EN Official Journal of the European Union L 151/1

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) In accordance with Article 26(2) of the Treaty on the Functioning of the European Union (TFEU), the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is to be ensured. Internal market rules should be transparent, simple, consistent and effective, thereby providing legal certainty and clarity for the benefit of businesses and consumers.

(2) To that end, a comprehensive EU framework for the approval of motor vehicles and their trailers, and of the systems, components and separate technical units intended for such vehicles, was established by Directive 2007/46/EC of the European Parliament and of the Council (3).

(3) In 2013, the Commission carried out an assessment of the Union legal framework for the type-approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles which showed that the framework established by Directive 2007/46/EC is appropriate for achieving the main goals of harmonisation, effective functioning of the internal market and fair competition, and concluded that it should therefore continue to apply.

(4) That assessment also concluded, however, that there is a need to introduce market surveillance provisions to complement the type-approval requirements; a need to clarify the recall and safeguard procedures, as well as the conditions for granting extensions to approvals for existing types of vehicle; a need to improve the enforcement of the framework for type-approval by harmonising and enhancing the type-approval procedures and conformity of production procedures applied by Member States' authorities and technical services; a need to clearly delineate the roles and responsibilities of economic operators in the supply chain, and of the authorities and parties involved in the enforcement of the framework, guaranteeing the independence of those authorities and parties, and preventing conflicts of interest; and a need to improve the suitability of alternative approval schemes (national small series and individual vehicle approvals) and the suitability of the multi-stage type-approval process to provide appropriate flexibility for niche markets and small and medium-sized enterprises without, however, distorting the level playing field.

(5) In addition, recent problems with the implementation of the framework for EU type-approval have revealed particular weaknesses and have demonstrated the need for its fundamental revision in order to ensure that it is robust, transparent, predictable and sustainable and that it provides a high level of safety and of health and environmental protection.

(6) This Regulation introduces a number of safeguards to prevent requirements imposed in the process of granting approval to vehicles, systems, components or separate technical units from being misapplied. In order to prevent abuse of the approval process in the future, it is important that those safeguards are effective.

(7) This Regulation lays down harmonised rules and principles for the type-approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, and for individual vehicle approval, with a view to ensuring the proper functioning of the internal market for the benefit of businesses and consumers and in order to offer a high level of safety and of health and environmental protection.

(8) This Regulation lays down the technical and administrative type-approval requirements for motor vehicles for the carriage of passengers (category M), and motor vehicles for the carriage of goods (category N) and their trailers (category O), and for the systems, components and separate technical units intended for such vehicles with a view to ensuring a high level of safety and of environmental performance.

(9) National authorities should apply and enforce the requirements of this Regulation in a uniform manner across the Union to ensure a level playing field and to avoid divergent standards being applied across the Union. They should fully cooperate with the Forum for Exchange of Information on Enforcement (‘the Forum’) and with the Commission in its audit and oversight activities.

(10) This Regulation should strengthen the current framework for EU type-approval, in particular through the introduction of provisions on market surveillance. Market surveillance in the automotive sector should be introduced by specifying the obligations of the economic operators in the supply chain, the responsibilities of the enforcement authorities in the Member States, and the measures to be taken when automotive products are encountered on the market that represent serious safety or environmental risks, that undermine the protection of consumers, or that do not comply with the type-approval requirements.

(11) In order to ensure an effective implementation of the type-approval requirements, the current provisions on conformity of production should be enhanced by, inter alia, providing for mandatory periodic audits of the conformity control methods and of the continued conformity of the automotive products concerned and, by reinforcing the requirements relating to the competence, obligations and performance of the technical services that carry out tests for whole-vehicle type-approval under the responsibility of approval authorities. The proper functioning of technical services is crucial for ensuring a high level of safety and of environmental protection and citizens' confidence in the system. The criteria for designation of technical services provided by Directive 2007/46/EC should be laid down in this Regulation in greater detail in order to ensure that they are applied consistently in all Member States. The assessment methods of the technical services in Member States have a tendency to differ progressively due to the increased complexity of their work. Therefore, it is necessary to provide for procedural obligations that ensure an exchange of information, and monitoring of Member States' practices for, the assessment, designation, notification and monitoring of their technical services. Those procedural obligations should remove any existing discrepancies in the methods used by, and in the interpretation of the criteria for the designation of, technical services. In order to ensure adequate oversight and a level playing-field across the Union, the assessment of an applicant technical service should include an on-site assessment.

