Source: EURLEX
Language: en
Format: md

Provisional text

JUDGMENT OF THE COURT (First Chamber)

17 October 2024 ([\*](#Footnote*))

( Reference for a preliminary ruling – Services in the internal market – Directive 2006/123/EC – Authorisation scheme – Article 10 – Conditions for the granting of authorisation – Sale of tobacco products – National legislation making the grant of authorisation to establish a point of sale for tobacco products subject to compliance with conditions – Conditions relating to distance and population – Protection of public health against smoking )

In Case C‑16/23,

REQUEST for a preliminary ruling under Article 267 TFEU from the Tribunale amministrativo regionale per la Liguria (Regional Administrative Court, Liguria, Italy), made by decision of 22 December 2022, received at the Court on 16 January 2023, in the proceedings

**FA.RO. di YK & C. Sas**

v

**Agenzia delle Dogane e dei Monopoli,**

intervener:

**JS,**

THE COURT (First Chamber),

composed of T. von Danwitz, Vice-President of the Court, acting as President of the First Chamber, A. Arabadjiev and I. Ziemele (Rapporteur), Judges,

Advocate General: M. Campos Sánchez-Bordona,

Registrar: C. Di Bella, Administrator,

having regard to the written procedure and further to the hearing on 24 January 2024,

after considering the observations submitted on behalf of:

–        FA.RO. di YK & C. Sas, by G. Briozzo, avvocato,

–        JS, by A. Celotto and L. Grazzini, avvocati,

–        the Italian Government, by G. Palmieri, acting as Agent, and by D. Del Gaizo and F. Meloncelli, avvocati dello Stato,

–        the Spanish Government, by M. Morales Puerta, acting as Agent,

–        the European Commission, by L. Armati, L. Malferrari and M. Mataija, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 14 March 2024,

gives the following

**Judgment**

1        This request for a preliminary ruling concerns the interpretation of Articles 49 and 56 and Article 106(2) TFEU and Article 15 of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ 2006 L 376, p. 36).

2        The request has been made in proceedings between FA.RO. di YK & C. Sas (‘FA.RO.’), a company incorporated under Italian law, and the Agenzia delle Dogane e dei Monopoli (Customs and Monopolies Authority, Italy) (‘the ADM’) concerning the refusal of a request for the establishment of a new point of sale for manufactured tobacco products.

**Legal context**

***Inter****national law***

3        The preamble to the World Health Organisation Framework Convention on Tobacco Control (‘the FCTC’), adopted by the World Health Assembly on 21 May 2003 in Geneva, to which the European Union and its Member States are party, recognises that ‘scientific evidence has unequivocally established that tobacco consumption and exposure to tobacco smoke cause death, disease and disability’ and that ‘cigarettes and some other products containing tobacco are highly engineered so as to create and maintain dependence, and that many of the compounds they contain and the smoke they produce are pharmacologically active, toxic, mutagenic and carcinogenic, and that tobacco dependence is separately classified as a disorder in major international classifications of diseases’.

4        Articles 8 to 13 of the FCTC deal with measures relating to the reduction of demand for tobacco. They concern, respectively: protection from exposure to tobacco smoke; regulation of the contents of tobacco products; regulation of tobacco product disclosures; packaging and labelling of tobacco products; education and public awareness of tobacco control issues; and a comprehensive ban on tobacco advertising, promotion and sponsorship. Article 14 of that convention provides for demand reduction measures concerning tobacco dependence and measures to promote cessation, while Articles 15 to 17 of that convention, which deal with measures relating to the reduction of the supply of tobacco, concern respectively the illicit trade in tobacco products, sales to and by minors, and the provision of support for economically viable alternative activities.

***European Union law***

5        Recitals 2, 5, 7, 8 and 66 of Directive 2006/123 state:

‘(2)      A competitive market in services is essential in order to promote economic growth and create jobs in the European Union. … A free market which compels the Member States to eliminate restrictions on cross-border provision of services while at the same time increasing transparency and information for consumers would give consumers wider choice and better services at lower prices.

…

(5)      It is therefore necessary to remove barriers to the freedom of establishment for providers in Member States and barriers to the free movement of services as between Member States and to guarantee recipients and providers the legal certainty necessary for the exercise in practice of those two fundamental freedoms of the Treaty. …

…

(7)      This Directive establishes a general legal framework which benefits a wide variety of services while taking into account the distinctive features of each type of activity or profession and its system of regulation. … This Directive also takes into account other general interest objectives, including the protection of the environment, public security and public health as well as the need to comply with labour law.

(8)      It is appropriate that the provisions of this Directive concerning the freedom of establishment and the free movement of services should apply only to the extent that the activities in question are open to competition, so that they do not oblige Member States either to liberalise services of general economic interest or to privatise public entities which provide such services or to abolish existing monopolies for other activities or certain distribution services.

…

(66)      Access to or the exercise of a service activity in the territory of a Member State should not be subject to an economic test. The prohibition of economic tests as a prerequisite for the grant of authorisation should cover economic tests as such, but not requirements which are objectively justified by overriding reasons relating to the public interest, such as the protection of the urban environment, social policy or public health. The prohibition should not affect the exercise of the powers of the authorities responsible for applying competition law.’

6        Article 1(1) to (3) of that directive states:

‘1.      This Directive establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services.

2.      This Directive does not deal with the liberalisation of services of general economic interest, reserved to public or private entities, nor with the privatisation of public entities providing services.

3.      This Directive does not deal with the abolition of monopolies providing services nor with aids granted by Member States which are covered by Community rules on competition.

This Directive does not affect the freedom of Member States to define, in conformity with Community law, what they consider to be services of general economic interest, how those services should be organised and financed, in compliance with the State aid rules, and what specific obligations they should be subject to.’

7        Article 2(1) and (2) of that directive is worded as follows:

‘1.      This Directive shall apply to services supplied by providers established in a Member State.

2.      This Directive shall not apply to the following activities:

(a)      non-economic services of general interest;

…’

8        Article 4 of the same directive provides:

‘For the purposes of this Directive, the following definitions shall apply:

…

(6)      “authorisation scheme” means any procedure under which a provider or recipient is in effect required to take steps in order to obtain from a competent authority a formal decision, or an implied decision, concerning access to a service activity or the exercise thereof;

(7)      “requirement” means any obligation, prohibition, condition or limit provided for in the laws, regulations or administrative provisions of the Member States or in consequence of case-law, administrative practice, the rules of professional bodies, or the collective rules of professional associations or other professional organisations, adopted in the exercise of their legal autonomy; rules laid down in collective agreements negotiated by the social partners shall not as such be seen as requirements within the meaning of this Directive;

(8)      “overriding reasons relating to the public interest” means reasons recognised as such in the case-law of the Court of Justice, including the following grounds: public policy; public security; public safety; public health; preserving the financial equilibrium of the social security system; the protection of consumers, recipients of services and workers; fairness of trade transactions; combating fraud; the protection of the environment and the urban environment; the health of animals; intellectual property; the conservation of the national historic and artistic heritage; social policy objectives and cultural policy objectives;

…’

9        Article 9(1) of Directive 2006/123 states:

‘Member States shall not make access to a service activity or the exercise thereof subject to an authorisation scheme unless the following conditions are satisfied:

(a)      the authorisation scheme does not discriminate against the provider in question;

(b)      the need for an authorisation scheme is justified by an overriding reason relating to the public interest;

(c)      the objective pursued cannot be attained by means of a less restrictive measure, in particular because an a posteriori inspection would take place too late to be genuinely effective.’

