C-259/00
ECLI:EU:C:2001:503
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O P I N I O N OF ADVOCATE GENERAL STIX-HACKL delivered on 2 October 2001 1
I — Introductory remarks tariff and statistical nomenclature and on the Common Customs Tariff. 3The version applying to the period at issue in this case is established in Commission Regulation (EC) No 2086/97 of 4 November 1997 amend- 1. This case concerns the classification for ing Annex I to Council Regulation (EEC) customs tariff purposes of immunoglobulin No 2658/87. 4 concentrates from dried, defatted and deca- seinated colostrum. The referring court seeks to ascertain whether such products are regarded as pharmaceutical products within the meaning of the Common Cus- toms Tariff.
3. Extracts from Annex I to the CN in the version relevant to the main proceedings read as follows:
I I — Legal framework
2. In the Community, goods are subject to classification for customs tariff and statis- tical purposes on the basis of the Combined 'CHAPTER 4 Nomenclature (hereinafter 'CN') which is based on the international Harmonised System 2(hereinafter 'HS'). The CN is set out in Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the
1 — Original language: German. 2 — Harmonised Commodity Description and Coding System established on the basis of the International Convention of DAIRY PRODUCE; BIRDS' EGGS;... 14 June 1983 which was approved by the Community by Council Decision 87/369/EEC of 7 April 1987 concerning the conclusion of the International Convention on the Harmonised Commodity Description and Coding System 3 — OJ 1987 L 256, p. 1. and of the Protocol of Amendment thereto (OJ 1987 L 198, p. 1). 4 — OJ 1997 L 312, p. 1.
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Notes CHAPTER 35
4. This chapter does not cover: ALBUMINOIDAL SUBSTANCES;... (b) ... globulins (heading No 3504).
3504 00 00 Peptones and their derivatives; 0404 Whey,... products consisting of other protein substances and natural milk constituents,... their derivatives, not elsewhere specified or included;... 0408 Birds' eggs... and egg yolks,... — Egg yolks: 0408 11 Dried: 0408 11 20 Unfit for human con- sumption ...'.
CHAPTER 30 4. Extracts from the Explanatory Notes on the Harmonised Commodity Description and Coding System published by the Cus- toms Cooperation Council (hereinafter 'Ex- planatory Notes on the HS') read: PHARMACEUTICAL PRODUCTS
'04.04 — WHEY,...
3001 Glands...
3004 Medicaments...
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The heading does not cover: (f) Globulins and globulin fractions (other than those of blood or serum) not prepared for therapeutic or prophylac- tic use (heading 35.04).
(e) ... globulins (heading 35.04).
I I I— Facts and main proceedings
5. According to the referring court, the 30.01 — ... EXTRACTS OF GLANDS... plaintiff in the main proceedings, Biochem OR OF THEIR SECRETIONS FOR Zusatzstoffe Handels- und Produktions ORGANO-THERAPEUTIC USES;... GmbH (hereinafter 'Biochem'), applied to the Oberfinanzdirection Köln (Regional Finance Office, Cologne) for the issue of two binding tariff informations. Biochem was seeking classification of products con- sisting in a white powder, standardised by means of lactose, containing 15% or 30% of immunoglobulin concentrate, based on dried, defatted and decaseinated colostrum. It was seeking classification of the products as gland secretions for organo-therapeutic uses in heading No 3001 CN.
The heading excludes: 6. The Oberfinanzdirektion Köln passed the applications to the Oberfinanzdirektion Nürnberg (the defendant in the main pro- ceedings, hereinafter 'the OFD') which is responsible under German law for products consisting of natural milk constituents. The OFD notified Biochem by the binding tariff
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informations of 31 July 1998 that it clas- through the mother's milk or to replace the sified the goods as modified whey in mother cow. The products are used only on powder form, not containing added sugar the first day of the new-born animal's or other sweetening matter, of a protein life.... The product is used both for thera- content exceeding 15% in subheading 0404 peutic and prophylactic purposes. As the 10 14 CN or 0404 10 12 CN respectively. animals would die without direct treatment Biochem brought an action before the with this product, there is a medical referring court against the decision of indication for direct treatment of a par- 26 January 1999 rejecting its objection. ticular illness.'
