CELEX: 62014CJ0344
Reference for a preliminary ruling
Tariff and statistical nomenclature
Classification of goods
Amino acid mixes used for the preparation of foodstuffs for infants and young children allergic to cow’s milk proteins
Classification under tariff headings 2106 ‘food preparations’ or 3003 ‘medicinal products’

This request for a preliminary ruling concerns the interpretation of headings 2106 and 3003 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 1214/2007 of 20 September 2007 (
OJ 2007 L 286, p. 1
; ‘the CN’).
The request has been made in proceedings between Kyowa Hakko Europe GmbH (‘Kyowa Hakko’) and the Hauptzollamt Hannover (Principal Customs Office, Hanover; ‘the Hauptzollamt’) concerning Binding Tariff Informations (‘BTIs’) relating to the classification of amino acid mixes used for the preparation of foodstuffs for infants and young children allergic to cow’s milk proteins.
Legal context
The CN, instituted by Regulation No 2658/87, is based on the Harmonised Commodity Description and Coding System, which was drawn up by the Customs Cooperation Council, now the World Customs Organisation (WCO), and established by the International Convention on the Harmonised Commodity Description and Coding System, concluded in Brussels on 14 June 1983 (‘the HS’). That convention, and the Protocol of Amendment thereto of 24 June 1986, was approved on behalf of the European Economic Community by Council Decision 87/369/EEC of 7 April 1987 (
OJ 1987 L 198, p. 1
).
Part Two of the CN, entitled ‘Schedule of Customs Duties’, includes Section IV, of which, inter alia, Chapter 21, entitled ‘Miscellaneous edible preparations’, forms part.
Chapter 21 of the CN includes heading 2106, which is worded as follows:
‘2106 Food preparations not elsewhere specified or included.’
That Chapter 21 also includes the following subheadings:
‘2106 10- Protein concentrates and textured protein substances:……2106 90- Other:……- — Other:2106 90 92- — - Containing no milk fats, sucrose, isoglucose, glucose or starch or containing, by weight, less than 1.5% milk fat, 5% sucrose or isoglucose, 5% glucose or starch.’
Note 1 to Chapter 21 is worded as follows:
‘This chapter does not cover:
…
(f)
yeast put up as a medicament or other products of heading 3003 or 3004;
…’
Part Two of the CN, entitled ‘Schedule of Customs Duties’, also includes Section VI, of which, inter alia, Chapter 30, entitled ‘Pharmaceutical products’, forms part.
Chapter 30 of the CN includes heading 3003, which is worded as follows:
‘3003 Medicaments (excluding goods of heading No 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale.’
Chapter 30 also includes the following subheadings:
‘3003 10 00
- Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
3003 20 00
- Containing other antibiotics

- Containing hormones or other products of heading 2937 but not containing antibiotics:
…
…
3003 40 00
- Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 2937 or antibiotics:
…
…
3003 90
- Other.’
Chapter 30 of the CN includes heading 3004, which is worded as follows:
‘3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.’
Note 1 to Chapter 30 of the CN is worded as follows:
‘This chapter does not cover:
(a)
foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV).’
Additional note 1 to Chapter 30 of the CN states:
‘Heading 3004 includes herbal medicinal preparations and preparations based on the following active substances: vitamins, minerals, essential amino acids or fatty acids, in packings for retail sale. These preparations are classified in heading 3004 if they bear on the label, packaging or on the accompanying user directions the following statements of:
(a)
the specific diseases, ailments or their symptoms for which the product is to be used;
(b)
the concentration of active substance or substances contained therein;
(c)
dosage, and
(d)
mode of application.
This heading includes homeopathic medicinal preparations when they meet the conditions of (a), (c) and (d) mentioned above.
In the case of preparations based on vitamins, minerals, essential amino acids or fatty acids, the level of one of these substances per recommended daily dose indicated on the label must be significantly higher than the recommended daily allowance to maintain general health or well-being.’
Furthermore, the Explanatory Notes to the HS published by the World Customs Organisation (2007 edition), concerning heading 30.03 of the HS, corresponding to heading 3003 of the CN (‘the Explanatory Notes to the HS’), state, in particular, as follows:
‘The provisions of the heading text do not apply to foodstuffs or beverages such as dietetic, diabetic or fortified foods, tonic beverages or mineral waters (natural or artificial), which fall to be classified under their own appropriate headings. This is essentially the case as regards food preparations containing only nutritional substances. The major nutritional substances in food are proteins, carbohydrates and fats. Vitamins and mineral salts also play a part in nutrition.
