BUTYL LEVULINATE

CAS: 2052-15-5 FLAVORING AGENT OR ADJUVANT

Butyl levulinate is a synthetic ester used primarily as a flavouring agent in foods under specified regulatory conditions by FDA and evaluated internationally by JECFA as a flavouring substance.

What It Is

Butyl levulinate is a synthetic organic ester identified by the Chemical Abstracts Service registry number 2052-15-5 and classified for use as a flavouring agent or adjuvant in food products. It belongs to a class of compounds known as esters, produced through the esterification of levulinic acid with n-butanol, and has multiple synonym names reflecting its chemical structure and derivations. As with other flavouring agents, butyl levulinate contributes primarily to sensory properties and is used at very low levels for its technical effect rather than for nutritional contribution. Its recognised regulatory function in the United States is under the synthetic flavouring substances and adjuvants provision of food additive regulations. This compound is evaluated internationally by expert bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA), with an assigned flavouring compound number, reflecting its consideration in regulatory science frameworks for food safety and use conditions by authoritative agencies worldwide.

How It Is Made

Butyl levulinate is synthesised through a classical esterification reaction where levulinic acid, derived from the processing of biomass or carbohydrates, reacts with an alcohol, typically n-butanol, in the presence of an acid catalyst to form the ester linkage. This high-level process is consistent with general esterification chemistry used for flavouring ester production. In industrial practice, production methods aim to achieve high purity suitable for food use, and the resulting product undergoes purification steps to meet specifications required by regulatory agencies or specifications for flavouring substances. Analytical methods such as infrared spectroscopy or gas chromatography are commonly employed for verification of identity and purity. Because it is a synthetic flavouring ingredient, manufacturing practices emphasise controls over reaction conditions, removal of residual reactants or catalysts, and compliance with good manufacturing practice principles to ensure the final substance is suitable for intended use in the food supply. (ChemicalBook

Why It Is Used In Food

Butyl levulinate is incorporated into food products primarily because of its ability to contribute desired sensory characteristics at low use levels. As a flavouring agent or adjuvant, it can enhance or modify the flavour profile of foods without altering nutritional content. The compound’s inclusion in the category of synthetic flavouring substances and adjuvants reflects its role as a technical additive that helps manufacturers achieve consistent and targeted organoleptic effects in complex food matrices. Its use is governed by regulatory provisions that require it to be used in the minimum quantity necessary to achieve its intended effect and in accordance with good manufacturing practices. Because flavouring agents are often needed at trace levels, butyl levulinate is suitable for applications where the goal is to impart subtle sensory nuances, such as sweet, fruity, or caramel notes, without dominating the overall flavour profile.

Adi Example Calculation

Because a specific numeric ADI figure for butyl levulinate is not established in the available regulatory evaluations, illustrative calculations using hypothetical ADI values are not included here. This reflects the fact that this flavouring agent has been assessed by expert committees under criteria that do not assign a numeric ADI when typical exposures are considered to be well below levels associated with adverse effects. In regulatory practice, when ADI values are defined, calculation examples would typically involve multiplying the ADI (expressed in milligrams per kilogram of body weight per day) by a body weight value to estimate total allowable intake. However, for butyl levulinate, reliance on international evaluations that conclude no safety concern at current intake levels obviates the need for specific numeric ADI calculations within this context. (世界卫生组织应用程序

Safety And Health Research

Butyl levulinate’s safety profile as a flavouring substance has been reviewed by international expert bodies tasked with evaluating food additives. JECFA, in its evaluation, concluded that the compound did not raise safety concerns at current anticipated levels of intake when used as a flavouring agent, reflecting a risk assessment framework that considers exposure and toxicological data relevant to flavouring substances. Regulatory science assessments typically focus on endpoints such as genotoxicity, subchronic toxicity, and other standard toxicological parameters to ensure that use at intended levels does not pose undue risk. The absence of numerical acceptable daily intake values in public summaries often reflects the nature of flavouring agent evaluations, where estimated intake from typical usage patterns is substantially below levels associated with adverse effects in available studies. While specific mechanistic or clinical investigations for butyl levulinate may be limited in publicly available literature, its inclusion in regulatory lists and international evaluations reflects a consensus on its safe use under defined conditions. The evaluation by JECFA and regulatory frameworks emphasise exposure management, technical necessity, and adherence to good manufacturing practices. (世界卫生组织应用程序

