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.

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Analysis on the Filing of New Cosmetic Ingredients 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)

Application Types

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

Registration	New cosmetic ingredients with high safety risks as the function of preservatives, colorants, hair dyes, whitening/anti-freckle, and 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.

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

Companies in China can apply for the registration or filing of new cosmetic ingredients 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.

Duty of Domestic Responsible Person

• Register and file the new cosmetic ingredients in the name of the registrant and filer;

• Assist registrants and filers in the safety monitoring and reporting of new cosmetic raw materials;

• Assist registrants and filers in the recall of cosmetic ingredients

• According to the agreement between the responsible person and registrant/filer, undertaking the corresponding safety and quality responsibilities of new cosmetic ingredients placed in the Chinese market;

• Cooperate with the supervision and inspection work of the supervision departments.

Application Process

Who Shall Register?

• Manufacturers of new cosmetic ingredients;

• Manufacturers or brand owners of cosmetics using new cosmetic ingredients

Post-market surveillance

After registration or filing, the safety monitoring system will be available for the approved or filed new cosmetic ingredients. The period of safety monitoring is 3 years from the date of completing the registration or filing of cosmetics using the approved or filed new cosmetic ingredient for the first time. During the period of safety monitoring, new cosmetic ingredient registrant or filer can use the approved or filed new cosmetic ingredient to produce cosmetics. After the 3 years of the safety monitoring period, NMPA will carry out the safety evaluation for the approved or filed new cosmetic ingredients, if there is no safety issue, the approved or filed new cosmetic ingredients will be added to the IECIC list. Otherwise, the registration license or filing number will be canceled.

Our Services

CIRS China can provide all the necessary services in one package to comply with the new cosmetics regulations in China for the management of new cosmetic ingredients.

Our services include:

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 the safety monitoring period Trade/manufacturing 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