Applicants for the registration or notification of new cosmetic ingredients (hereinafter referred to as "applicants") shall conduct a consistency analysis of the ingredient based on its source, manufacturing process, composition, and quality specifications.
For new ingredients with a clearly defined single chemical structure, key information such as molecular formula and structural formula must be consistent. If modifications to the manufacturing process are made-for example, to improve ingredient quality or enhance environmental sustainability-a comprehensive analysis must be conducted to assess any resulting changes in ingredient content (purity), impurity profile, and other potentially affected characteristics. For other types of new ingredients, such as plant extracts, microbial fermentation products, and polymeric substances, it is essential to ensure that the ingredient referenced in the safety use history documentation is consistent with the new ingredient intended for registration or notification.
In addition, if the ingredient is actually marketed in a compound (mixture) form, the potential impact of other components in the mixture on efficacy and safety must be analyzed. The scientific validity of using the historical safety data as the basis for the safety assessment of the new ingredient should be thoroughly evaluated.