Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 3 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
/ PART 177 - INDIRECT FOOD ADDITIVES: POLYMERS
/ Subpart B - Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces / § 177.1200 Cellophane.
§ 177.1200 Cellophane.
Cellophane may be safely used for packaging food in accordance with the following prescribed conditions:
(a) Cellophane consists of a base sheet made from regenerated cellulose to which have been added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties.
(b) Subject to any limitations prescribed in this part, the optional substances used in the base sheet and coating may include:
(1) Substances generally recognized as safe in food.
(2) Substances for which prior approval or sanctions permit their use in cellophane, under conditions specified in such sanctions and substances listed in § 181.22 of this chapter.
(3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of cellophane.
(4) Substances named in this section and further identified as required.
(c) List of substances:
| List of substances | Limitations (residue and limits of addition expressed as percent by weight of finished packaging cellophane) |
|---|---|
| Acrylonitrile-butadiene copolymer resins | As the basic polymer. |
| Acrylonitrile-butadiene-styrene copolymer resins | Do. |
| Acrylonitrile-styrene copolymer resins | Do. |
| Acrylonitrile-vinyl chloride copolymer resins | Do. |
| For use only as release agents in coatings at levels not to exceed a total of 0.3 percent by weight of the finished packaging cellophane. | |
| Alkyl ketene dimers identified in § 176.120 of this chapter | |
| Aluminum hydroxide | |
| Aluminum silicate | |
| Ammonium persulfate | |
| Ammonium sulfate | |
| Behenamide | |
| Butadiene-styrene copolymer | As the basic polymer. |
| 1,3-Butanediol | |
| 0.1 percent. | |
| Do. | |
| Calcium ethyl acetoacetate | |
| Calcium stearoyl-2-lactylate identified in § 172.844 of this chapter | Not to exceed 0.5 percent weight of cellophane. |
| Carboxymethyl hydroxyethylcellulose polymer | |
| Castor oil, hydrogenated | |
| Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol polyester | As the basic polymer. |
| Castor oil phthalate, hydrogenated | Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. |
| Castor oil, sulfonated, sodium salt | |
| Cellulose acetate butyrate | |
| Cellulose acetate propionate | |
| Cetyl alcohol | |
| Clay, natural | |
| Coconut oil fatty acid (C | For use only as an adjuvant employed during the processing of cellulose pulp used in the manufacture of cellophane base sheet. |
| Copal resin, heat processed | As basic resin. |
| Damar resin | |
| Defoaming agents identified in § 176.200 of this chapter | |
| Dialkyl ketones where the alkyl groups are lauryl or stearyl | Not to exceed a total of 0.35 percent. |
| Dibutylphthalate | Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. |
| Dicyclohexyl phthalate | Do. |
| Diethylene glycol ester of the adduct of terpene and maleic anhydride | |
| Di(2-ethylhexyl) adipate | |
| Di(2-ethylhexyl) phthalate | Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. |
| Diisobutyl phthalate | Do. |
| Dimethylcyclohexyl phthalate | Do. |
| Dimethyldialkyl (C | 0.005 percent for use only as a flocculant for slip agents. |
| Di- | For use only as a stabilizer at a level not to exceed 0.55 percent by weight of the coating solids in vinylidene chloride copolymer waterproof coatings prepared from vinylidene chloride copolymers identified in this paragraph, provided that such vinylidene chloride copolymers contain not less than 90 percent by weight of polymer units derived from vinylidene chloride. |
| N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine and N-oleoyl-N′linoleoylethylene-diamine mixture produced when tall oil fatty acids are made to react with ethylenediamine such that the finished mixture has a melting point of 212°-228 °F., as determined by ASTM method D127-60 (“Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax” (Revised 1960), which is incorporated by reference; copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for inspection 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: | 0.5 percent. |
