Judgment;Summary — ECLI:EU:C:2021:192
Date: 2021-03-10
Language of the case: Czech
Court formation: Ninth Chamber
Subject matter: Free movement of goods;Common customs tariff;Customs Union
Procedure: Reference for a preliminary ruling
Origin: Czechia

Summary of Product 
Characteristics’ that the product belongs to the pharmacotherapeutic group 
‘Ectoparasiticides for topical use’. Fipronil is described there as an insecticide 
(flea insecticide) and acaricide (tick insecticide) which inhibits the GABA 
receptor complex, resulting in uncontrolled activity of the central nervous system 
and death of insects or acarines. It is important to note that although fipronil used 
in vitro metabolises in the subcellular liver fraction mainly to sulfone metabolite, 
this may be of limited importance in vivo, since fipronil is absorbed to a small 
extent in cats and its concentration on the hair coat decreases with time. The 
solution is not to be applied to the hair coat but to the skin and should not be 
rubbed into the skin. 
9 According to the ‘sdělení Ústavu pro státní kontrollí veterinárních [biopreparátů a] 
léčiv’ (Communication from the Institute for State Control of Veterinary 
Preparations and Medicinal Products) (‘the institute’) of 14 January 2014, the 
product was authorised to be marketed as a veterinary medicinal product. The 
applicant has mentioned this fact on several occasions. [Or. 3] 
10 It is apparent from the ‘odborné[ho] vyjádření ÚSKVBL’ (expert opinion of the 
institute) of 22 November 2017 that fleas and ticks cause skin diseases, changes in 
blood morphology, including neurological changes such as paralysis and apathy, 
and enlargement of the lymph nodes, and at the same time may cause, as carriers, 
borreliosis, babesiosis, and so on. If parasites are effectively eliminated on an 
animal, it can be assumed that they cannot cause the aforementioned illnesses in 
that animal. The product in question works in such a way that it eliminates fleas 
and ticks. 
11 According to the ‘French veterinary opinion 2008–2009 (Ecole Nationale 
Vétérinaire in Toulouse, in Lyon, and Laboratoire de Parasitologie et Mycologie 
médicale in Lyon)’ submitted by the applicant, the product is an identical generic 
form of the product Frontline, manufactured after the end of the patent grace 
period, has the same composition and indications for use and was given marketing 
authorisation in the same way. The active substance in the Frontline formulation, 
as in the product under consideration, is fipronil, and this agent has therapeutic 
and preventive effects in the sense that it treats infestations of external parasites 
by eliminating them. Because fipronil accumulates in the sebaceous glands of the 
animal and is released gradually, it also has a preventive effect. 
12 In France, the BTI was issued for a product with the trade name Frontline. All the 
products in this BTI were classified under HS heading 3808, with reference to 
Commission Regulation (EC) No 455/2017 (BTI No […] [individual BTI 
numbers issued in France]). It was further established that Frontline was also 
authorised to be marketed as a veterinary medicinal product. 
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13 The customs office also examined existing BTIs issued in regard to identical or 
similar products in other Member States of the European Union, where the 
product took the same form (solution put up in pipettes with the same 
concentration of the active substance fipronil), and found them in the case of BTI 
Nos […] [individual BTI numbers issued in Slovenia]. All those products are 
intended for animals and have an insecticidal and acaricidal effect (some also 
eliminate lice). 
14 It is apparent from ‘the BTI of 15 October 2018 […]’ that Moxiclear 400 + 100 
mg, which is a veterinary medicinal product in the form of a solution, is intended 
for dogs suffering from, or at risk from, mixed parasitic infections of an internal or 
external nature, which is administered by topical application to the skin and 
contains the active substances imidacloprid and moxidectin and the excipients 
butylated hydroxytoluene E 321 and benzyl alcohol, and which is classified under 
CN subheading 3004 90 00. The product is available in pipettes (0.4 ml), in 
packages intended for retail sale. 
15 In its submissions, the applicant essentially argued that the defendant had assessed 
the various pieces of evidence separately, and that if it had compared the findings 
of the Summary of Product Characteristics with the marketing authorisation 
decision, the institute’s expert opinion and the French veterinary opinion, it could 
not have come to the conclusion that the product is intended for the elimination of 
insects, but that it is intended to treat flea infestations, and that insecticides are 
commonly used for the elimination of insects and are currently regarded not as 
medicaments to treat insect infestations but as agents for their eradication. 
