C-328/97

OPINION OF MR FENNELLY — CASE C-328/97

OPINION OF ADVOCATE GENERAL FENNELLY delivered on 1 October 1998 *

Introduction on the Harmonised Commodity Description and Coding System (hereinafter 'the HS') of 2 the Customs Cooperation Council.

1. The present case concerns the tariff clas­ sification of two types of tablets, containing high concentrations of Vitamin C (ascorbic acid) and some calcium, as medicaments (head­ ing No 3004), as food preparations (heading No 2106) or as provitamins and vitamins (heading No 2936). 3. Within Chapter 30, 'Pharmaceutical prod­ ucts', of the CN , heading No 3004 refers to 'Medicaments (excluding goods of heading No 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or pro­ Legal and factual background phylactic uses put up in measured doses or in forms or packings for retail sale'. Subheading No 3004 50 refers to Other medicaments con­ taining vitamins or other products of heading No 2936'; its subdivision No 10 concerns such products 'Put up in forms or in packings of a kind sold by retail'. According to Note 1(a) in the introduction to Chapter 30 of the CN , that chapter does not cover 'foods or bever­ 2. The present case concerns the Communi­ ages (such as dietetic, diabetic or fortified ty's Combined Nomenclature (hereinafter 'the foods, food supplements, tonic beverages and CN' ), in the version established by Commis­ mineral waters)', which fall to be classified in sion Regulation (EEC) No 2505/92 of 14 July 3 Section IV of the CN . 1992 amending Annexes I and II to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff. 1The CN is based 2 — Since 1994, the Customs Cooperation Council is unofficially known as the World Customs Organisation. 3 — Such chapter notes form part of the combined nomenclature; see Article 1(2)(c) of Council Regulation (EEC) No 2658/87 * Original language: English. of 23 July 1987 on the tariff and statistical nomenclature and 1 — OJ 1992 L 267, p. 1. on the Common Customs Tariff, OJ 1987 L 256, p. 1.

'The description of a product as a medica­ ment in Community legislation (other than that relating specifically to classification in the combined nomenclature) or in the national legislation of the Member States, or in any The HSENs also include text very similar to pharmacopoeia is not the deciding factor in the above-quoted CN Note 1(a) and explain so far as its classification in this chapter is that the exclusion of foodstuffs and beverages concerned.' applies 'essentially ... as regards food prepara­ tions containing only nutritional substances. The major nutritional substances in food are 5 — The CNENs arc adopted by the Commission pursuant to Article 9(1)(a) of Regulation No 2658/87, loc. cit. They arc stated to be complementary to the HSENs, to which they make frequent reference. For a consolidated version of the 4 — See, most recently, World Customs Organisation, Harmon- CNENs, see OJ 1994 C 342, p. 1. The most recent version ised Commodity Description and Coding System: Explanatory was published after the hearing in this case, OJ 1998 L 287, Notes, 2nd. cd. (Brussels, 1996). p. 1.

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OPINION OF MR FENNELLY — CASE C-328/97

6. Within Section IV of the CN , Chapter 21 to the terms of the headings in the CN and is entitled 'Miscellaneous edible preparations'. any relative section or chapter notes. As Heading No 2106 concerns 'Food prepara­ such, the chapter notes are a useful aid to the 7 tions not elsewhere specified or included'. interpretation of the CN . The CNENs and According to Note 1(g) to Chapter 21 of the HSENs may be an important aid to the inter­ CN , that chapter does not cover 'yeast put pretation of the scope of the various tariff up as a medicament or other products of headings but do not have legally binding 8 heading No 3003 or 3004'. The HSENs state force. that the identically worded heading of the HS includes, inter alia:

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GLOB-SPED v HAUPTZOLLAMT LÖRRACH

Each tablet weighing 750 mg contains: 11. Reference should also be made to Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action 12 relating to proprietary medicinal products, which provides that no proprietary medicinal — Ascorbic acid: 500 [m]g products may be placed on the market in a Member State unless an authorisation has been issued by the competent authority of 13 that Member State. The objective of the Directive is to remove hindrances to intra- Community trade in proprietary medicinal — Rose hip powder, cellulose, vegetable products arising from disparities between stearine, botanical oil solids, magnesium national provisions while respecting the pri­ stearate, silicon dioxide and food glaze 14 mary goal of safeguarding public health. containing protein: 250 mg'. Article 1(2) of Directive 65/65/EEC defines a medicinal product as follows:

These tablets are classified under heading No 2106 90 91.

'Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

10. Commission Regulation (EEC) No 2723/90 of 24 September 1990 replacing the codes established on the basis of the Common Customs Tariff nomenclature in force on 31 December 1987 with those estab­ lished on the basis of the Combined Nomen­ clature in certain Regulations concerning the classification of goods 10 classifies multivi­ Any substance or combination of substances tamin pills and effervescent multivitamin pills which may be administered to human beings containing, inter alia, 60 mg and 75 mg of or animals with a view to making a medical Vitamin C respectively under CN heading diagnosis or to restoring, correcting or modi­ No 2106 90 99 for the purposes of Commis­ fying physiological functions in human beings sion Regulation (EEC) No 210/85 of 25 Janu­ or in animals is likewise considered a medicinal ary 1985 classifying goods in subheading 21.07 product.' 1 G I d) 1 of the Common Customs Tariff. 1

'Whatever the actual therapeutic or prophy­ lactic value of the products in question, it 13. Bioforce v Oberfinanzdirektion 19 must be held that the description of the cura­ München (hereinafter 'Bioforce II') con­ tive or prophylactic properties of those prod­ cerned the tariff classification of products ucts as well as the way in which they are consisting of a fresh herbal tincture of packaged, dispensed and marketed is in itself Echinacea purpurea which were offered for such as to cause them to be regarded as prod­ sale in packages mentioning their composi­ ucts possessing the characteristic properties tion, spheres of application and recommended of a medicament and, by correlation, to exclude the possibility that they might be used for purposes other than those of a therapeutic or 21 15 — Case C-177/91 Bioforce [1993] ECR I-45. prophylactic nature.' 16 — Ibid., paragraphs 8 and 9. The Court cited Case C-338/90 Hamlin Electronics v Hauptzollamt Darmstadt [1992] ECR I-2333, paragraph 8. 17 — Opinion of Advocate General Gulmann, paragraph 5. 18 — Loc. cit., paragraph 12. 20 — Ibid., paragraph 14. 19 — Case C-405/95 [1997] ECR I-2581. 21 — Ibid., paragraph 15.

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GLOB-SPED v HAUPTZOLLAMT LÖRRACH

23 14. In LTM, the Court was asked about the tariff classification of two products, one of which contained certain vitamins in amounts several times higher than the levels 15. Glob-Sped AG (hereinafter 'the appli­ of the Reference Intake for a Population and cant') requested the Hauptzollamt Lörrach which was stated to be recommended for the (Principal Customs Office, Lörrach, herein­ prevention or correction of vitamin deficien­ after 'the defendant') on 26 January 1993 to cies linked to an inadequate or unbalanced admit the two products in question in the diet, the other of which was a combination of present case into free circulation as medica­ amino acids, mineral salts and trace elements ments. The two products are Taxofit Vita­ and was stated to be recommended in cases of min C + Ca Brausetabletten, soluble tablets debility, convalescence, overwork, poor appe­ containing 1 000 mg of Vitamin C, and Tax­ tite, weight loss and ageing. The Court found ofit Vitamin C Kautabletten, chewable tablets that neither product had clearly defined thera­ containing 500 mg of Vitamin C. These quan­ peutic or prophylactic characteristics with an tities appear to be greatly in excess of that effect concentrated on precise functions of recommended for normal dietary purposes the human organism and that neither was 29 (on average 75 mg per day). The packaging capable of being applied in the prevention or of both products states that they are to be treatment of diseases or ailments, as required 24 taken to reinforce the immune system in cases by the judgment in Bioforce I. The fact that of heightened risks of infectious illnesses, the products in question were the subject of such as colds or flu, or in cases of overwork, an authorisation to be marketed in France as 2 medicinal products, 5 that they were pre­ sented as medicinal products and that they were distributed exclusively in pharmacies 26 — LTM, loc. cit., paragraphs 38 and 46. 27 — Ibid., paragraph 24. Sec also the Opinion of Advocate Gen­ eral Elmer, paragraph 16, and his Opinion in Colin and Duprė, loc. cit., paragraphs 15 and 16; the Opinion of Advo­ cate General Gulmann in Bioforce ƒ, loc. cit., paragraph 7; Van Bennekom, loc. cit.; and the CNENs to Chapter 30 of 22 — Ibid., paragraph 16. the CN. Cf. the Opinion of Advocate General La Pergola 23 — Loc. cit. in Bioforce II, loc. cit., paragraphs 12 and 13. 24 — Paragraphs 37 and 45 of the judgment in LTMT Ioc. cit. See 28 — Ibid., paragraph 25; see the eighth recital in the preamble to Bioforce I, loc. cit., paragraph 12. Regulation No 2658/87. 25 — See paragraph 26. 29 — See paragraph 16 below.

