Our Verdict: RATING UNKNOWN

N-butyl 2-methylbutyrate

CAS15706-73-7

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

N-butyl 2-methylbutyrate — food additive

N-butyl 2-methylbutyrate (CAS 15706-73-7) is an ester compound used as a flavoring agent in food products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) ingredient, though it has no recorded adverse events or recalls.

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 N-butyl 2-methylbutyrate?

N-butyl 2-methylbutyrate is a synthetic ester compound belonging to the class of organic chemicals known as carboxylic acid esters. The molecule consists of a butyric acid derivative (2-methylbutyric acid) bonded to a butyl alcohol group. This compound is identified by CAS Number 15706-73-7 and exists as a volatile liquid at room temperature with characteristic fruity and buttery aromatic properties.

Esters of this type are common in the flavor industry due to their ability to impart complex sensory notes to food and beverage products. The specific structural arrangement of N-butyl 2-methylbutyrate contributes to its distinctive flavor profile, which typically includes fruity, apple-like, or buttery notes.

Common Uses

N-butyl 2-methylbutyrate is utilized in the food industry as a flavoring agent or flavoring adjuvant. It may be incorporated into various food products, including:

- Beverages (soft drinks, juices, flavored waters)

- Confectionery items (candy, chocolates)

- Baked goods and pastries

- Dairy products (flavored yogurts, ice cream)

- Savory snacks and processed foods

In these applications, the compound functions to enhance, modify, or create specific flavor profiles. The quantity used is typically very small—measured in parts per million—as esters of this nature are potent flavoring compounds requiring minimal amounts to achieve desired sensory effects.

Safety Assessment

N-butyl 2-methylbutyrate has not been evaluated by the FDA for GRAS (Generally Recognized as Safe) status. This designation does not inherently indicate that the substance is unsafe; rather, it reflects that a formal safety petition has not been submitted to or approved by the FDA through their GRAS notification process.

The FDA's adverse event reporting system shows zero recorded adverse events associated with this compound. Additionally, there have been no product recalls linked to N-butyl 2-methylbutyrate. These data points suggest that if the ingredient is being used in the food supply, it has not generated safety concerns sufficient to trigger regulatory action or consumer complaints.

As an ester compound, N-butyl 2-methylbutyrate is structurally similar to naturally occurring flavor compounds and food components. Many esters of this class have been extensively studied and are approved for use in food in various regulatory jurisdictions. However, the specific toxicological profile of this particular ester would depend on absorption, metabolism, and elimination characteristics in mammalian systems.

Regulatory Status

In the United States, N-butyl 2-methylbutyrate does not have FDA GRAS approval. This means that manufacturers wishing to use it in food products would technically require FDA approval through the food additive petition process, or the ingredient would need to meet specific exemptions for flavoring substances.

The FDA maintains regulations for flavoring agents under 21 CFR Part 182, which includes certain approved flavor compounds. The regulatory pathway for flavoring agents differs from that of other food additives, with some substances qualifying for exemption from premarket approval due to their long history of use or established safety profiles.

The absence of GRAS status should be clarified with regulatory counsel before commercial use. Regulatory requirements may differ in other countries and regions, including the European Union, which maintains its own approved food additive lists.

Key Studies

Limited published scientific literature appears to exist specifically addressing the toxicology or safety of N-butyl 2-methylbutyrate as an isolated compound. The lack of extensive independent research may reflect the compound's relatively niche application in the flavor industry or its recent development.

In the absence of dedicated safety studies, risk assessment for similar ester compounds provides some predictive context. The metabolism of short-chain esters typically occurs through esterase enzymes, leading to hydrolysis into corresponding alcohols and carboxylic acids—processes well-established in human biochemistry.

Further safety data would likely be required to support a GRAS determination or food additive approval petition, should manufacturers pursue regulatory authorization in the United States.

Frequently Asked Questions

What is N-butyl 2-methylbutyrate?

N-butyl 2-methylbutyrate (CAS 15706-73-7) is an ester compound used as a flavoring agent in food products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) ingredient, though it has no recorded adverse events or recalls.

Is N-butyl 2-methylbutyrate safe?

N-butyl 2-methylbutyrate 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 N-butyl 2-methylbutyrate banned in any country?

N-butyl 2-methylbutyrate 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.