OPINION OF ADVOCATE GENERAL LENZ delivered on 4 April 1995

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 II The pharmacists' monopoly as a measure having equivalent effect I - 1629 III Justification of the measure I - 1631 1. Imperative requirements relating to consumer protection 1-1631 2. Protection of health and life of humans I - 1633 (a) Infant formula as a medicinal product I - 1633 (b) Low birth rate and infant mortality I - 1637 3. Comparable arrangements in other Member States I - 1640 C Conclusion I - 1641 * Original language: German. I -1623

OPINION OF MR LENZ CASE C-391/92 A Introduction 2. The origin of the infringement proceedings is a complaint brought by the Greek Association of Infant Formulae Undertakings 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 procedure, the Commission brought an action before the Court in November 1992. 1. In the infringement proceedings with which this Opinion is concerned, the Commission claims that the Court should declare that the Hellenic Republic has failed to fulfil its obligations under Article 30 of the EEC Treaty ' by providing in Article 10 of Ministerial Decree No A 2/oik. 361 of 29 January 1988 that processed milk for infants may be sold only in pharmacists' shops. The contested provision constitutes a pharmacists' sales monopoly for formulae for infants up to the age of five months. Only one exception to the sales monopoly is provided for, for municipalities possessing no pharmacists' shop. 2 In such locations, infant formulae may also be sold otherwise than in pharmacists' shops on certain conditions. 3 3. In its application, the Commission maintains that the provision constitutes a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 30 in accordance with the 'Dassonville test'. 4 Admittedly, there are no Community provisions relating to trade channels for infant formulae and hence in principle competence lies with the Member States. However, that competence may be exercised only in accordance with the provisions of the Treaty. The fact that trade is channelled as a result of the sales monopoly constitutes a measure having equivalent effect within the meaning of the judgments in Destre 5 and Monteil and Samanni, 6 which cannot be justified. 1 The EC 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 populated islands in which medicinal products are normally sold by doctors or State regional distribution centres are involved. 3 Provision of a special counter within the shop complying with public health stipulations. 4. The Greek Government maintains for its part that the provision does not constitute a 4 Judgment in Case 8/74 Dassonville [1974] ECR 837, paragraph 5. 5 Judgment in Case C-369/88 Delattre [1991] ECR 1-1487, paragraph 51. 6 Judgment in Case C-60/89 Monteil and Samanni [1991] ECR 1-1547, paragraph 38. I - 1624

measure having equivalent effect. After the introduction of the measure, consumption of infant formulae remained constant year-onyear, which suggests that it had no restrictive effect. Moreover, the Greek Government argues that in any event the measure was justified. It relies in that connection on protection of public health. It refers in the first place to the particular climatic conditions in Greece. In addition, the low birth rate and relative high infant mortality in Greece necessitate drastic measures. 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 exclusively by pharmacists' shops. In addition, it is sought to promote breast feeding for the good of babies' health. The majority of each year's approximately 110 000 newborn babies are wholly or partly botde-fed. That 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 even illiteracy of a large proportion of Greek women of childbearing age. 7 Accordingly, it is necessary to ensure that advice is available when the product is sold and only a pharmacist, on account of his special expert knowledge, can provide this. 6. The Greek Government further maintains that, in the event of the product's becoming spoiled or being recalled by the manufacturer, only pharmacists are capable of reacting quickly and efficiently on account of the infrastructure available to them. In addition, pharmacists' professional obligations, breach of which is subject to sanctions, afford a guarantee that the requisite care will be taken in storing and selling infant formulae. 7. In addition, Greece did not constitute an exception in adopting the provision in question. Other Member States also had comparable systems for the sale of infant formulae. 8. Since the written procedure ended prior to delivery of the judgment in Keck and 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 rate was 1.9%, but that 49% of the women in question had at best only attended primary school. 8 Judgment of 24 November 1993 in Joined Cases C-267/91 and C-268/91 Keck and Mithouard [1993] ECR 1-6097. I - 1625

