This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1613/full
This guidance document is applicable for applications submitted until 26 March 2021.
This document provides guidance to applicants submitting applications for authorisation of additives for use in animal nutrition within the scope of Regulation (EC) No 1831/2003 and Commission Regulation (EC) No 429/2008, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and submission of the dossier to support an application for a new authorisation, for the modification or the renewal of an existing authorisation of a feed additive. The procedure and the associated timelines for handling applications for authorisation, from their submission to the adoption and publication of the EFSA scientific opinion are also described. The document ultimately presents the different possibilities to interact with EFSA staff and the support initiatives available during the different stages of the application life-cycle.