16. The defendant took the view, following an expert study, that the products should be classified as 'other food preparations not else­ where specified or included' (heading No 2106 90 99 of the CN). The Finanzgericht 17. The national court took the view that a (Finance Court) rejected the case claim of the product is not a medicament if it merely applicant, on the grounds that there was no combats a deficiency, even if it thus indirectly indication on the pack of the tablets' specific counteracts deficiency diseases. The product 30 must act both as a replacement in case of effectiveness against defined illnesses and that the products in question should, there­ deficiency and as a treatment or prophylactic fore, be classified as vitamins. The applicant for non-deficiency diseases. It suggested that appealed to the Bundesfinanzhof (Federal Bioforce II attached greater importance than Finance Court, hereinafter 'the national previous cases to the presentation of prod­ court'), seeking the quashing (Revision) of the ucts, with the result that the tablets in ques­ decision of the Finanzgericht. The applicant tion could probably be deemed to be medi-

30 — The Finanzgericht relied upon Bioforce I and Colin and 31 — Loc. cit. Dupré, loc. cit. 32 — Bundesanzeiger No 97, 2 May 1991.

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GLOB-SPED v HAUPTZOLLAMT LÖRRACH

2. If Question 1 is answered in the negative: 19. The applicant states that the Finanzger­ icht accepted that the products in question have prophylactic and therapeutic functions, so that there is no need to answer the first question. Provided specific instructions are given for the use of the products for medicinal purposes, the fact that the product is also Is the Combined Nomenclature for 1993 to stated to have other, merely fortifying quali­ be interpreted as meaning that vitamin pills ties cannot alter its CN classification as a

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OPINION OF MR FENNELLY — CASE C-328/97

medicament. The subjective intention with tion. In the wake of the judgment in Biofor- which a product is marketed can affect its ce II, the Commission would not recommend objective characteristics, through the choice reliance on Regulation No 2061/89 to deter­ of packaging and of the language used thereon. mine, by analogy, the classification of prod­ 33 Thus, if the Court decides to answer the first ucts outside its immediate scope. question, the applicant submits, in reliance on the judgment in Bioforce II, that it should be answered in the affirmative, resulting in paral­ lelism between the CN classification and the scope of Directive 65/65/EEC, which is prin­ cipally based on the presentation of products.

21. France submits that the manner in which a product is presented and the grant of a mar­ keting authorisation are merely complemen­ tary indices for customs classification pur­ poses; the product's objective characteristics remain central. On the facts of the case, both the product's objective characteristics and its presentation point towards its classification as a medicament.

23. The decisive criterion based on 'objective heading No 3004 of the CN 'a whole series of characteristics' is the basis of the reasoning in substances which are undeniably medicaments all the cases. In the case of medicaments, and which have a definite broad-spectrum this entails interpretation in the light of 'medi­ prophylactic and/or preventive function, such cal developments', or, as stated in Bioforce I, as antibiotics or immunising substances, or 38 that the product have 'clearly defined thera­ which, like aspirin, have various functions'. peutic [or] prophylactic characteristics, the effect of which is concentrated on precise 35 functions of the human organism'. This requirement should not be construed too strictly. Thus, in Bioforce I, the Court deemed it to be satisfied by drops which eased minor cardiac difficulties caused by ageing, contrary to the suggestion of Advocate General Gul- mann, who took the view that the drops were not designed for a specific illness and that 36 their effect was not sufficiently specific. In Bioforce II, the Court characterised as medi­ caments products designed to strengthen the body's resistance to colds and other infec­ 24. On the other hand, products containing tions, to promote recovery after infection and substances with potential prophylactic or ther­ to treat certain skin conditions. The Court's apeutic functions will not merit customs clas­ reference in Bioforce I to 'precise functions of sification as medicaments if those substances the human organism' 37 is, in my view, to be are present in insufficient quantities to have understood as referring to identifiable func­ such effects. This was the case in Colin and tions of the body; this is the application to Dupré, where the substances in question, the facts of that case of its view that the present in throat pastilles, acted merely as fla­ 39 heading was to be interpreted in the light of vouring agents; and in LTM, the multivi­ 'medical developments'. This is also consis­ tamin tablets under consideration could not tent with the approach taken on this point by be used to combat specific deficiencies of a Advocate General La Pergola in Bioforce II. particular vitamin without risk of overdose of In response to the Commission's argument other vitamins, so that they were of use only that the products at issue merely performed as a daily dietary supplement intended to a generic prophylactic function, and should maintain general health and well-being. The not be classed as medicaments, he observed other product at issue in that case, which that such a condition would exclude from combined amino acids, mineral salts and trace elements, had extremely general effects in