B effect within the meaning of Article 30, the parties were given the opportunity to express their views in writing on this case-law and its possible consequences for this case. 10. An important preliminary issue in deciding this case relates to the applicability of Article 30, which in any event appears to warrant consideration following the judgment in Keck and Mithouard. Since the judgment in Dassonville the Court has defined measures having equivalent effect to quantitative restrictions on imports in the following terms: 9. In that regard, the Commission maintained its view that the case involved a measure having equivalent effect within the meaning of Article 30, a view which it supported by argument at the hearing. For its part, the Greek Government argued that the provision at issue constituted selling arrangements within the meaning of the judgments in Keck and Mithouard 9 and Hiinermund 10 and therefore for that reason alone did not fall within the scope of Article 30. 'all trading rules... which are capable of hindering, directly or indirectly, actually or potentially, intra-community trade'. " Since the Cassis de Dijon judgment 12 it has been clear that provisions which are applicable to domestic and foreign products without distinction also constitute measures having equivalent effect within the meaning of Article 30. B Opinion I. Applicability of Article 30 of the Treaty 11. Accordingly in principle both State provisions relating to products u and those relating to marketing,4 fall within the scope of Article 30. In the case of provisions relating to marketing, a development can be per- 9 Cited in footnote 8. 10 Judgment of 15 December 1993 in Case C-292/92 Hiinermund [1993] ECR 1-6787. 11 Judgment cited in footnote 4, paragraph 5. 12 Judgment in Case 120/78 Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein [1979] ECR 649. 13 Cf. the judgments in Case 120/78 Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein, cited in footnote 12, in Case 178/84 Commission v Deutschland [1987] ECR 1227, in Case 216/84 Commission v France [1988] ECR 793, in Case 90/86 Zoni [1988] ECR 4285 and in Case 76/86 Commission v Germany [1989] ECR 1021. 14 Judgments in Case 75/81 Blesgen [1982] ECR 1211, in Case 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 [1991] ECR 1-4151, in Case C-271/92 Laboratoire de prothèses oculaires [1993] ECR 1-2899 and in Case C-315/92 Clinique Laboratoires [1994] ECR 1-317. I - 1626

ceived since the 1980s which has the effect in the result of taking some State measures outside the prohibition set out in Article 30 in 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 meaning of Article 36, 15 at others it held that the measures in question did not even come within the scope of Article 30. I6 restriction. ' 9 However, the Court held as follows in paragraphs 16 and 17 of the judgment: 12. Starting with the judgment in Keck and Mithouard 17 which has since been confirmed on several occasions 18 the Court appears to have settled on a restrictive approach to national marketing rules which are applicable without distinction. In the judgment, the Court does not speak of restricting its earlier case-law, but simply of 'clarifying' it. It also retains the form of words uncurtailed, according to which any measure which is capable of directly or indirectly, actually or potentially, hindering intra-community trade constitutes a measure having equivalent effect to a quantitative 15 See Aragonesa de Publiádad Exterior and Laboratoire de prothèses oculaires, both cited in footnote 14. 16 See the judgments in Blesgen and in Oosthoek's Uitgeversmaatschappij, both cited in footnote 14, in Case C-23/89 Quietlynn and Richards [1990] ECR 1-3059, in Case C-350/89 Sheptonhurst [1991] ECR 1-2387, in Case C-145/88 Torfaen Borough Council v B&Q [1989] ECR 3851, in Case C-332/89 Marchandise [1991] ECR 1-1027 and in Case C-169/91 B&QII [1992] ECR 1-6635. 17 Cited in footnote 8. 18 Judgments in Hiinermund, cited in footnote 10, in Joined Cases C-401/92 and C-402/92 Tankstation t'heukske [1994] ECR 1-2199, in Case C-69/93 Punto Casa [1994] ECR 1-2355 and in Case C-412/93 Leclerc-Siplec [1995] ECR 1-179. '16. However, contrary to what has previously been decided, the application to products from other Member States of national provisions restricting or prohibiting certain selling arrangements is not such as to hinder directly or indirectly, actually or potentially, trade between Member States within the meaning of the Dassonville judgment..., provided that those provisions apply to all affected traders operating within the national territory and provided that they affect in the same manner, in law and in fact, the marketing of domestic products and of those from other Member States. 17. Where those conditions are fulfilled, the application of such rules to the sale of products from another Member State meeting the requirements laid down by that State is not by nature such as to prevent their access to the market or to impede access any more than it impedes the access of domestic products....' 20 19 Cf. paragraphs 11 and 16 of the judgment. 20 My emphasis. I - 1627

