Is Niacinamide safe in cosmetics?
Niacinamide has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
EXCELLENT
Active Ingredient
Niacinamide
INCI: NIACINAMIDE
Niacinamide (CAS 98-92-0) is a cosmetic active ingredient functioning as Melanosome transfer inhibitor; vitamin B3 amide; inhibits transfer of. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical 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.
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
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
3772
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 used outside cosmetics?
Niacinamide also appears in pharmaceutical 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
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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Is Niacinamide in Your Products?
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