Judgment of the Court (Ninth Chamber) of 11 June 2026. – Prokurator Prokuratury Rejonowej w Jarosławiu v V.B.

1

This request for a preliminary ruling concerns the interpretation of Article 1, Article 2(j) and (t) and Article 7(3) of Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (OJ 1997 L 61, p. 1), as amended by Regulation (EC) No 398/2009 of the European Parliament and of the Council of 23 April 2009 (OJ 2009 L 126, p. 5) (‘Regulation No 338/97’).

2

The request has been made in criminal proceedings against V.B., a Ukrainian national, accused of having introduced into the European Union, without an import permit, boxes of tablets containing extract of Japanese seahorse, a species protected under Regulation No 338/97.

3

The Convention on International Trade in Endangered Species of Wild Fauna and Flora, signed in Washington on 3 March 1973 (United Nations Treaty Series, Vol. 993, No I-14537; ‘CITES’) seeks to ensure that international trade in species listed in its appendices, and in parts and derivatives thereof, does not damage the conservation of biodiversity and is based on a sustainable use of wild species.

4

CITES, to which the European Union became a party on 8 July 2015, was implemented in the European Union as from 1 January 1984 under Council Regulation (EEC) No 3626/82 of 3 December 1982 on the implementation in the Community of the Convention on international trade in endangered species of wild fauna and flora (OJ 1982 L 384, p. 1). That regulation was repealed by Regulation No 338/97.

5

Under the terms of the Resolution of the Conference of the Parties to CITES, entitled ‘Control of trade in personal and household effects’ (Conf.13.7 (Rev. CoP17 )) (‘Resolution 13.7 of the Conference of the Parties to CITES’):

‘…

The Conference of the Parties to [CITES]

…’

6

Article 1 of Regulation No 338/97, entitled ‘Object’, provides:

‘The object of this Regulation is to protect species of wild fauna and flora and to guarantee their conservation by regulating trade therein in accordance with the following Articles.

This Regulation shall apply in compliance with the objectives, principles and provisions of the Convention defined in Article 2.’

7

Article 2 of that regulation, entitled ‘Definitions’, provides, in points (b), (j) and (t):

‘For the purposes of this Regulation:

…

…

…

8

Article 4 of that regulation, entitled ‘Introduction into the Community’, provides, in the first subparagraph of paragraph 2 thereof:

‘The introduction into the [European] Community of specimens of the species listed in Annex B shall be subject to completion of the necessary checks and the prior presentation, at the border customs office at the point of introduction, of an import permit issued by a management authority of the Member State of destination.’

9

Article 7 of that regulation, entitled ‘Derogations’, provides, in paragraph 3 thereof:

‘By way of derogation from Articles 4 and 5, the provisions therein shall not apply to dead specimens, parts and derivatives of species listed in Annexes A to D which are personal or household effects being introduced into the Community, or exported or re-exported therefrom, in compliance with provisions that shall be specified by the [European] Commission. …’

10

Article 16 of Regulation No 338/97, entitled ‘Sanctions’, provides, in paragraphs 1(a) and 2 thereof:

‘1.   Member States shall take appropriate measures to ensure the imposition of sanctions for at least the following infringements of this Regulation:

…

2.   The measures referred to in paragraph 1 shall be appropriate to the nature and gravity of the infringement and shall include provisions relating to the seizure and, where appropriate, confiscation of specimens.’

11

Annex B to that regulation lists the ‘Hippocampus spp. (II)’.

12

Recitals 1, 2 and 6 of Commission Regulation (EC) No 865/2006 of 4 May 2006 laying down detailed rules concerning the implementation of Council Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein (OJ 2006 L 166, p. 1), as amended by Commission Regulation (EC) No 100/2008 of 4 February 2008 (OJ 2008 L 31, p. 3) (‘Regulation No 865/2006’), state:

…

13

Article 1 of Regulation No 865/2006, entitled ‘Definitions’, provides in point 5 thereof:

‘For the purposes of this Regulation, in addition to the definitions laid down in Article 2 of Regulation [No 338/97], the following definitions shall apply:

…

14

Article 57 of that regulation, entitled ‘Introduction and reintroduction into the Community of personal and household effects’, states:

‘1.   The derogation from Article 4 of Regulation [No 338/97] for personal or household effects, provided for in Article 7(3) of that Regulation, shall not apply to specimens used for commercial gain, sold, displayed for commercial purposes, kept for sale, offered for sale or transported for sale.

