Feed additives applications: frequently asked questions

EFSA provides scientific advice on the safety and/or efficacy of additives and products or substances used in animal feed.

Frequently Asked Questions

You can find some general frequently asked questions in our Connect.EFSA dedicated FAQ page.

1. Are the requirements the same for all feed additive applications?

No, the requirements vary according to the different categories of feed additives and types of authorisations. Details are included in Annexes II and III of Regulation EC 429/2008, which provides the list and the characteristics of studies and information on feed additives to be submitted:

New feed additives or a new uses of a feed additive – for applications requesting authorisation for a new feed additive or a new use of a feed additive, Article 4(1) of Regulation EC 1831/2003) applies. For the preparation of the application and the technical dossier.

Authorisation holder wishing to change the terms of their authorisation – for applications requesting change(s) in the terms of authorisation, Article 13(3) of Regulation EC 1831/2003 applies. For the preparation of the application and the technical dossier.

Renewal of the authorisation period for feed additives – under Article 14(1) of Regulation EC 1831/2003, authorisations under this Regulation are renewable for 10-year periods. An application for renewal should be sent to the European Commission at the latest one year before the expiry date of the authorisation. The particulars and documents to be sent to EFSA are indicated in Article 14(2) of Regulation EC 1831/2003 and in point 10 of Annex III of Regulation EC 429/2008.

Re-evaluation of a feed additive –The submission of applications for the re-evaluation of feed additives under Article 10(2) of Regulation EC 1831/2003 ended on 7 November 2010 (additives authorised without a time limit or authorised by Directive 82/471/EEC). Applications for the re-evaluation of products (linked to a holder of an authorisation or with a limited authorisation period) have to be submitted one year before the expiry of the authorisation granted under Directive 70/524/EEC.

2. Short cuts for applicants