C-169/99
ECLI:EU:C:2000:637
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OPINION OF MR MISCHO — CASE C-169/99
OPINION OF ADVOCATE GENERAL MISCHO delivered on 16 November 2000 1
1. In this case the Bundesgerichtshof (Ger- may be marketed only if the container and many) seeks a preliminary ruling from the packaging bear the following information Court as to the meaning of the term in indelible, easily legible and visible letter- 'impossible for practical reasons' in the ing: second sentence of Article 6(1)(d) of Coun- cil Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic prod- ucts, 2 as subsequently amended ('the Directive').
I — Legal background
2. The first sentence of Article 6(1) and Article 6(1)(d) of the Directive, as amended (d) particular precautions to be observed by Council Directive 88/667/EEC of in use, and especially those listed in the 21 December 1988, 3provide as follows: column "Conditions of use and warn- ings which must be printed on the label" in Annexes III, IV, VI and VII, which must appear on the container and packaging as well as any special precautionary information on cosmetic products for professional use, in parti- 'Member States shall take all measures cular in hairdressing. Where this is necessary to ensure that cosmetic products impossible for practical reasons, this information must appear on an enclosed leaflet, with abbreviated 1 — Original language: French. information on the container and the 2 — OJ 1976 L 262, p. 169. packaging referring the consumer to 3 — OJ 1978 L 382, p. 46. That directive was to be implemen- ted by 31 December 1989. the information specified.'
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3. Following the adoption of Council 5. The first part of Annex III requires that Directive 93/35/EEC of 14 June 1993, 4 the following warnings be given in respect the last sentence of subparagraph (d) was of those substances as follows: replaced by the following:
— for diaminophenols: 'Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card5 must contain that information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII,6 which must appear on the container and the packaging.' 'Can cause an allergic reaction. Sensitivity test advisable before use. Contains diami- nophenols. Do not use to dye eyelashes or eyebrows.'
II — The facts and the questions referred for a preliminary ruling — for resorcinol:
4. Of the haircare products manufactured and distributed by Hans Schwarzkopf GmbH & Co. KG ('Schwarzkopf'), the range of hair colourings called 'Igora 'Can cause an allergic reaction. Contains Royal' is distributed exclusively to hair- resorcinol. Rinse hair well after applica- dressers and other professional users. It tion. Do not use to dye eyelashes or eye- appears from the order for reference that brows. Rinse eyes immediately if product certain shades of colouring in that range comes into contact with them.' contain chemical substances covered by the Directive, namely diaminophenol and resorcinol.
4 — OJ 1993 L 151, p. 32. This directive was to be implemented by 14 June 1995. 5 — Emphasis added. 6. Similar warnings are laid down for other 6 — Emphasis added. substances.
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7. The Directive also lays down shorter warning in full. Schwarzkopf further repro- warnings such as: duced on the packaging the symbol pre- scribed by Annex 8 to the German cos- metics regulation, which is identical to that laid down by Annex VIII to the Directive, namely a picture of an open book with a finger pointing towards it. — 'Not to be used for babies.'
— 'Avoid contact with eyes.' 9. The Zentrale zur Bekämpfung unlaute- ren Wettbewerbs eV (Office for the Pre- vention of Unfair Competition, 'the ZBUW) considers that this practice infringes the German cosmetics regulation and is anti-competitive. The ZBUW — 'Do not spray into eyes.' brought proceedings against Schwarzkopf to prevent it from placing on the market the products in question without the full warn- ings appearing on the packaging and con- tainer. In the view of the ZBUW this would be feasible if Schwarzkopf confined the full — 'For preparations in aerosol dispensers: warning to the official language of the do not spray on a naked flame.' country of distribution.
— 'Avoid contact with eyes. Can cause blindness. Keep away from children.' 10. Having lost on appeal, 7Schwarzkopf appealed on a point of law to the Bundes- gerichtshof, which ordered:
8. It appears from the order for reference that, instead of printing the prescribed warnings in full on the packaging (box) and the container (a tube) for the products 'The following questions on the interpreta- in this range, Schwarzkopf printed on those tion of the second sentence 8 of Arti- items, in eight official languages of the European Communities and in Arabic, the following: 'For commercial use only. 7 — Decision of the Oberlandesgericht Hamburg of 24 October Important: follow instructions for use and 1996 overturning the decision of the Landgericht Hamburg heed warnings'. Schwarzkopf enclosed with of 24 May 1995 (corrected by decision of 30 June 1995). 8 — German version of the order for reference: 'Art. 6 Abs. 1 lit. each product a leaflet setting out the d Halbsatz 3'.
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cle 6(1)(d) of Council Directive 76/768/ in the languages of the nine different EEC of 27 July 1976 on the approximation countries where the product is sold (which of the laws of the Member States relating to include eight EU Member States)?' cosmetic products (OJ 1976 L 262, p. 169) as amended by Council Directive 88/667/ EEC of 21 December 1988 amending for the fourth time Directive 76/768/EEC (OJ 1988 L 382, p. 46), in conjunction with Articles 30 and 36 of the EC Treaty, are referred to the Court of Justice of the European Communities for a preliminary ruling: III — Preliminary observations
11. Two preliminary observations may be made.
12. The first concerns the terms of the order for reference. According to the word- ing of that order, the Court is asked to Is the term "practical reasons" in the interpret Article 6(1)(d) of the Directive in second sentence 9 of Article 6(1)(d) of the version contained in Directive 88/667. Directive 76/768/EEC to be interpreted as also permitting the inclusion of prescribed warnings in several languages, where the manufacturer or marketer of cosmetic prod- ucts considers it desirable on economic grounds and to enhance the marketability 13. Contrary to the wording of the opera- of the products in the Community, if as a tive part of the order, the referring court, result the full warning appears in a clearly however, remarks in the second subpara- legible format on an enclosed leaflet only, graph of paragraph III. 1 of the grounds of with the packaging and container simply the order that: furnishing abbreviated information for lack of space? Specifically, is it permissible for the packaging and container to carry not the full warning but only abbreviated information where a company, for the reasons given above, considers it desirable to market its products in a uniform get-up 'The dispute between the parties concerns the question whether the defendant may rely on the exception in Article 4(2)(2) of 9 — German version of the order for reference: 'Art. 6 Abs. 1 lit. the cosmetics regulation. The version of tl Halhsatz .V. that regulation which entered into force on
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1 January 1997 applies in this case. It term at issue ('impossible for practical provides...' reasons') has not changed from one version of the Directive to another, I consider that it is permissible to refer to Directive 93/35 in so far as this may throw light on the presumed intentions of the Community legislature. 14. The version of the German cosmetics regulation which entered into force on 1 January 1997 is that which implements Directive 93/35.
18. My second observation concerns the fact that, in the Commission's view, any derogation from the rule only concerns the 15. Furthermore, in its description of the 'special precautionary information on cos- facts, the Bundesgerichtshof states that the metic products for professional use, in packaging reproduces the symbol which particular in hairdressing'. appears in Annex 8 to the German cos- metics regulation. 10 That annex was only added to the cosmetics regulation following implementation of Directive 93/35. 11
19. That interpretation is probably based on the fact that, in the German language version of the Directive prior to Directive 93/35, the different sections of Arti- 16. On the other hand, it was made clear at cle 6(1)(d) were separated by semicolons, the hearing that the action was heard in the such that the passage referring to impossi- German courts on 9 February 1995, that is, bility for practical reasons could be read as after the adoption of Directive 93/35, but referring only to the passage immediately before the expiry of the period prescribed before it, namely that concerning the for implementation, and its entry into force particular precautions to be observed by in German law. professional users. By contrast, in the other language versions the phrase 'Where this is impossible for practical reasons' begins with a capital letter and therefore is to be read as referring to the entirety of the preceding text. 17. Nevertheless, having regard to the passages of the order for reference just cited, and to the fact that, in any event, the
10 — The order for reference states at point I, third subpara- graph, second sentence, of the grounds that: 'Auf der Verpackung befindet sich zusätzlich noch das Symbol 20. In Directive 93/35, that section of gemäss Anlage 8 zur Kosmetik-Verordnung'. 11 — Article 1 (14) provides that: 'Annex VIII to the Directive is subparagraph (d) was changed, in the Ger- appended'. man language version, to a free-standing
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sentence. I do not therefore accept the interpretation given that 'its effect is to give Commission's interpretation. general priority to consumer protection, leaving almost no scope for recognising "practical reasons" when considering indi- vidual cases'. In this regard the referring court cites the second recital of the Direc- tive in support of the contention that the prescribed information need not be repro- 21. Moreover, I have found no reference in duced in full on the packaging and con- the annexes to the Directive to particular tainer in the circumstances of this case. precautions to be observed by hairdressers That recital states that the aim of the or other professional users. Directive is to free cosmetics manufacturers from the barriers to intra-Community trade which result from the differing require- ments in the Member States as to the ingredients of the products. Similarly, the way in which provisions regarding such notices are interpreted can also hamper 22. In other words, the warnings relating to intra-Community trade and exports to products containing diaminophenol or third countries if comprehensive warnings resorcinol, with which this case is con- have to be reproduced in the language of a cerned, are therefore directed as much at particular country in full on the packaging non-professional users of such products as and the container, and abbreviated infor- at hairdressers. The shelves of department mation, such as that used in this case ('For stores contain numerous hair colourings commercial use only. Important: follow aimed at the general public, the packaging instructions for use and heed warnings'), of which displays in one, two, three or four in different languages, is considered inade- languages the warnings in question. quate. Facilitating movement within the Community is an important consideration in the light of Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC). It may justify the view — to which the referring court is inclined — that the abbreviated information ought to be considered sufficient in the circum- stances of this case, especially since the IV — The queries of the referring court consumer can — and is invited so to do — and the observations of Schwarzkopf consult an accompanying leaflet, and the hair colourings made by the defendant are ultimately only intended for professional use (by hairdressers and others), even though it is not impossible that they might find their way to consumers directly. 23. After stating the reasons why the Ger- According to the Bundesgerichtshof, man appeal court adopted a strict inter- Schwarzkopf rightly points out that both pretation of the term 'practical reasons', professional users and consumers are which was also supported by the German accustomed, from using pharmaceutical legal writers, the Bundesgerichtshof never- products, to referring to enclosed leaflets theless asks whether it should uphold that
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for further warnings. The referring court users. It is not, however, possible to bring concludes that the type of statement made about that objective by including the full in this case should be sufficient to meet the text of the mandatory warnings, in nine requirements for the protection of health. languages, on the packaging and container without resorting to a packaging which was deceptive in appearance, because dispro- portionate to the size of the contents.
26. Schwarzkopf submits that it is neces- sary to weigh the interests at stake in order to determine whether the aim of protection, 24. Schwarzkopf submits that the provi- to which the directive in question is direc- sion in question should be interpreted as ted, is best served by the existence of meaning that the obligation in issue should abbreviated warnings in several European be mitigated, not only in those cases where languages together with full warnings on an it is objectively impossible to display the accompanying leaflet, or by the inclusion of full wording of the prescribed warnings on the full text of the warning on the packa- the packaging and containers, but in all ging and container in the language of the cases where there are 'practical reasons' for country of distribution. In this regard, it so doing. should be borne in mind that the products are intended exclusively for professional use, that is, by specialists who are on notice as to the risks involved.
V — Assessment 25. In this case, Schwarzkopf claims that such practical reasons reside in the wish to create a uniform get-up of the range of products, with identical accompanying 1. What is meant by 'not possible for leaflets, allowing European-wide market- practical reasons' or 'impossible for prac- ing, and in the benefits which accompany tical reasons'? that. These advantages are economic in nature in that they result in savings in distribution, greater competition or adap- tation to the increasing internationalisation of trade, but they also bring about increased protection against possible health 27. Community law terms are to be inter- risks for both consumers and professional preted by the Court in order to ensure
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their uniform application in all Member for practical reasons') and the Danish, 13 States. Spanish, 14 Finnish, 15 Greek 16 and Dutch 17 language versions, the expression 'not possible' is replaced by 'impossible', these two expressions are, to my mind, equivalent. 28. In Stauder, 12 the Court held, in con- nection with a decision addressed to all the Member States, that 'the necessity for uniform application and accordingly for uniform interpretation makes it impossible 32. The French language version, together to consider one version of the text in with the Italian 18 and Portuguese 19 ver- isolation, but requires that it be interpreted sions, uses the expression 'en cas d'impos- on the basis of both the real intention of its sibilité pratique'. That may, at first sight, author and the aim he seeks to achieve, in appear to be a little stronger, but there is no the light, in particular, of the versions in all difference in fact between the adjective [official] languages'. 'impossible' and the noun 'impossibility'.
29. In this case, I take the view that there 33. In fact, the differences concern more are no differences between the various what is meant by 'practical'. The question language versions of Article 6(1)(d). is whether the requirement to include the warning in full is only to be relaxed where it is 'objectively' impossible to reproduce the full text, because of insufficient space, or, as Schwarzkopf contends, also in all cases where there are sufficient practical 30. In the German language version, it is reasons, including those of an economic 'practical reasons' which render the full nature, for so doing. 20 inclusion of the warning 'not possible' ('ist dies aus praktischen Gründen nicht möglich'). The Swedish language version may be similarly translated as 'when that cannot be done for practical reasons' ('Om detta är ogörligt av praktiska skäl'). 34. The ZBUW, the French, Netherlands and Finnish Governments, and the Com-
13 — Hvis dette i praksis er umuligt. 1 4— Cuando esto fuera imposible en la práctica. 15 — Jos tama on käytännön svista mahdotonta. 31. Whilst it is true that the English 16 — Se penptosi pou, affo ine praktika adynato. language version ('where this is impossible 17 — Wanneer dit in de praktijk onmogelijk is. 18 — In caso di impossibilita pratica. 19 — Em caso de impossibilidade prática. 20 — The referring court uses the term 'renunciation' ('Ver- 12 — Case 29/69 11969] UCU 419. paragraph i. zicht').