That derogation shall only apply to specimens, including hunting trophies, if they meet one of the following conditions:

…

3.   The first introduction into the Community of personal or household effects, including hunting trophies, by a person normally residing in the Community and involving specimens of species listed in Annex B to Regulation [No 338/97] shall not require the presentation to customs of an import permit, provided that the original of a (re-)export document and a copy thereof are presented.

…

5.   By way of derogation from paragraphs 3 and 4, the introduction or re-introduction into the Community of the following items listed in Annex B to Regulation [No 338/97] shall not require the presentation of a (re-)export document or an import permit:

…

…’

15

Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 (OJ 2022 L 118, p. 4) (‘Directive 2001/83’), provided:

‘For the purposes of this Directive, the following terms shall bear the following meanings:

…

Medicinal product:

16

Article 128(1) of the ustawa o ochronie przyrody (Law on Nature Protection) of 16 April 2004 (Dz. U. No 92, item 880), in the version applicable to the dispute in the main proceedings (‘the Law on Nature Protection’), provides:

‘Any person who transports across the border of the European Union, without the document required … or in breach of the terms [provided for], a specimen of a species protected … shall be liable to a custodial sentence of between three months and five years.’

17

On 16 April 2024, V.B., a Ukrainian national, introduced into Poland, without an import permit, four boxes, each containing 100 tablets, of a preparation containing extract of Japanese seahorse (‘the preparation at issue in the main proceedings’), which he had purchased in Ukraine for his personal use.

18

The Sąd Rejonowy w Jarosławiu Wydział II Karny (District Court (Second Criminal Division), Jarosław, Poland), which is the referring court, received an indictment initiating proceedings, approved by the Prokurator Prokuratury Rejonowej w Jarosławiu (Prosecutor from the District Prosecutor’s Office, Jarosław, Poland), against V.B., alleging that the facts described in paragraph 17 above constitute a criminal offence under Article 128(1) of the Law on Nature Protection, punishable by a custodial sentence of between three months and five years.

19

The referring court considers that the question whether the introduction into the European Union, without an import permit, of the boxes of tablets containing the preparation at issue in the main proceedings is a punishable offence, in the light of Article 128(1) of the Law on Nature Conservation, depends in particular on the interpretation of Regulation No 338/97.

20

In that regard, it seeks to ascertain, in the first place, whether such a preparation, in so far as it contains extract of Japanese seahorse, is to be regarded as coming within the concept of ‘specimen’, within the meaning of Article 2(t) of that regulation. It states that that preparation satisfies the conditions for being classified as a medicinal product and seeks to ascertain, in particular, whether such a classification would affect the interpretation of that concept of ‘specimen’.

21

In the second place, the referring court observes that V.B. purchased the preparation at issue in the main proceedings as a private individual in a pharmacy in Ukraine, where it is legally available for sale, and introduced it into the European Union for his own therapeutic needs or for those of a close relative, and not for commercial purposes. That court asks whether, in such circumstances, that preparation must be regarded as being part of the accused’s ‘personal or household effects’, within the meaning of Article 2(j) of Regulation No 338/97, which are, under Article 7(3) of that regulation, not subject to the obligation to present an import permit when they are introduced into the European Union.

22

In the third and last place, the referring court seeks to ascertain whether EU law precludes national legislation which permits the criminal prosecution of a consumer who introduces into the European Union, without an import permit, for his or her own therapeutic needs or those of a close relative, a preparation such as that at issue in the main proceedings, lawfully purchased in a third country, in the absence of any indication that that preparation was intended for commercial use.

23

In those circumstances, the Sąd Rejonowy w Jarosławiu (District Court, Jarosław) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

24

By its first question, the referring court asks, in essence, whether Article 2(t) of Regulation No 338/97 must be interpreted as meaning that the concept of ‘specimen’, within the meaning of that provision, covers a preparation the complex composition of which contains inter alia extract of Japanese seahorse, a species included in Annex B to that regulation.

25

According to settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgments of 17 November 1983, Merck, 292/82, EU:C:1983:335, paragraph 12, and of 2 July 2020, Magistrat der Stadt Wien (European hamster), C‑477/19, EU:C:2020:517, paragraph 23 and the case-law cited).

26

As regards the wording of Article 2(t) of Regulation No 338/97, it should be noted that that provision defines the term ‘specimen’ broadly, as covering not only any animal or plant, whether alive or dead, but also ‘any part or derivative’ of species listed in Annexes A to D thereof, ‘whether or not contained in other goods’, as well as ‘any other goods’ when it is apparent from their label, packaging or mark, from any other accompanying document, or from any other circumstances that those goods contain parts or derivatives of animals or plants belonging to those species, unless those parts or derivatives are subject to a specific exemption from the application of that regulation.

27

Consequently, it must be held that, in principle, any product derived from a protected species and any goods containing such a product come within the concept of ‘specimen’, within the meaning of Article 2(t) of Regulation No 338/97.

28

That interpretation is supported by the context surrounding that concept and by the objective pursued by Regulation No 338/97. In that regard, it should be borne in mind that, under the first subparagraph of Article 4(2) of that regulation, the introduction into the European Union of specimens of the species listed in Annex B to that regulation is to be subject to completion of the necessary checks and the prior presentation, at the border customs office at the point of introduction, of an import permit issued by a management authority of the Member State of destination. Furthermore, the issuance of such an import permit is subject to a number of conditions and restrictions, pursuant to points (a) to (c) of the second subparagraph of Article 4(2) of that regulation and to Article 4(6) thereof.

29

A restrictive interpretation of the concept of ‘specimen’ as excluding certain processed products or derivatives containing extracts of a protected animal or plant would result in their not being subject to the obligation to present an import permit when they are introduced into the European Union and thus in their being exempted from the controls on their trade established by Regulation No 338/97, whereas the objective of that regulation, as is apparent from Article 1 thereof, is to protect species of wild fauna and flora and to guarantee their conservation by regulating trade therein. Such an interpretation would therefore risk undermining the protection and conservation of those species.

30

In the present case, it is apparent from the order for reference that the preparation at issue in the main proceedings is a complex composition containing, among other components, extract of Japanese seahorse, an animal belonging to the family Syngnathidae and the genus Hippocampus.

31

All species of Syngnathidae belonging to the genus Hippocampus are listed in Annex B to Regulation No 338/97, with the result that the Japanese seahorse Hippocampus japonicus is a species subject to the protection provided for species listed in Annex B to that regulation.

32

It should also be noted that that species is not subject to any specific exemption from the application of the provisions of Regulation No 338/97.

33

In those circumstances it must be concluded that a preparation the complex composition of which contains, inter alia, extract of Japanese seahorse comes within the concept of ‘specimen’ within the meaning of Article 2(t) of Regulation No 338/97.

34

In so far as the referring court asks, in addition, whether classifying that preparation as a ‘medicinal product’, within the meaning of point 2 of Article 1 of Directive 2001/83, is likely to affect its classification as a ‘specimen’, within the meaning of Article 2(t) of Regulation No 338/97, it must be noted that, first, the wording of the latter provision makes no distinction based on the use or intended purpose of the goods or products derived from protected species.

35

Second, no provision of Regulation No 338/97 permits the inference that medicinal products are excluded from the scope thereof.

36

It follows that the classification of a product as a ‘medicinal product’, within the meaning of point 2 of Article 1 of Directive 2001/83, does not affect the interpretation of the concept of ‘specimen’, within the meaning of Article 2(t) of Regulation No 338/97.

