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The Fragmented Regulatory Puzzle of so-called Botanicals in the EU between Food and Medicine

Published online by Cambridge University Press:  05 February 2026

Archana Singh Open the ORCID record for Archana Singh [Opens in a new window]
Archana Singh*
Affiliation:
Department of Land, Environment, Agriculture and Forestry, Universita degli Studi di Padova, Italy
*
Email: archana.singh@unipd.it
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Abstract

Botanical supplements occupy a regulatory grey area between food and medicine within the European Union, a situation that has given rise to a series of interrelated challenges. This paper highlights regulatory dysfunctions across several dimensions: definitional voids in EU food law, unclear food–medicine classification boundaries, fragmented market access rules, and inadequate safety monitoring systems. These regulatory gaps impose costs on business operators, restrict consumer access, and result in uneven protection across Member States. The article also focuses on safety concerns, which are, however only one element of this broader puzzle. To address such systemic difficulties, the paper proposes the introduction of harmonised pre-market notification and post-market surveillance mechanisms, with a specific focus on botanical supplements. These measures could help reconcile market accessibility with stronger consumer protection while supporting innovation. Admittedly, they may not resolve all regulatory challenges, particularly the thousands of health claims that remain on hold. Nevertheless, they might offer a practical foundation for addressing long-term, often overlooked safety concerns related to botanicals. It remains to be seen whether they could also contribute to resolving the interconnected regulatory issues in this sector, potentially paving the way for broader reform.

Keywords

botanical supplementsEU food lawregulatory gapssafety monitoring

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Type
Articles
Information
European Journal of Risk Regulation , First View , pp. 1 - 13
Creative Commons
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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2026. Published by Cambridge University Press

I. Introduction

In the 1990s, a series of kidney failure cases in Belgium were traced to a slimming product that mistakenly contained Aristolochia fangchi, a plant known to produce nephrotoxic and carcinogenic compounds.Footnote 1 More than one hundred patients were affected, and many subsequently developed cancers. This incident brought renewed attention to a long-standing issue in European regulatory policy: the ambiguous legal status of botanical products, which continue to occupy an uncertain position between food and medicine.

In response to such crises and to broader concerns regarding consumer safety, the European Union (EU) introduced several measures intended to strengthen oversight. Nevertheless, these measures have not resolved deeper structural gaps. Botanical products, ranging from herbal infusions to tinctures and concentrated extracts, may be regulated either as medicinal products or as food supplements, depending on their formulation, marketing, and the Member State in which they are sold.

Because risk assessment and management remain inconsistent across the EU,Footnote 2 these products registered that are registered as medicines undergo EU-wide pre-market authorisation and post-market pharmacovigilance. In contrast, supplements often bypass centralised safety checks and systematic monitoring.Footnote 3

The long-held assumption that historical use guarantees safety has become increasingly uncertain. EFSA has noted that modern extraction techniques and concentrated formulations may deliver higher doses or altered compositions compared to traditional preparations.Footnote 4 Several botanical supplements have been associated with adverse health outcomes, including liver injury linked to concentrated green tea extractsFootnote 5 and neurological effects associated with valerian preparations.Footnote 6 Despite these risks, no EU-wide mechanism exists to systematically collect and assess adverse events. Although some Member States, such as France and Italy,Footnote 7 have established national nutrivigilance systems, most do not have comparable monitoring mechanisms.

Alongside these gaps in monitoring and safety oversight, the EU also struggles with another critical part of the regulatory puzzle: health claims for botanical supplements. Vitamins and minerals can rely on well-established benefits, but botanicals face much stricter approval standards. EFSA has repeatedly refused to accept claims based only on traditional use. This leaves products stuck between different national rules and increases fragmentation of the internal market. Consequently, thousands of botanical health claims have remained pending for more than a decade, contributing to divergent national practices and increasing market fragmentation within the internal market.Footnote 8

This paper examines these interconnected legal and practical gaps in the EU regulatory framework for botanical supplement products. Safety monitoring is one piece of the larger “regulatory puzzle.” The analysis identifies the core structural challenges, explains why they persist, and explores how existing legislation contributes to systemic shortcomings that affect both consumer protection and the functioning of the internal market.

II. Botanicals in the EU: rules, gaps and impact

This section explores the legal and regulatory grey zones surrounding botanicals used as food products in the EU, from missing definitions to cross-border inconsistencies that impact safety, market access and consumer protection.

1. When the law lacks a definition: the regulatory void in EU food law

Botanical products such as herbal infusions, ginseng preparations, or valerian extracts occupy an uncertain position within the EU regulatory framework.Footnote 9 The rules governing them remain incomplete and incoherent, largely because EU food law does not provide a harmonised definition of “botanical” or “botanical product.” Instead, these substances are generally grouped under the residual category of “other substances,” which sits outside the detailed lists and specific compositional standards established for vitamins and minerals.

While Italy (as well as EFSA) consistently uses the term “botanical,” other countries either define these substances differently or do not categorise them at all. Germany, for instance, regulates them under the broader category of “other substances,” whereas France and the Netherlands prefer terms like “plant substances” or “herbal preparations.”Footnote 10

The central framework of EU food law is Regulation (EC) No 178/2002,Footnote 11 which sets out general principles of food safety and establishes the precautionary principle.Footnote 12 Although this framework empowers regulators to act where safety concerns arise, the application of these principles to botanical products has been inconsistent across Member States, in part because of the complex and variable composition of plant materials.

Directive 2002/46/EC on food supplements further illustrates this asymmetry.Footnote 13 The Directive contains detailed provisions on permitted forms, purity criteria and specifications for vitamins and minerals. By contrast, botanical products are left within the residual category of “other substances,” without harmonised compositional requirements or EU-wide safety criteria. This structure reflects a legislative choice to postpone harmonisation of botanicals to future instruments, a process that remains incomplete more than two decades later. As a result, operators face divergent national requirements, and consumers encounter products subject to markedly different levels of oversight.

