C-201/96

Heading N o 21.06 covers 'food preparations not elsewhere specified or included'.

2. Chapter 21 of the Customs Tariff covers 'miscellaneous edible preparations'.

* Original language: Danish. 1 — Council Reguládon (EEC) N o 2658/87 of 23 July 1987 on 3. Chapter 30 of the Customs Tariff covers the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1987 L 256, p. 1). 'pharmaceutical products'.

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N o t e 1(a) in the introduction to Chapter 30 proteins, carbohydrates and fats. Vitamins reads as follows: and mineral salts also play a part in nutrition.

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the body in good health and should be — biotin 100 meg regarded as food preparations [fifth recital in — iron 10 mg the preamble]. — zinc 7.5 mg — manganese 2 mg — copper 1 mg — molybdenum 150 meg — iodine 75 meg — selenium 50 meg

Article 1 — chromium 50 meg — sucrose (including invert sugar expressed as sucrose) 33% — water approximately 7% The following products for sale by retail:

(a) pills having the following composition (per pill):

shall be classified in the Common Customs Tariff under subheading N o 2106 90 99 ...'. — vitamin A 2 000 IU — vitamin C 60 mg — vitamin D 200 IU — vitamin E 12 IU 5. Council Regulation (EEC) N o 1010/86 of 25 March 1986 laying down general rules for — vitamin Bl 1.1 mg the production refund on certain sugar prod- — vitamin B2 1.2 mg ucts used in the chemical industry, 4 as amended by Article 9 of Commission Regu- — vitamin B6 2 mg lation (EEC) N o 1714/88 of 13 June 1988 5 — niacinamide 13 mg ('Regulation N o 1010/86'), lays down rules relating to the grant of refunds to undertak- — calcium pentothenate 4.3 mg ings using sugar for the production of certain — vitamin B12 3 meg chemical products, including products covered by Chapter 30 of the Common — folic acid 50 meg 3

The content of vitamins A and D3 was sub- sequently reduced and is at present 1 500 IU 7. However, the Fonds d'Intervention et de and 150 IU respectively. Régularisation du Marché du Sucre, which administers the aid scheme in France, refused to recognize them as pharmaceutical prod- ucts within the meaning of Chapter 30 of the Common Customs Tariff and classified them instead as products covered by Chapter 21 ('miscellaneous edible preparations'). It demanded repayment of the refunds paid Alvityl was accompanied by the following and also claimed penalties. LTM instituted information: 'this preparation is recom- proceedings against these claims before the mended for the prevention or correction of Tribunal Administratif (Administrative vitamin deficiencies due to an inadequate or Court), Paris. unbalanced diet'.

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In the course of the proceedings LTM ALVITYL is used in non-deficiency subjects referred to an expert report of 17 August in the symptomatic treatment of general 1990 by Dr Annie Rousseau, of LTM's clini- debility. cal research and development department. This report concluded as follows:

NB: This product is not suitable for the treatment of a specific vitamin deficiency.' 'ALVITYL is indicated in certain deficiency conditions:

— restrictive or unbalanced diet regimes (low-calorie diets, strict vegetarian diets, 9. At the material time, one 10 ml ampoule etc.) of Strongenol 20 had the following composi- tion:

Strongenol was accompanied by the follow- active substances and have a therapeutic pur- ing information concerning use: pose and, in any case, they have an appre- ciable effect on the body. They are pharma- ceutical products with preventive and curative properties, taken in order to restore, correct or modify organic functions and they can be purchased only from pharmacists. 'General debility or a reduction in physical Alvityl contains 50 to 150% of the recom- or mental efficiency, convalescence, over- mended daily intake of most vitamins, serves work, poor appetite, loss of weight, ageing'. to prevent or treat multi-vitamin deficiencies and is usually bought by patients on a doc- tor's prescription. Strongenol contains min- eral salts, including iodine, and serves to treat all kinds of debility. Because of its iodine content, it may be taken only on a 10. The Tribunal Administratif, Paris, stayed doctor's prescription. the proceedings and referred to the Court a question in the following terms:

