MANGANESE GLUCONATE

CAS: 6485-39-8 FLAVORING AGENT OR ADJUVANT, FUMIGANT

Manganese gluconate is a manganese salt of gluconic acid used as a nutrient supplement and flavor-related agent in foods under current good manufacturing practice as affirmed in the U.S. Code of Federal Regulations.

What It Is

Manganese gluconate is a chemical compound consisting of manganese bound to gluconate anions and is recognized in food regulation as a substance affirmed as generally recognized as safe (GRAS) for use in food when used in accordance with current good manufacturing practice. It is identified by the Chemical Abstracts Service (CAS) number 6485-39-8 and is described in the U.S. food regulatory code at 21 CFR 184.1452. Manganese gluconate serves as a source of the essential trace element manganese in foods and is sometimes described as a nutrient supplement under food additive regulations. Its inclusion in food ingredient inventories reflects its acceptance as a direct human food ingredient when used appropriately. In regulatory terms, manganese gluconate is permitted based on its safety profile and defined conditions of use under applicable regulations, and it is used in a variety of product categories by manufacturers to provide technological function related to nutrient fortification. It is a slightly pink powder in its hydrated form and may be manufactured as an anhydrous or dihydrate product for food ingredient applications. Within the food industry, substances like manganese gluconate are selected for use because they deliver manganese, an essential mineral that contributes to physiological processes, without imposing specific quantitative limits beyond current good manufacturing practice. Its classification as a flavoring agent or adjuvant and fumigant in the technical function description reflects its categorization in food additive registries rather than its primary use as a flavor enhancer in the sensory sense.

How It Is Made

Manganese gluconate is typically prepared by combining an aqueous solution of manganese carbonate or a related manganese source with gluconic acid under controlled conditions of reaction and subsequently isolating the resulting manganese gluconate compound by crystallization. Depending on the manufacturing conditions, the product may be obtained as an anhydrous solid or in a hydrated form containing water of crystallization. The resulting crystalline powder is dried and processed to meet food-grade specifications, including purity criteria consistent with its intended use as a nutrient source in human foods. Reference standards, such as those maintained by pharmacopoeias like the United States Pharmacopeia, specify assay limits to ensure that the manufactured product contains a defined amount of manganese gluconate relative to impurities or residual reactants. Manufacturers of manganese gluconate for food applications implement quality control measures to ensure that the material meets appropriate purity, identity, and safety specifications. These may include tests for heavy metals, residual solvents, microbial contamination, and other quality attributes relevant to food-grade materials. The production and handling of manganese gluconate materials also follow good manufacturing practices to minimize contamination and ensure consistent product quality.

Why It Is Used In Food

Manganese gluconate is used in food primarily as a source of the essential trace element manganese, which plays a role in normal metabolic processes. As a food ingredient, it may be added to products to fortify them with manganese in a form that is compatible with food processing and formulation. In regulatory language, its designation under 21 CFR 184.1452 describes it as a nutrient supplement when used in foods, including baked goods, nonalcoholic beverages, dairy analogs, meat and poultry products, and certain other categories when added at levels consistent with current good manufacturing practice. The inclusion of manganese gluconate in such products allows manufacturers to provide manganese in a form that can be readily incorporated and distributed within diverse food matrices. The rationale for using manganese gluconate versus other manganese sources may include considerations of solubility, stability, and formulation compatibility. As a gluconate salt, it is generally more soluble in water than some other manganese salts, facilitating its addition to beverage systems or aqueous food formulations. Its use as a flavoring agent or adjuvant and fumigant designation reflects registry classification rather than a primary sensory role, and in practice it is selected for its nutrient delivery properties.

