any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product’s use, considered acceptable and consistent with a high level of protection of the health and safety of consumers
a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property
a component: — which serves to fulfil a safety function, — which is independently placed on the market, — the failure and/or malfunction of which endangers the safety of persons, and — which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function. An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a)
a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endanger the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function
a function that serves to fulfil a protective measure designed to eliminate, or, if that is not possible, to reduce, a risk, which, if it fails, could result in an increase of that risk
requirements on the safety of using fluorinated greenhouse gases and natural refrigerants or products and equipment containing or relying on them, prohibiting the use of certain fluorinated greenhouse gases or their alternatives, including when contained in a product or in equipment at a specific place of intended utilisation due to site and application specificities that are set out in:
any instrument, equipment, mechanism, apparatus, appurtenance, software or accessory that is used or intended to be used to contribute to the safe operation of aircraft at an aerodrome
the mechanism for effecting a transfer by a resolution authority of shares or other instruments of ownership issued by an institution under resolution, or assets, rights or liabilities, of an institution under resolution to a purchaser that is not a bridge institution, in accordance with Article 38
the mechanism for effecting a transfer by a resolution authority of instruments of ownership issued by an institution under resolution, or assets, rights or liabilities of an institution under resolution, to a purchaser that is not a bridge institution, in accordance with Article 24
the area dedicated to the display of goods offered for sale, to the payment for such goods, and to the circulation and presence of customers, but does not include the areas which are not open to the public, such as storage areas, or other areas where products are not displayed, such as car parks; in the context of e-commerce packaging, the storage and dispatch area is to be considered as sales area
any contract under which the trader transfers or undertakes to transfer the ownership of goods to the consumer and the consumer pays or undertakes to pay the price thereof, including any contract having as its object both goods and services
any contract under which the trader transfers or undertakes to transfer the ownership of goods to the consumer and the consumer pays or undertakes to pay the price thereof, including any contract having as its object both goods and services
any contract under which the seller transfers or undertakes to transfer ownership of goods to a consumer, and the consumer pays or undertakes to pay the price thereof
one of the units, which may be an operation, a project within an operation or a payment claim by a beneficiary, into which an audit population is divided for the purpose of sampling
the Committee of the United Nations Security Council which was established pursuant to paragraph 18 of United Nations Security Council Resolution ("UNSCR") 1737 (2006)
a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox
scheme targeted at a limited number of specific sectors of economic activity
a scheme which covers activities falling within the scope of less than five classes (four-digit numerical code) of the NACE Rev. 2 statistical classification.
an instrument of general application, such as a law or regulation, and accompanying administrative requirements, implementing rules or guidelines, setting out the terms, conditions and procedures to assess, investigate, authorise, condition, prohibit or unwind foreign direct investments on grounds of security or public order
a structured framework of cooperation in relation to a given geographical area, developed by Union institutions, Member States, their regions and where appropriate third countries sharing a sea basin; a sea basin strategy takes into account the geographic, climatic, economic and political specificities of the sea basin
the quality label attributed by the Commission in respect of a proposal, which shows that the proposal which has been assessed in a call for proposals under a Union instrument is deemed to comply with the minimum quality requirements of that Union instrument, but could not be funded due to lack of budget available for that call for proposals, and might receive support from other Union or national sources of funding.
a quality label which shows that a proposal submitted to a call for proposals under the Programme has passed all of the evaluation thresholds set out in the work programme, but could not be funded due to a lack of budget available for that call for proposals in the work programme, and might receive support from other Union or national sources of funding
a quality label which shows that a proposal submitted to a call for proposals exceeded all of the evaluation thresholds set out in the work programme, but could not be funded due to lack of budget available for that call for proposals in the work programme and might receive support from other Union or national sources of funding
any information in any format, including textual, graphic, vocal or other outputs, returned in response to, and related to, a search query, irrespective of whether the information returned is a paid or an unpaid result, a direct answer or any product, service or information offered in connection with the organic results, or displayed along with or partly or entirely embedded in them
any Member State in which the EU Blue Card holder intends to exercise or exercises the right of mobility within the meaning of this Directive, other than the first Member State
materials that have undergone all necessary checking and sorting and been obtained through recycling processes and can substitute primary raw materials
temporary employment of staff by a beneficiary with the right for the staff to return to the previous employer; Definitions for aid for disadvantaged workers and for workers with disabilities
the physical or virtual environment and organisational means to ensure compliance with Union law, such as Regulation (EU) 2016/679, in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms
any transaction giving rise to an exposure secured by collateral which does not include a provision conferring upon the institution the right to receive margin at least daily
a liability where the right of the creditor to payment or other form of performance is secured by a charge, pledge or lien, or collateral arrangements including liabilities arising from repurchase transactions and other title transfer collateral arrangements
transferable securities as defined in point (44) of Article 4(1) of Directive 2014/65/EU with the exception of money market instruments as defined in point (17) of Article 4(1) of Directive 2014/65/EU, having a maturity of less than 12 months
transferable securities as defined in Article 4(1), point 18, of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (10) with the exception of money-market instruments, as defined in Article 4(1), point 19, of that Directive having a maturity of less than 12 months, for which national legislation may be applicable
an instance of stock lending or stock borrowing or the lending or borrowing of other financial instruments, a repurchase or reverse repurchase transaction, or a buy-sell back or sell-buy back transaction.
debt securities of the same issuer on tap or at least two separate issues of securities of a similar type and/or class. 2. For the purposes of the definition of ‘controlled undertaking’ in paragraph 1(f)(ii), the holder's rights in relation to voting, appointment and removal shall include the rights of any other undertaking controlled by the shareholder and those of any natural person or legal entity acting, albeit in its own name, on behalf of the shareholder or of any other undertaking controlled by the shareholder. 3. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures concerning the definitions set out in paragraph 1. The Commission shall, in particular:
a system under the first, second and third indents of point (a) of Article 2 of Directive 98/26/EC that is not operated by a central counterparty whose activity consists of the execution of transfer orders
a transaction or scheme, whereby the credit risk associated with an exposure or pool of exposures is tranched, having both of the following characteristics:
a transaction or scheme, whereby the credit risk associated with an exposure or a pool of exposures is tranched, having all of the following characteristics:
a legal person that centrally collects and maintains the records of securitisations. For the purpose of Article 10 of this Regulation, references in Articles 61, 64, 65, 66, 73, 78, 79 and 80 of Regulation (EU) No 648/2012 to ‘trade repository’ shall be construed as references to ‘securitisation repository’.
