EUROPEAN COMMISSION Brussels, 27.1.2016 COM(2016) 31 final 2016/0014(COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Text with EEA relevance) {SWD(2016) 9 final}

{SWD(2016) 10 final}



EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL 1.1.Grounds for and objectives of the proposal The legal framework for the type-approval of automotive products covers three categories of vehicles: motor vehicles and their trailers, motorcycles, and tractors. The objective of this proposal is to revise the legal framework for the type-approval of motor vehicles and their trailers. The legal framework for the two other vehicle categories has already been the subject of a major revision in 2013. Type-approval requirements for motor vehicles and their trailers are currently set out in Directive 2007/46/EC of the European Parliament and of the Council (the ‘Framework Directive’). This framework aims at facilitating the free movement of motor vehicles and trailers in the internal market by laying down harmonised requirements designed to achieve common environmental and safety objectives. Directive 2007/46/EC covers motor vehicles for the carriage of passengers (category M) and of goods (category N), and their trailers (category O), as well as their systems and components. It provides a framework under which separate regulatory acts with specific safety and environmental requirements are operating. These regulatory acts deal with a multitude of detailed technical requirements for different types of vehicles, systems and components. As part of the commitments the Commission made in its CARS2020 Action Plan for a strong, competitive and sustainable European car industry, the EU type-approval framework for motor vehicles has been the subject of a comprehensive fitness check in 2013. It confirmed that the EU type-approval legal framework is appropriate for achieving the main goals of harmonisation, effective operation of the internal market and fair competition. However, it was also recognised that differences in interpretation and strictness in application of the requirements across Member States are reducing the effectiveness of the framework. The Commission Staff Working document on this Fitness Check therefore acknowledged room for improvement and singled out the review of Directive 2007/46/EC as a matter of priority, with the need to focus on the following aspects: –introduction of market surveillance provisions to complement the type-approval requirements; –clarification of the recall and safeguard procedures, as well as the conditions for granting extensions to approvals for existing types of vehicle; –improving the enforcement of the type-approval framework by harmonising and enhancing the type-approval and conformity of production procedures applied by Member State authorities and technical services; –clarification of the roles and responsibilities of economic operators in the supply chain, and of the authorities and parties involved in the enforcement of the framework; and –improving the suitability of alternative type-approval schemes (national small series and individual approvals) and of the multi-stage type-approval process to provide appropriate flexibility for niche markets and SMEs, without however distorting the level playing field. Although the fitness check confirmed that the existing regulatory framework has its merits in meeting policy objectives, it has come under harsh criticism after the discovery that a German manufacturer (VW) had for several years used software to manipulate the emission performance of its cars. Within a week of the outbreak of the scandal, the Commission announced that it would reinforce the type-approval system, in particular by ensuring adequate supervisory mechanisms to ensure a correct and harmonised application of the type-approval procedures. In an internal market with 28 Member States and in a sector subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules entail the risk of undermining the effectiveness of the system and therefore the main policy objectives of ensuring the safety and health of citizens and the protection of the environment. Many stakeholders openly called for such a revision in the aftermath of the VW scandal. This revision aims to overcome these flaws and gaps and to restore the citizen's trust in the capability of the regulatory system to ensure an adequate level of protection of health and the environment. 1.2.Existing provisions in the area of the proposal –Directive 2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and technical units intended for such vehicles. –Regulation 765/2008/EC on accreditation and market surveillance, containing rules for the European policy on accreditation (control of the competence of laboratories and certification/inspection bodies delivering certificates in the EU) and for the policy in the field of market surveillance and controls of products from third countries (for safe products whatever their origin). –Decision 768/2008/EC establishing a common framework for the marketing of products, containing standard provisions to be used in EU internal market legislation for products (e.g. definitions, obligations of economic operators, safeguard clause, etc.). 2.RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS The European Commission launched a public consultation in 2010, seeking to gather the views of interested parties on its intention to revise the framework directive. The aim of this public consultation was to verify whether the areas identified by the Commission services as having a potential for improving the enforcement of EU type-approval legislation for motor vehicles would provide the right scope and focus for the envisaged review of Framework Directive 2007/46/EC.

Forty relevant responses were received which, overall, indicated a strong support for the aims of the initiative. Whilst 74% of the respondents concurred that the current type-approval framework was already of fairly high quality, 57.6% of them considered that nonetheless more could be done to emphasise and properly focus the legal application of market surveillance principles, with 47% of respondents saying that existing market surveillance provisions are ineffective, while just 2.9% agreed it was effective. This outcome clearly demonstrated that stakeholders share the view that more can and should be done to complement the ex-ante controls offered by the type-approval framework with ex-post market surveillance provisions. The Commission services also commissioned a number of external studies to accompany and feed in to the Impact Assessment process. An ex-post evaluation study on the framework directive was carried out in the first half of 2011, followed by an impact assessment (IA) study in the second half of 2011. This study assessed the impact of the possible options developed for each of the needs identified by the Commission services and which were confirmed to be relevant by the public consultation. Based on the results of the public consultation and the IA study, a preferred combination of policy options for addressing these needs has been identified. Further work on the preparation of the impact assessment and the review of the Framework Directive was undertaken in 2012/2013 by means of a fitness check pilot project. A study contract has been awarded for that purpose which was finalised in March 2013. A Commission Staff working document reporting on the outcome of the fitness check pilot project was published in November 2013, highlighting the priorities for the envisaged revision of Directive 2007/46/EC (See point 1.1 above). High level involvement of stakeholders has taken place in the context of the CARS 21 High Level Group, resulting in a number of recommendations in relation to the type-approval framework that have been taken up by the Commission in its CARS 2020 Action Plan adopted in November 2012. Finally, and in line with the commitments the European Commission made in its CARS 2020 Action Plan, a competitiveness proofing study has been carried out in the second half of 2013 to complement the above mentioned actions. The need for mitigating measures for SMEs has been considered in the context of this study, which demonstrated that for the combination of policy options retained there would not be any significant impacts for the SMEs in the sector to the extent that they would require mitigating measures. In addition, specific exchanges with Member States' authorities have taken place during the entire impact assessment process at meetings of the Technical Committee Motor Vehicles (TCMV) and the Type-Approval Authorities Experts Group (TAAEG). Exchange of views with industry and user associations about the initiative have taken place in the framework for the Motor Vehicles Working Group (MVWG). All interested stakeholders have also been consulted by the external study contractors for the collection of data and views. Triggered by the outburst of the VW emissions scandal, the European Parliament adopted on 5 October 2015 a Resolution on emission measurements in the automotive sector, calling on the Commission for significantly strengthening the current EU type approval regime including more EU oversight, in particular with regard to market surveillance, coordination and follow up regime for vehicles sold in the Union. 3.LEGAL ELEMENTS OF THE PROPOSAL 3.1.Legal basis The legal basis of the proposal is Article 114 of the Treaty on the Functioning of the European Union (TFEU). 3.2.Subsidiarity principle The framework legislation for the type-approval of motor vehicles contributes to the implementation of the internal market for goods. This proposal envisages at rendering the implementation and enforcement of this legislation more effective as part of the overall policy objective to deepen the internal market strategy. Although Member States are responsible for the implementation of the legislation in their territory, ensuring a harmonised and co-ordinated approach based on commonly applicable criteria and uniformly applied by Member States is essential for maintaining a level playing field across the EU by means of a harmonised interpretation, implementation and enforcement of the type-approval requirements, and backed-up by harmonised provisions on market surveillance to provide Member States with adequate means for post-market controls and for taking effective and common remedial action against the presence of non-compliant and unsafe products on the market. The differences in the national organisation of type-approval and market surveillance in the Member States may give rise to a non-harmonised enforcement when viewed in the framework of the Union's Internal Market which no longer has internal borders and where controls at national borders have practically disappeared. To avoid that non-compliant products are placed on their territory, Member States also depend to a large extent on the effectiveness of the enforcement policy of their neighbours. Consequently, weaknesses in enforcement by one single Member State can seriously undermine the efforts taken by other Member States to prevent non-compliant products from entering their market. This interdependence is reinforced by the fact that the competence of enforcement authorities is limited to the national territory. Where remedial action is needed beyond the border, these authorities must rely on their colleagues in other Member States. This is due to fact that the type-approval framework is based on the principle that all new vehicles produced in conformity with a type of vehicle approved by one Member State benefit from the right of being freely marketed and registered in the other Member States. This right applies to all such vehicles, irrespective of their origin of production. This means that also vehicles produced outside the EU can be freely imported within the EU provided they the manufacturer has certified that they have been produced in compliance with a type of vehicle approved in one of the EU Member States. In view of the global nature of automotive sector, with substantial imports of automotive products from outside the EU, this important cross-border dimension calls for co-ordinated action at EU level to ensure a level playing field. If actions were to be taken individually by Member States at national level to address market problems, this may entail the risk of creating obstacles to the free movement of motor vehicles ensured by the framework legislation. Hence it is justified to take action at EU level. 3.3.Proportionality principle The proposal complies with the proportionality principle because it does not go beyond what is necessary in order to achieve the objectives of ensuring the proper functioning of the internal market while at the same time providing for a high level of public safety and environmental protection. The measures proposed to reinforce and further harmonise the implementation of the type-approval procedures are based on the agreed principles laid down in the common framework for the marketing of products, and on the reference provisions for Union harmonisation legislation for products as laid down in Annex I of Decision No 768/2008/EC. Where necessary and justified, these provisions have been adapted to the specificities of the automotive sector, in particular with the view to recognise the existence of an already well-established type-approval framework and to ensure full coherence with this framework. This has in particular the case for the provisions on the information exchange and co-operation between market surveillance authorities on the one hand and the type-approval authorities and their designated technical services on the other. 3.4.Choice of instruments

The use of a Regulation is considered to be appropriate in that it provides the required assurance for direct and harmonised application and enforcement while not requiring transposition into Member States’ legislation. The proposal continues to build on the ‘split-level approach’ already introduced in the EU type-approval framework for motor vehicles. This approach provides for legislation in three steps: –the fundamental provisions and scope are laid down by the European Parliament and the Council in a Regulation based on Article 114 TFEU in accordance with the ordinary legislative procedure. –the detailed technical specifications associated with the fundamental provisions will be laid down in delegated acts adopted by the Commission in accordance with Article 290 of the Treaty on the Functioning of the European Union. –implementing acts setting out the administrative provisions, such as the template for the information document and the type-approval certificates, the certificate of conformity, etc. will be adopted by the Commission in accordance with Article 291 of the Treaty on the Functioning of the European Union. 4.BUDGETARY IMPLICATION The budgetary implications of this proposal are as follows: Commission staff to organise and participate in 'joint assessments' of technical services; Costs for national assessors participating in 'joint assessments' of technical services in accordance with the Commission's rules on the reimbursement of expenses incurred by experts; Commission staff to provide scientific, technical and logistic support to the peer review system (joint audits of technical services)and to the coordination of Member States' market surveillance activities in the field of automotive products; Commission staff to manage and further develop the EU regulatory framework for the type-approval and market-surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (functioning of this Regulation and preparation of delegated/implementing acts) and to support and monitor Member States in ensuring its effective and efficient implementation; Costs for organising meetings of the Enforcement Forum laid down in Article 10, including reimbursement of the travel expenses of the Member States; Costs for the establishment and management of the supervisory mechanism in respect of conformity assessments carried out by technical services; Costs for running compliance and conformity testing of motor vehicles by the Commission and Costs for participation in international regulatory cooperation, in particular in UNECE; Details of the costs are set out in the legislative financial statement. In view of the constraints of the Multiannual Financial Framework 2014-2020 the implementation of the legislative proposal will have to be built on existing resources and to be designed in such a manner that additional financial resources under the EU budget are not needed. Actions foreseen in this draft proposal for a Regulation will have no budgetary impact on EU budget over and beyond the appropriations already foreseen in the official financial programming of the Commission as any requirements for financial resources would have to be met through assigned revenues and internal redeployment. For the period following 31 December 2020, the amount shall be subject to the multiannual financial framework in force for the period commencing in 2021, in accordance with Article 312 of the Treaty on the Functioning of the European Union. 5.OPTIONAL ELEMENTS 5.1.European Economic Area

The proposed act concerns matters relating to the European Economic Area (EEA) and should therefore be extended to the EEA. 5.2.Repeal of existing legislation The adoption of the proposal will lead to the repeal of existing legislation. 2016/0014 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (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, Acting in accordance with the ordinary legislative procedure, Whereas: (1)The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured. Internal market rules should be transparent, simple and consistent, thus providing legal certainty and clarity for the benefit of businesses and consumers. (2)To that end, a comprehensive EU type-approval framework for motor vehicles and their trailers, and of 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)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, carried out in 2013, showed that the framework established by Directive 2007/46/EC is appropriate for achieving the main goals of harmonisation, effective operation of the internal market and fair competition, and therefore should continue to apply. (4)In that assessment it was 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 type-approval framework by harmonising and enhancing the type-approval and conformity of production procedures applied by Member States' authorities and technical services, a need to clarify the roles and responsibilities of economic operators in the supply chain, and of the authorities and parties involved in the enforcement of the framework, and a need to improve the suitability of alternative type-approval schemes (national small series and individual vehicle approvals) and of the multi-stage type-approval process to provide appropriate flexibility for niche markets and SMEs, without however distorting the level playing field. (5)In addition, recent problems encountered with the implementation of the type-approval framework have revealed particular weaknesses and demonstrate the need for a fundamental revision to ensure a robust, transparent, predictable and sustainable regulatory framework that provides a high level of safety and of health and environmental protection.

