Our Verdict: SAFE

2-methyl-3-heptanone

CAS13019-20-0

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-methyl-3-heptanone — food additive

2-methyl-3-heptanone is a synthetic organic compound used as a flavoring agent in food products. It contributes fruity and slightly herbaceous flavor notes to 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
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-3-heptanone?

2-methyl-3-heptanone (CAS Number: 13019-20-0) is a synthetic flavoring compound belonging to the ketone family of organic molecules. It is a colorless to pale yellow liquid with a fruity odor characteristic of various fruits and fermented products. The compound is used in minute quantities in food formulations to enhance or create specific flavor profiles.

Common Uses

As a flavoring agent, 2-methyl-3-heptanone is incorporated into a variety of processed foods and beverages where fruity or subtle herbaceous notes are desired. Typical applications include:

- Flavored beverages (soft drinks, juices, and flavored waters)

- Dairy products (yogurts, flavored milk, ice cream)

- Confectionery items (candies, chocolates)

- Baked goods and grain products

- Savory snacks and seasonings

- Alcoholic beverages in some regions

The compound is used at extremely low concentrations—typically parts per million—to achieve the desired sensory effect without dominating the overall flavor profile.

Safety Assessment

The available safety data for 2-methyl-3-heptanone indicates a favorable safety profile based on current evidence. The FDA has recorded zero adverse events associated with this additive and zero recalls involving products containing it. This suggests a history of safe use in food applications.

While 2-methyl-3-heptanone has not received GRAS (Generally Recognized As Safe) designation from the FDA, this does not necessarily indicate a safety concern. Rather, it reflects that formal GRAS notification or affirmative FDA determination has not been pursued or completed for this particular compound. Many flavoring agents operate under the Flavor and Extract Manufacturers' Association (FEMA) GRAS program, which maintains its own list of substances deemed safe for intended use.

Toxicological considerations for synthetic flavoring agents of this type typically focus on acute and subchronic toxicity studies. The molecular structure and metabolic fate of such ketone-based compounds suggest rapid metabolism and excretion when consumed in the trace amounts used in food applications.

Regulatory Status

The regulatory status of 2-methyl-3-heptanone varies internationally. In the United States, it may be used as a flavoring agent under the FDA's regulations governing food additives and flavoring substances, though it lacks formal FDA GRAS status. The European Food Safety Authority (EFSA) maintains separate evaluations for flavoring compounds used in the EU market.

Flavorings used in food products are typically subject to less stringent pre-market approval requirements than other food additives, reflecting the long history of safe use with many naturally-derived and synthetic flavoring compounds at trace concentrations.

As with all food additives, the compound must be used in accordance with Good Manufacturing Practices (GMP), meaning it should be used at the minimum level necessary to achieve the intended effect.

Key Studies

Specific published safety studies exclusively focused on 2-methyl-3-heptanone are limited in the publicly available scientific literature. Safety evaluation of this compound has likely occurred through:

- FEMA GRAS panel assessments if submitted through that pathway

- General toxicology data for structurally similar ketone flavor compounds

- Metabolism studies for related synthetic flavoring agents

- Long-term food use data demonstrating absence of adverse effects

The absence of FDA adverse event reports or recalls provides empirical evidence of safe use over the period during which it has been available in the food supply.

Frequently Asked Questions

What is 2-methyl-3-heptanone?

2-methyl-3-heptanone is a synthetic organic compound used as a flavoring agent in food products. It contributes fruity and slightly herbaceous flavor notes to various processed foods and beverages.

Is 2-methyl-3-heptanone safe?

2-methyl-3-heptanone 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-3-heptanone banned in any country?

2-methyl-3-heptanone 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.