Fernlund and S. Rodin (Rapporteur), Judges, Advocate General: H. Saugmandsgaard Øe, Swedish Match AB v Secretary of State for Health. Swedish Match AB v Secretary of State for Health Policy area: Employment and social policy Deciding Body type: Court of Justice of the European Union Deciding Body: Advocate General Type: Opinion Decision date: 12/04/2018 Tátrai, acting as Agents. (45) In essence, Swedish Match and the NNA focus on the data and arguments which advocate the effectiveness of tobacco for oral use as a cessation aid and the absence of any gateway effect. The Commission proposal and the impact assessment served as a basis for the adoption of Directive 2014/40, recital 32 of which is worded as follows: ‘Council Directive 89/622/EEC [(11)] prohibited the sale in the Member States of certain types of tobacco for oral use. 10      Opinion adopted on 6 February 2008 entitled ‘Health Effects of Smokeless Tobacco Products’. These different approaches reflect two distinct strands of tobacco control. The prohibition of the sale of tobacco for oral use should be maintained in order to prevent the introduction in the Union (apart from Sweden) of a product that is addictive and has adverse health effects. ocr . In those circumstances, the suitability of Article 1(c) and Article 17 of Directive 2014/40 to protect human health must be examined in the light of the precautionary principle, as enshrined in Article 191(2) TFEU and clarified in the case-law. Gotlands Snus AB, a Swedish smokeless tobacco company. –        New Nicotine Alliance, by P. Diamond, Barrister. 69      See judgments of 14 December 2004, Swedish Match (C‑210/03, EU:C:2004:802, paragraph 66), and of 14 December 2004, Arnold André (C‑434/02, EU:C:2004:800, paragraph 64). As I pointed out above, in the absence of certainty as to the nature and the extent of the health risks of certain products, determining the level of risk deemed unacceptable for the population is part of a political, economic and social choice which is within the discretion of the legislature, guided by the precautionary principle. 1        This request for a preliminary ruling concerns the validity of Article 1(c) and Article 17 of Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 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 (OJ 2014 L 127, p. 1). 77      It is apparent from the order for reference that Swedish Match claims that Directive 2014/40 provides no specific and consistent explanation of the selective prohibition of tobacco products for oral use and adds that nor is such an explanation apparent from the context of that directive. The legislature considered, as it had already in 1992 and in 2001, that, in order to also achieve the abovementioned health protection objective, such harmonisation had to be carried out by prohibiting that product. 7      Judgment of 14 December 2004 (C‑434/02, EU:C:2004:800). Judgment of the Court. (62) Moreover, that requirement corresponds with the requirement that the criteria on which the EU legislature relies must be objective. 15      The prohibition on placing tobacco products for oral use on the market also constitutes, according to Swedish Match, an unjustified restriction on the free movement of goods, since it is contrary to the principles of non-discrimination and proportionality and in breach of the obligation to state reasons. However, recital 34 of that directive acknowledges that all tobacco products are harmful and the Court has demonstrated the potential health risks of electronic cigarettes in the judgment in Pillbox 38. In the United Kingdom, Article 1(c) and Article 17 of Directive 2014/40 have been implemented by Regulation 17 of the Tobacco and Related Products Regulations 2016 (‘the Tobacco Regulations’), which provides that ‘no person may produce or supply tobacco for oral use’. (32) That is the case since ‘the [EU] judicature cannot substitute its assessment of the scientific and technical facts for that of the legislature on which the Treaty has placed that task’. See recital 2 of Directive 2014/40. 86. (14) A number of Member States had therefore prohibited the placing on the market of tobacco for oral use or were in the process of doing so, with the result that a harmonisation of national laws was considered necessary to prevent obstacles to trade which were likely to result from a heterogeneous development of those laws. Swedish Match develops, manufactures, and sells quality products with market leading brands in the product segments Smokefree, Cigars, and Lights. In her Opinion in Philip Morris Brands and Others (C‑547/14, EU:C:2015:853, point 179), Advocate General Kokott stated that the protection of human health has ‘considerably greater’ importance in the value system under EU law than the economic interests of operators. The argument alleging the existence of changes in the legislative context. (65) As can be seen from recital 32 of Directive 2014/40, the EU legislature did not, therefore, deem it necessary to prohibit the placing on the market of those products. 