Tina Garrity looks at the challenge of developing a legal framework for genetically modified foods

If BSE is turning out to be one of the biggest regulatory headaches the Commission has ever had to face, then genetically modified foods (GM foods) must be close behind. The development of a legal framework which meets the EU policy of allowing GM foods onto the market, while at the same time offering adequate protection to consumers, is a difficult task.

The introduction earlier this year of a new regime for the release of genetically modified organisms (GMOs) into the environment has given the Commission the opportunity to rewrite the rules governing their use in food and feedstuffs. It has published two new draft regulations, one governing GM foods and feeds in general, and one which seeks to tighten up the existing rules on labelling and to introduce a system of traceability.

AUTHORISATION PROCEDURE
Under the new regime, any company wanting to market GMOs for food use or a food containing GMOs, produced from GMOs, or containing ingredients produced from GMOs, would have to submit an application to the European Food Authority (EFA). The EFA would then conduct a risk assessment and a summary of the application dossier would be made available to the public. To qualify for authorisation, GM food would have to meet three principal criteria, where it must not:

• present a risk for human health or the environment;
• mislead the consumer; and
• differ from the food it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.

These are essentially the same criteria as listed in the 1997 novel foods regulation. The first is worded slightly differently in the 1997 regulation, which says that food should not present a danger for the consumer. The 1997 regulation would be amended by this new regulation, but not repealed since it covers a broader range of foods than just GM foods.

Among the information to be supplied to the EFA by applicants for authorisation would be a detailed description of the method of production and manufacturing, where appropriate, and information on a detection method for what is termed the "transformation event". Additionally, applicants would have to provide either a reasoned statement that the food did not give rise to ethical or religious concerns or a proposal for labelling in such cases. For foods containing or consisting of GMOs, information on the GMOs involved and a monitoring plan for the environmental effects would be required.

To the disappointment of consumer groups, some GM foods would still escape authorisation. Foods containing or produced from GMOs in which GMOs were present in a proportion no higher than 1 per cent, where that presence was adventitious (eg technically unavoidable) and where the GMOs concerned had been deemed safe by the EFA or relevant EU Scientific Committee, would be exempt from authorisation. If challenged however, food operators would need to be able to show the competent authorities that they had taken steps to avoid the presence of GMOs.

Once the EFA received an application it would, in all but the most complex cases, have six months to publish its opinion. The public would then have 30 days to comment. The EFA's opinion would then be transmitted to the Commission for a draft decision, the actual authorisation then being determined by the Council. Authorisations would be limited to ten years, being renewable for ten-year periods upon application to the EFA. A public community register of genetically modified food and feed would be established.

TRACEABILITY AND LABELLING
The concept of traceability is one of the key elements of the newly revised directive on the deliberate release of GMOs into the environment (2001/18/EC). It should assist not only quality control but also any need to withdraw products - should any unforeseen adverse effects be established, for example.

The second of the Commission's two new draft GM food regulations introduces a traceability system for GM foods and feeds. If adopted, the regulation would require operators to have in place systems and procedures to identify to whom and from whom products were made available. It would oblige them to transmit specified information concerning the identity of a product in terms of the individual GMOs it contained or was produced from. To assist in this, a unique coding system for GMOs would be developed. Member states would be required to conduct inspections and other controls to ensure compliance. They would be assisted in due course by the development of Commission technical guidance on sampling and testing.

With regard to labelling, the present system requires labelling only where there is the presence in the final product of DNA or protein resulting from genetic modification. Foods which are produced with the assistance of a GMO, eg a cheese produced with a GM enzyme, and food from animals fed on GM feed do not as a rule need to be labelled. Nor do foods containing a certain amount of adventitious contamination by GM products.

This has led to criticism from consumers. The new proposal would partially address the criticism by requiring that all foods containing or produced from GMOs, irrespective of whether trace elements remain, be labelled. This would mean that some foods which do not need to be labelled currently, such as highly refined oils of GMO origin, would now need to be labelled. However, in terms of protecting those consumers who do not wish to eat GM associated foods at all, there would still be no absolute guarantee since the exemptions outlined above for food produced with the assistance of GMOs and for food derived from GM fed animals would remain exempt.

ENFORCEABILITY
When the Food Standards Agency considered the labelling proposal at its board meeting in September, it was told that enforcement authorities had indicated that the length of the food supply chain and the lack of a suitable end-product test, in the case of GM derivatives, where the final material is indistinguishable from that produced by conventional means, would make the regulations difficult to enforce.

The Commission, in the explanatory note to its proposal, notes the fears about enforceability but points out that there are many examples of mandatory labelling being imposed despite the absence of any existing analytical methods for controlling the truthfulness of information on labels. Where no analytical methods are yet available, other enforcement methods have to be used, it says. In this case an effective traceability regime would assist the control process. This view is shared by the CIEH.

Despite the Commission's view that its proposal is both affordable and enforceable, the FSA Board did not feel able to support it. Instead, it voted to maintain the existing rules. In order to address the wishes of those consumers who do not want to eat GM foods at all, it voted for the introduction of a "GM free" labelling scheme instead. The Consumers Association has expressed its disappointment at the Board's decision. There are fears that a "GM free" scheme would lead to the development of an expensive niche market, while existing fears about the amount of GM product in all other foods would remain.

Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed. COM (2001) 425 final.

Proposal for a Regulation of the European Parliament and of the Council concerning traceability and labelling of genetically modified organisms and traceability of food and feed products from genetically modified organisms and amending Directive 2001/18/EC. COM (2001) 182 final.

Both available on the web: http://europa.eu.int/prelex/apcnet.cfm?CL=en