Mutagenicity studies on migrants from food-contact silicone products based on Ames test and chemical analysis.

After simulating food migration using 95% ethanol at 70°C for 2 h on 63 food-contact silicone products, the Ames test was employed to evaluate the mutagenicity of their migrants. Chemical analyses of three positive samples were conducted using gas chromatography-mass spectrometry (GC-MS) and inductively coupled plasma mass spectrometry (ICP-MS). The results indicated that the TA98 strain was more sensitive than the TA97, TA100, and TA102 strains. None of the 30 nipples exhibited mutagenicity against the TA98 strain, whereas 26 of 33 kitchen utensils (79%) tested positive. Migration from a representative sample (K-19, mold) in 95% ethanol demonstrated mutagenicity whether used at room temperature, baked, or frozen, indicating higher mutagenicity when in contact with fatty foods. A total of 22 organic compounds and 14 metal elements were detected in the samples, with migration levels of heavy metals and phthalates below the specific migration limits. The significant difference in results between nipples and kitchenware may be related to differences in their formulations and processing techniques. Further studies are needed to identify the key substances responsible for mutagenicity in these samples and to conduct subsequent risk assessments. Although potentially harmful, these findings do not necessarily indicate a safety risk.