Our Verdict: SAFE

2,3-diethyl-5-methylpyrazine

CAS18138-04-0

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-diethyl-5-methylpyrazine — food additive

2,3-diethyl-5-methylpyrazine is a synthetic flavoring agent widely used in the food industry to impart roasted, nutty, coffee, and chocolate-like notes. It is a pyrazine derivative, a class of compounds known for their potent aromatic contributions to cooked foods. While not formally listed as FDA GRAS, it has been designated as Generally Recognized as Safe (GRAS) by the Flavor and Extract Manufacturers Association (FEMA No. 3274) and approved by the European Food Safety Authority (EFSA) for use as a flavoring.

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-diethyl-5-methylpyrazine?

2,3-diethyl-5-methylpyrazine is a synthetic organic compound categorized as a pyrazine derivative, primarily utilized as a flavoring agent in the food industry. Pyrazines are a class of heterocyclic organic compounds distinguished by a six-membered ring containing two nitrogen atoms at opposite positions. These compounds are renowned for their potent aroma contributions, especially in roasted, toasted, nutty, and savory food products. 2,3-diethyl-5-methylpyrazine specifically imparts roasted, nutty, coffee, and chocolate-like notes, with potential nuances of caramel or slight potato-like undertones, depending on its concentration and the food matrix in which it is used. Although pyrazine compounds occur naturally during heating and cooking processes—contributing to the characteristic aromas and tastes of roasted coffee, baked bread, or grilled meats—2,3-diethyl-5-methylpyrazine is typically synthesized for commercial food applications. Its molecular formula is C9H14N2.

Common Uses

As a flavoring agent, 2,3-diethyl-5-methylpyrazine is incorporated into a diverse array of processed foods to enhance or replicate desirable flavor profiles. Due to its high potency, it is used at very low concentrations. Typical applications include:

* **Baked Goods and Confectionery:** It is used to impart nutty, roasted, or chocolate notes in products such as cookies, crackers, bread, and various candies.

* **Snack Foods:** Employed in products like potato chips, corn snacks, and crackers to create or amplify savory, roasted, or grilled flavors.

* **Beverages:** Found in some coffee, chocolate, or nut-flavored drinks.

* **Meat and Savory Products:** Utilized in simulated meat flavors, gravies, sauces, and ready meals to contribute to roasted, meaty, or umami characteristics.

* **Dairy Products:** Can be incorporated into certain cheese or butter flavorings to enrich their profiles.

* **Flavor Blends:** It frequently serves as a component within complex flavor formulations, adding depth and specific aromatic nuances to overall taste experiences.

Its strategic inclusion helps food manufacturers achieve consistent and appealing sensory attributes often associated with traditional cooking methods, enhancing consumer enjoyment of processed foods.

Safety Assessment

The safety of 2,3-diethyl-5-methylpyrazine as a food additive has been rigorously reviewed by leading expert scientific bodies worldwide. Its classification as a flavoring substance is central to these assessments.

The Flavor and Extract Manufacturers Association (FEMA) Expert Panel, a prominent scientific authority on flavoring safety in the United States, has thoroughly evaluated 2,3-diethyl-5-methylpyrazine. Based on a comprehensive review of available scientific and toxicological data, alongside a history of safe use, the panel designated it as Generally Recognized as Safe (GRAS) under FEMA GRAS number 3274. This designation indicates that the substance presents no safety concerns at current anticipated levels of intake.

In Europe, the European Food Safety Authority (EFSA) Panel on Food Additives and Flavourings (FAF) has also assessed 2,3-diethyl-5-methylpyrazine. It was included in Flavouring Group Evaluation 75, Revision 3 (FGE.75Rev3). In their scientific opinion, EFSA concluded that there is "no safety concern for the flavouring substances evaluated" in FGE.75, which encompasses 2,3-diethyl-5-methylpyrazine, at their current use levels as flavouring agents. This evaluation takes into account potential genotoxicity, carcinogenicity, reproductive toxicity, and other adverse effects, finding no evidence of concern within the context of dietary exposure.

Furthermore, the U.S. Food and Drug Administration's (FDA) databases show no reported adverse events or recalls specifically linked to 2,3-diethyl-5-methylpyrazine. This lack of documented acute or chronic health issues from its consumption as a flavoring agent reinforces the findings of expert panels. The typical use levels in food are extremely low, reflecting its high flavor potency, which further minimizes the potential for systemic exposure and toxicity.