Regulation (EC) No 1924/2006 on nutrition and health claims adds another layer of complexity for botanical products.Footnote 14 Unlike vitamins and minerals, which benefit from harmonised and authorised health claims, botanical products remain without approved claims at EU level. Thousands of their claims have been placed in a pending category since 2010, resulting in divergent national practices. For example, certain Member States, such as Spain,Footnote 15 permit specific stress-related claims for Withania somnifera, whereas other Member States, including Denmark,Footnote 16 prohibit them or apply restrictive conditions. This divergence leads to uneven market access and creates a situation in which consumers encounter the same botanical product presented with different claims depending on the jurisdiction, making it difficult to distinguish between substantiated and unsubstantiated information.

The absence of a harmonised definition of botanical products in EU food law also means that these substances are frequently assessed through neighbouring regulatory instruments, rather than under a dedicated framework tailored to their characteristics. One of the most significant of these instruments is the Novel Food Regulation (EU) 2015/2283. Under this Regulation, a botanical preparation qualifies as a novel food where there is no evidence of significant consumption within the Union prior to 15 May 1997, or where a new production process is considered to alter its composition or structure in a manner relevant for safety assessment.Footnote 17 Traditional preparations with documented pre-1997 use, such as herbal infusions or dried plant parts, usually fall outside this regime. By contrast, concentrated extracts, isolated constituents, or technologically advanced formulations may require pre-market authorisation supported by a scientific evaluation.

This structure reflects the precautionary orientation of the Novel Food Regulation, which requires more rigorous scrutiny where historical use cannot be demonstrated. As Paganizza observes, reliance on factors such as consumption history and production methodology can lead to different regulatory outcomes for products derived from the same plant species.Footnote 18 This means that variations in regulatory treatment do not necessarily arise from intrinsic differences in the plant material itself, but rather from the need to resort to secondary criteria in the absence of a dedicated and harmonised definition for botanical products in EU food law.

2. When function dictates fate: where EU law blurs the line between nutrition and cure

Determining whether a botanical product falls within the food supplement framework or the medicinal product regime is a central regulatory question, as this classification governs the applicable safety requirements, labelling rules and the nature of post-marketing oversight.

The functional definition of medicinal productsFootnote 19 captures substances that “modify physiological functions by exerting a pharmacological, immunological, or metabolic action.” This formulation creates a degree of overlap with food supplements,Footnote 20 which under Directive 2002/46/EC may also exert “physiological effects.” The decisive element is whether the physiological effect is “significant,” yet this threshold remains undefined in EU legislation.Footnote 21

In practice, this conceptual distinction is often difficult to apply. For example, Hypericum perforatum (St John’s Wort), which contains active compounds such as hypericin and hyperforin with well-documented effects on neurotransmitter pathways,Footnote 22 illustrates the difficulty. Depending on its presentation and intended use, the same botanical preparation may be brought to market as a food supplement or regulated as a medicinal product. In the former case, the product is subject to relatively limited pre-market scrutiny, whereas in the latter it must satisfy the stringent safety and efficacy requirements of medicinal product authorisation. Although the botanical and its chemical constituents remain unchanged, the resulting regulatory obligations differ substantially. This demonstrates how classification outcomes may depend more on regulatory form and presentation than on the underlying pharmacological properties of the substance.

A central difficulty in this area arises from the functional definition of medicinal products in Directive 2001/83/EC, which encompasses substances capable of modifying physiological functions. In Commission v Germany, the Court of Justice held that the assessment must consider whether the effects of a product are of a degree that justifies classification as medicinal, but the judgment did not establish a quantitative threshold for determining when those effects become sufficiently pronounced.Footnote 23 This open formulation gives national authorities discretion and has contributed to differing national outcomes in borderline botanical cases. The Court refined its approach in Hecht-Pharma, clarifying that a product cannot fall within medicines law, solely because it may present risks when consumed in excessive quantities.Footnote 24 This prevents medicinal law from expanding based on hypothetical or dose-dependent risks, otherwise many ordinary foods could be classified as medicines. Rather than creating a regulatory gap, the ruling delineates the limits of the medicinal category. The practical difficulty arises because products that fall on the “food” side of this boundary remain subject to food-law monitoring mechanisms, which are less developed than pharmacovigilance. As a result, divergent national interpretations of these borderline cases have heightened consequences for consumer protection, not because of the Court’s reasoning, but because of the uneven strength of post-market oversight under food law.

In addition, the non-cumulation principle, which is meant to avoid overlap, has, in fact, made legal interpretations more critical.Footnote 25 This principle forces an either/or approach that fails to acknowledge the spectrum of physiological effects botanicals may exhibit. The consequences of this function-dictated fate extend beyond theoretical legal debates. For manufacturers, classification determines marketing strategies, product development and investment decisions. For consumers, the distinction between “supporting normal function” (health claim) and “treating dysfunction” (medicinal claim) becomes indistinct in real-world contexts, potentially leading to inappropriate self-medication or delayed medical treatment. For regulators, enforcing consistent standards across the internal market becomes increasingly challenging as national interpretations diverge.

Recent regulatory developments, such as Commission Regulation (EU) 2024/2041 regarding monacolin K in red yeast rice, demonstrate ongoing efforts to address these boundary issues on a case-by-case basis.Footnote 26 However, these piecemeal solutions fail to resolve the fundamental tension in the EU’s function-based approach to classification. Until clearer, science-based criteria for distinguishing between nutritional and medicinal functions are established, the regulatory inconsistency will persist.

