Laboratoires de thérapeutique moderne (LTM) v Fonds d'intervention et de régularisation du marché du sucre (FIRS).
Date: 1997-11-06
17 It is settled case-law that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods for customs purposes is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the CN (see, with regard to the CCT, Case C-459/93 Hauptzollamt Hamburg-St Annen v Thyssen Haniel Logistic [1995] ECR I-1381, paragraph 8, and Joined Cases C-106/94 and C-139/94 Colin and Dupré [1995] ECR I-4759, paragraph 22).  There are also explanatory notes drawn up, as regards the CN, by the European Commission and, as regards the Harmonized Commodity Description and Coding System, by the Customs Cooperation Council, which may be an important aid to the interpretation of the scope of the various tariff headings but do not have legally binding force (Case C-35/93 Develop Dr Eisbein v Hauptzollamt Stuttgart-West [1994] ECR I-2655, paragraph 21, and Colin and Dupré, cited above, paragraph 21).
24 The concept of a pharmaceutical product in the CN is distinct from that of a medicinal product appearing in Directive 65/65.  The latter directive is designed to eliminate - at least in part - obstacles to trade in proprietary medicinal products within the Community whilst at the same time attaining the essential objective of safeguarding public health (Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 14).  Thus, with a view to promoting trade and at the same time protecting public health, the directive allows a relatively large spectrum of products to be covered by the control system laid down in the legislation on medicinal products.  It should also be noted that, in Case C-369/88 Delattre [1991] ECR I-1487, paragraphs 27 and 29, the Court held that, with regard to Directive 65/65, the fact 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 concerned when it displays the characteristics of such a product.  The Court also recognized in that case that, so long as harmonization of the measures necessary to ensure the protection of health is not more complete, differences in the classification of products as between Member States will continue to exist in the context of the directive.
27 The same holds true for the argument relied on by LTM to the effect that Alvityl and Strongenol are medicinal products by virtue of their presentation and are distributed solely in pharmacies.  Although, according to the Court's case-law, such factors are strong indications that the products in question are to be treated as medicinal products within the meaning of Directive 65/65, the decisive criterion for the tariff classification of goods according to the CN must in general be sought, as pointed out in paragraph 17 of this judgment, in their objective characteristics and properties as defined in the wording of the CN heading.
29 Moreover, in Case C-177/91 Bioforce v Oberfinanzdirektion München [1993] ECR I-45, paragraph 12, the Court ruled that a pharmaceutical product within the meaning of heading 30 04 of the CN has clearly defined therapeutic and, above all, prophylactic characteristics, the effect of which is concentrated on precise functions of the human organism.
37 Furthermore, it has not been established either that Alvityl has clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the human organism or that it is capable of being applied in the prevention or treatment of diseases or ailments.
45 Although LTM states that a serious insufficiency of iodine intake in a foetus may lead to death at the time of birth, it has not been demonstrated that Strongenol is capable of being applied in the prevention or treatment of such a medical condition or in the prevention or treatment of any other disease or ailment.  More generally, it has not been shown that Strongenol has a clearly defined therapeutic and, above all, prophylactic effect on precise functions of the human organism, as required by the abovementioned judgment in Bioforce.
48 It should also be borne in mind that, in paragraph 11 of the judgment in Thyssen Haniel Logistic, cited above, the Court held that amino acids, as basic constituents of proteins, may be regarded as nutritional substances.  While the Customs Cooperation Council's Explanatory Notes to heading 30 04 state that the provisions of the heading text do not apply to foodstuffs or beverages, which fall to be classified under their own appropriate headings, they point out that proteins feature among the major nutritional substances in food.  Moreover, food products are classified under Chapter 21 of the CN.