| Disodium EDTA | |
| Distearic acid ester of di(hydroxyethyl) diethylenetriamine monoacetate | 0.06 percent. |
| Epoxidized polybutadiene | For use only as a primer subcoat to anchor surface coatings to the base sheet. |
| Erucamide | |
| Ethyl acetate | |
| Ethylene-vinyl acetate copolymers complying with § 177.1350 | |
| 2-Ethylhexyl alcohol | 0.1 percent for use only as lubricant. |
| Fatty acids derived from animal and vegetable fats and oils, and the following salts of such acids, single or mixed: Aluminum, ammonium, calcium, magnesium, potassium, sodium | |
| Ferrous ammonium sulfate | |
| Fumaric acid | |
| Glycerin-maleic anhydride | As the basic polymer. |
| Glycerol diacetate | |
| Glycerol monoacetate | |
| Hydroxyethyl cellulose, water-insoluble | |
| Hydroxypropyl cellulose identified in § 172.870 of this chapter | |
| Isopropyl acetate | Residue limit 0.1 percent |
| Isopropyl alcohol | Do. |
| Itaconic acid | |
| Lanolin | |
| Lauryl alcohol | |
| Lauryl sulfate salts: ammonium, magnesium, potassium, sodium | |
| Maleic acid | 1 percent. |
| Maleic acid adduct of butadienestyrene copolymer | |
| Melamine formaldehyde | As the basic polymer. |
| Melamine-formaldehyde modified with one or more of the following: Butyl alcohol, diaminopropane, diethylenetriamine, ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-ethylamine, imino-bis-propylamine, methyl alcohol, polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane, sulfanilic acid, tetraethylenepentamine, triethanolamine, triethylenetetra-mine | As the basic polymer, and used as a resin to anchor coatings to substrate. |
| Methyl ethyl ketone | Residue limit 0.1 percent |
| Methyl hydrogen siloxane | 0.1 percent as the basic polymer. |
| α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1α-methylstyrene to 3 vinyltoluene) | |
| Mineral oil, white | |
| Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS Reg. No. 62362-49-6) | For use only as a release agent at a level not to exceed 0.6 percent by weight of coatings for cellophane. |
| Naphthalenesulfonic acid-formaldehyde condensate, sodium salt | 0.1 percent, for use only as an emulsifier. |
| Nitrocellulose, 10.9 percent-12.2 percent nitrogen | |
| Nylon resins complying with § 177.1500 | |
| For use only as a defoaming agent in the manufacture of cellophane base sheet. | |
| Olefin copolymers complying with § 177.1520 | |
| Oleic acid reacted with | |
| Oleic acid, sulfonated, sodium salt | |
| Oleyl palmitamide | |
| Paraffin, synthetic, complying with § 175.250 of this chapter | |
| Pentaerythritol tetrastearate | 0.1 percent. |
| Polyamide resins derived from dimerized vegetable oil acids (containing not more than 20 percent of monomer acids) and ethylenediamine as the basic resin | For use only in cellophane coatings that contact food at temperatures not to exceed room temperature. |
| Polyamide resins having a maximum acid value of 5 and a maximum amine value of 8.5 derived from dimerized vegetable oil acids (containing not more than 10 percent monomer acids), ethylenediamine, and 4,4-bis(4-hydroxyphenyl)pentanoic acid (in an amount not to exceed 10 percent by weight of said polyamide resins) | As the basic resin, for use only in coatings that contact food at temperatures not to exceed room temperature provided that the concentration of the polyamido resins in the finished food-contact coating does not exceed 5 milligrams per square inch of food-contact surface. |
| Polybutadiene resin (molecular weight range 2,000-10,200; bromine number range 210-320) | For use only as an adjuvant in vinylidene chloride copolymer coatings. |
| Polycarbonate resins complying with § 177.1580 | |
| Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride, and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C-92 °C, and a color of K or paler | |
| Polyethylene | |
| Polyethyleneaminostearamide ethyl sulfate produced when stearic acid is made to react with equal parts of diethylenetriamine and triethylenetetramine and the reaction product is quaternized with diethyl sulfate | 0.1 percent. |
