[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.35]
 
[Page 435]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 80--COLOR ADDITIVE CERTIFICATION--Table of Contents
 
                   Subpart B--Certification Procedures
 
Sec. 80.35  Color additive mixtures; certification and exemption from certification.
 
    (a) Color additive mixtures to be certified. Any color additive
mixture that contains one or more straight colors listed in part 74 of
this chapter, together with any diluents listed in such subparts for use
with such straight colors, shall be certified if intended for use in
foods, drugs, or cosmetics, or in coloring the human body, as the case
may be, subject to any restriction prescribed in parts 70 and 71 of this
chapter.
    (b) Color additive mixtures exempted from certification. A color
additive mixture prepared from a previously certified batch of one or
more straight colors, with or without any diluent that has been listed
in part 73 of this chapter for use in mixtures, shall be exempt from
batch certification if the straight color used has not changed in
composition in any manner whatsoever since its certification and if it
is simply mixed with the approved diluents for exempt mixtures. The
label of such color additive mixtures shall not bear the lot number
assigned by the Food and Drug Administration to the certified straight
color components, but shall bear the manufacturer's control number
through which the history of the straight color can be determined.
    (c) Additions to the list of diluents. A person requesting additions
to the list of diluents authorized for the purposes described in
paragraphs (a) and (b) of this section shall submit a petition in
accordance with the provisions of Sec. 71.1 of this chapter. Each such
petition shall be accompanied by the fee prescribed in Sec. 70.19 of
this chapter, unless there is an advance deposit to be used for
prepayment of such fees.
 
    Note: The provisions of Sec. 80.35 with respect only to diluents for
use in cosmetic color additive mixtures were stayed, until a regulation
is effected listing safe diluents for cosmetic use, including cosmetics
which color the human body, 29 FR 18495, Dec. 29, 1964.