Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

BHA (Butylated Hydroxyanisole)

Also known as: (1,1-Dimethylethyl)-4-methoxyphenol, 1,1-(Dimethylethyl)-4-methoxyphenol, Phenol, tert-butyl-4-methoxy-, terc-butil-4-metoxifenol, tert-Butyl-4-hydroxyanisole (+15 more)

INCI: BUTYLATED HYDROXYANISOLE

BHA (Butylated Hydroxyanisole) (CAS 25013-16-5) is a cosmetic cosmetic ingredient functioning as Antioxidant that prevents lipid oxidation in oil-phase formulations. NOAEL 50 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited; 5 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 25013-16-5 →

Auto-generated CPSR Part A draft with source citations
Function
Antioxidant that prevents lipid oxidation in oil-phase formulations
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
246-563-8

Regulatory Status

EU EU Status prohibited
US US Status permitted
US Notes Permitted; GRAS for food (21 CFR 182.3169); permitted in cosmetics

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for BHA (Butylated Hydroxyanisole).

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 =220 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR_vision_codex
NOAEL 50 mg/kg bw/day oral swine Subchronic COSMOS_DB
NOAEL 60 mg/kg bw/day oral dog Subchronic 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)

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for BHA (Butylated Hydroxyanisole) across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
cancer slope factor =0.0002 (mg/kg-day)-1 Human inhalation chronic Cal OEHHA
cancer slope factor =0.0002 (mg/kg-day)-1 Human oral chronic Cal OEHHA
NOAEL =100 mg/kg-day Rat oral - EFSA
NOAEL =100 mg/kg-day Rat oral - EFSA
NOAEL =100 mg/kg-day Rat oral - EFSA
LOEL =500 mg/kg-day Mouse oral acute ECOTOX
NOEL =100 mg/kg-day Mouse oral acute ECOTOX
LOEL =2 % Rat oral subchronic ECOTOX
NOEL =2 % Rat oral subchronic ECOTOX
LOEL =2 % Rat oral subchronic ECOTOX

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
2B
Volume
40, Sup 7
Evaluation Year
1987

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα, ERβ, AR
LOEC: 10 µM
EU status: under_review (EU priority list 2019 Group B; SCCS requested)

mixed agonist/antagonist (ER); antagonist (AR, weak)

Dose-Response Data Points
Endpoint Target Value Direction
EC_testicular reproductive 100 µM — abnormal testicular formation (mice) µM agonist
SIN List ED: Endocrine Disruptor Cosmetic relevance: direct

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
CN restricted 0.5 All cosmetics (antioxidant use)
AU restricted - antioxidants

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (3 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_in_vitro 2.68 In vitro; human skin; 16h continuous Human skin in vitro SCCS/0306 BHA opinion; CIR 2024 (2024)
default 50.0 method=default - -
measured 0.07 method=measured - -

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Antioxidant Biocide Deodorizer Filler Flavouring and nutrient Food preservative Fragrance Oxidizing agent
Regulatory List Membership (3)
California Proposition 65 (OEHHA) IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for BHA (Butylated Hydroxyanisole).

Regulatory Flags

prop65 ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to BHA (Butylated Hydroxyanisole) by CAS number or substance name.

Studies
56
Lowest NOAEL
0.0029
Highest NOAEL
974

Units vary across source rows: mg/kg bw/day, mg/kg/d, mg/kg bw/d

COSMOS_DB CIR_vision_codex SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
2.68 In vitro; human skin; 16h continuous 0.07% BHA solution
50.0 method=default -
0.07 method=measured -

Known Synonyms

(1,1-Dimethylethyl)-4-methoxyphenol 1,1-(Dimethylethyl)-4-methoxyphenol Phenol, tert-butyl-4-methoxy- terc-butil-4-metoxifenol tert-Butyl-4-hydroxyanisole tert-Butyl-4-methoxyphenol Phenol, (1,1-dimethylethyl)-4-methoxy- BHA Tenox BHA Anisole, butylated hydroxy- Antrancine 12 Butyl hydroxyanisole t-Butyl hydroxyanisole EEC No. E320 EINECS 246-563-8 FEMA No. 2183 Nepantiox 1-F Nipantiox 1-F Sustane 1-F 2-terc.Butyl-4-methoxyfenol

Chemical Function

Antioxidant Deodorizer Fragrance Biocide Flavouring and nutrient Filler Food preservative

Regulatory Lists

drinking_water; Europe; manufacturing; plastic_additive active_ingredient; Europe; Pesticides Europe consumer_product; Europe Europe; Raw materials inert_ingredient; non_food_use; Pesticides OEHHA Proposition 65 (3/2019) IFRA Transparency detected; drinking_water; MN Chemical Screening detected; drinking_water; MN Chemical Screening detected; drinking_water; MN Chemical Screening food_additive; Substances Added to Food (formerly EAFUS) (2/2019) children OEHHA Proposition 65 (1/2023) children; WA Children's Safe Product Act (4/2020) children children Europe; pharmaceutical

Australian Status

AICIS status: listed

Frequently Asked Questions

Is BHA (Butylated Hydroxyanisole) safe in cosmetics?

BHA (Butylated Hydroxyanisole) has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 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 NOAEL for BHA (Butylated Hydroxyanisole)?

The NOAEL (No Observed Adverse Effect Level) for BHA (Butylated Hydroxyanisole) is =220 mg/kg/d based on a reproductive toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.

Is BHA (Butylated Hydroxyanisole) used outside cosmetics?

BHA (Butylated Hydroxyanisole) also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does BHA (Butylated Hydroxyanisole) have different safety status in cosmetics vs industrial chemicals?

BHA (Butylated Hydroxyanisole) is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335, H351, H361, H361f, H411).

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