Our Verdict: RATING UNKNOWN

Rhodinyl Isobutyrate

CAS138-23-8

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

Rhodinyl Isobutyrate — food additive

Rhodinyl isobutyrate is a synthetic organic compound used as a flavoring agent in the food industry. It functions as a flavor enhancer and adjuvant, contributing to the aromatic profile of various food and beverage products.

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 Rhodinyl Isobutyrate?

Rhodinyl isobutyrate (CAS Number 138-23-8) is a synthetic flavor compound belonging to the class of organic esters. It is composed of a rhodinyl moiety combined with an isobutyrate group, creating a volatile aromatic molecule. This compound is manufactured through chemical synthesis for use exclusively in food flavoring applications. The substance exists as a liquid with characteristic aromatic properties that contribute floral and fruity notes to food formulations.

Common Uses

Rhodinyl isobutyrate is used in the food and beverage industry primarily as a flavoring agent and flavor enhancer. Its applications include:

- Flavored beverages, including non-alcoholic drinks

- Confectionery and candy products

- Baked goods and snack foods

- Dairy products and flavored milk

- Desserts and frozen treats

- Chewing gum and mints

The compound is typically used in very small quantities, measured in parts per million (ppm), which is standard practice for synthetic flavoring agents. Its role is to provide or enhance the sensory perception of specific fruit and floral flavors in finished food products.

Safety Assessment

Rhodinyl isobutyrate has not been formally evaluated by the FDA as a Generally Recognized As Safe (GRAS) substance through the official GRAS notification program. However, the lack of GRAS status does not necessarily indicate safety concerns. Instead, it reflects that the additive may not have undergone the formal GRAS petition process with the FDA.

The FDA maintains no documented adverse events associated with this additive in its adverse event reporting system. Additionally, no product recalls linked to rhodinyl isobutyrate have been recorded by the FDA. These factors suggest that the compound has not demonstrated significant safety issues in actual food use.

As a synthetic flavoring agent, rhodinyl isobutyrate falls under the broader category of flavor compounds that are generally permitted in food at low levels when used in accordance with Good Manufacturing Practices (GMP). The European Food Safety Authority (EFSA) maintains a Flavor Compounds Database that includes assessments of many similar synthetic esters used in food flavoring.

The absence of reported adverse events and recalls over decades of potential food use, combined with its application at extremely low concentrations, suggests a favorable safety profile. However, comprehensive toxicological studies specific to this compound should be considered when evaluating its complete safety dossier.

Regulatory Status

Rhodinyl isobutyrate is not listed as a GRAS substance with the FDA. This means it does not have the simplified approval pathway available through GRAS notification. Instead, its use in food products would need to comply with FDA regulations as an approved food additive or through established use patterns in countries with applicable food safety frameworks.

In the European Union, synthetic flavor compounds are regulated under Regulation (EC) No. 1334/2008 on flavorings. The specific regulatory status of rhodinyl isobutyrate in the EU should be verified through the EFSA Flavor Database and current EU approved flavorings lists, as regulatory designations can vary by jurisdiction.

The lack of regulatory restriction in major food markets, combined with its continued use in food manufacturing without incident, indicates practical acceptance in the food industry where it is employed.

Key Studies

Limited published peer-reviewed literature specifically focuses on rhodinyl isobutyrate toxicology and safety. Most safety data for synthetic flavor esters derives from structural analogs and the broader chemical class of isobutyrate esters used in food flavoring.

Safety assessments of similar synthetic esters generally indicate that these compounds are rapidly metabolized and do not bioaccumulate. The International Organization of the Flavor Industry (IOFI) maintains technical dossiers on approved flavor compounds, including structure-activity relationship assessments.

The absence of reported adverse events in FDA databases across several decades of food use represents an important practical safety indicator, though formal toxicological studies would be necessary for comprehensive risk characterization.

Frequently Asked Questions

What is Rhodinyl Isobutyrate?

Rhodinyl isobutyrate is a synthetic organic compound used as a flavoring agent in the food industry. It functions as a flavor enhancer and adjuvant, contributing to the aromatic profile of various food and beverage products.

Is Rhodinyl Isobutyrate safe?

Rhodinyl 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 Rhodinyl Isobutyrate banned in any country?

Rhodinyl 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.