Concerns have been raised regarding the health effects of 4-methylimidazole (4-MEI), a contaminant found in caramel colors produced using ammonium compounds (Class III and IV Caramels). These concerns stem from: 1) results of toxicological testing conducted by the National Toxicology Program (NTP) on 4-MEI in rats and mice, and 2) the levels of 4-MEI that have been found primarily in beverages containing caramel color.  To better understand the dietary exposure to 4-MEI, the Food and Drug Administration (FDA) conducted a robust exposure assessment of 4-MEI from the use of Class III and IV Caramels in foods.  Foods that contain caramel color were identified from label surveys, grouped into broad food categories, and then matched with food codes from the combined 2007-2010 National Health and Nutrition Examination Survey (NHANES). Based on information from the label survey, more than 200 representative foods containing caramel color were selected for 4-MEI analysis using liquid chromatography-tandem mass spectrometry (LC-MS/MS).  Dietary exposure for 4-MEI was estimated for six U.S. population groups: 1) the U.S. population aged 2 years or more; 2) infants (< 1 year old); 3) children aged 1 year; 4) children aged 2-5 years; 5) children aged 6-12 years; and 6) teenage boys aged 12-18 years.

Refined exposure assessment for 4-methylimidazole (4-MEI) for the U.S. population based on quantitative data from foods containing caramel color

248th National Meeting (2014)

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