C-459/93

1. In March 1987 Thyssen Haniel Logistic GmbH (hereinafter 'Thyssen') made a decla- ration in connection with the importation of certain goods from its bonded warehouse described as 'Amino Acid AA Mixture Peco' (powdered sterile mixture of various amino acids in measured doses for the manufacture '1. Is the Common Customs Tariff (1987) of infusion solutions). The goods were to be interpreted to the effect that prod- declared by Thyssen as 'medicaments not ucts such as powdered sterile mixtures put up in forms or in packings of a kind sold of various amino acids in measured by retail' falling under Code No doses for the manufacture of infusion 3003 290 90 of the German Customs Tariff solutions fall as "medicaments" under (subheading 30.03 A II (b) of the Common tariff heading 30.03 (in this case tariff Customs Tariff). * The Hauptzollamt (Princi- heading 30.03 A II (b))? pal Customs Office) Hamburg-St Annen, however, classified the goods as 'other food preparations' under heading 21.07 of the Common Customs Tariff and fixed the duty payable on the basis of that classification. The Finanzgericht Hamburg upheld Thys- sens appeal, finding that the goods in ques- tion did fall under subheading 30.03 A II (b)

* Original language: Greek. 2. If not: Is the Common Customs Tariff 1 — The heading numbers refer to the version of the Common (1987) to be interpreted to the effect Customs Tariff in force at the time of the declaration. See the that goods such as those described in Annex to Council Regulation (EEC) No 3618/86 of 24 November 1986 amending Regulation (EEC) No question 1 fall as "other food prepara- 3331/85 amending Regulation (EEC) No 950/68 on the Common Customs Tariff (OJ 1986 L 345, p. 1). tions" under tariff heading 21.07?'

II — The relevant headings of the Common packings of a kind sold by retail: I. Contain- Customs Tariff — Issues raised ing iodine or iodine compounds, II. Other: (a) Containing penicillin, streptomycin or their derivatives, 1. Containing penicillin or its derivatives, 2. Other, (b) Other'. In accordance with the Notes to Chapter 30 (point 1), for the purposes of heading 30.03, 'medicaments' applies to goods which are either '(a) products comprising two or more constituents which have been mixed or compounded together for therapeutic or 2. Chapter 21 of the Common Customs Tar- prophylactic uses; or (b) unmixed products iff is entitled 'Miscellaneous edible prepara- suitable for such uses put up in measured tions' and includes headings 21.02 ('Extracts, doses or in forms or in packings of a kind essences or concentrates, of coffee, tea or sold by retail for therapeutic or prophylactic mate and preparations with a basis of those purposes'. In the same Notes it is expressly extracts, essences or concentrates; roasted stated that heading 30.03 does not cover chicory and other roasted coffee substitutes 'foods or beverages such as dietetic, diabetic and extracts, essences and concentrates there- or fortified foods, tonic beverages, spa o f ) , 21.03 ('Mustard flour and prepared water'. mustard'), 21.04 ('Sauces; mixed condiments and mixed seasonings'), 21.05 ('Soups and broths, in liquid, solid or powder form; homogenised composite food preparations'), 21.06 ('Natural yeasts (active or inactive); prepared baking powders') and, lastly, head- ing 21.07 ('Food preparations not elsewhere specified or included'). According to the Notes to Chapter 21, the chapter does not cover inter alia 'yeast put up as a medica- ment and other products of heading No 30.03' (Note 1(d)). 4. As already stated, Thyssen described the goods in the customs declaration as a 'pow- dered sterile mixture of various amino acids in measured doses for the manufacture of infusion solutions'. It can be concluded from the terms of the order for reference and the written observations submitted by the par- ties in the course of these proceedings that the question which has arisen as regards the 3. Chapter 30 of the Common Customs Tar- tariff classification of the above product iff is entitled 'Pharmaceutical products' and turns on the point that while Thyssen con- contains inter alia heading 30.03 which con- siders the decisive criterion for that classifi- cerns, according to its wording, 'Medica- cation to be the fact that the mixture in ques- ments (including veterinary medicaments)'. tion is intended to be used in the Subheading 30.03 A covers in particular manufacture of infusion solutions used for medicaments ' N o t put up in forms or in artificial parenteral nutrition, the customs

