• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2013]
[CITE: 21CFR172.615]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

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:

(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

FamilyGenus and species
Sapotaceae:
ChicleManilkara zapotilla Gilly and Manilkara chicle Gilly.
ChiquibulManilkara zapotilla Gilly.
Crown gumManilkara zapotilla Gilly and Manilkara chicle Gilly.
Gutta hang kangPalaquium leiocarpum Boerl. and Palaquium oblongifolium Burck.
Massaranduba balata (and the solvent-free resin extract of Massaranduba balata)Manilkara huberi (Ducke) Chevalier.
Massaranduba chocolateManilkara solimoesensis Gilly.
NisperoManilkara zapotilla Gilly and Manilkara chicle Gilly.
Rosidinha (rosadinha)Micropholis (also known as Sideroxylon) spp.
Venezuelan chicleManilkara williamsii Standley and related spp.
Apocynaceae:
JelutongDyera costulata Hook, F. and Dyera lowii Hook, F.
Leche caspi (sorva)Couma macrocarpa Barb. Rodr.
PendareCouma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
PerilloCouma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vacaBrosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi (Woodson), Monachino (Apocynaceae).
Niger guttaFicus platyphylla Del.
Tunu (tuno)Castilla fallax Cook.
Euphorbiaceae:
ChilteCnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet and latex solids)Hevea brasiliensis.
Synthetic Specifications
Butadiene-styrene rubberBasic polymer.
Isobutylene-isoprene copolymer (butyl rubber) Do.
ParaffinSynthesized 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 93deg. -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 waxComplying with 172.886.
Petroleum wax syntheticComplying with 172.888.
PolyethyleneMolecular weight 2,000-21,000.
PolyisobutyleneMinimum molecular weight 37,000 (Flory).
Polyvinyl acetateMolecular weight, minimum 2,000.
Plasticizing Materials (Softeners)
Glycerol ester of partially dimerized rosinHaving an acid number of 3-8, a minimum drop-softening point of 109 deg. C, and a color of M or paler.
Glycerol ester of partially hydrogenated gum or wood rosinHaving an acid number of 3-10, a minimum drop-softening point of 79 deg. C, and a color of N or paler.
Glycerol ester of polymerized rosinHaving an acid number of 3-12, a minimum melting-point of 80 deg. C, and a color of M or paler.
Glycerol ester of gum rosinHaving 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 rosinHaving an acid number of 2-12, a softening point (ring and ball) of 80deg. -88 deg. C, and a color of N or paler. The ester is purified by steam stripping.
Glycerol ester of wood rosinHaving 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, partially hydrogenatedHaving an acid number of 4-8, a 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 partially hydrogenated gum or wood rosinHaving an acid number of 7-18, a minimum drop-softening point of 102 deg. C, and a color of K or paler.
Pentaerythritol ester of gum or wood rosinHaving an acid number of 6-16, a minimum drop-softening point of 109 deg. C, and a color of M or paler.
Rice bran waxComplying with 172.890.
Stearic acidComplying with 172.860.
Sodium and potassium stearatesComplying with 172.863.
Terpene Resins
Synthetic resinConsisting 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 resinConsisting 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 hydroxyanisoleNot to exceed antioxidant content of 0.1% when used alone or in any combination.
Butylated hydroxytoluene Do.
Propyl gallate Do.
Miscellaneous
Sodium sulfate
Sodium sulfideReaction-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]

-
-