2017—2021年我国进口防晒化妆品注册情况分析

doi:10.3969/j.issn.2097-2806.2023.10.012

摘要/Abstract

摘要：

通过查询国家药监局网站公布的化妆品批件信息，对2017—2021年我国进口防晒化妆品的批件数量、原产国、紫外线防御能力、剂型和配方中防晒剂等数据进行归纳、整理和分析。结果显示：2017—2021年五年间，我国共发放进口防晒化妆品批件3 057件，韩国是进口防晒化妆品的最大原产国；紫外线防御能力方面，SPF值未见明显增长，高PFA值产品占比有明显提高；进口防晒化妆品主要剂型为膏霜乳，喷雾剂有逐渐增加的趋势；产品配方中使用频率最高的防晒剂是安全系数相对较高的甲氧基肉桂酸乙基己酯。针对上述分析结果，结合文献报道、法规监管和社会热点等方面内容，进一步剖析以期全方位了解我国进口防晒化妆品情况，为我国化妆品市场监管和国内化妆品企业研发提供有益的借鉴和参考。

关键词: 进口防晒化妆品, 原产国, 紫外线防御能力, 剂型, 防晒剂

Abstract:

By inquiring the information on the approval documents for cosmetics published on the website of CFDA, the number of approval documents, country of origin, ultraviolet defense ability, dosage form, and sunscreen agents for the import of sunscreen cosmetics in China from 2017 to 2021 were summarized and analyzed. The results showed that 3 057 approval documents for imported sunscreen cosmetics were issued in China during the past five years from 2017 to 2021, and South Korea was the largest country of origin of imported sunscreen cosmetics; in terms of ultraviolet defense ability, SPF value did not significantly increase, and the proportion of products with high PFA values was significantly increased; the main dosage form of imported sunscreen cosmetics was cream, while spray had a gradually increasing trend; the sunscreen agent with the highest frequency of use in the product formulas was ethylhexyl methoxycinnamate with a relatively high safety. Based on the analysis results above, further analysis was made combined with literature reports, regulatory supervision and social hotspots, which was helpful to fully understand the situation of imported sunscreen cosmetics in China and provide useful references for the market supervision of cosmetics in China and the research and development of cosmetics for domestic enterprises.

Key words: imported sunscreen cosmetics, country of origin, UV protection, dosage form, sunscreen agent

中图分类号:

TQ658

塔娜, 余振喜, 高家敏, 张凤兰, 王钢力. 2017—2021年我国进口防晒化妆品注册情况分析[J]. 日用化学工业（中英文）, 2023, 53(10): 1204-1210.

Ta Na, Yu Zhenxi, Gao Jiamin, Zhang Fenglan, Wang Gangli. Analysis on registration of imported sunscreen cosmetics in China in 2017—2021[J]. China Surfactant Detergent & Cosmetics, 2023, 53(10): 1204-1210.

