Regulations for Cosmetic Registration and Notification Testing

A scientist using pipette for chemical analysis in a laboratory with test tubes and protective gloves.

The Work Specifications for Cosmetic Registration and Notification Testing apply to all testing activities related to the registration and notification of cosmetics within the People’s Republic of China. This includes microbiological testing, physical and chemical (physicochemical) testing, toxicological testing, and human safety and efficacy evaluations.


Table 1: Microbiological Testing Items

Testing ItemGeneral Cosmetics ①②Special Cosmetics: Anti-hair loss ②Special Cosmetics: Hair Dyeing ③Special Cosmetics: Hair PermingSpecial Cosmetics: Spot-clearing / WhiteningSpecial Cosmetics: Sunscreen
Total Plate Count
Total Mold & Yeast Count
Thermotolerant Coliform Bacteria
Staphylococcus aureus
Pseudomonas aeruginosa

Notes:

  1. Nail polish removers do not require microbiological testing.
  2. Products with ethanol content $\ge$ 75% (w/w) do not require microbiological testing.
  3. Physical hair removal products and non-oxidative hair dyes require microbiological testing.
  4. indicates a mandatory testing item.

Table 2: Physicochemical Testing Items

Testing ItemGeneral CosmeticsAnti-hair lossHair DyeingHair PermingSpot-clearing / WhiteningSunscreen
Mercury
Lead
Arsenic
Cadmium
Thioglycolic Acid
UV Filters ⑤
Hair Dyes
pH Value ⑥

Notes on Physicochemical Testing Requirements:

  1. Methanol: Testing is required for products where the combined content of Ethanol and Isopropanol is $\ge$ 10% (w/w).
  2. Dioxane: Testing is required for products containing raw materials with an ethoxy structure in the formulation.
  3. Asbestos: Testing is required for products containing Talcum powder as a raw material.
  4. Free Formaldehyde: Testing is required for products containing Formaldehyde or Formaldehyde-releasing agents.
  5. Chemical UV Filters: For non-sunscreen products that contain chemical UV filters in the formula, testing must be conducted to verify the specific UV filters present.
  6. $\alpha$-Hydroxy Acids (AHAs) and pH Value: * Testing for $\alpha$-Hydroxy Acids and pH value is mandatory for products that either claim to contain AHAs or contain a total AHA concentration of $\ge$ 3% (w/w) (even if not claimed).
    • Pure oil-based products (including wax-based) are exempt from pH value testing.
    • For products consisting of multiple components used together, the pH value must be tested for each individual component as well as for the final mixture as prepared according to the instruction manual.
  7. Anti-dandruff Agents: Testing for the specific anti-dandruff agents is required for products where the declared purpose of any raw material in the formulation is as an anti-dandruff agent.
  8. UVA Protection: Products claiming UVA protection or broad-spectrum sun protection must be tested for UVA protection parameters, specifically the Critical Wavelength or the PFA value.
  9. Special Packaging Sampling: For finished products where sampling is impossible or testing results may be affected due to packaging (such as aerosols/sprays or cushion products), the company may provide the semi-finished product from the final stage of the manufacturing process alongside the complete finished samples. The testing institution must specify this in the final inspection report.

Table 3: Toxicological Testing for General Cosmetics

Testing ItemHair Care (Eye contact)Skin Care (General)Skin Care (Eye contact)Makeup (General)Makeup (Eyes)Lips
Acute Skin Irritation
Acute Eye Irritation
Multiple Skin Irritation

Notes on Toxicological Testing Requirements:

Bath Products: Bath/Shower products must undergo an acute eye irritation test.

Product Scope: For products not specifically mentioned in the tables, testing items should be determined based on actual conditions. Items may be increased or decreased according to the specific use and category of the product.

Nail Products: Repair and color-coating nail (toe-nail) products do not require toxicological testing.

Chemical UV Filters: For products containing $\ge$ 0.5% (w/w) chemical UV filters (excluding rinse-off products, perfumes, and nail polishes), skin phototoxicity and skin sensitization tests must be conducted in addition to the standard items listed in the table.

Rinse-off Skin Care: Rinse-off skin care products only require an acute skin irritation test; multiple skin irritation tests are not necessary.

Exemptions from Eye Irritation: Leave-on hair care products and eyebrow makeup (such as eyebrow pencils/powders) do not require an acute eye irritation test.


