**Case C-108/09**

**Ker-Optika bt**

**v**

**ÀNTSZ Dél-dunántúli Regionális Intézete**

(Reference for a preliminary ruling from the Baranya megyei bíróság)

(Free movement of goods – Public health – Selling of contact lenses via the internet – National legislation authorising the sale of contact lenses solely in medical supply shops – Directive 2000/31/EC – Information society – Electronic commerce)

Summary of the Judgment

1.        *Approximation of laws – Electronic commerce – Directive 2000/31*

*(European Parliament and Council Directive 2000/31)*

2.        *Free movement of goods – Quantitative restrictions – Measures having equivalent effect*

*(Art. 34 TFEU and 36 TFEU; European Parliament and Council Directive 2000/31, Art. 3(4))*

1.        National rules relating to the selling of contact lenses fall within the scope of Directive 2000/31 on certain legal aspects
of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’)
since they concern the act of selling such lenses via the Internet, namely, in particular, the on line offer and the conclusion
of the contract by electronic means. On the other hand, the national rules relating to the supply of contact lenses are not
covered by that directive.

(see paras 28, 31, 77, operative part)

2.        Articles 34 TFEU and 36 TFEU, and Directive 2000/31 on certain legal aspects of information society services, in particular
electronic commerce, in the Internal Market (‘Directive on electronic commerce’), must be interpreted as precluding national
legislation which authorises the selling of contact lenses only in shops which specialise in medical devices.

Such legislation constitutes a measure having an effect equivalent to a quantitative restriction, as prohibited by Article
34 TFEU, since the consequent prohibition on the selling of contact lenses via the Internet applies to contact lenses from
other Member States, which are sold by mail order and delivered to the home of customers resident within the national territory,
and deprives traders from other Member States of a particularly effective means of selling those products, thus significantly
impeding the access of those traders to the market of the Member State concerned.

It is true that by reserving the supply of contact lenses to the opticians’ shops which offer the services of a qualified
optician, such legislation is appropriate for securing the attainment of the objective of ensuring protection of the health
of contact lens users. However, in adopting such legislation, the national legislature exceeded the limits of the discretion
which it is allowed to determine the level of protection which it wishes to afford to public health, and that legislation
must be held to go beyond what is necessary to attain the claimed objective, since that objective can be achieved by measures
which are less restrictive than those provided for under that legislation, namely measures which subject to certain restrictions
only the first supply of lenses and which require the economic operators concerned to make available a qualified optician
to the customer.

For the same reasons, since it contains a prohibition on selling contact lenses via the Internet, that legislation cannot
be held to be proportionate to the objective of ensuring the protection of public health, for the purposes of Article 3(4)
of Directive 2000/31.

(see paras 58, 64, 74-76, 78, operative part)

JUDGMENT OF THE COURT (Third Chamber)

2 December 2010 (*)

(Free movement of goods – Public health – Selling of contact lenses via the Internet – National legislation authorising the sale of contact lenses solely in medical supply shops – Directive 2000/31/EC – Information society – Electronic commerce)

In Case C‐108/09,

REFERENCE for a preliminary ruling under Article 234 EC from the Baranya megyei bíróság (Hungary), made by decision of 10
February 2009, received at the Court on 23 March 2009, in the proceedings

**Ker-Optika bt**

v

**ÀNTSZ Dél-dunántúli Regionális Intézete,**

THE COURT (Third Chamber),

composed of K. Lenaerts, President of the Chamber, D. Šváby, R. Silva de Lapuerta, E. Juhász and J. Malenovský (Rapporteur),
Judges,

Advocate General: P. Mengozzi,

Registrar: B. Fülöp, Administrator,

having regard to the written procedure and further to the hearing on 15 April 2010,

after considering the observations submitted on behalf of:

–        the Hungarian Government, by R. Somssich, K. Szíjjártó, K. Veres and M. Fehér, acting as Agents,

