WRITTEN QUESTION E-1908/97 by Amedeo Amadeo (NI) to the Commission (4 June 1997)

Subject: Genetically modified organisms

Will the European Union establish a coherent, transparent and reliable procedure for genetically modified organisms so that it can take a lead in these developments, from which, for political, economic and commercial reasons, it cannot stand aside?

Will it, in particular, make the authorization of the production, marketing, processing and importing of GMOs subject to the following principles:

1. strengthening the EU's R& D policy concerning licencing and monitoring after the release of GMOs;

2. consultation procedure, transparency and information for all operators in the sector, from farmers to consumers, with an adequate labelling system which can be monitored to enable them to make decisions in full knowledge of the facts; in this context, the establishment of a coherent licencing, labelling and monitoring system would seem necessary for imported products as well as for products of Community origin to ensure that any problems which might arise can be resolved;

3. creation of an independent European scientific agency responsible for guaranteeing consumer safety and confidence by implementing a transparent and reliable procedure for evaluating possible risks, providing marketing authorizations for the single market and carrying out controls after the release of GMOs; it should also have the task of contributing to the creation of an international framework;

4. detailed scientific evaluation, prior to issuing marketing authorizations, based on sufficiently extensive trial data and, as an essential condition for such authorizations, continual monitoring after the release of GMOs to ensure optimum guarantees for human health and environmental protection?

Answer given by Mr Santer on behalf of the Commission (7 October 1997)

The Commission attaches great importance to the potential of genetic modification techniques and agrees that the development of these new technologies should be considered in the appropriate international context. The rapid progress of genetic modification technologies is accompanied by close regulatory attention to ensure up-to-date and coherent approval and marketing procedures as well as the highest safety standards for consumers and the environment in line with the precautionary principle.

1. Research and development relating to the safety of the release of genetically modified organisms (GMOs) has been supported under successive Community framework programmes for research and technological development. Particular attention has been given to biosafety and prenormative research in support of the Community's biotechnology regulations. Since 1986 some 175 laboratories have been supported on this topic at a cost of 25 MECU. The Commission has proposed to strengthen such research under the fifth framework programme ((COM(97) 142. )).

2. Community approval procedures for placing on the market of GMOs (in particular Directive 90/220/EEC ((OJ L 117, 8.5.1990. )) and the novel foods Regulation (EC) 258/97 ((OJ L 43, 14.2.1997. )) require a detailed scientific risk assessment and no GMOs are authorized unless they are considered, on the basis of available scientific evidence, to be safe for humans and the environment. The scientific basis for such assessment is continually up-dated according to scientific and technological progress. The Commission recognizes fully that post-release monitoring can, in some cases, contribute to a precautionary approach. Thus, in December 1996, when the Commission proposed to approve the deliberate release and marketing of the genetically modified maize (Zea Mays L.), it also decided to initiate a monitoring project for the possible development of insect resistance to the Bt-toxin.

3. The Commission launched earlier this year a new approach to scientific advice in the field of consumer health and food safety ((COM(97) 183 final. )) in order to strengthen the scientific basis of Community initiatives. In particular, this move aims at ensuring the excellence of the relevant scientific advisory committees, their independence from socio-economic and political influences as well as transparency of their working procedures and advice.

4. The novel foods Regulation, which entered into force in May 1997, establishes a framework for labelling novel foods and novel food ingredients produced from GMOs. In addition, the Commission recently introduced a labelling requirement for GMOs which will be notified for placing on the market under Directive 90/220/EEC. Labelling requirements are also under consideration by the Commission in agricultural sectors such as animal feed and seeds. In addition the Commission has decided to develop a general labelling approach which will be based upon strict science and will include mandatory labelling to indicate the presence of GMO material. It will be implemented both through existing and new legislation to be introduced as necessary.