[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.3]
[Page 324-326]
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 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
[[Page 325]]
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 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
[[Page 326]]
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]
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