“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

Anatole Abaquesne de Parfourus

doi:10.1017/S2071832200023051

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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

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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

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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

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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

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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

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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

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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

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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

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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

Article contents

“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

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Article contents

“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

Abstract

References

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