Table 4: Toxicological Testing for Special Cosmetics

Testing ItemAnti-hair lossHair DyeingHair PermingSpot-clearing / WhiteningSunscreen
Acute Eye Irritation
Acute Skin Irritation
Multiple Skin Irritation
Skin Sensitization
Skin Phototoxicity
Ames Test / Chromosome Aberration○ ⑥
  • Notes on Toxicological Testing for Special Cosmetics:
  • General Rule: For products not specifically covered in the table, testing items should be determined based on the actual situation. Testing items may be increased or decreased according to the specific intended use and product category.
  • Eye Irritation: Spot-clearing/Whitening and Sunscreen products that are likely to come into contact with the eyes must undergo an acute eye irritation test.
  • Rinse-off Products: Rinse-off products only require an acute skin irritation test; a multiple skin irritation test is not required.
  • Phototoxicity: In addition to anti-hair loss, sunscreen, and spot-clearing products, any product with a chemical UV filter content $\ge$ 0.5% (w/w) (excluding perfumes and nail polishes) must also undergo a skin phototoxicity test.
  • Genetic Toxicity Options: Either the Bacterial Reverse Mutation Test (Ames test) or the In Vitro Mammalian Cell Gene Mutation Test may be selected.
  • Non-oxidative Hair Dyes: Non-oxidative hair dye products are exempt from the Bacterial Reverse Mutation Test and the In Vitro Mammalian Cell Chromosome Aberration Test.
  • Multi-component Products: Products consisting of two or more parts to be mixed must be tested according to the usage methods in the instructions. If there are multiple usage methods involving different concentrations or ratios that affect safety, each scenario must undergo relevant toxicological testing.

Table 5: Human Safety Evaluation Items

Testing ItemGeneral CosmeticsAnti-hair lossHair DyeingHair PermingSpot-clearing / WhiteningSunscreen
Human Skin Patch Test
Human Use Safety Evaluation

Notes on Human Safety Evaluation:

Multi-component Products: For products consisting of two or more parts to be mixed, testing must follow the usage instructions. If there are multiple usage methods involving different concentrations or mixing ratios that impact safety, a relevant human safety evaluation must be performed for each specific scenario.

Skin Patch Testing: For Spot-clearing and Sunscreen cosmetics, if the human skin patch test results show irritation or are difficult to interpret, an additional Repeated Open Application Test (ROAT) must be conducted.

Low pH Products: Leave-on products with a physicochemical test result of pH $\le$ 3.5, or products where the corporate standard sets the pH at $\le$ 3.5, must undergo a human use safety evaluation.

Specific Rinse-off Claims: All rinse-off products claiming efficacies such as anti-acne, anti-wrinkle, or spot-clearing must undergo a human use safety evaluation.


Table 6: Efficacy Evaluation Testing Items

Product CategoryTesting Item
SunscreenSPF Determination; PFA/PA Determination; Water Resistance (if claimed).
OthersItems required by the Technical Guidelines for Cosmetic Efficacy Claim Evaluation.

Notes on Efficacy Evaluation Testing:

Other Special Claims: Products claiming spot-clearing/whitening, anti-hair loss, or new efficacies must undergo corresponding efficacy testing and have an official test report issued in accordance with the requirements set by the Technical Guidelines for Cosmetic Efficacy Claim Evaluation.

SPF Testing: Products claiming sun protection (sunscreen) must be tested for their Sun Protection Factor (SPF) value.

UVA Protection: * Products labeled with a PFA value or PA+ to PA++++ must be tested for the Protection Factor of UVA (PFA).

Products claiming UVA protection or broad-spectrum sun protection must be tested for either the critical wavelength or the PFA value.

Water Resistance: If a sunscreen product claims to be “water-resistant,” “sweat-resistant,” or “suitable for swimming and other outdoor activities,” its water resistance must be tested according to the prescribed methods based on the claimed level of resistance or duration.

Non-Sunscreen Products: For non-sunscreen cosmetics where the total content of chemical UV filters is $\ge$ 0.5% (w/w) (excluding rinse-off products, perfumes, and nail polishes), testing for the SPF value is required.

Multi-component Products: Products consisting of two or more parts to be mixed must be tested according to the usage methods in the instructions. If there are multiple usage methods involving different concentrations or ratios that affect safety, each scenario must undergo relevant human efficacy evaluation testing.

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