Similarly foodstuffs and beverages containing medicinal substances are excluded from the heading if those substances are added solely to ensure a better dietetic balance, to increase the energy-giving or nutritional value of the product or to improve its flavour, always provided that the product retains its character of a foodstuff or a beverage.
…
Further, this heading excludes food supplements containing vitamins or mineral salts which are put up for the purpose of maintaining health or well-being but have no indication as to use for the prevention or treatment of any disease or ailment. These products, which are usually in liquid form but may also be put up in powder or tablet form, are generally classified in heading 21.06 or Chapter 22.
On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a support, vehicle or sweetening agent for the medicinal substances (e.g., in order to facilitate ingestion).’
The dispute in the main proceedings and the questions referred for a preliminary ruling
Kyowa Hakko produces amino acid mixes, called RM0630 and RM0789, which are composed of various individual amino acids of a very high degree of purity (‘the goods at issue’). The goods at issue are manufactured in such a way that they do not contain cow’s milk proteins. Kyowa Hakko supplies those goods, in bulk, to another undertaking which uses them, adding to them carbohydrates and fats, to prepare foodstuffs for infants and young children who are allergic to cow’s milk proteins. By replacing the cow’s milk protein allergens, the goods at issue provide the substances necessary to the development of the immune system and growth of those children.
By a request dated 12 August 2008 made to the Bundesfinanzdirektion B (Federal Revenue Office B), the German customs authority authorised to issue BTIs, Kyowa Hakko requested the issue of BTIs on the classification of the goods at issue in the CN. In that request, it proposed that the goods be classified under subheading 3003 90 of the CN. On 23 October 2008, that authority issued BTIs classifying those goods under a subheading of heading 2106 of the CN, namely subheading 2106 90 92.
On 24 November 2008, Kyowa Hakko brought a complaint before the Hauptzollamt, disputing the classification of the goods at issue in the CN laid down by the Bundesfinanzdirektion B. In that complaint, it argued that the goods at issue ought to be classified under heading 3003 of the CN on the ground that they were processed into goods used principally for therapeutic purposes in cases of allergy to cow’s milk protein, allergies to other foodstuffs and diseases of the digestive system and also prophylactically. By decision of 5 January 2011 the Hauptzollamt rejected that complaint as unfounded.
On 1 February 2011, Kyowa Hakko brought an action before the Finanzgericht Hamburg (Finance Court, Hamburg) against that decision. By a decision of 19 September 2012, that court dismissed the action, holding that the goods at issue should not be classified under heading 3003 of the CN. In its decision, that court, relying on the Explanatory Notes to the HS, noted in particular that the goods at issue, which supply merely the protein components necessary to human diet, must be regarded, in the applicable system of the CN, as ‘nutritional substances’ and not as ‘active medicated substances’, so that they should not be classified as ‘medicinal products’ but rather as ‘food preparations’. Furthermore, in the view of that court, the goods at issue have no therapeutic effect.
On 2 November 2012, Kyowa Hakko lodged an appeal on points of law before the referring court against the decision of the Finanzgericht Hamburg. In that appeal, Kyowa Hakko maintains its argument that the goods at issue should be classified under heading 3003 of the CN. In essence, it submits that the Explanatory Notes to the HS do not have legally binding force. In that regard, it also refers to a decision of the Upper Tribunal (Tax and Chancery Chamber) (United Kingdom) of 27 September 2013, delivered on appeal, which classified the same amino acid mix as that at issue in the main proceedings under heading 3003 to the CN.
In the request for a preliminary ruling, the referring court notes, in essence, that the CN does not provide any definition of the notion of ‘medicinal product’. None the less, it is of the view that the goods at issue cannot be classified as ‘medicinal products’, for the purposes of heading 3003 of the CN. In that regard, that court is of the opinion that those goods, used as a substitute for milk product allergens for as long as the immune system of a child allergic to cow’s milk proteins is not fully developed, do not appear to have a therapeutic or prophylactic purpose. The goods at issue replace only a pathogenic component of the normal diet of an infant, without acting on the allergy to cow’s milk proteins and without treating or reducing it.
