FAQs Vol. 19 | China Answers Questions about Cosmetic Safety Assessment Requirements

According to the Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management (No.50 of 2024), registrants and notifiers of part of eligible general cosmetics are allowed to submit basic safety assessment conclusions, and the safety assessment report should be archived by the cosmetic enterprise. Before May 1, 2025, cosmetic registrants and notifiers can still submit the simplified version of the safety assessment report when applying for registration or notification.

Archiving safety assessment reports for future inspections is an innovative measure for enterprises to implement their primary responsibility and reduce their workload of submitting dossiers during the cosmetics registration and notification process. It is not an exemption for enterprises from preparing a cosmetic safety assessment report or a reduction of requirements for product safety assessments.

Enterprises shall complete safety assessment and the formulation of the corresponding report prior to registration or notification. They may refer to the Self-inspection Points for Cosmetics Safety Assessment Reports (the“Self-Inspection Points”) to complete self-inspections and then only submit the basic safety assessment conclusion as per Guidelines for Submission of Cosmetics Safety Assessment Dossiers. Enterprises will be punished by related supervision departments if problems are found during the inspection in accordance with the law.

There are two major differences between the full and simplified version:

i. The full version includes an evaluation of both physical and chemical stability of the product (mainly encompassing the evaluation of product stability and compatibility with packaging materials), as well as microbiological evaluation (i.e., preservative challenge tests). According to the Guidelines for Submission of Cosmetics Safety Assessment Dossiers, enterprises are encouraged to conduct pertinent studies on product stability, preservative systems, package compatibility, etc., in accordance with national standards, international standards, technical guidelines or enterprise’s own methodology. The corresponding test results or assessment conclusions should be included in the safety assessment report.

ii. In the full version of the safety assessment report, the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC) is not considered as a type of evidence anymore, although it is still used as one of the evidences in the simplified version of the report.

According to the Guidelines for Submission of Cosmetics Safety Assessment Dossiers, after thorough research on ingredients, if enterprises cannot use any data type in the Guidelines for Use of Cosmetic Ingredient Data for safety assessment and the product meet all the following three conditions, enterprises are allowed to conduct the safety test for the product by referring to the toxicological test items and/or human body test items outlined in the Working Rules for Cosmetic Registration and Filling Testing (when meeting ethical requirements) for a comprehensive evaluation and analysis of the safety of the final product:

i. The ingredients are non-special function ingredients.

ii. The safety assessment cannot be completed only due to the lack of some toxicological endpoint assessment data.

iii. The non-special function ingredients whose safety assessment cannot be done by using any data type in the Guidelines for Use of Cosmetic Ingredient Data do not exceed 10% of the total number of ingredients in the formulation, and the non-special function ingredients are at a low concentration.

The structures and functions of different ingredients vary significantly. For example, some ingredients may have a little even no effect on human body at a concentration of 0.1%, posing low safety risks. However, certain ingredients that affect human body may pose safety risks even at a concentration of 0.01%. Therefore, registrants, notifiers, and safety assessors need to make comprehensive judgments on the “low concentration” of ingredients based on factors such as the structure, physio-chemical properties of the ingredients, product type, application area, and usage methods.

The Ingredient Usage Information of Marketed Products (hereinafter referred to as the “Ingredient Information”) is an objective collection of ingredients in special cosmetics within valid registration certificate in China, which have not been included in the Safety and Technical Standards for Cosmetics (STSC), nor have been assessed by authoritative international safety assessment institutions. The Ingredient Information can serve as a reference for the safety assessment of cosmetic products.

There are two principles when referring to the Ingredient Information.

i. For the same ingredient applied on the same area, if the ingredient has a recorded use amount in leave-on products, it can be used as a reference for rinse-off products.

ii. For the same ingredient used in the same way but applied to different areas, the use amount can be referenced following two orders: (I) whole body skin, trunk, face, lips, and eyes, and (II) whole body skin, trunk, hands and feet, head, and hair. The use amount of ingredient for the former areas can serve as a reference for later areas. However, when the product is applied for eyes and the use amount for other areas is referenced, the ingredient must be assessed for eye irritation separately. 

The following examples are provided to facilitate better use of Ingredient Information in the industry:

Example 1: How to use the Ingredient Information for rinse-off hair products?

For rinse-off hair products, the use amount provided in Ingredient Information can be used directly. If the use amount is not provided in Ingredient Information, the ingredient data for leave-on hair products can be referenced based on the first principle. If there is no ingredient data for leave-on hair products, the use amount of the ingredient in whole body skin, trunk area, hands and feet, or head can be adopted according to the second principle.

Example 2: How to use the Ingredient Information for leave-on eye products? 

For leave-on eye products, the use amount provided in Ingredient Information can be used directly without the need to assess eye irritation. If the use amount is not provided in Ingredient Information, the ingredient usage information for whole body skin, trunk area, face and lips can be adopted. Besides, the ingredient shall be assessed for eye irritation assessment separately.

Example 3: How to use the Ingredient Information for a product for application on two or more areas?

The use amount of the ingredient in a product for application on two or more areas can follow the second principle. For example, the use amount of the ingredient in a leave-on product for both the trunk and the face can be based on the data of a leave-on product for whole body skin. If the use amount is not provided in Ingredient Information, a safety assessment is required as per the Technical Guidelines for Cosmetic Safety Assessment (2021), or other types of ingredient data should be adopted as per Guidelines for Use of Cosmetic Ingredient Data.