OPINION OF MR LENZ CASE C-391/92 13. The innovation therefore relates to certain selling arrangements subject to the conditions referred to. What limiting criteria are to be applied in a specific case are not completely clear from the judgment itself. Consequently, both in the literature and in Opinions of Advocate General Van Gerven 21 and Advocate General Jacobs 22 views have been expressed as to any possible limitations. 23 scope of the provision on sales, it is possible for there to be restrictions which specifically affect imports. To exclude them a priori from the scope of Article 30 seems to me to be inappropriate and also certainly not to have been intended by the judgment in Keck and Mithouard 25 on the face of paragraph 17. 14. A preliminary consideration is appropriate in order to resolve the specific case before the Court: it must be assumed that Article 30 goes beyond a mere prohibition of discrimination. Otherwise, all sorts of national measures would be conceivable which albeit applicable without distinction might be likely to impede the access to the market of products from other Member States. The aim of Article 30 continues to be to prohibit such measures in order to establish and maintain an internal market. 16. What is decisive, therefore, is how 'certain' selling arrangements within the meaning of that judgment can be defined or what sales conditions are not covered thereby and to which the classical test for measures having equivalent effect to quantitative restrictions apply. To my mind, when choosing from among the conceivable approaches that solution should be selected which is most readily to be harmonized with the requirements of the free movement of goods and the former case-law. 15. Preventing or, in any event, impeding access to the market is also conceivable through the imposition of particular sales conditions. 24 Depending on the type and 21 Opinion of Advocate General Van Gerven of 16 March 1994 in Joined Cases C-401/92 and C-402/92 Tankstation 't Heukske, cited in footnote 18, at 1-2201. 22 Opinion of Advocate General Jacobs of 24 November 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 Hiinermund, cited in footnote 10. 24 Cf. Delattre, cited in footnote 5, Monteil and Samanni, cited in footnote 6, and Clinique Laboratoires, cited in footnote 14. 17. Among the attempts to effect a theoretical grasp of the judgment in Keck and Mithouard, it has been argued that the case-law might be construed as the introduction of a de minimis rule. 26 Others interpret the case- 25 Cited in footnote 8. 26 Cf. the Opinion of Advocate General Jacobs in Leclerc- Siplec, cited in footnote 18, section 45. I - 1628

law as a rule relating to the burden of proof. 27 18. Apan from the fact that in its earlier case-law the Court rejected the introduction of a requirement for the measures in question to have an appreciable effect 2S and there is no support for a rule on the burden of proof in that case-law either, 29 a concrete way of considering the particular measure at issue is afforded by those two approaches jointly and by the judgment in Keck and Mithouard. What should be determinative is the hindrance to the access to the market of imported goods. selling arrangement, but it is capable of guiding and channelling sales. 30 This compulsorily excludes other sales channels, which is certainly capable of adversely affecting imports. Since the use in certain circumstances of proven distribution systems 31 is forbidden, this makes product marketing more onerous and more expensive, 32 which has a direct effect on imports. The development of new manners of marketing may in these circumstances prove more difficult for foreign manufacturers than for domestic ones, who are familiar with conditions on the home market. Rules governing the marketing of a product or a group of products generally are more intensive in their effects than rules governing general conditions of sale. 33 II The pharmacists' monopoly as a measure having equivalent effect 19. The introduction of the pharmacists' sales monopoly for infant formulae should be subjected to a 'preliminary examination' against this background. Admittedly, a sales monopoly effectuated by a State measure is a 27 Cf. the Opinion of Advocate General Van Gerven in Tankstation 'i Heukske, cited in footnote 18, footnote 53. 28 Judgments in Case 16/83 Prantl [1984] ECR 1299, paragraph 20, and in Case C-126/91 Yves Rocher [1993] ECR 1-2361, paragraph 21. 29 As a result of the broad definition of measures having equivalent effect, there is no need for proof of the restrictive effect of a measure; conversely, it could not avail a Member State to argue and possibly to prove that the measure in question does not in fact impede imports of goods. 20. Whether import volumes for a class of product differ in absolute terms before and after the introduction of such a measure cannot be decisive in determining whether the measure is to be classed as a measure having equivalent effect, since actual import volumes are also apt to be influenced by substantially different factors, which in turn are affected by the characteristics of the product. In addition, failure of imports to increase, as 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. 32 The parties agree that pharmacists' profit margin is up to 15% whilst, according to a submission made by the Commission at the hearing, that of supermarkets is up to 7%. 33 As, for instance, in the Sunday trading and Sunday employment cases: judgments in Torfaen Borough Council v B&Q, in Marchandise and in B&QÎ1, all cited in footnote 16, and in Case C-306/88 Rochdale Borough Council [1992] ECR 1-6457, in Case 312/89 Conforama [1991] ECR 1-997 and in Case C-304/90 Reading Borough Council [1992] ECR 1-6493. I -1629

