Article 8 Duties of the Member States

Article 8

Duties of the Member States

1.  Member States shall appoint the competent authority or authorities responsible for communicating and exchanging information relating to the management of this Regulation and inform the Commission of the full name and address of these authorities.

2.  Each Member State shall notify to the other Member States and to the Commission the list of approved laboratories, with their full name and address, that are competent and authorised to carry out the tests required by this Regulation. Member States shall demonstrate the competence of the above laboratories according to the standard EN ISO/IEC 17025 mentioned in Annex I.1. This requirement shall be deemed to be fulfilled if the Member State has verified the compliance of laboratories with the principles of good laboratory practice in accordance with Article 2 of Directive 2004/9/EC.

3.  Where the competent authority of a Member State has grounds for believing that an approved laboratory does not possess the competence referred to in paragraph 2, it shall raise the matter in the Committee referred to in Article 12. If the Commission decides that the laboratory does not possess the required competence, the name of the approved laboratory shall be removed from the list referred to in paragraph 4. Article 15(2) shall apply, except in the case of laboratories claiming compliance with the requirements of good laboratory practice, for which the non-compliance provisions of Articles 5 and 6 of Directive 2004/9/EC shall apply.

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4.  The Commission shall make publicly available the lists of competent authorities, mentioned in paragraph 1, and of approved laboratories, mentioned in paragraph 2.

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