The U.S. Food and Drug Administration (FDA) has amended the food additive regulation for the safe use of hydrogen peroxide in food production as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. The final order, published in the Federal Register, has been made in response to a food additive petition filed by Cargill.

Specifically, FDA amended the reference for specifications for hydrogen peroxide established in the Code of Federal Regulations 21 § 173.356(a) by adopting, and incorporating by reference, the monograph for hydrogen peroxide in the Food Chemicals Codex, Edition 14.

Hydrogen peroxide is affirmed as generally recognized as safe (GRAS) for use as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide in specific foods at specified maximum treatment levels. As a condition of use, residual hydrogen peroxide be removed during the processing of food by appropriate physical and chemical means. In addition, a substance affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use, and that any additional uses require a food additive regulation. Therefore, any additional uses of hydrogen peroxide in processing food beyond those limitations require a food additive regulation.

Therefore, the food additive regulations were previously amended to approve the use of hydrogen peroxide as an antimicrobial agent in the production of modified whey by ultrafiltration methods. As a condition of use, residual hydrogen peroxide must be removed from the whey during processing by appropriate chemical or physical means.

Cargill’s petition proposed to further amend regulations to provide for the use of hydrogen peroxide in food, including meat and poultry, as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide, in accordance with good manufacturing practices (GMPs), provided that residual hydrogen peroxide is removed from the food during processing by appropriate chemical or physical means. FDA notes that the current use as an antimicrobial agent in the production of modified whey is encompassed by the broader uses proposed in the petition.

FDA reviewed data in the petition and other relevant material to evaluate the safety of the petitioned uses. Cargill discussed that hydrogen peroxide is inherently unstable and will dissociate into water and oxygen and that any measurable amounts of hydrogen peroxide would be required to be removed from food during processing by appropriate chemical or physical means. Given the unstable nature of hydrogen peroxide and the requirement that residual hydrogen peroxide be removed, FDA concurred that the petitioned uses will not result in an increased dietary exposure to hydrogen peroxide.

Although the final order is effective as of September 3, 2025, stakeholders may submit objections via www.regulations.gov under Docket No. FDA-2022-F-2725 for “Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide.”