Our Verdict: RATING UNKNOWN

4-(p-hydroxyphenyl)-2-butanone

CAS5471-51-2

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

4-(p-hydroxyphenyl)-2-butanone โ€” food additive

4-(p-hydroxyphenyl)-2-butanone is an organic compound used as a flavoring agent in food products. It is not approved as a food additive by the FDA and has not been designated as Generally Recognized as Safe (GRAS).

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 4-(p-hydroxyphenyl)-2-butanone?

4-(p-hydroxyphenyl)-2-butanone, identified by CAS Number 5471-51-2, is an organic chemical compound belonging to the class of aromatic ketones. The compound contains a hydroxyphenyl group attached to a butanone backbone, giving it distinct chemical properties relevant to flavor chemistry. Its molecular structure allows it to interact with taste and olfactory receptors, which is the basis for its potential use as a flavoring agent.

Common Uses

This compound is primarily investigated for use as a flavoring agent or flavor adjuvant in the food industry. Flavor adjuvants are substances that enhance, modify, or complement the taste profile of food products. While the compound has potential applications in beverage flavoring, confectionery, and other processed foods, its actual market use appears limited due to regulatory restrictions. The compound may be found in research and development contexts within flavor chemistry, but widespread commercial application in food products is not documented.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with this additive and zero product recalls. This absence of reported incidents does not necessarily indicate comprehensive safety data, but rather reflects limited market exposure. The compound has not undergone the extensive safety evaluation required for FDA GRAS (Generally Recognized as Safe) designation. Without GRAS status or formal FDA approval, the additive cannot be legally added to food products in the United States.

Toxicological data on this specific compound appears limited in publicly available literature. Standard safety evaluations for flavoring agents typically include acute toxicity studies, genotoxicity assessments, and potential metabolic pathways. The phenolic structure of this compound suggests it may undergo hepatic metabolism, though specific metabolic studies would be necessary to confirm safety profiles.

Regulatory Status

In the United States, 4-(p-hydroxyphenyl)-2-butanone is not approved as a food additive by the FDA and does not have GRAS status. This means it cannot be legally added to food products marketed in the U.S. without prior FDA approval through the food additive petition process. The European Food Safety Authority (EFSA) has not listed this compound in its approved flavoring substances database, indicating it is similarly restricted or not evaluated in the European Union.

For an additive to gain GRAS status or FDA approval, manufacturers must submit comprehensive safety data demonstrating that the substance is safe under its intended conditions of use. This typically includes absorption, distribution, metabolism, and excretion (ADME) studies, as well as toxicological assessments.

Key Studies

Publicly available peer-reviewed research specifically on 4-(p-hydroxyphenyl)-2-butanone is limited. Most information regarding this compound comes from chemical databases and regulatory documentation rather than published safety studies. General research on aromatic ketone compounds and phenolic structures provides some context for understanding potential biochemical behavior, but compound-specific safety data would be necessary before regulatory approval could be considered.

The lack of substantial research data is a significant factor in the compound's non-approval status. Regulatory agencies require robust, independent studies demonstrating safety before approving new food additives. Without such data, the additive remains in a regulatory limboโ€”neither approved nor banned, but restricted from use in food products pending further evaluation.

Frequently Asked Questions

What is 4-(p-hydroxyphenyl)-2-butanone?

4-(p-hydroxyphenyl)-2-butanone is an organic compound used as a flavoring agent in food products. It is not approved as a food additive by the FDA and has not been designated as Generally Recognized as Safe (GRAS).

Is 4-(p-hydroxyphenyl)-2-butanone safe?

4-(p-hydroxyphenyl)-2-butanone 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 4-(p-hydroxyphenyl)-2-butanone banned in any country?

4-(p-hydroxyphenyl)-2-butanone 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.