Important legal notice

61991C0212

European Court reports 1994 Page I-00171

Opinion of the Advocate-General

My Lords,

"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?

4. By those questions, the Verwaltungsgericht asks in substance whether a national court is obliged to enforce a prohibition laid down by Community law notwithstanding that legislation implementing the prohibition in national law would otherwise be invalid, and, if so, whether the prohibition of OHP introduced by the Twelfth Directive is itself invalid. The case thus raises the question whether national courts can declare invalid, as contrary to national law, national measures implementing directives.

5. It appears that the questions at issue in the main proceedings relate only to the Cosmetics Directive, and that no issue is raised concerning the classification of Setaderm as a cosmetic product rather than 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 medicinal products (OJ, English Special Edition 1965-1966, p. 20; hereafter "the Medicines Directive" (4)). It is clear however that a product which comes within the scope of the Medicines Directive is subject to the authorization requirements laid down pursuant to that Directive, even if it falls within the definition of cosmetic product given in the Cosmetics Directive: see Case C-60/89 Monteil and Samanni [1991] ECR I-1547, at paragraphs 15 to 17 of the judgment, and Case C-112/89 Upjohn [1991] ECR I-1703, at paragraphs 30 to 33. Thus if Setaderm were to be classified as a medicine, and had not been authorized under the Medicines Directive, the sale of Setaderm would still be prohibited even if the contested provision were held to be invalid. (5)

7. In what follows I shall first set out the relevant Community legislation and then discuss the question of the classification of Setaderm as a cosmetic or medicinal product. I will then turn to consider the questions referred.

The Community legislation

(a) The Cosmetics Directive

8. The Cosmetics Directive, which was adopted under Article 100 of the Treaty, has the aim of harmonizing national provisions which regulate the composition of cosmetic products and the rules for their labelling and packaging. According to the third recital to the Directive:

"... 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 legislation in this sector; ... however, this objective must be attained by means which also take account of economic and technological requirements".

According to the fifth recital:

"... this Directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products; ... for this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals; ...".

The term "cosmetic product" is defined in Article 1(1) of the Directive as follows:

"A 'cosmetic product' means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours."

An illustrative list of such products is contained in Annex I to the Directive; however, by Article 1(3), products containing one of the substances listed in Annex V are excluded from the scope of the Directive.

10. By Article 5, as amended, Member States are required to allow the marketing of certain products listed in Annexes III, IV, VI and VII under the conditions laid down. Article 7 provides that Member States may not, for reasons related to the requirements laid down in the Directive, refuse, prohibit or restrict the marketing of any product which complies with the requirements of the Directive.

11. Article 8 provides for the technical adaptation of the Directive. Article 8 originally provided as follows:

"1. In accordance with the procedure laid down in Article 10 the following shall be determined:

- the methods of analysis necessary for checking the composition of cosmetic products,

- the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.

However, Council Directive 82/368/EEC of 17 May 1982 (7) replaced Article 8(2) by a new version which, after further amendment, (8) is in the following terms:

"The amendments necessary for adapting Annexes II to VII to technical progress shall be adopted in accordance with the same procedure [namely 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."

The Scientific Committee for Cosmetology referred to in that provision (hereafter "the Scientific Committee") was established by Commission Decision 78/45/EEC of 19 December 1977. (9)

13. Article 12 of the Directive provides for safeguard measures to be taken by a Member State. A Member State is permitted provisionally to prohibit the marketing of a product or subject it to special conditions, if the Member State has grounds to consider the product hazardous to health although complying with the requirements of the Directive. A Member State which makes use of that procedure must immediately inform the other Member States and the Commission, stating the grounds for its decision. The Commission is then required to consult the Member States concerned, following which it must "deliver its opinion without delay and take the appropriate steps". By Article 12(3):

"If the Commission is of the opinion that technical adaptations to the directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations."

(b) The Twelfth Directive

14. As we have seen, Article 8(2) of the Cosmetics Directive enables the Commission to adopt amendments to Annexes II to VII in accordance with the procedure laid down. From the preamble to the Twelfth Directive, it appears that the latter was adopted pursuant to Article 8(2). It is to be noted that, before the Twelfth Directive was adopted on 20 February 1990, the prohibition under German law on the use of OHP in cosmetics was notified to the Commission by the German Government on 16 January 1989 pursuant to Article 12(1) of the Cosmetics Directive. However, in response to the Court' s request to explain the procedure followed in the adoption of the measures contained in the Twelfth Directive, the Commission confirmed that, notwithstanding that notification, the procedure followed in every case was the one prescribed by Article 8(2). The Commission also stated that, although the Scientific Committee was consulted in respect of certain of those measures, the opinion of the latter was not obtained as regards the proposed ban of OHP. The reason why the Scientific Committee was not consulted in respect of OHP was that neither the Commission nor a Member State made any request for such a consultation.

15. Article 1(1) of the Twelfth Directive amended Annex II of the Cosmetics Directive by adding OHP to the list of prohibited substances contained in that Annex, as well as adding certain other substances to that list and making various other amendments. By Article 2 of the Twelfth Directive Member States were required to ensure that, as from 1 January 1991, neither manufacturers nor importers established in the Community place on the market cosmetic products containing the substances mentioned in Article 1(1), and that after 31 December 1991 such products are not sold or otherwise disposed of to the final consumer.

(c) The Medicines Directive

17. Article 1 of the Medicines Directive defines a "proprietary medicinal product" as:

"Any ready-prepared medicinal product placed on the market under a special name and in a special pack."

Article 1 defines a "medicinal product" as follows:

"Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medicinal diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product."

By Article 2(1), as amended, (11) the Directive applies in particular to proprietary medicinal products for human use intended to be placed on the market in Member States. By Article 3, as amended:

"No medicinal product may be placed on the market in a Member State unless an authorization has been issued by the competent authority of that Member State."

Rules governing the application for, and the granting of, such authorizations are laid down by Articles 4 to 10 of the Directive. In particular, Article 5, as amended, provides as follows:

"The authorization provided for in Article 3 shall be refused if, after verification of the particulars and documents listed in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not as declared. Authorization shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Article 4."

18. Further rules relating to applications for the authorization of proprietary medicinal products were laid down by Council Directive 75/319/EEC of 20 May 1975. (12) Other Directives lay down rules regulating such matters as classification, labelling and advertising of medicinal products (13) and the harmonization of application requirements and testing procedures. (14)

20. It is common ground that OHP is an active ingredient of Setaderm, and evidence regarding the intended effects of OHP has been put before the Court in order that the Court can decide the question of the validity of the contested provision. It can be seen therefore that the Court would, if necessary, be in a position to give relatively detailed guidance to the national court on the classification of Setaderm as a medicinal or cosmetic product. I now turn to a consideration of that question.

Cosmetic and medicinal products

"As regards the meaning of 'restoring, correcting or modifying physiological functions', it is clear from the aim of health protection pursued by the Community legislature that the phrase must be given a sufficiently broad interpretation to cover all substances capable of having an effect on the actual functioning of the body.

However, that criterion does not serve to include substances such as certain cosmetics which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions."

It is for the national courts to determine on a case-by-case basis the classification of each product having regard to its pharmacological properties ..., to the way in which it is used, to the extent to which it is sold and to consumers' familiarity with it."

22. In the present case there is evidence before the Court regarding the actual and purported physiological effects of OHP and which is therefore relevant to the question whether Setaderm is a medicinal product. The expert report by Professor Dr Walter Braun commissioned by the Verwaltungsgericht is contained in the national file lodged at the Court. The Court has requested and received a copy of a memorandum of the Bundesgesundheitsamt (Federal Office of Health) on the effects of OHP on the human organism, dated 28 August 1984, as well as its comments on Professor Braun' s report. (15) The Court has furthermore requested and received Angelopharm' s response to the German Government' s comments. Finally, the Court invited the Commission to comment on Professor Braun' s report. The Commission indicated that it wished to associate itself with the German Government' s comments, but failed to produce any written comments on the report within the time-limit laid down by the Court.

23. From Professor Braun' s report it appears that it was not until the 1970s that any solid scientific evidence emerged of the causes of premature baldness in men. Results were however then obtained which indicated that the male hormone testosterone had a causative role when it was converted, in the presence of 5 *-Reductase, into the hormone 5 *-Dihydrotestosterone. It appears that the latter substance has a harmful effect on the sebaceous glands in the scalp and the roots of the hair. The search therefore began for an agent which would either block the production of 5 *-Dihydrotestosterone or inhibit its effects, and thereby prevent the loss of hair. In 1982 findings were published which indicated that OHP might have such an action when applied locally to the scalp; it was suggested that OHP attaches itself to 5 *-Reductase and thereby inhibits the production of 5 *-Dihydrotestosterone. It appears that an alternative explanation of the results is that OHP acts directly on 5 *-Dihydrotestosterone in order to inhibit its effects.

24. It seems to me that a product which is used with a view to preventing hair loss, or restoring hair growth, by inhibiting the production or effects of a hormone occurring naturally in the tissue of the scalp, is a product which is intended to have an effect on the physiological functioning of the body. It cannot be said that such a product does not have, or is not intended to have, a significant effect on the metabolism: the product purports to achieve its effect precisely by means of an interference in a metabolic process which would otherwise naturally occur, in this case the conversion of testosterone into 5 *-Dihydrotestosterone in the presence of 5 *-Reductase (or, alternatively, by means of an inhibition of the effect of 5 *-Dihydrotestosterone itself). It seems to me therefore that such a product must fall within the definition of "medicinal product" contained in Article 1 of the Medicines Directive: see paragraphs 17 and 21 above. Moreover, as we have seen, it is not material to the classification of a product as a medicinal product whether its active ingredient actually has the intended effect. It is sufficient if the product, when placed on the market, is held out as having such an effect.

25. Angelopharm submits that Setaderm does not have any effect on the human metabolism and does not strictly speaking modify the way in which it functions, because its intended effect occurs only in the scalp, at the level of the roots of the hair. Angelopharm suggests that, for a substance to "significantly affect the metabolism" within the meaning of paragraph 22 of the Court' s judgment in Upjohn, it must affect such matters as the blood, the blood pressure, and the functions of the liver, the kidney or the sexual organs.

26. I do not accept that, for the purposes of ascertaining whether a substance is a medicinal or a cosmetic product, the notion of "metabolism" can be so narrowly construed. Although some functions of the body are no doubt more essential for the continuation of life than others, it is clear that all aspects of the body' s internal functioning must be included in the "physiological functions" referred to in Article 1 of the Medicines Directive. In particular, the functions of the body which are regulated or affected by hormones must be so covered. Thus it seems to me that in the Upjohn case the Court intended to draw a distinction between effects which modify the functioning of the body, and effects which are purely cosmetic in the sense of modifying the appearance of the body without having any influence on its inner processes or functions. A product which is used with a view to modifying the metabolic processes occurring in the scalp, at the level of the roots of the hair, is clearly intended to have a significant effect on the metabolism of that part of the body. (16) It may be of course that the effect in question is beneficial or neutral, and that it is without side-effects on other parts of the organism. That however can only be established according to the procedures laid down for the authorization of medicinal products. Furthermore, although the list of cosmetic products contained in Annex I to the Cosmetics Directive is clearly for illustrative purposes only, it is to be noted that none of the categories of "hair care products" mentioned therein would appear to include a product intended to affect hormonal activity in the tissue of the scalp.

27. As I have already mentioned, Setaderm has already been classified as a cosmetic product for the purposes of German law by a decision of the Oberverwaltungsgericht Hamburg. The grounds for that classification do not appear from the order for reference. However, a copy of the judgment of the Oberverwaltungsgericht is on the national file lodged at the Court. (17) It appears that the judgment of the Oberverwaltungsgericht is based on the ground that substances which serve cosmetic purposes are to be classified as cosmetic products, rather than as medicines, when their main purpose is not to remedy or alleviate disease, discomfort, physical injury or pathological complaints. It is clear from the Court' s subsequent judgment in Upjohn that a classification of a product as a cosmetic on the basis of such a criterion can no longer be regarded as correct as a matter of Community law, and that the notion of medicinal product extends to any product which has (or is held out as having) a significant effect on the metabolism: see paragraph 21 above.

