Legislation

Deliberate release into the environment of genetically modified organisms

Basic legislation: Directive 2001/18/EC

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms is the basic legal act for the authorisation of GMOs for marketing throughout the EU, including commercial cultivation. It repealed and replaced Directive 90/220/EEC, aiming at strengthening the control of risks from the deliberate release of GMOs into the environment. The key features of the Directive include a harmonised approach to risk assessment, post-market monitoring, traceability and labelling, consultation with and information to the public, predictability and transparency of decision-making and time-limited consents.

Explanatory Memorandum to Directive 2001/18/EC

Directive 2001/18/EC was amended by Directive 2008/27/EC as regards the implementing powers conferred on the Commission.

Working group on New Techniques

The Commission set up a specialised Working Group in December 2008 to consider new biotechnological techniques being applied in plant breeding and/or the modification of other organisms. Member States have each appointed scientific experts to participate in the work of the Group, which is examining a range of new techniques to assess whether they should be considered to lead to GMOs or GMMs as defined under Directive 2001/18/EC or Directive 90/219/EEC, respectively.

The Working Group is expected to finalise its work in the fall of 2009. The final results will be examined by the Commission in parallel with the results of the technical evaluation of the regulatory framework of the cultivation of GMOs, which are expected during the first quarter of 2010. The findings of the Working Group may be also referred to EFSA for their opinion.

This Working Group is established in line with the provisions of Article 31(1) of Directive 2001/18/EC, which stipulates that Member States and the Commission shall meet regularly and exchange information on the experience acquired with regard to the prevention of risks related to the release and placing on the market of GMOs.

Terms of Reference