–        the Czech Government, by M. Smolek, acting as Agent,

–        the Greek Government, by E. Skandalou, acting as Agent,

–        the Spanish Government, by J.M. Rodríguez Cárcamo, acting as Agent,

–        the Netherlands Government, by C. Wissels, M. de Grave and Y. de Vries, acting as Agents,

–        the European Commission, by H. Krämer and A. Sipos, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 15 June 2010,

gives the following

**Judgment**

1        This reference for a preliminary ruling concerns the interpretation of Directive 2000/31/EC of the European Parliament and
of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce,
in the Internal Market (‘Directive on electronic commerce’) (OJ 2000 L 178, p. 1) and of Articles 34 TFEU and 36 TFEU.

2        The reference has been made in proceedings between Ker-Optika bt (‘Ker-Optika’) and ÀNTSZ Dél-dunántúli Regionális Intézete
(South Transdanubian Regional Directorate of the national public health and medical services; ‘ÀNTSZ’) concerning an administrative
decision whereby ÀNTSZ prohibited Ker-Optika from selling contact lenses via the Internet.

**Legal context**

*European Union (‘EU’) legislation*

3        Under Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure
for the provision of information in the field of technical standards and regulations and of rules on Information Society services
(OJ 1998 L 204, p. 37), as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 (OJ
1998 L 217, p. 18) (‘Directive 98/34’), the following meanings are to apply:

‘“service”, any Information Society service, that is to say, any service normally provided for remuneration, at a distance,
by electronic means and at the individual request of a recipient of services.

For the purposes of this definition:

–        “at a distance” means that the service is provided without the parties being simultaneously present,

–        “by electronic means” means that the service is sent initially and received at its destination by means of electronic equipment
for the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received by
wire, by radio, by optical means or by other electromagnetic means,

–        “at the individual request of a recipient of services” means that the service is provided through the transmission of data
on individual request.

...’

4        Recitals 18, 21 and 34 of the preamble to Directive 2000/31 state:

‘(18) Information society services span a wide range of economic activities which take place on-line; these activities can, in particular,
consist of selling goods on-line; activities such as the delivery of goods as such or the provision of services off-line are
not covered. ... activities which by their very nature cannot be carried out at a distance and by electronic means, such as
the statutory auditing of company accounts or medical advice requiring the physical examination of a patient are not information
society services.

...

(21)      ... the coordinated field covers only requirements relating to on‐line activities such as on-line information, on-line advertising,
on-line shopping, on-line contracting and does not concern Member States’ legal requirements relating to goods such as safety
standards, labelling obligations, or liability for goods, or Member States’ requirements relating to the delivery or the transport
of goods, including the distribution of medicinal products; ...

...

(34)      Each Member State is to amend its legislation containing requirements, and in particular requirements as to form, which are
likely to curb the use of contracts by electronic means; the examination of the legislation requiring such adjustment should
be systematic and should cover all the necessary stages and acts of the contractual process, including the filing of the contract;
the result of this amendment should be to make contracts concluded electronically workable ... ’

5        Under Article 1(1),(2), (3) and (5) of Directive 2000/31:

‘1.      This Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information
society services between the Member States.

2.      This Directive approximates, to the extent necessary for the achievement of the objective set out in paragraph 1, certain
national provisions on information society services relating to the internal market, the establishment of service providers,
commercial communications, electronic contracts, the liability of intermediaries, codes of conduct, out-of-court dispute settlements,
court actions and cooperation between Member States.

3.      This Directive complements Community law applicable to information society services without prejudice to the level of protection
for, in particular, public health and consumer interests, as established by Community acts and national legislation implementing
them in so far as this does not restrict the freedom to provide information society services.

...

5.      This Directive shall not apply to:

(a)      the field of taxation;

(b)      questions relating to information society services covered by Directives 95/46/EC and 97/66/EC;

(c)      questions relating to agreements or practices governed by cartel law;

(d)      the following activities of information society services:

–        the activities of notaries or equivalent professions to the extent that they involve a direct and specific connection with
the exercise of public authority,

–        the representation of a customer and defence of his interests before the courts,

–        gambling activities which involve wagering a stake with monetary value in games of chance, including lotteries and betting
transactions.’

6        Article 2 of Directive 2000/31 is worded as follows:

‘For the purpose of this Directive, the following terms shall bear the following meanings:

(a)      “information society services”; services within the meaning of Article 1(2) of Directive 98/34 ...;

...

(h)      “coordinated field”; requirements laid down in Member States’ legal systems applicable to information society service providers
or information society services, regardless of whether they are of a general nature or specifically designed for them.

(i)      The coordinated field concerns requirements with which the service provider has to comply in respect of:

–        the taking up of the activity of an information society service, such as requirements concerning qualifications, authorisation
or notification,

–        the pursuit of the activity of an information society service, such as requirements concerning the behaviour of the service
provider, requirements regarding the quality or content of the service including those applicable to advertising and contracts,
or requirements concerning the liability of the service provider.

(ii)      The coordinated field does not cover requirements such as:

–        requirements applicable to goods as such,

–        requirements applicable to the delivery of goods,

–        requirements applicable to services not provided by electronic means.’

7        Under Article 3 of Directive 2000/31:

‘1.      Each Member State shall ensure that the information society services provided by a service provider established on its territory
comply with the national provisions applicable in the Member State in question which fall within the coordinated field.

2.      Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society
services from another Member State.

...

4.      Member States may take measures to derogate from paragraph 2 in respect of a given information society service if the following
conditions are fulfilled:

(a)      the measures shall be:

(i)      necessary for one of the following reasons:

–        public policy, in particular the prevention, investigation, detection and prosecution of criminal offences, including the
protection of minors and the fight against any incitement to hatred on grounds of race, sex, religion or nationality, and
violations of human dignity concerning individual persons,

–        the protection of public health,

–        public security, including the safeguarding of national security and defence,

–        the protection of consumers, including investors;

(ii)      taken against a given information society service which prejudices the objectives referred to in point (i) or which presents
a serious and grave risk of prejudice to those objectives;

(iii) proportionate to those objectives;

(b)      before taking the measures in question and without prejudice to court proceedings, including preliminary proceedings and acts
carried out in the framework of a criminal investigation, the Member State has:

–        asked the Member State referred to in paragraph 1 to take measures and the latter did not take such measures, or they were
inadequate,

–        notified the Commission and the Member State referred to in paragraph 1 of its intention to take such measures.

5.      Member States may, in the case of urgency, derogate from the conditions stipulated in paragraph 4(b). Where this is the case,
the measures shall be notified in the shortest possible time to the Commission and to the Member State referred to in paragraph
1, indicating the reasons for which the Member State considers that there is urgency.

...’

8        Article 4(1) of that directive states:

‘Member States shall ensure that the taking up and pursuit of the activity of an information society service provider may
not be made subject to prior authorisation or any other requirement having equivalent effect.’

9        Under Article 9(1) of Directive 2000/31:

‘Member States shall ensure that their legal system allows contracts to be concluded by electronic means. Member States shall
in particular ensure that the legal requirements applicable to the contractual process neither create obstacles for the use
of electronic contracts nor result in such contracts being deprived of legal effectiveness and validity on account of their
having been made by electronic means.’

*National legislation*

10      Under Article 3(1) of Law CVIII of 2001 on electronic commerce and information society services (a elektronikus kereskedelmi
szolgáltatások, valamint az információs társadalommal összefùggő szolgáltatásokról szóló 2001. évi CVIII. Törvény; ‘the Law
on electronic commerce’):

‘No prior authorisation or official decision having equivalent effect shall be required in order to take up or pursue the
activity of an information society services provider.’

