Published online by Cambridge University Press: 06 March 2019
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.
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, 22–31.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