Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 59)

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. What does it mean to archive and inspect cosmetic safety assessment reports?

The archiving and inspection of cosmetic safety assessment reports is an innovative measure to implement corporate responsibility and reduce the workload of document submission during the cosmetics registration and filing process. It does not mean the exemption from preparing cosmetic safety assessment reports, nor does it reduce the requirements for product safety assessments. Enterprises are required to complete the safety assessment of a product and produce a safety assessment report before applying for registration or filing. They can refer to the "Self-Inspection Key Points for Cosmetic Safety Assessment Reports" to conduct a self-inspection of the safety assessment report. According to the "Guidelines for Submission of Cosmetic Safety Assessment Data," only the basic conclusions of the safety assessment need to be submitted, while the safety assessment report should be kept on file within the enterprise for inspection. If the regulatory authorities discover any issues during inspections, they will address them in accordance with the law.

2. How should the test items for the safety testing of final cosmetic products be selected? What are the requirements for laboratories and test reports?

For the safety testing of final cosmetic products, one can refer to the "Guidelines for the Inspection of Cosmetics Registration and Filing" to select toxicological test items and/or human test items (provided they meet ethical standards) for different categories of products, in order to conduct a comprehensive evaluation and analysis of the product's safety. The requirements for laboratories and test reports must comply with the provisions of the "Guidelines for the Inspection of Cosmetics Registration and Filing."

3. How should one correctly understand and use the "Information on Ingredients Used in Marketed Products"?

The "Information on Ingredients Used in Marketed Products" (hereinafter referred to as "Ingredient Information") is an objective record of the usage of ingredients in special cosmetics within the validity period of their approval in China, which have been used but not included in the "Cosmetic Safety Technical Specifications" and for which there are no assessment reports from international authoritative cosmetic safety assessment organizations. This information is dynamically updated. As there has been no systematic evaluation organized for the listed ingredients, cosmetic registrants and filers using this ingredient information must comply with relevant national laws, regulations, standards, and specifications, and carry out cosmetic safety assessments. When producing products, if the amount of an ingredient exceeds the usage listed in the "Ingredient Information," the cosmetic registrant or filer should conduct a safety assessment in accordance with the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)," or use other types of ingredient data in accordance with the "Guide on the Use of Cosmetic Ingredient Data."

4. What are the principles for the reference use of the "Information on Ingredients Used in Marketed Products"?

Principle One for reference use: For the same ingredient acting on the same site, if only the usage amount for leave-on products is available, rinse-off products can refer to the usage of leave-on products. Principle Two for reference use: For the same ingredient used in the same manner, the usage can be referenced in the following order: (1) whole body skin, trunk parts, face, lips, eyes; (2) whole body skin, trunk parts, hands and feet, head, hair. Later application sites can refer to the ingredient usage amounts of earlier sites. However, if the product is intended for the eye area and references usage amounts from other areas, additional assessment of the ingredient's potential for eye irritation is required.

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