The medicalisation of animal health
As animal health shifts toward pharma and biotech-driven interventions, basic determinants like nutrition are being sidelined—despite their immense impact on both healthspan and lifespan
FEATURE – The European siege on botanicals: why we must combat the latest EU anti-botanical push
Behind closed doors in Brussels, EU regulators are shifting from risk management to risk elimination — putting dozens of widely used botanicals at risk of restriction based on theoretical hazards rather than real-world science.
In this article
By Rob Verkerk PhD, founder, executive & scientific director
Plant compounds represent the longest-standing and most important tools in medicine for almost the entirety of human evolution. All terrestrial animals, even carnivores, rely on their health-giving or medicinal properties, directly or indirectly. Even around 30% of modern drugs owe their origin in some way to natural products, and of that, 10-20% are based on plant‑derived compounds, depending on definitions and counting methods.
EU HARMonisation of botanicals
For over two decades, the European Union (EU) has struggled to develop a coherent, proportionate framework for the regulation of health-promoting and therapeutic botanicals. That’s not to say that European institutions haven’t been trying to regulate botanicals—in fact, quite the opposite.
There have actually been 7 (yes, seven!) main ways in which the EU has tried to regulate botanicals since the start of the new millennium, each bringing with it its own range of problems for those seeking to benefit from the power of plants.
Nearly a quarter of a century on, the pitched battle between those Member States and institutions pushing for stringent regulation of health-promoting botanicals, versus those advocating for more liberal, rational and proportionate approaches (that’s us at ANH) continues—and is now entering a critical phase.
Before we delve into more detail on the latest herbal battlefront, it’s critical to understand something about the six regulatory mechanisms the EU and national regulators have used to-date. These all continue to work alongside the seventh—and likely most deadly—regulatory weapon that is currently in play. This particular mechanism has the potential to devastate the ability of Europe’s half a billion consumers to access health promoting and therapeutic botanicals.
Regulatory Mechanism 1: The Food Supplements Directive (2002)
When the framework Food Supplements Directive was passed into law in 2002, it was envisaged that future implementing provisions would harmonise laws on botanicals in food supplements, along with amino acids and fatty acids. This was delayed because of the difficulty of achieving consensus among different EU states. Germany, for example, has long pushed for a highly restrictive regime, while countries like Italy, have long advocated for one that is far more liberal, aligning with its own culture and attitudes towards herbals. In December 2008, the European Commission determined it was just too difficult and not necessary to progress with developing harmonised procedures for categories other than vitamins, something Recital 8 of the framework directive had planned to implement at a later date, as seen in the original Act), stating: “Laying down specific rules applicable to substances other than vitamins and minerals for use in food supplements is not justified. Moreover, the Commission doubts the feasibility of such a measure, which, in any case, is not necessary in the short term…”. Remember those words when we get to Regulatory Mechanism 7.
Regulatory Mechanism 2: The Human Medicinal Products Directive (2004)
By broadening the functional limb of the definition of a medicinal product (drug) through amendment of the base 2001 EU medicines law to include “any substance or combination of substances….administered to human beings to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action”, EU national regulators were given a loaded gun to call any botanical that had significant immunological or metabolic effects on the body (i.e., all botanicals) a drug. Their only safeguard from a drug regime is the weak exclusion provided in the preamble (Recitals) of the Directive, which exempts substances that are “clearly” foods, food supplements, cosmetics or medical devices. Among examples of botanicals targeted by this loaded gun in the hands of different EU regulators have been black cohosh (used to reduce menopausal symptoms), higher monacolin containing red yeast rice (to lower cholesterol naturally) and berberine (for immune support and as an anti-inflammatory).
Regulatory Mechanism 3: The Novel Food Regulations (1997 and 2015)
The original Novel Food Regulation (No 258/97) was established to ensure pre-market safety testing of the growing number of foods and food ingredients produced with new processes (e.g. novel extraction methods, new ingredients, early GM techniques) as well as non-traditional foods used widely outside the EU. The implementation date (15 May 1997) soon became the key date that acted a barrier for botanicals for which it wasn’t possible to prove significant history of use. Given complaints of discrimination against other cultures and increasing awareness of the limited value EU Novel Catalogue based on opinions from a working group comprised of representatives from the EU’s national governments, the Regulation was updated in 2015 (no. 2015/2283) to include a simplified system for botanicals from third countries for which evidence of 25 years safe use could be provided. It’s less of a barrier than it was but still acts as a significant obstacle to the sale of many botanicals from non-European traditions given the extensive data requirements.
Regulatory Mechanism 4: Traditional Herbal Medicinal Products Directive (2004)
One of the biggest herbal crises in human history, one that occurred in Brussels close to the seat of the European Commission and European Parliament, precipitated the Traditional Herbal Medicinal Products Directive (2004/24/EC) which was passed into law in 2004. In 1990–91, a Brussels weight‑loss clinic prescribed slimming regimens that combined conventional drugs with Chinese herbal formulas in which Stephania tetrandra was mistakenly substituted with Aristolochia fangchi. This mis‑substitution exposed thousands of mainly young women to high cumulative doses of aristolochic acid and ochratoxins, leading to an outbreak of rapidly progressive, irreversible kidney failure now known as Chinese herb nephropathy/Aristolochic acid nephropathy. Over 100 patients progressed to end‑stage renal disease and later developing urothelial cancers. After years of work in the European Parliament, the THMPD eventually saw light of day. As we predicted at the time, it wasn’t adapted in any way to traditional medicines of non-European origin—the very kinds of herbs it was originally intended to offer a safe harbour assuming they were safe—so it’s mainly become a simplified drug licensing system for medicines out of the much more recent, 20th century, European phytopharmaceutical “tradition”. The law demands that at least 15 years of safe use of the herbal product can be demonstrated in the EU. It has resulted in around 100 monographs being created, and while over 1000 products have been registered EU-wide, the vast majority relate to just 21 species of plant, and only 7 TCM herbs or products have been registered thus far, a drop in the ocean compared to the scale of the TCM Materia Medica. This references 5,321 medicinal plants, 826 medicinal fungi, and 153 medicinal minerals. One Tibetan medicine has been registered, but none have been registered from other traditions including Ayurveda, Kampo, Korean, Mongolian, Thai, Tibetan, Unani, Vietnamese, and traditional African medicine (TAM). The instigation of the THMPD has also created more uncertainty for botanicals being sold as food supplements that have a history of medicinal use, because national regulators are now more likely to argue that the appropriate regulatory pathway for the botanical is the THMPD, even if it’s effectively inaccessible (e.g., for technical reasons, excessive cost, or because it falls outside the scope of the traditional herbal medicinal product definition).
Regulatory Mechanism 5: The Nutrition and Health Claims Regulation (2006)
Back in 2006, the EU adopted Regulation (EC) No 1924/2006 to harmonise nutrition and health claims on foods, requiring that any health claim be scientifically substantiated and authorised at EU level after EFSA review. In an attempt to maintain claims that were already in use, food business operators submitted in 2008 some 44,000 “general function” health claims under Article 13.1, including several thousand for botanicals, which EFSA began to evaluate. However, given a lack of adequate guidance, many botanical dossiers relied on traditional‑use, animal studies and mechanistic evidence, at which point EFSA decided to reject all claims that were not supported by human intervention trials. The end result was that EFSA then issued negative or “insufficient evidence” opinions for the vast majority of these dossiers. We referred to it at the time as the Great Health Claims Cull, because of the 44,000 initially applied for, only 234 were approved. Fourteen years on, the number of health claims approved in the EU has only risen to 262 (see EU Health Claims Register). This led the European Commission in 2010 to suspend further evaluation of botanical claims and, in 2012, to create an “on‑hold” list of such claims. Under Article 28 transitional provisions, these on‑hold botanical claims can still be used pending a final decision, and in practice Member States have applied their national rules and enforcement priorities to decide which botanical claims may appear on food supplements, producing a patchwork of national approaches—some Member States being very intolerant of any botanical claims—rather than the fully harmonised, science-based system originally envisaged that would allow consumers across the EU to make informed choices about health-promoting plant foods and botanical ingredients.