11      Under Article 3(1) of Order 7/2004 (XI. 23.) of the Ministry of Health on the technical requirements relating to the sale,
repair and hiring of medical devices (a gyógyászati segédeszközök forgalmazásának, javításának, kölcsönzésének szakmai követelményeiről
szóló 7/2004 (XI. 23.) Egészségügyi Minisztériumi rendelet) (‘the Ministry of Health Order’):

‘Medical devices may be sold, repaired and hired ... in a specialist shop, provided that it has an operating licence under a
separate provision and that it satisfies the conditions laid down in Points I.1 and I.2 of Annex 2 to this order.’

12      Under Annex 1 of that Order:

‘The following medical devices are excluded from the scope of this order:

...

–        mass–produced optical products, with the exception of contact lenses;

...’

13      It is apparent from Point I.1(d) of Annex 2 to that Order that, in order to sell contact lenses and custom‐made spectacles,
a shop with a minimum area of 18 m2 or premises separated from the workshop is required. One of the conditions relating to staff, in point I.2(c) of that Annex,
is the requirement that the services of an optometrist or an ophthalmologist qualified in the field of contact lenses must
be used.

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

14      Ker-Optika sells contact lenses via its Internet site. By a decision of 29 August 2008, ÀNTSZ Pécsi, Sellyei, Siklósi Kistérségi
Intézete (the local ÀNTSZ office for the districts of Pécs, Sellye and Siklós), prohibited that activity.

15      Following a complaint made by Ker-Optika against that decision, ÀNTSZ confirmed that prohibition by a decision of 14 November
2008.

16      ÀNTSZ relied, in particular, on the provisions of the Ministry of Health Order, under which the only ways in which contact
lenses can be sold are either in a shop which specialises in the sale of medical devices or by home delivery for final consumption.
Neither the name nor the content of the latter concept covers selling via the Internet.

17      Ker-Optika brought an action against that decision claiming, in particular, that the sale of contact lenses via the Internet
cannot be subject to restrictions in the light of Article 3(1) of the Law on electronic commerce, which safeguards the right
of an information society service provider to pursue that activity freely.

18      In that regard, ÀNTSZ relied on Recital 18 of Directive 2000/31 which makes it clear that the scope of the Law on electronic
commerce cannot encompass the sale of contact lenses via the Internet. According to Recital 18, activities which, by their
very nature, cannot be carried out at a distance or by electronic means, such as medical advice requiring the physical examination
of a patient, are not information society services. The selling of contact lenses requires such an examination.

19      In those circumstances, the Baranya megyei bíróság decided to stay proceedings and to refer to the Court of Justice the following
questions for a preliminary ruling:

‘1.      Does the sale of contact lenses constitute medical advice requiring the physical examination of a patient and thus not fall
within the scope of Directive [2000/31]?

2.      If the sale of contact lenses does not constitute medical advice requiring the physical examination of a patient, must Article
30 EC be interpreted as precluding legislation of a Member State under which contact lenses may be sold only in shops which
specialise in the supply of medical devices?

3.      Does the principle of the free movement of goods laid down in Article 28 EC preclude the provision of Hungarian law which
authorises the selling of contact lenses solely in shops which specialise in the supply of medical devices?’

**Consideration of the questions referred for a preliminary ruling**

20      By its questions, which should be examined together, the referring court asks, in essence, whether EU law precludes national
legislation, such as that at issue in the main proceedings, which authorises the sale of contact lenses only in shops which
specialise in the sale of medical devices and which prohibits, consequently, the sale of contact lenses via the Internet.

21      To answer the questions raised, the Court must identify the provisions of EU law applicable to the sale of contact lenses
via the Internet and then decide whether those provisions preclude national rules such as those at issue in the main proceedings.

22      First, in relation to Internet sales, the following features can, inter alia, be identified. Such sales comprise, initially,
the act of selling *per se* which consists in the making of a contractual offer on-line and the conclusion of a contract by electronic means. Next, such
sales involve the delivery of the product sold, generally to the customer’s home. Furthermore, in certain individual cases,
the customer obtains medical advice before the sale or the supply takes place.

*Directive 2000/31*

23      As regards, first, the act of selling, it should be recalled, at the outset, that, in accordance with Articles 1(2) and 2(a)
of Directive 2000/31, that directive approximates certain national provisions on information society services, namely services
normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services.

