Changes Regarding the Approval of “Non-Special” Cosmetics

On 07.11.2018, the NMPA (former NMPA) released a notice regarding the new approval process of “non-special” cosmetics in China (NMPA No.88-2018). In the past, foreign manufactured “non-special” cosmetics had to the choice between two approval processes:
– NMPA Registration in Beijing
– Filing in one of 11 Pilot New Trade Zones1

As of 10 November 2018, foreign manufacturers have no choice anymore:
“Non-special” cosmetics have to undergo filing.
“Special” cosmetics have to undergo registration.

What has changed for applicants of “non-special” cosmetics?
– With 3 to 4 months, the filing procedure is much faster2.
– The validity of the filing is unlimited.
– The responsibilities of the NMPA Responsible Person (former NMPA Legal Agent) are more extensive and includes not only the filing, but also import, distribution and responsibility for product safety. The choice of a suitable person is therefore even more important.
– The manufacturer can appoint multiple NMPA Responsible Persons now. Each product can be handled by one NMPA Responsible Person.
– When an old NMPA certificate runs out after 4 years, no renewal application is possible anymore; instead the product has to be filed in order to continue to be sold.
– If you the applicant wishes to carry out the notification in one of the 11 New Trade Zones, the NMPA Responsible Person must be located in the respective zone. The import is then limited to the port of this zone; except an application for additional ports is submitted.
– When the notification is done in Beijing, the residence of the NMPA Responsible Person is not limited to Beijing and the free selection of import ports within China is possible.

What remains the same for applicants of “non-special” cosmetics?
– The required application documents, sample tests and associated costs remain mostly the same.
– Animal tests are still compulsory for foreign cosmetics.