The Court of Justice of the European Union (CJEU) has delivered a significant judgment in Case C-386/23 (Novel Nutriology) on April 30, 2025, narrowing the conditions for health claims on botanical substances in food supplements. This ruling, stemming from a case involving a German company’s mood-enhancing supplements, states that such claims ‘cannot, at this stage, be used to promote food supplements‘ unless specifically authorized or falling under a narrow transitional regime (CJEU, 2025).
Far from a simple clarification, this decision further constrains an already problematic regulatory framework, demanding an urgent, comprehensive reform of the Nutrition and Health Claims Regulation (NHCR).
As this critical analysis will explore, the ruling appears to interpret conditions more narrowly than the more balanced approach established in the Court’s earlier Case C-363/19, where a broader acceptance of generally accepted scientific evidence for the transitional regime was recognized. This perpetuates a deep regulatory impasse that has drawn widespread criticism, stifling innovation within the €14.3 billion EU botanical supplements market and highlighting systemic failures mirrored in other sectors, such as probiotics. The full text examines this deadlock, contrasts it with more effective international models, and proposes practical paths forward.
Previous CJEU decision on botanical health claims
The Novel Nutriology case must be assessed in light of existing CJEU jurisprudence, most notably Case C-363/19 (Naturschutzbund Deutschland). That judgment articulated a more nuanced legal stance, with the Court holding that:
- ‘during the transition period, food business operators may, under their own responsibility, use claims relating to the effects of botanical substances on health, provided that those claims are accompanied by a reference to generally accepted scientific evidence and are not misleading‘.
The judgment marked an important clarification: the Court does not categorically reject claims based on traditional use, but requires that they be presented within the framework of scientific substantiation and consumer protection.
In doing so, it supports a more inclusive regulatory approach, recognising the different levels of scientific evidence (e.g. observational studies, rather than solely double-blind, placebo-controlled clinical trials on healthy individuals) and enduring value of botanicals in traditional phytotherapy (Leonti & Verpoorte, 2017; Santini et al., 2021).
The ‘transition’ period and its criticism
The ‘transition’ period for health claims on botanicals has extended far beyond reasonable timeframes, nearly two-decade (!), creating a regulatory limbo that the European Court of Auditors (ECA) specifically addressed in its 2024 report. The ECA criticized this situation as ‘an exceptional and unjustifiable delay in regulatory implementation’ that ‘undermines legal certainty in the single market’ (European Court of Auditors, 2024). This delay represents an administrative failure of extraordinary proportions, with far-reaching consequences for the entire European botanicals supply chain.
The contrast with traditional herbal medicinal products is particularly striking: under Directive 2004/24/EC, these benefit from a simplified registration process that recognises long-standing use as sufficient evidence of safety and efficacy. This results in an illogical situation where identical botanical substances are subject to vastly different regulatory burdens based solely on whether they are classified as food or medicine — without any justification for such disparity. The inconsistency between food and medicinal regulatory frameworks for botanicals in the EU has led to a market distorsion that harms both consumers and the supply-chain, while imposing high compliance costs ultimately borne by end users.
Member State approaches: the Italian example
In the continued absence of harmonised European Union guidance on health claims for botanical substances, Italy has proactively developed a national approach to safeguard consumer information and market stability. Spearheaded by the late Bruno Scarpa — a visionary figure at the Italian Ministry of Health and a close personal friend of the author — this national approach reflects not only his regulatory foresight but also a legacy of principled leadership that continues to influence the field of food and health policy.
Italy has formally recognised that ‘mandatory information concerning the physiological effects of botanical substances does not constitute health claims under EU Regulation 1924/2006‘ (Ministry of Health, Italy, 2023). This interpretation, in full compliance with the aforementioned regulation – which defines ‘claims’ as non-mandatory statements (Article 2.2.1):
- distinguishes between physiological effects supported by ‘generally accepted scientific evidence’, validated by the Ministry of Health and prescribed as mandatory, and voluntary ‘health claims’; and
- allows for the continued use of traditional knowledge, based on varying levels of scientific evidence, without misleading consumers or forcing operators to undertake unfeasible clinical trials in the context of homeostasis.
The Italian model offers a pragmatic template for other Member States and EU institutions to consider, as it addresses regulatory uncertainty without compromising public health or internal market principles. It also underscores the need for a harmonised EU framework that can integrate traditional use with scientific validation in a legally coherent manner.
A practical path forward: the EHPM Proposal
The European Federation of Associations of Health Product Manufacturers (EHPM) has developed a balanced, logical approach to resolve the botanical health claims impasse. Their proposal recognizes the unique characteristics of botanical substances and recommends a tiered, proportionate assessment system. According to their position paper (EHPM, 2021), the framework would establish three distinct categories:
- traditional use claims;
- well-established use claims;
- scientifically substantiated claims.
This tiered evidence system ranges from well-documented traditional use — defined as at least 30 years of use, including 15 within the EU — to more rigorous scientific research, each with appropriately qualified language. The proposal’s strength lies in its clear parallels with the successful Traditional Herbal Medicinal Products framework and its alignment with international models, such as those implemented in Japan, Canada and USA (see following paragraphs).
By valuing traditional knowledge while requiring proportionate validation, the EHPM proposal offers a practical solution to the current regulatory deadlock. Most importantly, it would provide European consumers with reliable botanical information while giving the industry a coherent and stable regulatory framework.
Alternative regulatory models: Japan’s FOSHU and Canada’s Natural Health Products Framework
Japan’s Food for Specified Health Uses (FOSHU) system, established in 1991, represents one of the most refined regulatory frameworks for functional foods globally. Under this system, foods and supplements making health claims undergo a proportionate evaluation process that considers both scientific evidence and traditional usage patterns. The system creates tiered evidential requirements, where substances with established historical use require less extensive clinical testing than novel ingredients. This approach has been credited with both protecting consumers and fostering innovation in Japan’s functional food sector.
Similarly, Canada’s Natural Health Products Regulations provide a distinct regulatory category for botanicals and other natural health products, with requirements that are ‘proportionate to the nature of the products and their historical use patterns‘ (Canadian Natural Health Products Directorate, 2022). This framework acknowledges traditional use evidence as a legitimate factor in the assessment process while maintaining appropriate safety standards. The Canadian framework successfully balances consumer protection with the recognition that botanical products have unique characteristics that distinguish them from both conventional foods and pharmaceutical products.
The U.S. approach: structure/function claims
The United States implements a pragmatic regulatory framework for botanicals through its structure/function claims system. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994:
- botanical supplements can make statements describing how ingredients affect the normal structure or function of the human body (the so called ‘functional claims‘ that were also defined within the first draft on European Commission proposal for the Nutrition and Health Claims Regulation) without requiring FDA pre-approval;
- these claims must be truthful and not misleading, and must carry a prominent disclaimer: ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease‘.
This balanced approach enables manufacturers to communicate substantive information about botanical effects while maintaining a clear distinction between supplements and pharmaceuticals.
Manufacturers must notify the FDA within 30 days of marketing products with structure/function claims and must maintain evidence substantiating such claims. This system acknowledges botanical traditions while providing consumer protection through transparent labeling, empowering consumers to make informed choices based on clearly qualified information about potential benefits.
The probiotics sector: regulatory paralysis preventing health innovation
The probiotic sector represents another striking example of the European Commission’s failure, having even banned the term ‘probiotic’ despite differing positions among some Member States and the stakes. Despite overwhelming scientific evidence supporting their beneficial effects on microbiome balance and digestive health, probiotics remain in a state of regulatory purgatory under the Nutrition and Health Claims Regulation (EC) No 1924/06. While the gut microbiome revolution has transformed our understanding of human health — linking microbial communities to everything from digestive disorders to mental health conditions — European consumers remain deliberately uninformed about even basic probiotic functions. This creates a Kafkaesque scenario in which consumers can purchase products containing specific bacterial strains but cannot be informed about their distinctive functions. The current framework imposes an unattainable evidential burden on probiotic manufacturers, requiring clinical trials designed for pharmaceuticals, with the further and extraordinary burden of performing them on healthy individuals.
This disproportionate approach is particularly troubling given that other major markets worldwide — including Japan, Canada, and the United States — have implemented balanced regulatory frameworks that acknowledge probiotics’ unique characteristics. The Commission’s continued inaction represents not just regulatory paralysis but a deliberate obstruction of public health information, forcing European citizens to seek guidance from unregulated online sources rather than receiving scientifically sound information on product labels. With the global probiotics market projected to reach €83 billion by 2027 (International Probiotics Association, 2023), the EU’s regulatory intransigence significantly disadvantages European manufacturers while denying citizens access to innovations that could substantially benefit public health. The Commission’s approach appears driven more by bureaucratic inertia than scientific rationale, creating a profound disservice to both European industry and citizens that demands immediate reform through a more proportionate, tiered approach to health claims assessment.
The economic cost of regulatory uncertainty
The EU botanical sector represents a significant economic force worth approximately €14.3 billion annually (European Botanical Forum, 2024), employing over 115,000 people directly and supporting an additional 450,000 jobs in related industries. According to recent market analyses, the European botanical supplements market has been growing at a compound annual growth rate of 7.2%, but this lags significantly behind global growth rates of 9.8% (Euromonitor International, 2024). This growth differential represents a lost opportunity cost estimated at €2.8 billion per year for the European economy.
The regulatory uncertainty surrounding health claims has been particularly damaging to small and medium-sized enterprises (SMEs), which constitute 78% of the botanical supplements sector in Europe. A 2024 industry survey found that 63% of SMEs in this space have postponed innovation initiatives specifically due to the unclear regulatory environment, while 41% reported diverting investments to non-EU markets where regulatory frameworks are more predictable (European Federation of Food Supplements Manufacturers, 2024).
Furthermore, the botanical sector’s significance extends beyond direct economic impacts through its support of sustainable agricultural practices and biodiversity conservation. Over 72% of botanical raw materials used in European supplements are sourced from specialized cultivations that maintain traditional farming practices and preserve plant genetic diversity (European Botanical Foundation, 2023). The regulatory limbo threatens these sustainable supply chains and the rural communities that depend on them.
