The Commission presents this report which specifically concerns Directive 2001/18/EC and the deliberate release of GMOs, although the wider legislative framework is also considered.
It should be noted that this first report relates only to 15 Member States given that the reporting period in question ended prior to the date of entry for accession countries (1 May 2004). Subsequent three-year reports will, however, include these additional Member States.
The Commission also includes a specific report on the operation of part B and part C of the Directive which includes issues such as an assessment of its implications; the feasibility of various options to improve further the consistency and efficiency of this framework, including a centralised Community authorisation procedure and the arrangements for the final decision making by the Commission; the socioeconomic implications of deliberate releases and placing on the market of GMOs.
Given that the Directive became fully applicable as of 17 October 2002, there is still relatively little experience of its implementation. The lack of transposition by a number of Member States also hinders implementation. Nevertheless, there is general agreement that the Directive, together with the recent Regulations on GM Food and Feed and Traceability and Labelling, help to increase confidence in the legislative framework and to increase the predictability of the decision-making process.
Currently, most concerns relate to the need for guidance in interpreting elements of the Directive such as post-market monitoring, the phasing out of antibiotic resistance marker genes which may have adverse effects on human health and the environment, and non-plant GMOs. In addition, guidance is required on the interaction of the various pieces of legislation.
Lastly, the Commission and Member States are already working on guidance for post-market monitoring and antibiotic resistance marker genes.