- General Provisions
- Imports of LMOs destined for contained use
- Imports of LMOs destined for intentional introduction into the environment
- Imports of LMOs intended for direct use as food or feed, or for processing (LMO-FFPs)
- Exports of LMOs to third countries
Belgium has managed an harmonised implementation of European Directives, Decisions, Regulations and Guidelines related to living modified organisms (genetically modified organisms). The decisions taken by different administrative bodies representing different institutional levels (see "Competent Authorities") are mainly based on a single common science-based biosafety advisory system. In such a system, all regulatory-related aspects of the uses of LMOs (GMOs) are assessed altogether in a coordinated way, inside the same procedures, independently of the specific regulation(s) involved. The advice on the safety for human health and the environment is given on a case by case basis taking the precautionary principle as priority.
The legal basis of this framework is the "Cooperation Agreement between the Federal State and the Regions on the administrative and scientific coordination concerning Biosafety".
The summary and full text of the Cooperation agreement are available on the Belgian Biosafety Server.
This cooperation agreement establishes a common scientific evaluation system for the Federal State and the Regions, consisting of the Biosafety Advisory Council and the Service Biosafety and Biotechnology of Sciensano (SBB).
The Biosafety Advisory Council advises the competent authorities about the safety for human health and the environment (including genetic and ecological aspects related to biodiversity) of any activities using LMOs (GMOs), in particular the deliberate release of LMOs in the environment and the placing on the market of LMOs, LMO-based or LMO-derived products. The Council consists of representatives of the Regional and Federal competent authorities. It is assisted by experts organised in thematic ad hoc groups.
The Service Biosafety and Biotechnology (SBB) of Sciensano is in charge of the secretariat of the Biosafety Council. It is composed of an administrative secretariat and a multidisciplinary group of biosafety scientists. The SBB also offers permanent scientific support to the Biosafety Advisory Council and to the competent Federal and Regional Authorities in the field of risk assessment of activities involving GMOs and/or pathogens. As part of a Federal scientific Institute, the SBB holds an independent position with regard to expertise in Biosafety, accessible to any public or private organisation including NGOs, consumer organisations, industry, universities, schools.
The Belgian legislation on the contained use of LMOs (living modified organisms) - referred to in Belgium as GMOs (genetically modified organisms) - is based on the implementation or the enforcement of European Directive 2009/41/EC (repealing Directive 90/219/EEC). These EU measures ask for Member States to regulate the contained use of genetically modified micro-organisms in order to minimise their potential negative effects on human health and the environment. Although the EU regulatory framework only covers genetically modified micro-organisms (GMMs), the scope of the Belgian regional legislations has been extended to genetically modified organisms. Moreover, considering that the safety of manipulations involving GMMs and GMOs is assessed taking into account the characteristics of the recipient and donor (micro-)organisms and in particular their pathogenicity for humans, animals or plants, pathogenic organisms have also been included into the scope of the regional legislations.
The contained use of LMOs (GMOs) is regulated in Belgium at the regional level. The three Regions (Flanders, Wallonia and Brussels-Capital) have implemented the above-mentioned EU legislation as part of their Environmental laws for classified installations. In such a general context, biosafety is just one of the safety issues covered by the environmental permit.
All activities in laboratories, animal houses, greenhouses, hospital rooms and large-scale production facilities involving living modified organisms (genetically modified organisms) are subject to a preliminary written authorisation from the relevant regional competent authorities on the basis of a specific notification and decision procedure. During the procedure, the risk assessment is submitted for advice to the Service Biosafety and Biotechnology (SBB), who acts as technical expert for the Regions.
For more information about the procedural aspects, visit the relevant chapter of the Belgian Biosafety Server.
The Belgian legislation covering the intentional introduction into the environment of LMOs (living modified organisms) - referred to in Belgium as GMOs (genetically modified organisms) - implements or enforces the European Directive 2001/18/EC of 12 March 2001 repealing Directive 90/220/EEC of 23 April 1990, and subsidiary EU Decisions. Through these EU regulatory measures, Member States are required "to regulate the deliberate release into the environment of genetically modified organisms in order to minimize their potential negative effects on human health and the environment".
At the Belgian level, Directive 2001/18/EC has been transposed into national legislation via the Royal Decree of 21 February 2005 on the deliberate release into the environment and the placing on the market of GMOs or GMO-containing products.
The full text of the Royal Decree is available from the "Belgian Biosafety Server" in French and in Dutch.
The intentional introduction in Belgium of a GMO (or a combination of GMOs) into the environment for the purpose of research and development, or for any other purpose than for placing on the European Union (EU) market, is forbidden. The notifier may proceed with the intentional introduction into the environment only when he has obtained the consent of the competent authorities.
Any person wishing to undertake such an introduction must submit a notification to the relevant Belgian competent authorities. This notification shall include a technical dossier of information including a full risk assessment.
When LMOs (GMOs) are introduced into the environment as or in products ("placing on the market"), a similar procedure applies. However, the final consent has to be given at EU level to allow the LMO (GMO) to be used throughout the EU.
At the European Union level, applications for LMOs that will be used as food or feed or for processing have to be submitted according to Regulation (EC) 1829/2003. The final consent is given at EU level to allow the product to be used throughout the EU, after a scientific evaluation undertaken under the responsibility of the European Food Safety Authority (EFSA).
In order to ensure compliance with the obligations of the Protocol regarding transboundary movements of LMOs (GMOs), the EU has established a common legal framework for exports of LMOs (GMOs) to third countries, the Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms.
According to this Regulation, exports of LMOs (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 LMO (GMO) intended for deliberate release into the environment.
With regards to traceability, labelling and identification of LMOs (GMOs), the Regulation foresees that similar rules apply to LMOs (GMOs) being exported from or imported into the EU.