Legislation

Contained use of GMOs

Basic Legislation

• Council Directive 2009/41/EC on the contained use of Genetically Modified Micro-organisms (Recast) lays down measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.

Council Directive 2009/41/EC on the contained use of genetically modified micro-organisms defines contained use as 'any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way and for which specific containment and other protective measures are used to limit their contact with the general population and the environment'.

A genetically modified micro-organism (GMM) is defined as 'a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination'. Again in accordance with the legislation a micro-organism is defined as 'any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture.'

All contained use activities must be assessed as regards the risks they present to human health and the environment. The risk assessment shall result in the classification of the activity into one of four classes (Class 1, Class 2, Class 3 or Class 4 - as appropriate) and in the assignment of containment levels and protective measures. The Risk Assessment procedure is established under Annex III, sections A and B and is supplemented by guidance notes for risk assessment (Commission Decision 2000/608/EC).

Article 3 stipulates that the Directive will not apply to contained uses activities

• where genetic modification is obtained through the use of techniques/methods listed in Annex II Part A, provided they do not entail  the use of recombinant nucleic acid molecules or GMMs

• involving GMMs meeting the criteria listed in Part B of Annex II. These criteria are established in Council Decision 2001/204/EC and are supplemented by guidance notes provided for in Commission Decision 2005/174/EC. The GMMs meeting these criteria (GMMs with a proven and well established history of safe use) shall be listed in Annex II Part C.

Since Directive 2009/41/EC is a minimum standards directive, its scope may be extended to include contained use activities involving Genetically Modified Organisms (GMOs) where an organism is defined as 'any biological entity capable of replication or of transferring genetic material', i.e. GM plants and animals. (The definition of an organism is taken from Directive 2001/18/EC on the deliberate release of GMOs into the environment).

Working group on new techniques

More information can be found here: "New techniques working group"

Implementing measures

Article 17(2) of Directive 2009/41/EC states that 'Every three years and for first time on 5 June 2003, Member States shall send the Commission a summary report on their experience with this Directive ' 

Article 17(3) of Directive 2009/41/EC states that 'Every three years and for first time on 5 June 2004, the Commission shall publish a summary based on the reports referred to in paragraph 2' (i.e. Article 17(2))

1. Summary Report from the Commission based on the reports of Member States concerning their experiences with Directive 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified micro-organisms for the period 1999 – 2003 and Commission staff working paper (Annex to the summary report from the Commission) 
2. Summary Report on the experience of Member States with Directive 90/219/EEC, as amended by Directive 98/81/EC, on the Contained Use of Genetically Modified Micro-organisms for the period 2003 - 2006.

Analysis of the applicability of the contained use legislation for clinical trials (July 2006).

The objective of this study was to examine the extent to which clinical trials are carried out throughout the Community and the legal base used to conduct such trials in Member States.  Different approaches were evident. The legislative basis for Gene Therapy trials differs between the different Member States. Some Member States regulate such trials under the Contained Use Directive (the implementing legislation Directive 90/219/EEC is referenced in the report) while other member states regulate them under the deliberate release directive (Directive 2001/18/EC) while yet other Member States apply their own national legislation.

Checklist for Contained Use Inspections developed by the European Enforcement Project (updated 13th October 2008)