21 C.F.R. § 172.615 Chewing gum base.
Title 21 - Food and Drugs
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. (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]
Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart G—Gums, Chewing Gum Bases and Related Substances
§ 172.615 Chewing gum base.
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°-99 °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 °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.php. Petroleum wax................ Complying with § 172.886. Petroleum wax synthetic...... Complying with § 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 °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 °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 °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 °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°-88 °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 °C-96 °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 °C, and a viscosity of 23-66 poises at 25 °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. °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 °C, and a color of M or paler.Rice bran wax.................. Complying with § 172.890.Stearic acid................... Complying with § 172.860.Sodium and potassium stearates. Complying with § 172.863.------------------------------------------------------------------------ Terpene Resins------------------------------------------------------------------------Synthetic resin................ Consisting of polymers of αpinene, βpinene, 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 α- pinene; softening point minimum 155 °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.------------------------------------------------------------------------
