EN Official Journal of the European Union L 263/1

DIRECTIVE 2007/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 September 2007

establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles

(Framework Directive)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

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

Acting in accordance with the procedure referred to in Article 251 of the Treaty (2),

Whereas:

(1) Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3), has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity.

(2) For the purposes of the establishment and operation of the internal market of the Community, it is appropriate to replace the Member States’ approval systems with a Community approval procedure based on the principle of total harmonisation.

(3) The technical requirements applicable to systems, components, separate technical units and vehicles should be harmonised and specified in regulatory acts. Those regulatory acts should primarily seek to ensure a high level of road safety, health protection, environmental protection, energy efficiency and protection against unauthorised use.

(4) Council Directive 92/53/EEC of 18 June 1992 amending Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4) limited application of the Community whole vehicle type-approval procedure to the vehicle category M1. However, in order to complete the internal market and to ensure that it functions properly, the scope of the present Directive should cover all categories of vehicles, enabling manufacturers to benefit from the advantages of the internal market by means of the Community type-approval.

(5) In order to enable manufacturers to adapt to the new harmonised procedures, a sufficient lead-time should be allowed before Community vehicle type-approval becomes compulsory for vehicles belonging to categories other than M1 that are built in one stage. A longer lead-time is required for vehicles of categories other than M1 that require a multi-stage approval, since that procedure will involve body-builders, who will need to gain sufficient experience in that field so that the necessary procedures can be implemented properly. However, due to the importance of safety for vehicles of category M2 and M3, during the transitional period when national type approval is still valid in order to allow manufacturers to get experience with EC vehicle type approval, it is necessary that those vehicles comply with the technical requirements of the harmonised directives.

(6) Until now, manufacturers who produce vehicles in small series have been partially excluded from the benefits of the internal market. Experience has shown that road safety and protection of the environment could be significantly improved if small series vehicles were totally integrated into the Community vehicle type-approval system, starting with category M1.

(7) In order to prevent abuse, any simplified procedure for small series vehicles should be restricted to cases of very limited production; it is therefore necessary to define more precisely the concept of small series in terms of the number of vehicles produced.

(8) It is important to lay down measures enabling vehicles to be approved on an individual basis, in order to allow sufficient flexibility in the multi-stage approval system; however, pending the establishment of harmonised, specific Community provisions, Member States should continue to be allowed to grant individual approvals in accordance with their national rules.

(9) Pending application of the Community vehicle type-approval procedures to categories of vehicles other than M1, Member States should be allowed to continue to grant vehicle type-approvals on a national basis, and transitional provisions should be laid down accordingly.

(10) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

(11) By Council Decision 97/836/EC (6), the Community acceded to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (Revised 1958 Agreement). Consequently, United Nations Economic Commission for Europe (UNECE) Regulations to which the Community accedes, in application of that Decision, and amendments to UNECE Regulations to which the Community has already acceded should be incorporated within the Community type-approval procedure either as requirements for EC vehicle type-approval, or as alternatives to existing Community law. In particular, where the Community decides, by means of a Council decision, that a UNECE Regulation shall become part of the EC vehicle type-approval procedure and replace existing Community law, the Commission should be empowered to make the necessary adaptations to this Directive. Since those measures are of general scope and are designed to amend non-essential elements of this Directive or to supplement it by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(12) For the purposes of better regulation and simplification and in order to avoid having to constantly update existing Community legislation on issues of technical specifications, it should be possible for this Directive or for separate directives and regulations to make references to existing international standards and regulations without reproducing them in the Community legal framework.

(13) In order to ensure that the procedure for monitoring conformity of production, which is one of the cornerstones of the Community type-approval system, has been correctly implemented and functions properly, manufacturers should be regularly checked by the competent authority or by an appropriately qualified technical service appointed for that purpose.

(14) The main objective of the legislation on the approval of vehicles is to ensure that new vehicles, components and separate technical units put on the market provide a high level of safety and environmental protection. This aim should not be impaired by the fitting of certain parts or equipment after vehicles have been placed on the market or have entered service. Thus, appropriate measures should be taken in order to make sure that parts or equipment which can be fitted to vehicles and which are capable of significantly impairing the functioning of systems that are essential in terms of safety or environmental protection, are subject to a prior control by an approval authority before they are offered for sale. These measures should consist of technical provisions concerning the requirements that those parts or equipment have to comply with.

(15) These measures should only apply to a limited number of parts or equipment. The list of such parts or equipment and subsequent requirements should be established after having consulted stakeholders. In establishing the list, the Commission should consult stakeholders on the basis of a report and strive for a fair balance between the requirements of improving road safety and environmental protection, as well as the interests of consumers, manufacturers and distributors in preserving competition in the aftermarket.

(16) The list of parts and equipment, the essential systems concerned as well as the testing and implementation measures should be determined in accordance with Decision 1999/468/EC. Since those measures are of general scope and are designed to amend non-essential elements of this Directive or to supplement it by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of that Decision.

(17) This Directive constitutes a set of specific safety requirements within the meaning of Article 1(2) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (7), laying down specific requirements for protecting the health and safety of consumers. Therefore, it is important to establish provisions to ensure that, in case a vehicle presents a serious risk for consumers resulting from the application of this Directive or of the regulatory acts listed in Annex IV, the manufacturer has taken effective protective measures, including the recall of vehicles. Approval authorities should therefore be able to assess whether the proposed measures are sufficient or not.

(18) It is important that manufacturers supply relevant information to vehicle owners in order to prevent misuse of safety devices. It is appropriate to include provisions thereon in this Directive.

(19) It is also important for equipment manufacturers to have access to certain information that is available only from the vehicle manufacturer, that is to say, the technical information, including drawings, required for the development of parts for the aftermarket.

(20) It is equally important that manufacturers make information readily available to independent operators to ensure the repairing and maintenance of vehicles in a fully competitive market. These information requirements have so far been incorporated in Community legislation, and in particular in Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and 6) and on access to vehicle repair and maintenance information (8), on the basis that the Commission will present a report, no later than four years after the date of entry into force of that Regulation, on the operation of the system of access to vehicle repair and maintenance information and will consider whether it would be appropriate to consolidate all provisions governing access to such information within a revised framework directive on type approval.

(21) With the aim of simplifying and accelerating the procedure, measures implementing the separate directives or regulations as well as measures for adapting the annexes to this Directive and the separate directives or regulations, in particular to the development of scientific and technical knowledge, should be adopted in accordance with Decision 1999/468/EC. Since those measures are of general scope and are designed to amend non-essential elements of this Directive or of the separate directives or regulations, or to supplement them by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of that Decision. The same procedure should apply to adaptations needed for the type-approval of vehicles intended for persons with disabilities.

(22) Experience shows that appropriate measures may have to be taken without delay with a view to ensuring a better protection of road users where shortcomings have been identified in the existing legislation. For such urgent cases, the necessary amendments to the separate directives or regulations should be adopted in accordance with Decision 1999/468/EC. Since those measures are of general scope and are designed to amend non-essential elements of the separate directives or regulations or to supplement them by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of that Decision.

(23) Since the objective of this Directive, namely the achievement of the internal market through the introduction of a compulsory system of Community type-approval for all categories of vehicles, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective.

(24) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the earlier Directives. The obligation to transpose the provisions which are unchanged arises under the earlier Directives.

(25) In accordance with point 34 of the Interinstitutional Agreement on better law-making (9), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(26) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the directives set out in Part B of Annex XX.

(27) The requirements of this Directive are in accordance with the principles enshrined in the Action plan entitled ‘Simplifying and improving the regulatory environment’.

(28) It is of particular importance that future measures proposed on the basis of this Directive or procedures to be implemented in application of it should comply with these principles, which have been restated by the Commission in its communication on a Competitive Automotive Regulatory framework for the 21st Century,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Directive establishes a harmonised framework containing the administrative provisions and general technical requirements for approval of all new vehicles within its scope and of the systems, components and separate technical units intended for those vehicles, with a view to facilitating their registration, sale and entry into service within the Community.

This Directive also establishes the provisions for the sale and entry into service of parts and equipment intended for vehicles approved in accordance with this Directive.

Specific technical requirements concerning the construction and functioning of vehicles shall be laid down in application of this Directive in regulatory acts, the exhaustive list of which is set out in Annex IV.

Article 2

Scope

1. This Directive applies to the type-approval of vehicles designed and constructed in one or more stages for use on the road, and of systems, components and separate technical units designed and constructed for such vehicles.

It also applies to the individual approval of such vehicles.

This Directive also applies to parts and equipment intended for vehicles covered by this Directive.

