[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: 21CFR70.25]
[Page 328-329]
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 B Packaging and Labeling
Sec. 70.25 Labeling requirements for color additives (other than hair dyes).
(a) General labeling requirements. All color additives shall be
labeled with sufficient information to assure their safe use and to
allow a determination of compliance with any limitations imposed by this
part and parts 71, 73, 74, 80, and 81 of this chapter. In addition to
[[Page 329]]
all other information required by the act, labels for color additives,
except those in a form suitable for coloring the human body, shall
state:
(1) The name of the straight color or the name of each ingredient
comprising the color additive, if it is a mixture.
(2) A statement indicating general limitations for the use of the
color additive, such as ``for food use only''; ``for food, drug, and
cosmetic use''; ``for use in drugs for external application only.''
(3) Where regulations issued impose quantitative limitations for a
general or specific use of a straight color, the amount of each such
straight color in terms of weight per unit/volume or percent by weight.
(4) An expiration date if stability data require it.
(b) Special labeling for color additives with tolerances. Where
tolerances are imposed for a general or specific use of a color
additive, the label shall in addition provide directions for use of the
color additive which if followed will preclude the food, drug, or
cosmetic to which it is added from containing an amount of the color
additive in excess of the tolerance.
(c) Special labeling for color additives with other limitations. If
use of the color additive is subject to other limitations prescribed in
this part, such limitations shall be stated on the label of the color
additive by a plain and conspicuous statement. Examples of such
limitation statements are: ``Do not use in products used in the area of
the eye''; ``Do not use for coloring drugs for injection.''
(d) Special labeling for color additives not exempt from
certification. Color additives not exempt from the certification
procedures shall in addition include in the labeling the lot number
assigned by the Color Certification Branch, except that in the case of
any mixture for household use which contains not more than 15 percent of
pure color and which is in packages containing not more than 3 ounces
there appears on the label, a code number which the manufacturer has
identified with the lot number by giving to the Food and Drug
Administration written notice that such code number will be used in lieu
of the lot number.
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