Staatssecretaris Jeugd, Preventie en Sport v Diamond Flavours BV and UEG Holland BV (C-665/24)

Contents

Judgment of the Court (Seventh Chamber)11 December 2025^note(Reference for a preliminary ruling — Directive 2014/40/EU — Article 2(40) — Concept of placing on the market — Article 23(2) and (3) — Checks on the implementation of Directive 2014/40 — Objective of ensuring a high level of health protection — Approximation of laws — Manufacture, presentation and sale of tobacco products — Supply of refill containers for electronic cigarettes displaying an incorrect indication of the nicotine content on their packaging by a distributor of tobacco and related products to a retail outlet — Fine imposed on the distributor — Principle nulla poena sine culpa — Proportionality of the fine)In Case C‑665/24,REQUEST for a preliminary ruling under Article 267 TFEU from the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry, Netherlands), made by decision of 8 October 2024, received at the Court on 11 October 2024, in the proceedingsStaatssecretaris Jeugd, Preventie en SportvDiamond Flavours BV,UEG Holland BV,THE COURT (Seventh Chamber),composed of K. Jürimäe (Rapporteur), President of the Second Chamber, acting as President of the Seventh Chamber, M. Gavalec and Z. Csehi, Judges,Advocate General: M. Szpunar,Registrar: A. Calot Escobar,having regard to the written procedure,after considering the observations submitted on behalf of:– UEG Holland BV and Diamond Flavours BV, by J.A. Jacobs, advocaat,– the Netherlands Government, by M.K. Bulterman and P.P. Huurnink, acting as Agents,– the European Commission, by E.E. Schmidt and F. van Schaik, acting as Agents,having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,gives the following

Judgment

1This request for a preliminary ruling concerns the interpretation of Article 23(2) 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), read in conjunction with Article 2(40) and Article 20(2) and (4)(b)(i) of Directive 2014/40.

2The request has been made in proceedings between Diamond Flavours BV and UEG Holland BV, two distributors, inter alia, of refill containers for electronic cigarettes, and the Staatssecretaris Jeugd, Preventie en Sport (Minister for Youth, Prevention and Sport, Netherlands) (‘the Minister’) concerning a fine imposed by the Minister on Diamond Flavours and UEG Holland for having placed on the market refill containers for electronic cigarettes the unit packets of which indicated inaccurate nicotine content.

Legal context

European Union law

Directive 2014/40

3Recitals 8, 13 and 59 of Directive 2014/40 read as follows:(8) In accordance with Article 114(3) [TFEU], a high level of health protection should be taken as a base for legislative proposals and, in particular, any new developments based on scientific facts should be taken into account. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco on human health, health protection should be given high importance, in particular, to reduce smoking prevalence among young people.…(13) In order to carry out their regulatory tasks, Member States and the Commission require comprehensive information on the ingredients and emissions from tobacco products to assess the attractiveness, addictiveness and toxicity of tobacco products and the health risks associated with the consumption of such products. To this end, the existing reporting obligations for ingredients and emissions should be strengthened. Additional enhanced reporting obligations should be provided for in respect of additives included in a priority list in order to assess, inter alia their toxicity, addictiveness and carcinogenic, mutagenic or reprotoxic properties …, including in combusted form. The burden of such enhanced reporting obligations for SMEs should be limited to the extent possible. Such reporting obligations are consistent with the obligation placed on the Union to ensure a high level of protection for human health.…(59) The obligation to respect the fundamental rights and legal principles enshrined in the Charter of Fundamental Rights of the European Union is not changed by this Directive. Several fundamental rights are affected by this Directive. It is therefore necessary to ensure that the obligations imposed on manufacturers, importers and distributors of tobacco and related products not only guarantee a high level of health and consumer protection, but also protect all other fundamental rights and are proportionate with respect to the smooth functioning of the internal market. The application of this Directive should respect Union law and relevant international obligations.’

4Article 1 of that directive, entitled ‘Subject matter’, is worded 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 and refill containers, and herbal products for smoking;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 Organization (WHO)] Framework Convention for Tobacco Control (“FCTC”).’

5Article 2 of that directive, entitled ‘Definitions’, provides:‘…(16) “electronic cigarette” means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges;(17) “refill container” means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette;…(30) “unit packet” means the smallest individual packaging of a tobacco or related product that is placed on the market;…(37) “manufacturer” means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark;…(39) “importer of tobacco or related products” means the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the territory of the Union;(40) “placing on the market” means to make products, irrespective of their place of manufacture, available to consumers located in the Union, with or without payment, including by means of distance sale; in the case of cross-border distance sales the product is deemed to be placed on the market in the Member State where the consumer is located;(41) “retail outlet” means any outlet where tobacco products are placed on the market including by a natural person.’

