C-387/99

COMMISSION v GERMANY

OPINION OF ADVOCATE GENERAL GEELHOED delivered o n 16 M a y 2 0 0 2 1

I — Introduction mate group, without demonstrating that the increased vitamin content or the vitamins or minerals content poses a serious danger to health, the Republic of Austria has failed to fulfil its obligations under Article 28 EC.

1. In Case C-387/99 the Commission requests the Court to declare that by classifying as medicinal products vitamin and mineral preparations which are law- fully produced or marketed in the other Member States where they contain three times more vitamins and minerals than the daily a m o u n t r e c o m m e n d e d by t h e II — T h e legal background Deutsche Gesellschaft für Ernährung (Ger- man Food Association), the Federal Repub- lic of Germany has failed to fulfil its obligations under Article 28 EC (ex Arti- cle 30 of the EC Treaty).

A — Community Law

2. In Case C-150/00 the Commission requests the Court to declare that by classifying vitamin and mineral prepara- 3. Pursuant to Article 28 EC quantitative tions as medicinal products where they import restrictions and all measures having exceed the basic daily amount and, more equivalent effect are prohibited between generally, when they contain vitamins A, D Member States. In accordance with Arti- and K or mineral substances in the Chro- cle 30 EC the provisions of Article 28 EC are not to preclude prohibitions or restric- tions on imports justified, among others, on the grounds of the protection of health and 1 — Original language: Dutch. life of humans.

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States, were designated as medicinal pro- 10. On 8 October 1999 the Commission ducts when they contain over three times brought an action before the Court. By the recommended daily a m o u n t , was orders of 7 April and 10 May 2000 the incompatible with the principle of the free Kingdom of Denmark and the Republic of movement of goods enshrined in Article 28 Finland respectively were granted leave to EC. intervene in support of the forms of order sought by the Federal Republic of Ger- many.

8. The Commission was of the opinion that the practice concerned constituted a trade 11. Written observations from the German barrier that could not be justified in terms Government, the Danish Government, the of public health or the protection of Finnish Government and the European consumers on the basis of Article 30 EC, Commission have been lodged at the Court. since the practice was contrary to the The German Government and the Eur- principle of proportionality. The German opean Commission expounded their argu- practice did not take into account the fact ments at the hearing of 21 February 2002. that when amounts are increased the harmfulness threshold for vitamins is not reached at the same rate for all vitamins. The Commission maintains that such a view, whereby the strictest standard is applied to all vitamins, is disproportionate to the goal of protecting human health. Case C-150/00

13. In letters dated 15 January and 18 Feb- 15. On 19 April 2000 the Commission ruary 1999 respectively, the Austrian Gov- brought an action before the Court. By ernment submitted a list that serves as the order of 27 October 2000 the Kingdom of guideline for applicants in notification Denmark and the Republic of Finland were submissions. The list also aids the compe- granted leave to intervene in support of the tent authorities in the assessment proce- form of order sought by the Republic of dure. The Austrian Government states that Austria. this list sets out a threshold limit for each individual vitamin, namely the recom- mended daily amount, above which a product containing this substance would be considered a medicinal product. If the vitamin content is below the threshold then 16. Written observations were submitted the product is considered to be a foodstuff. by the Austrian, Danish and Finnish Gov- In the event that the threshold limit is ernments and by the European Commis- exceeded it is the applicant's duty to sion. The oral proceedings in this case took demonstrate that a particular vitamin pre- place on 7 March 2002. paration does not present any danger to health. The Austrian Government states that products containing vitamins A, D and/or K are classified as medicinal pro- ducts because of the risks attached to overdosing. The Austrian Government also points out that the threshold limits on the IV — Arguments of the parties list vary according to the vitamins and the amounts indicated. Furthermore, the basic daily amount serves only as a delimitation criterion. Case C-387/99

