C-77/97

ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL

OPINION OF ADVOCATE GENERAL COSMAS delivered on 2 July 1998 * Summary

I — Introduction I - 434

II — F a a s I-434

III — The question referred I - 436

IV — Is 'Odol-Med 3 (Samtweiss)' toothpaste a medicinal product or a cosmetic

law I-448

A — The relevant provisions of secondary Community law I - 449

B — The arguments of the parties I - 451

C — My views on the preliminary question I - 453

(a) The harmonisation brought about by Directive 76/768 I - 453

(b) National measures restricting the free movement of cosmetic products from the viewpoint of Directive 76/768 I - 460 VI — Conclusion I - 464

1. In this case the Court has been asked by the Handelsgericht Wien to give a prelimi- nary ruling on a question concerning the interpretation of Article 30 of the E C Treaty and Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic prod- 3. Smithkline claims, and the national court ucts. 1 The proceedings pending before the agrees, that the marketing in Austria of prod- national court concern the marketing in Aus- ucts such as 'Odol-Med 3 (Samtweiss)' tooth- tria of toothpaste which is manufactured and paste is subject to the Law on Foodstuffs marketed without restriction in Germany. ('LMG'), 3Paragraph 5 of which provides that certain products for the care and cleaning of human teeth, e. g. toothpaste, are cosmetic products 'which are subject to certain restric- tions and prohibitions. In particular, Para- graph 26 of the LMG prohibits the marketing II — Facts of cosmetic products which contain pharma- cologically active substances not authorised, not conforming to the conditions of authori- sation or in prohibited quantities, or are wrongly described or contain misleading ref- erences to physiological or pharmacological 2. The parties to the main proceedings are effects. If a toothpaste contains pharmaco- Österreichische Unilever G m b H ('Unilever'), logically active substances it is also subject to the plaintiff, and Smithkline Beecham Marke- the Regulation of the Federal Minister for nartikel GesmbH ('Smithkline'), both of Health and Consumer Protection on the whom market cosmetic products, including authorisation of pharmacologically active toothpaste, in Austria. The defendant sells in substances in cosmetic products ('the Cos- Austria the toothpaste 'Odol-Med 3 (Samt- metics Regulation'). 4 That regulation, which weiss)' which is made in Germany by Lingner was issued on the basis of the power con- & Fischer. According to the order for refer- ferred by Paragraph 27(2) of the LMG, has ence, it is stated on the toothpaste tubes and two annexes. Annex 1 specifies seven groups in television advertising that 'Odol-Med 3 of active substances, including substances with (Samtweiss)' is a preventive against parodon- keratinising effect, substances which inhibit tosis, contains or produces threefold prophy- caries and substances which inhibit plaque. laxis, gives threefold protection against caries, Annex 2 gives an exhaustive list of the phar- plaque and parodontosis and removes plaque macologically active substances which may be or reduces the formation of tartar. 2 Unilever

used in the individual groups of active Cosmetics Regulation, which describes the substances listed in Annex 1, the maximum said substance as inhibiting caries, but it con- quantities of authorised pharmacologically tains none of the substances listed there which active substances, and the warning statements are described as preventing the formation of which must accompany them. In so far as tartar or preventing paradontosis. In Uni- toothpastes are, according to the Cosmetics lever's opinion, the statements concerning the Regulation, cosmetic products which come toothpaste in television advertising and on into contact with the mucous membranes, the packaging, that the product has the effect Annex 2 to the regulation applies to them and consequently they may contain the specified pharmacologically active substances only in the maximum quantities laid down in the

4. According to Unilever, the problem with consumers against damage to health or against deception, taking account of the current sute of scientific knowledge marketing O d o l - M e d 3 (Samtweiss)' in Aus- and technology after obtaining the opinion of the Codex tria arises from the fact that it contains only Commission, lay down by decree that certain substances are to be excluded or restricted in the marketing of cosmetic sodium monofluorophosphate of the per- products and he shall make orders by analogy with Paragraph 10(1), Nos. 1 to 3.

use. Environment shall, where this is compatible with the protec- Paragraph 9(1) of the LMG: tion of consumers against damage to health and against In the marketing of foodstuffs, products for consumption and deception, taking account of the current sute of scientific additives, it shall be prohibited knowledge and technology, on application authorise by decree (a) to refer to the prevention, relief or cure of illnesses or unauthorised substances with pharmacological effects and symptoms of illnesses or to physiological or pharmaco- colouring agents, lay down conditions for their use, prescribe logical effects, particularly any which maintain a youthful the requisite degree of purity and specify the maximum per- appearance, inhibit signs of ageing, promote slimming or mitted quantities in cosmetic products. The decree must be maintain health, or to create the impression of any such subject to a time limit, but the period shall not exceed three effect; years. The decree shall be rescinded if the conditions for (b) to refer to case histories, medical recommendations or authorisation are no longer fulfilled. The application for expert reports; authorisation must be accompanied by all the ¿doumentation (c) to use health-related, pictorial or stylised representations which enables the substance to be assessed. of organs of the human body, pictures of members of the Paragraph 1 of the Cosmetics Regulations: medical or nursing professions or of sanatoria, or other Of the groups of active substances specified in Annex 1, only pictures or illustrations referring to treatment activities. the pharmacologically active substances specified in Annex 2 Paragraph 26 of the LMG: shall be authorised for cosmetic products in accordance with (1) It shall be prohibited to market cosmetic products which Paragraph 5(1) of the LMG 1975. (a) are detrimental to health when used for the intended pur- The groups of active substances specified in Annex 1 are as pose or when used in a way which may be foreseen; follows: (b) contain pharmacologically active substances or colouring 1. Substances with kerarinising effect. agents which are unauthorised, do not conform with the 2. Substances with astringent effect. conditions of authorisation or are in impermissible quanti- 3. Substances which counteract irritation of the gums.