2. This Directive does not apply to the type-approval or individual approval of the following vehicles:

(a) agricultural or forestry tractors, as defined in Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (10) and trailers designed and constructed specifically to be towed by them;

(b) quadricycles as defined in Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (11);

(c) tracked vehicles.

3. Type-approval or individual approval under this Directive is optional for the following vehicles:

(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; and

(c) mobile machinery,

to the extent that these vehicles fulfil the requirements of this Directive. Such optional approvals shall be without prejudice to the application of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (12).

4. An individual approval under this Directive is optional for the following vehicles:

(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 this purpose.

Article 3

Definitions

For the purposes of this Directive and of the regulatory acts listed in Annex IV, save as otherwise provided therein:

1. ‘regulatory act’ means a separate directive or regulation or a UNECE Regulation annexed to the Revised 1958 Agreement;

2. ‘separate directive or regulation’ means a directive or regulation listed in Part I of Annex IV. This term includes also their implementing acts;

3. ‘type-approval’ means the procedure whereby a Member State certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

4. ‘national type-approval’ means a type-approval procedure laid down by the national law of a Member State, the validity of such approval being restricted to the territory of that Member State;

5. ‘EC type-approval’ means the procedure whereby a Member State certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements of this Directive and of the regulatory acts listed in Annex IV or XI;

6. ‘individual approval’ means the procedure whereby a Member State certifies that a particular vehicle, whether unique or not, satisfies the relevant administrative provisions and technical requirements;

7. ‘multi-stage type-approval’ means the procedure whereby one or more Member States certify that, depending on the state of completion, an incomplete or completed type of vehicle satisfies the relevant administrative provisions and technical requirements of this Directive;

8. ‘step-by-step type-approval’ means a vehicle approval procedure consisting in the step-by-step collection of the whole set of EC type-approval certificates for the systems, components and separate technical units relating to the vehicle, and which leads, at the final stage, to the approval of the whole vehicle;

9. ‘single-step type-approval’ means a procedure consisting in the approval of a vehicle as a whole by means of a single operation;

10. ‘mixed type-approval’ means a step-by-step type-approval procedure for which one or more system approvals are achieved during the final stage of the approval of the whole vehicle, without it being necessary to issue the EC type-approval certificates for those systems;

11. ‘motor vehicle’ means any power-driven vehicle which is moved by its own means, having at least four wheels, being complete, completed or incomplete, with a maximum design speed exceeding 25 km/h;

12. ‘trailer’ means any non-self-propelled vehicle on wheels which is designed and constructed to be towed by a motor vehicle;

13. ‘vehicle’ means any motor vehicle or its trailer as defined in points (11) and (12);

14. ‘hybrid motor vehicle’ means a vehicle with at least two different energy converters and two different energy storage systems (on-vehicle) for the purpose of vehicle propulsion;

15. ‘hybrid electric vehicle’ means a hybrid vehicle that, for the purpose of mechanical propulsion, draws energy from both of the following on-vehicle sources of stored energy/power: — a consumable fuel, — an electrical energy/power storage device (e.g. battery, capacitor, flywheel/generator, etc.);

16. ‘mobile machinery’ means any self-propelled vehicle which is designed and constructed specifically to perform work which, because of its construction characteristics, is not suitable for carrying passengers or for transporting goods. Machinery mounted on a motor vehicle chassis shall not be considered as mobile machinery;

17. ‘type of vehicle’ means vehicles of a particular category which do not differ in at least the essential respects specified in Section B of Annex II. A type of vehicle may contain variants and versions as defined in Section B of Annex II;

18. ‘base vehicle’ means any vehicle which is used at the initial stage of a multi-stage type-approval process;

19. ‘incomplete vehicle’ means any vehicle which must undergo at least one further stage of completion in order to meet the relevant technical requirements of this Directive;

20. ‘completed vehicle’ means a vehicle, resulting from the process of multi-stage type-approval, which meets the relevant technical requirements of this Directive;

21. ‘complete vehicle’ means any vehicle which need not be completed in order to meet the relevant technical requirements of this Directive;

22. ‘end-of-series vehicle’ means any vehicle that is part of a stock which cannot be registered or sold or entered into service owing to the entry into force of new technical requirements against which it has not been approved;

23. ‘system’ means an assembly of devices combined to perform one or more specific functions in a vehicle and which is subject to the requirements of any of the regulatory acts;

24. ‘component’ means a device subject to the requirements of a regulatory act and intended to be part of a vehicle, which may be type-approved independently of a vehicle where the regulatory act makes express provisions for so doing;

25. ‘separate technical unit’ means a device subject to the requirements of a regulatory act and intended to be part of a vehicle, which may be type-approved separately, but only in relation to one or more specified types of vehicle where the regulatory act makes express provisions for so doing;

26. ‘original parts or equipment’ means parts or equipment which are manufactured according to the specifications and production standards provided by the vehicle manufacturer for the production of parts or equipment for the assembly of the vehicle in question. This includes parts or equipment which are manufactured on the same production line as these parts or equipment. It is presumed unless the contrary is proven, that parts constitute original parts if the part manufacturer certifies that the parts match the quality of the components used for the assembly of the vehicle in question and have been manufactured according to the specifications and production standards of the vehicle manufacturer;

27. ‘manufacturer’ means the person or body who is responsible to the approval authority for all aspects of the type-approval or authorisation process and for ensuring conformity of production. It is not essential that the person or body be directly involved in all stages of the construction of the vehicle, system, component or separate technical unit which is the subject of the approval process;

28. ‘manufacturer’s representative’ means any natural or legal person established in the Community who is duly appointed by the manufacturer to represent him before the approval authority and to act on his behalf in matters covered by this Directive, and where reference is made to the term ‘manufacturer’, it is to be understood as indicating either the manufacturer or his representative;

29. ‘approval authority’ means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

30. ‘competent authority’ in Article 42 means either the approval authority or a designated authority, or an accreditation body acting on their behalf;

31. ‘technical service’ means an organisation or body designated by the approval authority of a Member State 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, on behalf of the approval authority, it being possible for the approval authority itself to carry out those functions;

32. ‘virtual testing method’ means computer simulations including calculations which demonstrate whether a vehicle, a system, a component or a separate technical unit fulfils the technical requirements of a regulatory act. For testing purposes, a virtual method does not require the use of a physical vehicle, system, component or separate technical unit;

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

34. ‘EC type-approval certificate’ means the certificate set out in Annex VI or in the corresponding annex to a separate directive or regulation, the communication form set out in the relevant Annex to one of the UNECE Regulations listed in Part I or Part II of Annex IV to this Directive, being deemed to be equivalent thereto;

35. ‘individual approval certificate’ means the document whereby the approval authority officially certifies that a particular vehicle is approved;

36. ‘certificate of conformity’ means the document set out in Annex IX, issued by the manufacturer and certifying that a vehicle belonging to the series of the type approved in accordance with this Directive complied with all regulatory acts at the time of its production;

37. ‘information document’ means the document set out in Annex I or Annex III, or in the corresponding Annex to a separate directive, or regulation, that prescribes the information to be supplied by an applicant, it being permissible to supply the information document in the form of an electronic file;

38. ‘information folder’ means the complete folder, including the information document, file, data, drawings, photographs, and so on, supplied by the applicant, it being permissible to supply the information folder in the form of an electronic file;

39. ‘information package’ means the information folder accompanied by the test reports and all other documents added by the technical service or by the approval authority to the information folder in the course of carrying out their functions, it being permissible to supply the information package in the form of an electronic file;

40. ‘index to the information package’ means the document listing the contents of the information package, suitably numbered or otherwise marked so as to identify clearly all the pages, the format of that document being such as to present a record of the successive steps in the management of the EC type-approval, in particular the dates of the revisions and updating.

CHAPTER II

GENERAL OBLIGATIONS

Article 4

Obligations of Member States

1. Member States shall ensure that manufacturers applying for approval comply with their obligations under this Directive.

2. Member States shall approve only such vehicles, systems, components or separate technical units as satisfy the requirements of this Directive.

3. Member States shall register or permit the sale or entry into service only of such vehicles, components and separate technical units as satisfy the requirements of this Directive.

They shall not prohibit, restrict or impede the registration, sale, entry into service or circulation on the road of vehicles, components or separate technical units, on grounds related to aspects of their construction and functioning covered by this Directive, if they satisfy the requirements of the latter.

4. Member States shall establish or appoint the authorities competent in matters concerning approval, and notify to the Commission such establishment or appointment in accordance with Article 43.

