Color Additives in Food: FDA Regulation, Categories, and Certification

Color additives are used in food for many reasons, including: to offset color loss due to exposure to light, air, extremes of temperature, moisture and storage conditions; to correct natural variations in color; to enhance colors that occur naturally; and to provide color to colorless and "fun" foods. The U.S. Food and Drug Administration (FDA) regulations require evidence that a color additive is safe at its intended level of use before it may be added to foods. When the FDA approves a color additive for use in food, our regulations specify: the food types in which it can be used, the maximum amounts allowed to be used, and how the color additive should be identified on the food label. The color additives the FDA permits for use in food fall into two categories: those subject to certification and those exempt from certification. Both must meet the same safety standards before approval for use in food. Certifiable color additives are synthetically produced (or man-made) and are used widely because they impart an intense, uniform color, are less costly, and blend more easily to create a variety of hues. There are seven certified color additives approved for use in food, known as "FD&C" colors because they may also be used in drugs and cosmetics — for example, FD&C Yellow No. 6. See the chart for the complete list. Color additives exempt from certification generally include dyes and pigments derived from natural sources such as vegetables, minerals or animals. Examples of exempt color additives include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel (yellow to tan), beta-carotene (yellow to orange) and grape skin extract (red or purple). The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that a substance that imparts color is a color additive and is subject to premarket approval requirements, unless the substance is used solely for a purpose other than coloring and is of no consequence to the marketability of the product. In assessing the safety of a substance and whether it should be approved, the FDA considers: the composition and properties of the substance, the amount that would typically be consumed, immediate and long-term health effects, and the availability of analytical methods to determine its purity and acceptable levels of impurities. The assessment determines an appropriate use level that incorporates a built-in safety margin — an additional factor that accounts for the variability and uncertainty reflected in the data when evaluating consumption levels, to ensure the proposed use is safe. In other words, the approved use level is far below the level expected to have any adverse effect. The FDA consults with other federal agencies when reviewing color additives intended for products such as meat and poultry or alcoholic beverages. Because of the inherent limitations of science, the FDA can never be absolutely certain of the absence of any risk from the use of any substance. Therefore, the FDA must determine, based on the best science available, whether there is a reasonable certainty that consumers will not be harmed when a color additive is used as proposed. The FDA will not approve the use of a color additive found to induce cancer in humans or animals. If a color additive is approved, the FDA issues regulations that may include the food types in which it may be used, the maximum amounts to be used, how it should be labeled for product manufacturers who market it, and whether batch certification is required. Levels used in food are generally limited to the amount needed to achieve the intended effect. If new evidence suggests that a product already in use may be unsafe, or if consumption levels change enough to warrant re-evaluation, federal authorities may prohibit its use or conduct further studies to determine whether its use can still be considered safe. Listed color additives All color additives the FDA requires to be listed fall into two categories: Color additives subject to batch certification are generally synthetic organic dyes, lakes or pigments. Color additives used in food are chemically classified as azo, xanthene, triphenylmethane and indigoid dyes. Although certifiable color additives are known as coal-tar colors because of their traditional source, today they are mostly synthesized from raw materials obtained from petroleum or coal. Straight color additives (both dyes and pigments) subject to batch certification are listed in 21 CFR Part 74, and lakes subject to batch certification are listed in 21 CFR Part 74 or 21 CFR Part 82. Color additives exempt from certification generally include colorants derived from plant or mineral sources. Cochineal extract (and its lake, carmine) is derived from an insect. Color additives exempt from certification must meet the identity and purity specifications and use limitations described in their listing regulations. Users of these color additives are responsible for ensuring the color additive complies with the listing regulation. Color additives exempt from certification are listed in 21 CFR Part 73. Table 1 gives a complete list of all color additives permitted for use in food. No Generally Recognized as Safe (GRAS) provision for color additives The Federal Food, Drug, and Cosmetic Act (FD&C Act) contains a provision under which certain substances fall within the definition of a food additive if they are generally recognized as safe (GRAS) for their intended use. However, this provision does not apply to color additives. For example, soy leghemoglobin, used in uncooked ground-beef analog products, was the subject of a GRAS notification and, because of the way it is used and its effect on food, was also classified as a color additive. For more information on the GRAS notification process, visit the FDA website. Color additive certification Color additive certification is the FDA's process for ensuring that a newly produced batch of a certifiable color additive meets the identity and specification requirements in its listing regulation. In fiscal year 2022, the FDA certified a total of 28.1 million pounds of color additives, most of which were used in food. Color certification reports are available on the FDA website. The decision on whether batch certification is required is made when the agency reviews a petition requesting that a color additive be listed. Certain color additives may contain impurities of toxicological significance that could adversely affect human health. Batch certification is required when control of the composition is needed to protect public health. Title 21 of the Code of Federal Regulations, Part 80, describes in detail the requirements for color additive certification, as well as storage, fees, recordkeeping and inspection for owners and manufacturers. Regulations in 21 CFR 70.25 set out labeling requirements for color additive batches before and after certification. Under the certification process, a sample of each batch of a certifiable color additive produced must be sent to the FDA's Color Certification division, accompanied by a "request for certification" providing information about the batch, including the name of the color additive, the manufacturer's name, the batch weight, the storage conditions of the batch, and the intended use for certification. The FDA charges a certification fee based on batch weight. Before certification, the batch may not be used in food, drug, cosmetic or medical-device products, and must be stored separately from certified batches. Upon receiving a sample, FDA personnel evaluate its appearance and perform a chemical analysis. At least 10 analyses are conducted, including purity (total color content), moisture, residual salts, unreacted intermediates, colored impurities other than the principal color (called subsidiary colors), any other specified impurities, and the heavy metals lead, arsenic and mercury. Evaluation and analysis usually take fewer than five business days. The results are reviewed to determine whether the batch meets the identity and specifications described in the color additive listing regulation. If the sample is found to meet these requirements, the FDA issues a certificate for the batch stating the color additive, the batch weight, the certified use of the color additive, the name and address of the owner, and other necessary information. The FDA also assigns the batch a unique certification lot number, and the batch name is changed — for example, a batch of "tartrazine" becomes "FD&C Yellow No. 5." The analytical and information portions of the certification program have been automated as much as possible. Currently, an online web system allows color additive manufacturers to submit and access information about individual samples, including receipt of the FDA's certificate. Owners of certified batches are subject to FDA inspection of their premises. During these inspections, the FDA reviews color additive use records and draws samples from certified batches for analysis to compare with the FDA's original results. The color additive petition review process In evaluating the safety of a new color additive or a new use of an already-listed color additive, the FDA considers the following: the amount likely to be consumed or the exposure resulting from use of the color additive, cumulative effects in the diet, the safety factor, and the availability of analytical methods to determine its purity and acceptable levels of impurities. Any interested person may petition the FDA to use a new color additive, or to amend the listing of a color additive for a new use. A petitioner for a new color additive must provide the following information: the identity of the proposed color additive physical, chemical and biological properties chemical specifications a description of the manufacturing process stability data intended uses and limitations labeling tolerances and limitations the analytical method used to enforce the chemical specifications the analytical method used to determine the color additive in the product identification and determination of any substance formed in or on the product as a result of using the color additive safety studies an estimate of probable exposure a proposed regulation a proposed exemption from batch certification an environmental assessment or claim of categorical exclusion The petitioner must submit data demonstrating the safety and suitability of the new color additive or new use. The FDA then evaluates the data in the petition, public comments on the petition, and other relevant data in FDA files. After approving a petition, the FDA issues a new listing regulation or amends an existing one for the new color additive or new use. Titles 70 and 71 of the Code of Federal Regulations describe in detail the process for submitting a petition, including the format, administrative requirements, and required information and data. The data supporting a color additive petition will vary depending on whether the petition is for a new color additive or a new use of an already-listed color additive, the proposed use level and type, and the amount of color additive and its impurities that may enter body tissues. The application process is also described on the FDA website, along with information on recently listed color additives and pending color additive petitions. Once a new color additive is listed, the FDA continuously monitors its safe use to ensure new data and safety information are taken into account. Historically, this activity has led to regulatory changes to color additives necessary to protect public health. The FDA manages and maintains a public inventory listing all color additive petitions under active FDA review or submitted but not activated due to deficiencies found during FDA review. Enforcement of color additive regulations When an FDA investigation determines that a color additive violation has occurred, the agency can take various actions to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act) and protect public health. If the responsible company does not act voluntarily (for example, a product recall) to correct the problem, the FDA has several advisory, administrative and judicial options, including warning letters, detention, issuance of import alerts and seizure. Some of the FDA's color additive enforcement actions can be found on the FDA's "Color Additives Compliance and Enforcement" page. The FDA has issued warning letters for undeclared FD&C Yellow No. 6 in dehydrated papaya; undeclared FD&C Red No. 40 and FD&C Yellow No. 6 in baked goods; and undeclared FD&C Blue No. 1 and FD&C Yellow No. 5 in noodle products. The FDA has also reported recalls for undeclared FD&C Red No. 40 and misdeclared FD&C Yellow No. 6 in bottled food coloring, and for the unapproved color additive Ponceau 4R in strawberry filling. The FDA frequently provides guidance on the proper use of color additives. One example of a long-standing policy dating from the early 20th century concerns the sale of the small silver balls, or "silver dragées," used to decorate cookies, cakes and the like. As expressed in a Compliance Policy Guide (CPG), "when the small silver balls known as 'silver dragées' are used exclusively to decorate cakes, and their consumption as confectionery can be avoided under the conditions of use, they are not considered a food or confectionery." The FDA also advises home and commercial bakers to avoid using luster dusts and powdered products to decorate cakes and other foods unless those products are specifically manufactured as edible. In summary, federal regulation of food color additives is long-standing and remains an important program by which the FDA ensures that consumers receive safe and properly labeled food. Historical perspective: the foundation of current regulations Natural colors from vegetable and mineral sources were used in antiquity to color food, drugs and cosmetics. Paprika, turmeric, saffron, oxides of iron and lead, and copper sulfate are some examples. Early Egyptians used artificial colors in cosmetics and hair dyes. Wine has been artificially colored since at least 300 B.C. In 1856, William Henry Perkin discovered the first synthetic organic dye, called mauveine. The discovery of similar dyes followed, and they were soon used to color food, drugs and cosmetics. Because these dyes were originally produced from by-products of coal processing, they became known as "coal-tar colors." Federal oversight of food color additives began in the 1880s. The evaluation of coloring ingredients in food was one of the earliest public initiatives undertaken in the United States, and in 1881 the Division of Chemistry of the U.S. Department of Agriculture (USDA) began studying the use of colors in food. Butter and cheese were the first foods for which the federal government authorized the use of artificial colors. By 1900, many foods, drugs and cosmetics on the U.S. market contained artificial colors. However, not all color additives were harmless, and some were used to mask inferior or defective food. A careful evaluation of the chemicals used to color food at the time revealed the addition of many blatantly toxic substances, such as lead, arsenic and mercury. In many cases, the toxicity of the starting materials used to synthesize color additives was well known, and they could be toxins, irritants, sensitizers or carcinogens.