All installations performing activities in which pathogenic and/or genetically modified micro-organisms or organisms are involved must be notified to the regional competent authority and, according to the type of installation and the risk level of the activity, be subject to a preliminary written authorisation from this authority in the framework of the environmental permit.
The regulatory framework in the Walloon Region is the Decree of the Walloon Government of 4 July 2002 related to the contained use of genetically modified and/or pathogenic organisms (Belgian Offical Journal 21.09.2002, p. 41711). The Decree foresees that each request for an environmental permit for the above-mentioned installations shall contain a risk assessment of the contained use of GMOs and/or pathogenic organisms, according to the provisions and following the principles described in the Decree.
The risk assessment is submitted for advice by the notifier to the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health, who acts as technical expert for the Region. The advice of the SBB must be attached to the permit request.
The whole information that has to be given to notify a contained use activity represents the biosafety dossier. In order to facilitate the information and notification procedures and to limit the administrative constraints for the notifiers, the SBB has, in collaboration with the Regional competent authority, developed notification forms, a user guide and several risk assessment guidances, on the basis of the requirements of the regional Decree as well as on the experience gained with the implementation of this regulation.