FD&C YELLOW NO. 5

CAS: 1934-21-0 COLOR OR COLORING ADJUNCT, FLAVOR ENHANCER, FLAVORING AGENT OR ADJUVANT

FD&C Yellow No. 5, commonly known as tartrazine, is a synthetic lemon-yellow monoazo dye used primarily as a colorant in foods and other products. It is evaluated and permitted for use in many jurisdictions with specific regulatory requirements.

What It Is

FD&C Yellow No. 5, also known by the common name tartrazine and indexed by INS number 102, is a synthetic lemon-yellow azo dye used widely as a color additive in a range of consumer products. It belongs to the class of monoazo colorants and is identified chemically by the CAS number 1934-21-0. As a color adjunct, it provides yellow hues when added to something that does not naturally possess that color, assisting manufacturers in achieving consistent and visually appealing products. Beyond its role as a color additive, it has historically been used as a flavor enhancer or flavoring adjunct in formulations where color and taste interplay in consumer acceptance. FD&C Yellow No. 5 is often encountered in combination with other additives to achieve desired shades and stability in various matrices. Tartrazine’s identification includes multiple synonyms that reflect its chemical structure and classification, including C.I. Acid Yellow 23 and C.I. Food Yellow 4, each of which describes the color index designation recognized in regulatory specifications. As an azo compound, its structure features a nitrogen double-bonded linkage characteristic of dyes in this family. While its primary application is color, its presence in foods and products where flavoring performance is also important underscores the multifaceted roles that color additives can occupy in formulation science. The use of FD&C Yellow No. 5 has been evaluated by international expert bodies, and its authorized uses are specified with regulatory guidelines that cover identity, purity, and how it is declared on product labels. Understanding what tartrazine is and how it is classified helps in interpreting its use in foods, pharmaceuticals, and other consumer goods.

How It Is Made

FD&C Yellow No. 5 (tartrazine) is synthesized chemically through a multi-step process typical of azo dye production, starting from aromatic precursors that undergo diazotization and coupling reactions to form the characteristic azo bond. The process generally involves the reaction of sulfanilic acid with derivatives of pyrazolone under controlled conditions to produce the trisodium salt of tartrazine. At an industrial scale, manufacturing also includes purification steps designed to meet stringent identity and purity specifications set by regulatory authorities. Once synthesized, the dye undergoes refining procedures to remove impurities and ensure that the material meets the chemical and physical criteria established for food-grade colorants. Regulatory specifications often define acceptable levels for subsidiary colors and limits on metals and other contaminants. In the United States and other regions, each batch of certifiable tartrazine must be tested against these specifications and, in some cases, undergo certification procedures to ensure compliance with identity, purity, and safety requirements. The overall manufacturing framework for tartrazine is analogous to other synthetic colorants, whereby high-purity precursors are reacted under conditions that favor consistent product quality. Final bulk material is formulated into forms usable by food, beverage, and cosmetic manufacturers. Because tartrazine is a synthetic colorant, the entire production chain is subject to quality control and regulatory oversight to maintain compliance with applicable guidelines.

Why It Is Used In Food

The primary reason FD&C Yellow No. 5 is used in food is to impart or restore a bright, consistent yellow color to products that may otherwise lack appealing visual characteristics. Color is a key aspect of consumer perception, and consistent hues can enhance the attractiveness and uniformity of items such as beverages, confections, baked goods, and dairy products. The addition of a colorant like tartrazine helps manufacturers achieve predictable visual outcomes across batches. Beyond aesthetics, color additives play a role in helping consumers identify flavors or flavor profiles; for example, yellow hues may be associated with citrus or tropical flavors. Although FD&C Yellow No. 5’s technological function is primarily color, in some formulations it can support broader flavor presentation goals by bringing visual and sensory attributes into harmony. Its use is driven by formulations where the visual impact is considered important to product appeal, and where alternative color sources may not provide the required shade, stability, or cost efficiency. Because tartrazine is water-soluble and compatible with many food matrices, it’s suitable for a wide range of applications, including beverages and water-based systems. Its compatibility with other additives, such as additional colors or stabilizers, further expands its utility in complex product formulations. Regulatory frameworks ensure that its use in food remains within defined safety parameters.

Adi Example Calculation

To illustrate how an acceptable daily intake (ADI) might be applied in a hypothetical context, imagine an ADI expressed as a conservative upper bound common in international evaluations. For example, if the established range allowed for risk assessment is up to a certain number of milligrams per kilogram of body weight per day, this means that a person weighing a given number of kilograms could theoretically consume that value multiplied by their body weight daily without exceeding the ADI. Such an example is intended for conceptual understanding only; it does not represent a recommended intake level for any individual. Hypothetical calculations typically involve multiplying the upper bound of the ADI by the body weight to estimate a daily exposure level that would be considered within acceptable limits. Because ADIs are derived with large safety factors included, actual intake from foods formulated with this additive is often well below these illustrative values. The use of an ADI for regulatory assessment serves as a tool to compare estimated exposures across populations relative to the reference level defined by expert committees.

Safety And Health Research

Regulatory and scientific assessments of FD&C Yellow No. 5 focus on understanding potential health concerns associated with exposure to this color additive. International expert bodies, including the Joint FAO/WHO Expert Committee on Food Additives (JECFA), have reviewed toxicological data and established acceptable daily intake (ADI) ranges based on available evidence. JECFA’s evaluation considered animal studies and uncertainty factors to define intake levels that would not be expected to raise safety concerns for the general population. Such evaluations typically examine endpoints such as body weight changes in chronic studies and apply uncertainty factors to account for variability between and within species. In addition to international evaluations, regional bodies like the European Food Safety Authority (EFSA) have re-evaluated the body of evidence concerning tartrazine’s safety within their regulatory contexts. These assessments consider published studies and data relevant to human exposure levels. While some research literature discusses potential associations between azo dyes and hypersensitivity reactions in susceptible individuals, regulatory evaluations focus on overall risk assessments drawing on a range of toxicological data and exposure estimates. Safety research encompasses both hazard identification and exposure assessment components to inform risk management decisions. Regulatory authorities use these assessments to define appropriate conditions and labeling requirements to support the safe use of tartrazine in foods and other products.

Regulatory Status Worldwide

In the United States, FD&C Yellow No. 5 is subject to regulation as a color additive in food, drugs, and cosmetics. Specific listing regulations define its permitted uses and labeling requirements; for example, labeling for foods containing this color additive must explicitly declare "FD&C Yellow No. 5" among the product ingredients. U.S. regulations also govern batch certification and purity specifications for certifiable color additives. The Code of Federal Regulations includes sections describing the conditions under which FD&C Yellow No. 5 may be used and how it must be labeled. Internationally, tartrazine is recognized by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and included in international food additive specifications with an INS number of 102, reflecting its functional class as a colorant. JECFA’s evaluations have informed regulatory decisions in multiple jurisdictions. In the European Union, the additive is known by the E number E102, and its use has been re-evaluated by the European Food Safety Authority (EFSA). EFSA’s assessments consider available scientific data to determine whether continued authorization and any use limitations are appropriate within the EU. Many other countries reference Codex Alimentarius specifications when establishing their national food additive rules. Regulatory frameworks vary by jurisdiction, but all include safeguards related to identity, purity, and use conditions. Labels and ingredient declarations are tailored to local requirements to ensure that consumers are informed about the presence of this additive in products.

