In the complex process of cosmetic safety assessment, there may be instances where traditional ingredient-based safety evaluations are insufficient. This section outlines the procedures for conducting safety testing on final cosmetic products when ingredient-level assessments are not feasible or complete, with specific reference to key regulatory guidelines.

When to Conduct Safety Testing of Final Cosmetics

Safety testing of final cosmetic products may be necessary under the following circumstances:

1. After thorough research, it’s not possible to use any data types specified in the “Guidelines for Use of Cosmetic Ingredient Data” (《化妆品原料数据使用指南》) for a safety assessment.
2. The safety assessment cannot be completed solely due to the lack of some toxicological endpoint assessment data.
3. The product contains low concentration non-special functional ingredients that meet specific criteria (detailed below).

Criteria for Eligible Ingredients

For ingredients to be eligible for this approach, they must meet the following conditions:

1. Be non-special functional ingredients
2. Be present in low concentrations
3. The number of such ingredients must not exceed 10% of the total number of formula ingredients

Procedure for Safety Testing

When the above conditions are met, product safety testing can be conducted by referring to:

1. Toxicological test items and/or
2. Human body test items

These items should be set up in accordance with the “Working Rules for Cosmetic Registration and Notification Testing” (《化妆品注册和备案检验工作规程》).

Ethical Considerations

It is crucial to note that all human body tests must meet ethical requirements as stipulated in the “Working Rules for Cosmetic Registration and Notification Testing”. This ensures the safety and rights of human participants in the testing process.

Comprehensive Safety Evaluation

The results of these tests should be used to fulfill a comprehensive safety evaluation and analysis of the final products. This evaluation should consider:

1. The results of the toxicological tests
2. The outcomes of any human body tests
3. The overall formulation of the product
4. The intended use and application of the product

Conclusion

While ingredient-based safety assessments, as outlined in the “Guidelines for Use of Cosmetic Ingredient Data”, are the primary method for ensuring cosmetic safety, this approach provides a valuable alternative when such assessments are not feasible. By allowing for the testing of final products under specific circumstances and in accordance with the “Working Rules for Cosmetic Registration and Notification Testing”, regulators ensure that all cosmetics on the market meet rigorous safety standards, even when traditional assessment methods are insufficient.

This approach demonstrates the flexibility and thoroughness of China’s cosmetic safety regulations, ensuring consumer safety while allowing for innovation in the cosmetics industry.