C-106/94

* Original language: Danish. 1 — OJ 1986 L 94, p. 9. 2 — OJ 1988 L 152, p. 23.

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COLIN AND DUPRÉ

Customs Tariff Chapter 17 ('Sugar and sugar guaiacol (1.6 mg per g) and terpineol (1.6 mg confectionery') and the mixtures under per g). Common Customs Tariff Chapter 22 ('Bev- erages, spirits and vinegar') and demanded repayment of the refunds granted; they also brought criminal proceedings against the two companies' directors.

Every bottle of Sangart mixture is made up, according to the evidence, of distilled water (100 cm 3 ), syrup (25 cm 3 ) and 90° alcohol (16 cm 3 ) to which is added 0.005 g sodium arsenate, 0.02 g sodium nucleinate, 1 g nux vomica, 1.5 g calf liver extract and various 3. As far as the composition of the throat flavourings. pastilles is concerned, it was explained to the Court that red Pulmoll pastilles consist essentially of sugar, terpene (3.8 mg), men- thol (0.76 mg), amylocaine hydrochloride (0.152 mg), glycirrhizin (7.6 mg) and a bind- ing agent, flavouring and colouring.

100 g of Quintonine mixture contains, besides water, 96° alcohol and sugar, certain bitter and flavouring substances (cinnamon, cola, bitter orange, quinine), 0.033 g nux vomica and 0.068 g calcium glycerophos- phate.

'— May Commission Regulation (EEC) — Having regard to their composition, N o 717/85 of 19 March 1985 on the presentation and use do green Pulmoll classification of goods falling within pastilles fall within the scope of Com- subheading 17.04 D I of the Common mission Regulation (EEC) N o 717/85 of Customs Tariff be interpreted as mean- 19 March 1985 on the classification of ing that it refers to goods whose com- goods falling within subheading 17.04 D position (percentage by weight) is dif- I or within the scope of Chapter 30 of ferent from that indicated in Article 1 of the Common Customs Tariff "Pharma- that regulation? ceutical products" — 30-4?

— Having regard to its composition, pre- sentation and use does Sangart mixture fall within the scope of Chapter 30 of the Common Customs Tariff ("Pharma- — If the reply to the first question is in the ceutical products")? negative, must heading 30.04 of the Customs Nomenclature which refers to medicaments be interpreted as meaning that it includes a product which con- tains not only sugar but above all flavouring agents which may also have — Having regard to its composition, pre- medicinal properties in such propor- sentation and use does Quintonine fall tions that it is used essentially for ther- within the scope of Chapter 30 of the apeutic and prophylactic purposes?'

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COLIN AND DUPRÉ

The relevant tariff headings The Customs Cooperation Council's Notes on that position are identical to those relat- ing to the Harmonized System:

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OPINION OF MR ELMER —JOINED CASES C-106/94 AND C-139/94

prophylactic uses, the pastilles or drops fall Article 1 of the regulation is worded as fol- in heading 30.03.' lows:

'Anicie 1

The Nomenclature Committee states that Cough and throat-irritation pastilles having heading 17.04 includes inter alia cough drops the following composition (percentage by made up of sugar (99% approximately) to weight): which has been added small proportions of various substances such as menthol, eucalyp- tol, aniseed, tolu, coltsfoot, marrubium, ben- — sucrose, glucose and caramel: 99,50, zoin, etc. in a wrapping showing the com- mercial name of the product, its composition, and in some cases a drawing of — camphor: 0,007, a man coughing.

— menthol: 0,207,

7. Chapter 22 of the Customs Tariff is 'Medicaments (excluding goods of heading entitled 'Beverages, spirits and vinegar'. N o 3002, 3005 or 3006) consisting of mixed Heading 22.09 of the Customs Cooperation or unmixed products for therapeutic or pro- Council Nomenclature is identical to phylactic uses, put up in measured doses or heading 22.08 of the C N and covers in forms or packings for retail sale'.

'Undenatured ethyl alcohol of an alcoholic strength by volume of less than 80% vol; spirits, liqueurs and other spirituous bever- ages; compound alcoholic preparations of a The introductory Notes to Chapter 30 of the kind used for the manufacture of beverages'. Customs Cooperation Council Nomencla- ture state:

According to the Explanatory Notes, the heading covers:

'For the purposes of heading N o 30.03, "medicaments" means goods ... which are either:

'Spirituous beverages, sometimes referred to as food supplements, designed to maintain general health or well-being. They may, for example, be based on extracts from plants, fruit concentrates, lecithins, chemicals, etc., and contain added vitamins or iron com- (a) Products comprising two or more con- pounds.' stituents which have been mixed or com- pounded together for therapeutic or pro- phylactic uses; or

8. Chapter 30 of the Customs Tariff is headed 'Pharmaceutical products'. Heading 30.03 of the Customs Cooperation Council (b) Unmixed products suitable for such uses Nomenclature, entitled 'Medicaments put up in measured doses or in forms or (including veterinary medicaments)', corre- in packings of a kind sold by retail for sponds to C N heading 30.04, which covers therapeutic or prophylactic purposes.'

'... preparations put up as throat pastilles or cough drops, consisting essentially of sugars (whether or not with other foodstuffs such as gelatin, starch or flour) and flavouring agents (including such substances as benzyl alcohol, menthol, eucalyptol and tolu bal- sam) fall in heading 17.04 provided that 10. Daniel Dupré contends that Valda pas- whenever a flavouring agent could also have tilles are medicaments according to the medicinal properties its proportion in each French implementing legislation relating to pastille or drop is such that the preparation Council Directive 65/65/EEC of 26 January is not thereby given therapeutic or prophy- 1965 on the approximation of provisions laid lactic uses.' down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965- 1966, p. 20) and moreover in his view should also be regarded as medicinal products under the Court's case-law on the subject. Under Procedure before the Court Directive 65/65/EEC '[a] ny substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physi- ological functions in human beings or in ani- mals' is considered a medicinal product. That requirement as to 'mode of operation' is sat- isfied by Valda pastilles and their sugar con- 9. Patrick Colin states that red Pulmoll pas- tent is immaterial in that respect. At the same tilles certainly only contain low doses of time Valda pastilles satisfy the requirements active substances. What is decisive, however, of the directive with regard to their 'descrip- is that those substances together have a ther- tion' as a medicinal product, since the prod- apeutic effect and therefore the pastilles uct's packaging clearly sets out the recom- should fall under Chapter 30 of the Customs mended dose and its composition, and also Tariff relating to pharmaceutical products. the product is subject to the national rules The high sugar content is irrelevant in that connection. Sugar is very frequently used as a binding agent in products classified under Chapter 30. With particular reference to 7 — Case C-177/91 [1993] ECR I-45.

The Commission points out, for example, Opinion that menthol, which is contained in both Valda and Pulmoll pastilles, is a flavouring which certainly can have certain medicinal properties. It is only, however, if the sub- stance is present in such quantities that it has a therapeutic or prophylactic effect that this can result in classification under Chapter 30. The percentage by weight of menthol in Valda and Pulmoll pastilles is 0.0328% and 12. The questions in Case C-106/94 must be 0.076% respectively, that is to say, even understood as a request for an interpretation lower than in the pastilles referred to in of Chapter 30 of the Common Customs tar- Regulation N o 717/85 which are classified iff and not as asking for a customs classifica- under heading 17.04. tion of particular products.

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OPINION OF MR ELMER —JOINED CASES C-106/94 AND C-139/94

The concept of medicinal product as laid down in Council Directive 65/65/EEC, is 14. The description of the product is not therefore different from that of the Customs decisive. As Advocate General Gulmann Tariff. That directive 'is designed to eliminate stated in his Opinion in Case C-177/91 Bio- — at least in part — obstacles to trade in force, 9 it is 'clear that the presentation of a proprietary medicinal products within the product is not in itself sufficient for it to be Community whilst at the same time attaining regarded as a medicinal product. To allow the essential objective of safeguarding public the presentation of a product in itself to be health'. 10 In order to promote trade and at decisive for its tariff classification might the same time protect public health the cause a product to be covered by a customs directive makes a relatively broad range of heading merely on grounds of a special pre- products subject to the supervision laid sentation, even though its objective proper- down in the medicinal products legislation. ties did not correspond to the criteria laid down in the relevant heading. That would conflict with the principle of legal certainty and might lead to arbitrary discrimination'.

16. In contrast, the criterion for tariff classi- fication as a medicinal product is its thera- 15. Nor, in relation to the Customs Tariff, is peutic or prophylactic application. The it decisive how a given product stands in Explanatory Notes to both heading 30.03 relation to the Community or individual in the Customs Cooperation Council

17. That point of principle also underlies Commission Regulation N o 717/85 to which the questions refer. That regulation classifies certain cough and throat-irritation pastilles containing substances which in certain dos- Thus red Pulmoll pastilles contain, for ages may have medicinal properties under instance, the substance terpene and Valda heading 17.04. pastilles contain thymol. Despite the fact that those substances, according to the medical evidence available, may in certain doses have a therapeutic or prophylactic effect as a medicinal product, it must, however, be noted that they are present in such low quantities in the pastilles in question that That regulation may not, moreover, be even with the maximum daily intake of pas- regarded as stating anything more than that a tilles recommended on the packing, they. certain specific product with a certain spe- would have no effect of that sort. .12 The cific composition is covered by heading throat pastilles should therefore be classified 17.04 and it does not indicate the heading under Chapter 17, heading 17.04 'Sugar con- under which throat pastilles with a different fectionery, not containing cocoa', since no composition are to be classified. objective characteristics have been shown to indicate that they fall under any other chap- ter and tariff headings.

The first question from the Tribunal de Grande Instance, Paris, as to whether Regu- lation N o 717/85 refers to goods whose composition (percentage by weight) is differ- 19. The principal ingredients of Sangart- ent from that indicated in Article 1 of that mixture and Quintonine are distilled water, regulation should therefore be answered in the negative. 12 — According to Martindale, The Extra Pharmacopoeia, Lon- don, 1989, the recommended daily dose of terpene is, for example, 500-800 mg, and thymol is effective in a daily dose of 3 g. Red P u l m ó l lpastilles contain 3.8 mg terpene and 11 — See paragraph 8 above. Valda-pastilles 1.6 mg thymol.

Conclusion

I n v i e w of the foregoing I w o u l d p r o p o s e that the C o u r t reply t o the questions referred to it as follows:

— C o m m i s s i o n R e g u l a t i o n ( E E C ) N o 717/85 of 19 M a r c h 1985, as a m e n d e d b y C o m m i s s i o n R e g u l a t i o n ( E E C ) N o 2723/90 of 24 S e p t e m b e r 1990, s h o u l d be i n t e r p r e t e d as m e a n i n g that it d o e s n o t cover g o o d s w h o s e c o m p o s i t i o n (per- centage b y w e i g h t ) is o t h e r t h a n that referred t o in Article 1 of t h e Regulation.

— T h e C o m m o n C u s t o m s Tariff s h o u l d be i n t e r p r e t e d as m e a n i n g that the defi- nition of ' P h a r m a c e u t i c a l p r o d u c t s ' in C h a p t e r 30 d o e s n o t include t h r o a t p a s - tilles a n d m i x t u r e s w i t h t h e c o m p o s i t i o n of the p r o d u c t s in q u e s t i o n in this case.

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