Our Verdict: SAFE

Linalyl Butyrate

CAS78-36-4

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

Linalyl Butyrate — food additive

Linalyl butyrate (CAS 78-36-4) is a synthetic flavoring compound that occurs naturally in some fruits and flowers. It is used in food and beverage products to provide fruity and floral flavor notes.

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
ApprovedHealth 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 Linalyl Butyrate?

Linalyl butyrate is an ester compound formed from the combination of linalool (an alcohol) and butyric acid. It is classified as a synthetic flavoring agent, though structurally similar compounds exist in nature. The compound is known for its fruity, floral, and slightly herbal aromatic profile, making it useful in creating complex flavor blends for food and beverage applications.

Common Uses

Linalyl butyrate is primarily used as a flavoring ingredient in the food and beverage industry. Its applications include:

- Flavoring in beverages such as soft drinks, juices, and alcoholic drinks

- Flavoring in confectionery products and desserts

- Flavoring in baked goods and grain-based products

- Component in flavor compounds for dairy products

- Use in non-alcoholic and alcoholic beverage formulations

The compound contributes fruity and floral notes that enhance the sensory profile of finished products. It is typically used in very small quantities, as is standard practice with concentrated flavoring agents.

Safety Assessment

Linalyl butyrate has not been formally approved as a GRAS (Generally Recognized As Safe) substance by the FDA. However, this designation does not indicate a safety concern; rather, it reflects the regulatory classification pathway chosen by manufacturers and the FDA's review status.

Key safety data points include:

- Zero adverse events reported to the FDA

- Zero product recalls associated with this compound

- No documented serious health effects from normal food use exposure levels

- The compound is structurally similar to naturally occurring esters in foods

The absence of adverse event reports and recalls suggests that any exposure through food consumption has not resulted in identified safety issues. Regulatory agencies globally maintain surveillance systems to identify potential safety concerns, and no such concerns have been flagged for this ingredient.

Regulatory Status

The regulatory status of linalyl butyrate varies by jurisdiction:

**United States:** While not GRAS-designated, the compound may be used under FDA flavor regulations. The FDA's Flavor and Extract Manufacturers' Association (FEMA) maintains the Generally Recognized As Safe (GRAS) list for flavoring agents, and regulatory pathways exist for flavoring ingredients that have not undergone formal GRAS affirmation.

**European Union:** The European Food Safety Authority (EFSA) maintains comprehensive databases and regulations for flavoring substances. Linalyl butyrate may be listed in the Union List of flavoring substances permitted in foodstuffs depending on specific product categories and use levels.

**International:** Other regulatory bodies, including those in Canada, Australia, and Japan, maintain their own approval processes for flavoring ingredients. The regulatory status may differ based on jurisdiction-specific requirements and food categories.

Manufacturers using this ingredient are responsible for ensuring compliance with local regulations where their products are sold.

Key Studies

Published scientific literature on linalyl butyrate remains limited compared to more widely studied food additives. Research on related compounds provides relevant context:

- Studies on linalool, the alcohol component, demonstrate low toxicity in food-related exposure levels

- Ester compounds generally show favorable safety profiles when used as flavoring agents

- The compound's structural similarity to natural flavor components suggests low inherent hazard

The absence of specific clinical studies on linalyl butyrate does not indicate unsafe use; rather, it reflects that flavoring ingredients are typically studied as component groups rather than individually when exposure levels are minimal. Regulatory safety assessments are conducted by flavor manufacturers and reviewed by regulatory authorities based on available toxicological data and use patterns.

Frequently Asked Questions

What is Linalyl Butyrate?

Linalyl butyrate (CAS 78-36-4) is a synthetic flavoring compound that occurs naturally in some fruits and flowers. It is used in food and beverage products to provide fruity and floral flavor notes.

Is Linalyl Butyrate safe?

Linalyl Butyrate 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 Linalyl Butyrate banned in any country?

Linalyl Butyrate 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.