Why European Regulators Are Scrutinising Ashwagandha — and What Supplement Brands Must Test Before Going to Market

The ANSES bulletin arrived quietly — as most food safety documents do — but its implications for brands selling ashwagandha across the EU were anything but quiet. France’s national food safety authority had reviewed 27 spontaneous reports of adverse effects linked to ashwagandha supplements, including cases of hepatotoxicity, thyroid dysfunction, and dermatological reactions. That was enough to trigger a formal vigilance call and a recommendation against use in vulnerable populations, including people with thyroid disorders, pregnant women, and those on immunosuppressive therapy.

Denmark didn’t wait for European consensus. The Danish Veterinary and Food Administration (Fødevarestyrelsen) moved to restrict the marketing of high-dose ashwagandha products, pointing specifically to the root extract’s thyroid-stimulating properties and the potential for endocrine interference at doses commonly found on the retail shelf.

The global ashwagandha market is projected to exceed €1.2 billion by 2027, driven heavily by European wellness brands capitalising on adaptogen demand. But regulatory scrutiny is accelerating alongside that growth — and brands that haven’t looked hard at their testing protocols are carrying risk they probably can’t see yet.

What’s Actually Driving the Regulatory Concern

The problem with ashwagandha isn’t that Withania somnifera is inherently dangerous. Traditional Ayurvedic use of the root spans thousands of years, at doses and preparation methods quite different from modern concentrated extracts. What ANSES and other regulators are reacting to is the gap between that traditional context and what’s actually on European shelves today.

Highly standardised extracts — typically marketed at 5% to 10% withanolides — deliver amounts of bioactive compounds that have no real historical precedent in the European food supplement context. Withanolides are the steroidal lactones responsible for most of ashwagandha’s pharmacological activity. They influence cortisol regulation, thyroid hormone pathways, and potentially immune signalling. At 600 mg/day of a 5% withanolide extract, you’re delivering approximately 30 mg of these compounds to the consumer. At 10% standardisation, that doubles.

The clinical literature supporting stress reduction and cognition benefits at these doses exists — and it’s growing. But so do the adverse case reports, particularly in people with thyroid conditions or those taking thyroid medication. EFSA has not established any authorised health claim for ashwagandha under Regulation (EC) No 1924/2006, which means every claim appearing on a European product label is navigating a legal tightrope. And regulators watching adverse event databases are quietly starting to connect the dots.

The Testing Gap That’s Quietly Causing Problems

When we review ashwagandha products from European supplement brands — and we see a fair number across our network — the most common failure isn’t heavy metals or pesticides. It’s withanolide inaccuracy.

Declared standardisation on finished products is remarkably inconsistent. Products claiming 5% withanolides may test anywhere from 2.8% to 7.4%, depending on the extraction method, the reference standard used, and how recently the batch was actually tested. A 2021 market survey on botanical supplements found that approximately 30% to 40% of products tested failed to meet their declared potency specifications within accepted variability margins. Ashwagandha extracts were among the most variable categories reviewed.

Part of the confusion is definitional. Is “5% withanolides” quantified against withaferin A alone as a primary marker, or calculated as total withanolides across the full profile? These are not the same thing. A supplier may report one; your analytical lab may measure the other. Without a specified and validated reference standard in your specification sheet, the two numbers are essentially not comparable — and neither provides a defensible basis for a label claim.

This creates two simultaneous compliance risks. First, the obvious one: a product with less withanolide content than declared is mislabelled. Second, and less obvious: a product with significantly more than declared could be placing specific consumer populations at risk. In France, where ANSES is actively monitoring the adverse event database, a cluster of hepatotoxicity cases traced to a high-withanolide batch could trigger a RAPEX rapid alert and a market withdrawal within days.

Botanical identity is a separate concern altogether. Withania somnifera isn’t the only species in the genus. Poorly sourced raw material can include Withania coagulans or other species with meaningfully different alkaloid profiles. DNA barcoding resolves this — it’s now the preferred method in most well-resourced analytical laboratories for definitive species confirmation — but it must be combined with HPLC fingerprinting to verify the full phytochemical profile of the extract. Macroscopic or microscopic examination alone is not sufficient for concentrated extracts, and it won’t hold up to regulatory scrutiny.

What an Adequate Testing Protocol Looks Like

For any brand pursuing ashwagandha testing in Europe, the analytical scope matters as much as the method. A defensible product file for an ashwagandha supplement sold across EU member states should include documentation covering at least five areas:

1. Botanical identity. DNA barcoding of the raw material, confirmed against an authenticated reference standard for Withania somnifera. Supplemented with HPLC fingerprinting showing a consistent withanolide profile across supply batches from the same source.

