Our Verdict: SAFE

Butyl Valerate

CAS591-68-4

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Butyl Valerate — food additive

Butyl valerate is an organic ester compound used as a flavoring agent in food products. It imparts fruity, apple-like sensory characteristics and is employed in small quantities to enhance the flavor profiles of various processed foods and beverages.

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 Butyl Valerate?

Butyl valerate (CAS Number 591-68-4) is a synthetic organic ester belonging to the class of compounds known as valerate esters. It is produced through the chemical reaction between butanol and valeric acid (pentanoic acid). The compound exists as a colorless to pale yellow liquid with a characteristic fruity odor reminiscent of apples and pears. Its molecular formula is C9H18O2, and it has a molecular weight of 158.24 g/mol.

Common Uses

Butyl valerate is primarily used in the food industry as a flavoring agent and flavor adjuvant. It is employed in formulations for:

- Beverages, including soft drinks and flavored waters

- Confectionery and candy products

- Dairy products such as yogurts and flavored milks

- Baked goods and snack foods

- Desserts and frozen treats

- Savory food products where fruity notes are desired

The compound typically appears in food formulations at very low concentrations, measured in parts per million (ppm), to achieve the desired sensory effect without overwhelming other flavor components. As a food additive, it functions to enhance, modify, or round out existing flavor profiles in processed foods.

Safety Assessment

Butyl valerate has been evaluated for safety in food applications. According to FDA records, there have been zero reported adverse events associated with this additive, and no food product recalls have been linked to butyl valerate contamination or safety concerns. This absence of reported incidents reflects its long history of safe use in food formulations at approved levels.

The compound undergoes metabolism in the human body similar to other short-chain esters and their component alcohols and acids. These metabolic products are generally recognized as normal components of human biochemistry. The low concentrations at which butyl valerate is used in food products mean exposure levels are minimal.

As an ester, butyl valerate is subject to hydrolysis in the acidic environment of the stomach, breaking down into its component parts: butanol and valeric acid. Both components are found naturally in foods and are metabolized through normal pathways.

Regulatory Status

Butyl valerate is not listed as a Generally Recognized as Safe (GRAS) substance by the U.S. Food and Drug Administration. However, it may be used in food under FDA regulations for synthetic flavoring substances and adjuvants, provided it complies with current Good Manufacturing Practice (cGMP) requirements and is used at levels consistent with standard industry practice.

In the European Union, butyl valerate is listed in the Commission Regulation (EC) No 1334/2008 on flavorings and their use in foods, indicating acceptance for use as a flavoring agent within EU member states, subject to specific usage restrictions and limits.

The absence of a GRAS determination does not indicate a safety concern; rather, it reflects that formal GRAS status was not sought or obtained through the FDA's notification process. The additive remains authorized for use under established regulatory frameworks.

Key Studies

While extensive published literature specifically on butyl valerate is limited, safety data on structurally similar esters and their metabolic pathways supports safe use at food-level concentrations. The chemical class of short-chain fatty acid esters has been extensively studied, with established safety profiles.

Regulatory agencies including the FDA and EFSA base their assessments on chemical composition, metabolic fate, exposure levels, and historical use data. The zero reported adverse events and zero recalls associated with butyl valerate indicate no emerging safety signals have been identified through post-market surveillance.

Additional safety margins are provided by the minimal concentrations used in food products, which are typically far below levels that would produce measurable physiological effects based on comparative toxicology data for related compounds.

Frequently Asked Questions

What is Butyl Valerate?

Butyl valerate is an organic ester compound used as a flavoring agent in food products. It imparts fruity, apple-like sensory characteristics and is employed in small quantities to enhance the flavor profiles of various processed foods and beverages.

Is Butyl Valerate safe?

Butyl Valerate is currently rated "safe" 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 Butyl Valerate banned in any country?

Butyl Valerate 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.