47. See, also, Opinion of Advocate General Geelhoed in British American Tobacco (Investments) and Imperial Tobacco (C‑491/01, EU:C:2002:476, points 226 and 229). In his first major speech as Secretary of State, Antony Blinken set the foreign policy priorities for the new Biden administration, touching on such topics as climate change, the COVID-19 crisis, democracy, and the challenge posed by China. (40) The discretion enjoyed by the legislature to evaluate the risks extends, in my view, to the evaluation of the reliability and the relevance of the available studies, the interpretation of the results of those studies and the determination of the relative weight to be assigned to each relevant study. Further, according to Swedish Match, the prohibition of tobacco products for oral use cannot be justified on public health grounds since the current scientific data, not available at the time of adoption of Council Directive 92/41/EEC of 15 May 1992 amending Directive 89/622 (OJ 1992 L 158, p. 30), demonstrates that those products are at the lower end of the risk scale in terms of adverse health effects as compared with other smokeless tobacco products. A large number of passive smokers would be spared as a result. Household Essentials. Swedish Match AB v Secretary of State for Health. 38. In my view, that choice is not manifestly inappropriate in pursuit of the twofold objective of that directive. The Court held that those products, although they are not fundamentally different in their composition or indeed their intended use from tobacco products intended to be chewed, were not in the same situation as the latter products by reason of the fact that the tobacco products for oral use which were the subject of the prohibition laid down in Article 8a of Directive 89/622 and repeated in Article 8 of Directive 2001/37 were new to the markets of the Member States subject to that measure (judgments of 14 December 2004, Swedish Match, C‑210/03, EU:C:2004:802, paragraph 71, and of 14 December 2004, Arnold André, C‑434/02, EU:C:2004:800, paragraph 69). The validity of Article 1(c) and Article 17 of Directive 2014/40 having regard to the principle of equal treatment. Case C-151/17, Swedish Match AB v Secretary of State for Health, ECLI:EU: C:2018:938 The prohibition on the placing on the market of tobacco for oral use is not in breach of the EU general principles of non-discrimination, proportionality and subsidiarity, of Articles 296, 34 and 35 TFEU and of Articles 1, 7 and 35 of the Charter. (41) It is sufficient to state that, in any event, on the one hand, it has not been established that the conclusions that Swedish Match and the NNA draw from those studies would achieve a consensus within the scientific community and that the uncertainties taken into account by the legislature would therefore be resolved. 62      In the judgment of 5 July 2017, Fries (C‑190/16, EU:C:2017:513, paragraph 48), the Court applied to an EU measure the settled case-law concerning the appropriateness of a national measure which restricts the freedoms of movement guaranteed by the TFEU to attain its objective in a consistent and systematic way (see, inter alia, judgment of 23 December 2015, Scotch Whisky Association and Others (C‑333/14, EU:C:2015:845, paragraph 37 and the case-law cited)). 73      In having prohibited the placing on the market of tobacco products for oral use, while permitting the marketing of other tobacco products, the EU legislature must be regarded as having undertaken a harmonisation in stages of tobacco products. svenska. (75) According to the Court, all the other measures aimed at making manufacturers subject to technical standards to reduce the harmfulness of the product or at regulating the labelling on the packaging of that product and the conditions of sale, in particular to minors, would not have the same effect in terms of health protection, inasmuch as they would let a product which is in any event harmful gain a place in the market. Further, as stated in paragraph 26 of the present judgment, such products would, if placed on the market, represent novel products for consumers. Bankia SA v Juan Carlos Mari Merino e.a. 2018 . 64 to 69. 29 . Boarder member since 2018. 49      Given that, if the prohibition on placing on the market tobacco products for oral use were to be lifted, the positive effects would be uncertain with respect to the health of consumers seeking to use those products as an aid to the cessation of smoking and, moreover, there would be risks to the health of other consumers, particularly young people, requiring the adoption, in accordance with the precautionary principle, of restrictive measures, Article 1(c) and Article 17 of Directive 2014/40 cannot be regarded as being manifestly inappropriate to the objective of ensuring a high level of public health. It falls to the legislature to examine whether the objectives pursued are such as to justify even substantial negative economic consequences for certain operators. –        the Hungarian Government, by M.Z. The claim by Swedish Match and the NNA that tobacco for oral use is also a ‘novel’ product in accordance with recital 34 of Directive 2014/40 and the case-law of the Court is unsuccessful. In the context of its action, Swedish Match claims that the total prohibition on the placing on the market of tobacco for oral use in the United Kingdom, imposed by Regulation 17 of the Tobacco Regulations, is not compatible with EU law. –        the Norwegian Government, by M. Reinertsen Norum, acting as Agent, and by K. Moen, advocate. Moreover, where Swedish Match and the NNA invoke a number of studies postdating the adoption of Directive 2014/40 which, they contend, rule out any association between the