NMPA Notice on 28 batches of Unqualified Cosmetic Products - Regulatory News - Personal and Home Care Products

Cosmetic,China,Unqualified Cosmetic Products,Regulation,Hygiene License

On September 25th, 2018, National Medical Products Administration (NMPA) issued a notice on the inspection results of 28 batches of unqualified cosmetics produced by 21 manufacturers including the Laidan fine chemical factory in Baiyun district, Guangzhou. The result in detail could be referred to Table 1 below. The inspection this time is mainly for hair dye products produced by manufacturers from Guangdong province, as well as Zhejiang, Beijing and Liaoning province.

According to Regulations Concerning the Hygiene Supervision over Cosmetics, hair dye products belong to special use cosmetics, which could be sold after the issue of hygiene license. In Accordance with the regulations on acceptance of hygiene license of cosmetics, it is required to apply for license as a new product once there're changes on the formula of cosmetics or changes involving safety issues. Due to safety concern, some of the banned substances have been adjusted in Safety and Technical Standards for Cosmetics (2015 vision). 2-aminophenol, a permitted hair dye in Hygienic Standards for Cosmetics (2007 vision), became a banned substance in the 2015 vision. The main problem of the unqualified hair dye products discovered via the inspection is that the actual detected ingredients are not consistent with the approved formula or label identification, which is considered as an action of changing product formula without authorization. The licenses of a few products have expired. The banned substance 2-aminophenol and other unlabeled hair dyes such as phenyl methyl pyrazolone, 2-amino-3-hydroxypyridine, 4-Chlororesorcinol, etc, were detected in several batches of products, which violated relevant regulations.

NMPA had required the FDA of Guangdong, Liaoning, Beijing and Zhejiang province (cities) to order relevant manufacturers to recall failed products and to inspect those manufacturers. Local FDAs were required by NMPA to deal with the above companies seriously in accordance with laws and to disclose relevant information in time.

Table 1：Detailed info of unqualified cosmetics products

Company name of sampling	Product name	Unqualified item
廣州市白云區萊丹精細化工廠	索菲雅染發膏（自然黑）	1.No sample label info； 2.Unlabeled hair dye detected：M-aminophenol and phenylpyrazolone； 3. Labeled hair dye undetected：2, 4-diaminobenoxyethanol hydrochloride


廣州市卡迪娜化妝品廠	卡迪娜染發膏(金黃色)	1. Inconsistence between product license and label identification； 2. Unlabeled hair dye detected: 2-aminophenol, p-aminophenol. 3. Labeled hair dye undetected: 4-Chlororesorcinol, resorcinol, m-aminophenol.




廣州歌秀化妝品有限公司	愈美染發膏	1. Unlabeled hair dye detected: p-phenylenediamine, p-aminophenol. 2. Labeled hair dye undetected: Toluene-2, 5-diamine sulfate.


廣東瑞虎精細化工有限公司	瑞虎染得快染發膏（栗棕色）	Banned substance detected: ortho-aminophenol.
廣東圣薇娜精細化工有限公司	然你魅4/66圣薇娜彩色焗油（紅色）	· 1. Unlabeled hair dye detected: p-phenylenediamine, toluene-2, 5-diamine sulfate, N,N- double (2-hydroxyethyl) p-phenylenediamine sulfate. 2. Labeled hair dye undetected: 1-naphthol



廣州麗臣精細化工有限公司	麗臣染發膏（板栗色）	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: p-phenylenediamine, p-aminophenol, m-aminophenol. 4-amino-2-hydroxytoluene. 3. Labeled hair dye undetected: 2, 4-diaminobenoxyethanol hydrochloride, 4-amino-cresol.





廣州市金栢麗保健品有限公司	干戀染發膏（自然黑）	1. Unlabeled hair dye detected: Resorcinol, phenyl methylpyrazolone. 2. Labeled hair dye undetected: 2-methylresorcinol


廣州市蘭姿化妝品有限公司	海維斯染發焗油膏（自然黑）	1. Unlabeled hair dye detected: m-aminophenol, phenyl methylpyrazolone 2. Labeled hair dye undetected: 4-amino-2-hydroxytoluene, 2, 4-diaminobenoxyethanol hydrochloride



廣州市凱維斯化妝品有限公司	凱維斯染發膏（紫紅色）	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: P-phenylenediamine, 4-amino-2-hydroxytoluene, 4-amino-2-hydroxytoluene, 2-methyl resorcinol 3. Labeled hair dye undetected: phenyl methylpyrazolone,N,N- bi (2-hydroxyethyl) p-phenylenediamine sulfate, resorcinol





廣州威妮雅化妝品有限公司	金竹堂染發膏（酒紅）	1. Inconsistence between product license and label identification； 2. Unlabeled hair dye detected: 4-amino-2-hydroxytoluene, 1-naphthol, 2, 4-diaminobenoxyethanol hydrochloride 3. Labeled hair dye undetected: p-aminophenol, N,N- bi (2-hydroxyethyl) p-phenylenediamine sulfate p-aminophenol




