Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 173</CFR> <DEPDOC>[Docket No. FDA-2022-F-2725]</DEPDOC> <SUBJECT>Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective September 3, 2025. The incorporation by reference of certain material listed in the order is approved by the Director of the Federal Register as of September 3, 2025. Either electronic or written objections and requests for a hearing on the order must be submitted by 11:59 p.m. Eastern Time on October 3, 2025. See section VIII of this document for further information on the filing of objections. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept objections until 11:59 p.m. Eastern Time at the end of October 3, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic objections in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2022-F-2725 for “Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide.” Received objections, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Karen Hall, Office of Food Chemical Safety, Dietary Supplements, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-9195; or Keronica C. Richardson, Office of Policy, Regulations, and Information. Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> In the <E T="04">Federal Register</E> of November 21, 2022 (87 FR 70752), FDA announced that we filed a food additive petition (FAP 2A4833) submitted by ToxStrategies on behalf of Cargill, Inc., 15407 McGinty Rd., Wayzata, MN 55391. The petition proposed that FDA amend the food additive regulations in 21 CFR 173.356 to provide for the safe use of hydrogen peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. FDA is also updating the reference for specifications for hydrogen peroxide established in § 173.356(a) by incorporating by reference the monograph for hydrogen peroxide in the 14th edition of the Food Chemicals Codex, effective June 1, 2024 (FCC 14 hydrogen peroxide monograph). The current food additive regulation for the use of hydrogen peroxide (§ 173.356) indicates that the additive must meet the specifications in the 7th edition of the FCC (FCC 7), and Cargill indicated in the petition that hydrogen peroxide will meet the specifications in the 12th edition of the FCC (FCC 12). Since we received the petition, the FCC has been updated to the 14th edition (FCC 14). The specifications for hydrogen peroxide in FCC 7 and FCC 12 are identical to those in FCC 14. Therefore, we are amending § 173.356(a) by adopting, and incorporating by reference, the FCC 14 hydrogen peroxide monograph. Hydrogen peroxide is affirmed as generally recognized as safe (GRAS) under 21 CFR 184.1366 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 (46 FR 44439, September 4, 1981, and 51 FR 27172, July 30, 1986). As a condition of use, § 184.1366(d) requires that residual hydrogen peroxide be removed during the processing of food by appropriate physical and chemical means. In addition, § 184.1366(c) incorporates the requirement under § 184.1(b)(2) that 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 set out in § 184.1366 require a food additive regulation. The food additive regulations were subsequently amended to add § 173.356 (76 FR 11328, March 20, 2011) 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, § 173.356(b) requires that residual hydrogen peroxide be removed from the whey during processing by appropriate chemical or physical means. The petition proposed to amend § 173.356 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 practice, provided that residual hydrogen peroxide is removed from the food during processing by appropriate chemical or physical means. We note that the current use as an antimicrobial agent in the production of modified whey listed in § 173.356 is encompassed by the broader uses proposed in this petition. <HD SOURCE="HD1">II. Evaluation of Safety</HD> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 21k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━