6Article 20 of that directive, entitled ‘Electronic cigarettes’, provides:1. 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.This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67),] or to the requirements set out in Directive 93/42/EEC [Council of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1)].2. Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. … A new notification shall be submitted for each substantial modification of the product.The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:…(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;…4.Member States shall ensure that:…(b) unit packets and any outside packaging of electronic cigarettes and refill containers:(i) include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;…’

7Article 23 of Directive 2014/40, entitled ‘Cooperation and enforcement’, provides, in paragraphs 2 and 3:2. Member States shall ensure that tobacco and related products which do not comply with this Directive, including the implementing and delegated acts provided for therein, are not placed on the market. Member States shall ensure that tobacco and related products are not placed on the market if the reporting obligations set out in this Directive are not complied with.3. Member States shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures that are necessary to ensure that these penalties are enforced. The penalties provided for shall be effective, proportionate, and dissuasive. Any financial administrative penalty that may be imposed as a result of an intentional infringement may be such as to offset the economic advantage sought through the infringement.’

Regulation (EU) 2019/1020

8Article 2 of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ 2019 L 169, p. 1), entitled ‘Scope’, provides, in paragraph 1:‘This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (“Union harmonisation legislation”), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement.’

9Annex I to Regulation 2019/1020, entitled ‘List of Union harmonisation legislation’, lists the EU acts which fall within the EU harmonisation legislation referred to in Article 2 of that regulation. Those acts include, in point 55 of that annex, Directive 2014/40.

Netherlands law

10Directive 2014/40 was transposed into Netherlands law by the Tabaks – en rookwarenwet (Law on tobacco products and smoking products) of 10 March 1988 (Stb. 1988, No 342; ‘the Law on tobacco products’), the Tabaks – en rookwarenbesluit (Decree on tobacco products and smoking products) of 14 October 2015 (Stb. 2015, No 398) and the Tabaks – en rookwarenregeling (Ministerial regulation on tobacco products and smoking products) of 10 May 2016 (Stcrt. 2016, No 25446).

11It is apparent from Article 1(1) of the Law on tobacco products that the ‘placing on the market’ is the act of making products available to consumers. The concept of ‘importer of tobacco and related products’ is defined, in Netherlands law, as the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the Netherlands.

12Under Article 3(1) of the Law on tobacco products, read in conjunction with Article 2(2)(a) of that law, Article 3.3 of the Decree on tobacco products and smoking products and Article 3.10(1) of the Ministerial regulation on tobacco products and smoking products, it is prohibited to place on the market unit packets which do not indicate the nicotine content of refill containers. In the event of a breach of that prohibition, the Minister may impose an administrative fine, in accordance with Article 11b(1) of that law.

The dispute in the main proceedings and the questions referred for a preliminary ruling

13An inspector from the Nederlandse Voedsel – en Warenautoriteit (Netherlands Food and Consumer Product Safety Authority, Netherlands) took samples from five refill containers for electronic cigarettes which he had purchased on the websites of various retail outlets. Following that sampling, that inspector found that the nicotine content of those refill containers was lower than that indicated on the unit packet of those containers.

14The retail outlets had obtained the refill containers subject to the checks from two different distributors. Those distributors had purchased those refill containers, before bringing them into the Netherlands, from a manufacturer established in France, an importer established in Ireland and an importer established in Hungary.

15By decisions of 18 and 25 October 2019, the Minister imposed on those distributors five administrative fines, amounting, for each of them, to EUR 450, for having placed on the market refill containers for electronic cigarettes, the unit packets of which refer to an incorrect nicotine content.

16Those distributors brought an action before the rechtbank Rotterdam (District Court, Rotterdam, Netherlands) against those fines. By judgment of 7 April 2021, that court declared that their actions were well founded and annulled those fines on the ground that the distributors in question had not made the refill containers concerned available to consumers, with the result that those distributors had not ‘placed them on the market’ within the meaning of the applicable legislation.

17The Minister brought an appeal against that judgment before the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry, Netherlands), the referring court.

