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China,CFDA,Cosmetics,Sample,Check,2017

In 2017, CFDA carried out continuous random sample check for commercially available cosmetic products to strengthen the implementation of new regulations such as the labeling requirements for sunscreen products. CIRS summarized and analyzed the results of the random sample checks conducted by CFDA, and FDAs of Guangdong, Shanghai and Zhejiang in 2017.

Throughout the year, CFDA has carried out at least 14 random sample checks (see table 1): 12 of which are for sunscreen products, and the other 2 for masks and skin care products with anti-acne claiming. The sample check performed in the cities across the country, but most of them were in the northern and western areas. Since Guangdong, Shanghai and Zhejiang have the majority numbers of cosmetic manufacturers, the production of disqualified products mainly come from these areas.

Disqualified anti-acne products mostly contain prohibited antibiotics, and hormones such as Ofloxacin, Metronidazole and Chloramphenicol. Disqualified masks contains glucocorticoids such as Clobetasol Propionate, Betamethasone 17-Valerate, Fluocinolone Acetonide, Betamethasone and Dexamethasone. Long term using cosmetics containing glucocorticoids may induce production of blackspot, skin atrophy and thinning, as well as other consequences like steroid-dependent dermatitis. Glucocorticoids are regarded as banned cosmetic ingredients according to the Safety and Technical Standards for Cosmetics (2015).

Sunscreen products have to obtain CFDA’s administrative license before marketing. However, there are still undesirable phenomena including 1) products with sunscreen agents on submitted formulas but not detected, 2) products with detected sunscreen agents but not on submitted formula and labels, 3) inconsistent product names on the license and 4) sample packaging, products still being sold after the expiration of the license, and 5) inconsistent testing results for 3 independent samples with the same batch number of one product.

A large proportion of disqualified sunscreen products are bogus products. CFDA commands all cosmetic companies to stop selling all disqualified products. After examining, relevant provincial (municipality) FDA should urge related enterprises (manufacturers/agencies) to take steps according to law, including recall of the products that are already on the market, file and investigate, punish seriously, and disclose relevant information in time. Products with only labeling that are not in accordance with regulations can be sold after the relevant manufacturers/agencies complete modifications in a limited time period ordered by FDAs. Regarding suspected bogus products, the local FDAs should deeply trace and investigate the supply channels of relevant enterprises, strike hard on the activity of producing and selling bogus and shoddy cosmetics, and transfer suspected crimes to the Public Security Department.

CIRS has also summarized sample checking results from Guangdong (table 2), Shanghai (table 3) and Zhejiang (table 4) FDA in all 4 quarters in 2017. It can be seen that the products being randomly checked by Guangzhou FDA are mainly skin care products with anti-acne and anti-freckle claiming and creams. Shanghai FDA selected and randomly checked skin care, hair care products and hair dyes in large quantity sample bases (>500) with low rate of disqualification. Zhejiang FDA selected different product categories for each quarter with sample quantity normally around 150 for skin care products with claiming like anti-acne and whitening, and other products such as masks. The above disqualified products all contain banned antibiotics, hormones, and exceeding content of Hg and microorganisms. Microbial contamination affects not only the product quality itself, but also the health and safety of consumers.

On 1 st March 2017, a new record-keeping system for import non-special use cosmetic products has been implemented in Shanghai Pudong New Area. The pilot system altered the original administrative approval to on- and post-market surveillance. Compared to administrative approval, the post-market surveillance is more stringent. In the future, CFDA and local FDAs will gradually improve the supervision and punishment system of cosmetic manufacturers; at the same time improve market competition of domestically produced products. CIRS suggests enterprises to be prepared in advance to cope with any further regulatory changes.

