Food Supplements (Botanicals), Health Claims and Advertising: Beware of Prohibited Information

The general prohibition of such information was pronounced by the Court of Justice on 30 April 2025 and it applies until the Commission has completed its examination of those claims and has included them in the lists of authorised health claims, unless their use is already permitted under a transitional regime.

The Court so decided in case C-386/23 for a preliminary ruling brought by the Bundesgerichtshof on Regulation (EC) No. 1924/2006 (the ‘Regulation’) on nutrition and health claims made on foodstuffs.

The reference for a preliminary ruling concerns consumer protection, in particular on the interpretation of the provisions on the specific conditions for health claims (Article 10, paragraphs 1 and 3 in conjunction with Articles 13 and 14), and on the lists of permitted health claims relating to botanical substances which have remained unfinished by the European Commission.

The facts of the reference for a preliminary ruling were set out in the context of a dispute between Novel Nutriology GmbH and Verband Sozialer Wettbewerb eV (‘VSW’) concerning the commercial advertising, carried out by Novel Nutriology, using the following claims relating to the ‘saffron extract’ and the ‘melon juice extract’ contained in that product:

1. Mood-enhancing saffron extract.

2. The saffron extract Safr’Inside in [the product concerned] was tested on 50 participants over a period of 30 days in an open study. With a dose of 30 mg of Safr’Inside per day, 77% of the subjects experienced an improvement in emotional balance, felt more optimistic and happier after only 2 weeks of use. 66% also felt more relaxed and dynamic. After 30 days, sleep quality improved in 11% of the subjects.

3. Melon juice extract with superoxide dismutase activity has been shown in studies to reduce feelings of stress and fatigue after four weeks. It also reduced irritability and fatigue by 63%, leading to a significant improvement in quality of life.’

VSW, a trade association that defends the commercial interests of its members, taking the view that such indications are prohibited by Article 10 of the Regulation, brought an action aimed at prohibiting Novel Nutriology from advertising the food supplement in question using the abovementioned health claims.

Following the upholding of that action by the court of first instance, Novel Nutriology brought an appeal. The latter having been dismissed, Novel Nutriology brought an appeal on a point of law before the referring court.

Consequently, the referring court question whether Article 10(1) and (3) of the Regulation is applicable to health claims relating to botanical substances, given that neither the European Food Safety Authority (EFSA) nor the Commission have completed the examination of those claims for the purposes of their possible inclusion in the lists of permitted health claims.

In the first place, the Court points out that Article 10(1) of the Regulation lays down a prohibition in principle on health claims, with the exception of those appearing on the lists of authorised claims. It also states that Article 10 of same Regulation distinguishes between two categories of health claims, namely, on the one hand, the specific health claim[1] and, on the other hand, the 'general' health claim[2] which refers to general beneficial effects on the general state of health. Consequently, the use of a specific health claim is only permitted if it is included in the lists of permitted health claims, whereas any general health claim must be accompanied by such a specific claim.

In the second place, the Court states that the inclusion of specific health claims on the lists of authorised claims is subject to various authorisation procedures intended, inter alia, to ensure that those claims are scientifically justified. In particular, as to, health claims describing or mentioning psychological or behavioural functions, such as those at issue in the main proceedings, the Court states that the use of such claims is permitted by the Regulation[3] provided that they are based on generally accepted scientific evidence and are well understood by the average consumer.

In the third place, the Court finds that, according to Article 13 of the Regulation[4], the Commission was required to consult EFSA with a view to adopting, by 31 January 2010 at the latest, the list of authorised health claims referred to in that article. However, the assessment of health claims for botanicals has been suspended and the list of such claims has not yet been established. According to Regulation No 536/2013[5], health claims whose examination has not been completed may continue to be used, pursuant to the transitional measures provided for in Article 28 of the Regulation.

However, in the present case, one of the two claims at issue was the subject of a late application, while no application was made for the other claim. In that context, recourse to the claims at issue in the main proceedings cannot be authorised under the transitional arrangements provided for in Article 28 of the Regulation. In so far as recourse to those claims can take place only under Article 10 of the regulation, it cannot be authorised as long as the Commission has not completed its examination of those allegations.

In the light of all the foregoing considerations, the Court concludes that

Article 10(1) and (3) of the Regulation precludes authorisation, in the context of commercial advertising of a food supplement composed of botanical substances, as long as the Commission has not completed the examination of health claims relating to botanical substances for the purposes of their inclusion in the lists of authorised health claims, use specific health claims relating to such substances and describing or mentioning psychological or behavioural functions. The same applies to references to the general non-specific beneficial effects of such a substance on general health and health-related well-being, if that reference is not accompanied by a specific health claim on those lists. The use of specific health claims relating to botanical substances is, however, possible if it is authorised under Article 28(6) of that Regulation.

[1] Article 10(1) of Regulation No 1924/2006.

[2] Article 10(3) of Regulation No 1924/2006

[3] In particular Article 13(1)(b) read in the light of recital 24 of Regulation No 1924/2006

[4] Article 13(3) of Regulation No 1924/2006.

[5] Recital 9 of Commission Regulation (EU) No 536/2013 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children’s development and health.