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FDA/IFIC*  Brochure: January 1993
 
 
                          Food Color Facts
 
The color of food is an integral part of our culture and enjoyment
of life. Who would deny the mouth-watering appeal of a deep-pink
strawberry ice on a hot summer day or a golden Thanksgiving turkey
garnished with fresh green parsley?
 
Even early civilizations such as the Romans recognized that people
"eat with their eyes" as well as their palates. Saffron and other
spices were often used to provide a rich yellow color to various
foods. Butter has been colored yellow as far back as the 1300's.
 
Today all food color additives are carefully regulated by federal
authorities to ensure that foods are safe to eat and accurately
labeled. This brochure provides helpful background information
about color additives, why they are used in foods, and regulations
governing their safe use in the food supply.
 
 
What is a Color Additive?
 
Technically, a color additive is any dye, pigment or substance that
can impart color when added or applied to a food, drug, cosmetic or
to the human body.
 
The Food and Drug Administration (FDA) is responsible for
regulating all color additives used in the United States. All color
additives permitted for use in foods are classified as
"certifiable" or "exempt from certification" (see Table I).
 
Certifiable color additives are manmade, with each batch being
tested by manufacturer and FDA. This "approval" process, known as
color additive certification, assures the safety, quality,
consistency and strength of the color additive prior to its use in
foods.
 
There are nine certified colors approved for use in food in the
United States. One example id FD&C Yellow No.6, which is used in
cereals, bakery goods, snack foods and other foods.
 
Color additives that are exempt from certification include pigments
derived from natural sources such as vegetables, minerals or
animals, and man-made counterparts of natural derivatives.
 
For example, caramel color is produced commercially by heating
sugar and other carbohydrates under strictly controlled conditions
for use in sauces, gravies, soft drinks, baked goods and other
foods.
 
Whether a color additive is certifiable or exempt from
certification has no bearing on its overall safety. Both types of
color additives are subject to rigorous standards of safety prior
to their approval for use in foods.
 
Certifiable color additives are used widely because their coloring
ability is more intense than most colors derived from natural
products; thus, they are often added to foods in smaller
quantities. In addition, certifiable color additives are more
stable, provide better color uniformity and blend together easily
to provide a wide range of hues. Certifiable color additives
generally do not impart undesirable flavors to foods, while color
derived from foods such as beets and cranberries can produce such
unintended effects.
 
Of nine certifiable colors approved for use in the United States,
seven color additives are used in food manufacturing (see Table
II). Regulations known as Good Manufacturing Practices limit the
amount of color added to foods. Too much color would make foods
unattractive to consumers, in addition to increasing costs.
 
 
What Are Dyes and Lakes?
 
Certifiable color additives are available for use in food as either
"dyes" or "lakes." Dyes dissolve in water and are manufactured as
powders, granules, liquids or other special purpose forms. They can
be used in beverages, dry mixes, baked goods, confections, dairy
products, pet foods and a variety of other products.
 
Lakes are the water insoluble form of the dye. Lakes are more
stable than dyes and are ideal for coloring products containing
fats and oils or items lacking sufficient moisture to dissolve
dyes. Typical uses include coated tablets, cake and donut mixes,
hard candies and chewing gums.
 
 
Why Are Color Additives Used In Foods?
 
Color is an important property of foods that adds to our enjoyment
of eating. Nature teaches is early to expect certain colors in
certain foods, and our future acceptance of foods is highly
dependent on meeting these expectations.
 
Color variation in foods throughout the seasons and the effects of
food processing and storage often require that manufacturers add
color to certain foods to meet consumer expectations. The primary
reasons of adding colors to foods include:
 
-  To offset color loss due to exposure to light, air, extremes of
temperature, moisture and storage conditions.
 
-  To correct natural variations in color. Off-colored foods are
often incorrectly associated with inferior quality. For example,
some tree-ripened oranges are often sprayed with Citrus Red No.2 to
correct the natural orangy-brown or mottled green color of their
peels (Masking inferior quality, however, is an unacceptable use of
colors.)
 
-  To enhance colors that occur naturally but at levels weaker than
those usually associated with a given food.
 
-  To provide a colorful identity to foods that would otherwise be
virtually colorless. Red colors provide a pleasant identity to
strawberry ice while lime sherbet is known by its bright green
color.
 
