1 By order of 12 June 1991, received at the Court on 26 July 1991, the Bundesfinanzhof (Federal Finance Court) referred to the Court for a preliminary ruling under Article 177 of the EEC Treaty a number of questions on the interpretation of the Common Customs Tariff, introduced by Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ 1987 L 256, p. 1), with a view to the classification of certain goods put up in sets ("test-kits") comprising various laboratory reagents.
2 Those questions were raised in proceedings between Abbott, the plaintiff in the main proceedings, and Oberfinanzdirektion Koeln (Principal Revenue Office, Cologne), the defendant in the main proceedings, concerning the tariff classification of those goods.
3 It appears from the documents before the Court that the kits in question, which are packaged for retail sale, are intended for use as immunoassay tests for diagnostic purposes, that is to say for detecting and identifying certain substances in human serum and plasma.
4 Considering that the component which gives the kit its essential character, within the meaning of rule 3(b) of the general rules for the interpretation of the combined nomenclature (in Annex I to Regulation No 2658/87), is the monoclonal diagnostic reagent which it contains and having regard to the nature of that reagent, the Oberfinanzdirektion issued customs tariff notices in May and June 1989, classifying the kit under subheading 3002 90 90, "other" products, as a product similar to toxins.
5 Abbott brought proceedings to have those classification notices set aside, claiming that the goods in question should be classified under subheading 3002 10 10, "antisera."
6 The Bundesfinanzhof, hearing the case at first and last instance, considered it necessary for the Court to give a ruling on the interpretation of the tariff provisions governing the classification of the goods in question. It therefore submitted the following questions for a preliminary ruling: "(1) Is the Common Customs Tariff ° combined nomenclature ° to be interpreted as meaning that goods put up in sets (' test-kits' ) having a monoclonal diagnostic reagent ° antibody ° as their principal component, as described in the grounds of this order, are to be regarded, pursuant to general rule 3(b), as being 'similar products' within the meaning of subheading 3002 90 90? (2) If Question 1 is answered in the negative, does it appear from the interpretation of the Common Customs Tariff that the products in question are to be classified as antisera under subheading 3002 10 10? (3) If Question 2 is also answered in the negative, to which other subheading of heading 3002 or to which other heading of the Common Customs Tariff (for instance, heading 3822) are the products referred to above to be assigned?"
7 Reference is made to the Report of the Judge-Rapporteur for a fuller account of the facts of the case in the main proceedings, the procedure and the written observations submitted to the Court, which are mentioned or discussed hereinafter only in so far as is necessary for the reasoning of the Court.
8 It is common ground that the component which gives the kits their essential character is the monoclonal diagnostic reagent in question and that that reagent is a product falling under tariff heading 3002, which reads as follows: "3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products."
9 As regards the classification of the product in question under one of the subheadings of heading 3002, it should be stressed that subheading 3002 90 90, as a residual category, may be considered for application where goods cannot be included under any other subheading.
10 In that connection, it appears from the documents before the Court that the monoclonal diagnostic reagent which gives the kits their essential character is a monoclonal antibody. Monoclonal antibodies are produced by B-lymphocytes. The production of the kits with which this case is concerned, which are used in immunological tests, begins with a B-lymphocyte-type stem cell taken from the spleen plasma of an immunized donor animal, in this case a mouse.
11 That lymphocyte, which produces the desired monoclonal antibody, is then fused with a cancer cell which has the characteristic of multiplying indefinitely. The new cell derived from the fusion, a hybridoma, is then cultivated in a suitable medium for multiplication. The monoclonal antibody produced by the original lymphocyte thus multiplies thanks to the characteristic contributed by the cancer cell.
12 B-lymphocytes, also referred to as blood-lymphocytes, are blood fractions. Monoclonal antibodies, which are immunoglobulins, being secreted in the blood by B-lymphocytes, are thus also blood fractions and fall under subheading 3002 10, "antisera and other blood fractions."
13 It follows that monoclonal antibodies obtained in a laboratory by the hybridoma method with a view to making up the kits with which the main proceedings are concerned, being the same as those secreted in the blood by B-lymphocytes, are also immunoglobulins and must therefore be regarded as blood fractions within the meaning of subheading 3002 10.
14 As regards the classification of the products in question in one of the subdivisions of that subheading, it must be observed that those monoclonal antibodies are not "antisera" within the meaning of subheading 3002 10 10. They are not "fluid fractions separated from blood after clotting," in the definition given for sera in the Customs Cooperation Council' s Explanatory Notes for tariff heading 3002.
15 Consequently, the products in question are to be regarded as "other blood fractions" within the meaning of the second part of subheading 3002 10, quoted above. As regards their classification in one of the subdivisions of that category, it is indisputable that, as the Commission submits, the antibodies in question are immunoglobulins and must thus be regarded either as blood globulins or as serum globulins within the meaning of subdivision 3002 10 91, without there being any need, for the purpose of giving the national court an answer enabling it to settle the dispute in the main proceedings, to choose specifically between those two categories.
16 Accordingly, it should be stated in reply to the questions from the national court that the Common Customs Tariff is to be interpreted as meaning that sets of goods having a monoclonal diagnostic reagent (antibody) as their principal component are to be classified under subheading 3002 10 91.