Our Verdict: SAFE

2-methyl-1,3-dithiolane

CAS5616-51-3

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

2-methyl-1,3-dithiolane — food additive

2-methyl-1,3-dithiolane is a synthetic flavoring compound containing sulfur that imparts savory, meaty, and umami characteristics to food products. It is used in trace amounts by the food industry to enhance flavor profiles in processed foods, seasonings, and savory 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 2-methyl-1,3-dithiolane?

2-methyl-1,3-dithiolane (CAS Number 5616-51-3) is a synthetic organic compound belonging to the dithiolane family of flavor chemicals. Its molecular structure contains a five-membered ring with two sulfur atoms at positions 1 and 3, and a methyl group at position 2. The presence of sulfur atoms in its structure is responsible for its distinctive savory, meaty, and umami flavor characteristics. This compound is colorless to pale yellow and is used exclusively as a flavoring agent in the food industry.

Common Uses

2-methyl-1,3-dithiolane is employed as a flavoring agent or flavoring adjuvant in processed food products. Its primary applications include:

- Savory snack seasonings and flavorings

- Meat and broth flavoring formulations

- Umami-enhancing flavor blends

- Processed food seasoning systems

- Savory condiments and sauce bases

The compound is used in very small quantities—typically in the parts per million (ppm) range—to achieve desired sensory effects without contributing significantly to the overall nutritional profile of foods. Like most synthetic flavoring compounds, 2-methyl-1,3-dithiolane is added to foods to enhance taste appeal and consumer acceptance.

Safety Assessment

The available safety data for 2-methyl-1,3-dithiolane is limited but indicates no documented adverse events or safety concerns at levels of use in food applications. The FDA has recorded zero adverse events associated with this additive and zero product recalls linked to its presence in food.

Due to its use in extremely small quantities and its chemical classification as a flavoring agent, systemic exposure through dietary consumption is expected to be minimal. Like other synthetic dithiolane-based flavor compounds, it undergoes metabolic processing in the body before elimination.

The lack of GRAS (Generally Recognized as Safe) status from the FDA does not necessarily indicate a safety concern; rather, it reflects that this particular compound has not been formally evaluated through the GRAS petition process. Many flavor compounds operate under the Food and Drug Administration's flavor ingredient regulations without requiring explicit GRAS status, provided they comply with applicable regulations and are used at levels consistent with flavoring practice.

Regulatory Status

2-methyl-1,3-dithiolane is not designated as GRAS by the FDA, meaning it has not received formal GRAS affirmation. However, it may be used in foods under FDA's broader regulatory framework for flavor ingredients, which permits use of certain compounds in accordance with 21 CFR Part 182 or under the indirect food additive provisions if it meets established safety standards.

The regulatory status of this compound may vary internationally. Some regulatory agencies have more detailed evaluations of dithiolane-based compounds in their flavor ingredient databases. Manufacturers using this additive are expected to comply with all applicable regulations in their respective markets.

Key Studies

Published scientific literature specific to 2-methyl-1,3-dithiolane is limited, which is typical for minor synthetic flavor compounds used at trace levels. The safety evaluation of such compounds typically relies on:

- Chemical structure-activity relationship (SAR) assessments

- Metabolic fate and toxicology data from related dithiolane compounds

- Long-term industry use history with no associated adverse events

- Compliance with established acceptable daily intake (ADI) levels for flavor compounds

The absence of published adverse event reports or regulatory actions against this ingredient in major food safety databases suggests an acceptable safety profile at current levels of food use. As with all food additives, continued monitoring for emerging safety data remains important.

Frequently Asked Questions

What is 2-methyl-1,3-dithiolane?

2-methyl-1,3-dithiolane is a synthetic flavoring compound containing sulfur that imparts savory, meaty, and umami characteristics to food products. It is used in trace amounts by the food industry to enhance flavor profiles in processed foods, seasonings, and savory applications.

Is 2-methyl-1,3-dithiolane safe?

2-methyl-1,3-dithiolane is currently rated "safe" 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-methyl-1,3-dithiolane banned in any country?

2-methyl-1,3-dithiolane 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.