Commission of the European Communities v Federal Republic of Germany.
Date: 2007-11-15
35. It follows that if a product produced industrially comes within the definition of medicinal product in Article 1(2) of Directive 2001/83, 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 28 EC (see, to that effect, Case C-150/00 Commission  v Austria  [2003] ECR I-3887, paragraph 57).
36. Furthermore,  although the essential purpose of Directive 2001/83 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 such products (see, to that effect, Commission v Austria , paragraph 58).
37. In those circumstances, 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 medicinal products or foodstuffs between Member States. Thus, the fact that a product is classified as a foodstuff in another Member State cannot prevent it from being classified as a medicinal product in the Member State of importation, if it displays the characteristics of such a product (see HLH Warenvertrieb and Orthica , paragraph 56).
38. The fact remains that a product which satisfies the definition of ‘medicinal product’ within the meaning of Directive 2001/83 must be held to be a medicinal product and be made subject to the corresponding rules even if it comes within the scope of other, less stringent Community rules (see, to that effect, Case C-219/91 Ter Voort  [1992] I‑5485, paragraph 19 and the case-law cited).
41. The directive thus gives two definitions of medicinal product, one ‘by presentation’ and one ‘by function’. A product is a medicinal product if it falls within either of those definitions ( HLH Warenvertrieb and Orthica , paragraph 49).
43. According to settled case-law, the term ‘presentation’ of a product must be interpreted broadly. It must be recalled, in that connection, that by basing its arguments on the criterion of the ‘presentation’ of the product, Directive 2001/83 intends to cover not only medicinal products having a genuine therapeutic or medical effect, but also those which are not sufficiently effective or do not have the effect which consumers would be entitled to expect from the way in which they are presented. The directive thereby intends to protect the consumer not only from harmful or toxic medicinal products, but also from a variety of products used instead of the proper remedies ( van Bennekom , paragraph 17).
44. In that context, a product is ‘presented for treating or preventing disease’ within the meaning of Directive 2001/83 when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation (see, to that effect, van Bennekom , paragraph 18, and Monteil and Samanni , paragraph 23).
46. A product is also ‘presented for treating or preventing disease’ whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties in question (see, to that effect, van Bennekom , paragraph 18, and Monteil and Samanni , paragraph 23).
47. In that regard, account must be taken of the attitude of an averagely well-informed consumer, in whom the form given to a product may inspire particular confidence similar to that normally inspired in him by proprietary medicinal products, having regard to the safeguards normally associated with their manufacture and marketing. Although the external form given to the product may serve as strong evidence of its classification as a medicinal product by presentation, the ‘form’ must be taken to mean not only the form of the product itself but also that of its packaging, which may, for reasons of marketing policy, tend to make it resemble a medicinal product (see, to that effect, van Bennekom , paragraph 19, and Monteil and Samanni , paragraph 24).
52. However, it must be recalled that, according to settle case-law, the external form given to a product, although it may serve as strong evidence of the seller's or manufacturer's intention to market that product as a medicinal product, cannot be the sole or conclusive evidence, since otherwise certain food products which are traditionally presented in a similar form to medicinal products would also be covered (see, to that effect, van Bennekom , paragraph 19, and Delattre , paragraph 38).
55. For the purposes of determining whether a product falls within the definition of a medicinal product by function within the meaning of Directive 2001/83, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail ( HLH Warenvertrieb and Orthica , paragraph 51).
59. The pharmacological properties of a product are the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive 2001/83, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings ( HLH Warenvertrieb and Orthica , paragraph 52).
60. Although, as the Advocate General observed in paragraph 58 of her Opinion, that definition is broad enough to include products which, although they are capable of having an effect on bodily functions have in fact another purpose, that criterion must not lead to the classification as a medicinal product by function of substances 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 ( Upjohn , paragraph 22).
