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Divided in Diversity: Reforming The EU’s GMO Regime

Published online by Cambridge University Press:  21 January 2016

Miranda GEELHOED
Miranda GEELHOED*
Affiliation:
School of Law, University of Edinburgh
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Abstract

This article analyses the recent reform to the EU’s genetically modified organisms (GMO) regime which allows Member States to restrict the cultivation of GMO on their territory for reasons that do not relate to issues of health and safety or the environment. By allowing for national differentiation – although on legally questionable grounds – new Article 26b of Directive 2001/18/EC has been presented as a solution to overcome the impasse in GMO decision-making. However, this article finds that the reform fails to provide a solution for the EU regime’s most pressing problem, namely its disregard for scientific uncertainty and disagreement.

Keywords

GMOcultivationrisk regulationWTOinternal marketopt-outsEFSA
Type
Articles
Information
Cambridge Yearbook of European Legal Studies , Volume 18 , December 2016 , pp. 20 - 44
Copyright
© Centre for European Legal Studies, Faculty of Law, University of Cambridge 

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Footnotes

*

I would like to thank Dr Apolline Roger for her thoughtful comments. All remaining errors are my own.

References

1 Directive (EU) 2015/412 [2015] OJ L68/1.

2 EP Resolution of 16 January 2014 on Placing on the Market for Cultivation of a Genetically Modified Maize Product (2013/2974) P7_TA(2014)0036.

3 Austrian National Council, Rahmengesetz für Gentechnik-Anbauverbot, 673 dB (July 2015) http://www.parlament.gv.at/PAKT/VHG/XXV/I/I_00673/index.shtml [last accessed 30 November 2015]; Hungarian Ministry of Agriculture, Hungary could be first in EU to introduce new GMO regulations (11 May 2015) http://www.kormany.hu/en/ministry-of-agriculture/news/hungary-could-be-first-in-eu-to-introduce-new-gmo-regulations [last accessed 30 November 2015].

4 Whereas Germany seeks to opt – if legally feasible – for nationwide cultivation bans, (German Federal Ministry of Agriculture, Anbauverbot von Gentechnikpflanzen in Deutschland (1 September 2015) https://www.bmel.de/DE/Landwirtschaft/Pflanzenbau/Gentechnik/_Texte/NatRegelungAnbauverbote.html [last accessed 30 November 2015], the UK is likely to opt for more diversified, regional strategies as exemplified by its recent opt-out request under Art 26c(1) Directive 2015/412, ‘15 Member States Opt Out of GMO Culture’ (Euractiv, 2 October 2015) http://www.euractiv.com/sections/agriculture-food/15-member-states-opt-out-gmo-culture-318181 [last accessed 30 November 2015].

5 The other crops are the MON810 Maize, Commission Decision (EC) 98/294 [1998] OJ L 131/32, and the annulled authorisation for the Amflora Potato, Commission Decision (EU) 2010/135 [2010] OJ L53/11.

6 Commission, Fact Sheet: Questions and Answers on EU’s policies on GMOs (22 April 2015) MEMO/15/4778.

7 On the risks and benefits of GMOs, see MA Pollack and GC Schaffer, When Cooperation Fails: The International Law and Politics of Genetically Modified Foods (Oxford University Press, 2009), ch 2.

8 Art 13 Directive (EEC) 90/220 [1990] OJ L117/15.

9 Lee, M, EU Regulation of GMOs: Law and Decision Making for a New Technology (Edward Elgar Publishing, 2008), p 66 CrossRefGoogle Scholar.

10 WTO Dispute Settlement, European Communities — Measures Affecting the Approval and Marketing of Biotech Products, Reports of the Panel (29 September 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R; Skogstad, G, ‘Contested Accountability Claims and GMO Regulation in the European Union’ (2011) 49 (4) Journal of Common Market Studies 895 CrossRefGoogle Scholar.

11 Directive (EC) 2001/18 [2001] OJ L106/1; Regulation (EC) 1829/2003 [2003] OJ L268/1.

12 Recs 6–7 Directive 2015/412.

13 European Commission, Proposal for a Regulation regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory’ COM(2015) 177; see also Commission, Reviewing the decision-making process on genetically modified organisms (GMOs) COM(2015) 176.

