C-212/91

ANGELOPHARM v HAMBURG

OPINION OF ADVOCATE GENERAL JACOBS delivered on lojune 1993 *

My Lords, tives of OHP known as 'esters'. A prohibi­ tion on the sale of cosmetics containing OHP or its esters was subsequently included in the provisions of the Cosmetics Directive by an amendment to Annex II of the Direc­ tive; that amendment was made by Commis­ sion Directive 90/121/EEC of 20 February 1. In this case, the Verwaltungsgericht Ham­ 1990. 3In what follows I shall refer to that burg has referred three questions on the amending directive as 'the Twelfth Directive', validity and effect of a recent amendment to and I shall refer to the prohibition of OHP Council Directive 76/768/EEC of 27 July and its esters introduced by the Twelfth 1976 on the approximation of the laws of the Directive as 'the contested provision'. Since Member States relating to cosmetic products nothing in the present case turns upon the (OJ 1976 L 262, p. 169; hereafter 'the Cos­ distinction between OHP and the esters of metics Directive'). That reference is made in OHP, I shall refer throughout simply to the course of proceedings in which the plain­ 'OHP' . It appears that the Twelfth Directive tiff company, Angelopharm GmbH, requests was implemented in German law by an a declaration that it may lawfully produce amendment to the Kosmetik-Verordnung and market a hair product with the brand made on 21 March 1990: see paragraph name 'Setaderm'. Setaderm is designed to 16 below. inhibit the natural onset of baldness in men, and contains as an active ingredient the sub­ stance 11 a-Hydroxypregn-4-ene-3,20-dione (hereafter ΌHP' ).

'1.Is the national court prevented from regarding a national regulation as invalid or void if, and in so far as, it consists only 5. It appears that the questions at issue in of provisions implementing a directive the main proceedings relate only to the Cos­ within the meaning of the third paragraph metics Directive, and that no issue is raised of Article 189 of the EEC Treaty? 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 2. If not, does a directive under the third by law, regulation or administrative action paragraph of Article 189 of the EEC relating to medicinal products (OJ, English Treaty then have direct effect? Special Edition 1965-1966, p. 20; hereafter 4 'the Medicines Directive' ). It is clear how­ ever 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 3. If the answer to either of the above ques­ within the definition of cosmetic product tions is affirmative, is the prohibition on given in the Cosmetics Directive: see Case 11 a-Hydroxypregn-4-ene-3,20-dione and C-60/89 Monteil and Samanni [1991] ECR its esters under the Twelfth Commission I-1547, at paragraphs 15 to 17 of the judg­ Directive 90/121/EEC of 20 February ment, and Case C-112/89 Upjohn [1991] 1990 valid?' 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 con­ tested provision were held to be invalid. 5 4. By those questions, the Ver­ waltungsgericht asks in substance whether a national court is obliged to enforce a prohi­ bition laid down by Community law not­ 4 — Last amended by Council Directive 92/27/EEC of 31 March withstanding that legislation implementing 1992 (OJ 1992 L 113, p. S). 5 — On the Community provisions governing the sale of medici­ the prohibition in national law would other­ nal products, see Leigh Hancher 'Creating the internal mar­ wise be invalid, and, if so, whether the pro­ ket for pharmaceutical medicines: An Echternach jumping procession?' in Common Market Law Review 28(1991), hibition of OHP introduced by the pp. 821-853.

An illustrative list of such products is con­ '... the main objective of these laws is the tained in Annex I to the Directive; however, safeguarding of public health and..., as a by Article 1(3), products containing one of result, the pursuit of the same objective must the substances listed in Annex V are inspire Community legislation in this sec­ excluded from the scope of the Directive.

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9. By Article 2 of the Directive, cosmetic 11. Article 8 provides for the technical adap­ products put on the market within the Com­ tation of the Directive. Article 8 originally munity must not be liable to cause damage provided as follows: to human health when they are applied under normal conditions of use. By Article 3, Member States are required to take all neces­ sary measures to ensure that only cosmetic '1 . In accordance with the procedure laid products which conform to the provisions of down in Article 10 the following shall the Directive may be put on the market. be determined: Article 4(1), as amended, provides in particu­ lar that Member States must prohibit the marketing of cosmetic products containing substances listed in Annex II, without preju­ dice to their general obligations under — the methods of analysis necessary for Article 2; certain technically unavoidable checking the composition of cosmetic traces are however permitted by Article products, 4(2). 6Certain other substances, in particular those listed in Part 1 of Annex III, are to be prohibited 'beyond the limits and outside the conditions laid down'. — the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.

cedure [namely that laid down in Article 10], 13. Article 12 of the Directive provides for after consultation of the Scientific Commit­ safeguard measures to be taken by a Member tee for Cosmetology at the initiative of the State. A Member State is permitted provi­ Commission or of a Member State.' sionally to prohibit the marketing of a prod­ uct or subject it to special conditions, if the Member State has grounds to consider the product hazardous to health although com­ plying with the requirements of the Direc­ The Scientific Committee for Cosmetology tive. A Member State which makes use of referred to in that provision (hereafter 'the that procedure must immediately inform the Scientific Committee') was established by other Member States and the Commission, Commission Decision 78/45/EEC of stating the grounds for its decision. The 19 December 1977. 9 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):

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was notified to the Commission by the Ger­ sumer) under Community law from 1 Janu­ man Government on 16 January 1989 pursu­ ary 1991, and that the sale of such products ant to Article 12(1) of the Cosmetics Direc­ to the final consumer was prohibited under tive. However, in response to the Court's Community law from 1 January 1992. The request to explain the procedure followed in Community prohibition was implemented in the adoption of the measures contained in German law in March 1990 by means of an the Twelfth Directive, the Commission con­ amendment to the Kosmetik-Verordnung firmed that, notwithstanding that notifica­ which transferred OHP from the schedule of tion, the procedure followed in every case substances prohibited by virtue of national was the one prescribed by Article 8(2). The law, which is contained in Annex I, PartB, Commission also stated that, although the of the Kosmetik-Verordnung, to the sched­ Scientific Committee was consulted in ule of substances prohibited by virtue of respect of certain of those measures, the Community law contained in Annex I, Part 10 opinion of the latter was not obtained as A.V. regards the proposed ban of OHP. The rea­ son why the Scientific Committee was not consulted in respect of OHP was that nei­ ther the Commission nor a Member State made any request for such a consultation.

(c) The Medicines Directive

15. Article 1(1) of the Twelfth Directive amended Annex II of the Cosmetics Direc­ tive 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 17. Article 1 of the Medicines Directive States were required to ensure that, as from defines a 'proprietary medicinal product' as: 1 January 1991, neither manufacturers nor importers established in the Community place on the market cosmetic products con­ taining 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.

18. Further rules relating to applications for the authorization of proprietary medicinal By Article 2(1), as amended, 11the Directive products were laid down by Council Direc­ 2 applies in particular to proprietary medicinal tive 75/319/EEC of 20 May 1975. 1 Other products for human use intended to be Directives lay down rules regulating such placed on the market in Member States. By matters as classification, labelling and adver­ 3 Article 3, as amended: tising of medicinal products 1 and the har­ monization of application requirements and 1 testing procedures. 4

'No medicinal product may be placed on the market in a Member State unless an authori­ zation has been issued by the competent 19. It appears from the order for reference authority of that Member State.' that, by a judgment of the Oberverwaltungsgericht Hamburg of

Rules governing the application for, and the 12 — Second Council Directive of 20 Mav 1975 on the approxi­ mation of provisions laid down by law. regulation or granting of, such authorizations are laid administrative action relating to proprietary medicinal down by Articles 4 to 10 of the Directive. In products (OJ 1975 L 147, p. 13); last amended by Council Directive 92/27/EEC of 31 March 1992 (cited above in note particular, Article 5, as amended, provides as 4).

follows: 13 — Sec 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 .!), as amended by Council Directive 11 — See Council Directive 89/341/EEC of 3 May 1989 (OJ 89/341/EEC (cited above in note 11) and last amended by 1989L 142, p. 11). Commission Directive 91/507/EEC (OJ 1991 L 270, p. 32).

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 'As regards the meaning of "restoring, cor­ therefore that the Court would, if necessary, recting or modifying physiological func­ be in a position to give relatively detailed tions", it is clear from the aim of health pro­ guidance to the national court on the classi­ tection pursued by the Community fication of Setaderm as a medicinal or cos­ legislature that the phrase must be given a metic product. I now turn to a consideration sufficiently broad interpretation to cover all of that question. substances capable of having an effect on the actual functioning of the body.

Cosmetic and medicinal products

However, that criterion does not serve to include substances such as certain cosmetics 21. The Upjohn case concerned a product which, while having an effect on the human which, like Setaderm, was designed to inhibit body, do not significantly affect the metabo­ the natural onset of baldness in men. The lism and thus do not strictly modify the way product was marketed by The Upjohn Com­ in which it functions.

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22. In the present case there is evidence tion of 5 α-Dihydrotestosterone or inhibit before the Court regarding the actual and its effects, and thereby prevent the loss of purported physiological effects of OHP and hair. In 1982 findings were published which which is therefore relevant to the question indicated that OHP might have such an whether Setaderm is a medicinal product. action when applied locally to the scalp; it The expert report by Professor Dr Walter was suggested that OHP attaches itself to Braun commissioned by the 5 α-Reductase and thereby inhibits the pro Verwaltungsgericht is contained in the duction of 5 α-Dihydrotestosterone.

It 23. From Professor Braun's report it appears cannot be said that such a product does not that it was not until the 1970s that any solid have, or is not intended to have, a significant scientific evidence emerged of the causes of effect on the metabolism: the product pur premature baldness in men. Results were ports 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 15 — The memorandum of the Bundesgesundhcilsanu appears to form the basis of the German Government's grounds for 5 α-Dihydrotestosterone in the presence of the prohibition of OHP given in its notification to the Commission of 16 January 1989, pursuant to Article 12 of 5 α-Reductase (or, alternatively, by means of the Cosmetics Directive. A copy of that notification is an inhibition of the effect of annexed to the German Government's written obser vations. 5 α-Dihydrotestosterone itself).

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me therefore that such a product must fall body, and effects which are purely cosmetic within the definition of 'medicinal product' in the sense of modifying the appearance of contained in Article 1 of the Medicines the body without having any influence on its Directive: see paragraphs 17 and 21 above. inner processes or functions. A product Moreover, as we have seen, it is not material which is used with a view to modifying the to the classification of a product as a medici­ metabolic processes occurring in the scalp, at nal product whether its active ingredient the level of the roots of the hair, is clearly actually has the intended effect. It is suffi­ intended to have a significant effect on the 16 cient if the product, when placed on the mar­ metabolism of that part of the body. It ket, is held out as having such an effect. 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. Fur­ 25. Angelopharm submits that Setaderm thermore, although the list of cosmetic prod­ does not have any effect on the human ucts contained in Annex I to the Cosmetics metabolism and does not strictly speaking Directive is clearly for illustrative purposes modify the way in which it functions, only, it is to be noted that none of the cat­ because its intended effect occurs only in the egories of 'hair care products' mentioned scalp, at the level of the roots of the hair. therein would appear to include a product Angelopharm suggests that, for a substance intended to affect hormonal activity in the to 'significantly affect the metabolism' within tissue of the scalp. the meaning of paragraph 22 of the Court's judgment in Upjohn, it must affect such mat­ ters as the blood, the blood pressure, and the functions of the liver, the kidney or the sexual organs.

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serve cosmetic purposes are to be classified national legislation were held to be invalid, as cosmetic products, rather than as medi­ Angelopharm would still not be entitled to cines, when their main purpose is not to market Setaderm as a cosmetic product. As remedy or alleviate disease, discomfort, we shall see, however, on the view I take the physical injury or pathological complaints. It invalidity of the prohibition has in the event is clear from the Court's subsequent judg­ not been established. I now therefore turn to ment in Upjohn that a classification of a consider what answers are to be given to the product as a cosmetic on the basis of such a questions referred. criterion can no longer be regarded as cor­ rect as a matter of Community law, and that the notion of medicinal product extends to any product which has (or is held out as hav­ ing) a significant effect on the metabolism: see paragraph 21 above. Consideration of the questions referred

31. Angelopharm raises two objections to the validity of the prohibition of OHP con­ tained in the contested provision. In the first 29. In that case, therefore, even if the prohi­ place, Angelopharm suggests that the prohi­ bition of OHP under Community and bition was introduced in breach of essential

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procedural requirements, and in particular in 33. According to the sixth recital to the breach of a requirement to consult the Scien­ Twelfth Directive: tific 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 '... the measures provided for in this Direc­ likelihood has been established that products tive are in accordance with the opinion of containing OHP pose any risk to the health of the consumer. I shall take each of those the Committee on the Adaptation to Techni­ points in turn. cal Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector'.

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34. By a written question the Court invited 36. The United Kingdom Government sug­ Angelopharm, the German and United King­ gests that, if consultation of the Scientific dom Governments and the Commission to Committee were indeed a mandatory submit observations on whether consultation requirement of the procedure laid down by of the Scientific Committee is mandatory in Article 8(2), the words 'at the initiative of the the case of every amendment made under the Commission or of a Member State' would be procedure laid down by Article 8(2), or otiose. That does not however follow. As we whether such a consultation is only required have seen, the Scientific Committee for Cos­ when a request is made by the Commission metology was set up by Commission Deci­ or one of the Member States. Views were sion 78/45/EEC of 19 December 1977, cited 18 also invited on the consequences of any fail­ above in paragraph 11. Article 2(1) of the ure to consult for the validity of the mea­ Decision provides that: sures adopted.

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

Member State. Thus, as Angelopharm points 2. The representative of the Commission out, in the absence of any reference to con­ shall submit to the Committee a draft of sultation 'at the initiative... of a Member the measures to be adopted.... State' it would be unclear whether the proce­ dure provided for by Article 8(2) could be initiated by a Member State as well as by the Commission. Even if consultation were man­ datory, therefore, the reference to 'the initia­ ...'. [my emphasis] tive of the Commission or of a Member State' would not be otiose.

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laid down by Article 10 the Regulatory possesses a wide discretion in deciding Committee must be consulted. It can be seen whether to consult the Scientific Committee, in fact that the intervention of the Regula­ that discretion is not unlimited. tory Committee in the adoption of measures Angelopharm suggests that consultation may under Article 10 serves a different purpose in effect be a mandatory requirement in par­ from the contribution made by the Scientific ticularly complex or difficult cases such as Committee under Article 8(2). The former the present one. Committee forms part of the mechanism of control, by the representatives of the Mem­ ber States, of the exercise by the Commis­ sion of its delegated powers. That mecha­ nism is supplemented by the right given to each Member State to obtain an opinion 41. It seems to me however that, once it is from the Scientific Committee under the accepted that consultation under Article 8(2) procedure laid down by Article 8(2); but it is is not a mandatory requirement, it would be clear that an actual consultation of the Scien­ difficult in the extreme to distinguish cases in tific Committee is not a necessary part of which the opinion of the Committee must be such control where neither the Commission obtained from those in which the Commis­ nor any Member State considers it appropri­ sion retains a discretion in the matter. It is ate. As the United Kingdom pointed out at clear that the purpose of the provision for the hearing, the representatives of the Mem­ consultation is to make available an addi­ ber States on the Regulatory Committee will tional opinion where either a Member State in any case be assisted by their own expert or the Commission considers such advice advisers. Furthermore there are likely to be necessary. If however it is not considered obvious cases in which consultation is clearly necessary to consult the Scientific Commit­ unnecessary: it would be strange therefore if tee, no obligation to consult can be implied. consultation of the Scientific Committee were a mandatory requirement.

Committee which are attached to the Com­ 45. Even if particular products containing a mission's reply to questions of 26 November given substance are classified as medicines it 1992— no separate vote was taken on the may of course still be necessary to prohibit individual measures contained in the pro­ the substance under the Cosmetics Directive, posed Directive, but only on the proposal since certain other products containing the taken as a whole. Angelopharm has not how­ substance may be properly classified as cos­ ever pointed to any provision of Community metics. Indeed, as the United Kingdom Gov­ law which would preclude measures being ernment pointed out at the hearing, a large adopted by such a procedure. There is in number of the substances listed in Annex II particular nothing in the wording of Article of the Cosmetics Directive are used in 10 to suggest that the Regulatory Committee medicinal products. As we have seen how­ cannot adopt its opinion by voting on a draft ever, when a product is classified as a medi­ containing more than one proposed measure. cine it will in any case be subject to the rules In any event, since a Member State which governing medicinal products: see paragraph assents to a draft containing several measures 5 above. It is to be noted in particular that must also be taken to have assented to each the sale of medicinal products, even when measure contained in the draft, it is difficult they have been authorized, is subject to to see how the two procedures could lead to stricter and more detailed requirements and 19 different results. I conclude therefore that controls than is the sale of cosmetics. Angelopharm has not identified any essential procedural requirement which was breached in the adoption of the contested provision.

