FD&C BLUE NO. 1, CALCIUM LAKE

CAS: 977011-13-4 COLOR OR COLORING ADJUNCT

FD&C Blue No. 1, Calcium Lake is a calcium salt form of the FD&C Blue No. 1 colour additive used as a colouring adjunct in regulated applications.

What It Is

FD&C Blue No. 1, Calcium Lake is a form of the synthetic colour additive commonly referenced as a "lake" of Blue No. 1. It represents the calcium salt form of the basic dye known from the broader category of FD&C Blue No.1 derivatives. As a lake, this variant is an insoluble or partially insoluble pigment form of the Blue No.1 colour, designed for specific uses in food contact or colouring applications where migration of soluble dye is not desired. The base colour additive FD&C Blue No. 1 is a synthetic triarylmethane dye evaluated by international expert committees and regulatory agencies for use in food, drugs, and cosmetics. It is known under other designations including Brilliant Blue FCF and INS number 133 in the International Numbering System for Food Additives. The calcium lake variant shares the fundamental chromophore identity of the parent dye but is bound to a calcium ion to form a pigment-like substance. In regulatory listings, the calcium lake form is separately identified when used as an indirect additive, such as for components of food packaging or contact materials, under specific sections of food contact regulations. Colour additives like FD&C Blue No. 1 and its lake forms are processed chemical entities created to impart or enhance visual appearance in products. Their classification as colour additives means they are subject to specific identity, purity, and use restrictions under food and drug regulatory regimes. In the United States, the name "FD&C" denotes approval for use in foods, drugs, and cosmetics, with the lake form included under authorised regulations for specified applications. Because it is a specialised form of the parent dye, the calcium lake is not a primary soluble colourant but is used in contexts where insoluble pigment is suitable for colouring substrates or contact materials.

How It Is Made

The manufacturing process for FD&C Blue No. 1, Calcium Lake begins with the synthesis of the Blue No. 1 chromophore itself. The base dye is prepared by condensation and oxidation of aromatic sulfonic acid precursors to create the triarylmethane structure that gives the characteristic vivid blue colour. For the lake form, the soluble dye is reacted with a source of calcium ions under controlled conditions to precipitate the dye as its calcium salt. This insoluble form adheres to substrates or remains suspended as a pigment rather than dissolving freely in water. In industrial practice, producers of colour additives must adhere to detailed purity and identity specifications set by regulatory authorities. For soluble FD&C Blue No. 1, these specifications include limits on impurities such as volatile matter, leuco base, metal contaminants, and subsidiary colours. While the literal specifications for the lake form may differ in detail, the overarching quality principles derive from the parent dye specifications and the lake production process. The calcium lake must meet defined identity and purity parameters to ensure it behaves predictably in intended applications and does not introduce unintended contaminants. Lake formation alters solubility rather than the fundamental chemical identity of the chromophore, and the process is analogous across many synthetic food colours where lake forms are desired. Manufacturers must carefully control parameters such as pH, temperature, and ionic strength during precipitation to yield a consistent lake product with acceptable particle size and colour strength. The result is a pigment-grade material suitable for incorporation into specialised applications, particularly where water solubility of the dye is not desired, or where migration control is a priority. As with all regulated colour additives, independent certification or assessment may be required for each batch used in regulated products, depending on jurisdiction and intended use.

Why It Is Used In Food

Colour additives serve a core technological function in many formulations, and FD&C Blue No. 1 and its lake forms are no exception. In foods and food contact applications, colour consistency and visual appeal are critical to consumer acceptance and product identification. The calcium lake variant provides a way to impart or maintain blue colouration in systems where the soluble form might migrate, bleed, or interact with other components. The fundamental reason manufacturers choose a lake form over a soluble dye is process compatibility. Where a product matrix or food contact surface cannot accommodate a dissolved colourant without undesirable interactions, a lake provides a particulate, stable colour source. For example, within packaging materials or coated surfaces that interact with dry foods, a lake pigment may embed more stably than a soluble dye. Although the specific regulatory listing for the calcium lake under Section 176.180 is for indirect food additives relating to paper and paperboard components in contact with dry food, the conceptual use is similar: to control colour transfer and stability. Beyond food contact materials, colour additives like Blue No. 1 affect visual perception and brand consistency in foods and beverages. Although the calcium lake form itself may not be the primary soluble colourant in a beverage or syrup, its existence as an authorised pigment form expands the formulation toolbox for product developers. In many instances, formulation choices come down to stability, migration control, and appearance in finished products. The availability of lake forms supports these design goals by offering a form of the colour that behaves differently in suspension or in contact matrices than the soluble counterpart.

Adi Example Calculation

To illustrate the concept of an acceptable daily intake (ADI), suppose a hypothetical ADI for the parent dye is defined as a range with an upper bound of 6 milligrams per kilogram of body weight per day. For an adult weighing 70 kilograms, this would translate to an ADI of 420 milligrams per day as an upper bound. In practice, typical dietary exposure from coloured foods is far lower, often only a fraction of this amount. For example, if a person consumes multiple products containing the colour additive and the combined intake totals 10 milligrams in a day, this would be well below the illustrative ADI of 420 milligrams for a 70-kilogram adult. The comparison underscores that normal use levels in food formulations are designed to result in exposures that remain comfortably below safety limits established by regulatory science. Consumer exposure can vary based on diet, product formulations, and frequency of consumption, but safety evaluations account for these patterns when setting regulatory limits. This example is illustrative and not a recommendation for individual intake. It demonstrates how ADI values are scaled based on body weight and how typical exposures tend to be a small fraction of safety thresholds. The ADI serves as a reference point for regulators to ensure that authorised use levels in food products do not pose health risks to consumers over a lifetime of exposure.

Safety And Health Research

Safety evaluations for colour additives like FD&C Blue No. 1 derive from extensive toxicological studies that examine potential effects across multiple biological systems. Expert committees such as JECFA assess data from chronic toxicity, reproductive studies, genotoxicity assays, and absorption-distribution-metabolism-excretion profiles to establish points of departure for safety evaluation. For FD&C Blue No. 1, these evaluations have led to the establishment of acceptable daily intake limits for the parent dye. These limits reflect the amount of the compound that can be consumed daily over a lifetime without appreciable health risk. Animal studies have been a cornerstone of such evaluations, with chronic feeding studies providing critical data on potential adverse effects at high exposure levels. The results inform the derivation of safety factors that account for differences between test animals and humans, and variability within human populations. Regulatory bodies examine these data in light of exposure estimates from typical dietary sources to determine whether normal use patterns present a safety concern. For the parent dye, the conservative upper bound of the acceptable daily intake reflects this comprehensive risk assessment. Pertinent to the calcium lake form, the lake itself does not introduce a new chromophore or fundamentally different molecular entity from the soluble form. Rather, it alters solubility and migration characteristics. Because systemic absorption from lake forms is expected to be limited relative to a soluble dye, exposure assessment focuses on the underlying chromophore's safety profile. Regulatory authorities rely on established toxicological evaluations of the base dye when considering safety in use contexts. This approach aligns with scientific consensus that the core chemical identity, rather than the salt form, drives systemic toxicological outcomes. Overall, safety and health research underscores that colour additives undergo rigorous scrutiny before and after regulatory approval. Evaluations consider multiple endpoints and integrate uncertainty factors to ensure consumer protection across life stages and consumption patterns.

Regulatory Status Worldwide

The regulatory status of FD&C Blue No. 1 and its derivatives, including the calcium lake form, reflects decades of evaluation by food safety authorities. In the United States, colour additives are subject to specific listings within the Code of Federal Regulations. The soluble FD&C Blue No. 1 is listed in Part 74 for general use in foods, drugs, and cosmetics and is subject to batch certification, identity, and purity requirements. The calcium lake form is referenced under Part 176.180 as an indirect food additive for use in components of paper and paperboard in contact with dry foods. These listings indicate that regulatory authorities have defined permitted use contexts and associated controls for safe application. Internationally, the parent dye Brilliant Blue FCF, which corresponds chemically to FD&C Blue No. 1, has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives. JECFA established an acceptable daily intake range of 0–6 mg per kilogram of body weight based on comprehensive toxicological data. This global evaluation supports the safety of the compound within specified intake limits. In addition, scientific bodies such as the European Food Safety Authority have reviewed similar data and reaffirmed safety conclusions for the parent dye under defined conditions of use. Regulatory frameworks outside the United States often reference these authoritative evaluations when setting their own standards. Because the calcium lake form is a derivative of the same chromophore, its regulatory acceptance is tied to the identity of the base dye and the specific use conditions under which it is authorised. Regulations governing lakes ensure that the form used is consistent with regulatory definitions and specifications, and that any consumer exposure from contact with food is consistent with safety assessments of the underlying compound's toxicological profile.

Taste And Functional Properties

Colour additives like FD&C Blue No. 1 and its lake forms are engineered to contribute visual characteristics rather than taste or functional nutritional properties. In general terms, the presence of a colourant at typical use levels does not impart a perceptible flavour or mouthfeel, and this holds true for the calcium lake variant. Because the lake form tends to remain as an insoluble pigment, it is unlikely to dissolve in aqueous phases where taste perception would be engaged, and is instead associated with surfaces or suspended systems where visibility rather than taste impact is desired. Functional properties of the lake form focus on its stability under various processing conditions. Lakes are generally more stable to migration and leaching than their soluble counterparts, which makes them suitable for applications where water solubility would lead to bleed or colour drift. As an insoluble pigment, the calcium lake form resists dissolution in water, which can help preserve consistent visual appearance over time and under varying humidity or contact conditions. These physical properties are important in food contact applications where uncontrolled colour migration could compromise product quality. Additionally, colour lakes often exhibit predictable behaviour under heat and pH variation, although specific performance characteristics depend on the formulation. The insoluble particles can resist rapid colour loss in environments where soluble dyes might partition into adjoining phases or be affected by ionic strength. Although colour perception is not directly related to functional taste, the consistency of hue and absence of off-notes contributes to consumer acceptance by aligning with expected sensory experience. As such, the lake form helps decouple colour function from taste or other sensory attributes, allowing manufacturers to achieve visual goals without unintended organoleptic effects.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) represents a level of a substance that can be consumed every day over a lifetime without appreciable health risk. Regulatory bodies derive the ADI using toxicological data from animal studies where doses are administered at levels far higher than typical human dietary exposure. The no-observed-adverse-effect level (NOAEL) from such studies provides a reference point. Scientists apply uncertainty factors to account for differences between species and human variability, yielding a conservative exposure limit. For colour additives like the parent form of FD&C Blue No. 1, such evaluations inform the ADI range. It is important to emphasise that the ADI is not a recommended intake but rather a safety benchmark. Most consumers are exposed to levels far below the ADI through normal dietary consumption of coloured foods and beverages. The ADI helps regulators define safe use conditions and ensure that cumulative exposure from multiple sources remains within safe bounds. Because calcium lake forms have limited solubility, ingestion exposure is generally lower than for soluble forms, but safety assessments reference the same underlying toxicological profile. Understanding the ADI can help contextualise regulatory decisions. It reflects a lifetime safety standard, not a short-term threshold for acute effects. Consumer exposure is evaluated in relation to this benchmark to ensure that broad use in food products does not lead to intake approaching safety limits. The ADI thus serves as a tool for regulators and manufacturers to align product formulations with established safety science.

Comparison With Similar Additives

When comparing FD&C Blue No. 1, Calcium Lake to other colour additives, it is helpful to consider lakes and soluble forms within the broader class of synthetic colours. For instance, FD&C Yellow No. 5 and FD&C Red No. 40 are also synthetic colourants that come in both soluble and lake forms. All of these are subject to identity and purity specifications and require regulatory evaluation to define acceptable use conditions. What distinguishes the lake forms from the soluble forms is not the colour function itself but how the additive interacts with the product matrix. Lakes tend to remain as particulate pigments, whereas soluble forms dissolve in water-based systems. From a performance perspective, soluble dyes like FD&C Yellow No. 5 readily impart colour in beverages and aqueous food systems but can migrate or bleed in systems where moisture is present. In contrast, lake forms of Yellow No. 5 or Red No. 40 provide stable colour in dry applications such as coated confectionery or packaging materials. The calcium lake form of Blue No. 1 follows a similar pattern: it is chosen when insoluble pigment characteristics support product formulation goals. Technologically, natural colourants such as spirulina extract or anthocyanins offer alternatives to synthetic colours but often face challenges in stability, hue consistency, and pH sensitivity. Synthetic lakes provide more predictable performance across a range of conditions. When formulating foods with consistent appearance, manufacturers weigh the benefits of colour stability, regulatory acceptance, and consumer expectations. Colour additives like the calcium lake form of Blue No. 1 thus occupy a niche where insolubility and regulated use conditions align with application needs.

Common Food Applications Narrative

In the world of food additives, colour plays a central role in defining consumer perception and product identity. The Blue No. 1 family of colourants, including the calcium lake variant, has a long history in regulated applications where visual cues are essential. While the soluble form of Blue No. 1 is widely used to impart vivid blue tones in beverages, confectionery, dairy products, and processed foods, the calcium lake form serves distinct roles in supporting colour stability and controlled migration, particularly in food contact materials and specialised formulations. The calcium lake variant is authorised under specific regulatory sections that cover indirect food additives, such as components of paper and paperboard in contact with dry foods. This means it may be encountered in packaging materials that come into contact with products like dry snacks, cereals, and baked goods where the design goal is to prevent colour migration from packaging into the product. In such contexts, formulators seek additives that help maintain the integrity of both the packaging and the contained food, preventing undesirable transfer of colour into the food matrix itself. Although the soluble FD&C Blue No. 1 is more familiar in direct colouring of consumer foods, the availability of a lake form demonstrates how colour technology adapts to meet diverse manufacturing needs. For example, in coated papers used for wrapping dry foods, the calcium lake form can provide lasting colour without dissolving under humid conditions. Similarly, in formats where dry mixes are coloured for visual identification but not intended to solubilise in water, a pigment-like form can offer consistent results. This versatility supports broader product categories where colour function must be carefully managed without compromising food quality or safety.

Safety & Regulations

FDA

  • Notes: Approved for specified indirect food contact use under 21 CFR 176.180 as listed; direct use approval for colouring foods is not directly established for the calcium lake form.
  • Regulation: 21 CFR 176.180

EFSA

  • Notes: ADI for the base dye Brilliant Blue FCF established by international evaluation.
  • Approved: True
  • E Number: E133
  • Adi Display: 0-6 mg per kg bw
  • Adi Mg Per Kg: 6

JECFA

  • Year: 2017
  • Notes: ADI for the parent dye established by the Joint FAO/WHO Expert Committee on Food Additives in 2017.
  • Ins Number: 133
  • Adi Display: 0-6 mg per kg bw
  • Adi Mg Per Kg: 6

Sources

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