The U.S. Food and Drug Administration (FDA) has set up a new monitoring system for additives already in use in the food sector. In particular, on May 12, 2026, FDA announced two significant initiatives for food safety:

1. Finalization of the new post-market assessment program for food chemicals.
2. Launch of the scientific reassessment of the additives BHT (butylated hydroxytoluene) and ADA (azodicarbonamide).

As part of this review, the FDA issued two Requests for Information (RFIs) and data concerning the use and safety of these substances in the food sector, opening a public consultation period for food companies, researchers, and consumers, which will close on July 13, 2026.

The post-market monitoring program

The FDA has finalized two technical documents intended to guide the annual reassessment plan for food chemicals:

• Enhanced Systematic Process:  defines the way in which the agency monitors and evaluates the safety of food chemicals after they have been placed on the market, and no longer only during the pre-market authorization phase. This process includes the collection and assessment of risk signals, the prioritization of substances posing the greatest health concerns, and potential decisions on restrictions or changes in use.

• Post-Market Assesment Prioritization Tool : allows the FDA to determine which food chemicals should undergo assessment first based on public health risk criteria (toxicity, level of exposure, availability of new scientific evidence).

Overall, these measures aim to strengthen public health protection and update safety assessments based on emerging evidence.

BHT and ADA: the substances under review

The first application of the new protocols focuses on two substances widely used on the U.S. market.

• BHT (Butylated Hydroxytoluene): used in the U.S. as an additive to prevent the oxidation of fats and oils in breakfast cereals, pizzas and frozen meals, baking mixes, cookies, chewing gum, and meat products, with limitations depending on the product category.

It is worth noting that the use of BHT in the European Union is already restricted: it is authorized with use limitations in specific categories and subject to concentration limits. In particular, BHT is authorized in food supplements in limited amounts of up to 400 mg/kg, resulting from the cumulative sum with other additives or as an individual value; it is not permitted in foods for infants or in flavored beverages.

• ADA (Azodicarbonamide): used on the U.S. market as a bleaching agent for flour and as a dough improver in baking. In the European Union, ADA is not authorized in any form within the food supply chain.

The public consultation will close on July 13, 2026: anyone interested in defending the ingredient and who has up-to-date evidence supporting its safety is invited to participate.

RFI: implications and responsibilities for companies in the food sector

The reassessment of a food chemical is formalized through the launch of the related Request for Information (RFI).

The consultation does not constitute an obligation, but rather an opportunity for food companies to provide updated data on the safety of the ingredients, where available. In the event of insufficient data, information, or evidence supporting the safe use of the substance under review, the FDA will adopt a precautionary approach aimed at protecting public health.

SOURCES:
https://www.fda.gov/news-events/press-announcements/fda-finalizes-food-chemical-safety-post-market-assessment-program-launches-reassessment-bht-ada

https://eur-lex.europa.eu/legal-content/IT/TXT/PDF/?uri=CELEX:02008R1333-20260218