Regulatory Mechanism 6: EFSA Botanical Compendium (launched 2009)
Following the request of the European Commission, EFSA was asked to create a Compendium of Botanicals (initially published by EFSA in 2009, updated in 2012, and current version here), effectively a reference list of botanical species that have been reported as ingredients in foods or food supplements marketed in the EU, compiled from multiple national and international sources to support risk assessment and regulatory decision‑making. Its primary purpose is not to “approve” plants, but to provide a structured overview of which botanicals are in use, their known constituents, traditional uses, and any identified safety concerns, so that EFSA and national authorities can more efficiently prioritise and conduct safety evaluations. The Compendium helps risk assessors and managers in Member States identify plants containing potentially hazardous substances (for example pyrrolizidine alkaloids or aristolochic acids), spot taxonomic ambiguities and misidentifications, and understand how particular botanicals are used in different Member States. It thus functions as a scientific and regulatory tool to improve the consistency and quality of botanical risk assessments across the EU, without itself having direct legal status or replacing product‑specific evaluations. Given that a large number of botanicals have potential toxicities at high doses, yet often offer quite distinct benefits along with no toxicity at lower doses (a process referred to as botanical or nutritional hormesis), the Compendium has unfortunately given national regulators a tool—one that is misused through lack of adequate knowledge—to use the precautionary principle to disallow specific botanicals in food supplements. To do this, they simply ignore evidence that the same botanical when used as intended, presents no safety concerns, only benefits.
Regulatory Mechanism 7: Food Fortification Regulation (2006)
Now we arrive at the regulatory mechanism that’s being brought to bear to deliver the most recent blow to the availability of plant compounds used for health purposes in the EU, outside a full drugs regime. In name, it might appear the least vicious of the lot, but it is the proverbial wolf in sheep’s clothing.
The Food Fortification Regulation (No 1925/2006), enacted in 2007, sought to regulate nutrients added to foods (which includes food supplements), “including, but not limited to, vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts” for nutritional and technological purposes. It’s the regulation that controls how food businesses determine how to fortify bread with folic acid and how to make a B vitamin-loaded energy drink. It’s also a framework regulation, so that idea was to kick off, like the Food Supplements Directive, only with vitamins and minerals, determining which vitamins or minerals, which forms, and maximum and minimum permissible amounts could be used (Annex II), as well as prohibiting others (Annex III).
But what about substances other than vitamins and minerals? Well, behind closed doors in Brussels, EU institutions and national food safety authorities have been steadily advancing measures that that may lead to the restriction or total prohibition of a range of botanical substances. These substances are widely used, well understood by consumers, and embedded in traditional dietary and health practices across Europe and beyond.
It’s now time to dive deeper into what’s happening with the Food Fortification Regulation, and attempts by regulators to enact sweeping botanical bans across the EU, undoubtedly with pressure from vested interests (Big Pharma did I hear you say?) opposed to the use of therapeutic botanicals.
From modest beginnings…
The Food Fortification Regulation (1925/2006) was never meant to become a botanical prohibition tool. Its original purpose was far more modest and sensible: to create a framework for the addition of vitamins and minerals to foods, and to give the EU a way of setting common rules where necessary, while still leaving room for foods and supplements to function in the real world. In other words, it was designed to manage added nutrients, not to become a backdoor mechanism for restricting widely used plant ingredients with a long history of dietary and health-related use.
Article 8 – the most dangerous mechanism for freedom of choice, was designed as a proportionate risk-management tool — a mechanism for dealing with specific safety concerns linked to real-world exposure. It wasn’t designed to become a de facto negative-list system for botanicals, nor a backdoor route to harmonise restrictions on plant substances that the EU had previously failed, or declined, to harmonise through more direct legislative means. The farther regulators move from actual intake, context of use and demonstrated risk, the farther they move from what the Regulation was meant to do.
