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Opinion of Mr Advocate General Van Gerven delivered on 15 October 1992. - Abbott GmbH v Oberfinanzdirektion Köln. - Reference for a preliminary ruling: Bundesfinanzhof - Germany. - Common Customs Tariff - Monoclonal antibodies. - Case C-191/91.



European Court reports 1993 Page I-00867



Opinion of the Advocate-General



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Mr President,

Members of the Court,

1. In this case, the Bundesfinanzhof ("the national court") has referred to the Court for a preliminary ruling a number of questions relating to the interpretation of heading 3002 of the Common Customs Tariff ("the CCT") and the subheadings thereof, as set out in the Report of the Judge-Rapporteur, with a view to the classification of monoclonal antibodies.

As we know, the CCT Combined Nomenclature was laid down by Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff. (1) The questions arise in the context of a dispute between the company Abbott GmbH and the Oberfinanzdirektion Koeln.

2. Abbott is part of the Abbott group, a leading group in the pharmaceutical industry. Amongst other things, it markets sets of goods known as "test-kits". They are kits, packaged for retail sale, containing various laboratory reagents for use as immunoassay tests for diagnostic purposes, namely detecting and identifying certain substances in human serum and plasma.

In late May and early June 1989, the Oberfinanzdirektion issued binding tariff classification notices relating to four of Abbott' s kits. On the basis both of the monoclonal diagnostic reagent or antibody which determined their nature and of their composition, those four kits were classified by the Oberfinanzdirektion under subheading 3002 90 90, "other" products, of the Combined Nomenclature. Abbott challenged that classification, relying, inter alia, on a non-binding tariff notice issued to it by the United Kingdom customs authorities for one of those kits, referring to subheading 3002 90 30, "animal blood prepared for ... diagnostic uses."

Abbott' s objection was, however, dismissed. It then appealed to the national court, seeking the annulment of the said binding tariff classification notices and the classification of the kits under subheading 3002 10 10, "antisera."

3. The national court asks the Court, in substance, if the CCT Combined Nomenclature is to be interpreted as meaning that the kits in question are to be classified, pursuant to general rule 3(b) of the CCT, as "other" products within the meaning of subheading 3002 90 90 or rather as antisera under subheading 3002 10 10 or, if neither of those is correct, under which other subheading of heading 3002 or of another heading of the CCT (such as heading 3822) those kits should properly be classified.

4. Written observations have been submitted by Abbott and by the Commission and are set out in the Report of the Judge-Rapporteur. In its observations, the Commission proposed that the kits in question should be included under subheading 3002 10 91. By letter of 21 February 1992, Abbott intimated that it had reconsidered its position in the meantime and now agreed with the Commission' s point of view. It admits that it had not taken sufficient account of the importance of the material nature of sera for the classification of antibodies and that it therefore no longer maintains its proposed classification under tariff heading 3002 10 10.

5. I, too, am convinced by the Commission' s views, in which I find the following points of importance.

In the first place, as the national court points out in its order for reference, the general rules for the interpretation of the Combined Nomenclature must be applied. The kits in question are made up of different substances capable of classification under at least two CCT headings. There is no heading with a more specific description which, under general rule A.3(a), should be preferred over headings of more general scope. Consequently, we should apply general rule A.3(b) which specifies, inter alia, that "goods put up in sets for retail sale" are to "be classified as if they consisted of the material or component which gives them their essential character in so far as this criterion is applicable."

6. I consider it self-evident that the kits are to be regarded as goods put up in sets for retail sale. (2) It is therefore a matter of identifying the material which gives the kits their essential character. The national court, the parties to the main proceedings and the Commission all agree that the monoclonal antibodies are what gives that character. Those antibodies are produced in the blood by B-lymphocytes (also known as blood-lymphocytes, a type of white blood corpuscles) which are themselves components of blood (or "blood fractions", to use the terminology of the CCT); such monoclonal antibodies are thus also blood fractions and are referred to as immunoglobulins. The monoclonal antibodies produced in a laboratory with a view to making up the kits with which this case is concerned are obtained by separation from a hybridoma (resulting from the fusion of a B-lymphocyte and a cancer cell). Since such antibodies are the same as those given off by B-lymphocytes in the blood, those monoclonal antibodies are also immunoglobulins.

Since the essential component of the kits is immunoglobulin and immunoglobulin is regarded, according to the Explanatory Notes to the nomenclature issued by the Customs Cooperation Council, (3) as a blood fraction, (4) it is right to classify the kits under subheading 3002 10, "antisera and other blood fractions." It is thus unnecessary to resort, as the Oberfinanzdirektion did, to subheading 3002 90 90, "other" products.

7. The precise classification of the kits under one of the subheadings of 3002 10 remains to be determined. First, it is necessary to choose between "antisera" and "other blood fractions", the latter being further subdivided into the various categories cited in the next paragraph. Sera are obviously out of the question: according to the Customs Co-operation Council' s Explanatory Note for heading 3002, section C, second paragraph, sera are the fluid fractions separated from blood after clotting, and that is not the case for monoclonal antibodies. The kits must consequently be classified as "other blood fractions."

Finally, among those "other blood fractions," a choice must be made between "haemoglobin, blood globulins and serum globulins" (3002 10 91), "other" fractions "of human origin" (3002 10 95) and "other" "other" fractions (3002 10 99). For the Commission it is clear, and Abbott does not contest, that immunoglobulins are blood globulins or serum globulins within the meaning of subheading 3002 10 91 (the choice between those two descriptions ° blood globulin or serum globulin ° is irrelevant here since both come under the same tariff heading). I see no reason not to agree.

8. I therefore propose that the Court give the following answer to the questions submitted by the national court:

The Common Customs Tariff combined nomenclature is to be interpreted as meaning that goods put up in sets ("test-kits") having a monoclonal diagnostic reagent or antibody as their principal component are to be classified under subheading 3002 10 91 ("other blood fractions ... haemoglobin, blood globulins and serum globulins").

(*) Original language: Dutch.

(1) ° OJ 1987 L 256, p. 1. Numerous amendments have been made to it since then, but none are relevant to the present case.

(2) ° For further consideration of what is to be understood by goods put up in sets within the meaning of general rule A.3, see Case 163/84 Hauptzollamt Hannover v Telefunken [1985] ECR 3299, paragraph 35.

(3) ° The Court has consistently held that those notes constitute a valuable aid in the interpretation of the CCT. Among other recent judgments, see Case 245/87 Blaupunkt-Werke v Oberfinanzdirektion Berlin [1989] ECR 573 (summary publication), Case 164/88 Ministère Public v Rispal and Others [1989] ECR 2041 (summary publication) and Case C-265/89 Vismans Nederland v Inspecteur der Invoerrechten en Accijnzen [1990] ECR I-3411, paragraph 18.

(4) ° See the Explanatory Note for heading 3002, section C. That note is cited in full in the Report of the Judge-Rapporteur.