国内外严重化妆品不良反应纳入标准对比研究

Inclusion Criteria of Severe Adverse Reactions of Cosmetics at Home and Abroad:a Comparative Study

目的完善我国现行严重化妆品不良反应纳入标准。方法归纳、整理世界主要国家和地区的严重化妆品不良反应纳入标准,与我国现行标准进行对比,结合我国化妆品不良反应监测工作实际情况,分析我国相关标准制订的科学性、合理性。结果与世界主要国家和地区相比,我国严重化妆品不良反应纳入标准最全面,但在部分表述上纳入范围偏小。结论需在广泛征求意见的基础上,对我国严重化妆品不良反应纳入标准进行完善和优化,并制订预警规则,加强严重化妆品不良反应的监测。

Objective To improve the inclusion criteria for severe adverse reactions of cosmetics in China.Methods The inclusion criteria of severe adverse reactions of cosmetics in major countries and regions of the world were summarized and compared with the current criteria in China.Based on the actual situation of the monitoring of adverse reactions of cosmetics in China,the scientificity and rationality of the formulation of relevant criteria in China were analyzed.Results Compared with the major countries and regions in the world,the inclusion criteria of severe adverse reactions of cosmetics in China were the most comprehensive,but the inclusion scope of some expressions was relatively small.Conclusion On the basis of extensive consultation,it is necessary to improve and optimize the inclusion criteria of severe adverse reactions of cosmetics in China,formulate early warning rules and strengthen the monitoring of severe adverse reactions of cosmetics.