Food and Feed from GMOs The Long Road to Authorisation

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 GMO is based on the EU regulation on genetically modified food and feed (1829/2003).

Phase 1: Submitting an application

An application for authorising food or feed consisting of or made from a GMO must be submitted to authorities in a Member State.

Palazzo Ducale, Parma, Italy: Home of the European Food Safety Authority (EFSA). EFSA plays a central role in the approval of genetically modified food and feed. Experts on GMOs and GMO derived products: EFSA's GMO Panel, like all EFSA expert committees, consists of independent scientists from various Member States. The committee's proceedings and evaluations are made public.

The application must be accompanied by several supporting documents, including: Studies showing that the GM food is not dangerous to health or the environment Analyses showing that the GM food is substantially equivalent to conventional counterparts (e.g. by analysis of particular constituents / nutrients) Suggestions for product labelling Methods and sample material for detecting GM content An application may include a proposal for post-market monitoring. Summary of the application dossier The federal agencies forward the application along to the European Food Safety Authority (EFSA), which then notifies all of the Member States and allows them to access the application. EFSA makes the application summary available to the public. Phase 2: Safety Assessment After confirming that all required documentation is present, EFSA has six months to provide an opinion. The decision time can be extended if supplementary documentation is requested.

• The basis for the EFSA opinion is a scientific evaluation from a panel of experts on genetic engineering (the GMO Panel is a committee that examines applications to determine if a GM product remains within the range variability naturally found within its conventional counterparts.)

• If a product requires approval according to the directive on the deliberate release into the environment of genetically modified organisms (2001/18), it must be shown that all measures have been taken to prevent negative effects on human and animal health and the environment. Federal agencies of the Member States must be consulted.

• EFSA calls upon the EU reference laboratory to evaluate the detection methods provided by the applicant.

Along with a scientific safety assessment, EFSA’s official opinion  includes:

• A suggestion for product labelling

• The recommendation may include restrictions or conditions such as post-market monitoring in response to results of the safety assessment

• Detection methods confirmed by the EU reference laboratory

• Environmental monitoring plan for the GM plant

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 Decision

The 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).

• The European Commission submits its draft for a decision to the "Standing Committee on the Food Chain and Animal Health". The committee consists of representatives from all Member States and may approve or reject the Commission’s draft with a qualified majority.

• If the Standing Committee on the Food Chain does not agree with the Commission’s draft, or if a decision with qualified majority cannot be reached, the Commission must take its position to the European Council of Ministers and inform the European Parliament.

• The Council of Ministers has 90 days to approve or to reject the draft for a decision with a qualified majority. If the Council rejects the Commission’s draft, the Commission must revise its draft. If the Council approves the Commission’s draft, or if the Council cannot reach a qualified majority, the Commission’s draft for a decision comes into effect.

• Qualified majority is defined in the Treaty of Nice. Each Member State is allotted a certain number of votes according to its population (e.g. Germany 29, France 29, Czech Republic 12, Malta 3). In order to reach a qualified majority, 232 out of 321 votes are needed. Additionally, a qualified majority must represent at least 62 percent of the EU population.

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:

• The European Regulatory System for GM Plants and GM Food and Feed