As a member of the European Union, Belgium has to apply the EU legislation on GMOs (see report of the European Commission), that is based on the precautionary principle (cf. EU' s report).<br />Regulations of the EU are directly applicable by Member States. Some requirements of the regulations have been included in Belgian federal laws (for punishment in case of no respect of the regulations: in program law of 20 July 1992, modified by program law of 1 March 2007).<br />A Cooperation Agreement concerning Biosafety determines the repartition of competences relative to GMOs between the federal and regional levels. This cooperation agreement establishes a common structure for the Federal State and the Regions for the scientific assessment of GMOs, consisting in the Biosafety Advisory Council (BAC) and the Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health (linked to the Federal public Service for Health, Food Chain Safety and Environment). The BAC is composed&nbsp; of administrative and academic&nbsp; representatives appointed by the federal and regional competent authorities. It is assisted by external academic experts. The BAC advises the competent authorities about the safety for human health and the environment of any activities using GMOs, in particular the environmental release and the commercialisation of GMOs. The SBB is composed of a group of scientists with expertise in biosafety. It is in charge of the secretariat of the BAC. The SBB takes over the risk assessment of contained use activities, and offers scientific support to the BAC and to the federal and regional authorities in the field of GMO risk assessment.&nbsp; <br />Directives of the EU have been transposed respectively in federal and regional decrees, since different uses of GMOs are under different competences in Belgium: contained use is under regional competence (decree of the Brussels Region of 8 november 2001, of the Flemish Region of 6 February 2004, of Walloon Region of 4 July 2002, amended by decrees of 5 June 2008), deliberate release (Royal Decree of 21 February 2005) and placing on the market for direct food, feed or transformation are under federal competence (shared with regional competence for field trials for other purposes than placing on the market - part B of directive 2001/18/CE). <br />Guidances for coexistence have been established by the regional governments (decree of the Walloon Region of 27 March 2009, and of the Flemish Region of 3 April 2009), since agriculture is mainly under regional competence in Belgium. <br />Competent Authorities have been designated respectively for implementation of directive 2001/18/CE (deliberate release of GMOs), of regulation CE/1829/2003 (import and placing on the market for direct use as food/feed/tranformation), for regulation CE/1946/2003 (export of GMOs), for contained use of GMOs. National focal point for the Protocol and national focal point for the BCH have been designated. Have also been designated: -&nbsp; Federal controlers of field trials; - Federal controlers&nbsp; of content and labelling of products; - Regional Administrative staffs for the implementation of agriculture coexistence rules.

As all clinical trials, clinical research in gene therapy using living modified organisms falls under the scope of the Belgian law of 7 mai 2004 on experimentation on human beings implementing Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Such research activities also fall under the scope of Belgian biosafety regulation. In all cases, an authorisation must be obtained according to the Belgian regulations on contained use of GMOs and/or pathogen organisms which implement Directive 2009/41/EC. In the case of multicentre trials and/or for trials involving ambulatory medicine or the risk of shedding of GMOs by the patient into the environment, the Belgian regulation on the deliberate release of GMOs which implements Directive 2001/18/EC must also be applied.<br />To be placed on the market, all medicinal products derived from biotechnology (and therefore also medicinal products containing or consisting of GMOs) must obtain an authorisation issued by the European Commission upon advice of the European Medicines Agency (EMA). Access to the Community market for GMO medicinal products is subject to the centralised procedure laid down in Regulation (EEC) no. 2309/93, as amended by Regulation (EC) no. 726/2004. If authorisation is granted, it is automatically valid for all Member States of the European Union. Please refer to the European Commission report for more information.

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 (this Directive repeals Directive 90/219/EEC and its successive amendments). These Community measures ask for Member States to regulate the contained use of genetically modified micro-organisms in order to minimise their potential adverse effects on human health and the environment. Although the EU regulatory framework only covers genetically modified micro-organisms, 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 Biosafety and Biotechnology Unit (SBB), who acts as technical expert for the Regions. The full text of the three regional legislation is available from the BCH.<br />cf. EU' s report for transit.

cf. EU' s report.<br />As a Member State of the EU, Belgium participates in the authorisation procedure for the placing of the market of GMOs intended for intentional introduction into the environment. There were less than 5 GMOs in that case during the reporting period, and none of them is presently cultivated&nbsp; in Belgium for commercial purpose. <br />The placing&nbsp; on the BCH of the decision concerning an authorisation on the EU market is made by the European Commission.<br />During the reporting period, there was no application to a competent national authority in Belgium from a person or company out of the EU to obtain authorisation for the introduction of GMOs into the environment for experimental purposes, not intended for placing on the market.

cf EU's report.

cf EU's report.

BE, part of the EU, has not entered&nbsp; into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1).&nbsp; <br />cf. EU' s report.

