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.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
BHA (Butylated Hydroxyanisole) is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335, H351, H361, H361f, H411).
US NotesPermitted; 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).
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (oral)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (dermal)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 100 mg/kg bw/d (oral)
sccsSCCS/1682/25unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (not specified)
sccsSCCS/1682/25unknown
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)
SIN List ED: Endocrine DisruptorCosmetic 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
AntioxidantBiocideDeodorizerFillerFlavouring and nutrientFood preservativeFragranceOxidizing agent
Regulatory List Membership (3)
California Proposition 65 (OEHHA)IFRA Fragrance Transparency ListFDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for BHA (Butylated Hydroxyanisole).
AntioxidantDeodorizerFragranceBiocideFlavouring and nutrientFillerFood preservative
Regulatory Lists
drinking_water; Europe; manufacturing; plastic_additiveactive_ingredient; Europe; PesticidesEuropeconsumer_product; EuropeEurope; Raw materialsinert_ingredient; non_food_use; PesticidesOEHHA Proposition 65 (3/2019)IFRA Transparencydetected; drinking_water; MN Chemical Screeningdetected; drinking_water; MN Chemical Screeningdetected; drinking_water; MN Chemical Screeningfood_additive; Substances Added to Food (formerly EAFUS) (2/2019)childrenOEHHA Proposition 65 (1/2023)children; WA Children's Safe Product Act (4/2020)childrenchildrenEurope; 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).
Compliance Tools
Check BHA (Butylated Hydroxyanisole) compliance across multiple jurisdictions:
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