化妆品原料管理和原料安全信息报送制度探讨

Discussion of cosmetic ingredient management and regulatory system of cosmetic ingredient safety information submission

为落实《化妆品监督管理条例》要求,提高化妆品原料管理和安全性评价水平,国家药品监督管理局结合配套法规文件制修订和信息化建设工作,建立起化妆品原料安全信息报送制度。围绕此项工作,对旧法规背景下的化妆品原料管理概况和有关问题进行分析,对新法规体系下的化妆品原料管理思路和有关工作情况进行介绍,对化妆品原料安全信息报送的设计初衷和制度安排进行了阐述,并结合实际运行情况,就原料组成拆分原则、组分典型值/目标值和范围值、原料安全信息变更、原料安全信息文件签章等行业普遍关注的重点问题展开讨论,以期对行业提供技术参考。

In order to implement the Regulations on Supervision and Administration of Cosmetics(CSAR)and to improve the ingredient management and safety evaluation level of cosmetics,the National Medical Products Administration(NMPA)has established a system for submitting safety information of cosmetic ingredients,in combination with the drafting and revision of the supporting laws and regulations and the work of information system construction.Focused on this work,the authors analyze the general situation and related issues of the cosmetic ingredient management under the previous background of regulation and supervision,and introduce the general thoughts and arrangement under the new regulatory system of CSAR,so as to explain in detail the whole design and mechanisms of the safety information submission of cosmetic ingredients.Finally,based on practical feedback,the authors also discuss some key issues of common concern in the industry,such as the principle of composition identification and division,the concept of typical value/target value and range value of components,change of ingredient safety information,and the signature requirement of ingredient safety information documents.With these discussions,the work of safety information submission of cosmetic ingredients is reviewed and summarized,and some technical suggestions can also be provided.