1 Zurek, Karolina, European Food Regulation after Enlargement: Facing the Challenges of Diversity (Leiden, Boston: Martinus Nijhoff Publishers, 2012) at p. 208.Google Scholar

2 The Council suggested harmonising the Member States’ risk assessment practises, to make better use of expertise and to take full account of the specific regional and local characteristics of the Member States, particularly ecosystems/environments and specific geographical areas of particular value in terms of biodiversity or particular agricultural practices in line with the existing legislation. Council Conclusions on genetically modified organisms, 4 December 2008.

3 Bulgaria, Cyprus, Ireland, Greece, Latvia, Lithuania, Hungary, Luxembourg, Malta, Slovenia, the Netherlands and Poland.

4 Council document n. 11226/2/09 REV 2, available on the Internet at <http://register.consilium.europa.eu/pdf/en/09/st11/st11226-re02.en09.pdf> (last accessed on 18 April 2013).

5 In the present case, the Member States did not request the Commission to repeal the pertinent EU legislation but only to amend it.

6 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of Regions on the freedom for Member States to decide on the cultivation of genetically modified crops, COM (2010) 380 final.

7 OJ 2001 L 106/1.

8 The proposal received the robust support of the European Committee of Regions. Opinion on ‘Freedom for Member States to decide on the cultivation of crops in their territory,’ OJ 2011 C 104/13.

9 See, for example, the emphasis on the need to evaluate the long term environmental effects of GM crops, the emphasis on the precautionary principle, and the liability requirements in case of unintended effects or damage that might occur due to the deliberate release or the placing on the market of GMOs. European Parliament legislative resolution of 5 July 2011 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 (COM(2010)0375 – C7-0178/2010 – 2010/0208(COD)), of 5 July 2011.

10 Report from the Commission on subsidiarity and proportionality, COM (2011) 344.

11 The proposal for a regulation as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory (Council document n. 7153/12, 2 March 2012).

12 Council document n. 10883/1/12, 6 June 2012.

13 OJ 2003 L 268/24.

14 Should a biotech firm request that a GM crop is placed on the market for the exclusive purpose of cultivation, then it will have to follow the authorization procedure of Directive 2001/18; by contrast, Regulation 1829/2003 applies if the purpose of the firm is not only to cultivate the crop but also to sell it on the market as food/feed.

15 See art. 18 of Directive 2002/53 on the common catalogue of varieties of agricultural plant species, OJ 2002 L 193/1.

16 Recital n. 19 states: ‘[…] other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.’

17 Art. 7(1) and 19(1) of Reg. 1829/2003.

18 Opinion of AG Bot in Case C-36/11, Pioneer Hi Bred Italia Srl v Ministero delle Politiche agricole alimentari e forestali, judgment of 26 April 2012, nyr.

19 C-313/11, Commission v Poland, pending.

20 EFSA Journal 2012;10(2):2558.

21 Council document n. 6968/05 of 3 March 2005. In addition to Austria and Hungary, Italy is amongst the countries that has specifically suspended the cultivation of GM maize MON 810 pending the adoption of coexistence measures since 2005. On the management of the Member States’ safeguard measures against specific GMOs. For comments, see Poli, Sara, “Continuity and change in the EU regulatory framework on GMOs after the WTO dispute on ‘biotech products,’” in 37 Legal Issues of Economic Integration (2010), at pp. 139–142.Google Scholar

22 Karolina Zurek, supra note 1.

23 The bans in France and Germany were appealed by Monsanto in both countries. In Germany the request for injunction was rejected; by contrast, in France the highest courts upheld Monsanto’s appeal, yet with no effects on the governmental decision to continue the ban (July 2012).

24 MEMO/10/325 of 13/07/201 availabe at <http://europa.eu/rapid/pressReleasesAction.do?reference=MEMO/10/325>, (last accessed on 18 April 2013).

25 For comments on the reliance on the safeguard measures in 2005, see Javier Guillem Carrau, “Lack of sherpas for a GMO escape route in the EU,? 10 German Law Journal (2009), at pp. 1169– 1200, available at <http://www.germanlawjournal.com/index.php?pageID=11&artID=1153> (last accessed on 18 April 2013) at p. 1189, footnote 60.

26 Kritikos, Michal, “Traditional risk analysis and releases of GMOs into the European Union: space for non-scientific factors,” 34 European Law Review (2009), p. 405 et seqq., at p. 429.Google Scholar

27 Poli, Sara, “Scientific Advice in the GMO Area” in Alberto Alemanno and Simone Gabbi (eds), Foundations of EU Food Law and Policy: 10 Years of European Food Safety Authority (London: Ashgate, forthcoming).Google Scholar

28 For example, EFSA had to re-assess its positive opinions in relation to maize 1507, MON 810 and Bt 11. Indeed, Member States had voiced concerns that the effects on a range of non-target species of Lepidoptera were not appropriately assessed in EFSA's original evaluation. In each case EFSA integrated its original evaluation of the potential impact of GM crops on the Lepidoptera species concerned.

29 See the study commissioned by Greenpeace and Friends of Earth, A critique of the European Food Safety Authority's opinion on genetically modified maize MON810, 2009 available on the Internet at <http://www.greenpeace.at/uploads/media/Critique-on-EFSAMON810.pdf> (last accessed on 18 April 2013).

30 30 EFSA Journal 2012;10(6):2753.

31 The EFSA Journal (2008) 756, 1–18 (Hungary); The EFSA Journal (2008) 891, 1–64 (Austria).

32 EFSA Journal 2012;10(5):2705. It should be noted that the national scientific body set up by the French government concurred with EFSA in raising doubts on the negative environmental effects posed by the GM maize MON 810.

33 Statement on a request from the European Commission for the assessment of the scientific elements supporting the prohibition for the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria, EFSA Journal 2012;10(3):2627.

34 34 T-366/03 and T-235/04 Land of Upper Austria and Republic of Austria v. Commission, [2005] ECR II-4005 and on appeal see C-439/05 P and C-454/05 Land of Upper Austria and Republic of Austria v. Commission, [2007] ECR II-7141.

35 35 T-69/08 Poland v. Commission, [2010] ECR-II 5629.

36 It was excluded that any new interpretation of existing scientific data confirming the safety of a GM crop could justify cultivation bans. For a view that in a situation of scientific uncertainty, these interpretations should be able to justify restrictive measures, see Dobbs, Mary, “Legalising prohibitions on cultivation of genetically modified organisms,” German Law Journa (2010) n. 12, pp. 1354– 1355.Google Scholar

37 C-419/03, Commission v France, [2004] C 228/15; C-121/07 Commission c. France, [2008] ECR II-9159, C-439/05P and 454/05P Land of Upper Austria and Republic of Austria v. Commission, cit, C-165/08 Commission v. Republic of Poland, [2009] ECR I-06843.

38 C- 165/08, supra note n. 37.

39 Par. 51.

40 C- 6/99 Association Greenpeace France and others v. Ministère de l’agriculture et de la pêche and others, [2000] ECR I-1651. In this case the CJEU interpreted Directive 90/220 in the light of the precautionary principle. The CJEU enabled a national authority to refuse its consent to place a GMO on the market if it received new information leading it to believe that the concerned GMO posed risks to human health and the environment. The Court's ruling was transposed in Directive 2001/18, which replaced Directive 90/220.

41 Case C-442/09, Bablok and Others v. Freistaat Bayern, nyr. The CJEU strictly interpreted the authorization and labelling rules on GM food/feed, as provided by Reg. 1829/2003. In this case the Court considered that the presence of GMO material in the end product (honey) was sufficient to require that honey was subject to the authorization procedure of Reg. 1829/2003, regardless of the proportion of genetically modified material contained in the product in question. For a critical comment, see Matthias Lamping, “Shackles for Bees? The CJEU's Judgment on GMO-Contaminated Honey,”1(3) European Journal Risk Regulation (2012), at p. 128.

42 Art. 26b(2).

43 Art. 26b(3).

44 Recital n. 10.

45 The original 2010 Commission proposal did not detail the grounds that could justify restrictive measures. It only provided that these grounds were to be different from those related to the assessment of the adverse effects on health and the environment. An indicative list was prepared in a preparatory document of February 2011. See Commission document n. SEC (2011) 184 of 8 February 2011, p. 3. The Parliament loosely took inspiration from this document. The list of general policy objectives proposed by the Parliament strengthened the environmental reasons and rejected grounds such as public morality, public order or ethics. See Explanatory statement of the report 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 (COM(2010)0375 – C7- 0178/2010 – 2010/0208(COD)) of 20 April 2011.

46 Recital n. 10.

47 For example, the farmers whose crops are affected by this contamination would have to label their products as containing GMOs, thus incurring possible economic damage.