The notification act of the approval authorities shall include the name, the address, including electronic address, and their area of responsibility.

Article 5

Obligations of manufacturers

1. The manufacturer is responsible to the approval authority for all aspects of the approval process and for ensuring conformity of production, whether or not the manufacturer is directly involved in all stages of the construction of a vehicle, system, component or separate technical unit.

2. In the case of multi-stage type-approval, each manufacturer is responsible for the approval and conformity of production of the systems, components or separate technical units added at the stage of vehicle completion handled by him.

The manufacturer who modifies components or systems already approved at earlier stages shall be responsible for the approval and conformity of production of those components and systems.

3. For the purposes of this Directive, a manufacturer established outside the Community shall appoint a representative established in the Community to represent him before the approval authority.

CHAPTER III

EC TYPE-APPROVAL PROCEDURES

Article 6

Procedures to be followed for the EC type-approval of vehicles

1. The manufacturer may choose one of the following procedures:

(a) step-by-step type-approval;

(b) single-step type-approval;

(c) mixed type-approval.

2. An application for step-by-step type-approval shall consist of the information folder containing the information required under Annex III and shall be accompanied by the complete set of type-approval certificates required pursuant to each of the applicable regulatory acts listed in Annex IV or Annex XI. In the case of the type-approval of a system or separate technical unit, pursuant to the applicable regulatory acts, the approval authority shall have access to the related information package until such time as the approval is either issued or refused.

3. An application for single-step type-approval shall consist of the information folder containing the relevant information required under Annex I, in relation to the regulatory acts specified in Annex IV or Annex XI and, where applicable, in Part II of Annex III.

4. In the case of a mixed type-approval procedure, the approval authority may exempt a manufacturer from the obligation to produce one or more EC system type-approval certificates, provided that the information folder is supplemented by the particulars, specified in Annex I, required for the approval of those systems during the vehicle approval phase, in which case each of the EC type-approval certificates thus waived shall be replaced by a test report.

5. Without prejudice to paragraphs 2, 3 and 4, the following information shall be supplied for the purposes of multi-stage type-approval:

(a) at the first stage, those parts of the information folder and the EC type-approval certificates required for a complete vehicle which are relevant to the state of completion of the base vehicle;

(b) at the second and subsequent stages, those parts of the information folder and the EC type-approval certificates which are relevant to the current stage of construction, together with a copy of the EC type-approval certificate for the vehicle issued at the preceding stage of construction; in addition, the manufacturer shall supply full details of any changes or additions that he has made to the vehicle. The information specified in points (a) and (b) may be supplied in accordance with the mixed type-approval procedure set out in paragraph 4.

6. The manufacturer shall submit the application to the approval authority. Only one application may be submitted in respect of a particular type of vehicle and it may be submitted in only one Member State.

A separate application shall be submitted for each type to be approved.

7. The approval authority may, by reasoned request, call upon the manufacturer to supply any additional information needed to enable a decision to be taken on what tests are required or to facilitate the execution of those tests.

8. The manufacturer shall make available to the approval authority as many vehicles as are necessary to enable the type-approval procedure to be conducted satisfactorily.

Article 7

Procedure to be followed for the EC type-approval of systems, components or separate technical units

1. The manufacturer shall submit the application to the approval authority. Only one application may be submitted in respect of a particular type of system, component or separate technical unit and it may be submitted in only one Member State. A separate application shall be submitted for each type to be approved.

2. The application shall be accompanied by the information folder, the content of which is specified in the separate directives or regulations.

3. The approval authority may, by reasoned request, call upon the manufacturer to supply any additional information needed to enable a decision to be taken on what tests are required or to facilitate the execution of those tests.

4. The manufacturer shall make available to the approval authority as many vehicles, components or separate technical units as are required under the relevant separate directives or regulations for the performance of the required tests.

CHAPTER IV

CONDUCT OF EC TYPE-APPROVAL PROCEDURES

Article 8

General provisions

1. Member States may not grant any EC type-approval without first ensuring that the procedures referred to in Article 12 have been duly and satisfactorily implemented.

2. Member States shall grant EC type-approvals in accordance with Articles 9 and 10.

3. If a Member State finds that a type of vehicle, system, component or separate technical unit, albeit in conformity with the required provisions, presents a serious risk to road safety or seriously harms the environment or seriously harms public health, it may refuse to grant EC type-approval. In this case, it shall immediately send the other Member States and the Commission a detailed file explaining the reasons for its decision and setting out the evidence for its findings.

4. EC type-approval certificates shall be numbered in accordance with the method set out in Annex VII.

5. The approval authority shall, within 20 working days, send to the approval authorities of the other Member States a copy of the EC vehicle type-approval certificate, together with the attachments, for each type of vehicle which it has approved. The hard copy may be replaced by an electronic file.

6. The approval authority shall inform without delay the approval authorities of the other Member States of its refusal or withdrawal of any vehicle approval, together with the reasons for its decision.

7. The approval authority shall send at three-monthly intervals to the approval authorities of the other Member States a list of the system, component or separate technical unit EC type-approvals it has granted, amended, refused to grant or withdrawn during the preceding period. That list shall contain the particulars specified in Annex XIV.

8. If so requested by another Member State, the Member State which has granted an EC type-approval shall, within 20 working days of receiving that request, send a copy of the EC type-approval certificate in question, together with the attachments. The hard copy may be replaced by an electronic file.

Article 9

Specific provisions concerning vehicles

1. Member States shall grant an EC approval in respect of:

(a) a type of vehicle which conforms to the particulars in the information folder and which meets the technical requirements specified by the relevant regulatory acts listed in Annex IV;

(b) a type of special-purpose vehicle which conforms to the particulars in the information folder and which meets the technical requirements specified by the relevant regulatory acts listed in Annex XI.

The procedures set out in Annex V shall apply.

2. Member States shall grant a multi-stage type-approval in respect of a type of incomplete or completed vehicle which conforms to the particulars in the information folder and which meets the technical requirements specified by the relevant regulatory acts listed in Annex IV or Annex XI, having regard to the state of completion of the vehicle.

The multi-stage type-approval shall apply also to complete vehicles converted or modified by another manufacturer.

The procedures set out in Annex XVII shall apply.

3. In respect of each type of vehicle, the approval authority shall:

(a) complete all the relevant sections of the EC type-approval certificate, including the test results sheet appended thereto, in accordance with the model set out in Annex VIII;

(b) compile or verify the index to the information package;

(c) issue the completed certificate, together with its attachments, to the applicant without unjustified delay.

4. In the case of an EC type-approval in relation to which, in accordance with Articles 20 or 22 or Annex XI, restrictions have been imposed as to its validity, or certain provisions of the regulatory acts have been waived, the EC type-approval certificate shall specify those restrictions or waivers.

5. Where particulars in the information folder specify provisions for special purpose vehicles as indicated in Annex XI, the EC type-approval certificate shall specify those provisions.

6. Where the manufacturer chooses the mixed type-approval procedure, the approval authority shall complete, in Part III of the information document, the model for which is set out in Annex III, the references for the test reports, established by regulatory acts, for which no EC type-approval certificate is available.

7. Where the manufacturer chooses the single-step type-approval procedure, the approval authority shall establish the list of applicable regulatory acts, the template of which is shown in the Appendix to Annex VI, and append that list to the EC type-approval certificate.

Article 10

Specific provisions concerning systems, components or separate technical units

1. Member States shall grant an EC type-approval in respect of a system which conforms to the particulars in the information folder and which meets the technical requirements laid down in the relevant separate directive or regulation, as prescribed in Annex IV or Annex XI.

2. Member States shall grant a component or separate technical unit EC type-approval in respect of a component or separate technical unit which conforms to the particulars in the information folder and which meets the technical requirements laid down in the relevant separate directive or regulation, as prescribed in Annex IV.

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

4. Where a component or separate technical unit fulfils its function or offers a specific feature only in conjunction with other parts of the vehicle, thereby making it possible to verify compliance with the requirements only when the component or separate technical unit is operating in conjunction with those other vehicle parts, the scope of the EC type-approval of the component or the separate technical unit shall be restricted accordingly. In such cases, the EC type-approval certificate shall specify any restriction on its use and shall indicate the special conditions for its mounting. When such a component or separate technical unit is fitted by the vehicle manufacturer, compliance with any applicable restrictions on use or conditions for mounting shall be verified at the time when the vehicle is approved.

Article 11

Tests required for EC type-approval

1. Compliance with the technical prescriptions laid down in this Directive and in the regulatory acts listed in Annex IV shall be demonstrated by means of appropriate tests performed by designated technical services.

