摘要
化妆品风险评估是化妆品安全评估的重要组成部分,也是备案后检查的关注重点。风险评估资料是判断备案产品安全性的佐证资料,是备案后检查的重要依据。风险评估资料缺陷很容易造成无法判断产品安全性而导致产品暂停销售。根据《化妆品安全评估技术导则(2021年版)》要求,从备案后检查工作实际出发,对风险评估资料出现的常见问题进行归纳和解析,以期指导企业规范提交备案资料,也为基层监管部门开展备案后检查工作提供参考。
Risk assessment of cosmetics is an important part of safety assessment for cosmetics,which is also the focus of post-filing inspection.Risk assessment data are the supporting information to judge the safety of the registered product,which is also an important basis for post-filing inspection.The defect of risk assessment information can easily lead to the failure to judge the safety of the product and lead to the suspension of product sales.According to the requirements in the Technical Guidelines for Cosmetic Safety Assessment(2021 Edition),the common problems found in risk assessment data during the actual post-filing inspection work were summarized and analyzed.This work may guide enterprises to submit filing information in a standardized manner and may also provide reference for grassroots supervision departments.
作者
马晓青
邓娟
何乔桑
MA Xiao-qin;DENG Juan;HE Qiao-sang(Zhejiang Center for Drug and Cosmetic Evaluation,Hangzhou,Zhejiang 310000,China)
出处
《日用化学品科学》
CAS
2023年第7期10-14,共5页
Detergent & Cosmetics
基金
浙江省药品监督管理局科技计划项目(2023047)。
关键词
化妆品
风险评估
备案
检查要点
cosmetics
risk assessment
record
key points of inspection