Table 1. Summary of Random Sample Check by CFDA, 2017

No. of Random Sample Check	Product Category	Disqualified Products	Sample Check Location	Production Origin of Disqualified Products	Disqualified Items	Remark
1	Anti-acne Sample quantity: 2717	29	Gansu, Hainan, Heilongjiang, Hubei, Hunan, Liaoning, Qinghai, Shanxi, Sichuan, Xizang, Xinjiang, Yunnan, Zhejiang	Guangdong: 26; Shanghai: 2; Gansu: 1	Containing Ofloxacin, Metronidazole and Chloramphenicol.
2	Sunscreen	5	Liaoning, Heilongjiang, Jilin	Guangdong: 4; Tianjin: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected.	Including 2 imported products
3	Sunscreen	12	Jilin, Heilongjiang, Liaoning, Guizhou	Guangdong: 11; Zhejiang: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Inconsistent product names on the license and sample packaging; License expired.	Including 1 imported product; After on-site inspection, 3 of the products are suspected bogus products.
4	Sunscreen	9	Jilin, Liaoning, Heilongjiang, Shanxi	Guangdong: 9	Sunscreen agent on submitted formula and label but not detected; Inconsistent sunscreen agents on submitted formula and label; License expired with inconsistent product names on license and product packaging; Inconsistent product names on license and sample packaging.	After on-site inspection, 1 of the products is suspected bogus product.
5	Sunscreen	10	Shandong, Anhui, Yunnan, Gansu, Inner Mongolia	Beijing: 1; Guangdong: 8; Shanghai: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; License expired with inconsistent product names on license and product packaging.	Including 1 imported product; After on-site inspection, 4 of the products are suspected bogus products.
6	Sunscreen	15	Yunnan, Gansu, Anhui, Inner Mongolia	Guangdong: 13; Shanghai: 1; Zhejiang: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Inconsistent product names on license and sample packaging or license has expired.	Including 2 imported products; After on-site inspection, 1 of the products is suspected bogus product; 1 of the disqualified product has started to be recalled from market
7	Sunscreen	18	Ningxia, Sichuan, Hebei, Xinjiang, Zhejiang	Shanghai: 2; Guangdong: 15; Beijing: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Submitted formula missing (empty technical specification on license); Inconsistent product names on license and sample packaging.	After on-site inspection, 1 of the products is suspected bogus product.
8	Sunscreen	28	Fujian, Guangxi, Xinjiang, Shanxi, Gansu, Ningxia, Sichuan, Guangdong, Shandong, Hainan, Yunnan	Zhejiang: 2; Guangdong: 26	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Submitted formula missing (inconsistent product names on license and sample packaging); Inconsistent product names with product packaging.
9	Sunscreen	25	Shandong, Fujian, Guangxi, Ningxia, Chongqing, Henan, Hunan, Xizang, Xi’an	Shanghai: 1; Suzhou: 2; Guangdong: 22	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected.	After on-site inspection, 12 of the products are suspected bogus products; 1 product is suspected to have fake production date.
10	Sunscreen	24	Shandong, Xinjiang, Qinghai, Shanxi, Xi’an, Xizang, Chongqing, Hebei	Beijing: 1: Shanghai: 2; Guangdong: 19; Xianggang: 1; Qinghai: 1	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Inconsistent product names on license and sample packaging.	Including 2 imported products, and 1 of which is with no Chinese ingredient list; After on-site inspection, 8 of the products are suspected bogus products; 2 products are suspected to have fake production dates.
11	Sunscreen	13	Xi’an, Shandong, Guangdong, Hainan, Hebei, Henan	Shanghai: 2; Guangdong: 11	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Submitted formula missing or license has expired; Inconsistent testing results for 3 independent samples with the same batch number of one product.	Including 1 imported products; After on-site inspection, 5 of the products are suspected bogus products.
12	Sunscreen	20	Qinghai, Ningxia, Shandong, Xizang, Chongqing, Xinjiang, Zhejiang, Sichuan, Shanxi	Shanghai: 1; Guangdong: 19	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected; Submitted formula missing or inconsistent product names on license and packaging.	After on-site inspection, 8 of the products are suspected bogus products; Inconsistent batch number on out packaging and on minimum packaging
13	Sunscreen	4	Jiangxi, Xizang, Xi’an, Chonqing	Guangdong: 4	Sunscreen agent detected but not on submitted formula and label; Sunscreen agent on submitted formula and label but not detected.	After re-inspection, 2 of the products are still judged to be disqualified.
14	Mask Sample quantity: 3727	23	Jilin, Inner Mongolia, Xinjiang, Shaanxi, Liaoning, Sichuan, Heilongjiang, Jiangxi, Guangdong, Hubei	Guangdong: 16; Shanghai: 7	Containing Clobetasol Propionate, Betamethasone 17-Valerate, Fluocinolone Acetonide, Betamethasone and Dexamethasone	After on-site inspection, 16 of the products are suspected bogus products; Hygiene License for cosmetics manufacturer has expired or cancelled, or no manufacturer on label

Table 2. Summary of Random Sample Check by Guangdong FDA, 2017

No. of Random Sample Check	Product Cate gory	Disqualified Products	Production Origin of Disqualified Products	Disqualified Items
1	Skin care products (anti-freckle, anti-acne, mask, facial cream)	67	Commodity store/department store/pharmacy/cosmetics store	Hg, Betamethasone, Betamethasone 17-Valerate, Clobetasol Propionate, Ofloxacin, Chloramphenicol, Metronidazole, Dexamethasone, Mometasone Furoate, Triamcinolone Acetonide and Triamcinolone Acetonide Acetate
2	Skin care products (anti-freckle, anti-acne, facial cream)	45	Commodity store/pharmacy/cosmetic store/beauty salon/department store/barber shop	Hg, Chlorphenamine, Diphenhydramine, Ofloxacin, Hydroquinone, Metronidazole, Dexamethasone, Betamethasone, Betamethasone 17-Valerate, Dexamethasone Acetate, Chloramphenicol, Clobetasol Propionate

Table 3. Summary of Random Sample Check by Shanghai FDA, 2017

No. of Random Sample Check	Product Category	Disqualified Products	Production Origin of Disqualified Products	Disqualified Items
1	Skin care products (hand care, cleanser, cream for children, hair dye)	7	Pharmacy/hotel/supermarket/cosmetic company	Total number of colony, Clobetasol Propionate, Acrylamide, 2,6-Diaminopyridine, Isopropyl 4-hydroxybenzoate (by p-Hydroxybenzoic acid content)
2	Mask	1	Supermarket	Total number of colony
3	Hair care, essence	4	Cosmetic company	Total number of colony, Methanol

Table 4. Summary of Random Sample Check by Zhejiang FDA, 2017

No. of Random Sample Check	Product Category	Disqualified Products	Production Origin of Disqualified Products	Disqualified Items
1	Skin care product (mask)	13	Beauty salon/cosmetic store/supermarket/commodity store	Fluocinolone Acetonide, Clobetasol Propionate, total number of mould and yeast, Dexamethasone, Clobetasol Butyrate, Phenol
2	Skin care product (anti-acne)	9	Cosmetic store/beauty salon/commodity store/food supplement store	Metronidazole, Chloramphenicol, Hydrocortisone, Ketoconazole, Dexamethasone Acetate, Clobetasol Propionate, Ofloxacin
3	Skin care product (Anti-freckle)	2	Cosmetic store	Hg

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Result Summary of Random Sample Check for Cosmetics on the Market, 2017