Ashwagandha regulations differ by destination market. Some authorities restrict Withania somnifera root and root extracts. Others distinguish root from leaf, or set conditions on the recommended daily portion and the warning text. An ashwagandha supplement manufacturer quotation has to follow that destination file, not a single “root-only” claim.
Choosing a root extract does not, by itself, close market-access or safety questions. The applicable text depends on the country, the material actually used, the declared daily portion, and whether the instrument is in force, a notified draft, an advisory, or a risk assessment.
The comparison below restates published national positions and proposed changes, then sets out the plant-part, withanolide, and labeling fields buyers usually send before a manufacturing review.
National figures are not recommended intakes, and they are not a European Union maximum. A proposed rule is not an effective requirement. A plant-part restriction is not a finding that another plant part is safe.
What Is Changing in Ashwagandha Regulation?
Buyers often hear that authorities are banning the leaf and allowing the root. That sentence fits one set of files. It does not describe the whole file set.
Plant-Part Restrictions vs Root Safety Concerns
Two different decisions sit on the same botanical.
Plant-part identity. Some authorities now treat leaf, aerial parts, or unspecified biomass as a different material from root. The Dutch draft and the Indian Ayush and FSSAI texts of April 2026 sit here. [7][8][12][13]
Root itself. Other authorities assessed root or root extract and could not set a health-based guidance value. Denmark’s food-sale prohibition and the French and German population advice sit here. [3][5][6][11]
A root specification answers the first question. It does not answer the second.
National Limits, Warnings and Regulatory Status
Where root remains on the market, the warning text and the withanolide arithmetic are national. Poland’s Dietary Supplement Team opinion records a powdered-root daily amount and a separate withanolide amount for the recommended daily portion. [10][20] Australia’s safety advisory is written on the species, not on a plant-part split. [15]
There is no Union-wide ashwagandha maximum daily intake. Food supplements that contain botanicals are still checked against national plant lists. Regulation (EC) No 1925/2006 allows a substance to be placed under Community scrutiny when a possible harmful effect has been identified and scientific uncertainty remains. [2] BfR has recommended that path for the root. [3][4] That recommendation is not the same as an adopted Annex III listing.
The European Medicines Agency’s Committee on Herbal Medicinal Products did not adopt an EU herbal monograph for Withaniae somniferae radix. It found that the herbal preparation could not be specified to pharmaceutical requirements and that the 30-year traditional-use test, including 15 years in the Union, was not met. [1] That file is a herbal-medicine assessment. It is not a food-supplement authorisation, and it is not a food-supplement ban.
Ashwagandha Regulations by Country
The table is an overview for a first screen. It is not legal advice. Status terms are kept separate on purpose: a food-sale prohibition, a notified draft, a Team opinion used in supervision, a risk assessment, a safety advisory, and a direction subject to a petitioner-limited stay are different instruments.
Regulatory status in this draft was checked on 22 October 2026 against the official records cited below.
