Environmental release of GMOs for experimental purpose: Tools for risk assessment and risk management

For the preparation of the notification dossiers by the applicants and their assessment by the advisory bodies and experts, a (non-exhaustive) list of useful guidelines developed by official bodies (and applicable to higher plants and/or other (micro-)organisms) is listed below.

EU documents

  • Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC (OJ L 200, 30.7.2002, p. 22, Link to the Eur-Lex website)
    => Guidance on the objective, elements, general principles and methodology of the environmental risk assessment referred to in the Directive.
  • Commission Directive (EU) 2018/350​ of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms (OJ L 67, 9.3.2018, p. 30)

OECD documents

  • Consensus Documents developed by the Working Group on Harmonisation of Regulatory Oversight in Biotechnology (Link to the OECD website)
    => Documents focusing on the biology of organisms (such as plants, trees or micro-organisms) or introduced novel traits and comprising technical information for use during the regulatory assessment of products of biotechnology.

Belgian documents