Regulatory Status
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Safety Data
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Toxicological Studies
2 study endpoints found for Genistein. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | =0.3 mg/kg/day | oral | rat (Sprague-Dawley) | reproductive | SCCS |
| NOAEL | >50 mg/kg/day | oral | rat | subchronic | SCCS |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein
e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein
e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein
e and justified than the data from oral studies. The SCCS considers that the calculation of margin of safety (MoS) for daidzein based on the data from subcutaneous route would provide a more reliable indicator of SCCS/1641/22 Final version Corrigendum October 2022 Opinion on genistein and daidzein
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Genistein.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 50 mg/kg/day | 150 mg/kg/day | Oral | Rat (Sprague-Dawley) | Developmental/reproductive (Gestational/neonatal period) | 20 | SCCS/1641/22 (2022) |
Expert Verdict
Genistein, the principal isoflavone from soy, operates through dual mechanisms in hair loss: 5α-reductase inhibition (reducing DHT) and estrogen receptor modulation (phytoestrogenic effect providing follicle-protective benefits). Particularly relevant to postmenopausal FPHL where estrogen decline activates DHT-mediated follicle miniaturization. Evidence is primarily in vitro and limited human studies; FPHL-specific large RCTs are lacking. SCCS calculated adequate margin of safety (≥100) at 0.007%. Phytoestrogenic activity requires careful claim positioning in EU cosmetics to avoid medicinal product classification. GOOD safety profile at cosmetic use levels.
Regulatory Flags
Frequently Asked Questions
Is Genistein safe in cosmetics?
Genistein, the principal isoflavone from soy, operates through dual mechanisms in hair loss: 5α-reductase inhibition (reducing DHT) and estrogen receptor modulation (phytoestrogenic effect providing follicle-protective benefits). Particularly relevant to postmenopausal FPHL where estrogen decline activates DHT-mediated follicle miniaturization. Evidence is primarily in vitro and limited human studies; FPHL-specific large RCTs are lacking. SCCS calculated adequate margin of safety (≥100) at 0.007%. Phytoestrogenic activity requires careful claim positioning in EU cosmetics to avoid medicinal product classification. GOOD safety profile at cosmetic use levels. The EU classifies Genistein as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Genistein allowed in the EU?
Genistein EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Genistein do in cosmetics?
Genistein functions as: 5-alpha-reductase inhibitor; phytoestrogen; ER modulator; anti-androgenic; antioxidant; hair-growth active. It is classified as a Active Ingredient in our database. CAS number: 446-72-0.
What is the Margin of Safety for Genistein?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Genistein?
The NOAEL (No Observed Adverse Effect Level) for Genistein is =0.3 mg/kg/day based on a reproductive study via oral route in rat (Sprague-Dawley). A total of 2 study endpoints are available. Source: SCCS.
Compliance Tools
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