C-270/96

JUDGMENT OF 12. 3. 1998 — CASE C-270/96

J U D G M E N T O F T H E C O U R T (Fourth Chamber) 12 March 1998*

In Case C-270/96,

R E F E R E N C E to the Court under Article 177 of the E C Treaty by the Tribunal Administratif, Paris, for a preliminary ruling in the proceedings pending before that court between

Laboratoires Sarget SA

and

composed of: R. Schintgen, President of the Second Chamber, acting for the Presi- dent of the Fourth Chamber, P. J. G. Kapteyn and J. L. Murray (Rapporteur), Judges,

Advocate General: M. B. Elmer, Registrar: L. Hewlett, Administrator,

after considering the written observations submitted on behalf of:

— Laboratoires Sarget SA, by François Meunier and Jean-Claude Demoulin, of the Paris Bar,

— the French Government, by Catherine de Salins, Head of Subdirectorate in the Legal Affairs Directorate of the Ministry of Foreign Affairs, and Frédéric Pascal, Central Administrative Attaché in the same Directorate, acting as Agents,

— the Commission of the European Communities, by Michel Nolin, of its Legal Service, acting as Agent,

Judgment

1 By judgment of 12 June 1996, received at the Court on 8 August 1996, the Tribu- nal Administratif (Administrative Court), Paris, referred for a preliminary ruling under Article 177 of the EC Treaty a question on the interpretation of Council Regulation (EEC) N o 1010/86 of 25 March 1986 laying down general rules for the production refund on certain sugar products used in the chemical industry (OJ 1986 L 94, p. 9), as amended by Article 9 of Commission Regulation (EEC) N o 1714/88 of 13 June 1988 amending certain Regulations concerning the applica- tion of the common market organisation for sugar following the introduction of the Combined Nomenclature (OJ 1988 L 152, p. 23), and on the interpretation of Chapter 30 of the Combined Nomenclature, as established by Annex I to Council Regulation (EEC) N o 2658/87 of 23 July 1987 on the tariff and statistical nomen- clature and on the Common Customs Tariff (OJ 1987 L 256, p. 1, hereinafter 'the CN').

2 That question has arisen in the course of proceedings between Laboratoires Sarget SA (hereinafter 'Sarget') and the Fonds d'Intervention et de Régularisation du Marché du Sucre (Sugar Market Intervention and Stabilisation Fund, hereinafter 'the FIRS') concerning repayment of production refunds granted to Sarget as an undertaking using sugar in the manufacture of certain chemical products.

3 Regulation N o 1010/86, as amended by Article 9 of Regulation N o 1714/88 fol- lowing the introduction of the C N , deals with the granting of refunds to undertak- ings that use sugar in the manufacture of certain chemical products.

7 By letter of 15 November 1988 Sarget applied for approval to be renewed for the same products, which it then declared as falling under C N heading 3004. Pursuant to that declaration, further approval was given on 17 November 1988.

8 After analysing samples of Sargenor, Lysivit, Sarvit and Dynamisan, the French customs and excise authorities started proceedings against Sarget on 22 June 1990 on the basis that those products should be classified under C N Chapter 21 as

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JUDGMENT OF 12. 3. 1998 — CASE C-270/96

'Miscellaneous edible preparations', a chapter which is not included in the annex to Regulation N o 1010/86, as amended, and which therefore covers products not qualifying for production refunds.

9 Subsequently, on 17 February 1995, the FIRS issued Sarget with an enforceable demand for FF 2 545 059.66, corresponding to refunds that it had wrongly received between 1989 and 1991.

13 A specific product may thus come within the scope of Regulation N o 1010/86, as amended by Article 9 of Regulation N o 1714/88, only if it is classifiable under one of the C N headings listed in the annex to that regulation.

1 4 In a case such as that in the main proceedings here, it appears that, of the various chapters, headings and subheadings mentioned in the annex to that regulation, Chapter 30 alone is relevant.

15 The question referred to the Court must therefore be construed as seeking to ascertain whether products composed of ingredients identical to those contained in Sargenor, Lysivit, Sarvit or Dynamisan, and in the same proportions, fall under Chapter 30 of the C N and consequently under Regulation N o 1010/86, as amended by Article 9 of Regulation N o 1714/88.

19 Within this latter section, Chapter 21 of the C N is entitled 'Miscellaneous edible preparations'.

20 According to the relevant Explanatory Notes of the Customs Cooperation Coun- cil, heading 2106, entitled 'Food preparations not elsewhere specified or included', comprises, inter alia, preparations, often referred to as food supplements, based on extracts from plants, fruit concentrates, honey, fructose, etc. and containing vita- mins and sometimes minute quantities of iron compounds. However, those notes also state that similar preparations intended for the prevention or treatment of dis- eases or ailments are excluded from that chapter and come under headings 3003 or 3004 of the C N .

21 Sarget states that Sargenor is registered as a medicament not only in France and in eight Member States but also in 40 other countries in the world. It further consid- ers that the definition of 'medicinal product' 1 in Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, L 229, p . 20) is very close to that given in the case-law of the Court concerning the decisive criteria for the tariff classification of goods in the C N . It considers that compliance with the principle of legal certainty would not be jeopardised if, in this case, the Court took into account inter alia the

1 — Translator's note: 'médicament' is translated as 'medicinal product' in Council Directive 65/65/EEC, but as 'medicament' in the CN.