28. It is of course for the national court to establish, on the basis of the evidence at its disposal, whether Setaderm is purported to have the effects described in Professor Braun' s report or similar effects. If it is indeed intended to market Setaderm on the basis that it has such effects, however, it seems to me that the national court would have no option but to classify Setaderm as a medicinal product. As we have already seen, it would then follow that the provisions of the Cosmetics Directive would be irrelevant, and the provisions of the Medicines Directive would apply instead: see Upjohn, cited above in paragraph 5, at paragraphs 30 to 33 of the judgment. Setaderm could not be marketed in Germany without appropriate authorization given pursuant to the requirements of the Medicines Directive, and following a rigorous procedure of examination designed to verify both the safety and effectiveness of the product.

29. In that case, therefore, even if the prohibition of OHP under Community and national legislation were held to be invalid, Angelopharm would still not be entitled to market Setaderm as a cosmetic product. As we shall see, however, on the view I take the invalidity of the prohibition has in the event not been established. I now therefore turn to consider what answers are to be given to the questions referred.

Consideration of the questions referred

30. It will be recalled that the Verwaltungsgericht has referred questions on both the validity and the effect of the contested provision. It is clear that national courts have no duty under Community law to enforce provisions implementing a Community measure which has been declared invalid. Similarly, a Community measure which has been declared invalid cannot have direct effect. I shall therefore first discuss the answer which should be given to the third question referred, which concerns the validity of the Twelfth Directive, before turning to the other two questions.

(a) The validity of the prohibition of OHP

31. Angelopharm raises two objections to the validity of the prohibition of OHP contained in the contested provision. In the first place, Angelopharm suggests that the prohibition was introduced in breach of essential procedural requirements, and in particular in breach of a requirement to consult the Scientific Committee for Cosmetology referred to in Article 8(2) of the Cosmetics Directive. Secondly Angelopharm submits, in effect, that the prohibition was disproportionate to the aims of the Directive, in that no sufficient likelihood has been established that products containing OHP pose any risk to the health of the consumer. I shall take each of those points in turn.

(1) The procedural requirements for the prohibition

32. As I have already mentioned, the preamble to the Twelfth Directive states that it was adopted pursuant to Article 8(2) of the Cosmetics Directive, and the Commission has confirmed that the procedure followed was indeed that laid down by Article 8(2), as opposed to the safeguard procedure laid down by Article 12. It will be recalled that Article 8(2) provides that:

"The amendments necessary for adapting Annexes II to VII to technical progress shall be adopted in accordance with the same procedure [namely 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." [my emphasis]

33. According to the sixth recital to the Twelfth Directive:

"... the measures provided for in this Directive are in accordance with the opinion 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".

Thus (subject to a point considered below in paragraph 43) it appears that the Regulatory Committee was duly consulted in accordance with Article 10. In contrast, the preamble to the Directive does not refer to any prior consultation of the Scientific Committee. As we have seen, in its reply of 26 November 1992 to written questions put by the Court, the Commission confirmed that no such consultation took place as far as the prohibition of OHP was concerned. In its reply of 1 April 1993 to further questions put by the Court, the Commission stated however that the Scientific Committee was consulted in relation to certain other substances dealt with in the Twelfth Directive. The Commission annexed to its reply of 1 April 1993 the final draft of the Directive; from the "exposé des motifs" attached to that draft it appears that the Scientific Committee was consulted in relation to certain of the colouring agents prohibited by Article 1(1) of the proposed Directive, in relation to a colouring agent permitted by Article 1(6), and in relation to an addition to the list of permitted preservatives made by Article 1(8)(a). The Commission explained that the Scientific Committee was not consulted in relation to OHP because neither the Commission itself nor any of the Member States had requested such a consultation.

34. By a written question the Court invited Angelopharm, the German and United Kingdom Governments and the Commission to submit observations on whether consultation of the Scientific Committee is mandatory in the case of every amendment made under the procedure laid down by Article 8(2), or whether such a consultation is only required when a request is made by the Commission or one of the Member States. Views were also invited on the consequences of any failure to consult for the validity of the measures adopted.

35. Although in its written observations Angelopharm inclined towards the view that consultation of the Scientific Committee is not always a mandatory requirement, Angelopharm now submits that such consultation is required whenever measures are adopted under the procedure laid down by Article 8(2), and that it is moreover an essential procedural requirement for the adoption of such measures. On Angelopharm' s view, therefore, the failure to consult the Scientific Committee in respect of the proposed prohibition of OHP renders the Twelfth Directive invalid in so far as it prohibits the sale of cosmetic products containing OHP. In the view of the Commission and the German and United Kingdom Governments, on the other hand, consultation is required only when either the Commission or one of the Member States so requests. It appears that in making amendments under Article 8(2) the consistent practice has been to consult the Scientific Committee only when a specific request to do so has been made.

36. The United Kingdom Government suggests that, if consultation of the Scientific Committee were indeed a mandatory requirement of the procedure laid down by Article 8(2), the words "at the initiative of the Commission or of a Member State" would be otiose. That does not however follow. As we have seen, the Scientific Committee for Cosmetology was set up by Commission Decision 78/45/EEC of 19 December 1977, cited above in paragraph 11. (18) Article 2(1) of the Decision provides that:

"The Committee may be consulted by the Commission on any problem of a scientific or technical nature in the field of cosmetic products ...".

By Article 9(1) of the Decision:

"The proceedings of the Committee shall relate to requests by the Commission for opinions. ...".

The Decision establishing the Scientific Committee makes no specific provision for the consultation of the Committee by a Member State. Thus, as Angelopharm points out, in the absence of any reference to consultation "at the initiative ... of a Member State" it would be unclear whether the procedure provided for by Article 8(2) could be initiated by a Member State as well as by the Commission. Even if consultation were mandatory, therefore, the reference to "the initiative of the Commission or of a Member State" would not be otiose.

37. At least when Article 8(2) is read in isolation, the words "after consultation ... at the initiative of the Commission or of a Member State" in that provision are perhaps most naturally read as meaning that the opinion of the Scientific Committee need only be obtained when the Commission or a Member State so requests. The matter might however appear less clear when the wording of Article 8(2) is compared with the corresponding wording of Article 10. The first step in the procedure prescribed by Article 10 is as follows:

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

By Article 9(1), the chairman of the Regulatory Committee is the representative of the Commission. There is of course no doubt that, where the procedure laid down by Article 10 is to be followed, the opinion of the Regulatory Committee must be sought. A prior request for the opinion of the Regulatory Committee is accordingly a mandatory requirement for the adoption of measures under the procedure laid down by Article 10. The purpose of the words I have emphasized is merely to ensure that the procedure of Article 10 may be initiated by one of the Member States and not only by the Commission. Thus, although the Regulatory Committee is chaired by the Commission, the Commission cannot prevent a draft of measures to be adopted from being referred to the Committee. It might be argued therefore that the corresponding words in Article 8(2) have a similar purpose, namely that of making it clear who has the right to initiate a mandatory process of consultation.

38.Despite the similarity of wording in Article 8(2) and Article 10(1), however, the effect is in my view different in the two cases. If the legislator had intended consultation to be a mandatory requirement under Article 8(2), the requirement would, it seems to me, have been expressed in less ambiguous terms. In contrast it is clear, in particular, from Article 10(2) that under the procedure laid down by Article 10 the Regulatory Committee must be consulted. It can be seen in fact that the intervention of the Regulatory Committee in the adoption of measures under Article 10 serves a different purpose from the contribution made by the Scientific Committee under Article 8(2). The former Committee forms part of the mechanism of control, by the representatives of the Member States, of the exercise by the Commission of its delegated powers. That mechanism is supplemented by the right given to each Member State to obtain an opinion from the Scientific Committee under the procedure laid down by Article 8(2); but it is clear that an actual consultation of the Scientific Committee is not a necessary part of such control where neither the Commission nor any Member State considers it appropriate. As the United Kingdom pointed out at the hearing, the representatives of the Member States on the Regulatory Committee will in any case be assisted by their own expert advisers. Furthermore there are likely to be obvious cases in which consultation is clearly unnecessary: it would be strange therefore if consultation of the Scientific Committee were a mandatory requirement.

39.I conclude therefore that prior consultation of the Scientific Committee is required under Article 8(2) only when the Commission or a Member State so requests.

40.If no request for an opinion of the Scientific Committee has been made by a Member State, can it be argued that the Committee should have been consulted in the circumstances of an individual case? In its written observations Angelopharm suggests that, even if it is accepted that the Commission possesses a wide discretion in deciding whether to consult the Scientific Committee, that discretion is not unlimited. Angelopharm suggests that consultation may in effect be a mandatory requirement in particularly complex or difficult cases such as the present one.

41.It seems to me however that, once it is accepted that consultation under Article 8(2) is not a mandatory requirement, it would be difficult in the extreme to distinguish cases in which the opinion of the Committee must be obtained from those in which the Commission retains a discretion in the matter. It is clear that the purpose of the provision for consultation is to make available an additional opinion where either a Member State or the Commission considers such advice necessary. If however it is not considered necessary to consult the Scientific Committee, no obligation to consult can be implied.

42.I conclude that the contested provision cannot be held to be invalid for breach of a requirement to consult the Scientific Committee for Cosmetology.

43.In its written observations, and in its answers to the Court's questions, Angelopharm also raises the question whether the procedure laid down by Article 10 was correctly followed in the adoption of the Twelfth Directive. Angelopharm submits that the procedure followed was irregular because - as can be seen from the minutes of the relevant meeting of the Regulatory Committee which are attached to the Commission's reply to questions of 26 November 1992 - no separate vote was taken on the individual measures contained in the proposed Directive, but only on the proposal taken as a whole. Angelopharm has not however pointed to any provision of Community law which would preclude measures being adopted by such a procedure. There is in particular nothing in the wording of Article 10 to suggest that the Regulatory Committee cannot adopt its opinion by voting on a draft containing more than one proposed measure. In any event, since a Member State which assents to a draft containing several measures must also be taken to have assented to each measure contained in the draft, it is difficult to see how the two procedures could lead to different results. I conclude therefore that Angelopharm has not identified any essential procedural requirement which was breached in the adoption of the contested provision.

(2) Proportionality of the prohibition

44.Both Angelopharm and the Verwaltungsgericht take the view that the expert report by Professor Braun is sufficient to establish that OHP poses no risk to human health when used in a cosmetic product such as Setaderm. It will be recalled that I have already concluded that the evidence contained in that report suggests that Setaderm is to be classified as a medicine rather than a cosmetic: see paragraphs 21 to 28 above.

45.Even if particular products containing a given substance are classified as medicines it may of course still be necessary to prohibit the substance under the Cosmetics Directive, since certain other products containing the substance may be properly classified as cosmetics. Indeed, as the United Kingdom Government pointed out at the hearing, a large number of the substances listed in Annex II of the Cosmetics Directive are used in medicinal products. As we have seen however, when a product is classified as a medicine it will in any case be subject to the rules governing medicinal products: see paragraph 5 above.

46.Conversely, a substance may be permitted as an ingredient of a cosmetic even where it is also an ingredient of other products classified as medicines. That follows from the fact that a product can be regarded as a cosmetic only when it is intended to be applied externally and with a view to certain limited purposes: see the definition of "cosmetic product" given in Article 1(1) of the Cosmetics Directive, cited in paragraph 8 above. Thus when applied externally a substance may have no physiological effects, and in particular no undesirable effects.

47.None the less, in considering the validity of the prohibition of OHP under the Cosmetics Directive, the conclusions reached above concerning the classification of Setaderm as a cosmetic or medicinal product should, I think, be borne in mind. Although OHP must by definition be applied externally when used in a product purporting to be a cosmetic, it will be recalled that the intended effects of such a use include an action on the hormonal metabolism of the scalp. As we shall see below, that fact may be relevant in deciding whether it was justified to prohibit the use of OHP in cosmetic products.

48.The Verwaltungsgericht asked Professor Braun to consider the following two questions:

1."1. Does existing theoretical and empirical knowledge indicate that hormones in general or those of the type 11 *-Hydroxyprogesterone in particular may have harmful effects on the health of the human body even when applied externally?

2.On the basis of the results of existing research (including those produced by Angelopharm), can one exclude with an exceptionally high degree of probability (certainty) that the external application of 11 *-Hydroxyprogesterone has negative effects on the human body?"

It appears from the order for reference that "11 *-Hydroxyprogesterone" is another name for OHP.

