Technical Guidelines for In Vitro Mammalian Cell Gene Mutation Test (Draft for Comments)

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.

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, result analysis and evaluation, etc.