| Polyethylene glycol (400) monolaurate | |
| Polyethylene glycol (600) monolaurate | |
| Polyethylene glycol (400) monooleate | |
| Polyethylene glycol (600) monooleate | |
| Polyethylene glycol (400) monostearate | |
| Polyethylene glycol (600) monostearate | |
| Polyethylene, oxidized: complying with the identity prescribed in § 177.1620(a) | |
| Polyethylenimine | As the basic polymer, for use as a resin to anchor coatings to the substrate and for use as an impregnant in the food-contact surface of regenerated cellulose sheet in an amount not to exceed that required to improve heat-sealable bonding between coated and uncoated sides of cellophane. |
| Polyisobutylene complying with § 177.1420 | |
| Polyoxypropylene-polyoxyethylene block polymers (molecular weight 1,900-9,000) | For use as an adjuvant employed during the processing of cellulose pulp used in the manufacture of cellophane base sheet. |
| Polypropylene complying with § 177.1520 | |
| Polystyrene | As the basic polymer. |
| Polyvinyl acetate | Do. |
| Polyvinyl alcohol (minimum viscosity of 4 percent aqueous solution at 20 °C of 4 centipoises) | |
| Polyvinyl chloride | As the basic polymer. |
| Polyvinyl stearate | Do. |
| Residue limit 0.1 percent. | |
| Do. | |
| Rapeseed oil, blown | |
| Rosins and rosin derivatives as provided in § 178.3870 of this chapter | |
| Rubber, natural (natural latex solids) | |
| Silica | |
| Silicic acid | |
| Sodium | |
| Sodium dioctyl sulfosuccinate | |
| Sodium dodecylbenzenesulfonate | |
| Sodium lauroyl sarcosinate | 0.35 percent; for use only in vinylidene chloride copolymer coatings. |
| Sodium oleyl sulfate-sodium cetyl sulfate mixture | For use only as an emulsifier for coatings; limit 0.005 percent where coating is applied to one side only and 0.01 percent where coating is applied to both sides. |
| Sodium silicate | |
| Sodium stearoyl-2-lactylate identified in § 172.846 of this chapter | Not to exceed 0.5 percent weight of cellophane. |
| Sodium sulfate | |
| Sodium sulfite | |
| Spermaceti wax | |
| Stannous oleate | |
| 2-Stearamido-ethyl stearate | |
| Stearyl alcohol | |
| Styrene-maleic anhydride resins | As the basic polymer. |
| Terpene resins identified in § 172.615 of this chapter | |
| Tetrahydrofuran | Residue limit of 0.1 percent. |
| Titanium dioxide | |
| Toluene | Residue limit of 0.1 percent. |
| Toluene sulfonamide formaldehyde | 0.6 percent as the basic polymer. |
| Triethylene glycol | |
| Triethylene glycol diacetate, prepared from triethylene glycol containing not more than 0.1 percent of diethylene glycol | |
| 2,2,4-Trimethyl-1,3 pentanediol diisobutyrate | For use only in cellophane coatings and limited to use at a level not to exceed 10 percent by weight of the coating solids except when used as provided in § 178.3740 of this chapter |
| Urea (carbamide) | |
| Urea formaldehyde | As the basic polymer. |
| Urea formaldehyde modified with methanol, ethanol, butanol diethylenetriamine, triethylenetetramine, tetraethylenepenta-mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-ethylamine, imino-bis-propylamine, imino-bis-butylamine, diaminopropane, diaminobutane, aminomethylsulfonic acid, polyamines made by reacting ethylenediamine or trimethylenediamine with dichlorethane or dichloropropane | As the basic polymer, and used as a resin to anchor coatings to the substrate. |
| Vinyl acetate-vinyl chloride copolymer resins | As the basic polymer. |
| Vinyl acetate-vinyl chloride-maleic acid copolymer resins | Do. |
| Vinylidene chloride copolymerized with one or more of the following: Acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, ethyl methacrylate, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride | Do. |
| Vinylidene chloride-methacrylate decyloctyl copolymer | Do. |
| Wax, petroleum, complying with § 178.3710 of this chapter |
(d) Any optional component listed in this section covered by a specific food additive regulation must meet any specifications in that regulation.
(e) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.