(6)This Regulation sets out the 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 the individual vehicle approval, with a view to ensuring the proper functioning of the internal market for the benefit of businesses and consumers and to offer a high level of safety and protection of health and the environment. (7)This Regulation lays down the substantive technical and administrative type-approval requirements for motor vehicles of categories M and N and their trailers (category O), and for the systems, components and separate technical units intended for such vehicles with a view to ensuring an adequate level of safety and environmental performance. These categories cover motor vehicles for the carriage of passengers, motor vehicles for the carriage of goods, and their trailers, respectively. (8)This Regulation should strengthen the current type-approval framework, 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 or that do not comply with the type-approval requirements. (9)An effective implementation of the type-approval requirements should be ensured by enhancing the provisions on conformity of production by, inter alia, providing for mandatory periodic audits of the conformity control methods and the continued conformity of the 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 type-approval authorities . The proper functioning of technical services is crucial for ensuring a high level of safety and 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 greater detail in order to assure their consistent application. The assessment methods of technical services in the Member States have a tendency to progressively differ due to the increased complexity of their work. Therefore, it is necessary to provide for procedural obligations that ensure an information exchange 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 and in the interpretation of the criteria for the designation of technical services. (10)The need for control and monitoring of technical services by the designating authorities has increased since technical progress has raised the risk that technical services do not possess the necessary competence to test new technologies or devices emerging 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 between designating authorities, minimum requirements with regard to the intervals of the surveillance and monitoring of the technical services should be established. (11)Designation and monitoring of technical services by the Member States, in accordance with detailed and strict criteria, should therefore be subject to supervisory controls at Union level, including independent audits as a condition for the renewal of their notification after five years. 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 products covered by this Regulation, in order to ensure continuous compliance by manufacturers after they have obtained a type-approval for their products. (12)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. They 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 on their model assessment checklist. (13)Where designation of a technical service is based on accreditation in the meaning of Regulation (EC) No 765/2008 of the European Parliament and of the Council, accreditation bodies and designating authorities should exchange information relevant for the assessment of the competence of technical services. (14)The Member States should levy fees for the designation and monitoring of technical services to ensure sustainability of the monitoring of those technical services by Member States and to establish a level playing field for technical services. In order to ensure transparency, the Member States should inform the Commission and the other Member States before they adopt the level and structure of the fees. (15)When, in spite of the measures taken to ensure a coherent application and follow up of the requirements by the Member States, the competence of a technical service is in doubt, the Commission should have the possibility to investigate individual cases. (16)In order to ensure that tests and reports provided by technical services are not influenced by non-legitimate circumstances, the organisation and operation of technical services should ensure full impartiality. To be able to carry out their tasks in a coherent and systematic manner the technical services should possess a satisfactory management system including provisions on professional secrecy. In order to allow technical services to perform their work properly, the level of knowledge and competence and independence of their personnel should be guaranteed at all times. (17)The independence of technical services vis-à-vis manufacturers should be ensured, including by avoiding direct or indirect payments by the manufacturers for the type-approval inspections and tests they have carried out. Therefore the Member States should establish a type-approval fee structure that should cover the costs for carrying out all type-approval tests and inspections carried out by the technical services designated by the type-approval authority, as well as the administrative costs for issuing the type-approval and the costs for carrying out ex-post compliance verification tests and inspections. (18)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 by means of peer-reviews, to ensure that a uniform level of quality and stringency is applied by all approval authorities in enforcing the type-approval requirements. Moreover, it is important to provide for the verification of the correctness of the type approval itself. (19)Closer coordination between national authorities through information exchange and coordinated assessments under the direction of a coordinating authority is fundamental for ensuring a consistently high level of safety and health and environmental protection within the internal market. This should also lead to more efficient use of scarce resources at national level. For this purpose a Forum should be established for Member States and the Commission to exchange information on and to coordinate their activities related to the enforcement of type-approval legislation. The currently informal cooperation between Member States in this respect would benefit from a more formal framework. (20)The rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to motor vehicles and their trailers, and to systems, components and separate technical units intended for such vehicles without preventing Member States from choosing the competent authorities to carry out those tasks. Market surveillance may be a competence shared between different national authorities 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 and market surveillance authorities enforce the new type-approval and market surveillance framework. (21)It is necessary to include rules on market surveillance in this Regulation in order to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. (22)In order to increase transparency in the approval process and 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 due to protection of commercial interests and the protection of personal data. (23)The obligations of national authorities concerning market surveillance provided in this Regulation are more specific than those laid down in Article 19 of Regulation (EC) No 765/2008 to take account of the specificities of the type-approval framework and the need to complement that framework with an effective market surveillance mechanism ensuring a robust ex-post verification of compliance of the products covered by this Regulation. (24)Those more specific obligations for national authorities provided in this Regulation should include ex-post compliance verification testing and inspections of a sufficient number of vehicles placed on the market. The selection of the vehicles to be subject to this ex-post compliance verification should be based on an appropriate risk assessment which takes account of the seriousness of the possible non-compliance and the likelihood of its occurrence. (25)In addition, the Commission should organise and carry out or require to carry out ex-post compliance verification tests and inspections, independent from those carried out by Member States under their national market surveillance obligations. When non-compliance is established by those tests and inspections, 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 for the incorrectness of the type approval. Appropriate funding should be ensured in the general budget of the Union to enable the execution of such compliance verification testing and inspections. In view of the budgetary constraints of the Multiannual Financial Framework 2014-2020 the implementation of the legislative proposal will have to be built on existing resources and to be designed in such a manner that they do not generate additional financial resources. The Commission should be entitled to impose administrative fines where non-compliance is established.

