MONO- AND DIGLYCERIDES, ETHOXYLATED

CAS: 61163-33-5 DOUGH STRENGTHENER, EMULSIFIER OR EMULSIFIER SALT, LEAVENING AGENT

MONO- AND DIGLYCERIDES, ETHOXYLATED is a food additive used primarily as an emulsifier and dough strengthener permitted under U.S. regulation 21 CFR 172.834 for specific food applications.

What It Is

MONO- AND DIGLYCERIDES, ETHOXYLATED is a specialized food additive composed of mono- and diglycerides of fatty acids that have been reacted with ethylene oxide to introduce ethoxy groups, increasing their hydrophilicity and functional performance in complex food systems. The chemical is identified by CAS Number 61163-33-5 and has a series of alternative names that reflect its structure and ethoxylation level, such as PEG-20 mono- and diglycerides ethoxylated, polyglycerate 60, and polyoxyethylene (20) mono- and diglycerides. As indicated by its designation and technical function, this ingredient is used primarily as a dough strengthener and emulsifier, contributing to the mixing, texture, and stability of certain processed foods. The ethoxylated modification differentiates this ingredient from conventional mono- and diglycerides by enhancing water compatibility and emulsification properties without substantially altering flavor characteristics. This additive functions as an emulsifier or emulsifier salt, assisting in the uniform dispersion of water and fat phases in food formulations, and can act as a leavening agent in specific bakery applications. Its inclusion in formulations is designed to improve texture and processing performance, particularly in products where fat and water need to be combined stably. Regulatory inventories in the United States list this substance specifically under food additive regulations, reflecting its recognized role in permitted uses. MONO- AND DIGLYCERIDES, ETHOXYLATED should not be confused with unmodified mono- and diglycerides: the ethoxylated form has distinct physicochemical properties because of the attached ethylene oxide chains and is typically used for its enhanced emulsification and functional behavior. The ingredient’s classification as a dough strengthener and emulsifier underscores its targeted use in commercial food production rather than as a direct source of nutrition.

How It Is Made

The manufacture of MONO- AND DIGLYCERIDES, ETHOXYLATED involves modifying mono- and diglycerides of fatty acids with ethylene oxide under controlled reaction conditions to introduce ethoxylate chains. While specific industrial processes can vary among manufacturers, the general approach begins with edible fats or oils that are partially glycerolyzed to yield mono- and diglycerides of mixed fatty acids, typically derived from sources such as palm, stearic, and palmitic rich fats. These partial glycerides are then reacted with a measured amount of ethylene oxide, often at a ratio that yields approximately twenty moles of ethylene oxide per mole of mono- and diglycerides. The ethoxylation step is conducted under conditions that promote the formation of polyoxyethylene chains attached to the glyceride backbone, increasing the hydrophilic character of the resulting molecule. Following the ethoxylation reaction, the product is typically purified and adjusted to meet defined quality specifications that ensure consistency and performance in food applications. Specifications may include criteria such as acid number, saponification number, and oxyethylene content to verify that the product meets regulatory and functional requirements. Because the process involves reactive chemistry with ethylene oxide—a compound that requires careful handling—the manufacturing environment adheres to industrial safety standards and engineering controls designed to manage exposure. The resulting additive is a pale to slightly yellow liquid or semigel that combines hydrophilic and lipophilic properties, making it suitable for stabilizing emulsions and improving the textural attributes of baked goods and other formulated foods. Although individual manufacturers may optimize aspects of this process for efficiency or regional raw material availability, the overarching principle remains the incorporation of ethoxylated groups onto a glyceride backbone to confer desirable functional traits in food systems.

Why It Is Used In Food

MONO- AND DIGLYCERIDES, ETHOXYLATED is used in food formulations primarily for its ability to improve the interaction between water and fat, which are naturally immiscible. In many commercial foods—such as baked goods, icings, frozen desserts, and beverage emulsions—achieving a stable mixture of water and fat is essential for texture, volume, and overall product quality. The ethoxylated groups increase the hydrophilic character of the mono- and diglyceride molecules, enhancing their emulsifying capacity beyond that of unmodified glycerides. In bakery applications, this ingredient can help strengthen dough structure, improve gas retention during fermentation and baking, and contribute to uniform crumb texture. As an emulsifier, it supports the formation and stabilization of fine fat droplets in water-rich systems, leading to consistent mouthfeel and appearance in products like icings and whipped toppings. In frozen desserts, the additive can influence overrun—the amount of air incorporated—and contribute to uniform freezing properties, which affects smoothness and scoopability. By facilitating better integration of fats and aqueous phases, the ingredient helps formulators tailor the sensory and functional attributes of processed foods to meet consumer expectations and manufacturing constraints. The targeted use of MONO- AND DIGLYCERIDES, ETHOXYLATED addresses key formulation challenges in foods where water and fat phases must be combined and stabilized reliably. Its inclusion is intended to support technology-driven objectives such as improved processing efficiency, enhanced texture, and consistent product performance across production batches. Because its effects relate to the physical behavior of food components rather than to flavor or nutrition, formulators choose this additive for its technical functionality in specific categories of food products.

Adi Example Calculation

To illustrate how acceptable daily intake might be conceptualized, consider a hypothetical illustrative example for a food additive with a defined numeric ADI (note that this is illustrative and not a regulatory prescription for this ingredient). Suppose a regulatory authority had established an ADI of X mg per kilogram of body weight per day for a given additive. For a person weighing Y kilograms, the maximum amount that could be consumed daily without exceeding the ADI would be calculated by multiplying the ADI value by the body weight. For instance, if an ADI were 10 mg/kg and an individual weighed 60 kg, the calculation would suggest that up to 600 mg of the additive could be consumed daily without exceeding the acceptable intake threshold. It is important to emphasize that such examples are illustrative of the concept of ADI and not recommendations for use or consumption of a specific additive. In the case of MONO- AND DIGLYCERIDES, ETHOXYLATED, regulatory use limitations defined for specific food categories serve to constrain potential exposure rather than a single numeric ADI, and actual intake would depend on consumption patterns of foods containing the additive.

Safety And Health Research

Safety evaluations for food additives, including emulsifiers and dough conditioners, generally focus on toxicological endpoints such as acute toxicity, subchronic and chronic exposure, and potential effects on organ systems. Historical evaluations of conventional mono- and diglycerides as a class have concluded that these substances are readily metabolized in the gastrointestinal tract and do not exhibit significant acute toxic effects at practical intake levels. Expert committee reports on mono- and diglycerides derived from fatty acids indicate that no harmful effects have been specifically associated with these compounds in controlled studies, and that estimates of acceptable daily intake for mono- and diglycerides were not limited in evaluations conducted by international bodies focused on food additive safety. Such evaluations reflect extensive experience with glycerides as natural constituents of dietary fats and as intentional additives in food. For ethoxylated derivatives such as MONO- AND DIGLYCERIDES, ETHOXYLATED, the safety profile is generally inferred from functional similarity and metabolic considerations, acknowledging that the ethoxylation process alters solubility and interaction with water and fat phases but does not introduce structural elements associated with intrinsic toxicity at permitted use levels. Regulatory acceptance under U.S. food additive regulations implies evaluation of available safety data and establishment of use conditions that protect public health. The absence of specific adverse physiological effects directly tied to ethoxylated mono- and diglycerides in authoritative safety reviews supports their status as technologically functional ingredients rather than agents associated with health risk when used in accordance with regulatory allowances. Scientific assessments of similar emulsifiers often consider factors such as digestibility, absorption, and breakdown in the gastrointestinal tract, as well as systemic exposure, to ensure that formulation use does not pose undue risk. Overall, safety research emphasizes conservative assessment and regulatory oversight to ensure that food additives perform their intended technological functions without compromising consumer safety.

Regulatory Status Worldwide

In the United States, MONO- AND DIGLYCERIDES, ETHOXYLATED is explicitly listed as a permitted food additive under Title 21 of the Code of Federal Regulations, section 172.834, which outlines conditions for its safe use in specified food categories such as bakery products, cakes, icings, frozen desserts, and certain emulsified beverage substitutes. This regulatory status reflects an assessment by the U.S. Food and Drug Administration that the additive can be used safely when applied in accordance with defined use limitations and product categories. The eCFR citation provides the formal legal basis for its inclusion in food formulations under regulated conditions. U.S. inventory listings further identify this substance by CAS number and technical function in regulatory databases that track food substances permitted for direct addition. At the international level, authoritative regulatory databases maintained by organizations such as the FAO and WHO include searchable compendia of food additive specifications and evaluations by expert committees. While mono- and diglycerides (non-ethoxylated) have been evaluated for acceptable daily intake status in historical JECFA assessments, specific entries for the ethoxylated form in global additive compendia are less readily identified in public JECFA search results. Nonetheless, the U.S. regulatory framework provides clear conditions under which this ingredient may be used and establishes its role within permitted food categories. EU regulatory databases and other jurisdictions may have analogous listings or evaluations, though such details would need to be identified in official regional additive regulations to confirm equivalency in permitted uses. In all cases, regulatory approval is typically contingent on adherence to prescribed use levels and specific product categories as defined by the relevant food safety authority.

Taste And Functional Properties

MONO- AND DIGLYCERIDES, ETHOXYLATED typically presents as a pale to slightly yellow oily liquid or semigel with minimal intrinsic flavor, allowing it to function in food systems without contributing off-tastes when used at applied levels. Its primary sensory characteristic is functional rather than gustatory, meaning that its contribution to food is related to texture, stability, and uniformity rather than flavor enhancement. The ability of this ethoxylated glyceride to interact with both water and fat phases enables it to support stable dispersion of fat droplets in emulsions, which can influence perceived creaminess, mouthfeel, and consistency in finished products. From a functional perspective, the additive’s ethoxylated chains enhance water compatibility relative to non-ethoxylated mono- and diglycerides, which contributes to improved emulsification capacity. It can help maintain stable fat-in-water systems under varying processing conditions such as mixing, heating, and cooling. In bakery systems, the ingredient aids in forming and stabilizing dough matrices that retain gas during fermentation and baking, resulting in improved volume and crumb structure. In frozen desserts and aerated toppings, its contribution to overrun and freeze-thaw stability affects the smoothness and resistance to ice crystal growth, which are key determinants of consumer acceptability. In addition to emulsification, the additive’s impact on viscosity and dispersion can influence the texture and spreadability of products such as icings. Because the ingredient typically performs its role at low concentrations relative to the overall formulation, it does not markedly alter taste profiles but supports the desired physical characteristics of the finished food. Its stability under typical processing temperatures and pH ranges encountered in bakery and dessert products further underscores its utility as a versatile functional ingredient in complex food matrices.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) is a concept used by food safety authorities to describe the amount of a food additive that can be consumed daily over a lifetime without appreciable health risk. The ADI is typically expressed relative to body weight and is derived from toxicological studies that identify doses causing no observed adverse effects in animal models, followed by application of safety factors to account for uncertainties in extrapolating to human exposure. For some classes of additives, such as conventional mono- and diglycerides of fatty acids, historical evaluations by expert committees have indicated that an ADI need not be numerically limited because these substances are metabolized naturally and do not exhibit adverse effects at relevant intake levels. In such cases, the ADI may be described as "not limited," reflecting a body of evidence supporting safety in typical food uses. For MONO- AND DIGLYCERIDES, ETHOXYLATED specifically, regulatory frameworks like that in the United States do not assign a numeric ADI in the same manner as some international evaluations but instead define conditions of safe use, including maximum inclusion levels in specified food categories. These use limitations effectively constrain exposure in the diet so that intake remains within ranges deemed safe based on available data and functional considerations. Understanding ADI helps consumers and formulators appreciate that safety assessments account for both the quantity of additive present in foods and the expected frequency of consumption, with regulatory oversight ensuring that authorized use supports public health protection.

Comparison With Similar Additives

MONO- AND DIGLYCERIDES, ETHOXYLATED can be compared with related emulsifiers such as conventional mono- and diglycerides of fatty acids, and sucrose esters of fatty acids, in terms of functional behavior and application niches. Conventional mono- and diglycerides, which are not ethoxylated, serve as emulsifiers and dough conditioners in a range of bakery products and other formulated foods. While they improve water-fat interactions, their hydrophilic-lipophilic balance (HLB) may differ from ethoxylated derivatives, making them more suitable in systems where less intense water compatibility is needed. MONO- AND DIGLYCERIDES, ETHOXYLATED, by virtue of its ethoxylate chains, tends to exhibit greater affinity for aqueous phases, which can enhance emulsification in products where fine water dispersion is critical. Another related class, sucrose esters of fatty acids, represents a group of nonionic emulsifiers with distinct HLB values that formulators choose for specialty applications such as low-fat spreads and beverage emulsions. These sucrose esters often provide strong emulsifying capacity but may be selected based on desired sensory or nutritional considerations. Compared to both mono- and diglycerides and sucrose esters, ethoxylated glycerides like MONO- AND DIGLYCERIDES, ETHOXYLATED occupy a functional space where enhanced water compatibility and stabilization of complex emulsions are required. Each class has unique physicochemical traits that make it preferable for specific food systems, guiding ingredient selection based on texture, processing conditions, and product goals.

Common Food Applications Narrative

MONO- AND DIGLYCERIDES, ETHOXYLATED is incorporated by food scientists and ingredient technologists into a variety of processed foods that rely on stable mixtures of water and fat for desirable texture and structure. In yeast-leavened bakery products, the additive acts as both a dough strengthener and emulsifier, supporting uniform gas cell distribution and consistent crumb quality across production runs in commercial bakeries. Its role in aiding gas retention and dough handling can contribute to loaf volume and texture, which are important sensory attributes for consumers. In cake formulations and cake mixes, MONO- AND DIGLYCERIDES, ETHOXYLATED assists in blending fats and aqueous components, leading to smooth batters and evenly baked goods with uniform crumb. Its emulsification properties also make it suitable for whipped vegetable oil toppings and topping mixes, where fine air incorporation and stable foam structure are key to product performance. Frozen desserts benefit from the additive’s ability to help control overrun and contribute to a smooth mouthfeel that resists ice crystal formation during storage and handling. In icings and icing mixes, the ingredient supports consistent spreadability and surface sheen, enhancing appearance and texture without imparting strong flavor notes. Beverage emulsions that substitute edible fats for dairy cream in coffee or similar applications can also utilize this additive to maintain a stable fat-in-water dispersion, which affects visual uniformity and sensory consistency. Across these applications, formulators select MONO- AND DIGLYCERIDES, ETHOXYLATED for its capacity to address specific functional challenges associated with water-fat interactions, particularly in products where texture, stability, and process performance are priorities. Its inclusion is a reflection of targeted formulation strategies rather than broad nutritional impact, aligning with the needs of modern food systems to deliver consistent quality in diverse product categories.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 172.834

EFSA

  • Notes: EFSA-specific evaluation not identified in authoritative sources

JECFA

  • Notes: Specific JECFA entry for the ethoxylated form was not identified in authoritative JECFA database search

Sources

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