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Introduction
Belgium is a federal state, composed of communities and regions​. To avoid disparities between the different entities sharing competencies in the field of biosafety (in particular the federal state and the regions) a harmonised implementation of the European regulatory framework on biosafety has been necessary. As a result, decisions by different administrative bodies representing different institutional levels are based on a single science-based biosafety advisory system. In this system, all regulatory-related aspects of the uses of GMOs and pathogens are assessed in a coordinated way, independently of the specific regulation(s) involved.
This legal basis for this centralised biosafety advisory system is the Cooperation Agreement of 25 April 1997 concerning biosafety​.​​​
According to the Cooperation Agreement, biosafety-related expertise is carried on in Belgium by two complementary bodies: the Biosafety Advisory Council and the Service Biosafety and Biotechnology (SBB) of Sciensano.
- Biosafety Advisory Council: Missions and functioning
- SBB: A permanent centre of expertise in biosafety
Belgium has kept in its biosafety legislation the distinction introduced at EU level between the use of GMOs in a contained environment on the one hand and, on the other hand, their deliberate release into the environment.
Contained use
"Contained use" refers in Belgium to activities involving genetically modified and/or pathogenic micro-organisms, as well as genetically modified plants or animals, in a "closed environment" such as laboratories, animal units, greenhouses and production units. They mainly include diagnostics, R&D and large-scale activities. Manipulating and administering GMOs in clinical trials is also considered "contained use"​.
In Belgium these activities are regulated at regional level as a part of the environmental laws for classified installations. Since contained use also includes activities involving pathogens, a close relationship with the federal regulation on workers protection​ exists.
- Full text of the regional Decrees
- Implementation of the contained use legislation in Belgium - Historical background
- Contained use activities in Belgium - Some figures​
- Protection of workers exposed to biological agents at work​​
Deliberate release
"Deliberate release" means any intentional introduction into the environment of a GMO for which no specific containment measures are used to limit its contact with the general population and the environment​. It includes field trials with GM plants, some clinical trials with GMOs, commercial cultivation of GM plants, commercialisation of GM food and feed, and commercialisation of GMO-based medicinal products for human or veterinary use.
In Belgium, the relevant EU legislation​ has been transposed at federal level but the implementation involves both federal and regional entities.
- Belgian legislation governing the environmental release or commercialisation of GMOs​
- Implementation of the deliberate release legislation in Belgium - Historical background
- Regulatory dossiers - Organisation at Belgian level of the scientific assessment
- Detailed information about environmental releases of GMOs in Belgium (database): Field trials ​with GM plants and clinical trials with GMOs
- Detection, identification and quantification of GMOs in the environment and in food and feed: this task is performed by the National Reference Lab on GMOs