Frequently Asked Questions about Azodicarbonamide

1. What is azodicarbonamide (ADA)?

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

2. On what basis does the FDA approve the use of the Azodicarbonamide?

The FDA approved the use of ADA as a food additive and dough improver in cereal flours based on a comprehensive review of safety studies, including multi-year feeding studies.

3. What steps is FDA taking 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) the amount of SEM generated using ADA in an analysis of more than 250 representative breads and bakery products, and (2) data from two different sets of food consumption data: a) combined 2009-2012 National Health and Nutrition Examination Survey (NHANES) 2-day Dietary Intake Survey; b) 2007-2010 NPD Group, Inc. National Dietary Trends-Nutrient Intake Database (NPD NET-NID) 10-14 days of data, using proprietary food Analysis and Residue Evaluation - Dietary Trends Nationally (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 ages 2-5 were chosen because they have the highest 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 Estimates of Exposure to Semicarbazides Using Azodicarbonamide in Bread in the U.S. Population Poster (PDF: 664KB).

4. So what if studies have shown that breakdown products of ADA (especially semicarbazides) are carcinogens?

During the breadmaking process, ADA is completely broken down to form other chemicals, one of which is SEM. At high levels, SEM was shown to increase the incidence of tumors when fed to female mice, but not male mice or rats of either sex. These studies were performed in rodents at levels of SEM that far exceeded estimates of human exposure from consumption of ADA-treated flour or bread products.

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