperature control plus week timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature levels for a full week. During the 7-day period the settings must allow a variation on a day-to-day basis
room temperature control, with presence detection means the product is equipped with an electronic device, either integrated or external, that automatically reduces the set-point for the room temperature when no person is detected in the room
room temperature control, with open window detection means the product is equipped with an electronic device, either integrated or external, that reduces the heat output when a window or door has been opened. Whenever a sensor is used to detect the opening of a window or door, it can be installed with the product, externally to the product, built into the building structure or as a combination of those options
with distance control option means the function that allows remote interaction from outside the building in which the product is installed with the control of the product
with adaptive start control means the function which predicts and initiates the optimal start of heating up in order to reach the set-point temperature at the desired time
with working time limitation means the product has a function that automatically deactivates the product after a pre-set period of time
with black bulb sensor means the product is equipped with an electronic device, either integrated or external, that measures air and radiant temperature
single stage means that the product is not capable of automatically varying its heat output
two stage means the product is capable of automatically regulating its heat output in two distinct levels, in relation to the actual indoor air temperature and a desired indoor air temperature, controlled through temperature sensing devices and an interface which is not necessarily integral to the product itself
modulating means the product is capable of automatically regulating its heat output in three or more distinct levels, in relation to the actual indoor air temperature and a desired indoor air temperature, controlled through temperature sensing devices and an interface which is not necessarily integral to the product itself
standby mode means a condition where the product is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
tube system heat output’ means the combined tube segment heat output of the configuration as it is placed on the market, expressed in kW
tube segment heat output means the heat output of a tube segment which together with other tube segments forms part of a configuration of a tube system, expressed in kW
radiant factor, at either nominal or minimum heat output (RFnom or RFmin respectively) means the ratio of the infrared heat output of the product compared to the total energy input when providing the nominal or minimum heat output, calculated as infrared energy output divided by total energy input on the basis of the net calorific value (NCV) of the fuel when providing the nominal or minimum heat output, expressed in %
envelope insulation means the level of thermal insulation of the product envelope or jacket as applied to minimise heat losses if the product is allowed to be placed outdoors
envelope loss factor means the thermal losses by that part of the product that is installed outside the enclosed space to be heated and which is determined by the transmittance of the relevant envelope of that part, expressed in %
model identifier means the code, usually alphanumeric, which distinguishes a specific local space heater model from other models with the same trade mark or manufacturer's name
moisture content moisture content
professional refrigerated storage cabinet means an insulated refrigerating appliance integrating one or more compartments accessible via one or more doors or drawers, capable of continuously maintaining the temperature of foodstuffs within prescribed limits at chilled or frozen operating temperature, using a vapour compression cycle, and intended for the storage of foodstuffs in non-household environments but not for the display to or access by customers
blast cabinet means an insulated refrigerating appliance primarily intended to rapidly cool hot foodstuffs to below 10 °C in the case of chilling and below – 18 °C in the case of freezing
blast room means an enclosure, for which the doorway and internal space is large enough for a person to step inside, primarily intended to rapidly cool hot foodstuffs to below 10 °C in the case of chilling and below – 18 °C in the case of freezing
capacity means, for blast cabinets, the food weight which can be processed (by the blast cabinet) to below 10 °C in the case of chilling and below – 18 °C in the case of freezing in a single operation
continuous process blast equipment means a blast cabinet provided with a conveyor belt to feed foodstuff through, to allow continuous process for blast chilling or freezing of the foodstuff
foodstuffs means food, ingredients, beverages, including wine, and other items primarily intended for consumption which require refrigeration at specified temperatures
built-in cabinet means a fixed insulated refrigerating appliance intended to be installed in a cabinet, in a prepared recess in a wall or similar location, and requiring furniture finishing
roll-in cabinet means a professional refrigerated storage cabinet including one unique compartment that allows wheeled racks of product to be wheeled in
pass-through cabinet means a professional refrigerated storage cabinet accessible from both sides
static air cabinet means a professional refrigerated storage cabinet without internal forced-air circulation, specifically designed to store temperature-sensitive foodstuffs or to avoid a drying effect on foodstuffs stored without a sealed enclosure, where a single static air compartment within the cabinet is not sufficient to designate the cabinet as a static air cabinet
heavy-duty cabinet means a professional refrigerated storage cabinet capable of continuously maintaining chilled or frozen operating temperature in all its compartment(s) in ambient conditions corresponding to climate class 5, as detailed in Table 3 of Annex IV
open cabinet means a professional refrigerated storage cabinet whose refrigerated enclosure can be reached from the outside without opening a door or a drawer, where the mere presence of one compartment which can be reached from the outside without opening a door or a drawer, with a net volume equivalent to less than 20 % of the professional refrigerated storage cabinet's total volume, is not sufficient to qualify it as such
saladette means a professional refrigerated storage cabinet with one or more doors or drawer fronts in the vertical plane that has cut-outs in the top surface into which temporary storage bins can be inserted for easy-access storage of foodstuffs such as, but not limited to, pizza toppings or salad items
chest freezer means a food freezer in which the compartment(s) is accessible from the top of the appliance or which has both top-opening type and upright type compartments but where the gross volume of the top-opening type compartment(s) exceeds 75 % of the total gross volume of the appliance
condensing unit means a product integrating at least one electrically driven compressor and one condenser, capable of cooling down and continuously maintaining low or medium temperature inside a refrigerated appliance or system, using a vapour compression cycle once connected to an evaporator and an expansion device
low temperature means that the condensing unit is capable of delivering its rated cooling capacity at a saturated evaporating temperature of – 35 °C
medium temperature means that the condensing unit is capable of delivering its rated cooling capacity at a saturated evaporating temperature of – 10 °C
rated cooling capacity means the cooling capacity which the condensing unit allows the vapour compression cycle to reach, once connected to an evaporator and an expansion device, when operating at full load, and measured at standard rating conditions with the reference ambient temperature set at 32 °C, expressed in kW
process chiller means a product integrating at least one compressor and one evaporator, capable of cooling down and continuously maintaining the temperature of a liquid in order to provide cooling to a refrigerated appliance or system; it may or may not integrate the condenser, the coolant circuit hardware and other ancillary equipment
low temperature means that the process chiller is capable of delivering its rated cooling capacity at an indoor heat exchanger outlet temperature of – 25 °C, at standard rating conditions
medium temperature means that the process chiller is capable of delivering its rated cooling capacity at an indoor heat exchanger outlet temperature of – 8 °C, at standard rating conditions
high temperature means that the process chiller is capable of delivering its rated cooling capacity at an indoor heat exchanger outlet temperature of 7 °C, at standard rating conditions
rated cooling capacity expressed in kW, means the cooling capacity that the process chiller is able to reach, when operating at full load, and measured at standard rating conditions with the reference ambient temperature at 35 °C for air-cooled chillers and 30 °C water inlet temperature at the condenser for water-cooled chillers
compressor pack or compressor rack means a product incorporating at least one or more electrically driven refrigeration compressor(s) and a control system
absorption chiller means a process chiller in which refrigeration is effected by an absorption process using heat as the energy source
evaporative condensing chiller means a process chiller equipped with an evaporating condenser, in which the refrigerant is cooled by a combination of air movement and water spray
net volume means the volume containing foodstuffs within the load limit
chilled operating temperature means that the temperature of foodstuffs stored in the cabinet is continuously maintained at a temperature between – 1 °C and 5 °C
frozen operating temperature means that the temperature of foodstuffs stored in the cabinet is continuously maintained at a temperature lower than – 15 °C, which is understood as the highest temperature of the warmest package test
multi-use cabinet means that a professional refrigerated storage cabinet or separate compartment of the same cabinet may be set at different temperatures for chilled or frozen foodstuffs
combined cabinet means a professional refrigerated storage cabinet including two or more compartments with different temperatures for the refrigeration and storage of foodstuffs
refrigerator-freezer means a type of combined cabinet including at least one compartment exclusively intended for chilled operating temperature and one compartment exclusively intended for frozen operating temperature
vertical cabinet means a professional refrigerated storage cabinet of overall height equal to or higher than 1 050 mm with one or more front doors or drawers accessing the same compartment
counter cabinet means a professional refrigerated storage cabinet of overall height lower than 1 050 mm with one or more front doors or drawers accessing the same compartment
light-duty cabinet also known as ‘semi-professional cabinet’, means a professional refrigerated storage cabinet only capable of continuously maintaining chilled or frozen operating temperature in all its compartment(s) in ambient conditions corresponding to climate class 3, as detailed in Table 3 of Annex IV; if the cabinet is able to maintain temperature in ambient conditions corresponding to climate class 4, it shall not be considered a light-duty cabinet
equivalent professional refrigerated storage cabinet means a professional refrigerated storage cabinet model placed on the market with the same net volume, same technical, efficiency and performance characteristics, and same compartment types and volumes as another professional refrigerated storage cabinet model placed on the market under a different commercial code number by the same manufacturer
equivalent blast cabinet means a blast cabinet model placed on the market with the same technical, efficiency and performance characteristics, as another blast cabinet model placed on the market under a different commercial code number by the same manufacturer
rated cooling capacity (PA) means the cooling capacity that the condensing unit enables the vapour compression cycle to reach, once connected to an evaporator and an expansion device, when operating at full load, and measured at standard rating conditions with the reference ambient temperature set at 32 °C, expressed in kW to two decimal places
rated power input (DA) means the electrical power input needed by the condensing unit (including the compressor, the condenser fan(s) and possible auxiliaries) to reach the rated cooling capacity, expressed in kW to two decimal places
rated coefficient of performance (COPA) means the rated cooling capacity, expressed in kW, divided by the rated power input, expressed in kW, expressed to two decimal places
coefficients of performance COPB, COPC and COPD mean the cooling capacity, expressed in kW, divided by the power input, expressed in kW, expressed to two decimal places at rating points B, C and D
seasonal energy performance ratio (SEPR) is the efficiency ratio of a condensing unit for providing cooling at standard rating conditions, representative of the variations in load and ambient temperature throughout the year, and calculated as the ratio between annual cooling demand and annual electricity consumption, expressed to two decimal places
annual cooling demand means the sum of each bin-specific cooling demand multiplied by the corresponding number of bin hours
bin-specific cooling demand means the cooling demand for every bin in the year, calculated as the rated cooling capacity multiplied by the part load ratio, expressed in kW to two decimal places
part load (Pc(Tj)) means the cooling load at a specific ambient temperature Tj, calculated as the full load multiplied by the part load ratio corresponding to the same ambient temperature Tj and expressed in kW at two decimal places
part load ratio (PR(Tj)) at a specific ambient temperature Tj means the ambient temperature Tj minus 5 °C divided by the reference ambient temperature minus 5 °C, and — for medium temperature — multiplied by 0,4 and added to 0,6, and — for low temperature — multiplied by 0,2 and added to 0,8. For ambient temperatures higher than the reference ambient temperature, the part load ratio shall be 1. For ambient temperatures lower than 5 °C, the part load ratio shall be 0,6 for medium temperature and 0,8 for low temperature. The part load ratio can be expressed at three decimal places or in percentage, after multiplying by 100, at one decimal place
annual electricity consumption is calculated as the sum of the ratios between each bin-specific cooling demand and the corresponding bin-specific coefficient of performance, multiplied by the corresponding number of bin hours
ambient temperature means the dry bulb air temperature, expressed in degrees Celsius
bin (binj) means a combination of an ambient temperature T j and bin hours h j , as set out in Table 6 of Annex VI
bin hours (hj) means the hours per year at which an ambient temperature occurs for each bin, as set out in Table 6 of Annex VI
reference ambient temperature means the ambient temperature, expressed in degrees Celsius, at which the part load ratio is equal to 1. It is set at 32 °C
bin-specific coefficient of performance (COPj) means the coefficient of performance for every bin in the year, derived from the part load, the declared cooling demand and declared coefficient of performance for specified bins, and calculated for other bins by linear interpolation, corrected where necessary by the degradation coefficient
declared cooling demand means the cooling demand at a limited number of specified bins, and calculated as the rated cooling capacity multiplied by the corresponding part load ratio
declared coefficient of performance means the coefficient of performance at a limited number of specified bins, and calculated as the declared cooling capacity divided by the declared power input
declared cooling capacity means the cooling capacity which the unit delivers to meet the specific cooling demand at a limited number of specified bins, expressed in kW to two decimal places
declared power input means the electrical power input needed by the condensing unit to meet the declared cooling capacity, expressed in kW to two decimal places
degradation coefficient (Cdc) is set at 0,25 and means the measure of efficiency loss due to the possible on/off cycling of condensing units necessary to satisfy the required part load in case the unit's capacity control cannot unload to the required part load
capacity control means the ability of a condensing unit to change its capacity by changing the volumetric flow rate of the refrigerant, to be indicated as ‘fixed’ if the unit cannot change its volumetric flow rate, ‘staged’ if the volumetric flow rate is changed or varied in series of not more than two steps, or ‘variable’ if the volumetric flow rate is changed or varied in series of three or more steps
rated cooling capacity (PA) expressed in kW to two decimal places, means the cooling capacity that the process chiller is able to reach, when operating at full load, and measured at standard rating conditions with the reference ambient temperature at 35 °C for air-cooled chillers and 30 °C water inlet temperature at the condenser for water-cooled chillers
rated power input (DA) means the electrical power input needed by the process chiller (including the compressor, the condenser fan(s) or pumps(s), the evaporator pump(s) and possible auxiliaries) to reach the rated cooling capacity, expressed in kW to two decimal places
rated energy efficiency ratio (EERA) means the rated cooling capacity, expressed in kW, divided by the rated power input, expressed in kW, expressed to two decimal places
seasonal energy performance ratio (SEPR) is the efficiency ratio of a process chiller for providing cooling at standard rating conditions, representative of variations in load and ambient temperature throughout the year, and calculated as the ratio between annual cooling demand and annual electricity consumption, expressed to two decimal places
annual cooling demand means the sum of each bin-specific cooling demand multiplied by the corresponding number of bin hours
bin-specific cooling demand means the rated cooling capacity multiplied by the part load ratio, for every bin in the year, expressed in kW to two decimal place
part load (Pc(Tj)) means the cooling load at a specific ambient temperature Tj, calculated as the full load multiplied by the part load ratio corresponding to the same ambient temperature Tj and expressed in kW at two decimal places
part load ratio’ (PR(Tj)) at a specific ambient temperature Tj means:
(a) for process chillers using an air-cooled condenser, the ambient temperature Tj minus 5 °C divided by the reference ambient temperature minus 5 °C, and multiplied by 0,2 and added to 0,8. For ambient temperatures higher than the reference ambient temperature, the part load ratio shall be 1. For ambient temperatures lower than 5 °C, the part load ratio shall be 0,8;
(b) for process chillers using a water-cooled condenser, the water inlet temperature Tj minus 9 °C divided by the reference water inlet temperature (30 °C) minus 9 °C, and multiplied by 0,2 and added to 0,8. For ambient temperatures higher than the reference ambient temperature, the part load ratio shall be 1. For ambient temperatures lower than 5 °C (9 °C water inlet temperature at the condenser), the part load ratio shall be 0,8;
The part load ratio can be expressed at three decimal places or in percentage, after multiplying by 100, at one decimal place
annual electricity consumption is calculated as the sum of the ratios between each bin-specific cooling demand and the corresponding bin-specific energy efficiency ratio, multiplied by the corresponding number of bin hours
ambient temperature means:
(a) for process chillers using an air-cooled condenser, the air dry bulb temperature, expressed in degrees Celsius
(b) for process chillers using a water-cooled condenser, the water inlet temperature at the condenser, expressed in degrees Celsius
bin (binj) means a combination of an ambient temperature T j and bin hours h j , as set out in Annex VIII
bin hours (hj) means the hours per year at which an ambient temperature occurs for each bin, as set out in Annex VIII
reference ambient temperature means the ambient temperature, expressed in degrees Celsius, at which the part load ratio is equal to 1. It shall be set at 35 °C. For air-cooled process chillers, the air inlet temperature to the condenser is then defined as 35 °C while for water-cooled process chillers the water inlet temperature to the condenser is defined as 30 °C
bin-specific energy efficiency ratio (EERj) means the energy efficiency ratio for every bin in the year, derived from the part load, the declared cooling demand and declared energy efficiency ratio for specified bins, and calculated for other bins by linear interpolation, corrected where necessary by the degradation coefficient
declared cooling demand means the cooling demand at a limited number of specified bins, and calculated as the rated cooling capacity multiplied by the corresponding part load ratio
declared energy efficiency ratio means the energy efficiency ratio at a limited number of specified bins
declared power input means the electrical power input needed by the process chiller to meet the declared cooling capacity
declared cooling capacity means the cooling capacity delivered by the chiller to meet the declared cooling demand
degradation coefficient (Cc) means the measure of efficiency loss due to cycling of process chillers at part load; if Cc is not determined by measurement, then the default degradation coefficient is Cc = 0,9
capacity control means the ability of a process chiller to change its capacity by changing the volumetric flow rate of the refrigerant, to be indicated as ‘fixed’ if the process chiller cannot change its volumetric flow rate, ‘staged’ if the volumetric flow rate is changed or varied in series of not more than two steps, or ‘variable’ if the volumetric flow rate is changed or varied in series of three or more steps
global warming potential (GWP) means the measure of how much 1 kg of the refrigerant applied in the vapour compression cycle is estimated to contribute to global warming, expressed in kg CO2 equivalents over a 100-year time horizon
flight plan means specified information provided to air traffic service units, relative to an intended flight or portion of a flight of an aircraft
pre-flight phase means the period from the first submission of a flight plan until the first delivery of an air traffic control clearance
repetitive flight plan means a flight plan related to a series of frequently recurring, regularly operated individual flights with identical basic features, submitted by an operator for retention and repetitive use by air traffic service units
operator means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation
air traffic services unit’ (hereinafter ATS unit) means a unit, civil or military, responsible for providing air traffic services
Integrated Initial Flight Plan Processing System (IFPS) means a system within the European Air Traffic Management Network through which a centralised flight planning processing and distribution service, dealing with the reception, validation and distribution of flight plans, is provided within the airspace covered by this Regulation
air traffic control clearance (ATC clearance) means an authorisation for an aircraft to proceed under conditions specified by an air traffic control unit
IFR means the symbol used to designate instrument flight rules
air traffic control unit (ATC unit) means variously area control centre, approach control unit or aerodrome control tower
key items of a flight plan means the following items of a flight plan:
(a) aircraft identification;
(b) departure aerodrome;
(c) estimated off-block date;
(d) estimated off-block time;
(e) destination aerodrome;
(f) route excluding terminal area procedures;
(g) cruising speed(s) and requested flight level(s);
(h) aircraft type and category of wake turbulence;
(i) flight rules and type of flight;
(j) aircraft equipment and its related capabilities
originator means a person or organisation submitting flight plans and any associated update messages to the IFPS, including pilots, operators and agents acting on their behalf and ATS units
‘initial flight plan means the flight plan initially submitted by the originator including changes, if any, initiated and accepted by pilots, operators, an ATS unit or the centralised service for flight planning processing and distribution of flight plans during the pre-flight phase
aircraft identification means a group of letters, figures or a combination thereof which is either identical to, or the coded equivalent of, the aircraft call sign to be used in air-ground communications, and which is used to identify the aircraft in ground-ground air traffic services communication
estimated off-block date means the estimated date on which the aircraft will commence movement associated with departure
estimated off-block time means the estimated time at which the aircraft will commence movement associated with departure
terminal area procedures means the standard instrument departures and the standard instrument arrivals as defined in the ICAO procedures for Air Navigation Services — Aircraft Operations (PANS-OPS, Doc 8168 — Volume 1 — fifth edition — 2006, incorporating all amendments up to No 7)
air heating product means a device that:
(a) incorporates or provides heat to an air-based heating system;
(b) is equipped with one or more heat generators; and
(c) may include an air-based heating system for supplying heated air directly into the heated space by means of an air-moving device.
A heat generator designed for an air heating product and an air heating product housing designed to be equipped with such a heat generator shall, together, be considered as an air heating product
air-based heating system means the components and/or equipment necessary for the supply of heated air, by means of an air-moving device, either through ducting or directly into the heated space, where the purpose of the system is to attain and maintain the desired indoor temperature of an enclosed space, such as a building or parts thereof, for the thermal comfort of human beings
heat generator means the part of an air heating product that generates useful heat using one or more of the following processes:
(a) the combustion of liquid or gaseous fuels;
(b) the Joule effect, taking place in the heating elements of an electric resistance heating system;
(c) by capturing heat from ambient air, ventilation exhaust air, water or ground heat source(s) and transferring this heat to the air-based heating system using a vapour compression cycle or a sorption cycle
cooling product means a device that:
(a) incorporates, or provides chilled air or water to, an air-based cooling system or water-based cooling system; and
(b) is equipped with one or more cold generator(s).
A cold generator designed for use in a cooling product and a cooling product housing designed to be equipped with such a cold generator shall, together, be considered as a cooling product
air-based cooling system means the components or equipment necessary for the supply of cooled air, by means of an air-moving device, either through ducting or directly into the cooled space, in order to attain and maintain the desired indoor temperature of an enclosed space, such as a building or parts thereof, for the thermal comfort of human beings
water-based cooling system means the components or equipment necessary for the distribution of chilled water and the transfer of heat from indoor spaces to chilled water, where the purpose of the system is to attain and maintain the desired indoor temperature of an enclosed space, such as a building or parts thereof, for the thermal comfort of human beings
cold generator means the part of a cooling product that generates a temperature difference allowing heat to be extracted from the heat source, the indoor space to be cooled, and transferred to a heat sink, such as ambient air, water or ground, using a vapour compression cycle or a sorption cycle
comfort chiller means a cooling product:
(a) whose indoor side heat exchanger (evaporator) extracts heat from a water-based cooling system (heat source), designed to operate at leaving chilled water temperatures greater than or equal to + 2 °C;
(b) that is equipped with a cold generator; and
(c) whose outdoor side heat exchanger (condenser) releases this heat to ambient air, water or ground heat sink(s)
fan coil unit means a device that provides forced circulation of indoor air, for the purpose of one or more of heating, cooling, dehumidification and filtering of indoor air, for the thermal comfort of human beings, but which does not include the source of heating or cooling nor an outdoor side heat exchanger. The device may be equipped with minimal ductwork to guide the intake and exit of air, including conditioned air. The product may be designed to be built in or may have an enclosure allowing it be placed in the space to be conditioned. It may include a Joule effect heat generator designed to be used as back-up heater only
high temperature process chiller means a product:
(a) integrating at least one compressor, driven or intended to be driven by an electric motor, and at least one evaporator;
(b) capable of cooling down and continuously maintaining the temperature of a liquid, in order to provide cooling to a refrigerated appliance or system, the purpose of which is not to provide cooling of a space for the thermal comfort of human beings;
(c) that is capable of delivering its rated refrigeration capacity, at an indoor side heat exchanger outlet temperature of 7 °C, at standard rating conditions;
(d) that may or may not integrate the condenser, the coolant circuit hardware or other ancillary equipment
rated refrigeration capacity (P) means the refrigeration capacity that the high temperature process chiller is able to reach, when operating at full load and measured at an inlet air temperature of 35 °C for air-cooled high temperature process chillers and at an inlet water temperature of 30 °C for water-cooled high temperature process chillers, expressed in kW
air-cooled high temperature process chiller means a high temperature process chiller, of which the heat transfer medium at the condensing side is air
water-cooled high temperature process chiller means a high temperature process chiller, of which the heat transfer medium at the condensing side is water or brine
biomass fuel means a fuel produced from biomass
biomass means the biodegradable part of products, waste and residues of biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, and the biodegradable fraction of industrial and municipal waste
solid fuel means a fuel which is solid at normal indoor room temperatures
rated heating capacity (Prated,h) means the heating capacity of a heat pump, warm air heater or fan coil units when providing space heating at ‘standard rating conditions’, expressed in kW
rated cooling capacity (Prated,c) means the cooling capacity of a comfort chiller and/or air conditioner or fan coil units when providing space cooling at ‘standard rating conditions’, expressed in kW
standard rating conditions means the operating conditions of comfort chillers, air conditioners and heat pumps under which they are tested to determine their rated heating capacity, rated cooling capacity, sound power level and/or emissions of nitrogen oxides. For products using internal combustion engines, this is the engine rpm equivalent (Erpmequivalent)
leaving chilled water temperature means the temperature of the water leaving the comfort chiller, expressed in degree Celsius
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency, as established in Annex IV of Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient shall be CC = 2,5
gross calorific value (GCV) means the total amount of heat released by a unit quantity of fuel when it is burned completely with oxygen and when the products of combustion are returned to ambient temperature; this quantity includes the heat of condensation of any water vapour contained in the fuel and of the water vapour formed by the combustion of any hydrogen contained in the fuel
global warming potential (GWP) means the climatic warming potential of a greenhouse gas relative to that of carbon dioxide (CO2), calculated in terms of the 100-year warming potential of one kilogram of a greenhouse gas related to one kilogram of CO2. GWP values considered are those set out in Annexes I, II and IV to Regulation (EU) No 517/2014. GWP values for mixtures of refrigerants shall be based on the method presented in Annex IV of the Regulation (EU) No 517/2014
air flow rate means the air flow rate in m3/h measured at the air outlet of indoor and/or outdoor units (if applicable) of comfort chillers, air conditioners or heat pumps, and fan coil units at standard rating conditions for cooling, or heating if the product has no cooling function
sound power level (LWA) means the A-weighted sound power level measured indoors and/or outdoors, at standard rating conditions, and expressed in dB
supplementary heater means a heat generator of the air heating product that generates supplemental heat during conditions where the heating load exceeds the heating capacity of the preferred heat generator
preferred heat generator means the heat generator of the air heating product that has the highest contribution in the total heat supplied over the heating season
seasonal space heating energy efficiency (ηs,h) means the ratio between the reference annual heating demand pertaining to the heating season covered by an air heating product, and the annual energy consumption for heating, corrected by contributions accounting for temperature control and the electricity consumption of ground water pump(s), where applicable, expressed in %
seasonal space cooling energy efficiency (ηs,c) means the ratio between the reference annual cooling demand pertaining to the cooling season covered by a cooling product, and the annual energy consumption for cooling, corrected by contributions accounting for temperature control and the electricity consumption of ground water pump(s), where applicable, expressed in %
temperature control means equipment that interfaces with the end-user regarding the values and timing of desired indoor temperature and communicates relevant data, such as actual indoor and/or outdoor temperature(s), to an interface of the air heating or cooling product such as a central processing unit, thus contributing to the regulation of the indoor temperature(s)
bin (binj) means a combination of an ‘outdoor temperature (Tj )’ and ‘bin hours (h j)’, as set out in Annex III, Tables 26, 27 and 28
bin hours (hj) means the hours per season, expressed in hours per year, at which an outdoor temperature occurs for each bin, as set out in Annex III, Tables 26, 27 and 28
indoor temperature (Tin) means the dry bulb indoor air temperature, expressed in degrees Celsius; the relative humidity may be indicated by a corresponding wet bulb temperature
outdoor temperature (Tj) means the dry bulb outdoor air temperature, expressed in degrees Celsius; the relative humidity may be indicated by a corresponding wet bulb temperature
capacity control means the ability of a heat pump, air conditioner, comfort chiller or high temperature process chiller to change its heating or cooling capacity by changing the volumetric flow rate of the refrigerant(s), to be indicated as ‘fixed’ if the volumetric flow rate cannot be changed, ‘staged’ if the volumetric flow rate is changed or varied in series of not more than two steps, or ‘variable’ if the volumetric flow rate is changed or varied in series of three or more steps
degradation coefficient ((Cdh) for heating mode and (Cdc) for cooling or refrigeration mode) means the measure of efficiency loss due to cycling of the product; if it is not determined by measurement then the default degradation coefficient shall be 0,25 for an air conditioner or heat pump, or 0,9 for a comfort or high temperature process chiller
nitrogen oxides emissions means the sum of the emissions of nitrogen monoxide and nitrogen dioxide by air heating products or cooling products using gaseous or liquid fuels, and expressed in nitrogen dioxide, established while providing the rated heating capacity, expressed in mg/kWh in terms of GCV
warm air heater means an air heating product that transfers the heat from a heat generator directly to air and incorporates or distributes this heat through an air-based heating system
warm air heater using gaseous/liquid fuels means a warm air heater that uses a heat generator using the combustion of gaseous or liquid fuels
warm air heater using electricity means a warm air heater that uses a heat generator using the Joule effect in resistance heating
B1 warm air heater means a warm air heater using gaseous/liquid fuels specifically designed to be connected to a natural draught flue that evacuates the residues of combustion to the outside of the room containing the B1 warm air heater and for drawing the combustion air directly from the room; a type B1 warm air heater is marketed as a B1 warm air heater only
C2 warm air heater means a warm air heater using gaseous/liquid fuels specifically designed for drawing the combustion air from a common duct system to which more than one appliance is connected and extracting flue gas to the duct system; a type C2 warm air heater is marketed as a C2 warm air heater only
C4 warm air heater means a warm air heater using gaseous/liquid fuels specifically designed for drawing the combustion air from a common duct system to which more than one appliance is connected and extracting flue gas to another pipe of the flue system; a type C4 warm air heater is marketed as a C4 warm air heater only
minimum capacity means the minimum heating capacity of the warm air heater (Pmin), expressed in kW
useful efficiency at rated heating capacity (ηnom) means the ratio of the rated heating capacity and the total power input to achieve this heating capacity, expressed in %, whereby the total power input is based on the GCV of the fuel if using gaseous/liquid fuels
useful efficiency at minimum capacity (ηpl ) means the ratio of the minimum capacity and the total power input to achieve this heating capacity, expressed in %, whereby the total power input is based on the GCV of the fuel
seasonal space heating energy efficiency in active mode (ηs,on) means the seasonal thermal energy efficiency multiplied by the emission efficiency, expressed in %
seasonal thermal energy efficiency (ηs,th ) means the weighted average of the useful efficiency at rated heating capacity, and the useful efficiency at minimum capacity, including consideration of the envelope losses
emission efficiency (ηs,flow) means a correction applied in the calculation of the seasonal space heating energy efficiency in active mode that takes into account the equivalent air flow of the heated air and the heating capacity
envelope loss factor (Fenv) means the losses in seasonal space heating energy efficiency due to heat loss of the heat generator to areas outside the space to be heated, expressed in %
auxiliary electricity consumption means the losses in seasonal space heating energy efficiency due to electric power consumption at rated heating capacity (elmax ), at minimum capacity (elmin ) and in standby mode (elsb ), expressed in %
pilot flame losses means the losses in seasonal space heating energy efficiency caused by the ignition burner power consumption, expressed in %
permanent pilot flame power consumption (Pign ) means the power consumption of a burner intended to ignite the main burner and that can only be extinguished by intervention of the user, expressed in W based on the GCV of the fuel
vented flue losses means the losses in seasonal space heating energy efficiency during periods the preferred generator is not active, expressed in %
heat pump means an air heating product:
(a) of which the outdoor side heat exchanger (evaporator) extracts heat from ambient air, ventilation exhaust air, water, or ground heat sources;
(b) which has a heat generator that uses a vapour compression cycle or a sorption cycle;
(c) of which the indoor side heat exchanger (condenser) releases this heat to an air-based heating system;
(d) which may be equipped with a supplementary heater;
(e) which may operate in reverse in which case it functions as an air conditioner
air-to-air heat pump means a heat pump which has a heat generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (evaporator) allows heat transfer from ambient air
water/brine-to-air heat pump means a heat pump which has a heat generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (evaporator) allows heat transfer from water or brine
rooftop heat pump means an air-to-air heat pump, driven by an electric compressor, of which the evaporator, compressor and condenser are integrated into a single package
sorption cycle heat pump means a heat pump which has a heat generator that uses a sorption cycle relying on external combustion of fuels and/or supply of heat
multi-split heat pump means a heat pump incorporating more than one indoor units, one or more refrigerating circuit, one or more compressors and one or more outdoor units, where the indoor units may or may not be individually controlled
air conditioner means a cooling product that provides space cooling and:
(a) of which the indoor side heat exchanger (evaporator) extracts heat from an air-based cooling system (heat source);
(b) which has a cold generator that uses a vapour compression cycle or a sorption cycle;
(c) of which the outdoor side heat exchanger (condenser) releases this heat to ambient air, water or ground heat sink(s) and which may or may not include heat transfer that is based on evaporation of externally added water;
(d) may operate in reverse in which case it functions as a heat pump
air-to-air air conditioner means an air conditioner which has a cold generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (condenser) allows heat transfer to air
water/brine-to-air air conditioner means an air conditioner which has a cold generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (condenser) allows heat transfer to water or brine
rooftop air conditioner means an air-to-air air conditioner, driven by an electric compressor, of which the evaporator, compressor and condenser are integrated into a single package
multi-split air conditioner means an air conditioner incorporating more than one indoor units, one or more refrigeration circuits, one or more compressors and one or more outdoor units, where the indoor units may or may not be individually controlled
sorption cycle air conditioner means an air conditioner which has a cold generator that uses a sorption cycle relying on external combustion of fuels and/or supply of heat
air-to-water comfort chiller means a comfort chiller that has a cold generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (condenser) allows heat transfer to air, including heat transfer that is based on evaporation into this air of externally added water, provided that the device is also able to function without the use of additional water, using air only
water/brine-to-water comfort chiller means a comfort chiller that has a cold generator that uses a vapour compression cycle driven by an electric motor or internal combustion engine and whereby the outdoor side heat exchanger (condenser) allows heat transfer to water or brine, excluding heat transfer that is based on evaporation of externally added water
sorption cycle comfort chiller means a comfort chiller which has a cold generator that uses a sorption cycle relying on external combustion of fuels and/or supply of heat
reference design conditions means the combination of the ‘reference design temperature’, the maximum ‘bivalent temperature’ and the maximum ‘operation limit temperature’, as set out in Annex III, Table 24
reference design temperature means the ‘outdoor temperature’ for either cooling (Tdesign,c) or heating (Tdesign,h) as described in Annex III, Table 24, at which the ‘part load ratio’ is equal to 1 and which varies according to the cooling or heating season, expressed in degrees Celsius
bivalent temperature (Tbiv) means the outdoor temperature (Tj ) declared by the manufacturer at which the declared heating capacity equals the part load for heating and below which the declared heating capacity has to be supplemented with electric back-up heater capacity in order to meet the part load for heating, expressed in degrees Celsius
operation limit temperature (Tol) means the outdoor temperature declared by the manufacturer for heating, below which the heat pump will not be able to deliver any heating capacity and the declared heating capacity is equal to zero, expressed in degrees Celsius
part load ratio (pl(Tj)) means the ‘outdoor temperature’ minus 16 °C, divided by the ‘reference design temperature’ minus 16 °C, for either space cooling or space heating
season means a set of ambient conditions, designated as either a heating season or a cooling season, describing per bin the combination of outdoor temperatures and bin hours pertaining to that season
part load for heating (Ph(Tj)) means the heating load at a specific outdoor temperature, calculated as the design heating load multiplied by the part load ratio and expressed in kW
part load for cooling (Pc(Tj)) means the cooling load at a specific outdoor temperature, calculated as the design cooling load multiplied by the part load ratio and expressed in kW
seasonal energy efficiency ratio (SEER) is the overall energy efficiency ratio of the air conditioner or comfort chiller, representative for the cooling season, calculated as the ‘reference annual cooling demand’ divided by the ‘annual energy consumption for cooling’
seasonal coefficient of performance (SCOP) is the overall coefficient of performance of a heat pump using electricity, representative of the heating season, calculated as the reference annual heating demand divided by the ‘annual energy consumption for heating’
reference annual cooling demand (QC) means the reference cooling demand to be used as basis for calculation of SEER and calculated as the product of the design cooling load (Pdesign,c ) and the equivalent active mode hours for cooling (HCE), expressed in kWh
reference annual heating demand (QH) means the reference heating demand, and pertaining to a designated heating season, to be used as basis for calculation of SCOP and calculated as the product of the design heating load (Pdesign,h) and the equivalent active mode hours for heating (HHE), expressed in kWh
annual energy consumption for cooling (QCE) means the energy consumption required to meet the ‘reference annual cooling demand’ and is calculated as the ‘reference annual cooling demand’ divided by the ‘active mode seasonal energy efficiency ratio’ (SEERon) and the electricity consumption of the unit for thermostat-off, standby, off and crankcase heater mode during the cooling season, expressed in kWh
annual energy consumption for heating (QHE) means the energy consumption required to meet the ‘reference annual heating demand’ pertaining to a designated heating season, and is calculated as the ‘reference annual heating demand’ divided by the ‘active mode seasonal coefficient of performance’ (SCOPon ) and the electricity consumption of the unit for thermostat-off, standby, off and crankcase heater mode during the heating season expressed in kWh
equivalent active mode hours for cooling (HCE) means the assumed annual number of hours the unit must provide the ‘design cooling load’ (Pdesign,c ) in order to satisfy the ‘reference annual cooling demand’, expressed in hours
equivalent active mode hours for heating (HHE) means the assumed annual number of hours a heat pump air heater has to provide the design heating load to satisfy the reference annual heating demand, expressed in hours
active mode seasonal energy efficiency ratio (SEERon) means the average energy efficiency ratio of the unit in active mode for the cooling function, constructed from part load and bin-specific energy efficiency ratios (EERbin (Tj)) and weighted by the bin hours the bin condition occurs
active mode seasonal coefficient of performance (SCOPon) means the average coefficient of performance of the heat pump in active mode, for the heating season, constructed from the part load, electric back up heating capacity (where required) and bin-specific coefficients of performance (COPbin (Tj)) and weighted by the bin hours the bin condition occurs
bin-specific coefficient of performance (COPbin (Tj)) means the coefficient of performance of the heat pump for every binj with outdoor temperature (Tj) in a season, derived from the part load, declared capacity and declared coefficient of performance (COPd (Tj) and calculated for other bins through inter/extrapolation, when necessary corrected by the applicable degradation coefficient
bin-specific energy efficiency ratio (EERbin (Tj)) means the energy efficiency ratio specific for every binj with outdoor temperature (Tj) in a season, derived from the part load, declared capacity and declared energy efficiency ratio (EERd (Tj)) and calculated for other bins through inter/extrapolation, when necessary corrected by the applicable degradation coefficient
declared heating capacity (Pdh(Tj)) means the heating capacity of the vapour compression cycle of a heat pump, pertaining to an outdoor temperature (Tj) and indoor temperature (Tin), as declared by the manufacturer, expressed in kW
declared cooling capacity (Pdc(Tj)) means the cooling capacity of the vapour compression cycle of the air conditioner or comfort chiller, pertaining to an outdoor temperature (Tj) and indoor temperature (Tin), as declared by the manufacturer, expressed in kW
design heating load (Pdesign,h) means the heating load applied to a heat pump at the reference design temperature, whereby the design heating load (Pdesign,h) is equal to the part load for heating with outdoor temperature (Tj) equal to reference design temperature for heating (Tdesign,h), expressed in kW
design cooling load (Pdesign,c) means the cooling load applied to a comfort chiller or air conditioner at the reference design conditions, whereby the design cooling load (Pdesign,c) is equal to declared cooling capacity at outdoor temperature (Tj) equal to reference design temperature for cooling (Tdesign,c), expressed in kW
declared coefficient of performance (COPd (Tj)) means the coefficient of performance at a limited number of specified bins (j) with outdoor temperature (Tj)
declared energy efficiency ratio (EERd (Tj) means the energy efficiency ratio at a limited number of specified bins (j) with outdoor temperature (Tj)
electric back-up heating capacity (elbu(Tj)) is the heating capacity of a real or assumed supplementary heater with a COP of 1 that supplements the declared heating capacity (Pdh(Tj)) in order to meet the part load for heating (Ph(Tj)) in case Pdh(Tj) is less than Ph(Tj), for the outdoor temperature (Tj), expressed in kW
capacity ratio means the part load for heating (Ph (Tj)) divided by the declared heating capacity (Pdh (Tj)) or the part load for cooling (Pc (Tj)) divided by the declared cooling capacity (Pdc (Tj))
active mode means the mode corresponding to the hours with a cooling or heating load of the building and whereby the cooling or heating function of the unit is activated. This condition may involve on/off-cycling of the unit in order to reach or maintain a required indoor air temperature
standby mode means a condition where the warm air heater, comfort chiller, air conditioner or heat pump is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
reactivation function means a function facilitating the activation of other modes, including active mode, by remote switch including remote control via network, internal sensor, timer to a condition providing additional functions, including the main function
reactivation function is a continuous function providing information or indicating the status of the equipment on a display, including clocks
off mode means a condition in which the comfort chiller, air conditioner or heat pump is connected to the mains power source and is not providing any function. Also considered as ‘off mode’ are conditions providing only an indication of ‘off mode’ condition, as well as conditions providing only functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2004/108/EC of the European Parliament and of the Council
thermostat-off mode means the condition corresponding to the hours with no cooling or heating load, whereby the cooling or heating function is switched on but the unit is not operational; cycling in active mode is not considered as thermostat-off mode
crankcase heater mode means the condition in which the unit has activated a heating device to avoid the refrigerant migrating to the compressor to limit the refrigerant concentration in oil at compressor start
off mode power consumption’ (POFF) means the power consumption of unit in off mode, expressed in kW
thermostat-off mode power consumption (PTO) means the power consumption of the unit while in thermostat-off mode, expressed in kW
standby mode power consumption (PSB) means the power consumption of the unit while in standby mode, expressed in kW
crankcase heater mode power consumption (PCK) means the power consumption of the unit while in crankcase heater mode, expressed in kW
off mode operating hours (HOFF) means the annual number of hours [hrs/a] the unit is considered to be in off-mode, the value of which depends on the designated season and function
thermostat-off mode operating hours (HTO) means the annual number of hours (hrs/a) the unit is considered to be in thermostat-off mode, the value of which depends on the designated season and function
standby mode operating hours (HSB) means the annual number of hours [hrs/a] the unit is considered to be in standby mode, the value of which depends on the designated season and function
crankcase heater mode operating hours (HCK) means the annual number of hours (hrs/a) the unit is considered to be in crankcase heater operation mode, the value of which depends on the designated season and function
seasonal primary energy ratio in cooling mode (SPERc) means the overall energy efficiency ratio of the air conditioner or comfort chiller using fuels, representative for the cooling season
seasonal gas utilisation efficiency in cooling mode (SGUEc) means the gas utilisation efficiency for the whole cooling season
gas utilisation efficiency at partial load means the gas utilisation efficiency when cooling (GUEc,bin) or heating (GUEh,bin) at outdoor temperature Tj
gas utilisation efficiency at declared capacity means the gas utilisation efficiency when cooling (GUEcDC) or heating (GUEhDC) at declared capacity conditions as defined in Annex III, Table 21, and corrected for possible cycling behaviour of the unit, in case the effective cooling capacity (QEc) exceeds the cooling load (Pc (Tj)) or the effective heating capacity (QEh) exceeds the heating load (Ph (Tj))
effective cooling capacity (QEc) means the measured cooling capacity corrected for the heat from the device (pump(s) or fan(s)) responsible for circulating the heat transfer medium through the indoor side heat exchanger, expressed in kW
effective heat recovery capacity means the measured heat recovery capacity corrected for the heat from the device (pump(s)) of the heat recovery circuit for cooling (QEhr,c) or heating (QEhr,h), expressed in kW
measured heat input for cooling (Qgmc) means the measured fuel input at part load conditions as defined in Annex III, Table 21, expressed in kW
seasonal auxiliary energy factor in cooling mode (SAEFc) means the auxiliary energy efficiency for the cooling season, including the contribution of thermostat-off mode, standby mode, off mode and crankcase heater mode power mode
reference annual cooling demand (QC) means the annual cooling demand, calculated as the design cooling load (Pdesign,c) multiplied by the equivalent active mode hours for cooling (HCE)
seasonal auxiliary energy factor in cooling mode in active mode (SAEFc,on) means the auxiliary energy efficiency for the cooling season, excluding the contribution of thermostat-off mode, standby mode, off mode and crankcase heater mode power modes
auxiliary energy factor in cooling mode at partial load (AEFc,bin) means the auxiliary energy efficiency when cooling at outdoor temperature (Tj)
electric power input in cooling mode (PEc) means the effective cooling electrical power input, in kW
seasonal primary energy ratio in heating mode (SPERh) means the overall energy efficiency ratio of the heat pump using fuels, representative for the heating season
seasonal gas utilisation efficiency in heating mode (SGUEh) means the gas utilisation efficiency for the heating season
effective heating capacity (QEh) means the measured heating capacity corrected for the heat from the device (pump(s) or fan(s)) responsible for circulating the heat transfer medium through the indoor side heat exchanger, expressed in kW
measured heat input for heating (Qgmh) means the measured fuel input at part load conditions as defined in Annex III Table 21, expressed in kW
seasonal auxiliary energy factor in heating mode (SAEFh) means the auxiliary energy efficiency for the heating season, including the contribution of thermostat-off mode, standby mode, off mode and crankcase heater mode power modes
reference annual heating demand (QH) means the annual heating demand, calculated as the design heating load multiplied by the annual equivalent active mode hours for heating (HHE)
seasonal auxiliary energy factor in heating mode in active mode (SAEFh,on) means the auxiliary energy efficiency for the heating season, excluding the contribution of thermostat-off mode, standby mode, off mode and crankcase heater mode power modes
auxiliary energy factor in heating mode at partial load (AEFh,bin) means the auxiliary energy efficiency when heating at outdoor temperature Tj
auxiliary energy factor at declared capacity means the auxiliary energy factor when cooling (AEFc,dc) or heating (AEFh,dc) at part load conditions as defined in Annex III, Table 21, and corrected for possible cycling behaviour of the unit, in case the effective cooling capacity (QEc) exceeds the cooling load (Pc (Tj)) or the effective heating capacity (QEh) exceeds the heating load (Ph (Tj))
electric power input in heating mode (PEh) means the effective heating electrical power input, in kW
NOx emissions of heat pumps, comfort chillers and air conditioners with an internal combustion engine means the emissions of the sum of nitrogen monoxide and nitrogen dioxide emissions, of heat pumps, comfort chillers and air conditioners with an internal combustion engine, measured at standard rating conditions, using engine rpm equivalent, expressed in mg nitrogen dioxide per kWh fuel input in terms of GCV
engine rpm equivalent (Erpmequivalent ) means the revolutions per minute of the internal combustion engine calculated on the basis of an engine rpm at 70, 60, 40 and 20 % part load ratios for heating (or cooling if no heating function is offered) and weighing factors of 0,15, 0,25, 0,30 and 0,30 respectively
rated power input (DA) means the electrical power input which is needed by the high temperature process chiller (including the compressor, the condenser fan(s) or pumps(s), the evaporator pump(s) and possible auxiliaries) to reach the rated refrigeration capacity, expressed in kW to two decimal places
rated energy efficiency ratio (EERA) means the rated refrigeration capacity, expressed in kW divided by the rated power input, expressed in kW, expressed to two decimal places
seasonal energy performance ratio (SEPR) is the efficiency ratio of a high temperature process chiller at standard rating conditions, representative of the variations in load and ambient temperature throughout the year, and calculated as the ratio between the annual refrigeration demand and the annual electricity consumption
annual refrigeration demand means the sum of each bin-specific refrigeration load multiplied by the corresponding number of bin hours
refrigeration load means the rated refrigeration capacity multiplied by the part load ratio of high temperature process chillers, expressed in kW to two decimal places
part load (PC (Tj)) means the refrigeration load at a specific ambient temperature (Tj ), calculated as the full load multiplied by the part load ratio of high temperature process chillers corresponding to the same ambient temperature Tj and expressed in kW at two decimal places
part load ratio of high temperature process chillers (PR (Tj)) means:
(a) for high temperature process chillers using air-cooled condensing, the ambient temperature Tj minus 5 °C divided by the reference ambient temperature minus 5 °C multiplied by 0,2 and added to 0,8. For ambient temperatures higher than the reference ambient temperature, the part load ratio of high temperature process chillers shall be 1. For ambient temperatures lower than 5 °C, the part load ratio of high temperature process chillers shall be 0,8;
(b) for high temperature process chillers using water-cooled condensing, the water inlet temperature (water inlet to condenser) minus 9 °C divided by the reference ambient temperature of the water inlet to condenser (30 °C) minus 9 °C, and multiplied by 0,2 and added to 0,8. For ambient temperatures (water inlet to condenser) higher than the reference ambient temperature, the part load ratio of high temperature process chillers shall be 1. For ambient temperatures lower than 9 °C (water inlet to condenser), the part load ratio of high temperature process chillers shall be 0,8;
(c) which is expressed as a percentage to one decimal place
annual electricity consumption is calculated as the sum of the ratios between each bin-specific cooling demand and the corresponding bin-specific energy efficiency ratio, multiplied by the corresponding number of bin hours
ambient temperature means:
(a) for high temperature process chillers using air-cooled condensing, the air dry bulb temperature, expressed in degrees Celsius;
(b) for high temperature process chillers using water-cooled condensing, the water inlet temperature at the condenser, expressed in degrees Celsius
reference ambient temperature means the ambient temperature, expressed in degrees Celsius, at which the part load ratio of high temperature process chillers is equal to 1. It shall be set at 35 °C. For air-cooled high temperature process chillers, the air inlet temperature to the condenser is defined as 35 °C while for water-cooled high temperature process chillers the water inlet temperature to the condenser is defined as 30 °C with 35 °C outdoor air temperature to the condenser
energy efficiency ratio at part load (EERPL (Tj)) means the energy efficiency ratio for every bin in the year, derived from the declared energy efficiency ratio (EERDC ) for specified bins and calculated for other bins by linear interpolation
declared refrigeration demand means the refrigeration load at specified bin conditions, and calculated as the rated refrigeration capacity multiplied by the corresponding part load ratio of high temperature process chillers
declared energy efficiency ratio (EERDC) means the energy efficiency ratio of the high temperature process chiller at a specific rating point, corrected where necessary by the degradation coefficient if the minimum declared refrigeration capacity exceeds the refrigeration load or interpolated if the nearest declared refrigeration capacities lie above and below the refrigeration load
declared power input means the electrical power input needed by the high temperature process chiller to meet the declared refrigeration capacity at a specific rating point
declared refrigeration capacity means the refrigeration capacity delivered by the high temperature process chiller to meet the declared refrigeration demand at a specific rating point
total electric power input (Pelec) means the total electric power absorbed by the unit, including fan(s) and auxiliary devices
flight message transfer protocol means a protocol for electronic communication comprising message formats, their encoding for interchange and sequence rules used for the information exchanges between flight data processing systems
flight data processing system means the part of an air traffic services system which receives, automatically processes and distributes to air traffic control units working positions, flight plan data and associated messages
air traffic control unit (ATC unit) means variously area control centre, approach control unit or aerodrome control tower
working position means the furniture and technical equipment at which a member of the air traffic services staff undertakes task associated with their job
area control centre (ACC) means a unit established to provide air traffic control service to controlled flights in control areas under its responsibility
civil-military coordination means the coordination between civil and military parties authorised to make decisions and agree a course of action
air traffic services unit (ATS unit) means a unit, civil or military, responsible for providing air traffic services
controlling military unit means any fixed or mobile military unit handling military air traffic and/or pursuing other activities that, due to their specific nature, may require airspace reservation or restriction
peer-to-peer communication mechanism means a mechanism for communication established between two ATC units or between ATS units and controlling military units in which each party has the same communication capabilities for the information exchange between flight data processing systems and either party can initiate the communication
HVDC system means an electrical power system which transfers energy in the form of high-voltage direct current between two or more alternating current (AC) buses and comprises at least two HVDC converter stations with DC transmission lines or cables between the HVDC converter stations
DC-connected power park module means a power park module that is connected via one or more HVDC interface points to one or more HVDC systems
embedded HVDC system means an HVDC system connected within a control area that is not installed for the purpose of connecting a DC-connected power park module at the time of installation, nor installed for the purpose of connecting a demand facility
HVDC converter station means part of an HVDC system which consists of one or more HVDC converter units installed in a single location together with buildings, reactors, filters, reactive power devices, control, monitoring, protective, measuring and auxiliary equipment
HVDC interface point means a point at which HVDC equipment is connected to an AC network, at which technical specifications affecting the performance of the equipment can be prescribed
DC-connected power park module owner means a natural or legal entity owning a DC-connected power park module
maximum HVDC active power transmission capacity (Pmax) means the maximum continuous active power which an HVDC system can exchange with the network at each connection point as specified in the connection agreement or as agreed between the relevant system operator and the HVDC system owner
minimum HVDC active power transmission capacity (Pmin) means the minimum continuous active power which an HVDC system can exchange with the network at each connection point as specified in the connection agreement or as agreed between the relevant system operator and the HVDC system owner
HVDC system maximum current means the highest phase current, associated with an operating point inside the U-Q/Pmax-profile of the HVDC converter station at maximum HVDC active power transmission capacity
HVDC converter unit means a unit comprising one or more converter bridges, together with one or more converter transformers, reactors, converter unit control equipment, essential protective and switching devices and auxiliaries, if any, used for the conversion
accepted market practice means a specific market practice that is accepted by a competent authority in accordance with Article 13
competent authority means an authority designated in accordance with Article 22, unless otherwise specified in this Regulation
person means a natural or legal person
spot commodity contract means a contract for the supply of a commodity traded on a spot market which is promptly delivered when the transaction is settled, and a contract for the supply of a commodity that is not a financial instrument, including a physically settled forward contract
spot market means a commodity market in which commodities are sold for cash and promptly delivered when the transaction is settled, and other non-financial markets, such as forward markets for commodities
emission allowance market participant means any person who enters into transactions, including the placing of orders to trade, in emission allowances, auctioned products based thereon, or derivatives thereof and who does not benefit from an exemption pursuant to the second subparagraph of Article 17(2)
issuer means a legal entity governed by private or public law, which issues or proposes to issue financial instruments, the issuer being, in case of depository receipts representing financial instruments, the issuer of the financial instrument represented
person discharging managerial responsibilities means a person within an issuer, an emission allowance market participant or another entity referred to in Article 19(10), who is:
(a) a member of the administrative, management or supervisory body of that entity; or
(b) a senior executive who is not a member of the bodies referred to in point (a), who has regular access to inside information relating directly or indirectly to that entity and power to take managerial decisions affecting the future developments and business prospects of that entity
person closely associated means:
(a) a spouse, or a partner considered to be equivalent to a spouse in accordance with national law;
(b) a dependent child, in accordance with national law;
(c) a relative who has shared the same household for at least one year on the date of the transaction concerned; or
(d) a legal person, trust or partnership, the managerial responsibilities of which are discharged by a person discharging managerial responsibilities or by a person referred to in point (a), (b) or (c), or which is directly or indirectly controlled by such a person, or which is set up for the benefit of such a person, or the economic interests of which are substantially equivalent to those of such a person
person professionally arranging or executing transactions means a person professionally engaged in the reception and transmission of orders for, or in the execution of transactions in, financial instruments
benchmark means any rate, index or figure, made available to the public or published that is periodically or regularly determined by the application of a formula to, or on the basis of the value of one or more underlying assets or prices, including estimated prices, actual or estimated interest rates or other values, or surveys, and by reference to which the amount payable under a financial instrument or the value of a financial instrument is determined
stake-building means an acquisition of securities in a company which does not trigger a legal or regulatory obligation to make an announcement of a takeover bid in relation to that company
disclosing market participant means a person who falls into any of the categories set out in points (a) to (d) of Article 11(1) or of Article 11(2), and discloses information in the course of a market sounding
information recommending or suggesting an investment strategy means information:
(i) produced by an independent analyst, an investment firm, a credit institution, any other person whose main business is to produce investment recommendations or a natural person working for them under a contract of employment or otherwise, which, directly or indirectly, expresses a particular investment proposal in respect of a financial instrument or an issuer; or
(ii) produced by persons other than those referred to in point (i), which directly proposes a particular investment decision in respect of a financial instrument
investment recommendations means information recommending or suggesting an investment strategy, explicitly or implicitly, concerning one or several financial instruments or the issuers, including any opinion as to the present or future value or price of such instruments, intended for distribution channels or for the public
securities means:
(i) shares and other securities equivalent to shares;
(ii) bonds and other forms of securitised debt; or
(iii) securitised debt convertible or exchangeable into shares or into other securities quivalent to shares
associated instruments means the following financial instruments, including those which are not admitted to trading or traded on a trading venue, or for which a request for admission to trading on a trading venue has not been made:
(i) contracts or rights to subscribe for, acquire or dispose of securities;
(ii) financial derivatives of securities;
(iii) where the securities are convertible or exchangeable debt instruments, the securities into which such convertible or exchangeable debt instruments may be converted or exchanged;
(iv) instruments which are issued or guaranteed by the issuer or guarantor of the securities and whose market price is likely to materially influence the price of the securities, or vice versa;
(v) where the securities are securities equivalent to shares, the shares represented by those securities and any other securities equivalent to those shares
significant distribution means an initial or secondary offer of securities that is distinct from ordinary trading both in terms of the amount in value of the securities to be offered and the selling method to be employed
stabilisation means a purchase or offer to purchase securities, or a transaction in associated instruments equivalent thereto, which is undertaken by a credit institution or an investment firm in the context of a significant distribution of such securities exclusively for supporting the market price of those securities for a predetermined period of time, due to a selling pressure in such securities
investment company with variable capital within the meaning of this Directive, means only those companies:
— the exclusive object of which is to invest their funds in various stocks and shares, land or other assets with the sole aim of spreading investment risks and giving their shareholders the benefit of the results of the management of their assets,
— which offer their own shares for subscription by the public, and
— the statutes of which provide that, within the limits of a minimum and maximum capital, they may at any time issue, redeem or resell their shares
electronic means means electronic equipment used for the processing, including digital compression, and the storage of data, and through which information is initially sent and received at its destination; that information being entirely transmitted, conveyed and received in a manner to be determined by Member States
formation means the whole process of establishing a company in accordance with national law, including the drawing up of the company’s instrument of constitution and all the necessary steps for the entry of the company in the register
registration of a branch means a process leading to disclosure of documents and information relating to a branch newly opened in a Member State
template means a model for the instrument of constitution of a company which is drawn up by Member States in compliance with national law and is used for the online formation of a company in accordance with Article 13g
investment company with fixed capital means only companies:
(a) the exclusive object of which is to invest their funds in various stocks and shares, land or other assets with the sole aim of spreading investment risks and giving their shareholders the benefit of the results of the management of their assets; and
(b) which offer their own shares for subscription by the public
company means a limited liability company of a type listed in Annex II that carries out a cross-border conversion
cross-border conversion means an operation whereby a company, without being dissolved or wound up or going into liquidation, converts the legal form under which it is registered in a departure Member State into a legal form of the destination Member State, as listed in Annex II, and transfers at least its registered office to the destination Member State, while retaining its legal personality
departure Member State means a Member State in which a company is registered prior to a cross-border conversion
destination Member State means a Member State in which a converted company is registered as a result of a cross-border conversion
converted company means a company formed in a destination Member State as a result of a cross-border conversion
merger by acquisition shall mean the operation whereby one or more companies are wound up without going into liquidation and transfer to another all their assets and liabilities in exchange for the issue to the shareholders of the company or companies being acquired of shares in the acquiring company and a cash payment, if any, not exceeding 10 % of the nominal value of the shares so issued or, where they have no nominal value, of their accounting par value
merger by the formation of a new company shall mean the operation whereby several companies are wound up without going into liquidation and transfer to a company that they set up all their assets and liabilities in exchange for the issue to their shareholders of shares in the new company and a cash payment, if any, not exceeding 10 % of the nominal value of the shares so issued or, where they have no nominal value, of their accounting par value
limited liability company means:
(a) a company of a type listed in Annex II; or
(b) a company with share capital and having legal personality, possessing separate assets which alone serve to cover its debts and that is subject, under the national law governing it, to conditions concerning guarantees such as are provided for by Section 2 of Chapter II of Title I and Section 1 of Chapter III of Title I for the protection of the interests of members and others
merger means an operation whereby:
(a) one or more companies, on being dissolved without going into liquidation, transfer all their assets and liabilities to another existing company, the acquiring company, in exchange for the issue to their members of securities or shares representing the capital of that other company and, if applicable, a cash payment not exceeding 10 % of the nominal value, or, in the absence of a nominal value, of the accounting par value of those securities or shares; or
(b) two or more companies, on being dissolved without going into liquidation, transfer all their assets and liabilities to a company that they form, the new company, in exchange for the issue to their members of securities or shares representing the capital of that new company and, if applicable, a cash payment not exceeding 10 % of the nominal value, or in the absence of a nominal value, of the accounting par value of those securities or shares; or
(c) a company, on being dissolved without going into liquidation, transfers all its assets and liabilities to the company holding all the securities or shares representing its capital; or
(d) one or more companies, on being dissolved without going into liquidation, transfer all their assets and liabilities to another existing company, the acquiring company, without the issue of any new shares by the acquiring company, provided that one person holds directly or indirectly all the shares in the merging companies or the members of the merging companies hold their securities and shares in the same proportion in all merging companies
division by acquisition shall mean the operation whereby, after being wound up without going into liquidation, a company transfers to more than one company all its assets and liabilities in exchange for the allocation to the shareholders of the company being divided of shares in the companies receiving contributions as a result of the division and possibly a cash payment not exceeding 10 % of the nominal value of the shares allocated or, where they have no nominal value, of their accounting par value
division by the formation of new companies means the operation whereby, after being wound up without going into liquidation, a company transfers to more than one newly-formed company all its assets and liabilities in exchange for the allocation to the shareholders of the company being divided of shares in the recipient companies, and possibly a cash payment not exceeding 10 % of the nominal value of the shares allocated or, where they have no nominal value, of their accounting par value
company means a limited liability company of a type listed in Annex II
company being divided means a company which, in the process of a cross-border division, transfers all its assets and liabilities to two or more companies in the case of a full division, or transfers part of its assets and liabilities to one or more companies in the case of a partial division or division by separation
recipient company means a company newly formed in the course of a cross-border division
division means an operation whereby:
(a) a company being divided, on being dissolved without going into liquidation, transfers all its assets and liabilities to two or more recipient companies, in exchange for the issue to the members of the company being divided of securities or shares in the recipient companies and, if applicable, a cash payment not exceeding 10 % of the nominal value, or, in the absence of a nominal value, a cash payment not exceeding 10 % of the accounting par value of those securities or shares (‘full division’);
(b) a company being divided transfers part of its assets and liabilities to one or more recipient companies, in exchange for the issue to the members of the company being divided of securities or shares in the recipient companies, in the company being divided or in both the recipient companies and the company being divided, and, if applicable, a cash payment not exceeding 10 % of the nominal value, or, in the absence of a nominal value, a cash payment not exceeding 10 % of the accounting par value of those securities or shares (‘partial division’); or
(c) a company being divided transfers part of its assets and liabilities to one or more recipient companies, in exchange for the issue to the company being divided of securities or shares in the recipient companies (‘division by separation’).
local space heater means a space heating device that emits heat by direct heat transfer or by direct heat transfer in combination with heat transfer to a fluid, in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated, possibly combined with a heat output to other spaces and is equipped with one or more heat generators that convert electricity or gaseous, liquid or solid fuels directly into heat, through use of the Joule effect or combustion of fuels respectively
solid fuel local space heater means an open fronted local space heater, closed fronted local space heater or cooker using solid fuels
gaseous fuel local space heater means an open fronted local space heater or a closed fronted local space heater using gaseous fuel
liquid fuel local space heater means an open fronted local space heater or a closed fronted local space heater using liquid fuel
electric local space heater means a local space heater using the electric Joule effect to generate heat
open fronted local space heater means a local space heater, using gaseous, liquid or solid fuels, of which the fire bed and combustion gases are not sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
closed fronted local space heater means a local space heater, using gaseous, liquid or solid fuels, of which the fire bed and combustion gases can be sealed from the space in which the product is fitted and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
cooker means a local space heater, using solid fuels, that integrates in one enclosure the function of a local space heater, and a hob, an oven or both to be used for preparation of food and which is sealed to a chimney or fireplace opening or requires a flue duct for the evacuation of products of combustion
fuel fired local space heater means either an open fronted local space heater, closed fronted local space heater or cooker
luminous local space heater means a local space heater, using gaseous or liquid fuel which is equipped with a burner; which is to be installed above head level, directed towards the place of use so that the heat emission of the burner, being predominantly infrared radiation, directly warms the subjects to be heated and which emits the products of combustion in the space where it is situated
tube local space heater means a local space heater, using gaseous or liquid fuel, which is equipped with a burner; which is to be installed above head level, near the subjects to be heated, which heats the space primarily by infrared radiation from the tube or tubes heated by the internal passage of products of combustion and of which the products of combustion are to be evacuated through a flue duct
flueless heater means a local space heater, using gaseous, liquid or solid fuel, emitting the products of combustion into the space where the product is situated, other than a luminous local space heater
open to chimney heater means a local space heater, using gaseous, liquid or solid fuels intended to sit under a chimney or in a fireplace without sealing between the product and the chimney or fireplace opening, and allowing the products of combustion pass unrestricted from the fire bed to the chimney or flue
air heating product means a product providing heat to an air-based heating system only that can be ducted and is designed to be used while fastened or secured in a specific location or wall mounted which distributes the air by means of an air moving device in order to reach and maintain a certain level of human thermal comfort within an enclosed space in which the product is situated
sauna stove means a local space heater, incorporated in, or declared to be used in, dry or wet sauna's or similar environments
solid fuel means a fuel which is solid at normal indoor room temperatures, including solid biomass and solid fossil fuel
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
woody biomass means biomass originating from trees, bushes and shrubs, including log wood, chipped wood, compressed wood in the form of pellets, compressed wood in the form of briquettes, and sawdust
non-woody biomass means biomass other than woody biomass, including, inter alia, straw, miscanthus, reeds, kernels, grains, olive stones, olive cakes and nut shells
preferred fuel means the single fuel which is to be preferably used for the local space heater according to the supplier's instructions
fossil solid fuel means solid fuel other than biomass, including anthracite and dry steam coal, hard coke, low temperature coke, bituminous coal, lignite, a blend of fossil fuels or a blend of biomass and fossil fuel; for the purposes of this Regulation it also includes peat
other suitable fuel means a fuel, other than the preferred fuel, which can be used in the local space heater according to the supplier's instructions and includes any fuel that is mentioned in the instruction manual for installers and end-users, on free access websites of manufacturers and suppliers, in technical or promotional material and in advertisements
direct heat output means the heat output of the product by radiation and convection of heat, as emitted by or from the product itself to air, excluding the heat output of the product to a heat transfer fluid, expressed in kW
indirect heat output means the heat output of the product to a heat transfer fluid by the same heat generation process that provides the direct heat output of the product, expressed in kW
indirect heating functionality means the product is capable of transferring part of the total heat output to a heat transfer fluid, for use as space heating or domestic hot water generation
nominal heat output (Pnom) means the heat output of a local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the maximum heat output that can be maintained over an extended period, as declared by the supplier, expressed in kW
minimum heat output (Pmin) means the heat output of a local space heater comprising both direct heat output and indirect heat output (where applicable), when operating at the setting for the lowest heat output, as declared by the supplier, expressed in kW
intended for outdoor use means the product is suitable for safe operation outside enclosed spaces, including possible use in outdoor conditions
equivalent model means a model placed on the market with the same technical parameters set out in Table 2 or Table 3 of Annex V as another model placed on the market by the same supplier
conversion coefficient (CC) means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient is CC = 2,5
net calorific value (NCV) means the total amount of heat released by a unit quantity of fuel containing the appropriate moisture of the fuel, when it is burned completely with oxygen, and when the products of combustion are not returned to ambient temperature
useful efficiency, at either nominal or minimum heat output, (ηth,nom or ηth,min respectively) means the ratio of the useful heat output and the total energy input expressed in terms of NCV of a local space heater, expressed in %
electric power requirement at nominal heat output (elmax) means the electric power consumption of the local space heater while providing the nominal heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement at minimum heat output (elmin) means the electric power consumption of the local space heater while providing the minimum heat output. The electric power consumption shall be established without consideration of the power consumption of a circulator in case the product offers indirect heating functionality and a circulator is incorporated, expressed in kW
electric power requirement in standby mode (elsb) means the electric power consumption of the product while in standby mode, expressed in kW
permanent pilot flame power requirement (Ppilot) means the fuel consumption of gaseous, liquid or solid fuel of the product for the provision of a flame to serve as an ignition source for the more powerful combustion process needed for nominal or part load heat output, when lit for more than 5 minutes before the main burner is on, expressed in kW
single stage heat output, no room temperature control means the product is not capable of varying its heat output automatically and that no feedback of room temperature is present to adapt the heat output automatically
two or more manual stages, no room temperature control means the product is capable of varying its heat output manually by two or more levels of heat output and is not equipped with a device that automatically regulates the heat output in relation to a desired indoor temperature
with mechanic thermostat room temperature control means the product is equipped with a non-electronic device that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort
with electronic room temperature control plus day timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature level for a 24-hours timer interval
with electronic room temperature control plus week timer means the product is equipped with an electronic device, either integrated or external, that allows the product to automatically vary its heat output over a certain time period, in relation to a certain required level of indoor heating comfort, and allows the setting of timing and temperature levels for a full week. During the 7-day period the settings must allow a variation on a day-to-day basis
room temperature control, with presence detection means the product is equipped with an electronic device, either integrated or external, that automatically reduces the set-point for the room temperature when no person is detected in the room
room temperature control, with open window detection means the product is equipped with an electronic device, either integrated or external, that reduces the heat output when a window or door has been opened. Whenever a sensor is used to detect the opening of a window or door, it can be installed with the product, externally to the product, built in the building structure or as a combination of those options
with distance control option means the function that allows remote interaction from outside the building in which the product is installed with the control of the product
standby mode means a condition where the product is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display
model identifier means the code, usually alphanumeric, which distinguishes a specific local space heater model from other models with the same trade mark, supplier's name or dealer's name
other fossil fuel means fossil fuel other than anthracite and dry steam coal, hard coke, low temperature coke, bituminous coal, lignite, peat or blended fossil fuel briquettes
other woody biomass means woody biomass other than log wood with a moisture content of 25 % or less, briquetted fuel with a moisture content below 14 % or compressed wood with a moisture content below 12 %
moisture content means the mass of water in the fuel in relation to the total mass of the fuel as used in the local space heater
display mechanism means any screen, including tactile screen, or other visual technology used for displaying internet content to users
nested display means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set
tactile screen means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone
alternative text means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications
solid fuel boiler means a device equipped with one or more solid fuel heat genererators that provides heat to a water-based central heating system in order to reach and maintain at a desired level the indoor temperature of one or more enclosed spaces, with a heat loss to its surrounding environment of not more than 6 % of rated heat output
water-based central heating system means a system using water as a heat transfer medium to distribute centrally generated heat to heat emitting devices for the heating of enclosed spaces within buildings or parts thereof, including block heating or district heating networks
solid fuel heat generator means the part of a solid fuel boiler that generates the heat through the combustion of solid fuels
rated heat output or Pr means the declared heat output of a solid fuel boiler when providing heating of enclosed spaces with the preferred fuel, expressed in kW
solid fuel means a fuel that is solid at normal indoor room temperatures, including solid biomass and solid fossil fuel
biomass means the biodegradable fraction of products, waste and residues from biological origin from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as the biodegradable fraction of industrial and municipal waste
woody biomass means biomass originating from trees, bushes and shrubs, including log wood, chipped wood, compressed wood in the form of pellets, compressed wood in the form of briquettes, and sawdust
non-woody biomass means biomass other than woody biomass, including straw, miscanthus, reeds, kernels, grains, olive stones, olive cakes and nut shells
fossil fuel means fuel other than biomass, including anthracite, brown coal, coke, bituminous coal; for the purposes of this Regulation it also includes peat
biomass boiler means a solid fuel boiler that uses biomass as the preferred fuel
non-woody biomass boiler means a biomass boiler that uses non-woody biomass as the preferred fuel and for which woody biomass, fossil fuel or a blend of biomass and fossil fuel are not listed among its other suitable fuels
preferred fuel means the single solid fuel which is to be preferably used for the boiler according to the supplier's instructions
other suitable fuel means a solid fuel, other than the preferred fuel, which can be used in the solid fuel boiler according to the supplier's instructions and includes any fuel that is mentioned in the instruction manual for installers and end-users, on free access websites of suppliers, in technical promotional material and in advertisements
solid fuel cogeneration boiler means a solid fuel boiler capable of simultaneously generating heat and electricity
supplementary heater means a secondary boiler or heat pump falling within the scope of Delegated Regulation (EU) No 811/2013 or a secondary solid fuel boiler, which generates extra heat where the heat demand is greater than the rated heat output of the primary solid fuel boiler
temperature control means the equipment that interfaces with the end-user regarding the values and timing of the desired indoor temperature, and communicates relevant data to an interface of the solid fuel boiler such as a central processing unit, thus helping to regulate the indoor temperature(s)
solar device means a solar-only system, a solar collector, a solar hot water storage tank or a pump in the collector loop, which are placed on the market separately
solar-only system means a device that is equipped with one or more solar collectors and solar hot water storage tanks and possibly pumps in the collector loop and other parts, which is placed on the market as one unit and is not equipped with any heat generator except possibly one or more back-up immersion heaters
solar collector means a device designed to absorb global solar irradiance and to transfer the heat energy so produced to a fluid passing through it
solar hot water storage tank means a hot water storage tank storing heat energy produced by one or more solar collectors
hot water storage tank means a vessel for storing hot water for water or space heating purposes, including any additives, which is not equipped with any heat generator except possibly one or more back-up immersion heaters
back-up immersion heater means a Joule effect electric resistance heater that is part of a hot water storage tank and generates heat only when the external heat source supply is disrupted (including during maintenance periods) or out of order, or that is part of a solar hot water storage tank and provides heat when the solar heat source is not sufficient to satisfy required comfort levels
package of a solid fuel boiler, supplementary heaters, temperature controls and solar devices means a package offered to the end-user containing a solid fuel boiler combined with one or more supplementary heaters, one or more temperature controls or one or more solar devices
combination boiler means a solid fuel boiler that is designed to also provide heat to deliver hot drinking or sanitary water at given temperature levels, quantities and flow rates during given intervals, and is connected to an external supply of drinking or sanitary water
model identifier means the code, usually alphanumeric, which distinguishes a specific model comprising a solid fuel boiler or a package of a solid fuel boiler, supplementary heaters, temperature controls and solar devices from other models with the same trade mark, supplier's name or dealer's name
seasonal space heating energy efficiency or ηs means the ratio between the space heating demand for a designated heating season, supplied by a solid fuel boiler and the annual energy consumption required to meet this demand, expressed in %
electrical efficiency or ηel means the ratio of the electricity output and the total energy input of a solid fuel cogeneration boiler, whereby the total energy input is expressed in terms of GCV or in terms of final energy multiplied by CC
gross calorific value or GCV means the total amount of heat released by a unit quantity of fuel containing the appropriate moisture content, when it is burned completely with oxygen, and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of the water vapour formed by the combustion of any hydrogen contained in the fuel
conversion coefficient or CC means a coefficient reflecting the estimated 40 % average EU generation efficiency referred to in Directive 2012/27/EU of the European Parliament and of the Council; the value of the conversion coefficient is CC = 2,5
temperature control fiche means the product fiche required to be provided for temperature controls by Article 3(3)(a) of Commission Delegated Regulation (EU) No 811/2013
boiler fiche means for solid fuel boilers the product fiche required to be provided by Article 3(1)(c) of this Regulation and for boilers other than solid fuel boilers the product fiche required to be provided for such boilers by Article 3(1)(b) of Commission Delegated Regulation (EU) No 811/2013
solar device fiche means the product fiche required to be provided for solar devices by Article 3(4)(a) of Commission Delegated Regulation (EU) No 811/2013
heat pump fiche means the product fiche required to be provided for heat pumps by Article 3(1)(b) of Commission Delegated Regulation (EU) No 811/2013
condensing boiler means a solid fuel boiler in which, under normal operating conditions and at given operating water temperatures, the water vapour in the combustion products is partially condensed, in order to make use of the latent heat of this water vapour for heating purposes
other woody biomass means woody biomass other than: log wood with a moisture content of 25 % or less, chipped wood with a moisture content of 15 % or higher, compressed wood in the form of pellets or briquettes, or sawdust with a moisture content equal or less than 50 %
moisture content means the mass of water in the fuel in relation to the total mass of the fuel as used in solid fuel boilers
other fossil fuel means fossil fuel other than bituminous coal, brown coal (including briquettes), coke, anthracite or blended fossil fuel briquettes
electric power requirement at maximum heat output or elmax means the electric power consumption of the solid fuel boiler at rated heat output, expressed in kW, excluding electricity consumption from a back-up heater and from incorporated secondary emission abatement equipment
electric power requirement at minimum heat output or elmin means the electric power consumption of the solid fuel boiler at applicable part load, expressed in kW, excluding electricity consumption from a back-up heater and from incorporated secondary emission abatement equipment
back-up heater means a Joule-effect electric resistance element that generates heat only to prevent the solid fuel boiler or the water based central heating system from freezing or when the external heat source supply is disrupted (including during maintenance periods) or out of order
applicable part load means for automatically stoked solid fuel boilers, operation at 30 % of rated heat output, and for manually stoked solid fuel boilers that can be operated at 50 % of rated heat output, operation at 50 % of rated heat output
standby mode power consumption or PSB means the power consumption of a solid fuel boiler in standby mode, excluding from incorporated secondary emission abatement equipment, expressed in kW
standby mode means a condition where the solid fuel boiler is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only the following functions, which may persist for an indefinite time: reactivation function, or reactivation function and only an indication of enabled reactivation function, or information or status display
seasonal space heating energy efficiency in active mode or ηson means
(a) for automatically stoked solid fuel boilers, a weighted average of the useful efficiency at rated heat output and the useful efficiency at 30 % of the rated heat output;
(b) for manually stoked solid fuel boilers that can be operated at 50 % of the rated heat output in continuous mode, a weighted average of the useful efficiency at rated heat output and the useful efficiency at 50 % of the rated heat output;
(c) for manually stoked solid fuel boilers that cannot be operated at 50 % or less of the rated heat output in continuous mode, the useful efficiency at rated heat output;
(d) for solid fuel cogeneration boilers, the useful efficiency at rated heat output
useful efficiency or η means the ratio of the useful heat output and the total energy input of a solid fuel boiler, whereby the total energy input is expressed in terms of GCV or in terms of final energy multiplied by CC
useful heat output or P means the heat output of a solid fuel boiler transmitted to the heat carrier, expressed in kW
fossil fuel boiler means a solid fuel boiler that has fossil fuel or a blend of biomass and fossil fuel as the preferred fuel
gross calorific value moisture free or GCVmf means the total amount of heat released by a unit quantity of fuel dried of inherent moisture, when it is burned completely with oxygen, and when the products of combustion are returned to ambient temperature; this quantity includes the condensation heat of the water vapour formed by the combustion of any hydrogen contained in the fuel
equivalent model means a model placed on the market with the same technical parameters set out in Table 4 of point 1 of Annex V, as another model placed on the market by the same supplier
display mechanism means any screen, including tactile screen, or other visual technology used for displaying internet content to users
nested display means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set
tactile screen means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone
alternative text means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications
professional refrigerated storage cabinet means an insulated refrigerating appliance integrating one or more compartments accessible via one or more doors or drawers, capable of continuously maintaining the temperature of foodstuffs within prescribed limits at chilled or frozen operating temperature, using a vapour compression cycle, and intended for the storage of foodstuffs in non-household environments but not for the display to or access by customers
foodstuffs means food, ingredients, beverages, including wine, and other items primarily intended for consumption which require refrigeration at specified temperatures
built-in cabinet means a fixed insulated refrigerating appliance intended to be installed in a cabinet, in a prepared recess in a wall or similar location, and requiring furniture finishing
roll-in cabinet means a professional refrigerated storage cabinet including one unique compartment that allows wheeled racks of product to be wheeled in
pass-through cabinet means a professional refrigerated storage cabinet accessible from both sides
static-air cabinet means a professional refrigerated storage cabinet without internal forced-air circulation, specifically designed to store temperature-sensitive foodstuffs or to avoid a drying effect on foodstuffs stored without a sealed enclosure, where a single static air compartment within the cabinet is not sufficient to designate the cabinet as a static air cabinet
open cabinet means a professional refrigerated storage cabinet whose refrigerated enclosure can be reached from the outside without opening a door or a drawer, where the mere presence of one compartment which can be reached from the outside without opening a door or a drawer, with a net volume equivalent to less than 20 % of the professional refrigerated storage cabinet's total volume, is not sufficient to qualify it as such
saladette means a professional refrigerated storage cabinet with one or more doors or drawer fronts in the vertical plane that has cut-outs in the top surface into which temporary storage bins can be inserted for easy-access storage of foodstuffs such as, but not limited to, pizza toppings or salad items
combined cabinet means a professional refrigerated storage cabinet including two or more compartments with different temperatures for the refrigeration and storage of foodstuffs
refrigerator-freezer means a type of combined cabinet including at least one compartment exclusively intended for chilled operating temperature and one compartment exclusively intended for frozen operating temperature
chest freezer means a food freezer in which the compartment(s) is accessible from the top of the appliance or which has both top-opening type and upright type compartments but where the gross volume of the top-opening type compartment(s) exceeds 75 % of the total gross volume of the appliance
net volume means the volume containing foodstuffs within the load limit
chilled operating temperature means that the temperature of foodstuffs stored in the cabinet is continuously maintained at a temperature between – 1 °C and 5 °C
frozen operating temperature means that the temperature of foodstuffs stored in the cabinet is continuously maintained at a temperature lower than – 15 °C, which is understood as the highest temperature of the warmest package test
multi-use cabinet means that a professional refrigerated storage cabinet or separate compartment of the same cabinet may be set at different temperatures for chilled or frozen foodstuffs
vertical cabinet means a professional refrigerated storage cabinet of overall height equal to or higher than 1 050 mm with one or more front doors or drawers accessing the same compartment
counter cabinet means a professional refrigerated storage cabinet of overall height lower than 1 050 mm with one or more front doors or drawers accessing the same compartment
light-duty cabinet, also known as semi-professional cabinet means a professional refrigerated storage cabinet only capable of continuously maintaining chilled or frozen operating temperature in all its compartment(s) in ambient conditions corresponding to climate class 3, as detailed in Table 3 of Annex IX; if the cabinet is able to maintain temperature in ambient conditions corresponding to climate class 4, it shall not be considered a light-duty cabinet
heavy-duty cabinet means a professional refrigerated storage cabinet capable of continuously maintaining chilled or frozen operating temperature in all its compartment(s) in ambient conditions corresponding to climate class 5, as detailed in Table 3 in Annex IX
equivalent professional refrigerated storage cabinet means a professional refrigerated storage cabinet model placed on the market with the same net volume, same technical, efficiency and performance characteristics, and same compartment types and volumes as another professional refrigerated storage cabinet model placed on the market under a different commercial code number by the same manufacturer
display mechanism means any screen, including tactile screen, or other visual technology used for displaying internet content to users
nested display means visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set
tactile screen means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone
alternative text means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications
oven means an appliance or part of an appliance which incorporates one or more cavities using electricity and/or gas in which food is prepared by use of a conventional or fan-forced mode
cavity means the enclosed compartment in which the temperature can be controlled for preparation of food
multi-cavity oven means an oven with two or more cavities, each of which is heated separately
small oven means an oven where all cavities have a width and depth of less than 250 mm or a height less than 120 mm
portable oven means an oven with a product mass of less than 18 kilograms, provided it is not designed for built-in installations
microwave heating means heating of food using electromagnetic energy
conventional mode means the operation mode of an oven only using natural convection for circulation of heated air inside the cavity of the oven
fan-forced mode means a mode when a built-in fan circulates heated air inside the cavity of the oven
cycle means the period of heating a standardised load in a cavity of an oven under defined conditions
cooker means an appliance consisting of an oven and a hob using gas or electricity
operation mode means the status of the oven or hob during use
heat source means the main energy form for heating an oven or hob
electric hob means an appliance or part of an appliance which incorporates one or more cooking zones and/or cooking areas including a control unit and which is heated by electricity
gas hob means an appliance or part of an appliance which incorporates one or more cooking zones including a control unit and which is heated by gas burners of a minimum power of 1,16 kW
hob means an ‘electric hob’, a ‘gas hob’ or a ‘mixed hob’
covered gas burner means closed or sealed gas range burners covered with a heavy-duty glass or ceramic cover, which forms a smooth, seamless cooking surface
mixed hob means an appliance with one or more electrically heated cooking zones or areas and one or more cooking zones heated by gas burners
cooking zone means a part, with a diameter of at least 100 mm, of a hob where cookware is placed and heated with not more than one piece of cookware heated at a time; the area of the cooking zone may be visibly marked on the surface of the hob
cooking area means a part of an area of an electric hob heated by an inducted magnetic field, where cookware is placed for heating without visible marking for the cookware and where more than one item of cookware can be used simultaneously
range hood means an appliance, operated by a motor which it controls, intended to collect contaminated air from above a hob, or which includes a downdraft system intended for installation adjacent to cooking ranges, hobs and similar cooking products, that draws vapour down into an internal exhaust duct
automatic functioning mode during the cooking period means a condition in which the air flow of the range hood during the cooking period is automatically controlled through sensor(s), including as regards humidity, temperature, etc.
fully automatic range hood means a range hood in which the air flow and/or other functions are automatically controlled through sensor(s) during 24 hours including the cooking period
best efficiency point (BEP) means the range hood operating point with maximum fluid dynamic efficiency (FDEhood)
average illumination (Emiddle) means the average illumination provided by the lighting system of the range hood on the cooking surface, measured in lux
off mode means a condition in which the equipment is connected to the mains power source but is not providing any function, or only provides an indication of off-mode condition, or only provides functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2004/108/EC of the European Parliament and of the Council
standby mode means a condition where the equipment is connected to the mains power source, depends on energy input from the mains power source to work as intended and provides only reactivation function, or reactivation function and only an indication of enabled reactivation function, and/or information or status display, which may persist for an indefinite time
reactivation function means a function facilitating the activation of other modes, including the active mode, by remote switch including remote control, internal sensor, or timer to a condition providing additional functions, including the main function
information or status display means a continuous function providing information or indicating the status of the equipment on a display, including clocks
end-user means a consumer buying or expected to buy a product
equivalent model means a model placed on the market with the same technical parameters as another model placed on the market under a different commercial code number by the same manufacturer or importer
coal means high-grade, medium-grade and low-grade category A and B coal within the meaning of the international codification system for coal laid down by the United Nations Economic Commission for Europe
closure means the permanent cessation of production and sale of coal
closure plan means a plan drawn up by a Member State providing for measures culminating in the definitive closure of coal production units
coal production unit means underground or opencast coal workings and related infrastructure capable of producing raw coal independently of other parts of the undertaking
coal year means calendar year or another 12-month period used as a reference for contracts in the coal industry
production costs means total costs related to current production, including mining operations, operations for the dressing of coal, in particular washing, sizing and sorting, and transport to the utilization point, normal depreciation and market-based interest charges on borrowed capital
current production losses means the positive difference between the coal production cost and the selling price at utilisation point freely agreed between the contracting parties in the light of the conditions prevailing on the world market
reference period shall mean a period to which data refer
reference year shall mean a reference period of one calendar year
collection period shall mean a period specified in implementing measures during which a collection of data takes place
acquirer means a payment service provider contracting with a payee to accept and process card-based payment transactions, which result in a transfer of funds to the payee
issuer means a payment service provider contracting to provide a payer with a payment instrument to initiate and process the payer's card-based payment transactions
consumer means a natural person who, in payment service contracts covered by this Regulation, is acting for purposes other than the trade, business or profession of that person
debit card transaction means a card-based payment transaction, including those with prepaid cards that is not a credit card transaction
credit card transaction means a card-based payment transaction where the amount of the transaction is debited in full or in part at a pre agreed specific calendar month date to the payer, in line with a prearranged credit facility, with or without interest
commercial card means any card-based payment instrument issued to undertakings or public sector entities or self-employed natural persons which is limited in use for business expenses where the payments made with such cards are charged directly to the account of the undertaking or public sector entity or self-employed natural person
card-based payment transaction means a service based on a payment card scheme's infrastructure and business rules to make a payment transaction by means of any card, telecommunication, digital or IT device or software if this results in a debit or a credit card transaction. Card-based payment transactions exclude transactions based on other kinds of payment services
cross-border payment transaction means a card-based payment transaction where the issuer and the acquirer are located in different Member States or where the card-based payment instrument is issued by an issuer located in a Member State different from that of the point of sale
domestic payment transaction means any card-based payment transaction which is not a cross-border payment transaction
interchange fee means a fee paid for each transaction directly or indirectly (i.e. through a third party) between the issuer and the acquirer involved in a card-based payment transaction. The net compensation or other agreed remuneration is considered to be part of the interchange fee
net compensation means the total net amount of payments, rebates or incentives received by an issuer from the payment card scheme, the acquirer or any other intermediary in relation to card-based payment transactions or related activities
merchant service charge means a fee paid by the payee to the acquirer in relation to card-based payment transactions
payee means a natural or legal person who is the intended recipient of funds which have been the subject of a payment transaction
payer means a natural or legal person who holds a payment account and allows a payment order from that payment account, or, where there is no payment account, a natural or legal person who gives a payment order
payment card means a category of payment instrument that enables the payer to initiate a debit or credit card transaction
payment card scheme means a single set of rules, practices, standards and/or implementation guidelines for the execution of card-based payment transactions and which is separated from any infrastructure or payment system that supports its operation, and includes any specific decision-making body, organisation or entity accountable for the functioning of the scheme
four party payment card scheme means a payment card scheme in which card-based payment transactions are made from the payment account of a payer to the payment account of a payee through the intermediation of the scheme, an issuer (on the payer's side) and an acquirer (on the payee's side)
three party payment card scheme means a payment card scheme in which the scheme itself provides acquiring and issuing services and card-based payment transactions are made from the payment account of a payer to the payment account of a payee within the scheme. When a three party payment card scheme licenses other payment service providers for the issuance of card-based payment instruments or the acquiring of card-based payment transactions, or both, or issues card-based payment instruments with a co-branding partner or through an agent, it is considered to be a four party payment card scheme
payment instrument means any personalised device(s) and/or set of procedures agreed between the payment service user and the payment service provider and used in order to initiate a payment order
card-based payment instrument means any payment instrument, including a card, mobile phone, computer or any other technological device containing the appropriate payment application which enables the payer to initiate a card-based payment transaction which is not a credit transfer or a direct debit as defined by Article 2 of Regulation (EU) No 260/2012
payment application means computer software or equivalent loaded on a device enabling card-based payment transactions to be initiated and allowing the payer to issue payment orders
payment account means an account held in the name of one or more payment service users which is used for the execution of payment transactions, including through a specific account for electronic money as defined in point 2 of Article 2 of Directive 2009/110/EC of the European Parliament and of the Council
payment order eans any instruction by a payer to its payment service provider requesting the execution of a payment transaction
payment service provider means any natural or legal person authorised to provide the payment services listed in the Annex to Directive 2007/64/EC or recognised as an electronic money issuer in accordance with Article 1(1) of Directive 2009/110/EC. A payment service provider can be an issuer or an acquirer or both
payment service user means a natural or legal person making use of a payment service in the capacity of either payer or payee, or both
payment transaction means an action, initiated by the payer or on its behalf or by the payee of transferring funds, irrespective of any underlying obligations between the payer and the payee
processing means the performance of payment transaction processing services in terms of the actions required for the handling of a payment instruction between the acquirer and the issuer
processing entity means any natural or legal person providing payment transaction processing services
point of sale means the address of the physical premises of the merchant at which the payment transaction is initiated. However:
(a) in the case of distance sales or distance contracts (i.e. e-commerce) as defined in point 7 of Article 2 of Directive 2011/83/EU, the point of sale shall be the address of the fixed place of business at which the merchant conducts its business regardless of website or server locations through which the payment transaction is initiated;
(b) in the event that the merchant does not have a fixed place of business, the point of sale shall be the address for which the merchant holds a valid business licence through which the payment transaction is initiated;
(c) in the event that the merchant does not have a fixed place of business nor a valid business licence, the point of sale shall be the address for correspondence for the payment of its taxes relating to its sales activity through which the payment transaction is initiated
payment brand means any material or digital name, term, sign, symbol or combination thereof, capable of denoting under which payment card scheme card-based payment transactions are carried out
co-badging means the inclusion of two or more payment brands or payment applications of the same brand on the same card-based payment instrument
co-branding means the inclusion of at least one payment brand and at least one non-payment brand on the same card-based payment instrument
debit card means a category of payment instrument that enables the payer to initiate a debit card transaction excluding those with prepaid cards
credit card means a category of payment instrument that enables the payer to initiate a credit card transaction
prepaid card means a category of payment instrument on which electronic money, as defined in point 2 of Article 2 of Directive 2009/110/EC, is stored
Union list means the list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008
evaluated flavouring substances means substances for which the evaluation and approval have been completed at Union level. Those substances are assigned no footnotes in Part A of the Union list of flavourings and source materials
flavouring substances under evaluation means substances for which the risk assessment at Union level has not been completed at the time of entry into force of this Regulation. Those substances are assigned footnotes 1 to 4 in Part A of the Union list of flavourings and source materials
Status of Qualified Presumption of Safety means the safety status assigned by the Authority to selected groups of micro-organisms on the basis of an assessment showing no safety concerns
SCF guidelines of 1992 means the guidelines for the presentation of data on food enzymes set out in the opinion expressed by the Scientific Committee for Food on 11 April 1991
approved food additive means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs, Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners
business operator means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control
interested business operator means a business operator interested in the continuity of the authorisation of one or more approved food additives
original dossier means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009
claim means any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics
nutrient means protein, carbohydrate, fat, fibre, sodium, vitamins and minerals listed in the Annex to Directive 90/496/EEC, and substances which belong to or are components of one of those categories
other substance means a substance other than a nutrient that has a nutritional or physiological effect;
nutrition claim means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:
(a) the energy (calorific value) it
(i) provides,
(ii) provides at a reduced or increased rate, or
(iii) does not provide; and/or
(b) the nutrients or other substances it
(i) contains,
(ii) contains in reduced or increased proportions, or
(iii) does not contain
health claim means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health
reduction of disease risk claim means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease
Authority means the European Food Safety Authority established by Regulation (EC) No 178/2002
pack means a wrapping containing Class A or B eggs, excluding transport packaging and containers of industrial eggs
loose sales means the offer for retail sale of eggs to the final consumer, other than in packs
collector means any establishment registered in accordance with Article 6 of Regulation (EC) No 852/2004 to collect eggs from a producer for delivery to a packing centre, to a market selling exclusively to wholesalers whose undertakings are approved as packing centres, or to the food or non-food industry
sell-by date means the maximum time limit for delivery of the egg to the final consumer according to point 3 of Chapter I of Section X of Annex III to Regulation (EC) No 853/2004
food industry means any establishment producing egg products intended for human consumption, excluding mass caterers
non-food industry means any business producing products containing eggs not intended for human consumption
mass caterers means the entities referred to in Article 1(2) of Directive 2000/13/EC
industrial eggs means eggs not intended for human consumption
batch means the eggs in packs or loose from one and the same production site or packing centre, situated in one place, in the same packs or loose, with one and the same laying date or date of minimum durability or packing date, the same farming method, and in the case of graded eggs, the same quality and weight grading
repacking means the physical transfer of eggs to another pack or the re-marking of a pack containing eggs
eggs means eggs in shell — other than broken, incubated or cooked eggs — that are produced by hens of the species Gallus gallus and are fit for direct human consumption or for the preparation of egg products
broken eggs means eggs showing breaks of both the shell and the membranes, resulting in the exposure of their contents
incubated eggs means eggs from the time of insertion in the incubator onwards
marketing means holding eggs for the purpose of sale, including offering for sale, storage, packing, labelling, delivery, or any other form of transfer, whether free of charge or not
operator means a producer and any other natural or legal person involved in the marketing of eggs
production site means an establishment keeping laying hens, registered in accordance with Commission Directive 2002/4/EC
packing centre means a packing centre within the meaning of Regulation (EC) No 853/2004 that is authorised according to Article 5(2) of this Regulation and where eggs are graded by quality and weight
final consumer means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity
producer code means the distinguishing number of the production site according to point 2 of the Annex to Directive 2002/4/EC
alien species means any live specimen of a species, subspecies or lower taxon of animals, plants, fungi or micro-organisms introduced outside its natural range; it includes any part, gametes, seeds, eggs or propagules of such species, as well as any hybrids, varieties or breeds that might survive and subsequently reproduce
invasive alien species means an alien species whose introduction or spread has been found to threaten or adversely impact upon biodiversity and related ecosystem services
invasive alien species of Union concern means an invasive alien species whose adverse impact has been deemed such as to require concerted action at Union level pursuant to Article 4(3)
invasive alien species of Member State concern means an invasive alien species other than an invasive alien species of Union concern, for which a Member State considers on the basis of scientific evidence that the adverse impact of its release and spread, even where not fully ascertained, is of significance for its territory, or part of it, and requires action at the level of that Member State
biodiversity means the variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems
ecosystem services means the direct and indirect contributions of ecosystems to human wellbeing
introduction means the movement, as a consequence of human intervention, of a species outside its natural range
research means descriptive or experimental work, undertaken under regulated conditions to obtain new scientific findings or to develop new products, including the initial phases of identification, characterisation and isolation of genetic features, other than those features which make a species invasive, of invasive alien species only insofar as essential to enable the breeding of those features into non-invasive species
contained holding means keeping an organism in closed facilities from which escape or spread is not possible
ex-situ conservation means the conservation of components of biological diversity outside their natural habitat
pathways means the routes and mechanisms of the introduction and spread of invasive alien species
early detection means the confirmation of the presence of a specimen or specimens of an invasive alien species in the environment before it has become widely spread
eradication means the complete and permanent removal of a population of invasive alien species by lethal or non-lethal means
population control means any lethal or non-lethal action applied to a population of invasive alien species, while also minimising the impact on non-targeted species and their habitats, with the aim of keeping the number of individuals as low as possible, so that, while not being able to eradicate the species, its invasive capacity and adverse impact on biodiversity, the related ecosystem services, on human health or the economy, are minimised
containment means any action aimed at creating barriers which minimises the risk of a population of an invasive alien species dispersing and spreading beyond the invaded area
widely spread means an invasive alien species whose population has gone beyond the naturalisation stage, in which a population is self-sustaining, and has spread to colonise a large part of the potential range where it can survive and reproduce
management means any lethal or non-lethal action aimed at the eradication, population control or containment of a population of an invasive alien species, while also minimising the impact on non-targeted species and their habitats
accident at work means a discrete occurrence in the course of work which leads to physical or mental harm. The phrase ‘in the course of work’ means whilst engaged in an occupational activity or during the time spent at work. This includes road traffic accidents that occur in the course of work but excludes commuting accidents, i.e. road accidents that occur during the journey between home and the workplace
a fatal accident means an accident which leads to the death of a victim within 1 year of the accident
economic activity of the employer covers the main ‘economic’ activity of the local unit of the enterprise of the victim
age means the age of the victim at the time of the accident
type of injury means the physical consequences for the victim
geographical location means the territorial unit where the accident has occurred
size of the enterprise means the number of employees (full-time equivalent) working at the local unit of the enterprise of the victim
nationality of the victim means the country of citizenship
days lost means the number of calendar days during which the victim is unfit for work as a result of an accident at work
workstation means the usual or, alternatively, occasional nature of the place/post occupied by the victim at the time of the accident
working environment means the workplace, work premises or general environment where the accident happened
working process means the main type of work or task (general activity) being performed by the victim at the time of the accident
specific physical activity means the victim’s exact physical activity at the instant of the accident
material agent associated with the specific physical activity means the tool, object or instrument being used by the victim when the accident happened
deviation means the last event deviating from normality and leading to the accident
material agent associated with the deviation means the tool, object or instrument involved in the abnormal event
contact — mode of injury means how the victim was hurt (physical or mental trauma) by the material agent that caused the injury
material agent associated with the contact — mode of injury means the object, tool or instrument with which the victim came into contact or the psychological mode of injury
public health shall mean all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality
health and safety at work shall mean all elements related to the prevention and protection of the health and safety of workers at work in their current or past activities, in particular accidents at work, occupational diseases and other work-related health problems and illnesses
microdata shall mean individual statistical records
transmission of confidential data shall mean transmission between national authorities and the Community authority of confidential data which do not permit direct identification, in accordance with Article 14 of Regulation (EC) No 322/97 and with Regulation (Euratom, EEC) No 1588/90
personal data shall mean any information relating to an identified or identifiable natural person, in accordance with the Article 2(a) of Directive 95/46/EC
navigable inland waterway means a watercourse, not part of the sea, which by natural or man-made features is suitable for navigation, primarily by inland waterway vessels
inland waterway vessel means a floating craft designed for the carriage of goods or public transport of passengers which navigates predominantly in navigable inland waterways or in waters within, or closely adjacent to sheltered waters or areas where port regulations apply
nationality of the vessel means the country where the vessel is registered
inland waterways transport means any movement of goods and/or passengers using inland waterways vessels which is undertaken wholly or partly in navigable inland waterways
national inland waterways transport means inland waterways transport between two ports of a national territory irrespective of the nationality of the vessel
international inland waterways transport means inland waterways transport between two ports located in different national territories
transit inland waterways transport means inland waterways transport through a national territory between two ports both located in another national territory or national territories provided that in the total journey within the national territory there is no transshipment
inland waterways traffic means any movement of a vessel on a given navigable inland waterway
carriage of goods and passengers by sea means the movement of goods and passengers using seagoing vessels, on voyages which are undertaken wholly or partly at sea.
The scope of this Directive shall also include goods:
(i) shipped to offshore installations;
(ii) reclaimed from the seabed and unloaded in ports.
Bunkers and stores supplied to vessels shall be excluded from the scope of this Directive
seagoing vessels means vessels other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply.
This Directive shall not apply to fish-catching vessels, fish-processing vessels, vessels for drilling and exploration, tugs, pusher craft, research and survey vessels, dredgers, naval vessels or vessels used solely for non-commercial purposes
port means a place having facilities for merchant ships to moor and to load or unload cargo or to disembark or embark passengers to or from vessels
nationality of the maritime transport operator means that corresponding to the country in which the effective centre of the transport operator’s commercial activity is located
maritime transport operator means any person by whom or on behalf of whom a contract for the transport of goods or persons by sea is concluded with a shipper or a passenger
Freight container means an article of transport equipment:
1. of a permanent nature and, accordingly, strong enough to be suitable for repeated use;
2. specially designed to facilitate the carriage of goods by one or more modes of transport, without intermediate reloading;
3. fitted with devices permitting its ease of handling, particularly its transfer from one mode of transport to another;
4. so designed as to be easy to fill and empty;
5. having a length of 20 feet or more
Ro-Ro unit means wheeled equipment for carrying cargo, such as a truck, trailer or semi-trailer, which can be driven or towed on to a vessel. Port or ships’ trailers are included in this definition. Classifications should follow United Nations ECE Recommendation No 21 “Codes for types of cargo, packages and packaging materials”
Container cargo means containers with or without cargo which are lifted on to or off the vessels which carry them by sea
Ro-Ro cargo means goods, whether or not in containers, on Ro-Ro units, and Ro-Ro units which are rolled on and off the vessels which carry them by sea
Gross weight of goods means the tonnage of goods carried, including packaging but excluding the tare weight of containers or Ro-Ro units
Deadweight (DWT) means the difference in tonnes between the displacement of a ship on summer load-line in water with a specific gravity of 1,025 and the total weight of the ship, i.e. the displacement in tonnes of a ship without cargo, fuel, lubricating oil, ballast water, fresh water and drinking water in the tanks, usable supplies as well as passengers, crew and their possessions
Gross tonnage means the measure of the overall size of a ship determined in accordance with the provisions of the International Convention on Tonnage Measurement of Ships, 1969
Cruise passenger means a sea passenger making a sea journey on a cruise ship. Passengers on day excursions are excluded
Cruise ship means a passenger ship intended to provide passengers with a full tourist experience. All passengers have cabins. Facilities for entertainment aboard are included. Ships operating normal ferry services are excluded, even if some passengers treat the service as a cruise. In addition, cargo-carrying vessels able to carry a very limited number of passengers with their own cabins are also excluded. Ships intended solely for day excursions are also excluded
Cruise passenger excursion means a short visit by a cruise passenger to a tourist attraction associated with a port while retaining a cabin on board
Ro-Ro container cargo means containers with or without cargo loaded on Ro-Ro units which are then rolled on and rolled off the vessels which carry them by sea
Shipborne port-to-port trailer means a trailer intended to carry cargo (including containers) between two ports on Ro-Ro vessels. It is primarily designed to operate either on board of Ro-Ro vessels or in areas on land within the control of the port authority
Ro-Ro vessel means a vessel designed to carry Ro-Ro units
carriage of goods by road all transport of goods by means of a goods road transport vehicle
road transport vehicle a road vehicle fitted with an engine whence it derives its sole means of propulsion, which is normally used for carrying persons or goods by road, or for drawing, on the road, vehicles used for the carriage of persons or goods
road vehicle for the transport of goods a road vehicle designed exclusively or primarily to carry goods (lorry, trailer, semi-trailer)
goods road transport vehicle any single road transport vehicle, or combination of road vehicles, namely road train or articulated vehicle, designed to carry goods
lorry a rigid road vehicle designed exclusively or primarily to carry goods
road tractor a road transport vehicle designed exclusively or primarily to haul other road vehicles which are not power-driven (mainly semi-trailers)
trailer a road vehicle for the transport of goods designed to be hauled by a road transport vehicle
semi-trailer a road vehicle for the transport of goods with no front axle so designed that part of the vehicle and a substantial part of its loaded weight rest on the road tractor
articulated vehicle a road tractor coupled to a semi-trailer
road train a goods road transport vehicle coupled to a trailer or an articulated vehicle with a further trailer attached
registered the state of having been entered in a register of road transport vehicles, kept by an official body in a Member State, whether or not the registration is accompanied by the issue of a registration plate.
In the case of carriage by means of a combination of road transport vehicles, namely road train or articulated vehicle, in which the goods road transport vehicle and the trailer or semi-trailer are registered in different countries, the complete vehicle shall be deemed to be registered in the country where the goods road transport vehicle is registered
load capacity maximum weight of goods declared permissible by the competent authority of the country of registration of the vehicle.
When the goods road transport vehicle is a road train made up of a lorry with trailer, the load capacity of the road train is the sum of the load capacities of the lorry and the trailer
maximum permissible weight total weight of the vehicle (or vehicle combination) when stationary and ready for the road and of the weight of the load declared permissible by the competent authority of the country of registration of the vehicle
Eurostat the Commission department responsible for carrying out the tasks incumbent on the Commission in the field of the production of Union statistics
area treated means the basic area treated, defined as ‘the physical area of the crop treated at least once with a given active substance, independently of the number of applications’
active steps to find a suitable candidate shall include:
(i) notifying the job vacancy to the public employment services;
(ii) contacting a private employment agency/head hunters;
(iii) advertising the vacancy in the media (for example internet, newspapers, magazines);
(iv) advertising the vacancy on a public notice board;
(v) approaching, interviewing or selecting possible candidates/potential recruits directly;
(vi) approaching employees and/or personal contacts;
(vii) using internships
specific period of time shall refer to the maximum time the vacancy is open and intended to be filled. That period shall be unlimited; all vacancies for which active steps are continuing on the reference date shall be reported
mobile communication services on board vessels (MCV services) means electronic communication services, as defined in Article 2(c) of Directive 2002/21/EC of the European Parliament and of the Council, provided by an undertaking to enable persons on board a vessel to communicate via public communication networks using a system subject to Article 3 without establishing direct connections with land-based mobile networks
the 900 MHz band means the 880-915 MHz band for uplink (terminal transmit, base station receive) and 925-960 MHz band for downlink (base station transmit, terminal receive)
the 1 800 MHz band means the 1 710-1 785 MHz band for uplink (terminal transmit, base station receive) and 1 805-1 880 MHz band for downlink (base station transmit, terminal receive)
GSM system means an electronic communications network, that complies with the GSM standards, as published by European Telecommunications Standards Institute, in particular EN 301 502 and EN 301 511
on a non-interference and non-protected basis means that no harmful interference may be caused to any radio-communication service and that no claim may be made for protection of these services against harmful interference originating from other radio-communication services
territorial sea is to be understood in the meaning of the United Nations Convention on the Law of the Sea
vessel base transceiver station (vessel-BS) means a mobile pico-cell located on a vessel and supporting GSM, LTE or UMTS services in compliance with the Annex to this Decision
the 1 900 /2 100 MHz bands means the 1 920 -1 980 MHz band for uplink (terminal transmit, base station receive) and 2 110 -2 170 MHz band for downlink (base station transmit, terminal receive)
the 2 600 MHz band means the 2 500 -2 570 MHz band for uplink (terminal transmit, base station receive) and 2 620 -2 690 MHz band for downlink (base station transmit, terminal receive)
LTE system means an electronic communications network as defined in the Annex to Commission Implementing Decision 2011/251/EU
total population of a well-defined geographical area means all persons whose usual residence, as defined in Article 2(d) of Regulation (EC) No 763/2008, is located in that geographical area
hypercube means a multidimensional cross tabulation of breakdowns which contains a cell value for the measurement of each category of each breakdown cross-tabulated by each category of any other breakdown used in that hypercube
cell value means the information provided in a hypercube cell. A cell value can be either a ‘numerical cell value’ or a ‘special cell value’
numerical cell value means a numerical value that is transmitted in a cell in order to provide the statistical information on the observation for that cell
confidential cell value means a numerical cell value which in order to protect the statistical confidentiality of the data must not be divulged, according to the Member States' protective measures against disclosure of statistical data
non-confidential cell value means a numerical cell value which is not a confidential cell value
unreliable cell value means a numerical cell value which is unreliable according to the Member States' quality control
special cell value means a symbol that is transmitted in a hypercube cell instead of a numerical cell value
flag means a code that can accompany a particular cell value to describe a specific characteristic of that cell value
Current activity status is the current relationship of a person to economic activity, based on a reference period of one week, which may be either a specified, recent, fixed, calendar week, or the last complete calendar week, or the last seven days prior to enumeration
labour force comprises all persons who fulfil the requirements for inclusion among the employed or the unemployed
‘Employed’ persons comprise all persons aged 15 years or over who during the reference week:
(a) performed at least one hour of work for pay or profit, in cash or in kind, or
(b) were temporarily absent from a job in which they had already worked and to which they maintained a formal attachment, or from a self-employment activity.
Employees temporarily not at work shall be considered as in paid employment provided they had a formal job attachment. The possible reasons for such temporary absences are:
(a) illness or injury; or
(b) holiday or vacation; or
(c) strike or lock-out; or
(d) educational or training leave; or
(e) maternity or parental leave; or
(f) reduction in economic activity; or
(g) temporary disorganization or suspension of work due to such reasons as bad weather, mechanical or electrical breakdown, or shortage of raw materials or fuels; or
(h) other temporary absence with or without leave.
The formal job attachment shall be determined on the basis of one or more of the following criteria:
(a) a continued receipt of wage or salary; or
(b) an assurance of return to work following the end of the contingency, or an agreement as to the date of return; or
(c) the elapsed duration of absence from the job which, wherever relevant, may be that duration for which workers can receive compensation benefits without obligations to accept other jobs.
Self-employed persons shall be considered as ‘employed’ if they have worked as such during the reference week or if they are temporarily absent from work and their enterprise meanwhile continues to exist.
Contributing family workers shall be considered to be ‘employed’ at work on the same basis as other employed persons; that is irrespective of the number of hours worked during the reference period. Similarly, persons who perform tasks or duties of an employee job held by a family member living in the same, or in another, household shall also be classified as employed.
unemployed comprise all persons aged 15 years or over who were:
(a) ‘without work’, that is, were not in wage employment or self-employment during the reference week; and
(b) ‘currently available for work’, that is, were available for wage employment or self-employment during the reference week and for two weeks after that; and
(c) ‘seeking work’, that is, had taken specific steps to seek wage employment or self-employment within four weeks ending with the reference week
Occupation refers to the type of work done in a job. ‘Type of work’ is described by the main tasks and duties of the work.
The allocation of a person within the breakdowns of the topics ‘Occupation’, ‘Industry’ and ‘Status in employment’ shall be based on the same job. Persons doing more than one job shall be allocated an occupation based on their main job, which is to be identified according to:
(1) the time spent on the job or, if not available,
(2) the income received
Industry (branch of economic activity) refers to the kind of production or activity of the establishment or similar unit in which the job of an employed person is located. For persons who are recruited and employed by one enterprise but who actually have their place of work in another enterprise (‘agency workers’, ‘seconded workers’) the industry (branch of economic activity) of the establishment or similar unit where the place of work actually is shall be reported.
The allocation of a person within the breakdowns of the topics ‘Occupation’, ‘Industry’ and ‘Status in employment’ shall be based on the same job. Persons doing more than one job shall be allocated an industry (branch of economic activity) based on their main job which is to be identified according to:
— the time spent on the job or, if not available,
— the income received
employee is a person who works in a ‘paid employment’ job, that is a job where the explicit or implicit contract of employment gives the incumbent a basic remuneration, which is independent of the revenue of the unit for which he/she works (this unit may be a corporation, a non-profit institution, government unit or a household). Persons in ‘paid employment’ jobs are typically remunerated by wages and salaries, but may be paid by commission from sales, by piece rates, bonuses or in-kind payment such as food, housing or training. Some or all of the tools, capital equipment, information systems and/or premises used by the incumbent may be owned by others, and the incumbent may work under direct supervision of, or according to strict guidelines set by, the owner(s) or persons in the owner's employment
employer is a person who, working on his or her own account or with a small number of partners, holds a ‘self-employment’ job and, in this capacity, on a continuous basis (including the reference week) has engaged one or more persons to work for him/her as ‘employees’. The incumbent makes the operational decisions affecting the enterprise, or delegates such decisions while retaining responsibility for the welfare of the enterprise.
If a person is both employer and employee, he/she shall be allocated to only one group according to:
— the time spent on the job or, if not available,
— the income received
own-account worker is a person who, working on his/her own account or with one or a few partners, holds a ‘self-employment job’ and has not engaged, on a continuous basis (including the reference week), any ‘employees’
contributing family worker is a person who
— holds a ‘self-employment’ job in a market-oriented establishment operated by a related person, living in the same household, and
— cannot be regarded as a partner (that is an employer or own-account worker) because the degree of commitment to the operation of the establishment, in terms of working time or other factors to be determined by national circumstances, is not at a level comparable to that of the head of the establishment
member of a producers’ cooperative is a person who holds a ‘self-employment’ job in an establishment organised as a cooperative, in which each member takes part on an equal footing with other members in determining the organisation of production, sales and/or other work, the investments and the distribution of the proceeds among the members
partners shall include married couples, couples in registered partnerships, and couples who live in a consensual union
Skip-generation households households consisting of a grandparent or grandparents and one or more grandchildren, but no parent of those grandchildren
Homeless persons are persons living in the streets without a shelter that would fall within the scope of living quarters (primary homelessness) or persons moving frequently between temporary accommodation (secondary homelessness)
Couple households shall include married couple households, registered partnership households and consensual union couple households
Occupants are persons with their usual residence in the places listed in the respective category
Conventional dwellings are structurally separate and independent premises at fixed locations which are designed for permanent human habitation and are, at the reference date,
(a) used as a residence, or
(b) vacant, or
(c) reserved for seasonal or secondary use
Separate means surrounded by walls and covered by a roof or ceiling so that one or more persons can isolate themselves
Independent means having direct access from a street or a staircase, passage, gallery or grounds
Other housing units are huts, cabins, shacks, shanties, caravans, houseboats, barns, mills, caves or any other shelter used for human habitation at the time of the census, irrespective if it was designed for human habitation
Collective living quarters are premises which are designed for habitation by large groups of individuals or several households and which are used as the usual residence of at least one person at the time of the census
Occupied conventional dwellings are conventional dwellings which are the usual residence of one or more persons at the time of the census
Unoccupied conventional dwellings are conventional dwellings which are not the usual residence of any person at the time of the census
Owner-occupied dwellings are those where at least one occupant of the dwelling owns parts or the whole of the dwelling
Rented dwellings are those where at least one occupant pays a rent for the occupation of the dwelling, and where no occupant owns parts or the whole of the dwelling
room is defined as a space in a housing unit enclosed by walls reaching from the floor to the ceiling or roof, of a size large enough to hold a bed for an adult (4 square metres at least) and at least 2 metres high over the major area of the ceiling
social protection all interventions from public or private bodies intended to relieve households and individuals of the burden of a defined set of risks or needs, provided that neither a simultaneous reciprocal arrangement nor an individual arrangement is involved. The list of risks or needs that may give rise to social protection is, by convention, as follows: sickness and/or health care; disability; old age; survivorship; family/children; unemployment; housing; and social exclusion not elsewhere classified
social protection scheme a distinct body of rules, supported by one or more institutional units, governing the provision of social protection benefits and their financing
social protection benefits transfers, in cash or in kind, by social protection schemes to households and individuals to relieve them of the burden of one or more of the defined risks or needs
fiscal benefits social protection provided in the form of tax breaks that would be defined as social protection benefits if they were provided in cash, excluding tax breaks promoting the provision of social protection or promoting private insurance plans
net social protection benefits the value of social protection benefits excluding taxes and social contributions paid by the benefits' recipients complemented by the value of fiscal benefits
GSM system means an electronic communications network as specified by ETSI standards, in particular EN 301 502, EN 301 511, and EN 301 908-18, also including Extended Coverage GSM IoT (EC-GSM-IoT)
900 MHz band means the 880-915 MHz and 925-960 MHz bands
1 800 MHz band means the 1 710-1 785 MHz and 1 805-1 880 MHz bands
multinational enterprise group shall mean an enterprise group which has at least two enterprises or legal units located in different countries
truncated enterprise group shall mean the enterprises and the legal units of a multinational enterprise group, which are resident in the same country. It may comprise only one unit, if the other units are non-resident. An enterprise may be the truncated enterprise group or part thereof
wireless audio PMSE equipment means radio equipment used for transmission of analogue or digital audio signals between a limited number of transmitters and receivers, such as radio microphones, in-ear monitor systems or audio links, used mainly for the production of broadcast programmes or private or public social or cultural events
public protection and disaster relief (PPDR) radio communications means radio applications used for public safety, security and defence used by national authorities or relevant operators responding to the relevant national needs in regard to public safety and security including in emergency situations
machine-to-machine (M2M) radio communications means radio links for the purpose of relaying information between physical or virtual entities that build a complex ecosystem including the internet of Things; such radio links may be realised through electronic communications services (e.g. based on cellular technologies) or other services, based on licensed or unlicensed use of spectrum
public passenger transport means passenger transport services of general economic interest provided to the public on a non-discriminatory and continuous basis
competent authority means any public authority or group of public authorities of a Member State or Member States which has the power to intervene in public passenger transport in a given geographical area or any body vested with such authority
competent local authority means any competent authority whose geographical area of competence is not national
public service operator means any public or private undertaking or group of such undertakings which operates public passenger transport services or any public body which provides public passenger transport services
public service obligation means a requirement defined or determined by a competent authority in order to ensure public passenger transport services in the general interest that an operator, if it were considering its own commercial interests, would not assume or would not assume to the same extent or under the same conditions without reward
exclusive right means a right entitling a public service operator to operate certain public passenger transport services on a particular route or network or in a particular area, to the exclusion of any other such operator
public service compensation means any benefit, particularly financial, granted directly or indirectly by a competent authority from public funds during the period of implementation of a public service obligation or in connection with that period
direct award means the award of a public service contract to a given public service operator without any prior competitive tendering procedure
public service contract means one or more legally binding acts confirming the agreement between a competent authority and a public service operator to entrust to that public service operator the management and operation of public passenger transport services subject to public service obligations; depending on the law of the Member State, the contract may also consist of a decision adopted by the competent authority:
— taking the form of an individual legislative or regulatory act, or
— containing conditions under which the competent authority itself provides the services or entrusts the provision of such services to an internal operator
internal operator means a legally distinct entity over which a competent local authority, or in the case of a group of authorities at least one competent local authority, exercises control similar to that exercised over its own departments
value means the value of a service, a route, a public service contract, or a compensation scheme for public passenger transport corresponding to the total remuneration, before VAT, of the public service operator or operators, including compensation of whatever kind paid by the public authorities and revenue from the sale of tickets which is not repaid to the competent authority in question
general rule means a measure which applies without discrimination to all public passenger transport services of the same type in a given geographical area for which a competent authority is responsible
integrated public passenger transport services means interconnected transport services within a determined geographical area with a single information service, ticketing scheme and timetable
public passenger transport services by rail means public passenger transport by rail, excluding passenger transport by other track-based modes, such as metros or tramways
research and innovation activities mean the whole spectrum of activities of research, technological development, demonstration and innovation, including the promotion of cooperation with third countries and international organisations, the dissemination and optimisation of results and the stimulation of high quality training and mobility of researchers in the Union
direct actions mean research and innovation activities undertaken by the Commission through its Joint Research Centre (JRC)
indirect actions mean research and innovation activities to which the Union provides financial support and which are undertaken by participants
public-private partnership means a partnership where private sector partners, the Union and, where appropriate, other partners, such as public sector bodies, commit to jointly support the development and implementation of a research and innovation programme or activities
public-public partnership means a partnership where public sector bodies or bodies with a public service mission at local, regional, national or international level commit with the Union to jointly support the development and implementation of a research and innovation programme or activities
research infrastructures mean facilities, resources and services that are used by the research communities to conduct research and foster innovation in their fields. Where relevant, they may be used beyond research, for example for education or public services. They include major scientific equipment or sets of instruments; knowledge-based resources such as collections, archives or scientific data; e-infrastructures such as data and computing systems and communication networks; and any other infrastructure of a unique nature essential to achieving excellence in research and innovation. Such infrastructures may be 'single-sited', 'virtual' or 'distributed'
smart specialisation strategy has the same meaning as smart specialisation strategy as defined in point (3) of Article 2 of Regulation (EU) No 1303/2013 of the European Parliament and of the Council
GMES service information means information and its metadata produced by GMES services
GMES dedicated data means data collected through the GMES dedicated infrastructure and their metadata
metadata means structured information on data or information allowing their discovery, inventory and use
GMES dissemination platform means technical systems used to disseminate GMES dedicated data and GMES service information to users
vehicle means any not rail-borne motor vehicle or its trailer
motor vehicle means any power-driven vehicle on wheels which is moved by its own means with a maximum design speed exceeding 25 km/h
trailer means any non-self propelled vehicle on wheels which is designed and constructed to be towed by a motor vehicle
semi-trailer means any trailer designed to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle and a substantial part of its mass and the mass of its load is borne by the motor vehicle
two- or three-wheel vehicle means any power-driven vehicle on two wheels, with or without a sidecar, and any tricycle or quadricycle
vehicle registered in a Member State means a vehicle which is registered or put into service in a Member State
vehicle of historical interest means any vehicle which is considered to be historical by the Member State of registration or one of its appointed authorising bodies and which fulfils all the following conditions:
— it was manufactured or registered for the first time at least 30 years ago;
— its specific type, as defined in the relevant Union or national law, is no longer in production;
— it is historically preserved and maintained in its original state and has not undergone substantial changes in the technical characteristics of its main components
holder of a registration certificate means the legal or natural person in whose name the vehicle is registered
roadworthiness test means an inspection in accordance with Annex I designed to ensure that a vehicle is safe to be used on public roads and that it complies with required and mandatory safety and environmental characteristics
approval means a procedure whereby a Member State certifies that a vehicle satisfies the relevant administrative provisions and technical requirements referred to in Directive 2002/24/EC, Directive 2003/37/EC and Directive 2007/46/EC
deficiencies means technical defects and other instances of non-compliance found during a roadworthiness test
roadworthiness certificate means a roadworthiness test report issued by the competent authority or a testing centre containing the result of the roadworthiness test
inspector means a person authorised by a Member State or by its competent authority to carry out roadworthiness tests in a testing centre or, where appropriate, on behalf of a competent authority
competent authority means an authority or public body entrusted by a Member State with responsibility for managing the system of roadworthiness testing, including, where appropriate, the carrying-out of roadworthiness tests
testing centre means a public or private body or establishment authorised by a Member State to carry out roadworthiness tests
supervising body means a body or bodies set up by a Member State, responsible for the supervision of testing centres. A supervising body can be part of the competent authority or competent authorities
small island means an island with fewer than 5 000 inhabitants which is not linked to the other parts of territory by road bridges or road tunnels
sparsely populated area means a predefined area with a population density of fewer than five persons per square kilometre
public road means a road that is of general public utility, such as a local, regional or national road, highway, expressway or motorway
parcel means a postal item containing goods with or without commercial value, other than an item of correspondence, with a weight not exceeding 31,5 kg
parcel delivery services means services involving the clearance, sorting, transport and distribution of parcels
parcel delivery service provider means an undertaking that provides one or more parcel delivery services with the exception of undertakings established in one Member State alone, that only provide domestic parcel delivery services as part of a sales contract and as part of the contract personally deliver goods that are subject of that contract to the user
subcontractor means an undertaking that provides the clearance, sorting, transport or distribution of parcels for the parcel delivery service provider
access rights means rights to use results or background under the terms and conditions laid down in accordance with this Regulation
affiliated entity means any legal entity that is under the direct or indirect control of a participant, or under the same direct or indirect control as the participant, or that is directly or indirectly controlling a participant. Control may take any of the forms set out in Article 8(2)
associated country means a third country which is party to an international agreement with the Union, as identified in Article 7 of Regulation (EU) No 1291/2013
background means any data, know-how or information whatever its form or nature, tangible or intangible, including any rights such as intellectual property rights, which is: (i) held by participants prior to their accession to the action; (ii) needed for carrying out the action or for exploiting the results of the action; and (iii) identified by the participants in accordance with Article 45
basic act means a legal act adopted by the Union institutions in the form of a regulation, a directive or a decision within the meaning of Article 288 TFEU which provides a legal basis for the action
innovation action means an action primarily consisting of activities directly aimed at producing plans and arrangements or designs for new, altered or improved products, processes or services. For this purpose they may include prototyping, testing, demonstrating, piloting, large-scale product validation and market replication
coordination and support action means an action consisting primarily of accompanying measures such as standardisation, dissemination, awareness-raising and communication, networking, coordination or support services, policy dialogues and mutual learning exercises and studies, including design studies for new infrastructure, and may also include complementary activities of networking and coordination between programmes in different countries
dissemination means the public disclosure of the results by any appropriate means (other than resulting from protecting or exploiting the results), including by scientific publications in any medium
exploitation means the use of results in further research activities other than those covered by the action concerned, or in developing, creating and marketing a product or process, or in creating and providing a service, or in standardisation activities
fair and reasonable conditions means appropriate conditions, including possible financial terms or royalty-free conditions, taking into account the specific circumstances of the request for access, for example the actual or potential value of the results or background to which access is requested and/or the scope, duration or other characteristics of the exploitation envisaged
funding body means a body or authority, other than the Commission, as referred to in point (c) of Article 58(1) of Regulation (EU, Euratom) No 966/2012, to which the Commission has entrusted budget implementation tasks in accordance with Article 9(2) of Regulation (EU) No 1291/2013
international European interest organisation means an international organisation, the majority of whose members are Member States or associated countries, and whose principal objective is to promote scientific and technological cooperation in Europe
legal entity means any natural person, or any legal person created and recognised as such under national law, Union law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations
non-profit legal entity means a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members
participant means any legal entity carrying out an action or part of an action under Regulation (EU) No 1291/2013 having rights and obligations with regard to the Union or another funding body under this Regulation
programme co-fund action means an action funded through a grant the main purpose of which is supplementing individual calls or programmes funded by entities, other than Union funding bodies, managing research and innovation programmes. A programme co-fund action may also include complementary activities of networking and coordination between programmes in different countries
pre-commercial procurement means the procurement of research and development services involving risk-benefit sharing under market conditions, and competitive development in phases, where there is a clear separation of the research and development services procured from the deployment of commercial volumes of end-products
public procurement of innovative solutions means procurement where contracting authorities act as a launch customer for innovative goods or services which are not yet available on a large-scale commercial basis, and may include conformity testing
results means any tangible or intangible output of the action, such as data, knowledge or information, that is generated in the action, whatever its form or nature, whether or not it can be protected, as well as any rights attached to it, including intellectual property rights
work programme means the document adopted by the Commission for the implementation of the specific programme in accordance with Article 5 of Council Decision 2013/743/EU of 3 December 2013
work plan means the document similar to the Commission work programme adopted by funding bodies entrusted with part of the implementation of Horizon 2020 in accordance with Article 9(2) of Regulation (EU) No 1291/2013
defence service provider means a legal entity with a legal or contractual obligation to provide a service contributing to one or several measures of the system defence plan
restoration service provider means a legal entity with a legal or contractual obligation to provide a service contributing to one or several measures of the restoration plan
high priority significant grid user means the significant grid user for which special conditions apply for disconnection and re-energisation
netted demand means the netted value of active power seen from a given point of the system, computed as (load — generation), generally expressed in kilowatts (kW) or megawatts (MW), at a given instant or averaged over any designated interval of time
restoration plan means all technical and organisational measures necessary for the restoration of the system back to normal state
re-energisation means reconnecting generation and load to energise the parts of the system that have been disconnected
top-down re-energisation strategy means a strategy that requires the assistance of other TSOs to re-energise parts of the system of a TSO
bottom-up re-energisation strategy means a strategy where part of the system of a TSO can be re-energised without the assistance from other TSOs
resynchronisation means synchronising and connecting again two synchronised regions at the resynchronisation point
frequency leader means the TSO appointed and responsible for managing the system frequency within a synchronised region or a synchronous area in order to restore system frequency back to the nominal frequency
synchronised region means the fraction of a synchronous area covered by interconnected TSOs with a common system frequency and which is not synchronised with the rest of the synchronous area
resynchronisation leader means the TSO appointed and responsible for the resynchronisation of two synchronised regions
resynchronisation point means the device used to connect two synchronised regions, usually a circuit breaker
inspection means the standardisation inspection referred to in Article 24(1) and Article 54 of Regulation (EC) No 216/2008, including the inspection of undertakings or associations of undertakings referred to in Article 54(4) and Article 55 of that Regulation, carried out by the Agency
competent authority means the entity designated by the Member State as competent for the implementation of Regulation (EC) No 216/2008 and its implementing rules
authorised personnel means the persons authorised by the Agency to carry out inspections, including seconded personnel
seconded personnel means the officials made available by the competent authorities of Member States, the International Civil Aviation Organisation (ICAO), other international aviation organisations or the competent authorities of Third Countries having agreements with the Union or working arrangements with the Agency, who are nominated by these authorities to assist the Agency in carrying out inspections
evidence means records, statements of fact, or other information which are relevant and verifiable
finding means the result of the comparison between the available evidence and the applicable requirements
correction means an action to eliminate a finding of non-conformity with the applicable requirements
corrective action means an action to eliminate the cause of a finding of non-conformity with the applicable requirements in order to prevent recurrence
immediate safety concern means a situation where there is evidence that a product, service, system, constituent, equipment or facility is either in such a condition, or is being operated, supplied or maintained in such a manner that harm to persons is likely to occur unless the situation is corrected immediately
non-Union scheme means the special scheme for telecommunications services, broadcasting services or electronic services supplied by taxable persons not established within the Community provided for in Section 2 of Chapter 6 of Title XII of Directive 2006/112/EC
Union scheme means the special scheme for telecommunications services, broadcasting services or electronic services supplied by taxable persons established within the Community but not established in the Member State of consumption provided for in Section 3 of Chapter 6 of Title XII of Directive 2006/112/EC
special scheme means the ‘non-Union scheme’ and/or the ‘Union scheme’ as the context requires
taxable person means a taxable person not established within the Community as defined in point (1) of Article 358a of Directive 2006/112/EC, or a taxable person not established in the Member State of consumption, as defined in point (1) of the first paragraph of Article 369a of that Directive
fixed establishment shall be any establishment, other than the place of establishment of a business referred to in Article 10 of this Regulation, characterised by a sufficient degree of permanence and a suitable structure in terms of human and technical resources to enable it to receive and use the services supplied to it for its own needs
fixed establishment shall be any establishment, other than the place of establishment of a business referred to in Article 10 of this Regulation, characterised by a sufficient degree of permanence and a suitable structure in terms of human and technical resources to enable it to provide the services which it supplies
Protocol means the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer, as last amended and adjusted
State not party to the Protocol means, with respect to a particular controlled substance, any State or regional economic integration organisation that has not agreed to be bound by the provisions of the Protocol applicable to that substance
controlled substances means substances listed in Annex I, including their isomers, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed
chlorofluorocarbons means the controlled substances listed in Group I of Annex I, including their isomers
halons means the controlled substances listed in Group III of Annex I, including their isomers
carbon tetrachloride means the controlled substance specified in Group IV of Annex I
methyl bromide means the controlled substance specified in Group VI of Annex I
hydrochlorofluorocarbons means the controlled substances listed in Group VIII of Annex I, including their isomers
new substances means substances listed in Annex II, whether alone or in a mixture, and whether they are virgin, recovered, recycled or reclaimed
feedstock means any controlled substance or new substance that undergoes chemical transformation in a process in which it is entirely converted from its original composition and whose emissions are insignificant
process agents means controlled substances used as chemical process agents in the applications listed in Annex III
producer means any natural or legal person producing controlled substances or new substances within the Community
production means the amount of controlled substances or new substances produced, including the amount produced, intentionally or inadvertently, as a by-product unless that by-product is destroyed as part of the manufacturing process or following a documented procedure ensuring compliance with this Regulation and the Community and national legislation on waste. No amount recovered, recycled or reclaimed shall be considered as ‘production’, nor shall any insignificant amount unavoidably incorporated in products in trace quantities or emitted during manufacturing
ozone-depleting potential or ODP means the figure specified in Annexes I and II representing the potential effect of each controlled substance or new substance on the ozone layer
calculated level means a quantity determined by multiplying the quantity of each controlled substance by its ozone-depleting potential and by adding together, for each group of controlled substances in Annex I separately, the resulting figures
industrial rationalisation means the transfer either between Parties or within a Member State of all or a portion of the calculated level of production of one producer to another, for the purpose of optimising economic efficiency or responding to anticipated shortfalls in supply as a result of plant closures
import means the entry of substances, products and equipment covered by this Regulation into the customs territory of the Community as far as the territory is covered by a Member State’s ratification of the Protocol and this Regulation applies
export means the exit from the customs territory of the Community, in so far as the territory is covered by a Member State’s ratification of the Protocol and by this Regulation, of substances, products and equipment covered by this Regulation which have the status of Community goods or the re-export of substances, products and equipment covered by this Regulation if they have the status of non-Community goods
placing on the market means the supplying or making available to third persons within the Community for payment or free of charge, and includes the release for free circulation in the Community as referred to in Regulation (EC) No 450/2008. In respect of products and equipment being part of immovable property or part of means of transport this refers only to the supplying or making available within the Community for the first time
use means the utilisation of controlled substances or new substances in the production, maintenance or servicing, including refilling, of products and equipment or in other processes
heat pump means a device or installation that extracts heat at low temperatures from air, water or earth and supplies heat
recovery means the collection and the storage of controlled substances from products and equipment or containers during maintenance or servicing or before disposal
recycling means the reuse of a recovered controlled substance following a basic cleaning process
reclamation means the reprocessing of a recovered controlled substance in order to meet the equivalent performance of a virgin substance, taking into account its intended use
undertaking means any natural or legal person which:
(a) produces, recovers, recycles, reclaims, uses or destroys controlled substances or new substances;
(b) imports such substances;
(c) exports such substances;
(d) places such substances on the market; or
(e) operates refrigeration, air conditioning or heat pump equipment, or fire protection systems, which contain controlled substances
quarantine applications means treatments to prevent the introduction, establishment or spread of quarantine pests (including diseases), or to ensure their official control, where:
— official control is that performed by, or authorised by, a national plant, animal or environmental protection or health authority,
— quarantine pests are pests of potential importance to the areas endangered thereby and not yet present there, or present but not widely distributed, and being officially controlled
pre-shipment applications means those non-quarantine applications applied no more than 21 days prior to export to meet the official requirements of the importing country or official requirements of the exporting country existing before 7 December 1995. Official requirements are those which are performed by, or authorised by, a national plant, animal, environmental, health or stored product authority
products and equipment relying on controlled substances means products and equipment which do not function without controlled substances, not including those products and equipment used for the production, processing, recovery, recycling, reclamation or destruction of controlled substances
virgin substances means substances which have not previously been used
products and equipment means all products and equipment except containers used for the transportation or storage of controlled substances
Cut-off date means the date after which halons must not be used for fire extinguishers or fire protection systems in new equipment and new facilities for the application concerned
New equipment means equipment for which, by the cut-off date, neither of the following events has occurred:
(a) signature of the relevant procurement or development contract;
(b) submission of a request for type approval or type certification to the appropriate regulatory authority. or aircraft, submission of a request for type certification refers to a submission of a request for a new aircraft type certification.
New facilities means facilities for which, by the cut-off date, neither of the following events has occurred:
(a) signature of the relevant development contract;
(b) submission of a request for planning consent to the appropriate regulatory authority
End date means the date after which halons shall not be used for the application concerned and by which date the fire extinguishers or fire protection systems containing halons shall be decommissioned
Inerting means preventing the initiation of combustion of a flammable or explosive atmosphere by means of the addition of an inhibiting or diluting agent
Cargo ship means a ship that is not a passenger ship, is over 500 tonnes gross weight, and embarks on an international voyage, in accordance with the definition of those terms in the Safety of Life at Sea (SOLAS) Convention. The SOLAS Convention defines a ‘passenger ship’ as ‘a ship that carries more than 12 passengers’ and an ‘international voyage’ as ‘a voyage from a country to which the present Convention applies to a port outside such country, or conversely’
‘normally occupied’ space means a protected space in which it is necessary for persons to be present most or all of the time in order for the equipment or facility to function effectively. For military applications, the occupancy status of the protected space would be that applicable during a combat situation
‘normally unoccupied’ space means a protected space that is occupied for limited periods only, in particular for undertaking maintenance, and where the continual presence of persons is not necessary for the effective functioning of the equipment or facility
fluorinated greenhouse gases means the hydrofluorocarbons, perfluorocarbons, sulphur hexafluoride and other greenhouse gases that contain fluorine, listed in Annex I, or mixtures containing any of those substances
hydrofluorocarbons or HFCs means the substances listed in section 1 of Annex I, or mixtures containing any of those substances
perfluorocarbons or PFCs means the substances listed in section 2 of Annex I, or mixtures containing any of those substances
sulphur hexafluoride or SF6 means the substance listed in section 3 of Annex I, or mixtures containing that substance
mixture means a fluid composed of two or more substances, at least one of which is a substance listed in Annex I or in Annex II
global warming potential or GWP means the climatic warming potential of a greenhouse gas relative to that of carbon dioxide (‘CO2’), calculated in terms of the 100-year warming potential of one kilogram of a greenhouse gas relative to one kilogram of CO2, as set out in Annexes I, II and IV or in the case of mixtures, calculated in accordance with Annex IV
tonne(s) of CO2 equivalent means a quantity of greenhouse gases„ expressed as the product of the weight of the greenhouse gases in metric tonnes and of their global warming potential
operator means the natural or legal person exercising actual power over the technical functioning of products and equipment covered by this Regulation; a Member State may, in defined, specific situations, designate the owner as being responsible for the operator’s obligations
use means the utilisation of fluorinated greenhouse gases in the production, maintenance or servicing, including the refilling, of products and equipment, or in other processes referred to in this Regulation
placing on the market means supplying or making available to another party in the Union for the first time, for payment or free of charge, or using for its own account in the case of a producer, and includes customs release for free circulation in the Union
hermetically sealed equipment means equipment in which all fluorinated greenhouse gas containing parts are made tight by welding, brazing or a similar permanent connection, which may include capped valves or capped service ports that allow proper repair or disposal, and which have a tested leakage rate of less than 3 grams per year under a pressure of at least a quarter of the maximum allowable pressure
container means a product which is designed primarily for transporting or storing fluorinated greenhouse gases
a non-refillable container means a container which cannot be refilled without being adapted for that purpose or is placed on the market without provision having been made for its return for refilling
recovery means the collection and storage of fluorinated greenhouse gases from products, including containers, and equipment during maintenance or servicing or prior to the disposal of the products or equipment
recycling means the reuse of a recovered fluorinated greenhouse gas following a basic cleaning process
reclamation means the reprocessing of a recovered fluorinated greenhouse gas in order to match the equivalent performance of a virgin substance, taking into account its intended use
destruction means the process of permanently transforming or decomposing all or most of a fluorinated greenhouse gas into one or more stable substances that are not fluorinated greenhouse gases
decommissioning means the final shut-down and removal from operation or usage of a product or piece of equipment containing fluorinated greenhouse gases
repair means the restoration of damaged or leaking products or equipment that contain, or whose functioning relies upon, fluorinated greenhouse gases, involving a part containing or designed to contain such gases
installation means joining two or more pieces of equipment or circuits containing or designed to contain fluorinated greenhouse gases, with a view to assembling a system in the location where it will be operated, that entails joining together gas carrying conductors of a system to complete a circuit irrespective of the need to charge the system after assembly
maintenance or servicing means all activities, excluding recovery in accordance with Article 8 and leak checks in accordance with Article 4 and point (b) of Article 10(1) of this Regulation, that entail breaking into the circuits containing or designed to contain fluorinated greenhouse gases, in particular supplying the system with fluorinated greenhouse gases, removing one or more pieces of circuit or equipment, reassembling two or more pieces of circuit or equipment, as well as repairing leaks
virgin substance means a substance which has not previously been used
stationary means not normally in transit during operation and includes moveable room air-conditioning appliances
mobile means normally in transit during operation
one-component foam means a foam composition contained in a single aerosol dispenser in unreacted or partly reacted liquid state and that expands and hardens when it leaves the dispenser
refrigerated truck means a motor vehicle with a mass of more than 3,5 tonnes that is designed and constructed primarily to carry goods and that is equipped with a refrigeration unit
refrigerated trailer means a vehicle that is designed and constructed to be towed by a truck or a tractor, primarily to carry goods and that is equipped with a refrigeration unit
technical aerosol means an aerosol dispenser used in maintaining, repairing, cleaning, testing, disinsecting and manufacturing products and equipment, installing equipment, and in other applications
leakage detection system means a calibrated mechanical, electrical or electronic device for detecting leakage of fluorinated greenhouse gases which, on detection, alerts the operator
undertaking means any natural or legal person who:
(a) produces, uses, recovers, collects, recycles, reclaims, or destroys fluorinated greenhouse gases;
(b) imports or exports fluorinated greenhouse gases or products and equipment that contain such gases;
(c) places on the market fluorinated greenhouse gases or products and equipment that contain, or whose functioning relies upon, such gases;
(d) installs, services, maintains, repairs, checks for leaks or decommissions equipment that contains, or whose functioning relies upon, fluorinated greenhouse gases;
(e) is the operator of equipment that contains, or whose functioning relies upon, fluorinated greenhouse gases;
(f) produces, imports, exports, places on the market or destroys gases listed in Annex II;
(g) places on the market products or equipment containing gases listed in Annex II
feedstock means any fluorinated greenhouse gas, or substance listed in Annex II, that undergoes chemical transformation in a process in which it is entirely converted from its original composition and its emissions are insignificant
commercial use means used for the storage, display or dispensing of products, for sale to end users, in retail and food services
fire protection equipment means the equipment and systems utilised in fire prevention or suppression applications and includes fire extinguishers
organic Rankine cycle means a cycle containing condensable fluorinated greenhouse gas converting heat from a heat source into power for the generation of electric or mechanical energy
military equipment mean arms, munitions and war material intended specifically for military purposes which are necessary for the protection of the essential interests of the security of Member States
electrical switchgear means switching devices and their combination with associated control, measuring, protective and regulating equipment, and assemblies of such devices and equipment with associated interconnections, accessories, enclosures and supporting structures, intended for usage in connection with the generation, transmission, distribution and conversion of electric energy
multipack centralised refrigeration systems means systems with two or more compressors operated in parallel, which are connected to one or more common condensers and to a number of cooling devices such as display cases, cabinets, freezers or to chilled store rooms
primary refrigerant circuit of cascade systems means the primary circuit in indirect medium temperature systems where a combination of two or more separate refrigeration circuits are connected in series such that the primary circuit absorbs the condenser heat from a secondary circuit for the medium temperature
single split air conditioning systems means systems for room air conditioning that consist of one outdoor unit and one indoor unit linked by refrigerant piping, needing installation at the site of usage
detection risk means the risk that the verifier does not detect a material misstatement
accreditation means attestation by a national accreditation body that a verifier meets the requirements set by harmonised standards, within the meaning of point 9 of Article 2 of Regulation (EC) No 765/2008, and requirements set out in this Regulation to carry out the verification of an operator's or aircraft operator's report pursuant to this Regulation
verifier means a legal person or another legal entity carrying out verification activities pursuant to this Regulation and accredited by a national accreditation body pursuant to Regulation (EC) No 765/2008 and this Regulation or a natural person otherwise authorised, without prejudice to Article 5(2) of that Regulation, at the time a verification report is issued
verification means the activities carried out by a verifier to issue a verification report pursuant to this Regulation
misstatement means an omission, misrepresentation or error in the operator's or aircraft operator's reported data, not considering the uncertainty permissible under Article 12(1)(a) of Implementing Regulation (EU) 2018/2066
material misstatement means a misstatement that, in the opinion of the verifier, individually or when aggregated with other misstatements, exceeds the materiality level or could affect the treatment of the operator's or aircraft operator's report by the competent authority
operator’s or aircraft operator’s report means the annual emission report to be submitted by the operator or aircraft operator pursuant to Article 14(3) of Directive 2003/87/EC, the tonne-kilometre report to be submitted by the aircraft operator for the purposes of applying for the allocation of allowances pursuant to Articles 3e and 3f of that Directive, the baseline data report submitted by the operator pursuant to Article 4(2) of Delegated Regulation (EU) …/… or the data report submitted by the operator pursuant to Article 5(2) of that Regulation
scope of accreditation means activities referred to in Annex I for which accreditation is sought or has been granted
competence means the ability to apply knowledge and skills to carry out an activity
materiality level means the quantitative threshold or cut-off point above which misstatements, individually or when aggregated with other misstatements, are considered material by the verifier
control system means the operator's or aircraft operator's risk assessment and entire set of control activities, including the continuous management thereof, that an operator or aircraft operator has established, documented, implemented and maintained pursuant to Article 59 of Implementing Regulation (EU) 2018/2066 or pursuant to Article 11 of Delegated Regulation (EU) …/…, as appropriate
control activities means any acts carried out or measures implemented by the operator or aircraft operator to mitigate inherent risks
non-conformity means one of the following:
(a) for the purposes of verifying an operator's emission report, any act or omission of an act by the operator that is contrary to the greenhouse gas emissions permit and the requirements in the monitoring plan approved by the competent authority;
(b) for the purposes of verifying an aircraft operator's emission or tonne-kilometre report, any act or omission of an act by the aircraft operator that is contrary to the requirements in the monitoring plan approved by the competent authority;
(c) for the purposes of verifying the baseline data report submitted by the operator pursuant to Article 4(2)(a) of Delegated Regulation (EU) …/… or the new entrant data report submitted by the operator pursuant to Article 5(2) of that Regulation any act or omission of an act by the operator that is contrary to the requirements in the monitoring methodology plan;
(d) for the purposes of accreditation pursuant to Chapter IV, any act or omission of an act by the verifier that is contrary to the requirements of this Regulation
site means, for the purposes of verifying the emission or tonne-kilometre report of an aircraft operator, the locations where the monitoring process is defined and managed, including the locations where relevant data and information are controlled and stored
control environment means the environment in which the internal control system functions and the overall actions of an operator's or aircraft operator's management to ensure awareness of this internal control system
inherent risk means the susceptibility of a parameter in the operator's or aircraft operator's report to misstatements that could be material, individually or when aggregated with other misstatements, before taking into consideration the effect of any related control activities
control risk means the susceptibility of a parameter in the operator's or aircraft operator's report to misstatements that could be material, individually or when aggregated with other misstatements, and that will not be prevented or detected and corrected on a timely basis by the control system
verification risk means the risk, being a function of inherent risk, control risk and detection risk, that the verifier expresses an inappropriate verification opinion when the operator's or aircraft operator's report is not free of material misstatements
reasonable assurance means a high but not absolute level of assurance, expressed positively in the verification opinion, as to whether the operator's or aircraft operator's report subject to verification is free from material misstatement
analytical procedures means the analysis of fluctuations and trends in the data including an analysis of the relationships that are inconsistent with other relevant information or that deviate from predicted amounts
internal verification documentation means all internal documentation that a verifier has compiled to record all documentary evidence and justification of activities that are carried out for the verification of an operator's or aircraft operator's report
EU ETS lead auditor means an EU ETS auditor in charge of directing and supervising the verification team, who is responsible for performing and reporting on the verification of an operator's or aircraft operator's report
EU ETS auditor means an individual member of a verification team responsible for conducting a verification of an operator's or aircraft operator's report other than the EU ETS lead auditor
technical expert means a person who provides detailed knowledge and expertise on a specific subject matter needed for the performance of verification activities for the purposes of Chapter III and for the performance of accreditation activities for the purposes of Chapter V
level of assurance means the degree of assurance the verifier provides on the verification report based on the objective of reducing the verification risk according to the circumstances of the verification engagement
assessor means a person assigned by a national accreditation body to perform individually or as part of an assessment team an assessment of a verifier pursuant to this Regulation
lead assessor means an assessor who is given the overall responsibility for assessing a verifier pursuant to this Regulation
baseline data report means a report submitted by an operator pursuant to Article 4(2) of Delegated Regulation (EU) …/…
new entrant data report means a report submitted by an operator pursuant to Article 5(2) of Delegated Regulation (EU) …/…
allowance means an allowance to emit one tonne of carbon dioxide equivalent during a specified period, which shall be valid only for the purposes of meeting the requirements of this Directive and shall be transferable in accordance with the provisions of this Directive
emissions means the release of greenhouse gases into the atmosphere from sources in an installation or the release from an aircraft performing an aviation activity listed in Annex I of the gases specified in respect of that activity
greenhouse gases means the gases listed in Annex II and other gaseous constituents of the atmosphere, both natural and anthropogenic, that absorb and re-emit infrared radiation
greenhouse gas emissions permit means the permit issued in accordance with Articles 5 and 6
installation means a stationary technical unit where one or more activities listed in Annex I are carried out and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution
operator means any person who operates or controls an installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated
new entrant means any installation carrying out one or more of the activities listed in Annex I, which has obtained a greenhouse gas emissions permit for the first time within the period starting from three months before the date for submission of the list under Article 11(1), and ending three months before the date for the submission of the subsequent list under that Article
the public means one or more persons and, in accordance with national legislation or practice, associations, organisations or groups of persons
tonne of carbon dioxide equivalent means one metric tonne of carbon dioxide (CO2) or an amount of any other greenhouse gas listed in Annex II with an equivalent global-warming potential
Annex I Party means a Party listed in Annex I to the United Nations Framework Convention on Climate Change (UNFCCC) that has ratified the Kyoto Protocol as specified in Article 1(7) of the Kyoto Protocol
project activity means a project activity approved by one or more Annex I Parties in accordance with Article 6 or Article 12 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol
emission reduction unit or ERU means a unit issued pursuant to Article 6 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol
certified emission reduction or CER means a unit issued pursuant to Article 12 of the Kyoto Protocol and the decisions adopted pursuant to the UNFCCC or the Kyoto Protocol
aircraft operator means the person who operates an aircraft at the time it performs an aviation activity listed in Annex I or, where that person is not known or is not identified by the owner of the aircraft, the owner of the aircraft
commercial air transport operator means an operator that, for remuneration, provides scheduled or non-scheduled air transport services to the public for the carriage of passengers, freight or mail
administering Member State means the Member State responsible for administering the EU ETS in respect of an aircraft operator in accordance with Article 18a
attributed aviation emissions means emissions from all flights falling within the aviation activities listed in Annex I which depart from an aerodrome situated in the territory of a Member State and those which arrive in such an aerodrome from a third country
historical aviation emissions means the mean average of the annual emissions in the calendar years 2004, 2005 and 2006 from aircraft performing an aviation activity listed in Annex I
combustion means any oxidation of fuels, regardless of the way in which the heat, electrical or mechanical energy produced by this process is used, and any other directly associated activities, including waste gas scrubbing
electricity generator means an installation that, on or after 1 January 2005, has produced electricity for sale to third parties, and in which no activity listed in Annex I is carried out other than the ‘combustion of fuels’
target value means a concentration in the ambient air fixed with the aim of avoiding, preventing or reducing harmful effects on human health and the environment as a whole, to be attained where possible over a given period
total or bulk deposition means the total mass of pollutants which is transferred from the atmosphere to surfaces (e.g. soil, vegetation, water, buildings, etc.) in a given area within a given time
upper assessment threshold means a level specified in Annex II below which a combination of measurements and modelling techniques may be used to assess ambient air quality, in accordance with Article 6(3) of Directive 96/62/EC
lower assessment threshold means a level specified in Annex II below which the sole use of modelling or objective estimation techniques shall be possible to assess ambient air quality, in accordance with Article 6(4) of Directive 96/62/EC
fixed measurements means measurements taken at fixed sites either continuously or by random sampling, in accordance with Article 6(5) of Directive 96/62/EC
arsenic, cadmium, nickel and benzo(a)pyrene mean the total content of these elements and compounds in the PM10 fraction
PM10 means particulate matter, which passes through a size-selective inlet as defined in EN 12341 with a 50 % efficiency cut-off at 10 μm aerodynamic diameter
polycyclic aromatic hydrocarbons means those organic compounds, composed of at least two fused aromatic rings made entirely from carbon and hydrogen
total gaseous mercury means elemental mercury vapour (Hg0) and reactive gaseous mercury, i.e. water-soluble mercury species with sufficiently high vapour pressure to exist in the gas phase
component means an electronic system integrated in the IMSOC
network means a group of members having access to a specific component
network member means a Member State’s competent authority, the Commission, an EU agency, a third country’s competent authority or an international organisation that has access to at least one component
contact point means the contact point designated by the network member to represent it
Member State’s national system means a computerised information system owned and set up before the date of entry into force of Regulation (EU) 2017/625 by a Member State for the purpose of managing, handling and exchanging data, information and documents on official controls, and capable of electronically exchanging data with the relevant component
international organisation means any of the internationally recognised bodies listed in point (g) of Article 121 of Regulation (EU) 2017/625, or similar intergovernmental organisations
iRASFF means the electronic system implementing the RASFF and AAC procedures described in Article 50 of Regulation (EC) No 178/2002 and Articles 102 to 108 of Regulation (EU) 2017/625 respectively
risk means any direct or indirect risk to human health in connection with food, food contact material or feed in accordance with Article 50 of Regulation (EC) No 178/2002 or a serious risk to animal health or to the environment in connection with feed, including feed for animals not kept for food production, in accordance with Article 29 of Regulation (EC) No 183/2005
RASFF network means the Rapid alert system for the notification of risks as defined in point 8, established as a network by Article 50 of Regulation (EC) No 178/2002
AAC network means the network composed of the Commission and the liaison bodies designated by the Member States in accordance with Article 103(1) of Regulation (EU) 2017/625 for the purpose of facilitating communication between competent authorities
food fraud network means the network composed of the Commission, Europol and the liaison bodies designated by the Member States in accordance with Article 103(1) of Regulation (EU) 2017/625 for the specific purpose of facilitating the exchange of information on food fraud notifications as defined in point (21)
alert and cooperation network means a network composed of the RASFF, AAC and food fraud networks
single contact point means a contact point composed of the RASFF and AAC contact points in each Member State, whether or not physically located in the same administrative unit
non-compliance notification means a notification in iRASFF of a non-compliance that does not present a risk within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 106(1) of Regulation (EU) 2017/625, except non-serious risks to animal health and risks to plant health or animal welfare
alert notification means a notification in iRASFF of a serious direct or indirect risk deriving from food, food contact material or feed within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that requires or might require rapid action by another RASFF network member
information notification means a notification in iRASFF of a direct or indirect risk deriving from food, food contact material or feed according to Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that does not require rapid action by another RASFF network member
information notification for follow-up means an information notification related to a product that is or may be placed on the market of another RASFF network member’s country
information notification for attention eans an information notification related to a product that:
(i) either is present only in the notifying network member’s country; or
(ii) has not been placed on the market; or
(iii) is no longer on the market
news notification means a notification in iRASFF concerning a risk deriving from food, food contact material or feed within the meaning of Article 50 of Regulation (EC) No 178/2002 and Article 29 of Regulation (EC) No 183/2005 that has an informal source, contains unverified information or concerns as yet an unidentified product
border rejection notification means a notification in iRASFF of a rejection due to a risk as defined in point 8 of a batch, container or cargo of food, food contact material or feed as referred to in point (c) of Article 50(3) of Regulation (EC) No 178/2002
food fraud notification means a non-compliance notification in iRASFF concerning suspected intentional action by businesses or individuals for the purpose of deceiving purchasers and gaining undue advantage therefrom, in violation of the rules referred to in Article 1(2) of Regulation (EU) 2017/625
original notification means a non-compliance notification, an alert notification, an information notification, a news notification, a food fraud notification or a border rejection notification
follow-up notification means a notification in iRASFF that contains additional information in relation to an original notification
request means a request for administrative assistance in iRASFF based on an original or follow-up notification and enabling the exchange of information pursuant to Articles 104 to 108 of Regulation (EU) 2017/625
response means a response to a request for administrative assistance in iRASFF based on an original or follow-up notification and enabling the exchange of information pursuant to Articles 104 to 108 of Regulation (EU) 2017/625
notifying network member or contact point means the network member or contact point addressing a notification to another network member or contact point
notified network member or contact point means the network member or contact point to which a notification is addressed by another network member or contact point
requested network member or contact point means the network member or contact point to which a notification is addressed by another network member or contact point for the purpose of receiving a response
ADIS means the computerised information system for the notification and reporting of diseases to be set up and managed by the Commission in accordance with Article 22 of Regulation (EU) 2016/429
ADIS network means the network composed of the Commission and Member States’ competent authorities for the functioning of ADIS
EUROPHYT means the electronic notification system to be established by the Commission and to be connected to, and compatible with, the IMSOC for Member States’ submission of EUROPHYT outbreak notifications in accordance with Article 103 of Regulation (EU) 2016/2031
EUROPHYT outbreak notification means a notification to be submitted in EUROPHYT of any of the following:
(a) the officially confirmed presence on the Union territory of a Union quarantine pest, as referred to in points (a) and (b) of the first paragraph of Article 11 of Regulation (EU) 2016/2031;
(b) the officially confirmed presence of a pest not included in the list of Union quarantine pests, as referred to in Article 29(1) of Regulation (EU) 2016/2031;
(c) the presence in, or the imminent danger of entry into, or spread within, the Union territory of a pest not included in the list of Union quarantine pests, as referred to in Article 30(1) of Regulation (EU) 2016/2031;
(d) the officially confirmed presence of a protected zone quarantine pest, as referred to in Article 33(1) of Regulation (EU) 2016/2031
EUROPHYT interception notification means a notification to be submitted in TRACES in any of the situations described in point (c) of the first paragraph of Article 11, Article 40(4), Article 41(4), Article 46(4), the second, third and fourth subparagraphs of Article 49(6), Article 53(4), Article 54(4), Article 77(2) and Article 95(5) of Regulation (EU) 2016/2031
EUROPHYT interception network means the network composed by the Commission and Member States’ competent authorities for EUROPHYT interception notifications
EUROPHYT outbreak network means the network composed by the Commission and Member States’ competent authorities for the functioning of EUROPHYT
TRACES means the computerised system referred to in Article 133(4) of Regulation (EU) 2017/625 for the purposes of exchanging data, information and documents
TRACES network means the network composed by the Commission and Member States’ competent authorities for the functioning of TRACES
advanced electronic signature means an electronic signature complying with the technical specifications laid down in the Annex to Implementing Decision (EU) 2015/1506
advanced electronic seal means an electronic seal complying with the technical specifications laid down in the Annex to Implementing Decision (EU) 2015/1506
control unit means a unit that has the technology and equipment necessary for the efficient operation of the relevant component and designated as follows for that purpose:
(a) ‘central control unit’ for the central competent authority of a Member State;
(b) ‘regional control unit’ for any regional competent authority of a Member State;
(c) ‘local control unit’ for any local competent authority of a Member State
Genetically modified organism or GMO means genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC
Produced from GMOs means derived, in whole or in part, from GMOs, but not containing or consisting of GMOs
Traceability means the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market through the production and distribution chains
Unique identifier means a simple numeric or alphanumeric code which serves to identify a GMO on the basis of the authorised transformation event from which it was developed and providing the means to retrieve specific information pertinent to that GMO
Operator means a natural or legal person who places a product on the market or who receives a product that has been placed on the market in the Community, either from a Member State or from a third country, at any stage of the production and distribution chain, but does not include the final consumer
Final consumer means the ultimate consumer who will not use the product as part of any business operation or activity
The first stage of the placing on the market of a product means the initial transaction in the production and distribution chains, where a product is made available to a third party
Pre-packaged product means any single item offered for sale consisting of a product and the packaging into which it was put before being offered for sale, whether such packaging encloses the product completely or only partially, provided that the contents cannot be altered without opening or changing the packaging
MARPOL means the International Convention for the Prevention of Pollution from Ships, 1973 and the 1978 Protocol thereto
SOLAS means the International Convention for the Safety of Life at Sea, together with the protocols and amendments thereto
SAR Convention means the International Convention on Maritime Search and Rescue, 1979
ISM Code means the International Safety Management Code
IMDG Code means the International Maritime Dangerous Goods Code
IBC Code means the IMO International Code for the construction and equipment of ships carrying dangerous chemicals in bulk
IGC Code means the IMO International Code for the construction and equipment of ships carrying liquefied gases in bulk
BC Code means the IMO Code of Safe Practice for Solid Bulk Cargoes
INF Code means the IMO Code for the Safe Carriage of Irradiated Nuclear Fuel, Plutonium and High-Level Radioactive Wastes in Flasks on board Ships
IMO Resolution A.851(20) means International Maritime Organisation Resolution 851(20) entitled ‘General principles for ship reporting systems and ship reporting requirements, including guidelines for reporting incidents involving dangerous goods, harmful substances and/or marine pollutants’
IMO Resolution A.917(22) means International Maritime Organisation Resolution 917(22) entitled Guidelines for the onboard use of AIS, as amended by IMO Resolution A.956(23)
IMO Resolution A.949(23) means International Maritime Organisation Resolution 949(23) entitled Guidelines on places of refuge for ships in need of assistance
IMO Resolution A.950(23) means International Maritime Organisation Resolution 950(23) entitled Maritime assistance services (MAS)
IMO guidelines on the fair treatment of seafarers in the event of a maritime accident means the guidelines as annexed to resolution LEG. 3(91) of the IMO Legal Committee of 27 April 2006 and as approved by the Governing Body of the ILO in its 296th session of 12 to 16 June 2006
operator means the owner or manager of a ship
agent means any person mandated or authorised to supply information on behalf of the operator of the ship
shipper means any person by whom or in whose name or on whose behalf a contract of carriage of goods has been concluded with a carrier
company means a company within the meaning of Regulation 1(2) of Chapter IX of the SOLAS Convention
ship means any sea-going vessel or craft
dangerous goods means:
— goods classified in the IMDG Code,
— dangerous liquid substances listed in Chapter 17 of the IBC Code,
— liquefied gases listed in Chapter 19 of the IGC Code,
— solids referred to in Appendix B of the BC Code.
Also included are goods for the carriage of which appropriate preconditions have been laid down in accordance with paragraph 1.1.3 of the IBC Code or paragraph 1.1.6 of the IGC Code
polluting goods means:
— oils as defined in Annex I to the MARPOL Convention,
— noxious liquid substances as defined in Annex II to the MARPOL Convention,
— harmful substances as defined in Annex III to the MARPOL Convention
cargo transport unit means a road freight vehicle, a railway freight wagon, a freight container, a road tank vehicle, a railway wagon, or portable tank
address means the name and the communication links whereby contact may, where necessary, be made with the operator, agent, port authority, competent authority or any other authorised person or body in possession of detailed information regarding the ship's cargo
competent authorities means the authorities and organisations designated by Member States to perform functions under this Directive
port authority means the competent authority or body designated by Member States for each port to receive and pass on information reported pursuant to this Directive
place of refuge means a port, the part of a port or another protective berth or anchorage or any other sheltered area identified by a Member State for accommodating ships in distress
coastal station means any of the following, designated by Member States pursuant to this Directive: a vessel traffic service; a shore-based installation responsible for a mandatory reporting system approved by the IMO; or a body responsible for coordinating search and rescue operations or operations to tackle pollution at sea
vessel traffic service (VTS) means a service designed to improve the safety and efficiency of vessel traffic and to protect the environment, which has the capability to interact with the traffic and to respond to traffic situations developing in the VTS area
ship’s routing system means any system of one or more routes or routing measures aimed at reducing the risk of casualties; it includes traffic separation schemes, two-way routes, recommended tracks, areas to be avoided, inshore traffic zones, roundabouts, precautionary areas and deep-water routes
traditional ships means all kinds of historical ships and their replicas including those designed to encourage and promote traditional skills and seamanship, that together serve as living cultural monuments, operated according to traditional principles of seamanship and technique
casualty means a casualty within the meaning of the IMO Code for the investigation of marine casualties and incidents
SafeSeaNet means the Community maritime information exchange system developed by the Commission in cooperation with the Member States to ensure the implementation of Community legislation
scheduled service means a series of ship crossings operated so as to serve traffic between the same two or more ports, either according to a published timetable or with crossings so regular or frequent that they constitute a recognisable systematic series
fishing vessel means any vessel equipped for commercial exploitation of living aquatic resources
ship in need of assistance means, without prejudice to the provisions of the SAR Convention concerning the rescue of persons, a ship in a situation that could give rise to its loss or an environmental or navigational hazard
LRIT means a system for the long-range identification and tracking of ships in accordance with SOLAS regulation V/19-1
International Conventions means the following conventions, including their Protocols and amendments thereto, in their up-to-date versions:
(i) the 1974 International Convention for the Safety of Life at Sea (the 1974 SOLAS Convention); and
(ii) the 1966 International Convention on Load Lines
Intact Stability Code means the ‘Code on Intact Stability for all types of ships covered by IMO Instruments’ contained in IMO Assembly Resolution A.749(18) of 4 November 1993, or the ‘International Code on Intact Stability, 2008’ contained in IMO Resolution MSC.267(85) of 4 December 2008, in their up-to-date versions
High Speed Craft Code means the ‘International Code for Safety of High Speed Craft’ contained in IMO Resolution MSC 36 (63) of 20 May 1994, or the International Code for Safety of High-Speed Craft, 2000 (2000 HSC Code), contained in IMO Resolution MSC.97(73) of December 2000, in their up-to-date versions
GMDSS means the Global Maritime Distress and Safety System as laid down in Chapter IV of the 1974 SOLAS Convention, as amended
a passenger ship means a ship which carries more than 12 passengers
ro-ro passenger ship means a ship carrying more than 12 passengers, having ro-ro cargo spaces or special category spaces, as defined in Regulation II-2/A/2 contained in Annex I
high-speed passenger craft means a high-speed craft as defined in Regulation X/1 of the 1974 SOLAS Convention, as amended, which carries more than 12 passengers, with the exception of passenger ships engaged on domestic voyages in sea areas of Class B, C or D when:
(i) their displacement corresponding to the design waterline is less than 500 m3; and
(ii) their maximum speed, as defined in Regulation 1.4.30 of the 1994 High Speed Craft Code and Regulation 1.4.38 of the 2000 High Speed Craft Code, is lest than 20 knot
new ship means a ship the keel of which was laid or which was at a similar stage of construction on or after 1 July 1998; a ‘similar stage of construction’ means the stage at which:
(i) construction identifiable with a specific ship begins; and
(ii) assembly of that ship has commenced comprising at least 50 tonnes or 1 % of the estimated mass of all structural material, whichever is less
existing ship means a ship which is not a new ship
age means the age of the ship, expressed in terms of the number of years after the date of its delivery
passenger means every person other than:
(i) the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship; and
(ii) a child under one year of age
length of a ship unless expressly provided otherwise, means 96 % of the total length on a water line at 85 % of the least moulded depth measured from the top of the keel, or the length from the fore side of the stem to the axis of the rudder stock on that waterline, if that be greater. In ships designed with a rake of keel the waterline on which this length is measured shall be parallel to the designed waterline
bow height means the bow height defined in Regulation 39 of the 1966 International Convention on Load Lines
ship with a full deck means a ship that is provided with a complete deck, exposed to weather and sea, which has permanent means of closing all openings in the weatherpart thereof and below which all openings in the sides of the ship are fitted with permanent means of at least weathertight closing;
the complete deck may be a watertight deck or equivalent structure consisting of a non-watertight deck completely covered by a weathertight structure of adequate strength to maintain the weathertight integrity and fitted with weathertight closing appliances
international voyage means a voyage by sea from a port of a Member State to a port outside that Member State, or conversely
domestic voyage means a voyage in sea areas from a port of a Member State to the same or another port within that Member State
sea area means any sea area or sea route established pursuant to Article 4;
however, for the application of the provisions on radiocommunication, the definitions of sea areas will be those defined in Regulation 2, Chapter IV of the 1974 SOLAS Convention, as amended
port area means an area other than a sea area established pursuant to Article 4, defined by the Member State with jurisdiction over it, extending to the outermost permanent harbour works forming an integral part of the harbour system, or to the limits defined by natural geographical features protecting an estuary or similar sheltered area
Administration of the flag State means the competent authorities of the State whose flag the ship or craft is entitled to fly
port State means a Member State to or from whose port or ports a ship or craft flying a flag other than the flag of that Member State is carrying out domestic voyages
a mile is 1 852 metres
significant wave height means the average height of the highest third of wave heights observed over a given period
persons with reduced mobility means persons who have a particular difficulty when using public transport, including elderly persons, persons with disabilities, persons with sensory impairments and wheelchair users, pregnant women and persons accompanying small children
sailing ship means a ship propelled by sails, even if fitted with mechanical propulsion for auxiliary and emergency purposes
equivalent material means aluminium alloy or any other non-combustible material which, by itself or due to the insulation provided, maintains structural and integrity properties equivalent to steel at the end of the applicable exposure to the standard fire test
standard fire test means a test in which specimens of the relevant bulkheads or decks are exposed in a test furnace to temperatures corresponding approximately to the standard time-temperature curve in accordance with the test method specified in the 2010 International Code for Application of Fire Test Procedures, contained in IMO Resolution MSC.307(88) of 3 December 2010, in its up-to-date version
traditional ship means any kind of historical passenger ship designed before 1965 and their replicas built predominantly with the original materials, including those designed to encourage and promote traditional skills and seamanship, that together serve as living cultural monuments, operated according to traditional principles of seamanship and technique
pleasure yacht or pleasure craft means a vessel not engaged in trade, regardless of the means of propulsion
tender means a ship-carried boat used for transferring more than 12 passengers from a stationary passenger ship to shore and back
offshore service ship means a ship used to transport and accommodate industrial personnel who do not conduct work on board that is essential to the business of the ship
offshore service craft means a craft used to transport and accommodate industrial personnel who do not conduct work on board that is essential to the business of the craft
repairs, alterations and modifications of a major character means any of the following:
— any change that substantially alters the dimensions of a ship, such as lengthening by adding new midbody,
— any change that substantially alters the passenger-carrying capacity of a ship, such as converting the vehicle deck to passenger accommodation,
— any change that substantially increases a ship's service life, such as renewing the passenger accommodation on one entire deck,
— any conversion of any type of ship into a passenger ship
Non-combustible material is a material which neither burns nor gives off flammable vapours in sufficient quantity for self-ignition when heated to approximately 750 °C, this being determined by a fire test in accordance with the IMO Resolution A.799(19) ‘Revised recommendation on test methods for qualifying marine construction materials as non-combustible’. Any other material is a combustible material
Non-combustible material is a material which neither burns nor gives off flammable vapours in sufficient quantity for self-ignition when heated to approximately 750 °C, this being determined in accordance with the Fire Test Procedures Code. Any other material is a combustible material
standard fire test is one in which specimens of the relevant bulkheads or decks are exposed in a test furnace to temperatures corresponding approximately to the standard time-temperature curve. The specimen shall have an exposed surface of not less than 4,65 m2 and height (or length of deck) of 2,44 metres, resembling as closely as possible the intended construction and including where appropriate at least one joint. The standard time-temperature curve is defined by a smooth curve drawn through the following internal furnace temperature points:
initial internal furnace temperature 20 °C
at the end of the first 5 minutes 576 °C
at the end of 10 minutes 679 °C
at the end of 15 minutes 738 °C
at the end of 30 minutes 841 °C
at the end of 60 minutes 945 °C
standard fire test is one in which the specimens of the relevant bulkheads and decks are exposed in a test furnace to temperatures corresponding approximately to the standard temperature curve. The test methods shall be in accordance with the Fire Test Procedures Code
‘A’ class divisions are those divisions formed by bulkheads and decks which comply with the following:
.1 they shall be constructed of steel or other equivalent material;
.2 they shall be suitably stiffened;
.3 they shall be so constructed as to be capable of preventing the passage of smoke and flame to the end of the one-hour standard fire test;
.4 they shall be insulated with approved non-combustible materials such that the average temperature of the unexposed side will not rise more than 140 °C above the original temperature, nor will the temperature, at any one point, including any joint, rise more than 180 °C above the original temperature, within the time listed below:
class ‘A-60’ 60 minutes
class ‘A-30’ 30 minutes
class ‘A-15’ 15 minutes
class ‘A-0’ 0 minutes
.5 The Administration of the flag State shall require a test of a prototype bulkhead or deck to ensure that it meets the above requirements for integrity and temperature rise in accordance with the IMO Resolution A.754(18).
For class B, C and D ships constructed on or after 1 January 2003, ‘IMO Resolution A.754(18)’ shall read ‘Fire Test Procedures Code’
‘B’ class divisions are those divisions formed by bulkheads, decks, ceilings or linings which comply with the following:
.1 they shall be so constructed as to be capable of preventing the passage of flame to the end of the first half hour of the standard fire test;
.2 they shall have an insulation value such that the average temperature of the unexposed side will not rise more than 140 °C above the original temperature, nor will the temperature at any one point, including any joint, rise more than 225 °C above the original temperature within the time listed below:
class ‘B-15’ 15 min
class ‘B-0’ 0 min
.3 they shall be constructed of approved non-combustible materials and all materials entering into the construction and erection of ‘B’ class divisions shall be non-combustible, with the exception that combustible veneers may be permitted provided they meet other requirements of this chapter;
.4 the Administration of the flag State shall require a test of a prototype division to ensure that it meets the above requirements for integrity and temperature rise in accordance with IMO Resolution A.754(18).
For class B, C and D ships constructed on or after 1 January 2003, ‘IMO Resolution A.754(18)’ shall read ‘Fire Test Procedures Code’
‘C’ class divisions are divisions constructed of approved non-combustible materials. They need meet neither requirements relative to the passage of smoke and flame nor limitations relative to the temperature rise. Combustible veneers are permitted provided they meet other requirements of this chapter
Continuous ‘B’ class ceilings or linings are those ‘B’ class ceilings or linings which terminate only at an ‘A’ or ‘B’ class division
Steel or other equivalent material Where the words ‘steel or other equivalent material’ occur, ‘equivalent material’ means any non-combustible material which, by itself or due to insulation provided, has structural and integrity properties equivalent to steel at the end of the applicable exposure to the standard fire test (e.g. aluminium alloy with appropriate insulation)
Low flame spread means that the surface thus described will adequately restrict the spread of flame, this being determined by a fire test according to IMO Resolution A.653(16), for bulkhead, ceiling and deck finish materials
Low flame spread means that the surface thus described will adequately restrict the spread of flame, this being determined in accordance with the Fire Test Procedures Code
Main vertical zones are those sections into which the hull, superstructure, and deckhouses are divided by ‘A’ class divisions, the mean length and width of which on any deck does not in general exceed 40 metres
Accommodation spaces are those spaces used for public spaces, corridors, lavatories, cabins, offices, hospitals, cinemas, games and hobbies rooms, barber shops, pantries containing no cooking appliances and similar spaces
Public spaces are those portions of the accommodation which are used for halls, dining rooms, lounges and similar permanently enclosed spaces
Service spaces are those spaces used for galleys, pantries containing cooking appliances, lockers, mail and specie rooms, storerooms, workshops other than those forming part of the machinery spaces, and similar spaces and trunks to such spaces
Cargo spaces are all spaces used for cargo (including cargo oil tanks) and trunks to such spaces
Vehicle spaces are cargo spaces intended for the carriage of motor vehicles with fuel in their tanks for their own propulsion
Ro-ro cargo spaces are spaces not normally subdivided in any way and extending to either a substantial length or the entire length of the ship in which motor vehicles with fuel in their tanks for their own propulsion and/or goods (packaged or in bulk, in or on rail or road cars, vehicles (including road and rail tankers), trailers, containers, pallets, dismountable tanks or in or on similar stowage units or other receptacles) can be loaded and unloaded normally in a horizontal direction
Open ro-ro cargo spaces are ro-ro cargo spaces either open at both ends, or open at one end and provided with adequate natural ventilation effective over the entire length through permanent openings in the side plating or deckhead, or from above, and for ships constructed on or after 1 January 2003 having a total area of at least 10 % of the total area of the space sides
Open vehicle spaces are those vehicle spaces either open at both ends or having an opening at one end and being provided with adequate natural ventilation effective over their entire length through permanent openings distributed in the side plating or deckhead or from above, and for ships constructed on or after 1 January 2003 having a total area of at least 10 % of the total area of the space sides
Closed ro-ro cargo spaces are ro-ro cargo spaces which are neither open ro-ro cargo spaces nor weather decks
Closed vehicle spaces are vehicle spaces which are neither open vehicle spaces nor weather decks
Weather deck is a deck which is completely exposed to the weather from above and from at least two sides
Special category spaces are those enclosed vehicle spaces above or below the bulkhead deck into and from which such vehicles can be driven and to which passengers have access. Special category spaces may be accommodated on more than one deck provided that the total overall clear height for vehicles does not exceed 10 metres
Machinery spaces of category A are those spaces and trunks to such spaces which contain:
.1 internal combustion machinery used for main propulsion; or
.2 internal combustion machinery used for purposes other than main propulsion where such machinery has in the aggregate a total power output of not less than 375 kW; or
.3 any oil-fired boiler or oil fuel unit
Machinery spaces are all machinery spaces of category A and all other spaces containing propelling machinery, boilers, oil fuel units, steam and internal combustion engines, generators and major electrical machinery, oil filling stations, refrigerating, stabilising, ventilation and air conditioning machinery, and similar spaces, and trunks to such spaces
Oil fuel unit is the equipment used for the preparation of oil fuel for delivery to an oil-fired boiler, or equipment used for the preparation for delivery of heated oil to an internal combustion engine, and includes any oil pressure pumps, filters and heaters dealing with oil at a pressure of more than 0,18 N/mm2
Control stations are those spaces in which the ship’s radio or main navigating equipment or the emergency source of power is located or where the fire recording or fire control equipment is centralised
Central control station is a control station in which the following control and indicator functions are centralised:
.1 fixed fire detection and alarm systems;
.2 automatic sprinklers, fire detection and alarm systems;
.3 fire door indicator panels;
.4 fire doors closures;
.5 watertight door indicator panels;
.6 watertight door closures;
.7 ventilation fans;
.8 general/fire alarms;
.9 communication systems including telephones; and
.10 microphones to public address systems
Continuously manned central control station is a central control station which is continuously manned by a responsible member of the crew
Rooms containing furniture and furnishings of restricted fire risk are, for the purpose of Regulation II-2/B/4, those rooms containing furniture and furnishings of restricted fire risk (whether cabins, public spaces, offices and other types of accommodation) in which:
.1 all case furniture such as desks, wardrobes, dressing tables, bureaux, dressers, is constructed entirely of approved non-combustible materials, except that a combustible veneer not exceeding 2 mm may be used on the working surface of such articles;
.2 all free-standing furniture such as chairs, sofas, tables, is constructed with frames of non-combustible materials;
.3 all draperies, curtains and other suspended textile materials have qualities of resistance to the propagation of flame not inferior to those of wool of mass 0,8 kg/m2, in accordance with IMO Resolution A.471(XII), as amended.
For class B, C and D ships constructed on or after 1 January 2003, ‘IMO Resolution A.471(XII)’, as amended, shall read ‘Fire Test Procedures Code’;
.4 all floor coverings have qualities of resistance to the propagation of flame not inferior to those of an equivalent woollen material used for the same purpose.
For class B, C and D ships constructed on or after 1 January 2003, this subparagraph shall read:
all floor coverings have low flame spread characteristics;
.5 all exposed surfaces of bulkheads, linings and ceilings have low flame-spread characteristics; and
.6 all upholstered furniture has qualities of resistance to the ignition and propagation of flame in accordance with the Fire Test Procedures of Upholstered Furniture of IMO Resolution A.652(16)
For class B, C and D ships constructed on or after 1 January 2003, ‘IMO Resolution A.652(16)’ shall read ‘Fire Test Procedures Code’.
FOR CLASS B, C AND D SHIPS CONSTRUCTED ON OR AFTER 1 JANUARY 2003
.7 all bedding components have qualities of resistance to the ignition and propagation of flame, this being determined in accordance with the Fire Test Procedures Code
Ro-ro passenger ship means a passenger ship with ro-ro cargo spaces or special category spaces as defined in this Regulation
Fire Test Procedures Code means the International Code for Application of Fire Test Procedures, as adopted by Resolution MSC.61(67), as amended
Fire Safety Systems Code means the International Code for Fire Safety Systems adopted by Resolution MSC.98(73), as amended
Flashpoint is the temperature in degrees Celsius (closed cup test) at which a product will give off enough flammable vapour to be ignited, as determined by an approved flashpoint apparatus
Prescriptive requirements mean the constructive characteristics, limiting dimensions or fire safety systems specified in this chapter
Fire damper means, for the purpose of implementing Regulation II-2/B/9a, a device installed in a ventilation duct which under normal conditions remains open allowing flow in the duct and is closed during a fire, preventing the flow in the duct to restrict the passage of fire
automatic fire damper means a fire damper that closes independently in response to exposure to fire products
manual fire damper means a fire damper that is intended to be opened or closed by the crew by hand at the damper itself
remotely operated fire damper means a fire damper that is closed by the crew through a control located at a distance away from the controlled damper
Smoke damper means, for the purpose of implementing Regulation II-2/B/9a, a device installed in a ventilation duct which under normal conditions remains open allowing flow in the duct and is closed during a fire, preventing the flow in the duct to restrict the passage of smoke and hot gases. A smoke damper is not expected to contribute to the integrity of a fire rated division penetrated by a ventilation duct
automatic smoke damper means a smoke damper that closes independently in response to exposure to smoke or hot gases
manual smoke damper means a smoke damper intended to be opened or closed by the crew by hand at the damper itself
remotely operated smoke damper means a smoke damper that is closed by the crew through a control located at a distance away from the controlled damper
Subdivision load line is the waterline used in determining the subdivision of the ship
Deepest subdivision load line is the waterline which corresponds to the greatest draught permitted by the subdivision requirements which are applicable
Length of the ship is the length measured between perpendiculars taken at the extremities of the deepest subdivision load line
Breadth of the ship is the extreme width from outside of frame to outside of frame at or below the deepest subdivision load line
Draught is the vertical distance from the moulded base line amidships to the subdivision load line in question
Deadweight is the difference in tonnes between the displacement of a ship in water of a specific gravity of 1,025 at the load waterline corresponding to the assigned summer freeboard and the lightweight of the ship
Lightweight is the displacement of a ship in tonnes without cargo, fuel, lubricating oil, ballast water, fresh water and feedwater in tanks, consumable stores, and passengers and crew and their effects
Bulkhead deck is the uppermost deck up to which the transverse watertight bulkheads are carried
Margin line is a line drawn at least 76 mm below the upper surface of the bulkhead deck at side
Permeability of a space is the percentage of that space which can be occupied by water. The volume of a space which extends above the margin line shall be measured only to the height of that line
Machinery space is to be taken as extending from the moulded base line to the margin line and between the extreme main transverse watertight bulkheads, bounding the spaces containing the main and auxiliary propulsion machinery, and boilers serving the needs of propulsion
Passenger spaces are those spaces which are provided for the accommodation and use of passengers, excluding baggage, store, provision and mail rooms
Watertight in relation to structure means capable of preventing the passage of water through the structure in any direction under the head of water likely to occur in the intact or damage condition
Weathertight means that water will not penetrate into the ship in any sea conditions
Ro-ro passenger ship means a passenger ship with ro-ro cargo spaces or special category spaces as defined in Regulation II-2/A/2
Steering gear control system is the equipment by which orders are transmitted from the navigating bridge to the steering gear power units. Steering gear control systems comprise transmitters, receivers, hydraulic control pumps and their associated motors, motor controllers, piping and cables
Main steering gear is the machinery, rudder actuators, steering gear power units, if any, and ancillary equipment and the means of applying torque to the rudder stock (e.g. tiller or quadrant) necessary for effecting movement of the rudder for the purpose of steering the ship under normal service conditions
Steering gear power unit is:
1. in the case of electric steering gear, an electric motor and its associated electrical equipment;
2. in the case of electrohydraulic steering gear, an electric motor and its associated electrical equipment and connected pump;
3. in the case of other hydraulic steering gear, a driving engine and connected pump
Auxiliary steering gear is the equipment other than any part of the main steering gear necessary to steer the ship in the event of failure of the main steering gear but not including the tiller, quadrant or components serving the same purpose
Normal operational and habitable condition is a condition under which the ship as a whole, the machinery, services, means and aids ensuring propulsion, ability to steer, safe navigation, fire and flooding safety, internal and external communications and signals, means of escape, and emergency boat winches, as well as the designed comfortable conditions of habitability are in working order and functioning normally
Emergency condition is a condition under which any services needed for normal operational and habitable conditions are not in working order due to failure of the main source of electrical power
Main source of electrical power is a source intended to supply electrical power to the main switchboard for distribution to all services necessary for maintaining the ship in normal operational and habitable condition
Dead ship condition is the condition under which the main propulsion plant, boilers and auxiliaries are not in operation due to the absence of power
Main generating station is the space in which the main source of electrical power is situated
Main switchboard is a switchboard which is directly supplied by the main source of electrical power and is intended to distribute electrical energy to the ship’s services
Emergency switchboard is a switchboard which in the event of failure of the main electrical power supply system is directly supplied by the emergency source of electrical power or the transitional source of emergency power and is intended to distribute electrical energy to the emergency services
Emergency source of electrical power is a source of electrical power, intended to supply the emergency switchboard in the event of failure of the supply from the main source of electrical power
Maximum ahead service speed is the greatest speed which the ship is designed to maintain in service at sea at the deepest seagoing draught
Maximum astern speed is the speed which it is estimated the ship can attain at the designed maximum astern power at the deepest seagoing draught
Machinery spaces are all machinery spaces of category A and all other spaces containing propelling machinery, boilers, oil fuel units, steam and internal combustion engines, generators and major electrical machinery, oil filling stations, refrigerating, stabilising, ventilation and air conditioning machinery, and similar spaces, and trunks to such spaces
Machinery spaces of category A are those spaces and trunks to such spaces which contain:
.1 internal combustion machinery used for main propulsion; or
.2 internal combustion machinery used for purposes other than main propulsion where such machinery has in the aggregate a total power output of not less than 375 kW; or
.3 any oil-fired boiler or oil fuel unit
Power actuating system is the hydraulic equipment provided for supplying power to turn the rudderstock, comprising a steering gear power unit or units, together with the associated pipes and fittings, and a rudder actuator. The power actuating systems may share common mechanical components, i.e. tiller, quadrant and rudder stock, or components serving the same purpose
Control stations are those spaces in which the ship’s radio or main navigating equipment or the emergency source of power is located or where the fire recording or fire control equipment is centralised
LSA Code means the International Life-Saving Appliance (LSA) Code contained in IMO Resolution MSC.48(66), as amended
ship means a ship falling within the scope of the international conventions
ship flying the flag of a Member State means a ship registered in and flying the flag of a Member State in accordance with its legislation. Ships not corresponding to this definition are assimilated to ships flying the flag of a third country
inspections and surveys means inspections and surveys that are mandatory under the international conventions
international conventions means the International Convention for the Safety of Life at Sea of 1 November 1974 (SOLAS 74) with the exception of chapter XI-2 of the Annex thereto, the International Convention on Load Lines of 5 April 1966 and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (MARPOL), together with the protocols and amendments thereto, and the related codes of mandatory status in all Member States, with the exception of paragraphs 16.1, 18.1 and 19 of part 2 of the IMO Instruments Implementation Code, and of sections 1.1, 1.3, 3.9.3.1, 3.9.3.2 and 3.9.3.3 of part 2 of the IMO Code for Recognized Organizations, in their up-to-date version
organisation means a legal entity, its subsidiaries and any other entities under its control, which jointly or separately carry out tasks falling under the scope of this Directive
control means, for the purpose of point (e), rights, contracts or any other means, in law or in fact, which, either separately or in combination confer the possibility of exercising decisive influence on a legal entity or enable that entity to carry out tasks falling under the scope of this Directive
authorisation means an act whereby a Member State grants an authorisation or delegates powers to a recognised organisation
statutory certificate means a certificate issued by or on behalf of a flag State in accordance with the international conventions
rules and procedures means a recognised organisation’s requirements for the design, construction, equipment, maintenance and survey of ships
class certificate means a document issued by a recognised organisation certifying the fitness of a ship for a particular use or service in accordance with the rules and procedures laid down and made public by that recognised organisation
cargo ship safety radio certificate means the certificate introduced by the 1988 Protocol amending SOLAS, adopted by the International Maritime Organisation (IMO)
organism means any biological entity capable of replication or of transferring genetic material
genetically modified organism (GMO) means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination;
Within the terms of this definition:
(a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1;
(b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification
deliberate release means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment
placing on the market means making available to third parties, whether in return for payment or free of charge;
The following operations shall not be regarded as placing on the market:
— making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms ( 1 ) including culture collections,
— making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC,
— making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive
notification means the submission of the information required under this Directive to the competent authority of a Member State
notifier means the person submitting the notification
product means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market
environmental risk assessment means the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II
direct effects refers to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events
indirect effects refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management.
Observations of indirect effects are likely to be delayed
immediate effects refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect
delayed effects refers to effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release
Higher plants shall mean plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae)
equipment for use outdoors means all machinery defined in Article 1(2) of Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery which is either self-propelled or can be moved and which, irrespective of the driving element(s), is intended to be used, according to its type, in the open air and which contributes to environmental noise exposure. The use of equipment in an ambience where the transmission of sound is not or not significantly affected (for instance under tents, under roofs for protection against rain or in the shell of houses) is regarded as use in the open air. It also means non-powered equipment for industrial or environmental applications which is intended, according to its type, to be used outdoors and which contributes to environmental noise exposure. All these types of equipment are hereinafter referred to as ‘equipment’
marking means the visibly, legibly and indelibly affixing on the equipment of the CE marking defined in Decision 93/465/EEC accompanied by the indication of the guaranteed sound power level
sound power level L WA means the A-weighted sound power in dB in relation to 1 pW as defined in EN ISO 3744:1995 and EN ISO 3746:1995
measured sound power level means a sound power level as determined from measurements as laid down in Annex III; measured values may be determined either from a single machine representative for the type of equipment or from the average of a number of machines
guaranteed sound power level means a sound power level determined in accordance with the requirements laid down in Annex III which includes the uncertainties due to production variation and measurement procedures and where the manufacturer, or his authorised representative established in the Community, confirms that according to the technical instruments applied and referred to in the technical documentation it is not exceeded
animal shall mean any animal of the ovine or caprine species
holding shall mean any establishment, any structure, or in the case of free-range farming, any environment, in which animals are held, reared or handled on a permanent or temporary basis, except veterinary practices or clinics
keeper shall mean any natural or legal person with responsibility for animals, even temporarily, except veterinary practices or clinics
competent authority shall mean the central authority or authorities of a Member State responsible for, or entrusted with, carrying out veterinary checks and implementing this Regulation, or, in the case of monitoring for premiums, the authority entrusted with implementing Regulation (EC) No 1782/2003
farm or agricultural holding means a single unit, both technically and economically, that has a single management and that undertakes economic activities in agriculture in accordance with Regulation (EC) No 1893/2006 belonging to groups A.01.1, A.01.2, A.01.3, A.01.4, A.01.5 or to the ‘maintenance of agricultural land in good agricultural and environmental condition’ of group A.01.6 within the economic territory of the Union, either as its primary or secondary activity. Regarding activities of class A.01.49, only the activities ‘Raising and breeding of semi-domesticated or other live animals’ (with the exception of raising of insects) and ‘Bee-keeping and production of honey and beeswax’ are included
common land agricultural unit means an entity of land on which common rights apply and which is used by two or more agricultural holdings for agricultural production, but is not allocated amongst them
region means the territorial unit of the Nomenclature of Territorial Units for Statistics (NUTS), defined in accordance with Regulation (EC) No 1059/2003
livestock unit means a standard measurement unit that allows for the aggregation of the various categories of livestock in order for them to be compared; the coefficients for establishing the livestock units for individual livestock categories are listed in Annex I
utilised agricultural area or UAA means the land area used for farming, including arable land, permanent grassland, permanent crops, and other utilised agricultural land
reference year means a calendar year to which the reference periods refer
kitchen garden means areas used for food production intended for one's own consumption
module means one or more data sets organised in order to cover topics
topic means the content of the information to be collected about the statistical units, each topic covering a number of detailed topics
detailed topic means the detailed content of the information to be collected about the statistical units related to a specific topic, each detailed topic covering a number of variables
variable means a characteristic of a unit being observed that may assume more than one of a set of values
statistical unit means the basic observation unit, namely a natural person, household, family, living quarter or conventional dwelling
individual enumeration means the collection of information on each statistical unit so that its characteristics can be recorded separately and cross-classified with other characteristics
simultaneity means that the information obtained in a census refers to the same point in time (reference date)
universality within a defined territory means that data are provided for all statistical units within a precisely defined territory. Where the statistical units are persons, ‘universality within a defined territory’ means that data are provided based on information for all persons who have their usual residence in the defined territory (total population)
availability of small-area data means the availability of data for small geographical areas and small groups of statistical units
defined periodicity means the regular conducting of censuses at the beginning of every decade, including the continuity of registers
data source means the set of data records for statistical units and/or events relating to the statistical units which forms a direct basis for the production of census data about one or more specified topics for a specified target population
target population means the set of all statistical units in a defined geographical area at the reference date which qualify for reporting on one or more specified topics. It includes each valid statistical unit only once
estimated target population means the best available approximation of the target population. It consists of the census population plus under-coverage minus over-coverage
census population means the set of statistical units that is factually represented by the census results on one or more specified topics for a specified target population. The data records for the census population are those in the data source for the specified target population, including all imputed records and excluding all deleted records. If a data source comprises, as a matter of methodological principle, data records for only a sample of the statistical units in its estimated target population, the census population includes the complementary set of statistical units, in addition to the statistical units in the sample
complementary set of statistical units means the set of those statistical units that belong to an estimated target population, but on which, as a result of an applied sampling methodology, the data source contains no data records
coverage assessment means a study of the difference between a specified target population and its census population
post-enumeration survey means a survey conducted shortly after the enumeration for coverage and content assessment purposes
under-coverage means the set of all statistical units that belong to a specified target population but are not included in the corresponding census population
over-coverage means the set of all statistical units that are included in a census population used to report on a specified target population, but without belonging to that target population
record imputation means the assignment of an artificial but plausible data record to exactly one geographical area at the most detailed geographical level for which census data are produced, and the imputation of that data record into a data source
record deletion means the act of deleting or ignoring/not taking into account a data record that is included in a data source used to report on a specified target population but does not report any valid information on any statistical unit within that target population
item imputation means the insertion of an artificial but plausible value on a specific topic into a data record that already exists in a data source but either does not contain this value or contains a value that is considered implausible
questionnaire-based data means data originally obtained from respondents by means of a questionnaire in the context of a collection of statistical data that refer to a specified point in time
record linkage means the process of merging information from different data sources by comparing records for individual statistical units and merging information referring to the same statistical unit
unique identifier means a variable or set of variables in the data records in a data source or any list of statistical units which is used for
— verifying that the data source (or list of statistical units) includes no more than one data record for each statistical unit, and/or
— record linkage
register means a repository of information about statistical units which is directly updated in the course of events affecting the statistical units
register-based data means data in or from a register
matching of registers means record linkage where all matched data sources are contained in registers
data extraction means the process of retrieving census information from information contained in a register and relating to individual statistical units
coding means the process of converting information into codes representing classes within a classification scheme
capturing means the process by which collected data are imported into a form suitable for further processing
record editing means the process of checking and modifying data records to make them plausible while at the same time preserving major parts of them
generation of a household means the identification of a private household according to the household-dwelling concept as defined in the Annex to Implementing Regulation (EU) 2017/543 under the topic ‘Household status’
generation of a family means the identification of a family based on information on whether the persons live in the same household, but with no or incomplete information on family relationships between them. The term ‘family’ is specified in ‘family nucleus’ as defined in the Annex to Implementing Regulation (EU) 2017/543 under the topic ‘Family status
unit no-information means the failure to collect any data from a statistical unit that is in the census population
statistical disclosure control means the methods and processes applied in order to minimise the risk of disclosing information on individual statistical units when releasing statistical information
estimation means the calculation of statistical estimates using a mathematical formula and/or algorithm applied to the available data
data structure definition means a set of structural metadata associated with a data set, which includes information about how topics are associated with the measures, dimensions and attributes of a hypercube, along with breakdowns, information about the representation of data and related descriptive metadata
consumer prices means the purchase prices paid by households to purchase individual products by means of monetary transactions
house prices means the transaction prices of dwellings purchased by households
purchase prices means the prices actually paid by purchasers for products, including any taxes less subsidies on the products, after the deduction of discounts from standard prices or charges, excluding interest or services charges added under credit arrangements and any extra charges incurred as a result of failing to pay within the period specified at the time of purchase
administered prices means prices that are either directly set or influenced to a significant extent by the government
harmonised index of consumer prices or HICP means the comparable index of consumer prices produced by each Member State
harmonised index of consumer prices at constant tax rates or HICP-CT means the index that measures changes in consumer prices without the impact of changes in tax rates on products over the same period of time
tax rate means a tax parameter and may be a certain percentage of the price or an absolute tax amount levied on a physical unit
owner-occupied housing price index or OOH price index means the index that measures changes in the transaction prices of dwellings new to the household sector and of other products that the households acquire in their role as owner-occupiers
house price index or HPI means the index that measures changes in the transaction prices of dwellings purchased by households
sub-index of the HICP or the HICP-CT means the price index for any category of the European classification of individual consumption according to purpose (ECOICOP) as set out in Annex I
harmonised indices means the HICP, the HICP-CT, the OOH price index and the HPI
flash estimate of the HICP means an early estimate of the HICP provided by Member States whose currency is the euro that may be based on provisional information and, if necessary, appropriate modelling
Laspeyres-type index means the price index that measures the average change in prices from the price reference period to a comparison period using expenditure shares from a period prior to the price reference period, and where the expenditure shares are adjusted to reflect the prices of the price reference period.
A ‘Laspeyres-type index’ is defined as:
Formula
The price of a product is denoted by p, the price reference period is denoted by 0, and the comparison period is denoted by t. Weights (w) are expenditure shares of a period (b) prior to the price reference period, and are adjusted to reflect the prices of the price reference period 0
index reference period means the period for which the index is set to 100 index points
price reference period means the period to which the price of the comparison period is compared; for monthly indices, the price reference period is December of the previous year, and for quarterly indices, the price reference period is the fourth quarter of the previous year
basic information means data covering:
(a) with reference to the HICP and the HICP-CT:
(i) purchase prices of products which need to be taken into account in order to compute sub-indices in accordance with this Regulation;
(ii) characteristics that determine the product price;
(iii) information on taxes and excise duties levied;
(iv) information as to whether a price is fully or partially administered; and
(v) weights reflecting the level and structure of the consumption of the products concerned;
(b) with reference to the OOH price index:
(i) transaction prices of dwellings new to the household sector and of other products that the households acquire in their role as owner-occupiers which need to be taken into account to compute the OOH price index in accordance with this Regulation;
(ii) characteristics which determine the dwelling price and the prices of other products that the households acquire in their role as owner-occupiers; and
(iii) weights reflecting the level and structure of the relevant housing expenditure categories;
(c) with reference to the HPI:
(i) transaction prices of dwellings purchased by households which need to be taken into account to compute the HPI in accordance with this Regulation;
(ii) characteristics which determine the dwelling price; and
(iii) weights reflecting the level and structure of the relevant housing expenditure categories
household means a household as referred to in points (a) and (b) of paragraph 2.119 of Annex A to ESA 2010, irrespective of nationality or residence status
economic territory of the Member State means the economic territory as referred to in paragraph 2.05 of Annex A to ESA 2010, with the exception that the extraterritorial enclaves situated within the boundaries of the Member State are included and the territorial enclaves situated in the rest of the world are excluded
household final monetary consumption expenditure means that part of final consumption expenditure incurred:
— by households,
— in monetary transactions,
— on the economic territory of the Member State,
— on products that are used for the direct satisfaction of individual needs or wants, as defined in paragraph 3.101 of Annex A to ESA 2010,
— in one or both of the time periods being compared
significant change in the production method means a change that is estimated to affect the annual rate of change of a given harmonised index or part thereof in any period by more than:
(a) 0,1 percentage points for the all-items HICP, HICP-CT, OOH price index or HPI;
(b) 0,3, 0,4, 0,5 or 0,6 percentage points for any ECOICOP division, group, class or subclass (5-digit), respectively, for the HICP or the HICP-CT
Purchasing Power Parities (PPPs) shall mean spatial deflators and currency converters that eliminate the effects of the differences in price levels between Member States thus allowing volume comparisons of GDP components and comparisons of price levels
Purchasing Power Standard (PPS) shall mean the artificial common reference currency unit used in the European Union to express the volume of economic aggregates for the purpose of spatial comparisons in such a way that price level differences between Member States are eliminated
Prices shall mean the purchaser prices paid by the final consumers
Expenditure weights shall mean the shares of expenditure components in current-price GDP
Basic heading shall mean the lowest level of aggregation of items in the GDP breakdown for which parities are calculated
Items shall mean goods or services precisely defined for use in price observation
Temporal adjustment factors shall mean factors used to adjust average prices obtained at the time of survey to annual average prices
Spatial adjustment factors shall mean factors used to adjust average prices obtained from one or more locations within the economic territory of a Member State to national average prices
Representative items shall mean those which are, or are considered to be, in terms of relative total expenditure within a basic heading, among the most important items purchased in national markets
Representativity indicators shall mean markers or other indicators identifying those items that Member States have selected as representative
Equi-representativity hall mean a property required of the composition of the item list for a basic heading, each Member State being able to price that number of representative products which is commensurate with the heterogeneity of the products and price levels covered by the basic heading and its expenditure on the basic heading
Transitive shall mean the property whereby a direct comparison between any two Member States yields the same result as an indirect comparison via any other Member State
Mistake shall mean a use of incorrect basic information or an inappropriate application of the calculation procedure
Reference year shall mean a calendar year to which specific annual results refer
Fixity shall mean that when results are calculated originally for a group of Member States and then later the results are calculated for a wider group of Member States, the PPPs between the original group of Member States shall nevertheless be preserved
statistical unit means the basic observation unit, namely a natural person, household, family, living quarter, or conventional dwelling
individual enumeration means that information on each statistical unit is obtained so that their characteristics can be recorded separately and cross-classified with other characteristics
simultaneity means that the information obtained in a census refers to the same point in time (reference date)
universality within a defined territory means that data are provided for all statistical units within a precisely defined territory. Where statistical units are persons, ‘universality within a defined territory’ means that data are provided which are based on information for all persons that have their usual residence in the defined territory (total population)
availability of small-area data means the availability of data for small geographic areas and for small groups of statistical units
defined periodicity means the capacity to conduct censuses regularly at the beginning of every decade, including the continuity of registers
target population means the set of all statistical units in a defined geographical area at the reference date which qualify for reporting on one or more specified topics. The target population includes each valid statistical unit exactly once
estimated target population means the best available approximation of the target population. The estimated target population consists of the census population plus under-coverage minus over-coverage
census population means the set of statistical units which is factually represented by the census results on one or more specified topics for a specified target population. The data records for the census population are the data records in the data source for the specified target population, including all imputed records and excluding all deleted records. If a data source comprises, as a matter of methodological principle, data records for only a sample of the statistical units in its estimated target population, the census population comprises, in addition to the statistical units in the sample, the complementary set of statistical units
complementary set of statistical units means the set of those statistical units that belong to an estimated target population, but about which the data source contains no data records as a result of an applied sampling methodology
coverage assessment means a study of the difference between a specified target population and its census population
post-enumeration survey means a survey conducted shortly after the enumeration for coverage and content assessment purposes
under-coverage means the set of all statistical units that belong to a specified target population, but are not included in the corresponding census population
over-coverage means the set of all statistical units that are included in a census population used to report on a specified target population without belonging to that target population
record imputation means the assignment of an artificial but plausible data record to exactly one geographical area at the most detailed geographical level for which census data are produced, and the imputation of that data record into a data source
record deletion means the act of deleting or ignoring a data record that is included in a data source used to report on a specified target population, but does not report any valid information on any statistical unit within that target population
item imputation means the insertion of artificial but plausible information into a data record where the data record already exists in a data source but does not contain this information
data source means the set of data records for statistical units and/or events related to statistical units which forms a basis for the production of census data about one or more specified topics for a specified target population
register-based data means data that are in or originate from a register
questionnaire-based data means data that are originally obtained from respondents by the means of a questionnaire in the context of a collection of statistical data which refer to a specified point in time
register means a repository which stores information about statistical units and is directly updated in the course of events affecting the statistical units
record linkage means the process of merging information from different data sources by comparing the records for the individual statistical units and merging the information for each statistical unit where the unit to which the records refer is the same
matching of registers means a record linkage where all matched data sources are contained in registers
data extraction means the process of retrieving census information from information contained in a register and relating to individual statistical units
coding means the process of converting information into codes representing classes within a classification scheme
identifying variable means a variable in the data records in a data source or any list of statistical units which is used
— to evaluate whether the data source (or list of statistical units) includes no more than one data record for each statistical unit, and/or
— for a record linkage
capturing means the process by which collected data are put into a machine-readable form
record editing means the process of checking and modifying data records to make them plausible while at the same time preserving major parts of these records
generation of a household means the identification of a private household according to the household-dwelling concept as defined in the Annex to Regulation (EC) No 1201/2009 under the topic ‘Household status’
generation of a family means the identification of a family based on information on whether the persons live in the same household, but with no or incomplete information on family relationships between persons. The term ‘family’ is specified as ‘family nucleus’ in the Annex to Regulation (EC) No 1201/2009 under the topic ‘Family status’
unit no-information means the failure to collect any data from a statistical unit that is in the census population
item no-information means the failure to collect data on one or more specified topics for a statistical unit that is in the census population, while data on at least one other topic can be collected for that statistical unit
statistical disclosure control means the methods and processes applied in order to minimise the risk of disclosing information on individual statistical units while releasing as much statistical information as possible
estimation means the calculation of statistics or estimates using a mathematical formula and/or algorithm applied to the available data
coefficient of variation means the standard error (square root of the variance of an estimator) divided by the expected value of the estimator
model assumption error means an error due to assumptions underlying the estimation and containing uncertainty or lack of detail
data structure definition means a set of structural metadata associated with a data set, which includes information about how concepts are associated with the measures, dimensions, and attributes of a hypercube, along with information about the representation of data and related descriptive metadata
employee s a person who works in a ‘paid employment’ job, that is a job where the explicit or implicit contract of employment gives the incumbent a basic remuneration, which is independent of the revenue of the unit for which he/she works (this unit may be a corporation, a non-profit institution, government unit or a household). Persons in ‘paid employment’ jobs are typically remunerated by wages and salaries, but may be paid by commission from sales, by piece rates, bonuses or in-kind payment such as food, housing or training. Some or all of the tools, capital equipment, information systems and/or premises used by the incumbent may be owned by others, and the incumbent may work under direct supervision of, or according to strict guidelines set by, the owner(s) or persons in the owners’ employment
employer is a person who, working on his or her own account or with a small number of partners, holds a ‘self-employment’ job and, in this capacity, on a continuous basis (including the reference week) has engaged one or more persons to work for him/her as ‘employees’. The incumbent makes the operational decisions affecting the enterprise, or delegates such decisions while retaining responsibility for the welfare of the enterprise
own-account worker is a person who, working on his/her own account or with one or a few partners, holds a ‘self-employment job’ and has not engaged, on a continuous basis (including the reference week), any ‘employees’
contributing family worker is a person who
— holds a ‘self-employment’ job in a market-oriented establishment operated by a related person, living in the same household, and
— cannot be regarded as a partner (that is an employer or own-account worker) because the degree of commitment to the operation of the establishment, in terms of working time or other factors to be determined by national circumstances, is not at a level comparable to that of the head of the establishment
member of a producers’ cooperative is a person who holds a ‘self-employment’ job in an establishment organised as a cooperative, in which each member takes part on an equal footing with other members in determining the organisation of production, sales and/or other work, the investments and the distribution of the proceeds among the members
Primary homeless persons are persons living in the streets without a shelter that would fall within the scope of living quarters as defined in the technical specifications for the topic ‘Type of living quarters’
Conventional dwellings are structurally separate and independent premises at fixed locations which are designed for permanent human habitation and are, at the reference date,
(a) used as a residence, or
(b) vacant, or
(c) reserved for seasonal or secondary use
Separate means surrounded by walls and covered by a roof or ceiling so that one or more persons can isolate themselves
Independent means having direct access from a street or a staircase, passage, gallery or grounds
Other housing units are huts, cabins, shacks, shanties, caravans, houseboats, barns, mills, caves or any other shelter used for human habitation at the time of the census, irrespective if it was designed for human habitation
Collective living quarters are premises which are designed for habitation by large groups of individuals or several households and which are used as the usual residence of at least one person at the time of the census
Occupied conventional dwellings are conventional dwellings which are the usual residence of one or more persons at the time of the census
Unoccupied conventional dwellings are conventional dwellings which are not the usual residence of any person at the time of the census
Owner-occupied dwellings are those where at least one occupant of the dwelling owns parts or the whole of the dwelling
Rented dwellings are those where at least one occupant pays a rent for the occupation of the dwelling, and where no occupant owns parts or the whole of the dwelling
inside information means information of a precise nature which has not been made public, which relates, directly or indirectly, to one or more wholesale energy products and which, if it were made public, would be likely to significantly affect the prices of those wholesale energy products
information means:
(a) information which is required to be made public in accordance with Regulations (EC) No 714/2009 and (EC) No 715/2009, including guidelines and network codes adopted pursuant to those Regulations;
(b) information relating to the capacity and use of facilities for production, storage, consumption or transmission of electricity or natural gas or related to the capacity and use of LNG facilities, including planned or unplanned unavailability of these facilities;
(c) information which is required to be disclosed in accordance with legal or regulatory provisions at Union or national level, market rules, and contracts or customs on the relevant wholesale energy market, in so far as this information is likely to have a significant effect on the prices of wholesale energy products; and
(d) other information that a reasonable market participant would be likely to use as part of the basis of its decision to enter into a transaction relating to, or to issue an order to trade in, a wholesale energy product.
Information shall be deemed to be of a precise nature if it indicates a set of circumstances which exists or may reasonably be expected to come into existence, or an event which has occurred or may reasonably be expected to do so, and if it is specific enough to enable a conclusion to be drawn as to the possible effect of that set of circumstances or event on the prices of wholesale energy products
market manipulation means:
(a) entering into any transaction or issuing any order to trade in wholesale energy products which:
(i) gives, or is likely to give, false or misleading signals as to the supply of, demand for, or price of wholesale energy products;
(ii) secures or attempts to secure, by a person, or persons acting in collaboration, the price of one or several wholesale energy products at an artificial level, unless the person who entered into the transaction or issued the order to trade establishes that his reasons for doing so are legitimate and that that transaction or order to trade conforms to accepted market practices on the wholesale energy market concerned; or
(iii) employs or attempts to employ a fictitious device or any other form of deception or contrivance which gives, or is likely to give, false or misleading signals regarding the supply of, demand for, or price of wholesale energy products;
or
(b)
disseminating information through the media, including the internet, or by any other means, which gives, or is likely to give, false or misleading signals as to the supply of, demand for, or price of wholesale energy products, including the dissemination of rumours and false or misleading news, where the disseminating person knew, or ought to have known, that the information was false or misleading.
When information is disseminated for the purposes of journalism or artistic expression, such dissemination of information shall be assessed taking into account the rules governing the freedom of the press and freedom of expression in other media, unless:
(i) those persons derive, directly or indirectly, an advantage or profits from the dissemination of the information in question; or
(ii) the disclosure or dissemination is made with the intention of misleading the market as to the supply of, demand for, or price of wholesale energy products
attempt to manipulate the market means:
(a) entering into any transaction, issuing any order to trade or taking any other action relating to a wholesale energy product with the intention of:
(i) giving false or misleading signals as to the supply of, demand for, or price of wholesale energy products;
(ii) securing the price of one or several wholesale energy products at an artificial level, unless the person who entered into the transaction or issued the order to trade establishes that his reasons for doing so are legitimate and that that transaction or order to trade conforms to accepted market practices on the wholesale energy market concerned; or
(iii) employing a fictitious device or any other form of deception or contrivance which gives, or is likely to give, false or misleading signals regarding the supply of, demand for, or price of wholesale energy products;
or
(b) disseminating information through the media, including the internet, or by any other means with the intention of giving false or misleading signals as to the supply of, demand for, or price of wholesale energy products
wholesale energy products means the following contracts and derivatives, irrespective of where and how they are traded:
(a) contracts for the supply of electricity or natural gas where delivery is in the Union;
(b) derivatives relating to electricity or natural gas produced, traded or delivered in the Union;
(c) contracts relating to the transportation of electricity or natural gas in the Union;
(d) derivatives relating to the transportation of electricity or natural gas in the Union.
Contracts for the supply and distribution of electricity or natural gas for the use of final customers are not wholesale energy products. However, contracts for the supply and distribution of electricity or natural gas to final customers with a consumption capacity greater than the threshold set out in the second paragraph of point (5) shall be treated as wholesale energy products
consumption capacity means the consumption of a final customer of either electricity or natural gas at full use of that customer's production capacity. It comprises all consumption by that customer as a single economic entity, in so far as consumption takes place on markets with interrelated wholesale prices.
For the purposes of this definition, consumption at individual plants under the control of a single economic entity that have a consumption capacity of less than 600 GWh per year shall not be taken into account in so far as those plants do not exert a joint influence on wholesale energy market prices due to their being located in different relevant geographical markets
wholesale energy market means any market within the Union on which wholesale energy products are traded
market participant means any person, including transmission system operators, who enters into transactions, including the placing of orders to trade, in one or more wholesale energy markets
competent financial authority means a competent authority designated in accordance with the procedure laid down in Article 11 of Directive 2003/6/EC
transmission system operator has the meaning set out in point 4 of Article 2 of Directive 2009/72/EC and in point 4 of Article 2 of Directive 2009/73/EC
related undertaking means either a subsidiary or other undertaking in which a participation is held, or an undertaking linked with another undertaking by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC
goods means all movable property, including electricity
statistical territory of the Community means the ‘customs territory of the Community’ as defined in the Customs Code with the addition of the Island of Heligoland in the territory of the Federal Republic of Germany
national statistical authorities means the national statistical institutes and other bodies responsible in each Member State for producing external trade statistics
decision by customs means any official act by customs authorities relating to accepted customs declarations and having legal effect on one or more persons
agricultural products means products listed in Annex I to the Treaty, with the exception of fishery products
processing of agricultural products means any operation on an agricultural product resulting in a product which is also an agricultural product, except on-farm activities necessary for preparing an animal or plant product for the first sale
marketing of agricultural products means holding or display with a view to sale, offering for sale, delivery or any other manner of placing on the market, except the first sale by a primary producer to resellers or processors and any activity preparing a product for such first sale; a sale by a primary producer to final consumers shall be considered as marketing if it takes place in separate premises reserved for that purpose
food enzyme means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms:
(i) containing one or more enzymes capable of catalyzing a specific biochemical reaction; and
(ii) added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods
food enzyme preparation means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution
hazard class means the nature of the physical, health or environmental hazard
hazard category means the division of criteria within each hazard class, specifying hazard severity
hazard pictogram means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned
signal word means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:
(a) ‘Danger’ means a signal word indicating the more severe hazard categories;
(b) ‘Warning’ means a signal word indicating the less severe hazard categories
hazard statement means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard
precautionary statement means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal
substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition
mixture means a mixture or solution composed of two or more substances
article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition
producer of an article means any natural or legal person who makes or assembles an article within the Community
polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:
(a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
(b) less than a simple weight majority of molecules of the same molecular weight.
In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer
monomer means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process
registrant means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006
manufacturing means production or extraction of substances in the natural state
manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community
import means the physical introduction into the customs territory of the Community
importer means any natural or legal person established within the Community who is responsible for import
placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market
downstream user means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user
distributor means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties
intermediate means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance
non-isolated intermediate means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture
the Agency means the European Chemicals Agency established by Regulation (EC) No 1907/2006
competent authority means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation
use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation
supplier means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture
alloy means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation
UN RTDG means the United Nations Recommendations on the Transport of Dangerous Goods
notifier means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency
scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions
cut-off value means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified
concentration limit means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively
differentiation means distinction within hazard classes depending on the route of exposure or the nature of the effects
M-factor means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present
package means the complete product of the packing operation, consisting of the packaging and its contents
packaging means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions
intermediate packaging means packaging placed between inner packaging, or articles, and outer packaging
Gas means a substance which:
(i) at 50 oC has a vapour pressure greater than 300 kPa (absolute); or
(ii) is completely gaseous at 20 oC at a standard pressure of 101,3 kPa
Liquid means a substance or mixture which:
(i) at 50 oC has a vapour pressure of not more than 300 kPa (3 bar);
(ii) is not completely gaseous at 20 oC and at a standard pressure of 101,3 kPa; and
(iii) which has a melting point or initial melting point of 20 oC or less at a standard pressure of 101,3 kPa
Solid means a substance or mixture which does not meet the definitions of liquid or gas
Flammable gas means a gas or gas mixture having a flammable range with air at 20 oC and a standard pressure of 101,3 kPa
Chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen
Aerosols, this means aerosol dispensers are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state
Explosive substance or mixture is a solid or liquid substance or mixture of substances which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases
Pyrotechnic substance or mixture is a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of non-detonative self-sustaining exothermic chemical reactions
Unstable explosive is an explosive substance or mixture which is thermally unstable and/or too sensitive for normal handling, transport and use
Explosive article is an article containing one or more explosive substances or mixtures
Pyrotechnic article is an article containing one or more pyrotechnic substances or mixtures
Intentional explosive is a substance, mixture or article which is manufactured with a view to producing a practical, explosive or pyrotechnic effect
Flammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa
Chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen
Oxidising gas means any gas or gas mixture which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does
Gases under pressure are gases which are contained in a receptacle at a pressure of 200 kPa (gauge) or more at 20 °C, or which are liquefied or liquefied and refrigerated. They comprise compressed gases, liquefied gases, dissolved gases and refrigerated liquefied gases
Critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression
Flammable liquid means a liquid having a flash point of not more than 60 oC
Flammable solid means a solid which is readily combustible, or may cause or contribute to fire through friction
Self-reactive substances or mixtures are thermally unstable liquid or solid substances or mixtures liable to undergo a strongly exothermic decomposition even without participation of oxygen (air). This definition excludes substances and mixtures classified according to this Part as explosives, organic peroxides or as oxidising
Pyrophoric liquid means a liquid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air
Pyrophoric solid means a solid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air
Self-heating substance or mixture is a liquid or solid substance or mixture, other than a pyrophoric liquid or solid, which, by reaction with air and without energy supply, is liable to self-heat; this substance or mixture differs from a pyrophoric liquid or solid in that it will ignite only when in large amounts (kilograms) and after long periods of time (hours or days)
Self-heating of a substance or a mixture is a process where the gradual reaction of that substance or mixture with oxygen (in the air) generates heat. If the rate of heat production exceeds the rate of heat loss, then the temperature of the substance or mixture will rise which, after an induction time, may lead to self-ignition and combustion
Substances or mixtures which, in contact with water, emit flammable gases means solid or liquid substances or mixtures which, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases in dangerous quantities
Oxidising liquid means a liquid substance or mixture which, while in itself not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material
Oxidising solid means a solid substance or mixture which, while in itself is not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material
Organic peroxides means liquid or solid organic substances which contain the bivalent -O-O- structure and may be considered derivatives of hydrogen peroxide, where one or both of the hydrogen atoms have been replaced by organic radicals. The term organic peroxide includes organic peroxide mixtures (formulations) containing at least one organic peroxide. Organic peroxides are thermally unstable substances or mixtures, which can undergo exothermic self-accelerating decomposition. In addition, they can have one or more of the following properties:
(i) be liable to explosive decomposition;
(ii) burn rapidly;
(iii) be sensitive to impact or friction;
(iv) react dangerously with other substances
Substance or a mixture that is corrosive to metals means a substance or a mixture which by chemical action will materially damage, or even destroy, metals
Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours
dust solid particles of a substance or mixture suspended in a gas (usually air)
mist liquid droplets of a substance or mixture suspended in a gas (usually air)
vapour the gaseous form of a substance or mixture released from its liquid or solid state
Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions
Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours
Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application
Respiratory sensitiser means a substance that will lead to hypersensitivity of the airways following inhalation of the substance
Skin sensitiser means a substance that will lead to an allergic response following skin contact
Mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations)
Carcinogen means a substance or a mixture of substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans
Specific target organ toxicity (single exposure) specific, non lethal target organ toxicity arising from a single exposure to a substance or mixture
Target organ toxicity (repeated exposure) means specific, target organ toxicity arising from a repeated exposure to a substance or mixture
Aspiration means the entry of a liquid or solid substance or mixture directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system
acute aquatic toxicity means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance
short-term (acute) hazard means for classification purposes the hazard of a substance or mixture caused by its acute toxicity to an organism during short-term aquatic exposure to that substance or mixture
availability of a substance means the extent to which this substance becomes a soluble or disaggregate species. For metal availability, the extent to which the metal ion portion of a metal (M°) compound can disaggregate from the rest of the compound (molecule)
bioavailability or biological availability means the extent to which a substance is taken up by an organism, and distributed to an area within the organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability
bioaccumulation means the net result of uptake, transformation and elimination of a substance in an organism due to all routes of exposure (i.e. air, water, sediment/soil and food)
bioconcentration means the net result of uptake, transformation and elimination of a substance in an organism due to waterborne exposure
chronic aquatic toxicity means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism
degradation means the decomposition of organic molecules to smaller molecules and eventually to carbon dioxide, water and salts
ECx means the effect concentration associated with x% response
long-term (chronic) hazard means for classification purposes the hazard of a substance or mixture caused by its chronic toxicity following long-term exposure in the aquatic environment
no observed effect concentration (NOEC) means the test concentration immediately below the lowest tested concentration with statistically significant adverse effect. The NOEC has no statistically significant adverse effect compared to the control
Ozone depleting potential (ODP) is an integrative quantity, distinct for each halocarbon source species, that represents the extent of ozone depletion in the stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio of integrated perturbations to total ozone, for a differential mass emission of a particular compound relative to an equal emission of CFC-11
Substance hazardous to the ozone layer means a substance which, on the basis of the available evidence concerning its properties and its predicted or observed environmental fate and behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes substances which are listed in Annex I to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer
Mixture for consumer use means a mixture intended to be used by consumers
Mixture for professional use means a mixture intended to be used by professional users but not at industrial sites
Mixture for industrial use means a mixture intended to be used at industrial sites only
electronic money institution means a legal person that has been granted authorisation under Title II to issue electronic money
electronic money means electronically, including magnetically, stored monetary value as represented by a claim on the issuer which is issued on receipt of funds for the purpose of making payment transactions as defined in point 5 of Article 4 of Directive 2007/64/EC, and which is accepted by a natural or legal person other than the electronic money issuer
electronic money issuer means entities referred to in Article 1(1), institutions benefiting from the waiver under Article 1(3) and legal persons benefiting from a waiver under Article 9
average outstanding electronic money means the average total amount of financial liabilities related to electronic money in issue at the end of each calendar day over the preceding six calendar months, calculated on the first calendar day of each calendar month and applied for that calendar month
credit institution means an undertaking the business of which is to receive deposits or other repayable funds from the public and to grant credits for its own account
financial institution means an undertaking other than a credit institution, the principal activity of which is to acquire holdings or to pursue one or more of the activities listed in points 2 to 12 and 15 of Annex I
channel means a numerical designator used in conjunction with voice communication equipment tuning, which allows unique identification of the applicable radio frequency and associated channel spacing
8,33 kHz channel spacing means a channel spacing where the nominal channel centre frequencies are separated in increments of 8,33 kHz
radio means any installed, portable or handheld device designed to transmit and/or receive transmissions in the VHF band
central register means a register where the national frequency manager registers the necessary operational, technical and administrative details for each frequency assignment in accordance with Regulation (EU) No 677/2011
8,33 kHz conversion means the replacement of a frequency assignment registered in the central register and using 25 kHz channel spacing by a frequency assignment using 8,33 kHz channel spacing
frequency assignment means authorisation given by a Member State to use a radio frequency or radio frequency channel under specified conditions for the purpose of operating radio equipment
operator means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation
flights operated under visual flight rules means any flights operated under visual flight rules as defined in Annex 2 to the 1944 Chicago Convention on International Civil Aviation (‘the Chicago Convention’)
State aircraft means any aircraft used by military, customs or police
offset carrier operation means a case where the designated operational coverage cannot be ensured by a single ground transmitter and where, in order to minimise the interference problems, the signals from two or more ground transmitters are offset from the nominal channel centre frequency
aircraft radio equipment means one or more radios located on board an aircraft and used by an authorised flight crew member during flight
radio upgrade means the replacement of a radio by a radio of a different model or part number
designated operational coverage means the volume of airspace in which a particular service is provided and in which the service is afforded frequency protection
air traffic control unit (ATC unit) means area control centre, approach control unit or aerodrome control tower
working position means the furniture and technical equipment at which a member of the air traffic services (‘ATS’) staff undertakes the tasks associated with his operational responsibilities
radio-telephony means a form of radio-communication primarily intended for the exchange of information in the form of speech
letter of agreement means an agreement between two adjacent ATS units that specifies how their respective ATS responsibilities are to be coordinated
Integrated Initial Flight Plan Processing System (IFPS) means a system within the European Air Traffic Management Network through which a centralised flight planning processing and distribution service, dealing with the reception, validation and distribution of flight plans, is provided within the airspace covered by this Regulation
transport-type State aircraft means fixed wing State aircraft that are designed for the purpose of transporting persons and/or cargo
operational control communication means communication carried out by aircraft operators, which also affect air transport safety, regularity and efficiency of flights
relevant operator means:
(a) an investment firm operating a multilateral trading facility (MTF);
(b) an investment firm operating an organised trading facility (OTF);
(c) a market operator operating an MTF;
(d) a market operator operating an OTF
inert waste means waste that does not undergo any significant physical, chemical or biological transformations. Inert waste will not dissolve, burn or otherwise physically or chemically react, biodegrade or adversely affect other matter with which it comes into contact in a way likely to give rise to environmental pollution or harm human health. The total leachability and pollutant content of the waste and the ecotoxicity of the leachate must be insignificant, and in particular not endanger the quality of surface water and/or groundwater
underground storage means a permanent waste storage facility in a deep geological cavity such as a salt or potassium mine
landfill means a waste disposal site for the deposit of the waste onto or into land (i.e. underground), including:
— internal waste disposal sites (i.e. landfill where a producer of waste is carrying out its own waste disposal at the place of production), and
— a permanent site (i.e. more than one year) which is used for temporary storage of waste,
but excluding:
— facilities where waste is unloaded in order to permit its preparation for further transport for recovery, treatment or dispsal elsewhere, and
— stoarage of waste prior to recovery or treatment for a period less than three years as a general rule, or
— storage of waste prior to disposal for a period less than one year
treatment means the physical, thermal, chemical or biological processes, including sorting, that change the characteristics of the waste in order to reduce its volume or hazardous nature, facilitate its handling or enhance recovery
leachate means any liquid percolating through the deposited waste and emitted from or contained within a landfill
landfill gas means all the gases generated from the landfilled waste
eluate means the solution obtained by a laboratory leaching test
operator means the natural or legal person responsible for a landfill in accordance with the internal legislation of the Member State where the landfill is located; this person may change from the preparation to the after-care phase
biodegradable waste means any waste that is capable of undergoing anaerobic or aerobic decomposition, such as food and garden waste, and paper and paperboard
applicant means any person who applies for a landfill permit under this Directive
competent authority means that authority which the Member States designate as responsible for performing the duties arising from this Directive
liquid waste means any waste in liquid form including waste waters but excluding sludge
isolated settlement means a settlement:
— with no more than 500 inhabitants per municipality or settlement and no more than five inhabitants per square kilometre and,
— where the distance to the nearest urban agglomeration with at least 250 inhabitants per square kilometre is not less than 50 km, or with difficult access by road to those nearest agglomerations, due to harsh meteorological conditions during a significant part of the year.
In outermost regions within the meaning of Article 349 of the Treaty, Member States may decide to apply the following definition:
‘isolated settlement’ means a settlement:
— with no more than 2 000 inhabitants per settlement and no more than five inhabitants per square kilometre, or with more than 2 000 but less than 5 000 inhabitants per settlement and no more than five inhabitants per square kilometre and whose production of waste does not exceed 3 000 tonnes per year, and
— where the distance to the nearest urban agglomeration with at least 250 inhabitants per square kilometre is not less than 100 km and with no access by road
surveillance data means any data item, time stamped or not, within the surveillance system that pertains to:
(a) aircraft 2D position;
(b) aircraft vertical position;
(c) aircraft attitude;
(d) aircraft identity;
(e) 24-bit ICAO aircraft address;
(f) aircraft intent;
(g) aircraft velocity;
(h) aircraft acceleration
operator means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation
ADS-B means automatic dependent surveillance — broadcast, a surveillance technique in which aircraft automatically provide, via a data link, data derived from on-board navigation and position-fixing systems
ADS-B Out means the provision of ADS-B surveillance data from an aircraft transmit perspective
harmful interference means interference that prevents the achievement of the performance requirements
surveillance chain means a system composed of the aggregation of airborne and ground-based constituents used to determine the respective surveillance data items of aircraft, including the surveillance data processing system, if deployed
cooperative surveillance chain means a surveillance chain requiring both ground and airborne components to determine surveillance data items
surveillance data processing system means a system that processes all surveillance inputs received to form a best estimate of the current aircraft surveillance data
aircraft identification means a group of letters, figures or a combination thereof which is either identical to, or the coded equivalent of, the aircraft call sign to be used in air-to-ground communications, and which is used to identify the aircraft in ground-to-ground air traffic services communications
State aircraft means any aircraft used for military, customs and police purposes
transport type State aircraft means fixed wing State aircraft that are designed for the purpose of transporting persons and/or cargo
extrapolate means to project, predict or extend known data based upon values within an already observed time interval
coasted means extrapolated for a period longer than the ground surveillance systems update period
time of applicability means the time at which the data item has been measured by the surveillance chain or the time for which it has been calculated by the surveillance chain
accuracy means the degree of conformity of the provided value of a data item with its actual value at the time when the data item is output from the surveillance chain
availability means the degree to which a system or component is operational and accessible when required for use
integrity means the degree of undetected (at system level) non-conformity of the input value of the data item with its output value
continuity means the probability that a system will perform its required function without unscheduled interruption, assuming that the system is available at the initiation of the intended operation
timeliness means the difference between the time of output of a data item and the time of applicability of that data item
institution for occupational retirement provision or IORP means an institution, irrespective of its legal form, operating on a funded basis, established separately from any sponsoring undertaking or trade for the purpose of providing retirement benefits in the context of an occupational activity on the basis of an agreement or a contract agreed:
(a) individually or collectively between the employer(s) and the employee(s) or their respective representatives, or
(b) with self-employed persons, individually or collectively, in compliance with the law of the home and host Member States,
and which carries out activities directly arising therefrom
pension scheme means a contract, an agreement, a trust deed or rules stipulating which retirement benefits are granted and under which conditions
sponsoring undertaking means any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which offers a pension scheme or pays contributions to an IORP
retirement benefits means benefits paid by reference to reaching, or the expectation of reaching, retirement or, where they are supplementary to those benefits and provided on an ancillary basis, in the form of payments on death, disability, or cessation of employment or in the form of support payments or services in case of sickness, indigence or death. In order to facilitate financial security in retirement, these benefits may take the form of payments for life, payments made for a temporary period, a lump sum, or any combination thereof
member means a person, other than a beneficiary or a prospective member, whose past or current occupational activities entitle or will entitle him/her to retirement benefits in accordance with the provisions of a pension scheme
beneficiary means a person receiving retirement benefits
prospective member means a person who is eligible to join a pension scheme
competent authority means a national authority designated to carry out the duties provided for in this Directive
biometric risks mean risks linked to death, disability and longevity
home Member State means the Member State in which the IORP has been registered or authorised and in which its main administration is located in accordance with Article 9
host Member State means the Member State whose social and labour law relevant to the field of occupational pension schemes is applicable to the relationship between the sponsoring undertaking and members or beneficiaries
transferring IORP means an IORP transferring all or a part of a pension scheme's liabilities, technical provisions, and other obligations and rights, as well as corresponding assets or cash equivalent thereof, to an IORP registered or authorised in another Member State
receiving IORP means an IORP receiving all or a part of a pension scheme's liabilities, technical provisions, and other obligations and rights, as well as corresponding assets or cash equivalent thereof, from an IORP registered or authorised in another Member State
durable medium means an instrument which enables a member or a beneficiary to store information addressed personally to that member or beneficiary in a way that is accessible for future reference and for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored
key function within a system of governance, means a capacity to undertake practical tasks comprising the risk management function, the internal audit function, and the actuarial function
cross-border activity means operating a pension scheme where the relationship between the sponsoring undertaking, and the members and beneficiaries concerned, is governed by the social and labour law relevant to the field of occupational pension schemes of a Member State other than the home Member State
Mode S interrogator means a system, composed of antenna and electronics, supporting addressing of individual aircraft through the Mode Select, known as Mode S
interrogator code means either an interrogator identifier or a surveillance identifier code used for multisite lockout and possibly communication protocols
interrogator identifier code (II code) means a Mode S interrogator code with a value in the range from 0 to 15 that can be used for both multisite lockout and communications protocols
surveillance identifier code (SI code) means a Mode S interrogator code with a value in the range from 1 to 63 that can be used for multisite lockout protocols, but cannot be used for multisite communications protocols
multisite lockout means the protocol that allows Mode S target acquisition and lockout by several Mode S interrogators that have overlapping coverage
multisite communications protocols means the protocols used to coordinate, in areas of overlapping Mode S interrogators coverage, the control of communications performed in more than one transaction
Mode S target means a platform equipped with a Mode S transponder
lockout means the protocol that allows the suppression of Mode S all call replies from already acquired Mode S targets
Mode S operator means a person, organisation or enterprise operating or offering to operate a Mode S interrogator, including:
(a) air navigation service providers;
(b) Mode S interrogators manufacturers;
(c) airport operators;
(d) research establishments;
(e) any other entity entitled to operate a Mode S interrogator
interrogator code allocation means a definition of values for at least all the key items of an interrogator code allocation as listed in Annex II, Part B
interrogator code allocation system means a system within the European Air Traffic Management Network, and the associated procedures, through which a centralised service of interrogator code allocation (hereinafter interrogator code allocation service), dealing with the processing of interrogator code applications and the distribution of an interrogator code allocation plan proposal, is provided to Mode S operators through Member States
interrogator code application means an application from a Mode S operator for the allocation of an interrogator code
interrogator code allocation plan proposal means a proposal for a complete set of IC allocations, submitted by the interrogator code allocation service for approval by Member States
interrogator code allocation plan means the most recently approved complete set of interrogator code allocations
eligible Mode S interrogator means a Mode S interrogator for which at least one of the following conditions is satisfied:
(a) the interrogator relies, at least partly, on Mode S all call interrogations and replies for Mode S targets acquisition; or
(b) the interrogator locks out acquired Mode S targets in reply to Mode S all call interrogations, permanently or intermittently, in part or totality of its coverage; or
(c) the interrogator uses multisite communications protocols for data link applications
eligible interrogator code means any code among the II codes and the SI codes, except:
(a) II code 0;
(b) the interrogator code(s) reserved for military entities, including intergovernmental organisations in particular North Atlantic Treaty Organisation management and allocation
Mode S all call interrogations means the messages that are normally used by Mode S interrogators to acquire Mode S targets entering their coverage area
operational interrogator code means any eligible interrogator code other than II code 14
competent Member State means:
(a) in the case of an air navigation service provider, the Member State that has certified the provider in accordance with Commission Regulation (EC) No 2096/2005;
(b) in other cases, the Member State within the area of responsibility of which the Mode S operator operates, or intends to operate, an eligible Mode S interrogator
interrogator code conflict means uncoordinated coverage overlap of two or more Mode S interrogators operating on the same interrogator code, potentially resulting in aircraft remaining undetected by at least one of the Mode S interrogators
monitoring of interrogator code conflict means the implementation, by a Mode S operator, of technical or procedural means, for identifying the effects of interrogator code conflicts with other Mode S interrogators on the surveillance data provided by its own Mode S interrogators
implementation sequence means the time-bounded sequence of implementation of interrogator code allocations with which Mode S operators need to comply to avoid temporary interrogator code conflicts
matching II code means the II code decoded by a Mode S transponder not supporting SI codes, in a Mode S all call interrogation containing an SI code, and which is used by this transponder to encode the all call reply
lockout map means the Mode S interrogator configuration file defining where and how to apply lockout to Mode S targets
data link service means a set of related air traffic management transactions, supported by air-ground data link communications, which have a clearly defined operational goal and begin and end on an operational event
operator means a person, organisation or enterprise engaged in, or offering to engage in, an aircraft operation
air traffic services unit (ATS unit) means a unit, civil or military, responsible for providing air traffic services
service level agreement means that part of a service contract between organisations in which a certain level of service is agreed, in particular in relation to the quality and performance of the data communications service
air–ground point-to-point data communication means a two-way communication between an aircraft and a ground communication entity relying upon a set of distributed functions to achieve:
(a) the transmission and reception of uplink and downlink bit frames over a mobile data link between ground and aircraft communication systems;
(b) the transmission and reception of data units between ground and aircraft systems hosting the air-ground applications with:
(i) the relay of data units throughout ground communication paths and mobile data links;
(ii) the cooperative mechanisms of both ends for the transport of data units
State aircraft means any aircraft used for military, customs and police
transport type State aircraft means fixed wing State aircraft that are designed for the purpose of transporting persons and/or cargo
air-ground application means a set of cooperative air-ground functions in support of air traffic services
end-to-end communication means the transfer of information between peer air-ground applications
air-ground communication means a two-way communication between aircraft and ground communication systems
security policy means a set of objectives, rules of behaviour for users and administrators, and requirements for system configuration and management that collectively are designed to safeguard systems and communication resources concerned with the provision of data link services against acts of unlawful interference
addressing information means information pertaining to the system or network address of an entity participating in air-ground data link communication and enabling the location of the entity to be unambiguously determined
integrated initial flight plan processing system (IFPS) means a system within the European Air Traffic Management Network through which a centralised flight planning processing and distribution service, dealing with the reception, validation and distribution of flight plans, is provided within the airspace covered by this Regulation
inoperative in relation to an airborne constituent means that the constituent does not accomplish its intended purpose or is not consistently functioning within its operating limits or tolerances
civil aviation means any air operation carried out by civil aircraft, excluding operations carried out by State aircraft referred to in Article 3 of the Chicago Convention on International Civil Aviation
aviation security means the combination of measures and human and material resources intended to safeguard civil aviation against acts of unlawful interference that jeopardise the security of civil aviation
operator means a person, organisation or enterprise engaged, or offering to engage, in an air transport operation
air carrier means an air transport undertaking holding a valid operating licence or equivalent
Community air carrier means an air carrier holding a valid operating licence granted by a Member State in accordance with Council Regulation (EEC) No 2407/92 of 23 July 1992 on licensing of air carrier
entity means a person, organisation or enterprise, other than an operator
prohibited articles means weapons, explosives or other dangerous devices, articles or substances that may be used to commit an act of unlawful interference that jeopardises the security of civil aviation
screening means the application of technical or other means which are intended to identify and/or detect prohibited articles
security control means the application of means by which the introduction of prohibited articles may be prevented
access control means the application of means by which the entry of unauthorised persons or unauthorised vehicles, or both, may be prevented
airside means the movement area of an airport, adjacent terrain and buildings or portions thereof, access to which is restricted
landside means those parts of an airport, adjacent terrain and buildings or portions thereof that are not airside
security restricted area means that area of airside where, in addition to access being restricted, other aviation security standards are applied
demarcated area means an area that is separated by means of access control either from security restricted areas, or, if the demarcated area itself is a security restricted area, from other security restricted areas of an airport
background check means a recorded check of a person’s identity, including any criminal history, as part of the assessment of an individual’s suitability for unescorted access to security restricted areas
transfer passengers, baggage, cargo or mail means passengers, baggage, cargo or mail departing on an aircraft other than that on which they arrived
transit passengers, baggage, cargo or mail means passengers, baggage, cargo or mail departing on the same aircraft as that on which they arrived
potentially disruptive passenger means a passenger who is either a deportee, a person deemed to be inadmissible for immigration reasons or a person in lawful custody
cabin baggage means baggage intended for carriage in the cabin of an aircraft
hold baggage means baggage intended for carriage in the hold of an aircraft
accompanied hold baggage means baggage, carried in the hold of an aircraft, which has been checked in for a flight by a passenger travelling on that same flight
air carrier mail means mail whose origin and destination are both an air carrier
air carrier materials means materials either whose origin and destination are both an air carrier or that are used by an air carrier
mail means dispatches of correspondence and other items, other than air carrier mail, tendered by and intended for delivery to postal services in accordance with the rules of the Universal Postal Union
cargo means any property intended for carriage on an aircraft, other than baggage, mail, air carrier mail, air carrier materials and in-flight supplies
regulated agent means an air carrier, agent, freight forwarder or any other entity who ensures security controls in respect of cargo or mail
known consignor means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of cargo or mail on any aircraft
account consignor means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of that cargo on all-cargo aircraft or mail on all-mail aircraft
aircraft security check means an inspection of those parts of the interior of the aircraft to which passengers may have had access, together with an inspection of the hold of the aircraft in order to detect prohibited articles and unlawful interferences with the aircraft
aircraft security search means an inspection of the interior and accessible exterior of the aircraft in order to detect prohibited articles and unlawful interferences that jeopardise the security of the aircraft
in-flight security officer means a person who is employed by a state to travel on an aircraft of an air carrier licensed by it with the purpose of protecting that aircraft and its occupants against acts of unlawful interference that jeopardise the security of the flight
annual traffic volume means the total number of passengers arriving, departing and in transit (counted once)
appropriate authority means the national authority designated by a Member State pursuant to Article 9 to be responsible for the coordination and monitoring of the implementation of its national civil aviation security programme
auditor means any person conducting national compliance monitoring activities on behalf of the appropriate authority
certification means a formal evaluation and confirmation by or on behalf of the appropriate authority that a person possesses the necessary competencies to perform the functions of an auditor to an acceptable level as defined by the appropriate authority
compliance monitoring activities means any procedure or process used for assessing the implementation of this Regulation and the national aviation security programme
deficiency means a failure to comply with an aviation security requirement
inspection means an examination of the implementation of security measures and procedures in order to determine whether they are being carried out effectively and to the required standard and to identify any deficiencies
interview means an oral check by an auditor to establish whether specific security measures or procedures are implemented
observation means a visual check by an auditor that a security measure or procedure is implemented
representative sample means a selection made from amongst possible options for monitoring which is sufficient in number and range to provide a basis for general conclusions on implementing standards
security audit means an in-depth examination of security measures and procedures in order to determine if they are being fully implemented on a continual basis
test means a trial of aviation security measures, where the appropriate authority simulates intent to commit an act of unlawful interference for the purpose of examining the effectiveness of the implementation of existing security measures
verification means an action taken by an auditor to establish whether a specific security measure is actually in place
vulnerability means any weakness in the implemented measures and procedures which could be exploited to carry out an act of unlawful interference
index means any figure:
(a) that is published or made available to the public;
(b) that is regularly determined:
(i) entirely or partially by the application of a formula or any other method of calculation, or by an assessment; and
(ii) on the basis of the value of one or more underlying assets or prices, including estimated prices, actual or estimated interest rates, quotes and committed quotes, or other values or surveys
index provider means a natural or legal person that has control over the provision of an index
benchmark means any index by reference to which the amount payable under a financial instrument or a financial contract, or the value of a financial instrument, is determined, or an index that is used to measure the performance of an investment fund with the purpose of tracking the return of such index or of defining the asset allocation of a portfolio or of computing the performance fees
family of benchmarks means a group of benchmarks provided by the same administrator and determined from input data of the same nature which provides specific measures of the same or similar market or economic reality
provision of a benchmark means:
(a) administering the arrangements for determining a benchmark;
(b) collecting, analysing or processing input data for the purpose of determining a benchmark; and
(c) determining a benchmark through the application of a formula or other method of calculation or by an assessment of input data provided for that purpose
administrator means a natural or legal person that has control over the provision of a benchmark
use of a benchmark means:
(a) issuance of a financial instrument which references an index or a combination of indices;
(b) determination of the amount payable under a financial instrument or a financial contract by referencing an index or a combination of indices;
(c) being a party to a financial contract which references an index or a combination of indices;
(d) providing a borrowing rate as defined in point (j) of Article 3 of Directive 2008/48/EC calculated as a spread or mark-up over an index or a combination of indices and that is solely used as a reference in a financial contract to which the creditor is a party;
(e) measuring the performance of an investment fund through an index or a combination of indices for the purpose of tracking the return of such index or combination of indices, of defining the asset allocation of a portfolio, or of computing the performance fees
contribution of input data means providing any input data not readily available to an administrator, or to another person for the purposes of passing to an administrator, that is required in connection with the determination of a benchmark, and is provided for that purpose
contributor means a natural or legal person contributing input data
supervised contributor means a supervised entity that contributes input data to an administrator located in the Union
submitter means a natural person employed by the contributor for the purpose of contributing input data
assessor means an employee of an administrator of a commodity benchmark, or any other natural person whose services are placed at the administrator's disposal or under the control of the administrator, and who is responsible for applying a methodology or judgement to input data and other information to reach a conclusive assessment about the price of a certain commodity
expert judgement means the exercise of discretion by an administrator or a contributor with respect to the use of data in determining a benchmark, including extrapolating values from prior or related transactions, adjusting values for factors that might influence the quality of data such as market events or impairment of a buyer or seller's credit quality, and weighting firm bids or offers greater than a particular concluded transaction
input data means the data in respect of the value of one or more underlying assets, or prices, including estimated prices, quotes, committed quotes or other values, used by an administrator to determine a benchmark
transaction data means observable prices, rates, indices or values representing transactions between unaffiliated counterparties in an active market subject to competitive supply and demand forces
financial instrument means any of the instruments listed in Section C of Annex I to Directive 2014/65/EU for which a request for admission to trading on a trading venue, as defined in point (24) of Article 4(1) of Directive 2014/65/EU, has been made or which is traded on a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU or via a systematic internaliser as defined in point (20) of Article 4(1) of that Directive
supervised entity means any of the following:
(a) a credit institution as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council;
(b) an investment firm as defined in point (1) of Article 4(1) of Directive 2014/65/EU;
(c) an insurance undertaking as defined in point (1) of Article 13 of Directive 2009/138/EC of the European Parliament and of the Council;
(d) a reinsurance undertaking as defined in point (4) of Article 13 of Directive 2009/138/EC;
(e) a UCITS as defined in Article 1(2) of Directive 2009/65/EC or, where applicable, a UCITS management company as defined in point (b) of Article 2(1) of that Directive;
(f) an alternative investment fund manager (AIFM) as defined in point (b) of Article 4(1) of Directive 2011/61/EU of the European Parliament and of the Council;
(g) an institution for occupational retirement provision as defined in point (a) of Article 6 of Directive 2003/41/EC of the European Parliament and of the Council;
(h) a creditor as defined in point (b) of Article 3 of Directive 2008/48/EC for the purposes of credit agreements as defined in point (c) of Article 3 of that Directive;
(i) a non-credit institution as defined in point (10) of Article 4 of Directive 2014/17/EU for the purposes of credit agreements as defined in point (3) of Article 4 of that Directive;
(j) a market operator as defined in point (18) of Article 4(1) of Directive 2014/65/EU;
(k) a CCP as defined in point (1) of Article 2 of Regulation (EU) No 648/2012 of the European Parliament and of the Council;
(l) a trade repository as defined in point (2) of Article 2 of Regulation (EU) No 648/2012;
(m) an administrator
financial contract means:
(a) any credit agreement as defined in point (c) of Article 3 of Directive 2008/48/EC;
(b) any credit agreement as defined in point (3) of Article 4 of Directive 2014/17/EU
investment fund means an AIF as defined in point (a) of Article 4(1) of Directive 2011/61/EU, or a UCITS as defined in Article 1(2) of Directive 2009/65/EC
management body means the body or bodies of an administrator or another supervised entity which are appointed in accordance with national law, which are empowered to set the strategy, objectives and overall direction of the administrator or other supervised entity, and which oversee and monitor management decision-making and include persons who effectively direct the business of the administrator or other supervised entity
consumer means a natural person who, in financial contracts covered by this Regulation, is acting for purposes which are outside his or her trade, business or profession
interest rate benchmark means a benchmark which for the purposes of point (1)(b)(ii) of this paragraph is determined on the basis of the rate at which banks may lend to, or borrow from, other banks, or agents other than banks, in the money market
commodity benchmark means a benchmark where the underlying asset for the purposes of point (1)(b)(ii) of this paragraph is a commodity within the meaning of point (1) of Article 2 of Commission Regulation (EC) No 1287/2006, excluding emission allowances as referred to in point (11) of Section C of Annex I to Directive 2014/65/EU
EU Climate Transition Benchmark means a benchmark which is labelled as an EU Climate Transition Benchmark and fulfils the following requirements:
(a) for the purposes of point 1(b)(ii) of this paragraph and of Article 19b, its underlying assets are selected, weighted or excluded in such a manner that the resulting benchmark portfolio is on a decarbonisation trajectory; and
(b) it is constructed in accordance with the minimum standards laid down in the delegated acts referred to in Article 19a(2)
EU Paris-aligned Benchmark means a benchmark which is labelled as an EU Paris-aligned Benchmark and fulfils the following requirements:
(a) for the purposes of point 1(b)(ii) of this paragraph and of the delegated act referred to in Article 19c, its underlying assets are selected, weighted or excluded in such a manner that the resulting benchmark portfolio’s carbon emissions are aligned with the objectives of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change, approved by the Union on 5 October 2016 ( 7 ) (the ‘Paris Agreement’);
(b) it is constructed in accordance with the minimum standards laid down in the delegated acts referred to in Article 19a(2); and
(c) the activities relating to its underlying assets do not significantly harm other environmental, social and governance (ESG) objectives
decarbonisation trajectory means a measurable, science-based and time-bound trajectory towards alignment with the objectives of the Paris Agreement by reducing Scope 1, 2 and 3 carbon emissions as referred to in point (1)(e) of Annex III
regulated-data benchmark means a benchmark determined by the application of a formula from:
(a) input data contributed entirely and directly from:
(i) a trading venue as defined in point (24) of Article 4(1) of Directive 2014/65/EU or a trading venue in a third country for which the Commission has adopted an implementing decision that the legal and supervisory framework of that country is considered to have equivalent effect within the meaning of Article 28(4) of Regulation (EU) No 600/2014 of the European Parliament and of the Council ( 8 ), or a regulated market considered to be equivalent under Article 2a of Regulation (EU) No 648/2012, but in each case only with reference to transaction data concerning financial instruments;
(ii) an approved publication arrangement as defined in point (52) of Article 4(1) of Directive 2014/65/EU or a consolidated tape provider as defined in point (53) of Article 4(1) of Directive 2014/65/EU, in accordance with mandatory post-trade transparency requirements, but only with reference to transaction data concerning financial instruments that are traded on a trading venue;
(iii) an approved reporting mechanism as defined in point (54) of Article 4(1) of Directive 2014/65/EU, but only with reference to transaction data concerning financial instruments that are traded on a trading venue and that must be disclosed in accordance with mandatory post-trade transparency requirements;
(iv) an electricity exchange as referred to in point (j) of Article 37(1) of Directive 2009/72/EC of the European Parliament and of the Council;
(v) a natural gas exchange as referred to in point (j) of Article 41(1) of Directive 2009/73/EC of the European Parliament and of the Council;
(vi) an auction platform referred to in Article 26 or 30 of Commission Regulation (EU) No 1031/2010;
(vii) a service provider to which the benchmark administrator has outsourced the data collection in accordance with Article 10, provided that the service provider receives the data entirely and directly from an entity referred to in points (i) to (vi);
(b) net asset values of investment funds
critical benchmark means a benchmark other than a regulated-data benchmark that fulfils any of the conditions laid down in Article 20(1) and which is on the list established by the Commission pursuant to that Article
significant benchmark means a benchmark that fulfils the conditions laid down in Article 24(1)
non-significant benchmark means a benchmark that does not fulfil the conditions laid down in Articles 20(1) and 24(1)
located means, in relation to a legal person, the country where that person's registered office or other official address is situated and, in relation to a natural person, the country where that person is resident for tax purposes
public authority means:
(a) any government or other public administration, including the entities charged with or intervening in the management of the public debt;
(b) any entity or person either performing public administrative functions under national law or having public responsibilities or functions or providing public services, including measures of employment, economic activities and inflation, under the control of an entity within the meaning of point (a)
notification means the transmission by the transferring unit of data to update the system at the receiving unit in preparation for the coordination
coordination means the coordination between air traffic control units of the planned passage of flights across the common boundary, in order to ensure flight safety
air traffic control unit (ATC unit) means variously area control centre, approach control unit or aerodrome control tower
civil-military coordination means the coordination between civil and military parties authorised to make decisions and agree a course of actio
flight data processing system means the part of an air traffic services system which receives, automatically processes and distributes to air traffic control units working positions, flight plan data and associated messages
air traffic services unit (ATS unit) means a unit, civil or military, responsible for providing air traffic services
controlling military unit means any fixed or mobile military unit handling military air traffic and/or pursuing other activities that due to their specific nature may require airspace reservation or restriction
transferring unit means the air traffic control unit in the process of transferring the responsibility for providing an air traffic control service to an aircraft to the next ATC unit along the route of flight
receiving unit means the air traffic control unit who receives data
boundary means a lateral or vertical plane delineating the airspace in which an ATC unit provides air traffic services
area control centre (ACC) means a unit established to provide air traffic control service to controlled flights in control areas under its responsibility
working position means the furniture and technical equipment at which a member of the air traffic services staff undertakes task associated with their job
flight plan means specified information provided to air traffic services units, relative to an intended flight or portion of a flight of an aircraft
warning means a message displayed at a working position when the automated coordination process has failed
estimate data means the coordination point, the estimated time of an aircraft and the expected flight level of the aircraft at the coordination point
secondary surveillance radar (SSR) means a surveillance radar system which uses transmitters or receivers and transponders
letter of agreement means an agreement between two adjacent ATC units that specifies how their respective ATC responsibilities are to be coordinated
transfer of control point means a point on the flight path of an aircraft, at which the responsibility for providing air traffic services to the aircraft is transferred from one ATC unit to the next
coordination data mean data of interest to operational staff in connection with the process of notification, coordination and transfer of flights and with the process of civil-military coordination
transfer flight level means the flight level agreed during the coordination if in level flight, or the cleared flight level to which the flight is proceeding if climbing or descending at the coordination point
accepting unit means the air traffic control unit next to take control of an aircraft
coordination point (COP) means a point on or adjacent to the boundary used by the ATC units and referred to in coordination processes
notified unit means the ATC unit that has received the notification information
correlation means the process of linking the flight plan data and the radar track of the same flight
release means the authorising by the controller transferring an aircraft of a controller at the accepting unit to issue control instructions to the aircraft prior to its passing the transfer of control point
availability means the degree to which a system or component is operational and accessible when required for use
reliability means the probability that the ground installation operates within the specified tolerances
aid means any measure fulfilling all the criteria laid down in Article 107(1) of the Treaty
small and medium-sized undertakings or SMEs means undertakings fulfilling the criteria laid down in Annex I
natural disasters means earthquakes, avalanches, landslides and floods, tornadoes, hurricanes, volcanic eruptions and wild fires of natural origin
undertaking in difficulty means an undertaking in respect of which at least one of the following circumstances occurs:
(a) in the case of a limited liability company (other than an SME that has been in existence for less than three years), where more than half of its subscribed share capital has disappeared as a result of accumulated losses. This is the case when deduction of accumulated losses from reserves (and all other elements generally considered as part of the own funds of the company) leads to a negative cumulative amount that exceeds half of the subscribed share capital. For the purposes of this provision, ‘limited liability company’ refers in particular to the types of company mentioned in Annex I of Directive 2013/34/EU of the European Parliament and of the Council (17) and ‘share capital’ includes, where relevant, any share premium;
(b) in the case of a company where at least some members have unlimited liability for the debt of the company (other than an SME that has been in existence for less than three years), where more than half of its capital as shown in the company accounts has disappeared as a result of accumulated losses. For the purposes of this provision, ‘a company where at least some members have unlimited liability for the debt of the company’ refers in particular to the types of company mentioned in Annex II to Directive 2013/34/EU;
(c) where the undertaking is subject to collective insolvency proceedings or fulfils the criteria under its domestic law for being placed in collective insolvency proceedings at the request of its creditors;
(d) where the undertaking has received rescue aid and has not yet reimbursed the loan or terminated the guarantee, or has received restructuring aid and is still subject to a restructuring plan
ad hoc aid means aid not granted on the basis of an aid scheme
aid scheme means any act on the basis of which, without further implementing measures being required, individual aid awards may be made to undertakings defined within the act in a general and abstract manner and any act on the basis of which aid which is not linked to a specific project may be granted to one or several undertakings for an indefinite period of time and/or for an indefinite amount
individual aid means:
(a) ad hoc aid; and
(b) awards of aid to individual beneficiaries on the basis of an aid scheme
gross grant equivalent means the amount of the aid if it had been provided in the form of a grant to the beneficiary, before any deduction of tax or other charges
repayable advance means a loan for a project which is paid in one or more instalments and the conditions for the reimbursement of which depend on the outcome of the project
start of works means the earlier of either the start of construction works relating to the investment, or the first legally binding commitment to order equipment or any other commitment that makes the investment irreversible. Buying land and preparatory works such as obtaining permits and conducting feasibility studies are not considered start of works. For take-overs, ‘start of works’ means the moment of acquiring assets directly linked to the acquired establishment
fiscal successor scheme means a scheme in the form of tax advantages which constitutes an amended version of a previously existing scheme in the form of tax advantages and which replaces it
aid intensity means the gross aid amount expressed as a percentage of the eligible costs, before any deduction of tax or other charge
date of granting the aid means the date when the legal right to receive the aid is conferred on the beneficiary under the applicable national legal regime
request for assistance means a request addressed by one Member State to another Member State for:
(a) information;
(b) enforcement measures; or
(c) administrative notification.
PMSE means wireless video links that can be portable or mobile and cordless cameras, used for programme making and special events.
e.i.r.p. means equivalent isotropically radiated power, which is the product of the power supplied to the antenna and the antenna gain in a given direction relative to an isotropic antenna (absolute or isotropic gain).
all stages of the production, processing and distribution means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer
introduction means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code
official veterinarian means a veterinarian qualified to act in that capacity appointed by the competent authority
products of animal origin means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use
animal means any animal of the Suidae family, excluding feral pigs as defined in Article 2(b) of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever
holding means any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled
keeper means any natural or legal person responsible, even on a temporary basis, for animals
competent authority means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive
pressure equipment means vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs
vessel means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber
piping means piping components intended for the transport of fluids, when connected together for integration into a pressure system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping
safety accessories means devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices
pressure accessories means devices with an operational function and having pressure-bearing housings
assemblies means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole
pressure means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value
maximum allowable pressure PS means the maximum pressure for which the equipment is designed, as specified by the manufacturer, and defined at a location specified by him, being either the connection of protective and/or limiting devices, or the top of equipment or, if not appropriate, any point specified
maximum/minimum allowable temperature TS means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer
volume (V) means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts
nominal size (DN) means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size; it is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN followed by a number
fluids means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension of solids
permanent joints means joints which cannot be disconnected except by destructive methods
European approval for materials means a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonised standard
making available on the market means any supply of pressure equipment or assemblies for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of pressure equipment or assemblies on the Union market
putting into service means the first use of pressure equipment or an assembly by its user
manufacturer means any natural or legal person who manufactures pressure equipment or an assembly or has such equipment or assembly designed or manufactured, and markets that pressure equipment or assembly under his name or trademark or uses it for his own purposes
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
importer means any natural or legal person established within the Union who places pressure equipment or assemblies from a third country on the Union market
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment or assemblies available on the market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
technical specification means a document that prescribes technical requirements to be fulfilled by pressure equipment or assemblies
conformity assessment eans the process demonstrating whether the essential safety requirements of this Directive relating to pressure equipment or assemblies have been fulfilled
conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection
recall means any measure aimed at achieving the return of pressure equipment or assemblies that have already been made available to consumers or other users
withdrawal means any measure aimed at preventing pressure equipment or assemblies in the supply chain from being made available on the market
CE marking means a marking by which the manufacturer indicates that the pressure equipment or assembly is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products
Veterinary medicinal product (a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
(b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis
Substance Any matter irrespective of origin which may be:
— human, e.g.
— human blood and human blood products;
— animal, e.g.
— micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
— vegetable, e.g.
— micro-organisms, plants, parts of plants, vegetable secretions, extracts;
— chemical, e.g.
— elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis
Pre-mix for medicated feedingstuffs Any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs
Medicated feedingstuffs Any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by point 2
Immunological veterinary medicinal product A veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity
Homeopathic veterinary medicinal product Any veterinary medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in Member States. A homeopathic veterinary medicinal product may contain a number of principles
Withdrawal period The period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of this Directive, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to Regulation (EEC) No 2377/90
Adverse reaction A reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function
Human adverse reaction A reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine
Serious adverse reaction An adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated
Unexpected adverse reaction An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics
Periodic safety update reports The periodical reports containing the records referred to in Article 75
Post-marketing surveillance studies Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product
Off-label use The use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product
Wholesale dealing in veterinary medicinal products Any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for:
— the supply by a manufacturer of veterinary medicinal products manufactured by himself,
— retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with Article 66
Representative of the marketing authorisation holder The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned
Agency The European Medicines Agency established by Regulation (EC) No 726/2004
Risks relating to use of the product — any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health;
— any risk of undesirable effects on the environment
Risk/benefit balance An evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above
Veterinary prescription Any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law
Name of veterinary medicinal product The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder
Common name The international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name
Strength The content of active substances, expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form
Immediate packaging The container or any other form of packaging that is in direct contact with the medicinal product
Outer packaging The packaging into which is placed the immediate packaging
Labelling Information on the immediate or outer packaging
Package leaflet he leaflet containing information for the user that accompanies the medicinal product
generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information intended to provide proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines
Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
feed law means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Union or national level at any stage of production, processing and distribution or use of feed
competent authorities means:
(a) the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2);
(b) any other authority to which that responsibility has been conferred;
(c) where appropriate, the corresponding authorities of a third country
organic control authority means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007, including, where appropriate, the corresponding authority of a third country or operating in a third country
delegated body means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities
control verification procedures means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective
control system means a system comprising the competent authorities and the resources, structures, arrangements and procedures set up in a Member State to ensure that official controls are performed in accordance with this Regulation and with the rules referred to in Articles 18 to 27
control plan means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2)
goods means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals
hazard means any agent or condition with the potential to have an adverse effect on human, animal or plant health, animal welfare or the environment
risk means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard
official certification means the procedure by which assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2) is provided by the competent authorities
certifying officer means:
(a) any official of the competent authorities authorised to sign official certificates by such authorities; or
(b) any other natural person who is authorised by the competent authorities to sign official certificates in accordance with the rules referred to in Article 1(2)
official certificate means a paper or electronic document signed by the certifying officer and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2)
official attestation means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in this Regulation or in the rules referred to in Article 1(2)
operator means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2)
audit means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives
rating means a classification of operators based on an assessment of their conformity with rating criteria
official veterinarian means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2)
official plant health officer means a natural person appointed by a competent authority, either as staff or otherwise, and appropriately trained to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in point (g) of Article 1(2)
consignment means a number of animals or quantity of goods covered by the same official certificate, official attestation or any other document, conveyed by the same means of transport and coming from the same territory or third country, and, except for goods subject to the rules referred to in point (g) of Article 1(2), being of the same type, class or description
border control post means a place, and the facilities belonging to it, designated by a Member State for the performance of the official controls provided for in Article 47(1)
exit point means a border control post or any other place designated by a Member State where animals, falling within the scope of Regulation (EC) No 1/2005, leave the customs territory of the Union
entering the Union or entry into the Union means the action of bringing animals and goods into one of the territories that are listed in Annex I to this Regulation from outside these territories, except in relation to the rules referred to in point (g) of Article 1(2) for which these terms mean the action of bringing goods into the ‘Union territory’ as defined in the second subparagraph of Article 1(3) of Regulation (EU) 2016/2031
documentary check means the examination of the official certificates, official attestations and other documents including documents of a commercial nature, which are required to accompany the consignment as provided for by the rules referred to in Article 1(2), by Article 56(1) or by implementing acts adopted in accordance with Articles 77(3), 126(3), 128(1) and 129(1)
identity check means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond to the information provided in the official certificates, official attestations and other documents accompanying it
physical check means a check on animals or goods and, as appropriate, checks on packaging, the means of transport, labelling and temperature, the sampling for analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2)
transit means movement from one third country to another third country passing under customs supervision through one of the territories listed in Annex I or from one of the territories listed in Annex I to another territory listed in Annex I after passing through the territory of a third country, except in relation to the rules referred to in point (g) of Article 1(2), for which it means one of the following;
(a) movement from one third country to another third country, as defined in the first subparagraph of Article 1(3) of Regulation (EU) 2016/2031 passing under customs supervision through the ‘Union territory’, as defined in the second subparagraph of Article 1(3) of that Regulation; or
(b) movement from the ‘Union territory’ to another part of the ‘Union territory’, as defined in the second subparagraph of Article 1(3) of Regulation (EU) 2016/2031, passing through the territory of a third country as defined in the first subparagraph of Article 1(3) of that Regulation
official detention’ means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities
official auxiliary means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities
health mark means a mark applied after the official controls referred to in points (a) and (c) of Article 18(2) have been performed and which attests that the meat is fit for human consumption
under the responsibility of the official veterinarian means that the official veterinarian assigns the performance of an action to an official auxiliary
under the supervision of the official veterinarian means that an action is performed by an official auxiliary under the responsibility of the official veterinarian and the official veterinarian is present on the premises during the time necessary to perform that action
ante-mortem inspection means the verification, prior to slaughtering activities, of human and animal health and animal welfare requirements, including, where appropriate, the clinical examination of each individual animal, and the verification of the food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004
post-mortem inspection means the verification in the slaughterhouse or game-handling establishment of compliance with requirements applicable to:
(i) carcases as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004 and offal as defined in point 1.11 of that Annex, for the purpose of deciding if the meat is fit for human consumption,
(ii) safe removal of specified risk material, and
(iii) the health and welfare of the animal
holding means any establishment, construction or, in the case of an open-air farm, any place situated within the territory of the same Member State, in which animals covered by this Regulation are held, kept or handled
keeper means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis, including during transportation or at a market
competent authority means the central authority or authorities in a Member State responsible for, or entrusted with, carrying out veterinary checks and implementing this title or, in the case of the monitoring of premiums, the authorities entrusted with implementing Regulation (EC) No 3508/92
beef means all products falling within CN codes 0201 , 0202 , 0206 10 95 and 0206 29 91
labelling means the attachment of a label to an individual piece or pieces of meat or to their packaging material, or, in the case of non-pre-wrapped products, the supply of appropriate information in written and visible form to the consumer at the point of sale
organisation means a group of operators from the same or different parts of the beef trade
minced meat means any boned meat that has been minced into fragments and contains less than 1 % salt and that falls within CN codes 0201 , 0202 , 0206 10 95 and 0206 29 91
trimmings means small pieces of meat recognised as fit for human consumption produced exclusively during trimming operations during the boning of carcasses and/or the cutting up of meat
cut meat means meat which has been cut into small cubes, slices or other individual portions that do not require further cutting by an operator before being bought by the final consumer and that can be directly used by that consumer. This definition does not cover minced meat and trimmings
applicant means a natural person or an entity with or without legal personality who has submitted an application in a grant award procedure or in a contest for prizes
application document means a tender, a request to participate, a grant application or an application in a contest for prizes
award procedure means a procurement procedure, a grant award procedure, a contest for prizes, or a procedure for the selection of experts or persons or entities implementing the budget pursuant to point (c) of the first subparagraph of Article 62(1)
basic act means a legal act, other than a recommendation or an opinion, which provides a legal basis for an action and for the implementation of the corresponding expenditure entered in the budget or of the budgetary guarantee or financial assistance backed by the budget, and which may take any of the following forms:
(a) in implementation of the Treaty on the Functioning of the European Union (TFEU) and the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the form of a regulation, a directive or a decision within the meaning of Article 288 TFEU; or
(b) in implementation of Title V of the Treaty on European Union (TEU), one of the forms specified in Articles 28(1) and 31(2), Article 33, and Articles 42(4) and 43(2) TEU
beneficiary means a natural person or an entity with or without legal personality with whom a grant agreement has been signed
blending facility or platform means a cooperation framework established between the Commission and development or other public finance institutions with a view to combining non-repayable forms of support and/or financial instruments and/or budgetary guarantees from the budget and repayable forms of support from development or other public finance institutions, as well as from private-sector finance institutions and private-sector investors
budget implementation means the carrying out of activities relating to the management, monitoring, control and auditing of budget appropriations in accordance with the methods provided for in Article 62
budgetary commitment means the operation by which the authorising officer responsible reserves the budget appropriations necessary to cover subsequent payments to honour legal commitments
budgetary guarantee means a legal commitment of the Union to support a programme of actions by taking on the budget a financial obligation that can be called upon should a specified event materialise during the implementation of the programme, and that remains valid for the duration of the maturity of the commitments made under the supported programme
building contract means a contract covering the purchase, exchange, long lease, usufruct, leasing, rental or hire purchase, with or without option to buy, of land, buildings or other immovable property. It covers both existing buildings and buildings before completion provided that the candidate has obtained a valid building permit for it. It does not cover buildings designed in accordance with the specifications of the contracting authority that are covered by works contracts
candidate means an economic operator that has sought an invitation or has been invited to take part in a restricted procedure, a competitive procedure with negotiation, a competitive dialogue, an innovation partnership, a design contest or a negotiated procedure
central purchasing body means a contracting authority providing centralised purchasing activities and, where applicable, ancillary purchasing activities
check means the verification of a specific aspect of a revenue or expenditure operation
concession contract means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities within the meaning of Articles 174 and 178, in order to entrust the execution of works or the provision and management of services to an economic operator (the ‘concession’), and where:
(a) the remuneration consists either solely in the right to exploit the works or services or in that right together with payment;
(b) the award of the concession contract involves the transfer to the concessionaire of an operating risk in exploiting those works or services encompassing demand risk or supply risk, or both. The concessionaire shall be deemed to assume an operating risk where, under normal operating conditions, there is no guarantee of recouping the investments made or the costs incurred in operating the works or the services concerned
contingent liability means a potential financial obligation that could be incurred depending on the outcome of a future event
contract means a public contract or a concession contract
contractor means an economic operator with whom a public contract has been signed
contribution agreement means an agreement concluded with persons or entities implementing Union funds pursuant to points (c)(ii) to (viii) of the first subparagraph of Article 62(1)
control means any measure taken to provide reasonable assurance regarding the effectiveness, efficiency and economy of operations, the reliability of reporting, the safeguarding of assets and information, the prevention and detection and correction of fraud and irregularities and their follow-up, and the adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account the multiannual character of programmes as well as the nature of the payments concerned. Controls may involve various checks, as well as the implementation of any policies and procedures to achieve the objectives referred to in the first sentence
counterpart means the party that is granted a budgetary guarantee
crisis means:
(a) a situation of immediate or imminent danger threatening to escalate into an armed conflict or to destabilise a country or its neighbourhood;
(b) a situation caused by natural disasters, man-made crisis such as wars and other conflicts or extraordinary circumstances having comparable effects related, inter alia, to climate change, environmental degradation, privation of access to energy and natural resources or extreme poverty
decommitment means an operation whereby the authorising officer responsible cancels wholly or partly the reservation of appropriations previously made by means of a budgetary commitment
dynamic purchasing system means a completely electronic process for making commonly used purchases of items generally available on the market
economic operator means any natural or legal person, including a public entity, or a group of such persons, who offers to supply products, execute works or provide services or supply immovable property
equity investment means the provision of capital to a company, invested directly or indirectly in return for total or partial ownership of that company and where the equity investor may assume some management control of the company and may share the company’s profits
European office means an administrative structure set up by the Commission, or by the Commission with one or more other Union institutions, to perform specific cross-cutting tasks
final administrative decision means a decision of an administrative authority having final and binding effect in accordance with the applicable law
financial asset means any asset in the form of cash, an equity instrument of a publicly or privately held entity or a contractual right to receive cash or another financial asset from such entity
financial instrument means a Union measure of financial support provided from the budget to address one or more specific policy objectives of the Union which may take the form of equity or quasi-equity investments, loans or guarantees, or other risk-sharing instruments, and which may, where appropriate, be combined with other forms of financial support or with funds under shared management or funds of the European Development Fund (EDF)
financial liability means a contractual obligation to deliver cash or another financial asset to another entity
framework contract means a public contract concluded between one or more economic operators and one or more contracting authorities, the purpose of which is to establish the terms governing specific contracts under it to be awarded during a given period, in particular with regard to price and, where appropriate, the quantity envisaged
global provisioning means the total amount of resources deemed necessary over the entire lifetime of a budgetary guarantee as a result of applying the provisioning rate referred to in Article 211(1) to the amount of the budgetary guarantee authorised by the basic act referred to in point (b) of Article 210(1)
grant means a financial contribution by way of donation. Where such a contribution is provided under direct management, it shall be governed by Title VIII
guarantee means a written commitment to assume responsibility for all or part of a third party’s debt or obligation or for the successful performance by that third party of its obligations if an event occurs which triggers such guarantee, such as a loan default
guarantee on demand means a guarantee that must be honoured by the guarantor upon the counterpart’s demand, notwithstanding any deficiencies in the enforceability of the underlying obligation
in-kind contribution means non-financial resources made available free of charge by third parties to a beneficiary
legal commitment means an act whereby the authorising officer responsible enters into or establishes an obligation which results in subsequent payment or payments and the recognition of expenditure charged to the budget, and which includes specific agreements and contracts concluded under financial framework partnership agreements and framework contracts
leverage effect means the amount of reimbursable financing provided to eligible final recipients divided by the amount of the Union contribution
liquidity risk means the risk that a financial asset held in the common provisioning fund might not be sold during a certain period of time without incurring a significant loss
loan means an agreement which obliges the lender to make available to the borrower an agreed amount of money for an agreed period and under which the borrower is obliged to repay that amount within the agreed period
low value grant means a grant lower than or equal to EUR 60 000
Member State organisation means an entity established in a Member State as a public law body, or as a body governed by private law entrusted with a public service mission and provided with adequate financial guarantees from the Member State
method of implementation means any of the methods of budget implementation referred to in Article 62, that is direct management, indirect management and shared management
multi-donor action means any action where Union funds are pooled with at least one other donor
multiplier effect means the investment by eligible final recipients divided by the amount of the Union contribution
output means the deliverables generated by the action determined in accordance with sector-specific rules
participant means a candidate or tenderer in a procurement procedure, an applicant in a grant award procedure, an expert in a procedure for selection of experts, an applicant in a contest for prizes or a person or entity participating in a procedure for implementing Union funds pursuant to point (c) of the first subparagraph of Article 62(1)
prize means a financial contribution given as a reward following a contest. Where such a contribution is provided under direct management, it shall be governed by Title IX
procurement means the acquisition by means of a contract of works, supplies or services and the acquisition or rental of land, buildings or other immovable property, by one or more contracting authorities from economic operators chosen by those contracting authorities
procurement document means any document produced or referred to by the contracting authority to describe or determine elements of the procurement procedure, including:
(a) the publicity measures set out in Article 163;
(b) the invitation to tender;
(c) the tender specifications, including the technical specifications and the relevant criteria, or the descriptive documents in the case of a competitive dialogue;
(d) the draft contract
public contract means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities within the meaning of Articles 174 and 178, in order to obtain, against payment of a price paid in whole or in part from the budget, the supply of movable or immovable assets, the execution of works or the provision of services, comprising:
(a) building contracts;
(b) supply contracts;
(c) works contracts;
(d) service contracts
quasi-equity investment means a type of financing that ranks between equity and debt, having a higher risk than senior debt and a lower risk than common equity and which can be structured as debt, typically unsecured and subordinated and in some cases convertible into equity, or into preferred equity
recipient means a beneficiary, a contractor, a remunerated external expert or a person or entity receiving prizes or funds under a financial instrument or implementing Union funds pursuant to point (c) of the first subparagraph of Article 62(1)
repurchase agreement means the sale of securities for cash with an agreement to repurchase them on a specified future date, or on demand
research and technological development appropriation means an appropriation entered either in one of the titles of the budget relating to the policy areas linked to ‘Indirect research’ or ‘Direct research’ or in a chapter relating to research activities in another title
result means the effects of the implementation of an action determined in accordance with sector-specific rules
risk-sharing instrument means a financial instrument which allows for the sharing of a defined risk between two or more entities, where appropriate in exchange for an agreed remuneration
service contract means a contract covering all intellectual and non-intellectual services other than those covered by supply contracts, works contracts and building contracts
sound financial management means implementation of the budget in accordance with the principles of economy, efficiency and effectiveness
Staff Regulations means the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union laid down in Regulation (EEC, Euratom, ECSC) No 259/68
subcontractor means an economic operator that is proposed by a candidate or tenderer or contractor to perform part of a contract or by a beneficiary to perform part of the tasks co-financed by a grant
subscription means sums paid to bodies of which the Union is member, in accordance with the budgetary decisions and the conditions of payment established by the body concerned
supply contract means a contract covering the purchase, leasing, rental or hire purchase, with or without option to buy, of products, and which may include, as an incidental matter, siting and installation operations
technical assistance means, without prejudice to sector-specific rules, support and capacity-building activities necessary for the implementation of a programme or an action, in particular preparatory, management, monitoring, evaluation, audit and control activities
tenderer means an economic operator that has submitted a tender
Union means the European Union, the European Atomic Energy Community, or both, as the context may require
Union institution means the European Parliament, the European Council, the Council, the Commission, the Court of Justice of the European Union, the Court of Auditors, the European Economic and Social Committee, the Committee of the Regions, the European Ombudsman, the European Data Protection Supervisor or the European External Action Service (the ‘EEAS’); the European Central Bank shall not be considered to be a Union institution
vendor means an economic operator registered in a list of vendors to be invited to submit requests to participate in or submit tenders
volunteer means a person working on a non-compulsory basis for an organisation without being paid
work means the outcome of building or civil engineering works taken as a whole that is sufficient in itself to fulfil an economic or technical function
works contract means a contract covering either:
(a) the execution or both the execution and design of a work;
(b) the execution or both the execution and design of a work related to one of the activities referred to in Annex II to Directive 2014/24/EU; or
(c) the realisation, by whatever means, of a work corresponding to the requirements specified by the contracting authority exercising a decisive influence on the type or design of the work
Corporate sponsorship means an agreement by which a legal person supports in-kind an event or an activity for promotional or corporate social responsibility purposes
olive oil marketed means total quantity of olive oil and olive pomace oil of a relevant Member State that is consumed in that Member State or exported from that Member State
Batch shall mean a set of sales units which are produced, manufactured and packed in circumstances such that the oil contained in each sales unit is considered to be homogenous in terms of all analytical characteristics. The individuation of a batch must be done in accordance with Directive 2011/91/EU of the European Parliament and of the Council
Increment shall mean the quantity of oil contained in an immediate package and taken from a random point of the batch
Primary Sample for immediate packaging not exceeding 5 litres shall mean the number of increments taken from a batch and in agreement with Table 1
Primary Sample for immediate packaging exceeding 5 litres shall mean a representative part of the total increments, obtained by a process of reduction and in agreement with Table 2. The primary sample must be composed of various examples
Example of a primary sample shall mean each of the packages making up the primary sample
eggs for hatching means poultry eggs falling within subheadings 0407 00 11 and 0407 00 19 of the Combined Nomenclature intended for the production of chicks, classified according to species, category and type and identified in accordance with this Regulation, produced in the Community or imported from third countries
chicks means live farmyard poultry the weight of which does not exceed 185 grammes, either produced in the Community or imported from third countries and falling within subheadings 0105 11 and 0105 19 of the Combined Nomenclature, of the following categories:
(a) utility chicks: chicks of one of the following types:
(i) table type chicks: chicks intended to be fattened and slaughtered before reaching sexual maturity;
(ii) laying chicks: chicks intended to be raised with a view to the production of eggs for consumption;
(iii) dual-purpose chicks: chicks intended either for laying or for the table;
(b) parent stock chicks: chicks intended for the production of utility chicks;
(c) grandparent stock chicks: chicks intended for the production of parent stock chicks
establishment means the establishment or part of an establishment for each of the following sectors of activity:
(a) pedigree breeding establishment: an establishment for the production of eggs for hatching intended for the production of grandparent stock, parent stock or utility chicks;
(b) breeding establishment: an establishment for the production of eggs for hatching intended for the production of utility chicks;
(c) hatchery: an establishment for incubating eggs, hatching and supplying chicks
capacity means the maximum number of eggs for hatching which may be placed simultaneously in incubators excluding hatchers
minced meat any meat that has been minced into fragments or passed through a spiral-screw mincer, and that falls within one of the CN codes referred to in Article 12 of Regulation (EC) No 1760/2000 and contains less than 1 % salt
trimmings small pieces of meat recognised as fit for human consumption produced exclusively during trimming operations during the boning of carcases and/or the cutting up of meat
cut meat meat which has been cut into small cubes, slices or other individual portions that do not require further cutting by an operator before being bought by the final consumer and can be directly used by that consumer. This definition does not cover minced meat and trimmings
pre-packaged cut meat the individual pack offered unaltered to the final consumer or to an establishment engaged solely in retail sales, made up of cut meat and the packaging in which it was packed before being offered for sale, whether the packaging covers it fully or partially, but such that the content cannot be altered without opening or changing the packaging
non-pre-packaged cut meat cut meat displayed for sale non-pre-packaged in outlets for sale to the final consumer and all pieces of meat displayed for sale non-pre-packaged in outlets for sale to the final consumer, intended to be cut at the request of the final consumer
batch meat, on the bone or boned, for example, carcases, quarters or boned pieces of meat, cut up, minced or packed together under practically identical conditions
retail the handling and/or processing of meat and its storage at the point of sale or delivery to the final consumer, including caterers, company canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets
final consumer the ultimate consumer of cut meat who does not use it as part of a food business operation or activity
hybrid vehicle means a vehicle with at least two different energy converters and two different energy storage systems (on vehicle) for the purpose of vehicle propulsion
vehicles designed to fulfil specific social needs means diesel vehicles of category M1 which are either:
(a) special purpose vehicles as defined in Directive 70/156/EEC with a reference mass exceeding 2 000 kg;
(b) vehicles with a reference mass exceeding 2 000 kg and designed to carry seven or more occupants including the driver with the exclusion, as from 1 September 2012, of vehicles of category M1G as defined in Directive 70/156/EEC;
or
(c) vehicles with a reference mass exceeding 1 760 kg which are built specifically for commercial purposes to accommodate wheelchair use inside the vehicle
reference mass means the mass of the vehicle in running order less the uniform mass of the driver of 75 kg and increased by a uniform mass of 100 kg
gaseous pollutants means the exhaust gas emissions of carbon monoxide, oxides of nitrogen, expressed in nitrogen dioxide (NO2) equivalent, and hydrocarbons
particulate pollutants means components of the exhaust gas which are removed from the diluted exhaust gas at a maximum temperature of 325 °K (52 °C) by means of the filters described in the test procedure for verifying average tailpipe emissions
tailpipe emissions means the emission of gaseous and particulate pollutants
evaporative emissions means the hydrocarbon vapours emitted from the fuel system of a vehicle other than those from tailpipe emissions
crankcase means the spaces in, or external to, an engine which are connected to the oil sump by internal or external ducts through which gases and vapours can be emitted
on-board diagnostic system or OBD system means a system for emission control which has the capability of identifying the likely area of malfunction by means of fault codes stored in a computer memory
defeat device means any element of design which senses temperature, vehicle speed, engine speed (RPM), transmission gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any part of the emission control system, that reduces the effectiveness of the emission control system under conditions which may reasonably be expected to be encountered in normal vehicle operation and use
pollution control device means those components of a vehicle that control and/or limit tailpipe and evaporative emissions
original pollution control device means a pollution control device or an assembly of such devices covered by the type approval granted for the vehicle concerned
replacement pollution control device means a pollution control device or an assembly of such devices intended to replace an original pollution control device and which can be approved as a separate technical unit as defined in Directive 70/156/EEC
vehicle repair and maintenance information means all information required for diagnosis, servicing, inspection, periodic monitoring, repair, re-programming or re-initialising of the vehicle and which the manufacturers provide for their authorised dealers and repairers, including all subsequent amendments and supplements to such information. This information includes all information required for fitting parts or equipment on vehicles
independent operator means undertakings other than authorised dealers and repairers which are directly or indirectly involved in the repair and maintenance of motor vehicles, in particular repairers, manufacturers or distributors of repair equipment, tools or spare parts, publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative fuel vehicles
biofuels means liquid or gaseous fuels for transport, produced from biomass
alternative fuel vehicle means a vehicle designed to be capable of running on at least one type of fuel that is either gaseous at atmospheric temperature and pressure, or substantially non-mineral oil derived
direct injection engine means an engine which can operate in a mode where the fuel is injected into the intake air after the air has been drawn through the inlet valves
engine means the motive propulsion source of a vehicle for which type-approval as a separate technical unit, as defined in point 25 of Article 3 of Directive 2007/46/EC, may be granted
gaseous pollutants means the exhaust gas emissions of carbon monoxide, NOx, expressed in NO2 equivalent, and hydrocarbons
particulate pollutants means components of the exhaust gas which are removed from the diluted exhaust gas at a maximum temperature of 325 K (52 °C) by means of the filters described in the test procedure for verifying average tailpipe emissions
tailpipe emissions means the emission of gaseous and particulate pollutants
crankcase means the spaces in, or external to, an engine which are connected to the oil sump by internal or external ducts through which gases and vapours can be emitted
pollution control device means those components of a vehicle that control and/or limit tailpipe emissions
on-board diagnostic (OBD) system means a system on board a vehicle or connected to an engine which has the capability of detecting malfunctions, and, if applicable, of indicating their occurrence by means of an alert system, of identifying the likely area of malfunction by means of information stored in computer memory, and of communicating that information off-board
defeat strategy means an emission control strategy that reduces the effectiveness of the emission controls under ambient or engine operating conditions encountered either during normal vehicle operation or outside the type-approval test procedures
original pollution control device means a pollution control device or an assembly of such devices covered by the type-approval granted for the vehicle concerned
replacement pollution control device means a pollution control device or an assembly of such devices intended to replace an original pollution control device and which can be approved as a separate technical unit, as defined in point 25 of Article 3 of Directive 2007/46/EC
vehicle repair and maintenance information means all information required for diagnosis, servicing, inspection, periodic monitoring, repair, re-programming or re-initialising or the remote diagnostic support of the vehicle and which the manufacturers provide for their authorised dealers and repairers, including all subsequent amendments and supplements to such information. This information includes all information required for fitting parts or equipment onto vehicles
manufacturer means the person or body who is responsible to the approval authority for all aspects of the type-approval or authorisation process and for ensuring conformity of production. It is not essential that the person or body be directly involved in all stages of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process
independent operator means undertakings other than authorised dealers and repairers which are directly or indirectly involved in the repair and maintenance of motor vehicles, in particular repairers, manufacturers or distributors of repair equipment, tools or spare parts, publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative fuel vehicles
alternative fuel vehicle means a vehicle designed to be capable of running on at least one type of fuel that is either gaseous at atmospheric temperature and pressure, or substantially non-mineral oil derived
reference mass means the mass of the vehicle in running order less the uniform mass of the driver of 75 kg and increased by a uniform mass of 100 kg
tampering means inactivation, adjustment or modification of the vehicle emissions control or propulsion system, including any software or other logical control elements of those systems, that has the effect, whether intended or not, of worsening the emissions performance of the vehicle
financial interests of the Union shall include revenues, expenditures and assets covered by the budget of the European Union and those covered by the budgets of the institutions, bodies, offices and agencies and the budgets managed and monitored by them
administrative investigations (investigations) shall mean any inspection, check or other measure undertaken by the Office in accordance with Articles 3 and 4, with a view to achieving the objectives set out in Article 1 and to establishing, where necessary, the irregular nature of the activities under investigation; those investigations shall not affect the powers of the competent authorities of the Member States to initiate criminal proceedings
person concerned shall mean any person or economic operator suspected of having committed fraud, corruption or any other illegal activity affecting the financial interests of the Union and who is therefore subject to investigation by the Office
administrative arrangements shall mean arrangements of a technical and/or operational nature concluded by the Office, which may in particular aim at facilitating the cooperation and the exchange of information between the parties thereto, and which do not create additional legal obligation
vehicle type means a category of motor vehicles which do not differ in essential respects such as:
(a) for vehicles of categories M1, M2 ≤ 3 500 kg, N1 tested in accordance with point 4.1.2.1 of Annex II:
(i) the shape or materials of the bodywork (particularly the engine compartment and its soundproofing);
(ii) the type of engine (e.g. positive or compression ignition, two- or four-stroke, reciprocating or rotary piston), number and capacity of cylinders, number and type of carburettors or injection system, arrangement of valves, or the type of electric motor;
(iii) rated maximum net power and corresponding engine speed(s); however if the rated maximum power and the corresponding engine speed differs only due to different engine mappings, those vehicles may be regarded as of the same type;
(iv) the silencing system;
(b) for vehicles of categories M2 > 3 500 kg, M3, N2, N3 tested in accordance with point 4.1.2.2 of Annex II:
(i) the shape or materials of the bodywork (particularly the engine compartment and its soundproofing);
(ii) the type of engine (e.g. positive or compression ignition, two- or four-stroke, reciprocating or rotary piston), number and capacity of cylinders, type of injection system, arrangement of valves, rated engine speed (S), or the type of electric motor;
(iii) vehicles having the same type of engine and/or different overall gear ratios may be regarded as vehicles of the same type.
However, if the differences in point (b) provide for different target conditions, as described in point 4.1.2.2 of Annex II, those differences shall be regarded as a change of type
technically permissible maximum laden mass (M) means the maximum mass allocated to a vehicle on the basis of its construction features and its design performance; the technically permissible laden mass of a trailer or of a semi-trailer includes the static mass transferred to the towing vehicle when coupled
rated maximum net power (Pn) means the engine power expressed in kW and measured by the UNECE method pursuant to UNECE Regulation No 85.
If the rated maximum net power is reached at several engine speeds, the highest engine speed shall be used
standard equipment means the basic configuration of a vehicle including all features that are fitted without giving rise to any further specifications on configuration or equipment level but equipped with all the features required under the regulatory acts mentioned in Annex IV or Annex XI to Directive 2007/46/EC
mass of the driver means a mass rated at 75 kg located at the driver's seating reference point
mass of a vehicle in running order (mro) means
(a) in the case of a motor vehicle:
the mass of the vehicle, with its fuel tank(s) filled to at least 90 % of its or their capacity/ies, including the mass of the driver, the fuel and liquids, fitted with the standard equipment in accordance with the manufacturer's specifications and, where they are fitted, the mass of the bodywork, the cabin, the coupling and the spare wheel(s) as well as the tools;
(b) in the case of a trailer:
the mass of the vehicle including the fuel and liquids, fitted with the standard equipment in accordance with the manufacturer's specifications, and, when they are fitted, the mass of the bodywork, additional coupling(s), the spare wheel(s) and the tools
rated engine speed (S) means the declared engine speed in min–1 (rpm) at which the engine develops its rated maximum net power pursuant to UNECE Regulation No 85 or, where the rated maximum net power is reached at several engine speeds, the highest one of those speeds
power to mass ratio index (PMR) means a numerical quantity calculated in accordance with the formula set out in point 4.1.2.1.1 of Annex II
reference point means one of the following points:
(a) in the case of vehicles of categories M1 and N1:
(i) for front engine vehicles, the front end of the vehicle;
(ii) for mid engine vehicles, the centre of the vehicle;
(iii) for rear engine vehicles, the rear end of the vehicle.
(b) in the case of vehicles of categories M2, M3, N2 and N3, the border of the engine closest to the front of the vehicle
target acceleration means acceleration at a partial throttle condition in urban traffic as derived from statistical investigations
engine means the power source without detachable accessories
reference acceleration means the required acceleration during the acceleration test on the test track
gear ratio weighting factor (k) means a dimensionless numerical quantity used to combine the test results of two gear ratios for the acceleration test and the constant speed test
partial power factor (kP) means a numerical quantity with no dimension used for the weighted combination of the test results of the acceleration test and the constant speed test for vehicles
pre-acceleration means the application of an acceleration control device prior to AA' for the purpose of achieving stable acceleration between AA' and BB' as referred to in Figure 1 of the Appendix to Annex II
locked gear ratios means the control of transmission such that the transmission gear cannot change during a test
silencing system means a complete set of components necessary for limiting the noise produced by an engine and its exhaust
silencing system of different types means silencing systems which significantly differ in respect of at least one of the following:
(a) trade names or trade marks of their components;
(b) the characteristics of the materials constituting their components, except for the coating of those components;
(c) the shape or size of their components;
(d) the operating principles of at least one of their components;
(e) the assembly of their components;
(f) the number of exhaust silencing systems or components
design family of silencing system or silencing system components means a group of silencing systems, or components thereof, in which all of the following characteristics are the same:
(a) the presence of net gas flow of the exhaust gases through the absorbing fibrous material when in contact with that material;
(b) the type of the fibres;
(c) where applicable, binder material specifications;
(d) average fibre dimensions;
(e) minimum bulk material packing density in kg/m3;
(f) maximum contact surface between the gas flow and the absorbing material
replacement silencing system means any part of the silencing system, or components thereof, intended for use on a vehicle, other than a part of the type fitted to the vehicle when submitted for EU type-approval pursuant to this Regulation
Acoustic Vehicle Alerting System (AVAS) means a system for hybrid electric and pure electric vehicles which provides sound to signal the vehicle's presence to pedestrians and other road users
point of sale means a location where vehicles are stored and offered for sale to consumers
technical promotional material means technical manuals, brochures, leaflets and catalogues, whether they appear in printed, electronic or online form, as well as websites, and the purpose of which is to promote vehicles to the general public
food additive shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods;
The following are not considered to be food additives:
(i) monosaccharides, disaccharides or oligosaccharides and foods containing these substances used for their sweetening properties;
(ii) foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect;
(iii) substances used in covering or coating materials, which do not form part of foods and are not intended to be consumed together with those foods;
(iv) products containing pectin and derived from dried apple pomace or peel of citrus fruits or quinces, or from a mixture of them, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (liquid pectin);
(v) chewing gum bases;
(vi) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes;
(vii) ammonium chloride;
(viii) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten;
(ix) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts having no technological function;
(x) caseinates and casein;
(xi) inulin
undefined shall mean any substance which:
(i) is not consumed as a food by itself;
(ii) is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and
(iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product
functional class shall mean one of the categories set out in Annex I based on the technological function a food additive exerts in the foodstuff
unprocessed food shall mean a food which has not undergone any treatment resulting in a substantial change in the original state of the food, for which purpose the following in particular are not regarded as resulting in substantial change: dividing, parting, severing, boning, mincing, skinning, paring, peeling, grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, husking, packing or unpacking
food with no added sugars shall mean a food without the following:
(i) any added monosaccharides or disaccharides;
(ii) any added food containing monosaccharides or disaccharides which is used for its sweetening properties
energy-reduced food shall mean a food with an energy value reduced by at least 30 % compared with the original food or a similar product
table-top sweeteners shall mean preparations of permitted sweeteners, which may contain other food additives and/or food ingredients and which are intended for sale to the final consumer as a substitute for sugars
quantum satis shall mean that no maximum numerical level is specified and substances shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled
sweeteners are substances used to impart a sweet taste to foods or in table-top sweeteners
colours are substances which add or restore colour in a food, and include natural constituents of foods and natural sources which are normally not consumed as foods as such and not normally used as characteristic ingredients of food. Preparations obtained from foods and other edible natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Regulation
preservatives are substances which prolong the shelf-life of foods by protecting them against deterioration caused by micro-organisms and/or which protect against growth of pathogenic micro-organisms
antioxidants are substances which prolong the shelf-life of foods by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes
carriers are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive or a flavouring, food enzyme, nutrient and/or other substance added for nutritional or physiological purposes to a food without altering its function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use
acids are substances which increase the acidity of a foodstuff and/or impart a sour taste to it
acidity regulators are substances which alter or control the acidity or alkalinity of a foodstuff
anti-caking agents are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another
anti-foaming agents are substances which prevent or reduce foaming
bulking agents are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value
emulsifiers are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff
emulsifying salts are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components
firming agents are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel
flavour enhancers are substances which enhance the existing taste and/or odour of a foodstuff
foaming agents are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff
gelling agents are substances which give a foodstuff texture through formation of a gel
glazing agents (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating
humectants are substances which prevent foods from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium
modified starches are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached
packaging gases are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container
propellants are gases other than air which expel a foodstuff from a container
raising agents are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter
sequestrants are substances which form chemical complexes with metallic ions
stabilisers are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff, substances which stabilise, retain or intensify colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross-links between proteins enabling the binding of food pieces into re-constituted food
thickeners are substances which increase the viscosity of a foodstuff
flour treatment agents are substances, other than emulsifiers, which are added to flour or dough to improve its baking quality
contrast enhancers are substances which, when applied to the external surface of fruit or vegetables following depigmentation of predefined parts (e.g. by laser treatment), help to distinguish these parts from the remaining surface by imparting colour following interaction with certain components of the epidermis
cabin baggage means, in the case of air travel, the baggage that the natural person takes with him into and out of the aircraft cabin
customs office of presentation means the customs office competent for the place where the goods are presented
hold baggage in the case of air travel, means the baggage that has been checked in at the airport of departure and is not accessible to the natural person during the flight nor, where relevant, during any stopovers
identical goods means, in the context of customs valuation, goods produced in the same country which are the same in all respects, including physical characteristics, quality and reputation. Minor differences in appearance shall not preclude goods otherwise conforming to the definition from being regarded as identical
international Union airport means any Union airport which, having been so authorised by the customs authority, is approved for air traffic with territories outside of the customs territory of the Union
intra-Union flight means the movement of an aircraft between two Union airports, without any stopover, which does not start from or end at a non-Union airport
main processed products means the processed products for which the authorisation for inward processing has been granted
marketing activities means, in the context of customs valuation, all activities relating to advertising or marketing and promoting the sale of the goods in question and all activities relating to warranties or guarantees in respect of them
secondary processed products means processed products which are a necessary by-product of the processing operation other than the main processed products
business or tourist aircraft means private aircraft intended for journeys whose itinerary depends on the wishes of the user
public customs warehouse type III means a customs warehouse which is operated by the customs authorities
fixed transport installation means technical means used for continuous transport of goods such as electricity, gas and oil
customs office of transit means either of the following:
(a) the customs office competent for the point of exit from the customs territory of the Union when the goods are leaving that territory in the course of a transit operation via a frontier with a territory outside the customs territory of the Union other than a common transit country;
(b) the customs office competent for the point of entry into the customs territory of the Union when the goods have crossed a territory outside the customs territory of the Union in the course of a transit operation
similar goods in the context of customs valuation, means goods produced in the same country, which, although not alike in all respects, have like characteristics and like component materials which enable them to perform the same functions and to be commercially interchangeable; the quality of the goods, their reputation and the existence of a trademark are among the factors to be considered in determining whether goods are similar
Medicinal product (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis
Substance Any matter irrespective of origin which may be:
— human, e.g.
— human blood and human blood products;
— animal, e.g.
— micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
— vegetable, e.g.
— micro-organisms, plants, parts of plants, vegetable secretions, extracts;
— chemical, e.g.
— elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis
Active substance Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis
Excipient Any constituent of a medicinal product other than the active substance and the packaging material
Immunological medicinal product Any medicinal product consisting of vaccines, toxins, serums or allergen products:
(a) vaccines, toxins and serums shall cover in particular:
(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;
(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;
(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;
(b) ‘allergen product’ shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent
Homeopathic medicinal product Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles
Radiopharmaceutical Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose
Radionuclide generator Any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical
Kit Any preparation to be reconsitituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration
Radionuclide precursor Any other radionuclide produced for the radio-labelling of another substance prior to administration
Medicinal products derived from human blood or human plasma Medicinal products based on blood constitutents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin
Adverse reaction A response to a medicinal product which is noxious and unintended
Serious adverse reaction An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect
Unexpected adverse reaction An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics
Post-authorisation safety study Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures
Abuse of medicinal products Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effets
Wholesale distribution of medicinal products All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned
Brokering of medicinal products All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person
Public service obligation The obligation placed on wholesalers to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question
Representative of the marketing authorisation holder The person, commonly known as local representative, designated by the marketing authorisation holder to represent him in the Member State concerned
Medicinal Prescription Any medicinal prescription issued by a professional person qualified to do so
Name of the medicinal product The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder
Common name The international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name
Strength of the medicinal product The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form
Immediate packaging The container or other form of packaging immediately in contact with the medicinal product
Outer packaging The packaging into which is placed the immediate packaging
Labelling Information on the immediate or outer packaging
Package leaflet A leaflet containing information for the user which accompanies the medicinal product
Agency The European Medicines Agency established by Regulation (EC) No 726/2004
Risks related to use of the medicinal product — any risk relating to the quality, safety or efficacy of the medicinal product as regards patients' health or public health;
— any risk of undesirable effects on the environment
Risk-benefit balance An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in point 28, first indent
Risk management system a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions
Risk management plan a detailed description of the risk management system
Pharmacovigilance system a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance
Pharmacovigilance system master file A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products
Traditional herbal medicinal product A herbal medicinal product that fulfils the conditions laid down in Article 16a(1)
Herbal medicinal product Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations
Herbal substances All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author)
Herbal preparations Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates
Falsified medicinal product Any medicinal product with a false representation of:
(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used.
This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights
Gene therapy medicinal product means a biological medicinal product which has the following characteristics:
(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.
Gene therapy medicinal products shall not include vaccines against infectious diseases
Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
(a) contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
(b) is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.
For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations
motorway means a road, specially designed and built for motor traffic, which does not serve properties bordering on it and which meets the following criteria:
(a) it is provided, except at special points or temporarily, with separate carriageways for the two directions of traffic, separated from each other either by a dividing strip not intended for traffic or, exceptionally, by other means;
(b) it does not cross at level with any road, railway or tramway track, bicycle path or footpath;
(c) it is specifically designated as a motorway;
primary road means a road outside urban areas that connects major cities or regions, or both, belonging to the highest category of road below the category ‘motorway’ in the national road classification that is in place on 26 November 2019
competent entity means any public or private organisation set up at national, regional or local level, involved in the implementation of this Directive by reason of its competences, including bodies designated as competent entities which existed before the entry into force of this Directive, in so far as they meet the requirements of this Directive
road safety impact assessment means a strategic comparative analysis of the impact of a new road or a substantial modification to the existing network on the safety performance of the road network
road safety audit means an independent detailed systematic and technical safety check relating to the design characteristics of a road infrastructure project and covering all stages from planning to early operation
safety rating means the classification of parts of the existing road network in categories according to their objectively measured in-built safety
targeted road safety inspection means a targeted investigation to identify hazardous conditions, defects and problems that increase the risk of accidents and injuries, based on a site visit of an existing road or section of road
periodic road safety inspection means an ordinary periodical verification of the characteristics and defects that require maintenance work for reasons of safety
guidelines means measures adopted by Member States, which lay down the steps to be followed and the elements to be considered in applying the safety procedures set out in this Directive
infrastructure project means a project for the construction of new road infrastructure or a substantial modification to the existing network which affects the traffic flow
vulnerable road user means non-motorised road users, including, in particular, cyclists and pedestrians, as well as users of powered two-wheelers
vehicle shall mean any motor vehicle intended for use on the road, whether complete or incomplete, which has at least four wheels and a maximum design speed exceeding 25 km/h, together with its trailers, with the exception of vehicles which run on rails, of agricultural and forestry tractors and of all mobile machinery
transport shall mean any road transport operation performed by a vehicle wholly or partly on public roads within the territory of a Member State, including the loading and unloading of goods covered by Directive 94/55/EC, without prejudice to the arrangements laid down by the laws of the Member States concerning liability in respect of such operations
undertaking shall mean any natural or legal person, whether or not profit-seeking, any association or group of persons without legal personality, whether or not profit-seeking, and any body coming under a public authority, whether itself possessing legal personality or dependent on an authority having such personality, which carry, load or unload dangerous goods or cause them to be carried and those which temporarily store, collect, package or take delivery of such goods as part of a transport operation and are located in the territory of the Community
check shall mean any check, control, inspection, verification or formality carried out by the competent authorities for reasons of safety inherent in the transport of dangerous goods
registration shall mean the administrative authorisation for the entry into service in road traffic of a vehicle, involving the identification of the latter and the issuing to it of a serial number, to be known as the registration number
registration certificate shall mean the document which certifies that the vehicle is registered in a Member State
holder of the registration certificate shall mean the person in whose name a vehicle is registered
suspension means a limited period of time in which a vehicle is not authorised by a Member State to be used in road traffic following which – provided the reasons for suspension have ceased to apply – it may be authorised to be used again without involving a new process of registration
cancellation of a registration means the cancellation of a Member State’s authorisation for a vehicle to be used in road traffic
ATA Carnet means an international customs document for temporary admission issued in accordance with the ATA Convention or the Istanbul Convention
ATA Convention means the Customs Convention on the ATA carnet for the temporary admission of goods done at Brussels on 6 December 1961
Istanbul Convention means the Convention on temporary admission done at Istanbul on 26 June 1990
baggage means all goods carried by whatever means in relation to a journey of a natural person
Code means Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code
Union airport means any airport situated in the customs territory of the Union
Union port means any sea port situated in the customs territory of the Union
common transit country means any country, other than a Member State of the Union that is a contracting party to the Convention on a common transit procedure
third country means a country or territory outside the customs territory of the Union
CPD Carnet means an international customs document used for temporary admission of means of transport issued in accordance with the Istanbul Convention
customs office of departure means the customs office where the customs declaration placing goods under a transit procedure is accepted
customs office of destination means the customs office where the goods placed under a transit procedure are presented in order to end the procedure
customs office of first entry means the customs office which is competent for customs supervision at the place where the means of transport carrying the goods arrives in the customs territory of the Union from a territory outside that territory
customs office of export means the customs office where the export declaration or the re-export declaration is lodged for goods being taken out of the customs territory of the Union
customs office of placement means customs office indicated in the authorisation for a special procedure as referred to in Article 211(1) of the Code, empowered to release goods for a special procedure
Economic Operators Registration and Identification number (EORI number) means an identification number, unique in the customs territory of the Union, assigned by a customs authority to an economic operator or to another person in order to register him for customs purposes
exporter means:
(a) a private individual carrying goods to be taken out of the customs territory of the Union where these goods are contained in the private individual's personal baggage;
(b) in other cases, where (a) does not apply:
(i) a person established in the customs territory of the Union, who has the power to determine and has determined that the goods are to be taken out of that customs territory;
(ii) where (i) does not apply, any person established in the customs territory of the Union who is a party to the contract under which goods are to be taken out of that customs territory
generally accepted accounting principles means the principles which are recognised or have substantial authoritative support within a country at a particular time as to which economic resources and obligations should be recorded as assets and liabilities, which changes in assets and liabilities should be recorded, how the assets and liabilities and changes in them should be measured, what information should be disclosed and how it should be disclosed, and which financial statements should be prepared
goods of a non-commercial nature means
(a) goods contained in consignments sent by one private individual to another, where such consignments:
(i) are of an occasional nature;
(ii) contain goods exclusively for the personal use of the consignee or his family, which do not by their nature or quantity reflect any commercial interest; and
(iii) are sent to the consignee by the consignor free of payment of any kind;
(b) goods contained in travellers’ personal baggage, where they:
(i) are of an occasional nature; and
(ii) consist exclusively of goods for the personal use of the travellers or their families, or of goods intended as presents; the nature and quantity of such goods must not be such as might indicate that they are being imported or exported for commercial reasons
Master Reference Number (MRN) means the registration number allocated by the competent customs authority to declarations or notifications referred to in Article 5(9) to (14) of the Code, to TIR operations or to proofs of the customs status of Union goods
period for discharge means the time by which goods placed under a special procedure, except transit, or processed products must be placed under a subsequent customs procedure, must be destroyed, must have been taken out of the customs territory of the Union or must be assigned to their prescribed end-use. In case of outward processing the period for discharge means the period within which goods temporarily exported may be re-imported into the customs territory of the Union in the form of processed products and placed under release for free circulation, in order to able to benefit from total or partial relief from import duties
goods in postal consignment means goods other than items of correspondence, contained in a postal parcel or package and conveyed under the responsibility of or by a postal operator in accordance with the provisions of the Universal Postal Union Convention adopted on 10 July 1984 under the aegis of the United Nations Organisation
postal operator means an operator established in and designated by a Member State to provide the international services governed by the Universal Postal Convention
items of correspondence means letters, postcards, braille letters and printed matter not liable to import or export duty
outward processing IM/EX means the prior import of processed products obtained from equivalent goods under outward processing before the export of the goods they are replacing, referred to in Article 223(2)(d) of the Code
outward processing EX/IM means the export of Union goods under outward processing before the import of processed products
inward processing EX/IM means the prior export of processed products obtained from equivalent goods under inward processing before the import of the goods they are replacing, referred to in Article 223(2)(c) of the Code
inward processing IM/EX means the import of non-Union goods under inward processing before the export of processed products
public customs warehouse type I means a public customs warehouse where the responsibilities referred to in Article 242(1) of the Code lie with the holder of the authorisation and with the holder of the procedure
public customs warehouse type II means a public customs warehouse where the responsibilities referred to in Article 242(2) of the Code lie with the holder of the procedure
single transport document means in the context of customs status a transport document issued in a Member State covering the carriage of the goods from the point of departure in the customs territory of the Union to the point of destination in that territory under the responsibility of the carrier issuing the document
special fiscal territory means a part of the customs territory of the Union where the provisions of Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax or Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty and repealing Directive 92/12/EEC do not apply
supervising customs office means
(a) in case of temporary storage as referred to in Title IV of the Code or in case of special procedures other than transit as referred to in Title VII of the Code, the customs office indicated in the authorisation to supervise either the temporary storage of the goods or the special procedure concerned;
(b) in case of simplified customs declaration, as referred to in Article 166 of the Code, centralised clearance, as referred to in Article 179 of the Code, entry in the records, as referred to in Article 182 of the Code the customs office indicated in the authorisation to supervise the placing of the goods under the customs procedure concerned
TIR Convention means the Customs Convention on the International Transport of Goods under cover of TIR carnets done at Geneva on 14 November 1975
TIR operation means the movement of goods within the customs territory of the Union in accordance with the TIR Convention
transhipment means the loading or unloading of products and goods on board a means of transport to another means of transport
traveller means any natural person who:
(a) enters into the customs territory of the Union temporarily and is not normally resident there, or
(b) returns to the customs territory of the Union where he is normally resident, after having been temporarily outside this territory, or
(c) temporarily leaves the customs territory of the Union where he is normally resident, or
(d) leaves the customs territory of the Union after a temporary stay, without being normally resident there
waste and scrap means either of the following:
(a) goods or products which are classified as waste and scrap in accordance with the Combined Nomenclature;
(b) in the context of end-use or inward processing, goods or products resulting from a processing operation, which have no or low economic value and which cannot be used without further processing
pallet means a device on the deck of which a quantity of goods can be assembled to form a unit load for the purpose of transporting it, or of handling or stacking it with the assistance of mechanical appliances. This device is made up of two decks separated by bearers, or of a single deck supported by feet; its overall height is reduced to the minimum compatible with handling by fork lift trucks or pallet trucks; it may or may not have a superstructure
Union factory ship means a vessel which is registered in a part of a Member State's territory forming part of the customs territory of the Union, flies the flag of a Member State and does not catch products of sea-fishing but does process such products on board
Union fishing vessel means a vessel which is registered in a part of a Member State's territory forming part of the customs territory of the Union, flies the flag of a Member State, catches products of sea-fishing and, as the case may be, processes them on boar
regular shipping service means a service which carries goods in vessels that ply only between Union ports and does not come from, go to or call at any points outside the customs territory of the Union or any points in a free zone of a Union port
manufacture means any kind of working or processing including assembly
material means any ingredient, raw material, component or part, etc., used in the manufacture of the product
product means the product being manufactured, even if it is intended for later use in another manufacturing operation
goods means both materials and products
bilateral cumulation means a system that allows products which originate in the Union, to be considered as materials originating in a beneficiary country when they are further processed or incorporated into a product in that beneficiary country
cumulation with Norway, Switzerland or Turkey means a system that allows products which originate in Norway, Switzerland or Turkey to be considered as originating materials in a beneficiary country when they are further processed or incorporated into a product in that beneficiary country and imported into the Union
regional cumulation means a system whereby products which according to this Regulation originate in a country which is a member of a regional group are considered as materials originating in another country of the same regional group (or a country of another regional group where cumulation between groups is possible) when further processed or incorporated in a product manufactured there
extended cumulation means a system, conditional upon the granting by the Commission, on a request lodged by a beneficiary country and whereby certain materials, originating in a country with which the Union has a free-trade agreement in accordance with Article XXIV of the General Agreement on Tariffs and Trade (GATT) in force, are considered to be materials originating in the beneficiary country concerned when further processed or incorporated in a product manufactured in that country
fungible materials means materials that are of the same kind and commercial quality, with the same technical and physical characteristics, and which cannot be distinguished from one another once they are incorporated into the finished product
regional group means a group of countries between which regional cumulation applies
customs value means the value as determined in accordance with the 1994 Agreement on Implementation of Article VII of the General Agreement on Tariffs and Trade (WTO Agreement on Customs Valuation)
value of materials means the customs value at the time of importation of the non-originating materials used, or, if this is not known and cannot be ascertained, the first ascertainable price paid for the materials in the country of production; where the value of the originating materials used needs to be established, this point should be applied mutatis mutandis
ex-works price means the price paid for the product ex-works to the manufacturer in whose undertaking the last working or processing is carried out, provided that the price includes the value of all the materials used and all other costs related to its production, minus any internal taxes which are, or may be, repaid when the product obtained is exported.
Where the actual price paid does not reflect all costs related to the manufacturing of the product which are actually incurred in the country of production, the ex-works price means the sum of all those costs, minus any internal taxes which are, or may be, repaid when the product obtained is exported;
Where the last working or processing has been subcontracted to a manufacturer, the term ‘manufacturer’ referred to in the first sub-paragraph may refer to the enterprise that has employed the subcontractor
maximum content of non-originating materials means the maximum content of non-originating materials which is permitted in order to consider a manufacture as working or processing sufficient to confer originating status on the product. It may be expressed as a percentage of the ex-works price of the product or as a percentage of the net weight of these materials used falling under a specified group of chapters, chapter, heading or sub-heading
net weight means the weight of the goods themselves without packing materials and packing containers of any kind
chapters, headings and sub-headings mean the chapters, the headings and sub-headings (four- or six-digit codes) used in the nomenclature which makes up the Harmonized System with the changes pursuant to the recommendation of 26 June 2004 of the Customs Cooperation Council
classified refers to the classification of a product or material under a particular heading or sub-heading of the Harmonized System
consignment means products which are either:
(a) sent simultaneously from one exporter to one consignee; or
(b) covered by a single transport document covering their shipment from the exporter to the consignee or, in the absence of such document, by a single invoice
exporter means a person exporting the goods to the Union or to a beneficiary country who is able to prove the origin of the goods, whether or not he is the manufacturer and whether or not he himself carries out the export formalities
registered exporter means:
(a) an exporter who is established in a beneficiary country and is registered with the competent authorities of that beneficiary country for the purpose of exporting products under the scheme, be it to the Union or another beneficiary country with which regional cumulation is possible; or
(b) an exporter who is established in a Member State and is registered with the customs authorities of that Member State for the purpose of exporting products originating in the Union to a country or territory with which the Union has a preferential trade arrangement; or
(c) a re-consignor of goods who is established in a Member State and is registered with the customs authorities of that Member State for the purpose of making out replacement statements on origin in order to re-consign originating products elsewhere within the customs territory of the Union or, where applicable, to Norway or Switzerland (‘a registered re-consignor’)
statement on origin means a statement made out by the exporter or the re-consignor of the goods indicating that the products covered by it comply with the rules of origin of the scheme
property means assets of any kind, whether corporeal or incorporeal, movable or immovable, tangible or intangible, and legal documents or instruments in any form including electronic or digital, evidencing title to or an interest in such assets
criminal activity means any kind of criminal involvement in the commission of the following serious crimes:
(a) terrorist offences, offences related to a terrorist group and offences related to terrorist activities as set out in Titles II and III of Directive (EU) 2017/541;
(b) any of the offences referred in Article 3(1)(a) of the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances;
(c) the activities of criminal organisations as defined in Article 1(1) of Council Framework Decision 2008/841/JHA ;
(d) fraud affecting the Union's financial interests, where it is at least serious, as defined in Article 1(1) and Article 2(1) of the Convention on the protection of the European Communities' financial interests;
(e) corruption;
(f) all offences, including tax crimes relating to direct taxes and indirect taxes and as defined in the national law of the Member States, which are punishable by deprivation of liberty or a detention order for a maximum of more than one year or, as regards Member States that have a minimum threshold for offences in their legal system, all offences punishable by deprivation of liberty or a detention order for a minimum of more than six months
financial institution means:
(a) an undertaking other than a credit institution, which carries out one or more of the activities listed in points (2) to (12), (14) and (15) of Annex I to Directive 2013/36/EU of the European Parliament and of the Council, including the activities of currency exchange offices (bureaux de change);
(b) an insurance undertaking as defined in point (1) of Article 13 of Directive 2009/138/EC of the European Parliament and of the Council, insofar as it carries out life assurance activities covered by that Directive;
(c) an investment firm as defined in point (1) of Article 4(1) of Directive 2004/39/EC of the European Parliament and of the Council;
(d) a collective investment undertaking marketing its units or shares;
(e) an insurance intermediary as defined in point (5) of Article 2 of Directive 2002/92/EC of the European Parliament and of the Council where it acts with respect to life insurance and other investment-related services, with the exception of a tied insurance intermediary as defined in point (7) of that Article;
(f) branches, when located in the Union, of financial institutions as referred to in points (a) to (e), whether their head office is situated in a Member State or in a third country
self-regulatory body means a body that represents members of a profession and has a role in regulating them, in performing certain supervisory or monitoring type functions and in ensuring the enforcement of the rules relating to them
beneficial owner means any natural person(s) who ultimately owns or controls the customer and/or the natural person(s) on whose behalf a transaction or activity is being conducted and includes at least:
(a) in the case of corporate entities:
(i) the natural person(s) who ultimately owns or controls a legal entity through direct or indirect ownership of a sufficient percentage of the shares or voting rights or ownership interest in that entity, including through bearer shareholdings, or through control via other means, other than a company listed on a regulated market that is subject to disclosure requirements consistent with Union law or subject to equivalent international standards which ensure adequate transparency of ownership information.
A shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a natural person shall be an indication of direct ownership. A shareholding of 25 % plus one share or an ownership interest of more than 25 % in the customer held by a corporate entity, which is under the control of a natural person(s), or by multiple corporate entities, which are under the control of the same natural person(s), shall be an indication of indirect ownership. This applies without prejudice to the right of Member States to decide that a lower percentage may be an indication of ownership or control. Control through other means may be determined, inter alia, in accordance with the criteria in Article 22(1) to (5) of Directive 2013/34/EU of the European Parliament and of the Council;
(ii) if, after having exhausted all possible means and provided there are no grounds for suspicion, no person under point (i) is identified, or if there is any doubt that the person(s) identified are the beneficial owner(s), the natural person(s) who hold the position of senior managing official(s), the obliged entities shall keep records of the actions taken in order to identify the beneficial ownership under point (i) and this point;
(b) in the case of trusts, all following persons:
(i) the settlor(s);
(ii) the trustee(s);
(iii) the protector(s), if any;
(iv) the beneficiaries or where the individuals benefiting from the legal arrangement or entity have yet to be determined, the class of persons in whose main interest the legal arrangement or entity is set up or operates;
(v) any other natural person exercising ultimate control over the trust by means of direct or indirect ownership or by other means;
(c) in the case of legal entities such as foundations, and legal arrangements similar to trusts, the natural person(s) holding equivalent or similar positions to those referred to in point (b)
trust or company service provider means any person that, by way of its business, provides any of the following services to third parties:
(a) the formation of companies or other legal persons;
(b) acting as, or arranging for another person to act as, a director or secretary of a company, a partner of a partnership, or a similar position in relation to other legal persons;
(c) providing a registered office, business address, correspondence or administrative address and other related services for a company, a partnership or any other legal person or arrangement;
(d) acting as, or arranging for another person to act as, a trustee of an express trust or a similar legal arrangement;
(e) acting as, or arranging for another person to act as, a nominee shareholder for another person other than a company listed on a regulated market that is subject to disclosure requirements in accordance with Union law or subject to equivalent international standards
correspondent relationship means:
(a) the provision of banking services by one bank as the correspondent to another bank as the respondent, including providing a current or other liability account and related services, such as cash management, international funds transfers, cheque clearing, payable-through accounts and foreign exchange services;
(b) the relationships between and among credit institutions and financial institutions including where similar services are provided by a correspondent institution to a respondent institution, and including relationships established for securities transactions or funds transfers
politically exposed person means a natural person who is or who has been entrusted with prominent public functions and includes the following:
(a) heads of State, heads of government, ministers and deputy or assistant ministers;
(b) members of parliament or of similar legislative bodies;
(c) members of the governing bodies of political parties;
(d) members of supreme courts, of constitutional courts or of other high-level judicial bodies, the decisions of which are not subject to further appeal, except in exceptional circumstances;
(e) members of courts of auditors or of the boards of central banks;
(f) ambassadors, chargés d'affaires and high-ranking officers in the armed forces;
(g) members of the administrative, management or supervisory bodies of State-owned enterprises;
(h) directors, deputy directors and members of the board or equivalent function of an international organisation.
No public function referred to in points (a) to (h) shall be understood as covering middle-ranking or more junior officials
family members includes the following:
(a) the spouse, or a person considered to be equivalent to a spouse, of a politically exposed person;
(b) the children and their spouses, or persons considered to be equivalent to a spouse, of a politically exposed person;
(c) the parents of a politically exposed person
persons known to be close associates means:
(a) natural persons who are known to have joint beneficial ownership of legal entities or legal arrangements, or any other close business relations, with a politically exposed person;
(b) natural persons who have sole beneficial ownership of a legal entity or legal arrangement which is known to have been set up for the de facto benefit of a politically exposed person
senior management means an officer or employee with sufficient knowledge of the institution's money laundering and terrorist financing risk exposure and sufficient seniority to take decisions affecting its risk exposure, and need not, in all cases, be a member of the board of directors
business relationship means a business, professional or commercial relationship which is connected with the professional activities of an obliged entity and which is expected, at the time when the contact is established, to have an element of duration
gambling services means a service which involves wagering a stake with monetary value in games of chance, including those with an element of skill such as lotteries, casino games, poker games and betting transactions that are provided at a physical location, or by any means at a distance, by electronic means or any other technology for facilitating communication, and at the individual request of a recipient of services
group means a group of undertakings which consists of a parent undertaking, its subsidiaries, and the entities in which the parent undertaking or its subsidiaries hold a participation, as well as undertakings linked to each other by a relationship within the meaning of Article 22 of Directive 2013/34/EU
shell bank means a credit institution or financial institution, or an institution that carries out activities equivalent to those carried out by credit institutions and financial institutions, incorporated in a jurisdiction in which it has no physical presence, involving meaningful mind and management, and which is unaffiliated with a regulated financial group
virtual currencies means a digital representation of value that is not issued or guaranteed by a central bank or a public authority, is not necessarily attached to a legally established currency and does not possess a legal status of currency or money, but is accepted by natural or legal persons as a means of exchange and which can be transferred, stored and traded electronically
custodian wallet provider means an entity that provides services to safeguard private cryptographic keys on behalf of its customers, to hold, store and transfer virtual currencies
terrorist financing means the provision or collection of funds, by any means, directly or indirectly, with the intention that they be used or in the knowledge that they are to be used, in full or in part, in order to carry out any of the offences within the meaning of Articles 1 to 4 of Council Framework Decision 2002/475/JHA
proceeds means any economic advantage derived directly or indirectly from a criminal offence; it may consist of any form of property and includes any subsequent reinvestment or transformation of direct proceeds and any valuable benefits
property means property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents or instruments evidencing title or interest in such property
instrumentalities means any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences
confiscation means a final deprivation of property ordered by a court in relation to a criminal offence
freezing means the temporary prohibition of the transfer, destruction, conversion, disposal or movement of property or temporarily assuming custody or control of property
deposit means a credit balance which results from funds left in an account or from temporary situations deriving from normal banking transactions and which a credit institution is required to repay under the legal and contractual conditions applicable, including a fixed-term deposit and a savings deposit, but excluding a credit balance where:
(a) its existence can only be proven by a financial instrument as defined in Article 4(17) of Directive 2004/39/EC of the European Parliament and of the Council ( 14 ), unless it is a savings product which is evidenced by a certificate of deposit made out to a named person and which exists in a Member State on 2 July 2014;
(b) its principal is not repayable at par;
(c) its principal is only repayable at par under a particular guarantee or agreement provided by the credit institution or a third party
depositor means the holder or, in the case of a joint account, each of the holders, of a deposit
joint account means an account opened in the name of two or more persons or over which two or more persons have rights that are exercised by means of the signature of one or more of those persons
unavailable deposit means a deposit that is due and payable but that has not been paid by a credit institution under the legal or contractual conditions applicable thereto, where either:
(a) the relevant administrative authorities have determined that in their view the credit institution concerned appears to be unable for the time being, for reasons which are directly related to its financial circumstances, to repay the deposit and the institution has no current prospect of being able to do so; or
(b) a judicial authority has made a ruling for reasons which are directly related to the credit institution’s financial circumstances and which has the effect of suspending the rights of depositors to make claims against it
branch means a place of business in a Member State which forms a legally dependent part of a credit institution and which carries out directly all or some of the transactions inherent in the business of credit institutions
target level means the amount of available financial means which the DGS is required to reach in accordance with Article 10(2), expressed as a percentage of covered deposits of its members
available financial means means cash, deposits and low-risk assets which can be liquidated within a period not exceeding that referred to in Article 8(1) and payment commitments up to the limit set out in Article 10(3)
payment commitments means payment commitments of a credit institution towards a DGS which are fully collateralised providing that the collateral:
(a) consists of low risk assets;
(b) is unencumbered by any third-party rights and is at the disposal of the DGS
designated authority means a body which administers a DGS pursuant to this Directive, or, where the operation of the DGS is administered by a private entity, a public authority designated by the Member State concerned for supervising that scheme pursuant to this Directive
waste means any substance or object which the holder discards or intends or is required to discard
hazardous waste means waste which displays one or more of the hazardous properties listed in Annex III
municipal waste means:
(a) mixed waste and separately collected waste from households, including paper and cardboard, glass, metals, plastics, bio-waste, wood, textiles, packaging, waste electrical and electronic equipment, waste batteries and accumulators, and bulky waste, including mattresses and furniture;
(b) mixed waste and separately collected waste from other sources, where such waste is similar in nature and composition to waste from households;
Municipal waste does not include waste from production, agriculture, forestry, fishing, septic tanks and sewage network and treatment, including sewage sludge, end-of-life vehicles or construction and demolition waste.
This definition is without prejudice to the allocation of responsibilities for waste management between public and private actors
construction and demolition waste means waste generated by construction and demolition activities
waste oils means any mineral or synthetic lubrication or industrial oils which have become unfit for the use for which they were originally intended, such as used combustion engine oils and gearbox oils, lubricating oils, oils for turbines and hydraulic oils
bio-waste means biodegradable garden and park waste, food and kitchen waste from households, offices, restaurants, wholesale, canteens, caterers and retail premises and comparable waste from food processing plants
waste producer means anyone whose activities produce waste (original waste producer) or anyone who carries out pre-processing, mixing or other operations resulting in a change in the nature or composition of this waste
waste holder means the waste producer or the natural or legal person who is in possession of the waste
dealer means any undertaking which acts in the role of principal to purchase and subsequently sell waste, including such dealers who do not take physical possession of the waste
broker means any undertaking arranging the recovery or disposal of waste on behalf of others, including such brokers who do not take physical possession of the waste
waste management means the collection, transport, recovery (including sorting), and disposal of waste, including the supervision of such operations and the after-care of disposal sites, and including actions taken as a dealer or broker
collection means the gathering of waste, including the preliminary sorting and preliminary storage of waste for the purposes of transport to a waste treatment facility
separate collection means the collection where a waste stream is kept separately by type and nature so as to facilitate a specific treatment
prevention means measures taken before a substance, material or product has become waste, that reduce:
(a) the quantity of waste, including through the re-use of products or the extension of the life span of products;
(b) the adverse impacts of the generated waste on the environment and human health; or
(c) the content of hazardous substances in materials and products
re-use means any operation by which products or components that are not waste are used again for the same purpose for which they were conceived
treatment means recovery or disposal operations, including preparation prior to recovery or disposal
recovery means any operation the principal result of which is waste serving a useful purpose by replacing other materials which would otherwise have been used to fulfil a particular function, or waste being prepared to fulfil that function, in the plant or in the wider economy. Annex II sets out a non-exhaustive list of recovery operations
material recovery means any recovery operation, other than energy recovery and the reprocessing into materials that are to be used as fuels or other means to generate energy. It includes, inter alia, preparing for re-use, recycling and backfilling
preparing for re-use means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing
recycling means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations
backfilling means any recovery operation where suitable non-hazardous waste is used for purposes of reclamation in excavated areas or for engineering purposes in landscaping. Waste used for backfilling must substitute non-waste materials, be suitable for the aforementioned purposes, and be limited to the amount strictly necessary to achieve those purposes
regeneration of waste oils means any recycling operation whereby base oils can be produced by refining waste oils, in particular by removing the contaminants, the oxidation products and the additives contained in such oils
disposal means any operation which is not recovery even where the operation has as a secondary consequence the reclamation of substances or energy. Annex I sets out a non-exhaustive list of disposal operations
extended producer responsibility scheme means a set of measures taken by Member States to ensure that producers of products bear financial responsibility or financial and organisational responsibility for the management of the waste stage of a product’s life cycle
resolution means the application of a resolution tool or a tool referred to in Article 37(9) in order to achieve one or more of the resolution objectives referred to in Article 31(2)
competent ministries means finance ministries or other ministries of the Member States which are responsible for economic, financial and budgetary decisions at the national level according to national competencies and which have been designated in accordance with Article 3(5)
institution means a credit institution or an investment firm
group means a parent undertaking and its subsidiaries
cross-border group means a group having group entities established in more than one Member State
extraordinary public financial support means State aid within the meaning of Article 107(1) TFEU, or any other public financial support at supra-national level, which, if provided for at national level, would constitute State aid, that is provided in order to preserve or restore the viability, liquidity or solvency of an institution or entity referred to in point (b), (c) or (d) of Article 1(1) or of a group of which such an institution or entity forms part
emergency liquidity assistance means the provision by a central bank of central bank money, or any other assistance that may lead to an increase in central bank money, to a solvent financial institution, or group of solvent financial institutions, that is facing temporary liquidity problems, without such an operation being part of monetary policy
systemic crisis means a disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructure may be potentially systemically important to some degree
group entity means a legal person that is part of a group
recovery plan means a recovery plan drawn up and maintained by an institution in accordance with Article 5
group recovery plan means a group recovery plan drawn up and maintained in accordance with Article 7
critical functions means activities, services or operations the discontinuance of which is likely in one or more Member States, to lead to the disruption of services that are essential to the real economy or to disrupt financial stability due to the size, market share, external and internal interconnectedness, complexity or cross-border activities of an institution or group, with particular regard to the substitutability of those activities, services or operations
core business lines means business lines and associated services which represent material sources of revenue, profit or franchise value for an institution or for a group of which an institution forms part
resolution action means the decision to place an institution or entity referred to in point (b), (c) or (d) of Article 1(1) under resolution pursuant to Article 32 or 33, the application of a resolution tool, or the exercise of one or more resolution powers
group resolution means either of the following:
(a) the taking of resolution action at the level of a parent undertaking or of an institution subject to consolidated supervision, or
(b) the coordination of the application of resolution tools and the exercise of resolution powers by resolution authorities in relation to group entities that meet the conditions for resolution
group-level resolution authority means the resolution authority in the Member State in which the consolidating supervisor is situated
normal insolvency proceedings means collective insolvency proceedings which entail the partial or total divestment of a debtor and the appointment of a liquidator or an administrator normally applicable to institutions under national law and either specific to those institutions or generally applicable to any natural or legal person
debt instruments (i) for the purpose of points (g) and (j) of Article 63(1), means bonds and other forms of transferrable debt, instruments creating or acknowledging a debt, and instruments giving rights to acquire debt instruments; and
(ii) for the purpose of Article 108, means bonds and other forms of transferrable debt and instruments creating or acknowledging a debt
Union State aid framework means the framework established by Articles 107, 108 and 109 TFEU and regulations and all Union acts, including guidelines, communications and notices, made or adopted pursuant to Article 108(4) or Article 109 TFEU
asset separation tool means the mechanism for effecting a transfer by a resolution authority of assets, rights or liabilities of an institution under resolution to an asset management vehicle in accordance with Article 42
asset management vehicle means a legal person that meets the requirements laid down in Article 42(2)
bail-in tool means the mechanism for effecting the exercise by a resolution authority of the write-down and conversion powers in relation to liabilities of an institution under resolution in accordance with Article 43
sale of business tool means the mechanism for effecting a transfer by a resolution authority of shares or other instruments of ownership issued by an institution under resolution, or assets, rights or liabilities, of an institution under resolution to a purchaser that is not a bridge institution, in accordance with Article 38
bridge institution means a legal person that meets the requirements laid down in Article 40(2)
bridge institution tool means the mechanism for transferring shares or other instruments of ownership issued by an institution under resolution or assets, rights or liabilities of an institution under resolution to a bridge institution, in accordance with Article 40
instruments of ownership means shares, other instruments that confer ownership, instruments that are convertible into or give the right to acquire shares or other instruments of ownership, and instruments representing interests in shares or other instruments of ownership
shareholders means shareholders or holders of other instruments of ownership
transfer powers means the powers specified in point (c) or (d) of Article 63(1) to transfer shares, other instruments of ownership, debt instruments, assets, rights or liabilities, or any combination of those items from an institution under resolution to a recipient
write-down and conversion powers means the powers referred to in Article 59(2) and in points (e) to (i) of Article 63(1)
secured liability means a liability where the right of the creditor to payment or other form of performance is secured by a charge, pledge or lien, or collateral arrangements including liabilities arising from repurchase transactions and other title transfer collateral arrangements
aggregate amount means the aggregate amount by which the resolution authority has assessed that bail-inable liabilities are to be written down or converted, in accordance with Article 46(1)
bail-inable liabilities means the liabilities and capital instruments that do not qualify as Common Equity Tier 1, Additional Tier 1 or Tier 2 instruments of an institution or entity referred to in point (b), (c) or (d) of Article 1(1) and that are not excluded from the scope of the bail-in tool pursuant to Article 44(2)
relevant capital instruments for the purposes of Section 5 of Chapter IV of Title IV and Chapter V of Title IV, means Additional Tier 1 instruments and Tier 2 instruments
conversion rate means the factor that determines the number of shares or other instruments of ownership into which a liability of a specific class will be converted, by reference either to a single instrument of the class in question or to a specified unit of value of a debt claim
affected creditor means a creditor whose claim relates to a liability that is reduced or converted to shares or other instruments of ownership by the exercise of the write down or conversion power pursuant to the use of the bail-in tool
affected holder means a holder of instruments of ownership whose instruments of ownership are cancelled by means of the power referred to in point (h) of Article 63(1)
relevant parent institution means a parent institution in a Member State, a Union parent institution, a financial holding company, a mixed financial holding company, a mixed-activity holding company, a parent financial holding company in a Member State, a Union parent financial holding company, a parent mixed financial holding company in a Member State, or a Union parent mixed financial holding company, in relation to which the bail-in tool is applied
recipient means the entity to which shares, other instruments of ownership, debt instruments, assets, rights or liabilities, or any combination of those items are transferred from an institution under resolution
business day means a day other than a Saturday, a Sunday or a public holiday in the Member State concerned
termination right means a right to terminate a contract, a right to accelerate, close out, set-off or net obligations or any similar provision that suspends, modifies or extinguishes an obligation of a party to the contract or a provision that prevents an obligation under the contract from arising that would otherwise arise
institution under resolution means an institution, a financial institution, a financial holding company, a mixed financial holding company, a mixed-activity holding company, a parent financial holding company in a Member State, a Union parent financial holding company, a parent mixed financial holding company in a Member State, or a Union parent mixed financial holding company, in respect of which a resolution action is take
resolution entity means:
(a) a legal person established in the Union, which, in accordance with Article 12, is identified by the resolution authority as an entity in respect of which the resolution plan provides for resolution action; or
(b) an institution that is not part of a group that is subject to consolidated supervision pursuant to Articles 111 and 112 of Directive 2013/36/EU, in respect of which the resolution plan drawn up pursuant to Article 10 of this Directive provides for resolution action
resolution group means:
(a) a resolution entity and its subsidiaries that are not:
(i) resolution entities themselves;
(ii) subsidiaries of other resolution entities; or
(iii) entities established in a third country that are not included in the resolution group in accordance with the resolution plan and their subsidiaries; or
(b) credit institutions permanently affiliated to a central body and the central body itself when at least one of those credit institutions or the central body is a resolution entity, and their respective subsidiaries
Union subsidiary means an institution which is established in a Member State and which is a subsidiary of a third-country institution or a third-country parent undertaking
Union parent undertaking means a Union parent institution, a Union parent financial holding company or a Union parent mixed financial holding company
third-country institution means an entity, the head office of which is established in a third country, that would, if it were established within the Union, be covered by the definition of an institution
third-country parent undertaking means a parent undertaking, a parent financial holding company or a parent mixed financial holding company, established in a third country
third-country resolution proceedings means an action under the law of a third country to manage the failure of a third-country institution or a third-country parent undertaking that is comparable, in terms of objectives and anticipated results, to resolution actions under this Directive
Union branch means a branch located in a Member State of a third-country institution
relevant third-country authority means a third-country authority responsible for carrying out functions comparable to those of resolution authorities or competent authorities pursuant to this Directive
group financing arrangement means the financing arrangement or arrangements of the Member State of the group-level resolution authority
back-to-back transaction means a transaction entered into between two group entities for the purpose of transferring, in whole or in part, the risk generated by another transaction entered into between one of those group entities and a third party
intra-group guarantee means a contract by which one group entity guarantees the obligations of another group entity to a third party
netting arrangement means an arrangement under which a number of claims or obligations can be converted into a single net claim, including close-out netting arrangements under which, on the occurrence of an enforcement event (however or wherever defined) the obligations of the parties are accelerated so as to become immediately due or are terminated, and in either case are converted into or replaced by a single net claim, including ‘close-out netting provisions’ as defined in point (n)(i) of Article 2(1) of Directive 2002/47/EC and ‘netting’ as defined in point (k) of Article 2 of Directive 98/26/EC
set-off arrangement means an arrangement under which two or more claims or obligations owed between the institution under resolution and a counterparty can be set off against each other
financial contracts includes the following contracts and agreements:
(a) securities contracts, including:
(i) contracts for the purchase, sale or loan of a security, a group or index of securities;
(ii) options on a security or group or index of securities;
(iii) repurchase or reverse repurchase transactions on any such security, group or index;
(b) commodities contracts, including:
(i) contracts for the purchase, sale or loan of a commodity or group or index of commodities for future delivery;
(ii) options on a commodity or group or index of commodities;
(iii) repurchase or reverse repurchase transactions on any such commodity, group or index;
(c) futures and forwards contracts, including contracts (other than a commodities contract) for the purchase, sale or transfer of a commodity or property of any other description, service, right or interest for a specified price at a future date;
(d) swap agreements, including:
(i) swaps and options relating to interest rates; spot or other foreign exchange agreements; currency; an equity index or equity; a debt index or debt; commodity indexes or commodities; weather; emissions or inflation;
(ii) total return, credit spread or credit swaps;
(iii) any agreements or transactions that are similar to an agreement referred to in point (i) or (ii) which is the subject of recurrent dealing in the swaps or derivatives markets;
(e) inter-bank borrowing agreements where the term of the borrowing is three months or less;
(f) master agreements for any of the contracts or agreements referred to in points (a) to (e)
crisis prevention measure means the exercise of powers to direct removal of deficiencies or impediments to recoverability under Article 6(6), the exercise of powers to address or remove impediments to resolvability under Article 17 or 18, the application of an early intervention measure under Article 27, the appointment of a temporary administrator under Article 29 or the exercise of the write down or conversion powers under Article 59
recovery capacity means the capability of an institution to restore its financial position following a significant deterioration
issuing State shall mean the Member State in which a judicial authority, as defined in the national law of the issuing State, has made, validated or in any way confirmed a freezing order in the framework of criminal proceedings
executing State shall mean the Member State in whose territory the property or evidence is located
freezing order shall mean any measure taken by a competent judicial authority in the issuing State in order provisionally to prevent the destruction, transformation, moving, transfer or disposal of property that could be subject to confiscation or evidence
property includes property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents and instruments evidencing title to or interest in such property, which the competent judicial authority in the issuing State considers:
— is the proceeds of an offence referred to in Article 3, or equivalent to either the full value or part of the value of such proceeds, or
— constitutes the instrumentalities or the objects of such an offence
evidence shall mean objects, documents or data which could be produced as evidence in criminal proceedings concerning an offence referred to in Article 3
issuing State shall mean the Member State in which a court has issued a confiscation order within the framework of criminal proceedings
executing State shall mean the Member State to which a confiscation order has been transmitted for the purpose of execution
confiscation order shall mean a final penalty or measure imposed by a court following proceedings in relation to a criminal offence or offences, resulting in the definitive deprivation of property
property shall mean property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents and instruments evidencing title to or interest in such property, which the court in the issuing State has decided:
(i) is the proceeds of an offence, or equivalent to either the full value or part of the value of such proceeds,
or
(ii) constitutes the instrumentalities of such an offence,
or
(iii) is liable to confiscation resulting from the application in the issuing State of any of the extended powers of confiscation specified in Article 3(1) and (2) of Framework Decision 2005/212/JHA,
or
(iv) is liable to confiscation under any other provisions relating to extended powers of confiscation under the law of the issuing State
proceeds shall mean any economic advantage derived from criminal offences. It may consist of any form of property
instrumentalities shall mean any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences
residues means one or more substances present in or on plants or plant products, edible animal products, drinking water or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products
substances means chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process
preparations means mixtures or solutions composed of two or more substances intended for use as a plant protection product or as an adjuvant
substance of concern means any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a plant protection product in sufficient concentration to present risks of such an effect
plants means live plants and live parts of plants, including fresh fruit, vegetables and seeds
plant products means products of plant origin in an unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, but excluding plants
harmful organisms means any species, strain or biotype belonging to the animal kingdom or plant kingdom or pathogenic agent injurious to plants or plant products
non-chemical methods means alternative methods to chemical pesticides for plant protection and pest management, based on agronomic techniques such as those referred to in point 1 of Annex III to Directive 2009/128/EC, or physical, mechanical or biological pest control methods
placing on the market means the holding for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves, but not the return to the previous seller. Release for free circulation into the territory of the Community shall constitute placing on the market for the purposes of this Regulation
authorisation of a plant protection product means an administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory
producer means a person who manufactures plant protection products, active substances, safeners, synergists, co-formulants or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation
letter of access means an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant
environment means waters (including ground, surface, transitional, coastal and marine), sediment, soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms
vulnerable groups means persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, the unborn, infants and children, the elderly and workers and residents subject to high pesticide exposure over the long term
micro-organisms means any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material
good plant protection practice means a practice whereby the treatments with plant protection products applied to given plants or plant products, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure acceptable efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control
data protection means the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant
rapporteur Member State means the Member State which undertakes the task of evaluating an active substance, safener or synergist
tests and studies means investigations or experiments whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products
authorisation holder means any natural or legal person holding an authorisation of a plant protection product
minor use means use of a plant protection product in a particular Member State on plants or plant products which are:
(a) not widely grown in that Member State; or
(b) widely grown, to meet an exceptional plant protection need
greenhouse means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment.
For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses
post-harvest treatment means treatment of plants or plant products after harvest in an isolated space where no run-off is possible, for example in a warehouse
biodiversity means variability among living organisms from all sources, including terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this variability may include diversity within species, between species and of ecosystems
competent authority means any authority or authorities of a Member State responsible for carrying out the tasks established under this Regulation
advertisement means a means of promoting the sale or use of plant protection products (to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents) by printed or electronic media
metabolite means any metabolite or a degradation product of an active substance, safener or synergist, formed either in organisms or in the environment.
A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures
impurity means any component other than the pure active substance and/or variant which is present in the technical material (including components originating from the manufacturing process or from degradation during storage)
plant biostimulant means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
(a) nutrient use efficiency;
(b) tolerance to abiotic stress;
(c) quality traits;
(d) availability of confined nutrients in soil or rhizosphere
Union strategy for smart, sustainable and inclusive growth means the targets and shared objectives guiding the action of Member States and the Union set out in the Conclusions adopted by the European Council of 17 June 2010 as Annex I (New European Strategy for Jobs and Growth, EU Headline Targets), Council Recommendation of 13 July 2010 and in Council Decision 2010/707/EU, and any revision of such targets and shared objectives
a strategic policy framework means a document or a set of documents established at national or regional level, which sets out a limited number of coherent priorities established on the basis of evidence and a timeframe for the implementation of those priorities and which may include a monitoring mechanism
smart specialisation strategy means the national or regional innovation strategies which set priorities in order to build competitive advantage by developing and matching research and innovation own strengths to business needs in order to address emerging opportunities and market developments in a coherent manner, while avoiding duplication and fragmentation of efforts; a smart specialisation strategy may take the form of, or be included in, a national or regional research and innovation (R&I) strategic policy framework
Fund-specific rules means the provisions laid down in, or established on the basis of, Part Three or Part Four of this Regulation or a Regulation governing one or more of the ESI Funds listed in the fourth paragraph of Article 1
programming means the process of organisation, decision-making and allocation of financial resources in several stages, with the involvement of partners in accordance with Article 5, intended to implement, on a multi-annual basis, joint action by the Union and the Member States to achieve the objectives of the Union strategy for smart, sustainable and inclusive growth
programme area means a geographical area covered by a specific programme or, in the case of a programme covering more than one category of region, the geographical area corresponding to each separate category of region
operation means a project, contract, action or group of projects selected by the managing authorities of the programmes concerned, or under their responsibility, that contributes to the objectives of a priority or priorities; in the context of financial instruments, an operation is constituted by the financial contributions from a programme to financial instruments and the subsequent financial support provided by those financial instruments
beneficiary means a public or private body or a natural person, responsible for initiating or both initiating and implementing operations, and:
(a) in the context of State aid, the body which receives the aid, except where the aid per undertaking is less than EUR 200 000 , in which case the Member State concerned may decide that the beneficiary is the body granting the aid, without prejudice to Commission Regulations (EU) No 1407/2013, (EU) No 1408/2013 and (EU) No 717/2014; and
(b) in the context of financial instruments under Title IV of Part Two of this Regulation, the body that implements the financial instrument or the fund of funds as appropriate
final recipient means a legal or natural person receiving financial support from a financial instrument
completed operation means an operation that has been physically completed or fully implemented and in respect of which all related payments have been made by beneficiaries and the corresponding public contribution has been paid to the beneficiaries
public expenditure means any public contribution to the financing of operations the source of which is the budget of national, regional or local public authorities, the budget of the Union related to the ESI Funds, the budget of public law bodies or the budget of associations of public authorities or of public law bodies and, for the purpose of determining the co-financing rate for ESF programmes or priorities, may include any financial resources collectively contributed by employers and workers
intermediate body means any public or private body which acts under the responsibility of a managing or certifying authority, or which carries out duties on behalf of such an authority, in relation to beneficiaries implementing operations
community-led local development strategy means a coherent set of operations the purpose of which is to meet local objectives and needs, and which contributes to achieving the Union strategy for smart, sustainable and inclusive growth, and which is designed and implemented by a local action group
Partnership Agreement means a document prepared by a Member State with the involvement of partners in line with the multi-level governance approach, which sets out that Member State's strategy, priorities and arrangements for using the ESI Funds in an effective and efficient way so as to pursue the Union strategy for smart, sustainable and inclusive growth, and which is approved by the Commission following assessment and dialogue with the Member State concerned
category of regions means the categorisation of regions as 'less developed regions', 'transition regions' or 'more developed regions' in accordance with Article 90(2)
payment application means a payment application or declaration of expenditure submitted by the Member State to the Commission
EIB means the European Investment Bank, the European Investment Fund or any subsidiary of the European Investment Bank
Public private partnerships (PPPs) means forms of cooperation between public bodies and the private sector, which aim to improve the delivery of investments in infrastructure projects or other types of operations, delivering public services through risk sharing, pooling of private sector expertise or additional sources of capital
PPP operation means an operation which is implemented or intended to be implemented under a public-private-partnership structure
escrow account means a bank account covered by a written agreement between a managing authority or an intermediate body and the body implementing a financial instrument, or, in the case of a PPP operation, a written agreement between a public body beneficiary and the private partner approved by the managing authority or an intermediate body, set up specifically to hold funds to be paid out after the eligibility period in the case of a financial instrument, or during the eligibility period and/or after the eligibility period in the case of a PPP operation, exclusively for the purposes provided for in point (c) of Article 42(1), Article 42(2), Article 42(3) and Article 64, or a bank account set up on terms providing equivalent guarantees on the payments out of the funds
fund of funds means a fund set up with the objective of contributing support from a programme or programmes to several financial instruments. Where financial instruments are implemented through a fund of funds, the body implementing the fund of funds shall be considered to be the only beneficiary within the meaning of point 10 of this Article
macroregional strategy means an integrated framework agreed by the Council and, where appropriate, endorsed by the European Council, which may be supported by the ESI Funds among others, to address common challenges faced by a defined geographical area relating to Member States and third countries located in the same geographical area which thereby benefit from strengthened cooperation contributing to achievement of economic, social and territorial cohesion
sea basin strategy means a structured framework of cooperation in relation to a given geographical area, developed by Union institutions, Member States, their regions and where appropriate third countries sharing a sea basin; a sea basin strategy takes into account the geographic, climatic, economic and political specificities of the sea basin
applicable ex ante conditionality means a concrete and precisely pre-defined critical factor, which is a prerequisite for and has a direct and genuine link to, and direct impact on, the effective and efficient achievement of a specific objective for an investment priority or a Union priority
specific objective means the result to which an investment priority or Union priority contributes in a specific national or regional context through actions or measures undertaken within such a priority
irregularity means any breach of Union law, or of national law relating to its application, resulting from an act or omission by an economic operator involved in the implementation of the ESI Funds, which has, or would have, the effect of prejudicing the budget of the Union by charging an unjustified item of expenditure to the budget of the Union
economic operator means any natural or legal person or other entity taking part in the implementation of assistance from the ESI Funds, with the exception of a Member State exercising its prerogatives as a public authority
systemic irregularity means any irregularity, which may be of a recurring nature, with a high probability of occurrence in similar types of operations, which results from a serious deficiency in the effective functioning of a management and control system, including a failure to establish appropriate procedures in accordance with this Regulation and the Fund-specific rules
serious deficiency in the effective functioning of a management and control system means, for the purposes of implementation of the Funds and the EMFF under Part Four, a deficiency for which substantial improvements in the system are required, which exposes the Funds and the EMFF to a significant risk of irregularities, and the existence of which is incompatible with an unqualified audit opinion on the functioning of the management and control system
fishery products mean aquatic organisms resulting from any fishing activity or products derived therefrom, as listed in Annex I
aquaculture products mean aquatic organisms at any stage of their life cycle resulting from any aquaculture activity or products derived therefrom, as listed in Annex I
producer means any natural or legal person using means of production to obtain fishery or aquaculture products with a view to placing them on the market
fishery and aquaculture sector means the sector of the economy which comprises all activities of production, processing and marketing of fishery or aquaculture products
making available on the market means any supply of a fishery or aquaculture product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a fishery or aquaculture product on the Union market
retail means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, including distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets
Union waters means the waters under the sovereignty or jurisdiction of the Member States, with the exception of the waters adjacent to the territories listed in Annex II to the Treaty
marine biological resources means available and accessible living marine aquatic species, including anadromous and catadromous species during their marine life
fresh water biological resources means available and accessible living fresh water aquatic species
fishing vessel means any vessel equipped for commercial exploitation of marine biological resources or a blue fin tuna trap
Union fishing vessel means a fishing vessel flying the flag of a Member State and registered in the Union
entry to the fishing fleet means registration of a fishing vessel in the fishing vessel register of a Member State
maximum sustainable yield means the highest theoretical equilibrium yield that can be continuously taken on average from a stock under existing average environmental conditions without significantly affecting the reproduction process
precautionary approach to fisheries management as referred to in Article 6 of the UN Fish Stocks Agreement, means an approach according to which the absence of adequate scientific information should not justify postponing or failing to take management measures to conserve target species, associated or dependent species and non-target species and their environment
ecosystem-based approach to fisheries management means an integrated approach to managing fisheries within ecologically meaningful boundaries which seeks to manage the use of natural resources, taking account of fishing and other human activities, while preserving both the biological wealth and the biological processes necessary to safeguard the composition, structure and functioning of the habitats of the ecosystem affected, by taking into account the knowledge and uncertainties regarding biotic, abiotic and human components of ecosystems
discards means catches that are returned to the sea
low impact fishing means utilising selective fishing techniques which have a low detrimental impact on marine ecosystems or which may result in low fuel emissions, or both
selective fishing means fishing with fishing methods or fishing gears that target and capture organisms by size or species during the fishing operation, allowing non-target specimens to be avoided or released unharmed
fishing mortality rate means the rate at which biomass or individuals are removed from a stock by means of fishery activities over a given period
stock means a marine biological resource that occurs in a given management area
catch limit means, as appropriate, either a quantitative limit on catches of a fish stock or group of fish stocks over a given period where such fish stocks or group of fish stocks are subject to an obligation to land, or a quantitative limit on landings of a fish stock or group of fish stocks over a given period for which the obligation to land does not apply
conservation reference point means values of fish stock population parameters (such as biomass or fishing mortality rate) used in fisheries management, for example in respect of an acceptable level of biological risk or a desired level of yield
minimum conservation reference size means the size of a living marine aquatic species taking into account maturity, as established by Union law, below which restrictions or incentives apply that aim to avoid capture through fishing activity; such size replaces, where relevant, the minimum landing size
stock within safe biological limits means a stock with a high probability that its estimated spawning biomass at the end of the previous year is higher than the limit biomass reference point (Blim) and its estimated fishing mortality rate for the previous year is less than the limit fishing mortality rate reference point (Flim)
safeguard means a precautionary measure designed to avoid something undesirable occurring
technical measure means a measure that regulates the composition of catches by species and size and the impacts on components of the ecosystems resulting from fishing activities by establishing conditions for the use and structure of fishing gear and restrictions on access to fishing areas
fishing effort means the product of the capacity and the activity of a fishing vessel; for a group of fishing vessels it is the sum of the fishing effort of all vessels in the group
Member State having a direct management interest means a Member State which has an interest consisting of either fishing opportunities or a fishery taking place in the exclusive economic zone of the Member State concerned, or, in the Mediterranean Sea, a traditional fishery on the high seas
transferable fishing concession means a revocable user entitlement to a specific part of fishing opportunities allocated to a Member State or established in a management plan adopted by a Member State in accordance with Article 19 of Council Regulation (EC) No 1967/2006, which the holder may transfer
fishing capacity means a vessel's tonnage in GT (Gross Tonnage) and its power in kW (Kilowatt) as defined in Articles 4 and 5 of Council Regulation (EEC) No 2930/86
aquaculture means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of the organisms in question beyond the natural capacity of the environment, where the organisms remain the property of a natural or legal person throughout the rearing and culture stage, up to and including harvesting
fishing activity means searching for fish, shooting, setting, towing, hauling of a fishing gear, taking catch on board, transhipping, retaining on board, processing on board, transferring, caging, fattening and landing of fish and fishery products
fishery products means aquatic organisms resulting from any fishing activity or products derived therefrom
operator means the natural or legal person who operates or holds any undertaking carrying out any of the activities related to any stage of production, processing, marketing, distribution and retail chains of fisheries and aquaculture products
end-user of scientific data means a body with a research or management interest in the scientific analysis of data in the fisheries sector
surplus of allowable catch means that part of the allowable catch which a coastal State does not harvest, resulting in an overall exploitation rate for individual stocks that remains below levels at which stocks are capable of restoring themselves and maintaining populations of harvested species above desired levels based on the best available scientific advice
aquaculture products means aquatic organisms at any stage of their life cycle resulting from any aquaculture activity or products derived therefrom
spawning stock biomass means an estimate of the mass of the fish of a particular stock that reproduces at a defined time, including both males and females and fish that reproduce viviparously
mixed fisheries means fisheries in which more than one species is present and where different species are likely to be caught in the same fishing operation
sustainable fisheries partnership agreement means an international agreement concluded with a third state for the purpose of obtaining access to waters and resources in order to sustainably exploit a share of the surplus of marine biological resources, in exchange for financial compensation from the Union, which may include sectoral support
air border surveillance means the surveillance of any flight of a manned or unmanned aircraft and its passengers or cargo to or from the territory of the Member States which is not an internal flight as defined in point 3 of Article 2 of Regulation (EU) 2016/399
situational awareness means the ability to monitor, detect, identify, track and understand illegal cross-border activities in order to find reasoned grounds for reaction measures on the basis of combining new information with existing knowledge, and to be better able to reduce the loss of lives of migrants at, along or in the proximity of the external borders
reaction capability means the ability to perform actions aimed at countering illegal cross-border activities at, along or in the proximity of the external borders, including the means and timelines to react adequately
EUROSUR means the framework for information exchange and cooperation between the Member States and the European Border and Coast Guard Agency
situational picture means an aggregation of geo-referenced near-real-time data and information received from different authorities, sensors, platforms and other sources which is transmitted across secured communication and information channels and can be processed and selectively displayed and shared with other relevant authorities in order to achieve situational awareness and support the reaction capability at, along or in the proximity of the external borders and the pre-frontier area
external border section means the whole or a part of the external border of a Member State, as defined by national law or as determined by the national coordination centre or any other responsible national authority
cross-border crime means any serious crime with a cross-border dimension that is committed or attempted at, along or in the proximity of the external borders
pre-frontier area means the geographical area beyond the external borders which is relevant for managing the external borders through risk analysis and situational awareness
incident means a situation relating to illegal immigration, cross-border crime, or a risk to the lives of migrants at, along or in the proximity of, the external borders
statutory staff means staff employed by the European Border and Coast Guard Agency in accordance with the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68
operational staff means border guards, return escorts, return specialists and other relevant staff constituting the European Border and Coast Guard standing corps in accordance with the four categories set out in Article 54(1), acting as members of the teams having executive powers, where applicable, and the statutory staff responsible for the functioning of the European Travel Information and Authorisation System (ETIAS) Central Unit that are not deployable as members of the teams
member of the teams means a member of the European Border and Coast Guard standing corps deployed through border management teams, migration management support teams and return teams
border management teams means teams formed from the European Border and Coast Guard standing corps to be deployed during joint operations at the external borders and rapid border interventions in Member States and third countries
migration management support teams means teams of experts which provide technical and operational reinforcement to Member States, including at hotspot areas, composed of operational staff, experts from the European Asylum Support Office (EASO) and Europol and, where relevant, experts from the European Union Agency for Fundamental Rights (FRA), other Union bodies, offices and agencies and Member States
host Member State means a Member State in which a joint operation or a rapid border intervention, a return operation or a return intervention takes place, or from which it is launched, or in which a migration management support team is deployed
home Member State means the Member State from which a staff member is deployed or seconded to the European Border and Coast Guard standing corps
participating Member State means a Member State which participates in a joint operation, rapid border intervention, return operation, return intervention or in a deployment of a migration management support team, by providing technical equipment or staff of the European Border and Coast Guard standing corps, as well as a Member State which participates in return operations or return interventions by providing technical equipment or staff, but which is not a host Member State
hotspot area means an area created at the request of the host Member State in which the host Member State, the Commission, relevant Union agencies and participating Member States cooperate, with the aim of managing an existing or potential disproportionate migratory challenge characterised by a significant increase in the number of migrants arriving at the external borders
return decision means an administrative or judicial decision or act stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return that respects Directive 2008/115/EC
returnee means an illegally staying third-country national who is the subject of an enforceable return decision
return operation means an operation that is organised or coordinated by the European Border and Coast Guard Agency and involves technical and operational reinforcement provided to one or more Member States under which returnees from one or more Member States are returned, either on a forced or voluntary basis, irrespective of the means of transport
return intervention means an activity of the European Border and Coast Guard Agency providing Member States with enhanced technical and operational assistance consisting of the deployment of return teams and the organisation of return operations
return teams means teams formed from the European Border and Coast Guard standing corps to be deployed during return operations, return interventions in Member States or other operational activities linked to the implementation of return-related tasks
Power transformer means a static piece of apparatus with two or more windings which, by electromagnetic induction, transforms a system of alternating voltage and current into another system of alternating voltage and current usually of different values and at the same frequency for the purpose of transmitting electrical power
Small power transformer means a power transformer with a highest voltage for equipment not exceeding 1,1 kV
medium power transformer means a power transformer with all windings having rated power lower than or equal to 3 150 kVA, and highest voltage for equipment greater than 1,1 kV and lower than or equal to 36 kV
Large power transformer means a power transformer with at least one winding having either rated power greater than 3 150 kVA or highest voltage for equipment greater than 36 kV
Liquid-immersed transformer means a power transformer in which the magnetic circuit and windings are immersed in liquid
Dry-type transformer means a power transformer in which the magnetic circuit and windings are not immersed in an insulating liquid
Medium power pole-mounted transformer means a power transformer with a rated power of up to 400 kVA suitable for outdoor service and specifically designed to be mounted on the support structures of overhead power lines
Voltage Regulation Distribution Transformer means a medium power transformer equipped with additional components, inside or outside of the transformer tank, to automatically control the input or output voltage of the transformer for on-load voltage regulation purposes
Winding refers to the assembly of turns forming an electrical circuit associated with one of the voltages assigned to the transformer
Rated voltage of a winding (Ur) is the voltage assigned to be applied, or developed at no-load, between the terminals of an untapped winding, or of a tapped winding connected on the principal tapping
High-voltage winding refers to the winding having the highest rated voltage
Highest voltage for equipment (Um) applicable to a transformer winding is the highest r.m.s phase-to-phase voltage in a three-phase system for which a transformer winding is designed in respect of its insulation
Rated power (Sr) is a conventional value of apparent power assigned to a winding which, together with the rated voltage of the winding, determines its rated current
Load loss (Pk) means the absorbed active power at rated frequency and reference temperature associated with a pair of windings when the rated current (tapping current) is flowing through the line terminal(s) of one of the windings and the terminals of the other windings are in short-circuit with any winding fitted with tappings connected to its principal tapping, while further windings, if existing, are open-circuited
No load loss (Po) means the active power absorbed at rated frequency when the transformer is energised and the secondary circuit is open. The applied voltage is the rated voltage, and if the energized winding is fitted with a tapping, it is connected to its principal tapping
Peak Efficiency Index (PEI) means the maximum value of the ratio of the transmitted apparent power of a transformer minus the electrical losses to the transmitted apparent power of the transformer
Dual voltage transformer means a transformer with one or more windings with two voltages available in order to be able to operate and supply rated power at either of two different voltage values
Witnessed testing means actively observing the physical testing of the product under investigation by another party, to draw conclusions on the validity of the test and the test results. This may include conclusions on the compliance of testing and calculations methods used with applicable standards and legislation
Factory acceptance test means a test on an ordered product where the customer uses witnessed testing to verify the product’s full accordance with contractual requirements, before they are accepted or put into service
Equivalent model means a model which has the same technical characteristics relevant for the technical information to be provided, but which is placed on the market or put into service by the same manufacturer or importer as another model with a different model identifier
Model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer’s or importer’s name
aeroplane means an engine-driven fixed-wing aircraft heavier than air that is supported in flight by the dynamic reaction of the air against its wings
helicopter means a heavier-than-air aircraft supported in flight chiefly by the reactions of the air on one or more power-driven rotors on substantially vertical axes
balloon means a manned lighter-than-air aircraft which is not power-driven and sustains flight through the use of either a lighter-than-air gas or an airborne heater, including gas balloons, hot-air balloons, mixed balloons and, although power-driven, hot-air airship
sailplane means a heavier-than-air aircraft that is supported in flight by the dynamic reaction of the air against its fixed lifting surfaces, the free flight of which does not depend on an engine
commercial operation means any operation of an aircraft, in return for remuneration or other valuable consideration, which is available for the public or, when not made available to the public, which is performed under a contract between an operator and a customer, where the latter has no control over the operator
tethered gas balloon means a gas balloon with a tether system that continuously anchors the balloon to a fixed point during operation
performance class B aeroplanes means aeroplanes powered by propeller engines with a maximum operational passenger seating configuration of nine or less and a maximum take-off mass of 5 700 kg or less
public interest site (PIS) means a site used exclusively for operations in the public interest
operation in performance class 1 means an operation that, in the event of failure of the critical engine, the helicopter is able to land within the rejected take-off distance available or safely continue the flight to an appropriate landing area, depending on when the failure occurs
performance-based navigation (PBN) means area navigation based on performance requirements for aircraft operating along an ATS route, on an instrument approach procedure or in a designated airspace
air taxi operation means, for the purpose of flight time and duty time limitations, a non-scheduled on demand commercial air transport operation with an aeroplane with a maximum operational passenger seating configuration (‘MOPSC’) of 19 or less
specialised operation means any operation, other than commercial air transport operation, where the aircraft is used for specialised activities such as agriculture, construction, photography, surveying, observation and patrol, aerial advertisement, maintenance check flights
high risk commercial specialised operation means any commercial specialised aircraft operation carried out over an area where the safety of third parties on the ground is likely to be endangered in the event of an emergency, or, as determined by the competent authority of the place where the operation is conducted, any commercial specialised aircraft operation that, due to its specific nature and the local environment in which it is conducted, poses a high risk, in particular to third parties on the ground
introductory flight means any operation against remuneration or other valuable consideration consisting of an air tour of short duration for the purpose of attracting new trainees or new members, performed either by a training organisation referred to in Article 10a of Commission Regulation (EU) No 1178/2011 or by an organisation created with the aim of promoting aerial sport or leisure aviation
competition flight means any flying activity where the aircraft is used in air races or contests, as well as where the aircraft is used to practice for air races or contests and to fly to and from racing or contest events
flying display means any flying activity deliberately performed for the purpose of providing an exhibition or entertainment at an advertised event open to the public, including where the aircraft is used to practice for a flying display and to fly to and from the advertised event
accelerate-stop distance available (ASDA) means the length of the take-off run available plus the length of stopway, if such stopway is declared available by the State of the aerodrome and is capable of bearing the mass of the aeroplane under the prevailing operating conditions
acceptable means of compliance (AMC) means non-binding standards adopted by the Agency to illustrate means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules
acceptance checklist means a document used to assist in carrying out a check on the external appearance of packages of dangerous goods and their associated documents to determine that all appropriate requirements have been met with
adequate aerodrome means an aerodrome on which the aircraft can be operated, taking account of the applicable performance requirements and runway characteristics
aided night vision imaging system (NVIS) flight means, in the case of NVIS operations, that portion of a visual flight rules (VFR) flight performed at night when a crew member is using night vision goggles (NVG)
aircraft means a machine that can derive support in the atmosphere from the reactions of the air other than the reactions of the air against the earth’s surface
aircraft tracking means a ground based process that maintains and updates, at standardised intervals, a record of the four dimensional position of individual aircraft in flight
aircraft tracking system means a system that relies on aircraft tracking in order to identify abnormal flight behaviour and provide alert
alternative means of compliance means those means that propose an alternative to an existing acceptable means of compliance or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency
anti-icing in the case of ground procedures, means a procedure that provides protection against the formation of frost or ice and accumulation of snow on treated surfaces of the aircraft for a limited period of time (hold-over time)
approach procedure with vertical guidance (APV) operation means an instrument approach which utilises lateral and vertical guidance, but does not meet the requirements established for precision approach and landing operations, with a decision height (DH) not lower than 250 ft and a runway visual range (RVR) of not less than 600 m
cabin crew member means an appropriately qualified crew member, other than a flight crew or technical crew member, who is assigned by an operator to perform duties related to the safety of passengers and flight during operations
category I (CAT I) approach operation means a precision instrument approach and landing using an instrument landing system (ILS), microwave landing system (MLS), GLS (ground-based augmented global navigation satellite system (GNSS/GBAS) landing system), precision approach radar (PAR) or GNSS using a satellite-based augmentation system (SBAS) with a decision height (DH) not lower than 200 ft and with a runway visual range (RVR) not less than 550 m for aeroplanes and 500 m for helicopters
category II (CAT II) operation means a precision instrument approach and landing operation using ILS or MLS with:
(a) DH below 200 ft but not lower than 100 ft; and
(b) RVR of not less than 300 m
category IIIA (CAT IIIA) operation means a precision instrument approach and landing operation using ILS or MLS with:
(a) DH lower than 100 ft; and
(b) RVR not less than 200 m
category IIIB (CAT IIIB) operation means a precision instrument approach and landing operation using ILS or MLS with:
(a) DH lower than 100 ft, or no DH; and
(b) RVR lower than 200 m but not less than 75 m
category A with respect to helicopters means a multi-engined helicopter designed with engine and system isolation features specified in the applicable certification specification and capable of operations using take-off and landing data scheduled under a critical engine failure concept that assures adequate designated surface area and adequate performance capability for continued safe flight or safe rejected take-off in the event of engine failure
category B with respect to helicopters means a single-engined or multi-engined helicopter that does not meet category A standards. Category B helicopters have no guaranteed capability to continue safe flight in the event of an engine failure, and unscheduled landing is assumed
certification specifications (CS) means technical standards adopted by the Agency indicating means to show compliance with Regulation (EC) No 216/2008 and its Implementing Rules and which can be used by an organisation for the purpose of certification
circling means the visual phase of an instrument approach to bring an aircraft into position for landing on a runway/FATO that is not suitably located for a straight-in approach
clearway means a defined rectangular area on the ground or water under the control of the appropriate authority, selected or prepared as a suitable area over which an aeroplane may make a portion of its initial climb to a specified height
cloud base means the height of the base of the lowest observed or forecast cloud element in the vicinity of an aerodrome or operating site or within a specified area of operations, normally measured above aerodrome elevation or, in the case of offshore operations, above mean sea level
cockpit voice recorder (CVR) means a crash-protected flight recorder that uses a combination of microphones and other audio and digital inputs to collect and record the aural environment of the flight crew compartment and communications to, from and between the flight crew members
code share means an arrangement under which an operator places its designator code on a flight operated by another operator, and sells and issues tickets for that flight
congested area means in relation to a city, town or settlement, any area which is substantially used for residential, commercial or recreational purposes
contaminated runway means a runway of which a significant portion of its surface area (whether in isolated areas or not) within the length and width being used is covered by one or more of the substances listed under the runway surface condition descriptor
contingency fuel means the fuel required to compensate for unforeseen factors that could have an influence on the fuel consumption to the destination aerodrome
continuous descent final approach (CDFA) means a technique, consistent with stabilised approach procedures, for flying the final-approach segment of a non-precision instrument approach procedure as a continuous descent, without level-off, from an altitude/height at or above the final approach fix altitude/height to a point approximately 15 m (50 ft) above the landing runway threshold or the point where the flare manoeuvre shall begin for the type of aircraft flown
converted meteorological visibility (CMV) means a value, equivalent to an RVR, which is derived from the reported meteorological visibility
crew member means a person assigned by an operator to perform duties on board an aircraft
critical phases of flight in the case of aeroplanes means the take-off run, the take-off flight path, the final approach, the missed approach, the landing, including the landing roll, and any other phases of flight as determined by the pilot-in-command or commander
critical phases of flight in the case of helicopters means taxiing, hovering, take-off, final approach, missed approach, the landing and any other phases of flight as determined by the pilot-in-command or commander
dangerous goods (DG) means articles or substances which are capable of posing a risk to health, safety, property or the environment and which are shown in the list of dangerous goods in the technical instructions or which are classified according to those instructions
dangerous goods accident means an occurrence associated with and related to the transport of dangerous goods by air which results in fatal or serious injury to a person or major property damage
dangerous goods incident means:
(a) an occurrence other than a dangerous goods accident associated with and related to the transport of dangerous goods by air, not necessarily occurring on board an aircraft, which results in injury to a person, property damage, fire, breakage, spillage, leakage of fluid or radiation or other evidence that the integrity of the packaging has not been maintained;
(b) any occurrence relating to the transport of dangerous goods which seriously jeopardises an aircraft or its occupants
de-icing in the case of ground procedures, means a procedure by which frost, ice, snow or slush is removed from an aircraft in order to provide uncontaminated surfaces
defined point after take-off (DPATO) means the point, within the take-off and initial climb phase, before which the helicopter’s ability to continue the flight safely, with the critical engine inoperative, is not assured and a forced landing may be required
defined point before landing (DPBL) means the point within the approach and landing phase, after which the helicopter’s ability to continue the flight safely, with the critical engine inoperative, is not assured and a forced landing may be require
distance DR means the horizontal distance that the helicopter has travelled from the end of the take-off distance available
dry lease agreement means an agreement between undertakings pursuant to which the aircraft is operated under the air operator certificate (AOC) of the lessee or, in the case of commercial operations other than CAT, under the responsibility of the lessee
dry operating mass means the total mass of the aircraft ready for a specific type of operation, excluding usable fuel and traffic load
dry runway means a runway whose surface is free of visible moisture and not contaminated within the area intended to be used
EFB application means a software application installed on an EFB host platform that provides one or more specific operational functions which support flight operations
EFB host platform means the hardware equipment in which the computing capabilities and basic software reside, including the operating system and the input/output software
EFB system means the hardware equipment (including any battery, connectivity provisions, input/output components) and software (including databases and the operating system) needed to support the intended EFB application(s)
ELA1 aircraft means the following manned European Light Aircraft:
(a) an aeroplane with a Maximum Take-off Mass (MTOM) of 1 200 kg or less that is not classified as complex motor-powered aircraft;
(b) a sailplane or powered sailplane of 1 200 kg MTOM or less;
(c) a balloon with a maximum design lifting gas or hot air volume of not more than 3 400 m3 for hot air balloons, 1 050 m3 for gas balloons, 300 m3 for tethered gas balloons
ELA2 aircraft means the following manned European Light Aircraft:
(a) an aeroplane with a Maximum Take-off Mass (MTOM) of 2 000 kg or less that is not classified as complex motor-powered aircraft;
(b) a sailplane or powered sailplane of 2 000 kg MTOM or less;
(c) a balloon;
(d) a Very Light Rotorcraft with a MTOM not exceeding 600 kg which is of a simple design, designed to carry not more than two occupants, not powered by turbine and/or rocket engines; restricted to VFR day operations
electronic flight bag (EFB) means an electronic information system, comprised of equipment and applications for flight crew, which allows for the storing, updating, displaying and processing of EFB functions to support flight operations or duties
elevated final approach and take-off area (elevated FATO) means a FATO that is at least 3 m above the surrounding surface
emergency exit means an installed exit-type egress point from the aircraft that allows maximum opportunity for cabin and flight crew compartment evacuation within an appropriate time period and includes floor level door, window exit or any other type of exit, for instance hatch in the flight crew compartment and tail cone exit
en-route alternate (ERA) aerodrome means an adequate aerodrome along the route, which may be required at the planning stage
enhanced vision system (EVS) means a system to display electronic real-time images of the external scene achieved through the use of imaging sensors
final approach and take-off area (FATO) means a defined area for helicopter operations, over which the final phase of the approach manoeuvre to hover or land is completed, and from which the take-off manoeuvre is commenced. In the case of helicopters operating in performance class 1, the defined area includes the rejected take-off area available
flight crew member means a licensed crew member charged with duties essential to the operation of an aircraft during a flight duty period
flight data monitoring (FDM) means the proactive and non-punitive use of digital flight data from routine operations to improve aviation safety
flight operations officer or flight dispatcher means a person designated by the operator to engage in the control and supervision of flight operations, who is suitably qualified, who supports, briefs or assists, or both, the pilot-in-command in the safe conduct of the flight
flight data recorder (FDR) means a crash-protected flight recorder that uses a combination of data sources to collect and record parameters that reflect the state and performance of the aircraft
flight recorder means any type of recorder that is installed on the aircraft for the purpose of facilitating accident or incident safety investigations
flight simulation training device (FSTD) means a training device which is:
(a) in the case of aeroplanes, a full flight simulator (FFS), a flight training device (FTD), a flight and navigation procedures trainer (FNPT), or a basic instrument training device (BITD);
(b) in the case of helicopters, a full flight simulator (FFS), a flight training device (FTD) or a flight and navigation procedures trainer (FNPT)
fuel ERA aerodrome means an ERA aerodrome selected for the purpose of reducing contingency fuel
GBAS landing system (GLS) means an approach landing system using ground based augmented global navigation satellite system (GNSS/GBAS) information to provide guidance to the aircraft based on its lateral and vertical GNSS position. It uses geometric altitude reference for its final approach slope
ground emergency service personnel means any ground emergency service personnel (such as policemen, firemen, etc.) involved with helicopter emergency medical services (HEMSs) and whose tasks are to any extent pertinent to helicopter operations
grounding means the formal prohibition of an aircraft to take-off and the taking of such steps as are necessary to detain it
head-up display (HUD) means a display system which presents flight information to the pilot’s forward external field of view and which does not significantly restrict the external view
head-up guidance landing system (HUDLS) means the total airborne system that provides head-up guidance to the pilot during the approach and landing and/or missed approach procedure. It includes all sensors, computers, power supplies, indications and controls
helicopter hoist operation (HHO) crew member means a technical crew member who performs assigned duties relating to the operation of a hoist
helideck means a FATO located on a floating or fixed offshore structure
HEMS crew member means a technical crew member who is assigned to a HEMS flight for the purpose of attending to any person in need of medical assistance carried in the helicopter and assisting the pilot during the mission
HEMS flight means a flight by a helicopter operating under a HEMS approval, the purpose of which is to facilitate emergency medical assistance, where immediate and rapid transportation is essential, by carrying:
(a) medical personnel;
(b) medical supplies (equipment, blood, organs, drugs); or
(c) ill or injured persons and other persons directly involved
EMS operating base means an aerodrome at which the HEMS crew members and the HEMS helicopter may be on stand-by for HEMS operations
HEMS operating site means a site selected by the commander during a HEMS flight for helicopter hoist operations, landing and take-off
HHO flight means a flight by a helicopter operating under an HHO approval, the purpose of which is to facilitate the transfer of persons and/or cargo by means of a helicopter hoist
HHO offshore means a flight by a helicopter operating under an HHO approval, the purpose of which is to facilitate the transfer of persons and/or cargo by means of a helicopter hoist from or to a vessel or structure in a sea area or to the sea itself
HHO passenger means a person who is to be transferred by means of a helicopter hoist
HHO site means a specified area at which a helicopter performs a hoist transfer
hold-over time (HoT) means the estimated time the anti-icing fluid will prevent the formation of ice and frost and the accumulation of snow on the protected (treated) surfaces of an aeroplane
hostile environment means:
(a) an area in which:
(i) a safe forced landing cannot be accomplished because the surface is inadequate; or
(ii) the helicopter occupants cannot be adequately protected from the elements; or
(iii) search and rescue response/capability are not provided consistent with anticipated exposure; or
(iv) there is an unacceptable risk of endangering persons or property on the ground;
(b) in any case, the following areas:
(i) for overwater operations, the open sea area north of 45 N and south of 45 S, unless any part is designated as non-hostile by the responsible authority of the State in which the operations take place; and
(ii) those parts of a congested area without adequate safe forced landing areas
human–machine interface (HMI) means a component of certain devices that is capable of handling human–machine interactions. The interface consists of hardware and software that allow user inputs to be interpreted and processed by machines or systems that, in turn, provide the required results to the user
landing decision point (LDP) means the point used in determining landing performance from which, an engine failure having been recognised at this point, the landing may be safely continued or a balked landing initiated
landing distance at time of arrival (LDTA) means a landing distance that is achievable in normal operations based on landing performance data and associated procedures determined for the prevailing conditions at the time of landing
landing distance available (LDA) means the length of the runway which is declared available by the State of the aerodrome and suitable for the ground run of an aeroplane landing
landplane means a fixed wing aircraft which is designed for taking off and landing on land and includes amphibians operated as landplanes
local helicopter operation means a commercial air transport operation of helicopters with a maximum certified take-off mass (MCTOM) over 3 175 kg and a maximum operational passenger seating configuration (MOPSC) of nine or less, by day, over routes navigated by reference to visual landmarks, conducted within a local and defined geographical area specified in the operations manual
low visibility procedures (LVP) means procedures applied at an aerodrome for the purpose of ensuring safe operations during lower than standard category I, other than standard category II, category II and III approaches and low visibility take-offs
low visibility take-off (LVTO) means a take-off with an RVR lower than 400 m but not less than 75 m
lower than standard category I (LTS CAT I) operation means a category I instrument approach and landing operation using category I DH, with an RVR lower than would normally be associated with the applicable DH but not lower than 400 m
maintenance check flight (MCF) means a flight of an aircraft with an airworthiness certificate or with a permit to fly which is carried out for troubleshooting purposes or to check the functioning of one or more systems, parts or appliances after maintenance, if the functioning of the systems, parts or appliances cannot be established during ground checks and which is carried out in any of the following situations:
(a) as required by the aircraft maintenance manual (‘AMM’) or any other maintenance data issued by a design approval holder being responsible for the continuing airworthiness of the aircraft;
(b) after maintenance, as required by the operator or proposed by the organisation responsible for the continuing airworthiness of the aircraft;
(c) as requested by the maintenance organisation for verification of a successful defect rectification;
(d) to assist with fault isolation or troubleshooting
maximum operational passenger seating configuration (MOPSC) means the maximum passenger seating capacity of an individual aircraft, excluding crew seats, established for operational purposes and specified in the operations manual. Taking as a baseline the maximum passenger seating configuration established during the certification process conducted for the type certificate (TC), supplemental type certificate (STC) or change to the TC or STC as relevant to the individual aircraft, the MOPSC may establish an equal or lower number of seats, depending on the operational constraints
medical passenger means a medical person carried in a helicopter during a HEMS flight, including but not limited to doctors, nurses and paramedics
minor failure condition means a failure condition that would not significantly reduce aircraft safety, and which involves flight crew actions that are well within their capabilities
misuse of substances means the use of one or more psychoactive substances by flight crew, cabin crew members and other safety-sensitive personnel in a way that:
(a) constitutes a direct hazard to the user or endangers the lives, health or welfare of others; and/or
(b) causes or worsens an occupational, social, mental or physical problem or disorder
night means the period between the end of evening civil twilight and the beginning of morning civil twilight or such other period between sunset and sunrise as may be prescribed by the appropriate authority, as defined by the Member State
night vision goggles (NVG) means a head-mounted, binocular, light intensification appliance that enhances the ability to maintain visual surface references at night
night vision imaging system (NVIS) means the integration of all elements required to successfully and safely use NVGs while operating a helicopter. The system includes as a minimum: NVGs, NVIS lighting, helicopter components, training and continuing airworthiness
non-hostile environment means an environment in which:
(a) a safe forced landing can be accomplished;
(b) the helicopter occupants can be protected from the elements; and
(c) search and rescue response/capability is provided consistent with the anticipated exposure.
In any case, those parts of a congested area with adequate safe forced landing areas shall be considered non-hostile
non-precision approach (NPA) operation means an instrument approach with a minimum descent height (MDH), or DH when flying a CDFA technique, not lower than 250 ft and an RVR/CMV of not less than 750 m for aeroplanes and 600 m for helicopters
NVIS crew member means a technical crew member assigned to an NVIS flight
NVIS flight means a flight under night visual meteorological conditions (VMC) with the flight crew using NVGs in a helicopter operating under an NVIS approval
offshore operation means a helicopter operation that has a substantial proportion of any flight conducted over open sea areas to or from an offshore location
offshore location means a facility intended to be used for helicopter operations on a fixed or floating offshore structure or a vessel
open sea area means the area of water to seaward of the coastline
operating site means a site, other than an aerodrome, selected by the operator or pilot-in-command or commander for landing, take-off and/or external load operations
operation in performance class 1 means an operation that, in the event of failure of the critical engine, the helicopter is able to land within the rejected take-off distance available or safely continue the flight to an appropriate landing area, depending on when the failure occurs
operation in performance class 2 means an operation that, in the event of failure of the critical engine, performance is available to enable the helicopter to safely continue the flight, except when the failure occurs early during the
operation in performance class 3 means an operation that, in the event of an engine failure at any time during the flight, a forced landing may be required in a multi-engined helicopter and will be required in a single-engined helicopter
operational control means the responsibility for the initiation, continuation, termination or diversion of a flight in the interest of safety
other than standard category II (OTS CAT II) operation means a precision instrument approach and landing operation using ILS or MLS where some or all of the elements of the precision approach category II light system are not available, and with:
(a) DH below 200 ft but not lower than 100 ft; and
(b) RVR of not less than 350 m
performance class A aeroplanes means multi-engined aeroplanes powered by turbo-propeller engines with an MOPSC of more than nine or a maximum take-off mass exceeding 5 700 kg, and all multi-engined turbo-jet powered aeroplanes
performance class B aeroplanes means aeroplanes powered by propeller engines with an MOPSC of nine or less and a maximum take-off mass of 5 700 kg or less
performance class C aeroplanes means aeroplanes powered by reciprocating engines with an MOPSC of more than nine or a maximum take-off mass exceeding 5 700 kg
personnel-carrying device system (PCDS) means a system including one or more devices that is either attached to a hoist or cargo hook or mounted to the rotorcraft airframe during human external cargo (HEC) or helicopter hoist operations (HHO). The devices have the structural capability and features needed to transport occupants external to the helicopter e.g. a life safety harness with or without a quick release and strop with a connector ring, a rigid basket or a cage
simple personnel carrying device system (simple PCDS) means a PCDS that complies with the following conditions:
(a) meets a harmonised standard under Regulation (EU) 2016/425 of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament and of the Council;
(b) is designed to restrain no more than a single person (for instance, hoist or cargo hook operator, task specialist or photographer) inside the cabin, or to restrain no more than two persons outside the cabin;
(c) is not a rigid structure such as a cage, a platform or a basket
pilot-in-command means the pilot designated as being in command and charged with the safe conduct of the flight. For the purpose of commercial air transport operations, the ‘pilot-in-command’ shall be termed the ‘commander’
portable EFB means a portable EFB host platform, used on the flight deck, which is not part of the configuration of the certified aircraft
portable electronic device (PED) means any kind of electronic device, typically but not limited to consumer electronics, brought on board the aircraft by crew members, passengers, or as part of the cargo, that is not included in the configuration of the certified aircraft. It includes all equipment that is able to consume electrical energy. The electrical energy can be provided from internal sources such as batteries (chargeable or non-rechargeable) or the devices may also be connected to specific aircraft power sources
principal place of business means the head office or registered office of the organisation within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised
prioritisation of ramp inspections means the dedication of an appropriate portion of the total number of ramp inspections conducted by or on behalf of a competent authority on an annual basis as provided in Part-ARO
public interest site (PIS) means a site used exclusively for operations in the public interest
ramp inspection means the inspection of aircraft, of flight and cabin crew qualifications and of flight documentation in order to verify the compliance with the applicable requirements
rectification interval means a limitation on the duration of operations with inoperative equipment
rejected take-off distance available (RTODAH) means the length of the final approach and take-off area declared available and suitable for helicopters operated in performance class 1 to complete a rejected take-off
rejected take-off distance required (RTODRH) means the horizontal distance required from the start of the take-off to the point where the helicopter comes to a full stop following an engine failure and rejection of the take-off at the take-off decision point
required navigation performance (RNP) specification means a navigation specification for PBN operations which includes a requirement for on-board navigation performance monitoring and alerting
runway condition report (RCR) means a comprehensive standardised report relating to the conditions of the runway surface and their effect on the aeroplane landing and take-off performance, described by means of runway conditions code
runway visual range (RVR) means the range over which the pilot of an aircraft on the centre line of a runway can see the runway surface markings or the lights delineating the runway or identifying its centre line
safe forced landing means an unavoidable landing or ditching with a reasonable expectancy of no injuries to persons in the aircraft or on the surface
seaplane means a fixed wing aircraft which is designed for taking off and landing on water and includes amphibians operated as seaplanes
separate runways means runways at the same aerodrome that are separate landing surfaces. These runways may overlay or cross in such a way that if one of the runways is blocked, it will not prevent the planned type of operations on the other runway. Each runway shall have a separate approach procedure based on a separate navigation aid
specially prepared winter runway means a runway with a dry frozen surface of compacted snow or ice which has been treated with sand or grit or has been mechanically treated to improve runway friction
special VFR flight means a VFR flight cleared by air traffic control to operate within a control zone in meteorological conditions below VMC
stabilised approach (SAp) means an approach that is flown in a controlled and appropriate manner in terms of configuration, energy and control of the flight path from a pre-determined point or altitude/height down to a point 50 ft above the threshold or the point where the flare manoeuvre is initiated if higher
sterile flight crew compartment means any period of time when the flight crew members are not disturbed or distracted, except for matters critical to the safe operation of the aircraft or the safety of the occupants
take-off alternate aerodrome means an alternate aerodrome at which an aircraft can land should this become necessary shortly after take-off and if it is not possible to use the aerodrome of departure
take-off decision point (TDP) means the point used in determining take-off performance from which, an engine failure having been recognised at this point, either a rejected take-off may be made or a take-off safely continued
take-off distance available (TODA) in the case of aeroplanes means the length of the take-off run available plus the length of the clearway, if provided
take-off distance available (TODAH) in the case of helicopters means the length of the final approach and take-off area plus, if provided, the length of helicopter clearway declared available and suitable for helicopters to complete the take-off
ake-off distance required (TODRH) in the case of helicopters means the horizontal distance required from the start of the take-off to the point at which take-off safety speed (VTOSS), a selected height and a positive climb gradient are achieved, following failure of the critical engine being recognised at the TDP, the remaining engines operating within approved operating limits
take-off flight path means the vertical and horizontal path, with the critical engine inoperative, from a specified point in the take-off for aeroplanes to 1 500 ft above the surface and for helicopters to 1 000 ft above the surface
take-off mass means the mass including everything and everyone carried at the commencement of the take-off for helicopters and take-off run for aeroplanes
take-off run available (TORA) means the length of runway that is declared available by the State of the aerodrome and suitable for the ground run of an aeroplane taking off
task specialist means a person assigned by the operator or a third party, or acting as an undertaking, who performs tasks on the ground directly associated with a specialised task or performs specialised tasks on board or from the aircraft
technical crew member means a crew member in commercial air transport HEMS, HHO or NVIS operations other than a flight or cabin crew member, assigned by the operator to duties in the aircraft or on the ground for the purpose of assisting the pilot during HEMS, HHO or NVIS operations, which may require the operation of specialised on-board equipment
technical instructions (TI) means the latest effective edition of the ‘Technical instructions for the safe transport of dangerous goods by air’, including the supplement and any addenda, approved and published by the International Civil Aviation Organisation
traffic load means the total mass of passengers, baggage, cargo and carry-on specialist equipment and including any ballast
type A EFB application means an EFB application whose malfunction or misuse has no safety effect
type B EFB application means an EFB application:
(a) whose malfunction or misuse is classified as minor failure condition or below; and
(b) which neither replaces nor duplicates any system or functionality required by airworthiness regulations, airspace requirements, or operational rules
unaided NVIS flight means, in the case of NVIS operations, that portion of a VFR flight performed at night when a crew member is not using NVG
undertaking means any natural or legal person, whether profit-making or not, or any official body whether having its own personality or not
V1 means the maximum speed in the take-off at which the pilot must take the first action to stop the aeroplane within the accelerate-stop distance. V1 also means the minimum speed in the take-off, following a failure of the critical engine at VEF, at which the pilot can continue the take-off and achieve the required height above the take-off surface within the take-off distance
VEF means the speed at which the critical engine is assumed to fail during take-off
visual approach means an approach when either part or all of an instrument approach procedure is not completed and the approach is executed with visual reference to the terrain
weather-permissible aerodrome means an adequate aerodrome where, for the anticipated time of use, weather reports, or forecasts, or any combination thereof, indicate that the weather conditions will be at or above the required aerodrome operating minima, and the runway surface condition reports indicate that a safe landing will be possible
wet lease agreement means an agreement:
— in the case of CAT operations, between air carriers pursuant to which the aircraft is operated under the AOC of the lessor; or
— in the case of commercial operations other than CAT, between operators pursuant to which the aircraft is operated under the responsibility of the lessor
wet runway means a runway whose surface is covered by any visible dampness or water up to and including 3 mm deep within the area intended to be used
existing aid means:
(i) without prejudice to Articles 144 and 172 of the Act of Accession of Austria, Finland and Sweden, to point 3 and the Appendix of Annex IV to the Act of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, to points 2 and 3(b) and the Appendix of Annex V to the Act of Accession of Bulgaria and Romania, and to points 2 and 3(b) and the Appendix of Annex IV to the Act of Accession of Croatia, all aid which existed prior to the entry into force of the TFEU in the respective Member States, that is to say, aid schemes and individual aid which were put into effect before, and are still applicable after, the entry into force of the TFEU in the respective Member States;
(ii) authorised aid, that is to say, aid schemes and individual aid which have been authorised by the Commission or by the Council;
(iii) aid which is deemed to have been authorised pursuant to Article 4(6) of Regulation (EC) No 659/1999 or to Article 4(6) of this Regulation, or prior to Regulation (EC) No 659/1999 but in accordance with this procedure;
(iv) aid which is deemed to be existing aid pursuant to Article 17 of this Regulation;
(v) aid which is deemed to be an existing aid because it can be established that at the time it was put into effect it did not constitute an aid, and subsequently became an aid due to the evolution of the internal market and without having been altered by the Member State. Where certain measures become aid following the liberalisation of an activity by Union law, such measures shall not be considered as existing aid after the date fixed for liberalisation
new aid means all aid, that is to say, aid schemes and individual aid, which is not existing aid, including alterations to existing aid
aid scheme means any act on the basis of which, without further implementing measures being required, individual aid awards may be made to undertakings defined within the act in a general and abstract manner and any act on the basis of which aid which is not linked to a specific project may be awarded to one or several undertakings for an indefinite period of time and/or for an indefinite amount
individual aid means aid that is not awarded on the basis of an aid scheme and notifiable awards of aid on the basis of an aid scheme
interested party means any Member State and any person, undertaking or association of undertakings whose interests might be affected by the granting of aid, in particular the beneficiary of the aid, competing undertakings and trade associations
unknown client means a single hypothetical client to which the institution assigns all exposures for which it has not identified the obligor, provided that Article 6(2)(a) and (b) and Article 6(3)(a) of this Regulation are not applicable
work or other subject matter means a work in the form of a book, journal, newspaper, magazine or other kind of writing, notation, including sheet music, and related illustrations, in any media, including in audio form such as audiobooks and in digital format, which is protected by copyright or related rights and which is published or otherwise lawfully made publicly available
beneficiary person means, regardless of any other disabilities, a person who:
(a) is blind;
(b) has a visual impairment which cannot be improved so as to give the person visual function substantially equivalent to that of a person who has no such impairment, and who is, as a result, unable to read printed works to substantially the same degree as a person without such an impairment;
(c) has a perceptual or reading disability and is, as a result, unable to read printed works to substantially the same degree as a person without such disability; or
(d) is otherwise unable, due to a physical disability, to hold or manipulate a book or to focus or move their eyes to the extent that would be normally acceptable for reading
accessible format copy means a copy of a work or other subject matter in an alternative manner or form that gives a beneficiary person access to the work or other subject matter, including allowing such person to have access as feasibly and comfortably as a person without any of the impairments or disabilities referred to in point 2
authorised entity means an entity that is authorised or recognised by a Member State to provide education, instructional training, adaptive reading or information access to beneficiary persons on a non-profit basis. It also includes a public institution or non-profit organisation that provides the same services to beneficiary persons as one of its primary activities, institutional obligations or as part of its public-interest missions
home Member State means either of the following:
(a) the Member State in which the registered office of the payment service provider is situated; or
(b) if the payment service provider has, under its national law, no registered office, the Member State in which its head office is situated
host Member State means the Member State other than the home Member State in which a payment service provider has an agent or a branch or provides payment services
payment institution means a legal person that has been granted authorisation in accordance with Article 11 to provide and execute payment services throughout the Union
payment transaction means an act, initiated by the payer or on his behalf or by the payee, of placing, transferring or withdrawing funds, irrespective of any underlying obligations between the payer and the payee
remote payment transaction means a payment transaction initiated via internet or through a device that can be used for distance communication
payment system means a funds transfer system with formal and standardised arrangements and common rules for the processing, clearing and/or settlement of payment transactions
payer means a natural or legal person who holds a payment account and allows a payment order from that payment account, or, where there is no payment account, a natural or legal person who gives a payment order
payee means a natural or legal person who is the intended recipient of funds which have been the subject of a payment transaction
payment service user means a natural or legal person making use of a payment service in the capacity of payer, payee, or both
payment account means an account held in the name of one or more payment service users which is used for the execution of payment transactions
payment order means an instruction by a payer or payee to its payment service provider requesting the execution of a payment transaction
payment instrument means a personalised device(s) and/or set of procedures agreed between the payment service user and the payment service provider and used in order to initiate a payment order
payment initiation service means a service to initiate a payment order at the request of the payment service user with respect to a payment account held at another payment service provider
account information service means an online service to provide consolidated information on one or more payment accounts held by the payment service user with either another payment service provider or with more than one payment service provider
account servicing payment service provider means a payment service provider providing and maintaining a payment account for a payer
consumer means a natural person who, in payment service contracts covered by this Directive, is acting for purposes other than his or her trade, business or profession
framework contract means a payment service contract which governs the future execution of individual and successive payment transactions and which may contain the obligation and conditions for setting up a payment account
money remittance means a payment service where funds are received from a payer, without any payment accounts being created in the name of the payer or the payee, for the sole purpose of transferring a corresponding amount to a payee or to another payment service provider acting on behalf of the payee, and/or where such funds are received on behalf of and made available to the payee
direct debit means a payment service for debiting a payer’s payment account, where a payment transaction is initiated by the payee on the basis of the consent given by the payer to the payee, to the payee’s payment service provider or to the payer’s own payment service provider
credit transfer means a payment service for crediting a payee’s payment account with a payment transaction or a series of payment transactions from a payer’s payment account by the payment service provider which holds the payer’s payment account, based on an instruction given by the payer
value date means a reference time used by a payment service provider for the calculation of interest on the funds debited from or credited to a payment account
reference exchange rate means the exchange rate which is used as the basis to calculate any currency exchange and which is made available by the payment service provider or comes from a publicly available source
reference interest rate means the interest rate which is used as the basis for calculating any interest to be applied and which comes from a publicly available source which can be verified by both parties to a payment service contract
authentication means a procedure which allows the payment service provider to verify the identity of a payment service user or the validity of the use of a specific payment instrument, including the use of the user’s personalised security credentials
strong customer authentication means an authentication based on the use of two or more elements categorised as knowledge (something only the user knows), possession (something only the user possesses) and inherence (something the user is) that are independent, in that the breach of one does not compromise the reliability of the others, and is designed in such a way as to protect the confidentiality of the authentication data
personalised security credentials means personalised features provided by the payment service provider to a payment service user for the purposes of authentication
sensitive payment data means data, including personalised security credentials which can be used to carry out fraud. For the activities of payment initiation service providers and account information service providers, the name of the account owner and the account number do not constitute sensitive payment data
unique identifier means a combination of letters, numbers or symbols specified to the payment service user by the payment service provider and to be provided by the payment service user to identify unambiguously another payment service user and/or the payment account of that other payment service user for a payment transaction
means of distance communication means a method which, without the simultaneous physical presence of the payment service provider and the payment service user, may be used for the conclusion of a payment services contract
durable medium means any instrument which enables the payment service user to store information addressed personally to that payment service user in a way accessible for future reference for a period of time adequate to the purposes of the information and which allows the unchanged reproduction of the information stored
business day means a day on which the relevant payment service provider of the payer or the payment service provider of the payee involved in the execution of a payment transaction is open for business as required for the execution of a payment transaction
agent means a natural or legal person who acts on behalf of a payment institution in providing payment services
branch means a place of business other than the head office which is a part of a payment institution, which has no legal personality and which carries out directly some or all of the transactions inherent in the business of a payment institution; all of the places of business set up in the same Member State by a payment institution with a head office in another Member State shall be regarded as a single branch
digital content means goods or services which are produced and supplied in digital form, the use or consumption of which is restricted to a technical device and which do not include in any way the use or consumption of physical goods or services
acquiring of payment transactions means a payment service provided by a payment service provider contracting with a payee to accept and process payment transactions, which results in a transfer of funds to the payee
issuing of payment instruments means a payment service by a payment service provider contracting to provide a payer with a payment instrument to initiate and process the payer’s payment transactions
payment brand means any material or digital name, term, sign, symbol or combination of them, capable of denoting under which payment card scheme card-based payment transactions are carried out
co-badging means the inclusion of two or more payment brands or payment applications of the same payment brand on the same payment instrument
vehicle means any motor vehicle intended for travel on land and propelled by mechanical power, but not running on rails, and any trailer, whether or not coupled
injured party means any person entitled to compensation in respect of any loss or injury caused by vehicles
national insurers’ bureau means a professional organisation which is constituted in accordance with Recommendation No 5 adopted on 25 January 1949 by the Road Transport Sub-committee of the Inland Transport Committee of the United Nations Economic Commission for Europe and which groups together insurance undertakings which, in a State, are authorised to conduct the business of motor vehicle insurance against civil liability
erritory in which the vehicle is normally based means:
(a) the territory of the State of which the vehicle bears a registration plate, irrespective of whether the plate is permanent or temporary; or
(b) in cases where no registration is required for a type of vehicle but the vehicle bears an insurance plate, or a distinguishing sign analogous to the registration plate, the territory of the State in which the insurance plate or the sign is issued; or
(c) in cases where neither a registration plate nor an insurance plate nor a distinguishing sign is required for certain types of vehicle, the territory of the State in which the person who has custody of the vehicle is permanently resident; or
(d) in cases where the vehicle does not bear any registration plate or bears a registration plate which does not correspond or no longer corresponds to the vehicle and has been involved in an accident, the territory of the State in which the accident took place, for the purpose of settling the claim as provided for in the first indent of Article 2(a) or in Article 10
green card means an international certificate of insurance issued on behalf of a national bureau in accordance with Recommendation No 5 adopted on 25 January 1949 by the Road Transport Sub-committee of the Inland Transport Committee of the United Nations Economic Commission for Europe
establishment means the head office, agency or branch of an insurance undertaking as defined in Article 2(c) of Second Council Directive 88/357/EEC of 22 June 1988 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and laying down provisions to facilitate the effective exercise of freedom to provide services
collective redundancies means dismissals effected by an employer for one or more reasons not related to the individual workers concerned where, according to the choice of the Member States, the number of redundancies is:
(i) either, over a period of 30 days:
— at least 10 in establishments normally employing more than 20 and less than 100 workers,
— at least 10 % of the number of workers in establishments normally employing at least 100 but less than 300 workers,
— at least 30 in establishments normally employing 300 workers or more,
(ii) or, over a period of 90 days, at least 20, whatever the number of workers normally employed in the establishments in question
workers’ representatives means the workers' representatives provided for by the laws or practices of the Member States
energy infrastructure means any physical equipment or facility under the energy infra-
structure categories which is located within the Contracting Parties or linking Contracting

Parties, or linking Contracting Parties and Member States;
comprehensive decision means the decision or set of decisions taken by a Contracting Party authority or authorities not including courts or tribunals, that determines whether or not a project
promoter is to be granted authorisation to build the energy infrastructure to realise a project without prejudice to any decision taken in the context of an administrative appeal procedure
project means one or several lines, pipelines, facilities, equipments or installations falling under
the energy infrastructure categories
project of Energy Community interest means a project necessary to implement the energy infrastructure and which is part of the list of projects of Energy Community interest referred to in Article 3
energy infrastructure bottleneck means limitation of physical flows in an energy system due to insufficient transmission capacity, which includes inter alia the absence of infrastructure
project promoter means one of the following:
(a) a TSO, distribution system operator or other operator or investor developing a project of Energy Community interest;
(b) where there are several TSOs, distribution system operators, other operators, investors, or any group thereof, the entity with legal personality under the applicable national law, which has been
designated by contractual arrangement between them and which has the capacity to undertake legal obligations and assume financial liability on behalf of the parties to the contractual arrangement
smart grid means an electricity network that can integrate in a cost efficient manner the behaviour and actions of all users connected to it, including generators, consumers and those that both generate and consume, in order to ensure an economically efficient and sustainable power system with low losses and high levels of quality, security of supply and safety
works means the purchase, supply and deployment of components, systems and services including software, the carrying out of development and construction and installation activities relating to a project, the acceptance of installations and the launching of a project
studies means activities needed to prepare project implementation, such as preparatory, feasibility, evaluation, testing and validation studies, including software, and any other technical support measure including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package
commissioning means the process of bringing a project into operation once it has been constructed
notification means the submission of the information required from the exporter under this Regulation to the competent authority of a Party to the Protocol or to the competent authority of a non-Party
import means the placing under a customs procedure, other than transit procedure, of GMOs introduced into the customs territory of a Party or non-Party outside the Community from a Party within the Community
exporter means any natural or legal person by whom or on whose behalf a notification is made, that is to say the person who, at the time when the notification is sent, holds the contract with the consignee in the third country and has the power to determine that the GMO is to be sent out of the customs territory of the Community. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power to determine that the GMO is to be sent out of the customs territory of the Community shall be decisive
importer means any natural or legal person, under the jurisdiction of the Party or non-Party of Import, who arranges for a GMO to be imported
transboundary movement means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party or non-Party, excluding intentional movements between Parties within the Community
the Protocol means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Convention)
biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems
competent authority means a competent authority designated by a Party to the Protocol, or the relevant equivalent body of a non-Party, which is responsible for performing the administrative functions required by the Protocol, or equivalent functions in the case of a non-Party, and is authorised to act on its behalf with respect to those functions
focal point means the entity designated by a Party to be responsible on its behalf for liaising with the Secretariat
flavourings shall mean products:
(i) not intended to be consumed as such, which are added to food in order to impart or modify odour and/or taste;
(ii) made or consisting of the following categories: flavouring substances, flavouring preparations, thermal process flavourings, smoke flavourings, flavour precursors or other flavourings or mixtures thereof
flavouring substance shall mean a defined chemical substance with flavouring properties
natural flavouring substance shall mean a flavouring substance obtained by appropriate physical, enzymatic or microbiological processes from material of vegetable, animal or microbiological origin either in the raw state or after processing for human consumption by one or more of the traditional food preparation processes listed in Annex II. Natural flavouring substances correspond to substances that are naturally present and have been identified in nature
flavouring preparation shall mean a product, other than a flavouring substance, obtained from:
(i) food by appropriate physical, enzymatic or microbiological processes either in the raw state of the material or after processing for human consumption by one or more of the traditional food preparation processes listed in Annex II;
and/or
(ii) material of vegetable, animal or microbiological origin, other than food, by appropriate physical, enzymatic or microbiological processes, the material being taken as such or prepared by one or more of the traditional food preparation processes listed in Annex II
thermal process flavouring shall mean a product obtained after heat treatment from a mixture of ingredients not necessarily having flavouring properties themselves, of which at least one contains nitrogen (amino) and another is a reducing sugar; the ingredients for the production of thermal process flavourings may be:
(i) food;
and/or
(ii) source material other than food
smoke flavouring shall mean a product obtained by fractionation and purification of a condensed smoke yielding primary smoke condensates, primary tar fractions and/or derived smoke flavourings as defined in points (1), (2) and (4) of Article 3 of Regulation (EC) No 2065/2003
flavour precursor shall mean a product, not necessarily having flavouring properties itself, intentionally added to food for the sole purpose of producing flavour by breaking down or reacting with other components during food processing; it may be obtained from:
(i) food;
and/or
(ii) source material other than food
food ingredient with flavouring properties shall mean a food ingredient other than flavourings which may be added to food for the main purpose of adding flavour to it or modifying its flavour and which contributes significantly to the presence in food of certain naturally occurring undesirable substances
source material shall mean material of vegetable, animal, microbiological or mineral origin from which flavourings or food ingredients with flavouring properties are produced; it may be:
(i) food;
or
(ii) source material other than food
appropriate physical process shall mean a physical process which does not intentionally modify the chemical nature of the components of the flavouring, without prejudice to the listing of traditional food preparation processes in Annex II, and does not involve, inter alia, the use of singlet oxygen, ozone, inorganic catalysts, metal catalysts, organometallic reagents and/or UV radiation
oversight means the verification, by or on behalf of the competent authority, on a continuous basis that the requirements of this Regulation and of the delegated and implementing acts adopted on the basis thereof, on the basis of which a certificate has been issued or in respect of which a declaration has been made, continue to be complied with
Chicago Convention means the Convention on International Civil Aviation and the Annexes thereto, signed in Chicago on 7 December 1944
ATM/ANS means air traffic management and air navigation services and covers all of the following: the air traffic management functions and services as defined in point (10) of Article 2 of Regulation (EC) No 549/2004; the air navigation services as defined in point (4) of Article 2 of that Regulation, including the network management functions and services referred to in Article 6 of Regulation (EC) No 551/2004, as well as services which augment signals emitted by satellites of core constellations of GNSS for the purpose of air navigation; flight procedures design; and services consisting in the origination and processing of data and the formatting and delivering of data to general air traffic for the purpose of air navigation
ATM/ANS constituent means tangible objects such as hardware and intangible objects such as software upon which the interoperability of the EATMN depends
ATM/ANS system means the aggregation of airborne and ground-based constituents, as well as space-based equipment, that provides support for air navigation services for all phases of flight
certification means any form of recognition in accordance with this Regulation, based on an appropriate assessment, that a legal or natural person, product, part, non-installed equipment, equipment to control unmanned aircraft remotely, aerodrome, safety-related aerodrome equipment, ATM/ANS system, ATM/ANS constituent or flight simulation training device complies with the applicable requirements of this Regulation and of the delegated and implementing acts adopted on the basis thereof, through the issuance of a certificate attesting such compliance
declaration means any written statement made in accordance with this Regulation under the sole responsibility of a legal or natural person subject to this Regulation and which confirms that the applicable requirements of this Regulation and of the delegated and implementing acts adopted on the basis thereof relating to a legal or natural person, product, part, non-installed equipment, equipment to control unmanned aircraft remotely, safety-related aerodrome equipment, ATM/ANS system, ATM/ANS constituent or flight simulation training device are complied with
qualified entity means an accredited legal or natural person which may be charged with certain certification or oversight tasks under this Regulation by and under the control and the responsibility of the Agency or a national competent authority
certificate means any certificate, approval, licence, authorisation, attestation or other document issued as the result of a certification attesting compliance with the applicable requirements
aircraft operator means any legal or natural person operating or proposing to operate one or more aircraft
aerodrome operator means any legal or natural person operating or proposing to operate one or more aerodromes
flight simulation training device means any type of device in which flight conditions are simulated on the ground, including flight simulators, flight training devices, flight and navigation procedures trainers and basic instrument training devices
aerodrome means a defined area, on land or on water, on a fixed, fixed offshore or floating structure, including any buildings, installations and equipment thereon, intended to be used either wholly or in part for the arrival, departure and surface movement of aircraft
safety-related aerodrome equipment means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is used or intended to be used to contribute to the safe operation of aircraft at an aerodrome
apron means a defined area of an aerodrome intended to accommodate aircraft for purposes of loading or unloading passengers, baggage, mail or cargo, fuelling, parking or maintenance
apron management service (AMS) means a service provided to regulate the activities and the movement of aircraft and vehicles on an apron
flight information service means a service provided for the purpose of giving advice and information useful for the safe and efficient conduct of flights
general air traffic means all movements of civil aircraft and state aircraft carried out in conformity with the procedures of the International Civil Aviation Organization (‘ICAO’)
international standards and recommended practices means the international standards and recommended practices adopted by ICAO in accordance with Article 37 of the Chicago Convention
groundhandling service means any service provided at aerodromes comprising safety -related activities in the areas of ground supervision, flight dispatch and load control, passenger handling, baggage handling, freight and mail handling, apron handling of aircraft, aircraft services, fuel and oil handling, and loading of catering; including the case where aircraft operators provide those groundhandling services to themselves (self-handling)
commercial air transport means an aircraft operation to transport passengers, cargo or mail for remuneration or other valuable consideration
safety performance means the Union's, a Member State's or an organisation's safety achievement, as defined by its safety performance targets and safety performance indicators
safety performance indicator means a parameter used for monitoring and assessing safety performance
safety performance target means a planned or intended objective for complying with safety performance indicators over a given period of time
aircraft means any machine that can derive support in the atmosphere from the reactions of the air other than reactions of the air against the earth's surface
non-installed equipment means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory carried on board of an aircraft by the aircraft operator, which is not a part, and which is used or intended to be used in operating or controlling an aircraft, supports the occupants' survivability, or which could impact the safe operation of the aircraft
unmanned aircraft means any aircraft operating or designed to operate autonomously or to be piloted remotely without a pilot on board
remote pilot means a natural person responsible for safely conducting the flight of an unmanned aircraft by operating its flight controls, either manually or, when the unmanned aircraft flies automatically, by monitoring its course and remaining able to intervene and change the course at any time
equipment to control unmanned aircraft remotely means any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is necessary for the safe operation of an unmanned aircraft, which is not a part, and which is not carried on board of that unmanned aircraft
Single European Sky airspace means airspace above the territory to which the Treaties apply, as well as any other airspace where Member States apply Regulation (EC) No 551/2004 in accordance with Article 1(3) of that Regulation
inert waste means waste that does not undergo any significant physical, chemical or biological transformations. Inert waste will not dissolve, burn or otherwise physically or chemically react, biodegrade or adversely affect other matter with which it comes into contact in a way likely to give rise to environmental pollution or harm human health. The total leachability and pollutant content of the waste and the ecotoxicity of the leachate must be insignificant, and in particular not endanger the quality of surface water and/or groundwater
unpolluted soil means soil that is removed from the upper layer of the ground during extractive activities and that is not deemed to be polluted under the national law of the Member State where the site is located or under Community law
mineral resource or mineral means a naturally occurring deposit in the earth's crust of an organic or inorganic substance, such as energy fuels, metal ores, industrial minerals and construction minerals, but excluding water
extractive industries means all establishments and undertakings engaged in surface or underground extraction of mineral resources for commercial purposes, including extraction by drilling boreholes, or treatment of the extracted material
off-shore means that area of the sea and seabed extending from the low water mark of ordinary or medium tides outwards
treatment means the mechanical, physical, biological, thermal or chemical process or combination of processes carried out on mineral resources, including from the working of quarries, with a view to extracting the mineral, including size change, classification, separation and leaching, and the re-processing of previously discarded waste, but excluding smelting, thermal manufacturing processes (other than the burning of limestone) and metallurgical processes
tailings means the waste solids or slurries that remain after the treatment of minerals by separation processes (e.g. crushing, grinding, size-sorting, flotation and other physico‐chemical techniques) to remove the valuable minerals from the less valuable rock
heap means an engineered facility for the deposit of solid waste on the surface
dam means an engineered structure designed to retain or confine water and/or waste within a pond
pond means a natural or engineered facility for disposing of fine-grained waste, normally tailings, along with varying amounts of free water, resulting from the treatment of mineral resources and from the clearing and recycling of process water
weak acid dissociable cyanide means cyanide and cyanide compounds that are dissociated with a weak acid at a defined pH
leachate means any liquid percolating through the deposited waste and emitted from or contained within a waste facility, including polluted drainage, which may adversely affect the environment if not appropriately treated
waste facility means any area designated for the accumulation or deposit of extractive waste, whether in a solid or liquid state or in solution or suspension, for the following time-periods:
— no time-period for Category A waste facilities and facilities for waste characterised as hazardous in the waste management plan;
— a period of more than six months for facilities for hazardous waste generated unexpectedly;
— a period of more than one year for facilities for non-hazardous non-inert waste;
— a period of more than three years for facilities for unpolluted soil, non-hazardous prospecting waste, waste resulting from the extraction, treatment and storage of peat and inert waste.
Such facilities are deemed to include any dam or other structure serving to contain, retain, confine or otherwise support such a facility, and also to include, but not be limited to, heaps and ponds, but excluding excavation voids into which waste is replaced, after extraction of the mineral, for rehabilitation and construction purposes
major accident means an occurrence on site in the course of an operation involving the management of extractive waste in any establishment covered by this Directive, leading to a serious danger to human health and/or the environment, whether immediately or over time, on-site or off-site
receiving body of water means surface waters, groundwater, transitional waters and coastal water as defined in Article 2(1), (2), (6) and (7) of Directive 2000/60/EC, respectively
rehabilitation means the treatment of the land affected by a waste facility in such a way as to restore the land to a satisfactory state, with particular regard to soil quality, wild life, natural habitats, freshwater systems, landscape and appropriate beneficial uses
prospecting means the search for mineral deposits of economic value, including sampling, bulk sampling, drilling and trenching, but excluding any works required for the development of such deposits, and any activities directly associated with an existing extractive operation
the public means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups
the public concerned means the public affected or likely to be affected by, or having an interest in, the environmental decision-making under Articles 6 and 7 of this Directive; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirement under national law shall be deemed to have such an interest
operator means the natural or legal person responsible for the management of extractive waste, in accordance with the national law of the Member State in which waste management takes place, including in respect of temporary storage of extractive waste as well as the operational and the after-closure phases
waste holder means the producer of the extractive waste or the natural or legal person who is in possession of it
competent person means a natural person who has the technical knowledge and experience, as defined by the national law of the Member State in which the person operates, to perform the duties arising from this Directive
competent authority means the authority or authorities which a Member State designates as responsible for performing the duties arising from this Directive
site means all land at a distinct geographic location under the management control of an operator
substantial change means a change in the structure or operation of a waste facility that, in the opinion of the competent authority, may have significant negative effects on human health or the environment
lawfully marketed in another Member State means that goods or goods of that type comply with the relevant rules applicable in that Member State or are not subject to any such rules in that Member State, and are made available to end users in that Member State
making available on the market means any supply of goods for distribution, consumption or use on the market within the territory of a Member State in the course of a commercial activity, whether in return for payment or free of charge
restricting market access means imposing conditions to be fulfilled before goods can be made available on the market in the Member State of destination, or conditions for keeping goods on that market, which in either case require the modification of one or more of the characteristics of those goods, as referred to in point (c)(i) of Article 2(2), or require the performance of additional testing
denying market access means any of the following:
(a) prohibiting goods from being made available on the market in the Member State of destination or from being kept on that market; or
(b) requiring the withdrawal or recall of those goods from that market
withdrawal means any measure aimed at preventing goods in the supply chain from being made available on the market
recall means any measure aimed at achieving the return of goods that have already been made available to the end user
prior authorisation procedure means an administrative procedure under the law of a Member State whereby the competent authority of that Member State is required, on the basis of an application by an economic operator, to give its formal approval before goods may be made available on the market in that Member State
producer means:
(a) any natural or legal person who manufactures goods or has goods designed or manufactured, or who produces goods which were not the result of a manufacturing process, including agricultural products, and markets them under that person's name or trademark,
(b) any natural or legal person who modifies goods already lawfully marketed in a Member State in a way that might affect compliance with the relevant rules applicable in that Member State, or
(c) any other natural or legal person who, by putting its name, trademark or other distinguishing feature on goods or on the documents that accompany those goods, presents itself as the producer of those goods
authorised representative means any natural or legal person established within the Union who has received a written mandate from a producer to act on that producer's behalf with regard to the making available of goods on the market in question
importer means any natural or legal person established within the Union who makes goods from a third country available on the Union market for the first time
distributor means any natural or legal person in the supply chain, other than the producer or the importer, who makes goods available on the market in a Member State
economic operator means any of the following in relation to goods: the producer, the authorised representative, the importer or the distributor
end user means any natural or legal person residing or established in the Union, to whom the goods have been made available or are being made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities
legitimate public interest grounds means any of the grounds set out in Article 36 TFEU or any other overriding reasons of public interest
light source means an electrically operated product intended to emit, or, in the case of a non-incandescent light source, intended to be possibly tuned to emit, light, or both, with all of the following optical characteristics:
(a) chromaticity coordinates x and y in the range
0,270 < x < 0,530 and
2,3172 x2 + 2,3653 x - 0,2199 < y < - 2,3172 x2 + 2,3653 x - 0,1595;
(b) a luminous flux < 500 lumen per mm2 of projected light-emitting surface area as defined in Annex I;
(c) a luminous flux between 60 and 82 000 lumen;
(d) a colour rendering index (CRI) > 0;
using incandescence, fluorescence, high-intensity discharge, inorganic light emitting diodes (LED) or organic light emitting diodes (OLED), or their combinations as lighting technology, and that can be verified as a light source according to the procedure of Annex IV.
High-pressure sodium (HPS) light sources that do not fulfil condition (a) are considered light sources for the purposes of this Regulation.
Light sources do not include:
(a) LED dies or LED chips;
(b) LED packages;
(c) products containing light source(s) from which these light source(s) can be removed for verification;
(d) light-emitting parts contained in a light source from which these parts cannot be removed for verification as a light source
control gear means one or more devices, that may or may not be physically integrated in a light source, intended to prepare the mains for the electric format required by one or more specific light sources within boundary conditions set by electric safety and electromagnetic compatibility. It may include transforming the supply and starting voltage, limiting operational and preheating current, preventing cold starting, correcting the power factor and/or reducing radio interference.
The term ‘control gear’ does not include power supplies within the scope of Commission Regulation (EC) No 278/2009. The term also does not include lighting control parts and non-lighting parts (as defined in Annex I), although such parts may be physically integrated with a control gear or marketed together as a single product.
A Power over Ethernet (PoE) switch is not a control gear in the sense of this Regulation. ‘Power-over-Ethernet switch’ or ‘PoE switch’ means equipment for power-supply and data-handling that is installed between the mains and office equipment and/or light sources for the purpose of data transfer and power supply
separate control gear means a control gear that is not physically integrated with a light source and is placed on the market as a separate product or as a part of a containing product
containing product means a product containing one or more light sources, or separate control gears, or both. Examples of containing products are luminaires that can be taken apart to allow separate verification of the contained light source(s), household appliances containing light source(s), furniture (shelves, mirrors, display cabinets) containing light source(s). If a containing product cannot be taken apart for verification of the light source and separate control gear, the entire containing product is to be considered a light source
light means electromagnetic radiation with a wavelength between 380 nm and 780 nm
mains or mains voltage (MV) means the electricity supply of 230 (± 10 %) volt of alternating current at 50 Hz
LED die or LED chip means a small block of light-emitting semiconducting material on which a functional LED circuit is fabricated
LED package means a single electric part comprising principally at least one LED die. It does not include a control gear or parts of it, a cap or active electronic components and is not connected directly to the mains voltage. It can include one or more of the following: optical elements, light converters (phosphors), thermal, mechanical and electric interfaces or parts to address electrostatic discharge concerns. Any light-emitting devices that are intended to be used directly in an LED luminaire, are considered to be light sources
chromaticity means the property of a colour stimulus defined by its chromaticity coordinates (x and y)
luminous flux or flux (Φ) expressed in lumen (lm), means the quantity derived from radiant flux (radiant power) by evaluating the electromagnetic radiation in accordance with the spectral sensitivity of the human eye. It refers to the total flux emitted by a light source in a solid angle of 4π steradians under conditions (e.g. current, voltage, temperature) specified in applicable standards. It refers to the initial flux for the undimmed light source after a short operating period, unless it is clearly specified that the flux in a dimmed condition or the flux after a given period of operation is intended. For light sources that can be tuned to emit different light spectra and/or different maximum light intensities, it refers to the flux in the ‘reference control settings’ as defined in Annex I
colour rendering index (CRI) means a metric quantifying the effect of an illuminant on the colour appearance of objects by conscious or subconscious comparison with their colour appearance under the reference illuminant and is the average Ra of the colour rendering for the first 8 test colours (R1-R8) defined in standards
incandescence means the phenomenon where light is produced from heat, in light sources typically produced through a threadlike conductor (‘filament’) which is heated by the passage of an electric current
halogen light source means an incandescent light source with a threadlike conductor made from tungsten surrounded by gas containing halogens or halogen compounds
fluorescence or fluorescent light source (FL) means the phenomenon or a light source using an electric gas discharge of the low-pressure mercury type in which most of the light is emitted by one or more layers of phosphors excited by the ultraviolet radiation from the discharge. Fluorescent light sources may have one (‘single-capped’) or two (‘double-capped’) connections (‘caps’) to their electricity supply. For the purposes of this Regulation, magnetic induction light sources are also considered as fluorescent light sources
high intensity discharge (HID) means an electric gas discharge in which the light- producing arc is stabilised by wall temperature and the arc chamber has a bulb wall loading in excess of 3 watts per square centimetre. HID light sources are limited to metal halide, high-pressure sodium and mercury vapour types, as defined in Annex I
gas discharge means a phenomenon where light is produced, directly or indirectly, by an electric discharge through a gas, plasma, metal vapour or mixture of gases and vapours
inorganic light emitting diode (LED) means a technology in which light is produced from a solid state device embodying a p-n junction of inorganic material. The junction emits optical radiation when excited by an electric current
organic light emitting diode (OLED) means a technology in which light is produced from a solid state device embodying a p-n junction of organic material. The junction emits optical radiation when excited by an electric current
high-pressure sodium light source (HPS) means a high intensity discharge light source in which the light is produced mainly by radiation from sodium vapour operating at a partial pressure of the order of 10 kilopascals. HPS light sources may have one (‘single-ended’) or two (‘double-ended’) connectors to their electricity supply
equivalent model means a model with the same technical characteristics relevant for the ecodesign requirements, but that is placed on the market or put into service by the same manufacturer or importer as another model with a different model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer's or importer's name
end-user means a natural person buying or expected to buy a product for purposes which are outside his trade, business, craft or profession
mains light source (MLS) means a light source that can be operated directly on the mains electricity supply. Light sources that operate directly on the mains, and can also operate indirectly on the mains using a separate control gear, shall be considered to be mains light sources
non-mains light source (NMLS) means a light source that requires a separate control gear to operate on the mains
directional light source (DLS) means a light source having at least 80 % of total luminous flux within a solid angle of π sr (corresponding to a cone with angle of 120°)
non-directional light source (NDLS) means a light source that is not a directional light source
connected light source (CLS) means a light source including data-connection parts that are physically or functionally inseparable from the light emitting parts to maintain the ‘reference control settings’. The light source can have physically integrated data-connection parts in a single inseparable housing, or the light source can be combined with physically separate data-connection parts placed on the market together with the light source as a single product
connected separate control gear (CSCG) means a separate control gear including data-connection parts that are physically or functionally inseparable from the actual control gear parts to maintain the ‘reference control settings’. The separate control gear can have physically integrated data-connection parts in a single inseparable housing, or the separate control gear can be combined with physically separate data-connection parts placed on the market together with the control gear as a single product
data-connection parts means parts that perform any one of the following functions:
(a) reception or transmission of wired or wireless data signals and the processing thereof (used to control the light emission function and possibly otherwise);
(b) sensing and processing of the sensed signals (used to control the light emission function and possibly otherwise);
(c) a combination of these
colour-tuneable light source (CTLS) means a light source that can be set to emit light with a large variety of colours outside the range defined in Article 2 but can also be set to emit white light inside the range defined in Article 2 for which the light source is within the scope of this Regulation.
Tuneable-white light sources that can only be set to emit light, with different correlated colour temperatures, within the range defined in Article 2, and dim-to-warm light sources that shift their white light output to lower correlated colour temperature when dimmed, simulating the behaviour of incandescent light sources, are not considered CTLS
excitation purity means a percentage computed for a CTLS set to emit light of a certain colour, using a procedure further defined in standards, by drawing a straight line on an (x and y) colour space graph from a point with colour coordinates x = 0,333 and y = 0,333 (achromatic stimulus point), going through the point representing the (x and y) colour coordinates of the light source (point (2), and ending on the outer border of the colour space (locus; point (3). The excitation purity is computed as the distance between points 1 and 2 divided by the distance between points 1 and 3. The full length of the line represents 100 % colour purity (point on the locus). The achromatic stimulus point represents 0 % colour purity (white light)
high-luminance light source’ (HLLS) means a LED light source with an average luminance greater than 30 cd/mm2 in the direction of peak intensity
luminance (in a given direction, at a given point of a real or imaginary surface) means the luminous flux transmitted by an elementary beam passing through the given point and propagating in the solid angle containing the given direction divided by the area of a section of that beam containing the given point (cd/m2)
average luminance (Luminance-HLLS) for a LED light source means the average luminance over a light-emitting area where the luminance is more than 50 % of the peak luminance (cd/mm2)
lighting control parts means parts that are integrated in a light source or in a separate control gear, or physically separated but marketed together with a light source or separate control gear as a single product, that are not strictly necessary for the light source to emit light at full-load, or for the separate control gear to supply the electric power that enables light source(s) to emit light at full-load, but that enable manual- or automatic-, direct- or remote-, control of luminous intensity, chromaticity, correlated colour temperature, light spectrum and/or beam angle. Dimmers shall also be considered as lighting control parts.
The term also includes data-connection parts, but the term does not include products within the scope of Regulation (EC) No 1275/2008
non-lighting parts means parts that are integrated in a light source, or in a separate control gear, or physically separated but marketed together with a light source or separate control gear as a single product, that are not necessary for the light source to emit light at full-load, or for the separate control gear to supply the electric power that enables light source(s) to emit light at full-load, and that are not lighting control parts. Examples include, but are not limited to: speakers (audio), cameras, repeaters for communication signals to extend the range (e.g. WiFi), parts supporting grid balance (switching to own internal batteries when necessary), battery charging, visual notification of events (mail arriving, door bell ringing, alert), use of Light Fidelity (Li-Fi, a bidirectional, high-speed and fully networked wireless communication technology).
The term also includes data-connection parts used for other functions than to control the light emission function
useful luminous flux (Φuse) means the part of the luminous flux of a light source that is considered when determining its energy efficiency:
— for non-directional light sources it is the total flux emitted in a solid angle of 4π sr (corresponding to a 360° sphere);
— for directional light sources with beam angle ≥ 90° it is the flux emitted in a solid angle of π sr (corresponding to a cone with angle of 120°);
— for directional light sources with beam angle < 90° it is the flux emitted in a solid angle of 0,586π sr (corresponding to a cone with angle of 90°)
beam angle of a directional light source means the angle between two imaginary lines in a plane through the optical beam axis, such that these lines pass through the centre of the front face of the light source and through points at which the luminous intensity is 50 % of the centre beam intensity, where the centre beam intensity is the value of luminous intensity measured on the optical beam axis. For light sources that have different beam angles in different planes, the largest beam angle shall be the one taken into account. For light sources with user-controllable beam angle, the beam angle corresponding to the ‘reference control setting’ shall be the one taken into account
full-load means:
— the condition of a light source, within the declared operating conditions, in which it emits the maximum (undimmed) luminous flux; or
— the operating conditions and loads of the control gear under efficiency measurement as specified in the relevant standards
no-load mode means the condition of a separate control gear in which its input is connected to the mains power source and its output is intentionally disconnected from light sources, and, if applicable, from lighting control parts and non-lighting parts. If these parts cannot be disconnected, they shall be switched off and their power consumption shall be minimised following the manufacturer’s instructions. No-load mode only applies to a separate control gear for which the manufacturer or importer has declared in the technical documentation that it has been designed for this mode
standby mode means the condition of a light source or of a separate control gear, where it is connected to the power supply but the light source is intentionally not emitting light, and the light source or control gear is awaiting a control signal to return to a state with light emission. Lighting control parts enabling the standby function shall be in their control mode. Non-lighting parts shall be disconnected or switched off or their power consumption shall be minimised following manufacturer’s instructions
networked standby mode means the condition of a CLS or a CSCG where it is connected to the power supply but the light source is intentionally not emitting light or the control gear does not supply the electric power that enables light source(s) to emit light, and is awaiting a remotely initiated trigger to return to a state with light emission. Lighting control parts shall be in their control mode. Non-lighting parts shall be disconnected or switched off or their power consumption shall be minimised following manufacturer’s instructions
control mode means the condition of lighting control parts where they are connected to the light source and/or to the separate control gear and performing their functions in such a way that a control signal can be internally generated or a remotely initiated trigger can be received, by wire or wireless, and processed to lead to a change in the light emission of the light source or to a corresponding desired change in the power supply by the separate control gear
remotely initiated trigger means a signal that comes from outside the light source or separate control gear via a network
control signal means an analogue or digital signal transmitted to the light source or separate control gear wirelessly or wired either via voltage modulation in separate control cables or via a modulated signal in the supply voltage. The signal transmission is not through a network but e.g. from an internal source or from a remote control delivered with the product
network means a communication infrastructure with a topology of links, an architecture, including the physical components, organisational principles, communication procedures and formats (protocols)
on-mode power (Pon) expressed in watt, means the electric power consumption of a light source in full-load with all lighting control parts and non-lighting parts disconnected. If these parts cannot be disconnected, they shall be switched off or their power consumption shall be minimised following the manufacturer’s instructions. In case of a NMLS that requires a separate control gear to operate, Pon can be measured directly on the input to the light source, or Pon is determined using a control gear with known efficiency, whose electric power consumption is subsequently subtracted from the measured mains power input value
no-load power (Pno) expressed in watt, is the electric power consumption of a separate control gear in no-load mode
standby power (Psb) expressed in watt, is the electric power consumption of a light source or of a separate control gear in standby mode
networked standby power (Pnet) expressed in watt, is the electric power consumption of a CLS or of a CSCG in networked standby mode
reference control settings (RCS) means a control setting or a combination of control settings that is used to verify compliance of a light source with this Regulation. These settings are relevant for light sources that allow the end-user to control, manually or automatically, directly or remotely, the luminous intensity, colour, correlated colour temperature, spectrum, and/or beam angle of the emitted light.
In principle, the reference control settings shall be those predefined by the manufacturer as factory default values and encountered by the user at first installation (out-of-the-box values). If the installation procedure provides for an automatic software update during first installation, or if the user has the option to perform such an update, the resulting change in settings (if any) shall be taken into account.
If the out-of-the-box value is deliberately set differently from the reference control setting (e.g. at low power for safety purposes), the manufacturer shall indicate in the technical documentation how to recall the reference control settings for compliance verification and provide a technical justification why the out-of-the-box value is set different from the reference control setting.
The light source manufacturer shall define the reference control settings such that:
— the light source is within the scope of this Regulation according to Article 1 and none of the conditions for exemption applies;
— lighting control parts and non-lighting parts are disconnected or switched-off or, in case this is not possible, the power consumption of these parts is minimal;
— the full-load condition is obtained;
— when the end-user opts to reset factory defaults, the reference control settings are obtained.
For light sources that allow the manufacturer of a containing product to make implementation choices that influence light source characteristics (e.g. definition of the operating current(s); thermal design), and that cannot be controlled by the end-user, the reference control settings need not be defined. In that case the nominal test conditions as defined by the light source manufacturer apply
high-pressure mercury light source means a high intensity discharge light source in which the major portion of light is produced, directly or indirectly, by radiation from predominantly vaporised mercury operating at a partial pressure in excess of 100 kilopascals
metal halide light source (MH) means a high intensity discharge light source in which the light is produced by radiation from a mixture of metallic vapour, metal halides and the products of the dissociation of metal halides. MH light sources may have one (‘single-ended’) or two (‘double-ended’) connectors to their electricity supply. The material for the arc tube of MH light sources can be quartz (QMH) or ceramic (CMH)
compact fluorescent light source (CFL) means a single-capped fluorescent light source with a bent-tube construction designed to fit in small spaces. CFLs may be primarily spiral-shaped (i.e. curly forms) or primarily shaped as connected multiple parallel tubes, with or without a second bulb-like envelope. CFLs are available with (CFLi) or without (CFLni) a physically integrated control gear
magnetic induction light source means a light source using fluorescent technology, where energy is transferred to the gas discharge by means of an induced high-frequency magnetic field, instead of using electrodes placed inside the gas discharge. The magnetic inductor can be external or internal to the shape of the discharge tube
QXL (Quick eXchange Lamp) means an electrical interface of a light source consisting, on the light source side, of two lateral tabs including the electrical contact surfaces and, on the opposite (rear) side, of a central protrusion allowing the light source to be grabbed with two fingers. It is specifically designed for use in a specific type of stage lighting luminaires, in which the light source is inserted from the rear of the luminaire using a one quarter turn rotation to fix or unfix it
battery-operated means a product that operates only on direct current (DC) supplied from a source contained in the same product, without being connected directly or indirectly to the mains electricity supply
second envelope means a second outer envelope on an HID light source that is not required for the production of light, such as an external sleeve for preventing mercury and glass release into the environment in case of lamp breakage. In determining the presence of a second envelope, the HID arc tubes shall not count as an envelope
non-clear envelope for an HID light source means a non-transparent outer envelope or outer tube in which the light producing arc tube is not visible
anti-glare shield means a mechanical or optical reflective or non-reflective impervious baffle designed to block direct visible radiation emitted from the light emitter in a directional light source, in order to avoid temporary partial blindness (disability glare) if viewed directly by an observer. It does not include surface coating of the light emitter in the directional light source
control gear efficiency means the output power that supplies a light source divided by the input power of a separate control gear using the conditions and methods defined in standards. Any lighting control parts and non-lighting parts are disconnected, switched off or set to minimum power consumption according to manufacturer’s instructions and subtracting this power consumption from the overall input power
functionality after endurance testing means the functionality of a LED or OLED light source after endurance testing as defined in Annex V
flicker means the perception of visual unsteadiness induced by a light stimulus, the luminance or spectral distribution of which fluctuates with time, for a static observer in a static environment. The fluctuations can be periodic and non-periodic and may be induced by the light source itself, the power source or other influencing factors
stroboscopic effect means a change in motion perception induced by a light stimulus, the luminance or spectral distribution of which fluctuates with time, for a static observer in a non-static environment. The fluctuations can be periodic and non-periodic and may be induced by the light source itself, the power source or other influencing factors
specific effective radiant ultraviolet power (mW/klm) means the effective power of the ultraviolet radiation of a light source weighted according to the spectral correction factors and related to its luminous flux
luminous intensity (candela or cd) means the quotient of the luminous flux leaving the source and propagated in the element of solid angle containing a given direction, by the element of solid angle
correlated colour temperature (CCT [K]) means the temperature of a Planckian (black body) radiator whose perceived colour most closely resembles that of a given stimulus at the same brightness and under specified viewing conditions
colour consistency means the maximum deviation of the initial (after a short period of time), spatially averaged chromaticity coordinates (x and y) of a single light source from the chromaticity centre point (cx and cy) declared by the manufacturer or the importer, expressed as the size (in steps) of the MacAdam ellipse formed around the chromaticity centre point (cx and cy)
displacement factor (cos φ1) means the cosine of the phase angle φ1 between the fundamental harmonic of the mains supply voltage and the fundamental harmonic of the mains current. It is used for mains light sources using LED- or OLED-technology. The displacement factor is measured at full-load, for the reference control settings where applicable, with any lighting control parts in control mode and non-lighting parts disconnected, switched off or set to minimum power consumption according to the manufacturer’s instructions
lumen maintenance factor (XLMF) means the ratio of the luminous flux emitted by a light source at a given time in its life to the initial luminous flux
survival factor (SF) means the defined fraction of the total number of light sources that continue to operate at a given time under defined conditions and switching frequency
lifetime for LED and OLED light sources means the time in hours between the start of their use and the moment when for 50 % of a population of light sources the light output has gradually degraded to a value below 70 % of the initial luminous flux. This is also referred to as the L70B50 lifetime
photosensitive patients means people with a specific condition causing photosensitive symptoms and who experience adverse reactions to natural and/or certain forms of artificial lighting technology
fundamental data means information related to the capacity and use of facilities for production, storage, consumption or transmission of electricity and natural gas or related to the capacity and use of LNG facilities, including planned or unplanned unavailability of these facilities
standard contract means a contract concerning a wholesale energy product admitted to trading at an organised market place, irrespective of whether or not the transaction actually takes place on that market place
non-standard contract means a contract concerning any wholesale energy product that is not a standard contract
organised market place or organised market means:
(a) a multilateral system, which brings together or facilitates the bringing together of multiple third party buying and selling interests in wholesale energy products in a way that results in a contract,
(b) any other system or facility in which multiple third-party buying and selling interests in wholesale energy products are able to interact in a way that results in a contract.
These include electricity and gas exchanges, brokers and other persons professionally arranging transactions, and trading venues as defined in Article 4 of Directive 2014/65/EU of the European Parliament and of the Council
intragroup contract is a contract on wholesale energy products entered into with a counterparty which is part of the same group provided that both counterparties are included in the same consolidation on a full basis
over-the-counter (OTC) means any transaction carried out outside an organised market
nomination means,
— for electricity: the notification of the use of cross zonal capacity by a physical transmission rights holder and its counterparty to the respective transmission system operator(s)(TSOs),
— for natural gas: the prior reporting by the network user to the TSO of the actual flow that the network user wishes to inject into or withdraw from the system
balancing energy means energy used by TSOs to perform balancing
balancing capacity (reserves) means the contracted reserve capacity
balancing services means,
— for electricity: either or both balancing capacity and balancing energy,
— for natural gas: a service provided to a TSO via a contract for gas required to meet short term fluctuations in gas demand or supply
consumption unit means a resource which receives electricity or natural gas for its own use
production unit means a facility for generation of electricity made up of a single generation unit or of an aggregation of generation units
forward capacity allocation means the attribution of long-term cross-zonal capacity through an auction before the day-ahead time frame
long-term transmission right means a physical transmission right or a FTR — option or a FTR — obligation acquired in the forward capacity allocation
allocation rules means the rules for forward capacity allocation applied by the single allocation platform
single allocation platform means the European platform established by all TSOs for forward capacity allocation
auction means the process by which long-term cross-zonal capacity is offered and allocated to market participants who submit bids
UIOSI means the principle according to which the underlying cross-zonal capacity of physical transmission rights purchased and non-nominated is automatically made available for day-ahead capacity allocation and according to which the holder of these physical transmission rights receives remuneration from the TSOs
nomination means the notification of the use of long-term cross-zonal capacity by a physical transmission rights holder and its counterparty, or an authorised third party, to the respective TSOs
nomination rules means the rules with regard to the notification of use of long-term cross-zonal capacity by a physical transmission rights holder and their counterparty, or an authorised third party, to the respective TSOs
market spread means the difference between the hourly day-ahead prices of the two concerned bidding zones for the respective market time unit in a specific direction
compensation rules means the rules according to which each TSO responsible for the bidding zone border, where long-term transmission rights have been allocated, compensates transmission right holders for curtailing the long-term transmission rights
individual grid model means a data set describing power system characteristics (generation, load and grid topology) and related rules to change these characteristics during capacity calculation, prepared by the responsible TSOs, to be merged with other individual grid model components in order to create the common grid model
common grid model means a Union-wide data set agreed between various TSOs describing the main characteristic of the power system (generation, loads and grid topology) and rules for changing these characteristics during the capacity calculation process
capacity calculation region means the geographic area in which coordinated capacity calculation is applied
scenario means the forecasted status of the power system for a given time-frame
net position means the netted sum of electricity exports and imports for each market time unit for a bidding zone
allocation constraints means the constraints to be respected during capacity allocation to maintain the transmission system within operational security limits and have not been translated into cross-zonal capacity or that are needed to increase the efficiency of capacity allocation
operational security limits means the acceptable operating boundaries for secure grid operation such as thermal limits, voltage limits, short-circuit current limits, frequency and dynamic stability limits
coordinated net transmission capacity approach means the capacity calculation method based on the principle of assessing and defining ex ante a maximum energy exchange between adjacent bidding zones
flow-based approach means a capacity calculation method in which energy exchanges between bidding zones are limited by power transfer distribution factors and available margins on critical network elements
contingency means the identified and possible or already occurred fault of an element, including not only the transmission system elements, but also significant grid users and distribution network elements if relevant for the transmission system operational security
coordinated capacity calculator means the entity or entities with the task of calculating transmission capacity, at regional level or above
generation shift key means a method of translating a net position change of a given bidding zone into estimated specific injection increases or decreases in the common grid model
remedial action means any measure applied by a TSO or several TSOs, manually or automatically, in order to maintain operational security
reliability margin means the reduction of cross-zonal capacity to cover the uncertainties within capacity calculation
market time means central European summer time or central European time, whichever is in effect
congestion income means the revenues received as a result of capacity allocation
market congestion means a situation in which the economic surplus for single day-ahead or intraday coupling has been limited by cross-zonal capacity or allocation constraints
physical congestion means any network situation where forecasted or realised power flows violate the thermal limits of the elements of the grid and voltage stability or the angle stability limits of the power system
structural congestion means congestion in the transmission system that can be unambiguously defined, is predictable, is geographically stable over time and is frequently reoccurring under normal power system conditions
matching means the trading mode through which sell orders are assigned to appropriate buy orders to ensure the maximisation of economic surplus for single day-ahead or intraday coupling
order means an intention to purchase or sell energy or capacity expressed by a market participant subject to specified execution conditions
matched orders means all buy and sell orders matched by the price coupling algorithm or the continuous trade matching algorithm
nominated electricity market operator (NEMO) means an entity designated by the competent authority to perform tasks related to single day-ahead or single intraday coupling
shared order book means a module in the continuous intraday coupling system collecting all matchable orders from the NEMOs participating in single intraday coupling and performing continuous matching of those orders
trade means one or more matched orders
single day-ahead coupling means the auctioning process where collected orders are matched and cross-zonal capacity is allocated simultaneously for different bidding zones in the day-ahead market
single intraday coupling means the continuous process where collected orders are matched and cross-zonal capacity is allocated simultaneously for different bidding zones in the intraday market
price coupling algorithm means the algorithm used in single day-ahead coupling for simultaneously matching orders and allocating cross-zonal capacities
continuous trading matching algorithm means the algorithm used in single intraday coupling for matching orders and allocating cross-zonal capacities continuously
market coupling operator (MCO) function means the task of matching orders from the day-ahead and intraday markets for different bidding zones and simultaneously allocating cross-zonal capacities
clearing price means the price determined by matching the highest accepted selling order and the lowest accepted buying order in the electricity market
scheduled exchange means an electricity transfer scheduled between geographic areas, for each market time unit and for a given direction
cheduled exchange calculator means the entity or entities with the task of calculating scheduled exchanges
day-ahead market time-frame means the time-frame of the electricity market until the day-ahead market gate closure time, where, for each market time unit, products are traded the day prior to delivery
day-ahead firmness deadline means the point in time after which cross-zonal capacity becomes firm
day-ahead market gate closure time means the point in time until which orders are accepted in the day-ahead market
intraday market time-frame means the time-frame of the electricity market after intraday cross-zonal gate opening time and before intraday cross-zonal gate closure time, where for each market time unit, products are traded prior to the delivery of the traded products
intraday cross-zonal gate opening time means the point in time when cross-zonal capacity between bidding zones is released for a given market time unit and a given bidding zone border
intraday cross-zonal gate closure time means the point in time where cross-zonal capacity allocation is no longer permitted for a given market time unit
capacity management module means a system containing up-to-date information on available cross-zonal capacity for the purpose of allocating intra-day cross-zonal capacity
non-standard intraday product means a product for continuous intraday coupling not for constant energy delivery or for a period exceeding one market time unit with specific characteristics designed to reflect system operation practices or market needs, for example orders covering multiple market time units or products reflecting production unit start-up costs
central counter party means the entity or entities with the task of entering into contracts with market participants, by novation of the contracts resulting from the matching process, and of organising the transfer of net positions resulting from capacity allocation with other central counter parties or shipping agents
shipping agent means the entity or entities with the task of transferring net positions between different central counter parties
firmness means a guarantee that cross-zonal capacity rights will remain unchanged and that a compensation is paid if they are nevertheless changed
force majeure means any unforeseeable or unusual event or situation beyond the reasonable control of a TSO, and not due to a fault of the TSO, which cannot be avoided or overcome with reasonable foresight and diligence, which cannot be solved by measures which are from a technical, financial or economic point of view reasonably possible for the TSO, which has actually happened and is objectively verifiable, and which makes it impossible for the TSO to fulfil, temporarily or permanently, its obligations in accordance with this Regulation
economic surplus for the single day-ahead or intraday coupling means the sum of (i) the supplier surplus for the single day-ahead or intraday coupling for the relevant time period, (ii) the consumer surplus for the single day-ahead or intraday coupling, (iii) the congestion income and (iv) other related costs and benefits where these increase economic efficiency for the relevant time period, supplier and consumer surplus being the difference between the accepted orders and the clearing price per energy unit multiplied by the volume of energy of the orders
alternative fuels means fuels or power sources which serve, at least partly, as a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to its decarbonisation and enhance the environmental performance of the transport sector. They include, inter alia:
— electricity,
— hydrogen,
— biofuels as defined in point (i) of Article 2 of Directive 2009/28/EC,
— synthetic and paraffinic fuels,
— natural gas, including biomethane, in gaseous form (compressed natural gas (CNG)) and liquefied form (liquefied natural gas (LNG)), and
— liquefied petroleum gas (LPG)
electric vehicle means a motor vehicle equipped with a powertrain containing at least one non-peripheral electric machine as energy converter with an electric rechargeable energy storage system, which can be recharged externall
recharging point means an interface that is capable of charging one electric vehicle at a time or exchanging a battery of one electric vehicle at a time
normal power recharging point means a recharging point that allows for a transfer of electricity to an electric vehicle with a power less than or equal to 22 kW, excluding devices with a power less than or equal to 3,7 kW, which are installed in private households or the primary purpose of which is not recharging electric vehicles, and which are not accessible to the public
high power recharging point means a recharging point that allows for a transfer of electricity to an electric vehicle with a power of more than 22 kW
shore-side electricity supply means the provision of shore-side electrical power through a standardised interface to seagoing ships or inland waterway vessels at berth
recharging or refuelling point accessible to the public means a recharging or refuelling point to supply an alternative fuel which provides Union-wide non-discriminatory access to users. Non-discriminatory access may include different terms of authentication, use and payment
refuelling point means a refuelling facility for the provision of any fuel with the exception of LNG, through a fixed or a mobile installation
refuelling point for LNG means a refuelling facility for the provision of LNG, consisting of either a fixed or mobile facility, offshore facility, or other system
fundamental data means information related to the capacity and use of facilities for production, storage, consumption or transmission of electricity and natural gas or related to the capacity and use of LNG facilities, including planned or unplanned unavailability of these facilities
standard contract means a contract concerning a wholesale energy product admitted to trading at an organised market place, irrespective of whether or not the transaction actually takes place on that market place
non-standard contract means a contract concerning any wholesale energy product that is not a standard contract
organised market place or organised market means:
(a) a multilateral system, which brings together or facilitates the bringing together of multiple third party buying and selling interests in wholesale energy products in a way that results in a contract,
(b) any other system or facility in which multiple third-party buying and selling interests in wholesale energy products are able to interact in a way that results in a contract.
These include electricity and gas exchanges, brokers and other persons professionally arranging transactions, and trading venues as defined in Article 4 of Directive 2014/65/EU of the European Parliament and of the Council
intragroup contract is a contract on wholesale energy products entered into with a counterparty which is part of the same group provided that both counterparties are included in the same consolidation on a full basis
over-the-counter (OTC) means any transaction carried out outside an organised market
nomination means,
— for electricity: the notification of the use of cross zonal capacity by a physical transmission rights holder and its counterparty to the respective transmission system operator(s)(TSOs),
— for natural gas: the prior reporting by the network user to the TSO of the actual flow that the network user wishes to inject into or withdraw from the system
balancing energy means energy used by TSOs to perform balancing
balancing capacity (reserves) means the contracted reserve capacity
balancing services means,
— for electricity: either or both balancing capacity and balancing energy,
— for natural gas: a service provided to a TSO via a contract for gas required to meet short term fluctuations in gas demand or supply
consumption unit means a resource which receives electricity or natural gas for its own use
production unit means a facility for generation of electricity made up of a single generation unit or of an aggregation of generation units
cybersecurity means the activities necessary to protect network and information systems, the users of such systems, and other persons affected by cyber threats
cyber threat means any potential circumstance, event or action that could damage, disrupt or otherwise adversely impact network and information systems, the users of such systems and other persons
European cybersecurity certification scheme means a comprehensive set of rules, technical requirements, standards and procedures that are established at Union level and that apply to the certification or conformity assessment of specific ICT products, ICT services or ICT processes
national cybersecurity certification scheme means a comprehensive set of rules, technical requirements, standards and procedures developed and adopted by a national public authority and that apply to the certification or conformity assessment of ICT products, ICT services and ICT processes falling under the scope of the specific scheme
European cybersecurity certificate means a document issued by a relevant body, attesting that a given ICT product, ICT service or ICT process has been evaluated for compliance with specific security requirements laid down in a European cybersecurity certification scheme
ICT product means an element or a group of elements of a network or information system
ICT service means a service consisting fully or mainly in the transmission, storing, retrieving or processing of information by means of network and information systems
ICT process means a set of activities performed to design, develop, deliver or maintain an ICT product or ICT service
technical specification means a document that prescribes the technical requirements to be met by, or conformity assessment procedures relating to, an ICT product, ICT service or ICT process
assurance level means a basis for confidence that an ICT product, ICT service or ICT process meets the security requirements of a specific European cybersecurity certification scheme, indicates the level at which an ICT product, ICT service or ICT process has been evaluated but as such does not measure the security of the ICT product, ICT service or ICT process concerned
conformity self-assessment means an action carried out by a manufacturer or provider of ICT products, ICT services or ICT processes, which evaluates whether those ICT products, ICT services or ICT processes meet the requirements of a specific European cybersecurity certification scheme
financial interests of the Union means all revenues, expenditures and assets covered by, acquired through, or due to the Union budget and the budgets of the institutions, bodies, offices and agencies established under the Treaties and budgets managed and monitored by them
staff of the EPPO means the personnel at the central level who supports the College, the Permanent Chambers, the European Chief Prosecutor, the European Prosecutors, the European Delegated Prosecutors and the Administrative Director in the day-to-day activities in the performance of the tasks of this Office under this Regulation
handling European Delegated Prosecutor means a European Delegated Prosecutor responsible for the investigations and prosecutions, which he/she has initiated, which have been allocated to him/her or which he/she has taken over using the right of evocation according to Article 27
assisting European Delegated Prosecutor means a European Delegated Prosecutor located in a Member State, other than the Member State of the handling European Delegated Prosecutor, where an investigation or other measure assigned to him/her is to be carried out
personal data means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person
processing means any operation or set of operations which are performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction
restriction of processing means the marking of stored personal data with the aim of limiting their processing in the future
profiling means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person’s performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements
pseudonymisation means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person
filing system means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis
controller means the EPPO or another competent authority which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union law or the law of a Member State of the European Union, the controller or the specific criteria for its nomination may be provided for by Union law or the law of a Member State of the European Union
processor means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controlle
personal data breach means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed
administrative personal data means all personal data processed by the EPPO apart from operational personal data
operational personal data means all personal data processed by the EPPO for the purposes laid down in Article 49
genetic data means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question
biometric data means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data
data concerning health means personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his/her health status
international organisation means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries
management body means an institution's body or bodies, which are appointed in accordance with national law, which are empowered to set the institution's strategy, objectives and overall direction, and which oversee and monitor management decision-making, and include the persons who effectively direct the business of the institution
management body in its supervisory function means the management body acting in its role of overseeing and monitoring management decision-making
senior management means those natural persons who exercise executive functions within an institution and who are responsible, and accountable to the management body, for the day-to-day management of the institution
systemic risk means a risk of disruption in the financial system with the potential to have serious negative consequences for the financial system and the real economy
model risk means the potential loss an institution may incur, as a consequence of decisions that could be principally based on the output of internal models, due to errors in the development, implementation or use of such models
systemically important institution means an EU parent institution, an EU parent financial holding company, an EU parent mixed financial holding company or an institution the failure or malfunction of which could lead to systemic risk
third-country group means a group of which the parent undertaking is established in a third country
gender neutral remuneration policy means a remuneration policy based on equal pay for male and female workers for equal work or work of equal value
capital conservation buffer means the own funds that an institution is required to maintain in accordance with Article 129
institution-specific countercyclical capital buffer means the own funds that an institution is required to maintain in accordance with Article 130
G-SII buffer means the own funds that are required to be maintained in accordance with Article 131(4)
O-SII buffer means the own funds that may be required to be maintained in accordance with Article 131(5)
systemic risk buffer means the own funds that an institution is or may be required to maintain in accordance with Article 133
combined buffer requirement means the total Common Equity Tier 1 capital required to meet the requirement for the capital conservation buffer extended by the following, as applicable:
(a) an institution-specific countercyclical capital buffer;
(b) a G-SII buffer;
(c) an O-SII buffer;
(d) a systemic risk buffer
countercyclical buffer rate means the rate that institutions must apply in order to calculate their institution-specific countercyclical capital buffer, and that is set in accordance with Article 136, Article 137 or by a relevant third-country authority, as the case may be
domestically authorised institution means an institution that has been authorised in the Member State for which a particular designated authority is responsible for setting the countercyclical buffer rate
buffer guide means a benchmark buffer rate calculated in accordance with Article 135(1)
worker with disabilities means any person who:
(a) is recognised as worker with disabilities under national law; or
(b) has long-term physical, mental, intellectual or sensory impairment(s) which, in interaction with various barriers, may hinder their full and effective participation in a work environment on an equal basis with other workers
disadvantaged worker means any person who:
(a) has not been in regular paid employment for the previous 6 months; or
(b) is between 15 and 24 years of age; or
(c) has not attained an upper secondary educational or vocational qualification (International Standard Classification of Education 3) or is within two years after completing full-time education and who has not previously obtained his or her first regular paid employment; or
(d) is over the age of 50 years; or
(e) lives as a single adult with one or more dependents; or
(f) works in a sector or profession in a Member State where the gender imbalance is at least 25 % higher than the average gender imbalance across all economic sectors in that Member State, and belongs to that underrepresented gender group; or
(g) is a member of an ethnic minority within a Member State and who requires development of his or her linguistic, vocational training or work experience profile to enhance prospects of gaining access to stable employment
transport means transport of passengers by aircraft, maritime transport, road, rail, or by inland waterway or freight transport services for hire or reward
transport costs means the costs of transport for hire or reward actually paid by the beneficiaries per journey, comprising:
(a) freight charges, handling costs and temporary stocking costs, in so far as these costs relate to the journey;
(b) insurance costs applied to the cargo;
(c) taxes, duties or levies applied to the cargo and, if applicable, to the deadweight, both at point of origin and point of destination; and
(d) safety and security control costs, surcharges for increased fuel costs
remote regions means outermost regions, Malta, Cyprus, Ceuta and Melilla, islands which are part of the territory of a Member State and sparsely populated areas
marketing of agricultural products means holding or display with a view to sale, offering for sale, delivery or any other manner of placing on the market, except the first sale by a primary producer to resellers or processors and any activity preparing a product for such first sale; a sale by a primary producer to final consumers shall be considered to be marketing if it takes place in separate premises reserved for that purpose
primary agricultural production means production of products of the soil and of stock farming, listed in Annex I to the Treaty, without performing any further operation changing the nature of such products
processing of agricultural products means any operation on an agricultural product resulting in a product which is also an agricultural product, except on-farm activities necessary for preparing an animal or plant product for the first sale
coal means high-grade, medium-grade and low-grade category A and B coal within the meaning of the international codification system for coal established by the United Nations Economic Commission for Europe and clarified in the Council decision of 10 December 2010 on State aid to facilitate the closure of uncompetitive coal mines
individual aid means:
(i) ad hoc aid; and
(ii) awards of aid to individual beneficiaries on the basis of an aid scheme
aid scheme means any act on the basis of which, without further implementing measures being required, individual aid awards may be made to undertakings defined within the act in a general and abstract manner and any act on the basis of which aid which is not linked to a specific project may be granted to one or several undertakings for an indefinite period of time and/or for an indefinite amount
evaluation plan means a document containing at least the following minimum elements: the objectives of the aid scheme to be evaluated, the evaluation questions, the result indicators, the envisaged methodology to conduct the evaluation, the data collection requirements, the proposed timing of the evaluation including the date of submission of the final evaluation report, the description of the independent body conducting the evaluation or the criteria that will be used for its selection and the modalities for ensuring the publicity of the evaluation
ad hoc aid means aid not granted on the basis of an aid scheme
undertaking in difficulty means an undertaking in respect of which at least one of the following circumstances occurs:
(a) In the case of a limited liability company (other than an SME that has been in existence for less than three years or, for the purposes of eligibility for risk finance aid, an SME within 7 years from its first commercial sale that qualifies for risk finance investments following due diligence by the selected financial intermediary), where more than half of its subscribed share capital has disappeared as a result of accumulated losses. This is the case when deduction of accumulated losses from reserves (and all other elements generally considered as part of the own funds of the company) leads to a negative cumulative amount that exceeds half of the subscribed share capital. For the purposes of this provision, ‘limited liability company’ refers in particular to the types of company mentioned in Annex I of Directive 2013/34/EU and ‘share capital’ includes, where relevant, any share premium.
(b) In the case of a company where at least some members have unlimited liability for the debt of the company (other than an SME that has been in existence for less than three years or, for the purposes of eligibility for risk finance aid, an SME within 7 years from its first commercial sale that qualifies for risk finance investments following due diligence by the selected financial intermediary), where more than half of its capital as shown in the company accounts has disappeared as a result of accumulated losses. For the purposes of this provision, ‘a company where at least some members have unlimited liability for the debt of the company’ refers in particular to the types of company mentioned in Annex II of Directive 2013/34/EU.
(c) Where the undertaking is subject to collective insolvency proceedings or fulfils the criteria under its domestic law for being placed in collective insolvency proceedings at the request of its creditors.
(d) Where the undertaking has received rescue aid and has not yet reimbursed the loan or terminated the guarantee, or has received restructuring aid and is still subject to a restructuring plan.
(e) In the case of an undertaking that is not an SME, where, for the past two years:
(1) the undertaking's book debt to equity ratio has been greater than 7,5 and
(2) the undertaking's EBITDA interest coverage ratio has been below 1,0
territorial spending obligations mean the obligations imposed by the authority granting the aid on beneficiaries to spend a minimum amount and/or conduct a minimum level of production activity in a particular territory
adjusted aid amount means the maximum permissible aid amount for a large investment project, calculated according to the following formula:
maximum aid amount = R × (A + 0,50 × B + 0 × C)
where: R is the maximum aid intensity applicable in the area concerned established in an approved regional map and which is in force on the date of granting the aid, excluding the increased aid intensity for SMEs; A is the initial EUR 50 million of eligible costs, B is the part of eligible costs between EUR 50 million and EUR 100 million and C is the part of eligible costs above EUR 100 million
repayable advance means a loan for a project which is paid in one or more instalments and the conditions for the reimbursement of which depend on the outcome of the project
gross grant equivalent means the amount of the aid if it had been provided in the form of a grant to the beneficiary, before any deduction of tax or other charge
start of works means the earlier of either the start of construction works relating to the investment, or the first legally binding commitment to order equipment or any other commitment that makes the investment irreversible. Buying land and preparatory works such as obtaining permits and conducting feasibility studies are not considered start of works. For take-overs, ‘start of works’ means the moment of acquiring the assets directly linked to the acquired establishment
fiscal successor scheme means a scheme in the form of tax advantages which constitutes an amended version of a previously existing scheme in the form of tax advantages and which replaces it
aid intensity means the gross aid amount expressed as a percentage of the eligible costs, before any deduction of tax or other charge
assisted areas means areas designated in an approved regional aid map approved in application of Articles2020-2021, 107(3)(a) and (c) of the Treaty for the period from 1 July 2014 to 31 December 2021 for regional aid granted until 31 December 2021 and areas designated in an approved regional aid map approved in application of Articles 107(3)(a) and (c) of the Treaty for the period from 1 January 2022 to 31 December 2027 for regional aid granted after 31 December 2021
date of granting of the aid means the date when the legal right to receive the aid is conferred on the beneficiary under the applicable national legal regime
tangible assets means assets consisting of land, buildings and plant, machinery and equipment
intangible assets means assets that do not have a physical or financial embodiment such as patents, licences, know-how or other intellectual property
wage cost means the total amount actually payable by the beneficiary of the aid in respect of the employment concerned, comprising over a defined period of time the gross wage before tax and compulsory contributions such as social security, child care and parent care costs
net increase in the number of employees means a net increase in the number of employees in the establishment concerned compared with the average over a given period in time, and that any posts lost during that period must therefore be deducted and that the number of persons employed full-time, part-time and seasonal has to be considered with their annual labour unit fractions
dedicated infrastructure means infrastructure that is built for ex-ante identifiable undertaking(s) and tailored to their needs
financial intermediary means any financial institution regardless of its form and ownership, including fund-of-funds, private equity investment funds, public investment funds, banks, micro-finance institutions and guarantee societies
journey means the movement of goods from the point of origin to the point of destination, including any intermediary sections or stages within or outside the Member State concerned, made using one or more means of transport
fair rate of return (FRR) means the expected rate of return equivalent to a risk-adjusted discount rate which reflects the level of risk of a project and the nature and level of capital the private investors plan to invest
total financing means the overall investment amount made into an eligible undertaking or project under Section 3 or under Articles 16 or 39 of this Regulation to the exclusion of entirely private investments provided on market terms and outside the scope of the relevant State aid measure
competitive bidding process means a non-discriminatory bidding process that provides for the participation of a sufficient number of undertakings and where the aid is granted on the basis of either the initial bid submitted by the bidder or a clearing price. In addition, the budget or volume related to the bidding process is a binding constraint leading to a situation where not all bidders can receive aid
operating profit means the difference between the discounted revenues and the discounted operating costs over the economic lifetime of the investment, where this difference is positive. The operating costs include costs such as personnel costs, materials, contracted services, communications, energy, maintenance, rent, administration, but exclude depreciation charges and the costs of financing if these have been covered by investment aid. Discounting revenues and operating costs using an appropriate discount rate allows a reasonable profit to be made
regional investment aid means regional aid granted for an initial investment or an initial investment in favour of a new economic activity
regional operating aid means aid to reduce an undertaking's current expenditure. This includes cost categories such as personnel costs, materials, contracted services, communications, energy, maintenance, rent, administration, but excludes depreciation charges and the costs of financing if these have been included in the eligible costs when granting investment aid
steel sector means all activities related to the production of one or more of the following products:
(a) pig iron and ferro-alloys:
pig iron for steelmaking, foundry and other pig iron, spiegeleisen and high-carbon ferro-manganese, not including other ferro-alloys;
(b) crude and semi-finished products of iron, ordinary steel or special steel:
liquid steel whether or not cast into ingots, including ingots for forging semi- finished products: blooms, billets and slabs; sheet bars and tinplate bars; hot-rolled wide coils, with the exception of production of liquid steel for castings from small and medium-sized foundries;
(c) hot finished products of iron, ordinary steel or special steel:
rails, sleepers, fishplates, soleplates, joists, heavy sections of 80 mm and over, sheet piling, bars and sections of less than 80 mm and flats of less than 150 mm, wire rod, tube rounds and squares, hot-rolled hoop and strip (including tube strip), hot-rolled sheet (coated or uncoated), plates and sheets of 3 mm thickness and over, universal plates of 150 mm and over, with the exception of wire and wire products, bright bars and iron castings;
(d) cold finished products:
tinplate, terneplate, blackplate, galvanised sheets, other coated sheets, cold-rolled sheets, electrical sheets and strip for tinplate, cold-rolled plate, in coil and in strip;
(e) tubes:
all seamless steel tubes, welded steel tubes with a diameter of over 406.4 mm
synthetic fibres sector means:
(a) extrusion/texturisation of all generic types of fibre and yarn based on polyester, polyamide, acrylic or polypropylene, irrespective of their end-uses; or
(b) polymerisation (including polycondensation) where it is integrated with extrusion in terms of the machinery used; or
(c) any ancillary process linked to the contemporaneous installation of extrusion/texturisation capacity by the prospective beneficiary or by another company in the group to which it belongs and which, in the specific business activity concerned, is normally integrated with such capacity in terms of the machinery used
transport sector means the transport of passengers by aircraft, maritime transport, road or rail and by inland waterway or freight transport services for hire or reward; more specifically, the ‘transport sector’ means the following activities in terms of NACE Rev. 2:
(a) NACE 49: Land transport and transport via pipelines, excluding NACE 49.32 Taxi operation, 49.42 Removal services, 49.5 Transport via pipeline;
(b) NACE 50: Water transport;
(c) NACE 51: Air transport, excluding NACE 51.22 Space transport
scheme targeted at a limited number of specific sectors of economic activity means a scheme which covers activities falling within the scope of less than five classes (four-digit numerical code) of the NACE Rev. 2 statistical classification
tourism activity means the following activities in terms of NACE Rev. 2:
(a) NACE 55:Accommodation;
(b) NACE 56: Food and beverage service activities;
(c) NACE 79: Travel agency, tour operator reservation service and related activities;
(d) NACE 90: Creative, arts and entertainment activities;
(e) NACE 91: Libraries, archives, museums and other cultural activities;
(f) NACE 93: Sports activities and amusement and recreation activities
sparsely populated areas means NUTS 2 regions with less than 8 inhabitants per km2 or NUTS 3 regions with less than 12,5 inhabitants per km2 or areas which are recognized by the Commission as such in an individual decision on a regional aid map in force at the time the aid is granted
very sparsely populated areas means NUTS 2 regions with less than 8 inhabitants per km2 or areas which are recognized by the Commission as such in an individual decision on a regional aid map in force at the time the aid is granted
initial investment means:
(a) an investment in tangible and intangible assets related to the setting-up of a new establishment, extension of the capacity of an existing establishment, diversification of the output of an establishment into products not previously produced in the establishment or a fundamental change in the overall production process of an existing establishment; or
(b) an acquisition of assets belonging to an establishment that has closed or would have closed had it not been purchased, and is bought by an investor unrelated to the seller and excludes sole acquisition of the shares of an undertaking
the same or a similar activity means an activity falling under the same class (four-digit numerical code) of the NACE Rev. 2 statistical classification of economic activities as laid down in Regulation (EC) No 1893/2006 of the European Parliament and of the Council of 20 December 2006 establishing the statistical classification of economic activities NACE Revision 2 and amending Council Regulation (EEC) No 3037/90 as well as certain EC Regulations on specific statistical domain
initial investment in favour of new economic activity means:
(a) an investment in tangible and intangible assets related to the setting up of a new establishment, or to the diversification of the activity of an establishment, under the condition that the new activity is not the same or a similar activity to the activity previously performed in the establishment;
(b) the acquisition of the assets belonging to an establishment that has closed or would have closed had it not been purchased, and is bought by an investor unrelated to the seller, under the condition that the new activity to be performed using the acquired assets is not the same or a similar activity to the activity performed in the establishment prior to the acquisition
large investment project means an initial investment with eligible costs exceeding EUR 50 million, calculated at prices and exchange rates on the date of granting the aid
point of destination means the place where the goods are unloaded
point of origin means the place where the goods are loaded for transport
areas eligible for operating aid means an outermost region referred to in Article 349 of the Treaty, a sparsely populated area or a very sparsely populated area
means of transport means rail transport, road freight transport, inland waterway transport, maritime transport, air transport, and intermodal transport
urban development fund (UDF) means a specialised investment vehicle set up for the purpose of investing in urban development projects under an urban development aid measure. UDFs are managed by an urban development fund manager
urban development fund manager means a professional management company with legal personality, selecting and making investments in eligible urban development projects
urban development project (UDP) means an investment project that has the potential to support the implementation of interventions envisaged by an integrated approach to sustainable urban development and contribute to achieving of the objectives defined therein, including projects with an internal rate of return which may not be sufficient to attract financing on a purely commercial basis. An urban development project may be organised as a separate block of finance within the legal structures of the beneficiary private investor or as a separate legal entity, e.g. a special purpose vehicle
integrated sustainable urban development strategy means a strategy officially proposed and certified by a relevant local authority or public sector agency, defined for a specific urban geographic area and period, that set out integrated actions to tackle the economic, environmental, climate, demographic and social challenges affecting urban areas
in-kind contribution means the contribution of land or real estate where the land or real estate forms part of the urban development project
relocation means a transfer of the same or similar activity or part thereof from an establishment in one contracting party to the EEA Agreement (initial establishment) to the establishment in which the aided investment takes place in another contracting party to the EEA Agreement (aided establishment). There is a transfer if the product or service in the initial and in the aided establishments serves at least partly the same purposes and meets the demands or needs of the same type of customers and jobs are lost in the same or similar activity in one of the initial establishments of the beneficiary in the EEA
employment directly created by an investment project means employment concerning the activity to which the investment relates, including employment created following an increase in the utilisation rate of the capacity created by the investment
organisational cooperation means the development of joint business strategies or management structures, the provision of common services or services to facilitate cooperation, coordinated activities such as research or marketing, the support of networks and clusters, the improvement of accessibility and communication, the use of joint instruments to encourage entrepreneurship and trade with SMEs
advisory services linked to cooperation means consulting, assistance and training for the exchange of knowledge and experiences and for improvement of cooperation
support services linked to cooperation means the provision of office space, websites, data banks, libraries, market research, handbooks, working and model documents
quasi-equity investment means a type of financing that ranks between equity and debt, having a higher risk than senior debt and a lower risk than common equity and whose return for the holder is predominantly based on the profits or losses of the underlying target undertaking and which are unsecured in the event of default. Quasi-equity investments can be structured as debt, unsecured and subordinated, including mezzanine debt, and in some cases convertible into equity, or as preferred equity
guarantee in the context of sections 1, 3 and 7 of the Regulation means a written commitment to assume responsibility for all or part of a third party's newly originated loan transactions such as debt or lease instruments, as well as quasi-equity instruments
guarantee rate means the percentage of loss coverage by a public investor of each and every transaction eligible under the relevant State aid measur
exit means the liquidation of holdings by a financial intermediary or investor, including trade sale, write-offs, repayment of shares/loans, sale to another financial intermediary or another investor, sale to a financial institution and sale by public offering, including an initial public offering (IPO)
financial endowment means a repayable public investment made to a financial intermediary for the purposes of making investments under a risk finance measure, and where all the proceeds shall be returned to the public investo
risk finance investment means equity and quasi-equity investments, loans including leases, guarantees, or a mix thereof to eligible undertakings for the purposes of making new investments
independent private investor means a private investor who is not a shareholder of the eligible undertaking in which it invests, including business angels and financial institutions, irrespective of their ownership, to the extent that they bear the full risk in respect of their investment. Upon the creation of a new company, private investors, including the founders, are considered to be independent from that company
equity investment means the provision of capital to an undertaking, invested directly or indirectly in return for the ownership of a corresponding share of that undertaking
first commercial sale means the first sale by a company on a product or service market, excluding limited sales to test the market
unlisted SME means an SME which is not listed on the official list of a stock exchange, except for alternative trading platforms
follow-on investment means additional risk finance investment in a company subsequent to one or more previous risk finance investment rounds
replacement capital means the purchase of existing shares in a company from an earlier investor or shareholder
entrusted entity means the European Investment Bank and the European Investment Fund, an international financial institution in which a Member State is a shareholder, or a financial institution established in a Member State aiming at the achievement of public interest under the control of a public authority, a public law body, or a private law body with a public service mission: the entrusted entity can be selected or directly appointed in accordance with the provisions of Directive 2004/18/EC on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts, or any subsequent legislation replacing that Directive in full or in part
innovative enterprise means an enterprise:
(a) that can demonstrate, by means of an evaluation carried out by an external expert that it will in the foreseeable future develop products, services or processes which are new or substantially improved compared to the state of the art in its industry, and which carry a risk of technological or industrial failure, or
(b) the research and development costs of which represent at least 10 % of its total operating costs in at least one of the three years preceding the granting of the aid or, in the case of a start-up enterprise without any financial history, in the audit of its current fiscal period, as certified by an external auditor
alternative trading platform means a multilateral trading facility as defined in Article 4(1)(15) of Directive 2004/39/EC where the majority of the financial instruments admitted to trading are issued by SMEs
loan means an agreement which obliges the lender to make available to the borrower an agreed amount of money for an agreed period of time and under which the borrower is obliged to repay the amount within the agreed period. It may take the form of a loan, or another funding instrument, including a lease, which provides the lender with a predominant component of minimum yield. The refinancing of existing loans shall not be an eligible loan
research and knowledge-dissemination organisation means an entity (such as universities or research institutes, technology transfer agencies, innovation intermediaries, research-oriented physical or virtual collaborative entities), irrespective of its legal status (organised under public or private law) or way of financing, whose primary goal is to independently conduct fundamental research, industrial research or experimental development or to widely disseminate the results of such activities by way of teaching, publication or knowledge transfer. Where such entity also pursues economic activities the financing, the costs and the revenues of those economic activities must be accounted for separately. Undertakings that can exert a decisive influence upon such an entity, in the quality of, for example, shareholders or members, may not enjoy preferential access to the results generated by it
fundamental research means experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any direct commercial application or use in view
industrial research means the planned research or critical investigation aimed at the acquisition of new knowledge and skills for developing new products, processes or services or for bringing about a significant improvement in existing products, processes or services. It comprises the creation of components parts of complex systems, and may include the construction of prototypes in a laboratory environment or in an environment with simulated interfaces to existing systems as well as of pilot lines, when necessary for the industrial research and notably for generic technology validation
experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;
Experimental development may comprise prototyping, demonstrating, piloting, testing and validation of new or improved products, processes or services in environments representative of real life operating conditions where the primary objective is to make further technical improvements on products, processes or services that are not substantially set. This may include the development of a commercially usable prototype or pilot which is necessarily the final commercial product and which is too expensive to produce for it to be used only for demonstration and validation purposes.
