Contained use of GMOs and/or pathogenic organisms: Notification procedures

Procedural requirements (including contact points and forms) for the notification of a contained use activity:

"Contained use" refers in Belgium to activities involving genetically modified and/or pathogenic micro-organisms, genetically modified plants or genetically modified animals in a "closed environment" such as laboratories, animal units, greenhouses, production units and hospital rooms. They mainly include diagnostics, R&D and large-scale activities. 

Some examples of the application of the legislation in the case of contained use of pathogenic micro-organisms (non-GM) can be found here in French and Dutch.
The use of GMOs in clinical trials as part of gene therapy or in veterinary trials may in some cases also be considered "contained use"​. In that case however, specific notification procedures apply (see relevant section on this website).

Contained use activities are regulated at regional level as a part of the environmental laws for classified installations.

=> Belgian regulatory framework​ for the contained use of genetically modified and/or pathogenic organisms​

The contained use regional legislations are based on the implementation of the European Directive 2009/41/EC (this Directive repeals Directive 90/219/EEC and its successive amendments Directive 94/51/EC, Directive 98/81/EC and Decision 2001/204/EC).

Any contained use activity is subject to a preliminary written authorisation from the relevant regional competent authority(ies) on the basis of a specific notification and decision procedure. During the procedure, the risk assessment is submitted for advice to the Biosafety and Biotechnology Unit (SBB), who acts as technical expert for the Regions.

    Risk assessment tools: The SBB provides on this website several tools (Guidelines, recommendations, technical notes, Weblinks) to help people involved in contained use activities to assess the health and environmental risks of their activities and implement the appropriate risk management measures.

    Emergency and intervention plans​: The contained use legislation foresees specific measures for preventing and managing accidents, in particular the establishment of emergency plans