02018R0858 — EN — 06.12.2022 — 003.002

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►B REGULATION (EU) 2018/858 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (Text with EEA relevance) (OJ L 151 14.6.2018, p. 1)

Amended by:





Corrected by:









▼B

REGULATION (EU) 2018/858 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 May 2018

on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC

(Text with EEA relevance)







CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

1. This Regulation lays down the administrative provisions and technical requirements for the type-approval and placing on the market of all new vehicles, systems, components and separate technical units, referred to in Article 2(1), and for individual vehicle approvals.

This Regulation also lays down provisions for the placing on the market and the entry into service of parts and equipment that may pose a serious risk to the correct functioning of the essential systems of the vehicles referred to in Article 2(1).

2. This Regulation lays down the requirements for the market surveillance of vehicles, systems, components and separate technical units that are subject to approval. This Regulation also lays down the requirements for the market surveillance of parts and equipment for such vehicles.

Article 2

Scope

1. This Regulation applies to motor vehicles of categories M and N and their trailers of category O, that are intended to be used on public roads, including those designed and constructed in one or more stages, and to systems, components and separate technical units, as well as to parts and equipment, designed and constructed for such vehicles and their trailers.

2. This Regulation does not apply to the following vehicles: (a) agricultural or forestry vehicles, as defined in Regulation (EU) No 167/2013 of the European Parliament and of the Council ( 1 ); (b) two- or three-wheel vehicles and quadricycles, as defined in Regulation (EU) No 168/2013 of the European Parliament and of the Council ( 2 ); (c) track-laying vehicles; (d) vehicles designed and constructed or adapted for use by the armed services only.

3. For the following vehicles, the manufacturer may apply for type-approval or individual vehicle approval under this Regulation, provided that those vehicles fulfil the requirements of this Regulation: (a) vehicles designed and constructed for use principally on construction sites or in quarries, port or airport facilities; (b) vehicles designed and constructed or adapted for use by civil protection, fire services and forces responsible for maintaining public order; (c) any self-propelled vehicle designed and constructed specifically to perform work and that, because of its construction characteristics, is not suitable for carrying passengers or for transporting goods, and that is not machinery mounted on a motor vehicle chassis.

Such approvals shall be without prejudice to the application of Directive 2006/42/EC of the European Parliament and of the Council ( 3 ).

4. For the following vehicles, the manufacturer may apply for individual vehicle approval under this Regulation: (a) vehicles intended exclusively for racing on roads; (b) prototypes of vehicles used on the road under the responsibility of a manufacturer to perform a specific test programme provided they have been specifically designed and constructed for that purpose.

Article 3

Definitions

For the purposes of this Regulation and the regulatory acts listed in Annex II, except as otherwise provided therein, the following definitions apply:

(1) ‘type-approval’ means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

(2) ‘EU type-approval’ means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements of this Regulation;

(3) ‘national type-approval’ means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements laid down by the law of a Member State, the validity of such approval being restricted to the territory of that Member State;

(4) ‘type-approval certificate’ means the document whereby the approval authority officially certifies that a type of vehicle, system, component or separate technical unit is type-approved;

(5) ‘certificate of conformity’ means the document issued by the manufacturer which certifies that a produced vehicle conforms to the approved type of vehicle and complies with all regulatory acts that were applicable at the time of its production;

(6) ‘individual vehicle approval’ means the procedure whereby an approval authority certifies that a particular vehicle, whether unique or not, satisfies the relevant administrative provisions and technical requirements for EU individual vehicle approval or national individual vehicle approval;

(7) ‘whole-vehicle type-approval’ means the procedure whereby an approval authority certifies that an incomplete, complete or completed type of vehicle satisfies the relevant administrative provisions and technical requirements;

(8) ‘multi-stage type-approval’ means the procedure whereby one or more approval authorities certify that depending on its state of completion, an incomplete or completed type of vehicle satisfies the relevant administrative provisions and technical requirements;

(9) ‘step-by-step type-approval’ means 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;

(10) ‘single-step type-approval’ means 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;

(11) ‘mixed type-approval’ means a step-by-step type-approval for which one or more system type-approvals have been obtained during the final stage of the whole-vehicle type-approval, without the need to issue the EU type-approval certificates for those systems;

(12) ‘system type-approval’ means the procedure whereby an approval authority certifies that a type of system satisfies the relevant administrative provisions and technical requirements;

(13) ‘separate technical unit type-approval’ means 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;

(14) ‘component type-approval’ means the procedure whereby an approval authority certifies that a type of component independently of a vehicle satisfies the relevant administrative provisions and technical requirements;

(15) ‘vehicle’ means any motor vehicle or its trailer;

(16) ‘motor vehicle’ means any power-driven vehicle that is designed and constructed to be moved by its own means, that has at least four wheels, is complete, completed or incomplete, and has a maximum design speed exceeding 25 km/h;

(17) ‘trailer’ means any non-self-propelled vehicle on wheels designed and constructed to be towed by a motor vehicle, that can articulate at least around a horizontal axis perpendicular to the longitudinal median plane and around a vertical axis parallel to the longitudinal median plane of the towing motor vehicle;

(18) ‘system’ means 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;

(19) ‘component’ means a device that is intended to be part of a vehicle, that can be type-approved independently of a 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 provision to that effect;

(20) ‘separate technical unit’ means 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;

(21) ‘parts’ means goods used for the assembly, repair and maintenance of a vehicle, as well as spare parts;

(22) ‘equipment’ means goods other than parts that can be added to or installed on a vehicle;

(23) ‘spare parts’ means 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;

(24) ‘base vehicle’ means any vehicle that is used at the initial stage of a multi-stage type-approval;

(25) ‘incomplete vehicle’ means any vehicle that must undergo at least one further stage of completion in order to meet the relevant technical requirements of this Regulation;

(26) ‘completed vehicle’ means a vehicle resulting from the multi-stage type-approval that meets the relevant technical requirements of this Regulation;

(27) ‘complete vehicle’ means a vehicle that does not need to be completed in order to meet the relevant technical requirements of this Regulation;

(28) ‘end-of-series vehicle’ means a vehicle that is part of a stock and that, due to the entry into force of new technical requirements against which it has not been type-approved, cannot or can no longer be made available on the market, registered or entered into service;

(29) ‘alternative-fuel vehicle’ means a vehicle designed to be capable of running on at least one type of fuel that is either gaseous at atmospheric temperature and pressure, or that is substantially derived from non-mineral oil;

(30) ‘vehicle produced in small series’ means a type of vehicle of which the number of units that are made available on the market, registered or entered into service do not exceed the quantitative annual limits laid down in Annex V;

(31) ‘special purpose vehicle’ means 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;

(32) ‘type of vehicle’ means a particular group of vehicles that shares at least the features specified in Part B of Annex I, including a group of vehicles that contains variants and versions as referred to therein;

(33) ‘semi-trailer’ means a towed vehicle 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;

(34) ‘market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles, systems, components and separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety, the environment or any other aspect of public interest protection;

(35) ‘market surveillance authority’ means the national authority or authorities responsible for carrying out market surveillance on the territory of the Member State;

(36) ‘approval authority’ means the authority or authorities of a Member State, notified to the Commission by that Member State, with competence for all aspects of the type-approval of a vehicle, system, component or separate technical unit, or of the individual vehicle approval, for the authorisation process for parts and equipment, for issuing and, if appropriate, for withdrawing or refusing approval certificates, for acting as the contact point for the approval authorities of the other Member States, for designating the technical services, and for ensuring that the manufacturer meets its obligations regarding the conformity of production;

(37) ‘national authority’ means an approval authority or any other authority involved in and responsible for market surveillance, border control or registration in a Member State in respect of vehicles, systems, components, separate technical units, parts or equipment;

(38) ‘technical service’ means an organisation or body designated by the approval authority as a testing laboratory to carry out tests, or as a conformity assessment body to carry out the initial assessment and other tests or inspections;

(39) ‘national accreditation body’ means a national accreditation body as defined in point (11) of Article 2 of Regulation (EC) No 765/2008;

(40) ‘manufacturer’ means a natural or legal person who is responsible for all aspects of the type-approval of a vehicle, system, component or separate technical unit, or the individual vehicle approval, or the authorisation process for parts and equipment, for ensuring conformity of production and for market surveillance matters regarding that vehicle, system, component, separate technical unit, part and equipment produced, irrespective of whether or not that person is directly involved in all stages of the design and construction of that vehicle, system, component or separate technical unit concerned;