How Germany led the anti-botanical charge
The current anti-botanical push didn’t arise out of the blue. In June 2024, the Heads of Food Safety Agencies Working Group on Food Supplements (HoA WG FS) adopted its first report. Its stated aim was to identify substances in foods and food supplements that may lead to adverse health effects and to consider whether Article 8 of Regulation 1925/2006 — and inclusion in Annex III — would be an appropriate regulatory route. The exercise began with a pool of 117 substances drawn from the DACH list and other sources, and the report itself states that Table 3 identifies 13 substances with the highest priority for a possible Article 8 procedure.
Formally, this was a European working group. In practical and political terms, however, Germany appears to have been at the centre of the initiative. The report was hosted through Germany’s Federal Office of Consumer Protection and Food Safety (BVL), and public coverage of the exercise identified the German Federal Institute for Risk Assessment (BfR) as the body communicating the report and its implications. By October 2024, the issue had become sufficiently contentious that a parliamentary question was tabled in the European Parliament asking why the Commission was opening new Article 8 procedures while four General Court cases were still pending, and explicitly referring to the HoA recommendation to evaluate 117 botanicals, with 13 as priorities; see the Trial of Thirteen below.
What is deeply troubling here is not merely that a list was drawn up, but the mindset behind it. As well as the fact there are another 100 botanicals waiting in the wings, their fate is predicated on the precedents set with these initial 13.
Once a hazard-led screening exercise is used to funnel widely used botanicals into Article 8 territory, the regulatory centre of gravity shifts from proportionate risk management to pre-emptive restriction. The legal form remains food law. The practical effect starts to look much more like a pharmacological exclusion regime based on toxicological principles original developed for pollutants that ignore human physiological interactions with nutrients and botanicals, such as hormesis.
Intervention by the European Court
That momentum—fortunately—then ran into a major legal obstacle. On 13 November 2024, the General Court of the European Union handed down judgments in four linked cases challenging the Commission’s 2021 hydroxyanthracene-derivatives measure: Aloe Vera of Europe v Commission (T-189/21), Ortis v Commission (T-271/21), Synadiet and Others v Commission (T-274/21), and Aboca and Others v Commission (T-302/21). In those rulings, the Court annulled key parts of the Regulation and, in doing so, imposed an important legal brake on the Commission’s use of Article 8 against botanicals.
The Court’s clarification centred around two main interpretations. First, it made clear that Article 8 is directed to “substances” and to “ingredients containing a substance”, not to broad botanical “preparations” as an all-purpose category. Second, it held that Article 8(2)(a)(i) presupposes a threshold-based showing: regulators must demonstrate not only a harmful effect on health, but also that use would result in ingestion of amounts greatly exceeding those reasonably expected under normal conditions of a balanced and varied diet.
This meant the Commission could not simply prohibit hydroxyanthracene derivatives and preparations irrespective of amount because EFSA had been unable to define a safe daily intake. In other words, absence of a threshold did not entitle the Commission to impose a blanket ban.
This matters far beyond the botanicals that were the original subjects of the 4 cases, namely aloe, rhubarb and senna. The judgments reassert that Article 8 is a narrow safety mechanism, not a blank cheque that allows EU institutions and national regulators to construct an EU-wide blacklist of botanicals on the basis of isolated hazards or scientific uncertainty alone. The case of kava (Piper methysticum) in which Germany and other EU countries imposed a ban without adequate evidence, and then was forced to repeal it in 2014, should have provided some lessons.
But the European Commission hasn’t just rolled over. It’s since appealed at least some of those November 2024 judgments, so the legal battle far from over. But the General Court has already delivered an unmistakable message: precaution cannot lawfully be severed from dose, exposure and legal threshold.
The Trial of Thirteen – ashwagandha,
This brings us to what might I refer to as the Trial of Thirteen. The HoA working group’s screening exercise started with 117 substances, but 13 were singled out as the most eligible for an Article 8 procedure.
These are listed in Table 3 of the HoA report (p. 21 of 56), and the following table summarises the concerns expressed by the HoA WG FS.