10      Under Article 10(1) and (2) of that directive:

‘1.      Authorisation schemes shall be based on criteria which preclude the competent authorities from exercising their power of assessment in an arbitrary manner.

2.      The criteria referred to in paragraph 1 shall be:

(a)      non-discriminatory;

(b)      justified by an overriding reason relating to the public interest;

(c)      proportionate to that public interest objective;

(d)      clear and unambiguous;

(e)      objective;

(f)      made public in advance;

(g)      transparent and accessible.’

11      Article 14 of that directive provides:

‘Member States shall not make access to, or the exercise of, a service activity in their territory subject to compliance with any of the following:

…

(5)      the case-by-case application of an economic test making the granting of authorisation subject to proof of the existence of an economic need or market demand, an assessment of the potential or current economic effects of the activity or an assessment of the appropriateness of the activity in relation to the economic planning objectives set by the competent authority; this prohibition shall not concern planning requirements which do not pursue economic aims but serve overriding reasons relating to the public interest;

…’

12      Article 15(1) to (4) of Directive 2006/123 provides:

‘1.      Member States shall examine whether, under their legal system, any of the requirements listed in paragraph 2 are imposed and shall ensure that any such requirements are compatible with the conditions laid down in paragraph 3. Member States shall adapt their laws, regulations or administrative provisions so as to make them compatible with those conditions.

2.      Member States shall examine whether their legal system makes access to a service activity or the exercise of it subject to compliance with any of the following non-discriminatory requirements:

(a)      quantitative or territorial restrictions, in particular in the form of limits fixed according to population or of a minimum geographical distance between providers;

…

3.      Member States shall verify that the requirements referred to in paragraph 2 satisfy the following conditions:

(a)      non-discrimination: requirements must be neither directly nor indirectly discriminatory according to nationality nor, with regard to companies, according to the location of the registered office;

(b)      necessity: requirements must be justified by an overriding reason relating to the public interest;

(c)      proportionality: requirements must be suitable for securing the attainment of the objective pursued; they must not go beyond what is necessary to attain that objective and it must not be possible to replace those requirements with other, less restrictive measures which attain the same result.

4.      Paragraphs 1, 2 and 3 shall apply to legislation in the field of services of general economic interest only in so far as the application of these paragraphs does not obstruct the performance, in law or in fact, of the particular task assigned to them.’

***Italian law***

*Law No 1293/1957*

13      Article 16 of legge No 1293 – Organizzazione dei servizi di distribuzione e vendita dei generi di monopolio (Law No 1293 on the organisation of services for the distribution and sale of monopoly goods) of 22 December 1957 (GURI No 9 of 13 January 1958), in the version applicable to the facts in the main proceedings (‘Law No 1293/1957’) provides:

‘The sale to the public of monopoly goods shall be carried out through points of sale and licences.

The points of sale referred to in the first subparagraph shall be established by the regional office in accordance with the criteria and procedures laid down by decision of the Director-General of the Autonomous Administration of State Monopolies.’

14      Article 19 of that law provides:

‘Among the points of sale in which monopoly goods are sold, a distinction is made between:

…

(b)      ordinary points of sale;

(c)      special points of sale.

…

The second shall be awarded to individuals under a concession or a management arrangement for a period not exceeding nine years.

…’

15      Pursuant to Article 21(1) of that Law:

‘Ordinary points of sale shall be established where and when the authorities consider it useful and appropriate in the interest of the service.

In municipalities with a population of no more than 30 000 inhabitants, newly established ordinary points of sale shall be awarded on a trial basis by way of competition solely for military personnel wounded in warfare and war widows, as well as to categories of persons treated as such by law and to persons decorated for military merit.

In the other municipalities and in provincial capitals, ordinary points of sale shall be awarded on a trial basis by public adjudication.

The point of sale shall be awarded to the bidder who meets the criteria set out in the adjudication notice and who offers the highest fee.

The trial period referred to in the preceding subparagraphs shall be three years, at the end of which the point of sale, if not terminated, is classified as covered by Article 25 and may be awarded by private agreement or directly to the incumbent.’

16      It is also apparent from Law No 1293/1957, first, that special points of sale are to be established to meet demand needs in specific places and, second, that the authorities may grant authorisation to sell products subject to a monopoly, in particular in premises for the sale of beverages, by means of a licence. In the latter case, the licence holder shall obtain his or her supplies from the nearest ordinary point of sale.

*Decree-Law No 98/2011*

17      Article 24(42) of decreto-legge No 98 – Disposizioni urgenti per la stabilizzazione finanziaria (Decree-Law No 98 – Urgent measures for financial stability) of 6 July 2011 (GURI No 155 of 6 July 2011), converted into law, with amendments, by Law No 111 of 15 July 2011 (GURI No 164 of 16 July 2011), in the version applicable to the facts in the main proceedings (‘Decree-Law No 98/2011’), provides:

‘By legislation adopted before 31 March 2013 … the Minister for Economic Affairs and Finance shall lay down provisions concerning the arrangements for the establishment of ordinary and special points of sale for monopoly products, and the issue and renewal of the licence, in accordance with the following principles:

(a)      the optimisation and rationalisation of the sales network, including by laying down criteria designed to regulate the location of points of sale, in order to balance, while also protecting competition, the requirement to ensure that users have access to a sales network which is well distributed across the territory against the fundamental public interest in health protection, consisting in preventing and controlling any supply of tobacco to the public that is not justified by the actual demand for tobacco products;

(b)      ordinary points of sale may be established only if precise requirements are met as to the distance, namely a distance of not less than 200 metres, and as to the population, namely a ratio of one outlet for every 1 500 inhabitants;

(c)      …;

(d)      transfers of ordinary points of sale shall be possible only if the same conditions of distance and, where applicable, of population referred to in point (b) apply;

(e)      the establishment of special points of sale is possible only if there is an objective and real need for a service, which must be assessed on the basis of the actual location of the other points of sale already in existence in the same reference area, as well as on the basis of the requirements referred to in subparagraph (b);

(f)      the issue and renewal of licences must be assessed on the basis of their complementarity and the absence of overlap with points of sale of monopoly products, including by identifying and applying the criterion of distance.’

