22.5.2008 Official Journal of the European Union L 133/1 (Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory) REGULATIONS COMMISSION REGULATION (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Commu- nity, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (!), and in particular Article 7(4) and (5) thereof, After consulting the European Food Safety Authority in accordance with Article 7(4) and (5) of Regulation (EC) No 1831/2003, Whereas: 1 ) e O) L 268, 18.10.2003, p. 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 (%) 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 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (O] L 59, 5.3.2005, p. 68). OJ L 64, 7.3.1987, p. 19. Repealed by Regulation (EC) No 1831/ 2003. 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 estab- lished for each category of additives referred to in Arti- cle 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