Our Verdict: SAFE

Glycerol Tributyrate

CAS60-01-5

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Glycerol Tributyrate — food additive

Glycerol tributyrate is a fatty acid ester composed of glycerol and butyric acid, used as a flavoring agent and solvent in food products. It imparts a characteristic butter-like flavor and helps distribute flavoring compounds in food formulations.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Glycerol Tributyrate?

Glycerol tributyrate, also known as tributyrin, is an organic compound with the CAS number 60-01-5. It is formed through the esterification of glycerol with butyric acid (a naturally occurring short-chain fatty acid). The molecule consists of a three-carbon glycerol backbone with three butyrate groups attached. Glycerol tributyrate exists as a colorless to pale yellow liquid with a characteristic buttery odor and taste.

This additive belongs to the class of fatty acid esters, which are commonly used in food manufacturing for their functional and sensory properties. The butyric acid component is the same compound found naturally in butter, contributing to its butter-like flavor profile.

Common Uses

Glycerol tributyrate is primarily used in the food industry as a flavoring agent and flavor adjuvant. Its main applications include:

- Butter and dairy flavoring in processed foods such as baked goods, snacks, and confectionery

- Solvent or vehicle for distributing other flavor compounds more evenly throughout food products

- Enhancement of fat-soluble flavoring components in margarine, spreads, and oil-based products

- Flavoring support in seasonings and seasoning blends

The compound's ability to dissolve both lipophilic and hydrophilic flavor compounds makes it particularly valuable as a solvent in complex flavor formulations. It is typically used in small quantities, measured in parts per million (ppm), in final food products.

Safety Assessment

Glycerol tributyrate has not been formally designated as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration, though it remains permitted for use in food flavoring applications. The FDA has recorded zero adverse events associated with this additive and zero recalls related to its use, indicating a historical safety profile without documented incidents of consumer harm.

As a fatty acid ester, glycerol tributyrate's safety profile is supported by the generally recognized safety of its component parts—glycerol and butyric acid—both of which have extensive use histories in food applications. Glycerol is widely used in numerous food products, and butyric acid occurs naturally in many foods, particularly dairy products.

Since this compound is used in small amounts as a flavoring adjuvant, human dietary exposure is limited. The ester structure means the compound is metabolized similarly to other dietary fats and is broken down into its component parts during digestion.

Regulatory Status

In the United States, glycerol tributyrate is regulated under the FDA's Food Additive Regulations as a synthetic flavoring substance. While not GRAS-listed, it is permitted for use in food and is subject to the FDA's existing regulations governing food additives and flavorings.

The European Food Safety Authority (EFSA) has evaluated fatty acid esters, including glycerol tributyrate, as food additives. Regulatory acceptance varies by jurisdiction, with some countries permitting its use in flavoring formulations while others maintain more restrictive policies.

As with all food additives, manufacturers using glycerol tributyrate must comply with applicable regulations in each market where their products are sold, including compliance with maximum use levels and proper labeling.

Key Studies

Limited peer-reviewed literature specifically examines glycerol tributyrate's safety in food applications. However, the safety of structurally similar fatty acid esters has been evaluated extensively. Research on short-chain fatty acids and their esters demonstrates they are metabolized through normal dietary pathways without accumulation in tissues.

The absence of adverse events and recalls in FDA records over decades of use suggests that glycerol tributyrate, when used at appropriate levels in food flavoring, has not presented detectable safety concerns in the food supply. Continued monitoring and adherence to established use levels remain appropriate regulatory practice.

Frequently Asked Questions

What is Glycerol Tributyrate?

Glycerol tributyrate is a fatty acid ester composed of glycerol and butyric acid, used as a flavoring agent and solvent in food products. It imparts a characteristic butter-like flavor and helps distribute flavoring compounds in food formulations.

Is Glycerol Tributyrate safe?

Glycerol Tributyrate is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Glycerol Tributyrate banned in any country?

Glycerol Tributyrate is approved in the United States and not_evaluated 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.