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参考文献 19

[1]	Deng Jing. Development status of sunscreen cosmetics market[J]. Detergent & Cosmetics, 2018, 41 (6) : 1-7.
[2]	Yu Shujuan, Zheng Yubin, Du Jie, et al. Review on the development of sunscreen[J]. China Surfactant Detergent ＆ Cosmetics, 2005, 35 (4) : 248-251.
[3]	Fan Yuping. Review on efficacy evaluation and future development for sunscreens[J]. Flavour Fragrance Cosmetics, 2013 (4) : 49-54.
[4]	Kerr A C. A survey of the availability of sunscreen filters in the UK[J]. Clinical and Experimental Dermatology, 2011, 36 (5) : 541-543. doi: 10.1111/j.1365-2230.2010.04007.x pmid: 21434977
[5]	W·John Kirk, Niu Jinping, Han Yaming. Market trend of sunscreen cosmetics in Europe[J]. Detergent & Cosmetics, 2003, 26 (3) : 6-8.
[6]	China Food and Drug Administration. CFDA announcement on issuing the requirements for the administration of sunscreen effect marking of sunscreen cosmetics[R]. Beijing: CFDA, 2016.
[7]	Sambandan Divya R, Ratner Desiree. Sunscreens: an overview and update[J]. Journal of the American Academy of Dermatology, 2011, 64 (4) : 748-758. doi: 10.1016/j.jaad.2010.01.005 pmid: 21292345
[8]	Farberg A S, Rigel A C, Rigel D S. Online survey of US dermatologists’ sunscreen opinions: perceptions, recommendation factors, and self-usage[J]. J Drugs Dermatol, 2016, 15: 1121-1123. pmid: 27602976
[9]	Teplitz Rebeca W, Glazer Alex M, Svoboda Ryan M, et al. Trends in US sunscreen formulations: Impact of increasing spray usage[J]. Journal of the American Academy of Dermatology, 2018, 78 (1) : 187-189. doi: S0190-9622(17)32169-2 pmid: 29241780
[10]	Sambandan D R, Ratner D. Sunscreens: an overview and update[J]. J Am Acad Dermatol, 2011, 64 (4) : 748-758. doi: 10.1016/j.jaad.2010.01.005 pmid: 21292345
[11]	Lorigo M, Mariana M, Cairrao E. Photoprotection of ultraviolet-B filters: updated review of endocrine disrupting properties[J]. Steroids, 2018, 131: 46-58. doi: S0039-128X(18)30014-X pmid: 29360537
[12]	Zhang Guimin. Research progress and safety of cosmetic sunscreen agents[J]. Detergent & Cosmetics, 2003, 26 (3) : 23-25, 30.
[13]	Chaiyabutr C, Sukakul T, Kumpangsin T, et al. Ultraviolet filters in sunscreens and cosmetic products-a market survey[J]. Contact Dermatitis, 2021, 85 (1) : 58-68. doi: 10.1111/cod.13777 pmid: 33399219
[14]	Palm M D, O’Donoghue M N. Update on photoprotection[J]. Dermatol Ther, 2007, 20: 360-376. pmid: 18045361
[15]	Avenel-Audran M, Dutartre H, Goossens A, et al. Octocrylene, an emerging photoallergen[J]. Arch Dermatol, 2010, 146: 753-757. doi: 10.1001/archdermatol.2010.132 pmid: 20644036
[16]	Manová Eva, von Goetz Natalie, Hauri Urs, et al. Organic UV filters in personal care products in Switzerland: a survey of occurrence and concentrations[J]. International Journal of Hygiene and Environmental Health, 2013, 216 (4) : 508-514. doi: 10.1016/j.ijheh.2012.08.003 pmid: 23026542
[17]	Wang Gangli, Zhang Qingsheng. Comparison of global cosmetics technical regulations[M]. Beijing: People’s Medical Publishing House, 2018: 554-560.
[18]	Chen Weier. Analysis on the market position of korean cosmetics in China[J]. China Business, 2016 (25) : 16-17.
[19]	Zeng Huimin. Analysis on the development of korean cosmetics in China[J]. China Market, 2017 (17) : 131-132, 147.

国家	韩国	日本	美国	法国	瑞士等欧洲国家	泰国等亚洲国家	大洋洲
批件数量/件	1 647	424	374	315	193	85	19
占比/%	53.9	13.9	12.2	10.3	6.3	2.8	0.6

年份	批件数量/件	SPF范围	中位数
2017年	250	10~50+	40
2018年	263	10~50+	40
2019年	260	10~50+	45
2020年	118	9~50+	42
2021年	47	9~50+	41

年份	PFA值
	PA+			PA++			PA+++			PA++++
		批件数量	占比		批件数量	占比		批件数量	占比		批件数量	占比
2017年	1件	0.5%		73件	37%		113件	57%		10件	5%
2018年	2件	0.9%		81件	36%		122件	53%		23件	10%
2019年	1件	0.4%		74件	31%		110件	46%		53件	22%
2020年	1件	1%		26件	25%		49件	47%		28件	27%
2021年	0	0		14件	34%		17件	41%		10件	24%

剂型	主要化妆品种类	批件数量/件	占比/%
膏霜乳	防晒膏、乳液、霜、粉底液、气垫、精华类	2 620	86
粉剂	散粉、粉饼、防晒粉	256	8
蜡基	口红、唇膏	107	4
喷雾、气雾	防晒喷雾和防晒气雾剂	88	3

防晒剂	批件数量/件	使用频率
甲氧基肉桂酸乙基己酯	2 038	66.7%
水杨酸乙基己酯	989	32.4%
双-乙基己氧苯酚甲氧苯基三嗪	727	23.8%
二乙胺羟苯甲酰基苯甲酸己酯	613	20.1%
奥克立林	580	19.0%
苯基苯并咪唑磺酸	393	12.9%
丁基甲氧基二苯甲酰基甲烷	393	12.9%
胡莫柳酯	308	10.0%
二氧化钛	198	6.5%
氧化锌	175	5.7%
乙基己基三嗪酮	175	5.7%
二苯酮-3	122	4.0%
4-甲基苄亚基樟脑	94	3.1%
对甲氧基肉桂酸异戊酯	90	2.9%
聚硅氧烷-15	88	2.9%
甲酚曲唑三硅氧烷	49	1.6%
二乙基己基丁酰胺基三嗪酮	22	0.7%
亚甲基双-苯并三唑基四甲基丁基酚	22	0.7%
二苯酮-4	2	0.1%