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