Our Verdict: RATING UNKNOWN

Geranyl Isobutyrate

CAS2345-26-8

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

Geranyl Isobutyrate — food additive

Geranyl isobutyrate is a synthetic flavoring compound used to impart fruity, floral notes in food and beverage products. It occurs naturally in some fruits and is primarily employed in small quantities as a flavor adjuvant in processed foods.

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 Geranyl Isobutyrate?

Geranyl isobutyrate (CAS Number 2345-26-8) is a synthetic organic compound belonging to the ester class of flavor chemicals. It is composed of geraniol (an acyclic monoterpene alcohol) combined with isobutyric acid. The compound is characterized by a fruity, floral aroma with subtle green notes, making it valuable in the flavor industry. While geranyl isobutyrate can be found in trace amounts in some natural sources, commercial versions are typically synthesized in laboratory settings for use as a food additive.

Common Uses

Geranyl isobutyrate is used primarily as a flavoring agent in processed foods and beverages. Its applications include:

- Beverages: soft drinks, flavored waters, and cordials

- Confectionery: candies, gums, and chocolate products

- Dairy products: yogurts and flavored milk drinks

- Baked goods: cookies, cakes, and pastries

- Savory products: sauces and seasonings where fruity notes are desired

The compound is typically used in very small quantities (parts per million range) to achieve the desired flavor profile without overwhelming other taste components.

Safety Assessment

Geranyl isobutyrate has not been formally approved by the FDA as Generally Recognized as Safe (GRAS), meaning it does not have explicit FDA GRAS designation. However, this status does not indicate the substance is unsafe. Rather, it reflects that formal GRAS notification or petition processes have not been completed for this particular compound in the United States.

According to FDA records, there have been zero adverse events reported and zero recalls associated with geranyl isobutyrate. This absence of reported safety issues suggests the compound has not caused documented harm at typical consumption levels in food applications.

The European Food Safety Authority (EFSA) and the International Organization of the Flavor Industry (IFIS) databases track flavor chemicals used across different regulatory regions. Geranyl isobutyrate is used in flavoring applications in various countries with different regulatory frameworks, each applying their own safety evaluation criteria.

Like many synthetic flavor compounds, geranyl isobutyrate is used in extremely small quantities in finished food products—typically measured in parts per million. At these concentrations, exposure is minimal and considered acceptable by flavor manufacturers and food companies operating under established safety guidelines.

Regulatory Status

In the United States, geranyl isobutyrate operates in a regulatory gray area. Without FDA GRAS status, manufacturers may use it under the Food and Drug Administration's regulations for food additives, provided they follow the specifications in the Code of Federal Regulations (CFR) or have submitted appropriate safety data. The FDA's lack of objection to its use in food indicates regulatory acceptance, even without formal GRAS designation.

International regulatory frameworks vary. In the European Union, flavor substances are evaluated through the EFSA panel on food additives and flavorings. Geranyl isobutyrate is registered in flavor chemical databases used across Europe and other regions.

Manufacturers using geranyl isobutyrate must comply with relevant food labeling regulations, which typically require disclosure of artificial flavors or chemical additives on product labels.

Key Studies

Specific published safety studies exclusively focused on geranyl isobutyrate are limited in public literature. However, safety assessment of flavor compounds generally involves:

- Acute and subchronic toxicity studies in laboratory animals

- Metabolic pathway analysis

- Comparison with structurally similar compounds with established safety data

- Historical use data in flavor applications

The chemical structure of geranyl isobutyrate—composed of geraniol (recognized as safe in flavoring applications) and isobutyric acid (a naturally occurring short-chain fatty acid)—provides some basis for inferring safety based on constituent components. However, comprehensive published studies specifically evaluating this ester in peer-reviewed journals are not readily available in public databases.

Frequently Asked Questions

What is Geranyl Isobutyrate?

Geranyl isobutyrate is a synthetic flavoring compound used to impart fruity, floral notes in food and beverage products. It occurs naturally in some fruits and is primarily employed in small quantities as a flavor adjuvant in processed foods.

Is Geranyl Isobutyrate safe?

Geranyl Isobutyrate 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 Geranyl Isobutyrate banned in any country?

Geranyl Isobutyrate 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.