Our Verdict: RATING UNKNOWN

2-isobutyl-4,5-dimethyloxazole

CAS26131-91-9

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

2-isobutyl-4,5-dimethyloxazole — food additive

2-isobutyl-4,5-dimethyloxazole is a synthetic flavoring compound used to create savory and nutty flavor profiles in processed foods. This oxazole derivative functions as a flavoring agent or adjuvant in various food 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
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-isobutyl-4,5-dimethyloxazole?

2-isobutyl-4,5-dimethyloxazole is a synthetic organic compound classified as a flavoring agent. It belongs to the oxazole family of heterocyclic compounds and is identified by CAS Number 26131-91-9. The compound features an oxazole ring—a five-membered aromatic ring containing nitrogen and oxygen—with specific alkyl substitutions (isobutyl and two methyl groups) that contribute to its sensory properties.

Synthetic flavor compounds like this one are designed to replicate or enhance natural flavors found in foods. The molecular structure determines how the compound interacts with taste and smell receptors, creating specific flavor perceptions.

Common Uses

2-isobutyl-4,5-dimethyloxazole is used in the food industry as a flavoring agent to enhance or create savory, meaty, and roasted notes in processed foods. It may be found in applications including:

- Snack foods and savory seasonings

- Meat analogs and plant-based protein products

- Soups and broths

- Cheese and dairy products

- Ready-to-eat meals

- Condiments and flavor blends

As with most synthetic flavoring compounds, it is typically used in very small quantities—often measured in parts per million—to achieve desired flavor profiles without contributing significantly to caloric or nutritional content.

Safety Assessment

According to FDA records, there have been zero adverse events reported and zero recalls associated with 2-isobutyl-4,5-dimethyloxazole. This absence of reported incidents suggests a safe usage history in the food supply, though it is important to note that lack of reported adverse events does not constitute formal FDA approval.

The compound has not received FDA GRAS (Generally Recognized as Safe) status. GRAS designation would allow for general use without pre-market approval; however, the absence of this designation does not necessarily indicate a safety concern. Instead, it indicates that this particular compound operates under different regulatory pathways or has not undergone the formal GRAS petition and review process with the FDA.

Synthetic flavor compounds undergo different evaluation criteria than food additives used for functional purposes (such as preservatives or colorants). Flavor compounds are typically evaluated based on their organoleptic properties, metabolic pathways, and intended use levels.

Regulatory Status

2-isobutyl-4,5-dimethyloxazole does not appear on the FDA's Color Additives Status List or major regulatory restriction lists. Its regulatory status suggests it may be marketed as a flavoring agent under existing FDA regulations for food flavorings, which permit use of compounds through various compliance pathways.

The European Food Safety Authority (EFSA) maintains its own evaluation systems for flavoring compounds, and regulatory status may differ between regions. Companies seeking to use this compound in different markets should verify compliance with local regulatory requirements.

Key Studies

Limited published peer-reviewed literature specifically addresses 2-isobutyl-4,5-dimethyloxazole in isolation. Most data on this compound exists within proprietary industry assessments and regulatory submission files. Flavor compounds of this type are generally evaluated through in vitro and computational toxicology methods rather than extensive clinical studies, reflecting their minimal exposure levels and established chemical categories.

The oxazole family of compounds has been studied for general structural properties, and structure-activity relationships inform risk assessments for novel members of this chemical class. Regulatory agencies use these existing databases and analytical methods to evaluate new flavoring compounds efficiently.

For any specific safety questions or uses of this compound, consultation with food safety specialists and regulatory experts is recommended.

Frequently Asked Questions

What is 2-isobutyl-4,5-dimethyloxazole?

2-isobutyl-4,5-dimethyloxazole is a synthetic flavoring compound used to create savory and nutty flavor profiles in processed foods. This oxazole derivative functions as a flavoring agent or adjuvant in various food applications.

Is 2-isobutyl-4,5-dimethyloxazole safe?

2-isobutyl-4,5-dimethyloxazole 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 2-isobutyl-4,5-dimethyloxazole banned in any country?

2-isobutyl-4,5-dimethyloxazole 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.