a security financial collateral arrangement as defined in point (c) of Article 2(1) of Directive 2002/47/EC concluded between counterparties to secure any obligation
an arrangement under which a collateral provider provides financial collateral by way of security in favour of, or to, a collateral taker, and where the full ownership of the financial collateral remains with the collateral provider when the security right is established
the ability of an electricity system to guarantee the supply of electricity to customers with a clearly established level of performance, as determined by the Member States concerned
security of network and information systems 3 definitions
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
the ability of network and information systems to resist, at a given level of confidence, any event that may compromise the availability, authenticity, integrity or confidentiality of stored, transmitted or processed data or of the services offered by, or accessible via, those network and information systems
the ability of electronic communications networks and services to resist, at a given level of confidence, any action that compromises the availability, authenticity, integrity or confidentiality of those networks and services, of stored or transmitted or processed data, or of the related services offered by, or accessible via, those electronic communications networks or services
the actions performed by a credit institution issuing covered bonds to identify cover assets and put them legally beyond the reach of creditors other than covered bond investors and counterparties of derivative contracts
a credit institution, a financial institution, or a group of credit institutions or financial institutions at the highest level of consolidation in the Union in accordance with applicable accounting standards, which is under direct supervision by the Authority pursuant to Article 13
fishing with fishing methods or fishing gears that target and capture organisms by size or species during the fishing operation, allowing non-target specimens to be avoided or released unharmed
a vehicle concept that is based on an inherent unstable equilibrium and that needs an auxiliary control system to maintain its balance, and which includes powered one-wheel vehicles or powered two-wheel, two-track vehicles
a complete factory-made system which is in a suitable frame or casing, is fabricated and transported complete or in two or more sections, can contain isolation valves and in which no gas-containing parts are connected on site
a document in a harmonised form, as set out in Annex I, in which producers, which can be represented by an authorised representative, indicate on their sole responsibility that the product is compliant with the corresponding product specification and that all necessary controls and checks for the proper determination of conformity have been carried out in order to demonstrate the lawful use of the geographical indication to the competent authorities of Member States
a scheduling and dispatching model where the generation schedules and consumption schedules as well as dispatching of power-generating facilities and demand facilities are determined by the scheduling agents of those facilities
a body that represents members of a profession and has a role in regulating them, in performing certain supervisory or monitoring functions and in ensuring the enforcement of the rules relating to them
a body that represents members of a profession and has a role in regulating them, in performing certain supervisory or monitoring type functions and in ensuring the enforcement of the rules relating to them
the performance of tests in its own facilities, the registration of the test results and the submission of a report, including conclusions, to the approval authority by a manufacturer who has been designated as technical service in order to assess the compliance with certain requirements
the performance of tests in its own facilities, the registration of the test results and the submission of a report, including conclusions, to the approval authority by a manufacturer that has been designated as a technical service in order to assess compliance with certain requirements
any natural person or any legal person, irrespective of whether privately or publicly owned, that is acting, including through any other person acting in that natural or legal person's name or on that person's behalf, for purposes relating to that person's trade, business, craft or profession, in relation to contracts covered by this Directive
a trailer in which the axle, or axles are positioned behind the centre of gravity of the vehicle (when uniformly loaded), and which is equipped with a connecting device permitting horizontal and vertical forces to be transmitted to the towing vehicle
any of the stages of production and processing of semiconductor wafers, including substrate materials, front-end and back-end, necessary to deliver a finished semiconductor product
the system of activities, organisations, actors, technology, information, resources and services involved in the production of semiconductors, including raw and processed materials, such as gases, manufacturing equipment, design, including related software development, fabrication, assembly, testing and packaging
the set of activities in relation to a semiconductor product from its conception to its end use, including raw and processed materials, such as gases, manufacturing equipment, research, development and innovation, design, including related software development, fabrication, testing, assembly and packaging to embedding and integration in end products, as well as end-of-life processes, such as reuse, disassembly and recycling
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
the members of the management body in its management function, as well as officers and employees with sufficient knowledge of the obliged entity’s money laundering and terrorist financing risk exposure and sufficient seniority to take decisions affecting its risk exposure
those natural persons who exercise executive functions within an institution and who are responsible, and accountable to the management body, for the day-to-day management of the institution
those natural persons who exercise executive functions within a CSD and who are responsible and accountable to the management body for the day-to-day management of that CSD. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 67 concerning measures to further specify the non-banking-type ancillary services set out in points (1) to (4) of Section B of the Annex and the banking-type ancillary services set out in Section C of the Annex.
the person or persons who effectively direct the business of the credit rating agency and the member or members of its administrative or supervisory board
an officer or employee with sufficient knowledge of the institution's money laundering and terrorist financing risk exposure and sufficient seniority to take decisions affecting its risk exposure, and need not, in all cases, be a member of the board of directors
natural persons who exercise executive functions within an investment firm, a market operator or a data reporting services provider and who are responsible, and accountable to the management body, for the day-to-day management of the entity, including for the implementation of the policies concerning the distribution of services and products to clients by the firm and its personnel
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
non-classified information within the meaning of Article 9 of Commission Decision (EU, Euratom) 2015/443 (37), under which an obligation to protect sensitive non-classified information applies solely to the Commission and to Union agencies and bodies obliged by law to apply the security rules of the Commission
operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings
data, including personalised security credentials which can be used to carry out fraud. For the activities of payment initiation service providers and account information service providers, the name of the account owner and the account number do not constitute sensitive payment data
an investigation of a model algorithm or an assumption to quantify how sensitive or stable the model output data are in relation to variations in the input data or underlying assumptions. It is carried out by varying input values or model equations and by observing how the model output varies correspondingly
a packaging component, whether or not from the same material as the main body of the packaging unit, that is distinct from the main body of the packaging unit, that needs to be disassembled completely and permanently from the main body of the packaging unit and that is typically discarded prior to and separately from the main body of the packaging unit, including packaging components that can be separated from each other simply through mechanical stress during transportation or sorting
a device subject to the requirements of this Regulation or any of the delegated or implementing acts adopted pursuant to this Regulation and intended to be part of a vehicle, which may be type-approved separately but only in relation to one or more specified types of vehicle, where such acts make express provision for so doing
a device subject to the requirements of this Regulation or any of the delegated or implementing acts adopted pursuant to this Regulation and intended to be part of a vehicle, which may be type-approved separately, but only in relation to one or more specified types of vehicle, where those acts make express provision for so doing
a device that is intended to be part of a vehicle that can be type-approved separately, but only in relation to one or more specified types of vehicle and that is subject to the requirements of this Regulation or any of the regulatory acts listed in Annex II where the specific regulatory act makes express provisions to that effect
separate technical unit type-approval 3 definitions
a type-approval whereby an approval authority certifies that a separate technical unit satisfies the relevant administrative provisions and technical requirements in relation to one or more specified types of vehicles
a type-approval whereby an approval authority certifies that a separate technical unit satisfies the relevant administrative provisions and technical requirements in relation to one or more specified types of vehicles
the procedure whereby an approval authority certifies that a type of separate technical unit satisfies the relevant administrative provisions and technical requirements in relation to one or more specified types of vehicles
any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death
an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years
an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years
a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin, as referred to in Article 2(1), 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
serious deficiencies in the proper functioning of the governance systems
the existence of a systemic weakness, taking into account its recurrence, gravity and compromising effect on the correct declaration of expenditure, the reporting on performance, or the respect of Union law
a deficiency in the effective functioning of the management and control system of a programme for which significant improvements in the management and control systems are required and where any of the key requirements 2, 4, 5, 9, 12, 13 and 15 referred to in Annex XI, or two or more of the other key requirements are assessed into categories 3 and 4 of that Annex
serious deficiency in the effective functioning of a management and control system
for the purposes of implementation of the Funds and the EMFF under Part Four, a deficiency for which substantial improvements in the system are required, which exposes the Funds and the EMFF to a significant risk of irregularities, and the existence of which is incompatible with an unqualified audit opinion on the functioning of the management and control system.