24      As is apparent from Recital 18 of Directive 2000/31, such information society services cover, inter alia, the selling of goods
on-line.

25      That is confirmed by the explanatory memorandum accompanying the proposal for a directive submitted by the Commission on 18
November 1998 (COM(1998) 586 final), which states that information society services include services of selling goods and
services allowing on-line electronic transactions to purchase goods such as interactive tele‐shopping and on-line shopping
malls.

26      Next, it should be observed that, in accordance with Recital 34 and Article 9(1) of Directive 2000/31, each Member State must
systematically adjust any of its legislation which contains requirements likely to curb the use of contracts by electronic
means and which covers all the necessary stages and acts of the contractual process of selling goods on-line, such as the
contractual offer, the negotiation and the conclusion of the contract by electronic means.

27      Lastly, it should be stated that the activity of selling medical devices such as contact lenses is not listed among the activities
to which, under Article 1(5) of Directive 2000/31, that directive is not applicable.

28      Consequently, the coordinated field of Directive 2000/31 covers the national provisions which prohibit acts relating to the
selling of contact lenses, namely, in particular, the on‐line offer and the conclusion of the contract by electronic means.

29      Secondly, as regards supply, it should be observed that, according to the precise wording of Article 2(h)(ii) of Directive
2001/31, the coordinated field does not cover requirements applicable to the supply of goods in respect of which a contract
has been concluded by electronic means.

30      Consequently, the national rules which relate to the conditions under which goods sold via the Internet may be supplied within
the territory of a Member State fall outside the scope of that directive.

31      It follows that the conditions of the supply of contact lenses are not covered by Directive 2000/31.

32      Thirdly, the Court should consider whether the above findings are affected by the fact that the selling or the supply of contact
lenses may be subject to the requirement that the customer first obtain medical advice.

33      In that regard, as stated in Recital 18 of Directive 2000/31, activities which, by their very nature, cannot be carried out
at a distance or by electronic means, such as medical advice requiring the physical examination of a patient, are not information
society services, and consequently, do not fall within the scope of that directive.

34      Accordingly, if medical advice requiring a physical examination of a customer is inseparable from the selling of contact lenses,
the fact that such advice is required means that such selling does not, ultimately, fall within the scope of that directive.

35      On that point, it should be observed that contact lenses come into direct contact with the eyes and constitute medical devices
the use of which may, in individual cases, cause eye inflammations and even lasting visual impairment, medical conditions
which may be caused by the mere wearing of contact lenses. The requirement of prior medical advice can therefore be held to
be justified.

36      In that regard, any person who wishes to wear contact lenses may be obliged to undergo a precautionary ophthalmological examination
in the course of which a check is made that no medical factors preclude that person from wearing lenses and a determination
is made of the exact values, in dioptres, of the correction required.

37      However, that examination is not inseparable from the selling of contact lenses. It can be carried out independently of the
act of sale, and the sale can be effected, even at a distance, on the basis of a prescription made by the ophthalmologist
who has previously examined the customer.

38      Consequently, it must be held that it is possible to separate from the selling of contact lenses the obtaining of medical
advice which requires the physical examination of a patient and on which the sale may be dependent.

39      Moreover, while it is true that health considerations may require that the customer obtain the benefit both of medical advice
for the purposes of physical examinations of the fitting of lenses, and of ophthalmological checks, at regular intervals,
to determine the effect of wearing lenses, those examinations and checks occur when the lenses are being used, in other words,
after the supply of the lenses. Accordingly, such medical advice cannot be linked with the act of selling the lenses.

40      It follows that a national provision which prohibits the selling of such lenses via the Internet falls, in principle, within
the scope of Directive 2000/31.

*Primary law*

41      Given that the rules relating to the conditions of the supply of contact lenses are not covered by Directive 2000/31, those
rules must be assessed under primary law, namely the FEU Treaty.

