Is Ferric Ammonium Citrate safe in cosmetics?
Ferric Ammonium Citrate has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 1 toxicological study endpoint(s) are available in our database.
Ferric Ammonium Citrate
Also known as: FAC, 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, ammonium iron(3+) salt, Ammonium iron(III) citrate, Ammonium ferric citrate, Ammonium iron(3+) citrate (+11 more)
INCI: FERRIC AMMONIUM CITRATE
Ferric Ammonium Citrate (CAS 1185-57-5) is a cosmetic cosmetic ingredient functioning as Cosmetic colorant, Oral care agent. NOAEL 100 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 1185-57-5 →
Auto-generated CPSR Part A draft with source citations
Function
Cosmetic colorant, Oral care agent
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
azane;2-hydroxypropane-1,2,3-tricarboxylic acid;iron(3+)
InChIKey
FRHBOQMZUOWXQL-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted under 21 CFR 73.1025 (drug color additive) and 21 CFR 184.1296 (GRAS food); permanently listed, exempt from batch certification
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ferric Ammonium Citrate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
1 study endpoint found for Ferric Ammonium Citrate. 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 | =425 mg/kg bw/day | oral | Rabbit | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Ferric Ammonium Citrate across SCCS product categories, with measured dermal absorption where available.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
Inhalation of dust irritates nose and throat. Ingestion causes irritation of mouth and stomach. Dust irritates eyes and causes mild irritation of skin. | Inhalation of ferric salts as dusts and mists is irritating to the respiratory tract. Ferric salts are regarded as skin irritants. /Iron salts/ | If inhaled, iron is a local irritant to the lung and gastrointestinal tract. /Iron compounds/
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (1)
JECFA Evaluation
AMMONIUM FERRIC CITRATE | 1985 | Group PMTDI for iron, expressed as Fe | TRS 733-JECFA 29/25 | NOT PREPARED
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-caking agent
Dye
Flavouring and nutrient
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Ferric Ammonium Citrate.
Regulatory Flags
colorant
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Ferric Ammonium Citrate by CAS number or substance name.
Studies
19
Lowest NOAEL
100 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
ToxValDB_ECHA_IUCLID
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip
Known Synonyms
FAC
1,2,3-Propanetricarboxylic acid, 2-hydroxy-, ammonium iron(3+) salt
Ammonium iron(III) citrate
Ammonium ferric citrate
Ammonium iron(3+) citrate
Ammonium iron(3+) 2-hydroxy-1,2,3-propanetricarboxylate
EINECS 214-686-6
Ferric ammonium citrate, green
Iron ammonium citrate
Iron ammonium citrate, green
Iron(III) ammonium citrate
Ferri Seltz
Ammonii ferri citras
Ferri-ammoniumcitrat, braunes
Ferrum citricum ammoniatum fuscum
UNII-UVP74NG1C5
Chemical Function
Dye
Flavouring and nutrient
Anti-caking agent
Regulatory Lists
Medical/dental
Europe; supplements
Europe; food_additive; supplements
Europe
Canada; pharmaceutical
Canada; pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
11
Frequently Asked Questions
Is Ferric Ammonium Citrate allowed in the EU?
Ferric Ammonium Citrate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Ferric Ammonium Citrate do in cosmetics?
Ferric Ammonium Citrate functions as: Cosmetic colorant, Oral care agent. It is classified as a cosmetic ingredient in our database. CAS number: 1185-57-5.
What is the NOAEL for Ferric Ammonium Citrate?
The NOAEL (No Observed Adverse Effect Level) for Ferric Ammonium Citrate is =425 mg/kg bw/day based on a reproduction developmental study via oral route in Rabbit. Source: ToxValDB_ECHA_IUCLID.
Is Ferric Ammonium Citrate used outside cosmetics?
Ferric Ammonium Citrate also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Ferric Ammonium Citrate compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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