The marketed cosmetics referenced in safety use history documentation must fall within the scope of the definition of cosmetics under Chinese regulations. If a product is not regulated as a cosmetic in its country of origin but meets the definition of a cosmetic under Chinese law, relevant information must be provided, including the regulatory context in the country of origin, applicable regulatory requirements, product claims, and mechanisms of action. An analysis should also be conducted to demonstrate how the product aligns with the definition of cosmetics in China. Furthermore, the concentration of the ingredient in the marketed product, its site of application, and method of use should be sufficient to support the applicable scope, usage conditions, and safe use levels as indicated in the registration or notification dossier.
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