The test procedures, the specific equipment and tools necessary to perform those tests shall be described in each of the regulatory acts.

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

However, the manufacturer may select, in agreement with the approval authority, a vehicle, a system, a component or a separate technical unit which, while not representative of the type to be approved, combines a number of the most unfavourable features with regard to the required level of performance. Virtual testing methods may be used to aid decision-making during the selection process.

3. As alternatives to the test procedures referred to in paragraph 1 and with the agreement of the approval authority, virtual testing methods may be used at the request of the manufacturer with respect to the regulatory acts listed in Annex XVI.

4. The general conditions which virtual testing methods must fulfil are set out in Appendix 1 to Annex XVI.

For each of the regulatory acts listed in Annex XVI, the specific testing conditions and the administrative provisions related thereto shall be laid down in Appendix 2 to that Annex.

5. The Commission shall establish the list of the regulatory acts for which virtual testing methods are permitted, the specific conditions and the administrative provisions related thereto. These measures, designed to amend non-essential elements of this Directive, inter alia by supplementing it, shall be established and updated in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).

Article 12

Conformity of production arrangements

1. The Member State which grants an EC type-approval shall take the necessary measures in accordance with Annex X to verify, if need be in cooperation with the approval authorities of the other Member States, that adequate arrangements have been made to ensure that production vehicles, systems, components or separate technical units, as the case may be, conform to the approved type.

2. The Member State which has granted an EC type-approval shall take the necessary measures in accordance with Annex X in relation to that approval to verify, if need be in cooperation with the approval authorities of the other Member States, that the arrangements referred to in paragraph 1 continue to be adequate and that production vehicles, systems, components or separate technical units, as the case may be, continue to conform to the approved type.

Verification to ensure that products conform to the approved type shall be limited to the procedures set out in Annex X and in those regulatory acts that contain specific requirements. To that end, the approval authority of the Member State which has granted the EC type-approval may carry out any of the checks or tests prescribed in any of the regulatory acts listed in Annex IV or Annex XI on samples taken in the premises of the manufacturer, including production facilities.

3. When a Member State which has granted an EC type-approval establishes that the arrangements referred to in paragraph 1 are not being applied, deviate significantly from the arrangements and control plans agreed, or have ceased to be applied, although production is not discontinued, that Member State shall take the necessary measures, including the withdrawal of the type-approval, to ensure that the conformity of production procedure is followed correctly.

CHAPTER V

AMENDMENTS TO EC TYPE-APPROVALS

Article 13

General provisions

1. The manufacturer shall inform without delay the Member State that granted the EC type-approval of any change in the particulars recorded in the information package. That Member State shall decide, in accordance with the rules laid down in this Chapter, which procedure is to be followed. Where necessary, the Member State may decide, in consultation with the manufacturer, that a new EC type-approval is to be granted.

2. An application for the amendment of an EC type-approval shall be submitted exclusively to the Member State that granted the original EC type-approval.

3. If the Member State finds that, for the purposes of making an amendment, fresh inspections or fresh tests are necessary, it shall inform the manufacturer accordingly. The procedures referred to in Articles 14 and 15 shall apply only after the requisite fresh inspections or fresh tests have been successfully carried out.

Article 14

Specific provisions concerning vehicles

1. If particulars recorded in the information package have changed, the amendment shall be designated a ‘revision’.

In such cases, the approval authority shall issue the revised page of the information package as necessary, marking each revised pages to show clearly the nature of the change and the date of re-issue. A consolidated, updated version of the information package, accompanied by a detailed description of the changes, shall be deemed to meet this requirement.

2. The revision shall be designated an ‘extension’ if, in addition to the provisions of paragraph 1:

(a) further inspections or fresh tests are required;

(b) any information on the EC type-approval certificate, with the exception of its attachments, has changed;

(c) new requirements under any of the regulatory acts applicable to the approved vehicle type enter into force.

In such cases, the approval authority shall issue a revised EC type-approval certificate denoted by an extension number, incremented in accordance with the number of successive extensions already granted.

The approval certificate shall show clearly the reason for the extension and the date of re-issue.

3. Whenever amended pages or a consolidated, updated version are issued, the index to the information package attached to the approval certificate shall be amended accordingly to show the date of the most recent extension or revision, or the date of the most recent consolidation of the updated version.

4. No amendment to the approval of a type of vehicle shall be required if the new requirements referred to in paragraph 2(c) are, from a technical point of view, irrelevant to that type of vehicle or concern categories of vehicle other than the category to which it belongs.

Article 15

Specific provisions concerning systems, components or separate technical units

1. If particulars recorded in the information package have changed, the amendment shall be designated a ‘revision’.

In such cases, the approval authority shall issue the revised pages of the information package as necessary, marking each revised page to show clearly the nature of the change and the date of re-issue. A consolidated, updated version of the information package, accompanied by a detailed description of the changes, shall be deemed to meet this requirement.

2. The revision shall be designated an ‘extension’ if, in addition to the provisions of paragraph 1:

(a) further inspections or fresh tests are required;

(b) any information on the EC type-approval certificate, with the exception of its attachments, has changed;

(c) new requirements under any of the regulatory acts applicable to the approved system, component or separate technical unit enter into force.

In such cases, the approval authority shall issue a revised EC type-approval certificate denoted by an extension number, incremented in accordance with the number of successive extensions already granted. In cases where the amendment is necessitated by the application of paragraph 2(c), the third section of the approval number shall be updated.

The approval certificate shall show clearly the reason for the extension and the date of re-issue.

3. Whenever amended pages or a consolidated, updated version are issued, the index to the information package attached to the approval certificate shall be amended accordingly to show the date of the most recent extension or revision, or the date of the most recent consolidation of the updated version.

Article 16

Issue and notification of amendments

1. In the case of an extension, the approval authority shall update all relevant sections of the EC type-approval certificate, the attachments thereto, and the index to the information package. The updated certificate and its attachments shall be issued to the applicant without unjustified delay.

2. In the case of a revision, the revised documents or the consolidated, updated version, as appropriate, including the revised index to the information package, shall be issued by the approval authority to the applicant without unjustified delay.

3. The approval authority shall notify any amendment made to EC type-approvals to the approval authorities of the other Member States in accordance with the procedures referred to in Article 8.

CHAPTER VI

VALIDITY OF AN EC TYPE-APPROVAL OF VEHICLES

Article 17

Termination of validity

1. An EC type-approval of a vehicle shall cease to be valid in any of the following cases:

(a) new requirements in any regulatory act applicable to the approved vehicle become mandatory for the registration, sale or entry into service of new vehicles, and it is not possible to update the approval accordingly;

(b) production of the approved vehicle is definitively discontinued voluntarily;

(c) the validity of the approval expires by virtue of a special restriction.

2. Where only one variant within a type or one version within a variant becomes invalid, the EC type-approval of the vehicle in question shall lose validity only in so far as the particular variant or version is concerned.

3. When production of a particular type of vehicle is definitively discontinued, the manufacturer shall notify the approval authority that granted the EC type-approval for that vehicle. Upon receiving such notification, that authority shall inform the approval authorities of the other Member States accordingly within 20 working days.

Article 27 shall apply only to discontinuation in the circumstances referred to in paragraph 1(a) of this Article.

4. Without prejudice to paragraph 3, in cases where an EC type-approval of a vehicle is due to become invalid, the manufacturer shall notify the approval authority that granted the EC type-approval.

The approval authority shall without unjustified delay communicate all relevant information to the approval authorities of the other Member States so as to enable the application, where appropriate, of Article 27. That communication shall specify, in particular, the date of production and the vehicle identification number of the last vehicle produced.

CHAPTER VII

CERTIFICATE OF CONFORMITY AND MARKINGS

Article 18

Certificate of conformity

1. The manufacturer, in his capacity as the holder of an EC type-approval of a vehicle, shall deliver a certificate of conformity to accompany each vehicle, whether complete, incomplete or completed, that is manufactured in conformity with the approved vehicle type.

In the case of an incomplete or completed vehicle, the manufacturer shall complete only those items on side 2 of the certificate of conformity which have been added or changed at the current stage of approval and, if applicable, shall attach to the certificate all certificates of conformity delivered at the previous stage.

2. The certificate of conformity shall be drawn up in one of the official languages of the Community. Any Member State may request the certificate of conformity to be translated into its own language or languages.

3. The certificate of conformity shall be designed to prevent forgery. To that end, the paper used shall be protected either by coloured graphics or by a watermark in the form of the manufacturer’s identification mark.

4. The certificate of conformity shall be completed in its entirety and shall not contain restrictions as regards the use of the vehicle other than those provided for in a regulatory act.

5. The certificate of conformity as set out in Part I of Annex IX for vehicles approved in accordance with the provisions of Article 20(2) shall display in the title thereof the phrase ‘For complete/completed vehicles, type-approved in application of Article 20 (provisional approval).’.

6. The certificate of conformity, as set out in Part I of Annex IX for vehicles type-approved in accordance with Article 22 shall display in the title thereof the phrase ‘For complete/completed vehicles type-approved in small series’, and in close proximity thereto the year of production followed by a sequential number, between 1 and the limit indicated in the table set out in Annex XII, denoting, in respect of each year of production, the position of that vehicle within the production allocated for that year.

7. Without prejudice to the provisions of paragraph 1, the manufacturer may transmit data or information contained in the certificate of conformity by electronic mean to the registration authority of the Member State.

8. A duplicate of the certificate of conformity may be issued only by the manufacturer. The word ‘duplicate’ must be clearly visible on the face of any duplicate certificate.

Article 19

EC type-approval mark

1. The manufacturer of a component or separate technical unit, whether or not it is part of a system, shall affix to each component or unit manufactured in conformity with the approved type the EC type-approval mark, required by the relevant separate directive or regulation.

2. Where no EC type-approval mark is required, the manufacturer shall affix at least his trade name or trade mark, and the type number and/or an identification number.

3. The EC type-approval mark shall be in accordance with the Appendix to Annex VII.

CHAPTER VIII

NEW TECHNOLOGIES OR CONCEPTS INCOMPATIBLE WITH SEPARATE DIRECTIVES

Article 20

Exemptions for new technologies or new concepts

1. Member States may, on application by the manufacturer, grant an EC type-approval in respect of a type of system, component or separate technical unit that incorporates technologies or concepts which are incompatible with one or more regulatory acts listed in Part I of Annex IV, subject to authorisation being granted by the Commission in accordance with the procedure referred to in Article 40(3).

2. Pending the decision as to whether or not authorisation is granted, the Member State may grant a provisional approval, valid only in its territory, in respect of a type of vehicle covered by the exemption sought, provided that it informs the Commission and the other Member States thereof without delay by means of a file containing the following elements:

(a) the reasons why the technologies or concepts in question make the system, component or separate technical unit incompatible with the requirements;

(b) a description of the safety and environmental considerations concerned and the measures taken;

(c) a description of the tests, including their results, demonstrating that, by comparison with the requirements from which exemption is sought, at least an equivalent level of safety and environmental protection is ensured.

3. Other Member States may decide to accept the provisional approval referred to in paragraph 2 on their territory.

4. The Commission shall decide, in accordance with the procedure referred to in Article 40(3), whether or not to allow the Member State to grant an EC type-approval in respect of that type of vehicle.

Where appropriate, the decision shall also specify whether its validity is subject to any restrictions, such as time-limits. In all cases, the validity of the approval shall not be less than 36 months.

If the Commission decides to refuse authorisation, the Member State shall immediately give notice to the holder of the provisional type-approval referred to in paragraph 2 of this Article that the provisional approval will be revoked six months after the date of the Commission’s decision. However, vehicles manufactured in conformity with the provisional approval before it was revoked shall be permitted to be registered, sold or enter service in any Member State that accepted the provisional approval.

5. This Article does not apply where a system, component or separate technical unit complies with a UNECE Regulation to which the Community has acceded.

Article 21

Action required

1. Where the Commission finds that there are sound grounds for granting an exemption pursuant to Article 20, it shall immediately take the necessary steps to adapt the separate directives or regulations concerned to technological developments. These measures, designed to amend non-essential elements of the separate directives or regulations listed in Part I of Annex IV shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).

Where the exemption pursuant to Article 20 relates to a UNECE Regulation, the Commission shall propose an amendment to the relevant UNECE Regulation in accordance with the procedure applicable under the Revised 1958 Agreement.

2. As soon as the relevant regulatory acts have been amended, any restriction attaching to the exemption shall be lifted immediately.

If the necessary steps to adapt the regulatory acts have not been taken, the validity of an exemption may be extended, at the request of the Member State which granted the approval, by another decision adopted in accordance with the procedure referred to in Article 40(3).

CHAPTER IX

VEHICLES PRODUCED IN SMALL SERIES

Article 22

EC type-approval of small series

1. At the request of the manufacturer and within the quantitative limits set out in Section 1 of Part A of Annex XII, Member States shall grant, in accordance with the procedure referred to in Article 6(4), an EC type-approval in respect of a type of vehicle which satisfies at least the requirements listed in the Appendix to Part I of Annex IV.

2. Paragraph 1 shall not apply to special purpose vehicles.

3. EC type-approval certificates shall be numbered in accordance with Annex VII.

Article 23

National type-approval of small series

1. In the case of vehicles produced within the quantitative limits specified in Section 2 of Part A of Annex XII, Member States may waive one or more of the provisions of one or more of the regulatory acts listed in Annex IV or Annex XI, provided that they lay down relevant alternative requirements.

‘Alternative requirements’ means administrative provisions and technical requirements which aim to ensure a level of road safety and environmental protection which is equivalent to the greatest extent practicable to the level provided for by the provisions of Annex IV or Annex XI, as appropriate.

2. Member States may, in the case of the vehicles referred to in paragraph 1, waive one or more of the provisions of this Directive.

3. The provisions referred to in paragraphs 1 and 2 shall only be waived where a Member State has reasonable grounds for so doing.

4. For the purpose of type-approval of vehicles under this Article, Member States shall accept systems, components or separate technical units which are type-approved in accordance with the regulatory acts listed in Annex IV.

5. The type-approval certificate shall specify the nature of the waivers granted pursuant to paragraphs 1 and 2.

The type-approval certificate, the model for which is set out in Annex VI, shall not bear the heading ‘EC vehicle type-approval certificate’. However, type-approval certificates shall be numbered in accordance with Annex VII.

6. The validity of the type-approval shall be restricted to the territory of the Member State that granted the approval. However, if the manufacturer so requests, the approval authority shall send by registered mail or by electronic mail a copy of the type-approval certificate and its attachments to the approval authorities of the Member States designated by the manufacturer.

Within 60 days of receipt, such a Member State shall decide whether or not it accepts the type-approval. It shall formally communicate that decision to the approval authority referred to in the first subparagraph.

A Member State shall not refuse the type-approval unless it has reasonable grounds to believe that the technical provisions according to which the vehicle was approved are not equivalent to its own.

7. On request of an applicant who wishes to sell, register or put into service a vehicle in another Member State, the Member State that granted the approval shall provide the applicant with a copy of the type-approval certificate including the information package.

A Member State shall permit the sale, registration or entry into service of this vehicle unless it has reasonable grounds to believe that the technical provisions according to which the vehicle was approved are not equivalent to its own.

CHAPTER X

INDIVIDUAL APPROVALS

Article 24

Individual approvals

1. Member States may exempt a particular vehicle, whether unique or not, from compliance with one or more of the provisions of this Directive or with one or more of the regulatory acts listed in Annex IV or Annex XI, provided that they impose alternative requirements.

The provisions referred to in subparagraph 1 shall only be waived where a Member State has reasonable grounds for so doing.

‘Alternative requirements’ means administrative provisions and technical requirements which aim to ensure a level of road safety and environmental protection, which is equivalent to the greatest extent practicable to the level provided for by the provisions of Annex IV or Annex XI, as appropriate.

2. Member States shall not carry out destructive tests. They shall use any relevant information provided by the applicant establishing compliance with the alternative requirements.

3. Member States shall accept any system, component or separate technical unit EC type-approval instead of the alternative requirements.

4. An application for individual approval shall be submitted by the manufacturer or by the owner of the vehicle or by a person acting on their behalf, provided the latter is established in the Community.

5. A Member State shall grant an individual approval if the vehicle conforms to the description appended to the application and satisfies the applicable technical requirements and shall without unjustified delay issue an individual approval certificate.

The format of the individual approval certificate shall be based on the template of the EC type-approval certificate set out in Annex VI and shall contain at least the information necessary to complete the application for registration provided for in Council Directive 1999/37/EC of 29 April 1999 on the registration documents for vehicles (13). Individual approval certificates shall not bear the heading ‘EC vehicle approval’.

An individual approval certificate shall bear the vehicle identification number of the vehicle concerned.

6. The validity of an individual approval shall be restricted to the territory of the Member State that granted the approval.