18. Among other things the Commission with vitamins soluble in fat than with those refers to the paragraphs in which the Court soluble in water. The Court also stated that states that in general vitamins may not be in particular high dose vitamins appear to regarded as medicinal products when they represent a real danger to health. According are consumed in small quantities, inasmuch to the Commission, to regard all vitamins in as vitamins are usually defined as sub- global/abstract terms, in such a way as stances which, in minute quantities, form necessarily to apply the strictest criterion, is an essential part of the daily diet and are to go beyond 'what is necessary' in order to indispensable for the proper functioning of achieve the goal of health protection as the body. 3 In the event that vitamin or recognised under Community law. multivitamin preparations are used for therapeutic purposes, usually in high amounts, then they will of course be classified as medicinal products. The Court ruled, in the case concerned, that the classification of a vitamin as a medicinal product must be carried out case by case, having regard to the pharmacological prop- erties of each such vitamin to the extent to 20. On the basis of the above the Commis- which they have been established in the sion concludes that the practice followed by present state of scientific knowledge. 4 the German administrative authorities and courts with regard to vitamin and mineral preparations is incompatible with Article 28 EC.

22. With regard to the distinction between continue to exist. 8 In these circumstances, it medicinal products and foodstuffs the Ger- is for the national authorities to determine, man Government points out that according subject to review by the courts, for each to Article 1(2), first subparagraph, of product, whether or not it constitutes a Directive 65/65/EEC 6 medicinal product medicinal product. The German Govern- means 'any substance or combination of ment further asserts that according to the substances presented for treating or pre- settled case-law of the Court the fact that a venting disease in human beings or ani- product is qualified as being a foodstuff in mals', and according to the second subpar- one Member State does not preclude its agraph 'any substance or combination of being treated as a medicinal product in the substances which may be administered to another Member State if it possesses the human beings or animals with a view to relevant characteristics. 9 making a medical diagnosis or to restoring, correcting or modifying physiological func- tions in human beings or in animals' are likewise to be considered medicinal pro- ducts. Furthermore, the German Govern- ment notes that the Court has already stated that the aforementioned directive provides two definitions of the term med- icinal product: one definition 'by virtue of its presentation' and one definition 'by 24. The German Government draws atten- virtue of its function'. 7A product is a tion to the fact that in an action for failure medicinal product if it falls under either one to fulfil obligations, the burden of proof lies of these definitions. According to the Ger- with the Commission, who must demon- man Government it follows from this that strate that in that particular case a Member the classification as medicinal product is State has wrongly classified a product as a not only designed to protect public health medicinal product. The German Govern- but also to protect the consumer. ment considers that the Commission has not proven that the German authorities exceeded their power of assessment, in classifying the vitamin and mineral pre- parations as medicinal products. The Com- mission has simply asserted that the vitamin and mineral preparations were not classi- fied as medicinal products in other Member 23. The German Government observes that States, without demonstrating that the the Court has also stated that, so long as manufacture and marketing of these pro- harmonisation of the measures necessary to ducts in the other Member States was legal. ensure the protection of health is not In addition the Commission has not indi- complete, differences in the classification cated the dosage above which a product is of products as between Member States may considered a medicinal product nor the dosage above which vitamin and mineral preparations are a danger to health. 6 — Council Directive of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, OJ, English Special Edition 1965-66(I), p. 24. 8 — See among others Case C-290/90 Commission v Germany 7 —See among others Case C-369/88 Delattre [19911 ECR [1992] ECR I-3317. I-1487. 9 — Delattre, cited in footnote 7.

26. Furthermore, the German Government is of the opinion that the rule concerning the tripling of the daily amount is justified on the basis of the protection of the consumer, because vitamin and mineral preparations can be classified as medicinal products by virtue of their presentation or by virtue of their function. In this context 29. According to the Commission the Ger- the German Government refers to Van man Government has not justified the rule Beimekom 10 and Glob-Sped. 1 1 In the concerning the tripling of the daily amount latter judgment it was decided that a by demonstrating that the aforementioned product with a high vitamin C content vitamins constitute a health risk on the must be classified as a medicinal product. basis of their specific pharmacological properties at certain concentrations. A mere statement that the rule concerned is not the 10 — Cited in footnote 2. only criterion used for the classification as 11 — Case C-328/97 [1998] LCR I-8357. medicinal product is insufficient.

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OPINION OF MR GEELHEOD — CASES C-387/99 AND C-150/00

Case C-150/00 admissible if the national rule is propor- tionate to the aim in view. If a Member State has a choice between various mea- sures to attain the same objective it should choose the means which least restricts the free movement of goods. 13

13 — The Commission refers to Case 178/84 Commission v 12 — Case 21/84 [1985] ECR 1355. Germany [1987] ECR 1227.

