Belgium has managed an harmonized implementation in the national laws of the European biosafety legislation. 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 living modified organisms (= genetically modified organisms – GMOs) and pathogens are assessed altogether in a coordinated way, independently of the implicated specific regulation(s).
The legal basis of such a framework is the "Cooperation Agreement between the Federal State and the Regions on the administrative and scientific coordination concerning biosafety". This cooperation agreement establishes a common scientific evaluation system for the Federal State and the Regions, consisting of the Biosafety Advisory Council and the Biosafety and Biotechnology Unit (SBB).
The Biosafety Council advises the competent authorities about the safety for human health and the environment (including genetic and ecological aspects related to biodiversity) of any activities using GMOs, in particular the deliberate release of GMOs in the environment and the placing on the market of GMOs, GMO-based or GMO-derived products. The Council consists of representatives of the Regional and Federal competent authorities. It is assisted by experts organised in thematic ad hoc groups.
The Biosafety and Biotechnology Unit (SBB) is in charge of the secretariat of the Biosafety Council. It is composed of an administrative secretariat and a multidisciplinary group of scientists. The SBB advises the Regional competent authorities about the biosafety of contained use activities involving GMOs and/or pathogens. It provides also permanent scientific support to all competent authorities in Belgium and to the Biosafety Council.
European Directive 2009/41/EC related to the contained use of genetically modified micro-organisms (GMMs) has been implemented (with a scope extended to genetically modified organisms and pathogens) as part of the Regional Environmental laws for classified installations.
The contained use of genetically modified (and/or pathogenic) organisms is regulated in Belgium at the regional level. The Regions (and more specifically the Ministries for the environment) are responsible for the follow-up of administrative procedures, for authorizations and for inspections. The biosafety evaluation is performed by the SBB or, in specific cases, by the Biosafety Advisory Council.
Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms has been transposed into national legislation via the Decree of 21 February 2005 on the deliberate release into the environment and the placing on the market of GMOs or GMO-containing products.
For the placing on the market of GMOs, all political decisions are taken by the Federal Minister for Consumer Protection, Public Health and Environment. At the administrative level, depending on the potential field of application of the GMO, the Federal Public Service (FPS) Health, Food Chain Security and Environment or the Federal Agency for Medicines and Health Products are involved. For the experimental release of GMOs in the environment, the Federal authority shares the final co-decision with the above-mentioned Regional authorities. For these matters, the Biosafety Advisory Council is the common advisory body for all competent authorities.
Rules for coexistence of genetically modified crops with conventional and organic agriculture have been adopted by the regional governments, since this matter is under regional competence in Belgium