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“Breaking through the Foul and Ugly Mists of Vapours”— Regulation of Alternative Tobacco and Related Products by the New TPD and Exercise of EU Competence

Published online by Cambridge University Press:  06 March 2019

Abstract

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Directive 2014/40—the new Tobacco Products Directive—was unsuccessfully challenged in three cases, Philip Morris, Poland v. European Parliament and Council, and Pillbox 38. This Article examines provisions of the Directive relating to some alternative tobacco and related products, both in terms of exercise of EU competence and substantive regulation of these products. The main flavored tobacco products can no longer be placed on the market. Electronic cigarettes are regulated by the Directive, as the initial provisions of the Commission proposal were substantially amended. The new Tobacco Products Directive reproduced the prohibition of tobacco for oral use, already at issue in the Swedish Match and Arnold André cases, and again subject of another preliminary ruling reference by Swedish Match, the Advocate General's Opinion having concluded in its validity. The Directive also provides the possibility for Member States to prohibit categories of tobacco or related products. Parallel to its analysis of their substance in terms of health regulation, this Article considers European Union competence issues relating to these provisions and examines the adequacy of the Article 114 TFEU internal market legal basis as well as compliance with the principles of proportionality and subsidiarity.

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Articles
Copyright
Copyright © 2018 by German Law Journal GbR 

References

1 See Council Directive 89/622, on the approximation of the laws, regulations, and administrative provisions of the Member States concerning the labelling of tobacco products, 1989 O.J. (L 359) 1 (EEC).Google Scholar

2 See de Witte, B., Non-Market Values in Internal Market Legislation, in Regulating the Internal Market (N. Nic Shuibhne ed., 2006).Google Scholar

3 Legal bases: Consolidated Version of the Treaty on the Functioning of the European Union, 2016 O.J. (C 202) 1, art. 168(4)(a)-(c) and (5) [hereinafter TFEU]. Express exclusion of harmonization: now in art. 168(5) TFEU, after the added reference to tobacco and alcohol abuse in this paragraph: Treaty of Lisbon Amending the Treaty on European Union and the Treaty Establishing the European Community, Dec. 13, 2007, 2007 O.J. (C 306) 1, art. 2(127)(d)(iv).Google Scholar

4 See Directive 98/43 of the European Parliament and the Council, on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products, 1998 O.J. (L 213) 9 (EC); Case C-376/98, Germany v. European Parliament and Council, 2000 E.C.R. I-8419; Directive 2003/33 of the European Parliament and of the Council, 2003 O.J. (L 152) 16 (EC); Case C-380/03, Germany v. European Parliament & Council, 2006 E.C.R. I-11573; Directive 2001/37 of the European Parliament and of the Council, on the approximation of the laws, regulations, and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products, 2001 O.J. (L 194) 26 (EC); Case C-491/01, R (British American Tobacco (UK) Ltd) v. Sec'y of State for Health, 2002 E.C.R. I-11453; Case C-434/02, Arnold André GmbH & Co. KG v. Landrat des Kreises Herford, 2004 E.C.R. I-11825; Case C-210/03, R (Swedish Match AB and Swedish Match UK Ltd) v. Secr'y of State for Health, 2004 E.C.R. I-11893.Google Scholar

5 See Case C-66/04, United Kingdom of Great Britain v. European Parliament & Council, 2005 E.C.R. I-10553; Case C-217/04, United Kingdom v. European Parliament & Council, 2006 E.C.R. I-3771; Joined Cases C-154 and 155/04, R (Alliance for Natural Health) v. Sec'y of State for Health 2005 E.C.R. I-6451; Case C-58/08, R (Vodafone Ltd) v. Sec'y of State for Business 2010 E.C.R. I-4999; Case T-526/10, Inuit Tapiriit Kanatami v. Comm'n ECLI:EU:T:2013:215; Case C-398/13P, Inuit Tapiriit Kanatami v. Comm'n, ECLI:EU:C:2015:535; Case C-270/12, United Kingdom v. European Parliament & Council ECLI:EU:C:2014:18.Google Scholar

6 See Directive 2014/40 of the European Parliament and of the Council, on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC, 2014 O.J. (L 127) 1 (EU); Case C-547/14, R (Philip Morris Brands Sarl) v. Sec'y of State for Health, ECLI:EU:C:2016:325 (Judgment), ECLI:EU:C:2015:853 (Opinion of Advocate General Kokott); Case C-358/14, Poland v. European Parliament & Council, ECLI:EU:C:2016:323 (Judgment), ECLI:EU:C:2015:848 (Opinion); Case C-477/14, R (Pillbox 38 (UK) Ltd.) v. Sec'y of State for Health, ECLI:EU:C:2016:324 (Judgment), ECLI:EU:C:2015:854 (Opinion).Google Scholar

7 TFEU art. 168(1); TFEU art. 9; Charter of Fundamental Rights of the European Union, art. 35, Dec. 7, 2000, 2016 O.J. (C 202) 389. See T. Hervey, Community and National Competence in Health after Tobacco Advertising, 38 Common Mkt. L. Rev. 1421 (2001).Google Scholar

8 See Case C-491/01, supra note 4, at para. 62; Arnold André, Case C-434/02, supra note 4, at paras. 32-33; Swedish Match, Case C-210/03, supra note 4, at paras. 31–32; Germany, Case C-380/03, supra note 4, at paras. 39–40; Philip Morris, Case C-547/14, supra note 6, at paras. 60–61; Poland, Case C-358/14, supra note 6, at paras. 34–35.Google Scholar

9 See André, Arnold, Case C-434/02, supra note 4, at para. 35; Swedish Match, C-210/03, supra note 4, at para. 34; Germany, Case C-380/03, supra note 4, at para. 43; Philip Morris, C-547/14, supra note 6, at para. 64; Poland, Case C-358/14, supra note 6, at para. 38.Google Scholar

10 See Germany, Case C-380/03, supra note 4, at para. 42; Philip Morris, Case C-547/14, supra note 6, at para. 63; Poland, Case C-358/14, supra note 6, at paras. 37, 68–69.Google Scholar

11 See Case C-491/01, supra note 4, at para. 123; Arnold André, Case C-434/02, supra note 4, at para. 46; Swedish Match, Case C-210/03, supra note 4, at para. 48; Germany, Case C-380/03, supra note 4, at para. 145; Philip Morris, Case C-547/14, supra note 6, at para. 166; Poland, Case C-358/14, supra note 6, at para. 79; Pillbox 38, Case C-477/14, supra note 6, at paras. 49, 61, 96.Google Scholar

12 See Council Directive 89/622, supra note 1, amended by Council Directive 92/41, 1992 O.J. (L 158) 30 (EEC); Council Directive 90/239 on the approximation of the laws, regulations, and administrative provisions of the Member States concerning the maximum tar yield of cigarettes, 1990 O.J. (L 137) 36 (EEC).Google Scholar

13 See Case C-491/01, supra note 4; Arnold André, Case C-434/02, supra note 4; Swedish Match, Case C-210/03, supra note 4.Google Scholar

14 See World Health Organization Framework Convention on Tobacco Control (May. 2003), art. 11; Framework Convention on Tobacco Control Guidelines for Implementation of Article 11, Decision FCTC/COP3(10) (Nov. 2008).Google Scholar

15 See Directive 2010/13 of the European Parliament and of the Council, on the coordination of certain provisions concerning the provision of audiovisual media services, 2010 O.J (L 95) 1 (EU).Google Scholar

16 See Case C-151/17, Swedish Match AB v. Secretary of State for Health ECLI:EU:C:2018:241, Opinion of Advocate General Saugmandsgaard Øe.Google Scholar

17 See Directive 2014/40, supra note 6, at art. 7(1) subpara. 1. Article 2(25) defines characterizing flavor as “a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives …”Id. Google Scholar

18 See Directive 2014/40, supra note 6, at art. 7. Article 7(2) provides for the adoption of implementing acts by the Commission on whether a tobacco product falls within the prohibition. Id. Article 7(3) concerns implementing acts to establish uniform rules on procedures to determine whether a tobacco product has a characterizing flavor, adopted as Commission Implementing Regulation 2016/779, 2016 O.J. (L 131) 48 (EU). Id. Article 7(4) provides for implementing acts as to procedures for the independent advisory panel, adopted as Commission Implementing Decision 2016/786, 2016 O.J. (L 131) 79 (EU). Id. Google Scholar

19 See Directive 2014/40, supra note 6, at art. 7(7); see however Committee on Agriculture and Rural Development Opinion (EP) PE507.956 of 27 Jun. 2013, Amendment 39 (“regulate”).Google Scholar

20 See Directive 2014/40, supra note 6, at art. 7(6)(a), (d), added by the Council of the European Union General Approach, 11483/13 (June 24, 2013), annex, at art. 6(4)(d). Also prohibited are additives or stimulants “associated with energy and vitality” such as caffeine and taurine—Article 7(6)(b)—additives with “coloring properties for emissions”—(c)—as well as additives having CMR properties in unburnt form—(e).Google Scholar

21 See Directive 2014/40, supra note 6, at art. 7(1) subpara. 2. See however Committee on Industry, Research and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendment 5 (refers to consumer choice). Article 7(5) of Directive 2014/40 provides that the Commission may adopt delegated acts to set maximum content levels for additives resulting in a characterizing flavor, if at least three Member States have issued prohibitions.Google Scholar

22 See Directive 2014/40, supra note 6, at art. 7(1) subpara. 2. Article 7(9) subpara. 1 provides that Member States are to prohibit additives substantially increasing toxic or addictive effect and CMR properties at consumption stage, based on scientific evidence. Id. The Commission can adopt—under article 7(10)—implementing acts concerning the scope of paragraph 9, and under article 7(11) delegated acts setting maximum content levels for such additives where paragraph 9 prohibitions have been adopted in at least three Member States, at the lowest maximum level. Id. See also the prohibitions in article 7(6)(b), (d), and (e); Commission Staff Working Document Impact Assessment, SWD (2012) 452 final (Dec. 19, 2012), part 1 at 55–56, 97–104, 118, and part 5 at 7 (options envisaged).Google Scholar

23 See Directive 2014/40, supra note 6, at art. 6(1) subpara. 1 (a) and (2)(a) to (d) (toxicity/addictiveness (a), flavor (b), inhalation/nicotine uptake (c), and CMR properties (d). Article 6(1) provides for implementing acts to lay down and update the priority list of additives. Such an implementing act was adopted as Commission Implementing Decision 2016/787, 2016 O.J. (L 131) 88 (EU). See also Directive 2014/40, supra note 6, at art. 5; Directive 2001/37, supra note 4, at art. 6; Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee: First Report on the Application of the Tobacco Products Directive, at 6–7, COM (2005) 339 final (July 27, 2005); Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Second Report on the Application of the Tobacco Products Directive, at 7–8, COM (2007) 754 final (Nov. 27, 2007); Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 3–4.Google Scholar

24 See Directive 2014/40, supra note 6, at art. 7(12). The Commission may remove exemption of other tobacco product categories by delegated acts. See below on proportionality.Google Scholar

25 See Directive 2014/40, supra note 6, at art. 7(14) and art. 29(1) subpara. 2.Google Scholar

26 See Council of the European Union General Approach, supra note 20, annex, at recital 15 (“to give consumers the adequate time to switch to other products and thus to limit the risks associated with illicit trade”); Directive 2014/40, supra note 6, at recital 16 (“to allow consumers adequate time to switch to other products”).Google Scholar

27 Amendments adopted by the European Parliament on the Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, Eur. Parl. Doc. P7_TA(2013)0398 (Oct. 8, 2013), Amendments 50, 87 and 95 (art. 6(10b)) (five years from date of transposition and specific reference to menthol).Google Scholar

28 Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932, at art. 6(12) (six years from entry into force, four years from transposition).Google Scholar

29 See Poland, supra note 6, at paras. 23–25; Philip Morris, Case C-547/14, supra note 6, at question 1(c)(ii).Google Scholar

30 See however below on “capsules embedded in the filter”: Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 34, part 4 at 4, 6, 39, and 41; Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at paras. 59 and 62; Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 67 and 70.Google Scholar

31 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, at 3 and Amendment 20; Arnold André, Case C-434/02, supra note 4; Swedish Match, Case C-210/03, supra note 4.Google Scholar

32 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, at 3 and Amendment 20; Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at recital 15 (providing that “a number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people”). This recital was removed from the Directive).Google Scholar

33 See Committee on Agriculture and Rural Development Opinion (EP) PE507.956 of 27 June 2017, Amendment 6 (noting that mentholated cigarettes consumption was high in only three Member States); Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendment 19; Committee on the Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments, 7, 8, 25 (on insufficient evidence of their “bad influence on the smoking behavior among youngsters,” and time on the market, as used “in traditional tobacco products since the 1920s”), 33 (art. 2(1)(35a)) and 39.Google Scholar

34 See Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at paras. 45–47; Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 62–64.Google Scholar

35 The Advocate General added that excluding menthols would have limited the impact of the ban in achieving the high level of health protection. See Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at paras. 60–61; Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 68–69.Google Scholar

36 See Joined Cases C-465/00, C-138, and 139/01, Rechnungshof v. Österreichischer Rundfunk 2003 E.C.R. I-4989, para. 41; Case C-101/01, Bodil Lindqvist 2003 E.C.R. I-12971, para. 40; Germany, Case C-380/03, supra note 4, at para. 80.Google Scholar

37 See Österreichischer Rundfunk, Joined Cases C-465/00, C-138 and 139/01, supra note 36, at para. 41; Case C-491/01, supra note 4, at para. 60; Germany, Case C-380/03, supra note 4, at para. 80.Google Scholar

38 See World Health Organization Framework Convention on Tobacco Control Partial Guidelines for Implementation of Articles 9 and 10, Decision FCTC/COP4(10), (Nov. 2010), Decision FCTC/COP5(6), (Nov. 2012), at sec. 3.1.2.2; Directive 2014/40, supra note 6, at recitals 15–16.Google Scholar

39 Poland, Case C-358/14, supra note 6, at paras. 40–49, Opinion of Advocate General Kokott at para. 78; Philip Morris, Case C-547/14, supra note 6, at paras. 106–15, Opinion of Advocate General Kokott at para. 75.Google Scholar

40 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendments 4 and 20 (“characterizing flavors/aroma/taste other than tobacco and traditional flavors such as menthol”); Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013, Amendments 6, 8, 21, 33 (“additives that create or release a flavor which is not predominantly that of tobacco or menthol”), and 40 (art. 6(7) subpara. 1a); Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendments 4 and 23; Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendments 2, 16 (“distinctive fruity or confectionary-like taste … tobacco and menthol … not [being] considered a fruity or confectionary-like taste”), 19, and 24; Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 7, 8, 25 (“traditional tobacco products flavors such as menthol are not considered to be characterizing flavors”), and 39.Google Scholar

41 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendments 4 and 20; Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 8, 25 and 39 (“traditional”). The four years derogation based on sales volume was stressed by the Court in relation to proportionality.Google Scholar

42 See André, Arnold, Case C-434/02, supra note 4, at para. 69; Swedish Match, Case C-210/03, supra note 4, at para. 71.Google Scholar

43 See Poland, Case C-358/14, supra note 6, at paras. 50–55, Opinion of Advocate General Kokott at paras. 48–57; Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at para. 65.Google Scholar

44 See Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 34, part 4 at 6 (“Member States are also taking different legal approaches as regards additives integrated in the filter of cigarettes … Germany does not allow cigarettes with flavored capsules embedded in the filter to be placed on the market … in Belgium 3 ingredients … needed to include the “menthol capsules” in cigarettes were recently banned.”), and 39–45.Google Scholar

45 See Poland, Case C-358/14, supra note 6, at para. 57, Opinion of Advocate General Kokott at paras. 59, 62–65; Philip Morris, Case C-547/14, supra note 6, at para. 117, Opinion of Advocate General Kokott at paras. 67 and 70.Google Scholar

46 See Case C-376/98, Germany, supra note 4, at para. 86; Case C-377/98, Netherlands v. European Parliament & Council 2001 E.C.R. I-7079, para. 15; British American Tobacco, Case C-491/01, supra note 4, at para. 61; Arnold André, Case C-434/02, supra note 4, at para. 31; Swedish Match, Case C-210/03, supra note 4, at para. 30; Germany, Case C-380/03, supra note 4, at para. 38; Case C-301/06, Ireland v. EP & Council, 2009 E.C.R. I-593, para. 64; Vodafone, Case C-58/08, supra note 5, at para. 33; Inuit Tapiriit Kanatami, Case C-398/13P, supra note 5, at para. 27; Alliance for Natural Health, Joined Cases C-154 and 155/04, supra note 5, at para. 29; Poland, Case C-358/14, supra note 6, at para. 33; Philip Morris, Case C-547/14, supra note 6, at paras. 59 and 122.Google Scholar

47 See World Health Organization Framework Convention on Tobacco Control Partial Guidelines for Implementation of Articles 9 and 10, Decision FCTC/COP4(10), (Nov. 2010), Decision FCTC/COP5(6), (Nov. 2012), at sec. 3.1.2.2(i).Google Scholar

48 See Poland, Case C-358/14, supra note 6, at paras. 58–61, Opinion of Advocate General Kokott at paras. 73–82; Philip Morris, Case C-547/14, supra note 6, at paras. 118–22, Opinion of Advocate General Kokott at paras. 71–80.Google Scholar

49 The Advocate General Kokott had noted the “lively cross-border trade” when considering existing obstacles.Google Scholar

50 See Poland, Case C-358/14, supra note 6, at paras. 63 and 38; Philip Morris, Case C-547/14, supra note 6, at paras. 124 and 64.Google Scholar

51 See Case C-359/92, Germany v. Council of the European Union, 1994 E.C.R. I-3681, paras. 4 and 33; Arnold André, Case C-434/02, supra note 4, at para. 35; Swedish Match, Case C-210/03, supra note 4, at para. 34; Germany, Case C-380/03, supra note 4, at para. 43; Alliance for Natural Health Joined Cases C-154 and 155/04, supra note 5, at para. 33.Google Scholar

52 See Poland, Case C-358/14, supra note 6, at paras. 62–64, Opinion of Advocate General Kokott at paras. 39–41 and 59; Philip Morris, Case C-547/14, supra note 6, at paras. 123–25, Opinion of Advocate General Kokott at paras. 67 and 81–85. Advocate General Kokott dismissed the argument on smuggling and black-market trade.Google Scholar

53 See D. Wyatt, Community Competence to Regulate the Internal Market, Oxford Legal Stud. Res. Paper, No. 9/2007, 6–7 (referring to Council Directive 88/146, 1988 O.J. (L 70) 16 (EEC) prohibiting the use in livestock farming of certain substances having a hormonal action, based on Article 43 EEC (now art. 43 TFEU)–component of a product–and Council Directive 88/378, 1988 O.J. (L 187) 1 (EEC) concerning the safety of toys, based on Article 100a EEC (now art. 114 TFEU)–“product in its own right”. See below on the snus ban as a “prohibition outright of a product”.Google Scholar

54 See S. Crosby, The New Tobacco Control Directive: An Illiberal and Illegal Disdain for the Law, 27 Eur. L. Rev. 177, 186–87 (2002).Google Scholar

55 “Negative” and “positive” lists.Google Scholar

56 See Directive 2014/40, supra note 6, at art. 2(25).Google Scholar

57 See Directive 2014/40, supra note 6, at art. 7(2) on implementing acts determining whether a tobacco product falls within the scope of the prohibition, art. 7(3) on implementing acts providing uniform rules for procedures to determine whether a tobacco product falls within that scope, adopted as Commission Implementing Regulation 2016/779, 2016 O.J. (L 131) 48 (EU), and art. 7(5) on delegated acts setting maximum content levels, where such levels led to the adoption of national prohibitions in at least three Member States.Google Scholar

58 A point made in Philip Morris on proportionality: see Philip Morris, Case C-547/14, supra note 6, at para. 183, Opinion of Advocate General Kokott at para. 175.Google Scholar

59 See Germany, Case C-380/03, supra note 4, at para. 42; United Kingdom, Case C-66/04, supra note 5, at para. 45; United Kingdom, Case C-217/04, supra note 5, at para. 43; Vodafone, Case C-58/08, supra note 5, at para. 35; United Kingdom, Case C-270/12, supra note 5, at para. 102.Google Scholar

60 See Poland, Case C-358/14, supra note 6, at paras. 65–69, Opinion of Advocate General Kokott at paras. 66–71.Google Scholar

61 See Morris, Philip, Case C-547/14, supra note 6, at question 3(a) (on Article 7(1) and (7)); Poland, Case C-358/14, supra note 6, 2nd plea, at paras. 71–73.Google Scholar

62 See Poland, Case C-358/14, supra note 6, at para. 79; Philip Morris, Case C-547/14, supra note 6, at para. 166; Case C-491/01, supra note 4, at para. 123; Arnold André, Case C-434/02, supra note 4, at para. 46; Swedish Match, Case C-210/03, supra note 4, at para. 48; Germany, Case C-380/03, supra note 4, at para. 145; Alliance for Natural Health, Joined Cases C-154 and 155/04, supra note 5, at para. 52; Vodafone, Case C-58/08, supra note 5, at para. 52.Google Scholar

63 See Germany, Case C-359/92, supra note 51, at paras. 4 and 33; Arnold André, Case C-434/02, supra note 4, at para. 35; Swedish Match, Case C-210/03, supra note 4, at para. 34; Germany, Case C-380/03, supra note 4, at para. 43; Alliance for Natural Health, Joined Cases C-154 and 155/04, supra note 5, at para. 33. The Court referred to its ruling on the legal basis. See above on prohibition of flavors and methods of approximation, below on oral tobacco.Google Scholar

64 See above on the absence of specificity of the menthol flavor.Google Scholar

65 See World Health Organization Framework Convention on Tobacco Control Partial Guidelines for Implementation of Articles 9 and 10, Decision FCTC/COP4(10), (Nov. 2010), Decision FCTC/COP5(6), (Nov. 2012), at sec. 3.1.2.2(i); Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 35.Google Scholar

66 See Morris, Philip, Case C-547/14, supra note 6, at paras. 170–77, 64, and 124–25; Poland, Case C-358/14, supra note 6, at paras. 80–86, 89, 38 and 63–64; Opinion of Advocate General Kokott at para. 100.Google Scholar

67 See Poland, Case C-358/14, supra note 6, at paras. 71, 83 and 87; Opinion of Advocate General Kokott at paras. 101-103.Google Scholar

68 See Poland, Case C-358/14, supra note 6, at para. 88; Opinion of Advocate General Kokott at paras. 105-108.Google Scholar

69 The AG noted the immateriality of proving scientifically with sufficient accuracy health effects of the prohibition of mentholated cigarettes, in light of the precautionary principle, and the possibility of adopting restrictive measures in the presence of insufficient studies, but of a “likelihood of real harm to public health,” as apparent in the Partial Guidelines for Implementation of Articles 9 and 10, at sec. 3.1.2.2(i).Google Scholar

70 See Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at paras. 92–98 and 78; Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 155–60 and 75. As in Pillbox 38, a sub-section was devoted to the precautionary principle in the Poland v EP and Council Opinion.Google Scholar

71 See World Health Organization Framework Convention on Tobacco Control Partial Guidelines for Implementation of Articles 9 and 10, Decision FCTC/COP4(10), (Nov. 2010), Decision FCTC/COP5(6), (Nov. 2012), at sec. 3.1.2.2(i) and 1.1.Google Scholar

72 See Appellate Body, WTO Doc. AB-2012-1, WT/DS406/AB/R (“United States — Measures affecting the production and sale of clove cigarettes.”); see also C. Pitschas, The New EU Tobacco Products Directive and the Regulation of Tobacco Products with a Characterizing Flavor, 20 Int'l Trade L. & Reg. 60 (2014) (on the compatibility of Directive 2014/40, supra note 6, art. 7(1) with the TBT Agreement, menthol flavor and lists of additives); Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendments 19 and 32.Google Scholar

73 Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at recital 15.Google Scholar

74 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 3.Google Scholar

75 See Directive 2014/40, supra note 6, at art. 7(12). The Commission may by delegated act withdraw the exemption for a product category, in the presence of a “substantial change of circumstances as established in a Commission report”.Google Scholar

76 See Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, at 3 and Amendment 6; Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, Amendment 78.Google Scholar

77 See Morris, Philip, Case C-547/14, supra note 6, at paras. 178–79, Opinion of Advocate General Kokott at paras. 163–70; Poland, Case C-358/14, supra note 6, at paras. 90–91, Opinion of Advocate General Kokott at paras. 112– 17; M. Elsmore & V. Obolevich, Thank You for Not Smoking: The Commission's Proposal for a New Tobacco Products Directive, 38 Eur. L. Rev. 552, 562 (2013).Google Scholar

78 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 3 and 9.Google Scholar

79 In Poland, Case C-358/14, supra note 6, Advocate General Kokott referred to the help of family, friends and acquaintances. The Advocate General referred to age limits for the purchase/sale of such products, while the Court referred to both age limits for consumption and purchase/sale of such products.Google Scholar

80 See Pitschas, supra note 72. Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013, Amendment 32 (possibility for the Commission to adopt a negative list of additives resulting in a characterizing flavor excluding the “traditional use of menthol”).Google Scholar

81 See Directive 2014/40, supra note 6, at art. 7(3), on implementing acts as to procedural rules for determining whether a tobacco product falls within the scope of the prohibition, adopted as Commission Implementing Regulation 2016/779. See also the possibility, or obligation at the request of a Member State, to adopt implementing acts on whether a tobacco product falls within the scope of the prohibition, under Article 7(2), and delegated acts on maximum contents levels for additives resulting in a characterizing flavor, if three or more Member States adopt prohibitions, under Article 7(5)).Google Scholar

82 See Poland, Case C-358/14, supra note 6, at paras. 92–96, Opinion of Advocate General Kokott at paras. 118– 23; Philip Morris, Case C-547/14, supra note 6, at paras. 180–84, Opinion of Advocate General Kokott at paras. 171–75.Google Scholar

83 Protocol (No 2) on the Application of the Principles of Subsidiarity and Proportionality, art. 5., Dec. 13, 2007.Google Scholar

84 See Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 114, part 6 at 2.Google Scholar

85 The undertaking having made these allegations had moreover been consulted during the process.Google Scholar

86 See Case C-508/13, Estonia v. European Parliament & Council, ECLI:EU:C:2015:403, at para. 39.Google Scholar

87 See Poland, Case C-358/14, supra note 6, at paras. 97–103, 73, Opinion of Advocate General Kokott at paras. 125–35; Philip Morris, Case C-547/14, supra note 6, at paras. 185–90, Opinion of Advocate General Kokott at paras. 176–83. Having acknowledged temporary effects on farmers, manufacturers, suppliers, and marketing undertakings, the Advocate General noted in both opinions the possibility of support to farmers from the common agricultural policy, and, in Poland, Case C-358/14, supra note 6, assessed losses to the Polish agriculture and tobacco trade as “relatively moderate and manageable,” considering these were limited to declines in sales, not including net profit losses. On socio-economic concerns as to the tobacco growing, production and distribution sectors: Committee on Agricultural and Rural Development Opinion Amendments, (EP) PE507.956 of 27 June 2013, at 3, and Amendments 2 (recital 6a), 7 (recital 15a), 18 (recital 40a), 20 (recital 43a), 74-76 (article 23(2) subpara. 1 (ca)-(cb)); Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, at 3; Committee on International Trade Opinion (EP) PE510.734 of 27 May 2013, Amendment 12; Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 11, 97–98, 100, 102, 115, 120–23, part 2 at 4, part 3 at 8, part 6 at 8–11 and 36.Google Scholar

88 See Morris, Philip, Case C-547/14, supra note 6, question 7, on Directive 2014/40, supra note 6, art. 7, 8(3), 9(3), 10(l)(g), 13 and 14.Google Scholar

89 See Morris, Philip, Case C-547/14, supra note 6, at paras. 47-53, Opinion of Advocate General Kokott at paras. 48–52. The referring court had not provided reasons in its order for reference as to why art. 7, 8(3), 9(3), 10(l)(g), 13 and 14 failed to comply with the principle of subsidiarity.Google Scholar

90 See Poland, Case C-358/14, supra note 6, 3rd plea, at para. 105. See above on the presence of national divergences on flavors and menthol capsules.Google Scholar

91 See Vodafone, Case C-58/08, supra note 5, at paras. 77–78; Estonia, Case C-508/13, supra note 86, at paras. 46– 48.Google Scholar

92 See above on the absence of special of status of the menthol flavor–similar characteristics and effects. The Advocate General Kokott also noted in both opinions the need to assess compliance with subsidiarity of the Directive as a whole: Estonia, Case C-508/13, supra note 86, at para. 51.Google Scholar

93 See Estonia, Case C-508/13, supra note 86, at paras. 53–54.Google Scholar

94 The Member States were Poland, Slovakia, and Finland.Google Scholar

95 See Poland, Case C-358/14, supra note 6, at paras. 114–21, Opinion of Advocate General Kokott at paras. 149– 60; Philip Morris, Case C-547/14, supra note 6, at paras. 218–24, Opinion of Advocate General Kokott at paras. 277–85.Google Scholar

96 See Estonia, Case C-508/13, supra note 86, at para. 61; Case C-185/83, IIE der Rijksuniversiteit te Groningen v. Inspecteur der Invoerrechten en Accijnzen te Groningen, 1984 E.C.R. 3623, para. 38, and subsequent case-law.Google Scholar

97 See Philip Morris, Case C-547/14, supra note 6, at paras. 225-227; Poland, Case C-358/14, supra note 6, at paras. 122–25; Estonia, Case C-508/13, supra note 86, at para. 62.Google Scholar

98 See Directive 2014/40, supra note 6, recital 60.Google Scholar

99 This is the case considering the very nature of Article 114 TFEU, approximating national provisions. See Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 45 (on labelling and ingredients).Google Scholar

100 The statement of reasons is “not required to go into every relevant point of fact and law” and its assessment not limited to wording but including also the “context and the whole body of legal rules governing the matter in question”: see Case C-466/93, Atlanta Fruchthandelsgesellschaft mbH v. Bundesamt für Ernährung und Forstwirtschaft, 1995 E.C.R. I-3799, para. 16.Google Scholar

101 See Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 45–46.Google Scholar

102 See Philip Morris, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 286–301; Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at paras. 172–88. See also S. Weatherill, The Limits of Legislative Harmonization Ten Years After Tobacco Advertising: How the Court's Case Law Has Become a ‘Drafting Guide', 12 German L.J. 827, 845 (2011) (on recitals’ “assertion rather than demonstration” and “mechanical recitation”; regarding the Court's subsidiarity and proportionality assessments: “the problem … lies in the nature of the principles themselves, not in lenient judicial review”).Google Scholar

103 See Directive 2001/83 of the European Parliament and of the Council, 2001 O.J. (L 311) 67 (EC) on the Community code relating to medicinal products for human use. See also Commission Staff Working Document Impact Assessment, supra note 22, at part 4 at 1–2 (on Directive 2001/83, Council Directive 93/42, 1993 O.J. (L 169) 1 (EEC) concerning medical devices, as well as Regulation 178/2002 of the European Parliament and of the Council, 2002 O.J. (L 31) 1 (EC) 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, Regulation 258/97 of the European Parliament and of the Council, 1997 O.J. (L 43) 1 (EC) concerning novel foods and novel food ingredients, Directive 2001/95 of the European Parliament and of the Council 2002 O.J. (L 11) 4 (EC) on general product safety. See also Union legislation listed in Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 74 (annex Ia); Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 73 (annex IIb).Google Scholar

104 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 18(1)(a)-(c), with the possibility under art. 18(2) for the Commission to update by delegated acts nicotine quantities in light of scientific developments and authorizations granted under Directive 2001/83, supra note 103; Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 52-53, 77-84 and 117-118, part 5 at 4 (on the various policy options and impacts considered in the impact assessment).Google Scholar

105 See A. Alemanno, EU Tobacco Control 2.0, Politico.eu (Sept. 1, 2013); C. Bates, Amending the Tobacco Products Directive—How to Fix the Harm Reduction Agenda, CliveBates.com (April 22, 2013). Note the requirement of a high level of health protection in mainstreaming provisions. A similar point was made in relation to the prohibition of snus, this time not by the classification/authorization of the product, but more radically by the ban of the product itself.Google Scholar

