Commission of the European Communities v Federal Republic of Germany.
Date: 2004-04-29
28. The German Government states that the Commission has not indicated the dosage above which a distinction could be made between a food supplement and a medicinal product and that cer tain Member States have adopted stricter recommendations than those of the German Food Association. It contends that it may not be inferred from scientific knowledge that the triple amount rule is wrong from the dietary or health point of view.
42. The case-law of the Court (see, to that effect, Case 21/84 Commission v France  [1985] ECR 1355, paragraphs 13 and 15; Case C-187/96 Commission  v Greece  [1998] ECR I-1095, paragraph 23; and Case C-185/96 Commission  v Greece [1998] ECR I-6601, paragraph 35) shows that an administrative practice can be the subject-matter of an action for failure to fulfil obligations when it is, to some degree, of a consistent and general nature.
50. Accordingly, if a product produced industrially comes within the definition of medicinal product in Article 1(2) of Directive 65/65, the obligation on the importer of that product to obtain a marketing authorisation in accordance with that directive prior to marketing it in the Member State of importation cannot in any event constitute a restriction on trade between Member States prohibited by Article 30 of the Treaty (see, to that effect, Case C-322/01 Deutscher Apothekerverband  [2003] ECR I-0000, paragraphs 48, 52 and 53).
51. Furthermore, although the essential purpose of Directive 65/65 is to remove obstacles to trade in medicinal products within the Community and although for that purpose Article 1 gives a definition of medicinal products, it nevertheless constitutes merely a first stage in the harmonisation of national legislation on the production and distribution of pharmaceutical products (see, in particular, Commission v Germany , cited above, paragraph 15).
52. As Community law stands, so long as harmonisation of the measures necessary to ensure the protection of health is not more complete, it is difficult to avoid the existence of differences in the classification of products as between Member States in the context of Directive 65/65 (see, inter alia, Case C-201/96 LTM [1997] ECR I-6147, paragraph 24, and Case C-270/96 Laboratoires Sarget [1998] ECR I-1121, paragraph 23).
53. The fact therefore that a product is classified as a foodstuff in another Member State cannot prevent its being classified as a medicinal product in the Member State of importation if it displays the characteristics of such a product (see, inter alia, Delattre , paragraph 27; LTM , paragraph 24; and Laboratoires Sarget , paragraph 23, all cited above).
56. In so far as vitamins are usually defined as substances which, in minute quantities, form an essential part of the daily diet and are indispensable for the proper functioning of the body, they cannot, as a general rule, be regarded as medicinal products when they are consumed in small quantities. Similarly, it is a fact that vitamin preparations are sometimes used, generally in large doses, for therapeutic purposes in combating certain diseases other than those of which the morbid cause is a vitamin deficiency. In such cases, it is beyond dispute that those vitamin preparations constitute medicinal products ( Van Bennekom , cited above, paragraphs 26 and 27).
57. In those circumstances, and in accordance with settled case-law, to determine whether vitamin preparations should be classified as medicinal products within the meaning of Directive 65/65, the national authorities, acting under the control of the court, must work on a case-by-case basis, having regard to all of their characteristics, in particular their composition, their pharmacological properties – to the extent to which they can be established in the present state of scientific knowledge – the manner in which they are used, the extent of their distribution, their familiarity to consumers and the risks which their use may entail (see, inter alia, Van Bennekom , cited above, paragraph 29; Case C-60/89 Monteil and Samanni [1991] ECR I-1547, paragraph 29; Case C-112/89 Upjohn [1991] ECR I‑1703, paragraph 23; and Commission v Germany , cited above, paragraph 17).
58. Accordingly, a risk to public health is only one aspect of the product which must be taken into consideration by the competent national authorities. It is obvious that a product which does not pose a real risk to health can nevertheless have an effect on the functioning of the body. To classify a product as a ‘function’ medicinal product, those authorities must ascertain that it is intended to restore, correct or modify physiological functions and that it may thus have an effect on health in general ( Upjohn , cited above, paragraph 17).
64. The prohibition on measures having an effect equivalent to quantitative restrictions laid down in Article 30 of the Treaty relates to all rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, inter alia, Case 8/74 Dassonville [1974] ECR 837, paragraph 5, and Case C-192/01 Commission v Denmark [2003] ECR I‑0000, paragraph 39).
66. The Court has already ruled that a product which is not a medicinal product within the meaning of the provisions of Article 1(2) of Directive 65/65 may, subject to Article 30 et seq. of the Treaty concerning products imported from other Member States, be subject in the domestic law of a Member State to the rules governing medicinal products ( Van Bennekom , cited above, paragraphs 15, 30, 31 and 38; Case 35/85 Tissier  [1986] ECR 1207, paragraph 22; and Case C-219/91 Ter Voort  [1992] ECR I-5485, paragraph 42).
68. In that respect, it is for the Member States, in the absence of harmonisation and in so far as there are uncertainties in the present state of scientific research, to decide on the degree of protection of the health and life of humans they intend to ensure and on the requirement for an authorisation prior to placing foodstuffs on the market, having regard, however, to the requirements of the free movement of goods within the Community ( Sandoz , cited above, paragraph 16; Van Bennekom , cited above, paragraph 37; Commission  v Denmark , cited above, paragraph 42; and Case C-24/00 Commission  v France  [2004] ECR I-0000, paragraph 49).
69. That discretion relating to the protection of public health is particularly important when it is established that there are uncertainties in the present state of scientific research into certain substances, such as vitamins which are not as a general rule harmful in themselves but may have particular harmful effects solely if taken to excess as part of a general diet, the composition of which is unforeseeable and cannot be monitored ( Sandoz , paragraph 17; Commission  v Denmark , paragraph 43; and Commission  v France , paragraph 50, all cited above).
70. Community law does not therefore, in principle, preclude a Member State from prohibiting, save with prior authorisation, the marketing of foodstuffs incorporating nutrients, such as vitamins other than those whose addition is lawful under Community legislation ( Commission  v Denmark , paragraph 44, and Commission  v France , paragraph 51, both cited above).
71. However, in exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of intra-Community trade (see Sandoz , paragraph 18; Van Bennekom , paragraph 39; Commission  v Denmark , paragraph 45; and Commission  v France , paragraph 52, all cited above).
72. Furthermore, since Article 36 of the Treaty provides for an exception, to be interpreted strictly, to the rule of free movement of goods within the Community, it is for the national authorities which invoke it to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in that provision and, in particular, that the marketing of the products in question poses a real risk to public health ( Sandoz , paragraph 22; Van Bennekom , paragraph 40; Commission  v Denmark , paragraph 46; and Commission  v France , paragraph 53, all cited above).
79. Accordingly, the automatic nature of that practice does not make it possible to identify and assess a real risk to public health, which requires a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question could entail (see, to that effect, Commission v Denmark , cited above, paragraph 56).