Is Ammonium Fluoride safe in cosmetics?
Ammonium Fluoride has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted.
Ammonium Fluoride
Also known as: Ammonium fluoride ((NH4)F), EINECS 235-185-9, Ammonium fluorure, Fluorek amonowy, UNII-4QT928IM0A (+2 more)
INCI: AMMONIUM FLUORIDE
Ammonium Fluoride (CAS 12125-01-8) is a cosmetic cosmetic ingredient functioning as Antiplaque agent; oral care (supports enamel remineralization). NOAEL 1695.7 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.15%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 12125-01-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Ammonium Fluoride is classified GHS Danger (H301, H311, H314, H318, H331) in the chemicals database but is restricted in EU cosmetics at max 0.15%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antiplaque agent; oral care (supports enamel remineralization)
Safety Rating
MODERATE
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.15%
US US Status
permitted
US Notes
Permitted — FDA regulates fluoride as OTC anticaries drug ingredient (21 CFR 355)
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ammonium Fluoride.
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. Corrosive on ingestion.
Long-term Exposure Effects
The substance may have effects on the bones and teeth. This may result in fluorosis.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Ammonium Fluoride across SCCS product categories, with measured dermal absorption where available.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Acute Toxicity
Hazard Class and Category
Acute Tox. 3 *; Acute Tox. 3 *; Acute Tox. 3 *
Hazard Statements
- H331 Toxic if inhaled
- H311 Toxic in contact with skin
- H301 Toxic if swallowed
Inserted via ATP: CLP00
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
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.
SA Saudi SFDA (III - Restricted)
Product type: Oral products. Max: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %.
BRIN Brazil/India Cosmetics
India: Restricted · max 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Pharmaceutical
Regulatory List Membership (1)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Ammonium Fluoride.
Regulatory Flags
eu_cosing_listed
Known Synonyms
Ammonium fluoride ((NH4)F)
EINECS 235-185-9
Ammonium fluorure
Fluorek amonowy
UNII-4QT928IM0A
Fluoruro amonico
NH4F
Chemical Function
Pharmaceutical
Regulatory Lists
Europe; Personal care; restricted
Australian Status
AICIS status: listed
Frequently Asked Questions
Is Ammonium Fluoride allowed in the EU?
Ammonium Fluoride EU regulatory status: restricted. Maximum allowed concentration: 0.15%. This is based on EU Regulation 1223/2009 and its amendments.
What does Ammonium Fluoride do in cosmetics?
Ammonium Fluoride functions as: Antiplaque agent; oral care (supports enamel remineralization). It is classified as a cosmetic ingredient in our database. CAS number: 12125-01-8.
Is Ammonium Fluoride used outside cosmetics?
Ammonium Fluoride also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Ammonium Fluoride have different safety status in cosmetics vs industrial chemicals?
Ammonium Fluoride is classified GHS Danger (H301, H311, H314, H318, H331) in the chemicals database but is restricted in EU cosmetics at max 0.15%.
Compliance Tools
Check Ammonium Fluoride 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
Compare limits across jurisdictions
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