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Contained use of GMOs and pathogens
(Last revised: May 26, 2016 )


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.


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

* Fumigation: Revision of the classification of formaldehyde
* Tools for Risk Assessment and Risk Management with Guidelines, Recommendations, Technical notes , Weblinks

* Sampling feasibility study of pathogenic organisms genetically modified or not in contained use activities (PDF 1.2 MB)

The aim of this study is to discern situations where sampling may be feasible and relevant. Both will be determined by the probability of subsisting biological risks arising from a contained use activity. Notwithstanding biological risks may harm the environment, this study will primarily focus on the feasibility of sampling in situations where subsisting biological risks may present a danger for public health. Therefore this report serves as a guideline for inspectors to i) evaluate the potential biological risks for human health ii) consider technical and practical aspects in order to perform sampling in the best conditions and iii) highlight issues encountered during the interpretation of sampling results.

* Bio-incidents and Laboratory-acquired infections: short introduction, references and recently reported laboratory-acquired infections

* Recently reported Laboratory-Acquired Infections or related studies

* High Level Containment Facilities in Belgium, Reporting period 1995-2008 (PDF 2.2 MB) available in French - in Dutch
* 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 Biosafety and Biotechnology Unit (SBB), who acts as technical expert for the Regions.

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