Conclusions: a flawed approach requiring urgent reform
The latest CJEU judgment in Novel Nutriology underscores how the European approach toward botanical ingredients in food supplements remains fundamentally problematic. The EU regulatory framework fails to serve either industry or consumers effectively, creating a lose-lose situation that satisfies neither safety objectives nor information needs.
The contradiction becomes particularly acute when considering that many botanical substances have centuries of documented safe use and functionality in European traditions. As Santini et al. (2021) argue, ‘The current regulatory paradigm imposes pharmaceutical standards on products with fundamentally different characteristics and historical contexts, creating an inappropriate and ultimately counterproductive regulatory burden‘.
The Commission’s protracted delay in resolving this issue suggests a structural flaw in the regulatory approach. Requiring pharmaceutical-grade clinical evidence for substances with extensive historical use represents a fundamental category error in regulation. A comprehensive reform is urgently needed — one that establishes proportionate evidential requirements that acknowledge the unique position of botanical ingredients in European cultural and wellness traditions while ensuring basic safety standards.
The Japanese FOSHU model, the Canadian Natural Health Products and the US structure/function claims framework offer robust templates for such reform, demonstrating that consumer protection and information provision can be balanced effectively through more nuanced and contextually sensitive regulatory frameworks. Until such reform materialises, European citizens will remain caught in an information gap about products that have long been integral to regional wellness traditions, while the botanical supply chain — from heritage farmers to the supplement industry — suffers disproportionate and unjust disruption under a cloud of regulatory uncertainty that stifles both innovation and sustainable growth.
The Novel Nutriology ruling serves as a critical reminder that the time for half-measures and continued delay has passed. The European Commission must now demonstrate leadership by implementing a comprehensive reform of the Nutrition and Health Claims Regulation that delivers both consumer protection and a proportionate regulatory framework for the botanicals sector.
Dario Dongo
References
- Canadian Natural Health Products Directorate. (2022). Natural Health Products Regulations (SOR/2003-196). Government of Canada. https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/
- European Botanical Forum. (2024). Economic Impact Assessment of the EU Botanical Supplements Sector. Brussels: EBF Publications.
- European Botanical Foundation. (2023). Sustainability Report: Botanical Supply Chains in Europe. Amsterdam: EBF.
- European Court of Justice. (2020, September 10). Judgment of the Court (Second Chamber) of 10 September 2020, Case C-363/19, Konsumentombudsmannen v. Mezina AB. https://tinyurl.com/bddyjf2t
- Court of Justice of the European Union. (2025, April 30). Judgment of the Court (Fifth Chamber) in Case C‑386/23: Novel Nutriology GmbH v Verband Sozialer Wettbewerb eV. ECLI:EU:C:2025:304. https://curia.europa.eu/juris/document/document.jsf?docid=298696&doclang=EN
- European Court of Auditors. (2024). Special report on food information to consumers in the EU: Ensuring clear labelling and reliable claims (Special Report 2024/05). Luxembourg: Publications Office of the European Union. https://tinyurl.com/ykt2c3s5
- European Federation of Associations of Health Product Manufacturers. (2021). Botanical health claims on foods and food supplements in the EU: EHPM proposal. https://tinyurl.com/35whbhmb
- European Federation of Food Supplements Manufacturers. (2024). Industry Survey: Regulatory Impact on Innovation and Investment. Brussels: EFFSM.
Euromonitor International. (2024). Global Botanical Supplements Market Analysis 2019-2024. London: Euromonitor. - Hasler, C. M. (2008). Health claims in the United States: An aid to the public or a source of confusion? The Journal of Nutrition, 138(6), 1216S-1220S. https://doi.org/10.1093/jn/138.6.1216S
- Heinrich, M., Appendino, G., Efferth, T., Fürst, R., Izzo, A. A., Kayser, O., Pezzuto, J. M., & Viljoen, A. (2020). Best practice in research – Overcoming common challenges in phytopharmacological research. Journal of Ethnopharmacology, 246, 112230. https://doi.org/10.1016/j.jep.2019.112230
- Leonti, M., & Verpoorte, R. (2017). Traditional Mediterranean and European herbal medicines. Journal of Ethnopharmacology, 199, 161-167. https://doi.org/10.1016/j.jep.2017.01.052
- Ministry of Health, Italy. (2023). Guidelines on physiological effects of plant substances in food supplements (Circular No. 4234-P). Department of Food Safety, Nutrition, and Public Veterinary Health. https://www.salute.gov.it/imgs/C_17_pagineAree_1268_listaFile_itemName_2_file.pdf
- 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. Latest consolidated version 13/12/2014: https://tinyurl.com/36jkhfyf
- Santini, A., Cammarata, S. M., Capone, G., Ianaro, A., Tenore, G. C., Pani, L., & Novellino, E. (2018). Nutraceuticals: Opening the debate for a regulatory framework. British Journal of Clinical Pharmacology, 84(4), 659-672. https://doi.org/10.1111/bcp.13496
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
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