Legislation

Contained use of GMOs

Implementing measures

Article 18(2) of Directive 98/81/EC amending Directive 90/219/EEC states that 'Every three years Member States shall send the Commission a summary report on their experience with this Directive the first time being on 5 June 2003' 

1. Summary Report from the Commission based on the reports of Member States concerning their experiences with Directive 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified micro-organisms for the period 1999 – 2003 and Commission staff working paper (Annex to the summary report from the Commission) 

2. Summary Report on the experience of Member States with Directive 90/219/EEC, as amended by Directive 98/81/EC, on the Contained Use of Genetically Modified Micro-organisms for the period 2003 - 2006.

3. Analysis of the applicability of the contained use legislation for clinical trials (July 2006).
   The objective of the study was to examine the extent to which clinical trials are carried out throughout the Community and the legal base used to conduct such trials in Member States.  Different approaches were evident. The legislative basis for Gene Therapy trials differs between the different Member States. Some Member States regulate such trials under the Contained Use Directive (Dir 90/219/EEC) while other member states regulate them under the deliberate release directive (Directive 98/81/EC) while yet other Member States apply their own national legislation.

4. Checklist for Contained Use Inspections developed by the European Enforcement Project
   (updated 13th October 2008)