49.In Part I of his report Professor Braun summarizes the events leading to the commissioning of his report and quotes extracts from the memorandum of the Bundesgesundheitsamt of 28 August 1984; it will be recalled that a copy of that memorandum was produced by the German Government at the request of the Court (see paragraph 22 above). In Part II Professor Braun explains the methodology he proposes to adopt and sets out the conceptual and factual background. Part III summarizes the existing state of research on OHP, referring in particular to the work of Tamm and his collaborators and to the earlier work of Byrnes, Stafford and Olson which is cited in the memorandum of the Bundesgesundheitsamt. Part IV contains a general discussion of the effects and side-effects of OHP, and Professor Braun's concluding evaluation is contained in Part V.

50.Professor Braun reaches the conclusion that, on the existing evidence, there is no reason to suppose that OHP has any harmful side-effects when applied externally. The risk of harmful effects can be excluded with an exceptionally high degree of probability. In particular, possible harmful side-effects cannot be inferred from the fact that some hormones related to OHP, such as progesterone, may have harmful effects, since a substance may have the chemical structure of a hormone without having the same effects. Indeed, Professor Braun suggests that OHP may have no hormonal effects, and in particular that it may not have the advertised effect of stimulating hair growth.

51.The German Government comments on Professor Braun's report as follows. The report does not take sufficiently into consideration the results of the research of Byrnes and his collaborators, which gave rise to the initial doubts regarding the safety of OHP. The absence of hormonal side-effects of OHP has not yet been established with the requisite degree of certainty by means of animal experiments. The German Government also disputes the claim made in the report that OHP has been shown not to penetrate the skin and be absorbed into the organism. In the view of the German Government, the absence of any reports of harmful side-effects among users is not of any evidential value, given the limited diffusion of the product and the lack of clinical surveillance. More generally, the report is based on a mistaken view of the allocation of the burden of proof and the amount of experimental evidence which would be necessary to discharge that burden.

52.As I have already mentioned, Angelopharm was invited to respond to the German Government's comments on the report. Angelopharm comments as follows. Contrary to the view of the German Government, the burden of proof is on the Commission and not on Angelopharm. Thus in order to prohibit a substance under Annex II of the Cosmetics Directive the Commission is required to establish that it may be a risk to health, in contrast to the position under the Medicines Directive where it is the applicant for authorization who must establish the safety of the product. Angelopharm suggests that the German Government places undue emphasis on the results of the experiments of Byrnes and his collaborators, which have been superseded by the more recent research on OHP. Angelopharm refers to a note by Professor Tamm dated 1 March 1993, in which the significance of the animal experiments carried out by Byrnes is disputed, and in which Professor Tamm refers to more recent clinical trials carried out on human volunteers both by himself and by other teams of researchers. Professor Braun's doubts concerning the efficacy of OHP are moreover not relevant, since Angelopharm claims only that hair loss can be arrested or reduced, not that it can restore hair growth to a bald scalp. Finally, Angelopharm suggests that the efficacy of Setaderm is demonstrated by its own willingness to engage in the present litigation.

53.In what follows I shall leave aside the question of the efficacy of Setaderm. It is to be noted that, even if the marketing of cosmetic products containing OHP were permitted by the Cosmetics Directive, Member States would still be required by Article 6(3) of the Directive to ensure that cosmetic products are not advertised as having characteristics which they do not in fact possess.

54.As we have seen, in contrast to the Medicines Directive the Cosmetics Directive does not impose any requirement for a product to be authorized before it can be sold as a cosmetic; on the contrary, all products which satisfy its requirements enjoy a right to be freely marketed under Article 7 of the Directive. Thus, while the sale of a medicinal product is forbidden until the product has received specific authorization, the sale of a cosmetic is permitted unless it has been prohibited or restricted under Articles 4 and 5 of the Directive or under the safeguard procedure of Article 12.

55.There is therefore no doubt that, under the Cosmetics Directive, the authorities introducing a prohibition or a restriction on a substance used in a cosmetic product must have grounds for introducing such a provision, whether those authorities are a Member State acting under Article 12 of the Directive or the Commission or the Council acting under Articles 8(2) or 10. On the other hand, it seems to me that such grounds exist wherever there is reason to believe that the substance may have an effect on the human metabolism. Where in particular a substance is intended to have such an effect, it seems to me that such grounds are made out. Accordingly, where a decision has been taken to prohibit such a substance under the Cosmetics Directive, it is for a party challenging the validity of the decision to demonstrate that the substance in question is harmless.

56.Those conclusions follow in my view from the aims and structure of the Cosmetics Directive. As we have seen, the Directive seeks to ensure that products satisfying the requirements of the Directive, which may include prohibitions and restrictions imposed on the ground of the protection of health, enjoy free circulation within the Community. In the case of a cosmetic product there is an initial presumption that it should enjoy free circulation, because cosmetic products, unlike medicines, are not primarily intended to affect the functioning of the body as opposed to its outward appearance. A hair dye, for instance, can initially be presumed to be safe from the point of view of health, because it is by definition not intended to do anything other than affect the colour of the hair. However, as soon as it is discovered that the dye contains an active ingredient which may affect physiological functions in the scalp, the product can no longer benefit from the presumption that it is safe. If a decision is taken, in accordance with the procedures laid down by the Directive, to prohibit the marketing of products containing such an ingredient, it will be for the party challenging the decision to show that the product is safe.

57.Where, as in the present case, the product in question is specifically intended to affect the metabolism, the above considerations apply a fortiori. In such a case it is no longer necessary to identify a possible side-effect of the use of the cosmetic in order to rebut the initial presumption that the product is safe, since if the product is fit for its intended purpose it must necessarily have effects on the functioning of the body, and not merely on its outward appearance; and where one part of the metabolism is affected, it can no longer be assumed that other, unintended, effects will not also be present. It is moreover clear that the vendor of such a product cannot be permitted to argue that the product is safe because it is ineffective.

58.In the present case, it is to be noted in particular that, according to the memorandum of the Bundesgesundheitsamt of 28 August 1984, OHP belongs to a category of substances known as "steroids", a category which also contains such highly active hormones as oestrogens and progestogens. The principal claim made on behalf of OHP is that, when applied externally, it has some of the effects of such hormones but none of their unwanted side-effects. In such circumstances it seems to me that there can be no doubt that it is for Angelopharm to show that OHP does indeed have no such unwanted effects.