18In the first place, that court states that it previously held, in a judgment of 9 September 2022 (ECLI:NL:CBB:2022:510), that Directive 2014/40 does not authorise the placing on the market of a tobacco product the nicotine content of which is not indicated on the packaging. The referring court adds that the administration has no discretion in that regard and cannot take into account the risks to public health where there is a discrepancy between the nicotine content in the refill container and the indication thereof on the unit packet of that container.

19However, it points out that that precedent concerned a retail outlet which placed refill containers for electronic cigarettes for sale to consumers on its own website. There was therefore ‘placing on the market’ within the meaning of the applicable national legislation and the retail outlet could be regarded as having infringed the legislation.

20By contrast, the case in the main proceedings involves the supply of refill containers by an ‘importer’, within the meaning of that legislation, that is to say, the owner of, or a person having the right of disposal over, tobacco or related products imported into the Netherlands, not to consumers but to a retail outlet. In that situation, there would therefore be uncertainty as to the interpretation of the concept of ‘placing on the market’, which constitutes the condition governing the obligation on Member States under Article 23(2) of Directive 2014/40 to ensure that tobacco and related products which do not comply with that directive are not placed on the market.

21In the second place, the referring court observes that the Secretary of State imposed administrative penalties of a criminal nature on the distributors concerned. It follows that Article 48(1) of the Charter of Fundamental Rights and, therefore, the principle nulla poena sine culpa (no punishment without fault) apply. However, that principle requires guilt and therefore liability for committing the breach in question. The question therefore arises whether those distributors are liable for having placed on the market refill containers for electronic cigarettes the unit packets of which contain an incorrect indication of their nicotine content, on account, in particular, of the potentially excessive nature of the burden which the sampling of the products concerned might represent for those distributors.

22In those circumstances, the College van Beroep voor het bedrijfsleven (Supreme Administrative Court for Trade and Industry) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:(1) Must Article 23(2) [of Directive 2014/40], read in conjunction with Article 2(40) and Article 20(4)(b)(i) of [that directive], be interpreted as meaning that the obligation on Member States to ensure that refill containers whose unit packets do not include an accurate indication of their nicotine content are not placed on the market covers not only the sale of those refill containers at or by a retail outlet, but also their supply to a retail outlet?(2) If the answer to the first question is in the affirmative, in a situation such as that at issue here where an administrative fine has been imposed, can an economic operator who has purchased refill containers from a manufacturer or importer within the meaning of Directive 2014/40 be held responsible and thus be blamed for having placed on the market refill containers whose unit packets include an incorrect indication of their nicotine content, even though the nicotine content indicated on the unit packet corresponds to the nicotine content of that refill container as stated in the notification within the meaning of Article 20(2) of [the directive]?’

Consideration of the questions referred

The first question

23By its first question, the referring court asks, in essence, whether Article 23(2) of Directive 2014/40, read in conjunction with Article 2(40) and Article 20(4)(b)(i) of that directive, must be interpreted as meaning that the obligation on Member States to ensure that refill containers for electronic cigarettes the unit packets of which do not include an accurate indication of their nicotine content are not placed on the market is limited to the stage at which those refill containers are supplied by a retail outlet to the consumer.

Admissibility

24In their written observations, the two distributors in the main proceedings submit that the first question is inadmissible on the ground that it does not correspond to the issue on which the referring court is called upon to rule in the main proceedings. According to the distributors, the Netherlands authorities do not provide for the possibility of imposing an administrative penalty on a distributor where the liquid present in a refill container for electronic cigarettes has a nicotine content lower than that indicated on the packaging and that refill container is found at a retail outlet.

25In that regard, it should be noted that, according to settled case-law, in the context of the cooperation between the Court and the national courts provided for in Article 267 TFEU, it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case, both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted by the national court concern the interpretation of EU law, the Court is, in principle, bound to give a ruling (see, to that effect, judgments of 16 December 1981, Foglia, 244/80, EU:C:1981:302, paragraph 15; of 8 November 1990, Gmurzynska-Bscher, C‑231/89, EU:C:1990:386, paragraphs 19 and 20; and of 15 July 2021, The Department for Communities in Northern Ireland, C‑709/20, EU:C:2021:602, paragraph 54).

26The Court may refuse to rule on a question referred by a national court for a preliminary ruling only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgments of 15 December 1995, Bosman, C‑415/93, EU:C:1995:463, paragraph 61, and of 15 July 2021, The Department for Communities in Northern Ireland, C‑709/20, EU:C:2021:602, paragraph 55).

27By its first question, the referring court seeks precisely to obtain an interpretation of the concept of ‘placing on the market’ in Article 23(2) of Directive 2014/40, in order to determine whether it is possible censure a distributor of refill containers for electronic cigarettes on the ground that it has sold – to a retail outlet, not to a consumer – a product which does not comply with one of the obligations of that directive.

28Accordingly, the Court holds that the first question is admissible.

Substance

29The Court recently ruled on the interpretation of the concept of ‘placing on the market’ in Article 23(2) of Directive 2014/40 by the Verwaltungsgerichtshof (Supreme Administrative Court, Austria), holding that Article 23(2) of Directive 2014/40, read in conjunction with Article 2(40) thereof, must be interpreted as meaning that the obligation of the Member States to ensure that tobacco products whose unit packet labelling infringes the requirements relating to their presentation are not placed on the market is not limited to the stage at which those products are supplied by a retail outlet to the consumer (judgment of 15 May 2025, Bundesminister für Gesundheit, C‑717/23, EU:C:2025:351, paragraph 52).

30Article 23(2) of Directive 2014/40 is cross-cutting in its scope in so far as it seeks to ensure that tobacco and related products which do not comply with any of the provisions of that directive are not placed on the market (see, to that effect, judgment of 15 May 2025, Bundesminister für Gesundheit, C‑717/23, EU:C:2025:351, paragraph 39).

31Indeed, as a means of guaranteeing the effectiveness of that provision, Article 23(3) of that directive requires the Member States to lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to that directive and to take all measures that are necessary to ensure that those penalties are enforced. The establishment of those penalties relates to all the provisions of Directive 2014/40, regardless of the stage of the supply chain to which those provisions apply, and is thus not limited to the stage at which a retail outlet supplies non-compliant tobacco products to consumers (judgment of 15 May 2025, Bundesminister für Gesundheit, C‑717/23, EU:C:2025:351, paragraph 40).

32That interpretation, according to which the Member States’ obligation is imposed at any stage of the supply chain, without being limited solely to the stage of the supply of tobacco products by a retail outlet to consumers, is also supported by the broader regulatory context of Directive 2014/40, Regulation 2019/1020 in particular, which applies, in accordance with Article 2 of, and point 55 of Annex I to, that regulation, to products which fall within the scope of Directive 2014/40 (see, to that effect, judgment of 15 May 2025, Bundesminister für Gesundheit, C‑717/23, EU:C:2025:351, paragraphs 42 to 46).

33In addition, in order for the objective of guaranteeing a high level of health and consumer protection, provided for in Article 1 of that directive, read in the light of recitals 8 and 59 of the directive, to be attained, that enforcement obligation presupposes surveillance at the various stages of the supply chain, requiring Member States to ensure that the requirements of the directive are met whenever a transaction takes place which leads to the product ultimately being made available to consumers (judgment of 15 May 2025, Bundesminister für Gesundheit, C‑717/23, EU:C:2025:351, paragraph 51).

34The fact that the dispute in the main proceedings concerns the sale of refill containers for electronic cigarettes does not alter the interpretation of Article 23(2) of Directive 2014/40 set out in paragraph 29 of the present judgment. On the contrary, Article 20 of the directive, concerning electronic cigarettes exclusively, insists expressly in paragraph 1 on the Member States’ obligation to ensure that ‘electronic cigarettes and refill containers are only placed on the market if they comply with [the directive] and with all other relevant Union legislation’.

35In the light of the foregoing considerations, the answer to the first question is that Article 23(2) of Directive 2014/40, read in conjunction with Article 2(40) and Article 20(4)(b)(i) of that directive, must be interpreted as meaning that the obligation on Member States to ensure that refill containers for electronic cigarettes the unit packets of which do not include an accurate indication of their nicotine content are not placed on the market is not limited to the stage at which those refill containers are supplied by a retail outlet to the consumer.

The second question

36As a preliminary point, it should be noted that, as worded by the referring court, the second question does not refer to any provision of EU law.

37That said, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court, it is for the latter to provide the national court with an answer which will be of use to it and enable it to decide the case before it. To that end, the Court may also find it necessary to consider provisions of EU law which the national court has not referred to in its questions (see, to that effect, judgments of 20 March 1986, Tissier, 35/85, EU:C:1986:143, paragraph 9, and of 4 October 2024, Confédération paysanne (Melons and tomatoes from Western Sahara), C‑399/22, EU:C:2024:839, paragraph 40).

