1 There is another GMO which can be grown – the maize MON810, but it was authorised in the 90s under the old regime. There are several other GMOs which were authorised under the current regime but for use only and they must be grown elsewhere.

2 Even though the announcement of the prospective regime change was prompted by the authorisation of the Amflora, it was by no means caused by it; the prospect for amendments was conceived as early as 2008 (see below).

3 For detailed and comprehensive accounts of the issues in the context of international law and the transatlantic relations see Alemanno, Alberto, Trade in Food: Regulatory and Judicial Approaches in the EU and the WTO (London: Cameron May, 2007)Google Scholar and also Pollack, Mark A. and Shaffer, Gregory C., When cooperation fails: The international law and politics of genetically modified foods (Oxford: Oxford University Press, 2009)CrossRefGoogle Scholar.

4 For a detailed history of the biotech regulation in EU see Morris, Shane H. and Spillane, Charles, “EU GM crop Regulation: A Road to Resolution or a Regulatory Roundabout?”, 1 European Journal of Risk Regulation (2010), p. 359 et sqqCrossRefGoogle Scholar.

5 Levidow, Les and Carr, Susan, GM Food on Trial (London: Routledge, 2010), at p. 139 Google Scholar.

6 Ibid., p. 144.

7 Communication from the Commission – The operating framework for the European Regulatory Agencies, COM (2002/0718 final),

8 Levidow mentions that “some politicians” did sought that, and that comitology provided convenient way to do so. See Les Levidow and Susan Carr, GM Food on Trial, supra note 5, at p. 151.

9 Maria Weimer, “Legitimacy through Precaution in European Regulation of GMOs? From the Standpoint of Governance as Analytical Perspective”, in Christian Joerges and Poul F. Kjaer (eds.), Transnational Standards of Social Protection Contrasting European and International Governance, vol 5 (ARENA Report No 5/08, RECON Report No 4 2008), p. 161. She postulates these two imperatives to apply to decisions pursuant to the precautionary principle, but in my view in the complex and rationalised democracies of today the same is valid for any authoritative decision.

10 Maria Weimer, “Legitimacy through Precaution in European Regulation of GMOs”, supra note 9, at p. 162.

11 See Chalmers, Damian, “Risk, Anxiety and the European mediation of the Politics of Life”, 30 European Law Review (2005), p. 649 et sqqGoogle Scholar.

12 Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (12 March 2001), hereinafter ‘Deliberate Release Directive’.

13 Regulation 1829/2003/EC on genetically modified food and feed (22 September 2003), hereinafter ‘Food and Feed Regulation’.

14 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 (28 January 2002),

15 Article 2, para 8 of the Deliberate Release Directive.

16 There is explicit reference to it in recital 8 of the Directive.

17 Ibid., recital 19.

18 Ibid., recital 24.

19 Food and Feed Regulation, art. 4, para 1.

20 See Holder, Jane, Lee, Maria and Elworthy, Sue, Environmental protection, law and policy: Text and materials, 2nd edn. (Cambridge: Cambridge University Press, 2007)CrossRefGoogle Scholar for a comprehensive account of the considerations that are important for different stakeholders.

21 Lee, Maria, EU Regulation of GMOs: Law and Decision Making for a New Technology (Cheltenham: Edward Elgar, 2008), at p. 86 CrossRefGoogle Scholar.

22 In theory the Deliberative Release Directive creates regime of mutual recognition, and only in case of disagreement the decision is centralised by comitology and upon an optional advice of EFSA. However, Member States always rise and maintain objections, and the Commission always asks the EFSA opinion.

23 For a more detailed account see Lee, Maria, EU regulation of GMOs: Law and decision making for a new technology (Cheltenham: Edward Elgar, 2008)CrossRefGoogle Scholar; for a more recent review see Pollack, Mark A. and Shaffer, Gregory, “Biotechnology Policy. Between National Fears and Global Disciplines” in Wallace, Helen, Pollack, Mark A. and Young, Alasdair R. (eds.), Policy-making in the European Union, 6th edn. (Oxford: Oxford University Press, 2010)Google Scholar.

24 Deliberate Release Directive, recital 46 and Article 9.

25 Les Levidow and Susan Carr, GM Food on Trial, supra note 5, at p. 153 with reference to Maria Paola Ferretti.

26 For more details on EFSA see General Food Law Regulation.

27 Pollack and Shaffer quoted a Commission report according to which “out of 2 637 draft decisions submitted to the various EU expert committees that year, only eleven of those decisions (less than 0,5 per cent) were referred to the Council for a decision – and six of these involved authorisation of GM foods and crops.” Mark A. Pollack and Gregory Shaffer, “Biotechnology Policy. Between National Fears and Global Disciplines”, supra note 24.

28 The exception being its decisions from 24 June 2005, 18 December 2006 and 20 February 2007 to block infringement proceedings against Member States for bans of authorised GMO’s.

29 Now the comitology procedure is thoroughly reviewed with regard to the Lisbon Treaty. Maria Weimer provides an in-depth account of the consequences for the GMO regulation in “Legitimacy through Precaution in European Regulation of GMOs”, supra note 9. In my view whatever the changes, their effect will have negligible significance on this issue as the root of the problem is not in the procedure.

30 This is the ‘safeguard clause’, see Art. 23 of the Deliberate Release Directive.

31 The data is provided from Schauzu, Marianna, “The European Union's Regulatory Framework” in Baram, Michael and Bourrier, Mathilde (eds.), Governing Risk in GM Agriculture (Cambridge: Cambridge University Press, 2011)Google Scholar.

32 Less Levidow and Susan Carr, GM Food on Trial, supra note 5, at p. 140.

33 Chalmers, Damian, “‘Food for Thought’: Reconciling European Risks and Traditional Ways of Life” 66 Modern Law Review (2003), p. 532 et sqq., at p. 540CrossRefGoogle Scholar.

34 There is a special regulation on this, see Commission Regulation 2230/2004 laying down detailed rules for the implementation of Regulation No 178/2002 with regard to the network of organisations operating in the fields within the EFSA's mission (23 December 2004).

35 Maria Lee, EU Regulation of GMOs, supra note 24, at p. 68.

36 General Food Law Regulation, art. 30 (2).

37 General Food Law Regulation, art. 30 (2), emphasis added. An recent example of such resolving of differences was a study on long term effects of GM maize on rats, commissioned and presented in the Food Chain Committee by Austria. See the minutes from the proceedings of EFSA GMO panel on 3–4 December and of the Food Chain Committee on 16 December 2008 and 19 October 2009 respectively. Later Austria withdraw the study.

38 As will be seen latter, in practice the problem often remains as the local safety issues arise only in relation to “extra-scientific” issues like the health or farming policies, consumption patterns, etc which are not taken into account by EFSA.

39 van Asselt, Marjolein B.A. and Vos, Ellen, “Wrestling with uncertain risks: EU regulation of GMOs and the uncertainty paradox”, 11 Journal of Risk Research (2008), p. 281 et sqq., at p. 284CrossRefGoogle Scholar. More alarmingly they noticed examples that EFSA failed to be even such quality check: the applicant did not disclose an unfavourable study that was available to him and even when this became publicly known EFSA took no action.

40 I haste to distinguish myself from the popular corporations-bashing crowd; companies do care for safety and for their image; on the other hand experts have their own dependencies and biases as well. Nevertheless, companies’ concern for safety is conditioned by the precise boundaries of their legal liability and by their PR policy so they balance the safety and profit concerns quite differently.

41 Accusations that EFSA is captured by the biotech industry come from environmentalists and even from academia; in my view whether this is the case is contingent because the very design of the regime creates the problem.

42 Les Levidow and Susan Carr, GMO Food on Trial, supra note 5, p. 153.

43 The case study is based only on the documents which are published. The opinions of the national authorities which were discussed by EFSA and the Food Chain Committee are known only to the extend that they are addressed in the minutes from the proceedings of the relevant European institutions. The opinions of the NGOs are taken from publications on their own web sites.

44 Assessment report of the Swedish Competent Authority on the placing on the market according to notification C/SE/96/3501.

45 Ibid.

46 EFSA, Opinion of the Scientific Panel on GMO on a request from the Commission related to the notification (Reference C/ SE/96/3501) for the placing on the market of GM potato EH92- 527-1 with altered starch composition, for cultivation and production of starch, under Part C of Directive 2001/18/EC from BASF Plant Science (2006), published in The EFSA Journal (2006) 323, 1–20, hereinafter Amflora Opinion 2005. Actually there were two opinions, with almost identical content – for the purposes of the Deliberate Release Directive and of the Food and Feed Regulation respectively. All references below will be to the opinion pursuant to the Deliberate Release Directive.

47 Amflora Opinion 2005.

48 Maria Lee, EU Regulation of GMOs, supra note 24, at p. 29.

49 Amflora Opinion 2005, p. 10. Emphasis added, note how little the language of this scientific assessment differs from that of a moral judgement.

50 Amflora Opinion 2005, p. 11

51 Amflora Opinion 2005, p. 11, emphasis added.

52 This is the popular name of the methodological principle, initially formulated by Duns Scotus in 13c AD also known as the Law of Parsimony, “which prohibits, without a proven necessity, the multiplication of entities, powers, principles or causes” ( Hamilton, William, Discussions on philosophy and literature, education, and university reform (Harper & Brothers 1856), p. 580)Google Scholar. It is still dominating scientific reasoning today: “nature may or may not favour simplicity, but we should certainly do so – simply as a matter of rational procedure. … [this is] a methodological tool of inquiry.” Rescher, Nicholas, Aesthetic factors in natural science (Lanham, MD.:University Press of America, 1990), pp. 3–4 Google Scholar.

53 Maria Lee, EU Regulation of GMOs, supra note 24, at p. 29.

54 Maria Weimer, “Legitimacy through Precaution in European Regulation of GMOs?”, supra note 9, at p. 195.

55 Press release from the 2713th Council Meeting (Environment), 9 March 2006, 6762/06 (Presse 58), available on the Internet at <http://www.consilium.europa.eu/uedocs/NewsWord/en/envir/88721.doc> (last accessed on 12 April 2012).

56 Ibid.

57 See Commission press release from 12 April 2006 (IP/06/498) available on the Internet at <http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/498> (last accessed on 12 April 2012).

58 Ibid.

59 Indeed it remanded the Amflora dossier back to EFSA several times.

60 Les Levidow and Susan Carr, GMO Food on Trial, supra note 5, at p. 155. However they emphasise that there is an important tradeoff: “As a practical reform, [new measures] could provide a way to accommodate more Member States through greater rigour and thus potentially gain more votes for Commission proposals. On the other hand, if greater transparency meant a more explicit uncertainty, then this could undermine safety claims as ‘objective’ advice.” (Ibid).

61 Ironically the very same efforts to make EFSA the best cognitive authority by integration of expertise from national authorities and develop consensus between them undermine the capacity of the Commission to find alternative scientific grounds to justify such decisions.

62 Meetings held on 15 May 2006 and 19 June 2006.

63 Ibid.

64 Commissioner Dimas answering a written question by Alyn Smith, MEP (E-0769/2007), available on the Internet at <http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2007-0769&language=EN> (last accessed on 12 April 2012).

65 The antibiotic resistance had been a contentious issue in EU for quite some time and beyond the GMO debate; this was the bone of contention in the landmark Pfizer case as well. There was a proposal in the European Parliament for immediate ban of ARMG in GMOs which was defeated; however it was enshrined into law that ARMGs should be phased out by 2005.

66 EFSA Opinion 2004, p. 13.

67 EFSA, Opinion of the Scientific Panel on GMO on the use of antibiotic resistance genes as marker genes in genetically modified plants (2004). Hereinafter “ARMG Opinion”, p. 11.

68 World Health Organisation, World Health Organisation, Critically Important Antibacterial Agents for Human Medicine for Risk Management Strategies of Non-Human Use. Report of a WHO working group consultation (2005)

69 In the meantime the Commission proceeded with the authorisation pursuant to the Deliberative Release Directive, proposing approval through the comitology, which on 19 December 2006 failed to reach decision and the matter was referred to the Council, which also failed on 16 July 2007. This cleared the way for Commission approval of deliberative release and marketing, but it withheld it until the controversy pursuant to Food and Feed Regulation continued.

70 EMA, ‘Committee for Medicinal Products for Veterinary Use And Committee For Medicinal Products For Human Use Presence of the ARMG nptII in GM plants for Food and Feed Uses’ EMEA/CVMP/56937/2007 ibid., hereinafter ‘EMEA Opinion’, at p. 2. It also indicated few other misgivings in the EFSA opinion, esp. noting that the occurrence of kanamycin resistance, which was judged as widespread by EFSA actually varies substantially between countries and species.

71 EFSA, Statement of the Scientific Panel on GMO on the safe use of the nptII antibiotic resistance marker gene in genetically modified plants (2007).

72 The procedure is governed by Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.

73 Deliberate Release Directive, Art. 2, para 2.

74 EFSA, ‘Statement of EFSA on the consolidated presentation of opinions on the use of antibiotic resistance genes as marker genes in genetically modified plants’ The EFSA Journal 1108 Appendix D.

75 Minutes of the 1907th meeting of the Commission held in Brussels (Berlaymont) on Wednesday 3 March 2010 (PV(2010)1907 final), at p. 23 available on the Internet at <http://ec.europa.eu/transparency/regdoc/rep/10061/2010/EN/10061-2010-1907-EN-F-0.Pdf>, (last accessed on 2 April 2012).

76 Maria Weimer, “Legitimacy through Precaution in European Regulation of GMOs?”, supra note 9, at p. 162.

77 For details see Poli, Sara, “The Commission's New Approach to the Cultivation of Genetically Modified Organisms”, 1 European Journal of Risk Regulation (2010), p. 339 et sqqCrossRefGoogle Scholar.

78 See Euractiv, Paper reveals EU plan to boost GM crop cultivation, published on 4 May 2010, available on the Internet at <http://www.euractiv.com/cap/paper-reveals-eu-plan-boost-gm-crop-cultivation-news-493647> (last accessed on 2 April 2012).

79 The scope and the grounds of such bans are still debated and merit separate article.

80 ‘GMOs: EU's legislation on the right track, evaluation reports conclude,’ European Commission press release, 28 October 2011, available on the Internet at <http://europa.eu/rapid/pressReleases-Action.do?reference=IP/11/1285> (last accessed on 2 April 2012).

81 Case T-240/10, Hungary v. European Commission, action brought on 27 May 2010.

82 This leaves the maze MON 810 (authorized in 1998 under the old regime) the only GM crop currently grown in Europe.

83 Maria Weimer, “Legitimacy through Precaution in European Regulation of GMOs?”, supra note 9, at p. 195.

84 Alemanno, Alberto, “EU Risk Regulation and Science: The Role of Experts in Decision-making and Judicial Review”, in Vos, Ellen (ed.), European Risk Governance: Its Science, its Inclusiveness and its Effectiveness, vol 6 (Mannheim: CONNEX 2008), at p. 47 Google Scholar.

85 Shane H. Morris and Charles Spillane, “EU GM crop Regulation”, supra note 4, at p. 368, with reference to Sheila Jasanoff.

86 It is common feature of the EU to achieve its goals by creation of baroque governance structures which in most other cases work surprisingly well. Comitology for example is a mechanism unseen in any other constitutional system which regularly squares such circles. For a seminal article see Joerges, Christian and Neyer, Jurgen, “From Intergovernmental Bargaining to Deliberative Political Processes: The Constitutionalisation of Comitology”, 3 European Law Journal (1997), p. 273 et sqqCrossRefGoogle Scholar.

87 See Damian Chalmers, “Risk, Anxiety and the European mediation of the Politics of Life”, supra note 12.