21 C.F.R. § 172.615
Current through September 30, 2024
The food additive chewing gum base may be safely used in the manufacture of chewing gum in accordance with the following prescribed conditions:
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 solvent-free resin extract of Massaranduba balata) | Manilkara huberi (Ducke) Chevalier. |
| 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 and latex solids) | Hevea brasiliensis. |
| Synthetic Specifications | |
| Butadiene-styrene rubber | Basic polymer. |
| Isobutylene-isoprene copolymer (butyl rubber) | Do. |
| 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.html. |
| 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 dimerized rosin | Having an acid number of 3-8, a minimum drop-softening point of 109 °C, and a color of M or paler. |
| Glycerol ester of partially hydrogenated gum or wood rosin | Having an acid number of 3-10, a minimum drop-softening point of 79 °C, and a color of N or paler. |
| Glycerol ester of polymerized rosin | Having an acid number of 3-12, a 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 rosin | Having an acid number of 2-12, a 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, partially hydrogenated | Having an acid number of 4-8, a 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 partially hydrogenated gum or wood rosin | Having an acid number of 7-18, a minimum drop-softening point of 102 °C, and a color of K or paler. |
| Pentaerythritol ester of gum or wood rosin | Having an acid number of 6-16, a 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 [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 °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. |
21 C.F.R. §172.615