an infringement that is defined as such in relevant Union law, including in Article 42(1) of Council Regulation (EC) No 1005/2008 (21) and in Article 90(1) of Regulation (EC) No 1224/2009
an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
a risk which, based on a risk assessment and taking into account the normal and foreseeable use of the product, is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate
an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death
any contract other than a sales contract under which the trader supplies or undertakes to supply a service to the consumer and the consumer pays or undertakes to pay the price thereof
any contract other than a sales contract under which the trader supplies or undertakes to supply a service to the consumer and the consumer pays or undertakes to pay the price thereof
the installation, including ground area, building and equipment, which has been specially arranged, as a whole or in part, to allow the supply of one or more services referred to in points 2 to 4 of Annex II
any natural or legal person that provides one or more of the following categories of services, with the exception of financial services as referred to in Article 2(2), point (b), of Directive 2006/123/EC of the European Parliament and of the Council (30):
an entity that manages a pool of purchased receivables or the underlying credit exposures on a day-to-day basis. 2. For the purposes of point (4)(b) of paragraph 1 of this Article, the Commission may adopt, by way of implementing acts, and subject to the examination procedure referred to in Article 464(2), a decision as to whether a third country applies supervisory and regulatory arrangements at least equivalent to those applied in the Union. In the absence of such a decision, until 1 January 2015, institutions may continue to apply the treatment set out in this paragraph to a third country where the relevant competent authorities had approved the third country as eligible for this treatment before 1 January 2014.
a contract for pecuniary interest concluded in writing by means of which one or more contracting authorities or contracting entities entrust the provision and the management of services other than the execution of works referred to in point (a) to one or more economic operators, the consideration of which consists either solely in the right to exploit the services that are the subject of the contract or in that right together with payment. The award of a works or services concession shall involve the transfer to the concessionaire of an operating risk in exploiting those works or services encompassing demand or supply risk or both. The concessionaire shall be deemed to assume operating risk where, under normal operating conditions, it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject-matter of the concession. The part of the risk transferred to the concessionaire shall involve real exposure to the vagaries of the market, such that any potential estimated loss incurred by the concessionaire shall not be merely nominal or negligible
services rendered on a fee or contract basis by units mainly engaged in the production of transportable goods, as well as services typically related to the production of such goods
all services related to the opening, operating and closing of a payment account, including payment services and payment transactions falling within the scope of point (g) of Article 3 of Directive 2007/64/EC and overdraft facilities and overrunning
data intermediation services offered by an organisational structure constituted by data subjects, one-person undertakings or SMEs who are members of that structure, having as its main objectives to support its members in the exercise of their rights with respect to certain data, including with regard to making informed choices before they consent to data processing, to exchange views on data processing purposes and conditions that would best represent the interests of its members in relation to their data, and to negotiate terms and conditions for data processing on behalf of its members before giving permission to the processing of non-personal data or before they consent to the processing of personal data
services providing access to audiovisual media services
services transmitted by electronic communications networks which are used to identify, select, receive information on, and view audiovisual media services and any provided features, such as subtitles for the deaf and hard of hearing, audio description, spoken subtitles and sign language interpretation, which result from the implementation of measures to make services accessible as referred to in Article 7 of Directive 2010/13/EU; and includes electronic programme guides (EPGs)
an arrangement under which two or more claims or obligations owed between the institution under resolution and a counterparty can be set off against each other
an arrangement under which two or more claims or obligations owed between the CCP under resolution and a counterparty can be set off against each other
the Strategic Energy Technology Plan as set out in the Commission communication of 15 September 2015, entitled, 'Towards an Integrated Strategic Energy Technology (SET) Plan: Accelerating the European Energy System Transformation'
the completion of a securities transaction where it is concluded with the aim of discharging the obligations of the parties to that transaction through the transfer of cash or securities, or both
the non-occurrence of settlement, or partial settlement of a securities transaction on the intended settlement date, due to a lack of securities or cash and regardless of the underlying cause
any institution, including one authorised in accordance with Directive 2013/36/EU or with Directive 2014/65/EU, which executes transfer orders on behalf of clients or on its own account other than through a securities settlement system
an adverse impact that is especially significant on account of its nature, such as an impact that entails harm to human life, health or liberty, or on account of its scale, scope or irremediable character, taking into account its gravity, including the number of individuals that are or may be affected, the extent to which the environment is or may be damaged or otherwise affected, its irreversibility and the limits on the ability to restore affected individuals or the environment to a situation equivalent to their situation prior to the impact within a reasonable period of time
a chemical formulated for use as a pesticide that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use
the scale, scope or irremediable character of the adverse impact, taking into account the gravity of an adverse impact, including the number of individuals that are or may be affected, the extent to which the environment is or may be damaged or otherwise affected, its irreversibility and the limits on the ability to restore affected individuals or the environment to a situation equivalent to their situation prior to the impact within a reasonable period of time. 2. The Commission is empowered to adopt delegated acts in accordance with Article 34 in order to amend the Annex to this Directive by:
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.
access by two or more users to use the same radio spectrum bands under a defined sharing arrangement, authorised on the basis of a general authorisation, individual rights of use for radio spectrum or a combination thereof, including regulatory approaches such as licensed shared access aiming to facilitate the shared use of a radio spectrum band, subject to a binding agreement of all parties involved, in accordance with sharing rules as included in their rights of use for radio spectrum in order to guarantee to all users predictable and reliable sharing arrangements, and without prejudice to the application of competition law
a credit institution or financial institution, or an institution that carries out activities equivalent to those carried out by credit institutions and financial institutions, incorporated in a jurisdiction in which it has no physical presence, involving meaningful mind and management, and which is unaffiliated with a regulated financial group.