38In the present case, it is apparent from the request for a preliminary ruling that the penalties which are the subject of the dispute in the main proceedings fall within the system of penalties which the Member States are required to adopt on the basis of Article 23(3) of Directive 2014/40.

39In those circumstances, the Court considers that, by its second question, the referring court is asking, in essence, whether Article 23(3) of Directive 2014/40 must be interpreted as precluding national legislation which provides for an administrative fine of a criminal nature to penalise an economic operator which has placed on the market refill containers the unit packets of which do not include correct information on their nicotine content, even though that information corresponds to that in the notification made under Article 20(2) of the directive by the ‘manufacturer’ or ‘importer’ from which that operator acquired those containers.

40It is apparent from the wording of Article 23(3) of Directive 2014/40, first, that Member States are to lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to the directive; second, that those penalties must be effective, proportionate and dissuasive, and, third, that any financial administrative penalty which may be imposed as a result of an intentional infringement may be such as to offset the financial advantage sought through the infringement.

41Save for the last clarification, which makes the possibility of offsetting the financial advantage sought subject to the intentional nature of that infringement, Directive 2014/40 does not therefore contain any rules relating to the establishment of the applicable system of penalties other than that requiring those penalties to be effective, proportionate and dissuasive. It may thus be inferred from the wording of Article 23(3) of that directive that, subject to compliance with that requirement, the Member States retain their autonomy in determining that regime.

42In the absence of harmonisation of EU legislation in the field of penalties applicable where conditions laid down by arrangements under that legislation are not complied with, Member States are empowered to choose the penalties which seem to them to be appropriate. They must, however, exercise that power in accordance with EU law and its general principles, and consequently in accordance with the principle of proportionality (judgments of 9 February 2012, Urbán, C‑210/10, EU:C:2012:64, paragraph 23; of 22 March 2017, Euro-Team and Spirál-Gép, C‑497/15 and C‑498/15, EU:C:2017:229, paragraph 39; and of 21 November 2024, Еkоstroy, C‑61/23, EU:C:2024:974, paragraph 41).

43As is apparent from the request for a preliminary ruling, the uncertainty underlying the second question is whether a system of strict liability is compatible with the requirement laid down in Article 23(3) of Directive 2014/40 and, in particular, compliance with the principle of proportionality.

44Regarding that principle, it follows from the Court’s case-law that such a system is not in itself incompatible with EU law (see, to that effect, judgments of 10 July 1990, Hansen, C‑326/88, EU:C:1990:291, paragraph 19; of 27 February 1997, Ebony Maritime and Loten Navigation, C‑177/95, EU:C:1997:89, paragraph 36; of 11 July 2002, Käserei Champignon Hofmeister, C‑210/00, EU:C:2002:440, paragraph 47; and of 9 February 2012, Urbán, C‑210/10, EU:C:2012:64, paragraph 47).

45Indeed, a system of strict liability is not disproportionate if that system is such as to encourage the persons concerned to comply with the provisions of an EU measure and where the objective pursued is a matter of public interest which may justify the introduction of such a system (see, to that effect, judgments of 10 July 1990, Hansen, C‑326/88, EU:C:1990:291, paragraph 19, and of 9 February 2012, Urbán, C‑210/10, EU:C:2012:64, paragraph 48).

46In the present case, first, as recalled in paragraph 33 of the present judgment, Directive 2014/40 pursues, according to Article 1 thereof, the objective of ensuring a high level of health protection, of young people in particular.

47Such an objective is a matter of public interest within the meaning of the case-law referred to in paragraph 45 of the present judgment (see, to that effect, judgments of 6 September 2012, Deutsches Weintor, C‑544/10, EU:C:2012:526, paragraph 49, and of 29 April 2015, Léger, C‑528/13, EU:C:2015:288, paragraph 57), which may justify the introduction by the Member States of a system of strict liability. Such a system is, moreover, such as to encourage the persons concerned to comply with the obligations arising from Directive 2014/40.

48Furthermore, as regards the particular circumstance that the nicotine levels which gave rise to the penalties in question in the main proceedings are consistent with those notified by the manufacturer and importers of the products at issue on the basis of Article 20(2) of that directive, it must be stated that that notification is intended, in accordance with recital 13 of that directive, to facilitate the regulatory tasks of the Member States and the Commission, not to enable economic operators intervening downstream to avoid liability.

49Second, those penalties do not appear to be capable of offsetting the economic advantage sought through the infringement, which it is for the referring court to ascertain. In such a case, those penalties would not require proof of intent on the basis of Article 23(3) of Directive 2014/40.

