Our Verdict: RATING UNKNOWN

4-methylbiphenyl

E-numberE230CAS644-08-6

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-methylbiphenyl — food additive

4-Methylbiphenyl 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 limited use in the global food industry.

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-Methylbiphenyl?

4-Methylbiphenyl, also known as p-methylbiphenyl or 4-tolylbenzene, is an organic aromatic compound with the chemical formula C₁₃H₁₂. It belongs to the biphenyl family of compounds and consists of two benzene rings connected by a single bond, with a methyl group attached to one ring in the para position. The compound has a molecular weight of approximately 168.23 g/mol and appears as a white to off-white crystalline solid.

Chemically, 4-methylbiphenyl is structurally related to biphenyl compounds, which have been studied for various industrial and food applications. The addition of the methyl group creates a distinct aromatic profile that has been proposed for use in flavoring applications.

Common Uses

4-Methylbiphenyl is classified as a flavoring agent or flavoring adjuvant. In food applications where permitted, it has been proposed primarily as a component in complex flavor systems rather than as a standalone ingredient. The compound would theoretically contribute aromatic and potentially woody or slightly spicy notes to food formulations.

However, due to its non-GRAS status in the United States and regulatory restrictions in many jurisdictions, its actual use in food products is extremely limited. It may be encountered more frequently in research settings or in jurisdictions with different regulatory frameworks than in consumer food products.

Safety Assessment

The safety profile of 4-methylbiphenyl in food applications remains relatively understudied compared to widely approved food additives. The FDA has not classified this compound as Generally Recognized As Safe (GRAS), which is a significant regulatory distinction. The absence of reported adverse events to the FDA and the absence of FDA recalls associated with this compound suggest that either minimal exposure has occurred in the U.S. food supply or no safety incidents have been documented.

Toxicological data on 4-methylbiphenyl is limited in the published literature. Some biphenyl derivatives have raised historical concerns regarding potential bioaccumulation or persistence in biological systems, though evidence specific to 4-methylbiphenyl is sparse. The European Food Safety Authority (EFSA) has not provided a comprehensive safety assessment for this specific compound as a food flavoring agent.

Absorption, metabolism, and excretion patterns for 4-methylbiphenyl in humans are not well-characterized in available scientific literature. Without substantial toxicological and bioavailability data, definitive safety conclusions cannot be made with certainty.

Regulatory Status

4-Methylbiphenyl is not approved as a food additive by the FDA and does not have GRAS status in the United States. This means it cannot be legally used as a flavoring agent in FDA-regulated food products without a food additive petition and formal FDA approval.

Globally, regulatory status varies by jurisdiction. The compound may have limited approval in some countries or may be prohibited in others. Manufacturers seeking to use this compound would need to verify compliance with specific regional food safety regulations before any food application.

The non-GRAS determination by the FDA reflects insufficient evidence of safe use history or inadequate toxicological data to support food-use applications.

Key Studies

Published peer-reviewed research specifically evaluating 4-methylbiphenyl for food safety or flavoring applications is notably limited. The compound appears more frequently in chemical synthesis literature and industrial chemistry contexts than in food safety or toxicology research.

General research on biphenyl and methylated biphenyl derivatives suggests these compounds possess various chemical properties, but food-specific safety evaluations are lacking. Any organization considering use of this compound would need to sponsor independent toxicological studies to support a regulatory petition.

The absence of substantial published safety data is a primary factor in the lack of regulatory approval for food applications.

Frequently Asked Questions

What is 4-methylbiphenyl?

4-Methylbiphenyl 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 limited use in the global food industry.

Is 4-methylbiphenyl safe?

4-methylbiphenyl 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-methylbiphenyl banned in any country?

4-methylbiphenyl 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.