Strongenol 20 was prescribed to overcome General observations iodine deficiency. Its iodine content indicates the product's therapeutic and prophylactic properties. Serious health problems may arise from both a deficiency and an excess of iodine. Strongenol 20 must be regarded as a pharmaceutical product by virtue of its iodine content. 14. It should be noted that Regulation N o 1010/86 authorizes production refunds o n sugar used for the products listed in the annex to the regulation. The annex refers t o Chapter 30, 'Pharmaceutical products', of the Common Customs Tariff, but not Chap­ ter 21, 'Miscellaneous edible preparations'. Therefore if products are in law covered b y Chapter 21, they do not fall within the ambit of the regulation. Only if products are cov­ ered by Chapter 30 will they fall within the 13. The Commission contends that as the ambit of the regulation and it is only on this body requires a sufficient daily intake of hypothesis that there will be a legal basis for vitamins, multi-vitamin tablets such as Alvi- granting the production refund. Conse­ tyl should be regarded as a necessary part of quently the issue in the case before the the diet rather than as a pharmaceutical national court is whether the products are product. This is confirmed by the explana­ covered by Chapter 30 of the Common Cus­ tory leaflet for Alvityl. The regular taking of toms Tariff and the question referred must products such as Alvityl has become a very therefore be construed as requesting inter­ widespread habit and they are consumed in pretation of that chapter. order to maintain good health.

of the Customs Cooperation Council are in part — obstacles to trade in proprietary important means for ensuring the uniform medicinal products within the Community application of the Tariff throughout the whilst at the same time attaining the essential Community and as such may be regarded as objective of safeguarding public health. 9 useful aids to its interpretation: see the judg- Directive 65/65 thus permits a relatively ments in Case C-459/93 6 and Joined Cases wide range of products to come within the C-106/94 and C-139/94. 7 system of controls laid down by the legisla- tion on pharmaceutical products in order to encourage trade and at the same time to pro- tect public health. In view of the objective of consumer protection, therefore, the Court has broadly construed the first definition of the term 'medicinal product', taking the pre- sentation of the product as its starting 16. With regard to the Customs Tariff, it is point. 1 0 not necessary to examine the considerations on the basis of which a given product is clas- sified as a pharmaceutical product under Community legislation or that of the Mem- ber States relating to pharmaceutical prod- ucts. This is also clear from the general observations on Chapter 30 contained in the explanatory notes to the Common Customs Tariff, which state that 'The description of a product as a medicament in Community leg- The fact that Alvityl and Strongenol have islation ... or in the national legislation of the been marketed with the authorization of the Member States, or in any pharmacopoeia, is French authorities and are therefore deemed not the deciding factor in so far as its classi- by French law to be pharmaceutical products fication in this chapter is concerned'. does not ipso facto mean that they must also be classified as pharmaceutical products under the Common Customs Tariff.

'It is, however, apparent from the file and from the observations submitted to the Court, taken as a whole, that it is impossible 19. With regard to the tariff classification of in the present state of scientific knowledge to Alvityl, some guidance is given by Regu- state whether the criterion of concentration lation N o 210/85, which provides that multi- alone is always sufficient in order to be able vitamin and mineral pills with a specified to determine whether a vitamin preparation composition must be classified as food constitutes a medicinal product; still less preparations. The fifth recital in the pre- therefore is it possible to specify the level of amble to this regulation states that these concentration above which such a vitamin products have the characteristics of a food preparation would fall within the Commu- supplement containing vitamins and mineral nity definition of a medicinal product.' u salts and intended to keep the body in good (paragraph 28). health and that they should therefore be regarded as food preparations. The vitamin and mineral salt content indicated in Regu- lation N o 210/85 corresponds in large meas- ure to the recommendations of the Scientific Committee for Foodstuffs. 13 18. For the purpose of the tariff classifica- tion of a product as a pharmaceutical prod- uct, it must be assumed that the decisive cri- terion is whether the product has a therapeutic or prophylactic application. The wording of heading N o 30.04 of the Com- mon Customs Tariff and the explanatory notes thereon are very clear on this point. 20. The composition of Alvityl corresponds, The Court adopted the same approach in its so far as certain vitamins are concerned, t o judgment in Case C-177/91, 1 2 in which it the figures given in Regulation N o 210/85 found that 'hawthorn drops' should be clas- and mentioned in the recommendations of sified under heading N o 30.04 because that the Scientific Committee. This fact supports product had clearly defined therapeutic and, the argument that Alvityl is in principle a above all, prophylactic characteristics, the food product in the same way as the pills effect of which was concentrated on precise referred to in Regulation N o 210/85. functions of the human organism, namely the cardiac, circulatory and neuro-vegetative functions. 13 — Reports of the Sdentine Committee for Foodstuffs (Series 31). Food and Energy Supplements in the European Com- munity (report delivered on 11 December 1992). The values indicated relate to adults, men and women respectively. The Scientific Committee described these values as 'reference 11 — The case concerned the concept of 'medicinal product' in intakes for the populaùon'. This term means the intake Council Directive 65/65/EEC. which is sufficient for practically everyone in good health in 12 — Bioforce [1993] ECR 1-45, in particular paragraph 13. a given group.

Vitamin B2 (mg) 2.5 1.2 1.3-1.6

Vitamin B9 (mg) 0.0625 0.05 0.2

Vitamin D (IU) 500 200 400

23. As the table shows, Alvityl has a vitamin health. 1 4 On the other hand, this does not A content approximately three times that of appear to be the case with regard to vitamins the pills referred to in Regulation N o 210/85 B l , B2 and B9, which are also contained in and recommended by the Scientific Commit- Alvityl in greater proportions than in the tee. Moreover, Alvityl tablets contain more pills referred to in Regulation N o 210/85. vitamin D than the pills referred to in the regulation. The higher content of these vita- mins is noteworthy in that both vitamins A 14 — According to information supplied after the material time and D can be taken in excessive quantities in the present case, the content of vitamins A and D in Alvityl has been reduced to 1 500 and 150 IU respectively and this can have a detrimental effect o n to avoid the risk of hyper-vitaminosis (overdose).

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25. A comparison between the composition of Alvityl and that of the pills mentioned in Regulation N o 210/85 is therefore decisively in favour of the argument that Alvityl is a food, in the same way as the pills referred to in that regulation. Alvityl is thus not intended for specific pro­ phylactic or therapeutic use, as required by the Bioforce judgment cited above, and is in any case not suitable for that purpose.

26. As appears from the abovementioned report by Dr Rousseau, Alvityl is also used in the treatment of certain deficiencies, including those connected with an unbal­ anced diet, and in the treatment of symptoms 28. Consequently Alvityl cannot be classi­ fied under Chapter 30 of the Common Cus­ toms Tariff dealing with pharmaceutical 15 — On this point, see the Van Bennekom judgment, cited products, but must be regarded as a food above in footnote 9. preparation within the meaning of Chapter 16 — Source: Tableau des Calories, Anne Noel, Ed. S. A. E. P., Ingersheim, 1988. 21.

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Observations concerning Strongenol in par- Strongenol cannot be considered a pharma- ticular ceutical product either.

30. In addition to the copper just men- tioned, Strongenol also contains sodium, 29. Strongenol contains no vitamins and iron and iodine. Sodium is not listed in the only some of the numerous minerals which pills referred to in Regulation N o 210/85. By the body requires. The vitamins and most of analogy with Alvityl and the proportions of the minerals in the tablets indicated as being certain vitamins it contains, Strongenol also food preparations for the purposes of Regu- has a higher iron and iodine content than the lation N o 210/85 are therefore not present at food preparations referred to in Regulation all in Strongenol, which also has only a low N o 210/85 and than that recommended by copper content. In principle, therefore, the Scientific Committee, namely:

Notes relating to heading N o 30.04 of the 33. For these reasons Strongenol cannot Common Customs Tariff and, furthermore, be classified for tariff purposes under this product had no specific therapeutic or heading N o 30.04 or any other heading of prophylactic effect either, as required by the Chapter 30. Bioforce judgment.

Conclusion

34. In view of the foregoing, I p r o p o s e t h a t t h e C o u r t give the following reply t o the q u e s t i o n s u b m i t t e d for a preliminary ruling:

T h e C o m m o n C u s t o m s Tariff m u s t b e i n t e r p r e t e d as m e a n i n g t h a t t h e t e r m ' p h a r ­ maceutical p r o d u c t s ' used in C h a p t e r 30 d o e s n o t i n c l u d e p r o d u c t s having t h e c o m p o s i t i o n of t h e p r o d u c t s w h i c h are t h e subject of t h i s case.

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