On 30 April 2025, the Court of Justice of the European Union (CJEU) issued a judgment in case C-386/23 (Novel Nutriology), ruling that the advertising, as well as the presentation and labeling of food products using health claims related to certain plant-based or herbal substances (botanical substances), is prohibited.
The CJEU emphasized clear boundaries regarding when health claims may be used and when they may not. Therefore, it is prohibited to use claims that have not been approved by the European Commission and included in the list of authorized health claims, or that are not covered by the transitional regime.
The question referred by the Federal Court of Justice in Germany is of key importance for the application of all pending health claims — that is, those not included in the EU lists of authorized claims and for which the Commission has not yet made a decision regarding their inclusion in the list of approved health claims.
The CJEU clearly ruled that:
“Article 10(1) and (3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, as amended by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008,”
must be interpreted as meaning that:
stands in the way of allowing, within the framework of commercial advertising of a food supplement containing “botanical substances” within the meaning of Commission Regulation (EU) No 432/2012 of 16 May 2012 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 — until the European Commission completes its assessment of health claims relating to botanical substances for the purpose of including them in the lists of authorized health claims referred to in Articles 13 and 14 of Regulation No 1924/2006, as amended — the use of specific health claims relating to such substances that describe or refer to psychological or behavioural functions, or the inclusion of references to general, non-specific benefits that such a substance provides for overall health and health-related well-being, where such a reference is not accompanied by a specific health claim included in the aforementioned lists, unless the use of such claims is permitted under the conditions laid down in Article 28(6) of that Regulation.
What was the background of the case?
On 26 June 2023, the Court of Justice of the European Union received a request (C-386/23) for a preliminary ruling (under Article 267 TFEU) concerning the interpretation of the rules on the use of health claims under Article 10(1) and (3) of Regulation 1924/2006. This request was submitted in the context of a dispute between Novel Nutriology GmbH and Verband Sozialer Wettbewerb eV regarding advertising conducted by Novel Nutriology to promote a food supplement using health claims related to the botanical substances it contains.
The allegations against the company concerned the cessation of advertising a product containing plant or herbal ingredients using claims that Verband Sozialer Wettbewerb e. V. considered to be unauthorized health claims — the so-called “botanical claims.” In this particular case, the focus was on “saffron extract” and “melon juice extract.” Novel Nutriology referred to data such as the following: the saffron extract Safr’Inside in Adapto-Genie was tested on 50 participants over a 30-day open-label study. At a daily dose of 30 mg of Safr’Inside, 77% of participants experienced improved emotional balance, felt more optimistic and happy after just two weeks of intake, and 66% also felt more relaxed and energetic. After 30 days, 11% of participants reported improved sleep quality. It was also stated that studies showed that after four weeks, melon juice extract combined with superoxide dismutase activity reduced feelings of stress and exhaustion. Furthermore, irritability and fatigue were reduced by 63%, leading to a significant improvement in quality of life.
The reference to such data was challenged by the German authority. As the proceedings progressed, a question was submitted to the CJEU, which read as follows:
“Can plant or herbal substances be advertised using health claims [Article 10(1) of Regulation (EC) No 1924/2006] or references to the general, non-specific benefits of a nutrient or food for overall good health and health-related well-being [Article 10(3) of Regulation (EC) No 1924/2006], if such claims have not been authorized under this Regulation and are not included in the lists of permitted claims provided for in Articles 13 and 14 of that Regulation (Article 10(1)), or if such references are not accompanied by a specific health claim included in the lists provided for in Articles 13 or 14 of that Regulation (Article 10(3)), for as long as the assessment by the European Food Safety Authority and the consideration by the Commission of the inclusion of the submitted claims relating to ‘botanical substances’ in the Union lists provided for in Articles 13 and 14 of Regulation (EC) No 1924/2006 have not been completed?”
The essence of the question was whether plant or herbal substances can be used in connection with health claims or references to general, non-specific benefits that a nutrient or food provides for overall good health and health-related well-being, if such claims have not been authorized and are not included in the list of permitted claims, or if such references are not accompanied by a specific health claim included in the list — for as long as the assessment by the European Food Safety Authority and the review by the Commission regarding the inclusion of the submitted claims related to “botanical substances” in those lists has not been completed.
