China Surfactant Detergent & Cosmetics ›› 2026, Vol. 56 ›› Issue (10): 1380-1391.doi: 10.3969/j.issn.2097-2806.2026.10.011
• Reviews • Previous Articles Next Articles
Mengxin Feng,Cong Wang,Lingli Wang,Fenglan Zhang,Dandan Liu,Zhenxi Yu*(
),Qingli Wang*(
)
Received:2025-12-14
Revised:2026-09-22
Online:2026-10-22
Published:2026-10-30
Contact:
E-mail: CLC Number:
Mengxin Feng, Cong Wang, Lingli Wang, Fenglan Zhang, Dandan Liu, Zhenxi Yu, Qingli Wang. Research on domestic and foreign regulatory systems for freckle-removing and skin-whitening cosmetics from the perspective of regulatory science[J].China Surfactant Detergent & Cosmetics, 2026, 56(10): 1380-1391.
Tab.1
Selected ingredients in the restricted use list of cosmetic ingredients of the Taiwan region of China"
| 序号 | 中文名称 | 英文名称 | INCI名称 | CAS号 | 限量标准 |
|---|---|---|---|---|---|
| 1 | 抗坏血酸磷酸酯镁 | Ascorbic acid, monoester with phosphoric acid, magnesium salt (2:3) | Magnesium ascorbyl phosphate | 114040-31-2/ 113170-55-1 | 3% |
| 2 | 曲酸 | 5-Hydroxy-2-hydroxymethyl-4-pyrone | Kojic acid | 501-30-4 | 2% |
| 3 | 抗坏血酸葡糖苷 | 2-O-alpha-D-Glucopyranosyl-L-ascorbic acid | Ascorbyl glucoside | 129499-78-1 | 2% |
| 4 | 熊果苷 | 4-Hydroxyphenyl-beta-D-glucopyranoside | Arbutin | 497-76-7 | 7%,产品中的杂质(对苯二酚)应在20 ppm以下 |
| 5 | 抗坏血酸磷酸酯钠 | Sodium ascorbyl phosphate | Sodium ascorbyl phosphate | 66170-10-3 | 3% |
| 6 | 鞣花酸 | 2, 3, 7, 8-Tetrahydroxy- [1] -benzopyrano [5, 4, 3, -cde] - [1] -benzopyran-5, 10-dione | Ellagic acid | 476-66-4 | 0.5% |
| 7 | 洋甘菊提取物 | Chamomile ET | 0.5% | ||
| 8 | 3-O-乙基抗坏血酸 | 3-O-Ethyl ascorbic acid | 3-O-Ethyl ascorbic acid | 86404-04-8 | 2% |
| 9 | 凝血酸 | Cyclohexanecarboxylic acid, 4- (aminomethyl) -, trans- | Tranexamic acid | 1197-18-8 | 3% |
| 10 | 甲氧基水杨酸钾 | Benzoic acid, 2-hydroxy-4-methoxy-, monopotassium salt | Potassium methoxysalicylate | 152312-71-5 | 3% |
| 11 | 四氢木兰醇 | 5, 5'-Dipropyl-biphenyl-2, 2'-diol | Tetrahydromagnolol | 20601-85-8 | 0.5% |
| 12 | 凝血酸十六烷基酯盐酸盐 | Cyclohexanecarboxylic acid, 4- (Aminomethyl) -, hexadecyl ester, hydrochloride, trans- | Cetyl tranexamate HCl | 913541-96-5 | 3% |
| 13 | 四己基癸醇抗坏血酸酯 | Ascorbyl tetraisopalmitate | Ascorbyl tetraisopalmitate | 3.0% |
Tab.2
Requirements for selected ingredients in Annex III of EU Regulation (EC) No 1223/2009"
| 序号 | 中文 名称 | 化学名称/INN | 常见成分术语表名称 | CAS号 | 限用要求 | ||
|---|---|---|---|---|---|---|---|
| 产品类型,身体使用部分 | 产品中最大使用浓度 | 其他 | |||||
| 1 | 曲酸 | 5-Hydroxy-2- (hydroxymethyl) -4H-pyrane-4-one | Kojic acid | 501-30-4 | 面部和手部 | 1% | |
| 2 | α-熊果苷 | 4-Hydroxyphenyl-alpha-D- glucopyranoside | Alpha-arbutin | 84380-01-8 | a. 面霜; b. 身体乳 | a. 2%; b. 0.5% | 含有α-熊果苷的配方中,氢醌的含量应尽可能低,且不得高于不可避免存在的痕量浓度 |
| 3 | 熊果苷 | 4-Hydroxyphenyl-beta-D- glucopyranoside | Arbutin | 497-76-7 | 面霜 | 7% | 含有熊果苷的配方中,氢醌的含量应尽可能低,且不得高于不可避免存在的痕量浓度 |
Tab.3
Product ingredients and concentrations contributing to skin whitening in the Republic of Korea"
| 序号 | 中文名称 | 英文名称 | 有效浓度/含量 |
|---|---|---|---|
| 1 | 小构树根提取物1) | Broussonetia extract | 2% |
| 2 | 熊果苷 | Arbutin | 2%~5% |
| 3 | 3-O-乙基抗坏血酸 | Ethyl ascorbyl ether/3-O-ethyl ascorbate | 1%~2% |
| 4 | 油溶性甘草提取物2) | Oil soluble licorice (Glycyrrhiza) extract | 0.05% |
| 5 | 抗坏血酸葡糖苷 | Ascobyl glucoside | 2% |
| 6 | 抗坏血酸磷酸酯镁 | 3% | |
| 7 | 烟酰胺 | Niacinamide | 2%~5% |
| 8 | α-红没药醇 | Alpha-bisabolol | 0.5% |
| 9 | 抗坏血酸四异棕榈酸酯 | Ascorbyl tetraisopalmitate | 2% |
Tab.4
Summary of the global regulatory status of freckle-removing and skin-whitening cosmetics"
| 监管状况 | 我国 | 欧盟 | 美国 | 日本 | 韩国 | 加拿大 | ||
|---|---|---|---|---|---|---|---|---|
| 我国大陆 | 我国台湾地区 | |||||||
| 产品归属 | 特殊化妆品 | 化妆品 | 化妆品或药品 | 化妆品或药品 | 医药部外品 | 机能性化妆品 | 健康产品或药品 | |
| 祛斑美白产品相关释义 | 有助于减轻或减缓皮肤色素沉着达到皮肤美白增白效果;通过物理遮盖形式达到皮肤美白增白效果(注:含改善因色素沉着导致痘印的产品) | 用来淡化皮肤色素沉着(颜色)的产品 | 抑制黑色素的生成,防止斑点、雀斑 | 防止黑色素在皮肤上沉淀,抑制斑点、雀斑等的产生或淡化沉淀到皮肤上的黑色素颜色,有助于美白肌肤的化妆品 | ||||
| 祛斑美白功效宣称注意事项 | 不得使用医疗术语或者暗示产品具有医疗作用;不得使用虚假、夸大、绝对化词语;等 | 无明确要求 | 化妆品禁止宣称:治疗色素异常问题(如黄褐斑、雀斑和老年斑) | 化妆品禁止宣称:治疗、缓解、减轻或预防疾病,或影响人体结构或功能 | 不认可宣称:表达皮肤原本的颜色发生变化(如变白);消除已经形成的色斑和雀斑(治疗性);与批准功效无关的关于色斑、色素沉着等的表述,如顽固色斑和老年斑的美白,适用于痘印、炎症后色素沉着的暗沉,预防痘痘留下的色素沉着;暗示改善肌肤质地的表述 | 无明确要求 | 对于“消除老年斑、防止新斑点出现、防止老年斑的出现/显现及任何关于皮肤脱色的暗示或宣称”等治疗作用或健康相关声明,需授权方可宣称 | |
| 产品管理模式 | 审批制 | 产品登录制度 | 化妆品:备案制;药品:审批制 | 化妆品:强制性登记;OTC药品:OTC专论系统;新药:审批制 | 审批制 | 审批制 | 审批制 | |
| 祛斑美白原料管理模式 | 新原料:注册制;已使用原料:与产品一同申报 | 祛斑美白功能新原料:审批制(随使用新原料的产品一同申报审批) | 发布美白化妆品功效原料清单 | |||||
| 功效管理 | 功效评价方式 | 人体功效评价试验 | 人体功效试验、体外功效试验 | 人体功效评价试验 | 试验研究 | |||
| 依据 | 《化妆品功效宣称评价规范》 | 《化妆品功效评价指南》《关于皮肤颜色的评估指南》 | 《为获得新功效的医药部外品美白功能评价试验指南》 | 《机能性化妆品有效性评价指南I:证明皮肤美白产品有效性或及美白功能的资料》 | ||||
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