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 ( printed page 27056) 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 https://www.fda.gov/​food/​food-chemical-safety/​list-select-chemicals-food-supply-under-fda-review). 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 https://www.whitehouse.gov/​wp-content/​uploads/​2025/​09/​The-MAHA-Strategy-WH.pdf). 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 https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-estimating-dietary-intake-substances-food). 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 https://www.regulations.gov. 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 regulations.gov in Docket No. FDA-2026-N-2526.

2. What We Eat in America Food Categories, available at https://www.ars.usda.gov/​northeast-area/​beltsville-md-bhnrc/​beltsville-human-nutrition-research-center/​food-surveys-research-group/​docs/​dmr-food-categories/​.

3. Codex General Standard for Food Additives, available at https://www.fao.org/​gsfaonline/​foods/​index.html.