BioWorld International Correspondent

BRUSSELS, Belgium - The long-awaited update to the basic EU rules on biotechnology has at last obtained agreement from the European Parliament and EU member state ministers.

The revised directive on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted last Wednesday at the Parliament's plenary session in Strasbourg, France, and on Thursday the Council Of Ministers formalized the agreement. The new rules will take effect in 18 months.

The update, proposed in February 1998, is designed to make the EU's Directive 90/220/EEC on the deliberate release into the environment of GMOs more responsive to contemporary circumstances. The formal aim is to make decision making more efficient, to harmonize risk assessment and to introduce clear labeling requirements for all GMOs. The text, the outcome of a compromise in December between the Parliament and the council, strengthens some of the EU rules, but it remains to be seen whether it will bring any more certainty into the European regulatory process for biotechnology.

GMOs used in medicines will be partially exempted from the new rules (when they are being used for research and development purposes, such as in clinical trials) as long as sector-specific rules on medicines authorization have been duly followed and provide equivalent guarantees of safety. This does not go as far as the Parliament and the pharmaceutical industry wanted initially, but the compromise is the best that could be obtained in the face of some deeply held convictions in some EU member states about the need for maximum safety.

Labeling and traceability at all stages have been made mandatory, although additional detailed regulations still need to be introduced. It must be stated clearly that "this product contains genetically modified organisms," but thresholds may be established for each product below which products containing adventitious or technically unavoidable traces of GMOs will not have to be labeled.

Other provisions of the new rule include a timetable for the gradual elimination of marker genes. Also, the public should be informed of GMOs released and - via local authorities - of the locations of field trials. And consultation of ethics committees should be a matter of course.

In parallel, the European Commission has undertaken by the end of the year to make a legislative proposal on environmental liability, covering damage resulting from GMOs. It is also planning to make proposals before July to ensure the provisions of the Cartagena Protocol on Biosafety are met, in particular by ensuring adequate controls over exports of GMOs from EU countries.

The compromise required to win agreement has not satisfied all the parties.

The European Union institutions themselves are broadly in favor. The European Commission says the new rule "will provide the foundation for a coherent, transparent and efficient regulatory framework to govern the handling of genetically modified organisms." Environment Commissioner Margot Wallström said, "The adoption of this directive represents an important first milestone toward the restoration of public and market confidence. We must show strong political leadership and explain that we have a strict, efficient and transparent system in place to deal with production and processing of GMOs."

Commissioner for Consumer Protection and Health David Byrne welcomed the development. He said the adoption of the new legislation was "an important point of departure for further legislation on the use of GMOs in food, feed and seed" through a package that is intended to "provide legal certainty for all stakeholders with regard to the authorization of such products."

David Bowe, the UK socialist Euro-MP who piloted the report through the Parliament, said, "The agreement reached can be considered as satisfactory."

EuropaBio, the European association for bioindustries, welcomed the vote as a "positive signal" that the EU will put in place a more coherent framework for the regulation and market supervision of biotechnology in Europe, and will help establish consumer confidence in the regulatory process and convince investors that there is a future for agro-biotechnology in Europe. The industry hopes the decision will lead to EU member states lifting their moratorium on new GMO authorizations, in force since 1999.

But in the Parliament, among EU member states and within nongovernmental organizations, there are plenty of dissenting voices. Belgian Green Euro-MP Paul Lannoye signaled just before the Parliament discussed the subject that he would continue to argue for tighter controls on the release into the environment of genetically modified organisms.

Even more ominously, in the Council of Ministers, France and Italy abstained from the vote. They still have deep reservations over the release of GMOs. France issued a declaration stating that the revised directive does not go far enough and that it will continue to block GMO applications. It received explicit support from Denmark, Greece, Italy and Luxembourg, and all five countries said that they would not allow any more GMO approvals until traceability and labeling of GMOs have been resolved.

One of Europe's largest environment groups, Friends of the Earth, said the new rules "will not be enough to protect consumers, farmers and the environment." It says that because of "intensive lobbying by the biotech industry," the revised directive "fails to address key issues to protect consumers and the environment." In particular, it criticized the phaseout of antibiotic-resistant marker genes, which should, it said, have been banned immediately, the lack of measures to prevent GMO pollution contaminating organic and conventional farms, and the failure to make biotechnology companies directly liable for any damage caused by GMOs.