A new supplementary testing method for 16alpha-hydroxiprednisolone in cosmetics issued by NMPA in China

On 23 November 2022, the National Medical Products Administration (NMPA) in China released a new supplementary test method ‘BHJ 202203 Determination of 16alpha-hydroxiprednisolone in Cosmetics’. The test specifies the qualitative and quantitative determination method of the ingredient 16alpha-hydroxyprednisolone in creams, lotions, and liquid cosmetics.

16alpha-hydroxyprednisolone (CAS number of 13951-70-7), is used in the production of steroids such as budesonide and ciclesonide.  According to the EU classification, prolonged or repeated exposure to the substance can cause skin sensitization reactions, impair the fertility of unborn babies, and cause harm to breastfed children. It is banned for use in cosmetics in China.

BJH 202203 is a supplementary test that is a supplement to the conventional test methods specified in the national cosmetic standards and technical specifications. The supplementary tests are established for banned ingredients in cosmetics that lack testing methods and are used in adulterated products. Supplementary testing methods are important for regulators and law enforcement inspecting cosmetics post-market especially when combatting illegal additions.

For further information about the NMPA supplementary tests check the following links:.

• NMPA supplementary tests, 2021 (in English)
• NMPA supplementary test method for 16α-hydroxyprednisolone in cosmetic products (Mandarin)

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