63. Furthermore, although only the provisions of Community law specific to medicinal products apply to a product which satisfies the conditions for classification a medicinal product,  even if it comes within the scope of other, less stringent Community rules (see, to that effect, Delattre , paragraph 22, Monteil and Samanni , paragraph 17, Ter Voort , paragraph 19, and HLH Warenvertrieb and Orthica , paragraph 43 ), it must be stated, as is shown by a reading of Article 1(2) of Directive 2001/83 in conjunction with Article 2 of Directive 2002/46, that the physiological effect is not specific to medicinal products but is also among the criteria used for the definition of food supplements.
69. Finally, and contrary to the Federal Republic of Germany's submissions, the fact that ingesting the product concerned could give rise to risks to health is not an indication that it is pharmacologically effective. It is clear from the case-law that the risk to health, although it must be taken into consideration in the classification of a product as a medicinal product by function, is none the less an autonomous factor ( HLH Warenvertrieb and Orthica , paragraph 53).
80. The prohibition on measures having equivalent effect to quantitative restrictions, set out in Article 28 EC, covers all measures which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular, Case 8/74 Dassonville  [1974] ECR 837, paragraph 5, and Commission  v Austria , paragraph 81).
81. In this case, the Federal Republic of Germany's decision creates an obstacle to intra-Community trade in so far as the products concerned, legally marketed in other Member State as a foodstuff, can be marketed in Germany only after having been subjected to the authorisation procedure for the placing on the market of a medicinal product.
83. Whilst Article 30 EC allows the maintenance of restrictions on the free movement of goods justified on grounds of the protection of the health and life of humans, which are fundamental requirements recognised by Community law, it must be recalled that that provision cannot be applied where Community directives provide for harmonisation of the measures necessary to achieve the specific objective which would be furthered by reliance upon it (see, to that effect, Case C-102/96 Commission  v Germany [1998] ECR I‑6871, paragraph 21).
84. In this case, it is not necessary to examine whether the product concerned may be classified as a food supplement within the meaning of Article 2 of Directive 2002/46 or as a foodstuff within the meaning of Article 2 of Regulation No 178/2002. It is sufficient to hold that, according to Article 11(2) of Directive 2002/46 and Article 14(9) of Regulation No 178/2002, in the absence of specific Community rules laid down in those provisions, national rules may be applied without prejudice to the provisions of the Treaty.
86. In that connection, it must be recalled that it is for the Member States, in the absence of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, to decide on their intended level of protection of human health and life and on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements of the free movement of goods within the Community (Case 174/82 Sandoz [1983] ECR 2445, paragraph 16; van Bennekom , paragraph 37; and Joined Cases C-158/04 and C-159/04 Alfa Vita Vassilipoulos and Carrefour-Marinopoulos  [2006] ECR I-8135, paragraph 21).
87.  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; Case C-192/01 Commission  v Denmark  [2003] ECR I‑9693, paragraph 45; and Case C-24/00 Commission  v France  [2004] ECR I-1277, paragraph 52).
88.  Furthermore, since Article 30 EC 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 for public health ( Sandoz , paragraph 22; van Bennekom , paragraph 40; Commission  v Denmark , paragraph 46; and Commission  v France , paragraph 53).
89.  Although, as was noted in paragraph 86 of this judgment, Community law does not, in principle, preclude a system of prior authorisation, it must however be stated that the issue of a marketing authorisation under Article 8 of Directive 2001/83 is subject to particularly strict requirements.
90. In those circumstances, the obligation to obtain a marketing authorisation for a medicinal product before being able to market the disputed product on German territory may be regarded as in accordance with the principle of proportionality only if it is actually necessary to safeguard public health.
91. Such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment of the risk alleged by the Member State invoking Article 30 EC (see, to that effect, Commission  v Denmark , paragraph 47, and Commission v France , paragraph 54).
95. Furthermore, the Member State, instead of making the product concerned subject to such a procedure, could have prescribed suitable labelling warning consumers of the potential risks related to taking this product. The protection of public health would thus have been ensured without such serious restrictions on the free movement of goods (see, to that effect, Case C-17/93 van der Veldt  [1994] ECR I-3537, paragraph 19).