37

In the light of all the foregoing considerations, the answer to the first question is that Article 2(t) of Regulation No 338/97 must be interpreted as meaning that the concept of ‘specimen’, within the meaning of that provision, covers a preparation the complex composition of which contains inter alia extract of Japanese seahorse, a species included in Annex B to that regulation.

38

It should be noted as a preliminary point that, according to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to decide the case before it. To that end, the Court should, where necessary, reformulate the questions referred to it. The Court may also find it necessary to consider provisions of EU law which the national court has not referred to in its questions (judgments of 20 March 1986, Tissier, 35/85, EU:C:1986:143, paragraph 9, and of 5 December 2019, Centraal Justitieel Incassobureau (Recognition and enforcement of financial penalties), C‑671/18, EU:C:2019:1054, paragraph 26 and the case-law cited).

39

The fact that the referring court has formally referred, in its questions, to certain specific provisions of EU law does not prevent the Court from providing it with all the elements of interpretation which may be useful for the judgment in the main proceedings, by extracting from the body of material provided by that court, and in particular from the statement of reasons for the order for reference, the elements of EU law which require interpretation in the light of the subject matter of the dispute (see judgments of 29 November 1978, Redmond, 83/78, EU:C:1978:214, paragraph 26, and of 22 January 2026, Secab, C‑423/23, EU:C:2026:32, paragraph 29).

40

In that regard, it should be noted that Article 7(3) of Regulation No 338/97, mentioned by the referring court in its third question, which must be examined in the second place, refers to the provisions specified by the Commission for the purpose of establishing rules for the implementation of that regulation. Therefore, in order to answer that question, account should be taken of Article 57 of Regulation No 865/2006, which governs the conditions for introduction and reintroduction of personal or household effects into the European Union.

41

It must therefore be held that, by its third question, the referring court asks, in essence, whether Article 2(j) and Article 7(3) of Regulation No 338/97, read in conjunction with Article 57 of Regulation No 865/2006, must be interpreted as meaning that a preparation the complex composition of which contains extract of Japanese seahorse – a species included in Annex B to Regulation No 338/97 – lawfully purchased in a third country and introduced into the European Union for the therapeutic needs of a private individual or those of a close relative, and not for commercial purposes, must be regarded as coming within the concept of ‘personal or household effects’, the introduction of which into the European Union is not subject to the obligation to present an import permit or, where applicable, a (re-)export document.

42

As stated in paragraph 28 above, under the first subparagraph of Article 4(2) of Regulation No 338/97, the introduction into the European Union of specimens of the species listed in Annex B to that regulation is subject, inter alia, to the prior presentation, at the border customs office at the point of introduction, of an import permit issued by a management authority of the Member State of destination.

43

However, by way of derogation from Article 4 of Regulation No 338/97, Article 7(3) thereof provides that the obligation to present an import permit does not apply to dead specimens, parts and derivatives of species listed in Annexes A to D thereto which are personal or household effects being introduced into the European Union, or exported or re-exported therefrom, in compliance with provisions laying down rules for the implementation of that regulation that are to be specified by the Commission.

44

According to the definition laid down in Article 2(j) of Regulation No 338/97, dead specimens, parts and derivatives thereof that are the belongings of a private individual and that form, or are intended to form, part of his or her normal goods and chattels come within the concept of ‘personal or household effects’.

45

Thus, it must be observed that the wording of that provision does not make it possible to determine unequivocally whether the applicability of the concept of ‘personal or household effects’ necessarily requires use or consumption, by the importer himself or herself, of those dead specimens, parts of specimens or products derived therefrom (judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 28).

46

It is conceivable that such items, held or possessed personally, may subsequently be transferred free of charge by the importer to a third party as a gift, instead of being retained by the importer for strictly individual use (see, to that effect, judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 29).

47

In the present case, for reasons similar to those set out in paragraphs 25 to 33 above, if a preparation such as that at issue in the main proceedings contains, in its complex composition, extract of Japanese seahorse, it must be regarded as being a derivative of dead specimens or parts thereof for the purposes of Article 2(j) of Regulation No 338/97.

48

As follows from Article 7(3) of that regulation, in order to come within the derogation for personal or household effects referred to in that provision, the introduction into the European Union of such a product must satisfy the conditions laid down in Regulation No 865/2006.

49

In that regard, first, it should be noted that the first subparagraph of Article 57(1) of Regulation No 865/2006 specifies that the derogation does not apply to specimens that are used for commercial gain, sold, displayed for commercial purposes, kept for sale, offered for sale or transported for sale.

50

In addition, it is clear from recital 1 thereof that that regulation is intended to implement Regulation No 338/97 and ensure full compliance with CITES. Resolution 13.7 of the Conference of the Parties to CITES, which helps to clarify the interpretation of the provisions of that convention, specifies, in paragraph 1 thereof, that the concept of ‘personal or household effects’ applies to specimens that are held or possessed in a personal capacity, for non-commercial purposes, have been legally acquired and are carried, transported or included in personal luggage or are part of a removal (judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 31).

51

The Court has thus found that it is clear both from the wording of Article 57(1) of Regulation No 865/2006 and from that of Resolution 13.7 of the Conference of the Parties to CITES, that the absence of a commercial purpose for the imported specimen constitutes a decisive criterion for the purposes of its classification as ‘personal or household effects’, an interpretation which is also supported by the objectives pursued by Regulation No 338/97 (judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 33).

52

It follows that the introduction into the European Union of a preparation containing derivatives of dead specimens or parts thereof, for a private individual’s therapeutic needs or for those of a close relative, and not for commercial purposes, is liable to come within the derogation applicable to ‘personal or household effects’ set out in Article 7(3) of Regulation No 338/97, provided that the other conditions for its application, laid down in Article 57 of Regulation No 865/2006, are satisfied.

53

In that regard, the second subparagraph of Article 57(1) of Regulation No 865/2006 provides that that derogation is to apply only to specimens which are contained in the personal luggage of travellers coming from a third country or which are contained in the personal property of a natural person transferring his or her normal place of residence from a third country to the European Union or which are hunting trophies.

54

It will be for the referring court, which alone has jurisdiction to establish the facts in the main proceedings, to ascertain whether any of those conditions is satisfied, in order to determine whether that derogation applies in the case in the main proceedings.

55

Second, Article 57(3) of Regulation No 865/2006 specifies, for its part, that the first introduction into the European Union of specimens of species listed in Annex B to Regulation No 338/97 which constitute personal or household effects by a person normally residing in the European Union does not require the presentation to customs of an import permit, provided that the original of a (re-)export document and a copy thereof are presented.

56

In this respect, point 5 of Article 1 of Regulation No 865/2006 defines ‘a person normally residing in the [Union]’ as a person who lives in the Union for at least 185 days in each calendar year because of occupational ties, or, in the case of a person with no occupational ties, because of personal ties which show close links between that person and the place where he or she is living.

57

In the present case, the order for reference does not specify whether V.B. is a person normally residing in the European Union, within the meaning of point 5 of Article 1. It will therefore be for the referring court to ascertain whether that is the case. If so, the introduction into the European Union by such person of a preparation such as the one at issue in the main proceedings must, in principle, be accompanied by the original of a (re-)export document and a copy thereof.

58

In that regard, it should be pointed out that, by way of derogation to Article 57(3) of Regulation No 865/2006, there is no requirement to present such a (re-)export document for the introduction into the European Union of up to four dead specimens of Japanese seahorse per person, in accordance with Article 57(5)(e) of that regulation.

59

Without prejudice to the verification that it will be for the referring court to carry out, the preparation at issue in the main proceedings does not appear to come within the scope of the derogation provided for in Article 57(5)(e) of Regulation No 865/2006.

