Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (Text with EEA relevance.)

Type Regulation
Publication 2018-06-14
Last updated 2026-08-02
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 94
Reform history JSON API

The Commission shall immediately communicate the decision referred to in the second subparagraph to the relevant economic operator or operators. Member States shall implement such acts without delay and shall inform the Commission accordingly.

Where the Commission considers that a notified national measure is unjustified, the Member State concerned shall withdraw or adapt the measure, in accordance with the Commission decision referred to in the second subparagraph.

6.

Where following tests and inspections carried out by the Commission in accordance with Article 9, the Commission establishes that a corrective or restrictive measure is necessary at Union level, it shall without delay consult the Member States concerned and the relevant economic operator or operators.

On the basis of consultation referred to in the first subparagraph of this paragraph, the Commission shall adopt implementing acts to decide on corrective or restrictive measures at Union level. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

The Commission shall immediately communicate the decision referred to in the second subparagraph to the relevant economic operator or operators. Member States shall implement such acts without delay and shall inform the Commission accordingly.

7.

Where the risk or non-compliance is attributed to shortcomings in regulatory acts listed in Annex II, the Commission shall propose appropriate measures as follows:

  • (a) where legal acts of the Union are concerned, the Commission shall propose the necessary amendments to the acts concerned;
  • (b) where UN Regulations are concerned, the Commission shall propose the necessary draft amendments to the relevant UN Regulations in accordance with the procedure applicable under the Revised 1958 Agreement.
8.

Where a corrective measure is considered to be justified in accordance with this Article or is subject to the implementing acts as referred to in paragraph 5 or 6, that measure shall be available free of charge to holders of registrations for the affected vehicles. Where repairs have been carried out at the registration holder's expense before the adoption of the corrective measure, the manufacturer shall reimburse the cost of such repairs up to the cost of the repairs required by that corrective measure.

Article 54

Non-compliant EU type-approval
1.

Where an approval authority finds that a type-approval that has been granted does not comply with this Regulation, it shall refuse to recognise that approval.

2.

The approval authority shall notify its refusal to the approval authority that granted the EU type-approval, to the approval authorities of the other Member States, and to the Commission. Where within one month after the notification, the non-compliance of the type-approval is confirmed by the approval authority that granted the EU type-approval, that approval authority shall withdraw the type-approval.

3.

Where, within one month after the notification referred to in paragraph 2, an objection has been raised by the approval authority that granted the EU type-approval, the Commission shall consult the Member States without delay, in particular the approval authority that granted the type-approval and the relevant economic operator.

4.

On the basis of the consultation referred to in paragraph 3 of this Article, the Commission shall adopt implementing acts to decide if the refusal of recognition of EU type-approval referred to in paragraph 1 of this Article is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

The Commission shall immediately communicate the decision referred to in the first subparagraph to the relevant economic operators. The Member States shall implement such acts without delay and shall inform the Commission accordingly.

5.

Where, following tests and inspections carried out by the Commission in accordance with Article 9, the Commission establishes that a type-approval that has been granted is not compliant with this Regulation, it shall consult the Member States without delay, in particular the approval authority that granted the type-approval and the relevant economic operator.

On the basis of consultations referred to in the first subparagraph of this paragraph the Commission shall adopt an implementing act to decide on the refusal of the recognition of type-approval referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

6.

Articles 51, 52 and 53 apply to vehicles, systems, components and separate technical units that are the subject of a non-compliant type-approval and that are already made available on the market.

Article 55

Placing on the market and entry into service of parts or equipment that may pose a serious risk to the correct functioning of essential systems
1.

Parts or equipment that may pose a serious risk to the correct functioning of systems that are essential for the safety of the vehicle or for its environmental performance shall not be placed on the market, shall not enter into service, and shall be prohibited, unless they have been authorised by an approval authority in accordance with Article 56.

2.

Such authorisations shall only apply to the limited number of parts or equipment, that are included in the list referred to in paragraph 4.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 82, supplementing this Regulation by laying down the requirements for the authorisation of the parts and equipment referred to in paragraph 1 of this Article.

Those requirements may be based on the regulatory acts listed in Annex II or may consist of a comparison of the environmental or safety performance of the parts or equipment with the environmental or safety performance of the original parts or equipment, as appropriate. In either case, the requirements shall ensure that the parts or equipment do not impair the functioning of the systems that are essential for the safety of the vehicle or for its environmental performance.

4.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex VI to take account of technical and regulatory developments by laying down and updating the list of parts or equipment on the basis of an evaluation of the following:

  • (a) the extent to which there exists a serious risk to the safety or environmental performance of vehicles that are fitted with the parts or equipment in question;
  • (b) the potential effect on consumers and aftermarket manufacturers of a possible authorisation of the parts or equipment under Article 56(1).
5.

Paragraph 1 shall not apply to original parts or equipment or to parts or equipment belonging to a system that has been type-approved in accordance with the regulatory acts listed in Annex II, except where the type-approval relates to aspects other than the serious risk referred to in paragraph 1.

For the purposes of this Article, original parts or equipment means parts or equipment that are manufactured according to the specifications and production standards provided by the vehicle manufacturer for the assembly of the vehicle in question.

6.

Paragraph 1 of this Article shall not apply to parts or equipment that are exclusively produced for racing vehicles. Parts or equipment listed in Annex VI that are used both in racing and on the road shall only be made available on the market for vehicles intended for use on public roads, if they comply with the requirements laid down in the delegated acts referred to in paragraph 3 of this Article and have been authorised by the Commission. The Commission shall adopt implementing acts to decide whether to grant those authorisations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

Article 56

1.

A manufacturer of parts or equipment may apply for the authorisation referred to in Article 55(1) by submitting to the approval authority an application accompanied by a test report that is drafted by a technical service and that certifies that the parts or equipment for which authorisation is sought comply with the requirements referred to in Article 55(3). Such manufacturer may submit only one application for each type of part or equipment and to one approval authority only.

