[Title 21 CFR 177.1200]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 177 - INDIRECT FOOD ADDITIVES: POLYMERS]
[Subpart B - Substances for Use as Basic Components of Single and Repeated]
[Sec. 177.1200 - Cellophane.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
3
1996-04-01
1996-04-01
false
Cellophane.
177.1200
Sec. 177.1200
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
FOOD FOR HUMAN CONSUMPTION
INDIRECT FOOD ADDITIVES: POLYMERS
Substances for Use as Basic Components of Single and Repeated
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.
(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-diethylene 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..........................
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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.
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 Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408), 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.
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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.
-Methylstyrene-vinyltoluene
copolymer resins (molar ratio 1 -methylstyrene to 3 vinyltoluene).
Mineral oil, white.....................
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......................
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.
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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........................
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]
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