# SODIUM MONOFLUOROPHOSPHATE

URL: https://app.greenveil.ai/ingredients/ingredient_source_ref_annex_ref_iii_27
Categories: beauty, pharma
Functions: oral care, Oral Care Agent, Pharmaceutical
Identifier: DTXSID70872554

> SODIUM MONOFLUOROPHOSPHATE is used as oral care / oral care agent. Greenveil chemical-concern score: 70/100 — High concern based on regulatory listings.. Assessed from 7 sources.

## Safety assessment

- Chemical concern score: 70/100 — High concern based on regulatory listings.
- Confidence: 4
- Rationale: Sodium monofluorophosphate is restricted in cosmetic products under Annex III of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: restricted — Annex III of EU Cosmetics Regulation (EC) 1223/2009: substances which cosmetic products must not contain except subject to the restrictions laid down. Product types: Oral products Maximum concentration: 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15% Conditions of use and warnings: Contains sodium monofluorophosphate For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of…
- US: commercial use observed — EPA CPDat observed this chemical in 24 composition records across product categories including Personal care. EPA CPDat classifies this chemical for functional uses including Pharmaceutical, oral care, Oral Care Agent.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 158 active drug products and 162 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.

_Assessed by Greenveil._