Our Verdict: RATING UNKNOWN

Isobornyl 2-methylbutyrate

CAS94200-10-9

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

Isobornyl 2-methylbutyrate — food additive

Isobornyl 2-methylbutyrate is a synthetic flavoring compound used to impart fruity and woody notes in food products. It is not approved as a food additive by the FDA but may be used in some jurisdictions under different regulatory frameworks.

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 Isobornyl 2-methylbutyrate?

Isobornyl 2-methylbutyrate (CAS Number: 94200-10-9) is a synthetic organic compound belonging to the ester class of flavoring molecules. The compound consists of an isobornyl alcohol moiety esterified with 2-methylbutyric acid. It is a colorless to pale yellow liquid with characteristic fruity and woody aromatic properties. Like many synthetic esters used in the flavor industry, it functions by providing specific sensory notes to food formulations.

Common Uses

This flavoring agent is primarily used in the beverage industry, particularly in alcoholic drinks such as spirits and liqueurs where complex flavor profiles are desired. It may also find applications in confectionery, baked goods, and other processed foods where fruit and wood notes enhance consumer appeal. The compound's fruity character makes it valuable for formulating natural-matching flavors, though the additive itself is synthetically produced. Usage levels in food applications are typically very low, measured in parts per million (ppm), as flavoring agents require only minimal quantities to achieve desired sensory effects.

Safety Assessment

Isobornyl 2-methylbutyrate has not been formally evaluated for safety by the FDA and does not hold GRAS (Generally Recognized As Safe) status in the United States. However, the absence of FDA approval does not necessarily indicate safety concerns. The compound shares structural similarities with other approved flavoring esters and natural compounds like bornyl acetate, which has an established history of safe use in foods.

According to FDA records, there have been zero adverse events reported associated with this additive and zero recalls involving isobornyl 2-methylbutyrate. This suggests either minimal exposure in the U.S. food supply or an absence of documented safety issues in jurisdictions where it is permitted.

The toxicological profile of this compound would be consistent with other ester-based flavorings, which generally exhibit low acute toxicity when ingested at typical usage levels. The isobornyl group, derived from camphor, has historical use in traditional applications, and 2-methylbutyric acid is a short-chain fatty acid naturally present in foods.

Regulatory Status

In the United States, isobornyl 2-methylbutyrate is not approved by the FDA as a food additive and does not appear on the GRAS list. This means manufacturers cannot legally add it directly to foods marketed in the U.S., though it may be permitted in imported foods or used in fragrances and cosmetics under different regulatory categories.

Regulatory approval varies internationally. Some European and Asian markets may permit this flavoring under their respective regulatory frameworks, where it may be assessed under different safety evaluation standards. The European Food Safety Authority (EFSA) has not conducted a specific published assessment of this particular compound.

Flavorings in the U.S. are subject to FDA regulations under 21 CFR Part 182 for natural and synthetic flavoring substances. Manufacturers wishing to use isobornyl 2-methylbutyrate would need to either obtain GRAS status through a proper safety petition or ensure it is legally imported as a component of processed foods from approved suppliers.

Key Studies

Limited published scientific literature specifically addresses isobornyl 2-methylbutyrate in isolation. Safety evaluations of structurally similar compounds, such as bornyl esters and 2-methylbutyrate esters, provide relevant data for understanding its potential safety profile. The International Fragrance Association (IFRA) and the Research Institute for Fragrance Materials (RIFM) maintain databases of safety information for flavor and fragrance compounds, though specific peer-reviewed toxicology studies on this particular molecule are not readily available in public scientific literature.

The lack of documented adverse events and recalls suggests acceptable safety margins in food applications where the additive has been used, though formal toxicological studies would be necessary to establish definitive safety parameters for regulatory approval in jurisdictions like the United States.

Frequently Asked Questions

What is Isobornyl 2-methylbutyrate?

Isobornyl 2-methylbutyrate is a synthetic flavoring compound used to impart fruity and woody notes in food products. It is not approved as a food additive by the FDA but may be used in some jurisdictions under different regulatory frameworks.

Is Isobornyl 2-methylbutyrate safe?

Isobornyl 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 Isobornyl 2-methylbutyrate banned in any country?

Isobornyl 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.