Adi Example Calculation

Illustrative calculation of total manganese intake is provided here solely for understanding how intake estimates might be considered in a regulatory context. For example, if a hypothetical adult weighing 70 kg consumed a diet containing manganese from natural food sources and fortified products, and the total manganese intake from these combined sources approximated a figure such as 8 mg/day, dividing that intake by body weight (8 mg/day divided by 70 kg) would yield approximately 0.11 mg/kg body weight per day. This calculation is illustrative and not a regulatory requirement for manganese gluconate specifically. Because regulatory bodies like EFSA have focused on safe level of intake rather than specific numeric ADI values tied to individual compounds, calculations such as this are best used to contextualize overall manganese exposure relative to body weight rather than to imply a recommended intake for any particular food additive. The safety assessment of manganese gluconate as a food ingredient under current good manufacturing practice reflects its acceptability at levels consistent with its intended nutrient delivery role without defined numeric limits.

Safety And Health Research

Safety evaluations for substances like manganese gluconate consider both the properties of the compound and the essential role of manganese as a trace element in the diet. The U.S. Food and Drug Administration’s affirmation of manganese gluconate as GRAS under current good manufacturing practice indicates that, based on the available evidence and history of safe use under specified conditions, its addition to foods as a nutrient supplement is not expected to pose safety concerns when used properly according to regulatory criteria. Independent scientific reviews of manganese intake emphasize that manganese is an essential nutrient required for normal metabolic functioning, including enzyme activation, but that excessive intake from all sources could potentially lead to adverse effects. For example, EFSA has reviewed evidence on tolerable upper intake levels for manganese and concluded that data are insufficient to define a specific upper limit, and instead provided safe level of intake estimates for total manganese consumption, with a safe level of intake of 8 mg/day for adults including pregnant and lactating women and lower ranges for other population groups based on overall dietary exposure. These assessments help contextualize manganese intake from all dietary sources rather than a specific compound such as manganese gluconate. While specific toxicological data on manganese gluconate itself may be limited, regulators consider the total manganese contribution from fortified foods in the context of overall dietary exposures. Evaluations of other manganese compounds in animal nutrition indicate that manganese compounds can be safely used as nutrient sources provided authorised limits are respected, although these also highlight potential occupational hazards upon inhalation exposure to dust in industrial settings. Safety considerations in finished food applications focus on ensuring that manganese fortification levels remain consistent with nutritional needs and do not result in excessive total intake.

Regulatory Status Worldwide

In the United States, manganese gluconate is affirmed as generally recognized as safe (GRAS) for use in food when used in accordance with current good manufacturing practice as specified in 21 CFR 184.1452. This regulation identifies conditions under which the ingredient may be used as a nutrient supplement in various food categories without numerical usage limits beyond good manufacturing practice. The U.S. Code of Federal Regulations section affirms its status and enumerates the food categories where its use is recognized. In other jurisdictions, formal additive listings such as E numbers in the European Union may not specifically include manganese gluconate, and its use would be subject to the applicable regional regulations for nutrient sources and food ingredients. EFSA maintains an authorised food additive database for the EU, but there is no indication of a distinct E number for manganese gluconate. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) maintains food additive specifications databases, although specific additive specifications for manganese gluconate may not be present in current online listings. Availability of additive specifications or a specific E number for manganese gluconate in the EU would require separate confirmation from regional regulatory databases. In summary, its regulatory acceptance as a food ingredient in the U.S. is well established under 21 CFR 184.1452, while in other regions its status as a nutrient source must be confirmed with local food additive regulatory frameworks. Use outside the United States should be undertaken in accordance with applicable regional food laws.

Taste And Functional Properties

Manganese gluconate itself imparts minimal taste characteristics at the concentrations typically used for fortification in foods, and is not generally recognized as contributing a distinct flavor profile in finished products. Its primary functional attribute is to provide a bioavailable source of manganese, and as a gluconate salt it dissolves fairly readily in water, which can assist in uniform distribution when added to aqueous-based foods such as beverages or batters. Functional properties of manganese gluconate in food systems include its solubility behavior and its interaction with other ingredients. Because of the gluconate anion, it is more soluble in water than some other manganese salts, which can be advantageous for applications requiring homogeneous mixing. Additionally, its stability under typical food processing conditions such as moderate heat and pH ranges encountered in baking or beverage production supports its use in a variety of food categories. While manganese itself does not contribute appreciable flavor, formulations containing manganese gluconate need to ensure that the ingredient does not impact product stability or organoleptic properties. At typical fortified levels consistent with current good manufacturing practice, the presence of manganese gluconate does not significantly alter the sensory perception of foods, and it functions primarily to deliver manganese in a chemically compatible form.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) is a regulatory concept used to indicate a level of daily exposure to a substance that is considered without appreciable risk over a lifetime, typically expressed in milligrams of substance per kilogram of body weight. For food additives, ADIs are established by expert bodies such as JECFA or EFSA based on toxicological data. For manganese gluconate specifically, regulatory frameworks like the U.S. Code of Federal Regulations do not establish a numeric ADI, but rather affirm its safety when used under current good manufacturing practice. Independent scientific bodies have evaluated overall manganese intake from all dietary sources rather than a specific additive form. EFSA’s evaluations have indicated that data are insufficient to define traditional tolerable upper intake levels for manganese, but have provided safe level of intake estimates for total manganese exposure from all sources. These reference levels are used to ensure that combined dietary intake from natural and fortified food sources remains within a range that is not expected to pose safety concerns for consumers. It is important to understand that ADIs or safe level of intake values pertain to total exposure to an element or compound class rather than to the presence of a specific salt such as manganese gluconate. When used appropriately in food fortification, manganese gluconate contributes manganese to the diet as part of total dietary intake considerations.

Comparison With Similar Additives

Manganese gluconate can be compared with other mineral salts used for nutrient fortification in foods, such as zinc gluconate or calcium gluconate, which are also salts of gluconic acid with essential mineral cations. These gluconate salts share functional attributes such as water solubility and the ability to deliver a specific mineral nutrient without appreciable impact on taste at typical fortification levels. Compared with basic mineral salts like manganese sulfate or manganese chloride, manganese gluconate’s gluconate anion often improves solubility and formulation compatibility in aqueous food systems, which can facilitate uniform distribution, although taste and stability must still be considered. Other gluconate salts, such as magnesium gluconate or zinc gluconate, serve similar roles in delivering their respective mineral nutrients in foods and supplements. The choice among these salts depends on formulation requirements, absorption characteristics, and regulatory acceptance. From a regulatory perspective, many mineral salts share the characteristic of being affirmed as safe or listed as nutrient sources under current good manufacturing practice without specific numerical limits, relying on overall dietary exposure assessments and nutritional context rather than strictly defined ADI values for each specific compound.

Common Food Applications Narrative

Manganese gluconate is applied in a range of food products where nutrient fortification or trace element supplementation is desired as part of formulating nutritionally balanced foods. For example, manufacturers may choose to add manganese gluconate to baked goods to deliver manganese without affecting texture or flavor, and its water solubility can make it suitable for addition to beverage products where uniform distribution is important. In dairy analogs and related products, the addition of a manganese source such as manganese gluconate supports the creation of products that provide nutritional value comparable to traditional dairy foods. In meat, fish, and poultry formulations, trace mineral fortification can be part of delivering balanced nutrient profiles, particularly when natural levels of manganese vary with raw material sources. Across these applications, the use of manganese gluconate is guided by current good manufacturing practice rather than fixed quantitative limits, reflecting its role as a nutrient supplement when used appropriately. Because it is recognized under the U.S. federal regulation as GRAS for its intended uses when consumed at levels consistent with good manufacturing practice, manganese gluconate may appear in food ingredient lists on packaging where fortification is a marketing or nutritional strategy. Its inclusion helps producers meet nutritional targets for manganese without introducing undesirable sensory impacts, and supports product positioning in markets where trace mineral fortification is valued by consumers.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 184.1452

EFSA

  • Notes: No specific E number found for manganese gluconate in EU food additive lists

JECFA

  • Notes: JECFA specifications database does not list manganese gluconate specifically

Sources

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