Our Verdict: RATING UNKNOWN

2,5-xylenol

CAS95-87-4

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

2,5-xylenol — food additive

2,5-xylenol is a synthetic aromatic compound used as a flavoring agent and flavor enhancer in food products. It belongs to the xylenol family of chemicals and is employed to provide or modify taste profiles in various 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 2,5-xylenol?

2,5-xylenol (CAS Number 95-87-4) is a synthetic organic compound belonging to the class of methylphenols, commonly known as xylenols. It is a colorless to pale yellow liquid or crystalline solid with a characteristic phenolic odor. The chemical structure consists of a benzene ring with two methyl groups and one hydroxyl group in the 2,5-positions. Due to its aromatic properties, it functions as a flavoring substance in the food industry.

Common Uses

2,5-xylenol is utilized in food manufacturing as a flavor enhancer and flavoring agent adjuvant. Its primary application is in the development of complex flavor profiles in processed foods, beverages, and food additives. The compound contributes aromatic notes that can enhance or modify the perception of taste in finished food products. It is typically used in very small quantities, as is standard practice with synthetic flavoring compounds. The specific foods that may contain this additive vary depending on formulation needs and regional food manufacturing practices.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 2,5-xylenol consumption, and no FDA recalls have been issued for products containing this substance. The absence of adverse event reports suggests that at the levels used in food applications, this compound has not generated safety concerns in the U.S. food supply.

Toxicological data on 2,5-xylenol indicates that it exhibits low acute toxicity. Like other xylenols, it has been studied for potential systemic effects, though comprehensive long-term dietary studies specific to food use levels are limited in the public domain. The compound's safety profile is generally considered acceptable for use at the concentrations employed in flavoring applications, where exposure levels are typically very low.

Regulatory Status

2,5-xylenol is not listed on the FDA's Generally Recognized As Safe (GRAS) list. However, this does not indicate that the substance is unsafe or prohibited; rather, it means it has not undergone the formal GRAS notification process or has not been affirmed as GRAS through FDA review. The absence of GRAS status suggests that manufacturers using this additive may be required to comply with FDA regulations for food additives requiring premarket approval.

In the European Union, regulatory frameworks for flavoring substances are established under Regulation (EC) No 1334/2008. Xylenols and related compounds may be subject to specific approvals and usage levels depending on the jurisdiction. International regulatory approaches to 2,5-xylenol vary, with some regions permitting its use under established guidelines while others may have different classifications or restrictions.

Key Studies

While specific peer-reviewed studies focused exclusively on 2,5-xylenol in food applications are limited in readily available literature, the broader xylenol chemical class has undergone toxicological assessment. Research on methylphenol compounds indicates that absorption and metabolism occur through hepatic and renal pathways, with relatively rapid elimination from the body.

Toxicological evaluations of structurally similar compounds suggest that xylenols have acceptable safety margins when used at concentrations typical in food flavoring. The absence of regulatory bans or significant restrictions in major food markets indicates that available safety data has been deemed sufficient by regulatory agencies for continued use.

Manufacturers and regulatory bodies continue to monitor the safety of all flavoring substances, including 2,5-xylenol, through post-market surveillance systems. Updated safety assessments may be conducted if new scientific evidence emerges or if usage patterns change significantly.

Frequently Asked Questions

What is 2,5-xylenol?

2,5-xylenol is a synthetic aromatic compound used as a flavoring agent and flavor enhancer in food products. It belongs to the xylenol family of chemicals and is employed to provide or modify taste profiles in various processed foods.

Is 2,5-xylenol safe?

2,5-xylenol 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 2,5-xylenol banned in any country?

2,5-xylenol 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.