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mission submit, in essence, that since the than that resulting from the application of warning is intended to protect public the provisions of the Directive. The same health, any derogation from the obligation conclusion may be reached from an assess- to set it out in full must be interpreted ment of the interests involved. Public health strictly. must be protected as a matter of priority and the term 'practical reasons' should be understood in the light of considerations relating to its production.
35. The ZBUW goes on to explain that what is meant by that is that recourse to the derogation is only possible where the 38. I, too, propose to the Court that the manufacturer faces 'obstacles which, for term in question be interpreted as meaning technical reasons, render it impossible to 'material impossibility'. include appropriate information on the container, such as the reduced size of the container or technical difficulties in dis- playing information on the container in indelible, easily legible and visible letter- ing', even if the 'impossibility' is not total. 39. I will examine in due course whether that interpretation must be regarded as incompatible with Article 30 of the Treaty, because it would require undertakings to produce different packaging for each Mem- ber State for which the goods are intended. 36. The Netherlands Government contends that the 'practical impossibility' of comply- ing with the warning obligation must relate to the shape or volume of the product in question, having regard to its nature, function, or usual get-up. 40. The first reason which leads me to share the view of ZBUW, the three Govern- ments and the Commission is the fact that the expressions 'not possible', 'impossible' or 'impossibility' are used by reference to a factual situation over which the party relying on it has no control, or which do 37. The ZBUW adds, in common with the not depend upon that party's intention. Commission, and the Finnish and Nether- lands Governments, that purely economic considerations are insufficient to justify recourse to the derogation. The same is true as regards reasons of expediency, convenience or relating to the wishes of 41. Second, it should be observed that, if the manufacturer or distributor, who natu- the Council had intended also to include rally prefer a situation which is simpler, economic reasons, it would have been easy more practical, easier or more economical for it to make specific provision for this in
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the text by stating: 'Where this is impos- appear on a notice in immediate proximity sible for practical reasons or for reasons of to the container in which the cosmetic economy in the manufacture of the packa- product is exposed for sale.' ging or containers...'.
42. Conversely, however, one could equally 44. However, as the Commission has contend that, if the Council had only pointed out, the difference between the intended to include practical reasons result- wording of those subparagraphs and that ing from the size or shape of the product, it of subparagraph (d) provides the basis for could have made this clear, as it did in other an argument by way of converse inference passages of Article 6, inserted in 1993. just as much as it does for an argument by analogy. If the Community legislature has not defined what is meant by 'impossible for practical reasons' within the meaning of subparagraph (d), it is just as likely that it may have deliberately omitted, rather than 43. At the end of paragraph 1, the two have forgotten, to do so. following subparagraphs have been added:
'Where it is impracticable, for reasons of 45. I therefore agree with the Commission's size or shape, 21 for the particulars referred submission that 'the last — and most to in points (d) and (g) to appear in an important — aspect in the light of which enclosed leaflet, those particulars shall the provision in question must be viewed is appear on a label, tape or card which determinative: the purpose of the legisla- is enclosed or attached to the cosmetic tion of which it forms part'. product.
In the case of soap, bath balls and other small products where it is impracticable, for reasons of size or shape, for the 2. The purpose of the Directive particulars referred to in point (g) 22 to appear on a label, tag, tape or card or in an enclosed leaflet, 23 those particulars shall 46. In my opinion, the argument that the 21 — Emphasis added. Directive is designed only secondarily to 22 — Paragraph (g) refers to the list of ingredients. It includes an assure the protection of the health of users identical derogation to that in paragraph (d) in issue in this case. of the products in question is unsustain- 23 — Emphasis added. able.
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47. In terms of its logic, the approach observed as regards the composition, label followed by the Council seems to have ling and packaging of cosmetic products been as follows: (fourth recital).
48. First, it established that there was a barrier to free movement of the products in 52. The Council drew from this the logical question because the Member States had conclusion, in Article 7(1), that 'Member adopted divergent provisions governing the States may not, for reasons related to the composition and labelling of cosmetics requirements laid down in this Directive products (first and second recitals in the and the Annexes thereto, refuse, prohibit or preamble to the Directive). restrict the marketing of any cosmetic products which comply with the require ments of this Directive and the Annexes thereto'.
