C-405/95

II — Facts The national court states that the therapeutic information notices supplied by the com­ pany manufacturing the product describe the drops in question as being 'Traditionally used as a prophylactic: taken preventively, 2. On 31 May 1994 the Oberfinanzdirektion Echinacea Drops provide protection at times München (Principal Revenue Office, of increased risk of infection from colds and Munich, Germany) issued the applicant Bio- enhance resistance to feverish colds'. The force GmbH with a binding notice of cus­ recommended dose as a prophylactic is 20 toms tariff classification in which it stated drops taken in a little water three times a that the product in question, consisting of day. Echinaforce packages also recommend a Echinacea extract-based drops, must be clas­ dose of 20 drops three times a day for pre­ sified under subheading 2208 90 69 of the ventive purposes and, in cases of severe Combined Nomenclature, 'other spirituous colds, 20 to 30 drops five times a day. The beverages'. The applicant contested that instructions for use go on to list contraindi­ notice in an action before the Finanzgericht cations. München (Financial Court, Munich).

3. The substance whose tariff classification is in issue consists of a mixture of vegetable

4. The national court states further that, * Original language: Italian. according to the notice issued by the

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OPINION OF MR LA PERGOLA — CASE C-405/95

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BIOFORCE vOBERFINANZDIREKTION MÜNCHEN

Heading 2208 concerns the following prod­ that chapter does not cover 'foods or bever­ ucts: ages such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters'.

'Undenatured ethyl alcohol of an alcoholic strength by volume of less than 80% vol.: spirits, liqueurs and other spirituous bever­ ages; (...)'· IV — Analysis of the dispute

Subheading 2208 90 69 covers 'other spiritu­ ous beverages'. 9. In essence, the dispute which the Court is asked to resolve concerns the definition of 'medicament' to be used for the purpose of deciding whether or not the products in question should be included in tariff heading Note 1 (e) of the introductory notes to Chap­ 3004. The Court has already been called ter 22 of the CCT expressly states that that upon to give a ruling on a similar question in chapter does not cover 'medicaments of which the issue was the customs classifica­ heading No 3003 or 3004'. 3 tion of hawthorn drops. It should also be borne in mind that the term medicament is used in Community legislation 4 and has been the subject of several judgments deliv­ ered by this Court, of which Case C-219/91 8. Chapter 30 of the Common Customs Tar­ 5 Ter Voort is of particular relevance to the iff concerns 'Pharmaceutical products'. present case. Those judgments define the framework within which the problem now submitted for the Court's consideration must be considered and resolved. Heading 3004 covers:

'Medicaments (...) consisting of mixed or 10. Let me now turn to the first question, unmixed products for therapeutic or pro­ which is whether the product concerned is a phylactic uses, put up in measured doses or in forms or packings for retail sale'.

medicament. What meaning should we give 'hawthorn drops' judgment. The Court spe­ to the concept of 'Medicaments (...) consist­ cifically ruled that it is necessary to consider ing of mixed or unmixed products for thera­ the actual nature of the product, that is to peutic or prophylactic uses, put up in mea­ say that the characteristics and properties of sured doses or in forms or packings for retail the product must be objectively appraised. It sale' used in heading 3004 of the Common should be added that, in the light of Ter Customs Tariff? In its observations the Voort, it is also necessary to establish how Commission states that in the circumstances the product is regarded by averagely well- of this case classification as a medicament is informed consumers in order to decide precluded by the explanatory notes to Chap­ whether or not it is covered by the tariff ter 30 of the Common Customs Tariff. The heading in question. The fact that the official rule is that 'The description of a product as a pharmacopoeia of a Member State counts a medicament in Community legislation (other particular product as a medicament may than that relating specifically to classification therefore constitute one criterion of assess­ in the combined nomenclature) or in the ment, but is not the only valid evidence for national legislation of the Member States, or that purpose. Similarly, the fact that the in any pharmacopoeia, is not the deciding product is not among those listed in the factor in so far as its classification in (...) pharmacopoeia does not, to my mind, prove [C]hapter [30] is concerned'. However, the conclusively that it is not a genuine medica­ Commission interprets that rule in one way ment. only: it considers that the fact that a product is classified as a medicament for other pur­ poses does not mean or necessarily imply that it is covered by the heading concerning medicaments in the Common Customs Tariff. 12. Furthermore, Community legislation very clearly draws the distinction which I have pointed out. According to Article 1(2) of Directive 65/65/EEC, cited above, a medicinal product is 'any substance or com­ bination of substances presented for treating or preventing disease in human beings or 11. I, however, am not persuaded by that animals. Any substance or combination of reading of the provision. Were it to be substances which may be administered to adopted, the result would be the introduc­ human beings or animals with a view to tion of further classification criteria other making a medical diagnosis or to restoring, than those required by the facts and by the correcting or modifying physiological func­ Community legislation, in order to be able tions in human beings or animals is likewise to determine whether or not a particular to be considered a medicinal product'. product falls into the category of medica­ ments for the purposes of the Common Cus­ toms Tariff. I take the view that the first mentioned rule of interpretation means something else, much simpler and more logi­ cal. The provision merely sets out a criterion for interpretation which the Court has, Thus Community legislation provides a defi­ moreover, had occasion to define in the nition of medicinal product 'by virtue of

