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CFDA Approves Test Methods for Prohibited and Restricted Substances in Cosmetics

On 25 May, China Food and Drug Administration released test methods for a batch of substances prohibited and restricted in cosmetic products, aiming to further standardize requirements for cosmetics testing and enhance the safety and quality of cosmetics. 

On 25 May, China Food and Drug Administration released test methods for a batch of substances prohibited and restricted in cosmetic products, aiming to further standardize requirements for cosmetics testing and enhance the safety and quality of cosmetics.

To be specific, test methods are available for the following substances:

Test Method 1. High Performance Liquid Chromatography (HPLC)

EN Name CN Name CAS Property
Diethyl maleate 马来酸二乙酯 141-05-9 Prohibited
ACID VIOLET 43 酸性紫43 (CI 60730) 4430-18-6 Colorant
Basic Violet 14 碱性紫14 (CI 42510) 632-99-5 Colorant
Acid Orange 3 酸性橙3 (CI 10385) 6373-74-6 Colorant
Basic yellow 87 碱性黄87 116844-55-4 Colorant
Basic Blue 26 碱性蓝26 (CI 44045) 2580-56-5 Colorant
Basic red 51 碱性红51 12270-25-6 Colorant
Basic orange 31 碱性橙31 97404-02-9 Colorant
FOOD RED 9 食品红9 (CI 16185) 915-67-3 Colorant
FOOD RED 7 食品红7 (CI 16255) 1390-65-4 Colorant
FOOD RED 17 食品红17 (CI 16035) 25956-17-6 Colorant
FOOD RED 1 食品红1 (CI 14700) 4548-53-2 Colorant
ACID RED 87 酸性红87 (CI 45380) 548-26-5 Colorant
ACID ORANGE 7 酸性橙7 (CI 15510) 633-96-5 Colorant
SOLVENT GREEN 7 溶剂绿7 (CI 59040) 6358-69-6 Colorant
ORANGE I 橙黄 I 523-44-4 Colorant
FOOD YELLOW 3 食品黄3 (CI 15985) 2783-94-0 Colorant
ACID YELLOW 121 酸性黄1 (CI 10316) 846-70-8 Colorant
Aminocaproic Acid 氨基己酸 60-32-2  
Chlorphenesin 氯苯甘醚 104-29-0 Preservative
Tretinoin 维甲酸 302-79-4 Prohibited
Isotretinoin 异维甲酸 4759-48-2  
Sorbicacid 山梨酸 110-44-1  
Dehydroacetic Acid 脱氢乙酸 520-45-6  
Salicylic acid 水杨酸 69-72-7 Restricted
Zinc pyrithione 吡硫翁锌   Restricted/Preservative
Ketoconazole 酮康唑   Prohibited
Climbazole 氯咪巴唑 38083-17-9 Preservative
Piroctone olamine 吡罗克酮乙醇胺盐 68890-66-4 Preservative

Test Method 2. Using Headspace Gas Chromatography Flame Ionization Detector (HS-GC-FID)

EN Name CN Name CAS Property
Ethylene oxide 环氧乙烷 75-21-8 Prohibited
Methyloxirane 甲基环氧乙烷 75-56-9 Prohibited

Test Method 3. Liquid Chromatographic Tandem Mass Spectrometry (LC/MS/MS)

EN Name CN Name CAS Property
Enoxacin 依诺沙星 74011-58-8 Prohibited
Fleroxacin 氟罗沙星 79660-72-3 Prohibited
Ofloxacin 氧氟沙星 82419-36-1 Prohibited
norfloxacin 诺氟沙星 70458-96-7 Prohibited
Pefloxacin 培氟沙星 70458-92-3 Prohibited
Ciprofloxacin 环丙沙星 85721-33-1 Prohibited
Enrofloxacin 恩诺沙星 93106-60-6 Prohibited
Sarafloxacin 沙拉沙星 98105-99-8 Prohibited
Difloxacin 双氟沙星 98106-17-3 Prohibited
Moxifloxacin 莫西沙星 151096-09-2 Prohibited
Griseofulvin 灰黄霉素 126-07-8 Prohibited
ketoconazole 酮康唑 65277-42-1 Prohibited
clotrimazole crystalline 克霉唑 23593-75-1 Prohibited
Econazole 益康唑 27220-47-9 Prohibited
Miconazole 咪康唑 22916-47-8 Prohibited
Fluconazole 氟康唑 86386-73-4 Prohibited
Bifonazole 联苯苄唑 60628-96-8 Prohibited
Ciclopirox olamine 环吡酮胺 41621-49-2 Prohibited
Naftifine 萘替芬 65472-88-0 Prohibited

Test Method 4. Gas Chromatography

EN Name CN Name CAS Property
α-Chlorotoluene α-氯甲苯 100-44-7 Prohibited
Di-ethylene glycol 二甘醇 111-46-6

In the Cosmetic Ingredient:

1,2-Propanediol

Test Method 5. Iron Chromatography 

EN Name CN Name CAS Property
Ethanolamine 乙醇胺 141-43-5 Prohibited
Diethanolamine 二乙醇胺 111-42-2  
Triethanolamine 三乙醇胺 102-71-6  
Dimethylamine 二甲胺 124-40-3  
Diethylamine 二乙胺 109-89-7  

Prohibited and restricted substances are included in the Hygienic Standards for Cosmetics 2007, which is being revised by CFDA and renamed as “Technical Safety Standard for Cosmetics”. Though the body text has been released for public comments last Dec (see Chemlinked news on 7 Dec 2012), its three annexes shown as follows are pending:

  • Annex I: Technical requirements for cosmetic ingredients
  • Annex II: Requirements for prohibited and restricted substances in cosmetics, including prohibited and restricted substances in cosmetics
  • Annex III: Test methods (physic-chemical/ microbiological/toxicological/human safety/efficacy)

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