Taste And Functional Properties

FD&C Yellow No. 5 itself does not impart a distinct taste at levels typically used for coloring, and any sensory impact on flavor is considered minimal. Its primary sensory role is visual rather than gustatory, helping to deliver bright, consistent yellow hues that align with consumer expectations for appearance. The additive’s solubility in water-based systems supports its use in beverages and aqueous food formulations, where ease of incorporation and uniform dispersion are important. Functionally, tartrazine is stable under many processing conditions, retaining its color intensity across typical thermal treatments and within a range of pH environments encountered in foods. Its performance can be influenced by formulation conditions, including the presence of other colors or stabilizers, which manufacturers consider when developing products intended to meet specific visual and stability criteria. Tartrazine’s functional behavior makes it a reliable choice for applications where predictable color performance is needed. Because its taste impact is minimal, it is often paired with flavoring ingredients without interfering with the intended sensory profile. Its properties support its broad acceptance in food formulation practice.

Acceptable Daily Intake Explained

An acceptable daily intake (ADI) represents a level of daily exposure to a substance that regulatory and scientific bodies consider to be without appreciable risk over a lifetime, based on current evidence. For color additives like FD&C Yellow No. 5, expert committees evaluate available toxicological data from animal studies and apply uncertainty factors to account for differences between species and among individuals, arriving at an ADI range. The ADI is a conservative estimate intended for risk assessment and regulatory purposes, not a recommended consumption target for individuals. Because ADI values are set with broad safety margins, typical dietary exposures to approved food colorants are generally well below these thresholds when used as permitted in regulated products. The ADI provides context for regulators and manufacturers to assess whether typical use levels in foods might approach or exceed levels of potential concern. It’s important to note that an ADI is not a measure of toxicity at normal use levels but rather a reference point for evaluating safety across population exposures.

Comparison With Similar Additives

When comparing FD&C Yellow No. 5 with other food color additives, it’s useful to consider additives with similar functional roles. Another common synthetic colorant is FD&C Yellow No. 6 (also known by its E number in some regions), which provides an orange-yellow shade and is used where that specific hue complements flavor or product appearance. Like FD&C Yellow No. 5, Yellow No. 6 is subject to regulatory evaluation and permitted uses defined by regional authorities. Natural colorants, such as beta-carotene, also provide yellow to orange hues but differ from synthetic colorants in their source and regulatory classification. Natural alternatives may appeal to formulators and consumers seeking plant-derived ingredients, though they can exhibit different stability or sensitivity to processing conditions. Comparisons among colorants consider functional attributes such as shade, solubility, and stability, as well as regulatory status and consumer preference trends. Across these comparisons, the choice of additive depends on the desired visual outcome, compatibility with other ingredients, and compliance with regional regulations. Each additive’s safety profile is assessed independently by expert bodies to ensure authorized uses remain within defined safety frameworks.

Common Food Applications Narrative

FD&C Yellow No. 5 appears in a wide variety of food and beverage products where a bright yellow hue is desirable. For example, it is commonly used in beverages, where its water solubility supports incorporation into clear and colored drinks alike. In confectionery, tartrazine helps deliver visually appealing yellow tones in candies, gummies, and icings, reinforcing flavor expectations and drawing consumer attention. Baked goods and frostings also benefit from the predictable color contribution afforded by this additive. Dairy products, such as flavored yogurts and frozen treats, may include FD&C Yellow No. 5 to achieve consistent yellow shading that complements fruit or tropical flavorings. Similarly, processed snacks and savory items that incorporate sauces or dressings often utilize this colorant to maintain brand-consistent coloration. Because it dissolves well and blends seamlessly in many matrices, its use extends to powdered mixes, gelatin desserts, and certain prepared foods. In each application, the use of FD&C Yellow No. 5 is governed by regulatory requirements that specify how it must be labeled and used in products intended for human consumption. Manufacturers balance visual impact with compliance to ensure that products containing this additive are both appealing and compliant with applicable standards.

Safety & Regulations

FDA

  • Approved: True
  • Regulation: 21 CFR 74.1705 and 21 CFR 74.705

EFSA

  • Notes: Numeric ADI not set due to varying evaluations; specific ADI values referenced internationally.
  • Approved: True
  • E Number: E102

JECFA

  • Year: 2016
  • Ins Number: 102
  • Adi Display: 0-10 mg per kg bw

Sources

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