新法规和标准体系下的化妆品完整版安全评估路径研究

摘要：

【目的】从标准化角度，引导化妆品注册人/备案人进一步提升完整版安全评估路径和技术能力。【方法】通过对一系列新发布与实施的标准和规范解读，对比简化版安全评估要求，着重研究新增的防腐挑战、产品稳定性、产品与包材的相容性等评估要求。【结果】建立完整版安全评估的评估路径和测试方案，可降低评估和检测的技术门槛，并解决目前原料的种类和用量选择受限、检测成本和评估周期剧增等难题。【结论】通过新法规和先进标准引领，完整版安全评估可提升化妆品质量安全、促进科技创新和高质量发展。

Abstract:

[Objective] The paper aims to guide cosmetic registrants/notification applicants to further enhance their complete version of cosmetic safety assessment path and technical capabilities from the standardization perspective. [Methods] By interpreting a series of newly released and implemented regulations and standards, and comparing the simplified version, this study focuses on the new and essential assessment requirements such as preservative challenge tests, product stability tests, and compatibility assessments between products and packaging materials. [Results] Establishing the assess path of the complete version and testing plan can lower the threshold for assessment and test techniques, and solve current difficulties such as limited selection of ingredients’ types and contents, sharp increase in testing costs and the duration of assessments. [Conclusion] Guided by latest regulations and advanced standards, the complete version can enhance the quality and safety of cosmetics, boost technological innovation, and promote high-quality development. 

引用格式：杨木杨，苏小霞，朱芸芸，等.新法规和标准体系下的化妆品完整版安全评估路径研究[J].标准科学，2025(6)：58-68.

基金项目：本文受江苏省市场监督管理局科技计划项目“日化原料开发及产品功效与风险技术体系构建与应用”（项目编号：KJ2025015）资助。

作者简介： 杨木杨，硕士，工程师，研究方向为化妆品检测、安全评估。 王飞轩，通信作者，硕士，高级工程师，研究方向为化妆品备案、标准化。