42      As a preliminary point, the Court must consider whether those rules fall to be examined in relation to the freedom to provide
services, as maintained by the Hungarian Government, or in relation to the free movement of goods, as suggested by the referring
court.

43      In that regard, it is settled case-law that, where a national measure relates to both the free movement of goods and another
fundamental freedom, the Court will in principle examine it in relation to one only of those two fundamental freedoms, if
it appears that one of them is entirely secondary in relation to the other and may be considered together with it (see, to
that effect, Case C‐275/92 *Schindler* [1994] ECR I‐1039, paragraph 22, and Case C‐20/03 *Burmanjer and Others* [2005] ECR I‐4133, paragraph 35).

44      Further, it follows from Case C‐322/01 *Deutscher Apothekerverband* [2003] ECR I‐14887, paragraphs 65, 76 and 124, that a national measure concerning an arrangement characterised by the sale
of goods via the Internet and the delivery of those goods to the customer’s home is to be examined only with regard to the
rules relating to the free movement of goods and, consequently, with regard to Articles 34 TFEU and 36 TFEU.

45      In the present case, the national legislation prohibiting the selling of contact lenses via the Internet concerns a selling
arrangement characterised by the delivery of such lenses to the customer’s home.

46      Consequently, that legislation must be examined with regard to Articles 34 TFEU and 36 TFEU.

Whether there is a restriction on the free movement of goods

47      According to settled case-law, all trading rules enacted by Member States which are capable of hindering, directly or indirectly,
actually or potentially, trade within the European Union are to be considered as measures having an effect equivalent to quantitative
restrictions and are, on that basis, prohibited by Article 34 TFEU (see, inter alia, Case 8/74 *Dassonville* [1974] ECR 837, paragraph 5, and Case C‐110/05 *Commission* v *Italy* [2009] ECR I‐519, paragraph 33).

48      It is also apparent from settled case-law that Article 34 TFEU reflects the obligation to comply with the principles of non-discrimination
and of mutual recognition of products lawfully manufactured and marketed in other Member States, as well as the principle
of ensuring free access of EU products to national markets (see *Commission* v *Italy*, paragraph 34 and the case‐law cited).

49      Accordingly, measures adopted by a Member State the object or effect of which is to treat products coming from other Member
States less favourably are to be regarded as measures having an effect equivalent to quantitative restrictions, as are rules
that lay down requirements to be met by such goods, even if those rules apply to all products alike (see *Commission* v *Italy*, paragraphs 35 and 37).

50      Any other measure which hinders access of products originating in other Member States to the market of a Member State is also
covered by that concept (*Commission* v *Italy*, paragraph 37).

51      For that reason, the application to products from other Member States of national provisions restricting or prohibiting certain
selling arrangements is such as to hinder directly or indirectly, actually or potentially, trade between Member States for
the purposes of the case‐law flowing from *Dassonville*, unless those provisions apply to all relevant traders operating within the national territory and affect in the same manner,
in law and in fact, the selling of domestic products and of those from other Member States. The application of such rules
to the sale of products from another Member State meeting the requirements laid down by that State is by nature such as to
prevent their access to the market or to impede such access more than it impedes the access of domestic products (see, to
that effect, Joined Cases C‐267/91 and C‐268/91 *Keck and Mithouard* [1993] ECR I‐6097, paragraphs 16 and 17, and *Commission* v *Italy*, paragraph 36).

52      Accordingly, it is necessary to examine whether the national legislation at issue in the main proceedings meets the two conditions
stated in the preceding paragraph of this judgment, in other words, whether it applies to all relevant traders operating within
the national territory and whether it affects in the same manner, in law and in fact, the selling of domestic products and
the selling of those from other Member States.

53      As regards the first condition, it is clear that the legislation applies to all relevant traders involved in selling contact
lenses, which means that that condition is satisfied.

