[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: 21CFR82.6]

[Page 444]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 82--LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 82.6  Certifiable mixtures.

    (a) A batch of a mixture which contains no straight color listed in 
subpart C or D may be certified for use in food, drugs and cosmetics, 
if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture;
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein; and
    (3) No diluent (except resins, natural gum, pectin and, in the case 
of mixtures which are aqueous solutions or aqueous pastes, sodium 
benzoate in a quantity of not more than \1/10\ of 1 percent) in such 
mixture is a nonnutritive substance, unless such mixture is for external 
application to shell eggs, or for use in coloring a food specified in 
the requests for certification of such batch submitted in accordance 
with Sec. 80.21 of this chapter, and such diluent, in the usual process 
of manufacturing such food, is removed and does not become a component 
of such food.
    (b) A batch of a mixture which contains no straight color listed in 
subpart D, or which contains a diluent not permitted by paragraph (a)(3) 
of this section, may be certified in accordance with the provisions of 
this part, for use only in drugs and cosmetics, if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture.
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein.
    (c) A batch of a mixture which contains a straight color listed in 
subpart D may be certified in accordance with the provisions of this 
part, for use only in externally applied drugs and cosmetics, if:
    (1) Each coal-tar color used as an ingredient in mixing such batch 
is from a previously certified batch and such color has not changed in 
composition in any manner whatever since such previous certification, 
except by mixing into such batch of mixture; and
    (2) Each diluent in such batch of mixture is harmless and suitable 
for use therein.