(12) In the case of multi-stage type-approvals, it is essential to verify that changes made before the final stage of completion do not affect the functioning of type-approved systems, components or separate technical units in a way that would invalidate the type-approval previously granted.

(13) The need for control and monitoring of technical services has increased because technical progress has increased the risk of technical services not possessing the necessary competence to test new technologies or devices that emerge within their scope of designation. As technical progress shortens product cycles and as the intervals of surveillance on-site assessments and of the monitoring vary, the validity of the designation of technical services should be limited in time, which should ensure that the competence of technical services is periodically assessed.

(14) The designation and monitoring of technical services by the Member States, in accordance with detailed and strict criteria, should therefore be subject to supervisory controls, inter alia as a condition for the renewal of their designation. The position of technical services vis-à-vis manufacturers should be strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on automotive products covered by this Regulation, in order to ensure continuous compliance by manufacturers after they have obtained a type-approval for their automotive products.

(15) In order to increase transparency and mutual trust and to further align and develop the criteria for the assessment, designation, and notification of technical services, as well as extension and renewal procedures, Member States should cooperate with each other and with the Commission. Member States should consult each other and the Commission on questions with general relevance for the implementation of this Regulation and inform each other and the Commission. It is important that the Member States and the Commission use a common secure electronic exchange system as a means to facilitate and enhance administrative cooperation after appropriate implementation periods in order to make managing the exchange of information more efficient and effective on the basis of simple and unified procedures. In order to facilitate its accessibility and transparency, information should be available as structured data that is electronically searchable.

(16) Where designation of a technical service is based on accreditation within the meaning of Regulation (EC) No 765/2008 of the European Parliament and of the Council (4), accreditation bodies and designating approval authorities should exchange information relevant for the assessment of the competence of technical services.

(17) The Member States should have the possibility to levy fees for the designation and monitoring of technical services in order to ensure the sustainability of the monitoring of those technical services by Member States and to establish a level playing field for technical services.

(18) When, in spite of the measures taken by the Member States to ensure a coherent and continuing application of the requirements, the competence of a technical service is in doubt, the Commission should have the possibility to investigate individual cases.

(19) In order to ensure that tests and reports provided by technical services are not influenced by non-legitimate circumstances, it is important that the organisation and operation of technical services ensure full impartiality and independence. To be able to carry out their tasks in a coherent and systematic manner, technical services should have in place a satisfactory management system that includes provisions on professional secrecy. In order to allow technical services to perform their work properly, their personnel should always exhibit the appropriate level of knowledge, competence and independence.

(20) A robust compliance enforcement mechanism is necessary in order to ensure that the requirements under this Regulation are met. Ensuring compliance with the type-approval and conformity of production requirements of the legislation governing the automotive sector should remain the key responsibility of the approval authorities, as it is an obligation closely linked to the issuing of the type-approval and requires detailed knowledge of its content. It is therefore important that the performance of approval authorities is regularly verified.

(21) In order to ensure compliance with this Regulation, to ensure its uniform application within the Union and to facilitate an exchange of best practices, the Commission should organise and carry out assessments of the procedures set up by approval authorities in accordance with this Regulation. The outcome of such assessments, including any non-binding recommendations, should be discussed within the Forum. The assessments should be carried out periodically, taking into account the principle of proportionality, the number and variety of type-approvals granted and any instances of non-compliance discovered during the compliance verification.

(22) In order to ensure the effectiveness of the Commission's assessment while minimising the administrative burden, it is important that the approval authorities and the Commission cooperate efficiently during the assessment, in particular during the assessment at the premises of the approval authority concerned. The Commission assessments should be carried out in compliance with applicable law, complying, inter alia, with the working periods or language of the national authorities. The costs arising from those assessments should be borne by the Commission, including those related to document translation.

(23) The compliance verification system is being strengthened by the recognition of a formal process of accreditation of technical services or via the introduction of regular peer-evaluation in respect of the assessment and monitoring of technical services by approval authorities. This aims to ensure that a uniform level of quality and stringency is applied by all approval authorities in enforcing the type-approval requirements.

