I. Introduction
In the wake of my article “The Fragmented Regulatory Puzzle of So-Called Botanicals in the EU Between Food and Medicine,”Footnote 1 one conclusion becomes inescapable: the Single Market still lacks an instrument capable of systematically detecting and evaluating real-world harms linked to botanical food supplements. Even after two decades of reforms, EU food law has still not cracked the puzzle of how to deal with plants with purported healing properties that claim healing properties, often called botanicals, or sometimes borderline products, because they sit in regulatory limbo between food and medicine.Footnote 2
The problems begin at the foundational level of these products and their regulatory structure. There is no agreed definition of what a “botanical” even is, no EU-wide list of what is permitted or prohibited, and the most basic safety measures like minimum quality standards, limits on active ingredients, or standardised warnings, still vary widely from one Member State to the next.Footnote 3
In practice, that legal bricolage has produced two serious impacts. First, products that clearly act like drugs, such as high-dose monacolin-K in red-yeast-rice capsules, are being sold as foods, based largely on safety files where the burden of proof rests with the producer. Second, once these products are on the market, monitoring is inconsistent and incomplete.
To be fair, some tools do exist: RASFF flags acute or compositional problems,Footnote 4 national nutrivigilance systems in France, Italy and Belgium collect scattered reports of adverse events,Footnote 5 and EFSA’s Emerging Risks Network exchanges early signals.Footnote 6 Yet nothing at the EU level systematically links product, exposure and clinical outcomes and nothing comparable to the pharmacovigilance system in place for traditional herbal medicines.
There have been repeated signals that bear this out, from nephrotoxicity from Aristolochia adulterationFootnote 7 and hepatotoxicity from Curcuma longa extracts.Footnote 8 However, none of these incidents has triggered a coordinated EU response on the scale of the risk involved. Medicines benefit from robust pre- and post-market surveillance systems designed to identify and address adverse events. By contrast, food categories such as supplements or fortified foods with added plant ingredients lack such comprehensive safeguards.
To examine why this gap persists, this article applies a targeted textual analysis of both binding and soft-law EU instruments on botanicals, complemented by scientific literature. The key question is simple: where does the law require action that the current monitoring tools fail to deliver?
The aim of this article is not only to describe the well-known pieces of the EU’s botanical supplement puzzle, such as the missing definition of “botanical,” the unresolved health claims, or the lack of standardised safety limits, but also to draw attention to a critical dimension: the post-market safety of botanicals, which matters just as much as the debate over their benefits. Rather than stopping at a diagnosis of what is wrong with the current framework, this article focuses on one essential, though not yet sufficient, part of the solution: an EU-wide nutrivigilance system. Obviously, on its own, it cannot resolve all the challenges, but without it, the broader puzzle cannot be solved. In short, this article asks whether and how harmonised advanced nutrivigilance is indeed the missing piece in the EU’s botanical supplement safety puzzle.
II. Real-world failures cases: what happens when no one’s watching
The growing popularity of botanical supplements has highlighted serious weaknesses in the EU’s food safety system. Although the European Food Safety Authority (EFSA) made progress in 2022 by shifting towards proactive risk detection using tools like emerging risk monitoring and horizon scanning, this improvement came too late to stop real health problems from happening.Footnote 9 In fact, several past and recent incidents clearly show that gaps in pre-market evaluation, post-market surveillance, and cross-border coordination led to slow, fragmented or incomplete responses when risks appeared.
1. High-profile safety crises
One of the most devastating food safety incidents remains the so-called Aristolochia crisis of the 1990s and early 2000s. In this case, weight-loss supplements made with Chinese herbs were mistakenly contaminated with Aristolochia species plants known to be highly toxic to the kidneys and linked to cancer. As a result, hundreds of consumers suffered kidney failure and urothelial cancer, triggering a major public health scandal that revealed serious weaknesses in the EU’s pre-market safety controls. Specifically, these controls failed to detect the dangerous substitution before the products reached the market. Moreover, the Rapid Alert System for Food and Feed (RASFF) lacked the tools to specifically monitor botanical risks at the time. To make matters worse, the regulatory response was fragmented and delayed: Belgium banned these products in 2001, but other Member States only followed years later.Footnote 10 This lack of timely, coordinated action allowed the crisis to escalate across borders, leaving consumers unprotected and highlighting the urgent need for stronger, harmonised monitoring systems.