any sale by an MMF of an instrument which the MMF does not own at the time of entering into the agreement to sell, including such sale where, at the time of entering into the agreement to sell, the MMF has borrowed or agreed to borrow the instrument for delivery at settlement, not including:
stays on the territory of the Member States of a duration of no more than 90 days in any 180-day period as referred to in Article 6(1) of Regulation (EU) 2016/399
a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause
a situation where a site or part of its components no longer operates under normal operating conditions and is shut down, and where complete or partial pressure reduction is required before repair or maintenance works can be initiated
a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment
a cyber threat the technical characteristics of which indicate that it could have the potential to result in a major ICT-related incident or a major operational or security payment-related incident
a cyber threat which, based on its technical characteristics, can be assumed to have the potential to have a severe impact on the network and information systems of an entity or the users of the entity’s services by causing considerable material or non-material damage
a cybersecurity risk which, based on its technical characteristics, can be assumed to have a high likelihood of an incident that could lead to a severe negative impact, including by causing considerable material or non-material loss or disruption
an initial or secondary offer of securities that is distinct from ordinary trading both in terms of the amount in value of the securities to be offered and the selling method to be employed
both (a) a significant supervised entity in a euro area Member State; and (b) a significant supervised entity in a participating non-euro area Member State
significant supervised entity in a euro area Member State
a supervised entity established in a euro area Member State which has the status of a significant supervised entity pursuant to an ECB decision based on Article 6(4) or Article 6(5)(b) of the SSM Regulation
significant supervised entity in a participating non-euro area Member State
a supervised entity established in a participating non-euro area Member State which has the status of a significant supervised entity pursuant to an ECB decision based on Article 6(4) or Article 6(5)(b) of the SSM Regulation
a supervised group which has the status of significant supervised group pursuant to an ECB decision based on Article 6(4) or Article 6(5)(b) of the SSM Regulation
airspace above the territory to which the Treaties apply, as well as any other airspace where Member States apply Regulation (EC) No 551/2004 in accordance with Article 1(3) of that Regulation
a voucher where the place of supply of the goods or services to which the voucher relates, and the VAT due on those goods or services, are known at the time of issue of the voucher
the procedure whereby an approval authority certifies, by means of a single operation, that a type of vehicle, system, component or separate technical unit as a whole satisfies the relevant administrative provisions and technical requirements
a product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived
a measurement which captures a complete overview of all site-level methane emissions, including, for a pipeline network, emissions from segments of such a network, and typically involves the use of sensors mounted on a mobile platform, such as a vehicle, a drone, an aircraft, a boat or a satellite, or the use of other means, such as fixed sensors or continuous point sensor networks
any system that had consumption of less than 3 000 GWh in the year 1996, where more than 5 % of annual consumption is obtained through interconnection with other systems
a financial entity that employs 10 or more persons, but fewer than 50 persons, and has an annual turnover and/or annual balance sheet total that exceeds EUR 2 million, but does not exceed EUR 10 million
any system that had consumption of less than 3 000 GWh in the year 1996, where less than 5 % of annual consumption is obtained through interconnection with other systems
a small isolated system as defined in point 26 of Article 2 of Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity (26)
an entity that is not an SME and that has up to 499 employees where the staff headcount is calculated in accordance with Articles 3 to 6 of Annex to Recommendation 2003/361/EC
an operation in an Interreg programme aimed at the selection and implementation of projects, including people-to-people actions, of limited financial volume
low-power wireless network access equipment of a small size operating within a small range, using licenced radio spectrum or licence-exempt radio spectrum or a combination thereof, which may be used as part of a public electronic communications network, which may be equipped with one or more low visual impact antennae, and which allows wireless access by users to electronic communications networks regardless of the underlying network topology, be it mobile or fixed
a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering
an electricity network that can integrate in a cost efficient manner the behaviour and actions of all users connected to it, including generators, consumers and those that both generate and consume, in order to ensure an economically efficient and sustainable power system with low losses and high levels of quality, security of supply and safety
an electronic system that is capable of measuring electricity fed into the grid or electricity consumed from the grid, providing more information than a conventional meter, and that is capable of transmitting and receiving data for information, monitoring and control purposes, using a form of electronic communication
the national or regional innovation strategies which set priorities in order to build competitive advantage by developing and matching research and innovation own strengths to business needs in order to address emerging opportunities and market developments in a coherent manner, while avoiding duplication and fragmentation of efforts; a smart specialisation strategy may take the form of, or be included in, a national or regional research and innovation (R&I) strategic policy framework
the national or regional innovation strategies which set priorities in order to build competitive advantage by developing and matching R&I own strengths to business needs in order to address emerging opportunities and market developments in a coherent manner, while avoiding duplication and fragmentation of efforts, including those that take the form of, or are included in, a national or regional R&I strategic policy framework, and fulfilling the enabling condition set out in the relevant provisions of the Common Provisions Regulation for 2021-2027
a micro, small or a medium-sized undertaking, irrespective of its legal form, that is not part of a large group, as those terms are defined according to Article 3(1), (2), (3) and (7) of Directive 2013/34/EU
a product obtained by fractionation and purification of a condensed smoke yielding primary smoke condensates, primary tar fractions and/or derived smoke flavourings as defined in points (1), (2) and (4) of Article 3 of Regulation (EC) No 2065/2003
a Short Message Service text message, composed principally of alphabetical and/or numerical characters, capable of being sent between mobile and/or fixed numbers assigned in accordance with national numbering plans
a policy intervention that aims to provide an innovative response to social needs, implemented on a small scale and in conditions that enable its impact to be measured, prior to being implemented in other contexts including geographical and sectorial ones, or implemented on a larger scale, if the results prove to be positive
an activity, that is social both as to its ends and its means and in particular an activity which relates to the development and implementation of new ideas concerning products, services, practices and models, that simultaneously meets social needs and creates new social relationships or collaborations between public, civil society or private organisations, thereby benefiting society and boosting its capacity to act
a platform that enables end-users to connect, share, discover and communicate with each other across multiple devices, in particular via chats, posts, videos and recommendations
the top layer of the Earth’s crust situated between the bedrock and the surface, which is composed of mineral particles, organic matter, water, air and living organisms
the top layer of the Earth’s crust situated between the bedrock and the surface. The soil is composed of mineral particles, organic matter, water, air and living organisms
production in living soil or in soil that is mixed or fertilised with materials and products that are allowed in organic production in connection with the subsoil and bedrock
any natural or legal person who is a professional client by virtue of point (1), (2), (3) or (4) of Section I of Annex II to Directive 2014/65/EU or any natural or legal person who has the approval of the crowdfunding service provider to be treated as a sophisticated investor in accordance with the criteria and the procedure laid down in Annex II to this Regulation
a component or a geological structure that releases methane into the atmosphere whether intentionally or unintentionally, intermittently or persistently
the currently installed version of the software of a product within the scope of this Regulation, written in a programming language so that it is unambiguous and understandable to humans
material of vegetable, animal, microbiological or mineral origin from which flavourings or food ingredients with flavouring properties are produced; it may be:
the geographically defined area from which the forest biomass feedstock is sourced, from which reliable and independent information is available and where conditions are sufficiently homogeneous to evaluate the risk of the sustainability and legality characteristics of the forest biomass
any space object including spacecraft or fragments and elements thereof in Earth’s orbit or re-entering Earth’s atmosphere, that are non-functional or no longer serve any specific purpose, including parts of rockets or artificial satellites, or inactive artificial satellites
an orbiting object designed to perform a specific function or mission, such as communications, navigation or Earth observation, including satellites, launcher upper stages, and a re-entry vehicle; a spacecraft that can no longer fulfil its intended mission is considered non-functional; spacecraft in reserve or standby modes awaiting possible reactivation are considered functional
a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part
goods which are to be installed in or on a vehicle so as to replace original parts of that vehicle, including goods such as lubricants which are necessary for the use of a vehicle, with the exception of fuel
goods which are to be installed in or on a vehicle so as to replace original parts of that vehicle, including goods such as lubricants which are necessary for the use of a vehicle, with the exception of fuel
goods that are to be installed in or on a vehicle to replace original parts of that vehicle, including goods that are necessary for the use of a vehicle, with the exception of fuel
an estimate of the mass of the fish of a particular stock that reproduces at a defined time, including both males and females and fish that reproduce viviparously
the person or entity appointed to administrate a covered bond programme in the event of the insolvency of a credit institution issuing covered bonds under that programme, or when such credit institution has been determined to be failing or likely to fail pursuant to Article 32(1) of Directive 2014/59/EU or, in exceptional circumstances, where the relevant competent authority determines that the proper functioning of that credit institution is seriously at risk
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.
the categories of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725
any undertaking, whether incorporated or not, other than an existing insurance or reinsurance undertaking, which assumes risks from insurance or reinsurance undertakings and which fully funds its exposure to such risks through the proceeds of a debt issuance or some other financing mechanism where the repayment rights of the providers of such debt or other financing mechanism are subordinated to the reinsurance obligations of such a vehicle
any undertaking, whether incorporated or not, other than an existing insurance or reinsurance undertaking, which assumes risks from insurance or reinsurance undertakings and which fully funds its exposure to such risks through the proceeds of a debt issuance or any other financing mechanism where the repayment rights of the providers of such debt or financing mechanism are subordinated to the reinsurance obligations of such an undertaking
a vehicle of category M, N or O having specific technical features that enable it to perform a function that requires special arrangements or equipment
a right granted by a competent authority of a Member State by means of any law, regulation or published administrative provision which is compatible with the Treaties the effect of which is to limit the exercise of an activity to two or more economic operators and which substantially affects the ability of other economic operators to carry out such an activity
any social security scheme which is different from the general social security scheme applicable to employed persons in the Member State concerned and to which all, or certain categories of, civil servants are directly subject
a credit institution which funds loans solely or mainly through the issue of covered bonds, which is permitted by law only to carry out mortgage and public sector lending and which is not permitted to take deposits, but which takes other repayable funds from the public
the CO2 emissions of a passenger car or a light commercial vehicle measured in accordance with Regulation (EC) No 715/2007 and its implementing Regulations and specified as the CO2 mass emissions (combined) in the certificate of conformity of the vehicle. For passenger cars or light commercial vehicles which are not type-approved in accordance with Regulation (EC) No 715/2007, ‘specific emissions of CO2’ means the CO2 emissions measured pursuant to Regulation (EC) No 715/2007, notably in accordance with the same measurement procedure as specified in Regulation (EC) No 692/2008 until 31 December 2020, and from 1 January 2021 in Regulation (EU) 2017/1151, or in accordance with procedures adopted by the Commission to establish the CO2 emissions for such vehicles
in relation to a manufacturer, the annual target determined in accordance with Annex I or, if the manufacturer is granted a derogation in accordance with Article 10, the specific emissions target determined according to that derogation
the result to which an investment priority or Union priority contributes in a specific national or regional context through actions or measures undertaken within such a priority
a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination
loans for the purposes of the acquisition of or development or construction on land in relation to immovable property, or of and in relation to such property, with the intention of reselling for profit
a system consisting of a number of refrigerant piped units that form a separate but interconnected unit, requiring the installation and connection of refrigerant circuit components at the point of use
an institution other than an originator institution that establishes and manages an asset-backed commercial paper programme or other securitisation scheme that purchases exposures from third-party entities
an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial
any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study
any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation
any legal or natural person, established in the Community, seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product
a credit institution, whether located in the Union or not, as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013, or an investment firm as defined in point (1) of Article 4(1) of Directive 2014/65/EU other than an originator, that:
any undertaking or other body, regardless of whether it includes or consists of one or more legal or natural persons, which acts as an employer or in a self-employed capacity or any combination thereof and which offers a pension scheme or pays contributions to an IORP
a contract for the supply of a commodity traded on a spot market which is promptly delivered when the transaction is settled, and a contract for the supply of a commodity that is not a financial instrument, including a physically settled forward contract
a commodity market in which commodities are sold for cash and promptly delivered when the transaction is settled, and other non-financial markets, such as forward markets for commodities
physical parameters of space objects, including space debris, acquired by SST sensors, or orbital parameters of space objects derived from SST sensors’ observations in the framework of the SST sub-component
a device or a combination of devices, such as ground-based or space-based radars, lasers and telescopes, which is able to perform space surveillance or tracking and that can measure physical parameters related to space objects, such as size, location and velocity
a purchase or offer to purchase securities, or a transaction in associated instruments equivalent thereto, which is undertaken by a credit institution or an investment firm in the context of a significant distribution of such securities exclusively for supporting the market price of those securities for a predetermined period of time, due to a selling pressure in such securities.
