BHA and BHT Food Safety
Are BHA and BHT safe in food?
Yes: regulators in the EU, US, Canada and Japan currently allow both BHA (E 320) and BHT (E 321) in food within set limits. But neither has an unqualified clean bill of health. EFSA's opinions flag combined exposure from food plus packaging (and, for BHT, high-consuming children). BHA is on California's Proposition 65 cancer list. The FDA has both under formal post-market safety reassessment right now.
Approach: I checked EU Regulation 1333/2008 Annex II, the EFSA re-evaluation opinions, US 21 CFR and FDA's food-substance inventories, Prop 65, CLP Annex VI and the CLH intentions registry, Health Canada's permitted additive lists and Japan's additive use standards. I also opened FDA's official reassessment pages.
EU: EFSA's safety assessments
- BHA (E 320): In 2011 EFSA raised the ADI from 0.5 to 1.0 mg/kg bw/day. It was based on effects in rat pups (NOAEL 100 mg/kg bw/day). EFSA judged the rat forestomach tumours behind the older ADI no longer relevant to humans, since humans have no forestomach [1].
- BHA exposure, 2012 update: Intake from food additive use alone generally stays below the ADI. Adding use in food packaging, however, "does exceed the ADI for most population groups." The packaging limit is a specific migration limit of 30 mg/kg food under Regulation (EU) No 10/2011 [2][3].
- BHT (E 321): In 2012 EFSA set an ADI of 0.25 mg/kg bw/day. It found BHT "not of concern with respect to genotoxicity" and said any carcinogenicity would have a threshold. The ADI is exceeded by high-consuming (95th percentile) children in Finland and the Netherlands. Counting packaging as well, children exceed it even at mean intake [4][5].
- JECFA, as cited by EFSA: ADI of 0-0.5 mg/kg bw for BHA (1989) [6] and 0-0.3 mg/kg bw for BHT (1996) [7].
EU: where they are permitted (Annex II, current consolidated text)
- BHA is authorised only in group entries, alone or combined with the other antioxidants in each group:
- With propyl gallate and TBHQ, in 14 categories. Examples: fats and oils for professional heat-treated food manufacture and frying fats (200) [8]; sauces (200, expressed on fat) [9]; dehydrated potatoes (25) [10].
- With propyl gallate, TBHQ and BHT, in 4 categories: chewing gum (400) [11]; solid and liquid food supplements, excluding those for infants and young children (400) [12][13]; seasonings and condiments (200) [14].
- BHT on its own is allowed at 100 in water-free fats and oils for professional heat-treated manufacture and frying [15], and in frying fat emulsions [16].
- Hazard classification: I found no CLP Annex VI harmonised classification and no CLH intention for either substance.
United States
- Current authorisations: Both are approved food additives. 21 CFR 172.110 covers BHA and 172.115 covers BHT, with combined BHA+BHT limits such as 50 ppm in dry breakfast cereals and 200 ppm in emulsion stabilizers for shortenings [17][18].
- GRAS listing: Both are also listed as GRAS, provided total antioxidants stay at or below 0.02% of fat or oil content (21 CFR 182.3169 and 182.3173) [19][20].
- FDA reassessment of BHA: FDA launched it on 10 February 2026 and cited the National Toxicology Program's view that BHA is "reasonably anticipated to be a human carcinogen" based on animal studies (FDA). FDA's tracker, updated 2 October 2026, lists BHA at "Scientific Assessment" (FDA list).
- FDA reassessment of BHT: It began on 12 May 2026 (FDA). The reopened comment period closed on 31 August 2026 (FDA). The tracker lists BHT at "Review of Information" (FDA list).
- California Prop 65: BHA has been listed as a carcinogen since 1 January 1990, on the basis of IARC as an authoritative body [21]. My search found no Prop 65 listing for BHT.
Canada and Japan
- Canada: List 11 of Health Canada's permitted additive lists allows both. Examples: fats, oils, lard and shortening up to 200 ppm combined [22]; dried breakfast cereals up to 50 ppm [23].
- Japan: Both are permitted. BHA is allowed at 0.2 g/kg in butter and in fats and oils, with BHA+BHT combined under one limit [24]. BHT is also allowed in chewing gum at 0.75 g/kg [25].
In short: At authorised levels, EFSA found no safety concern from food additive use for most of the population. The open issues are total exposure once packaging migration is counted (both substances), and children's intake of BHT. In the US the question is formally open: the outcome of FDA's reassessments could change the current authorisations.
I can also pull the ECHA C&L Inventory self-classifications or the IARC basis behind the Prop 65 listing if that would help.
Is the FDA reviewing them?
Yes. FDA has both BHA and BHT under formal post-market safety review, covering their use in food and in food-contact materials. Neither review has reached a risk-management action yet.
Approach: I checked FDA's List of Select Chemicals in the Food Supply Under FDA Review and FDA's post-market inventory of "not GRAS" determinations. I compared what I found with the FDA pages cited in my previous answer.
| BHA (butylated hydroxyanisole) | BHT (butylated hydroxytoluene) | |
|---|---|---|
| Review stage | Scientific Assessment | Review of Information |
| Review start date on the list | 2025-08-19 | 2025-08-19 |
| Public input docket | Request for Information FDA-2026-N-0302 | Request for Information FDA-2026-N-2526 |
| Most recent risk-management action | None ("NA") | None ("NA") |
| Source | [26] | [27] |
What FDA is asking for: For both substances, FDA wants stakeholder data on three things:
- dietary exposure
- safety and toxicity
- GRAS and prior-sanctioned uses
The scope covers both food use and food-contact materials [26][27].
