Our Verdict: RATING UNKNOWN

Propyleneglycol Monobutyrate

CAS29592-95-8

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Propyleneglycol Monobutyrate — food additive

Propyleneglycol Monobutyrate is a synthetic flavoring compound derived from propylene glycol and butyric acid. It is used in food manufacturing as a flavoring agent or flavor adjuvant to enhance or modify taste profiles in various food products.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Propyleneglycol Monobutyrate?

Propyleneglycol Monobutyrate (CAS Number: 29592-95-8) is a synthetic chemical compound created through the esterification of propylene glycol with butyric acid. It belongs to the class of propylene glycol esters, which are widely used in food manufacturing. The compound is a colorless to pale yellow liquid with chemical properties that make it useful as both a flavoring agent and a flavor adjuvant in food formulations.

Common Uses

Propyleneglycol Monobutyrate is primarily employed in the food industry as a flavoring agent or adjuvant. Flavor adjuvants are substances that enhance, modify, or supplement the flavor profiles of food products without necessarily contributing a distinct taste themselves. This additive may be used in processed foods, beverages, dairy products, and other food categories where flavor enhancement is desired. Like other propylene glycol esters, it serves as a vehicle for flavor compounds and can help distribute flavoring agents more evenly throughout food matrices.

Safety Assessment

Propyleneglycol Monobutyrate has not received GRAS (Generally Recognized As Safe) status from the FDA, meaning it has not been formally affirmed through the GRAS notification process. However, this does not indicate that the compound is unsafe; rather, it reflects the regulatory pathway and submission history for this particular additive. According to available FDA data, there have been zero reported adverse events associated with this compound and zero FDA recalls involving its presence in food products.

The safety profile of propylene glycol esters as a class is generally well-established. Propylene glycol itself is widely used in food, pharmaceuticals, and cosmetics and has an extensive safety history. Butyric acid is a naturally occurring short-chain fatty acid found in butter and other foods. The esterification of these two components creates a compound with properties distinct from its precursors, but the safety evaluation would consider the metabolic fate and toxicological data available for similar compounds in this chemical class.

Limited published toxicological data exists specifically for Propyleneglycol Monobutyrate in peer-reviewed literature. The absence of adverse event reports and recalls suggests that any use of this additive in food has not raised safety concerns sufficient to trigger regulatory action or consumer complaints documented with the FDA.

Regulatory Status

In the United States, Propyleneglycol Monobutyrate operates under the FDA's authority to regulate food additives. Its lack of GRAS status means it would need to be included in food formulations under a different regulatory framework if used commercially. The FDA maintains a Color Additives Status List and Food Additives Status List; the regulatory classification of this specific compound should be verified through current FDA regulations or guidance documents.

Regulatory status in other jurisdictions, such as the European Union under EFSA oversight, may differ from FDA classification. International food manufacturers seeking to export products containing this ingredient should verify compliance with applicable regulations in target markets.

Key Studies

Published scientific literature specifically evaluating Propyleneglycol Monobutyrate is limited. Most safety information relevant to this compound would be extrapolated from:

- Studies on propylene glycol and its derivatives, which demonstrate low toxicity in typical food use levels

- Research on butyric acid and its salts, which have established safety profiles

- General toxicological data on ester compounds in the propylene glycol family

The chemical stability, metabolic degradation, and bioavailability of this specific ester would be important considerations in a comprehensive safety assessment. Researchers and regulators evaluating this additive would typically examine absorption, distribution, metabolism, and excretion (ADME) data to understand its behavior in the human body.

Further research and formal toxicological studies may be warranted if this additive is proposed for broader or increased use in food products.

Frequently Asked Questions

What is Propyleneglycol Monobutyrate?

Propyleneglycol Monobutyrate is a synthetic flavoring compound derived from propylene glycol and butyric acid. It is used in food manufacturing as a flavoring agent or flavor adjuvant to enhance or modify taste profiles in various food products.

Is Propyleneglycol Monobutyrate safe?

Propyleneglycol Monobutyrate is currently rated "unknown" 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 Propyleneglycol Monobutyrate banned in any country?

Propyleneglycol Monobutyrate 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.