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Genetically Modified Organisms

Facts and figures

In 2014 >181 million hectares were planted with genetically modified crops worldwide.

In the USA such crops were grown on 73 million hectares (mh). In the EU Spain grew it on 0.5 mh and the Czech Republic, Portugal, Romania, and Slovakia on <0.05 mh.

(ISAAA Brief49-2014: Global Status of Commercialized Biotech/GM Crops)

In 2015 one GMO was authorised to be cultivated in the EU.

As of November 2015 19 EU Member States or parts thereof had demanded geographical restrictions of the scope of authorisations for GMOs.



The regulation of genetically modified organisms (GMOs) has counted among the most politically divisive issues of EU environmental policy for many years. Food containing GMOs, and the cultivation of GMOs, have proven to be highly controversial in many Member States.1 Since 1990, only three GMOs have been authorised for cultivation in the Union, of which only one product (MON810 maize) remained authorised in 2015. Nine Member States also had introduced safeguard clauses preventing the placing on the market and use on their territory of that GMO.2

For a number of years a de facto moratorium applied with respect to the authorisation of GMOs. It essentially consisted of statements from a number of Member

  • 1 See eg Joined cases C-439/05 P and C-454/05 P Land Oberosterreich v Commission and Austria v Commission ECLI:EU:C:2007:510 and ECLI:EU:C:2006:442 and case C-165/08 Commission v Poland ECLI:EU:C:2009:473.
  • 2 Communication from the Commission—Reviewing the decision-making process on genetically modified organisms (GMOs) (22 April 2015) COM(2015) 176 final, 4.

EU Environmental Law and Policy. David Langlet and Said Mahmoudi. © David Langlet and Said Mahmoudi 2016. Published 2016 by Oxford University Press.

States of their intention not to support the approval of any GMOs before the regulatory framework had been changed. This situation led, in 2006, to the EU being found in violation of its obligations under WTO law.[1] Four years later the Commission submitted a proposal to amend the legislation as regards the cultivation of GMOs, which eventually resulted in a significant return of competence to the Member States in 2015. The cultivation of GMOs, which is in fact non-existent in most of the Union, thus constitutes a prime example of an area that has recently undergone (partial) deharmonisation.

The main EU legal framework for GMOs is provided by two directives: Directive 2001/18/EC on the deliberate release into the environment of GMOs,[2] [3] [4] and Directive 2009/41/EC on the contained use of genetically modified micro-organisms.5 Both are recasts of directives from 1990.6 These are complemented by Regulation (EC) No 1946/2003 on transboundary movements of GMOs,[5] Regulation (EC) No 1829/2003 on genetically modified food and feed,[6] and Regulation (EC) No 1830/ 2003 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs.[7]

On the international level GMOs are regulated primarily through the Cartagena Protocol on Biosafety to the Convention on Biological Diversity to which the EU is a Party.[8] It predominantly deals with international shipments of GMOs rather than their cultivation or use.

The focus here is on the main legal framework for the deliberate release into the environment of GMOs, which also includes the placing on the market of such organisms, and to a lesser extent on contained use and export of GMOs. The specific rules that pertain to genetically modified food and feed and labelling requirements are only addressed briefly.

  • [1] EC—Measures Affecting the Approval and Marketing of Biotech Products, Report of the Panel (29 September 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R (‘EC—Biotech Products’).
  • [2] [2001] OJ L 106/1. 5 [2009] OJ L 125/75.
  • [3] 6 Council Directive 90/220/EEC on the deliberate release into the environment of genetically
  • [4] modified organisms [1990] OJ L 117/15, and Council Directive 90/219/EEC on the contained use ofgenetically modified micro-organisms [1990] OJ L 117/1.
  • [5] [2003] OJ L 287/1. 8 [2003] OJ L 268/1. 9 [2003] OJ L 268/24.
  • [6] 10 (Montreal, 29 January 2000) 2226 UNTS 208. The Protocol uses the term ‘living modified
  • [7] organism’ (LMO) rather than GMO. On the definition of LMO see Art 3 of the Protocol. On theCartagena Protocol see further D Langlet Prior Informed Consent and Hazardous Trade: Regulating
  • [8] Trade in Hazardous Goods at the Intersection of Sovereignty, Free Trade and Environmental Protection (2ndedn, Kluwer Law International, 2009) Chap 7.
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