Our Verdict: RATING UNKNOWN

2,3-butanedithiol

CAS4532-64-3

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

2,3-butanedithiol — food additive

2,3-butanedithiol is an organic compound containing sulfur that functions as a flavoring agent and flavor enhancer in food products. It is used in very small quantities to impart savory, meaty, and roasted notes to processed foods.

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 2,3-butanedithiol?

2,3-butanedithiol (CAS Number 4532-64-3) is a volatile organic compound belonging to the dithiol chemical family. It contains two sulfhydryl (-SH) groups attached to a four-carbon backbone, which gives it its characteristic sulfurous chemical properties. The compound exists as a colorless to pale yellow liquid with a strong, pungent odor typical of sulfur-containing flavor compounds. Due to its molecular structure, it readily volatilizes, releasing aromatic compounds when heated or dissolved in food products.

Common Uses

2,3-butanedithiol is employed in the food industry as a flavoring agent and flavor enhancer, primarily in savory applications. It contributes roasted, meaty, and cooked notes to processed foods, making it valuable in products such as meat analogs, instant broths, gravy mixes, soups, and other savory food formulations. The compound is used at extremely low concentrations—typically in the parts per million (ppm) range—to achieve desired sensory profiles without creating an overpowering sulfurous taste. Like many dithiol compounds, it is particularly effective in enhancing umami and savory flavor perceptions.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 2,3-butanedithiol, and no product recalls have been issued related to this additive. The absence of adverse event reports and recalls suggests that when used in typical food applications at appropriate concentrations, the compound has not been associated with health concerns in the United States regulatory system.

However, it is important to note that 2,3-butanedithiol has not received Generally Recognized As Safe (GRAS) status from the FDA. This designation indicates that the compound has not undergone the formal FDA review process that would classify it as safe for general use in food products. This lack of GRAS status means its use in the United States is more restricted compared to GRAS-approved additives. The absence of GRAS status does not necessarily indicate a safety concern but rather reflects the regulatory pathway and amount of toxicological data available.

Like all dithiol compounds, 2,3-butanedithiol is likely metabolized relatively quickly in the body due to its volatile nature and the body's ability to process small organic sulfur compounds. The extremely low concentrations used in food applications further minimize potential exposure.

Regulatory Status

2,3-butanedithiol's regulatory status varies by jurisdiction. In the United States, while not GRAS-approved, it may be permitted for use under specific conditions or in particular food categories, depending on the regulatory framework in place. Manufacturers using this additive must comply with FDA regulations governing flavor additives and generally must notify the FDA of their use through the Flavor and Extract Manufacturers' Association (FEMA) GRAS program or maintain appropriate regulatory documentation.

In the European Union, this compound may be evaluated under different regulatory criteria, and its approval status may differ from that in the United States. International trade of foods containing this additive requires compliance with the importing country's regulations.

Key Studies

Scientific literature on 2,3-butanedithiol specifically is limited in the public domain. Most available information comes from flavor chemistry research and internal industry safety assessments. The compound's chemical properties and behavior are well-understood through general organic chemistry principles. Additional toxicological studies may exist in proprietary industry databases or have been submitted to regulatory agencies as part of confidential business information. The lack of published adverse event data and recall history provides practical evidence of safe use at food-grade concentrations, though comprehensive peer-reviewed safety studies would strengthen the evidence base.

Frequently Asked Questions

What is 2,3-butanedithiol?

2,3-butanedithiol is an organic compound containing sulfur that functions as a flavoring agent and flavor enhancer in food products. It is used in very small quantities to impart savory, meaty, and roasted notes to processed foods.

Is 2,3-butanedithiol safe?

2,3-butanedithiol 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 2,3-butanedithiol banned in any country?

2,3-butanedithiol 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.