Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

BHA (Butylated Hydroxyanisole)

INCI: BUTYLATED HYDROXYANISOLE

CAS Number
25013-16-5
Function
Antioxidant that prevents lipid oxidation in oil-phase formulations
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; GRAS for food (21 CFR 182.3169); permitted in cosmetics

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for BHA (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

Tier 4 โ€” High Risk / Data Gap

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Concern Level: High

Regulatory Flags

prop65 ifra_fragrance fda_food_additive

Frequently Asked Questions

Is BHA (Butylated Hydroxyanisole) safe in cosmetics?

Tier 4 โ€” High Risk / Data Gap The EU classifies BHA (Butylated Hydroxyanisole) as "prohibited". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is BHA (Butylated Hydroxyanisole) allowed in the EU?

BHA (Butylated Hydroxyanisole) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does BHA (Butylated Hydroxyanisole) do in cosmetics?

BHA (Butylated Hydroxyanisole) functions as: Antioxidant that prevents lipid oxidation in oil-phase formulations. It is classified as a cosmetic ingredient in our database. CAS number: 25013-16-5.

What is the Margin of Safety for BHA (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 BHA (Butylated Hydroxyanisole)?

The NOAEL (No Observed Adverse Effect Level) for BHA (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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