7. In the proceedings before the national 8. Biochem argued that although the prod- court, Biochem essentially relied on the use ucts were based on a form of whey (colos- and effect of the products which it trum), the decisive factor for classifying the described, according to the referring court, products was, however, the immunoglobu- as follows: lin content in a concentration of 15% or 30%. As a result, there was no question of classification in heading No 0404 CN. The products were, on the contrary, to be classified as secretions from glands for organo-therapeutic uses in heading No 3001 CN.
'Immunoglobulins are antibodies which serve 5the passive immunisation of new- born calves. Although the necessary dose of immunoglobulin is present in the mother's colostrum on the birth of a calf, new-born calves would inevitably die if they did not receive this colostrum with a corresponding 9. As grounds for rejecting the plaintiff's proportion of immunoglobulins. The legal view, the OFD submitted that the lack immunoglobulins in the colostrum create of immune defence in new-born calves was local immunisation protection in the ali- natural and therefore did not constitute an mentary tract and thus prevent digestive illness. The products therefore were not problems. The purpose of using the present pharmaceutical products within the mean- products made from colostrum with an ing of Chapter 30 CN; regarded as milk, addition of immunoglobulins is, for they were covered by Chapter 4 CN. example, to stop chains of infection Although milk was formed by the animal milk gland, it was, for customs tariff purposes, more specifically covered by 5 — Footnote only relevant in the German version. Chapter 4 CN.
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10. The order for reference made by the Arguments of the parties national court on 19 April 2000 contains the following question for a preliminary ruling:
12. Biochem and the Commission take the view that the immunoglobulin concentrates are pharmaceutical products within the meaning of Chapter 30 CN. They essen- 'Is the combined nomenclature in the tially take the purpose of the products as version of Annex I to Regulation (EC) the basis for that argument. That purpose is No 2086/97 (OJ 1997 L 312) of 4 Novem- solely to provide prophylactic immuni- ber 1997 amending Annex I to Council sation for new-born calves and, in certain Regulation (EEC) No 2658/87 on the tariff cases, immunisation which serves to pre- and statistical nomenclature and on the vent the spread of infection from the Common Customs Tariff to be interpreted mother cow to the new-born calf. In their as meaning that immunoglobulin concen- view, the immunoglobulins in addition trates from dried, defatted and decasei- created local immunisation protection in nated colostrum, standardised by means of the alimentary tract and thus prevented lactose, are to be classified as pharmaceuti- digestive problems. The immunising effect cal products in Chapter 30?' was apparent from the particularly high percentage content of immunoglobulin. The fact that colostrum present in cows formed the basis for preparing the immu- noglobulins in the concentrates was of secondary importance as regards tariff classification, as was the fact that lactose was used as a water-soluble vehicle to standardise the products. The nutritional value of the immunoglobulin concentrates IV — The question referred for a prelimi- for new-born calves was so low in fact that nary ruling the immunoglobulin concentrates could not be used for nutritional purposes.
11. These proceedings relate to the classifi- cation for customs tariff purposes of two products involving the same substance and distinguished only by their respective 13. In support of its argument, Biochem immunoglobulin content (15% or 30%). relies on Explanatory Note (f) 6 on heading Since the percentage proportion is irrel- 30.01 HS. According to that note, globulins evant to the question whether they are covered for customs tariff purposes by Chapter 30 CN or Chapter 4 CN, the term 6 — Reference was made in the written observations to 'Ex- 'immunoglobulin concentrates' is used planatory Note 17.0 on heading 3001 HS'. However, the text cited is clearly set out in Explanatory Note (f) on hereinafter to refer to the two products. heading 30.01 HS.
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not prepared for therapeutic or prophylac- 15. The Commission also considers that tic use are excluded from heading 30.01 the immunoglobulin concentrates cannot HS, and thus conversely it must be assumed be classified in heading No 0404 CN (whey that globulins such as the immunoglobulin or products consisting of natural milk concentrates at issue which indeed are used constituents). It has submitted that colos- for prophylactic or therapeutic purposes trum present in cows, which forms the are to be classified in heading No 3001 CN. basis of the immunoglobulins, is neither whey in the strict sense nor milk. By virtue of its particularly high concentration of immunoglobulins and its very low nutri- tional content, colostrum is not a food; it is an immunisation preparation.
16. The OFD maintains the view it put 14. The Commission first makes a general forward in the proceedings before the reference to the General Rules for the national court, that the immunoglobulin Interpretation of the Combined Nomencla- concentrates should be classified for cus- ture and to the settled case-law of the Court toms tariff purposes as modified whey. It that classification for customs purposes considers that the immunoglobulin concen- within the Combined Nomenclature must trates should be classified in heading in general be effected on the basis of their No 0404 CN because they constitute objective characteristics and properties and modified whey in powder form which is the Explanatory Notes on the HS constitute covered word for word by subheading an important aid. 7 Furthermore, it 0404 10 CN (whey and modified whey). explicitly relies on the settled case-law of Thus, classification in a different chapter of the Court concerning the distinction made the CN was impossible. Even the condition between pharmaceutical products in head- 'not elsewhere specified or included' con- ing No 3004 CN (medicaments) and head- tained in heading No 0404 CN was imma- ings other than those included in Chapter terial in that regard because it referred to 30 CN. The Court's distinction turned on the second part of heading No 0404 CN whether products have clearly defined (products consisting of natural milk con- therapeutic or prophylactic characteristics, stituents) rather than to the first part the effect of which is concentrated on (whey). precise functions of the organism. 8 The immunoglobulin concentrates at issue were prepared for such therapeutic and prophy- lactic uses since they serve to prevent diseases occurring where there is a lack of immune defence or are administered to treat diseases which have already occurred. Assessment
7 — Case C-201/96 LTM v FIRS [1997] ECR I-6147. 8 — Case C-177/91 Bioforce v Oberßnanzdireklion München 17. The parties in the main proceedings [19931 ECR I-45; LTM, cited in footnote 7; Case C-270/96 Sarget v FIRS [1998] ECR I-1121. essentially disagree on whether the prod- I - 2468
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ucts at issue in this case can be classified in account in accordance with the case-law of one of the headings of Chapter 4 CN (as the Court. 11 dairy produce) or in one of the headings of Chapter 30 CN (as secretions from glands for organo-therapeutic uses).
— Classification in Chapter 4 CN
18. The Court has consistently held that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods for customs pur- poses is in general to be sought in their objective characteristics and properties as defined in the wording of the relevant heading of the CN. 9The corresponding 20. On the basis of Biochem's undisputed explanatory notes drawn up by the Cus- description of the immunoglobulin concen- toms Cooperation Council as regards the trates, there are criteria to support and Harmonised Commodity Description and reject classification by reason of wording in Coding System may be an important aid to heading No 0404 CN (whey...; products the interpretation of the scope of the consisting of natural milk constituents,...): various tariff headings but do not have legally binding force. 10
First, the fact that lactose is used as a water-soluble vehicle to improve the 19. Therefore, the wording of the relevant administrability of the concentrated immu- tariff headings will be examined first below noglobulins points to classification in that in connection with the relevant notes on the heading. However, according to the case- CN and the relevant explanatory notes on law of the Court, 12 such vehicles in them- the HS. If, on such examination, it is found selves are irrelevant as regards tariff clas- that classification is possible in several sification of the product as a whole, and headings, other criteria must be taken into therefore the sole fact that lactose is used cannot in this instance result in classifi- cation in Chapter 4 CN. 9 — Case C-459/93 Thyssen Haniel Logistic [1995] ECR I-1381 and Joined Cases C-106/94 and C-139/94 Colin and Dupré 11995] ECR I-4759. 10 — Case C-35/93 Develop Dr. Eisbein v Hauptzottamt Stutt- gart-West (1994] ECR I-2655 and Colin and Dupré, cited 11 — See point 35. in footnote 9. 12 — See Bioforce, cited in footnote 8.
