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Competent National Authority
(CNA)
published: 12 Aug 2004
last updated: 06 Jun 2024
Vlaamse Minister van Leefmilieu - Departement Omgeving
Graaf de Ferrarisgebouw
Koning Albert II-laan 20 bus 8
Brussels,
B-1000,
Belgium
- +32 2 553 80 11
- LNE [ English ]
Competent authority responsible for contained use matters in the Flemish Region.
The contained use of living modified organisms (genetically modified organisms) is regulated in Belgium at the regional level. The Regions (through their Ministry for the Environment) are responsible for the follow-up of administrative procedures, for authorizations and for inspections. Decisions are taken on the basis of a scientific advice, which is given in a centralized way by the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health or, in specific cases, by the Biosafety Advisory Council.
The contained use of living modified organisms (genetically modified organisms) is regulated in Belgium at the regional level. The Regions (through their Ministry for the Environment) are responsible for the follow-up of administrative procedures, for authorizations and for inspections. Decisions are taken on the basis of a scientific advice, which is given in a centralized way by the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health or, in specific cases, by the Biosafety Advisory Council.
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.
| Record type | Field | Record(s) | |
|---|---|---|---|
| Biosafety Law, Regulation, Guidelines and Agreements | Competent National Authority(ies) and/or Supplementary Protocol Competent Authority(ies) | 2 | |