a comprehensive review of azodicarbonamide

1. What is azodicarbonamide (ADA)?

Azodicarbonamide (ADA) is a chemical substance approved for use as a whitening agent in cereal flours and as a dough conditioner in bread baking.

2. On what basis did the FDA approve the use of the ADA?

FDA approved ADA as a food additive and dough improver in grain flours based on a comprehensive review of safety studies, including multi-year feeding studies azodicarbonamide

3. What is FDA doing to continue to ensure the safe use of ADA in food?

FDA continues to evaluate the safe use of ADA in food. In 2016, the agency conducted a comprehensive exposure assessment of semicarbazide (SEM), a breakdown chemical formed from ADA during breadmaking. This assessment is based on (1) SEM quantities derived from the analysis of more than 250 representative breads and bread products using the ADA, and (2) data from two different sets of food consumption data: a) combined data from 2009-2012 National Health and Nutrition Examination Survey (NHANES) 2-day dietary intake survey; b) 2007-2010 NPD Group, Inc. National Eating Trends-Nutrient Intake Database (NPD NET-NID) 10-14 days of data, using proprietary food Analysis and Residue Evaluation - National Eating Trends (FARE-NET) Program.

Based on this information, FDA developed SEM exposure estimates for the U.S. population 2 years of age or older and children 2-5 years of age. Children aged 2-5 years were selected because they were expected to have the greatest exposure to SEM by weight. This exposure assessment was presented at the 251st National Meeting of the American Chemical Society on March 15, 2016. See Poster on Estimation of Exposure to Semicarbazides Using Azodicarbonamide in the U.S. Population Poster (PDF: 664KB).

4. What about the studies showing that ADA breakdown products (particularly semicarbazides) are carcinogens?

During the breadmaking process, ADA breaks down completely to form other chemicals, one of which is SEM. At high levels, SEM has been shown to increase tumor incidence when fed to female mice, but not male mice or rats of either sex. These studies were conducted in rodents with SEM levels well in excess of estimates of human exposure from consumption of ADA-treated flour or bread products.

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