FDA Status
GRAS
BHT (Butylated Hydroxytoluene) (E321), CAS 128-37-0, is a preservative additive holding a composite safety score of 3 out of 5 (Mixed Evidence). The U.S. Food and Drug Administration currently classifies it as GRAS, while the European Union lists it as Approved. It is most commonly used as Cereal, snack foods, packaging materials.
No U.S. state has enacted specific legislation targeting BHT (Butylated Hydroxytoluene) to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for BHT (Butylated Hydroxytoluene), which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2012-03-07. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | GRAS | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E321 | EU additive register |
| CAS Number | 128-37-0 | CAS Registry |
| Category | Preservative | FDA functional class |
| Composite Safety Score | 3 / 5 (Mixed Evidence) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | Open Food Facts (US) |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
3.0 / 5
Composite Safety Mixed Evidence
Safety Score: 3 out of 5
Safety Rating 60.0%
EU Status
Approved
E321
U.S. State Regulations
0 states
None enacted
Safety Assessment
BHT (Butylated Hydroxytoluene) receives a safety score of 3/5 (Mixed Evidence) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies BHT (Butylated Hydroxytoluene) as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
Research has identified 1 area of health concern associated with BHT (Butylated Hydroxytoluene). Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is BHT (Butylated Hydroxytoluene)?
Synthetic antioxidant similar to BHA.
Health Concerns
- Mixed evidence. Some studies show tumor promotion.
Common Uses
Cereal, snack foods, packaging materials
Frequently Asked Questions
Is BHT (Butylated Hydroxytoluene) safe to consume?
BHT (Butylated Hydroxytoluene) has a safety score of 3/5 (Mixed Evidence). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is BHT (Butylated Hydroxytoluene) used for in food?
BHT (Butylated Hydroxytoluene) is commonly used as: Cereal, snack foods, packaging materials. It belongs to the Preservative category of food additives.
Is BHT (Butylated Hydroxytoluene) banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting BHT (Butylated Hydroxytoluene). However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of BHT (Butylated Hydroxytoluene)?
The FDA classifies BHT (Butylated Hydroxytoluene) as "GRAS", while the EU status is "Approved" (E321). The FDA and EU use separate evaluation frameworks — the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with BHT (Butylated Hydroxytoluene)?
Research has identified the following health concerns for BHT (Butylated Hydroxytoluene): Mixed evidence. Some studies show tumor promotion.. These findings inform its safety score of 3/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for BHT (Butylated Hydroxytoluene) calculated?
The safety score of 3/5 for BHT (Butylated Hydroxytoluene) is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
Explore PlainIngredients
Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Resources
Related Preservative Ingredients
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial