GMO applications: regulations and guidance
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EU legislation and EFSA guidance documents detail how to compile GMO applications dossiers and what type of scientific data and other information must be included. EFSA regularly updates its guidance documents. Applicants are reminded to ensure they are using the latest version before applying.
Regulatory framework
- Regulation 1829/2003 on genetically modified food and feed
- Regulation 503/2013 on applications for authorisation of genetically modified food and feed
- Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
- EU register of genetically modified food and feed
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on genetically modified plants (update 16 December 2022)
- Administrative guidance for the preparation of renewal applications on genetically modified food and feed (update 16 December 2022)
- 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 19 December 2022)
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
Scientific guidance
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
Other guidance
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents