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Additives/Preservatives

The FDA Just Reopened the File on a Bread Additive It Called Safe

Published July 19, 2026

Azodicarbonamide has been legal in U.S. bread and flour since the 1960s, capped at 45 parts per million under federal rule. On May 13, 2026, the FDA published a formal request for public data on how it breaks down in food, how far it migrates, and who eats the most of it — the opening move in a safety re-review of a chemical the agency has defended for decades.

What just happened

On May 12, 2026, FDA finalized a new standing process for reassessing food chemicals already on the market, built around two internal documents: the "Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food" and a companion "Post-Market Assessment Prioritization Tool." FDA Commissioner Marty Makary framed it as a response to public demand, saying "Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply." The very next day, the agency used that new process for the first time on azodicarbonamide (ADA), publishing "Azodicarbonamide (ADA); Request for Information" in the Federal Register (91 Fed. Reg. 27060, Docket FDA-2026-N-4126).

The request itself is narrow and specific. FDA asked manufacturers, researchers, and the public for data on ADA's current use levels in food; on the residual levels of its breakdown products — semicarbazide and ethyl carbamate — left in finished food and in food-contact materials; on how much of those breakdown products migrate into food; on which groups of people eat the most of it; and on any biomonitoring data tracking ADA or its metabolites in humans. The comment period ran from May 13 to July 13, 2026, and closed on schedule. FDA reopened the comment window on the companion chemical in this same round, BHT, for another 30 days through August 31, 2026, but not for ADA — the agency's stated reason is procedural: it says it simply "did not receive requests from interested parties for additional time." No follow-up action has posted to the docket as of this writing. A request for information is not a proposed rule and not a finding of harm — it's FDA collecting the record before it decides whether one is warranted.

How we got here

FDA's current position rests on a much older record. The agency's own ADA FAQ describes basing its original approval on "a comprehensive review of safety studies, including multi-year feeding studies," and the current rule, 21 CFR 172.806, authorizes ADA as a bleaching and aging agent in cereal flour and as a dough conditioner in bread baking, at a combined limit of 45 ppm across both uses.

The complication is what ADA becomes once it's baked. In moist flour, azodicarbonamide reacts to form biurea as its main byproduct, with semicarbazide and ethyl carbamate forming as secondary reaction products that persist through baking. FDA's FAQ acknowledges that semicarbazide showed increased tumors in female mice in animal studies, but the agency's position — based on a 2016 exposure assessment — is that those animal doses "far exceed estimates of human exposure," and it does not recommend consumers change their diets. The same FAQ page also states plainly that "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" — a fact FDA volunteers even while standing by the additive's safety.

The additive became a public flashpoint in 2014, when consumer pressure over its dual use as a rubber and plastics blowing agent led Subway and Wendy's to announce they'd drop it from their bread. That controversy didn't change the federal rule; ADA has remained authorized at 45 ppm the entire time. What changed in 2026 is that FDA itself opened a formal channel for new evidence to be weighed against that standing approval.

Where regulators diverge

The U.S. and EU frameworks reach different results, but for a more specific reason than "banned abroad." In its own written comments to the Codex Committee on Food Additives, the European Union has stated flatly that "azodicarbonamide is not authorised as a food additive in the EU" — meaning ADA never cleared the EU's positive-list approval process for food use in the first place, a different track from the U.S. system where FDA reviews and authorizes a substance directly.

The EU does have a separate, older, and more specific action on ADA: in 2004, the European Commission suspended azodicarbonamide's use as a blowing agent in plastic food-contact materials (think gasket seals on jar lids), under Commission Directive 2004/1/EC. The recitals cite the EU's Scientific Committee on Food, which found on October 1, 2003, that semicarbazide showed "weak carcinogenic activity in laboratory animals and weak genotoxicity in vitro" but could not determine whether it posed an actual cancer risk to humans. Regulators had detected semicarbazide in a number of foods packaged in glass jars, at levels up to 25 micrograms per kilogram, concentrated in baby food. The Commission invoked the precautionary principle and phased out the plastics use by August 2, 2005 — not a bread-additive rule, but the underlying safety question is the same one FDA is now asking about the food use directly.

What the label actually says

If a product contains ADA, U.S. labeling rules require it to appear on the ingredient list by name — "azodicarbonamide." There's no alternate or hidden name to watch for. It shows up almost exclusively in commercial bread, buns, and other baked goods as a dough conditioner, and less commonly as a bleaching agent in flour sold for baking. Many major chains have already reformulated away from it since 2014, but it remains legal, and some products on U.S. shelves still carry it. Reading the ingredient panel is the only reliable way to know.

Where PurityIQ fits in

This is exactly the kind of moving regulatory record PurityIQ is built to surface at the point of decision. The app doesn't score azodicarbonamide or tell you what to think about a comment period that's still working its way through FDA — it shows you whether a scanned product contains it, what the current federal limit is, and what the agency has said about it, cited to the primary record. You see what's actually happening in Washington and Brussels; you decide what it means for your cart.

Primary Sources

FDA Federal Register notice, "Azodicarbonamide (ADA); Request for Information" — https://www.federalregister.gov/documents/2026/05/13/2026-09508/azodicarbonamide-ada-request-for-information

FDA press release, "FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA" — https://www.fda.gov/news-events/press-announcements/fda-finalizes-food-chemical-safety-post-market-assessment-program-launches-reassessment-bht-ada

FDA, "Azodicarbonamide (ADA) Frequently Asked Questions" — https://www.fda.gov/food/food-additives-petitions/azodicarbonamide-ada-frequently-asked-questions

eCFR, 21 CFR 172.806 (Azodicarbonamide) — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172/subpart-I/section-172.806

European Commission comments to Codex Committee on Food Additives (CCFA51) on azodicarbonamide authorization status — https://food.ec.europa.eu/document/download/9bead861-d9da-4894-93b6-1f0191679177_en?filename=codex_ccfa_51_agenda_item-4b.pdf

Commission Directive 2004/1/EC of 6 January 2004 (OJ L 7/45, published 13 January 2004), suspending azodicarbonamide as a blowing agent in food-contact plastics — https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:007:0045:0046:EN:PDF

IARC Monographs, List of Classifications (semicarbazide hydrochloride, Group 3) — https://monographs.iarc.who.int/wp-content/uploads/2018/09/ClassificationsAlphaOrder.pdf

As of August 21, 2026.

Sources

PurityIQ puts this same public record in front of you at the shelf. Cited to source. No score. Join the early-access list.