(24) Closer coordination between national authorities through information exchange and coordinated assessments under the direction of a coordinating authority is fundamental in order to ensure a consistently high level of safety and of health and environmental protection within the internal market. It would also lead to more efficient use of scarce resources at national level. For this purpose, an advisory Forum should be established for Member States and the Commission with the objective of promoting best practices, exchanging information and coordinating activities related to the enforcement of type-approval legislation. The currently informal cooperation between Member States in that respect would benefit from a more formal framework. The Forum should be composed of representatives appointed by the Member States representing their approval authorities and market surveillance authorities. The representatives attending a given meeting should be selected on the basis of the issues discussed by the Forum. In order to benefit from a range of views and inputs, it is useful for particular outside observers to be invited on a regular basis to the Forum, whenever those observers' activities are relevant to the issues to be discussed.

(25) In order to avoid potential conflicts of interest, approval authorities and market surveillance authorities should not be linked when carrying out their tasks. Where a Member State chooses to place those authorities within the same organisation, it should at least ensure that that organisation has structures that ensure that the activities of the authorities remain distinct from one another in terms of their direct management and decision-making.

(26) The rules on Union market surveillance and on the control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to motor vehicles and their trailers, as well as to systems, components and separate technical units intended for such vehicles. Those rules do not prevent Member States from choosing the competent authorities that are to carry out those tasks. Market surveillance is a competence that may be shared between different national authorities, in order to take account of the national market surveillance systems in the Member States established under Regulation (EC) No 765/2008. Effective coordination and monitoring at Union and national levels should guarantee that approval authorities and market surveillance authorities enforce the new framework for type-approval and for market surveillance.

(27) It is necessary to include rules on market surveillance in this Regulation in order to reinforce the rights and obligations of the national authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.

(28) It is necessary for the market surveillance authorities and the approval authorities to be able to properly perform the tasks provided for by this Regulation. Member States should, in particular, equip them with the resources necessary in order to do so.

(29) In order to increase transparency in the approval process and to facilitate the exchange of information and the independent verification by market surveillance authorities, approval authorities and the Commission, type-approval documentation should be provided in electronic format and be made publicly available, subject to exemptions concerning the protection of commercial secrets and the protection of personal data.

(30) The obligations of national authorities concerning market surveillance provided in this Regulation are more specific than those laid down in Regulation (EC) No 765/2008. This is the result of the need to take account of the special characteristics of the framework for type-approval and the need to complement that framework with an effective market surveillance mechanism ensuring the robust verification of compliance of the automotive products covered by this Regulation. In order to ensure the functioning of the framework, it is essential that market surveillance authorities verify compliance of the automotive products irrespective of whether their type-approval was granted before or after the date of application of this Regulation.

(31) It is essential for the proper functioning of market surveillance that the compliance of vehicles, systems, components and separate technical units on the market is verified on the basis of a robust risk-assessment. That verification of compliance, complemented by the establishment of a minimum number of checks on vehicles per year, would also contribute to the effective Union-wide implementation of the market surveillance obligations.

(32) In view of the special characteristics of, and the potential risk linked to, emissions, an adequate share of the minimum number of checks should be allocated to emission-related tests. In order to ensure that vehicles comply fully, each single check should include verification that all the requirements for type-approval that apply to the vehicle being tested as regards emissions have been met.

(33) It should be possible to use any tests carried out on any vehicle in any Member State for the purpose of taking corrective and restrictive measure in another Member State. The results of checks performed on vehicles within one Member State should be considered adequate for the purpose of invoking corrective and restrictive measures in another Member State. The physical transportation of the vehicles concerned should not, therefore, be necessary for the purpose of any checks which are carried out on behalf of another Member State.

(34) It is of particular importance that national authorities and the Commission consider in-service conformity testing and inspections of vehicles to be part of their compliance verification procedures. The selection of the vehicles that are to be subject to that compliance verification should be based on an appropriate risk assessment which takes account of the seriousness of the possible non-compliance; the likelihood of its occurrence; and other possible indicators, such as the introduction of vehicles with new technology installed, any past history or reports of non-compliance, the results of remote sensing testing and the concerns expressed by recognised third parties.

