Our Verdict: RATING UNKNOWN

4-(1,1-dimethylethyl)phenol

CAS98-54-4

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-(1,1-dimethylethyl)phenol — food additive

4-(1,1-dimethylethyl)phenol, also known as 4-tert-butylphenol, is an organic compound used as a flavoring agent or flavoring adjuvant in food products. It is not approved as a food additive by the FDA and has not been assigned GRAS (Generally Recognized as Safe) status for food use.

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-(1,1-dimethylethyl)phenol?

4-(1,1-dimethylethyl)phenol is a synthetic organic chemical compound with the CAS number 98-54-4. The compound consists of a phenol group with a tert-butyl substituent (1,1-dimethylethyl group) attached at the para position. It is also commonly referred to as 4-tert-butylphenol or p-tert-butylphenol. The molecular structure makes it a lipophilic (fat-soluble) compound with phenolic properties.

Common Uses

This compound is classified as a flavoring agent or flavoring adjuvant, suggesting its intended role is to contribute to or enhance the flavor profile of food products. As a flavoring substance, it would theoretically be used in very small quantities to provide or modify taste and aroma characteristics. However, due to its non-GRAS status in the United States, its actual use in foods intended for consumption is limited or prohibited.

Outside of food applications, 4-tert-butylphenol has industrial applications as an antioxidant in lubricants, polymers, and other chemical products, though these uses are distinct from food flavoring applications.

Safety Assessment

Limited published safety data exists specifically for 4-(1,1-dimethylethyl)phenol as a food additive. The FDA has received no adverse event reports associated with this substance, and no food recalls have been linked to it. However, the absence of reported adverse events does not constitute proof of safety, as limited use or approval in foods would naturally result in minimal exposure and thus minimal opportunity for adverse events to be detected.

The phenolic structure of this compound is noteworthy from a toxicological perspective. Phenolic compounds can exhibit varying degrees of biological activity depending on their specific structure and substitution patterns. The tert-butyl group may influence the compound's metabolism and bioavailability. General toxicological data on structurally similar phenolic compounds suggests the need for adequate safety evaluation before food use approval.

Regulatory Status

4-(1,1-dimethylethyl)phenol has not been approved by the FDA as a food additive and does not have GRAS status in the United States. This means it cannot be legally used in foods intended for human consumption within the U.S. market without specific FDA authorization or GRAS determination.

In the European Union, this substance is also not listed as an approved flavoring substance under the European Food Safety Authority's regulations on flavorings. The EFSA has not conducted a formal safety assessment for use of this compound as a food additive.

For any substance to gain approval as a food additive or flavoring, comprehensive safety data including toxicological studies, metabolism information, and potential cumulative dietary exposure assessments are typically required.

Key Studies

Published scientific literature specifically addressing 4-(1,1-dimethylethyl)phenol's safety as a food flavoring is minimal. The compound has primarily been studied in industrial and chemical contexts rather than food safety applications. Most available data relates to its use as an antioxidant stabilizer in non-food polymeric materials.

Toxicological studies on phenolic compounds in general suggest that acute toxicity is relatively low, but chronic effects and potential metabolic interactions warrant further investigation for any compound proposed for food use. Any petition for food additive approval or GRAS determination would require submission of comprehensive safety data to regulatory authorities for review.

Frequently Asked Questions

What is 4-(1,1-dimethylethyl)phenol?

4-(1,1-dimethylethyl)phenol, also known as 4-tert-butylphenol, is an organic compound used as a flavoring agent or flavoring adjuvant in food products. It is not approved as a food additive by the FDA and has not been assigned GRAS (Generally Recognized as Safe) status for food use.

Is 4-(1,1-dimethylethyl)phenol safe?

4-(1,1-dimethylethyl)phenol 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-(1,1-dimethylethyl)phenol banned in any country?

4-(1,1-dimethylethyl)phenol 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.