14 Art 2(2) TFEU, last sentence. See however Poli, S, ‘The Member States’ Long and Winding Road to Partial Regulatory Autonomy in Cultivating Genetically Modified Crops in the EU’ (2013) 4 (2) European Journal of Risk Regulation 143 CrossRefGoogle Scholar, p 153 who argues that the provided conditional and partial re-nationalisation could not be based upon this.

15 ‘EU Governments Seen Opposing GM Crop Proposals’ (Euractiv, 30 July 2010) http://www.euractiv.com/cap/eu-governments-seen-opposing-gm-news-496823 [last accessed August 2015].

16 European Commission Recommendation (EU) [2010] OJ C200/1, providing guidelines for the development of national coexistence measures, is non-binding although the Amendment to Art 26a (Directive 2015/412) does require Member States to adopt measures in border areas as of 3 April 2017, following suggestions by European Parliament ENVI Committee, Recommendations for Second Reading A8-0038/2014, Amendments 9 and 34. Possibilities for redress depend on the applicable, national liability standards or on the application of Directive (EC) 2004/35 [2004] OJ L143/56 on environmental liability, which gives no financial guarantees (see contrarily ENVI Recommendations above: Amendment 44).

17 European Commission, Explanatory Memorandum COM(2010) 375, p 2.

18 Rec 32 and Art 4(1) Directive 2001/18/EC; Art 4(2) Regulation 1829/2003.

19 Art 1 Directive 2001/18/EC; note 5 above (Amflora Decision).

20 Art 3 Regulation 1829/2003.

21 Art 17(5) Regulation 1829/2003 and Annexes II and VII Directive 2001/18/EC.

22 Art 28 Directive 2001/18/EC and Regulation (EC) 178/2002 [2002] OJ L 31/1 establishing EFSA.

23 Art 5(1)(2) and 17(1)(2) Regulation 1829/2003; Lee note 9 above, p 66.

24 Arts 18(6) and 19(1) Regulation 1829/2003; Art 28 Directive 2001/18/EC.

25 Arts 3 and 5 Regulation (EU) 182/2011 [2011] OJ L55/13 and Art 35(1) Regulation 1829/2003. Under Directive 2001/18/EC the Commission is assisted by a Regulatory Committee (Art 30).

26 On the voting behaviour of SCFAH members Klika, C et al, ‘Why Science Cannot Tame Politics: The New EU Comitology Rules and the Centralised Authorisation Procedure of GMOs’ (2013) 4(3) European Journal of Risk Regulation 327, p 330 CrossRefGoogle Scholar.

27 Art 6 Regulation 182/2011.

28 For empirical evidence see Klika et al note 26 above, p 332; for a theoretical perspective see Paskalev, V, ‘Can Science Tame Politics: The Collapse of the New GMO Regime in the EU’ (2011) 3 (2) European Journal of Risk Regulation 190 CrossRefGoogle Scholar.

29 Compare Art 5(6) Commission Decision (EC) 1999/468 [1999] OJ L184/23 and Art 6(3) Regulation 182/2011.

30 Recs 6, 14–15 Directive 2015/412 and COM(2015) 177, p 3; see also the original proposal: COM(2010) 375.

31 Kritikos, M, ‘Traditional Risk Analysis and Releases of GMOs into the European Union: Space for Non-Scientific Factors?’ (2009) 34 (3) European Law Review 405, p 431 Google Scholar; Hristova, V, ‘Between Politics and Science. Accommodating National Diversity in GMO Regulation’ in MBA van Asselt et al (eds), Balancing Between Trade and Risk Integrating Legal and Social Science Perspectives (Routledge, 2013), p 115Google Scholar.

32 Kritikos ibid, p 431; also Chalmers, D, ‘“Food for Thought”: Reconciling European Risks and Traditional Ways of Life’ (2003) 66 (4) The Modern Law Review 532, p 547 CrossRefGoogle Scholar.

33 Art 24 Directive 2001/18/EC and Art 6(7) Regulation 1829/2003 provide for public participation in risk assessment and the Commission has the (so far unexplored) possibility to consult an ethical committee.

