2022年度国家药品监督管理局通告不合格化妆品问题分析

Analysis on Problems of Unqualified Cosmetics Announced by NMPA in 2022

目的:统计分析2022年度国家化妆品监督抽检中发现的不合格情况,分析其原因及危害,为化妆品靶向监管提供参考。方法:收集整理国家药品监督管理局官网发布的2022年度国家化妆品监督抽检通告数据,对不合格产品的类别、产地、抽样地等信息进行汇总,分析问题产生原因,提出化妆品监管建议。结果:2022年度国家化妆品监督抽检通告不合格产品共计486批次,其中染发类、洗发护发类和防晒类不合格产品共计366批次(占比75.3%),不合格原因主要是检出与产品标签及注册资料载明的技术要求不一致组分和防腐剂含量超标;宣称祛痘类、牙膏类等其他类别产品共计检出不合格120批次(24.7%),涉及禁用组分非法添加、限用物质含量超标、微生物污染等问题。结论:牙膏类产品是国家化妆品监督抽检2022年新增的抽检类别,该类产品的不合格原因主要为微生物污染,应引起注意;染发类、洗发护发类和防晒类仍然是发现问题较集中的产品类别,应持续加强监管。基于2022年度国家化妆品监督抽检所发现的问题,建议加速完善检测方法开发,健全化妆品分类分级管理制度,构建一体式信息服务平台。

Objective:To analyze the data of unqualified cosmetics found in national cosmetics supervision and sampling test in 2022,summarize the possible causes and the harmfulness to consumers′health,and provide a reference for targeted supervision of cosmetics.Methods:The 2022 national cosmetics supervision and sampling test unqualified cosmetics notification data released on the official website of National Medical Products Administration(NMPA)was collected and sorted out.The category,place of origin,sampling place and other information of unqualified products were summarized to analyze the causes of the problems and put forward suggestions on cosmetics supervision.Results:A total of 486 batches of unqualified products were announced by 2022 national cosmetics supervision and sampling test,of which 366 batches(75.3%)of unqualified products were hair dyeing products,shampoo and hair care products,sunscreen products,and mainly because of inconsistent components with the technical requirements specified in the product label and registration information and excessive preservative content.120 batches(24.7%)of unqualified products were anti-acne cosmetics,toothpaste produtcs and other categories,and the unqualified items including illegal addition of prohibited components,excessive content of restricted substances,microbial pollution and other problems.Conclusion:Toothpaste products were the newly added category of national cosmetics supervision and sampling test in 2022,and the unqualified item of this category of products is microbial pollution,which should be noted.Hair dyeing,shampoo and hair care,sunscreen products are still the product categories that unqualified products are relatively concentrated and the supervision should continue to be strengthened on these products.Based on the problems found in 2022 national cosmetics supervision and sampling test,it is recommended to accelerate the development of testing methods,improve the classification and grading management system of cosmetics,and build an integrated information service platform.