鶴山市邦麗精細化工有限公司	夢佩絲染發膏（紅色）	Labeled hair dye undetected: m-aminophenol
廣州溫雅日用化妝品有限公司	溫雅漾采染發焗油（5B）咖啡色	1. Unlabeled hair dye detected: Phenyl methyl pyrazolone, 2, 4-diaminobenoxyethanol hydrochloride 2. Labeled hair dye undetected: N,N- bi (2-hydroxyethyl) p-phenylenediamine sulfate p-aminophenol


中山佳麗日用化妝品有限公司	利威絲染發霜（栗棕色）	1. Unlabeled hair dye detected: M-aminophenol, m-phenol, 6-amino-cresol, 2-amino-3-hydroxypyridine 2. Labeled hair dye undetected: P-aminophenol, 4-amino-2-hydroxytoluene, 2-methylresorcinol






廣州市美度化妝品有限公司	美度染發膏（棕黑色）44/0	1. Hair dye unlabeled 2. Unlabeled hair dye detected: P-aminophenol, m-aminophenol, o-aminophenol 3. Labeled hair dye undetected: 2, 4-diaminobenoxyethanol hydrochloride



	美度染發膏（酒紅色）S-5/64	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: P-phenylenediamine 1- naphthol 3. Labeled hair dye undetected: 2, 4-diaminobenoxyethanol hydrochloride


廣州市白云區圣迪雅化妝品廠	益容堂染發膏（葡萄紅）	1. Inconsistence of shelf life on product license and label identification 2. Unlabeled hair dye detected: Toluene - 2,5 - diamine sulfate, 1- naphthol, p-phenylenediamine, p-aminophenol, 4-amino-2-hydroxytoluene 3. Labeled hair dye undetected: M-aminophenol, o-aminophenol, m-phenyldiphenol, 2, 4-diaminobenoxyethanol hydrochloride,N, n-bi (2-hydroxyethyl) p-phenylenediamine sulfate, 2, 4-diaminobenoxyethanol hydrochloride









	益容堂染發膏(自然黑)	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: P-phenylenediamine, m-aminophenol, m-phenyldiphenol, 2, 4-diaminobenoxyethanol hydrochloride； 3. Labeled hair dye undetected: 1-naphthol, phenyl methylpyrazolone





廣州市漢邦化妝品有限公司	昌義潤黑露染發膏（自然黑色）	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: Phenyl methyl pyrazolone, 2, 4-diaminobenoxyethanol hydrochloride

	昌義漢邦染發膏（自然黑色）	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: Phenyl methyl pyrazolone, 2, 4-diaminobenoxyethanol hydrochloride

	漢邦染發膏（棕色5.4)	1. Banned substance detected: o-aminophenol 2. Unlabeled hair dye detected: Phenyl methylpyrazolone, 2-amino-3-hydroxypyridine 3. Labeled hair dye undetected: M-aminophenol



廣州嘉瀛化妝品有限公司	嘉瀛染發膏（棕色）	1. Inconsistence of shelf life on product license and label identification； 2. Unlabeled hair dye detected: P-aminophenol, m-aminophenol, p-aminophenol 3. Labeled hair dye undetected: Toluene-2, 5-diamine sulfate, 2, 4-diaminophenylphenoxyethanol hydrochloride,N, n-double (2-hydroxyethyl) p-benzodiazepine sulfate, 1-naphthol





	嘉瀛染發膏（棕色）	1. Inconsistence of shelf life on product license and label identification 2. Unlabeled hair dye detected: 2, 4-diaminobenoxyethanol hydrochloride, 2,4- diaminophenyl alcohol hydrochloride,N,N- bi (2-hydroxyethyl) p-phenylenediamine sulfate 3. Labeled hair dye undetected: P-phenylenediamine, resorcinol



	嘉瀛染發膏（紅色）	1. Inconsistence of shelf life on product license and label identification 2. Unlabeled hair dye detected: P-phenylenediamine, toluene 2, 5-diamine sulfate, m-aminophenol, m-phenyldiphenol, 2, 4-diaminobenoxyethanol hydrochloride,N, n-bi (2-hydroxyethyl) p-phenylenediamine sulfate, 1-naphthol






大連河原日用化學品有限公司；北京順捷彩悅化妝品有限公司監制	彩蘊焗油染發膏天然黑	1.License expired and no formula info； 2. Unlabeled hair dye detected: 4-chloro-resorcinol
北京日光旭升精細化工技術研究所	珍草堂彩染焗油膏（自然黑色）	1. Unlabeled hair dye detected: P-phenylenediamine, m-aminophenol, phenyl pyrazolone, 2, 4-diaminobenoxyethanol hydrochloride 2. Labeled hair dye undetected: N,N- double (2-hydroxyethyl) p-phenylenediamine sulfate




北京日光旭升精細化工技術研究所；委托方：北京九州益華化妝品有限公司	珍草堂彩染焗油膏（栗棕色）	1. Unlabeled hair dye detected: P-phenylenediamine, m-aminophenol, phenyl methylpyrazolone 2. Labeled hair dye undetected: N,N- double (2-hydroxyethyl) p-phenylenediamine sulfate



浙江章華保健美發實業有限公司	章華漢草焗油染發霜	Unlabeled hair dye detected: 1, 5 - naphthalene hydroquinone
廣州市彩琳日用化工有限公司	彩琳®美白保濕防曬露SPF30+PA+++	Incorrect production date

Reference

NMPA Notice on 28 batches of unqualified cosmetic products

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