Good Antioxidant NOAEL Data SCCS/CIR Reviewed

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

🇪🇺 EU Status restricted
EU Max Conc. 0.07%
🇺🇸 US Status permitted
US Notes FDA GRAS for food use (21 CFR 182.3173). CIR Final Amended Report (Sep 2024) under regulatory review with formal conclusion pending. No specific cosmetic concentration limit under 21 CFR. California Prop 65 listed carcinogen (CAS 25013-16-5, NSRL 4000 µg/day) — 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 BHA. 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 2025, preliminary): safe at ≤0.07% in leave-on and rinse-off products with all MoS values exceeding threshold of 100. Weak anti-estrogenic and anti-androgenic signals demonstrated in vitro and in vivo at high doses with insufficient data for point-of-departure; EDC concern formally flagged by SCCS. EU restriction forthcoming at ≤0.07%. California Prop 65 listed carcinogen. CIR FAR Sep 2024 under review. More regulatory concern than BHT due to stronger EDC signals. Oral care and inhalation products excluded. Reformulation pressure increasing in EU.

⚠️
Concern Level: Moderate

Regulatory Flags

antioxidant synthetic eu-restricted endocrine-concern edc-flagged prop-65 cir-review-pending set-hat-mechanism chain-breaking oral-excluded reformulation-pressure sccs-reviewed prop65 ifra_fragrance fda_food_additive

Frequently Asked Questions

Is BHA safe in cosmetics?

SCCS/1682/25 (Oct 2025, preliminary): safe at ≤0.07% in leave-on and rinse-off products with all MoS values exceeding threshold of 100. Weak anti-estrogenic and anti-androgenic signals demonstrated in vitro and in vivo at high doses with insufficient data for point-of-departure; EDC concern formally flagged by SCCS. EU restriction forthcoming at ≤0.07%. California Prop 65 listed carcinogen. CIR FAR Sep 2024 under review. More regulatory concern than BHT due to stronger EDC signals. Oral care and inhalation products excluded. Reformulation pressure increasing in EU. The EU classifies BHA as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is BHA allowed in the EU?

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

What does BHA do in cosmetics?

BHA 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 BHA?

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 BHA?

The NOAEL (No Observed Adverse Effect Level) for BHA 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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