化妆品原料标准现状及缺失分析

doi:10.3969/j.issn.2097-2806.2023.06.009

摘要/Abstract

摘要：

化妆品的质量很大程度上取决于所用原料，通过分析和整理化妆品原料标准，发现目前国家和行业化妆品原料标准主要包括《化妆品安全技术规范》限用、准用物质，可能含有害杂质的原料、基础原料和功效成分这几类，团体标准更侧重于制订基础成分的原料标准和植物提取物的原料标准。有不少常用原料虽然没有化妆品专用的标准，但是可以参考、借鉴其他行业的标准。总体而言，有质量标准的原料仅占《已使用化妆品原料目录》中的小部分，热门的纳米成分标准缺失，植物提取物原料标准中的特征性指标设定也有所欠缺。缺乏统一的化妆品原料标准给企业的质量控制、政府部门的监督带来了不小的困难，今后建议加强可能含有害杂质的化妆品原料、功效性成分、纳米成分和植物提取物的原料标准制订，完善化妆品原料标准化体系。

关键词: 化妆品, 原料, 标准, 现状, 缺失

Abstract:

The quality of cosmetics greatly depended on the quality of raw materials. Through the analysis and sorting of cosmetics raw material standards, it was found that the existing national and industrial cosmetics raw material standards included limited and permitted substances in “Safety and Technical Standards for Cosmetics”, basic materials and raw materials that might contain harmful impurities. The number of preservative standards accounted for more than 1/4 of all national and industrial cosmetic raw material standards. There are some raw materials that might contain harmful impurities, such as methanol, asbestos and diethylene glycol, in ethanol, talc powder and glycerol, respectively. If the amount of these impurities is not controlled, it might cause health damage to the consumers. Different from the concerns of government departments, the group standard focuses on the raw material standards of basic raw materials and plant extracts. Although there are many common raw materials without special standards for cosmetics, they could refer to the standards of other industries. However, the attention should be paid to the applicability of these standards. For example, only a few standards of colorant food additives could fully meet the requirements of “Safety and Technical Standards for Cosmetics”. Nowadays, the raw materials standards only account for a small part of raw materials allowed in “Catalogue of used cosmetic raw materials”. The popular nano component standard is missing, and the setting of characteristic indicators in the raw material standards of plant extracts is also insufficient. The lack of unified cosmetic raw material standards brings great difficulties to the quality control of enterprises and the supervision of government. In the future, it is suggested to strengthen the draft of raw material standards for cosmetic raw materials that may contain harmful impurities, functional components, nano components and plant extracts, to improve the standardization system of cosmetic raw materials.

Key words: cosmetics, raw material, standard, current situation, deficiency

中图分类号:

TQ658

顾宇翔, 刘恕, 周羽. 化妆品原料标准现状及缺失分析[J]. 日用化学工业（中英文）, 2023, 53(6): 673-678.

Gu Yuxiang, Liu Shu, Zhou Yu. Analysis on the current situation and deficiency of cosmetic rawmaterial standards[J]. China Surfactant Detergent & Cosmetics, 2023, 53(6): 673-678.