Market | Status | Plant part / key condition | Label or risk focus | Usual next step |
|---|---|---|---|---|
| Denmark | Food-sale prohibition, in force | Covers the plant, including root and root extracts | Not a standard food-supplement path | Do not place a food or food-supplement SKU |
| Netherlands | Notified draft; not in force | Draft would prohibit parts other than root; root would stay with a warning | Draft warning names pregnancy, breastfeeding, liver, and thyroid | Watch the final text and the commencement date |
| Poland | Dietary Supplement Team opinion used in sanitary-inspection practice | Powdered root below 3 g/day; total withanolides not more than 10 mg in the recommended daily portion — two separate figures | Sedative, hypnotic, or antiepileptic medicines; children, pregnancy, lactation | Check daily-portion arithmetic, analyte definition, method, and the quantitative specification |
| France | Risk assessment and population advice | Not a root-only authorisation | Named populations and selected medicines | Run a destination-specific label and population review |
| Germany | Risk assessment and population advice | No health-based guidance value derived | Children, pregnancy, lactation, existing liver disease | Do not treat a standardised root extract as a safety clearance |
| India | Ayush direction and FSSAI advisory; petitioner-limited interim stay | April 2026 texts state root only; stay applies only to the petitioners | Plant part must be readable on the file | Confirm whether the operator is covered by the stay, then read the current order |
| Australia | TGA safety advisory | Written on Withania somnifera; no root/leaf split | Gastrointestinal reactions; very rare liver injury | Review the complementary-medicine path and the current advisory |
Denmark and the Netherlands
Denmark. The Danish Veterinary and Food Administration states that products containing ashwagandha are unlawful to sell as food. The underlying DTU assessment of 15 May 2020 examined the root and extracts of the root. DTU concluded that, on the data then available, no intake could be identified below which use would be without risk of harmful effects. The published grounds include effects on sex hormones and reproduction, and possible effects on metabolism, the immune system, and the central nervous system. [5][6]
Netherlands. The Ministry of Health notified a draft amendment to the Herbal Preparations Decree and the Food Supplements Decree as TRIS 2026/0486/NL on 4 September 2026. The standstill ends on 7 December 2026. That date is the end of the comment period. It is not a commencement date, and it does not mean the draft will be adopted in that form. [8]
After the 2025 consultation, the Ministry left the leaf on the proposed prohibited list and moved the root to the proposed conditional list pending a new RIVM assessment. The consultation report records this draft warning: do not use in pregnancy, during breastfeeding, or if you have liver and/or thyroid problems; ashwagandha can, in very rare cases, cause liver problems. The Netherlands and Germany have asked the Commission to open a European safety assessment. [7][8][9]
RIVM’s 2024 assessment is the scientific file behind the draft. At the time of writing, the Netherlands had no specific Commodities Act restriction on Withania somnifera, and the Union had no ashwagandha-specific maximum. [9]
Poland, France and Germany
Poland. Resolution 7/2020 of the Chief Sanitary Inspectorate’s Dietary Supplement Team is a written opinion. GIS publishes the same figures on the Team page and uses them in supervision. The resolution is not a statute. In inspection practice it still shapes how a notification is read. [10][20]
The opinion records two separate conditions, not one interchangeable limit:
- Powdered Withania somnifera root below 3 g per day.
- Total withanolides not more than 10 mg in the recommended daily portion, with a quantitative specification for that portion.
The published warning concerns sedative, hypnotic, or antiepileptic medicines, and use in children, pregnancy, and lactation. [10][20]
What the 10 mg figure means for a formula
A label that prints 300 mg of extract at 5% withanolides, using the same analyte definition and the same method, gives:
300 mg × 5% = 15 mg withanolides per daily serving.
Resolution 7/2020 records 10 mg in the recommended daily portion. [10]
Those two numbers can be compared only when the percentage, the method, and the recommended daily portion use the same withanolide definition. A spectrophotometric total and an HPLC result are not interchangeable. Extract milligrams and the finished daily portion are also different calculation steps. The 10 mg figure is a Polish Team condition. It is not a general safety dose for other countries.
France. ANSES’s opinion of 19 April 2024 (saisine 2021-SA-0077) advises against use by people with thyroid, liver, or heart conditions, hyperandrogenism, pregnant women, and people taking sedative or central-nervous-system depressant medicines. Because data are lacking, it also advises against use by breastfeeding women and children. The opinion notes that whole-plant preparations have been accepted in Belgium and Italy without a matching French plant-list entry, and that daily withanolide and alkaloid amounts are rarely declared. [11] That is population advice. It is not a marketing authorisation.
Germany. BfR Communication 39/2024, dated 10 September 2024, updates the 2012 root assessment. BfR states that a health-based guidance value still cannot be derived. It advises that children, pregnant and breastfeeding women, and people with acute or pre-existing liver disease should not take ashwagandha supplements, and that other groups should use caution. It notes that European products now use root and, in some cases, leaf, and that composition varies with plant part and extraction method. [3][4]
India and Australia
India. On 15 April 2026 the Ministry of Ayush directed Ayush manufacturers to use only roots, in crude, extract, or other form, and stated that leaves are prohibited. The letter cites possible safety concerns for leaves because of higher reactive withanolides, particularly withaferin A. [12] On 16 April 2026 FSSAI stated that Schedule IV of the 2016 nutraceutical regulations permits only roots and their extracts in the named food categories. [13]
On 12 May 2026 the Karnataka High Court stayed those two instruments only for the petitioners in W.P. No. 14990/2026 and W.P. No. 15010/2026, until the next hearing. The court listed the matters for 8 June 2026. [14] The High Court case-status record available for this draft still shows the 12 May 2026 order as the last posted action, with the case pending. A later public order was not located when this draft was checked on 22 October 2026. The stay is not a nationwide revocation. Operators who are not petitioners remain under the published April texts unless a later order says otherwise.
