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In July 2001, the European Commission tabled its proposals for new EU Regulations on both GM Food/Feed and Traceability/Labelling of GMOs.  The GM Food/Feed Regulation (COM(2001) 425) will replace the authorisation for GM foods and food ingredients currently covered by the Novel Food Regulation (Regulation (EC) 258/97.  It will also introduce, for the first time, authorisation procedures for GMOs used in animal feed which are currently unregulated by EU legislation.  The existing Novel Food Regulation will remain in place for the placing on the market of 'novel foods' other than those produced from genetically modified organisms.

Many EU citizens, as well as environmental and consumer NGOs, welcome the fact that the proposed GM Food/Feed Regulation would involve more stringent procedures for approving GMOs in food than the current Novel Food Regulation which allows for simplified notification procedures under which companies can seek approval for GM foods on the basis of "substantial equivalence" with conventional foods.  Also welcome are the proposed new rules for labelling of the GM Food/Feed Proposal which would extend labelling to cover all GMO derivatives such as oils and other products which currently escape labelling because DNA/foreign protein from GMOs can no longer be detected after processing.  Finally, the extension of authorisation and labelling rules to cover animal feed is a welcome and long-overdue addition to the EU's regulatory framework, since these products are subject to neither authorisation nor labelling at present, although most of the GMOs imported into the European Union actually end up as animal food.

There are, however, many negative aspects to the Commission's Proposal.  As in the case of the proposed Traceability/Labelling Regulation, it effectively 'legalises' contamination by unapproved GMOs by setting a threshold of 1% for the 'adventitious' or 'technically unavoidable' presence of GMOs.  The Commission's defends this concession on the basis that it would only be permissible if the unapproved GMOs "have been subject to a scientific risk assessment made by the relevant Scientific Committee(s) or the European Food Authority".  This means that, for example, if the EU's Scientific Committee on Plants has deemed a GMO to be safe, the presence of that GMO would be tolerated regardless of the fact that it has not been authorised under EU legislation.  In other words, the 1% contamination threshold would allow unauthorised GMOs to enter the food chain; furthermore these GMOs would not have to be labelled.

To make the above concession possible, the GM Food/Feed Proposal requires the amendment of the new Deliberate Release Directive which stipulates that thresholds for 'adventitious' or 'technically unavoidable' presence should only be allowed for authorised GMOs, and that any releases of unauthorised GMOs should be terminated.  The adoption of the proposed GM Food/Feed Regulation in its current form, therefore, would weaken the new Deliberate Release Directive which only entered into force in April 2001 and will become law in the Member States on 17^th October 2002.

Including this exemption in the proposed Regulation clearly does not ensure consumer choice (nor for that matter guarantee consumer safety) since it allows the presence on the market of GMOs which are unauthorised, not subject to traceability and are also exempt from labelling - providing that the GMO producer can demonstrate that their presence was 'adventitious' or 'technically unavoidable'.  It effectively means that 1 in 100 tomatoes, 10 out of a 1000 salmon, or 500 tons of a 50,000 ton shipment of soya could be transgenic, yet exempt from EU legislation.  The consumer, therefore, faces a lottery when, for example, buying a tomato as to whether it may be trangenic or not.

Rather than take pro-active steps to avoid GMO contamination, the Commission has unfortunately proposed legislation which would open the door for contamination of the food and feed chain by unauthorised GMOs.  Instead of initiating measures which would oblige GMO producers to ensure that their products do not pollute conventional and organic production, this proposal legalises such contamination and puts all the burden of avoiding unwanted or unauthorised GMOs on the shoulders of those who seek to avoid them.

FoE's assessment of the GM Food/Feed proposal
On the positive side:

• the EU would, at last, have an authorisation procedure and labelling rules for GMOs used in animal feed;

• the simplified procedure for placing GM food on the market under the concept of "substantial equivalence" would be discontinued;

• all GMO-derived foods should be labelled, regardless of whether processing and heat treatment make the detection of foreign DNA/protein in the finished product impossible.

On the negative side:

• animal products such as meat, milk and eggs from animals which have been fed on GMOs are not subject to labelling despite the fact that they have been produced with GMOs, although consumer organisations have called for such products to be labelled, and a traceability system would make labelling possible;

• the authorisation procedures set out in the Proposal would undermine Member States' decision-making powers by giving total responsibility for risk assessment to the future European Food Safety Authority (EFSA) which "may" ask appropriate agencies in EU countries to carry out food safety assessments;

• the Commission splits the responsibility for risk assessment and risk management between the EFSA and the Member States respectively;

• it would be possible for companies to file a single application for both placing a GMO on the market and for authorisation of that GMO as food and/or feed, thus by-passing the Deliberate Release Directive 2001/18/EC;

• emergency measures which currently exist under the Deliberate Release Directive for EU Member States to take action should they consider that a particular GMO poses a risk to the environment or human health would be considerably watered down - countries would lose their right to take unilateral action and could only "inform" the EFSA and the European Commission about their concerns.

• exemptions from the Regulation are made for the 'adventitious' or 'technically unavoidable' presence of GMOs up to a threshold of 1%; such GMOs need neither be authorised nor labelled;

• The above exemption requires the amendment of the new Deliberate Release Directive 2001/18/EC which stipulates that thresholds for 'adventitious' or 'technically unavoidable' presence should only be allowed for authorised GMOs, and that any releases of unauthorised GMOs should be terminated.

FoE's Position Paper on the proposed GM Food/Feed Regulation will appear here soon.

Find the legislation

Proposal for a Regulation of the European Parliament and of the Council on genetically modified food and feed
/* COM/2001/0425 final - COD 2001/0173 */
Official Journal C 304 E , 30/10/2001 P. 0221 - 0240 http://europa.eu.int/comm/food/fs/gmo/gmo_legi_authorise_en.html