2.

The application for the authorisation shall include details of the manufacturer of the parts or equipment, the type, the identification and part numbers of the parts or equipment, the vehicle manufacturer's name, the type of vehicle and, where appropriate, the year of construction and any other information permitting the identification of the vehicle to which the parts or equipment are to be fitted.

The approval authority shall authorise the placing on the market and the entering into service of the parts or equipment where it finds, taking into account the test report referred to in paragraph 1 of this Article and other evidence, that the parts or equipment in question comply with the requirements referred to in Article 55(3).

The approval authority shall issue to the manufacturer an authorisation certificate without delay.

The Commission shall adopt implementing acts laying down the template and the numbering system for the authorisation certificate referred to in the third subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

3.

The manufacturer shall inform without delay the approval authority that issued the authorisation of any change affecting the conditions under which the authorisation has been issued. That approval authority shall decide whether the authorisation has to be reviewed or reissued and whether further tests are necessary.

The manufacturer shall ensure that the parts or equipment are produced and continue to be produced under the conditions under which the authorisation has been issued.

4.

Before issuing any authorisation, the approval authority shall verify the existence of arrangements and procedures for ensuring effective control of the conformity of production.

Where the approval authority finds that the conditions for issuing the authorisation are no longer fulfilled, it shall request the manufacturer to take the necessary measures to ensure that the parts or equipment are brought into conformity. Where necessary, it shall withdraw the authorisation.

5.

Upon request of a national authority of another Member State, the approval authority that has issued the authorisation shall, within one month of the receipt of that request, send to the former a copy of the issued authorisation certificate together with its attachments by means of a common secure electronic exchange system. The copy may also take the form of a secure electronic file.

6.

An approval authority that disagrees with the authorisation issued by another Member State shall bring the reasons for its disagreement to the attention of the Commission. The Commission shall take the appropriate measures in order to resolve the disagreement. Inter alia, the Commission may, where necessary and after having consulted the relevant approval authorities, adopt implementing acts requiring the withdrawal of the authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

7.

Until the list referred to in Article 55(4) has been established, Member States may maintain national provisions regarding parts or equipment that may affect the correct functioning of systems essential for the safety of the vehicle or its environmental performance.

CHAPTER XII INTERNATIONAL REGULATIONS

Article 57

UN Regulations required for EU type-approval
1.

UN Regulations or amendments thereto which the Union has voted in favour of, or that the Union applies and that are listed in Annex II, shall be part of the requirements for the EU type-approval of vehicles, systems, components or separate technical units.

2.

Where the Union has voted in favour of a UN Regulation or amendments thereto for the purpose of whole-vehicle type-approval, the Commission shall adopt delegated acts in accordance with Article 82, supplementing this Regulation by making that UN Regulation or the amendments thereto compulsory or amending this Regulation.

Those delegated acts shall specify the dates from which that UN Regulation or amendments are to be compulsory, and shall include transitional provisions, where appropriate, and, where applicable for the purposes of EU type-approval, first registration and entry into service of vehicles and making available on the market of systems, components and separate technical units.

Article 58

Equivalence of UN Regulations for the purpose of EU type-approval
1.

The UN Regulations listed in Part II of Annex II are recognised as being equivalent to the corresponding regulatory acts to the extent that they share the same scope and subject matter.

2.

The approval authorities of the Member States shall accept type-approvals granted in accordance with the UN Regulations referred to in paragraph 1 and, where applicable, shall accept the relevant approval marks in place of the corresponding type-approvals and approval marks that were granted in accordance with this Regulation and the regulatory acts listed in Annex II.

CHAPTER XIII PROVISION OF TECHNICAL INFORMATION

Article 59

Information intended for users
1.

The manufacturer shall not supply any technical information related to the particulars of the type of vehicle, system, component, separate technical unit, part or equipment provided for in this Regulation or in the regulatory acts listed in Annex II, that diverges from the particulars of the type-approval granted by the approval authority.

2.

The manufacturer shall make available to users all relevant information and necessary instructions that describe any special conditions or restrictions on the use of a vehicle, system, component, separate technical unit, part or equipment.

3.

The information referred to in paragraph 2 shall be supplied in the official language or languages of the Member State where the vehicle, system, component, separate technical unit, part or equipment is to be placed on the market, registered or is to be entered into service. It shall also be provided in the owner's manual.

Article 60

Information intended for manufacturers
1.

Manufacturers of vehicles shall make available to the manufacturers of systems, components, separate technical units, parts or equipment all particulars that are necessary for EU type-approval of systems, components or separate technical units or to obtain the authorisation referred to in Article 55(1).

Manufacturers of vehicles may impose a binding agreement on the manufacturers of systems, components, separate technical units, parts or equipment to protect the confidentiality of any information that is not in the public domain, including information related to intellectual property rights.

2.

Manufacturers of systems, components, separate technical units, parts or equipment shall provide the manufacturers of vehicles with all detailed information on the restrictions that apply to their type-approvals and that are either referred to in Article 29(3) or imposed by a regulatory act listed in Annex II.

CHAPTER XIV ACCESS TO VEHICLE OBD INFORMATION AND VEHICLE REPAIR AND MAINTENANCE INFORMATION

Article 61

Manufacturers' obligations to provide vehicle OBD information and vehicle repair and maintenance information
1.

Manufacturers shall provide to independent operators unrestricted, standardised and non-discriminatory access to vehicle OBD information, diagnostic and other equipment, tools including the complete references, and available downloads, of the applicable software and vehicle repair and maintenance information. Information shall be presented in an easily accessible manner in the form of machine-readable and electronically processable datasets. Independent operators shall have access to the remote diagnosis services used by manufacturers and authorised dealers and repairers.

Manufacturers shall provide a standardised, secure and remote facility to enable independent repairers to complete operations that involve access to the vehicle security system.

2.