(26)In order to ensure a high level of vehicle functional safety, the protection of vehicle's occupants and other road users, and environmental protection, the technical requirements and environmental standards applicable to vehicles, systems, components and separate technical units should continue to be harmonised and adapted to technical and scientific progress. (27)The objectives of this Regulation should not be affected by the fact that certain systems, components, separate technical units or parts and equipment can be fitted to or in a vehicle after that vehicle has been placed on the market, registered or 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 controlled by an approval authority before they are placed on the market, registered or entered into service. (28)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 a manufacturer to produce his 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 accompanied by a valid certificate of conformity should be permitted to be made available on the market and registered for use throughout the Union. (29)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 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 products concerned. (30)The continued validity of the type-approvals requires that the manufacturer informs the authority that has approved his type of vehicle about any changes to the characteristics of the type or the safety and environmental performance requirements applicable to that type. It is therefore important that the validity of issued type-approval certificates is limited in time and that those certificates can only be renewed when the approval authority has verified and is satisfied that the type of vehicle continues to comply with all the applicable requirements. Furthermore, the conditions for extending type-approvals should be clarified to ensure a uniform application of the procedures and enforcement of the type-approval requirements throughout the Union. (31)The assessment of reported serious risks 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 the reported risk or harm may exist beyond the territory of one Member State with the objective of sharing resources and ensuring consistency regarding the corrective action to be taken to mitigate the identified risk and harm. (32)In order to ensure that all vehicles, systems, components and separate technical units placed on the market offer a high level of safety and environmental protection, the manufacturer or any other economic operator in the supply chain should take effective corrective measures, including the recall of vehicles, where a vehicle, system, component or separate technical unit presents a serious risk for users or the environment as referred to in Article 20 of Regulation (EC) No 765/2008. Approval authorities should be empowered to assess and verify whether those measures are sufficient. The authorities of other Member States' should have the right to take safeguard measures in case they would consider that the manufacturer's corrective measures are not sufficient. (33)Appropriate flexibility should be provided by means of alternative type-approval schemes for manufacturers who produce vehicles in small series. They should be able to benefit from the advantages of the Union 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 of very limited production. It is therefore necessary to define precisely 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. (34)The Union is a contracting party to the Agreement of the United Nations Economic Commission for Europe (UNECE) 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’). The Union has accepted a significant number of regulations annexed to the Revised 1958 Agreement and has therefore the obligation to accept type-approvals issued in accordance with those regulations, as complying with the equivalent Union requirements. For the purpose of simplifying its type-approval framework and aligning it with the international framework of the UNECE, the Union in Regulation (EC) No 661/2009 of the European Parliament and of the Council repealed its specific type-approval Directives and replaced them with the obligatory application of the relevant UNECE regulations. To reduce the administrative burden of the type-approval process, manufacturers of vehicles, systems, components and separate technical units should be allowed to seek type-approval in accordance with this Regulation, where appropriate, directly by means of obtaining approval under the relevant UNECE regulations referred to in the Annexes to this Regulation. (35)Consequently, UNECE regulations and the amendments thereto which the Union has voted in favour of or that the Union applies, in accordance with Council Decision 97/836/EC, should be incorporated within the EU type-approval legislation. Accordingly, the power should be delegated to the Commission to amend the Annexes to this Regulation and to adopt delegated acts to ensure that the references to the UNECE regulations and their respective amendments in the list of the relevant regulatory acts are kept up-to-date. (36)Unrestricted access to vehicle repair and maintenance information, via a standardised format that can be used to retrieve the technical information, and effective competition on the market for services providing such information is necessary to improve the functioning of the internal market, particularly 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 Regulation (EC) No 715/2007 of the European Parliament and of the Council, Regulation (EC) No 595/2009 of the European Parliament and of the Council, Commission Regulation (EU) No 692/2008 and Commission Regulation (EU) No 582/2011. Those requirements should be consolidated in this Regulation and Regulations (EC) No 715/2007, (EC) No 595/2009, (EU) No 692/2008 and (EU) No 582/2011 should be amended accordingly. (37)Whereas 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 objectives of this Regulation with respect to access to repair and maintenance information for independent operators. (38)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. (39)In order to supplement this Regulation with further technical details, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union 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 for such vehicles. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (40)Member States should lay down rules on penalties for the infringements of this Regulation and ensure that those rules are implemented. Those penalties should be effective, proportionate and dissuasive. Member States shall report the imposed penalties to the Commission annually, to monitor the coherence of the implementation of these provisions. (41)In the interests of clarity, rationality and simplification, Directive 2007/46/EC should be repealed and replaced by this Regulation. The adoption of a 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. (42)In order to properly implement the compliance verification by the Commission and to ensure a level playing field for economic operators and national authorities, the Commission should be competent to impose harmonized administrative fines upon the economic operators found to have infringed upon this regulation regardless of where the vehicle, system, component or separate technical unit was originally type-approved. (43)Whenever the measures provided for in this Regulation entail the processing of personal data, they should be carried out in accordance with Directive 95/46/EC of the European Parliament and of the Council and Regulation (EC) No 45/2001 of the European Parliament and of the Council, as well as the national implementing measures thereto. (44)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 the act, an application date following the entry into force should be set. (45)Since the objectives of this Regulation, namely to lay down harmonised rules on the administrative and technical requirements for the type-approval of vehicles of categories M, N and O, and of systems, components and separate technical units, and on 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 their 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 those objectives,

HAVE ADOPTED THIS REGULATION: CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1

Subject matter 1.This Regulation establishes 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 intended for such vehicles referred to in Article 2(1). It also applies to individual vehicle approvals. 2.This Regulation establishes the requirements for the market surveillance of vehicles, systems, components and separate technical units that are subject to approval in accordance with this Regulation, as well as of parts and equipment for such vehicles. Article 2

Scope 1.This Regulation shall apply 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 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; (b)two- or three-wheel vehicles and quadricycles, as defined in Regulation (EU) No 168/2013 of the European Parliament and of the Council; (c)vehicles that are used on tracks. 3.For the following vehicles and machinery, the manufacturer may apply for type-approval or individual vehicle approval under this Regulation, provided that those vehicles fulfil the substantive 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 for use by the armed services, civil defence, 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. 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, the following definitions shall apply:

(1)‘type-approval’ means the procedure whereby a type-approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements; (2)‘market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles, systems, components or separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant Union legislation and do not endanger health, safety or any other aspect of public interest protection; (3)‘vehicle’ means any motor vehicle or its trailer as defined in points (10) and (11); (4)‘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 IV; (5)‘component’ means a device that is intended to be part of a vehicle and that may be type-approved independently of that vehicle and that is subject to the requirements of this Regulation or any of the regulatory acts listed in Annex IV; (6)‘separate technical unit’ means a device intended to be part of a vehicle that may 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 IV; (7)‘parts’ means goods used for the assembly, repair and maintenance of a vehicle as well as spare parts; (8)‘equipment’ means goods other than parts that can be added to or installed on a vehicle; (9)‘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 that person is or is not directly involved in all stages of the design and construction of that vehicle, system, component or separate technical unit concerned; (10)‘motor vehicle’ means any power-driven vehicle designed and constructed to be moved by its own means, having at least four wheels, being complete, completed or incomplete, with a maximum design speed exceeding 25 km/h; (11)‘trailer’ means any non-self-propelled vehicle on wheels designed and constructed to be towed by a motor vehicle; (12)‘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, 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 obligations regarding the conformity of production of the manufacturer are met; (13)‘market surveillance authority’ means the national authority or authorities responsible for carrying out market surveillance on the territory of the Member State; (14)‘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 and parts or equipment; (15)‘placing on the market’ means making available a vehicle, system, component, separate technical unit, part or equipment for the first time in the Union; (16)‘registration’ means the permanent or temporary administrative authorisation for the entry into service in road traffic of a vehicle, including the identification of the vehicle and the issuing of a serial number; (17)‘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; (18)‘economic operator’ means the manufacturer, the manufacturer’s representative, the importer or the distributor; (19)‘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; (20)‘multi-stage type-approval’ means the procedure whereby one or more approval authorities certify that depending on the state of completion, an incomplete or completed type of vehicle satisfies the relevant administrative provisions and technical requirements;

