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Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (Text with EEA relevance)
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Version Superseded: 31/12/2022
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Regulation (EU) 2018/858 of the European Parliament and of the Council, CHAPTER IV is up to date with all changes known to be in force on or before 05 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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1.For each type of vehicle, system, component or separate technical unit, only one EU type-approval may be granted.
2.An approval authority, having received an application in accordance with Article 23, shall only grant an EU type-approval after having verified all of the following:
(a)the conformity of production arrangements referred to in Article 31;
(b)that the declaration referred to in Article 23(3) has been submitted;
(c)the compliance of the type of vehicle, system, component or separate technical unit with the applicable requirements;
(d)in the case of whole-vehicle type-approvals in accordance with the step-by-step, mixed or multi-stage type-approval procedures, the approval authority shall verify, in accordance with Article 22(4), that the systems, components and separate technical units are covered by separate and valid type-approvals that have been granted pursuant to the requirements applicable at the time of the granting of the whole-vehicle type-approval.
3.The procedures with respect to EU type-approval, that are set out in Annex III, and the procedures with respect to multi-stage type-approval, set out in Annex IX, shall apply.
The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annexes III and IX to take into account regulatory and technological developments by updating the procedures therein with respect to EU type-approval and multi-stage type-approval.
4.The approval authority shall put together an information package consisting of the information folder referred to in Article 24, accompanied by the test reports and all other documents that were added to the information folder by the technical service or by the approval authority while carrying out their tasks.
The information package may be kept electronically. It shall contain an index that clearly indicates all of the pages and the format of each document, and that chronologically records any changes to the EU type-approval.
The approval authority shall keep the information package available for a period of 10 years after the end of the validity of the EU type-approval concerned.
5.The approval authority shall refuse to grant an EU type-approval where it finds that a type of vehicle, system, component or separate technical unit that complies with the applicable requirements nonetheless presents a serious risk to safety or may seriously harm the environment or public health. In such case, it shall immediately send to the approval authorities of the other Member States and to the Commission a detailed file explaining the reasons for its decision and setting out the evidence for its findings.
6.In accordance with Article 22(4), in the case of step-by-step, mixed and multi-stage type-approval procedures, the approval authority shall refuse to grant an EU type-approval where it finds that systems, components or separate technical units do not comply with the requirements set out in this Regulation.
The approval authority shall ask the approval authorities that granted type-approvals for the systems, components, or separate technical units, to act in accordance with Article 54(2).
1.The approval authority shall, when issuing or amending the EU type-approval certificate, make available to the approval authorities of the other Member States, to the market surveillance authorities, and to the Commission, a copy of the EU type-approval certificate for each type of vehicle, system, component and separate technical unit for which it has granted a type-approval and its attachments, including the test reports referred to in Article 30. That copy shall be made available by means of the common secure electronic exchange system in accordance with the implementing acts referred to in paragraph 3 of this Article.
2.The approval authority shall without delay inform the approval authorities of the other Member States and the Commission of its refusal or withdrawal of any EU type-approval, stating the reasons for its decision, by means of the common secure electronic exchange system in accordance with the implementing acts referred to in paragraph 3.
3.As regards the common secure electronic exchange system, the Commission shall adopt implementing acts laying down the format of the electronic documents that are to be made available, the exchange mechanism, the procedures to inform authorities on the granting of EU type-approvals, on amendments, refusals and withdrawals thereof and on the relevant security measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.
1.The EU type-approval certificate shall contain the following attachments:
(a)the information package referred to in Article 26(4);
(b)the test reports referred to in Article 30 in the case of a system, component or separate technical unit type-approval, or the test results sheet in the case of whole-vehicle type-approval;
(c)in the case of the whole-vehicle type-approval, the name and the specimen of the signature of the person or persons authorised to sign the certificates of conformity and a statement of their position in the company;
(d)in the case of the whole-vehicle type-approval, a filled-out specimen of the certificate of conformity of the vehicle type.
2.The EU type-approval certificate shall be given a unique number in accordance with a harmonised numbering system, which shall at least allow for the identification of the Member State which granted the EU type-approval and for the identification of the requirements to which the type of vehicle, system, component or separate technical unit conforms.
3.The Commission shall adopt implementing acts laying down the templates for the EU type-approval certificate, the harmonised numbering system, and the test result sheet, respectively, including providing the relevant electronic formats. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.
4.In respect of each type of vehicle, system, component and separate technical unit, the approval authority shall:
(a)complete all the relevant sections of the EU type-approval certificate, including its attachments;
(b)compile the index to the information package as referred to in Article 26(4);
(c)issue the completed EU type-approval certificate and its attachments to the manufacturer without delay.
5.In the case of an EU type-approval, the validity of which has been restricted in accordance with Article 39, Article 43 or Part III of Annex II, or in relation to which certain provisions of this Regulation or of the regulatory acts listed in Annex II do not apply, the EU type-approval certificate shall specify those restrictions or the relevant provisions that do not apply.
6.Where a manufacturer of a vehicle chooses the mixed type-approval procedure, the approval authority shall complete the information package as referred to in Article 26(4) with the references to the test reports referred to in Article 30 for the systems, components or separate technical units for which no EU type-approval certificate has been issued. The approval authority shall also clearly identify in the information package the technical requirements of the regulatory acts listed in Annex II against which the vehicle was tested.
7.Where a manufacturer of a vehicle chooses the single-step type-approval procedure, the approval authority shall attach to the EU type-approval certificate a list of relevant regulatory acts in accordance with the template provided in the implementing acts referred to in paragraph 3.
