Caramel color safety - An update

Extensive safety testing has been conducted with the different classes of caramel color and its constituents, including toxicokinetics, genotoxicity, subchronic toxicity, carcinogenicity, and reproductive/developmental toxicity studies. In addition, data is available on uses and use levels that have been used to estimate intakes of caramel colors and their constituents. No Observable Adverse Effect Levels (NOAEL) have been identified for all classes and Acceptable Daily Intakes have been established to ensure safety of use. Available studies support a conclusion that caramel colors are not genotoxic or carcinogenic, and exposure estimates indicate that intake of caramel colors and constituents do not pose undue safety risks. This update summarizes available relevant safety studies and authoritative reviews on caramel colors and its toxicologically important constituents, 4-MeI and THI.