According to the applicant, however, the institute’s expert opinion cited above 
clearly indicates that the product has therapeutic and preventive effects; it explains 
what kind of ailments are caused in animals by fleas and ticks and that without 
treatment to eliminate the cause (flea infestation) it is not possible to cure the 
symptoms of the disease; and it also confirms that the product has a permanent, 
long-term effect, which is important from a preventive perspective. 
 
III. The applicable legislation and case-law of the Court of Justice of the 
European Union 
16 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 
Implementing Regulation (EU) 2017/1925, should have been applied in the 
present case and Commission Regulation (EC) No 455/2007 of 25 April 2007 
concerning the classification of certain goods in the Combined Nomenclature 
should have been taken into account. Article 1 of the latter regulation provides 
that the goods described in column 1 of the table set out in the Annex must be 
classified within the Combined Nomenclature under the CN codes indicated in 
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column 2 of that table. In the present case, the customs authority applied point 1 
of the Annex, according to which: [Or. 4] 
Description of the goods Classification 
(CN Code) 
Reasons 
(1) (2) (3) 
 A preparation in the form of an 
alcoholic solution put up in pipettes for 
retail sale. The composition is as 
follows: 
– fipronil (ISO) 10 g 
– butylated hydroxyanisole 
(BHA, E 320) 
0.02 g 
–  butylated hydroxytoluene 
(BHT, E 321) 
0.01 g 
– 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 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 Contrary to the foregoing, the applicant’s line of argument is that the product 
should be classified under CN subheading 3004 90 00 as follows: 
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 – 
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18 The Court of Justice has not yet dealt with the classification of the product under 
consideration or other similar products under Customs Tariff headings 3004 or 
3808. 
19 Since the basis of the dispute was whether the product could be defined as a 
‘medicament’ within the meaning of customs legislation, the order of the Court of 
Justice of 9 January 2007, Juers Pharma, C-40/06, EU:C:2007:2, in which the 
Court ruled on a question referred for a preliminary ruling regarding the 
interpretation of heading 3004 of the CN, must be regarded as relevant. In that 
order (paragraph 22), the Court of Justice stated that ‘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)’. 
20 In relation to this definition of a medicament, it is also necessary to take account 
of the judgment of the Court of Justice of 30 April 2014, Nutricia, C-267/13, 
EU:C:2014:277, in which, in paragraphs 20 to 23 thereof, the Court held that ‘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, TNT Freight Management (Amsterdam) 
EU:C:2012:459, paragraphs 40 and 42). [Or. 5] It is apparent from the case-law 
cited in the two preceding paragraphs 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 must be capable of being assessed on 
the basis of the product’s objective characteristics and properties (see, inter 
alia, Krings EU:C:2004:122, paragraph 30 and the case-law cited). 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 Thyssen Haniel Logistic EU:C:1995:160, 
paragraph 14, and TNT Freight Management (Amsterdam) EU:C:2012:459, 
paragraph 41). It must be added that the Court has already held, relying on the 
actual wording of heading 3004, that the fact that products are put up in 
measured doses or that they are packaged for retail sale constitutes a 
condition of the application of that provision (see order in Case C-40/06 Juers 
Pharma EU:C:2007:2, paragraph 23 and the case-law cited). It is also important to 
note that the question of whether or not an illness is recognised in a measure 
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of EU law other than those that refer to classification in the CN is not a 
decisive factor for the classification of a product under heading 3004 thereof (see, 
to that effect, order in Case C-206/03 SmithKline Beecham EU:C:2005:31, 
paragraph 44)’. 
21 The customs office applied Commission Regulation (EC) No 455/2007, which it 
considered binding and which it could not derogate from, since an unlawful 
decision would otherwise have been taken. In that context, however, the Regional 
Court draws attention to the judgment of the Court of Justice of 15 May 2019, 
Korado, C-306/18, EU:C:2019:414, in which the Court once again held that 
where, by its answer to the question referred for a preliminary ruling, it has 
provided the referring court with all the information necessary to classify a 
product under the appropriate heading of the CN, it is not necessary to apply 
the implementing regulation (see, to that effect, judgment of 26 April 2017, 
Stryker EMEA Supply Chain Services, C-51/16, EU:C:2017:298, paragraph 62). 
Having regard to the foregoing, it must be assumed that, if the Court of Justice 
comes to a different/similar conclusion, its judgment takes precedence over the 
application of the cited regulation. 
