[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.3]

[Page 328-330]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 70--COLOR ADDITIVES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 70.3  Definitions.


    (a) Secretary means the Secretary of Health and Human Services.
    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) Act means the Federal Food, Drug, and Cosmetic Act as amended.
    (e) Color Certification Branch means the unit established within the 
Food and Drug Administration located in the Center for Food Safety and 
Applied Nutrition, charged with the responsibility for the mechanics of 
the certification procedure hereinafter described, and including the 
examination of samples of color additives subject to certification.
    (f) A 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

[[Page 329]]

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 as color additives; 
but where a food substance such as beet juice is deliberately used as a 
color, as in pink lemonade, it is a color additive. Food ingredients as 
authorized by a definitions and standard of identity prescribed by 
regulations pursuant to section 401 of the act are color 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 a color additive. For the 
purposes of this part, the term color includes black, white, and 
intermediate grays, but substances including migrants from packaging 
materials which do not contribute any color apparent to the naked eye 
are not color additives.
    (g) For a material otherwise meeting the definition of color 
additive to be exempt from section 721 of the act, on the basis that it 
is used (or intended to be used) solely for a purpose or purposes other 
than coloring, the material must be used in a way that any color 
imparted is clearly unimportant insofar as the appearance, value, 
marketability, or consumer acceptability is concerned. (It is not enough 
to warrant exemption if conditions are such that the primary purpose of 
the material is other than to impart color.)
    (h) The exemption that applies to a pesticide chemical, soil or 
plant nutrient, or other agricultural chemical, where its coloring 
effect results solely from its aiding, retarding, or otherwise affecting 
directly or indirectly, the growth or other natural physiological 
processes of produce of the soil, applies only to color developed in 
such product through natural physiological processes such as enzymatic 
action. If the pesticide chemical, soil or plant nutrient, or other 
agricultural chemical itself acts as a color or carries as an ingredient 
a color, and because of this property colors the produce of the soil, it 
is a color additive and is not exempt.
    (i) Safe means that there is convincing evidence that establishes 
with reasonable certainty that no harm will result from the intended use 
of the color additive.
    (j) The term straight color means a color additive listed in parts 
73, 74, and 81 of this chapter, and includes lakes and such substances 
as are permitted by the specifications for such color.
    (k) The term mixture means a color additive made by mixing two or 
more straight colors, or one or more straight colors and one or more 
diluents.
    (l) The term lake means a straight color extended on a substratum by 
adsorption, coprecipitation, or chemical combination that does not 
include any combination of ingredients made by simple mixing process.
    (m) The term diluent means any component of a color additive mixture 
that is not of itself a color additive and has been intentionally mixed 
therein to facilitate the use of the mixture in coloring foods, drugs, 
or cosmetics or in coloring the human body. The diluent may serve 
another functional purpose in the foods, drugs, or cosmetics, as for 
example sweetening, flavoring, emulsifying, or stabilizing, or may be a 
functional component of an article intended for coloring the human body.
    (n) The term substratum means the substance on which the pure color 
in a lake is extended.
    (o) The term pure color means the color contained in a color 
additive, exclusive of any intermediate or other component, or of any 
diluent or substratum contained therein.
    (p) The term batch means a homogeneous lot of color additive or 
color additive mixture produced by an identified production operation, 
which is

[[Page 330]]

set apart and held as a unit for the purpose of obtaining certification 
of such quantity.
    (q) The term batch number means the number assigned to a batch by 
the person who requests certification thereof.
    (r) The term lot number means an identifying number or symbol 
assigned to a batch by the Food and Drug Administration.
    (s) The term area of the eye means the area enclosed with in the 
circumference of the supra-orbital ridge and the infra-orbital ridge, 
including the eyebrow, the skin below the eyebrow, the eyelids and the 
eyelashes, and conjunctival sac of the eye, the eyeball, and the soft 
areolar tissue that lies within the perimeter of the infra-orbital 
ridge.
    (t) The term package means the immediate container in which a color 
additive or color additive mixture has been packed for shipment or 
delivery. If the package is then packed in a shipping carton or other 
protective container, such container shall not be considered to be the 
immediate container. In the case of color additive mixtures for 
household use containing less than 15 percent pure color, when two or 
more containers of 3 ounces each or less, each containing a different 
color, are distributed as a unit, the immediate container for such unit 
shall be considered to be the package as defined in this section.
    (u) The hair dye exemption in section 601(a) of the act applies to 
coal tar hair dyes intended for use in altering the color of the hair 
and which are, or which bear or contain, color additives derived from 
coal tar with the sensitization potential of causing skin irritation in 
certain individuals and possible blindness when used for dyeing the 
eyelashes or eyebrows. The exemption is permitted with the condition 
that the label of any such article bear conspicuously the statutory 
caution and adequate directions for preliminary patch-testing. The 
exemption does not apply to coloring ingredients in hair dyes not 
derived from coal tar, and it does not extend to poisonous or 
deleterious diluents that may be introduced as wetting agents, hair 
conditions, emulsifiers, or other components in a color shampoo, rinse, 
tint, or similar dual-purpose cosmetic that alter the color of the hair.
    (v) The terms externally applied drugs and externally applied 
cosmetics mean drugs or cosmetics applied only to external parts of the 
body and not to the lips or any body surface covered by mucous membrane.

[42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996]