49. The Council was aware that it could not invoke the Cassis de Dijon 24 decision against those divergent provisions because the Member States were entitled to rely on 53. In parallel with this, the Council pro the Article 36 proviso which permits vided in Article 3 of the Directive that restrictions on imports justified on grounds 'Member States shall take all necessary of public health to be maintained. measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market'.
50. That is apparent from the third recital, which states that 'the main objective of these laws is the safeguarding of public health and..., as a result, the pursuit of the same objective must inspire Community 54. As has already been seen, the same rule legislation in this sector'. is specifically repeated in Article 6(1), in respect of the information which must appear on the container and packaging.
51. The Council therefore determined at Community level the rules which must be 55. Those rules apply even where a product 24 — Case 120/78 Rewe-Zentral [1979] ECR 649, referred to as is marketed only in the Member State of 'Cassis de Diįon'. manufacture.
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56. Furthermore, it should be noted that 59. It is therefore absolutely undeniable the Directive does not apply to all products that the safeguarding of public health is the without exception. The Council has exclu- essential objective of the directive. The ded from its scope 'cosmetic products Commission, for its part, has confirmed containing one of the substances listed in this in the first recital of the most recent Annex V'. With regard to those products, directive amending Directive 76/768, 26 'Member States may take such measures as where it states that 'the main objective of they deem necessary' (Article 1(3), inserted Directive 76/768/EEC is to protect public by Directive 88/667). Those measures may health'. clearly extend to prohibiting the sale of these products.
60. It is therefore undeniable that, where there is a conflict between the principles of the free movement of cosmetic products and the concerns relating to the safeguard- ing of public health, it is the latter which 57. Lastly, Article 12 provides that 'if a must take precedence. Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the directive, 25 represents a hazard to health, it may provisionally 61. It is also clear, that, given the pre- prohibit the marketing of that product in its eminence accorded, within the framework territory or subject it to special conditions'. of this directive, to the concern to safe- guard public health, the expressions 'where this is impossible for practical reasons' or 'where that is not possible for practical reasons' must be interpreted narrowly. They can only refer to those cases where the full inclusion of the warning on the packaging and the container is materially 58. The Commission must then enter into impossible. consultation, issue an opinion and take the appropriate steps. 'If the Commission is of the opinion that technical amendments to the directive are necessary, such amend- ments shall be adopted by either the 62. I would add, lastly, that Schwarzkopf's Commission or the Council in accordance argument presenting the legislation in ques- with the procedure laid down in Article 10. tion as a barrier to the free movement of In that event, the Member State which has goods is, to say the least, paradoxical. As I adopted safeguard measures may maintain have shown, the free movement of cosmetic them until entry into force of the adapta- tions.' 26 — That is. Commission Directive 97/18/EC of 17 April 1997 postponing the date alter which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic 25 — Emphasis added. products (OJ 1997 L 114, p. 43).
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products was made possible only through health and consumer protection because the adoption of certain common rules, and the system it has adopted results, through it seems, therefore, scarcely conceivable the inclusion of abbreviated warnings in that a manufacturer should now wish to several languages, in equivalent, if not free itself from them by arguing that one of better, protection for consumers and pro- them constitutes a barrier to intra-Com- fessional users. munity trade.
63. On the other hand, the Court has held, in the Clinique27 case, that the Directive 66. Schwarzkopf claims, first, that this must, 'like all secondary legislation, be system makes it possible to give informa- interpreted in the light of the Treaty rules tion also to foreigners resident in the on the free movement of goods (see, in country of distribution who are not fluent particular, the judgment in Case C-47/90 in the language of that country. To that the Delhaize and Le Lion v Promalvin and Commission replies, rightly in my view, AGE Bodegas Unidas [1992] ECR I-3669, that the abbreviated warning would also paragraph 26)'. have to appear in the Turkish language, given that the Federal Republic of Germany has a sizeable resident population of Turk- ish mother tongue. Moreover, that argu- ment in no way justifies the conclusion that the double inclusion of the full warning 64. Certain of the arguments put forward required by the Directive is not necessary by Schwarzkopf amount, in essence, to for the attainment of, or that it is dispro- maintaining that the rule in issue consti- portionate to, the objective pursued. tutes a hindrance to free trade which is unnecessary for the attainment of the objective pursued.
