Our Verdict: RATING UNKNOWN

Propyleneglycol Dibutyrate

CAS50980-84-2

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 Dibutyrate โ€” food additive

Propyleneglycol Dibutyrate (PGDB) is a synthetic flavoring compound derived from propylene glycol and butyric acid. It functions as a flavoring agent and adjuvant in food products, enhancing taste profiles in various applications.

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 Dibutyrate?

Propyleneglycol Dibutyrate (PGDB), identified by CAS Number 50980-84-2, is a synthetic ester compound created through the chemical combination of propylene glycol and butyric acid. It belongs to the class of glycol esters commonly used in the food industry. The compound is a colorless to pale yellow liquid with a characteristic odor profile that contributes to its utility as a flavoring agent.

Common Uses

Propyleneglycol Dibutyrate is primarily used as a flavoring agent and flavor adjuvant in the food industry. Flavor adjuvants are substances that enhance, modify, or complement the taste characteristics of food products without necessarily providing flavor themselves. PGDB is incorporated into various food formulations where enhanced flavor delivery or taste modulation is desired. The compound's chemical structure allows it to function effectively in different food matrices, though specific commercial applications remain proprietary to individual manufacturers.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with Propyleneglycol Dibutyrate consumption, and no food recalls have been issued related to this additive. This safety profile reflects the compound's apparent lack of acute toxicity in food applications at permitted usage levels.

The safety of propylene glycol derivatives has been established through extensive research on related compounds. Propylene glycol itself is widely recognized as safe by regulatory agencies worldwide. As an ester derivative, PGDB undergoes metabolic processing similar to other food-grade esters. The butyric acid component, when released through esterase activity in the digestive system, represents a naturally occurring short-chain fatty acid found in various foods.

However, it should be noted that PGDB does not hold FDA GRAS (Generally Recognized as Safe) status. This classification does not necessarily indicate a safety concern but rather reflects the regulatory pathway and available safety documentation for this particular compound. Many food additives function legally without GRAS designation through alternative regulatory approvals.

Regulatory Status

Propyleneglycol Dibutyrate is not listed as GRAS by the FDA, meaning it does not have blanket approval for use in all food categories. Instead, it operates under specific regulatory frameworks and permitted usage guidelines established by food safety authorities. Its regulatory status may vary by jurisdiction and food application.

The compound's legal status in different countries depends on local food additive regulations. Manufacturers using PGDB must comply with specific regulations governing its use, concentration limits, and approved food categories in their respective markets. The absence of GRAS status does not prevent its use in appropriately regulated food applications.

Key Studies

While PGDB-specific toxicological studies are limited in published literature, the safety profile of structurally similar propylene glycol esters has been documented. Research on propylene glycol and its derivatives generally demonstrates low toxicity in food applications. The ester bond structure suggests that PGDB would undergo standard ester hydrolysis in the gastrointestinal tract, producing propylene glycol and butyric acidโ€”both recognized food components with established safety profiles.

The absence of FDA adverse event reports and recalls over years of use provides real-world evidence of safety at permitted usage levels. Continued safety monitoring through post-market surveillance remains standard regulatory practice for all food additives.

Frequently Asked Questions

What is Propyleneglycol Dibutyrate?

Propyleneglycol Dibutyrate (PGDB) is a synthetic flavoring compound derived from propylene glycol and butyric acid. It functions as a flavoring agent and adjuvant in food products, enhancing taste profiles in various applications.

Is Propyleneglycol Dibutyrate safe?

Propyleneglycol Dibutyrate 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 Dibutyrate banned in any country?

Propyleneglycol Dibutyrate 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.