Belgian Regulatory Framework on biosafety

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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.

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.

 

Deliberate relesease

"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.