[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.35]

[Page 429]
 
                        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.