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Contained
Use of GMOs and pathogens
Regulatory framework and procedures in the Flemish
Region
(Last revised:
February 14, 2011
)
| Contacts |
 Regional
Authorities Biosafety and Biotechnology Unit |
| Documentation |
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Forms to be used for notifications |
| Regulatory framework in force |
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Decree
of the Flemish Government of 6 February 2004 amending
the Decree of 6 February 1991 and the Decree of 1st June 1995 [Full text in PDF format - extract from the Belgian Official Journal - in French and in Dutch] Decree
of the Flemish Government of 24 March 1998 amending the decree of the Flemish
Government of 1st June 1995 Decree
of the Flemish Government of 1st June 1995 (chapter 5.51. of VLAREM II - Biotechnology)
(HTML version in Dutch) Decree
of the Flemish Government of 6 February 1991 (VLAREM I)
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Procedures |
| Procedures for first and subsequent contained uses |
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 "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" (BS 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), who acts as technical expert for the Region.
In order to facilitate the information and notification procedures and to limit at the minimum the administrative constraints for the notifiers, the SBB has, in collaboration with the Regional competent authority, developed notification forms and a user guide, on the basis of the requirements of the regional decree but also of the experience gained as regards implementation of this regulation.
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