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The Belgian
regulatory framework concerning Biosafety
(Last revised:
June 15, 2009
)
General Provisions
Belgium has managed an harmonized implementation in the Belgian laws of European Biosafety Directives, Decisions, Regulations and Guidelines. The decisions by different administrative bodies representing different institutional levels are mainly based on a single common science-based biosafety advisory system. In such a system, all regulatory-related aspects of the uses of GMO's and pathogens are assessed altogether in a coordinated way, independently of the implicated specific regulation(s).
This common advisory system is founded by a Cooperation Agreement concerning Biosafety.
Specific Provisions
Deliberate release of GMOs in the environment
and placing on the market of GMOs
The European legislation in this field has been transposed in the Belgian
law
by the Royal
Decree of 21 February 2005 .
This Decree implements or enforces Directive
2001/18/EC and
subsidiary Decisions.
The Decree is completed by the "Arrêté ministériel du 18 octobre 2006 relatif à la désignation du service de contrôle mentionné à l'article 2, 19°, deuxième tiret, de l'arrêté royal du 21 février 2005" (text in PDF).
In addition to the Decree of 21 Februari 2005, the two following Laws are also of application:
- Law of July 20, 1991, especially article 132 (provisions concerning the deliberate release in the environment of genetically modified organisms)
- Law of February 22, 1998 (amending the law of July 20, 1991), especially articles 222 and 226.
Contained Use of pathogenic and/or
genetically
modified
organisms, including clinical research
The European legislation has been transposed at Regional level as a part of
the Regional
Environmental laws for classified installations.
Full text of the regional
regulations (in Dutch - in French).
These regulations implement the 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).
Protection of workers exposed to biological agents at work
The legislation currently in force in Belgium is the Royal Decision of April 29, 1999 (Belgian Official Journal of 07.10.1999 - p. 37917) amending the Royal Decision of August 4, 1996 concerning the protection of workers from risks related to exposure to biological agents at work (Belgian Official Journal of 01.10.1996 - p. 25285).
This decision implements European Directives 90/679/EEC, 93/88/EEC, 95/30/CE, 97/59/CE and 97/65/CE.
Directive 90/679/EEC has been repealed in September 2000 by Directive
2000/54/EC.
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