However, although it considers that the goods at issue must be classified under heading 2106 of the CN and that the decisions adopted to that effect by both the Hauptzollamt and the Finanzgericht Hamburg are well founded, the referring court considers that, having regard to the different position set out in the decision of the Upper Tribunal (Tax and Chancery Chamber) of 27 September 2013, it is necessary to obtain a preliminary ruling from the Court in order to state the correct classification of those goods in the CN and, accordingly, to ensure a uniform interpretation of the law in the EU.
In those circumstances, the Bundesfinanzhof (Federal Finance Court) decided to stay the proceedings and refer the following questions to the Court of Justice for a preliminary ruling:
‘(1)
Do amino acid mixes such as those at issue in the present case (RM0630 and RM0789), from which (in combination with carbohydrates and fats) a foodstuff is manufactured by which a substance that is vital for health and present in normal diet but which can in individual cases trigger an allergic reaction is replaced and, as a result, allergy-induced health impairments can be avoided and existing complaints alleviated, if not cured, constitute medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses within the meaning of heading 3003 of the [CN]?
(2)
If the answer to Question 1 is in the negative, do the amino acid mixes constitute food preparations under heading 2106 of the [CN] which, pursuant to note 1(a) to Chapter 30 of the [CN], are excluded from Chapter 30 because they have no prophylactic or therapeutic effect beyond the supply of nutrition?’
Consideration of the questions referred
By its questions, which it is appropriate to examine together, the referring court asks, in essence, whether the CN must be interpreted as meaning that amino acid mixes, such as those at issue in the main proceedings, which are used in the preparation of foodstuffs for infants and young children who are allergic to cow’s milk proteins, must be classified under heading 3003 of the CN, as ‘medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses’, or under heading 2106 of that nomenclature, as ‘food preparations’.
First of all, it must be pointed out that, when the Court is requested to give a preliminary ruling on a matter of tariff classification, its task is to provide the national court with guidance on the criteria which will enable the latter to classify the products at issue correctly in the CN, rather than to effect that classification itself,
a fortiori
since the Court does not necessarily have available to it all the information which is essential in that regard. In any event the national court is in a better position to do so (see judgments in
Proxxon
, C‑500/04,
EU:C:2006:111
, paragraph 23;
Digitalnet and Others
, C‑320/11, C‑330/11, C‑382/11 and C‑383/11,
EU:C:2012:745
, paragraph 61; and
Vario Tek
, C‑178/14,
EU:C:2015:152
, paragraph 18).
Next, it should be recalled that it is settled case-law of the Court that, in the interests of legal certainty and ease of verification, the decisive criterion for the classification of goods is in general to be sought 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, inter alia, judgments in
Thyssen Haniel Logistic
, C‑459/93,
EU:C:1995:160
, paragraph 8, and
Nutricia
, C‑267/13,
EU:C:2014:277
, paragraph 19 and the case-law cited).
It is also settled case-law that the Explanatory Notes, drawn up by the Commission as regards the CN and by the WCO as regards the HS, are an important aid for interpreting the scope of the various tariff headings but do not have legally binding force (see, inter alia, judgment in
TNT Freight Management (Amsterdam)
, C‑291/11,
EU:C:2012:459
, paragraph 32).
Having regard to the objective characteristics and properties of the goods at issue, which are amino acids mixes manufactured in such a way that they do not contain cow’s milk proteins and are used in the preparation of foodstuffs for infants and young children, those goods ought, in principle, to fall under Chapter 21 of the CN, entitled ‘Miscellaneous edible preparations’ and, accordingly, be classified under heading 2106, entitled ‘Food preparations not elsewhere specified or included’.
However, it follows from note 1(f) to Chapter 21 that ‘other products of heading 3003 or 3004’ are excluded therefrom, that is to say, products to be classified as ‘medicaments’ within the meaning of the latter headings. The question therefore arises whether the goods at issue must be given that classification.
In accordance with settled case-law, in order to classify products in Chapter 30 of the CN, it is necessary to examine whether those products have clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the human organism or whether they are capable of being applied in the prevention or treatment of diseases or ailments. Even where the product in question does not have an intrinsic therapeutic effect, but is used in the prevention or treatment of a disease or ailment, it must, provided that it is specifically intended for such a use, be regarded as having been prepared for therapeutic use (see, inter alia, judgment in
Nutricia
, C‑267/13,
EU:C:2014:277
, paragraph 20).
It follows from the case-law cited in paragraphs 25 and 29 of the present judgment that the intended use of a product may constitute an objective criterion for classification if it is inherent to the product and that inherent character is capable of being assessed on the basis of the product’s objective characteristics and properties. According to the case-law of the Court, a product which, on account of its objective characteristics and properties, is clearly intended for medical use may be classified in Chapter 30 of the CN (see judgments in
Thyssen Haniel Logistic
, C‑459/93,
EU:C:1995:160
, paragraphs 13 and 14, and
Nutricia
, C‑267/13,
EU:C:2014:277
, paragraph 21).
In the present case, as has been noted in paragraph 23 of the present judgment, the goods at issue are used in the preparation of foodstuffs for infants and young children who are allergic to cow’s milk proteins. Such goods cannot be classified in Chapter 30 of the CN unless, because of their objective characteristics and properties, they themselves have a therapeutic or prophylactic effect or, at the very least, are naturally intended for medical use, which it is for the national court to ascertain.
In that regard, it must be pointed out, firstly, that goods which, without being capable of acting on the allergy or to cure it, are used purely as substitutions, which serve only to replace those protein allergens by supplying non-allergenic protein components necessary for the diet of those infants without, none the less, themselves alone, bringing about the disappearance of that allergy, cannot be regarded as having a therapeutic effect themselves with regard to the infants who are allergic to cow’s milk proteins.
Secondly, goods which, when administered to an allergic infant who has ingested cow’s milk protein allergens, do not enable that infant to avoid an allergic reaction to those proteins but which rather serve to reduce or remove the protein allergens from the diet of the infant concerned by providing a non-allergenic substitute foodstuff, cannot be regarded as themselves having a prophylactic effect intended to prevent an illness or ailment.
Thirdly, goods from which foodstuffs for infants are manufactured which are not necessarily consumed as part of a medical treatment and whose consumption does not require additional medical supervision cannot be regarded as being naturally intended for medical use within the meaning of the case-law of the Court cited in paragraphs 29 and 30 of the present judgment. In addition, such goods, which cannot be used either as a support, excipient or sweetener in medical substances in order to facilitate their absorption, in accordance with the Explanatory Notes to the HS, cannot be classified under heading 3003 of the CN.
Furthermore, it is clear from the actual wording of note 1(a) to Chapter 30 of the CN that dietetic foods or beverages, other than nutritional preparations for intravenous administration, which, without being part of the daily diet, are nevertheless used purely for feeding purposes are excluded from that chapter (see, to that effect, judgment in
Nutricia
, C‑267/13,
EU:C:2014:277
, paragraph 28). It follows therefrom that goods manufactured solely for nutritional preparations which form part of the daily diet cannot be classified as ‘medicaments consisting of constituents which have been mixed together for therapeutic or prophylactic uses’ within the meaning of heading 3003 of the CN.
It follows, in addition, from the Explanatory Notes to the HS that food preparations containing only nutritional substances cannot be classified as ‘medicaments’ under heading 30.03 of the HS, corresponding to heading 3003 of the CN (see, to that effect, judgment in
LTM
, C‑201/96,
EU:C:1997:523
, paragraph 48). That is the case in particular of goods which are purely substitute foodstuffs and contain no active medicinal substance as regards allergies.
Having regard to all the foregoing considerations, the answer to the questions referred is that the CN must be interpreted as meaning that amino acid mixes, such as those at issue in the main proceedings, which are used in the preparation of foodstuffs for infants and young children who are allergic to cow’s milk proteins, must be classified under heading 2106 of that nomenclature as ‘food preparations’ since, because of their objective characteristics and properties, those goods do not have clearly defined therapeutic or prophylactic characteristics, with an effect concentrated on precise functions of the human organism and, accordingly, are not capable of being applied in the prevention or treatment of diseases or ailments and also are not naturally intended for medical use, which it is for the national court to ascertain.
Costs
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. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Seventh Chamber) hereby rules:

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 1214/2007 of 20 September 2007, must be interpreted as meaning that amino acid mixes, such as those at issue in the main proceedings, which are used in the preparation of foodstuffs for infants and young children who are allergic to cow’s milk proteins, must be classified under heading 2106 of that nomenclature as ‘food preparations’ since, because of their objective characteristics and properties, those goods do not have clearly defined therapeutic or prophylactic characteristics, with an effect concentrated on precise functions of the human organism and, accordingly, are not capable of being applied in the prevention or treatment of diseases or ailments and also are not naturally intended for medical use, which it is for the national court to ascertain.

[Signatures]
(
*1
)	Language of the case: German.