Provisional text

OPINION OF ADVOCATE GENERAL

BIONDI

delivered on 11 September 2025 (1)

Joined Cases C‑448/24 and C‑449/24

British American Tobacco Belgium NV,

Nicoventures Holdings Ltd (C‑448/24)

and

DSE International BV (C‑449/24)

Belgische Staat

(Request for a preliminary ruling from the Raad van State (Council of State, Belgium))

( Reference for a preliminary ruling – Raad van State (Council of State, Belgium) – Interpretation of Article 7(6) and Article 20(3)(c) 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 – Manufacture, presentation and sale of tobacco products – Prohibition on the placing on the market of tobacco products containing certain additives – Additives that facilitate inhalation or nicotine uptake – Applicability of the prohibition to electronic cigarettes )

I. Introduction

1. The present request for a preliminary ruling raises a single question concerning the rules on electronic cigarettes and a specific category of additives under Directive 2014/40/EU. (2) In particular, the question raised by the referring court is whether, under Article 20(3) of that directive, Member States must ensure that nicotine-containing liquid in electronic cigarettes does not contain additives that facilitate inhalation or nicotine uptake as provided for in Article 7(6) of that directive.

2. That question provides an opportunity to interpret the relevant provisions in the light of scientific evidence, which has emerged in recent years, on the adverse effects of electronic cigarettes.

3. In my analysis, I will, first, make some observations on the interpretation of the two provisions before addressing the adverse effects of electronic cigarettes on human health. That will permit me to argue that, in the case of Directive 2014/40, the interpretative approach should no longer – or, rather, not only – be guided by the precautionary principle, but by the rules on the tobacco and related products sector, and, thus, by assessing the proportionality of the choices made by the EU legislature.

II. Legal framework

A. European Union law

4. Recitals 18, 39 and 41 of Directive 2014/40 state that:

‘(18) Certain additives are used to create the impression that tobacco products have health benefits, present reduced health risks or increase mental alertness and physical performance. These additives, as well as additives that have [carcinogenic, mutagenic or reprotoxic; CMR] properties in unburnt form, should be prohibited in order to ensure uniform rules throughout the Union and a high level of protection of human health. Additives that increase addictiveness and toxicity should also be prohibited.

…

(39) Only electronic cigarettes that deliver nicotine doses at consistent levels should be allowed to be placed on the market under this Directive. Delivery of nicotine doses at consistent levels under normal conditions of use is necessary for health protection, safety and quality purposes, including to avoid the risk of accidental consumption of high doses.

…

(41) In view of the fact that nicotine is a toxic substance and considering the potential health and safety risks, including to persons for whom the product is not intended, nicotine-containing liquid should only be placed on the market in electronic cigarettes or in refill containers that meet certain safety and quality requirements. …’

5. Article 1 of Directive 2014/40, headed ‘Subject matter’, reads as follows:

‘The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning:

…

(f) the placing on the market and the labelling of certain products, which are related to tobacco products, namely electronic cigarettes …;

in order to facilitate the smooth functioning of the internal market for tobacco and related products, taking as a base a high level of protection of human health, especially for young people, and to meet the obligations of the Union under the [World Health Organisation (“WHO”)] Framework Convention for Tobacco Control (“FCTC”).’

6. Article 7 of that directive, headed ‘Regulation of ingredients’, states, in paragraph 6(d), as follows:

‘Member States shall prohibit the placing on the market of tobacco products containing the following additives:

…

(d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake’.

7. Article 20 of that directive, headed ‘Electronic cigarettes’, provides, in paragraph 1, as follows:

‘The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with this Directive and with all other relevant Union legislation.’

8. Article 20(3)(c) provides that:

‘Member States shall ensure that:

…

B. Belgian law

9. Article 4(4)(5) of the koninklijk besluit van 28 oktober 2016 betreffende het fabriceren en het in de handel brengen van elektronische sigaretten (Royal Decree of 28 October 2016 on the manufacture and placing on the market of electronic cigarettes; ‘the Royal Decree of 28 October 2016’), as amended by Article 3 of the koninklijk besluit van 7 november 2022 tot wijziging van het koninklijk besluit van 28 oktober 2016 betreffende het fabriceren en het in handel brengen van elektronische sigaretten (Royal Decree of 7 November 2022 amending the Royal Decree of 28 October 2016 on the manufacture and placing on the market of electronic cigarettes; (3) ‘the Royal Decree of 7 November 2022’), headed ‘Composition and technical standards’, is worded as follows:

‘The nicotine-containing liquid shall not contain the following additives:

…

5. additives that facilitate inhalation or nicotine uptake’.

III. The main proceedings and the question referred for a preliminary ruling

10. The Royal Decree of 28 October 2016 on the manufacture and placing on the market of electronic cigarettes transposed the rules on electronic cigarettes laid down by Directive 2014/40.

11. On 6 July 2021, pursuant to Directive (EU) 2015/1535, (4) the Belgische Staat (Belgian State) notified the European Commission of a draft amendment to Article 4 of the Royal Decree of 28 October 2016, which initially provided that four groups of additives would be prohibited for electronic cigarettes.

12. However, on 7 November 2022, the Belgische Staat (Belgian State) approved a royal decree which, by amending Article 4 of the Royal Decree of 2016, includes – contrary to what was originally provided for – a fifth category of prohibited additives, namely those relating to inhalation or nicotine uptake.

13. On 13 March 2023, British American Tobacco (‘BAT’), Nicoventures Holdings Ltd (‘NH’) and DSE International BV (‘DSE’) (together, ‘the applicants in the main proceedings’) brought two actions before the Raad van State (Council of State, Belgium) seeking the annulment of the Royal Decree of 7 November 2022 on the basis of two pleas for annulment, only the second of which is relevant in the context of the preliminary ruling procedure. (5)

14. Specifically, by the second plea, the applicants claim that Article 3 of the Royal Decree of 7 November 2022 ‘exceeds the scope of the rules on electronic cigarettes and is contrary to [Directive 2014/40]’. In particular, according to the applicants, Article 7(6)(d) concerns only the category of ‘tobacco products for smoking’, a category within which electronic cigarettes do not come, since, as they do not contain tobacco, they do not give rise to combustion.

15. In support of their argument, the applicants submit that, in the light of the definitions of ‘tobacco products for smoking’ and ‘electronic cigarette[s]’ in points 9 and 16 of Article 2 of Directive 2014/40, respectively, the scope of Article 7(6)(d) of that directive is limited solely to ‘tobacco products for smoking’, to the clear exclusion of electronic cigarettes.

16. Furthermore, the applicants submit that Article 3 of the Royal Decree of 2022 constitutes a restriction contrary to Article 24 of Directive 2014/40, in so far as the latter provides that Member States may not prohibit or restrict the placing on the market of tobacco and related products as regards aspects that are harmonised by that directive.

17. Having doubts in relation to the reference that Article 20(3)(c) of Directive 2014/40 makes to Article 7(6) of that directive, the Raad van State (Council of State, Belgium), Belgium decided to stay the two main proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘Is Article 20(3)(c) of [Directive 2014/40], read in conjunction with Article 7(6) of [that directive], to be interpreted as requiring Member States to prohibit, with regard to the placing on the market of electronic cigarettes and refill containers, nicotine-containing liquid from containing additives that facilitate inhalation or nicotine uptake, as provided for in Article 7(6)(d), even if the electronic cigarette does not produce combustion or smoke?’

18. The applicants in the main proceedings, the Belgian, Czech, German, French, Austrian and Portuguese Governments, and the Commission, submitted written observations.

IV. Analysis

19. By its question referred for a preliminary ruling, the referring court asks, in essence, whether Article 20(3)(c), read in conjunction with Article 7(6), of Directive 2014/40, must be interpreted as meaning that electronic cigarettes and refill containers, the nicotine-containing liquid of which includes additives that facilitate inhalation or nicotine uptake, may not be placed on the market. The Belgian legislation specifically concerning electronic cigarettes expressly provides that nicotine-containing liquid must not contain additives that facilitate inhalation or nicotine uptake.

20. For the reasons which I will set out below, I am of the opinion that the question referred by the referring court should be answered in the affirmative.

21. It has now been twenty-five years since the landmark judgment of 5 October 2000, Germany v Parliament and Council, in which the Court held that the EU legislature may rely on the provisions relating to the establishment of the internal market, even if the protection of human health is a decisive factor in the choices to be made, provided that the measure adopted genuinely has as its object the improvement of the conditions for the establishment and functioning of the internal market. (6) The Court also clarified that harmonisation of laws and regulations of the Member States designed to protect and improve human health is excluded by the TFEU, but that does not imply that harmonising measures adopted on the basis of other provisions of the TFEU, in this case, Article 114 TFEU, cannot have any impact on the protection of human health. (7)

22. The Court has reiterated on several occasions that the harmonisation measures adopted by the European Union in the tobacco and related products sector have the ‘twofold objective’ of (a) facilitating the smooth functioning of the internal market for those products, while (b) taking as a base a high level of protection of human health, especially for young people. (8)

23. The interdependence between the two objectives can be achieved only at EU level, in order to prevent the emergence of disparities in national rules in that specific sector and thus of obstacles to free movement and distortions of competition. (9)

24. Given the primary importance of the protection of human health within the EU legal order, (10) it is furthermore for the EU legislature to take into account in its regulatory choices, first, the possible economic consequences which may arise for undertakings required to comply with the obligations and prohibitions arising from harmonisation measures and, secondly, the need to ensure a high level of health protection. The fulfilment of that requirement, as the Court has pointed out, may be ‘such as to justify even substantial negative economic consequences’. (11)

25. That being said, it is clear that the directive at issue also pursues the ‘twofold objective’ examined above, as stated in Article 1 of that directive. Article 1 of Directive 2014/40 provides for the approximation of the provisions of the Member States in order to facilitate the smooth functioning of the market for tobacco and related products and to ensure a high level of protection of human health, as well as to meet the obligations of the Union under the FCTC.

26. An analysis of the specific provisions in respect of which the referring court seeks interpretation leads to the same conclusion.

27. According to settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording, but also the context in which it occurs and the objectives pursued by the rules of which it is part. (12)

28. As regards the textual interpretation, as a preliminary point, I consider it useful to recall that Directive 2014/40 essentially concerns two types of products. On the one hand, it refers to ‘tobacco products’, under Title II of that directive, which are, in turn, divided into tobacco products ‘for smoking’ (that is to say, products involving a combustion process) and ‘smokeless’ tobacco products (including chewing tobacco, nasal tobacco and tobacco for oral use). (13) On the other hand, Directive 2014/40 concerns ‘electronic cigarettes [and] herbal products for smoking’, under Title III of that directive.

29. Article 7 comes under Chapter I of Title II, headed ‘Tobacco products’. Accordingly, the provisions in that title refer only to tobacco products. Paragraph 6(d) of Article 7 specifically refers to tobacco products for smoking, as the EU legislature intended to prohibit additives that facilitate inhalation or nicotine uptake for a specific category of tobacco products, namely, tobacco products for smoking. It follows that, in view of the textual position of Article 7 in Directive 2014/40, paragraph 6 of that provision could not have expressly referred to electronic cigarettes as well.

30. In other words, to argue, in general terms, that Article 7(6), in order to apply to electronic cigarettes, should and could have expressly referred to them, would amount to disregarding the structure of Directive 2014/40 itself.

31. Article 20, which is included in Title III, headed ‘Electronic cigarettes and herbal products for smoking’, provides in paragraph 3(c) that ‘the nicotine-containing liquid does not contain additives listed in Article 7(6)’, without making any distinction as regards tobacco products for smoking. The legislator therefore intended to refer to all additives listed in Article 7(6), including those that facilitate inhalation or nicotine uptake.

32. A textual interpretation alone could, therefore, suffice to conclude that, under Article 20(3), read in conjunction with Article 7(6), Member States must ensure that electronic cigarettes and refill containers do not contain additives that facilitate inhalation or nicotine uptake.

33. However, I am conscious that, as some of the parties have pointed out, doubts on interpretation may still linger. In my view, recourse to a teleological interpretation can dispel all such doubts. In particular, in the light of one of the objectives (14) of Directive 2014/40 – namely, to ensure a high level of protection of human health – given that scientific evidence suggests that the risk posed by electronic cigarettes is comparable, in qualitative terms, to that of traditional cigarettes.

34. As stated in recital 7 of Directive 2014/40, ‘legislative action at Union level is also necessary in order to implement the WHO Framework Convention on Tobacco Control (“FCTC”) of May 2003, the provisions of which are binding on the Union and its Member States. …’.

35. Within the scientific community, several studies have shown that electronic cigarettes have adverse effects on human health. Those effects are caused, in particular, by the type of substances produced by the use of the electronic cigarette and by the nicotine contained in the liquid of the cigarette. The adverse effects of electronic cigarettes on human health may be considered comparable to the effects of traditional cigarettes.

36. In the opinion of the Scientific Committee on Health, Environmental and Emerging Risks (‘SCHEER’) for the European Commission, adopted on 16 April 2021, it is stated that nicotine uptake through those devices may be comparable to that of traditional cigarettes. (15) For example, that committee maintains that, depending on the duration of use and the number of ‘puffs’, serum levels of nicotine from electronic cigarettes may be as high as those from a traditional cigarette. (16)

37. Technical reports published by the WHO also confirm the adverse effects of electronic cigarettes on human health. For that reason, the WHO has called on the Parties to the Convention to adopt policies to prevent and reduce nicotine addiction, which should be part of a wider tobacco control programme. (17)

38. In that specific area, where the scientific evidence is clear, the existence of a risk to public health is genuine and sufficiently demonstrated. (18)

39. It should also be noted that the precautionary principle, the parameter used by the Court in the assessment of scientific data and possible risks to health, actually involves two stages, namely: (a) the identification of the potentially negative consequences for health of the substances or foods concerned, and a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research; and (b) only where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective. (19)

40. In the case of Directive 2014/40, within the health protection perspective, it seems that it is not (or is no longer) a matter of precaution, but merely one of regulation.

41. Therefore, based on current scientific knowledge and taking into account the need to protect human health, electronic cigarettes cannot be considered risk-free for human health; the nicotine uptake they cause is not significantly different from that of traditional cigarettes.

42. Moving beyond the precautionary principle, let us now focus on assessing the proportionality of the choices made by the legislature, since that is what is at issue. Under Article 114 TFEU, the EU legislature enjoys a certain margin of discretion on how to achieve harmonisation and is authorised to intervene by adopting measures which it considers appropriate, in compliance with paragraph 3 of that article (20) and with the principles mentioned in the TFEU and in the case-law. (21)

43. The applicants in the main proceedings submit that electronic cigarettes cannot be subject to the same regime as tobacco products, given that electronic cigarettes do not give rise to combustion or produce smoke. They argue that it is precisely in those terms that the harmonisation must be interpreted, that is to say that, in view of the different objective characteristics of the two products, electronic cigarettes must be regulated separately from tobacco products. That argument is unpersuasive: it is indeed the case that, in previous judgments, the Court has expressly recognised that ‘[electronic cigarettes] can be distinguished from [tobacco products] by their objective characteristics and by their novelty on the market concerned, which justifies the application to them of specific rules’. (22)

44. However, the fact that electronic cigarettes may be the subject of specific regulation does not, at the same time, justify that such regulation may escape the fundamental objective of protection of human health which Directive 2014/40 seeks to achieve. (23)

45. For the same reason, to hold that the harmonisation should be pursued by maintaining a different regulatory regime for the two types of products concerned – electronic cigarettes and tobacco products – would, in my view, amount to considering only one of the objectives, namely, that of ensuring the proper functioning of the internal market, while disregarding the other objective, namely, that of the high level of protection of human health. That objective, however, as set out in paragraph 24, serves as a guiding principle in the interpretation of provisions such as those at issue here.