(35) In addition, in order to verify compliance with the relevant requirements, the Commission should organise and carry out compliance verification tests and inspections that are independent of those carried out by Member States under their national market surveillance obligations. Where such tests and inspections take place on registered vehicles in agreement with the holder of the vehicle registration certificate, it is important to take into account the fact that modified vehicles might be unsuited to such verification of compliance. It is also important to take into account the implications for the holder of the vehicle registration certificate, especially where the holder is a natural person, in the case of which the suitable way of selecting the vehicles is either by way of a public call or through the Member States' authorities. Where those tests and inspections establish non-compliance, or where it is found that a type-approval has been granted on the basis of incorrect data, the Commission should be entitled to initiate Union-wide remedial actions to restore the conformity of the vehicles concerned, and to investigate the reasons why the type-approval was incorrect. Appropriate funding should be ensured in the general budget of the Union to enable the execution of such compliance verification tests and inspections.

(36) In order to support Member States in the task of detecting defeat devices, the Commission published, on 26 January 2017, Guidance on the evaluation of Auxiliary Emission Strategies and the presence of Defeat Devices with regard to the application of Regulation (EC) No 715/2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6). Consistent with that Guidance, the test activities of the Commission, of the type-approval authorities and of the technical services for the purpose of detecting defeat devices should remain non-predictable in character, and should also include modified testing conditions which entail variations in physical conditions and testing parameters.

(37) In order to ensure a high level of vehicle functional safety, to ensure the protection of vehicle's occupants and other road users, and to ensure the protection of the environment and health, the technical requirements and environmental standards that apply to vehicles, systems, components and separate technical units should continue to be harmonised and adapted to reflect the technical and scientific progress.

(38) The objective of this Regulation should not be affected by the fact that certain systems, components, separate technical units, parts and equipment can be fitted to or in a vehicle after that vehicle has been placed on the market, has been registered or has entered into service. Appropriate measures should therefore be taken to ensure that the systems, components, separate technical units or parts and equipment that can be fitted to or in vehicles and that can significantly impair the functioning of systems that are essential for environmental protection or functional safety are subject to controls by an approval authority before they are placed on the market, registered or entered into service.

(39) Those measures should only apply to a limited number of parts or equipment. In the event of serious risk, the Commission should establish the list of such parts or equipment and the corresponding requirements as a matter of priority, after having consulted stakeholders. In establishing the list, the Commission should ensure in particular that replacement parts and equipment that are essential for emission controls and safety meet the performance specifications of the original parts and equipment. It should also consult stakeholders on the basis of a report, and should strive for a fair balance between the requirements of improving road safety and environmental protection, as well as a fair balance between the interests of consumers, manufacturers and distributors while preserving competition in the aftermarket.

(40) The EU type-approval system has to enable each Member State to confirm that every type of vehicle and every type of system, component and separate technical unit intended for such type of vehicle has undergone the tests and inspections provided for in this Regulation to verify its compliance with the type-approval requirements of this Regulation and that its manufacturer has obtained a type-approval certificate for it. The EU type-approval system obliges manufacturers to produce their vehicles, systems, components and separate technical units in conformity with the approved type. A vehicle manufacturer has to certify this by issuing a certificate of conformity for every vehicle. Every vehicle which has a valid certificate of conformity should be permitted to be made available on the market and registered in the Union.

(41) In order to simplify the exchange of information related to type-approval between the competent authorities and to make relevant information publically accessible after appropriate implementation periods, the use of searchable online databases should be compulsory. To preserve confidential data, it is important for all data exchange to be performed by means of secure data exchange protocols. Special attention should be paid to eliminating data misuse, including avoidance of creating multiple first time registrations when using certificates of conformity in electronic format.

(42) Conformity of production is one of the cornerstones of the EU type-approval system, and therefore the arrangements set up by the manufacturer to ensure such conformity should be approved by the competent authority or by an appropriately qualified technical service designated for that purpose, and should be subject to regular verification by means of independent periodic audits. In addition, approval authorities should ensure the verification of the continued conformity of the automotive products concerned.

(43) The continued validity of the type-approvals requires that the manufacturer inform the authority that has approved its type of vehicle of any changes to the characteristics of the type or to the safety and environmental performance requirements applicable to that type so that it can be verified that the type of vehicle continues to comply with all the applicable requirements. Furthermore, the conditions for amending type-approvals should be clarified to ensure the uniform application of the procedures and the enforcement of the type-approval requirements throughout the Union, in particular to ensure the strict application of the rules that distinguish between amended type-approvals and new type-approvals. To ensure that the latest requirements are implemented on all new vehicles at a certain point in time, it is important that regulatory acts listed in Annex II include not only a date for the application of new requirements to new type-approvals, but also a date as of which new requirements become mandatory for the making available on the market, registration or entry into service of vehicles, systems, components or separate technical units.

