WRITTEN QUESTION P-1974/96 by Hiltrud Breyer (V) to the Commission (12 July 1996)

Subject: Simplified procedures

1. On the basis of what scientific data on the safety of experimental releases of genetically modified plants was the simplified procedure authorized?

2. Will the Commission make this information available?

3. How is it that the 15 day time limit in points 7.2 and 7.3 of the Annex to Decision 94/730/EC ((OJ L 292, 12.11.1994, p. 31. )) is not a time limit for the authorities, after which release can no longer be prohibited, but a waiting period for the person making the release?

4. On the basis of what decisions of the European Curt of Justice does European law take precedence over national regulations in respect of Commission decisions, for example Decision 94/730/EC, even where the national laws implementing a decision require the approval of a constitutional body such as the German Bundesrat but that approval has not yet been given?

5. Under Article 7 of 90/220/EEC ((OJ L 117, 8.5.1990, p. 15. )) are the Member States at liberty to require that the public are consulted even in the case of 93/584/EEC ((OJ L 279, 12.11.1993. )) and 94/730/EC procedures?

Answer given by Mrs Bjerregaard on behalf of the Commission (5 September 1996)

1. - 2. According to Commission Decisions 93/584/EEC establishing the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants ((OJ L 279, 12.11.1993. )) and 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants ((OJ L 292, 12.11.1994. )), experimental releases under Council Directive 90/220/EEC ((OJ L 117, 8.5.1990. )) can be notified by simplified procedures if the recipient is a plant of well-known taxonomic status and biology and if there are scientific data from experimental releases of the same species showing that the genetically modified plants are safe for human health and the environment. The data may come not only from experience of the competent authority examining the release but also from international experience in similar ecosystems.

These scientific data on the impact on human health and the environment from experimental releases are published regularly in scientific journals or proceedings of national and international symposia and are therefore publically available. For more detailed information on specific releases and new experience, the competent authorities of the Member States could be contacted.

3. The question concerns the simplified procedure foreseen for certain genetically modified plants in the case of a whole programme of development work specified a priori. In such a case, as outlined in No 6 of the Annex to Commission Decision 94/730/EC, the simplification concerns the follow-up to any additional information provided by the notifier. According to point No 7.2 of the Annex the notifier can proceed with the release 15 days after the date of receipt by the authority of that additional information. According to point No 7.3 of the Annex to Decision 94/730/EEC, the authority, in specific cases, may indicate to the notifier within the same period that he may only proceed with the intended release if a consent is granted under the standard procedure laid down in the Directive 90/220/EEC. Therefore the period of 15 days concerns both parties, the notifier and the competent authority. It should be underlined in this context that even after the expiry of the period, the competent authority may in specific cases suspend or terminate the release, as foreseen in Article 6 paragraph 6 of Directive 90/220/EEC.

4. Community law prevails over national law. This rule has been stated by the Court of Justice continuously in its judgments ((Case 6/64, ECR 585. )) and applies irrespective of the nature of the Community provision. It therefore applies also to decisions such as Commission Decision 94/730/EC according to Article 189 paragraph 4 of the EC Treaty.

5. The possibility for a Member State to provide, according to Article 7 of Directive 90/220/EEC, that groups or the public shall be consulted on any aspect of the proposed deliberate release is not affected by the Decisions mentioned by the Honourable Member.