3. When compliance becomes a cost: regulatory divergence and its impact on market access

The absence of harmonised EU rules for botanical supplements generates not only legal uncertainty but also considerable economic burdens, particularly for small and medium-sized enterprises (SMEs), which constitute the predominant actors in this sector. These operators typically lack extensive compliance departments yet must nevertheless adapt to divergent national requirements in each Member State in which they intend to market their products. This unequal regulatory landscape, combined with the variable and often unpredictable compliance costs associated with managing botanical products, undermines fair competition across the internal market and creates substantial barriers to market entry for SMEs.Footnote 27

In addition, producers of food supplements face a peculiar challenge: their products are legally sold but cannot be advertised for any meaningful use unless claims are scientifically validated; that is something most SMEs cannot afford to prove. This creates a situation where it may seem that products are either foolishly regulated or effectively prevented from communicating their inherent value to consumers, despite being legally permitted in the market.Footnote 28

For example, France maintains a comprehensive regulatory framework for Withania somnifera (Ashwagandha) that requires strict pre-market authorisation and post-market monitoring. Rather than setting quantitative limits, France subjects ashwagandha to post-market nutrivigilance.Footnote 29 In contrast, Poland adopts a more relaxed approach by relying on notification procedures alongside predefined conditions of use, maximum levels in dietary supplements and recommended markings, including warnings.Footnote 30 These differences increase the legal burden for companies trying to sell the same product across the EU. They must adapt to each country’s system, different product notifications and specific conditions, which means multiple packaging types and legal consultations, all of which cost time and money.Footnote 31

A recent study estimates that companies dealing with fragmented EU rules face about 10–15% higher compliance costs than those operating within harmonised national systems.Footnote 32 In this case updated sector-wide data remains limited; a 2010 economic analysis still referenced reported that a single rejected health claim can cost a firm up to €120,000 in reformulation, legal and re-labelling expenses, with annual sector-wide losses reaching €4.5–7.6 million.Footnote 33 The regulatory divergence could shrink the “other substances” segment of the EU supplement market by 25%. That is a potential manufacturing loss of €645 million, or over €1 billion in retail value.Footnote 34 This not only discourages companies from expanding across borders and investing in new productsFootnote 35 but may also lead to a loss of more than 13,000 jobs in this sector, roughly 18% of total employment.Footnote 36

III. Botanical safety monitoring mechanisms and their limitations

This section examines the weaknesses in EU mechanisms for monitoring the safety of botanical supplements, highlighting gaps in both pre-market assessments and post-market surveillance, and comparing these with the more developed pharmacovigilance system for medicines.

1. Where risk begins before regulation: what pre-market assessments fail to catch

Unlike medicinal products, which must pass through structured clinical testing before entering the European market, botanical supplements are subject to no centralised, harmonised pre-market authorisation regime. Under Regulation (EC) No 178/2002, since food supplements are categorised as food, the manufacturer, importer, supplier, or distributor must guarantee the safety of any food supplement introduced to the market.Footnote 37 Having said that, what constitutes “sufficient evidence” of safety remains undefined, and in practice, oversight of compliance is inconsistent across Member States. The absence of detailed, binding toxicological criteria for botanical supplements is particularly notable.Footnote 38

Subsequently, to help authorities monitor food supplements (Article 10 of Directive 2002/46/EC) more effectively, each EU Member State can require that before or at the time a food supplement is sold in that country, the manufacturer or distributor must notify the country’s competent authority (usually a food safety or health agency or office) and submit a copy of the product label (i.e., the packaging or labelling that consumers will see). This measure allows national authorities to keep track of what food supplements are being sold in their country, check the label for compliance with EU and national laws (e.g., no unauthorised health claims, proper ingredient listing), and act quickly if there is a safety concern or misleading information. The Directive leaves it to each Member State to decide whether to introduce such a system, and many, including France, Italy and Germany, have chosen to make notification a mandatory condition for market access. In those Member States that have adopted a notification requirement, compliance is not optional for operators. Divergence therefore arises not from discretionary compliance within national systems, but from the Member States’ regulatory choice under Article 10 to introduce (or not introduce) a notification procedure, resulting in uneven oversight across the Union.

Even at the EU level, attempts to guide risk assessment for botanicals reveal how much is left to individual interpretation. EFSA, for instance, has offered a tiered framework to help evaluate the safety of botanicals, taking into account factors like traditional use, available toxicological data and chemical composition.Footnote 39 But this is just guidance, and there is no legal obligation for Member States to apply it, and in practice, the extent to which it shapes national procedures varies widely. Similarly, EFSA’s Compendium of Botanicals lists plants that might raise safety concerns, but it stops short of setting hard limits on their use.Footnote 40 As a result, products containing flagged ingredients can still enter the market if their labels do not make unauthorised health claims. This patchwork approach also leans heavily on the assumption that a plant’s historical use equals safety, an assumption that does not always hold up.

A further limitation arises from the dependence on traditional-use data as an indicator of safety. Although historical consumption patterns may provide preliminary context, they are an inadequate substitute for systematic safety assessment where contemporary formulations, such as concentrated extracts, isolated active constituents, or fortified preparations, differ substantially from their conventional counterparts.Footnote 41 These modern products frequently lack comprehensive toxicological characterisation, and established assessment tools, including the No Observed Adverse Effect Level (NOAEL) and the Threshold of Toxicological Concern (TTC), are often ill-suited to evaluate the complex and variable composition of botanical matrices.

The expansion of cross-border online retail further complicates oversight. Consumers may purchase food supplements from jurisdictions where no notification or pre-market scrutiny is required, including products that would be subject to stricter conditions or even prescription status in their own member state. Digital marketplaces often operate with limited regulatory control, enabling products that are restricted or closely regulated in one Member State to become accessible to consumers in another through online channels.

