Brussels, Belgium
April 10, 2003

The European Commission has formally requested that France, Luxembourg, Belgium, Netherlands, Germany, Italy, Ireland, Greece, Spain, Portugal, Austria and Finland adopt and notify national legislation implementing EU law on the deliberate release of genetically modified organisms (GMOs) into the environment. The twelve Member States cited have failed to meet an agreed deadline of 17 October 2002 for the adoption and notification of such legislation. This legislation repeals earlier legislation and was adopted to help better ensure a safe, step-by-step approach to release of GMOs into the environment. The requests sent to the twelve Member States take the form of Reasoned Opinions, the second stage of the infringement procedure as laid down in Article 226 of the EC Treaty.

Commenting on the decisions, Environment Commissioner Margot Wallström said: "I urge Member States to quickly bring their national legislation into line with the new agreed EU framework for regulating the release of GMOs into the environment."

As of 17 October 2002, a new Directive revising the original framework for regulating the release of GMOs in the European Union came into force(1). The original regulatory framework, which was established by the 1990 Directive(2), was established in response to concerns that the release of GMOs might lead to irreversible damage to the environment. A 1996 review identified several aspects of the original framework that needed clarification and improvement. As a result, Directive 90/220/EEC was revised and replaced by Directive 2001/18/EC. The revised Directive maintains the structure of the old directive, but improves the strictness and transparency of the provisions, notably creating a more effective and efficient authorisation procedure. In particular, it introduces:

• Principles governing environmental risk assessment
• Mandatory post-market monitoring, including monitoring of possible long-term effects on the environment
• A requirement to communicate information to the public
• A requirement for Member States to ensure labelling and traceability at all stages of marketing
• A requirement that initial approvals of GMOs be limited to a maximum of ten years
• Obligatory consultation of the Scientific Committee(s)
• An obligation to consult the European Parliament on decisions to authorise the release of GMOs
• The possibility, under the new comitology procedure, for Council of Ministers to adopt or reject a Commission Proposal for authorisation of a GMO by qualified majority

The authorisation procedure for the marketing of GMOs under Directive 2001/18/EC is, as before, conducted on a case-by-case basis. When a Member States' competent authority receives an application, it must immediately send the Commission and other Member States a summary of the notification. The Commission must then immediately make the summary available to the public for comments.

France, Luxembourg, Belgium, Netherlands, Germany, Italy, Ireland, Greece, Spain, Portugal, Austria and Finland have all missed the 17 October 2002 deadline for transposing the Directive into national law and have not delivered what they agreed to by adopting the new legislation.

Background

Legal Process

Article 226 of the Treaty gives the Commission powers to take legal action against a Member State that is not respecting its obligations.

If the Commission considers that there may be an infringement of Community law that warrants the opening of an infringement procedure, it addresses a "Letter of Formal Notice" to the Member State concerned, requesting it to submit its observations by a specified date, usually two months.

In the light of the reply or absence of a reply from the Member State concerned, the Commission may decide to address a "Reasoned Opinion" (or final written warning) to the Member State. This clearly and definitively sets out the reasons why it considers there to have been an infringement of Community law and calls upon the Member State to comply within a specified period, normally two months.

If the Member State fails to comply with the Reasoned Opinion, the Commission may decide to bring the case before the European Court of Justice.

For current statistics on infringements in general, please visit the following web-site:
http://europa.eu.int/comm/secretariat_general/sgb/droit_com/index_en.htm#infractions

(1) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

(2) Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms