摘要
目的:分析近两年国家化妆品监督抽检报告公布的三类特殊用途化妆品(染发类、防晒类、祛斑美白类)常见的不合格项目,并提出相应建议,以减少特殊用途化妆品不良事件对消费者造成的健康危害。方法:收集国家药品监督管理局官方网站2018年3月至2019年12月发布的不合格化妆品的通告,运用SPSS软件将原本的非结构化数据转化为结构化数据,在此基础上,利用综合数据分析方法,分析2018、2019年染发类、祛斑美白类、防晒类三类特殊用途化妆品常见抽检不合格项目的规律和趋势。结果:在上述时间段内,染发类化妆品的常见不合格项目为检出批件及标签未标识的成分(2018年83%、2019年83%)、未检出批件及标签标识的成分(2018年59%、2019年60%)及其他批件与标签标识方面问题(2018年33%、2019年51%)等;防晒类化妆品的常见不合格项目为未检出批件及标签标识的成分(2018年67%、2019年60%)、检出批件及标签未标识的成分(2018年30%、2019年47%)及其他批件与标签标识方面问题(2018年50%、2019年27%)等;祛斑美白类化妆品常见的不合格项目为有毒物质超标(2019年57%)、使用化妆品禁用成分(2019年29%)及其他批件与标签标识方面问题(2019年14%)。结论:应当加强化妆品生产企业的全过程监管,完善化妆品质量安全风险管控体系,开展化妆品禁限用组分检测方法研究,完善成分检测方法和功效评价方法,加大惩处力度等。
Objective:To analysis the common unqualified items of three kinds of special-purpose cosmetics(hair dye,sunscreen,freckle and whitening),and put forward corresponding improvement suggestions,so as to reduce the health hazard caused by adverse events of special-purpose cosmetics to consumers.Methods:The bulletins on cosmetics sampling inspection issued on the official website of National Medical Products Administration(NMPA)from March 2018 to December 2019 were collected.SPSS software was used to transform the original unstructured data into structured data,and the comprehensive data analysis method was used to analyze the rule and trend of common unqualified items of three kinds of special-purpose cosmetics(hair dye,sunscreen,freckle and whitening).Results:In the above period,the common unqualified items of hair dye cosmetics were unmarked ingredients in detected label approval documents(83%in 2018 and 83%in 2019),undetected ingredients in label approval documents(59%in 2018 and 60%in 2019),and problems in other approvals and label identification packaging compared with approval documents(33%in 2018 and 51%in 2019).The common unqualified items of sunscreen cosmetics were undetected ingredients in label approval documents(67%in 2018 and 60%in 2019),unmarked ingredients in detected label approval documents(30%in 2018 and 47%in 2019),and problems in other approvals and label identification(50%in 2018 and 27%in 2019).The most common unqualified items in freckle and whitening cosmetics were excessive toxic substances(57%in 2019),use of banned cosmetic ingredients(29%in 2019),and problems in other approvals and label identification(14%in 2019).Conclusion:The whole process supervision of cosmetic manufacturing enterprises should be strengthened,the quality and safety risk control system of cosmetics should be improved,the detection methods of prohibited components of cosmetics should be studied,the detection methods of ingredients and the evaluation methods of efficacy should be improved,and the punishment should be strengthened.
作者
王颖香
于淼
张薇薇
席晓宇
顾淼
WANG Yingxiang;YU Miao;ZHANG Weiwei;XI Xiaoyu;GU Miao(The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Jiangsu Nanjing 211198, China;Center For Information, National Medical Products Administration, Beijing 100044, China)
出处
《中国医药导刊》
2020年第8期588-592,共5页
Chinese Journal of Medicinal Guide
基金
国家药品监督管理局信息中心委托项目(项目编号:2019NMPAICKY04,项目名称:互联网+药品生产监管数据融合分析研究)
中国药科大学“双一流”学科创新团队建设项目(项目编号:No.CPU2018GY39)。
关键词
化妆品
监督抽检
质量
特殊用途化妆品
不合格项目分析
Cosmetics
Supervision and sampling inspection
Quality
Special-purpose cosmetics
Unqualified items analysis
