1 This request for a preliminary ruling concerns the interpretation of tariff headings 3004 and 3808 of the Combined Nomenclature set out 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 Implementing Regulation (EU) No 1101/2014 of 16 October 2014 (OJ 2014 L 312, p. 1; ‘the CN’).
2 The request has been made in proceedings between Samohýl group a. s. (‘Samohýl’) and the Generální ředitelství cel (General Directorate of Customs, Czech Republic) concerning Binding Tariff Informations (‘BTIs’) issued for the product known as ‘Bob Martin Clear 50 mg - spot-on solution for cats’.
3 The customs classification of goods imported into the European Union is governed by the CN, which is based on the Harmonised Commodity Description and Coding System (‘the HS’), which was established by the International Convention on the Harmonised Commodity Description and Coding System, concluded in Brussels on 14 June 1983, under the aegis of the World Customs Organisation (WCO), and approved, with its amending protocol of 24 June 1986, on behalf of the European Economic Community by Council Decision 87/369/EEC of 7 April 1987 (OJ 1987 L 198, p. 1; ‘the HS’).
4 The CN reproduces the HS six-digit headings and subheadings, with only the seventh and eighth figures creating further subheadings which are specific to it.
5 Under Article 12(1) of Regulation No 2658/87, the European Commission adopts, each year, a regulation reproducing the complete version of the CN, together with the rates of duty, as resulting from measures adopted by the Council of the European Union or the Commission. That regulation is to apply from 1 January of the following year.
6 The version of the CN applicable to the facts in the main proceedings is, as is apparent from the file submitted to the Court, the version for the year 2015, resulting from Regulation No 1101/2014.
7 In Section I of Part One, which contains general rules, subsection A, entitled ‘General rules for the interpretation of the Combined Nomenclature’, provides: ‘Classification of goods in the [CN] shall be governed by the following principles: 1. The titles of sections, chapters and sub-chapters are provided for ease of reference only; for legal purposes, classification shall be determined according to the terms of the headings and any relative section or chapter notes and, provided such headings or notes do not otherwise require, according to the following provisions. … 3. When by application of rule 2(b) or for any other reason, goods are prima facie classifiable under two or more headings, classification shall be effected as follows: (a) the heading which provides the most specific description shall be preferred to headings providing a more general description. However, when two or more headings each refer to part only of the materials or substances contained in mixed or composite goods or to part only of the items in a set put up for retail sale, those headings are to be regarded as equally specific in relation to those goods, even if one of them gives a more complete or precise description of the goods; (b) mixtures, composite goods consisting of different materials or made up of different components, and goods put in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, in so far as this criterion is applicable. … … 6. For legal purposes, the classification of goods in the subheadings of a heading shall be determined according to the terms of those subheadings and any related subheading notes. For the purposes of this rule, the relative section and chapter notes also apply, unless the context requires otherwise.’
8 Part Two of the CN, entitled ‘Schedule of customs duties’, is divided into 21 sections. Section VI of that part, entitled ‘Products of the chemical or allied industries’, includes Chapter 30, entitled ‘Pharmaceutical products’, which states, in its additional note: ‘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) method of administration. 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.’
9 Chapter 30 of the CN includes the following heading and subheading: CN Code Description Conventional duty (%) Supplementary unit of measurement (1) (2) (3) (4) … … … … 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 … … … … 3004 90 00 - Other Free - … … … …
10 The CN Explanatory Notes (OJ 2015 C 76, p. 1), adopted pursuant to Article 9(1) of Regulation No 2658/87, in the part relating to Chapter 30 of that nomenclature, state, under the heading ‘General’, that ‘the description of a product as a medicament in Union legislation (other than that relating specifically to classification in the Combined Nomenclature) or in the national legislation of the Member States, or in any pharmacopoeia, is not the deciding factor in so far as its classification in this chapter is concerned.’
