I. Can the basic conclusion of a safety assessment still be submitted after May 1, 2025?

After May 1, 2025, eligible general cosmetics may still submit the basic conclusion of a safety assessment. According to the "Announcement on Several Measures to Optimize the Management of Cosmetic Safety Assessments" (No. 50 [2024]) issued by the National Medical Products Administration (NMPA) and the "Guidelines for Submitting Cosmetic Safety Assessment Materials," the NMPA implements categorized management of cosmetic safety assessment materials. This allows some eligible general cosmetics to submit the basic conclusion of the safety assessment, while the full safety assessment report is to be archived by the cosmetics company for future reference.

II. Can the full version of the safety assessment report use the maximum historical usage levels from the "Inventory of Used Cosmetic Ingredients" (2021 edition) as the basis for assessment?

The "Guidelines for the Use of Cosmetic Ingredient Data" (hereinafter referred to as the "Guidelines") do not include the maximum historical usage levels of ingredients published by cosmetic regulatory authorities as a reference basis for assessment. According to the "Guidelines," the main types of ingredient data include:

1. Restricted components, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes listed in the "Cosmetic Safety Technical Specifications."

2. Assessment conclusions published by internationally authoritative cosmetic safety assessment institutions.

3. Safety limits or conclusions published by authoritative organizations such as the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations.

4. Usage information of ingredients in marketed products published by regulatory authorities.

5. Three-year usage history of ingredients.

6. History of safe consumption.

7. Structurally and chemically stable high-molecular-weight polymers (excluding ingredients with high biological activity).

   
   

III. How to provide supporting materials for risk substance assessment?

The submitted materials should clearly indicate the source of regulations or literature and include key content such as the assessed safe dosage of the risk substance. If the materials provided are in a foreign language, the entire foreign-language content must be translated into Chinese.

IV. How to conduct a safety assessment for fragrances?

The term "fragrance" listed in the "Inventory of Used Cosmetic Ingredients" refers to a general category of ingredients. Proof documents demonstrating that the fragrance used in the product complies with the International Fragrance Association (IFRA) Practice Code or relevant Chinese national standards must be provided as the basis for assessment.

If both "fragrance" and specific fragrance components are listed in the product formulation table, the manufacturer of the fragrance ingredient must provide documentation detailing all fragrance components and their concentrations in the fragrance. A safety assessment must then be conducted for each fragrance component.

If ingredients such as lavender (LAVANDULA HYBRIDA) oil or rose (ROSA RUGOSA) flower oil are directly listed in the product formulation as fragrances, they should be assessed as ordinary ingredients.

V. Can recommended national or industry standards, which set relatively broad pH value ranges for product categories such as facial cleansers, skin lotions, and hair perm agents, be directly referenced when establishing the pH control range for specific products?

To ensure broad applicability, recommended national or industry standards for related cosmetic categories set relatively wide pH value ranges, some of which may span both acidic and alkaline regions or even reach strongly acidic or alkaline levels. When establishing the pH control range for a specific product, companies should determine a range that reflects the product's safety control indicators based on factors such as the product formulation, production process, and usage methods. It is not advisable to directly adopt the pH value ranges set in recommended national or industry standards.