The NMPA drafted the acceptance of nine test methods including two animal-free tests: Direct Peptide Reaction Assay (DPRA) for Skin Sensitization and Short Time Exposure Assay (STE) for eye irritation.
From January 1, 2020, these tests will be the preferred toxicological tests for the registration and pre-market approval of cosmetic ingredients, but not final formulations.
Total ban on animal testing still unlikely
While this is a significant step towards phasing out animal testing for the country, Erin Hill, president of the Institute for In Vitro Sciences (IIVS), does not think it will move to ban animal testing in the near future.
“I feel that a ban on animal testing for cosmetics in China is unlikely in the near future for several reasons. Although the country is making great strides in building its infrastructure, it is going to take some time until there are enough proficient laboratories and approved alternative methods,” said Hill.
She added that a ban in the short-term would have negative impacts on the local cosmetic companies.
“Some domestic cosmetic companies do not have internal experience with alternative methods or risk assessment,” she explained.
Additionally, Hill noted that alternative test methods in the OECD Test Guideline program were not validated for final formulations.
This means China still requires foreign companies to subject their products to toxicology testing before they can be sold on the shelves in China.
“Either the regulations would need to change to a risk-assessment process, or methods would need to be validated for formulations – either scenario could be a lengthy process,” said Hill.
Hill concluded: “I think it is more likely that China will continue to accept internationally accepted alternative methods and slowly shift its infrastructure and regulations without implementing a ban in the short-term.”
China on the right path
According to the IIVS, the NMPA is working to modernise its regulatory oversight for cosmetics.
“The NMPA and its scientific subordinate body, the National Institutes for Food and Drug Control (NIFDC), have been working to gain experience and build confidence in non-animal testing approaches.”
NIFDC and IIVS are currently working under a Memorandum of Understanding (MOU) by collaborating to bring more alternative test methods to China.
IIVS also provides training for Chinese scientists on animal-free testing methods.
According to IIVS, the program has trained more than a hundred scientists in numerous test methods, including the first officially approved non-animal test method, the NRU 3T3 Phototoxicity assay, and the recently approved test methods, DPRA and STE.
“We have seen first-hand how the partnership with NIFDC and our training program have built capacity and proficiency in alternatives,” said Hill.
“The opening of the alternatives laboratory at the Zhejiang Institute for Food and Drug Control (ZJIFDC) is a wonderful example of how laboratories can expand to offer training and testing services in alternative test methods.”
Additionally, IIVS collaborates with other influential groups in China, such as the Expert Committee of Cosmetics Standards and Cosmetic Review Committees, to advocate for the use and acceptance of alternative testing methods.
