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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.

Full text of the Royal Decree (in Dutch - in French).

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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