C-391/92

COMMISSION v GREECE

OPINION OF ADVOCATE GENERAL LENZ delivered on 4 April 1995

Summary

A — Introduction I - 1624

B — Opinion I - 1626

I — Applicability of Article 30 of the Treaty I - 1626

3. Comparable arrangements in other Member States I - 1640

C — Conclusion I - 1641

* Original language: German.

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O P I N I O N O F MR L E N Z — CASE C-391/92

A — Introduction ings in April 1988. It maintains that imports would have been more straightforward had Article 10 of the Decree at issue not been adopted. Following the pre-litigation pro- cedure, the Commission brought an action before the Court in November 1992.

2. The origin of the infringement proceed- ings is a complaint brought by the Greek Association of Infant Formulae Undertak- 4. The Greek Government maintains for its part that the provision does not constitute a 1 — The E C Treaty since 1 November 1993 as a result of the Treaty on European Union of 7 February 1992 (OJ 1992 C 224). 2 — According to the Greek Government's submissions, only a small number of municipalities in the mountains or on thinly 4 — Judgment in Case 8/74 Dassonville [1974] ECR 837, para- populated islands in which medicinal products are normally graph 5. sold by doctors or State regional distribution centres are 5 — Judgment in Case C-369/88 Delattre [1991] ECR 1-1487, involved. paragraph 51. 3 — Provision of a special counter within the shop complying 6 — Judgment in Case C-60/89 Monteil and Samanni [1991] with public health stipulations. ECR 1-1547, paragraph 38.

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5. It argues that infant formulae have the characteristics of medicinal products and accordingly it is appropriate that they should be available only on a doctor's prescription. This is the reason why they are sold exclus- ively by pharmacists' shops. In addition, it is sought to promote breast feeding for the 7. In addition, Greece did not constitute an good of babies' health. The majority of each exception in adopting the provision in ques- year's approximately 110 000 newborn tion. Other Member States also had compa- babies are wholly or partly botde-fed. That rable systems for the sale of infant formulae. type of feeding is associated with particular dangers as a result, for instance, of choosing a product which is not the optimum one for meeting the baby's needs or of unsuitable preparation. Labelling is not sufficient to provide information about the composition and proper preparation of infant formulae on account of the poor degree of education — 8. Since the written procedure ended prior even illiteracy — of a large proportion of to delivery of the judgment in Keck and Greek women of childbearing age. 7 Accord- Mithouard, 8 in which the Court altered its case-law on measures having equivalent

7 — In the defence it is stated that the illiteracy rate is 55%. In response to the Commission's submission that the rate is 2.4% at the worst, the Greek Government conceded that the 8 — Judgment of 24 November 1993 in Joined Cases rate was 1.9%, but that 49% of the women in question had C-267/91 and C-268/91 Keck and Mithouard [1993] ECR at best only attended primary school. 1-6097.

11 — Judgment cited in footnote 4, paragraph 5. 10. An important preliminary issue in decid- 12 — Judgment in Case 120/78 Rewe-Zentral AG v Bundesmo- ing this case relates to the applicability of nopolverwaltung für Branntwein [1979] ECR 649. 13 — Cf. the judgments in Case 120/78 Rewe-Zentral AG v Article 30, which in any event appears to Bundesmonopolverwaltung für Branntwein, cited in foot- warrant consideration following the judg- note 12, in Case 178/84 Commission v Deutschland [1987] ECR 1227, in Case 216/84 Commission v France [1988] ment in Keck and Mithouard. Since the judg- ECR 793, in Case 90/86 Zoni [1988] ECR 4285 and in Case 76/86 Commission v Germany [1989] ECR 1021. ment in Dassonville the Court has defined 14 — Judgments in Case 75/81 Blesgen [1982] ECR 1211, in Case measures having equivalent effect to quanti- 286/81 Oosthoek's Uitgeversmaatschappij [1982] ECR 4575, in Case C-362/88 GB-INNO-BM [1990] ECR 1-667, in Case C-369/88 Delattre, cited in footnote 5, in Case C-60/89 Montea and Samanni, cited in footnote 6, in Case C-239/90 Boscher [1991] ECR 1-2023, in Joined Cases C-l/90 and C-176/90 Aragonesa de Publicidad Exterior 9 — Cited in footnote 8. [1991] ECR 1-4151, in Case C-271/92 Laboratoire de pro- 10 — Judgment of 15 December 1993 in Case C-292/92 Hiiner- thèses oculaires [1993] ECR 1-2899 and in Case mund [1993] ECR 1-6787. C-315/92 Clinique Laboratoires [1994] ECR 1-317.