59.It follows, in my view, that the Commission was prima facie entitled to introduce a prohibition on OHP under the procedure laid down by Article 8(2). Indeed it might be argued that those considerations are in themselves sufficient to rebut the allegation that the contested provision is disproportionate to its objective. In its written observations, the United Kingdom Government suggests that to establish that the provision was disproportionate it would have to be shown that the legislature had committed a manifest error in the exercise of its discretion. It might therefore be argued that the chemical structure and intended effects of OHP were in themselves sufficient to justify its prohibition as an ingredient of cosmetics.

60.In support of its submission that the Commission would have to be shown to have committed a manifest error of appraisal, the United Kingdom Government refers to the judgment of the Court in Case C-331/88 Fedesa and Others [1990] ECR I-4023. In that case the Court, after setting out the conditions necessary for a measure to conform to the principle of proportionality, stated at paragraph 14 of the judgment:

"However, with regard to judicial review of compliance with those conditions it must be stated that in matters concerning the common agricultural policy the Community legislature has a discretionary power which corresponds to the political responsibilities given to it by Articles 40 and 43 of the Treaty. Consequently the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue ..."

60.It is not clear that that statement, which is based on the broad political responsibilities of the legislature in the sphere of the common agricultural policy, can be extended without qualification to measures taken in other spheres. It is however true that, in prohibiting the sale of products on the ground of protection of human health pursuant to powers given by a measure adopted under Article 100 of the Treaty, the Community legislature must be taken to have a certain margin of discretion. Furthermore where, as here, there is evidence which establishes that the substance in question is intended to have physiological effects even when used as an ingredient of a cosmetic, it is difficult to see how that discretion could be shown to have been exceeded. The short answer to Angelopharm's challenge to the validity of the prohibition might therefore be that, on the evidence before the Court regarding the intended effects of OHP, there can be no legitimate reason for using OHP as an ingredient of a cosmetic as opposed to a medicine.

61.Even if it were accepted that OHP could be used as an ingredient of a cosmetic, Angelopharm would still have to show that the doubts raised as to the safety of such a cosmetic were unjustified. Thus Angelopharm would at the very least have to establish that OHP has no harmful side-effects under normal conditions of use. In addition, Angelopharm would have to establish that a product containing OHP is sufficiently safe to be sold as a cosmetic rather than as a medicinal product, and hence sold without the additional safeguards which, as we have seen, are required in the case of an authorized medicine. Furthermore the standard of proof which Angelopharm would have to meet is a high one: given that OHP is intended to have effects on the metabolism, the standard must in my opinion be at least as onerous as that required to obtain authorization for a product under the Medicines Directive.

62.In the case of medicinal products, a substantial degree of harmonization of the standards and procedures to be applied in establishing the safety of a product is provided by Council Directive 75/318/EEC of 20 May 1975. (22) If a product containing OHP as its active ingredient had received authorization as a medicine in at least one Member State, or had undergone such toxicological and pharmacological tests and clinical trials as would make it likely to receive such authorization, Angelopharm would have gone some way to meeting the required standard of proof. As we have seen, even then Angelopharm would have to show that products containing OHP can safely be sold as a cosmetic, as opposed to being subjected to the more rigorous requirements which apply in the case of a medicine.

63.On the evidence available to the Court, it is I think clear that Angelopharm has not met the required standard of proof. No suggestion has been made that a product containing OHP as its active ingredient has been authorized as a medicine in a Member State. It appears that Angelopharm did initially apply for such authorization in respect of Setaderm, but that it withdrew its application when Setaderm was subsequently classified as a cosmetic by the Oberverwaltungsgericht Hamburg. No documents relating to that application have been placed as evidence before the Court. As I have already observed, even if Setaderm or a similar product had been authorized as a medicine in a Member State, that might not in itself be sufficient to demonstrate that OHP may be safely used as an ingredient of a cosmetic.

64.As we have seen, both Angelopharm and the Verwaltungsgericht regard the conclusions reached by Professor Braun's report as sufficient to establish the safety of cosmetic products containing OHP. However, in the light of the above considerations on the standard of proof which is applicable in the present circumstances, it is I think clear that an expert's report of that kind, unsupported by further experimental evidence, cannot be regarded as sufficient for such a purpose. It is moreover to be noted that Professor Braun's conclusions as to the safety of OHP are mainly based on the clinical trials performed on human volunteers by Professor Tamm and his collaborators. Apart from a toxicity test performed on mice by Professor Tamm and reported in 1983, Professor Braun makes detailed reference to only one publication reporting the results of animal experiments, namely an article by Kontula and others in Acta Endocrinologica 1975. It appears that only one species of animal was used in that experiment, and that the injected doses were on Professor Braun's own assessment "relatively low". It is not clear what results are considered to be established by that experiment, but it is clear in any event that it would not in itself be sufficient to meet standards similar to those required in the case of medicinal products by Part 3.II of the Annex to Directive 75/318/EEC, cited above. (It is to be noted that, even in the case of a substance which has been shown not to be absorbed into the system when applied locally, single dose toxicity tests on animals are still required under paragraph A(1) of Part 3.II: see Part 3.I(2).) It seems to me therefore that the German Government is correct to point to the inadequacy of existing toxicological evidence regarding the effects of OHP. As we have seen, Angelopharm suggests that the German Government places undue reliance on the earlier animal experiments performed by Byrnes and his collaborators. It is of course open to Angelopharm to attempt to refute the conclusions drawn from those experiments by means of better experimental data. It is true that there are further references to previous experimental data in the note by Professor Tamm dated 1 March 1993, but it is I think clear that Angelopharm has not produced the evidence which would be necessary for it to succeed.

65.Finally, I should mention the suggestion made by Angelopharm in its written observations, according to which the prohibition of OHP might be held to be disproportionate in that the Commission could have included OHP in Annex III rather than in Annex II of the Cosmetics Directive. It will be recalled that Annex III, Part 1, contains a list of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down, whereas Annex II contains a list of substances which are prohibited under any conditions. Thus Angelopharm appears to suggest that the goal of protecting public health could equally well have been secured by permitting the use of OHP, but subjecting it to restrictions, as by prohibiting it altogether. It is sufficient to note, however, that Angelopharm does not put forward any additional evidence in support of that hypothesis, nor does it indicate precisely what conditions or restrictions might be held to suffice in the case of OHP.

