WRITTEN QUESTION E-2401/96 by Hiltrud Breyer (V) to the Commission (6 September 1996)

Subject: Decision 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants - criteria

1. What criteria have been used to ascertain whether genetically modified plants are safe for public health and the environment?

2. What are these criteria based on?

Supplementary joint answer to Written Questions E-2394/96, E-2395/96, E-2396/96, E-2397/96, E-2398/96, E-2399/96, E-2400/96, E-2401/96, E-2402/96, E-2403/96 and E-2405/96 given by Mrs Bjerregaard on behalf of the Commission (4 July 1997)

Further to its reply given on the 14 October 1996, the Commission is now in the position to provide the following information.

Written questions 2394/96 to 2397/96, 2402/96 to 2403/96 and 2405/96:

According to Article 6 (5) of Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms ((OJ L 117, 8.5.1990. )), the Commission establishes appropriate criteria and takes a decision on each application with regard to simplified procedures. The Commission decides in accordance with the procedures laid down in Article 21 of Directive 90/220/EEC which include the involvement of the Member States. The Parliament is involved in line with the code of conduct of the Commission with the Parliament. The procedures laid down in Article 21 of the Directive correspond to those identified in Council Decision 87/373/EEC ((OJ L 197, 18.7.1987. )), the so called comitology decision.

Within this framework the Commission adopted on 22 October 1993 Decision 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. )). Since France and the United Kingdom had submitted a request for the application of simplified procedures for certain releases of genetically modified plants the Commission adopted on 4 November 1994 Decision 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants ((OJ L 292, 12.11.1994. )). This Decision is in accordance with the unanimous opinion of the committee established under Article 21 of Directive 90/220/EEC. It should be noted that Decision 93/584/EC establishes criteria to form an objective and harmonized basis for decisions on the request for application of simplified procedures while Decision 94/730/EC establishes simplified procedures for certain releases.

The Commission adopted Decision 94/730/EC according to the procedure laid down in Article 21 of Directive 90/220/EEC. The procedure foresees that a regulatory committee (committee III A as identified by Council Decision 87/373/EEC) shall assist the Commission for adopting measures. Therefore, the Commission does not share the view of the Honourable Member that it has contravened Article 145 EC Treaty.

Decision 94/730/EC is addressed to Belgium, Denmark, Germany, Spain, France, Ireland, Italy, The Netherlands, Portugal and the United Kingdom. The Annex of Decision 94/730/EC is of binding character for the said Member States because the content of the Annex is part of the Decision itself and according to Article 189 EC Treaty a decision is binding to those to whom it is addressed. This Decision has been set up in accordance with Article 21 of Directive 90/220/EEC as outlined above.

The binding character of the Annex of Decision 94/730/EC is independent of any infringement proceedings that might be under way against one of these Member States. Any pending infringement proceedings have no impact on the obligations of the Member State to take measures in order to properly implement and enforce Community law.

As already outlined in the Commission's reply to written question 1651/96 by the Honourable Member ((OJ C 345, 15.11.1996. )), Article 7 of Directive 90/220/EEC states that 'where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on any aspects of the proposed deliberate release'. Neither Directive 90/220/EEC nor Decision 94/730/EC indicate when or to what extent the public is to be informed in the procedure. Therefore it is up to Member States to take a decision in this respect.

However, according to Article 19 (4) of Directive 90/220/EEC, the description of the genetically modified organism, the name and address of the notifier and the location of the release may in no case be kept confidential. And even if a notifier will not have to specify all locations of releases within a whole programme of development of work according to point 6.1 of the Annex of Decision 94/730/EC, he has to submit all additional information necessary to evaluate a specific release, which includes the location, prior to the release (point 7 of the Annex). The Commission, therefore, does not see in this respect a conflict with the implementation of Regulation No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs ((OJ L 198, 22.7.1991. )), as last amended by Council Regulation No 1935/95 ((OJ L 186, 5.8.1995. )).

Regarding the questions on the releases of cauliflower and the experience gained, the Honourable Member is invited to contact the competent authorities of Belgium. Cauliflower has been released in Belgium since 1991, and detailed information on the conditions of specific releases and new experience is best given by the competent authority directly responsible.

Written Questions 2398/96 to 2401/96:

As already outlined in the Commission reply to written question 1974/96 by the Honourable Member ((OJ C 11, 13.1.1997. )), the Annex to Decision 94/730/EC does not apply to all genetically modified plants or to all genetic modifications introduced into plants. A notifier can only make use of simplified procedures, if the conditions defined in detail in the Annex (paragraph 2 in particular) are met. Concerning the receiving ecosystem, the application of simplified procedures covered by paragraphs 1 to 5 presupposes sufficient information on the interactions of the recipient plant species in the ecosystem in which the experimental releases are to be carried out.

In the case of a simplified procedure as described in paragraphs 6.1 of the Annex to Decision 94/730/EC, the competent authority of the Member State has to evaluate any new information that is submitted in the framework of an a priori specified programme authorised under the standard procedure laid down in Directive 90/220/EEC ((OJ L 117, 8.5.1990. )). If this information is such that the original consent is no longer applicable, the competent authority has to indicate to the notifier within 15 days of receipt of the notification of the new information that he may only proceed with the intended release if a consent is granted under the standard procedure.

It is Member States which are responsible to judge whether an application for simplified procedures satisfies the requirements of Commission Decision 94/730/EC. Member States reach their decision following an examination of a submitted dossier. According to Article 9 of Directive 90/220/EEC, Member States are obliged to forward to the Commission a summary of the notifications received under part B of the Directive. Thus, the information available to the Commission does not include the detailed information requested by the Honourable Member in written question 2400/96. This information can be obtained directly from Member State authorities.

When submitting a proposal for the revision of Directive 90/220/EEC, the Commission will further clarify the conditions under which proposals for simplified procedures can be made.

The parameters used to evaluate the impact of genetically modified plants on human health and the environment are outlined in Annex II to Directive 90/220/EEC, as adapted to technical progress for the first time by Commission Directive 94/15/EC ((OJ L 103, 22.4.1994. )).