34 Kritikos see note 31 above, p 419; Poli see note 14 above, p 149.

35 Interviews with EFSA Members by Kritikos see note 31 above, p 419.

36 Paskalev see note 28 above, pp 203–204 with reference to the dissenting opinions of two EFSA Members regarding the positive opinion for the Amflora Potato; also Wickson, F and Wynne, B, ‘The Anglerfish Deception’ (2012) 13 (2) EMBO Reports 100, p 102 CrossRefGoogle ScholarPubMed.

37 Similarly Hristova see note 31 above, p 114 and Skogstad see note 10 above, p 903.

38 Pfizer Animal Health SA v Council of the European Union, T-13/99, EU:T:2002:209, para 199; discussed by Janssen, A and van Asselt, MBA, ‘The Precautionary Principle in Court. An Analysis of Post-Pfizer Case Law’ in MBA van Asselt et al (eds), Balancing between Trade and Risk Integrating Legal and Social Science Perspectives (Routledge, 2013) 197 Google Scholar.

39 Similarly Kritikos see note 31 above, p 425; Weimer, W, ‘Legitimacy Through Precaution in European Regulation of GMOs?’ in C Joerges et al (eds), Transnational Standards of Social Protection Contrasting European and International Governance (Arena Reports, 2008) 159, pp 188–189 Google Scholar finds that Member States have been unable to compensate for this.

40 Commission, Communication to COM(2010) 375 COM(2010) 380, p 5; EPEC, Evaluation of the EU Legislative Framework in the Field of Cultivation of GMOs – Final Report to DG Sanco (March 2011) para 5.2.2; see also Part III.C below.

41 Christoforou, T, ‘The Regulation of Genetically Modified Organisms in the European Union: the Interplay of Science, Law and Politics’ (2004) 41 (3) Common Market Law Review 637, p 672 Google Scholar; Scott, J, ‘European Regulation of GMOs and the WTO’ (2003) 9 Columbia Journal of European Law 213, p 226 Google Scholar.

42 Scott ibid, pp 226–227; Dabrowska-Klosinska, P, Hybrid solutions for hybrid products?: EU Governance of GMOs (PhD Thesis, European University Institute, 2006) p 139 Google Scholar; Compassion in World Farming Ltd, C-1/96, EU:C:1998:113, paras 47, 53.

43 Commission Recommendation on coexistence, see note 16 above, para 2.4.

44 Pioneer Hi-Bred Italia v Italian Ministry of Agriculture, C-36/11, EU:C:2012:534, paras 72–76.

45 Eg Monsanto SAS v French Ministry of Agriculture and Fisheries, C‑58/10 to C‑68/10, EU:C:2011:553; Land of Upper Austria and Republic of Austria v Commission, EU:T:2005:347.

46 Hristova see note 31 above, p 116; Skogstad see note 10 above, pp 901–902.

47 Rec 7 Directive 2015/412; Commission, Explanatory Memorandum COM(2010) 375, p 8.

48 European Parliament ENVI Committee, Opinion on Legal Basis of COM(2010) 375 PE462.539v01-00 (29 March 2011) which questions the proposal’s ‘added value’.

49 Art 37 Regulation (EU) 582/2011 [2012] OJ L167/1.

50 Art 26(1) and (2) Directive 2001/18/EC.

51 Rec 7 Directive 2015/412.

52 Eg COM(2010) 380.

53 European Parliament, Report on proposal COM(2010) 375/2010/0208(COD) A7-0170/2011.

54 Amendments 35–36 ENVI Recommendations note 16 above.

55 Radlberger Getränkegesellschaft v Land Baden-Württemberg, C-309/02, EU:C:2004:799, para 53.

56 Similarly KPE Lasok and R Haynes, ‘Advice: In the Matter of the Proposed Regulation to Amend Directive 2001/18/EC’ (GM Freeze, 23 June 2010), paras 14–29 http://www.gmfreeze.org/site_media/uploads/publications/lasok_and_haynes-GMO_cultivation_ADVICE.pdf [last accessed 1 December 2015]; Weimer, M, ‘What Price Flexibility? The Recent Commission Proposal to Allow for National “Opts-Outs” on GMO Cultivation under the Deliberate Release Directive and the Comitology Reform Post-Lisbon’ (2010) 1 (4) European Journal of Risk Regulation 345, p 355 CrossRefGoogle Scholar.

