Good Antioxidant NOAEL Data SCCS/CIR Reviewed

BHA

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 (+14 more)

BHA (CAS 25013-16-5) is a cosmetic antioxidant functioning as Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT. NOAEL 50 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.07%; 5 safety opinions reviewed (SCCS Opinion). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and food safety data.

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

Auto-generated CPSR Part A draft with source citations
CAS Number
25013-16-5
View industrial chemical safety profile →
Function
Antioxidant; synthetic chain-breaking free radical scavenger (SET/HAT mechanism); product preservative against oxidative degradation in oils and waxes
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
246-563-8
ChEBI: CHEBI:76359 UNII: REK4960K2U Wikidata: Q409401

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.07%
US 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 multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for BHA.

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 =220 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =220 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
NOAEL =420 mg/kg/d oral rat reproductive toxicity CIR Safety Assessment
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 Opinion SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (oral)
SCCS Opinion SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (dermal)
SCCS Opinion SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 100 mg/kg bw/d (oral)
SCCS Opinion SCCS/1682/25 unknown
Verdict: unknown
NOAEL: 50 mg/kg bw/d (not specified)
SCCS Opinion 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 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 - -

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category Typical Range Max Reported Source
Body Lotion 0.01–0.1 0.5 CIR Safety Assessment

Additional Ingredient Properties

1 property record from structured ingredient metadata.

baby_pediatric
{"cas_number": "CAS-FUNC-26", "ingredient_class": "other", "pediatric_safety_rating": "caution", "minimum_age_months": "12", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Synthetic antioxidant - scrutiny, limit babies", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_we…

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.

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

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to BHA by CAS number or substance name.

Studies
56
Lowest NOAEL
0.0029
Highest NOAEL
974

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

SCCS Opinion COSMOS DB CIR Safety Assessment

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- 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

Cross-Vertical Safety Context

Same-CAS public records found in food safety data.

SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Butylated hydroxyanisole
E Number
E320
ADI
0.5 mg/kg bw
Food Category
preservative
View full food safety profile →

Frequently Asked Questions

Is BHA safe in cosmetics?

BHA has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by SCCS Opinion.

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 NOAEL for BHA?

The NOAEL (No Observed Adverse Effect Level) for BHA 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 Safety Assessment.

Is BHA used outside cosmetics?

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

Does BHA have different safety status in cosmetics vs industrial chemicals?

BHA is classified GHS CMR hazard (H302, H315, H319, H335, H351, H361, H361f, H411) in the chemicals database but is restricted in EU cosmetics at max 0.07%.

Compliance Tools

Check BHA compliance across multiple jurisdictions:

Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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