61993J0459

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Common Customs Tariff ° Tariff headings ° Mixture of amino acids used for the preparation of infusion solutions ° Product naturally intended for medical use ° Classification under heading 30.03 (subheading 30.03 A II (b))

The Common Customs Tariff, as amended by Regulation No 3618/86, amending Regulation No 3331/85 amending Regulation No 950/68, must be interpreted to the effect that a sterile powder made up of amino acids mixed in precise proportions and used for the preparation of infusion solutions falls under heading 30.03 (subheading 30.03 A II (b)). On the basis of its objective characteristics and properties ° being sterile, pyrogen-free, with a high level of purity and precise dosage of the various amino acids ° the product is naturally intended for medical use and more particularly for the preparation of infusion solutions by the addition of water, and use of the product in question in human nutrition by way of mouth is a purely theoretical possibility. In view of that intended use and in the light of Note A(4) of the Customs Cooperation Council' s Explanatory Notes to Heading 30.03, it therefore falls within the category of medicaments.

In Case C-459/93,

REFERENCE to the Court under Article 177 of the EEC Treaty by the Bundesfinanzhof for a preliminary ruling in the proceedings pending before that court between

Hauptzollamt Hamburg-St Annen

and

Thyssen Haniel Logistic GmbH

on the interpretation of tariff headings 21.07 and 30.03 of the Common Customs Tariff as amended by Council Regulation (EEC) No 3618/86 of 24 November 1986, amending Regulation (EEC) No 3331/85 amending Regulation (EEC) No 950/68 on the Common Customs Tariff (OJ 1986 L 345, p. 1),

THE COURT (Third Chamber),

composed of: C. Gulmann (Rapporteur), President of the Chamber, J.C. Moitinho de Almeida and J.-P. Puissochet, Judges,

Advocate General: G. Cosmas,

Registrar: H. von Holstein, Deputy Registrar,

after considering the written observations submitted on behalf of:

° Hauptzollamt Hamburg-St Annen, by T. Guessefeldt, Oberregierungsrat at the Oberfinanzdirektion Hamburg,

° Thyssen Haniel Logistic GmbH, by E.A. Undritz, Rechtsanwalt, Hamburg,

° the Commission, by F. de Sousa Fialho, of its Legal Service, acting as Agent, assisted by H.-J. Rabe, Rechtsanwalt, Hamburg, and a member of the Brussels Bar,

having regard to the Report for the Hearing,

after hearing the oral observations of Thyssen Haniel Logistic GmbH and the Commission at the hearing on 19 January 1995,

after hearing the Opinion of the Advocate General at the sitting on 23 March 1995,

gives the following

Judgment

1 By order of 19 October 1993, which was received at the Court on 8 December 1993, the Bundesfinanzhof (Federal Finance Court) referred to the Court for a preliminary ruling under Article 177 of the EEC Treaty two questions on the interpretation of tariff headings 21.07 and 30.03 of the Common Customs Tariff ("CCT") as amended by Council Regulation (EEC) No 3618/86 of 24 November 1986, amending Regulation (EEC) No 3331/85 amending Regulation (EEC) No 950/68 on the Common Customs Tariff (OJ 1986 L 345, p. 1).

2 The questions were raised in proceedings between Hauptzollamt (Principal Customs Office) Hamburg-St Annen and Thyssen Haniel Logistic GmbH (hereinafter "Thyssen") in connection with the classification for customs purposes of goods described as "Amino Acid AA Mixture Peco" presented as powdered sterile mixtures of various amino acids in measured doses for the manufacture of infusion solutions.

3 In March 1987 Thyssen declared such goods as other medicaments not put up in forms or in packings of a kind sold by retail falling under subheading 30.03 A II (b) of the CCT. The Hauptzollamt, however, taxed the goods as "other food preparations" under heading 21.07 and accordingly imposed revised customs duties.

4 Thyssen brought an action against that decision in the Finanzgericht (Finance Court) Hamburg. That court upheld Thyssen' s claim that the goods fell under subheading 30.03 A II (b) of the CCT.

5 The Hauptzollamt appealed to the Bundesfinanzhof. It contended that at the material time there was as yet no finished product for artificial parenteral nutrition. Furthermore, inasmuch as further processing was possible, the products could not be regarded as non-finished infusion solutions. The nature of the goods in question indicated that they were food preparations which could solely be administered orally.

6 The Bundesfinanzhof considered that an interpretation of the CCT was required before the case could be resolved and decided to stay the proceedings and refer the following questions to the Court for a preliminary ruling:

"1. Is the Common Customs Tariff to be interpreted to the effect that products such as powdered sterile mixtures of various amino acids in measured doses for the manufacture of infusion solutions fall as 'medicaments' under tariff heading 30.03 (in this case tariff subheading 30.03 A II (b))?

2. If not:

Is the Common Customs Tariff (1987) to be interpreted to the effect that goods such as those described in question 1 fall as 'other food preparations' under tariff heading 21.07?"

7 The relevant subheadings of the CCT in force at the material time are worded as follows:

° Heading 21.07:

"Food preparations not elsewhere specified or included:

A. Cereals in grain or ear form, pre-cooked or otherwise prepared:

[...]

G. Other:

[...]"

° Heading 30.03:

"Medicaments (including veterinary medicaments):

A. Not put up in forms or in packings of a kind sold by retail:

I. Containing iodine or iodine compounds

II. Other:

(a) Containing penicillin, streptomycin or their derivatives

[...]

(b) Other

B. Put up in forms or in packings of a kind sold by retail:

[...]"

8 It is settled case-law that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods for customs purposes is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the Common Customs Tariff and of the notes to the sections or chapters (see, in particular, the judgment in Case C-395/93 Neckermann Versand [1994] ECR I-4027, at paragraph 5). Likewise, for the purpose of interpreting the Common Customs Tariff, the Court has consistently held that both the notes which head the chapters of the Common Customs Tariff and the Explanatory Notes to the Nomenclature of the Customs Cooperation Council are important means for ensuring the uniform application of the Tariff and as such may be regarded as useful aids to its interpretation (same judgment, at paragraph 5).

9 According to Note 1(a) to Chapter 30 of the Common Customs Tariff, for the purposes of heading 30.03, "medicaments" means products which have been mixed or compounded together for therapeutic or prophylactic uses.

10 The same note specifies that that definition does not apply to foods or beverages such as dietetic, diabetic or fortified foods, tonic beverages and spa water. However, according to Note A(4) of the Explanatory Notes to the Customs Cooperation Council Nomenclature concerning heading 30.03 "Nutritional preparations for ingestion other than by mouth" are covered by "medicaments". That can be explained by the fact that that type of nutritional preparation is always used as part of medical treatment.

11 Amino acids, as basic constituents of proteins, may be regarded as nutritional substances. According to the Customs Cooperation Council' s Explanatory Notes to heading 30.03, proteins are among the major nutritional substances in food.

12 Since that is the case, the question whether the mixture of amino acids at issue is a nutritional preparation for ingestion other than by mouth must be examined.

13 In this connection it should be noted that the intended use of a product may constitute an objective criterion for classification if it is inherent to the product, and that inherent character must be capable of being assessed on the basis of the product' s objective characteristics and properties (see the judgment in Case 36/71 Henck [1972] ECR 187, at paragraph 4).

14 Accordingly, if the intended use of the mixture inherent to its particular characteristics meant that it would be used for the preparation of infusion solutions for artificial parenteral nutrition, the product would have to be regarded as falling under heading 30.03.

15 It is clear from the documents in the case that "Amino Acid AA Mixture Peco" is presented in the form of a sterile, pyrogen-free powder of several amino acids in measured doses. The term "doses" as used by the Bundesfinanzhof does not have the same connotation as it does in the Common Customs Tariff and the Explanatory Notes to the Nomenclature of the Customs Cooperation Council. According to Note (B)(a) thereof, products are put up in the form of "doses" where the unmixed product is presented in the measured quantitities in which they are to be used for therapeutic or prophylactic use, generally in forms such as tablets, ampoules, capsules, cachets, or small quantities of powder ready for taking as single doses. The Bundesfinanzhof intended solely to indicated that the amino acids making up the mixture are presented in precise proportions.

16 As was made clear at the hearing before the Court and in the expert opinion produced by Thyssen before the national courts, to which both Thyssen and the Commission referred in their written observations and which was not contested by the Hauptzollamt, use of the amino acid mixtures in question as a foodstuff is theoretically conceivable but highly improbable from an economic point of view, because the product' s high level of microbiological and chemical purity obtained at great expense, as well as the fact that it is pyrogen-free, de facto preclude its use in that area, where recourse may be had to many other options which are much cheaper.

17 Since the use of the product in question in human nutrition by way of mouth is a purely theoretical possibility it would therefore appear that, on the basis of its objective characteristics and properties ° being sterile, pyrogen-free, with a high level of purity and precise dosage of the various amino acids ° the said product is naturally intended for medical use and more particularly for the preparation of infusion solutions by the addition of water.

18 Consequently the reply to the national court must be that the CCT, as amended by Regulation No 3618/86, must be interpreted to the effect that a sterile powder made up of amino acids mixed in precise proportions and used for the preparation of infusion solutions falls under heading 30.03 (subheading 30.03 A II (b)).

Costs

19 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 action pending before the national court, the decision on costs is a matter for that court.

On those grounds,

THE COURT (Third Chamber),

in answer to the questions referred to it by the Bundesfinanzhof by order of 19 October 1993, hereby rules:

The Common Customs Tariff as amended by Council Regulation (EEC) No 3618/86 of 24 November 1986, amending Regulation (EEC) No 3331/85 amending Regulation (EEC) No 950/68 on the Common Customs Tariff, must be interpreted to the effect that a sterile powder made up of amino acids mixed in precise proportions and used for the preparation of infusion solutions falls under heading 30.03 (subheading 30.03 A II (b)).