Opinion of Mr Advocate General

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.

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.

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 30029090 or rather as antisera under subheading 30021010 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 30021091. 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.

6. I consider it self-evident that the kits are to be regarded as goods put up in sets for retail sale. 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 bloodlymphocytes, 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.

7. The precise classification of the kits under one of the subheadings of 300210 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 Cooperation 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.

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

1 Original language: Dutch.

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

3 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.

4 The Court has consistently held that those notes constitute a valuable aid in the interpretation of the OCT. 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.

5 See the Explanatory Note for heading 3002, section C.That note is cited in full in the Report of die Judge-Rapporteur.