Overview:
In China toothpaste refers to solid and semi-solid preparations used on the surface of human teeth and surrounding tissues by friction for the purpose of cleaning, beautifying and protecting. Toothpaste is managed according to cosmetics and belongs to non-special purpose cosmetics.
The toothpaste is not defined as cosmetics but managed as general cosmetics in China, which needs to follow notification procedures. The toothpaste can claim anti-caries, inhibiting plaque, anti-dentine hypersensitivity, gum problem alleviation, etc.
Definition of Cosmetic:
Cosmetics refer to daily chemical industrial products that are applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying, and modifying.
Cosmetics are divided into special-purpose cosmetics and non-special-purpose cosmetics. The state implements registration management for special-use cosmetics, and records management for non-special-use cosmetics. Cosmetics used for hair coloring, perming, freckle whitening, sun protection, anti-hair loss, and cosmetics that claim new effects are special-purpose cosmetics. Cosmetics other than special-purpose cosmetics are non-special-purpose cosmetics.
Regulatory overview
The first import of non-special use cosmetics will only need to be filed in China since November 7, 2018 and registration is not required.
Special-purpose cosmetics can be produced and imported only after they have been registered by the drug regulatory department of the State Council.
Imports of non-special use cosmetics shall be filed with the drug regulatory department of the State Council before import.
Timelines for Registration
| Registration Process | Timeline |
|---|---|
| Product Testing | 30 - 60 days (non-special) 1-8 months (special) |
| Acceptance Bureau | 1-3 Days |
| Technical Review | 90 Days |
| Administrative Review | 20 Days |
| Renewal | Every 5 years |
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.