Our Verdict: RATING UNKNOWN

P,alpha,alpha-trimethylbenzyl Alcohol

E-numberE1519CAS1197-01-9

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

P,alpha,alpha-trimethylbenzyl Alcohol — food additive

P,alpha,alpha-trimethylbenzyl Alcohol (CAS 1197-01-9) is a synthetic aromatic alcohol used as a flavoring agent in food products. It provides woody, floral, and slightly spicy flavor 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
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 P,alpha,alpha-trimethylbenzyl Alcohol?

P,alpha,alpha-trimethylbenzyl Alcohol, also known as p-tert-butylbenzyl alcohol or 4-tert-butylbenzyl alcohol, is a synthetic organic compound with the molecular formula C11H16O. It is classified as an aliphatic alcohol with aromatic character, derived from benzyl alcohol with a trimethyl (tert-butyl) substituent. The compound exists as a colorless to pale yellow liquid at room temperature and is widely synthesized for use in flavor chemistry.

Common Uses

This additive functions primarily as a flavoring agent and flavor adjuvant in the food and beverage industry. Its characteristic woody, warm, and slightly spicy sensory profile makes it valuable in:

- Alcoholic beverages, particularly spirits and liqueurs

- Non-alcoholic beverages including soft drinks and flavored waters

- Confectionery and candy products

- Baked goods and bakery items

- Dairy products such as flavored yogurts and desserts

- Savory applications including seasonings and sauces

The compound is typically used in very small concentrations, measured in parts per million (ppm), due to its potent aromatic properties. Flavor chemists employ it as a component in complex flavor formulations to add depth and complexity to the overall sensory profile.

Safety Assessment

P,alpha,alpha-trimethylbenzyl Alcohol has not been formally classified as Generally Recognized as Safe (GRAS) by the FDA. However, this classification does not indicate safety concerns; rather, it reflects the regulatory pathway and available safety data submission status. The compound has generated zero adverse event reports in the FDA's database and zero product recalls associated with its use.

The safety profile appears favorable based on available toxicological data. As a flavor compound used in minimal quantities, systemic exposure through dietary consumption is expected to be extremely low. The compound's chemical structure suggests it would be readily metabolized through standard hepatic pathways, though specific metabolism studies are limited in published literature.

No genotoxicity, carcinogenicity, or reproductive toxicity concerns have been identified in available scientific literature. The compound's long history of use in flavor applications without documented adverse events supports its apparent safety record, though additional formal toxicological studies could provide further characterization.

Regulatory Status

In the United States, P,alpha,alpha-trimethylbenzyl Alcohol is not listed on the FDA's GRAS list, meaning it was not formally notified and affirmed through the GRAS notification process. However, it may be used as a flavoring ingredient under FDA regulations 21 CFR 182.60, which permits use of flavoring agents "in the amounts and in the manner as the amounts are generally recognized as safe by experts qualified by scientific training and experience."

The compound is manufactured and supplied by flavor houses that maintain responsibility for safety documentation. Use in food is subject to FDA compliance requirements, and manufacturers must maintain adequate safety data supporting its use. International regulatory bodies, including those in the European Union, have varying approval statuses depending on specific regulatory pathways and data submissions.

Key Studies

Limited published peer-reviewed safety studies specifically address P,alpha,alpha-trimethylbenzyl Alcohol in isolation. Most safety assessments are conducted as part of confidential submissions to regulatory bodies or proprietary flavor safety programs. The compound's structural similarity to other approved aromatic alcohols and benzyl derivatives supports extrapolation of safety data from related compounds.

Industry-sponsored safety assessments conducted by flavor ingredient manufacturers typically include standard toxicology testing. The absence of documented adverse events over decades of use in flavor applications provides real-world safety evidence, though prospective formal studies would further characterize any potential hazards at relevant exposure levels.

Frequently Asked Questions

What is P,alpha,alpha-trimethylbenzyl Alcohol?

P,alpha,alpha-trimethylbenzyl Alcohol (CAS 1197-01-9) is a synthetic aromatic alcohol used as a flavoring agent in food products. It provides woody, floral, and slightly spicy flavor notes to beverages, confectionery, and other processed foods.

Is P,alpha,alpha-trimethylbenzyl Alcohol safe?

P,alpha,alpha-trimethylbenzyl Alcohol 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 P,alpha,alpha-trimethylbenzyl Alcohol banned in any country?

P,alpha,alpha-trimethylbenzyl Alcohol 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.