Table 1. The 13 Botanicals ‘on trial’
Substance / Preparation | Common Name / Other Comment |
|---|---|
Coumarin in plant preparations | Coumarin (naturally occurring in many plants like tonka beans, cinnamon; concern over liver toxicity at high doses) |
Curcumin in Curcumaspp.-preparations | Curcumin / Turmeric (Curcuma longa); flagged for potential CMR properties (carcinogenic, mutagenic, reprotoxic) |
Hypericum perforatum | St. John’s Wort; known for drug interactions (e.g., CYP3A4 induction) and photosensitivity |
Melaleuca spp.-essential oils | Tea Tree oil; concern over toxicity, especially ingestion or high exposure |
Melatonin* | Melatonin (hormone used in supplements for sleep); *often noted with asterisk in reports for specific considerations like dosing |
Piperine | Piperine (from black pepper); bioavailability enhancer, flagged for potential risks at supplement levels |
p-Synephrine in Citrus spp.-preparations | p-Synephrine / Bitter orange (Citrus aurantium); stimulant similar to ephedrine, cardiovascular concerns |
Tryptophan | L-Tryptophan (amino acid); history of EMS outbreak in 1989, now concerns over high-dose purity/safety |
Actaea racemosa | Black Cohosh; used for menopausal symptoms, liver toxicity concerns in some cases |
Lepidium meyenii | Maca / Peruvian ginseng; adaptogen, flagged for possible CMR properties |
Ocimum tenuiflorum | Holy Basil / Tulsi; adaptogen, potential CMR concerns noted |
Tribulus terrestris** | Tribulus / Puncture vine; used for testosterone support, **often with note on limited evidence or risks |
Withania somnifera*** | Ashwagandha; adaptogen for stress, ***concerns include potential liver effects, abortifacient history in reports |
Table 2. Scientifically established health/medicinal benefits or traditional uses of the 13 prioritised botanical substances (HoA List)
Substance / Preparation | Scientifically Established Benefits or Traditional Uses |
|---|---|
Coumarin in plant preparations | Traditional uses in herbal medicine for anti-inflammatory and antimicrobial effects; modern research shows antioxidant, anti-inflammatory, and potential anticoagulant properties in coumarin derivatives |
Curcumin in Curcuma spp.-preparations | Strong anti-inflammatory and antioxidant effects; traditional Ayurvedic use for digestive issues, wounds, and inflammation; supported for managing arthritis, metabolic syndrome, and oxidative stress |
Hypericum perforatum | Established for mild to moderate depression (acts on serotonin); traditional use for anxiety, wounds, burns, and nerve pain; also explored for menopausal symptoms |
Melaleuca spp.-essential oils | Antimicrobial, antifungal, and antiseptic properties; traditional Aboriginal Australian use for skin infections, cuts, and coughs; supported for acne, athlete’s foot, and minor wounds |
Melatonin* | Regulates sleep-wake cycles; established for jet lag, delayed sleep phase disorder, and some insomnia; traditional/modern use for improving sleep quality and reducing pre-surgery anxiety |
Piperine | Enhances nutrient absorption (e.g., curcumin); traditional Ayurvedic use for digestion; research shows antioxidant, anti-inflammatory, and potential digestive enzyme stimulation |
p-Synephrine in Citrus spp.-preparations | Traditional Chinese medicine for indigestion and weight management; limited evidence for mild weight loss/athletic performance support via metabolic effects |
Tryptophan | Precursor to serotonin and melatonin; supports mood, sleep, and emotional well-being; traditional/modern use for depression, anxiety, and insomnia (via serotonin pathway) |
Actaea racemosa | Established for reducing menopausal symptoms (e.g., hot flashes, night sweats); traditional Native American use for menstrual irregularities, musculoskeletal pain, and labor support |
Lepidium meyenii | Adaptogen for energy, fertility, and libido; traditional Andean use for reproductive health and stamina; supported for improving sexual function, menopause symptoms, and reducing fatigue |
Ocimum tenuiflorum | Adaptogen for stress reduction and metabolic health; traditional Ayurvedic use as ‘elixir of life’ for anxiety, immunity, and inflammation; supported for lowering blood sugar, cholesterol, and stress |
Tribulus terrestris** | Traditional use in Ayurveda and TCM for libido, fertility, and urinary issues; limited evidence for sexual function and athletic performance; explored for anti-inflammatory and cardioprotective effects |
Withania somnifera*** | Powerful adaptogen; traditional Ayurvedic use for stress, vitality, and longevity; well-supported for reducing anxiety, cortisol, improving sleep, cognitive function, and athletic performance |
The implications for all of this are profound. They are not theoretical or imaginary. We are already fighting the ban on ashwagandha in the EU—one being pushed by the Dutch government—once one of the most liberal in the EU, now increasingly restrictive. A change in direction perhaps precipitated by the shift of the European Medicines Agency from London to Amsterdam following Brexit.