57 Council Legal Service, Opinion COM(2010) 375 15696/10 (5 November 2010) and ENVI Legal Opinion (n 48), p 8. See contrarily G Winter, Nationale Anbaubeschränkungen und -verbote für gentechnisch veränderte Pflanzen und ihre Vereinbarkeit mit Verfassungs-, Unions- und Völkerrecht (German Federal Agency for Nature Conservation, May 2015) and H Gaßner et al, Rechtsfragen einer nationalen Umsetzung der Opt-out-Änderungsrichtlinie (German Federal Agency for Nature Conservation, May 2015) who argue that despite the explicit references to Arts 34–36 (Rec 16 Directive 2015/412) and Union Law, Art 26b should be treated as a self-standing provision of secondary law that exhaustively determines both the possibilities and the limitations for national opt-outs.

58 Dassonville, 8/74, EU:C:1974:82, p 852.

59 Lee, M, ‘The Ambiguity of Multi- Level Governance and (De-)Harmonisation in EU Environmental Law’ (2013) 15 Cambridge Yearbook of European Legal Studies 357, p 374 CrossRefGoogle Scholar.

60 Proceedings brought under Art 258 TFEU or in national courts, which, considering the ambiguities in Art 26b, are likely also to involve the Court through preliminary questions of interpretation, Art 267 TFEU. See also M Moore, Directive 2015/412 - judicial review of restrictions of cultivation of GMOs based on socioeconomic grounds (Conference Paper Budapest, 17 April 2015) http://www.nakvi.hu/app/gmo/doc/mmeu.pdf [last accessed August 2015].

61 Rewe-Zentral v Bundesmonopolverwaltung für Branntwein (Cassis de Dijon), C-120/78, EU:C:1979:42.

62 It was rejected as a basis for derogation under Art 114(5) TFEU as an economic, rather than an environmental ground, Land Oberösterreich and Austria v Commission, T-366/03 and T-235/04, EU:T:2005:347 as discussed by Fleurke, FM, ‘What Use for Art 95(5) EC? An Analysis of Land Oberösterreich and Republic of Austria v Commission’ (2008) 20 (2) Journal of Environmental Law 267 CrossRefGoogle Scholar.

63 Eg Rec 4 and para 2.3 Commission Recommendation on coexistence, see note 16 above; Lee, M, ‘The Governance of Coexistence Between GMOs and Other Forms of Agriculture: A Purely Economic Issue?’ (2008) 20 (2) Journal of Environmental Law 193 CrossRefGoogle Scholar.

64 Decker v Caisse de Maladie des Employés Privés, C-120/95, EU:C:1998:167, para 39; Chemische Afvalstoffen Dusseldorp v Dutch Ministry for Housing and the Environment, C-203/96, EU:C:1998:316, para 44.

65 European Commission, Considerations on Legal Issues on GMO Cultivation Raised in the Opinion of the Legal Service of the Council of the European Union of 5 November 2010 COM(2010) 1454, p 11; the Court has rejected such an exception in the context of the free movement of goods, eg Criminal Proceeding against Ditlev Bluhme, C-67/97, EU:C:1998:584. Hojnik, J, ‘De Minimis Rule within the EU Internal Market Freedoms: Towards a More Mature and Legitimate Market?’ (2013) 6 (1) European Journal of Legal Studies 25 Google Scholar.

66 Kathage, J et al, Framework for the Socio-Economic Analysis of the Cultivation of Genetically Modified Crops (Publications Office of the European Union, 2015)Google Scholar doi:10.2791/060437.

67 Openbaar Ministerie v Nertsvoerderfabriek Nederland BV, C-118/86, EU:C:1987:424, paras 14–15.

68 Margarethe Ospelt and Schlössle Weissenberg Familienstiftung, C-452/01, EU:C:2003:493, para 39; for discussion of the relevance of this case in the GMO context see Lee note 9 above, p 111.

69 Barnard, C, ‘Derogations, Justifications and the Four Freedoms: Is State Interest Really Protected?’ in C Barnard and P Odudu, The Outer Limits of European Union Law (Hart Publishing, 2009), p 278 Google Scholar.

