C-270/96

2. Chapter 21 of the Common Customs Tar- iff covers 'Miscellaneous edible prepara- tions'. 3. Chapter 30 of the Common Customs Tar- iff covers 'Pharmaceutical products'.

Heading 2106 covers 'Food preparations not Heading 3004 covers 'Medicaments ... con- elsewhere specified or included'. sisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for * Original language: Danish. retail sale'.

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The Customs Co-operation Council's Note 1(a) in the introduction to Chapter 30 Explanatory Notes to Heading 3004 read as is worded as follows: follows:

'The provisions of the heading text do not ' 1 . This chapter does not cover: apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral waters (natural or arti- ficial), which fall to be classified under their own appropriate headings. This is essentially the case as regards food preparations con- taining only nutritional substances. The major nutritional substances in food are pro- (a) food or beverages (such as dietetic, dia- teins, carbohydrates and fats. Vitamins and betic or fortified foods, food supple- mineral salts also play a part in nutrition. ments, tonic beverages and mineral waters) (Section IV)'.

7. The Fonds d'Intervention et de Régulari- sation du Marché du Sucre which adminis- Each 2 gr tablet contains: ters the aid regulation in France does not, meanwhile, accept that they are pharmaceuti- cal products as referred to in Chapter 30 of the Common Customs Tariff but instead classified the products under Chapter 21 ('Miscellaneous Edible Preparations') and — arginine aspartate: 1 gr demanded repayment of the refunds paid out. Sarget contested that claim before the Tribunal (Administrative Court), Paris.

— excipients (citric acid, sodium bicarbon- ate, sodium carbonate, sodium dihydro- gen citrate, saccharin sodium, orange yellow (E 110), colloidal silica, flavour- ing): 1 gr'. 8. The Court has been informed that Sar- genor takes the form of chewable tablets, effervescent tablets and drinkable solutions 3 — OJ 1996 L 28, p. 7. in ampoules. The composition of active

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ingredients is the same in all three forms of 9. Dynamisan takes the form of a powder to Sargenor. An effervescent tablet of 1.966 g is be diluted in water and drinkable solutions made up as follows: in ampoules. The composition of the active ingredients is the same in both forms of Dynamisan. An ampoule of 10 ml consists of: active ingredients

— arginine-aspartate 1g active ingredients

— saccharin sodium — methyl parahdroxybenzoate

— orange yellow S

— propyl parahydroxybenzoate

— anhydrous colloidal silicon

— passion fruit flavouring — orange flavouring

— sodium 100 mg — purified water

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OPINION OF MR ELMER — CASE C-270/96

Procedure before the Court much more than the daily vitamin B 12 allow- ance of 1 µg recommended in Council Direc- tive 90/496/EEC on nutrition labelling for foodstuffs (OJ 1990 L 276, p. 40). Sarvit, which has not been marketed since 1987, contained 500 µg vitamin B, 2 , which is far above the daily allowance recommended in the above directive. Its vitamin B 12 content 13. Sarget and the French Government claim was so high that Sarvit could be used only that Sargenor, Dynamisan, Lysivit and Särvit for therapeutic or prophylactic purposes. fall under heading 3004 in the Common The French Government has stated in par- Customs Tariff. ticular that Lysivit and Sarvit are used in the treatment of functional asthenia, which is an illness. A lack of vitamin B 1 2can result in difficulties in the functioning of the nervous system, problems with heart muscle and res- piratory problems, as well as pernicious anaemia. Sarget has stated in particular that Sargenor, which contains arginine aspartate, the classification of Sargenor under heading has a therapeutic and prophylactic effect 2106 in Regulation N o 214/96 does not have against asthenia, which is an illness requiring retroactive effect. Sargenor is registered as a medical treatment. Sargenor has a specific medicament in France and eight European therapeutic and prophylactic effect on certain countries, as well as in approximately 40 functions of the human organism and con- other countries. tains arginine aspartate in a quantity such that it can only be used for therapeutic or prophylactic purposes. The same applies to Dynamisan, which has the same composition and effect as Sargenor, inasmuch as it con- tains arginine glutamate, which has the same therapeutic effects as arginine aspartate. Arginine aspartate is not without toxicologi- cal risk. Medical advice is required if a child under 12 years ingests it.

15. I would point out that Regulation N o 1010/86 provides the legal basis for granting production refunds for sugar used in the manufacture of the products listed in the annex to the regulation. The annex refers to 'Chapter 30 — Pharmaceutical products' of 17. The question must therefore be exam- the Customs Tariff, but not 'Chapter 21 — ined whether the products involved in this Miscellaneous edible preparations'. If the case have the characteristics and specific products properly fall under Chapter 21, properties referred to in heading 3004. they are therefore not covered by the regu- lation. It is only if the products fall under Chapter 30 that they are covered, and only in that case is there a basis for granting a production refund. The case before the national court therefore turns on whether the products fall under Chapter 30 of the 18. The decisive criterion for the classifica- Common Customs Tariff and the question tion of a given product as a medicament referred to the Court must therefore be under the Common Customs Tariff must be understood as a request to interpret that considered as being whether it has a specific chapter. therapeutic or prophylactic use. That is stated in the text to heading 3004 of the Common Customs Tariff and in the explana- tory notes thereto. In accordance with the above, in Case C-177/91 Bioforce I 6 the Court held that 'hawthorn drops' must be 16. Under the Court's settled case-law, in classified under heading 3004, since that the interests of legal certainty and ease of product has clearly defined therapeutic and, verification, the decisive criterion for the above all, prophylactic characteristics, the classification of goods for customs purposes effect of which is concentrated on precise is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the 4 — [1995] ECR I-1381. Common Customs Tariff and of the notes to 5 — [1995] ECR I-4759. the sections or chapters. Likewise, for the 6 — [1993] ECR I-45, in particular paragraphs 12 and 13.

