How safe are color additives?

U.S. Food and Drug Administration (FDA)

Color additives give the red tint to your fruit punch or makeup, and the green hue to your mint-flavored toothpaste or body lotion. They are dyes, pigments, or other substances that impart color when added or applied to a food, drug, cosmetic, or the human body. They can be found in a range of consumer products — such as cough syrup, eyeliner, contact lenses and cereal, to name a few.

So how safe are they? “Color additives are safe when used properly,” says Linda Katz, M.D., M.P.H., director of the U.S. Food and Drug Administration’s Office of Cosmetics and Colors. “There is no such thing as absolute safety of any substance. In the case of a new color additive, the FDA determines if there is ‘a reasonable certainty of no harm’ under the color additive’s proposed conditions of use.”

Color additive safety

The FDA regulates color additives used in the U.S. This includes those used in foods (including dietary supplements), drugs, cosmetics, and certain medical devices. Most color additives must be approved by the agency before they can be used in these products and must be used only in compliance with the approved uses, specifications, and restrictions. There are some exceptions. One example is synthetic organic dyes, traditionally called “coal-tar dyes,” for use in hair dye products. These color additives do not need to be approved by the FDA before being used in products entering the market as long as the products’ labels include both a statutory caution statement and instructions for patch-testing. In the approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. The FDA does not approve color additives that the agency has found to cause cancer in animals or humans.

Two main categories make up the FDA’s list of permitted color additives. In addition to undergoing approval, some color additives are known as “certifiable.” Certifiable color additives are human-made and come primarily from petroleum and coal sources. In the certification procedure, a manufacturer submits a sample from the batch for which the manufacturer is requesting certification, and the FDA tests the sample to determine whether the sample meets the color additive’s requirements for composition and purity. If it does, the FDA “certifies” the batch and issues a certification lot number. Only then can that batch be used legally in FDA-regulated products.

Certified color additives have special names consisting of a prefix, such as FD&C (Food, Drugs & Cosmetics), D&C (Drugs & Cosmetics), or Ext. D&C (External Drugs & Cosmetics); a color; and a number. An example is FD&C Yellow No. 6, which is often found in cereals, ice cream, and baked goods. Each certified color additive is required to be declared on product labels by its listed name or by a shortened form of its name, consisting of just the color and number, such as Yellow 6.

Other color additives, in the second main category, are “exempt” from batch certification. These are obtained largely from plant, animal, or mineral sources. Examples include annatto extract and grape color extract. They are not subject to batch certification requirements, but they are still artificial color additives and must comply with regulatory requirements. Both types of color additives are subject to the same rigorous safety standard.

Approval of a color additive for one intended use does not mean approval for other uses. For example, no color additives have been approved for injection into the skin — even though tattoo parlors often claim that the pigments in their inks are “FDA-approved.” Likewise, no color additives are approved for permanent makeup (a form of tattooing). And henna is approved for use on the hair, but not the skin.

Reactions to color additives are rare. It is possible, but rare, to have an allergic-type reaction to a color additive. For example, FD&C Yellow No. 5 may cause itching and hives in some people. This color additive is widely found in foods (for example, beverages, desserts, candy, and breakfast cereals), drugs, and cosmetics. The FDA requires all color additives to be declared by their listed names or appropriate abbreviations on product labels so that they can be identified by consumers. On medicine labels, the certified color additive FD&C Yellow No. 5 must also be identified by its uncertified name, “tartrazine.”

The FDA has reviewed and will continue to examine the effects of color additives on children’s behavior. The totality of scientific evidence shows that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them. In 2011, the FDA convened its Food Advisory Committee (FAC) External Link Disclaimer to consider whether available relevant data demonstrate a link between children’s consumption of certified color additives in foods and adverse effects on their behavior. The FAC concluded that a link between children’s consumption of certified color additives causing behavioral effects had not been established. Further neurobehavioral research is needed to explain potential pathways underlying these sensitivities. The FDA will continue to assess the emerging science and ensure the safety of approved color additives. Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents may also discuss any concerns with their family physician.

The FDA can take action against companies if there are violations. In the absence of a voluntary action such as a product recall, the FDA can issue warning letters, detentions, and import alerts for products that are found to be unsafe or contain color additives that are unauthorized, misused, or not properly identified as ingredients. The FDA can also seize such products. Color additive violations are a common reason for detaining imported cosmetic products that are offered for entry into the U.S.

The FDA monitors reports of problems related to color additives. If you think you or your child has experienced an adverse reaction to a color additive, you can report the reaction to your local FDA Consumer Complaint Coordinator. The phone number for the FDA Consumer Complaint Coordinator in Florida is (866) 337-6272 (toll free). Find the phone number for other states at this link: www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinatorshttp://www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinators.

You can also report problems to the Center for Food Safety and Applied Nutrition's (CFSAN’s) Adverse Event Reporting System (CAERS) by phone at (301) 436-2405 or by email at CAERS@cfsan.fda.gov.