60

In so far as it constitutes a derogation from the obligation to present a (re-)export document imposed on any person normally residing in the European Union, Article 57(5)(e) of Regulation No 865/2006 must be interpreted strictly (judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 43) as meaning that it applies solely to ‘dead specimens’ and within the limits of the quantities stated above.

61

It is apparent from the order for reference that the preparation at issue in the main proceedings is not a ‘dead specimen’ within the meaning of Article 57(5)(e) of Regulation No 865/2006, but consists of tablets the complex composition of which contains extract of Japanese seahorse.

62

To accept that Article 57(5)(e) of Regulation No 865/2006 can also cover products the complex composition of which contains an extract from a dead specimen would not only go beyond the wording of that provision, thereby running counter to its strict interpretation, but would also give rise to difficulties of interpretation and application, in that it could prove excessively difficult, if not impossible, to determine accurately whether, in such a complex product, the proportional amount obtained from such a species corresponds to the limit of ‘four dead specimens’ per person. Such an interpretation, moreover, would disregard the objective, set out in recital 12 of Regulation No 338/97 and in recitals 2 and 6 of Regulation No 865/2006, of facilitating customs procedures and ensuring effective controls (see, to that effect, judgment of 12 May 2021, Hauptzollamt B (Sturgeon caviar), C‑87/20, EU:C:2021:382, paragraph 46).

63

By contrast, if the referring court were to find that V.B. is not a person normally residing in the European Union, within the meaning of point 5 of Article 1 of Regulation No 865/2006, it would be sufficient, in order for the derogation provided for in Article 7(3) of Regulation No 338/97 to apply in the case in the main proceedings, for any of the conditions provided for in Article 57(1) of Regulation No 865/2006, referred to in paragraph 53 above, to be satisfied, which it is for the referring court to ascertain.

64

That said, it should be noted that the Czech, Austrian and Polish Governments maintain that there is a risk of illegal trade in protected species which are introduced into the European Union as ‘personal or household effects’ and as a result are not subject to the obligation to present an import permit, whereas in fact they are not ‘personal or household effects’ but belong to a network of coordinated unlawful imports of small quantities of such specimens for commercial purposes.

65

In that regard, it should be borne in mind, as stated in paragraph 51 above, that the absence of a commercial purpose for the introduction into the European Union of the imported specimen constitutes a decisive criterion for the purposes of its classification as ‘personal or household effects’, within the meaning of Article 7(3) of Regulation No 338/97 and of Article 57 of Regulation No 865/2006. Consequently, there is nothing to prevent the competent national authorities from demonstrating that, despite appearances, the introduction into the European Union of the specimen concerned does in fact pursue a commercial purpose, with the result that the derogation provided for in Article 7(3) of Regulation No 338/97 and in Article 57 of Regulation No 865/2006 would not apply to such introduction.

66

However, the question whether that criterion is met in a specific case is a point of fact which, as such, comes within the exclusive jurisdiction of the national court. In the present case, it appears from the order for reference that there is nothing to indicate that the introduction into the European Union by V.B. of the preparation at issue in the main proceedings had a commercial purpose.

67

In the light of all the foregoing considerations, the answer to the third question is that Article 2(j) and Article 7(3) of Regulation No 338/97 must be interpreted as meaning that a preparation the complex composition of which contains extract of Japanese seahorse – a species included in Annex B to that regulation – lawfully purchased in a third country and introduced into the European Union for the therapeutic needs of a private individual or for those of a close relative, and not for commercial purposes, must be regarded as coming within the concept of ‘personal or household effects’, the introduction of which into the European Union is not subject to the obligation to present an import permit or, where applicable, a (re-)export document, provided that the conditions laid down for that purpose in Article 57(1) and (3) of Regulation No 865/2006 are satisfied.

68

In accordance with the case-law cited in paragraphs 38 and 39 above, in the context of the second question, which must be examined in the third place and which seeks to ascertain whether criminal sanctions can be imposed for unlawfully importing specimens of protected species of wild fauna and flora, account must be taken of Article 16 of Regulation No 338/97, which governs the sanctions that may be imposed for infringements of that regulation.

