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中国医药导刊 ›› 2024, Vol. 26 ›› Issue (7): 660-665.

• 监管科学 • 上一篇    下一篇

20192023年国家药监局通告微生物不合格化妆品问题分析

简秋瑜, 杨宇, 和云昱, 高元元, 殷园园*   

  1. 云南省食品药品审核查验中心,云南 昆明 650000
  • 收稿日期:2024-04-07 修回日期:2024-05-11 出版日期:2024-07-28 发布日期:2024-07-28

Analysis on Problems of Microbial Unqualified Cosmetics Announced by the NMPA from 2019 to 2023

  1. Yunnan Provincial Food and Drug Audit and Inspection Center Yunnan Kunming 650000, China
  • Received:2024-04-07 Revised:2024-05-11 Online:2024-07-28 Published:2024-07-28

摘要:

目的:了解20192023年国内化妆品微生物不合格情况,分析化妆品微生物不合格原因,掌握化妆品微生物质量安全风险防控点,为化妆品生产企业质量控制、监管部门靶向性监管提供参考。方法:收集20192023年国家药品监督管理局官网公告的监督抽检不合格化妆品中微生物不合格化妆品信息,对不合格产品的产地、产品类型、不合格的微生物指标进行统计,分析不合格原因。结果:微生物不合格化妆品中,标示广东生产的占比最多,为85.90%,其次是江苏和上海;剂型中贴面膜类占比最高,为58.97%,其次是牙膏类;不合格的微生物指标中菌落总数占比最高,为97.44%,其次是霉菌和酵母菌总数,为23.72%,铜绿假单胞菌检出占比为5.13%,耐热大肠菌群、金黄色葡萄球菌未检出。结论:微生物不合格与产品防腐剂成分含量不足、配方设计不合理、生产过程中污染有关,化妆品生产企业对产品的开发要考虑防腐体系的有效性及安全性,加强对相关政策和标准的学习,完善质量管理体系,提高化妆品生产质量管理水平。


关键词:  , 化妆品;微生物;不合格;监管

Abstract:

Objective: To analyze the reasons for microbial unqualification in domestic cosmetics from 2019 to 2023 understand the situation for unqualification master risk prevention and control points for microbial quality safety in cosmetics and provide references for the quality control by production enterprises and targeted supervision by regulatory authorities.Methods: Data on microbial unqualified cosmetics announced by the NMPA's supervised sampling of cosmetic products from 2019 to 2023 were collected.The origin product type unqualified microbial indices and reasons for unqualification were statistically analyzed.Results: Among the microbial unqualified cosmetics those produced in Guangdong had the highest proportion accounting for 85.90% followed by Jiangsu and Shanghai. The most common form of microbial unqualified cosmetics were maskswhich accounted for 58.97% followed by toothpaste. Regarding unqualified microbial indices the total number of colonies accounted for the highest proportion which was 97.44% followed by molds and yeas which was 23.72%. The detection rate for Pseudomonas aeruginosa was 5.13%while heat-resistant coliforms and Staphylococcus aureus were not detected. Conclusion Microbial unqualification is related to inadequate preservative contentunreasonable formula design and contamination during the production process. Cosmetic production enterprises should consider the effectiveness and safety of the antiseptic system during product developmentstrengthen understanding of relevant policies and standardsimprove the quality management systemand enhance the overall quality management level in cosmetics.

 

Key words: Cosmetics , Microbial , Unqualification , Supervise

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