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Regulatory Framework
LMOs destined for contained use
(Last revised: 5 May, 2010 )
(Further information: bbch@wiv-isp.be)

NB: Most of the links below refers to the Belgian Biosafety Server

The Belgian legislation on the contained use of LMOs (living modified organisms) - referred to in Belgium as GMOs (genetically modified organisms) - is based on the implementation or the enforcement of European Directive 98/81/EC (revising Directive 90/219/EEC), and subsidiary EC Decisions 2000/608/EC and 2001/204/EC. These Community measures ask for Member States to regulate the contained use of genetically modified micro-organisms in order to minimise their potential negative effects on human health and the environment. Although the EU regulatory framework only covers genetically modified micro-organisms, the scope of the Belgian regional legislations has been extended to genetically modified organisms. Moreover, considering that the safety of manipulations involving GMMs and GMOs is assessed taking into account the characteristics of the recipient and donor (micro-)organisms and in particular their pathogenicity for humans, animals or plants, pathogenic organisms have also been included into the scope of the regional legislations.

The contained use of LMOs (GMOs) is regulated in Belgium at the regional level. The three Regions (Flanders, Wallonia and Brussels-Capital) have implemented the above-mentioned EU legislation as part of their Environmental laws for classified installations. In such a general context, biosafety is just one of the safety issues covered by the environmental permit.
All activities in laboratories, animal houses, greenhouses, hospital rooms and large-scale production facilities involving living modified organisms (genetically modified organisms) are subject to a preliminary written authorisation from the relevant regional competent authorities on the basis of a specific notification and decision procedure. During the procedure, the risk assessment is submitted for advice to the Division of Biosafety and Biotechnology (SBB), who acts as technical expert for the Regions.

For more information about the procedural aspects, visit the relevant chapter of the Belgian Biosafety Server.


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