On February 23, 2023, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on six technical guidelines for in vitro testing, determination for sun protection factor (SPF) and waterproof performance, as well as acute inhalation toxicity testing. This Guidelines is one of the six technical guidelines.
During the review of the test report or data, it was frequently found that there were errors in the setting of the highest concentration of the test substance or the number of metaphases used for chromosome analysis, or the result judgement was unreasonable.
This Guidelines is to standardize the application of this test in assessing the mutagenicity of cosmetic products and NCIs.
The main contents of the Guidelines include the formulation background, legal basis, application scope, basic principles, principles of test substance preparation and dosage design, control substance setting principles, selection principles of cells and exogenous metabolic activation systems, experimental design, result analysis and evaluation, etc.