国家药品监督管理局2019年通告不合格化妆品问题分析

Analysis On the Problems of Unqualified Cosmetics Announced by NMPA In 2019

目的:了解目前国内化妆品市场问题现状,掌握不合格产品的质量安全风险点,为今后化妆品市场监管方向提供参考。方法:对2019年国家药品监督管理局(以下简称国家药监局)网站通告的不合格化妆品的类别、产地、抽样地、不合格项目等信息进行汇总,对重点类别产品及突出问题进行统计分析。结果:国家药监局2019年共通告不合格化妆品399批次,产地以广东省居多,为321批次(80.5%),抽样地遍及全国29个省(区、市)。其中染发类产品354批次(88.7%),其他类别产品45批次。不合格问题包括pH值超标、限用物质含量超标、重金属含量超标、微生物超标及非法添加禁用物质等。其中,染发类和防晒类不合格产品还大量存在实际检出成分与批件配方及(或)标签标识成分不符的情况。不合格产品中的84批次为假冒产品。结论:染发类、防晒类和美白祛斑类产品质量安全风险较高,应加强对这些产品的监管,为化妆品消费者打造安全的用妆环境。

Objective:To understand the current situation of domestic cosmetics market problems,grasp the quality and safety risk points of unqualified products,and provide reference for the future supervision direction of cosmetics market.Methods:The category,place of origin,sampling place,unqualified items and other information of unqualified cosmetics announced on the website of National Medical Products Administration(NMPA)in 2019 were collected,and the key categories of products and outstanding problems were statistically analyzed.Results:In 2019,NMPA announced a total of 399 batches of unqualified cosmetics,with 321 batches(80.5%)in Guangdong Province as the most producing area,and 29 provinces(regions and cities)in China as the sampling sites.There are 354 batches(88.7%)of hair dyeing products and 45 batches of other products.The unqualified problems include the pH value exceeding the standard,the content of restricted substances exceeding the standard,the content of heavy metals exceeding the standard,the microorganism exceeding the standard and illegally adding prohibited substances.Among them,there are also a large number of hair dye and sunscreen products,which are not consistent with the ingredients of the approved formula and/or label.84 batches of unqualified products are fake products.Conclusion:The quality and safety risks of hair dye,sunscreen and whitening/freckle removing products are high.The supervision should be strengthened on these products to create safe environment for cosmetics consumers.