70 Cullet v Leclerc, C-231/83, EU:C:1985:29; P Craig and G de Burca, EU Law. Text, Cases and Materials (Oxford University Press, 2011), p 670.

71 Commission v Poland, C-165/08, EU:C:2009:473, para 50; Rec 57 and Art 29 Directive 2001/18/EC.

72 Eg Regina v Henn and Darby, C-34/79, EU:C:1979:295 regarding pornographic materials and Omega, C-36/02, EU:C:2004:614 regarding violent videogames.

73 COGEM, Building Blocks for an Assessment Framework for the Cultivation of Genetically Modified Crops COGEM Report CGM/141222-01 (December 2014), p 35; Moore see note 60 above, p 2.

74 Roger, A, ‘In the public interest? A Comparative Analysis of Norway and the EU GMO Regulations’ (2015) 24 (3) Review of European, Comparative & International Environmental Law 264, p 276 CrossRefGoogle Scholar.

75 COM(2015) 176 see note 13 above, p 6 and fn 23.

76 Barnard see note 69 above, p 280; Lee see note 59 above, p 377 with reference to International Transport Workers’ Federation and Finnish Seamen’s Union v Viking Line, C-438/05, EU:C:2007:772.

77 Fedesa, C-331/88, EU:C:1990:391, para 13; about proportionality in the context of the proposal see also Lee note 59 above, p 377 and Dobbs, M, ‘Legalising General Prohibitions on Cultivation of Genetically Modified Organisms’ (2010) 11(12) German Law Journal 1347, p 1363 Google Scholar.

78 Opinion of Advocate General Bot in Pioneer Hi-Bred Italia v Italian Ministry of Agriculture, C-36/11, EU:C:2012:250, point 61; see more generally also Barnard note 69 above, p 282.

79 Winter see note 57 above, pp 30–32 on the discretion the proportionality principle would leave Member States to partially intervene to protect certain objectives by restricting GMO cultivation, while still permitting activities that may similarly threaten these objectives, like industrial agricultural practices, that may need regulation in the (near) future. However, about the difficulties in invoking a move towards a more sustainable agricultural system as a legitimate objective under Art 26b, see hereafter Part III.C.

80 Drawing an analogy with case law regarding proportionality in the context of consumer protection, eg Commission v Germany, C-178/84, EU:C:1987:126 and Cassis de Dijon, EU:C:1979:42 discussed by Barnard see note 69 above, p 283.

81 Rec 6 explicitly refers to Art 216(2) TFEU.

82 WTO Dispute Settlement, EC Biotech Products, WT/DS291–293/R, paras 7.1567–1568; 8.6–8.7.

83 For a more elaborate analysis see Dobbs note 77 above, p 1366; Opinion Council Legal Service see note 57 above, p 13; European Parliament Legal Service, Opinion COM(2010) 375 SJ-0630/10, p 6.

84 General Agreement on Tariffs and Trade (15 April 1994) 33 ILM 1153.

85 Annex A WTO Agreement on the Application of Sanitary and Phytosanitary Measures (15 April 1994) 1867 UNTS 493.

86 WTO Dispute Settlement, European Communities — Measures Affecting Asbestos and Products Containing Asbestos (12 March 2001), WT/DS135/AB/R, para 101.

87 M Lusser et al, Report International Workshop on Socioeconomic Impacts of Genetically Modified Crops (JRC-IPTS and FAO, 2012) pp 12–13; Kathage et al see note 66 above, p 17; COGEM see note 73 above, p 39.

88 WTO Dispute Settlement, United States — Measures Affecting the Cross-Border Supply of Gambling and Betting Services (16 January 2004), WT/DS285/R, par 6.465, 6.461; for discussion see Bossche, P van den, The Law and Policy of the World Trade Organisation (Cambridge University Press, 2013), p 570 Google Scholar.

89 WTO Dispute Settlement European Communities — Measures Prohibiting the Importation and Marketing of Seal Products (25 November 2013) WT/DS400/R, para 7.632.

90 WTO Dispute Settlement, China – Measures Affecting Trading Rights and Distribution Services for Certain Publications and Audiovisual Entertainment Products (12 August 2009), WT/DS363/R para 7.788; van den Bossche see note 88 above, p 570.

