FD&C YELLOW NO. 6, CALCIUM LAKE

CAS: 977083-04-7 COLOR OR COLORING ADJUNCT

FD&C Yellow No. 6, Calcium Lake is a certified color additive used to impart yellow-orange hues to foods, beverages, drugs, and cosmetics. It is the calcium lake form of Sunset Yellow FCF, with regulatory listings in U.S. Federal regulations.

What It Is

FD&C Yellow No. 6, Calcium Lake is a certified synthetic food color additive in the class of colorants used to impart yellow to orange hues to a wide variety of products. It is a "lake" form of the parent dye Sunset Yellow FCF, meaning it is insoluble and bound to a calcium salt matrix, which allows it to disperse in fat-based or low-moisture applications where water-soluble colorants are less effective. The chemical is recognized under U.S. law with specific regulatory references in Title 21 of the Code of Federal Regulations, including Part 82.706 for color additive specifications and Part 176.180 for its use in indirect food-contact applications such as paper and paperboard. FD&C Yellow No. 6, Calcium Lake is part of a class of azo dyes, which are synthetic organic compounds containing one or more -N=N- (azo) functional groups linking aromatic systems. These dyes are designed for stability in typical food processing and storage conditions and can remain vibrant across different pH levels. In technical terms, a "lake" form of a dye like FD&C Yellow No. 6 results from precipitating the soluble dye with a polyvalent metal salt, such as calcium in this case, to produce an insoluble pigment. Lakes are widely used in confectionery coatings, chewing gum, and other applications where a water-soluble form might migrate out of the product or be incompatible with fats and oils. While FD&C Yellow No. 6 itself has a separate CAS number and well-established regulatory identity, the calcium lake form may be treated distinctly in certain additive inventories and specifications because of its insolubility and functional use differences. FD&C Yellow No. 6, Calcium Lake does not itself dissolve in water but disperses as fine particles, providing consistent color in products where aqueous dyes could be unsuitable. The "Calcium Lake" designation indicates a specific manufacturing form of the colorant, which enhances its utility in certain matrices, including fat-rich foods, candy coatings, and other media where water solubility is undesirable. Because of its regulated status, the additive must comply with purity and manufacturing standards to ensure the absence of harmful impurities and must be certified in each batch under FDA color additive certification procedures.

How It Is Made

The manufacturing of FD&C Yellow No. 6, Calcium Lake begins with the synthesis of the parent dye, Sunset Yellow FCF, which is produced through azo coupling reactions involving diazotization and coupling of appropriate aromatic precursors to form a stable azo chromophore. In this process, aniline derivatives and naphthalenesulfonic acid derivatives are typically converted to the diazonium form and then coupled to produce the orange-yellow azo dye. This basic synthetic chemistry for azo dyes is widely described in food additive scientific literature and regulatory monographs for colorants. Once the soluble azo dye is produced and purified, it can be precipitated as a lake pigment by adding calcium salts under controlled conditions, which forces the dye to form an insoluble complex with the calcium ions. The formation of a lake involves careful control of pH, ionic strength, and the presence of counterions so that the dye molecules bind effectively to the polyvalent metal and form particles of a specified size range. After precipitation, the lake pigment is washed to remove unreacted starting materials and soluble byproducts, then dried and milled to achieve a consistent particle size. The final pigment must meet regulatory purity specifications, which govern levels of residual solvents, unbound dye, and potential contaminants. In the U.S., color additives such as FD&C Yellow No. 6 and its lake forms are subject to batch certification by the FDA, ensuring that each manufactured lot meets defined identity and purity criteria before it enters commerce. The regulatory framework governing these manufacturing standards is codified in parts of Title 21 of the Code of Federal Regulations, which also outline permissible levels of impurities that may be present and acceptable methods of production. As a result, the manufacturing process for FD&C Yellow No. 6, Calcium Lake is designed to yield a stable pigment suitable for food, drug, and cosmetic coloring while meeting stringent regulatory criteria for human use.

Why It Is Used In Food

FD&C Yellow No. 6, Calcium Lake is used in food primarily for its ability to impart reproducible and stable yellow to orange hues that enhance the visual appeal of products. Color is a critical sensory attribute in food selection, and consistent color helps consumers form reliable expectations about product quality, flavor, and freshness. The calcium lake form of this dye is especially useful in applications where a water-soluble dye would migrate or bleed out of the product, such as in fat-containing confectionery coatings, chewing gum bases, and dry mixes. In addition to aesthetic appeal, color additives like FD&C Yellow No. 6, Calcium Lake can help mask natural variations in raw materials, making the finished product more uniform from batch to batch. This is important in large-scale food manufacturing where even minor differences in ingredient quality can lead to visually detectable variation. Using a certified color additive ensures that manufacturers can achieve target shades reliably and within regulated parameters. Regulatory frameworks require that color additives be used in amounts consistent with good manufacturing practice, meaning manufacturers must use the minimum amount necessary to achieve the desired effect. FD&C Yellow No. 6, Calcium Lake is often chosen over soluble forms when products contain fats or oils or when moisture content is low, as its insoluble nature makes it more suitable for dispersing in non-aqueous environments. Its stability across a range of processing conditions, including heat and pH variations encountered in food production, contributes to its functional utility.

Adi Example Calculation

To illustrate how an ADI could be used in a hypothetical context, consider an established acceptable daily intake of 4 milligrams per kilogram of body weight per day for Sunset Yellow FCF, which is representative of the parent dye evaluated by international authorities. For a person weighing 70 kilograms, the ADI would translate to a theoretical threshold of 280 milligrams of additive per day (4 mg/kg times 70 kg). This example is illustrative only and not a recommendation of intake. It shows how the ADI is scaled by body weight to estimate a lifetime exposure level that regulators consider unlikely to pose appreciable risk when consumed consistently over time. In practice, typical food and beverage consumption patterns result in much lower exposures to color additives than ADI values, and regulatory controls on use levels help maintain this safety margin. ADI calculations are tools used by risk assessors and regulators to contextualize exposure estimates and ensure that public health protections remain robust.

Safety And Health Research

Regulatory authorities evaluate color additives like FD&C Yellow No. 6 and its lake forms through comprehensive assessments of available toxicological data. These evaluations consider endpoints such as general toxicity, carcinogenicity, reproductive effects, and other hazard indicators from animal studies and scientific literature. Because sunset yellow dyes belong to the class of azo compounds, their safety assessment includes consideration of how they are metabolized and whether any breakdown products pose concerns at typical exposure levels. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has reviewed Sunset Yellow FCF, the parent dye for the calcium lake form, and has established an acceptable daily intake range based on the available data. Similarly, the European Food Safety Authority (EFSA) has conducted evaluations and set an acceptable daily intake that reflects the agency's review of toxicological evidence and exposure estimates. These evaluations aim to define exposure levels that do not pose appreciable health risks over a lifetime of consumption. The established ADI values are derived from animal studies with applied safety factors to account for uncertainties in extrapolating results to humans. Regulatory bodies periodically review new data to ensure that established intake limits remain appropriate given updated scientific understanding. Although concerns have occasionally been raised in the scientific literature about behavioral or other effects associated with food dyes, regulatory reviews focus on controlled toxicological evidence and exposure assessments to determine safety. Ongoing research continues to refine understanding of how these compounds behave biologically, but current regulatory positions reflect consensus evaluations of the best available data, indicating that use within specified regulatory limits is not expected to present significant health risks.

Regulatory Status Worldwide

In the United States, FD&C Yellow No. 6 and its lake forms, including FD&C Yellow No. 6, Calcium Lake, are listed color additives subject to certification and regulation by the U.S. Food and Drug Administration (FDA) under Title 21 of the Code of Federal Regulations. The inclusion of this ingredient in 21 CFR Part 82 (specifically 82.706) and Part 176.180 for indirect food contact indicates that it is an authorized additive when used according to good manufacturing practice and certification requirements. The lake form is subject to specifications that ensure identity, purity, and safety prior to distribution and use in food, cosmetic, and drug products. These regulations also specify that the additive is produced and certified in each batch to meet defined quality criteria, and may not be used in foods with standards of identity that do not permit added color unless explicitly authorized. Internationally, the parent dye Sunset Yellow FCF, which underlies the calcium lake form, is recognized by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and assigned an International Numbering System code (INS 110). JECFA has evaluated Sunset Yellow FCF and established an acceptable daily intake range based on toxicological data, indicating its evaluation and acceptance in international food additive standards. In the European Union, Sunset Yellow FCF has been assigned the E-number E110 and is permitted for use in foods with defined maximum levels and labeling requirements. The E-number designation reflects its approval as a color additive in the EU and associated regulatory controls on use levels in specific food categories. These worldwide regulatory frameworks establish that FD&C Yellow No. 6 and its lake forms are accepted as colorants when used in compliance with respective regulations and are subject to ongoing review by food safety authorities.

Taste And Functional Properties

FD&C Yellow No. 6, Calcium Lake is primarily a colorant and, when used at typical levels, is not intended to contribute any significant taste or flavor to food products. Because it is a lake pigment and insoluble in water, it does not dissolve and therefore does not directly interact with taste receptors. The primary functional property of the calcium lake form is its ability to disperse finely in food matrices where a water-soluble dye might be incompatible or susceptible to migration. From a functional standpoint, lake pigments like FD&C Yellow No. 6, Calcium Lake provide stable color throughout processing and storage, and they can withstand a variety of conditions encountered in food manufacturing, such as baking, cooling, and refrigeration. Their particle-based nature allows them to be incorporated into dry mixes, coatings, and fat-rich systems without dissolving, which helps maintain uniform color distribution. The sensory neutrality of this additive regarding taste is one reason why standardized colorants are chosen over natural extracts in some formulations; they provide predictable visual effects without affecting flavor. However, formulators must consider how the pigment interacts with other ingredients to ensure homogeneous dispersion and prevent settling or aggregation during production.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) is a regulatory concept used by food safety authorities to describe the amount of a substance that can be consumed daily over a lifetime without appreciable health risk. It is typically expressed in milligrams of additive per kilogram of body weight per day. ADI values are derived from toxicological studies in animals, where researchers identify a level at which no adverse effects are observed, and then apply safety factors to account for uncertainties when extrapolating to humans. These safety factors create a buffer that helps ensure that actual human exposures remain well below levels associated with harm. For color additives such as Sunset Yellow FCF, the parent dye underlying FD&C Yellow No. 6 and its lake forms, regulatory bodies like JECFA and EFSA have established ADI values based on comprehensive reviews of toxicological evidence. The ADI provides a framework for evaluating whether typical dietary exposures to the additive from foods and beverages are within safe bounds. It is important to understand that an ADI is not a recommended target intake, but rather a conservative safety threshold. Most consumers are unlikely to approach the ADI through normal dietary patterns, and adherence to good manufacturing practice in the use of color additives helps ensure that exposures remain controlled and within regulatory limits.

Comparison With Similar Additives

FD&C Yellow No. 6, Calcium Lake can be compared with other synthetic color additives by considering functional use and regulatory context. For example, FD&C Yellow No. 5, commonly known as tartrazine, is another synthetic yellow dye used to provide bright yellow hues in foods and beverages. Both dyes belong to the class of azo colorants and have regulatory ADI values and specifications that govern their use in products. FD&C Yellow No. 5 is typically water-soluble, whereas the lake forms such as FD&C Yellow No. 6, Calcium Lake are insoluble pigments suited for dry or fat-containing matrices. Another comparison can be made with FD&C Red No. 40, a widely used red azo dye. Like FD&C Yellow No. 6, it is subject to certification and regulatory limits in Title 21 of the Code of Federal Regulations, and it is used across a variety of food categories to achieve red or pink hues. The choice between these additives often depends on the desired color shade and product formulation needs. While both contribute visual appeal, Red No. 40 and Yellow No. 6 differ in their absorption characteristics and how they interact with other ingredients to achieve specific shades or color stability. Synthetic colorants may also be contrasted with natural color sources such as beta-carotene or annatto. Natural colors are often perceived as "clean label" alternatives, but they may offer less consistency and stability than certified synthetic lakes. FD&C Yellow No. 6, Calcium Lake and other certified colors provide predictable performance across processing conditions, making them suitable for formulations where color intensity and uniformity are priorities. The regulatory framework for synthetic color additives ensures that each is evaluated on its own safety data, functional properties, and specifications to support safe use in foods.

Common Food Applications Narrative

FD&C Yellow No. 6, Calcium Lake is found in a range of food products where color stability and visual appeal are important to consumer perception. For example, it is commonly used in confectionery coatings, chewing gum bases, and candy shells where its insoluble nature allows it to disperse evenly in sugar and fat matrices. Snacks with bright yellow-orange seasonings often use lake pigments so that the color adheres to the product surface without bleeding. Breakfast cereals and snack chips with bold colors can also contain this colorant in their seasoning blends, providing consistent hue across batches. In bakery applications, products such as icings, frostings, and decorative sugars may use calcium lake dyes to achieve vibrant visual effects that remain stable through handling and display. In beverage mixes and powdered drink formulations, FD&C Yellow No. 6, Calcium Lake may be used in combination with soluble dyes to achieve specific shades while controlling how the pigment behaves in solution or suspension. Desserts and gelatin-based products can also incorporate this colorant to enhance their appearance, contributing to the bright yellow-orange tones that appeal to consumers. Because this additive is suitable for use in low-moisture and fat-rich environments, manufacturers of snack coatings, flavored nuts, and other seasoned products often choose the calcium lake form to maintain uniform color during processing and shelf life. Its versatility across food categories reflects its function as a reliable colorant that meets regulatory requirements while helping products stand out on store shelves.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 82.706 and 21 CFR 176.180

EFSA

  • Approved: True
  • E Number: E110
  • Adi Display: 4 mg per kg body weight per day
  • Adi Mg Per Kg: 4

JECFA

  • Year: 2011
  • Ins Number: 110
  • Adi Display: 0-4 mg per kg body weight
  • Adi Mg Per Kg: 4

Sources

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