FD&C YELLOW NO. 5, CALCIUM LAKE

CAS: 977011-18-9 COLOR OR COLORING ADJUNCT

FD&C Yellow No. 5, Calcium Lake is a certified inorganic pigment form of the synthetic colorant tartrazine used as a coloring adjunct in foods, drugs, and cosmetics subject to regulatory certification.

What It Is

FD&C Yellow No. 5, Calcium Lake is a color additive used to impart yellow color to a variety of consumable products. It is a lake form of the synthetic dye tartrazine, meaning the soluble dye component has been precipitated with a metallic salt, in this case calcium, to create an insoluble pigment. As a lake, FD&C Yellow No. 5, Calcium Lake is categorized under color additives that must be batch certified prior to use in products regulated by the United States Food and Drug Administration (FDA). Color additives such as this are listed and regulated in Title 21 of the Code of Federal Regulations (CFR). For FD&C Yellow No. 5, Calcium Lake, specific regulatory references include 21 CFR 82.705 and 21 CFR 176.180 which govern its listing and conditions of use in food and indirect food contact materials. The calcium lake form of the dye has physical properties that differ from the water-soluble parent dye, making it suitable for dry or low-solubility applications in products where direct dye solubility is not desired. While tartrazine itself has an International Numbering System (INS) number of 102 and a related E number (E102) in the European Union, the lake forms often carry the same functional designation but differ in solubility and particle structure due to the metal salt substrate used. FD&C Yellow No. 5, Calcium Lake is recognized by regulatory inventories as a specific entry in lists of allowed color additives for defined uses.

How It Is Made

The manufacture of FD&C Yellow No. 5, Calcium Lake begins with the synthesis of the water‑soluble dye tartrazine, which is prepared through diazotization and coupling reactions involving aromatic sulfonic acid derivatives. Once the soluble colorant component has been formed and purified, it is reacted with a calcium salt under controlled conditions to produce an insoluble lake pigment. In this process, the dye molecules adsorb onto or bind with the inorganic substrate (calcium), forming solid particles that are resistant to dissolution in water. This lake formation technique is employed to convert a soluble dye into a form that can disperse in non‑aqueous systems or retain color without migrating into aqueous phases. The resulting pigment is filtered, washed, and dried to achieve a stable powder that meets defined specifications for identity and purity under regulatory color additive standards. Lake pigments such as FD&C Yellow No. 5, Calcium Lake are subject to batch certification by authorities like the FDA to ensure that each production lot conforms to the tested and approved quality profile. In industrial practice, careful control of pH, temperature, and reagent ratios during the lake formation process is critical to achieving consistent color strength and particle size. The inert inorganic substrate, in this case calcium, contributes to the final pigment’s physical performance in formulations. This manufacturing approach is common for lake pigments based on azo dyes, which are a class of synthetic organic compounds known for their vivid colors and utility in food, drug, and cosmetic applications.

Common Misconceptions

A common misconception about color additives like FD&C Yellow No. 5, Calcium Lake is that their presence automatically implies negative health effects. Regulatory assessments conducted by expert committees and food safety authorities are designed to evaluate toxicological evidence and establish safety benchmarks such as acceptable daily intake values. These benchmarks incorporate large safety margins to account for uncertainties and ensure consumer protection. Another misconception is that all forms of a dye behave identically; in reality, lake forms differ from soluble dyes in terms of solubility and dispersion characteristics, which affects formulation decisions in food products. Because color additives are used at low concentrations and subject to batch certification and regulatory oversight, their use in permitted applications reflects compliance with safety and quality standards. Awareness of regulatory processes and how safety benchmarks are established can help clarify misunderstandings about the presence of certified color additives in foods.

Why It Is Used In Food

FD&C Yellow No. 5, Calcium Lake is used in foods because it delivers visual appeal by enhancing or imparting a bright yellow hue that can make products more attractive to consumers. Color has a strong influence on how people perceive the freshness, flavor, and quality of many foods, and food formulators often rely on certified color additives to achieve consistent and stable color in packaged and processed products. As a lake pigment, this form of the dye offers advantages in products where direct water solubility is not desirable or where color needs to remain evenly dispersed in systems that include fats, emulsions, or dry mixes. For example, in confectionery, baked goods, or snack coatings, a lake form can provide a resilient yellow shade that resists migration and fading during storage and processing. The insoluble nature of the lake also allows for use in products where moisture control is necessary. The regulatory requirement for batch certification ensures that each manufactured lot meets approved standards for purity and composition before it is permitted in food, drug, or cosmetic products. This certification step is part of why industry chooses such certified color additives: they offer both reliable functional performance and compliance with labeling and safety requirements in regulated markets. The stable yellow color provided by FD&C Yellow No. 5, Calcium Lake is especially valued in consumer products where consistent visual appearance is part of the brand experience.

Adi Example Calculation

To illustrate how an acceptable daily intake (ADI) concept works, consider a hypothetical adult body weight of 70 kilograms. If an international committee established an ADI of up to a defined number of milligrams per kilogram body weight per day for the parent dye of FD&C Yellow No. 5, Calcium Lake, multiplying the ADI value by body weight would yield the total amount considered within the safety benchmark for that individual. For example, if an ADI value were available from a regulatory evaluation process, that number multiplied by 70 kilograms would reflect the lifetime daily intake that authorities consider to be within an acceptable margin. It is important to note that this calculation is purely illustrative and should not be interpreted as dietary advice or a specific consumption target. Actual exposure depends on the levels of the additive in food products and the quantity of those products consumed in a typical diet. Regulatory intake assessments use population dietary data and additive usage levels to estimate exposure relative to the ADI and ensure that typical consumption patterns remain under the conservative benchmark established by regulatory evaluations.

Consumer Labeling Guidance

In regions such as the United States, products that contain FD&C Yellow No. 5 or its lake forms must list the color additive by name in the ingredient statement. For example, a product label might include "FD&C Yellow No. 5 (tartrazine)" to clearly identify the presence of the certified color. This labeling requirement supports transparency and allows consumers to identify specific additives in products. Labeling rules vary by jurisdiction, and in some cases, additional descriptors or codes such as E numbers may be permitted on consumer labels in Europe and other regions. Understanding these labeling conventions helps consumers make informed choices when purchasing products that contain certified color additives.

Safety And Health Research

Safety evaluations of synthetic color additives related to FD&C Yellow No. 5, including tartrazine, have been conducted by expert committees that review toxicological data, exposure assessments, and laboratory studies. International organizations such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) have assessed tartrazine, establishing acceptable intake thresholds based on comprehensive review of chronic animal studies and other toxicological endpoints. These evaluations consider potential effects across multiple organ systems and assess data quality to inform regulatory guidance. Similarly, regulatory agencies in various regions have commissioned scientific opinions and re‑evaluations of tartrazine and its derivatives to ensure that existing data support continued use within established safety margins. These assessments examine available evidence on genotoxicity, carcinogenicity, and other toxicological outcomes to inform risk management decisions. Scientific literature continues to grow with new studies that evaluate the properties of azo dyes and their metabolites under different exposure scenarios, contributing to the overall body of evidence that regulators review when re‑assessing safety profiles. Overall, the body of regulatory safety research emphasizes a weight‑of‑evidence approach, considering lifetime exposure levels relative to conservative intake thresholds and examining a range of experimental findings. While individual studies may explore detailed mechanisms or specific outcomes, broad regulatory evaluations provide context for how such findings fit into overall assessments of food additive safety.

Regulatory Status Worldwide

In the United States, FD&C Yellow No. 5, Calcium Lake is recognized as a certified color additive permitted for use in foods under specific regulations in Title 21 of the Code of Federal Regulations. The regulatory references for this ingredient include approvals and listing conditions in 21 CFR 82.705 and indirect food contact provisions under 21 CFR 176.180, which govern allowable uses and conditions for substances that may contact food packaging. Certification requirements stipulate that each production batch be tested and approved before it can be used in regulated products. These regulations are designed to ensure that the additive meets defined identity and purity criteria prior to commercial use. In other regulatory jurisdictions, a closely related form of the soluble dye component tartrazine is assigned the E number E102 and has undergone evaluation by bodies such as the European Food Safety Authority (EFSA). Although the lake form itself may not be explicitly detailed in every international code, the parent dye and its lake derivatives are generally understood to be subject to analogous safety evaluations and permitted uses where approved. International expert committees such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) have evaluated tartrazine and related colorants to provide guidance on acceptable daily intake and specifications, which inform many national regulatory frameworks. Because of these evaluations and listings, manufacturers using FD&C Yellow No. 5, Calcium Lake must adhere to labeling and purity requirements in each market where the product is sold, ensuring that consumer information reflects the presence of certified color additives in accordance with local regulations.

Taste And Functional Properties

FD&C Yellow No. 5, Calcium Lake is primarily a colorant and does not contribute significant taste or aroma to the products in which it is used. The pigment form is insoluble in water, making it suitable for applications where a dispersed particulate color is needed rather than a dissolved dye. Because it does not readily dissolve, the lake pigment remains in suspension or evenly distributed throughout a formulation, rather than migrating into aqueous phases. From a functional perspective, lake pigments are generally stable to a range of processing conditions including heat, light, and pH changes that occur during cooking, baking, or product storage. This stability helps ensure that the intended color remains vivid throughout the shelf life of the finished product. The insoluble nature of the calcium lake form also means that it can be used in low‑moisture products and dry mixes without affecting texture or solubility profiles. Because FD&C Yellow No. 5, Calcium Lake does not contribute flavor and its particles are designed to be nonreactive, formulators rely on it strictly for visual enhancement rather than sensory modification. Functional performance in terms of color intensity and dispersion depends on particle size, formulation matrix, and processing conditions, and careful formulation ensures that the pigment performs as expected without unintended changes to product quality.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) is a regulatory concept used to describe the amount of an additive that can be ingested daily over a lifetime without appreciable risk, based on available toxicological data and uncertainty factors. Regulatory bodies such as JECFA analyze animal studies to identify a level at which no adverse effects are observed and then apply safety factors to account for differences between experimental animals and humans as well as variability within human populations. The resulting ADI provides a conservative threshold for risk management. The ADI for tartrazine, the parent dye for FD&C Yellow No. 5, Calcium Lake, has been established by international committees based on toxicological evaluations. These values are used by national and regional regulators to guide permissible levels in foods and to inform exposure assessments. It is important to understand that an ADI is not a recommended consumption level; rather, it represents a safety benchmark that helps ensure that everyday dietary exposures remain well below levels associated with potential effects in toxicological studies. Because color additives are used at low concentrations in food products, typical intakes for most individuals are expected to fall below the established ADI when products are consumed in normal dietary patterns.

Comparison With Similar Additives

FD&C Yellow No. 5, Calcium Lake belongs to a broader class of azo dye based color additives that include other well‑known substances such as FD&C Yellow No. 6 (Sunset Yellow) and FD&C Red No. 40. All of these additives are synthetic organic colorants used to deliver vivid hues in foods, drugs, and cosmetics. They differ in their chemical structures and resulting color characteristics, with Yellow No. 5 producing a bright lemon yellow shade, Sunset Yellow offering a deeper orange‑yellow, and Red No. 40 providing a red spectrum color. Lake forms of these dyes, including calcium or aluminum lakes, share the functional characteristic of being insoluble pigments. This contrasts with their water‑soluble counterparts, which dissolve in aqueous systems and are suited to liquid applications. The choice between a lake pigment and a soluble dye depends on product formulation needs, such as the desire for stability in dry mixes or emulsions. In terms of regulatory evaluation, all of these color additives have been subject to safety assessments by authoritative bodies, and acceptable intake thresholds have been defined based on toxicological evidence. While their structures and performance profiles differ, comparison across similar additives helps formulators and regulators understand relative properties such as color strength, stability under processing conditions, and typical use levels in various product categories.

Common Food Applications Narrative

FD&C Yellow No. 5, Calcium Lake finds application across a range of food and beverage products where a stable and vibrant yellow color is desired. In everyday consumables such as confections, snacks, and baked goods, color helps deliver an appealing visual cue that aligns with consumer expectations for freshness and flavor identity. For instance, the bright yellow tone provided by this pigment can be used to accentuate the appearance of icings, frostings, or decorative coatings on sweets, where visual contrast and uniformity enhance the eating experience. In grain‑based snacks or breakfast cereals, the consistent dispersion of the lake pigment ensures even color distribution, which supports product quality and marketability. In processed cheese and dairy products, color additives like this are often used to achieve uniformity in hue that may not be naturally present due to variations in base ingredients. Beverage powders and flavored drink mixes may also incorporate lake colorants to deliver a recognizable shade after reconstitution, again focusing on consumer perception rather than taste contribution. Across these varied applications, the use of FD&C Yellow No. 5, Calcium Lake aligns with technological needs for color consistency, stability during processing, and compliance with regulatory labeling and safety requirements. Its role is to provide a visually appealing and stable yellow color that enhances product appearance while meeting the conditions of use defined by regulatory authorities.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 82.705

EFSA

  • Notes: EFSA has evaluated tartrazine as E102 but specific numeric ADI for the lake form was not located in linked evidence.
  • E Number: E102

JECFA

  • Notes: JECFA evaluations provide a range for tartrazine but exact numeric ADI value not shown on the d entry.
  • Ins Number: 102
  • Adi Display: 0-10 mg/kg bw

Sources

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