我国化妆品产品稳定性研究与管理现状的探讨

doi:10.3969/j.issn.2097-2806.2024.02.012

摘要/Abstract

摘要：

化妆品的稳定性是评价化妆品质量与安全的重要因素，也是化妆品使用性与功效性的保障。本文对比了全球化妆品稳定性研究的监管体系和稳定性文件情况，梳理了国内化妆品产品有效期、稳定性及监管等相关文件的内容。通过对“监管、协会和企业”三个板块电子问卷调查结果，分析我国目前化妆品产品稳定性研究现状，发现工作开展面临的主要问题。借鉴国外化妆品产品稳定性研究的经验及我国食品药品等行业领域产品稳定性研究情况，对我国化妆品产品稳定性研究方向、技术文件的制定和监管服务提出建议。

关键词: 化妆品, 产品稳定性, 管理现状, 建议

Abstract:

The stability of cosmetics is an important factor to evaluate the quality and safety of cosmetics, and is also the guarantee of the usability and efficacy of cosmetics. This paper compares the regulatory system and stability documents of the global cosmetics stability research, and sorts out the contents of the shelf life, stability and supervision of domestic cosmetics products. Based on the results of the electronic questionnaire survey of “supervision, association and enterprise”, the current situation of the stability of cosmetics products in China is analyzed, and the main problems faced by the work are found. Suggestions of the stability of cosmetic products in China are put forward on the research direction, the formulation of technical documents and the regulatory service, based on the experience of foreign cosmetic product stability research and the research situation of product stability in food and drug industries.

Key words: cosmetics, product stability, management status, recommendations

中图分类号:

TQ658

潘小红, 高梓琪, 陈真, 殷帅, 黄海萍, 胡斌. 我国化妆品产品稳定性研究与管理现状的探讨[J]. 日用化学工业（中英文）, 2024, 54(2): 201-208.

Xiaohong Pan, Ziqi Gao, Zhen Chen, Shuai Yin, Haiping Huang, Bin Hu. Discussion on the current situation of research and management on the stability of cosmetic products in China[J]. China Surfactant Detergent & Cosmetics, 2024, 54(2): 201-208.

图/表 3

表1

各国家、地区和组织化妆品稳定性相关文件"

序号	年份	国家、地区或组织	概念	文件名称	特点要求
1	1992	IFSCC	稳定性测试的一般目标是确定待销售的容器中的特定产品在待销售的市场条件下是否具有足够的保质期	《稳定性测试原理》	汇总不同参考文献的稳定性试验条件，不涉及具体参数
2	2004	CE、COLIP/CTFA	稳定性测试化妆品的目的是确保新产品或改性产品在适当条件下储存时符合预期的物理、化学和微生物质量标准以及功能和美观	《化妆品稳定性测试指南》	重点内容为稳定性研究实用指导，侧重指导货架期稳定性研究设计，不规定具体参数、项目、标准
3	2018	国际标准化组织	稳定性研究旨在评估消费者在适当条件下储存和使用产品时，产品保持所需物理、化学微生物特性以及功能和感官特性的能力。更简单地说，稳定性研究的目的是确定产品的货架期，并评估包装中的产品在其销售和使用的市场条件下是否稳定	国际准则ISO/TR 18811:2018《化妆品稳定性测试指南》	对现成参考文献的回顾，可以作为一个技术/科学框架，不规定条件、参数或标准
4	2013	欧盟	－	《欧盟化妆品法规1223/2009》	明确规定生产企业必须提供产品在正常储存条件下的稳定性信息，作为化妆品安全报告（CPSR）的一部分
5	2004	巴西	化妆品的稳定性研究提供的信息表明了产品从生产到有效性结束的各种条件下的相对稳定性水平	《化妆品稳定性指南》	内容全面、详细。卫生当局进行检查时要求的稳定性信息，但每家公司可以根据需要合理调整
6	2011	韩国	化妆品稳定性测试是为了设定化妆品的储存方法和使用期限，这是评价质量稳定性的试验	《化妆品稳定性测试指南》	试验条件描述详细，指南所述事项不具有法律效力
7	2017	日本	－	《化妆品医药外品生产销售指南》	参考医药部外品的稳定性实验，关注功效成分的测试

