H.R. 4306 — Food Chemical Reassessment Act of 2025

This section establishes in the Food and Drug Administration an Office of Food Chemical Safety, Dietary Supplements, and Innovation to systematically and continuously reassess, not less frequently than once every three years beginning in 2026, the safety of at least 10 food additives approved under subsection (c), color additives, generally recognized as safe (GRAS) substances, prior-sanctioned substances, or food contact substances (or classes thereof), prioritized by public health need. (As background: These substances are used in food production; food additives, color additives listed in 21 USC 721, and food contact substances require premarket FDA regulation or notification to avoid deeming food adulterated, while GRAS and prior-sanctioned substances are exempt from premarket review.) It requires public notice of each reassessment's determinations and directs the Secretary, if a substance is found unsafe, to (1) amend or repeal the relevant food additive regulation; (2) amend or repeal the relevant color additive regulation; (3) publicly declare the GRAS substance unsafe or safe with conditions; (4) revoke prior-sanctioned status; or (5) deem a food contact substance notification no longer effective. (Thus, unsafe determinations could restrict or prohibit use of affected substances in food.) It identifies as the first 10 substances (or classes) potentially subject to reassessment: (1) tert-butylhydroquinone; (2) titanium dioxide; (3) Red Dye 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3; (4) perchlorate; (5) butylated hydroxyanisole (BHA); (6) butylated hydroxytoluene (BHT); (7) trichloroethylene, methylene chloride, benzene, and ethylene chloride; (8) propyl gallate; (9) sodium benzoate; and (10) sodium nitrite. It further requires the Secretary to re-establish the Food Advisory Committee within 180 days of enactment to advise on reassessment standards, processes, and methods and clarifies that the provision does not alter the Secretary's existing authorities.