China Clarifies Requirements for Proof Materials on the Safe Use and Consumption History of New Cosmetic Ingredients

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.

NCI 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.

On May 31, 2024, the China National Institutes for Food and Drug Control (NIFDC) released the draft Guidelines for the Research and Determination of the Safe Use History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the "Safe Use History Guidelines") and the draft Guidelines for the Research and Determination of the Safe Consumption History of New Cosmetic Ingredients (Trial) (hereinafter referred to as the "Safe Consumption History Guidelines"). ¹

Subsequently, on June 24, 2025, NIFDC officially issued and implemented the finalized versions of the Safe Use History Guidelines and the Safe Consumption History Guidelines ², along with corresponding Q&A. ³⁴

Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial)

The Safe Use History Guidelines is applicable to the research and determination of the safe use history of NCIs in Situation 3 and Situation 4. It mainly outlines the overview, application scope, general principles, basic requirements for safe use history proof materials, proof material format requirements, and safety assessment requirements. Key points include: