Good Antioxidant NOAEL Data SCCS/CIR Reviewed

Butylated Hydroxyanisole

INCI: BHA

CAS Number
25013-16-5
Function
Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product preservative against oxidative degradation in oils and waxes
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.07%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA: GRAS for food use (21 CFR 172.110). No specific cosmetic concentration limit under 21 CFR; manufacturer safety assessment responsibility. CIR Final Amended Report (Sep 2024): under review. California Prop 65 listed carcinogen (NSRL 4000 ยตg/day) โ€” warning required for intentional exposure products in CA if threshold exceeded.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Butylated Hydroxyanisole. 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 2000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2000 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 1200 mg/kg bw/day oral hamster Subchronic COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 250 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 1200 mg/kg bw/day oral hamster Subchronic COSMOS_DB
NOAEL 125 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 250 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB

Safety Opinions

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

sccs SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (oral)
sccs SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (dermal)
sccs SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 100 mg/kg bw/d (oral)
sccs SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (not specified)
sccs SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 55 mg/kg bw/d (not specified)

Expert Verdict

SCCS/1682/25 (Oct 30, 2025, preliminary): safe at โ‰ค0.07% in leave-on and rinse-off products with margin of safety 610โ€“17,251, all exceeding threshold of 100. Weak anti-estrogenic/anti-androgenic signals in vitro/in vivo at high doses; EDC concern flagged. Excluded from oral care and inhalation products. California Prop 65 listed carcinogen.

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Concern Level: Moderate

Regulatory Flags

endocrine-concern sccs-assessed prop-65 antioxidant synthetic eu-restriction-pending edc-flagged oral-excluded endocrine_disruptor prop65 ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Butylated Hydroxyanisole safe in cosmetics?

SCCS/1682/25 (Oct 30, 2025, preliminary): safe at โ‰ค0.07% in leave-on and rinse-off products with margin of safety 610โ€“17,251, all exceeding threshold of 100. Weak anti-estrogenic/anti-androgenic signals in vitro/in vivo at high doses; EDC concern flagged. Excluded from oral care and inhalation products. California Prop 65 listed carcinogen. The EU classifies Butylated Hydroxyanisole as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Butylated Hydroxyanisole allowed in the EU?

Butylated Hydroxyanisole EU regulatory status: restricted. Maximum allowed concentration: 0.07%. This is based on EU Regulation 1223/2009 and its amendments.

What does Butylated Hydroxyanisole do in cosmetics?

Butylated Hydroxyanisole functions as: Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product preservative against oxidative degradation in oils and waxes. It is classified as a Antioxidant in our database. CAS number: 25013-16-5.

What is the Margin of Safety for Butylated Hydroxyanisole?

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 Butylated Hydroxyanisole?

The NOAEL (No Observed Adverse Effect Level) for Butylated Hydroxyanisole is 2000 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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