Case C‑700/15

LEK farmacevtska družba d.d.

v

Republic of Slovenia

(Request for a preliminary ruling from the Vrhovno sodišče)

(Reference for a preliminary ruling — Combined Nomenclature — Classification of goods — Food supplements falling under heading 2106 — Active ingredient as the essential component — Possible classification in Chapter 30 of the Combined Nomenclature — Goods presented and marketed as medicinal products)

Summary — Judgment of the Court (Sixth Chamber), 15 December 2016

1.        Customs union — Common Customs Tariff — Tariff headings – Goods that fall within the definition of a ‘medicinal product’ within the meaning of Directive 2001/83 — No automatic classification under heading 3004

(Council Regulation No 2658/87, as amended by Regulation No 1006/2011, Annex I; European Parliament and Council Regulation No 2001/83, as amended by Directive 2011/62)

2.        Customs union — Common Customs Tariff — Classification of goods — Criteria — Characteristics and objective properties

3.        Customs union — Common Customs Tariff — Tariff headings — Interpretation — Explanatory notes to the combined nomenclature —Explanatory notes must be consistent with the provisions of the combined nomenclature

4.        Customs union — Common Customs Tariff — Tariff headings — Goods that have beneficial effects on health, the essential component of which is an active ingredient found in food supplements classified under tariff heading 2106 of the CN

(Council Regulation No 2658/87, as amended by Council Regulation No 1006/2011, Annex I)

1.      Heading 3004 of the Combined Nomenclature of the Common Customs Tariff set out in Annex I to Regulation No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, as amended by Regulation No 1006/2011, must be interpreted as meaning that goods which fall within the definition of ‘medicinal product’, within the meaning of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2011/62, are not automatically required to be classified under that heading.

It is clear, first of all, from recitals 2 to 5 of Directive 2001/83 that that directive aims to ensure the approximation of national legislation concerning medicinal products whilst ensuring the attainment of its essential aim, which is the safeguarding of public health.

The classification of a product in one Member State as a medicinal product within the meaning of Directive 2001/83, does not require the competent authorities of another Member State to classify the same product as a medicinal product within the meaning of other instruments of EU law.

Furthermore, it is clear from the eighth recital of Regulation No 2685/87 that the provisions of the CN must be given an identical interpretation by each of the Member States.

Moreover, it follows from the wording of Article 1 of Directive 2001/83 that a medicinal product within the meaning of that directive includes, first, any substance or combination of substances presented for treating or preventing disease in human beings and, second, any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.

Therefore, that definition does not require that products falling within it necessarily comply with the condition for classification in Chapter 30 of the CN, namely that they have clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the human organism or are capable of being applied in the prevention or treatment of diseases or ailments.

Directive 2001/83 pursues different objectives from those pursued by the CN.

(see paras 31-37, operative part 1)

2.      See the text of the decision.

(see para. 39)

3.      See the text of the decision.

(see paras 40, 41)

4.      The Combined Nomenclature of the Common Customs Tariff set out in Annex I to Regulation No 2658/87, as amended by Regulation No 1006/2011, must be interpreted as meaning that goods which have beneficial effects on health and in which the essential component is an active ingredient that is found in food supplements classified under tariff heading 2106 of the CN, although they are presented by their manufacturer as medicinal products and are marketed and sold as such, fall under that heading.

A classification regulation is of general application in so far as it does not apply to an individual trader but, in general, to products which are the same as that examined by the Customs Code Committee. In the interpretation of a classification regulation, in order to determine its scope, account must be taken, inter alia, of its statement of reasons.

It is true that Regulation No 1264/98 and Implementing Regulation No 727/2012 are not directly applicable to the goods at issue in the main proceedings. Those goods are not identical to those covered by that regulation, since they differ in respect of their vehicles and the concentration of micro-organisms.

Nevertheless, the application by analogy of a classification regulation, such as Regulation No 1264/98 and Implementing Regulation No 727/2012, to products similar to those covered by that regulation facilitates a coherent interpretation of the CN and the equal treatment of traders.

It is clear, first, from the wording of point 5 of the Annex to Regulation No 1264/98 and, second, the wording of the Annex to Implementing Regulation No 727/2012, that goods composed of various bacteria colonies and excipients are to be classified under CN heading 2106, having regard to the general rules for the interpretation of the CN, to the wording of note 1(a) of Chapter 30 and to the CN headings 2106, 2106 90 and 2106 90 98. Thus, those goods have the same active ingredient as the goods classified by Regulation No 1264/98 and Implementing Regulation No 727/2012 and the only differences between the two are the concentration of the micro-organisms and the excipients used.

It follows that those goods in which the essential component is an active ingredient that is contained in the food supplements classified under tariff heading 2106 of the CN and which have beneficial effects on health fall under CN heading 2106.

(see paras 49-54, operative part 2)