Our Verdict: RATING UNKNOWN

Isobutyl Formate

CAS542-55-2

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

Isobutyl Formate โ€” food additive

Isobutyl formate is an organic ester compound used as a flavoring agent in food products. It imparts fruity and ester-like sensory notes and is employed in small quantities to enhance the taste profile of various food and beverage applications.

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
ApprovedHealth 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 Isobutyl Formate?

Isobutyl formate (CAS Number: 542-55-2) is a volatile organic compound belonging to the formate ester family. Chemically, it consists of formic acid esterified with isobutanol. This colorless liquid has a characteristic fruity, slightly sweet odor commonly described as apple-like or pineapple-like. The compound is naturally occurring in trace amounts in some fruits and fermented products, though the food-grade versions used in commercial applications are typically synthetically manufactured.

Common Uses

Isobutyl formate functions primarily as a flavoring agent in the food and beverage industry. It is used in small concentrations to create or enhance fruity flavor profiles in products such as confectionery, baked goods, beverages, dairy products, and other processed foods. As a volatile compound, it contributes quickly to the perceived flavor profile but dissipates rapidly due to its low boiling point, making it useful for immediate sensory impact in food applications. The formate esters are valued in flavor chemistry for their ability to provide authentic fruit-like characteristics that consumers associate with natural flavors.

Safety Assessment

Isobutyl formate has not been designated as Generally Recognized As Safe (GRAS) by the FDA, which means it has not undergone the formal GRAS notification process for use in U.S. food applications. However, the absence of a GRAS designation does not indicate safety concernsโ€”rather, it reflects that formal petition or notification procedures have not been completed for U.S. regulatory approval.

From available data, isobutyl formate shows a favorable safety profile. The FDA database reports zero adverse events associated with this additive, and there have been no recalls linked to its presence in foods. This suggests that if present in the food supply, it has not been connected to documented consumer harm or safety incidents requiring regulatory action.

The compound is volatile and would undergo degradation through normal cooking processes and digestive processes. Its ester structure is subject to hydrolysis in the acidic environment of the stomach, breaking down into formic acid and isobutanol, both of which are metabolized through standard biochemical pathways. Exposure levels from food flavoring applications would be minimal given the small quantities required for sensory effect.

Regulatory Status

The regulatory landscape for isobutyl formate varies by jurisdiction. While it lacks FDA GRAS status in the United States, it may be approved under different regulatory frameworks in other countries. The European Food Safety Authority (EFSA) and other international regulatory bodies maintain separate assessments of flavoring compounds. In regions with established flavor regulations, approved formate esters may appear on positive lists of permitted flavoring substances.

Manufacturers wishing to use isobutyl formate in U.S. food products would need to work through appropriate regulatory channels, which might include submitting a GRAS notice to the FDA or obtaining approval under Food Additive Petition procedures. The lack of widespread FDA approval likely explains its limited use in major U.S. food products, though it may be found in some imported or specialized food items.

Key Studies

Specific published research exclusively focused on isobutyl formate safety remains limited in the publicly available literature. However, the broader formate ester family has been assessed as part of flavor safety evaluations. General toxicology data for structurally similar formate esters and isobutanol (a metabolic product) provides supporting information for safety assessments. The volatile nature of the compound and low use levels suggest minimal bioaccumulation or systemic exposure concerns. Absence of adverse event reports despite its presence in various food systems suggests acceptable safety margins in current applications, though comprehensive modern safety testing would provide additional assurance.

Frequently Asked Questions

What is Isobutyl Formate?

Isobutyl formate is an organic ester compound used as a flavoring agent in food products. It imparts fruity and ester-like sensory notes and is employed in small quantities to enhance the taste profile of various food and beverage applications.

Is Isobutyl Formate safe?

Isobutyl Formate 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 Isobutyl Formate banned in any country?

Isobutyl Formate 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.