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
9 study endpoints found for Niacinamide. 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 | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 600 mg/kg bw/day | oral | rabbit | Short Term Toxicity | COSMOS_DB |
| NOAEL | 800 mg/kg bw/day | oral | guinea pig | Short Term Toxicity | COSMOS_DB |
| NOAEL | 400 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| dose_tested | 600 mg/kg bw/day | oral | rabbit | Short Term Toxicity | COSMOS_DB |
| dose_tested | 800 mg/kg bw/day | oral | guinea pig | Short Term Toxicity | COSMOS_DB |
| NOAEL | 215 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 12.5 mg/kg bw/day | oral | - | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Workhorse brightening active with best-in-class safety and mechanistically unique position: inhibits melanosome transfer (not tyrosinase), making it complementary to every tyrosinase inhibitor and enabling additive combination formulas. 35–68% reduction in melanosome transfer in coculture models. Additionally reduces PGE2 and AGE formation that drive melanosome transfer. Japan quasi-drug since 2007. No EU or US restrictions at any cosmetic concentration. 2025 clinical data (Nature Sci Rep RCT): TXA 5% + niacinamide 4% combination outperformed 4% HQ for melasma with significantly fewer adverse reactions. Essential ingredient in any brightening formulation.
Regulatory Flags
Frequently Asked Questions
Is Niacinamide safe in cosmetics?
Workhorse brightening active with best-in-class safety and mechanistically unique position: inhibits melanosome transfer (not tyrosinase), making it complementary to every tyrosinase inhibitor and enabling additive combination formulas. 35–68% reduction in melanosome transfer in coculture models. Additionally reduces PGE2 and AGE formation that drive melanosome transfer. Japan quasi-drug since 2007. No EU or US restrictions at any cosmetic concentration. 2025 clinical data (Nature Sci Rep RCT): TXA 5% + niacinamide 4% combination outperformed 4% HQ for melasma with significantly fewer adverse reactions. Essential ingredient in any brightening formulation. The EU classifies Niacinamide as "permitted". Safety rating: EXCELLENT. 9 toxicological study endpoint(s) are available in our database.
Is Niacinamide allowed in the EU?
Niacinamide EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Niacinamide do in cosmetics?
Niacinamide functions as: Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of melanosomes from melanocytes to keratinocytes (35–68% inhibition in coculture); also reduces keratinocyte PGE2 production and AGE formation, both of which stimulate melanosome transfer; does not affect tyrosinase catalytic activity. It is classified as a Active Ingredient in our database. CAS number: 98-92-0.
What is the Margin of Safety for Niacinamide?
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 Niacinamide?
The NOAEL (No Observed Adverse Effect Level) for Niacinamide is 1000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.
Is Niacinamide classified as hazardous under GHS?
Niacinamide carries a GHS signal word of "WARNING". Hazard statements: Causes eye irritation. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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