27. It should be noted that the packaging of 25. In my view, the high-dosage Vita­ the products in question does not refer to the min C tablets which are the subject of the two illnesses mentioned above. It concen­ present case have clearly defined therapeutic trates instead on the products' more general and prophylactic characteristics. First of all, effects on the body's immune system. It also the dosage of Vitamin C is far higher than is refers to their traditional use as a strength- needed or recommended for normal daily ener, which use, taken on its own, would not intake as a dietary supplement. More impor­ be sufficient to qualify the products as a tantly, in addition to assisting the body's medicament, in my view, regard being had to immune system to resist infection at times of the judgment in LTM. At the same time, it is debility, overwork and so on, such high con­ clearly stated that the products are medica­ centrations of Vitamin C are also recom­ ments, to be handled with care and in accor­ mended in response to allergic reactions and dance with the posology and instructions severe traumas, such as may arise from an given. It might be concluded from this that injury or surgical operation, as well as to at the manufacturer wished simultaneously to least two specific (if rare) illnesses, scurvy and enhance the potential market for these prod­ Moeller-Barlow disease. ucts among persons generally interested in their own health and to present them, as is justified by their objective characteristics, as medicaments suitable for treatment of par­ ticular conditions or ailments. The presenta­ tion of the products can thus be concluded to be ambiguous.

ments in the light of their objective prophy­ keting aspects of products, whatever their lactic or therapeutic qualities. effect on the perception of a product by con­ sumers, are merely complementary to that decisive criterion. Thus, the Court referred to authorisation to market a product as a medi­ cament as evidence of its objective character­ 44 istics and properties, thereby confirming the centrality of that criterion. Similarly, state­ 29. This leads me to make a few closing ments in the packaging or instructions of a remarks concerning the first question. The product can also constitute complementary national court refers in particular to the state­ evidence that it possesses any objective pro­ ment in paragraph 15 of the judgment in Bio- phylactic or therapeutic properties claimed, force II that the description, packaging and on the assumption that such statements are manner of marketing the drops at issue in correct. that case could cause them to be regarded as medicinal products, '[w]hatever the actual therapeutic or prophylactic value of the prod­ 41 ucts in question'. It infers from this state­ ment the possibility that the presentation of products could in itself, without regard to their objective characteristics, permit them to be classified as medicaments. This was also suggested by Advocate General La Pergola, who argued for the concept of a medicinal product to be similarly defined for the pur­ poses of customs classification and of Direc­ tive 65/65/EEC by reference to the criteria 42 set out in that Directive. 31. This conclusion is not contradicted, in my view, by the HSENs concerning heading 45 No 3004 of the HS. Those explanatory notes merely serve to distinguish medicinal prod­ ucts put up in measured doses or in forms or packings for retail sale from those not so put 30. However, I do not think such an infer­ up, which fall under heading No 3003, and ence is justified. The Court's statement in do not affect the dividing line between medic­ paragraphs of its judgment in Bioforce II inal and other products, such as food prepa­ must be read in the light of its earlier refer­ rations. This is most clearly demonstrated by ence to the product's objective characteristics the reference to sale directly to users without and properties as the decisive criterion for repacking and by the last sentence of the 43 customs classification. There is nothing in HSENs quoted above. Bioforce II to detract from the Court's con­ sistent statement that presentational and mar­

Products such as those described in the order for reference are to be classified under heading No 3004 50 10 of the Combined Nomenclature , in the version established by Commission Regulation ( EEC ) No 2505/92 of 14 July 1992 amending Annexes I and II to Council Regulation ( EEC ) No 2658/87 on the tariff and statistical nomen­ clature and on the Common Customs Tariff.

46 — Loc. cit., paragraphs 24 to 27. See my summary at para­ graph 14 above.

47 — Quoted in paragraph 5 above.

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