21 CFR 177.1200 - Cellophane.

View all text of Subpart B [§ 177.1010 - § 177.2000]

§ 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.

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.	N-Acyl sarcosines where the acyl group is lauroyl or stearoyl	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		n-Butyl acetate	0.1 percent.	n-Butyl alcohol	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, sulfonated, sodium salt		Cellulose acetate butyrate		Cellulose acetate propionate		Cetyl alcohol		Clay, natural		Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil fatty acid (C12-C18) diethanolamine soap, and diethanolamine mixture having total alkali (calculated as potassium hydroxide) of 16-18% and having an acid number of 25-35	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.	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.	Dimethyldialkyl (C8-C18) ammonium chloride	0.005 percent for use only as a flocculant for slip agents.	Di-n-ocyltin bis (2-ethylhexyl maleate)	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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.), and an acid value of 10 maximum	0.5 percent.	N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide)		Disodium EDTA		Distearic acid ester of di(hydroxyethyl) diethylenetriamine monoacetate	0.06 percent.	N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide)		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		n-Octyl alcohol	For use only as a defoaming agent in the manufacture of cellophane base sheet.	Olefin copolymers complying with § 177.1520		Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16 to C18)		Oleic acid, sulfonated, sodium salt		Oleyl palmitamide		N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl-aminoethyl)oleamide)		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.	n-Propyl acetate	Residue limit 0.1 percent.	n-Propyl alcohol	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 m-bisulfite		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.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, 1999; 87 FR 31089, May 20, 2022]