Our Verdict: RATING UNKNOWN

Piperonyl Isobutyrate

CAS5461-08-5

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

Piperonyl Isobutyrate — food additive

Piperonyl isobutyrate is an organic compound used as a flavoring agent and flavor enhancer in food products. It is not approved as a Generally Recognized as Safe (GRAS) substance by the FDA and has limited regulatory authorization for food 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 Piperonyl Isobutyrate?

Piperonyl isobutyrate (CAS Number 5461-08-5) is an organic ester compound belonging to the class of synthetic flavoring agents. It is chemically derived from piperonyl alcohol and isobutyric acid. The compound has a molecular structure that gives it characteristic aromatic properties, making it useful in flavoring applications. As a synthetic flavoring agent, it is designed to enhance or impart specific taste and aroma characteristics to food and beverage products.

Common Uses

Piperonyl isobutyrate functions primarily as a flavoring agent and flavor enhancer in the food industry. It is used in small quantities to provide or intensify specific flavor profiles in various food products. The compound may be incorporated into beverages, confectionery, baked goods, and other processed foods where flavor enhancement is desired. Like many synthetic flavoring agents, it is typically used at very low concentrations to achieve the desired sensory effect without significantly altering the nutritional profile of the product.

Safety Assessment

According to FDA records, there have been zero adverse events reported in connection with piperonyl isobutyrate, and no product recalls have been initiated due to this additive. However, it is important to note that this compound does not hold GRAS (Generally Recognized as Safe) status with the FDA, which means it has not undergone the formal safety evaluation process required for unrestricted use in food products.

The lack of reported adverse events and recalls suggests that where it has been used, no significant safety concerns have emerged in real-world consumption. However, the absence of GRAS status indicates that comprehensive toxicological data may be limited or that the FDA has determined that existing evidence does not meet the threshold for general recognition of safety.

The safety profile of synthetic flavoring agents like piperonyl isobutyrate typically depends on factors including the dose, frequency of exposure, and individual sensitivity. Most flavoring agents used in food are employed at concentrations far below levels that would pose acute toxicological concerns.

Regulatory Status

Piperonyl isobutyrate's regulatory status varies by jurisdiction. In the United States, it does not have GRAS approval from the FDA for unrestricted use as a food additive. This means that its use in food products would need to be authorized through specific food additive petitions or other regulatory pathways, or it may be permitted only under certain restricted conditions.

The lack of GRAS status does not necessarily indicate that the substance is unsafe; rather, it reflects the status of the regulatory review process and available safety data. Manufacturers seeking to use this ingredient in food products would need to verify its regulatory standing in their specific jurisdiction and comply with applicable regulations.

Key Studies

Published toxicological and safety data specifically on piperonyl isobutyrate appear limited in the publicly available scientific literature. The compound's use in food applications is relatively restricted compared to other common synthetic flavoring agents with GRAS status.

Safety assessments of synthetic flavoring agents generally rely on standard toxicological testing protocols, which may include acute toxicity studies, repeated-dose studies, and in some cases, specialized testing depending on the chemical structure and intended use level. The absence of reported adverse events and recalls suggests that any exposure through food consumption has not resulted in documented safety incidents.

Frequently Asked Questions

What is Piperonyl Isobutyrate?

Piperonyl isobutyrate is an organic compound used as a flavoring agent and flavor enhancer in food products. It is not approved as a Generally Recognized as Safe (GRAS) substance by the FDA and has limited regulatory authorization for food use.

Is Piperonyl Isobutyrate safe?

Piperonyl 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 Piperonyl Isobutyrate banned in any country?

Piperonyl 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.