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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2016]
[CITE: 21CFR177.1200]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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

Sec. 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 resinsAs 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 stearoylFor 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 copolymerAs the basic polymer.
1,3-Butanediol
n-Butyl acetate0.1 percent.
n-Butyl alcohol Do.
Calcium ethyl acetoacetate
Calcium stearoyl-2-lactylate identified in 172.844 of this chapterNot 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 polyesterAs the basic polymer.
Castor oil phthalate, hydrogenatedAlone 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 (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 25-35For use only as an adjuvant employed during the processing of cellulose pulp used in the manufacture of cellophane base sheet.
Copal resin, heat processedAs basic resin.
Damar resin
Defoaming agents identified in 176.200 of this chapter
Dialkyl ketones where the alkyl groups are lauryl or stearylNot to exceed a total of 0.35 percent.
DibutylphthalateAlone 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) phthalateAlone or in combination with other phthalates where total phthalates do not exceed 5 percent.
Diisobutyl phthalate Do.
Dimethylcyclohexyl phthalate Do.
Dimethyldialkyl (C8-C18) ammonium chloride0.005 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 212deg. -228 deg. 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 maximum0.5 percent.
N,N'-Dioleoylethylenediamine (N,N'-ethylenebisoleamide)
Disodium EDTA
Distearic acid ester of di(hydroxyethyl) diethylenetriamine monoacetate0.06 percent.
N,N'-Distearoylethylenediamine (N,N'-ethylenebis stearamide)
Epoxidized polybutadieneFor 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 alcohol0.1 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 anhydrideAs the basic polymer.
Glycerol diacetate
Glycerol monoacetate
Hydroxyethyl cellulose, water-insoluble
Hydroxypropyl cellulose identified in 172.870 of this chapter
Isopropyl acetateResidue limit 0.1 percent
Isopropyl alcohol Do.
Itaconic acid
lanolin
Lauryl alcohol
Lauryl sulfate salts: ammonium, magnesium, potassium, sodium
Maleic acid1 percent.
Maleic acid adduct of butadienestyrene copolymer
Melamine formaldehydeAs 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-mineAs the basic polymer, and used as a resin to anchor coatings to substrate.
Methyl ethyl ketoneResidue limit 0.1 percent
Methyl hydrogen siloxane0.1 percent as the basic polymer.
[alpha]-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1[alpha]-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 salt0.1 percent, for use only as an emulsifier.
Nitrocellulose, 10.9 percent-12.2 percent nitrogen
Nylon resins complying with 177.1500
n-Octyl alcoholFor 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 tetrastearate0.1 percent.
Polyamide resins derived from dimerized vegetable oil acids (containing not more than 20 percent of monomer acids) and ethylenediamine as the basic resinFor 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 deg. C-92 deg. 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 sulfate0.1 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)
PolyethylenimineAs 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
PolystyreneAs the basic polymer.
Polyvinyl acetate Do.
Polyvinyl alcohol (minimum viscosity of 4 percent aqueous solution at 20 deg. C of 4 centipoises)
Polyvinyl chlorideAs the basic polymer.
Polyvinyl stearate Do.
n-Propyl acetateResidue 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 sarcosinate0.35 percent; for use only in vinylidene chloride copolymer coatings.
Sodium oleyl sulfate-sodium cetyl sulfate mixtureFor 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 chapterNot 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 resinsAs the basic polymer.
Terpene resins identified in 172.615 of this chapter
TetrahydrofuranResidue limit of 0.1 percent.
Titanium dioxide
TolueneResidue limit of 0.1 percent.
Toluene sulfonamide formaldehyde0.6 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 diisobutyrateFor 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 formaldehydeAs 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 dichloropropaneAs the basic polymer, and used as a resin to anchor coatings to the substrate.
Vinyl acetate-vinyl chloride copolymer resinsAs 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.

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