Food safety and quality
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Browse information by Country › European Union

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OECD Unique Identifier Commodity Traits Latest entry uploaded on
ACS-BNØØ3-6 Canola / Oilseed rape / Rape Seed Fertility restoration,Glufosinate tolerance 17/03/2016
ACS-BNØØ5-8 Canola / Oilseed rape / Rape Seed Glufosinate tolerance,Male sterility 18/03/2016
ACS-BNØØ5-8xACS-BNØØ3-6 Canola / Oilseed rape / Rape Seed Glufosinate tolerance 16/03/2015
ACS-BNØØ8-2 Canola / Oilseed rape / Rape Seed Glufosinate tolerance 16/03/2015
ACS-GHØØ1-3 Cotton Glufosinate tolerance 16/03/2015
ACS-GMØØ5-3 Soyabean / Soybeans Glufosinate tolerance 16/03/2015
ACS-GMØØ6-4 Soyabean / Soybeans Glufosinate tolerance 16/03/2015
ACS-ZMØØ3-2 Corn / Maize Glufosinate tolerance 26/05/2015
BCS-GHØØ2-5 Cotton Glyphosate tolerance 16/03/2015
BCS-GHØØ2-5xACS-GHØØ1-3 Cotton Glufosinate tolerance,Glyphosate tolerance 04/06/2015
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Focal Point Information

E-mail:
pablo.pindado-carrion@ec.europa.eu
Country:
European Union
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
Fax number:
Country introduction
Summary:

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).

Framework
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:
Assessment
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 does not regularly conduct food safety assessment of GM food, but has conducted at least once in the past.
Supplemental information on the implementation:
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:
28/04/2016