Color additives are used in foods for many reasons, including to:
- offset color loss due to exposure to light, air, temperature extremes, moisture and storage conditions,
- correct natural variations in color,
- enhance colors that occur naturally, and
- provide color to colorless and "fun" foods.
The FDA’s 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 the use of a color additive in foods, our regulations specify:
- the types of foods in which it can be used,
- any maximum amounts allowed to be used, and
- how the color additive is to be declared on the food label.
The FDA's permitted food colors are classified as subject to certification or exempt from certification, both of which must meet the same safety standard prior to their approval for use in foods.
- Certified color additives are synthetically produced (or human made) and used widely because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues. There are seven certified color additives approved for use in foods called “FD&C” color additives because they also may be used in drugs and cosmetics. For example, FD&C Yellow No. 6. See chart for complete list.
- Color additives that are exempt from certification generally include dyes and pigments derived from natural sources such as vegetables, minerals, or animals. Examples of certification 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 is capable of imparting color is a color additive and is subject to premarket approval requirements unless the substance is used in a product solely for a purpose other than coloring and is clearly unimportant to the marketability of the product.
When evaluating the safety of a substance and whether it should be approved, the FDA considers the:
- composition and properties of the substance,
- amount that would typically be consumed,
- immediate and long-term health effects, and
- availability of analytical methods for determining its purity and acceptable levels of impurities.
The evaluation determines an appropriate level of use that includes a built-in safety margin – an additional factor that considers the variability and uncertainty reflected in data when evaluating the level of consumption to ensure the proposed use is safe. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect. The FDA consults with other federal agencies during the review process for color additives that are proposed for use in products such as meat and poultry or alcoholic beverages.
Because of 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 - if there is a reasonable certainty of no harm to consumers when a color additive is used as proposed. The FDA does not approve the use of a color additive that is found to induce cancer in people or animals.
If a color additive is approved, the FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts to be used, how it should be labeled for marketing to product manufacturers, and whether it requires batch certification. The level used in foods is usually limited to the amount necessary to achieve the desired effect.
If new evidence suggests that a product already in use may be unsafe, or if consumption levels have changed enough to require another look, federal authorities may prohibit its use or conduct further studies to determine if the use can still be considered safe.
Listed Color Additives
All color additives required to be listed by the FDA fall into two categories:
- Color additives subject to batch certification are generally synthetic organic dyes, lakes, or pigments. Those for food use are chemically classified as azo, xanthene, triphenylmethane, and indigoid dyes. Although certifiable color additives have been called coal-tar colors because of their traditional origins, today they are synthesized mainly from raw materials obtained from petroleum or coal. Straight colors subject to batch certification (which include dyes and pigments) are listed in 21 CFR part 74 and lakes subject to batch certification are listed in either 21 CFR part 74 or 21 CFR part 82.
- Color additives exempt from certification generally include those derived from plant or mineral sources. One, cochineal extract (and its lake, carmine), is derived from an insect. Certification exempt color additives must comply with the identity and purity specifications and use limitations described in their listing regulations. Users of these color additives are responsible for ensuring that the color additives comply with the listing regulations. Color additives exempt from certification are listed in 21 CFR part 73. Table 1 gives the complete list of color additives permitted for use in foods.
There is no Generally Recognized As Safe (GRAS) Provision for Color Additives
The FD&C Act has a provision for some substances within the definition of a food additive if they are GRAS for their intended uses. Such a provision does not apply to color additives. For example, soy leghemoglobin, used in uncooked ground beef analogue products, was the subject of a GRAS notice and is also listed as a color additive based on how it is used and its effect on the food. More information on the GRAS notification process may be found on the FDA's web site.
Color Additive Certification
Color additive certification is the process by which the FDA assures that newly manufactured batches of certifiable color additives meet the identity and specification requirements of their listing regulations. During fiscal year 2022, FDA certified batches representing a total of 28.1 million pounds of color additives, much of it for food uses. Color Certification Reports are available on the FDA's web site.
The decision about the need for batch certification is made during the agency's review of a petition requesting a listing for the color additive. Some color additives may contain impurities of toxicological concern, which can have an adverse impact on human health. Batch certification is required when the composition needs to be controlled to protect the public health.