presentation'. It should be noted that Advo­ therapeutic substance, that is to say, a cate General Tesauro, in his Opinion in medicinal product'. Ter Voort, cited above, stated that 'the defini­ tion of a medicinal product "by virtue of presentation" also covers products indicated or recommended as having therapeutic or prophylactic properties by oral representa­ tion and, more generally, all products which appear to the averagely well-informed con­ 13. In the light of the foregoing, I am sumer in the light of their presentation to be inclined to consider that there are various 6 medicinal products'. Mr Tesauro went on, factors which come into play in determining in the same Opinion, to assert that 'even a whether or not a product is a medicament product which is generally regarded as a for the purposes of heading 3004: in addition foodstuff and, in the present state of scien­ to the official classification in the pharmaco­ tific knowledge, has no pharmacological poeia, the product's particular properties as properties whatsoever, falls within the Com­ indicated on the packaging, the manner in munity definition of a medicinal product by which it is presented for sale, its recom­ virtue of its presentation within the meaning mended use, the method of administration, of the first paragraph of Article 1(2) of the place in which it is marketed, and also Directive 65/65 where it is presented by the the general perception of the substance as seller or a third party linked to the seller as being a medicinal product, constitute useful having therapeutic or prophylactic proper­ criteria and relevant evidence for the purpose ties'. The Court fully endorsed the Advocate of determining its classification in one head­ General's point of view, declaring that: 'even ing or another of the Common Customs if it comes within the scope of other, less Tariff. stringent Community rules, such as the rules on cosmetic products, a product must be held to be a medicinal product and be made subject to the corresponding rules if it is pre­ sented as possessing therapeutic or prophy­ lactic properties or if it is intended to be administered with a view to restoring, cor­ In any event, it would be impossible to con­ recting or modifying physiological functions. sider a different interpretation which would Moreover, the fact that a product is in the imply that the Community legislature nature of a foodstuff cannot prevent it from intended to lay down contradictory rules: being categorized as a "medicinal product" such a conclusion could only create confu­ within the meaning of the provisions of the sion for those called upon to apply the law first subparagraph of Article 1(2) of Direc­ and lead to a situation of legal uncertainty as tive 65/65 in so far as the indication or rec­ to the true definition of a medicament. That ommendation of its therapeutic or prophy­ definition cannot vary according to whether it is a question of applying the rules govern­ lactic properties is in itself of such a kind as ing the pharmacological sector or of placing to cause it to be regarded as a product pre­ the product in the appropriate heading of the senting the characteristic properties of a Common Customs Tariff.

14. Furthermore, the Commission's obser­ by the Court in its judgment in Colin and vation that the product in question is not Dupré. used for the treatment or prevention of a specific illness in a particular part or area of the body, but rather performs a generic pro­ phylactic function is not pertinent. If the condition which the Commission considers necessary were really fundamental and nec­ essary in order for a preparation to be classed as a medicament, a whole series of substances which are undeniably medica­ 16. The other observations submitted by the ments and which have a definite broad- Commission in order to show that heading spectrum prophylactic and/or preventive 3004 of Common Customs Tariff cannot function, such as antibiotics or immunizing cover products such as those involved in this substances, or which, like aspirin, have vari­ case are not, in my view, well founded. The ous functions, could not be classified in distinction which the Commission seeks to heading 3004. draw between medicaments and tonic bever­ ages under heading 2208 does not seem to me to be relevant: the action on the human body of the food supplements to which the Commission refers cannot be regarded as the transformation or alteration of a physiologi­ cal function. On the other hand, Echinacea Drops cause a real increase in phagocytosis: the Commission, nevertheless, disputes the view that the change brought about by tak­ 15. In the case with which we are concerned, ing the product concerned is sufficient to without prejudice to the more detailed enable it to be classified as a medicament. assessment of the facts which naturally falls The Commission, however, confuses supple­ to the national court, it is certain, for menting substances in which the body is example, that the presentation of the product deficient (vitamins and minerals) with the and its recommended administration make it actual alteration of a normal physiological impossible to contemplate its use for other process. Nor is it relevant in this respect than medicinal purposes. It does not display that, as the Commission is anxious to point any particular organoleptic properties mak­ out, there are substances which, while ing it suitable for different usage, thus trans­ capable of effecting a change in the body, are forming it into a drink for consumption in none the less classified as food supplements: moments of relaxation or at other times. To the difference in those cases is that those my mind, its unambiguous usage, together substances do not have the primarily thera­ with the other criteria already considered, peutic or prophylactic purpose of fighting or constitutes decisive evidence for the pur­ preventing disease. The cases cited by the poses of the possible classification of the Commission concern substances which do product in question as a medicament under not in themselves contain active ingredients the Common Customs Tariff, irrespective of intended to cure or prevent disease (for its actual pharmacological nature and the proven presence of active principles with an efficacious therapeutic or prophylactic 8 — Joined Cases C-106/94 and C-139/94 Colin and Dupré action. This argument inter alia was upheld [1995] ECR I-4759, paragraph 28.

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