Background
On 16 April 2024, V.B., a Ukrainian national, crossed into Poland carrying four boxes of 100 tablets each—a preparation whose complex composition included extract of Japanese seahorse (Hippocampus spp.). He had bought the tablets at a Ukrainian pharmacy for personal or close-relative therapeutic use and carried no EU import permit. All Hippocampus species are listed in Annex B to Council Regulation (EC) No 338/97 (the EU’s CITES implementation regulation), which generally requires an import permit before such specimens may enter the European Union. Polish law makes cross-border transport of protected species without the required documentation a criminal offence punishable by three months to five years’ imprisonment.
The District Court (Second Criminal Division) in Jarosław, facing V.B.’s indictment, stayed the proceedings and referred three questions to the Court of Justice. The core issues were: (1) whether processed tablets containing seahorse extract fall within the statutory concept of “specimen”; (2) whether the tablets could instead qualify as “personal or household effects” exempt from the permit requirement; and (3) whether EU law bars criminal prosecution of a consumer who imports such a product for personal medical use without any commercial intent.
Several Member States—Poland, the Czech Republic, Germany, and Austria—together with the European Commission submitted observations. The Court decided to proceed to judgment without an Advocate General’s Opinion.
The Court’s Holding
On the first question, the Court held that the concept of “specimen” in Article 2(t) of Regulation No 338/97 is deliberately broad, covering “any part or derivative” of a listed species “whether or not contained in other goods,” as well as any goods whose packaging or labelling indicates the presence of such parts or derivatives. A tablet preparation whose complex composition includes extract of Japanese seahorse therefore qualifies as a “specimen.” The Court also held that a product’s classification as a “medicinal product” under Directive 2001/83/EC is irrelevant to this assessment: Regulation No 338/97 draws no distinction based on the intended use of derived goods, and no provision excludes medicinal products from its scope. A restrictive reading that carved out processed derivatives would hollow out the conservation objective the regulation is designed to serve.
On the third question (examined second), the Court held that the “personal or household effects” derogation in Article 7(3) of Regulation No 338/97, read with Article 57 of Commission Regulation (EC) No 865/2006, can in principle cover such a preparation when it is imported for private therapeutic purposes without any commercial intent—the absence of a commercial purpose being the decisive criterion. However, additional conditions in Article 57(1) must also be satisfied (the goods must, for example, be in the traveller’s personal luggage). Whether those conditions are met is a question of fact for the referring court alone. The Court further held that the lighter derogation in Article 57(5)(e) of Regulation No 865/2006—which exempts up to four dead Hippocampus specimens from the requirement to present a re-export document—does not extend to complex preparations containing seahorse extract: that provision must be interpreted strictly as applying only to intact dead specimens, and extending it to composite products would make it practically impossible to verify compliance with the four-specimen limit.
The Court left resolution of V.B.’s case to the national court, directing it to ascertain whether V.B. normally resides in the EU (which determines whether a re-export document is required in addition to an import permit), and whether the personal-luggage or household-move conditions of Article 57(1) are satisfied. It also confirmed that national authorities remain free to demonstrate, on the facts, that an ostensibly personal import actually pursues a commercial purpose, in which case the derogation would not apply.
Key Takeaways
- Any preparation or processed product containing extract of a CITES Annex B species is a “specimen” under Regulation No 338/97 and requires an import permit at the EU border—its classification as a medicinal product, food supplement, or other regulated category makes no difference.
- The “personal or household effects” exemption can shield a non-commercial, therapeutic import of such a preparation from the permit obligation, but only when all conditions of Article 57 of Regulation No 865/2006 are concretely satisfied; the burden is on the facts of each case.
- The simplified derogation for up to four dead Hippocampus specimens (Article 57(5)(e) of Regulation No 865/2006) does not apply to tablets or other complex preparations—it is limited to intact dead specimens and must be interpreted strictly.
- Member States remain entitled to criminal sanctions for unpermitted imports, but courts must first determine whether the personal-effects exemption applies before imposing liability on a private consumer with no evident commercial purpose.
Why It Matters
This ruling closes a potential gap in EU wildlife-trade enforcement by confirming that processing a protected species into tablets, capsules, or other derived preparations does not allow the product to slip past CITES controls at EU borders. Traders and travellers who carry traditional medicines or health supplements containing listed-species extracts cannot rely on the product’s pharmaceutical packaging or foreign pharmacy receipt to avoid EU import requirements. The decision aligns the EU regime with the broad conservation purpose of CITES and with the Court’s earlier reasoning in Hauptzollamt B (Sturgeon caviar) (C-87/20).
At the same time, the Court preserves meaningful space for genuine personal-use imports. A traveller carrying a small quantity of such a preparation solely for personal or family medical needs, with no commercial dimension, may still invoke the personal-effects derogation—provided the precise documentary and factual conditions of Article 57 of Regulation No 865/2006 are met. The judgment thus requires national prosecutors and courts to conduct a careful, fact-specific inquiry before treating an ordinary consumer as a wildlife trafficker, while making clear that authorities may look behind the “personal use” label when coordinated small-scale imports suggest a commercial scheme.