Our Verdict: RATING UNKNOWN

P,alpha-dimethylbenzyl Alcohol

E-numberE1519CAS536-50-5

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-dimethylbenzyl Alcohol — food additive

P,alpha-dimethylbenzyl Alcohol (CAS 536-50-5) is an organic compound used as a flavoring agent in food products. It provides aromatic characteristics to beverages and food formulations, though it is not currently approved as Generally Recognized as Safe (GRAS) by the FDA.

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 P,alpha-dimethylbenzyl Alcohol?

P,alpha-dimethylbenzyl Alcohol, also known as alpha,alpha-dimethylbenzyl alcohol or 1-phenylethanol derivative, is an organic aromatic compound with the CAS number 536-50-5. This chemical belongs to the class of benzyl alcohol derivatives and is utilized in the food industry primarily for its flavoring properties. The compound contains a benzene ring with attached methyl groups and a hydroxyl functional group, giving it volatile aromatic characteristics suitable for flavoring applications.

Common Uses

This additive functions as a flavoring agent or flavoring adjuvant in food and beverage products. It is used in small quantities to impart or enhance aromatic notes in various formulations, including soft drinks, alcoholic beverages, confectionery, and processed foods. The compound's aromatic profile makes it valuable in creating complex flavor blends where subtle woody, spicy, or herbal notes are desired. Like other flavor compounds, it would typically be used at parts-per-million (ppm) levels in final food products.

Safety Assessment

P,alpha-dimethylbenzyl Alcohol has not been designated as GRAS (Generally Recognized as Safe) by the FDA, which means it has not undergone the formal FDA approval process for use as a food additive in the United States. However, this classification does not indicate the substance is unsafe; rather, it indicates that formal safety documentation and regulatory approval have not been established through FDA channels.

According to FDA records, there are zero reported adverse events associated with this additive and zero recalls linked to its use in foods. This absence of adverse event reports suggests that if the compound is being used in foods, it has not generated safety concerns significant enough to trigger regulatory action or consumer complaints in the United States.

The compound's safety profile would depend on factors including its purity, concentration in food products, and total dietary exposure. As with many flavor compounds, safety considerations include acute toxicity, potential for accumulation, and any interactions with common food components or medications.

Regulatory Status

In the United States, P,alpha-dimethylbenzyl Alcohol is not approved as a GRAS substance and therefore cannot be legally used as an intentional food additive in foods regulated by the FDA without specific authorization. This means manufacturers seeking to use this compound in food products would need to submit a Food Additive Petition to the FDA for review and approval, or use it only in jurisdictions where it has been approved.

Regulatory status in other countries may differ. The European Union and other regulatory bodies maintain separate lists of approved food additives and flavorings, and this compound may have different approval status in those regions. Food manufacturers operating internationally must comply with regulations in each specific market where their products are sold.

Key Studies

Limited published safety data is available specifically for P,alpha-dimethylbenzyl Alcohol in peer-reviewed literature, which is one reason formal GRAS status has not been established. Safety evaluations for such compounds typically examine acute and chronic toxicity data, genotoxicity potential, and reproductive or developmental effects. The absence of FDA adverse event reports and recalls suggests either minimal use in foods or a favorable safety profile under current usage conditions, though absence of reports does not constitute definitive proof of safety without formal toxicological assessment.

Comprehensive safety data would typically include animal studies, absorption and metabolism information, and risk assessment calculations comparing expected dietary exposure to safe levels identified in toxicological studies. Manufacturers interested in using this additive would need to develop or compile such data for regulatory submission.

Frequently Asked Questions

What is P,alpha-dimethylbenzyl Alcohol?

P,alpha-dimethylbenzyl Alcohol (CAS 536-50-5) is an organic compound used as a flavoring agent in food products. It provides aromatic characteristics to beverages and food formulations, though it is not currently approved as Generally Recognized as Safe (GRAS) by the FDA.

Is P,alpha-dimethylbenzyl Alcohol safe?

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

P,alpha-dimethylbenzyl 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.