- What is azodicarbonamide (ADA)?
- On what basis did FDA approve the use of ADA?
- What has FDA done to continue to ensure the safe use of ADA in foods?
- What about studies that show breakdown products of ADA, specifically semicarbazide, to be a carcinogen?
- Does FDA recommend consumers change their diets?
- How do I know whether bread products contain ADA?
- Is ADA necessary to make bread?
- Does ADA have other uses?
Azodicarbonamide (ADA) is a chemical substance approved for use as a whitening agent in cereal flour and as a dough conditioner in bread baking.
FDA approved the use of ADA as a food additive in cereal flour and as a dough conditioner based on a comprehensive review of safety studies, including multi-year feeding studies.
FDA has continued to evaluate the safe use of ADA in foods. In 2016, the agency conducted a comprehensive exposure assessment of semicarbazide (SEM) – a breakdown chemical that forms from ADA during bread making. This assessment was based on (1) the amount of SEM from the use of ADA from the analysis of over 250 representative bread and bread products, and (2) data from two different sets of food consumption data: a) the combined 2009-2012 National Health and Nutrition Examination Survey (NHANES) 2-day dietary intake survey; and b) the 2007-2010 NPD Group, Inc. National Eating Trends-Nutrient Intake Database (NPD NET-NID) 10-14 day data using the proprietary Foods Analysis and Residue Evaluation-National Eating Trends (FARE-NET) program.
Based on this information, FDA developed exposure estimates for SEM for the U.S. population aged 2 years or more and children aged 2-5 years. Children aged 2-5 years were chosen because they would be expected to have the highest exposure to SEM per body weight. This exposure assessment was presented at the 251st National Meeting of the American Chemical Society, on March 15, 2016. See the Exposure Estimate for Semicarbazide from the Use of Azodicarbonamide in Bread for the U.S. Population poster (PDF: 664KB).
4. What about studies that show breakdown products of ADA, specifically semicarbazide, to be a carcinogen?
During bread making, ADA completely breaks down to form other chemicals, one of which is SEM. At high levels, SEM has been shown to increase the incident of tumors when fed to female mice, but not to male mice or either gender of rat. These studies were conducted in rodents at levels of SEM that far exceed estimates of human exposure from the consumption of ADA-treated flour or bread products.
Based on the science, FDA is not recommending that consumers change their diets because of exposure to ADA/SEM. FDA considers ADA a safe food additive when used for the purposes and at the levels specified in the FDA regulations.
ADA, like all ingredients intentionally added to food, must be listed on the ingredient label. Consumers are able to identify the addition of ADA by looking for “azodicarbonamide” on the label.
No. The use of ADA as a whitening agent and dough conditioner is not necessary to make bread and there are alternative ingredients approved for use available.
Yes, ADA is also authorized for use as a blowing agent in sealing caps for food containers such as ketchup bottles. In 2005, the European Food Safety Authority (EFSA) assessed the risk from the use of ADA as a blowing agent and concluded that it is not of concern for human health given the levels that have been found in foods packaged in glass jars and bottles. However, EFSA had also noted that exposure to SEM should be limited where possible, and the European Union banned this use of ADA.