69

Therefore, it must be held that, by its second question, the referring court asks, in essence, whether Article 16 of Regulation No 338/97 must be interpreted as precluding national legislation which provides for the imposition of criminal sanctions for the introduction into the European Union, without an import permit or, where applicable, without a (re-)export document, of a preparation lawfully purchased in a third country, the complex composition of which contains extract of Japanese seahorse – a species included in Annex B to that regulation – by a private individual, for his or her own therapeutic needs or for those of a close relative and not for commercial purposes.

70

Article 16 of Regulation No 338/97, entitled ‘Sanctions’, provides in paragraph 1 thereof that Member States are to take appropriate measures to ensure the imposition of sanctions for at least certain infringements of that regulation. In respect of those infringements, point (a) of that provision concerns the introduction into the European Union of specimens without the appropriate permit or certificate or with a false, falsified or invalid permit or certificate or one altered without authorisation by the issuing authority.

71

In accordance with paragraph 2 of that article, the measures referred to in paragraph 1 are to be appropriate to the nature and gravity of the infringement and include provisions relating to the seizure and, where appropriate, confiscation of specimens. Neither that article nor any other provision of that regulation provides any clarification concerning the criminal or administrative classification of those sanctions.

72

It follows that Regulation No 338/97 does not prevent the Member States from imposing criminal sanctions for such an infringement, provided that they are appropriate to the nature and gravity of that infringement.

73

In the present case, if the referring court were to conclude that the derogation provided for in Article 7(3) of Regulation No 338/97, as set out in more detail in Article 57 of Regulation No 865/2006, is applicable in the case in the main proceedings, the introduction into the European Union of the specimen concerned could not then be regarded as an infringement of the provisions of Regulation No 338/97, within the meaning of Article 16 thereof. In that scenario, Article 16 of Regulation No 338/97 would preclude national legislation imposing a sanction, irrespective of its nature, for such introduction into the European Union.

74

By contrast, if the referring court were to conclude that the derogation provided for in Article 7(3) of Regulation No 338/97, as set out in more detail in Article 57 of Regulation No 865/2006, does not apply in the case in the main proceedings, the introduction into the European Union of the preparation at issue in the main proceedings without an import permit or, where applicable, without a (re-)export document, within the meaning of Article 57(3) of Regulation No 865/2006, would constitute an infringement of the provisions of Regulation No 338/97.

75

In such a case, that court would then have to determine whether the criminal sanction consisting in a custodial sentence of between three months and five years is appropriate to the nature and gravity of that infringement, in accordance with Article 16(2) of Regulation No 338/97.

76

Accordingly, that court will have to take into account all the relevant circumstances of the case, such as, in particular, whether the infringement in question was committed intentionally or as a result of negligence, the quantities of the specimens which form the subject matter of the infringement and the personal circumstances of the accused, and must exercise the full discretion the national law affords it for the purpose of imposing a criminal sanction which is in line with the proportionality requirements relating to Article 16(2) of Regulation No 338/97, and in particular by making use, where appropriate, of sentence adjustment and enforcement measures provided for by national law.

77

In the light of all the foregoing considerations, the answer to the second question is that Article 16 of Regulation No 338/97 must be interpreted as precluding national legislation which provides for the imposition of criminal sanctions for the introduction into the European Union, without an import permit or, where applicable, without a (re-)export document, of a preparation lawfully purchased in a third country, the complex composition of which contains extract of Japanese seahorse – a species included in Annex B to Regulation No 338/97 – by a private individual, for his or her own therapeutic needs or for those of a close relative and not for commercial purposes, even though that introduction comes within the derogation provided for in Article 7(3) of Regulation No 338/97 and set out in further detail in Article 57 of Regulation No 865/2006. By contrast, it does not preclude such national legislation where the introduction into the European Union of such a preparation does not come under that derogation, provided that the applicable criminal sanction complies with the proportionality requirements inherent to Article 16(2) of that regulation.

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Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring 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 (Ninth Chamber) hereby rules: