China is the world’s second‑largest consumer market for cosmetics. It presents a huge potential for massive profits for cosmetics brands and manufacturers, however, the requirement for animal testing deters many cosmetics stakeholders.
Previously, China required all cosmetic products to conduct animal testing. However, after the Measures on the Administration of Registration and Notification Dossier of Cosmetics came into force as of May 2021, animal testing can be exempted under certain conditions.
Table 1 Conditions for Animal Exemption in China
Conditions | |
A | It is general cosmetics. |
B | Manufacturers have obtained a certificate issued by the government to prove their qualification to produce qualified products, such as Good Manufacturing Practices. |
C | The safety assessment results can substantiate the safety of products. |
D | It does not involve New Cosmetic Ingredients. |
E | It is not intended for kids or infants. |
F | Domestic responsible persons, notifiers, and manufacturers of products have no bad records in China. |
For a foreign company, it might be somewhat difficult to fully understand the conditions laid out in the regulations. Thus, ZMUni walks you through the possible confusing parts.
The first confusing part for a foreign brand could be the definition of general cosmetics. According to the Regulation on the Supervision and Administration of Cosmetics, Special cosmetics refer to cosmetic products with claims of hair dye, hair perm, anti-hair loss, sunscreen, spot-removing, whitening, and other new efficacy claims. All the other cosmetic products are deemed as general cosmetics.
The second part that might require explanation is the qualification of manufacturers. Under regulations, if one product has been contracted to several manufacturers, all the parties involved shall obtain a certificate issued by the government to prove their qualification to produce qualified products, such as Good Manufacturing Practices.
Another part that might need further clarification is the substantiation of the safety of products. With regard to the Technical Guidance on the Safety Assessment of Cosmetics, a safety assessment report normally covers the abstract, product introduction, formula, formula design principle (only required for kids' cosmetics), the safety assessment of each ingredient, the signature, and resume of safety assessor, references, appendix, etc.
As for cosmetic products that can not be exempted from animal testing, some alternative testing methods can be adopted to substantiate the safety of cosmetics. Table 2 lists officially permitted alternatives to animal testing in China.
Table 2 Alternatives to Animal Testing Permitted in China
Testing | Application Field | Testing Purpose | Does it involve animals? |
In vitro 3T3 NRU phototoxicity test | Cosmetic ingredients | To assess the phototoxicity of cosmetic ingredients | No |
Short Time Exposure In Vitro Test Method (STE) | Cosmetic ingredients | To assess the eye irritation of cosmetic ingredients | No |
In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA) | Cosmetic ingredients | To assess the skin sensitization of cosmetic ingredients | No |
Bacterial Reverse Mutation Assay | Cosmetic ingredients or products | To assess the gene mutation of Cosmetic ingredients or products | No |
In Vitro Mammalian Cells Chromosome Aberration Test | Cosmetic ingredients or products | To assess the mutagenicity o Cosmetic ingredients or products | No |
In Vitro Mammalian Cell Gene Mutation Test | Cosmetic ingredients or products | To assess the mutagenicity o Cosmetic ingredients or products | No |
In Vitro Mammalian Cells Micronucleus Test | Cosmetic ingredients or products | To assess the mutagenicity o Cosmetic ingredients or products | No |
In conclusion, it is not mandatory to have animal testings to import cosmetic products to China under certain conditions and there are officially permitted alternatives to animal testing. This allows many cosmetics brands or manufacturers who adhere to cruelty-free to enter the Chinese market compliantly. As the voice for the phasing out of animal testing gets louder globally, China is also committed to optimizing cosmetics regulations and adopting alternatives to animal testing that ensure the safety and well-being of both humans and animals.
By Yingying
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