Our Verdict: RATING UNKNOWN

2-methyl-4-phenyl-2-butanol

CAS103-05-9

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

2-methyl-4-phenyl-2-butanol — food additive

2-methyl-4-phenyl-2-butanol is a synthetic flavoring compound used to impart fruity and floral notes in food and beverage products. It functions as a flavoring agent or adjuvant in the food industry, though it does not currently hold FDA GRAS (Generally Recognized as Safe) status.

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 2-methyl-4-phenyl-2-butanol?

2-methyl-4-phenyl-2-butanol (CAS Number 103-05-9) is a synthetic organic compound belonging to the class of secondary alcohols used in flavor formulation. It is characterized by a four-carbon backbone with a methyl substituent at the second position and a phenyl group at the fourth position. This structural composition contributes to its sensory properties in food applications.

Common Uses

This flavoring agent is employed in the food and beverage industry to create complex flavor profiles. It is typically used in trace amounts as a component of flavor formulations intended to impart fruity and floral characteristics to products such as beverages, confectionery, baked goods, and dairy products. The compound functions as part of multi-ingredient flavor systems rather than as a standalone additive. Its use concentration varies depending on the food application and desired flavor intensity.

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero recalls associated with 2-methyl-4-phenyl-2-butanol. This absence of documented safety incidents suggests that the compound has not raised acute health concerns in the marketplace. However, it is important to note that the lack of adverse event reports does not constitute official FDA approval or GRAS status.

The compound's chemical structure as a secondary alcohol does not inherently suggest toxicological concern, though comprehensive safety data would be necessary for formal risk assessment. Limited published toxicological studies are available in the public domain for this specific compound, making independent verification of safety characteristics difficult for consumers or regulatory bodies without access to proprietary manufacturer data.

Regulatory Status

2-methyl-4-phenyl-2-butanol does not hold FDA GRAS (Generally Recognized as Safe) designation. This means the compound has not undergone the formal GRAS affirmation process or does not meet the criteria for GRAS status through scientific consensus. Despite not having GRAS status, it may still be permitted for use in food under FDA regulations governing food additives, potentially under specific limitations or prior approval conditions.

In the European Union, regulatory status would be determined under EFSA (European Food Safety Authority) guidelines, though this compound is not prominently listed among major European flavor additive databases. Regulatory acceptance varies by country and region, and manufacturers using this ingredient must comply with local food additive regulations in their target markets.

Key Studies

Publicly available peer-reviewed literature specifically evaluating 2-methyl-4-phenyl-2-butanol is limited. Most safety information for synthetic flavor compounds of this type comes from manufacturer submissions to regulatory agencies, which may not be publicly accessible. General toxicological principles for secondary alcohols suggest evaluation should include acute toxicity, irritation potential, and genetic toxicity testing, though specific study results for this compound are not readily available in scientific literature databases.

The absence of regulatory GRAS status suggests either that formal safety data submission has not been completed, or that submitted data did not meet GRAS criteria. Manufacturers and regulatory agencies maintain more detailed safety information than is typically available to the general public.

Frequently Asked Questions

What is 2-methyl-4-phenyl-2-butanol?

2-methyl-4-phenyl-2-butanol is a synthetic flavoring compound used to impart fruity and floral notes in food and beverage products. It functions as a flavoring agent or adjuvant in the food industry, though it does not currently hold FDA GRAS (Generally Recognized as Safe) status.

Is 2-methyl-4-phenyl-2-butanol safe?

2-methyl-4-phenyl-2-butanol 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 2-methyl-4-phenyl-2-butanol banned in any country?

2-methyl-4-phenyl-2-butanol 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.