GLYCERIN, SYNTHETIC

CAS: 977091-53-4 ANTICAKING AGENT OR FREE-FLOW AGENT, DRYING AGENT, EMULSIFIER OR EMULSIFIER SALT, HUMECTANT, MASTICATORY SUBSTANCE, NUTRITIVE SWEETENER, SOLVENT OR VEHICLE, STABILIZER OR THICKENER, TEXTURIZER

GLYCERIN, SYNTHETIC is a manufactured polyol used in foods for moisture retention, texture modification, emulsification, and as a solvent-like ingredient.

What It Is

GLYCERIN, SYNTHETIC is a chemically defined polyhydric alcohol derivative used in food and related products. It is identified by the Chemical Abstracts Service Registry Number 977091-53-4 and appears in regulatory inventories for use as a functional additive. Technically classified across multiple use categories, it can act as an anticaking or free-flow agent, drying agent, emulsifier or emulsifier salt, humectant, masticatory substance, nutritive sweetener, solvent or vehicle, stabilizer or thickener, and texturizer. This reflects its broad set of physical and functional properties when incorporated into formulations designed to influence moisture, texture, cohesion and stability of foods. In regulatory contexts in the United States, GLYCERIN, SYNTHETIC is d in specific sections of Title 21 of the Code of Federal Regulations (CFR) that authorize its presence in or on food under specified conditions, indicating it is addressed as a listed substance with uses and conditions articulated by the U.S. Food and Drug Administration (FDA) in additive listings. The inclusion of this additive in such inventories provides assurance that its identity, composition, and functional classes are recognized by regulators for defined technological purposes in food and food contact materials. Overall, it is a multifunctional ingredient that supports both formulation and end-product sensory attributes without introducing flavors or strong tastes of its own.

How It Is Made

GLYCERIN, SYNTHETIC is manufactured through chemical synthesis rather than extraction from biological fats. While glycerol can occur naturally and is a component of triglycerides found in fats and oils, the synthetic form is prepared by controlled chemical routes designed to yield a high-purity polyol suitable for industrial and food applications. Typically, synthesis methods involve base-catalyzed reactions that produce the glycerol backbone, followed by purification steps such as distillation to achieve a chemically consistent product. Manufacturing processes aim to remove undesired byproducts, impurities and residual reactants to meet food-grade quality requirements. The regulatory listing of an additive like GLYCERIN, SYNTHETIC implies that specifications and purity criteria are defined by regulators or industry monographs, which serve to ensure that the product used in food processing is consistent, free from contaminants at defined limits, and appropriate for its intended use. In commercial settings, synthetic glycerin may be produced to meet compendial standards such as those used in excipients for pharmaceutical and food formulations, although specific compendia for the synthetic food additive form listed under the relevant CFR sections may outline separate criteria. The quality of the additive and adherence to good manufacturing practices influence how consistently the material performs its technological functions in food products, including retaining moisture and contributing to texture. Because the manufacturing process does not rely on animal or plant sources, the synthetic form can provide a consistent baseline of functional behavior across batches, supporting formulators in achieving predictable performance in complex mixtures.

Why It Is Used In Food

GLYCERIN, SYNTHETIC is used in food systems for reasons grounded in functionality and formulation requirements. Its chemical structure, which includes multiple hydroxyl groups, allows it to retain water effectively, making it useful as a humectant that helps foods maintain moisture during storage and processing. This ability is valuable in formulations such as confections, dried fruit preparations, and bakery applications where moisture balance directly influences texture and shelf stability. As an emulsifier or emulsifier salt, it assists in creating and stabilizing mixtures of oil and water, which is critical in products like frostings, sauces or dressings where phase separation would otherwise occur. Its roles as a stabilizer or texturizer further support structural integrity, helping to achieve and maintain desirable mouthfeel and consistency in gels, icings and chewy confections. Additionally, GLYCERIN, SYNTHETIC can act as a nutritive sweetener, providing a mild sweet taste that contributes to flavor profiles without the intensity of sucrose or other high-potency sweeteners. When used as a solvent or vehicle, it helps dissolve or disperse flavorings, colors and other functional ingredients uniformly within a formulation. These combined functions contribute to the widespread use of glycerin-related ingredients in processed foods, allowing manufacturers to tailor product attributes such as softness, chewiness, stability and sweetness. Because it interacts with water and other ingredients without contributing strong flavors, GLYCERIN, SYNTHETIC supports product quality while enabling diverse technological outcomes.

Adi Example Calculation

An illustrative explanation of an acceptable daily intake (ADI) calculation can help readers grasp the concept, even for substances where a numeric ADI is not specified. In general, when a numeric ADI is established, regulators may express it in milligrams of additive per kilogram of body weight per day. To illustrate, suppose a hypothetical additive had an ADI of 10 milligrams per kilogram of body weight per day; a person weighing 70 kilograms would have a theoretical ā€˜allowableā€™ intake of 700 milligrams per day under that ADI. This simple multiplication provides a context for understanding how ADI relates to body size. In the absence of a specified numeric ADI for glycerin-type additives, the illustration underscores that regulators consider typical exposures from authorized food uses, combined with the compoundā€™s properties and metabolism, to fall within safe bounds without identifying a strict numerical limit. It also highlights that ADI is a conservative tool for risk management and not a target for consumption, reinforcing that actual intakes in most diets are typically far below levels associated with any plausible adverse effects.

Safety And Health Research

Regulatory scientific bodies have reviewed glycerol and glycerin-type additives with the aim of ensuring safety at levels encountered in food. The European Food Safety Authority (EFSA) re-evaluated glycerol (E 422) as a food additive and noted that based on the available data, there was no need to establish a numerical acceptable daily intake, pointing to a long history of safe use and lack of significant toxicological concerns at authorized uses. EFSAā€™s scientific opinion reflects consideration of available studies and industry data relevant to safety assessment of glycerol when used as intended in food formulations. Similarly, JECFA evaluations indicate that glycerol has been allocated an INS number 422 and that its specifications and identity criteria have been developed, although specific numeric health-based guidance values are not assigned, consistent with historical evaluations where an ADI was not specified due to the nature of the compound and its metabolic handling. These assessments reflect the function and metabolism of glycerol in human physiology, where glycerol is a common component of fats and an endogenous metabolite. Safety research and regulatory evaluations focus on toxicological endpoints such as genotoxicity, carcinogenicity and reproductive effects, and conclude that at levels used for technological purposes in foods, there is no evidence of safety concerns requiring restrictive limits. Specific numeric guidance values are not commonly set for this additive in regulatory monographs, emphasizing that authorized use must adhere to good manufacturing practice and purity criteria to avoid contaminants that might pose health concerns.

Regulatory Status Worldwide

In the United States, GLYCERIN, SYNTHETIC is listed in the FDAā€™s inventory of substances that appear in Title 21 of the Code of Federal Regulations, indicating it is recognized for use in food-related applications under defined sections. Specifically, the additive is associated with sections 172.866 and 178.3500 of 21 CFR, which correspond to food additive regulations governing certain permitted substances and food contact materials; consult the CFR text for exact conditions of use and limitations. This listing confirms that the additive has been evaluated and included by the FDA for specified uses in foods and food-related materials as reflected in the inventory. Within the European Union, glycerol is authorized as a food additive under the designation E 422 and appears in Annex II and Annex III of Regulation (EC) No 1333/2008 on food additives, with specifications defined in Commission Regulation (EU) No 231/2012. It is permitted at quantum satis, meaning there is no set maximum numerical level provided that use levels adhere to good manufacturing practice and serve a technological function. The UK Food Standards Agency also lists glycerol (E 422) with permitted uses in specific categories. Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) recognizes glycerol under the INS number 422, with specifications available for identity and purity, reflecting its global acceptance and standardized criteria for food additive use. Regulatory frameworks generally focus on identity, purity and conditions of use rather than prescribing a precise allowable daily intake, consistent with long experience of safe use in foods.

Taste And Functional Properties

GLYCERIN, SYNTHETIC is generally characterized by a neutral to mildly sweet taste that does not compete with or overpower other flavor components in a formulation. The sweetness it contributes is considerably less intense than that of regular sugars, which allows it to impart gentle flavor enhancement without dominating the overall taste profile. Functionally, its polyol structure enables it to interact with water and other polar molecules effectively. Its high solubility in water and hydrophilic nature make it valuable where moisture modulation is needed. In humid and dry environments alike, glycerin can help retain moisture within a product, which can prevent hardening, improve mouthfeel and extend shelf life by influencing water activity. Additionally, its relatively high boiling point and thermal stability allow it to survive common processing conditions encountered in baking and confectionery manufacture without significant degradation, although like many polyols, its behavior under heat can influence viscosity and texture dynamically during processing. Because it does not volatilize easily, glycerin supports consistent texture in finished products. In emulsification, it acts by facilitating the dispersion of oil droplets in aqueous phases, aiding in stable mixtures that resist separation. Its texturizing and thickening capabilities further contribute to the sensory attributes of foods, especially where smoothness and cohesive structure are desirable. Collectively, these attributes underpin its widespread technological use across product categories.

Acceptable Daily Intake Explained

The concept of an acceptable daily intake (ADI) represents the amount of a substance that can be consumed daily over a lifetime without appreciable health risk, typically expressed relative to body weight. For substances where regulators conclude that a numerical ADI is not necessary, this generally reflects confidence that the compoundā€™s metabolic pathways and toxicological profile do not indicate risk at levels encountered in food use, provided that identity and purity specifications are met. In the case of glycerol-type additives, scientific evaluations have noted that because glycerol is a naturally occurring compound with established metabolic handling in humans and a history of widespread use in food, a numerical ADI was not specified in certain regulatory assessments. This should not be interpreted as a recommended intake level; rather it indicates that regulators consider the compound to pose low risk when used according to good manufacturing practice and within authorized functional uses. Explaining ADI in lay terms can help readers understand that safety evaluations integrate information about how a compound is processed by the body, what kinds of toxicological data exist, and how routine food use levels relate to possible exposure. Where a numeric ADI is not set, it reflects a conclusion that routine dietary exposures are not expected to raise health concerns when identity, purity and conditions of use specified by regulators are met.

Comparison With Similar Additives

Comparing GLYCERIN, SYNTHETIC to other multifunctional additives helps clarify its role. For example, sorbitol (often labeled as E420) is another polyol used as a humectant and sweetening agent that helps retain moisture and contribute mild sweetness, similar to glycerin-type additives; however, sorbitolā€™s metabolism and sweetness profile differ, leading formulators to choose one over the other based on desired sweetness intensity and processing behavior. Propylene glycol (E1520) serves as a solvent and humectant in foods and beverages, supporting the dissolution of flavors and stabilizing moisture, yet it has distinct regulatory and metabolic considerations that differentiate its use from glycerin-type ingredients. Additionally, polyglycerol esters of fatty acids (E475) function as emulsifiers and texturizers but are larger molecules tailored for specific emulsification performance in high-fat systems. These comparisons underscore that while several additives can achieve overlapping functional ends such as moisture retention or emulsification, each additiveā€™s chemical structure, sensory impact and regulatory status inform its selection by food developers. Understanding the nuanced differences among such additives supports informed formulation decisions that balance functionality, sensory outcomes and compliance with regulatory frameworks.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 172.866 and 178.3500

EFSA

  • Notes: EFSA concluded no need for a numerical ADI in its re evaluation
  • Approved: True
  • E Number: E422
  • Adi Display: ADI not specified by EFSA

JECFA

  • Notes: JECFA has not specified a numeric ADI in available evaluations
  • Ins Number: 422
  • Adi Display: ADI not specified

Sources

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