OPINION OF ADVOCATE GENERAL

delivered on 15 September 1992 (*1)

Mr President,

Members of the Court,

1.This case concerns the classification of a hawthorn extract in the Common Customs Tariff. The case was referred to the Court by the Bundesfinanzhof, which is requesting an interpretation of the Customs Tariff in order to decide whether the product in question is to be classified under heading 30.04, which covers medicaments, or if not under heading 22.08, which covers spirituous beverages. (1)

2.The plaintiff in the main proceedings, Bioforce GmbH, has contested the binding tariff ruling given by the Oberfinanzdirektion München (Regional Tax Office, Munich) of the product ‘Weissdorn-Tropfen’ (hawthorn drops), an extract of the plant hawthorn with added alcohol (45.9% vol.), which Bioforce GmbH imports from Switzerland. The product is presented as a preparation to be used: ‘For treatment of the heart and to aid cardiac irrigation ... encourages cellular activity in the cardiac muscle, thus improving the blood supply to the coronary vessels’. The German customs authorities refused to classify the product under heading 30.04 and classified it instead under heading 22.08.

Interpretation of heading 30.04 of the Common Customs Tariff

3.The first question concerns the interpretation of heading 30.04 with regard to the classification of the product just described.

The concept of ‘medicaments for therapeutic or prophylactic uses’

4.Chapter 30 of the Common Customs Tariff covers pharmaceutical products. Headings 30.03 and 30.04 cover ‘medicaments ... for therapeutic or prophylactic uses’. The difference between the two headings is not of decisive importance in this case and it is agreed that it is the interpretation of heading 30.04 which is relevant. Heading 30.04 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.’

It may be seen from Note 1(a) of the introductory notes to Chapter 30 that it does not cover

‘foods or beverages such as dietetic, diabetic or fortified foods, food supplements, tonic beverages, spa water’.

Such products come under other tariff headings which correspond to the description of their objective properties. For example, spirituous beverages designed to maintain general health, according to the Explanatory Notes to the Harmonized System, (2) come under heading 22.08.

That distinction between medicaments and preparations designed to maintain general health defines the field of application of Chapter 30 in relation to the other provisions of the Customs Tariff. It is clear from that distinction that the concept of medicaments within the meaning of the Customs Tariff covers only preparations used for preventing or treating a specific ailment, whilst preparations which, because they aim at maintaining a general state of health, have a wider field of application and whose effect is therefore not clearly defined, fall outside the concept of medicaments.

That understanding of the concept of medicaments within the meaning of the Customs Tariff also finds support in the actual wording of heading 30.04. The use of the concepts ‘prophylactic’ and ‘therapeutic’ must lead to the conclusion that the prophylactic or therapeutic effect is well-defined and directed at a given ailment. It is meaningful to speak of a preparation's preventive or curative effect only if the ailment to be prevented or cured is well defined.

The question whether a preparation comes under the concept of ‘medicament’ within the meaning of the Customs Tariff therefore depends on whether, from the available scientific information it is well substantiated that the preparation is designed for prophylactic or therapeutic use — that is, whether the ailment for which the preparation is designed is well defined and whether the preventive or curative effect of the preparation is specifically designed for the ailment in question.

In deciding that, it is, according to the case-law of the Court, (3) the objective properties of the product at issue to which importance must be attached. That is in the interests partly of legal certainty and partly of a simplification of customs checks and also allows speedier and more economical administration.

The importance of the presentation of the product

5.There is agreement between Bioforce GmbH and the Commission that the product at issue, by its form and packing (including its packaging, description, posology and container) is presented as a medicament.

It may be seen from the actual wording of heading 30.04 that the product in question must be put up (in measured doses) or in forms or packings for retail sale. This covers, according to Note 1(b) of the Explanatory Notes to the Harmonized System on heading 30.04, medicaments which, because of their packing and in particular the presence of appropriate indications of the properties of the product, are clearly intended for sale direct to users without repacking.