Many of these 13 substances on trial are deeply embedded in traditional dietary and self-care practices, widely recognised by consumers, and used in forms and amounts that have long histories of safe use. Yet once they are pulled into an Article 8 pipeline through a hazard-first screening exercise, the debate changes. The question ceases to be whether there is evidence of harm under normal conditions of use, and becomes whether businesses can somehow disprove a regulatory presumption generated by theoretical concern, isolated constituents or worst-case toxicology. That is precisely the drift from risk management to risk elimination — and it is exactly the drift the EU General Court warned against.
Just to emphasise that the European Commission means business in its anti-botanical mission: EFSA states that the Commission has already asked it to conduct safety assessments on berberine-containing plant preparations, bitter and sweet fennel, and hydroxycitric acid, and EFSA working-group minutes from 2025 (here and here) refer to twelve new Article 8 mandates in the pipeline. So the “thirteen” are best understood not as an isolated list, but as the front edge of a broader regulatory strategy. Unless Article 8 is brought back within its lawful limits — grounded in real-world exposure, proportionality and sound risk–benefit reasoning — it risks becoming the most powerful anti-botanical instrument the EU has yet deployed.
Conclusion: Europe must choose scientific maturity over botanical erasure
Taken together, these seven regulatory mechanisms reveal a pattern that cannot be ignored by any European citizen who values their health and wishes to manage it by natural means. What began as a series of measures ostensibly designed to improve safety, harmonise trade, and inform consumers has progressively evolved into something far more corrosive: a regulatory environment in which health-promoting botanicals can be marginalised, reclassified, restricted, or banned through multiple overlapping routes.
Article 8 of the Food Fortification Regulation is the latest and potentially most dangerous expression of this trend, because it offers a route to EU-wide restrictions on substances used in foods and food supplements without requiring the kind of proportionate, context-sensitive framework that botanicals demand.
At the heart of the problem is a scientific mismatch. Classic toxicological models work reasonably well for some contaminants and single chemicals, but they are often a poor fit for botanicals and phytochemicals that act through biphasic dose responses — low-dose adaptive or beneficial effects, and high-dose adverse effects.
This is the essence of hormesis that is a fact of life and central to human/nutrient/phytochemical interactions. The literature on phytochemicals describes exactly these kinds of adaptive responses, including activation of cytoprotective pathways such as Nrf2/ARE (e.g., here and here); more recent reviews likewise note that several phytochemicals and polyphenols can act as mild stressors that induce protective responses at lower doses, while becoming harmful at higher ones.
A regulatory system that looks only for hazard at one end of the dose range, while ignoring benefit, exposure, matrix, and biological adaptation, is using the wrong lens for the material in front of it. It’s why we’ve done so much work (see here and here) helping to develop risk-benefit models for vitamins and minerals to aid the establishment of maximum permitted levels that are not overly restrictive. In the full knowledge that the time for botanicals would come. It is now that time.
That is why the future of botanicals in Europe cannot be left to hazard screens, closed working groups, or precaution detached from real-world use. If regulators are serious about protecting public health, they must assess botanicals as they are actually consumed: in preparations, at plausible doses, over realistic durations, and in the context of historical and traditional use. EFSA itself already recognises, in other food contexts, that risk–benefit assessment should include both hazardous and beneficial components, dose–response modelling, and the integration of risk and benefit rather than the isolation of one from the other. There is no good scientific reason why botanicals should be denied that same maturity of assessment.
