SFDA to Approve another 4 Testing Institutions for Cosmetics

Nov. 16th, 2012
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Pursuant to Article 3 of Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions, there are two types of institutions:

  • hygiene safety testing institution to perform all microbiological, hygienic chemical and toxicological tests;
  • human safety testing institutions to conduct human safety tests (including human skin patch test and using test) and cosmetic sunscreens efficacy test.

According to the announcement No. 18 and No. 86 of 2011, last year saw 17 units in total approved as hygiene safety testing institutions and 6 units as human safety testing institutions. The new four units are incorporated into the first type.

Every unit bears a unique serial number. SFDA will supervise the testing quality by requiring monthly and annual reports from institutions, in addition to non-scheduled on-site inspections.

Table 1: List of SFDA-approved testing institutions for cosmetics

Type Testing Institution Serial Number
Hygiene safety testing institution

(microbiological test, hygienic chemical test,

toxicological test)

Institute of Environmental Health

and Related Product Safety, China CDC

001
Beijing CDC 002
Liaoning CDC 003
Shanghai CDC 004
Jiangsu CDC 005
Zhejiang CDC 006
Guangdong CDC 007
Sichuan CDC 008
Beijing institute for Drug Control 014
Shanghai institute for Food and Drug Control 015
Guangdong institute for Drug Control 016
Zhejiang Institute for Food and Drug Control 018
Shandong Institute for Food and Drug Control 019
Fujian Provincial Institute for Drug Control 020
Guangzhou Institute for Drug Control 021
Shenzhen Institute for Drug Control 022
Hubei Provincial Center for Disease Control and Prevention 023
National Institute for Food and Drug Control 024
Liaoning Institute for Food and Drug Control 025
Guangxi Institute for Food and Drug Control 026
Xiamen Institute for Drug Control 027
Human safety testing institutions

(human safety test and test in vivo of UV protection efficacy of cosmetic sunscreens)

General Hospital of Chinese People’s Liberation Army Air Force 009
Shanghai Skin Disease Hospital 010
The third Affiliated Hospital of San Yat-sen University 011
West China Hospital of Sichuan University 012
The first hospital of China Medical University 013
kin Disease Hospital of Chinese Academy of Medical Sciences 017

Table 2: Compulsory testing items of  hygiene safety testing institutions

Testing Category Compulsory Testing Item
Microbiological Aerobic bacterial count
Fecal coliforms
Staphylococcus aureus
Pseudomonas aeruginosa
Molds and yeast count
Hygienic chemical Mercury
Arsenic
Lead
Methanol
PH
Formaldehyde
Thioglycollic Acid
Hydroquinone and Phenol
Chlormethine and Cantharidin
Sexual Hormones
UV filters
Oxidative Hair Dyes
α-Hydroxy Acid
Antidandruff agent
Antibiotics
Toxicological Acute oral toxicity test
Acute dermal toxicity test
Skin irritation/corrosion test
Eye irritation/corrosion test
Skin sensitization test
Skin phototoxicity test
Salmonella typhimurium/reverse mutation assay
In Vitro Mammalian Cells Chromosome Aberration Test
In Vitro Mammalian Cell Gene Mutation Test

Table 3: Optional testing items of hygiene safety testing institutions

Testing Category Optional Testing Item
Hygienic chemical Anti UVA parameter-critical wavelength
Free Hydroxide
Cadmium
Total Selenium
Boric Acid and Borate
Selenium Disulfide
Preservatives
Vitamin D2, Vitamin D3
Dissolvable zinc salt
Toxicological In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test
Mammalian Erythrocyte Micronucleus Test
Testicle Cells Chromosome Aberration Test
Subchronic Oral Toxicity Test
Subchronic Dermal Toxicity Test
Teratogenicity Test
Combined Chronic Toxicity/Carcinogenicity Test
Metabolic toxicity test

Table 4: Testing items of human safety testing institutions

Testing Category Testing Item
Human safety test Human Skin Patch Test
Safety Evaluation of Using Tests of Cosmetics on Human Body
Tests in vivo of UV Protection Efficacy of Cosmetic Sunscreens SPF test
PFA test
Waterproof performance test

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