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of inhibiting tartar, removing plaque and pre- would affect trade within the Community. venting or inhibiting paradontosis are mis- Therefore the national court decided to refer leading and therefore incompatible with the the question of the interpretation of Article Cosmetics Regulation and the LMG. 30 of the Treaty and of Directive 76/768 to the Court of Justice for a preliminary ruling, so that a final decision could be given on the compatibility of the national legislation with the abovementioned provisions of Commu- nity law.

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question was referred. The French Govern- product is of crucial importance to the out- ment contends that in Community law it come of the proceedings before the national would be more correct to regard the tooth- court. If 'Odol-Med 3 (Samtweiss)' tooth- paste in question as a medicinal product and paste is a medicinal product within the not a cosmetic product, so that the question meaning of Council Directive 65/65/EEC, as of the free movement of the product in the correctly construed, its marketing is subject internal market in accordance with Article 30 to very stringent requirements. A medicinal of the EC Treaty would have to be deter- product may be placed on the market in a mined by reference to the secondary legisla- Member State only when the competent tion concerning the approximation of national authority of that State has issued an authori- laws relating to medicinal products. In the sation. 6 Authorisation depends on strict French Government's opinion, therefore, formal requirements and is subject to con- Directives 65/65/EEC, 92/27/EEC and stant monitoring by the national administra- 92/28/EEC are applicable, and not Directive tive authorities. In addition, Council Direc- 76/768, to which the national court refers, tive 92/27 lays down detailed rules on labelling and package leaflets for medicinal products for human use. The Community rules on the advertising of such products, laid down by Council Directive 92/28, are also especially strict. There is no doubt that the Community measures on cosmetic products, as set out in Council Directive 76/768, are less onerous for those products than the corresponding requirements for medicinal products.

(2) The products to be considered as cosmetic products within the meaning of this defini- tion are listed in Annex I.' Any substance or combination of substances which may be administered to human beings Annex I is entitled 'Illustrative list by cat- or animals with a view to making a medical egory of cosmetic products'. It includes 'prod- diagnosis or to restoring, correcting or modi- ucts intended for care of the teeth and the fying physiological functions in human beings mouth'. 7 or in animals is likewise considered a medicinal product.'

Article 1 of Council Directive 65/65 8 is worded as follows:

B — Arguments of the parties

'For the purposes of this Directive, the fol- lowing shall have the meaning hereby assigned to them:

12. In their observations, the French Gov- ernment and the Government of the United 1. Proprietary medicinal product Kingdom contend that 'Odol-Med 3 (Samt- weiss)' should be classified as a medicinal product. The French Government refers to Any ready-prepared medicinal product placed the Court's Upjohn judgment of 16 April on the market under a special name and in a 1991, 9 which found that a product with the special pack. characteristics of a medicinal product is sub- ject only to Directive 65/65 and the measures amending it. If the toothpaste in question is advertised as a means of treatment, i. e. as 7 — See Annex I of Directive 76/768. 8 — Directive on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition, 1965-1966, p. 20). 9 — Case C-112/89 [1991] ECR I-1703.

having the effect of inhibiting parodontosis, it 14. In contrast, Smithkline contends that cos- must be regarded as a medicinal product in metic products such as 'Odol-Med 3 (Samt- accordance with the definition in Article 1 (2), weiss)' toothpaste are covered only by Direc- subparagraph 1, of Directive 65/65. Further- tive 76/768. The product in question obviously more, according to the French Government, falls within the scope of that directive so that it is possible that the product in question is there can be no question of another directive, also a medicinal product by virtue of func- e. g. Directive 65/65, being applicable at the tion in accordance with Article 1 (2), subpara- same time. The directive on cosmetic prod- graph 2, if the fluorine concentration exceeds ucts was adopted after the directive on medic- 0.15%.

13. The reply given to the Court's question tion of misleading consumers because they do by the parties to the main proceedings and not regard toothpaste as a medicinal product. the Commission is in the negative. Unilever refers firstly to the national law, which states that toothpastes are cosmetic products, which is why the abovementioned provisions of the LMG and the Cosmetics Regulation prohibit cosmetic products such as toothpastes from carrying statements to the effect that they prevent, relieve or treat symptoms of illness. Unilever concludes that toothpastes (other than pharmaceutical toothpastes, which may be regarded as medicinal products) are not a

product. However, the Commission considers tion 'with a view to making a medical diag- that the toothpaste in question is not a medic- nosis or to restoring, correcting or modifying inal product by virtue of presentation or of physiological functions in human beings'. 10 function. According to the Commission, the abovementioned statements on the packaging of the toothpaste and in the television adver- 10 — Article 1(2), second subparagraph. Directive 65/65. tising do not make it a product which is pre-

18. At first sight there can be no doubt, in my opinion, that in principle a product such as the toothpaste in question falls within the definition of 'cosmetic product' given by C — My views on the question Directive 76/768, i. e. it is a cosmetic product within the meaning of Article 1(1) of the Directive. Toothpastes are in fact preparations which are intended for 'placing in contact with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or 16. The national court has not asked whether correct body odours'. That is also the main the product in question must be classified under Community secondary legislation as a medicinal product or a cosmetic product. 12 — See the judgments in Case C-241/89 SARPP [1990] ECR However, it must be borne in mind that 'the I-4695, paragraph 8, and Case C-315/92 Verband Sozialer Wettbewerb [1994] ECR I-317, paragraph 7. Court, which is competent under Article 177 13 — That is to say, Directives 76/768 (cited in paragraph 1 above), of the Treaty to provide courts of the Member 65/65 (cited in footnote 8), Council Directive 92/28/EEC of 31 March 1992 (OJ 1992 L 113, p. 13), Council Directive 92/27/EEC of 31 March 1992 (OJ 1992 L 113, p. 8), Council Directive 84/450 of 10 September 1984 (OJ 1984 L 250 p, 17) and Directive 89/552/EECof 3 October 1989 (OJ 1989 L 298, p. 23), which was amended by Directive 97/36/EC 11 — See the Upjohn judgment cited in footnote 9, paragraph 22. of the Parliament and the Council (OJ 1997 L 202, p. 60).

14 — The Court has on several previous occasions considered the problem of choosing the most appropriate measures in Community law for classifying preparations which are in the borderline area between medicinal products and other types of product. See, for example, the following judgments: Consequently, even though it may fall within Case 227/82 Van Bennekom [1983] ECR 3883, concerning health foods, vitamins and mineral products; the definition in Article 1(1) of Directive Case C-369/88 Delattre [1991] ECR I-1487, concerning 76/768, a product must nevertheless be treated slimming products, a product presented as facilitating diges- tion, a product presented as stimulating blood circulation, an as a "medicinal product" and subjected to the anti-itching product, an anti-fatigue product, a product for pains in the joints and a method for stopping smoking; relevant rules if it is presented for treating or Case C-60/89 Monteil and Sananani [1991] ECR I-1547, concerning 70% modified alcohol and 2% eosin; preventing disease or if it is intended to be the Upjohn judgment, cited in footnote 9, concerning a lotion administered with a view to restoring, cor- for preventing alopecia androgenetica, i. e. natural loss of hair, recting or modifying physiological func- Case C-219/91 Ter Voort [1992] ECR I-5485, concerning tions.' 15 dried plants for teas, which were presented as products with therapeutic qualities or as supplements to medicinal prod- ucts; Case C-290/90 Commission v Germany [1992] ECR I-3317, concerning lotions, imported from another Member State, for cleansing the eyes. 15 — See the Upjohn cited in footnote 9, paragraphs 30 to 32.

23. In addition, a product which in some Member States is regarded as a foodstuff or cosmetic product is regarded in others as a medicinal product. O n this point the Court observes that 'at the present stage of develop- ment of Community law, it is difficult to avoid the continued existence, for the time being and, doubtless, so long as harmonisa- 22. The cases already decided by the Court tion of the measures necessary to protection give the necessary guidance for answering the of health is not more complete, of differences question whether a product is covered by Directive 65/65. The starting point is always that the Directive gives two definitions of 17 — I fail to sec how this product could be regarded as a medicinal 'medicinal product': one by reference to pre- product by virtue of function. As the Commission correctly argues, the composition of the preparation does not permit sentation and one by reference to function; a the properties specified in Article 1(2), second subparagraph, of Directive 65/65 to be ascribed to i t .Moreover there can product is a medicinal product if it satisfies be no question that the use of the toothpaste here 'signifi- either of those definitions. 16In my view, the cantly affects the metabolism' (see the Court's observations in the Upjohn judgment, footnote 9 above, and paragraph 20 determining factor in deciding the present of this opinion). Finally, the French Government's statement that the fluorine content in the composition of 'Odol-Med case is the criterion of the 'presentation' of 3 (Samtweiss)' exceeds normal values and therefore the toothpaste is a medicinal product by virtue of presentation has in no way been proved. 18 — See the Van Bennekom judgment cited in footnote 14, para- graph 17, and the Upjohn judgment cited in footnote 9, 16 — This was the meaning attached to Article 1(2) of Directive paragraph 16. 65/65 by the judgments in the cases Monteil and Sammani, 19 — See the Delattre judgment cited in footnote 14, paragraph Ter Voort and Commission v Germany, cited in footnote 14. 12.

