Food safety and quality
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OECD Unique Identifier Commodity Traits Latest entry uploaded on
SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9 Corn / Maize Herbicide tolerance,Insect resistance 05/09/2019
SYN-IR6Ø4-5xMON-ØØØ21-9 Corn / Maize Coleoptera resistance,Glyphosate tolerance 16/03/2015
SYN-IR6Ø4-5xMON-ØØØ21-9 Corn / Maize Coleoptera resistance,Glyphosate tolerance 02/09/2019
SYN-Ø53Ø7-1 Corn / Maize Coleoptera resistance 29/08/2019
SYN-ØØØ98-3 Corn / Maize Coleoptera resistance,Glufosinate tolerance 09/02/2022
SYN-ØØØH2-5 Soyabean / Soybeans Glufosinate tolerance,Mesotrione tolerance 09/02/2022
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Focal Point Information

European Union
Organization/agency name (Full name):
European Union
Contact person name:
Alexandre Huchelmann
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
Fax number:
Country introduction

The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).

Regulatory framework:
My country has a regulatory framework that requires the competent authority to conduct safety assessment of GM food.
Structure for GM food safety assessment:
My country has competent authority, agency, organization, ministry, department, committee, commission or a system/mechanism that is tasked to conduct or review GM food safety assessment.
Supplemental information:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
GM food safety assessment guidelines:
My country follows the relevant Codex Guidelines or national/regional guidelines that are in line with the Codex Guidelines in conducting safety assessment of GM food.
Conduct of GM food safety assessment:
My country regularly conducts food safety assessment of GM food.
Supplemental information on the implementation:

Scientific requirements for GMO risk assessment and future perspectives (EFSA document - June 2020)

Stacked events
Regulation of stacked events:
In my country, GM food/feed that contains stacked event(s) is considered as a new product even if all single events that are stacked have already approved.
Supplemental information on the stacked events:
Production and trade
GM food/feed production:
My country produces GM food or feed for commercial and research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information on the production and trade:
LLP/AP incidents
LLP/AP incidents:
My country has faced LLP/AP situations in the last 10 years.
Supplemental information on the LLP/AP incidents:
Labelling requirement
Labelling requirement:
My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).
Supplemental information on the Labelling requirement:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment
Other relevant documents:
Country information last modified: