Regulatory FAQs: Ordinary Cosmetics Filing in China (Vol.7)

Recently, the Beijing Cosmetics Review and Inspection Center has published a series of Q&A regarding ordinary cosmetics filing. The following content is primarily excerpted from the 53rd issue, compiled by CIRS Group for reference.

Question 1: What are the main scenarios for new ingredient filing information updates as stipulated in the "Technical Guidelines for Updating New Cosmetic Ingredient Filing Information"?

Answer: They are mainly divided into three categories: The first category is self-maintained information updates; the second category is enterprise information updates, including updating filer/domestic responsible person information (no change in the entity), updating manufacturer information (no change in production site), replacing the filer, replacing the domestic responsible person. In such cases, the actual production and research materials of the new ingredient have not changed; The third category is new ingredient information updates, including updating basic ingredient information, changing/adding production sites, adding/adjusting brief descriptions of production processes, updating quality control standards, extending usage period, adjusting usage purpose, updating precautions/warning language, etc. Except for self-maintained information, other information updates should have sufficient reasons, submit proposed updates according to procedures, and provide relevant materials as required.

In addition to the three categories mentioned above, information updates for new ingredients under other circumstances are generally not allowed. If updates are indeed necessary, the new ingredient filer should apply to conduct communication and exchange with the technical review institution to confirm the rationality, necessity, and scientific nature of the information update.

Question 2: What information can be updated within 1 month before the expiration of the new ingredient monitoring period as stipulated in the "Technical Guidelines for Updating New Cosmetic Ingredient Filing Information"?

Answer: Within 1 month before the expiration of the new ingredient monitoring period, except for self-maintained information updates and enterprise information updates, no other information updates are allowed in principle. If the new ingredient filer discovers substantial safety risks of the new ingredient in subsequent research, they shall not arbitrarily change relevant information, but shall timely report and take risk control measures in accordance with relevant requirements such as the "Regulations on the Supervision and Administration of Cosmetics" and the "Measures for the Administration of Cosmetic Registration and Filing."

Question 3: What are the submission channels for new ingredient information update materials?

Answer: The new ingredient filer shall submit relevant information materials in the corresponding module for new ingredient information updates through the "Enterprise Information Data Management System" or the "Cosmetic Smart Declaration and Review System" in the cosmetic information service platform. The filer shall not submit update matters and relevant materials through channels such as new ingredient annual reports, risk control reports, or ordered correction materials.

According to technical review opinions after filing, if adjustments to the content of new ingredient materials are required, relevant material content can be adjusted and improved in the ordered correction materials.

Question 4: Can the ingredient usage purpose not within the scope of the "Catalog of Cosmetic Ingredient Usage Purposes" be declared?

Answer: When registering or filing cosmetics or new ingredients, priority should be given to selecting ingredient usage purposes from the "Catalog of Cosmetic Ingredient Usage Purposes" in principle. Considering the actual needs of industry innovation development and regulatory work, if the ingredient usage purpose is indeed not within the scope of the "Catalog of Cosmetic Ingredient Usage Purposes," "other usage purposes" can be declared, and relevant supporting materials shall be provided at the same time. The supporting materials should fully explain the scientific nature, necessity, and compliance of the usage purpose, generally including ingredient usage purposes included in foreign cosmetic-related regulations and standards (original text and Chinese translation must be provided at the same time), or relevant function research materials, etc.

Question 5: How should restricted and permitted ingredients in the "Safety and Technical Standards for Cosmetics" be declared?

Answer: For restricted and permitted ingredients included in the "Safety and Technical Standards for Cosmetics," declarations shall comply with the requirements of the "Safety and Technical Standards for Cosmetics." For example, phenoxyethanol is included in the cosmetic permitted preservatives (Table 4) of the "Safety and Technical Standards for Cosmetics," and the usage purpose of this ingredient should be "preservative"; Butyl Methoxydibenzoylmethane is included in the cosmetic permitted sunscreens (Table 5) of the "Safety and Technical Standards for Cosmetics," and the usage purpose of this ingredient in ordinary cosmetics should be "light stabilizer."

Question 6: How many types of cosmetic ingredient usage purposes are there in the "Technical Guidelines for Cosmetic Ingredient Usage Purposes (Trial)"?

Answer: The appendix to the "Technical Guidelines for Cosmetic Ingredient Usage Purposes (Trial)" is the "Catalog of Cosmetic Ingredient Usage Purposes" (hereinafter referred to as the "Catalog"), including 72 types of ingredient usage purposes and descriptions. The "Catalog" was formulated based on full reference to relevant foreign standards and in accordance with China's current regulations, standards, and industry usage. The specific usage purposes are as follows:

Question 7: What matters are clarified in the NMPA Announcement on Matters Related to Toothpaste Filing Management (Announcement No. 124 of 2025)?

Answer: First, for toothpaste products with simplified filing, when the toothpaste filer organizes product filing materials, they can replace toxicological test reports with proof materials of the product's safe use history; Second, for simplified filing toothpaste products with the first product launch sales date after January 1, 2021, when the filer supplements filing materials, they can explain the product production and sales situation, whether quality safety incidents and adverse reaction monitoring have occurred, based on submitting a product safety assessment report that meets requirements, proving that the product has a safe use history, and are exempt from submitting oral mucosal irritation test reports.

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Further Information

Beijing Municipal Medical Products Administration