91997E2125(01)

WRITTEN QUESTION E-2125/97 by Hiltrud Breyer (V) to the Commission (23 June 1997)

Subject: Novel food regulation No 258/97 - Safety tests

In the event of authorization being given for a genetically modified plant line pursuant to the varieties directive, following thorough testing of the change in its metabolites are all plants resulting from crops-breeding from this line tested for possible metabolitic change?

Supplementary answer given by Mr Fischler on behalf of the Commission (1 December 1997)

Under the current Community provisions on the common catalogue of varieties of agricultural plant species and on the marketing of vegetable seed (70/457/EEC and 70/458/EEC respectively) ((Council Directive 70/457(EEC), 29.9.1970, OJ L 225, 12.10.1970; as last amended by the Act of Accession Austria, Finland, Sweden. )) a plant variety is officially accepted for certification and marketing only if it is distinct, stable and sufficiently uniform. A variety shall be regarded as distinct if, whatever the origin, artificial or natural, of the initial variation from which it is has resulted, it is clearly distinguishable in one or more important characteristics from any other variety known in the Community.

Where Commission decisions concerning the placing on the market of genetically modified plant material, seed included, are required, these are based on the examination of the relevant dossier submitted under Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms ((Council Directive 90/220(EEC), 23.4.1990, OJ L 117, 8.5.1990. )) having taken into account all the information forwarded by the Member States and found that the information on the environmental risk contained in the dossier is sufficient to enable the Commission to take a decision on the placing on the market.

Under the plant variety legislation, there is at present no requirement for the conduct of an environmental risk assessment for genetically modified plant varieties. This task is undertaken under Directive 90/220/EEC. Under the plant variety legislation, testing for metabolic changes would only be required where this is relevant to the assessment of distinctness among varieties.

However, the Commission proposal of 1993 for the amendment of seed marketing directives ((OJ C 29, 31.1.1994. )) aims, among other objectives, to integrate the process of environmental risk assessment with the procedure of variety acceptance. After the recent opinion given by the Parliament, this proposal will be amended as follows:

(a) in the case of a genetically modified variety, an environmental risk assessment similar to that laid down in Directive 90/220/EEC will be carried out;

(b) the procedures ensuring that the environmental risk assessment referred to in (a) above is similar to that laid down in Directive 90/220/EEC shall be introduced on a proposal from the Commission in a Council regulation based on the appropriate provisions of the EC Treaty;

(c) the technical and scientific details of the implementation shall be adopted in accordance with the standing committee procedure.