(41) ‘manufacturer's representative’ means any natural or legal person established in the Union who is duly appointed by the manufacturer to represent the manufacturer before the approval authority or the market surveillance authority and to act on the manufacturer's behalf in matters covered by this Regulation;

(42) ‘importer’ means a natural or legal person established in the Union who places on the market a vehicle, system, component, separate technical unit, part or equipment that has been manufactured in a third country;

(43) ‘distributor’ means a dealer or any other natural or legal person in the supply chain, other than the manufacturer or the importer, who makes available on the market a vehicle, system, component, separate technical unit, part or equipment;

(44) ‘economic operator’ means the manufacturer, the manufacturer's representative, the importer or the distributor;

(45) ‘independent operator’ means a natural or legal person, other than an authorised dealer or repairer, who is directly or indirectly involved in the repair and maintenance of vehicles, and include repairers, manufacturers or distributors of repair equipment, tools or spare parts, as well as publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative-fuel vehicles; it also means authorised repairers, dealers and distributors within the distribution system of a given vehicle manufacturer to the extent that they provide repair and maintenance services for vehicles in respect of which they are not members of the vehicle manufacturer's distribution system;

(46) ‘authorised repairer’ means a natural or legal person who provides repair and maintenance services for vehicles and who operates within the manufacturer's distribution system;

(47) ‘independent repairer’ means a natural or legal person who provides repair and maintenance services for vehicles and who does not operate within the manufacturer's distribution system;

(48) ‘vehicle repair and maintenance information’ means all information, including all subsequent amendments and supplements thereto, that is required for diagnosing, servicing and inspecting a vehicle, preparing it for road worthiness testing, repairing, re-programming or re-initialising of a vehicle, or that is required for the remote diagnostic support of a vehicle or for the fitting on a vehicle of parts and equipment, and that is provided by the manufacturer to his authorised partners, dealers and repairers or is used by the manufacturer for the repair and maintenance purposes;

(49) ‘vehicle on-board diagnostic (OBD) information’ means the information generated by a system that is on board a vehicle or that is connected to an engine, and that is capable of detecting a malfunction, and, where applicable, is capable of signalling its occurrence by means of an alert system, is capable of identifying the likely area of malfunction by means of information stored in a computer memory, and is capable of communicating that information off-board;

(50) ‘placing on the market’ means making available a vehicle, system, component, separate technical unit, part or equipment for the first time in the Union;

(51) ‘making available on the market’ means any supply of a vehicle, system, component, separate technical unit, part or equipment for distribution or use on the market in the course of a commercial activity, whether in return for payment or free of charge;

(52) ‘entry into service’ means the first use, for its intended purpose, in the Union, of a vehicle, system, component, separate technical unit, part or equipment;

(53) ‘registration’ means an administrative authorisation for the entry into service in road traffic of an approved vehicle, involving the identification of the vehicle and the issuing to it of a serial number, known as the registration number, whether on a permanent or temporary basis;

(54) ‘virtual testing method’ means computer simulations, including calculations, to demonstrate that a vehicle, a system, a component or a separate technical unit fulfils the technical requirements of a regulatory act listed in Annex II without requiring the use of a physical vehicle, system, component or separate technical unit;

(55) ‘alternative requirements’ means administrative provisions and technical requirements that aim to ensure a level of functional safety, environmental protection and occupational safety that to the greatest extent practicable is equivalent to the level provided for by one or more of the regulatory acts listed in Annex II;

(56) ‘on-site assessment’ means a verification in the premises of a technical service or of one of its subcontractors or subsidiaries;

(57) ‘surveillance on-site assessment’ means 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;

(58) ‘date of manufacture of the vehicle’ means the date on which the manufacture of a vehicle was finalised in accordance with the approval obtained by the manufacturer.

Article 4

Vehicle categories

1. For the purposes of this Regulation, the following vehicle categories shall apply: (a) Category M consists of motor vehicles designed and constructed primarily for the carriage of passengers and their luggage, divided into: (i) Category M1 : motor vehicles with not more than eight seating positions in addition to the driver's seating position and without space for standing passengers, regardless of whether the number of seating positions is restricted to the driver's seating position; (ii) Category M2 : motor vehicles with more than eight seating positions in addition to the driver's seating position and having a maximum mass not exceeding 5 tonnes, regardless of whether those motor vehicles have space for standing passengers; and (iii) Category M3 : motor vehicles with more than eight seating positions in addition to the driver's seating position and having a maximum mass exceeding 5 tonnes, regardless of whether those motor vehicles have space for standing passengers; (b) Category N consists of motor vehicles designed and constructed primarily for the carriage of goods, divided into: (i) Category N1 : motor vehicles with a maximum mass not exceeding 3,5 tonnes; (ii) Category N2 : motor vehicles with a maximum mass exceeding 3,5 tonnes but not exceeding 12 tonnes; and (iii) Category N3 : motor vehicles with a maximum mass exceeding 12 tonnes; (c) Category O consists of trailers, divided into: (i) Category O1 : trailers with a maximum mass not exceeding 0,75 tonnes; (ii) Category O2 : trailers with a maximum mass exceeding 0,75 tonnes but not exceeding 3,5 tonnes; (iii) Category O3 : trailers with a maximum mass exceeding 3,5 tonnes but not exceeding 10 tonnes; and (iv) Category O4 : trailers with a maximum mass exceeding 10 tonnes.

2. The criteria for the categorisation of vehicles, types of vehicle, variants and versions are set out in Annex I.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex I in relation to the types of vehicle and types of bodywork to take account of technical progress.







CHAPTER II

GENERAL OBLIGATIONS

Article 5

Technical requirements

1. Vehicles, systems, components and separate technical units shall comply with the requirements of the regulatory acts listed in Annex II.

2. Vehicles, systems, components and separate technical units shall be considered not to comply with this Regulation in the following cases in particular: (a) if they deviate from the particulars in the EU type-approval certificates and their attachments or from the descriptive particulars in the test reports more than is permitted in the relevant regulatory act; (b) if the performance criteria or limit values for series production laid down in the relevant regulatory act have not been fulfilled under all the conditions set out in the relevant regulatory act; (c) if any information given by the manufacturer in the information document is not reproducible under all the conditions set out in the relevant regulatory act by approval authorities, market surveillance authorities or the Commission.

Only checks, tests, inspections and assessments conducted by or carried out on behalf of the approval authorities, market surveillance authorities or the Commission shall be taken into account when assessing compliance for the purposes of this paragraph.

3. The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex II in order to take into account technological and regulatory developments by introducing and updating references to the regulatory acts that contain the requirements with which vehicles, systems, components and separate technical units have to comply.

Article 6

Obligations of Member States

1. Member States shall establish or appoint their own approval authorities and market surveillance authorities. Member States shall notify the Commission of the establishment and appointment of those authorities.

That notification shall include the name of those authorities, their address, including their electronic address, and their areas of responsibility. The Commission shall publish on its website a list and contact details of the approval authorities and the market surveillance authorities.

Member States shall ensure that their own approval authorities and market surveillance authorities adhere to a strict separation of roles and responsibilities and that they each function independently from each other. Those authorities may be within the same organisation provided that their activities are managed autonomously as part of separate structures.

2. A Member State where more than one approval authority is responsible for vehicle approval including individual vehicle approval shall designate one of them that has the competence for issuing type-approvals as the sole approval authority that is responsible for the exchange of information with the approval authorities of other Member States for the purpose of Article 11 and for the fulfilment of obligations set out in Chapter XV.

3. A Member State where more than one market surveillance authority is responsible for market surveillance shall designate one of them as the sole market surveillance authority that is responsible for the exchange of information with the market surveillance authorities of other Member States for the purpose of Article 11.

4. Member States shall only permit the placing on the market, the registration or the entry into service of vehicles, systems, components and separate technical units that comply with this Regulation.

5. Member States shall not prohibit, restrict or impede the placing on the market, the registration or the entry into service of vehicles, systems, components or separate technical units that comply with this Regulation, except in the cases provided for in Chapter XI.

By way of derogation from the first subparagraph of this paragraph, Member States may decide not to allow the circulation on the road, the placing on the market, the registration or the entry into service of vehicles that have been type-approved in accordance with this Regulation, but that exceed the harmonised dimensions, weights and axle loads laid down in Annex I to Council Directive 96/53/EC ( 4 ).

