What are color additives and why are they used in food?
A color additive is any substance that imparts color to a food, drug, cosmetic, or to the human body. Color additives include both synthetic substances and substances derived from natural sources. Color additives may be used in food to enhance natural colors, add color to colorless and ‘fun’ foods such as cake decorations, and help identify flavors (such as purple for grape flavor or yellow for lemon). Color additives are sometimes called food dyes.
Are color additives safe to eat?
Yes, color additives are safe when they are used in accordance with with FDA regulations. When the FDA approves the use of a color additive in food, 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 should be identified on the food label.
Do all color additives need to be approved by the FDA before they can be used in foods?
Yes. Under the Federal Food, Drug, and Cosmetic Act, all color additives and new uses for listed color additives must be approved by the FDA before they may be used in foods. A full listing of all approved color additives is available in the Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices.
What criteria does the FDA review when evaluating the safety of a color additive?
When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers several factors. These include the short and long-term effects of consumption, composition and properties, manufacturing process, stability, likely amount of consumption/exposure, and the availability of analytical methods for determining its purity and the amount in food.
Synthetic color additives, also known as certified colors, are required to undergo batch certification, a process in which the FDA analyzes a representative sample of each batch of the color additive to ensure it meets the required identity and specifications before it can be used. Prior to certifying a batch, the FDA analyzes the chemical composition.
There are nine certified color additives approved by the FDA for use in food:
- FD&C Blue No. 1
- Confections, beverages, cereals, frozen dairy desserts, popsicles, frostings & icings
- FD&C Blue No. 2
- Baked goods, cereals, snack foods, ice cream, confections, and yogurt
- FD&C Green No. 3
- Cereal, ice cream, sherbet, drink mixers, and baked goods
- Orange B
- Only approved for use in hot dog and sausage casings
- Citrus Red No. 2
- Only approved for use to color orange peels
- FD&C Red No. 3
- Confections, beverages, cereals, ice cream cones, frozen dairy desserts, popsicles, frostings & icings
- FD&C Red No. 40
- Cereal, beverages, gelatins, puddings, dairy products, and confections
- FD&C Yellow No. 5
- Confections, cereals, snack foods, beverages, condiments, baked goods, and yogurt
- FD&C Yellow No. 6
- Cereals, snack foods, baked goods, gelatins, beverages, dessert powders, crackers, and sauces
What is the difference between a certified and an exempt color additive?
”Exempt” colors include pigments from natural sources such as vegetables, minerals, or animals. Examples include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel (yellow to tan), beta-carotene (yellow to orange) and grape skin extract (red, green). Although exempt color additives are not subject to batch certification requirements, they are still color additives and FDA must approve them before they can be used in foods.
Certified color additives are synthetic colorings that are used widely for intense, uniform color, and because they blend easily to create a variety of hues. These additives are classified as certified because they are required to undergo certification every time a new batch is manufactured.
How do I know whether color additives are in my food?
The FDA requires food manufacturers to list all ingredients on the label, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts. The label must list the names of any FDA-certified color additive (e.g., FD&C Blue No. 1 or the abbreviated name, Blue 1). With the exception of carmine/cochineal extract, color additives exempt from certification can be listed collectively as “artificial colors,” “artificial color added,” “color added,” or equally informative terms, without naming each one. Because of potential allergic reactions in some people, carmine/cochineal extract are required to be identified by name on food labels.
Do color additives affect the behavior of children?
The FDA has reviewed and will continue to examine the effects of color additives on children’s behavior. The totality of scientific evidence indicates 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. The FDA will continue to evaluate emerging science to ensure the safety of color additives approved for use. Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents should also discuss any concerns with their family physician.
Should my family avoid color additives?
Color additives are safe when they are used in accordance with FDA regulations. If you choose to limit your intake of color additives or to avoid them altogether, you can identify whether they are in a product by reading the ingredients on the nutrition label.
If a problem were to arise with a color additive, what would the FDA do?
The FDA continually monitors reports of problems that may be related to color additives and takes action when necessary. The FDA can issue a warning letter to the manufacturer, detain products before they are shipped to stores, issue import alerts, or even seize products that are found to be unsafe or to contain color additives that are prohibited, misused, or not properly identified as ingredients. The FDA may also revoke or amend its regulations of current authorized uses as needed.
If you think that you have or your child has experienced an adverse reaction related to a color additive, you may report the reaction to your nearest FDA district office at https://www.fda.gov/Safety/ReportaProblem/default.htm, or report the problems to CFSAN’s Adverse Event Reporting System (CAERS) by phone at 301-436-2405 or email at CAERS@cfsan.fda.gov.