Experimental development does not include routine or periodic changes made to existing products, production lines, manufacturing processes, services and other operations in progress, even if those changes may represent improvements
feasibility study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success
personnel costs means the costs of researchers, technicians and other supporting staff to the extent employed on the relevant project or activity
arm’s length means that the conditions of the transaction between the contracting parties do not differ from those which would be stipulated between independent enterprises and contain no element of collusion. Any transaction that results from an open, transparent and non-discriminatory procedure is considered as meeting the arm's length principle
effective collaboration means collaboration between at least two independent parties to exchange knowledge or technology, or to achieve a common objective based on the division of labour where the parties jointly define the scope of the collaborative project, contribute to its implementation and share its risks, as well as its results. One or several parties may bear the full costs of the project and thus relieve other parties of its financial risks. Contract research and provision of research services are not considered forms of collaboration
research infrastructure means facilities, resources and related services that are used by the scientific community to conduct research in their respective fields and covers scientific equipment or sets of instruments, knowledge-based resources such as collections, archives or structured scientific information, enabling information and communication technology-based infrastructures such as grid, computing, software and communication, or any other entity of a unique nature essential to conduct research. Such infrastructures may be ‘single-sited’ or ‘distributed’ (an organised network of resources) in accordance with Article 2(a) of Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC)
innovation clusters means structures or organised groups of independent parties (such as innovative start-ups, small, medium and large enterprises, as well as research and knowledge dissemination organisations, non-for-profit organisations and other related economic actors) designed to stimulate innovative activity through promotion, sharing of facilities and exchange of knowledge and expertise and by contributing effectively to knowledge transfer, networking, information dissemination and collaboration among the undertakings and other organisations in the cluster
highly qualified personnel means staff having a tertiary education degree and at least 5 years of relevant professional experience which may also include doctoral training
innovation advisory services means consultancy, assistance and training in the fields of knowledge transfer, acquisition, protection and exploitation of intangible assets, use of standards and regulations embedding them
innovation support services means the provision of office space, data banks, libraries, market research, laboratories, quality labelling, testing and certification for the purpose of developing more effective products, processes or services
organisational innovation means the implementation of a new organisational method in an undertaking's business practices, workplace organisation or external relations, excluding changes that are based on organisational methods already in use in the undertaking, changes in management strategy, mergers and acquisitions, ceasing to use a process, simple capital replacement or extension, changes resulting purely from changes in factor prices, customisation, localisation, regular, seasonal and other cyclical changes and trading of new or significantly improved products
process innovation means the implementation of a new or significantly improved production or delivery method (including significant changes in techniques, equipment or software), excluding minor changes or improvements, increases in production or service capabilities through the addition of manufacturing or logistical systems which are very similar to those already in use, ceasing to use a process, simple capital replacement or extension, changes resulting purely from changes in factor prices, customisation, localisation, regular, seasonal and other cyclical changes and trading of new or significantly improved products
secondment means temporary employment of staff by a beneficiary with the right for the staff to return to the previous employer
severely disadvantaged worker means any person who:
(a) has not been in regular paid employment for at least 24 months; or
(b) has not been in regular paid employment for at least 12 months and belongs to one of the categories (b) to (g) mentioned under the definition of ‘disadvantaged worker’
sheltered employment means employment in an undertaking where at least 30 % of workers are workers with disabilities
environmental protection means any action designed to remedy or prevent damage to physical surroundings or natural resources by a beneficiary's own activities, to reduce risk of such damage or to lead to a more efficient use of natural resources, including energy-saving measures and the use of renewable sources of energy
Union standard means:
(a) a mandatory Union standard setting the levels to be attained in environmental terms by individual undertakings; or
(b) the obligation under Directive 2010/75/EU of the European Parliament and of the Council ( 8 ) to use the best available techniques (BAT) and ensure that emission levels of pollutants are not higher than they would be when applying BAT; for the cases where emission levels associated with the BAT have been defined in implementing acts adopted under Directive 2010/75/EU, those levels will be applicable for the purpose of this Regulation; where those levels are expressed as a range, the limit where the BAT is first achieved will be applicable
energy efficiency means an amount of saved energy determined by measuring and/or estimating consumption before and after implementation of an energy-efficiency improvement measure, whilst ensuring normalisation for external conditions that affect energy consumption
energy efficiency project means an investment project that increases the energy efficiency of a building
energy efficiency fund (EEF) means a specialised investment vehicle set up for the purpose of investing in energy efficiency projects aimed at improving the energy efficiency of buildings in both the domestic and non-domestic sectors. EEFs are managed by an energy efficiency fund manager
energy efficiency fund manager means a professional management company with a legal personality, selecting and making investments in eligible energy efficiency projects
cogeneration or combined heat and power (CHP) means the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy
energy from renewable energy sources means energy produced by plants using only renewable energy sources, as well as the share in terms of calorific value of energy produced from renewable energy sources in hybrid plants which also use conventional energy sources. It includes renewable electricity used for filling storage systems, but excludes electricity produced as a result of storage systems
renewable energy sources means the following renewable non-fossil energy sources: wind, solar, aerothermal, geothermal, hydrothermal and ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases
biofuel means liquid or gaseous fuel for transport produced from biomass
food based biofuel means a biofuel produced from cereal and other starch rich crops, sugars and oil crops as defined in the Commission's Proposal for a Directive of the European Parliament and of the Council amending Directive 98/70/EC relating to the quality of petrol and diesel fuels and amending Directive 2009/28/EC on the promotion of the use of energy from renewable sources
new and innovative technology means a new and unproven technology compared to the state of the art in the industry, which carries a risk of technological or industrial failure and is not an optimisation or scaling up of an existing technology
balancing responsibilities means responsibility for imbalances (deviations between generation, consumption and commercial transactions) of a market participant or its chosen representative, referred to as the ‘Balance Responsible Party’, within a given period of time, referred to as the ‘Imbalance Settlement Period’
standard balancing responsibilities means non-discriminatory balancing responsibilities across technologies which do not exempt any generator from those responsibilities
biomass means the biodegradable fraction of products, waste and residues from agriculture (including vegetal and animal substances), forestry and related industries including fisheries and aquaculture, as well as biogases and the biodegradable fraction of industrial and municipal waste
total levelized costs of producing energy is a calculation of the cost of generating electricity at the point of connection to a load or electricity grid. It includes the initial capital, discount rate, as well as the costs of continuous operation, fuel, and maintenance
environmental tax means a tax with a specific tax base that has a clear negative effect on the environment or which seeks to tax certain activities, goods or services so that the environmental costs may be included in their price and/or so that producers and consumers are oriented towards activities which better respect the environment
Union minimum tax level means the minimum level of taxation provided for in the Union legislation; for energy products and electricity it means the minimum level of taxation laid down in Annex I to Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity
contaminated site means a site where there is a confirmed presence, caused by man, of hazardous substances of such a level that they pose a significant risk to human health or the environment taking into account current and approved future use of the land
polluter pays principle or PPP means that the costs of measures to deal with pollution should be borne by the polluter who causes the pollution
pollution means the damage caused by a polluter directly or indirectly damaging the environment, or by creating conditions leading to such damage to physical surroundings or natural resources
energy efficient district heating and cooling means a district heating and cooling system which satisfies the definition of efficient district heating and cooling system set out in Article 2(41) and (42) of Directive 2012/27/EU. The definition includes the heating/cooling production plants and the network (including related facilities) necessary to distribute the heat/cooling from the production units to the customer premises
polluter means someone who directly or indirectly damages the environment or who creates conditions leading to such damage
re-use means any operation by which products or components that are not waste are used again for the same purpose for which they were conceived
preparing for re-use means checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing
recycling means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations
state of the art means a process in which the re-use of a waste product to manufacture an end product is economically profitable normal practice. Where appropriate, the concept of state of the art must be interpreted from a Union technological and internal market perspective
energy infrastructure means any physical equipment or facility which is located within the Union or linking the Union to one or more third countries and falling under the following categories:
(a) concerning electricity:
(i) infrastructure for transmission, as defined in Article 2(3) by Directive 2009/72/EC of 13 July 2009 concerning common rules for internal market in electricity;
(ii) infrastructure for distribution, as defined in Article 2(5) by Directive 2009/72/EC;
(iii) electricity storage, defined as facilities used for storing electricity on a permanent or temporary basis in above-ground or underground infrastructure or geological sites, provided they are directly connected to high-voltage transmission lines designed for a voltage of 110 kV or more;
(iv) any equipment or installation essential for the systems defined in points (i) to (iii) to operate safely, securely and efficiently, including protection, monitoring and control systems at all voltage levels and substations; and
(v) smart grids, defined as any equipment, line, cable or installation, both at transmission and low and medium voltage distribution level, aiming at two-way digital communication, real-time or close to real-time, interactive and intelligent monitoring and management of electricity generation, transmission, distribution and consumption within an electricity network in view of developing a network efficiently integrating the behaviour and actions of all users connected to it — generators, consumers and those that do both — in order to ensure an economically efficient, sustainable electricity system with low losses and high quality and security of supply and safety;
(b) concerning gas:
(i) transmission and distribution pipelines for the transport of natural gas and bio gas that form part of a network, excluding high-pressure pipelines used for upstream distribution of natural gas;
(ii) underground storage facilities connected to the high-pressure gas pipelines mentioned in point (i);
(iii) reception, storage and regasification or decompression facilities for liquefied natural gas (‘LNG’) or compressed natural gas (‘CNG’); and
(iv) any equipment or installation essential for the system to operate safely, securely and efficiently or to enable bi-directional capacity, including compressor stations;
(c) concerning oil:
(i) pipelines used to transport crude oil;
(ii) pumping stations and storage facilities necessary for the operation of crude oil pipelines; and
(iii) any equipment or installation essential for the system in question to operate properly, securely and efficiently, including protection, monitoring and control systems and reverse-flow devices;
(d) concerning CO2: networks of pipelines, including associated booster stations, for the transport of CO2 to storage sites, with the aim to inject the CO2 in suitable underground geological formations for permanent storage
normal residence means the place where a natural person lives for at least 185 days, in each calendar year, because of personal and occupational ties; in the case of a person whose occupational ties are in a different place from his/her personal ties and who lives in two or more Member States, the place of normal residence is regarded as the place of his/her personal ties provided that he/she returns there regularly; where a person is living in a Member State in order to carry out a task of a set duration, the place of residence is still regarded as being the place of his/her personal ties, irrespective of whether he/she returns there during the course of this activity; attendance at a university or school in another Member State does not constitute a transfer of normal residence; alternatively, ‘normal residence’ shall have the meaning attributed to it in Member States' national law
basic broadband networks means networks with basic functionalities which are based on technology platforms such as asymmetric digital subscriber lines (up to ADSL2+ networks), non-enhanced cable (e.g. DOCSIS 2.0), mobile networks of third generation (UMTS) and satellite systems
broadband-related civil engineering works means the civil engineering works which are necessary for the deployment of a broadband network, such as digging up a road in order to enable the placement of (broadband) ducts
ducts means underground pipes or conduits used to house (fibre, copper or coax) cables of a broadband network
physical unbundling grants access to the end-consumer access line and allows competitors' own transmission systems to directly transmit over it
passive broadband infrastructure means a broadband network without any active component. It typically comprises civil engineering infrastructure, ducts and dark fibre and street cabinets
next generation access (NGA) networks means advanced networks which have at least the following characteristics: (a) deliver services reliably at a very high speed per subscriber through optical (or equivalent technology) backhaul sufficiently close to user premises to guarantee the actual delivery of the very high speed; (b) support a variety of advanced digital services including converged all-IP services, and (c) have substantially higher upload speeds (compared to basic broadband networks). At the current stage of market and technological development, NGA networks are: (a) fibre-based access networks (FTTx), (b) advanced upgraded cable networks and (c) certain advanced wireless access networks capable of delivering reliable high-speeds per subscriber
wholesale access means access which enables an operator to utilise the facilities of another operator. The widest possible access to be provided over the relevant network shall include, on the basis of the current technological developments, at least the following access products. For FTTH/FTTB networks: ducts access, access to dark fibre, unbundled access to the local loop, and bitstream access. For cable networks: duct access and bit-stream access. For FTTC networks: duct access, sub-loop unbundling and bit-stream access. For passive network infrastructure: duct access, access to dark fibre and/or unbundled access to the local loop. For ADSL-based broadband networks: unbundled access to the local loop, bit-stream access. For mobile or wireless networks: bit-stream, sharing of physical masts and access to the backhaul networks. For satellite platforms: bit-stream access
difficult audiovisual works means the works identified as such by Member States on the basis of pre-defined criteria when setting up schemes or granting the aid and may include films whose sole original version is in a language of a Member State with a limited territory, population or language area, short films, films by first-time and second-time directors, documentaries, or low budget or otherwise commercially difficult works
reasonable profit shall be determined with respect to the typical profit for the sector concerned. In any event, a rate of return on capital that does not exceed the relevant swap rate plus a premium of 100 basis points will be considered to be reasonable
professional sport means the practice of sport in the nature of gainful employment or remunerated service, irrespective of whether or not a formal labour contract has been established between the professional sportsperson and the relevant sport organisation, where the compensation exceeds the cost of participation and constitutes a significant part of the income for the sportsperson. Travel and accommodation expenses to participate to the sport event shall not be considered as compensation for the purposes of this Regulation
airport infrastructure means infrastructure and equipment for the provision of airport services by the airport to airlines and the various service providers, including runways, terminals, aprons, taxiways, centralised ground handling infrastructure and any other facilities that directly support the airport services, excluding infrastructure and equipment which is primarily necessary for pursuing non-aeronautical activities
airline means any airline with a valid operating licence issued by a Member State or a Member of the Common European Aviation Area pursuant to Regulation (EC) No 1008/2008 of the European Parliament and of the Council
airport means an entity or group of entities performing the economic activity of providing airport services to airlines
airport services means services provided to airlines by an airport or any of its subsidiaries, to ensure the handling of aircraft, from landing to take-off, and of passengers and freight, so as to enable airlines to provide air transport services, including the provision of ground handling services and the provision of centralised ground handling infrastructure
average annual passenger traffic means a figure determined on the basis of the inbound and outbound passenger traffic during the two financial years preceding that in which the aid is granted
centralised ground handling infrastructure means infrastructure which is normally operated by the airport manager and put at the disposal of the various providers of ground handling services active at the airport in exchange for remuneration, excluding equipment owned or operated by the providers of ground handling services
high-speed train means a train capable of reaching speeds of over 200 km/h
non-aeronautical activities means commercial services to airlines or other users of the airport, including ancillary services to passengers, freight forwarders or other service providers, renting out of offices and shops, car parking and hotels
regional airport means an airport with average annual passenger traffic of up to 3 million passengers
port means an area of land and water made up of such infrastructure and equipment, so as to permit the reception of waterborne vessels, their loading and unloading, the storage of goods, the receipt and delivery of those goods and the embarkation and disembarkation of passengers, crew and other persons and any other infrastructure necessary for transport operators in the port
maritime port means a port for, principally, the reception of sea-going vessels
inland port means a port other than a maritime port, for the reception of inland waterway vessels
port infrastructure means infrastructure and facilities for the provision of transport related port services, for example berths used for the mooring of ships, quay walls, jetties and floating pontoon ramps in tidal areas, internal basins, backfills and land reclamation, alternative fuel infrastructure and infrastructure for the collection of ship-generated waste and cargo residues
port superstructure means surface arrangements (such as for storage), fixed equipment (such as warehouses and terminal buildings) as well as mobile equipment (such as cranes) located in a port for the provision of transport related port services
access infrastructure means any type of infrastructure necessary to ensure access and entry from land or sea and river by users to a port, or in a port, such as roads, rail tracks, channels and locks
dredging means the removal of sediments from the bottom of the waterway access to a port, or in a port
alternative fuel infrastructure means a fixed, mobile or offshore port infrastructure allowing a port to supply vessels with energy sources such as electricity, hydrogen, biofuels as defined in point (i) of Article 2 of Directive 2009/28/EC, synthetic and paraffinic fuels, natural gas, including biomethane, in gaseous form (compressed natural gas (CNG)) and liquefied form (liquefied natural gas (LNG)), and liquefied petroleum gas (LPG) which serve, at least partly, as a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to its decarbonisation and enhance the environmental performance of the transport sector
vessels mean floating structures, whether self-propelled or not, with one or more surface displacement hulls
sea-going vessels mean vessels other than those which navigate solely or mainly in inland waterways or in waters within, or closely adjacent to, sheltered waters
inland waterway vessels mean vessels intended solely or mainly for navigation on inland waterways or in waters within, or closely adjacent to, sheltered waters
infrastructure for the collection of ship-generated waste and cargo residues means fixed, floating or mobile port facilities capable of receiving ship-generated waste or cargo residues as defined in Directive 2000/59/EC of the European Parliament and of the Council
office means the central industrial property office of the Member State or the Benelux Office for Intellectual Property, entrusted with the registration of trade marks
register means the register of trade marks kept by an office
guarantee or certification mark means a trade mark which is described as such when the mark is applied for and is capable of distinguishing goods or services which are certified by the proprietor of the mark in respect of material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics, from goods and services which are not so certified
collective mark means a trade mark which is described as such when the mark is applied for and is capable of distinguishing the goods or services of the members of an association which is the proprietor of the mark from the goods or services of other undertakings
carrier means any natural or legal person whose occupation it is to provide passenger transport by air
external borders means the external borders of the Member States with third countries
border control means a check carried out at a border in response exclusively to an intention to cross that border, regardless of any other consideration
border crossing point means any crossing point authorised by the competent authorities for crossing external borders
air carrier means an air transport undertaking with a valid operating licence or equivalent permitting it to carry out carriage of passengers by air
extra-EU flight means any scheduled or non-scheduled flight by an air carrier flying from a third country and planned to land on the territory of a Member State or flying from the territory of a Member State and planned to land in a third country, including in both cases flights with any stop-overs in the territory of Member States or third countries
intra-EU flight means any scheduled or non-scheduled flight by an air carrier flying from the territory of a Member State and planned to land on the territory of one or more of the other Member States, without any stop-overs in the territory of a third country
passenger means any person, including persons in transfer or transit and excluding members of the crew, carried or to be carried in an aircraft with the consent of the air carrier, such consent being manifested by that person's registration in the passengers list
passenger name record or PNR means a record of each passenger's travel requirements which contains information necessary to enable reservations to be processed and controlled by the booking and participating air carriers for each journey booked by or on behalf of any person, whether it is contained in reservation systems, departure control systems used to check passengers onto flights, or equivalent systems providing the same functionalities
reservation system means the air carrier's internal system, in which PNR data are collected for the handling of reservations
push method means the method whereby air carriers transfer PNR data listed in Annex I into the database of the authority requesting them
serious crime means the offences listed in Annex II that are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a Member State
to depersonalise through masking out of data elements means to render those data elements which could serve to identify directly the data subject invisible to a user
motor vehicle shall mean any power-driven vehicle which travels on the road by its own means
trailer shall mean any vehicle intended to be coupled to a motor vehicle excluding semi-trailers, and constructed and equipped for the carriage of goods
semi-trailer shall mean any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle with a substantial part of its weight and of the weight of its load being borne by the motor vehicle, and constructed and equipped for the carriage of goods
vehicle combination shall mean either:
— a road train consisting of a motor vehicle coupled to a trailer; or
— an articulated vehicle consisting of a motor vehicle coupled to a semi-trailer
conditoned vehicle shall mean any vehicle whose fixed or movable superstructures are specially equipped for the carriage of goods at controlled temperatures and whose side walls, inclusive of insulation, are each at least 45 mm thick
bus shall mean a vehicle with more than nine seats including the driver's seat, constructed and equipped to carry passengers and their luggage. It may have one or two decks and may also draw a luggage trailer
articulated bus shall mean a bus consisting of two rigid sections connected to each other by an articulated section. On this type of vehicle the passenger compartments in each of the two rigid sections shall be intercommunicating. The articulated section shall permit the free movement of travellers between the rigid sections. Connection and disconnection of the two sections shall be possible only in a workshop
maximum authorized dimensions shall mean the maximum dimensions for use of a vehicle, as laid down in Annex I to this Directive
maximum authorized weight shall mean the maximum weight for use of a laden vehicle in international traffic
maximum authorized axle weight shall mean the maximum weight for use in international traffic of a laden axle or group of axles
indivisible load shall mean a load that cannot, for the purpose of carriage by road, be divided into two or more loads without undue expense or risk of damage and which owing to its dimensions or mass cannot be carried by a motor vehicle, trailer, road train or articulated vehicle complying with this Directive in all respects
tonne shall mean the weight executed by the mass of a tonne and shall correspond to 9,8 kilonewtons (kN)
alternative fuels shall mean fuels or power sources which serve, at least partly, as a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to its decarbonisation and enhance the environmental performance of the transport sector, consisting of:
(a) electricity consumed in all types of electric vehicles;
(b) hydrogen;
(c) natural gas, including biomethane, in gaseous form (Compressed Natural Gas — CNG) and liquefied form (Liquefied Natural Gas — LNG);
(d) Liquefied Petroleum Gas (LPG);
(e) mechanical energy from on-board storage/on-board sources, including waste heat
alternatively fuelled vehicle shall mean a motor vehicle powered wholly or in part by an alternative fuel and which has been approved under the framework of Directive 2007/46/EC
zero-emission vehicle shall mean a zero-emission heavy-duty vehicle as defined in point (11) of Article 3 of Regulation (EU) 2019/1242 of the European Parliament and of the Council
intermodal transport operation shall mean:
(a) the combined transport operations defined in Article 1 of Council Directive 92/106/EEC ( 3 ) engaged in the transport of one or more containers or swap bodies, up to a total maximum length of 45 feet; or
(b) transport operations engaged in the transport of one or more containers or swap bodies, up to a total maximum length of 45 feet, using waterborne transport, provided that the length of the initial or the final road leg does not exceed 150 km in the territory of the Union. The distance of 150 km referred to above may be exceeded in order to reach the nearest suitable transport terminal for the envisaged service in the case of:
(i) vehicles complying with point 2.2.2(a) or (b) of Annex I; or
(ii) vehicles complying with point 2.2.2(c) or (d) of Annex I, in cases where such distances are permitted in the relevant Member State.
For intermodal transport operations, the nearest suitable transport terminal providing a service may be located in a Member State other than the Member State in which the shipment was loaded or unloaded
shipper shall mean a legal entity or a natural or legal person who is named on the bill of lading or on an equivalent transport document, such as a ‘through’ bill of lading, as the shipper and/or in whose name or on whose behalf a contract of carriage has been concluded with the transport company
carriage by road means any journey made entirely or in part on roads open to the public by a vehicle, whether laden or not, used for the carriage of passengers or goods
vehicle means a motor vehicle, tractor, trailer or semi-trailer or a combination of these vehicles, defined as follows:
— ‘motor vehicle’: any self-propelled vehicle travelling on the road, other than a vehicle permanently running on rails, and normally used for carrying passengers or goods,
— ‘tractor’: any self-propelled vehicle travelling on the road, other than a vehicle permanently running on rails, and specially designed to pull, push or move trailers, semi-trailers, implements or machines,
— ‘trailer’: any vehicle designed to be coupled to a motor vehicle or tractor,
— ‘semi-trailer’: a trailer without a front axle coupled in such a way that a substantial part of its weight and of the weight of its load is borne by the tractor or motor vehicle
driver means any person who drives the vehicle even for a short period, or who is carried in a vehicle as part of his duties to be available for driving if necessary
break means any period during which a driver may not carry out any driving or any other work and which is used exclusively for recuperation
other work means all activities which are defined as working time in Article 3(a) of Directive 2002/15/EC except ‘driving’, including any work for the same or another employer, within or outside of the transport sector
rest means any uninterrupted period during which a driver may freely dispose of his time
daily rest period means the daily period during which a driver may freely dispose of his time and covers a ‘regular daily rest period’ and a ‘reduced daily rest period’:
— ‘regular daily rest period’ means any period of rest of at least 11 hours. Alternatively, this regular daily rest period may be taken in two periods, the first of which must be an uninterrupted period of at least 3 hours and the second an uninterrupted period of at least nine hours,
— ‘reduced daily rest period’ means any period of rest of at least nine hours but less than 11 hours
weekly rest period means the weekly period during which a driver may freely dispose of his time and covers a ‘regular weekly rest period’ and a ‘reduced weekly rest period’:
— ‘regular weekly rest period’ means any period of rest of at least 45 hours,
— ‘reduced weekly rest period’ means any period of rest of less than 45 hours, which may, subject to the conditions laid down in Article 8(6), be shortened to a minimum of 24 consecutive hours
a week means the period of time between 00.00 on Monday and 24.00 on Sunday
driving time means the duration of driving activity recorded:
— automatically or semi-automatically by the recording equipment as defined in Annex I and Annex IB of Regulation (EEC) No 3821/85, or
— manually as required by Article 16(2) of Regulation (EEC) No 3821/85
daily driving time means the total accumulated driving time between the end of one daily rest period and the beginning of the following daily rest period or between a daily rest period and a weekly rest period
weekly driving time means the total accumulated driving time during a week
maximum permissible mass means the maximum authorised operating mass of a vehicle when fully laden
multi-manning means the situation where, during each period of driving between any two consecutive daily rest periods, or between a daily rest period and a weekly rest period, there are at least two drivers in the vehicle to do the driving. For the first hour of multi-manning the presence of another driver or drivers is optional but for the remainder of the period it is compulsory
transport undertaking means any natural person, any legal person, any association or group of persons without legal personality, whether profit-making or not, or any official body, whether having its own legal personality or being dependent upon an authority having such a personality, which engages in carriage by road, whether for hire or reward or for own account
driving period means the accumulated driving time from when a driver commences driving following a rest period or a break until he takes a rest period or a break. The driving period may be continuous or broken
non-commercial carriage means any carriage by road, other than carriage for hire or reward or on own account, for which no direct or indirect remuneration is received and which does not directly or indirectly generate any income for the driver of the vehicle or for others, and which is not linked to professional or commercial activity
investment firm means any legal person whose regular occupation or business is the provision of one or more investment services to third parties and/or the performance of one or more investment activities on a professional basis.
Member States may include in the definition of investment firms undertakings which are not legal persons, provided that:
(a) their legal status ensures a level of protection for third parties’ interests equivalent to that afforded by legal persons; and
(b) they are subject to equivalent prudential supervision appropriate to their legal form.
However, where a natural person provides services involving the holding of third party funds or transferable securities, that person may be considered to be an investment firm for the purposes of this Directive and of Regulation (EU) No 600/2014 only if, without prejudice to the other requirements imposed in this Directive, in Regulation (EU) No 600/2014, and in Directive 2013/36/EU, that person complies with the following conditions:
(a) the ownership rights of third parties in instruments and funds must be safeguarded, especially in the event of the insolvency of the firm or of its proprietors, seizure, set-off or any other action by creditors of the firm or of its proprietors;
(b) the firm must be subject to rules designed to monitor the firm’s solvency and that of its proprietors;
(c) the firm’s annual accounts must be audited by one or more persons empowered, under national law, to audit accounts;
(d) where the firm has only one proprietor, that person must make provision for the protection of investors in the event of the firm’s cessation of business following the proprietor’s death or incapacity or any other such event
investment services and activities means any of the services and activities listed in Section A of Annex I relating to any of the instruments listed in Section C of Annex I.
The Commission shall adopt delegated acts in accordance with Article 89 measures specifying:
(a) the derivative contracts referred to in Section C.6 of Annex I that have the characteristics of wholesale energy products that must be physically settled and C.6 energy derivative contracts;
(b) the derivative contracts referred to in Section C.7 of Annex I that have the characteristics of other derivative financial instruments;
(c) the derivative contracts referred to in Section C.10 of Annex I that have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are traded on a regulated market, an MTF or an OTF
investment advice means the provision of personal recommendations to a client, either upon its request or at the initiative of the investment firm, in respect of one or more transactions relating to financial instruments
execution of orders on behalf of clients means acting to conclude agreements to buy or sell one or more financial instruments on behalf of clients and includes the conclusion of agreements to sell financial instruments issued by an investment firm or a credit institution at the moment of their issuance
dealing on own account means trading against proprietary capital resulting in the conclusion of transactions in one or more financial instruments
market maker means a person who holds himself out on the financial markets on a continuous basis as being willing to deal on own account by buying and selling financial instruments against that person’s proprietary capital at prices defined by that person
portfolio management means managing portfolios in accordance with mandates given by clients on a discretionary client-by-client basis where such portfolios include one or more financial instruments
client means any natural or legal person to whom an investment firm provides investment or ancillary services
professional client means a client meeting the criteria laid down in Annex II
retail client means a client who is not a professional client
SME growth market means a MTF that is registered as an SME growth market in accordance with Article 33
small and medium-sized enterprises for the purposes of this Directive, means companies that had an average market capitalisation of less than EUR 200 000 000 on the basis of end-year quotes for the previous three calendar years
limit order means an order to buy or sell a financial instrument at its specified price limit or better and for a specified size
C6 energy derivative contracts means options, futures, swaps, and any other derivative contracts mentioned in Section C.6 of Annex I relating to coal or oil that are traded on an OTF and must be physically settled
money-market instruments means those classes of instruments which are normally dealt in on the money market, such as treasury bills, certificates of deposit and commercial papers and excluding instruments of payment
market operator means a person or persons who manages and/or operates the business of a regulated market and may be the regulated market itself
multilateral system means any system or facility in which multiple third-party buying and selling trading interests in financial instruments are able to interact in the system
systematic internaliser means an investment firm which, on an organised, frequent systematic and substantial basis, deals on own account when executing client orders outside a regulated market, an MTF or an OTF without operating a multilateral system;
The frequent and systematic basis shall be measured by the number of OTC trades in the financial instrument carried out by the investment firm on own account when executing client orders. The substantial basis shall be measured either by the size of the OTC trading carried out by the investment firm in relation to the total trading of the investment firm in a specific financial instrument or by the size of the OTC trading carried out by the investment firm in relation to the total trading in the Union in a specific financial instrument. The definition of a systematic internaliser shall apply only where the pre-set limits for a frequent and systematic basis and for a substantial basis are both crossed or where an investment firm chooses to opt-in under the systematic internaliser regime
regulated market means a multilateral system operated and/or managed by a market operator, which brings together or facilitates the bringing together of multiple third-party buying and selling interests in financial instruments – in the system and in accordance with its non-discretionary rules – in a way that results in a contract, in respect of the financial instruments admitted to trading under its rules and/or systems, and which is authorised and functions regularly and in accordance with Title III of this Directive
multilateral trading facility or MTF means a multilateral system, operated by an investment firm or a market operator, which brings together multiple third-party buying and selling interests in financial instruments – in the system and in accordance with non-discretionary rules – in a way that results in a contract in accordance with Title II of this Directive
organised trading facility or OTF means a multilateral system which is not a regulated market or an MTF and in which multiple third-party buying and selling interests in bonds, structured finance products, emission allowances or derivatives are able to interact in the system in a way that results in a contract in accordance with Title II of this Directive
trading venue means a regulated market, an MTF or an OTF
liquid market means a market for a financial instrument or a class of financial instruments, where there are ready and willing buyers and sellers on a continuous basis, assessed in accordance with the following criteria, taking into consideration the specific market structures of the particular financial instrument or of the particular class of financial instruments:
(a) the average frequency and size of transactions over a range of market conditions, having regard to the nature and life cycle of products within the class of financial instrument;
(b) the number and type of market participants, including the ratio of market participants to traded instruments in a particular product;
(c) the average size of spreads, where available
competent authority means the authority, designated by each Member State in accordance with Article 67, unless otherwise specified in this Directive
tied agent means a natural or legal person who, under the full and unconditional responsibility of only one investment firm on whose behalf it acts, promotes investment and/or ancillary services to clients or prospective clients, receives and transmits instructions or orders from the client in respect of investment services or financial instruments, places financial instruments or provides advice to clients or prospective clients in respect of those financial instruments or services
branch means a place of business other than the head office which is a part of an investment firm, which has no legal personality and which provides investment services and/or activities and which may also perform ancillary services for which the investment firm has been authorised; all the places of business set up in the same Member State by an investment firm with headquarters in another Member State shall be regarded as a single branch
qualifying holding means a direct or indirect holding in an investment firm which represents 10 % or more of the capital or of the voting rights, as set out in Articles 9 and 10 of Directive 2004/109/EC of the European Parliament and of the Council, taking into account the conditions regarding aggregation thereof laid down in Article 12(4) and (5) of that Directive, or which makes it possible to exercise a significant influence over the management of the investment firm in which that holding subsists
close links means a situation in which two or more natural or legal persons are linked by:
(a) participation in the form of ownership, direct or by way of control, of 20 % or more of the voting rights or capital of an undertaking;
(b) ‘control’ which means the relationship between a parent undertaking and a subsidiary, in all the cases referred to in Article 22(1) and (2) of Directive 2013/34/EU, or a similar relationship between any natural or legal person and an undertaking, any subsidiary undertaking of a subsidiary undertaking also being considered to be a subsidiary of the parent undertaking which is at the head of those undertakings;
(c) a permanent link of both or all of them to the same person by a control relationship
management body means the body or bodies of an investment firm, market operator or data reporting services provider, which are appointed in accordance with national law, which are empowered to set the entity’s strategy, objectives and overall direction, and which oversee and monitor management decision-making and include persons who effectively direct the business of the entity.
Where this Directive refers to the management body and, pursuant to national law, the managerial and supervisory functions of the management body are assigned to different bodies or different members within one body, the Member State shall identify the bodies or members of the management body responsible in accordance with its national law, unless otherwise specified by this Directive
senior management means natural persons who exercise executive functions within an investment firm, a market operator or a data reporting services provider and who are responsible, and accountable to the management body, for the day-to-day management of the entity, including for the implementation of the policies concerning the distribution of services and products to clients by the firm and its personnel
matched principal trading means a transaction where the facilitator interposes itself between the buyer and the seller to the transaction in such a way that it is never exposed to market risk throughout the execution of the transaction, with both sides executed simultaneously, and where the transaction is concluded at a price where the facilitator makes no profit or loss, other than a previously disclosed commission, fee or charge for the transaction
algorithmic trading means trading in financial instruments where a computer algorithm automatically determines individual parameters of orders such as whether to initiate the order, the timing, price or quantity of the order or how to manage the order after its submission, with limited or no human intervention, and does not include any system that is only used for the purpose of routing orders to one or more trading venues or for the processing of orders involving no determination of any trading parameters or for the confirmation of orders or the post-trade processing of executed transactions
high-frequency algorithmic trading technique means an algorithmic trading technique characterised by:
(a) infrastructure intended to minimise network and other types of latencies, including at least one of the following facilities for algorithmic order entry: co-location, proximity hosting or high-speed direct electronic access;
(b) system-determination of order initiation, generation, routing or execution without human intervention for individual trades or orders; and
(c) high message intraday rates which constitute orders, quotes or cancellations
direct electronic access means an arrangement where a member or participant or client of a trading venue permits a person to use its trading code so the person can electronically transmit orders relating to a financial instrument directly to the trading venue and includes arrangements which involve the use by a person of the infrastructure of the member or participant or client, or any connecting system provided by the member or participant or client, to transmit the orders (direct market access) and arrangements where such an infrastructure is not used by a person (sponsored access)
cross-selling practice means the offering of an investment service together with another service or product as part of a package or as a condition for the same agreement or package
structured deposit means a deposit as defined in point (3) of Article 2(1) of Directive 2014/49/EU of the European Parliament and of the Council, which is fully repayable at maturity on terms under which interest or a premium will be paid or is at risk, according to a formula involving factors such as:
(a) an index or combination of indices, excluding variable rate deposits whose return is directly linked to an interest rate index such as Euribor or Libor;
(b) a financial instrument or combination of financial instruments;
(c) a commodity or combination of commodities or other physical or non-physical non-fungible assets; or
(d) a foreign exchange rate or combination of foreign exchange rates
transferable securities means those classes of securities which are negotiable on the capital market, with the exception of instruments of payment, such as:
(a) shares in companies and other securities equivalent to shares in companies, partnerships or other entities, and depositary receipts in respect of shares;
(b) bonds or other forms of securitised debt, including depositary receipts in respect of such securities;
(c) any other securities giving the right to acquire or sell any such transferable securities or giving rise to a cash settlement determined by reference to transferable securities, currencies, interest rates or yields, commodities or other indices or measures
depositary receipts means those securities which are negotiable on the capital market and which represent ownership of the securities of a non-domiciled issuer while being able to be admitted to trading on a regulated market and traded independently of the securities of the non-domiciled issuer
exchange-traded fund means a fund of which at least one unit or share class is traded throughout the day on at least one trading venue and with at least one market maker which takes action to ensure that the price of its units or shares on the trading venue does not vary significantly from its net asset value and, where applicable, from its indicative net asset value
consolidated tape provider or CTP means a person authorised under this Directive to provide the service of collecting trade reports for financial instruments listed in Articles 6, 7, 10, 12 and 13, 20 and 21 of Regulation (EU) No 600/2014 from regulated markets, MTFs, OTFs and APAs and consolidating them into a continuous electronic live data stream providing price and volume data per financial instrument
approved reporting mechanism or ARM means a person authorised under this Directive to provide the service of reporting details of transactions to competent authorities or to ESMA on behalf of investment firms
home Member State means:
(a) in the case of investment firms:
(i) if the investment firm is a natural person, the Member State in which its head office is situated;
(ii) if the investment firm is a legal person, the Member State in which its registered office is situated;
(iii) if the investment firm has, under its national law, no registered office, the Member State in which its head office is situated;
(b) in the case of a regulated market, the Member State in which the regulated market is registered or, if under the law of that Member State it has no registered office, the Member State in which the head office of the regulated market is situated;
(c) in the case of an APA, a CTP or an ARM:
(i) if the APA, CTP or ARM is a natural person, the Member State in which its head office is situated;
(ii) if the APA, CTP or ARM is a legal person, the Member State in which its registered office is situated;
(iii) if the APA, CTP or ARM has, under its national law, no registered office, the Member State in which its head office is situated
host Member State means the Member State, other than the home Member State, in which an investment firm has a branch or provides investment services and/or activities, or the Member State in which a regulated market provides appropriate arrangements so as to facilitate access to trading on its system by remote members or participants established in that same Member State
third-country firm means a firm that would be a credit institution providing investment services or performing investment activities or an investment firm if its head office or registered office were located within the Union
sovereign issuer means any of the following that issues debt instruments:
(i) the Union;
(ii) a Member State, including a government department, an agency, or a special purpose vehicle of the Member State;
(iii) in the case of a federal Member State, a member of the federation;
(iv) a special purpose vehicle for several Member States;
(v) an international financial institution established by two or more Member States which has the purpose of mobilising funding and provide financial assistance to the benefit of its members that are experiencing or threatened by severe financing problems; or
(vi) the European Investment Bank
sovereign debt means a debt instrument issued by a sovereign issuer
durable medium means any instrument which:
(a) enables a client to store information addressed personally to that client in a way accessible for future reference and for a period of time adequate for the purposes of the information; and
(b) allows the unchanged reproduction of the information stored
data reporting services provider means an APA, a CTP or an ARM
working time shall mean:
1. in the case of mobile workers: the time from the beginning to the end of work, during which the mobile worker is at his workstation, at the disposal of the employer and exercising his functions or activities, that is to say:
- the time devoted to all road transport activities. These activities are, in particular, the following:
(i) driving;
(ii) loading and unloading;
(iii) assisting passengers boarding and disembarking from the vehicle;
(iv) cleaning and technical maintenance;
(v) all other work intended to ensure the safety of the vehicle, its cargo and passengers or to fulfil the legal or regulatory obligations directly linked to the specific transport operation under way, including monitoring of loading and unloading, administrative formalities with police, customs, immigration officers etc.,
- the times during which he cannot dispose freely of his time and is required to be at his workstation, ready to take up normal work, with certain tasks associated with being on duty, in particular during periods awaiting loading or unloading where their foreseeable duration is not known in advance, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States;
2. in the case of self-employed drivers, the same definition shall apply to the time from the beginning to the end of work, during which the self employed driver is at his workstation, at the disposal of the client and exercising his functions or activities other than general administrative work that is not directly linked to the specific transport operation under way.
The break times referred to in Article 5, the rest times referred to in Article 6 and, without prejudice to the legislation of Member States or agreements between the social partners providing that such periods should be compensated or limited, the periods of availability referred to in (b) of this Article, shall be excluded from working time
periods of availability shall mean:
- periods other than those relating to break times and rest times during which the mobile worker is not required to remain at his workstation, but must be available to answer any calls to start or resume driving or to carry out other work. In particular such periods of availability shall include periods during which the mobile worker is accompanying a vehicle being transported by ferryboat or by train as well as periods of waiting at frontiers and those due to traffic prohibitions.
These periods and their foreseeable duration shall be known in advance by the mobile worker, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Member States,
- for mobile workers driving in a team, the time spent sitting next to the driver or on the couchette while the vehicle is in motion
workstation shall mean:
- the location of the main place of business of the undertaking for which the person performing mobile road transport activities carries out duties, together with its various subsidiary places of business, regardless of whether they are located in the same place as its head office or main place of business,
- the vehicle which the person performing mobile road transport activities uses when he carries out duties, and
- any other place in which activities connected with transportation are carried out
mobile worker shall mean any worker forming part of the travelling staff, including trainees and apprentices, who is in the service of an undertaking which operates transport services for passengers or goods by road for hire or reward or on its own account
self-employed driver hall mean anyone whose main occupation is to transport passengers or goods by road for hire or reward within the meaning of Community legislation under cover of a Community licence or any other professional authorisation to carry out the aforementioned transport, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers.
For the purposes of this Directive, those drivers who do not satisfy these criteria shall be subject to the same obligations and benefit from the same rights as those provided for mobile workers by this Directive
person performing mobile road transport activities shall mean any mobile worker or self-employed driver who performs such activities
night time shall mean a period of at least four hours, as defined by national law, between 00.00 hours and 07.00 hours
night work shall mean any work performed during night time
safety and/or health signs means signs referring to a specific object, activity or situation and providing information or instructions about safety and/or health at work by means of a signboard, a colour, an illuminated sign or acoustic signal, a verbal communication or a hand signal, as the case may be
prohibition sign means a sign prohibiting behaviour likely to incur or cause danger
warning sign means a sign giving warning of a hazard or danger
mandatory sign means a sign prescribing specific behaviour
emergency escape or first-aid sign means a sign giving information on emergency exits or first-aid or rescue facilities
signboard means a sign which provides specific information by a combination of a geometric shape, colours and a symbol or pictogram and which is rendered visible by lighting of sufficient intensity
supplementary signboard means a signboard used together with one of the signs described under (g), which provides supplementary information
safety colour means a colour to which a specific meaning is assigned
symbol or pictogram means a figure which describes a situation or prescribes specific behaviour and which is used on a signboard or illuminated surface
illuminated sign means a sign produced by a device made of transparent or translucent materials which are illuminated from the inside or the rear in such a way as to give the appearance of a luminous surface
acoustic signal means a coded sound signal which is released and transmitted by a device designed for that purpose, without the use of a human or artificial voice
verbal communication means a predetermined spoken message communicated by a human or artificial voice
hand signal a movement and/or position of the arms and/or hands, in coded form, for guiding persons who are carrying out manoeuvres which constitute a hazard or danger for workers
biological agents shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity
micro-organism shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material
cell culture shall mean the in-vitro growth of cells derived from multicellular organisms
carcinogen means:
(i) a substance or mixture which meets the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 2 );
(ii) a substance, mixture or process referred to in Annex I to this Directive as well as a substance or mixture released by a process referred to in that Annex
mutagen means: a substance or mixture which meets the criteria for classification as a category 1A or 1B germ cell mutagen set out in Annex I to Regulation (EC) No 1272/2008
limit value means, unless otherwise specified, the limit of the time-weighted average of the concentration for a ‘carcinogen or mutagen’ in the air within the breathing zone of a worker in relation to a specified reference period as set out in Annex III to this Directive
insurance distribution means the activities of advising on, proposing, or carrying out other work preparatory to the conclusion of contracts of insurance, of concluding such contracts, or of assisting in the administration and performance of such contracts, in particular in the event of a claim, including the provision of information concerning one or more insurance contracts in accordance with criteria selected by customers through a website or other media and the compilation of an insurance product ranking list, including price and product comparison, or a discount on the price of an insurance contract, when the customer is able to directly or indirectly conclude an insurance contract using a website or other media
reinsurance distribution means the activities of advising on, proposing, or carrying out other work preparatory to the conclusion of contracts of reinsurance, of concluding such contracts, or of assisting in the administration and performance of such contracts, in particular in the event of a claim, including when carried out by a reinsurance undertaking without the intervention of a reinsurance intermediary
insurance intermediary means any natural or legal person, other than an insurance or reinsurance undertaking or their employees and other than an ancillary insurance intermediary, who, for remuneration, takes up or pursues the activity of insurance distribution
ancillary insurance intermediary means any natural or legal person, other than a credit institution or an investment firm as defined in points (1) and (2) of Article 4(1) of Regulation (EU) No 575/2013 of the European Parliament and of the Council, who, for remuneration, takes up or pursues the activity of insurance distribution on an ancillary basis, provided that all the following conditions are met:
(a) the principal professional activity of that natural or legal person is other than insurance distribution;
(b) the natural or legal person only distributes certain insurance products that are complementary to a good or service;
(c) the insurance products concerned do not cover life assurance or liability risks, unless that cover complements the good or service which the intermediary provides as its principal professional activity
reinsurance intermediary means any natural or legal person, other than a reinsurance undertaking or its employees, who, for remuneration, takes up or pursues the activity of reinsurance distribution
insurance distributor means any insurance intermediary, ancillary insurance intermediary or insurance undertaking
remuneration means any commission, fee, charge or other payment, including an economic benefit of any kind or any other financial or non-financial advantage or incentive offered or given in respect of insurance distribution activities
home Member State means:
(a) where the intermediary is a natural person, the Member State in which his or her residence is situated;
(b) where the intermediary is a legal person, the Member State in which its registered office is situated or, if under its national law it has no registered office, the Member State in which its head office is situated
host Member State means the Member State in which an insurance or reinsurance intermediary has a permanent presence or establishment or provides services, and which is not its home Member State
branch means an agency or a branch of an intermediary which is located in the territory of a Member State other than the home Member State
primary place of business means the location from where the main business is managed
advice means the provision of a personal recommendation to a customer, either upon their request or at the initiative of the insurance distributor, in respect of one or more insurance contracts
insurance-based investment product means an insurance product which offers a maturity or surrender value and where that maturity or surrender value is wholly or partially exposed, directly or indirectly, to market fluctuations, and does not include:
(a) non-life insurance products as listed in Annex I to Directive 2009/138/EC (Classes of non-life insurance);
(b) life insurance contracts where the benefits under the contract are payable only on death or in respect of incapacity due to injury, sickness or disability;
(c) pension products which, under national law, are recognised as having the primary purpose of providing the investor with an income in retirement, and which entitle the investor to certain benefits;
(d) officially recognised occupational pension schemes falling under the scope of Directive 2003/41/EC or Directive 2009/138/EC;
(e) individual pension products for which a financial contribution from the employer is required by national law and where the employer or the employee has no choice as to the pension product or provider
durable medium means any instrument which:
(a) enables a customer to store information addressed personally to that customer in a way accessible for future reference and for a period of time adequate for the purposes of the information; and
(b) allows the unchanged reproduction of the information stored
provider means any legal person contracted by a manufacturer or importer of tobacco products for the purpose of establishing and operating its primary repository and the related services
data portability means the ability to move data among different repositories, by the use of technology that is readily available on the market and commonly used in the sector
competent authority means the authority of a Member State which has been designated as such by the Member State concerned
competent court means the court, tribunal or other body of a Member State which has been designated as such by the Member State concerned
double taxation means the imposition by two or more Member States of taxes covered by an agreement or convention referred to in Article 1 in respect of the same taxable income or capital when it gives rise to either: (i) an additional tax charge; (ii) an increase in tax liabilities; or (iii) the cancellation or reduction of losses that could be used to offset taxable profits
affected person means any person, including an individual, that is a resident of a Member State for tax purposes, and whose taxation is directly affected by a question in dispute
packaging shall mean all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer. ‘Non-returnable’ items used for the same purposes shall also be considered to constitute packaging.
‘Packaging’ consists only of:
(a) sales packaging or primary packaging, i. e. packaging conceived so as to constitute a sales unit to the final user or consumer at the point of purchase;
(b) grouped packaging or secondary packaging, i. e. packaging conceived so as to constitute at the point of purchase a grouping of a certain number of sales units whether the latter is sold as such to the final user or consumer or whether it serves only as a means to replenish the shelves at the point of sale; it can be removed from the product without affecting its characteristics;
(c) transport packaging or tertiary packaging, i. e. packaging conceived so as to facilitate handling and transport of a number of sales units or grouped packagings in order to prevent physical handling and transport damage. Transport packaging does not include road, rail, ship and air containers
plastic shall mean a polymer within the meaning of Article 3(5) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council, to which additives or other substances may have been added, and which is capable of functioning as a main structural component of carrier bags
plastic carrier bags shall mean carrier bags, with or without handle, made of plastic, which are supplied to consumers at the point of sale of goods or products
lightweight plastic carrier bags shall mean plastic carrier bags with a wall thickness below 50 microns
very lightweight plastic carrier bags shall mean plastic carrier bags with a wall thickness below 15 microns which are required for hygiene purposes or provided as primary packaging for loose food when this helps to prevent food wastage
oxo-degradable plastic carrier bags shall mean plastic carrier bags made of plastic materials that include additives which catalyse the fragmentation of the plastic material into micro-fragments
packaging waste shall mean any packaging or packaging material covered by the definition of waste laid down in Article 3 of Directive 2008/98/EC, excluding production residues
reusable packaging shall mean packaging which has been conceived, designed and placed on the market to accomplish within its lifecycle multiple trips or rotations by being refilled or reused for the same purpose for which it was conceive
composite packaging shall mean packaging made of two or more layers of different materials which cannot be separated by hand and form a single integral unit, consisting of an inner receptacle and an outer enclosure, that it is filled, stored, transported and emptied as such
economic operators in relation to packaging shall mean suppliers of packaging materials, packaging producers and converters, fillers and users, importers, traders and distributors, authorities and statutory organizations
voluntary agreement shall mean the formal agreement concluded between the competent public authorities of the Member State and the economic sectors concerned, which has to be open to all partners who wish to meet the conditions of the agreement with a view to working towards the objectives of this Directive
official measures means measures taken:
(a) by State authorities; or
(b) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or
(c) in the case of ancillary activities which are also under State control, by any natural person duly sworn for that purpose;
provided that the persons mentioned under (b) and (c) derive no private gain from such measures
authentication element means an element of a security feature
overt means directly perceptible by one or more of the human senses without recourse to external devices. The ‘overt’ category of authentication solutions referred to in ISO 12931:2012 shall be presumed to meet this definition
semi-covert means not directly perceptible by the human senses but detectable by those senses through the use of external devices, such as a UV torch or a special pen or marker, which do not require expert knowledge or specialist training. The ‘covert’ category of authentication solutions authenticated with off-the-shelf tools referred to in ISO 12931:2012 shall be presumed to meet this definition
covert means not directly perceptible by the human senses and detectable only through the use of purpose built tools or professional laboratory equipment. The ‘covert’ categories of authentication solutions requiring purpose built tools and forensic analysis referred to in ISO 12931:2012 shall be presumed to meet this definition
marketing hall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
— the supply of seed to official testing and inspection bodies,
— the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall no be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the certification authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure referred to in Article 46(2)
basic seed means seed
(i) which has been produced under the responsibility of the breeder according to accepted practices for the maintenance of the variety;
(ii) which is intended for the production of seed of the category ‘certified seed’;
(iii) which, subject to the provisions of Article 22, satisfies the conditions laid down in Annexes I and II for basic seed; and
(iv) which has been found by official examination or, in the case of the conditions laid down in Annex II, either by official examination or examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii)
certified seed means seed
(i) which is produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed;
(ii) which is intended mainly for the production of vegetables;
(iii) which, subject to the provisions of point (b) of Article 22, satisfies the conditions laid down in Annexes I and II for certified seed;
(iv) which has been found by official examination or by examination carried out under official supervision to satisfy the conditions set out in (i), (ii) and (iii);
(v) which is subject to official post-control by check inspection to verify its varietal identity and varietal purity
standard seed means seed
(i) which has sufficient varietal identity and varietal purity;
(ii) which is intended mainly for the production of vegetables;
(iii) which satisfies the conditions laid down in Annex II; and
(iv) which is subject to official post-control by check inspection to verify its varietal identity and varietal purity
official measures means measures taken
(i) by State authorities; or
(ii) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or
(iii) in the case of ancillary activities which are also under State control, by any natural person duly sworn for that purpose;
provided that the persons mentioned under (ii) and (iii) derive no private gain from such measures
EC small packages means packages containing seed up to a maximum net weight of
(i) 5 kg for legumes;
(ii) 500 g for onions, chervil, asparagus, spinach beet or chard, red beet or beetrood, turnips, water melon, gourd, marrows, carrots, radishes, scorzonera or black salsify, spinach, corn-salad or lamb's lettuce;
(iii) 100 g for all other species of vegetable
bunkering means the provision of solid, liquid or gaseous fuel or of any other energy source used for the propulsion of the waterborne vessel as well as for general and specific energy provision on board of the waterborne vessel whilst at berth
cargo-handling means the organisation and handling of cargo between the carrying waterborne vessel and the shore, whether it be for import, export or transit of the cargo, including the processing, lashing, unlashing, stowing, transporting and temporary storage of the cargo on the relevant cargo-handling terminal and directly related to the transporting of the cargo, but excluding, unless the Member State determines otherwise, warehousing, stripping, repackaging or any other value added services related to the cargo
competent authority means any public or private body which, on behalf of a local, regional or national level, is entitled to carry out, under national law or instruments, activities related to the organisation and administration of port activities, in conjunction with or instead of the managing body of the port
dredging means the removal of sand, sediment or other substances from the bottom of the waterway access to the port, or within the port area that falls within the competence of the managing body of the port, including the disposal of the removed materials, in order to allow waterborne vessels to have access to the port; it comprises both the initial removal (capital dredging) and the maintenance dredging carried out in order to keep the waterway accessible, whilst not being a port service offered to the user
managing body of the port means any public or private body which, under national law or instruments, has the objective of carrying out, or is empowered to carry out, at a local level, whether in conjunction with other activities or not, the administration and management of the port infrastructure and one or more of the following tasks in the port concerned: the coordination of port traffic, the management of port traffic, the coordination of the activities of the operators present in the port concerned, and the control of the activities of the operators present in the port concerned
mooring means the berthing and unberthing services, including shifting along the quayside, that are required for the safe operation of a waterborne vessel in the port or in the waterway access to the port
passenger services means the organisation and handling of passengers, their luggage and their vehicles between the carrying waterborne vessel and the shore, and also includes the processing of personal data and the transport of passengers inside the relevant passenger terminal
pilotage means the guidance service of a waterborne vessel by a pilot or a pilotage station in order to allow for safe entry or exit of the waterborne vessel in the waterway access to the port or safe navigation within the port
port infrastructure charge means a charge levied, for the direct or indirect benefit of the managing body of the port or of the competent authority, for the use of infrastructure, facilities and services, including the waterway access to the port concerned, as well as access to the processing of passengers and cargo, but excluding land lease rates and charges having equivalent effect
collection of ship-generated waste and cargo residues means the reception of ship-generated waste and cargo residues by any facility, which is fixed, floating or mobile and capable of receiving ship-generated waste or cargo residues as defined in Directive 2000/59/EC of the European Parliament and of the Council
port service charge means a charge levied for the benefit of the provider of port services and paid by the users of the relevant service
port service contract means a formal and legally binding agreement or an act of equivalent legal effect between a provider of port services and a managing body of the port, or a competent authority, having as its subject-matter the provision of one or more port services, without prejudice to the form of designating providers of port services
provider of port services means any natural or legal person providing, or wishing to provide, for remuneration one or more categories of port services
public service obligation means a requirement defined or determined in order to ensure the provision of those port services or activities of general interest that an operator, if it were considering its own commercial interests, would not assume or would not assume to the same extent or under the same conditions
short sea shipping means the movement of cargo and passengers by sea between ports situated in geographical Europe or between those ports and ports situated in non-European countries having a coastline on the enclosed seas bordering Europe
maritime port means an area of land and water made up of such infrastructure and equipment so as to permit, principally, the reception of waterborne vessels, their loading and unloading, the storage of goods, the receipt and delivery of those goods and the embarkation and disembarkation of passengers, crew and other persons and any other infrastructure necessary for transport operators within the port area
towage means the assistance given to a waterborne vessel by means of a tug in order to allow for a safe entry or exit of the port or safe navigation within the port by providing assistance to the manoeuvring of the waterborne vessel
waterway access means water access to the port from the open sea, such as port approaches, fairways, rivers, sea canals and fjords, provided that such waterway falls within the competence of the managing body of the port
unique identifier means the alphanumeric code enabling the identification of a unit pack or an aggregated packaging of tobacco products
economic operator means any natural or legal person who is involved in the trade of tobacco products, including for export, from the manufacturer to the last economic operator before the first retail outlet
first retail outlet means the facility where tobacco products are placed on the market for the first time, including vending machines used for the sale of tobacco products
export means shipment from the Union to a third country
aggregated packaging means any packaging containing more than one unit packet of tobacco products
facility means any location, building or vending machine where tobacco products are manufactured, stored or placed on the market
anti-tampering device means the device allowing for the recording of the verification process following the application of each unit level unique identifier by means of a video or a log file, which once recorded cannot be further altered by an economic operator
offline flat-files means the electronic files established and maintained by each ID issuer that contain data in a plain text format allowing for the extraction of information encoded in the unique identifiers (excluding the time stamp) used at the unit packet and aggregated packaging levels without accessing the repositories system
registry means the record established and maintained by each ID issuer of all the identifier codes generated for economic operators, operators of first retail outlets, facilities and machines along with the corresponding information
data carrier means a carrier representing data in a form readable with the aid of a device
machine means the equipment used for the manufacture of tobacco products which is integral to the manufacturing process
time stamp means the date and time of occurrence of a particular event recorded in UTC (Coordinated Universal Time) time in a prescribed format
primary repository means a repository storing traceability data relating exclusively to the products of a given manufacturer or importer
secondary repository means a repository containing a copy of all traceability data stored in the primary repositories
router means a device established within the secondary repository that transfers data between different components of the repositories system
repositories system means the system consisting of the primary repositories, the secondary repository and the router
common data dictionary means a set of information describing the contents, format, and structure of a database and the relationship between its elements, used to control access to and manipulation of the databases common for all primary and secondary repositories
working day means every day of work in the Member State for which the ID issuer is competent
trans-loading means any transfer of tobacco products from one vehicle to another during which tobacco products do not enter and exit a facility
vending van means a vehicle used for the delivery of tobacco products to multiple retail outlets in quantities that have not been predetermined in advance of the delivery
securitisation means a transaction or scheme, whereby the credit risk associated with an exposure or a pool of exposures is tranched, having all of the following characteristics:
(a) payments in the transaction or scheme are dependent upon the performance of the exposure or of the pool of exposures;
(b) the subordination of tranches determines the distribution of losses during the ongoing life of the transaction or scheme;
(c) the transaction or scheme does not create exposures which possess all of the characteristics listed in Article 147(8) of Regulation (EU) No 575/2013
ecuritisation special purpose entity or SSPE means a corporation, trust or other entity, other than an originator or sponsor, established for the purpose of carrying out one or more securitisations, the activities of which are limited to those appropriate to accomplishing that objective, the structure of which is intended to isolate the obligations of the SSPE from those of the originator
originator means an entity which:
(a) itself or through related entities, directly or indirectly, was involved in the original agreement which created the obligations or potential obligations of the debtor or potential debtor giving rise to the exposures being securitised; or
(b) purchases a third party’s exposures on its own account and then securitises them
resecuritisation means securitisation where at least one of the underlying exposures is a securitisation position
sponsor means a credit institution, whether located in the Union or not, as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013, or an investment firm as defined in point (1) of Article 4(1) of Directive 2014/65/EU other than an originator, that:
(a) establishes and manages an asset-backed commercial paper programme or other securitisation that purchases exposures from third-party entities, or
(b) establishes an asset-backed commercial paper programme or other securitisation that purchases exposures from third-party entities and delegates the day-to-day active portfolio management involved in that securitisation to an entity authorised to perform such activity in accordance with Directive 2009/65/EC, Directive 2011/61/EU or Directive 2014/65/EU
tranche means a contractually established segment of the credit risk associated with an exposure or a pool of exposures, where a position in the segment entails a risk of credit loss greater than or less than a position of the same amount in another segment, without taking account of credit protection provided by third parties directly to the holders of positions in the segment or in other segments
asset-backed commercial paper programme or ABCP programme means a programme of securitisations the securities issued by which predominantly take the form of asset-backed commercial paper with an original maturity of one year or less
asset-backed commercial paper transaction or ABCP transaction means a securitisation within an ABCP programme
traditional securitisation means a securitisation involving the transfer of the economic interest in the exposures being securitised through the transfer of ownership of those exposures from the originator to an SSPE or through sub-participation by an SSPE, where the securities issued do not represent payment obligations of the originator
synthetic securitisation means a securitisation where the transfer of risk is achieved by the use of credit derivatives or guarantees, and the exposures being securitised remain exposures of the originator
investor means a natural or legal person holding a securitisation position
servicer means an entity that manages a pool of purchased receivables or the underlying credit exposures on a day-to-day basis
liquidity facility means the securitisation position arising from a contractual agreement to provide funding to ensure timeliness of cash flows to investors
revolving exposure means an exposure whereby borrowers’ outstanding balances are permitted to fluctuate based on their decisions to borrow and repay, up to an agreed limit
revolving securitisation means a securitisation where the securitisation structure itself revolves by exposures being added to or removed from the pool of exposures irrespective of whether the exposures revolve or not
early amortisation provision means a contractual clause in a securitisation of revolving exposures or a revolving securitisation which requires, on the occurrence of defined events, investors’ securitisation positions to be redeemed before the originally stated maturity of those positions
first loss tranche means the most subordinated tranche in a securitisation that is the first tranche to bear losses incurred on the securitised exposures and thereby provides protection to the second loss and, where relevant, higher ranking tranches
securitisation position means an exposure to a securitisation
original lender means an entity which, itself or through related entities, directly or indirectly, concluded the original agreement which created the obligations or potential obligations of the debtor or potential debtor giving rise to the exposures being securitised
fully- supported ABCP programme means an ABCP programme that its sponsor directly and fully supports by providing to the SSPE(s) one or more liquidity facilities covering at least all of the following:
(a) all liquidity and credit risks of the ABCP programme;
(b) any material dilution risks of the exposures being securitised;
(c) any other ABCP transaction-level and ABCP programme-level costs if necessary to guarantee to the investor the full payment of any amount under the ABCP
fully supported ABCP transaction means an ABCP transaction supported by a liquidity facility, at transaction level or at ABCP programme level, that covers at least all of the following:
(a) all liquidity and credit risks of the ABCP transaction;
(b) any material dilution risks of the exposures being securitised in the ABCP transaction;
(c) any other ABCP transaction-level and ABCP programme-level costs if necessary to guarantee to the investor the full payment of any amount under the ABCP
securitisation repository means a legal person that centrally collects and maintains the records of securitisations
NPE securitisation means a securitisation backed by a pool of non-performing exposures the nominal value of which makes up not less than 90 % of the entire pool’s nominal value at the time of origination and at any later time where assets are added to or removed from the underlying pool due to replenishment, restructuring or any other relevant reason
credit protection agreement means an agreement concluded between the originator and the investor to transfer the credit risk of securitised exposures from the originator to the investor by means of credit derivatives or guarantees, whereby the originator commits to pay an amount, known as a credit protection premium, to the investor and the investor commits to pay an amount, known as a credit protection payment, to the originator in the event that one of the contractually defined credit events occurs
credit protection premium means the amount the originator has committed to pay to the investor under the credit protection agreement for the credit protection promised by the investor
credit protection payment means the amount the investor has committed to pay to the originator under the credit protection agreement in the event that a credit event defined in the credit protection agreement occurs
synthetic excess spread means the amount that, according to the documentation of a synthetic securitisation, is contractually designated by the originator to absorb losses of the securitised exposures that might occur before the maturity date of the transaction
non-refundable purchase price discount means the difference between the outstanding balance of the exposures in the underlying pool and the price at which those exposures are sold by the originator to the SSPE, where neither the originator nor the original lender are reimbursed for that difference
policies and measures means all instruments which contribute to meeting the objectives of the integrated national energy and climate plans and/or to implement commitments under points (a) and (b) of Article 4(2) of the UNFCCC, which may include those that do not have the limitation and reduction of greenhouse gas emissions or change in the energy system as a primary objective
existing policies and measures means implemented policies and measures and adopted policies and measures
implemented policies and measures means policies and measures for which one or more of the following applies at the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report: directly applicable Union or national law is in force, one or more voluntary agreements have been established, financial resources have been allocated, human resources have been mobilised
adopted policies and measures means policies and measures for which an official government decision has been made by the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report and there is a clear commitment to proceed with implementation
planned policies and measures means options that are under discussion and that have a realistic chance of being adopted and implemented after the date of submission of the integrated national energy and climate plan or of the integrated national energy and climate progress report
system for policies and measures and projections means a system of institutional, legal and procedural arrangements established for reporting policies and measures and projections relating to anthropogenic emissions by sources and removals by sinks of greenhouse gases and to the energy system, inter alia as required by Article 39
projections means forecasts of anthropogenic greenhouse gas emissions by sources and removals by sinks or developments of the energy system, including at least quantitative estimates for a sequence of six future years ending with 0 or 5, immediately following the reporting year
projections without measures means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks that exclude the effects of all policies and measures which are planned, adopted or implemented after the year chosen as the starting point for the relevant projection
projections with measures means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks that encompass the effects, in terms of greenhouse gas emission reductions or developments of the energy system, of policies and measures that have been adopted and implemented
projections with additional measures means projections of anthropogenic greenhouse gas emissions by sources and removals by sinks or developments of the energy system that encompass the effects, in terms of greenhouse gas emission reductions, of policies and measures which have been adopted and implemented to mitigate climate change or meet energy objectives, as well as policies and measures which are planned for that purpose
the Union’s 2030 targets for energy and climate means the Union-wide binding target of at least 40 % domestic reduction in economy-wide greenhouse gas emissions as compared to 1990 to be achieved by 2030, the Union-level binding target of at least 32 % for the share of renewable energy consumed in the Union in 2030, the Union-level headline target of at least 32,5 % for improving energy efficiency in 2030, and the 15 % electricity interconnection target for 2030 or any subsequent targets in this regard agreed by the European Council or by the European Parliament and by the Council for 2030
national inventory system means a system of institutional, legal and procedural arrangements established within a Member State for estimating anthropogenic emissions by sources and removals by sinks of greenhouse gases, and for reporting and archiving inventory information
indicator means a quantitative or qualitative factor or variable that contributes to better understanding progress in implementing
key indicators mean the indicators for the progress made with regard to the five dimensions of the Energy Union as proposed by the Commission
technical corrections means adjustments to the national greenhouse gas inventory estimates made in the context of the review carried out pursuant to Article 38 when the submitted inventory data are incomplete or are prepared in a way that is not consistent with relevant international or Union rules or guidelines and that are intended to replace originally submitted estimates
quality assurance means a planned system of review procedures to ensure that data quality objectives are met and that the best possible estimates and information are reported to support the effectiveness of the quality control programme and to assist Member States
quality control means a system of routine technical activities to measure and control the quality of the information and estimates compiled with the purpose of ensuring data integrity, correctness and completeness, identifying and addressing errors and omissions, documenting and archiving data and other material used, and recording all quality assurance activities
energy efficiency first means taking utmost account in energy planning, and in policy and investment decisions, of alternative cost-efficient energy efficiency measures to make energy demand and energy supply more efficient, in particular by means of cost-effective end-use energy savings, demand response initiatives and more efficient conversion, transmission and distribution of energy, whilst still achieving the objectives of those decisions
SET-Plan means the Strategic Energy Technology Plan as set out in the Commission communication of 15 September 2015, entitled, ‘Towards an Integrated Strategic Energy Technology (SET) Plan: Accelerating the European Energy System Transformation’
early efforts means:
(a) in the context of the assessment of a potential gap between the Union's 2030 target for energy from renewable sources and the collective contributions of Member States, a Member state's achievement of a share of energy from renewable sources above its national binding target for 2020 as set out in Annex I to Directive (EU) 2018/2001 or a Member State's early progress towards its national binding target for 2020;
(b) in the context of Commission recommendations based on the assessment pursuant to point (b) of Article 29(1) with regard to energy from renewable sources, a Member State's early implementation of its contribution to the Union's binding target of at least 32 % of renewable energy in 2030 as measured against its national reference points for renewable energy
regional cooperation means cooperation between two or more Member States engaged in a partnership covering one or more of the five dimensions of the Energy Union
fossil fuel means non-renewable carbon-based energy sources such as solid fuels, natural gas and oil
killing means any intentionally induced process which causes the death of an animal
related operations means operations such as handling, lairaging, restraining, stunning and bleeding of animals taking place in the context and at the location where they are to be killed
animal means any vertebrate animal, excluding reptiles and amphibians
emergency killing means the killing of animals which are injured or have a disease associated with severe pain or suffering and where there is no other practical possibility to alleviate this pain or suffering
lairaging means keeping animals in stalls, pens, covered areas or fields associated with or part of slaughterhouse operations
stunning means any intentionally induced process which causes loss of consciousness and sensibility without pain, including any process resulting in instantaneous death
religious rite means a series of acts related to the slaughter of animals and prescribed by a religion
cultural or sporting events means events which are essentially and predominantly related to long established cultural traditions or sporting activities, including racing or other forms of competitions, where there is no production of meat or other animal products or where that production is marginal compared to the event as such and not economically significant
standard operating procedures means a set of written instructions aimed at achieving uniformity of the performance of a specific function or standard
slaughtering means the killing of animals intended for human consumption
slaughterhouse means any establishment used for slaughtering terrestrial animals which falls within the scope of Regulation (EC) No 853/2004
business operator means any natural or legal person having under its control an undertaking carrying out the killing of animals or any related operations falling within the scope of this Regulation
fur animals means animals of the mammal species primarily reared for the production of fur such as minks, polecats, foxes, raccoons, coypu and chinchillas
depopulation means the process of killing animals for public health, animal health, animal welfare or environmental reasons under the supervision of the competent authority
poultry means farmed birds, including birds that are not considered to be domestic birds but which are farmed as domestic animals, with the exception of ratites
restraint means the application to an animal of any procedure designed to restrict its movements sparing any avoidable pain, fear or agitation in order to facilitate effective stunning and killing
pithing means the laceration of the central nervous tissue and spinal cord by means of an elongated rod-shaped instrument introduced into the cranial cavity
distance contract means any contract concerning financial services concluded between a supplier and a consumer under an organised distance sales or service-provision scheme run by the supplier, who, for the purpose of that contract, makes exclusive use of one or more means of distance communication up to and including the time at which the contract is concluded
financial service means any service of a banking, credit, insurance, personal pension, investment or payment nature
supplier means any natural or legal person, public or private, who, acting in his commercial or professional capacity, is the contractual provider of services subject to distance contracts
consumer means any natural person who, in distance contracts covered by this Directive, is acting for purposes which are outside his trade, business or profession
means of distance communication refers to any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the distance marketing of a service between those parties
durable medium means any instrument which enables the consumer to store information addressed personally to him in a way accessible for future reference for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored
operator or supplier of a means of distance communication means any public or private, natural or legal person whose trade, business or profession involves making one or more means of distance communication available to suppliers
research organisation means a university, including its libraries, a research institute or any other entity, the primary goal of which is to conduct scientific research or to carry out educational activities involving also the conduct of scientific research:
(a) on a not-for-profit basis or by reinvesting all the profits in its scientific research; or
(b) pursuant to a public interest mission recognised by a Member State;
in such a way that the access to the results generated by such scientific research cannot be enjoyed on a preferential basis by an undertaking that exercises a decisive influence upon such organisation
text and data mining means any automated analytical technique aimed at analysing text and data in digital form in order to generate information which includes but is not limited to patterns, trends and correlations
cultural heritage institution means a publicly accessible library or museum, an archive or a film or audio heritage institution
press publication means a collection composed mainly of literary works of a journalistic nature, but which can also include other works or other subject matter, and which:
(a) constitutes an individual item within a periodical or regularly updated publication under a single title, such as a newspaper or a general or special interest magazine;
(b) has the purpose of providing the general public with information related to news or other topics; and
(c) is published in any media under the initiative, editorial responsibility and control of a service provider.
Periodicals that are published for scientific or academic purposes, such as scientific journals, are not press publications for the purposes of this Directive
online content-sharing service provider means a provider of an information society service of which the main or one of the main purposes is to store and give the public access to a large amount of copyright-protected works or other protected subject matter uploaded by its users, which it organises and promotes for profit-making purposes.