46. In that regard, I am concerned that, if the prohibition on additives that facilitate inhalation or nicotine uptake were considered inapplicable to electronic cigarettes, the risk of harmful adverse effects on the health of consumers, and, in particular, of young people, who represent the largest group of consumers of that type of product, would increase. (24)

47. Moreover, if the EU legislature had expressly provided that the prohibition on additives at issue did not apply to electronic cigarettes, that would have had the consequence that, in stark contrast to the rationale underlying recital 43 of Directive 2014/40, electronic cigarettes would have become a gateway to nicotine addiction. (25)

48. It would therefore constitute a risk that the EU legislature could not have covered, taking into account the precautionary principle (formerly) and the proportionality principle (presently), especially in the light of current scientific knowledge. Under the precautionary principle, inter alia, the EU legislature is already fully authorised to take protective measures without having to wait until the reality and seriousness of the risks become apparent, where there is uncertainty as to the existence or extent of the risks to human health. (26)

49. That is clearly confirmed by recital 41 of Directive 2014/40, which, in stating that nicotine ‘is a toxic substance’ that presents ‘potential health … risks, including to persons for whom the product is not intended’, states that nicotine-containing liquid – that is to say, the liquid used by electronic cigarettes – ‘should only be placed on the market in electronic cigarettes or in refill containers that meet certain safety and quality requirements’.

50. Furthermore, to hold that the prohibition at issue does not also apply to electronic cigarettes would amount to ignoring the warning of the WHO in that regard. Indeed, at the sixth session of the Conference of the Parties to the Framework Convention held on 18 October 2014, it was recommended that the parties also prohibit or regulate the use of electronic cigarettes, ‘taking into account a high level of protection for human health’. (27) In addition, recently, in the technical note of 2023, after noting that, according to scientific studies, electronic cigarettes are not effective for smoking cessation, the WHO called on the parties to take action to reduce the risks arising from the use of electronic cigarettes, paying particular attention to young people. (28)

51. It may therefore be concluded that, in the light of the precautionary principle and the principle of proportionality, it cannot be held that, contrary to the assertion of the applicants in the proceedings, a restriction, such as that introduced by the Belgische Staat (Belgian State), is additional, compared to what is already provided for in Directive 2014/40, with the consequence that it is not contrary to Article 24(1) of Directive 2014/40, headed ‘Free movement’.

52. I am therefore of the opinion that Article 3 of the Royal Decree of 7 November 2022 of the Belgische Staat (Belgian State), in providing that nicotine-containing liquid must not contain additives that facilitate inhalation or nicotine uptake, is not contrary to Directive 2014/40 as a whole.

53. It follows that applying the prohibition on additives that facilitate inhalation or nicotine uptake also to electronic cigarettes is, in my view, to be regarded as a measure aimed at achieving the objective of ensuring a high level of protection of human health, in accordance with the relevant provisions of the TFEU and the Charter. (29)

V. Conclusion

54. In the light of the foregoing considerations, I propose that the Court of Justice answer the request for a preliminary ruling from the Raad van State (Council of State, Belgium), Belgium as follows:

Article 20(3)(c), read in conjunction with Article 7(6), 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, must be interpreted as meaning that Member States must ensure that nicotine-containing liquid does not contain additives that facilitate inhalation or nicotine uptake, as provided for in Article 7(6)(d), even in the case of electronic cigarettes that do not give rise to combustion or produce smoke.

