CFDA publishes amendment of cosmetic registration

By Michelle Yeomans

- Last updated on GMT

CFDA publishes amendment of cosmetic registration

Related tags Cfda

China’s FDA has welcomed public comments on the amendment of new cosmetic ingredient registration management rules.

The Food & Drug Administration has implemented a protection period of up to four years for new cosmetic registrants, a move that will benefit the industry in its aims to protect the interests of registrants.

In the past, once a new cosmetic ingredient has been approved by CFDA through a public notice, it can be used or sold by every company, which is unfair to the registrant who has made significant efforts to develop a new product and get it approved in China.

However, the notice does not get rid of new cosmetic ingredient registrations or reduce the difficulty of getting a new cosmetic ingredient (NCI) approved in China.

China regulatory affairs specialist April Guo told that guidelines on the registration and evaluation of new cosmetic ingredients will be revised but it is too early tell to whether the registration and evaluation process is going to be simplified.

"The management of new cosmetic ingredient registration is getting closer to new substance notifications in China now​," she says.

Details of the notice

Under proposed rules, CFDA will not publish any notices on new cosmetic ingredient approvals from 1st April 2014.

Only companies that have registered a new cosmetic ingredient and have obtained a “new cosmetic ingredient trial use certificate​” (valid for 4 years) are allowed to produce, sell or use it. During the 4 years, other companies who intend to sell or use the same cosmetic ingredient need to do their own registrations.

After that period, the CFDA will re-evaluate the safety of the ingredient based on its use. If the result of the evaluation is that the ingredient is safe under its conditions of use, it will be added to the Inventory of Existing Cosmetic Ingredients in China (IECIC).

The notice also requires registrants to fulfill more post-registration obligations such as establishing a traceability system, monitoring risk info on new cosmetic ingredient and reporting the information on production, circulation, use and safety-related info to food and drug authorities.

CFDA may revoke registrant’s certificates if registrants fail to meet their post-registration obligations.

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