Survey on the implementation of Directive 2009/41/EC

Within Europe Directive 2009/41/EC is adopted for the contained use of genetically modified micro-organisms (GMMs). The Member States implemented this Directive in their own way in their national gmm-regulations. Until now, no general overview was available on these different regulatory systems. A comparison of the regulatory systems in the EU may be of help to avoid unnecessary administrative burden.

To gain insight in the way Member States have implemented the Directive in their national regulatory systems, COGEM commissioned Ameco and Horizons to conduct a survey on this topic. The survey was conducted in 11 EU Member States, with the aim to identify commonalities and differences in the implementation of the Directive in terms of: procedures; administration; substantive requirements; and enforcement. The survey comprised desk research, questionnaires, telephone interviews, followed by face-to-face interviews in 8 Member States with representatives of Competent Authorities (CA), inspectorates, advisory bodies, Internal Biosafety Committees and applicants.