Our Verdict: RATING UNKNOWN

Propyl Butyrate

CAS105-66-8

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

Propyl Butyrate — food additive

Propyl butyrate (CAS 105-66-8) is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity and buttery flavor notes and is employed in various processed foods, beverages, and flavor formulations to enhance taste profiles.

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 Propyl Butyrate?

Propyl butyrate is a short-chain ester formed from propionic acid and butanol. It appears as a colorless to pale yellow liquid with a characteristic fruity aroma. The compound is classified as a synthetic flavoring agent and is used in trace amounts to provide fruity, pineapple-like, and buttery flavor characteristics to food and beverage products. As a volatile organic compound, it readily evaporates, making it suitable for applications where aroma contribution is desired.

Common Uses

Propyl butyrate is primarily used in the flavor industry as a component in synthetic flavor formulations. Its applications include:

- Fruit-flavored beverages and soft drinks

- Dairy products (yogurts, ice creams, flavored milk)

- Confectionery and candy products

- Baked goods and bakery items

- Processed snack foods

- Chewing gums and mints

- Flavor compounds in food manufacturing

The additive is typically used in extremely small concentrations—typically parts per million—to achieve the desired flavor effect without contributing significantly to the nutritional composition of food products.

Safety Assessment

Propyl butyrate has not been formally evaluated for GRAS (Generally Recognized As Safe) status by the FDA, meaning it does not have explicit FDA approval as a food additive for use in the United States. However, the compound has generated zero adverse event reports in the FDA database and has been associated with zero recalls, suggesting no documented safety incidents from its use in food applications.

The chemical structure of propyl butyrate is relatively simple and similar to compounds that occur naturally in foods. As an ester, it can undergo hydrolysis in the digestive system, breaking down into butyric acid and propanol, both of which are metabolized through normal biochemical pathways. The acute toxicity of propyl butyrate in animal studies is low, and there is no evidence of chronic toxicity, carcinogenicity, mutagenicity, or reproductive effects at the minute levels used in food flavoring.

Exposure through food consumption is minimal due to the trace quantities employed in flavor formulations. Flavor ingredients are typically used at levels of 1-100 parts per million in final food products, and propyl butyrate often represents only a fraction of the total flavor compound mixture.

Regulatory Status

The regulatory status of propyl butyrate varies internationally. While it lacks FDA GRAS status in the United States, it may be regulated differently in other jurisdictions. In the European Union, flavor substances are evaluated by EFSA (European Food Safety Authority), though propyl butyrate's specific regulatory classification may vary. Some regions may permit its use under general flavor regulations without explicit pre-approval, while others require specific authorization.

Manufacturers using propyl butyrate must comply with local flavor ingredient regulations and labeling requirements in their respective markets. The lack of FDA GRAS status does not necessarily indicate a safety concern; rather, it reflects that formal GRAS petition or pre-market notification has not been submitted to or approved by the FDA for this particular substance.

Key Studies

Limited published peer-reviewed research specifically addresses propyl butyrate as a food additive. Most safety data comes from general toxicology studies on short-chain esters and flavor compounds. The low acute toxicity profile of similar ester compounds and the absence of adverse event reports suggest propyl butyrate operates within acceptable safety margins when used as intended in flavoring applications.

The absence of recalls and adverse events despite potential decades of use in flavor formulations provides real-world evidence of safety at permitted use levels. However, comprehensive modern safety studies following current guidelines would strengthen the evidence base for this additive.

Frequently Asked Questions

What is Propyl Butyrate?

Propyl butyrate (CAS 105-66-8) is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity and buttery flavor notes and is employed in various processed foods, beverages, and flavor formulations to enhance taste profiles.

Is Propyl Butyrate safe?

Propyl Butyrate 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 Propyl Butyrate banned in any country?

Propyl 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.