EU Regulatory Framework: Contained use of genetically modified micro-organisms

Jump to: Historical evolution of the European regulatory framework on GMOs

Main elements of Directive 2009/41/EC as compared with the first Directive 90/219/EEC

Classification of GMMs into 4 classes in relation of the risk they present for human health and the environment and categorisation of contained use activities into 4 classes according to purpose and scale;
Administrative procedures and notification requirements directly linked to the risk of the contained use activities involving GMMs (four classes of risk are foreseen);
Streamlined administrative procedures and reduced notification periods;
Possibility for exemptions (under defined criteria) from the Directive of GMMs that are recognised as safe for human health and the environment;
Description in general terms of the elements to be considered to perform risk assessment;
Tables of containment and control measures, to ensure harmonisation and adequate environmental protection;
Increased flexibility for amendment of the technical annexes, allowing timely adaptation to scientific and technical progress;
New rules of comitology for quick adaptation to technical progress: the Commission is assisted by advisory committees if it proves to be necessary to amend not-essential elements of the Directive.

(All the links provided below refer to Eur-lex, the electronic Official Journal of the EU - © European Union)

In the European Union, contained use is defined as “any activity in which micro-organisms are genetically modified or in which such genetically modified micro-organisms (GMMs) are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment”.
Common measures aiming at protecting human health and the environment in case of contained use of GMMs are currently laid down in Directive 2009/41/EC of 6 May 2009. This Directive replaces and repeals Directive 90/219/EEC, bringing together this original Directive and its successive amendments into a single act.

DIRECTIVE 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. (Recast) (OJ L 125, 21.05.2009, p.75)

Every three years the Member States send to the Commission a summary report on their experience with the Directive and the Commission publishes a summary based on these reports. The latest version of this report (covering the period from June 2014 to December 2018) is available on the Eur-lex website

REPORT FROM THE COMMISSION - Experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms for the period 2014 – 2018 (COM/2021/266 final)

Previous EU legislations related to the contained use of GMMs

COUNCIL DIRECTIVE 90/219/EEC of 23 April 1990, on the contained use of genetically modified micro-organisms. (OJ L 117, 8.5.1990, p.1)
COMMISSION DECISION 91/448/EEC of 29 July 1991, concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC. (OJ L 239, 28.8.1991, p.23)
COMMISSION DIRECTIVE 94/51/EC of 7 November 1994, adapting to technical progress Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms. (OJ L 217, 18.11.1994, p.29)
COMMISSION DECISION 96/134/EC of 16 January 1996 amending Decision 91/448/EEC concerning guidelines for classification referred to in Article 4 of Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms. (OJ L 31, 9.2.1996, p.25)
COUNCIL DIRECTIVE 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. (OJ L 330, 5.12.1998, p.13)
COMMISSION DECISION 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms. (OJ L 258, 12.10.2000, p.43)
COUNCIL DECISION 2001/204/EC of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human health and the environment, of types of genetically modified micro-organisms. (OJ L 073, 15.03.2001, p.32)