Belgium | BCH-NR2-BE-102482 | Second National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Second National Report on the Implementation of the Cartagena Protocol on Biosafety (NR2)

last updated: 07 Oct 2011
General Information


Competent authorities at the federal and regional levels.<br />SBB (Biosafety and Biotechnoly Unit of the Scientific Institute of Public Health).<br />Secretariat of the national Biosafety Advisory Council.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; ]
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01 Oct 2007
30 Sep 2011
Party to the Cartagena Protocol on Biosafety
Article 2 – General provisions
A domestic regulatory framework is fully in place
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  • One or more national biosafety laws
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
Yes
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Yes
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More than 10
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Yes
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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.
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Article 5 – Pharmaceuticals
Yes
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Yes
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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.
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Article 6 – Transit and Contained use
Yes
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Yes
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Yes
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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.
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Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
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Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
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Less than 5
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Less than 5
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Less than 5
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Less than 5
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Yes, always
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Yes, always
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n/a
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n/a
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n/a
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n/a
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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.
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Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
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Yes
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Yes
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Yes
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No
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No
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Yes
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More than 10
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More than 10
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More than 10
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Yes, always
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Yes, always
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cf EU's report.
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Article 12 – Review of decision
Yes
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No
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No
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None
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Article 13 – Simplified procedure
No
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No
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None
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cf EU's report.
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Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
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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.
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Article 15 – Risk assessment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
Yes
EN
Yes, always
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Yes, always
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More than 10
EN
Yes, always
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Yes, always
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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.
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Article 16 – Risk management
Yes, to some extent
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Yes, to some extent
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Yes
EN
Yes
EN
Yes
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Yes
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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.
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Article 17 – Unintentional transboundary movements and emergency measures
Yes
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Yes
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No
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