1 Original language: Italian.

2 Directive 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).

3 Belgisch Staatsblad, 11 January 2023, p. 5873.

4 Directive of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (codification) (OJ 2015 L 241, p. 1). In accordance with that directive, under the principle of sincere cooperation, Member States are required to notify the Commission of their legislative proposals in the field of technical regulations prior to their adoption.

5 The referring court, having considered that the first plea can be decided in the alternative to the second, suspended the examination of the first plea without making any request for a preliminary ruling in that regard. For the sake of completeness, by the first plea raised in the main proceedings, the parties claim that Belgium did not correctly communicate the draft royal decree to the European Commission, with the result that there was an infringement of the procedural requirements of Directive 2015/1535.

6 Judgment of 5 October 2000, Germany v Parliament and Council (C‑376/98, EU:C:2000:544, paragraph 88).

7 Judgment of 5 October 2000, Germany v Parliament and Council (C‑376/98, EU:C:2000:544, paragraphs 77 and 78). See, lastly, judgment of 26 June 2025, PJ Carroll and Nicoventures Trading (C‑759/23, EU:C:2025:477, paragraph 40 and the case-law cited).

8 See, to that effect, judgments of 10 December 2002, British American Tobacco (Investments) and Imperial Tobacco (C‑491/01, EU:C:2002:741, paragraph 124), and of 4 May 2016, Poland v Parliament and Council (C‑358/14, EU:C:2016:323, paragraph 80).

9 See, to that effect, judgments of 10 December 2002, British American Tobacco (Investments) and Imperial Tobacco (C‑491/01, EU:C:2002:741, paragraphs 64 and 179), and of 4 May 2016, Poland v Parliament and Council (C‑358/14, EU:C:2016:323, paragraphs 117 and 118).

10 In accordance with the second sentence of Article 35 of the Charter of Fundamental Rights, and Article 9 TFEU, Article 114(3) TFEU and Article 168(1) TFEU, a high level of human health protection must be ensured in the definition and implementation of all the European Union’s policies and activities – including, therefore, in the implementation of harmonisation (see, most recently, judgment of 22 June 2023, Commission v Hungary (Declaration of intent prior to an asylum application), C‑823/21, EU:C:2023:504, paragraph 55).

11 See, inter alia, judgment of 22 November 2018, Swedish Match (C‑151/17, EU:C:2018:938, paragraph 54).

12 See, most recently, judgment of 9 January 2025, Holding Communal (C‑627/23, EU:C:2025:9, paragraph 28 and the case-law cited).

13 See, in that regard, Article 2(4), (5), (9) and (13), and Article 19(4) of Directive 2014/40.

14 See judgment of 4 May 2016, Poland v Parliament and Council (C‑358/14, EU:C:2016:323, paragraph 80), in which the Court expressly affirmed ‘the twofold objective [of Directive 2014/40] of facilitating the smooth functioning of the internal market for tobacco and related products, while taking as a base a high level of protection of human health, especially for young people’. See also judgments of 4 May 2016, Philip Morris Brands and Others (C‑547/14, EU:C:2016:325, paragraph 220); of 22 February 2022, Stichting Rookpreventie Jeugd and Others (C‑160/20, EU:C:2022:101, paragraph 32); and of 15 May 2025, Bundesminister für Gesundheit (C‑717/23, EU:C:2025:351, paragraph 49). See, lastly, judgment of 26 June 2025, PJ Carroll and Nicoventures Trading (C‑759/23, EU:C:2025:477, paragraphs 54 and 55).

15 Scientific Committee on Health, Environmental and Emerging Risks, European Commission, Opinion on electronic cigarettes, 16 April 2021, p. 6.

16 Ibid, p. 8. Furthermore, in the light of the scientific evidence on the adverse effects of so-called ‘emerging’ products such as electronic cigarettes (see point 2 of Council Recommendation on smoke- and aerosol-free environments replacing Council Recommendation 2009/C 296/02 (legal basis proposed by the Commission: Article 168(6) TFEU – Note ST/15059/2024/INIT) of the General Secretariat of the Council of the European Union (14 November 2024)), the Council of the European Union adopted a recommendation headed ‘Council Recommendation of 3 December 2024 on smoke- and aerosol-free environments replacing Council Recommendation 2009/C 296/02’ (OJ C C/2024/7425). Unlike the previous – now repealed – recommendation, the scope of that recommendation, which was adopted on 3 December 2024, was extended to include also electronic cigarettes.

