Case C-40/06

Juers Pharma Import-Export GmbH

v

Oberfinanzdirektion Nürnberg

(Reference for a preliminary ruling from the Finanzgericht München)

(First subparagraph of Article 104(3) of the Rules of Procedure – Common Customs Tariff – Combined Nomenclature – Tariff classification – Capsules containing primarily melatonin – Medicaments)

Order of the Court (Fifth Chamber), 9 January 2007

Summary of the Order

Common Customs Tariff – Tariff headings – Capsules containing primarily melatonin





On a proper interpretation of the Combined Nomenclature in Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, tariff heading 3004 covers capsules containing primarily melatonin which, since they principally constitute a treatment for insomnia and the effects of jetlag through their stabilising effect on the human nervous system, have a clearly defined therapeutic or prophylactic purpose and are sold in the form of capsules which each correspond to a daily dose.

(see paras 25-26, 30, operative part)

ORDER OF THE COURT (Fifth Chamber)

9 January 2007 ( )

(First subparagraph of Article 104(3) of the Rules of Procedure – Common Customs Tariff – Combined Nomenclature – Tariff classification – Capsules containing primarily melatonin – Medicaments)

In Case C‑40/06,

REFERENCE for a preliminary ruling under Article 234 EC from the Finanzgericht München (Germany), made by decision of 8 December 2005, received at the Court on 25 January 2006, in the proceedings

Juers Pharma Import-Export GmbH

v

Oberfinanzdirektion Nürnberg,

THE COURT (Fifth Chamber),

composed of R. Schintgen, President of the Chamber, A. Tizzano (Rapporteur) and E. Levits, Judges,

Advocate General: M. Poiares Maduro,

Registrar: R. Grass,

the Court, proposing to give its decision by reasoned order in accordance with the first subparagraph of Article 104(3) of its Rules of Procedure,

after hearing the Advocate General,

makes the following

Order

1 This reference for a preliminary ruling concerns the interpretation of Heading 3004 of the Combined Nomenclature in Annex I to 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), as amended by Commission Regulation (EC) No 1789/2003 of 11 September 2003 (OJ 2003 L 281, p. 1, ‘the CN’).

2 The reference has been made in proceedings between Juers Pharma Import-Export GmbH (‘Juers Pharma’) and the Oberfinanzdirektion Nürnberg (Principal Revenue Office Nuremburg, ‘the OFD’) concerning the classification as a medicament or as a food preparation under the CN of capsules containing primarily melatonin (‘the melatonin capsules’).

Legal context

3 The CN, established by Regulation No 2658/87, is based on the world harmonised system for the description and coding of commodities, from which it takes the six-digit headings and subheadings, only the seventh and eighth digits forming subdivisions specific to the CN. In addition to the CN, the autonomous and conventional rates of duty and the statistical supplementary units are also laid down in Annex I to that regulation.

4 Heading 3004 of the CN in chapter 30 thereof covers ‘[m]edicaments (excluding goods of heading Nos 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or in packings for retail sale’. Goods covered by that heading are exempted from customs duty.

5 Heading 2106 of the CN covers ‘Food preparations not elsewhere specified or included’. The food preparations covered by that heading are, by contrast, subject to customs duty.

The dispute in the main proceedings and the question referred for a preliminary ruling

6 Juers Pharma imports melatonin capsules bearing the mark Twinlab Melatonine Caps into the European Union from the United States. That product is put up as a dietary supplement, and described as such on its label, which bears the words ‘Dietary Supplement’. Thus put up for sale, each capsule represents one daily dose.

7 On 26 January 2004, Juers Pharma applied to the Zolltechnische Prüfungs- und Lehranstalt (Customs Laboratory and Training College, hereinafter the ‘ZPLA’) in Cologne for the issue of binding tariff information classifying the melatonin capsules in issue in the main proceedings under subheading 3004 5010 of the CN as ‘other medicaments containing vitamins or other products of heading 2936, put up in forms or in packings of a kind sold by retail’.

8 On 22 April 2004, the ZPLA in Munich, to which the ZPLA in Cologne had forwarded the request of the applicant in the main proceedings, issued binding tariff information classifying those capsules, as a food preparation in heading 2106, under subheading 2106 9098.

9 Considering that that classification was incorrect, Juers Pharma brought an objection before the OFD which was rejected by decision of 22 May 2005.

10 Juers Pharma brought an appeal against that decision before the Finanzgericht München, claiming that the product in issue in the main proceedings is a medicament and must therefore be classified under heading 3004. That product has a specific therapeutic property because it is effective in curing or alleviating insomnia.

11 OFD submits, by contrast, that the product in issue cannot be classified under heading 3004 as a medicament because it is put up as a dietary supplement, without any indication as to therapeutic or prophylactic uses.

12 In its decision, the national court notes that the product in issue in the main proceedings is automatically classified, as are all preparations containing melatonin, as a medicament under the pharmaceutical legislation applicable in the European Community because of its considerable effect on the human body.

