Exposure estimate for FD&C colour additives for the US population

Abstract

Dietary exposures to the seven food, drug, and cosmetic (FD&C) colour additives that are approved for general use in food in the United States were estimated for the US population (aged 2 years and older), children (aged 2–5 years) and teenage boys (aged 13–18 years) based on analytical levels of the FD&C colour additives in foods. Approximately 600 foods were chosen for analysis, based on a survey of product labels, for the levels of FD&C colour additives. Dietary exposure was estimated using both 2-day food consumption data from the combined 2007–10 National Health and Nutrition Examination Survey (NHANES) and 10–14-day food consumption data from the 2007–10 NPD Group, Inc. National Eating Trends – Nutrient Intake Database (NPD NET-NID). Dietary exposure was estimated at the mean and 90th percentile using three different exposure scenarios: low exposure, average exposure and high exposure, to account for the range in the amount of each FD&C colour additive for a given food. For all populations and all exposure scenarios, the highest cumulative eaters-only exposures in food were determined for FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition, the eaters-only exposure was estimated for individual food categories in order to determine which food categories contributed the most to the exposure for each FD&C colour additive. Breakfast Cereal, Juice Drinks, Soft Drinks, and Frozen Dairy Desserts/Sherbet (also referred to as Ice Cream, Frozen Yogurt, Sherbet (including Bars, Sticks, Sandwiches)) were the major contributing food categories to exposure for multiple FD&C colour additives for all three populations.

All You Can Feed: Some Comments on Production of Mouse Diets Used in Biomedical Research with Special Emphasis on Non-Alcoholic Fatty Liver Disease Research

“…However, in general this dye at 0-7 mg/kg of body weight per day is considered as safe [167]. In the US population, Allura Red AC belongs to the three highest cumulative eaters-only exposures of FD&C color additives in food products [176,177]. Although the European food safety authority expressed concerns about the usage of Allura Red AC as a food color additive, the dye has no genotoxic activity in different test systems [178].…”

Tiered intake assessment for food colours

“…The proportion of the ADI assigned to beverages was based on colour dietary intake assessments previously conducted by either the US FDA or EFSA. For the US assessment, the portion of the ADI assigned to beverages for each colour was based on the colour intake assessment conducted by Doell et al (2016). Doell et al (2016) presented the percent contributions of various food categories and beverages to the total intake of colours for the US population age 2 y and older, children 2-5 y, and teenaged boys 13-18 y in a series of charts.…”

“…For the US assessment, the portion of the ADI assigned to beverages for each colour was based on the colour intake assessment conducted by Doell et al (2016). Doell et al (2016) presented the percent contributions of various food categories and beverages to the total intake of colours for the US population age 2 y and older, children 2-5 y, and teenaged boys 13-18 y in a series of charts. The total percent contribution from beverages were determined for allura red, brilliant blue, sunset yellow and tartrazine and applied to each accordingly.…”

“…The total percent contribution from beverages were determined for allura red, brilliant blue, sunset yellow and tartrazine and applied to each accordingly. The average percent contributions from these four colours were then applied to all other colours of interest herein including those that were not evaluated by Doell et al (2016). The beverage percent contributions to total colour intake used to assign the portion of the ADI for beverages for children 2-5 y and 2 USD + y are summarised in Table 3. The UK assessments leveraged EFSA's opinions on Allura red (EFSA 2015a), amaranth (EFSA 2013), annatto norbixin-based (EFSA 2019a), azorubine (EFSA 2015b), brilliant black (EFSA 2015c), brilliant blue (EFSA 2010b), curcumin (EFSA 2014a), paprika (EFSA 2015d), quinoline yellow (EFSA 2015e), sunset yellow (EFSA 2014b) and tartrazine (EFSA 2009a) to determine the average percent contribution of nonmilk beverages to the total estimated intakes of these colours for the various subpopulations typically assessed by EFSA (data are summarised in Supplemental Appendix III).…”

Determination of Synthetic Dyes in Various Food Samples of Iran’s Market and their Risk Assessment of Daily Intake

“…5 and FD&C Yellow No. 6 [31]. In addition, the amount of daily exposures for children (2.43 ± 0.35 exposures) was higher than adults (0.76 ± 0.15 exposures) for US population [32].…”