6. Member States shall organise and carry out market surveillance and controls of vehicles, systems, components and separate technical units entering the market, in accordance with this Regulation and Chapter III of Regulation (EC) No 765/2008.

7. Member States shall take the necessary measures to ensure that market surveillance authorities are entitled, where they consider it necessary and justified, to enter the premises of economic operators on their territory and to take any necessary samples of vehicles, systems, components and separate technical units for the purposes of compliance testing.

8. The Member States shall periodically review and assess the functioning of their type-approval activities. Such reviews and assessments shall be carried out at least every four years, and the results thereof shall be communicated to the Commission and the Forum for Exchange of Information on Enforcement referred to in Article 11 (‘the Forum’).

The Member States shall make accessible to the public a summary of the results of periodic reviews and assessments.

The Member States shall report to the Commission and the Forum on how they address any recommendations referred to in Article 11(5) issued by the Forum.

9. The Member States shall periodically review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the Commission and to the Forum.

The Member States shall make accessible to the public a summary of the results of periodic reviews and assessments.

The Member States shall report to the Commission and the Forum on how they address any recommendations referred to in Article 11(5) issued by the Forum.

10. The Commission may adopt implementing acts laying down the common criteria for the format of reporting on the reviews and assessments referred to in paragraphs 8 and 9 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

Article 7

Obligations of approval authorities

1. Approval authorities shall only approve vehicles, systems, components or separate technical units that comply with this Regulation.

2. Approval authorities shall carry out their duties independently and impartially. They shall observe confidentiality in order to protect commercial secrets, subject to the obligation laid down in Article 9(4) to make information available to the Commission and to other applicable disclosure requirements laid down in Union law in order to protect the interests of users in the Union.

Approval authorities shall cooperate efficiently and effectively, and shall share information relevant to their role and functions.

3. For the purpose of enabling market surveillance authorities to carry out checks, approval authorities shall make available to market surveillance authorities the necessary information related to the type-approval of the vehicles, systems, components and separate technical units that are subject to compliance verification checks. That information shall include at least the information included in the EU type-approval certificate and its attachments referred to in Article 28(1). Approval authorities shall provide that information to the market surveillance authorities without undue delay.

4. Where an approval authority has been informed in accordance with Chapter XI that a vehicle, system, component or separate technical unit is suspected of presenting a serious risk or of being in non-compliance, it shall take all necessary measures to review the type-approval granted and, where appropriate, correct or withdraw the type-approval depending on the reasons and the seriousness of the deviations demonstrated.

Article 8

Obligations of market surveillance authorities

1. Market surveillance authorities shall carry out regular checks to verify that vehicles, systems, components and separate technical units comply with the relevant requirements. Such checks shall be performed on an adequate scale by means of documentary checks and, where appropriate, laboratory tests and on-road tests conducted on the basis of statistically relevant samples.

When carrying out such checks, market surveillance authorities shall take account of:

(a) established principles of risk assessment;

(b) substantiated complaints; and

(c) any other relevant information, including the information exchanged in the Forum and testing results published by recognised third parties that meet the requirements laid down by the implementing acts referred to in Article 13(10).

2. Without prejudice to paragraph 1, the market surveillance authorities of each Member State shall carry out at least a minimum number of tests on vehicles per year. That minimum number of tests per Member State shall be one for every 40 000 new motor vehicles registered in that Member State in the preceding year, but shall not be less than five tests.

Each test shall verify compliance with the applicable regulatory acts listed in Annex II.

3. Market surveillance authorities carrying out more than five tests per year shall carry out at least 20 % of the minimum number of tests in the form of emission-related tests comparable to type-approval tests covering all applicable emissions-related requirements to the tested type laid down in the regulatory acts listed in Annex II.

4. The market surveillance authority of one Member State may agree with the market surveillance authority of another Member State that the market surveillance authority of that other Member State carries out the tests required under paragraphs 2 and 3.

5. The market surveillance authority of a Member State may agree with the Commission that the Commission carries out tests required under paragraph 3 at the expense of that Member State. Any tests carried out under this paragraph shall count towards the minimum number of tests required under paragraph 2.

6. Each Member State shall prepare annually a comprehensive overview of its planned market surveillance checks which it shall submit to the Forum no later than 1 March.

7. Every two years, each Member State shall draw up a report of its findings following any compliance verification checks it has carried out in the previous two years. That report shall be submitted to the Forum by 30 September of the year following the end of the two-year period concerned.

8. Market surveillance authorities shall require economic operators to make available to the authorities such documentation, information and other technical specifications, including access to software and algorithms, that the authorities consider necessary for the purpose of carrying out the market surveillance activities.

9. For type-approved vehicles, systems, components and separate technical units, market surveillance authorities shall take due account of certificates of conformity, type-approval marks or type-approval certificates presented by economic operators.

10. Market surveillance authorities shall take appropriate measures to alert users within the territories of their Member States within an adequate timeframe of hazards that they or the Commission have identified in relation to any vehicle, system, component or separate technical unit so as to prevent or reduce the risk of injury or other damage, including by making such information available on the website of the market surveillance authority.

Market surveillance authorities shall cooperate with economic operators regarding actions that could prevent or reduce the risks caused by vehicles, systems, components or separate technical units that those operators have made available on the market.

11. Where the market surveillance authorities of one Member State decide to withdraw a vehicle, system, component or separate technical unit from the market in accordance with Chapter XI, they shall inform the economic operator concerned and the relevant approval authority.

12. Market surveillance authorities shall carry out their duties independently and impartially. They shall observe confidentiality in order to protect commercial secrets, subject to the obligation laid down in Article 9(4) to make information available to the Commission and to other applicable disclosure requirements laid down in Union law in order to protect the interests of users in the Union.

13. The market surveillance authorities of the different Member States shall coordinate their market surveillance activities, cooperate with each other and shall share the results of those activities with each other and with the Forum. Where appropriate, the market surveillance authorities shall agree on work-sharing and specialisation.

14. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate efficiently and effectively, and shall share information relevant to their respective roles and functions.

15. The Commission may adopt implementing acts laying down common criteria for establishing the adequate scale of the compliance verification checks referred to in paragraph 1 of this Article and laying down common criteria for the format of the overview and the reporting referred to respectively in paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

Article 9

Compliance verification by the Commission

1. The Commission shall organise and carry out, at its own expense, tests and inspections to verify that vehicles, systems, components and separate technical units comply with the relevant requirements.

The tests and inspections shall be performed, inter alia, by means of laboratory tests and on-road tests, on the basis of statistically relevant samples, and shall be supplemented by documentary checks.

When carrying out those tests and inspections, the Commission shall take account of:

(a) established principles of risk assessment;

(b) substantiated complaints; and

(c) any other relevant information, including information exchanged in the Forum, testing results published by recognised third parties that meet the requirements laid down by the implementing acts referred to in Article 13(10), information concerning new technologies on the market and reports resulting from on-road remote sensing.

The Commission may entrust the performance of tests or inspections to technical services, in which case, the technical service shall be acting on behalf of the Commission. Where the Commission entrusts the performance of tests or inspections to technical services for the purposes of this Article, the Commission shall ensure that the technical service that is used is not the same as the technical service that performed the original type-approval test.

Those tests and inspections may take place:

(a) on new vehicles supplied by manufacturers or other economic operator, as provided for in paragraph 2;

(b) on registered vehicles with the agreement of the holder of the vehicle registration certificate.

2. Manufacturers holding type-approvals or other economic operators shall, upon request, supply to the Commission, in return for fair compensation, a statistically relevant number of production vehicles, systems, components and separate technical units selected by the Commission that are representative for the vehicles, systems, components and separate technical units available for placing on the market under that type-approval. Such vehicles, systems, components and separate technical units shall be supplied for testing at the time and place, and for such period, as required by the Commission.

3. Before the Commission carries out its tests and inspections, it shall notify the Member State that granted the type-approval and the Member State where the vehicle, system, component or separate technical unit was made available on the market.

The Member States shall cooperate with the Commission when the Commission carries out the tests and inspections.

4. For the purpose of enabling the Commission to carry out the tests and inspections under this Article, Member States shall without undue delay make available to the Commission the necessary information related to the type-approval of the vehicles, systems, components and separate technical units that are subject to compliance verification. That information shall include at least the information included in the EU type-approval certificate and its attachments referred to in Article 28(1).

