[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.615]
[Page 66-68]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
Subpart G Gums, Chewing Gum Bases and Related Substances
Sec. 172.615 Chewing gum base.
The food additive chewing gum base may be safely used in the
manufacture of chewing gum in accordance with the following prescribed
conditions:
[[Page 67]]
(a) The food additive consists of one or more of the following
substances that meet the specifications and limitations prescribed in
this paragraph, used in amounts not to exceed those required to produce
the intended physical or other technical effect.
Masticatory Substances
natural (coagulated or concentrated latices) of vegetable origin
------------------------------------------------------------------------
Family Genus and species
------------------------------------------------------------------------
Sapotaceae:
Chicle....................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Chiquibul.................... Manilkara zapotilla Gilly.
Crown gum.................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Gutta hang kang.............. Palaquium leiocarpum Boerl. and
Palaquium oblongifolium Burck.
Massaranduba balata (and the Manilkara huberi (Ducke) Chevalier.
solvent-free resin extract
of Massaranduba balata).
Massaranduba chocolate....... Manilkara solimoesensis Gilly.
Nispero...................... Manilkara zapotilla Gilly and Manilkara
chicle Gilly.
Rosidinha (rosadinha)........ Micropholis (also known as Sideroxylon)
spp.
Venezuelan chicle............ Manilkara williamsii Standley and
related spp.
Apocynaceae:
Jelutong..................... Dyera costulata Hook, F. and Dyera
lowii Hook, F.
Leche caspi (sorva).......... Couma macrocarpa Barb. Rodr.
Pendare...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Perillo...................... Couma macrocarpa Barb. Rodr. and Couma
utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca................ Brosimum utile (H.B.K.) Pittier and
Poulsenia spp.; also Lacmellea
standleyi (Woodson), Monachino
(Apocynaceae).
Niger gutta.................. Ficus platyphylla Del.
Tunu (tuno).................. Castilla fallax Cook.
Euphorbiaceae:
Chilte....................... Cnidoscolus (also known as Jatropha)
elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet Hevea brasiliensis.
and latex solids).
------------------------------------------------------------------------
Synthetic Specifications
------------------------------------------------------------------------
Butadiene-styrene rubber..... Basic polymer.
Isobutylene-isoprene Do.
copolymer (butyl rubber).
Paraffin....................... Synthesized by Fischer-Tropsch process
from carbon monoxide and hydrogen
which are catalytically converted to a
mixture of paraffin hydrocarbon. Lower
molecular weight fractions are removed
by distillation. The residue is
hydrogenated and further treated by
percolation through activated
charcoal. The product has a congealing
point of 93[deg]-99 [deg]C as
determined by ASTM method D938-71
(Reapproved 1981), ``Standard Test
Method for Congealing Point of
Petroleum Waxes, Including
Petrolatum,'' a maximum oil content of
0.5 percent as determined by ASTM
method D721-56T, ``Tentative Method of
Test for Oil Content of Petroleum
Waxes,'' and an absorptivity of less
than 0.01 at 290 millimicrons in
decahydronaphthalene at 88 [deg]C as
determined by ASTM method D2008-80,
``Standard Test Method for Ultraviolet
Absorbance and Absorptivity of
Petroleum Products,'' which are
incorporated by reference. Copies may
be obtained from the American Society
for Testing Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia,
PA 19428-2959, or may be examined at
the National Archives and Records
Administration (NARA). For information
on the availability of this material
at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--
register/code--of--federal--
regulations/ibr--locations.html.
Petroleum wax................ Complying with Sec. 172.886.
Petroleum wax synthetic...... Complying with Sec. 172.888.
Polyethylene................. Molecular weight 2,000-21,000.
Polyisobutylene.............. Minimum molecular weight 37,000
(Flory).
Polyvinyl acetate............ Molecular weight, minimum 2,000.
------------------------------------------------------------------------
Plasticizing Materials (Softeners)
------------------------------------------------------------------------
Glycerol ester of partially Having an acid number of 3-8, a minimum
dimerized rosin. drop-softening point of 109 [deg]C,
and a color of M or paler.
Glycerol ester of partially Having an acid number of 3.10, a
hydrogenated gum or wood rosin. minimum drop-softening point of 79
[deg]C, and a color of N or paler.
Glycerol ester of polymerized Having an acid number of 3.12, a
rosin. minimum melting-point of 80 [deg]C,
and a color of M or paler.
[[Page 68]]
Glycerol ester of gum rosin.... Having an acid number of 5-9, a minimum
drop-softening point of 88 [deg]C, and
a color of N or paler. The ester is
purified by steam stripping.
Glycerol ester of tall oil Having an acid number of 2.12, a
rosin. softening point (ring and ball) of
80[deg]-88 [deg]C, and a color of N or
paler. The ester is purified by steam
stripping.
Glycerol ester of wood rosin... Having an acid number of 3-9, a drop-
softening point of 88 [deg]C-96
[deg]C, and a color of N or paler. The
ester is purified by steam stripping.
Lanolin........................ .......................................
Methyl ester of rosin, Having an acid number of 4-8, a
partially hydrogenated. refractive index of 1.5170.1.5205 at
20 [deg]C, and a viscosity of 23-66
poises at 25 [deg]C. The ester is
purified by steam stripping.
Pentaerythritol ester of Having an acid number of 7.18, a
partially hydrogenated gum or minimum drop-softening point of 102
wood rosin. [deg]C, and a color of K or paler.
Pentaerythritol ester of gum or Having an acid number of 6.16, a
wood rosin. minimum drop-softening point of 109
[deg]C, and a color of M or paler.
Rice bran wax.................. Complying with Sec. 172.890.
Stearic acid................... Complying with Sec. 172.860.
Sodium and potassium stearates. Complying with Sec. 172.863.
------------------------------------------------------------------------
Terpene Resins
------------------------------------------------------------------------
Synthetic resin................ Consisting of polymers of
[alpha]pinene, [beta]pinene, and/or
dipentene; acid value less than 5,
saponification number less than 5, and
color less than 4 on the Gardner scale
as measured in 50 percent mineral
spirit solution.
Natural resin.................. Consisting of polymers of [alpha]-
pinene; softening point minimum 155
[deg]C, determined by U.S.P. closed-
capillary method, United States
Pharmacopeia XX (1980) (page 961).
------------------------------------------------------------------------
Antioxidants
------------------------------------------------------------------------
Butylated hydroxyanisole....... Not to exceed antioxidant content of
0.1% when used alone or in any
combination.
Butylated hydroxytoluene....... Do.
Propyl gallate................. Do.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
Sodium sulfate................. .......................................
Sodium sulfide................. Reaction-control agent in synthetic
polymer production.
------------------------------------------------------------------------
(b) In addition to the substances listed in paragraph (a) of this
section, chewing gum base may also include substances generally
recognized as safe in food.
(c) To assure safe use of the additive, in addition to the other
information required by the act, the label and labeling of the food
additive shall bear the name of the additive, ``chewing gum base.'' As
used in this paragraph, the term ``chewing gum base'' means the
manufactured or partially manufactured nonnutritive masticatory
substance comprised of one or more of the ingredients named and so
defined in paragraph (a) of this section.
[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980;
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July
23, 2001; 66 FR 53711, Oct. 24, 2001]
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