OPINION OF MR LENZ CASE C-391/92 would otherwise have been possible, would also constitute a restriction. 21. In my view, the actual introduction of the sales monopoly is in itself capable of impeding imports and hence it should be assumed that Article 30 is applicable. The establishment of monopolies at the marketing level seems, even according to the Court's estimation after the judgment in Keck and Mithouard, to be a measure having equivalent effect within the meaning of Article 30. In the judgments in Ligur Carni 34 and La Crespelle, 35 which were concerned with exclusive rights of certain bodies at the marketing stage, 36 the Court considered Articles 30 and 36 without having recourse solely to the Keck and Mithouard case-law. 22. According to the Court's case-law both before and after the judgment in Keck and Mithouard, a pharmacists' monopoly must therefore be categorized as a measure having equivalent effect. 23. Furthermore, in the instant case there are particular circumstances which alone suggest that the arrangement in question constitutes a measuring having equivalent effect to a quantitative restriction on imports. In Greece no domestic production of infant formulae takes place. The Commission asserted this claim and it was confirmed by the Greek Government in response to a question. There are apparently fourteen competing products on the market, coming from other Member States of the Community. Consequently, it is not possible to make a genuine comparison of the restriction of access to the market for domestic and imported products. Accordingly, any increased difficulty resulting from the measure at issue as regards marketing possibilities specifically affects imported products. 24. Whilst in the judgment in Keck and Mithouard there is a criterion for excluding 'certain' selling arrangements from the scope of Article 30 which is worded as follows, 'provided that [the sales arrangements] affect in the same manner, in law and in fact, the marketing of domestic products and of those from other Member States', the converse conclusion can be inferred in this case that since in fact only the marketing of products from other Member States is affected, the measure must be categorized as a measure having equivalent effect. 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. 36 In Ligur Carni the proceedings were concerned with national legislation under which products (fresh meat) were subjected in transit and on arrival in the municipality of destination to systematic veterinary and health inspections for which a fee had to be paid. The La Crespelle case was concerned with exclusive rights of insemination centres to operate in a particular area. 25. For those reasons, there is, to my mind, no doubt that the monopoly arrangement should be assessed as being a measure having equivalent effect within the meaning of Article 30 of the Treaty. I - 1630

