FAQs Vol. 26 | China NIFDC Answers Questions on Cosmetic Notification/Registration and Safety Assessment

According to the Amendments to Safety and Technical Standards for Cosmetics 2015 (NMPA No. 41 of 2023), effective from August 28, 2023, the Safety and Technical Standards for Cosmetics 2015 (STSC) has included two methods for determining the pH of cosmetics: “1.1 pH Value Determination Method” and “1.10 pH Determination Method for Water-in-Oil Cosmetics.”

For cosmetics subject to pH test report for registration or notification, the product should first be assessed based on its formulation, for the determination of  whether it is of the water-in-oil (W/O) type.

• If the product is confirmed to be water-in-oil, the pH should be measured according to “1.10 pH Determination Method for Water-in-Oil Cosmetics”.

• If the product is not a water-in-oil type, the “1.1 pH Value Determination Method" should be used, with a clear indication of the actual determination method, i.e., the direct measurement method or dilution method.

Besides, in the “Brief Description” section of the “Quality Control Measures” of the product executive standard, if the pH determination method from the STSC is adopted, the name of the determination method, as listed in the STSC, should be clearly stated.

Based on product characteristics, preservative efficacy evaluation is not required for cosmetic products insusceptible to microbial contamination. However, relevant circumstances for such products should be clearly explained. These include:

• Non-aqueous products

• Products primarily containing organic solvents

• Aqueous products with specific conditions, such as those with water activity

• Disposable products or products with non-reopenable packaging

According to Notice of the NMPA on Incorporating 19 Formulation and Revision Projects including the “General Rule for Pretreatment of Cosmetic in Toxicological Experiments” into the “Safety and Technical Standards for Cosmetics 2015” (No. 12, 2024):

• For cosmetics subject to dioxane test reports during registration and notification, effective from December 1, 2024, the revised dioxane test method outlined in the notice should be adopted.

• When the dioxane test method from the STSC is applied, the name of the revised test should be specified in the “Brief Description” section under “Quality Control Measures” of the product executive standard.

For cosmetics combining two or more doses that should be used successively (such as hair dye products, or cosmetics that combine freeze-dried powder and essence, etc.), the ingredient concentrations during the combined use of more than one doses of the product should be evaluated based on the intended usage method.

If the product allows for variable mixing ratios during actual use, the actual ingredients usage levels under each possible ratio must be evaluated separately. Additionally, potential safety risks arising from chemical and/or biological interactions between the ingredients should be assessed with the support by relevant literature or experimental research data on the product.

For cosmetics intended to be used with instruments or tools (excluding auxiliary applicators like brushes, air cushions, perming tools, etc.), the mechanism of the instruments or tools should be clearly defined. The product safety must be assessed when these instruments or tools are used. Besides, these instruments or tools should not possess cosmetic functions, participate in the reproduction process of the cosmetic product, or alter the mode and/or mechanism of interaction between the cosmetic and the skin.

If the instrument affects the transdermal absorption of the product, the skin absorption rate of the ingredients should be adjusted during the safety assessment. Generally, a more conservative transdermal absorption rate should be chosen.