Regulatory Status Worldwide

In the United States, butyl levulinate is listed under the provision for synthetic flavouring substances and adjuvants in the Code of Federal Regulations at section 172.515, which permits the use of listed synthetic flavouring substances under conditions that they are used in the minimum quantity required to achieve their intended effect and conform to good manufacturing practices. This regulatory reference identifies the framework under which the additive can be used in food products. (电子联邦法规) Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated butyl levulinate as a flavouring agent and, in its evaluations, found it to present no safety concerns at current levels of intake when used as a flavouring agent. This evaluation supports its continued use as a food flavouring ingredient within regulatory systems that recognise JECFA assessments as part of the safety review process. (世界卫生组织应用程序

Taste And Functional Properties

Butyl levulinate’s sensory attributes reflect typical ester characteristics, with reported descriptors including sweet and slightly caramellic notes with fruity undertones, contributing complexity to flavour formulations. These sensory properties make it useful in various flavour blends where balance and nuance are desired. From a functional standpoint, its physical properties, such as moderate solubility in lipophilic environments and slight solubility in water, influence how it behaves in different food systems. Esters like butyl levulinate are generally stable under normal food processing conditions when used at low levels, and their efficacy is linked to both volatility and interaction with other flavour components. Because flavour perception is multifaceted, the inclusion of specific esters like butyl levulinate serves to modulate aroma and taste in concert with other ingredients, helping to achieve targeted sensory endpoints in consumer products. (ChemicalBook

Acceptable Daily Intake Explained

Acceptable Daily Intake (ADI) is a risk assessment metric used by food safety authorities to describe the amount of a substance that can be consumed daily over a lifetime without appreciable health risk, typically expressed relative to body weight. For many flavouring agents, including butyl levulinate, traditional numeric ADI values may not be established because the compounds are intended for use at low concentrations and intake estimates from food are well below levels associated with adverse effects in relevant studies. Regulatory evaluations such as those performed by JECFA consider available toxicological data and anticipated use levels to determine whether there are safety concerns at current levels of intake. In the case of butyl levulinate, JECFA’s conclusion of no safety concern at current intake levels is consistent with a framework where specific ADIs are not numerically defined but safety is supported by expert assessment of exposure and data. Consumers should understand that ADI values are tools used by regulators to manage risk and that the absence of a specific ADI figure for certain flavouring agents reflects regulatory judgment that typical use levels are low and represent minimal risk within approved use conditions. (世界卫生组织应用程序

Comparison With Similar Additives

Butyl levulinate shares functional similarities with other ester-type flavouring substances such as ethyl levulinate or methyl levulinate, which are also used to impart subtle sensory nuances in food formulations. These compounds typically exhibit ester-derived sensory characteristics and are chosen in flavour blends for complementary effects. Compared with short-chain ester flavouring agents like ethyl acetate, butyl levulinate may contribute more complex or rounded sensory notes due to its longer carbon chain and specific functional groups. The choice among different ester flavouring agents depends on the desired flavour profile, volatility, and compatibility with other ingredients. Like other synthetic flavouring substances included in regulatory provisions, butyl levulinate and similar additives are subject to use conditions that emphasise minimal required quantities and adherence to good manufacturing practices, and their regulatory status often reflects international evaluations such as those by JECFA that inform safety considerations. (世界卫生组织应用程序

Common Food Applications Narrative

In the realm of food formulation, butyl levulinate serves as a component of flavouring blends used to achieve specific sensory profiles in a wide range of products. Its application is typically in foods and beverages where nuanced aromatic and taste effects are sought, and at levels dictated by regulatory frameworks and good manufacturing practices. Examples include its use in beverages, confectionery, bakery products, and other processed foods where a subtle enhancement of fruit, caramel, or sweet notes can contribute to the overall flavour experience. As a synthetic flavouring agent, it is not added for nutritive value but for its contribution to the organoleptic characteristics that consumers associate with quality and desirability in food products. Food manufacturers rely on detailed flavour formulation expertise, where components such as butyl levulinate are blended with other flavouring substances to craft complex profiles that meet consumer preferences. Regulatory guidelines ensure these flavouring agents are used responsibly, aligning sensory goals with safety considerations and standards for food additives. (FEMA

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 172.515

EFSA

  • Notes: No specific EFSA regulation or ADI information found

JECFA

  • Year: 1999
  • Notes: JECFA concluded no safety concern at current intake levels without numeric ADI

Sources

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