Sodium Monofluorophosphate(in 178 products)
Potential Risk Index®:
About:
Functions:
1. Antiseptic / Disinfectant - Prevents growth of unwanted microorganisms.
2. Drug / Medicine - Treats, alleviates, cures, or prevents sickness. As officially declared by a governmental drug/medicine regulatory body
A fluoride salt commonly found in toothpaste and oral care products.
Please see Sodium Fluoride for further information.
EU CosIng Annex III Restriction Information:
Regulation:
(EC) No 344/2013
Annex/Ref#:
III/27
Product Type, body parts:
Oral products
Maximum concentration in ready for use preparation:
0.15% calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Wording of 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 fluoride from other sources consult a dentist or doctor."
SCCS opinions:
0653/03 - Opinion concerning the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 years
0882/05 - Opinion on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years
1214/09 - Clarification on the Opinions SCCNFP/0653/03 and SCCP/0882/05 on the Safety of Fluorine Compounds in Oral Hygiene Products for Children under the Age of 6 Years
Scientific References:
1. PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/24266
Regulatory References:
1. CANADA INGREDIENT HOTLIST, List of Ingredients that are Restricted for Use in Cosmetic Products [2019]
- Fluoride containing substances
2. EU CosIng Annex III, SUBSTANCES WITH RESTRICTIONS IN COSMETIC PRODUCTS [2018]
- Ref: III/27
Safety and Hazards (UN GHS):
1. Harmful if swallowed (H302)
2. Harmful in contact with skin (H312)
3. Causes skin irritation (H315)
4. Causes serious eye irritation (H319)
5. Harmful if inhaled (H332)
6. May cause respiratory irritation (H335)
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