*Ministerial Decree No 38/2013*

18      Article 2(1) to (3) of decreto ministeriale no 38 – Regolamento recante disciplina della distribuzione e vendita dei prodotti da fumo (Ministerial Decree No 38 laying down rules governing the distribution and sale of smoking products) of 21 February 2013 (GURI No 89 of 16 April 2013), in the version applicable to the facts in the main proceedings (‘Ministerial Decree No 38/2013’), adopted under Article 24(42) of Decree-Law No 98/11, states:

‘1.      The establishment of ordinary points of sale shall be authorised where the parameters referred to in this article are complied with.

2.      The minimum distance of the premises intended for the new point of sale from the nearest point of sale already operating is equal to or greater than:

(a)      300 metres (m) in municipalities with a population of 30 000 inhabitants or fewer;

(b)      250 m in municipalities with a population of between 30 001 and 100 000 inhabitants;

(c)      200 m in municipalities with a population of more than 100 000 inhabitants;

3.      The establishment of a new point of sale shall not be authorised if the ratio of one point of sale for 1 500 inhabitants is already reached in the municipalities concerned, except in municipalities with fewer than 1 500 inhabitants where there is no point of sale, where a real and specific interest of the service can be established and the nearest ordinary point of sale already operating in another municipality is over 600 m away.’

19      In accordance with Article 3(1) to (6) of that ministerial decree:

‘1.      Under Article 21 of Law [No 1293/1957], ordinary points of sale shall be established by decision of the competent offices of the [ADM] within the time limits and at places determined in the light of the interest of the service, taking particular account of the areas where there are new residential and commercial developments, the specific importance of road junctions and the major urban meeting places of the resident population and also the presence of offices and production structures that are particularly important and well-used which might demonstrate an interest of the service, as well as transfer requests received by the offices.

2.      For the purposes of paragraph 1, the competent offices shall adopt, for each calendar year, two six-month plans for the establishment of ordinary points of sale, taking into account, with regard to existing points of sale and transfer requests received in the intervening period, the need for the sales network for manufactured tobacco to be:

(a)      adapted to the interest of the service;

(b)      organised in such a way as to ensure the efficiency and effectiveness of the checks carried out by the authorities for the protection of minors, public policy and public security, public health and revenue.

3.      When drawing up each plan, transfer requests and proposals for new points of sale received by the authorities during the immediately preceding six-month period shall be evaluated. Proposals to establish new points of sale do not create any rights for those who formulate them or obligations for the authorities.

4.      The competent office shall draw up, before 31 March and before 30 September, the draft plan for the establishment of new ordinary points of sale, ensuring that only proposals for new points of sale for which there is a need for a service are included, in compliance with the parameters referred to in Article 2 and in the light of all other useful assessment material.

5.      For each draft six-month plan, by 30 April and 31 October at the latest, the competent office … shall make the draft plan public in a specific section of the institutional site of the [ADM]. …

6.      Once the draft plan has been drawn up in the light of all the material obtained in the assessment, the competent office shall notify the opening of the procedure for the establishment of new points of sale to the owners of the three nearest points of sale situated at a distance of less than 600 m from the seat of the new point of sale, giving them a period of 15 days to submit any observations. At the end of that period, in the light of all the material obtained in the assessment, the competent office shall approve the final establishment plan for the new points of sale and, for each area designated as appropriate for that establishment, publish the award notice pursuant to Article 21 of Law [No 1293/1957] …’.

20      In accordance with Article 7 of Ministerial Decree No 38/2013, licences must be justified by the need to provide the service in places and at times where it cannot be provided by ordinary points of sale. The possibility of granting a licence is excluded where, at the nearest point of sale, situated at a distance below predetermined limits, a vending machine selling manufactured tobacco products is installed.

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

21      FA.RO. carries on a commercial restaurant and bar business in the municipality of Finale Ligure (Italy). It held a licence for the retail sale in its establishment of products subject to a State monopoly. By document of 19 November 2021, the ADM initiated a procedure for the revocation of that licence on the ground that the main point of sale to which the licence was linked in terms of tobacco supply, located less than 300 m away, had installed a cigarette vending machine, which prevented that licence from being maintained, in accordance with Article 7 of Ministerial Decree No 38/2013.

22      FA.RO. then submitted a request to set up a new ordinary point of sale in its establishment, explaining that the need for that point of sale arose from high consumer footfall.

23      On 31 March 2022, the ADM adopted memorandum No 6401/RU containing the draft six-month plan for the establishment of new ordinary points of sale in Liguria published on 6 April 2022. The establishment of the point of sale requested by FA.RO was not included in that draft six-month plan on the ground that the conditions relating to distance and population size, laid down in Article 2 of Ministerial Decree No 38/2013, were not satisfied. First, the proposed premises were situated 176 m and 220 m from two other points of sale respectively. Second, there were already 13 active ordinary and special points of sale in Finale Ligure for a population of 11 358 inhabitants.

24      FA.RO. brought an action before the Tribunale amministrativo regionale per la Liguria (Regional Administrative Court, Liguria, Italy), the referring court, challenging that draft six-month plan and the final plan, in so far as they did not provide for the establishment of the point of sale that FA.RO. had requested. That company claimed, inter alia, that a new point of sale in its establishment would not result in an inflated supply as compared to demand, since there are 100 times more actual users of the service than there are inhabitants, owing to the mass influx of visitors at weekends and during the tourist season. In those circumstances, ADM should not have automatically applied the parameters laid down by the relevant national legislation, but should have verified the necessity and proportionality of the restrictions imposed on free access to the services market and disapplied Article 24(42) of Decree-Law No 98/2011 and Article 2 of Ministerial Decree No 38/2013, since they are contrary to Article 15(1) and (2) of Directive 2006/123.

25      The referring court notes that the request referred to in paragraph 22 above was rejected on the ground of non-compliance with the criteria laid down *in abstracto* by the relevant national legislation, without assessing the evidence provided by that company, according to which the trade in tobacco products at the requested point of sale would not encourage increased demand but, on the contrary, would meet a pre-existing, substantial service need.

26      However, the conditions relating to distance and population size laid down by that national legislation constitute territorial and quantitative restrictions within the meaning of Article 15(2)(a) of Directive 2006/123 and might not be compatible with the criteria laid down in Article 15(3) of that directive.

27      In that regard, the referring court states that the overriding reason which led the national legislature to impose such restrictive measures is the protection of human health against the risks generated by tobacco products. However, it does not appear that those restrictions are actually appropriate for discouraging or, at least, not encouraging the consumption of tobacco products, on account, in particular, of the ever greater distribution of vending machines, which may be installed by the operators of authorised points of sales, with the result that cigarettes are permanently accessible to the consumer. Furthermore, in order for the reduction in the number of points of sales on the territory to have a dissuasive effect, the minimum distances between tobacco stores must be fixed in kilometres and not in metres.

28      The need for criteria based on distance and population size does not derive from the FCTC either. Moreover, it is apparent from a report of the Autorità Garante della Concorrenza e del Mercato (Competition and Market Authority, Italy), first, that the restrictive measures at issue in the main proceedings are intended less to protect the health of citizens than to ensure the profitability of the activity and, second, that minimum distances and any form of planning of the structure of the supply should be abolished.

