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GM Foods, Risk, Precaution and the Internal Market: Did Both Sides Win the Day in the recent Judgment of the European Court of Justice?

Published online by Cambridge University Press:  06 March 2019

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Almost exactly one year after the famous judgments of the Court of First Instance on the precautionary principle, the European Court of Justice (hereinafter “the Court”) has issued a preliminary ruling further exploring this concept. The ruling arose from a national dispute concerning a temporary ban on novel foods produced from genetically modified organisms (hereinafter “GMOs”). This recent Monsanto judgment is the first case in which the Court has directly invoked the precautionary principle regarding Member States’ power to adopt a provisional prohibition on the marketing of GMO-derived novel foods. Simultaneously, the Court lent an ear to the arguments of Monsanto by declaring the validity of the simplified procedure laid down in the novel foods Regulation 258/97 and based on the contentious concept of substantial equivalence. Thus, it seems to have favoured the free circulation in the Community market of novel foodstuffs notwithstanding the presence of residues of genetically modified (hereinafter “GM”) protein, on the condition that there is no risk to human health.

Type
European & International Law
Copyright
Copyright © 2004 by German Law Journal GbR 

References

1 Case T-13/99 Pfizer Animal Health S.A. v. Council 2002 ECR II-3305 (hereinafter Pfizer); case T-70/99 Alpharma Inc. v. Council 2002 ECR. Cf. also Olivier Segnana, The Precautionary Principle: New Developments in the Case Law of the Court of First Instance, Vol. 3 German Law Journal (GLJ) No. 10 (1 October 2002); Caoimhín MacMaoláin, Using the precautionary principle to protect human health: Pfizer v Council, 28 European Law Review (ELRev.) 723 (2003).Google Scholar

2 Judgment of the Court of 9 September 2003 case C-236/01 Monsanto Agricoltura Italiana SpA and Others v. Presidenza del Consiglio dei Ministri and Others, nyr in the ECR, available at http://curia.eu.int (hereinafter Monsanto case).Google Scholar

3 Cf. however a similar case concerning GM maize and the Directive 90/220 on GMO Deliberate Releases C-6/99 Association Greenpeace France and Others v Ministere d l'Agriculture et de la Peche and Others,2000 ECR I-1651 (hereinafter Greenpeace case).Google Scholar

4 Monsanto, para. 84, 110 and 133.Google Scholar

5 Art. 1-3 EC Regulation 258/97 (hereinafter “Regulation 258/97”) on novel foods and novel food ingredients O.J. 1997 L 43/1 as amended by EC Regulation 1829/2003 on genetically modified food and feed O.J. 2003 L 268/1. The latter act replaces Regulation 258/97 with respect to GM food (their authorizations and labelling).Google Scholar

6 Art 5, Regulation 258/97.Google Scholar

7 Bt-11, MON 9 and MON 10 GM maize lines with the increased resistance to pests and tolerance to herbicides.Google Scholar

8 Monsanto (note 2), para. 18.Google Scholar

9 For the critique of this concept cf. inter alia Melanie Steiner, Food Fight – the Changing landscape of Genetically Modified Foods and the Law, 9 (2) Review of European Community and International Environmental Law (RECIEL) 152, 156 (2000).Google Scholar

10 The Standing Committee on Foodstuffs, composed of representatives of the Member States, was set up under the Council Decision 69/414/EEC of 13 November 1969, O.J. 1969 (II) p. 500, cf. infra 14. On the Commission committees see generally Ellen Vos, Institutional Frameworks of Community Health and Safety Regulation: Committees Agencies and Private Bodies (1999).Google Scholar

11 Monsanto (note 2) – Opinion of AG Alber - hereinafter “AG Opinion”, para. 24.Google Scholar

12 Decree of the President of the Council of Ministers of 4 August 2000 on the precautionary suspension of the trade and use of certain transgenic products within national territory under Art 12 of Regulation 258/97 (GURI No. 184 of 8 August 2000, p. 9), see Monsanto (note 2), para. 16, 2231.Google Scholar

13 Art. 12, Regulation 258/97.Google Scholar

14 The Scientific Committee on Food was set up under the Commission Decision 74/234/EEC of 16 April 1974, O.J. 1974 L 136/1. Under EC Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, O.J. 2002 L 31/1, both committees the Scientific Committee on Food and the Standing Committee on Foodstuffs were partly replaced or renamed.Google Scholar

15 Opinion concerning a submission from the Italian authorities raising concerns for the safety of certain products approved under the notification procedure of Regulation (EC) 258/97, expressed on 7 September 2000, CS/NF/DOS/11 ADD 4 REV 2 Final, available at http://europa.eu.int.Google Scholar

16 Monsanto (note 2), para. 35-37. It is worth noting that the simplified procedure was abandoned in relation to GM foodstuffs by the new EC Regulation 1829/2003 on genetically modified food and feed, supra note 5.Google Scholar

17 Official Minutes of the Environmental Council of the EU, 24-25 July 1999, 9433/1/99 REV 1, annex II 14; see also Hervey, Tamara, Regulation of Genetically Modified Products in a Multi-Level System of Governance: Science or Citizens?, 10 (3) RECIEL 321 (2001).Google Scholar

