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

German Law Journal

Volumn 5, Issue 2, 2004, Pages 151-166

  Dąbrowska, Patrycja ^a  

^a NONE

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EID: 27144543472     PISSN: None     EISSN: 20718322     Source Type: Journal    
DOI: 10.1017/S2071832200012335     Document Type: Article

References (71)

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);
2. Caoimhín MacMaoláin, Using the precautionary principle to protect human health: Pfizer v Council, 28 Euro-pean Law Review (ELRev.) 723 (2003).
3. 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 (herein-after Monsanto case).
4. 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).
5. Monsanto, para. 84, 110 and 133.
6. Art. 1-3 EC Regulation 258/97 (hereinafter “Regulation 258/97") on novel foods and novel food ingre-dients 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 authoriza-tions and labelling).
7. Art 5, Regulation 258/97.
8. Bt-11, MON 9 and MON 10 GM maize lines with the increased resistance to pests and tolerance to herbicides.
9. Monsanto (note 2), para. 18s.
10. For the critique of this concept cf. inter alia Melanie Steiner, Food Fight - the Changing landscape of Geneti-cally Modified Foods and the Law, 9 (2) Review of European Community and International Environmental Law (RECIEL) 152, 156 (2000).
11. 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).
12. Monsanto (note 2) - Opinion of AG Alber - hereinafter “AG Opinion”, para. 24.
13. 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.
14. Art. 12, Regulation 258/97.
15. 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 re-quirements 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.
16. 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 Septem-ber 2000, CS/NF/DOS/11 ADD 4 REV 2 Final, available at http://europa.eu.int.
17. 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.
18. Official Minutes of the Environmental Council of the EU, 24-25 July 1999, 9433/1/99 REV 1, annex II 14; see also Tamara Hervey, Regulation of Genetically Modified Products in a Multi-Level System of Govern-ance: Science or Citizens?, 10 (3) RECIEL 321 (2001).
19. Cf. Monsanto (note 2), para. 40, 50 and 86.
20. Monsanto (note 2), para. 41-48.
21. Monsanto (note 2)., para. 74, 106 and 136.
22. Cf. Art. 1.2 (b) and 3.4, Regulation 258/97.
23. Monsanto (note 2), para. 72-74.
24. Monsanto (note 2)., para. 77, 79 and 129
25. Monsanto (note 2)., para. 79.
26. Monsanto (note 2)., para. 70-71and 130.
27. Unfortunately, the Court did not conduct an analysis of the second method for establishing the sub-stantial 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.
28. Monsanto (note 2), para. 81, 84 and 137.
29. Monsanto (note 2)., para. 77 and 82.
30. Monsanto (note 2)., para. 84, 99 and 126.
31. Monsanto (note 2) AG Opinion, para. 51.
32. Monsanto (note 2), para. 80.
33. Monsanto (note 2)., para. 130-132.
34. Monsanto (note 2)., para. 133, see also section III below.
35. Monsanto (note 2)., para. 47, 136-138.
36. Cf. Ellen Vos, Differentiation, Harmonization and Governance in The many faces of differentiation in EU law, 162, 167 (Bruno de Witte, Dominik Hanf, Ellen Vos eds., 2001);
37. Patrycja Dąb-rowska, 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).
38. Article 12.1, Regulation 258/97 is worded as follows: “Where a Member State, as a result of new in-formation 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.” Even though the text of the Regulation mentions the dangers, both, to human health and the environ-ment, the Court in its analysis concentrated mainly on the first one “risk to public health”.
39. Monsanto (note 2), para. 100.
40. Monsanto (note 2)., para. 104.
41. Monsanto (note 2)., para. 102-103.
42. Monsanto (note 2)., para. 105-106. Already confirmed in case C-192/01, Commission v. Denmark, judgment of 23 Sep-tember 2003, nyr, para. 49-51 (hereinafter Danish nutrients case).
43. Monsanto (note 2)., para. 107.
44. Monsanto (note 2)., para. 106
45. Monsanto (note 2)., para. 108-109, Art. 12, Regulation 258/97.
46. Monsanto (note 2)., para. 110.
47. Monsanto (note 2)., para. 133.
48. Monsanto (note 2)., 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).
49. Monsanto (note 2)., para. 112; see also Pfizer para. 162.
50. Monsanto (note 2)., para. 113.
51. Cf. also Segnana (note 1).
52. Monsanto (note 2), AG Opinion, para. 56-57, 84-88.
53. Monsanto (note 2), para. 114.
54. 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.
55. Cf. Art. 3 (4), Regulation 258/97. This point was raised by Advocate General in his opinion, para. 86-87.
56. 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.
57. Danish nutrients (note 39), where the Monsanto case is cited, para. 49, 56.
58. Cf. MacMaoláin (note 1), 729.
59. It did so in the Greenpeace ruling for what it was criticized as being too laconic, see Andrea Mastromat-teo, A lost opportunity for European Regulation of genetically modified organisms, 25 ELRev. 2000, 425.
60. Scott (note 45).
61. Cf. MacMaoláin (note 1), 729.
62. Cf. for example Pfizer, para. 456, 471.
63. Cf. MacMaoláin (note 1), 727 and Pfizer, para. 150-153, 162.
64. Cf. generally Grainne de Burca, Proportionality and Subsidiarity as General Principles of Law, in The Gen-eral principles of EC Law (Ulf Bernitz, Joakim Nergelius eds. 2000).
65. Cf. Danish nutrients (note 39), para. 53.
66. See supra (note 5), Monsanto (note 2), para. 65-68.
67. Cf. EU split over controversial GMO authorisation, EUobserver 8 December 2003, at: www.euobserver.com.
68. Cf. Vos (note 35), 169.
69. Monsanto (note 2), para. 71, 84, 99 and 126; Art.
70. Monsanto (note 2), AG Opinion, para. 135 and 150, cf. Art. 3 (4), Regulation 258/97.
71. Cf. EU postpones controversial GM decision, EUobserver 10 November 2003, at: www.euobserver.com.