the personnel at the central level who supports the College, the Permanent Chambers, the European Chief Prosecutor, the European Prosecutors, the European Delegated Prosecutors and the Administrative Director in the day-to-day activities in the performance of the tasks of this Office under this Regulation
any stage from the primary production of an organic product through its storage, processing, transport, and sale or supply to the final consumer, including, where relevant, labelling, advertising, import, export and subcontracting activities
stages of production, preparation and distribution
any stage from and including the primary production of an organic product up to and including its storage, processing, transport, sale or supply to the final consumer, and where relevant labelling, advertising, import, export and subcontracting activities
an acquisition of securities in a company which does not trigger a legal or regulatory obligation to make an announcement of a takeover bid in relation to that company
the company’s employees, the employees of its subsidiaries, trade unions and workers’ representatives, consumers and other individuals, groupings, communities or entities whose rights or interests are or could be affected by the products, services and operations of the company, its subsidiaries and its business partners, including the employees of the company’s business partners and their trade unions and workers’ representatives, national human rights and environmental institutions, civil society organisations whose purposes include the protection of the environment, and the legitimate representatives of those individuals, groupings, communities or entities
a technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory, and which is one of the following:
standard as defined in Article 1(6) of 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 (16).
projects, other than strategic integrated projects, strategic nature projects or technical assistance projects, that pursue the specific objectives of the LIFE Programme
a CSD link whereby a CSD becomes a participant in the securities settlement system of another CSD under the same terms and conditions as applicable to any other participant in the securities settlement system operated by the latter
an MMF that invests in eligible money market instruments referred to in Article 10(1) and (2) and is subject to the portfolio rules set out in Article 25
an instruction given by the payer to the payment service provider which holds the payer’s payment account to execute credit transfers at regular intervals or on predetermined dates
crops comprising mainly cereals, regardless of whether the grains alone or the whole plant, such as in the case of green maize, are used; tubers and root crops, such as potatoes, Jerusalem artichokes, sweet potatoes, cassava and yams; and corm crops, such as taro and cocoyam
the earlier of either the start of construction works relating to the investment, or the first legally binding commitment to order equipment or any other commitment that makes the investment irreversible. Buying land and preparatory works such as obtaining permits and conducting feasibility studies are not considered start of works. For take-overs, ‘start of works’ means the moment of acquiring the assets directly linked to the acquired establishment
operations excluding regularly oscillating activity phases whilst bringing an activity, an equipment item or a tank into or out of service or into or out of an idling state.
aid falling under Article 107(1) TFEU which shall be deemed for the purposes of this Regulation also to include de minimis aid within the meaning of Commission Regulation (EC) No 1998/2006 ( 23 ) , Commission Regulation (EC) No 1535/2007 ( 24 ) and Commission Regulation (EC) No 875/2007 ( 25 )
a process in which the re-use of a waste product to manufacture an end product is economically profitable normal practice. Where appropriate, the concept of state of the art must be interpreted from a Union technological and internal market perspective
an organisational entity in a Member State, which has been made responsible for the management of one or more railway stations and which may be the infrastructure manager
an industrial battery with internal storage that is specifically designed to store from and deliver electric energy to the grid or store for and deliver electric energy to end-users, regardless of where and by whom the battery is being used
a minimum wage set by law or other binding legal provisions, with the exclusion of minimum wages set by collective agreements that have been declared universally applicable without any discretion of the declaring authority as to the content of the applicable provisions
the procedure consisting of the step-by-step collection of the whole set of EU type-approval certificates or UN type-approval certificates for the systems, components and separate technical units forming part of a vehicle, and which leads, in its final stage, to the whole-vehicle type-approval
a stock with a high probability that its estimated spawning biomass at the end of the previous year is higher than the limit biomass reference point (Blim) and its estimated fishing mortality rate for the previous year is less than the limit fishing mortality rate reference point (Flim)
any combination of space, injectability and deliverability. 2. Without prejudice to the definitions in paragraph 1 of this Article, the definitions contained in Article 2 of Directive 2009/73/EC, which are relevant for the application of this Regulation, also apply, with the exception of the definition of transmission in point 3 of that Article. The definitions in points 3 to 23 of paragraph 1 of this Article in relation to transmission apply by analogy in relation to storage and LNG facilities.
a facility used for the stocking of natural gas and owned and/or operated by a natural gas undertaking, including the part of LNG facilities used for storage but excluding the portion used for production operations, and excluding facilities reserved exclusively for transmission system operators in carrying out their functions
all methods and techniques by which information is collected, stored, processed and assessed with the aim of supporting and developing a criminal policy that contributes to the efficient and effective prevention of, and the fight against, crime
projects that implement, on a regional, multi-regional, national or transnational scale, environmental or climate strategies or action plans developed by Member States' authorities and required by specific environmental, climate or relevant energy legislation or policy of the Union, while ensuring that stakeholders are involved and promoting coordination with and mobilisation of at least one other Union, national or private funding source
projects that support the achievement of Union nature and biodiversity objectives by implementing coherent programmes of action in Member States in order to mainstream those objectives and priorities into other policies and financing instruments, including through coordinated implementation of the prioritized action frameworks adopted pursuant to Directive 92/43/EEC
a commitment between the Union and a third country or an overseas country or territory to increase cooperation related to the raw materials value chain that is established through a non-binding instrument setting out actions of mutual interest, which facilitate beneficial outcomes for both the Union and the relevant third country or overseas countries or territories
an implementing act laying out a strategy for realising content in the work programme covering a maximum period of four years, follows a broad mandatory multi-stakeholder consultation process and specifies the priorities, suitable types of action and forms of implementation to be used
a quantity of a particular raw material in whichever form that is stored by a public or private operator with a view to releasing it in the event of a supply disruption
the content of active substances in a veterinary medicinal product, expressed quantitatively per dosage unit, per unit of volume or per unit of weight according to the pharmaceutical form
a sudden or severe deterioration in the solvency or liquidity position of a credit institution due to changes in market conditions or idiosyncratic factors as a result of which there may be a significant risk that the credit institution becomes unable to meet its commitments as they fall due within the next 30 calendar days
an authentication based on the use of two or more elements categorised as knowledge (something only the user knows), possession (something only the user possesses) and inherence (something the user is) that are independent, in that the breach of one does not compromise the reliability of the others, and is designed in such a way as to protect the confidentiality of the authentication data
congestion in the transmission system that is capable of being unambiguously defined, is predictable, is geographically stable over time, and frequently reoccurs under normal electricity system conditions
a structured deposit as defined in Article 4(1), point (43), of Directive 2014/65/EU. 2. The Commission shall adopt delegated acts in accordance with Article 139 to supplement this Regulation by further specifying technical elements of the definitions laid down in paragraph 1 of this Article, and to adjust those definitions to market developments and technological developments.