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2 1 . Furthermore, colostrum present in yolks, dried), heading No 0408 CN (Birds' cows is the basis for the immunoglobulin eggs, not in shell, and egg yolks,...) contains which characterises the immunoglobulin a further subsection for products which are concentrates. In its natural form, colostrum described as being 'unfit for human con- is the first 'mother's milk' that new-born sumption' (e.g. 0408 11 20 CN). calves usually receive from the mother cow.
24. For the time being, it can therefore be 22. However, doubts could arise as to stated for the record that the immunoglo- whether immunoglobulin concentrates can bulin concentrates could in principle be be classified as 'milk' or 'whey' in a heading covered by the wording of heading No 0404 of Chapter 4 CN because the colostrum CN by reason of the fact that they essen- used in the preparation of immunoglobulin tially consist of immunoglobulins from the concentrates cannot in this case be used for colostrum of dairy cows (first 'mother's nutritional purposes, as 'milk' or 'whey' milk' for new-born calves). usually can. On the contrary, colostrum is a substance which in itself predominantly consists of immunoglobulins and contains only a very small proportion of nutritional components. If the colostrum is then deca- seinated and defatted, as it is in this case, the nutritional function becomes entirely insignificant.
— Classification in Chapter 30 CN
23. In that respect, however, it remains unclear whether classification in the vari- ous headings of Chapter 4 CN may in any 25. On the basis of Biochem's undisputed case depend on whether the products con- description of the immunoglobulin concen- cerned serve to feed living beings or are at trates, there are also criteria to support and least suitable for consumption. The pre- reject classification by reason of wording in dominant argument against that consider- heading No 3001 CN (extracts of glands... ation is that, in all its subheadings, for or of their secretions for organo-thera- instance in subheading 0408 11 CN (Egg peutic uses...).
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26. Colostrum present in cows is without a in calves, which indicates that there must doubt a secretion produced from glands. Its be a further prophylactic use which is not purpose is organo-therapeutic since it aimed (only) at making up for an innate serves the passive immunisation of new- deficiency. born calves which do not have their own adequate, natural store of immunisation protection directly after their birth. Immu- noglobulin concentrates are administered on the first day of the new-born animal's life as a preventive measure in case colos- trum, the natural substance which contains 28. Consequently, it can be stated first of immunoglobulin and compensates for such all that the immunoglobulin concentrates immunodeficiency, should not be available could be covered by the wording of heading from the mother cow or in case infection No 3001 CN. should have to be prevented from spreading from the mother cow to the calf. Moreover, the immunoglobulins create local immuni- sation protection in the alimentary tract and generally prevent digestive problems in calves. 29. However, a different conclusion could be reached following consideration of the Notes on the CN and the Explanatory Notes on the HS.
30. According to Note 4(b) on Chapter 4 CN and Note (e) on heading 04.04 in the Explanatory Notes on the HS, globulins are to be classified in heading No 3504 CN. 27. The OFD's counter-argument, that Taken in isolation, those notes would there could be no question of therapeutic appear to suggest that all globulins, includ- or prophylactic use because the lack of ing immunoglobulins and by extension the personal passive immunisation in new-born immunoglobulin concentrates in question, calves was natural and therefore was not an are covered by heading No 3504 CN. This illness, is in that respect unconvincing. would, however, preclude classification for Therapeutic or prophylactic effects by all customs tariff purposes in one of the head- means may be indicated even where there ings of Chapter 30 CN. are innate deficiencies. The only relevant point is that failure to remedy the defi- ciency leads to physical problems or, as in this case, even to the animal's certain death. By creating local immunisation protection in the alimentary tract, the immunoglobu- lin concentrates ultimately provide preven- 31. Note (f) on heading 30.01 in the tive protection against digestive problems Explanatory Notes on the HS on the other
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hand points to classification in Chapter 30 consist of immunoglobulins from the colos- of the CN, in heading No 3001 CN to be trum of dairy cows. more precise. The wording of that note is more restrictive than that of Note 4(b) on Chapter 4 CN as regards the tariff classifi- cation of globulins. Note (f) on heading 30.01 in the Explanatory Notes on the HS states that only globulins other than those of blood or serum which are not prepared for therapeutic or prophylactic use are to — Distinction between Chapter 4 CN and be covered by heading 35.04 HS. Chapter 30 CN
34. If it is consequently to be established 32. The characteristic substance of the that the immunoglobulin concentrates at immunoglobulin concentrates at issue in issue could, by virtue of their objective this case indeed is obtained from the colos- characteristics and properties, be covered trum of dairy cows, not therefore from (in both by the wording of a heading in this case, animal) blood or serum, 13 and Chapter 4 CN and by the wording of a thus the first criterion appears to be heading in Chapter 30 CN, criteria other fulfilled. However, the immunoglobulin than those involving the wording of the concentrates are, as stated above, prepared relevant headings and involving the inter- for prophylactic or therapeutic use, and pretation of the Explanatory Notes on the thus the second criterion for classification HS must be taken into account for the in heading 35.04 HS is not fulfilled. purpose of tariff classification.
35. The Court already had to address the 33. Consequently, it can be stated that the issue of product classification for customs immunoglobulin concentrates could in tariff purposes in previous judgments principle be covered by the wording of where, for instance, it was unclear whether Chapter 30 CN because they essentially the products should be classified as medic- aments in heading No 3004 CN or else in other headings not included in Chapter 30 13 — If they [the immunoglobulins] had been obtained from CN. In that regard, it essentially took the animal blood or serum, they would definitely be classified question whether the product concerned in subheading 3002 10 91 CN (blood globulins); compare with the classification of monoclonal antibodies for customs tariff purposes in Case C-191/91 Abbott v has a clearly defined therapeutic or pro- Oberfinanzdirektion Köln [1993) ECR I-867. phylactic characteristic, the effect of which
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is concentrated on precise functions of the factor where it constitutes the main use of organism, 14 to be the basic criterion for the product and it is focused against a classification in heading No 3004 CN particular illness or a particular organic (medicaments...). disease or a particular deficiency.
36. Although within Chapter 30 CN immunoglobulin concentrates cannot be regarded as medicaments within the mean- ing of heading No 3004 CN on account of the precise description of origin contained 38. Such are the circumstances in this case. in heading No 3001 CN (secretion from Colostrum present in cows or at least the glands), the criteria developed in the case- essential component of colostrum (immu- law mentioned in the preceding paragraph noglobulin) is a characteristic feature of the for distinguishing between medicaments immunoglobulin concentrates at issue. and other headings not included in Chapter Immunoglobulin has a prophylactic and, 30 CN can still be applied in a more general where necessary, therapeutic effect as manner. regards the passive immunisation of new- born calves. The effect is focused on prevention or treatment of a particular illness (new-born calves not yet having adequate immunisation protection of their own).
37. All of the headings in Chapter 30 CN are, after all, distinguished from the head- ings in other chapters of the CN, including from the headings in Chapter 4 CN, by the fact that they serve a specific purpose. If and in so far as it is possible to classify goods for customs tariff purposes in accordance with the wording of the rel- evant headings both in a heading which covers products not having a clearly spec- 39. The immunoglobulin concentrates at ified use and in a heading of Chapter 30 issue thus fulfil the essential criteria which CN, that is to say where there is a specified the Court laid down in the abovementioned (in this case, therapeutic or prophylactic) case-law 15 in respect of classification for use, then, in cases of doubt, the therapeutic customs tariff purposes in one of the head- or prophylactic effect must be the decisive ings of Chapter 30 CN (pharmaceutical products). 14 — Bioforce, cited in footnote 8; VTM, cited in footnote 7; Case C-328/97 Glob-Sped AG v Hauptzolbmt Lörrach [1998] ECR I-8357. 15 — Cited in footnote 14.
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V — Conclusion
40. In the light of the foregoing considerations, I therefore propose that the Court answer the question referred by the national court as follows:
The combined nomenclature in the version of Regulation (EC) No 2086/97 (OJ 1997 L 312) of 4 November 1997 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff is to be interpreted as meaning that immunoglobulin concentrates from dried, defatted and decaseinated colostrum, standardised by means of lactose, are to be classified as pharmaceutical products in Chapter 30.
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