Our Verdict: RATING UNKNOWN

Hexadecyl Lactate

CAS35274-05-6

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

Hexadecyl Lactate — food additive

Hexadecyl lactate is a synthetic ester compound derived from lactic acid and hexadecanol, used as a flavoring agent and sensory adjuvant in food products. It functions to enhance or modify flavor profiles 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
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 Hexadecyl Lactate?

Hexadecyl lactate (CAS Number: 35274-05-6) is a synthetic ester compound formed through the combination of lactic acid and hexadecanol (a 16-carbon fatty alcohol). As a flavoring agent, it belongs to the broader category of flavor compounds used in the food industry to enhance, modify, or create specific taste and aroma characteristics. The compound exists as a liquid or semi-solid at room temperature and has limited water solubility, which influences its application in food formulations.

Common Uses

Hexadecyl lactate is utilized primarily as a flavoring agent and flavor adjuvant in processed food products. Its applications include use in beverages, dairy products, confectionery, and other processed foods where flavor modification or enhancement is desired. As a flavor compound, it typically appears in formulations at low concentrations, where even small amounts can contribute to the overall sensory profile of the finished product. The compound's chemical structure allows it to interact with taste and olfactory receptors, contributing to perceived flavor complexity.

Safety Assessment

According to FDA records, there have been zero adverse events reported for hexadecyl lactate and zero product recalls associated with this compound. The absence of documented safety concerns in the FDA adverse event database suggests that the substance, when used in food applications, has not raised significant safety red flags based on consumer reports or industry data.

The toxicological profile of hexadecyl lactate has not been extensively documented in published peer-reviewed literature. Like many specialty flavor compounds, comprehensive safety studies may be limited. The compound's structure—combining lactic acid (a naturally occurring substance present in fermented foods) with hexadecanol—suggests it may follow metabolic pathways similar to other fatty acid esters in the body. However, this structural similarity does not constitute definitive safety data.

Regulatory Status

Hexadecyl lactate has not been approved as GRAS (Generally Recognized as Safe) by the FDA. This status indicates that the compound does not have the elevated regulatory standing that some flavor substances possess. However, it is important to note that lack of GRAS status does not necessarily indicate a safety concern; rather, it reflects the level of evidence, industry usage history, and documentation available for regulatory review.

The compound may be permitted in food products through other regulatory pathways, such as the food additive petition process or through inclusion in food contact substance regulations, depending on its specific intended use and concentration. Regulatory approval and permissible use levels vary by country and region, with different standards in the European Union, United States, and other jurisdictions.

Key Studies

Published scientific literature specifically addressing hexadecyl lactate's safety or efficacy in food applications is limited. Most information available comes from industry technical documentation and regulatory submissions rather than independent academic research. The lack of extensive published studies reflects the reality that many specialty flavor compounds are used at such low levels that formal toxicological assessment is not always prioritized.

For flavor compounds generally, regulatory agencies including the FDA evaluate safety based on chemical structure, proposed use levels, potential metabolites, and any available toxicity data. The evaluation of hexadecyl lactate would follow similar principles, considering its chemical composition and intended use concentration.

Further research and safety documentation would strengthen the evidence base for this compound's use in food applications, particularly any studies examining metabolism, potential accumulation, and long-term exposure effects at realistic dietary levels.

Frequently Asked Questions

What is Hexadecyl Lactate?

Hexadecyl lactate is a synthetic ester compound derived from lactic acid and hexadecanol, used as a flavoring agent and sensory adjuvant in food products. It functions to enhance or modify flavor profiles in processed foods and beverages.

Is Hexadecyl Lactate safe?

Hexadecyl Lactate 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 Hexadecyl Lactate banned in any country?

Hexadecyl Lactate 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.