IRON-CHOLINE CITRATE COMPLEX

CAS: 1336-80-7 NUTRIENT SUPPLEMENT

IRON-CHOLINE CITRATE COMPLEX is a chelated iron nutrient supplement used as a source of iron in foods for special dietary use under U.S. regulation. It is composed of iron bound with choline and citrate, forming a complex that enhances iron solubility.

What It Is

IRON-CHOLINE CITRATE COMPLEX is a defined chemical compound used as a nutrient supplement specifically to provide iron in fortified foods and products formulated for special dietary use. It consists of iron, choline, and citrate combined to form a chelate complex that serves as a more soluble and bioavailable source of iron. The CAS registry number for this compound is 1336-80-7, which uniquely identifies the substance in scientific and regulatory databases. The structure of the complex enables the ferric iron component to be stabilized by citrate and choline ligands, which can affect both its solubility and functional properties when incorporated into food matrices. Iron is an essential trace mineral required for oxygen transport, cellular respiration, and numerous enzymatic processes in living organisms. The choline component in the complex is itself an essential nutrient involved in cell membrane structure and neurotransmitter synthesis. However, the role of IRON-CHOLINE CITRATE COMPLEX in food relates primarily to its function as a source of iron rather than as a choline supplement. The citrate portion serves to chelate and stabilize the iron in solution, improving its utility in diverse food formulations. As a nutrient supplement, this compound has a clear technological purpose: to contribute iron content where native levels may be insufficient for the intended nutritional profile of the product. It is recognized in regulatory listings as permitted for use in foods for special dietary use in the U.S. under certain conditions, reflecting regulatory evaluation of its safety and efficacy as an iron source. Current international regulatory listings such as those maintained by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA) do not provide specific acceptable daily intake values or E numbers for this specific complex, indicating a focus on its functional use as a nutrient source rather than as a general additive category. Safety data and usage conditions are typically aligned with its intended purpose as an iron nutrient and the broader safety considerations for iron intake from fortified foods.

How It Is Made

The production of IRON-CHOLINE CITRATE COMPLEX involves the controlled chemical reaction of ferric hydroxide with choline and citric acid to form a stable chelate complex. This synthesis process results from the approximately equimolar reaction of the three components, with ferric iron being the central metal ion complexed by citrate and choline ligands. The process typically occurs in aqueous solution and is controlled to maximize yield and stability of the resulting complex. In commercial manufacturing, purification steps may be applied to ensure that the final product meets food-grade quality specifications. These specifications may include limits on residual reagents, heavy metals, solvent residues, and other impurities to comply with regulatory criteria for use in foods intended for human consumption. The chelation of iron by citrate and choline serves to enhance the solubility and stability of iron in the final product. Iron in its ferric form (Fe3+) can be poorly soluble and difficult to incorporate in certain food systems without chelation or complexation. The citrate ligand, with multiple carboxylate groups, coordinates to the iron ion, while the choline moiety provides additional solubility and compatibility with biological and food matrices. The manufacturing process typically adheres to good manufacturing practices (GMP) to ensure consistency and safety. Purity requirements and analytical verification methods are applied to verify that the product conforms to established identity, strength, and composition criteria. In the context of food-grade additives, the manufacturing process and quality controls are critical to ensure that the additive performs as intended without introducing contaminants. While detailed proprietary methods may vary among manufacturers, the overarching approach involves controlled synthesis under conditions that favor the formation of the target chelate complex. Quality assurance testing may include spectroscopic verification of the complex, assays of iron content, and checks for microbial and chemical purity. Given its role as a nutrient supplement, this compound is processed under food-safe conditions and subject to regulatory oversight that ensures appropriate specifications for use in food.

Why It Is Used In Food

IRON-CHOLINE CITRATE COMPLEX is used in food primarily to address iron deficiency through fortification of products targeted to populations with increased nutritional needs. Iron deficiency is a common nutritional concern globally, particularly among individuals with higher requirements, including women of childbearing age, children, and certain clinical populations. The inclusion of iron in food products, when done in regulated and controlled ways, increases the iron content of the diet and contributes to meeting dietary reference intakes. The chelate complex form is selected for its improved solubility compared to some other forms of iron, which can facilitate its incorporation into aqueous and processed food systems without precipitating or adversely affecting texture. This compound is permitted in foods for special dietary uses under U.S. food additive regulations, reflecting its recognized function as a nutrient supplement when formulated according to prescribed conditions. Iron is an essential component of hemoglobin and numerous cellular enzymes, and its intake from fortified foods can help prevent iron-deficiency anemia when dietary intake from natural sources is inadequate. In fortified foods, this form of iron is chosen for compatibility with product formulation, stability during processing, and acceptable sensory characteristics when used at nutritionally relevant levels. The specific regulatory listing under 21 CFR 172.370 acknowledges that the compound serves as a source of iron and may be safely used in special dietary foods when produced and labeled according to regulatory requirements. Manufacturers and nutrition professionals consider the technological function of adding an iron source when addressing population-level deficiencies or formulating products intended for individuals with increased nutritional needs. Using forms of iron that are soluble, stable, and bioavailable supports the design of effective nutritional interventions. While the choice of iron compound can influence factors such as taste, stability, and cost, the chelate complex form represented by IRON-CHOLINE CITRATE COMPLEX combines desirable technical attributes with a long-standing regulatory acceptance for targeted uses in foods.

Adi Example Calculation

To illustrate how intake from a fortified food could contribute to overall iron consumption, consider a hypothetical fortified beverage that contains a specified amount of elemental iron from IRON-CHOLINE CITRATE COMPLEX. Suppose the product provides 5 milligrams of elemental iron per serving from this additive. If an individual consumes two servings per day, their intake from this fortified source would be 10 milligrams of iron. This calculation is illustrative only and is not a recommendation or regulatory limit. It demonstrates how nutrient intake from fortified foods adds to total dietary iron, which includes iron naturally present in foods and from other fortified products. Because iron requirements vary by age, sex, and physiological status, guidance on total daily iron intake is typically provided by nutrition authorities rather than being tied to a specific additive. For example, dietary reference intakes published by health organizations indicate recommended levels of iron intake for different populations. The purpose of this example calculation is to show how to assess contribution from fortified products relative to overall diet. Nutrient intakes from fortified foods should be considered within the context of total dietary intake and regulatory guidelines to ensure adequacy without excessive intake.

Safety And Health Research

Safety evaluation of IRON-CHOLINE CITRATE COMPLEX centers on its role as a source of iron, which is an essential trace mineral necessary for hemoglobin function and other physiological processes. Regulatory assessments focus on ensuring that the compound can be safely consumed at levels consistent with intended nutritional use without introducing unacceptable risks. Iron compounds, including chelated forms, have been studied extensively in the context of dietary fortification, with considerations for bioavailability and potential adverse effects associated with excessive intake. Standard toxicological endpoints evaluated by regulators typically include acute toxicity, repeated-dose studies, and assessments of nutrient bioavailability, with an emphasis on ensuring that the compound does not introduce specific hazards beyond those inherent to iron itself. Regulatory listings such as the U.S. CFR section for this complex indicate that, under controlled conditions and intended uses, the compound is considered safe as a source of iron in foods for special dietary use. Broader scientific literature on iron fortification underscores that iron bioavailability and tolerability can vary by compound and formulation, but the chelated nature of this complex aims to improve solubility and reduce interactions that might otherwise limit absorption. Extensive safety assessments of mineral fortificants often consider potential gastrointestinal effects, interactions with other nutrients, and the risk of excessive iron intake. However, specific studies on this precise complex in humans were not identified in the regulatory sources searched. Regulatory bodies like EFSA have evaluated other iron compounds as nutrient sources but have not provided evaluations specific to this complex in the public domain at this time.

Regulatory Status Worldwide

In the United States, IRON-CHOLINE CITRATE COMPLEX is listed in the Code of Federal Regulations as an approved food additive for use as a source of iron in foods for special dietary use. Under 21 CFR 172.370, the regulation states that iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in these foods. This regulatory allowance reflects evaluation by the U.S. Food and Drug Administration of the compound's safety for its intended purpose when produced and labeled according to prescribed conditions. No specific maximum use level is provided in the CFR section itself, but the listing signifies that this additive is permitted under U.S. food additive regulations for targeted nutritional uses. Information on the status of this specific complex in the European Union under EFSA or in the list of permitted food additives with assigned E numbers was not found in the regulatory sources evaluated. EFSA maintains a comprehensive process for authorisation of food additives and re-evaluation of those previously permitted, including nutrient sources, but no specific entry or E number for IRON-CHOLINE CITRATE COMPLEX was identified in publicly available regulatory documents at the time of this review. The absence of an E number or explicit EU authorisation in the sources searched suggests that, within the EU, its permitted use may be subject to separate approval processes or national regulatory frameworks. Similarly, there was no explicit listing found in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) database during this search for this specific complex. Regulatory frameworks outside the U.S. may treat iron sources under broader nutrient source categories without assigning a unique additive number.

Taste And Functional Properties

IRON-CHOLINE CITRATE COMPLEX, like many chelated mineral complexes, has a mild, slightly metallic taste characteristic of iron compounds. However, when formulated appropriately in food systems, sensory impacts can be minimized to avoid imparting strong off-notes or bitterness. The citrate and choline moieties help stabilize the iron ion in solution, which can reduce the likelihood of strong metallic flavor compared to less soluble or non-chelated iron salts. Taste interactions depend on formulation, pH, and the presence of other ingredients; for example, acidic environments can influence the perception of metallic notes and the solubility of the complex. Functionally, the complex is valued for its improved solubility relative to some inorganic iron sources, which supports its use in beverages, liquid nutritional products, and other aqueous food applications. Solubility is a key factor when incorporating iron into clear or lightly colored products where precipitation or cloudiness would be undesirable. The citrate component, as a chelating agent, enhances iron dissolution and can help maintain iron in a soluble form during processing and storage. The choline component also contributes to the overall stability and solubility profile, aligning with formulation needs. In terms of stability, the complex can tolerate typical food processing conditions such as mixing, mild heating, and pH adjustments within normal ranges for fortified foods. However, extreme thermal processing or highly alkaline conditions may affect stability and should be evaluated during formulation development. The functional behavior of the complex in various food matrices should be assessed through appropriate product testing to ensure it meets both nutritional and sensory objectives. Overall, the complex provides a balance of functional attributes that support its role as a nutrient supplement in fortified foods with minimal negative impacts on taste and product quality.

