Notice2026-09507
Butylated Hydroxytoluene (BHT); 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 for butylated hydroxytoluene (BHT) 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 BHT 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 BHT 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 27054-27056]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2526]
Butylated Hydroxytoluene (BHT); 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 for butylated
hydroxytoluene (BHT) 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 BHT 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 BHT 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:
[[Page 27055]]
<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-2526] for ``Butylated hydroxytoluene (BHT); 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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: John Steele, Office of Food Chemical
Safety, Dietary Supplements, and Innovation, Human Foods Program, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-
796-1976, 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 butylated hydroxytoluene (BHT) in human food and as a food contact
substance as part of a post-market assessment. As described below, BHT
(CAS No. 128-37-0) is used as an antioxidant in food to prevent the
spoilage of fats and oils and as an antioxidant in food contact
materials. Antioxidants are substances used to preserve food by
retarding deterioration, rancidity, or discoloration due to oxidation
(21 CFR 170.3(o)(3)).
All uses of BHT 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 (21 U.S.C. 321(s) and 348)).
As described below, BHT is authorized for use in food and as a food
contact substance in the U.S. through multiple regulatory pathways.
FDA lists BHT as GRAS for use as an antioxidant in food generally,
with the limitation that the total antioxidant content cannot exceed
0.02% of the total fat or oil content of the food (21 CFR 182.3173)
(these uses also appear to be the subject of uncodified prior sanctions
(see Ref. 1)). FDA also lists this antioxidant use of BHT as GRAS in
food for animals (21 CFR 582.3173); however, the focus of our post-
market assessment of BHT is on its safety for use in human food. BHT
has a prior-sanctioned use as an antioxidant when migrating from food
packaging material with a limit of addition to food of 0.005% (21 CFR
181.24). We are not aware of any other GRAS conclusions or prior
sanctions for the use of BHT in food or as a food contact substance.
BHT is authorized as a direct food additive when used as an
antioxidant, alone or in combination with butylated hydroxyanisole
(BHA), in certain foods with specified limitations (21 CFR 172.115).
BHT is also permitted as a direct food additive in chewing gum base
when used as an antioxidant, alone or in combination with BHA or propyl
gallate, such that the total antioxidant content does not exceed 0.1%
of the gum base (21 CFR 172.615(a)) (we have also issued a Request for
Information as part of our post-market assessment of the safety of BHA
in food (see 91 FR 6227, Feb. 11, 2026)).
BHT is authorized as an indirect or secondary direct food additive
or a constituent of food additives for use as an antioxidant in food
contact materials, including in defoaming agents for processing beet
sugar and yeast, such that the total antioxidant content does not
exceed 0.1% by weight of defoamer (21 CFR 173.340(a)(3)); adhesives (21
CFR 175.105(c)(5)); pressure sensitive adhesives in labels and/or tapes
applied to poultry, dry food, and processed, frozen, dried, partially
dehydrated fruits or vegetables, or raw fruits or vegetables (21 CFR
175.125)(a)(4),(b)(2)); resinous and polymeric coatings (21 CFR
175.300(b)(3)(xxx), 175.380(a), 175.390(b)(2)); components of paper and
paperboard in contact with aqueous and fatty foods (21 CFR
176.170(a)(4)); defoaming agents used in the manufacture of paper and
paperboard (21 CFR 176.210(d)(3)); semirigid and
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rigid acrylic and modified acrylic plastics (21 CFR 177.1010(a)(5));
closures with sealing gaskets for food containers (21 CFR 177.1210(b));
ethylene-vinyl acetate copolymers (21 CFR 177.1350(a)(1)(iii)); resin-
bonded filters (21 CFR 177.2260(d)(2)); rubber articles intended for
repeated use (21 CFR 177.2600(c)(4)(iii)); polymers used in the
manufacture of articles or components of articles intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, such that it does not exceed
5% by weight of stabilizer formulation (21 CFR 178.2010(b)); defoaming
agents used as optional adjuvants in the production of animal glue (21
CFR 178.3120(d)(3)); machinery lubricants with incidental food contact
(21 CFR 178.3570(a)(3)); polyethylene film, such that it does not
exceed 1% by weight of polyethylene polymer and such that the film is
not subjected to a dose of radiation exceeding 60 kilograys by gamma,
electron beam, or X-radiation (21 CFR 179.45(d)(2)(i)).
We also note that BHT is listed as an optional ingredient in
enriched parboiled rice (21 CFR 137.350(a)(4)). BHT is also listed for
use in the United States Department of Agriculture (USDA)'s
specifications for butteroil (7 CFR 58.305(b)), and USDA's and FDA's
standards of identity for margarine (9 CFR 319.700(b)(6), 21 CFR
166.110(b)(5)). These uses are within the scope of the GRAS regulation
at 21 CFR 182.3173 or uncodified prior sanctions (Ref. 1).
As part of our systematic review of select chemicals in food, FDA
is beginning a post-market assessment of the safety of BHT 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 BHT is safe
under its conditions of use in food or as a food contact substance
considering the most recent science. While FDA previously concluded the
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 BHT currently used in food and as a food
contact substance. 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 BHT 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. 2), the Codex General
Standard for Food Additives (Ref. 3);
2. Typical and maximum use levels of BHT in each applicable
general food category;
3. Information on the current food contact uses of BHT,
including data on migration of BHT from food contact materials into
food;
4. Subpopulations with high BHT dietary exposure or particular
safety concerns relevant to food and food contact uses of BHT;
5. Other dietary sources of BHT, such as dietary supplements,
natural occurrence in common foods, residues in animal products, or
as a contaminant in food or drinking water;
6. Market share of foods in each applicable general food
category and food contact materials that are formulated with BHT;
7. Biomonitoring data for BHT or its metabolites;
8. Updated market disappearance or poundage data for BHT;
9. Information on potential chemically or pharmacologically
related substances used in food or as food contact substances;
10. Safety data relevant to use of BHT in food or as a food
contact substance, especially unpublished data;
11. Documentation of GRAS conclusions or prior sanctions for
uses of BHT in food or as a food contact substance that are
different from those described above;
12. Information that may support the conclusion that BHT 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. Citizen Petition from Roger D. Middlekauff, dated December 23,
1986, available at <a href="http://regulations.gov">regulations.gov</a> in Docket No. FDA-2026-N-2526.
2. What We Eat in America Food Categories, available at <a href="https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/">https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/dmr-food-categories/</a>.
3. 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. 2026-09507 Filed 5-12-26; 8:45 am]
BILLING CODE 4164-01-P
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