防晒化妆品人体功效测试标准方法及标准样品研究进展OA
Research Progress in Standardized Methods and Reference Standards for In Vivo Efficacy Testing of Sunscreen Cosmetics
根据我国化妆品法规,防晒产品属于特殊化妆品,应当由化妆品注册和备案检验机构按照《化妆品安全技术规范》(2015年版)的要求开展人体功效评价试验,试验过程需使用防晒标准品.本文梳理了国内外防晒化妆品人体功效测试标准方法的发展历程,并对比了国际标准化组织(ISO)相关标准、美国《联邦法规汇编》第21章(21CFR)及我国《化妆品安全技术规范》(2015 年版)对防晒功效标准样品规定的异同,提出研制我国防晒化妆品人体功效标准样品的必要性和实施路径.开发适合我国消费者皮肤特征的防晒功效标准样品,不仅能够填补国内人体功效评价防晒类标准样品的空白、完善标准体系,更可从根本上提升产品功效宣称评价的准确性,保障产品质量,突破国际标准的技术壁垒,为我国化妆品行业高质量发展提供依据和技术保障.
According to China's cosmetic regulations,sunscreen products are classified as special cosmetics.Their in vivo efficacy evaluation should be conducted by designated registration and filing testing institutions in compliance with the Safety and Technical Standards for Cosmetics(2015 Edition),a process that requires the use of sunscreen reference standards.This paper reviews the development of standardized methods for in vivo testing of sunscreen efficacy both in China and internationally.It compares the specifications for sunscreen efficacy reference standards among relevant International Organization for Standardization(ISO)standards,Title 21 of the United States Code of Federal Regulations(21CFR),and China's Safety and Technical Standards for Cosmetics(2015 Edition).Based on this analysis,the paper outlines the necessity and proposes an implementation pathway for developing China's own sunscreen efficacy reference standards for in vivo testing.Developing sunscreen efficacy reference standards tailored to the skin characteristics of Chinese consumers will not only fill the domestic gap in reference standards for sunscreen efficacy evaluation and improve the current standard system,but also fundamentally enhance the accuracy of product efficacy claim assessments,ensure product quality,and help overcome technical barriers associated with international standards.Ultimately,this will provide a scientific basis and technical support for the high-quality development of China's cosmetic industry.
宋乃宁;郑洪艳;张思华;蒲大潮;杨丽;岳章;代汉慧
中国质量检验检测科学研究院中国质量检验检测科学研究院中国质量检验检测科学研究院中国质量检验检测科学研究院中国质量检验检测科学研究院中国质量检验检测科学研究院中国质量检验检测科学研究院
化学化工
防晒化妆品人体功效测试标准样品国际比对研制建议
sunscreen cosmeticsin vivo efficacy testingreference standardinternational comparisondevelopment strategy
《中国食品药品监管》 2026 (6)
162-171,10
中国质量检验检测科学研究院基本科研业务费项目(2023JK019)
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