Excellent Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Fumaric Acid

INCI: FUMARIC ACID

CAS Number
110-17-8
Function
Buffering agent, pH adjuster, fragrance ingredient
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes GRAS under 21 CFR 172.350 and FEMA GRAS as flavoring. No FDA cosmetic restrictions. CIR 2009 final safety assessment on file.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Fumaric 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 1250 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 400 mg/kg bw/day oral guinea pig Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 600 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rabbit Subchronic COSMOS_DB
NOAEL 1500 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 2070 mg/kg bw/day oral rabbit Subchronic COSMOS_DB
NOAEL 2786 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 2786 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
dose_tested 1250 mg/kg bw/day oral dog Chronic COSMOS_DB

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 Harmful to aquatic life
Short-term Exposure Effects
The substance is irritating to the eyes.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir March 23, 2009
Verdict: unknown

Expert Verdict

Safe pH-buffering and fragrance ingredient with endogenous status. CIR 2009 safety assessment supports safe use. GRAS food status, no EU restrictions, non-irritating, non-sensitizing, negative genotoxicity.

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Concern Level: None

Regulatory Flags

endogenous cir-safe gras ph-adjuster no-mos-required dmf-confusion-risk epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Fumaric Acid safe in cosmetics?

Safe pH-buffering and fragrance ingredient with endogenous status. CIR 2009 safety assessment supports safe use. GRAS food status, no EU restrictions, non-irritating, non-sensitizing, negative genotoxicity. The EU classifies Fumaric Acid as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Fumaric Acid allowed in the EU?

Fumaric Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Fumaric Acid do in cosmetics?

Fumaric Acid functions as: Buffering agent, pH adjuster, fragrance ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 110-17-8.

What is the Margin of Safety for Fumaric 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 Fumaric Acid?

The NOAEL (No Observed Adverse Effect Level) for Fumaric Acid is 1250 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Fumaric Acid classified as hazardous under GHS?

Fumaric Acid carries a GHS signal word of "WARNING". Hazard statements: Causes eye irritation Harmful to aquatic life. 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 โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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