Agreement concerning Biosafety
February 28, 2006
version of the Cooperation Agreement (Dutch - French)
Agreement between the Federal State and the Regions on the administrative
and scientific co-ordination concerning Biosafety establishes
a single scientific advisory system common to the Federal and Regional
authorities. Thanks to this system, all scientific aspects
related to the uses of genetically modified organisms (GMOs) and pathogens
are assessed altogether in a coordinated way, independently of the
specific concerned regulation(s).
The cooperation agreement aims at:
- transposing European Directives concerning
GMOs and GMO-based products in an harmonised way;
- establishing a common scientific evaluation system between
the federal State and the Regions for all biosafety-related matters;
- co-ordinating the implementation of the above-mentioned Directives at the
regional, federal and international levels.
The common scientific evaluation
system is composed of the Biosafety Advisory Council and the Service
of Biosafety and Biotechnology.
The Biosafety Advisory Council (BAC)
advices the competent authorities about the safety of any activities using
GMOs and pathogens, including genetic and ecological aspects related to
The missions, composition and functioning of the Council are described in article
5 to 11 of the Cooperation Agreement.
The Council can be consulted by the Regions or the SBB for the contained
use activities (laboratories, greenhouses, animal husbandries, production
plants). It must be consulted for the deliberate release of GMOs in the environment
and the placing on the market of all GMOs and GMOs-based products.
The Council consists of representatives of the Regional and Federal authorities.
It is assisted by experts in its scientific work. The secretariat of the
Council is ensured by the SBB.
of Biosafety and Biotechnology (SBB) is
composed of an administrative secretariat, a multidisciplinary group of
scientists and a laboratory for biosafety research and expertise.
to the Cooperation agreement (articles 12 and 18), the SBB is mainly in charge
of the following practical tasks:
- risk assessment of contained
the SBB defines the specific normative criteria to be applied in a given
installation on a case by case basis and advices the Regional authority
about the licencing conditions from the biosafety viewpoint;
- risk assessment of applications
for the deliberate release of GMOs in the environment
or for the placing on the market of GMOs, GMO-based or GMO-derived
products, for which the SBB has been mandated by the Biosafety Advisory
- secretariat of the Biosafety
- proposal of protection measures
related to human health and the environment, to the attention of the Biosafety
or the authorities;
- archiving of the biosafety dossiers
and safeguard of confidential information;
- communication of relevant information
to the European Commission in the framework of the follow-up of EU
Directives pertaining to GMOs;
- scientific support to the
Belgian delegation at international meetings.
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