Our Verdict: RATING UNKNOWN

Diisopentyl Thiomalate

CAS68084-03-7

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

Diisopentyl Thiomalate — food additive

Diisopentyl thiomalate is a synthetic flavoring compound used to impart fruity and sulfur-based notes in food products. This sulfur-containing ester functions as a flavoring agent or adjuvant in limited food 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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth 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 Diisopentyl Thiomalate?

Diisopentyl thiomalate (CAS Number: 68084-03-7) is a synthetic organic compound belonging to the class of thiomalate esters. It is composed of two isopentyl groups attached to a thiomalate core structure, making it a sulfur-containing flavoring molecule. This compound is produced through chemical synthesis rather than derived from natural sources, though it may be used to create flavors that mimic natural fruit or vegetable characteristics.

Common Uses

Diisopentyl thiomalate is used in the food and beverage industry as a flavoring agent or flavor adjuvant. Its primary application is in creating complex flavor profiles, particularly in products requiring fruity, meaty, or sulfur-based aromatic notes. Due to its potency as a flavoring compound, it is typically used in very small concentrations—often measured in parts per million (ppm)—making it a minor component in finished food products. Common applications may include processed foods, beverages, and flavor formulations, though its use remains limited compared to more widely-adopted synthetic flavoring agents.

Safety Assessment

According to FDA records, diisopentyl thiomalate has no reported adverse events linked to its consumption, and there have been no food recalls associated with this ingredient. However, it is important to note that this compound has not been granted GRAS (Generally Recognized As Safe) status by the FDA, which means it does not have the same level of regulatory approval as more commonly used food additives.

The absence of GRAS status does not necessarily indicate a safety concern; rather, it reflects that comprehensive safety data packages have not been formally submitted to and accepted by the FDA through the GRAS notification process. This additive may be used under FDA authorization for specific food applications, or its use may be limited to jurisdictions with different regulatory frameworks.

Limited toxicological data exists in the scientific literature regarding this specific compound. When evaluating sulfur-containing flavor compounds, toxicologists typically consider factors such as acute oral toxicity, potential for skin or eye irritation, and metabolic pathways within the body. The chemical structure suggests this compound would be metabolized similarly to other short-chain esters, though specific metabolic studies for this particular molecule may be limited.

Regulatory Status

In the United States, diisopentyl thiomalate does not hold FDA GRAS status. Its regulatory status may vary internationally. The European Union's system for food additives and flavoring agents has different approval mechanisms than the FDA, and this compound may have different regulatory standing in different regions. Food manufacturers using this ingredient in specific jurisdictions should verify compliance with local food safety regulations and any flavor additive authorization lists.

The lack of GRAS status in the U.S. means any food application would need to follow FDA's pre-market approval pathway for food additives or be subject to other regulatory provisions that may permit its use in specific food categories.

Key Studies

Published scientific literature specifically examining diisopentyl thiomalate's safety profile is limited. Most information about this compound derives from chemical databases and manufacturer safety data sheets rather than independent peer-reviewed toxicology studies. The flavoring industry generally undergoes safety evaluation through organizations like the Flavor and Extract Manufacturers Association (FEMA) Expert Panel, though details of specific assessments for minor flavor compounds are not always publicly available.

For manufacturers and regulators seeking comprehensive safety information, consultations with the relevant food safety authority in the intended market of use is recommended, as safety evaluations may have been conducted under confidential industry submissions.

Frequently Asked Questions

What is Diisopentyl Thiomalate?

Diisopentyl thiomalate is a synthetic flavoring compound used to impart fruity and sulfur-based notes in food products. This sulfur-containing ester functions as a flavoring agent or adjuvant in limited food applications.

Is Diisopentyl Thiomalate safe?

Diisopentyl Thiomalate 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 Diisopentyl Thiomalate banned in any country?

Diisopentyl Thiomalate 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.