Our Verdict: RATING UNKNOWN

Butyl Butyryllactate

CAS7492-70-8

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

Butyl Butyryllactate — food additive

Butyl butyryllactate is a synthetic flavoring compound used to impart buttery and creamy notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, 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 Butyl Butyryllactate?

Butyl butyryllactate (CAS Number: 7492-70-8) is a synthetic organic compound belonging to the ester class of flavoring agents. It is composed of butyric acid combined with a lactate structure, modified with a butyl group. This chemical structure gives it characteristics that make it useful as a flavoring adjuvant in the food industry. Like many synthetic flavoring compounds, it is designed to mimic or enhance natural flavor profiles, particularly those associated with dairy, butter, and creamy taste sensations.

Common Uses

Butyl butyryllactate is used primarily as a flavoring agent in processed foods where buttery or creamy flavor notes are desired. Its applications may include dairy-based products, baked goods, confectionery, and other processed foods where flavor enhancement is sought. The compound functions as a flavoring adjuvant, meaning it may be used to support, enhance, or modify the overall flavor profile of a food product rather than serve as a primary flavoring ingredient.

The specific concentration levels and food categories in which this compound is used are determined by manufacturers based on their formulation needs and regulatory compliance in their respective markets.

Safety Assessment

According to FDA records, butyl butyryllactate has generated zero adverse event reports and zero product recalls. This absence of reported safety incidents suggests that any food products containing this additive have not been associated with consumer health complaints or safety concerns significant enough to warrant regulatory action or public health alerts.

However, the absence of adverse events does not automatically equate to comprehensive safety data. It may reflect limited market use, limited consumer exposure, or simply that serious adverse effects have not been documented through FDA reporting channels. Safety assessment typically requires toxicological studies, including acute and chronic toxicity testing, to establish safe usage levels.

For synthetic flavoring compounds, the FDA typically evaluates safety through the Generally Recognized as Safe (GRAS) process or through food additive petitions. The GRAS designation indicates that a substance is recognized by qualified experts as safe for its intended use based on scientific procedures or, alternatively, based on a history of safe use prior to 1958.

Regulatory Status

Butyl butyryllactate is not currently listed as GRAS by the FDA. This status means it does not have blanket FDA approval for use in foods as a Generally Recognized as Safe substance. Manufacturers wishing to use this ingredient in the United States would need to either establish a history of safe use or submit a food additive petition to the FDA for evaluation.

In the European Union, regulatory approval of flavoring agents is governed by the European Food Safety Authority (EFSA) and specific EU regulations. Different countries maintain their own lists of approved flavoring substances, and availability of this compound may vary by region.

The non-GRAS status does not indicate that the substance is unsafe; rather, it indicates that it has not undergone or completed the FDA's formal approval process for this designation.

Key Studies

Publicly available toxicological data specific to butyl butyryllactate appears limited in the peer-reviewed scientific literature. The compound's chemical structure suggests it would undergo typical ester metabolism in the body, similar to other butyryllactate compounds. However, specific absorption, distribution, metabolism, and excretion (ADME) studies for this particular compound are not readily documented in accessible scientific databases.

Further research and toxicological assessment would be necessary to establish definitive safe usage levels and confirm its safety profile for long-term dietary exposure. Interested parties can review FDA flavor ingredient databases and petition records for any additional technical assessments or manufacturer submissions related to this compound.

Frequently Asked Questions

What is Butyl Butyryllactate?

Butyl butyryllactate is a synthetic flavoring compound used to impart buttery and creamy notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has no recorded adverse events or recalls associated with its use.

Is Butyl Butyryllactate safe?

Butyl Butyryllactate 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 Butyryllactate banned in any country?

Butyl Butyryllactate 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.