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ceived since the 1980s which has the effect in restriction. ' 9 However, the Court held as the result of taking some State measures out- follows in paragraphs 16 and 17 of the judg- side the prohibition set out in Article 30 in ment: accordance with a balancing exercise which the Court invariably carries out. The path which the Court has taken in order to reach this result has differed. In some cases, it invoked justifying grounds within the mean- ing of Article 36, 1 5 at others it held that the measures in question did not even come within the scope of Article 30. I6

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13. The innovation therefore relates to cer- scope of the provision on sales, it is possible tain selling arrangements subject to the con- for there to be restrictions which specifically ditions referred to. What limiting criteria are affect imports. To exclude them a priori from to be applied in a specific case are not com- the scope of Article 30 seems to me to be pletely clear from the judgment itself. Con- inappropriate and also certainly not to have sequently, both in the literature and in Opin- been intended by the judgment in Keck and ions of Advocate General Van Gerven 21 and Mithouard 25 on the face of paragraph 17. Advocate General Jacobs 22 views have been expressed as to any possible limitations. 23

15. Preventing or, in any event, impeding access to the market is also conceivable through the imposition of particular sales conditions. 2 4 Depending on the type and 17. Among the attempts to effect a theoreti- cal grasp of the judgment in Keck and Mith- 21 — Opinion of Advocate General Van Gerven of 16 March ouard, it has been argued that the case-law 1994 in Joined Cases C-401/92 and C-402/92 Tankstation 't might be construed as the introduction of a Heukske, cited in footnote 18, at 1-2201. 22 — Opinion of Advocate General Jacobs of 24 November de minimis rule. 26 Others interpret the case- 1994 in Leclerc-Siplec, cited in footnote 18. 23 — The ground had previously been prepared by the Opinion of Advocate General Tesauro of 27 October 1993 in Hiiner- mund, cited in footnote 10. 24 — Cf. Delattre, cited in footnote 5, Monteil and Samanni, 25 — Cited in footnote 8. cited in footnote 6, and Clinique Laboratoires, cited in 26 — Cf. the Opinion of Advocate General Jacobs in Leclerc- footnote 14. Siplec, cited in footnote 18, section 45.

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II — The pharmacists' monopoly as a meas- ure having equivalent effect 20. Whether import volumes for a class of product differ in absolute terms before and after the introduction of such a measure can- not be decisive in determining whether the measure is to be classed as a measure having equivalent effect, since actual import vol- umes are also apt to be influenced by sub- 19. The introduction of the pharmacists' stantially different factors, which in turn are sales monopoly for infant formulae should affected by the characteristics of the product. be subjected to a 'preliminary examination' In addition, failure of imports to increase, as against this background. Admittedly, a sales monopoly effectuated by a State measure is a 30 — Cf. to this effect Delattre, cited in footnote 5, and Montea and Samanni, cited in footnote 6. 31 — The measure at issue was not introduced until 1988. 27 — Cf. the Opinion of Advocate General Van Gerven in Tank- 32 — The parties agree that pharmacists' profit margin is up to station 'i Heukske, cited in footnote 18, footnote 53. 15% whilst, according to a submission made by the Com- 28 — Judgments in Case 16/83 Prantl [1984] ECR 1299, para- mission at the hearing, that of supermarkets is up to 7%. graph 20, and in Case C-126/91 Yves Rocher [1993] ECR 33 — As, for instance, in the Sunday trading and Sunday employ- 1-2361, paragraph 21. ment cases: judgments in Torfaen Borough Council v B&Q, 29 — As a result of the broad definition of measures having in Marchandise and in B&QÎ1, all cited in footnote 16, and equivalent effect, there is no need for proof of the restric- in Case C-306/88 Rochdale Borough Council [1992] ECR tive effect of a measure; conversely, it could not avail a 1-6457, in Case 312/89 Conforama [1991] ECR 1-997 and in Member State to argue and possibly to prove that the meas- Case C-304/90 Reading Borough Council [1992] ECR ure in question does not in fact impede imports of goods. 1-6493.

