For ingredients with clearly defined intake limits or other restrictions in food use, safety assessments for cosmetic applications should be conducted based on factors such as the intended scope of use, safe usage levels, and applicable conditions for the new ingredient. For ingredients without explicitly defined intake limits, a reasonable assessment may be conducted by taking into account dietary habits, typical consumption levels, and other relevant information. If the raw material has undergone further processing-such as being used in the form of a plant extract-appropriate conversion calculations should be considered during the assessment.
If the established intake limits or typical consumption levels are insufficient to support the intended use of the new ingredient in cosmetics, additional data-such as repeated dose toxicity study results and other necessary information-should be provided to assess the ingredient’s scope of application and safe usage levels. A complete and standardized toxicological study report must be submitted concurrently.
In addition, the history of safe consumption is primarily used to support the waiver of systemic toxicity-related studies. However, for new ingredients with skin-whitening or spot-removal functions, the potential safety risks associated with long-term application to human skin cannot be ruled out. Therefore, relevant data or additional studies should be provided to ensure safety.