Our Verdict: RATING UNKNOWN

(+/-)-ethyl 3-acetoxy-2-methylbutyrate

CAS139564-43-5

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

(+/-)-ethyl 3-acetoxy-2-methylbutyrate — food additive

(+/-)-ethyl 3-acetoxy-2-methylbutyrate is a synthetic flavoring compound used to create fruity and complex taste profiles in food and beverage products. This ester functions as a flavoring agent or adjuvant in the food industry, contributing aromatic properties to finished products.

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 (+/-)-ethyl 3-acetoxy-2-methylbutyrate?

(+/-)-ethyl 3-acetoxy-2-methylbutyrate, identified by CAS Number 139564-43-5, is a synthetic organic compound belonging to the ester chemical family. It is a colorless to pale yellow liquid with a fruity odor characteristic of complex fruit esters. The compound is produced through chemical synthesis and is used exclusively as a flavoring agent in the food and beverage industry.

Common Uses

This flavoring compound is utilized in various food applications to enhance and create specific taste and aroma profiles. Primary uses include:

- Beverage flavoring, particularly in fruit-flavored drinks and soft drinks

- Confectionery and candy production

- Dairy product flavoring

- Baked goods and snack foods

- Alcoholic beverage enhancement

The compound typically functions at very low concentration levels, measured in parts per million (ppm), which is standard practice for synthetic flavoring agents. Food manufacturers select this additive for its ability to provide fruity, ester-like notes that enhance overall flavor complexity.

Safety Assessment

According to FDA records, there have been zero adverse events reported for (+/-)-ethyl 3-acetoxy-2-methylbutyrate, and zero recalls associated with this additive. This compounds the safety profile based on available data in the FDA Adverse Event Reporting System (FAERS).

As a synthetic flavoring compound, this additive undergoes evaluation based on its chemical structure, intended use levels, and metabolic fate in the body. The ester structure is typical of naturally-occurring and synthetic flavoring compounds that are generally metabolized by standard human enzymatic pathways. Like most synthetic flavoring agents, it is used at levels substantially below those that would pose toxicological concern.

The absence of reported adverse events combined with no recall history suggests that this compound has not raised safety flags in commercial food applications. However, toxicological data from published scientific literature should be reviewed by regulatory agencies to establish comprehensive safety parameters.

Regulatory Status

(+/-)-ethyl 3-acetoxy-2-methylbutyrate is not listed on the FDA's Generally Recognized as Safe (GRAS) list. This means the compound has not been formally affirmed as GRAS through either FDA evaluation or self-determination by manufacturers using the GRAS notification process.

Despite lacking GRAS status in the United States, the compound may be used in food under FDA regulations if it complies with applicable food additive regulations or if it falls within permitted flavoring categories. Different regulatory jurisdictions worldwide may have varying approval statuses for this compound.

Manufacturers using this additive should ensure compliance with FDA Color Additives Status List and relevant food additive petitions or determinations. It is important to verify current regulatory status with the FDA before using this compound in food products, as regulatory determinations may be updated.

Key Studies

While specific published toxicological studies on (+/-)-ethyl 3-acetoxy-2-methylbutyrate appear limited in publicly available scientific literature, the safety assessment of ester-based flavoring compounds generally relies on:

- Structure-activity relationships with known safe ester flavorings

- Standard toxicological testing protocols for synthetic flavoring agents

- Metabolism studies demonstrating rapid ester hydrolysis to known metabolites

- Intended use levels substantially below threshold of toxicological concern (TTC)

Flavoring compounds in this chemical category are typically evaluated using the Flavors and Extract Manufacturers Association (FEMA) GRAS program or equivalent international frameworks. Additional toxicological data may exist in manufacturer submissions to regulatory agencies that are not publicly disclosed.

Frequently Asked Questions

What is (+/-)-ethyl 3-acetoxy-2-methylbutyrate?

(+/-)-ethyl 3-acetoxy-2-methylbutyrate is a synthetic flavoring compound used to create fruity and complex taste profiles in food and beverage products. This ester functions as a flavoring agent or adjuvant in the food industry, contributing aromatic properties to finished products.

Is (+/-)-ethyl 3-acetoxy-2-methylbutyrate safe?

(+/-)-ethyl 3-acetoxy-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 (+/-)-ethyl 3-acetoxy-2-methylbutyrate banned in any country?

(+/-)-ethyl 3-acetoxy-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.