GMO applications: regulations and guidance

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

Administrative guidance and support initiatives

Applicable to applications submitted until 26 March 2021	Applicable to applications submitted as of 27 March 2021
EFSA guidance on the submission of applications for authorisation of genetically modified plants	Administrative guidance for the preparation of applications on genetically modified plants (update 2021)
Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed	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	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	EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)

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

Applicable to all applications (submitted before or after 27 March 2021)

Other guidance

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents

GMO applications: regulations and guidance

Regulatory framework

Administrative guidance and support initiatives

Scientific guidance

Other guidance

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GMO applications: regulations and guidance

Regulatory framework

Administrative guidance and support initiatives

Scientific guidance

Other guidance

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