Abstract:

Six kinds of cosmetics, including cleanser, care cosmetics and makeup categories, and seven representative microorganisms were selected to conduct the partial equivalence study between amplified ATP bioluminescence assay and the detection method of aerobic bacterial count and molds and yeast count in Safety and Technical Standard for Cosmetics （2015th Edition）. The seven representative microorganisms were inoculated into the six kinds of cosmetics at target concentrations of 10, 5, 1 and 0.1 CFU/g, respectively. Tests on each concentration were repeated five times. Fisher exact test statistical analysis show that the detection limit of amplified ATP bioluminescence assay is significantly better than that of the standard method （p=0.000 1）. Seven representative strains grew well in the MTAT medium, and the results of artificially contaminated samples detected by the amplified ATP bioluminescence assay were all positive, indicating that the method has good specificity. Three different laboratories were selected to compare the two methods using the same samples, and no statistical difference was found in the results, indicating the method is reproducible （p>0.05）. The enrichment media MTAT, prepared with selected brands of TAT base medium, were assessed using growth promotion, and their ATP test results were all positive, indicating that the method is has good durability. Therefore, the amplified ATP bioluminescence assay is partially equivalent to the standard method.

Key words: amplified ATP bioluminescence assay, cosmetics, microbial detection, method validation