5. Manufacturers shall make available to the Commission, free of charge and without undue delay, any data which are needed for the purpose of compliance verification and which are not available in the EU type-approval certificate and its attachments referred to in Article 28(1).

Such data shall include all parameters and settings that are necessary to accurately replicate the test conditions that applied at the time of the type-approval testing. The Commission shall adopt implementing acts specifying the data that are to be made available, subject to the protection of commercial secrets and the preservation of personal data pursuant to Union and national law. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

6. Where the Commission establishes that the vehicles, systems, components or separate technical units do not comply with the type-approval requirements laid down in this Regulation, that the vehicles, systems, components or separate technical unit do not comply with the type-approval or that the type-approval has been granted on the basis of incorrect data, it shall initiate the procedure provided for in Articles 53 or 54.

Where the tests and inspections call into question the correctness of the type-approval itself, the Commission shall immediately inform the approval authority or authorities concerned as well as the Forum.

The Commission shall inform the relevant approval authorities and market surveillance authorities in order for them to take appropriate measures to alert users within the Union, within an adequate timeframe, of any non-compliance that it has identified in relation to any vehicle, system, component or separate technical unit so as to prevent or reduce the risk of injury or other damage.

The Commission shall make publicly available a report of its findings following any compliance verification testing it has carried out and shall forward its findings to the Member States and to the Forum. That report shall contain details of the vehicles, systems, components and separate technical units that were assessed and the identity of the manufacturer concerned, as well as a short description of the findings, including the nature of the non-compliance, if any.

Article 10

Assessments by the Commission

1. The Commission shall organise and carry out assessments of the procedures put in place by approval authorities that have granted EU type-approvals within the five years preceding the assessment, in particular of the procedures for granting type-approvals, for carrying out conformity of production and for the designation and monitoring of technical services. Such assessments shall include an evaluation, using a random sample, of the compliance of granted type-approvals with applicable requirements referred to in point (c) of Article 26(2) within the five years preceding the assessment.

2. The assessments shall aim to assist the approval authorities that grant EU type-approvals to ensure the uniform application of this Regulation and to share best practices.

3. The assessments shall be carried out in compliance with the law of the Member State concerned, with due regard for the rights of the authorities concerned, and shall comply with the principle of proportionality. The Commission shall carry out its duties independently and impartially, and shall observe confidentiality in order to protect commercial secrets in accordance with the applicable law. The Commission shall bear the costs arising from such assessments.

4. The approval authorities concerned shall facilitate the assessment by cooperating with the Commission, giving it any necessary assistance and providing it with any necessary documentation.

5. The Commission shall ensure that the personnel participating in the assessment are sufficiently qualified and adequately instructed. The Commission shall, a sufficient time before the assessment, inform the Member States and the approval authorities concerned of the date on which the assessment is to begin and the identity of the personnel who are to carry out the assessment. The duration of the assessment at the premises of the approval authority concerned shall not normally exceed two days, and shall not in any case exceed three days.

6. Each approval authority that has granted at least one EU type-approval during a five year period shall be assessed by the Commission once during that period.

By way of derogation from the first subparagraph, the assessment of an approval authority may be less frequent if the Commission considers that the first assessment of that authority demonstrates that the procedures put in place ensure the effective application of this Regulation, taking into account the scope and range of EU type-approvals granted.

7. The Commission shall communicate the outcome of the assessment, including any recommendations, to the Forum and shall make a summary of the outcome publicly available. The Forum shall examine the outcome of the assessment.

8. The Member States shall report to the Commission and to the Forum on how they address any recommendations included in the outcome of the assessment.

9. Taking duly into account the considerations of the Forum, the Commission shall adopt implementing acts laying down common criteria for setting out the scope of, and the methodology used for, the assessment, the composition of the assessment team, the plan for the assessments covering a period of at least five years and the specific conditions under which the frequency of such assessments may be reduced. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

Article 11

Forum for Exchange of Information on Enforcement

1. The Commission shall establish, chair and manage a Forum for Exchange of Information on Enforcement (‘the Forum’).

The Forum shall be composed of representatives appointed by each Member State representing their approval authorities and market surveillance authorities.

Whenever appropriate, technical services, recognised third parties that meet the requirements laid down by the implementing acts referred to in Article 13(10), representatives of the European Parliament, of the industry and of the relevant economic operators, as well as of stakeholders involved in safety and environment matters, may be invited as observers to the Forum in accordance with the rules of procedures referred to in paragraph 7 of this Article.

The advisory tasks of the Forum shall have as their objective the promotion of best practices in order to facilitate the uniform interpretation and implementation of this Regulation, the exchange of information on enforcement problems, cooperation, in particular regarding the assessment, designation and monitoring of technical services, the development of working methods and tools, the development of an electronic information exchange procedure, and the evaluation of harmonised enforcement projects and penalties.

2. The Forum shall consider: (a) matters related to the uniform interpretation of the requirements laid down in this Regulation and in the regulatory acts listed in Annex II during implementation of those requirements; (b) the results of the activities relating to type-approval and market surveillance that were carried out by Member States in accordance with Article 6(8) and (9); (c) the results of tests and inspections carried out by the Commission in accordance with Article 9; (d) the assessments carried out by the Commission in accordance with Article 10; (e) test reports regarding possible non-compliance presented by recognised third parties that meet the requirements laid down by the implementing acts referred to in Article 13(10); (f) the results of the conformity of production activities carried out by approval authorities in accordance with Article 31; (g) the information submitted by Member States under Article 67(6) on their procedures for the assessment, designation and notification of technical services and for the monitoring of technical services; (h) matters of general relevance with regard to the implementation of the requirements laid down in this Regulation in relation to the assessment, designation and monitoring of technical services in accordance with Articles 67(10) and 78(4); (i) infringements by economic operators; (j) implementation of the corrective or restrictive measures laid down in Chapter XI; (k) the planning, coordination and results of market surveillance activities; (l) matters regarding access to vehicle OBD information and vehicle repair and maintenance information set out in Chapter XIV and, in particular, matters regarding the implementation of the procedures established under Article 65.

3. On the basis of the reports submitted by Member States in accordance with Article 8(7), the Commission shall make a summary report on market surveillance activities publicly available on a two-yearly basis.

4. Each year the Commission shall present a summary of the activities of the Forum to the European Parliament.

5. As part of its advisory task and taking into account the outcome of the considerations under paragraph 2, the Forum may express an opinion or issue a recommendation.

When expressing an opinion or issuing recommendations the Forum shall endeavour to reach a consensus. If no such consensus can be reached, the Forum shall express its opinion or issue its recommendations by a simple majority of the Member States. Each Member State shall have one vote. Member States with diverging positions may request that their positions and the grounds on which they are based be recorded in the Forum's opinion or recommendations.

6. When adopting implementing acts, the Commission shall duly take into account the opinions expressed by the Forum in accordance with paragraph 5.

7. The Forum shall establish its rules of procedure.

Article 12

Online data exchange

1. The Commission and the Member States shall use the common secure electronic exchange system referred to in Article 27 for EU type-approval certificates and their attachments referred to in Article 28(1), including for any test reports as well as amendments, refusals or withdrawals of any EU type-approval.

The Commission and Member States shall use the Rapid Information System (RAPEX), established under Directive 2001/95/EC of the European Parliament and of the Council ( 5 ) and the Information and Communication System on Market Surveillance (ICSMS), established under Regulation (EC) No 765/2008 for market surveillance, recalls and other relevant activities between market surveillance authorities, Member States and the Commission.

2. From 5 July 2026, Member States shall make accessible to the public, by vehicle identification number, the certificate of conformity of each vehicle as structured data in electronic format in the common secure electronic exchange system, in accordance with Article 37.

From 5 July 2026, Member States shall make accessible to the public the information contained in the certificate of conformity, excluding vehicle identification numbers, as structured data in electronic format in the common secure electronic exchange system, in accordance with Article 37.

The Commission shall adopt implementing acts establishing the format of, and the criteria for public access to, the information referred to in the first and second subparagraphs of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

3. The Commission shall take all necessary measures to establish an interface between the common secure electronic exchange system referred to in Article 27, RAPEX and ICSMS in order to facilitate market surveillance activities and ensure coordination, consistency and accuracy of the information provided to consumers and third parties.

4. Member States shall use the common secure electronic exchange system referred to in Article 27, in order to make a list of the EU type-approvals for vehicles, systems, components and separate technical units that they have granted, amended, refused or withdrawn, as well as a list of the technical services which have performed the tests for the respective EU type-approvals, accessible to the public as from 1 September 2022.

