Our Verdict: SAFE

5-hydroxy-4-methylhexanoic Acid Delta-lactone

CAS10413-18-0

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

5-hydroxy-4-methylhexanoic Acid Delta-lactone — food additive

5-hydroxy-4-methylhexanoic Acid Delta-lactone (also known as mapleine or maple lactone) is a naturally-derived flavoring compound that imparts maple and creamy notes to food products. It is used in small quantities as a flavoring agent in beverages, dairy products, and confectionery items.

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 5-hydroxy-4-methylhexanoic Acid Delta-lactone?

5-hydroxy-4-methylhexanoic Acid Delta-lactone is a cyclic ester compound classified as a lactone. Its CAS number is 10413-18-0. This flavoring agent occurs naturally in maple syrup and other plant sources, though it is typically synthesized for commercial food applications. The compound belongs to the family of organic compounds used to enhance or modify the flavor profile of food and beverage products. Its chemical structure allows it to provide distinctive maple, woody, and creamy sensory notes at very low concentrations.

Common Uses

This lactone is primarily employed in the food industry as a flavoring agent or flavor adjuvant. Common applications include:

- Dairy products such as yogurts, ice creams, and flavored milk beverages

- Confectionery items including candies and chocolate products

- Baked goods and pastries

- Maple-flavored syrups and toppings

- Beverage applications including coffee and tea products

- Nutritional supplements and protein products

Typical usage levels are very low, generally in the range of parts per million (ppm), reflecting the intense flavor profile of lactone compounds. The specific concentration used depends on the desired flavor intensity and the food matrix in which it is incorporated.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 5-hydroxy-4-methylhexanoic Acid Delta-lactone, and no food recalls have been linked to this additive. The absence of adverse event reports and recalls provides a baseline indicator of safety in actual food supply conditions.

The compound's safety profile is supported by its low usage levels and its origin as a naturally-occurring substance. Lactone compounds in general have been extensively studied, and many are recognized as safe flavoring ingredients in food applications. The low concentrations at which this compound is used further contribute to its safety margin.

As with all food additives, safety depends on both the intrinsic properties of the substance and the conditions of use, including concentration levels and frequency of consumption. The flavoring industry maintains strict quality standards and purity specifications for such compounds to ensure safety and consistency.

Regulatory Status

It is important to note that this additive has not been formally designated as GRAS (Generally Recognized As Safe) by the FDA. However, the absence of a GRAS designation does not necessarily indicate a safety concern. GRAS status represents a specific regulatory determination based on scientific procedures or common use in food prior to 1958. Many flavoring agents function in commerce without formal GRAS status, operating under FDA regulations for food additives or as components of flavoring preparations that comply with FDA guidelines.

The compound is used in various food products available in the United States market as part of flavoring preparations. Manufacturers using this ingredient are responsible for ensuring compliance with FDA regulations governing food additives and flavoring substances. In the European Union, similar lactone-based flavorings are assessed and listed in the EFSA's flavoring database.

Key Studies

Lactone compounds as a class have been the subject of extensive scientific research. Studies on structurally similar lactones have evaluated their metabolic pathways, toxicological profiles, and flavor efficacy. The general understanding is that lactones are readily metabolized and do not bioaccumulate in tissues.

The specific flavor chemistry of 5-hydroxy-4-methylhexanoic Acid Delta-lactone has been characterized in sensory science literature, documenting its organoleptic properties and threshold detection levels. Its maple-like character has made it valuable in flavor chemistry research.

While targeted toxicological studies specific to this exact compound may be limited in publicly available literature, the broader body of evidence on lactone safety, combined with zero adverse event reports and the compound's low usage levels, provides reasonable assurance of safety under normal food use conditions.

Frequently Asked Questions

What is 5-hydroxy-4-methylhexanoic Acid Delta-lactone?

5-hydroxy-4-methylhexanoic Acid Delta-lactone (also known as mapleine or maple lactone) is a naturally-derived flavoring compound that imparts maple and creamy notes to food products. It is used in small quantities as a flavoring agent in beverages, dairy products, and confectionery items.

Is 5-hydroxy-4-methylhexanoic Acid Delta-lactone safe?

5-hydroxy-4-methylhexanoic Acid Delta-lactone is currently rated "safe" 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 5-hydroxy-4-methylhexanoic Acid Delta-lactone banned in any country?

5-hydroxy-4-methylhexanoic Acid Delta-lactone 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.