[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: 21CFR73.1]
[Page 339-341]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of
Subpart A Foods
Sec. 73.1 Diluents in color additive mixtures for food use exempt from
certification.
The following substances may be safely used as diluents in color
additive mixtures for food use exempt from certification, subject to the
condition that each straight color in the mixture has been exempted from
certification or, if not so exempted, is from a batch that has
previously been certified and has not changed in composition since
certification. If a specification for a particular diluent is not set
forth in this part 73, the material shall be of a purity consistent with
its intended use.
(a) General use. (1) Substances that are generally recognized as
safe under the conditions set forth in section 201(s) of the act.
(2) Substances meeting the definitions and specifications set forth
under subchapter B of this chapter, and which are used only as
prescribed by such regulations.
(3) The following:
------------------------------------------------------------------------
Definitions and
Substances specifications Restrictions
------------------------------------------------------------------------
Calcium disodium EDTA Contains calcium May be used in
(calcium disodium ethyl- disodium ethyl- aqueous solutions
enediamine- tetraacetate). enediamine- and aqueous
tetraacetate dispersions as a
dihydrate (CAS preservative and
Reg. No. 6766-87- sequestrant in
6) as set forth in color additive
the Food Chemicals mixtures intended
Codex, 3d ed., p. only for ingested
50, 1981. use; the color
additive mixture
(solution or
dispersion) may
contain not more
than 1 percent by
weight of the
diluent (calculated
as anhydrous
calcium disodium
ethyl-enediamine-
tetraacetate).
Castor oil................... As set forth in Not more than 500
U.S.P. XVI. p.p.m. in the
finished food.
Labeling of color
additive mixtures
containing castor
oil shall bear
adequate directions
for use that will
result in a food
meeting this
restriction.
Dioctylsodium sulfosuccinate. As set forth in Not more than 9
sec. 172.810 of p.p.m. in the
this chapter. finished food.
Labeling of color
additive mixtures
containing
dioctylsodium
sulfosuccinate
shall bear adequate
directions for use
that will result in
a food meeting this
restriction.
[[Page 340]]
Disodium EDTA (disodium ethyl- Contains disodium May be used in
enediamine- tetraacetate). ethyl- enediamine- aqueous solutions
tetraacetate and aqueous
dihydrate (CAS dispersions as a
Reg. No. 6381-92- preservative and
6) as set forth in sequestrant in
the Food Chemicals color additive
Codex, 3d ed., p. mixtures intended
104, 1981. only for ingested
use; the color
additive mixture
(solution or
dispersion) may
contain not more
than 1 percent by
weight of the
diluent (calculated
as anhydrous
disodium ethyl-
enediamine-
tetraacetate).
------------------------------------------------------------------------
(b) Special use--(1) Diluents in color additive mixtures for marking
food--(i) Inks for marking food supplements in tablet form, gum, and
confectionery. Items listed in paragraph (a) of this section and the
following:
------------------------------------------------------------------------
Definitions and
Substances specifications Restrictions
------------------------------------------------------------------------
Alcohol, SDA-3A.............. As set forth in 26 No residue.
CFR pt. 212.
n-Butyl alcohol.............. ................... Do.
Cetyl alcohol................ As set forth in Do.
N.F. XI.
Cyclohexane.................. ................... Do.
Ethyl cellulose.............. As set forth in
sec. 172.868 of
this chapter.
Ethylene glycol monoethyl ................... Do.
ether.
Isobutyl alcohol............. ................... Do.
Isopropyl alcohol............ ................... Do.
Polyoxyethylene sorbitan As set forth in
monooleate (polysorbate 80). sec. 172.840 of
this chapter.
Polyvinyl acetate............ Molecular weight,
minimum 2,000.
Polyvinylpyrrolidone......... As set forth in
sec. 173.55 of
this chapter.
Rosin and rosin derivatives.. As set forth in
sec. 172.615 of
this chapter.
Shellac, purified............ Food grade.........
------------------------------------------------------------------------
(ii) Inks for marking fruit and vegetables. Items listed in
paragraph (a) of this section and the following:
------------------------------------------------------------------------
Definitions and
Substances specifications Restrictions
------------------------------------------------------------------------
Acetone...................... As set forth in No residue.
N.F. XI.
Alcohol, SDA-3A.............. As set forth in 26 Do.
CFR pt. 212.
Benzoin...................... As set forth in
U.S.P. XVI.
Copal, Manila................ ...................
Ethyl acetate................ As set forth in Do.
N.F. XI.
Ethyl cellulose.............. As set forth in
sec. 172.868 of
this chapter.
Methylene chloride........... ................... Do.
Polyvinylpyrrolidone......... As set forth in
sec. 173.55 of
this chapter.
Rosin and rosin derivatives.. As set forth in
sec. 172.615 of
this chapter.
Silicon dioxide.............. As set forth in Not more than 2 pct
sec. 172.480 of of the ink solids.
this chapter.
Terpene resins, natural...... As set forth in
sec. 172.615 of
this chapter.
Terpene resins, synthetic.... Polymers of [alpha]-
and [beta]-pinene.
------------------------------------------------------------------------
(2) Diluents in color additive mixtures for coloring shell eggs.
Items listed in paragraph (a) of this section and the following, subject
to the condition that there is no penetration of the color additive
mixture or any of its components through the eggshell into the egg:
Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue
Service.
Damar gum (resin).
Diethylene glycol distearate.
[[Page 341]]
Dioctyl sodium sulfosuccinate.
Ethyl cellulose (as identified in Sec. 172.868 of this chapter).
Ethylene glycol distearate.
Japan wax.
Limed rosin.
Naphtha.
Pentaerythritol ester of fumaric acid-rosin adduct.
Polyethylene glycol 6000 (as identified in Sec. 172.820 of this
chapter).
Polyvinyl alcohol.
Rosin and rosin derivatives (as identified in Sec. 172.615 of this
chapter).
(3) Miscellaneous special uses. Items listed in paragraph (a) of
this section and the following:
------------------------------------------------------------------------
Definitions and
Substances specifications Restrictions
------------------------------------------------------------------------
Polyvinylpyrrolidone......... As set forth in In or as food-tablet
sec. 173.55 of coatings; limit,
this chapter. not more than 0.1
pct in the finished
food; labeling of
color additive
mixtures containing
polyvinylpyrrolidon
e shall bear
adequate directions
for use that will
result in a food
meeting this
restriction.
------------------------------------------------------------------------
[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992;
69 FR 24511, May 4, 2004]
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