Our Verdict: RATING UNKNOWN

Methyl P-tert-butylphenylacetate

CAS3549-23-3

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

Methyl P-tert-butylphenylacetate — food additive

Methyl P-tert-butylphenylacetate (CAS 3549-23-3) is a synthetic organic compound used as a flavoring agent in food products. It imparts aromatic, herbal, and woody notes to beverages, confectionery, 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 Methyl P-tert-butylphenylacetate?

Methyl P-tert-butylphenylacetate is a synthetic aromatic chemical compound belonging to the class of phenolic esters. It is characterized by a tert-butyl group attached to a phenyl ring with an acetic acid methyl ester substituent. This structural composition gives the compound distinctive organoleptic properties that make it valuable in flavor formulation. The compound is a colorless to pale yellow liquid with a characteristic aromatic odor profile.

Common Uses

Methyl P-tert-butylphenylacetate is primarily used as a flavoring agent and flavor adjuvant in the food and beverage industry. It appears in formulations for soft drinks, alcoholic beverages, confectionery products, baked goods, and savory snacks. The compound contributes herbal, woody, and slightly spicy notes that complement both sweet and savory applications. Flavor chemists utilize this additive in combination with other aromatic compounds to create complex flavor profiles. Typical usage levels are low, generally in the parts per million (ppm) range, as is standard for synthetic flavoring agents.

Safety Assessment

Methyl P-tert-butylphenylacetate has not been formally approved by the FDA as a Generally Recognized as Safe (GRAS) substance through the agency's official petition process. However, the compound has a favorable safety profile based on available data. The FDA Adverse Events Reporting System (FAERS) contains zero reported adverse events associated with this additive, and no product recalls have been attributed to its use. This absence of reported safety incidents in the post-market surveillance system suggests no significant safety concerns have emerged during its use as a minor ingredient in food products.

The compound's safety profile is supported by its chemical structure and mechanism of action. As a synthetic flavor compound used at very low concentrations, exposure levels are minimal. The tert-butyl phenyl structure is chemically stable under normal food storage and processing conditions. No published scientific literature documents significant toxicological concerns specific to this compound, though comprehensive toxicological studies may be limited in the public domain.

The European Commission has established a flavoring substance database (FLAVIS) that catalogs approved flavoring agents under EU Regulation (EC) No 1334/2008. Regulatory frameworks in major markets reflect the understanding that synthetic flavoring agents present minimal risk when used at appropriate concentrations as determined by flavor industry practices.

Regulatory Status

Methyl P-tert-butylphenylacetate is not listed on the FDA's GRAS list, meaning it has not undergone formal GRAS determination through published regulatory petitions. However, this designation does not indicate safety concerns; rather, it reflects that formal petitions may not have been submitted or that the additive falls under general flavoring agent provisions. In the United States, synthetic flavoring agents are regulated under 21 CFR Part 182, and manufacturers are responsible for ensuring their safety at intended use levels.

The compound is permissible for use in flavoring formulations under the broader category of synthetic flavoring substances where manufacturers have conducted appropriate safety assessments. International regulatory acceptance varies; some jurisdictions include the compound in their approved flavoring substance lists while others have not specifically enumerated it.

Key Studies

Limited peer-reviewed literature specifically addresses methyl P-tert-butylphenylacetate. Most safety information derives from structural analogs and general toxicological principles applicable to synthetic aromatic esters. The flavor industry's safety assessment system, managed through organizations like the International Organization of the Flavor Industry (IOFI) and the Flavor and Extract Manufacturers Association (FEMA), evaluates structurally similar compounds to inform safety conclusions. No studies documenting adverse health effects in human populations have been published. The compound's use history as a minor flavoring ingredient, combined with the absence of adverse event reports, provides practical evidence of an acceptable safety margin under normal use conditions.

Frequently Asked Questions

What is Methyl P-tert-butylphenylacetate?

Methyl P-tert-butylphenylacetate (CAS 3549-23-3) is a synthetic organic compound used as a flavoring agent in food products. It imparts aromatic, herbal, and woody notes to beverages, confectionery, and other processed foods.

Is Methyl P-tert-butylphenylacetate safe?

Methyl P-tert-butylphenylacetate 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 Methyl P-tert-butylphenylacetate banned in any country?

Methyl P-tert-butylphenylacetate 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.