54      As regards the second condition, it is undisputed that the prohibition on the selling of contact lenses via the Internet applies
to contact lenses from other Member States which are sold by mail order and delivered to the home of customers resident in
Hungary. It is clear that the prohibition on selling contact lenses by mail order deprives traders from other Member States
of a particularly effective means of selling those products and thus significantly impedes access of those traders to the
market of the Member State concerned (see, by analogy, in relation to medicinal products, *Deutscher Apothekerverband*, paragraph 74).

55      In those circumstances, that legislation does not affect in the same manner the selling of contact lenses by Hungarian traders
and such selling as carried out by traders from other Member States.

56      It follows that that legislation constitutes a measure having an effect equivalent to a quantitative restriction, as prohibited
by Article 34 TFEU, unless that legislation can be objectively justified.

Whether the restriction on the free movement of goods is justified

57      According to settled case-law, an obstacle to the free movement of goods may be justified on one of the public interest grounds
set out in Article 36 TFEU or in order to meet overriding requirements. In either case, the national provision must be appropriate
for securing the attainment of the objective pursued and must not go beyond what is necessary in order to attain it (see,
inter alia, *Commission* v *Italy*, paragraph 59 and the case-law cited).

58      In that regard, if that measure is within the field of public health, account must be taken of the fact that the health and
life of humans rank foremost among the assets and interests protected by the Treaty and that it is for the Member States to
determine the level of protection which they wish to afford to public health and the way in which that level is to be achieved.
Since the level may vary from one Member State to another, Member States should be allowed a measure of discretion (see Joined
Cases C‐570/07 and C‐571/07 *Blanco Pérez and Chao Gómez* [2010] ECR I‐0000, paragraph 44 and the case-law cited).

59      In the present case, the justification relied on by the Hungarian Government concerns the need to ensure protection of the
health of contact lens users. That justification corresponds, therefore, to the public health concerns acknowledged in Article
36 TFEU which may justify an obstacle to the free movement of goods.

60      Accordingly, it is necessary to examine whether the legislation at issue in the main proceedings is appropriate for securing
the attainment of the objective pursued.

61      In that regard, the Hungarian and Spanish Governments maintain that it is necessary to require customers to take delivery
of contact lenses in specialist shops, because they must have access to an optician who can carry out the necessary physical
examinations, undertake checks and give those customers instructions on the wearing of the lenses.

62      On that point, it should be recalled, as was stated in paragraph 35 of this judgment, that the mere wearing of contact lenses
may, in individual cases, cause eye ailments, and even lasting visual impairment.

63      Given the risks to public health which thus exist, a Member State may impose a requirement that contact lenses are to be supplied
by qualified staff who are to alert the customer to those risks, carry out an examination of the customer and recommend or
advise against the wearing of lenses, while inviting the person concerned, where necessary, to obtain the advice of an ophthalmologist.
Because of those risks, a Member State may also impose a requirement that, where the wearing of lenses is not advised against,
qualified staff are to determine the most appropriate type of lenses, check the positioning of the lenses on the eyes and
provide the customer with information on the correct use and care of the lenses (see, to that effect, Case C‐271/92 *LPO* [1993] ECR I‐2899, paragraph 11).

64      While not entirely eliminating the risks incurred by users of lenses, the establishment of a link to a qualified optician
and the services provided by such an optician are likely to reduce those risks. Accordingly, by reserving the supply of contact
lenses to the opticians’ shops which offer the services of such an optician, the legislation at issue in the main proceedings
is appropriate for securing the attainment of the objective of ensuring protection of the health of those users.

65      It is also necessary, however, that that legislation does not go beyond what is necessary in order to attain that objective,
in other words that there are not other measures less restrictive of the free movement of goods by means of which that objective
could be achieved.

66      First, as regards the requirement that the customer must be physically present to have his eyes examined by an optician at
the sales outlet, it must be observed, first, that precautionary examinations, carried out for investigative purposes, can
be undertaken by ophthalmologists in places other than opticians’ shops.

