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China,Cosmetics,Inspection,Results,CFDA

From January 9 to March 21, 2018, the China Food and Drug Administration successively issued results of random inspections of hair dyeing cosmetics:

▪ CFDA notice on the disqualified hair dyeing cosmetics of 35 batches (No. 2, 2018)

▪ CFDA notice on the disqualified hair dyeing cosmetics of 80 batches (No. 24, 2018)

▪ CFDA notice on the disqualified hair dyeing cosmetics of 62 batches (No. 32, 2018)

▪ CFDA notice on the disqualified hair dyeing cosmetics of 70 batches (No. 33, 2018)

▪ CFDA notice on the disqualified hair dyeing cosmetics of 85 batches (No. 49, 2018)

▪ CFDA notice on the disqualified hair dyeing cosmetics of 88 batches (No. 52, 2018)

At the same time, the results of spot check on cosmetics for anti-freckle/whitening and anti-acne released：

▪ CFDA notice on the disqualified cosmetics for anti-freckle/whitening of 29 batches (No. 20, 2018)

▪ CFDA notice on the disqualified cosmetics for anti-acne of 21 batches (No.42, 2018)

CIRS summarized the inspections results of CFDA, Fujian FDA, and Henan FDA in the first quarter of 2018.

Table 1：Sampling results of cosmetics by the CFDA in Q1 2018 (Hair dyeing)

Unqualified products	Sampling sour ce	Unqualified products source	Unqualified items
35	Heilongjiang Sichuan Shandong Liaoning Hebei Guizhou	Hebei1 Guangdong7 Shandong3 Liaonig5 Beijing7 Jiangsu1 Zhejiang11	▪Detect the hair dye agent without indicating on the approval license or label; ▪Not detect the hair dye agent showed on the approval license or the label; ▪Inconsistent hair dye agent between the approval formula of the license and the product label; Notes: a counterfeit product found in on-site verification.
80	Liaoning Shanxi Guizhou Heilongjiang Shanghai Shanxi Hebei Inner Mongolia Guangxi Shandong	Fujian6/Shanghai8 Zhejiang16/Guangdong50	▪Labeling info is inconsistent with the approval license； ▪ Not detect the hair dye agent showed on the approval license or the label; ▪ Detect the hair dye agent without indicating on the approval license or label, and the content exceeds limit level; ▪ Detect the forbidden components; ▪ The Dyes and oxidants showed oppositely on approval license; ▪The product name and color on the label do not match the approved license; ▪Mix ratio with oxidized agent is 1:1； ▪The shelf life on the label not consistent with the approval license; Notes: 19 counterfeit products found in on-site verification.
62	Liaoning Shanghai Sichuan Gansu Hebei Inner Mongolia Guangxi Jilin Anhui Xinjiang Jiangxi Tianjin Guangdong Fujian	Guangdong59 Zhejiang3	▪ Detect the hair dye agent without indicating on the approval license or label, and the content exceeds limit level; ▪ Detect the forbidden components; ▪ Not detect the hair dye agent showed on the approval license or the label; ▪Labelling info is not clear for containing ingredient; ▪The product name on the label do not match the approved license; Notes: 4 unqualified products after retest by CFDA designated lab. 14 counterfeit products found in on-site verification.
70	Xinjiang Guangdong Jilin Tianjin Anhui Fujian Hubei	Fujian2 Liaoning2 Shanghai2 Beijing2 Xinjiang4 Zhejiang10 Guangdong48	▪Labeling info is inconsistent with the approval license; ▪ Not detect the hair dye agent showed on the approval license or the label; ▪ Detect the hair dye agent without indicating on the approval license or label, and the content exceeds limit level; Notes: An enterprise has been shut down and 7 counterfeit products found in on-site verification by provincial FDA.
85	Heilongjiang Liaoning Shanxi Xizang Gansu Jiangxi Gansu Guizhou Guangxi Inner Mongolia	Jiangsu2 Zhejiang21 Guangdong62	▪ Not detect the hair dye agent showed on the approval license or the label; ▪Detect the hair dye agent without indicating on the approval license or label ▪Inconsistent labelling info and approval formula; ▪No main ingredient info on the label; ▪The component is ambiguous on the label; ▪Production and expiration date do not match the actual situation; Notes: 2 unqualified products after retest by CFDA designated lab.
88	Xinjiang Shandong Gansu Jiangxi Anhui Jilin Hubei Shanxi Xizang Guangxi Sichuan Shanxi Tianjin Zhejiang	Jiangsu1 Zhejiang13 Guangdong74	▪ Detect the hair dye agent without indicating on the approval license or label, and the content exceeds limit level; ▪ Not detect the hair dye agent showed on the approval license or the label; ▪Inconsistent labelling info and approval formula; ▪No main ingredient info on the label; ▪No labelling and approval formula found； ▪The product color on the package inconsistent with the approval license； ▪Production and expiration date do not match the actual situation; ▪ Detect the forbidden components; Notes; 2 unqualified products after retest by CFDA designated lab. A counterfeit product found in on-site verification.

