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Marketing and Cultivation of GMOs in the EU

An Uncertain Balance between Centrifugal and Centripetal Forces

Published online by Cambridge University Press:  20 January 2017

Nicolas de Sadeleer
Nicolas de Sadeleer*
Affiliation:
Saint-Louis University Brussels, Université Catholique de Louvain and A Coruña University
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Extract

Due to the astounding revolution sparked off by genetic engineering, the artificial modification of the genome through targeted alterations of DNA and RNA is now competing with the traditional phenotype use of living organisms (selective plant and animal breeding, consumption, manufacturing of products, energy production, etc.). Although until recently these were insurmountable obstacles, interspecies barriers to reproduction are fading away, and it is now possible to transfer genes from one species to the genome of another. In short, the artificial genetic engineering is replacing selective breeding. Furthermore, a new age is dawning – that of synthetic biology – in which man will no longer content himself with modifying existing organisms but, thanks to the radical modification of the genome, will be able to create new cells and new organisms.

Type
Mini-Symposium on the EU GMO Reform
Information
European Journal of Risk Regulation , Volume 6 , Issue 4 , December 2015 , pp. 532 - 558
Copyright
Copyright © Cambridge University Press 2015

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References

1 SANU, L’utilisation des ressources génétiques en biotechnologie et son cadre réglementaire (Durabilitas, 2014); Winter, Gerd, “The Regulation of Synthetic Biology by EU Law”, in Giese, B. et al. (eds), Synthetic Biology (Heildelberg: Springer, 2014) p. 213 Google Scholar.

2 An organism is deemed to be genetically modified where its genetic endowment is modified in a way that cannot be achieved naturally either by multiplication or recombination. See in particular Article 2(2) of the Convention on Biological Diversity, Article 5(5)(2) of the German Federal Law of 21 March 2003 on Non Human Gene Technology, and Article L 531-1(2) of the French Environmental Code. Directive 2001/18 defines it as “any biological entity capable of replication or of transferring genetic material.” When the pollen stemming from a variety of genetically modified corn loses its capacity of reproduction and is devoid of any capacity to transfer genetic material, it does not constitute a GMO within the meaning of secondary law anymore. See Case C-442/09 Bablok [2011] ECR I-7419, para. 62.

3 Article 4(2) of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms, OJ 2001 L 106/1. The maize 5010 case epitomises the risks stemming from genes expressing resistance to antibiotics. See T-240/10, Hungary v Commission, EU:T:2013:645, para. 38.

4 EFSA Panel on Genetically Modified Organisms (GMO), « Scientific Opinion on the assessment of potential impacts of genetically modified plants on non-target organisms », 8(11) (2010) EFSA Journal 1877, 72 ppGoogle Scholar.

5 Article 4(2)(a), (d) and (e) TFEU. In virtue of Article 2(2) TFUE, the EU has the power to legislate and to adopt legally binding acts in these areas. However, Member States exercise their competence inasmuch as the EU has not exercised its own competence.

6 Although competence over such matters is shared, the area could also be subject to exclusive harmonisation if harmonised completely or exhaustively. The extent to which any harmonisation will be exhaustive will not be affected by the distinction between directives and regulations or by the fact that the harmonising measure was adopted under Article 114 TFEU or on another legal basis. E.g. P. Syrpis, ‘The Relationship between Primary and Secondary Law in the EU’ 52:2 (2015) CMLRev p. 465. See Case C-218/85 CERAFEL v Albert le Campion [1986] ECR I-1513, para. 16; Case C-255/86 Commission v Kingdom of Belgium [1986] ECR I-693, para. 10 ; T-31/07, Du Pont de Nemours (France) e.a. v Commission, EU:T:2013:267, paras. 203-205. See Christoforou, T., “GMO in EU Law”, in de Sadeleer, N. (eds), Implementing Precaution. Approaches from Nordic Countries, the EU and USA (London: Earthscan, 2007) pp. 214–215 Google Scholar.

7 The EU lawmaker has been harmonising the traceability and labelling of GMOS (Regulation 1830/2003), their transboundary movements (Regulation 1946/2003), the contained use of genetically modified micro-organisms (Directive 2009/41). By the same token, genetic therapy applied to man, as well as access to genetic resources and the sharing of benefits arising from their use, are also addressed (Regulation (EC) No 511/2014). Finally, several provisions regulate the road and rail transport of GMOs (Directives 94/55/EC, OJ 1994 L 319 and Directive 96/49/EC, OJ 1996 L 235).

8 According to the ECJ, this principle “is reflected in the different measures contained in prior authorisation, supervisory and safeguard procedures” put in place by the directive on the deliberate release into the environment of genetically modified organisms. See Case C-6/99 Greenpeace France [2000] ECR I-1676, para. 44; T-240/10, Hungary v Commission, EU:T:2013:645, para. 1; French Council of State, Assoc. Greenpeace France, 25 September 1998, n° 194348.

9 A. I. Myhr, “Uncertainty and Precaution: Challenges and Implications for Science and the Policy of GMOs”, in N. de Sadeleer (ed.), Implementing Precaution, supra note 5, pp. 186-196.

10 For an overview of secondary law, see in particular de Sadeleer, N. and Noiville, C., “La directive communautaire 2001/18/CE sur la dissémination volontaire d’organismes génétiquement modifiés dans l'environnement: un examen critique” (2002) 88 JTDE pp. 81–85 Google Scholar; Francesconi, S., “The New Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms: Changes and Perspectives” (2001) 10:3 RECIEL pp. 309–321 Google Scholar; Scott, J., “European Regulation of GMOs and the WTO” (2003) 9 ColJEurL pp. 213–239 Google Scholar; Sheridan, B., EU Biotechnology Law & Practice. Regulating Genetically Modified & Novel Food Products (Bembridge, UK: Palladian Law Publishing Ltd, 2001) p. 368 Google Scholar; Christoforou, T., “The Regulation of GMOs in the EU: The Interplay of Science, Law and Politics” (2004) 41 CMLR pp. 637–709 Google Scholar; Lee, M., EU Regulation of GMOS (Cheltenham: Elgar Publishing, 2008)CrossRefGoogle Scholar; C. Noiville, M. A. Hermitte, and E. Brosset, “Organismes génétiquement modifiés” (2009) 4100 JurisClasseur Environnement et Développement durable. ; Thieffry, P., Droit de l’environnement de l’union européenne, 2 nd edn (Bruxelles: Bruylant, 2010) pp. 547–583 Google Scholar; Brosset, E., “Le droit de l’UE relatif aux OGM : observations sur la réforme et la résistance du (au) droit”, in Mahieu, S. et Merten-Lentz, K. (coord.), Sécurité alimentaire. Nouveaux enjeux et perspectives (Bruxelles: Bruylant, 2013) p. 61 Google Scholar; Urrutia Libarona, I., “Comercialización de transgénicos y medio ambiente”, in Javier Sanz Larruga, F., García Pérez, M. and José Pernas García, J. (dir.), Libre mercado y protección ambiental. Intervención y orientación ambiental de las actividades económicas (Madrid: INAP, 2013) p. 281 Google Scholar.

11 Case C-170/94 Commission v Greece [1995] ECR I-1819; Case C-312/95 Commission v Luxemburg [1996] ECR I-5143; Case C-343/97 Commission v Belgium [1998] ECR I-4291. Regarding the transposition of Directive 2001/18: Case C-429/01 Commission v France [2003] ECR I-14355; Case C-165/08; Commission v Poland [2009] ECR I-684; Case C-478/13 Commission v Poland [2013]. For instance, the CJEU has been condemning thrice France for failing to implement correctly the Directive (see Case C-429/01 Commission v France [2003] ECR I-13909; Case C-269/127 Commission v France [2003] ECR I-14355; Case C-121/07 Commission v France [2008] ECR I-9159).

12 For several years now, the Council of State has been annulling ministerial decisions banning the placing on the market of transgenic maize. See French Council of State, Sté. Monsanto, 28 November 2011, n°312921; EARL de Commenian, 18 May 2012, n°358614, followed in substance by Assoc. Générale des producteurs de maïs, SRL Le Trouilh et EARL de Candelon, 1 August 2013, n°358103; Assoc. Générale des producteurs de maïs, SRL Le Trouilh et EARL de Candelon, 5 May 2014, n°377133.

13 OJ 1990 L 117/15. Under Directive 90/220/EEC, numerous marketing applications for GMOs had aroused objections from the Member States, which ultimately led to an almost generalised blockage of the procedure applicable to the granting of authorisations. A mere eighteen MAs were issued during this period, only three of which did not attract any objection from the Member States. This free-for-all resulted in the imposition of a de facto moratorium on 24 June 1999 on the marketing of new GMOs. However, a WTO panel reached the conclusion that the moratorium infringed the SPS Agreement. See Report of the Appellate Body of 29 September 2006 European Communities - Measures Affecting the Approval and Marketing of Biotech products WT/DS291/R, WT/DS292/R and WT/DS293/R. Regarding the vicissitudes of Directive 90/220/EEC, see M. Lee, supra note 10, pp. 2-4, 63.

14 Article 12.

15 See in this respect Regulation (EC) No 2309/93 establishing a European Agency for the Evaluation of Medicinal Products, OJ 1993 L 214; Regulation (EC) No 1829/2003 on genetically modified food and feed, OJ 2003 L 268, and Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species, OJ 2002 L 193.

16 E. Brosset, supra note 10, p. 35.

17 Council Directive 2002/53/EC, supra note 15.

18 Council Directive 92/33/EEC on the marketing of vegetable propagating and planting material, other than seed, OJ 1992 L 157/1.

19 Council Directive 2002/11/EC amending Directive 68/193/EEC on the marketing of material for the vegetative propagation of the vine and repealing Directive 74/649/EEC, OJ 2002 L 53/20. This directive provides the opportunity (subject to an assessment equivalent to that of Directive 2001/18/EC) to market genetically modified propagating material for trials, selection work and ultimately even for the production (Article 5ter bis). If products, stemming from GMO vines, are intended for use as food or food ingredient, they also fall within the scope of Regulation (EC) No 1829/2003, commented supra note .

20 Noiville, C. and de Sadeleer, N., “La gestion des risques écologiques et sanitaires à l’épreuve des chiffres. Le droit entre enjeux scientifiques et politiques” (2001) 2 RDUE pp. 389–449 Google Scholar; Joerges, C. and Ladeur, K.-H., Integrating Scientifc Expertise into Regulatory Decision-Making (Baden-Baden: Nomos, 1997)Google Scholar; Alemano, A., Trade in Food (London: Cameron & May, 2007) pp. 77–104 Google Scholar; Mahieu, S., Le droit de la société de l’alimentation (Bruxelles: Larcier, 2007) p. 674 Google Scholar.

21 Recital 47.

22 de Sadeleer, N., Environmental Principles (Oxford: OUP, 2005) pp. 112–114 Google Scholar.

23 Regarding the recourse to Article 114(5) TFEU, see Joined Cases C-439/05 P and C-454/05 P Land Oberösterreich and Republic of Austria v Commission [2007] ECR I-7441, para. 64.

24 Articles 13 to 19.

25 Article 18(1).

26 Article 5(6)(2) of the Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ 1999 L 184/23. See M. Lee, supra note 10, pp. 71.

27 The authorisations granted for maize Bt 176 and maize T 25 were withdrawn.

28 Commission Decision 2010/135/EU concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch, OJ 2010 L 53/11.

29 Hungary v Commission, supra note 3, para. 82.

30 Ibid, para. 85.

31 Ibid, para. 86.

32 Maize TC 1507 had already been authorised for import into European territory for human and animal consumption. Here we are talking about the culturing of the variety.

33 Nineteen out of twenty-eight Member States declared their opposition against the marketing of this maize variety. However, in the absence of a qualified majority (73,9% of the votes), the Council was unable to obstruct the marketing authorisation process. See M. Lee, supra note 10, pp. 63-64, 70-71.

34 Article 256 of the TFEU. 35 Article 18 of Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms, OJ 2001 L 106.

36 T-164/10, Pioneer Hi-Bred International, EU:T:2013:503, para. 42.

37 Article 18(1) of the Directive 2001/18/EC, supra note 3.

38 Pioneer Hi-Bred International, supra note 36, para. 47.

39 Ibid, para. 72.

40 Due to the absence of a qualified majority in favour or against these authorisations within the Standing Committee on the Food Chain and Animal on 23 May 2014, the Commission should soon approve the marketing for food and feed of three new varieties of transgenic soya and of one transgenic maize. These varieties are soy 305423 (Pioneer), MON 87705 (Monsanto), BPS-CV127-9 (BASF), and maize T25 (Bayer). On 24th April 2015, the Commission adopted 10 new authorisations for GMOs for food/feed use (MON 87460 maize, MON 87705 soybean, MON 87708 soybean, MON 87769 soybean, 305423 soybean, BPS-CV127-9 soybean, MON 88302, oilseed rape, T304-40 cotton, MON 88913 cotton, LLCotton25xGHB614 cotton), 7 renewals of existing authorisations (T25 maize, NK603 maize, GT73 oilseed rape, MON 531 x MON 1445 cotton, MON 15985 cotton; MON 531 cotton and MON 1445 cotton), and also the authorisation for the importation of 2 GMO cut flowers (carnations line IFD-25958-3 and line IFD-26407-2). It must be noted that these authorisations had received “no opinion” votes from Member States in both the Standing and Appeal Committees, since no qualified majority either in favour or against was expressed.

41 Commission Work Programme 2015, COM(2014) 910 final, p. 10.

42 Regulation (EC) No 1829/2003 relies on three distinct legal bases, namely Articles 37, 95 and 152(4)(b) of the EC (Articles 43, 114 and 168(4) of the TFEU).

43 Article 4.

44 Article 16.

45 Regulation (EC) No 1829/2003, supra note 15. Regarding the modalities of its application, see Commission Regulation (EC) No 641/2004 OJ 2004 L 102/14. The regulation has replaced the existing approval procedures for GM foods under the Novel Foods Regulation (EC) No 258/97, that was not entirely satisfactory. See Case C-236/01 Monsanto Agricoltura Italia [2003] ECR I-8105.

46 Recital 6. Regulation (EC) No 258/97/CE concerning novel foods and novel food ingredients provided for a simplified procedure for the placing on the market of “substantially equivalent” genetically modified food, pursuant to which several marketing authorisation had been granted. This procedure gave rise to litigation. The ECJ held that the mere presence of traces of transgenic proteins in novel foods did not prevent these foods to be considered as substantially equivalent to existing foods and, consequently, to be subject to a simplified procedure. Account must be made of the fact that foodstuffs covered by an authorisation granted pursuant to the new Regulation (EC) No 1829/2003 are now exempted from the requirements of Regulation (EC) No 258/97, unless they fall within the scope of ambit of Article 1(2)(a) of that Regulation in respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.

47 Guidance Notes from Food and Standards Agency and Department for Environment, Food and Rural Affairs on Regulation (EC) No 1829/2003 and on Regulation (EC) No 1830/2003, p. 6.

48 Bablok, supra note 2, para. 62. See Lamping, M., « Shackles for Bees ? The ECJ's Judgment on GMO-Contaminated Honey », 1(2012) EJRR pp. 123–129 Google Scholar.

49 Article 3(1)(c). As a constituent particular to honey, pollen shall, in the future, not be considered as an “ingredient” anymore within the meaning of Regulation (EC) No 1169/2011 on the provision of food information to consumers, OJ 2011 L 304/18.

50 Bablok, supra note 2, para. 79.

51 Articles 5(5) and 17(5).

52 Article 28.

53 Articles 15(4) of the Directive 2001/18/EC, supra note 3, and Articles 7(5) and 19(5) of Regulation (EC) No 1829/2003, supra note 16.

54 Article 11(1) of the Directive 2001/18/EC, supra note 3, and Article 23 of Regulation (EC) No 1829/23, supra note 15.

55 M. Weimer, ‘Risk Regulation and Deliberation in EU Administrative Governance. GMO Regulation and Its Reform’ (2015) ELJ 5.

56 For a list of the authorisations granted or the applications for permission processed by the EU, see http://www.gmo-compass.org/eng/gmo/db/.

57 So far, the EU institutions have still to deal with fifty-eight authorisation requests, which is more than the number of GMOs that have been approved in the EU thus far. However, the EFSA has already completed the risk assessment and given a favourable opinion of eighteen of them. Six varieties of cotton (five authorisation requests and one renewal application), four varieties of maize (of whom NK603, MON 87460 and the renewal application of T25), five varieties of Monsanto soybean and one variety of colza (renewal application of GT73).

58 Articles 5(3) and 33 of Regulation (EC) No 1829/23, supra note 15.

59 Monsanto Agricoltura Italia, supra note 45, paras. 78, 79 and 84.

60 A permanent scientific panel on GMOs was created within the EFSA, that is deemed to be a “European regulatory agency”. This concept is defined by the Commission as “an autonomous legal entity set up by the legislative authority in order to help regulate a particular sector at European level and help implement a Community policy.” See Draft Interinstitutional Agreement of 25 February 2005 on the Operating Framework for the European Regulatory Agencies (COM(2005) 59 final), p. 5. In 2012, the European Parliament, the Council and the Commission adopted a “common approach” to the EU decentralised agencies, which gives some guidance regarding the principles of good governance that apply to these agencies. See. Bernard, E., “Accord sur les agences européennes: la montagne accouche d’une souris” (2012) 3 RDUE pp. 399–446 Google Scholar.

61 GMOs for cultivation are to undergo an individual risk assessment before being authorised to be placed on the Union market taking into account the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects, on human health and the environment. That risk assessment provides scientific advice to inform the decision-making process and is followed by a risk management decision. The assessment is carried out in accordance with Annex II of the Directive.

62 Articles 22(7), 23, and 36 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law. See M. Weimer, supra note 55, p. 6.

63 OJ 2002 L 31/1.

64 Recital 34 of Regulation (EC) No 178/2002, supra note 63. See A. Alemano, Trade in Food, supra note 20, pp. 161-223; Ibid, “L’AESA souffle ces cinq premières bougies : un premier bilan d’activité” (2007) 3 RDUE pp. 585-632.

65 Hungary v Commission, supra note 3, para. 103. Regarding the scope of this principle in the field of food safety, see de Sadeleer, N., “Précaution et sécurité alimentaire”, in Sécurité alimentaire. Nouveaux enjeux et perspectives (Brussels: Bruylant, 2013) pp. 307–346 Google Scholar.

66 Articles 6(4) and 18(4).

67 Hungary v Commission, supra note 3, para. 91. See also by analogy Case T-326/99 Fern Olivieri/Commission and EMEA [2003] ECR II-6053, para. 55.

68 Case T-13/99 Pfizer [2002] ECR II-03305, para. 199.

69 Case C-120/97 Upjohn [1999] ECR I- 223, para. 47 ; Case C-405/92 Mondiet [1993] ECR I-6133, paras. 31-32 and 36 ; Case T-76/96 R Pfizer [1996] ECR II-815, paras. 196-201. See also Alemano, A. and Mahieu, S., “The EFSA before the European Courts” (2008) 5 EF&FLR p. 325 Google Scholar ; M. Lee, EU Regulation of GMOS, supra note 8, p. 86 ; Pintado, C., “La valeur des avis scientifiques de l’EFSA”, in Actualité en droit alimentaire (Limal: Anthémis, 2014) pp. 173 and 209-237Google Scholar.

70 The jurisdictions allow that the institutions could rely on national studies in so far the risks are regulated. In that connection, the CFI has allowed the Commission to prohibit an antibiotic, vigniamycin, on the basis of studies carried out by the Danish authorities; even if this study was in contradiction with the opinion delivered by the Standing Committee on Plants, Animals, Food and Feed. See Pfizer, supra note 69, para. 298. On the possibility of carrying out a risk assessment of a product in the light of its applications in Sweden, Norway and the United States, see Polyelectrolytes Producers Group, C-199/13, EU:C:2014:205, para. 41.

71 Pfizer, supra note 69, para. 200.

72 Case C-3/00 Kingdom of Denmark v Commission [2003] ECR I-2643, paras. 49 and 50; and Joined Cases T-366/03 and T-235/04 Land Oberösterreich [2005] ECR II-4005, paras. 41 and 43.

73 Case T-311/06 FMC Chemical and Arysta Lifesciences v EFSA [2008] ECR II-88, paras. 67-68; Case T-397/06 Dow AgroSciences v EFSA [2008] ECR II-90, paras. 59-60. See Chamon, M., “EU Risk Regulators and EU Procedural Law” (2014) 3 EJRR pp. 324–337 Google Scholar.

74 See Joined Cases T-74/00, T-76/00, T-78/00, T-132/00 and T-141/00 Artegodan [2002] ECR II-4945, para 199.

75 M. Weimer, supra note 55, p. 7.

76 Recital 7 of Directive 2015/412.

77 Whereas Directive 2001/18/EC was adopted on the basis of former Article 95 EC (Article 114 TFEU), Regulation (EC) No 1829/2003 was adopted on the basis of Articles 43, 114 and 168(4) TFUE. In contrast, Directive 2002/53/EC on the common catalogue of varieties of agricultural plant species was adopted on the basis of the CAP legal base (Article 43 TFEU). It is settled case law that the genuine environmental legal basis encapsulated in Article 192 TFEU does not alter the competences which the EU lawmaker holds under the terms of Article 114 TFEU. See de Sadeleer, N., EU Environmental Law and the Internal Market (Oxford: OUP, 2014) p. 148 Google Scholar; Ibid., « Environmental Governance and the Legal Bases Conundrum », Oxford Yearbook of European Law (2012) pp. 1–29 Google Scholar.

78 Article 22 of the Directive 2001/18/EC, supra note 3; Article 19(5) of Regulation (EC) No 1829/2003, supra note 15; Article 16(1) of the Directive 2002/53/EC, OJ 2002 L 193. See I. Urrutia Libarona, supra note 8, p. 301.

79 Case C-165/08 Commission v Poland [2009] ECR I-6843.

80 N. de Sadeleer, EU Environmental Law and the Internal Market, supra note 77, pp. 358-380.

81 Denmark v Commission, supra note 72, para. 58.

82 The CJEU held that ‘the adoption of new national legislation is more likely to jeopardise harmonization. The EU institutions could not, by definition, have taken account of the national text when drawing up the harmonization measure.’ See Case C-512/99 Germany v Commission [2003] ECR I-84, para. 41; and Denmark v Commission, supra note 72, para. 58.

83 Germany v Commission, supra note 82, para. 81; Land Oberösterreich and Austria v Commission, supra note 23, para. 57.

84 Land Oberösterreich [2005] ECR II-4005, para. 67; and Land Oberösterreich and Republic of Austria v Commission, supra note 23, paras. 65-66.

85 Ibid, para. 66.

86 Opinion AG Sharpston in Land Oberösterreich and Republic of Austria v Commission, supra note 23, para. 134.

87 Communication from the Commission concerning Article 95 (paragraphs 4, 5 and 6) of the Treaty establishing the European Community (COM(2002)760 final), para. 19.

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

89 Ibid.

90 Case C-36/11 Pioneer Hi Bred Italia [2012] OJ C355; Opinion AG Bot in Case C-36/11 Pioneer Hi Bred Italia [2012] OJ C355, para. 51.

91 Craig, P. and De Burca, G., EU Law: Text, Cases, and Material, 3 rd ed. (Oxford: OUP, 2003) p. 1186 Google Scholar.

92 Greenpeace France, supra note 8, para. 44 ; Monsanto Agricoltura Italia, supra note 45, para. 111. See de Sadeleer, N., “The Precautionary Principle in EC Health and Environmental Law” (2006) 12 European Law Journal pp. 139–172 CrossRefGoogle Scholar.

93 Case C-165/08 Commission v Poland [2009] ECR I-6843, para. 61.

94 Article 23(1) of Directive 2001/18/EC, supra note 3.

95 Article 34 of Regulation (EC) No 1829/2003, supra note 16 referring to Article 53 of Regulation (EC) No 178/2002, supra note 72.

96 Greenpeace France, supra note 8.

97 Monsanto Agricoltura Italia, supra note 45, para. 107.

98 See, by analogy, the interpretation of the safeguard clause laid down in former Regulation (EC) No 258/97, OJ 1997 L 43; Monsanto Agricoltura Italia, supra note 45, paras. 106 and f.

99 By the same token, in Biothec products the DSB panel ruled that there was sufficient scientific evidence for the Member States to perform a full risk assessment in accordance with the SPS Agreement. As a result, national authorities invoking the safeguard clauses could not have recourse to provisional measures under Article 5.7 of the SPS Agreement.

100 Article 23(1)(3) of the Directive 2001/18/EC, supra note 3; Article 54(1) of Regulation (EC) No 178/2002, supra note 62. Regarding the obligation to inform ‘immediately’ the other member States and the Commission of the interim protective measures adopted, see Cases C-58/10 to C-68/10 Monsanto and Others [2011] ECR 1-7763, para. 70.

101 In 2005, by contrast, the Council obtained the required majority to reject the European Commission proposal to lift the bans on diverse varieties of genetically modified maize and colza subject to national safeguard clauses prohibiting their cultivation and marketing in various European Union countries, such as France, Austria or Germany (maize T25 and MON810 are prohibited in Austria, maize Bt-176 is prohibited in Austria, Germany and Luxemburg, colza Topas 19/2 is prohibited in France and Greece, and colza MSI-RF1 is prohibited in France).

102 Opinion AG Bot in Joined Cases C-58/10 to C-68/10 Pioneer Hi Bred Italia [2011] ECR I-7763, para. 21.

103 Joined cases C-58/10 to C-68/10 Monsanto SAS e.a. [2011], paras. 70-71; Opinion AG Bot in Monsanto and Others, supra note 106, para. 55. See M. Weimer, “The Right to Adopt Post- Market Restrictions of GM Crops in the EU” (2012) EJRR pp. 447 and following; M. Clément “Arrêt Monsanto : Du principe de précaution au risque manifeste” (2012) REDC pp. 163 and following.

104 Monsanto and Others, supra note 103, para. 81; See G. Kalfleche, “Application du droit de l’Union par les juridictions administratives (novembre 2011- mai 2012)” (2012) 7 Europe pp. 10-11.

105 Monsanto Agricoltura Italia, supra note 45, para. 112.

106 This approach seems less ambitious then the one regarding pesticides, where the EU legislator adopted Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides, OJ 2009 L 309.

107 See the case law listed in note 11.

108 Case C-121/07 Commission v France [2008] ECR I-9159.

109 Case C-165/08 Commission v Poland [2009] ECR I-6843, para. 56.

110 I. Urrutia Libarona, supra note 10.

111 Proposal for a Regulation of the European Parliament and 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) 375 final). See. Poli, S., “The Commission's New Approach to the Cultivation of GMOs” (2012) 4 EJRR pp. 339–344 Google Scholar; Zurek, K., “Indicating Reasons for National GM Opt-Outs” 2(2011) EJRR pp. 241-3Google Scholar ; Corti Varela, J., “Opt-Out Clause in Cultivation of GMOs is closer (or not)” 3(2014) EJRR pp. 359–361 Google Scholar.

112 OJ L 68/1. The legal basis chosen is Article 114 TFEU.

113 Article 26b(1) of Directive 2015/415.

114 Article 26b(2).

115 Recital 21, and Article 26b(5).

116 Article 26b(3). The European Parliament obtained that phase 2 is not subjected to phase 1.

117 Recital 13 of Directive 2015/415.

118 Art. 26b(3)(1) Directive 2015/412.

119 G. Winter, National Cultivation Restrictions and Bans of Genetically Modified Crops and Their Compatibility with Constitutional, EU and International Law, Legal Report Commissioned by the Federal Nature Conservation Agency (May 2015) 9.

120 Recital 7 of Directive 2015/415.

121 Recital 5 of Directive 2015/415. In the same vein, experimental release control of GMOs - also commonly known as field or clinical trials -, the potential impact of which is more limited in geographical terms, falls under the competence of the national authorities (Part B of Directive 2001/18). These types of releases are mainly carried out for the purposes of study, research, demonstration and development of novel varieties.

122 Recital 17 of Directive 2015/415.

123 N. de Sadeleer, EU Environmental Law and the Internal Market, supra note 77, pp. 369-370.

124 Weimer, M., “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” 4(2010) EJRR pp. 345–352 Google Scholar.

125 Case 37/83 Rewe-Zentrale [1984] ECR 1229, para. 18 ; Case 265/65 Commission v. France [1997] ECR I-6959.

126 de Sadeleer, N. and Poncelet, C., « Protection Against Acts Harmful to Human Health and the Environment Adopted by the EU Institutions », 14 (2011-2012) Cambridge Yearbook of EU Law, pp. 177–208 CrossRefGoogle Scholar.

127 Case C-323/93 Centre d'insémination de La Crespelle [1994] ECR I-5077; Case C-249/92 Commission v Italy [1994] ECR I-4311; Case C-3/99 Cidrerie Ruwet [2000] ECR I-8749 ; and Case C-350/97 Monsees [1999] ECR I-2921, para. 27; ; Case C-309/02 Radlberger [2004] ECR I-11763, para. 53; Case C-350/97 Monsees [1999] ECR I-2921 and Case C-216/11 Commission v France [2013] ECR I-000, para. 27; Case C-216/11 Commission v France [2013] EU:C:2013:162, para. 27; Case C-573/12, Ålands vindkraft AB v Energimyndigheten, EU:C:2014:2037, para. 58.

128 Oliver, P. (ed.), Oliver on Free Movement of Goods in the EU (Oxford: Hart, 2010) p. 484 Google Scholar.

129 See the discussion above, Part II, Section 4.

130 Article 26b(3), second paragraph.

131 Case C-110/05 Trailers [2009] ECR I-519, para. 37; Case C-142/05 Mickelsson and Roos ‘Swedish Watercrafts’ [2009] ECR I-4273, para. 24.

132 Trailers, supra note 131, para. 58.

133 Case C-265/06 Commission v Portugal [2008] ECR I-2245, para. 33; Trailers, supra note 131, para. 56.

134 Mickelsson and Roos ‘Swedish Watercrafts’, supra note 131, para. 28.

135 Ibid.

136 N. de Sadeleer, EU Environmental Law and the Internal Market, supra note 77, pp. 275-278.

137 Trailers, supra note 131, para. 56; Mickelsson and Roos ‘Swedish Watercrafts’, supra note 132, paras. 26-27.

138 Case C-51/93 Schmidberger [2003] ECR I-5659, para. 78.

139 Case C-292/92 Hünermund [1993] ECR I-6787, 6813.

140 Opinion AG Bot in Ålands vindkraft AB v Energimyndigheten, C-573/12, EU:C:2014:2037, paras. 74-110.

141 Opinion AG Bot in Essent Belgium NV, C-204/12 to C-208/12, EU:C:2014:2192.

142 Joined cases C-204/12 to C-208/12, Essent Belgium NV, EU:C:2014:2192, paras. 89-116; case C-573/12, Ålands vindkraft AB v Energimyndigheten, supra note 127, paras. 76-119, annotated by M. Sydlo in 52:2 (2015) CMLRev pp. 489-510.

143 M. Sydlo, supra note 142, p. 497.

144 See, by analogy, case C-59/11 Association Kokopelli [2012] ECR, paragraph 80 and the case-law cited. See also Para 65 Bott.

145 Opinion of AG Poiares Maduro of 14 September 2004 in Case C-42/02 Commission v. Netherlands [2004] ECR I-11375, paras. 30 to 33. See also Jacobs, F.G., ‘Recent developments in the principle of proportionality in EC law’ in Ellis, E. (ed.), The Principle of Proportionality in the Laws of Europe (Oxford, Hart, 1999) 21 Google Scholar; T. Tridimas, ‘Proportionality in European Community Law: Searching for the Appropriate Standards of Scrutiny’, in The Principle of Proportionality in the Laws of Europe, above, 66; P. Kapteyn and P. VerLoren Van Themmat, above, 640; Unperath, H. and Johnston, A., ‘The Double-headed Approach to the ECJ concerning Consumer Protection’ (2007) 44 CMLR 1237–1284 Google Scholar.

146 Joined cases 80 & 81/77 Commissaires réunis [1978] ECR I-1978, para. 297; Case 15/83 Denkavit Nederland [1984] ECR I-2171, para. 15; Case C-51/93 Meyhui [1994] ECR I-3879, para. 11; and Case C-114/96 Kieffer and Thill [1997] ECR I-3629, para. 27; Case C-469/00 Ravil v. Bellon [2003] ECR I-5053, para. 86 ; C-108/01 Consorzio del Prosciutto di Pama v. Asda Stores [2003] ECR I-5121, para. 53 C434/02 Arnold André v. Herford [2004] ECR I-11825, para. 57 ; Case C-210/03 R Swedish Match [2004] ECR I-11893, para. 59 and Joined Cases C-154 and 155/04 R Alliance for Natural Health [2005] ECR I-6451, para. 47. See P. Oliver, supra note 128, pp. 60-67.

147 Opinion AG Moiares Maduro in Case C-41/02 Commission v Kingdom of the Netherlands [2004] ECR I-11378, paras. 30-33. See also Jacobs, F.G., “Recent developments in the principle of proportionality in EC law” in Ellis, E. (eds), The Principle of Proportionality in the Laws of Europe (Oxford: Hart, 1999) p. 21 Google Scholar; Tridimas, T., “Proportionality in European Community Law: Searching for the Appropriate Standards of Scrutiny”, in Ellis, E. (eds), The Principle of Proportionality in the Laws of Europe (Oxford: Hart, 1999) p. 66 Google Scholar; Unperath, H. and Johnston, A., “The Double-headed Approach to the ECJ concerning Consumer Protection” (2007) 44 CMLR pp. 1237–1284 Google Scholar; de Sadeleer, N., Commentaire Mégret. Environnement et Marché Intérieur (Brussels: ULB, 2010) p. 374 Google Scholar; Oliver, P., Oliver on Free Movement of Goods in the EU (Oxford: Hart, 2010) p. 60 Google Scholar; Barnard, C., The Substantive Law of the EU, 3 rd ed. (Oxford : OUP, 2011) p. 151 Google Scholar.

148 M. Weimer, supra note 55, p. 349; Streinz, R., Europarecht 9th ed. (Heidelberg, C. F. Müller, 2012) paras. 759 and 847Google Scholar; Craig, P, EU Administrative Law (Oxford : OUP, 2006) p. 520 CrossRefGoogle Scholar; Syrpis, P., ‘The Relationship between Primary and Secondary Law in the EU’ 52:2 (2015) CMLRev p. 484 Google Scholar. See also Verdure, C., “La libre circulation des denrées alimentaires”, in Sécurité alimentaire. Nouveaux enjeux et perspectives (Louvain: Anthemis, 2014) pp. 218–232 Google Scholar.

149 Case C-305/05 Ordre des barreaux francophones et germanophone and Others [2007] ECR I-5305, para. 28. AG Bot Opinion Bot in Ålands vindkraft AB v Energimyndigheten supra note 127, para. 64.

150 P. Syrpis, supra note 6, pp. 473-477.

151 Ibid., p. 468.

152 Ibid.

153 P. Oliver, supra note 128, pp. 251-253; Gromley, L. W., EU Law of Free Movement of Goods and Customs Union (Oxford: OUP, 2009) pp. 460–462 Google Scholar.

154 Supra note 11, para. 72.

155 C. Barnard, supra note 147, p. 152.

156 Case C-112/02 Schmidberger [2003] ECR I-5659, noted by M. Humphreys (2004) EnvLR 190-203. The Court took care to underline the Case's differences with regard to the Commission v. France Case the judgment of which was delivered on 9 December 1997.

157 Ibid, para. 93.

158 M. Weimer, supra note 55, p. 16.

159 Pursuant to Article 191(1) TFEU, the environmental policy pursues four objectives. Nothing precludes Member States to pursue additional objectives.

160 Indeed, national environmental safeguard measures environmental can be justified given that Article 192(2) TFEU permits that ‘harmonisation measures answering environmental protection requirements shall include, where appropriate, a safeguard clause allowing Member States to take provisional measures, for noneconomic environmental reasons, subject to a procedure of inspection by the Union’.

161 Opinion AG Leger in Case C-36/98 Spain v Council [2001] ECR I-779, para. 106.

162 N. de Sadeleer, supra note 77, pp. 284-301.

163 C. Blumann et al., Commentaire Mégret. PAC et PCC (Brussels : ULB, 2011) pp. 25 à 36

164 Recital 6.

165 G. Winter, supra note 119, 17.

166 Ibid.

167 See P. Oliver, supra note 128, p. 401-411.

168 Article 18 of Directive 2002/53 supra note 3; recital 4 of Directive 2015/412.

169 See the case law commented on above, supra III, 3. Land Oberösterreich supra note 23.

170 Public order may not however be invoked alone.

171 Recital 4 of Directive 2015/412.

172 S. Poli, supra note 111, p. 341.

173 Recital 3 of Directive 2015/412. However, Directive 2015/412 does not really address the role of uncertainty in the risk assessment and the cooperation between the EFSA and the national scientific authorities. According to M. Weimer, the reform puts “too much emphasis on the uniformity of the risk assessment”. M. Weimer, supra note 55, p. 16.

174 Recital 13 of Directive 2015/412.

175 Recital 2 of Directive 2015/412.

176 Pursuant to Article 5(1) of the SPS Agreement, ‘Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations.’ According to Annex A4 of that agreement a risk assessment consists of ‘The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or diseasecausing organisms in food, beverages or feedstuffs.’

177 Recital 8 of Directive 2015/412.

178 Articles 4(1)b) and 16(1)c).

179 Recital 15 of Directive 2015/412.

180 See the discussion above in Part II, section 4.

181 Article 26a of Directive 2001/18 provides only that the Member States may institute coexistence measures.

182 Commission Recommendation of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming [2003] OJ L 189/36, and Communication from the Commission to the Council and the European Parliament on the implementation of national measures on the coexistence of genetically modified crops with conventional and organic farming, (COM(2006) 104 final). See also the 2009 report of the European Commission (COM(2009) 153 final). See Lee, M., “The Governance of Coexistence Between GMOs and Other Forms of Agriculture: A Purely Economic Issue ?” 2 (2008) JEL pp. 193–212 CrossRefGoogle Scholar; Corti Varela, J., “The new Strategy on Coexistence in the 2010 European Commission Recommendation” 4(2010) EJRR pp. 353–358 Google Scholar.

183 Pioneer Hi Bred Italia, supra note 90, para. 74.

184 Bablok, supra note 2.

185 G. Winter, supra note 119, p. 18.

186 Ibid, p. 19.

187 Article 26.

188 Recital 19, and Article 7.

189 Recital 32, Article 7, and Article 19(1).

190 See also the French Environmental Code.

191 Case 7/61 Commission v Italy [1961] ECR 317; Case 288/83 Commission v Ireland [1985] ECR 1761; and Case C-324/93 Evans Medicals [1995] ECR I-563. See P. Oliver, supra note 128, p. 239-241.

192 See P. Oliver, supra note 128, p. 193-194.

193 Recital 9 of Directive 2001/18; Articles 5(3)g and 33 of Regulation (EC) No 1829/23, supra note 15.

194 Case C-165/08 Commission v Poland [2009] ECR I-6843, paras. 51-55.

195 Ibid, paras. 51-64.

196 See by the same token Case C-1/96 Compassion in World Farming [1998] ECR I-1251, para. 67.

197 Art. 26b(3)(1) Directive 2015/412.

198 Case C-331/88 Fedesa [1990] ECR I-4023, para. 13. See, to the same effect, Opinion AG Van Gerven in Cases C-312/89 Sidef Conforama and C-332/89 Marchandise [1991] ECR I-997, para. 14; and Opinion AG Poiares Maduro in Cases C-434/04 Jan-Erik Anders Ahokainen [2006] ECR I-9171, paras. 23-26.

199 G. Winter, supra 119, 11.

200 See, inter alia, Case C-108/96 Mac Quen and Others [2001] ECR I-837, paras. 33 and 34; Case 219/07 Andibel [2008] ECR I-4475, para. 31; Case 100/08 Commission v Belgium [2009] ECR I-140, para. 95; Case 110/05 Commission v Italy [2009] ECR I-519, para. 65.

201 N. de Sadeleer, EU Environmental Law, supra note 77, p. 180.

202 The Court has already recognised that the compatibility of a national measure can be assessed in the light of the two fundamental freedoms. See Case C-390/99 Canal Satélite Digital [2002] ECR I-607.

203 See in particular Case C-299/02 Commission v Netherlands [2004] ECR I-9761, para. 15; Case C-140/03 Commission v Greece [2005] ECR I-3177, para. 27.

204 Case C-384/08 Attanasio Group [2010] ECR I-2025, para. 50 and the cited case-law.

205 See by analogy, Case C-567/07 Woningstichting Sint Servatius [2009] ECR I-9021, para. 29 and the cited case-law.

206 See, inter alia, Case C-220/83 Commission v France [1986] ECR 3663, para. 20; Case C-442/02 CaixaBank France [2004] ECR I-8961, para. 21; and Case C-393/05 Commission v Austria [2007] ECR I-10195, para. 52 and the cited case-law.

207 Case C-436/00 X and Y [2002] ECR I-10829, para. 50; Case C-96/08 CIBA [2010] ECR I-2911, para. 48; Case C-400/08 Commission v Spain [2011] ECR I-1915, para. 74.

208 S. Poli, , supra note 111, p. 343.

209 Article 6(2) and Article 6(3) of Regulation (EC) No 178/2002, supra note 62.

210 As a result and especially because the safeguard clauses are interpreted in a restrictive manner by the EJC, this full harmonisation leaves the Member States with little room for manoeuvre.

211 Recitals 6 and 8 of Directive 2015/412.

212 Recital 6.

213 Ibid.