Is Genistein safe in cosmetics?
Genistein has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by SCCS Opinion.
Genistein
Also known as: 4H-1-Benzopyran-4-one, 5,7-dihydroxy-3-(4-hydroxyphenyl)-, 5,7-Dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone, Isoflavone, 4',5,7-trihydroxy-, 4',5,7-Trihydroxyisoflavone, GeniVida (+14 more)
INCI: GENISTEIN
Genistein (CAS 446-72-0) is a cosmetic active ingredient functioning as 5-alpha-reductase inhibitor; phytoestrogen; ER modulator; anti-androgenic;. NOAEL 4 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 4 safety opinions reviewed (SCCS Opinion). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
Function
5-alpha-reductase inhibitor; phytoestrogen; ER modulator; anti-androgenic; antioxidant; hair-growth active
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted cosmetic active. No OTC drug monograph. Phytoestrogenic mechanism means claim language requires care to avoid drug classification.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Genistein.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 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 | =4 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =4 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =4 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =4 mg/kg bw/day | oral | - | NOAEL study | SCCS Opinion |
| NOAEL | =5 mg/kg bw/d | - | human | reproductive toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg | oral | rat | reproductive toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/d | - | human | reproductive toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg | oral | rat | reproductive toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg bw/d | - | human | reproductive toxicity | SCCS Opinion |
| NOAEL | =5 mg/kg | oral | rat | reproductive toxicity | SCCS Opinion |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
SCCS Opinion
SCCS/1641/2022
16 September 2022
Verdict: safe
NOAEL: 4 mg/kg bw/day (subcutaneous)
Max Concentration: 0.007% in general
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 Opinion
SCCS/1641/2022
16 September 2022
Verdict: safe
NOAEL: 4 mg/kg bw/day (subcutaneous)
Max Concentration: 0.02% in general
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 Opinion
SCCS/1641/2022
16 September 2022
Verdict: safe
NOAEL: 35 mg/kg (not specified)
Max Concentration: 0.007% in general
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 Opinion
SCCS/1641/2022
16 September 2022
Verdict: safe
NOAEL: 35 mg/kg (not specified)
Max Concentration: 0.02% in general
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
Pre-Calculated Safety Assessment
Conditional — safe only within SCCS limits: genistein <=0.007%
Pre-calculated NOAEL → SED → MoS audit trail for Genistein across SCCS product categories, with measured dermal absorption where available.
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) |
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
100%
DPRA Lys %
16.03%
KeratinoSens IC50
180.191 µM
hCLAT CV75
81 µg/mL
GHS: inconclusive
Source: DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Under investigation
Evidence: Moderate
(2024)
Health effects: Yes
Affected pathways: Estrogenic (phytoestrogen)
Regulatory framework: Cosmetics
Source list: II (former)
Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα, ERβ, AR, PPAR-gamma
LOEC: 1 nM
EU status: restricted (max 0.01% leave-on; max 0.2% rinse-off; EU 2024/996)
agonist (ERα, ERβ, PPARγ); antagonist (AR)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| UK | restricted | - | - |
| ASEAN | restricted | Updated concentration limits per 2025–2026 ACD revision | Cosmetic products as active |
| MY | restricted (updated limits) | Updated per ACD 2025 revision — lower than previous | All cosmetic products using as active |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Softener and conditioner
Editorial summary
Preliminary editorial summary for Genistein — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
hair-growth-active
5ar-inhibitor
phytoestrogen
anti-androgenic
soy-derived
claim-sensitive
cosmetic-classified
endocrine_disruptor
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Genistein by CAS number or substance name.
Studies
44
Lowest NOAEL
4
Highest NOAEL
2000
Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg
SCCS Opinion
Known Synonyms
4H-1-Benzopyran-4-one, 5,7-dihydroxy-3-(4-hydroxyphenyl)-
5,7-Dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone
Isoflavone, 4',5,7-trihydroxy-
4',5,7-Trihydroxyisoflavone
GeniVida
Genistin aglycone
SIPI 807-1
Climagen F
C.I. 75610
FW 635I-2
5-18-04-00594
BRN 0263823
EINECS 207-174-9
UNII-DH2M523P0H
4',5, 7-Trihydroxyisoflavone
4',5,7-Trihydroxy-Isoflavone
4,5,7-Trihydroxy Iso-Flavone
5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one
Differenol A
Chemical Function
Softener and conditioner
Regulatory Lists
Canada; pharmaceutical
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
GENISTEIN
ChEMBL ID
CHEMBL44
Max Phase
2
Adverse Event Associations
7
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Genistein
Food Category
preservative
Frequently Asked Questions
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 NOAEL for Genistein?
The NOAEL (No Observed Adverse Effect Level) for Genistein is =4 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is Genistein used outside cosmetics?
Genistein also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Genistein compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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