91 WTO Appellate Body Report, European Communities – Measures Prohibiting the Importation and Marketing of Seal Products (22 May 2014), WT/DS400/AB/R, par 5.3.2.5.

92 ‘“Gefahr für die Umwelt” Aigner verbietet Genmais-Anbau’ (Stern, 14 April 2009) http://www.stern.de/wissen/ernaehrung/gefahr-fuer-die-umwelt-aigner-verbietet-genmais-anbau-660801.html [last accessed August 2015]; LOI No 2014-567 du 2 juin 2014 relative à l’interdiction de la mise en culture du des variétés de maïs génétiquement modifié, JORF (3 June 2014) No 0127, p 9208.

93 Eg the Environmental Monitoring Plan for Maize Bt11(non-cultivation), drafted in accordance with Annex VII Directive 2001/18/EC: http://ec.europa.eu/food/dyna/gm_register/100222-monitoringplan-Bt11.pdf [last accessed August 2015].

94 See Part I above and the recording of the Council (Agriculture and Fisheries) negotiations on 13 July 2015 at http://video.consilium.europa.eu/webcast.aspx?ticket=775-979-16166 [last accessed August 2015].

95 Commission v Poland, EU:C:2009:473, paras 52–55.

96 Gaßner et al see note 57 above, p 26.

97 Note that to the extent that environmental aims are brought outside the harmonisation scope, they may require protection as ‘mandatory requirements’ as accepted in, eg, Case C-2/90 Commission v Belgium [1992] ECR I-4431 (Walloon Waste).

98 Rec 14 Directive 2015/412 and Part II.B above.

99 Art 3 Directive 2015/412; EFSA Panel on Genetically Modified Organisms, ‘Guidance on the Environmental Risk Assessment of Genetically Modified Plants’ (2010) 8 (11) EFSA Journal 1879 CrossRefGoogle Scholar, sec 2.3.

100 Ibid, pp 24–25.

101 Winter see note 57 above, p 14; also Lee see note 59 above, fn 77. Compare the text of Art 26b(3)(a) following the ENVI Recommendations see note 16 above: ‘environmental policy objectives ... which are complementary to the impacts concretely examined during the scientific risk assessment’ [emphasis added].

102 This defendable conclusion would also restrict Member States’ possibilities to rely on other grounds listed by Winter in note 57 above, p 14 (apparently inspired by the amendments proposed by MEPs Staes and Boylan that were only partly reflected in the ENVI Recommendations in note 16 above, Amendment 17) that are not concretely assessed by EFSA, although such considerations are formally a part of the central ERA. In the context of COM(2010) 375 see Lasok and Haynes see note 56 above, paras 30–35.

103 Application EFSA-GMO-CZ-2008-54 (MON88017 maize CULTIVATION) – Scientific comments and opinions submitted by EU Member States, Annex G, pp 3–4, EFSA Register of Questions EFSA-Q-2011-01117.

104 Land Oberösterreich and Austria v Commission, C-439/05 P and C-454/05, EU:C:2007:510, paras 54–55.

105 Similarly Poli see note 14 above, p 150.

106 Rec 14 Directive 2015/412.

107 EFSA Guidance see note 99 above, sec 3.5, examples p 71.

108 Eg ibid, pp 3, 11.

109 Similarly Wickson and Wynne see note 36 above.

110 EFSA Guidance see note 99 above, p 70; eg EFSA Panel on Genetically Modified Organisms, ‘Scientific Opinion on Application (EFSA-GMO-NL-2005-24) for the Placing on the Market of the Herbicide Tolerant Genetically Modified Soybean 40-3-2 for Cultivation under Regulation (EC) 1829/2003 from Monsanto’ (2012) 10 (6) EFSA Journal 2753, in which GMO related cultivation practices (spraying of glyphosate on the crop) is compared to conventional practices (pre-sowing use of glyphosate), rather than agroecological farming practices which do not use glyphosate at all.

111 EFSA Guidance see note 99 above, p 21, recognises that ‘whereas in general parlance the term “comparator” applies to the plant, ERA must account for the production system as a whole’.

112 Ibid, pp 24 and 21 which note that comparisons should be made with (current) representative management techniques ‘rather than “untreated” regimes which may be agronomically less realistic’; also Roger see note 74 above, part IV.

113 Eg EFSA Panel on GMO see note 110 above, pp 35–36.

114 Ibid, pp 76–77; EFSA Panel on Genetically Modified Organisms, ‘Scientific Opinion on application (EFSA-GMO-UK-2008-60) for the Placing on the Market of Herbicide Tolerant Genetically Modified Maize 98140 for Food and Feed Uses, Import and Processing Under Regulation (EC) 1829/2003 from Pioneer Overseas Corporation’ (2011) 10 (6) EFSA Journal 3139, pp 76–77 Google Scholar.

115 Ibid.

116 A Neslen and T Levitt, ‘Weedkiller suspected of causing cancer deemed “safe”’ (The Guardian, 15 July 2015) http://www.theguardian.com/environment/2015/jul/15/weedkiller-suspected-of-causing-cancer-deemed-safe [last accessed August 2015].

117 Regulation (EC) 1107/2009 [2009] OJ L309/1.

118 Gaßner et al see note 57 above, pp 33–43, 51–54.

119 Recs 2 and 14 Directive 2015/412.

120 Eg EFSA Panel on Genetically Modified Organisms, ‘Scientific Opinion Updating the Evaluation of the Environmental Risk Assessment and Risk Management Recommendations on Insect Resistant Genetically Modified Maize 1507 for Cultivation’ (2011) 9 (11) EFSA Journal 2429Google Scholar; see also Klika et al see note 26 above, p 330; Gaßner et al see note 57, pp 48–49.

121 Klika et al see note 26 above, p 330; Hristova see note 31 above, p 109.

122 EFSA Guidance above note 99, p 13.

123 See Paskalev note 28 above, p 203; Hungary v Commission, T‑240/10, EU:T:2013:645, para 37.

124 Similarly Wickson and Wynne see note 36 above and Part III.C above.

125 Winter see note 57 above, p 14.

126 Amendment 17 ENVI Recommendations see note 16 above.

127 Winter see note 57 above, pp 15–16.

128 For various examples see Winter note 57 above, p 15. However, Rec 3 Directive 2015/412 explicitly recognises these considerations to be part of the (harmonised) EU’s risk-assessment that needs to be ‘regularly updated’.

129 See more extensively on minimum environmental harmonisation as the only adequate solution, based on the redistribution of competences, for all the regime’s diversity problems: M Geelhoed, ‘A Growing Impasse: the Future of the EU’s GMO Regime’ (University of Edinburgh, Europa Working Paper 2014/08, 14 November 2014), sec 3.4, although placing the discussion in the context of the (possibly wrong) legal basis of the GMO regime.

130 Ibid, Art 114 TFEU and Part II.C above. See also Rec 2 Directive 2015/412.

131 EU Council, Council Conclusions on Genetically Modified Organisms [2008] 16882/08, notably paras 1–4 and 7–10.

132 Paskalev see note 28 above, p 7 and Art 30(4) Regulation 178/2002.

133 Chalmers, D, ‘Risk, Anxiety and the European Mediation of the Politics of Life’ (2005) 30 (5) European Law Review 649, p 661 Google Scholar.

134 Dabrowska-Klosinska, P, ‘Towards More Experimentalism in the EU Governance on GMO Risks? Regulatory Experience, Responsive Reforms and Remaining Problems’ (2013) APSA 2013 Annual Meeting Paper, p 14 Google Scholar; Perry, J N et al, ‘Response to “The anglerfish deception”’ (2012) 13 (6) EMBO Reports 481 CrossRefGoogle Scholar.

135 A Bauer-Panskus and C Then, ‘Case study: Industry Influence in the Risk Assessment of Genetically Engineered Maize 1507’ (TestBiotech, 10 April 2014) https://www.testbiotech.org/node/1030 [last accessed August 2015].

136 Rec 19 Directive 2015/412; about the overprotection of commercial interests at the expense of transparency regarding safety risks: Nielsen, K M, ‘Biosafety Data as Confidential Business Information’ (2013) 11 (3) PLOS Biology e1001499CrossRefGoogle ScholarPubMed.