48 Commission Decision n. 2003/653, OJ 2003 L 230/34.

49 Commission Decision n. 2008/62, OJ 2008 L 16/17.

50 Commission Decision n. 2009/828, OJ 2009 L 294/16.

51 By contrast, the Polish challenge in Case T-69/08 (see supra note 35) was upheld on procedural grounds.

52 Hunt, Jo, “Ploughing their own furrow: subnational regions and the regulation of GM crop cultivation,” in Cambridge Yearbook of European Legal Studies, (2010–2011), p. 152.Google Scholar

53 For a recent study on coexistence, see Yves Bertheau, Genetically modified and non genetically modified food supply chains: co–existence and traceability (New York, NY: Wiley, Blackwell, 2012).Google Scholar

54 This expression is borrowed from Jacqueline Peel, “Of Apples and Oranges (and Hormones in Beef): Science and the Standard of Review in WTO Disputes under the SPS Agreement” 61 ICLQ, (2012), at p. 445.

55 T-70/99 Alpharma v. Council of the European Union [2002] ECR II-3495, para. 156 and Case 236/01 Monsanto v. Presidenza del Consiglio de Ministri [2003] ECR I-8105, para. 106.

56 Recital n. 11.

57 Ibid.

58 See Recital n. 10.

59 The environmental problems created by the GM crops would not be ‘unique.’ For a discussion on the difference between the meaning of ‘unique’ and ‘specific’ problems, see AG Sharpston opinion in Joined Cases C-439/05 P and C-454/05 P, Land Oberösterreich and Republic of Austria v Commission, [2007] ECR I-7174, paras. 97–114.

60 Commission Document n. SEC (2011) 184 of 8 February 2011, p. 3.

61 Ibid.

62 Commission Document n. SEC (2011) 184 of 8 February 2011, p. 2.

63 Bernard, Catherine, “Derogations, justifications and the four freedoms: is state interest really protected?” in Bernard, Catherine, Odudu, Okeoghene (eds.), The outer limits of the European Union law (Oxford: Hart publishing, 2009), at p. 299.Google Scholar

64 Indeed, the Commission took the initiative to revisit the authorization regime to cultivate GMOs after requests were made not only by a group of Member States but also by EU citizens. The first attempt to use the European Citizens’ Initiative (art. 24 first indent TFEU), inaugurated by the Lisbon Treaty, was made by a group of people asking the Commission to halt the release of authorizations to cultivate GMOs until a new independent, ethical and scientific body is created to assess their impact, available on the Internet at http://euobserver.com/885/31474 (last accessed on 18 April 2013).

65 The Parliament had proposed to base the draft regulation on art. 192 (1) TFEU dealing with the protection of the environment and had introduced a number of changes in the Commission proposal designed to strengthen the environmental aims of the reform. See European Parliament Legislative Resolution of 5 July 2011, supra note 9.

66 This was recognised by the Commission. See Commission Document n. SEC (2011) 184 of 8 February 2011, p. 2.

67 For an analysis of how the reform of the GMOs cultivation could be defended under the WTO provisions, see Commission Staff Working Paper n. 9648/11, 5 May 2011.

68 By contrast, in the original Commission proposal, art. 26b did not introduce additional rights for Member States to ban the cultivation of GMOs, but merely restated the rights that Member States enjoy to enact trade restrictive measures under articles 34–36 TFEU. Weimer, Maria, “What Price Flexibility? – The Recent Commission Proposal to Allow for National “Opt-Outs” on GMO Cultivation under the Deliberate Release Directive and the Comitology Reform Post-Lisbon,” 3(1) European Journal of Risk Regulation (2010), at p. 350.Google Scholar

69 The Commission describes the decision of a few Member States to regain regulatory autonomy as a sort of “opting out.” COM (2010) 375, p. 6.

70 For a full discussion of the legal basis of the draft regulation, see Commission Document, SEC (2010) 1454 final of 23 November 2010.

71 Commission Document, SEC (2010) 1454 final of 23 November 2010, p. 5.

72 Baram, Michael, “Governance of GM crop and food safety in the United States,” in M. Baram, M. Bourrier, Governing risk in genetically modified agriculture, (Cambridge, Cambridge University Press, 2011), p. 16.Google Scholar See also Bratspies, Rebecca, “The American Approach to Regulating Genetically Modified Organisms,” (2007) Kansas J. L. & Pub. Pol.p. 393.Google Scholar

73 Federal Register of June 26, 1986 (51 FR 23302).

74 Michael Baram, supra note 73, p. 27 and Rebecca Bratspies, “The illusion of care: regulation, uncertainty and genetically modified food crops,” NYU Environmental Law Journal, (2002) p. 310.

