According to article 19 of the Cartagena Protocol on Biosafety, each Party shall designate one or more competent national authority(ies), which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions.
In Belgium, different authorities have responsibilities in the field of living modified organisms (genetically modified organisms), depending on the intended use of the organisms.
- LMOs destined for contained use
- LMOs destined for intentional introduction into the environment
- LMOs intended for direct use as food or feed, or for processing (LMO-FFPs)
- LMOs in transit
- Exports of LMOs from Belgium outside the EU
LMOs destined for contained use
The contained use of living modified organisms (genetically modified organisms) is regulated in Belgium at the regional level. The Regions (through their Ministry for the Environment) are responsible for the follow-up of administrative procedures, for authorisations and for inspections. Decisions are taken on the basis of a scientific advice, which is given in a centralized way by the Service Biosafety and Biotechnology (SBB) of Sciensano and, in specific cases, by the Biosafety Advisory Council.
Contact details for each regional competent authority can be found on the Belgian Biosafety Server:
LMOs destined for intentional introduction into the environment
The intentional introduction of living modified organisms (genetically modified organisms) into the environment in Belgium may proceed only if a consent has been given in advance by the relevant competent authorities.
- In case of intentional introduction of LMOs (GMOs) into the environment for research and development or for any other purposes than placing on the market, one or several regional authorities (see below) participate in a co-decision procedure with the relevant federal competent authority (see below).
- When LMOs (GMOs) are introduced into the environment as or in products ("placing on the market"), the federal authority is the only one to be competent at the Belgian level. However, the final consent has to be given at the European Union level to allow the LMO (GMO) to be used throughout the EU.
Competent authorities or administrations at the federal level
All final 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 LMO, the following administration is competent at federal level :
- For Plant varieties and animal lines/races; Seeds; Phytopharmaceuticals, Biopesticides; Fertilizers and soil improvements : Federal Public Service (FPS) Health, Food Chain Safety and Environment - DG4
- For Medicinal products for veterinary uses: Federal Agency for Medicines and Health Products
- For products different from those previously listed, please contact FPS-DG4 for further information.
Competent authorities or administrations at the regional level
Contact details for each regional competent authority can be found on the Belgian Biosafety Server:
LMOs intended for direct use as food or feed, or for processing (LMO-FFPs)
The direct use of living modified organisms (genetically modified organisms) as food or feed, or for processing may proceed only if a consent has been given by the relevant federal competent authority (Federal Minister for Consumer Protection, Public Health and Environment, with administration at the Federal Public Service (FPS) Health, Food Chain Safety and Environment). However, the final consent has to be given at the European Union level to allow the LMO (GMO) to be used throughout the EU.
LMOs in transit
One additional national competent authority has been designated according to the European Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms. This Regulation has been adopted to implement some of the requirements of the Protocol, in particular regarding exports of GMOs to third countries.
Exports of LMOs from Belgium outside the EU
The export of living modified organisms (genetically modified organisms) from the EU to third countries may proceed according to the requirement of the Regulation on transboundary movements of GMOs.
According to this Regulation, exports of GMOs intended for deliberate release into the environment should be notified to the Party or non-Party of import, allowing it to make an informed decision, based on a risk assessment carried out in a scientifically sound manner. The notification should be ensured by the exporter. The exporter should be responsible for the accuracy of the information provided in the notification. Exporters should await the prior written express consent of the Party or non-Party of import before proceeding with the first transboundary movement of a GMO intended for deliberate release into the environment.
In Belgium, all relevant administrative functions related to the export of GMOs from Belgium outside the EU territory are performed by the Federal Public Service (FPS) Health, Food Chain Safety and Environment.