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.
- 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)
- 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.
- Guideline for Part B PCR detection method (PDF)
=> Describes the data to be presented by the notifier in his application dossier on the PCR detection method, and provides information on contact points for further information and reference material disposition.
- Guidelines for Molecular Characterisation of Genetically Modified Higher Plants for a Standard Part B Consent (PDF)