66.I accordingly reach the conclusion that no ground has been advanced which is sufficient to establish the invalidity of the contested provision. It is therefore necessary to consider the other questions referred by the Verwaltungsgericht, which concern the effects of that provision in national law.

(b) The effect of the prohibition of OHP

67.As we have seen, by its first question the Verwaltungsgericht asks whether a national court is prevented from regarding as invalid a national provision which does nothing more than implement the provisions of a Community directive. It appears that, in the absence of such a duty, the Verwaltungsgericht would be minded to regard as invalid the national provisions implementing the prohibition of cosmetic products containing OHP, on the ground that a sufficient risk to the health of the consumer has not been established.

68.It is of course clear that only this Court can declare Community legislation invalid: see Case 314/85 Foto-Frost v Hauptzollamt Luebeck-Ost [1987] ECR 4199, at paragraphs 17 to 20 of the judgment. If a national court considers that a Community regulation may be invalid, it may under certain conditions temporarily suspend the enforcement of national measures which implement the regulation: see Joined Cases C-143/88 and C-92/89 Zuckerfabrik Suederdithmarschen and Zuckerfabrik Soest [1991] ECR I-415, at paragraphs 14 to 21 of the judgment. The national court must however have serious doubts as to the validity of the regulation, and the suspension may be granted only until the Court has delivered its ruling on the question of validity: ibid. at paragraphs 23 to 24 of the judgment.

69.In my view, the principles laid down in the Foto-Frost and Zuckerfabrik Suederdithmarschen cases must apply equally to directives and to regulations; it follows that a national court is prevented from declaring invalid, or otherwise disregarding, provisions which implement a directive, where the provisions are challenged on grounds which in effect impugn the validity of the directive. Where in particular the national provisions in question are necessary to give effect to a Community measure which was adopted on grounds of the protection of health, the national provisions cannot be regarded as invalid on the ground that they are disproportionate to that objective. For, if the national provisions could be challenged on such a ground, that would in effect put in issue the proportionality of the Community measure, and hence its validity.

70.For the purposes of the present case it is unnecessary to consider the wider question, adverted to by the United Kingdom at the hearing, whether a national court must refrain from regarding implementing measures as invalid even where the measures are challenged on a ground which has no bearing on the validity of the directive: for instance where the alleged invalidity consists in a failure to observe procedural requirements laid down by national law. Such a duty might be thought to follow from the national court's general duty, under Article 5 of the Treaty, to give effect to national measures implementing a directive. As the Court stated in Case C-106/89 Marleasing [1990] ECR I-4135, at paragraph 8 of the judgment:

"... the Member States' obligation arising from a directive to achieve the result envisaged by the directive and their duty under Article 5 of the Treaty to take all appropriate measures, whether general or particular, to ensure the fulfilment of that obligation, is binding on all the authorities of Member States including, for matters within their jurisdiction, the courts."

71.In Marleasing the Court deduced, from that general obligation, a duty of the national court to interpret national provisions so far as possible in the light of the wording and the purpose of the directive in order to achieve the result pursued by the latter. Once the period prescribed by the directive for implementation has expired, that duty is unaffected by the question whether the measures concerned were adopted before or after the adoption of the directive. It might similarly be argued that, in so far as questions concerning the validity and effect of national legislation fall within the jurisdiction of the national court, the latter must always be under a duty not to declare national measures invalid, or refrain from enforcing them, where to do so would frustrate the result pursued by the directive. It is however to be observed that such a duty could only arise where the national court did indeed have the jurisdiction to decide whether or not to give effect to the measures in question, and not for instance where the measures were vitiated by a procedural defect so grave as to render them non-existent. As I have already observed, however, the more general question does not arise in the circumstances of the present case.

71.It is clear, in any event, that a national court may not regard as invalid national measures which are necessary to give effect to a directive, if the ground of the alleged invalidity is that the measures are disproportionate. It is clear moreover that that obligation arises as soon as the period laid down for implementation of the directive expires. Thus, in the present case, once the periods laid down by Article 2 of the Twelfth Directive have expired a national court is precluded from regarding the measures as invalid.

72.In its written observations, the Commission suggests that no such obligation arises before the expiry of the period laid down for implementation. In my view, however, there may be circumstances in which the obligation arises even before the expiry of the implementation period. As regards the national court's duty of interpretation, I suggested in paragraph 23 of my Opinion in Case C-156/91 Hansa Fleisch Ernst Mundt [1992] ECR I-5567 that:

"Even where a Member State could not yet be in breach of its obligation correctly to implement a directive ..., because the period prescribed for implementation has not yet expired, the national courts are still in my view obliged to interpret in conformity with the directive any national measures already in force which are intended to implement it. In such a case, the duty so to interpret implementing provisions arises, not from the expiry of the period prescribed for implementation, but from the duty of the national court to co-operate with the other national authorities in their endeavour to implement the directive. For, once a Member State has decided to implement Community provisions, it seems to me that all the authorities of that State are bound by a general duty, under Article 5 of the Treaty, to facilitate the achievement of the Community's tasks by ensuring the success of that implementation."

73.In my view, the same principles apply to the national court's duty to refrain from regarding national measures as invalid. Once the period for implementation has expired, the duty arises in respect of all national measures which can be construed as giving effect to the Community provisions, whether or not the measures were adopted in order to implement the latter: compare Marleasing, cited above in paragraph 70. Until that period has expired, on the other hand, it is clear that a Member State retains its discretion as regards time and method of implementation. Thus, where no measures have been adopted in order to implement a directive, and the period prescribed for implementation has not yet expired, the national court can be under no duty to refrain from regarding as invalid national measures which achieve a similar result to the one pursued by the directive. Once a Member State has taken steps to implement a directive, however, all the authorities of the Member State are required to co-operate in ensuring the success of that implementation. It follows in particular that the national courts may not then frustrate a Member State's intention of implementing a directive by refusing to give effect to any implementing measure in force, at least if their reasons for doing so are based on grounds which put in issue the validity of the directive.

73.In the present case, it will be recalled that the sale of products containing OHP was prohibited under German law from 1 January 1988, but no prohibition of such products was required under Community law until 1 January 1991. The latter requirement was introduced by the Twelfth Directive which was adopted on 20 February 1990. By Article 2 of the Twelfth Directive, Member States were required to ensure that the products concerned are not placed on the market after 31 December 1990 or disposed of to the final consumer after 31 December 1991.

