The recent China NMPA Cosmetics Suspension involves two products from Catalysis, Spain, illustrating the country’s stringent regulations regarding banned substances in cosmetics. The National Medical Products Administration (NMPA) announced on September 13, 2024, the suspension of Blue Cap Spray and Blue Cap Cream due to the detection of difluorasone propionate, a prohibited glucocorticoid.
This regulatory action emphasizes China’s commitment to ensuring the safety of cosmetic products and protecting public health. Difluorasone propionate is known for its powerful anti-inflammatory, anti-allergic, and skin-whitening properties. These effects may appeal to consumers looking for fast-acting cosmetic solutions; however, they pose significant risks. Prolonged use of products containing glucocorticoids can lead to serious skin conditions such as hormone-dependent dermatitis, dark spots, and even skin atrophy. Given these severe side effects, the use of difluorasone propionate in cosmetics is strictly regulated worldwide, with China imposing a complete ban on its inclusion in cosmetic formulations.
Examples on prohibited cosmetics ingredients listed by NMPA
The NMPA maintains a comprehensive list of prohibited ingredients, which includes over 1,000 substances. Here are a few examples: If you would like this list or specific advice about responding to NMPA inspections or other Chinese authority audit notices, or more general tips about best practices and frequently recurring overseas factory audit deficiencies, please contact us.
Implications and Recommendations
Cosmetics manufacturers with products registered in China, particularly in regulatory-sensitive markets, should take proactive measures to ensure compliance and protect their brand reputation. Here are some essential recommendations:
- Strengthen Regulatory Compliance
Manufacturers should regularly review and update their knowledge of China’s evolving regulatory landscape. This includes staying informed about prohibited substances, such as difluorasone propionate, and ensuring their product formulations are compliant with the Regulations on the Supervision and Administration of Cosmetics. A proactive compliance strategy will help avoid sudden suspensions or product recalls.
Action: Implement a dedicated team or hire consultants to track regulatory changes in China and conduct regular audits of ingredient lists against Chinese regulations.
- Enhance Quality Control and Raw Material Testing
Given the suspension of products due to the inclusion of banned ingredients, manufacturers should ensure rigorous testing of raw materials used in their cosmetics. In particular, focus on detecting prohibited substances like glucocorticoids through validated methods.
Action: Adopt supplementary testing methods, like those introduced by the NMPA in 2024, for substances like difluorasone propionate. This ensures that banned substances do not unintentionally enter the manufacturing process.
- Respond Swiftly to Non-Compliance Issues
If a product is found to be non-compliant, manufacturers should act quickly to address the issue. Swiftly removing the product from the market, conducting thorough investigations, and communicating transparently with authorities can mitigate long-term damage.
Action: Establish an internal task force for swift responses to regulatory violations, ensuring corrective actions are taken without delay.
Further information
Read the original announcement on China NMPA Cosmetics Suspension: Prohibition on Glucocorticoids in Catalysis Products from Spain.
Read our previous article on China prohibited cosmetic ingredient list update has been proposed.
Contact us to learn more about our cosmetics services in China.
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