Additifs pour l'alimentation animale : règlements et documents d'orientation
La législation européenne et les documents d'orientation de l’EFSA expliquent en détail comment compléter les dossiers ainsi que les informations et les études requises aux fins de l'évaluation. Les documents d’orientation de l'EFSA sont régulièrement mis à jour ; les pétitionnaires sont donc invités à vérifier qu'ils utilisent la dernière version avant de soumettre leur dossier.
Cadre réglementaire
- Regulation 1831/2003 on additives for use in animal nutrition
- Regulation 429/2008 on detailed rules for the implementation of Regulation EC 1831/2003
Documents d'orientation administratifs
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on additives for use in animal nutrition (update 2021)
- Administrative guidance for the processing of applications for regulated products (update 2021)
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update January 2024)
Applicable to applications submitted until 26 March 2021
- Administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition
- Administrative guidance for the processing of applications for regulated products
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products
Documents d'orientation scientifiques
Applicable to all applications (submitted before or after 27 March 2021)
- 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
- Trial Protocol Data Sheet – Terrestrial Animals
- Trial Protocol Data Sheet – Aquatic Animals
- Feed Additives maximum safe Concentration in feed for Target Species calculator (FACTS) calculator
- General approach for the assessment of botanical preparations containing genotoxic and/or carcinogenic compounds
- 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
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Related topic
Voir aussi
- Feed additives applications: frequently asked questions
- Feed additives applications: Tools
- Toolkit
- Authorisation: European Commission’s Directorate-General for Health and Food Safety
- Samples and analytical methods: European Union Reference Laboratory
- Video: Update of sectoral and administrative Guidance Documents to address the Transparency Regulat…