Another clear example of regulatory inconsistency involves black cohosh (Actaea racemosa), a popular botanical supplement often marketed for menopausal symptom relief. Over the years, numerous reports raised red flags about its potential to cause liver damage. Yet, rather than triggering a harmonised EU-level response, different Member States reacted in different ways, where some issued warnings, others imposed partial restrictions, and many took no formal action at all.Footnote 11 This fragmented approach to risk management delayed effective intervention, leaving consumers exposed to avoidable harm.
2. Ongoing concerns with common botanicals
Concerns continue to grow around certain botanical supplements that pose serious risks to consumer health. One prominent example involves supplements containing monacolins from red yeast rice, which are structurally identical to pharmaceutical statins. EFSA’s assessment found that even low doses, as little as 3-mg per day, may cause adverse effects such as muscle damage and liver toxicity (EFSA, 2024).Footnote 12 These findings have further complicated the regulatory challenge of striking a fair balance between market availability and consumer safety.
Further safety concerns have emerged around botanical supplements containing Hydroxyanthracene Derivatives (HADs), frequently used in herbal laxatives and related products.Footnote 13 EFSA identified strong evidence of the genotoxic and carcinogenic potential of these substances, based on in vitro and animal studies.Footnote 14 Notably, EFSA was unable to establish a safe intake level for HADs, particularly in cases of long-term consumption. In response, the European Commission adopted a formal prohibition in March 2021, banning the use of botanical preparations containing HADs in food. This decision specifically targeted substances such as emodin and aloe-emodin and resulted in the addition of various Aloe, Cassia and Rhamnus species to the restricted list under the relevant food regulation.Footnote 15
However, in a landmark ruling, the General Court overturned the European Commission’s decision to prohibit preparations derived from Aloe species containing Hydroxyanthracene Derivatives (HADs), finding that the Commission had failed to establish a clear safety threshold required by law. The Court emphasised that regulatory measures must precisely define safe levels before imposing a general prohibition.Footnote 16 Similarly, in a related judgment, the General Court annulled the inclusion of various botanical preparations containing HADs (Aloe, Cassia, Rhamnus and Rheum species) on similar grounds. The Court clarified that the Commission exceeded its authority by using broad terms like “preparations,” which cannot replace specific legally defined categories of “substances” or “ingredients” under Regulation (EC) no 1925/2006. This judgment underlines the importance of clear, consistent definitions in the EU’s food safety framework.Footnote 17
3. Suspected and hidden risks
Recent regulatory assessments have shown that even well-known, widely used plant-based supplements can carry real health risks when consumed in concentrated forms. In 2024, the Heads of European Food Safety Agencies (HoA) reviewed the safety of non-vitamin and non-mineral substances used in food supplements across the EU. Their findings were concerning. Out of 117 substances reviewed, they flagged 13 as possible-risk ingredients based on available safety data. Many of these are plants that consumers often associate with traditional health benefits, including curcumin (turmeric), piperine (black pepper), St. John’s wort (Hypericum perforatum), ashwagandha (Withania somnifera) and Tribulus terrestris. These supplements are sold openly across Member States, often promoted with health claims that suggest they are safe and beneficial. Yet, no harmonised safety assessment has been carried out at the EU level. The HoA report made clear that without binding lists of restricted or prohibited ingredients, national rules will continue to differ, leaving gaps in consumer protection.Footnote 18
Scientific studies have also pointed to another regulatory weakness: the lack of oversight over supplement–medicine interactions. Research found that certain supplements can interfere with how medicines are processed in the body. Specifically, some supplements inhibit enzymes like CYP2C9, CYP2C19, and CYP3A4, which are critical for breaking down dermatological drugs. When these enzymes are blocked, medicines can stay in the body longer or at higher levels, raising the risk of serious side effects. This is not a theoretical concern alone; Matran’s team documented real cases where patients experienced adverse skin reactions linked to supplement use. Although, such interactions remain poorly monitored under current EU rules.Footnote 19
EU pharmaceutical law requires interaction risks to be assessed during the marketing authorisation of medicinal products, including herbal medicinal products. Article 59(1)(c)(iii) of Directive 2001/83/EC obliges the package leaflet to indicate interactions “with other medicinal products and other forms of interaction (e.g., alcohol, tobacco, foodstuffs).”Footnote 20 As herbal products fall within the definition of medicinal products by presentation or by function (Article 1(2)), this obligation applies equally to herbal medicinal products. The 2010 pharmacovigilance reform further broadened the definition of “adverse reaction” to a “noxious and unintended response to a medicinal product,” extending monitoring to misuse, overdose and use beyond authorised conditions.Footnote 21