2. Where reactive oversight fails: what post-market systems miss

Once botanical supplements reach the market, the European Union primarily relies on post-market surveillance mechanisms to monitor product safety, with some EU Member States implementing their own national nutrivigilance systems to address specific gaps.Footnote 42 The main tool of this approach is the Rapid Alert System for Food and Feed (RASFF), formalised under Article 50 of Regulation (EC) No 178/2002 and supported administratively by the Alert and Cooperation Network (ACN).Footnote 43 Initially established in 1979 and expanded over time, RASFF enables the swift exchange of information between Member States concerning food-related safety risks, facilitating measures such as product withdrawals, recalls, or public health warnings.Footnote 44

In principle, RASFF is designed to ensure coordinated regulatory action when risks are identified, but its effectiveness is limited by its reactive nature. In practice, the system typically requires a triggering event such as contamination, hospitalisation, or a public health concern before any notification is circulated. This is particularly problematic for botanical supplements, as this makes early intervention difficult, especially for chronic or delayed health effects. The legal framework mandates different levels of RASFF notifications based on risk severity and required actions. As a result, the classification and handling of various risks involve discretion by each country.Footnote 45 This discretionary power creates inconsistency, as national authorities interpret and apply the system differently, resulting in fragmented responses across the EU.

Rodriguez Fuentes (2017) points out, “There is no formal obligation to consult businesses affected by an alert prior to its dissemination, nor is there a structured dispute resolution mechanism when Member States disagree over the classification or severity of a risk.”Footnote 46 This lack of procedural clarity can lead to delayed action or, conversely, overcautious regulatory measures. The Bowland Dairy case shows how conflicting interpretations within the RASFF network can create serious uncertainty for businesses. Although the UK Food Standards Agency had cleared the product, the European Commission circulated a separate comment expressing disagreement. The Court upheld the Commission’s right to share its view, even though the mixed messaging led to significant business losses.Footnote 47 As Lawless points out, this kind of “destabilisation” in food risk communication reduces the system’s reliability and coordination.Footnote 48

Between 2020 and 2025, RASFF logged 1707 notifications in its “dietetic foods, food supplements, and fortified foods” category. Of these, 629 were classified as serious, 520 as potential risk, 99 as non-serious, 28 had no risk, and the remaining were left undecided.Footnote 49 Nearly all of these alerts concerned acute product composition breaches (e.g., excessive zinc or THC levels, unauthorised botanicals, or labelling fraud) rather than true consumer health events. This gulf in numbers illustrates two things. First, while RASFF is highly effective at uncovering acute compliance violations, it remains reactive, waiting for a clear “hazard” like contamination or unauthorised compounds before it triggers an alert. Second, its focus on composition-based risks leaves a blind spot for the chronic, cumulative, or delayed adverse effects that often accompany long-term botanical supplement use.

In short, despite a high volume of post-market alerts, RASFF is not a substitute for a structured nutrivigilance system capable of capturing real-world health signals over time. It has been noted that it was never intended to operate as a nutrivigilance system and should not be expected to function as one.Footnote 50 The system was originally designed for immediate food safety concerns, not for tracking the gradual emergence of adverse effects characteristic of many botanical ingredients. National nutrivigilance data shows this gap clearly. For example, in France, the food safety agency (ANSES) recorded over 200 cases of adverse effects from food supplements between 2009 and 2019, but none of these cases led to a RASFF alert.Footnote 51

A separate and more informal system is the Emerging Risks Exchange Network (EREN), coordinated by the European Food Safety Authority (EFSA). Unlike other EU food safety tools, EREN is not based on legislation and does not have any legal power. Instead, it brings together national experts to share information about new or unusual risks that may affect food safety.Footnote 52 In recent years, EREN has raised early warnings about several botanical supplements. These include possible liver damage linked to turmeric (Curcuma spp.) products,Footnote 53 questions about the safety of CBD-based foods,Footnote 54 and concerns over toxic compounds like heavy metals and oxalates found in Chaga mushroom supplements.Footnote 55 Although these issues were discussed in meetings and flagged for attention, none of them triggered official safety alerts or EU-wide action through systems like RASFF. This shows a clear weakness in the current setup: EREN may help spot problems early, but it cannot track real-world health effects or make sure products are removed from the market. It supports awareness but does not, in itself, mandate or coordinate regulatory action.

In summary, both RASFF and EREN contribute to the early identification of safety concerns and facilitate information exchange among competent authorities. However, neither mechanism provides the European Union with a coherent or systematic means of tracking real-world adverse health effects associated with botanical supplements.Footnote 56 These systems serve primarily as platforms for signalling potential issues, but they lack the institutional tools required for structured follow-up, coordinated investigation and consistent action once a concern has been identified.

3. Where pharmacovigilance ends and nutrivigilance fails to begin: what botanicals are missing

Pharmacovigilance is one of the most established post-market safety monitoring systems in the European Union. It provides a formal, legally binding framework for the collection, evaluation and management of adverse reactions to authorised medicinal products. The system operates on a centralised architecture involving marketing authorisation holders, national competent authorities and the European Medicines Agency. A central feature is the EU-wide database EudraVigilance, which receives adverse reaction reports from companies, healthcare professionals and patients. The system enables regulatory interventions such as label updates, safety warnings, product recalls and market withdrawals. Oversight is further supported by the Pharmacovigilance Risk Assessment Committee (PRAC), which coordinates signal detection and recommends risk-management measures. Together, these mechanisms create a structured and continuous form of post-market surveillance.Footnote 57

The contrast with the position of botanical food supplements is pronounced. Nutrivigilance is neither harmonised nor mandatory at the EU level. No centralised legal instrument obliges manufacturers, distributors, healthcare professionals or consumers to report adverse effects associated with food supplements. Member States may establish their own reporting schemes,Footnote 58 but where such schemes exist, they differ significantly in scope, reporting obligations, data standards and transparency.Footnote 59

Under pharmacovigilance law, marketing authorisation holders are legally required to report adverse drug reactions (ADRs) within specified timelines, and Member States must encourage and facilitate reporting by healthcare professionals and patients.Footnote 60 By contrast, adverse event reporting for food supplements is generally voluntary, varies considerably between Member States and lacks common causality assessment methodologies. There is also no EU-level body comparable to PRAC mandated to review safety data or coordinate regulatory responses in the food sector.Footnote 61

Although underreporting is a recognised limitation in pharmacovigilance systems, these systems nevertheless generate substantially more structured safety information than any existing food-supplement mechanism. This is because pharmacovigilance is characterised by legally binding reporting duties, harmonised assessment tools, centralised data management and coordinated EU-level evaluation. A proposed EU-level nutrivigilance framework would not eliminate underreporting, an inherent feature of all spontaneous reporting systems, but it would create, for the first time, a coherent structure for adverse event detection, data consolidation and cross-border coordination for botanical supplements. Even if reporting rates remained imperfect, the existence of uniform obligations, standardised assessment and a central database would significantly improve the completeness, comparability and regulatory usability of the data that are reported.

IV. Concluding remarks

The regulatory position of botanical supplements continues to expose structural weaknesses within the existing framework of EU food law. Their proximity to both food and medicinal products means that the level of safety oversight depends less on the characteristics of the preparation and more on the regulatory pathway chosen by operators or assigned by national authorities. As long as classification outcomes and procedural safeguards differ across Member States, a comparable standard of consumer protection cannot be achieved.

Introducing a harmonised pre-market notification requirement for botanical preparations would represent a proportionate and coherent legal measure. This mechanism would not amount to prior authorisation and would not replicate the schemes applicable to medicinal products. Its purpose would be to provide competent authorities with systematic visibility of products before they reach the market, and to reduce the present dependence on ex post detection through inspections or RASFF alerts. Notification requirements of this type already exist in several Member States. Extending them across the Union would not create excessive compliance burdens, including for small and medium-sized enterprises.

A second improvement concerns post-market surveillance. At present, adverse effects associated with botanicals are reported, where they are reported at all, through diverse national nutrivigilance systems. The absence of an EU-level framework results in inconsistent reporting incentives, divergent causality assessments and very limited information exchange. Establishing a coordinated surveillance system, inspired by pharmacovigilance in terms of structure but rooted in food-law principles, would not eliminate underreporting. Underreporting affects all spontaneous reporting systems. However, it would ensure that the information that is collected is assessed according to common criteria and consolidated at Union level. This would allow the identification of emerging safety signals with considerably greater reliability than is possible under current arrangements.

Resolving what may be described as the botanical puzzle does not require the creation of exhaustive definitions or centralised authorisation dossiers for every plant. What is required is a clearer and more coherent set of procedural safeguards that apply before and after products are placed on the market. A balanced approach of this kind, which preserves space for innovation while strengthening transparency and traceability, would support the functioning of the internal market and offer consumers a more even level of protection throughout the European Union.

Competing interests

The author has no conflicts of interest to declare.

References

1 The 1993 report described kidney failure cases linked to a slimming product meant to contain Stephania tetrandra. It was only later found in the 2000 report that a manufacturing error led to its substitution with Aristolochia fangchi: the actual source of toxic aristolochic acids. J L Vanherweghem and others, “Rapidly Progressive Interstitial Renal Fibrosis in Young Women: Association with a Slimming Regimen Including Chinese Herbs” (1993) 341 Lancet 387; J L Nortier and others, “Urothelial Carcinoma Associated with the Use of a Chinese Herb (Aristolochia fangchi)” (2000) 342 New England Journal of Medicine 1686.

2 V Silano and others, “Regulations Applicable to Plant Food Supplements and Related Products in the European Union” (2011) 2 Food & Function 710, <https://doi.org/10.1039/C1FO10105F>.

3 A De Boer and others, “Governance of Nutrivigilance in the Netherlands: Reporting Adverse Events of Non-Registered Products” (2022) 126 Health Policy 731–7; J T Dwyer, “Have Safety and Efficacy Assessments of Bioactives Come of Age?” (2023) 89 Molecular Aspects of Medicine 101103.

4 EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), “Guidance on Safety Assessment of Botanicals and Botanical Preparations Intended for Use as Ingredients in Food Supplements” (2009) 7 EFSA Journal 1249, 15–16, <https://doi.org/10.2903/j.efsa.2009.1249>.

5 V J Navarro and others, “Liver Injury from Herbal and Dietary Supplements” (2017) 65 Hepatology 363373.

6 F Colombo and others, “Adverse Effects to Food Supplements Containing Botanical Ingredients” (2020) 72 Journal of Functional Foods 103990.

7 Italy’s phytovigilance system began in 2002 under the Istituto Superiore di Sanità and became a national monitoring programme under the Ministry of Health in 2012, tracking adverse reactions to food supplements and herbal products (excluding traditional herbal medicines under pharmacovigilance), with reports submitted via the VigiErbe portal. Istituto Superiore di Sanità, “Fitosorveglianza” <https://www.epicentro.iss.it/fitosorveglianza/>.

8 Regulation (EC) No 1924/2006 establishes the EU framework for nutrition and health claims. Article 13(1) permits claims about a substance’s role in normal bodily functions if based on generally accepted scientific evidence and easily understood by consumers. Claims based solely on traditional use, particularly for botanicals, remain unauthorised by EFSA, leaving more than 1500 claims “on hold.” See European Food Safety Authority, “Health Claims (Art 13)” (2025) <https://www.efsa.europa.eu/en/topics/health-claims-art-13> (accessed 22 August 2025). Article 28(5) allows claims submitted under Article 13(1)(a) to remain on the market until the Commission adopts the official EU list, provided they comply with the Regulation and national rules, explaining why botanical supplements may still carry health-related statements despite lacking formal EFSA approval. See also 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 [2006] OJ L404/9 <https://data.europa.eu/eli/reg/2006/1924/oj>.

9 A R Bilia and M Do Céu Costa, “Medicinal Plants and their Preparations in the European Market: Why Has the Harmonization Failed? The Cases of St. John’s Wort, Valerian, Ginkgo, Ginseng, and Green Tea” (2021) 81 Phytomedicine 153421 <https://doi.org/10.1016/j.phymed.2020.153421>; Silano (n 2).

10 On the definition of botanicals, see A Singh, “Bursting Maze of Definition Bubbles: What Defines Plants with Beneficial Properties in EU Food Law?” (2025) Rivista di diritto alimentare Anno XIX, Quaderno n.2.

11 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2002] OJ L31/1, last consolidated version <https://data.europa.eu/eli/reg/2002/178/2024-07-01>.

12 The precautionary principle in Article 7(1) of Regulation 178/2002 allows provisional regulatory action where scientific uncertainty about potential harm remains. However, it is not a licence to act on mere doubt: measures must be proportionate, limited to what is necessary to protect health, and compatible with internal market principles. In Commission v Denmark (C-192/01), the Court of Justice clarified that such action requires a sound risk assessment followed by residual uncertainty, not hypothetical risks. See also J Vavrečka and N Grmelová, “Key Topics Discussed at the Workshop on Borderline Products on the EU’s Internal Market” (2017) 12 European Food & Feed Law Review 252.

13 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements [2002] OJ L183/51, last consolidated version <https://data.europa.eu/eli/dir/2002/46/2024-07-17>.

14 Regulation (EC) No 1924/2006 (n 8).

15 In the EU, enforcement of botanical health claims varies widely across countries despite a common legal framework. A 2021 study in Public Health Nutrition reported that 80.3% of function claims for food supplements on Spanish radio were unauthorised by EFSA, illustrating a permissive approach in some markets. See: C Muela-Molina, S Perelló-Oliver and A García-Arranz, “False and Misleading Health-Related Claims in Food Supplements on Spanish Radio: An Analysis from a European Regulatory Framework” (2021) 24 Public Health Nutrition 5156–65.

16 Denmark bans ashwagandha in supplements, France requires warning labels, and other Member States impose varying restrictions. This fragmentation results from the EU’s unresolved assessment of thousands of botanical health claims, forcing Member States to adopt their own interim measures. See: Centre for the Promotion of Imports from Developing Countries (CBI), The European Market Potential for Natural Ingredients for Stress & Anxiety Products (Ministry of Foreign Affairs, Netherlands, 11 November 2024) <https://www.cbi.eu/market-information/natural-ingredients-health-products/stress-anxiety-products/market-potential>.

17 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods [2015] OJ L327/1, Article 3(2)(a).

18 V Paganizza, “Farming Innovation: Botanicals, Novel Food Notification and the Concept of ‘Derived from Primary Production’” (2025) XIX Rivista di diritto alimentare, Quaderno 2, 52, who argues that the Novel Food Regulation introduces a “paradox of progress,” where technological refinement rather than toxicological concern becomes the trigger for regulation. The author critiques the regulation for privileging historical usage over scientific risk evaluation, noting that exemptions for traditional products rest on assumptions rather than systematic safety data.

19 Medicinal products, defined in Directive 2001/83/EC, Article 1, par. 2, (a) and (b), on the other hand as «(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis». See: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Art 1(2)(a)–(b).

20 Under EU law, the classification of a product as a food supplement or a medicinal product is not just semantic. It fundamentally determines the level of regulatory scrutiny. Food supplement defined in Directive 2002/46/EC, Art. 2, (a) as “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.” See: Directive 2002/46/EC, Art. 2(a).

21 Bilia and Costa (n 9).

22 M Schmidt and V Butterweck, “The Mechanisms of Action of St John’s Wort: An Update” (2015) 165 Wiener Medizinische Wochenschrift 229–35.

23 Case C-319/05 Commission v Germany [2007] ECR I-9811, ECLI:EU:C:2007:678.

24 The Court held that a product’s classification as a medicinal product must be determined on a case-by-case basis, considering all its characteristics, particularly its composition, pharmacological properties, manner of use, extent of distribution, familiarity to consumers and risks of use. See Joined Cases C-211/03, C-299/03, C-316/03 to C-318/03 HLH Warenvertriebs GmbH and Orthica BV v Germany [2005] ECR I-5141, ECLI:EU:C:2005:370.

25 The non-cumulation principle is derived from the Court of Justice’s interpretation of EU law, particularly in cases such as HLH Warenvertriebs (C-211/03) and Orthica BV (C-299/03 and C-316/03 to C-318/03) v Bundesrepublik Deutschland, where the Court held that a product cannot simultaneously be classified as both a food and a medicinal product. The principle, grounded in Art. 2(2) of Regulation (EC) No 178/2002, excludes medicinal products from the definition of food. See B M van der Meulen, “The System of Food Law in the European Union” (2009) 14 Deakin Law Review 305–39; Silano (n 2).