Where an applicant wishes to sell, register or put into service in another Member State a vehicle which has been granted an individual approval, the Member State that granted the approval shall, on request, provide the applicant with a statement of the technical provisions against which the vehicle was approved.

With regard to a vehicle which has been granted an individual approval by a Member State in accordance with the provisions of this Article, another Member State shall permit that vehicle to be sold, registered or to enter into service unless it has reasonable grounds to believe that the technical provisions against which the vehicle was approved are not equivalent to its own.

7. At the request of the manufacturer or of the owner of the vehicle, Member States shall grant an individual approval to a vehicle which complies with the provisions of this Directive and with the regulatory acts listed in Annex IV or Annex XI, as appropriate.

In such a case, Member States shall accept the individual approval and shall permit the sale, registration and entry into service of the vehicle.

8. The provisions of this Article may apply to vehicles which have been type-approved in accordance with this Directive and which have been modified before their first registration or entry into service.

Article 25

Specific provisions

1. The procedure set out in Article 24 may apply to a particular vehicle during the successive stages of its completion in accordance with a multi-stage type-approval procedure.

2. The procedure set out in Article 24 may not replace an intermediate stage within the normal sequence of a multi-stage type-approval procedure and may not apply for the purposes of obtaining the first-stage approval of a vehicle.

CHAPTER XI

REGISTRATION, SALE AND ENTRY INTO SERVICE

Article 26

Registration, sale and entry into service of vehicles

1. Without prejudice to the provisions of Articles 29 and 30, Member States shall register, and permit the sale or entry into service of, vehicles only if they are accompanied by a valid certificate of conformity issued in accordance with Article 18.

In the case of incomplete vehicles, Member States shall permit the sale of such vehicles but may refuse their permanent registration and entry into service for such time as the vehicles remain incomplete.

2. Vehicles exempted from the requirement concerning a certificate of conformity may be registered, sold or put into service only if they satisfy the relevant technical requirements of this Directive.

3. As regards small-series vehicles, the number of vehicles registered, sold or entered into service in the course of a single year shall not exceed the number of units shown in Part A of Annex XII.

Article 27

Registration, sale and entry into service of end-of-series vehicles

1. Subject to the limits specified in Section B of Annex XII, and in respect only of a limited period of time, Member States may register and permit the sale or entry into service of vehicles conforming to a type of vehicle whose EC type-approval is no longer valid.

The first subparagraph shall apply only to vehicles within the territory of the Community which were covered by a valid EC type-approval at the time of their production, but which had not been registered or put into service before that EC type-approval lost its validity.

2. The option provided for in paragraph 1 shall be available, in the case of complete vehicles, for a period of twelve months from the date on which validity of the EC type-approval expired and, in the case of completed vehicles, for a period of eighteen months from that date.

3. A manufacturer who wishes to benefit from the provisions of paragraph 1 shall submit a request to the competent authority of each Member State concerned by the entry into service of the vehicles in question. The request must specify any technical or economic reasons preventing those vehicles from complying with the new technical requirements.

The Member States concerned shall decide, within three months of receiving such a request, whether and in what number to permit the registration of those vehicles within their territory.

4. Paragraphs 1, 2 and 3 shall apply mutatis mutandis to vehicles which were covered by a national type-approval but which had not been registered or put into service before that approval ceased to be valid, in application of Article 45, owing to the compulsory enforcement of the EC type-approval procedure.

5. Member States shall apply appropriate measures to ensure that the number of vehicles to be registered or put into service in the framework of the procedure set out in this Article is effectively monitored.

Article 28

Sale and entry into service of components and separate technical units

1. Member States shall permit the sale or entry into service of components or separate technical units if and only if they comply with the requirements of the relevant regulatory acts and are properly marked in accordance with Article 19.

2. Paragraph 1 shall not apply in the case of components or separate technical units which are specifically constructed or designed for new vehicles not covered by this Directive.

3. By way of derogation from paragraph 1, Member States may permit the sale and entry into service of components or separate technical units that have been exempted from one or more provisions of a regulatory act in application of Article 20 or are intended for mounting on vehicles covered by approvals granted under Articles 22, 23 or 24 that concern the component or separate technical unit in question.

4. By way of derogation from paragraph 1, and unless otherwise provided for in a regulatory act, Member States may permit the sale and entry into service of components or separate technical units that are intended for mounting on vehicles which, at the time of their entry into service, were not required, by this Directive or by Directive 70/156/EEC to be EC type-approved.

CHAPTER XII

SAFEGUARD CLAUSES

Article 29

Vehicles, systems, components or separate technical units in compliance with this Directive

1. If a Member State finds that new vehicles, systems, components or separate technical units, albeit in compliance with the applicable requirements or properly marked, present a serious risk to road safety, or seriously harm the environment or public health, that Member State may, for a maximum period of six months, refuse to register such vehicles or to permit the sale or entry into service in its territory of such vehicles, components or separate technical units.

In such cases, the Member State concerned shall immediately notify the manufacturer, the other Member States and the Commission accordingly, stating the reasons on which its decision is based and, in particular, whether it is the result of:

— shortcomings in the relevant regulatory acts, or

— incorrect application of the relevant requirements.

2. The Commission shall consult the parties concerned as soon as possible and, in particular, the approval authority that granted the type-approval in order to prepare the decision.

3. Where the measures referred to in paragraph 1 are attributed to shortcomings in the relevant regulatory acts, the appropriate measures shall be taken as follows:

— where separate directives or regulations listed in Part I of Annex IV are concerned, the Commission shall amend them in accordance with the regulatory procedure with scrutiny referred to in Article 40(2),

— where UNECE Regulations are concerned, the Commission shall propose the necessary draft amendments to the relevant UNECE Regulations in accordance with the procedure applicable under the Revised 1958 Agreement.

4. Where the measures referred to in paragraph 1 are attributed to incorrect application of the relevant requirements, the Commission shall take the appropriate measures to ensure compliance with such requirements.

Article 30

Vehicles, systems, components or separate technical units not in conformity with the approved type

1. If a Member State which has granted an EC type-approval finds that new vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the type it has approved, it shall take the necessary measures, including, where necessary, the withdrawal of type-approval, to ensure that production vehicles, systems, components or separate technical units, as the case may be, are brought into conformity with the approved type. The approval authority of that Member State shall advise the approval authorities of the other Member States of the measures taken.

2. For the purposes of paragraph 1, deviations from the particulars in the EC type-approval certificate or the information package shall be deemed to constitute failure to conform to the approved type.

A vehicle shall not be deemed to deviate from the approved type where tolerances are permitted by the relevant regulatory acts and those tolerances are respected.

3. If a Member State demonstrates that new vehicles, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, it may ask the Member State which granted the EC type-approval to verify that vehicles, systems, components or separate technical units in production continue to conform to the approved type. On receipt of such a request, the Member State concerned shall take the requisite action as soon as possible and in any case within six months of the date of the request.

4. The approval authority shall request the Member State which granted the system, component, separate technical unit or incomplete vehicle type-approval to take the necessary action to ensure that vehicles in production are brought back into conformity with the approved type in the following cases:

(a) in relation to an EC vehicle type-approval, where the non-conformity of a vehicle is attributable exclusively to the non-conformity of a system, component or separate technical unit;

(b) in relation to a multi-stage type-approval, where the non-conformity of a completed vehicle is attributable exclusively to the non-conformity of a system, component or separate technical unit being part of the incomplete vehicle, or of the incomplete vehicle itself.

On receipt of such a request, the Member State concerned shall take the requisite action, if necessary in conjunction with the Member State making the request, as soon as possible and in any case within six months of the date of the request. Where a failure to conform is established, the approval authority of the Member State which granted the system, component or separate technical unit EC type-approval or the approval of the incomplete vehicle shall take the measures set out in paragraph 1.

5. The approval authorities shall inform each other within 20 working days of any withdrawal of EC type-approval and of the reasons therefor.

6. If the Member State that granted EC type-approval disputes the failure to conform notified to it, the Member States concerned shall endeavour to settle the dispute. The Commission shall be kept informed and, where necessary, shall hold appropriate consultations with a view to reaching a settlement.

Article 31

Sale and entry into service of parts or equipment which are capable of posing a significant risk to the correct functioning of essential systems

1. Member States shall permit the sale, the offer for sale or entry into service of parts or equipment which are capable of posing a significant risk to the correct functioning of systems that are essential for the safety of the vehicle or for its environmental performance, only if those parts or equipment have been authorised by an approval authority in accordance with paragraphs 5 to 10.

2. Parts or equipment subject to authorisation in accordance with paragraph 1 shall be inserted in the list to be established in Annex XIII. Such a decision shall be preceded by an evaluation resulting in a report and strive for a fair balance between the following elements:

(a) the existence of a serious risk to the safety or environmental performance of vehicles fitted with the parts or equipment under consideration; and

(b) the effect on consumers and manufacturers in the after-market of the imposition under this Article of a possible authorisation requirement on the parts or equipment under consideration.

3. Paragraph 1 shall not apply to original parts or equipment which are covered by a system type-approval with respect to a vehicle and to parts or equipment which are type-approved in accordance with the provisions of one of the regulatory acts listed in Annex IV, except where those approvals relate to aspects other than those covered in paragraph 1. Paragraph 1 shall not apply to parts or equipment exclusively produced for racing vehicles not intended for use on public roads. If parts or equipment included in Annex XIII have a dual use for racing and on the road, these parts or equipment may not be sold or offered for sale to the general public for use in on-road vehicles unless they comply with the requirements of this Article.

Where appropriate, the Commission shall adopt provisions for identifying the parts or equipment referred to in this paragraph.

4. The Commission shall, after consulting stakeholders, establish the procedure and the requirements of the authorisation process referred to in paragraph 1, and adopt the provisions for the subsequent updating of the list established in Annex XIII. Those requirements shall include prescriptions for safety, environmental protection and, where needed, for testing standards. They may be based on the regulatory acts listed in Annex IV, may be developed according to the relevant state of safety, environmental and testing technology, or, if this is an appropriate way of achieving the required safety or environmental objectives, may consist of a comparison of the part or equipment with the environmental or safety performance of the original vehicle, or of any of its parts, as appropriate.

5. For the purposes of paragraph 1, the manufacturer of parts or equipment shall submit to the approval authority a test report drafted by a designated technical service which certifies that the parts or equipment for which authorisation is sought comply with the requirements referred to in paragraph 4. The manufacturer may introduce only one application per type per part with only one approval authority.

The application shall include details concerning the manufacturer of the parts or equipment, the type, identification and part numbers of the parts or equipment for which authorisation is sought, as well as the vehicle manufacturer’s name, type of vehicle and, if appropriate, years of construction or any other information permitting the identification of the vehicle for which the fitting of such parts or equipment is intended.

When the approval authority is satisfied, taking account of the test report and other evidence, that the parts or equipment in question comply with the requirements referred to in paragraph 4, it shall issue a certificate to the manufacturer without unjustified delay. This certificate shall authorise the parts or equipment to be sold, offered for sale or fitted to vehicles in the Community subject to the second subparagraph of paragraph 9.

6. Each part or piece of equipment authorised in application of this Article shall be appropriately marked.

The Commission shall establish marking and packaging requirements, as well as the model and numbering system of the certificate referred to in paragraph 5.

7. The measures referred to in paragraphs 2 to 6 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 40(2) as they are designed to amend non-essential elements of this Directive, inter alia by supplementing it.

8. The manufacturer shall inform without delay the approval authority that issued the certificate of any change affecting the conditions under which it was delivered. That approval authority shall decide whether the certificate has to be reviewed or reissued and whether fresh tests are necessary.

The manufacturer shall be responsible for ensuring that the parts and equipment are produced and continue to be produced under the conditions under which the certificate was issued.

9. Before delivering any authorisation, the approval authority shall verify the existence of satisfactory 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 back into conformity. If necessary, it shall withdraw the authorisation.

10. Any disagreement between Member States in relation to the certificates referred to in paragraph 5 shall be brought to the attention of the Commission. It shall take appropriate measures, including, where necessary, requiring the withdrawal of the authorisation, after having consulted the Member States.

11. This Article shall not be applicable to a part or piece of equipment before it is listed in Annex XIII. For any entry or group of entries in Annex XIII a reasonable transitional period shall be fixed to allow the manufacturer of the part or equipment to apply for and obtain an authorisation. At the same time a date may be fixed, where appropriate, to exclude parts and equipment designed for vehicles type-approved before that date from the application of this Article.

12. As long as a decision as to whether or not a part or piece of equipment is to be included in the list referred to in paragraph 1 has not been taken, Member States may maintain national provisions dealing with parts or equipment which are capable of posing a significant risk to the correct functioning of systems that are essential for the safety of the vehicle or its environmental performance.

Once such a decision in this regard has been taken, the national provisions dealing with the parts or equipment in question shall cease to be valid.

13. As from 29 October 2007, Member States shall not adopt new provisions dealing with parts and equipment which can affect the correct functioning of systems that are essential for the safety of the vehicle or its environmental performance.

Article 32

Recall of vehicles

1. Where a manufacturer who has been granted an EC vehicle type-approval is obliged, in application of the provisions of a regulatory act or of Directive 2001/95/EC, to recall vehicles already sold, registered or put into service because one or more systems, components or separate technical units fitted to the vehicle, whether or not duly approved in accordance with this Directive, presents a serious risk to road safety, public health or environmental protection, he shall immediately inform the approval authority that granted the vehicle approval thereof.

2. The manufacturer shall propose to the approval authority a set of appropriate remedies to neutralise the risk referred to in paragraph 1. The approval authority shall communicate the proposed measures to the authorities of the other Member States without delay.

The competent authorities shall ensure that the measures are effectively implemented in their respective territories.

3. If the measures are considered to be insufficient by the authorities concerned or have not been implemented quickly enough, they shall inform the approval authority that granted the EC vehicle type-approval without delay.

The approval authority shall then inform the manufacturer. If the approval authority which granted the EC type-approval is itself not satisfied with the measures of the manufacturer, it shall take all protective measures required, including the withdrawal of the EC vehicle type-approval where the manufacturer does not propose and implement effective corrective measures. In case of withdrawal of the EC vehicle type-approval, the concerned approval authority shall notify the manufacturer, the approval authorities of the other Member States and the Commission by registered letter or equivalent electronic means within 20 working days.

4. This Article shall also apply to parts that are not subject to any requirement under a regulatory act.

Article 33

Notification of decisions and remedies available

All decisions taken pursuant to the provisions adopted in implementation of this Directive and all decisions refusing or withdrawing EC type-approval, or refusing registration or prohibiting sales, shall state in detail the reasons on which they are based.

Any such decision shall be notified to the party concerned who shall, at the same time, be informed of the remedies available to him under the laws in force in the Member State concerned and of the time limits allowed for the exercise of such remedies.

CHAPTER XIII

INTERNATIONAL REGULATIONS

Article 34

UNECE Regulations required for EC type-approval

1. UNECE Regulations to which the Community has acceded and which are listed in Part I of Annex IV and in Annex XI are part of the EC type-approval of a vehicle in the same way as the separate directives or regulations. They shall apply to the categories of vehicles listed in the relevant columns in the table of Part I of Annex IV and Annex XI.

2. When the Community has decided to apply on a compulsory basis a UNECE Regulation for the purpose of EC vehicle type-approval in accordance with Article 4(4) of Decision 97/836/EC, the annexes to this Directive shall be amended as appropriate in accordance with the regulatory procedure with scrutiny referred to in Article 40(2) of this Directive. The act amending the Annexes to this Directive shall also specify the dates of compulsory application of the UNECE Regulation or of its amendments. Member States shall repeal or adapt any national legislation that is incompatible with the UNECE Regulation in question.

Where such a UNECE Regulation replaces an existing separate directive or regulation, the relevant entry in Part I of Annex IV and in Annex XI shall be replaced by the number of the UNECE Regulation and the corresponding entry in Part II of Annex IV shall be deleted in accordance with the same procedure.

3. In the cases referred to in the second subparagraph of paragraph 2, the separate directive or regulation replaced by the UNECE Regulation shall be repealed in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).

Where a separate directive is repealed, Member States shall repeal any national legislation that was adopted for the transposition of that directive.

4. Direct references may be made in this Directive or in the separate directives or regulations to international standards and regulations without reproducing them in the Community legal framework.

Article 35

Equivalence of UNECE Regulations with directives or regulations

1. The UNECE Regulations listed in Part II of Annex IV are recognised as being equivalent to the corresponding separate directives or regulations in as much as they share the same scope and subject matter.

The approval authorities of the Member States shall accept approvals granted in accordance with those UNECE Regulations and, where applicable, the pertaining approval marks, in lieu of the corresponding approvals and approval marks granted in accordance with the equivalent separate directive or regulation.

2. Where the Community has decided to apply, for the purposes of paragraph 1, a new UNECE Regulation or a UNECE Regulation as amended, Part II of Annex IV shall be amended as appropriate. These measures, designed to amend non-essential elements of this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).

Article 36

Equivalence with other regulations

The Council may, acting by qualified majority on a proposal from the Commission, recognise the equivalence between the conditions or provisions for EC type-approval of systems, components and separate technical units established by this Directive and the procedures established by international regulations or regulations of third countries, in the framework of multilateral or bilateral agreements between the Community and third countries.

CHAPTER XIV

PROVISION OF TECHNICAL INFORMATION

Article 37

Information intended for users

1. The manufacturer may not supply any technical information related to the particulars provided for in this Directive or in the regulatory acts listed in Annex IV which diverges from the particulars approved by the approval authority.

2. Where a regulatory act makes specific provisions for so doing, the manufacturer shall make available to users all relevant information and necessary instructions describing any special conditions or restrictions attaching to the use of a vehicle, a component or a separate technical unit.

That information shall be supplied in the official languages of the Community. It shall be provided, in agreement with the approval authority, in an appropriate supporting document, such as the owner’s manual or the maintenance book.

Article 38

Information intended for manufacturers of components or separate technical units

1. The vehicle manufacturer shall make available to the manufacturers of components or separate technical units all those particulars including, as the case may be, drawings specifically listed in the annex or appendix to a regulatory act that are necessary for EC type-approval of components or separate technical units, or necessary to obtain an authorisation under Article 31.

The vehicle manufacturer may impose a binding agreement on the manufacturers of components or separate technical units to protect the confidentiality of any information that is not in the public domain, including what is related to intellectual property rights.

2. The manufacturer of components or separate technical units, in his capacity as the holder of an EC type-approval certificate which, in accordance with Article 10(4), includes restrictions on use or special mounting conditions or both, shall provide all the detailed information thereon to the vehicle manufacturer.

Where a regulatory act makes provision for so doing, the manufacturer of components or separate technical units shall provide, together with the components or separate technical units produced, instructions regarding restrictions on use or special mounting conditions or both.

CHAPTER XV

IMPLEMENTATION MEASURES AND AMENDMENTS

Article 39

Implementation measures and amendments to this Directive and the separate directives and regulations

1. The Commission shall adopt the measures necessary for the implementation of each separate directive or regulation in compliance with the rules laid down in each directive or regulation concerned.

2. The Commission shall adopt amendments to the annexes to this Directive or to the provisions of the separate directives or regulations listed in Part I of Annex IV, which are necessary to adapt them to the development of scientific and technical knowledge or to the specific needs of persons with disabilities.

3. The Commission shall adopt amendments to this Directive which are necessary to lay down technical requirements for small series vehicles, vehicles approved under the individual approval procedure and special purpose vehicles.

4. When the Commission becomes aware of serious risks to road users or to the environment, which require urgent measures, it may amend the provisions of the separate directives or regulations listed in Part I of Annex IV.

5. The Commission shall adopt amendments which are necessary in the interest of good administration and in particular those needed to ensure the coherence of the separate directives or regulations listed in Part I of Annex IV either amongst themselves or with other pieces of Community law.

6. When, in application of Decision 97/836/EC, new UNECE Regulations or amendments to existing UNECE Regulations to which the Community has acceded are adopted, the Commission shall amend the annexes to this Directive accordingly.

7. Each new separate directive or regulation shall introduce the appropriate amendments to the annexes to this Directive.

8. The annexes to this Directive may be amended by means of regulations.

9. Measures referred to in this Article shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 40(2) as they are designed to amend non-essential elements of this Directive or of the separate directives and regulations, inter alia by supplementing them.

Article 40

Committee

1. The Commission shall be assisted by a committee referred to as the ‘Technical Committee — Motor Vehicles’ (TCMV).

2. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

CHAPTER XVI

DESIGNATION AND NOTIFICATION OF TECHNICAL SERVICES

Article 41

Designation of technical services

1. When a Member State designates a technical service, the latter shall comply with the provisions of this Directive.

2. The technical services shall carry out themselves or supervise the tests required for approval or inspections specified in this Directive or in a regulatory act listed in Annex IV, except where alternative procedures are specifically permitted. They may not conduct tests or inspections for which they have not been duly designated.

3. The technical services shall fall into one or more of the four following categories of activities, depending on their field of competence:

(a) category A, technical services which carry out in their own facilities the tests referred to in this Directive and in the regulatory acts listed in Annex IV;

(b) category B, technical services which supervise the tests referred to in this Directive and in the regulatory acts listed in Annex IV, performed in the manufacturer’s facilities or in the facilities of a third party;

(c) category C, technical services which assess and monitor on a regular basis the manufacturer’s procedures for controlling conformity of production;

(d) category D, technical services which supervise or perform tests or inspections in the framework of the surveillance of conformity of production.

4. Technical services shall demonstrate appropriate skills, specific technical knowledge and proven experience in the specific fields covered by this Directive and the regulatory acts listed in Annex IV.

In addition, technical services shall comply with the standards listed in Appendix 1 to Annex V which are relevant for the activities they carry out. However, this requirement does not apply for the purposes of the last stage of a multi-stage type-approval procedure as referred to in Article 25(1).

5. An approval authority may act as a technical service for one or more of the activities referred to in paragraph 3.

6. A manufacturer or a subcontracting party acting on his behalf may be designated as a technical service for category A activities with regard to the regulatory acts listed in Annex XV.

The Commission shall amend the list of these regulatory acts where necessary in accordance with the regulatory procedure with scrutiny referred to in Article 40(2).

7. The entities referred to in paragraphs 5 and 6 shall comply with the provisions of this Article.

8. Technical services, other than those designated in accordance with paragraph 6, of a third country may be notified for the purposes of Article 43 only in the framework of a bilateral agreement between the Community and the third country in question.

Article 42

Assessment of the skills of the technical services

1. The skills referred to in Article 41 shall be demonstrated by an assessment report established by a competent authority. This may include a certificate of accreditation issued by an accreditation body.

2. The assessment on which the report referred to in paragraph 1 is based shall be conducted in accordance with the provisions of Appendix 2 to Annex V.

The assessment report shall be reviewed after a maximum period of three years.

3. The assessment report shall be communicated to the Commission upon request.

4. The approval authority which acts as a technical service shall demonstrate compliance through documentary evidence.

This includes an assessment conducted by auditors independent of the activity being assessed. Such auditors may be from within the same organisation provided that they are managed autonomously from personnel undertaking the assessed activity.

5. A manufacturer or a subcontracting party acting on his behalf, designated as a technical service, shall comply with the relevant provisions of this Article.

Article 43

Procedures for notification

1. Member States shall notify to the Commission the name, the address including electronic address, the responsible persons and the category of activities with respect to each designated technical service. They shall notify it of any subsequent modifications thereto.

The notification act shall state in respect of which regulatory acts the technical services have been designated.

2. A technical service may conduct the activities described in Article 41 for the purposes of type-approval only if it has been notified beforehand to the Commission.

3. The same technical service may be designated and notified by several Member States irrespective of the category of activities which it conducts.

4. Where a specific organisation or competent body, the activity of which is not included in those referred to in Article 41, needs to be designated in application of a regulatory act, the notification shall be made in accordance with the provisions of this Article.

5. The Commission shall publish a list and details regarding the approval authorities and technical services on its web-site.

CHAPTER XVII

FINAL PROVISIONS

Article 44

Transitional provisions

1. Pending the necessary amendments to this Directive in order to include vehicles not yet covered or to complete the administrative and technical provisions regarding type-approval of vehicles other than M1 produced in small series, and to lay down harmonised administrative and technical provisions regarding the individual approval procedure, and pending expiry of the transitional periods provided for in Article 45, Member States shall continue to grant national approvals for those vehicles, provided that such approvals are based on the harmonised technical requirements laid down in this Directive.

2. On application by the manufacturer or, in the case of individual approval, by the owner of the vehicle and on submission of the information required, the Member State concerned shall complete and issue the type-approval certificate or the individual approval certificate as appropriate. The certificate shall be issued to the applicant.

With respect to vehicles of the same type, other Member States shall accept a certified true copy as proof that the requisite tests have been carried out.

3. Where a particular vehicle covered by an individual approval has to be registered in another Member State, that Member State may require, from the approval authority that has issued the individual approval, any additional information stating in detail the nature of the technical requirements satisfied by that particular vehicle.

4. Pending the harmonisation of registration and taxation systems of the Member States in relation to vehicles covered by this Directive, Member States may use national codes in order to facilitate registration and taxation in their territory. For this purpose, Member States may subdivide the ver