The Commission shall adopt implementing acts establishing the format of, and the criteria for public access to, the information referred to in the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

5. The Commission shall develop a tool to make publicly accessible test results and complaints about the performance of vehicles, systems, components and separate technical units from recognised third parties that meet the requirements laid down by the implementing acts referred to in Article 13(10).

Article 13

General obligations of manufacturers

1. Manufacturers shall ensure that the vehicles, systems, components and separate technical units that they have manufactured and that are placed on the market have been manufactured and approved in accordance with the requirements laid down in this Regulation, and in particular, those in Article 5.

2. Manufacturers shall be responsible to the approval authority for all aspects of the approval procedure and for ensuring conformity of production.

In the case of multi-stage type-approval, manufacturers shall also be responsible for the approval and conformity of production of the systems, components or separate technical units that they have added at the stage of vehicle completion. Manufacturers who modify components, systems or separate technical units already approved at earlier stages shall be responsible for the type-approval and conformity of production of the modified components, systems or separate technical units. Manufacturers of the previous stage shall provide information to manufacturers of the subsequent stage regarding any change that may affect component type-approval, system type-approval or separate technical unit type-approval or the whole-vehicle type-approval. Such information shall be provided as soon as the new extension to the whole-vehicle type-approval has been granted and at the latest on the starting date of manufacture of the incomplete vehicle.

3. Manufacturers who modify an incomplete vehicle in such a manner that it qualifies as a different category of vehicle, with the consequence that the requirements already assessed in a previous stage of type-approval have changed, shall also be responsible for compliance with the requirements applicable to the category of vehicles for which the modified vehicle qualifies.

4. For the purposes of EU type-approval of vehicles, systems, components and separate technical units, a manufacturer established outside the Union shall appoint a single representative established within the Union to represent the manufacturer before the approval authority. That manufacturer shall also appoint a single representative established within the Union for the purposes of market surveillance, who may be the same as the representative appointed for the purposes of EU type-approval.

5. Manufacturers shall ensure that their vehicles, systems, components and separate technical units are not designed to incorporate strategies or other means that alter the performance exhibited during test procedures in such a way that they do not comply with this Regulation when operating under conditions that can reasonably be expected in normal operation.

6. Manufacturers shall establish procedures to ensure that series production of vehicles, systems, components and separate technical units remains in conformity with the approved type.

7. Manufacturers shall examine any complaints they receive relating to risks, suspected incidents or non-compliance issues with the vehicles, systems, components, separate technical units, parts and equipment that they have placed on the market.

Manufacturers shall keep a record of such complaints, including for each complaint a description of the issue and the details needed to precisely identify the affected type of vehicle, system, component, separate technical unit, part or equipment, and, in the case of substantiated complaints, manufacturers shall keep their distributors and importers informed thereof.

8. In addition to the statutory plate fixed to their vehicles and type-approval marks fixed to their components or separate technical units in accordance with Article 38, manufacturers shall indicate their name, registered trade name or registered trade mark and their contact address in the Union on their vehicles, components or separate technical units made available on the market or, where that is not possible, on the packaging or in a document accompanying the component or separate technical unit.

9. Manufacturers shall ensure that, while a vehicle, system, component or separate technical unit is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements laid down in this Regulation.

10. Without prejudice to Article 9(5) and subject to the protection of commercial secrets and the preservation of personal data pursuant to Union and national law, manufacturers of vehicles shall make available data which is needed for testing by third parties for possible non-compliance, including all parameters and settings that are necessary to accurately replicate the test conditions that were applied at the time of the type-approval testing.

For the purposes of the first subparagraph of this paragraph, the Commission shall adopt implementing acts specifying the data to be made available free of charge, as well as the requirements to be met by third parties to demonstrate their legitimate interest in the fields of public safety or environmental protection and their recourse to adequate testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

Article 14

Obligations of manufacturers concerning their vehicles, systems, components, separate technical units, parts and equipment that are not in conformity or that present a serious risk

1. Where a vehicle, system, component, separate technical unit, part or equipment that has been placed on the market or that has entered into service is not in conformity with this Regulation or where the type-approval has been granted on the basis of incorrect data, the manufacturer shall immediately take the corrective measures necessary to bring that vehicle, system, component, separate technical unit, part or equipment into conformity, to withdraw it from the market or to recall it, as appropriate.

The manufacturer shall immediately inform the approval authority that granted the type-approval in detail of the non-conformity and of any measures taken.

2. Where the vehicle, system, component, separate technical unit, part or equipment presents a serious risk, the manufacturer shall immediately provide to the approval authorities and market surveillance authorities detailed information on the risk and on any measures taken in relation thereto.

3. Manufacturers shall keep the EU type-approval certificates and their attachments referred to in Article 28(1) for a period of 10 years after the end of validity of the EU type-approval of a vehicle and for a period of five years after the end of validity of the EU type-approval of a system, component or separate technical unit.

Manufacturers of a vehicle shall keep at the disposal of the approval authorities for a period of 10 years from the date of manufacture of the vehicle a copy of the certificates of conformity referred to in Article 36.

4. Manufacturers shall, following a reasoned request from a national authority or the Commission, provide that authority or the Commission, with a copy of the EU type-approval certificate, or the authorisation referred to in Article 55(1) demonstrating conformity of the vehicle, system, component, separate technical unit, part or equipment, in a language that can be easily understood by the national authority or the Commission.

Manufacturers shall, following a reasoned request from a national authority, cooperate with that authority on any action taken in accordance with Article 20 of Regulation (EC) No 765/2008 to eliminate the risks posed by the vehicle, system, component, separate technical unit, part or equipment that they have made available on the market.

Article 15

Obligations of manufacturer's representatives

1. The manufacturer's representative shall perform the tasks specified in the mandate received from the manufacturer. That mandate shall at least, provide for the representative to: (a) have access to the EU type-approval certificate and its attachments referred to in Article 28(1), and to the certificate of conformity in one of the official Union languages; such documentation shall be made available to the approval authorities and to the market surveillance authorities for a period of 10 years after the end of the validity of the EU type-approval of a vehicle and for a period of five years after the end of validity of the EU type-approval of a system, component or separate technical unit; (b) provide an approval authority, following a reasoned request from that authority, with all information, documentation and any other technical specifications, including access to software and algorithms, that are necessary to demonstrate the conformity of production of a vehicle, system, component or separate technical unit; (c) cooperate with the approval authorities or the market surveillance authorities, at their request, on any action taken to eliminate the serious risk posed by vehicles, systems, components, separate technical units, parts or equipment covered by that mandate; (d) immediately inform the manufacturer about complaints and reports relating to risks, suspected incidents or non-compliance issues that relate to vehicles, systems, components, separate technical units, parts or equipment covered by that mandate; (e) have the right to terminate the mandate without penalty if the manufacturer acts contrary to its obligations under this Regulation.

2. A manufacturer's representative who terminates the mandate on the grounds referred to in point (e) of paragraph 1 shall immediately inform both the approval authority that granted the type-approval and the Commission.

The information to be provided shall specify at least:

(a) the date of termination of the mandate;

(b) the date until which the outgoing manufacturer's representative may be indicated in the information supplied by the manufacturer, including any promotional material;

(c) the transfer of documents, including confidentiality aspects and property rights;

(d) the obligation of the outgoing manufacturer's representative after the end of the mandate to forward to the manufacturer or incoming manufacturer's representative any complaints or reports about risks and suspected incidents relating to a vehicle, system, component, separate technical unit, part or equipment for which the outgoing manufacturer's representative had been designated as manufacturer's representative.

Article 16

Obligations of importers

1. Importers shall only place on the market vehicles, systems, components or separate technical units that comply with this Regulation.

2. Before placing on the market a type-approved vehicle, system, component or separate technical unit, importers shall verify that it is covered by a valid EU type-approval certificate and that the system, component or separate technical unit bears the required type-approval mark and complies with Article 13(8).

In the case of a vehicle, the importer shall ensure that the vehicle is accompanied by the required certificate of conformity.

3. Where a vehicle, system, component or separate technical unit is not in conformity with the requirements of this Regulation, and in particular where it does not correspond to its type-approval, importers shall not place on the market, allow to enter into service or register the vehicle, system, component or separate technical unit, until it has been brought into conformity.

4. Where a vehicle, system, component, separate technical unit, part or equipment presents a serious risk, importers shall inform the manufacturer and the market surveillance authorities thereof. For type-approved vehicles, systems, components and separate technical units, importers shall also inform the approval authority that granted the type-approval.

5. Importers shall indicate their name, registered trade name or registered trade mark, and their contact address on the vehicle, component, separate technical unit, part or equipment, or, where this is not possible, on its packaging or in a document accompanying the component, separate technical unit, part or equipment.

6. Importers shall ensure that the vehicle, system, component or separate technical unit is accompanied by instructions and information, as required by Article 59, in the official language or languages of the Member States concerned.

7. To protect the health and safety of consumers, importers shall keep a record of complaints and recalls relating to vehicles, systems, components, separate technical units, parts or equipment that they have placed on the market, and shall keep their distributors informed of such complaints and recalls.

8. Importers shall immediately inform the relevant manufacturer of any complaints they received regarding risks, suspected incidents or non-compliance issues relating to vehicles, systems, components, separate technical units, parts or equipment that they have placed on the market.

9. Importers shall ensure that, while a vehicle, system, component or separate technical unit is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements laid down in this Regulation.

Article 17

Obligations of importers concerning their vehicles, systems, components, separate technical units, parts and equipment that are not in conformity or that present a serious risk

1. Where a vehicle, system, component, separate technical unit, part or equipment that has been placed on the market by importers is not in conformity with this Regulation, importers shall immediately take the corrective measures necessary to bring that vehicle, system, component, separate technical unit, part or equipment into conformity under the manufacturer's supervision, to withdraw it from the market or to recall it, as appropriate. Importers shall also inform the manufacturer and the approval authority that granted the EU type-approval.

2. Where a vehicle, system, component, separate technical unit, part or equipment that has been placed on the market presents a serious risk, importers shall immediately provide detailed information on the serious risk to the manufacturers and the approval authorities and market surveillance authorities.

Importers shall also inform the approval authorities and market surveillance authorities of any action taken and give details, in particular of the serious risk and of any measure taken by the manufacturer.

3. Importers shall, for a period of 10 years after the end of the validity of EU type-approval of a vehicle and for a period of five years after the end of the validity of the EU type-approval of a system, component or separate technical unit, keep a copy of the EU type-approval certificate and its attachments referred to in Article 28(1), and shall ensure that they can be made available to the approval authorities and market surveillance authorities upon request.

4. Importers shall, following a reasoned request from a national authority, provide that authority with all information and documentation necessary to demonstrate the conformity of a vehicle, system, component or separate technical unit, in a language that can be easily understood by that authority.

Importers shall, following a reasoned request from a national authority, cooperate with that authority on any action taken in accordance with Article 20 of Regulation (EC) No 765/2008 to eliminate the risks posed by the vehicle, system, component, separate technical unit, part or equipment that they have made available on the market.

Article 18

Obligations of distributors

1. Distributors shall verify, before making available on the market a vehicle, system, component or separate technical unit, that the vehicle, system, component or separate technical unit bears the required statutory plate or type-approval mark, that it is accompanied by the required documents and by instructions and safety information, as required by Article 59, in the official language or languages of the relevant Member State, and that the manufacturer and the importer have complied with the requirements set out in Article 13(8) and Article 16(5) respectively.

2. Distributors shall immediately inform the relevant manufacturer of any complaints they received relating to risks, suspected incidents or non-compliance issues with vehicles, systems, components, separate technical units, parts or equipment that they have made available on the market.

3. Distributors shall ensure that, while a vehicle, system, component or separate technical unit is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements laid down in this Regulation.

Article 19

Obligations of distributors concerning their vehicles, systems, components, separate technical units, parts and equipment that are not in conformity or that present a serious risk

1. Where a vehicle, system, component, separate technical unit, part or equipment is not in conformity with the requirements of this Regulation, distributors shall inform the manufacturer, the importer and the approval authority that granted the EU type-approval in respect thereof, and shall not make available on the market the vehicle, system, component, separate technical unit, part or equipment until it has been brought into conformity.

2. Where a vehicle, system, component, separate technical unit, part or equipment that distributors have made available on the market is not in conformity with this Regulation, they shall inform the manufacturer, the importer and the approval authority that granted the EU type-approval.

3. Where a vehicle, system, component, separate technical unit, part or equipment presents a serious risk, distributors shall immediately provide detailed information on that serious risk to the manufacturer, the importer and the approval authorities and the market surveillance authorities of the Member States in which that vehicle, system, component, separate technical unit, part or equipment has been made available on the market.

Distributors shall also inform them of any action taken and give details of any measure taken by the manufacturer.

4. Distributors shall, following a reasoned request from a national authority, cooperate with that authority on any action taken in accordance with Article 20 of Regulation (EC) No 765/2008 to eliminate the risks posed by the vehicle, system, component, separate technical unit, part or equipment that they have made available on the market.

Article 20

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Articles 8, 13 and 14, in the following cases:

(a) where the importer or distributor makes available on the market, or is responsible for the entry into service of a vehicle, system, component or separate technical unit under its name or trademark, or modifies a vehicle, system, component or separate technical unit in such a way that the vehicle, system, component or separate technical unit may no longer comply with the applicable requirements; or

(b) where the importer or distributor makes available on the market or is responsible for the entry into service of a system, component or separate technical unit on the basis of a UN type-approval that was granted to a manufacturer outside the Union, and it is not possible to identify a manufacturer's representative in the territory of the Union.

Article 21

Identification of economic operators

Upon a request of an approval authority or a market surveillance authority, for a period of 10 years after the placing on the market of a vehicle and for a period of five years after the placing on the market of a system, component, separate technical unit, part or equipment, economic operators shall provide information on the following:

(a) the identity of any economic operator that has supplied them with a vehicle, system, component, separate technical unit, part or equipment;

(b) the identity of any economic operator to which they have supplied a vehicle, system, component, separate technical unit, part or equipment.







CHAPTER III

PROCEDURES FOR EU TYPE-APPROVAL

Article 22

Procedures for EU type-approval

1. Where applying for a whole-vehicle type-approval, the manufacturer may choose one of the following procedures: (a) step-by-step type-approval; (b) single-step type-approval; (c) mixed type-approval.

In addition, the manufacturer may choose a multi-stage type-approval for an incomplete or completed vehicle.

2. Without prejudice to the requirements of the regulatory acts listed in Annex II, for system type-approval, component type-approval and separate technical unit type-approval only the single-step type-approval is applicable.

3. Multi-stage type-approval shall be granted in respect of an incomplete or completed type of vehicle that, having regard to the state of completion of the vehicle, conforms to the particulars in the information folder referred to in Article 24 and that meets the technical requirements laid down in the relevant regulatory acts listed in Annex II.

Multi-stage type-approval shall also apply to complete vehicles that have been converted or modified by another manufacturer after their completion.

4. The EU type-approval for the final stage of completion shall only be granted after the approval authority has verified, in accordance with the procedures laid down in Annex IX, that the type of vehicle approved at the final stage meets all applicable technical requirements at the time of the approval. Verification shall include a documentary check of all requirements covered by an EU type-approval for an incomplete type of vehicle granted in the course of a multi-stage procedure, including where the EU type-approval was granted for a different category of vehicle.

5. The choice of the procedure for EU type-approval referred to in paragraph 1 shall not affect the applicable requirements with which the approved type of vehicle has to comply at the time of granting of the whole-vehicle type-approval.

6. Multi-stage type-approval may also be used by a single manufacturer, provided it is not used to circumvent the requirements applicable to vehicles built in a single stage. Vehicles built by a single manufacturer are not considered to have been built in multiple stages for the purposes of Articles 41, 42 and 49.

Article 23

Application for EU type-approval

1. The manufacturer shall submit to the approval authority an application for EU type-approval and the information folder referred to in Article 24.

2. Only one application shall be submitted in respect of a particular type of vehicle, system, component or separate technical unit. That single application shall be submitted in only one Member State and to only one approval authority therein.

A new application may not be submitted in another Member State in respect of the same type of vehicle, system, component or separate technical unit where:

(a) an approval authority has refused to grant a type-approval of that type;

(b) an approval authority has withdrawn type-approval of that type; or

(c) the manufacturer has revoked an application for a type-approval of that type.

The approval authority shall reject an application for a type-approval of a different type designation or of a modification with respect to a previous application where the changes are not sufficient to constitute a new type of vehicle, system, component or separate technical unit.

