I. Facts

Novel Nutriology is a German company that marketed a food supplement containing saffron extract and melon juice extract.Footnote ¹ The company advertised this product on its website using specific health-related claims about these botanical substances. The disputed claims included “mood-enhancing saffron extract,” detailed assertions about a study showing that 77 per cent of subjects experienced improved emotional balance and felt more optimistic after two weeks of using 30 mg of Safr’Inside daily, and claims that melon juice extract with superoxide dismutase activity reduced stress and fatigue by 63 per cent after four weeks.Footnote ²

Verband Sozialer Wettbewerb eV (VSW), a German trade association with the statutory task of defending its members’ commercial interests, challenged these marketing practices. On 23 October 2019, VSW gave Novel Nutriology formal notice to cease using these claims, arguing that they violated Article 10 of the Regulation (EC) No 1924/2006 (Nutrition and Health Claims Regulation, NHCR).Footnote ³ VSW contended that Article 10 prohibits health claims unless they are included in the lists of authorised claims established under Articles 13 and 14 of the NHCR.

Importantly, the evaluation process for botanical substance health claims has been suspended by the European Commission for several years. Although Article 13(3) of the NHCR required the Commission to consult the European Food Safety Authority (EFSA) and adopt lists of authorised health claims by 31 January 2010, the Commission acknowledged that “the evaluation of health claims relating to botanical substances has been suspended and the list of such claims has not yet been drawn up.”Footnote ⁴

When Novel Nutriology failed to comply with the formal notice, VSW brought proceedings before the Landgericht Hamburg (Regional Court, Hamburg) seeking an injunction to prohibit the company from promoting its product using the contested claims.Footnote ⁵ The Regional Court upheld the action, and Novel Nutriology’s subsequent appeal to the Oberlandesgericht Hamburg (Higher Regional Court, Hamburg) was dismissed.Footnote ⁶

During the subsequent court proceedings, lower German courts ruled against Novel Nutriology declaring their health claims illegal.Footnote ⁷ The case then moved up to Germany’s highest court, which sought guidance from the Court of Justice of the European Union (CJEU, hereinafter also referred to as the Court). Essentially, the German court asked whether companies could use health claims for plant-based products without official approval while waiting for EFSA’s assessment and the European Commission’s review for inclusion on approved lists.Footnote ⁸

In his Opinion of 17 October 2024, Advocate General Rantos recommended the Court respond to this question in the negative, except where claims might qualify for temporary use under Article 28 of the NHCR.Footnote ⁹ Rantos reasoned that the NHCR establishes a complete framework requiring scientific validation and official approval before health claims can appear in marketing materials.

In particular, Rantos argued that the European Commission’s decision to pause reviewing botanical claims does not free companies from regulatory obligations.Footnote ¹⁰ While this regulatory standstill deserves criticism and could potentially lead to legal action against the Commission for inaction,Footnote ¹¹ the Advocate General pointed out that the NHCR contains interim measures permitting certain claims to remain in use during the evaluation period.Footnote ¹²

In this respect, Article 28(6) allows health claims beyond those describing “a nutrient’s or substance’s role in growth, development and bodily functions” (Article 13) to continue if they were previously approved by a Member State and, crucially, if applications were filed before 19 January 2008. Although the national court must ultimately decide if these conditions apply to this particular case, Rantos observed that one claim was filed too late (2009) and the other was never submitted, suggesting these interim provisions do not apply here.Footnote ¹³

II. Judgment

The CJEU delivered its judgment on 30 April 2025, ruling that health claims about botanical substances cannot be made without authorisation pending Commission evaluation, unless permitted under transitional provisions. The judgment opens by reconstructing the normative framework created by the NHCR. It confirms that Article 10(1) “lays down a prohibition in principle of health claims, with the exception of those included in the lists of authorised claims referred to in Article 13 or 14 of that regulation.”Footnote ¹⁴ Furthermore, Article 10(3) requires that “any reference to general, non-specific health benefits of a nutrient or food must be accompanied by a specific health claim included in the lists provided for in Article 13 or 14 of that regulation.”Footnote ¹⁵

The Court emphasised that this creates a binary system where “the use of a specific health claim is permitted only if it is included in one of the lists of authorised health claims provided for in Article 13(3) and Article 14(1) of that regulation, whereas any general health claim must be accompanied by such a specific claim.”Footnote ¹⁶