However, the ability of pharmacovigilance systems to detect interactions involving botanicals used as food supplements is structurally limited. These systems are designed to capture adverse reactions related to authorised medicinal products rather than to record exposures to co-consumed supplements. Empirical evidence supports this limitation. In Italy, analyses of reports submitted to the national phytovigilance system show that suspected reactions related to dietary supplements are frequently under-reported and inconsistently captured.Footnote 22 Likewise, Dutch pharmacovigilance data indicate that reports concerning herbal medicinal products and herbal supplements rely largely on spontaneous submissions to the national centre (Lareb), with significant variability in reporting completeness and attribution.Footnote 23
Accordingly, while EU pharmaceutical law ensures ex ante assessment of interactions for authorised herbal medicinal products, the real-world detection of herb–medicine interactions involving botanicals marketed as food supplements remains weak, owing to the reliance on spontaneous reporting frameworks outside the pharmaceutical regulatory system.
At the same time, new types of food supplements are entering the market, bringing new challenges. For example, macroalgae (seaweed) is now promoted as an alternative source of protein. However, a recent risk-benefit analysis by EFSA (2024) highlighted that certain species contain very high levels of iodine. Consuming too much iodine over time can cause thyroid problems, but this risk is rarely communicated to consumers. EFSA recommended clear, species-specific consumption guidelines to avoid unintended health risks.Footnote 24
4. Systemic risk: adulteration of “natural” botanicals
In addition to safety concerns arising from natural plant compounds, an increasing number of botanical food supplements have been found to be adulterated with undeclared pharmaceutical substances. A Dutch study revealed that nearly 48% of botanical supplements marketed for weight loss or sexual enhancement contained illegal additives such as sibutramine, sildenafil, and phenolphthalein, at levels capable of causing significant pharmacological effects.Footnote 25 Many of these products were marketed as “natural” but posed substantial risks due to the presence of potent synthetic substances. Similarly, an analysis by the Dutch Pharmacovigilance Centre, Lareb, documented 789 cases of adverse events related to herbal products over 30 years, of which 15% were serious or life-threatening. Many implicated supplements were found to contain undeclared pharmaceutical ingredients or harmful contaminants.Footnote 26 These findings expose a serious regulatory blind spot in post-market surveillance and enforcement mechanisms.
5. Beyond botanicals: the caffeine supplement incident
The risks linked to concentrated food supplements are not limited to plant-based products and their ingredients. A tragic example from the United Kingdom in 2021 exposed how dangerous gaps in regulation also apply to natural “other substances” from plant sources (chemical compounds not exactly considered botanicals), such as caffeine. In this case, a personal trainer died after consuming a powdered caffeine supplement. A simple miscalculation of the dose led him to ingest the caffeine equivalent of nearly 200 cups of coffee in a single serving. The product label listed the caffeine content in milligrams but failed to provide clear dosing instructions, a critical omission that contributed to the fatal outcome (Food Standards Agency & Food Standards Scotland, 2023).Footnote 27 While the European Food Safety Authority (EFSA) monitors caffeine intake from food and beverages across twenty-two Member States, caffeine-containing supplements fall outside its systematic surveillance activities.Footnote 28 The absence of mandatory adverse event reporting means that many similar incidents likely remain undocumented. That being said, it might leave regulators blind to emerging trends in supplement misuse.
III. National nutrivigilance systems: a patchwork of uncoordinated responses
1. The established national systems
Several Member States have developed comprehensive official nutrivigilance systems, though their legal nature differs over the past two decades. France, through its ANSES (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) system established in 2009, has perhaps the most comprehensive approach. The French system has developed sophisticated causality assessmentFootnote 29 procedures specifically adapted to food supplements, with systematic evaluation of all reported cases. Italy operates through its National Institute of Health (ISS), which recorded 1,480 reports between 2002 and mid-2020, making it one of the earliest adopters of structured nutrivigilance in Europe.
