The CJEU clarifies use of health claims on botanicals

On 30 April 2025, the Court of Justice of the European Union (CJEU) delivered a judgment in case C‑386/23, on the use of health claims relating to botanical substances under Regulation 1924/2006.

Background
According to Article 10 of Regulation 1924/2006, the use of health claims is permitted only if such claims were authorised by the European Commission. In 2010, the European Commission suspended the evaluation of health claims related to botanical substances mainly due to the absence of human intervention studies. The suspension led to a backlog of over 2000 applications pending assessment. Subsequently, in 2012, the European Commission created an "on-hold" list of pending health claims and allowed their use in the EU under the transitional provisions from Article 28(5) of Regulation 1924/200, until a final assessment.

Case
The German company Novel Nutriology GmbH advertised a food supplement containing saffron and melon juice extracts, with health claims indicating that the product could improve mood and reduce fatigue and stress due to the presence of these botanicals. A German association, the Verband Sozialer Wettbewerb eV (VSW), challenged the legality of these claims before the German courts, arguing they violated Article 10 of Regulation 1924/2006, as the claims were not authorised at EU level.

The referring court asked for clarification as to whether Articles 10(1) and (3) of Regulation 1924/2006 apply to health claims relating to botanicals, in view of the suspension of the European Commission’s evaluation of botanical claims. The referring court wonders whether this suspension could have any legal effect, since:

1. Firstly, that suspension could effectively prevent companies from obtaining specific authorized health claims for botanical substances. As a result, companies are not submitting new health claim applications, as it is unlikely that new applications will be evaluated in the near future. Therefore, companies cannot use new botanical health claims in advertising of their products.
    
2. Secondly, the European Commission's prolonged suspension may constitute a disproportionate restriction on the freedom to conduct a business, enriched in Article 16 of the Charter of Fundamental Rights of the European Union. Companies marketing botanicals face uncertainty and potential competitive disadvantages, as they cannot obtain new authorizations for botanical health claims. This limits their advertising opportunities for their products containing botanicals.
    
3. Finally, this situation could also lead to an unjustified difference in treatment of companies marketing botanical substances who cannot get new health claims authorization, compared to the companies whose health claims applications were evaluated and authorised and who can use them in their advertising.

Reasoning of the CJEU

1. The CEJU reminded that under Regulation 1924/2006, it is not allowed to use health claims without them being authorized by the European Commission. The fact that the European Commission suspended the evaluation of botanical claims does not change this, because the Regulation foresees a transitional regime under Article 28 which allows the use of health claims on botanicals for which an application was submitted before 19 January 2008 (pending health claims from the “on hold” list). In other words, companies are not effectively prevented from using health claims for botanical substances.
    
2. Furthermore, the prohibition of using unauthorized health claims does not disproportionately restrict the freedom to conduct a business. According to the CJEU, this prohibition does not prevent companies from placing foods containing botanicals on the EU market, but it only prohibits their advertising with unauthorised and unassessed health claims.
    
3. Finally, the CJEU held that the treatment of botanical health claims is justified and proportionate to the aim pursued. By requiring that all health claims are scientifically verified, a high level of consumer and health protection is ensured. Furthermore, all health claims, including those relating to botanicals, must undergo the same assessment procedure to ensure they are scientifically verified.

Consequently, the CJEU held that all food business operators must comply with the provisions from Regulation 1924/2006 which remain unchanged.

FCI comment
In this judgment, the CJEU sought to balance the freedom to conduct a business with the objectives of public health and consumer protection. The judgment also emphasizes the importance of the EU fundamental principles of proportionality, which ensures that measures are necessary and appropriate and legal certainty, which ensures clear and predictable rules. While consumer and health protection are the overriding aims, restrictions on companies’ economic activity must be proportionate to the aim pursued. In addition, the transitional measures help companies operate in the current regulatory framework.

While the suspension of the European Commission’s evaluation process for botanical health claims creates confusion and difficulties for companies on the EU market, the CJEU highlighted that this does not change the validity of the requirement from Regulation 1924/2006 that health claims must be authorized to be used. This decision aligns with the CJEU’s judgment from 2020 in Case T-620/14 (available here), where it held that the failure to act by the European Commission in evaluating health claims for botanical substances does not allow companies to use unauthorized claims.

Following this judgment, the options for companies who wish to advertise their products with botanical health claims remain limited. Firstly, companies may use authorized health claims. However, currently there are very few authorized health claims relating to botanical substances. Secondly, there is a possibility of using pending health claims for botanicals from the “on hold” list which comprises over 2000 botanical health claims. However, pending health claims can only be used provided the company can scientifically substantiate them. Finally, companies may apply for new health claims authorizations, which must undergo the full evaluation process and be authorized before they can be used, as provided by Regulation 1924/2006.

The full judgment is available  here.