Acceptable Daily Intake Explained

An Acceptable Daily Intake (ADI) is an estimate of the amount of a substance that can be consumed daily over a lifetime without appreciable risk of adverse health effects. For many nutrient sources, including iron compounds, an ADI may not always be explicitly established because the nutrient itself is required in the diet and intake recommendations are derived from dietary reference values rather than toxicological limits. In regulatory contexts, ADIs are more commonly assigned to additives where there is potential for overexposure relative to normal physiological needs. In the case of IRON-CHOLINE CITRATE COMPLEX, regulatory listings focus on its permitted use and conditions rather than a specific ADI value. The U.S. food additive regulation recognises its safety as a nutrient source for special dietary use, but does not specify a numeric ADI in the regulatory text. Where numeric intake guidance exists for iron itself, those values are typically expressed in terms of recommended dietary allowances or tolerable upper intake levels for iron, which consider factors such as age and life stage. Because IRON-CHOLINE CITRATE COMPLEX serves as a source of iron, understanding overall iron intake from all dietary sources is important to avoid both deficiency and excessive intake. Excess iron intake can cause adverse effects in susceptible individuals, and regulatory frameworks often set limits on fortification levels accordingly. However, specific numeric intake limits tied directly to this complex were not identified in the authoritative sources reviewed. As a nutrient supplement additive, its use is managed through regulatory permissions and good manufacturing practices to ensure that the levels included in fortified foods align with broader nutritional guidance.

Comparison With Similar Additives

IRON-CHOLINE CITRATE COMPLEX can be compared with other iron fortificants used in food and beverage applications. One common comparison is with ferrous sulfate, a widely used iron salt in fortification programs. Ferrous sulfate provides a high level of elemental iron and is cost-effective, but it can have lower solubility and stronger metallic taste compared to chelated forms. In contrast, chelated complexes like IRON-CHOLINE CITRATE COMPLEX often exhibit improved solubility and reduced sensory impact, which can be advantageous in liquid food applications. Another comparison is with ferrous bisglycinate, another chelated iron form that is often selected for its high bioavailability and mild sensory profile. While ferrous bisglycinate has been evaluated by regulatory authorities and nutrition panels for its safety and absorption characteristics, IRON-CHOLINE CITRATE COMPLEX serves a similar functional role as a soluble iron source. Each compound presents trade-offs in terms of formulation complexity, cost, bioavailability, and sensory profile. Food formulators may choose among these iron sources based on product format, target consumer needs, and regulatory acceptance. Research on iron fortificants continues to assess how different forms influence absorption and tolerability, with chelated forms often positioned as alternatives to inorganic salts for specific applications.

Common Food Applications Narrative

In food applications, IRON-CHOLINE CITRATE COMPLEX is most often incorporated into products specifically designed to address iron insufficiency through dietary means. These products typically include fortified beverages, powdered drink mixes, nutritional shakes, and ready-to-drink formulations targeted at individuals with elevated iron needs or those who may struggle to meet dietary iron requirements through unfortified foods alone. Fortification with iron compounds such as this complex can help manufacturers offer products with enhanced nutritional value that align with specific consumer health objectives, such as supporting general well-being and preventing deficiency states. The complex's solubility and compatibility with liquid and semi-solid product formats make it suitable for use in a range of functional beverages and liquid nutritional supplements formulated for special dietary use. In addition to beverage formats, this iron source may be used in powdered nutritional supplements and meal replacement powders. Manufacturers often choose chelated forms of minerals like iron to improve their dispersion in powdered blends and minimize interactions with other components. For example, a powdered nutrition product designed for individuals on medically supervised diets may include this complex alongside other vitamins and minerals to deliver a balanced nutrient profile. Such products are typically labeled with clear ingredient declarations that reflect the presence of iron compounds, enabling informed consumer choice. The use of IRON-CHOLINE CITRATE COMPLEX in fortified foods and specialty nutrition products is guided by regulatory allowances and labeling requirements, ensuring that products provide accurate information about nutrient content. Fortified cereals, nutrition bars, and other solid foods with added nutritional profiles can also incorporate iron sources compatible with their matrices, but formulation challenges such as taste and texture must be carefully managed. Across these applications, the complex serves as one of several potential iron fortificants that food scientists and formulators can select based on solubility, stability, sensory impact, and regulatory considerations.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 172.370

EFSA

  • Notes: No specific EFSA authorisation or E number identified in the sources searched

JECFA

  • Notes: No specific entry in the JECFA database was identified for this additive

Sources

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