Addressing the central question, the Court acknowledged that the Commission had suspended the evaluation process. At the same time, it held that this did not exempt botanical substance claims from regulatory requirements. The Court noted that “health claims the consideration of which has not yet been completed will remain published on the website of Commission and may continue to be used in accordance with the transitional measures provided for in Article 28(5) and (6) of the NHCR.”Footnote ¹⁷

However, the Court held that Novel Nutriology cannot benefit from these transitional provisions. Under Article 28(6)(b), health claims describing psychological or behavioural functions “may continue to be used provided that an application was submitted in accordance with that regulation before 19 January 2008.”Footnote ¹⁸ Since Novel Nutriology had submitted one claim late and no application for the other, “the use of claims such as those at issue in the main proceedings cannot be permitted under the transitional regime provided for in Article 28(6).”Footnote ¹⁹

The Court grounded its interpretation in the NHCR’s objectives, stating that it “seeks to ensure the effective functioning of the internal market while providing a high level of consumer protection, in particular against misleading claims.”Footnote ²⁰ The Court emphasised that “the use of health claims should only be authorised in the European Union after a scientific assessment of the highest possible standard” conducted by EFSA.Footnote ²¹

Regarding potential interference with freedom to conduct business under Article 16 of the Charter, the Court acknowledged this concern yet holds that such freedom “is not absolute but must be viewed in relation to its social function.”Footnote ²² Crucially, the Court stated that “the objective of the protection of health takes precedence over economic considerations, the importance of that objective being such as to justify even substantial negative economic consequences.”Footnote ²³

The Court held that the prohibition achieves “a fair balance between the fundamental rights which must be reconciled, without disproportionately impairing the legitimate right of economic operators in the food sector to pursue their entrepreneurial activity.”Footnote ²⁴ The restriction is justified because it merely prohibited promotion through unauthorised health claims rather than preventing the marketing of botanical products entirely.Footnote ²⁵

III. Comment

Prior to this judgment, the Commission’s prolonged suspension of botanical substance evaluations had created a legal vacuum that different national courts were interpreting inconsistently. In the German legal system, in particular, two competing interpretations of the NHCR’s requirements had emerged. The first interpretation, adopted by some German courts, argued that Article 10(3) is not applicable in such circumstances. This is because the Commission and EFSA have indefinitely suspended the examination of health claims relating to botanical substances, making it impossible for food business operators (FBOs) to obtain decisions on specific health claims.Footnote ²⁶

Conversely, the second interpretation, predominant among German courts,Footnote ²⁷ maintained that Article 10(3) remains applicable to botanical substances. This view emphasises that completely exempting botanical substances from these restrictions would risk consumer confusion between food supplements and medicinal products, allowing the continued use of untested health claims.

This regulatory uncertainty created problematic consequences for consumer understanding. The scale of this problem becomes apparent when considering that Member States submitted approximately 44,000 health claim proposals by January 2008, which, after removing duplications, resulted in about 4,600 unique proposals requiring evaluation.Footnote ²⁸ The botanical claims constitute a significant portion of the unresolved cases from this massive submission.Footnote ²⁹

This regulatory uncertainty also risked distorting market competition. FBOs dealing with botanical substances faced an environment where compliance strategies could vary significantly between Member States, undermining the NHCR’s goal of creating a level playing field across the EU.

Against this backdrop, the judgment provides much-needed clarity. The judgment establishes that the NHCR’s prohibition on unauthorised health claims operates independently of the Commission’s administrative progress in completing evaluations. The Court’s overall reasoning is consistent with its previous case law in this area. The judgment echoes the rigorous approach taken in Case C-524/18, Dr. William Schwabe, where the Court strictly interpreted the requirements for linking generic and specific health claims.Footnote ³⁰ Similarly, the principle that public health considerations take precedence over economic interests reflects the Court’s position in cases such as C-452/20, Agenzia delle dogane e dei monopoli,Footnote ³¹ and C–151/17, Swedish Match.Footnote ³²

The Court’s commitment to consumer protection and the maintenance of high scientific standards for health claims is commendable. This strict interpretation reflects the core function of the NHCR, which was designed to eliminate the information asymmetry between producers and consumers. The NHCR establishes that all claims concerning nutritional or health benefits must be authorised before any use, with all unauthorised claims being prohibited regardless of available supporting literature. According to the Court, allowing unauthorised claims during administrative delays would undermine the entire regulatory framework and potentially expose consumers to misleading or unsubstantiated health claims.

