# FERRIC OXIDE RED

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid0029632
Categories: beauty, cleaning, food, industrial, pharma
Functions: Colorant, Colour, Food additive, colour, Colourant
Identifier: DTXSID0029632

> FERRIC OXIDE RED: Used in cosmetics as a colourant. CI 77015 is classed chemically as an inorganic colour. It consists of aluminum silicate coloured with ferric oxide. Greenveil chemical-concern score: 60/100 — High concern based on regulatory listings.. Compiled from 10 published data sources.

## Safety assessment

- Chemical concern score: 60/100 — High concern based on regulatory listings.
- Confidence in this assessment: High
- Is it a concern? High concern: no hazard classifications on record. It is listed for cosmetic use in the EU.
- Rationale: Iron oxide is listed in Annex IV of the EU Cosmetics Regulation (EC) 1223/2009 (colorants allowed in cosmetic products).

## Regulatory status

- EU: Active — CI 77015 is classed chemically as an inorganic colour. It consists of aluminum silicate coloured with ferric oxide and conforms to the formula: Restriction: IV/121
- EU: Active — CI 77491 is classed chemically as an inorganic colour. It consists chiefly of ferric oxide that conforms to the formula: Restriction: IV/135
- EU: Active — CI 77492 is classed chemically as an inorganic colour. It consists chiefly of hydrated ferrous oxide that conforms to the formula: Restriction: IV/136
- EU: Active — CI 77499 is classed chemically as an inorganic colour. It consists chiefly of ferrous-ferric oxide (see also INCI:Iron Oxides) Restriction: IV/137
- EU: Active — Cosmetics Regulation annex IV / ref 137.
- EU: Active — Cosmetics Regulation annex IV / ref 136.
- EU: Active — Cosmetics Regulation annex IV / ref 135.
- EU: Active — Cosmetics Regulation annex IV / ref 134.
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products.
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Conditions of use and warnings: Purity criteria as set out in Commission Directive 95/45/EC (E172)
- EU: EFSA opinion — Safety and efficacy of iron compounds (E1) as feed additives for all species: ferric oxide based on a dossier submitted by Poortershaven Industriele Mineralen B.V (EFSA FEEDAP)
- GLOBAL: 0-0.5 mg/kg bw — JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: food additive, colour.
- GLOBAL: 0-0.5 mg/kg bw — JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: colour.
- US: commercial use observed — EPA CPDat observed this chemical in 3837 composition records across product categories including Construction and building materials, Furniture and furnishings, Cleaning products and household care. EPA CPDat classifies this chemical for functional uses including Dye, Pigment, Binder.
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 14 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 5 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: DROPS; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION, EXTENDED RELEASE; Potency: 2.7 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Potency: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Maximum daily exposure: 37 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 7 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED, EXTENDED RELEASE; Potency: 3.6 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; Potency: 0.15 mg
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: 1 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Potency: NA
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: NA
- US: marketed drug occurrence — FDA NDC lists this ingredient in 66 active drug products and 69 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.
- US: inactive ingredient database — Route: BUCCAL; Dosage form: TABLET; Potency: 0.4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED; Potency: 0.12 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 5 mg

## 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 iron compounds (E1) as feed additives for all species: ferric oxide based on a dossier submitted by Poortershaven Industriele Mineralen B.V (EFSA FEEDAP) — 2016 — https://doi.org/10.2903/j.efsa.2016.4508.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives): JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: food additive, colour. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/949; JECFA evaluation lists ADI 0-0.5 mg/kg bw. Functional class: colour. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/947.

## Data sources

- CosIng (updated 2026-09-23): https://ec.europa.eu/growth/tools-databases/cosing/details/30542
- EU CosIng Cosmetics Regulation Annexes (updated 2020-08-14): https://ec.europa.eu/growth/tools-databases/cosing/reference/annexes/list/IV
- EFSA OpenFoodTox (updated 2026-10-04): https://doi.org/10.5281/zenodo.8120114
- EPA Chemical and Products Database (updated september 25, 2015): https://living-future.org/declare-products/ab-pure/
- 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 National Drug Code Directory (updated 2028-07-31): https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory-support-files
- 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/4080
- openFDA Substance (updated 2026-05-24): https://api.fda.gov/other/substance.json?search=unii:1K09F3G675

_Assessed by Greenveil._