NMPA Notice on 28 batches of Unqualified Cosmetic 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

广州市白云区莱丹精细化工厂

索菲雅染发膏(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

广州市卡迪娜化妆品厂

卡迪娜染发膏(金黄色)

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.

广州歌秀化妆品有限公司

愈美染发膏

1. Unlabeled hair dye detected: p-phenylenediamine, p-aminophenol.
2. Labeled hair dye undetected: Toluene-2, 5-diamine sulfate.

广东瑞虎精细化工有限公司

瑞虎染得快染发膏(栗棕色)

Banned substance detected: ortho-aminophenol.

广东圣薇娜精细化工有限公司

然你魅4/66圣薇娜彩色焗油(红色)

·         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

广州丽臣精细化工有限公司

丽臣染发膏(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.

广州市金栢丽保健品有限公司

干恋染发膏(自然黑)

1. Unlabeled hair dye detected: Resorcinol, phenyl methylpyrazolone.
2. Labeled hair dye undetected: 2-methylresorcinol

广州市兰姿化妆品有限公司

海维斯染发焗油膏(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

广州市凯维斯化妆品有限公司

凯维斯染发膏(紫红色)

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

广州威妮雅化妆品有限公司

金竹堂染发膏(酒红)

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

鹤山市邦丽精细化工有限公司

梦佩丝染发膏(红色)

Labeled hair dye undetected: m-aminophenol

广州温雅日用化妆品有限公司

温雅漾采染发焗油(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

中山佳丽日用化妆品有限公司

利威丝染发霜(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

广州市美度化妆品有限公司

美度染发膏(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

美度染发膏(酒红色)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

广州市白云区圣迪雅化妆品厂

益容堂染发膏(葡萄红)

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

益容堂染发膏(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

 

广州市汉邦化妆品有限公司

昌义润黑露染发膏(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

昌义汉邦染发膏(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

汉邦染发膏(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

广州嘉瀛化妆品有限公司

嘉瀛染发膏(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

嘉瀛染发膏(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

嘉瀛染发膏(红色)

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

大连河原日用化学品有限公司;                北京顺捷彩悦化妆品有限公司监制

彩蕴焗油染发膏 天然黑

1.License expired and no formula info;
2. Unlabeled hair dye detected: 4-chloro-resorcinol

 

北京日光旭升精细化工技术研究所

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

北京日光旭升精细化工技术研究所;  
委托方:北京九州益华化妆品有限公司

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

浙江章华保健美发实业有限公司

章华汉草焗油染发霜

Unlabeled hair dye detected: 1, 5 - naphthalene hydroquinone

广州市彩琳日用化工有限公司

彩琳®美白保湿防晒露SPF30+PA+++

Incorrect production date

Reference

NMPA Notice on 28 batches of unqualified cosmetic products