China New Cosmetic Ingredients Registration and Filing - Cosmetics and Daily Care Products

Under China's Cosmetics Supervision and Administration Regulations (CSAR) issued in 2020, companies must register or file any cosmetic ingredients not listed in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021). New cosmetic ingredients refer to natural or synthetic raw materials being used in cosmetics in China for the first time.

Type of New Cosmetic Ingredients

High safety risk(s): Preservatives, colorants, anti-freckle/whitening agents, sunscreen agents, and hair dyes

Other new cosmetic ingredients: Those considered low or moderate risk without the function listed above.

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, and sunscreen. An approval license is issued after passing both the format and technical review of the NMPA.
Filing	Required for other cosmetic ingredients without high safety risk. Generally, the electronic filing certificate will be issued after passing the format review of submitted dossiers by NMPA.

If the use or maximum concentration of a registered or filed ingredient changes, a new application will be required.

Who can apply?

Chinese companies can apply directly or appoint a local agent as a technical provider.
Foreign companies must appoint a Domestic Responsible Person (DRP) in China to apply for the registration or filing of the new cosmetic ingredient and be responsible for the quality and safety.

Duties of the Domestic Responsible Person

Submit and maintain registration or filing of the new cosmetic ingredients on behalf of the applicant;
Assist with post-market safety monitoring and adverse event reporting;
Assist registrants and filers in the recall of cosmetic ingredients;
Support product recalls cooperate with inspections by authorities; and
According to the agreement between the responsible person and registrant/filer, share safety and quality responsibilities of new cosmetic ingredients placed on the Chinese market.

Application Process

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Who Should Register?

Manufacturers of new cosmetic ingredients;
Manufacturers or brand owners of cosmetics using new cosmetic ingredients

Post-market surveillance

Registered or filed ingredients are subject to a three-year safety monitoring period starting from the first use in a cosmetic product.

During this period registrants or filers can use the approved or filed new cosmetic ingredient to produce cosmetics and must submit annual safety reports. After three years, the NMPA evaluates safety data – if no issues arise, the ingredient will be added to IECIC. Otherwise, the approval will be revoked.

Our Services

CIRS Testing provides a complete one-stop solution to support compliance with China's cosmetic ingredient regulations.

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 and communication with authorities
Post-notification Maintenance	Annual report during the 3-year safety monitoring period Ongoing compliance tracking for trade and manufacturing Surveillance sampling, investigation, and recall information of cosmetics using the new cosmetic ingredients Adverse reaction monitoring Risk monitoring and evaluation management

Contact Us

For tailored guidance on new cosmetic ingredient registration or filing in China, contact our experts at cosmetic-ck@cirs-group.com.