17 WHO, Technical Note on Call to action on electronic cigarettes, December 2023, p. 5. Among other things, in the judgment of 4 May 2016, Pillbox 38 (C‑477/14, EU:C:2016:324, paragraph 51), the Court, in examining the validity of Article 20 of Directive 2014/40, also took into consideration a WHO report of 1 September 2014 headed ‘Electronic nicotine delivery systems: Report by WHO’ (FCTC/COP/6/10 Rev.1, available here: https://iris.who.int/handle/10665/147110). See, by analogy, judgment of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 79).

18 See, by analogy, judgments of 2 December 2004, Commission v Netherlands (C‑41/02, EU:C:2004:762, paragraph 49); of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 109); and of 28 January 2010, Commission v France (C‑333/08, EU:C:2010:44, paragraph 87).

19 See, by analogy, judgment of 19 January 2017, Queisser Pharma (C‑282/15, EU:C:2017:26, paragraphs 56 and 57).

20 Paragraph 3 of Article 114 TFEU provides as follows: ‘The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.’ See also, lastly, judgment of 26 June 2025, PJ Carroll and Nicoventures Trading (C‑759/23, EU:C:2025:477, paragraph 41 and the case-law cited).

21 See, to that effect, judgments of 4 May 2016, Philip Morris Brands and Others (C‑547/14, EU:C:2016:325, paragraphs 62 and 63), and of 22 June 2017, E.ON Biofor Sverige (C‑549/15, EU:C:2017:490, paragraph 49).

22 See judgment of 4 May 2016, Pillbox 38 (C‑477/14, EU:C:2016:324, paragraph 62). In paragraph 63, the Court further considered the comparison between the rules applicable to tobacco products and those relating to electronic cigarettes and refill containers to be irrelevant, in view of the differences between the two categories of products.

23 In that regard, I agree with the Commission’s observations on that point. The Commission submits that it is incompatible with the objective of ensuring a high level of protection of human health to consider that, since electronic cigarettes emit vapour, additives that facilitate inhalation or nicotine uptake may be excluded from the additives prohibited and listed in Directive 2014/40, in accordance with Article 20(3)(c), read in conjunction with Article 7(6).

24 According to the opinion of SCHEER for the European Commission, cited in footnote 16 above, the number of young people using electronic cigarettes has increased significantly in the European Union from 7.2% in 2012 to 14.6% in 2017 (p. 17). Furthermore, according to a recent study conducted jointly by the Organisation for Economic Co-operation and Development (OECD) and the European Commission, headed ‘Health at a Glance: Europe 2024 – State of Health in the EU Cycle’ (OECD Publishing, 2024, Paris), the use of electronic cigarettes in European countries ‘[is] significantly higher among young people’ (p. 118).

25 In recital 43 of Directive 2014/40, the EU legislature states 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.’

26 See, to that effect, judgment of 10 April 2014, Acino v Commission (C‑269/13 P, EU:C:2014:255, paragraph 57 and the case-law cited).

27 See ‘DECISION: Electronic nicotine delivery systems and electronic non-nicotine delivery systems’ from the Conference of the Parties to the WHO Framework Convention on Tobacco Control, adopted at its sixth session in Moscow on 18 October 2014, FCTC/COP/6(9) (point 3 of the decision), which is available here: https://iris.who.int/handle/10665/145116.

28 See WHO, Technical Note on Call to action on electronic cigarettes, December 2023, in particular page 3, which states that ‘young people in many countries are increasingly taking up the use of e-cigarettes and this trend has been reported to be of great public health concern by several countries’.

29 Cited in footnote 10 above.