[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: 21CFR82.6]
[Page 441]
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--
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.
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