SUPPLEMENTARY INFORMATION:

I. Background

FDA is requesting information on the current uses and safety data for azodicarbonamide (ADA) in human food and as a food contact substance as part of a post-market assessment. ADA (CAS No. 123-77-3) is used as a whitening agent in cereal flour and as a dough conditioner in breadmaking and has applications in manufacturing food contact materials.

All uses of ADA in food or as a food contact substance must be authorized for that use through a food additive regulation or an effective food contact notification, or be excluded from regulation as a food additive, for example, because such use is generally recognized as safe (GRAS) or is prior sanctioned (see Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). As described below, these uses of ADA in food and as a food contact substance in the U.S. are authorized by FDA's food additive regulations.

ADA is authorized as a direct food additive when used as an aging and bleaching ingredient in cereal flour and as a dough conditioner in bread baking in a total amount not to exceed 0.0045 percent (45 parts per million; 2.05 grams per 100 pounds of flour) (21 CFR 172.806). It is listed as an optional ingredient in the standards of identity for bread, rolls, and buns (21 CFR 136.110); flour (21 CFR 137.105); and whole wheat flour (21 CFR 137.200) when used in accordance with the regulations for ADA in 21 CFR 172.806. ADA is also permitted as an indirect food additive when used in closures with sealing gaskets for food containers (21 CFR 177.1210), rubber articles intended for repeated use (21 CFR 177.2600), and adjuvant substances used in the manufacture of foamed plastics (21 CFR 178.3010). We are not aware of any prior sanctions or conclusions that the use of ADA is GRAS in food or for food contact use.

As part of our systematic review of chemicals in food, FDA is beginning a post-market assessment of the safety of ADA as used in food and as a food contact substance. (see https://www.fda.gov/​food/​food-chemical-safety/​list-select-chemicals-food-supply-under-fda-review). This assessment supports the Make America Healthy Again Commission's recommendation to implement an evidence-based systematic process for post-market assessment of chemicals in food (see https://www.whitehouse.gov/​wp-content/​uploads/​2025/​09/​The-MAHA-Strategy-WH.pdf). The objective of our assessment is to determine if ADA is safe under its conditions of use in food or as a food contact substance considering the most recent science. While FDA previously concluded authorized uses to be safe, new information may require reconsideration of the regulatory status or the safe uses of a substance in or on food.

II. Request for Information

FDA is requesting information on uses, use levels, dietary exposure, and safety data on ADA currently used in food and as a food contact substance. This includes decomposition products of ADA, which are the chemicals formed when ADA breaks down, such as during breadmaking. Information from food manufacturers on uses and levels is crucial for food chemical assessments. We encourage food manufacturers to participate in this data call, with options for aggregated submissions through trade groups or other collaborations. We do not need information about individual products and their recipes, but rather data about the levels of use in general product categories. Voluntary submission of data and information on current uses and use levels will help to refine our dietary exposure assessments. We use maximizing assumptions to estimate dietary exposure (see, e.g., “Guidance for Industry: Estimating Dietary Intake of Substances in Food,” available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-estimating-dietary-intake-substances-food). Without refinements assisted by manufacturer use information, this may lead to overestimation of dietary exposure that could impact authorizations for the chemical's use in food or as a food contact substance.

Specifically, FDA requests the following:

1. General food categories in which ADA is used (for example, cookies, soft drinks, other categories listed in 21 CFR 170.3(n)), USDA's What We Eat in America survey (Ref. 1), or the Codex General Standard for Food Additives (Ref. 2));

2. Typical and maximum use levels of ADA in each applicable general food category;

3. Information on actual or expected residual levels of decomposition products of ADA (including semicarbazide and ethyl carbamate) in foods and food contact materials where ADA is used;

4. Information on the current food contact uses of ADA, including data on migration of ADA or its decomposition products from food contact materials into food;

5. Subpopulations with high dietary exposure to ADA or its decomposition products or particular safety concerns relevant to food and food contact uses of ADA;

6. Other dietary sources of ADA or its decomposition products, such as dietary supplements, natural occurrence in common foods, residues in animal products, or as contaminants in food or drinking water;

7. Market share of foods in each applicable general food category and food contact materials that are formulated with ADA;

8. Biomonitoring data for ADA, its decomposition products, or its metabolites;

9. Updated market disappearance or poundage data for ADA;

10. Information on potential chemically or pharmacologically related substances used in food or as a food contact substance;

11. Safety data relevant to use of ADA in food or as a food contact substance, including data pertaining to its decomposition products, and especially unpublished data;

12. Documentation of GRAS conclusions or prior sanctions for uses of ADA in food or as a food contact substance;

13. Information that may support the conclusion that ADA is no longer used for one or more of its authorized intended uses in food or as a food contact substance.

III. References

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

1. What We Eat in America Food Categories, available at https://www.ars.usda.gov/​ ( printed page 27062) northeast-area/​beltsville-md-bhnrc/​beltsville-human-nutrition-research-center/​food-surveys-research-group/​docs/​dmr-food-categories/​ .

2. Codex General Standard for Food Additives, available at https://www.fao.org/​gsfaonline/​foods/​index.html.