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 or colorant?
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 is 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 man-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;
* 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, a
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 (Colorants) 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 (Colorants)
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.

SOURCE U. S. Food and Drug Administration FDA/IFIC* Brochure: January 1993
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