OBJECTIVE: to extend and clarify the scope of Directive 90/220/EEC on the deliberate release into
the environment of genetically modified organisms; to improve the administrative procedures; to
harmonize decision-making between Member States on the basis of common principles of risk
assessment; to improve the flexibility of directive 90/220/EEC while maintaining a high level of
protection for human health and the environment.
SUBSTANCE: the proposal takes into account the experience gained, the development of scientific
knowledge and the new information in the field of biotechnology since the adoption of the 1996
report on the revision of Directive 90/220/EEC. Specifically, the Commission proposes to:
- clarify the scope and definitions of Directive 90/220/EEC so as to include all direct and indirect
ecological aspects;
- introduce mandatory monitoring after the placing on the market of products linked to an
authorization granted for a fixed time period;
- confirm the possibility for the Commission to consult any committee it has created with a view to
receiving advice on the ethical implications of biotechnology;
- classify, on the basis of common criteria, experimental releases and to provide for a distinct
administrative procedure for each category of release and a multi-state procedure;
- speed up the administrative procedures through a rapid forwarding of information and to approve
a system for the placing on the market of products and to introduce simplified procedures for the
renewal of a consent;
- provide for the obligation of formally consulting a Scientific Committee in order to assist the
Commission in any matter which is likely to have an effect on human health and/or the environment
under the implementation of Part C of Directive 90/220/EEC;
- increase the transparency of the decision-making process by making available to the public the
content of the notification for the placing on the markets of GMOs as/or in a product, the assessment
reports carried out for products placed on the market and the opinion of the scientific committees;
- apply the IIIb procedure for the regulatory committee to increase the role of the Member States in
the decision-making process by giving the Council the possibility to reject the Commission decision
by a simple majority;
-detail further and broaden labelling requirements on the basis of the broad orientation for an
extended Community labelling system for GMO products.
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