CETYLAMINE HYDROFLUORIDE

US FDA substance register · UNII S58EH61Q1Y · registered name HETAFLUR · 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)

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 Hexadecyl ammonium fluoride • 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 Cetylamine hydrofluoride. 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.”

EU Cosmetics Regulation, Annex III (restricted substances), entry 36 · 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/36

Source: EU CosIng ingredient list