(21)‘incomplete vehicle’ means any vehicle that requires at least one further stage of completion in order to meet the relevant technical requirements of this Regulation and of the regulatory acts listed in Annex IV; (22)‘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 and of the regulatory acts listed in Annex IV; (23)‘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; (24)‘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; (25)‘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; (26)‘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 national law of a Member State, the validity of such approval being restricted to the territory of that Member State; (27)‘certificate of conformity’ means the document set out in Annex IX, issued by the manufacturer, which certifies that a produced vehicle conforms to the approved type of vehicle; (28)‘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; (29)‘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; (30)‘step-by-step type-approval’ means the procedure consisting of the step-by-step collection of the whole set of EU type-approval certificates for the systems, components and separate technical units forming part of a vehicle, and which leads, at the final stage, to the whole-vehicle type-approval; (31)‘single-step type-approval’ means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit as a whole satisfies the relevant administrative provisions and technical requirements by means of a single operation; (32)‘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 approval of the whole vehicle, without the need to issue the EU type-approval certificates for those systems; (33)‘completed vehicle’ means a vehicle resulting from the multi-stage type-approval that meets the relevant technical requirements of this Regulation and of the regulatory acts listed in Annex IV; (34)‘complete vehicle’ means a vehicle that does not need to be completed in order to meet the relevant technical requirements of this Regulation and of the regulatory acts listed in Annex IV; (35)‘type of vehicle’ means a particular category of vehicles that shares at least the essential criteria specified in Part B of Annex II, and that may contain variants and versions as referred thereto; (36)‘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; (37)‘base vehicle’ means any vehicle that is used at the initial stage of a multi-stage type-approval; (38)‘system type-approval’ means the procedure whereby an approval authority certifies that a type of system satisfies the relevant administrative provisions and technical requirements; (39)‘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; (40)‘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;

(41)‘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 IV without requiring the use of a physical vehicle, system, component or separate technical unit; (42)‘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 and national individual vehicle approval; (43)‘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; (44)‘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 IV; (45)‘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; (46)‘vehicle repair and maintenance information’ means all information required for diagnosing, servicing, inspecting, periodic monitoring, repairing, re-programming or re-initialising of a vehicle as well as for the fitting on vehicles of parts and equipment, and that is provided by the manufacturer to his authorised dealers and repairers, including all subsequent amendments and supplements to that information; (47)‘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, including repairers, manufacturers or distributors of repair equipment, tools or spare parts, publishers of technical information, automobile clubs, roadside assistance operators, operators offering inspection and testing services, operators offering training for installers, manufacturers and repairers of equipment for alternative fuel vehicles; it also means authorised repairers, dealers or 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; (48)‘authorised repairer’ means a natural or legal person providing repair and maintenance services for vehicles operating within the manufacturer’s distribution system; (49)‘independent repairer’ means a natural or legal person providing repair and maintenance services for vehicles not operating within the manufacturer’s distribution system; (50)‘vehicle on-board diagnostic (OBD) information’ means the information relating to a system on board of a vehicle or that is connected to an engine and that has the capability of detecting a malfunction, and, where applicable, of indicating its occurrence by means of an alert system, of identifying the likely area of malfunction by means of information stored in a computer memory, and of communicating that information off-board; (51)‘vehicle produced in small series’ means a type of vehicle of which the number of units that is made available on the market, registered or entered into service does not exceed the quantitative annual limits laid down in Annex XII; (52)‘special purpose vehicle’ (SPV) means a vehicle of category M, N or O having specific technical features to perform a function that requires special arrangements or equipment; (53)‘Semi–trailer’ means a towed vehicle, in which the axle(s) is (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. (54)‘national accreditation body’ means the sole body in a Member State that performs accreditation with authority derived from the State, as laid down in Article 2(11) of Regulation (EC) No 765/2008; (55)‘on-site assessment’ means a verification by the type-approval authority in the premises of the technical service or of one of its subcontractors or subsidiaries; (56)‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken for the initial designation, nor the on-site assessment undertaken for the renewal of the designation; Article 4

Vehicle categories 1.For the purposes of this Regulation, the following vehicle categories shall apply: (a)Category M comprises motor vehicles designed and constructed primarily for the carriage of persons and their luggage, namely: (i)Category M1:motor vehicles comprising not more than eight seating positions in addition to the driver’s seating position and without space for standing passengers. The number of seating positions may be restricted to the driver’s seating position;

(ii)Category M2:motor vehicles comprising more than eight seating positions in addition to the driver’s seating position and having a maximum mass not exceeding 5 tonnes. These motor vehicles may have space for standing passengers; (iii)Category M3:motor vehicles comprising more than eight seating positions in addition to the driver’s seating position and having a maximum mass exceeding 5 tonnes. These motor vehicles may have space for standing passengers. (b)Category N comprises motor vehicles designed and constructed primarily for the carriage of goods, namely: (i)Category N1:motor vehicles having a maximum mass not exceeding 3,5 tonnes; (ii)Category N2:motor vehicles having a maximum mass exceeding 3,5 tonnes but not exceeding 12 tonnes; (iii)Category N3:motor vehicles having a maximum mass exceeding 12 tonnes. (c)Category O comprises trailers designed and constructed for the carriage of goods or of persons, as well as for the accommodation of persons, namely: (i)Category O1:trailers having a maximum mass not exceeding 0,75 tonnes; (ii)Category O2:trailers having a maximum mass exceeding 0,75 tonnes but not exceeding 3,5 tonnes; (iii)Category O3:trailers having a maximum mass exceeding 3,5 tonnes but not exceeding 10 tonnes; (iv)Category O4:trailers having a maximum mass exceeding 10 tonnes. 2.The criteria for the categorisation of vehicles, types of vehicle, variants and versions are specified in Annex II. The Commission shall be empowered to adopt delegated acts in accordance with Article 88 to amend Annex II concerning the categorisation of vehicle sub-categories, types of vehicle and types of bodywork in order to adapt it to technical progress. CHAPTER II

GENERAL OBLIGATIONS Article 5

General substantive requirements 1.Vehicles, systems, components and separate technical units shall comply with the requirements of the regulatory acts listed in Annex IV. 2.The Commission shall be empowered to adopt delegated acts in accordance with Article 88 to amend Annex IV to take account of technological and regulatory developments by introducing and updating references to regulatory acts containing 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 the approval authorities and the market surveillance authorities. Member States shall notify the Commission of the establishment and appointment of such authorities. That notification shall include the name of those authorities, their address, including their electronic address, and their competences. The Commission shall publish on its website a list and details of the approval authorities and the market surveillance authorities.

2.Member States shall permit the placing on the market, registration or entry into service of only those vehicles, systems, components and separate technical units that comply with the requirements set out in this Regulation. 3.Member States shall not prohibit, restrict or impede the placing on the market, registration or entry into service of vehicles, systems, components or separate technical units that comply with the requirements set out in this Regulation, except in the cases provided in Article 52. By way of derogation from that rule, Member States are not obliged to allow the placing on the market, registration or entry into service of vehicles that are type-approved in accordance with this Regulation, but exceed the harmonised dimensions laid down in Annex I to Council Directive 96/53/EC. 4.Member States shall organise and carry out market surveillance and controls of vehicles, systems, components or separate technical units entering the market, in accordance with Chapter III of Regulation (EC) No 765/2008. 5.Member States shall take the necessary measures to ensure that market surveillance authorities may, where they consider it necessary and justified, be entitled to enter the premises of economic operators and seize the necessary samples of vehicles, systems, components and separate technical units for the purposes of compliance testing. 6.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 other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public, in particular the number of type-approval granted and the identity of the corresponding manufacturers. 7.The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public. Article 7

Obligations of approval authorities 1.Approval authorities shall only approve such vehicles, systems, components or separate technical units that comply with the requirements of this Regulation. 2.Approval authorities shall carry out their duties independently and impartially. They shall observe confidentiality where necessary in order to protect commercial secrets, subject to the obligation of information laid down in Article 9(3) in order to protect the interests of users in the Union. 3.A Member State where more than one approval authority is responsible for vehicle approval including individual vehicle approval, shall designate a unique type approval authority responsible for the exchange of information with the approval authorities of the other Member States and for the obligations laid down in Chapter XV of this Regulation. Approval authorities within a Member State shall cooperate with each other by sharing information relevant to their role and functions. 4.Where an approval authority is informed in accordance with Articles 8(5), 9(5), 52(4) or 54, it shall take all necessary measures to review the approval granted and, where appropriate, correct or withdraw the approval depending on the reasons and the seriousness of the deviations demonstrated. 5.The Commission may adopt implementing acts to lay down the common criteria to appoint, review and assess the approval authorities at national level. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). Article 8

Obligations of market surveillance authorities 1.Market surveillance authorities shall perform regular checks to verify compliance of vehicles, systems, components and separate technical units with the requirements set out in this Regulation as well as with the correctness of the type approvals. Those checks shall be performed on an adequate scale, by means of documentary checks and real-drive and laboratory tests on the basis of statistically relevant samples. When doing so, market surveillance authorities shall take account of established principles of risk assessment, complaints and other information. 2.Market surveillance authorities shall require economic operators to make the documentation and information available as they consider necessary for the purpose of carrying out their activities. 3.For type-approved vehicles, systems, components and separate technical units, market surveillance authorities shall take due account of certificates of conformity presented by economic operators. 4.Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any vehicle, system, component and separate technical unit so as to prevent or reduce the risk of injury or other damage. Market surveillance authorities shall cooperate with economic operators regarding actions which could prevent or reduce risks caused by vehicles, systems, components and separate technical units made available by those operators.

5.Where the market surveillance authorities of one Member State decide to withdraw a vehicle, system, component and separate technical unit from the market in accordance with Article 49(5), they shall inform the economic operator concerned and where applicable the relevant approval authority. 6.Market surveillance authorities shall carry out their duties independently and impartially. They shall observe confidentiality where necessary in order to protect commercial secrets, subject to the obligation of information laid down in Article 9(3) to the fullest extent necessary in order to protect the interests of users in the European Union. 7.The Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. The Member State concerned shall make a summary of the results accessible to the public. 8.The market surveillance authorities of different Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof. Where appropriate, the market surveillance authorities shall agree on work-sharing and specialisation. 9.Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions. 10.The Commission may adopt implementing acts to lay down the criteria for setting out the scale, scope and frequency with which the compliance verification checks of samples taken referred to in paragraph 1 have to be performed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). Article 9

Compliance verification by the Commission and

enforcement co-ordination with Member States 1. The Commission shall organise and carry out, or require to be carried out, on an adequate scale, tests and inspections of vehicles, systems, components and separate technical units already made available on the market, with a view to verifying that those vehicles, systems, components and separate technical units conform to the type approvals and to applicable legislation as well as to ensure the correctness of the type approvals. Those tests and inspections may take place on new vehicles supplied by manufacturers or the economic operator as provided in paragraph 2 below. Those tests and inspections may also take place on registered vehicles in agreement with the vehicle registration holder. 2.Manufacturers holding type-approvals or the economic operators shall, upon request, supply to the Commission 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. Those vehicles, systems, components and separate technical units shall be supplied for testing at the time and place and for the period the Commission may require. 3.For the purpose of enabling the Commission to carry out the testing referred to in paragraphs 1 and 2, Member States shall make available to the Commission all data related to the type-approval of the vehicle, systems, components and separate technical units subject to compliance verification testing. Those data shall include at least the information included in the type-approval certificate and its attachments referred to Article 26(1). For vehicles approved in accordance with the step-by-step or multistage type-approval procedure, Member States shall also provide the Commission with the type-approval certificate and its attachments referred to in Article 26(1) for the underlying type-approvals of systems, components and separate technical units. 4.Vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties. The Commission shall adopt implementing acts in order to define the data to be made public and the conditions for such publication, subject to the protection of commercial secrets and the preservation of personal data pursuant to Union and national legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). 5.Where the Commission establishes that the vehicles tested or inspected do not comply with the type-approval requirements laid down in this Regulation or any of the regulatory acts listed in Annex IV or that the type approval has been granted on the basis of incorrect data, it shall require in accordance with Article 54(8) without delay the economic operator concerned to take all appropriate corrective measures to bring the vehicles in compliance with those requirements, or it shall take restrictive measures, either by requiring the economic operator to withdraw the vehicles concerned from the market, or to recall them within a reasonable period of time, depending on the seriousness of the established non-compliance. Where those tests and inspections put into question the correctness of the type approval itself, the Commission shall inform the approval authority or authorities concerned as well as the Forum for Exchange of Information on Enforcement. The Commission shall publish a report of its findings following any compliance verification testing it has carried out. Article 10

Forum for Exchange of Information on Enforcement 1.The Commission shall establish and chair a Forum for Exchange of Information on Enforcement (‘the Forum’). This Forum shall be composed of members appointed by the Member States.