Until the Commission has adopted a relevant standard through the work of the European Committee for Standardisation (CEN) or a comparable standardisation body, the vehicle OBD information and vehicle repair and maintenance information shall be presented in an easily accessible manner that can be processed with reasonable effort by independent operators.

The vehicle OBD information and the vehicle repair and maintenance information shall be made available on the websites of manufacturers using a standardised format or, if this is not feasible, due to the nature of the information, in another appropriate format. For independent operators other than repairers, the information shall also be given in a machine-readable format that is capable of being electronically processed with commonly available information technology tools and software and which allows independent operators to carry out the task associated with their business in the aftermarket supply chain.

3.

However, in the following cases, it shall be sufficient that the manufacturer provides the required information promptly in an easily accessible manner when an independent operator so requests:

  • (a) for vehicle types covered by a national type-approval of vehicles produced in small series as referred to in Article 42;
  • (b) for special purpose vehicles;
  • (c) for vehicle types of categories O1 and O2 that do not use diagnostic tools or a physical or wireless communication with the on-board electronic control unit or units for the purpose of diagnostics or reprogramming of their vehicles;
  • (d) for the final stage of type-approval in a multi-stage type-approval procedure, where the final stage only covers bodywork which does not contain electronic vehicle control systems, and all electronic vehicle control systems of the base vehicle remain unchanged.
4.

The details of the technical requirements for access to vehicle OBD information and vehicle repair and maintenance information, in particular technical specifications on how vehicle OBD information and vehicle repair and maintenance information are to be provided, are laid down in Annex X.

5.

Manufacturers shall also make training material available to independent operators and authorised dealers and repairers.

6.

Manufacturers shall ensure that the vehicle OBD information and the vehicle repair and maintenance information are always accessible, except as required for maintenance purposes of the information system.

Manufacturers shall make any subsequent amendments and supplements to vehicle OBD information and vehicle repair and maintenance information available on their websites at the same time they are made available to authorised repairers.

7.

For the purposes of manufacturing and servicing of OBD-compatible replacement or service parts and diagnostic tools and test equipment, manufacturers shall provide the relevant vehicle OBD information and vehicle repair and maintenance information on a non-discriminatory basis to any interested manufacturer or repairer of components, diagnostic tools or test equipment.

8.

For the purposes of the design, manufacturing and the repair of automotive equipment for alternative-fuel vehicles, manufacturers shall provide the relevant vehicle OBD information and vehicle repair and maintenance information on a non-discriminatory basis to any interested manufacturer, installer or repairer of equipment for alternative-fuel vehicles.

9.

Where repair and maintenance records of a vehicle are kept in a central database of the vehicle manufacturer or on its behalf, independent repairers shall have access to such records free of charge and shall be able to enter information on repair and maintenance which they have performed.

10.

This Chapter shall not apply to vehicles that are covered by individual vehicle approvals.

11.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex X to take account of technical and regulatory developments or prevent misuse by updating the requirements concerning the access to vehicle OBD information and vehicle repair and maintenance information, including the repair and maintenance activities supported by wireless wide area networks and by adopting and integrating the standards referred to in paragraph 2 of this Article. The Commission shall take into account current information technology, foreseeable vehicle technology developments, existing ISO standards and the possibility of a worldwide ISO standard.

Article 62

Obligations with regard to holders of several type-approvals
1.

The manufacturer responsible for the respective type-approval of a system, component or separate technical unit or for a particular stage of a vehicle shall be responsible, in the event of a mixed type-approval, a step-by-step type-approval or a multi-stage type-approval, for communicating to both the final manufacturer and the independent operators the repair and maintenance information relating to the particular system, component or separate technical unit or to the particular stage.

2.

In the case of multi-stage type-approval, the final manufacturer shall be responsible for providing access to vehicle OBD information and vehicle repair and maintenance information regarding its own manufacturing stage or stages and the link to the previous stage or stages.

Article 63

Fees for access to vehicle repair and maintenance information
1.

The manufacturer may charge reasonable and proportionate fees for access to vehicle repair and maintenance information other than the records referred to in Article 61(10). Those fees shall not discourage access to such information by failing to take into account the extent to which the independent operator uses it. Access to vehicle repair and maintenance information shall be offered free of charge to national authorities, the Commission and technical services.

2.

The manufacturer shall make available vehicle repair and maintenance information, including transactional services such as reprogramming or technical assistance, on an hourly, daily, monthly, and yearly basis, with fees for access to such information varying in accordance with the respective periods of time for which access is granted.

In addition to time-based access, manufacturers may offer transaction-based access for which fees are charged per transaction and not based on the duration for which access is granted.

Where the manufacturer offers both systems of access, independent repairers shall choose systems of access, which may be either time-based or transaction-based.

Article 64

Proof of compliance with vehicle OBD information and repair and maintenance information obligations
1.

The manufacturer that has applied for EU type-approval or national type-approval shall provide the approval authority with proof of compliance with this Chapter within six months from the date of the respective type-approval.

2.

Where such proof of compliance is not provided within the period referred to in paragraph 1 of this Article, the approval authority shall take appropriate measures in accordance with Article 65.

Article 65

Compliance with the obligations regarding access to vehicle OBD information and vehicle repair and maintenance information
1.

An approval authority may at any time, whether on its own initiative, on the basis of a complaint, or on the basis of an assessment by a technical service, check that a manufacturer is in compliance with this Chapter and with the Manufacturer's certificate on access to vehicle OBD information and vehicle repair and maintenance information referred to in Appendix 1 to Annex X.

2.

Where an approval authority finds that the manufacturer has failed to comply with its obligations regarding access to vehicle OBD information and vehicle repair and maintenance information, the approval authority that granted the relevant type-approval shall take appropriate measures to remedy the situation.

Those measures may include the withdrawal or suspension of the type-approval, fines or other measures adopted pursuant to Article 84.

3.

