Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilDangos y teitl llawn

Article 9 U.K. Authorisation by the Community

1. Within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft Regulation to grant authorisation or to deny authorisation. This draft shall take into account the requirements of Article 5(2) and (3), Community law and other legitimate factors relevant to the matter under consideration and in particular benefits for animal health and welfare and for the consumer of animal products.

Where the draft is not in accordance with the opinion of the Authority, it shall provide an explanation of the reasons for the differences.

In exceptionally complex cases, the three-month deadline may be extended.

2. The draft shall be adopted in accordance with the procedure referred to in Article 22(2).

3. Rules for the implementation of this Article and in particular concerning an identification number for authorised additives may be established in accordance with the procedure referred to in Article 22(2).

4. The Commission shall without delay inform the applicant of the Regulation adopted in accordance with paragraph 2.

5. A Regulation granting the authorisation shall include the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number.

6. A Regulation granting authorisation for additives belonging to categories (d) and (e) referred to in Article 6(1) and also for additives consisting of, containing or produced from GMOs, shall include the name of the holder of the authorisation, and, where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC(1).

7. Where the levels of residues of an additive in food from animals fed with that additive might have a detrimental effect on human health, the Regulation shall include MRLs for the active substance or for its metabolites in the relevant foodstuffs of animal origin. In this case the active substance shall be considered for the purposes of Council Directive 96/23/EC(2) as falling under Annex I to that Directive. Where an MRL for the substance concerned has already been established in Community rules, that MRL shall also apply to residues of the active substance or its metabolites originating from the use of the substance as a feed additive.

8. The authorisation granted in accordance with the procedure laid down in this Regulation shall be valid throughout the Community for 10 years and shall be renewable in accordance with Article 14. The authorised feed additive shall be entered in the Register referred to in Article 17 (hereinafter referred to as the Register). Each entry in the Register shall state the date of authorisation and shall include the particulars referred to in paragraphs 5, 6 and 7.

9. The granting of authorisation shall be without prejudice to the general civil and criminal liability of any feed operator in respect of the feed additive concerned.

(1)

See page 24 of this Official Journal.

(2)

OJ L 125, 23.5.1996, p. 10.