Our Verdict: RATING UNKNOWN

Butyl Acetoacetate

CAS591-60-6

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

Butyl Acetoacetate — food additive

Butyl acetoacetate is an organic compound used as a flavoring agent in food products. It is a synthetic chemical that imparts specific taste and aroma characteristics to 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 Acetoacetate?

Butyl acetoacetate (CAS Number: 591-60-6) is a synthetic organic chemical belonging to the class of acetoacetate esters. It is a colorless to pale yellow liquid with a characteristic fruity odor. The compound is composed of a butyl group attached to an acetoacetate moiety, giving it specific chemical properties that contribute to its flavoring applications in the food industry.

Common Uses

Butyl acetoacetate is utilized as a flavoring agent or flavoring adjuvant in food and beverage manufacturing. Its primary application is to provide or enhance fruity and sweet notes in products such as confectionery, baked goods, beverages, and other processed foods. As a flavoring adjuvant, it may also be used to modify or balance the overall sensory profile of food products. The compound is typically used in very small quantities, as is standard practice with synthetic flavoring agents.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with butyl acetoacetate consumption, and no food recalls have been issued related to this additive. This absence of adverse event reports and recalls suggests that the compound has not demonstrated safety concerns in actual food use.

However, it is important to note that butyl acetoacetate is not on the FDA's Generally Recognized as Safe (GRAS) list. GRAS status requires either a history of safe use in food prior to 1958 or extensive scientific evidence demonstrating safety. The lack of GRAS designation does not necessarily indicate that a substance is unsafe, but rather that it has not met the specific criteria for that particular classification within the United States regulatory framework.

The toxicological profile of butyl acetoacetate in animal studies would inform its safety assessment, though comprehensive published data on this specific compound may be limited. As with all food additives, regulatory bodies assess potential risks based on intended use levels, dietary exposure estimates, and available toxicological information.

Regulatory Status

In the United States, butyl acetoacetate is not GRAS-listed by the FDA. This means that while it may be used in food under certain regulatory pathways, it does not have the streamlined approval status that GRAS substances enjoy. Food manufacturers using this additive must comply with applicable FDA regulations regarding food additives and labeling requirements.

Regulatory approval and classification can vary between countries. The European Food Safety Authority (EFSA) and other international regulatory bodies may have different assessments or approvals for this compound. Manufacturers exporting products containing butyl acetoacetate must ensure compliance with the regulations of their target markets.

Key Studies

While specific peer-reviewed studies on butyl acetoacetate's safety in food applications may be limited in public literature, the compound's use in flavoring is based on its chemical properties and sensory characteristics. The absence of adverse events and recalls in FDA databases suggests that any use of this additive has not generated safety signals in the United States market.

Further research or toxicological studies on this specific compound would provide additional data for comprehensive safety assessment. Manufacturers and regulatory bodies rely on existing toxicological data, exposure assessments, and post-market surveillance to monitor safety.

Frequently Asked Questions

What is Butyl Acetoacetate?

Butyl acetoacetate is an organic compound used as a flavoring agent in food products. It is a synthetic chemical that imparts specific taste and aroma characteristics to processed foods and beverages.

Is Butyl Acetoacetate safe?

Butyl Acetoacetate 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 Butyl Acetoacetate banned in any country?

Butyl Acetoacetate 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.