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Botanical substances and health claims: an awaited judgment

‍Valeria Paganizza

Many were waiting for it: operators, scholars, and enthusiasts in the field. It is the Judgment of the Court, Fifth Chamber, of April 30, 2025, in case C-386/23, Novel Nutriology GmbH v. Verband Sozialer Wettbewerb eV.

The Court of Justice of the European Union was called upon to interpret Article 10, paragraphs 1 and 3, and Article 28, paragraphs 5 and 6, of Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods, as amended by Regulation (EC) No. 109/2008.

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The framework of food information to consumers

Before delving into the heart of the controversy, it might be useful to briefly outline the regulatory framework in which the matter unfolds.

We know how each operator tries to promote their product in the best possible way, in an attempt to attract consumers’ attention and induce them to make a purchase. Regardless of the nature of the goods, it will be essential to observe the regulations of the market in which they will be sold and to verify which requirements are mandatorily provided, also based on the specific type of product, and which regulations are instead aimed at governing information that the operator intends to transmit voluntarily.

To address the case at issue, we will limit our considerations to the European Union market and the food sector. Information on food intended for consumers is regulated by Regulation (EU) No. 1169/2011, which identifies, in a horizontal manner (but with some exceptions), information that must necessarily accompany food, regardless of its nature (name, list of ingredients, substances that cause allergies or intolerances when used as ingredients, etc.). In other EU acts, there are also vertical provisions specific to certain categories of food that complement the horizontal law: consider olive oil, chocolate, fruit juices, or, as in the case of interest, food supplements. As for voluntary information, Regulation (EU) No. 1169/2011 merely stipulates, in Article 36, that such information must not mislead the consumer, as described in Article 7 of the same Regulation, which means that the message must not be ambiguous or confusing for the consumer, and, if applicable, that it must be based on relevant scientific data.

Health claims

Among the voluntary information characterised by a particular persuasive capacity (and for which, therefore, the vigilance against possible deception becomes more pronounced), we could count the so-called health claims. If, on the one hand, pursuant to Article 7 of Regulation (EU) No. 1169/2011, there is a prohibition on marketing a food claiming curative properties, on the other hand, Regulation (EC) No. 1924/2006 allows, under well-defined conditions, the use, on food, of nutrition or health claims. The expression «nutrition claims» identifies indications that assert, suggest, or imply that a food has particular beneficial nutritional properties, due to the energy value or the nutrients or other substances provided, not provided, or provided at a reduced or increased rate. The expression «health claim» instead identifies any information «that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health». Permitted nutrition claims are included in the list of the annex to Regulation (EU) No. 1924/2006, while health claims have a more complex procedure for authorisation, depending on the message they convey and their use prior to the dates specified by Regulation (EC) No. 1924/2006 for certain requirements. Trying to simplify, we could classify health claims as follows:

First group:

  • Claims referring to the role of a nutrient or other substances in growth, development and the functions of the body (Article 13, par. 1, lett. a) of Regulation (EC) No. 1924/2006);
  • Claims on psychological and behavioural functions (Article 13, par. 1, lett. b) of Regulation (EC) No. 1924/2006);
  • Claims on slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet (Article 13, par. 1, lett. c) of Regulation (EC) No. 1924/2006).

For these claims, subject to the Authority’s opinion, the Commission had to draw up a list based on the indications received from the Member States by January 31, 2008, provided that the claims were based on generally accepted scientific evidence and were easily understandable to the average consumer. The list is now contained in the Annex to Regulation (EU) No. 432/2012.

If operators want to use a claim not included in the aforementioned list of the Commission, they should submit an application to the competent national authority, which will forward it to the Commission, the other Member States, and the European Food Safety Authority. Based on EFSA’s opinion, the Commission will authorise the health claim or reject the application.

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Second group:

-Claims on reduction of disease risk claims (Article 14, par. 1, (a) of Regulation (EC) No. 1924/2006).

- Claims referring to children’s development and health (Article 14, par. 1, (b) of Regulation (EC) No. 1924/2006).

Each of these claims can only be used with prior authorisation from the Commission (Article 17 of Regulation (EC) No. 1924/2006), based on an opinion from the European Food Safety Authority (Article 16 of Regulation (EC) No. 1924/2006), upon request from the interested party, sent to the competent national authority and forwarded by it to the Commission (Article 15 of Regulation (EC) No. 1924/2006).

Moreover, according to Article 10, par. 3 of Regulation (EC) No. 1924/2006 «Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim» that was authorised and thus included in the lists provided for in Article 13 or 14.

Regulation (EC) No. 1924/2006 also provided for a transitional regime (Article 28). As far as the present matter is concerned, in particular, health claims regarding the role of nutrients or other substances for growth, development, and functions of the body (Article 13, paragraph 1, letter a)) could have been provided even after the entry into force of Regulation (EC) No. 1924/2006, until the adoption of the European Union list, without prejudice to the responsibility of the operator who decided to use them (Article 28, par. 5).