3. An application for an EU type-approval of a particular type of vehicle, system, component or separate technical unit shall include a declaration by the manufacturer certifying, in accordance with the second subparagraph of paragraph 2 that: (a) the manufacturer has not applied for an EU type-approval for the same type to any other approval authority, and no other approval authority granted the manufacturer such an approval; (b) no approval authority has refused to grant type-approval of that type; (c) no approval authority has withdrawn type-approval of that type; and (d) the manufacturer has not revoked an application for a type-approval of that type.

4. A separate application shall be submitted for each type of vehicle, system, component or separate technical unit to be approved.

Article 24

Information folder

1. The information folder shall include the following: (a) an information document, in accordance with the template laid down in the implementing acts referred to in paragraph 4, for single-step type-approval or mixed whole-vehicle type-approval or for step-by-step whole-vehicle type-approval or, in the case of the type-approval of a system, component or separate technical unit, in accordance with the relevant regulatory act listed in Annex II; (b) all data, drawings, photographs and other relevant information; (c) for vehicles, an indication of the procedure or procedures chosen in accordance with Article 22(1); (d) any additional information requested by the approval authority in the context of the EU type-approval procedure.

2. The information document referred to in point (a) of paragraph 1 for whole-vehicle type-approval shall contain a complete set of information on the characteristics of the type of vehicle that is necessary for the approval authority to identify the type of vehicle and to properly conduct the type-approval procedure.

3. The manufacturer shall submit the information folder to the approval authority in an electronic format that is acceptable to that authority. The approval authority may also accept the information folders that are submitted in paper format.

4. The Commission shall adopt implementing acts laying down the template for the information document and any other part of the information folder, and a harmonised electronic format for the purposes of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.

Article 25

Additional information to be provided with an application for EU type-approval

1. An application for a step-by-step type-approval shall be accompanied, in addition to the information folder referred to in Article 24, by the complete set of EU type-approval certificates or UN type-approval certificates, and their attachments, that are required pursuant to the regulatory acts listed in Annex II.

In the case of a system type-approval, a component type-approval or a separate technical unit type-approval, pursuant to the regulatory acts listed in Annex II, the approval authority shall have access to the information folder and, if applicable, the EU type-approval certificates and their attachments until the whole-vehicle type-approval is either granted or refused.

2. An application for a mixed type-approval shall be accompanied, in addition to the information folder referred to in Article 24, by the EU type-approval certificates or UN type-approval certificates, and their attachments, that are required pursuant to the regulatory acts listed in Annex II.

For systems for which no EU type-approval certificate or UN type-approval certificate has been presented, the application shall be accompanied, in addition to the information folder referred to in Article 24, by the information required for the approval of those systems during the vehicle approval phase, and by a test report instead of the EU type-approval certificate or UN type-approval certificate.

3. An application for a multi-stage type-approval shall be accompanied by the following information: (a) in the first stage, by those parts of the information folder and the EU type-approval certificates, UN type-approval certificates or, if applicable, the test reports, that are relevant to the state of completion of the base vehicle; (b) in the second and subsequent stages, by those parts of the information folder and the EU type-approval certificates or UN type-approval certificates that are relevant to the current stage of completion, together with a copy of the EU whole-vehicle type-approval certificate that was issued at the preceding stage of construction, as well as full details of any changes or additions that the manufacturer has made to the vehicle.

The information specified in this paragraph shall be supplied in accordance with Article 24(3).

4. The approval authority and technical services shall have the access to the software and algorithms of the vehicle that they consider to be necessary for the purpose of carrying out their activities.

The approval authority and technical services may also require the manufacturer to supply documentation or any additional information needed to allow the approval authority or technical services to develop an appropriate level of understanding of the systems, including the system development process and the system concept, as well as the functions of software and algorithms that are necessary to verify compliance with the requirements of this Regulation, to take a decision on which tests are required or to facilitate the execution of those tests.







CHAPTER IV

CONDUCT OF PROCEDURES FOR EU TYPE-APPROVAL

Article 26

General provisions on conduct of procedures for EU type-approval

1. For each type of vehicle, system, component or separate technical unit, only one EU type-approval may be granted.

2. An approval authority, having received an application in accordance with Article 23, shall only grant an EU type-approval after having verified all of the following: (a) the conformity of production arrangements referred to in Article 31; (b) that the declaration referred to in Article 23(3) has been submitted; (c) the compliance of the type of vehicle, system, component or separate technical unit with the applicable requirements; (d) in the case of whole-vehicle type-approvals in accordance with the step-by-step, mixed or multi-stage type-approval procedures, the approval authority shall verify, in accordance with Article 22(4), that the systems, components and separate technical units are covered by separate and valid type-approvals that have been granted pursuant to the requirements applicable at the time of the granting of the whole-vehicle type-approval.

3. The procedures with respect to EU type-approval, that are set out in Annex III, and the procedures with respect to multi-stage type-approval, set out in Annex IX, shall apply.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annexes III and IX to take into account regulatory and technological developments by updating the procedures therein with respect to EU type-approval and multi-stage type-approval.

4. The approval authority shall put together an information package consisting of the information folder referred to in Article 24, accompanied by the test reports and all other documents that were added to the information folder by the technical service or by the approval authority while carrying out their tasks.

The information package may be kept electronically. It shall contain an index that clearly indicates all of the pages and the format of each document, and that chronologically records any changes to the EU type-approval.

The approval authority shall keep the information package available for a period of 10 years after the end of the validity of the EU type-approval concerned.

5. The approval authority shall refuse to grant an EU type-approval where it finds that a type of vehicle, system, component or separate technical unit that complies with the applicable requirements nonetheless presents a serious risk to safety or may seriously harm the environment or public health. In such case, it shall immediately send to the approval authorities of the other Member States and to the Commission a detailed file explaining the reasons for its decision and setting out the evidence for its findings.

6. In accordance with Article 22(4), in the case of step-by-step, mixed and multi-stage type-approval procedures, the approval authority shall refuse to grant an EU type-approval where it finds that systems, components or separate technical units do not comply with the requirements set out in this Regulation.

The approval authority shall ask the approval authorities that granted type-approvals for the systems, components, or separate technical units, to act in accordance with Article 54(2).

Article 27

Notification of EU type-approval granted, amended, refused and withdrawn

1. The approval authority shall, when issuing or amending the EU type-approval certificate, make available to the approval authorities of the other Member States, to the market surveillance authorities, and to the Commission, a copy of the EU type-approval certificate for each type of vehicle, system, component and separate technical unit for which it has granted a type-approval and its attachments, including the test reports referred to in Article 30. That copy shall be made available by means of the common secure electronic exchange system in accordance with the implementing acts referred to in paragraph 3 of this Article.

2. The approval authority shall without delay inform the approval authorities of the other Member States and the Commission of its refusal or withdrawal of any EU type-approval, stating the reasons for its decision, by means of the common secure electronic exchange system in accordance with the implementing acts referred to in paragraph 3.

3. As regards the common secure electronic exchange system, the Commission shall adopt implementing acts laying down the format of the electronic documents that are to be made available, the exchange mechanism, the procedures to inform authorities on the granting of EU type-approvals, on amendments, refusals and withdrawals thereof and on the relevant security measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.

Article 28

EU type-approval certificate

1. The EU type-approval certificate shall contain the following attachments: (a) the information package referred to in Article 26(4); (b) the test reports referred to in Article 30 in the case of a system, component or separate technical unit type-approval, or the test results sheet in the case of whole-vehicle type-approval; (c) in the case of the whole-vehicle type-approval, the name and the specimen of the signature of the person or persons authorised to sign the certificates of conformity and a statement of their position in the company; (d) in the case of the whole-vehicle type-approval, a filled-out specimen of the certificate of conformity of the vehicle type.

2. The EU type-approval certificate shall be given a unique number in accordance with a harmonised numbering system, which shall at least allow for the identification of the Member State which granted the EU type-approval and for the identification of the requirements to which the type of vehicle, system, component or separate technical unit conforms.

3. The Commission shall adopt implementing acts laying down the templates for the EU type-approval certificate, the harmonised numbering system, and the test result sheet, respectively, including providing the relevant electronic formats. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.

4. In respect of each type of vehicle, system, component and separate technical unit, the approval authority shall: (a) complete all the relevant sections of the EU type-approval certificate, including its attachments; (b) compile the index to the information package as referred to in Article 26(4); (c) issue the completed EU type-approval certificate and its attachments to the manufacturer without delay.

