C-99/01

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3. According to Article 4 of Council Direc- 5. Pursuant to Article 26(2) of the LMG, tive 84/450/EEC of 10 September 1984 Article 8(a), (b) and (f) applies by analogy relating to the approximation of the laws, (to the marketing of cosmetic products), regulations and administrative provisions while Article 9 applies upon the under- of the Member States concerning mislead- standing that non-misleading references to ing advertising 3 'Member States shall physiological or pharmacological effects, as ensure that adequate and effective means well as figurative representations and illus- exist for the control of misleading advertis- trations intended to explain the scope of ing in the interests of consumers as well as the use of the product are permissible. competitors and the general public'. Where such effects are ascribed to a Article 7 provides that Directive 84/450 product, the authorities must, upon shall not preclude Member States from request, be notified of the active ingredi- retaining or adopting provisions with a ents. view to ensuring more extensive protection for the persons mentioned above.

III — Facts, procedure and reference for a preliminary ruling

(b) to refer to case histories, recommen- dations by doctors or medical experts' opinions; 10. By a decision of the Unabhängige Verwaltungssenat Wien dated 22 February 1999, Gottfried Linhart (hereinafter: 'Mr Linhart') was found guilty of an adminis- trative offence under Article 74(1) in con- junction with Articles 9(1 )(a) and 8(f) of the LMG on the ground that he had been ...'. responsible for the supply by Colgate Palmolive Gesellschaft m.b.H. of the prod- uct 'Palmolive flüssige Seife Prima Anti- bakteriell' marked 'dermatologically tested' to Billa AG. 5 That description of the soap gave consumers the impression that it had a health-maintaining effect and thereby, in the opinion of the Unabhängige Verwal- tungssenat, caused the product to be incor- 8. Pursuant to Article 9(3) in conjunction rectly described. with Article 26(2) of the LMG the Minister is to allow, upon request and by decision, health-related information for certain cos- metic products when this is consistent with protecting the consumer from being misled.

11. Dr. Hans Biffi (hereinafter: 'Dr Biffi') was found guilty by a decision of the Unabhängige Verwaltungssenat for Lower Austria dated 9 May 2000 of an adminis-

9. Under Article 74(1) of the LMG a per- 5 — The Verwaltungsgerichtshof did not remark on the origin of son who, inter alia, incorrectly describes the cosmetic products at issue. In his written observations, Mr Linhart stated that the product 'Palmolive flüssige Seife cosmetic products or who markets incor- Prima Antibakteriel!' had been manufactured in Italy.

12. In the appeal before the Verwaltungs- gerichtshof against those decisions, the appellants argued, on the basis of the judgment of the Court of Justice dated 28 January 1999 in Unilever, 7that, inter alia, the national legislation in question was in breach of Community law, in particular because national provisions 15. On the other hand, the reference to which prohibit the advertisement of cos- medical reports ('clinically tested', 'derma- metics using non-misleading health-related tologically tested') when marketing cos- descriptions exceed the limits of the dis- metic products has been regarded as per- cretion conferred on the Member States by missible under Article 26(2) of the LMG, Article 6(3) of Directive 76/768. where it is stated that the test — regardless of its consequences on human health — concerned specific physiological or phar- macological effects of the product involved, such as the statement 'clinically tested for skin tolerability and the removal of the hair together with the root' upon the marketing 13. The Verwaltungsgerichtshof had of a hair removal product. already been called upon on several occa- sions to determine the permissibility of the descriptions 'clinically tested' and 'derma- tologically tested' in cases which arose prior to the Austrian Republic's accession to the European Economic Area and the European Union.

6 — I gather that the product involved was an anti-dandruff shampoo. 16. The referring court takes the view that 7 — Case C-77/97 Österreichische Unilever v Smithkline Bee- cham Markenartikel [1999] ECR I-431. the question whether the Austrian provi-

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the use, in particular, of the description Verwaltungsgerichtshof has reasoned and "clinically tested" or "dermatologically worded its reference for a preliminary tested", if erroneous ideas as to the ruling. characteristics and functioning of the cosmetic product could be engendered in the mind of the consumer as a result of a lack of information as to the content and outcome of the opinion in question? 22. This criticism is partly factual in char- acter. Mr Linhart has argued that apart from the description 'dermatologically tes- ted' the packaging of the soap in question did actually give additional information. (2) Do Articles 28 and 30 EC, Directive Below the words 'Schutz gegen Bakterien' 76/768, in particular Article 6(3) (protection against bacteria) the product thereof, and Directive 84/450, in par- carried information concerning the subject ticular Articles 4 and 7 thereof, pre- and outcome of the dermatological tests. clude national legislation which per- Mr Linhart and Dr Biffi have further mits information coming within the argued that the description 'dermatologi- terms of question 1 to be used only cally tested' appearing on their products is after prior authorisation by the com- in itself correct and that, contrary to what petent Federal Minister?' the first question suggests, given the way in which the description is used on the packaging, it could not give the consumer the wrong impression.

20. Written observations have been sub- mitted by Mr Linhart, Dr Biffi, the Govern- ment of the Republic of Austria and the European Commission. No oral arguments were heard. 23. In that respect, I would merely point out that it is for the national court to establish the facts in the main proceedings and to assess the relevance of the questions to be put to the Court of Justice.9 The scope of the concept of misleading advertis- ing, furthermore, concerns a matter that is IV — Assessment in fact central to the first question.

I - 9382 'clinically tested' raised in the reference for were tested with what results, and (b) no a preliminary ruling bears no connection to authorisation for its use was applied for. 12 the two cases in the main proceedings, where the dispute exclusively concerns the description 'dermatologically tested'. The national court has, however, dealt with the description 'clinically tested' before, as described in the order for reference. It is 26. The two preliminary questions concern conceivable that the Verwaltungsgerichts- the interpretation of Articles 28 and 30 EC, hof would appreciate receiving a broader Directive 76/768 and Directive 84/450.

25. The referring court thus essentially asks national regulations must therefore, in my whether Community law precludes national legislation which, in the interpre- tation given to it by national case-law, 12 — For the sake of completeness it should be noted that several prohibits the use of the description 'derma- similar references for preliminary rulings are currently pending before the Court in which Austrian courts have tologically tested' in cases where (a) those raised questions concerning the compatibility of provisions from the LMG with Community law. Furthermore, in a tests are not described and no indication is procedure for a declaration of failure to fulfil obligations given as to which properties of the product the Commission has requested the Court to determine that that same Law is contrary to Community law where the labelling of foodstuffs and, in particular, health-related descriptions are concerned (case C-221/00 of 23.1.2003, not yet published in the ECR). 10 — That might also explain why Article 9(l)(a) of the LMG, 13 —Cases C-150/88 Parfiimerie-fabrik 4711 11989) ECR the provision which Mr Linnart has allegedly breached, is 3891, paragraph 28, C-315/92 Verband Sozialer Wettbe- no longer referred to in the description of the existing legal werb [1994| ECR I-317 (commonly referred to as 'Cli- situation concerning health-related descriptions, as out- nique'), paragraph 11, Unilever, cited in footnote 7, lined in paragraphs 13-15 of this Opinion. The Verwal- paragraph 24, Estée Lauder, cited in footnote 8, paragraph tungsgcrichtshor's case-law on the matter appears to be based mainly on Article 9(1 )(b) of the LMG. 14 — As was recently confirmed in case C-324/99 Daimler- 11—See, inter alia, Joined Cases C-297/88 and C-197/89 Chrysler AC v Land Baden-Württemberg [2001] ECR Dzodzi v Belgian State |1990| ECR I-3763, paragraph 40. I-9897, paragraph 32.

view, be assessed exclusively in the light of 29. Concerning the relationship between Article 6(3) of Directive 76/768, and not in Directive 76/768 and Directive 84/450, it is the light of Articles 28 and 30 EC, even my opinion that the Commission, Mr though that provision of the directive must, Linhart and Dr Biffi are right to argue that like all secondary legislation, be interpreted Article 6(3) of Directive 76/768 has prior- in the light of the Treaty provisions con- ity over the provisions of Directive 84/450 cerning the free movement of goods. 15 As according to the principle of Hex specialis will emerge below, that latter point is derogat legi generali'. In my view, there- important in determining the scope of fore, the Court does not need to consider Article 6(3) of Directive 76/768 and the Directive 84/450 as part of its answer. That Member States' discretion on the basis of Directive contains rather generally worded that provision. obligations which describe in relatively vague terms what is to be considered misleading. Directive 76/768 on the other hand, in Article 6(3), contains a specific rule which prohibits misleading infor- mation on the packaging and labelling of the products covered by the Directive. Given the completeness of harmonisation in this matter, the Member States are not permitted to deviate from the conditions laid down in that provision. That means, for example, that consumers cannot be given a higher level of protection against being misled, even by relying on Article 7 of Directive 84/450, which considers further-reaching protection permissible. 17 28. In that regard, the Court's case-law on the labelling and advertising of cosmetic products proves to be somewhat incon- sistent. In the decisions in Clinique and Estée Lauder the Court assessed the national rules in question both in the light of Articles 28 and 30 EC and in the light of the relevant provision from Directive 76/768. On the other hand, in Vnilever B — The first question the national rules were, rightly in my view, tested only against the Directive and not against the primary legislation, even though the referring Austrian court in that case also sought an i n t e r p r e t a t i o n of 30. In order to answer the first question it Article 28 EC. 16 should first be assessed whether

33. However, the measures which the Member States are required to take in order to implement this provision must observe the principle of proportionality.19 31. To begin with, it is not disputed that In its assessment of the risk of the consumer the products at issue — soap and sham- being misled on the one hand and the poo — are cosmetic products as referred requirements of the free movement of to in Article 1 of Directive 76/768 and that goods on the other, the Court has derived the description objected to, i.e. 'dermato- a standard from the principle of propor- logically tested', falls under the scope of tionality which takes a certain type of Article 6(3) of the Directive. I therefore consumer as its point of departure. In order assume that they should not be regarded as to determine whether a name, trade mark medicinal products, in which case the or promotional statement is liable to mis- Community legislation on medicinal prod- lead, the Court must take into account 'the ucts would apply instead of Directive presumed expectations of an average con- 76/768. Nor do the records on the file sumer who is reasonably well informed and show that the products — apart from the reasonably observant and circumspect' and contested description — have been who wrongly presumes that the product illegally placed in circulation. possesses certain characteristics.20

to the condition that ‘a mistake as to the taken into consideration. Case-law shows product's characteristics cannot pose any that when determining whether a certain risk to public health’. 21 As in Clinique, description or advertisement is misleading Unilever and Estée Lauder, the health of within the meaning of Directive 76/768, the persons is not an actual issue in this case Court takes a critical attitude to national either. The cases concern descriptions provisions which prohibit a statement that which may, either rightly or wrongly, is in itself correct. The principle of propor- create the impression on the part of con- tionality is quick to oppose such provisions. sumers that they possess a certain medicinal The abstract danger of being misled does function. Measures to prevent buyers from not suffice; only in cases where there is a being potentially misled or confused are real risk that the consumer will be misled as not, so it would appear to me, bound up regards essential matters are measures per- with the protection of public health, but mitted which result in the marketing of a rather with the protection of consumers product being made subject to further and the fairness of trade. This distinction is conditions. important in connection with the appli- cation of the principle of proportionality, which in my opinion is not a static concept, but should be examined in the light of the objective pursued. 22

I-9386 (Samtweiß)' toothpaste, according to which traded, it is my contention that the Court the product prevents the formation of has the necessary information to give the tartar or paradontosis, while the product following clarifications to the national contains none of the active substances listed court. in the regulations as substances through which such a result may be achieved. As in the present case, the regulations in question involved, among others, Articles 9 and 26 of the LMG. The list of substances men- tioned was included in an Annex to the Kosmetikverordnung. This Annex, how- ever, did not exhaustively list the sub- stances capable of preventing the formation 38. Cosmetic products such as soap and of tartar or paradontosis. It was therefore shampoo are intended to come into contact possible that the advertising of certain with the skin. It is therefore inevitable that toothpastes was prohibited while it was the products should be tested for their unlikely to mislead the consumer. The effects on the skin before they are first put Court therefore held that Article 6(3) of into circulation. This is essentially what the Directive 76/768 precluded the application description 'dermatologically tested' refers of such regulations. The possibility of to. Dermatology is the science which con- obtaining an authorised exemption from cerns itself with research into skin diseases. that prohibition did not alter the state of Using the term 'dermatologically tested' affairs. 25 therefore implies that it has been investi- gated whether the skin tolerates the prod- uct.

41. From the point of view of the scope of Article 6(3) of Directive 76/768 it is there- fore not necessary to prohibit the use of the description 'dermatologically tested' on the two products involved in order to protect the consumer and the fairness of trade. The argument of the Austrian Government that the national legislation does permit non- misleading references in certain situations of course does nothing to change this.

40. The referring court has pointed out that in accordance with national case-law a reference to a medical report by mentioning a dermatologicai test can at least instil in the consumer the vague notion of some health effect if that reference is not elabor- ated upon. However, even if the description 'dermatologically tested' is capable of C — The second question evoking vague medical associations on the part of some consumers — for example, due to the Greek origin of the word 'dermatological' — this is not sufficient to attribute to it a misleading effect which could justify a prohibition of the descrip- tion if the products are marketed in an 42. Given the above, the second question otherwise lawful manner. There is, in my no longer warrants extensive examination. view, insufficient cause to assume a real Whether Community law precludes a risk that the average consumer will be Member State's regulations allowing the confused or misled. It is, moreover, prima use of the description 'dermatologically facie contrary to the principle of propor- tested' only after prior authorisation by tionality to prohibit only the description the competent minister is already implied in 'dermatologically tested', whereas claims the answer to the first question. Since the containing further-reaching and therefore more suggestive information, such as 'der- matologically tested for skin tolerability 26 — On the basis of earlier case-law of the Verwaltungsgericht- and the removal of the hair together with shof; see paragraph 15 of this Opinion.

45. In conclusion, it should be added that the authorisation in question is even more disproportionate as a measure for protect- 44. That argument is based on an incorrect ing consumers and ensuring the fairness of reading of Unilever and cannot be trade if Dr Biffl's contention that the accepted. In Unilever it was established, procedure under Article 9(3) of the LMG with respect to the same national legis- is not free of charge proves to be true. lation, that, whilst authorisation might be requested, the requirement to obtain such authorisation constituted an impediment to 27 — Unilever, cited in footnote 7, paragraph 34. Emphasis the free movement of the product in ques- added.

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V — Conclusion

46. Based on the above, I propose that the Court should reply as follows to the reference for a preliminary ruling from the Verwaltungsgerichtshof:

(1) Article 6(3) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products precludes the application of national rules in the interpretation given to them by national case-law which, upon the marketing of cosmetic products intended for use on the skin, prohibits a general description, such as 'dermatologically tested', when it has not been indicated which properties of the product were tested and with which results and the manufacturer or distributor of the products in question is not given the opportunity to demonstrate the correctness of the statement.