The requirements for color additive certification, as well as storage, fees, recordkeeping, and inspections for owners and manufacturers, are described in detail in 21 CFR part 80. Regulations in 21 CFR part 70.25 prescribe labeling requirements for color additive batches before and after certification. Under the certification process, a sample from each manufactured batch of a certifiable color additive must be sent to the FDA's Color Certification Branch accompanied by a "Request for Certification" that provides information about the batch including the name of the color additive, the name of the manufacturer, the batch weight, storage conditions for the batch, and the use for which it is being certified. The FDA charges a fee for certification based on the batch weight. Prior to certification, the batch cannot be used in food, drug, cosmetic, or medical device products and must be stored separately from batches already certified.
Upon receipt of the sample, the FDA personnel evaluate its physical appearance and chemically analyze it. At least 10 analyses are performed, for purity (total color content), moisture, residual salts, unreacted intermediates, colored impurities other than the main color (called subsidiary colors), any other specified impurities, and the heavy metals lead, arsenic, and mercury. The evaluation and analyses typically take less than five working days. The results are reviewed for compliance with the identity and specifications described in the listing regulation for the color additive. If the sample is found to meet these requirements, the FDA issues a certificate for the batch that identifies the color additive, the batch weight, the uses for which the color additive is certified, the name and address of the owner, and other information as required. The FDA also assigns a unique certification lot number for the batch and the name of the batch changes. For example, a batch of "tartrazine" becomes "FD&C Yellow No. 5."
Analytical and informational components of the certification program have been automated to the fullest extent possible. Currently, an on-line web-based system allows color additive manufacturers to submit and access information about individual samples, including receipt of the FDA's certificates. Owners of certified batches are subject to the FDA inspections of their establishments. During these inspections, the FDA examines records of use of the color additives and takes samples from certified batches for analysis for comparison with the FDA's original results.
Color Additive Petition Review Process
When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers such factors as probable consumption or exposure from its use, cumulative effect in the diet, safety factors, and the availability of analytical methods for determining its purity and acceptable levels of impurities.
Any interested person may petition the FDA for the use of a new color additive or to amend the listing of a color additive for a new use. The petitioner for a new color additive must provide information on the following:
- Identity of the proposed color additive
- Physical, chemical, and biological properties
- Chemical specifications
- Manufacturing process description
- Stability data
- Intended uses and restrictions
- Tolerances and limitations
- Analytical methods for enforcing chemical specifications
- Analytical methods for determination of the color additive in products
- Identification and determination of any substance formed in or on products because of the use of the color additive
- Safety studies
- Estimate of probable exposure
- Proposed regulation
- Proposed exemption from batch certification
- An environmental assessment or claim for categorical exclusion
The petitioner must submit data demonstrating the safety and suitability of the new color additive or new use. The FDA will then evaluate the data in the petition, public comments to the petition, and other relevant data in the FDA's files.
Upon approval of the petition, the FDA will issue a new listing regulation or alter an existing regulation for the new color additive or new use. The process for submitting petitions is described in detail in 21 CFR parts 70 and 71, which describe the format, the administrative requirements, and the information and data required. The data that are appropriate for support of a color additive petition will vary depending on whether the petition is for a new color additive or for a new use for a listed color additive, the level and type of use of the proposed color additive, and the amount of color additive and its impurities that may enter body tissues. The petition process also is described on the FDA's web site and provides information on recently listed color additives and pending color additive petitions. Once a new color additive is listed, the FDA continually monitors its safe use, assuring the consideration of new data and safety information. Historically, this activity has resulted in regulatory changes for color additives that were necessary to protect the public health.
The FDA manages and maintains a public inventory where we list all of the color additive petitions under active FDA review or that are filed but not active because deficiencies were identified during the FDA’s review.
Enforcement of Color Additive Regulations
When the FDA investigation determines that a color additive violation has occurred, the agency can take a number of actions to enforce the FD&C Act and to protect the public health. In the absence of voluntary action (for example, product recall) by the responsible firm to correct the problem, the FDA has several advisory, administrative, and judicial options which include warning letters, detentions, issuance of import alerts, and seizures.
