2016年-2020年全国微生物不合格市售化妆品的特征分析  

Analysis of the characteristics of national-wide microbiology-unqualified marketed cosmetics from 2016 to 2020

作　　者：孙晶 蔺静 王小兵 张中湖 黄传峰[3] SUN Jing;LIN Jing;WANG Xiao-bing;ZHANG Zhong-hu;HUANG Chuan-feng(Shandong Institute for Food and Drug Control,Key Laboratory of Quality Control of Cosmetic Raw Materials,National Medical Products Administration,Ji'nan,Shandong 250101,China;不详)

机构地区：[1]山东省食品药品检验研究院国家药品监督管理局化妆品原料质量控制重点实验室,山东济南250101 [2]山东汉方日用化妆品有限公司,山东济南251400 [3]中国食品药品检定研究院食品化妆品检定所,北京100050

出　　处：《中国卫生检验杂志》2022年第2期241-243,252,共4页Chinese Journal of Health Laboratory Technology

基　　金：山东省重点研发计划(软科学项目)(2020RKB24002)。

摘　　要：目的分析微生物不合格化妆品的类别特征和不合格原因,为企业生产质量控制提供参考,为化妆品靶向性监管提出建议。方法收集2016年—2020年国家药监局官网公告的监督抽检不合格或问题化妆品3469批,其中,微生物不合格171批,对产地、功能宣称、剂型、采样点类型、销售地及地域类型、不合格原因进行统计分析。结果标示广东产占比最多,为71.8%,其次是上海和江苏;功能宣称主要是保湿和清洁类化妆品,分别占比41.0%和23.5%;剂型主要是贴膜类占比最高,其次为水剂类;采自专卖店和生产企业的批次最多,分别占比26.3%和23.4%;采自地级市和生产企业的微生物不合格产品数量高于其他地域类型。结论微生物不合格与生产过程密切相关,应加强对小微企业的技术帮扶,并依据微生物高风险化妆品类别特征针对性设计监督抽检方案,提高抽检效能。Objective To analyze the category characteristics and the reasons for the unqualified cosmetics of microbiologically unqualified,so as to provide reference for production quality control of enterprises,and make recommendations for targeted supervision of cosmetics.Methods A total of 3469 batches of unqualified or problematic cosmetics announced on the official website of the State Food and Drug Administration from 2016 to 2020 were collected.Among them,171 batches of cosmetics with unqualified microorganisms were statistically analyzed on the origin,function claim,dosage form,sampling point type,sales place and geographical type,and reasons for unqualified.Results The largest proportion of products is from Guangdong(71.8%),followed by Shanghai and Jiangsu.Functional claims are mainly moisturizing and cleansing cosmetics,accounting for 41.0%and 23.5%respectively.The dosage form is mainly the film type,followed by the liquid type.The batches of products from specialty stores and manufacturing companies are the most,accounting for 26.3%and 23.4%respectively.The number of unqualified microbiological products collected from prefecture-level cities and production enterprises is higher than that of other regional types.Conclusion Microbiological unqualified cosmetics are closely related to the production process.Technical assistance to small and micro enterprises should be strengthened,and supervision and sampling plans should be designed according to the characteristics of microbiological high-risk cosmetics to improve the efficiency of sampling.

关 键 词：化妆品 微生物 监督抽检 功能 剂型 

分 类 号：R446[医药卫生—诊断学]