On May 12, 2026, the U.S. Food and Drug Administration finalized its new food chemical safety assessment program and simultaneously launched formal reassessments of two widely used food additives: butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).
As part of those reassessments, the agency issued Requests for Information (RFIs) calling on food manufacturers, researchers, and consumers to submit data on the use and safety of each substance. The public comment period closes July 13, 2026.
For food and ingredient companies operating in the U.S. market, the announcement marks a structural shift in how the FDA intends to oversee chemicals already in the food supply.
What the Finalized Framework Covers
Two documents now underpin the program. The first, “Enhanced Systematic Process for Post-Market Assessment of Chemicals in Food,” describes how the FDA will monitor and triage signals related to hazards, use, or exposure, then prioritize, evaluate, and manage chemicals in the food supply.
The second, the “Post-Market Assessment Prioritization Tool,” identifies which food chemicals warrant full scientific assessment, based on decisional criteria including toxicity, changes in exposure, presence in food for susceptible subpopulations, and new scientific information.
The scope is broader than traditional food additives alone. It covers colour additives, GRAS substances, food contact substances, and contaminants. The FDA will publish an annual assessment plan and maintain a public list of chemicals currently under review, giving industry ongoing visibility into what is in the pipeline.
BHT and ADA: The First Two Chemicals Under Review
BHT is used to prevent spoilage of fats and oils and appears in a wide range of products including breakfast cereals, frozen meals, baking mixes, cookies, chewing gum, and meat products. ADA functions as a whitening agent in cereal flour, a dough conditioner in breadmaking, and has applications in food contact materials.
The RFIs for both substances were published in the Federal Register on May 13, 2026 (91 Fed. Reg. 27054 for BHT; 91 Fed. Reg. 27060 for ADA). The FDA has explicitly encouraged food manufacturers and researchers to submit relevant data before the July 13 deadline. The data received will inform the agency’s assessment conclusions for each substance.
What This Means for Your Business
The new framework introduces predictability that post-market food chemical oversight in the U.S. has historically lacked, but it also raises a practical question: how prepared is your company if an ingredient you rely on enters the review pipeline?
Any food chemical is now a candidate for assessment, including GRAS ingredients, colour additives, and food contact substances. Companies with complex formulations should treat this as a reason to maintain current, documented safety substantiation for every ingredient in their portfolio, not only those currently flagged.
For manufacturers using BHT or ADA specifically, the July 13 comment deadline is the most immediate consideration. Submitting accurate usage and safety data is an opportunity to ensure the FDA has a complete picture of how these substances are used across the industry, and the quality of information submitted during this window will likely shape how each assessment proceeds.
Frequently Asked Questions
Does this program apply to GRAS ingredients, or only approved food additives?
The scope explicitly includes GRAS substances alongside approved food additives, colour additives, food contact substances, and contaminants. Ingredients operating under a self-affirmed or notified GRAS status are not exempt from review. Companies should ensure their safety substantiation reflects current scientific literature, particularly where new toxicological data has emerged since the original determination was made.
We use BHT in a product. Is there anything we need to do before July 13?
Submitting data to the RFI is not mandatory, but manufacturers with a direct stake in the BHT assessment have good reason to participate. The FDA has asked for information on current usage levels, exposure, and safety data. Companies uncertain about their documentation would benefit from reviewing it before the comment period closes. The RFI details are available in the Federal Register at 91 Fed. Reg. 27054.
How will the FDA determine which chemicals are assessed after BHT and ADA?
The Prioritization Tool evaluates chemicals based on toxicity data, changes in exposure or use patterns, presence in food consumed by vulnerable populations, and new scientific developments. The FDA has committed to publishing an annual assessment plan and maintaining a public tracking list, so industry will have advanced visibility into what is under active review.
Key Takeaways
- The FDA finalized its food chemical safety assessment program on May 12, 2026, releasing two framework documents to govern post-market reviews.
- BHT and ADA are the first chemicals formally assessed under the new program; RFIs are open until July 13, 2026.
- The framework covers food additives, colour additives, GRAS substances, food contact substances, and contaminants.
- The Prioritization Tool will determine which chemicals enter the pipeline, based on toxicity, exposure, and emerging science.
- Companies should audit ingredient safety documentation now and monitor the FDA’s List of Select Chemicals in the Food Supply Under FDA Review for additions.
- Details on the program and both RFIs are available through the FDA’s official announcement.
What Affected Companies Should Do Now
The FDA’s finalized food chemical safety assessment program formalizes a shift from reactive to proactive oversight of ingredients in the U.S. food supply. BHT and ADA are the starting point, but the framework is designed for ongoing and expanding use. Companies that have not revisited their ingredient safety documentation recently, or that rely on GRAS determinations made years ago, have reason to do so now.
Quality Smart Solutions works with food and ingredient companies to assess their regulatory exposure, review safety substantiation, and prepare for evolving FDA requirements. To discuss how this development may affect your products, contact Quality Smart Solutions or visit our FDA food compliance services page.
