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On 23 Jan 2014, 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.
Do I need to register if the ingredient has been registered by another company?
Yes. Cosmetic companies who want to utilize the same new ingredient are subject to separate registration now.
In the past once CFDA announced the approval of a NCI, all subsequent companies wishing to utilize the substance were permitted, despite the fact original registrants were likely to have invested extensive time and finances in both R&D and safety testing stages. The old policy has been complained as unfair to the applicant who has paid extensive efforts to gain the permit, which will ultimately hurt companies' initiative to do registration.
But, under the new management scheme, only companies that undertake full registration will be granted the “new cosmetic ingredient trial use certificate” (valid for 4 years) and entitled exclusively to utilize the new ingredient in their products. The move will grant significant protection for registrants of new cosmetics ingredients and ensure that costly financial investments are rewarded.
4 years' protection period for registrants
From 1 Jan 2014, CFDA will no longer release online announcements to approve new cosmetic ingredients but issue “new cosmetic ingredient trial use certificate” for the applicant only. The period of validity is four years, during which applicants can manufacture, sell and use this new ingredient. If no adverse events occur during the 4 years, the ingredient will be listed into the “inventory of existing cosmetic ingredients in China” (IECIC) allowing all cosmetics companies to freely utilize the substance. That is to say the applicant can enjoy the exclusive protection period of 4 years. It is noteworthy that on 21 Jan 2014 CFDA released a draft of IECIC (2014) containing 8641 cosmetic ingredients for use (CL news on 23 Jan 2014).
Data sharing?
The industry now is very concerned about whether data sharing is allowed for companies registering the same new ingredient. But the public consultation notice has not indicated CFDA's intention for data sharing. It is highly expected to be permitted to avoid duplication of animal tests.
Intensified post market surveillance
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.
Re-evaluation of approved new ingredients
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.
Mr. Martin Hu, the cosmetic regulatory expert from REACH24H, told ChemLinked that the adjustment is mainly aimed at protecting the interest of NCI applicants, encouraging innovation of the cosmetic industry and further tightening post-market management. But there is no indication of CFDA’s intention to lower technical requirements for registration of NCIs now. Cosmetics companies currently need to register their new ingredients according to the guidance document "Guidance on Application and Review of New Cosmetic Raw Materials". Nevertheless, CFDA stated that the revision of this guidance is already on the agenda.
The deadline for public consultation is 20 Feb 2014. Please send your comments to CFDA official's email:
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