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Analyzing the Main Reasons Behind the Deregistration of New Cosmetic Ingredients

from CIRS by

China,Cosmetic,New,Ingredient,Deregistration,Reason

According to inquiries with China's National Medical Products Administration (NMPA), five NMPA numbers have been deregistered this year. The possible reasons for deregistering newly registered ingredients include:

- Non-compliance with the definition of new ingredients: Some ingredients were registered, but in reality, they are already being used and managed as cosmetic ingredients, and are no longer considered new.

- Functions exceeding the scope of cosmetics: Some ingredients have medicinal or other functions that go beyond the definition of cosmetics.

- Re-registration: The registrant may have re-submitted an application to improve the information, and thus deregistered the historical NMPA numbers that were not referenced during the cosmetic product registration process.

The Guidelines for Cosmetic and New Ingredient Registration and Approval state that, after the registration of new cosmetic ingredients is completed, the Medical regulatory authorities will organize technical review institutions to conduct a technical verification of the registered data. They will also track and assess the usage and safety of the new cosmetic ingredients. If it is found that the registered data of the new cosmetic ingredients do not meet the requirements, the registrant will be ordered to make corrections within a specified time. If the safety-related data does not meet the requirements, the authorities may simultaneously order the suspension of the sale and use of the new ingredients. If it is found that the new cosmetic ingredients do not fall within the registration scope, or if false information was submitted during the registration, the registration will be canceled. If the new cosmetic ingredients are ordered to be suspended or the registration is canceled, the registrants must simultaneously suspend or stop the production and sale of any cosmetics using those ingredients.

To ensure the stability, safety, and controllability of cosmetics, the Regulations on the Management of Registration and Filing Data for New Cosmetic Ingredients stipulate that there is a 3-year monitoring period after the registration of new ingredients. After this period, it will be decided whether the new ingredient should be included in the catalog of permitted ingredients. Therefore, completing the registration of a new cosmetic ingredient does not mean that its safety and functionality have been recognized. Only new cosmetic ingredients that have been fully validated and have not caused any safety issues during the 3-year period are eligible to be included in the catalog of permitted cosmetic ingredients.

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