It may therefore be a condition for classification of a product under heading 30.04 that it is put up for retail sale, but it is clear that the presentation of a product is not in itself sufficient for it to be regarded as a medicament. To allow the presentation of a product in itself to be decisive for its tariff classification might cause a product to be covered by a customs heading merely on grounds of a special presentation, even though its objective properties 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.

The importance of the fact that the product ‘Weissdorn-Tropfen’ is covered by German legislation on medicaments and recognized by the Bundesgesundheitsamt

6.Bioforce GmbH claims that decisive importance must be attached to the fact that the product ‘Weissdorn-Tropfen’ is recognized as a medicament by German legislation.

7.There are various reasons for rejecting this argument. It may be seen straight away from the general observations relating to Chapter 30 in the Explanatory Notes to the Harmonized System that

‘The description of a product as a medicament in Community legislation ... 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’.

The Commission is, moreover, correct in saying that the concept of medicinal product laid down in Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (4) differs from the concept of medicament in the Customs Tariff since the directive, to protect public health, allows a relatively broad choice of products to be included in the monitoring system laid down in the legislation on medicinal products. Thus that directive covers also products which by their designation are presented as medicinal products, whereas the designation of a product, as previously mentioned, is not a property to which, in itself, decisive importance may be attached for tariff classification. As the Court stated in the judgment in Case 227/82 *Van Bennekom,* (5) the directive seeks to protect consumers not only from harmful or toxic medicinal products but also from a variety of products used instead of the proper remedies. Heading 30.04 of the Customs Tariff, on the other hand, covers only products which are actually intended for therapeutic or prophylactic use.

To allow the considerations governing recognition as a medicinal preparation in national legislation on such preparations to be decisive would conflict with the principle of legal certainty, according to which customs classification is based on the objective properties of the product. Directive 65/65/EEC allows the national authorities a certain discretion to determine which products are to be covered by the national rules on approval and it is possible that the same product may be regarded as a medicinal product in one Member State but not in another. Thus identical products might be classified differently depending on whether or not Member States recognize products as medicinal products.

The alleged discrimination against phytotherapeutic products

8.Bioforce GmbH claims that the classification of the product ‘Weissdorn-Tropfen’ under a heading other than 30.04 would represent a disregard of the principle of equal treatment since such a classification would discriminate against phytotherapeutic products in contrast to synthetic (chemically produced) products.

In this connection it is important to stress that in this case the Court of Justice cannot express any view as to whether phytotherapeutic products as such may be regarded as medicaments within the meaning of the Customs Tariff, but merely whether the objective properties of the product ‘Weissdorn-Tropfen’ are of such a nature, according to the information available, that they require the product to be classified under heading 30.04. For classification under heading 30.04 it is not decisive whether a product is produced on the basis of one substance or another. What is decisive is the effects of the product in relation to treatment of illness. A plant-based medicament may be classified under heading 30.04 just as may a synthetic medicament which is used prophylactically or therapeutically.

Bioforce GmbH's argument that a classification under any heading other than 30.04 would constitute inappropriate discrimination is therefore unfounded.

Whether the product ‘Weissdorn-Tropfen’ is a medicament within the meaning of heading 30.04

9.From the information available it appears that the main field of application of the product ‘Weissdorn-Tropfen’ is present-day degenerative cardiac ailments and primarily conditions which cannot be regarded as actual illnesses but where there is an age-related reduction in cardiac capacity. The product therefore seems to be intended for cardiac and circulatory functions as such. That also emerges from the description of how the product works, namely treating the heart by aiding coronary irrigation and encouraging cellular activity in the cardiac thus allowing more blood to reach the coronary vessels. These explanations seek to show the generally beneficial effect of the product on the general state of health, particularly for the cardiac and circulatory functions in conditions which cannot be regarded as well-defined illnesses but rather as a sign of a general weakening of these functions, especially on grounds of age.

The sphere of application of the product ‘Weissdorn-Tropfen’ may therefore be described as broad, which is characteristic of ‘mild’ phytotherapeutic products to which ‘Weissdorn-Tropfen’ belong. It cannot be regarded as established that the product is designed for a specific illness and also the effect of the product is not sufficiently specific. The product cannot therefore be described as a medicament intended for the prophylactic or therapeutic treatment of a specific illness.

As the objective properties of ‘Weissdorn-Tropfen’ thus do not meet the criteria laid down in heading 30.04, the preparation cannot be classified under heading 30.04.

Interpretation of heading 22.08 of the Customs Tariff

10.The Bundesfinanzhofs second question relates to the question whether the product ‘Weissdorn-Tropfen’, if it does not come under heading 30.04, is to be classified under heading 22.08.90.59.

11. Heading 22.08 of the Common Customs Tariff covers

‘undenatured ethyl alcohol of an alcoholic strength by volume of less than 80% vol; spirits, liqueurs and other spirituous beverages; compound alcoholic preparations of a kind used for the manufacture of beverages’.

Subheading 22.08.90.59 covers

‘other spirituous beverages ... in containers holding 2 litres or less’.

In its judgment in Case 114/80 *Ritter v Oberfinanzdirektion Hamburg* (6) the Court stated that the concept of beverage within the meaning of the Customs Tariff signifies

‘any liquid suitable and intended for human consumption regardless of the quantity in which it is absorbed, or the special purposes for which various kinds of liquids may be consumed’.

The Court specified in the judgment that the scope of that concept must be determined on the basis of objective and verifiable criteria and cannot therefore be made dependent on purely subjective, variable factors such as the manner in which the product is taken or the purpose for which it is consumed. No importance can therefore be attached to the fact that the product ‘Weissdorn-Tropfen’ is intended to be consumed in the form of drops or that the product is consumed for its beneficial effect on the organism. That also emerges from the Explanatory Notes to the Harmonized System. According to point (14) of those notes, heading 22.08 covers

‘spirituous beverages, sometimes referred to as food supplements, designed to maintain general health or well-being’.

12.The plaintiff has claimed that the product ‘Weissdorn-Tropfen’ does not belong to heading 22.08 since the alcohol content is not characteristic of it but serves only as an additive, an excipient, a preservative and a vehicle.

No importance can be attached to that argument. As I stated, it is only the objective properties of the product to which importance may be attached for classification. Irrespective of the function of the alcohol and whether or not it is characteristic of the product, it is not contested that the product has an alcohol content of 45.9% vol. It cannot therefore be classified under the headings in Chapter 22, which covers non-alcoholic beverages. It may be seen, further, from Note 1(d) to the introductory notes to Chapter 13 of the Customs Tariff, which covers *inter alia* plant extracts, that the alcohol content of the preparation excludes classification under heading 13.02.

13.The objective properties of the preparation thus justify its classification under heading 22.08, since it is a spirituous liquid suitable and intended for drinking. More precisely, the preparation should be classified under heading 22.08.90.59 — ‘other spirituous beverages in containers holding 2 litres or less’.

Conclusion

14.I shall accordingly propose to the Court that the question referred to it should be answered as follows:

The Common Customs Tariff must be interpreted as meaning that a product such as ‘Weissdorn-Tropfen’ (an extract of hawthorn with 45.9% vol. alcohol), which is used as a tonic, must be classified not under heading 30.04 but under heading 22.08.90.59.

(*1) Original language: Danish.

(1) The questions concern the Common Customs Tariff as published as the Annex to Commission Regulation N° 2886/89 of 2 August 1989 amending Annex I to Council Regulation (EEC) N° 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1987 L 282, p. 1).

(2) The Explanatory Notes, accordine to the case-law of the Court, constitute an important factor for interpretation enabling the scope of the various tariff headings or subheadings to be defined or clarified. Reference is made to the judgments in Case 183/73 Girant v Oberfinanzdirektion [197-1] ECR 477 and in Case 54/79 Hako-Schuh v Hauptzollamt Frankfurt am Mam-Ost [1980] ECR 311.

(3) Judgment in Case 40/88 Weber v Milchwerke Paderborn-Rimbeck [1989] ECR 1395 and the judgments referred to in Advocate General Tesauro's Opinion of 19 April 1989 (point 3, at p. 1403).

(4) OJ, English Special Edition 1965-1966, p. 20.

(5) [1983] ECR 3883.

(6) [1981] ECR 895.