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evidence of harmlessness, because in the demonstrate in each case that their rules are absence of critical limits established by the necessary to give effective protection to the scientific committees, it is the Member State interests referred to in Article 30 EC and, in that must prove that higher concentrations particular, to show that the marketing of pose a threat to health. the product in question creates a serious risk to public health. According to the Austrian Government this does not mean that vitamin and mineral preparations may be classified as medicinal products only 33. The Commission also objects to the when they pose a serious health risk. It fact that under the Austrian practice pro- further adds that it would appear from the ducts that contain vitamins A, D or K or judgment cited that in view of the uncer- mineral substances from the Chromate tainties inherent in scientific assessment, a group are automatically classified as med- national rule applying the procedures fore- icinal products, without it being demon- seen in Directive 65/65 to vitamin or strated that this classification is justified in mineral preparations presented in a phar- terms of health protection. maceutical form or in high concentrations is in principle justified in terms of the protec- tion of human health within the meaning of Article 30 EC.

37. I shall deal with the observations submitted in the present cases by the Danish and Finnish Governments together, since the arguments of both Governments in the two cases are largely the same. 40. With regard to the distinction between medicinal products and food supplements, the Danish Government also refers to Directive 65/65. 17 The Danish Government states that it would appear from the settled 38. The Danish Government observes that case-law of the Court that the 'presentation' in Denmark a provision exists that is criterion used in the directive is designed to similar to the rules at issue regarding the catch not only medicinal products having a tripling of the daily amount and the basic genuine therapeutic or medical effect but daily amount. In the same way as the also those which are not sufficiently effec- German and Austrian rules, the Danish tive, or do not have the effect which their legislation is aimed at protecting the con- presentation might lead to expect, in order sumer from harmful effects of high levels of to preserve consumers not only from vitamins and minerals in food supplements. harmful or toxic medicinal products as The Danish Government points out that it such, but also from a variety of products is generally recognised that an overdose of used instead of the proper remedies. 1 8 both water and fat soluble vitamins can Consequently a product that is expressly have harmful effects. represented or recommended as having therapeutic or prophylactic properties should be considered to be a medicinal product 'by virtue of its presentation', even when no actual therapeutic effect is known.

4 1 . Referring to Van Bennekom 19 the 43. The Finnish Government argues that it Danish Government states that it is impos- is for the Member States to lay down rules sible in the present state of scientific- regarding the maximum permitted levels of knowledge to determine whether the criter- vitamins and minerals in foodstuffs, in view ion of concentration alone is always suffi- of the fact that no Community provisions cient in order to be able to establish exist in that area. Consequently, the Finnish whether a vitamin preparation constitutes Government considers that in the present a medicinal product. Still less is it possible cases the maximum limits laid down for to specify the level of concentration above vitamins and minerals do not conflict with which a vitamin preparation falls within the Community law. definition of a medicinal product. It is apparent from the settled case-law of the Court 20 that the fact that a product is not considered to be a medicinal product in one particular Member State is not relevant in determining whether or not the product concerned can be classified as a medicinal product. In this context the Danish Govern- ment refers to the wide discretion of the Member States with regard to the degree of 44. The Finnish Government states that in protection they wish to provide for the the majority of Member States these max- health and the life of humans. imum limits are established with the coop- eration of food scientists and medical experts, taking into account both the pharmacological effects of a particular substance and the protection of consumer health. In these circumstances it is up to the Member States to determine in specific- cases whether certain vitamins and mineral preparations should be classified as medic- inal products within the meaning of Direc- 42. Finally, the Danish Government states tive 65/65. that the rules regarding the tripling of the daily amount and the basic daily amount are in conformity with the principle of proportionality. The Danish Government considers the burden of proof, which requires that the Member States demon- strate that the national rule regarding maximum limits does not go further than what is necessary to protect human health, to be lower as a result of the scientific 45. The Finnish Government goes on to uncertainty regarding the level at which a state that even if Article 28 EC were threat to human health arises. applicable, the German and Austrian prac- tices are justified in terms of the protection of consumers and of health. Inasmuch as 19 — Cited in footnote 2. the incorrect use of vitamins and minerals 20 — Delattre, cited in footnote 7. can pose a threat to public health, vitamin

