Dossiers portant sur des OGM : règlements et documents d’orientation
La législation européenne et les documents d'orientation de l’EFSA expliquent en détail comment compléter les dossiers concernant des OGM ainsi que les données scientifiques et les autres informations qui doivent être incluses. L'EFSA actualise régulièrement ses documents d'orientation ; par conséquent, les demandeurs sont invités à vérifier qu'ils utilisent bien la dernière version avant de soumettre leur dossier.
Cadre réglementaire
Documents d'orientation administratifs
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on genetically modified plants (update 2021)
- Administrative guidance for the preparation of renewal applications on genetically modified food and feed (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
- EFSA guidance on the submission of applications for authorisation of genetically modified plants
- Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed
- 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 risk assessment of food and feed from GM plants
- Human dietary exposure assessment to newly expressed proteins in GM foods
- Explanatory note on the selection of forage material suitable for the risk assessment of GM feed of plant origin
- Guidance on allergenicity assessment of genetically modified plants
- Explanatory note on literature searching conducted in the context of GMO applications
- Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
- Explanatory note on DNA sequence similarity searches
- Explanatory note on the determination of newly expressed protein
- Environmental risk assessment of GM plants
- Guidance on the agronomic and phenotypic characterisation of genetically modified plants
- Guidance for renewal applications of genetically modified food and feed authorised under Regulation EC 1829/2003
- Guidance for the risk assessment of the presence at low level of GM plant material in imported food and feed
- Risk assessment of GM microorganisms and their products intended for food and feed use
- Risk assessment of GM plants used for non-food or non-feed purposes
- Guidance on the environmental risk assessment of genetically modified animals
- Risk assessment of food and feed from GM animals and on animal health and welfare aspects
- Guidance on Post-market environmental monitoring (PMEM) of GM plants
- Guidance on the selection of comparators
- Opinion on potential impacts on non-target organisms
- Opinion on the assessment of allergenicity of GM plants and microorganisms
- Opinion on statistical considerations including field trials
- Report on animal feeding trials
Autres documents d'orientation
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents