Judgment of the Court of 25 January 1994. - Angelopharm GmbH v Freie Hansestadt Hamburg. - Reference for a preliminary ruling: Verwaltungsgericht Hamburg - Germany. - Cosmetic products - Validity fo the addition of a substance to the list of substances which must not form part of the composition of cosmetic products. - Case C-212/91.



European Court reports 1994 Page I-00171



Summary

Parties

Grounds

Decision on costs

Operative part



Keywords

++++

Approximation of laws - Cosmetic products - Directive 76/768 - List of substances which may not be used - Amendment procedure - Mandatory consultation of the Scientific Committee - Addition by Directive 90/121, in a manner contrary to that procedural requirement, of the substance 11 alpha OHP - Substantial defect - Invalidity of the provision in question

(Council Directive 76/768, Art. 8(2); Commission Directive 90/121, Art. 1)

Summary

Article 8(2) of Directive 76/768 on the approximation of the laws of the Member States relating to cosmetic products, as amended, provides that the amendments necessary for adapting Annexes II to VII of that directive to technical progress, and more particularly Annex II listing substances the use of which is prohibited, are to be adopted after consultation of the Scientific Committee for Cosmetology at the initiative of the Commission or of a Member State. While it is not clear from the wording of that provision in the different language versions and a comparison of those versions whether that Committee has to be consulted in all cases, it follows from an examination of the Committee' s role in the procedure in question that such consultation is mandatory in all cases in so far as it is designed to ensure that the measures adopted at Community level are necessary and adapted to the objective of protecting human health pursued by the directive.

Since the failure to consult the Scientific Committee on the question of the prohibition of 11 alpha OHP by the Twelfth Directive 90/121 adapting to technical progress Annexes II, III, IV, V and VI to Directive 76/768 constituted a substantial defect vitiating the procedure for the adoption of the Twelfth Directive, the provisions of Article 1 of that directive are invalid in so far as they add 11 alpha OHP and its esters to the "list of substances which must not form part of the composition of cosmetic products" appearing in Annex II to Directive 76/768.

Parties

In Case C-212/91,

REFERENCE to the Court under Article 177 of the EEC Treaty by the Verwaltungsgericht (Administrative Court) Hamburg (Federal Republic of Germany) for a preliminary ruling in the proceedings pending before that court between

Angelopharm GmbH

and

Freie und Hansestadt Hamburg

on the question whether a national court is prevented from regarding as invalid or void a national regulation which consists only of provisions implementing a directive within the meaning of the third paragraph of Article 189 of the EEC Treaty, on the question whether, if this is not the case, the directive is then to be regarded as having direct effect, and, thirdly, on the question whether, if the answer to either of the two preceding questions is in the affirmative, Article 1 of the Twelfth Commission Directive (90/121/EEC) of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1990 L 71, p. 40) is valid in so far as it adds 11 *-Hydroxypregn-4-ene-3,20-dione and its esters to Annex II to the latter directive ("List of substances which must not form part of the composition of cosmetic products"),

THE COURT,

composed of: O. Due, President, J.C. Moitinho de Almeida and D.A.O. Edward (Presidents of Chambers), R. Joliet, F.A. Schockweiler, G.C. Rodríguez Iglesias, F. Grévisse (Rapporteur), P.J.G. Kapteyn and J.L. Murray, Judges,

Advocate General: F.G. Jacobs,

Registrar: L. Hewlett, Administrator,

after considering the written observations submitted on behalf of:

- Angelopharm GmbH, the plaintiff in the main proceedings, by Eberhard Millarg, Rechtsanwalt, Hamburg,

- the German Government, by Ernst Roeder, Ministerialrat at the Federal Ministry of the Economy, and Joachim Karl, Regierungsdirektor at the Federal Ministry of the Economy, acting as Agents,

- the United Kingdom, by John Collins, Assistant Treasury Solicitor, acting as Agent, assisted by Alan F. Rodger QC, Solicitor General for Scotland, and Christopher Vajda, Barrister,

- the Commission of the European Communities, by Rolf Waegenbaur, Legal Adviser, acting as Agent, assisted by Barbara Rapp-Jung, of the Brussels Bar,

having regard to the Report for the Hearing,

after hearing the oral observations of Angelopharm GmbH, the United Kingdom and the Commission at the hearing on 11 May 1993,

after hearing the Opinion of the Advocate General at the sitting on 16 June 1993,

gives the following

Judgment

Grounds

1 By order of 6 June 1991, which was received at the Court on 9 August 1991, the Verwaltungsgericht (Administrative Court) Hamburg referred three questions to the Court under Article 177 of the EEC Treaty. The first is whether a national court is prevented from regarding as invalid or void a national regulation which consists only of provisions implementing a directive within the meaning of the third paragraph of Article 189 of the EEC Treaty, the second whether, if this is not the case, the directive is then to be regarded as having direct effect, and the third whether, if the answer to either of the two preceding questions is in the affirmative, Article 1 of the Twelfth Commission Directive (90/121/EEC) of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1990 L 71, p. 40) ("the Twelfth Directive") is valid in so far as it adds 11 *-Hydroxypregn-4-ene-3,20-dione ("11 alpha OHP") and its esters to Annex II to the latter directive ("List of substances which must not form part of the composition of cosmetic products").

2 Those questions were referred in the course of proceedings between Angelopharm GmbH ("Angelopharm") and the Freie und Hansestadt Hamburg (Free and Hanseatic City of Hamburg) concerning the right of Angelopharm to manufacture and market a product known as Setaderm.

3 Setaderm is a product designed to prevent genetically-conditioned androgenic hair-loss. It contains 11 alpha OHP. According to a judgment of the Oberverwaltungsgericht (Higher Administrative Court) Hamburg of 2 December 1986 (OVG Bf VI 38/85), Setaderm is a cosmetic product.

4 Angelopharm has manufactured and marketed Setaderm since January 1983. Following an opinion of the Bundesgesundheitsamt (Federal Health Bureau) of 28 August 1984 to the effect that 11 alpha OHP and its esters had an effect on male hormonal activity and could for that reason be injurious to health, the use of 11 alpha OHP in the manufacture of cosmetic products was banned in the Federal Republic of Germany by Article 1 of the Ninth Regulation of 20 March 1985 amending the Cosmetics Regulation (Neunte Verordnung zur AEnderung der Kosmetik-Verordnung, Bundesgesetzblatt (BGBl) (Federal Official Journal) I, p. 586) of 20 March 1985. The first subparagraph of Article 6(a) of that Regulation, as amended, provided that the manufacture of products containing 11 alpha OHP was to be permitted until 31 December 1986 and the marketing of such products until 31 December 1987.

5 In accordance with those provisions, Angelopharm ceased marketing Setaderm after 31 December 1987. However, it instituted proceedings before the Verwaltungsgericht Hamburg for a declaration that it could lawfully manufacture and market Setaderm after that date.

6 Angelopharm essentially argued before the national court that 11 alpha OHP was not injurious to human health and that its use in the manufacture of cosmetic products could not be prohibited.

7 On 8 February 1990 the Verwaltungsgericht Hamburg commissioned an expert' s report for the purpose of determining the effects of 11 alpha OHP on human health.

8 The expert appointed by the Verwaltungsgericht Hamburg delivered his report on 12 October 1990. In his opinion, 11 alpha OHP did not constitute a danger to human health but did not have any demonstrable effect on hair growth.

9 In the meantime, the use of 11 alpha OHP and its esters in the manufacture of cosmetic products had been prohibited by the Twelfth Directive, cited above. Article 2 of that directive provided that the placing on the market of products containing that substance was to be prohibited from 1 January 1991 and that sale or disposal to the final consumer was to be prohibited with effect from 31 December 1991.

10 The Twelfth Directive was implemented in the Federal Republic of Germany by the Seventeenth Regulation of 21 March 1990 amending the Cosmetics Regulation (Siebzehnte Verordnung zur AEnderung der Kosmetik-Verordnung (BGBl I, p. 589)).

11 Being, in its own words, convinced by the findings of the expert whom it had appointed, the national court took the view that the German legislation was contrary to the combined provisions of Paragraphs 26 and 32 of the Lebensmittel- und Bedarfsgegenstaendegesetz (Law on Foodstuffs and Essential Goods) of 15 August 1974 (BGBl I, p. 1945) in so far as it prohibited the use of 11 alpha OHG in the manufacture of cosmetic products.

12 That court was, however, uncertain whether it could declare the German legislation invalid on this point since the provisions of the Twelfth Directive containing the same prohibition would thereby have been rendered ineffective in national law.

13 In those circumstances, the Verwaltungsgericht Hamburg stayed the proceedings and referred the following questions to the Court for a preliminary ruling:

"1. Is the national court prevented from regarding a national regulation as invalid or void if, and in so far as, it consists only of provisions implementing a directive within the meaning of the third paragraph of Article 189 of the EEC Treaty?

2. If not, does a directive under the third paragraph of Article 189 of the EEC Treaty then have direct effect?

3. If the answer to either of the above questions is affirmative, is the prohibition of 11 *-Hydroxypregn-4-ene-3,20-dione and its esters under the Twelfth Commission Directive (90/121/EEC) of 20 February 1990 valid?"

14 Although the questions in the present case relate to a product classified by the national court as a "cosmetic product", it should be pointed out that in Case C-112/89 The Upjohn Company and Upjohn NV v Farzoo Inc. and J.A.W.M.J. Kortmann [1991] ECR I-1703 questions were referred to the Court on the issue of whether a product designed to combat natural baldness, like Setaderm, was to be regarded as a "medicinal product" within the meaning of Council Directive 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 (Official Journal, English Special Edition 1965-1966, p. 20) or as a "cosmetic product" within the meaning of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1976 L 262, p. 169) ("the Cosmetics Directive").

15 In its judgment in Upjohn, the Court ruled (at paragraphs 21 to 23) that the definition of a "medicinal product" within the meaning of Directive 65/65, cited above, included all substances capable of having an effect on the actual functioning of the body but did not, however, include substances such as certain cosmetics which, while having an effect on the human body, did not significantly affect the metabolism and thus did not strictly modify the way in which it functioned. The Court stated that it was for national courts to determine on a case-by-case basis the classification of each product having regard to its pharmacological properties as they might be ascertained in the current state of scientific knowledge, to the way in which it was used, to the extent to which it was sold and to consumers' familiarity with it. The Court also pointed out in that judgment (at paragraph 33) that any product satisfying the definition of a "medicinal product" laid down in Article 1(2) of Directive 65/65 had to be subject to the corresponding legal rules, to the exclusion of those governing cosmetic products.

16 It is subject to those observations, whose relevance and effect must be assessed by the national court in the main proceedings before it, that the questions referred to this Court will be examined.

17 The national court asks whether it can examine the legality of a national regulation, in this case the Seventeenth Regulation of 21 March 1990 amending the Cosmetics Regulation, which implements in national law a prohibition contained in a Community directive, namely the prohibition of 11 alpha OHP contained in the Twelfth Directive, and the provisions of which are substantially the same as those of the Directive.

18 The first and second questions referred by the Verwaltungsgericht Hamburg serve a purpose in the main proceedings only if the relevant provisions of the Directive are valid. If they are invalid and consequently not applicable in the main proceedings, the provisions of a Community directive cannot prevent a national court from examining whether the national regulation can be applied. The first matter to be considered is therefore whether, as the national court asks in its third question, Article 1 of the Twelfth Directive adding 11 alpha OHP and its esters to the "list of substances which must not form part of the composition of cosmetic products" appearing in Annex II to Directive 76/768, cited above, as amended, is valid, and then the consequences to be attached, for the purpose of resolving the dispute before the national court, to the existence of a valid directive which is substantially the same as the national regulation, which are the subject of the national court' s first and second questions.

The validity of the Directive

19 Angelopharm argues that the provisions of the Twelfth Directive which relate to 11 alpha OHP must be declared invalid on the ground that they infringe essential procedural requirements and rules of Community law.

20 On the first point, Angelopharm claims in particular that the Scientific Committee on Cosmetology ("the Scientific Committee") must, under Article 8(2) of the Cosmetics Directive, be consulted on all amendments made to Annexes II to VII to the Cosmetics Directive and that it was not so consulted with regard to the addition of 11 alpha OHP and its esters to Annex II to the Directive.

21 The Commission, the German Government and the United Kingdom, however, argue that Article 8(2) of the Directive requires the Scientific Committee to be consulted only if a Member State or the Commission so requests, which was not the case here.

22 In order to assess the force of those arguments, it will be useful to recapitulate the procedure of which Article 8(2) of the Cosmetics Directive forms a part.

23 Article 9 of the Cosmetics Directive establishes a Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector (referred to as "the Committee" in the Cosmetics Directive), which consists of representatives of the Member States with a Commission representative as chairman.

24 Article 10 of the Cosmetics Directive, as amended, provides as follows:

"1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman, either on his own initiative or at the request of the representative of a Member State.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time-limit set by the chairman according to the urgency of the matter. Opinions shall be adopted by a majority of 54 votes, the votes of Member States being weighted as provided for in Article 148(2) of the Treaty. The chairman shall not vote.

3. (a) The Commission shall adopt the proposed measures when they are in accordance with the opinion of the Committee.

(b) Where the proposed measures are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.

(c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission."

25 Article 8(2) of the Cosmetics Directive, as amended, provides as follows:

"The amendments necessary for adapting Annexes II to VII to technical progress shall be adopted in accordance with the same procedure [that laid down in Article 10], after consultation of the Scientific Committee for Cosmetology at the initiative of the Commission or of a Member State".

26 From the wording of Article 8(2) of the Cosmetics Directive in the different language versions and a comparison of those versions it is not clear whether the Committee has to be consulted in all cases. The sentence structure and the words and expressions used in the different language versions of the Directive admit of two interpretations of that article. The article may be interpreted as meaning that the Scientific Committee is to be convened only if the Commission or a Member State so requests. However, the article can also be interpreted as meaning that it is for the Commission or the Member States to take the initiative to convene the Scientific Committee, which must be consulted in all cases.

27 This uncertainty as to the meaning of Article 8(2) of the Cosmetics Directive is reinforced if one compares the wording of that article with the wording of Articles 8a(3) and 10(1) of the same Directive.

28 Although they both stem from Council Directive 82/368/EEC of 17 May 1982 amending for the second time Directive 76/768/EEC (Official Journal 1982 L 167, p. 1) and although they introduce comparable decision-making procedures involving the Scientific Committee, Articles 8(2) and 8a(3) of the Cosmetics Directive do not provide for consultation of the Scientific Committee in the same terms in all the language versions of the Directive. Some versions of the two articles, such as the German and Dutch versions, do have the same wording, whereas other versions, such as the English, French and Greek versions, are worded differently. The Danish texts, taken literally, are even appreciably different: "... efter at Det videnskabelige udvalg for Kosmetologi paa foranledning af Kommissionen eller en medlemsstat har vaeret hoert ..." in the case of Article 8(2), and "... og, saafremt Kommissionen eller en medlemsstat oensker det, efter samraad med Det videnskabelige udvalg for Kosmetologi ..." in the case of Article 8a(3). Thus, even if it is accepted that consultation of the Scientific Committee may be optional in the context of Article 8a(3), it is not possible, in the absence of any precise indication in the recitals or other provisions of Directive 82/368, to say whether the Community legislature did or did not intend to confer the same meaning on the provisions of Articles 8(2) and 8a(3).

29 As for Article 10(1) of the Cosmetics Directive, that provision deals with consultation of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector established under Article 9 of that Directive. In view of the scheme of Article 10, it is clear that consultation of this Committee is mandatory. However, in defining the conditions under which the Committee is to be consulted, the Community legislature used the same words or formulas as those which it employed in Articles 8(2) and 8a(3) inasmuch as it provided for the Committee to be consulted on the "initiative" or at the "request" of the Commission representative or the representatives of the Member States.

30 In order to remove the ambiguity from the wording of Article 8(2) of the Cosmetics Directive and to determine whether consultation of the Scientific Committee is mandatory, it is therefore necessary to refer to the Committee' s role in the procedure for the adaptation of Annexes II to VII to the Cosmetics Directive.

31 As is emphasized in particular in the preambles to Directives 76/768, 82/368 and 90/121, the drafting and adaptation of Community rules governing cosmetic products are founded on scientific and technical assessments which must themselves be based on the results of the latest international research and which are frequently complex. This is particularly the case where it is a question of assessing whether or not a substance is injurious to human health.

32 As it has itself admitted before the Court, the Commission is not in a position to carry out assessments of this kind. Thus, it was not in a position to indicate the reasons why 11 alpha OHP was a dangerous substance which had to be prohibited or to evaluate the findings of the expert appointed by the Verwaltungsgericht Hamburg within the period set by the Court for that purpose, even though that period expired long after the prohibition of 11 alpha OHP by the Twelfth Directive and the submission of the expert' s report.

33 The Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector, which consists exclusively of representatives of the Member States and of the Commission, is similarly not in a position to make such an assessment. As the United Kingdom pointed out in its oral observations before the Court, that Committee must, in the nature of things and apart from any provision laid down to that effect, be assisted by experts on scientific and technical issues delegated by the Member States.

34 The Scientific Committee, however, has the task of assisting the Community authorities on scientific and technical issues in order to enable them to determine, from a fully informed position, which adaptation measures are necessary.

35 From the preamble to Commission Decision 78/45/EEC of 19 December 1977 establishing a Scientific Committee on Cosmetology (Official Journal 1978 L 13, p. 24) it is clear that the Scientific Committee, which consists of individuals who are highly qualified in disciplines relevant to cosmetology, such as medicine, toxicology, biology and chemistry, was created in order to provide the Commission with the assistance necessary to examine the complex scientific and technical problems entailed by the drafting and adaptation of Community rules on cosmetic products.

36 In the procedure before the Court the Commission accepted that consultation of this Committee in the procedure for the adaptation of the annexes to the Cosmetic Directive made it possible to ensure that the measures had a scientific basis, that they took account of the most recent scientific and technical research and that only prohibitions necessary on grounds of public health were imposed.

37 The Commission cannot successfully argue, as it did during the oral procedure, that consultation of the Scientific Committee is necessary only when authorization of the use of a substance in the manufacture of cosmetic products is envisaged. In the first place, no provision in the Cosmetics Directive makes a distinction according to whether the measure envisaged prohibits or authorizes the use of a substance. Secondly, the Commission may not, without breaching the provisions of the Cosmetics Directive, prohibit the use of a substance which, in the light of the results of the most recent scientific and technical research, cannot be regarded as dangerous.

38 Since the purpose of consulting the Scientific Committee is to ensure that the measures adopted at Community level are necessary and adapted to the objective, pursued by the Cosmetics Directive, of protecting human health, consultation of the Committee must be mandatory in all cases.

39 That interpretation is confirmed by the new version of Article 8(2) laid down in Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1993 L 151, p. 32), the provisions of which are not, however, applicable to the main proceedings. In its amended version, Article 8(2) of the Cosmetics Directive simply requires consultation of the Scientific Committee so that it is clear that this formality is mandatory. There is nothing in the preamble which even suggests that the Community legislature intended to alter the scope of Article 8(2) of the Cosmetics Directive on this essential point or, in particular, that it intended to make mandatory a formality which was not previously mandatory.

40 In reply to the written questions of the Court, the Commission indicated that, although the Scientific Committee had been consulted on the measures adopted in connection with certain substances referred to in the Twelfth Directive, it had not been consulted with regard to the prohibition of 11 alpha OHP.

41 The procedure for the adoption of the Twelfth Directive was thus vitiated by a substantial defect of such kind as to render the Directive invalid in so far as it prohibits the use of 11 alpha OHP in the manufacture of cosmetic products.

42 The reply to the third question referred to the Court must therefore be that the provisions of Article 1 of the Twelfth Directive adding 11 alpha OHP and its esters to the "list of substances which must not form part of the composition of cosmetic products" appearing in Annex II to the Cosmetics Directive are invalid.

The first and second questions

43 As stated in paragraph 18 of this judgment, the first and second questions referred to the Court serve a purpose in the main proceedings only if the Directive applied is valid.

44 In view of the reply to the third question, it is not necessary to rule on the first and second questions.

Decision on costs

Costs

45 The costs incurred by the German Government, the United Kingdom and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

Operative part

On those grounds,

THE COURT,

in answer to the questions referred to it by the Verwaltungsgericht Hamburg, by order of 6 June 1991, hereby rules:

The provisions of Article 1 of the Twelfth Commission Directive (90/121/EEC) of 20 February 1990 adapting to technical progress Annexes II, III, IV, V and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, adding 11 alpha OHP and its esters to the "list of substances which must not form part of the composition of cosmetic products", are invalid.