EFSA has published an updated guidance document to assist companies to assess the safety for the consumer when they want to have their feed additive authorised.
The document describes what companies have to prepare and present, based on Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. The document specifically covers the assessment of the safety for the consumer, which has been updated after a public consolation in 2017.
This document does not substitute the obligation of an applicant to comply with the requirements of Regulation (EC) No 1831/2003 and its implementing rules, as this specific document only provides guidance on how to assess the safety for the consumer.
This guidance is divided into 5 sections.
- The introduction provides the principles of the assessment of consumer safety.
- A catalogue of studies that may be needed is provided in Section 2
- The requirements for the different additives are listed in Section 3.
- Section 4 describes how to derive a highest safe intake for the consumer based on the outcome of the above studies. The safety for the consumer is assessed by comparing the exposure of the consumer to residues in food products to this safe intake.
- Finally, Section 5 describes how to calculate maximum residue levels (MRLs), when needed.
To read the full guidance document, visit the EFSA Journal website.
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