29      In any event, those restrictions could prove to be excessive in the light of the objective of health protection by means of a balanced relationship between supply and demand, on account of their rigidity and the link with data taken purely from the population registry record.

30      Thus, according to the referring court, the ADM should be in a position to assess any objective circumstances which demonstrate that, despite non-compliance with the conditions relating to distance and population size, the establishment of a new ordinary point of sale would meet the needs of a service and, consequently, would not lead to an inflated supply, in particular where, as in the present case, the size of the consumer pool is much larger than the resident population alone because of the high level of tourism.

31      In those circumstances the Tribunale amministrativo regionale per Liguria (Regional Administrative Court, Ligura) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1)      Must Article 15 of [Directive 2006/123] and Articles 49, 56 and [Article] 106(2) TFEU be interpreted as precluding national legislation, such as that at issue in the main proceedings, which imposes restrictions on the authorisation of tobacco product outlets according to a minimum geographical distance between providers and according to the resident population?

(2)      Must Article 15 of [Directive 2006/123] and Articles 49, 56 and [Article] 106(2) TFEU be interpreted as precluding national legislation, such as that at issue in the main proceedings, which makes the authorisation of tobacco product outlets subject to compliance with pre-established criteria relating to the minimum geographical distance between suppliers and to the resident population, without allowing the competent public authority to assess other objective factual circumstances that demonstrate, even where the above-mentioned conditions are not satisfied[,] a need for a service in the case at issue?’

**Admissibility of the request for a preliminary ruling**

32      The Spanish Government submits, in essence, that the request for a preliminary ruling is inadmissible on the ground that none of the provisions, the interpretation of which is sought, is applicable to the situation at issue in the main proceedings. For its part, the Italian Government, without formally raising a plea of inadmissibility, disputes the applicability of Directive 2006/123 to the present situation, relying on Article 2(1) and (2) of that directive.

33      In that regard, it must be noted that, in the context of the cooperation between the Court of Justice 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 of Justice. Consequently, where the questions submitted concern the interpretation of EU law, the Court is, in principle, bound to give a ruling (judgment of 8 May 2024, *Instituto da Segurança Social and Others*, C‑20/23, EU:C:2024:389, paragraph 24 and the case-law cited).

34      It follows that questions concerning EU law enjoy a presumption of relevance. The Court may refuse to rule on a question referred by a national court only where it is quite obvious that the interpretation of a rule of EU law 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 (judgment of 8 May 2024, *Instituto da Segurança Social and Others,*  C‑20/23, EU:C:2024:389, paragraph 25 and the case-law cited).

35      According to the Court’s settled case-law, in the context of the cooperation between the Court of Justice and the national courts, the need to provide an interpretation of EU law which will be of use to the national court means that the national court is bound to observe scrupulously the requirements concerning the content of a request for a preliminary ruling, expressly set out in Article 94 of the Rules of Procedure of the Court of Justice (judgment of 28 November 2023, *Commune d’Ans*, C‑148/22, EU:C:2023:924, paragraph 46 and the case-law cited).

36      Thus, it is, in particular, essential, in accordance with Article 94(c) of the Rules of Procedure, that the order for reference contain a statement of the reasons which prompted the national court to inquire about the interpretation or validity of certain provisions of EU law, and the relationship between those provisions and the national legislation applicable to the main proceedings (judgment of 28 November 2023, *Commune d’Ans*, C‑148/22, EU:C:2023:924, paragraph 46 and the case-law cited).

37      In the present case, the referring court seeks an interpretation from the Court of Articles 49, 56 and Article 106(2) TFEU and of Article 15 of Directive 2006/123.

38      As regards, first, Articles 49 and 56 of the TFEU, it should be borne in mind that the provisions of the FEU Treaty on the freedom of establishment, the freedom to provide services and the free movement of capital do not, in principle, apply to a situation which is confined in all respects within a single Member State (judgments of 15 November 2016, *Ullens de Schooten*, C‑268/15, EU:C:2016:874, paragraph 47 and the case-law cited, and of 18 January 2022, *Thelen Technopark Berlin*, C‑261/20, EU:C:2022:33, paragraph 50).

39      The Court, on a question being referred to it by a national court in connection with a situation which is confined in all respects within a single Member State, cannot, where the referring court gives no indication to that effect, consider that a request for a preliminary ruling concerning the interpretation of the provisions of the FEU Treaty relating to the fundamental freedoms is necessary for the purpose of resolving the dispute pending before that court. The specific factors that allow a link to be established between the subject matter or circumstances of a dispute, which is confined in all respects within the Member State concerned, on the one hand, and Articles 49 and 56 TFEU, on the other, must be apparent from the order for reference (see, to that effect, judgments of 15 November 2016, *Ullens de Schooten*, C‑268/15, EU:C:2016:874, paragraph 54, and of 18 January 2022, *Thelen Technopark Berlin*, C‑261/20, EU:C:2022:33, paragraph 52).

40      Consequently, in a situation which is confined in all respects within a single Member State, it is for the referring court to indicate to the Court, in accordance with the requirements of Article 94 of the Rules of Procedure of the Court, in what way the dispute pending before it, despite its purely domestic character, has a connecting factor with the provisions of EU law on the fundamental freedoms that makes the preliminary ruling on interpretation necessary for it to give judgment in that dispute (see, to that effect, judgments of 15 November 2016, *Ullens de Schooten*, C‑268/15, EU:C:2016:874, paragraph 55, and of 18 January 2022, *Thelen Technopark Berlin*, C‑261/20, EU:C:2022:33, paragraph 53).

41      In the first place, it is apparent from the order for reference that all the factors characterising the dispute in the main proceedings are confined within a single Member State, in this case the Italian Republic. Second, that order for reference contains nothing to suggest that, despite its purely domestic character, the subject matter of that dispute has a connecting factor with Articles 49 and 56 TFEU that would make the interpretation thereof necessary for it to give judgment in that dispute.

42      Consequently, the questions referred for a preliminary ruling are inadmissible, in so far as they concern the interpretation of Articles 49 and 56 TFEU.

43      As regards, in the second place, Article 106(2) TFEU, it should be borne in mind, first, that that provision provides that undertakings entrusted with the operation of services of general economic interest or having the character of a revenue-producing monopoly are to be subject to the rules on competition, in so far as the application of such rules does not obstruct the performance, in law or in fact, of the particular tasks assigned to them and, second, that it seeks to reconcile the Member States’ interests in using certain undertakings as an instrument of economic or social policy with the European Union’s interest in ensuring compliance with the rules on competition and the preservation of the unity of the internal market (judgment of 24 November 2020, *Viasat Broadcasting UK*, C‑445/19, EU:C:2020:952, paragraph 30 and the case-law cited).

44      By merely stating that the conditions relating to distance and population size constitute restrictions affecting the fundamental rights and freedoms guaranteed in Article 106(2) TFEU, the referring court does not set out the link which it establishes between that provision and the national legislation at issue in the main proceedings.

