Food Law News - EU - 2001

FSA Letter, 27 July 2001

GM FOODS - Proposed Regulations

The FSA letter seeks comments on the two proposals for further legislation on genetically modified organisms (GMOs) and food and feed produced from GMOs adopted by the European Commission on 25 July.

It is likely that the Belgian Presidency will start negotiations of the proposals in early September. The FSA would therefore welcome responses by 4 September, this will also enable your views on the labelling aspects of the proposals to be considered at the 19th September meeting of the Food Standards Agency Board when they consider the feasibility and costs and benefits of further compulsory labelling.

There will be further opportunities to comment as negotiations progress. Scotland, Wales and Northern Ireland will be consulting separately on these proposals.


The European Commission's objectives for the food and feed proposal are to:

Their objectives for the proposal on traceability and labelling of GMOs and derived products are to facilitate:

Background and Options

The European novel foods regulation (258/97) requires that all GM foods are rigorously assessed for safety before they can be approved for sale. There is also a requirement to label foods containing genetically modified ingredients. These labelling rules are based on the ability to measure any differences in composition between GM and non-GM ingredients. Similar rules controlling the use of GMOs in animal feed are contained in the recently revised directive on the release of GMOs into the environment (2001/18). This directive requires the traceability and labelling of live GMOs.

Proposed regulation on GM food and feed

This proposal establishes detailed rules for the labelling of GM food and feed. The proposal also replaces the existing approval procedures for GM foods and introduces for the first time specific rules for the approval and labelling of GM animal feed.

Products containing GM material will be required to be labelled as such. The labelling of products derived from GM ingredients but containing no GM material will have to refer to the fact that the product was produced from a GMO but that no GMOs are present in the final product. Food produced with the help of enzymes from GM sources and food from animals fed GM feed will not require labelling.

The proposal also acknowledges that adventitious contamination cannot be totally avoided. The proposal allows for GMOs that have been favourably assessed by the EU Scientific Committee, but not yet fully approved, to be present in food or feed up to a maximum of 1 per cent.

The Commission's proposal places the European Food Authority (EFA), rather than individual Member States, at the centre of the approval process, but Member States will still take the final decision on applications. The EFA, once established, will be responsible for undertaking a risk assessment covering both environmental risk and the risk to human and animal health when assessing a GM food or feed ingredient. In practice, the safety assessment would be carried out on by Member States, on a rota basis, on behalf of the EFA. For GM products likely to be used as either food or feed, authorisation will be recommended for either both uses or none at all. On the basis of the opinion of the EFA, the Commission will be responsible for drafting a proposal granting or refusing authorisation. The proposal will then be put to Member States for final approval.

Proposed regulation on GM traceability and labelling

The Commission's proposal aims to elaborate on the requirements in Directive 2001/18 to trace live GMOs, and to extend them to derived products throughout the supply chain. Operators will be required to transmit information to the effect that a product contains, consists of, or is derived from GMOs. In the case of live GMOs, except those intended for direct use in food feed or processing, there is a requirement for a unique identifier, yet to be developed, relating to each specific GMO. While the proposal does not impose an obligation on countries exporting to the EU, importers will be required to obtain the appropriate documentation from their suppliers, or test every batch they import.

Issues on which views are sought

The FSA would welcome comments on all aspects of the proposed Regulations and, in particular, on:-

Proposed regulation on GM food and feed:

Proposed regulation on GM traceability and labelling

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