Australia. TGA’s 22 February 2024 safety advisory reports gastrointestinal reactions and a very rare risk of liver injury associated with medicines and herbal supplements containing Withania somnifera. The alert does not separate leaf from root. TGA said it would consider label warnings or other changes if further evidence arises. [15]
Why Root and Leaf Are Not Interchangeable
Root and leaf are different purchase lines. Official assessments say that for chemistry and identity, not because a root extract has been cleared.
Chemical Fingerprints and Plant-Part Identity
WHO’s medicinal-plant monograph is written on Radix Withaniae, the dried root of Withania somnifera (L.) Dunal. The main constituent groups it names are withanolides and alkaloids. [16]
DTU compared published assays of root, leaf, fruit, and stem. Both organs contain withanolides and alkaloids, but the pattern is not the same. In the Indian sample sets DTU tabulated, withaferin A was often reported at higher levels in leaf than in root, while withanolide A was more characteristic of root. Total alkaloid figures also moved with organ and genotype. DTU still could not name which constituent, or which dose, accounts for the effects reported in animals and humans. [6]
BfR makes the manufacturing point in shorter form: European supplements now use root and, in some cases, leaf; extraction method changes the constituent profile; and the substances and dosages responsible for the reported effects cannot yet be named. [3]
Ayush’s 2026 direction treats the higher concentration of reactive withanolides, particularly withaferin A, as a reason to keep leaf out of Ayush products. [12] That is a plant-part decision. It is not a finding that withaferin A is the established cause of the liver-injury reports, and it is not a finding that root extracts have no hepatic or endocrine signal.
Withanolides, Analytical Methods and Adulteration
ANSES’s expert committee recorded that root products can be adulterated with leaf, which is richer in alkaloids, and that quality failures introducing other plants are already described. It also noted that a pharmacopoeial standardisation exists for root or root extract in the USP Dietary Supplements Compendium, and that a comparable standard is not in place for other plant parts. [11][17]
A total-withanolide percentage from a non-specific spectrophotometric method does not settle identity. Two lots can print the same percentage and still differ by plant part, by the definition of “withanolides” versus “withanolide glycosides,” and by the method. Those remain separate lines on the specification.
Why Root Extracts Still Raise Safety Questions
A leaf restriction does not close the root file. DTU, BfR, and RIVM each concluded that the available data do not support a health-based guidance value for root or root extract. [3][6][9] BfR lists the gaps: human studies were designed around possible benefits, adverse effects were not collected systematically, combination products confound causality, and long-term intake is poorly described. [3]
The signals below are reported associations and regulatory cautions. They are not a demonstration that one constituent is the sole cause.
Liver and Thyroid Safety Signals
NIH’s Office of Dietary Supplements summarises published liver-injury reports, including a five-case series from Iceland and the U.S. Drug-Induced Liver Injury Network, at labelled daily amounts of 450–1,350 mg ashwagandha. Plant part was not specified in every case, some products were combinations, and not every product was independently verified. Liver tests often improved after the product was stopped. [18] NCBI LiverTox describes a cholestatic or mixed pattern, usually after two to twelve weeks, that generally resolved. [19] TGA’s 2024 alert is written on Withania somnifera as an ingredient, not on leaf alone. [15]
Those reports are why the Dutch draft warning mentions rare liver problems, and why BfR and ANSES name existing liver disease among the groups advised not to use the products. [3][8][11]
DTU and BfR also treat thyroid-hormone changes, including a published thyrotoxicosis case after an ashwagandha supplement, as a reason they cannot set a safe food intake. [3][6] ANSES lists thyroid disease among the groups advised not to use the products. [11]
Reproductive Safety and Medicine Interactions
WHO’s root monograph records nausea, vomiting, and diarrhoea, and contraindicates use in pregnancy and lactation because safety data are lacking and because the root has a traditional abortifacient use. [16] BfR used the thyroid evidence and that traditional use when it recommended Community scrutiny of the root. [4] Food-supplement assessments in the Member States that have published files do not weigh a medicinal benefit against a residual risk. [7] Pregnancy and lactation therefore appear on several national warning lists. That history is a labeling input. It is not a food-supplement clearance for the root.
