SME Chamber

Motor vehicles and their trailers


Directive 2007/46/EC establishes a harmonised framework containing the administrative provisions and general technical requirements for all new vehicles, systems, components and separate technical units.


As a result of the effects of globalisation on the automotive sector, the demand for vehicles built outside the Union is growing significantly. Member states have put in place administrative procedures and technical requirements under national law for the approval of vehicles imported from third countries. As the procedures and requirements differ from one Member state to another, this situation creates distortion in the functioning of the internal market. It is therefore necessary to lay down appropriate harmonised measures.

Harmonised administrative and technical provisions regarding individual approvals should be laid down in a first step with respect to vehicles produced in large series in or for third countries.

Article 24 of Directive 2007/46/EC allows Member States to waive certain provisions of this Directive as well as of the Regulatory Acts listed in Annex IV of that Directive for the purpose of approval of individual vehicles. The proper functioning of the internal market requires however that the same technical and administrative waivers be granted at European level. It is therefore necessary to lay down which provisions of European law may be waived.

Article 24 allows also Member States to impose alternative requirements to European law which aim to ensure a level of road safety and environmental protection which is equivalent to the greatest extent practicable to the level provided by European law. Assuming that vehicles produced in series for third countries with a view to being put into service into domestic markets are built in accordance with the technical legislation in force in the respective countries of origin or destination, it is therefore appropriate to take into account such requirements. The appropriate information and the necessary expertise is available in order to demonstrate that those requirements could ensure a level of road safety and environmental protection required in the Union. It is therefore appropriate to consider as equivalent a number of requirements in force in the third countries for the purpose of individual approval.

Member states have national individual approval schemes in place at the time of the adoption of this Regulation for vehicles produced in large series and originally intended for registration in third countries. Those approval schemes may continue to apply, however their validity is restricted to the territory of the Member state that granted the approval and other Member states may refuse such approvals.

It is appropriate with a view to ensuring the proper operation of the approval system to update the annexes to Directive 2007/46/EC in order to lay down technical requirements for vehicles to be approved under the individual approval procedure. Annexes IV and VI to Directive 2007/46/EC should therefore be amended accordingly.

For the purpose of individual approval, a vehicle is deemed to be new where: it has never been registered previously or it has been registered for less than six months at the time of application for individual approval. A vehicle shall be considered registered where it has obtained a permanent, temporary or short term administrative authorisation for entry  into service in road traffic, involving its identification and the issuing of a registration number.

Who and what products will be effected

Type Approval Authorities, Manufacturers, Authorised Representatives, and Importers, of motor vehicles.


Feedback by noon of Friday 7th January 2011. To:

Regulatory Affairs Directorate,


Second Floor, Evans Building, Merchants Street,

Valletta, VLT 1179,



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