5. In the case of an EU type-approval, the validity of which has been restricted in accordance with Article 39, Article 43 or Part III of Annex II, or in relation to which certain provisions of this Regulation or of the regulatory acts listed in Annex II do not apply, the EU type-approval certificate shall specify those restrictions or the relevant provisions that do not apply.

6. Where a manufacturer of a vehicle chooses the mixed type-approval procedure, the approval authority shall complete the information package as referred to in Article 26(4) with the references to the test reports referred to in Article 30 for the systems, components or separate technical units for which no EU type-approval certificate has been issued. The approval authority shall also clearly identify in the information package the technical requirements of the regulatory acts listed in Annex II against which the vehicle was tested.

7. Where a manufacturer of a vehicle chooses the single-step type-approval procedure, the approval authority shall attach to the EU type-approval certificate a list of relevant regulatory acts in accordance with the template provided in the implementing acts referred to in paragraph 3.

Article 29

Specific provisions concerning EU type-approvals for systems, components and separate technical units

1. An EU type-approval shall be granted in respect of a system, component or separate technical unit that conforms to the particulars in the information folder referred to in Article 24 and that meets the technical requirements laid down in the relevant regulatory acts listed in Annex II.

2. Where components or separate technical units, whether or not intended for repair, servicing or maintenance, are also covered by a system type-approval with respect to a vehicle, no additional component or separate technical unit type-approval shall be required unless such type-approval is provided for under the relevant regulatory acts listed in Annex II.

3. Where a component or separate technical unit fulfils its function or offers a specific feature only in conjunction with other parts of the vehicle, thereby making it possible to verify compliance only where the component or separate technical unit operates in conjunction with those other vehicle parts, the scope of the EU type-approval of the component or the separate technical unit shall be restricted accordingly.

In such cases, the EU type-approval certificate shall specify any restrictions on the use of the component or the separate technical unit, and shall indicate the special conditions for fitting that component or separate technical unit in a vehicle.

Where that component or separate technical unit is fitted in a vehicle, the approval authority shall verify, at the time of the approval of the vehicle, that the component or separate technical unit complies with all applicable restrictions on the use or conditions for fitting.

Article 30

Tests required for EU type-approval

1. For the purpose of granting EU type-approvals, the approval authority shall verify compliance with the technical requirements of this Regulation by means of appropriate tests that are performed by its technical services.

2. The fundamental elements of the tests, including the technical requirements for which compliance was verified by the tests, shall be recorded in a test report.

3. The Commission shall adopt implementing acts laying down the format of the test reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.

4. The manufacturer shall make available to the approval authorities and provide to the technical services concerned the vehicles, systems, components or separate technical units that are required under the relevant regulatory acts listed in Annex II for the performance of the required tests.

5. The required tests shall be performed on vehicles, systems, components and separate technical units that are representative of the type to be approved.

6. Where a range of values is provided for the parameters and for the conditions used for the performance of the appropriate tests referred to in paragraph 1, the technical services may choose any value within that range.

7. At the request of the manufacturer, and subject to the agreement of the approval authority, virtual testing methods may be used in accordance with Annex VIII as alternatives to the tests referred to in paragraph 1.

8. The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex VIII to take into account technical and regulatory developments by updating the list of regulatory acts in respect of which virtual testing methods may be used by a manufacturer or a technical service and the specific conditions under which those virtual testing methods are to be used.

Article 31

Conformity of production arrangements

1. An approval authority that has granted an EU type-approval shall take the necessary measures in accordance with Annex IV to verify, if necessary in cooperation with the approval authorities of the other Member States, that the manufacturer produces the vehicles, systems, components or separate technical units in conformity with the approved type.

2. An approval authority that has granted a whole-vehicle type-approval shall verify a statistically relevant number of samples of vehicles and certificates of conformity on their compliance with Articles 36 and 37 and shall verify that the data in those certificates of conformity are correct.

3. An approval authority that has granted an EU type-approval shall take the necessary measures to verify, if necessary in cooperation with the approval authorities of the other Member States, that the arrangements referred to in paragraphs 1 and 2 of this Article continue to be adequate so that vehicles, systems, components or separate technical units in production continue to conform to the approved type and that certificates of conformity continue to comply with Articles 36 and 37.

4. In order to verify that a vehicle, system, component or separate technical unit conforms to the approved type, the approval authority that granted the EU type-approval shall take the necessary measures to carry out the checks or tests on samples taken at the manufacturer's premises, including production facilities that are required for EU type-approval.

In accordance with Annex IV, the approval authority shall take the necessary measures to carry out such checks or tests with the frequency set out in the regulatory acts listed in Annex II, or, if no frequency is specified in those acts, at least once every three years.

5. In order to verify that a vehicle, system, component or separate technical unit conforms to the approved type, the approval authority or the technical services shall: (a) if a range of values is provided for in the test procedures laid down in the relevant regulatory acts listed in Annex II, set the values in a random manner within the provided range when carrying out checks or tests; and (b) have access to the software, algorithms, documentation and any additional information in accordance with Article 25(4).

6. An approval authority that has granted an EU type-approval shall take the necessary measures to verify that the manufacturer complies with the obligations set out in Chapter XIV. It shall verify in particular whether, in order to comply with those obligations, the manufacturer has amended or supplemented the vehicle OBD information and vehicle repair and maintenance information.

7. Where an approval authority that has granted an EU type-approval establishes that the manufacturer no longer produces the vehicles, systems, components or separate technical units in conformity with the approved type or with the requirements of this Regulation, or establishes that the certificates of conformity no longer comply with Articles 36 and 37, even though production is continued, it shall take the necessary measures to ensure that the arrangements for conformity of production are followed correctly or withdraw the type-approval. The approval authority may decide to take all necessary restrictive measures in accordance with Chapter XI.

8. The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex IV to take account of technological and regulatory developments by updating the conformity of production procedures.

Article 32

Fees

1. The fees for EU type-approval activities shall be levied on the manufacturers who have applied for EU type-approval in the Member State concerned.

The Member State shall ensure that sufficient resources are available to cover the costs for market surveillance activities. Without prejudice to national law, those costs may be recovered by fees that can be levied by the Member State in which the vehicles are placed on the market.

2. The Member States may levy administrative fees on technical services applying to be designated to cover wholly or partly the costs relating to the activities exercised by the national authorities responsible for technical services in accordance with this Regulation.







CHAPTER V

AMENDMENTS TO AND VALIDITY OF EU TYPE-APPROVALS

Article 33

General provisions on amendments of EU type-approvals

1. The manufacturer shall inform the approval authority that granted the EU type-approval without delay of any change in the particulars recorded in the information package referred to in Article 26(4), including any change in the extended documentation package under the regulatory acts listed in Annex II.

The approval authority shall decide whether that change requires an amendment, in the form of either a revision or an extension of the EU type-approval in accordance with Article 34, or whether that change requires a new EU type-approval.

2. An application for an amendment shall only be submitted to the approval authority that granted the existing EU type-approval.

3. Where an approval authority finds that an amendment requires the repetition of inspections or tests, it shall inform the manufacturer accordingly.

4. Where an approval authority finds on the basis of the inspections or tests referred to in paragraph 3 of this Article that the requirements for the EU type-approval continue to be fulfilled, the procedures referred to in Article 34 shall apply.

5. Where the approval authority finds that the changes in the particulars recorded in the information package cannot be covered by an extension of the existing type-approval, it shall refuse to amend the EU type-approval and shall request the manufacturer to apply for a new EU type-approval.

Article 34

Revisions and extensions of EU type-approvals

1. An amendment shall be designated a ‘revision’ where an approval authority finds that, despite the change in the particulars recorded in the information package referred to in Article 26(4), the concerned type of vehicle, system, component or separate technical unit continues to comply with the applicable requirements for that type and that, therefore, no inspections or tests need to be repeated.

In such case, the approval authority shall issue the revised pages of the information package as necessary and without delay, marking each revised page to show clearly the nature of the change and the date of reissue, or it shall issue a consolidated, updated version of the information package, accompanied by a detailed description of the changes.

2. The amendment shall be designated an ‘extension’ where the approval authority finds that the particulars recorded in the information package have changed, and where any of the following apply: (a) further inspections or tests are required to verify continued compliance with the requirements upon which the existing EU type-approval has been based; (b) any information on the EU type-approval certificate, except for its attachments, has changed; or (c) new requirements under any regulatory act listed in Annex II become applicable to the approved type of vehicle, system,