CETYLAMINE HYDROFLUORIDE

米国FDA 物質登録 · UNII S58EH61Q1Y · 登録名 HETAFLUR · 単一の化学物質

出典: 米国FDA 物質識別番号（UNII）

制限

イギリス

出典: ASEAN 化粧品指令 · EU 化粧品規則 · 韓国食薬処 化粧品規制情報 · 台湾FDA 化粧品成分 · 台湾FDA 化粧品規制 · 英国 化粧品規則

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)

台湾

• ※ 染髮產品之限量標準：係指該成分依產品使用說明書混合後之最高允許使用量。
• ※ 化粧品之外包裝或容器，應明顯標示本表所列成分之注意事項。因外包裝或容器表面積過小或其他特殊情形致不能標示者，應於標籤、仿單或以其他方式刊載之。
• ※ 本表所稱之口腔製劑，包含非藥用牙膏、漱口水類及美白牙齒類等化粧品。
• ※ 化粧品宣稱效能者，須符合化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則規定。
• 用途 : 使用限制
• 最大配合量 : 口腔製劑 : 0.15%(以 F 計)
• 倘混合使用其他我國準用之氟化合物，其氟總量不得超過0.15%。
• 2. 非藥用牙膏含氟化合物者， 應刊載其氟含量。

欧州連合

• 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化粧品規則 附属書III（制限物質） 第36項 · 最大濃度 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % · 適用 Oral products

出典: EU 制限成分（附属書III）

Restriction III/36

出典: EU CosIng 成分リスト