Our Verdict: RATING UNKNOWN

1,2-butanedithiol

CAS16128-68-0

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

1,2-butanedithiol — food additive

1,2-butanedithiol is an organic compound containing two sulfur atoms, used as a flavoring agent and flavor enhancer in food products. It contributes savory, meaty, and sulfur-based aromatic notes to various 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
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 1,2-butanedithiol?

1,2-butanedithiol (CAS Number: 16128-68-0) is a synthetic organic compound belonging to the class of dithiols—molecules containing two thiol (-SH) functional groups. The compound consists of a four-carbon backbone with two sulfur-containing thiol groups attached at the first and second carbon positions. It is a clear, colorless to pale yellow liquid with a characteristic pungent, sulfurous odor. Due to its volatile nature and aromatic properties, it functions primarily as a flavoring agent in the food industry.

Common Uses

1,2-butanedithiol is employed as a flavor enhancer and flavoring agent in processed foods where savory, meaty, or complex sulfur-based notes are desired. It is typically used in very small quantities—measured in parts per million (ppm)—due to its potent aromatic character. Common applications include meat flavoring systems, soup bases, gravy products, and savory snack seasonings. The compound contributes depth and complexity to food flavors, enhancing the perception of umami and cooked meat characteristics. Its use is limited to specialty and processed food applications rather than direct consumption as an ingredient in larger quantities.

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero recalls associated with 1,2-butanedithiol. The compound has not been granted GRAS (Generally Recognized As Safe) status by the FDA, which indicates it has not undergone the formal GRAS notification process. However, the absence of GRAS status does not necessarily indicate safety concerns; rather, it reflects that formal safety evaluation through the GRAS petition pathway has not been completed or submitted.

The compound belongs to a chemical class (dithiols) that has been studied for various applications. Safety considerations for sulfur-containing compounds typically focus on potential allergic reactions in sensitive individuals, though such reactions are generally rare. The high volatility of 1,2-butanedithiol means that most of it dissipates during food processing and cooking, further reducing potential exposure.

Regulatory Status

In the United States, 1,2-butanedithiol is not listed on the FDA's GRAS list, meaning it does not have blanket approval under that regulatory pathway. However, it may be used in foods under the Color Additives and Flavoring provisions if it complies with FDA regulations for indirect food additives or food contact substances, depending on its specific application and concentration. The lack of GRAS status suggests limited widespread commercial use or that manufacturers have not pursued formal FDA notification.

The compound has not been banned or restricted by the FDA. International regulatory bodies, including the European Food Safety Authority (EFSA), have not designated this compound for specific evaluation or approval in most jurisdictions, suggesting limited commercial interest or use in global markets.

Key Studies

Peerreviewed scientific literature specifically addressing 1,2-butanedithiol's safety profile in food applications is limited. Most available data comes from the compound's use in industrial and chemical applications rather than food. General toxicological data on structurally similar dithiols indicates low acute toxicity when ingested in small quantities, though comprehensive chronic toxicity studies specific to this compound in food matrices are not readily available in public literature.

The lack of adverse events or recalls in FDA databases, combined with its use in trace amounts in flavoring applications, suggests that any potential safety risks are minimal under current usage conditions. However, the limited availability of peer-reviewed food safety data means that individuals with specific sensitivities or allergies should exercise caution.

Frequently Asked Questions

What is 1,2-butanedithiol?

1,2-butanedithiol is an organic compound containing two sulfur atoms, used as a flavoring agent and flavor enhancer in food products. It contributes savory, meaty, and sulfur-based aromatic notes to various food formulations.

Is 1,2-butanedithiol safe?

1,2-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 1,2-butanedithiol banned in any country?

1,2-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.