Some of the FDA's color additive enforcement actions may be found on the agency's Enforcement News page. The FDA has sent warning letters for undeclared FD&C Yellow No. 6 in dehydrated papaya, for undeclared FD&C Red No. 40 and FD&C Yellow No. 6 in bakery products, and for undeclared FD&C Blue No. 1 and FD&C Yellow No. 5 in noodle products. The FDA also has reported recalls for undeclared FD&C Red No. 40 and incorrectly declared FD&C Yellow No. 6 in bottled food color and for presence of the unapproved color additive Ponceau 4R in strawberry filling.
The FDA frequently offers guidance on the appropriate use of color additives. One example of a long-standing policy since the early 1900s concerns the use of small silver balls or "silver dragees" sold for decorating cookies, cakes, etc. As expressed in a Compliance Policy Guide (CPG), "When small silver balls known as 'silver dragees' are sold exclusively for decorating cakes and are used under conditions which preclude their consumption as confectionery, they are not considered to be in the category of a food or confectionery."
The FDA has also advised home and commercial bakers to avoid using glitter and dust products to decorate cakes and other food items unless the products are specifically manufactured to be edible.
In summary, the federal regulation of color additives has a long history and remains an important program for the FDA in assuring that consumers have safe and properly labeled products.
Historical Perspectives: The Basis for Current Regulations
Naturally occurring color additives from vegetable and mineral sources were used to color foods, drugs, and cosmetics in ancient times. Paprika, turmeric, saffron, iron and lead oxides, and copper sulfate are some examples. The early Egyptians used artificial colors in cosmetics and hair dyes. Wine was artificially colored beginning in at least 300 BC.
In 1856, William Henry Perkin discovered the first synthetic organic dye, called mauve. Discoveries of similar dyes soon followed, and they quickly became used to color foods, drugs, and cosmetics. Because these dyes were first produced from by-products of coal processing, they were known as "coal-tar colors."
Federal oversight of color additives began in the 1880s. The assessment of color-imparting ingredients in foods was among the first public initiatives undertaken by the U.S. when, in 1881, the U.S. Department of Agriculture's (USDA) Bureau of Chemistry began research on the use of colors in food. Butter and cheese were the first foods for which the federal government authorized the use of artificial coloring.
By 1900, many foods, drugs, and cosmetics available in the U.S. were artificially colored. However, not all of the coloring agents were harmless, and some were being used to hide inferior or defective foods. A careful assessment of the chemicals used for coloring foods at the time found many blatantly poisonous materials such as lead, arsenic, and mercury being added. In many cases, the toxicities of the starting materials for synthesizing coloring agents were well known and could be toxins, irritants, sensitizers, or carcinogens.
In 1906, Congress passed the Food and Drugs Act, which prohibited the use of poisonous or deleterious colors in confectionery and the coloring or staining of food to conceal damage or inferiority. The USDA had initial enforcement authority for this act. In 1907, the USDA issued Food Inspection Decision (F.I.D.) 76, which contained a list of seven straight colors approved for use in food. Subsequent F.I.D.'s in the early part of the century established a voluntary certification program and listed new colors.
In 1927, responsibility for enforcing the Food and Drugs Act of 1906 was given to the newly established FDA. The agency was first called the Food, Drug, and Insecticide Administration and was given its current name in 1930. By 1931, there were 15 straight colors approved for use in foods, including six of the seven in use today: FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigotine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Yellow No. 5 (Tartrazine), and FD&C Yellow No. 6 (Sunset Yellow FCF).
In the 1920s and 1930s, it became clear that the Food and Drugs Act of 1906 did not go far enough to protect the public health from misbranded, adulterated, and even toxic products, such as an eyelash dye that blinded some women. The Federal Food, Drug, and Cosmetic Act of 1938 further increased government oversight of food and drugs and, for the first time, passed legislation for the regulation of cosmetics and certain medical devices.