BfR flags possible interactions with antidiabetic, antihypertensive, and immunosuppressive medicines. [3] ANSES flags sedative and central-nervous-system depressant medicines and calls for caution with concomitant medicines more generally. [11] Poland’s Team warning is written on sedative, hypnotic, and antiepileptic medicines. [10]
A clinically studied root extract does not override those national texts.
What Brands Should Specify Before Requesting a Quote
The usable brief is a destination file. A global “root-only, 10–30 mg withanolides” line does not replace it.
The first three rows below are market-access inputs. The last three are manufacturing and quality-agreement inputs.
RFQ field | What to send | Why it changes the review |
|---|---|---|
| Destination markets | Sales countries and the product class (food supplement, complementary medicine, Ayush, or other) | Sets which texts, conditions, and warning sentences apply |
| Plant part | Root, leaf, root-and-leaf, or another named organ, with the binomial | Sets identity, the supplier file, and whether the destination treats the material as a different, or restricted, article |
| Ingredient specification | Extract ratio if used, withanolide definition, labelled percentage, and method | Sets whether the grade can be purchased and verified as written |
| Daily serving | Extract milligrams, units per serving, and the marker calculation | Sets whether the labelled portion sits inside a named national condition, such as the Polish Team figures |
| Label and dosage form | Current or reference label, format, and any warning already in artwork | Sets whether dose, format, and warning text conflict |
| Quality agreement | Incoming COA, identity method, and whether the finished unit will be assayed | Sets which tests sit with the supplier, the factory, or an outside laboratory |
Destination Market and Plant Part
Denmark is a do-not-place decision for food. [5] The Netherlands is still a notified draft. [8] Poland is a daily-portion and warning file for powdered root, read through a Team opinion. [10][20] France and Germany are population-advice files. [3][11] India is a root-only instruction with a petitioner-limited stay. [12][13][14] Australia is a species-level safety communication. [15]
A multi-country SKU needs one specification per market, or one specification that meets the strictest applicable lines. The raw-material line states Withania somnifera (L.) Dunal and the organ. Root and root-and-leaf remain different quotations. A “whole plant” or unspecified extract does not satisfy a root-only destination. Chromatographic fingerprinting against a root reference belongs in the supplier file when the destination treats leaf as a different material. [11][12][17]
Withanolide Assay and Daily-Serving Calculations
“Withanolides” and “withanolide glycosides” are different analyte definitions. HPLC and a non-specific spectrophotometric total are not interchangeable. If Poland is a destination, the recommended daily portion is read against both Team figures — powdered-root weight and withanolide milligrams — using the same definition. [10] If Poland is not a destination, the 10 mg figure is not reused as a general safety dose.
Label Warnings and Finished-Product Testing
Warning text comes from the destination. The Dutch draft wording, the Polish medicine and population sentences, the French and German population lists, and the TGA consumer symptoms are different texts. [3][8][10][11][15] Artwork that reserves space for “not for pregnancy” is not enough when the destination also names thyroid, liver, children, or named medicine classes.
A supplier certificate of analysis is incoming qualification. It does not automatically replace finished-unit testing. Whether the finished unit is assayed, for which marker, by which method, and against which limit, is set by the label claim, the quality agreement, and the destination file. That is a manufacturing decision. It is not a regulatory approval.
KS Nutripharma quotes ashwagandha supplements against the file below, not against a generic root claim.