Ill — Reply to the questions referred for a preliminary ruling

3 — See, for instance Case 40/88 Weber cited above, at para- graphs 19 and 20. 4 — See, for instance, the judgments in Case C-35/93 Develop Dr Eisbein [1994] ECR 1-2655, at paragraph 18, and Case C-248/92 Jepsen Stahl [1993] ECR 1-4721, at paragraphs 9 and 10. 5 — See the judgments in Case C-246/90 Parma [1992] ECR 5. According to the settled case-law of the 1-3467, at paragraph 20, Case C-219/89 WeserGold [1991] ECR 1-1895, at paragraph 9, Case 38/76 Industriemetall Court, 2 in the interests of legal certainty and Lama [1976] ECR 2027, at paragraph 7, and Case 38/72 Van de Poll [1972] ECR 1329, at paragraphs 4 and 5. See also the judgment cited above. Case C-395/93 Neckermann Versand, at paragraphs 7 to 9, and the judgments in Case C-108/92 Astro-Med [1993] ECR 1-3797, at paragraph 8, Case C-218/89 Shimadzu Europa [1990] ECR 1-4391, at 2 — See, amongst many others, the judgments in Case paragraph 10 et seq. and Case 114/80 Ritter [1981] ECR 895, C-395/93 Neckermann Versand [1994] ECR 1-4027, at para- at paragraphs 7 to 9. graph 5, Case C-338/90 Hamlin Electronics [1992] ECR 1-2333, at paragraph 8, Case C-120/90 Post [1991] ECR 6 — See the judgments in Case C-256/93 EmsLmd-Stärke [1993] 1-2391, at paragraph 11, Case 40/88 Weber [1989] ECR 1395, ECR 1-1857, at paragraph 16, and Case 36/71 Henck [1972] at paragraph 13, and Case 175/82 Dimer [1983] ECR 969, at ECR 187, at paragraph 4. See also the judgment in Case paragraph 10. 183/73 Osram [1974] ECR 265, at paragraph 5.

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7 — See the judgments in Case 222/85 Kleiderwerke Hela Lampe [1986] ECR 2449, at paragraph 15, and Case 90/85 Mikx [1986] E C R 1695, at paragraph 15. See also the judgment in Case C-228/89 Farfalla Flemming [1990] ECR 1-3387, at paragraphs 20 and 22. 8 — O n the significance of the notes which head the chapters of the Common Customs Tariff for the interpretation of the chapter headings see, amongst many others, the judgment in Case C-356/93 Techmeda [1994] ECR 2371, at paragraph 28, and Case C - l l / 9 3 Siemens Nixdorf [1994] ECR 1-1945, at paragraph 12. 9 — According to settled case-law (see, for exampie the judgment already cited in Case C - l l / 9 3 Siemens Nixdorf, at paragraph 12, and the judgments in Case C-14/91 SuCrest [1992] ECR 1-441, at paragraph 10, Case C-265/89, Vismans Nederland [1990] E C R 1-3411, at paragraph 18, Case 167/84 Dmnert 7. Heading 30.03 of the Common Customs [1985] E C R 2235, at paragraph 14, and Case 278/80 Chem- Tec [1982] ECR 439, at paragraph 14), the Explanatory Tariff does not include a definition of the Notes of the Customs Cooperation Council are an impor- tant means for ensuring the uniform application of the Com- term 'medicaments'. The use, however, of the mon Customs Tariff. The Court states in clarification, how- ever, that since those notes do not have legally binding force, preposition 'for' (in the Greek version) where appropriate, it is necessary to consider whether their makes obvious, I consider, the fact that the content is in accordance with the actual provisions of the C o m m o n Customs Tariff and whether they alter the mean- composition of the product is not adopted as ing of such provisions (see, in particular, the judgment in Case C-35/93 Develop Dr Eisbein, cited above, at paragraph the primary criterion for classification under 21, and the references given therein). that heading in principle (but does regain,

however, its significance for the purposes of 8. In view of the foregoing, it is not possible classification under the subheadings) but to doubt that at all events preparations rather its intended use. That is also con- which are used for curing or preventing cer- firmed in the Notes referred to above (see tain ailments should be regarded as 'medica- point 3) which head Chapter 30 of the Com- ments' within the meaning of heading mon Customs Tariff, according to which (see 30.03 of the Common Customs Tariff.