45      Therefore, the questions referred for a preliminary ruling are also inadmissible in so far as they concern the interpretation of Article 106(2) TFEU.

46      As regards, in the third place, the interpretation of Directive 2006/123, the referring court notes that the conditions relating to distance and population size, laid down by the national legislation, could constitute territorial and quantitative restrictions within the meaning of Article 15(2)(a) of that directive. If that were to be the case, that court questions whether those conditions are consistent with Article 15(3) of that directive and to that end provides an analysis of those conditions in the light of that provision. The referring court thus sets out the relationship that it establishes between the provisions of Directive 2006/123 and the national legislation at issue in the main proceedings and the reasons which prompted it to inquire about the interpretation of that directive.

47      Furthermore, the Court has held, on several occasions, that, in accordance with a literal, historical, contextual and teleological interpretation of Directive 2006/123, the provisions of Chapter III thereof, on freedom of establishment of providers, which includes Article 15 of that directive, must be interpreted as meaning that they apply, inter alia, to a situation where all the relevant elements are confined to a single Member State (judgment of 20 April 2023, *Autorità Garante della Concorrenza e del Mercato (Municipality of Ginosa)*, C‑348/22, EU:C:2023:301, paragraph 40 and the case-law cited).

48      Where it is not obvious that the interpretation of a provision of EU law bears no relation to the facts of the main action or its purpose, the objection alleging the inapplicability of that provision to the case in the main action cannot rebut the presumption that the questions referred are relevant and must be examined in the context of the analysis of the questions raised as regards the substance (see, to that effect, judgment of 7 March 2024, *Roheline Kogukond and Others*, C‑234/22, EU:C:2024:211, paragraph 27 and 29 and the case-law cited).

49      It follows that the request for a preliminary ruling is admissible, in so far as it concerns the interpretation of Directive 2006/123.

**Consideration of the questions referred**

50      By its two questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 15 of Directive 2006/123 must be interpreted as precluding national legislation which makes the grant of authorisation for points of sale for tobacco products subject to compliance with conditions relating to the minimum geographical distance between suppliers and to population size, without the possibility of the competent public authority taking into account, in place of those conditions, periodic increases in the number of consumers.

***Scope of Directive 2006/123***

51      It is necessary, first of all, to determine whether Directive 2006/123 must be interpreted as meaning that the situation at issue in the main proceedings falls within its scope; the Spanish and Italian Governments have expressed the view that that directive is inapplicable having regard, respectively, to Article 1(3) and Article 2(1) and (2) of that directive.

52      According to the settled case-law of the Court, it is necessary to interpret the provisions of Directive 2006/123 taking into consideration not only the wording of those provisions but also the context in which they occur and the objectives pursued by the rules of which they form part (see, to that effect, judgments of 15 July 2021, *BEMH and CNCC*, C‑325/20, EU:C:2021:611, paragraph 18, and of 12 October 2023, *INTER Consulting*, C‑726/21, EU:C:2023:764, paragraph 43 and the case-law cited).

53      Pursuant to Article 1(3) of Directive 2006/123, that directive does not deal with the abolition of monopolies providing services.

54      In accordance with recital 8 of Directive 2006/123, the provisions of that directive concerning the freedom of establishment and the free movement of services should apply only to the extent that the activities in question are open to competition, so that they do not oblige Member States, inter alia, to abolish existing monopolies for other activities or certain distribution services.

55      It is thus apparent from the wording of Article 1(3) of Directive 2006/123, read in conjunction with recital 8 thereof, that situations in which the provision of a service is exempt from competition because national legislation has conferred a monopoly on an operator for the provision of certain services are excluded from the scope of that directive (see, to that effect, judgment of 14 November 2018, *Memoria and Dall’Antonia*, C‑342/17, EU:C:2018:906, paragraph 41), and where the application of the provisions of that directive would have the effect of calling into question the existence of that monopoly.

56      Such an interpretation of Article 1(3) of Directive 2006/123 makes it possible to safeguard the effectiveness of the derogation thus established, while respecting the objective of that directive which, as is apparent from Article 1(1) thereof, read in conjunction in particular with recitals 2 and 5, is to remove restrictions on the freedom of establishment for service providers in the Member States and on the free movement of services between the Member States, in order to contribute to the completion of a free and competitive internal market (judgment of 30 January 2018, *X and Visser*, C‑360/15 and C‑31/16, EU:C:2018:44, paragraph 104 and the case-law cited).

57      In the present case, it is apparent from the request for a preliminary ruling that the legislation at issue in the main proceedings reserves the retail sale of manufactured tobacco products to distributors who have been authorised by the public authorities by means of ordinary and special points of sale or by licence.

58      It follows that the activity of retail trade of manufactured tobacco products, which falls within the concept of ‘service’ within the meaning of Article 4(1) of Directive 2006/123 (see, by analogy, judgments of 30 January 2018, *X and Visser*, C‑360/15 and C‑31/16, EU:C:2018:44, paragraph 91, and of 26 September 2018, *Van Gennip and Others*, C‑137/17, EU:C:2018:771, paragraph 76), is not exempt from competition or conferred on a single operator, but is exercised by independent individuals. In addition, the legislation at issue in the main proceedings deals with various operators’ access to the retail distribution market for manufactured tobacco products.

59      As the Advocate General observes in point 47 of his Opinion, although the grant of concessions to operate points of sale, and of licences, entails the exercise of public powers by the Italian authorities authorising points of sale and granting licences, that situation does not mean, however, that those authorities themselves conduct the retail sale of manufactured tobacco products, nor that they interfere in the commercial decisions of the operators of such points of sale and licenced operators.

60      Consequently, legislation which allows only distributors who have been authorised by the public authorities by means of ordinary and special points of sale or by licence to sell manufactured tobacco products, in a retail context, cannot be regarded as falling within the concept of ‘monopolies providing services’ within the meaning of Article 1(3) of Directive 2006/123.

61      As regards the Italian Government’s arguments that Directive 2006/123 is not applicable on the basis of Article 2(1) and (2) thereof, read in conjunction with recital 8 of that directive, since distributors of manufactured tobacco products carry out an economic activity of general interest, ensuring the operation of the revenue-producing monopoly on the sale of tobacco, it is sufficient to note that the Court has already held that the rules laid down by that directive are applicable, in principle, to services of general economic interest, only non-economic services of general interest being excluded from the scope of those rules (judgment of 11 April 2019, *Repsol Butano and DISA Gas*, C‑473/17 and C‑546/17, EU:C:2019:308, paragraph 43).

62      Article 1(3) and Article 2(1) and (2) of Directive 2006/123 must therefore be interpreted as meaning that legislation which reserves the retail sale of manufactured tobacco products to distributors authorised by the public authorities by means of ordinary and special points of sale or by licence falls within the scope of that directive.

***The relevant provisions of Directive 2006/123***

63      According to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, 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 find it necessary to consider provisions of EU law to which the national court has not referred in its questions (judgment of 22 February 2024, *Direcţia pentru Evidenţa Persoanelor şi Administrarea Bazelor de Date*, C‑491/21, EU:C:2024:143, paragraph 23 and the case-law cited).

64      Article 15 of Directive 2006/123, the interpretation of which is sought by the referring court, is set out, together with Article 14, in Section 2 of Chapter III of that directive which concerns requirements that are prohibited or subject to evaluation, whereas Section 1 of that same chapter, which contains Articles 9 to 13 of that directive, concerns authorisations.

65      In that regard, Article 4(6) of Directive 2006/123 defines the concept of an ‘authorisation scheme’ as ‘any procedure under which a provider or recipient is in effect required to take steps in order to obtain from a competent authority a formal decision, or an implied decision, concerning access to a service activity or the exercise thereof’.

66      Article 4(7) of that directive defines the concept of ‘requirement’ as ‘any obligation, prohibition, condition or limit provided for in the laws, regulations or administrative provisions of the Member States or in consequence of case-law, administrative practice, the rules of professional bodies, or the collective rules of professional associations or other professional organisations, adopted in the exercise of their legal autonomy’.

67      The Court has held that an ‘authorisation scheme’ within the meaning of Article 4(6) of Directive 2006/123 is thus distinct from a ‘requirement’ within the meaning of Article 4(7) of that directive, inasmuch as it involves steps being taken by the service provider and a formal decision whereby the competent authorities authorise that service provider’s activity (judgment of 22 September 2020, *Cali Apartments*, C‑724/18 and C‑727/18, EU:C:2020:743, paragraph 49 and the case-law cited).

68      It is apparent from the request for a preliminary ruling that the dispute in the main proceedings concerns the lawfulness of the ADM’s refusal to authorise, in the six-month plan for the establishment of new ordinary points of sale in Liguria, a new point of sale in FA.RO’s establishment, on the ground that the conditions relating to distance and population size laid down by the national legislation were not satisfied.

69      It is also apparent from that request for a preliminary ruling that, in accordance with the national legislation at issue in the main proceedings, in order to be able to market manufactured tobacco products, a service provider must obtain, by way of concession or management arrangement, an ordinary or special point of sale, or a licence, which are awarded following a procedure laid down in that legislation. As regards, in particular, ordinary points of sale, their establishment requires the adoption of a decision by the ADM, in accordance with a six-month plan drawn up in advance. When preparing that plan, the ADM takes account of requests made for the establishment of new points of sale. That plan includes new points of sale for which there is a need for a service and which satisfy the conditions laid down by the relevant legislation.

70      As the Advocate General observed, in essence, in points 59 to 63 of his Opinion, in order to be able to market manufactured tobacco products, a service provider is therefore obliged to take steps, before a competent authority, in order to obtain a formal decision enabling the service provider to gain access to that activity.

71      Such characteristics correspond to those of the ‘authorisation scheme’ within the meaning of Article 4(6) of Directive 2006/123, as referred to in paragraph 67 above. The organisation of the retail sale of manufactured tobacco products is therefore, subject to the verification by the referring court, covered by the concept of ‘authorisation scheme’ within the meaning of that provision.

72      Regarding legislation of a Member State pursuant to which the national legislature makes certain authorities responsible for implementing an authorisation scheme within the meaning of Article 4(6) of Directive 2006/123 by setting the conditions under which the authorisations provided for by that scheme are to be granted, it is for the national courts, first, to assess whether the use by the national legislature of such a mechanism is in line with Article 9 of that directive and, second, to verify whether the criteria set out by that legislature regulating the grant of those authorisations and the effective implementation of those criteria by the local authorities whose measures are contested are in line with the requirements laid down in Article 10 of that directive (see, to that effect, judgment of 22 September 2020, *Cali Apartments*, C‑724/18 and C‑727/18, EU:C:2020:743, paragraph 59).

73      In its request for a preliminary ruling, the referring court clearly stated that it did not intend to call into question, on the basis of Article 9 of Directive 2006/123, the legality of the authorisation scheme laid down in the Italian legislation, thereby excluding from the scope of its questions the compatibility of the national legislature’s use of such a mechanism with that article.

74      Consequently, Article 10 of Directive 2006/123 must be interpreted in such a way as to provide the referring court with all relevant information to enable it to assess whether the conditions relating to distance and population size, to which the national legislation makes the establishment of new ordinary points of sale for manufactured tobacco products subject, comply with that provision.

***The conditions relating to distance and population size***

75      The conditions relating to distance and population size, at issue in the main proceedings, are set out, first, in Article 24(42)(b) of Decree-Law No 98/2011 and, second, in Article 2 of Ministerial Decree No 38/2013. According to the first of those provisions, the distance between ordinary points of sale may not be less than 200 m and a ratio of one point of sale for 1 500 inhabitants must be observed. Pursuant to the second of those provisions, the minimum distance of the premises intended for the new point of sale, in relation to the nearest point of sale already in operation, must be 300 m or more in municipalities with a population not exceeding 30 000 inhabitants, 250 m or more in municipalities with a population of between 30 001 and 100 000 inhabitants, and 200 m or more in municipalities with a population of more than 100 000 inhabitants. That second provision also states that the ratio of one point of sale for 1 500 inhabitants is not to be observed in municipalities with fewer than 1 500 inhabitants without a point of sale, where a real and specific interest of the service can be established and the nearest ordinary point of sale already operating in another municipality is over 600 m away.

76      Article 10(1) of Directive 2006/123 provides that the authorisation schemes referred to in Article 9(1) of that directive must be based on criteria which preclude the competent authorities from exercising their power of assessment in an arbitrary manner. Under Article 10(2)(a) to (g) of that directive, those criteria must be non-discriminatory, justified by an overriding reason relating to the public interest, proportionate to that public interest objective, clear and unambiguous, objective, made public in advance and, lastly, transparent and accessible.

77      As regards, in the first place, the non-discriminatory nature of such criteria, required by Article 10(2)(a) of Directive 2006/123, it should be noted that conditions based on a minimum distance between service providers and on population size do not introduce a distinction based on the nationality of the provider.

78      In the second place, it is important to ascertain whether those conditions relating to distance and population size are justified by an overriding reason relating to the public interest, as required by Article 10(2)(b) of that Directive.

79      It is apparent from the explanations provided by the referring court and the Italian Government that the conditions relating to distance and population size at issue in the main proceedings were adopted with the objective of the protection of human health against the risks generated by manufactured tobacco products.

80      In that regard, it is apparent from Article 24(42)(a) of Decree-Law No 98/2011 that the purpose of laying down criteria intended to regulate the location of the points of sale of manufactured tobacco products is to balance, while also protecting competition, the requirement to ensure that users have a sales network which is well distributed across the territory, on the one hand, and the fundamental public interest in protecting health, on the other hand, consisting in preventing and controlling any supply of tobacco to the public which is not justified by the actual demand for manufactured tobacco products. Article 3(2)(a) and (b) of Ministerial Decree No 38/2013 also provides that the sales network for manufactured tobacco must be adapted to the interest of the service and organised in such a way as to ensure the efficiency and effectiveness of the authorities’ checks for the protection of minors, public policy and public security, public health and revenue.

