61995J0405

Common Customs Tariff - Tariff headings - Echinacea purpurea extract-based drops - Product for therapeutic and prophylactic use - Classification under heading 3004 of the Combined Nomenclature

The Common Customs Tariff is to be interpreted as meaning that Echinacea purpurea extract-based drops should be classified under heading 3004. The curative or prophylactic properties of that product as well as the way in which it is packaged, dispensed and marketed are in themselves such as to cause it to be regarded as a product possessing the characteristic properties of a medicament. In the Member States in which it is marketed the product in question is, moreover, authorized to be put on the market as a medicament or, at the very least, has been the subject of an application for authorization to that end. Furthermore, however great the alcohol content of the product in question it does not alter its nature, since the alcohol acts as an adjuvant, preservative and vehicle for that product.

In Case C-405/95,

REFERENCE to the Court under Article 177 of the EC Treaty by the Finanzgericht München (Germany) for a preliminary ruling in the proceedings pending before that court between

Bioforce GmbH

and

Oberfinanzdirektion München

on the interpretation of headings 3004 and 2208 of Annex I to Commission Regulation (EEC) No 2551/93 of 10 August 1993 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1993 L 241, p. 1), on the classification of echinacea extract drops,

THE COURT

(First Chamber),

composed of: L. Sevón, President of the Chamber, D.A.O. Edward and M. Wathelet (Rapporteur), Judges,

Advocate General: A. La Pergola,

Registrar: H. von Holstein, Deputy Registrar,

after considering the written observations submitted on behalf of:

- Bioforce GmbH, by Berthold Widemann, of the Constance Bar;

- the Commission of the European Communities, by Francisco de Sousa Fialho, of its Legal Service, and Hans-Jürgen Rabe, Rechtsanwalt, Hamburg,

having regard to the Report for the Hearing,

after hearing the oral observations of Bioforce GmbH and the Commission at the hearing on 29 January 1997,

after hearing the Opinion of the Advocate General at the sitting on 6 March 1997,

gives the following

Judgment

1 By order of 14 December 1995, received at the Court on 27 December 1995, the Finanzgericht München (Financial Court, Munich) referred to the Court for a preliminary ruling under Article 177 of the EC Treaty two questions on the interpretation of headings 3004 and 2208 of Annex I to Commission Regulation (EEC) No 2551/93 of 10 August 1993 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1993 L 241, p. 1, `the CCT'), on the classification of echinacea extract drops.

2 Those questions were raised in proceedings between Bioforce GmbH (`Bioforce') and the Oberfinanzdirektion München (Principal Revenue Office, Munich) concerning the tariff classification of two categories of products, namely `Echinaforce' and Echinacea Drops.

3 According to the details contained in the application for an official notice of tariff classification lodged with the German authorities and in the information notices included with the products at issue, those products consist of a fresh herbal tincture made up of 95% Echinacea purpurea e herba and 5% Echinacea purpurea e radice with an alcoholic strength of 65% by volume. The preparations are offered for retail sale in packages mentioning their composition, spheres of application and recommended dosage.

4 It is apparent from the order for reference that:

- `Echinacea Drops' are used for preventive purposes to protect users at times of increased risk of infection from colds and to strengthen the body's resistance to feverish colds; unless otherwise prescribed, the recommended dose is 20 drops three times a day, diluted in water;

- the product `Echinaforce' also reinforces the body's defences in case of colds and chronic infections which are unlikely to clear up; in addition, it is used for preventive purposes in cases of increased risk of infection against debility with delayed general recovery after infection (convalescence); it may also be used externally for skin conditions; unless otherwise prescribed, the recommended dose is 20 drops three times a day as a prophylactic and 20 to 30 drops five times a day in acute conditions; the information notice also lists contraindications.

5 The Oberfinanzdirektion München issued an official customs tariff notification in which it stated that the preparations in issue could not be classified as medicaments under heading 3004 of the Combined Nomenclature (`CN'), because in its opinion the active substances in Echinacea have not as yet found general recognition. On the other hand, Bioforce maintained that the prophylactic effects, accepted in scientific circles, of taking echinacea-based products are an unanswerable argument in favour of their classification under heading 3004. It added that those products, when imported, were put up in packings for retail sale for therapeutic or prophylactic uses.

6 In view of its doubts as to the interpretation of the CCT, the Finanzgericht München decided to refer the following questions to the Court:

`(1) Is the Common Customs Tariff - Combined Nomenclature 1994 - to be interpreted as meaning that products such as Echinacea Drops (extract of echinacea purpurea e herba and e radice in 56.1% alcohol by weight, for protection against colds and influenza and for strengthening resistance to colds) are to be classified under heading 3004 - Medicaments consisting of unmixed products for therapeutic or prophylactic uses, put up ... for retail sale?

(2) If not, is the Common Customs Tariff to be interpreted as meaning that products such as those referred to in Question 1 are to be classified as "other" spirituous beverages under subheading 2208 90 69?'

Question 1

7 In answering this question, it should first of all be borne in mind that heading 3004 of the CCT covers

`Medicaments (...) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale'.

8 Furthermore, it follows from Note 1(a) of the introductory notes to Chapter 30 of the CCT that that chapter does not cover `food supplements'.

9 There are also explanatory notes drawn up by the Customs Cooperation Council and by the Harmonized System Committee which, as the Court has already stated, may be an important aid to the interpretation of the scope of the various tariff headings but do not have legally binding force (see Case 200/84 Daiber [1985] ECR 3363, paragraph 14, and Joined Cases C-106/94 and C-139/94 Colin and Dupré [1995] ECR I-4759, paragraph 21).

10 Accordingly, under Note 1(b) of the explanatory notes of the Customs Cooperation Council concerning heading 3004:

`This heading covers medicaments consisting of mixed or unmixed products, provided they are:

[put up]

(...)

(b) in packings for retail sale for therapeutic or prophylactic use. This refers to products (...) which, because of their packaging and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.'

11 It is also clear from the explanatory notes of the CN, Chapter 30, `General', that

`The description of a product as a medicament 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 pharmacopoeia is not the deciding factor in so far as its classification in this chapter is concerned'.

12 It should next be recalled that it is settled case-law that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the CCT and of the notes to the sections or chapters (see, in particular, Colin and Dupré, cited above, paragraph 22).

13 It should therefore be considered whether the products in question have the objective characteristics and properties defined in heading 3004 of the CCT which, as the Court held in Case C-177/91 Bioforce [1993] ECR I-45, paragraph 9, must be interpreted in the light of medical developments.

14 It should be noted first that, as is clear from the documents in the file in the main proceedings and from the observations made at the hearing before the Court, in the course of both therapeutic and prophylactic application and in appropriate dosages, use of the products in question is recommended, in particular, to strengthen the body's defences against feverish colds and, more particularly in the case of `Echinaforce', against chronic inflammations and infections, cases of increased risk of infection and debility after infectious diseases and also against skin diseases.

15 Whatever the actual therapeutic or prophylactic value of the products in question, it must be held that the description of the curative or prophylactic properties of those products as well as the way in which they are packaged, dispensed and marketed is in itself such as to cause them to be regarded as products possessing the characteristic properties of a medicament and, by correlation, to exclude the possibility that they might be used for purposes other than those of a therapeutic or prophylactic nature.

16 The fact that, as is apparent from the replies of Bioforce and the Commission to the questions put to them by the Court, in the Member States in which they are marketed the products in question are, moreover, authorized to be put on the market as medicaments or, at the very least, have been the subject of an application for authorization to that end constitutes further evidence that they possess the objective characteristics and properties defined in heading 3004 of the CCT.

17 Finally, it should be remarked, as is also clear from the documents in the file in the main proceedings, that however great the alcohol content of the products in question it does not alter their nature, since the alcohol acts as an adjuvant, preservative and vehicle for those products.

18 It follows from those considerations that the products in point cannot be regarded as food supplements within the meaning of paragraph 1(a) of the introductory notes to Chapter 30 of the CCT, or as spirituous beverages designed to maintain general health or well-being within the meaning of paragraph 14 of the explanatory notes of the Customs Cooperation Council on heading 2208, but are to be regarded as products with a clearly defined therapeutic or prophylactic purpose with an effect concentrated on the functions of the human body's immune system.

19 The Court must therefore reply that the CCT is to be interpreted as meaning that Echinacea purpurea extract-based drops should be classified under heading 3004.

Question 2

20 In view of the reply to the first question referred by the national court, there is no need to answer the second question.

Costs

21 The costs incurred by the Commission of the European Communities, which has 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.

On those grounds,

THE COURT

(First Chamber),

in answer to the questions referred to it by the Finanzgericht München by order of 14 December 1995, hereby rules:

The Common Customs Tariff, in the version established in Annex I to Commission Regulation (EEC) No 2551/93 of 10 August 1993 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff must be interpreted as meaning that Echinacea purpurea extract-based drops must be classified under heading 3004.