Introduction 48. In both cases the Commission's objec- tion relates to practices followed by the administrative authorities and courts. It is settled case-law that these practices may also be the subject of an infringement procedure. 21 In the present cases I believe 46. The cases at issue concern the compat- that the Commission has stated the object ibility with Articles 28 and 30 EC of of the procedure in sufficiently clear terms. German and Austrian administrative prac- The cases do not concern a specific vitamin tices applied to vitamin or mineral enriched or mineral preparation but rather a practice food supplements. The public health inter- followed by the administrative authorities ests presented by these cases are not at and courts whereby food supplements are issue. The criticism of the Commission is 'automatically' deemed to be medicinal essentially directed at the manner in which products if a certain limit is exceeded, the Germans and Austrians have set stan- thereby ignoring the fact that the harmful dards. effects (or the therapeutic aspects) which can occur when an overdose is taken, vary from one vitamin or mineral preparation to another. It is also settled case-law that in proceedings for failure to fulfil an obliga- tion, it is incumbent upon the Commission Admissibility to prove the allegation that the obligation has not been fulfilled. 22 Whether the Commission has sufficiently demonstrated the alleged failure is an issue that should be dealt with in the consideration of the substance of the case. 47. Before going into the substance of the cases it is first necessary to consider the admissibility aspect. The German Govern- 21 — Commission v France, cited in footnote 12. ment disputes the admissibility of the 22 — See for example Case 96/81 Commission v Netherlands Commission's action. The German Govern- [1982] ECR 1791; in Case C-159/94 Commission v France [1997] ECR I-5815; and Case C-55/99 Commission v ment has argued that the Commission's France [2000] ECR I-11499.

52. A proposal exists for a directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supple- ments, 2 4 which, although it is in an 50. Both cases concern vitamin and advanced stage of the adoption process, 25 mineral preparations that are lawfully has not yet been adopted. The first pre- marketed as food supplements elsewhere condition is thus met. The German and in the Community. Nor is it disputed that a Austrian Governments have indicated that great variety of vitamins and minerals are Community legislation (Directive 65/65) covered by a general standard in Germany does exist in the area of medicinal products. and Austria. A recommended daily amount I shall return to this aspect later in my is applied to each vitamin and mineral. The conclusions. I shall limit myself here to general standard then states that this value pointing out that this directive does not may not be exceeded by a factor of three or define what should be classified as a a factor of one respectively. As a result medicinal product and what as a food preparations that are lawfully marketed as supplement and that therefore, in the foodstuffs elsewhere in the Community may not be marketed as such in Germany and Austria. This results in a quantitative 23 — Sealed case-law, see among others Case 104/75 De Peijper import restriction within the meaning of [1976] ECR 613, paragraphs 16 and 17; Sandoz (cited in footnote 5), paragraph 18; Case 247/84 Motte [1985] Article 28 EC. However, Article 30 EC ECR 3887, paragraph 23; Case 304/84 Muller and Others provides a ground for justification for [1986] ECR 1511, paragraph 23; Commission v Germany (cited in footnote 13), paragraphs 28 and 44; Case C-42/90 national measures that aim to protect Bellon [1990] ECR I-4863, paragraph 13. public health. In this regard a number of 24 — COM(2000) 222 final (OJ 2000 C 311, p. 207). 25 — On 21 February 2002 the European Parliament approved preconditions must be met. the proposal at its second reading.

56. A simple general rule has the advantage that it is transparent for the sellers and can be easily carried out and enforced by the public authorities. The disadvantage of such a rule is that it can exclude products 54. Both the Austrian and German legisla- from being marketed as foodstuffs, without tion and practice establish general upper it being established that they are, or could limits for the presence of vitamins and be, a real danger to health. Both the minerals in food supplements and provide German administrative practice and the that preparations which exceed this upper Austrian legislation have such far-reaching limit are to be classified as medicinal consequences, since they both classify pro- ducts as medicinal products, and therefore exclude them from being foodstuffs, despite 26 — I have already expressed my opinion that the principle of the fact that such a classification does not proportionality is not a static concept, but should rattier be necessarily follow from the medicinal pro- examined in the light of the intended objective, in my Opinion in Case C-121/00 Hahn [2002] ECR I-9193 ducts directive.

