China New Cosmetic Ingredient Registration and Filing

Under Cosmetics Supervision and Administration Regulations (CSAR) issued in 2020, companies shall apply for the registration and filing of cosmetic ingredients not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021). New cosmetic ingredients refer to natural or artificial raw materials used in cosmetics for the first time in China.

Type of New Cosmetic Ingredients

New cosmetic ingredients with high safety risk(s): preservatives, colorants, anti-freckle/whitening agents, sunscreen agents, and hair dyes
New cosmetic ingredients without high safety risk(s)

If the use purpose or maximum use level is changed for the approved or filed new cosmetic ingredients, new application for the registration or filing will be required.

Companies in China can apply for the registration or filing of new cosmetic ingredient directly or appoint a local agent as a technical provider to do so. Foreign companies must appoint a domestic responsible person to apply for the registration or filing of new cosmetic ingredient. The registrant or filer shall be responsible for the quality and safety of new cosmetic ingredients.

Application Types

There are two types of application for new cosmetic ingredients under CSAR: registration and filing.

Registration：

New cosmetic ingredients with high safety risk as the function of preservative, colorant, hair dye, whitening/anti-freckle, sunscreen.
Approval license will be issued once passing both the format and
technical review of NMPA.
Filing：
Other cosmetic ingredients without high safety risk.
Generally, the electronic filing certificate will be issued if passing
the format review of submitted dossiers by NMPA.

Application Process

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New Cosmetic Ingredient Registration and Filing：

ID application
Data evaluation and gap analysis;
Testing coordination;
Preparation of safety assessment report;
Dossier preparation and submission;
Technical translation Post-notification Maintenance :
Annual report during the 3 years of safety monitoring period
Trade/manufacture activities of the approved
or filed new cosmetic ingredient
Its use info in cosmetics
Surveillance sampling, investigation and recall
info of cosmetics using the new cosmetic ingredients
Adverse reaction monitoring
Risk monitoring and evaluation management

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