106 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 65 (art. 18(1), (1a)(1b) “nicotine-containing products that are presented as having properties for treating or preventing disease in human beings”); Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendment 55 (“if nicotine containing products are presented as having properties for treating or preventing disease”).Google Scholar

107 See Directive 2001/83, supra note 103, art. 1(2) subpara. 1 (defining a medicinal product inter alia as “any substance or combination of substances presented for treating or preventing disease in human beings”).Google Scholar

108 See Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013, Amendment 69 (referring to the high level of health protection); TFEU art. 168(7).Google Scholar

109 See Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, Amendments 34, 33, and 71; Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendments 13, (“regulated either under the upcoming review of the pharmaceutical package or by virtue of a specific legal instrument … may include provisions allowing the placing on the market of lower-risk nicotine containing products … provided they feature an appropriate health warning”), 14 and 65.Google Scholar

110 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, at 4, Amendments 16 and 59.Google Scholar

111 See Council of the European Union General Approach, supra note 20, annex, at art. 18(1).Google Scholar

112 See Amendments adopted by the European Parliament, P7_TA(2013)0398, supra note 27, Amendments 170, 165, 118 and 137/REV on recitals (EP Partial Vote); Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932, at art. 18a; Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendments 12-14.Google Scholar

113 See Directive 2014/40, supra note 6, at art. 30(b) (transitional provision that allowed the placing on the market until 20 May 2017 of “electronic cigarettes or refill containers manufactured or released for free circulation before 20 November 2016”).Google Scholar

114 See Directive 2001/83, supra note 103; Directive 93/42, supra note 103; Directive 2014/40, supra note 6, at art. 20(1) subpara. 2.Google Scholar

115 See Directive 2014/40, supra note 6, at art. 20(3)(b).Google Scholar

116 See Directive 2014/40, supra note 6, at art. 20(3)(a), 20(3)(c)-(g). Article 20(13) provides for the adoption of an implementing act on technical standards for the refill mechanism preventing leakage, adopted as Commission Implementing Decision 2016/586, 2016 O.J. (L 101) 15 (EU).Google Scholar

117 See Directive 2014/40, supra note 6, at art. 20(4)(a)(i)-(iv) (requiring information as to use and storage, reference to young people/non-smokers, contra-indications, specific risk group warnings, adverse effects, addictiveness/ toxicity, and contact details).Google Scholar

118 See Directive 2014/40, supra note 6, at art. 13(1)(a) (alongside tar and carbon monoxide).Google Scholar

119 See Directive 2014/40, supra note 6, at art. 20(4)(b)(i) (list of ingredients, nicotine content, delivery per dose, batch number, and recommendation to keep out of reach of children).Google Scholar

120 See Directive 2014/40, supra note 6, at art. 20(4)(b)(ii) (referring to article 13, except article 13(1)(a) on nicotine and 13(1)(c) on flavorings).Google Scholar

121 See Directive 2014/40, supra note 6, at art. 20(4)(b)(iii) (“This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers,” or the simplified formula “This product contains nicotine which is a highly addictive substance”); Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932, at art. 18a(4)(b)(iii).Google Scholar

122 See Directive 2014/40, supra note 6, at art. 20(12).Google Scholar

123 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 18(3) (“This product contains nicotine and can damage your health”); Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 59 (“This product contains nicotine and damages your health.”); Council of the European Union General Approach, supra note 20, annex, at art. 18(3) (“This product contains nicotine which is an addictive substance and can damage your health.”); Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 65 (“This product contains nicotine which is addictive and may damage your health.”); Amendments adopted by the European Parliament, P7_TA(2013)0398, supra note 27 (EP Partial Vote), Amendment 170 (“This product is intended for use by existing smokers. It contains nicotine which is a highly addictive substance.“).Google Scholar

124 Bates, supra note 105.Google Scholar

125 See Directive 2014/40, supra note 6, at art. 20(4)(c) (referring to article 12(2) on smokeless tobacco products), and art. 12(2) subpara. 2(b) (30% of the two largest surfaces of the packet and outside packaging, 32% or 35% if two or more official languages).Google Scholar

126 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 18(3); Directive 2014/40, supra note 6, at art. 20(4)(b)(iii). See also the requirement that the health warning be “factual” in Article 20 on adaptation of their wording by delegated acts.Google Scholar

127 See Blasi & Ward, Electronic Nicotine Delivery Systems (ENDS): The Beginning of the End or the End of the Beginning, 44 Eur. Respiratory J. 585, 585–86 (2014); Nitzkin, The Case in Favor of E-Cigarettes for Tobacco Harm Reduction, 11 Int. J. Env. Res. and Pub. Health 6459 (2014); Public Health England, E-Cigarettes: A Developing Public Health Consensus (July, 2016), at 1, www.gov.uk.Google Scholar

128 U.S. Dep't of Health and Hum. Services, E-Cigarette Use Among Youth and Young People—A Report of the Surgeon General (CDC 2016), at 116; Oh & Kacker, Do Electronic Cigarettes Impart a Lower Potential Disease Burden than Conventional Tobacco Cigarettes?, 124 Laryngoscope 2702, 2703–04 (2014); Goniewicz et al., Levels of Selected Carcinogens and Toxicants in Vapor from Electronic Cigarettes, 23 Tob Control 133 (2014); Farsalinos et al., Tobacco-Specific Nitrosamines in Electronic Cigarettes, 12 Int'l Journal of Envl. Research & Pub. Health 9046 (2015).Google Scholar

129 Oh and Kacker, supra note 128, at 2704 (2014); U.S. Dep't of Health, supra note 128, at 101; Santanam et al., Nicotinic Acetylcholine Receptor Signaling in Atherogenesis, 225 Atherosclerosis 264 (2012); Benowitz & Burbank, Cardiovascular Toxicity of Nicotine, 26 Trends in Cardiovascular Med. 515 (2016).Google Scholar

130 U.S. Dep't of Health, supra note 128, at 100–03; McNeill et al., E-Cigarettes: An Evidence Update (Public Health England, 2015), at 71, 75; Vansickel & Eissenberg, Effective Nicotine Delivery After Acute Administration, 15 Nicotine & Tob. Res. 267 (2013); Yan & D'Ruiz, Effects of Using Electronic Cigarettes on Nicotine Delivery and Cardiovascular Function, 71 REG. Toxicology and Pharmacology 24 (2015); Bhatnagar, E-Cigarettes and Cardiovascular Disease Risk, 10 Current Cardiovascular Risk Reps. 24 (2016); St. Helen et al., Nicotine Delivery, Retention and Pharmacokinetics from Various Electronic Cigarettes, 111 Addiction 535 (2016).Google Scholar

131 Bekki et al., Carbonyl Compounds Generated from Electronic Cigarettes, 11 Int'l J. of Envtl. Res. & Pub. Health 11192, 1194–95, 1197 (2014); U.S. Dep't of Health, supra note 128, at 117–18; IARC, List of Classifications (2016); Uchiyama et al., Determination of Carbonyl Compounds Generated from the E-Cigarette, 29 Analytical Sci. 1219 (2013); Goniewicz et al., supra note 128; DeJarnett et al., Acrolein Exposure is Associated with Increased Cardiovascular Disease Risk, 3 J. Am. Heart Assoc. (2014).Google Scholar

132 See Report from the Commission to the European Parliament and the Council on the Potential Risks to Public Health Associated with the Use of Refillable Electronic Cigarettes COM (2016) 269 final (May 20, 2016), at 7; Bekki et al., supra note 131, at 11195–97; U.S. Dep't of Health, supra note 128, at 100, 117–18; Kosmider et al., Carbonyl Compounds in Electronic Cigarette Vapors - Effects of Nicotine Solvent and Battery Output Voltage, 16 Nicotine & Tob. Res. 1319 (2014); Jensen et al., Hidden Formaldehyde in E-Cigarette Aerosols, 372 New England J. Med. 392 (2015); Talih et al., Effects of User Puff Topography, Device Voltage, and Liquid Nicotine Concentration on Electronic Cigarette Nicotine Yield, 17 Nicotine & Tob. Res. 150 (2015); Geiss et al., Correlation of Volatile Carbonyl Yields Emitted by E-Cigarettes with the Temperature of the Heating Coil 219 Int'l J. Hygiene & Envtl. Health 268 (2016); Sleiman et al., Emissions from Electronic Cigarettes: Key Parameters Affecting Release of Harmful Chemicals, 50 Envtl. Sci. & Tech. 9644 (2016); Directive 2014/40, supra note 6, at art. 20(3)(a) (on volumes limits).Google Scholar

133 Bekki et al., supra note 131, at 11197; Kosmider et al, supra note 132; Oh & Kacker, supra note 128; U.S. Dep't of Health, supra note 128, at 115; Offermann, Chemical Emissions from E-Cigarettes, 93 Building & Env. 101 (2015).Google Scholar

134 U.S. Dep't of Health, supra note 128, at 119; Williams et al., Metal and Silicate Particles Including Nanoparticles are Present in Electronic Cigarette Cartomizer Fluid and Aerosol, 8 Plos One (2013); Mikheev et al., Real-Time Measurement of Electronic Cigarette Aerosol Size Distribution and Metals Content Analysis, 18 Nicotine & Tob. Research 1895 (2016).Google Scholar

135 Golli et al., Impact of E-Cigarette Refill Liquid Exposure on Rat Kidney 77 REG. TOXICOLOGY & PHARMACOLOGY 109 (2016); Golli et al., Impact of E-Cigarette Refill Liquid with or Without Nicotine on Liver Function, 26 Toxicology Mechanisms & Methods 419 (2016).Google Scholar

136 See Report from the Commission to the European Parliament and the Council on the Potential Risks to Public Health Associated with the use of Refillable Electronic Cigarettes COM (2016) 269 final (May 20, 2016).Google Scholar

137 See Directive 2014/40, supra note 6, at art. 20(11) and recital 46.Google Scholar

138 U.S. Dep't of Health, supra note 128, at 100, 102–03; Kandel & Kandel, A Molecular Basis for Nicotine as a Gateway Drug, 371 New England J. Med. 932 (2014); Nides et al., Nicotine Blood Levels and Short-Term Smoking Reduction with an Electronic Nicotine Delivery System, 38 Am. J. Health Behav. 265 (2014); Vansickel and Eissenberg, supra note 130; Dawkins and Corcoran, Acute Electronic Cigarette Use: Nicotine Delivery and Subjective Effects in Regular Users, 231 Psychopharmacology 401 (2014); Talih et al., supra note 132; Yan and D'Ruiz, supra note 130; Ramôa et al., Electronic Cigarette Nicotine Delivery Can Exceed That of Combustible Cigarettes, 25 Tob. Control (2016); St.Helen et al., supra note 130; see Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 18(1)(c) (on maximum peak plasma concentration).Google Scholar