Other established systems include Denmark (73 reports), Portugal (136 reports), the Czech Republic (37 reports), Slovenia (107 reports), and Croatia (6 reports) between 2014 and 2021, though these operate with varying degrees of mandatory reporting requirements and different thresholds for intervention.Footnote 30 In some Member States that operate nutrivigilance systems, such as France, Italy and Germany, food supplements must also be notified to the national authority before they are placed on the market, as allowed by Article 10 of Directive 2002/46/EC.Footnote 31 This gives authorities an official list of products and improves the traceability of any adverse effects that are later reported. In countries without such notification procedures, authorities do not have a full picture of what products are being sold, which makes follow-up and product identification more difficult.
2. Recent mandatory developments: the Belgian case
Some Member States have recently taken concrete steps to address the monitoring of adverse effects linked to food supplements by establishing national nutrivigilance systems. For example, Belgium formalised its own nutrivigilance framework in December 2023 through two royal decrees: one on the notification of undesirable effects linked to the use of foodstuffs and one on the Nutrivigilance Commission.Footnote 32
These decrees introduced mandatory reporting obligations for food business operators concerning adverse effects linked to certain food products, including food supplements, novel foods, foods for specific groups like infants and fortified foods. This structured reporting requirement operates in addition to the general safety obligations under Article 19 of Regulation (EC) No 178/2002, which requires operators to withdraw unsafe food from the market. Importantly, while operators face mandatory reporting duties, healthcare professionals and consumers may report adverse effects voluntarily through the same system.Footnote 33 The Belgian approach aims to protect public health by creating an early-warning system similar to pharmacovigilance but specifically designed for food products.
3. The voluntary national and industry systems
a. Partial government systems
These national initiatives may offer hope that other Member States will follow suit in establishing at least their own national level nutrivigilance mechanisms. The Netherlands, for instance, does not yet have a formal nutrivigilance system. However, its Pharmacovigilance Centre, known as Lareb, does accept reports of adverse effects related to food supplements alongside medicines on a voluntary basis. Lareb has previously recommended the introduction of a structured nutrivigilance framework in the Netherlands to ensure early detection of risks linked to these products.Footnote 34
Interestingly, the Dutch Bureau of Risk Assessment & Research (BuRO) has also proposed a pre-market notification system for food supplements.Footnote 35 This would mean companies must inform authorities about their products before placing them on the market. While this system wouldn’t monitor side effects directly, it could help fill the current safety gap. By creating an official record of what is sold, it would allow regulators to keep track of supplements and make it easier to link specific products to any health problems reported later. In other words, pre-market notification could lay the groundwork for a more effective post-market nutrivigilance system in the Netherlands.
b. Industry-led voluntary initiatives
Some supplement manufacturers have recognised the importance of post-market monitoring and established voluntary nutrivigilance systems. A notable example is the initiative led by producers of red yeast rice supplements. Between 2013 and 2023, this program collected data from approximately four million users and reported serious adverse events at an exceptionally low rate of 0.0002%.Footnote 36 While such voluntary initiatives contribute useful safety data, they cannot replace a harmonised obligatory framework. Voluntary systems depend heavily on company commitment and consumer awareness, leaving significant gaps in transparency and accountability. They may work well for reputable producers but offer no protection against irresponsible actors or cross-border online sales.
c. Mixed approaches: the Hungarian case
Hungary is another Member State that recently formalised its nutrivigilance system. In 2024, the country launched an official platform to collect reports of side effects related to food supplements, named Nutrivigilancia.hu. The platform was developed collaboratively by the Hungarian Association of Dietary Supplement Manufacturers and Distributors, the University of Szeged, and Semmelweis University. It encourages consumers, healthcare professionals and manufacturers to report adverse effects of dietary supplements, defined as foods containing concentrated sources of nutrients or other substances with nutritional or physiological effects.Footnote 37
The Hungarian system represents a hybrid approach: while comprehensive in scope and professionally designed, it relies on voluntary contributions from the public, healthcare professionals and businesses rather than mandatory reporting obligations. This contrasts with Belgium’s mandatory framework and illustrates the spectrum of approaches currently emerging across Member States.
