POTASSIUM FLUOROSILICATE

US FDA substance register · UNII 2610W49XYD · registered name POTASSIUM HEXAFLUOROSILICATE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Restricted

Taiwan · United Kingdom

Source: ASEAN Cosmetic Directive · EU Cosmetics Regulation · MFDS (Korea) cosmetic regulatory information · Taiwan FDA cosmetic ingredients · Taiwan FDA cosmetic regulations · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Field of application and/or use : (a) Toothpastes (b) Mouthwashes
• Maximum concentration permitted at final product : 0.15% expressed as fluorine. When it is mixed with other fluorine compounds permitted, the maximum concentration fluoride total must not exceed 0.15%
• Use conditions and warnings that must appear on the label : a) - Contains potassium fluorsilicate. For toothpaste containing 0.1% -0.15% fluoride, except if is already included that is contraindicated for children (e.g. “for adult use only”) it must contain the following warning: “Children under 6 years: Use an amount like a pea size, with adult supervision during brushing to minimize swallowing. If you ingest fluoride from other sources, consult your doctor or dentist" b) - Contains potassium fluorsilicate. - Keep out of children reach. - Do not use in children under 6 years old.

ASEAN

• Field of application and/or use : Oral hygiene products
• Maximum authorised concentration in the finished cosmetic product : 0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%.
• Other limitations and requirements : Thailand only 0.11% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.11%.
• Conditions of use and warning which must be printed on the labels : • Contains potassium fluorosilicate • Children of 6 years and under: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor(12)

European Union

• 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 potassium fluorosilicate For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.1'5.0% 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."

Korea’s toxic-substance GHS classification: Danger · H318 (category 1) · H332 (category 4) · H301 (category 3)

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex III (restricted substances), entry 41 · 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 % · applies to Oral products

Source: EU restricted substances (Annex III)

Restriction III/41

Source: EU CosIng ingredient list