Request an Ashwagandha Formula and Specification Review
Send the destination markets, the current label or formula sheet, and the supplier specification. The review looks at the stated plant part, the withanolide definition and method, the daily serving, and the manufacturing tests named in the brief.
A first review is more useful when it includes:
- Target sales countries and product class
- The named plant part
- Extract specification and the available COA
- Target amount per serving and the intended dosage form
- An existing label or reference product
The review identifies specification questions for further work. It does not replace market-specific legal advice, and it does not establish regulatory approval.
Request a Specification Review
Frequently Asked Questions
Is ashwagandha banned in the European Union?
No. There is no Union-wide prohibition and no Union-wide maximum daily intake. Denmark prohibits sale as food. Poland’s Team opinion records powdered-root and withanolide conditions. France and Germany have published population advice. The Netherlands has notified a draft. EMA did not adopt a herbal-medicine monograph for the root.
Does a root-only extract satisfy every European market?
It does not. Denmark’s published position covers the root. BfR and ANSES still advise named populations not to use ashwagandha supplements, including root preparations. A root line is necessary where the destination separates leaf from root. It is not sufficient where the destination restricts or cautions against the root itself.
Can a 5% withanolide extract be used in Poland?
Only if the recommended daily portion stays inside both Team figures — powdered root below 3 g per day and total withanolides at or below 10 mg — and a quantitative specification is on file. The extract percentage alone does not decide that.
Are the Dutch rules already in force?
No. TRIS 2026/0486/NL is a notified draft. The standstill ends on 7 December 2026. Until a final decree is adopted and a commencement date is set, the notified text is a proposal.
What does India’s court order mean for ashwagandha leaf products?
The 12 May 2026 interim stay applies only to the petitioners, until the next hearing. It is not a nationwide revocation of the April 2026 Ayush direction or the FSSAI advisory. Confirm whether the operator is covered, then read the current order. The last public order located for this draft is the 12 May 2026 stay.
What should a multi-country product specification include?
The destination list and product class, the plant part, the marker definition and method, the recommended daily portion in extract milligrams and in marker milligrams, the warning text required by each destination, and whether the finished unit will be assayed. A single “EU-compliant root extract” line does not replace those fields.
Technical and Regulatory References
- European Medicines Agency, Committee on Herbal Medicinal Products. Public statement on Withania somnifera (L.) Dunal, radix. EMA/HMPC/681519/2012. 9 July 2013. https://www.ema.europa.eu/en/medicines/herbal/withaniae-somniferae-radix
- Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, Annex III. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1925
- German Federal Institute for Risk Assessment (BfR). Ashwagandha: food supplements with potential health risks. Communication 39/2024. 10 September 2024. https://www.bfr.bund.de/cm/349/ashwagandha-food-supplements-with-potential-health-risks.pdf
- Klenow S, Latté KP, Wegewitz U, et al. Risikobewertung von Pflanzen und pflanzlichen Zubereitungen. 4. Withania somnifera (Schlafbeere). BfR-Wissenschaft 01/2012: 83–99. Cited in BfR Communication 39/2024.
