China Approves the First New Whitening Ingredient Under CSAR Framework

Isobutylamido Thiazolyl Resorcinol is the first new cosmetic ingredient approved for registration by the NMPA under the CSAR framework, which serves as a milestone in ingredient innovation within the whitening cosmetics sector and driving the high-quality development of the sector.

On November 4, 2024, the National Medical Products Administration (NMPA) approved the registration of a new cosmetic ingredient, Isobutylamido Thiazolyl Resorcinol (Thiamidol 630), which was the first registered ingredient after the implementation of Cosmetic Supervision and Administration Regulation (CSAR) in 2021.

This new ingredient, synthesized through a chemical process, has undergone efficacy and safety verification by the registrant. It is approved for use as a whitening agent in leave-on cosmetics (excluding products that may pose inhalation risks). This approval offers a new opportunity for the development of freckle removal and whitening cosmetics in China. Additionally, it is expected to further stimulate the research and development efforts of cosmetic companies and drive innovation of cosmetic ingredients.

Compliance Requirements for New Cosmetic Ingredients (NCI) in China

To promote innovation in the cosmetics industry, the CSAR, implemented in 2021, replaced the previous approval system for new cosmetic ingredients with a registration and notification system based on risk levels. All new cosmetic ingredients shall be either registered or notified with the NMPA before being used in cosmetic products.

Under this system, high-risk NCIs such as preservatives, UV filters, colorants, hair dyes, and freckle removal or whitening agents require comprehensive registration and approval from the NMPA, including format review and technical review, while other ingredients are subject to less rigorous regulatory framework - notification.

When applying for high-risk ingredients, including whitening agents, the oversee registrant shall authorize a Chinese enterprise as the responsible person (RP) and submit the required documents as specified in Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers to the NMPA. The NMPA will review the application and make decisions. If approved, a registration certificate will be issued, and the information will be made public within 5 working days. For more detailed information, please refer to the China New Cosmetic Ingredient (NCI) Regulation.

REACH24H Consulting Group, the founder of ChemLinked, as a third-party compliance service provider, assisted Beiersdorf Group in successfully obtaining the registration approval. If you have any compliance needs regarding new cosmetic ingredient notification or registration, please contact us at cosmetic@chemlinked.com.