On 27 May 2019, China’s National Medical Products Association (NMPA) announced the draft regulation for non-special use cosmetics filing. The draft aims at leveling the playing field for the domestic and imported cosmetics sold in China. Most importantly, the draft proposes that animal test should no longer be mandatory for imported non-special use cosmetics; a requirement that has proven a very effective trade barrier for foreign cosmetics brands with ambitions to sell in China. The draft may however also introduce new administrative obstacles for imported cosmetics and includes much stricter requirements to the responsible agent.
During the last couple of years, various initiatives have been introduced to speed up the process to remove mandatory animal test for imported cosmetics. IIVS have been working closely with the NMPA authorized laboratories by providing training in in-vitro test (also called alternative test to animal test). In addition, the Leaping Bunny China Pilot project, launched in 2018, provided an alternative route to the Chinese market for imported cosmetics through local manufacturing. Both initiatives have aided the dialogue in China on the need to remove mandatory animal test for imported cosmetics. With the new draft regulation, mandatory animal test is removed for non-special use cosmetics when adhering to a number of additional requirements.
Overall, the new draft regulation for non-special use cosmetics is good news for imported cosmetics brands. For the first time imported cosmetics may be exempted from the use of animal test as part of toxicology test. In 2015, the Chinese government exempted the domestic industry from mandatory use of animal test, but now the playing field is being leveled; the new regulations applies equally for local and imported cosmetics. While the domestic cosmetic industry will have to adhere to a number of additional requirements that has previously only applied to imported cosmetics, mandatory animal test has been removed.
One element in the draft regulation (article 11) that has caused some concerns is the requirement that cosmetics manufacturers are required to have “a government approved quality management system” – if they wish to waive toxicology test. Whether the Chinese government, or the local government should authorize this system is not clear from the draft – nor is it described what a “quality management system” implies. This element caused much discussion in the global cosmetics industry, as there is no global certification that covers “quality management system”. Some alternatives could be ISO certificates, GMP certificates (presently no global GMP certificates exist), or a so-called “manufacturing licenses” as used in China. It is expected that the authorities will provide more details on this article soon.
Other elements in the new draft regulations worth noting are the stringent requirements to the responsible agent. In essence; an imported cosmetics brand must appoint a responsible agent in China, who is liable for product safety and quality including product recall, product safety monitoring, as well as reporting of product sales/distribution. As the punishment for non-compliance has become much severer, it is expected to be more difficult for foreign brands to find local responsible agents. One alternative is to establish a legal entity (WFOE) in China who can act as responsible agent for the imported cosmetics – another solution can be provided by Knudsen&CRC (email; info@knudsencrc.com for more information).
The government have stressed that the reason for the new stricter supervision and regulations for domestics cosmetics products is due to their efforts on boosting the international branding of “Made in China” cosmetics. The Chinese cosmetics industry along with Chinese cosmetics brands are getting ready for international expansion – and an important part is the branding of an innovative, high quality Chinese cosmetics industry.
An unofficial translation of the new draft regulation can be downloaded below.
For more information about the Leaping Bunny China Pilot Project, please visit our website or contact us directly; info@knudsencrc.com