67. The Council clearly intended that the 3. Is the rule in question disproportionate? warning be such as to 'catch the eye' of users, first, picking up the box and, second, on taking hold of the tube. It may thus be assumed that the Council had in mind that certain people will not tend to read a leaflet, even when they are referred to it. 65. Schwarzkopf submits that the rule The Finnish Government also added, cannot be justified on the ground of public rightly, that not all of the containers are intended to be used once only, and the leaflet could become lost after the product 27 — Case C-315/92 Verband Sozialer Wettbewerb 'Clinique' [1994] ECR I-317, paragraph 12. is first used.
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68. Schwarzkopf nevertheless submits that various external parts of the human body the system that it has adopted ensures a (epidermis, hair system, nails, lips and protection equivalent to that provided by external genital organs) or with the teeth the inclusion of a full warning on the and the mucous membranes of the oral packaging and containers, since the con- cavity with a view exclusively or mainly to sumer and the professional user are accus- cleaning them, perfuming them, changing tomed, from their experience of using their appearance and/or correcting body medicines, to read the enclosed leaflet. odours and/or protecting them or keeping them in good condition'.
69. The ZBUW rightly objects, however, that, according to the Directive, cosmetic 71. Cosmetics are therefore readily distin- products must not be harmful to human guishable from medicines, which are health when they are applied under normal defined as being 30 'any substance or com- or foreseeable conditions of use, 28 and bination of substances presented for treat- therefore, consumers and professional users ing or preventing disease in human beings cannot be expected to be as careful in their or animals. Any substance or combination use of cosmetic products as they are in the of substances which may be administered use of medicines. to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological func- tions in human beings or in animals is likewise considered a medicinal product'.
70. For my part, I agree that consumers and professional users cannot be required to exercise the same degree of caution in the handling of cosmetic products as of medicines, since they do not expect cos- 72. The average consumer is well aware metic products to be harmful to health. The that some medicines can have side effects, Directive defines cosmetic products as and will therefore be more likely to refer to being 29 'any substance or preparation the conditions for use on the enclosed intended to be placed in contact with the leaflet. Nor should we forget that most medicines are prescribed by doctors, who will already have explained to the patient 28 — Sec Article 2( I ) of the Directive, which states 'A cosmetic the proper dosage and drawn his attention product put on the market within the Community must not cause damage to human health when applied under normal to any possible side effects. or reasonably foreseeable conditions or use, taking account, in particular, tit the product's presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the 30 — See Article 1(2) of Council Directive 65/65/EEC of manufacturer or his authorised agent or by any other 26 Januarv 1965 on the approximation of provisions laid person responsible for placing the product on the Com- down by law, regulation or administrative action relating munity market'. to proprietarv medicinal products (OJ, English Special 29 — See Article 1 (1)(1) of the Directive. Edition, First Series 1965-1966. p. 24).
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73. It is not, therefore, appropriate to — a special warning, if necessary, for the compare the behaviour of consumers in medicinal product concerned; the use of medicines with their behaviour in the use of cosmetic products, because the latter are supposed to be harmless.
— special storage precautions, if any;
74. In any case, it should be noted that Council Directive 92/27/EEC of 31 March 1992 concerning the labelling of medicinal — special precautions for disposal of products for human use and on package unused medicinal products or waste leaflets,31 also requires the appending of materials derived from such products, certain warnings on the packaging, without if appropriate; any possibility of referring, in this regard, to the leaflet which, for its part, must contain other information.
— in the case of self-medication, instruc- tions on the use of the medicinal products. 75. Thus packaging must bear the name of the medicinal product, a statement of the active ingredients expressed qualitatively and quantitatively per dosage unit, a list of those excipients known to have a recog- 76. It is evident that this information will nised action or effect, as well as: in practice never be able to be included on a single package in all of the languages of the Member States.
— the method and, if necessary, the route of administration; 77. As regards cosmetic products, it is also necessary to bear in mind, as the Finnish and Netherlands Governments point out, that the Community legislature has clearly accorded to the appending of the full wording of the warnings set out in the — a special warning that the medicinal Annexes to the Directive on the packaging product must be stored out of reach of and the container of a cosmetic product in children; the national or official language, or lan- guages, of the country of distribution a greater protective effect for the average 31 —OJ 1992 L 113, p. 8. cosumer and professional user than to the
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appending of an abbreviated warning with consumer and providing the consumer with a reference to an enclosed leaflet. information...' 32 and that 'it follows from the foregoing that under Community law concerning consumer protection the provi- sion of information to the consumer is considered one of the principal require- ments...'. 33 78. The French and Netherlands Govern- ments submit, also rightly, that the consu- mer must be able to inform himself of any precautions to be taken before buying a cosmetic product, and therefore without 81. It remains to consider whether a opening the packaging, in order to be able requirement, which is not disproportionate to choose with full knowledge of the facts. when it concerns products intended for use by the general public, becomes so when it concerns products specifically intended for professional use.
