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Our Verdict: USE WITH CAUTION

Butylated Hydroxytoluene

E-numberE321CAS128-37-0FDA GRAS

Some regulatory concerns have been raised

This additive has been flagged by at least one major regulatory agency or peer-reviewed study. Review the evidence below before forming conclusions.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Restricted

EFSA

Butylated Hydroxytoluene — food additive

Butylated Hydroxytoluene (BHT) is a synthetic antioxidant widely used in food processing to prevent fat and oil oxidation, extending shelf life and maintaining product quality. It also functions as a flavor enhancer and is approved by the FDA as a Generally Recognized as Safe (GRAS) food additive.

US Status

Approved

FDA

EU Status

Restricted

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

Restricted in 4 jurisdictions
United States
ApprovedFDA
European Union
RestrictedEFSA
United Kingdom
RestrictedUK FSA
Canada
UnknownHealth Canada
Australia
RestrictedFSANZ
Japan
RestrictedMHLW
South Korea
ApprovedMFDS
Brazil
ApprovedANVISA
China
ApprovedNHC / GB 2760
India
ApprovedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Butylated Hydroxytoluene?

Butylated Hydroxytoluene, commonly known as BHT, is a synthetic organic compound with the chemical formula C₁₅H₂₄O. Identified by CAS Number 128-37-0, BHT is a hindered phenol that functions primarily as an antioxidant in food applications. The compound was first synthesized in the mid-20th century and has been used extensively in the food industry for decades. BHT appears as a white to off-white crystalline powder and is soluble in fats and oils, making it particularly effective in lipid-containing food products.

Common Uses

BHT is incorporated into a wide range of food products to prevent the oxidative degradation of fats and oils. Common applications include:

- Baked goods and cake mixes

- Cereals and grain products

- Chewing gum

- Potato flakes and other dehydrated potatoes

- Vegetable oils and shortenings

- Processed meat products

- Snack foods

- Beer

The additive functions by donating hydrogen atoms to free radicals, thereby interrupting oxidation chains that lead to rancidity, off-flavors, and degradation of nutritional quality. Additionally, BHT serves as a flavor enhancer and flavoring agent adjuvant, contributing to overall product stability and sensory characteristics.

Safety Assessment

BHT has been extensively studied for safety since its introduction. The FDA granted GRAS (Generally Recognized as Safe) status to BHT, indicating that it is recognized as safe by qualified experts under conditions of its intended use. The FDA's database records zero adverse events associated with BHT consumption and zero recalls linked to BHT contamination or safety concerns.

Toxicological studies have evaluated BHT through multiple endpoints including acute, subchronic, and chronic exposure scenarios. Research has examined potential effects on organ systems, reproductive outcomes, and genetic material. Regulatory agencies, including the FDA and European Food Safety Authority (EFSA), have reviewed available scientific data and determined acceptable daily intake levels. The EFSA established an Acceptable Daily Intake (ADI) of 0-0.5 mg/kg body weight.

BHT is rapidly absorbed and metabolized in the body, primarily through hepatic pathways. The compound is eliminated relatively quickly, with minimal bioaccumulation potential. Most toxicological endpoints tested in animals at relevant doses have not demonstrated adverse effects at levels consistent with food use.

Regulatory Status

BHT maintains GRAS status in the United States under FDA regulations and is approved for use in specified food categories. The FDA Code of Federal Regulations (21 CFR 182.3521) permits BHT use in foods with appropriate limitations on maximum levels—typically not to exceed 0.02% by weight of the finished food product.

Internationally, BHT approval varies by jurisdiction. It is approved in the United States, Canada, and Japan. However, some European nations maintain more restrictive positions, reflecting different regulatory philosophies regarding synthetic additives. The European Union does not include BHT on its approved additives list for food use, though it remains approved for use in cosmetics and other applications.

Key Studies

Significant research has informed BHT's safety profile:

- **Carcinogenicity assessments**: Multiple animal studies examining tumor development have shown no clear evidence of carcinogenicity at levels relevant to human dietary exposure.

- **Metabolic studies**: Research has documented BHT's rapid metabolism and excretion patterns, supporting the conclusion that bioaccumulation is minimal.

- **Reproductive/developmental toxicity**: Studies in animal models at doses significantly higher than dietary exposure levels have not demonstrated adverse reproductive or developmental effects at approved food use levels.

- **Regulatory reviews**: Comprehensive safety assessments by the FDA, EFSA, and Joint FAO/WHO Expert Committee on Food Additives (JECFA) have evaluated the totality of evidence.

The scientific consensus supports the safety of BHT when used within established regulatory limits in food applications.

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Brands that use Butylated Hydroxytoluene

14 brands in our database list Butylated Hydroxytoluene as an ingredient in at least one product.

Frequently Asked Questions

What is Butylated Hydroxytoluene?

Butylated Hydroxytoluene (BHT) is a synthetic antioxidant widely used in food processing to prevent fat and oil oxidation, extending shelf life and maintaining product quality. It also functions as a flavor enhancer and is approved by the FDA as a Generally Recognized as Safe (GRAS) food additive.

Is Butylated Hydroxytoluene safe?

Butylated Hydroxytoluene is currently rated "caution" based on FDA and EFSA data. It is approved in the US and restricted in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Butylated Hydroxytoluene banned in any country?

Butylated Hydroxytoluene is approved in the United States and restricted in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.

Further reading on Butylated Hydroxytoluene

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