FD&C YELLOW NO. 6, ALUMINUM LAKE

CAS: 15790-07-5 COLOR OR COLORING ADJUNCT, FLAVOR ENHANCER, FLAVORING AGENT OR ADJUVANT

FD&C Yellow No. 6 Aluminum Lake is a certified synthetic color additive used to impart orange-yellow color in foods, pharmaceuticals and cosmetics; it is the aluminum lake form of the Sunset Yellow FCF colorant.

What It Is

FD&C Yellow No. 6, Aluminum Lake is a synthetic color additive used to add or enhance orange-yellow color in food and other products. The term "lake" refers to the aluminum salt form of a colorant, where the dye is adsorbed onto an aluminum substrate to create an insoluble pigment suitable for use in low-moisture or oil-containing food systems. This specific additive is derived from Sunset Yellow FCF (often denoted by INS 110 or E110) and carries the CAS registry number 15790-07-5, distinguishing it from the water-soluble Sunset Yellow FCF disodium salt form. Food color additives are regulated chemical substances intentionally added to foods to achieve desired color effects within defined safety and purity specifications. In the United States, substances like FD&C Yellow No. 6 and its aluminum lake form are addressed through the Food and Drug Administration's color additive regulations, which require certification of batches to ensure they meet identity and purity criteria. A "lake" form changes the physical properties of the dye, making it suitable for dry mixes, confectionary coatings, tablets, and other applications where water solubility is undesirable. The colorant functions primarily as a coloring agent but may have secondary roles such as supporting visual consumer appeal. Its inclusion in formulations must comply with relevant labeling requirements, so consumers are informed of its presence in finished products. Lake color additives like FD&C Yellow No. 6 Aluminum Lake are distinct from direct dyes in that they do not dissolve in water but rather disperse uniformly in the medium where they are applied, providing a consistent and stable color effect. This allows product developers to achieve specific visual characteristics while maintaining formulation stability across a range of food matrices. The presence of the aluminum substrate also influences how the colorant performs under various processing conditions, contributing to its selection in certain applications.

How It Is Made

The aluminum lake of FD&C Yellow No. 6 is manufactured by combining the parent dye solution with aluminum salts under controlled conditions to form a precipitated pigment. In general, a soluble colorant such as Sunset Yellow FCF is reacted with an aluminum salt (often aluminum hydroxide or aluminum sulfate) to form an insoluble complex that adsorbs the dye molecules onto the aluminum substrate. This process creates the lake pigment, which is then filtered, washed, and dried to produce a powder that meets established identity and purity criteria. While specific proprietary manufacturing methods vary among producers, the overarching principle involves careful control of pH, temperature, and reagent stoichiometry to ensure that the aluminum lake pigment binds the dye consistently and produces a uniform particle size distribution. The resulting aluminum lake pigment is typically milled and standardized to achieve consistent color strength, particle size, and dispersion characteristics suitable for use in dry confectionery, coatings, tablet formulations, and other products where water solubility is not suitable. Lake colorants like FD&C Yellow No. 6 Aluminum Lake must meet defined regulatory specifications for impurities, heavy metals, and absence of undesired byproducts. In the United States, specifications are outlined in the Code of Federal Regulations for certified color additives, which describe acceptable limits for volatile matter, insoluble materials, and trace contaminants. Manufacturers often conduct additional quality control testing beyond regulatory requirements to verify color strength and performance attributes for specific applications. The chemistry of azo-based dyes such as Sunset Yellow involves diazotization and coupling reactions to form the chromophore, and the subsequent lake formation with aluminum adds a particle engineering step that confers utility in certain product formats.

Why It Is Used In Food

Color plays a vital role in consumer perception and product appeal. Foods that possess vibrant and consistent colors are often perceived by consumers as fresher, more flavorful, and more appetizing. FD&C Yellow No. 6, Aluminum Lake provides product developers with a stable orange-yellow pigment that can be used in confectionery, snacks, beverages, baked goods, and other prepared foods to achieve specific aesthetic qualities. The use of lake pigments expands the range of products where colorants can be applied, especially in low-moisture, high-fat, or dry systems where water-soluble dyes are unsuitable. In addition to aesthetic enhancement, consistent coloration can support branding, quality perception, and even consumer expectations for flavor. For example, certain flavors like citrus or fruit flavors are often associated with specific hues, and the addition of a stable lake colorant enables manufacturers to align appearance with sensory expectations. Compared to direct soluble dyes, aluminum lakes are less likely to migrate, bleed, or change appearance in response to formulation variables such as pH or moisture content. This makes them valuable in dry mixes, powdered drink formulations, coatings, tablets, and encapsulated products where long-term stability and resistance to processing conditions are important. The technical functions of FD&C Yellow No. 6 Aluminum Lake focus on delivering reliable color under a range of manufacturing and storage conditions. Its insoluble nature means that it disperses rather than dissolves, preventing unwanted interactions with aqueous components and maintaining homogeneity. This can be particularly important in products where texture and visual consistency are key quality attributes. Although the principal role is color, the additive may also influence how other ingredients interact with light and moisture, contributing to overall product performance in some formulations.

Adi Example Calculation

To illustrate how an acceptable daily intake (ADI) is used, consider a hypothetical adult weighing 70 kilograms. If an expert committee establishes an ADI of 4 milligrams per kilogram of body weight per day for the parent dye Sunset Yellow FCF, this is interpreted as a health-protective level of lifetime daily exposure that does not signal appreciable risk. Under this hypothetical ADI, a 70-kilogram adult could theoretically be exposed to up to 280 milligrams per day without exceeding the safety reference value (4 mg/kg bw/day multiplied by 70 kg = 280 mg/day). This example does not imply that individuals should aim for or seek exposure anywhere near the ADI; instead, it demonstrates how the ADI serves as a benchmark for regulatory assessment. Actual exposure for most consumers through use of foods containing FD&C Yellow No. 6 Aluminum Lake would typically be considerably lower than this calculated value, given the relatively small amounts of color additive used in formulated products. Regulatory bodies use this type of calculation when estimating dietary exposure in population studies to ensure that even high-end consumers remain below the ADI.

Safety And Health Research

The safety evaluation of color additives such as FD&C Yellow No. 6 and its aluminum lake form focuses on toxicological endpoints relevant to chronic dietary exposure. Regulatory bodies review data on absorption, distribution, metabolism, excretion, and toxicological studies to identify potential hazards and establish acceptable exposure levels. The parent dye Sunset Yellow FCF has been reviewed by the Joint FAO/WHO Expert Committee on Food Additives, which considered chronic toxicity and other data in its evaluations. These assessments contribute to defining the acceptable daily intake range applied to the parent compound, which regulators may refer to when considering derivatives used in food. Scientific evaluations consider diverse study types including subchronic and chronic animal studies examining organ system effects, genotoxicity data assessing mutagenic potential, and reproductive and developmental toxicity studies. Though specific data on the aluminum lake form may be less extensive than for the soluble parent dye, regulators generally base safety conclusions on the body of evidence for the chromophore and its metabolic fate, acknowledging that the lake form does not significantly alter systemic exposure. International reviews by expert committees provide context for risk assessment by integrating multiple lines of evidence and applying conservative safety factors to account for uncertainties. The regulatory focus is on ensuring that use levels in foods remain below thresholds that could present concern, based on established acceptable daily intake values. Ongoing monitoring and reevaluation processes allow regulatory agencies to incorporate new research findings and adjust recommendations as needed to maintain protection of public health.

Regulatory Status Worldwide

In the United States, FD&C Yellow No. 6 and its aluminum lake form are addressed through color additive regulations in the Code of Federal Regulations. Certified color additives must meet identity, purity, and batch certification requirements specified by the Food and Drug Administration. While FD&C Yellow No. 6 itself is covered under 21 CFR 74.706 for food use, aluminum lake forms are typically addressed in related sections such as those referenced in part 82 and other applicable standards, with certification requirements ensuring product compliance. Certification involves testing and documentation to verify that each batch meets established specifications before use in food, drugs, and cosmetics. This regulatory framework ensures that lake pigments conform to defined quality and safety parameters consistent with good manufacturing practice. Internationally, Sunset Yellow FCF (INS 110, E110) and its derivatives including aluminum lake forms are evaluated by organizations such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and by the European Food Safety Authority (EFSA). JECFA has evaluated Sunset Yellow FCF and maintained acceptable daily intake recommendations expressed for the parent dye, and such evaluations inform international standards and Codex Alimentarius provisions. In the European Union, Sunset Yellow FCF is assigned the E number E110 and subject to specific conditions of use and maximum permitted levels in defined food categories under EU food additive regulations. Regulatory frameworks in other regions may adopt similar classifications and conditions based on international evaluations and local risk assessments. These worldwide regulatory systems aim to ensure that color additives like FD&C Yellow No. 6, Aluminum Lake are used safely and consistently within defined limits and labeling requirements. They also provide mechanisms for ongoing reevaluation as new toxicological data become available, ensuring that standards reflect up-to-date scientific knowledge.

Taste And Functional Properties

FD&C Yellow No. 6, Aluminum Lake is not intended to impart taste to food products; its principal role is to provide a visual color effect. In formulated systems, lake colorants are typically present at low levels, often below sensory thresholds for taste or odor, so they do not contribute to the overall flavor profile of a finished product. This characteristic allows manufacturers to focus on flavor design independently while using color to enhance appeal and recognition. Functionally, lake colorants like FD&C Yellow No. 6 Aluminum Lake are designed to disperse uniformly throughout dry or semi-solid matrices. Their insoluble nature means they remain physically suspended rather than dissolving, which can influence how light interacts with the product and how the color is perceived by consumers. Lake pigments tend to provide more stable and intense color in applications like coatings, tablets, and powders compared to water-soluble dyes. They also exhibit better resistance to migration and bleeding, which can be critical in multi-component systems or products that undergo temperature and humidity variations during processing or storage. Because lake colorants do not dissolve in water, they are less sensitive to changes in pH or ionic strength that can affect soluble dyes. This stability profile makes them useful in systems where color integrity must be maintained across a range of conditions without affecting other functional attributes of the formulation. While color stability does not directly relate to taste, it supports a consistent sensory experience by ensuring that visual cues align with consumer expectations for flavor and freshness.

Acceptable Daily Intake Explained

An Acceptable Daily Intake (ADI) is a health-based reference value established by expert committees to indicate the amount of a substance that can be consumed daily over a lifetime without appreciable health risk. For color additives such as Sunset Yellow FCF (the parent dye for FD&C Yellow No. 6 Aluminum Lake), international bodies evaluate toxicological data and set an ADI expressed in milligrams per kilogram of body weight per day. The ADI accounts for uncertainties in data by applying safety factors to no-observed-adverse-effect levels observed in animal studies, ensuring a wide margin of safety for human exposure. It is important to note that the ADI is not a recommended intake level but a risk assessment tool to guide regulatory decisions and allowable use levels in food products. Food regulators use the ADI to assess dietary exposure from foods that contain the additive and ensure that typical consumption patterns remain well below the reference value. Because the ADI is based on comprehensive toxicological evaluations, it reflects a conservative estimate that includes safety margins to protect sensitive populations. In practice, actual exposure from consumption of food products containing the color additive is usually much lower than the ADI, indicating a substantial buffer between typical intake and levels associated with potential risk in experimental settings.

Comparison With Similar Additives

Lake colorants are a class of food additives that provide visual color without dissolving in water, offering formulation advantages in low-moisture or high-fat systems. FD&C Yellow No. 6 Aluminum Lake can be compared to other aluminum lake forms such as FD&C Red No. 40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. All these additives are derived from their respective parent dyes and engineered to disperse as pigments in products where soluble dyes would be unsuitable. FD&C Red No. 40 Aluminum Lake delivers a vivid red hue and, like Yellow No. 6 Aluminum Lake, is used in confectionery, coatings, and tablet products where stability and consistent dispersion are desired. FD&C Blue No. 1 Aluminum Lake provides a blue shade for similar applications and likewise offers resistance to bleeding compared to soluble forms. While each colorant varies in chromatic properties and specific application niches, the functional rationale for choosing a lake pigment over a direct dye remains consistent: improved stability in low-moisture, oil-rich, or dry environments. From a regulatory perspective, all these additives are subject to certification and purity specifications that ensure they meet defined standards before use. The parent dyes have also been evaluated for acceptable daily intake levels, and regulators assess dietary exposure accordingly. Product developers often select colorants based on both chromatic needs and formulation constraints, balancing aesthetic goals with stability and regulatory compliance.

Common Food Applications Narrative

FD&C Yellow No. 6, Aluminum Lake is commonly used in a variety of food products where a vibrant orange-yellow color is desired and an insoluble pigment form is advantageous. In confectionery, such as hard candies, gummies, and candy coatings, lake pigments provide stable color that resists bleeding and maintains visual appeal even in dry or low-moisture environments. Snack foods and baked goods also employ this color additive to enhance visual consistency, matching consumer expectations for product appearance and flavor associations. Powdered drink mixes and dessert powders benefit from the use of lake colorants because they disperse uniformly without dissolving, which helps maintain a consistent appearance after preparation. Ready-to-drink beverages, gelatin desserts, and fruit-flavored snacks may also include this pigment where an orange-yellow hue supports flavor cues like citrus, tropical fruit, or savory spice profiles. In foods that contain fats or oils, such as certain snack coatings and baked items, the insoluble nature of the aluminum lake helps prevent color migration and separation, supporting a homogeneous product experience. Beyond traditional food applications, FD&C Yellow No. 6, Aluminum Lake may also be found in nutraceutical tablets, vitamins, and other ingested products where color aids in product differentiation and consumer acceptance. Because it does not dissolve in water, this form of the colorant can be incorporated into compressed tablets and capsules without altering disintegration characteristics. Across these applications, the consistent visual impact of the color additive contributes to branding, quality perception, and alignment with flavor expectations, helping manufacturers achieve target appearance profiles without compromising functional performance.

Safety & Regulations

FDA

  • Notes: Specific CFR approval for the aluminum lake form is inferred from Certified Color Additive listings but not directly confirmed on deep link

EFSA

  • Approved: True
  • E Number: E110
  • Adi Display: 0-4 mg/kg bw
  • Adi Mg Per Kg: 4

JECFA

  • Year: 2011
  • Ins Number: 110
  • Adi Display: 0-4 mg/kg bw
  • Adi Mg Per Kg: 4

Sources

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