What BHA covers: FDA's BHA entry describes food-grade BHA (CAS 25013-16-5) as mostly 3-BHA (CAS 121-00-6), with varying amounts of 2-BHA (CAS 88-32-4) [26].
Two different sets of dates: Both list entries give 19 August 2025 as the date the review started. FDA's press announcements, cited last time, give later launch dates for the public assessments:
The 2026 dates line up with the Federal Register docket numbers, so they look like the formal requests for information. The 2025 date appears to be when FDA first put the substances on its review list. The comment period on the BHT request reopened and closed on 31 August 2026 (FDA).
No "not GRAS" determination yet: I found neither substance in FDA's post-market inventory of determinations that a use is not GRAS. As of now, the authorisations in 21 CFR 172.110 and 172.115 and the GRAS listings in Part 182 still stand.
If it would help, I can pull the full Federal Register requests for information (FR Docs 2026-02761 and 2026-09507) to set out exactly which questions FDA put to stakeholders.
What foods have BHT?
BHT is permitted mainly in fats and oils, frying fats, chewing gum, dry breakfast cereals, dehydrated potato products, seasonings and food supplements. The exact list depends on the country, so the tables below cover the EU, US, Canada and Japan. These registers show where BHT is allowed, not which branded products actually contain it. To check a particular product, read its ingredient list for "BHT" or "E 321".
Approach: I checked the current consolidated EU Regulation 1333/2008 Annex II, US 21 CFR Parts 172, 181 and 182, Health Canada's List of Permitted Antioxidants (List 11), and Japan's food additive use standards. None of these registers holds data on actual use in marketed products.
EU (E 321): 6 food categories, limits in mg/kg
| Category | Food | Max level | Notes |
|---|---|---|---|
| 02.1 | Fats and oils essentially free from water | 100 | Only fats and oils for professional manufacture of heat-treated foods; frying oil and fat (excluding olive and pomace oil); lard, fish oil, beef, poultry and sheep fat [15] |
| 02.2.2 | Other fat and oil emulsions | 100 | Only frying fat [16] |
| 05.3 | Chewing gum | 400 | Group limit with propyl gallate, TBHQ and BHA [11] |
| 12.2.2 | Seasonings and condiments | 200 | Same group limit [14] |
| 17.1 | Food supplements, solid form (not for infants and young children) | 400 | Same group limit [12] |
| 17.2 | Food supplements, liquid form (not for infants and young children) | 400 | Same group limit [13] |
United States
- 21 CFR 172.115 (BHT alone or with BHA; total limit in ppm): [18]
- dehydrated potato shreds: 50
- dry breakfast cereals: 50
- emulsion stabilizers for shortenings: 200
- potato flakes: 50
- potato granules: 10
- sweetpotato flakes: 50
- Chewing gum base (21 CFR 172.615): BHT is allowed as an antioxidant up to 0.1% total antioxidant content [28].
- GRAS (21 CFR 182.3173): BHT can be used in any food under good manufacturing practice, provided total antioxidants stay at or below 0.02% of the fat or oil content, including essential (volatile) oil content [20]. This is why BHT can appear in a much wider range of fat-containing US foods than the specific list above suggests.
- Packaging migration (21 CFR 181.24): BHT is a prior-sanctioned antioxidant in food packaging, with a limit of addition to food of 0.005% [29].
Canada (List 11, item B.3): 11 entries
| Food | Max level (BHT alone; combined limits with BHA/propyl gallate also apply) |
|---|---|
| Margarine, calorie-reduced margarine | 0.01% of fat [30] |
| Chewing gum | 200 ppm [31] |
| Citrus oil flavours, dry flavours, essential oils | 1,250 ppm [32] |
| Citrus oils | 5,000 ppm [33] |
| Dehydrated potato products, dried breakfast cereals | 50 ppm [34] |
| Dry vitamin D preparations for addition to food | 10 mg/1,000,000 I.U. [35] |
| Fats and oils (except milk fat, olive oil, suet), lard, shortening | 200 ppm [36] |
| Parboiled rice | 35 ppm [37] |
| Partially defatted beef and pork fatty tissue | 65 ppm [38] |
| Unstandardized foods (excluding meat, fish and poultry preparations and the foods listed above) | 0.02% of fat [39] |
| Vitamin A liquids for addition to food | 5 mg/1,000,000 I.U. [40] |
Japan: 8 target foods
Limits are a combined total where BHA and BHT are used together [25]:
- butter: 0.2 g/kg
- chewing gum: 0.75 g/kg
- fats and oils: 0.2 g/kg
- dried fish and shellfish: 0.2 g/kg
- salted fish and shellfish: 0.2 g/kg
- frozen fish and shellfish (except products eaten raw): 1 g/kg of dip
- dried mashed potato: 0.2 g/kg
- frozen whale meat (except products eaten raw): 1 g/kg of dip
Common ground: Fats and oils and chewing gum are permitted in all four jurisdictions. Dried potato products are permitted in the US, Canada and Japan. Breakfast cereals are permitted in the US and Canada. The EU list is the narrowest, but it is the only one that names food supplements.
I can run the same breakdown for BHA, or add another jurisdiction such as Australia/New Zealand, if that would help.