EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying.
Regulatory framework
- Regulation 1831/2003 on additives for use in animal nutrition
- Regulation 429/2008 on detailed rules for the implementation of Regulation EC 1831/2003
Administrative guidance
Scientific guidance
- Guidance on the identity, characterisation and conditions of use of feed additives
- Guidance on the characterisation of microorganisms used as feed additives or as production organisms
- Guidance on the assessment of the safety of feed additives for the target species
- Guidance on the assessment of the safety of feed additives for the consumer
- Guidance on the assessment of the efficacy of feed additives
- Guidance on user safety
- Guidance on the assessment of the safety of feed additives for the environment
- Guidance on the renewal of authorisation of feed additives (applicable until 26 March 2021)
- Guidance on the renewal of the authorisation of feed additives (applicable as of 27 March 2021)
- Guidance for the preparation of dossiers for the re-evaluation of certain additives already authorised under Directive 70/524/EEC
Other guidance
- Administrative guidance for the processing of applications for regulated products
- Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
