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On 18 October 2003, new EU Regulations on Genetically Modified Food and Feed (Regulation (EC) N° 1829/2003) and Traceability/Labelling (Regulation (EC) N° 1830/2003) were published in the Official Journal of the European Union. Members States have six months to implement both Regulations, which enter into force on 18 April 2004. The GM Food/Feed Regulation has replaced the authorisation for GM foods and food ingredients previously covered by the Novel Food Regulation (Regulation (EC) 258/97). It has also introduced, for the first time, authorisation procedures for GMOs used in animal feed which were, until now, unregulated by EU legislation. The Novel Food Regulation remains in effect for the placing on the market of 'novel foods' other than those produced from Genetically Modified Organisms. However, many products still go through the old regulation even though new laws improving the approval process come into force in April. That is the case for instance with Syngenta's Bt11 sweet corn, whose application for authorisation is currently pending. (See press release and briefing ) Many EU citizens, as well as environmental and consumer NGOs, welcome the fact that the new GM Food/Feed Regulation foresees more stringent procedures for approving GMOs in food. This is in comparison to the Novel Food Regulation, which allowed for simplified notification procedures and enabled companies to seek approval for GM foods by claiming "substantial equivalence" with conventional foods. Also welcome, are the new labelling rules of the GM Food/Feed Regulation, which 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 were previously subject to neither authorisation nor labelling, although most of the GMOs imported into the European Union actually end up as animal feed. There are, nevertheless, some negative aspects to the GM Food/Feed. This is the case with the Traceability/Labelling (Regulation (EC) N° 1830/2003) , it effectively 'legalises' contamination by setting a threshold of 0,9% for adventitious or technically unavoidable presence of GMOs, although it means that the operator has to prove that the contamination was "adventitious or unavoidable". Moreover, the new legislation allows unapproved GMOs for a period of 3 years by setting a threshold of 0.5% for the 'adventitious' or 'technically unavoidable' presence of GMOs in cases where a favourable risk evaluation has been made by the relevant Scientific Committee(s) or the European Food Safety 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 is tolerated regardless of the fact that it has not been authorised under EU legislation. This is a serious exception to the EU food safety approach, which means that decision makers (The Commission and Member States) must take the final decision. That is due to the fact that the science is sometimes unsure or contradictory In other words, the contamination thresholds will allow unauthorised GMOs to enter the food chain; furthermore these GMOs will not have to be labelled. The Food/Feed Regulation has also required the amendment of the Deliberate Release Directive 2001/18/EC which stipulated 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. This amendment therefore weakens the new Deliberate Release Directive. Including this exemption in the 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'. Rather than take pro-active steps to avoid GMO contamination, the new Regulation opens the door for contamination of the food and feed chain by unauthorised GMOs. Nevertheless, a new article concerning measures to avoid the presence of GMOs in conventional and organic crops - so-called coexistence - has also been the subject of an amendment to Directive 18/2001. This amendment puts in place a legal basis to develop and implement co-existence measures in the Members States. FoE's assessment of the GM Food/Feed Regulation
• The EU, at last, has 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" is 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 will undermine Member States' decision-making powers by giving total responsibility for risk assessment to the European Food Safety Authority (EFSA), which "may" ask appropriate agencies in EU countries to carry out food safety assessments. • The European 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 both for 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, will be considerably watered down.Countries will lose their right to take unilateral action and can 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 0.5% for unauthorised GMOs for a period of 3 years; such GMOs do not need to be labelled. • The regulation legalizes contamination with 'adventitious' or 'technically unavoidable' presence of GMOs that enter into the food chain up to a level of 0,9% without labelling. • The above exemption weakens the Deliberate Release Directive 2001/18/EC. It requires the amendment of Directive 2001/18/EC, which previously stipulated 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. Find the legislation Regulation of the European Parliament and of the Council on genetically modified food and feed of 22 September 2003 Regulation (EC) No 1829/2003 Official Journal L 268, 18/10/2003
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