What we can do to save botanicals in the EU
The practical ask is therefore clear. Citizens, practitioners, producers, importers, and responsible retailers should insist that no botanical be restricted under Article 8 unless regulators can show actual harm at real-world levels of intake, using substance-specific evidence, proper exposure assessment, and transparent reasoning. They should also insist that traditional use — including use from non-European systems such as Ayurveda, TCM, Kampo, Unani, Tibetan, African and other traditions — be treated as relevant evidence, not brushed aside simply because it does not fit a pharmaceutical template. The question should not be whether a plant can cause harm under some artificial condition. The question should be whether, as used in food or supplements, it presents a net risk or a net benefit to the population. If it is found to present a risk to some, and a benefit to others, what is the best way of managing that risk—such as through label warnings—so that others can experience benefits. This is exactly how we manage allergens such as gluten, dairy and nuts, excessive doses of sugar alcohols like xylitol, and even heavy metals in oily fish.
There are also concrete civic and regulatory levers available now. The European Commission’s Have Your Say portal is expressly designed for citizens and stakeholders to give views on EU initiatives and laws. The European Parliament’s petitions process is open not only to EU citizens and residents, but also to companies, organisations, and associations headquartered in the EU. And where a broader legislative response becomes necessary, the European Citizens’ Initiative (we are currently engaged in building a 7+ country group of representatives for this specific purpose) provides a route for EU citizens to push the Commission to consider legislation, provided at least one million valid signatures are collected across at least seven Member States. Alongside these formal channels built into the EU system itself, we need to use every element of grassroots momentum we can generate.
The immediate task for companies and civil society is not merely to complain, but to organise. Companies should compile high-quality dossiers on identity, composition, preparation, intake, traditional use, post-market experience, and adverse-event context. Trade bodies and practitioners should coordinate shared evidence banks and rapid-response coalitions whenever Article 8 or related safety reviews are launched. Citizens should support organisations defending proportionate regulation, submit evidence and comments when consultations open, and use petition mechanisms to challenge regulatory overreach. For producers and traditions outside Europe, the strategic route is to work with EU-based partners, importers, practitioners, and associations so that these voices are formally represented inside the decision-making process.
If this does not happen, Europe risks sleepwalking into a system in which many of the world’s safest and most widely used health-promoting botanicals are slowly pushed out of foods and supplements and into either legal limbo or full pharmaceutical capture. That would not be a triumph of science. It would be a failure of scientific judgement, regulatory proportionality, and cultural respect that works directly against the health of the European people. Europe should not become a place where centuries of accumulated, multi-cultural human experience with botanicals are discarded in favour of a one-dimensional model that mistakes biological complexity for danger. It should become a place where safety is assessed rigorously, yes — but also intelligently, proportionately, and in a way that preserves citizens’ lawful access to the plants and traditions that have helped sustain human health across cultures for centuries.
What must happen now
- No Article 8 restrictions without proof of real-world risk at actual intake levels.
- Botanicals must be assessed using risk–benefit principles, not hazard alone.
- Traditional use and post-market experience must count as evidence, including avoiding any discrimination against non-European traditions.
- Citizens and EU-based companies should use formal EU channels — consultations, petitions, and where appropriate a citizens’ initiative — to oppose disproportionate restrictions.
- The food supplement, herbals and botanicals industry, coupled with leading herbal practitioners must organise now: pool safety data, document normal use patterns, and challenge any attempt to turn Article 8 into a backdoor botanical blacklist.
- Industry and citizens must recognise that legal challenge may be required to curb the excesses of the anti-nature corporatocracy that remains—at least for the time being—the puppet master of the unelected European Commission.
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2 Responses
This is alarming news and needs to be challenged most vigorously , keep up the good work.
I suspect the Zionist Cabal and their useful idiots consider juicy or disgusting cricket dinners to be sufficient to replace those harmful, natural, safe and effective herbs. Consumers or idiots that eat this inedible insecticidal poison will be safely and effectively offered or forced any one of an `approved` lethal vex ine so there is nothing to worry about.
Please keep me informed