Table 2：Sampling results of cosmetics by the CFDA in Q1 2018 (Anti-freckle / anti-acne)

Un qualified products	Sampling source	Unqualified products source	Unqualified items
29	Inner Mongolia Chongqing Yunnan Qinghai Xinjiang Guangxi Xizang	Beijing1 Guangdong28	Triamcinolone Acetate / Mercury / Betamethasone Acetate / Clobetasol propionate / Triamcinolone / Betamethasone / Betamethasone valerate Notes: 12 counterfeit products found and 8 company addresses cannot be found after on-site verification;.
21	Jiangsu Shandong Heilongjiang Qinghai Xizang Shanxi Ningxia Guangdong Tianjin Xinjiang Hunan Chongqing Hainan	Hongkong1 Guangdong15 Shanghai1 Zhejiang3 Fujian1	Metronidazole / Chloramphenico l/ Ketoconazole / Bifonazole / Clotrimazole / Ofloxacin / Miconazole / Ciclopiroxamine Notes: 4 unqualified products after retest by CFDA designated lab; 12 counterfeit products found in on-site verification; As checked by the provincial FDA, 1 company claimed that the product was only tried but not for sale, the production record of one product could not be provided because of the change of shareholdings and the employees left the company, and 1 company address cannot be found.

Table 3：Sampling results of cosmetics by Fujian FDA in Q1 2018

Sample product type	Unqualified products	Sampling source	Unqualified items
Skincare / shampoo for hair growth	3	Big Pharmacy/Beauty Salon Store	Dexamethasone / Total number of colonies

Table 4：Sampling results of cosmetics by Henan FDA in Q1 2018

Sample product type	Unqualified products	Sampling source	Unqualified items
Acne products	1	Beauty salon	Metronidazole

CIRS summary

1) As tables 1 and 2 shows, the CFDA conducted at least 8 random inspections of commercial cosmetics in the first quarter, of which 6 were for hair dye products, and the rest were for anti-freckle/whitening and anti-acne. Guangdong, Shanghai, and Zhejiang provinces are the focus of China cosmetics manufacturers, so the production of substandard products also comes mainly from these regions.

2) Hair dye products need to be approved by the CFDA before placed on the China market, but there are still illegal situation appeared, like detecting hair dye agent without indicating on the approval license or label and forbidden components, or not detecting hair dye agent showed on the approval license or the label, etc.

3) The behavior that the cosmetic manufacturers change their product formulas without authorization violates the Regulations Concerning the Hygiene Supervision of Cosmetics and the Regulations on the Administration of Cosmetics Labelling. There is a risk of not achieving the desired hair dyeing effect or causing skin allergies. A large part of the unqualified sampling hair dyeing products were counterfeit products, and the test results of some products were still not qualified after retest.

4) The mercury, triamcinolone acetonide, triamcinolone acetonide, betamethasone, betamethasone acetate, betamethasone valerate, clobetasol propionate and other banned ingredients were detected in substandard anti-freckle/whitening products.

5) The CFDA requires all cosmetic companies to stop the sale of above products. And the provincial (municipal) FDA will, after verification, supervise the relevant cosmetics manufacturers to adopt recalls promptly and other measures for marketed products, and initiate investigations, handle them in accordance with the law. Relevant info will be disclosed timely.

6) Tables 3 and 4 are the sample inspections of Fujian and Henan FDA respectively in the first quarter of 2018. There are unqualified products with banned hormones, excessive microorganisms, or antibiotics.

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Sources:

http://www.sda.gov.cn/WS01/CL1753/226778.html

http://www.sda.gov.cn/WS01/CL1753/226426.html

http://www.sda.gov.cn/WS01/CL1753/225525.html

http://www.sda.gov.cn/WS01/CL1753/224868.html

http://www.sda.gov.cn/WS01/CL1753/224867.html

http://www.sda.gov.cn/WS01/CL1753/224217.html

http://www.sda.gov.cn/WS01/CL1753/223663.html

http://www.sda.gov.cn/WS01/CL1753/222089.html

http://www.sda.gov.cn/WS01/CL1754/226081.html

http://www.sda.gov.cn/WS01/CL1754/225186.html

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Summary of Sampling Results of Cosmetics in Q1 2018