III Justification of the measure 26. The Greek Government puts forward a series of arguments designed to justify the measure, which have to be tested in the classical manner. argues that labelling alone provides insufficient consumer information about infant formulae, that is to say, both from the point of view of the composition of the product and its preparation for use. 27. In the first place, there is the fact that there is a piece of Community legislation concerned with infant formulae and it relates only to their composition, presentation and 37 3S labelling, namely Directive 91/321/EEC. As far as marketing channels are concerned, there is no Community legislation, with the result that the Member States continue to be competent to legislate in this field and to rely, where appropriate, on Article 36 of the Treaty. 29. The composition of infant formulae is bindingly governed at Community level by Directive 91/321. The extent to which ingredients must be mentioned and the manner in which this must take place under the prescribed labelling requirements is governed by Directive 91/321 in conjunction with Directive 79/112/EEC. 4 The compulsory labelling accordingly provides information about product composition. 1. Imperative requirements reding to consumer protection 28. In order to justify the selling arrangement, the Greek Government relies on consumer protection, which is to be taken into account as an imperative requirement. 39 It 37 Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, OJ 1991 L 175, p. 35. 38 Article 1 of the directive refers to the International Code of Marketing of Breast-Milk Substitutes, whose aims and principles dealing with marketing, information and responsibilities of health authorities are to be given effect by the Member States. 39 Cf. the Cassis de Dijon judgment, cited in footnote 12, paragraph 8. 30. The Greek Government argues that the low level of education of a large proportion of women of childbearing age precludes reference to the labelling. Manifestly, the Greek Government is assuming that a substantial number of the women in question are not capable of reading the words on the package. Following the dispute between the Greek Government and the Commission as to how many such women are illiterate, it will be assumed that a small proportion amounting to about 2% of the women potentially affected are illiterate. The question now is whether that circumstance constitutes a 40 Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer, OJ 1979 L 33, p. 1, as amended by Council Directive 89/395/EEC of 14 June 1989, OJ 1989 L 186, p. 17. I-1631

OPINION OF MR LENZ CASE C-391/92 danger which requires and justifies a special selling arrangement. may, however, have graphic representations... for illustrating methods of preparation', a possibility which is made use of in practice. 31. It may be assumed that there are no dangers inherent in the product itself, since infant formulae may in any case be marketed in the Community only if they comply with the provisions of Directive 91/321. 41 It is therefore not absolutely necessary to read 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 pharmacist. 32. As regards the preparation of infant formulae 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 use, nothing more shall be required, as the case may be, than the addition of water'. However, heed should be paid to the quantity of the product to be used and the fact that the water should have been boiled. Symbols and drawings may be employed in order to put over the information necessary to that effect. The second sentence of Article 7(5) of the directive states that '[Infant formulae] 33. I therefore consider that, even if it must be assumed that there is a small percentage of women who cannot read or write, recourse by such persons to infant formulae which are freely obtainable on sale does not constitute a particular danger. 34. Furthermore, it appears to me to be far from reality to assume that a mother of all people should administer something imprudently 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. 35. In Community law, consumer protection is largely taken into account by provisions on labelling. Both the Community legislator and the Court of Justice regard this as an adequate safeguard. In the instant case, there are in my view no discernible grounds for deviating from that rule. 41 The second sentence of Article 2 of the directive provides as follows: 'No product other than infant formula mav be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life'. 36. Consequendy, consumer protection as an imperative requirement does not justify the restrictive selling arrangement. I - 1632

2. Protection of health and life of humans 37. The Greek Government puts forward several grounds, all of which may be subsumed under the general heading of health protection. 'Protection of health' is one of the justificatory grounds set out in Article 36, which the Member States may invoke at any time in areas not governed by Community law. The arguments raised by the Greek Government must therefore be considered, not in the context of the imperative requirements evolved by the Court, but under the heading of one of the public interest grounds set out in Article 36, which may be operative also in the event that a measure restricts imports. 42 39. With regard to the alleged requirement for a doctor's prescription, the Commission vigorously contested that this could be inferred from the Greek legislation. In answer to an express question put at the hearing, the representative of the Greek Government essentially stated that, since the products are subject to monopoly sale by pharmacists, there is inevitably a requirement for a prescription. I am not convinced by that answer. In the final analysis, there is no need to decide in these proceedings on the alleged requirement for a prescription; nevertheless, this circumstance is relevant as regards the Greek Government's classification of the product. (a) Infant formula as a medianal product 38. The Greek Government takes the view that infant formula has the characteristics of a medicinal product and that accordingly the sale of infant formulae has been required to be on doctor's prescription and only from pharmacists. 42 Cf. Aragonesa de Publicidad Extenor, cited in footnote 14, paragraph 13. 40. In this connection, the Greek Government also stated that infant formula is subject 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 might constitute a measure having equivalent effect contrary to Article 30, since it amounts to a product-related restriction of market access and, as a result of Directive 91/321, the composition and presentation of infant 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 these proceedings. I - 1633

