Caramel color

What this is

Regulatory treatment is mixed but does not amount to a broad all-food ban. In the U.S., FDA permanently lists caramel as a color additive exempt from certification and allows it in foods generally under good manufacturing practice, with specifications and standard-of-identity caveats. FDA also says Class III and Class IV caramel labeling need not identify the class; those classes can contain 4-MEI, while Class I and II do not. FDA has a risk-management review for 4-MEI in Class III/IV caramel and is evaluating whether limits are needed. EFSA concluded in 2011 that caramel colours are neither genotoxic nor carcinogenic and set a group ADI, with a lower E150c limit due to THI uncertainty; its 2012 refined exposure found combined exposure below the group ADI but possible exceedance for high E150c consumers. California lists 4-MEI under Prop 65 with a 29 µg/day NSRL, and Texas has enacted a school-meal restriction for INS 150c/150d. The main concern is process by-products in ammonia-based classes, not all caramel color.

Safety Review

The critical endpoints experts review in safety assessments. This is not a prediction of harm.

The toxicology concern does not apply equally to every caramel color class. FDA notes that Class III and Class IV caramel colors can contain 4-MEI, while Class I and II do not; FDA is reviewing 4-MEI levels and manufacturing controls. EFSA concluded caramel colors are not genotoxic or carcinogenic as a group and found combined exposure below the group ADI, but identified possible high-consumer exceedance for E150c and set a lower E150c-specific limit because of THI immune-effect uncertainty.