Kojic Acid
INCI: KOJIC ACID
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Kojic Acid. 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 | =227 mg/kg/day | oral | rat (male) | chronic | CIR |
| LOAEL | 5.84999990463 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | =6 mg/kg/day | oral | rat (male) | repeat-dose | SCCS |
| NOAELadj | =2 mg/kg/day | oral | rat (male) | repeat-dose | SCCS |
| NOAEL | =150 mg/kg/day | oral | rat | subchronic | SCCS |
| NOAEL | 23.8 mg/kg bw/day | oral | - | - | SCCS_PDF_extraction |
| NOAEL | 5.85 mg/kg bw/day | oral | - | - | SCCS_PDF_extraction |
| NOAEL | 6 mg/kg bw/day | - | - | - | SCCS_PDF_extraction |
| NOAEL | 62.5 mg/kg bw/day | - | - | - | SCCS_PDF_extraction |
| NOAEL | 6 mg/kg bw/day | oral | - | reproductive | SCCS_PDF_extraction |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
al endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ko
al endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ko
al endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ko
al endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ko
al endocrine disrupting properties of Kojic acid, the SCCS is of the opinion that Kojic acid is safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ko
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Kojic Acid.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 6 mg/kg/day | 23.8 mg/kg/day | Oral | Rat (male) | Repeated dose (28-day) (28 days (dietary)) | 100 | SCCS/1637/21 (2022) |
| 15.5 mg/kg/day | - | Oral | Rat (male) | Subacute/repeated dose (20-week feeding) (20 weeks (dietary)) | 100 | SCCS/1637/21 (2022) |
| 100 mg/kg/day | - | Dermal | Rat (Wistar) | Repeated dose (28-day) (28 days) | N/A | SCCS/1098/14 (2014) |
| - | - | Oral | Rat/Mouse | Developmental toxicity (Gestational period) | 100 | SCCS/1098/14 (2014) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Kojic Acid, relevant to systemic exposure and MoS calculations.
Source: J Cosmet Dermatol 2011
Expert Verdict
Clinically effective copper-chelating tyrosinase inhibitor with decades of use for melasma and senile pigmentation at 1–2.5%. EU-restricted to 1% in face and hand products under Regulation 2024/996 (placement deadline 1 November 2025; withdrawal deadline 1 May 2027). Japan quasi-drug since 1988; suspended 2003 over rodent liver tumour data; reinstated 2005 after transdermal exposure confirmed negligible at 1% (peak plasma 1.54 ng/mL). Two persistent clinical challenges: aqueous oxidation instability requiring pH optimization, antioxidant co-formulants, or anhydrous vehicles; and contact sensitization in approximately 1–2% of users—a meaningful rate for leave-on products. Kojic acid dipalmitate ester addresses both liabilities at the cost of slower bioactivation. Effective within constraints but requires careful concentration and formulation engineering.
Regulatory Flags
Frequently Asked Questions
Is Kojic Acid safe in cosmetics?
Clinically effective copper-chelating tyrosinase inhibitor with decades of use for melasma and senile pigmentation at 1–2.5%. EU-restricted to 1% in face and hand products under Regulation 2024/996 (placement deadline 1 November 2025; withdrawal deadline 1 May 2027). Japan quasi-drug since 1988; suspended 2003 over rodent liver tumour data; reinstated 2005 after transdermal exposure confirmed negligible at 1% (peak plasma 1.54 ng/mL). Two persistent clinical challenges: aqueous oxidation instability requiring pH optimization, antioxidant co-formulants, or anhydrous vehicles; and contact sensitization in approximately 1–2% of users—a meaningful rate for leave-on products. Kojic acid dipalmitate ester addresses both liabilities at the cost of slower bioactivation. Effective within constraints but requires careful concentration and formulation engineering. The EU classifies Kojic Acid as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Kojic Acid allowed in the EU?
Kojic Acid EU regulatory status: restricted. Maximum allowed concentration: 1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Kojic Acid do in cosmetics?
Kojic Acid functions as: Tyrosinase inhibitor; chelates copper at the enzyme's active site blocking both monophenolase and diphenolase activity; clinically used at 1–2.5% for melasma and senile pigmentation. It is classified as a Active Ingredient in our database. CAS number: 501-30-4.
What is the Margin of Safety for Kojic Acid?
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 Kojic Acid?
The NOAEL (No Observed Adverse Effect Level) for Kojic Acid is =227 mg/kg/day based on a chronic study via oral route in rat (male). A total of 10 study endpoints are available. Source: CIR.
Compliance Tools
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