20. In relation to the Customs Tariff what cannot be a deciding factor is how a given product stands in relation to the Community 'Inasmuch as vitamins are usually defined as or the individual Member States' legislation substances which, in minute quantities, form on medicaments. That also follows from the an essential part of the daily diet and are general observations relating to Chapter 30 indispensable for the proper functioning of of the Common Customs Tariff, where it is the body, they may not, as a general rule, stated: 'The description of a product as a be regarded as medicinal products 'when medicament in Community legislation ... or they are consumed in small quantities, (para- in the national legislation of the Member graph 26) States, or in any pharmacopoeia is not the

7 — [1997] ECR I-258!. 9 — The case concerned medicinal products for the purposes of 8 — [1983] ECR 3883. Directive 65/65/EEC.

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SARGET v FIRS

deciding factor in so far as its classification in Sargenor and Dynamisan this chapter is concerned.'

22. Sarget has produced a report on Sar- The fact that a product is marketed with genor drawn up by Professor P. Galley, of authorisation from the national authorities the Centre Régional de Gériatrie, Centre and is thus regarded as a medicament in the Hospitalier Universitaire, Bordeaux. It is national legislation does not therefore per se stated in p. 5 of that report that Sargenor has imply that the product should also be classi- been marketed in France since 1965 as a fied as a medicament under the Customs Tar- treatment for functional asthenia in the form iff. According to Case C-405/95 Bioforce II, of a course of 3 x 5 ml ampoules per day for it does, however, constitute evidence that it 15 to 30 days. O n p. 30 it is stated that the possesses the objective characteristics and dosage is 2 to 3 ampoules per day for adults properties defined in heading 3004. and 1/2 to 2 ampoules per day for children,

10 — OJ, English Special Edition 1965-1966, p. 20. 13 — According to the classification regulation, that classification 11 — See Case 227/82 Van Bennekom, cited in footnote 8, at has been made precisely in application of the general rules. paragraph 14. Thus the classification regulation states that classification is 12 — See Case 227/82 Van Bennekom, cited in footnote 8, para- determined by General Rules 1 and 6 for the interpretation graph 17, and Case C-112/89 Upjohn [1991] ECR I-1703, of the combined nomenclature, Note 1(a) to Chapter 30 paragraph 16, and Case C-219/91 Ter Voort [1992] ECR and the wording of C N codes 2106, 2106 90 and I-5485, paragraph 16. 2106 90 92.

23. In my view it is not the Court's task to decide whether asthenia is an illness which differs from general fatigue. A finding on 26. Asthenia manifests itself in many differ- that question would, moreover, not provide ent, more or less diffuse, symptoms, and the an answer to the question of how Sargenor said investigations of arginine aspartate also should be classified. Even were it to be suggest that Sargenor and Dynamisan could accepted that asthenia is an illness, it would be considered, according to their dosage, to still be of decisive importance for classifica- have an effect on a number of different func- tion purposes whether Sargenor has a clearly tions in the human organism. In my view, defined therapeutic or prophylactic effect on precisely on that ground, Sargenor and such a state. Dynamisan cannot be regarded as having such a clearly defined therapeutic or prophy- lactic effect as is required for classification under Chapter 30 of the Common Customs Tariff.

'Reports of the Scientific Committee for Sarvit can contribute to the treatment of per- Food (31st Series): Nutrients and energy nicious anaemia. intakes for the European Community' 14 is 1 µg. The vitamin B 1 2 content of Lysivit thus considerably exceeds the recommended daily intake. That is true to an even greater degree in the case of Sarvit, which contains 500 µg 29. According to the evidence, Lysivit and per ampoule. Sarvit are marketed as a treatment for func- tional asthenia. However, as stated above, asthenia manifests itself in many different, more or less diffuse, symptoms, and both products can therefore, as stated in point 26, 28. It was stated during the proceedings that be regarded as having an effect on a number a lack of vitamin B 1 2 can be linked to perni- of different functions in the human organ- cious anaemia, which is an illness character- ism. ised by the fact that the organism cannot absorb vitamin B 1 2 . According to the evi- dence, neither Sarvit nor Lysivit are mar- keted, however, as a treatment for pernicious anaemia. Furthermore, administration of 30. To summarise, Lysivit and Sarvit cannot vitamin B 1 2 in cases of pernicious anaemia therefore be said to have such a clearly takes place mainly by intramuscular injec- defined therapeutic or prophylactic effect as tion. Moreover, there is no evidence to show is required for classification under heading how the other active ingredients in Lysivit or 3004.

Conclusion

3 1 . I n view of t h e foregoing I w o u l d p r o p o s e t h a t t h e C o u r t rule o n t h e question referred t o it as follows: