ZMUni Compliance Centre

On January 12, 2025, China's National Medical Products Administration (NMPA) issued a new supplementary testing method: BJH 202502 Determination of Sudan I (CI 12055) and Other 3 Kinds of Ingredients in Cosmetic. 

This method specifies the determination of Sudan I (CI 12055), Sudan II (CI 12140), Sudan III (CI 26100), and Sudan IV (CI 26105) in cosmetic products. It is applicable to the quantitative determination of these dyes in liquid (aqueous and oil-based), cream/ointment, powder, solid, and wax-based cosmetic formulations.

The release follows the October 2025 Sudan red incident, when several skincare products from major brands tested positive for Sudan red—a substance banned in China for nearly 20 years—challenging the prevailing belief that violations occurred only in color cosmetics.

At the time, China's testing methods were limited to color cosmetics. While the incident attracted nationwide attention, the lack of applicable standards prevented confirmation, and regulatory authorities did not issue an official statement. The matter concluded in November 2025, when the health authorities in China Taiwan reported Sudan red in imported raw materials of a cosmetic brand. Industry observers noted that the absence of standardized testing methods contributed to the cautious handling of the case.

The new supplementary testing method fills the gap for skincare products, enhances analytical standards, and provides a clear basis for sampling, enforcement, and quality investigations of Sudan red in China.