1 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, OJ [2015], L 68/1.

2 Directive 2011/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ [2001], L106/39.

3 Communication from the Commission to the European Parliament, the Council, the European economic and socialcommittee and the Committee of the Regions, Reviewing the decision-making process on genetically modified organisms (GMOs), COM (2015) 176 of 22 April 2015.

4 Regulation (EC) N. 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, OJ [2003], L 268/1.

5 Proposal for a Regulation of the European parliament and of the Council amending Regulation (EC) No 1829/2003 as 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 of 22 April 2015.

6 Zbíral, R., Restoring tasks from the European Union to Member States: A bumpy road to an unclear destination? (2015) 52 Common Market Law Review, 1, p. 57 Google Scholar.

7 Greater attention will be devoted to Directive 2015/412 given that is has been approved whereas the proposed Regulation amending Regulation 1829/2003 may change during the legislative itinerary.

8 The amflora potato was authorised in 2010. However, the authorization decision was successfully challenged before the General Court in Case T-240/10 Hungary v. Commission, ECLI:EU:T:2013:645. The Commission violated an essential infringement requirements by not sending the amended draft proposals to the competent Regulatory Committee under art. 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ [1999] L 184/23.

9 The area of cultivation covers 1.5% of the total land devoted to maize production. COM (2015) 176, p. 4.

10 See Questions and Answers on EU's policies on cultivation and imports of GMOs, 6 November 2013 published on http://europa.eu/rapid/press-release_MEMO-13-952_en.htm (last accessed on 2 June 2015).

11 Communication from the Commission to the European Parliament, the Council, the Economic and Social Committeeand the committee of the regions on the freedom for Member States to decide on the cultivation of genetically modified crops, COM (2010) 375, p. 2.

12 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January2002 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, OJ [2002] L31/1. See the French legislation at stake in Cases C-58/10 to C-68/10, Monsanto SA and others v. Ministre de l’Agriculture et de la peche, [2011] ECR I-07763.

13 COM (2010) 375, p. 2.

14 C-165/08, Commission v. Poland, [2009] ECR I-06843.

15 For more information see Poli, S., Scientific advice in the GMO area, in Alemanno, A., Gabbi, S., Foundations of EU Food Law and Policy: Ten Years of the European Food Safety, Ashgate, 2014, p. 119–131 Google Scholar.

16 See the negative Decision issued by the Commission on the application for derogation from Directive 2011/18 under Art. 114(5) TFEU by Upper Austria. Commission decision of 2 September 2003 relating to national provisions on banning the use of genetically modified organisms in the region of Upper Austria notified by the Republic of Austria pursuant to Article 95(5) of the EC Treaty, [2003] OJ L 230/34.

17 See Joined cases C-439/05 P and C-454/05 P, Land Oberösterreich and Republic of Austria v Commission of the European Communities, [2007] ECR I-07141.

18 C-58/10 to C-68/10, cit., par. 77.

19 See C-36/11, Pioneer Hi Bred Italia Srl v. Ministero delle politiche agricole e forestali, ECR 2012 I-000; see also Order of 8 May 2013, C-542/12 Fidenato, nyr.

20 This provision “entitled ‘Measures to avoid the unintended presence of GMOs’, reads as follows: ‘1. Member States may take appropriate measures to avoid the unintended presence of GMOs in other products. […]”

21 Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species, OJ [2002] L193/1.

22 The Commission found itself stuck between a rock and hard place in the context of the request for authorization to cultivate the GM maize 1507. Indeed, when the EFSA released a positive opinion on the application for authorization Member States objected EFSA's opinions. In this situation, the Commission has delayed as much as possible the submission of the draft authorization to cultivate a given GMO to the regulatory committee in order to avoid a rejection of the draft authorization by the Council. For this reason this institution has also been sanctioned by the Court for failure to act in relation to the request of authorization to cultivate the maize 1507. T-164/10, Pioneer Hi-Bred International v. Commission of 26 September 2013. A first application for failure to act was lodged in 2007 (see T-139/07) but the Court concluded that there was no need to adjudicate the case since the Commission had decided to submit the proposal for a decision on the cultivation of GM maize 1507 to the relevant committee of national representatives. See memo “GMO: Commission asks Council to agree on its proposal to grant Member States more subsidiarity on cultivation” of 6 November 2013 published on http://Europa-eu/rapid/press-release_MEMO-13-952_en.htm (last accessed 2 June 2015). It should be noted that under Art. 41 of the EU Charter of Fundamental rights, administrative decisions in the context of a prior authorization system must be taken within a reasonable period of time. Therefore, this means that it will be more and more difficult for the Commission to simply abstain for an unlimited period of time from taking any decision in case the relevant Committee takes the position of “no opinion.” COM (2015) 176, cit., p. 3-4.

23 Fact Sheet: Questions and Answers on EU's policies on GMOs, Brussels, 22 April 2015, http://europa.eu/rapid/press-release_MEMO-15-4778_en.htm (last accessed on 2 June 2015).

24 COM (2015) 176, p. 5.

25 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers, OJ [2011] L 55/13.

26 Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ [1999] L 184/23. The authorization decisions under Directive 2001/18 and Regulation 1829/2003 were based on the procedure laid down by Art. 5 (regulatory procedure) as amended by Council Decision 2006/512.

27 This is the so-called examination procedure.

28 The Regulatory committee in the context of Council Decision 1999/468/EC, cit.

29 In particular, the “examination committee” did not deliver any opinion since it could not achieve the required qualified majority voting both in favour or against the marketing authorization.

30 COM (2015) 176, p. 7.

31 Regulation 182/2011 gives more discretion to the Commission than under the regulatory procedure of the old Comitology Decision of 1999.

32 See Art. 7 and 19 of Regulation 1829/2003, cit.

33 COM (2015) 176, p. 6.

34 COM (2015) 177, p. 3-4.

35 Articles 7 and 19 of Regulation (EC) No 1829/2003 provide that the Commission may, in addition to EFSA's opinion, take into account “other legitimate factors relevant to the matter under consideration.”

36 Panel reports on European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R (United States), WT/DS292/R (Canada), WT/DS293/R (Argentina), approved by the Dispute Settlement Body on 21 November 2006.

37 Environment Council conclusions of 4 December 2008.

38 Bulgaria, Cyprus, Ireland, Greece, Latvia, Lithuania, Hungary, Luxembourg, Malta, Slovenia and Poland.

39 Council document n. 11226/2/09 REV 2.

40 Recital n. 6.

41 Recital n. 8 states: “It appears appropriate to grant Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMOs on their territory.”

42 R. Zbíral, supra n. 6, p. 54.

43 Christoforou, T., “The Regulation of genetically modified Organisms in the European Union: the Interplay of Science, Law and Politics,” (2004) 41 CMLRev, 637 Google Scholar.

44 Recital n. 7.

45 Recital n. 3.

46 Position (EU) No 9/2014 of the Council at first reading, point 2, second paragraph, OJ [2014] C349/1.

47 OJ [1998] L 204/37.

48 In Case C- 36/11, cit, the Court had held: “In conclusion, Article 26a of Directive 2001/18 can give rise to restrictions, or even to geographically restricted prohibitions, only through the effect of coexistence measures actually adopted in compliance with the objective of that directive. Accordingly, that provision does not permit the Member States to adopt a measure such as that at issue in the main proceedings which, pending adoption of coexistence measures, lays down a general prohibition on cultivation of GMOs authorised under European Union law and listed in the common catalogue.” Par. 75.

49 Recital n. 13.

50 The mechanism of scrutiny that of draft national measures restricting the cultivation of GMOs applies to the exclusion of that of Directive 98/34.

51 Recitals n. 11 and 12.

52 Late requests from Member States are also possible. See Art. 26 b (2) third paragraph.

53 The Commission must present the demand of the Member State to the notifier/applicant and to the other Member States without delay.

54 Art. 26 b (3).

55 Art. 26 b (3) of Directive 2015/412, cit.

56 Recital n. 14.

57 Recital n. 15

58 Ibidem.

59 Commission Decision 2009/828/EC of 3 November 2009 relating to the draft Regional Legislative Decree declaring the Autonomous Region of Madeira to be an Area Free of Genetically Modified Organisms, notified by the Republic of Portugal pursuant to Article 95(5) of the EC Treaty, OJ [2009] L 294/16.

60 Recital n. 6 of Directive 2015/412.

61 The reference is made to the need to comply with Art. 216(2)TFEU in Recital 16 of Directive 2015/412.

62 R. Zbíral, supra 6, p. 66.

63 See the examples of decentralization in the enforcement of EU competition law or the reform of the common agricultural policy in 1990s which moved from the subsidy of production to the subsidy of producers. R. Zbíral, supra 6, p. 72.

64 R. Zbíral, supra 6, p. 73.

65 I thank the anonymous referee who suggested this interpretation.

66 Recital n. 5 imposes on Member States to restrict the cultivation of GMOs only under the conditions defined by Union law.

67 A difference between Directive 2001/18 and Regulation 1829/2003 is that the former is based on Art. 114 TFEU whereas the latter rests upon such a provision and others. Given that both acts are inspired by the principle of subsidiarity as Directive 2015/412, one would have expected to see Art. 2(2) in the preambles of the proposed Regulation.

68 See Art. 34a (2) of COM (2015) 177.

69 Recital n. 12.

70 Recital n. 9.

71 Ibidem.

72 COM (2015) 176, p. 7.

73 See art. 1 of Annex 1 of the TBT agreement.

74 See Art. 1 of Annex A to the SPS agreement.

75 J. Peel, 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 EJIL, 1009, 1012-1013. See Panel reports on European Communities – Measures Affecting the Approval and Marketing of Biotech Products WT/DS291/R (United States), WT/DS292/R (Canada), WT/DS293/R (Argentina), 21 November 2006, paras 7.2545-7.2922.

76 However, it is true that restrictions to use GM food and, in particular of GM feed, are likely to affect the economic interests of WTO exporters of these products to the EU more than cultivation bans, considering the limited practice of GM crops in the Member States.

77 Under this provision, SPS measures are any measure applied […]: ‘to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.’

78 I wish to thank Andrés Delgado Casteleiro for his usefeul comments on this issue.

79 A. Delgado Casteleiro, J. Larik, The ‘Odd Couple’: The Responsibility of the EU at the WTO, in M. Evans, P. Koutrakos, The International Responsibility of the European Union: European and International Perspectives, Oxford, Hart publishing, in particular the discussion at p. 238-244.

80 Ibidem, p. 240.

81 See, inter alia, Case C-73/08, Bressol [2010], ECR I-02735, par. 28. On the ring-fenced effect of this case-law on the exercise of national competence see Azoluai, L., The “Retained Powers” Formula in the Case Law of the European Court of Justice: EU Law as Total Law?, European Journal of Legal Studies, 4, Issue 2, 2011, p. 192 Google Scholar; K. Lenaerts, ‘L’encadrement par le droit de l’Union européenne des compétences des Etats membres’ in Mélanges en l’honneur du Professeur Jean Paul Jacqué (Paris, Dalloz, 2010).

82 Detailed in Recital n. 4 of the Directive.

83 Case C-77/09 Gowan Comércio Internacional e Serviços Lda c. Ministero della Salute, [2010] ECR I-13533.

84 C-58/10, cit., par. 75-77.

85 C- 333/08 Commission c. France, [2010] ECR I-00757.

86 Case 120/78, Rewe-Zentrale AG [1979], ECR 649.

87 Joined Cases C-204 to C-208/12 Essent Belgium NV v. Vlaamse Reguleringsinstantie voor de Elektriciteits- en Gasmarkt of 11 September 2014, nyr.

88 C-120/95 Decker v Caisse de maladie des employés privés, [1998] ECR I-01831.

89 C-236/01 Monsanto agricoltura italiana spa and Others v. Presidenza del Consiglio dei ministri and others [2003] ECR II-8105.

90 C- 165/2008 Commission v. Poland, [2009] ECR I-6943. In this case, the Court found that a Member State cannot rely on public morality, religious and ethical concerns in order to prohibit the circulation of genetically modified seed varieties. See paras 54-63.

91 COM (2015) 176, cit., p. 7.