-  To provide a colorful appearance to certain "fun foods." Many
candies and holiday treats are colored to create a festive
appearance.
 
-  To protect flavors and vitamins that may be affected by sunlight
during storage.
 
-  To provide an appealing variety of wholesome and nutritious
foods that meet consumers' demands.
 
 
How Are Color Additives Regulated?
 
In 1900, there were about 80 manu-made color additives available
for use in foods. At that time there were no regulations regarding
the purity and uses of these dyes.
 
Legislation enacted since the turn of the century, however, has
greatly improved food color additive safety and stimulated
improvements in food color technology.
 
The Food and Drug Act of 1906 permitted or "listed" seven man-made
color additives for use in foods. The Act also established a
voluntary certification program, which was administered by the U.S.
Department of Agriculture (USDA); hence man-made color additives
became known as "certifiable color additives.
 
The Federal Food, Drug & Cosmetic (FD&C) Act of 1938 made food
color additive certification mandatory and transferred the
authority for its testing from USDA to FDA. To avoid confusing
color additives used in food with those manufactured for other
uses, three categories of certifiable color additives were created.
 
Food, Drug and Cosmetic (FD&C)-
Color additives with application in foods, drugs or cosmetics;
Drug and Cosmetic (D&C)-
Color additives with applications in drugs or cosmetics; and
External Drug and Cosmetic (External D&C)-
Color additives with applications in externally applied drugs (e.g.
ointments) and in externally applied cosmetics.
 
In 1960, the Color Additive Amendments to the FD&C Act placed color
additives on a "provisional" list and required further testing
using up-to -date procedures. One section of the amendment known as
the Delaney Clause, prohibits adding to any food substance that has
been shown to cause cancer in animals or man regardless of the
dose. Under the amendments, color additives exempt from
certification also are required to meet rigorous safety standards
prior to being permitted for use in foods.
 
According to the Nutrition Labeling and Education Act of 1990, an
certifiable color additive used in food must be listed in the
ingredient statement by its common or usual name. All label printed
after July 1, 1991 must comply with this requirement.
 
 
How Are Color Additives Approved for Use in Foods?
 
To market a new color additive, a manufacturer must first petition
FDA for its approval.
 
The petition must provide convincing evidence that the proposed
color additive performs as it is intended. Animal studies using
large doses of the color additive for long periods are often
necessary to show that the substance would not cause harmful
effects at expected levels of human consumption. Studies of the
color additive in humans also may be submitted to FDA.
 
In deciding whether a color additive should be approved, the agency
considers the composition and properties of the substance, the
amount likely to be consumed, its probable long-term effects and
various safety factors. Absolute safety of any substance can never
be proven. Therefore, FDA must determine if there is a reasonable
certainty of no harm from the color additive under its proposed
conditions of use.
 
If the color additive is approved, FDA issues regulations that may
include the types of foods in which it can be used, the maximum
amounts to be used and how it should be identified on food labels.
Color additives proposed for use in meat and poultry products also
must receive specific authorization by USDA.
 
Federal officials then carefully monitor the extent of Americans'
consumption of the new color additive and results of any new
research on its safety.
 
In addition, FDA operates an Adverse Reaction Monitoring System
(ARMS) to help serve as an ongoing safety check of all activities.
The system monitors and investigates all complaints by individuals
or their physicians that are believed to be related to food and
color additives; specific foods; or vitamin and mineral
supplements. The ARMS computerized database helps officials decide
whether reported adverse reactions represent a real public health
hazard, so that appropriate action can be taken.
 
 
Additional Information About Color Additives
 
Q.  Are certain people sensitive to FD&C Yellow No.5 in foods?
 
A.  FDA's Advisory Committee on Hypersensitivity to Food
Constituents concluded in 1986 that FD&C Yellow No.5 may cause
hives in fewer that one out of 10,000 people. The committee found
that there was no evidence the color additive in foods provokes
asthma attacks nor that aspirin-intolerant individuals may have a
cross-sensitivity to the color. As with other color additives
certifiable for food use, whenever FD&C Yellow No.5 is added to
foods, it is listed on the product label. This allows the small
portion of people who may be sensitive to the color to avoid it.
 
Q.  What is the status of FD&C Red No.3?
 
A.  In 1990, FDA discontinued the provisional listing of all lake
forms of FD&C Red No.3 and its dye form used in external drugs and
cosmetics. The uses were terminated because one study of the color
additive in male rats showed an association with thyroid tumors. In
announcing the decision, FDA that any human risk posed by FD&C Red
No.3 was extremely small and was based less on safety concerns than
the legal mandate of the Delaney Clause. FD&C Red No.3 remains
permanently listed for use in food and ingested drugs, although FDA
has announced its intent to propose rescinding those listings.
 
Q.  Why are decisions sometimes changed about the safety of food
color additives?
 
A.  Since absolute safety of any substance can never be proven,
decisions about the safety of color additives or other food
ingredients are made on the best scientific evidence available.
Because scientific knowledge is constantly evolving, federal
officials often review earlier decisions to assure that the safety
assessment of a food substance remains up-to-date. Any change made
in previous clearances should be recognized as an assurance that
the latest and best scientific knowledge is being applied to
enhance the safety of the food supply.
 
Q.  Do food color additives cause hyperactivity?
 
A.  Although this theory was popularized in the 1970's,
well-controlled studies conducted since then have produced no
evidence that food color additives cause hyperactivity or learning
disabilities in children. A Consensus Development Panel of the
National Institutes of Health concluded in 1982 that there was no
scientific evidence to support the claim that colorings or other
food additives cause hyperactivity.  The  panel said that
elimination diets should not be used universally to treat childhood
hyperactivity, since there is no scientific evidence to predict
which children may benefit.
 
 

Table 1. Color Additives Permitted For Direct Addition To Human
Food In The United States
 
Certifiable Colors
 
FD&C Blue No.1 (Dye and Lake)
FD&C Blue No.2 (Dye and Lake)
FD&C Green No.3 (Dye and Lake)
FD&C Red No.3 (Dye)
FD&C Red No.40 (Dye and Lake)
FD&C Yellow No.5 (Dye and Lake)
FD&C Yellow No.6 (Dye and Lake)
Orange B*
Citrus Red No.2*
 
 
Colors Exempt from Certification
 
Annatto extract
B-Apo-8'-carotenal*
Beta-carotene
Beet powder
Canthaxanthin
Caramel color
Carrot oil
Cochineal extract (carmine)
Cottonseed flour, toasted partially defatted, cooked
Ferrous gluconate*
Fruit juice
Grape color extract*
Grape skin extract* (enocianina)
Paprika
Paprika oleoresin
Riboflavin
Saffron
Titanium dioxide*
Turmeric
Turmeric oleoresin
Vegetable juice
 
*These food color additives are restricted to specific uses.
 
 
 
Table II. Color Additives Certifiable For Food Use
 
Name/Common Name       Hue              Common Food Uses
 
FD&C Blue No.1         Bright blue      Beverages, dairy products
  Brilliant Blue FCF                    powders, jellies, confec-
                                        tions, condiments, icings
                                        syrups, extracts
 
FD&C Blue No.2         Royal Blue       Baked goods, cereals, snack
  Indigotine                            foods, ice cream, confec-
                                        tions, cherries
 
FD&C Green No.3        Sea Green        Beverages, puddings, ice
  Fast Green FCF                        cream, sherbert, cherries,
                                        confections, baked goods,
                                        dairy products
 
FD&C Red No.40         Orange-red       Gelatins, puddings, dairy
  Allura Red AC                         products, confections,
                                        beverages, condiments
 
FD&C Red No.3          Cherry-red       Cherries in fruit cocktail
  Erythrosine                           and in canned fruits for
                                        salads, confections, baked
                                        goods, dairy products,
                                        snack foods
 
FD&C Yellow No.5       Lemon Yellow     Custards, beverages, ice
Tartrazine                              cream, confections,
                                        preserves, cereals
 
FD&C Yellow No.6       Orange           Cereals, baked goods, snack
  Sunset Yellow                         foods, ice cream,
                                        beverages, dessert powders,
                                        confections
 
 
Food and Drug Administration HFI 140
5600 Fishers Lane Rockville MD 20857
 
in cooperation with
 
International Food Information Council Foundation
1100 Connecticut Ave, N.W. Suite 430
Washington, D.C. 20036
 
January 1993