我国化妆品原料安全信息库的建立及其应用展望

doi:10.3969/j.issn.1001-1803.2022.11.011

摘要/Abstract

摘要：

在新修订的《化妆品监督管理条例》背景下，国家药监局构建了全新的化妆品法规和技术体系，加强了化妆品原料管理和安全评估，并提出化妆品原料安全信息报送相关要求。中检院结合法规要求和监管实际需求，围绕化妆品原料的精细化管理开展一系列相关研究，包括原料分类和关键特征、原料基本信息、原料鉴别和特征性指标、风险信息和控制指标、安全信息使用等，并据此建设“化妆品原料安全信息登记平台”，用于化妆品原料安全信息的规范化填报和管理。通过对化妆品原料安全信息的收集、利用和分析，同时对化妆品法规标准相关数据库不断研究整合，将在我国逐步构建起科学高效的“化妆品原料安全信息库”，在化妆品技术监管工作中提供有力的大数据支撑，不断提高我国的化妆品监管和安全性评价水平。

关键词: 化妆品, 原料安全信息, 数据库, 安全评估, 监管

Abstract:

With the newly revised Regulations on the Supervision and Administration of Cosmetics, the National Medical Products Administration （NMPA） has established new regulations and an improved technical system for cosmetics. NMPA has strengthened ingredient management and safety assessment of cosmetics. NMPA has put forward the requirements for submission of the safety information of cosmetic ingredients. On the basis of relevant regulations and practical needs in supervision, the National Institutes for Food and Drug Control （NIFDC） has studied ingredient management, including classification, key features and basic information of ingredients, identification, characteristic indexes, risk information and control, and use of safety information, and accordingly, NIFDC has built a “cosmetic ingredient information platform” for the submission and management of such safety information. In future, with collecting, utilizing, and analyzing of the safety information of cosmetic ingredients, as well as with integrating those databases related to cosmetic regulations and technical standards, NMPA and NIFDC will build a scientific and efficient “database for safety information on cosmetic ingredients” in China, which will provide strong big-data support in technical work and will continuously improve the supervision and safety evaluation for cosmetics.

Key words: cosmetics, ingredient safety information, database, safety evaluation, supervision

中图分类号:

TQ658

苏哲,胡康,王钢力,路勇. 我国化妆品原料安全信息库的建立及其应用展望[J]. 日用化学工业（中英文）, 2022, 52(11): 1221-1228.

Su Zhe,Hu Kang,Wang Gangli,Lu Yong. Establishment and prospects of the database for safety information on cosmetic ingredients in China[J]. China Surfactant Detergent & Cosmetics, 2022, 52(11): 1221-1228.

图/表 3

表 1

表 2

化妆品原料常见风险物质"

风险物质	常见情形举例
重金属	在《化妆品安全技术规范》中，对终产品中的汞、铅、砷、镉设定了限值要求；在其他国家或地区的化妆品法规中，也会关注其他重金属，如铬、镍、硒、铍、锑、锶、锆、钴等
微生物	在《化妆品安全技术规范》中，对终产品中的菌落总数、霉菌和酵母菌总数、耐热大肠菌群、金黄色葡萄球菌、铜绿假单胞菌设定了限值要求
农药残留	对于直接来源于植物、未经精制的原料，一般需考虑是否存在农药残留风险，如直接压榨获得的橄榄油等
甲醇	常见需考虑是否存在甲醇风险的原料如乙醇、异丙醇等
二噁烷	含有乙氧基结构的原料一般需考虑是否存在二噁烷风险，如PEG-10聚二甲基硅氧烷、鲸蜡醇聚醚-7、聚山梨醇酯-20等
石棉	一般需考虑是否存在石棉风险的原料如滑石粉等
甲醛	甲醛缓释体类原料一般需考虑是否存在甲醛风险，如双（羟甲基）咪唑烷基脲、DMDM乙内酰脲等
二甘醇	常见需考虑是否存在二甘醇风险的原料如甘油、1，3-丙二醇、PEG-10聚二甲基硅氧烷、鲸蜡醇聚醚-7、聚山梨醇酯-20等
苯酚	常见需考虑是否存在苯酚风险的原料如苯氧乙醇等
丙烯酰胺	在《化妆品安全技术规范》中，“聚丙烯酰胺类”被收录为限用组分，用于驻留类体用产品时产品中丙烯酰胺单体的最大残留量为0.1 mg/kg，用于其他产品时产品中丙烯酰胺单体最大残留量为0.5 mg/kg。常见需考虑是否存在丙烯酰胺风险的原料如丙烯酸（酯）类/丙烯酰胺共聚物、丙烯酰二甲基牛磺酸钠/丙烯酰胺/VP共聚物、聚季铵盐-7等
仲链烷胺、亚硝胺	在《化妆品安全技术规范》中，对部分原料中的仲链烷胺、亚硝胺作出限制要求，一般需考虑相关风险，如：三链烷胺、三链烷醇胺及它们的盐类；脂肪酸双链烷酰胺及脂肪酸双链烷醇酰胺；单链烷胺、单链烷醇胺及它们的盐类
1，3-丁二烯	常见需考虑是否存在1，3-丁二烯风险的原料如丙烷、丁烷等
氢醌	常见需考虑是否存在氢醌风险的原料如熊果苷等
苯	常见需考虑是否存在苯风险的原料如卡波姆等

