Brussels, 05 July 2002
Proposal for a
COUNCIL DECISION
establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Full Text
EXPLANATORY MEMORANDUM
1. Directive 2001/18/EC introduces an obligation for notifiers to implement monitoring plans in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market.
2. Annex VII to the Directive describes in general terms the objective to be attained and the general principles to be followed in designing the plan referred to in Articles 13(2), 19(3) and 20 of the aforementioned Directive. The first paragraph stipulates that the Annex must be supplemented by guidance notes to be drawn up in accordance with the procedure laid down in Article 30.
3. A draft of the measures to be taken has accordingly been submitted for opinion to the committee set up under Article 30 of the Directive. This draft supplements the information provided in Annex VII and:
­ expands on the monitoring objectives;
­ expands on the general principles for monitoring;
­ provides an outline for a general framework for the development of appropriate post-marketing monitoring plans.
4. The committee has not delivered an opinion on the proposal. In such a case, Article 30 stipulates that the Commission must forthwith propose to the Council the measures to be adopted and inform the European Parliament thereof. The Council must then act by qualified majority.
5. If, by the expiry of the time limit, the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures, they shall be adopted by the Commission.
Brussels, 04.07.2002 COM(2002) 359 final