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57. The next question that arises is whether case as to whether a vitamin preparation is a comparable level of health protection can to be classified as a medicinal product be offered by more appropriate means, (within the meaning of the second part of without this having such serious conse- the definition in Directive 65/65). 2 8 quences for the free movement of goods. The answer is in the affirmative as shall be demonstrated below.

28 — For further detail o n t h i s aspect see point 22 o f this opinion. 27 — Cited in footnote 2. 29 — C i t e d in footnote 5.

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OPINION OF M R GEELHEOD — CASES C-387/99 AND C-150/00

national authorities to demonstrate in each the Member States are still obliged to case that their rules are necessary and, in demonstrate, where possible, on a case by particular, to show that the marketing of case basis, which standards may justifiably the product in question creates a serious be applied to the dosage in order to protect risk to public health. 30 public health.

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66. I do not consider the Austrian Govern- 68. Vitamin and mineral preparations are ment's argument that the product can at often presented in the form of tablets or least still be marketed as a medicinal capsules. However, it should not be product to be valid. In fact, for traders, assumed on the basis of this fact alone that the classification as a medicinal product or they are medicinal products. Since, if this as a foodstuff has consequences for their were the case, certain foodstuffs that are market behaviour. The sale, distribution traditionally presented in a similar form to and advertising of medicinal products are pharmaceutical products would also be subject to far stricter rules than that of covered. 32In this respect, as the Bundes- foodstuffs. Furthermore, in the context of gerichtshof has also remarked, it is the Directive 65/65 to obtain approval as a therapeutic or prophylactic efficacy that is medicinal product expensive testing is of primary i m p o r t a n c e . " Moreover the necessary. According to the German prac- consumer can be informed of the recom- tice, it is even possible that vitamin and mended daily amount, the maximum, the mineral preparations cannot be marketed as aim and the use of the food supplement via medicinal products because they have no labelling or the insert leaflet. therapeutic efficacy.

69. With regard to the customs classifica- tion and the argument of the German Government based on Glob-Sped 34 the following reference in that judgment seems to me to be relevant:

(other than that relating specifically to 72. Finally, on this point, I would state that classification in the combined nomen- the Danish Government's opinion that the clature) or in the national legislation of burden of proof for the Member States the Member States, or in any pharma- should be more limited in the event of copoeia, is not the deciding factor in so scientific uncertainty regarding the level at far as its classification in this chapter is which the risk of harm arises, and that concerned."' consequently Member States are within their rights in adopting general and strict approval standards, cannot be accepted as such. This uncertainty still allows for the possibility of a differentiated approach with regard to the maximum levels justified per vitamin or group of vitamins in the light of those uncertainties. 70. I am of the opinion that it can be deduced from this that the classification of a product as a medicinal product for customs purposes does not necessarily mean that a similar product should also be classified as a medicinal product within the meaning of the medicinal products directive.

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tion that contains vitamin A or D is to be 75. In any event, the Court permits differ- classified as a medicinal product only if the ences with regard to the level of protection, preparation contains in excess of the single provided the measure adopted to protect recommended daily amount. the interest at stake is appropriate and respects the principle of proportionality. As already observed above, neither of the regulations takes into account the fact that when amounts are increased the harmful- 74. From this comparison it is apparent ness threshold per vitamin or mineral is that the Austrian regulation and practice different. In both cases this is the aspect to are stricter or more restrictive than the which the Commission objects. By not German. It is true that the Austrian taking any account of this, the German Government has asserted that rebuttal is and Austrian measures go further than is possible, however it has not been able to necessary in order to protect the public demonstrate that this is anything more than health interest. a formal possibility.

Conclusion

76. Therefore, I propose that the Court should:

In Case C-387/99

— declare that, by classifying vitamin and mineral preparations as medicinal products where they exceed the basic daily amount and more generally, without demonstrating that the increased vitamin content or the vitamins or minerals content poses a serious danger to health, the Republic of Austria has failed to fulfil its obligations under Article 28 EC;

— order the Republic of Austria to pay the costs.

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