91997E2180

WRITTEN QUESTION E-2180/97 by Hiltrud Breyer (V) to the Council (25 June 1997)

Subject: Novel food regulation No 258/97 - Demonstration of genetic modification

1. How will the criterion of demonstrable genetic modification be applied to seeds if the new protein(s) is/are only formed, and can be demonstrated to exist, in plants?

2. What assessment methods are to be used in future to distinguish between different batches of seeds?

Joint answer to Written Questions E-2160/97, E-2162/97, E-2164/97, E-2166/97, E-2176/97, E-2178/97, E-2180/97, E-2182/97 and E-2186/97 (28 October 1997)

As specified in Article 8(1)(a) of Regulation (EC) No 258/97 ((OJ L 43, 14.2.1997. )), an appropriate analysis should be able, if necessary, to demonstrate that certain characteristics of a novel food or food ingredient "are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics¨. It should also be noted that any arrangements for applying Article 8 will be adopted in accordance with the (Committee) procedure provided for in Article 13.

The questions are worded in such a way that it is difficult to identify the checks or monitoring to which the Honourable Member refers. The general provisions of Community legislation on the monitoring of foodstuffs are in any event applicable.

Regarding the assessments to be carried out under Articles 4 and 6 of Regulation No 258/97, the detailed arrangements, and notable the role of the Member States as regards the assessment bodies, are laid down in Article 4(3) and Article 6(2) to (4), supplemented, where Commission will publish recommendations concerning the scientifc aspects of the preparation of the initial assessment reports. These provisions are supplemented, where appropriate, by the relevant provisions of Directive 90/220/EEC ((OJ L 117, 8.5.1990. )).

Regarding methods of analysis, it will be recalled that Article 4 of Directive 93/99/EEC ((OJ L 290, 24.11.1993. )) provides that Member States shall ensure that the validation of methods of analysis used within the context of official control of foodstuffs complies whenever possible with certain criteria laid down in Directive 85/591/EEC ((OJ L 372, 31.12.1985. )) concerning the introduction of Community methods of sampling and analysis for monitoring of foodstuffs intended for human consumption.