Health claims other than those just mentioned and those related to the reduction of disease risk (Article 14, paragraph 1, letter a) of Regulation (EC) No. 1924/2006) used before the entry into force of Regulation (EC) No. 1924/2006, already evaluated and authorised in a Member State, would have been communicated to the Commission by January 31, 2008, along with the scientific data supporting them and authorised or rejected by it, following the opinion of the European Food Safety Authority (Article 28, par. 6).

Health claims, food supplements and botanicals

Health claims are often used on food supplements, which are «foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities».

Up to this point, everything is clear... or at least it seems so. Among the ingredients of supplements that find specific regulation in the aforementioned Directive, however, we only have vitamins and minerals, while provisions on other ingredients with physiological effects are left to the Member States. And it is at this point that the issue of so-called botanicals emerges, that is, plant substances and preparations intended to be used in dietary supplements. As we mentioned in a previous article, there is no harmonised list (which means applicable in all member countries) in the European Union, of substances and plant preparations to be used in supplements, with the consequence that each State is allowed to adopt its own national provisions. If the regulatory framework on botanicals is thus fragmented, the issue of using health claims on food supplements containing them appears to be much more delicate.

On the one hand, as confirmed by recital 10 of Regulation (EU) No. 432/2012, there are a number of claims regarding the effects of substances derived from plants or herbs (botanicals, indeed) that had been submitted for evaluation and were awaiting the scientific opinion of the European Food Safety Authority. On the other hand, as previously mentioned, Article 28 of Regulation (EC) No. 1924/2006 authorised the transitional use of claims whose evaluation by the Authority or examination by the Commission had not yet been completed, under certain conditions. Health claims for which transitional use had been permitted would have been published on the Commission’s website. Despite thirteen years having passed since Regulation (EU) No. 432/2012, the situation remains unchanged: the evaluation of health claims for botanicals is still pending. In the meantime, some countries (including Italy) have adopted national provisions that identify certain substances and plant preparations that can be used in supplements, indicating possible health benefits. The responsibility remains with the operator to demonstrate that the food placed on the market is indeed suitable, in the suggested quantities for use, to perform the declared functions.

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C-386/23: main proceedings

We therefore have the essential elements to understand what happened in the case at issue. A food business operator had put on the market a dietary supplement based on saffron extract and melon juice extract, accompanying it with health claims related to mood improvement, for the first ingredient, and the reduction of stress and fatigue, for the second. A professional association aimed at protecting the interests of its members, considering the health claims used by the operator to be prohibited as they were not authorised, and the extrajudicial attempts to inhibit their use being in vain, sued the operator, with granting of the application both in the first instance and on appeal. In the subsequent trial, the Federal Court of Justice suspending the main proceedings, referred a preliminary question to the Court of Justice of the European Union as follows: «May plant or herbal substances (“[botanical substances]”) be advertised with health claims (Article 10(1) of Regulation No 1924/2006) or with references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being (Article 10(3) of Regulation No 1924/2006) without those claims being authorised under that regulation and included in the list of authorised claims pursuant to Articles 13 and 14 of [that regulation] (Article 10(1) of [Regulation No 1924/2006]) or without those references being accompanied by a specific health claim contained in one of the lists referred to in Articles 13 or 14 of [that regulation] (Article 10(3) of [Regulation No 1924/2006]), pending completion of the evaluation by [EFSA] and the examination by the Commission of the inclusion of the claims notified in respect of “[botanical substances]” in the Community lists referred to in Articles 13 and 14 of Regulation No 1924/2006?» (point 42 of the Court’s Judgement).

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C-386/23: the Court’s Judgment

The solution reached by the Court is not surprising, being the natural consequence of a linear reasoning that starts, first and foremost, from the distinction between two types of health claims. On the one hand, the Court considers specific health claims, pursuant to Article 10 par. 1 of Regulation (EC) No. 1924/2006, claims whose use is subject to prior authorisation by the Commission. On the other hand, the EU Judge “places” “general” health claims, which are only permitted if accompanied by a specific claim. The Court highlights, at this point, that, as confirmed by the Commission, the evaluation of health claims concerning botanicals has been suspended and the list has therefore not been approved (point 55 of the judgement).

The claims at issue in the main proceedings are not only not authorised under Article 10 of Regulation (EC) No. 1924/2006, but they are also not included among the claims whose use is permitted on a transitional basis: for one, a late application was submitted, and for the other, no procedure had been initiated (point 60 of the judgement). The Court thus recognises that health claims such as those in the main proceedings cannot be used because they are not included in the transitional regime; it further confirms the possibility of applying health claims already used before Regulation (EC) No. 1924/2006, in accordance with the legislation of the Member States, provided they are included among those communicated, pursuant to Article 28, paragraph 6, letter a) of the aforementioned Regulation, by the Member States to the Commission by January 31, 2008, and subsequently authorised by the Institution (point 59 of the judgement), without prejudice to the responsibility of operators for their own choices.

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