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Biosafety Law, Regulation, Guidelines and Agreements
(LAW)
published: 12 Aug 2004
last updated: 24 Jan 2025
No
Besluit van de Vlaamse regering van 6 februari 2004 tot wijziging van het besluit van de Vlaamse regering van 6 februari 1991 houdende vaststelling van het Vlaams reglement betreffende de milieuvergunning, en van het besluit van de Vlaamse regering van 1 juni 1995 houdende algemene en sectorale bepalingen inzake milieuhygiëne
EN
Law
Sub-national (Flemish Region)
The Decree lays down common measures for the contained use of pathogenic and/or genetically modified micro-organisms and organisms with the view to protecting human health and the environment.
This Decree applies to the contained use in the Flemish Region of pathogens and/or genetically modified micro-organisms (GMM) and organisms (GMO). It transposes the European Directive 2009/41/EC.
EN
This Decree applies to the contained use in the Flemish Region of pathogens and/or genetically modified micro-organisms (GMM) and organisms (GMO). It transposes the European Directive 2009/41/EC.
01 Apr 2004
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.
The regulatory framework in the Flemish Region is the Decree of the Flemish Government of 6 February 2004 amending the Decree of 6 February 1991 and the Decree of 1st June 1995 (Belgian Offical Journal 01.04.2004, p. 18281).
The whole information that has to be given to notify a contained use activity represents the biosafety dossier. The dossier 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.
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.
The regulatory framework in the Flemish Region is the Decree of the Flemish Government of 6 February 2004 amending the Decree of 6 February 1991 and the Decree of 1st June 1995 (Belgian Offical Journal 01.04.2004, p. 18281).
The whole information that has to be given to notify a contained use activity represents the biosafety dossier. The dossier 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.
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.