1.An EU type-approval shall be granted in respect of a system, component or separate technical unit that conforms to the particulars in the information folder referred to in Article 24 and that meets the technical requirements laid down in the relevant regulatory acts listed in Annex II.
2.Where components or separate technical units, whether or not intended for repair, servicing or maintenance, are also covered by a system type-approval with respect to a vehicle, no additional component or separate technical unit type-approval shall be required unless such type-approval is provided for under the relevant regulatory acts listed in Annex II.
3.Where a component or separate technical unit fulfils its function or offers a specific feature only in conjunction with other parts of the vehicle, thereby making it possible to verify compliance only where the component or separate technical unit operates in conjunction with those other vehicle parts, the scope of the EU type-approval of the component or the separate technical unit shall be restricted accordingly.
In such cases, the EU type-approval certificate shall specify any restrictions on the use of the component or the separate technical unit, and shall indicate the special conditions for fitting that component or separate technical unit in a vehicle.
Where that component or separate technical unit is fitted in a vehicle, the approval authority shall verify, at the time of the approval of the vehicle, that the component or separate technical unit complies with all applicable restrictions on the use or conditions for fitting.
1.For the purpose of granting EU type-approvals, the approval authority shall verify compliance with the technical requirements of this Regulation by means of appropriate tests that are performed by its technical services.
2.The fundamental elements of the tests, including the technical requirements for which compliance was verified by the tests, shall be recorded in a test report.
3.The Commission shall adopt implementing acts laying down the format of the test reports. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 83(2). The first such implementing act shall be adopted by 5 July 2020.
4.The manufacturer shall make available to the approval authorities and provide to the technical services concerned the vehicles, systems, components or separate technical units that are required under the relevant regulatory acts listed in Annex II for the performance of the required tests.
5.The required tests shall be performed on vehicles, systems, components and separate technical units that are representative of the type to be approved.
6.Where a range of values is provided for the parameters and for the conditions used for the performance of the appropriate tests referred to in paragraph 1, the technical services may choose any value within that range.
7.At the request of the manufacturer, and subject to the agreement of the approval authority, virtual testing methods may be used in accordance with Annex VIII as alternatives to the tests referred to in paragraph 1.
8.The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex VIII to take into account technical and regulatory developments by updating the list of regulatory acts in respect of which virtual testing methods may be used by a manufacturer or a technical service and the specific conditions under which those virtual testing methods are to be used.
1.An approval authority that has granted an EU type-approval shall take the necessary measures in accordance with Annex IV to verify, if necessary in cooperation with the approval authorities of the other Member States, that the manufacturer produces the vehicles, systems, components or separate technical units in conformity with the approved type.
2.An approval authority that has granted a whole-vehicle type-approval shall verify a statistically relevant number of samples of vehicles and certificates of conformity on their compliance with Articles 36 and 37 and shall verify that the data in those certificates of conformity are correct.
3.An approval authority that has granted an EU type-approval shall take the necessary measures to verify, if necessary in cooperation with the approval authorities of the other Member States, that the arrangements referred to in paragraphs 1 and 2 of this Article continue to be adequate so that vehicles, systems, components or separate technical units in production continue to conform to the approved type and that certificates of conformity continue to comply with Articles 36 and 37.
4.In order to verify that a vehicle, system, component or separate technical unit conforms to the approved type, the approval authority that granted the EU type-approval shall take the necessary measures to carry out the checks or tests on samples taken at the manufacturer's premises, including production facilities that are required for EU type-approval.
In accordance with Annex IV, the approval authority shall take the necessary measures to carry out such checks or tests with the frequency set out in the regulatory acts listed in Annex II, or, if no frequency is specified in those acts, at least once every three years.
5.In order to verify that a vehicle, system, component or separate technical unit conforms to the approved type, the approval authority or the technical services shall:
(a)if a range of values is provided for in the test procedures laid down in the relevant regulatory acts listed in Annex II, set the values in a random manner within the provided range when carrying out checks or tests; and
(b)have access to the software, algorithms, documentation and any additional information in accordance with Article 25(4).
6.An approval authority that has granted an EU type-approval shall take the necessary measures to verify that the manufacturer complies with the obligations set out in Chapter XIV. It shall verify in particular whether, in order to comply with those obligations, the manufacturer has amended or supplemented the vehicle OBD information and vehicle repair and maintenance information.
7.Where an approval authority that has granted an EU type-approval establishes that the manufacturer no longer produces the vehicles, systems, components or separate technical units in conformity with the approved type or with the requirements of this Regulation, or establishes that the certificates of conformity no longer comply with Articles 36 and 37, even though production is continued, it shall take the necessary measures to ensure that the arrangements for conformity of production are followed correctly or withdraw the type-approval. The approval authority may decide to take all necessary restrictive measures in accordance with Chapter XI.
8.The Commission is empowered to adopt delegated acts in accordance with Article 82, amending Annex IV to take account of technological and regulatory developments by updating the conformity of production procedures.
1.The fees for EU type-approval activities shall be levied on the manufacturers who have applied for EU type-approval in the Member State concerned.
The Member State shall ensure that sufficient resources are available to cover the costs for market surveillance activities. Without prejudice to national law, those costs may be recovered by fees that can be levied by the Member State in which the vehicles are placed on the market.
2.The Member States may levy administrative fees on technical services applying to be designated to cover wholly or partly the costs relating to the activities exercised by the national authorities responsible for technical services in accordance with this Regulation.
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