Color Additives in Foods

Colored substances are added to foods to modify the appearnce of insufficiently colored or discolored foods and to create new foods. The following criteria must be met if a food color (colorant) is to be used;

1. it must be safe at the level and under the conditions of use;
2. it must be stable in the products in which is added;
3. it must not impart any offensive property (flavor, texture) to the product;
4. it must be easy to apply;
5. it must have a high tinctorial power; and
6. it must not be too costly.

There are two classes of color additives, those that must be certified and those that are exempt from certification. Both are strictly controlled in the United States by regulatory statutes (Food Color Additives Amendments), but an official certificate is required for each commercial batch of color of the first group, while no such certificate is necessary for the second group. For certification the manufacturer must submit a sample of the batch to the Food & Drug Administration for chemical analysis. The results of the analysis are compared with the specifications for certified colors published in the Code of Federal Regulations. If the compliance is complete, a certificate is issued for that particular batch of color.

When a new color is to be introduced, the petitioner is expected to provide data proving that the new additive is safe and effective. The safety tests are elaborate and expensive. They include chronic toxicity feeding tests with two animal species over several generations. The effectiveness tests include long-term color stability experiments in the foods to which the color is to be added.

TABLE IV Permanently Listed Food Colors Subject to Certification

Color	Structure	Usesa
FD&C Blue #1		Used in amounts consistent with GMP
FD&C Green #3		Used in amounts consistent with GMP
FD&C Yellow #5		Used in amounts consistent with GMP
FD&C Red #3b		Used in amounts consistent with GMP
FD&C Red #40		Used in amounts consistent with GMP
Orange B		Coloring sausage surfaces or casings (150 ppm max. based on finished product)
FD&C Blue #2		Used in amounts consistent with GMP
FD&C Yellow #6		Used in amounts consistent with GMP
Citrus Red #2		In skins of oranges that are not intended for processing (at 2 ppm max., based on whole fruit)
a GMP. Good manufacturing practices. b The FDA has recently banned the use of Red #3 in such products as cake frostings, certain processed foods, cough drops, and lipstick, in which the color is mixed with other additives reacting with it. This dye can still be applied directly to meat, nut products, fruit and fruit juices, candy, confections, and breakfast cereals.

The food color additives subject to certification are listed in Table IV. The initials FD&C stand for the Food, Drug & Cosmetic Act under which these additives are regulated. The food color additives exempt from certification are listed in Table V. Generally, only synthetic organic colorants are subject to certification, while natural organic and inorganic colors, such as paprika and titanium oxide are not. The colorant β-carotene is not subject to certification whether it is obtained from a natural source or it is synthetically produced.

TABLE V Permanently Listed Colors Exempt from Certification

Colorant	Usesa	Colorant	Usesa
Caramel	In foods, generally consistent with GMP	Cochineal extract; carmine	In foods, generally consistent with GMP
β-Carotene	In foods, generally consistent with GMP	Dehydrated beets	In foods, generally consistent with GMP
Annatto extract	In foods, generally consistent with GMP	Riboflavin	In foods, generally consistent with GMP
Paprika	In foods, generally consistent with GMP	Carrot oil	In foods, generally consistent with GMP
Paprika oleoresin	In foods, generally consistent with GMP	β-Apo-8´-carotenal	In foods, generally not to exceed 25 mg/lb
Turmeric	In foods, generally consistent with GMP	Titanium dioxide	In foods, generally not to exceed 1% by weight
Turmeric oleoresin	In foods, generally consistent with GMP	Grape skin extract	In still and carbonated beverages and alcoholic beverages
Saffron	In foods, generally consistent with GMP	Ferrous gluconate	For coloring ripe olives, consistent with GMP
Fruit juice	In foods, generally consistent with GMP	Canthaxanthin	In foods, generally not to exceed 30 mg/lb
Vegetable juice	In foods, generally consistent with GMP
Toasted, partially defatted, cooked cottonseed flour	In foods, generally consistent with GMP
a GMP, Good manufacturing practices.

While synthetic food dyes are generally water-soluble, food lakes are water-insoluble. Food lakes are prepared by precipitating dyes on alumina. These lakes are useful for coloring water-repelling foods, such as fats and oils, certain gums, as well as packaging materials, e.g., plastic films, lacquers and inks, from which soluble dyes would leach out. Listing of a food dye does not necessarily imply listing the corresponding lake.

Polymeric food dyes have been developed that cannot pass the gastrointestinal wall and are excreted virtually intact in the feces. Toxicity and efficacy tests must be completed before FDA approval is granted to these dyes.

In recent years, plant tissue culture techniques have been applied to the production of food colors. Also the pigments of two fungi: Monascus anka and Monascus purpureus are being considered for use in foods. These fungal pigments have been used as food colors and medicines in the Far East for hundreds of years.

The regulations regarding color additives can be found in the Code of Federal Regulations, Title 21, Parts 70–82. Changes in these regulations are published in the “Federal Register.” Additional information on color additives can be obtained from:

Food & Drug Administration,
Division of Color & Cosmetics,
200 C Street. S. W. Washington, DC 20204.