Q&A on the Filing of Ordinary Cosmetics (Issue 65)

This Guidance outlines the requirements and guidelines for cosmetics registration and compatibility assessments with packaging materials.

The following are the points that are discussed in the document:

Compatibility Assessments:

Cosmetic registrants and record-keepers should evaluate the compatibility of cosmetics with packaging materials considering the ingredients, risk level, and other factors. They can use various methods such as extract study reports, historical safety data, compatibility study reports, and comprehensive evaluation of cosmetic safety reports. If there are issues, they should refer to the "Compatibility Technical Guidelines" for further research.

Similar Formula Systems:

When dealing with cosmetics with similar formula systems, registrants and recorders can use existing information and experimental data for compatibility assessments, provided they explain the reasons and circumstances.

Registration Application:

Registrants and recorders can submit applications after completing the accelerated test, with the long-term test report to be archived by the company.

Stability Evaluation Tests:

The time for influencing factor test, accelerated test, and long-term test should be determined based on the characteristics of the cosmetics and packaging materials. Multiple test time points should be set to study the quality changes of cosmetics.

Stability Evaluation Requirements:

For cosmetics with similar formula systems and the same packaging materials, stability assessments can be based on existing information and experimental data, but the reasons and circumstances must be stated.

Source: https://scjgj.gz.gov.cn/zwdt/tzgg/content/post_9769405.html##~https://scjgj.gz.gov.cn/zwdt/tzgg/

Region: China