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Schizophrenic Stakes of GMO Regulation in the European Union

Published online by Cambridge University Press:  20 January 2017

Claudio Mereu
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Abstract

EU legislation on genetically modified organisms (GMOs) is the most stringent legislation governing the matter in the world, laying down strict conditions relating to labelling, traceability, threshold and release on the market. In light of a recent Commission proposal to amend Directive 2001/18, which currently regulates the release of GMOs on the European market, this article asks whether and on what basis such stringency is justified. This is done through an in depth analysis of the EU regulatory framework for GMOs while at the same time highlighting the multiple interests at stake (environmental, scientific, industrial, political, national and European).

This article argues that the European institutions should proceed to amend Directive 2001/18 on the basis of a detailed examination of the benefits as well as the risks that GMOs present. This article, however, raises concern that the European regulatory framework will focus exclusively on the risks or on political concerns relating to GMOs instead, for it is a fear of GMOs that seems to permeate the system from top to bottom.

Type
Articles
Information
European Journal of Risk Regulation , Volume 3 , Issue 2 , June 2012 , pp. 202 - 211
Copyright
Copyright © Cambridge University Press 2012

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References

1 WHO, “20 questions on genetically modified foods”, available on the Internet at <http://www.who.int/foodsafety/publications/biotech/20questions/en/> (last accessed on 8 April 2012). Alternatively, the Organisation for Economic Co-operation and Development (“OECD”) defines them as: a “plant or animal micro-organism or virus, which has been genetically engineered or modified.” See OECD, “Agricultural Policies in OECD Countries: Monitoring and Evaluation 2000: Glossary of Agricultural Policy Terms”.

2 Questions and Answers on the Regulation of GMOs in the European Union (“the “EU”) p. 3.

3 WHO Food Safety Department, “Modern food biotechnology, human health and development: an evidence based study”, 1 June 2005, pp. 6–8, available on the Internet at <http://www.who.int/foodsafety/publications/biotech/biotech_en.pdf> (last accessed on 8 April 2012).

4 Ibid.

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6 Stéphanie Mahieu and Paul Nihoul, « La réglementation applicable aux OGM dans l’Union européenne », supra note 5, at p. 193.

7 Note however that opponents of GMOs rely on the same argument to prove risks relating to GMOs.

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13 WHO Food Safety Department, “Modern food biotechnology, human health and development”, supra note 3, pp 11–24.

14 In relation to the environment see the United Nations Convention on Biological Diversity. In relation to food see the Codex Principles and Guidelines for food derived from modern biotechnology, available on the Internet at <http://www.codexalimentarius.net> (last accessed 10 April 2012).

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17 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 of 17 April 2001.

18 European Commission proposal for a Council directive establishing safety measures against conjectural risks associated with recombinant DNA work, OJ C/1978/301/ 5, COM/1978/664/FINAL, available on the Internet at <http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=126700> (last accessed on 10 April 2012).

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20 Morris, Shane H. and Spillane, Charles, “EU GM Crop Regulation: A Road to Resolution or a Regulatory Roundabout?”, 1 European Journal of Risk Regulation (2010), at pp. 359–360 CrossRefGoogle Scholar.

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22 Frantisek Sehnal and Jaroslav Drobník, “White Book Genetically modified crops – EU regulations and research experiences from the Czech Republic”, Biology Centre of the Academy of Sciences of the Czech Republic, 2009, at p. 12, available on the Internet at <http://www.bc.cas.cz/doc/mobitag/White-Book-on-GMO.pdf> (last accessed on 13 April 2012).

23 OECD “Blue Book” on Recombinant DNA Safety Considerations, 1986, available in French on the Internet at <http://www.oecd.org/dataoecd/45/55/1943781.pdf> (last accessed on 13 April 2012).

24 Ibid., p. 44–46. See also Hans Bergmans, “Basic framework for risk assessment of transgenic plants developed by OECD: history and evolution of OECD's risk/safety assessment framework, 20 years ‘Blue Book’, ISBGMO, Jeju Island”, 2007, available on the Internet at <http://www.oecd.org/dataoecd/32/15/37623706.ppt#344> (last accessed on 13 April 2012).

25 Cantley, Mark, “ Life Sciences and GMOs: Still an Uninsurable Risk?”, 29 Geneva Papers on Risk and Insurance: Issues and Practice (2004), p. 493 Google Scholar.

26 EU Commission Communication to the Council entitled A Community framework for the regulation of biotechnology, COM(86) 573.

27 EU Commission Proposal for a Council Directive on the contained use of genetically modified microorganisms and proposal for a Council Directive on the deliberate release to the environment of genetically modified organisms, COM (88)160.

28 Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, OJ 1990 L 117/15 and Council Directive 90/219/EEC on the contained use of genetically modified organisms.

29 See the judgment of the Court of Justice of 21 march 2000, Greenpeace v France, C-6/99, REC. p. I-1676, paragraph 44.

30 Communication from the Commission on the precautionary principle, 2 February 2000, COM (2000) 1, pp. 4–5.

31 See the Directive 90/220/EEC, supra note 28, as amended by the Council Directive 98/81/EC of 26 October 1998, O.J. L 330, 5 December 1998, and particularly the Articles 5,7,11, 15 and 16. See also Oschinsky, Suzanne and Oschinsky, Yves, « Les organismes génétiquement modifiés et le droit », Journal des Tribunaux (2000), pp. 784–785 Google Scholar.

32 de Sadeleer, Nicolas and Noiville, Christine, « Les organismes génétiquement modifiés (O.G.M.) au regard du droit communautaire. Examen critique de la directive 2001/18/C.E.”, Journal des Tribunaux, Droit Européen (2002), at p. 82 Google Scholar.

33 Now Article 114 of the Treaty on the Functioning of the European Union (“TFEU”).

34 Directive 90/220/EEC, supra note 28, article 13.

35 Council Decision 87/373/EEC laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ L 197, 18 July 1987.

36 Department of Environment and Local Government, “Consultation paper on a national policy position on the deliberate release of genetically modified organisms to the environment”, Dublin: Government Stationery Office, 1998, Available on the Internet at <http://www.environ.ie/en/GMO/PublicationsDocuments/FileDownLoad,1312,en.pdf> (last accessed on 13 April 2012).

37 Nicolas de Sadeleer and Christine Noiville, « Les organismes génétiquement modifiés (O.G.M.) au regard du droit communautaire », supra note 32, at p. 82.

38 “Bt” is for “Bacillus thuringiensis”, a toxin inserted in the maize to make it pesticide resistant.

39 Noiville, Christine and Gouyon, Pierre-Henri, “Principe de précaution et organismes génétiquement modifiés. Le cas du maïs transgénique”, in. Kourilsky, Philippe and Viney, Geneviève (eds.), Le principe de précaution (Paris : Odile Jacob/La documentation française, 2000), at pp. 8–10 Google Scholar.

40 Suzanne Oschinsky and Yves Oschinsky, « Les organismes génétiquement modifiés et le droit », supra note 31, at p. 784.

41 Greece, Italy, Luxemburg, France and Denmark.

42 Carrau, Javier Guillem, “ Lack of Sherpas for a GMO Escape Route in the EU – Part I/II”, 10 German Law Journal (2009), pp. 1180–1182 Google Scholar.

43 14 authorisations had been pending since 1998, but not one was granted over this period. Lee, Maria, “ Multi-level governance of GMOs in the EU: ambiguity and hierarchy”, in Cardwell, Michael and Bodiguel, Luc (eds.), The Regulation of GMOs: Comparative Approaches (Oxford: Oxford University Press, 2010), at pp. 2–5 Google Scholar. Available on the Internet at <http://www.cor.europa.eu> (last accessed on 13 April 2012).

44 Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17 April 2001, p. 1.

45 Shane H. Morris and Charles Spillane, “EU GM Crop Regulation”, supra note 20, at p. 362–363.

46 The WTO panel concluded that the moratorium amounted to a breach of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. See WTO dispute settlement, dispute DS291: European Communities, Measures Affecting the Approval and Marketing of Biotech Products, available on the Internet at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds291_e.htm> (last accessed on 13 April 2012) and DS293, available on the Internet at <http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds293_e.htm> (last accessed on 13 April 2012).

47 Dabrowska, Patrycja, “Risk, Precaution and the Internal Market: Who Won the Day in the Recent Monsanto Judgement of ECJ on GM foods”, 5 GERM. L.J. (2004), at p. 151 Google Scholar.

48 See for example case C-419/03 (Court of Justice, C-419/03 of 15 July 2004, Commission of the European Communities against French Republic, OJ C 275 of 15 November 2003), where the Court of Justice held that France had infringed Community law by failing to transpose Directive 2001/18/EC, and case C-121/07 (C-121/07 of 9 December 2008, Commission of the European Communities v French Republic, OJ C 95, 28 April 2007) in which France was condemned for failing to comply with the previous judgment.

49 Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ L 184, 17 July 1999, p. 23.

50 Article 1 of Directive 2001/18, supra note 44.

51 Articles 9 and 24, ibid.

52 Nicolas de Sadeleer and Christine Noiville, « Les organismes génétiquement modifiés (O.G.M.) au regard du droit communautaire », supra note 32, pp. 82–84.

