Brussels, Belgium
October 17, 2002

New GMO Directive taking effect today provides more transparent and effective system for authorisation of GMOs, says European Commission

European Environment Commissioner Margot Wallström welcomed today the application of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, from 17 October. This Directive replaces a previous Directive (90/220/EEC), which has been in force for the past ten years. Commissioner Wallström said: "The European public is aware that the application of new biotechnologies in the sectors of food, health and environment is an increasingly important reality. My top priority is to protect human health and the environment. Therefore, it is our responsibility as policy makers to take strong political leadership to ensure that these technologies are appropriately regulated. With the new Directive which is operational from today we have a strong basis for a transparent and responsible way of governing the use of GMOs".

The Commission considers that it has fulfilled its commitment to create the conditions to re-start the authorisation procedure for GMOs. It is ready to play its role in managing the new procedure.

It is up to companies to decide what products they want to put on the market and to Member States to initiate the procedure for authorisation. Applicants should use the Commission's guidelines to ensure that their applications meet the new requirements of the Directive.

Commenting on the proposal for traceability and labelling, discussed by today's Council of Environment Ministers, the Commissioner said that "the regulation that Ministers are discussing today is intended to replace national rules for traceability and labelling which are required under the Directive taking effect today. An EU-wide system will ensure that the same rules apply throughout the European Union and that consumers are correctly informed about the presence of GM products in food. I hope that the Council and Parliament will adopt the Commission's proposals in the near future so that the new rules can come into force as soon as possible, and I urge Member States to give priority to solving outstanding problems".

Background

The new Directive 2001/18/EC strengthens the previous legislation, in particular with respect to a more detailed pre-market scientific evaluation of GMOs and improved transparency throughout the different stages of the authorisation procedure and subsequent handling of GMOs.

The pre-market evaluation of GMOs, including their interaction with the environment, will continue on a comprehensive scientific basis taking account of the risk assessment principles of the new Directive. This assessment will ensure that GMOs to be placed on the market are without risk to human health and the environment.
 
Mandatory post-market monitoring and general surveillance will allow the evaluation to be confirmed and potential longer-term effects to be followed.

The Commission had worked intensively in co-operation with Member States to provide the necessary guidance for risk assessment, monitoring and public information formats, as required by the new Directive. All of these measures are now in place. This guidance will enable companies and Member States to meet the objectives and requirements of the Directive.

Improved transparency will be achieved by mandatory consultation of the public during the authorisation procedure and by making information from company applications publicly available. The Commission has already developed a web page that, in accordance with the Directive, will contain information on new applications for the placing on the market of GMOs and will also provide links for the public to submit comments. The address of this web site is http://gmoinfo.jrc.it. It will be possible to ensure further transparency by the mandatory labelling and traceability of products at all stages of their placing on the market.