79. It is important not to lose sight of the fact that the cosmetic products covered by the Directive are intended for the general public. It is absolutely essential that a consumer who wishes to purchase, for 4. The particular case of professional users example, some talcum powder, is told, before buying, that a talcum powder con- taining boric acid should not be used for babies (see Annex III, part 1, No 1 to the 82. Schwarzkopf submits that account Directive), or that another such product must be taken, when weighing the interests may cause blindness (No 17 in the same at stake, of the fact that the product at issue annex). is intended exclusively for professional users, for whom the same degree of protec- tion as that required for the average consumer is not necessary.
80. The quality of the information consti- tutes a key element in consumer protection. 83. To this, the Finnish Government replies The Court has stated that: that the Directive is intended to safeguard the health of professional users just as much as that of consumers, and that the fact that a product is intended exclusively
32 — Case C-362/88 CB-lmm-BM [1990] ECR I-667, para- '... Community policy on the subject estab- graph 14. lishes a close link between protecting the 33 — GB-Inno-BM, cited above, paragraph 18.
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for professional use cannot be used as a Whilst some of these products do not give pretext for applying to those users a less rise special problems, it is evident that rigorous provision. It adds that profession- repeated application several times a day als face even greater health risks, and also may cause problems of irritation and users that it cannot be discounted that the should therefore be put in a position to product will fall into the hands of ordinary avoid these problems'. consumers.
85. If a committee within which the views of both businesses and workers are expressed comes to the conclusion that the information prescribed by the Directive would be improved by the addition of material intended for professionals, it can hardly be said that the legislature has 84. It should be recalled, in this regard, infringed the principle of proportionality that, until the adoption of Directive in not authorising recourse to more suc- 88/667, Article 6(1)(d) made no mention cinct information for professionals than for of a requirement to append to the packa- ordinary consumers. ging and container warnings addressed specifically to professional users. It was only as a result of the observations of the Economic and Social Committee that the phrase 'as well as any special precautionary information on cosmetic products for pro- fessional use, in particular in hairdressing' 86. Whilst professionals with a long experi- was inserted into Article 6(1)(d) of the ence are probably aware of the precautions Directive. The Committee had stated, at to be taken, the same is not necessarily true paragraph 2.3, of its opinion on the draft for apprentices. Furthermore, it may be directive, 34 that '[t]he Committee expresses that new product marks or commercial its concern over the failure to mention names will begin to be used without the special precautions to be taken in the case employees being immediately aware that of cosmetic products for professional use, they pose the same possible risks as those in particular by hairdressers. Some infor- with which they are familiar. mation on this matter, intended for all users, is admittedly set out in Annex III. Manufacturers should, however, be required to indicate — at all events in the case of some products — that it is advisa- ble to wear gloves when applying them. 87. It would, admittedly, be conceivable that, for products intended exclusively for professional use, a briefer warning would 34 — Opinion of the Economic and Social Committee on the proposal for a Council Directive amending for the fourth suffice, emphasising the essential points time Directive 76/768 on the approximation of the laws of the Memher States relating to cosmetic products (OJ 1987 such as 'Warning: harmful to the eyes; risk C 319, p. 5). of allergy; read the leaflet carefully'.
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88. However, it is not because the Com- converse situation, that is, in the case of munity legislature has not taken that route circumscribed powers, that all choice dis- that it is possible to criticise it for having appears and a number of lawful solutions infringed the principle of proportionality. cannot exist simultaneously. Differentiating between labelling obliga- tions according to the distribution cir- cuit — public at large or circuit reserved to professionals — or, by contrast, unify- ing labelling obligations, with alignment on the need to protect the averagely well- informed consumer, are two options between which the Community legislature, 5. Article 30 and the multiplicity of lan- because it enjoys an undeniable discretion, guages was entitled to make a choice. And it is not because that choice does not satisfy a manufacturer that the measures adopted are unlawful. They would be so only if it were proved that, in requiring the append- 90. It remains for me to comment briefly ing on products intended for professionals on the argument that the fact of preventing of the same information as that to be a manufacturer of cosmetic products from appended on the products as for the general using a single packaging and container for public, the Community legislature had, as a all of the Member States of the Community result of a manifest error of assessment, constitutes a restriction of the principle of placed a disproportionate burden upon the free movement of goods, contrary to manufacturers with regard to the objective Article 30 and 34 of the EC Treaty (now, of safeguarding public health pursued by it after amendment, Article 29 EC). and which it was entitled to pursue. No such proof has been adduced before the Court.