OPINION OF MR LENZ CASE C-391/92 41. In contrast, the Greek Government's claim that infant formula has the characteristics of a medicinal product requires further examination. If the product were lawfully categorized as a medicinal product, the legislative decision to restrict its sale to pharmacies would in principle be justified, until such time as proof was given to the contrary. 43 2. Medicinal products Any substance or combination of substances presented for treating or preventing disease in human beings or animals; 42. The expression 'medicinal product' is defined at Community level by Directive 65/65/EEC. 44 Article 1 of that directive provides as follows: Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological f unctions in human beings or in animals is likewise considered a medicinal product'. 45 'For the purposes of this Directive, the following shall have the meanings hereby assigned to them: 43 Cf. the judgments in Defattre, cited in footnote 5, paragraph 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 provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34). According to the first recital in the preamble to that directive, the creation of a monopoly for pharmacists continues to be a matter for the Member States alone. 44 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11). The Court has been called upon on many occasions to interpret this definition. 46 It has repeatedly been a question of the demarcation 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 characteristics it may be subsumed under the Community definition of cosmetics, may nevertheless be regarded as a medicinal product. 47 Comparable case-law exists with regard to the demarcation between medicinal products 45 My emphasis. 46 Judgments in Case C-227/82 Van Bennekom [1983] ECR 3883, in Case 35/85 Thsier [1986] 1207; cf. judgments in Delattre, cited in footnote 5, and in Monteil and Samanni, cited in footnote 6; judgments in Case C-l12/89 Upjohn [1991] ECR 1-1703, in Case C-290/90 Commission v Germany [1992] ECR 1-3317 and in Case C-219/91 Ter Voort [1992] ECR 1-5485. 47 See the judgments in Delattre, cited in footnote 5, in Monteil and Samanni, cited in footnote 6, in Upjohn, cited in footnote 46, and in Case 295/90 Parliament v Council [1992] ECR 1-4193. I - 1634

and foodstuffs. 48 According to that case-law the Member States have a relatively wide discretion to categorize particular products as medicinal products. process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability. 43. Nevertheless, in my view, the defendant Member State is precluded in this case in the light of Community legislation from classing infant formulae as medicinal products. Directive 91/321 on infant formulae and follow-on formulae, which I have repeatedly cited, is based on Directive 89/398/EEC, 49 a directive approximating national legislation on foodstuffs intended for particular nutritional uses. (b) A particular nutritional use must fulfil the particular nutritional requirements: (i)... Article 1 of that directive reads as follows: (") '1. This Directive concerns foodstuffs particular nutritional uses. for (iii) of infants or young children in good health.' 5 2. (a) Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing 48 Cf. the judgments in DeUttre, cited in paragraph 5, and in 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. Point 1 of Annex I to the directive, entitled 'Groups of foods for particular nutritional uses for which specific provisions will be laid down by specific Directives', reads 'Infant formulae'. I - 1635

OPINION OF MR LENZ CASE C-391/92 44. The first recital in the preamble to Directive 91/321 reads as follows: Greek legislator itself assumed that arrangements were being adopted for the sale of foodstuffs for healthy infants. 'Whereas the essential composition of the products in question must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data.' 51 Article 1(1) provides as follows: 45. Moreover, since the focus is expressly on healthy infants, the characteristics required 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 presentation. 53 Restoring, correcting or modifying 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 'This Directive is a specific Directive within the meaning of Article 4 of Directive 89/398/EEC and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in the Community'. 52 I consider that, in view of this binding definition laid down by Community law, a Member State is left with no leeway to subject the foodstuff in question to the special rules for medicinal products. Moreover, in Article 1 of the ministerial decree at issue the 51 My emphasis. 52 My emphasis. 46. Whilst, as a result, infant formulae are not to be categorized as medicinal products, it still has to be considered whether protection of public health warrants the contested arrangements and whether that aim cannot be achieved by means less restrictive of intra- Community trade. 55 53 Cf. medicinal products by virtue of their presentation within the meaning of the first alternative set out in Article 1(2) of Directive 65/65. 54 Cf. Medicinal products by virtue of their characteristics pursuant to the second alternative set out in Article 1(2) of 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 footnote 5), paragraph 67, in Monteil and Samanni (cited in footnote 6), paragraph 46, and in Case C-373/92 Commission v Belgium [1993] ECR 1-3017, paragraphs 8 and 10. I - 1636