图/表 2

表1

表2

参考文献 34

[1]	National Medical Products Administration. Announcement of National Medical Products Administration on Issuing the “Technical guidelines for safety assessment of cosmetics (version 2021)”[S/OL]. (2021-04-08) [2022-06-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210409160321110.html.
[2]	National Medical Products Administration. Announcement of National Medical Products Administration on Issuing the “Catalogue of used cosmetic raw materials (version 2021)”[S/OL]. (2021-04-27) [2022-06-01]. https://www.nmpa.gov.cn/zhuanti/hzhpxch2021/hzhp2021fgwj/20210430162707173.html.
[3]	Liu Guanfeng. Risk analysis and quality control of cosmetic raw materials[J]. Detergent & Cosmetics, 2020, 43 (9) : 50-53.
[4]	Boonchai W, Desomchoke R, Iamtharachai P. Trend of contact allergy to cosmetic ingredients in Thais over a period of 10 years[J]. Contact Dermatitis, 2011, 65: 311-316. doi: 10.1111/j.1600-0536.2011.01978.x pmid: 22077433
[5]	Liu Siran, Yang Yanwei, Zhu Ying. Investigation on the labeling of 26 allergenic fragrances in cosmetics[J]. Journal of Environment and Health, 2016, 33 (2) : 162-164.
[6]	National Medical Products Administration. Announcement of the State Food and Drug Administration on Approving the use of four raw materials such as ethyl lauroyl arginate HCl as cosmetic raw materials[S/OL]. (2020-12-21) [2022-06-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201228172412190.html.
[7]	Zhou Xiangyun, Liu Chenxin. The synthesis characteristics and applications of phenoxyethanol[J]. Chemical Industry Times, 1999, 5: 24-26.
[8]	Lu Jinrong, Zhou Qingjiang, Mo Lirong. Synthesis of triclosan[J]. The Chinese Journal of Modern Applied Pharmacy, 2003, 6: 491-492.
[9]	Huang Jianxiang, Huang Fuwei, Gu Yuxiang. Analysis on the standard and usage of preservative raw materials in cosmetics[J]. Flavour Fragrance Cosmetics, 2021, 3: 109-113.
[10]	National Medical Products Administration. Notice on printing and distributing the requirements for triethanolamine raw materials for cosmetics[S/OL]. (2020-11-02) [2022-06-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201228172412190.html.
[11]	National Medical Products Administration. Notice on printing and distributing the requirements for three raw materials such as ethanol for cosmetics[S/OL]. (2011-12-23) [2022-06-01]. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjhzhp/20111223120001182.html.
[12]	Beauty in Sight. South Korean plant preservatives have become a high incidence area for swindlers, who is to blame[EB/OL]. (2020-01-03) [2022-06-01]. https://mp.weixin.qq.com/s/mA9Yz5ctIRL4FDfMMoCDSg.
[13]	Xie Jiaai, Yang Bin, Hu Huimin. Research progress and development trend of anti-corrosion system without additive in cosmetics[J]. Guangdong Chemical Industry, 2019, 46 (20) : 56-58.
[14]	Li Zengting, Lv Xin, Li Qian, et al. Evaluation of preservation for preservative-free cosmetics[J]. China Surfactant Detergent & Cosmetics, 2021, 51 (10) : 975-980.
[15]	Xiao Shuxiong, Zeng Zijun, Liang Zhuye, et al. Current status and regulatory recommendations for the use of unlisted cosmetic preservatives[J]. Flavour Fragrance Cosmetics, 2020, 3: 77-81.
[16]	Li Shuo, Dai Jing, Li Li, et al. Determination of zinc oxide and titanium dioxide nanoparticles in imported sunscreen cosmetics[J]. China Surfactant Detergent & Cosmetics, 2019, 49 (9) : 621-626.
[17]	Manuja A, Kumar B, Kumar R, et al. Metal/metal oxide nanoparticles: Toxicity concerns associated with their physical state and remediation for biomedical applications[J]. Toxicology Reports, 2021, 8: 1970-1978. doi: 10.1016/j.toxrep.2021.11.020 pmid: 34934635
[18]	National Medical Products Administration. Announcement on the regulations on the administration of cosmetics registration and filing materials[S/OL]. (2021-02-26) [2022-06-01]. https://www.nmpa.gov.cn/zhuanti/hzhpxch2021/hzhp2021fgwj/20210304140747119.html.
[19]	National Medical Products Administration. Announcement on the regulations on the registration and filing of new cosmetic raw materials[S/OL]. (2021-02-26) [2022-06-01]. https://www.nmpa.gov.cn/zhuanti/hzhpxch2021/hzhp2021fgwj/20210304140454159.html.
[20]	Beauty in Sight. Benzene again, P & G urgently recalled[EB/OL]. (2021-12-19) [2022-06-01]. https://mp.weixin.qq.com/s/mA9Yz5ctIRL4FDfMMoCDSg.
[21]	Cosmetic Ingredient Expert Review Panel. Final report on the safety assessment of carbomers-934, -910, -934P, -940, -941, and -962[J]. Journal of the American College of Toxicology, 1982, 1 (2) : 109-141.
[22]	Jia Fang, Xie Wenjian, Dai Hang, et al. Security risk assessment of benzene content in aerosol air freshener[J]. Standard Science, 2016, 10: 40-42.
[23]	National Institutes for Food and Drug Control. Notice of the National Institutes for Food and Drug Control on soliciting opinions on the limit of benzene in cosmetics[EB/OL]. (2022-03-10) [2022-06-01]. https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/tongzhi/2022031012581417970.html.
[24]	Peng Lin, Liu Yanming, Long Haiyan, et al. Comparison of the related substances in benzalkonium chloride at home and abroad[J]. China Pharmacist, 2016, 19 (10) : 1996-1998.
[25]	Xi Juan, Shen Hanxi, Hang Lei, et al. Research development and trends of preservative chlorphenesin in cosmetics[J]. Studies in Synthetic Chemistry, 2018, 6 (4) : 55-59. doi: 10.12677/SSC.2018.64009
[26]	Hu Wenjing, Yu Wenjie, Pei Shuang, et al. Safety evaluation and preparation method of cosmetic preservative chlorophenylene glycol ether[J]. Beijing Daily Chemical, 2015, 2: 28-30.
[27]	Guo Meng, Wang Wei, Ding Zheng. Study on multivariate informatization of crude drug panax notoginseng total aaponins UPLC fingerprint[J]. Chinese Journal of Traditional Medical Science and Technology, 2020, 27 (5) : 711-715.
[28]	Muzna S, Muhammad N, Adeeba K, et al. Chemical fingerprinting of three Anemone species and an adulteration study to detect cross mixing of medicinal plants by HPLC-HR-ESI-MS/MS method[J]. Journal of King Saud University-Science, 2021, 33 (5) : 101461-101463. doi: 10.1016/j.jksus.2021.101461
[29]	Jiang Yangming, Zou Yunyun, Huang Tao, et al. NMR fingerprints of eucommia ulmoides oliver[J]. Chinese Journal of Magnetic Resonance, 2017, 34 (4) : 453-464.
[30]	Xu Xiao, Zhang Yan, Liu Xiaoyun, et al. Promotion on quality standard of Fufang E'jiao Jiang[J]. Chinese Traditional and Herbal Drugs, 2021, 52 (20) : 6226-6233.
[31]	Xia Lizhen, Li Chunjiao, Lai Zengfa. Determination of aucklandin lactone and dehydrocarbactone in Aucklandia by QAMS[J]. Fujian Journal of Traditional Chinese Medicine, 2013, 44 (3) : 52-54.
[32]	Guo Dongxiao, Lin Yongqiang, Lin Lin, et al. Advance in quality control for traditional Chinese medicines by QAMS[J]. Journal of Pharmaceutical Research, 2013, 32 (9) : 530-533.
[33]	Enescu C, Bedford L, Potts G, et al. A review of topical vitamin C derivatives and their efficacy[J]. Journal of Cosmetic Dermatology, 2022, 21 (6) : 2349-2359. doi: 10.1111/jocd.v21.6
[34]	Magdalena H, Gottfried R, Hanspeter K, et al. Topical delivery of acetyl hexapeptide-8 from different emulsions: Influence of emulsion composition and internal structure[J]. European Journal of Pharmaceutical Sciences, 2015, 68 (20) : 27-35. doi: 10.1016/j.ejps.2014.12.006

