WRITTEN QUESTION P-2812/96 by Hiltrud Breyer (V) to the Commission (16 October 1996)

Subject: Safety guarantees for GMO products

With reference to Directive 90/220/EEC ((OJ L 117, 8.5.1990, p. 15.)), now that we have marketing consents for several GMO products (soya, rapeseed, chicory for example) where consent is restricted by special conditions:

1. How can the Commission guarantee that imported soya is not used for cultivation or breeding in the EU in contravention of the terms of the marketing consent?

2. How are the other restrictions to be controlled and by whom (for example rapeseed limited to non-food use only)?

3. If control is to be provided by Member States, how is this to be done and who will supervise compliance with the monitoring system?

4. Will there be compliance reports?

5. Will these be made public?

6. If there is no national or European control system, what measures are foreseen by the Commission or the Council?

7. Will the Commission support a moratorium on market releases until adequate guarantees of compliance are put in place?

8. How does the Commission policy of permitting importation of GMO products with no checks on public health or environmental well-being in the place of origin fit with their negotiating position on the contents of the proposed Biosafety protocol?

Answer given by Mrs Bjerregaard on behalf of the Commission (10 December 1996)

1., 2., 3. and 6. The conditions applied to a consent to placing on the market of a genetically modified product are controlled at Member State level by the competent authority nominated by the Member State under

Article 4 (2) of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. According to Article 13(6) Member States should take all the necessary measures to ensure that users comply with the conditions of use specified in the written consent. It therefore follows that in the case of the Monsanto genetically modified soya beans, where the consent granted is for 'handling in the environment during import, before and during storage, and before and during its processing to non-viable products', that the competent authorities should ensure that the consent conditions are met.

4. - 5. The issue of compliance reports, and whether these will be made public, is not set out in Directive 90/220/EEC and are the prerogative of Member States. However, according to Article 18 of the Directive, Member States should send to the Commission, at the end of each year a brief factual report on the control of all products placed on the market under this Directive.

So far in 1996 three consents have been issued for the placing on the market of products under Directive 90/220/EEC. These are the Plant geneticsystems swede-rape, the Monsanto soya beans and the Bejo-Zaden chicory. All consents were for specific uses and it is expected that the competent authorities will specify in their brief report to the Commission how they control the use of these products.According to Article 18(2) the Commission will report to the Parliament and the Council.

7. The Commission has started discussions with the competent authorities of Member States on the issue of controls. If there was evidence that some Member States did not carry out the appropriate controls for ensuring the correct implementation of Directive 90/220/EEC, the Commission would have to take legal action against these Member States, but would not be able to suspend authorisations of products.

8. Directive 90/220/EEC requires that before a genetically modified organism (GMO) is given consent to be placed on the market in the Community, an environmental risk assessment is completed by the manufacturer or the importer and verified by the relevant competent authority. In the case of the GMO products imported into the Community, the risk assessments have utilised data produced by the manufacturer in the place of origin for the regulatory authorities in that Member State. As such the Commission finds no conflict with its position on the proposed biosafety protocol.