The Court’s reasoning reflects the application of the precautionary principle, which allows regulatory authorities to take protective measures when scientific evidence is incomplete but potential risks to health exist.Footnote ³³ Under this principle, regulators may restrict activities even when scientific uncertainty persists, provided that the measures are proportionate to the potential risk and subject to review as new evidence emerges.Footnote ³⁴ In the context of botanical health claims, the precautionary principle supports maintaining the prohibition on unauthorised claims until proper scientific evaluation can be completed, protecting consumers from potentially misleading information.

However, the judgment highlights a regulatory problem that has persisted throughout the history of the NHCR. The prolonged failure of the Commission to finalise the evaluation of health claims on botanical substances arguably serves neither economic nor public health purposes optimally. The Regulatory Fitness and Performance Programme (REFIT) evaluation identified the botanical claims issue as one of the two main reasons why the NHCR currently fails to completely reach its objectives.Footnote ³⁵

This regulatory impasse stems from challenges in applying conventional evidence standards to botanical products. The scientific requirements established by EFSA demand that health claims be substantiated by the “highest scientific standard,” typically requiring “placebo-controlled randomised control trials.”Footnote ³⁶ Research shows that foods often work in subtle ways and affect multiple parts of the body at once.Footnote ³⁷ Current testing methods focus on one ingredient affecting one specific area, but food products may actually help the body in several different ways. Because these benefits are often mild, scientific studies might not detect them even though people notice positive effects when they eat these foods regularly.Footnote ³⁸

Additionally, current evidence requirements may create financial barriers for small and medium enterprises seeking authorisation for botanical health claims.Footnote ³⁹ This economic dimension may exclude smaller companies from the market for authorised health claims,Footnote ⁴⁰ contributing to market concentration that serves neither innovation nor consumer choice.

Furthermore, a regulatory anomaly exists where botanical substances may be evaluated under different evidential frameworks depending on their regulatory classification. Traditional herbal medicinal products under Directive 2001/83/EC may rely on traditional use evidence under certain circumstances,Footnote ⁴¹ while identical botanical substances in food products face stricter evidentiary requirements under the NHCR. This creates inconsistency in how traditional knowledge is valued across different regulatory domains.

These regulatory and economic considerations have prompted stakeholders to debate whether well-documented traditional knowledge should receive some recognition in the health claims authorisation process. The European Commission’s REFIT consultation process exposed significant divisions among stakeholders, with industry associations largely supporting traditional use evidence while consumer protection groups and pharmaceutical representatives opposing it.Footnote ⁴²

Stakeholders supporting traditional use evidence argue that withholding information about traditional benefits may not serve consumer interests, whereas opponents contend that claims not substantiated by controlled trials may mislead consumers.Footnote ⁴³ Consumer research indicates that the reality is more nuanced than either position suggests.Footnote ⁴⁴ Consumers demonstrate limited understanding of health claims generally,Footnote ⁴⁵ highlighting the need for clearer communication strategies regardless of the evidential basis for claims.

Based on these considerations, the analysis points towards developing more nuanced regulatory approaches. Examples of alternative frameworks can be found in several non-European legal systems. For instance, Japan’s Food for Specified Health Uses (FOSHU) system, established in 1991, evaluates foods and supplements making health claims through a process that considers both scientific evidence and traditional usage patterns,Footnote ⁴⁶ where substances with established historical use may require less extensive clinical testing than novel ingredients.Footnote ⁴⁷ Similarly, Canada’s Natural Health Products Regulations establish requirements for botanicals and other natural health products that are “proportionate to the nature of the products and their historical use patterns.”Footnote ⁴⁸ The United States allows qualified health claims based on credible scientific evidence that may include various forms of research, accompanied by disclaimers indicating the quality of supporting evidence.Footnote ⁴⁹ These diverse approaches suggest that addressing the regulatory impasse surrounding botanical health claims may require comprehensive reconsideration of how EU food law can accommodate different forms of evidence while maintaining consumer protection.