Where an independent operator or a trade association representing independent operators files a complaint to the approval authority on the failure of the manufacturer to comply with this Chapter, the approval authority shall carry out an audit in order to verify compliance by the manufacturer. The approval authority shall request the approval authority that granted the whole vehicle type-approval to investigate the complaint and subsequently to ask for evidence from the vehicle manufacturer demonstrating that the system that the vehicle manufacturer has in place is in compliance with this Regulation. The results of that investigation shall be communicated to the national approval authority and the independent operator or trade association concerned within three months of the request.

4.

When carrying out the audit, the approval authority may ask a technical service or any other independent expert to carry out an assessment to verify whether the obligations concerning access to vehicle OBD information and vehicle repair and maintenance information have been met.

Article 66

Forum on Access to Vehicle Information
1.

The Forum on Access to Vehicle Information regarding access to vehicle OBD information and vehicle repair and maintenance information, established in accordance with Article 13(9) of Commission Regulation (EC) No 692/2008 ([^E0008]), shall also cover all vehicles within the scope of this Regulation.

It shall carry out its activities in accordance with Annex X to this Regulation.

2.

The Forum on Access to Vehicle Information shall consider whether access to vehicle OBD information and vehicle repair and maintenance information affects the advances made in reducing vehicle theft, and shall make recommendations for improving the requirements relating to access to such information. In particular, the Forum on Access to Vehicle Information shall advise the Commission on the introduction of a process by which accredited organisations approve and authorise independent operators to access information on vehicle security.

The Commission may decide to keep the discussions and findings of the Forum on Access to Vehicle Information confidential.

CHAPTER XV ASSESSMENT, DESIGNATION, NOTIFICATION AND MONITORING OF TECHNICAL SERVICES

Article 67

Type-approval authority responsible for technical services
1.

The approval authority designated by the Member State in accordance with Article 6(2), (referred to for the purposes of this Chapter as the ‘type-approval authority’), shall be responsible for the assessment, designation, notification and monitoring of technical services, including, where appropriate, the subcontractors or subsidiaries of those technical services. The type-approval authority may decide that the assessment and monitoring of technical services and, where appropriate, of the subcontractors or subsidiaries of those technical services, is to be carried out by a national accreditation body.

2.

Type-approval authorities shall be subject to peer evaluations in respect of any activity which they carry out related to the assessment and monitoring of technical services.

Peer evaluations shall cover the assessments of the entire or partial operations of technical services that have been carried out by type-approval authorities in accordance with Article 73(4), including the competence of the personnel, the correctness of the test and inspection methodology and the correctness of test results based on a defined scope of regulatory acts listed in Part I of Annex II.

Activities related to the assessment and monitoring of technical services that only deal with national individual approvals that were granted in accordance with Article 45 or with national type-approvals of vehicles produced in small series that were granted in accordance with Article 42 are exempted from peer evaluations

Any assessment of accredited technical services by type-approval authorities shall be exempt from peer evaluations.

3.

Type-approval authorities shall not be subject to peer evaluations when they designate all their technical services exclusively on the basis of accreditation of the technical services.

4.

The type-approval authority shall not provide consultancy services on a commercial or competitive basis.

5.

The type-approval authority shall have a sufficient personnel at its disposal to carry out the tasks laid down in this Regulation.

6.

Each Member State shall provide the Commission, the Forum and other Member States that so request with information on its procedures for the assessment, designation and notification of technical services and for the monitoring of technical services, and of any changes to the procedures.

The Commission may adopt implementing acts laying down the model for the provision of information on the procedures of the Member States referred to in the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

7.

Type-approval authorities that are subject to peer-evaluations shall establish procedures for internal audits in accordance with Appendix 2 of Annex III. Such internal audits shall be performed at least once a year. However, the frequency of internal audits may be reduced if the type-approval authority can demonstrate that its management system is being implemented effectively and has proven stability.

8.

Peer-evaluations of a type-approval authority shall be carried out at least once every five years by a peer-evaluation team, composed of two type-approval authorities from other Member States.

The Commission may decide to participate in the peer-evaluation team on the basis of a risk assessment analysis.

The peer-evaluation shall be carried out under the responsibility of the approval authority that is subject to evaluation, and shall include a visit to the premises of a technical service selected at the discretion of the peer-evaluation team.

Type-approval authorities that are not subject to peer-evaluation in accordance with paragraph 3 shall not be included in any of the activities related to the peer-evaluation team.

9.

Taking duly into account the considerations of the Forum, the Commission may adopt implementing acts setting out a plan for peer-evaluations covering a period of at least five years, laying down criteria concerning the composition of the peer-evaluation team, the methodology used for the peer-evaluation, the schedule, periodicity and the other tasks related to the peer-evaluation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

10.

The outcome of the peer evaluations shall be examined by the Forum. The Commission shall draw up summaries of the outcome of peer evaluations and make them public.

Article 68

Designation of technical services
1.

The type-approval authorities shall designate technical services for one or more of the following categories of activities, depending on their field of competence:

  • (a) category A: tests referred to in this Regulation and in the regulatory acts listed in Annex II that technical services carry out in their own facilities;
  • (b) category B: the supervision of the tests, which includes test preparation, referred to in this Regulation and in the regulatory acts listed in Annex II, where such tests are performed at the manufacturer's facilities or at the facilities of a third party;
  • (c) category C: the assessment and monitoring on a regular basis of the procedures of the manufacturer for controlling the conformity of production;
  • (d) category D: the supervision or performance of tests or inspections for the surveillance of the conformity of production.
2.

Each Member State may designate a type-approval authority as a technical service for one or more of the categories of activities referred to in paragraph 1.

3.

A technical service shall be established under the law of a Member State and have legal personality, except for a technical service belonging to a type-approval authority and except for an accredited in-house technical service of the manufacturer, as referred to in Article 72.

4.

A technical service shall take out liability insurance for its activities, unless such liability is assumed by its Member State in accordance with national law, or unless the Member State itself is directly responsible for the conformity assessment.

5.

Technical services of a third country, other than those that have been designated in accordance with Article 72, may only be designated and may only be notified to the Commission for the purposes of Article 74 where a bilateral agreement between the Union and the third country concerned provides for the possibility of designating such technical services. This shall not prevent a technical service that is established under the law of a Member State in accordance with paragraph 3 of this Article from establishing subsidiaries in third countries, provided that those subsidiaries are directly managed and controlled by the designated technical service.

Article 69

Independence of the technical services
1.

A technical service, including its personnel, shall be independent and shall carry out the activities for which it has been designated with the highest degree of professional integrity and the requisite technical competence in the specific field in which it operates and shall be free from all pressures and inducements, particularly financial, that might influence its judgment or the results of its assessment activities, in particular such pressures or inducements emanating from persons or groups of persons with an interest in the results of those activities.

2.

Technical services shall be third-party organisation or body that is not involved in the process of the design, manufacturing, supply or maintenance of the vehicle, system, component or separate technical unit that it assesses, tests or inspects.

An organisation or body that belongs to a trade association or to a professional federation representing undertakings that are involved in the design, manufacturing, supply or maintenance of the vehicles, systems, components or separate technical units that it assesses, tests or inspects, may be considered as fulfilling the requirements of the first subparagraph, provided that its independence and the absence of any conflict of interest are demonstrated to the type-approval authority of the relevant Member State.

3.

A technical service, its top-level management and the personnel responsible for carrying out the activities for which they are designated in accordance with Article 68(1) shall not design, manufacture, supply, or maintain the vehicles, systems, components or separate technical units that they assess, nor represent parties engaged in those activities. This shall not preclude the use of those vehicles, systems, components or separate technical units that are necessary for the operation of the technical service or the use of such vehicles, systems, components or separate technical units for personal purposes.

4.

A technical service shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of the categories of activities for which it has been designated.

5.

The personnel of a technical service shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the type-approval authority and, where relevant, to the national accreditation body, or where required by Union or national law.

Article 70

Competence of the technical services
1.

A technical service shall be capable of carrying out all the activities for which it is applying to be designated in accordance with Article 68(1). It shall demonstrate to the type-approval authority or to the national accreditation body carrying out the assessment or monitoring of that technical service that it satisfies all of the following conditions:

  • (a) its personnel have the appropriate skills, the specific technical knowledge, the vocational training and sufficient and appropriate experience to perform the activities for which it is applying to be designated;
  • (b) it possesses descriptions of the procedures relevant for the performance of the activities for which it is applying to be designated, taking due account of the degree of complexity of the technology of the relevant vehicle, system, component or separate technical unit in question, as well as the mass or serial nature of the production process. The technical service shall demonstrate the transparency and reproducibility of those procedures;
  • (c) it has the necessary means to perform the tasks connected with the category or categories of activities for which it is applying to be designated, and it has access to all necessary equipment or facilities.
2.

A technical service shall also demonstrate that it has the appropriate skills, the specific technical knowledge and proven experience to carry out tests and inspections for assessing the conformity of the vehicles, systems, components and separate technical units with this Regulation and shall demonstrate its compliance with the standards listed in Appendix 1 to Annex III. However, the standards listed in Appendix 1 to Annex III do not apply for the purposes of the last stage of a national multi-stage procedure referred to in Article 47(1).

3.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex III as regards the requirements for the assessment of the technical services.

Article 71

Subsidiaries of and subcontracting by technical services
1.

Technical services may subcontract, with the agreement of the designating type-approval authority, some of the categories of activities for which they have been designated in accordance with Article 68(1), or have those activities carried out by a subsidiary.

2.

Where a technical service subcontracts specific tasks within the categories of activities for which it has been designated or has a subsidiary perform those tasks, it shall ensure that the subcontractor or the subsidiary complies with the requirements set out in Articles 68, 69 and 70 and shall inform the type-approval authority thereof.

3.

Technical services shall take full responsibility for the tasks performed by their subcontractors or subsidiaries, regardless of their place of establishment.

4.

Technical services shall keep at the disposal of the designating type-approval authority the relevant documents concerning the assessment carried out by the type-approval authority or the accreditation carried out by the national accreditation body of the subcontractor or the subsidiary and the tasks performed by them.

Article 72

In-house technical service of the manufacturer
1.

An in-house technical service of a manufacturer may be designated as a technical service for activities under category A as referred to in point (a) of Article 68(1), and only with regard to the regulatory acts listed in Annex VII. An in-house technical service shall constitute a separate and distinct part of the manufacturer's company and shall not be involved in the design, manufacturing, supply or maintenance of the vehicles, systems, components or separate technical units that it assesses.

2.

An in-house technical service referred to in paragraph 1 shall comply with the following requirements:

  • (a) it has been accredited by a national accreditation body and complies with the requirements laid down in Appendices 1 and 2 to Annex III;
  • (b) the in-house technical service, including its personnel, is organisationally identifiable and has reporting methods within the manufacturer's company of which they form part that ensures its impartiality and demonstrates that impartiality to the relevant type-approval authority and to the national accreditation body;
  • (c) neither the in-house technical service nor its personnel is engaged in any activity that might conflict with its independence or with its integrity to perform the activities for which it has been designated;
  • (d) it supplies its services only to the manufacturer's company of which it forms part.
3.

The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex VII to take account of technical and regulatory developments by updating the list of regulatory acts and restrictions contained therein.

Article 73

Assessment and designation of technical services
1.

The applicant technical service shall submit a formal application to the type-approval authority of the Member State in which it requests to be designated in accordance with point 4 of Appendix 2 to Annex III. The application shall specify the categories of the activities for which the technical service is applying to be designated.

2.

Before a type-approval authority designates a technical service, the type-approval authority or the national accreditation body shall assess it in accordance with an assessment check-list that covers at least the requirements laid down in Appendix 2 to Annex III. The assessment shall include an on-site assessment in the premises of the applicant technical service, and, where relevant, of any subsidiary or sub-contractor, whether located inside or outside the Union.

3.

In cases where the assessment is carried out by a national accreditation body, the applicant technical service shall deliver to the type-approval authority a valid accreditation certificate and the corresponding assessment report attesting that the technical service fulfils the requirements laid down in Appendix 2 to Annex III for the categories of activities for which the applicant technical service is applying to be designated.

4.

In cases where the assessment is carried out by the type-approval authority, the type-approval authority of the Member State from which the applicant technical service has requested to be designated shall formally appoint a joint assessment team composed of representatives of the type-approval authorities of at least two other Member States and a representative of the Commission.

Where the technical service applies to be designated in a Member State other than the Member State of its establishment, one of the representatives of the joint assessment team shall be from the type-approval authority of the Member State of its establishment, unless that type-approval authority decides against participating in the joint assessment team.

The joint assessment team shall participate in the assessment of the applicant technical service, including the on-site assessment. The designating type-approval authority of the Member State in which the applicant technical service has requested to be designated shall give the joint assessment team all necessary assistance and provide timely access to all documentation necessary to assess the applicant technical service.

5.

In cases where the assessment is carried out by the type-approval authority that designates technical services which apply to perform tests exclusively for national individual vehicle approvals in accordance with Article 45, the type-approval authority of the Member State in which the applicant technical service has requested to be designated shall be exempt from the obligation to appoint a joint assessment team. The technical services which are only checking the correct installation of components on categories O1 and O2 shall also be exempt from assessment.

6.

If the technical service has requested to be designated by one or more type-approval authorities from Member States other than the Member State of its establishment in accordance with Article 74(2), the assessment shall be carried out only once, provided that the entire scope of the technical service's designation has been covered in that assessment.

7.

The joint assessment team shall raise findings regarding non-compliance of the applicant technical service with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III during the assessment process. Such findings shall be discussed within the joint assessment team.

8.

The joint assessment team shall produce after the on-site assessment a report setting out the extent to which the applicant technical service complies with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

9.

The report referred to in paragraph 8 shall contain a summary of any identified non-compliances, together with a recommendation as to whether the applicant may be designated as technical service.

10.

The type-approval authority shall notify to the Commission the names and the expertise of their representatives who are to participate in each joint assessment team.

11.

The type-approval authority of the Member State where the applicant technical service has requested to be designated shall send the report on the outcome of the assessment in accordance with the procedures laid down in Appendix 2 to Annex III, to the Commission and, upon request, to the type-approval authorities of the other Member States. That report shall include documentary evidence regarding the competence of the technical service and the arrangements that the type-approval authority has in place to regularly monitor the technical service.

12.

The type-approval authorities of the other Member States and the Commission may review the assessment report and the documentary evidence, raise questions or concerns and request further documentary evidence within one month from the date of reception of the assessment report and the documentary evidence.

13.

The type-approval authority of the Member State where the applicant technical service has requested to be designated shall respond to the questions, concerns and requests for further documentary evidence within four weeks following their receipt.

14.

Within four weeks following the receipt of the response referred to in paragraph 13, the type-approval authorities of the other Member States or the Commission may individually or jointly address recommendations to the type-approval authority of the Member State where the applicant technical service has requested to be designated. That type-approval authority shall take account of the recommendations when it takes the decision on the designation of the technical service. Where that type-approval authority decides not to follow the recommendations addressed by the other Member States or the Commission, it shall give the reasons therefor within two weeks after taking its decision.

15.

The validity of the designation of technical services shall be limited to five years.

16.

The type-approval authority that intends to be designated as a technical service in accordance with Article 68(2) shall document compliance with this Regulation through an assessment conducted by independent auditors. Those auditors may be from within the same organisation provided that they are managed autonomously from the personnel undertaking the assessed activity, and provided that they comply with the requirements laid down in Appendix 2 to Annex III.

Article 74

Notification to the Commission concerning designation of technical services
1.

The type-approval authorities shall notify to the Commission the name, the address, including the electronic address, the responsible persons and the category of activities of every technical service that they have designated. The notification shall clearly specify the scope of the designation, the conformity assessment activities and procedures, the type of vehicles, systems, components and separate technical units, and the subjects listed in Annex II, for which the technical services have been designated, as well as any subcontractors or subsidiaries of the technical services, and any subsequent modifications to any of those details.

Such notification shall be made before the designated technical service concerned conducts any activity referred to in Article 68(1).

2.

A technical service may be designated by one or more type-approval authorities of Member States other than the Member State of its establishment, provided that the entire scope of the designation by the type-approval authority is covered by an accreditation issued in accordance with Article 73(3), or by an assessment carried out in accordance with Article 73(4).

3.

The Commission shall publish on its website, and keep up-to-date, a list with contact details of the designated technical services, their subcontractors and their subsidiaries that have been notified to it in accordance with this Article.

Article 75

Changes to and renewal of designations of technical services
1.

Where the type-approval authority has ascertained or has been informed that a technical service no longer complies with the requirements laid down in this Regulation, that type-approval authority shall restrict, suspend or withdraw the designation, as appropriate, depending on the seriousness of the failure to comply with those requirements.

The type-approval authority shall immediately notify to the Commission and the type-approval authorities of the other Member States any restriction, suspension or withdrawal of a designation.

The Commission shall update the list referred to in Article 74(3) accordingly.

2.

In the event of a restriction, suspension or withdrawal of the designation, or where the technical service has ceased its activity, the type-approval authority shall keep the files of that technical service available for the approval authorities or for the market surveillance authorities or transfer those files to another technical service chosen by the manufacturer in agreement with that technical service.

3.

The type-approval authority shall assess within three months of the notification referred to in the second subparagraph of paragraph 1 whether the non-compliance of the technical service has an impact on EU type-approval certificates issued on the basis of the inspection and test reports issued by the technical service subject of the change in designation and inform the other type-approval authorities and the Commission accordingly.

Within two months after having notified the changes to the designation, the type-approval authority shall submit a report on its findings regarding the non-compliance to the Commission and the other type-approval authorities. Where necessary to ensure the safety of vehicles, systems, components or separate technical units already placed on the market, the designating type-approval authority shall instruct the type-approval authorities concerned to suspend or withdraw within a reasonable period of time, any EU type-approval certificates which were unduly issued.

4.

Where the designation of technical services has been restricted, suspended or withdrawn, the EU type-approval certificates which were issued on the basis of inspection and test reports issued by those technical services shall remain valid unless those type-approvals become invalid in accordance with point (f) of Article 35(2).

5.

Extensions of the scope of the technical service's designation that lead to the designation of an additional category of activities referred to in Article 68(1) shall be assessed in accordance with the procedure set out in Article 73.

Extensions of the scope of a technical service's designation only for the regulatory acts listed in Annex II may be carried out in accordance with the procedures laid down in Appendix 2 to Annex III, and subject to the notification referred to in Article 74.

6.

The designation of a technical service shall only be renewed after the type-approval authority has verified that the technical service continues to comply with the requirements of this Regulation. That assessment shall be carried out in accordance with the procedure set out in Article 73.

Article 76

Monitoring of technical services
1.

The designating type-approval authority shall continuously monitor the technical services to ensure compliance with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

The first subparagraph of this paragraph shall not apply to any activities of technical services which are monitored by accreditation bodies in accordance with Article 67(1) for the purposes of ensuring compliance with the requirements laid down in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III.

Technical services shall supply on request all relevant information and documents that are required to enable the designating type-approval authority or national accreditation body to verify compliance with those requirements.

Technical services shall inform the designating type-approval authority or national accreditation body without delay of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III, or their ability to perform the conformity assessment tasks relating to the vehicles, systems, components and separate technical units for which they have been designated.

2.

Technical services shall respond without delay to requests by a type-approval authority or by the Commission in relation to the conformity assessments they have carried out.

3.

The designating type-approval authority shall ensure that the technical service carries out its obligation laid down in paragraph 2 of this Article, unless there is a legitimate reason for not doing so.

Where that type-approval authority acknowledges a legitimate reason, it shall inform the Commission thereof.

The Commission shall consult the Member States without delay. On the basis of that consultation, the Commission shall adopt implementing acts to decide if the legitimate reason is justified or not. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

The technical service and the designating type-approval authority may request that any information that is transmitted to the type-approval authority of another Member State or to the Commission shall be treated confidentially.

4.

At least every 30 months, the designating type-approval authority shall assess whether each technical service under its responsibility continues to satisfy the requirements set out in Articles 68 to 72, in Articles 80 and 81 and in Appendix 2 to Annex III. That assessment shall include an on-site assessment of each technical service under its responsibility.

Within two months after finalising the assessment of the technical service, each Member State shall report to the Commission and to the other Member States on its monitoring activities. Those reports shall contain a summary of the assessment, which shall be made publicly available.

Article 77

Challenge to the competence of technical services
1.

The Commission, in cooperation with the type-approval authority of the Member State concerned, shall investigate all cases where concerns have been brought to its attention regarding the competence of a technical service or the continued compliance by a technical service with the requirements and responsibilities to which it is subject under this Regulation. The Commission may also commence such investigations on its own initiative.

The Commission shall investigate the responsibility of the technical service in the case where it is demonstrated or where there are justified grounds for considering that a type-approval has been granted on the basis of false data, that the test results have been falsified or that data or technical specifications have been withheld that would have led to the refusal to grant the type-approval.

2.

The Commission shall consult the designating type-approval authority, as part of the investigation referred to in paragraph 1. That type-approval authority shall provide the Commission, upon request, with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned.

3.

The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4.

Where the Commission ascertains that a technical service does not comply or no longer complies with the requirements for its designation, or that it is responsible for any of the situations referred to in paragraph 1, it shall inform the Member State of the designating type-approval authority thereof.

The Commission shall request that Member State to take restrictive measures, including the restriction, suspension or withdrawal of the designation, where necessary.

Where a Member State fails to take the necessary restrictive measures, the Commission may adopt implementing acts to decide to restrict, suspend or withdraw the designation of the technical service concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The Commission shall notify the Member State concerned of those implementing acts and shall update the information published referred to in Article 74(3) accordingly.

Article 78

Exchange of information on assessment, designation and monitoring of technical services
1.

Type-approval authorities shall consult each other and the Commission on questions with general relevance with regard to the implementation of the requirements set out in this Regulation in relation with the assessment, designation and monitoring of technical services.

2.

Type-approval authorities shall communicate to each other and the Commission the model for the assessment check-list used in accordance with Article 73(2) by 5 July 2020 and, thereafter, the adaptations made to that check-list, until the Commission has adopted a harmonised assessment check-list. The Commission is empowered to adopt implementing acts to establish the template of the harmonised assessment check-list. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2).

3.

Where the assessment reports referred to in Article 73(8) indicate discrepancies in the general practice of type-approval authorities, Member States or the Commission may request an exchange of information.

The exchange of information shall be coordinated by the Forum.

Article 79

Cooperation with national accreditation bodies
1.

Where the designation of a technical service is based on accreditation within the meaning of Regulation (EC) No 765/2008, the national accreditation body and the type-approval authority shall fully cooperate and shall exchange relevant information in compliance with Regulation (EC) No 765/2008, including incident reports and other information that relate to matters under the control of the technical service when that information is relevant for the assessment of the performance of the technical service.

2.

Member States shall ensure that type-approval authority of the Member State in which the technical service is established keeps the national accreditation body in charge of the accreditation of a particular technical service informed of any findings that are relevant to the accreditation. The national accreditation body shall inform the type-approval authority of the Member State in which the technical service is established of its findings.

Article 80

Operational obligations of technical services
1.

Technical services shall carry out the activities for which they have been designated in accordance with Article 68(1).

2.

At all times, technical services shall:

  • (a) allow the designating type-approval authority to witness the performance of the technical service during testing for type-approval; and
  • (b) where requested, provide the designating type-approval authority with information on the categories of activities for which they have been designated.
3.

Where a technical service finds that a manufacturer does not comply with the requirements laid down in this Regulation, it shall report this non-compliance to the type-approval authority in order for that type-approval authority to require the manufacturer to take appropriate corrective measures. The type-approval authority shall refuse to issue a type-approval certificate where those appropriate corrective measures have not been taken.

Article 81

Information obligations of technical services
1.

Technical services shall inform the designating type-approval authority of the following:

  • (a) any non-conformity encountered which may require the refusal, restriction, suspension or withdrawal of a type-approval certificate;
  • (b) any circumstances affecting the scope of and conditions for their designation;
  • (c) any request for information which they have received from market surveillance authorities regarding their activities.
2.

Upon request from the designating type-approval authority, technical services shall provide information on the activities within the scope of their designation or on any other activity they have performed, including cross-border activities and subcontracting.

CHAPTER XVI DELEGATED AND IMPLEMENTING POWERS

Article 82

Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.

The power to adopt delegated acts referred to in Article 4(2), Article 5(3), Article 26(3), Article 30(8), Article 31(8), Article 41(5), Article 44(7), Article 55(3) and (4), Article 57(2), Article 61(11), Article 70(3), Article 72(3) and Article 85(2) shall be conferred on the Commission for a period of five years from 4 July 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.

The delegation of power referred to in Article 4(2), Article 5(3), Article 26(3), Article 30(8), Article 31(8), Article 41(5), Article 44(7), Article 55(3) and (4), Article 57(2), Article 61(11), Article 70(3), Article 72(3) and Article 85(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.

A delegated act adopted pursuant to Article 4(2), Article 5(3), Article 26(3), Article 30(8), Article 31(8), Article 41(5), Article 44(7), Article 55(3) and (4), Article 57(2), Article 61(11), Article 70(3), Article 72(3) and Article 85(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 83

Committee procedure
1.

The Commission shall be assisted by the Technical Committee — Motor Vehicles (TCMV). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

CHAPTER XVII FINAL PROVISIONS

Article 84

Penalties
1.

Member States shall lay down the rules on penalties applicable to infringements by economic operators, independent operators, and technical services of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. In particular, those penalties shall be proportionate to the seriousness of the non-compliance and to the number of non-compliant vehicles, systems, components or separate technical units made available on the market of the Member State concerned. Member States shall notify the Commission of those rules and of those measures and shall notify it without delay of any subsequent amendment affecting them.

2.

The types of infringements by economic operators and technical services subject to penalties shall be at least the following:

  • (a) making false declarations during approval procedures or corrective or restrictive measures being imposed in accordance with Chapter XI;
  • (b) falsifying test results for type-approval or for market surveillance;
  • (c) withholding data or technical specifications that could lead to the recall of vehicles, systems, components and separate technical units, or to the refusal or withdrawal of EU type-approval certificate;
  • (d) non-compliance by technical services in respect of the requirements for their designation.
3.

In addition to the types of infringements set out in paragraph 2, the types of infringements by economic operators that are also subject to penalties shall be at least the following:

  • (a) refusal to provide access to information;
  • (b) making available on the market vehicles, systems, components or separate technical units subject to approval without such approval, or falsifying documents, certificates of conformity, statutory plates or approval marks with that intention;
  • (c) tampering with the vehicle and its systems.

3a. In additional to the types of infringements set out in paragraphs 2 and 3, the types of infringements by manufacturers that are also subject to penalties shall be at least the following:

  • (a) falsifying test results for in-service conformity under emission type-approval;
  • (b) designing, constructing and assembling vehicles with manipulation devices or manipulation strategies, which cause a non-compliant vehicle to appear compliant with this Regulation;
  • (c) designing, constructing and assembling vehicles of categories M1, M2, M3, N1, N2 and N3 without the required excess exhaust emissions driver warning systems or low-reagent driver warning systems.

3b. The types of infringements by independent operators subject to penalties shall include at least tampering with the vehicle and its systems.

4.

Member States shall report to the Commission every year on the penalties they have imposed in the preceding year. If no penalties were imposed in a given year, Member States shall not be required to report to the Commission.

5.

Each year, the Commission shall elaborate a summary report on the penalties imposed by Member States. That report may include recommendations for Members States and shall be submitted to the Forum.

Article 85

Administrative fines in support of corrective and restrictive measures at Union level
1.

When the Commission takes decisions in accordance with Article 53, it may impose administrative fines upon the concerned economic operators for non-compliance of the vehicle, system, component or separate technical unit with the requirements laid down in this Regulation. The administrative fines provided for shall be effective, proportionate and dissuasive. In particular the fines shall be proportionate to the number of non-compliant vehicles registered in the Union market, or the number of non-compliant systems, components or separate technical unit made available on the Union market.

The administrative fines imposed by the Commission shall not be in addition to the penalties imposed by the Member States in accordance with Article 84 for the same infringement. The administrative fines imposed by the Commission shall not exceed EUR 30 000 per non-compliant vehicle, system, component or separate technical unit.

The Commission may not bring, start afresh or continue proceedings under this Article against economic operators for infringements of this Regulation for which the concerned economic operators have been penalised or declared not liable in accordance with Article 84 by an earlier decision that can no longer be challenged.

2.

The Commission shall adopt, on the basis of the principles set out in paragraph 3 of this Article, delegated acts in accordance with Article 82, supplementing this Regulation by laying down the procedure for, and methods for the calculation and collection of, the administrative fines referred to in paragraph 1 of this Article.

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