Black Cohosh
INCI: Actaea racemosa
Black Cohosh (Actaea racemosa) is a botanical extract from the root of a North American perennial plant, traditionally used in herbal wellness practices. In private-label gummy manufacturing, it is positioned for women's health and hormonal balance during menopause. As a botanical on the EFSA on-hold list, it carries no authorised EU health claims under Reg. (EU) 432/2012.
- women's health, hormonal balance, menopause support
At a glance
- Definition
- Black Cohosh (Actaea racemosa) is a botanical extract from the root of a North American perennial plant, traditionally used in herbal wellness practices. In private-label gummy manufacturing, it is positioned for women's health and hormonal balance during menopause. As a botanical on the EFSA on-hold list, it carries no authorised EU health claims under Reg. (EU) 432/2012.
- Common positionings
- Menopause comfort
- Hot flash relief
- Night sweat management
- Mood balance during menopause
- Hormonal transition support
- Format suitability
- Reviewed for gummies and sachets — confirmed per project.
Where this ingredient fits in the DAT Supply catalogue
Every format chip links through to its manufacturing hub and to the private-label catalogue for that format. The category chip routes to the matching vertical hub on the categories index.
- Botanicals & mushrooms
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What it is
Black Cohosh (Actaea racemosa) is a botanical extract derived from the root of a perennial plant native to eastern North America. It has been used in traditional herbal wellness practices for generations, particularly in the context of women's health during the menopausal transition. In modern nutraceutical manufacturing, Black Cohosh is typically supplied as a dried root extract standardised to triterpene glycosides, the active marker compounds.
Brands choose Black Cohosh for gummy formats because it addresses a well-defined consumer need — menopause comfort and hormonal balance — in a category that remains underserved in gummy form. The ingredient's strong consumer recognition, combined with its compatibility with gummy processing, makes it a commercially viable addition to women's health ranges. DAT Supply works with suppliers who provide standardised extracts suitable for gummy and sachet formats.
Origin and history
Black Cohosh has a documented history of traditional use among Native American tribes, who used the root for various wellness purposes. European settlers adopted the plant into their herbal practices, and by the 19th century it was listed in the United States Pharmacopeia. Its common name derives from the dark colour of the dried root, and "cohosh" is an Algonquian word meaning "rough" or "bumpy," referring to the root's appearance.
Today, commercial Black Cohosh is primarily wild-crafted or cultivated in the Appalachian region of the United States. Industrial production involves harvesting the root after three to five years of growth, drying, and extracting with ethanol or water to produce a standardised extract. The extract is then spray-dried into a powder suitable for encapsulation, tableting, or incorporation into gummy formulations.
Scientific overview
The primary active constituents in Black Cohosh are triterpene glycosides, including actein and cimifugoside. These compounds are believed to interact with serotonin receptors and modulate neurotransmitter activity, which may contribute to the ingredient's traditional use for temperature regulation and mood balance during menopause. Unlike soy isoflavones, Black Cohosh does not appear to have direct oestrogenic activity, which distinguishes its mechanism from phytoestrogen-based botanicals.
Bioavailability of triterpene glycosides from oral administration is considered moderate. Standardisation of extracts to a consistent percentage of triterpene glycosides (typically 2.5% to 5%) is important for batch-to-batch reproducibility. The powdered extract is heat-stable and soluble in gummy processing, though the bitter taste requires careful flavour masking with fruit-forward profiles such as berry or pomegranate.
Manufacturing watchpoints include the potential for hepatotoxicity in rare cases, which has led to regulatory caution in some markets. DAT Supply reviews supplier documentation for heavy metal testing, microbial limits, and solvent residues per project. The cost-per-mg is mid-tier, making Black Cohosh suitable for gummy formulations where the target dose of 40 mg to 160 mg per serving is achievable within reasonable raw material cost.
Why brands use Black Cohosh
Black Cohosh is one of the most familiar and commercially understood botanical actives for women's health across EU and US markets. The menopause wellness category is growing, and gummy formats offer a consumer-friendly alternative to tablets or capsules, particularly for women seeking a more pleasant daily supplement experience. Black Cohosh gummies can be positioned alongside other women's health ingredients such as Vitex, Sage, or Soy Isoflavones to create comprehensive hormonal balance formulations.
From a formulation perspective, Black Cohosh extract is heat-stable and soluble in gummy processing, which simplifies manufacturing. The primary challenge is taste — the bitter, earthy profile requires robust flavour masking. DAT Supply recommends fruit-forward profiles and may adjust sweetness levels to achieve acceptable organoleptic properties. The standardised extract form ensures consistent dosing per gummy, and the mid-tier cost allows for commercially viable retail pricing.
For pack copy in EU markets, brands must remember that Black Cohosh is a botanical on the EFSA on-hold list with no authorised health claims under Reg. (EU) 432/2012. Claim wording should avoid disease or treatment language. Brands may use non-health claim positioning such as "traditionally used in herbal wellness" or co-formulate with nutrients carrying authorised claims (e.g., Vitamin B6 for hormonal activity regulation). DAT reviews claim strategy per project with regulatory counsel and confirms certification status per project and batch before final label claims.
Formats this ingredient is reviewed for
DAT Supply covers gummy, capsule, softgel, tablet, powder, oral strip, liquid drop, shot, jelly and pet formats. The list below reflects every format this ingredient is reviewed for — chips link through to the manufacturing hub for each format. Final compatibility, dose and matrix are confirmed per project.
Formulation notes
Verified formulation reference across the formats this ingredient is reviewed for — the Supported formats section lists every product format this active is approved for, and the per-format Considerations section below covers matrix-specific guidance. Final formulation, dose and on-pack copy are confirmed per project.
- Gummy fit
- Good
- Heat stable
- Yes
- Soluble in matrix
- Yes
- Cost tier
- Medium
Forms available
- Dried root extract (standardised to triterpene glycosides), powdered root
Dosage reference
Brand positioning typically ranges from 40 mg to 160 mg per serving. No EU NRV established for botanicals. DAT confirms final dosage per project based on target market and claim strategy.
Taste & sensory
Bitter, earthy. Masking required in gummy formats — fruit-forward profiles (berry, pomegranate) recommended.
Manufacturing notes
Gummy-optimised dosing and format considerations. Standardised extract preferred for consistent triterpene glycoside content. Bitter taste requires robust flavour masking.
Per-format formulation notes
Safe-baseline considerations for each format this ingredient is reviewed for. Final formulation, dose and on-pack copy are confirmed per project.
Gummies
- Taste masking and aroma load against the cooked-base flavour — confirmed per project.
- Heat exposure during cooking; coated or encapsulated forms may be required — confirmed per project.
- Matrix choice (pectin vs gelatin) and its effect on ingredient stability — confirmed per project.
- Per-gummy dose and serving count needed to hit the label claim — confirmed per project.
Sachets
- Powder flow and dose accuracy at single-serve sachet weights — confirmed per project.
- Barrier requirements (oxygen, moisture) for the active — confirmed per project.
- Reconstitution behaviour when the sachet is dosed into water — confirmed per project.
EU-authorised health claims
EU-authorised wording for this ingredient is reviewed per project against Reg. 1924/2006 and the authorised list under Reg. 432/2012. No final claim wording is implied by this page.
Authorised at ≥15% NRV per daily serving. Claim wording must appear verbatim on consumer packaging. DAT reviews final pack copy per project against EU 1924/2006 and the authorised list under EU 432/2012.
Black Cohosh is a botanical on the EFSA on-hold list. No authorised health claims under Reg. (EU) 432/2012. Brands may use non-health claim positioning (e.g., 'traditionally used in herbal wellness') or co-formulate with nutrients carrying authorised claims. DAT reviews claim strategy per project with regulatory counsel.
Studies & evidence
External peer-reviewed sources and regulatory opinions. Citations only — DAT does not endorse the publishers.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)·EFSA Journal·2010
Leach MJ, Moore V·Cochrane Database of Systematic Reviews·2012
Dugoua JJ, Seely D, Perri D, Koren G, Mills E·Canadian Journal of Clinical Pharmacology·2006
Nuntanakorn P, Jiang B, Yang H, et al.·Journal of Natural Products·2006
Teschke R, Bahre R, Genthner A, et al.·Regulatory Toxicology and Pharmacology·2009
Product concepts featuring Black Cohosh
Private-label product concepts where Black Cohosh appears in the formula. Each opens to a product brief and quote route.
Synergies & conflicts
Pairs well with
Pairs with Vitex (hormonal balance), Sage (hot flashes), Soy Isoflavones (phytoestrogen).
Care when combining with
Hepatotoxicity rare but possible — monitor liver function. Contraindicated with hormone-sensitive cancers.
Similar ingredients
Ingredients that frequently sit alongside this one in private-label supplement briefs.

