Is Niacinamide safe in cosmetics?
Niacinamide has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Niacinamide
Also known as: Nicotinamide, 3-Pyridinecarboxamide, Nam, EINECS 202-713-4, Pyridine, 3-carbamoyl- (+15 more)
INCI: NIACINAMIDE
Niacinamide (CAS 98-92-0) is a cosmetic active ingredient functioning as Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of. NOAEL 12.5 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Function
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
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No FDA concentration restriction. Used at 2–10% in OTC brightening and barrier products without drug classification concerns. Not listed in OTC skin-bleaching monograph (21 CFR 310.545). Generally recognised as safe in dietary context; topical cosmetic use unrestricted.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Niacinamide.
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
WARNING
Hazard Statements
Causes eye irritation
Short-term Exposure Effects
The substance is irritating to the eyes.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Niacinamide across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
4 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >2000 mg/kg | Rabbit | dermal | acute | ECHA |
| NOAEL | =215 mg/kg-day | Rat | oral | short-term | HESS |
| LD50 | =2500 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =3500 mg/kg | Rat | oral | - | ChemIDplus |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα (skin penetration enhancer – enhances paraben absorption)
LOEC: N/A
EU status: allowed
indirect (enhances dermal absorption of co-formulated EDCs)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 5.0
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | restricted | - | All products |
| AU | therapeutic_good | - | skin treatment |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vivo | 2.2 | In vivo (human) | Human in vivo | Kasting & Miller 2006 (2006) |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 2–5 | 10 | CIR Safety Assessment |
| Serum | 2–10 | 20 | CIR Safety Assessment |
| Toner | 2–5 | 10 | CIR Safety Assessment |
| Eye Cream | 2–5 | 10 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Humectant
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Niacinamide — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
brightening
melanosome-transfer-inhibitor
vitamin-b3
35-68pct-transfer-inhibition
pge2-reduction
age-formation-reduction
not-tyrosinase-direct
synergistic-txa
synergistic-tyrosinase-inhibitors
quasi-drug-japan-2007
no-restrictions-any-market
melasma
pih
combination-backbone
eu-allowed
us-allowed
fda_food_additive
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 2.2 | In vivo (human) | Standard cosmetic formulation |
Known Synonyms
Nicotinamide
3-Pyridinecarboxamide
Nam
EINECS 202-713-4
Pyridine, 3-carbamoyl-
Nicotinsaureamid
UNII-25X51I8RD4
Acid amide
Amid kyseliny nikotinove
Amide PP
Amixicotyn
Amnicotin
Austrovit PP
Dipegyl
Dipigyl
Endobion
Factor pp
Hansamid
Inovitan PP
Mediatric
Chemical Function
Humectant
Softener and conditioner
Regulatory Lists
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; consumer_product; Substances in Products - Canada (4/2014)
inert_ingredient; non_food_use; Pesticides
pharmaceutical
Europe; supplements
Europe; food_additive; supplements
Canada; pharmaceutical
Canada; pharmaceutical
inert_ingredient; non_food_use; Pesticides
Australian Status
AICIS status: listed
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
NIACINAMIDE
ChEMBL ID
CHEMBL1140
Max Phase
4
Adverse Event Associations
3772
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Niacinamide
Food Category
preservative
Frequently Asked Questions
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.
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.
Is Niacinamide used outside cosmetics?
Niacinamide also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Niacinamide compliance across multiple jurisdictions:
Ingredient Decoder
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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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