Our Verdict: RATING UNKNOWN

Prenyl Isobutyrate

CAS76649-23-5

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

Prenyl Isobutyrate — food additive

Prenyl isobutyrate is a synthetic flavoring compound used to create fruity and tropical taste profiles in food products. It is not approved as a GRAS (Generally Recognized as Safe) substance by the FDA but has no reported adverse events or recalls associated with its use.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 Prenyl Isobutyrate?

Prenyl isobutyrate (CAS Number: 76649-23-5) is a synthetic organic compound belonging to the ester class of flavoring agents. It is chemically composed of a prenyl group attached to an isobutyrate moiety. As a flavoring ingredient, prenyl isobutyrate is designed to impart fruity and tropical flavor notes to food and beverage products. It exists as a liquid at room temperature and is utilized in very small quantities in food formulations.

Common Uses

Prenyl isobutyrate is employed as a flavoring agent in various food and beverage applications. It is typically used in products where fruity or tropical taste profiles are desired, such as confectionery, beverages, dairy products, and baked goods. Like most synthetic flavoring compounds, prenyl isobutyrate is used in minimal concentrations—typically measured in parts per million (ppm)—to achieve the desired flavor effect without contributing significantly to the nutritional profile of the final product.

The compound is part of a broader category of synthetic esters that food manufacturers use to create complex flavor systems that would be difficult or economically impractical to achieve using only natural ingredients.

Safety Assessment

Prenyl isobutyrate has not been formally evaluated by the FDA under the GRAS (Generally Recognized as Safe) program, meaning it does not have that specific regulatory designation in the United States. However, this does not necessarily indicate a safety concern; rather, it reflects that the compound may not have undergone the formal GRAS notification process or may be used in restricted capacities.

The FDA maintains no recorded adverse events associated with prenyl isobutyrate consumption, and there have been no product recalls linked to this ingredient. The absence of reported adverse events in the FDA database suggests that any exposure to this flavoring agent through food consumption has not resulted in documented health complaints or safety incidents.

As with most synthetic flavor compounds used in food, prenyl isobutyrate is subject to the principle of threshold of toxicological concern (TTC), which assumes that flavoring agents used at very low levels pose minimal risk to consumer health. The extremely small quantities used in food products—typically less than 1 ppm in finished foods—further contribute to a low exposure profile.

Regulatory Status

In the United States, prenyl isobutyrate does not hold GRAS status with the FDA. This means that while it may be used in food products, it operates under different regulatory pathways than GRAS-approved ingredients. Manufacturers using this ingredient must ensure compliance with applicable FDA regulations regarding food additives and labeling requirements.

The regulatory status may vary in other jurisdictions. The European Food Safety Authority (EFSA) and other regional regulatory bodies may have different approval statuses for this compound. Importers and manufacturers should verify the regulatory approval status in their specific markets before using prenyl isobutyrate in commercial products.

Key Studies

Limited published literature is available specifically on prenyl isobutyrate compared to more widely used flavoring compounds. The lack of extensive published safety studies may reflect the ingredient's relatively niche application in the flavoring industry rather than specific safety concerns.

Safety evaluation of similar ester-based flavor compounds suggests that this class of chemicals is generally well-metabolized by the body and does not bioaccumulate. The structural similarity of prenyl isobutyrate to other approved flavor esters suggests comparable metabolic pathways, though direct toxicological studies on this specific compound would provide additional assurance.

Manufacturers and regulatory bodies rely on the conservative use levels, the chemical structure's relationship to other approved compounds, and the absence of adverse event reports when assessing the safety profile of prenyl isobutyrate.

Frequently Asked Questions

What is Prenyl Isobutyrate?

Prenyl isobutyrate is a synthetic flavoring compound used to create fruity and tropical taste profiles in food products. It is not approved as a GRAS (Generally Recognized as Safe) substance by the FDA but has no reported adverse events or recalls associated with its use.

Is Prenyl Isobutyrate safe?

Prenyl 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 Prenyl Isobutyrate banned in any country?

Prenyl 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.