Brussels 16/12/2003

During the stakeholder meeting of 1st December 2003, interested parties were invited to submit written comments on the draft Recommendation implementing Articles 5, 8, 17 and 20 of Regulation 1829/2003/EC. EURO COOP, the European Community of Consumer Co-operatives, understands that the draft proposal is currently being discussed with other Directorate-Generals and the Member States, and that it will be submitted to vote at the Standing Committee on the Food Chain and Animal Health in February 2004. We would like to take this opportunity to thank you for consulting the stakeholders on this important piece of legislation and offer the following initial comments as a contribution to the debate.

EURO COOP wishes to express its support to the draft Recommendation. Consumer co-operatives strongly support the new EU Regulation on GM feed and food as they believe that it is an important step towards better consumer safety and consumer choice. Now that the new Regulation 1829/2003/EC is in force and will be fully applicable rather soon (on 18.04.04), EURO COOP believes that strict, clear, and coherent implementing measures are crucial to ensure efficient and harmonised consumer protection. Such measures are also key to facilitating enforcement at national and European levels.

With this first general comment in mind, EURO COOP believes that the choice of a Recommendation as a legal instrument is not the most appropriate one. Recommendations are not legally binding and do not have any compulsory power. We understand that your services consider that a Recommendation would allow flexibility where needed. However, given the importance to consumer safety of the requirements concerning the preparation and presentation of applications EURO COOP believes that this piece of legislation should contain key minimum compulsory requirements without derogations. These minimum requirements will be completed by EFSA and Joint Reseach Centre Guidelines. Flexibility can be achieved through other binding instruments at the disposal of the European Commission.

In terms of timing, EURO COOP believes that it is crucial that EFSA adopts its detailed guidance for GM food and feed applications before 18 April 2004, as required by Article 5 (8) and 17 (8) of Regulation 1829/2003. We understand that the EFSA Panel on Genetically Modified Organisms discussed this matter on 25 November and 11 December 2003, and we would urge the Commission to continue its close collaboration with EFSA on this matter.

It is equally important that the Joint Research Centre adopts its method acceptance criteria and method performance requirements shortly. Annex III gives the impression that these documents are already available, although this is not the case ("[they] have been compiled"…. "the method criteria (…) described under I (B) will be taken into account"). We believe that they should be publicly available on the Internet.

Turning to the Annexes themselves, EURO COOP is concerned that Annex I does not go as far the Regulation itself concerning the application for authorisations. Three key requirements contained in Article 5 of Regulation 1829/2003/EC have not been included into Annex I, although they are all significant to ensure consumer safety and environmental protection.

We would therefore suggest the insertion of the following requirements in Annex I:

1. "Should submit a copy of studies, including, where available, independent, peer-reviewed studies which have been carried out and any other material which is available to demonstrate that the food complies with the criteria referred to in Article 4 (1) of Regulation 1829/2003/EC" (Article 5 (3) (e) of Regulation 1829/2003/EC);
2. "Should, where appropriate, submit a proposal for post-marketing monitoring regarding use of the food for human consumption" (Article 5 (3) (k) of Regulation 1829/2003/EC);
3. "Should submit the complete technical dossier required by Annexes II and IV of Directive 2001/18/EC and conclusions about the risk assessment required by Annex II of Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under Part C of Directive 2001/18/EC, a copy of the authorisation decision" (see exact wording of Article 5 (5) (b) of Regulation 1829/2003/EC).

The issue of confidentiality was also discussed at the stakeholder meeting of 1st December. EURO COOP considers that transparency is key to regaining consumer confidence and understand that Article 30 of Regulation 1829/2003/EC will apply. We believe that the Article 30 (1) stating that "verifiable justification must be given (to justify that the information is confidential)" should be further explained in the proposed Recommendation. Explanation as to who will decide in case of conflicting opinions regarding the qualification as "confidential" should also be provided. We understand from the stakeholder meeting that the Commission would decide in such cases, and we would agree with that suggestion.

Regarding Annexes III and IV, EURO COOP believes that the development and validation of methods for detecting and quantifying GMOs in feed and food are key. They will also be essential to the implementation and enforcement of Regulation 1830/EC concerning the traceability and labelling of GMOs. While EURO COOP has not specific technical comments to make on Annexes III and IV, consumer co-operatives believe that the data received by the Joint Research Centre should be made accessible to the public.

Our final comment relates to the implementation of Article 47 of Regulation 1829/2003/EC, in particular the demonstration of "adventitious presence" of GM material in feed or food (Article 47 (1) (a)). EURO COOP believes that existing traceability and segregation of GM and non-GM storage are very important to prevent cross-contamination and that these systems will be crucial to operators to prove that the contamination was accidental or "adventitious". For example, consumer co-operatives have developed Identity Preservation systems to offer consumers an alternative to GM foodstuffs. The British EURO COOP member, the Co-operative Group, applies the Food and Drink Federation and British Retail Consortium standards for identity preserved supplies. These standards consist of agreed best practices to be applied all along the food chain, from seed supply to the use of end ingredients in the manufacture of final food products .

As mentioned in our comments on co-existence of May 2003 , another aspect that would need to be carefully controlled would be deliberate blending or mislabelling of a GM crop as non-GM. There would need to be appropriate safeguards and penalties to prevent this. EURO COOP believes that effective systems of traceability are also of paramount importance in identifying and preventing cross-contamination. Structured systems such as Hazard Analysis Critical Control Point (HACCP) would need to be employed to identify critical points for cross-contamination, enabling appropriate corrective measures/monitoring procedures and associated documentation to be put in place. There would need to be effective protocols for testing any traceability systems to verify its efficacy.

Finally, EURO COOP insists that segregation is a key tool, but finds that it would be difficult to achieve in the absence of EU and national legislation on co-existence. Some Member States have already taken the initiative to develop national legislation on co-existence (for example Denmark, the Netherlands). Such legal measures will play a key role in resolving problems of liability. Good agricultural practices and guidelines are useful in ensuring well-implement co-existence measures. However, as they are not legally-binding, they impose no legal requirements on producers who do not currently follow them.