50In such circumstances, Member States may therefore adopt national legislation which provides for an administrative fine of a criminal nature to penalise an economic operator which has placed on the market refill containers for electronic cigarettes the unit packets of which do not include correct information on their nicotine content, even though that information corresponds to that in the notification made within the meaning of Article 20(2) of Directive 2014/40 by the ‘manufacturer’ or ‘importer’ from which that operator acquired those containers.

51That said, although the Member States are required to comply with the principle of proportionality in determining the factors constituting an infringement, this is also the case where they must assess the relevant factors for fixing a fine (see, to that effect, judgments of 9 February 2012, Urbán, C‑210/10, EU:C:2012:64, paragraph 54; of 22 March 2017, Euro-Team and Spirál-Gép, C‑497/15 and C‑498/15, EU:C:2017:229, paragraph 43, and of 21 November 2024, Еkоstroy, C‑61/23, EU:C:2024:974, paragraph 46).

52This means that the individual circumstances of the particular case must be taken into account in fixing the amount of the fine (see, to that effect, judgments of 4 October 2018, Link Logistik N&N, C‑384/17, EU:C:2018:810, paragraph 45, and of 21 November 2024, Ekostroy, C‑61/23, EU:C:2024:974, paragraph 47). For that reason, the imposition of flat-rate fines for all breaches of certain obligations laid down by national legislation, without adjustment of the amount of the penalty in line with the seriousness of the breach, may appear to be disproportionate in the light of the objectives pursued by the EU legislation (see, to that effect, judgments of 9 February 2012, Urbán, C‑210/10, EU:C:2012:64, paragraph 41, and of 22 March 2017, Euro-Team and Spirál-Gép, C‑497/15 and C‑498/15, EU:C:2017:229, paragraph 50).

53In the present case, subject to the assessments which fall within the jurisdiction of the referring court, the national legislation at issue in the main proceedings does not appear to allow those penalties to be tailored. It is apparent from the request for a preliminary ruling and the observations submitted to the Court that the amount of the fines imposed on the two distributors in question is independent of the individual circumstances of the case and, in particular, of the fact that the indication of the nicotine content of which they are accused is higher than that actually contained in the refill containers placed on the market.

54It follows that the imposition of a flat-rate financial penalty for all breaches of certain obligations laid down by national legislation pursuant to Directive 2014/40, without adjustment of the amount of the financial penalty in line with the seriousness of the breach, as appears to be provided for under the system of penalties at issue in the main proceedings, is disproportionate in the light of the objective pursued by Directive 2014/40, that is, of ensuring a high level of health protection, of young people in particular (see, by analogy, judgments of 22 March 2017, Euro-Team and Spirál-Gép, C‑497/15 and C‑498/15, EU:C:2017:229, paragraphs 62 to 64 and 66, and of 21 November 2024, Еkоstroy, C‑61/23, EU:C:2024:974, paragraph 53).

55In the light of the foregoing, the answer to the second question is that Article 23(3) of Directive 2014/40 must be interpreted as precluding national legislation which provides for an administrative fine of a criminal nature to penalise an economic operator which has placed on the market refill containers whose unit packets do not include correct information on their nicotine content, even though that information corresponds to that in the notification made within the meaning of Article 20(2) of the directive by the ‘manufacturer’ or ‘importer’ from which that operator acquired those containers, where the amount of that fine cannot be adjusted according to the seriousness of the breach, taking into account the individual circumstances of the case.

Costs

56Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

Operative part

On those grounds, the Court (Seventh Chamber) hereby rules:

1.Article 23(2) 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, read in conjunction with Article 2(40) and Article 20(4)(b)(i) of that directive,must be interpreted as meaning that the obligation on Member States to ensure that refill containers for electronic cigarettes the unit packets of which do not include an accurate indication of their nicotine content are not placed on the market is not limited to the stage at which those refill containers are supplied by a retail outlet to the consumer.

2.Article 23(3) of Directive 2014/40must be interpreted as precluding national legislation which provides for an administrative fine of a criminal nature to penalise an economic operator which has placed on the market refill containers whose unit packets do not include correct information on their nicotine content, even though that information corresponds to that in the notification made within the meaning of Article 20(2) of the directive by the ‘manufacturer’ or ‘importer’ from which that operator acquired those containers, where the amount of that fine cannot be adjusted according to the seriousness of the breach, taking into account the individual circumstances of the case.