By the PharmaTradz BD Team. Published October 2026.
Ashwagandha is one of the best-selling botanicals of the decade. It appears in stress, sleep and women's health formulas, in gummies and powders, and as an ingredient in functional drinks. Its regulatory position in Europe is now shifting. The Netherlands has notified the EU of draft rules that would ban ashwagandha leaf, ban huperzine A, cap black cohosh, and add warning statements for a long list of familiar herbs. The rules are not final yet. But if you make, export or private-label supplements for the European market, this is the moment to check your portfolio, before a deadline does it for you.
What the Dutch draft proposes
The Dutch Ministry of Health first floated these changes in early 2025. It has now formally notified the draft to the EU. That opens a review period, running until 7 December 2026, in which the European Commission and other member states can comment. Based on the draft as reported:
| Ingredient | Proposed rule |
|---|---|
| Ashwagandha (Withania somnifera) leaf and leaf preparations | Banned |
| Ashwagandha root | Still allowed, with a caution statement on the label |
| Huperzia serrata and huperzine A | Banned |
| Black cohosh (Cimicifuga racemosa) | Maximum of 40 mg per day |
| Garlic, green tea, turmeric, ginkgo, St John's wort, Mucuna pruriens, American ginseng, red sage, milk thistle, valerian, black cohosh | Mandatory warning statements |
If the rules are adopted, they could take effect as early as late 2026, with a six-month transition period for products already on the market.
Some coverage has described the proposal as a full ashwagandha ban. The detailed reporting describes a ban on leaf material, with root still allowed under a warning. The difference matters a great deal for formulators, so read the notified text itself rather than rely on headlines.
Why ashwagandha keeps coming up
The Netherlands is not acting alone. Ashwagandha has been on European regulators' agenda for several years.
- Denmark banned ashwagandha in food supplements in 2023, citing possible hormonal effects and risks in pregnancy.
- Germany has completed a national safety assessment. It has issued recommendations and warnings but no legal ban.
- Sweden, France and Poland require warning statements, and Poland also sets maximum daily amounts.
- In 2024, the heads of national food safety agencies named ashwagandha a high priority for action. EFSA is expected to assess its safety, although no timetable has been set.
- India has also moved. In April 2026 its Ministry of Ayush directed manufacturers and exporters of Ayush products to use only ashwagandha root, in crude or extract form, and to stop using the leaf.
The concerns raised across these reviews include rare reports of liver injury, possible effects on thyroid and hormone levels, and use in pregnancy. Industry groups argue that well-characterised root extracts have a good safety record in clinical studies. That debate will continue. The direction of travel, though, is clearly towards root-only, well-specified extracts with clear labelling.
Does mutual recognition protect you?
In part. Under the EU's mutual recognition principle, a supplement lawfully sold in one member state can generally be sold in the others. A product legal in Belgium or Germany could, in principle, still enter the Dutch market.
The principle is not absolute, however. A member state can restrict a product to protect public health, as long as the measure is proportionate. A national ban backed by a safety assessment is exactly the kind of measure that can override mutual recognition. Plan on the basis that a product banned in the Netherlands will not be sold there, whatever its status elsewhere.
What exporters and brand owners should do now
| Step | What it involves |
|---|---|
| Map your exposure | List every SKU sold in or through the Netherlands that contains ashwagandha, huperzine, black cohosh or one of the warning-list herbs |
| Confirm the plant part | Get written confirmation from your extract supplier that the material is root only, with a test method able to detect leaf |
| Check doses | Work out the daily intake of black cohosh in each product against the proposed 40 mg cap |
| Prepare label changes | Draft the warning statements now, so new packaging can be ordered as soon as the final wording is published |
| Plan reformulation | For products that rely on huperzine A or leaf extract, identify substitute ingredients and allow time for stability work |
| Comment if it affects you | Companies and trade associations can send comments through the EU notification system before 7 December |
There is also a supply chain angle. Buyers are already asking for root-only certificates, identification testing that can tell root from leaf, and full traceability back to harvest. Suppliers that can provide those documents with their first quote will find Europe an easier market than those that cannot.
How we can help
We work with GMP and food-safety certified contract manufacturers for capsules, tablets, gummies, softgels and powders, and with botanical extract suppliers who can document plant part, identity and contaminant testing. If you need to reformulate for Europe, or want a second source for a root-only extract, send us your specification. You can also read our guide to private-label nutraceutical manufacturing or browse our nutraceutical services. For the wider market, see our Netherlands market guide. When you are ready, send a request for a quote.
Sources: Dutch draft supplement and herbal preparation rules as notified to the EU (review period to 7 December 2026), reported by NutraIngredients (6 and 12 October 2026); Danish ashwagandha ban (2023); Government of India Ministry of Ayush directive on ashwagandha root (April 2026); trade press summaries of member state positions. This is a draft proposal and may change; it is not regulatory advice.
Frequently Asked Questions(FAQs)
Is ashwagandha banned in the Netherlands?
Not yet. The Netherlands has notified the EU of draft rules, and the review period runs to 7 December 2026. As reported, the draft bans ashwagandha leaf and leaf preparations but still allows root with a caution statement. The final text may change.
When could the Dutch rules take effect?
If they are adopted, possibly as early as late 2026, followed by a six-month transition period for products already on the market.
What happens to black cohosh under the proposal?
It would be limited to 40 mg per day and would also need a warning statement on the label.
Which other countries restrict ashwagandha?
Denmark banned it in food supplements in 2023. Sweden, France and Poland require warning statements, and Poland also sets maximum daily amounts. Germany has issued recommendations, and India has restricted Ayush products to root material only.
Can a product legal elsewhere in the EU still be sold in the Netherlands?
Mutual recognition generally allows it, but a member state can restrict a product to protect health if the measure is proportionate. A national ban backed by a safety assessment can override mutual recognition.
