On April 6, 2017, EFSA opened for public consultation its draft guidance for the assessment of the safety of feed additives for target species. This document aims to complement Regulation (EC) 429/2008 to support applicants in the preparation and submission of an application and technical dossier for the authorization of a feed additive in accordance with Regulation (EC) No 1831/2003. The EFSA draft guidance aims to encourage the reduction and replacement of tests using experimental animals. For this purpose, the draft guidance provides a list of feed additives for which safety can be presumed without additional studies. For all other additives, the EFSA draft guidance recommends as a first step the assessment of the safety of the feed additive by an extensive literature review. The draft guidance recommends that applicants use toxicity data (existing or new) from repeated dose studies in laboratory animals or conduct tolerance studies in target animals only if safety cannot be established through literature searches. Comments are due May 31, 2017.
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