(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 adoption of the directive on infant formulae and follow-on formulae in accordance with Article 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. 48. The situation is different with regard to infant mortality. Admittedly, the Commission has sought to undermine the Greek Government's premise that infant mortality is high in Greece by Community standards by referring to statistics for other Member States. I take the view that matters do not turn in this case on whether the rate of infant mortality in Greece is in the first, second or third rank in comparison with other Member States. Combating infant mortality is an aim of public interest in its own right and justifies the taking of appropriate measures to reduce it. The only question is how the pharmacists' monopoly is capable of affecting infant mortality. The Greek Government does not contend that infant formulae present dangers for the life of infants on account of their composition. Indeed, it would be precluded from invoking such dangers on account of the Community rules governing the composition and presentation 49. The Greek Government also submitted with regard to infant mortality that it sought to promote breast feeding. The promotion and protection of breast feeding is a recognized aim of the Community, as Directive 91/321 makes clear. Both the preamble and the operative part of the directive contain several references to that aim. This drive is based on the current state of medical science, according to which breast feeding is superior in some respects with regard to babies' health to bottle-feeding, a view which is being propagated by the World Health Organization. For instance, new born babies do not yet possess an immune system of their own and derive their resources in that respect from their mother's milk, as a result of which statistically breast-fed infants are less prone to illness. In contrast, the pur- 56 It appears from the twelfth recital in the preamble to Directive 91/321 that the Scientific Committee for Food was in fact consulted. As regards the duty to consult scientific committees, see, inter alia, the judgment in Case C-212/91 Angelopbarm [1994] ECR 1-171. I-1637

OPINION OF MR LENZ CASE C-391/92 ported advantages of breast feeding for the child's physical and mental development are less quantifiable. The aim of promoting breast feeding in the interests of infants' health appears therefore to be in the interests of public health. 50. Assuming that breast feeding is beneficial to infants' health, it is necessary to clarify whether the measure at issue is appropriate in order to promote this aim. The promotional effect could be at most an indirect one in so far as it makes bottle-feed more difficult to purchase. When questioned at the hearing, the representative of the 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 essential 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 to breast feed and of the extent to which the baby can be breast fed. 51. Other factors are of a social kind, such as the burden on the woman and the mother in her societal context as a result of her family and career obligations. In my estimation, such factors play quite a significant part in a mother's decision whether to breast feed and whether to continue to breast feed for the time being. This is probably the context in which to situate the submission of the Greek Government, which complains of a reduction of breast feeding on account of socioeconomic factors. Objectively, it is more or less impossible for a working woman who 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 Greek Government also seems to have seen matters in this light when it laid down the derogation from the pharmacists' monopoly by which in municipalities without a pharmacy infant formulae may also be sold in retail shops, which are to set up a special counter and are subject to certain public health provisions. 52. The question therefore arises as to whether restricting the sale of infant formulae to pharmacies is appropriate to achieve the desired side effect of promoting breast feeding. This is more than doubtful. The Greek Government stated at the hearing that breast feeding has been declining in Greece in recent years. It said that this is attributable to the social and economic conditions prevailing at the present time. Increasing numbers of women in Greece are working and hence have less time to occupy themselves with their children, especially in their early months. I - 1638