consumption of tobacco for oral use and the increased risks of oral and pancreatic cancers, I do not think that there is any need to establish whether and, if so, to what extent, those studies must be taken into consideration when examining the validity of the provisions at issue. Those provisions therefore maintain an obligation which has been binding upon the Member States since 1992 (3) and had already been renewed in Article 8 of Directive 2001/37/EC, (4) the instrument which preceded Directive 2014/40. –        the European Parliament, by A. Tamás and I. McDowell, acting as Agents. Luxembourg, 12 April 2018 Advocate General’s Opinion in Case C-151/17 Swedish Match AB v Secretary of State for Health Advocate General Saugmandsgaard Øe proposes that the Court hold that the prohibition on the placing on the market of snus is valid A snus manufacturer challenged on several bases the validity of a provision in Directive 2001/37/EC that directs member states to prohibit the marketing of any tobacco products designed for oral use, except those tobacco products designed to be smoked or chewed. 86      It is apparent from the order for reference that Swedish Match and the NNA claim that Article 1(c) and Article 17 of Directive 2014/40 are in breach of Articles 1, 7 and 35 of the Charter, since the effect of the prohibition on the placing on the market of tobacco products for oral use is that individuals who want to stop smoking cannot use products that would improve their health. In the second place, those acts cannot exceed the limits of what is necessary for that purpose: when there is a choice between several appropriate measures, the least onerous must be favoured (‘necessity test’). 87      In that regard, Article 52(1) of the Charter provides that any limitation on the exercise of the rights and freedoms recognised by the Charter must be provided for by law and must respect the essence of those rights and freedoms. Following that analysis, I consider that the provisions at issue are not manifestly inappropriate to pursue their twofold objective, do not go manifestly beyond what is necessary in order to attain the objective and do not lead to disadvantages which are manifestly disproportionate to the advantages sought. Financial tables More Less. 74      Article 24(3) of Directive 2014/40 therefore concerns an aspect which is not covered by the harmonisation measures in that directive (judgment of 4 May 2016, Philip Morris Brands and Others, C‑547/14, EU:C:2016:325, paragraph 90). 66      Since the present case concerns an area — the improvement of the functioning of the internal market — which is not among those in respect of which the European Union has exclusive competence, it must be determined whether the objective of Directive 2014/40 could be better achieved at EU level (judgment of 4 May 2016, Philip Morris Brands and Others, C‑547/14, EU:C:2016:325, paragraph 219). 48. 25. Clergeau and Others. They submit that Directive 2014/40 does not prohibit the placing on the market of any other tobacco product (60) and that, in particular, tobacco for smoking and chewing tobacco or nasal tobacco are more harmful than tobacco for oral use. Fernlund and S. Rodin (Rapporteur), Judges. Bastei Lübbe GmbH & Co. KG v Michael Strotzer. Only by observing those reactions on the market could it be ascertained whether a possible substitution effect would prevail over the possible effects of initiation, a gateway and dual use, or vice versa, given that all of those effects may occur simultaneously. and Swedish Match UK Ltd (hereinafter referred to together as 'Swedish Match') and the Secretary of State for Health concerning the prohibition of the marketing in the United Kingdom of tobacco products for oral use. 45      Consequently, having thus taken into account all the scientific studies referred to in the impact assessment, the Commission considered that the precautionary principle justified maintaining the prohibition on placing tobacco products for oral use on the market. That category covers all of the products which do not fall under the other categories laid down in that directive and which might be introduced to the EU market after its entry into force. 55      With respect to the objective of facilitating the smooth functioning of the internal market of tobacco and related products, it must be stated that the prohibition on the placing on the market of tobacco products for oral use laid down by those provisions is also appropriate to facilitating the smooth functioning of the internal market of tobacco and related products. (15). 66      Impact assessment, pp. Richard Austen Butler, Baron Butler of Saffron Walden, KG, CH, PC, DL (9 December 1902 – 8 March 1982), also known as R. A. Butler and familiarly known from his initials as Rab, was a prominent British Conservative politician. 74      Judgment of 14 December 2004 (C‑210/03, EU:C:2004:802, paragraph 57). The discretion it has for the purposes of determining the level of the risk deemed unacceptable for the population extends, if necessary, to a weighing up of the prevention of a number of health risks where those risks cannot be avoided simultaneously. 41      With respect to the objective of ensuring a high level of protection of human health, especially for young people, it is apparent from the impact assessment (p. 62 et seq.) Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. 