11 Chapter 38, also in Section VI of Part Two of the CN, entitled ‘Miscellaneous chemical products’, states, in note 1: ‘This chapter does not cover: (a) separate chemically defined elements or compounds with the exception of the following: … (2) insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up as described in heading 3808; … (d) medicaments (heading 3003 or 3004); …’
12 That chapter includes the following heading and subheadings: CN Code Description Conventional duty (%) Supplementary unit of measurement (1) (2) (3) (4) … … … … 3808 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly papers): … … … … 3808 91 - - Insecticides: 3808 91 10 - - - Based on pyrethroids 6 - 3808 91 20 - - - Based on chlorinated hydrocarbons 6 - 3808 91 30 - - - Based on carbamates 6 - 3808 91 40 - - - Based on organophosphorus compounds 6 - 3808 91 90 - - - Other 6 - … … … …
13 The HS Explanatory Notes relating to heading 3808, to which the CN Explanatory Notes relating to subheadings 38089110 to 38089190 refer, state: ‘… This heading covers a range of products (other than those having the character of medicaments, including veterinary medicaments - heading 3003 or 3004) intended to destroy pathogenic germs, insects (mosquitoes, moths, Colorado beetles, cockroaches, etc.), mosses and moulds, weeds, rodents, wild birds, etc. Products intended to repel pests or used for disinfecting seeds are also classified here. … The products of heading 3808 can be divided into the following groups: (I) Insecticides Insecticides include not only products for killing insects, but also those having a repellent or attractant effect. The products may be in a variety of forms such as sprays or blocks (against moths), oils or sticks (against mosquitoes), powder (against ants), strips (against flies), cyanogen gas absorbed in diatomite or paperboard (against fleas and lice). … This heading also covers products intended to combat acarians (acaricides), molluscs, nematodes (nematocides), rodents (anti-lock products), birds (avicides) and other vermin (products intended to combat lamroes, predators, etc.). …’
14 The HS Explanatory Notes relating to heading 3004(e) exclude from that heading ‘insecticides, disinfectants, etc., of heading 3808, not put up for internal or external use as medicines’.
15 Article 1 of Commission Regulation (EU) No 455/2007 of 25 April 2007 concerning the classification of certain goods in the Combined Nomenclature (OJ 2007 L 109, p. 1). ‘The goods described in column 1 of the table set out in the annex shall be classified within the Combined Nomenclature under the CN codes indicated in column 2 of that table.’
16 The table set out in the annex to that regulation is as follows: Description Classification (CN code) Reasons (1) (2) (3) 1.A preparation in the form of an alcoholic solution put up in pipettes for retail sale. Its composition is as follows: - fipronil (ISO) 10g - butylhydroxyanisol 0.02g (BHA, E 320) - butylhydroxytoluene 0.01g (BHT, E 321) - excipient q.s.p. 100 ml The preparation, containing a substance showing an insecticide and acaricide activity against parasites such as fleas, ticks and lice, is used externally on pets (dogs and cats). … 3808 91 90 Classification is determined by general rules 1, 3a and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 3808, 3808 91 and 3808 91 90. See also HS Explanatory Notes to heading 3808 and subheadings 3808 91 to 3808 99. The preparation does not have a therapeutic or prophylactic effect, within the meaning of heading 3004.
17 On 27 May 2015, Samohýl submitted an application for a BTI, concerning the classification of the product known as ‘Bob Martin Clear 50 mg - spot-on solution for cats’ (‘the product at issue’). It requested that that product be classified under tariff subheading 30049000 of the CN, which provides for exemption from customs duties.
18 That product had been granted marketing authorisation as a veterinary medicinal product. It is intended for cats, is applied to the skin and is intended to treat infestations with fleas, which are eliminated within 24 hours of application, and ticks, which are eliminated within 48 hours or within the week in which it was applied. It is supplied in pipettes of 0.5ml, each containing 50 mg of the active substance fipronilum (fipronil) and the excipients butylated hydroxyanisole E320, butylated hydroxytoluene E321, benzyl alcohol and diethylene glycol monoethyl ether.
19 According to the document entitled ‘Summary of product characteristics’, referred to by the referring court, the product in question comes within the pharmacotherapeutic group ‘Ectoparasiticides for topical use’. Fipronil is described there as an insecticide (flea insecticide) and an acaricide (tick insecticide).
20 On 24 June 2015, the Celní úřad pro Olomoucký kraj (Customs Office for the Region of Olomouc, Czech Republic; ‘the customs authority’) issued a BTI classifying the product at issue under tariff subheading 38089190 of the CN, as an insecticide, applying, by analogy, Regulation No 455/2007. That authority took the view that the classification of that product under CN tariff subheading 30049000, as applied for by Samohýl, could not be accepted, since that product was not a medicinal product within the meaning of CN tariff heading 3004.
21 The administrative appeal brought against that decision having been dismissed, on 17 August 2015, by the Directorate-General for Customs, Samohýl brought an action before the referring court, which, by decision of 16 May 2017, annulled the decision of 17 August 2015 and referred the case back to that Directorate-General.
22 On 17 May 2018, the customs authority issued a new BTI, by which the product at issue was again classified under tariff subheading 38089190 of the CN as an insecticide. The administrative appeal brought against that decision was dismissed on 11 September 2018 by the Directorate-General of Customs.
23 Samohýl then brought an action against the rejection decision before the referring court, arguing that the outcome of the dispute depended on the question of the tariff classification of a product containing the active substance known as fipronil. It stated that, when it had requested the customs authority to classify the product ‘Moxiclear 400 + 100 mg’, intended for dogs with or exposed to the risk of mixed parasitic infestations, which is comparable to the product at issue in the present case, that product had been classified under tariff subheading 30049000 of the CN, without any examination of its prophylactic and therapeutic effects.
24 The referring court states that the substance of the dispute concerns whether the product at issue may be defined as a ‘medicinal product’ under customs legislation. It refers to the ‘French veterinary opinion 2008-2009 (École Nationale Vétérinaire in Toulouse, in Lyons, and Laboratoire de Parasitologie et Mycologie médicale in Lyons)’ submitted by Samohýl, according to which the product is an identical generic form of the product Frontline, manufactured after the end of that product’s patent grace period, it has the same composition and indications for use as that product and was given marketing authorisation in the same way, as a veterinary medicinal product. That court states, first, that the active substance in the Frontline formulation, as is that of the product at issue, is fipronil, and, second, that Frontline has therapeutic and preventive effects, in the sense that it treats infestations of external parasites by eliminating them. It also notes that, in France, BTIs were issued for goods bearing the trade name Frontline, which were all classified under tariff heading 3808 of the CN, in accordance with Regulation No 455/2007.
25 The referring court notes that it is clear from certain documentary evidence that the product at issue has prophylactic effects, that is to say, that it is intended to prevent the appearance of fleas or ticks on an animal and to prevent diseases which originate from the bites of those parasites. It adds that, without the initial destruction of the parasites, secondary infestations of those parasites cannot be treated. It infers therefrom that that product should be classified not under CN tariff heading 3808, as an insecticide, but under tariff heading 3004, more specifically under subheading 30049000 of the CN, as a medicinal product.
26 In that context, the Krajský soud v Ostravě (Ostrava Regional Court, Czech Republic) decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling: ‘Should the product known as “Bob Martin Clear 50 mg - spot-on solution for cats”, made available in pipettes (0.5ml), which contains the active substance fipronil (50 mg per pipette) and the excipients butylated hydroxyanisole E 320, butylated hydroxytoluene E 321, benzyl alcohol and diethylene glycol monoethyl ether, be classified under heading 3004 or heading 3808 of the [CN]?’
27 By its question, the referring court asks, in essence, whether the CN must be interpreted as meaning that a product consisting of a solution intended for cats, which must be applied by local cutaneous route (spot-on) by means of pipettes (0.5ml) and which contains the active substance fipronil (50 mg per pipette), and excipients, such as butylated hydroxyanisole E 320, butylated hydroxytoluene E 321, benzyl alcohol and diethylene glycol monoethyl ether, should be classified under tariff heading 3004 of the CN, as a medicinal product, or under tariff heading 3808 of the CN, as an insecticide.
28 It is appropriate to recall first of all that, when the Court is requested to give a preliminary ruling on a matter of classification for customs purposes, it is now customary to make the point that its task is to provide the national court with guidance on the criteria which will enable that court to classify the products at issue in the main proceedings correctly in the CN, rather than to effect that classification itself. The classification of the goods at issue is the result of a purely factual finding which it is not for the Court to make in the context of a reference for a preliminary ruling (see judgment of 15 May 2019, Korado, C‑306/18, EU:C:2019:414, paragraph 33 and the case-law cited, and order of 3 December 2020, Siebenburgisches Nugat, C‑99/20, not published, EU:C:2020:993, paragraph 25 and the case-law cited).