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 Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health.<br />The BAC 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. In particular, it provides advices for all applications regarding the deliberate release of LMOs in the environment and the placing on the market of LMOs for cultivation, for food use, for feed use or for processing. The Council is composed of academic and administrative representatives appointed by the Regional and Federal competent authorities.<br />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 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.<br />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 spectific 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.

cf. EU' s report&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />Some precisions on Monitoring: the EU distinguishes a specific post-marketing monitoring (for risks identified during the risk assessment procedure) from a general post-marketing monitoring (for unforeseen adverse effects). <br />Till now, the notifiers and concerned GMOs operators are in charge of these 2 types of monitoring, that is mainly limited to the elements observable by these operators.<br />The European Commission envisages to more implicate the Member States, and national public networks on health and environmental monitoring in this GMO monitoring. In Belgium in particular, a study financed by the budget for the Federal public Service Health, Food Chain Safety &amp; Environment has shown that an adaptation of existing networks would be necessary to involve these networks in the monitoring of potential GMOs adverse effects. <br />Concerning the spatially and timely more limited monitoring of GMOs field trials not intended for placing on the market, a more accurate and operational mechanisme can already operate, accompanied by post-trials controls.

cf. EU' s report. <br />Belgium has a "Crisis cell" in its Federal public Service Health, Food Chain Safety &amp; Environment, where unintentional transboundary movements of LMOs likely to have significant adverse effects on biological biodiversity, including human health, should be communicated. Anyway, some precisions on information transmission and eventual emergency measures still have to be defined.

cf. EU' s report : EU legislation for GMOs is consistent with Article 18<br />Belgian customers have been informed on the requirements of Art. 18 and related COP-MOP decisions.<br />Concerned customers have followed Workshops organized by the Green Customs<br />However, in face of poorly sufficient custom' s staff, GMOs control is not always considered as a priority. Custom' s responsable staff especially deplore the absence of methods to distinguish, generally speaking, GMOs from non-GMOs; they consider that the availability&nbsp; of such methods would make their job relative to GMOs controlling more efficient.<br />In order to control the application of Art. 18 and its implementation through the EU legislation, the Belgian Federal Agency for Food Chain Safety is in charge of controlling the content and labelling (following the EU legislation)of food and feed products sold in shops and restaurants in Belgium and to control imported products considered as dubious by customers.

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

Belgium has provided all the required information directly in the BCH Central Portal. In addition, Belgium is running since 2001 a BCH national node, the "Belgian Biosafety Clearing-House" (BBCH - <a href="http://www.biosafetyprotocol.be">http://www.biosafetyprotocol.be</a>). This site is a basic website providing general information about the Cartagena Protocol and serving as a entry point for national information required under the Protocol. Detailed information on biosafety and LMOs is available on other national websites, in particular the "Belgian Biosafety Server" (BBS - <a href="http://www.biosafety.be">http://www.biosafety.be</a> - runned by the SBB since March 1996) and the GMO portal of the FPS Health Food Chain Safety and Environment (<a href="http://www.ogm-ggo.be">http://www.ogm-ggo.be</a>) set up in 2005.<br />Concerning answers to questions 124 j and m, Belgium did not furnish itself the information on the BCH: the European Commission furnishes to the BCH the answers that are also applicable for Belgium.

cf. EU's report.

Belgium is not a Party eligible to benefit from exterior funding for capacity-building, but would still need to develop its own capacities in various of the areas mentionned in question 147, for the purpose of an effective implementation of the Protocol, and more specifically in the areas mentionned in places 4, 5, 10, 11, 13 of question 147.

Following the EU legislation, BE, as a Member State of the EU, is in charge of consulting the public in the case of field trials of LMOs asked by notifiers to be undertaken in Belgium.<br />Besides, the Federal public service for Health, Food Chain Safety and Environment, that houses the national focal point of the Protocol and the federal competent authorities for the implementation of the EU legislation,&nbsp; has developped a website informative for the general public, on basic knowledge, legislations, activities and news around GMOs in BE and in the EU.

cf. EU' s report&nbsp; &nbsp; <br />Following our knowledge, transboundary movements of LMOs from Belgium to third countries concern mainly LMOs developped in contained use in Belgium and intended for field trials in non Parties (mainly USA).

cf EU's report.

Belgium has participated through its contributions of informations and opinions to the recent European Commission report on socio-economic implications of GMOs cultivation. <br />Belgium has participated through its National focal Point in the recent online forum of discussions and conference on this subject organized by the Secretariat of the Protocol.

Belgium has signed the Supplementary Protocol in NY on September 20 at a ceremony taking place during the high-level event on desertification of the 66th session of the UN assembly. <br />cf. EU' s report: since the adopted Supplementary Protocol is fully consistent with the EU legislation, no further action at the European Union level and its Member States seems necessary to ratify this agreement.

Socio-economic considerations were taken into account for national approvals for 2 field trials of GM trees in Belgium. One for apple trees, before 2004. The Minister for public health and environment established a provisional committee, giving an opinion based on ethical and socio-economic considerations, in addition to the usual biosafety concerns considered by the Biosafety Belgian Advisory Council. The opinion of that committee was unfavorable, and so was the final decision for the field trial. More recently, the federal Ministers for health and environment took a negative decision for field trials of poplar trees, after a positive advice submitted to risk management conditions of the Biosafety Belgian Advisory Committee. The negative decision was based a.o. on public concerns and on doubts about the societal benefit and therefore the sustainability of the GM poplars ( developed for biofuels to be used in transportation ). The applicant went to the administrative Court. The State Council gave reason to the applicant, considering that the arguments for a negative decision were not justified enough and should have been based according to the legislation derived from EU law only on risk concerns, especially for a field trial level of dissemination in the environment.