Article 9 Authorisation by the appropriate authority...F1F9F10

Within three months of receipt of the opinion of the Food Safety Authority, the appropriate authority must determine whether to authorise the feed additive and the conditions upon which the feed additive is authorised. In making its determination, the appropriate authority must take into account the requirements of Article 5(2) and (3), F2assimilated 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. F3F4Where the appropriate authority determines that the feed additive is to be authorised, the authorisation must include the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number. Where the authorisation is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation of the reasons for the differences. Where, in the opinion of the appropriate authority, the application raises exceptionally complex issues, the three-month deadline may be extended.

Rules for the implementation of this Article and in particular concerning an identification number for authorised additives may be prescribed by the appropriate authority.

The appropriate authority must without delay inform the applicant of the F5authorisation made in accordance with paragraph 1.

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An 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, must 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 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.

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 authorisation must include MRLs for the active substance or for its metabolites in the relevant foodstuffs of animal origin. In this case the active substance must be considered for the purposes of Council Directive 96/23/EC as falling under Annex 1 to that Directive. Where an MRL for the substance concerned has already been established in F7assimilated law, that MRL must also apply to residues of the active substance or its metabolites originating from the use of the substance as a feed additive.

Where the appropriate authority determines that a feed additive is, or is not, to be authorised: