ZMUni Compliance Centre

On June 24, 2025, China National Institute for Food and Drug Control (NIFDC) released two guidelines for new cosmetic ingredients, including:

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

Applicable NCI notification situations: situation 3 & situation 4, referring to ingredients that can provide sufficient evidence of having been safely used in marketed cosmetics for more than three years.

Key Highlights:

• If the marketed cosmetic is not manufactured by the NCI registrant or notifier, the source of information must be clarified and proper authorization obtained.

• Continuous sales of the same product for at least 3 years can now be accepted as supporting evidence.

• The quantitative requirement remains unchanged:

A minimum of 10,000 units sold over 3 years, with no fewer than 3,000 units per year.

If using indirect sales data (e.g., factory shipment volume or distributor sales volume), the threshold is higher: 100,000 units over 3 years, with no fewer than 30,000 units per year.

• The previously required data on long-term (1 year or more) continuous use by no fewer than 100 consumers is now only required for whitening/spot-lightening NCIs.(i.e., Situation 1).

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

Applicable NCI notification situations: situation 5, referring to ingredients with a proven history of safe consumption.

Key Highlights:

• Examples of qualified institutions for species identification (e.g., plants) —such as research institutes and universities—have been included.

• Safety assessment requirements are now more specific: if historical edible use data lacks defined intake limits, an analysis based on typical consumption levels is required.

• It is explicitly stated that ingredients with higher safety risks or disputed edible safety must undergo comprehensive toxicological evaluations.

• The acceptable sources for documenting edible use history have been clarified, including ingredient lists published by Chinese authorities—such as general food ingredients, regionally characteristic foods, new food ingredients, substances used in both food and medicine, and health food ingredients.

• For ingredients with whitening or spot-lightening functions, edible use history can only serve to waive certain systemic toxicity tests. It does not eliminate the need to evaluate the safety risks associated with long-term topical application on human skin.

These documents aim to implement the Several Provisions on Supporting Cosmetic Ingredient Innovation and strengthen technical guidance on the determination and classification of application situations for new cosmetic ingredient.

Previously, on May 31, 2024, the NIFDC had solicited public comments on draft versions of these two guidelines.