Guidance for the preparation of dossiers for additives already authorised for use in food

This guidance document follows the structure and definitions of Regulation (EC) No 1831/2003 and its implementing rules (Regulation (EC) No 429/2008). It is intended to assist the applicant in the preparation and the presentation of its application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003. This document does not substitute for the obligation of an applicant to comply with the requirements of Regulation (EC) No 1831/2003 and its implementing rules. Dossiers for additives already authorised as food additives or approved as components of foodstuffs in the European Union and intended for use as a feed additive should follow the respective guidance documents for the feed additive categories to which they are assigned (technological, sensory, nutritional and zootechnical additives). However, the “simplified procedure” foreseen in Article 7 of Regulation (EC) No 1831/2003 for additives already authorised for use in food allows some extrapolations and consequently exemptions from the requirements laid out in the EFSA guidance documents. These exemptions are detailed here. The full text of the authorisation as food additive or approval as a food component should be attached to the dossier.