GMO applications: regulations and guidance
Last reviewed date:
EU legislation and EFSA guidance documents detail how to compile GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection 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 as of 27 March 2021
- Administrative guidance for the preparation of applications on genetically modified plants (update 23 November 2023)
- Administrative guidance for the preparation of renewal applications on genetically modified food and feed (update 23 November 2023)
- 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 December 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
Scientific guidance
Applicable to all applications (submitted before or after 27 March 2021)
GM Plants – Molecular characterisation and food/feed
Main guidance
Molecular characterisation
- 2024 Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants (replacing the 2018 version)
- 2018 Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation
Food/feed safety
- 2014 Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment
- 2017 Guidance on allergenicity assessment of genetically modified plants
- 2019 Human dietary exposure assessment to newly expressed proteins in GM foods
- 2022 Animal dietary exposure in the risk assessment of feed derived from genetically modified plants
Comparative assessment Required in law, an assessment designed to compare the safety of a genetically modified (GM) organism against its non-GM bred counterpart
- 2011 Guidance on the selection of comparators
- 2015 Guidance on the agronomic and phenotypic characterisation of genetically modified plants
- 2018 Explanatory note on the selection of forage material suitable for the risk assessment of GM feed of plant origin
GM Plants - Environmental Risk Assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation
- 2010 Environmental risk assessment of GM plants
- 2017 Explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal” gene transfer from plants to microorganisms
GM Plants - Post Market Monitoring
GM Microorganisms
Main guidance
Molecular characterisation
- 2018 Guidance on the characterisation of microorganisms used as feed additives or as production organisms
- 2024 EFSA statement on the requirements for WGS analysis of microorganisms intentionally used in the food chain
GM Animals
- 2012: Risk assessment of food and feed from GM animals and on animal health and welfare aspects
- 2013: Guidance on the environmental risk assessment of genetically modified animals
Other GM-related
- 2009: Risk assessment of GM plants used for non-food or non-feed purposes
- 2015: Guidance for renewal applications of genetically modified food and feed authorised under Regulation EC 1829/2003
- 2017: Guidance for the risk assessment of the presence at low level of GM plant material in imported food and feed
- 2019 Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market