139 On the developing adolescent brain, synaptic change, myelination, and evolving nicotinic acetylcholine receptors, see U.S. Dep't of Health, supra note 128, at 102 and 104–05; England et al., Nicotine and the Developing Human: A Neglected Element in the Electronic Cigarette Debate 49 AM. J. PREVENTIVE MED. 286 (2015); O'Loughlin et al., The Nicotine Dependence in Teens Study 44 INT'L J. EPIDEMIOLOGY 1537 (2015); Yuan et al., Nicotine and the Adolescent Brain 593 J. PHYSIOLOGY 3397 (2015).Google Scholar

140 Zhu et al., Four Hundred and Sixty Brands of E-Cigarettes and Counting: Implications for Product Regulation, 23 BMJ 3, 3–5 (2014).Google Scholar

141 Action on Smoking and Health, Use of Electronic Cigarettes (Vaporizers) Among Adults in Great Britain, 2–3 (2016 Factsheet No. 33) (noting that the estimated number of electronic cigarette users tripled in Britain between 2012 and 2014 (700,000 to 2.1 million), and increased from 2.1 to 2.8 million between 2014 and 2016. The percentage of ex-smokers in Britain using electronic cigarettes increased from 4.5% to 8.4% between 2014 and 2016, but the number of current smokers, which had increased from 2.7% to 17.6% between 2010 and 2014, did not increase between 2014 and 2015, and only increased from 17.6% to 19.4% between 2015 and 2016. They note, however, that “use among never smokers remains negligible and [in 2016] has not changed since 2012” in Britain).Google Scholar

142 McNeill et al., supra note 130, at 53–56.Google Scholar

143 Harrell et al., E-Cigarettes and Expectancies: Why Do Some Users Keep Smoking?, 110 Addiction 1833 (2015).Google Scholar

144 ASH, supra note 141, 4 (noting that 22% of smokers also using e-cigarettes used both products “to help deal with situations where [they] cannot smoke … 41% of dual users to reduce but not stop smoking, and 35% to stop completely, while 67% of ex-smokers and current vapers used electronic cigarettes to stop entirely); U.S. Dep't of Health, supra note 128, 53–55. Electronic cigarettes are, however, often also banned in public places. Directive 2014/40, supra note 6, at recital 48 (noting that the Directive “does not harmonize the rules on smoke-free environments”).Google Scholar

145 Action on Smoking and Health, Use of Electronic Cigarettes Among Children in Great Britain, 1-2 (2016 Factsheet No. 34) (showing that regular use among children surveyed—ages 11 to 18—amounted to 2%—1% more than once a month and 1% more than once a week—including 5% of current smokers for monthly and 13% for weekly use, 1% of ex-smokers for both monthly and weekly use, but 0% of never smokers for both monthly and weekly use); Britton and Bogdanovica, Electronic Cigarettes – A Report Commissioned by Public Health England (2014), 8 Pub. Health England, supra note 127, at 1; U.S. Dep't of Health, supra note 128, at 28–30, 43—46; Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 27.Google Scholar

146 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Rated Products, supra note 27, at art. 18(1).Google Scholar

147 Bates, C., The Case for Regulating E-Cigarettes as Medicines, CliveBates.com (July 6, 2013).Google Scholar

148 See Amendments adopted by the European Parliament, P7_TA(2013)0398, supra note 27 (EP Partial Vote), Amendment 170, art. 18(3)(h).Google Scholar

149 See C. Bates, Tobacco Products Directive: After The Insurrection—What Next?, CliveBates.com (Aug 31, 2013).Google Scholar

150 See Directive 2014/40, supra note 6, at recital 47 (provided such prohibitions are justified and notified).Google Scholar

151 See Directive 2014/40, supra note 6, art. 20(4)(b)(ii), (referring to article 13(1)(c) on flavorings, alongside article 13(1)(a) on nicotine content).Google Scholar

152 ASH, supra note 141, at 12 (noting that in Britain in 2016, a majority of vapers preferred tobacco flavor (33%), yet an important proportion of vapers chose fruit flavors (22%) and menthol or mint flavor (also 22%), while a limited proportion preferred vanilla (3%) or sweet and candy flavors (also 3%)); C. Bates, Tobacco Products Directive, E-Cigarettes and Snus, CliveBates.com (June 27, 2013).Google Scholar

153 Blasi and Ward, supra note 127, at 585 (2014); McNeill et al., supra note 130, at 54; Bates, supra note 147; U.S. Dep't of Health, supra note 128, at 115. Fruit flavors were popular among young people—ages 11 to 18—in 2016, both regular users (36%) and those having tried but not currently using electronic cigarettes (49%), while sweet flavors were relatively popular for the latter (13%) but not as much for regular users (7%)): see ASH, supra note 145, at 4–5. See also Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 27; Directive 2014/40, supra note 6, at recital 47 (referring to young people and non-smokers, although noting benefits of Member States allowing flavored products).Google Scholar

154 Zhu et al., supra note 140, at 3 (referring to 7764 flavors and 242 new flavors each month on English language websites at the beginning of 2014 and noting the large number of brands selling e-cigarettes online).Google Scholar

155 ASH, supra note 141, at 10 (use of devices with refillable tanks increased from 41% to 71% between 2014 and 2016 in Britain, while those with pre-filled cartridges decreased from 47% to 23%, with more ex-smokers than smokers using the former—81% and 63% respectively—and more smokers than ex-smokers using the latter—29% and 16%); Zhu et al., supra note 140, at 3–5; ASH, supra note 145, at 4 (noting that similarly, for young people— ages 11 to 18—55% used devices with refillable tanks and 13% those with pre-filled cartridges).Google Scholar

156 See Report from the Commission to the European Parliament and the Council on the Potential Risks to Public Health Associated with the use of Refillable Electronic Cigarettes, COM (2016) 269 final (May 20, 2016), at 6; U.S. Dep't of Health, supra note 128, at 115–16, 184; Barrington-Trimis et al., Flavorings in Electronic Cigarettes: An Unrecognised Respiratory Health Hazard?, 312 Jama 2493 (2014); Farsalinos et al., Evaluation of Electronic Cigarette Liquids and Aerosol for the Presence of Selected Inhalation Toxins, 17 Nicotine & Tob. Res. 168 (2014).Google Scholar

157 See Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 26, part 4 at 2 and 15–22 (on differences in national legislation).Google Scholar

158 See Case C-304/01, Spain v. Commission of the European Communities, 2004 E.C.R. I-7655, para. 31; Arnold André, Case C-434/02, supra note 4, at para. 68; Swedish Match, Case C-210/03, supra note 4, at para. 70; Case C-344/04, R (IATA) v. Department of Transport, 2006 E.C.R. I-403, para. 95; Case C-558/07, R (S.P.C.M. SA) v. Secretary of State for the Environment, Food and Rural Affairs, 2009 E.C.R. I-5783, para. 74; Case C-579/13, P and S v. Commissie Sociale Zekerheid Breda, ECLI:EU:C:2015:369, para. 41.Google Scholar

159 See Pillbox 38, Case C-477/14, supra note 6, at para. 33–45, Opinion of Advocate General Kokott at para. 36– 52.Google Scholar

160 See Case C-491/01, supra note 4, at para. 123; Arnold André, Case C-434/02, supra note 4, at para. 46; Swedish Match, Case C-210/03, supra note 4, at para. 48; Germany, Case C-380/03, supra note 4, at para. 145.Google Scholar

161 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report, FCTC/COP6(10), at para.2 (Nov. 2014).Google Scholar

162 See P. Koutrakos, Reviewing Harmonization: The Tobacco Products Directive Judgments, 41 Eur. L. Rev. 305, 305 (2016) (noting that, given the division of the scientific community on electronic cigarettes, “interference by the Court with the substantive policy choice of the EU legislature to impose restrictions would have amounted to an extraordinary and unwarranted display of activism”).Google Scholar

163 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report, FCTC/COP6(10), at paras. 2 and 23–24 (Nov. 2014).Google Scholar

164 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report, FCTC/COP6(10), at para. 14 (Nov. 2014).Google Scholar

165 See Directive 2014/40, supra note 6, at recital 43 (“gateway to nicotine addiction … mimic and normalize the action of smoking”).Google Scholar

166 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report FCTC/COP6(10), at paras. 23–24 (Nov. 2014).Google Scholar

167 Pillbox stressed, however, their lower levels in e-cigarettes than in tobacco products, and recognized the need for further scientific studies).Google Scholar

168 See Pillbox 38, Case C-477/14, supra note 6, at paras. 47–56, Opinion of Advocate General Kokott at paras. 61– 67 (the Advocate General devoted a sub-section to the precautionary principle); Case C-157/14, Société Neptune Distribution v. Ministre de l'Economie et des Finances, ECLI:EU:C:2015:823, paras. 81-82; Case C-269/13P, Acino AG v. Commission, ECLI:EU:C:2014:255, paras 57–58.Google Scholar

169 See Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 25–26, part 4 at 2; Directive 2014/40, supra note 6, at recital 36; Committee on Proposal on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, at 79.Google Scholar

170 As regards compliance with the principle of subsidiarity, the Court referred to its proportionality assessment of Article 20 as a whole and paras. 2, 3, 4(a) and 5 as to the existence of national differences: see Pillbox 38, Case C-477/14, supra note 6, at paras. 142-151.Google Scholar

171 See Directive 2014/40, supra note 6, at recital 43; World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report FCTC/COP6(10), at para. 27(a) (Nov. 2014); Case C-491/01, supra note 4, at para. 64, Opinion of Advocate General Geelhoed at para. 61, on tobacco.Google Scholar

172 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems, Decision FCTC/COP6(9), at para. 4 (Oct. 2014).Google Scholar

173 See Pillbox 38, Case C-477/14, supra note 6, at paras. 57–61.Google Scholar

174 See Pillbox 38, Case C-477/14, supra note 6, at paras. 62–66. As regards the absence of proportionality assessment of the provisions on electronic cigarettes in the impact assessment, as not initially envisaged in the Commission proposal, the Court noted the lack of binding nature of impact assessments: see Case C-343/09, Afton Chemical Limited v. Secretary of State for Transport, 2010 E.C.R. I-7027, para. 57. It also stressed the discretion of the Union legislature to adopt different measures to those envisaged in the impact assessment, including stricter measures, without manifestly exceeding what was necessary to achieve the objective pursued. The Court noted that scientific evidence and opinions of the parties had been taken into consideration by the Union legislature, and that consultations and meetings had taken place later, organized by the Commission and the ENVI Committee. Pillbox 38, Case C-477/14, supra note 6, at paras. 64-66, Opinion of AG Kokott at paras. 68-72.Google Scholar

175 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Draft EP Legislative Resolution, Amendments 15 (recital 35a) and 65 (art. 18(1e)); Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 59 (art. 18(1e)) (on a minimum age for nicotine-containing products).Google Scholar

176 See Amendments adopted by the European Parliament, P7_TA(2013)0398, supra note 27 (EP Partial Vote), Amendment 36 (recital 35a).Google Scholar

177 See Directive 2014/40, supra note 6, recital 48 (on electronic cigarettes and refill containers), and recital 21, (encouraging Member States to “lay down and enforce age limits” for tobacco and related products).Google Scholar

178 See Directive 2014/40, supra note 6, at art. 20(2) subpara. 2 (including information as to ingredients and emissions (b), toxicological data (c), nicotine doses/ uptake (d), product components (e), production process (f)).Google Scholar

179 Or six months prior to the transposition deadline for products already on the market: see Directive 2014/40, supra note 6, at art. 20(2) subpara. 1. This subparagraph also provides for a new notification “for each substantial modification of the product”.Google Scholar

180 See Directive 2014/40, supra note 6, at recital 36.Google Scholar

181 See Directive 2014/40, supra note 6, at art. 20(13), providing for the adoption of an implementing act establishing a common notification format, adopted as Commission Implementing Decision 2015/2183, 2015 O.J. (309) 15 (EU); Pillbox 38, Case C-477/14, supra note 6, at paras. 69–80, Opinion of Advocate General Kokott at paras. 75–94.Google Scholar

182 See Directive 2014/40, supra note 6, at art. 20(7) subpara. 1(iv).Google Scholar

183 See Pillbox 38, Case C-477/14, supra note 6, at paras. 132–41, Opinion of Advocate General Kokott at paras. 149–55.Google Scholar

184 See Directive 2014/40, supra note 6, at art. 20(3)(a)-(b).Google Scholar

185 See Directive 2014/40, supra note 6, at art. 1 (referring to the mainstreaming provision and young people).Google Scholar

186 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 18(1)(c).Google Scholar

187 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems Report FCTC/COP6(10), at para. 14 (Nov. 2014).Google Scholar

188 See Directive 2014/40, supra note 6, at art. 20(3)(f).Google Scholar

189 See Pillbox 38, Case C-477/14, supra note 6, at paras. 81–102 and 36–43, Opinion of Advocate General Kokott at paras. 95-112.Google Scholar

190 See Pillbox 38, Case C-477/14, supra note 6, at paras. 103–08, Opinion of Advocate General Kokott at paras. 113–19.Google Scholar

191 See Directive 2014/40, supra note 6, at art. 20(4)(a)(ii)-(iv).Google Scholar

192 See Directive 2014/40, supra note 6, at art. 20(4)(a)(v) (“addictiveness and toxicity”). Article 2(27) defines toxicity as “the degree to which a substance can cause harmful effects in the human organism, including effects occurring over time, usually through repeated or continuous consumption or exposure.”Google Scholar

193 See Directive 2014/40, supra note 6, at art. 20(4)(b)(i).Google Scholar

194 See Directive 2014/40, supra note 6, at art. 20(2) subpara. 2(b) (“list of all ingredients contained in, and emissions resulting from the use of, the product”), (c) (“toxicological data regarding the product's ingredients and emissions, including when heated”), and (e) (“description of the components of the product, including … the opening and refill mechanism”). Article 20(8) subpara. 1 requires that information be “made publicly available on a website.”Google Scholar

195 See Directive 2014/40, supra note 6, at art. 20(9) subparas. 1 (“system for collecting information about all of the suspected adverse effects on human health of these products”) and 3 (“may also request additional information … for example on the safety and quality aspects or any adverse effects”), applying to manufacturers, importers and distributers; Directive 2014/40, supra note 6, recital 45.Google Scholar

196 See Directive 2014/40, supra note 6, at art. 20(10); Report from the Commission to the European Parliament and the Council on the Potential Risks to Public Health Associated with the use of Refillable Electronic Cigarettes COM (2016) 269 final (May 20, 2016).Google Scholar

197 See Directive 2014/40, supra note 6, at art. 20(11), if such prohibitions have been adopted by at least three Member States (subpara. 2); Directive 2014/40, supra note 6, at recital 46.Google Scholar

198 See Directive 2014/40, supra note 6, art. 20(7) (on submission of market data by manufacturers and importers including “preferences of various consumer groups, including young people, non-smokers and the main types of current users” (ii)), recital 44, article 28(2) subpara. 1(g) (Commission report to “pay special attention to … market developments … including on the initiation of consumption … by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavors”).Google Scholar

199 See Directive 2014/40, supra note 6, at recital 43, (stating that “electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalize the action of smoking,” justifying a “restrictive approach” to advertising, referring to the high level of health protection).Google Scholar

200 See Directive 2014/40, supra note 6, at recital 48, as well as age limit. It also provides that the “presentation and advertising of those products should not lead to the promotion of tobacco consumption or give rise to confusion with tobacco products”.Google Scholar

201 See Directive 2014/40, supra note 6, at recital 43.Google Scholar

202 See Germany, Case C-376/98, supra note 4, at para. 102; Directive 98/43, supra note 4, at art. 3(2). See below on bans.Google Scholar

203 See Germany, Case C-376/98, supra note 4, at paras. 15–16 and 97–99; Directive 98/43, supra note 4, at art. 3(1); Germany, Case C-380/03, supra note 4, at paras. 53–54, 59 and 70–71; Directive 2003/33, supra note 4, at art. 3.Google Scholar

204 See Germany, Case C-376/98, supra note 4, at paras. 101, 104; Germany, Case C-380/03, supra note 4, at paras. 73–75; Directive 2003/33, supra note 4, at art. 8.Google Scholar

205 See Directive 2014/40, supra note 6, at art. 20(5)(a), except for “publications that are intended exclusively for professionals in the trade of electronic cigarettes or refill containers and for publications which are printed and published in third countries, where those publications are not principally intended for the Union market”). See the equivalent provisions for tobacco advertising: Directive 2003/33, supra note 4, at art. 3.Google Scholar

206 See Directive 2014/40, supra note 6, at art. 20(5)(b); Directive 2003/33, supra note 4, art. 3.Google Scholar

207 See Directive 2014/40, supra note 6, at art. 20(5)(e); Directive 2010/13 2010 O.J. (L 95) 1 (EU).Google Scholar

208 See Directive 2014/40, supra note 6, at art. 20(5)(c); Directive 2003/33, supra note 4, at art. 4(2).Google Scholar

209 See Directive 2014/40, supra note 6, at art. 20(5)(d); Directive 2003/33, supra note 4, at art. 5(1).Google Scholar

210 See Committee on Legal Affairs, Opinion on the Legal Basis of the Proposal (EP) PE527.873 of 24 Jan. 2014, at 1-3 and 5; Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932; Directive 2003/33, supra note 4; Directive 2010/13, supra note 207.Google Scholar

211 See World Health Organization Framework Convention on Tobacco Control Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems, Decision FCTC/COP6(9), at para. 3 (Oct. 2014).Google Scholar

212 See Directive 2014/40, supra note 6, at recital 43.Google Scholar

213 See Pillbox 38, Case C-477/14, supra note 6, at paras. 109–18, Opinion of Advocate General Kokott at paras. 120–33.Google Scholar

214 See Pillbox 38, Case C-477/14, supra note 6, at sub-question 4 and para. 153.Google Scholar

215 See Pillbox 38, Case C-477/14, supra note 6, at paras. 152–66, Opinion of Advocate General Kokott at paras. 181–201.Google Scholar

216 See Directive 2014/40, supra note 6, at art. 18(1) 1st sentence; Commission Staff Working Document Impact Assessment, supra note 22, at part 4 at 45–58 (on national provisions as to cross-border sales).Google Scholar

217 See Council of the European Union General Approach, supra note 20, annex, at recital 30, and art. 16(1).Google Scholar

218 See Directive 2014/40, supra note 6, at recital 33.Google Scholar

219 See Directive 2014/40, supra note 6, at art. 18(1) 4th and 5th sentences (for retail outlets established in the EU, to national authorities of the Member States where it is established and where its consumers are located; for retail outlets established outside the EU, to those of the Member States where its consumers are located).Google Scholar

220 See Directive 2014/40, supra note 6, at art. 18(4); Council Recommendation 2003/54, sec. 1(d), 2003 O.J. (L 22) 31 (EC) (recommending the adoption of national measures “to prevent tobacco sales to children and adolescents, including … restricting tobacco distance sales for general retail, such as sales via the Internet, to adults by using adequate technical means”).Google Scholar

221 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 16(1) 1st and 2nd sentences and art. 16(4); Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 45 (on the analysis of subsidiarity as regards internet distance sales).Google Scholar

222 See Commission Proposal for a Directive of the European Parliament and of the Council on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning the Manufacture, Presentation and Sale of Tobacco and Related Products, supra note 27, at art. 16; Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 56–57, 104–07, 119, part 5 at 8 (on policy options and impacts) part 4 at 7. On public health derogations to the freedom to provide information society services between Member States: Directive 2000/31, art. 3(2) and 3(4)(a)(i) point 2, 2000 O.J. (L 178) 1 (EC) on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market.Google Scholar

223 See Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013, at 4, Amendments 13 and 65-66; Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendments 7, 13, 45; Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 14, 23 and 51. The Committees refer to the prohibition of cross-border distance sales alongside that of distribution of free or discounted tobacco products through distance sales and “in public places for promotional purposes”, as well as bartering/ swapping. See also Directive 2003/33, supra note 4, at art. 5(2) (prohibiting free distribution in the context of event sponsorship), and the general ban of free distribution promoting tobacco products in article 3(4) of the annulled Directive 98/43 1998 O.J. (L 213) 9 (EC)); Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, Draft EP Legislative Resolution/ P7_TA(2013)0398 (EP partial vote), Amendments 29, 45, 68 and 69 (art. 16a).Google Scholar

224 See Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, Amendments 29 and 79; Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013 at 4, Amendments 13, and 65–66; Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, at 3-4; Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013 Amendment 7; Council of the European Union General Approach, supra note 20, annex, at recital 30; Directive 2014/40, supra note 6, at recital 33; Commission Staff Working Document Impact Assessment, supra note 22, at part 1 at 36–37, 42, 56, 105–07, part 4 at 8 (on different national provisions on internet sales); Guidelines for Implementation of Article 13, WHO FCTC, Decision FCTC/COP3(12) paras. 18–21 (Nov. 2008).Google Scholar

225 Council, Press Release 17905/13, at 2; Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932, at art. 16(1).Google Scholar

226 See Poland, Case C-358/14, supra note 6, at para. 94.Google Scholar

227 See Morris, Philip, Case C-547/14, supra note 6, at paras. 37–41.Google Scholar

228 See Morris, Philip, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 40–43, nonetheless addressed by the Advocate General; Pillbox 38, Case C-477/14, supra note 6, Opinion of Advocate General Kokott at paras. 134–48 (on Directive 2014/40, supra note 6, at art. 18 and 20(6).Google Scholar

229 See Directive 2014/40, supra note 6, at recital 33. The Advocate General noted that prohibition of cross-border distance sales was “the price for the circulation in the European internal market of [compliant] tobacco products”). See also Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 44–45, 56, 104–07, part 3 at 11–12.Google Scholar

