BELGIAN BIOSAFETY SERVER : Council Decision 2001/204/EC
[Contents] [decision] [Annex]

EXPLANATORY MEMORANDUM

1. Directive 98/81/EC, amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms, was adopted on 26 October 1998.

2. The Directive provides the regulatory framework for activities with genetically modified micro-organisms (GMMs) under appropriate conditions of containment used to limit their contact with the general population and the environment.

3. Article 3 of Directive 90/219/EEC provides that types of GMMs may be excluded from the Directive if criteria establishing their safety to human health and the environment are met.

4. This exclusion only applies when the GMM is used under conditions of contained use as defined in Article 2(c) of the Directive.

5. The criteria are to be listed in Annex II, Part B, which is to be adopted before 5 December 2000, by the Council acting by a qualified majority on a proposal from the Commission on the basis of Article 20a of the Directive.

6. These criteria include both general and specific criteria, which have been considered in conjunction with the competent authorities, established under the Directive, of Member States and through consultation of the Scientific Committee(s).

7. In order to facilitate the application of these criteria the Commission should be able to adopt detailed guidance notes in accordance with the procedure set out in Article 21 of the Directive.


BELGIAN BIOSAFETY SERVER : Council Decision 2001/204/EC
[Contents] [decision] [Annex]