Aloe Vera
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Artichoke
Artichoke (Cynara scolymus) is a botanical ingredient used in dietary supplements for its traditional association with digestive and liver function. It is one of the most familiar and commercially understood botanical actives across EU and US markets. As a botanical on the EU on-hold list, no authorised health claims are currently permitted under Reg. 432/2012.

Arugula Extract
Arugula extract is a botanical ingredient derived from Eruca sativa leaves, used in gummy and sachet formats for green superfood and daily wellness positioning. It is a botanical on the EFSA on-hold list with no authorised health claims under Reg. (EU) 432/2012. Any claim coverage must come from co-formulated nutrients.

Ashwagandha
Ashwagandha (Withania somnifera) is a traditional Ayurvedic root used historically for stress, vitality, and sleep. In gummy formats it is most commonly positioned within stress-and-calm or sleep stacks. Ashwagandha sits on the EFSA "on-hold" list of botanical claims, with no authorised EU health claims of its own; substantiated claim wording in Ashwagandha gummies typically derives from co- formulated nutrients such as Magnesium and Vitamin B6.

Bacopa Extract
Bacopa Extract (Bacopa monnieri) is a botanical ingredient traditionally used in Ayurvedic wellness systems. In private-label gummy manufacturing, it is positioned for cognitive support, memory, and stress resilience. Bacopa has no EFSA-authorised health claims under Reg. 432/2012; claim coverage for cognitive function relies on co-formulated nutrients such as Vitamin B6, B12, or Iron.

Bamboo Extract
Bamboo extract is a plant-derived ingredient standardised for silica content, sourced from Bambusa vulgaris. It is used in gummy and sachet formulations as a natural source of silicon, a mineral involved in connective tissue structure. Under EU Regulation 432/2012, bamboo extract carries no authorised health claims; brands typically co-formulate with Biotin, Zinc, or Vitamin C for hair, skin, and nails positioning.
Adjacent reading
Pairings, resource guides and blog notes most often associated with Black Cohosh on DAT Supply briefs.
Develop a formula featuring Black Cohosh
A ready white-label formula exists — open a product brief, or talk to our team to align the launch plan.