On November 4, 2024, the National Medical Products Administration (NMPA) approved Isobutylamido Thiazolyl Resorcinol (Thiamidol 630) as the first new whitening cosmetic ingredient registered under China’s Cosmetic Supervision and Administration Regulation (CSAR), marking a significant milestone in the cosmetic industry. This approval represents a breakthrough in ingredient innovation, driving high-quality development in the whitening cosmetics sector.

Isobutylamido Thiazolyl Resorcinol, synthesized through a chemical process, has undergone thorough efficacy and safety assessments by the registrant. Approved for use in leave-on cosmetics (excluding products that may pose inhalation risks), it opens new opportunities for the development of freckle removal and skin-whitening products in China. This milestone is expected to inspire further research and drive ingredient innovation across the industry.

Compliance Requirements for New Cosmetic Ingredients in China

The CSAR framework, effective since 2021, established a risk-based registration and notification system to promote innovation in the cosmetics industry. High-risk new cosmetic ingredients (NCIs)—such as preservatives, UV filters, colorants, hair dyes, and whitening agents—must undergo comprehensive registration and approval from the NMPA, involving format and technical reviews. Lower-risk ingredients follow a simpler notification process.

Registrants of high-risk ingredients, like whitening agents, must authorize a Chinese enterprise as the Responsible Person (RP) to submit the required documents per the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. Upon approval, a registration certificate is issued, and details are published within five working days.

Reference links:

• China Cosmetic Product Registration/Notification
• China New Cosmetic Ingredients Registration/Notification
• China’s Cosmetic Ingredient Submission Code
• Efficacy Claim Evaluation Report
• China Toothpaste Notification

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News Source: ChemLinked

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