# BUTYLATED HYDROXYANISOLE

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid7020215
Categories: beauty, cleaning, food, industrial, pharma
Functions: Antioxidant, Fragrance, Preservative, Flavouring, Deodorant, Antimicrobial
Identifier: DTXSID7020215

> BUTYLATED HYDROXYANISOLE: Used in cosmetics as an antioxidant and a fragrance ingredient. Greenveil chemical-concern score: 40/100 — Moderate concern based on regulatory listings.. Compiled from 9 published data sources.

## Safety assessment

- Chemical concern score: 40/100 — Moderate concern based on regulatory listings.
- Confidence in this assessment: High
- Is it a concern? Moderate concern: no hazard classifications on record. It is listed for cosmetic use in the EU.
- Rationale: EPA CPDat observed this chemical in 298 composition records across product categories including Personal care, Laboratory supplies, Cleaning and safety.

## Regulatory status

- EU: Active — BHA is a mixture of isomers of tertiary butyl-substituted 4-methoxyphenols. It consists chiefly of 3-t-butyl-4-hydroxyanisole with lesser amounts of 2-t-butyl-4-hydroxyanisole. It conforms generally to the formula:
- EU: EFSA opinion — Safety and efficacy of a feed additive consisting of butylated hydroxyanisole (BHA) for use in cats (FEDIAF) (EFSA FEEDAP)
- EU: EFSA opinion — Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive (EFSA ANS)
- EU: EFSA statement — Statement on the safety assessment of the exposure to butylated ydroxyanisole E 320 (BHA) by applying a new exposure assessment methodology (EFSA ANS)
- EU: EFSA opinion — Safety and efficacy of butylated hydroxyanisole (BHA) as a feed additive for all animal species (EFSA FEEDAP)
- EU: EFSA opinion — Safety of butylated hydroxy anisole (BHA) for all animal species (EFSA FEEDAP)
- GLOBAL: Evaluated — JECFA evaluation record.
- GLOBAL: 0-0.5 mg/kg bw — JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: antioxidant.
- US: commercial use observed — EPA CPDat observed this chemical in 298 composition records across product categories including Personal care, Laboratory supplies, Cleaning and safety. EPA CPDat classifies this chemical for functional uses including Antioxidant, Deodorizer, Fragrance.
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 5 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Potency: 2.5 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 0.4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: RECTAL; Dosage form: SUPPOSITORY; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: FILM; Potency: 0.08 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Potency: 5.2 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Maximum daily exposure: 7 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: OINTMENT; Potency: 0.01 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: CREAM; Potency: 0.03 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: OINTMENT; Potency: 0.02 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: 1 mg
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as mixture.
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION; Potency: NA
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, FOR SOLUTION; Potency: NA
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: 0.08 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: GRANULE, FOR SUSPENSION; Potency: NA
- US: observed in branded food ingredient statements — Observed in 1 USDA branded foods including 1.75L Bloody Mary with Horseradish (MED).

## Expert safety opinions

- SCCS (EU Scientific Committee on Consumer Safety): no opinion on file.
- CIR (Cosmetic Ingredient Review (US expert panel)): no opinion on file.
- EFSA (European Food Safety Authority): Safety and efficacy of a feed additive consisting of butylated hydroxyanisole (BHA) for use in cats (FEDIAF) (EFSA FEEDAP) — 2021 — https://doi.org/10.2903/j.efsa.2021.6714; Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive (EFSA ANS) — 2011 — https://doi.org/10.2903/j.efsa.2011.2392; Statement on the safety assessment of the exposure to butylated ydroxyanisole E 320 (BHA) by applying a new exposure assessment methodology (EFSA ANS) — 2012 — https://doi.org/10.2903/j.efsa.2012.2759; Safety and efficacy of butylated hydroxyanisole (BHA) as a feed additive for all animal species (EFSA FEEDAP) — 2018 — https://doi.org/10.2903/j.efsa.2018.5215; Safety of butylated hydroxy anisole (BHA) for all animal species (EFSA FEEDAP) — 2019 — https://doi.org/10.2903/j.efsa.2019.5913.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives): JECFA evaluation record. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1910; JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: antioxidant. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2140.

## Data sources

- CosIng (updated 2026-09-23): https://ec.europa.eu/growth/tools-databases/cosing/details/32184
- EFSA OpenFoodTox (updated 2026-10-04): https://doi.org/10.5281/zenodo.8120114
- EPA Chemical and Products Database (updated mar 30 1989): http://siri.org/msds/f1/byk/bykns.html
- EPA DSSTox Identifiers (updated 2025-12-29): https://epa.figshare.com/articles/dataset/Chemistry_Dashboard_Data_DSSTox_Identifiers_Mapped_to_CAS_Numbers_and_Names/5588566
- FDA Inactive Ingredient Database (updated 2026-01-09): https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-database-download
- FDA GSRS UNII (updated 2026-02-26): https://precision.fda.gov/uniisearch/
- WHO JECFA Database (updated 2026-10-04): https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1910
- openFDA Substance (updated 2026-05-24): https://api.fda.gov/other/substance.json?search=unii:REK4960K2U
- USDA Branded Foods (updated 2026-02-19): https://fdc.nal.usda.gov/fdc-app.html#/food-details/2753336/details

_Assessed by Greenveil._