75 FDA, Policy statement on foods derived from new plant varieties, section V.A, Federal Register of May 29, 1992 (57 FR 22984).

76 In 1999 the FDA organised public meetings with stakeholders, and, after listening to consumers’ and public interest groups’ views, it decided to change the regulatory system. As of 2001, the FDA requires the submission to the agency of data and information regarding plant-derived bioengineered foods at least 120 days prior to the commercial distribution of such foods. See Premarket Notice Concerning Bioengineered Foods, 2001, Federal Register, 18 January 2001.

77 In particular, the USDA's Animal Plant Health Inspection Service (APHIS) is in charge of the import, shipment, field testing and commercial planting of GM seeds and crops.

78 Bratspies, “The American Approach to Regulating Genetically Modified Organisms”, supra note 72, p. 348.

79 Plant Protection Act, 114 Stat. 438 7 U.S.C. 7701.

80 80 Federal agencies are required “to the fullest extent possible” to prepare an environmental impact statement (EIS) for “every recommendation or report on proposals for legislation and other major Federal actio[n] significantly affecting the quality of the human environment.” 42 U. S. C. §4332(2)(C).

81 In 2006 APHIS decision to permit the cultivation of plant pharmaceutical- producing experimental varieties of corn and sugarcane was challenged before the District Court of Hawaii (Center for Food Safety v. Johanns, 451 F.Supp.2d 1165, D. Haw. Sept. 1, 2006). In February 2007 an APHIS decision to approve field trials was attacked before the District Court of Columbia for failure to adequately assess the potential environmental impacts of genetically engineered grasses (Int’l Ctr. for Tech. Assessment v. Veneman, Docket No. 03-0020, D.D.C. issued Feb. 5, 2007). In February 2007, an APHIS decision to grant deregulated status to the GM alfalfa was challenged before the District Court of California (Geertson Seed Farms v. Johanns, Docket No. 06-1075, N.D. Cal. Feb. 14, 2007).

82 In 2004 the APHIS had issued a permit to plant alfalfa.

83 APHIS complied with the latter requirement and held that the concerned GMO did not create adverse effects on the environment. The EIA showed that the cultivation of this transgenic crop was possible subject to certain risk management measures that could avoid cross-pollination. As a result of this evaluation, APHIS gave the green light to cultivation. The green light was given again for GM alfalfa in the USA, 21 January 2010 available on the Internet at <http://www.gmo-compass.org/eng/news/483.green_light_again_gm_alfalfa_usa.html> (last accessed on 18 April 2013).

84 Monsanto Co et al. v. Geertson Seed Farms et al. certiorari to the United States Court of Appeals for the Ninth Circuit n. 09–475, June 21, 2010. See for a comment Alemanno, Alberto, “The First GMO Case in Front of the US Supreme Court: To Lift or Not to Lift the Alfalfa Planting Ban?”, 2(1) European Journal of Risk Regulation (2010), pp. 152–153.Google Scholar

85 USA: Co-existence – new accents in biotech policy, 7 January 2011, available on the Internet at <http://www.gmo-compass.org/eng/news/483.green_light_again_gm_alfalfa_usa.html> (last accessed on 18 April 2013).

86 Center for Food Safety v. Vilsack, No. C08–00484 JW, 2009, WL 3047227, 21 September 2009. See for a comment A. Platt, “Center for Food Safety v. Vilsak: roundup ready regulations,” Ecology Law Quarterly (2010), p. 773. USA: New court hearings for GM sugar beet, 10 September 2010, available on the Internet at <http://www.gmo-compass.org/eng/news/483.green_light_again_gm_alfalfa_usa.html> (last accessed on 18 April 2013).

87 Platt, “Centre for Food Safety v. Vilsak”, supra note 86, pp. 776–777.

88 Available at <http://www.aphis.usda.gov/biotechnology/news.shtml> (last accessed on 18 April 2013).

89 On 6 November 2012, the citizens of the State of California were called to vote on an initiative statute, known as “Prop 37,” whose objective was to introduce a mandatory labelling scheme for genetically modified food. However, the majority of voters rejected the initiative.