74.It is clear that the measures prohibiting OHP originally introduced by the German authorities were not intended to implement any Community provision, since no such provision prohibiting OHP had yet been adopted. Accordingly, when the German measures were introduced, the German courts retained any powers they enjoyed under national law to regard the measures as invalid. The position was not immediately affected by the adoption of the Twelfth Directive on 20 February 1990. However, it appears that on 21 March 1990 measures were taken to implement in German law the prohibitions introduced by Article 1(1) of the Twelfth Directive: see Article 1(3)(b) of the Seventeenth Regulation amending the Kosmetik-Verordnung. (23) By Article 3 of the Seventeenth Regulation those measures came into force on 31 March 1990. Accordingly, as regards the measures in force from that date, the German courts were precluded from regarding as invalid the prohibition under national law of the sale of cosmetic products containing OHP.

75.I would add that, contrary to the submission of Angelopharm, Member States were not prevented from implementing the prohibitions introduced by Article 1(1) of the Twelfth Directive before the expiry of the time-limits laid down in Article 2. Given that the prohibitions were introduced in order to protect public health, Article 2 cannot reasonably be interpreted as requiring Member States to allow the sale of such products until the expiry of the periods laid down. The purpose of the periods allowed by Article 2 is clearly to permit, but not to require, Member States to grant their distributors a period of grace before bringing the prohibitions into force. Thus, as soon as the Twelfth Directive was adopted, Member States were permitted to prohibit the sale of cosmetic products containing OHP. Contrary to the view of the Commission, therefore, a Member State would not have to rely upon the safeguard provisions of Article 12 of the Cosmetics Directive in order to prohibit such sales between the adoption of the Twelfth Directive on 20 February 1990 and the expiry of the periods prescribed by Article 2. Before 20 February 1990, on the other hand, a national court was not prevented from regarding as invalid any national measures prohibiting the use of OHP in cosmetics; indeed, before that date such measures would in addition be contrary to Article 7 of the Cosmetics Directive, unless notified by the Member State concerned pursuant to Article 12.

76.I conclude therefore that, in circumstances such as those of the present case, the national court is required to give effect to the national measures implementing a directive. It is accordingly unnecessary to answer the second question referred by the Verwaltungsgericht.

Conclusion

77.I am accordingly of the opinion that the questions referred by the Verwaltungsgericht Hamburg should be answered as follows:

(1)Examination of the questions referred has not revealed any factor of such a kind as to affect the validity of the prohibition of 11 *-Hydroxypregn-4-ene-3,20-dione and its esters, introduced by Article 1(1) of Commission Directive 90/121/EEC of 20 February 1990.

(2)A national court is precluded from refusing to give effect to a provision of national law on a ground which puts in issue the validity of a Community directive.

(*) Original language: English.

(1) - See Article 1(6) and (8) of the Ninth Regulation amending the Regulation on Cosmetics ( Neunte Verordnung zur AEnderung der Kosmetik-Verordnung ), of 20 March 1985 (BGBl. 1985 I, p. 586).

(2) - See the Fourteenth Regulation amending the Kosmetik-Verordnung, of 2 December 1988 (BGBl. 1988 I, p. 2206).

(3) - 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 (OJ 1990 L 71, p. 40).

(4) - Last amended by Council Directive 92/27/EEC of 31 March 1992 (OJ 1992 L 113, p. 8).

(5) - On the Community provisions governing the sale of medicinal products, see Leigh Hancher Creating the internal market for pharmaceutical medicines: An Echternach jumping procession? in Common Market Law Review 28 (1991), pp. 821-853.

(6) - See the amendment to Article 4 made by Article 7 of Council Directive 82/368/EEC of 17 May 1982 (OJ 1982 L 167, p. 1).

(7) - Cited above in note 6.

(8) - By Council Directive 83/574/EEC (OJ 1983 L 332, p. 38) and Council Directive 89/679/EEC (OJ 1989 L 398, p. 25).

(9) - OJ 1978 L 13, p. 24.

(10) - See Article 1(3)(b) and (4) of the Seventeenth Regulation amending the Kosmetik-Verordnung, of 21 March 1990 (BGBl. 1990 I, p. 589).

(11) - See Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11).

(12)- Second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13); last amended by Council Directive 92/27/EEC of 31 March 1992 (cited above in note 4).

(13)- See the Directives cited below in paragraph 45, note 19.

(14)- See Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ 1975 L 147, p. 1), as amended by Council Directive 89/341/EEC (cited above in note 11) and last amended by Commission Directive 91/507/EEC (OJ 1991 L 270, p. 32).

(15)- The memorandum of the Bundesgesundheitsamt appears to form the basis of the German Government's grounds for the prohibition of OHP given in its notification to the Commission of 16 January 1989, pursuant to Article 12 of the Cosmetics Directive. A copy of that notification is annexed to the German Government's written observations.

(16)- Cf. the opening paragraph of the article by Vermorken, Goos and Roelofs in Journal of Dermatology (1980) 102 (a copy of which is on the national file lodged at the Court), p. 695: During the last 10 years, the skin has been recognized as a major site for androgen metabolism, comparable to the prostate gland. ... .

(17)- A summary of the grounds of the judgment is also available on the JURIS database: see JURIS Document No 347021.

(18)- In the English version of the Decision, in contrast to Article 8(2) of the Cosmetics Directive, the Committee is referred to as the Scientific Committee on Cosmetology rather than for Cosmetology; there is however no corresponding inconsistency in the French and German versions.

(19)- See for instance Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use (OJ 1992 L 113, p. 1), Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use (ibid. p. 5), Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets (ibid. p. 8), and Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (ibid. p. 13).

(20)- Annexed to Angelopharm's reply to questions of 19 March 1993.

(21)- See the article by Tamm and Gauri in AErztliche Kosmetologie May/June 1983 pp. 2-4 (a copy of which is on the national file), at p. 2, where however OHP is described as a steroid derivative rather than as a steroid. The title of that journal (Medical Cosmetology) is perhaps not without interest in the present context.

(22)- Cited above in paragraph 18, note 14.

(23)- Cited above in paragraph 16, note 10; it will be recalled that the Seventeenth Regulation in particular added OHP to the list of prohibited substances contained in Part A of Annex I to the Kosmetik-Verordnung, and deleted OHP from the list of prohibited substances contained in Part B.