Resinous and polymeric coatings may be safely used as the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions:
(a) The coating is applied as a continuous film over one or both sides of a base film produced from one or more of the basic olefin polymers complying with Sec. 177.1520 of this chapter. The base polyolefin film may contain optional adjuvant substances permitted for use in polyolefin film by applicable regulations in parts 170 through 189 of this chapter.
(b) The coatings are formulated from optional substances which are:
(1) Substances generally recognized as safe for use in or on food.
(2) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, by prior sanctions, or approvals.
(3) Substances identified in this paragraph (b)(3) and subject to such limitations as are provided: ------------------------------------------------------------------------
(i) Resins and polymers:
Acrylic acid polymer and its ethyl or
methyl esters.
Acrylamide copolymerized with ethyl
acrylate and/or styrene and/or
methacrylic acid, and the copolymer
subsequently reacted with
formaldehyde and butanol.
Butadiene-acrylonitrile copolymer....
Butadiene-acrylonitrile-styrene
terpolymer.
Butyl rubber.........................
N,N'-Diphenyl-p-phenylenediamine..... For use only as a
polymerization inhibitor in 2-
sulfoethyl methacrylate,
sodium salt.
2-Ethylhexyl acrylate copolymerized
with one or more of the following:
Acrylonitrile......................
Itaconic acid......................
Methacrylonitrile..................
Methyl acrylate....................
Methyl methacrylate................
4,4'-
Isopropylidenediphenolepichlorohydri
n average molecular weight 900.
Melamine-formaldehyde as the basic
polymer or chemically modified with
methyl alcohol.
Methacrylic acid and its ethyl or
methyl esters copolymerized with one
or more of the following:
Acrylic acid.......................
Ethyl acrylate.....................
Methyl acrylate....................
[alpha]-Methyl styrene polymer.......
[alpha]-Methylstyrene-vinyltoluene For use only in coatings that
copolymer resins (molar ratio 1 contact food under conditions
[alpha]-methylstyrene to 3 of use D, E, F, or G described
vinyltoluene). in table 2 of Sec. 176.170(c)
of this chapter, provided that
the concentration of [alpha]-
methylstyrene-vinyltoluene
copolymer resins in the
finished food-contact coating
does not exceed 1.0 milligram
per square inch of food-
contact surface.
Petroleum alicyclic hydrocarbon As defined in Sec. 176.170 of
resins. this chapter. Blended with
butyl rubber for use as a
component of coatings on
polyolefin fabric for bulk
packaging of raw fruits and
vegetables and used at a level
not to exceed 30 percent by
weight of the total coating
solids.
Polyamide resins (CAS Reg. No. 68139- For use only in coatings for
70-8), as the basic resin, derived polypropylene films that
from: contact food at temperatures
not to exceed room
temperature.
Dimerized vegetable oil or tall oil
acids containing not more than 20
percent of monomer acids.
Azelaic acid (CAS Reg. No. 123-99-
9) in an amount not to exceed 3.7
percent by weight of the polyamide
resin.
Ethylenediamine (CAS Reg. No. 107-
15-3).
Piperazine (CAS Reg. No. 110-85-0)
in an amount not to exceed 6.4
percent by weight of the polyamide
resin.
Polyamide resins, derived from For use only in coatings for
dimerized vegetable oil acids polyolefin films that contact
(containing not more than 20% of food at temperatures not to
monomer acids) and ethylenediamine, exceed room temperature.
as the basic resin.
Polyamide resins having a maximum For use only in coatings that
acid value of 5 and a maximum amine contact food at temperatures
value of 8.5 derived from dimerized not to exceed room temperature
vegetable oil acids (containing not provided that the
more than 10 percent of monomer concentration of the polyamide
acids), ethylenediamine, and 4,4-bis resins in the finished food-
(4-hydroxyphenyl) pentanoic acids contact coating does not
(in an amount not to exceed 10 exceed 5 milligrams per square
percent by weight of said polyamide inch of food-contact surface.
resins); as the basic resin.
Polyester resins formed by reaction
of one or more of the following
polybasic acids and monobasic acids
with one or more of the following
polyhydric alcohols:
Polybasic acids:
Adipic...........................
Azelaic.......................... For use in forming polyester
resins intended for use in
coatings that contact food
only of the type identified in
Sec. 176.170(c) of this
chapter, table 1, under
Category VIII, and under
conditions of use E, F, or G,
described in table 2 of Sec.
176.170(c) of this chapter.
Dimerized fatty acids derived
from:
Animal, marine or vegetable
fats and oils.
Tall oil.......................
Fumaric..........................
Isophthalic......................
Maleic...........................
o-Phthalic.......................
Sebacic..........................
Terephthalic.....................
Trimellitic......................
Monobasic acids:
Fatty acids derived from:
Animal, marine, or vegetable
fats and oils.
Gum rosin...................... As defined in Sec. 178.3870 of
this chapter. For use in
forming polyester resins
intended for use in coatings
that contact food only of the
type identified in Sec.
176.170(c) of this chapter,
table 1, under Category VIII,
and under conditions of use E,
F, or G described in table 2
of Sec. 176.170(c) of this
chapter.
Polyhydric alcohols:
1,3-Butylene glycol..............
Diethylene glycol................
2,2-Dimethyl-1,3-propanediol.....
Dipropylene glycol...............
Ethylene glycol..................
Glycerol.........................
Mannitol.........................
[alpha]-Methyl glucoside.........
Pentaerythritol..................
Propylene glycol.................
Sorbitol.........................
Trimethylol ethane...............
Trimethylol propane..............
Polyethylenimine..................... For use only as a primer
subcoat to anchor epoxy
surface coatings to the base
sheet.
Polystyrene..........................
Polyvinyl acetate....................
Polyvinyl chloride................... ...............................Siloxanes and silicones: platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 150 parts per million.
containing dimethylpolysiloxane (CAS
Reg. No. 68083-18-1 and CAS Reg. No.
68083-19-2) with methylhydrogen
polysiloxane (CAS Reg. No. 63148-57-2)
and dimethylmethylhydrogen
polysiloxane (CAS Reg. No. 68037-59-
2). The following substances may be
used as optional polymerization
inhibitors:.
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg.
No. 107-54-0), at a level not to
exceed 0.53 weight percent;.
1-Ethynylcyclohexene (CAS Reg. No.
931-49-7), at a level not to exceed
0.64 weight percent;.
Bis(methoxymethyl)ethyl maleate
(CAS Reg. No. 102054-10-4), at a
level not to exceed 1.0 weight
percent;.
Methylvinyl cyclosiloxane (CAS Reg.
No. 68082-23-5); and.
Tetramethyltetravinylcyclotetrasiloxa
ne (CAS Reg. No. 2554-06-5)..Siloxanes and silicones; platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 100 parts per million. For use
containing dimethylpolysiloxane (CAS only as a surface coating
Reg. Nos. 68083-19-2 and 68083-18-1), under the following
with methyl hydrogen polysiloxane (CAS conditions:
Reg. No. 63148-57-2). Dimethyl maleate 1. In coatings for olefin
(CAS Reg. No. 624-48-6) and vinyl polymers provided the coating
acetate (CAS Reg. No. 108-05-4) may be contacts food only of the
used as optional polymerization types identified in Sec.
inhibitors. 176.170(c) of this chapter,
table 1, under Types I, II,
VI, and VII-B when used under
conditions of use E, F, and G
described in table 2 in Sec.
176.170(c) of this chapter.
2. In coatings for olefin
polymers provided the coating
contacts food only of the
types identified in Sec.
176.170(c) of this chapter,
table 1, under Types III, IV,
V, VII-A, VIII, and IX when
used under conditions of use A
through H described in table 2
in Sec. 176.170(c) of this
chapter.Siloxanes and silicones; platinum- Platinum content not to exceed
catalyzed reaction product of vinyl- 100 parts per million. For use
containing dimethylpolysiloxane (CAS only as a release coating for
Reg. Nos. 68083-19-2 and 68083-18-1), pressure sensitive adhesives.
with methyl hydrogen polysiloxane (CAS
Reg. No. 63148-57-2). Dimethyl maleate
(CAS Reg. No. 624-48-6), vinyl acetate
(CAS Reg. No. 108-05-4), dibutyl
maleate (CAS Reg. No. 105-76-0) and
diallyl maleate (CAS Reg. No. 999-21-
3) may be used as optional
polymerization inhibitors. The polymer
may also contain C16-C18 olefins (CAS
Reg. No. 68855-60-7) as a control
release agent.
Styrene copolymerized with one or
more of the following:
Acrylonitrile......................
[alpha]-Methyl styrene.............
Styrene polymers made by the For use only in contact with
polymerization of any combination of foods of Types IV-A, V, and
styrene or alpha methyl styrene with VII in table 1 of Sec.
acrylic acid, methacrylic acid, 2- 176.170(c) of this chapter,
ethyl hexyl acrylate, methyl under use conditions E through
methacrylate, and butyl acrylate. G in table 2 of Sec.
The styrene and alpha methyl 176.170(c), and with foods of
styrene, individually, may Types VIII and IX without use
constitute from 0 to 80 weight temperature restriction.
percent of the polymer. The other
monomers, individually, may be from
0 to 40 weight percent of the
polymer. The polymer number average
molecular weight (Mn) shall be at
least 2,000 (as determined by gel
permeation chromatography). The acid
number of the polymer shall be less
than 250. The monomer content shall
be less than 0.5 percent.
Styrene-isobutylene copolymer........
Terpene resins consisting of polymers
of [alpha]-pinene, [beta]-pinene,
and/or dipentene; acid value less
than 5, saponification number less
than 5, and color less than 4 on the
Gardner scale as measured in 50
percent mineral spirits solution.
2-Sulfoethyl methacrylate, sodium For use only in copolymer
salt Chemical Abstracts Service No. coatings under conditions of
1804-87-1]. use E, F, and G described in
table 2 of Sec. 176.170(c) of
this chapter and limited to
use at a level not to exceed
2.0 percent by weight of the
dry copolymer coating.
Vinyl chloride-acetate, hydroxyl-
modified copolymer or maleic acid-
modified copolymer.
Vinyl chloride copolymerized with one
or more of the following:
Acrvlonitrile......................
Vinyl acetate......................
Vinylidene chloride................
Vinylidene chloride copolymerized
with one or more of the following:
Acrylic acid and its methyl, ethyl,
propyl, butyl, or octyl esters.
Acrylonitrile......................
Itaconic acid......................
Methacrylic acid and its methyl,
ethyl, propyl, butyl, or octyl
esters.
Methacrylonitrile..................
Vinyl chloride.....................(ii) Plasticizers:
Acetyl tributyl citrate..............
Acetyl triethyl citrate..............
Butyl phthalyl butyl glycolate.......
Butyl stearate.......................
Dibutyl sebacate.....................
Diethyl phthalate....................
2-Ethylhexyl diphenyl phosphate......
Ethyl phthalyl ethyl glycolate.......
Glycerol monooleate.................. ...............................
Glycerol triacetate..................
Triethyl citrate.....................(iii) Adjuvants (release agents, waxes,
and dispersants):
Acetone..............................
Amides (unsubstituted) of fatty acids
from vegetable or animal oils.
n-Butyl acetate......................
n-Butyl alcohol......................
Candelilla wax.......................
Carnauba wax.........................5-Chloro-2-methyl-4-isothiazolin-3-one For use only as an
(CAS Reg. No. 26172-55-4) and 2-methyl- antimicrobial agent in
4-isothiazolin-3-one (CAS Reg. No. emulsion-based silicone
2682-20-4) mixture, at a ratio of 3 coatings at a level not to
parts to 1 part, respectively, exceed 50 milligrams per
manufactured from methyl-3- kilogram (based on
mercaptopropionate (CAS Reg. No. 2935- isothiazolone active
90-2) and optionally containing ingredient) in the coating
magnesium nitrate (CAS Reg. No. 10377- formulation.
60-3) at a concentration equivalent to
the isothiazolone active ingredients
(weight/weight)..
1,2-Dibromo-2,4-dicyanobutane (CAS For use as an antimicrobial
Reg. No. 35691-65-7). agent at levels not to exceed
500 milligrams per kilogram in
emulsion-based silicone
coating.
Ethyl acetate........................
Fatty acids from vegetable or animal
oils and their aluminum, ammonium,
calcium, magnesium, and sodium salts.
Hexane...............................
Methyl ethyl ketone..................
N,N'-Dioleoylethylenediamine (CAS For use only in ionomeric
Reg. No. 110-31-6). resins complying with Sec.
177.1330 of this chapter and
in ethylene vinyl acetate
copolymers complying with Sec.
177.1350 of this chapter at a
level not to exceed 0.0085
milligram per square
centimeter (0.055 milligram
per square inch) in the
finished food-contact article.
Petroleum waxes conforming to
specifications included in a
regulation in subchapter B of this
chapter.
Polyvinyl alcohol, minimum viscosity For use only as a dispersing
of 4% aqueous solution at 20 C of 4 agent at levels not to exceed
centipoises and percent alcoholysis 6% of total coating weight in
of 87-100. coatings for pol-yolefin films
provided the finished
polyolefin films contact food
only of the types identified
in Sec. 176.170(c) of this
chapter, table 1, under Types
V, VIII, and IX.
Sodium dioctyl sulfosuccinate........
Sodium dodecylbenzenesulfonate.......
Sodium lauryl sulfate................
Sorbitan and sorbitol esters of fatty
acids from vegetable or animal oils.
Spermaceti wax.......................
Tetrahydrofuran......................
Toluene..............................(iv) Preservatives:
Silver chloride-coated titanium For use only as a preservative
dioxide. in latex emulsions at a level
not to exceed 2.2 parts per
million (based on silver ion
concentration) in the dry
coating.------------------------------------------------------------------------
(c) The coating in the finished form in which it is to contact food, when extracted with the solvent or solvents characterizing the type of food, and under conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 milligram per square inch of coated surface.
(d) Acrylonitrile copolymers identified in this section shall comply with the provisions of Sec. 180.22 of this chapter. [42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000]