25. It follows that Directive 65/65 is designed 23 — See the Ter Voort judgment, cited in footnote 14, paragraph not only to regulate preparations suitable for 25. 24 — Avoidance of the risk that consumers may mistakenly assume that a product is a means of treatment is clearly and directly addressed by Council Directive 80/777/EC of 15 July 1980 on the approximation of the laws of the Member States 20 — See the Commission v Germany judgment, cited in footnote relating to the exploitation and marketing of natural mineral 14, paragraph 16. See also the Monteil and Samanni judg- waters (OJ 1980 L 229, p. 1). Article 9(2)(a) of this directive ment (paragraph 27 et seq.) and the Delattre judgment (para- provides that 'all indications attributing to a natural mineral graph 28 et seq.), cited in footnote 14. water properties relating to the prevention, treatment or cure of a human illness shall be prohibited'. This provision 21 — See the Van Bennekom judgment, cited in footnote 14, para- does not apply to the present case, but it shows the impor- graph 17 (emphasis added). tance attached by the Community legislative authority to 22 — See the Upjohn judgment, cited in footnote 9, paragraph 16, preventing the use of statements of a pharmacological nature and the Ter Voort judgment, cited in footnote 16, paragraph in the marketing of a product which (by nature) is not a 14. medicinal product.

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to which it is sold, its familiarity to consumers as a medicinal product by virtue of its pre- and the risks which its use may entail'. 25 sentation'. 27

I-444 ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL

(tablets, pills or capsules) but also that of the sion the average consumer forms of a product packaging of the product, which may, for rea- and how it is presented on the national market sons of marketing policy, tend to make it concerned. 30 resemble a medicinal product. In the second place, account must be taken of the attitude of an averagely well-informed consumer, in whom the form given to a product may inspire particular confidence similar to that normally inspired in him by a proprietary medicinal product, having regard to the safeguards nor- mally associated with the manufacture and (b) Community-law definition of 'medicinal marketing of the latter type of product. product' and 'Odol-Med 3 (Samtweiss)' tooth- paste

In those circumstances, a product may be regarded as a medicinal product by virtue of its presentation if its form and the manner in 31. I now wish to consider 'Odol-Med 3 which it is packaged render it sufficiently (Samtweiss)' toothpaste from the two legal similar to a medicinal product ..." 29 viewpoints mentioned above.

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31 — Paradontopatbie: any complaint characterised by a disorder of the periodontium. Such complaints are the main cause of 33 — It is only in exceptional cases that the facts are made clear the loss of teeth after the age of 30 (Larousse Médical, to the Court in such a way that it can classify a product p. 761, Larousse-Bordas 1998). according to the appropriate Community definition. This 32 — The Commission uses the same words in the account of the occurred in the judgment in Case C-315/92, cited in foot- facts in its written observations, which were received by the note 12, and I shall revert to this in the following paragraph Court on 23 May 1997. of my opinion.

I-446 ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL

35. In my opinion, these arguments, on which the Commission bases its conclusion that 'Odol-Med 3 (Samtweiss)' should not be clas­ sified as a medicinal product, are weighty, but not sufficient to justify that conclusion. Firstly, the fact that the advertising of the product as 36. Therefore, in addition to what has been having favourable effects for the prevention said above, it is also necessary to consider the of paradontosis only complements its presen­ criterion of the 'average consumer', namely tation on the market as having primarily and how the average buyer regards 'Odol-Med 3 principally cosmetic and cleaning effects is (Samtweiss)' toothpaste, taking account of not in itself sufficient to justify the conclu­ how the product is presented and advertised. sion, when Community law is applied, that This question must be answered by the the average consumer will not regard the national court, which is aware of the exact toothpaste concerned as a specific (albeit ancil­ facts of the case, trade customs and consumer lary or supplementary) means of preventing habits in Austria, and can therefore make a disease within the meaning of the first proper assessment of these factors. However, Community-law definition of 'medicinal I think I must point out here that, to classify product' in Article 1 of Directive 65/65. 3 5 'Odol-Med 3 (Samtweiss)' as a medicinal product within the meaning of Directive 65/65, it is not sufficient merely to have regard to the reference, in the presentation of the tooth­ 34 — See the Van Benntkom judgment, cited in footnote 14, para­ graph 19. paste concerned and in the advertising, to its 35 — Factors which could induce the average consumer to ascribe pharmaceutical properties to the product in question are, in addition to the reference to 'prevention of paradontosis' and the inclusion of 'Med' in the name of the toothpaste, the words 'clinically tested', all of which appear on the tube. For 36 — See the Ter Voort judgment, cited in footnote 14, paragraph the last-menāoned, see the Delattre judgment, paragraph 41. 21 (emphasis added).