IV. Analysis and admissibility of the question referred 
22 The product was classified under heading 3808 of the CN mainly on the basis of 
Commission Regulation (EC) No 455/2007, under which products containing the 
active substance fipronil in the quantity indicated therein are to be classified solely 
under that heading of the Combined Nomenclature. However, the Regional Court 
is of the view that, in the present case, account must be taken of the objective 
characteristics of the product in question and its preventive effect. As has already 
been stated above, although its only active substance is fipronil, which is 
classified as an insecticide and acaricide, the product has a preventive effect but 
no therapeutic effect, and without its use it is impossible to prevent the occurrence 
of diseases associated with fleas and ticks on the body of a cat. 
23 The Regional Court considers that, contrary to the defendant’s assertions, the 
product should not be classified under heading 3808 of the Combined 
Nomenclature, but under heading 3004, specifically under subheading 3004 90 00. 
This is because, according to the documents submitted, the product has a 
prophylactic effect, in other words, it inherently prevents the occurrence of fleas 
(as well as ticks) on the animal and thus prevents diseases caused precisely by 
bites from those parasites. Were it not for the initial elimination of the parasites, 
and thus prevention, it would not be possible to treat the secondary symptoms of 
infestation by those parasites. According to the Regional Court, the specific effect 
of the product on the animal’s organism is that the active substance present in the 
product accumulates in the sebaceous glands of the animal (in this case, the cat), 
from where it is released gradually, and thus it has a preventive effect for a longer 
period of time after its application and prevents parasitic infestation over a longer 
period. According to that court, the product in question is used primarily to 
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prevent secondary diseases caused by flea and tick bites, as stated in paragraph 10 
above. 
24 Although it is not possible to link the recognition of a product as a veterinary 
product (medicine) with the recognition of a product as a medicament within the 
meaning of customs legislation, at this juncture note should be taken of the 
wording of Directive 2001/82/EC of the European Parliament and of the Council 
of 6 November 2001 on the Community code relating to veterinary medicinal 
products, according to which marketing authorisation is to be refused [Or. 6] 
where a medicinal product has no therapeutic effect. A veterinary medicinal 
product, in accordance with Article 4(1) of Regulation (EU) 2019/6 of the 
European Parliament and of the Council of 11 December 2018 on veterinary 
medicinal products and repealing Directive 2001/82/EC, means any substance or 
combination of substances which fulfils at least one of the following conditions: 
(a) it is presented as having properties for treating or preventing disease in 
animals; (b) its purpose is to be used in, or administered to, animals with a view to 
restoring, correcting or modifying physiological functions by exerting a 
pharmacological, immunological or metabolic action; (c) its purpose is to be used 
in animals with a view to making a medical diagnosis; (d) its purpose is to be used 
for euthanasia of animals. Therefore, since the product has been authorised to be 
marketed as a veterinary medicinal product, it must be considered to have 
therapeutic (and possibly prophylactic) effects, and it is not permissible to classify 
it under heading 3808 instead of heading 3004 of the CN simply because it 
contains the active substance fipronil. 
25 The Regional Court is aware that similar products have, according to the BTI cited 
in paragraph 13 above, been classified under heading 3808 of the CN. However, 
there is also a similar product, ‘Moxiclear’, which is intended for dogs and 
contains a different active substance, but which has the same effect on the body of 
a dog as the product under consideration has on the body of a cat. The question 
therefore arises as to whether the purpose of [Commission Regulation] 
No 455/2007 was also to classify under heading 3808 products similar to the 
product under consideration, or to classify under that heading only insecticides 
and acaricides which have a one-off action, do not accumulate in any way in the 
body of the animal and have no preventive effect, and only eliminate parasites 
once, immediately after application. This fact also militates in favour of the view 
of the Regional Court as set out in paragraph 22 above. 
26 The product has other characteristics of a medicament within the meaning of 
heading 3004 of the CN. It is made available in 0.5 ml pipettes, that is, in 
measured doses, in packages intended for retail sale. 
27 Although the Regional Court has already set out its view on the possible answer to 
the question referred, that answer is not sufficiently clear and indisputable to 
enable it to give a ruling in the case. In this instance, the interpretation of EU law 
(the Customs Tariff and the Combined Nomenclature) is necessary for the specific 
application of the law in the present case. There is no previous case-law of the 
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Court of Justice, relevant to the answer to the question referred for a preliminary 
ruling, on the basis of which an interpretation of the law could […] be deduced 
directly and with absolute certainty. For that reason, the Regional Court has 
decided to ask the Court of Justice of the European Union for a preliminary ruling 
on the question referred in the operative part of this order. 
V. Stay of proceedings 
28  […] [procedural issues relating to national law] 
Notice: 
 […] [information on the legal remedies available] 
Ostrava, 13 December 2019. 
[…] [signature][…]