No health claims for botanicals, unless… – implications for the Dutch market
Posted: May 19, 2025 Filed under: Advertising, Food Supplements, Health claims Comments Off on No health claims for botanicals, unless… – implications for the Dutch market
Last April 30th, the European Court of Justice (ECJ) answered the question whether so-called ‘on-hold’ health claims related to botanical substances are permitted (case C-386/23). As covered in an earlier blogpost, this question was submitted to the ECJ by the German Bundesgerichtshof in the summer of 2023. In this blogpost, we discuss the outcome of the case, the transitional regimes of article 28(5) and (6) Claims Regulation, and the implications of the case for the Netherlands.
The case
The question at hand came up during national German court proceedings concerning a food supplement of the company Novel Nutriology, which was advertised as mood enhancing and reducing feelings of stress and fatigue thanks to its extracts of saffron and melon juice. Health claims for botanical substances like the above are currently on-hold, since the European Commission has not yet completed its examination of such claims for the purposes of their inclusion in the positive lists of authorized health claims. Due to the absence of botanical-related claims on these lists, such claims can therefore not be used based on article 10(1) and (3) Claims Regulation. It namely follows from this article that the use of a specific health claim is only permitted if it is included on one of the positive lists, and any generic health claim must be accompanied by such a specific claim. The referring court therefore wanted to know whether it is indeed prohibited to promote botanicals with health claims as long as such claims are not included on the positive lists.
Prohibited, unless….
The ECJ confirmed that until inclusion of the so-called on-hold claims on the positive lists, it is prohibited to promote botanicals using health claims. This is however different if the use of such claims is permitted under the transitional measures provided for in article 28(6) Claims Regulation. Unlike earlier speculations, this applies not only to specific (art. 10(1)) claims but also to generic (art. 10(3)) claims. In other words: generic health claims for botanicals are prohibited, unless they are accompanied with a specific claim that meets the requirements of the transitional regime. Since the referring court starts from the premise that the health claims at issue are psychological claims, we note that the ECJ only covers such claims and no physiological function claims in its ruling, on which more later.
Transitional measures deepened
Article 28 of the Claims Regulation includes transitional measures that were intended to enable food businesses to adapt to the requirements of the regulation when it became applicable back in 2007. The transitional measures in art. 28(5) and (6) Claims Regulation however also apply to the botanical-related health claims that are currently still on-hold. This is made explicit in recitals 10 and 11 of Regulation 432/2012, which establishes a list of authorized function health claims (also known as Article 13 claims). As referred to by the ECJ in its ruling, the foregoing also follows from recital 9 of Regulation 536/2013, which amends Regulation 432/2012.
Article 28(5) and (6) Claims Regulation set forth different transitional regimes for respectively physiological function claims and other health claims. As relevant for the type of health claims made by Novel Nutriology, the ECJ applies the test set forth in article 28(6). The first question to be answered is whether the health claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. Based on the input of the referring court, the ECJ relies here on the premise that this is the case. The claim can therefore continue to be used, provided that it either has been subject to evaluation and authorization in a Member State, or has been submitted for EU authorization prior to 19 January 2008.
Although not specified by the ECJ, it does not seem a requirement that the food business at stake has been using the claim before the data of application of the Claims Regulation itself and has, where relevant, made itself an application for authorization. The literal text of article 28(6) Claims Regulation does also not require this as it doesn’t specify the required user or applicant. A food business that wishes to use an on-hold claim does therefore not need to be the original user and applicant of the claim.
Novel Nutriology nevertheless fails to comply with the requirements of article 28(6). As was noted by the referring court, the health claim related to the saffron extract was the subject of a late application past the deadline set in the transitional measures. For the melon extract claim, no application has been submitted at all. Novel Nutriology can therefore not make the health claims at stake.
What about physiological function claims?
While the ECJ did not see reason to elaborate on the transitional measures for physiological function claims as dealt with in article 28(5) Claims Regulation, the Advocate-General does indicate in his Opinion what if the respective health claims were to be considered as such. These claims may than continue to be used under the conditions set forth in that article so long as the positive list of health claims has not been adopted in respect of botanical substances.
The question however remains whether generic claims accompanied with physiological function claims can be made under the applicable transitional measures to promote botanicals. An analogical application of the ECJ’s ruling to the transitional measures of article 28(5) Claims Regulation suggests that this should be possible, which is also the conclusion of the Advocate-General in his Opinion. A difference between article 28(5) and 28(6) Claims Regulation is however that the former explicitly refers to physiological function claims as meant in article 13(1)(a) Claims Regulation, whereas the latter covers “health claims other than those referred to in Article 13(1)(a) and in Article 14(1)(a)”. In accordance with this European implementation assessment, it may therefore as well be concluded that generic claims are not dealt with under the transitional measures of article 28(5). Whether such a strict (literal) interpretation should indeed be applied, remains unanswered.
Implications for the Netherlands
As explained in our earlier blogpost on this topic, health claims for botanicals are accepted in the Netherlands if the roadmap of the Dutch agency regulating health products (the Keuringsraad) in cooperation with the Dutch food safety authority (NVWA), is met. Also the NVWA Handbook on Nutrition and Health Claims provides a detailed guidance on the use of on-hold claims for botanical substances.
While the roadmap and NVWA handbook only accept on-hold claims with an ID number that is present on the so-called ‘on-hold’ list, we notice that in practice little attention is paid to the exact requirements of the transitional measures under the Claims Regulation. The ruling at stake may therefore be seen as a wake-up call for compliance. We recognize at the same time that it may not always be easy to prove e.g. that an on-hold claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. So far we have not seen enforcement on this point, so future will have to tell whether this may change.
We further notice that the topic of generic claims that are substantiated with on-hold claims is not covered in the Dutch guidance materials. The case at stake however taught us that this also falls under the transitional regime of article 28(6) Claims Regulation. Since it remains unclear how this plays out under the transitional regime of article 28(5), it would be helpful for businesses if the Dutch enforcement body can share its take on this in its Handbook.
Conclusion
When it comes to psychological and behavioral function claims, the case at stake clarifies that the transitional measures of the Claims Regulation apply both to specific and generic claims. How this plays out for physiological function claims has not been covered by the ECJ, and could be argued different ways. It would be helpful if this question could therefore be answered in national guidance materials, and until that time we recommend that food businesses have a robust legal justification for their interpretation of the transitional measures, if these are what they rely on for their use.
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