18 Cf. Monsanto (note 2), para. 40, 50 and 86.Google Scholar

19 Monsanto (note 2), para. 41-48.Google Scholar

20 Id., para. 74, 106 and 136.Google Scholar

21 Cf. Art. 1.2 (b) and 3.4, Regulation 258/97.Google Scholar

22 Monsanto (note 2), para. 72-74.Google Scholar

23 Id., para. 77, 79 and 129Google Scholar

24 Id., para. 79.Google Scholar

25 Id., para. 70-71and 130.Google Scholar

26 Unfortunately, the Court did not conduct an analysis of the second method for establishing the substantial equivalence of foods, which is provided by Regulation 258/97, namely when it is based upon available and generally recognized scientific evidence. The use of this method could, in theory, enable by-passing of the involvement of any scientific body before novel foods are marketed. This issue was raised by Advocate General in his opinion, cf., AG Opinion, para. 86-87.Google Scholar

27 Monsanto (note 2), para. 81, 84 and 137.Google Scholar

28 Id., para. 77 and 82.Google Scholar

29 Id., para. 84, 99 and 126.Google Scholar

30 Monsanto (note 2) AG Opinion, para. 51.Google Scholar

31 Monsanto (note 2), para. 80.Google Scholar

32 Id., para. 130-132.Google Scholar

33 Id., para. 133, see also section III below.Google Scholar

34 Id., para. 47, 136-138 .Google Scholar

35 Cf. Ellen Vos, Differentiation, Harmonization and Governance in The many faces of differentiation in EU law, 162, 167 (de Witte, Bruno, Hanf, Dominik, Vos, Ellen eds., 2001); and in the similar context Patrycja Dąbrowska, The division of powers between the EU and the Member States with regard to deliberate release of GMOs (the new Directive 2001/18), 3 GLJ No. 5 (1 May 2002).Google Scholar

36 Article 12.1, Regulation 258/97 is worded as follows: „Where a Member State, as a result of new information or reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision“Google Scholar

Even though the text of the Regulation mentions the dangers, both, to human health and the environment, the Court in its analysis concentrated mainly on the first one “risk to public health”.Google Scholar

37 Monsanto (note 2), para. 100.Google Scholar

38 Id., para. 104.Google Scholar

39 Id., para. 102-103.Google Scholar

40 Id., para. 105-106. Already confirmed in case C-192/01, Commission v. Denmark, judgment of 23 September 2003, nyr, para. 49-51 (hereinafter Danish nutrients case).Google Scholar

41 Id., para. 107.Google Scholar

42 Id., para. 106Google Scholar

43 Id., para. 108-109, Art. 12, Regulation 258/97.Google Scholar

44 Id., para. 110.Google Scholar

45 Id., para. 133.Google Scholar

46 Id., para. 111-112; and inter alia, Pfizer para. 139; case C-157/96, National Framers’ Union and Others, 1998 ECR I-2211, para. 63; C-180/96 United Kingdom v. Commission 1998 ECR I-2265, para. 99. Cf. also Joanne Scott, Precautionary Principle before the European Courts, (forthcoming).Google Scholar

47 Id., para. 112; see also Pfizer para. 162.Google Scholar

48 Id., para. 113.Google Scholar

49 See supra, note 45.Google Scholar

50 Cf. also Segnana (note 1).Google Scholar

51 Monsanto (note 2), AG Opinion, para. 56-57, 84-88.Google Scholar

52 Monsanto (note 2), para. 114.Google Scholar

53 Id., para. 79; see also Principles for the Risk Analysis of Foods Derived from Modern Biotechnology adopted at the Twenty-Sixth Session of the Codex Alimentarius Commission, 30 June – 7 July 2003, available at http://codexalimentarius.net.Google Scholar

54 Cf. Art. 3 (4), Regulation 258/97. This point was raised by Advocate General in his opinion, para. 86-87.Google Scholar

55 Cf. the earlier findings of the Court of First Instance with regard to the Community institutions, Pfizer, para. 162. See also MacMaoláin (note 1), 726.Google Scholar

56 Danish nutrients (note 39), where the Monsanto case is cited, para. 49, 56.Google Scholar

57 Cf. MacMaoláin (note 1), 729.Google Scholar

58 It did so in the Greenpeace ruling for what it was criticized as being too laconic, see Mastromatteo, Andrea, A lost opportunity for European Regulation of genetically modified organisms, 25 ELRev. 2000, 425.Google Scholar

59 Scott (note 45).Google Scholar

60 Cf. MacMaoláin (note 1), 729.Google Scholar

61 Cf. for example Pfizer, para. 456, 471.Google Scholar

62 Cf. MacMaoláin (note 1), 727 and Pfizer, para. 150-153, 162.Google Scholar

63 Cf. generally Grainne de Burca, Proportionality and Subsidiarity as General Principles of Law, in The General principles of EC Law (Bernitz, Ulf, Nergelius, Joakim eds. 2000).Google Scholar

64 Cf. Danish nutrients (note 39), para. 53.Google Scholar

65 See supra (note 5), Monsanto (note 2), para. 65-68.Google Scholar

66 Cf. EU split over controversial GMO authorisation, EUobserver 8 December 2003, at: www.euobserver.com.Google Scholar

67 Cf. Vos (note 35), 169.Google Scholar

68 Monsanto (note 2), para. 71, 84, 99 and 126; Art.Google Scholar

69 Monsanto (note 2), AG Opinion, para. 135 and 150, cf. Art. 3 (4), Regulation 258/97.Google Scholar

70 Cf. EU postpones controversial GM decision, EUobserver 10 November 2003, at: www.euobserver.com.Google Scholar