EU regulatory framework: Deliberat​e Release of GMOs

(All the links provided below refer to Eur-lex, the electronic Official Journal of the EU - © European Union, 1998-2016)

The EU has adopted a comprehensive legislative framework for the deliberate release and placing on the market of GMOs. Directive 2001/18/EC is the text of reference. It defines a common methodology to assess case-by-case the risks for the environment associated with the release of GMOs, and common objectives for the monitoring of GMOs after their deliberate release or placing on the market. The Directive establishes the procedural requirements for R&D trials involving environmental release of GMOs, and for the commercialisation of GMOs. However, GMOs destined for food or feed, and medicinal GMOs for human or veterinary use are subject to specific legal provisions, defined in Regulation (EC) No 1829/2003 and Regulation (EC) No 726/2004 ​respectively.

  • DIRECTIVE 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. (OJ L 106, 17.4.2001, p. 1)

The Directive has been amended several times since its publication in 2001:

=> In 2018 to update the annexes as regards the environmental risk assessment with a view to incorporating and building upon the Guidance published by EFSA, and in order to adapt to technical progress and taking into account the experience gained in the environmental risk assessment of genetically modified plants.

  • 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)

=> In 2015 to allow Member States to restrict or ban GMO cultivation in their territory.

  • DIRECTIVE (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory. (OJ L 68, 13.3.2015, p. 1)

=> In 2003 to establish legal provisions for ensuring the traceability of GMOs throughout the food and feed chains. These rules apply to all products which consist of GMOs or which contain them, and to foodstuffs and animal feed products made from GMOs (including in processed foods in which the production methods have destroyed or altered the genetically modified DNA, e.g. in oils).

  • REGULATION (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. (OJ L 268, 18.10.2003, p. 24)

Building on the work performed in the Organisation for Economic Cooperation and Development (OECD), the EU has adopted in 2004 a system for the development and assignment of unique identifiers (UIs) for GMOs. UIs consist in a code that is specific to each GMO, made up of letters and numbers, enabling each product type to be identified precisely. It contributes to the traceability of GMOs.

  • COMMISSION REGULATION (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms. (OJ L 10, 16.1.2004, p. 5)

In addition, a number of implementing measures have been adopted over the years to support operation of Directive 2001/18/EC, with regards to information gathering and dissemination, the summary notification format (SNIF), explanatory notes on the annexes and the implementing powers conferred on the Commission. 

  • 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)
  • COUNCIL DECISION 2002/811/EC of 3 October 2002 establishing guidance notes supplementing Annex VII 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 280, 18.10.2002, p. 27) 
  • COUNCIL DECISION 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products. (OJ L 280, 18.10.2002, p. 37)
  • COUNCIL DECISION 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market. (OJ L 280, 18.10.2002, p. 62)
  • COMMISSION DECISION 2003/701/EC of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market. (OJ L 254, 8.10.2003, p. 21) 
  • COMMISSION DECISION 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council. (OJ L 65, 3.3.2004, p. 20)
  • DIRECTIVE 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission. (OJ L 81, 20.3.2008, p. 45)

Previous EU legislation related to the deliberate release of GMOs

  • COUNCIL DIRECTIVE 90/220/EEC of 23 April 1990, on the deliberate release into the environment of genetically modified organisms. (OJ L 117, 8.5.1990, p.15)
  • COMMISSION DECISION 91/274/EEC of 21 May 1991 concerning a list of Community legislation referred to in Article 10 of Council Directive 90/220/EEC. (OJ L 135, 30.5.1991, p.56)
  • COUNCIL DECISION 91/596/EEC of 4 November 1991, concerning the Summary Notification Information Format referred to in Article 9 of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. (OJ L 322, 23.11.1991, p.1)
  • COMMISSION DECISION 92/146/EEC of 11 February 1992, concerning the Summary Notification Information Format referred to in Article 12 of Council Directive 90/220/EEC. (OJ L 60, 5.3.1992, p.19)
  • COMMISSION DECISION 93/584/EEC of 22 October 1993, establishing the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6 (5) of Council Directive 90/220/EEC. (OJ L 279, 12.11.1993, p.42)
  • COMMISSION DIRECTIVE 94/15/EC of 15 April 1994, adapting to technical progress for the first time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. (OJ L 103, 22.4.1994, p.20)
  • COMMISSION DECISION 94/211/EC of 15 April 1994, amending Council Decision 91/596/EEC concerning the Summary Notification Information Format referred to in Article 9 of Council Directive 90/220/EEC. (OJ L 105, 26.4.1994, p.26)
  • COMMISSION DECISION 94/730/EC of 4 November 1994, establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6 (5) of Council Directive 90/220/EEC. (OJ L 292, 12.11.1994, p.31)
  • COMMISSION DIRECTIVE 97/35/EC of 18 June 1997, adapting to technical progress for the second time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. (OJ L 169, 27.6.1997, p.72)