Rule2025-16898
Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2025
Effective
September 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 90 Issue 168 (Wednesday, September 3, 2025)</title>
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[Federal Register Volume 90, Number 168 (Wednesday, September 3, 2025)]
[Rules and Regulations]
[Pages 42535-42538]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16898]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. FDA-2022-F-2725]
Secondary Direct Food Additives Permitted in Food for Human
Consumption; Hydrogen Peroxide
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
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SUMMARY: 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).
DATES: 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.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
Electronic Submissions
Submit electronic objections in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> 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.''
Instructions: 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
[[Page 42536]]
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register 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 Sec. 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 (Sec. 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 Sec.
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, Sec. 184.1366(d) requires that residual hydrogen
peroxide be removed during the processing of food by appropriate
physical and chemical means. In addition, Sec. 184.1366(c)
incorporates the requirement under Sec. 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 Sec.
184.1366 require a food additive regulation.
The food additive regulations were subsequently amended to add
Sec. 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, Sec.
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 Sec. 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 Sec. 173.356 is encompassed by the broader
uses proposed in this petition.
II. Evaluation of Safety
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 (e.g., during washing stages or
decomposition during drying stages). Given the unstable nature of
hydrogen peroxide and the requirement that residual hydrogen peroxide
be removed, we concur that the petitioned uses will not result in an
increased dietary exposure to hydrogen peroxide (Ref. 1).
In support of the petitioned uses of hydrogen peroxide, Cargill
summarized the available toxicological data and information on hydrogen
peroxide. Most of the data and information have been previously
submitted to and reviewed by FDA as part of other regulatory
submissions. None of these data and information raise new safety
concerns regarding the use of hydrogen peroxide under the intended
conditions of use. As the proposed uses are not expected to increase
dietary exposure to hydrogen peroxide, FDA has no safety concerns
regarding the petitioned uses of hydrogen peroxide (Ref. 2).
III. Incorporation by Reference
FDA is incorporating by reference the monograph for hydrogen
peroxide from the FCC, 14th ed., 2024, which was approved by the Office
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may purchase a copy of the material from the
[[Page 42537]]
U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD
20852, 1-800-227-8772, <a href="https://www.usp.org/">https://www.usp.org/</a>. You may inspect a copy at
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9
a.m. and 4 p.m., Monday through Friday.
The FCC 14 hydrogen peroxide monograph sets forth a standard for
purity and identity for hydrogen peroxide. The FCC 14 hydrogen peroxide
monograph provides specifications and analytical methodologies to
identify the substance and establish acceptable purity criteria.
As background, the current food additive regulation for the use of
hydrogen peroxide (Sec. 173.356) indicates that the additive must meet
the specifications of the hydrogen peroxide monograph in FCC 7. The
petitioner indicated that the hydrogen peroxide petitioned in FAP
2A4833 complies with the specifications in the monograph for hydrogen
peroxide in FCC 12. During our review of this petition, we noted that
the most recent edition of the FCC was FCC 14. The specifications for
hydrogen peroxide in FCC 14 are identical to those in both FCC 7 and
FCC 12. Therefore, we are amending Sec. 173.356(a) by adopting, and
incorporating by reference, the FCC 14 hydrogen peroxide monograph.
IV. Conclusion
Based on the relevant data available to FDA and information in the
petition, we conclude that there is reasonable certainty that no harm
will result from the use of hydrogen peroxide in food as an
antimicrobial agent, oxidizing and reducing agent, and bleaching agent,
and to remove sulfur dioxide, in accordance with good manufacturing
practice, and that such use will achieve its intended technical
effects. Additionally, we are amending Sec. 173.356(a) by adopting,
and incorporating by reference, the FCC 14 hydrogen peroxide monograph.
V. Public Disclosure
In accordance with 21 CFR 171.1(h), the petition and the documents
that we considered and relied upon in reaching our decision to approve
the petition will be made available for public disclosure (see FOR
FURTHER INFORMATION CONTACT). As provided in Sec. 171.1(h), FDA will
delete from the documents any materials that are not available for
public disclosure before making the documents available for inspection.
