EFSA organised a technical meeting with stakeholders of feed additive applications on 14-15 November in Parma. The overall aim of this technical meeting was to discuss questions on the scientific evaluation of applications related to feed additives. This covered mainly the recently updated FEEDAP guidance documents on characterisation of microbial products, consumer safety, safety for the environment and efficacy. In addition, participants discussed the critical issues of the assessment of safety for users. To this end, the following documents served as the basis for the discussion:
- Guidance on the characterisation of microorganisms used as feed additives or as production organisms
- Guidance on the assessment of the efficacy of feed additives
- Guidance on the assessment of the safety of feed additives for the consumer
- Guidance on the assessment of the safety of feed additives for the environment
- Guidance on studies concerning the safety of use of the additive for users/workers
- Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition
- 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
Following the opening plenary session where the principles and challenges of the characterisation of microorganisms used as additives or as production strains and the assessment of efficacy of feed additive were discussed, participants were divided into three small groups on specific topics:
Break-out Group 1 | Technical insights on the assessment of microorganisms used in the food chain using whole genome sequence
Break-out Group 2 | How to make a meaningful assessment of user safety for feed additives?
Break-out Group 3 | Environmental risk assessment of feed additives
The outcome of the break-out groups was presented and discussed in the final plenary session.
The meeting took place in a constructive atmosphere and marks an important step forward in reaching common understanding on risk assessment practices and enhancing dialogue among all parties.
During the meeting, it was announced that EFSA is currently preparing a document aimed at providing further guidance to applicants on how to conduct and report whole genome sequence analysis in the context of food and feed applications. This document will be subject to public consultation in the coming months. It was also announced that a tool to calculate phase I and II exposure levels and the predicted no effect concentration in sediment based on equilibrium partitioning, for environmental risk assessment of feed additives according to the provisions of the guidance will be shortly made available on the website. This tool should support applicants in the preparation of the technical dossiers and prevent calculation errors, such as mistakes in unit conversions.
A lively exchange of views regarding the current challenges for the assessment of user safety of feed additives took place between legislators, risk assessors and industry representatives, which paved the way for future work.
Additional comments and questions can be sent to: FEEDADDITIVES [at] efsa.europa.eu