81      The protection of public health, as is clear from Article 4(8) of Directive 2006/123 and recital 7 thereof, is one of the overriding reasons relating to the public interest that may justify restrictions on the freedoms of movement (see, to that effect, judgment of 23 December 2015, *Hiebler*, C‑293/14, EU:C:2015:843, paragraph 58 and the case-law cited).

82      Therefore, it must be held that the protection of human health against the risks generated by manufactured tobacco products may justify restrictions on the opening of new retail outlets for those products.

83      By contrast, in accordance with the Court’s settled case-law, considerations of a purely economic nature cannot constitute an overriding reason relating to the public interest (see, to that effect, judgments of 15 April 2010, *CIBA*, C‑96/08, EU:C:2010:185, paragraph 48, and of 19 September 2017, *Commission* v *Ireland (Registration tax)*, C‑552/15, EU:C:2017:698, paragraph 89 and the case-law cited).

84      As the Advocate General observed in point 67 of his Opinion, that settled case-law is reflected in Article 14(5) of Directive 2006/123 and recital 66 thereof. In accordance with Article 14(5) of that directive, first, it is prohibited to apply, on a case-by-case basis, an economic test making the granting of authorisation subject to proof of the existence of an economic need or market demand, an assessment of the potential or current economic effects of the activity or an assessment of the appropriateness of the activity in relation to the economic planning objectives set by the competent authority. Second, that prohibition does not concern planning requirements which do not pursue economic aims but serve overriding reasons relating to the public interest.

85      While Article 14(5) of Directive 2006/123 appears in Section 2 of Chapter III of that directive, relating to requirements prohibited or subject to evaluation, whereas Article 10 is in Section 1 of that same Chapter III, dealing with authorisations, an authorisation scheme cannot include prohibited requirements, such as those listed in that first provision, as the Advocate General observed, in essence, in point 64 of his Opinion.

86      Moreover, such a finding follows from the very wording of Article 14(5) of Directive 2006/123, which prohibits making ‘the granting of authorisation’ subject to proof of the existence of an economic need or market demand.

87      In so far as Article 21(1) of Law No 1293/1957 and Article 3(2)(a) and (b) of Ministerial Decree No 38/2013 invoke the need to adapt the sales network to the interest of the service and to guarantee revenue, it is for the referring court to determine whether or not the criteria established by that national legislation lead to the application, on a case-by-case basis, of an economic test which makes the establishment of a new ordinary point of sale subject to proof of the existence of an economic need or market demand within the meaning of Article 14(5) of Directive 2006/123.

88      In that regard, as is apparent from the Italian Government’s observations, the conditions relating to distance and the resident population are intended to limit supply to the actual demand, by avoiding, on the one hand, the proliferation of points of sale in places where demand is already satisfied by existing points of sale and, on the other hand, an insufficient number of points of sale, which could have the effect of leaving part of the demand unsatisfied and, consequently, of encouraging the emergence of smuggling.

89      Since the criteria established by the national legislation at issue in the main proceedings thus seem to aim at a certain balance between supply and demand, those criteria might be classified – which it is for the referring court to ascertain – as an economic test prohibited under Article 14(5) of Directive 2006/123, if it is established that their objective is to ensure a sufficient income for sellers of manufactured tobacco products or to maximise the collection of tax levies on consumers of those products.

90      By contrast, where those criteria did not pursue an objective of an economic nature and were objectively justified by an overriding reason relating to the public interest, such as the protection of public health, by avoiding increased supply encouraging consumption and by having a dissuasive effect on demand, they would not be covered by that prohibition.

91      In the third place, it must be borne in mind that observance of the principle of proportionality, referred to in Article 10(2)(c) of Directive 2006/123, means that a measure is suitable for securing, in a consistent and systematic manner, the attainment of the objective pursued and must not go beyond what is necessary in order to attain it (see, to that effect, judgment of 7 September 2022, *Cilevičs and Others*, C‑391/20, EU:C:2022:638, paragraph 65 and the case-law cited).

92      In order to determine whether and to what extent the legislation at issue in the main proceedings satisfies those requirements, the referring court will need to examine objectively, with the help of statistical data or by other means, whether it may reasonably be concluded from the evidence submitted by the authorities of the Member State concerned that the means chosen are appropriate for the attainment of the objectives pursued and whether it would be possible to attain those objectives by less restrictive measures (see, to that effect, judgment of 21 December 2023, *CDIL*, C‑96/22, EU:C:2023:1025, paragraph 43 and the case-law cited).

93      However, the Court of Justice, which is called on to provide answers of use to the referring court, may provide guidance based on the documents relating to the main proceedings and on the written observations which have been submitted to it, in order to enable the court in question to give judgment (judgment of 21 December 2023, *CDIL*, C‑96/22, EU:C:2023:1025, paragraph 44 and the case-law cited).

94      In that regard, it must be held, as the Advocate General observed in point 90 of his Opinion, that the combination of conditions relating to distance and population size appears to be appropriate both to guarantee supply of manufactured tobacco products throughout the territory and to prevent the uncontrolled increase in supply which thus results in a higher tobacco consumption.

95      In addition, the controlled supply of legally manufactured tobacco products is likely to help reduce the use of contraband products which are likely to act as an incentive to consumption, due to the lower prices at which they are offered, or to pose additional risks to the health of consumers, where they do not meet the standards applicable to tobacco products manufactured or placed on the market in the Member States, in particular as regards the ingredients and emissions of those products.

96      However, in order to achieve, in a consistent and systematic manner, the public health protection objective relied on, the mechanism at issue in the main proceedings should not have the sole effect of guaranteeing the accessibility and availability of manufactured tobacco products, without having a dissuasive effect on the demand for those products. Furthermore, the effectiveness of the application of the conditions relating to distance and population size should not be called into question by other measures.

97      In that regard, it is for the referring court to assess, in the light of the requirements set out in paragraph 92 above, whether the condition relating to the minimum distance between points of sale, as laid down by the national legislation, combined with the condition relating to population size, taking into account the geographical and demographic features of the Member State concerned, is sufficient to discourage the consumption of manufactured tobacco products, without leading to an increase in the unlawful supply of those products.

98      It is also for the referring court to assess whether the increase in the number of vending machines does not call into question the effectiveness of those conditions and the consistent and systematic nature, within the meaning of the case-law cited in paragraph 91 above, of the national legislation at issue in the main proceedings.

99      In that regard, it should be noted that the Italian Government submitted at the hearing before the Court that the installation of vending machines is subject to the same conditions relating to distance and population size as the establishment of points of sale, and they may be installed only by operators holding a concession for an ordinary point of sale or a licence. An operator can install no more than one vending machine, inside or outside its establishment, and operators that may obtain licences may choose to install a cigarette vending machine, after administrative authorisation, as an alternative to that licence.