d. Academic recognition without action: the case of Poland and Romania
Several Member States demonstrate academic recognition of nutrivigilance importance without implementing formal systems. In Poland, while no dedicated nutrivigilance system currently exists, scholarly discussions have highlighted the need for harmonised monitoring of food supplement safety to fill regulatory gaps, especially given rising consumption of such products.Footnote 38
Romania similarly lacks a formal nutrivigilance system, though academic studies from Romanian researchers have consistently argued that the country should adopt nutrivigilance policies, particularly due to increasing dietary supplement consumption and associated health risks. A recent review of adverse effects linked to food supplements sold in Romania uncovered cases involving well-known botanicals such as Aloe vera, Ginkgo biloba, Echinacea, Chelidonium majus, Valeriana officinalis (valerian), Foeniculum vulgare (fennel), and Ocimum tenuiflorum (holy basil). These products were widely marketed as safe and beneficial, yet adverse reactions included liver toxicity, kidney damage, serious drug interactions and skin disorders.Footnote 39 This means that people taking these supplements alongside prescribed medications may face a much higher risk of harmful interactions. The authors concluded that, without a formal nutrivigilance system in place, such risks in Romania are likely to go unnoticed and unaddressed.
IV. The EU-level regulatory gap: sophisticated assessment without systematic surveillance
The fragmentation of national nutrivigilance systems reflects a deeper structural problem: even at the EU level, the regulatory framework combines sophisticated pre-market scientific assessment frameworkFootnote 40 with an inadequate and poorly coordinated post-market surveillance architecture. While the European Food Safety Authority (EFSA) provides independent risk assessments and the European Commission is responsible for risk management, neither institution ensures a harmonised, systematic post-market monitoring of adverse effects specifically associated with botanical food supplements. This institutional shortcoming undermines the ability of EU authorities to identify and respond to emerging risks effectively and consistently.
1. EFSA’s non-binding scientific guidance
In 2009, EFSA issued a Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, which remains a reference point for pre-market risk assessment.Footnote 41 However, this guidance lacks binding legal force, creating a disconnect between scientific methodology and regulation.Footnote 42
The guidance proposes a two-tiered scientific framework that is inherently flawed in its implementation assumptions. Level A presumes safety based on “well-documented, long-standing use in food at comparable intake levels,” while Level B requires additional toxicological data when these conditions are not met. This framework rests on the scientifically questionable assumption that historical patterns of safe use remain valid under contemporary consumption conditions, despite the prevalence of concentrated extracts, novel formulations and significantly higher dosages that characterise modern botanical supplement markets.
The critical legal gap emerges here: whether contemporary uses remain within the safety parameters presumed under Level A can only be determined through systematic post-market surveillance, yet no corresponding legal obligation exists for such monitoring. This creates a scientific framework that is operationally dependent on evidence collection mechanisms that regulators have systematically failed to establish.
2. The limitations of existing surveillance mechanisms
It would be incorrect to suggest that the European Union lacks mechanisms for post-market surveillance of food-related risks. The Rapid Alert System for Food and Feed (RASFF), established under Article 50 of Regulation (EC) No 178/2002, enables Member States, the European Commission, and EFSA to exchange information rapidly when risks to human health are identified in food or feed.Footnote 43
Data confirm that RASFF predominantly captures notifications concerning unauthorised botanicals or compositional violations. Notably, some emerging risks, such as hepatotoxicity from Curcuma supplements, safety concerns over CBD-based foods, and heavy metals and oxalates in Chaga mushroom products, were flagged through the Emerging Risks Exchange Network (EREN) but did not result in formal RASFF alerts or regulatory measures.Footnote 44
However, RASFF remains fundamentally a reactive mechanism, triggered by the detection of risks through official controls, targeted inspections, company self-reports, border checks or consumer complaints. Notifications, whether alerts, information notices, border rejections or news, must always be submitted by national competent authorities, even when the underlying detection originates from companies or consumers.
RASFF collects and analyses data on detected product hazards, but it does not function as a proactive, systematic surveillance system of health outcomes. It does not monitor adverse health effects in consumers or track long-term, cumulative harms that may result from chronic consumption of botanicals. Its notifications tend to reflect acute, identifiable risks such as microbiological, chemical or fraudulent rather than subtle or delayed effects.
According to RASFF annual reports, thousands of notifications are recorded each year, demonstrating that the system is active and continuous. Nonetheless, the detection of risks associated with botanicals remains uneven, depending on the priorities, scope, and frequency of Member State controls, which vary significantly and are not harmonised.Footnote 45
Similarly, a few countries, particularly France, Italy, and Belgium, have established national nutrivigilance systems to monitor adverse health effects of food supplements. While these initiatives represent important progress, their scope, methodologies and reporting practices vary considerably, and many Member States lack such systems altogether. In the absence of a harmonised EU-wide nutrivigilance mechanism, the Commission and EFSA must rely on fragmented and inconsistent national data, limiting their ability to assess and manage risks effectively at the Union level.
3. The article 8 evidence paradox
The Commission’s Article 8 procedure under Regulation (EC) No 1925/2006 illustrates a significant structural challenge in the EU’s botanical supplement framework. Under Article 8, the Commission may prohibit, restrict or subject to scrutiny certain substances, including botanicals, if they present potential risks to consumers at levels either exceeding or within normal dietary intake.Footnote 46 While this procedure allows both Commission-initiated assessments and Member State submissions, it relies heavily on Member States providing scientific evidence of risk that demonstrates the conditions of Article 8(1) are met.
The challenge becomes apparent when examining the evidence requirements. Commission Implementing Regulation (EU) no 307/2012 requires “generally accepted scientific evidence” to support proposed restrictions.Footnote 47 However, the EU lacks a harmonised nutrivigilance system to systematically collect adverse event data for botanical supplements. Instead, the Commission and EFSA must work with fragmented national data, adverse event reports from the few Member States with nutrivigilance systems, RASFF notifications designed for acute risks rather than chronic effects and voluntary industry submissions.
This creates a regulatory challenge that affects the framework’s effectiveness. The legal procedures assume the availability of systematic post-market safety data, yet the institutional architecture provides no harmonised mechanism specifically designed to generate such data for botanical supplements. This contrasts with the comprehensive pharmacovigilance systems that exist for medicinal products with similar bioactive profiles.
The result is that Article 8 procedures tend to be reactive rather than proactive. Without systematic adverse event monitoring, regulatory action often depends on crisis-driven national submissions or chance detection through existing surveillance tools that were not designed for this purpose. This gap between the sophistication of the EU’s pre-market scientific guidance and the available post-market surveillance infrastructure creates delays in risk detection and may limit the effective implementation of precautionary approaches under Article 7 of Regulation (EC) no 178/2002.
V. Advanced nutrivigilance: the missing piece in EU botanical supplement safety
If there is one clear lesson to draw from decades of fragmented EU governance on botanical supplements, it is that risk detection without follow-through is not enough. Despite well-intentioned guidance documents, literature reviews, and ad hoc national initiatives, the EU’s regulatory framework has consistently struggled to keep pace with the complex risks posed by botanical supplements. The root of the problem is structural: while medicinal products benefit from an integrated pharmacovigilance system, food supplements with similar bioactive profiles are monitored only sporadically, and mostly reactively, under inconsistent national frameworks.
This regulatory imbalance is not merely a technical oversight; it has real consequences. It leaves consumers exposed to preventable harm and creates legal uncertainty for responsible businesses operating across the internal market. An adverse event linked to a botanical supplement may prompt action in one Member State but go unnoticed in another, allowing products to continue circulating across borders and online marketplaces without adequate oversight.
The solution is neither to over-regulate botanical supplements as medicines nor to maintain the current fragmented approach. Instead, what is needed is a fit-for-purpose, proportionate EU-wide nutrivigilance system tailored specifically to the characteristics and risk profile of botanical supplements. Such a system would not reinvent the wheel. The regulatory architecture already exists. Articles 114 and 168 Treaty on the Functioning of the European Union (TFEU) provide a solid legal foundation to address both market functioning and public health protection. The necessary institutional expertise sits within EFSA, national authorities and the food supplement industry itself. What is missing is political commitment to connect these dots and establish a structured, mandatory framework.
1. Four pillars of a future EU nutrivigilance system
A future EU nutrivigilance system should rest on four practical pillars. First, a centralised digital reporting platform accessible to all stakeholders, like manufacturers, healthcare professionals and consumers, which allows the systematic collection of adverse events linked to botanical supplements in a harmonised format. This would build upon the proven effectiveness of national initiatives such as France’s ANSES nutrivigilance system, providing an EU-wide solution.Footnote 48
Second, mandatory reporting obligations for serious adverse events, coupled with voluntary reporting channels for non-serious incidents. This balanced approach ensures serious risks are flagged early while not overburdening the system with minor or unrelated complaints.
Third, clear and standardised causality assessment procedures, adapted to the specific challenges of botanicals that include complex mixtures, variable formulations, and interactions with medicines. Without such tools, adverse event data remains anecdotal and unusable for regulatory decision making.
Fourth, a formal mechanism to translate nutrivigilance findings into regulatory action, including temporary restrictions, updated labelling requirements, or, where warranted, adding substances to the Union list of prohibited or restricted botanicals under Regulation (EC) no 1925/2006.
Of course, this will require investment that can be technical, financial and institutional. Member States with fewer resources, particularly in Eastern and Southern Europe, may require targeted EU support to implement and maintain the system. But the costs of inaction are far higher: inconsistent market surveillance, continued exposure of consumers to unmonitored risks, and the perpetuation of a distorted internal market where compliance burdens fall unevenly across Member States.
2. Addressing Member State capacity disparities
A harmonised nutrivigilance system must also account for the differing technical and financial capacities of Member States. Research has highlighted that countries in Eastern and Southern Europe, including Romania and Poland, face structural challenges in implementing post-market surveillance systems due to limited resources. Without targeted EU support, official nutrivigilance obligations risk widening existing disparities.
To avoid this, the EU should accompany the rollout of nutrivigilance with proportionate funding mechanisms to assist Member States in establishing national contact points and reporting infrastructures. Technical assistance and training programs should be made available to ensure consistent capacity across the Union. Furthermore, digital solutions and simplified procedures would help minimise administrative burdens, particularly for small and medium-sized enterprises.
3. Incentivising industry participation
Effective nutrivigilance will also depend on the active engagement of the industry. Regulatory mandates alone may not be enough to secure timely and comprehensive reporting. Therefore, the EU should develop positive incentives for food business operators who demonstrate compliance with nutrivigilance obligations.
These incentives may include streamlined notification procedures for companies with a robust safety reporting record, priority assessment of new botanical ingredients or health claims for operators engaged in transparent risk communication, and reduced inspection frequencies for businesses with demonstrated safety compliance. This positive reinforcement approach would encourage businesses to view nutrivigilance not as a regulatory burden but as a strategic tool to build consumer trust and secure regulatory goodwill.
4. Enabling EU-wide negative or restrictive lists for botanicals supplement
One of the most persistent structural weaknesses in the current EU framework is the absence of a harmonised negative or restrictive list of high-risk botanical ingredients. At present, individual Member States maintain their own lists, leading to fragmentation, regulatory uncertainty, and disparities in consumer protection. Without such a system, these lists will remain based largely on theoretical risk assessments and historical use patterns rather than actual data on how botanical supplements impact consumers across the EU.
A structured EU nutrivigilance system would provide the real-world evidence necessary to develop and maintain such lists. Continuous collection of adverse event data would allow regulators to identify specific botanicals associated with serious or recurrent safety concerns, based on actual consumer experience rather than theoretical risks. This evidence could directly inform procedures under Article 8 of Regulation (EC) No 1925/2006, which enables the Commission to prohibit or restrict the use of substances in foods based on emerging safety concerns. Currently, the Union list under this regulation is limited and reactive.
In practical terms, this would mean that when nutrivigilance data consistently reveal serious safety concerns linked to a specific botanical, such as cases of liver toxicity, cardiovascular complications or harmful interactions with medications, the European Food Safety Authority (EFSA) would be tasked with carrying out a thorough scientific assessment of the reported risks. Based on EFSA’s opinion, the European Commission, as the competent risk manager, would then be able to adopt appropriate regulatory measures. These could include restricting the conditions of use of the botanical, setting maximum safe levels for its bioactive components, imposing mandatory warning labels, or, where warranted, adding the ingredient to the Union’s list of prohibited or restricted substances under Regulation (EC) No 1925/2006.
In short, nutrivigilance is not about adding regulatory red tape. It is about closing the most glaring gap in the EU’s food safety framework: when botanical supplements cause harm, the system does not rely on chance, national discretion or reactive crisis management to respond.
VI. Concluding remark: food for thought
The EU’s approach to botanical supplement regulation has, for too long, been defined by fragmentation, uneven enforcement, and reactive governance. This paper has demonstrated that without a harmonised post-market surveillance system, botanical supplements continue to fall between the cracks of EU food law, exposing consumers to avoidable risks and businesses to regulatory uncertainty.
More troubling, this fragmentation contradicts one of the European food law’s core promises: equal protection for all citizens within the single market. The principle that a French consumer and a Polish consumer should enjoy the same level of safety seems almost quaint when examining botanical supplement oversight. France operates systematic nutrivigilance. Other Member States rely on fragmented reporting or no systematic monitoring at all.
The EU has built a sophisticated pre-market risk assessment framework for botanicals, supported by scientific guidance and formal procedures. Unfortunately, it has failed to complement this with equally robust post-market surveillance. Existing tools such as RASFF, though valuable, remain reactive and poorly suited to the chronic and cumulative nature of many risks associated with botanical supplements. This creates a critical imbalance: the system demands strong evidence of harm to justify restrictions but provides no systematic means of collecting that evidence.
Modern problems demand modern solutions: the EU urgently needs an advanced nutrivigilance system with fully integrated digital infrastructure. This requires establishing mandatory reporting obligations, standardised causality assessment procedures, and enforceable regulatory follow-up mechanisms. Only through these measures can the EU shift from reactive crisis management to systematic, evidence-based prevention.
This system should not replicate existing fragmented databases but should function as a centralised botanical safety hub, linking all Member States, EFSA, RASFF and relevant EU institutions. User-friendly, dynamic and searchable. The platform should move beyond static Portable Document Format (PDF) uploads to provide real-time regulatory intelligence. It must consolidate adverse event reports, stakeholder inputs, regulatory actions, safety guidelines, applicable legislation, scientific literature and ongoing court proceedings (including case filings, procedural updates and judgments). Automated inquiry tools could offer the public clear, accessible information about the safety status of botanicals, reducing misinformation and confusion.
The current database system forces regulators, researchers and business operators to navigate multiple disconnected and incomplete data sources. This leads to critical knowledge gaps, delays in risk management, and wasted time and energy just to find and collect these resources. This inefficiency should no longer be acceptable in a sector where consumer trust and health protection are top priorities. A coordinated, integrated platform would also enable scientific specialists, including toxicologists, nutritionists and pharmacologists, to identify botanicals requiring immediate research prioritisation. Many times, EFSA encounters insufficient data during safety assessments, particularly for botanicals with complex matrices and multiple bioactive compounds. Systematic data aggregation would allow researchers to target which compounds warrant laboratory investigation, optimise the use of limited resources and facilitate interdisciplinary collaboration to uncover potential or hidden risks.
The legal basis is clear, the technical capacity exists, and several Member States have shown that nutrivigilance is feasible. What remains is the political will to connect these pieces to fill the most obvious void in the EU’s food safety framework. The time to act is now. The question that remains is whether EU regulators will seize this opportunity to future-proof the governance of botanical supplements or whether they will wait, once again, for the next avoidable crisis to force their hand. Only through this advanced nutrivigilance approach can botanical products remain both accessible to consumers and equally safe across all twenty-seven Member States.
Acknowledgments
This study was carried out within the BEETROOT project (“Building a comprehensive regulatory framework for plants with healing properties and botanicals, used as food, to boost public health”) and received funding from the European Union Next-GenerationEU (Missione 4 “Istruzione e Ricerca,” componente 2 – investimento 1.1, Fondo per il Programma Nazionale di Ricerca e Progetti di Rilevante Interesse Nazionale – PRIN), MUR code P2022TSH95, Cambridge University Press C53D23009970001. The views expressed in this article are solely those of the author.
Competing interests
The author has no conflicts of interest to declare.
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