The new regulation was introduced to replace the outdated Cosmetics Hygiene Supervision Regulations (CHSR), which was implemented in 1990 and has been a major hurdle to progress and innovation in the rapidly developing local cosmetic industry.
China’s National Medical Products Administration (NMPA) published the final version of CSAR on June 29, after a delay caused by the novel coronavirus (COVID-19) health crisis.
However, the document did not provide any explanation regarding mandatory animal testing in China, which has been a hot button topic in the last few years.
The story so far
According to the current regulations, all cosmetics imported into China by way of general trade are required to conduct animal testing.
Companies can circumvent the mandatory animal testing laws by selling products to customers directly via cross-border e-commerce.
In May 2019, the NMPA released Administration Measures for Filing of Non-Special Use Cosmetics.
According to the final CSAR regulations, non-special use cosmetics are now known as general cosmetics include products such as sun care, brightening skin care, hair dyes or hair perms.
According to the document, general cosmetics would no longer be subjected to mandatory animal testing, regardless whether they are produced domestically or imported into China and safety assessments will be accepted in place of animal testing.
Instead, safety assessments will be accepted in place of animal testing, but here are a few exceptions to this rule.
For instance, animal testing would still apply for products meant for children and infants and products that contain materials not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC).
According to Joanna Ru, a cosmetic regulatory consultant at REACH24H, the industry can expect further clarification on this issue to be announced in the next few months.
“CSAR does not mention any content about animal testing, but the relevant testing requirements for general cosmetics will be released within the following six months," Ru said in a recent webinar hosted on Chemlinked.
The final version also did not mention animal testing in regard to cosmetic ingredient registration.
Ru said: “Animal testing will be still needed for most of the testing. There are more than six types of animal testing for the application of new cosmetic ingredients, like acute oral and dermal toxicity test, skin irritation.”
She added that China currently has an alternative method for skin sensitisation and was working with the scientific community to find more alternative tests.
Based on regulatory trends, Ru said there is a possibility that China would relax the animal testing rules.
“It’s possible that safety risk assessment documents will replace animal testing during the filing process of general cosmetics. The new draft of Administrative Measures for Filing of Non-special Use Cosmetics also indicates this trend.”