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China Consults on Two Guidelines for Determining New Cosmetic Ingredients (NCIs)

China NIFDC is inviting public input regarding the Guidelines for Research and Determination of the Safe Use History of New Cosmetic Ingredients (Trial) (Draft for Comments) and the Guidelines for Research and Determination of the Safe Consumption History of New Cosmetic Ingredients (Trial) (Draft for Comments). These draft guidelines are designed to standardize the research and evaluation processes of NCIs, and guide the collection, determination, and application of relevant materials on the safe use history and safe consumption history of NCIs in safety assessment.

Background

Under the existing Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers, new cosmetic ingredients (NCIs) are classified into six distinct situations based on their functions, traits, history of use or consumption in cosmetics at home and abroad, etc., each with different testing requirements.

6-situations.jpgNCI Situation Classification and Testing RequirementsAmong them, NCIs with safe usage history exceeding three years in cosmetics marketed overseas (Situation 3 and 4), and NCIs with safe consumption history (Situation 5) can be exempt from certain toxicological tests, as their safe consumption history and/or safe use history can, to a certain extent, illustrate the safety of the NCIs.


However, due to the lack of specific rules, registrants and notifiers of NCIs are sometimes confused when submitting relevant dossiers. Issues such as unclear determination of ingredient attributes, insufficient submission of materials, the unqualified certification or publishing agencies of the source of the safe consumption /use history data, and uneven quality of safety assessments have been observed during the technical review process.

NCI Determining Criteria

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