color additive

color additive is any material, not exempted under section 201(t) of the act, that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting a color thereto. Substances capable of imparting a color to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable handling or use of the container may reasonably be expected to result in the transmittal of the color to the contents of the package or any part thereof. Food ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not regarded ascolor additives; but where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is acolor additive.Food ingredients as authorized by a definitions and standard of identity prescribed by regulations pursuant to section 401 of the act arecolor additives,where the ingredients are specifically designated in the definitions and standards of identity as permitted for use for coloring purposes. An ingredient of an animal feed whose intended function is to impart, through the biological processes of the animal, a color to the meat, milk, or eggs of the animal is a color additive and is not exempt from the requirements of the statute. This definition shall apply whether or not such ingredient has nutritive or other functions in addition to the property of imparting color. An ingested drug the intended function of which is to impart color to the human body is acolor additive.For the purposes of this part, the termcolorincludes black, white, and intermediate grays, but substances including migrants from packaging materials which do not contribute any color apparent to the naked eye are notcolor additives.

Source

21 CFR § 70.3


Scoping language

None
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