Our Verdict: RATING UNKNOWN

Butyraldehyde

CAS123-72-8

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

Butyraldehyde — food additive

Butyraldehyde is a volatile organic compound with a pungent odor naturally found in some foods. It is used as a flavoring agent to impart butter-like and fruity notes in 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
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 Butyraldehyde?

Butyraldehyde (also known as butanal) is a four-carbon aldehyde with the chemical formula C₄H₈O and CAS number 123-72-8. It is a colorless liquid with a pungent, characteristic odor often described as fruity or rancid. Butyraldehyde occurs naturally in small quantities in various foods, including fermented products, fruits, and dairy items. In food manufacturing, it is synthesized chemically and used as a flavoring agent or flavor adjuvant to enhance or create specific taste profiles.

Common Uses

Butyraldehyde is primarily used in the flavor industry to provide buttery, fruity, and slightly malty notes to foods and beverages. It commonly appears in:

- Processed dairy products and cheese flavoring

- Confectionery and candy formulations

- Baked goods and bakery products

- Fruit-flavored beverages and drinks

- Snack foods and savory products

As a flavor adjuvant, it is typically used in very small quantities—often in the parts per million (ppm) range—to achieve the desired sensory characteristics without making the flavor overwhelming or unpleasant.

Safety Assessment

Butyraldehyde has generated no adverse event reports in FDA databases and has not been associated with any recalls. The compound has been studied for its toxicological profile in laboratory settings. As a naturally occurring compound found in foods, humans have baseline dietary exposure through the natural food supply.

Animal studies have evaluated the acute and subchronic toxicity of butyraldehyde. These studies indicate that it has low to moderate toxicity when ingested in quantity, with effects primarily affecting the gastrointestinal system and liver at high doses. However, the levels used in food flavoring are substantially lower than those used in toxicological testing, providing a considerable margin of safety.

Butyraldehyde is volatile and readily oxidizes in food systems, which may limit its accumulation or persistence. Its use as a flavoring is restricted to intentional additions in small amounts, not as a preservative or processing aid that might accumulate significantly.

Regulatory Status

Butyraldehyde is NOT listed as Generally Recognized As Safe (GRAS) by the FDA. This means it has not received formal GRAS determination and is not approved for use in the United States food supply under the standard GRAS exemption (21 CFR 182 or similar categories).

In the European Union, butyraldehyde is listed in the EFSA flavoring database as a flavoring substance with an acceptable intake level. It has been evaluated by the International Organization of the Flavoring Industry (IOFI) and is permitted in food applications in EU member states.

The regulatory discrepancy between the United States and European Union reflects different approval pathways and assessment timelines rather than significant safety concerns. Any food containing butyraldehyde in the US would require either premarket approval or operation under a petition/allowance specific to the manufacturer.

Key Studies

The flavoring industry and regulatory bodies have conducted limited published research specifically on butyraldehyde. Most safety data derives from:

- General aldehyde toxicology literature

- IOFI submissions to European regulatory authorities

- Occupational exposure studies in chemical manufacturing

- Natural occurrence data in fermented and processed foods

Studies indicate butyraldehyde is rapidly metabolized and does not accumulate in tissues. The no-observed-adverse-effect level (NOAEL) data from animal studies, combined with the minimal exposure from food flavoring use, supports a reasonable margin of safety when used as intended in food manufacturing.

Frequently Asked Questions

What is Butyraldehyde?

Butyraldehyde is a volatile organic compound with a pungent odor naturally found in some foods. It is used as a flavoring agent to impart butter-like and fruity notes in processed foods and beverages.

Is Butyraldehyde safe?

Butyraldehyde 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 Butyraldehyde banned in any country?

Butyraldehyde 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.