On April 29, 2025, the National Institutes for Food and Drug Control (NIFDC) Releases Frequently Asked Questions (FAQs) on Technical Review of Cosmetics, we have collected the latest FAQs and translated them into English for your reference.
Q1: How Should the Safety Assessment Be Conducted for Cosmetic Products that Must Be Used in Conjunction with Instruments or Devices?
A: For cosmetic products that must be used in conjunction with instruments or devices (excluding tools solely for auxiliary application such as brushes, puffs, and perming tools), the mechanism of action of the instrument or device used in combination should be clearly defined, and the product’s safety under the conditions of use with such instruments or devices should be evaluated. The instruments or devices used in combination shall not possess cosmetic functions, shall not be involved in any reprocessing of the cosmetic product, and shall not alter the mode or mechanism of interaction between the cosmetic and the skin.
For cosmetics used in combination with instruments or devices, if the device affects the transdermal absorption of the product, the skin absorption rate of the ingredients should be adjusted accordingly during the safety assessment. In general, a more conservative percutaneous absorption rate should be adopted.
Q2: When Submitting a pH Test Report for Cosmetic Product Registration or Notification, How Should the pH Determination Method Be Selected?
A: According to the National Medical Products Administration (NMPA) Announcement on Including 21 Formulation and Revision Projects such as the pH Determination Method for Water-in-Oil (W/O) Cosmetics into the Safety and Technical Standards for Cosmetics (2015 Edition) (Announcement No. 41 of 2023), effective from August 28, 2023, the Safety and Technical Standards for Cosmetics (2015 Edition) (hereinafter referred to as the Technical Standards) includes two pH determination methods for cosmetics: “1.1 pH Value” and “1.10 pH Determination Method for Water-in-Oil (W/O) Cosmetics.”
For cosmetics requiring submission of a pH test report during the registration or notification process, the product formula should first be assessed to determine whether the product is a Water-in-Oil (W/O) type. If confirmed to be W/O, the pH value should be determined using the method specified in “1.10 pH Determination Method for Water-in-Oil (W/O) Cosmetics.” If the product is not of the W/O type, the method “1.1 pH Value” should be used, and it must be clearly indicated whether the direct measurement method or the dilution method was employed.
In the “Brief Description of Quality Control Measures” section of the product’s implementation standard, if the pH determination method from the Technical Standards is adopted, the name of the test method as specified in the Safety and Technical Standards for Cosmetics must be provided.
Q3: How Should the Safety Assessment Be Conducted for Cosmetics Comprising Two or More Components That Must Be Used in Combination?
A: For cosmetics consisting of two or more components that must be used together (e.g., hair dye products, cosmetics combining lyophilized powder and serum, etc.), the concentration of ingredients after mixing should be evaluated based on the product’s usage instructions.
If multiple mixing ratios may be used in actual application, the actual usage concentration of each ingredient under each ratio should be assessed accordingly. In addition, relevant literature or experimental study data should be used to evaluate the potential safety risks arising from any chemical and/or biological interactions between the ingredients.
Q4: How Should the Safety Assessment Be Conducted for Cosmetics That Must Be Used in Conjunction with Devices or Tools?
A: For cosmetics that must be used in conjunction with devices or tools (excluding simple application aids such as brushes, puffs, or hair styling tools), the mechanism of action of the associated device or tool must be clearly defined. The safety of the product under the conditions of use with the device or tool should be evaluated accordingly.
The accompanying device or tool must not possess cosmetic functions, must not participate in the reprocessing of the cosmetic product, and must not alter the mode of action or mechanism by which the cosmetic interacts with the skin.
For cosmetics used in combination with devices that may affect transdermal absorption, the ingredient absorption rate through the skin should be adjusted during the safety assessment. In general, a more conservative percutaneous absorption rate should be adopted.
Q5: How Should the Revised Test Method for 1,4-Dioxane in Cosmetics under the "Safety and Technical Standards for Cosmetics" Be Implemented?
A: According to the Announcement on Including 19 Projects such as General Principles for Sample Pretreatment in Toxicological Testing Methods of Cosmetics into the Safety and Technical Standards for Cosmetics (2015 Edition) (No. 12 of 2024) issued by the National Medical Products Administration (NMPA), for cosmetics that are required to submit a 1,4-dioxane test report during registration or notification, the test report must adopt the updated testing method specified in the announcement starting from December 1, 2024.
In the “Brief Description” section under “Quality Control Measures” of the product’s implementation standard, if the 1,4-dioxane testing method from the Safety and Technical Standards for Cosmetics is used, the revised method name must be indicated accordingly.
About CIRS
The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.
Cosmetic services in China:
- China Cosmetic Registration and Filing;
- China New Cosmetic Ingredient Registration and Filing;
- China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
- China Cosmetics Safety and Efficacy Test;
- China Cosmetic Safety Assessment Report;
- China Toothpaste Filing;
- China Disinfectant Notification; and
- China Cosmetic Formula/Label/Claim Review
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
