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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)

Other guidance