See EU answer

The implementation of the Cartagena Protocol in Belgium is ensured through a set of regulatory instruments, most of which corresponding to the direct application or the transposition in Belgian law of EU legal provisions. Many of these legal instruments were also in place largely before the adoption of the Cartagena Protocol. These regulatory instruments cover in particular the contained use of GMOs, their environmental release (for R&D and for commercialization), their use as food or feed, their transboundary movements, and their coexistence with non-GM and organic agricultural products. Since competencies on GMO matters are shared between the Federal State and the three Regions, a cooperation agreement between all the competent entities has been established since 1997 to manage in an harmonized way the administrative and scientific implementation of the Belgian GMO regulatory framework. As a result, decisions by different administrative bodies representing different institutional levels are based on a single science-based biosafety advisory system, composed of the Belgian Biosafety Advisory Council (BAC) and the Service Biosafety and Biotechnology (SBB) of Sciensano (formerly Scientific Institute of Public Health). In this system, all regulatory-related aspects of the uses of GMOs and pathogens are assessed altogether in a coordinated way, independently of the specific regulation(s) involved. Competent Authorities (supported by permanent and temporary experienced staff) have been appointed for all regulatory matters related to the implementation (including control) of the Cartagena Protocol. This implementation is also supported by guidelines developed at Belgian or EU level. National focal points for the Protocol and for the BCH have also been designated. For more information about the Belgian biosafety framework, please refer to the BCH.

We refer to the 4th national report of Belgium as no changes have been observed since

The contained use of genetically modified micro-organisms (GMMs) or organisms (GMOs) and/or pathogens is regulated in Belgium at the regional level and is based on the implementation of European Directive 2009/41/EC. These Community measures ask for Member States to regulate the contained use of GMMs in order to minimise their potential adverse effects on human health and the environment. Although the EU regulatory framework only covers genetically modified microorganisms, the scope of the Belgian regional legislations has been extended to genetically modified organisms and pathogenic organisms for humans, animals and plants. 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 genetically modified and/or pathogenic 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) of Sciensano, who acts as technical expert for the Regions. The full text of the three regional legislation is available from the BCH. See EU' s report for transit.

We refer to the EU report for further details

We refer to the EU answer.

We refer to the EU report

We refer to the EU answer

BE, part of the EU, has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1).

Belgium has implemented a comprehensive system for risk assessment dealing with all uses of LMOs. Accordingly, all regulatory-related aspects of the uses of LMOs are assessed altogether in a coordinated way, independently of the specific concerned regulation(s). The main legal basis is the "Cooperation Agreement between the Federal State and the Regions on the administrative and scientific coordination concerning Biosafety" (1997). This cooperation agreement establishes a common scientific evaluation system for the Federal State and the Regions, consisting in the Biosafety Advisory Council (BAC) and the Service for Biosafety and Biotechnology (SBB) of Sciensano. The BAC advises the authorities for all regulatory dossiers related to the placing on the market of products consisting of or containing GMOs, for applications for field trials of transgenic plants, and for applications relating to clinical trials in which a release of GMO into the environment is possible. The Council can be consulted by the Regions for contained use activities involving GMOs. The BAC is composed of academic and administrative representatives appointed by the Regional and Federal competent authorities. The SBB is in charge of the secretariat of the Biosafety Council. It is composed of an administrative secretariat and a multidisciplinary group of scientists. The SBB advises the regional authorities in relation to the use of pathogens and GMOs under contained conditions. It provides permanent scientific support to the BAC and to the competent Federal and Regional authorities in the field of risk assessment of LMOs, including in official fora at EU (Council, Commission, EFSA, EMA) and international (OECD, UN) level. In the framework of the scientific evaluation of regulatory dossiers and other biosafety-related matters, the BAC and the SBB frequently call for the scientific support of external experts coming from Belgian (and sometimes foreign) academic institutions. For this purpose, a list of experts has been compiled in a database. Experts are consulted on a case by case basis, depending of the specific expertise needed in the frame of the evaluation of a dossier. The expertise is most of the cases done according to a written procedure. The experts are entitled to receive a financial allowance for their scientific work. This cooperation with scientific experts is very important to deliver scientifically sound advices to the competent authorities. It also makes it possible to involve Belgium's academic community in biosafety matters. Furthermore, many scientists see an increase in the value of their research work due to their contributions to the BAC and SBB expertise.

Article 14 of EU Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures. Belgium has a "Crisis cell" in its Federal public Service Health, Food Chain Safety & Environment, where unintentional transboundary movements of LMOs likely to have significant adverse effects on biological biodiversity, including human health, should be communicated.

With regards to GMO detection and identification, Belgian is part of the European Network of GMO Laboratories (ENGL). The main missions of the ENGL are the development, harmonisation and standardisation of sampling, detection, identification and quantification methods for GMOs or GMO-derived products from a wide variety of matrices, covering seeds, cereals, foodstuffs, animal feed and environmental samples. The Belgian component of the ENGL, namely the National Reference Laboratory for Genetically Modified Organisms (NRL-GMO), was officially set up in 2006. It is made up of Sciensano (the federal laboratory for the GMO detection), the ILVO (Flemish Institute for Agricultural and Fisheries Research) and the CRA-W (Walloon Agricultural Research Centre). The NRL-GMO is coordinated by Sciensano. It works to support the Belgian Federal Agency for the Safety of the Food Chain (FASFC) within the context of implementing Regulation (EC) 1830/2003 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs. In particular, it has the task of promoting the application and development of new GMO detection, identification and quantification methods in food matrices. The European consortium ENGL, including the Belgian NRL-GMO, works to support the European Union Reference Laboratory for GM Food and Feed (EURL-GMFF, formerly the Community Reference Laboratory), which was established in accordance with the provisions of Regulation (EC) 1829/2003 on GM Food and Feed. The main task of the EURL-GMFF is the scientific assessment and validation of detection methods supplied by notifiers within the framework of marketing authorisation applications for GMO food or feed

Permanent staff members have been designated respectively as: • National focal Point of the Protocol • National focal point of the BCH • Federal Competent Authority for the placing on the market and import of GMOs intended for deliberate release into the environment. • Federal Competent Authority for the import of GMOs directly intended for food and feed. • Federal Competent Authority for the export of GMOs Are also designated as permanent staff: • National Secretariat of the Biosafety Advisory Council (the members of this last organ can be renewed every 4 years) • Regional Competent Authorities for the contained use of GMOs (responsible for the follow-up of administrative procedures, for authorisations and for inspections) • Regional Competent Authorities for the implementation of agriculture coexistence rules.

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In the period 2022-2025, there were two notifications by a company exporting a LMO to the United States.

Illegal transboundary movements were observed both from and to Belgium. From Belgium, there were two cases of contaminated bird feed transported to Switzerland. This was notified by the Swiss authorities and followed up by the competent authority in Belgium. This information is available as well in the BCH.

See Q174

Walloon Region: - 22 novembre 2007 Décret modifiant le Livre Ier du Code de l'Environnement en ce qui concerne la prévention et la réparation des dommages environnementaux - 3 juin 2016. — Décret modifiant le Code de l’Environnement, le Code de l’Eau et divers décrets en matière de déchets et de permis d’environnement Flanders Region: Decreet van 5 april 1995 houdende algemene bepalingen inzake milieubeleid, titel XV Milieuschade. Brussels Capital Region - 25 MARS 1999. - Code de l'inspection, la prévention, la constatation et la répression des infractions en matière d'environnement et de la responsabilité environnementale, (art. 4 ; 20 ; 21, § 1, 6 ; 24-30 ; 57) - 19 MARS 2009. - Arrêté du Gouvernement de la Région de Bruxelles-Capitale précisant certaines dispositions de l'ordonnance du 13 novembre 2008 relative à la responsabilité environnementale en ce qui concerne la prévention et la réparation des dommages environnementaux. Federal level : - Koninklijk besluit betreffende de preventie en het herstel van milieuschade bij het in de handel brengen van genetisch gemodificeerde organismen of van producten die er bevatten - 8 NOVEMBER 2007. - Koninklijk besluit betreffende de preventie en het herstel van milieuschade tengevolge van het vervoer over de weg, per spoor, over de binnenwateren of in de lucht van : uitheemse plantensoorten evenals van uitheemse diersoorten en hun krengen, naar aanleiding van de in-, de uit- en de doorvoer ervan; alsook van afvalstoffen bij hun doorvoer