表 2

图 1

参考文献 15

[1]	Su Zhe, Luo Feiya, Pei Xinrong, et al. Final publication of the “Regulations on the Supervision and Administration of Cosmetics” and new prospectives of cosmetic science in China[J]. Cosmetics, 2020, 7 (4) : 98. doi: 10.3390/cosmetics7040098
[2]	Su Zhe, Lv Bingfeng, Zhang Fenglan, et al. Talking about the construction of cosmetics supervision information and the prospect of wisdom review[J]. Flavour Fragrance Cosmetics, 2021 (2) : 109-114.
[3]	National Medical Products Administration. An online notification for the information platform for cosmetics registration and filing[EB/OL]. (2021-03-23)[2021-09-24]. https://www.nmpa.gov.cn/yaowen/ypjgyw/20210323092508104.html.
[4]	Lu Yong, Wang Gangli, Su Zhe. Start of intelligent submission and evaluation for cosmetics[N]. China Pharmaceutical News, 2021-05-11 (005).
[5]	Su Zhe, Hu Kang, Lv Bingfeng, et al. Technical key points of intelligent evaluation for cosmetics in China[J]. China Surfactant Detergent & Cosmetics, 2022, 52 (10) : 1113-1120.
[6]	National Medical Products Administration. Announcement on promulgation of the Inventory of Existing Cosmetic Ingredients in China (2021 version) [EB/OL]. (2021-04-30)[2021-12-10]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210430162707173.html.
[7]	National Medical Products Administration. Announcement on updating the List of Substances Prohibited in Cosmetic Products[EB/OL]. (2021-05-28)[2021-12-10].
[8]	National Medical Products Administration. Announcement on promulgation of the Notes of Guidance for Cosmetic Safety Evaluation[EB/OL]. (2021-04-09)[2021-11-30]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210409160436155.html.
[9]	National Medical Products Administration. Announcement on promulgation of the Documentary Requirements for Registration or Filing of Cosmetics[EB/OL]. (2021-03-04)[2021-12-10]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210304140747119.html.
[10]	National Medical Products Administration. FAQs on cosmetics supervision and management[EB/OL]. (2019-01-10)[2021-12-21]. https://www.nmpa.gov.cn/hzhp/hzhpfgwj/hzhpgzwj/20190110093701592.html.
[11]	Su Zhe, Luo Feiya, Zhang Fenglan, et al. On worldwide supervision and latest research progress about cosmetic nanomaterials[J]. Chinese Pharmaceutical Affaris, 2021, 35 (2) : 227-236.
[12]	Su Zhe, Li Lin, Hu Kang, et al. A classification study on peptide and protein ingredients used in cosmetics and discussion of intelligent supervision in the future[J]. Flavour Fragrance Cosmetics, 2022 (3) : 25-31, 43.
[13]	ICCR. Associations survey of nanomaterials used in cosmetic products[EB/OL]. (2011-06-03)[2022-02-24]. https://iccr-cosmetics.org.
[14]	Wu Jing, Zhang Fenglan, Xing Shuxia, et al. Quality analysis and supervision suggestion of freckle remover and whitening cosmetics[J]. Chin. J. Health Lab. Tec., 2016, 26 (16) : 2429-2432.
[15]	Wu Jing, Liu Min, Xing Shuxia, et al. Quality and safety analysis of hair dyeing cosmetics during 2018 to 2019[J]. Flavour Fragrance Cosmetics, 2021 (1) : 65-68, 72.