53 Questions and Answers on the Regulation of GMOs in the European Union, MEMO/05/104, 22 March 2005, pp. 10–13.

54 EFSA recently published a guidance for risk assessment of food and feed from genetically modified plants (EFSA Journal 2011; 9(5): 2150) available on the Internet at <http://www.efsa.europa.eu/en/efsajournal/doc/2150.pdf> (last accessed on 13 April 2012).

55 Article 6 of Regulation 1829/2003/EC, supra note 16.

56 In accordance with a regulatory committee procedure (Article 5 of Council Decision 1999/468/EC of 28 June 1999, supra note 49).

57 Regulation 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 of 18 October 2003.

58 Article 3 of Regulation 1830/2003, supra note 16.

59 Article 4 A, ibid.

60 Stéphanie Mahieu and Paul Nihoul, « La réglementation applicable aux OGM dans l’Union européenne », supra note 5, at p. 197.

61 Article 4 B of Regulation 1830/2003, supra note 57.

62 Article 24 of Regulation 1829/2003, supra note 16, and Article 7 of Regulation 1830/2003, supra note 57.

63 Case C-442/09, Karl Heinz Bablok and Others v Freistaat Bayern [2011], 6 September 2011.

64 Commission Recommendation of 23 July 2003 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops, C(2003).

65 See for example Javier Guillem Carrau, “Lack of Sherpas for a GMO Escape Route in the EU”, supra note 42, at p. 1196; Davison, John, “ GM Plants: science, politics and EC regulations: a review”, 178 Plant Science (2010), at pp. 96–97 CrossRefGoogle Scholar.

66 Shane H. Morris and Charles Spillane, “EU GM Crop Regulation: A Road to Resolution or a Regulatory Roundabout?”, supra note 20, at pp. 364–365; John Davison, “GM Plants”, supra note 65, at pp. 96–97.

67 Commission proposal of 13 July 2010 for a regulation of the European Parliament and of the Council amending Directive 2001/18/ EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory, C(2010) 380 final, C(2010) 4822 final.

68 For instance according to the latest Eurobarometer survey on this issue published in October 2010, 61% of Europeans consider that GM food makes them feel uneasy and the same proportion disagree with the idea that the development of GM food should be encouraged; 23% agree with the idea that ‘GM food does no harm to the environment,’ in contrast with 53% who disagree with this statement and the remainder who ‘don’t know’; finally, in no Member State was there a majority who agreed with the statement that GM food is good for the national economy.

69 Article 1, ibid.

70 According to the Commission, a regulation is more appropriate because “the proposal has general application, is binding in its entirety and is directly applicable in all Member States. In addition, (the proposal) does not contain in substance any provision that would require transposition as it only provides to the Member States a legal base to adopt measures”, ibid., p. 8.

71 Draft report of the 27 january 2011on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory (COM(2010)0375 – C7-0178/2010 – 2010/0208(COD)). Committee on the Environment, Public Health and Food Safety. Rapporteur: Corinne Lepage, 2010/0208(COD).

72 Article 193 of TFEU.

73 See case law including Case C-491/01 of 10 December 2002, British American tobacco, European Court reports 2002 Page I-11453, in particular paragraph 94: “If examination of a Community act shows that it has a twofold purpose or twofold component and if one of these is identifiable as main or predominant, whereas the other is merely incidental, the act must be founded on a sole legal basis, that is, the one required by the main or predominant purpose or component. Exceptionally, if it is established that the act simultaneously pursues a number of objectives, indissociably linked, without one being secondary and indirect in relation to the other, such an act may be founded on the various corresponding legal bases (Opinion 2/00 [2001] ECR I-9713, paragraph 23)”.

74 Opinion of 15 March 2011 of the Committee on Agriculture and Rural Development for the Committee on the Environment, Public Health and Food Safety on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of GMOs in their territory (COM(2010)0375 – C7-0178/2010 – 2010/0208(COD)) Rapporteur: George Lyon, 2010/0208(COD), p. 3.

75 Ibid., Amendment 6, pp. 9–10.

76 Compromise amendments 1–17 of 8 April 2011, Draft Report by Corinne Lepage on the proposal for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory (PE456.911v01-00), PE460.969v01-00.

77 Ibid., amendments 5 and 11.

78 Ibid., amendment 3.

79 “Such lack of stability could lead to incomplete research programs, cancelled EU funded projects, flight of capital and scientific knowledge from the EU, and employment uncertainty within the plant science research community making the EU an unattractive research and development location for the agri-food sector”. Shane H. Morris and Charles Spillane, “EU GM Crop Regulation: A Road to Resolution or a Regulatory Roundabout?”, supra note 20, at pp. 365–366.