. .)') covers a preparation with unmixed products suitable for such uses which has clearly defined and above all pro- put up in measured doses or in forms or in phylactic therapeutic characteristics, the packings of a kind sold by retail for thera- effect of which is concentrated on precise peutic or prophylactic purposes. Lastly the functions of the human organism. I consider, C C C Explanatory Notes to heading 30.03, however, that preparations which, without according to which 'medicaments' covers having a therapeutic or prophylactic effect as medicinal preparations for use in the internal such on a certain ailment, are used in medical or external treatment or prevention of science to treat a specific disturbance of the human or animal ailments, are completely functioning of the organism which consti- consistent with the wording of the heading tutes either one of the symptoms of a certain in question of the Common Customs Tar- ailment, or arises as a result of the treatment iff. " followed to cure an ailment, should also be regarded as 'medicaments' falling under

p. 20). The divergence can be explained by the special pur- poses of the latter text. It has in fact been held (see inter alia the judgments in Case 227/82 Van Bennekom [1983] ECR 3883, at paragraphs 14 and 17, Case C-112/89 Upjohn [1991] ECR 1-1703, at paragraph 16, and Case C-219/91 Ter Voort [1992] ECR 1-5485, at paragraph 16) that Directive 65/65, with a view not only to the abolition of hindrances to trade in proprietary medicinal products but also to serv- ing the fundamental purpose of protecting public health, gives (in Article 1(2) first and second subparagraphs) a def- inition of 'medicinal product' that covers not only products having a genuine therapeutic or prophylactic effect but also those which are not sufficiently effective or which do not have the effect which their presentation might lead consum- ers to expect. The directive thus seeks to preserve consum- ers not only from harmful or toxic medicinal products as such but also from a variety of products used instead of the proper remedies. Conversely, heading 30.03 of the Com- mon Customs Tariff should be regarded as covering only products actually intended for therapeutic or prophylactic 11 — See the judgment in Case C-177/91 Bioforce [1993] ECR use (see, on this point, point 7 of Advocate General Gul- mann's Opinion in Case C-177/91 Bioforce [1993] ECR 1-45, in particular at paragraphs 10 and 12.

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O P I N I O N O F MR COSMAS — CASE C-459/93

a 'medicament' falling under heading disfunctions of the organism which prevent 30.03 of the Common Customs Tariff even nutrition by the normal route. though that preparation, considered from the point of view of its composition alone, is made up exclusively of food substances. That conclusion is wholly consistent with both the C C C Explanatory Notes to heading 30.03, which on the one hand state that the heading does not apply to 'food preparations containing only nutritious substances', and on the other hand state (Note A(4)) that 'nutritional preparations for ingestion other than by mouth' are included. 1 2

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the combined nomenclature (OJ 1989 L 196, p. 5), the annex to which treats various preparations in the form of tablets, including inter alia amino acids, for countering defi- ciency from food lacking in proteins as food supplements and consequendy classifies them in the corresponding posi- tions of the Combined Nomenclature). 14 — The Hauptzollamt states in its observations to the Court that, in describing the mixture in question, the Bundesfi- nanzhof uses the term 'doses' ('powdered sterile mixture of various amino acids in measured doses') which appertains solely and exclusively to medicaments, thus anticipating the reply to the questions which it referred for a preliminary

Neither the Hauptzollamt, however, in which heads Chapter 30, according to which all goods inter alia falling under Chapter 29 (under which in principle its observations to the Court, nor the docu- amino acids abo fall) are to be treated as 'unmixed prod- ucts', can be regarded only as referring to the pure products ments in the case, indicate that the mixture mentioned in Chapter 29 taken separately and to the prod- imported by Thyssen is intended in fact to ucts treated as such, in accordance with the definitions in the Notes heading that Chapter, and not to mixtures of be used directly or following processing in those products (see N o t e 1 to Chapter 29 and the heading 'General* in the C C C Note). Moreover, quite indepen- normal human nutrition or that it is intended dendy of the above, from the order for reference taken as a whole, I consider that in using the term 'doses' the Bundes- finanzhof does not mean that the mixture to be classified is presented in measured doses in the quantities in which they are subsequently to be used in the manufacture of infusion solutions, but simply that the amino acids which make up 15 — See also the C C C Explanatory Notes to heading the mixture appear in certain specific proportions (see the 21.07 (Note B (10)), according to which 'protein hydroly- Commission's comments on this point at p. 14 of the sates consisting mainly of a mixture of amino-acidi and French translation of its observations). sodium chloride, used in food preparations (e. g. for fla- vouring)' are included in the heading.