Regulatory Status

The regulatory status of 2,3-diethyl-5-methylpyrazine confirms its widespread acceptance as a safe flavoring agent across major global food markets.

* **United States:** While 2,3-diethyl-5-methylpyrazine is not formally listed as "FDA GRAS" in the Code of Federal Regulations (21 CFR Parts 182, 184, 186) through a formal FDA affirmation, it is considered GRAS by the Flavor and Extract Manufacturers Association (FEMA) Expert Panel (FEMA GRAS No. 3274). The FDA generally accepts the determinations of the FEMA Expert Panel for flavoring substances. This allows their use in food under conditions that are generally recognized as safe by qualified experts. Flavoring ingredients are frequently incorporated into food formulations based on such expert GRAS determinations, often without direct pre-market approval by the FDA, provided the use aligns with the established GRAS conditions.

* **European Union:** In the EU, 2,3-diethyl-5-methylpyrazine is authorized for use as a flavoring substance in accordance with Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties. Its inclusion in FGE.75Rev3 by EFSA confirms its approval for use, subject to maximum use levels outlined in the regulation or according to Good Manufacturing Practice (GMP) principles where no specific limits are set.

* **Other International Bodies:** The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also evaluates flavoring agents, often grouping them by chemical structure. While specific JECFA evaluations for this compound might be part of a larger group, the global consensus among regulatory authorities aligns with its safe use as a flavoring agent at typical dietary exposure levels.

Compliance with national and international food additive regulations ensures that 2,3-diethyl-5-methylpyrazine can be safely used in food products within established parameters.

Key Studies

The safety profile of 2,3-diethyl-5-methylpyrazine is primarily supported by comprehensive evaluations conducted by recognized expert scientific committees:

* **FEMA GRAS Assessments:** The Flavor and Extract Manufacturers Association (FEMA) Expert Panel has conducted extensive reviews of 2,3-diethyl-5-methylpyrazine, culminating in its designation as FEMA GRAS (No. 3274). These assessments consider toxicity data, metabolic pathways, and estimated dietary exposures to ensure safety. The panel's evaluations are published in peer-reviewed journals, providing the scientific basis for its GRAS status and general acceptance within the industry.

* **EFSA Flavouring Group Evaluation (FGE.75, Revision 3):** The European Food Safety Authority's Panel on Food Additives and Flavourings (FAF) concluded its safety review for 2,3-diethyl-5-methylpyrazine as part of FGE.75, Revision 3. This evaluation, published as a scientific opinion, grouped structurally related pyrazine compounds for a collective risk assessment. The panel applied the Threshold of Toxicological Concern (TTC) approach where appropriate, alongside available toxicological studies, to determine that there are no safety concerns at current use levels. This comprehensive assessment included consideration of absorption, metabolism, distribution, excretion, acute and subchronic toxicity, genotoxicity, and carcinogenicity.

* **General Pyrazine Toxicity Studies:** While specific chronic studies focused solely on 2,3-diethyl-5-methylpyrazine may be limited due to its low exposure levels, the safety of pyrazines as a chemical class is well-established. Studies on various pyrazine derivatives often demonstrate low oral toxicity and rapid metabolism and excretion in mammals, contributing to the broader understanding of the general safety of this chemical class. These group evaluations by bodies like JECFA and EFSA leverage this comprehensive understanding of chemical analogs to assess the safety of individual pyrazine compounds.

Frequently Asked Questions

What is 2,3-diethyl-5-methylpyrazine?

2,3-diethyl-5-methylpyrazine is a synthetic flavoring agent widely used in the food industry to impart roasted, nutty, coffee, and chocolate-like notes. It is a pyrazine derivative, a class of compounds known for their potent aromatic contributions to cooked foods. While not formally listed as FDA GRAS, it has been designated as Generally Recognized as Safe (GRAS) by the Flavor and Extract Manufacturers Association (FEMA No. 3274) and approved by the European Food Safety Authority (EFSA) for use as a flavoring.

Is 2,3-diethyl-5-methylpyrazine safe?

2,3-diethyl-5-methylpyrazine 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-diethyl-5-methylpyrazine banned in any country?

2,3-diethyl-5-methylpyrazine 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.