The question therefore concerned the legality of:
- Health claims that have not yet been evaluated;
- Non-specific health claims, if they are not accompanied by specific, authorized health claims;
- The use of health claims depending on the timing of the application for their authorization.
What exactly did the CJEU rule?
Translation:
The Court emphasized that until the Commission completes its assessment of the so-called “on-hold” or “pending” statements, they cannot be used in advertising and marketing communications—except in cases covered by the transitional system (which did not apply in this particular case).
The Court based its decision on the fact that an increasing number of food products are being labeled and advertised using nutritional and health claims. To ensure a high level of consumer protection and to help them make informed choices, products placed on the market must be safe and properly labeled.
Thus, the CJEU emphasized that the fundamental prohibitions and requirements apply not only to advertising but are also necessary for labeling and presentation. This is related to Article 10(3) of Regulation 1924/2006.
According to the CJEU, the assessment in cooperation with the European Food Safety Authority (EFSA) and the requirement for authorization by the Commission are intended to ensure that a health claim is scientifically substantiated. Therefore, health claims concerning botanical substances cannot, at this stage, be used for the purpose of promoting, for example, dietary supplements.
What does this mean for entrepreneurs?
First of all, I want to clearly emphasize that the content of this ruling is not only relevant to dietary supplements. It applies to all beverages and products that refer to health claims from the pending list, i.e., dietary supplements, functional products, and products and beverages containing plant-based or herbal ingredients.
Firstly, there is a general ban on the use of health claims, except for those included in the lists of permitted claims referred to in Article 13 or Article 14 of Regulation No. 1924/2006.
Secondly, any references to general, non-specific benefits that a given nutrient or food provides for health must be accompanied by a specific health claim included in the authorized lists. This is because there is a distinction between two categories of health claims: on the one hand, specific health claims, and on the other, “general” health claims, which refer to overall, non-specific benefits for general health. This distinction must be taken into account when creating marketing communications.
Thirdly, the above-mentioned claims are based on generally accepted scientific evidence and must also be understandable to the average consumer.
Fourthly, attention must be paid to the different types of claims indicated in points (a), (b), or (c) of Article 13(1) of Regulation 1924/2006, as this is significant.
Fourthly, it is possible to use some of the pending claims, but under very specific conditions, i.e., health claims referred to in particular in Article 13(1)(b) of Regulation No. 1924/2006, which have not been evaluated and authorized in a Member State, may continue to be used provided that an application was submitted in accordance with this Regulation before 19 January 2008. Failure to submit such an application, or submission after that date, excludes their use. According to the CJEU, such claims cannot be permitted for use until the Commission completes its assessment.
What is important—and leaves some room for entrepreneurs—is that the situation may be different in the case of claims that fall under the transitional system provided for in the regulation. Although this case concerned health claims related to psychological functions, which, prior to the regulation’s entry into force, had not been evaluated and authorized in Germany. For such claims, an application for authorization should have been submitted to the competent national authority before 19 January 2008, which, as stated in the judgment’s reasoning, Novel Nutriology failed to do. For this reason, the use of these claims is prohibited, in the CJEU’s assessment.
The CJEU also emphasized that these requirements are not contrary to the freedoms of conducting business activity, and the obligation “to obtain prior authorization for the use of specific health claims and to include them in the lists referred to in Articles 13 and 14 of Regulation No. 1924/2006 does not deprive food market operators placing food containing botanical substances on the market of all possibility of marketing such food, but merely results in a prohibition on promoting it using health claims that have not been previously evaluated and authorized in accordance with that regulation.”
Is this the end of the doubts?
However, we know that despite the CJEU’s clear answers, in practice this ruling will raise many questions.
If you have any doubts:
- Does the ruling apply to your product, communication, or advertising?
- From when must the content of the ruling be followed?
- What if my product contains botanical ingredients—can I label and communicate them, and if so, how?
- How should general (non-specific) claims be used?
- What does “communication understandable to the average consumer” mean?
- Should you make any changes to your communication, labeling, or advertising—and if so, what kind?
- How should online and offline communication be conducted properly?
- What about communication related to scientific research or other functional products such as food for special medical purposes?
Or if you have other questions regarding labeling, marking, communication, advertising, and promotion of your products, feel free to contact us at: office@ajlaw.pl and juchanska@ajlaw.pl.