Notice2026-09508
Azodicarbonamide (ADA); Request for Information
Primary source
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Published
May 13, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is requesting information on the current uses and safety data of azodicarbonamide (ADA) in human food and as a food contact substance. We are requesting this information as part of our systematic process for conducting post- market assessments of chemicals in food. We are conducting a post- market assessment of the safety of ADA in food, considering the latest state of the science. We intend to use the information received and any other available, relevant information to determine if ADA remains safe under its current conditions of use in food and as a food contact substance.
Full Text
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<title>Federal Register, Volume 91 Issue 92 (Wednesday, May 13, 2026)</title>
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[Federal Register Volume 91, Number 92 (Wednesday, May 13, 2026)]
[Notices]
[Pages 27060-27062]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09508]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4126]
Azodicarbonamide (ADA); Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: The Food and Drug Administration (FDA or we) is requesting
information on the current uses and safety data of azodicarbonamide
(ADA) in human food and as a food contact substance. We are requesting
this information as part of our systematic process for conducting post-
market assessments of chemicals in food. We are conducting a post-
market assessment of the safety of ADA in food, considering the latest
state of the science. We intend to use the information received and any
other available, relevant information to determine if ADA remains safe
under its current conditions of use in food and as a food contact
substance.
DATES: Either electronic or written comments and scientific data and
information on the notice must be submitted by July 13, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 13, 2026. Comments 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 comments 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. Comments 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 comment will be
made public, you are solely responsible for ensuring that your comment
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 comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment 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 comments submitted to the Dockets
Management Staff, FDA will post your comment, 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-2026-N-4126 for ``Azodicarbonamide (ADA); Request for
Information.'' Received comments, those 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 a comment with
confidential information that you do not wish to be made publicly
available, submit your comments 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
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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: Daniel Hlavaty, Office of Food
Chemical Safety, Dietary Supplements, and Innovation, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 301-796-1481, or Lauren Kleinman, Office of Policy and
International Engagement, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting information on the current uses and safety data
for azodicarbonamide (ADA) in human food and as a food contact
substance as part of a post-market assessment. ADA (CAS No. 123-77-3)
is used as a whitening agent in cereal flour and as a dough conditioner
in breadmaking and has applications in manufacturing food contact
materials.
All uses of ADA in food or as a food contact substance must be
authorized for that use through a food additive regulation or an
effective food contact notification, or be excluded from regulation as
a food additive, for example, because such use is generally recognized
as safe (GRAS) or is prior sanctioned (see Sections 201(s) and 409 of
the Federal Food, Drug, and Cosmetic Act). As described below, these
uses of ADA in food and as a food contact substance in the U.S. are
authorized by FDA's food additive regulations.
ADA is authorized as a direct food additive when used as an aging
and bleaching ingredient in cereal flour and as a dough conditioner in
bread baking in a total amount not to exceed 0.0045 percent (45 parts
per million; 2.05 grams per 100 pounds of flour) (21 CFR 172.806). It
is listed as an optional ingredient in the standards of identity for
bread, rolls, and buns (21 CFR 136.110); flour (21 CFR 137.105); and
whole wheat flour (21 CFR 137.200) when used in accordance with the
regulations for ADA in 21 CFR 172.806. ADA is also permitted as an
indirect food additive when used in closures with sealing gaskets for
food containers (21 CFR 177.1210), rubber articles intended for
repeated use (21 CFR 177.2600), and adjuvant substances used in the
manufacture of foamed plastics (21 CFR 178.3010). We are not aware of
any prior sanctions or conclusions that the use of ADA is GRAS in food
or for food contact use.
As part of our systematic review of chemicals in food, FDA is
beginning a post-market assessment of the safety of ADA as used in food
and as a food contact substance. (see <a href="https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review">https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review</a>).
This assessment supports the Make America Healthy Again Commission's
recommendation to implement an evidence-based systematic process for
post-market assessment of chemicals in food (see <a href="https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf</a>). The objective of our assessment is to determine if ADA is safe
under its conditions of use in food or as a food contact substance
considering the most recent science. While FDA previously concluded
authorized uses to be safe, new information may require reconsideration
of the regulatory status or the safe uses of a substance in or on food.
II. Request for Information
FDA is requesting information on uses, use levels, dietary
exposure, and safety data on ADA currently used in food and as a food
contact substance. This includes decomposition products of ADA, which
are the chemicals formed when ADA breaks down, such as during
breadmaking. Information from food manufacturers on uses and levels is
crucial for food chemical assessments. We encourage food manufacturers
to participate in this data call, with options for aggregated
submissions through trade groups or other collaborations. We do not
need information about individual products and their recipes, but
rather data about the levels of use in general product categories.
Voluntary submission of data and information on current uses and use
levels will help to refine our dietary exposure assessments. We use
maximizing assumptions to estimate dietary exposure (see, e.g.,
``Guidance for Industry: Estimating Dietary Intake of Substances in
Food,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-estimating-dietary-intake-substances-food">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-estimating-dietary-intake-substances-food</a>). Without refinements assisted by manufacturer use
information, this may lead to overestimation of dietary exposure that
could impact authorizations for the chemical's use in food or as a food
contact substance.
Specifically, FDA requests the following:
1. General food categories in which ADA is used (for example,
cookies, soft drinks, other categories listed in 21 CFR 170.3(n)),
USDA's What We Eat in America survey (Ref. 1), or the Codex General
Standard for Food Additives (Ref. 2));
2. Typical and maximum use levels of ADA in each applicable
general food category;
3. Information on actual or expected residual levels of
decomposition products of ADA (including semicarbazide and ethyl
carbamate) in foods and food contact materials where ADA is used;
4. Information on the current food contact uses of ADA,
including data on migration of ADA or its decomposition products
from food contact materials into food;
5. Subpopulations with high dietary exposure to ADA or its
decomposition products or particular safety concerns relevant to
food and food contact uses of ADA;
6. Other dietary sources of ADA or its decomposition products,
such as dietary supplements, natural occurrence in common foods,
residues in animal products, or as contaminants in food or drinking
water;
7. Market share of foods in each applicable general food
category and food contact materials that are formulated with ADA;
8. Biomonitoring data for ADA, its decomposition products, or
its metabolites;
9. Updated market disappearance or poundage data for ADA;
10. Information on potential chemically or pharmacologically
related substances used in food or as a food contact substance;
11. Safety data relevant to use of ADA in food or as a food
contact substance, including data pertaining to its decomposition
products, and especially unpublished data;
12. Documentation of GRAS conclusions or prior sanctions for
uses of ADA in food or as a food contact substance;
13. Information that may support the conclusion that ADA is no
longer used for one or more of its authorized intended uses in food
or as a food contact substance.
III. References
The following references are on display at 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>. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. What We Eat in America Food Categories, available at https://
www.ars.usda.gov/
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northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-
research-center/food-surveys-research-group/docs/dmr-food-
categories/.
2. Codex General Standard for Food Additives, available at <a href="https://www.fao.org/gsfaonline/foods/index.html">https://www.fao.org/gsfaonline/foods/index.html</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09508 Filed 5-12-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 13, 2026.
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