26 Commission Regulation (EU) 2024/2041 of 29 July 2024 amending Regulation (EU) No 432/2012 as regards the health claim on monacolin K from red yeast rice [2024] OJ L, 30.7.2024, C/2024/5349 <https://data.europa.eu/eli/reg/2024/2041/oj>.

27 N Grmelová and J Vavrečka, “Food Supplements on the EU Market: Illegitimate, Incapable of Being Offered or Foolishly Regulated Products?” in the 9th International Days of Statistics and Economics (Prague, 2015) pp. 487–97.

28 Ibid.

29 P Champy and others, ANSES Opinion on the Risks Associated with the Use of Withania somnifera (L.) Dunal Preparations in Food Supplements (ANSES Scientific Publication, 2024); German Federal Institute for Risk Assessment (BfR), “Ashwagandha: food supplements with potential health risks”, Communication No 039/2024, 10 September 2024 <https://www.bfr.bund.de/cm/349/ashwagandha-food-supplements-with-potential-health-risks.pdf>.

30 Sanitary and Epidemiological Council (Poland), “Summary of resolutions of the Dietary Supplements Team: maximum levels of plant ingredients and other ingredients exhibiting nutritional and/or physiological effects in dietary supplements”, Resolution No 7/2020 <https://www.gov.pl/attachment/7f475f81-7a77-42d3-a614-c9b87dcb6ff1>.

31 J Vavrečka and N Grmelová, “Key Topics Discussed at the Workshop on Borderline Products on the EU’s Internal Market” (2017) 12 European Food & Feed Law Review 252.

32 R Warda, K Purnhagen and M Molitorisová, “Has Mutual Recognition in the EU Failed?—A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and other Bioactive Substances” (2024) 47 Journal of Consumer Policy 425–43.

33 G Brookes, Economic Impact Assessment of the European Union (EU)’s Nutrition & Health Claims Regulation on the EU Food Supplement Sector and Market (European Health Claims Alliance, 2010).

34 Ibid.

35 S Bröring, S Khedkar and S Ciliberti, “Reviewing the Nutrition and Health Claims Regulation (EC) No 1924/2006: What do we Know about Its Challenges and Potential Impact on Innovation?” (2017) 68 International Journal of Food Sciences and Nutrition 1–9.

36 Though this data is over a decade old, it remains one of the few comprehensive employment analyses in this sector and continues to be referenced in policy discussions. See Brookes (n 33).

37 European Food Safety Authority, “Food supplements” (2025) <https://www.efsa.europa.eu/en/topics/topic/food-supplements#milestones>.

38 R Warda, K Purnhagen and M Molitorisová, “Has Mutual Recognition in the EU Failed? —A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and other Bioactive Substances” (2024) 47 Journal of Consumer Policy 425.

39 EFSA Scientific Committee, “Guidance on Safety Assessment of Botanicals and Botanical Preparations Intended for use as Ingredients in Food Supplements” (2009) 7 EFSA Journal 1249.

40 European Food Safety Authority, “Compendium of Botanicals Reported to Contain Naturally Occurring Substances of Possible Concern for Human Health When Used in Food and Food Supplements” (2012) 10 EFSA Journal 2663.

41 B Schilter et al., “Guidance for the Safety Assessment of Botanicals and Botanical Preparations for Use in Food and Food Supplements” (2003) 41 Food and Chemical Toxicology 1625.

42 Various EU Member States have established their own nutrivigilance systems to monitor adverse effects associated with food supplements, including Italy (2002), France (2009), Denmark (2013), Portugal (2014), Czech Republic (2015), Slovenia (2016), Croatia (2020), Belgium (2024) and Hungary (2024). These systems are analyzed in detail in A Singh, “Is Advanced Nutrivigilance a Missing Piece in the EU’s Botanical Supplement Safety Puzzle?” (FirstView, 2025) European Journal of Risk Regulation 1–16 <https://doi.org/10.1017/err.2025.10068>.

43 The Alert and Cooperation Network (ACN), established by Regulation (EU) 2017/625, facilitates administrative cooperation among national authorities overseeing the agri-food chain. It comprises information-sharing systems including the Rapid Alert System for Food and Feed (RASFF), Administrative Assistance and Cooperation Network (AAC), Agri-Food Fraud Network (FFN), and Plant Health Network (PHN). However, the ACN does not provide surveillance specific to food supplements; components like the AAC and FFN focus on regulatory compliance and fraud detection rather than health risk monitoring or adverse event reporting for botanicals, see: European Commission, “The Alert and Cooperation Network (ACN)” <https://food.ec.europa.eu/food-safety/acn_en>.

44 European Commission, “Rapid Alert System for Food and Feed” <https://food.ec.europa.eu/food-safety/rasff_en>.

45 The RASFF system categorises notifications by risk severity and required action: “alert notifications” (Art. 17) require rapid action within 48 hours for serious risks; “information notifications” (Art. 18) cover risks not requiring immediate action; “border rejection notifications” (Art. 20) apply to contaminated products barred from entering the EU; and “news notifications” (Art. 19) share safety information without requiring action. See: Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) [2019] OJ L261/37–96.

46 VR Fuentes, “The Rapid Alert System for Food and Feed—A Critical Approach” (2017) 12 European Food & Feed Law Review 121.

47 In this case, the UK Food Standards Agency lifted a RASFF alert after concluding that Bowland’s cheese was safe. Before doing so, it shared a draft with the European Commission, which disagreed and issued its own comment via the RASFF system, warning that milk safety had not been sufficiently demonstrated. Bowland Dairy argued this comment unlawfully harmed its commercial interests, but the Court held that the Commission, as part of the alert network, was entitled to issue its own scientific opinion. The judgment highlighted the potential for confusion within the alert system but found no legal breach. See Case T-212/06 Bowland Dairy Products Ltd v Commission [2009] ECR II-4073.

