Testing Fees of Imported Cosmetics CFDA Registration in China including non-special use cosmetics and special use cosmetics

Below is the updated estimated testing fees of imported cosmetics CFDA registration for reference. Please note that the testing fees will be charged differently based on actual situation.

Table 1. Inspection Items, Time, Sample Quantity and Cost on imported non-special use cosmetics1

                    Category

Item

Hair Care Skincare Makeup Nail care11 Aromatic
General Eye Contact General Eye Contact General Eye makeup
Microbiology test2 Ο Ο Ο Ο Ο Ο Ο Ο
Lead, mercury, arsenic Ο Ο Ο Ο Ο Ο Ο Ο
Methanol3 Ο
Alpha hydroxy acid, pH4
Antibiotic,metronidazole5
Anti dandruff agent6
Asbestos7
Acute skin irritation test8 Ο Ο Ο Ο
Acute eye irritation test9 Ο Ο Ο
Multiple skin irritation test Ο Ο Ο Ο
Test time (Day) 35 35 60 60 60 60 25 25
Sample quantity

(Serving)10

12 12 12 13 12 13 11 11
Cost (RMB) 4600 6600 5600 7600 5600 7600 4600 5100

Notes:

  1. If a sample package contains more than two separate small packages or boxes (such as powder, eye shadow, blush etc.), and has the same product name, are subject to relevant test respectively; whether a sample package which does not contain separate packages or boxes with the same raw material formulation excluding colorants should be tested respectively or not is determined by the direction of use according to the package insert. All the sun block agents (excl: Zinc oxide and titanium dioxide) content ≥0.5%(w/w) need to do sunscreen test, skin allergy test and skin photo toxicity test, need additional 4 sample servings at least and added amount is no less than 50g
  1. Nail Lacquer/Remover do not need to do microbiology test. Ethanol content ≥75%(w/w) do not need to do microbiology test.
  2. Total Ethanol and isopropanol content ≥10%(w/w) need to do Methanol test
  3. Alpha hydroxyl acid content ≥3%(w/w) need to do Alpha hydroxyl acid test as well as PH test
  4. Products with function claim of anti-acne, anti-mites, etc. need to do Antibiotic and Metronidazole test
  5. Function claim of Anti dandruff need to do Anti dandruff agent test
  6. Product containing talcum powder needs to do Asbestos test
  7. Shower products, face masks (except long-lasting face masks) and skin care product only need to do acute skin irritation test, no need to do multiple skin irritation test.
  8. Leave-on conditioners and eyebrow makeup products do not need to do acute eye irritation test. Body shower product need to do acute eye irritation test.
  9. If product per serving content < 20g, then more servings need to be provided. Include sealed samples, inspection report provided by CFDA.
  10. Nail (toes) repair products and nail (toes) polish products do not need toxicology test.

Inspection Items, Time, Sample Quantity and Cost on imported special-use cosmetics1

                             Category

Item

Hair Growth2 Body building

/Beauty breast

Hair Dye31015 Perm3 Sunscreen Deodorant3 Freckle removal Hair removal3
Microbiology test O O O O
Lead, mercury, arsenic O O O O O O O O
Methanol4          
Formaldehyde O
Thiol acetic acid O O
Phenol, hydroquinone O
Sex hormone O O
Sunscreen agent5 O
Oxidative Hair Dyes O
Nitrogen mustard, cantharidal O
pH6 O O O
Alpha hydroxy acid6
Antibiotic, metronidazole7
Anti-dandruff agent8
Asbestos 9
Acute eye irritation test O O O
Acute skin irritation test O
Multiple skin irritation test 11 O O O O O
Skin allergic test O O O O O O O O
Skin photo toxicity test12 O O O
Salmonella typhimurium reverse

mutation assay 13

O O O14
In Vitro Mammalian Cells

Chromosome Aberration Test

O O O14
Test time (Day) 80 80 80 60 80 80 80 80
Sample quantity (Serving)16 21 17 14 14 24 15 19 16
Cost (RMB) 21400 16400 14400 9400 11400 8400 11400 7900

Notes:

  1. If a sample package contains more than two separate small packages or boxes (such as powder, eye shadow, blush etc.), and has the same product name, are subject to relevant test respectively; whether a sample package which does not contain separate packages or boxes with the same raw material formulation excluding colorants should be tested respectively or not is determined by the direction of use according to the package insert.
  2. Ethanol content ≥75%(w/w) do not need to do microbiology test.
  3. Product without microbial inhibition ingredient (ex. hair removal, pure plant extract hair dye products, etc.) need to do microbiology test
  4. Total Ethanol and isopropanol content ≥10%(w/w) need to do Methanol test
  5. In addition to sunscreen products, other products with sun block agent (excl: Zinc oxide and titanium dioxide) content ≥5%(w/w) need to do sunscreen test.
  6. Products with alpha hydroxyl acid content ≥3%(w/w) need to do Alpha hydroxyl acid test as well as PH test
  7. Products with function claim of anti-acne, anti-mites, etc. need to do Antibiotic and Metronidazole test
  8. Products with function claim of Anti dandruff need to do Anti dandruff agent test
  9. Product containing talcum powder needs to do Asbestos test
  10. If hair dye product contain ≥2 agents, dosage form shall be detected according to the health chemical item.
  11. Skin wash products only need to do acute skin irritation test.
  12. In addition to hair growth, sunscreen and freckle removal products, other products with sun block agent (excl: Zinc oxide and titanium dioxide) content ≥5%(w/w) need to do skin photo toxicity test.
  13. For Hair Growth, Body building/ Beauty Breast, Hair dye products, Salmonella typhimurium reverse mutation assay or In Vitro Mammalian Cells Chromosome Aberration Test shall be provided.
  14. Temporary hair dye product does not need to do Salmonella typhimurium reverse mutation assay and In Vitro Mammalian Cells Chromosome Aberration Test
  15. If hair dye product contain ≥2 agents, need to do toxicology test according to the instructions. For domestic special-use cosmetics do not need to provide.
  16. If product per serving content < 25g, then more servings need to be provided. Include sealed samples of imported cosmetics, inspection report provided by CFDA.

Source of from SIFDC, one of the CFDA-appointed lab