Commission of the European Communities v Kingdom of Spain.
Date: 2009-03-05
54. It is settled case-law that an administrative practice can be made the object of an action for failure to fulfil obligations when it is, to some degree, of a consistent and general nature (see, inter alia, Case C‑135/05 Commission  v Italy  [2007] ECR I‑3475, paragraph 21).
68. It follows that, if a product manufactured 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 (Case C‑319/05 Commission  v Germany  [2007] ECR I‑9811, paragraph 35).
69. Moreover, as the harmonisation of national legislation in relation to the production and distribution of medicinal products currently stands, 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 Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertrieb and Orthica  [2005] ECR I‑5141, paragraph 56, and Commission  v Germany , paragraphs 36 and 37).
72. In order to determine whether a product falls under the definition of medicinal product by function within the meaning of Directive 2001/83, the national authorities, subject to review by 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, immunological and/or metabolic 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; Commission  v Germany , paragraph 55, and Case C‑140/07 Hecht-Pharma  [2009] ECR I‑0000, paragraph 32).
75. It is possible that, having regard, in particular, to the small amount of the active substance contained in it and/or the manner in which it is used, a product based on medicinal herbs will have no effect on physiological functions or that its effects will not suffice for it to be a medicinal product by function (see, by analogy, as regards preparations containing vitamins or minerals, Commission  v Austria , paragraph 63; see also, to that effect, Hecht-Pharma , paragraph 42). In that regard, the Court has held that 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 should not be classified as medicinal products by function (see Commission  v Germany , paragraph 60, and Hecht-Pharma , paragraph 41).
79. Article 2(2) of Directive 2001/83 must be interpreted as meaning that that directive does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility ( Hecht-Pharma , paragraph 29). Moreover, given the systematic nature of the Spanish administrative practice, it is possible that products based on medicinal herbs other than those listed in the annex to the 1973 Order will be classified as medicinal products by function although that is clearly not the case.
82. 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; Case C‑192/01 Commission  v Denmark  [2003] ECR I‑9693, paragraph 39; Commission  v France , paragraph 22; and Commission v Germany , paragraph 80).
83. In the present case, the Spanish administrative practice creates an obstacle to intra-Community trade in so far as a product based on medicinal herbs not listed in the annex to the 1973 Order, lawfully produced and/or marketed in another Member State as a food supplement or dietary product, can be marketed in Spain only after going through the marketing authorisation procedure (see, by analogy, Commission  v Austria , paragraph 82, and Commission  v Germany , paragraph 81).
86. In accordance with the Court’s case-law, 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 the level of protection of human health and life they wish to ensure 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 (see Commission  v Denmark , paragraph 42; Commission  v France , paragraph 49; and Commission  v Germany , paragraph 86).
87. It follows that Community law does not therefore, in principle, preclude a Member State from prohibiting, unless there is prior authorisation, the marketing of foodstuffs to which nutrients, such as vitamins or minerals other than those whose use is lawful under Community legislation, have been added ( Commission  v Denmark , paragraph 44; Commission  v France , paragraph 51; and Commission v Austria , paragraph 87).
88. 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 or to meet overriding requirements such as, for example the protection of consumers; 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 Commission  v Denmark , paragraph 45; Commission  v France , paragraph 52; Commission  v Austria , paragraph 88; and Commission  v Germany , paragraph 87).
89. 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 to public health ( Commission v Denmark , paragraph 46; Commission  v France , paragraph 53; Commission  v Austria , paragraph 89; and Commission  v Germany , paragraph 88).
91. In the present case, while, as was stated in paragraph 87 of this judgement, Community law does not, in principle, preclude a system of prior authorisation, it remains however clear that the issuing of marketing authorisation pursuant to Article 8 of Directive 2001/83 is subject to particularly strict requirements ( Commission  v Germany , paragraph 89). In that regard, it must be observed that the Kingdom of Spain has not contended that all or some of the products withdrawn from the market in 2002 and 2003 could take advantage of a simplified registration procedure such as that established by Articles 16a to 16i of that directive for traditional herbal medicinal products.
92. In those circumstances, the obligation to obtain marketing authorisation before being able to market products based on medicinal herbs on Spanish territory may be regarded as in accordance with the principle of proportionality only if it is actually necessary, in each case, to safeguard public health (see, to that effect, Commission  v Austria , paragraph 94, and Commission  v Germany , paragraph 90).
93. Such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment, on a case‑by‑case basis, of the risk alleged by the Member State invoking Article 30 EC (see, to that effect, Commission  v Austria , paragraph 96, and Commission  v Germany , paragraph 91).
97. Moreover, as regards effective consumer protection, to which the Kingdom of Spain also refers, it is naturally legitimate to seek to ensure that consumers are properly informed about the products which they consume ( Commission  v France , cited above, paragraph 74).
98. However, the Kingdom of Spain has not explained why appropriate labelling, informing consumers of the nature, the ingredients and the characteristics of products based on medicinal herbs, would not adequately meet that objective where the classification of those products as medicinal products is not justified on grounds of public health (see, by analogy, Commission  v France , paragraph 75).
106. Decision No 3052/95 defines ‘measure’ as any measure taken by a Member State, except for judicial decisions, which has the effect of restricting the free movement of goods lawfully produced or marketed in another Member State, regardless of its form or the authority from which it emanates (Joined Cases C‑388/00 and C‑429/00 Radiosistemi  [2002] ECR I‑5845, paragraph 68, and Case C‑432/03 Commission  v Portugal  [2005] ECR I‑9665, paragraph 57).