In 2020, the Cosmetics Supervision and Administration Regulations (CSAR) introduced new guidelines for the registration and filing of cosmetic ingredients that are not listed in the official Inventory of Existing Cosmetic Ingredients in China (IECIC 2021). New cosmetic ingredients refer to raw materials—whether natural or synthetic—that are being used for the first time in cosmetic products in China.

Classification of New Cosmetic Ingredients

• High-risk ingredients: These include preservatives, colorants, whitening/anti-freckle agents, sunscreens, and hair dyes. These ingredients are subject to stricter regulatory requirements due to their higher potential safety risks.
• Low-risk ingredients: These ingredients do not pose significant safety concerns and are typically subject to less rigorous regulatory procedures.

Types of Applications

Under the CSAR, new cosmetic ingredients require either registration or filing, depending on the risk profile of the ingredient. Below are the details for each type of application:

If there is any change in the intended use or maximum allowable concentration for a registered or filed ingredient, a new application for either registration or filing will be necessary.

Companies based in China can directly apply for registration or filing. Foreign companies, however, must appoint a domestic responsible party in China to handle the registration or filing process for new cosmetic ingredients. The registrant or filer is ultimately responsible for the quality and safety of the ingredients placed in the market.

Responsibilities of the Domestic Responsible Person

• Submit the registration or filing of new cosmetic ingredients on behalf of the registrant or filer;

• Assist in safety monitoring and reporting adverse reactions related to new cosmetic ingredients;

• Support in recalling cosmetic ingredients when necessary;

• Assume safety and quality responsibilities as per the agreement between the responsible person and registrant/filer;

• Collaborate with regulatory authorities for inspections and supervision tasks.

Application Process

Who Needs to Register?

Post-market Surveillance

Once the registration or filing process is completed, the safety monitoring system for the new cosmetic ingredient will be activated. The safety monitoring period lasts for 3 years from the date when the cosmetic ingredient is used in a product for the first time. During this time, the registrant or filer can use the new ingredient to manufacture cosmetics.

After the 3-year monitoring period, the NMPA will evaluate the safety of the ingredient. If no safety concerns are found, the ingredient will be added to the IECIC list. If issues are detected, the registration license or filing certificate may be revoked.

Our Services

CIRS China offers a comprehensive range of services to ensure compliance with the new cosmetic ingredient regulations in China.

Our services include: