Regulation 2008/429 - Detailed rules for the implementation of Regulation 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives - Main contents

EN

Official Journal of the European Union

L 133/1

It is necessary to establish implementing rules concerning the procedure for the authorisation of feed additives under Regulation (EC) No 1831/2003, including rules for the preparation and the presentation of the applications and for the assessment and the authorisation of such additives. These rules are intended to replace the provisions laid down in the Annex to Council Directive 87/153/EEC (2) fixing guidelines for the assessment of additives in animal nutrition.

Those rules should provide for the requirements to be satisfied by the dossier accompanying the application. They should, in particular, set out the scientific data to be submitted for the identification and the characterisation of the additive concerned and the studies to be submitted to demonstrate its efficacy and its safety for humans, animals and the environment in view of the verification and assessment of the applications for authorisation by the European Food Safety Authority (the Authority).

Depending on the nature of the additive or its requested conditions of use, the extent of the studies necessary to evaluate its properties or its effects may vary. Operators should, therefore, be granted some flexibility with respect to the kind of studies and material to be submitted to demonstrate the safety and the efficacy of the additive concerned. Operators making use of that flexibility should have to justify their choice in the dossier.

The Authority should have the possibility to request supplementary information, where appropriate, in order to determine whether the additive complies with the conditions for authorisation referred to in Article 5 of Regulation (EC) No 1831/2003.

It is indispensable to apply appropriate quality standards when developing dossiers for additives intended for use in feed or water to ensure that the results of laboratory tests are not disputed.

Where necessary, specific requirements should be established for each category of additives referred to in Article 6(1) of Regulation (EC) No 1831/2003.

To stimulate efforts to obtain authorisations for minor species while keeping the necessary level of safety, specific conditions should be provided for taking into account the possibility of extrapolating the results of the studies carried out on major species to minor species.

Implementing rules concerning applications for authorisation should take into account different requirements for food-producing animals and other animals, for which aspects regarding the safety evaluation for the human consumer are not relevant.

Recourse to procedures involving the use of laboratory animals for experimental or other scientific purposes and animal testing according to Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of...