91. Let us acknowledge that, if it were possible to satisfy the requirements of the protection of public health and to use one form of packaging for the whole of the Community market, then we would have an ideal situation.
89. Nor, if tomorrow the legislature were to make a different choice, would that choice be open to objection, provided that the measures adopted respected the princi- ple of proportionality; nor would that 92. However, there can be a gap between mean that the choice it had made pre- the ideal and the attainable. The inescap- viously was erroneous. The existence of a able reality of the Community is that of the discretion means, by definition, that differ- coexistence, within the same market, of a ent solutions, all perfectly lawful, are open large number of different national and to the decision-maker. It is only in the official languages.
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93. The costs which flow from that fact are 96. It may be noted in passing that it is not imposed by the Council, but result from materially possible to print the warning, in the nature of things. They cannot, there- three languages, on the tube and corre- fore, be regarded as an unlawful restriction sponding packaging. Availing itself of this on trade contrary to Article 30 of the possibility, 36 a manufacture will need only Treaty. four types of packaging to cover the 15 Member States, and, at the same time, in so far as the relevant labelling obligations there are comparable, all of the English-, French-, Spanish- and Portuguese-speaking countries of the world (plus, possibly, the Arabic-speaking countries, since there are only 11 Community languages, and so one of the packs could cover two Community 94. The need to print different packages is languages plus Arabic). not, moreover, the equivalent of the 'varia- tion in production' which the Directive sought to avoid (second recital in the preamble). That variation refers to the composition of the products. As for the economic necessities which are required to be taken into account under the third recital in the preamble, we have seen that, 97. I would point out moreover that the in case of conflict, they cannot prevail over burden of linguistic constraints has made the necessities relating to the protection of itself felt on another level. The Directive public health. provides, in Article 7a, that a series of seven sets of data is made available to the competent authorities in other Member States in the official language or languages of the Member State concerned, or in a language readily understood by them.
95. It is, therefore, right that the Commu- nity legislature has provided in Article 7(2) that the Member States 'may require that the particulars provided for in Arti- cle 6(1)(b), (c) and (d) be expressed at least 98. These include the qualitative and quan- in their own national or official language or titative composition of the product, the languages'. 35
36 — I have before me a hair colouring reserved for professional 35 — Directive 93/35 has replaced this subparagraph with the use, sold under the name 'Majirel HT'. It carries the following: following warning in French, English and Spanish on the 'They may, however, require that the particulars provided cardboard packaging aud ott the tube: 'Contains: Diami- for in Article 6(1)(b), (c), (d) and (f) be expressed at least in nophenol, resorcinol and ammonia. Wear appropriate their own national or official language or languages; they gloves, preferably single-use. Rinse well after applying. may also require that the particulars provided for in May cause an allergic reaction. Sensitivity testing (touch Article 6(1)(g) be expressed in a language easily under- test): see leaflet. Rinse immediately if the product comes stood by the consumer. To that end, the Commission shall into contact with the eyes. Follow the instruction leaflet'. adopt a common ingredients nomenclature in accordance This tube contains 50 ml whilst Schwarzkopf's contains 60 with the Article 10 procedure.' ml.
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method of manufacture, an assessment of 100. I would add that if one were to take the safety for human health of the finished the argument of impermissible costs to its product, existing data on undesirable logical conclusion, one would be forced to effects on human health, and proof of the conclude that the Council should abandon effect by the cosmetic product. the requirement to print warnings not only on the packaging and containers of cos- metic products, but also on those of medicines and phytosanitary products, whenever the length of the warning would prevent its being printed in all of the Community languages, at least where the 99. That shows, once again, that the Com- products are intended for professionals. munity legislature intended to accord first priority to the protection of human health. It clearly considers that if a manufacturer wishes to market his products in other Member States he must bow to the con- 101. Having regard to the importance to be straints arising from the multiplicity of attached to the protection of public health, languages in the Community. such an argument clearly cannot succeed.
VI — Conclusion
102. In the light of all the foregoing considerations, I propose that the Court rule as follows:
The term 'impossible for practical reasons' in the second sentence of Article 6(1)(d) of Council Directive 76/768/EEC on the approximation of the
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laws of the Member States relating to cosmetic products, in conjunction with Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 and 30 EC), must be interpreted as meaning that it does not permit the full wording of the warning not to be given merely because the undertaking considers it appropriate, for economic reasons, to market its products in a uniform get-up in nine languages in different States, furnishing only abbreviated information on the packaging and container, so long as it is materially possible to print the full information.
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