23 The concept of a pharmaceutical product in the C N is distinct from that of a medicinal product referred to 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 Wan Bennekom [1983] E C R 3883, para- graph 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] E C R I-1487, para- graphs 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 if it displays the characteristics of such a product. The Court also recognised in that case that, so long as harmonisation 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.

24 In contrast, the eighth recital in the preamble to Regulation N o 2658/87 provides that 'it is essential that the combined nomenclature and any other nomenclature wholly or partly based on it ... should be applied in a uniform manner by all the Member States'. The provisions of the C N must therefore be given an identical interpretation by each of the Member States.

29 It is therefore necessary to examine whether the products in question have thera- peutic and prophylactic characteristics and, in particular, whether they are capable of being applied in the prevention or treatment of diseases or ailments.

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SARGET v FIRS

Sargenor and Dynamisan

30 The file shows that at the material time Sargenor existed in three different forms: chewable tablets, effervescent tablets, and a drinkable solution in ampoules, their active ingredients being in principle identical. It appears from the clinical expert's report on Sargenor, which was annexed to Sarget's observations, that a drinkable 5 ml ampoule of Sargenor contained 1 g of arginine-aspartate as the single active ingredient, excipients and sodium.

31 The report also states that adult dosage is two to three ampoules per day and the dosage for children over 30 months one-half to two ampoules per day, according to age. The report adds that as regards arginine-aspartate, exceeding that dosage (either by doubling or tripling the recommended quantity) would, according to the available data, have no harmful effect.

35 Sarget and the French Government emphasise that there are differences between asthenia and fatigue. In their view, fatigue is a state of lassitude following over- work or prolonged effort, whereas asthenia is severe and generalised weakness hav- ing no relationship of cause and effect to work or effort.

36 That distinction between asthenia and fatigue was contested by the Commission at the hearing. It maintains that certain doctors consider that asthenia is a state of fatigue.

37 It is not for the Court to establish whether asthenia is a pathological condition distinguishable from normal fatigue. Even if asthenia could be regarded as a patho- logical condition, that would not be decisive for the purposes of ascertaining whether Sargenor and Dynamisan have clearly-defined therapeutic and prophylac- tic characteristics, the effect of which is concentrated on precise functions of the human organism, and are capable of being applied in the prevention or treatment of diseases or ailments.

38 It appears from the national court's file that the studies submitted by Sarget and those to which the French Government refers in its observations concern the effect of arginine or arginine-aspartate in various aetiologies and not that of Sargenor or Dynamisan. Moreover, those studies relate, principally, to the effects of arginine and arginine-aspartate on certain pathological conditions, such as cancer, that nei- ther Sargenor or Dynamisan are intended to treat. In any case, Sarget has not established a link between Sargenor and Dynamisan, on the one hand, and the studies on the effects of arginine and arginine-aspartate in the treatment of the pathological conditions dealt with in those studies, on the other.

42 Lysivit dosage for children is one to three ampoules of 5 ml per day. That dosage gives, on average, 30 µg of vitamin B 1 2 per day. Adult dosage is one to four ampoules of 10 ml per day, or an average dosage of two ampoules of 10 ml per day, representing 60 µg of vitamin B 1 2 per day, and may go up to 120 µg of vitamin B12 P e r day. For the sake of comparison, the daily vitamin B 1 2 intake recom- mended in the Reports of the Scientific Committee for Food (Thirty-first series), 'Nutrient and energy intakes for the European Community' is 1 µg. Lysivit's vita- min B 1 2 content is therefore well in excess of the recommended daily intake.

43 The French Government maintains that Lysivit is used in the treatment of func- tional asthenia.

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44 Sarvit, which has not been marketed since 1987, used to be presented in the form of drinkable ampoules for adults of 5 or 10 ml. Its composition included 500 µg of vitamin B 1 2 per ampoule of 10 ml and 250 µg of vitamin B 1 2 per ampoule of 5 ml. Sarvit ampoules also contained amino acids and preservatives. Sarvit's vitamin B 12 content also exceeded the recommended daily intake.

45 The French Government maintains that Sarvit was used in the treatment of func- tional asthenia.

so In the light of the foregoing considerations, the answer to the question submitted must therefore be that products consisting of ingredients identical to those con- tained in Sargenor, Dynamisan, Lysivit and Sarvit and in the same proportions can- not be classified under heading 3004 of the C N as established in Annex I to Regu- lation N o 2658/87, and consequently do not come within the scope of Regulation N o 1010/86, as amended by Article 9 of Regulation N o 1714/88.

Costs

si The costs incurred by the French Government and by the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, for the parties to the main proceedings, a step in the proceedings pending before the national court, the decision on costs is a matter for that court.

O n those grounds,

T H E C O U R T (Fourth Chamber),

in answer to the question referred to it by the Tribunal Administratif, Paris, by judgment of 12 June 1996, hereby rules:

R. Grass H. Ragnemalm

Registrar President of the Fourth Chamber

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