NMPA issued the announcement on new specifications for the implementation of cosmetics registration and filing inspection (No. 72, 2019) in order to ensure the process is “open, fair, just and scientific.”
The new rules require non-sunscreen products containing chemical sunscreen agents to be tested for the compounds.
April Guo, general manager, personal care division at Hangzhou-based consulting firm Chemical Inspection and Regulation Service (CIRS), said these products include normal skin care cream, make-up products, and perfume.
For non-special cosmetics with the content of chemical sunscreen agent ≥0.5% (w/w) (except rinse-off, perfume and nail polish products), in addition to the mandatory test above, skin phototoxicity test and skin sensitisation test should be conducted.
Guo said non-special use cosmetics in China include skin care, make-up, perfume, nail care and hair care.
For special use cosmetics, skin phototoxicity test is required for products with the content of chemical sunscreen agent ≥0.5% (w/w) (except perfume and nail polish products).
Special use cosmetics in China are products for hair growth, hair dye, hair perm, depilation, deodorization, breast shaping, fitness, sunscreen, anti-freckle, said Guo.
An SPF test is also required for non-sunscreen products with total amount of chemical sunscreen agents ≥0.5% (w/w).
Rinse-off, perfume and nail polish products were exempted from the tests.
Instead, rinse-off products for anti-acne treatment, anti-wrinkle and anti-freckle should be evaluated through human trial safety test.
Anti-acne and anti-mite products also no longer require antibiotics and metronidazole tests.
NMPA said all newly registered or filed cosmetics products must be tested in accordance with the new regulations before they can be placed on the market.
Cosmetics that have already been tested will need to submit a supplementary testing report when they renew their licence every four years.
The new specifications also allow third-party testing institutions to conduct these tests in China, however they must first register with the NMPA, and receive the China Metrology Accreditation (CMA) certification in the field of cosmetics.
The CMA is the most basic inspection and testing market access requirement in China..
Dr Alain Khaiat, president of Seers Consulting told CosmeticsDesign-Asia that previously, product testing were done in-house or at third parties depending on the tests and the companies, however, “The new requirement mandates that SPF be done in institutions that have been accredited by the Chinese national metrology and accreditation agency. The concern the industry has is that there are only very few institutions that have been accredited and they are all in China.”
According to CIRS, “The release and implementation of the specifications allows more third-party inspection institutions to participate in the inspection work of cosmetics registration and filing, which greatly avoids the phenomenon of queuing and helps enterprises to speed up the progress of product launching.”’
The specifications also outlined that all companies are required to use an online system to apply for these services from November 1.
CIRS said this meant that cosmetic enterprises were to register and file for inspection, inspection institutions were to accept inspection applications, and government to carry out supervision work on product safety and efficiency and inspection institutions, all conducted online.
With the new rules, the qualification of previously designated cosmetics administrative licensing or filing inspection institution would be terminated from November 1.