标准	特征性单一成分	特征性类别成分
QB/T 2488—2006	芦荟苷	多糖、O-乙酰基
QB/T 4951—2016	光甘草定	黄酮
T/CAFFCI 14—2018	红景天苷
T/CAFFCI 15—2018		总多酚
T/CAFFCI 17—2019	积雪草苷、羟基积雪草苷
T/CAFFCI 47—2021	芍药苷
T/CAFFCI 48—2021		总黄酮醇苷
T/HPCIA 008—2021		总皂苷
T/HPCIA 009—2021	柚皮苷
T/HPCIA 010—2021		羟基萘醌总色素
T/SDCIA 1007—2022	亚麻酸、亚油酸、油酸
T/SHRH 037—2021	维生素E、角鲨烯	甾醇总量、脂肪酸组成

发酵虫草菌粉产品	各版本《中国药典》的规定
金水宝胶囊	2000年版：薄层色谱鉴别氨基酸、3种核苷、甘露醇，高效液相色谱测定腺苷；
金水宝胶囊	2015年版：新增高效液相色谱测定物质5种核苷和麦角甾醇
百令胶囊	2005年版：薄层色谱鉴别3个氨基酸，高效液相色谱测定腺苷、尿苷等6个成分，氨基酸分析仪测定总氨基酸含量，滴定法测定甘露醇含量；
	2010年版：新增麦角甾醇的鉴别；
	2015年版：新增高效液相色谱法鉴别氨基酸色谱峰