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	Belgian Biosafety Advisory Council
Documentation

Index Statute Internal Rules Composition Meetings of the members Running Procedures Concluded Procedures Advices of the Council Expert Groups Documents and Publications Useful documentation Press Links Contact

Role and interventions of the Council in the regulatory procedures for dossiers 2001/18/EC on deliberate release of GMO (last update: 24/10/2006)   Directive 2001/18/EC distinguishes 2 types of dossiers: Dossiers Part B "deliberate release of GMOs for any other purpose than for placing on the market" Dossiers Part C "for placing of the market of GMOs as or in products" The procedures for a dossier part B or a dossier part C are summarized in the 2 diagrams below. For the scientific evaluation of those dossiers the experts can refer to several available guidelines applicable to higher plants or micro-organisms. European documents Annex II of Directive 2001/18: Principles for the environmental risk assessment (pdf) COMMISSION DECISION 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. (OJ L 200, 30.7.2002, p. 22) (pdf) OECD documents Safety Assessment of Transgenic Organisms: OECD Consensus Documents, Vols. 1 and 2 (24 juli 2006) (link on the site of OECD) Consensus Documents for the Work on Harmonisation of Regulatory Oversight in Biotechnology (link on the site of OECD) Belgian documents concerning partB dossiers Protocols for field releases of transgenic plants (2002 et 2003) (link on the Belgian Biosafety server) Guidance notes for the compilation of the public dossier within the framework of the deliberate release of GMO's (plants or micro-organisms) for experimental purpose (2003) (link on the Belgian Biosafety server) Guidelines for Molecular characterisation of genetically modified higher plants (2003) (link on the Belgian Biosafety server) Guidelines for Genetically Modified Stacked Events to be Placed on the Market (date of document: 23/04/2007)