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Oct 13, 2013 | | | 8:41 pm |
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Food and feed made from genetically modified organisms (GMOs) can only be allowed on the market once they have received authorisation. The authorisation process is carried out by the EU, and the resulting decision applies to all EU Member States. The process for authorising a new Phase 1: Submitting an applicationAn application for authorising food or feed consisting of or made from a GMO must be submitted to authorities in a Member State.
Along with a scientific safety assessment, EFSA’s official opinion includes:
EFSA submits its opinion to the European Commission and to the Member States. The opinion is made available to the public, except for certain aspects that could compromise the applicant’s economic interests by disclosing techniques and sensitive information to competitors. Phase 3: Final DecisionThe European Commission has three months after receiving EFSA’s opinion to produce a draft of a decision. If the European Commission’s draft for a decision is different from EFSA’s opnion, written justification is required. The decision process is delineated in the Treaty on European Union and in other legal documents. This process applies not only to GMO regulation, it is the general process used in all legislative decision-making (regulatory proceeding according to article 5 of resolution 1999/468/EG).
All authorisations are valid for ten years. Authorised GM foods are entered into a public register. Approval procedures for genetically modified plants (according to the directive on deliberate release into the environment of genetically modified organisms) The same procedures apply to applications needing authorisation under the directive on the deliberate release into the environment of genetically modified organisms (2001/18). The basis for this authorisation is an environmental impact assessment. The applicant can decide either to seek authorisation under the directives on deliberate release into the environment of genetically modified organisms or only under the regulation for genetically modified food and feed (1829/2003). If the applicant wishes to receive authorisation for a GMO both for release and for food and feed, the application is submitted to national authorities, which then carry out their own safety assessment. If other Member States or the European Commission voice objections, the application is passed along to the Commission for a new safety assessment. The process then continues according to the GM food and feed procedures described above. It is possible to submit both applications – for food and feed and for deliberate release - for one, integrated safety assessment. See also in GMO-Compass:
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EU Regulation on GM Food and Feed
Food Safety: Human Health
Further Information
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