a deposit as defined in point (c) of Article 2(1) of Directive 2014/49/EU of the European Parliament and of the Council (46), which is fully repayable at maturity on terms under which interest or a premium will be paid or is at risk, according to a formula involving factors such as:
those securities created to securitise and transfer credit risk associated with a pool of financial assets entitling the security holder to receive regular payments that depend on the cash flow from the underlying assets
activities needed to prepare project implementation, such as preparatory, feasibility, evaluation, testing and validation studies, including software, and any other technical support measure including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package
any intentionally induced process which causes loss of consciousness and sensibility without pain, including any process resulting in instantaneous death
a national section which is opened within each PEPP account and which corresponds to the legal requirements and conditions for using possible incentives fixed at national level for investing in a PEPP by the Member State of the PEPP saver’s residence; accordingly, an individual may be a PEPP saver or a PEPP beneficiary in each sub-account, depending on the respective legal requirements for the accumulation phase and decumulation phase
on the basis of the consolidated situation of a parent institution, financial holding company or mixed financial holding company, excluding a sub-group of entities, or on the basis of the consolidated situation of a parent institution, financial holding company or mixed financial holding company that is not the ultimate parent institution, financial holding company or mixed financial holding company
an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes
any consumer who, on the basis of a contract for the provision of an online content service with a provider whether against payment of money or without such payment, is entitled to access and use such service in the Member State of residence
any natural person or legal entity who or which is party to a contract with the provider of publicly available electronic communications services for the supply of such services
a legal person through which the activity of a controlled undertaking within the meaning of Article 2(1), point (f), of Directive 2004/109/EC of the European Parliament and of the Council (44) is exercised
a legal person, as defined in Article 2, point (10), of Directive 2013/34/EU, and a legal person through which the activity of a controlled undertaking, as defined in Article 2(1), point (f), of Directive 2004/109/EC of the European Parliament and of the Council (46), is exercised
a subsidiary undertaking as described in Articles 1 and 2 of Directive 83/349/EEC, including a subsidiary of a subsidiary undertaking of an ultimate parent undertaking
a subsidiary undertaking as defined in point (10) of Article 2 and within the meaning of Article 22 of Directive 2013/34/EU, including any subsidiary of a subsidiary undertaking of an ultimate parent undertaking
a subsidiary undertaking within the meaning of Articles 2(10) and 22 of Directive 2013/34/EU, including any subsidiary of a subsidiary undertaking of an ultimate parent undertaking
a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition
any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect. Such a substance would, unless there are other grounds for concern, normally be: — a substance classified as dangerous or that meets the criteria to be classified as dangerous according to Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or — a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation, — a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006
a change in the nature or functioning, or an extension, of an installation or combustion plant, waste incineration plant or waste co-incineration plant which may have significant negative effects on human health or the environment
the connection of a hosting service provider with one or more Member States resulting either from its establishment in the Union or from specific factual criteria, such as:
a connection of a provider of intermediary services with the Union resulting either from its establishment in the Union or from specific factual criteria, such as: — a significant number of recipients of the service in one or more Member States in relation to its or their population; or — the targeting of activities towards one or more Member States
a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed
any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial
a change to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements has been assessed
a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new hazard, or by increasing an existing risk, which requires:
a duly reasoned claim based on objective and verifiable information regarding non-compliance with this Regulation and which could require the intervention of competent authorities
the quality of a habitat of a species which allows the ecological requirements of a species to be met at any stage of its biological cycle so that it is maintaining itself on a long-term basis as a viable component of its habitat in its natural range, contributing to reaching or maintaining favourable conservation status for a species listed in Annex II, IV or V to Directive 92/43/EEC and securing populations of wild bird species covered by Directive 2009/147/EC and, in addition, in marine ecosystems, contributing to achieving or maintaining good environmental status
the quantity of a habitat of a species which allows the ecological requirements of a species to be met at any stage of its biological cycle so that it is maintaining itself on a long-term basis as a viable component of its habitat in its natural range, contributing to reaching or maintaining favourable conservation status for a species listed in Annex II, IV or V to Directive 92/43/EEC and securing populations of wild bird species covered by Directive 2009/147/EC and, in addition, in marine ecosystems, contributing to achieving or maintaining good environmental status
the body entrusted with responsibilities aimed at ensuring compliance by obliged entities with the requirements of this Regulation, including AMLA when performing the tasks entrusted to it in Article 5(2) of Regulation (EU) 2024/1620
the supervisory authority established in accordance with Article 51(1) of Regulation (EU) 2016/679 and the supervisory authority established in accordance with Article 41(1) of Directive (EU) 2016/680
a supervisor who is a public body, or the public authority overseeing self-regulatory bodies in their performance of supervisory functions pursuant to Article 37 of Directive (EU) 2024/1640, or AMLA when acting as a supervisor
an independent public authority which is established by a Member State of the European Union pursuant to Article 51 of Regulation (EU) 2016/679 of the European Parliament and of the Council (19) or pursuant to Article 41 of Directive (EU) 2016/680
any natural or legal person, public or private, who, acting in his commercial or professional capacity, is the contractual provider of services subject to distance contracts
a manufacturer established in the Union, the authorised representative of a manufacturer who is not established in the Union, or an importer, who places a product on the Union market
the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer
the obligations of Union importers of tin, tantalum and tungsten, their ores, and gold in relation to their management systems, risk management, independent third-party audits and disclosure of information with a view to identifying and addressing actual and potential risks linked to conflict-affected and high-risk areas to prevent or mitigate adverse impacts associated with their sourcing activities
contracts having as their object the purchase, lease, rental or hire-purchase, with or without an option to buy, of products. A supply contract may include, as an incidental matter, siting and installation operations
the unexpected significant decrease in the availability of a raw material or significant increase in the price of a raw material beyond normal market price volatility
contracts for pecuniary interest concluded in writing between one or more contracting entities and one or more economic operators and having as their object the execution of works, the supply of products or the provision of services
the period during which a manufacturer is required to ensure that vulnerabilities of a product with digital elements are handled effectively and in accordance with the essential cybersecurity requirements set out in Part II of Annex I
the rate of public expenditure to an operation; in the context of financial instruments it refers to the gross grant equivalent of the support as defined in Article 2, point (20), of Commission Regulation (EU) No 702/2014 ( 34 )
any instrument, scheme or mechanism applied by a Member State, or a group of Member States, that promotes the use of energy from renewable sources by reducing the cost of that energy, increasing the price at which it can be sold, or increasing, by means of a renewable energy obligation or otherwise, the volume of such energy purchased, including but not restricted to, investment aid, tax exemptions or reductions, tax refunds, renewable energy obligation support schemes including those using green certificates, and direct price support schemes including feed-in tariffs and sliding or fixed premium payments
the provision of office space, websites, data banks, libraries, market research, handbooks, working and model documents; Definitions for Aid for access to finance for SMEs
any required document issued by a partner competent authority or drawn up by an economic operator, or any required information provided by an economic operator, to certify that Union non-customs formalities have been fulfilled
that part of the allowable catch which a coastal State does not harvest, resulting in an overall exploitation rate for individual stocks that remains below levels at which stocks are capable of restoring themselves and maintaining populations of harvested species above desired levels based on the best available scientific advice
offsetting of CBAM certificates against the declared embedded emissions in imported goods or against the embedded emissions in imported goods that should have been declared
a periodic routine on-site assessment that is neither the on-site assessment undertaken for the initial designation of the technical service or of one of its subcontractors or subsidiaries, nor the on-site assessment undertaken for the renewal of that designation
a zone which is established around the protection zone, and where disease control measures are applied in order to prevent the spread of the disease from the protection zone
an environmental, social or governance event or condition that, if it occurs, could cause an actual or a potential material negative impact on the value of the investment
a bond whose financial or structural characteristics vary depending on the achievement by the issuer of predefined environmental sustainability objectives
sustainable aviation fuels, synthetic low- carbon aviation fuels or hydrogen for aviation as defined in Article 3, point (7), (13) or (17) of Regulation (EU) 2023/2405 destined for the aviation sector or fuels destined for the maritime sector as identified in accordance with criteria defined in Article 10(1) and (2) of Regulation (EU) 2023/1805
an international agreement concluded with a third state for the purpose of obtaining access to waters and resources in order to sustainably exploit a share of the surplus of marine biological resources, in exchange for financial compensation from the Union, which may include sectoral support. 2. For the purposes of this Regulation, the following geographical definitions of geographical areas shall apply:
an investment in an economic activity that contributes to an environmental objective, as measured, for example, by key resource efficiency indicators on the use of energy, renewable energy, raw materials, water and land, on the production of waste, and greenhouse gas emissions, or on its impact on biodiversity and the circular economy, or an investment in an economic activity that contributes to a social objective, in particular an investment that contributes to tackling inequality or that fosters social cohesion, social integration and labour relations, or an investment in human capital or economically or socially disadvantaged communities, provided that such investments do not significantly harm any of those objectives and that the investee companies follow good governance practices, in particular with respect to sound management structures, employee relations, remuneration of staff and tax compliance
concerted investigations of consumer markets through simultaneous coordinated control actions to check compliance with, or to detect infringements of, Union laws that protect consumers’ interests.
the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data
charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges
upon a PEPP saver’s request, transferring from one PEPP provider to another the corresponding amounts, or where applicable assets-in-kind in accordance with Article 52(4), from one PEPP account to the other, with closing the former PEPP account without prejudice to point (e) of Article 53(4)
a charge or penalty for changing suppliers or market participants engaged in aggregation, including contract termination fees, that is directly or indirectly imposed on customers by suppliers, market participants engaged in aggregation or system operators
an investment by an institution in a financial instrument the value of which is directly linked to the value of the capital instruments issued by a financial sector entity
a securitisation where the transfer of risk is achieved by the use of credit derivatives or guarantees, and the exposures being securitised remain exposures of the originator institution
a securitisation where the transfer of risk is achieved by the use of credit derivatives or guarantees, and the exposures being securitised remain exposures of the originator
an assembly of devices combined to perform one or more specific functions in a vehicle and which is subject to the requirements of this Regulation or any of the delegated or implementing acts adopted pursuant to this Regulation
a combination of several goods which when put together perform a specific function in an expected environment and of which the energy efficiency can then be determined as a single entity
any transmission networks, distribution networks, LNG facilities and/or storage facilities owned and/or operated by a natural gas undertaking, including linepack and its facilities supplying ancillary services and those of related undertakings necessary for providing access to transmission, distribution and LNG
an assembly of devices combined to perform one or more specific functions in a vehicle and which is subject to the requirements of this Regulation or any of the delegated or implementing acts adopted pursuant to this Regulation
an assembly of devices combined to perform one or more specific functions in a vehicle and that is subject to the requirements of this Regulation or any of the regulatory acts listed in Annex II
system for policies and measures and projections 2 definitions
a system of institutional, legal and procedural arrangements established for reporting policies and measures and projections relating to anthropogenic emissions by sources and removals by sinks of greenhouse gases and to the energy system, inter alia as required by Article 39
a system of institutional, legal and procedural arrangements established for reporting policies and measures and projections of anthropogenic emissions by sources and removals by sinks of greenhouse gases not controlled by the Montreal Protocol as required by Article 12 of this Regulation
system for the identification and registration of animals
the system for the identification and registration of kept terrestrial animals laid down by Part IV, Title I, Chapter 2, Section 1, of Regulation (EU) 2016/429 of the European Parliament and of the Council ( 31 )
any situation in respect of a transmission network including necessary transmission facilities in which the pressure and the quality of the natural gas remain within the minimum and maximum limits laid down by the transmission system operator, so that the transmission of natural gas is guaranteed from a technical standpoint
a type-approval whereby an approval authority certifies that a system built into a vehicle of a specific type satisfies the relevant administrative provisions and technical requirements
a type-approval whereby an approval authority certifies that a system built into a vehicle of a specific type satisfies the relevant administrative provisions and technical requirements
the procedure whereby an approval authority certifies that a type of system satisfies the relevant administrative provisions and technical requirements
an investment firm which, on an organised, frequent systematic and substantial basis, deals on own account when executing client orders outside a regulated market, an MTF or an OTF without operating a multilateral system; The frequent and systematic basis shall be measured by the number of OTC trades in the financial instrument carried out by the investment firm on own account when executing client orders. The substantial basis shall be measured either by the size of the OTC trading carried out by the investment firm in relation to the total trading of the investment firm in a specific financial instrument or by the size of the OTC trading carried out by the investment firm in relation to the total trading in the Union in a specific financial instrument. The definition of a systematic internaliser shall apply only where the pre-set limits for a frequent and systematic basis and for a substantial basis are both crossed or where an investment firm chooses to opt-in under the systematic internaliser regime
a disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructure may be potentially systemically important to some degree
any irregularity, which may be of a recurring nature, with a high probability of occurrence in similar types of operations, which results from a serious deficiency in the effective functioning of a management and control system, including a failure to establish appropriate procedures in accordance with this Regulation and the Fund-specific rules
any irregularity, which may be of a recurring nature, with a high probability of occurrence in similar types of operations, which results from a serious deficiency, including a failure to establish appropriate procedures in accordance with this Regulation and the Fund-specific rules
a risk that is specific to the high-impact capabilities of general-purpose AI models, having a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chain
a risk of disruption in the financial system with the potential to have serious negative consequences for the internal market and the real economy. All types of financial intermediaries, markets and infrastructure may be potentially systemically important to some degree.
an EU parent institution, an EU parent financial holding company, an EU parent mixed financial holding company or an institution the failure or malfunction of which could lead to systemic risk