13 According to the findings of the national court, melatonin capsules are intended principally to alleviate or cure insomnia and the effects of jetlag though their stabilising effect on the human nervous system.

14 Indeed, in Germany those capsules can legally be sold only in pharmacies and on prescription.

15 However, the national court questions the validity of the classification of those capsules as a ‘medicament’ within the meaning of heading 3004 of the CN, given that they have for many years been classified as a food preparation in binding tariff information issued in Member States.

16 In those circumstances, the Finanzgericht München decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:

‘Is the [CN] to be interpreted as meaning that melatonin capsules, put up as dietary supplements in the absence of authorisation under the provisions on medicinal products, are to be classified under heading 3004?’

The question referred for a preliminary ruling

17 Under the first subparagraph of Article 104(3) of the Rules of Procedure, where the answer to a question referred to the Court for a preliminary ruling may be clearly deduced from existing case-law, the Court may give its decision by reasoned order.

18 By its question, the Finanzgericht München asks essentially whether products such as the melatonin capsules in issue in the main proceedings fall within heading 3004 of the CN.

19 The national court is inclined to answer that question in the affirmative. Nonetheless, it harbours doubts as to the validity of that assessment given that binding tariff information issued in the Member States classifies those capsules as food preparations under heading 2106 of the CN.

20 In that regard, it is appropriate to recall, at the outset, that any divergent application of the rules in certain Member States cannot influence the interpretation of the Common Customs Code which is based on the wording of the tariff headings (see Case C‑120/90 Post [1991] ECR I‑2391, paragraph 24, and Case C‑495/03 Intermodal Transports [2005] ECR I-8151, paragraph 36).

21 However, it is settled case-law that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods for customs purposes is in general to be found in their objective characteristics and properties as defined in the wording of the relevant heading of the CN and of the notes to the sections or chapters (see Case C‑396/02 DFDS [2004] ECR I‑8439, paragraph 27; Case C‑445/04 Possehl Erzkontor [2005] ECR I‑10721, paragraph 19; and Case C‑196/05 Sachsenmilch [2006] ECR I‑5161, paragraph 22).

22 With regard to heading 3004 of the CN, first, the Court has held that ‘medicaments’ for the purposes of that heading are products with a clearly defined therapeutic or prophylactic purpose with an effect concentrated on precise functions of the human body (see, to that effect, Case C‑177/91 Bioforce [1993] ECR I‑45, paragraph 12; Case C‑405/95 Bioforce [1997] ECR I‑2581, paragraph 18; Case C‑270/96 Laboratoires Sarget [1998] ECR I‑1121, paragraph 28; and Case C‑328/97 Glob-Sped [1998] ECR I‑8357, paragraphs 29 and 30).

23 Second, the Court has held that the fact that those products are put up in measured doses or that they are packaged for retail sale does constitute, as shown by the actual wording of heading 3004, a condition of the application of that provision (see order of the Court in Case C‑206/03 SmithKline Beecham [2005] ECR I‑415, paragraph 34).

24 It is apparent from the order for reference that the melatonin capsules satisfy the two conditions thus defined.

25 First, according to the findings of the national court, those capsules constitute principally a treatment for insomnia and the effects of jetlag through their stabilising effect on the human nervous system. The capsules therefore have a clearly defined therapeutic and prophylactic purpose.

26 Second, as appears from paragraph 6 above, the product in issue is sold in the form of capsules which each correspond to a daily dose.

27 Consequently, for the purposes of classification under the CN, according to the information available to the Court, products such as the melatonin capsules in issue in the main proceedings must be considered as ‘medicaments’ within the meaning of heading 3004.

28 The argument put forward by the OFD that the capsules in issue cannot be classed under that heading because they are put up as a dietary supplement cannot call that categorisation into question.

29 Suffice it to state, as the Court has already held, that there is in neither the wording of heading 3004 nor the notes set out in the introduction to Chapter 30 of the CN for the tariff classification of products in that chapter any reference to the presentation of the product, and therefore such a factor is not decisive as regards classification in the CN (see, to that effect, Case C‑201/96 LTM [1997] ECR I‑6147, paragraph 28; Laboratoires Sarget, paragraph 27; and the order in Smithkline Beecham, paragraph 33). The term ‘dietary supplement’ chosen by the manufacturer for the product in issue in the main proceedings does not, therefore, in any way preclude its tariff classification as a medicament.

30 Having regard to the foregoing, the answer to the question referred is that the CN must be interpreted as meaning that melatonin capsules such as those in issue in the main proceedings fall under tariff heading 3004.

Costs

31 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court.

On those grounds, the Court (Fifth Chamber) hereby orders:

The Combined Nomenclature in Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Commission Regulation (EC) No 1789/2003 of 11 September 2003, must be interpreted as meaning that capsules containing primarily melatonin such as those in issue in the main proceedings fall under tariff heading 3004.

[Signatures]