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BELGIAN BIOSAFETY SERVER

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Contained use of GMOs and pathogens
(Last revised: December 15, 2009 )

Contained use is, any operation in which micro-organisms are genetically modified or in which genetically modified and/or pathogenic micro-organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers, or a combination of physical barriers together with chemical and/or biological barriers, are used to limit their contact with the general population and the environment.

Europe	Belgium
Regulatory Framework	Regulatory texts, Contacts, Procedures, Notification Forms	Emergency Plans
EU legislation on contained use: historical background Directive 2009/41/EC: Full text Directive 2009/41/EC: Main elements Other EU legislation relating to contained use Transposition of the contained use legislation in Belgium: historical background	Flemish Region Walloon Region Brussels-Capital Region	Emergency and intervention plans concerning genetically modified micro-organisms (Ministerial Circular from Internal Affairs, 4 December 2005) In French - In Dutch
Tools for Risk Assessment and Risk Management with Guidelines, Recommendations, Technical notes , Weblinks
Summary reports on the experience of Belgium with Directive 90/219/EEC as amended by Directive 98/81/EC covering periods 1992 - 1995, 1996 - 1998, 1999 - 2002 and 2003 - 2006
High Level Containment Facilities in Belgium, Reporting period 1995-2008 (PDF, 2.2 MB) available in French - in Dutch
Laboratory-acquired infections: short introduction, references and recently reported laboratory-acquired infections Recently reported Laboratory-Acquired Infections or related studies
WHO resolution on "Enhancement of laboratory biosafety"
Frequently Asked Questions: french - Dutch

The contained use of genetically modified micro-organisms (GMMs) or organisms (GMOs) and/or pathogens is regulated in Belgium at the regional level and is based on the implementation of European Directive 2009/41/EC (this new Directive repeals Directive 90/219/EEC and its successive amendments Directive 94/51/EC, Directive 98/81/EC and Decision 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 and pathogenic organisms for humans, animals and plants.

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 genetically modified and/or pathogenic 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.

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