9        Swedish Match is a public limited liability company established in Sweden which primarily markets smokeless tobacco products and, in particular, ‘snus’. 36. In that regard, the Court added that Directive 2014/40 is aimed at ensuring such a level of health protection for the population as a whole, and therefore its ability to guarantee that aim cannot be assessed solely in relation to a single category of consumers. Snus forms part, together with other tobacco harm reduction products, already available in the United Kingdom, of a coherent tobacco harm reduction strategy. By its request for a preliminary ruling, the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) (United Kingdom) asks the Court to rule on the validity of Article 1(c) and Article 17 of Directive 2014/40/EU. 71. According to those parties, lifting that prohibition would allow tobacco products for smoking to be replaced by other less harmful tobacco products (substitution effect). 1. 6      Judgment of 14 December 2004 (C‑210/03, EU:C:2004:802). Opinion delivered on 12 April 2018 Advocate General Henrik Saugmandsgaard Øe. As requested by the Court, this Opinion will, however, be limited to the analysis of that question in so far as it seeks to ascertain whether those provisions are contrary to the principle of proportionality. 75. In the light of its assessment of the risks to public health which might result from lifting the prohibition at issue, the legislature decided to maintain that prohibition in Directive 2014/40. 84      Judgment of 14 December 2004 (C-434/02, EU:C:2004:800). Such national provisions shall be notified to the Commission together with the grounds for introducing them. 29      As regards the alleged breach of the principle of equal treatment because of the less favourable treatment of tobacco products for oral use as compared with electronic cigarettes, the Court has previously held that the objective characteristics of the latter differ from those of tobacco products in general and, therefore, that electronic cigarettes are not in the same situation as tobacco products (see, to that effect, judgment of 4 May 2016, Pillbox 38, C‑477/14, EU:C:2016:324, paragraphs 36 and 42). 56      The Court observed in paragraph 37 of its judgment of 14 December 2004, Swedish Match (C‑210/03, EU:C:2004:802), that there were differences, at the time of adoption of Directive 92/41, between the laws, regulations and administrative provisions of the Member States intended to stop the expansion in consumption of products harmful to health which were novel to the markets of the Member States and were thought to be especially attractive to young people. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because the results of studies conducted are inconclusive, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (judgment of 9 June 2016, Pesce and Others, C‑78/16 and C‑79/16, EU:C:2016:428, paragraph 47 and the case-law cited). Income statement; Balance sheet; ... Case C-210/03: R v. Secretary of State for Health ex parte 1) Swedish Match AB 2) Swedish Match UK Ltd Case C-434/02: Arnold André GmbH & Co. KG v. Landrat of the Herford Local Authority breach of the EU general principle of proportionality; iii. It is sufficient to state that the arguments put forward by Swedish Match and the NNA demonstrate, at most, that scientific uncertainties remain with regard to the nature and extent of the effects that lifting the prohibition on the placing on the market of tobacco for oral use throughout the European Union would have on consumer behaviour. That discretion was not called into question by the argument, raised by the NNA at the hearing, that the prohibition on the placing on the market of tobacco for oral use restricts the right to health enshrined in Article 35 of the Charter. 16 Poland v European Parliament and Council, supra note 6, para. 57      Just as the Court stated in that same judgment that the legislative context had not changed at the time of adoption of Directive 2001/37, which had also prohibited the placing on the market of tobacco products for oral use (see, to that effect, judgment of 14 December 2004, Swedish Match, C‑210/03, EU:C:2004:802, paragraph 40), it must be observed that that context remained the same at the time of adoption of Directive 2014/40. (33), 41. 76      It follows that Article 1(c) and Article 17 of Directive 2014/40 are not in breach of the principle of subsidiarity. 36 – 55; Case C-151/17, Swedish Match AB v. Secretary of State for Health, 2018 E.C.R. 22      According to settled case-law, the principle of equal treatment requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (judgment of 7 March 2017, RPO, C‑390/15, EU:C:2017:174, paragraph 41). 3. The Commission acknowledged in the impact assessment that, although certain harmful effects linked to the consumption of tobacco for oral use were considered to be established, the existence and the extent of other harmful effects remained uncertain. Again, the fact that tobacco products for oral use are produced for the mass market cannot justify the discrimination to which they are subject, since other products falling within the scope of that directive, in particular other smokeless tobacco products, electronic cigarettes and novel tobacco products, are also produced for the mass market. 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