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Latest NewsNewsRegulationsZMUni25/11/2022Cosmetics Testing Required for Registration and Notification in China

In China, cosmetics are defined as chemical products intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body like skin, hair, nail, mouth, etc. for cleansing, beautifying, promoting attractiveness, or altering the appearance. Cosmetics that claim to have the efficacy of sun protection, anti-hair loss, whitening and freckle-removing, hair dyes, and germ are considered special cosmetics, while all the other products are considered general cosmetics. They are subject to different supervision measures and require different cosmetics testing for registration and notification in China. This article presents the requirements of physicochemical testing, microbiological testing, toxicity testing, safety testing on humans, and efficacy testing for different products.

 

1. Physicochemical Testing

○ is the symbol for the required test

Notes:

① Test for methanol is required when the concentration of ethanol and isopropanol is equal to or greater than 10% (w/w) in products.

② Test for dioxane is required when products contain ethoxylated compounds.

③ Test for asbestos is required when products contain talcum powder.

④ Test for free formaldehyde is required when products contain formaldehyde or ingredients releasing formaldehyde.

⑤ Test for chemical sunscreen agents is required for non-sunscreen products containing chemical sunscreen agents.

⑥ Test for alpha-hydroxy acid and pH is required for products claiming to contain alpha-hydroxy or products containing ≥3% alpha-hydroxy even without claiming to contain this substance. Pure oil (wax-based) products do not need pH testing. As to products intended to be applied in a combined manner, a test for pH is required for both individual product and their combined products.

⑦ Test for the anti-dandruff agent is required for products containing ingredients with the function of anti-dandruff.

⑧ Test for UVA resistance parameters – critical wavelength is required for products claiming to have the function of sun protection.

If the final products can not be sampled due to packaging or the sampling may affect the test results, e.g. self-pressurized container, cushion compacts, enterprises can provide semi-products in the last process before packaging while submitting the whole products, which shall be stated in the testing report.

 

2.Microbiological Testing

Notes:

① Nail polish remover does not require microbiological testing.

② Products with ethanol ≥75% (w/w)do not require microbiological testing.

③ Microbiological testing is required for physical depilation products and non-oxidative hair dye products.

 

3.Toxicity Testing

Notes:

① Products not listed in the table can add or skip some tests in light of their functions and categories.

② Toxicity test is not required for repairing and painting nail products.

③ Skin phototoxicity test and skin sensitization test are required for products with ≥0.5% chemical sunscreen agents other than rinse-off products, perfumes, and nail polishers.

④ Rinse-off skincare only needs to carry out acute skin irritation tests and does not need to carry out multiple skin irritation tests.

⑤ Leave-on hair care products or eyebrow make-up do not need to carry out acute eye irritation tests.

⑥ Acute eye irritation test is required for bath products.

 

Notes:

① Products not listed in the table can add or skip some tests in light of the functions and categories of products.

② Acute eye irritation is required for freckle-removing products and sunscreen that may contact eyes.

③ Rinse-off products only need to carry out acute skin irritation test and do not need to carry out multiple skin irritation test.

④ Other than products for hair growth, sunscreen, and freckle-removing, a skin phototoxicity test is required for products containing ≥0.5%(w/w) chemical sunscreen agents except for perfume and nail polishers.

⑤ As to bacterial reverse mutation assay, bacterial reverse mutation assay and in vitro mammalian cell chromosomal aberration assay can be used.

⑥ Non-oxidative hair dyes do not need to carry out bacterial mutation test and in vitro mammalian cell chromosomal aberration assay.

⑦ For two or more products used in combination, tests shall be carried out according to the usage methods laid down in the instructions. When there are different usage methods related to safety, such as different concentrations and different ratios, toxicity tests shall be carried out for each situation.

 

4.Safety Testing on Humans

Notes:

① Human skin patch test is required for freckle-removing products and sunscreen. When irritation occurs or the result is unclear, the test of applying products repeatedly on the skin should be added.

② Safety evaluation of using cosmetics on humans is required for leave-on products whose pH is ≤3.5 in physicochemical testing or the pH of products is set ≤3.5 according to their production standards.

③ Safety evaluation of using cosmetics on humans is required for rinse-off products that claim to have the efficacy of anti-acne, anti-wrinkle, freckle-removing products, etc.

④ For two or more products used in combination, tests shall be carried out according to the usage methods laid down in the instructions. When there are different usage methods related to safety, such as different concentrations and different ratios, toxicity tests shall be carried out for each situation.

 

5.Efficacy Testing

Notes:

① Test for SPF is required for products that claim to have the efficacy of sun protection.

② Test for PFA value is required for products labeled PFA or PA+~PA++++; Test for UVA resistance parameters – critical wavelength is required for products that claim to have the efficacy of UVA protection or broad-spectrum sunscreen.

③ Products that claim to have the efficacy of waterproof, sweat proof, suitable for outdoor activities like swimming, etc. shall carry out the waterproof test according to their claims on waterproof duration and degree.

④  Test of SPF is required for non-sunscreen products with ≥0.5%(w/w)chemical sunscreen agents, other than rinse-off products, perfumes, and nail polishers.

⑤ For two or more products used in combination, tests shall be carried out according to the usage methods laid down in the instructions. When there are different usage methods related to safety, such as different concentrations and different ratios, toxicity tests shall be carried out for each situation.

 

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