2.The Forum shall coordinate a network of the national authorities responsible for the type-approval and market surveillance. Its advisory tasks shall comprise inter alia the promotion of good practices, the exchange of information on enforcement problems, cooperation, development of working methods and tools, development of an electronic information exchange procedure, evaluation of harmonised enforcement projects, penalties and joint inspections. 3.The Commission shall be empowered to adopt delegated acts in accordance with Article 88 to lay down the composition, appointment process, detailed tasks, working methods and rules of procedure of the Forum. Article 11

General obligations of manufacturers 1.The manufacturer shall ensure that the vehicles, systems, components or separate technical units that he has manufactured and that have been placed on the market, or entered into service have been manufactured and approved in accordance with the requirements set out in this Regulation. 2.In the case of multi-stage type-approval, the manufacturer shall also be responsible for the approval and conformity of production of the systems, components or separate technical units that he has added at the stage of vehicle completion. Any manufacturer who modifies components, systems or separate technical units already approved at earlier stages shall be responsible for the approval and conformity of production of the modified components, systems or separate technical units. The manufacturer of the previous stage shall provide information to the manufacturer 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 issued and at the latest on the starting date of production of the incomplete vehicle. 3.The manufacturer who modifies 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, 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 representative appointed for the purposes of EU type-approval. 5.The manufacturer shall be responsible to the approval authority for all aspects of the approval procedure and for ensuring conformity of production, whether or not he is directly involved in all stages of the construction of a vehicle, system, component or separate technical unit. 6.The manufacturer shall establish procedures to ensure that series production of vehicles, systems, components and separate technical units remains in conformity with the approved type. 7.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 36, the manufacturer shall indicate his name, registered trade name or registered trade mark and his contact address in the Union on his 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. Article 12

Obligations of manufacturers concerning their vehicles, systems, components, separate technical units or parts and equipment that are not in conformity or that present a serious risk 1.A manufacturer who considers that a vehicle, system, component, separate technical unit, or part or equipment that has been placed on the market or entered into service is not in conformity with this Regulation or that the type approval has been granted on the basis incorrect data, shall immediately take the appropriate 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 has granted the 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 detailed information on the non-conformity and on any measures taken to the approval and market surveillance authorities of the Member States in which the vehicle, system, component, separate technical unit, part or equipment has been made available on the market or has entered into service to that effect. 3.The manufacturer shall keep the information package referred to in Article 24(4) for a period of ten years after the placing on the market of a vehicle and for a period of five years after the placing on the market for a system, component or separate technical unit. The vehicle manufacturer shall keep at the disposal of the approval authorities a copy of the certificates of conformity referred to in Article 34. 4.The manufacturer shall, upon a reasoned request from a national authority, provide that authority, through the approval authority, 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 or separate technical unit, in a language that can be easily understood by the national authority. The manufacturer 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 he has made available on the market. Article 13

Obligations of manufacturer’s representatives concerning market surveillance

1.The manufacturer’s representative for market surveillance shall perform the tasks specified in the mandate received from the manufacturer. That mandate shall provide for that representative to do at least the following: (a)have access to the information folder referred to in Article 22 and the certificate of conformity referred to in Article 34 in one of the official Union languages. Such documentation shall be made available to the approval authorities for a period of ten years after the placing on the market of a vehicle and for a period of five years after the placing on the market for a system, component or separate technical unit; (b)following a reasoned request from an approval authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of production of a vehicle, system, component or separate technical unit; (c)cooperate with the approval or market surveillance authorities, at their request, on any action taken to eliminate the serious risk posed by vehicles, systems, components, separate technical units, parts or equipment covered by that mandate; (d)immediately inform the manufacturer about complaints and reports relating to risks, suspected incidents, non-compliance issues with vehicles, systems, components, separate technical units, parts or equipment covered by that mandate; (e)terminate that mandate if the manufacturer acts contrary to his obligations under this Regulation. 2.A manufacturer's representative who terminates the mandate on the grounds referred to in point (e) of paragraph 1 shall immediately inform the type approval authority that granted the approval and the Commission. 3.The details of a change shall address at least the following aspects: (a)the date of termination of the mandate with the outgoing authorised representative and date of beginning of the mandate with the incoming manufacturer's representative; (b)the date until which the outgoing manufacturer's representative may be indicated in the information supplied by the manufacturer, including any promotional material; (c)the transfer of documents, including confidentiality aspects and property rights; (d)the obligation of the outgoing manufacturer's representative after the end of the mandate to forward to the manufacturer or incoming manufacturer's representative any complaints or reports about risks and suspected incidents related to a vehicle, system, component, separate technical unit, part or equipment for which he had been designated as manufacturer's representative. Article 14

Obligations of importers 1.The importer shall place on the market only vehicles, systems, components or separate technical units that have either received EU type-approval or national type-approval, or parts or equipment that comply with the requirements of Regulation (EC) No 765/2008. 2.Before placing on the market a type-approved vehicle, system, component or separate technical unit, the importer shall verify that an information package referred to in Article 24(4) has been put together by the approval authority, and that the system, component or separate technical unit bears the required type-approval mark and complies with Article 11(7). In the case of a vehicle, the importer shall ensure that the vehicle is accompanied by the required certificate of conformity. 3.Where the importer considers that a vehicle, system, component or separate technical unit is not in conformity with the requirements of this Regulation, and in particular that it does not correspond to its type-approval, he shall not place on the market, allow to enter into service or register the vehicle, system, component or separate technical unit, until it has been brought into conformity. Where he considers that the vehicle, system, component, separate technical unit, part or equipment presents a serious risk, he shall inform the manufacturer and the market surveillance authorities thereof. For type-approved vehicles, systems, components and separate technical units, he shall also inform the approval authority that has granted the type-approval. 4.The importer shall indicate his name, registered trade name or registered trade mark and his contact address on the vehicle, system, component, separate technical unit, part or equipment, or, where this is not possible, on its packaging or in a document accompanying the system, component, separate technical unit, part or equipment. 5.The importer shall ensure that the vehicle, system, component or separate technical unit is accompanied by the instructions and information required by Article 63 in the official language or languages of the Member States concerned. 6.The importer shall, to protect the health and safety of consumers, investigate and keep a register of complaints and recalls of vehicles, systems, components, separate technical units, parts or equipment that he has placed on the market and keep his distributors informed of such monitoring.

Article 15

Obligations of importers concerning their vehicles, systems, components or separate technical units that are not in conformity or concerning their vehicles, systems, components, separate technical units, parts or equipment that present a serious risk 1.Where a vehicle, system, component or separate technical unit that has been placed on the market by the importer is not in conformity with this Regulation, the importer shall immediately take the appropriate measures necessary to bring that vehicle, system, component or separate technical unit into conformity, to withdraw it from the market or to recall it, as appropriate. 2.Where a vehicle, system, component, separate technical unit, part or equipment presents a serious risk, the importer shall immediately provide detailed information on the serious risk to the manufacturer and the approval and market surveillance authorities of the Member States in which the vehicle, system, component, separate technical unit, part or equipment has been placed on the market. The importer shall also inform the approval and market surveillance authorities of any action taken and give details, in particular of the serious risk and of corrective measures taken by the manufacturer. 3.The importer shall, for a period of ten years after the placing on the market of the vehicle and for a period of five years as from the placing on the market for a system, component or separate technical unit, keep a copy of the certificate of conformity at the disposal of the approval and market surveillance authorities and ensure that the information package referred to in Article 24(4) can be made available to those authorities, upon request. 4.The importer shall, upon a reasoned request from a national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a vehicle, system, component or separate technical unit in a language that can be easily understood by that authority. The importer 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 he has made available on the market. Article 16

Obligations of distributors A distributor shall verify, before making available on the market, registering or entering into service of a vehicle, system, component or separate technical unit, that that vehicle, system, component or separate technical unit bears the required statutory plate or type-approval mark, that it is accompanied by the required documents and by instructions and safety information, required by Article 63, in the official language or languages of the relevant Member State, and that the manufacturer and the importer have complied with the requirements set out in Article 11(7) and Article 14(4) respectively. Article 17

Obligations of distributors concerning their vehicles, systems, components or separate technical units that are not in conformity or concerning their vehicles, systems, components, separate technical units, parts or equipment that present a serious risk 1.Where the distributor considers that a vehicle, system, component or separate technical unit is not in conformity with the requirements of this Regulation, he shall not make available on the market, register or enter into service the vehicle, system, component or separate technical unit until it has been brought into conformity. 2.The distributor who considers that a vehicle, system, component or separate technical unit that he has made available on the market is not in conformity with this Regulation, shall inform the manufacturer or the importer to ensure that the appropriate measures necessary to bring that vehicle, system, component or separate technical unit into conformity, to withdraw it from the market or to recall it, as appropriate, are taken in accordance with Article 12(1) or Article 15(1). 3.Where the vehicle, system, component, separate technical unit, part or equipment presents a serious risk, the distributor shall immediately provide detailed information on that serious risk to the manufacturer, the importer and the approval and market surveillance authorities of the Member States in which that vehicle, system, component, separate technical unit, part or equipment has been made available on the market. The distributor shall also inform them of any action taken and give details, in particular of the serious risk and of corrective measures taken by the manufacturer. 4.The distributor 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 he has made available on the market. Article 18

Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Articles 8, 11 and 12, where the importer or distributor makes available on the market, registers or is responsible for the entry into service of a vehicle, system, component or separate technical unit under its name or trademark or modifies a vehicle, system, component or separate technical unit in such a way that it may no longer comply with the applicable requirements. Article 19

Identification of economic operators Upon a request of an approval authority or a market surveillance authority, for a period of ten years after the placing on the market of a vehicle and for a period of five years after the placing on the market of a system, component, separate technical unit, part or equipment, economic operators shall provide information on the following: (a)the identity of any economic operator who has supplied them with a vehicle, system, component, separate technical unit, part or equipment; (b)the identity of any economic operator to whom they have supplied a vehicle, system, component, separate technical unit, part or equipment. CHAPTER III

PROCEDURES FOR EU TYPE-APPROVAL

Article 20

Procedures for EU type-approval 1.Where applying for a whole-vehicle type-approval, the manufacturer may choose one of the following procedures: (a)step-by-step type-approval; (b)single-step type-approval; (c)mixed type-approval. In addition, the manufacturer may choose multi-stage type-approval for an incomplete or completed vehicle. 2.For system type-approval, component type-approval and separate technical unit type-approval only the single-step type-approval is applicable. 3.Multi-stage type-approval shall be granted in respect of an incomplete or completed type of vehicle that, having regard to the state of completion of the vehicle, conforms to the particulars in the information folder provided for in Article 22 and meets the technical requirements laid down in the relevant regulatory acts listed in Annex IV. The multi-stage type-approval shall also apply to complete vehicles converted or modified by another manufacturer after their completion. 4.The EU type-approval for the final stage of completion shall be granted only after the approval authority has verified that the type of vehicle approved at the final stage meets at the time of the approval all applicable technical requirements. Verification shall include a documentary check of all requirements covered by an EU type-approval for an incomplete type of vehicle granted in the course of a multi-stage procedure, even where granted for a different category of vehicle. 5.The choice of type-approval referred to in paragraph 1 shall not affect the applicable substantive requirements with which the approved type of vehicle has to comply with at the time of issuing of the whole-vehicle type-approval. 6. Multi-stage type-approval may also be used by a single manufacturer, provided it is not used to circumvent the requirements applicable to vehicles built in a single stage. Vehicles built by a single manufacturer are not considered to be built in multiple stages for the purposes of Articles 39, 40 and 47 of this Regulation. Article 21

Application for EU type-approval 1.The manufacturer shall submit to the approval authority an application for EU type-approval and the information folder referred to in Article 22. 2.Only one application may be submitted in respect of a particular type of vehicle, system, component or separate technical unit and in one Member State only. 3.A separate application shall be submitted for each type of vehicle, system, component or separate technical unit to be approved. Article 22

Information folder 1.The information folder referred to in Article 21(1) shall include the following: (a)an information document, as set out in Annex I for single-step or mixed type-approval or in Annex III for step-by-step type-approval; (b)all data, drawings, photographs and other relevant information;

(c)for vehicles, an indication of the procedure(s) chosen in accordance with Article 20(1); (d)any additional information requested by the approval authority in the context of the application procedure. 2.The information folder shall be supplied in an electronic format to be provided by the Commission but may also be supplied on paper. 3.The Commission shall be empowered to adopt delegated acts in accordance with Article 88 to amend Annexes I and III to take account of technical and regulatory developments by updating the template for the information document, including a harmonised electronic format as referred to in paragraph 2. Article 23

Additional information to be provided with an application

for certain EU type-approvals 1.An application for a step-by-step type-approval shall, in addition to the information folder referred to in Article 22, be accompanied by the complete set of EU type-approval certificates, including the test reports, required pursuant to the applicable acts listed in Annex IV. In case of an application for a system type-approval, component type-approval or separate technical unit type-approval, pursuant to the applicable acts listed in Annex IV, the approval authority shall have access to the information folder until the whole-vehicle type-approval is either issued or refused. 2.An application for a mixed type-approval shall, in addition to the information folder referred to in Article 22, be accompanied by the EU type-approval certificates, including the test reports, required pursuant to the applicable acts listed in Annex IV. For systems for which no EU type-approval certificate has been presented, the application shall, in addition to the information folder referred to in Article 22, be accompanied by the information specified in Annex I, required for the approval of those systems during the vehicle approval phase, and by a test report instead of the EU type-approval certificate. 3.An application for a multi-stage type-approval shall be accompanied by the following information: (a)in the first stage, those parts of the information folder and the EU type-approval certificates that are relevant to the state of completion of the base vehicle; (b)in the second and subsequent stages, those parts of the information folder and the EU type-approval certificates that are relevant to the current stage of completion, together with a copy of the EU type-approval certificate for the vehicle issued at the preceding stage of construction and full details of any changes or additions that the manufacturer has made to the vehicle. The information specified in points (a) and (b) may be supplied in accordance with Article 22(2). 4. The approval authority and technical services shall have access to the software and algorithms of the vehicle. The approval authority may, by reasoned request, also require the manufacturer to supply any additional information needed to take a decision on which tests are required, or to facilitate the execution of those tests. CHAPTER IV

CONDUCT OF PROCEDURES FOR EU TYPE-APPROVAL Article 24

General provisions on conduct of procedures for EU