Synthetic organic dyes used as color additives in food have recently come under increased scrutiny both in the U.S. and internationally. It has been suggested that consumption of these color additives can cause changes in behavior, especially in children. In the U.S., the dyes that have been of primary concern are FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red. No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6. All of these color additives are certified by the Food and Drug Administration (FDA) and permitted for use in foods generally at levels consistent with good manufacturing practice.In response to concerns raised about these color additives, the FDA convened its Food Advisory Committee (FAC) in 2011 to consider data on the possible association between children's consumption of these color additives in food and hyperactivity or other behavioral effects. The FAC concluded that a causal link between children's consumption of synthetic color additives and behavioral effects had not been established based on the available data. However, they recommended further research, including a comprehensive exposure assessment for these color additives, especially for children. Based on this recommendation, FDA conducted a robust exposure assessment of the FD&C colors. Foods that contain FD&C colors were identified, grouped into broad food categories, and then matched with food codes from the combined 2007-2010 National Health and Nutrition Examination Survey (NHANES). The levels of FD&C colors in hundreds of foods were determined using high performance liquid chromatography (HPLC). Dietary exposures from the use of each FD&C color in food were estimated for various age groups, including the U.S. population aged 2 years or more and several subpopulations with a focus on children. This study summarizes the results of this exposure assessment.

Exposure estimate for FD&C colors for the U.S. population

248th National Meeting (2014)

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