137 See, eg Member States’ comments to the MON88017 maize opinion, note 103 above.

138 EFSA Panel on Genetically Modified Organisms, ‘Scientific Opinion Supplementing the Conclusions of the Environmental Risk Assessment and Management Recommendations on the Genetically Modified Insect Resistant Maize 1507 for Cultivation’ (2012) 10 (11) EFSA Journal 2934 Google Scholar.

139 Ibid, p 3.

140 Dabrowska-Klosinska see note 134 above, p 9.

141 WTO Dispute Settlement, EC Biotech, WT/DS291–293/R, condemned the EU’s ‘undue delays’ in its approvals and Member States safeguard measures for not being based on ‘an assessment’ (Art 5.1 and Annex A(4) SPS Agreement).

142 Art 1.1–1.2 and Annex 1 SPS Agreement; for discussion of the WTO Panel’s extensive interpretation of the scope of the SPS Agreement see: Peel, J, ‘A GMO by Any Other Name ... Might Be an SPS Risk!: Implications of Expanding the Scope of the WTO Sanitary and Phytosanitary Measures Agreement’ (2006) 17 (5) European Journal of International Law 1009CrossRefGoogle Scholar.

143 Art 2.2 SPS Agreement; Cheyne, I, ‘Case Notes – Life After the Biotech Products Dispute’ (2008) 10 (1) Environmental Law Review 52, p 61 Google Scholar.

144 In the former case, Art 5(7) SPS Agreement explicitly permits precaution.

145 WTO Appellate Body Report, EC Measures Concerning Meat and Meat Products (Hormones) (16 January 1998) WT/DS26/AB/R, WT/DS48/AB/R, para 194; Zander, J, The Application of the Precautionary Principle in Practice (Cambridge University Press, 2010), p 73 CrossRefGoogle Scholar; Gruszczynski, L, Regulating Health and Environmental Risks Under WTO Law (Oxford University Press, 2010), p 136 CrossRefGoogle Scholar.

146 Ivanova, Likewise B and van Asselt, MBA, ‘Pre-Empting Precaution – GMO Trade Conflicts, Uncertainty Intolerant Risk-Assessment and Precaution-based Risk Management’ in MBA van Asselt et al (eds), Balancing Between Trade and Risk Integrating Legal and Social Science Perspectives (Routledge, 2013), p 94 Google Scholar.

147 Alemanno, A, ‘Public Perception of Food Safety Risks Under WTO Law: A Normative Perspective’ in G Van Calster and D Prévost (eds), Research Handbook on Environment, Health and the WTO (Edward Elgar Publishing, 2013)Google Scholar.

148 Epps, T, ‘Reconciling Public Opinion and WTO Rules Under the SPS Agreement’ (2008) 7 (2) World Trade Review 359, p 384 CrossRefGoogle Scholar and (albeit more cautiously) Alemanno ibid, p 288, referencing EC Hormones, WT/DS26/AB/R and its follow-up United States — Continued Suspension of Obligations in the EC — Hormones Dispute (16 October 2008), WT/DS320/AB/R.

149 Epps ibid, p 373 and Alemanno see note 147 above, p 281, with reference to Arts 5.4–5.7 SPS Agreement.

150 In both EC Hormones, WT/DS26/AB/R and EC Biotech, WT/DS291–293/R the SPS measures were not supported at all by the assessment carried out.

151 Whose legitimacy has been challenged due to conflicts of interest and democratic deficits, see, eg Decision of the European Ombudsman Closing the Inquiry Into Complaint 346/2013/SID Against the European Food and Safety Authority (‘EFSA’) http://www.ombudsman.europa.eu/cases/decision.faces/en/58868/html.bookmark [last accessed 2 December 2015].

152 See Part I above.

153 J Juncker, A New Start for Europe: My Agenda for Jobs, Growth, Fairness and Democratic Change (Strasbourg, 15 July 2014) http://www.eesc.europa.eu/resources/docs/jean-claude-juncker---political-guidelines.pdf [last accessed August 2015], p 11.

154 European Commission, Commissioner Andriukaitis welcomes provisional political agreement on GMO cultivation STATEMENT/14/2363.

155 S Carrell, ‘Scotland to Issue Formal Ban on Genetically Modified Crops’ (Guardian, 9 August 2015) http://www.theguardian.com/environment/2015/aug/09/scotland-to-issue-formal-ban-on-genetically-modified-crops [last accessed August 2015].