| 苏哲,罗飞亚,张凤兰,邢书霞,王钢力.化妆品纳米原料的国际监管及最新研究进展[J].中国药事,2021,35(1):227-236 |
| 化妆品纳米原料的国际监管及最新研究进展 |
| On Worldwide Supervision and Latest Research Progress about Cosmetic Nanomaterials |
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| DOI：10.16153/j.1002-7777.2021.02.016 |
| 中文关键词: 化妆品 纳米原料 监管 安全性评价 |
| 英文关键词: cosmetics nanomaterial supervision safety assessment |
| 基金项目: |
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| 中文摘要: |
| 目的：近年来随着纳米技术的不断发展，在世界范围内，纳米原料在化妆品中的应用日益增多， 其安全性和监管问题也备受关注，急需研究相应的管理制度和技术支撑体系。方法：在系统研究国际化妆品监管合作组织(ICCR)对化妆品纳米原料技术性文件工作基础之上，进一步跟踪消费者安全科学委员会(SCCS)等的最新研究进展以及相关法规动态，对化妆品纳米原料定义、实际使用情况、关键参数及其测量、安全性评价方法、监管要求等进行总结比对，结合我国监管现状进行分析。结果与结论：与传统原料相比，纳米原料具有一定的特殊性和需关注重点。建议借鉴ICCR、SCCS等的研究成果，收集我国化妆品纳米原料实际使用情况、开展方法学研究、建立安全性评价体系，建立健全我国化妆品纳米原料管理和技术体系。 |
| 英文摘要: |
| Objective: In recent years, with the continuous development of nanotechnology, nanomaterials have been increasingly used in cosmetics worldwide, and the safety assessment and regulatory issues have been commonly concerned. It is necessary to study the supervision and technical support system in this field. Methods: In this study, technical documents published by the International Cooperation on Cosmetics Regulation (ICCR) on cosmetic nanomaterials were analyzed, and some latest research work (such as from the SCCS)/regulation progress was followed. The definition, actual use, key parameters and measurement methods, safety assessment approaches and regulatory requirements about cosmetic nanomaterials were compared, and an analysis was made with consideration of the industrial development and regulatory reality in China. Results and Conclusion: Compared with conventional substances, nanomaterials have some certain characteristics and key points requiring special considerations. It is suggested to collect information about the actual use of cosmetic nanomaterials in China, the methodological research be carried out, a safety assessment approach be established, and finally a regulatory and technical system of such ingredients be built and improved in China. |
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