34 — Judgment in Joined Cases C-227/91, C-318/91 and C-319/91 Ligur Carni [1993] ECR 1-6621. 35 — Judgment in Case C-323/93 La Crespelle [1994] ECR 1-5077. 25. For those reasons, there is, to my mind, 36 — In Ligur Carni the proceedings were concerned with national legislation under which products (fresh meat) were no doubt that the monopoly arrangement subjected in transit and on arrival in the municipality of destination to systematic veterinary and health inspections should be assessed as being a measure having for which a fee had to be paid. The La Crespelle case was equivalent effect within the meaning of Arti- concerned with exclusive rights of insemination centres to operate in a particular area. cle 30 of the Treaty.

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III — Justification of the measure argues that labelling alone provides insuffi- cient consumer information about infant for- mulae, that is to say, both from the point of view of the composition of the product and its preparation for use. 26. The Greek Government puts forward a series of arguments designed to justify the measure, which have to be tested in the clas- sical manner.

29. The composition of infant formulae is bindingly governed at Community level b y 27. In the first place, there is the fact that Directive 91/321. The extent to which ingre- there is a piece of Community legislation dients must be mentioned and the manner in concerned with infant formulae and it relates which this must take place under the pre- only to their composition, presentation and scribed labelling requirements is governed by labelling, namely Directive 91/321/EEC. 37 3S Directive 91/321 in conjunction with Direc- As far as marketing channels are concerned, tive 79/112/EEC. 4° The compulsory label- there is no Community legislation, with the ling accordingly provides information about result that the Member States continue to be product composition. competent to legislate in this field and to rely, where appropriate, on Article 36 of the Treaty.

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danger which requires and justifies a special may, however, have graphic representations selling arrangement. ... for illustrating methods of preparation', a possibility which is made use of in practice.

31. It may be assumed that there are no dan- 33. I therefore consider that, even if it must gers inherent in the product itself, since be assumed that there is a small percentage infant formulae may in any case be marketed of women who cannot read or write, in the Community only if they comply with recourse by such persons to infant formulae the provisions of Directive 91/321. 41 It is which are freely obtainable on sale does not therefore not absolutely necessary to read constitute a particular danger. and check the substances making up the product in order to administer it safely. Moreover, a potential purchaser is quite free to seek advice at any time from a person she trusts, namely one of her relations or acquaintances, or consult her doctor or phar- macist. 34. Furthermore, it appears to me to be far from reality to assume that a mother of all people should administer something impru- dently to her child, thus endangering her infant, since it can generally be assumed that it will be the mother who will primarily see to the well-being of her child.

32. As regards the preparation of infant for- mulae for use, in principle the situation can be no otherwise. Article 4(3) of Directive 91/321 provides that 'In order to make infant formulae and follow-on formulae ready for 35. In Community law, consumer protection use, nothing more shall be required, as the is largely taken into account by provisions case may be, than the addition of water'. on labelling. Both the Community legislator However, heed should be paid to the quan- and the Court of Justice regard this as an tity of the product to be used and the fact adequate safeguard. In the instant case, there that the water should have been boiled. Sym- are in my view no discernible grounds for bols and drawings may be employed in order deviating from that rule. to put over the information necessary to that effect. The second sentence of Article 7(5) of the directive states that '[Infant formulae]

(a) Infant formula as a medianal product

40. In this connection, the Greek Govern- ment also stated that infant formula is sub- ject to the licensing procedure for medicinal products. That factual claim was confirmed by the Commission, which inferred the licensing requirement from Article 3 of the ministerial decree at issue. In my view, this 38. The Greek Government takes the view might constitute a measure having equivalent that infant formula has the characteristics of effect contrary to Article 30, since it amounts a medicinal product and that accordingly the to a product-related restriction of market sale of infant formulae has been required to access and, as a result of Directive 91/321, be on doctor's prescription and only from the composition and presentation of infant pharmacists. formulae as requirements for market access are governed exclusively by Community law. However, there is no need to assess the licensing procedure as it is not the subject of 42 — Cf. Aragonesa de Publicidad Extenor, cited in footnote 14, paragraph 13. these proceedings.

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41. In contrast, the Greek Government's 2. Medicinal products claim that infant formula has the characteris- tics of a medicinal product requires further examination. If the product were lawfully categorized as a medicinal product, the legis- lative decision to restrict its sale to pharma- cies would in principle be justified, until Any substance or combination of substances such time as proof was given to the con- presented for treating or preventing disease trary. 43 in human beings or animals;

The Court has been called upon on many 'For the purposes of this Directive, the fol- occasions to interpret this definition. 46 It has lowing shall have the meanings hereby repeatedly been a question of the demarca- assigned to them: tion line between medicinal products and cosmetics against the background of more difficult conditions of market access for medicinal products. The Court has held that a product, even when by virtue of its charac- teristics it may be subsumed under the Com- munity definition of cosmetics, may never- theless be regarded as a medicinal product. 47 Comparable case-law exists with regard to the demarcation between medicinal products 43 — Cf. the judgments in Defattre, cited in footnote 5, para- graph 56, and in Monteil and Samanni, cited in footnote 6, paragraph 43. Cf. also Council Directive 85/432/EEC of 16 December 1985 concerning the coordination of provi- sions laid down by law, regulation or administrative action 45 — My emphasis. in respect of certain activities in the field of pharmacy (OJ 46 — Judgments in Case C-227/82 Van Bennekom [1983] ECR 1985 L 253, p. 34). According to the first recital in the pre- 3883, in Case 35/85 Thsier [1986] 1207; cf. judgments in amble to that directive, the creation of a monopoly for Delattre, cited in footnote 5, and in Monteil and Samanni, pharmacists continues to be a matter for the Member States cited in footnote 6; judgments in Case C-l12/89 Upjohn alone. [1991] ECR 1-1703, in Case C-290/90 Commission v Ger- 44 — Council Directive 65/65/EEC of 26 January 1965 on the many [1992] ECR 1-3317 and in Case C-219/91 Ter Voort approximation of provisions laid down by law, regulation [1992] ECR 1-5485. or administrative action relating to medicinal products (OJ, 47 — See the judgments in Delattre, cited in footnote 5, in Mon- English Special Edition 1965-1966, p. 20), as amended by teil and Samanni, cited in footnote 6, in Upjohn, cited in Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L footnote 46, and in Case 295/90 Parliament v Council 142, p. 11). [1992] ECR 1-4193.

2. (a) Foodstuffs for particular nutritional uses are foodstuffs which, owing to their Point 1 of Annex I to the directive, entitled special composition or manufacturing 'Groups of foods for particular nutritional uses for which specific provisions will be laid down by specific Directives', reads 'Infant 48 — Cf. the judgments in DeUttre, cited in paragraph 5, and in formulae'. Ter Voort, cited in footnote 46. 49 — Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, OJ 1989 L 186, p. 27. 50 — My emphasis.

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44. The first recital in the preamble to Greek legislator itself assumed that arrange- Directive 91/321 reads as follows: ments were being adopted for the sale of foodstuffs for healthy infants.

'Whereas the essential composition of the products in question must satisfy the nutri- tional requirements of infants in good health 45. Moreover, since the focus is expressly on as established by generally accepted scientific healthy infants, the characteristics required data.' 5 1 to comply with the definition of medicinal products set out in Directive 65/65 are not present. Product characteristics going beyond the effects that any healthy nutrition has in warding off human illnesses cannot be attributed to the product by mere presenta- tion. 53 Restoring, correcting or modifying Article 1(1) provides as follows: physiological functions assumes in the first place that those functions deviate from the norm and this cannot be assumed in the case of healthy infants. 54

I consider that, in view of this binding defi- nition laid down by Community law, a 53 — Cf. medicinal products by virtue of their presentation Member State is left with no leeway to sub- within the meaning of the first alternative set out in Article ject the foodstuff in question to the special 1(2) of Directive 65/65. 54 — Cf. Medicinal products by virtue of their characteristics rules for medicinal products. Moreover, in pursuant to the second alternative set out in Article 1(2) of Article 1 of the ministerial decree at issue the Directive 65/65. 55 — Cf. judgments in Case 104/95 De Peijper [1976] ECR 613, paragraph 32, in Case 247/81 Commission v Germany [1984] ECR 1111, paragraph 7, in Case 87/85 Cophalux [1986] ECR 1707, paragraph 19, in Delattre (cited in foot- note 5), paragraph 67, in Monteil and Samanni (cited in 51 — M y emphasis. footnote 6), paragraph 46, and in Case C-373/92 Commis- 52 — M y emphasis. sion v Belgium [1993] E C R 1-3017, paragraphs 8 and 10.

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(b) Low birth rate and infant mortality of bottle feed. In case the foodstuffs intended for particular nutritional uses might affect public health, the Scientific Committee for Food had to be consulted prior to the adop- tion of the directive on infant formulae and follow-on formulae in accordance with Arti- cle 4 of Directive 89/398. 56

47. The Greek Government submits that the low birth rate and relatively high rate of infant mortality necessitated radical steps. As far as the low birth rate is concerned, my view is that selling arrangements are in no way apt to influence the birth rate one way or the other. This finding seems so obvious to me as to require no further argument to back it up.

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ported advantages of breast feeding for the which to situate the submission of the Greek child's physical and mental development are Government, which complains of a reduc- less quantifiable. The aim of promoting tion of breast feeding on account of socio- breast feeding in the interests of infants' economic factors. Objectively, it is more or health appears therefore to be in the interests less impossible for a working woman who of public health. has no time or place to be together with her child — even if she is in favour of breast feeding — exclusively to breast feed him for four to five months as doctors recommend. Against this background, it is imperative that supplies of a substitute product should be available to the population everywhere in the country in the interests of public health. The 50. Assuming that breast feeding is benefi- Greek Government also seems to have seen cial to infants' health, it is necessary to clar- matters in this light when it laid down the ify whether the measure at issue is appropri- derogation from the pharmacists' monopoly ate in order to promote this aim. The by which in municipalities without a phar- promotional effect could be at most an indi- macy infant formulae may also be sold in rect one in so far as it makes bottle-feed retail shops, which are to set up a special more difficult to purchase. When questioned counter and are subject to certain public at the hearing, the representative of the health provisions. Greek Government stated in effect that the promotion of breast feeding was not the main aim of the measure, but a welcome side-effect. Consequently, I consider it essen- tial to consider what factors are liable to influence a woman's decision on how to feed her baby. The prime factors are certainly the physical possibilities of a woman and a mother and the law can have no effect on them. This is true both of the ability t o breast feed and of the extent to which the baby can be breast fed.

54. It is not for the Court to make proposals as to which societal measures are appropriate to persuade mothers where appropriate to breast feed, creating the contextual condi- tions is a matter of policy. To my mind, to restrict the sale of infant formulae to phar- macies is in principle not capable of having a positive influence on mothers' decision whether or not to breast feed. A mother who, for whatsoever reason, cannot breast 56. In the course of arguing that the measure feed will manage to procure the food essen- was in the public interest, the Greek Gov- tial for her child's survival no matter how ernment referred to the possibility of the hard it is made for her. Consequently, from product's spoiling and to the ensuing dan- the purchaser's point of view, the pharma- gers to infants' health. In this connection, it cists' monopoly can only make buying more should be observed that in theory there is difficult and products more expensive. 57 always a possibility of foodstuffs' becoming Although breast and bottle are alternative spoilt. In order to minimize this danger, methods for feeding infants, they are not there is a duty imposed by Community law substitutes in the sense that where infant for- to indicate the date of minimum durability mula is more difficult to obtain, this results on the product. 5 8 It requires no special in more widespread recourse to the natural knowledge to be expected of a pharmacist to method of feeding. In principle, a mother's check whether the sell-by date has been decision as to how to feed her child is deter- exceeded. A minimum of attention can be mined by other factors, including the socio- expected to be paid to checking the sell-by economic ones to which I have already date also in every retail shop or supermarket. referred. Apart from this, it is to be expected that the mother will take heed of the sell-by date,

60. Lastly, the Greek Government asserts 58. Lastly, the Greek Government argues that administrative rules comparable to the that in the event of products' being recalled Greek pharmacists' monopoly for infant for- only pharmacists afford a guarantee that such mula exist in other Member States. The an action will be carried out swiftly and Commission denies this and confirms the surely. Only they, it is maintained, possess an infrastructure capable of guaranteeing a rapid, reliable and widespread reaction. 59 — See the defence, p. 14.

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