38. The question referred by the national court concerns the validity of the prohibition under national law which goes further than the provisions of Directive 76/768. First, it 37. When Community law is applied to this must be observed that, in the context of a ref- case, it will be necessary to distinguish and to erence for a preliminary ruling, the Court choose between two possibilities. Does the cannot give a ruling on the compatibility of presentation or advertising of 'Odol-Med 3 national provisions with Community law. It (Samtweiss)' toothpaste on the Austrian can, however, provide the national court with market clearly ascribe preventive effects to all appropriate material on the interpretation the product in relation to disorders of the of Community law to enable it to determine, gums in such a way that the average con- when giving its decision, whether the national sumer may take the view that it falls outside provisions are compatible with Community the general category of toothpaste and can, as law. 37 a 'medicinal product', give him comprehen- sive and effective protection? Or is it pre- sented as a product which gives only general protection against tooth decay and gum dis- orders, in other words, a form of protection which the average consumer can expect from the mere use of a toothpaste as a product which is not regarded as a medicinal product, but only as a cosmetic product with positive 39. In the present case it is characteristic that, effects on health? In the first case, 'Odol-Med although the parties which have submitted 3 (Samtweiss)' must be classified as a medicinal written observations or have appeared before product by virtue of presentation and it will the Court take differing views of the law, be covered by Directive 65/65, which makes ultimately they do not propose replies which it unnecessary to reply to the question referred contradict each other or are totally incompat- by the national court. In the second case, that ible with each other. Apart from Unilever, the is to say, if it is found that, because of the parties appear to agree in principle that a way in which it is presented on the Austrian national prohibition which exceeds the limits market and the resulting impression in the laid down by the relevant Community law, mind of the average consumer concerning its particularly Directive 76/768, is contrary to properties, the product in question cannot be Community law. However, this does not mean regarded as a medicinal product by virtue of that they have the same ideas on the scope of presentation, the directives on cosmetics must be applied and it will be appropriate to reply to the question from the national court. This 37 — Sec the Verband Sozialer Wettbewerb judgment, cited in is what I now propose to do. footnote 12, Opinion of Advocate General Gulmann, para- graph 9.

'A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or ...'. reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal as well as any other indi- cation or information provided by the manu- facturer or his authorised agent or by any other person responsible for placing the Article 6 of Directive 76/768 provides as fol- product on the Community market. lows:

' 1 . Member States shall take all measures nec- The provision of such warnings shall not, in essary to ensure that cosmetic products may any event, exempt any person from compli- be marketed only if the container and pack- ance with the other requirements laid down aging bear the following information in indel- in this directive.' ible, easily legible and visible lettering; the

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information mentioned in point (b) may, how- Article 7(1) of Directive 76/768 is worded as ever, be indicated on the packaging alone. follows:

' 1 . Member States may not, for reasons related (a) ... to the requirements laid down in this Direc- tive and the annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the require- ments of this directive and the annexes thereto.' (g) ...

41. Unilever contends that the national laws on cosmetic products were not completely harmonised by Directive 76/768 as it does determine exhaustively which substances may be contained in such products and when state- ments for the purpose of health protection may or may not be placed on them. In Uni- lever's submission, a national legislation of the kind in question, which aims to protect health, does not fall within the ambit of sec- ondary Community legislation, particularly Directive 76/768. With regard to Article 30 of the EC Treaty, Unilever contends that the 43. The Austrian Government contends, national measures in question fall within the firstly, that Directive 76/768 does not regulate exceptions permitted by Article 36 of the exhaustively the composition and the manda- Treaty to the general prohibition of obstacles tory ingredients of cosmetic products. In any to the free movement of goods as they con- case, Article 6(3) has fully harmonised the cern the protection of health and of con- national laws concerning their packaging and sumers. labelling. This provision was implemented in national law by Paragraph 26 in conjunction with Paragraph 9 of the LMG, thus prohib- iting, firstly, the use of statements relating to health (with the exception of non-misleading references to the physiological or pharmaco- logical effects of cosmetic products and figu- rative representations for explaining their range of application). Secondly, it is prohib- ited to market products bearing false state- 42. Smithkline contends that Article 6(3) of ments. 38 In addition, for avoiding misleading Directive 76/768 constitutes a complete har- advertising Austria has a system of 'positive' monisation of national laws on the packaging, lists, which permits claims concerning certain labelling and advertising of cosmetic products characteristics and statements to promote sales and lays down the restrictions on trade which of cosmetic products only if the products in are necessary to protect health. By virtue of question contain substances which, according that provision the Member States can pro- hibit only advertising which attributes to cos- metic products characteristics which they do 38 — For the actual wording of the Austrian provisions, see foot- not possess. On the other hand, national rules note 5 of this opinion.

46. The Commission begins by observing that the main problem of interpretation in this case is bound up with the question whether Directive 76/768 regulates the permitted com- position of cosmetic products and thus har- monises the national law on that subject. The Commission points out that the Directive has the object of protecting health and therefore prohibits the marketing of cosmetic products containing dangerous or harmful substances. 44. The Government of the United Kingdom Provision is made for the annexes of the contends that under Article 6(3) of Directive Directive listing the prohibited substances to 76/768 the Member States have not only a be constantly updated and amended. As the right, but also an obligation to adopt mea- Community legislature has drawn up a nega- sures to protect consumers against misleading tive list of unauthorised substances and has advertising for cosmetic products. Therefore thereby prohibited the sale and advertising of a national measure which is enacted for that products containing such substances, it must purpose cannot be contrary to the Directive. be presumed that cosmetic substances con- If it were found that the measure in question taining none of those substances can be mar- was not within the scope of the Directive, it keted and advertised freely. Moreover, to give would in any case be covered by the grounds consumers the greatest possible protection, of justification set out in Article 36 of the EC Article 12 lays down an exceptional proce- Treaty. dure whereby the marketing of cosmetic

39 — This is the contrary inference from the judgments in Case C-150/88 Parfumerie-Fabrik Glockengasse [1989] ECR 3891, 47. I propose first to consider Directive paragraph 28; Case C-246/91 Commission v France [1993] 76/768 in order to determine the extent and ECR I-2289, paragraph 7, and the Verband Sozialer Wet- tbewerb judgment, cited in footnote 12, paragraph 11. These degree to which it has harmonised national judgments assume that Directive 76/768 led to complete har- monisation (only) of the national provisions on the pack- laws (a), and then I shall look more closely at aging and labelling of cosmetic products. Subsequently it the precise limits laid down by the directive became apparent that the Directive on its own had not achieved the complete harmonisation of all national provi- to the validity of the national rules (b). sions concerning these products.

