Our Verdict: RATING UNKNOWN

Alpha,alpha-dimethylbenzyl Isobutyrate

CAS7774-60-9

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

Alpha,alpha-dimethylbenzyl Isobutyrate — food additive

Alpha,alpha-dimethylbenzyl isobutyrate is a synthetic organic compound used as a flavoring agent in food products. It imparts fruity and floral notes and is employed in small quantities to enhance the sensory profile of beverages, confections, and other 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
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 Alpha,alpha-dimethylbenzyl Isobutyrate?

Alpha,alpha-dimethylbenzyl isobutyrate (CAS Number 7774-60-9) is a synthetic ester belonging to the class of organic compounds used in the food industry as a flavoring agent. It is characterized by a molecular structure consisting of an isobutyrate ester group attached to a dimethylbenzyl moiety. This compound is manufactured through chemical synthesis rather than extracted from natural sources, classifying it as an artificial flavor compound.

Common Uses

This flavoring agent is used in trace amounts in various food and beverage applications, including:

- Soft drinks and carbonated beverages

- Confectionery and candy products

- Baked goods and snack foods

- Dairy-based products

- Frozen desserts

Typical usage levels are in the parts per million (ppm) range, reflecting the concentrated nature of synthetic flavoring compounds. The compound contributes fruity and slightly floral notes to finished products, enhancing overall flavor complexity without imparting unwanted off-flavors.

Safety Assessment

Alpha,alpha-dimethylbenzyl isobutyrate has not been granted GRAS (Generally Recognized As Safe) status by the FDA, indicating that it does not meet the criteria for self-affirmation by manufacturers under the standard GRAS framework. However, this designation does not indicate the presence of safety concerns; rather, it reflects that formal GRAS documentation or FDA approval has not been established through standard regulatory pathways.

According to FDA records, there are no reported adverse events associated with this compound, and no food recalls linked to its presence have been documented. The absence of adverse event reports suggests that if the compound is in use, it has not generated consumer safety complaints or health concerns sufficient to warrant regulatory action.

The compound's structure as an ester is relevant to safety assessment, as many simple esters are well-tolerated by the human digestive system. Esters in this chemical class typically undergo hydrolysis in the gastrointestinal tract, breaking down into their constituent acids and alcohols, which are often endogenous or readily metabolized.

Regulatory Status

In the United States, flavoring agents used in food are subject to FDA oversight under the Food Additives Amendment and the color additives provisions of the Federal Food, Drug, and Cosmetic Act. While alpha,alpha-dimethylbenzyl isobutyrate lacks formal GRAS status, it may be used in food under the "prior sanction" pathway if it was approved before the 1958 Food Additives Amendment, or it may be used pending completion of safety review through a Food Additive Petition.

The European Union maintains separate approval procedures for flavoring agents under Regulation (EC) No 1334/2008. The regulatory acceptance of a flavoring agent varies by jurisdiction based on differing risk assessment standards and historical approval data.

Key Studies

Limited published toxicological data is readily available for this specific compound in scientific literature. Safety assessments for synthetic flavoring agents of this class typically rely on:

- Structure-activity relationship (SAR) analysis

- Acute toxicity studies

- Metabolic fate and disposition studies

- Comparative assessment with chemically similar approved compounds

The Flavor and Extract Manufacturers Association (FEMA) and international flavor industry bodies maintain technical dossiers on approved flavoring agents, though public access to proprietary safety data is limited. Regulatory approval in specific markets typically indicates that safety documentation has been reviewed by relevant authorities.

For consumers, the use of this compound at flavoring levels—typically measured in ppm—places it in a low-exposure category common to synthetic food flavors.

Frequently Asked Questions

What is Alpha,alpha-dimethylbenzyl Isobutyrate?

Alpha,alpha-dimethylbenzyl isobutyrate is a synthetic organic compound used as a flavoring agent in food products. It imparts fruity and floral notes and is employed in small quantities to enhance the sensory profile of beverages, confections, and other processed foods.

Is Alpha,alpha-dimethylbenzyl Isobutyrate safe?

Alpha,alpha-dimethylbenzyl 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 Alpha,alpha-dimethylbenzyl Isobutyrate banned in any country?

Alpha,alpha-dimethylbenzyl 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.