BHA and BHT in food under US rules and FDA's 2026 review

BHA and BHT in food

BHA (butylated hydroxyanisole) and BHT (butylated hydroxytoluene) are synthetic antioxidants used to keep fats and oils from going rancid. BHA and BHT in food remain permitted as GRAS preservatives under 21 CFR 182.3169 and 21 CFR 182.3173, and as food additives under 21 CFR 172.110 and 21 CFR 172.115. FDA is reassessing both in 2026, and the FDA review list records no risk management action for either substance.

What BHA and BHT are

Both are used in fats, oils and fat-containing foods, and in food packaging. Food-grade BHA (CAS 25013-16-5) is mostly the 3-isomer (CAS 121-00-6) with varying amounts of the 2-isomer (CAS 88-32-4), according to FDA's review list. BHT is CAS 128-37-0 in the FDA SCOGS database. FDA says BHA was listed as GRAS in 1958 and approved as a food additive in 1961 (FDA announcement).

What the 1970s SCOGS reviews concluded

In the 1970s the Select Committee on GRAS Substances (SCOGS), scientists outside FDA, reviewed GRAS substances one by one. The SCOGS database records:

Type 3 means the committee found no evidence in the available information of a hazard to the public at the use levels then current, but uncertainties remained that called for more studies (FDA SCOGS page). That 1970s finding sits in the SCOGS record, separate from the 2026 reassessment.

Current US rules for BHA and BHT

US rules list both substances as GRAS preservatives and also authorize specified food additive uses. Limits differ by food.

The GRAS listings are 21 CFR 182.3169 for BHA and 21 CFR 182.3173 for BHT. They allow use as a chemical preservative under good manufacturing practice when total antioxidant content is not over 0.02% of the fat or oil content, including essential (volatile) oil. That is 0.02% of the fat, not of the whole food.

The food additive approvals are 21 CFR 172.110 (BHA) and 21 CFR 172.115 (BHT). They set limits per food, counted as total BHA plus BHT:

Section 172.110 adds BHA-only uses: active dry yeast at 1,000 ppm, dry diced glazed fruit at 32 ppm, dry mixes for beverages and desserts at 90 ppm, and the drinks and desserts made from those mixes at 2 ppm. The required purity is at least 98.5% for BHA. Section 172.115 requires at least 99% purity for BHT. Other parts of Title 21 name them too:

• Chewing gum base: BHA, BHT and propyl gallate, with antioxidant content not over 0.1% (21 CFR 172.615).
• Margarine: BHA, BHT, gallates, ascorbyl palmitate and ascorbyl stearate, alone or combined, at no more than 0.02% (21 CFR 166.110).
• Enriched parboiled rice: BHT at not more than 0.0033%, with the label statement "Butylated hydroxytoluene added as a preservative" (21 CFR 137.350).
• Flavoring substances: BHA up to 0.5% of the essential (volatile) oil content (21 CFR 172.515).
• Food packaging: both are prior-sanctioned antioxidants. When they migrate from packaging, the limit of addition to food is 0.005% (21 CFR 181.24).

FDA's 2025-2026 reassessment

On May 15, 2025, FDA announced a stronger post-market chemical review program and said BHA, BHT and azodicarbonamide (ADA) would go on its updated review list (FDA). The review list gives August 19, 2025 as the start date for both, when FDA said it would seek stakeholder data (FDA update). The formal reassessments came later, and on different dates:

• BHA: launched February 10, 2026, covering food and food contact uses (FDA). The request for information ran in the Federal Register on February 11, 2026 (91 FR 6227, docket FDA-2026-N-0302), and comments closed April 13, 2026 (Federal Register).
• BHT: launched May 12, 2026, alongside ADA, the day FDA finalized its post-market assessment framework (FDA). Its request for information (91 FR 27054, docket FDA-2026-N-2526) was published May 13, 2026, with comments first due July 13, 2026 (Federal Register). FDA reopened comments on July 30, 2026 until August 31, 2026, and that window is now closed (Federal Register).

Both requests asked for data on dietary exposure, toxicity and GRAS and prior-sanctioned uses. The review list places BHA at "Scientific Assessment" and BHT at "Review of Information". The risk management column reads "NA" for both.

Neither substance has a proposed rule or risk management action yet, so the CFR limits above still apply. Watch the FDA review list for changes.

Does BHA or BHT cause cancer?

The NTP listing for BHA rests on forestomach tumours in rats of both sexes, male mice and hamsters (NTP profile). And FDA cited that finding when it opened the BHA review (FDA announcement). IARC's groupings are on its classification list. Prop 65 status is on the OEHHA BHA page and the Prop 65 list.

EFSA reads the same tumour data differently. In 2011 it raised the BHA ADI from 0.5 to 1.0 mg/kg bw/day and judged the rat forestomach tumours not relevant to humans, who have no forestomach (EFSA Journal, panel minutes). For BHT, EFSA found no genotoxicity concern in 2012 and set the ADI at 0.25 mg/kg bw/day from a NOAEL of 25 mg/kg bw/day (EFSA minutes).

EFSA's 2012 estimates placed BHT exposure above its ADI for children in Finland and the Netherlands at the 95th percentile (EFSA minutes). For BHA, food additive use alone generally stayed under the ADI, but adding food-contact materials pushed exposure over it for most groups (EFSA statement).

BHA and BHT in the EU

In the EU, BHA is E 320 and BHT is E 321 under Regulation (EC) No 1333/2008. BHT alone is allowed at 100 mg/kg in certain fats and oils, including frying fat, lard and fish oil. BHA only appears in group limits with propyl gallate and TBHQ, such as 200 mg/kg in frying fats and 25 mg/kg in dehydrated potatoes.

What foods contain BHA and BHT

Official registers show where the two are allowed, not which brands use them. The BHA and BHT food additive rules and the food-specific provisions above cover:

• dry breakfast cereals
• dehydrated potato products (flakes, shreds, granules, sweet potato flakes)
• emulsion stabilizers for shortenings, margarine and chewing gum base
• active dry yeast, dry drink and dessert mixes, and glazed fruit (BHA)
• enriched parboiled rice (BHT)

For BHT in cereal, the cap is 50 ppm total BHA plus BHT, not 50 ppm of each. Fats and oils can also carry either antioxidant under the GRAS cap of 0.02% of the fat or oil content (21 CFR 182.3169, 21 CFR 182.3173). Packaging can contribute them only up to the 0.005% limit of addition to food (21 CFR 181.24).

For a specific product, check the ingredient list for BHA or BHT rather than assuming an authorized use is present. RegAffairs AI's answer on BHA and BHT links the regulatory claims to stored source documents.