100    It is for the referring court to ascertain whether, as thus regulated, the installation of vending machines constitutes a means of selling manufactured tobacco products as an alternative to sale by means of ordinary or special points of sale or by licence, which must comply with the same conditions relating to distance and population size, and does not lead to an increase in the supply of those products.

101    As regards the assessment of whether the measure at issue in the main proceedings is necessary, which involves examining the proportionality criterion referred to in Article 10(2)(c) of Directive 2006/123, it should be observed, first, that public health ranks foremost among the assets or interests protected by the FEU Treaty, and that it is for the Member States to determine the degree of protection which they wish to afford to public health and the way in which that degree of protection is to be achieved, which means that they have a measure of discretion in that regard (judgment of 21 December 2023, *CDIL*, C‑96/22, EU:C:2023:1025, paragraph 46 and the case-law cited).

102    Next, it is necessary to take into account the proven harmfulness of the consumption of manufactured tobacco products, by the addictive effects of those products and by the incidence of serious diseases caused by the compounds those products contain that are pharmacologically active, toxic, mutagenic and carcinogenic (see, to that effect, judgment of 4 May 2016, *Philip Morris Brands and Others*, C‑547/14, EU:C:2016:325, paragraph 156).

103    Lastly, it is not indispensable for the restrictive measure issued by the authorities of a Member State to correspond to a conception shared by all Member States as regards the precise way in which the fundamental right or legitimate interest in question is to be protected. On the contrary, the need for, and proportionality of, the provisions adopted are not excluded merely because one Member State has chosen a system of protection different from that adopted in another State (judgment of 7 September 2022, *Cilevičs and Others*, C‑391/20, EU:C:2022:638, paragraph 82 and the case-law cited).

104    In that regard, in view of the discretion referred to in paragraph 101 above, the fact that the FCTC does not envisage, among the measures intended to reduce tobacco consumption, a scheme making the authorisation of new points of sale subject to conditions relating to distance and population size, does not support the conclusion that the scheme at issue in the main proceedings goes beyond what is necessary to achieve that objective.

105    In the light of that discretion, where a Member State considers it useful to introduce measures to control the supply of manufactured tobacco products, that Member State may legitimately take the view that a periodic increase in the number of consumers is not a factor that should be taken into account.

106    Indeed, to take such a periodic increase into account would run counter to the intended objective of limiting supply in order to dissuade consumption.

107    Furthermore, the Italian Government submits that, in compliance with the conditions relating to distance and population size that it sets, the authorisation scheme at issue in the main proceedings provides for particular attention to be paid, in accordance with Article 3(1) and (2) of Ministerial Decree No 38/2013, to areas where there are new residential and commercial developments, to the specific importance of road junctions and the main urban meeting places of the resident population, and to the presence of offices and production structures that are particularly important and well-used. It is for the referring court to ascertain whether that is actually the case.

108    In the fourth place, as regards the requirements referred to in Article 10(2)(d) to (g) of Directive 2006/123, it must be borne in mind, first, that the requirements of clarity and unambiguity (point (d)), refer to the need to make the conditions for authorisation easily understandable by all while avoiding any ambiguity in their wording. Next, the requirement of objectivity (point (e)) is intended to ensure that requests for authorisation are assessed on the basis of their own merits, in order to provide the parties concerned with a guarantee that their request will be dealt with objectively and impartially. Lastly, the requirements of publicity (point (f)) and transparency and accessibility (point (g)), presuppose that any interested person may be informed immediately of the existence of legislation likely to affect access to, or the exercise of, the activity concerned (see, to that effect, judgment of 22 September 2020, *Cali Apartments*, C‑724/18 and C‑727/18, EU:C:2020:743, paragraphs 96 and 107 and the case-law cited).

109    It appears, subject to verification by the referring court, that the conditions relating to distance and population size are based on objective data, are known in advance and are not, in principle, likely to give rise to difficulties of interpretation or application. Since they must be satisfied for the authorisation of any new point of sale, those conditions appear to comply with the requirements referred to in the preceding paragraph of the present judgment.

110    That said, it is apparent from the documents before the Court and from the observations submitted at the hearing that the fact that the conditions relating to distance and population size are satisfied does not, however, guarantee that an authorisation for a new ordinary point of sale will be granted.

111    As is apparent from Article 21(1) of Law No 1293/1957, ordinary points of sale are to be established at the place and time that the authorities consider ‘useful and appropriate in the interest of the service’. Similarly, Article 3(2)(a) of Ministerial Decree No 38/2013 provides that the adoption of six-month plans for the establishment of ordinary points of sale must take into account the need for the sales network of manufactured tobacco products to be ‘adapted to the interest of the service’.

112    That general condition concerning the ‘interest of the service’, the meaning of which is illustrated in Article 3(1) of Ministerial Decree No 38/2013 by way of non-exhaustive examples of some of the factors, in addition to the conditions relating to distance and the resident population which the authorities must take into account, is likely to call into question the clear, unambiguous, objective and transparent nature of the criteria governing the exercise of the authorities’ discretion, which it is for the referring court to verify.

113    In the light of the foregoing, the answer to the questions referred is that Article 10(1) and (2) of Directive 2006/123 must be interpreted as not precluding national legislation which makes the grant of authorisation for points of sale for tobacco products subject to compliance with conditions relating to the minimum geographical distance between suppliers and to population size, without the possibility of the competent public authority taking into account, in place of those conditions, periodic increases in the number of consumers, provided that those conditions:

–        are objectively justified by an overriding reason relating to the public interest, such as the protection of public health against the risks generated by manufactured tobacco products;

–        are likely to have a dissuasive effect on the demand for manufactured tobacco products;

–        apply also to the installation of cigarette vending machines, and

–        applied, where appropriate, with the criterion of the interest of the service, comply with the principle of proportionality and satisfy the requirements of clarity, non-ambiguity, objectivity, publicity, transparency and accessibility.

**Costs**

114    Since 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.

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

**Article 10(1) and (2) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market**

**must be interpreted as not precluding national legislation which makes the grant of authorisation for points of sale for tobacco products subject to compliance with conditions relating to the minimum geographical distance between suppliers and to population size, without the possibility of the competent public authority taking into account, in place of those conditions, periodic increases in the number of consumers, provided that those conditions:**

–        **are objectively justified by an overriding reason relating to the public interest, such as the protection of public health against the risks generated by manufactured tobacco products;**

–        **are likely to have a dissuasive effect on the demand for manufactured tobacco products;**

–        **apply also to the installation of cigarette vending machines, and**

–        **applied, where appropriate, with the criterion of the interest of the service, comply with the principle of proportionality and satisfy the requirements of clarity, non-ambiguity, objectivity, publicity, transparency and accessibility.**

[Signatures]

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[\*](#Footref*)      Language of the case: Italian.

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