29 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 section or chapter notes (see, in particular, judgments of 12 July 2012, TNT Freight Management (Amsterdam), C‑291/11, EU:C:2012:459, paragraph 30; of 19 December 2019, Amoena, C‑677/18, EU:C:2019:1142, paragraph 40, and of 26 March 2020, Pfizer Consumer Healthcare, C‑182/19, EU:C:2020:243, paragraph 37).
30 Finally, the Court has repeatedly held that, despite the fact that they do not have binding force, the CN Explanatory Notes and the HS are an important means of ensuring the uniform application of the Common Customs Tariff and, as such, may be regarded as useful aids to its interpretation (see, inter alia, judgment of 15 May 2019, Korado, C‑306/18, EU:C:2019:414, paragraph 35 and the case-law cited, and order of 3 December 2020, Siebenburgisches Nugat, C‑99/20, not published, EU:C:2020:993, paragraph 28 and the case-law cited).
31 In the first place, with regard to tariff heading 3004 of the CN, it must be borne in mind that, on the one hand, in order to classify products in Chapter 30 of the CN, in which that heading is found, it is necessary to examine whether those products have clearly defined therapeutic or prophylactic characteristics with an effect concentrated on precise functions of the animal organism or whether they are capable of being applied in the prevention or treatment of diseases or ailments. On the other hand, a product which, because of its objective characteristics and properties, is naturally intended for medical use may be classified under Chapter 30 of the CN (see, to that effect, judgment of 30 April 2014, Nutricia, C‑267/13, EU:C:2014:277, paragraphs 20 and 21 and the case-law cited).
32 In the present case, it is apparent from the order for reference that the product at issue is intended to destroy parasites, namely fleas and ticks, of the cat. It is applied by local cutaneous route (spot-on). The rate of absorption of the active substance of that product, fipronil, is low in the cat. According to the ‘Summary of Product Characteristics’, the product at issue belongs to the pharmacotherapeutic group ‘Ectoparasiticides for topical use’. In addition, that document describes fipronil as an insecticide and an acaricide which acts by inhibiting the GABA receptor complex, resulting in uncontrolled activity of the central nervous system of insects and acarines and their death.
33 The referring court notes that the product at issue may have a preventative effect against diseases linked to the presence of fleas and ticks on the body of the cat. However, the referring court states that that product does not have therapeutic effects, but brings about the initial destruction of parasites, without which secondary infestations by those parasites cannot be treated.
34 In that regard, the Commission points out that the active substance of the product at issue, fipronil, has an effect on the outer surface of the animal, by eliminating only external parasites which may be carrying various diseases.
35 Thus, it appears that the preventive effect against the various potential infections transmitted by parasites is secondary in relation to the insecticide and acaricide effect of the product at issue. Accordingly, that preventive effect must not be confused with the therapeutic or prophylactic effects which characterise the products coming under tariff heading 3004 of the CN.
36 With regard to the argument put forward by Samohýl before the referring court, that the product ‘Moxiclear 400 + 100 mg’ has been classified under CN tariff heading 3004 as a medicinal product, it is apparent from the order for reference that the product ‘Moxiclear 400 + 100 mg’ contains the active substances imidacloprid and moxidectine, but not fipronil, and that it is intended for dogs suffering from, or at risk from, mixed parasitic infections of an internal or external nature. In its written observations, the Commission states that the active substance moxidectine is absorbed by the skin of the animal and that, once absorbed, it is released throughout the body, acting against many internal parasites, in particular those attacking the circulatory system, the digestive system or the lungs.
37 In those circumstances, it is for the referring court to ascertain whether, as submitted by the Czech Government and the Commission, the product at issue cannot be regarded as having clearly defined therapeutic or prophylactic properties, the effect of which is concentrated on precise functions of the animal’s organism, within the meaning of the case-law cited in paragraph 31 of the present judgment.
