Environmental Law

• Author: International Law Group

On February 16, 2001, the European Parliament and the Council of Ministers adopted a major overhaul of European requirements for genetically modified organisms (GMOs). Directive 2001/18/EC on the release into the environment of genetically modified organisms aims to control the use and release of such organisms in food, medicine, feed and seed. It repeals the previous directive on the same subject, Directive 90/220/EEC. The Member States have until October 17, 2002 to transpose the Directive into national law.

The Directive defines "Organism" as "any biological entity capable of replication or of transferring genetic material." (Article 2).

It also describes in detail what it considers "genetic modification." It includes the formation of new combinations of genetic material by inserting nucleic acid molecules and cell fusion. (See Article 2 and Annex I A, Annex I B).

The purpose of the Directive is to control such organisms better (1) through mandatory labeling, (2) by monitoring (for example through public registers where GMOs are used and released), and (3) through increased expert consultations. The Directive, however, contains an exemption for pharmaceutical research.

The Directive essentially sets up a general notification and tracking system for GMOs, similar to those for hazardous chemicals and pesticides. A party planning to use or release GMOs must first carry out an environmental risk assessment (Article 4), and then notify a designated...