ECJ on On-Hold Botanical Claims – EU Law Applies

Overview

The European Court of Justice (ECJ), in its judgment C-386/23 of April 30, 2025, clarified that "on-hold claims" for botanical substances in food stuff may only be used if they comply with the requirements of the Health Claims Regulation (EC) No. 1924/2006 ("HCR") and the transitional provisions of Article 28.

Facts of the Case

A company advertised food supplements containing botanical ingredients using so-called "on-hold“ claims—health claims that are still under review by the European Commission. The product was notified and (otherwise) lawfully placed on the market in a Member State. The core question was whether the chosen claims could be used while awaiting a final assessment by EFSA and a decision on their validity by the EU Commission.

Court Decision

The ECJ ruled that the use of "on-hold claims" for botanical substances in food stuff is permissible, provided that they comply with the general requirements of the HCR, particularly the obligation for scientific substantiation and the avoidance of misleading information. National authorities cannot prohibit such claims as long as these conditions are met. However, the "on-hold“ claims must also comply with the transitional provisions of the HCR. The decisive factor is, a.o., whether the respective claims were the subject of a "timely" application under the HCR (before January 19, 2008) by a Member State for evaluation by EFSA and the EU Commission. National lists of "on-hold“ claims or positive national authorization procedures for products do not justify their use.

Conclusion

The judgment calrifies that "on-hold“ claims are not automatically permissible but are subject to the requirements of the HCR. Companies must ensure that their advertising statements for botanicals are scientifically substantiated, do not mislead consumers, and that the claims are covered by the transitional provisions of the HCR. It is advisable, for instance, to verify whether and when an application for the evaluation of a specific claim was submitted by a Member State.