38 In that regard, it must be recalled, first, that, in accordance with the HS Explanatory Notes relating to tariff heading 3004, insecticides, disinfectants and others, coming under tariff heading 3808, which are not put up for prophylactic uses in human or veterinary medicine, are excluded from that heading. Second, the Court has previously held that the fact that products benefit, in the Member States in which they are marketed, from a marketing authorisation as medicinal products is not decisive for their classification in Chapter 30 of the CN (see, to that effect, judgment of 15 December 2016, LEK, C‑700/15, EU:C:2016:959, paragraph 36 and the case-law cited).
39 In the second place, with regard to heading 3808 of the CN, it must be noted that, by virtue of Article 1 of Regulation No 455/2007, the preparation described in point 1 of column 1 of the table in the annex to that regulation, in the form of an alcoholic solution put up in pipettes for retail sale, the composition of which is fipronil (ISO) 10g, butylated hydroxyanisole (BHA, E 320) 0.02g, butylated hydroxytoluene (BHT, E 321) 0.01g and excipient q.s.p. 100ml. Point 1 specifies, in addition, that the preparation, containing a substance showing an insecticide and acaricide activity against parasites such as fleas, ticks and lice, is used externally on pets (dogs and cats).
40 It must be borne in mind in that regard that 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. The application by analogy of a classification regulation, such as Regulation No 455/2007, to products similar to those covered by that regulation facilitates a coherent interpretation of the CN and the equal treatment of traders (see, to that effect, judgment of 4 March 2015, Oliver Medical, C‑547/13, EU:C:2015:139, paragraphs 55 and 57 and the case-law cited).
41 In the present case, it is apparent from the order for reference that the product at issue contains the same concentration of the active substance fipronil as the preparation referred to in point 1 of column 1 of the table in the annex to Regulation No 455/2007. It also contains the excipients butylated hydroxyanisole and butylated hydroxytoluene. Thus, the product at issue appears, by its composition, comparable to that preparation.
42 That assessment is corroborated by the statement of reasons for Regulation No 455/2007, which must be taken into account in order to determine the scope of that regulation (see, to that effect, judgment of 19 December 2019, Amoena, C‑677/18, EU:C:2019:1142, paragraph 31 and the case-law cited).
43 First of all, it follows from column 3 of the table in the annex to Regulation No 455/2007 that the classification of the preparation described in point 1 of column 1 of that table is determined by, inter alia, ‘the wording of CN codes 3808, 380891 and 38089190’. That subheading covers‘insecticides’‘other’ than those based on pyrethroids, chlorinated hydrocarbons, carbamates or organophosphorus compounds. Next, reference is made to the ‘HS Explanatory Notes to heading 3808 and subheadings 380891 to 380899’, which state that insecticides are to be understood as goods designed for eliminating insects and that those goods are put up in various forms. Finally, that statement of reasons states that ‘the preparation referred to in point 1 of column 1 of the table set out in the Annex to Regulation No 455/2007 is not intended for therapeutic or prophylactic effect use, within the meaning of heading 3004’.
44 The grounds for the classification of the preparation described in point 1 of column 1 of the table in the Annex to Regulation No 455/2007 under tariff subheading 38089190 of the CN can be transposed to the product at issue. Subject to verification, which it is for the referring court to carry out, that product appears to contain, in the same proportions, the same active substance as that used in the composition of the preparation, as well as the same excipients as the latter. Furthermore, it is apparent from the order for reference that the product at issue has the same function and use as does that preparation, namely an insecticide and acaricide function against parasites such as fleas and ticks and external topical use on domestic animals, namely cats.
45 Having regard to the foregoing considerations, the answer to the question referred is that the CN must be interpreted as meaning that a product consisting of a solution intended for cats, which must be applied by local cutaneous route (spot-on) by means of pipettes (0.5ml) and which contains the active substance fipronil (50 mg per pipette), and excipients, such as butylated hydroxyanisole E 320, butylated hydroxytoluene E 321, benzyl alcohol and diethylene glycol monoethyl ether, comes within tariff heading 3808 of the CN, as an ‘insecticide’, subject to the assessment by the referring court of all the facts at its disposal.
46 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.