2. Withanolide quantification. HPLC analysis with a clearly specified reference standard — typically withaferin A as the primary quantitative marker, reported as total withanolides by calculation. The method should be validated per ICH Q2(R1) requirements. Acceptable batch-to-batch variability should fall within ±15% of the declared content; anything wider than that signals a raw material sourcing or manufacturing process problem.

3. Heavy metal screening. EU Regulation (EU) 2023/915 establishes maximum levels for lead, cadmium, mercury, and arsenic in food, including food supplements. Ashwagandha root grown predominantly in India and parts of Northern Africa can accumulate heavy metals due to soil contamination and agrochemical use. Maximum levels for lead in food supplements are set at ≤3.0 mg/kg; cadmium at ≤1.0 mg/kg. ICP-MS is the method of choice — it provides the sensitivity to detect contamination well below regulatory limits, giving your quality team time to act before a problem reaches consumers.

4. Pesticide residue screening. EU Regulation (EC) No 396/2005 and its successive amendments govern maximum residue limits for pesticides in food. Ashwagandha root from South Asian supply chains frequently shows residues of organophosphates and synthetic pyrethroids applied during cultivation. A comprehensive screening panel covering at minimum the 500+ compounds monitored under current EU MRL regulations is what a serious quality programme demands. Anything narrower leaves blind spots.

5. Microbial contamination. Total aerobic count, Enterobacteriaceae, yeast and mould, and specific pathogens including Salmonella spp. and E. coli O157:H7. Herbal root materials are especially prone to field-level microbial contamination; validated heat treatment or irradiation processes must be documented in your manufacturing records, and finished-product microbial testing confirms that process actually worked.

The Novel Foods Question: Not a Footnote

One aspect of EU ashwagandha compliance that consistently catches brands off-guard is Novel Foods status, and the uncertainty surrounding it.

Regulation (EU) 2015/2283 governs foods and food ingredients that were not consumed to a significant degree within the EU prior to 15 May 1997. Ashwagandha root in traditional herbal preparation form may have pre-existing use in some member states, potentially exempting it from Novel Foods authorisation in those jurisdictions. But ashwagandha root extract — particularly concentrated extracts standardised to withanolide content — is a different question, and member state competent authorities have taken divergent positions on it.

France’s DGCCRF enforcement has been inconsistent on this point, which is exactly the kind of ambiguity that creates real commercial risk. A product that has been sold without challenge in Germany for two years can still face a compliance query from Italian or French authorities if the Novel Foods status hasn’t been formally confirmed. And since the UK Food Standards Agency moved post-Brexit to classify ashwagandha extracts as requiring Novel Foods authorisation before commercial sale, brands with both EU and UK ambitions face a compounding problem.

The answer isn’t to assume. For each target market, you need a written position from the relevant competent authority, or a documented legal opinion grounded in that jurisdiction’s Novel Foods guidance. This is not a document most brands have. It should be.

Why Testing Infrastructure Matters as Much as the Protocol

The most common mistake we encounter isn’t a failure to understand what needs testing. It’s a failure to find a laboratory that can actually do all of it — in a single engagement, with validated methods, and with turnaround times that fit a commercial launch schedule.

Most European analytical laboratories are configured for pharmaceutical chemistry or general food testing. Neither maps cleanly onto botanical supplement requirements. Validated withanolide HPLC methods require authenticated reference standards and botanically specific matrix validation. DNA barcoding requires a well-maintained species reference library. Full pesticide panel screening on a complex herbal matrix requires multi-residue methodology validated for that matrix — not simply carried over from a standard food application.

Care Europe’s partner laboratory network was built to address exactly this gap. We connect European supplement brands to ISO 17025-accredited facilities with genuine botanical and herbal testing expertise — including specialist labs in the US and Canada where the infrastructure for botanical supplement testing is substantially more developed than in most EU markets. For ashwagandha specifically, that means withanolide quantification validated against AOAC-recognised reference standards, DNA barcoding with curated botanical reference databases, and pesticide panels calibrated for Indian-origin agricultural matrices.

Getting that testing completed before your product reaches the French or Scandinavian market isn’t a precaution anymore. Regulators in both countries have demonstrated they are watching.

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A practical starting point: pull your current finished-product testing report and confirm it includes withanolide quantification with a specified reference compound, botanical species confirmation by DNA barcoding, and a full ICP-MS metals panel. If any of those are missing, that’s the first conversation to have — with your contract manufacturer, and with your testing laboratory.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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Related from our network

• Botanical Identity & Herbal Supplement Testing at ISO 17025 Standards — Qalitex Laboratories offers validated withanolide HPLC quantification, DNA barcoding, ICP-MS metals screening, and full pesticide panels for botanical supplement brands entering the US market.
• Natural Health Product Compliance for Herbal Supplement Brands in Canada — Androxa supports European brands navigating Health Canada’s NHP licensing requirements, including safety assessments and ingredient documentation for botanical actives like ashwagandha.