- Danish Veterinary and Food Administration. Ashwagandha i kosttilskud og drikkevarer. https://foedevarestyrelsen.dk/kost-og-foedevarer/alt-om-mad/kemi-i-maden/mad-med-uoensket-kemi/ashwagandha
- DTU National Food Institute. Risikovurdering af roden fra Withania somnifera. 15 May 2020. https://foedevarestyrelsen.dk/Media/639171962718095885/Withania%20somnifera%20risikovurdering%2015%20maj%202020-a.pdf
- Ministerie van Volksgezondheid, Welzijn en Sport. Consultatieverslag: Wijziging van Warenwetregelgeving in verband met de aanwijzing van schadelijke stoffen in voedingssupplementen en kruidenpreparaten. 2025. https://www.internetconsultatie.nl/voedingssupplementen_en_kruidenpreparaten/document/16145
- European Commission. TRIS notification 2026/0486/NL. Amendment of the Commodities Act Decree on Herbal Preparations and the Commodities Act Decree on Food Supplements. Received 4 September 2026; end of standstill 7 December 2026. https://technical-regulation-information-system.ec.europa.eu/en/notification/28581
- National Institute for Public Health and the Environment (RIVM). Risk assessment of herbal preparations containing Withania somnifera (Ashwagandha). RIVM report 2024-0029. https://www.rivm.nl/bibliotheek/rapporten/2024-0029.pdf
- Główny Inspektorat Sanitarny, Zespół do spraw Suplementów Diety. Uchwała nr 7/2020 w sprawie Withania somnifera (L.) Dunal. https://www.gov.pl/attachment/7f475f81-7a77-42d3-a614-c9b87dcb6ff1
- ANSES. Avis relatif aux risques liés à l’utilisation des préparations de Withania somnifera (L.) Dunal dans les compléments alimentaires. Saisine 2021-SA-0077. 19 April 2024. https://www.anses.fr/fr/system/files/NUT2021SA0077.pdf
- Ministry of Ayush. Mandatory use of Ashwagandha (Withania somnifera) roots in Ayush products. T-13020/4/2022-DCC-Part(2). 15 April 2026. https://fssai.gov.in/upload/advisories/2026/04/69e0d84fcac2fAdvisory%20on%20non%20use%20of%20ashwagandha%20leaves%20in%20crude%20or%20extract%20or%20any%20other%20form%20in%20food%20products-%20reg.pdf
- Food Safety and Standards Authority of India. Advisory on non-use of ashwagandha leaves in crude or extract or any other form in food products. 16 April 2026. https://fssai.gov.in/upload/advisories/2026/04/Advisory_Ashwagandha_Leaves_16_04_2026.pdf
- High Court of Karnataka. Interim order in W.P. No. 14990/2026 and W.P. No. 15010/2026. 12 May 2026. https://www.livelaw.in/pdf_upload/2026/05/19/modified-interim-order-dated-12022026-1-674910.pdf
- Therapeutic Goods Administration. Medicines containing Withania somnifera (Withania, Ashwagandha). Safety advisory. 22 February 2024. https://www.tga.gov.au/news/safety-alerts/medicines-containing-withania-somnifera-withania-ashwagandha
- World Health Organization. WHO monographs on selected medicinal plants. Volume 4. Radix Withaniae. 2009. https://iris.who.int/bitstream/handle/10665/42052/9789241547055_eng.pdf
- ANSES. Procès-verbal de la réunion du 1er février 2024 du CES « Nutrition humaine ». Saisine 2021-SA-0077. https://www.anses.fr/system/files/NUT-PV-2024-02-01.pdf
- National Institutes of Health, Office of Dietary Supplements. Ashwagandha: Is it helpful for stress, anxiety, or sleep? Health Professional Fact Sheet. https://ods.od.nih.gov/factsheets/Ashwagandha-HealthProfessional/
- National Institute of Diabetes and Digestive and Kidney Diseases. Ashwagandha. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. https://www.ncbi.nlm.nih.gov/books/NBK548536/
- Główny Inspektorat Sanitarny. Zespół do spraw Suplementów Diety — table of plant-ingredient conditions, including Withania somnifera. https://www.gov.pl/web/gis/zespol-do-spraw-suplementow-diety
Related
Disclaimer
KS Nutripharma manufactures dietary supplements for brand owners. This article restates published national assessments, drafts, advisories, Team opinions, and court orders. It is not legal advice, not a medical assessment, and not a recommended intake. A notified draft is not in force until it is adopted. An advisory, a Team opinion, and an interim stay are not the same instrument. Regulatory status was checked on 22 October 2026 against the records listed above. The brand owner confirms the finished label and the rules of each destination market. KS confirms the specification it manufactures and the tests named in the quality agreement.
Written by KS Nutripharma Formulation Team | Reviewed by KS Nutripharma Director of R&D (PhD, Food Science | 19+ years nutraceutical development) | Technical review scope: plant-part identity versus destination texts; withanolide daily-portion arithmetic against the Polish Team figures; draft versus in-force instruments; petitioner-limited stay versus nationwide effect | Updated October 2026
Team background: KS Nutripharma