(44) The assessment of reported serious risk to safety and of harm to public health and the environment should be conducted at national level, but coordination at Union level should be ensured where a reported risk or harm may extend beyond the territory of one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective actions to be taken to mitigate the identified risk or harm.

(45) In order to ensure that all vehicles, systems, components and separate technical units placed on the market offer a high level of safety and of environmental protection, the manufacturer or any other economic operator in the supply chain should take appropriate corrective measures, including recalling vehicles, where a vehicle, system, component or separate technical unit presents a serious risk to users or the environment as provided for in Regulation (EC) No 765/2008. Approval authorities should be empowered to assess and verify whether those corrective measures are adequate. The approval authorities of other Member States' should have the right to take corrective and restrictive measures where they consider that the manufacturer's corrective measures are not adequate.

(46) Where corrective measures are applied, holders of registrations for affected vehicles should not bear the cost of the repairs to their vehicles, including in cases where repairs have been carried out at the registration holder's expense before the adoption of the corrective measure. This should not prevent consumers relying on remedies based on contract law, as applicable under Union or national law.

(47) Appropriate flexibility should be provided by means of alternative approval schemes for manufacturers of vehicles produced in small series. They should be able to benefit from the advantages of the internal market, provided that their vehicles comply with the specific EU type-approval requirements for vehicles produced in small series. In certain limited cases, it is appropriate to allow for national small series type-approval. In order to prevent misuse, any simplified procedure for vehicles produced in small series should be restricted to cases involving very limited production in accordance with this Regulation. It is therefore necessary to precisely define the concept of vehicles produced in small series in terms of the number of vehicles produced, the requirements to be complied with and the conditions for placing those vehicles on the market. It is equally important to specify an alternative approval scheme for individual vehicles, in particular to provide sufficient flexibility for the approval of vehicles built in multiple stages.

(48) The Union is a Contracting Party to the Agreement of the United Nations Economic Commission for Europe of 20 March 1958 concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (‘Revised 1958 Agreement’) (5). The Union has accepted a significant number of Regulations annexed to the Revised 1958 Agreement, and therefore has the obligation to accept type-approvals granted in accordance with those Regulations as complying with the equivalent Union requirements. For the purpose of simplifying its framework for type-approval and aligning it with the international framework of the United Nations (UN), in Regulation (EC) No 661/2009 of the European Parliament and of the Council (6), the Union repealed its specific type-approval Directives and replaced them with the obligatory application of the relevant UN Regulations. To reduce the administrative burden of the type-approval process, where appropriate, manufacturers of vehicles, systems, components and separate technical units should be allowed to seek type-approval directly in accordance with this Regulation by obtaining approval under the relevant UN Regulations referred to in the Annexes to this Regulation.

(49) Consequently, the UN Regulations and the amendments thereto which the Union has voted in favour of or that the Union applies in accordance with Decision 97/836/EC should be incorporated within the EU type-approval legislation. Accordingly, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes to this Regulation to ensure that the references to the UN Regulations and their respective amendments in the list of the relevant regulatory acts are kept up-to-date.

(50) Unrestricted access to vehicle repair and maintenance information, via a standardised format that can be used to retrieve the technical information, and effective competition in the market for services providing such information, are necessary to improve the functioning of the internal market, in particular as regards the free movement of goods, the freedom of establishment and the freedom to provide services. The requirements for the provision of repair and maintenance information have so far been laid down in Regulations (EC) No 715/2007 (7) and (EC) No 595/2009 (8) of the European Parliament and of the Council. Those requirements should be consolidated in this Regulation and Regulations (EC) No 715/2007 and (EC) No 595/2009 should be amended accordingly.

(51) Technical progress introducing new methods or techniques for vehicle diagnostics and repair, such as remote access to vehicle information and software, should not weaken the objective of this Regulation with respect to access to vehicle repair and maintenance information for independent operators.

(52) In order to ensure effective competition in the market for vehicle repair and maintenance information services, and in order to clarify that the information concerned also covers information which needs to be provided to independent operators other than repairers, so as to ensure that the independent vehicle repair and maintenance market as a whole can compete with authorised dealers, regardless of whether the vehicle manufacturer gives such information to authorised dealers and repairers or uses such information for the repair and maintenance purposes itself, it is necessary to set out the details of the information to be provided for the purposes of access to vehicle repair and maintenance information.

(53) For the inspection of vehicles, and in particular for their safety- and environment- related components, it is considered to be necessary for testing centres and relevant competent authorities to have access to the technical information of each individual vehicle, as set out in Directive 2014/45/EU of the European Parliament and of the Council (9). In order to facilitate compliance with the requirements laid down in that Directive, the independent operators should have access to the relevant technical information needed for the preparation of vehicles for road worthiness tests.

(54) Since there is currently no common structured process for the exchange of vehicle component data between vehicle manufacturers and independent operators, it is appropriate to develop principles for such exchanges of data. A future common structured process on the standardised format of the exchanges of data should be formally developed by the European Committee for Standardisation (CEN), although the mandate given to CEN does not predetermine the level of detail that standard will provide. The CEN's work should, in particular, reflect the interests and needs of vehicle manufacturers and independent operators alike and should also investigate solutions such as open data formats described by well-defined meta-data to accommodate existing information technology infrastructures.

(55) In order to ensure the effectiveness of this Regulation, the power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in respect of type-approval requirements concerning the environmental and safety performance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (10). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(56) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11).

(57) Member States should lay down rules on penalties for the infringements of this Regulation, and should ensure that those rules are implemented. Those penalties should be effective, proportionate and dissuasive. In particular, they should reflect, the risk to safety, health or the environment that the number of non-compliant vehicles, systems, components or separate technical units made available on the market could pose. Member States should report the imposed penalties to the Commission annually, to monitor the coherence of the implementation of those rules.

(58) When performing compliance verification testing, technical services should be able to choose the parameters of the tests freely and in a non-predictable manner from within the range provided for in the relevant regulatory acts. This should help them verify that the vehicles tested are compliant across the whole range of parameters, including the parameters that correspond to the worst case for the test.

(59) In order to ensure that the vehicles, systems, components and separate technical units comply with this Regulation in all cases, they should be deemed not to comply with the relevant requirements where test results cannot be empirically verified by the relevant authority even though all testing parameters have been replicated or taken into account. It is necessary to impose penalties on economic operators and technical services who falsify test results or submit false declarations or incorrect data for type-approval.

(60) In the interests of clarity, rationality and simplification, Directive 2007/46/EC should be repealed and replaced by this Regulation. The adoption of this Regulation ensures that provisions are directly applicable and that they can be updated in a timely and more efficient manner to take better account of technical progress and regulatory developments in the context of the Revised 1958 Agreement.

(61) In order to support corrective and restrictive measures at Union level, the Commission should have the power to impose harmonised administrative fines upon the economic operators found to have infringed upon this Regulation regardless of where a vehicle, system, component or separate technical unit was originally type-approved. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement this Regulation by laying down the procedure for, and methods for calculation and collection of, those administrative fines, on the basis of the principles laid down in this Regulation.

(62) Whenever the measures provided for in this Regulation entail the processing of personal data, they should be carried out in accordance with Regulations (EU) 2016/679 (12) and (EC) No 45/2001 (13) of the European Parliament and of the Council as well as the national implementing measures thereto. It is important that manufacturers implement all measures necessary to comply with the rules on processing and transmission of personal data that are generated while the vehicle is used.

(63) In order to enable Member States and national authorities as well as economic operators to prepare for the application of the new rules introduced by this Regulation, a date of application falling after the date of the entry into force should be set.

(64) Since the objective of this Regulation, namely laying down administrative provisions and technical requirements for the type-approval of new vehicles of categories M, N and O, and for the type-approval of systems, components and separate technical units intended for such vehicles, as well as for the market surveillance of such vehicles, systems, components and separate technical units, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

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 (14);

(b) two- or three-wheel vehicles and quadricycles, as defined in Regulation (EU) No 168/2013 of the European Parliament and of the Council (15);

(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 (16).

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 (17).

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 (18) 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 ri