# FUMARIC ACID

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid3021518
Categories: beauty, cleaning, food, industrial, pharma
Functions: Buffering, Flavouring agent, acidity regulator, Preservative, pH adjuster, Fragrance, Flavouring
Identifier: DTXSID3021518

> FUMARIC ACID: Used in cosmetics as a pH buffer. Greenveil chemical-concern score: 40/100 — Moderate concern based on regulatory listings.. Compiled from 10 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 82 composition records across product categories including Laboratory supplies, Cleaning and safety, Personal care.

## Regulatory status

- EU: Active — Listed in CosIng inventory for cosmetic use.
- EU: EFSA opinion — Scientific Opinion on the safety and efficacy of fumaric acid as a feed additive for all animal species (EFSA FEEDAP)
- EU: EFSA opinion — Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species (EFSA FEEDAP)
- GLOBAL: Evaluated — JECFA evaluation record.
- GLOBAL: NOT SPECIFIED (1989) — JECFA evaluation lists ADI NOT SPECIFIED (1989). Functional class: flavouring agent, acidity regulator.
- US: commercial use observed — EPA CPDat observed this chemical in 82 composition records across product categories including Laboratory supplies, Cleaning and safety, Personal care. EPA CPDat classifies this chemical for functional uses including Dispersing agent, pH regulating agent, Fragrance.
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 115 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Maximum daily exposure: 120 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 84 mg
- US: marketed drug occurrence — FDA NDC lists this ingredient in 44 active drug products and 48 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SOLUTION; Potency: 2 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 240 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SYRUP; Potency: 0.75 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 120 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): Scientific Opinion on the safety and efficacy of fumaric acid as a feed additive for all animal species (EFSA FEEDAP) — 2013 — https://doi.org/10.2903/j.efsa.2013.3102; Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species (EFSA FEEDAP) — 2012 — https://doi.org/10.2903/j.efsa.2012.2928.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives): JECFA evaluation record. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/109; JECFA evaluation lists ADI NOT SPECIFIED (1989). Functional class: flavouring agent, acidity regulator. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1723.

## Data sources

- CosIng (updated 2026-09-23): https://ec.europa.eu/growth/tools-databases/cosing/details/33964
- EFSA OpenFoodTox (updated 2026-10-04): https://doi.org/10.5281/zenodo.8120114
- EPA Chemical and Products Database (updated November 2014): http://siri.org/msds/f2/bhc/bhcsv.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 National Drug Code Directory (updated 2029-05-29): 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/109
- openFDA Substance (updated 2026-05-24): https://api.fda.gov/other/substance.json?search=unii:88XHZ13131
- PubChem Live Enrichment (updated 2026-05-17): https://pubchem.ncbi.nlm.nih.gov/compound/444972

_Assessed by Greenveil._