230 See Case C-491/01, supra note 4, at para. 82; Germany, Case C-376/98, supra note 4, at para. 100 (“provisions which do not contribute to the elimination of obstacles to exercise of the fundamental freedoms”); Case C-180/96, United Kingdom v. Commission of the European Communities,1998 E.C.R. I-2265, para. 109 (on the common agricultural policy).Google Scholar

231 See Case C-491/01, supra note 4, at paras. 81–91; United Kingdom, Case C-180/96, supra note 230, at para. 109 (on animals and meat in the context of the BSE crisis, and risks as to reimports of meat and deflections of trade).Google Scholar

232 See Germany, Case C-376/98, supra note 4, at paras. 99–100.Google Scholar

233 See Morris, Philip, Case C-547/14, supra note 6, at paras. 127-131, Opinion of Advocate General Kokott at paras. 133–34 and 136–39.Google Scholar

234 See Commission Staff Working Document Impact Assessment, supra note 22, part 4 at 8 (prohibition: France and Lithuania; authorization: Austria, Bulgaria, Hungary, Latvia, and Spain).Google Scholar

235 See Directive 2014/40, supra note 6, at art. 18(1)-(5).Google Scholar

236 See Case C-37/83, Rewe-Zentral AG v. Direktor der Landwirtschaftskammer Rheinland, 1984 E.C.R. 1229, para. 20; Philip Morris, Case C-547/14, supra note 6, at paras. 63, 134 (“harmonization only in stages” and “gradual abolition of unilateral measures”).Google Scholar

237 See Morris, Philip, Case C-547/14, supra note 6, at paras. 132–36, Opinion of Advocate General Kokott at para. 135.Google Scholar

238 See Directive 2014/40, supra note 6, at recital 33.Google Scholar

239 See Inuit Kanatami, Tapiriit, Case C-398/13P, supra note 5, at para. 29; Case C-5/67, Beus GmbH & Co v. Hauptzollamt München, 1968 E.C.R. 125, para. 95, and additional subsequent case-law on the duty to state reasons.Google Scholar

240 See Pillbox 38, Case C-477/14, supra note 6, at paras. 129–30, Opinion of Advocate General Kokott at paras. 135–39.Google Scholar

241 See Pillbox 38, Case C-477/14, supra note 6, at paras. 120–28, Opinion of Advocate General Kokott at paras. 140–47.Google Scholar

242 See Council Directive 92/41, art. 1(5), 1992 O.J. (L 158) 30 (EEC), amending Council Directive 89/622 1989 O.J. (L 359) 1 (EEC) on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products.Google Scholar

243 See Directive 2001/37 2001 O.J. (L 194) 26 (EC); Article 151 of the Act of Accession of Austria, Finland and, Sweden O.J. 1994 C 241/3.Google Scholar

244 See Directive 2014/40, supra note 6, at art. 7(15) and (12); Amendments adopted by the European Parliament, P7_TA(2013)0398, supra note 27 (EP Partial Vote), Amendments 17, 28 (recital 29a–“there is no cross-border interest in regulating the content of snus … responsibility for regulating the content of snus lies with the Member State where snus is permitted”) 50, 87 and 95 (Article 6(10c) and 6(10)—initially substituting smokeless tobacco with waterpipe tobacco, consumed by young people); Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013, Amendments 17, 28, 50 and at 78; Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 26 (art. 18(1e)); Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 39; Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendment 6 (distinguishing oral from nasal and chewing smokeless tobacco, confined to few European regions and consumed by older people); Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendment 3 (excluding nasal tobacco, consumed by older people); Council Doc 11483/13, General Approach, annex, recital 18; Amendments by the European Parliament to the Commission Proposal, AM\P7_AMA(2013)0276(190-190) – (EP) PE515.932, art. 6(12a) and (10).Google Scholar

245 See Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013 Amendment 44.Google Scholar

246 See Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendments 10 and 62 (“This ban should, however, not affect traditional products for oral use, which may be allowed by individual Member States on cultural or historical grounds.”); Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendment 11.Google Scholar

247 See Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013 Amendment 64.Google Scholar

248 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 49, 50 (art. 15(1a)-1b)) and 72 (annex Ila - NNN, NNK, B(a)P limits, based on WHO Technical Report No. 955 toxicity recommendations, subject to adaptation by delegated acts). On the diversity of smokeless tobacco in terms of TSNA: see SCENIHR, see Health Effects of Smokeless Tobacco Products (2008), at 119; WHO Study Group on Tobacco Product Regulation, Report on the Scientific Basis of Tobacco Product Regulation (2009), at 26–29, 32–34, 36.Google Scholar

249 See Directive 2014/40, supra note 6, at art. 2(5) (defining “smokeless tobacco product” as a “tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use”); Directive 2001/37, supra note 4, art. 5(4) subpara. 1.Google Scholar

250 See Directive 2001/37, supra note 4, art. 5(5) subpara. 1 (“not less than”); Directive 2014/40, supra note 6, at art. 12(2) subpara. 2(b) (30% of the surfaces, increased to 32% or 35% for Member States with two or three more languages).Google Scholar

251 See Directive 2001/37, supra note 4, art. 5(4) subpara. 2; Directive 2014/40, supra note 6, at art. 12(2) subpara. 2(a).Google Scholar

252 See Directive 2001/37, supra note 4, art. 5(4) subpara. 1 (“This tobacco product can damage your health and is addictive.”); Directive 2014/40, supra note 6, at art. 12(1) (“This tobacco product damages your health and is addictive”, subject to adaptation by delegated acts under article 12(3)).Google Scholar

253 The Tobacco and Related Products Regulations 2016, c. 507 (Eng.), http://www.legislation.gov.uk/uksi/2016/507/contents/made.Google Scholar

254 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 3 and 17–19. Articles 1 and 7 CFREU concern respectively human dignity and respect for private and family life, article 35 CFREU constitutes the health care mainstreaming provision.Google Scholar

255 See Commission Report on the Public Consultation on the Possible Revision of the Tobacco Products Directive, at 11–13, 2001/37 (July 2011).Google Scholar

256 See Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 22–24, 50–52, 61–76, 117, part 5 at 3 (on the various options and their impacts).Google Scholar

257 See Directive 2014/40, supra note 6, at art. 19–20; C. Bates, A Strong Case to Overturn the EU Snus Ban, Clivebates.com (July 4, 2016).Google Scholar

258 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 4–5, 89.Google Scholar

259 See Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendment 44 (art. 2.1, 2.2, TBT Agreement, art. I and III GATT).Google Scholar

260 On the inappropriateness of the then Article 133 EC—now art. 207 TFEU—as a secondary legal basis yet validity of the measure, as in British American Tobacco: see Swedish Match, Case C-210/03, supra note 4, at paras. 43–44.Google Scholar

261 See André, Arnold, Case C-434/02, supra note 4, at paras. 32–33; Swedish Match, Case C-210/03, supra note 4, at paras. 31–32.Google Scholar

262 See André, Arnold, Case C-434/02, supra note 4, at para. 35; Swedish Match, Case C-210/03, supra note 4, at para. 34; Germany, Case C-359/92, supra note 51, at paras. 4, 33; Germany, Case C-380/03, supra note 4, at para. 43; Alliance for Natural Health, Joined Cases C-154 and 155/04, supra note 5, at para. 33.Google Scholar

263 The Court also noted the likelihood of future obstacles considering “the public's growing awareness of the dangers to health of the consumption of tobacco products”. See Arnold André, Case C-434/02, supra note 4, at para. 38, 40; Swedish Match, Case C-210/03, supra note 4, at paras. 37, 39.Google Scholar

264 See Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 62; Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at para. 23.Google Scholar

265 Some Member States have banned chewing and nasal tobacco: see Commission Staff Working Document Impact Assessment, supra note 22, part 4 at 2. Directive 2014/40, supra note 6, at art. 2(8) (defines oral tobacco as “all tobacco products for oral use, except those intended to be inhaled or chewed”).Google Scholar

266 Wyatt, supra note 53, at 7 (on Council Directive 88/378 1988 O.J. (L 187) 1 (EC) concerning the safety of toys or Council Directive 92/59 1992 O.J. (L 228) (24) (EC) on general product safety, based on Article 100a (now art. 114 TFEU). However, see Advocate General Geelhoed on other smokeless tobacco products.Google Scholar

267 Wyatt, supra note 53, at 25–26. Germany, Case C-376/98, supra note 4, at para. 102 (on diversification products).Google Scholar

268 See Arnold André, Case C-434/02, supra note 4; Swedish Match, Case C-210/03, supra note 4, at para. 78. See however paragraph 79 on the improvement of internal market conditions not being required “in respect of every individual product” and the argument as to “diminish[ed] enforcement costs and … even diminish[ed] … of the enforcement of regulations on related products … if snus is not on the market … the effort to control the marketing of other smokeless tobacco products can be reduced.” The Union legislature and the Court provided no such justification, yet even such an interpretation of the prohibition “as part of a wider regime dedicated to freeing trade in other kinds of products which were regarded as less harmful,” rather than as a “free standing ban,” is problematic as “it invites strategic drafting … it encourages the drafting of legislative measures that are broad not targeted.” See Weatherill, supra note 102, at 836–37.Google Scholar

269 Britton & Bogdanovica, supra note 145, at 11; Luo et al., Oral Use of Swedish Moist Snuff (Snus) and Risk for Cancer of the Mouth, Lung, and Pancreas, 369 Lancet 2015 (2007); Hansson et al., Use of Snus and Acute Myocardial Infarction, 27 Eur. J. Epidemiology 771 (2012); Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 64–65 (more generally on smokeless tobacco products).Google Scholar

270 Coggins et al., The In Vitro Toxicology of Swedish Snus, 42 Critical Rev. Toxicology 304 (2012); Osterdahl et al. Decreased Levels of Tobacco-Specific N-Nitrosamines in Moist Snuff, 52 J. Agri. & Food Chemistry 5085 (2004); Colilla, An Epidemiologic Review of Smokeless Tobacco Health Effects and Harm Reduction Potential, 56 Reg. Toxicology & Pharmacology 197 (2010); Lee, Summary of the Epidemiological Evidence Relating Snus to Health, 59 Reg. Toxicology & Pharmacology 197 (2011).Google Scholar

271 Britton and Bogdanovica, supra note 145, at 11; Foulds et al., Effect of Smokeless Tobacco (Snus) on Smoking and Public Health in Sweden, 12 Tob. Control 349 (2003); Stegmayr et al., The Decline of Smoking in Northern Sweden, 33 Scandinavian J. Pub. Health 321 (2005); Commission, Special Eurobarometer 385, Attitudes of Europeans Towards Tobacco (2012); Rodu and Cole, Lung Cancer Mortality: Comparing Sweden with Other Countries in the European Union, 37 Scandinavian J. Pub. Health 481 (2009).Google Scholar

272 See André, Arnold, Case C-434/02, supra note 4, at paras. 44 and 52; Swedish Match, Case C-210/03, supra note 4, at paras. 46, 54.Google Scholar

273 See André, Arnold, Case C-434/02, supra note 4, at para. 46; Swedish Match, Case C-210/03, supra note 4, at para. 48; Case C-491/01, supra note 4, at para. 123; Germany, Case C-380/03, supra note 4, at para. 145.Google Scholar

274 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 28-30, 40-42, 47-48, 50 and 57.Google Scholar

275 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 22, 58, 60; Directive 2014/40, supra note 6, at recitals 8, 21; Council Directive 92/41, at recitals 3, 13, 15; Arnold André, Case C-434/02, supra note 4, at para. 47; Swedish Match, Case C-210/03, supra note 4, at para. 49.Google Scholar

276 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 24–7, 43, 16, 34.Google Scholar

277 See André, Arnold, Case C-434/02, supra note 4, at paras. 49-51; Swedish Match, Case C-210/03, supra note 4, at paras. 51–53; Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 32–33.Google Scholar

278 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 35–43.Google Scholar

279 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 43–50, 57.Google Scholar

280 See Pillbox 38, Case C-477/14, supra note 6, at paras. 50–55 and 60; Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 51–57.Google Scholar

281 The Advocate General noted the objective of the new TPD to ensure the high level of health protection “for the population as a whole [rather than] in relation to a single category of consumers”, as stressed in Philip Morris and Poland v EP and Council: see Philip Morris, Case C-547/14, supra note 6, at para. 176; Poland, Case C-358/14, supra note 6, at para. 86.Google Scholar

282 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 58–63. The Advocate General also refuted Swedish Match's argument as to a “zero risk” requirement that snus be harmless for lifting its prohibition, resulting from a misinterpretation of the case-law—absence of risk evaluation and of “threshold of certainty” as to their probability and gravity—and of the rationale behind the Union legislature's decision to ban the product—presence of “demonstrated/ duly assessed” risks of a harmful character rather than proven harmlessness): paras. 64–68.Google Scholar

283 See Commission Staff Working Document Impact Assessment, supra note 22, part 4 at 2. Five Member States have banned chewing tobacco: Greece, Ireland, Latvia, Lithuania, and Poland; two Member States have banned nasal tobacco: Latvia and Lithuania.Google Scholar

284 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 70–77.Google Scholar

285 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 80–83.Google Scholar

286 See Vodafone, Case C-58/08, supra note 5, at paras. 53 and 69.Google Scholar

287 See Morris, Philip, Case C-547/14, supra note 6, at para. 156, Opinion of Advocate General Kokott at paras. 183, 209; Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott, at para. 134.Google Scholar

288 See Morris, Philip, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 179, 193, 204; Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at para. 130; Pillbox 38, Case C-477/14, supra note 6, Opinion of Advocate General Kokott at paras. 130, 190.Google Scholar

289 See Swedish Match AB, Case C-151/17, supra note 16, Opinion of Advocate General Saugmandsgaard Øe at paras. 84–88.Google Scholar

290 See also the possibility under Article 24(2) to maintain/adopt further packaging requirements on grounds of public health, other exception to the Article 24(1) free movement clause. Article 24(2) and (3) require taking into account the high level of protection of human health).Google Scholar

291 See TFEU art. 114(5) (“problem specific to that Member State”—environment or working environment); TFEU art. 114(8) (“specific problem on public health”).Google Scholar

292 Implicit in art. 114(6) TFEU subpara. 1: R. Verheyen, “Article 95 EC Treaty in Practice: The European Commission Decisions on Creosote, Sulphite, Nitrates and Nitrites”, 9 Reciel 71, 75 (2000).Google Scholar

293 See TFEU art. 114(6), at subparas. 1–2.Google Scholar

294 See Morris, Philip, Case C-547/14, supra note 6, at question 1(b), Opinion of Advocate General Kokott at para. 122.Google Scholar

295 See Morris, Philip, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at paras. 39, 41–43. The question was nonetheless examined by the Advocate General.Google Scholar

296 See Morris, Philip, Case C-547/14, supra note 6, at paras. 37–41.Google Scholar

297 The Advocate General referred to the prohibition of flavors.Google Scholar

298 The Court thus alluded to TFEU art. 168(7).Google Scholar

299 See Directive 2014/40, supra note 6, at recital 48.Google Scholar

300 See Dougan, M., Minimum Harmonization and the Internal Market, 37 Common Mkt. L. Rev. 853 (2000).Google Scholar

301 Justification given in the preamble for the contested provision: see Directive 2014/40, supra note 6, at recital 54.Google Scholar

302 See TFEU art. 114(8) (providing that “when a Member State raises a specific problem on public health in a field which has been the subject of prior harmonization measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council”); TFEU art. 114(10) (stipulating that “harmonization measures … shall, in appropriate cases, include a safeguard clause authorizing the Member States to take, for one or more of the non-economic reasons referred to in article 36, provisional measures subject to a Union control procedure”).Google Scholar

303 As with Directive 2014/40, supra note 6, at art. 24(2) (on packaging standardization).Google Scholar

304 See Morris, Philip, Case C-547/14 at paras. 85–92; Opinion of Advocate General Kokott at paras. 121–29.Google Scholar

305 See Morris, Philip, Case C-547/14 at paras. 93–94; Opinion of Advocate General Kokott at paras. 130–31.Google Scholar

306 On use of the case-law formulations by the Union legislature to draft TFEU art. 114 measures, see Weatherill, supra note 102.Google Scholar

307 See Poland, Case C-358/14, supra note 6, at para. 35; Philip Morris, Case C-547/14 at para. 61; TFEU art. 168(1) and 114(3).Google Scholar

308 See Poland, Case C-358/14, supra note 6, at para. 102–TFEU art. 114(3); Philip Morris, Case C-547/14 at para. 190–Charter of Fundamental Rights, art. 35, Dec. 7, 2000, 2016 O.J. (C 202) 389; TFEU art. 9, 114(3) and 168(1).Google Scholar

309 See Pillbox 38, Case C-477/14, supra note 6, at paras. 61 and 116–Charter of Fundamental Rights, art. 35, Dec. 7, 2000, 2016 O.J. (C 202) 389; TFEU art. 9, 114(3) and 168(1).Google Scholar

310 See Poland, Case C-358/14, supra note 6, at para. 34; Philip Morris, Case C-547/14 at para. 60.Google Scholar

311 See Poland, Case C-358/14, supra note 6, at paras. 105 and 116–18; Philip Morris, Case C-547/14, supra note 6, at paras. 214 and 220–22.Google Scholar

312 See Poland, Case C-358/14, supra note 6, at paras. 37 and 68-69; Philip Morris, C-547/14, supra note 6, at para. 63.Google Scholar

313 See Poland, Case C-358/14, supra note 6, at para. 79; Philip Morris, Case C-547/14, supra note 6, at para. 166.Google Scholar

314 See Pillbox 38, Case C-477/14, supra note 6, at paras. 49, 61, 96.Google Scholar

315 For a general discussion of mainstreaming provisions, the EU legislature's discretion/broad discretion, public health legal basis, as well as provisions on labelling and packaging, see Abaquesne de Parfouru, Choking Smokers Don't You Think The Joker Laughs At You’ – European Union Competence and Regulation of Tobacco Products Packaging under the New Tobacco Products Directive, Maastricht J. Eur. & Comp. L. (forthcoming).Google Scholar

316 See Morris, Philip, Case C-547/14, supra note 6, Opinion of Advocate General Kokott at para. 301; Poland, Case C-358/14, supra note 6, Opinion of Advocate General Kokott at para. 188.Google Scholar

317 FCTC Partial Guidelines for Implementation of Articles 9 and 10, Decision FCTC/COP4(10) and Decision FCTC/COP5(6).Google Scholar

318 See Wyatt, supra note 53.Google Scholar

319 See Committee on International Trade Opinion (EP) PE510.734 of 19 June 2013, Amendments 8, 11; Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 2 and 15; Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013, at 3, 4, Amendments 3 and 14; Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendment 18; Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013/P7_TA(2013)0398 (EP partial vote), Amendments 4 and 40; See Guidelines for the Implementation of Article 12 of the WHO FCTC (Education, Communication, Training and Public Awareness), Decision FCTC/COP4(7).Google Scholar

320 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 2; Committee on Agricultural and Rural Development Opinion (EP) PE507.956 of 27 June 2013 Amendment 3; Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013, Amendment 18; Committee on Proposal on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013/P7_TA(2013)0398 (EP partial vote), Amendment 40; Directive 2014/40, supra note 6, at art. 10(1)(b) (on smoking cessation information, which constitutes part of the combined health warnings). See also the amendment proposed by the European Parliament ITRE Committee of combined health warnings of “50% … with 50% of that area providing information on smoking cessation”: Committee on Industry, Research, and Energy Opinion (EP) PE508.180 of 8 July 2013 Amendment 39.Google Scholar

321 See Committee on Environment, Public Health and Food Safety Report on the Proposal (EP) PE508.085 of 24 July 2013/P7_TA(2013)0398 (EP partial vote), Amendments 11 (recital 14a), 50/50–87–95 (art. 6(10a)) and 85 (annex I). See Amendments 7 (recital 10a) on Polonium 210, and 12 (recital 14b) on Regulation 1272/2008. See also COM(2005) 339 final, at 7–8; Commission Staff Working Document Impact Assessment, supra note 22, part 1 at 34, part 4 at 6, and 39–45.Google Scholar

322 See Council of the European Union General Approach, supra note 20, annex, at recital 39, and art. 23(2)(d); Directive 2014/40, supra note 6, at recital 52 subpara. 2, and art. 28(2)(d).Google Scholar

323 See Council Directive 90/239, art. 2(2), 1990 O.J. (L 137) 36 (EEC); Directive 2001/37, art. 3(1), 2001 O.J. (L 194) 26 (EC); Directive 2014/40, supra note 6, at art. 3(1).Google Scholar

324 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013; Amendment 59 (art. 18(1e)).Google Scholar

325 See Directive 2014/40, supra note 6, at art. 20(2) subpara. 1, 2(b)–(c), (e)–(g), (8)–(9); Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendment 59 (art. 18(2)).Google Scholar

326 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013 Amendments 59 (art. 18(1b)–(1c)), 73 (annex IIb); Committee on Legal Affairs Opinion (EP) PE510.591 of 25 June 2013, Amendment 74 (annex Ia).Google Scholar

327 See Committee on Internal Market and Consumer Protection Opinion (EP) PE508.048 of 20 June 2013, Amendments 49, 50 (art. 15(1a)–(1b)) and 72 (annex IIa).Google Scholar

328 Wyatt, supra note 53, at 25–26; Arnold André, Case C-434/02, supra note 4, Opinion of Advocate General Geelhoed; Swedish Match, Case C-210/03, supra note 4, Opinion of Advocate General Geelhoed at para. 78.Google Scholar

329 See Commission Staff Working Document Impact Assessment, supra note 22, part 4 at 2.Google Scholar