On April 27, 2023, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on seven technical guidelines for the testing of cosmetic products and new cosmetic ingredients. This guideline is one of the seven technical guidelines.
When applying for anti-hair loss or hair dyeing products registration, it is required to submit bacterial reverse mutation test data. In addition, this test is used to assess the mutagenicity of NCIs, and is commonly adopted as evidence for assessing the mutagenicity of cosmetic ingredients in safety assessments.
During the review of test reports or data, it was frequently found that there were errors in the setting of the highest concentration of the test substance, or the result judgement was unreasonable. This guideline is therefore established to standardize the practical application of the bacterial reverse mutation test. Consisting of 5 parts, it introduces basic test principles and operation requirements, and gives guidance on result analysis and evaluation.