53. In order to influence breast feeding positively in such a context, it is necessary to create the contextual conditions which will provide even a working woman with the freedom to decide to breast feed her child. 55. The view that monopolizing sales at pharmacies is not capable of promoting breast feeding is also supported by the Greek Government's statement that consumption of infant formula has remained constant, even following the introduction of the pharmacists' monopoly in 1988. However, if the pharmacists' monopoly is incapable of having a positive influence on a mother's decision whether or not to breast feed, it cannot produce a reduction in infant mortality and there is no justification for the restriction of the free movement of goods. 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 conditions is a matter of policy. To my mind, to restrict the sale of infant formulae to pharmacies 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 feed will manage to procure the food essential for her child's survival no matter how hard it is made for her. Consequently, from the purchaser's point of view, the pharmacists' monopoly can only make buying more difficult and products more expensive. 57 Although breast and bottle are alternative methods for feeding infants, they are not substitutes in the sense that where infant formula is more difficult to obtain, this results in more widespread recourse to the natural method of feeding. In principle, a mother's decision as to how to feed her child is determined by other factors, including the socioeconomic ones to which I have already referred. 56. In the course of arguing that the measure was in the public interest, the Greek Government referred to the possibility of the product's spoiling and to the ensuing dangers to infants' health. In this connection, it should be observed that in theory there is always a possibility of foodstuffs' becoming spoilt. In order to minimize this danger, there is a duty imposed by Community law to indicate the date of minimum durability on the product. 58 It requires no special knowledge to be expected of a pharmacist to check whether the sell-by date has been exceeded. A minimum of attention can be expected to be paid to checking the sell-by date also in every retail shop or supermarket. Apart from this, it is to be expected that the mother will take heed of the sell-by date, 57 Whilst, from the manufacturers' and importers' viewpoint, it is liable to make selling the product more difficult and more expensive. 58 See Article 3(1)(4) of Directive 79/112. I-1639

OPINION OF MR LENZ CASE C-391/92 since after all she is buying food for her child. To my mind, checking the sell-by date is sufficient to counter the sale of spoiled infant formula and guarantees this as far as is humanly possible. 57. Moreover, it may be assumed that infant formula is particularly carefully prepared and packaged, as a result inter alia of Directive 91/321. The Greek Government's argument seems to be based to some extent on the false premise that the pharmacist can check the content of each packet of infant formula which he sells. As a rule, infant formula consists of powder which is sold in sealed packages. The pharmacist would have to open the packet in order to carry out analyses of any kind whatsoever on the contents. I therefore take the view that the pharmacists' monopoly affords no greater security against the consumption of spoiled products than allowing the product to be sold in retail shops. 59. In my view, it can be assumed that a product recall will be necessary only in rare exceptional cases. For instance, the Greek Government was incapable of naming a single instance in which such an action had taken place in Greece, but had to refer to an instance in which a product had to be recalled on the Belgian and Luxembourg markets. 59 I consider that by using the possibilities afforded by modern telecommunications in such extremely rare instances a recall action could also be carried out reliably in the event that infant formula was also allowed to be sold otherwise than by pharmacists. The sales channels can be traced and the necessary information communicated. Even if such a recall action should prove more expensive than one conducted using the pharmacists' infrastructure, it would in any event be a more moderate means than establishing a pharmacists' monopoly. 3. Comparable arrangements in other Member States 58. Lastly, the Greek Government argues that in the event of products' being recalled only pharmacists afford a guarantee that such an action will be carried out swiftly and surely. Only they, it is maintained, possess an infrastructure capable of guaranteeing a rapid, reliable and widespread reaction. 60. Lastly, the Greek Government asserts that administrative rules comparable to the Greek pharmacists' monopoly for infant formula exist in other Member States. The Commission denies this and confirms the 59 See the defence, p. 14. I - 1640

existence of statutory selling arrangements only in Spain. Voluntary agreements between manufacturers and distributors are not, in its view, comparable. 61. In principle, the legal view in other Member States gives reason for checking the arguments again for validity. However, no grounds for the statutory arrangements apparently existing in Spain have been adduced which in substantive terms go beyond the justificatory grounds which have already been considered. In so far as arrangements relating to sales channels exist which came into being on the initiative of and pursuant to agreements between the economic agents concerned, they are not caught by Article 30 of the EC Treaty. The Greek Government's reference to practice in other Member States consequently does not involve any factors capable of providing additional justification for its action. In the result, I consider that the pharmacists' monopoly in respect of infant formulae is contrary to Article 30 of the Treaty. Costs According to Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs. C Conclusion 62. In view of the foregoing considerations, I propose that the Court should rule as follows: (1) The Hellenic Republic has failed to fulfil its obligations under Article 30 of the EC Treaty by providing in Article 10 of Ministerial Decree No A 2/oik. 361 of 29 January 1988 that processed milk for infants may be sold only by pharmacies. (2) The Hellenic Republic is ordered to pay the costs. I - 1641