For color additives, the 1938 FD&C Act mandated the listing of those coal-tar colors (other than coal-tar hair dyes) that were "harmless and suitable" for use in foods, drugs, and cosmetics. In addition, the Act contained adulteration and misbranding provisions for the use of coal-tar colors in foods, drugs, and cosmetics; required the listing of new colors; and made mandatory the previously voluntary certification program for batches of listed colors, with associated fees. Color additive lakes were in use by this time and were included in the provisions of the 1938 FD&C Act. The initial listing of lakes for food use under the act restricted their use to coloring shell eggs (egg dyeing).
In response to the 1938 Act, and through public hearings, the FDA created the FD&C (Food, Drugs & Cosmetics), D&C (Drugs & Cosmetics), and Ext. D&C (External Drugs & Cosmetics) nomenclature for certifiable color additives. The FDA also established labeling and recordkeeping provisions, identified diluents (substances used to dilute something) that could be added to color additives, and established procedures for requesting certification of color additives and adding new color additives to the permitted list.
In the fall of 1950, many children became ill from eating an orange Halloween candy containing 1-2% FD&C Orange No. 1, a color additive listed for use in food. That same year, U.S. House Representative James Delaney began holding hearings on the possible carcinogenicity of pesticide residues and food additives. These events prompted the FDA to reevaluate all the listed color additives. In the next few years, the FDA found that several color additives caused serious adverse effects and proceeded to terminate their listings. During that time, it also became clear that coal was no longer the primary raw material source for the manufacture of color additives.
The Color Additive Amendments of 1960 defined "color additive" and required that only color additives (except coal-tar hair dyes) listed as "suitable and safe" for a given use could be used in foods, drugs, cosmetics, and certain medical devices. The 1960 Amendments prescribed the factors that the FDA must consider in determining whether a proposed use of a color additive is safe, as well as the specific conditions for safe use that must be included in the listing regulation. The FDA updated the procedural regulations for the petition process in response to these amendments. Under these amendments, the approximately 200 color additives that were in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated due to safety concerns or lack of commercial interest. Permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety.
The 1960 Amendments also contained a "Delaney Clause" that prohibited the listing of a color additive shown to be a carcinogen. The clause states that "A color additive shall be deemed unsafe. . . if the additive is found. . . to induce cancer when ingested by man or animal, or . . . after other relevant exposure of man or animal to such additive."
After 1960, the FDA gradually removed color additives from the provisional list either by permanent listing or by termination of listing. Today about half of the "1960" color additives remain listed; only color additive lakes remain provisionally listed.
Post-market Assessment Related to Color Additives
The FDA stays abreast of the latest science available about color additives in a variety of ways. We participate in international scientific and standard setting activities related to food ingredient safety such as the Codex Alimentarius Commission, attend scientific conferences, and engage other public health and research stakeholders. These activities help us stay informed about the safety and exposure of color additives in scientific literature and released by other agencies.
FDA scientists also assess the science about the exposure and safety of a color additive each time we file a color additive petition. Additionally, we may proactively choose to assess a color additive when new information about its safety profile warrants assessment. The FDA has strict data requirements that must be met to establish safe conditions of use during review of a pre-market submission, and as new scientific information becomes available, we may re-evaluate the safety assessments. This includes reviewing published scientific literature and studies from other regulatory and health agencies in the U.S. and in other countries, and updated information when the same substance is the subject of a new submission. In some of our assessments, we identify areas where additional information is needed. We may work with research partners on studies to help fill these data gaps. We are exploring how to obtain better information on the post-market use of food ingredients, including color additives, from industry and other stakeholders.
If after the FDA’s post-market assessment of a color additive we have determined its use continues to meet our safety standard, the regulatory status of the color additive would remain unchanged. If after the FDA’s post-market assessment of a color additive, we have determined its use does not meet our safety standard, the agency can take various actions to protect public health. These actions include revoking authorizations for its use. For uses that are not authorized, we may issue a public warning letter to companies that manufacture or distribute the color additive and/or food containing the color additive, issue a public alert, and take enforcement action to stop distribution of the color additive and foods containing it on the grounds that such foods are or contain an unapproved color additive. Some changes can take time such as revoking a color additive approval because we are required to follow certain regulatory processes, such as providing an opportunity for public comment.
For more information about the regulatory status of color additives for use in foods, drugs, cosmetics, and certain medical devices in the U.S, see the Inventory of Color Additives.