Providers of services, such as not-for-profit online encyclopedias, not-for-profit educational and scientific repositories, open source software-developing and-sharing platforms, providers of electronic communications services as defined in Directive (EU) 2018/1972, online marketplaces, business-to-business cloud services and cloud services that allow users to upload content for their own use, are not ‘online content-sharing service providers’ within the meaning of this Directive
covered bond means a debt obligation that is issued by a credit institution in accordance with the provisions of national law transposing the mandatory requirements of this Directive and that is secured by cover assets to which covered bond investors have direct recourse as preferred creditors
covered bond programme means the structural features of a covered bonds issue that are determined by statutory rules and by contractual terms and conditions, in accordance with the permission granted to the credit institution issuing the covered bonds
cover pool means a clearly defined set of assets securing the payment obligations attached to covered bonds that are segregated from other assets held by the credit institution issuing the covered bonds
cover assets means assets included in a cover pool
collateral assets means physical assets and assets in the form of exposures that secure cover assets
segregation means the actions performed by a credit institution issuing covered bonds to identify cover assets and put them legally beyond the reach of creditors other than covered bond investors and counterparties of derivative contracts
specialised mortgage credit institution means a credit institution which funds loans solely or mainly through the issue of covered bonds, which is permitted by law only to carry out mortgage and public sector lending and which is not permitted to take deposits, but which takes other repayable funds from the public
automatic acceleration means a situation in which a covered bond automatically becomes immediately due and payable upon the insolvency or resolution of the issuer and in respect of which the covered bond investors have an enforceable claim for repayment at a time earlier than the original maturity date
primary assets means dominant cover assets that determine the nature of the cover pool
substitution assets means cover assets that contribute to the coverage requirements, other than primary assets
overcollateralisation means the entirety of the statutory, contractual or voluntary level of collateral that exceeds the coverage requirement set out in Article 15
match funding requirements means rules requiring that the cash flows between liabilities and assets falling due be matched by ensuring in contractual terms and conditions that payments from borrowers and counterparties of derivative contracts fall due before payments are made to covered bond investors and to the counterparties of derivative contracts, that the amounts received are at least equal in value to the payments to be made to covered bond investors and to counterparties of derivative contracts, and that the amounts received from borrowers and counterparties of derivative contracts are included in the cover pool in accordance with Article 16(3) until the payments become due to the covered bond investors and counterparties of derivative contracts
net liquidity outflow means all payment outflows falling due on one day, including principal and interest payments and payments under derivative contracts of the covered bond programme, net of all payment inflows falling due on the same day for claims related to the cover assets
extendable maturity structure means a mechanism which provides for the possibility of extending the scheduled maturity of covered bonds for a pre-determined period of time and in the event that a specific trigger occurs
covered bond public supervision means the supervision of covered bond programmes ensuring compliance with, and the enforcement of, the requirements applicable to the issue of covered bonds
special administrator means the person or entity appointed to administrate a covered bond programme in the event of the insolvency of a credit institution issuing covered bonds under that programme, or when such credit institution has been determined to be failing or likely to fail pursuant to Article 32(1) of Directive 2014/59/EU or, in exceptional circumstances, where the relevant competent authority determines that the proper functioning of that credit institution is seriously at risk
ro-ro passenger ship means a ship with facilities to enable road or rail vehicles to roll on and roll off the vessel, and carrying more than 12 passengers
high-speed passenger craft means a craft as defined in Regulation 1 of Chapter X of SOLAS 74, and carrying more than 12 passengers
regular service means a series of ro-ro passenger ship or high-speed passenger craft crossings operated so as to serve traffic between the same two or more ports, or a series of voyages from and to the same port without intermediate calls, either:
(i) according to a published timetable; or
(ii) with crossings so regular or frequent that they constitute a recognisable systematic series
place of production means any premises operated as a single production unit. This may include production sites which are separately managed for phytosanitary purposes
vector means beetles belonging to the genus Monochamus Megerle in Dejean, 1821
flight season of the vector means the period from 1 April to 31 October, except where there is technical-scientific justification for a different duration of the flight season of the vector, taking into account a safety margin of four additional weeks at the beginning and at the end of the expected flight season
wood packaging material means wood or wood products used in supporting, protecting or carrying a commodity, in the form of packing cases, boxes, crates, drums and similar packings, pallets, box pallets and other load boards, pallet collars and dunnage, whether or not actually in use in the transport of objects. Processed wood produced by glue, heat or pressure or a combination thereof and packaging material entirely composed of wood of 6 mm of thickness or less are excluded
plant affected by fire or storm means any susceptible plant which is damaged by fire or storm in a way which allows oviposition by the vector
pan-European service means an activity which is designed and established for users within most or all Member States and which may also extend beyond the airspace of the territory to which the Treaty applies
data services provider (DAT provider) means an organisation, which is:
(a) type 1 DAT provider that processes aeronautical data for use on aircraft and provides an aeronautical database meeting the DQRs, under controlled conditions, for which no corresponding airborne application/equipment compatibility has been determined;
(b) type 2 DAT provider that processes aeronautical data and provides an aeronautical database for use on certified aircraft application/equipment meeting the DQRs for which compatibility with that application/equipment has been determined
payer means a person that holds a payment account and allows a transfer of funds from that payment account, or, where there is no payment account, that gives a transfer of funds order
payee means a person that is the intended recipient of the transfer of funds
intermediary payment service provider means a payment service provider that is not the payment service provider of the payer or of the payee and that receives and transmits a transfer of funds on behalf of the payment service provider of the payer or of the payee or of another intermediary payment service provider
transfer of funds means any transaction at least partially carried out by electronic means on behalf of a payer through a payment service provider, with a view to making funds available to a payee through a payment service provider, irrespective of whether the payer and the payee are the same person and irrespective of whether the payment service provider of the payer and that of the payee are one and the same, including:
(a) a credit transfer as defined in point (1) of Article 2 of Regulation (EU) No 260/2012;
(b) a direct debit as defined in point (2) of Article 2 of Regulation (EU) No 260/2012;
(c) a money remittance as defined in point (13) of Article 4 of Directive 2007/64/EC, whether national or cross border;
(d) a transfer carried out using a payment card, an electronic money instrument, or a mobile phone, or any other digital or IT prepaid or postpaid device with similar characteristics
batch file transfer means a bundle of several individual transfers of funds put together for transmission
unique transaction identifier means a combination of letters, numbers or symbols determined by the payment service provider, in accordance with the protocols of the payment and settlement systems or messaging systems used for the transfer of funds, which permits the traceability of the transaction back to the payer and the payee
person-to-person transfer of funds means a transaction between natural persons acting, as consumers, for purposes other than trade, business or profession
statistics means quantitative and qualitative, aggregated and representative information characterising a collective phenomenon in a considered population
development means the activities aiming at setting up, strengthening and improving the statistical methods, standards and procedures used for the production and dissemination of statistics as well as at designing new statistics and indicators
production means all the activities related to the collection, storage, processing, and analysis necessary for compiling statistics
dissemination means the activity of making statistics and statistical analysis accessible to users
data collection means surveys and all other methods of deriving information from different sources, including administrative sources
statistical unit means the basic observation unit, namely a natural person, a household, an economic operator and other undertakings, referred to by the data
confidential data means data which allow statistical units to be identified, either directly or indirectly, thereby disclosing individual information. To determine whether a statistical unit is identifiable, account shall be taken of all relevant means that might reasonably be used by a third party to identify the statistical unit
use for statistical purposes means the exclusive use for the development and production of statistical results and analyses
direct identification means the identification of a statistical unit from its name or address, or from a publicly accessible identification number
indirect identification means the identification of a statistical unit by any other means than by way of direct identification
officials of the Commission (Eurostat) means the officials of the Communities, within the meaning of Article 1 of the Staff Regulations of Officials of the European Communities, working at the Community statistical authority
other staff of the Commission (Eurostat) means the servants of the Communities, within the meaning of Articles 2 to 5 of the Conditions of Employment of Other Servants of the European Communities, working at the Community statistical authority
liquid market means:
(a) for the purposes of Articles 9, 11, and 18, a market for a financial instrument or a class of financial instruments, where there are ready and willing buyers and sellers on a continuous basis, and where the market is assessed in accordance with the following criteria, taking into consideration the specific market structures of the particular financial instrument or of the particular class of financial instruments:
(i) the average frequency and size of transactions over a range of market conditions, having regard to the nature and life cycle of products within the class of financial instrument;
(ii) the number and type of market participants, including the ratio of market participants to traded financial instruments in a particular product;
(iii) the average size of spreads, where available;
(b) for the purposes of Articles 4, 5 and 14, a market for a financial instrument that is traded daily where the market is assessed according to the following criteria:
(i) the free float;
(ii) the average daily number of transactions in those financial instruments;
(iii) the average daily turnover for those financial instruments
certificates means those securities which are negotiable on the capital market and which in case of a repayment of investment by the issuer are ranked above shares but below unsecured bond instruments and other similar instruments
structured finance products means those securities created to securitise and transfer credit risk associated with a pool of financial assets entitling the security holder to receive regular payments that depend on the cash flow from the underlying assets
exchange-traded derivative means a derivative that is traded on a regulated market or on a third-country market considered to be equivalent to a regulated market in accordance with Article 28 of this Regulation, and as such does not fall within the definition of an OTC derivative as defined in Article 2(7) of Regulation (EU) No 648/2012
actionable indication of interest means a message from one member or participant to another within a trading system in relation to available trading interest that contains all necessary information to agree on a trade
benchmark means any rate, index or figure, made available to the public or published that is periodically or regularly determined by the application of a formula to, or on the basis of the value of one or more underlying assets or prices, including estimated prices, actual or estimated interest rates or other values, or surveys and by reference to which the amount payable under a financial instrument or the value of a financial instrument is determined
liquidity fragmentation means a situation in which:
(a) participants in a trading venue are unable to conclude a transaction with one or more other participants in that venue because of the absence of clearing arrangements to which all participants have access; or
(b) a clearing member or its clients would be forced to hold their positions in a financial instrument in more than one CCP which would limit the potential for the netting of financial exposures
portfolio compression means a risk reduction service in which two or more counterparties wholly or partially terminate some or all of the derivatives submitted by those counterparties for inclusion in the portfolio compression and replace the terminated derivatives with another derivative whose combined notional value is less than the combined notional value of the terminated derivatives
exchange for physical means a transaction in a derivative contract or other financial instrument contingent on the simultaneous execution of an equivalent quantity of an underlying physical asset
package order means an order priced as a single unit:
(a) for the purpose of executing an exchange for physical; or
(b) in two or more financial instruments for the purpose of executing a package transaction
package transaction means:
(a) an exchange for physical; or
(b) a transaction involving the execution of two or more component transactions in financial instruments and which fulfils all of the following criteria:
(i) the transaction is executed between two or more counterparties;
(ii) each component of the transaction bears meaningful economic or financial risk related to all the other components;
(iii) the execution of each component is simultaneous and contingent upon the execution of all the other components
European Maritime Single Window environment (EMSWe) means the legal and technical framework for the electronic transmission of information in relation to reporting obligations for port calls in the Union, which consists of a network of maritime National Single Windows with harmonised reporting interfaces and includes data exchanges via SafeSeaNet and other relevant systems as well as common services for user registry and access management, addressing, ship identification, location codes and information on dangerous and polluting goods and on health
ship means any seagoing vessel or craft operating in the marine environment that is subject to a particular reporting obligation listed in the Annex
maritime National Single Window means a nationally established and operated technical platform for receiving, exchanging and forwarding electronically information to fulfil reporting obligations, which includes commonly defined management of access rights, a harmonised reporting interface module and a graphical user interface for communication with declarants, as well as links with the relevant authorities’ systems and databases at national and at Union level, which enables messages or acknowledgements covering the widest range of decisions taken by all of the participating relevant authorities to be communicated to declarants, and which could also allow, where applicable, for the connection with other reporting means
harmonised reporting interface module means a middleware component of the maritime National Single Window through which information can be exchanged between the information system used by the declarant and the relevant maritime National Single Window
reporting obligation means the information required by the Union and international legal acts listed in the Annex, as well as by the national legislation and requirements referred to in the Annex which has to be provided in connection with a port call
port call means the arrival of a ship at, the stay of a ship in, and the departure of a ship from a maritime port in a Member State
data element means the smallest unit of information which has a unique definition and precise technical characteristics such as format, length and character type
EMSWe data set means the complete list of data elements stemming from reporting obligations
graphical user interface means a web interface for two-way web-based user-to-system data submission to a maritime National Single Window, allowing declarants to enter data manually, inter alia, by means of harmonised digital spreadsheets and functions that enable reporting data elements to be extracted from those spreadsheets, as well as including common functionalities and features that ensure a common navigation flow and data upload experience for the declarants
common addressing service means an additional voluntary service for declarants for initiating direct system-to-system data connections between the system of a declarant and the harmonised reporting interface module of the respective maritime National Single Window
declarant means any natural or legal person who is subject to reporting obligations or any duly authorised natural or legal person acting on that person’s behalf within the limits of the relevant reporting obligation
data service provider means a natural or legal person who provides information and communication technology services to a declarant in relation to reporting obligations
electronic transmission of information means the process of transmitting information that has been encoded digitally, using a revisable structured format which can be used directly for data storage and processing by computers
provider of port services means any natural or legal person who provides one or more categories of the port services listed in Article 1(2) of Regulation (EU) 2017/352 of the European Parliament and of the Council
undefined undefined
taxable person shall mean any person who, independently, carries out in any place any economic activity, whatever the purpose or results of that activity
supply of goods shall mean the transfer of the right to dispose of tangible property as owner
intra-Community distance sales of goods means supplies of goods dispatched or transported by or on behalf of the supplier, including where the supplier intervenes indirectly in the transport or dispatch of the goods, from a Member State other than that in which dispatch or transport of the goods to the customer ends, where the following conditions are met:
(a) the supply of goods is carried out for a taxable person, or a non-taxable legal person, whose intra-Community acquisitions of goods are not subject to VAT pursuant to Article 3(1) or for any other non-taxable person;
(b) the goods supplied are neither new means of transport nor goods supplied after assembly or installation, with or without a trial run, by or on behalf of the supplier
distance sales of goods imported from third territories or third countries means supplies of goods dispatched or transported by or on behalf of the supplier, including where the supplier intervenes indirectly in the transport or dispatch of the goods, from a third territory or third country, to a customer in a Member State, where the following conditions are met:
(a) the supply of goods is carried out for a taxable person, or a non-taxable legal person, whose intra-Community acquisitions of goods are not subject to VAT pursuant to Article 3(1) or for any other non-taxable person;
(b) the goods supplied are neither new means of transport nor goods supplied after assembly or installation, with or without a trial run, by or on behalf of the supplier
transfer to another Member State shall mean the dispatch or transport of movable tangible property by or on behalf of the taxable person, for the purposes of his business, to a destination outside the territory of the Member State in which the property is located, but within the Community.
2. The dispatch or transport of goods for the purposes of any of the following transactions shall not be regarded as a transfer to another Member State:
(a) the supply of the goods by the taxable person within the territory of the Member State in which the dispatch or transport ends, in accordance with the conditions laid down in Article 33; (b) the supply of the goods, for installation or assembly by or on behalf of the supplier, by the taxable person within the territory of the Member State in which dispatch or transport of the goods ends, in accordance with the conditions laid down in Article 36; (c) the supply of the goods by the taxable person on board a ship, an aircraft or a train in the course of a passenger transport operation, in accordance with the conditions laid down in Article 37; (d) the supply of gas through a natural gas system situated within the territory of the Community or any network connected to such a system, the supply of electricity or the supply of heat or cooling energy through heating or cooling networks, in accordance with the conditions laid down in Articles 38 and 39; (e)
the supply of the goods by the taxable person within the territory of the Member State, in accordance with the conditions laid down in Articles 138, 146, 147, 148, 151 or 152; (f) the supply of a service performed for the taxable person and consisting in valuations of, or work on, the goods in question physically carried out within the territory of the Member State in which dispatch or transport of the goods ends, provided that the goods, after being valued or worked upon, are returned to that taxable person in the Member State from which they were initially dispatched or transported; (g)
the temporary use of the goods within the territory of the Member State in which dispatch or transport of the goods ends, for the purposes of the supply of services by the taxable person established within the Member State in which dispatch or transport of the goods began; (h) the temporary use of the goods, for a period not exceeding twenty-four months, within the territory of another Member State, in which the importation of the same goods from a third country with a view to their temporary use would be covered by the arrangements for temporary importation with full exemption from import duties.
intra-Community acquisition of goods shall mean the acquisition of the right to dispose as owner of movable tangible property dispatched or transported to the person acquiring the goods, by or on behalf of the vendor or the person acquiring the goods, in a Member State other than that in which dispatch or transport of the goods began
supply of services shall mean any transaction which does not constitute a supply of goods
telecommunications services shall mean services relating to the transmission, emission or reception of signals, words, images and sounds or information of any nature by wire, radio, optical or other electromagnetic systems, including the related transfer or assignment of the right to use capacity for such transmission, emission or reception, with the inclusion of the provision of access to global information networks
importation of goods shall mean the entry into the Community of goods which are not in free circulation within the meaning of Article 24 of the Treaty
voucher means an instrument where there is an obligation to accept it as consideration or part consideration for a supply of goods or services and where the goods or services to be supplied or the identities of their potential suppliers are either indicated on the instrument itself or in related documentation, including the terms and conditions of use of such instrument
single-purpose voucher means a voucher where the place of supply of the goods or services to which the voucher relates, and the VAT due on those goods or services, are known at the time of issue of the voucher
multi-purpose voucher means a voucher, other than a single-purpose voucher
undefined undefined
section of a passenger transport operation effected within the Community shall mean the section of the operation effected, without a stopover outside the Community, between the point of departure and the point of arrival of the passenger transport operation
point of departure of a passenger transport operation shall mean the first scheduled point of passenger embarkation within the Community, where applicable after a stopover outside the Community
point of arrival of a passenger transport operation shall mean the last scheduled point of disembarkation within the Community of passengers who embarked in the Community, where applicable before a stopover outside the Community
intra-Community transport of goods shall mean any transport of goods in respect of which the place of departure and the place of arrival are situated within the territories of two different Member States
place of departure shall mean the place where transport of the goods actually begins, irrespective of distances covered in order to reach the place where the goods are located and ‘place of arrival’ shall mean the place where transport of the goods actually ends
place of arrival shall mean the place where transport of the goods actually ends
chargeable event shall mean the occurrence by virtue of which the legal conditions necessary for VAT to become chargeable are fulfilled
chargeable VAT shall become ‘chargeable’ when the tax authority becomes entitled under the law, at a given moment, to claim the tax from the person liable to pay, even though the time of payment may be deferred
first place of destination shall mean the place mentioned on the consignment note or on any other document under which the goods are imported into the Member State of importation. If no such mention is made, the first place of destination shall be deemed to be the place of the first transfer of cargo in the Member State of importation
a traveller who is not established within the Community shall mean a traveller whose permanent address or habitual residence is not located within the Community. In that case ‘permanent address or habitual residence’ means the place entered as such in a passport, identity card or other document recognised as an identity document by the Member State within whose territory the supply takes place
warehouses other than customs warehouses shall, in the case of products subject to excise duty, mean the places defined as tax warehouses by Article 4(b) of Directive 92/12/EEC and, in the case of products not subject to excise duty, the places defined as such by the Member States
tax-free shop shall mean any establishment which is situated within an airport or port and which fulfils the conditions laid down by the competent public authorities
authenticity of the origin means the assurance of the identity of the supplier or the issuer of the invoice
integrity of the content means that the content required according to this Directive has not been altered
investment gold shall mean:
(1) gold, in the form of a bar or a wafer of weights accepted by the bullion markets, of a purity equal to or greater than 995 thousandths, whether or not represented by securities;
(2) gold coins of a purity equal to or greater than 900 thousandths and minted after 1800, which are or have been legal tender in the country of origin, and are normally sold at a price which does not exceed the open market value of the gold contained in the coins by more than 80 %
member State of consumption means the Member State in which the supply of services is deemed to take place according to Chapter 3 of Title V
Member State of consumption means one of the following:
(a) in the case of the supply of services, the Member State in which the supply is deemed to take place according to Chapter 3 of Title V;
(b) in the case of intra-Community distance sales of goods, the Member State where the dispatch or transport of the goods to the customer ends;
(c) in the case of the supply of goods made by a taxable person facilitating those supplies in accordance with Article 14a(2) where the dispatch or transport of the goods supplied begins and ends in the same Member State, that Member State
taxable person not established within the Community means a taxable person who has not established his business in the territory of the Community and who has no fixed establishment there
intermediary means a person established in the Community appointed by the taxable person carrying out distance sales of goods imported from third territories or third countries as the person liable for payment of the VAT and to fulfil the obligations laid down in this special scheme in the name and on behalf of the taxable person
member State of identification means the following:
(a) where the taxable person is not established in the Community, the Member State in which he chooses to register;
(b) where the taxable person has established his business outside the Community but has one or more fixed establishments therein, the Member State with a fixed establishment where the taxable person indicates he will make use of this special scheme;
(c) where the taxable person has established his business in a Member State, that Member State;
(d) where the intermediary has established his business in a Member State, that Member State;
(e) where the intermediary has established his business outside the Community but has one or more fixed establishments therein, the Member State with a fixed establishment where the intermediary indicates he will make use of this special scheme.
For the purposes of points (b) and (e), where the taxable person or the intermediary has more than one fixed establishment in the Community he shall be bound by the decision to indicate the Member State of establishment for the calendar year concerned and the two calendar years following
member State of consumption means the Member State where the dispatch or transport of the goods to the customer ends
taxable dealer shall mean a taxable person whose principal activity in respect of purchases of gas, electricity, heat or cooling energy is reselling those products and whose own consumption of those products is negligible
‘battery’ or ‘accumulator’ means any source of electrical energy generated by direct conversion of chemical energy and consisting of one or more primary battery cells (non-rechargeable) or consisting of one or more secondary battery cells (rechargeable)
battery pack means any set of batteries or accumulators that are connected together and/or encapsulated within an outer casing so as to form a complete unit that the end-user is not intended to split up or open
portable battery or accumulator means any battery, button cell, battery pack or accumulator that:
(a) is sealed; and
(b) can be hand-carried; and
(c) is neither an industrial battery or accumulator nor an automotive battery or accumulator
button cell means any small round portable battery or accumulator whose diameter is greater than its height and which is used for special purposes such as hearing aids, watches, small portable equipment and back-up power
automotive battery or accumulator means any battery or accumulator used for automotive starter, lighting or ignition power
industrial battery or accumulator means any battery or accumulator designed for exclusively industrial or professional uses or used in any type of electric vehicle
recycling means the reprocessing in a production process of waste materials for their original purpose or for other purposes, but excluding energy recovery
treatment means any activity carried out on waste batteries and accumulators after they have been handed over to a facility for sorting, preparation for recycling or preparation for disposal
appliance means any electrical or electronic equipment, as defined by Directive 2002/96/EC, which is fully or partly powered by batteries or accumulators or is capable of being so
producer means any person in a Member State that, irrespective of the selling technique used, including by means of distance communication as defined in Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts ( 1 ), places batteries or accumulators, including those incorporated into appliances or vehicles, on the market for the first time within the territory of that Member State on a professional basis
distributor means any person that provides batteries and accumulators on a professional basis to an end-user
placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party within the Community and includes import into the customs territory of the Community
economic operators means any producer, distributor, collector, recycler or other treatment operator
cordless power tool means any hand held appliance powered by a battery or accumulator and intended for maintenance, construction or gardening activities
collection rate means, for a given Member State in a given calendar year, the percentage obtained by dividing the weight of waste portable batteries and accumulators collected in accordance with Article 8(1) of this Directive or with Directive 2002/96/EC in that calendar year by the average weight of portable batteries and accumulators that producers either sell directly to end-users or deliver to third parties in order to sell them to end-users in that Member State during that calendar year and the preceding two calendar years
mismatch outcome means a double deduction or a deduction without inclusion
double deduction means a deduction of the same payment, expenses or losses in the jurisdiction in which the payment has its source, the expenses are incurred or the losses are suffered (payer jurisdiction) and in another jurisdiction (investor jurisdiction). In the case of a payment by a hybrid entity or permanent establishment the payer jurisdiction is the jurisdiction where the hybrid entity or permanent establishment is established or situated
deduction without inclusion means the deduction of a payment or deemed payment between the head office and permanent establishment or between two or more permanent establishments in any jurisdiction in which that payment or deemed payment is treated as made (payer jurisdiction) without a corresponding inclusion for tax purposes of that payment or deemed payment in the payee jurisdiction. The payee jurisdiction is any jurisdiction where that payment or deemed payment is received, or is treated as being received under the laws of any other jurisdiction
deduction means the amount that is treated as deductible from the taxable income under the laws of the payer or investor jurisdiction
inclusion means the amount that is taken into account in the taxable income under the laws of the payee jurisdiction. A payment under a financial instrument shall not be treated as included to the extent that the payment qualifies for any tax relief solely due to the way that payment is characterised under the laws of the payee jurisdiction. The term ‘included’ shall be construed accordingly
tax relief means a tax exemption, reduction in the tax rate or any tax credit or refund (other than a credit for taxes withheld at source)
dual inclusion income means any item of income that is included under the laws of both jurisdictions where the mismatch outcome has arisen
hybrid entity means any entity or arrangement that is regarded as a taxable entity under the laws of one jurisdiction and whose income or expenditure is treated as income or expenditure of one or more other persons under the laws of another jurisdiction
financial instrument means any instrument to the extent that it gives rise to a financing or equity return that is taxed under the rules for taxing debt, equity or derivatives under the laws of either the payee or payer jurisdictions and includes a hybrid transfer
financial trader is a person or entity engaged in the business of regularly buying and selling financial instruments on its own account for the purposes of making a profit
hybrid transfer means any arrangement to transfer a financial instrument where the underlying return on the transferred financial instrument is treated for tax purposes as derived simultaneously by more than one of the parties to that arrangement
on-market hybrid transfer means any hybrid transfer that is entered into by a financial trader in the ordinary course of business, and not as part of a structured arrangement
disregarded permanent establishment means any arrangement that is treated as giving rise to a permanent establishment under the laws of the head office jurisdiction and is not treated as giving rise to a permanent establishment under the laws of the other jurisdiction
consolidated group for financial accounting purposes means a group consisting of all entities which are fully included in consolidated financial statements drawn up in accordance with the International Financial Reporting Standards or the national financial reporting system of a Member State
structured arrangement means an arrangement involving a hybrid mismatch where the mismatch outcome is priced into the terms of the arrangement or an arrangement that has been designed to produce a hybrid mismatch outcome, unless the taxpayer or an associated enterprise could not reasonably have been expected to be aware of the hybrid mismatch and did not share in the value of the tax benefit resulting from the hybrid mismatch
‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current
large-scale stationary industrial tools means a large size assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility
large-scale fixed installation means a large-size combination of several types of apparatus and, where applicable, other devices, which:
(i) are assembled, installed and de-installed by professionals;
(ii) are intended to be used permanently as part of a building or a structure at a pre-defined and dedicated location; and
(iii) can only be replaced by the same specifically designed equipment
non-road mobile machinery means machinery, with on-board power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working
‘waste electrical and electronic equipment’ or ‘WEEE’ means electrical or electronic equipment which is waste within the meaning of Article 3(1) of Directive 2008/98/EC, including all components, sub-assemblies and consumables which are part of the product at the time of discarding
producer means any natural or legal person who, irrespective of the selling technique used, including distance communication within the meaning of Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts:
(i) is established in a Member State and manufactures EEE under his own name or trademark, or has EEE designed or manufactured and markets it under his name or trademark within the territory of that Member State;
(ii) is established in a Member State and resells within the territory of that Member State, under his own name or trademark, equipment produced by other suppliers, a reseller not being regarded as the ‘producer’ if the brand of the producer appears on the equipment, as provided for in point (i);
(iii) is established in a Member State and places on the market of that Member State, on a professional basis, EEE from a third country or from another Member State; or
(iv) sells EEE by means of distance communication directly to private households or to users other than private households in a Member State, and is established in another Member State or in a third country.
Whoever exclusively provides financing under or pursuant to any finance agreement shall not be deemed to be a ‘producer’ unless he also acts as a producer within the meaning of points (i) to (iv)
distributor means any natural or legal person in the supply chain, who makes an EEE available on the market. This definition does not prevent a distributor from being, at the same time, a producer within the meaning of point (f)
WEEE from private households means WEEE which comes from private households and WEEE which comes from commercial, industrial, institutional and other sources which, because of its nature and quantity, is similar to that from private households. Waste from EEE likely to be used by both private households and users other than private households shall in any event be considered to be WEEE from private households
finance agreement means any loan, lease, hiring or deferred sale agreement or arrangement relating to any equipment whether or not the terms of that agreement or arrangement or any collateral agreement or arrangement provide that a transfer of ownership of that equipment will or may take place
making available on the market means any supply of a product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means the first making available of a product on the market within the territory of a Member State on a professional basis
removal means manual, mechanical, chemical or metallurgic handling with the result that hazardous substances, mixtures and components are contained in an identifiable stream or are an identifiable part of a stream within the treatment process. A substance, mixture or component is identifiable if it can be monitored to verify environmentally safe treatment
medical device means a medical device or accessory within the meaning of, respectively, point (a) or (b) of Article 1(2) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices which is EEE
in vitro diagnostic medical device means an in vitro diagnostic device or accessory within the meaning of, respectively, point (b) or (c) of Article 1(2) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices which is EEE
active implantable medical device means an active implantable medical device within the meaning of point (c) of Article 1(2) of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices which is EEE
aid means any measure fulfilling all the criteria laid down in Article 107(1) of the Treaty
aid intensity means the total aid amount expressed as a percentage of eligible costs, both figures expressed in net present value terms at the moment the aid is granted and before any deduction of tax or other charges
airline means any airline with a valid operating licence issued by a Member State or a Member of the Common European Aviation Area pursuant to Regulation (EC) No 1008/2008 of the European Parliament and of the Council
airport charge means a price or a levy collected for the benefit of the airport and paid by the airport users for the use of facilities and services which are exclusively provided by the airport and which are related to landing, take-off, lighting and parking of aircraft, and processing of passengers and freight, includingcharges or fees paid for ground handling services and fees for centralised ground handling infrastructure
airport infrastructure means infrastructure and equipment for the provision of airport services by the airport to airlines and the various service providers, including runways, terminals, aprons, taxiways, centralised ground handling infrastructure and any other facilities that directly support the airport services, excluding infrastructure and equipment which is primarily necessary for pursuing non-aeronautical activities, such as car parks, shops and restaurants
airport means an entity or group of entities performing the economic activity of providing airport services to airlines
airport revenue means the revenue from airport charges net of marketing support or any incentives provided by the airport to the airlines, taking into account revenue stemming from non-aeronautical activities (free of any public support), excluding any public support and compensation for tasks falling within public policy remit, or services of general economic interest
airport services means services provided to airlines by an airport or any of its subsidiaries, to ensure the handling of aircraft, from landing to take-off, and of passengers and freight, so as to enable airlines to provide air transport services, including the provision of ground handling services and the provision of centralised ground handling infrastructure
average annual passenger traffic means a figure determined on the basis of the inbound and outbound passenger traffic during the two financial years preceding that in which the aid is notified or granted in the case of non-notified aid
capital costs means the depreciation of the eligible investment costs into airport infrastructure and equipment, including the underlying costs of financing
capital costs funding gap means the net present value of the difference between the positive and negative cash flows, including investment costs, over the lifetime of the investment in fixed capital assets
catchment area of an airport means a geographic market boundary that is normally set at around 100 kilometres or around 60 minutes travelling time by car, bus, train or high-speed train; however, the catchment area of a given airport may be different and needs to take into account the specificities of each particular airport. The size and shape of the catchment area varies from airport to airport, and depends on various characteristics of the airport, including its business model, location and the destinations it serves
costs of financing means the costs related to debt and equity financing of the eligible costs of the investment; in other words, the costs of financing take into account the proportion of total interest and own capital remuneration that corresponds to the financing of eligible costs of the investment, excluding the financing of working capital, investments in non-aeronautical activities or other investment projects
date of grant of the aid means the date when the Member State took a legally binding commitment to award the aid that can be invoked before a national court
eligible investment costs means the costs relating to investments in airport infrastructure, including planning costs, but excluding investment costs for non-aeronautical activities, investment costs in relation to equipment for ground handling services, ordinary maintenance costs and costs for tasks falling within the public policy remit
ground handling services means services provided to airport users at airports as described in the Annex to Directive 96/67/EC, and any subsequent legislation on access to the ground handling market at airports
high-speed train means a train capable of reaching speeds of over 200 km/h
investment aid means aid to finance fixed capital assets, specifically, to cover the capital costs funding gap
net present value means the difference between the positive and negative cash flows over the lifetime of the investment, discounted to their current value using the cost of capital, that is to say, the normal required rate of return applied by the company in other investment projects of a similar kind or, where not available, the cost of capital of the company as a whole, or expected returns commonly observed in the airport sector
non-aeronautical activities means commercial services to airlines or other users of the airport, such as ancillary services to passengers, freight forwarders or other service providers, renting out of offices and shops, car parking and hotels
operating aid means aid to cover the ‘operating funding gap’, either in the form of an upfront payment or in the form of periodic instalments to cover expected operating costs (periodic lump sum payments)
operating costs means the underlying costs of an airport in respect of the provision of airport services, including cost categories such as cost of personnel, contracted services, communications, waste, energy, maintenance, rent and administration, but excluding the capital costs, marketing support or any other incentives granted to airlines by the airport, and costs falling within a public policy remit
operating funding gap means the operating losses of an airport over the relevant period, discounted to their current value using the cost of capital, that is to say the shortfall (in Net Present Value terms) between airport revenues and operating costs of the airport
reasonable profit margin means a rate of return on capital, for example, measured as an Internal Rate of Return (IRR), that the undertaking is normally expected to make on investments with a similar degree of risk
regional airport means an airport with annual passenger traffic volume of up to 3 million
remote regions mean outermost regions, Malta, Cyprus, Ceuta, Mellila, islands which are part of the territory of a Member State, and sparsely populated areas
sparsely populated areas mean NUTS 2 regions with less than 8 inhabitants per km2 or NUTS 3 regions with less than 12.5 inhabitants per km2 (based on Eurostat data on population density)
start of works means either the start of construction works on the investment, or the first firm commitment to order equipment or other commitment that makes the investment irreversible, whichever comes first, and does not include preparatory works, such as obtaining permits and conducting preliminary feasibility studies
securities means transferable securities as defined in point (44) of Article 4(1) of Directive 2014/65/EU with the exception of money market instruments as defined in point (17) of Article 4(1) of Directive 2014/65/EU, having a maturity of less than 12 months
equity securities means shares and other transferable securities equivalent to shares in companies, as well as any other type of transferable securities giving the right to acquire any of the aforementioned securities as a consequence of their being converted or the rights conferred by them being exercised, provided that securities of the latter type are issued by the issuer of the underlying shares or by an entity belonging to the group of the said issuer
non-equity securities means all securities that are not equity securities
offer of securities to the public means a communication to persons in any form and by any means, presenting sufficient information on the terms of the offer and the securities to be offered, so as to enable an investor to decide to purchase or subscribe for those securities. This definition also applies to the placing of securities through financial intermediaries
qualified investors means persons or entities that are listed in points (1) to (4) of Section I of Annex II to Directive 2014/65/EU, and persons or entities who are, on request, treated as professional clients in accordance with Section II of that Annex, or recognised as eligible counterparties in accordance with Article 30 of Directive 2014/65/EU unless they have entered into an agreement to be treated as non-professional clients in accordance with the fourth paragraph of Section I of that Annex. For the purposes of applying the first sentence of this point, investment firms and credit institutions shall, upon request from the issuer, communicate the classification of their clients to the issuer subject to compliance with the relevant laws on data protection
undefined means any of the following:
(i) companies, which, according to their last annual or consolidated accounts, meet at least two of the following three criteria: an average number of employees during the financial year of less than 250, a total balance sheet not exceeding EUR 43 000 000 and an annual net turnover not exceeding EUR 50 000 000 ;
(ii) small and medium-sized enterprises as defined in point (13) of Article 4(1) of Directive 2014/65/EU
issuer means a legal entity which issues or proposes to issue securities
offeror means a legal entity or individual which offers securities to the public
advertisement means a communication with both of the following characteristics:
(i) relating to a specific offer of securities to the public or to an admission to trading on a regulated market;
(ii) aiming to specifically promote the potential subscription or acquisition of securities
home Member State means:
(i) for all issuers of securities established in the Union which are not mentioned in point (ii), the Member State where the issuer has its registered office;
(ii) for any issues of non-equity securities whose denomination per unit amounts to at least EUR 1 000 , and for any issues of non-equity securities giving the right to acquire any transferable securities or to receive a cash amount, as a consequence of their being converted or the rights conferred by them being exercised, provided that the issuer of the non-equity securities is not the issuer of the underlying securities or an entity belonging to the group of the latter issuer, the Member State where the issuer has its registered office, or where the securities were or are to be admitted to trading on a regulated market or where the securities are offered to the public, at the choice of the issuer, the offeror or the person asking for admission to trading on a regulated market. The same shall apply to non-equity securities in a currency other than euro, provided that the value of such minimum denomination is nearly equivalent to EUR 1 000 ;
(iii) for all issuers of securities established in a third country which are not mentioned in point (ii), the Member State where the securities are intended to be offered to the public for the first time or where the first application for admission to trading on a regulated market is made, at the choice of the issuer, the offeror or the person asking for admission to trading on a regulated market, subject to a subsequent choice by issuers established in a third country in either of the following circumstances:
— where the home Member State was not determined by the choice of those issuers;
— in accordance with point (i)(iii) of Article 2(1) of Directive 2004/109/EC
host Member State means the Member State where an offer of securities to the public is made or admission to trading on a regulated market is sought, when different from the home Member State
competent authority means the authority designated by each Member State in accordance with Article 31, unless otherwise specified in this Regulation
collective investment undertaking other than the closed-end type means unit trusts and investment companies with both of the following characteristics:
(i) they raise capital from a number of investors, with a view to investing it in accordance with a defined investment policy for the benefit of those investors;
(ii) their units are, at the holder’s request, repurchased or redeemed, directly or indirectly, out of their assets
units of a collective investment undertaking means securities issued by a collective investment undertaking as representing the rights of the participants in such an undertaking over its assets
approval means the positive act at the outcome of the scrutiny by the home Member State’s competent authority of the completeness, the consistency and the comprehensibility of the information given in the prospectus
base prospectus means a prospectus that complies with Article 8, and, at the choice of the issuer, the final terms of the offer
working days means working days of the relevant competent authority excluding Saturdays, Sundays and public holidays, as defined in the national law applicable to that competent authority
third country issuer means an issuer established in a third country
offer period means the period during which potential investors may purchase or subscribe for the securities concerned
durable medium means any instrument which:
(i) enables a customer to store information addressed personally to that customer in a way accessible for future reference and for a period adequate for the purposes of the information; and
(ii) allows the unchanged reproduction of the information stored
selling price shall mean the final price for a unit of the product, or a given quantity of the product, including VAT and all other taxes
unit price shall mean the final price, including VAT and all other taxes, for one kilogramme, one litre, one metre, one square metre or one cubic metre of the product or a different single unit of quantity which is widely and customarily used in the Member State concerned in the marketing of specific products
products sold in bulk shall mean products which are not pre-packaged and are measured in the presence of the consumer
trader shall mean any natural or legal person who sells or offers for sale products which fall within his commercial or professional activity
consumer shall mean any natural person who buys a product for purposes that do not fall within the sphere of his commercial or professional activity
consumer means any natural person who, in commercial practices covered by this Directive, is acting for purposes which are outside his trade, business, craft or profession
trader means any natural or legal person who, in commercial practices covered by this Directive, is acting for purposes relating to his trade, business, craft or profession and anyone acting in the name of or on behalf of a trader
product means any good or service including immovable property, digital service and digital content, as well as rights and obligations
business-to-consumer commercial practices (also referred to as commercial practices) means any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product to consumers
to materially distort the economic behaviour of consumers means using a commercial practice to appreciably impair the consumer's ability to make an informed decision, thereby causing the consumer to take a transactional decision that he would not have taken otherwise
code of conduct means an agreement or set of rules not imposed by law, regulation or administrative provision of a Member State which defines the behaviour of traders who undertake to be bound by the code in relation to one or more particular commercial practices or business sectors
code owner means any entity, including a trader or group of traders, which is responsible for the formulation and revision of a code of conduct and/or for monitoring compliance with the code by those who have undertaken to be bound by it
professional diligence means the standard of special skill and care which a trader may reasonably be expected to exercise towards consumers, commensurate with honest market practice and/or the general principle of good faith in the trader's field of activity
invitation to purchase means a commercial communication which indicates characteristics of the product and the price in a way appropriate to the means of the commercial communication used and thereby enables the consumer to make a purchase
undue influence means exploiting a position of power in relation to the consumer so as to apply pressure, even without using or threatening to use physical force, in a way which significantly limits the consumer's ability to make an informed decision
transactional decision means any decision taken by a consumer concerning whether, how and on what terms to purchase, make payment in whole or in part for, retain or dispose of a product or to exercise a contractual right in relation to the product, whether the consumer decides to act or to refrain from acting
regulated profession means a professional activity or a group of professional activities, access to which or the pursuit of which, or one of the modes of pursuing which, is conditional, directly or indirectly, upon possession of specific professional qualifications, pursuant to laws, regulations or administrative provisions
ranking means the relative prominence given to products, as presented, organised or communicated by the trader, irrespective of the technological means used for such presentation, organisation or communication
online marketplace means a service using software, including a website, part of a website or an application, operated by or on behalf of a trader which allows consumers to conclude distance contracts with other traders or consumers
sales contract means any contract under which the seller transfers or undertakes to transfer ownership of goods to a consumer, and the consumer pays or undertakes to pay the price thereof
consumer means any natural person who, in relation to contracts covered by this Directive, is acting for purposes which are outside that person's trade, business, craft or profession
seller means any natural person or any legal person, irrespective of whether privately or publicly owned, that is acting, including through any other person acting in that natural or legal person's name or on that person's behalf, for purposes relating to that person's trade, business, craft or profession, in relation to contracts covered by this Directive
producer means a manufacturer of goods, an importer of goods into the Union or any person purporting to be a producer by placing its name, trade mark or other distinctive sign on the goods
goods means:
(a) any tangible movable items; water, gas and electricity are to be considered as goods within the meaning of this Directive where they are put up for sale in a limited volume or a set quantity;
(b) any tangible movable items that incorporate or are inter-connected with digital content or a digital service in such a way that the absence of that digital content or digital service would prevent the goods from performing their functions (‘goods with digital elements’)
digital content means data which are produced and supplied in digital form
digital service means:
(a) a service that allows the consumer to create, process, store or access data in digital form; or
(b) a service that allows the sharing of or any other interaction with data in digital form uploaded or created by the consumer or other users of that service
compatibility means the ability of the goods to function with hardware or software with which goods of the same type are normally used, without the need to convert the goods, hardware or software
functionality means the ability of the goods to perform their functions having regard to their purpose
interoperability means the ability of the goods to function with hardware or software different from those with which goods of the same type are normally used
durable medium means any instrument which enables the consumer or the seller to store information addressed personally to that person in a way that is accessible for future reference, for a period of time adequate for the purposes of the information, and which allows the unchanged reproduction of the information stored
commercial guarantee means any undertaking by the seller or a producer (the guarantor) to the consumer, in addition to the seller's legal obligation relating to the guarantee of conformity, to reimburse the price paid or to replace, repair or service goods in any way if they do not meet the specifications or any other requirements not related to conformity set out in the guarantee statement or in the relevant advertising available at the time of, or before the conclusion of the contract
durability means the ability of the goods to maintain their required functions and performance through normal use
free of charge means free of the necessary costs incurred in order to bring the goods into conformity, particularly the cost of postage, carriage, labour or materials
public auction means a method of sale where goods or services are offered by the seller to consumers, who attend or are given the possibility to attend the auction in person, through a transparent, competitive bidding procedure run by an auctioneer and where the successful bidder is bound to purchase the goods or services
consumer means any natural person who, in contracts covered by this Directive, is acting for purposes which are outside his trade, business or profession
seller or supplier means any natural or legal person who, in contracts covered by this Directive, is acting for purposes relating to his trade, business or profession, whether publicly owned or privately owned
consumer means any natural person who, in contracts covered by this Directive, is acting for purposes which are outside his trade, business, craft or profession
trader means any natural person or any legal person, irrespective of whether privately or publicly owned, who is acting, including through any other person acting in his name or on his behalf, for purposes relating to his trade, business, craft or profession in relation to contracts covered by this Directive
goods made to the consumer’s specifications means non-prefabricated goods made on the basis of an individual choice of or decision by the consumer
sales contract means any contract under which the trader transfers or undertakes to transfer ownership of goods to the consumer, including any contract having as its object both goods and services
service contract means any contract other than a sales contract under which the trader supplies or undertakes to supply a service, including a digital service, to the consumer
distance contract means any contract concluded between the trader and the consumer under an organised distance sales or service-provision scheme without the simultaneous physical presence of the trader and the consumer, with the exclusive use of one or more means of distance communication up to and including the time at which the contract is concluded
off-premises contract means any contract between the trader and the consumer:
(a) concluded in the simultaneous physical presence of the trader and the consumer, in a place which is not the business premises of the trader;
(b) for which an offer was made by the consumer in the same circumstances as referred to in point (a);
(c) concluded on the business premises of the trader or through any means of distance communication immediately after the consumer was personally and individually addressed in a place which is not the business premises of the trader in the simultaneous physical presence of the trader and the consumer; or
(d) concluded during an excursion organised by the trader with the aim or effect of promoting and selling goods or services to the consumer
business premises means:
(a) any immovable retail premises where the trader carries out his activity on a permanent basis; or
(b) any movable retail premises where the trader carries out his activity on a usual basis
durable medium means any instrument which enables the consumer or the trader to store information addressed personally to him in a way accessible for future reference for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored
financial service means any service of a banking, credit, insurance, personal pension, investment or payment nature
public auction means a method of sale where goods or services are offered by the trader to consumers, who attend or are given the possibility to attend the auction in person, through a transparent, competitive bidding procedure run by an auctioneer and where the successful bidder is bound to purchase the goods or services
commercial guarantee means any undertaking by the trader or a producer (the guarantor) to the consumer, in addition to his legal obligation relating to the guarantee of conformity, to reimburse the price paid or to replace, repair or service goods in any way if they do not meet the specifications or any other requirements not related to conformity set out in the guarantee statement or in the relevant advertising available at the time of, or before the conclusion of the contract
ancillary contract means a contract by which the consumer acquires goods or services related to a distance contract or an off-premises contract and where those goods are supplied or those services are provided by the trader or by a third party on the basis of an arrangement between that third party and the trader
online marketplace means a service using software, including a website, part of a website or an application, operated by or on behalf of a trader which allows consumers to conclude distance contracts with other traders or consumers
provider of an online marketplace means any trader which provides an online marketplace to consumers
consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession
trader means any natural persons, or any legal person irrespective of whether privately or publicly owned, who is acting, including through any person acting in his name or on his behalf, for purposes relating to his trade, business, craft or profession
sales contract means any contract under which the trader transfers or undertakes to transfer the ownership of goods to the consumer and the consumer pays or undertakes to pay the price thereof, including any contract having as its object both goods and services
service contract means any contract other than a sales contract under which the trader supplies or undertakes to supply a service to the consumer and the consumer pays or undertakes to pay the price thereof
domestic dispute means a contractual dispute arising from a sales or service contract where, at the time the consumer orders the goods or services, the consumer is resident in the same Member State as that in which the trader is established
cross-border dispute means a contractual dispute arising from a sales or service contract where, at the time the consumer orders the goods or services, the consumer is resident in a Member State other than the Member State in which the trader is established
ADR entity means any entity, however named or referred to, which is established on a durable basis and offers the resolution of a dispute through an ADR procedure and that is listed in accordance with Article 20(2)
competent authority means any public authority designated by a Member State for the purposes of this Directive and established at national, regional or local level
project means:
— the execution of construction works or of other installations or schemes,
— other interventions in the natural surroundings and landscape including those involving the extraction of mineral resources
developer means the applicant for authorisation for a private project or the public authority which initiates a project
development consent means the decision of the competent authority or authorities which entitles the developer to proceed with the project
public means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups
public concerned means the public affected or likely to be affected by, or having an interest in, the environmental decision-making procedures referred to in Article 2(2). For the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest
competent authority or authorities means that authority or those authorities which the Member States designate as responsible for performing the duties arising from this Directive
environmental impact assessment means a process consisting of:
(i) the preparation of an environmental impact assessment report by the developer, as referred to in Article 5(1) and (2);
(ii) the carrying out of consultations as referred to in Article 6 and, where relevant, Article 7;
(iii) the examination by the competent authority of the information presented in the environmental impact assessment report and any supplementary information provided, where necessary, by the developer in accordance with Article 5(3), and any relevant information received through the consultations under Articles 6 and 7;
(iv) the reasoned conclusion by the competent authority on the significant effects of the project on the environment, taking into account the results of the examination referred to in point (iii) and, where appropriate, its own supplementary examination; and
(v) the integration of the competent authority's reasoned conclusion into any of the decisions referred to in Article 8a
organic production means the use, including during the conversion period referred to in Article 10, of production methods that comply with this Regulation at all stages of production, preparation and distribution
organic production means a product resulting from organic production, other than a product produced during the conversion period referred to in Article 10. The products of hunting or fishing of wild animals are not considered as organic products
agricultural raw material means an agricultural product that has not been subjected to any operation of preservation or processing
preventive measures means measures that are to be taken by operators at every stage of production, preparation and distribution in order to ensure the preservation of biodiversity and soil quality, measures for the prevention and control of pests and diseases and measures that are to be taken to avoid negative effects on the environment, animal health and plant health
precautionary measures means measures that are to be taken by operators at every stage of production, preparation, and distribution to avoid contamination with products or substances that are not authorised for use in organic production in accordance with this Regulation, and to avoid the commingling of organic products with non-organic products
conversion means the transition from non-organic to organic production within a given period, during which the provisions of this Regulation concerning organic production apply
in-conversion product means a product that is produced during the conversion period referred to in Article 10
holding means all the production units operated under single management for the purpose of producing live or unprocessed agricultural products, including products originating from aquaculture and beekeeping, referred to in point (a) of Article 2(1) or products listed in Annex I other than essential oils and yeast
production unit means all assets of a holding, such as primary production premises, land parcels, pasturages, open air areas, livestock buildings or parts thereof, hives, fish ponds, containment systems and sites for algae or aquaculture animals, rearing units, shore or seabed concessions, and premises for the storage of crops, of crop products, of algae products, of animal products, of raw materials and of any other relevant inputs managed as described in point (10), point (11) or point (12)
organic production unit means a production unit, excluding during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production
in-conversion production unit means a production unit, during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production; it may be constituted of land parcels or other assets for which the conversion period referred to in Article 10 starts at different moments in time
non-organic production unit means a production unit which is not managed in compliance with the requirements applicable to organic production
operator means the natural or legal person responsible for ensuring that this Regulation is complied with at every stage of production, preparation and distribution that are under that person’s control
farmer means a natural or legal person, or a group of natural or legal persons, regardless of the legal status of that group and its members under national law, who exercises an agricultural activity
plant reproductive material means plants and all parts of plants, including seeds, at any stage of growth that are capable of, and intended for, producing entire plants
organic heterogeneous material means a plant grouping within a single botanical taxon of the lowest known rank which:
(a) presents common phenotypic characteristics;
(b) is characterised by a high level of genetic and phenotypic diversity between individual reproductive units, so that that plant grouping is represented by the material as a whole, and not by a small number of units;
(c) is not a variety within the meaning of Article 5(2) of Council Regulation (EC) No 2100/94;
(d) is not a mixture of varieties; and
(e) has been produced in accordance with this Regulation
mother plant means an identified plant from which plant reproductive material is taken for the reproduction of new plants
generation means mixtures traditionally used in biodynamic farming
plant production means production of agricultural crop products including harvesting of wild plant products for commercial purposes
biodynamic preparations means mixtures traditionally used in biodynamic farming
livestock production means the production of domestic or domesticated terrestrial animals, including insects
veranda means an additional, roofed, uninsulated, outdoor part of a building intended for poultry, the longest side usually being equipped with wire fencing or netting, with an outdoor climate, natural and, where necessary, artificial illumination, and a littered floor
pullets means young animals of the Gallus gallus species that are of an age of less than 18 weeks
laying hens means animals of the Gallus gallus species that are intended for the production of eggs for consumption and that are of an age of at least 18 weeks
closed recirculation aquaculture facility means a facility on land or in a vessel where aquaculture takes place within an enclosed environment involving the recirculation of water and which depends on permanent external energy input to stabilise the environment for the aquaculture animals
energy from renewable sources means energy from renewable non-fossil sources such as wind, solar, geothermal, wave, tidal, hydropower, landfill gas, sewage treatment plant gas and biogases
hatchery means a place for the breeding, hatching and rearing through the early life stages of aquaculture animals, in particular finfish and shellfish
nursery means a place where an intermediate aquaculture production system is applied between the hatchery and grow-out stages. The nursery stage is completed within the first third of the production cycle, with the exception of species undergoing a smoltification process
polyculture means the rearing in aquaculture of two or more species, usually from different trophic levels, in the same culture unit
polycultureproduction cycle means the lifespan of an aquaculture animal or alga, from the earliest life stage (fertilised eggs, in the case of aquaculture animals) to harvesting
locally grown species means aquaculture species which are neither alien nor locally absent species within the meaning of points (6) and (7), respectively, of Article 3 of Council Regulation (EC) No 708/2007, as well as the species listed in Annex IV to that Regulation
veterinary treatment means all courses of a curative or preventive treatment against an occurrence of a specific disease
preparation means the operations of preserving or processing of organic or in-conversion products, or any other operation that is carried out on an unprocessed product without altering the initial product, such as slaughtering, cutting, cleaning or milling, as well as packaging, labelling or alterations made to the labelling relating to organic production
traceability means the ability to trace and follow food, feed or any product referred to in Article 2(1), and any substance intended or expected to be incorporated into food, feed or any product referred to in Article 2(1), through all stages of production, preparation and distribution
stage of production, preparation and distribution means any stage from the primary production of an organic product through its storage, processing, transport, and sale or supply to the final consumer, including, where relevant, labelling, advertising, import, export and subcontracting activities
ingredient means an ingredient as defined in point (f) of Article 2(2) of Regulation (EU) No 1169/2011 or, for products other than food, any substance or product used in the manufacture or preparation of products that is still present in the finished product, even in altered form
labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a product that are placed on any packaging, document, notice, label, ring or collar that accompanies or refers to that product
advertising means any presentation of products to the public, by any means other than a label, that is intended or is likely to influence and shape attitudes, beliefs and behaviours in order to directly or indirectly promote the sale of products
control authority means an organic control authority as defined in point (4) of Article 3 of Regulation (EU) 2017/625, or an authority recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union
control body means a delegated body as defined in point (5) of Article 3 of Regulation (EU) 2017/625, or a body recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union
non-compliance means non-compliance with this Regulation or non-compliance with the delegated or implementing acts adopted in accordance with this Regulation
genetically modified organism or GMO means a genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council which is not obtained through the techniques of genetic modification listed in Annex I.B to that Directive
produced from GMOs means derived in whole or in part from GMOs but not containing or consisting of GMOs
produced by GMOs means derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs
equivalence means meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity
poultry house means a fixed or mobile building for accommodating flocks of poultry, which includes all surfaces covered by roofs, including a veranda; the house may be subdivided into separate compartments, each accommodating a single flock
soil-related crop cultivation means production in living soil or in soil that is mixed or fertilised with materials and products that are allowed in organic production in connection with the subsoil and bedrock
integrity of organic or in-conversion products means the fact that the product does not exhibit non-compliance which:
(a) in any stage of production, preparation and distribution affects the organic or in-conversion characteristics of the product; or
(b) is repetitive or intentional
pen means an enclosure that includes a part in which animals are provided with protection from adverse weather conditions
fattening poultry means poultry intended for meat production
flock in the context of compartments in poultry houses means a group of birds that are kept together not mixing with other poultry species, and with their own dedicated indoor and outdoor areas
brother rooster means male chicken of laying hen strains intended for meat production
poularde means female Gallus gallus intended for meat production and slaughtered at the minimum age of 120 days
importer means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848, who presents the consignment for release for free circulation in the Union either on its own, or through a representative
operator responsible for the consignment means, for the purposes of Article 6(4) of Delegated Regulation (EU) 2021/2306 and Commission Delegated Regulation (EU) 2019/2123, either the importer or a natural or legal person established in the Union who presents the consignment at the border control post on behalf of the importer
first consignee means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848 to whom the consignment is delivered by the importer after the release for free circulation and who receives it for further preparation and/or marketing
consignee means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848 to whom the batch obtained from the splitting of a consignment is delivered by the importer after the release for free circulation and who receives it for further preparation and/or marketing
consignment means a consignment, as defined in Article 3, point (37), of Regulation (EU) 2017/625 of the European Parliament and of the Council, of products intended to be placed on the market within the Union as organic products or in-conversion products; however, in case of organic products and in-conversion products exempted from official controls at border control posts in accordance with Commission Delegated Regulation (EU) 2021/2305, it means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country
parental material means any plant material the crossing or propagation of which resulted in organic heterogeneous material
small packages means packages containing seed up to the maximum quantities provided for in Annex II
capital company means:
(a) any company which takes one of the forms listed in Annex I;
(b) any company, firm, association or legal person the shares in whose capital or assets can be dealt in on a stock exchange;
(c) any company, firm, association or legal person operating for profit, whose members have the right to dispose of their shares to third parties without prior authorisation and are only responsible for the debts of the company, firm, association or legal person to the extent of their shares
electrical and electronic equipment or EEE means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current
large-scale stationary industrial tools means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility
large-scale fixed installation means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals
cables means all cables with a rated voltage of less than 250 volts that serve as a connection or an extension to connect EEE to the electrical outlet or to connect two or more EEE to each other
manufacturer means any natural or legal person who manufactures an EEE or who has an EEE designed or manufactured and markets it under his name or trademark
authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks
distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EEE available on the market
importer means any natural or legal person established within the Union, who places an EEE from a third country on the Union market
economic operators means the manufacturer, the authorised representative, the importer and the distributor
making available on the market means any supply of an EEE for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge
placing on the market means making available an EEE on the Union market for the first time
harmonised standard means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services on the basis of a request made by the Commission in accordance with Article 6 of Directive 98/34/EC
technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service
CE marking means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing
conformity assessment means the process demonstrating whether the requirements of this Directive relating to an EEE, are met
market surveillance means the activities carried out and measures taken by public authorities to ensure that EEE complies with the requirements set out in this Directive and does not endanger health, safety or other issues of public interest protection
recall means any measure aimed at achieving the return of a product that has already been made available to the end user
withdrawal means any measure aimed at preventing a product in the supply chain from being made available on the market
homogeneous material means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes
industrial monitoring and control instruments means monitoring and control instruments designed for exclusively industrial or professional use
availability of a substitute means the ability of a substitute to be manufactured and delivered within a reasonable period of time as compared with the time required for manufacturing and delivering the substances listed in Annex II
reliability of a substitute means the probability that an EEE using a substitute will perform a required function without failure under stated conditions for a stated period of time
spare part means a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part
non-road mobile machinery made available exclusively for professional use means machinery, with an on-board power source or with a traction drive powered by an external power source, the operation of which requires either mobility or continuous or semi-continuous movement between a succession of fixed working locations while working, and which is made available exclusively for professional use
external power supply means a device which meets all of the following criteria:
(a) it is designed to convert alternating current (AC) power input from the mains power source input into one or more lower voltage direct current (DC) or AC outputs;
(b) it is used with one or more separate devices that constitute the primary load;
(c) it is contained in a physical enclosure separate from the device or devices that constitute the primary load;
(d) it is connected to the device or devices that constitute the primary load with removable or hard-wired male/female electrical connections, cables, cords or other wirings;
(e) it has nameplate output power not exceeding 250 watts; and
(f) it is used with electrical and electronic household and office equipment included in Annex I
low voltage external power supply means an external power supply with a nameplate output voltage of less than 6 volts and a nameplate output current greater than or equal to 550 milliamperes
multiple voltage output external power supply means an external power supply able to convert AC power input from the mains power source into more than one simultaneous output at lower DC or AC voltage
voltage converter means a device converting the 230 volts mains power source input to 110 volts power output with characteristics similar to mains power source input characteristics
uninterruptible power supply means a device that automatically provides backup power when the electrical power from the mains power source drops to an unacceptable voltage level
battery charger means a device that connects directly to a removable battery at its output interface
lighting converter means an external power supply used with extra low voltage light sources
active power over Ethernet injector means a device that converts the mains power source input to a lower DC voltage output, has one or more Ethernet input and/or one or more Ethernet output ports, delivers power to one or several devices connected to the Ethernet output port(s), and provides the rated voltage at the output ports(s) only when compatible devices are detected following a standardised process
docking station for autonomous appliances means a device in which a battery-operated appliance that executes tasks requiring the appliance to move without any user intervention is placed for charging, and that can guide the independent movements of the appliance
mains means the electricity supply from the grid of 230 (± 10 %) volts of alternating current at 50 Hz
information technology equipment means any equipment which has a primary function of either entry, storage, display, retrieval, transmission, processing, switching, or control, of data or of telecommunication messages or a combination of these functions and may be equipped with one or more terminal ports typically operated for information transfer
domestic environment means an environment where the use of broadcast radio and television receivers may be expected within a distance of 10 m of the equipment concerned
nameplate output power means the maximum output power as specified by the manufacturer
no-load condition means the condition in which the input of an external power supply is connected to the mains power source, but the output is not connected to any primary load
active mode means a condition in which the input of an external power supply is connected to the mains power source and the output is connected to a primary load
active mode efficiency means the ratio of the power produced by an external power supply in active mode to the input power required to produce it
average active efficiency means the average of the active mode efficiencies at 25 %, 50 %, 75 % and 100 % of the nameplate output power
equivalent model means a model which has the same technical characteristics relevant for the technical information to be provided, but which is placed on the market or put into service by the same manufacturer, importer or authorised representative as another model with a different model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer’s, importer’s or authorised representative’s name
refrigerating appliance with a direct sales function means an insulated cabinet with one or more compartments that are controlled at specific temperatures, cooled by natural or forced convection through one or more energy consuming means and is intended for displaying and selling, with or without assisted serving, foodstuffs and other items at specified temperatures below the ambient temperature to customers, accessible directly through open sides or through one or more doors, or drawers or both, including refrigerating appliances with a direct sales function with areas used for storage of foodstuffs and other items not accessible by customers, and excluding minibars and wine storage appliances
foodstuffs means food, ingredients, beverages, including wine, and other items primarily used for consumption which require refrigeration at specified temperatures
condensing unit means a product integrating at least one electrically driven compressor and one condenser, capable of cooling down and continuously maintaining low or medium temperature inside a refrigerated appliance or system, using a vapour compression cycle once connected to an evaporator and an expansion device, as defined in Regulation (EU) 2015/1095
remote cabinet means a refrigerating appliance with a direct sales function which consists of a factory-made assembly of components that in order to function as a refrigerating appliance with a direct sales function, needs to be connected additionally to remote components (condensing unit and/or compressor and/or water condensed unit) which are not an integral part of the cabinet
food processing refrigerating appliance with a direct sales function means a refrigerating appliance with a direct sales function specifically tested and approved for carrying out food processing such as ice-cream makers, microwave-equipped refrigerated vending machines or ice makers; this does not include refrigerating appliances with a direct sales function equipped with one compartment specifically designed for carrying out food processing which is equivalent to less than 20 % of the appliance total net volume
net volume means the part of the gross volume of any compartment which is left after deduction of the volume of components and spaces unusable for the storage or display of foodstuffs and other items, in cubic decimetres (dm3) or litres (L)
gross volume means the volume within the inside liners of the compartment, without internal fittings and with door or lid closed, in cubic decimetres (dm3) or litres (L)
specifically tested and approved means that the product complies with all the following requirements:
(a) it has been specifically designed and tested for the mentioned operating condition or application, according to the Union legislation mentioned or related acts, relevant Member State legislation, and/or relevant European or international standards;
(b) it is accompanied by evidence, to be included in the technical documentation in the form of a certificate, a type approval mark or a test report, that the product has been specifically approved for the mentioned operating condition or application;
(c) it is placed on the market specifically for the mentioned operating condition or application, as evidenced at least by the technical documentation, information provided for the product and any advertising, information or marketing materials
wine storage appliance means refrigerating appliance with only one type of compartment for the storage of wine, with precision temperature control for the storage conditions and target temperature, and equipped with anti-vibration measures, as defined in Regulation (EU) 2019/2019
compartment means an enclosed space within a refrigerating appliance with a direct sales function, separated from other compartment(s) by a partition, container, or similar construction, which is directly accessible through one or more external doors and may itself be divided into sub-compartments. For the purpose of this Regulation, unless specified otherwise, compartment refers to both compartments and sub-compartments
external door is the part of a refrigerating appliance with a direct sales function that can be moved or removed to at least allow inserting the load from the exterior to the interior or extracting the load from the interior to the exterior of the refrigerating appliance with a direct sales function
sub-compartment means an enclosed space in a compartment having a different operating temperature range from the compartment in which it is located
minibar means a refrigerating appliance with a total volume of maximum 60 litres, which is primary intended for the storage and sales of foodstuffs in hotel rooms and similar premises, as defined in Regulation (EU) 2019/2019
refrigerated drum vending machine means a refrigerated vending machine with rotating drums each divided in partitions, in which the foodstuffs and other items are placed on a horizontal surface, and are retrieved through individual delivery doors
refrigerated vending machine means a refrigerating appliance with a direct sales function designed to accept consumer payments or tokens to dispense chilled foodstuffs or other items without on-site labour intervention
saladette means a refrigerating appliance with a direct sales function with one or more doors or drawer fronts in the vertical plane that has cut-outs in the top surface into which temporary storage bins can be inserted for easy-access storage of foodstuffs such as pizza toppings or salad items
horizontal serve-over counter with integrated storage means a horizontal cabinet for assisted service, which includes refrigerated storage which is of at least 100 litres (L) per meter (m) length and which is normally placed at the serve-over counter's base
horizontal cabinet means a refrigerating appliance with a direct sales function with horizontal display, opening on its top, and accessible from above
chilled operating temperature means a temperature between -3,5 degrees Celsius (°C) and 15 degrees Celsius (°C) for appliances equipped with energy management systems for saving energy and between -3,5 degrees Celsius (°C) and 10 degrees Celsius (°C) for appliances not equipped with energy management systems for saving energy
operating temperature means the reference temperature inside a compartment during testing
corner/curved cabinet means a refrigerating appliance with a direct sales function used to achieve geometrical continuity between two linear cabinets that are at an angle to each other and/or that form a curve. A corner/curved cabinet does not have a recognisable longitudinal axis or length since it consists only of a filling shape (wedge or similar) and is not designed to function as a stand-alone refrigerated unit. The two ends of the corner/curved cabinet are inclined at an angle between 30 ° and 90 °
frozen operating temperature means a temperature below -12 degrees Celsius (°C)
serve-over fish counter with flaked ice means a cabinet for horizontal assisted service, designed and marketed specifically for fresh fish display. It is characterised by having on its top a bed of flaked ice used to maintain the temperature of the displayed fresh fish, and it also has a built in drain outlet
equivalent model means a model which has the same technical characteristics relevant for the technical information to be provided, but which is placed on the market or put into service by the same manufacturer, importer or authorised representative as another model with a different model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer's, importer's or authorised representative's name
product database means a collection of data concerning products, which is arranged in a systematic manner and consists of a consumer-oriented public part, where information concerning individual product parameters is accessible by electronic means, an online portal for accessibility and a compliance part, with clearly specified accessibility and security requirements, as referred to in Regulation (EU) 2017/1369 of the European Parliament and of the Council
beverage cooler means a refrigerating appliance with a direct sales function designed to cool, at a specified speed, packaged non-perishable beverages, excluding wine, loaded at ambient temperature, for sale at specified temperatures below the ambient temperature. A beverage cooler allows accessing the beverages directly through open sides or through one or more doors, drawers or both. The temperature inside the cooler may increase during periods of no demand, for the purpose of energy saving, in view of the non-perishable nature of beverages
energy efficiency index (EEI) means an index number for the relative energy efficiency of a refrigeration appliance with a direct sales function expressed in percentage, calculated in accordance with point 2 of Annex III
carousel cabinet means a round/circular shape supermarket cabinet which can be installed as a standalone unit or as a unit connecting two linear supermarket cabinets. Carousel cabinets can also be equipped with a turning system which makes visible the display of foodstuff at 360 °
supermarket cabinet means a refrigerating appliance with a direct sales function intended for the sale and display of foodstuffs and other items in retail applications, such as in supermarkets. Beverage coolers, refrigerated vending machines, gelato-scooping cabinets and ice-cream freezers are not considered supermarket cabinets
spare part means a separate part that can replace a part with the same or similar function in a product
professional repairer means an operator or undertaking which provides services of repair and professional maintenance of refrigerating appliances with a direct sales function
door gasket means a mechanical seal which fills the space between the door and the cabinet of the refrigerating appliance with a direct sales function to prevent leakage from the cabinet to the outdoor air
vacuum insulation panel (VIP) means an insulation panel consisting of a firm, highly-porous material encased in a thin, gas-tight outer envelope, from which the gases are evacuated and which is sealed to prevent outside gases from entering the panel
ice-cream freezer means a horizontal cabinet intended to store and/or display and sell pre-packed ice cream, where access by the consumer to the pre-packed ice cream is achieved by opening a non-transparent or transparent lid from the top, with a net volume ≤ 600 litres (L) and, only in the case of transparent lid ice-cream freezers, a net volume divided by the total display area ≥ 0,35 meters (m)
transparent lid means a door made of a transparent material that covers at least 75 % of the door surface and that allows the end-user to see items through it
total display area (TDA) means the total visible foodstuffs and other items area, including visible area through glazing, defined by the sum of horizontal and vertical projected surface areas of the net volume, expressed in square meters (m2)
guarantee means any undertaking by the retailer or a manufacturer, importer or authorised representative to the consumer, to:
(a) reimburse the price paid; or
(b) replace, repair or handle refrigerating appliances with a direct sales function in any way if they do not meet the specifications set out in the guarantee statement or in the relevant advertising
gelato-scooping cabinet means a refrigerating appliance with a direct sales function in which ice-cream can be stored, displayed and scooped, within prescribed temperature limits as set out in Annex III, Table 5
annual energy consumption (AE) means the average daily energy consumption multiplied by 365 (days per year), expressed in kilowatt hour per year (kWh/a), calculated in accordance with point 2(b) of Annex III
daily energy consumption (Edaily ) means the energy used by a refrigerating appliance with a direct sales function over 24 hours at reference conditions, expressed in kilowatt hour per day (kWh/24h)
standard annual energy consumption (SAE) means the reference annual energy consumption of a refrigeration appliance with a direct sales function, expressed in kilowatt hour per year (kWh/a), calculated in accordance with point 2(c) of Annex III
temperature coefficient (C) means a correction factor that accounts for the difference in operating temperature
climate class factor (CC) means a correction factor that accounts for the difference in ambient conditions for which the refrigerating appliance is designed for
integral cabinet means a refrigerating appliance with a direct sales function that has an integrated refrigeration system which incorporates a compressor and condensing unit
refrigerator means a refrigerating appliance with a direct sales function that continuously maintains the temperature of the products stored in the cabinet at chilled operating temperature
freezer means a refrigerating appliance with a direct sales function that continuously maintains the temperature of the products stored in the cabinet at frozen operating temperature
vertical cabinet means a refrigerating appliance with a direct sales function with a vertical or inclined display opening from the front
combined cabinet means a refrigerating appliance with a direct sales function which combines display and opening directions from a vertical and a horizontal cabinet
declared values means the values provided by the manufacturer, importer or authorised representative for the stated, calculated or measured technical parameters in accordance with Article 4, for the verification of compliance by the Member State authorities
roll-in cabinet means a supermarket cabinet which enables goods to be displayed directly on their pallets or rolls which can be placed inside by lifting, swinging, or removing the lower front part, where fitted
M-package means a test package fitted with a temperature measuring device
multi-temperature vending machine means a refrigerated vending machine including at least two compartments with different operating temperatures
mains or electric mains means the electricity supply from the grid of 230 (± 10 %) volts of alternating current at 50 Hz
household dishwasher means a machine which cleans and rinses tableware, and which is declared by the manufacturer in the Declaration of Conformity to comply with Directive 2014/35/EU of the European Parliament and of the Council or with Directive 2014/53/EU of the European Parliament and of the Council
built-in household dishwasher means a household dishwasher that is designed, tested and marketed exclusively:
(a) to be installed in cabinetry or encased (top, bottom and sides) by panels;
(b) to be securely fastened to the sides, top or floor of the cabinetry or panels; and
(c) to be equipped with an integral factory-finished face or to be fitted with a custom front panel
equivalent model means a model which has the same technical characteristics relevant for the technical information to be provided, but which is placed on the market or put into service by the same manufacturer, importer or authorised representative as another model with a different model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer's, importer's or authorised representative's name
product database means a collection of data concerning products, which is arranged in a systematic manner and consists of a consumer-oriented public part, where information concerning individual product parameters is accessible by electronic means, an online portal for accessibility and a compliance part, with clearly specified accessibility and security requirements, as laid down in Regulation (EU) 2017/1369
programme means a series of operations that are pre-defined and are declared by the manufacturer, importer or authorised representative as suitable for specified levels of soil or types of load, or both
eco means the name of the programme of a household dishwasher declared by the manufacturer, importer or authorised representative as suitable to clean normally soiled tableware, and to which the ecodesign requirements on energy efficiency, cleaning and drying performance relate
Energy Efficiency Index (EEI) means the ratio of the eco programme energy consumption to the standard programme energy consumption
eco programme energy consumption (EPEC) means the energy consumption of a household dishwasher for the eco programme, expressed in kilowatt hour per cycle
standard programme energy consumption (SPEC) means the energy consumption taken as a reference as a function of the rated capacity, expressed in kilowatt hour per cycle
place setting (ps) means a set of tableware for use by one person, not including serving pieces
serving pieces means items for the preparation and serving of food which can include pots, serving bowls, serving cutlery and a platter
rated capacity means the maximum number of place settings together with the serving pieces, which can be cleaned, rinsed and dried in a household dishwasher in one cycle when loaded in accordance with the manufacturer’s, importer’s or authorised representative’s instructions
cleaning performance index (IC) means the ratio of the cleaning performance of a household dishwasher to the cleaning performance of a reference household dishwasher
drying performance index (ID) means the ratio of the drying performance of a household dishwasher to the drying performance of a reference household dishwasher
programme duration (Tt) means the length of time beginning with the initiation of the programme selected, excluding any user programmed delay, until the end of the programme is indicated and the user has access to the load
cycle means a complete cleaning, rinsing and drying process, as defined by the programme selected, consisting of a series of operations until all activity ceases
off mode means a condition in which the household dishwasher is connected to the mains and is not providing any function; the following shall also be considered as off mode:
(a) conditions providing only an indication of off mode;
(b) conditions providing only functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2014/30/EU of the European Parliament and of the Council
standby mode means a condition where the household dishwasher is connected to the mains, and provides only the following functions, which may persist for an indefinite time:
(a) reactivation function, or reactivation function and a mere indication of enabled reactivation function; and/or
(b) reactivation function through a connection to a network; and/or
(c) information or status display; and/or
(d) detection function for emergency measures
network means a communication infrastructure with a topology of links, an architecture, including the physical components, organisational principles, communication procedures and formats (protocols)
delay start means a condition where the user has selected a specified delay to the beginning of the cycle of the selected programme
spare part means a separate part that can replace a part with the same or similar function in a product
professional repairer means an operator or undertaking which provides services of repair and professional maintenance of household dishwashers
eco programme water consumption (EPWC) means the water consumption of a household dishwasher for the eco programme, expressed in litres per cycle
guarantee means any undertaking by the retailer or a manufacturer to the consumer to:
(a) reimburse the price paid; or
(b) replace, repair or handle household dishwashers in any way if they do not meet the specifications set out in the guarantee statement or in the relevant advertising
declared values means the values provided by the manufacturer, importer or authorised representative for the stated, calculated or measured technical parameters in accordance with Article 4, for the verification of compliance by the Member State authorities
mains or electric mains means the electricity supply from the grid of 230 (± 10 %) volts of alternating current at 50 Hz
household dishwasher means a machine which cleans and rinses tableware, and which is declared by the manufacturer in the Declaration of Conformity to comply with Directive 2014/35/EU of the European Parliament and of the Council or with Directive 2014/53/EU of the European Parliament and of the Council
built-in household dishwasher means a household dishwasher that is designed, tested and marketed exclusively:
(a) to be installed in cabinetry or encased (top, bottom and sides) by panels;
(b) to be securely fastened to the sides, top or floor of the cabinetry or panels; and
(c) to be equipped with an integral factory-finished face or to be fitted with a custom front panel
point of sale means a location where household dishwashers are displayed or offered for sale, hire or hire-purchase
Energy Efficiency Index (EEI) means the ratio of the eco programme energy consumption to the standard programme energy consumption
eco programme energy consumption (EPEC) means the energy consumption of a household dishwasher for the eco programme, expressed in kilowatt hour per cycle
standard programme energy consumption (SPEC) means the energy consumption taken as a reference as a function of the rated capacity of the household dishwasher, expressed in kilowatt hour per cycle
programme means a series of operations that are pre-defined and are declared by the supplier as suitable for specified levels of soil or types of load, or both
cycle means a complete cleaning, rinsing, and drying process, as defined by the programme selected, consisting of a series of operations until all activity ceases
quick response (QR) code means a matrix barcode included on the energy label of a product model that links to that model’s information in the public part of the product database
place setting (ps) means a set of tableware for use by one person, not including serving pieces
serving pieces means items for the preparation and serving of food which can include pots, serving bowls, serving cutlery and a platter
rated capacity means the maximum number of place settings together with the serving pieces, which can be cleaned, rinsed and dried in a household dishwasher in one cycle when loaded in accordance with the supplier’s instructions
eco programme water consumption (EPWC) means the water consumption of a household dishwasher for the eco programme, expressed in litres per cycle
cleaning performance index (IC) means the ratio of the cleaning performance of a household dishwasher to the cleaning performance of a reference household dishwasher
drying performance index (ID) means the ratio of the drying performance of a household dishwasher to the drying performance of a reference household dishwasher
programme duration (Tt) means the length of time beginning with the initiation of the programme selected, excluding any user programmed delay, until the end of the programme is indicated and the user has access to the load
eco means the name of the programme of a household dishwasher declared by the manufacturer as suitable to clean normally soiled tableware, and to which the information on the energy label and the product information sheet relates
off mode means a condition in which the household dishwasher is connected to the mains and is not providing any function; the following shall also be considered as off mode:
(a) conditions providing only an indication of off mode;
(b) conditions providing only functionalities intended to ensure electromagnetic compatibility pursuant to Directive 2014/30/EU of the European Parliament and of the Council
standby mode means a condition where the household dishwasher is connected to the mains and provides only the following functions, which may persist for an indefinite time:
(a) reactivation function, or reactivation function and a mere indication of enabled reactivation function, and/or
(b) reactivation function through a connection to a network; and/or
(c) information or status display, and/or
(d) detection function for emergency measures
network means a communication infrastructure with a topology of links, an architecture, including the physical components, organisational principles, communication procedures and formats (protocols)
delay start means a condition where the user has selected a specified delay to the beginning of the cycle of the selected programme
guarantee means any undertaking by the retailer or supplier to the consumer to:
(a) reimburse the price paid; or
(b) replace, repair or handle the household dishwashers in any way if they do not meet the specifications set out in the guarantee statement or in the relevant advertising
display mechanism means any screen, including tactile screen, or other visual technology used for displaying internet content to users
nested display means any visual interface where an image or data set is accessed by a mouse click, mouse roll-over or tactile screen expansion of another image or data set
tactile screen means a screen responding to touch, such as that of a tablet computer, slate computer or a smartphone
alternative text means text provided as an alternative to a graphic allowing information to be presented in non-graphical form where display devices cannot render the graphic or as an aid to accessibility such as input to voice synthesis applications
declared values means the values provided by the supplier for the stated, calculated or measured technical parameters, pursuant to Article 3(3) of Regulation (EU) 2017/1369 and in accordance with Article 3(1)(d) and Annex VI of this Regulation, for the verification of compliance by the Member State authorities
interest means income from debt-claims of every kind, whether or not secured by mortgage and whether or not carrying a right to participate in the debtor's profits, and in particular, income from securities and income from bonds or debentures, including premiums and prizes attaching to such securities, bonds or debentures; penalty charges for late payment shall not be regarded as interest
royalties means payments of any kind received as a consideration for the use of, or the right to use, any copyright of literary, artistic or scientific work, including cinematograph films and software, any patent, trade mark, design or model, plan, secret formula or process, or for information concerning industrial, commercial or scientific experience; payments for the use of, or the right to use, industrial, commercial or scientific equipment shall be regarded as royalties
permanent establishment means a fixed place of business situated in a Member State through which the business of a company of another Member State is wholly or partly carried on
welding equipment means products that are used for manual, automated or semi-automated welding, brazing, soldering or cutting (or all of the above) via arc welding and allied processes, and that is stationary or transportable, and consists of linked parts or components, at least one of which moves and which are joined together to produce coalescence of metals by heating them to the welding temperature (with or without the application of pressure) or by the application of pressure alone, with or without the use of filler metal, and with or without the use of shielding gas(es), using appropriate tools and techniques, resulting in a product of defined geometry
manual metal arc welding means an arc-welding process with a coated electrode where the operator’s hand controls the travel speed of the welding operation and the rate at which the electrode is fed into the electric arc
shielded metal arc welding means an arc-welding process whereby coalescence is produced by heating with an electric arc between a covered metal electrode and the work-piece and work area. Shielding is obtained from decomposition of the electrode covering. Pressure is not used and filler metal is obtained from the electrode
self-shielded flux-cored welding means a wire welding process in which a continuous hollow-wire electrode is fed through the welding gun into the weld joint without the need to use an external shielding gas to protect the weld pool from contamination. Instead of an external shielding gas, a flux compound within the hollow wire reacts with the welding arc to form a gas that protects the weld pool
flux cored arc welding means a welding process that uses composite tubular filler metal electrodes consisting of a metal sheath and a core of various powdered materials, producing an extensive slag cover on the face of a weld bead. The use of external shield gas(es) may or may not be required
metal inert gas welding means a gas metal arc welding process whereby coalescence is produced by heating with an arc between a continuous filler metal (consumable) electrode and the workpiece area. Shielding is obtained entirely from an externally supplied gas, or gas mixture, that is inert
metal active gas welding means a gas metal arc welding process whereby coalescence is produced by heating with an arc between a continuous filler metal (consumable) electrode and the workpiece area. Shielding is obtained entirely from an externally supplied gas, or gas mixture, that is active
tungsten inert gas welding means an arc welding process whereby coalescence is produced by heating with an arc between a single tungsten (non-consumable) electrode and the workpiece area. Shielding is obtained from a gas or gas mixture. Pressure may or may not be used and filler metal may or may not be used
plasma arc cutting means an arc cutting process that uses a constricted arc and removes the molten metal in a high velocity jet of ionised gas (plasma gas) issuing from the constricting orifice. Plasma arc cutting is a direct-current electrode-negative process
plasma gas (also referred to as orifice gas or cutting gas) means a gas directed into the torch to surround the electrode, which becomes ionised by the arc to form a plasma and issues from the torch nozzle as the plasma jet
shielding gas (also referred to as secondary gas) means a gas that does not pass through the orifice of the nozzle, but instead passes around the nozzle and forms a shield around the electric arc
submerged arc welding means an arc welding process that uses an arc or arcs exceeding 600 amperes between a bare metal electrode or electrodes and the weld pool. The arc and molten metal are shielded by a blanket of granular flux on the workpieces. No pressure is applied and the process uses filler metal from the electrode and sometimes from a supplementary source such as a welding rod, flux or metal granules
limited-duty arc welding means arc welding and allied processes that are not for industrial and professional applications and that:
(a) use single-phase public low-voltage input;
(b) if engine driven, do not exceed an output power of 7,5 kVA;
(c) do not require arc-striking and stabilising devices, liquid cooling systems or gas consoles for operation
resistance welding means a thermo-electrical process in which heat is generated at the interface of the parts to be joined by passing an electrical current through the parts for a precisely controlled time and under a controlled pressure. No consumables such as welding rods or shielding gases are required
stud welding means a welding process in which a metal stud or a similar part is joined (manually, in automated or in semi-automated way) to a workpiece using an arc of electricity to heat both parts
equivalent model means a model which has the same technical characteristics relevant for the technical information to be provided, but which is placed on the market or put into service by the same manufacturer or authorised representative or importer as another model with a different model identifier
model identifier means the code, usually alphanumeric, which distinguishes a specific product model from other models with the same trade mark or the same manufacturer’s, authorised representative’s or importer’s name
power source efficiency means the ratio, expressed in a percentage, of the output power at standardised welding conditions and standardised welding load voltages, to the highest power consumption of the power source
idle state means the operating state in which the power is switched on and the welding circuit is not energised
idle state power consumption means the power demand, in watts, in idle state
power source means a device that utilises alternating current (AC) to either power one or more AC power outputs, or which converts AC to one or more DC power outputs, for the purpose of powering a welding equipment
control panel means an overall operating interface, containing controls and indicators, between the user and the welding equipment
equipment housing means a casing intended to protect the product from the environment, including ambient humidity and possible shock impacts
welding torch means a device which delivers the welding current to the electrode, which may include transferring the current to a consumable electrode, where used, and which also delivers the shielding gas, where used, to the electric arc area
gas supply hose means a supply hose specifically designed for supply of fuel gases (such as acetylene), compressed air and shielding gases used in welding, normally consisting of a tube and a protective cover, often specific to the gas type used, and sometimes to the operating conditions
gas supply regulator means a device which reduces the higher pressure of the supplied compressed gases to the lower pressure that can be safely used in the welding equipment, often equipped with a metering valve or flowmeter to measure and/or control gas flow
welding wire drive means a device, used to feed welding wire or filler material, that may be of the type of push, pull or a push-pull combination
fan means a rotary bladed machine used to maintain a continuous flow of gas, typically air, passing through it and acts for instance as the internal cooling system for the power source
electricity supply cable means an electric energy supply cable meeting the performance and safety requirements of internationally recognised welding cable standards
professional repairer means an operator or undertaking which provides services of repair and professional maintenance for welding equipment
spare part means a separate part that can replace a part with the same or similar function in a welding equipment

EU Law

Комунікаційна команда Офісу Віцепрем'єрки з питань європейської та євроатлантичної інтеграції