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172.615 Chewing gum base.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.615]

[Page 67-69]
 
                        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 
CONSUMPTION--Table of Contents
 
        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
------------------------------------------------------------------------
             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).

[[Page 68]]


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.
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.
------------------------------------------------------------------------


[[Page 69]]

    (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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 615


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