48 J Lawless, “Conflicting Notifications in the EU’s Rapid Alert System for Food and Feed (RASFF): ‘Destabilization’ in Food Risk Communication?” (2011) 6 European Food and Feed Law Review 240.

49 Data retrieved from RASFF Window, a public database providing summary information from the RASFF notifications. Search parameters: Date range: 1 January 2020, to 18 January 2025; Countries notifying: all; Notification type: food; Notification status: both EC validated and Withdrawn; Product category: dietetic foods, food supplements, and fortified foods; Risk: all hazard categories and risk decisions. <https://webgate.ec.europa.eu/rasff-window/screen/search> (accessed 18 January 2025).

50 G Vo Van Regnault et al., “The Need for European Harmonization of Nutrivigilance in a Public Health Perspective: A Comprehensive Review” (2022) 62 Critical Reviews in Food Science and Nutrition 8230.

51 Ibid.

52 The Emerging Risks Exchange Network (EREN), established by EFSA in 2010, enables EU countries, agencies, and international partners to share knowledge on emerging food and feed risks. It is not a legal authority or monitoring system, but a forum for exchanging “data, methodologies and lessons learnt.” EREN helps identify potential issues early through expert surveys, Briefing Notes, and biannual meetings. Members include EU food safety authorities, the European Commission, other EU bodies, and selected external observers. It has flagged concerns about botanicals such as turmeric, CBD supplements, and Chaga mushrooms, but lacks tools to track adverse events or enforce recalls. <https://www.efsa.europa.eu/en/science/scientific-committee-and-panels/scientific-committee>.

53 Turmeric (Curcuma spp.) is widely used as a spice and traditional remedy, but concentrated supplements may pose a risk of liver toxicity. In 2019, Italy’s phytovigilance system reported twenty-seven cases of acute hepatitis potentially linked to such supplements, which was discussed in EREN Briefing Note ID 0418. The concern stems from the possible hepatotoxic effects of curcumin and its derivatives at high, prolonged dose unlikely from normal dietary intake but relevant for supplements. See: A Ana and others, “EFSA’s Activities on Emerging Risks in 2019” (2020) 17 EFSA Journal 1924E.

54 CBD (cannabidiol) is a non-psychoactive compound from Cannabis sativa, often marketed in supplements for stress relief or sleep. EFSA identified it as an emerging risk in 2019, citing insufficient toxicological data on long-term safety, particularly at high doses. Concerns include liver toxicity, reproductive effects, and drug interactions. This was noted in EREN Briefing Note ID 0456 and highlights the risks of introducing novel bioactives without adequate safety assessment. See G Gkrintzali and others, “EFSA’s Activities on Emerging Risks in 2022” (2024) 21 EFSA Journal 8995E.

55 Chaga mushroom (Inonotus obliquus) supplements are marketed for their purported antioxidant and immune-boosting effects. In 2022, EREN raised concerns (Briefing Note ID 0462) about high levels of heavy metals (e.g. lead, cadmium) and oxalates, which may increase risks of kidney stones, renal damage, and heavy metal exposure. This illustrates how botanical ingredients can carry harmful environmental contaminants.

56 For a comprehensive discussion of the safety challenges linked to botanical supplements and a proposed EU-level nutrivigilance framework, see: Singh (n 42).

57 The EU pharmacovigilance system is established under Directive 2010/84/EU and related regulations. It provides a legal and technical framework for monitoring the safety of medicines after they are placed on the market. The system includes EudraVigilance, a central database for collecting adverse event reports, and the Pharmacovigilance Risk Assessment Committee, which evaluates risks and advises on regulatory action. European Commission, “Pharmacovigilance” <https://health.ec.europa.eu/medicinal-products/pharmacovigilance_en> (accessed 17 August 2025).

58 The EU regulatory framework includes some food safety monitoring provisions but lacks a harmonised nutrivigilance system like pharmacovigilance. Art. 12 of Directive 2002/46/EC allows Member States to suspend or restrict food supplements that may endanger health, but only as a reactive measure based on “detailed grounds,” not as part of systematic monitoring. Regulation (EC) No 178/2002 sets broader food safety rules: Arts. 8a–e define risk communication; Art. 14 sets safety requirements; Art. 17 makes businesses responsible for compliance; Article 19 obliges them to withdraw unsafe products and notify authorities; and Arts. 50–2 establish the Rapid Alert System for Food and Feed (RASFF).

59 Nutrivigilance refers to post-market monitoring of adverse effects related to food supplements. There is no EU-wide legal obligation for nutrivigilance. Each Member State decides whether to establish such a system, resulting in significant differences across the EU. For an overview, see G Vo Van Regnault and others (n 50).

60 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, pp. 67–128: Art. 102(1)(a)–(f) requires Member States to encourage and facilitate reporting of suspected ADRs by healthcare professionals and patients and allows Member States to impose specific obligations on healthcare professionals; Art. 104(1)(c) obliges marketing authorisation holders (MAHs) to record and report all suspected ADRs to competent authorities. See also Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012, OJ L 159, 20.6.2012, pp. 5–25, Art. 26, setting deadlines for MAHs (15 days for serious ADRs, 90 days for non-serious ADRs) to report via the EudraVigilance database; Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, OJ L 136, 30.4.2004, pp. 1–33, Art. 28(1), imposes equivalent obligations on MAHs of centrally authorised products.

61 EMA, “Pharmacovigilance Risk Assessment Committee (PRAC)” <https://www.ema.europa.eu/en/committees/prac>. The PRAC, established under Regulation (EC) No 726/2004, Art. 56 and Art. 61a, is responsible for the assessment and monitoring of safety issues for medicinal products. No equivalent EU-level body exists for food supplements.