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177.1200 Cellophane.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1200]

[Page 246-250]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 177_INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
 
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 Sec.  181.22 of this chapter.

[[Page 247]]

    (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:

------------------------------------------------------------------------
                                         Limitations (residue and limits
                                             of addition expressed as
           List of substances             percent by weight of finished
                                              packaging cellophane)
------------------------------------------------------------------------
Acrylonitrile-butadiene copolymer        As the basic polymer.
 resins.
Acrylonitrile-butadiene-styrene           Do.
 copolymer resins.
Acrylonitrile-styrene copolymer resins.   Do.
Acrylonitrile-vinyl chloride copolymer    Do.
 resins.
N-Acyl sarcosines where the acyl group   For use only as release agents
 is lauroyl or stearoyl.                  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 Sec.
  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  Not to exceed 0.5 percent
 in Sec.   172.844 of this chapter.       weight of cellophane.
Carboxymethyl hydroxyethylcellulose
 polymer.
Castor oil, hydrogenated...............
Castor oil phthalate with adipic acid    As the basic polymer.
 and fumaric acid-diethyl ene glycol
 polyester.
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 (C12-C18)         For use only as an adjuvant
 diethanolamide, coconut oil fatty acid   employed during the processing
 (C12-C18) diethanolamine soap, and       of cellulose pulp used in the
 diethanolamine mixture having total      manufacture of cellophane base
 alkali (calculated as potassium          sheet.
 hydroxide) of 16-18% and having an
 acid number of 25-35.
Copal resin, heat processed............  As basic resin.
Damar resin............................
Defoaming agents identified in Sec.
 176.200 of this chapter.
Dialkyl ketones where the alkyl groups   Not to exceed a total of 0.35
 are lauryl or stearyl.                   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 (C8-C18) ammonium        0.005 percent for use only as a
 chloride.                                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.

[[Page 248]]


N,N'-Dioleoyethylenediamine, N,N'-       0.5 percent.
 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[deg]-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 maximum.
N,N'-Dioleoylethylenediamine (N,N'-
 ethylenebisoleamide).
Disodium EDTA..........................
Distearic acid ester of                  0.06 percent.
 di(hydroxyethyl) diethylenetriamine
 monoacetate.
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 Sec.   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
 Sec.   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  As the basic polymer, and used
 or more of the following: Butyl          as a resin to anchor coatings
 alcohol, diaminopropane,                 to substrate.
 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.
Methyl ethyl ketone....................  Residue limit 0.1 percent
Methyl hydrogen siloxane...............  0.1 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       For use only as a release agent
 oxide) phosphates (CAS Reg. No. 62362-   at a level not to exceed 0.6
 49-6).                                   percent by weight of coatings
                                          for cellophane.
Naphthalenesulfonic acid-formaldehyde    0.1 percent, for use only as an
 condensate, sodium salt.                 emulsifier.
Nitrocellulose, 10.9 percent-12.2
 percent nitrogen.
Nylon resins complying with Sec.
 177.1500.
n-Octyl alcohol........................  For use only as a defoaming
                                          agent in the manufacture of
                                          cellophane base sheet.
Olefin copolymers complying with Sec.
 177.1520.
Oleic acid reacted with N-alkyl
 trimethylenediamine (alkyl C16 to C18).
Oleic acid, sulfonated, sodium salt....
Oleyl palmitamide......................

[[Page 249]]


N,N'-Oleoyl-stearylethylenediamine (N-
 (2-stearoyl-aminoethyl)oleamide).
Paraffin, synthetic, complying with
 Sec.   175.250 of this chapter.
Pentaerythritol tetrastearate..........  0.1 percent.
Polyamide resins derived from dimerized  For use only in cellophane
 vegetable oil acids (containing not      coatings that contact food at
 more than 20 percent of monomer acids)   temperatures not to exceed
 and ethylenediamine as the basic resin.  room temperature.
Polyamide resins having a maximum acid   As the basic resin, for use
 value of 5 and a maximum amine value     only in coatings that contact
 of 8.5 derived from dimerized            food at temperatures not to
 vegetable oil acids (containing not      exceed room temperature
 more than 10 percent monomer acids),     provided that the
 ethylenediamine, and 4,4-bis(4-          concentration of the polyamido
 hydroxyphenyl)pentanoic acid (in an      resins in the finished food-
 amount not to exceed 10 percent by       contact coating does not
 weight of said polyamide resins).        exceed 5 milligrams per square
                                          inch of food-contact surface.
Polybutadiene resin (molecular weight    For use only as an adjuvant in
 range 2,000-10,200; bromine number       vinylidene chloride copolymer
 range 210-320).                          coatings.
Polycarbonate resins complying with
 Sec.   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        0.1 percent.
 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.
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 Sec.
 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 Sec.
 177.1420.
Polyoxypropylene-polyoxyethylene block   For use as an adjuvant employed
 polymers (molecular weight 1,900-        during the processing of
 9,000).                                  cellulose pulp used in the
                                          manufacture of cellophane base
                                          sheet.
Polypropylene complying with Sec.
 177.1520.
Polystyrene............................  As the basic polymer.
Polyvinyl acetate......................   Do.
Polyvinyl alcohol (minimum viscosity of
 4 percent aqueous solution at 20
 [deg]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 Sec.   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        For use only as an emulsifier
 sulfate mixture.                         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   Not to exceed 0.5 percent
 in Sec.   172.846 of this chapter.       weight of cellophane.
Sodium sulfate.........................
Sodium sulfite.........................
Spermaceti wax.........................
Stannous oleate........................

[[Page 250]]


2-Stearamido-ethyl stearate............
Stearyl alcohol........................
Styrene-maleic anhydride resins........  As the basic polymer.
Terpene resins identified in Sec.
 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          For use only in cellophane
 diisobutyrate.                           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 Sec.
                                          178.3740 of this chapter
Urea (carbamide).......................
Urea formaldehyde......................  As the basic polymer.
Urea formaldehyde modified with          As the basic polymer, and used
 methanol, ethanol, butanol               as a resin to anchor coatings
 diethylenetriamine,                      to the substrate.
 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.
Vinyl acetate-vinyl chloride copolymer   As the basic polymer.
 resins.
Vinyl acetate-vinyl chloride-maleic       Do.
 acid copolymer resins.
Vinylidene chloride copolymerized with    Do.
 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.
Vinylidene chloride-methacrylate          Do.
 decyloctyl copolymer.
Wax, petroleum, complying with Sec.
 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 Sec.  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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1200


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