The Cooperation Agreement between the Federal State and the Regions on the administrative and scientific coordination concerning biosafety was adopted on 25 April 1997.
=> Full text of the Cooperation Agreement (PDF File - In Dutch and in French)
The Cooperation Agreement is the end result of a long negotiation process that started even before the adoption of the first EU Directives on biosafety.
=> Historical steps in the development of the Cooperation Agreement on Biosafety
The main objectives of this Cooperation Agreement are:
- to transpose into national law and apply in a harmonised manner Directive 90/219/EEC (now repealed by Directive 2009/41/EC) regulating the contained use of genetically modified microorganisms, while extending this regulation to genetically modified organisms and pathogenic organisms. The Regions also committed to harmonising technical biosafety criteria and the classification of GMOs and pathogenic organisms and their classes of risk;
- to transpose into national law and apply in a coordinated manner Part B of Directive 90/220/EEC (now repealed by Directive 2001/18/EC) on the deliberate release of GMOs into the environment for the purposes of research or development and any purposes other than placing on the market;
- to set up a biosafety scientific evaluation system common to the Federal State and Regions, comprising a "Biosafety Advisory Council" and the "Service Biosafety and Biotechnology" (SBB) located at Sciensano;
- to coordinate regulatory provisions applicable to the management of waste from contained use activities, so that in case where such substances containing living GMOs were to be placed on the market, the provisions concerning deliberate release would be applicable.
The Cooperation Agreement also sets the definition of "biosafety", for legal purposes, in Belgium (Article 1). Biosafety is defined as "the safety for human health and the environment, including the protection of biodiversity, related to the use of genetically modified organisms or microorganisms, and to the contained use of organisms pathogen for humans".
This definition implies that all biological risks are managed within a single scientific and regulatory process. In this model, biological risks linked to well-known nuisances resulting from the pathological, toxicological or allergenic effects of pathogenic organisms are managed as such, but also serve as historical, medical, environmental and scientific references for the assessment and management of risks and uncertainties linked to genetically modified organisms. Biosafety applies to all types and uses of GMOs.
By providing, in this definition, for the protection of biodiversity during the use of GMOs, Belgium also established a legal link between biosafety and the concept of sustainable development, which was taken up a few years later as one of the basic principles of the Cartagena Protocol on Biosafety, an international treaty regulating the exchange of GMOs between countries.
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The Cooperation Agreement concerning biosafety is the central legal text that regulates the implementation and management of biosafety in Belgium. It was formally approved at federal and regional levels through specific legal texts:
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