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China Makes Significant Amendment to New Cosmetic Ingredients Registration

On 23 Jan 2014, China Food and Drug Administration (CFDA) announced the draft release concerning amendments made to registration of new cosmetic ingredients (NCIs) in China. The new regulation if passed successfully will have significant implications for both domestic and foreign cosmetics enterprises. 

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. 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 4 years, 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).
Post market supervision of newly-approved cosmetic ingredients will be significantly enhanced. Applicants are required to establish a comprehensive traceability system and a safety risk info collecting system for NCIs. Applicants will also be required to regularly report production, circulation and usage information to provincial FDAs.

If approved NCIs present safety problem, CFDA will conduct a re-evaluation which will require applicants to gather supplementary safety data, with the possibility of the registration permit being revoked.
 

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