47. None the less, in considering the validity of the prohibition of OHP under the Cos­ metics Directive, the conclusions reached It appears from the order for reference that above concerning the classification of '11 a-Hydroxyprogesterone' is another Setaderm as a cosmetic or medicinal product name for OHP. should, I think, be borne in mind. Although OHP must by definition be applied exter­ nally when used in a product purporting to be a cosmetic, it will be recalled that the intended effects of such a use include an 49. In Part I of his report Professor Braun action on the hormonal metabolism of the summarizes the events leading to the com­ scalp. As we shall see below, that fact may be missioning of his report and quotes extracts relevant in deciding whether it was justified from the memorandum of the to prohibit the use of OHP in cosmetic Bundesgesundheitsamt of 28 August 1984; it products. will be recalled that a copy of that memoran­ dum was produced by the German Govern­ ment at the request of the Court (see para­ graph 22 above). In Part II Professor Braun explains the methodology he proposes to 48. The Verwaltungsgericht asked Professor adopt and sets out the conceptual and factual Braun to consider the following two ques­ background. Part III summarizes the existing tions: state of research on OHP, referring in par­ ticular to the work of Tamm and his collabo­ rators 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 '1 . Does existing theoretical and empirical effects and side-effects of OHP, and Profes­ knowledge indicate that hormones in sor Braun's concluding evaluation is con­ general or those of the type 11 a- tained in Part V. Hydroxyprogesterone in particular may have harmful effects on the health of the human body even when applied exter­ nally?

particular, possible harmful side-effects can­ order to prohibit a substance under Annex II not be inferred from the fact that some hor­ of the Cosmetics Directive the Commission mones related to OHP, such as progesterone, is required to establish that it may be a risk may have harmful effects, since a substance to health, in contrast to the position under may have the chemical structure of a hor­ the Medicines Directive where it is the appli­ mone without having the same effects. cant for authorization who must establish Indeed, Professor Braun suggests that OHP the safety of the product. Angelopharm sug­ may have no hormonal effects, and in par­ gests that the German Government places ticular that it may not have the advertised undue emphasis on the results of the experi­ effect of stimulating hair growth. ments 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 20 1993, in which the significance of the ani­ 51. The German Government comments on mal experiments carried out by Byrnes is Professor Braun's report as follows. The disputed, and in which Professor Tamm report does not take sufficiently into consid­ refers to more recent clinical trials carried eration the results of the research of Byrnes out on human volunteers both by himself and his collaborators, which gave rise to the and by other teams of researchers. Professor initial doubts regarding the safety of Braun's doubts concerning the efficacy of OHP. The absence of hormonal side-effects OHP are moreover not relevant, since of OHP has not yet been established with Angelopharm claims only that hair loss can the requisite degree of certainty by means of be arrested or reduced, not that it can restore animal experiments. The German Govern­ hair growth to a bald scalp. ment 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 Gov­ ernment, the absence of any reports of harm­ ful side-effects among users is not of any evi­ dential value, given the limited diffusion of Finally, Angelopharm suggests that the effi­ the product and the lack of clinical surveil­ cacy of Setaderm is demonstrated by its own lance. More generally, the report is based on willingness to engage in the present litiga­ a mistaken view of the allocation of the bur­ tion. den of proof and the amount of experimental evidence which would be necessary to dis­ charge that burden.

56. Those conclusions follow in my view from the aims and structure of the Cosmetics 54. As we have seen, in contrast to the Directive. As we have seen, the Directive Medicines Directive the Cosmetics Directive seeks to ensure that products satisfying the does not impose any requirement for a prod­ requirements of the Directive, which may uct to be authorized before it can be sold as include prohibitions and restrictions a cosmetic; on the contrary, all products imposed on the ground of the protection of which satisfy its requirements enjoy a right health, enjoy free circulation within the to be freely marketed under Article 7 of the Community. In the case of a cosmetic prod­ Directive. Thus, while the sale of a medicinal uct there is an initial presumption that it product is forbidden until the product has should enjoy free circulation, because cos­ received specific authorization, the sale of a metic products, unlike medicines, are not cosmetic is permitted unless it has been pro­ primarily intended to affect the functioning hibited or restricted under Articles 4 and 5 of of the body as opposed to its outward the Directive or under the safeguard proce­ appearance. A hair dye, for instance, can ini­ dure of Article 12. tially 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 55. There is therefore no doubt that, under is safe. If a decision is taken, in accordance the Cosmetics Directive, the authorities with the procedures laid down by the Direc­ introducing a prohibition or a restriction on tive, to prohibit the marketing of products a substance used in a cosmetic product must containing such an ingredient, it will be for have grounds for introducing such a provi­ the party challenging the decision to show sion, whether those authorities are a Member that the product is safe. 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 wher­ ever there is reason to believe that the sub­ stance may have an effect on the human 57. Where, as in the present case, the prod­ metabolism. Where in particular a substance uct in question is specifically intended to is intended to have such an effect, it seems to affect the metabolism, the above consider­ me that such grounds are made out. Accord­ ations apply a fortiori. In such a case it is no ingly, where a decision has been taken to longer necessary to identify a possible side

58. In the present case, it is to be noted in particular that, according to the memoran­ dum of the Bundesgesundheitsamt of 60. In support of its submission that the 28 August 1984, OHP belongs to a category Commission would have to be shown to of substances known as 'steroids', a category have committed a manifest error of appraisal, which also contains such highly active hor­ the United Kingdom Government refers to mones as oestrogens and progestogens. The the judgment of the Court in Case principal claim made on behalf of OHP is C-331/88 Fedesa and Others [1990] ECR that, when applied externally, it has some of 1-4023. In that case the Court, after setting the effects of such hormones but none of out the conditions necessary for a measure to 21 their unwanted side-effects. In such cir­ conform to the principle of proportionality, cumstances it seems to me that there can be stated at paragraph 14 of the judgment: no doubt that it is for Angelopharm to show that OHP does indeed have no such unwanted effects.

It is not clear that that statement, which is authorized medicine. Furthermore the stan­ based on the broad political responsibilities dard of proof which Angelopharm would of the legislature in the sphere of the com­ have to meet is a high one: given that OHP mon agricultural policy, can be extended is intended to have effects on the metabo­ without qualification to measures taken in lism, the standard must in my opinion be at other spheres. It is however true that, in pro­ least as onerous as that required to obtain hibiting the sale of products on the ground authorization for a product under the Medi­ of protection of human health pursuant to cines Directive. 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 62. In the case of medicinal products, a sub­ physiological effects even when used as an stantial degree of harmonization of the stan­ ingredient of a cosmetic, it is difficult to see dards and procedures to be applied in estab­ how that discretion could be shown to have lishing the safety of a product is provided by been exceeded. The short answer to Council Directive 75/318/EEC of 20 May Angelopharm's challenge to the validity of 22 1975. If a product containing OHP as its the prohibition might therefore be that, on active ingredient had received authorization the evidence before the Court regarding the as a medicine in at least one Member State, intended effects of OHP, there can be no or had undergone such toxicological and legitimate reason for using OHP as an ingre­ pharmacological tests and clinical trials as dient of a cosmetic as opposed to a medicine. would make it likely to receive such autho­ rization, 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.

apply for such authorization in respect of would not in itself be sufficient to meet stan­ Setaderm, but that it withdrew its application dards similar to those required in the case of when Setaderm was subsequently classified medicinal products by Part 3.II of the Annex as a cosmetic by the Oberverwaltungsgericht to Directive 75/318/EEC, cited above. (It is Hamburg. No documents relating to that to be noted that, even in the case of a sub­ application have been placed as evidence stance which has been shown not to be before the Court. As I have already absorbed into the system when applied observed, even if Setaderm or a similar prod­ locally, single dose toxicity tests on animals uct had been authorized as a medicine in a are still required under paragraph A(1) of Member State, that might not in itself be suf­ Part 3.II: see Part 3.1(2).) It seems to me ficient to demonstrate that OHP may be therefore that the German Government is safely used as an ingredient of a cosmetic. 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 experi­ ments performed by Byrnes and his collabo­ rators. It is of course open to Angelopharm to attempt to refute the conclusions drawn from those experiments by means of better 64. As we have seen, both Angelopharm and experimental data. It is true that there are the Verwaltungsgericht regard the conclu­ further references to previous experimental sions reached by Professor Braun's report as data in the note by Professor Tamm dated sufficient to establish the safety of cosmetic products containing OHP. However, in the 1 March 1993, but it is I think clear that light of the above considerations on the stan­ Angelopharm has not produced the evidence dard of proof which is applicable in the which would be necessary for it to succeed. 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, 65. Finally, I should mention the suggestion namely an article by Kontula and others in made by Angelopharm in its written obser­ Acta Endocrinologica 1975. It appears that vations, according to which the prohibition only one species of animal was used in that of OHP might be held to be disproportion­ experiment, and that the injected doses were ate in that the Commission could have on Professor Braun's own assessment 'rela­ included OHP in Annex III rather than in tively low'. It is not clear what results are Annex II of the Cosmetics Directive. It will considered to be established by that experi­ be recalled that Annex III, Part 1, contains a ment, but it is clear in any event that it list of substances which cosmetic products

