Luxembourg, 17 April 2002
I EXECUTIVE SUMMARY
1. The EEA EFTA States welcome the proposal for the regulation on genetically modified (GM) food and feed. This represents a major initiative designed to protect human and animal health, as well as environment and consumer interests. The proposed approach to include GM food and feed in the entire food chain from farm to fork is supported. Furthermore, the EEA EFTA States welcome the fact that the proposal requires labelling of all GM foods and feed, irrespective of whether there is DNA, or protein of GM origin, in the final products. The EEA EFTA States also agree that authorisations should be time limited and that the simplified procedure for marketing of GM products of "substantial equivalence" will be abandoned. The EEA EFTA States note with satisfaction that the proposal includes increased transparency concerning the authorisations procedure and increased obligations for operators to provide methods for sampling and detection and plans for post-market monitoring.
2. Following the presentation of the legislative package on GMOs in July 2001, EFTA presented a Fact Sheet to the Commission on 10 July 2001 explaining its position on the Novel Food and GMO issue. The new proposed legislation is more in line with the opinion of the EEA EFTA States, especially with regard to the labelling provisions and the authorisation procedure, and would thus be very helpful in the incorporation and implementation process. In addition to the above, the EEA EFTA States also want to present some views on the different chapters of the proposal. [()] (Text included in summary).
III COMMENTS TO SPECIFIC ASPECTS OF THE REGULATION
3. It is understood that with regard to food in general, all types of GM components are included - ingredients, additives, flavourings, extraction solvents, processing aids etc. The only exceptions are described in the explanatory memorandum as products "produced with GMO", which may be some processing aids, enzymes of different categories, animal products from animals fed by GM feed, etc.
The EEA EFTA States are of the opinion that these exceptions should be described and clearly spelt out in the Regulation itself and not only in the explanatory memorandum. Furthermore, the question is raised as to whether the proposed legal text also includes a wider range of provisions than those directly related to food as such. Article 3(1)(a) includes GMOs for food use, but is not included in the labelling section. The Regulation seems to be somewhat unclear in this field, but it is understood that all raw material (i.e. bulk) intended for food production shall be authorised, but not labelled. The Commission proposal for a regulation on traceability and labelling (COM (2001) 182 final) also includes GMOs for food use and the two proposals are closely connected. The objective to improve the coherence between the different EC regulations and to cover the whole food chain is supported, but the EEA EFTA States are of the opinion that there is a lack of clarity concerning the aspects of labelling and traceability which should be looked into further.
3.2 Adventitious or technical unavoidable presence of genetically modified material
3. Articles 5 and 18 state that products containing adventitious, or technically unavoidable GM food and feed material in a proportion not higher than 1%, or lower thresholds, may be placed on the market provided that "the relevant Scientific Committee(s)" or the European Food Safety Authority (EFSA) have performed scientific risk assessment of the material and concluded that there is no risk for human health, animal health, or the environment. It is understood that the term "the relevant Scientific Committee(s)" is meant to be the relevant committee appointed according to the EU regulation.
4. The EEA EFTA States are of the opinion that there is a need to search for practical solutions concerning the presence of very small amounts of GM material and that extended discussions are necessary, in order to be able to keep the threshold proposed as low as possible. Nevertheless, a threshold of 1% could, in certain instances, be too high, especially for living GMOs.
5. Furthermore, there is also the quesiton of whether the Regulation operates with different levels of accepted GM material. Articles 5 and 18 only include material which is risk assessed by the relevant Scientific Committees, but the authorisation procedure includes other aspects than risk, such as nutrition, ethics, religion and labelling, as well as the possibility for interested parties to make comments. If reasoned objections from Member States lead to a negative decision for authorisation of the relevant GM material, the acceptance of the adventitious material should be reconsidered. This possibility should be dealt with in the Regulation. An extensive use of 1% risk assessed material while the authorisation process is pending and also without labelling, could cause problems with regard to consumer confidence in foodstuffs in general. The EEA EFTA States also want to point to the fact that while the above articles mention a specific 1% threshold with regard to authorisation, no threshold is indicated concerning the labelling demands. The need for better coherence between the authorisation and labelling demands to increase the applicability of the regulation should be looked into further, both in terms of the text of the two articles, as well as the preamble.