表1

表2

图1

参考文献 36

[1]	Liu Yinghui, He Xinxin, Cao Jin, et al. Discussion on the research content for cosmetic product safety report and stability study[J]. China Surfactant Detergent & Cosmetics, 2022, 45 (2) : 19-23.
[2]	The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q1A-Q1F stability[EB/OL]. (2003-02-06) [2022-12-26]. https://www.ich.org/page/quality-guidelines.
[3]	State Food and Drug Administration. Notice on the issuance of 16 technical guidelines including chemical drug stability research (No.106 of 2005)[EB/OL]. (2006-12-30) [2022-12-26]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/200503180101201.html.
[4]	State Food and Drug Administration. Notice on printing and distributing the technical guidelines for stability research of traditional chinese medicine and natural drugs (No.678 of 2006)[EB/OL]. (2006-12-30)[2022-12-26]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20061230010101209.html.
[5]	Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’s Republic of Ehina:four parts (Edition 2020)[M]. Beijing: China Pharmaceutical Science and Technology Press, 2020: 457-459.
[6]	State Food and Drug Administration. Notice on the issuance of technical guidelines for stability research of biological products (No.3 of 2015)[EB/OL]. (2015-04-15) [2022-12-26]. https://www.nmpa.gov.cn/dire-ctory/web/nmpa/xxgk/ggtg/qtggtg/20150415120001189.html.
[7]	State Administration of Market Supervision and Administration. Announcement on the issuance of the items and requirements of application materials for registration of formula food for special medical purposes (Trial) (2017 Revision) and the requirements for stability research of formula food for special medical purposes (Trial) (2017 Revision) (No.108 of 2017)[EB/OL]. (2019-03-11) [2022-12-26]. https://www.samr.gov.cn/tssps/tzgg/zjwh/201903/t20190311_291856.html.
[8]	State Food and Drug Administration. Notice of the general office of the food and drug administration on printing and distributing the guiding principles for the stability test of health food (No.3 of 2013)[EB/OL]. (2013-12-02) [2022-12-26]. http://www.cfe-samr.org.cn/zcfg/bjsp_134/gfxwj/zcwj/202208/t20220802_4418.html.
[9]	State Administration of Market Supervision and Administration. Announcement on matters related to formula registration of infant formula milk powder products (No.10 of 2021)[EB/OL]. (2021-03-24) [2022-12-26]. https://gkml.samr.gov.cn/nsjg/tssps/202103/t20210324_327214.html.
[10]	Ministry of Agriculture and Rural Affairs. Notice on printing and distributing the guidelines for stability test of feed additives (Trial)[EB/OL]. (2008-12-30) [2022-12-26]. http://www.moa.gov.cn/govpublic/XMYS/201006/t201006 06_1535143.htm.
[11]	Ministry of Mgriculture and Rural Affairs. Announcement No.683 of the ministry of agriculture of the People’s Republic of Ehina[EB/OL]. (2006-08-20) [2022-12-26]. http://www.moa.gov.cn/nybgb/2006/dbq/201806/t20180616_6152332.htm.
[12]	State Administration of Market Supervision and Administration, National Standardization. Evaluation method of disinfectant stability: GB/T 38499-2020[S/OL].[2022-12-26]. http://down.foodmate.net/standard/sort/3/72930.html.
[13]	British Standards Institution. Cosmetics-guidelines on the stability testing of cosmetic products:ISO/TR 18811-2018[S/OL].[2022-12-26]. https://www.iso.org/standard/63465.html.
[14]	International Federation of the Societies of Cosmetic Chemists. IFSCC monograph Number 2-The fundamentals of stability testing [S]. Cranford, NJ: Micelle Press, 1992: 23.
[15]	Cosmetics Europe-the Personal Care Association. Guidelines on stability testing of cosmetic products[S/OL]. [2022-12-26]. https://wenku.baidu.com/view/67032e65f5335a8102d2202a.html?_wkts_=1706107301468&bdQuery=Guidelines+on+stability+testing+of+cosmetic+products.
[16]	Food and Drug Administration. Federal food, drugs and cosmetics act (FD&C Act Chapter Ⅵ: Cosmetics)[EB/OL]. [2022-12-26]. https://www.fda.gov/cosmetics.
[17]	The Food and Drug Administration. Cosmetic Labeling Guide[EB/OL]. [2022-12-26]. https://www.fda.gov/cosmetics/cosmetics-labeling.
[18]	European Commission. Regulation (EC) No1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products[EB/OL]. (2009-01-01) [2022-12-26]. https://xueshu.baidu.com/usercenter/paper/show?paperid=44add80c5221b571c5744b6ad49bd4c7&site=xueshu_se.
[19]	National Health Surveillance Agency. Cosmetics products stability guide[S]. Brazil: Anvisa Publishing House, 2004.
[20]	Korean Food and Drug Administration, Guidelines on stability testing of cosmetic products[S]. 2011. (2011-06) [2022-12-26]. https://www.mfds.go.kr/eng/wpge/m_24/de011014l001.do.
[21]	Seminar on Guidelines for the Manufacturing and Sales of Cosmetics and Pharmaceutical Products. Manufacturing and sales guide for cosmetics and pharmaceutical products 2017[M]. Japan: Pharmaceutical Daily, 2020: 141-145.
[22]	State Council of the PRC. Regulation on the supervision and administration of cosmetics (No. 727)[EB/OL]. (2020-06-16) [2022-12-26]. http://www.gov.cn/zhengce/2020-12/27/content5573797.html.
[23]	National Medical Products Administration. Announcement on issuing the regulations on the administration of cosmetics registration and filing data (No.32 of 2021)[EB/OL]. (2021-03-04) [2022-12-26]. https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20210304140747119.html.
[24]	National Medical Products Administration. Announcement on the issuance of the technical guidelines for the safety assessment of cosmetics (2021) (No.51 of 2021)[EB/OL]. (2021-04-08)[2022-12-26]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210409160436155.html.
[25]	Jiangsu Provincial Health Care Food and Cosmetics Safety Association. Guidelines for stability test of cosmetics: T/SHFCA 002-2021[S/OL]. (2021-10-12) [2022-12-26]. http://down.foodmate.net/standard/sort/12/105141.html.
[26]	Li Hongxia, Han Weina, Hou Xiaoyu, et al. Consideration of compatibility and stability of raw materials in physical and chemical quality control of cosmetics[J]. Detergent & Cosmetics, 2022, 45 (11) : 7-12.
[27]	He Xinxin, Wang Xuemei, Wang Gangli, et al. UPLC-Q-TOF/MS qualitative analysis method and stability study of 8 ultraviolet absorbers in sunscreen cosmetic emulsions[J]. China Surfactant Detergent & Cosmetics, 2021, 51 (3) : 220-226.
[28]	Xie Agui. Stability of nicotinamide in cosmetics[J]. Flavour Fragrance Cosmetics, 2022 (2) : 37-40.
[29]	Zhang Qiang, Cui Jun, Gu Hua, et al. Determination of aloin in cosmetics and its stability[J]. China Surfactant Detergent & Cosmetics, 2019, 49 (3) : 199-202, 208.
[30]	Wang Hanning, Liu Xiaoqing, Jiang Ligang. Effect of preservative system commonly used in cosmetics on liposome stability[J]. Flavour Fragrance Cosmetics, 2022 (4) : 109-115.
[31]	Qiu Bingyi. Emulsification and its application in cosmetics industry (Ⅱ): Stability and influencing factors of emulsion (continued 1)[J]. China Surfactant Detergent & Cosmetics, 1999 (2) : 48-53.
[32]	Peng Shiqi, Peng Yinghua, Zhang Rongcun, et al. Study on the colored stability of the application of arnebiae radix oil in cosmetics[J]. GuangDong Chemistry, 2021, 48 (19) : 64-66.
[33]	Zhuang Zixiong, Zhan Suhui, Zheng Muchuang, et al. Experimental study on the stability of sunset yellow in cosmetics[J]. GuangDong Chemistry, 2020, 47 (9) : 34-35, 51.
[34]	Yang Jiahui, Liang Rong, Yang Cheng. Cosmetic emulsions and new technologies of emulsification (Ⅲ): stability of multiple emulsions and their application in cosmetics[J]. China Surfactant Detergent & Cosmetics, 2021, 51 (6) : 477-484, 495.
[35]	Chen Yuwei, Guo Meng, Wang Bingjie, et al. Effects of low-temperature instantaneous high-speed shearing on the stability of cosmetic products[J]. China Surfactant Detergent & Cosmetics, 2020, 43 (1) : 39-43.
[36]	National Medical Products Administration. Announcement on the release of cosmetics classification rules and classification catalog (No.49 of 2021)[EB/OL]. (2021-04-09) [2022-12-26]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210409160151122.html.

序号	影响因素试验			加速试验			长期试验
序号	t/天	数量/家	百分比/%	t/天	数量/家	百分比/%	t/年	数量/家	百分比/%
1	0≤t≤20	280	67	0≤t≤15	232	55	0≤t≤0.5	255	61
2	20<t≤30	52	12	15<t≤30	48	11	0.5<t≤2	38	9
3	30<t≤90	54	13	30<t≤90	91	22	2<t≤3	97	23
4	t>90	33	8	t>90	48	12	t>3	29	7