67      Also, there is nothing in the documents submitted to the Court to suggest that it is a requirement of the legislation at issue
in the main proceedings either that an optician must make every supply of lenses dependent on a precautionary examination
or on medical advice having first been obtained or that those conditions are imposed, in particular, on each occasion when
there is a series of supplies of lenses to the same customer.

68      Accordingly, undergoing such examinations and obtaining such advice must be held to be optional, and consequently it is primarily
the responsibility of each contact lens user to make use of them, while the task of the optician in that regard is to give
advice to the users.

69      However, customers can be advised, in the same way, before the supply of contact lenses, as part of the process of selling
the lenses via the Internet, by means of the interactive features on the Internet site concerned, the use of which by the
customer must be mandatory before he can proceed to purchase the lenses (see, to that effect, as regards the selling of medicinal
products via the Internet, *Deutscher Apothekerverband*, paragraph 114).

70      Second, it is true that the Member State can require – as was stated in paragraph 63 of this judgment – that the determination
of which type of contact lenses is the most appropriate should be undertaken by a optician, who is under an obligation, at
that time, to check the positioning of the lenses on the customer’s eyes and to make available to the customer advice on the
correct use and care of the lenses.

71      However, it should be observed that those services are required, as a general rule, only when contact lenses are first supplied.
At the time of subsequent supplies, there is, as a general rule, no need to provide the customer with such services. It is
sufficient that the customer advise the seller of the type of lenses which were provided when lenses were first supplied,
the specifications of those lenses having been adjusted, where necessary, by an ophthalmologist who has issued a new prescription
which takes into account any change in the customer’s vision.

72      Third, while the extended use of contact lenses must be accompanied by supplementary information and advice, those can be
given to the customer by means of the interactive features to be found on the supplier’s Internet site.

73      Moreover, the Member State may require the economic operators concerned to make available to the customer a qualified optician
whose task is to give to the customer, at a distance, individualised information and advice on the use and care of the contact
lenses. The provision of such information and advice at a distance may, moreover, offer advantages, since the lens user is
enabled to submit questions which are well thought out and pertinent, and without the need to go out (see, to that effect,
as regards the selling of medicinal products via the Internet, *Deutscher Apothekerverband,* paragraph 113).

74      It follows from the foregoing that the objective of ensuring protection of the health of users of contact lenses can be achieved
by measures which are less restrictive than those provided for under the legislation at issue in the main proceedings, namely
measures which subject to certain restrictions only the first supply of lenses and which require the economic operators concerned
to make available a qualified optician to the customer.

75      Consequently, where a Member State adopts legislation such as that at issue in the main proceedings, it exceeds the limits
of the discretion referred to in paragraph 58 of this judgment, and that legislation must therefore be held to go beyond what
is necessary to attain the objective the Member State claims to pursue.

76      For the same reasons, since it contains a prohibition on selling contact lenses via the Internet, that legislation cannot
be held to be proportionate to the objective of ensuring the protection of public health, for the purposes of Article 3(4)
of Directive 2000/31.

77      In the light of the foregoing, the answer to the questions submitted by the referring court is that the national rules relating
to the selling of contact lenses fall within the scope of Directive 2000/31 since they concern the act of selling such lenses
via the Internet; on the other hand, the national rules relating to the supply of contact lenses are not covered by that directive.

78      Articles 34 TFEU and 36 TFEU, and Directive 2000/31, must be interpreted as precluding national legislation which authorises
the selling of contact lenses only in shops which specialise in medical devices.

**Costs**

79      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national 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 (Third Chamber) hereby rules:

**The national rules relating to the selling of contact lenses fall within the scope of Directive 2000/31/EC of the European
Parliament and the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic
commerce, in the Internal market (‘Directive on electronic commerce’), since they concern the act of selling such lenses via
the Internet. On the other hand, the national rules relating to the supply of contact lenses are not covered by that directive.**

**Articles 34 TFEU and 36 TFEU, and Directive 2000/31, must be interpreted as precluding national legislation which authorises
the selling of contact lenses only in shops which specialise in medical devices.**

[Signatures]

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- Language of the case: Hungarian.