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50. After these preliminary remarks, I now wish to consider the relevant provisions of the Directive in relation to the case-law. As the Commission rightly observes, the main aim of the Community legislature is to ensure 52. In addition, Article 6 of Directive 76/768 the free movement of cosmetic products within lays down provisions on the packaging and a system which permits them to be marketed labelling of cosmetic products. The Court has irrespective of prior approval of their com- consistently held that these provisions con- position, provided they do not contain stitute a complete harmonisation of national substances harmful to human beings, dan- laws on the packaging and labelling of such gerous substances or dangerous quantities of products. It did so first in the Parfumerie- substances. That is the purpose of the so-called Fabrik Glockengasse judgment 42 and was fol- negative list. The directive has two annexes, lowed later in the Commission v France 43 and one listing substances which are not permitted the Verband Sozialer Wettbewerb judg- in cosmetic products, the other listing ments. 44 Consequently, it is no longer open substances the use of which is subject to cer- to the Member States to keep in force or to tain restrictions. Article 4 of the directive requires the Member States to prohibit the marketing of cosmetic products the composi- tion of which does not conform with the 41 — According to this procedure, if a Member State finds that a cosmetic product, although complying with the require- prohibitions and restrictions of the negative ments of the directive, represents a hazard to health, it may list. This is also the only restriction to which provisionally prohibit the marketing of the product or sub- ject it to special conditions on marketing. At the same time such products are subject 'with regard to their the Commission and the other Member states must be informed and the Member State concerned must state the grounds for its decision. 42 — See the judgment cited in footnote 39, paragraph 28. 43 — See the judgment cited in footnote 39, paragraph 7. 40 — See paragraph 52 below. 44 — See the judgment cited in footnote 12, paragraph 11.

apply national provisions concerning the pack- which is the most recent decision on the aging and labelling of cosmetic products if interpretation of the provisions in question, those provisions go further than the condi- the Court cast doubt on the conclusion it tions directly laid down by the Directive. This reached in Parfumerie-Fabrik Glockengasse. is the reason why the Community legislature In particular, although the Court accepts that expressly provides in Article 7 of the Direc- Directive 76/768 provided exhaustively for tive that 'Member States may not, for reasons the harmonisation of national rules on the related to the requirements laid down in this packaging and labelling of cosmetic products, directive and the annexes thereto, refuse, pro- it adds that 'this directive must, like all sec- hibit or restrict the marketing of any cos- ondary legislation, be interpreted in the light metic products which comply with the of the Treaty rules on the free movement of requirements of this directive and the annexes goods'. 46 Pursuing this line of reasoning, the thereto'. Court goes on to consider whether the national legislation implementing the provision of the Directive which require the Member States to take all the appropriate measures for pre- venting misleading advertising of cosmetic products conforms not only with the limits 53. But is Article 6 of the Directive the only and conditions laid down by that provision Community-law provision applying to the of secondary Community legislation, but also packaging and labelling of cosmetic products, with Articles 30 and 36 of the Treaty, as inter- or should Articles 30 and 36 of the EC Treaty preted by the Court. 47 also apply? In principle I consider that the reply to this question is that Article 6 of the Directive alone applies. This was also the conclusion reached by the Court in the Parfumerie-Fabrik Glockengasse judgment, where it states that 'since the directive has provided exhaustively for the harmonisation 55. In any case, it is of some practical impor- of national rules on the packaging and label- tance whether the question of the extent to ling of cosmetic products, it is not necessary which a national measure on the packaging to give a ruling on the interpretation of Article and labelling of cosmetic products is compat- 30 of the Treaty as requested by the national ible with Community law is assessed only by court.' 45 The same view is taken in the present reference to Article 6 of Directive 76/768 or case by Smithkline, the Commission, the also in the light of Articles 30 and 36 of the French Government and the Government of EC Treaty. Let me explain: the United Kingdom.

— On the other hand, the protection of con- 56. However, the assessment of a national sumers against the risk of deception also measure concerning advertising for a cosmetic falls in fact within the ambit of primary product and its presentation generally, by ref- Community law on the free movement of erence to Article 6(3) of Directive 76/768 and goods, namely Article 30 et seq. of the Article 30 et seq. of the Treaty gives rise to EC Treaty. In the Yves Rocher judgment 48 two serious problems: the Court observed that 'the protection of consumers against misleading advertising is a legitimate objective from the point of view of Community law'. 49 Similarly in Mars 50 the Court stated that 'it is settled

— Firstly, the assessment of a national mea- sure of that kind in the light of the objec-

48 — Case C-126/91 [1993] ECR I-2361. 49 — Cited in footnote 48, paragraph 15. 50 — Case C-470/93 [1995] ECR I-1923. 51 — See the judgment cited in footnote 50, paragraph 15.

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The national measure may only have as its purpose and subject-matter the prohibition of any pre- sentation of cosmetic products on the market which implies a characteristic which the products in question do not actually have. O n the other hand, a national 52 — There are two trends in the Court's case-law. Originally it provision prohibiting certain forms of was decided that legislation which restricts or prohibits cer- advertising would exceed the limits of the tain forms of advertising and certain methods of sales pro- motion may, although it does not directly affect imports, be power conferred by the said such as to restrict their volume because it affects marketing opportunities for the imported products. It may therefore Community-law rule if that advertising constitute an obstacle to imports and fall within the scope of Article 30 of the EC Treaty even if the legislation in ques- does not imply that the cosmetic products tion applies to domestic products and imported products in question have characteristics which they without distinction (see the judgments in Case 286/81 Oost- hoek's Uitgevermaatschappij [1982] ECR 4575, paragraph do not have within the meaning of Article 15; Case 382/87 Buet and Others [1989] ECR 1235, para- graph 7; Case C-362/88 INNO [1990] ECR I-667, para- 6(3) of the Directive.

In these cases the Court reasoned as follows: 'by contrast, contrary fied, on the one hand, as a mere 'method to what has previously been decided, the application to products from other Member States of national provisions of sales promotion' and would therefore restricting or prohibiting certain selling arrangements is not such as to hinder directly or indirectly, actually or poten- fall outside the scope of Article 30; 53 on tially, trade between Member States within the meaning of the Dassonville judgment so long as those provisions apply the other hand, it might be regarded as a to all relevant traders operating within the national territory measure necessary for the protection of and so long as they affect in the same manner, in law and in fact, the marketing of domestic products and of those from health, in which case it would fall under

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57. For these reasons — and also to clarify et seq. of the Treaty. The Court merely wished the case-law — I think it preferable for the to emphasise that national measures imple- Court not to embark on the tricky task of menting the obligation under Article 6(3) of judging a national provision concerning the the Directive to take steps against misleading packaging, labelling and advertising of cos- advertising for cosmetic products are compat- metic products by reference to both Direc- ible 'with Community law only if they are tive 76/768 and the Treaty. In so far as the necessary and conform to the objective pur- Court has held that the relevant rules of sec- sued, that is to say, they do not unreasonably ondary Community legislation, contained in impede the free movement of goods. In other Article 6 of the Directive, provided exhaus- words, in the Verband Sozialer Wettbewerb tively for the harmonisation of national rules judgment the Court rightly made it clear that, on the packaging and labelling of cosmetic in enacting national measures to implement products, those rules are, in my opinion, the the provisions of the Directive which provide only legal basis for determining how far the for comprehensive harmonisation in the field national provision in question is compatible of the packaging and labelling of cosmetic with Community law. Therefore any refer- products, the national legislature still has an ence to Article 30 et seq. of the Treaty must obligation to observe the principle of propor- be avoided, particularly with regard to the tionality and to choose the restriction which packaging and labelling of cosmetic prod- will have the least effect on the free move- ucts. 55 ment of goods. The national legislature would be under the same obligation if there were no special provision of secondary Community legislation and it were a question of applying Article 30 et seq. of the Treaty directly.

laws on the packaging and labelling of tion of national measures restricting the cosmetic products must not be construed presentation, placing on the market and so narrowly that the advertising of those advertising of cosmetic products so as products would be excluded from the automatically to remove such measures ambit of such harmonisation. In other from the scope of Article 6(3) and to bring words, the advertising of cosmetic prod- them within the more general ambit of ucts is also the subject of complete har- Article 30 et seq. of the Treaty (particu- monisation brought about by Article 6(3) larly Article 36). As there is no doubt that of Directive 76/768. This means that the complete harmonisation of the rules only measures in relation to consumer relating to labelling, advertising and, gen- protection which the national authorities erally, the presentation of cosmetic prod- may take with regard to such advertising ucts has been achieved, Article 30 et seq. are those which they are authorised by can no longer be invoked in order to gain the Community legislature to take under acceptance for a national measure as com- Article 6(3) of the Directive. plying with the requirements of Commu- nity law if that measure relates to the same subject-matter as the Directive and con- flicts with it.

(b) National measures restricting the free is to say in the context of implementing movement of cosmetic products from the Article 6(3) of Directive 76/768, the national viewpoint of Directive 76/768 authorities take measures which infringe the first fundamental rule of the Directive? In other words, what becomes of a national measure which, to prevent misleading adver- tising, interferes with the free movement of cosmetic products goods irrespective of their composition? In my opinion, such a measure is not compatible with the letter or the spirit of the Directive. Otherwise, that is to say, if it were accepted that the adoption of mea- sures to prevent misleading advertising neces- 61. The limits within which the national leg- sarily entail setting aside the regime of free islature may regulate the cosmetic sector are movement of cosmetic products irrespective clear from the foregoing observations. As I of their composition, this would amount to a have said, the fundamental purpose of the recognition that there are fundamental con- Directive is to ensure the free movement and tradictions in the Directive and therefore that marketing of cosmetic products which do not the Community legislature had failed com- contain substances or quantities of substances pletely in its work of regulation. However, dangerous or harmful to the health of human not only is there no conflict between the two beings. Consequently, the Member States basic aims of the Directive, namely ensuring cannot in principle impose restrictions 'with the free movement of cosmetic products and regard to their composition' which differ from preventing their being placed on the market those exhaustively provided for in the Direc- with untrue or misleading statements or adver- tive. At the same time, however, the Member tising, but those two aims can be achieved States must take the necessary measures to simultaneously. That is the true intention of prevent misleading advertising for cosmetic the Community legislature, and the Member products. Therefore a national measure is compatible with Community law if it pro- States are required to comply with it when hibits the marketing of such products with adopting measures to implement Article 6(3) false, untrue or misleading statements and, in of the Directive. any case, with a presentation such as to attribute to them characteristics which they do not have.

national authorities with a view to preventing of restrictions on their composition. To be misleading advertising for cosmetic products more precise, national legislation which, for is particularly limited. As the Court observed cosmetic products to claim certain character- in the Parfumerie-Fabrik Glockengasse judg- istics (in connection with labelling, presenta- ment, the obligation under Article 6(3) of the tion and advertising), requires such products Directive to take all necessary measures 'does to contain certain substances listed in national not authorise Member States to require infor- sources of law (according to national law, mation not provided for in the directive on these are the only substances which scientifi- the labelling or packaging of those prod- cally correspond to those characteristics) is ucts'. 56 In the same judgment the Court directly contrary to the intention of the Com- indeed took the view that the aim of pro- munity legislature that the marketing of a tecting consumers 'may be achieved by means cosmetic product is not to depend on prior less restrictive of Community trade'. 57 The authorisation of its composition by the Court also made the following important national authorities. In national legislation of observation: 'it appears from a comparison of this kind the principle of the free movement the national provisions adopted for that pur- of cosmetic products containing none of the pose that certain Member States have laid dangerous of harmful substances exhaustively down a general prohibition of any indication listed in the Directive is relegated to the status likely to mislead the consumer. There is of a mere exception. Conversely, where cos- nothing to suggest that such a general prohibi- metic products are free from restrictions under tion is inadequate to achieve the desired end'. 58 national law only if their composition con- forms with the relevant national provisions, 59 this means in reality that a system of prior authorisation for those products has been introduced, contrary to the aim of the Direc- tive.

ments of the Directive. The ratio of a posi- to advertise a product. To avoid any misun- tive list of substances which cosmetic prod- derstanding, the Community legislature has ucts must contain (although it is justified by in its wisdom furthermore expressly prohib- the aim of improved protection for con- ited misleading presentation as the sole restric- sumers) in order that certain characteristics tion on the freedom to advertise cosmetic may be ascribed to them goes beyond the products. 60 enabling power conferred by Community law. In a system of this kind, there is no examina- tion in each individual case to establish whether the product produces the effects which are supposed to result from using it. The product must 'automatically' contain the substances which, in the opinion of the national authorities, produce the effects in question. Furthermore, a manufacturer who claims to have found a new substance capable of producing certain effects must obtain a special authorisation before marketing the cos- metic product.

67. From what I have said it follows, in my opinion, that national legislation such as that described above, which is not confined to a general prohibition of misleading advertising, but goes further and sets up a system with a positive list of permitted substances which

I-462 ÖSTERREICHISCHE UNILEVER v SMITHKLINE BEECHAM MARKENARTIKEL

determines whether a cosmetic product can the Community legislature. A national pro- be marketed freely, is contrary to Directive hibition of that kind unduly restricts the 76/768. freedom to trade in cosmetic products and is contrary to Community law. I am led to this conclusion by merely interpreting and applying the relevant provisions of Directive 76/768 which have exhaustively harmonised the law concerning the advertising of cos- metic products, and it is unnecessary to search for legal solutions on the basis of Article 30 et seq. of the E C Treaty. 62

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VI — Conclusion

69. O n the basis of all the foregoing considerations, I propose that the Court reply to the question from the national court as follows:

(1) A toothpaste is to be regarded as a cosmetic product within the meaning of Community law and is covered by Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cos- metic products unless the averagely well-informed consumer may infer with certainty, from the statements on the packaging of the product, from adver- tising and generally from its presentation for sale, that it is a substance pre- sented for treating or preventing disease within the meaning of Council Direc- tive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

(2) National legislation which, in order to give consumers improved protection against misleading advertising, and for the sake of protecting health, on the one hand, prohibits advertising of cosmetic products by means of misleading state- ments concerning health and, on the other hand, introduces a national control system on the basis of which a cosmetic product cannot be presented on the market as producing certain effects if its composition does not include the substances which, in the view of the national legislature, alone justify and con- firm the claim that it has such effects, it being necessary in that case to obtain special prior authorisation to advertise and to market the product, goes further than the restrictions authorised by Article 6(3) of Directive 76/68 and is there- fore incompatible with Community law.