FD&C YELLOW NO. 6

CAS: 2783-94-0 COLOR OR COLORING ADJUNCT, FLAVOR ENHANCER, FLAVORING AGENT OR ADJUVANT

FD&C Yellow No. 6, also known as Sunset Yellow FCF and identified by CAS 2783-94-0 and INS 110, is a synthetic food color additive used to impart yellow to orange hues in food, drug, and cosmetic products and subject to certification and regulatory standards in the United States and internationally.

What It Is

FD&C Yellow No. 6 is a synthetic color additive principally composed of the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid, used to provide yellow to orange coloring in many food, beverage, drug, and cosmetic products. In regulatory nomenclature, it is often referred to as Sunset Yellow FCF, Food Yellow 3, and classified as INS 110 in the Codex Alimentarius International Numbering System for Food Additives. The additive functions as a color or coloring adjunct as well as, in some formulations, a flavor enhancer or flavoring adjuvant, although its primary technological role is to impart or adjust color. It is listed in regulatory references including 21 CFR 74.706 for foods, 21 CFR 74.1706 for drugs, and 21 CFR 74.2706 for cosmetics, which describe the identity, allowed uses, and specifications for batches of the certified color. FD&C Yellow No. 6 is a member of the azo dye family, a broad class of synthetic organic dyes characterized by an azo (-N=N-) linkage between aromatic substructures. Its appearance is typically an orange to yellow-orange powder or granules that dissolve readily in water, allowing for consistent dispersion in aqueous-based formulations. As a regulated color additive in the United States, it is subject to batch certification by the U.S. Food and Drug Administration to ensure conformity with identity and purity specifications before it may be introduced into regulated products. In international systems, the additive corresponds to E Number E110 under European Union food additive labeling, and is included under the Codex Alimentarius standards for food colorants, where it is authorized for use in specified food categories at levels consistent with good manufacturing practice. While not a nutrient, FD&C Yellow No. 6 is widely used because it provides stable color effects across a range of food matrices, and its inclusion in product ingredient lists helps manufacturers achieve targeted visual appearance and sensory appeal.

How It Is Made

The manufacturing of FD&C Yellow No. 6 involves classical diazotization and coupling chemistry common to many azo dyes. According to regulatory descriptions, the additive is prepared by diazotizing 4-aminobenzenesulfonic acid with nitrite under acidic conditions to form a diazonium intermediate, which is then coupled with 6-hydroxy-2-naphthalenesulfonic acid to produce the principal disodium salt of the azo compound. This reaction sequence creates the extended conjugated structure responsible for the characteristic orange-yellow color. The resulting product may be isolated, purified, and dried to yield a stable powder or granulate suitable for use as a color additive in foods and other products. The regulatory standard for FD&C Yellow No. 6 specifies the allowable composition and limits for impurities. These include constraints on the content of volatile matter, chlorides, sulfates, water-insoluble matter, and specific subsidiary colorants or residual reactants that may arise from the manufacturing process. Compliance with these specifications is essential for product certification and reflects good manufacturing practice for color additive production. From a quality perspective, producers must manage reaction conditions, purification steps, and analytical testing to meet identity and purity criteria set by regulatory authorities, including limits on heavy metals and other potential contaminants. Batches that meet these identity and specification requirements are certified by the appropriate regulatory body, such as the FDA in the United States, before they may be used in food, drug, or cosmetic applications. This certification process ensures that the material used by formulators is consistent with safety and quality standards required for products intended for human use.

Why It Is Used In Food

FD&C Yellow No. 6 is used in food primarily for its ability to impart appealing yellow to orange hues, which can enhance the visual appeal of products and help standardize appearance across production batches. Color plays an important role in consumer perception, often serving as an indicator of flavor expectations or product quality. For example, the bright yellow-orange color associated with certain beverages, confections, cereals, baked goods, snacks, and dessert mixes can signal flavor profiles or freshness, even though the additive itself does not contribute a nutritive function. In addition to aesthetic enhancement, the additive’s stability and compatibility with other food components make it a practical choice for formulators. It is generally stable under a range of pH conditions typical of many food products, and it dissolves readily in water, allowing uniform distribution in aqueous systems. In combination with other colors, FD&C Yellow No. 6 can be used to achieve specific shades or to offset color changes that occur during processing or storage. While its primary technological function is coloring, in some products components may interact in ways that influence sensory attributes indirectly by affecting how other ingredients are perceived. Manufacturers and product developers often select FD&C Yellow No. 6 because it enables them to meet consumer expectations for product appearance while complying with regulatory requirements for certified color additives. Its use is guided by principles of good manufacturing practice, meaning the quantity used is limited to what is necessary to achieve the intended color effect. This careful application supports both visual quality and adherence to regulatory frameworks governing additive use.

