Our Verdict: RATING UNKNOWN

Amyl Formate

CAS638-49-3

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

Amyl Formate โ€” food additive

Amyl formate (CAS 638-49-3) is an organic ester compound used as a flavoring agent and flavor enhancer in food products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) substance, though it has no recorded adverse events or recalls associated with its use.

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 Amyl Formate?

Amyl formate is an organic compound belonging to the ester family, specifically the formate ester of amyl alcohol (pentanol). With the chemical formula C6H12O2 and CAS number 638-49-3, this volatile liquid is characterized by its fruity, pleasant odor. Esters like amyl formate are commonly found in nature as components of fruit flavors and aromas, and many are used synthetically in food and beverage applications to replicate or enhance these natural flavors.

Common Uses

Amyl formate is utilized primarily as a flavoring agent and flavor enhancer in the food and beverage industry. Its fruity aroma makes it suitable for applications in beverages, confectionery, baked goods, and other processed food products where fruit-like or pleasant aromatic notes are desired. As a volatile ester, it contributes to the overall sensory profile of products by providing both olfactory and taste components that consumers associate with specific fruit flavors.

The compound is also used in non-food applications, including cosmetics and industrial uses, though the focus here is on its food-related applications.

Safety Assessment

Amyl formate has no recorded adverse events in the FDA database and has not been associated with any food recalls. However, the absence of reported incidents does not automatically indicate comprehensive safety approval. The compound's safety profile is limited by the fact that it has not undergone the full FDA GRAS (Generally Recognized as Safe) review and affirmation process, which involves substantial scientific documentation and expert consensus.

As with many flavor compounds, amyl formate is volatile and is typically used at very low concentrations in food productsโ€”often measured in parts per million (ppm). At these usage levels, systemic exposure to consumers is minimal. The ester is likely metabolized relatively quickly in the body, similar to other esters, though comprehensive toxicological data on this specific compound in food applications is limited in the public domain.

Any assessment of safety should consider that flavor compounds are used in very small quantities, and the total dietary exposure to any single flavoring agent is typically negligible compared to major food components.

Regulatory Status

Amyl formate is not approved by the FDA as a GRAS substance. This means it has not received formal FDA recognition as safe for its intended use in food. However, not being GRAS-listed does not mean the substance is unsafe or prohibited; rather, it indicates that the additive would require specific FDA approval through the food additive petition process before being legally used in foods, or it may be used under certain regulatory frameworks in other countries.

The European Food Safety Authority (EFSA) and other international regulatory bodies maintain their own assessments of flavoring compounds. Some esters similar to amyl formate have been evaluated and approved for use in the European Union under the Flavourings Regulation (EC) No 1334/2008, though specific information on amyl formate's status in these systems should be verified directly with regulatory sources.

Key Studies

Publicly available scientific literature specifically addressing the safety and toxicology of amyl formate in food applications is limited. Most information on related esters and formates comes from broader toxicological studies on ester classes. The lack of FDA adverse event reports and recalls suggests that, if this compound has been used in foods, it has not generated safety signals.

For regulatory approval or broader commercial use in the United States, a food additive petition with supporting safety data would likely be necessary. Any substantive use would benefit from additional toxicological testing, including acute and chronic studies, to establish a clear safety profile and appropriate use levels.

Frequently Asked Questions

What is Amyl Formate?

Amyl formate (CAS 638-49-3) is an organic ester compound used as a flavoring agent and flavor enhancer in food products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) substance, though it has no recorded adverse events or recalls associated with its use.

Is Amyl Formate safe?

Amyl Formate 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 Amyl Formate banned in any country?

Amyl Formate 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.