VI. Analysis of Environmental Impact
We have carefully considered the potential environmental effects of
this action. FDA has concluded that the action will not have a
significant impact on the human environment and that an environmental
impact statement is not required. FDA's finding of no significant
impact and the evidence supporting that finding, contained in an
environmental assessment, may be seen in the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
VII. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Objections
If you will be adversely affected by one or more provisions of this
order, you may file with the Dockets Management Staff (see ADDRESSES)
either electronic or written objections. You must separately number
each objection, and within each numbered objection you must specify
with particularity the provision(s) to which you object, and the
grounds for your objection. Within each numbered objection, you must
specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
Any objections received in response to this order may be seen in
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, and will be posted to the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348). This
order is not a statement regarding compliance with other sections of
the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C.
331(ll)) prohibits the introduction or delivery for introduction into
interstate commerce of any food that contains a drug approved under
section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exemptions in section 301(ll)(1) through (4)
of the FD&C Act applies. In our review of this petition, we did not
consider whether section 301(ll) of the FD&C Act or any of its
exemptions apply to food containing this additive. Accordingly, this
order should not be construed to be a statement that a food containing
this additive, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all food additive orders
authorizing new uses and therefore should not be construed to be a
statement of the likelihood that section 301(ll) of the FD&C Act
applies.
X. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. Memorandum from P. Wang, Chemistry Evaluation Branch, Division of
Food Ingredients, to K. Hall, Regulatory Review Branch, Division of
Food Ingredients, Human Foods Program (HFP), FDA, May 6, 2025.
2. Memorandum from J. Gingrich, Toxicology Review Branch, Division
of Food Ingredients, to K. Hall, Regulatory Review Branch, Division
of Food Ingredients, Human Foods Program (HFP), FDA, May 7, 2025.
List of Subjects in 21 CFR Part 173
Food additives, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for part 173 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Revise Sec. 173.356 to read as follows:
[[Page 42538]]
Sec. 173.356 Hydrogen peroxide.
Hydrogen peroxide (H<INF>2</INF>O<INF>2</INF>, CAS Reg. No. 7722-
84-1) may be safely used to treat food in accordance with the following
conditions:
(a) Hydrogen peroxide meets the specifications of Hydrogen
Peroxide, Food Chemicals Codex, 14th edition, effective June 1, 2024,
which is incorporated by reference into this section. The Director of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This incorporation
by reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA at: the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday;
phone: 240-402-7500; email: <a href="/cdn-cgi/l/email-protection#eea7acbcb1a38f9a8b9c878f82b1a7809f9b879c878b9dae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="da9398888597bbaebfa8b3bbb68593b4abafb3a8b3bfa99abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>. For
information on the availability of this material at NARA, visit
<a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email
<a href="/cdn-cgi/l/email-protection#6e081c4007001d1e0b0d1a0701002e000f1c0f40090118"><span class="__cf_email__" data-cfemail="670115490e0914170204130e0809270906150649000811">[email protected]</span></a>. The material may be obtained from the U.S.
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852;
phone: 800-822-8772; email: <a href="/cdn-cgi/l/email-protection#1d7b7e7e5d686e6d33726f7a"><span class="__cf_email__" data-cfemail="e2848181a2979192cc8d9085">[email protected]</span></a>; website: <a href="https://www.usp.org">https://www.usp.org</a>.
(b) The additive is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter, oxidizing and reducing agent defined
in Sec. 170.3(o)(22) of this chapter, and bleaching agent, and to
remove sulfur dioxide in accordance with good manufacturing practice.
(c) Residual hydrogen peroxide is removed by appropriate chemical
or physical means during the processing of food where it has been used.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16898 Filed 9-2-25; 8:45 am]
BILLING CODE 4164-01-P
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