14. I propose that that question should be answered in the affirmative. I recalled at an earlier point in this Opinion (see point 5 above), that the case-law of the Court indi- cates indirectly that the intended use of goods may constitute an objective criterion for their classification for customs purposes 13. That last fact is, in my opinion, of great where it constitutes an inherent property of significance in the resolution of the questions those goods. As the abovementioned report referred by the Bundesfinanzhof, for if: (1) by the Institut Fresenius explains, in prac- the use in normal human nutrition of a mix- tice, the use in normal human nutrition of a ture with characteristics such as those of the mixture with characteristics similar to those mixture in question amounts merely to a of the mixture in question is precluded owing to its inherent properties (high level of microbiological and chemical purity, pyrogen-free). It can justifiably be con- 16 — The fact relied on by the Hauptzollamt before the Bundes- finanzhof, that in the light of its composition the mixture is cluded, I believe, that it is those specifically a preparation which can be taken by mouth does not suffice inherent properties which determine that in for classification under heading 21.07. In accordance with the foregoing account, in order for a product to fall under fact the mixture will be used exclusively for that heading it does not suffice that is made up of nutritive substances, out must further be intended in fact for normal medical purposes for the manufacture of human nutrition. From the order for reference it appears that on the question of the intended use of the mixture at infusion solutions. That position seems, issue the Hauptzollamt confined itself to alleging, without moreover, to be accepted by the Bundesfi- further elucidating the point, that 'another type of process- ing was possible'. nanzhof when, as noted above, it states that

16. For the sake of completeness, however and to further clarify the conclusion I have 15. To summarize, the questions referred to reached, the following additional points the Court by the Bundesfinanzhof should, in should be made: the Commission submits in my opinion, be answered as follows: the its observations to the Court, following an Common Customs Tariff, as amended by the analysis which is similar on many points to Annex to Council Regulation (EEC) N o my own, that the Common Customs Tariff 3618/86, should be interpreted as meaning should be interpreted to the effect that prod- that products such as powdered sterile mix- ucts such as that imported by Thyssen tures of amino acids, not put up in forms or should be regarded as falling under heading in packings of a kind sold by retail, and in 30.03. It adds (at p. 18 in fine et seq. of the measured doses (a) should be regarded as French translation) that the same solution falling under tariff heading 30.03 (subheading may be reached on the basis of one of the 30.03 A II (b)) if in fact their sole intended general rules for the interpretation of the use inherent to their particular characteris- nomenclature of the Common Customs Tar- tics, is the manufacture of infusion solutions; iff which are included in the first part, Sec- (b) should be regarded as falling under head- tion I A., of the annex to Regulation N o ing 21.07 if their intended use, inherent to 3618/86 applicable to this case. The Com- their particular characteristics, is for normal mission relies, in particular, on the first sen- human nutrition, directly or after certain tence of General Rule 2(a) (according to processing, or for incorporation in food which '[a] ny reference in a heading to an preparations. In the latter case the mere pos- article shall be taken to include a reference to sibility of other uses of the said products (for that article incomplete or unfinished, pro- vided that, as imported, the incomplete or unfinished article has the essential character of the complete or finished article') and 17 — Emphasis added. 18 — Sec also the CCC Explanatory Notes to heading maintains that if the 'complete or finished 30.03 (B(a)), according to which inter alia 're-distilled article' in question is taken to be the infusion water' put up in measured doses and 'for use either for the direct treatment of certain diseases (...) or as a solvent for solution which results from water being the preparation of injectable mediānal solutions' also falls under that heading. added to the mixture at issue, that mixture

IV — Conclusion

I n v i e w of t h e foregoing, I p r o p o s e t h a t the C o u r t s h o u l d r e p l y t o the questions referred t o it as follows:

T h e C o m m o n C u s t o m s Tariff, as amended b y the A n n e x t o C o u n c i l R e g u l a t i o n ( E E C ) N o 3 6 1 8 / 8 6 , s h o u l d b e interpreted as m e a n i n g t h a t p r o d u c t s such as p o w -

19 — See the judgment in Case C-318/90 Boehringer Mannheim [1992] ECR 1-3495, at paragraphs 17 and 18. See also the judgment in Case 295/81 IFF [1982] ECR 3239.

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