Adi Example Calculation

To illustrate how acceptable daily intake (ADI) might be applied in a hypothetical example, consider an ADI established at 4 mg per kilogram of body weight per day for FD&C Yellow No. 6 by international expert evaluation. For an individual weighing 70 kilograms, the ADI would be calculated by multiplying body weight by the ADI value, resulting in 280 mg per day as the upper amount that could be consumed repeatedly over a lifetime without appreciable health risk, according to this safety benchmark. It is important to emphasize that this calculation is illustrative and does not imply that individuals should aim to consume this amount. Actual exposure from food and beverage sources is typically far lower than the ADI when the additive is used in accordance with regulatory limits and good manufacturing practice. The ADI serves as a reference point for regulators and industry to ensure that cumulative intake from all sources remains within a range considered safe based on toxicological evidence and established safety factors.

Safety And Health Research

Safety evaluations of FD&C Yellow No. 6 have been conducted by major regulatory and scientific bodies to assess potential health effects associated with dietary exposure. The World Health Organization’s Joint FAO/WHO Expert Committee on Food Additives (JECFA) has reviewed toxicological data and established an acceptable daily intake reflecting the margin of safety based on long-term studies and uncertainty factors. This review considers end points such as general toxicity, metabolism, and organ system responses in laboratory models to inform risk assessment and ensure dietary exposures remain within levels deemed not to present health concern. Regulatory authorities also monitor emerging research and toxicology studies that explore specific biological responses under controlled conditions. These evaluations often consider a range of data including absorption, distribution, metabolism, excretion, and potential effects at doses far exceeding typical dietary exposures. By focusing on established toxicological end points and the context of realistic intake levels, regulators aim to ensure that approved uses of FD&C Yellow No. 6 are supported by scientific evidence indicating a reasonable certainty of no harm when consumed consistent with good manufacturing practice and regulatory limits. This body of research and regulatory assessment helps inform labeling requirements, usage conditions, and public communication about the additive. While ongoing scientific inquiry may continue to refine understanding of mechanisms and responses, current global regulatory evaluations support the controlled use of FD&C Yellow No. 6 in foods and other products, with monitoring and reevaluation processes in place to incorporate new data as appropriate.

Regulatory Status Worldwide

FD&C Yellow No. 6 is a regulated color additive with defined status in multiple jurisdictions. In the United States, it is listed as a certifiable color additive for coloring foods under 21 CFR 74.706, which outlines its identity, specifications, and permitted uses, including the requirement that batches be certified by the U.S. Food and Drug Administration before use in food products. Similar listings exist for drug and cosmetic applications under 21 CFR 74.1706 and 21 CFR 74.2706, where the regulatory text authorizes its use in those categories under prescribed conditions. These regulations reflect a longstanding approval for the additive’s use, with specific provisions governing labeling, certification, and compliance with identity and purity criteria as defined in the Code of Federal Regulations. At the international level, FD&C Yellow No. 6 corresponds to Sunset Yellow FCF and is included in the Codex Alimentarius International Numbering System as INS 110. The Codex General Standard for Food Additives (GSFA) establishes maximum permitted levels for the additive across multiple food categories, providing a harmonized framework for its global food use. Similarly, the World Health Organization’s Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated the additive’s safety and established an acceptable daily intake based on toxicological assessments. In the European Union, the additive is identified by E Number E110, and authorities such as the European Food Safety Authority have reviewed and set acceptable daily intake values grounded in scientific data. These global regulatory positions underscore the additive’s recognized status for use when applied within defined safety and usage parameters, with oversight mechanisms ensuring conformity with established standards.

Taste And Functional Properties

FD&C Yellow No. 6 is characterized by its strong tinting power and negligible taste impact at levels used for coloring. When dissolved in water or incorporated into food matrices, the additive contributes a vibrant yellow to orange hue without imparting a distinct flavor, allowing it to fulfill its role as a colorant without altering the intended taste profile of a product. This functional neutrality in taste makes it suitable for use across a wide range of food and beverage applications where visual appeal is desired without flavor interference. From a functional perspective, FD&C Yellow No. 6 exhibits solubility in water and aqueous systems, facilitating its dispersion in beverages, gel systems, sauces, and other products with high moisture content. Its stability across typical food processing conditions, including moderate heat and variations in pH, supports consistent color retention during manufacturing and shelf storage. However, like many azo dyes, its color expression can be influenced by extreme pH conditions or interactions with other formulation components, which may lead to shifts in hue or intensity. Manufacturers consider these properties when selecting and formulating with FD&C Yellow No. 6. Its behavior under different processing conditions and in combination with other additives or ingredients informs decisions about dosage, timing of addition, and potential interactions that could affect final product appearance. These considerations help ensure that the intended visual outcome is achieved while maintaining product quality and sensory characteristics desired by consumers.

Acceptable Daily Intake Explained

Acceptable daily intake (ADI) is a scientific estimate of the amount of a substance that can be consumed daily over a lifetime without appreciable health risk. For FD&C Yellow No. 6, international expert committees such as JECFA have evaluated available toxicological data to derive an ADI that reflects a margin of safety between observed effects in studies and typical human exposures. This ADI is expressed relative to body weight and is meant to guide regulatory limits and exposure assessments. The ADI is not a target intake level or recommended daily amount; rather, it provides a benchmark for safety assessment. Dietary exposure assessments consider the ADI in the context of consumption patterns and use levels in foods to determine whether typical intakes fall well below the ADI. Regulatory bodies use the ADI along with maximum permitted levels in product categories to ensure that cumulative exposure across multiple food sources remains within safe bounds. This framework supports ongoing protection of public health while enabling the use of color additives like FD&C Yellow No. 6 under conditions consistent with good manufacturing practice.

Comparison With Similar Additives

When comparing FD&C Yellow No. 6 with other certified color additives such as FD&C Yellow No. 5 (Tartrazine) or FD&C Red No. 40 (Allura Red AC), several aspects can be considered. All three are synthetic azo dyes widely used to impart vivid color effects in food and beverage products. FD&C Yellow No. 5 typically provides a bright yellow hue, whereas FD&C Yellow No. 6 offers a more orange-yellow shade, and FD&C Red No. 40 imparts red tones. These color profiles influence their selection based on desired final product appearance. All three additives are subject to regulatory evaluation and certification processes to ensure compliance with identity, purity, and safety standards. Acceptable daily intake levels may differ among them based on toxicological data and risk assessments performed by authorities. For example, international evaluations and specified ADIs reflect differences in the safety databases and conclusions drawn by expert panels. In formulation practice, manufacturers choose among these colorants based on the specific hue needed, regulatory status in target markets, and functional considerations such as solubility, stability, and interactions with other ingredients. While serving similar technological functions, each certified color additive has a distinct regulatory history and safety profile that guides its use within established standards.

Common Food Applications Narrative

FD&C Yellow No. 6 finds application in a diverse array of food and beverage products where visual appeal is an important aspect of consumer acceptance. In many breakfast cereals, snack foods, baked goods, dessert powders, and gelatins, the yellow to orange coloration produced by this additive aligns with consumer expectations for specific flavors or product categories. The vibrant hues can make products more visually enticing on store shelves and in prepared servings, contributing to the overall sensory experience. In beverages such as fruit-flavored drinks, sodas, and ready-to-drink mixes, FD&C Yellow No. 6 is used to achieve color consistency across batches and help products stand out in competitive markets. Its solubility in aqueous systems allows for good dispersion in drinks and liquid formulations without affecting clarity or other desirable visual characteristics. The additive may also be found in dessert mixes, confectionery items, sauces, and other culinary applications where specific color cues signal flavor or texture expectations to consumers. The use of FD&C Yellow No. 6 in these products is guided by regulatory frameworks and industry standards that emphasize safe use and appropriate labeling. Across different food categories, formulators apply the additive at levels consistent with good manufacturing practice to achieve the desired color effect without exceeding what is necessary for functional impact. This approach supports both visual quality and adherence to safety and regulatory requirements, ensuring products meet consumer expectations while aligning with oversight standards.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 74.706

EFSA

  • Approved: True
  • E Number: E110
  • Adi Display: 4 mg/kg bw/day
  • 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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