IRON CITRATE

CAS: 2338-05-8 NUTRIENT SUPPLEMENT

Iron citrate (CAS 2338-05-8) is a compound of iron and citric acid used as a nutrient supplement in food applications. According to US regulations, iron citrate is prepared from citric acid and ferric hydroxide and used as a food nutrient supplement with no limitation other than good manufacturing practice. It is also permitted in infant formula under applicable sections of US law. Ferric citrate appears as a reddish to brown solid compound and serves as a source of dietary iron.

What It Is

Iron citrate is a chemical compound defined by the CAS number 2338-05-8 and identified as a nutrient supplement under food regulatory frameworks. In regulatory listings, it is referred to as ferric citrate, an iron (III) citrate complex prepared from citric acid and ferric hydroxide. As a nutrient supplement, iron citrate functions as a source of iron, an essential mineral nutrient in the diet. Within food additive classification systems, nutrient supplements are compounds added specifically to complement or fortify foods with vitamins or minerals that may be lacking or to help meet nutritional requirements. In the context of regulatory and safety documentation, iron citrate is recognized for its role as a mineral fortification agent rather than as a flavoring or processing aid. It is included in relevant regulatory references where it is affirmed as Generally Recognized As Safe (GRAS) when used appropriately in foods, including certain applications such as infant formula under designated legal provisions. While scientific and technical literature describe iron citrate’s chemistry and properties, its primary identification as a food additive stems from its contribution to dietary iron intake and compliance with applicable food safety standards. It does not have a widely recognized E-number in the European Union based on available authoritative sources, and its approval status beyond US regulatory citations requires specific regional verification.

How It Is Made

The production of iron citrate involves the reaction of ferric hydroxide with citric acid under controlled conditions. This reaction forms a chelated compound in which ferric ions (iron in the +3 oxidation state) complex with citrate ions derived from citric acid. The specific ratio of iron to citrate in the final product may vary depending on the manufacturing process and desired product specification, with purification steps typically ensuring a suitable level of purity for its intended use in food applications. In practice, manufacturers use high-purity food-grade reagents and controlled aqueous environments to facilitate complex formation and to minimize contaminants. After the chelation reaction, the product is isolated and dried to produce a stable solid form. Final product quality is verified against established standards for mineral supplements in food, ensuring compliance with regulatory criteria. Iron citrate used in food applications must meet purity standards appropriate to its function, with specifications governing permissible levels of impurities and consistent chelation of iron to citrate. Good manufacturing practices further guide its production, handling, and storage to maintain the integrity of the compound until incorporation into food matrices.

Why It Is Used In Food

Iron citrate is used in food primarily to fortify products with iron, a mineral nutrient essential for physiological processes such as oxygen transport and energy metabolism. Iron deficiency is among the most common nutritional gaps worldwide, and food fortification strategies are widely adopted to help address this public health concern. Adding iron citrate to foods provides a bioavailable source of iron that can help increase dietary iron intake when naturally occurring levels are insufficient. Unlike some inorganic iron salts that may have lower solubility or distinct sensory impacts, iron citrate offers an alternative that may integrate more seamlessly into certain food products. It is used in a variety of fortified foods including cereals, beverages, and dairy and non-dairy products where enhanced iron content helps meet consumer nutrient expectations or regulatory requirements for nutrient labeling. As a nutrient supplement in food formulations, iron citrate complements broader nutritional strategies that aim to deliver essential minerals without significantly altering product taste, texture, or appearance, thereby maintaining consumer acceptance.

Adi Example Calculation

To illustrate how intake considerations might be applied using nutrient reference values, consider a hypothetical 70 kg adult consuming fortified cereal providing supplemental iron from iron citrate. If iron citrate is formulated to contribute 10 mg of elemental iron per serving, a single serving contributes that amount toward the daily iron intake. When interpreted alongside established nutritional reference values for iron intake, this supplemental contribution can be evaluated in light of total expected daily intake from all dietary sources. This example is illustrative and does not represent a personal recommendation. It highlights how manufacturers and regulators assess nutrient contributions from fortified foods relative to broader dietary intake expectations. Regulatory and public health agencies provide guidance on safe intake levels that encompass all dietary iron sources, and fortification strategies are calibrated accordingly to avoid exceeding safe upper limits while addressing nutrient insufficiency.

Safety And Health Research

Safety evaluations for food additives like iron citrate consider both the inherent properties of the compound and the expected dietary exposure from fortified foods. Regulatory agencies assess toxicological data, including acute and chronic animal studies, to determine whether consumption at typical use levels poses health risks. For iron citrate, the primary concern in safety assessment relates to iron exposure, as excessive iron intake can be harmful; however, regulatory frameworks focus on ensuring that fortification levels align with nutritional guidance and do not lead to intake amounts that exceed safe upper limits from all dietary sources. Research on iron and iron salts more broadly encompasses absorption, bioavailability, and potential interactions with other dietary components, rather than agent-specific toxicity of the citrate complex itself. In evaluating safety, authorities examine factors such as genotoxicity, long-term toxicity, and reproductive endpoints in relevant studies. When evidence does not indicate significant hazards at expected levels of exposure, and when appropriate manufacturing controls and specifications are in place, additives like iron citrate are authorized for their intended nutritional purposes. It is important to note that safety evaluations differentiate between nutrient deficiencies, which require adequate intake, and excessive intake, which is mitigated through regulatory limits and guidance on fortification levels. Ongoing research and post-market surveillance contribute to updating safety assessments where necessary.

Regulatory Status Worldwide

In the United States, iron citrate is listed under Title 21 of the Code of Federal Regulations at section 184.1298, where ferric citrate is affirmed for use in food as a nutrient supplement with no limitation other than good manufacturing practice. The regulation also notes its permitted use in infant formula under applicable provisions of the Federal Food, Drug, and Cosmetic Act, indicating its acceptance in specialized nutritional products when conditions of use are met. This regulatory citation reflects a positive safety determination by the US Food and Drug Administration for intended uses specified in dietary fortification contexts. Beyond the US, formal approval status in other major regulatory jurisdictions such as the European Union requires specific local verification. Iron citrate does not have a widely recognized E-number in the EU based on available deep source data, and absence of such an E-number does not imply safety concerns but highlights the need for region-specific regulatory review. International expert bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) maintain comprehensive databases of evaluated food additives and specifications, which can inform regional risk assessments and permissible use conditions. For global markets, manufacturers rely on relevant codex listings, regional approvals, and compliance with local food laws to determine allowable food categories and conditions of use for iron citrate. Regulatory frameworks may differ in labeling requirements and nested nutrient reference values, and compliance with each jurisdiction’s standards is integral to market authorization.

Taste And Functional Properties

In sensory terms, iron citrate contributes minimally to taste at typical fortification levels in food products. While some iron salts can impart metallic or astringent notes when present at higher concentrations, iron citrate is often selected for fortification because its chelated form tends to interact less strongly with flavor components, resulting in reduced sensory impact. Manufacturers calibrate iron citrate inclusion to achieve desired iron content while minimizing any perceptible alteration in the food matrix’s sensory profile. Functionally, iron citrate is water soluble, which facilitates its incorporation into liquid and dry food systems. Its stability in solution and compatibility with other ingredients make it suitable for a range of applications, and it can withstand typical food processing conditions without significant degradation of iron content. The chelated form helps maintain iron in a bioavailable state, enhancing potential nutritional benefits. However, the specific functional performance in any given food depends on formulation, pH, and processing conditions, and developers often conduct product-specific evaluations to optimize its use.

Acceptable Daily Intake Explained

An Acceptable Daily Intake (ADI) describes the amount of a substance that can be consumed daily over a lifetime without appreciable health risk, based on toxicological evidence and safety factors. For nutrient supplements such as iron citrate, formal ADI values may not be established in the same way as for other food additives; instead, nutritional reference values such as Recommended Dietary Allowances (RDAs) for iron guide safe and adequate intake. Regulatory risk assessments consider total dietary iron from all sources, including naturally occurring iron in foods and fortified products, when evaluating safety. The concept of ADI can still apply where iron citrate contributes to overall iron exposure, and risk assessors ensure that typical fortification levels do not cause intake to exceed tolerable upper intake levels established for iron. These tolerable limits account for bioavailability and potential effects of excessive iron, and adequate margins of safety are incorporated to protect diverse population groups.

Comparison With Similar Additives

Iron citrate can be compared with other iron-containing food fortification agents such as ferrous sulfate, ferric pyrophosphate, and ferric EDTA. Ferrous sulfate is a common iron fortificant known for high bioavailability but may impart sensory changes like metallic taste if present at higher levels. Ferric pyrophosphate is another iron source with lower solubility but reduced impact on food appearance and flavor, making it suitable in certain dry food applications. Ferric EDTA, a chelated iron form, enhances solubility and stability in some matrices but has distinct chemical properties compared to citrate-chelated iron. Each of these additives serves the shared purpose of providing supplemental iron in fortified foods, yet their functional performance and sensory profiles differ depending on formulation context and target consumer experience.

Common Food Applications Narrative

Iron citrate is widely used as a mineral fortification ingredient in a variety of food and beverage categories designed to deliver supplemental iron to consumers. It serves as a source of dietary iron in fortified cereals, nutrition bars, and powdered beverage mixes that target general health and wellness. In addition to these applications, iron citrate can be found in liquid nutritional drinks where iron fortification supports labeled nutrient content claims. Manufacturers also incorporate iron citrate into certain dairy and plant-based dairy-alternative products to enhance their mineral profile, aligning with consumer interest in products that support balanced nutrition. In grain and flour products, iron citrate may be included as part of a fortification program to address iron insufficiency in the population, particularly in regions where regulatory policies or public health initiatives encourage nutrient enrichment. While the specific use levels vary by product type and formulation goals, iron citrate’s solubility and technical properties facilitate its integration into fortified foods without compromising processing performance or product quality. Across these applications, iron citrate’s role is to help deliver essential iron within diverse food formats in a manner that supports nutritional value while maintaining desirable sensory and functional characteristics.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 184.1298

EFSA

  • Notes: EFSA approval status not verified from authoritative source

JECFA

  • Notes: JECFA evaluation for iron citrate not verified in available JECFA database links

Sources

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