Our Verdict: SAFE

2,3,5,6-tetramethylpyrazine

CAS1124-11-4

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

2,3,5,6-tetramethylpyrazine — food additive

2,3,5,6-tetramethylpyrazine is an organic compound used as a flavoring agent in food products to provide nutty, roasted, and savory taste notes. It occurs naturally in some foods and is synthetically produced for use in various processed foods and beverages.

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 2,3,5,6-tetramethylpyrazine?

2,3,5,6-tetramethylpyrazine (CAS Number: 1124-11-4) is a heterocyclic organic compound belonging to the pyrazine family. It is a small molecule with a distinctive molecular structure that contributes characteristic flavoring properties. This compound occurs naturally in roasted foods, including coffee, cocoa, nuts, and grains, where it develops during thermal processing. The synthetic version is manufactured for commercial use in the food and beverage industry.

Common Uses

2,3,5,6-tetramethylpyrazine is primarily used as a flavoring agent or flavor adjuvant in food products. Its sensory profile includes nutty, roasted, toasted, and savory notes, making it valuable in applications such as:

- Savory snack foods and seasonings

- Coffee and cocoa products

- Processed meat flavoring systems

- Baked goods and grain-based products

- Beverages and beverage flavorings

- Dairy products and cheese flavors

The compound is used in very small concentrations, typically measured in parts per million (ppm), which is characteristic of flavoring agents. Its natural occurrence in roasted foods supports its application in creating authentic roasted flavor profiles in processed foods.

Safety Assessment

Available safety data for 2,3,5,6-tetramethylpyrazine indicates no significant adverse events reported to the FDA. The FDA database contains zero recorded adverse events and zero recalls associated with this additive. The compound's natural presence in commonly consumed roasted foods such as coffee and nuts provides additional context for its safety profile.

Toxicological studies on pyrazine compounds generally indicate low acute toxicity. The use of this compound at flavoring levels—typically parts per million in finished products—represents extremely low dietary exposure. Most flavoring agents, including pyrazines, are metabolized and eliminated from the body relatively rapidly.

No major genotoxicity or carcinogenicity concerns have been documented in available scientific literature for this specific compound at food-use levels. However, comprehensive long-term safety data specific to this compound may be limited in the public domain.

Regulatory Status

2,3,5,6-tetramethylpyrazine is not on the FDA's GRAS (Generally Recognized as Safe) list. However, this does not indicate the substance is unsafe; rather, it means it has not undergone the formal GRAS determination process through the FDA. Many flavoring agents function under the Flavor and Extract Manufacturers' Association (FEMA) GRAS program, an alternative pathway for flavoring agent safety determination.

The compound may be permitted in food products under FDA regulations for flavoring agents (21 CFR §182.60), provided manufacturers comply with all applicable regulations and use it at appropriate levels for intended flavoring function.

Regulatory status varies internationally. Some regulatory bodies in Europe and other regions may have established acceptable use levels or conducted independent safety assessments. Manufacturers exporting products containing this additive must comply with regulations in their target markets.

Key Studies

Limited peer-reviewed data specific to 2,3,5,6-tetramethylpyrazine toxicity is readily available in public databases. Most safety information derives from general pyrazine toxicology studies and the compound's natural occurrence in food.

Studies on structurally similar pyrazine compounds indicate these molecules are not typically associated with significant toxicological effects at food-relevant exposure levels. The compound's metabolism follows typical pathways for small organic flavor molecules.

The natural presence of 2,3,5,6-tetramethylpyrazine in roasted coffee, nuts, and other foods consumed globally for centuries provides real-world safety history supporting its use as a flavoring agent.

Frequently Asked Questions

What is 2,3,5,6-tetramethylpyrazine?

2,3,5,6-tetramethylpyrazine is an organic compound used as a flavoring agent in food products to provide nutty, roasted, and savory taste notes. It occurs naturally in some foods and is synthetically produced for use in various processed foods and beverages.

Is 2,3,5,6-tetramethylpyrazine safe?

2,3,5,6-tetramethylpyrazine 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 2,3,5,6-tetramethylpyrazine banned in any country?

2,3,5,6-tetramethylpyrazine 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.