69. In my view, the principles laid down in the Foto-Frost and Zuckerfabrik (b) The effect of the prohibition of OHP Süderdithmarschen 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 67. As we have seen, by its first question the grounds which in effect impugn the validity Verwaltungsgericht asks whether a national of the directive. Where in particular the court is prevented from regarding as invalid national provisions in question are necessary a national provision which does nothing to give effect to a Community measure more than implement the provisions of a which was adopted on grounds of the pro­ Community directive. It appears that, in the tection of health, the national provisions can­ absence of such a duty, the not be regarded as invalid on the ground that Verwaltungsgericht would be minded to they are disproportionate to that objective. regard as invalid the national provisions For, if the national provisions could be chal­ implementing the prohibition of cosmetic lenged on such a ground, that would in effect

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71. It is clear, in any event, that a national '... the Member States' obligation arising court may not regard as invalid national from a directive to achieve the result envis­ measures which are necessary to give effect aged by the directive and their duty under to a directive, if the ground of the alleged Article 5 of the Treaty to take all appropriate invalidity is that the measures are dispropor­ measures, whether general or particular, to tionate. It is clear moreover that that obliga­ ensure the fulfilment of that obligation, is tion arises as soon as the period laid down binding on all the authorities of Member for implementation of the directive expires. States including, for matters within their Thus, in the present case, once the periods jurisdiction, the courts.' laid down by Article 2 of the Twelfth Direc­ tive have expired a national court is pre­ cluded from regarding the measures as invalid.

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 72. In its written observations, the Commis­ achieve the result pursued by the latter. Once sion suggests that no such obligation arises the period prescribed by the directive for before the expiry of the period laid down for implementation has expired, that duty is implementation. In my view, however, there

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ANGELOPHARM v HAMBURG

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OPINION OF MR JACOBS — CASE C-212/91

authorities were not intended to implement Member States to allow the sale of such any Community provision, since no such products until the expiry of the periods laid provision prohibiting OHP had yet been down. The purpose of the periods allowed adopted. Accordingly, when the German by Article 2 is clearly to permit, but not to measures were introduced, the German require, Member States to grant their dis­ courts retained any powers they enjoyed tributors a period of grace before bringing under national law to regard the measures as the prohibitions into force. Thus, as soon as invalid. The position was not immediately the Twelfth Directive was adopted, Member affected by the adoption of the Twelfth States were permitted to prohibit the sale of Directive on 20 February 1990. However, it cosmetic products containing OHP. Con­ appears that on 21 March 1990 measures trary to the view of the Commission, there­ were taken to implement in German law the fore, a Member State would not have to rely prohibitions introduced by Article 1(1) of upon the safeguard provisions of Article the Twelfth Directive: see Article 1(3)(b) of 12 of the Cosmetics Directive in order to the Seventeenth Regulation amending the prohibit such sales between the adoption of 23 Kosmetik-Verordnung. By Article 3 of the the Twelfth Directive on 20 February Seventeenth Regulation those measures came 1990 and the expiry of the periods prescribed into force on 31 March 1990. Accordingly, as by Article 2. Before 20 February 1990, on regards the measures in force from that date, the other hand, a national court was not pre­ the German courts were precluded from vented from regarding as invalid any national regarding as invalid the prohibition under measures prohibiting the use of OHP in cos­ national law of the sale of cosmetic products metics; indeed, before that date such mea­ containing OHP. sures would in addition be contrary to Article 7 of the Cosmetics Directive, unless notified by the Member State concerned pur­ suant to Article 12.

(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.

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