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Pilot New Online Filing System for Non-special Use Cosmetics Produced in China

Regulation of cosmetics in China has exhibited an overriding trend whereby there have been obvious reductions in pre-market regulatory requirements but far stricter post-market management. The trend is particularly obvious for domestically made non-special use cosmetics (Non-SUC). The CFDA has dramatically changed their approval requirements 

Regulation of cosmetics in China has exhibited an overriding trend whereby there have been obvious reductions in pre-market regulatory requirements but far stricter post-market management. The trend is particularly obvious for domestically made non-special use cosmetics (Non-SUC). The CFDA has dramatically changed their approval requirements and registration process as specified in CFDA Circular No.10-2013 released on 16 Dec 2013 (CL Cosmetic News on 23 Dec 2013).

Under the Circular, from 30 June 2014, cosmetic manufacturers in China are required to file their Non-SUC with provincial FDA through the National Online Filing System before placing their products on the market. The online platform requires submission of formulation data and sales packaging (including label and instruction) while the rest of the registration dossiers can be kept by applicants for subsequent examination by officials within 3 months after products are marketed.

Figure 1. Filing Procedure of Domestic Non-special Use Cosmetic Products (new)

Figure 2. Filing Procedure of Domestic Non-special Use Cosmetic Products (previous)

From the end of May onwards, the new system has been in trail use in Jiangsu, Zhejiang and Guangzhou provinces, which are China’s big cosmetic hubs. In these three provinces manufacturers will be only able to submit information using the online platform. After Jun 30th, this system will be implemented nationally.

Another significant change made to the regulation of domestic Non-SUC is the removal of mandatory animal testing. Cosmetic companies now have the choice to opt for animal tests or alternatives to prove the safety of products (provided non-animal tests are robust enough to substantiate safety). In theory, once manufacturers finish on-line filing successfully, products can be put on the market immediately. However, a serious question remains. What kind of non-animal testing safety report will be acceptable by regulators? The CFDA has yet to issue any official guidance on this issue. An CFDA official once indicated that outlining that guidance documents will draw from experience learned in the wake of the pending new online registration system and industry feedback in the coming months.

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