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176.180 Components of paper and paperboard in contact with dry food.

Home > Regulations > Indirect food additives: Paper and paperboard components > 176.180 Components of paper and paperboard in contact with dry food.



[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: 21CFR176.180]

[Page 223-227]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table 
of Contents
 
 Subpart B_Substances for Use Only as Components of Paper and Paperboard
 
Sec.  176.180  Components of paper and paperboard in contact with dry 
food.

    The substances listed in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding dry 
food of the type identified in Sec.  176.170(c), table 1, under Type 
VIII, subject to the provisions of this section.
    (a) The substances are used in amounts not to exceed that required 
to accomplish their intended physical or technical effect, and are so 
used as to accomplish no effect in food other than that ordinarily 
accomplished by packaging.
    (b) The substances permitted to be used include the following:
    (1) Substances that by Sec.  176.170 and other applicable 
regulations in parts 170 through 189 of this chapter may be safely used 
as components of the uncoated or coated food-contact surface of paper 
and paperboard, subject to the provisions of such regulation.
    (2) Substances identified in the following list:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
Acrylamide polymer with sodium 2-        For use at a level not to
 acrylamido-2-methylpropane-sulfonate     exceed 0.015 weight percent of
 (CAS Reg. No. 38193-60-1).               dry fiber.
(2-Alkenyl) succinic anhydrides in
 which the alkenyl groups are derived
 from olefins which contain not less
 than 78 percent C30 and higher groups
 (CAS Reg. No. 70983-55-0)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy)       For use as a polymerization
 ethoxy]ethyl]disodium sulfosuccinate.    emulsifier and latex emulsion
                                          stabilizer at levels not to
                                          exceed 5 percent by weight of
                                          total emulsion solids.
Alkyl mono- and disulfonic acids,
 sodium salts (produced from n-alkanes
 in the range of C10-C18 with not less
 than 50 percent C14-C16)..
Aluminum and calcium salts of FD & C     Colorant.
 dyes on a substrate of alumina.
Ammonium nitrate.......................
Amylose................................
Barium metaborate......................  For use as preservative in
                                          coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative
 Registry No. 2634-33-5).                 in paper coating compositions
                                          and limited to use at a level
                                          not to exceed 0.02 mg/in\2\
                                          (0.0031 mg/cm\2\) of finished
                                          paper and paperboard.
N,N'-Bis(hydroxyethyl)lauramide........
Bis(trichloromethyl) sulfone C.A.        For use only as a preservative
 Registry No. 3064-70-8.                  in coatings.
Borax..................................  For use as preservative in
                                          coatings.
Boric acid.............................   Do.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
sec-Butyl alcohol......................
Butyl benzyl phthalate.................
Candelilla wax.........................
Carbon tetrachloride...................
Castor oil, polyoxyethylated (42 moles
 ethylene oxide)..
Cationic soy protein hydrolyzed          For use only as a coating
 (hydrolyzed soy protein isolate          adhesive, pigment structuring
 modified by treatment with 3-chloro-2-   agent, and fiber retention
 hydroxypropyl-trimethylammonium          aid.
 chloride).
Cationic soy protein (soy protein        For use only as a coating
 isolate modified by treatment with 3-    adhesive, pigment structuring
 chloro-2-hydroxypropyltrimethyl-         agent, and fiber retention
 ammonium chloride).                      aid.
Chloral hydrate........................  Polymerization reaction-control
                                          agent.
N-Cyclohexyl-p-toluene sulfonamide.....
2,5-Di-tert-butyl hydroquinone.........
Diethanolamine.........................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer
 No. 120-55-8).                           in polymeric substances.
Diethylene glycol monobutyl ether......
Diethylene glycol monoethyl ether......
Diethylenetriamine.....................

[[Page 224]]


N,N-Diisopropanolamide of tallow fatty
 acids..
N-[(dimethylamino)methyl]acrylamide
 polymer with acrylamide and styrene..
N,N-Dioleoylethylenediamine, N,N-
 dilinoeoyl- ethylenediamine, and N-
 oleoyl-N-linoleoyl-ethylenediamine
 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, and an acid value
 of 10 maximum. ASTM Method D127-60
 ``Standard Method of Test for Melting
 Point of Petrolatum and
 Microcrystalline Wax'' (Revised 1960)
 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..
Diphenylamine..........................
Dipropylene glycol dibenzoate (CAS Reg.  For use only as plasticizer in
 No. 27138-31-4).                         polymeric substances.
Disodium N-octadecylsulfosuccinamate...
tert-Dodecyl thioether of polyethylene
 glycol..
Erucamide (erucylamide)................
Ethanedial, polymer with tetrahydro-4-
 hydroxy-5-methyl-2(1H)pyrimidinone,
 propoxylated..
Ethylene oxide.........................  Fumigant in sizing.
Ethylene oxide adduct of mono-(2-
 ethylhexyl) o-phosphate..
Fatty acid (C12-C18) diethanolamide....
Fish oil fatty acids, hydrogenated,
 potassium salt..
Formaldehyde...........................
Glyceryl monocaprate...................
Glyceryl tribenzoate (CAS Reg. No. 614-  For use only as a plasticizer
 33-5).                                   in polymeric coatings.
Glyoxal................................
Glyoxal-urea-formaldehyde condensate     For use as an insolubilizer for
 (CAS Reg. No. 27013-01-0) formed by      starch in coatings.
 reaction in the molar ratio of
 approximately 47:33:15, respectively.
 The reaction product has a number
 average molecular weight of 27814 as determined by a
 suitable method.
Glyoxal-urea polymer (CAS Reg. No.       For use as an insolubilizer for
 53037-34-6).                             starch.
Hexamethylenetetramine.................  Polymerization crosslinking
                                          agent for protein, including
                                          casein. As neutralizing agent
                                          with myristochromic chloride
                                          complex and stearato-chromic
                                          chloride complex.
Hexylene glycol (2-methyl-2,4-
 pentanediol)..
Hydroabietyl alcohol...................
5-Hydroxymethoxymethyl-1-aza-3,7-        For use only as an
 dioxabicyclo[3.3.0] octane, 5-           antibacterial preservative.
 hydroxymethyl-1-aza-3,7-
 dioxabicyclo[3.3.0]octane, and 5-
 hydroxypoly-[methyleneoxy]methyl-1-aza-
 3,7-dioxabicyclo[3.3.0] octane mixture.
Imidazolium compounds, 2-(C17 and C17-   For use only at levels not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
Isopropanolamine hydrochloride.........
Isopropyl m- and p-cresol (thymol
 derived)..
Itaconic acid..........................
Maleic anhydride-diisobutylene
 copolymer, ammonium or sodium salt..
Melamine-formaldehyde modified with:     Basic polymer.
 Alcohols (ethyl, butyl, isobutyl,
 propyl, or isopropyl).
 Diethylenetriamine.
 Imino-bis-butylamine.
 Imino-bis-ethyleneimine.
 Imino-bis-propylamine.
 Polyamines made by reacting
 ethylenediamine or trimethylenediamine
 with dichloroethane or
 dichloropropane.
 Sulfanilic acid.
 Tetraethylenepentamine.
 Triethylenetetramine.
Methyl alcohol.........................
Methyl ethers of mono-, di-, and
 tripropylene glycol..
Methyl napthalene sulfonic acid-
 formaldehyde condensate, sodium salt..
Methylated poly(N-1,2-dihydroxyethylene- For use only only as an in
 1,3-imidazolidin-2-one).                 solubilizer for starch.

[[Page 225]]


Modified polyacrylamide resulting from   For use only as a dry strength
 an epichlorohydrin addition to a         and pigment retention aid
 condensate of formaldehyde-              agent employed prior to the
 dicyandiamide-diethylene triamine and    sheetforming operation in the
 which product is then reacted with       manufacture of paper and
 polyacrylamide and urea to produce a     paperboard and used at a level
 resin having a nitrogen content of 5.6   not to exceed 1 percent by
 to 6.3 percent and having a minimum      weight of dry fibers.
 viscosity in 56 percent-by-weight
 aqueous solution of 200 centipoises at
 25 [deg]C, as determined by LVT-series
 Brookfield viscometer using a No. 4
 spindle at 60 r.p.m. (or equivalent
 method).
Mono- and di(2-alkenyl)succinyl esters   For use only as an emulsifier.
 of polyethylene glycol containing not
 less than 90 percent of the diester
 product and in which the alkenyl
 groups are derived from olefins that
 contain not less than 95 percent of
 C15-C21 groups.
Monoglyceride citrate..................
Myristo chromic chloride complex.......
Napthalene sulfonic acid-formaldehyde
 condensate, sodium salt..
Nickel.................................
[beta]-Nitrostyrene....................  Basic polymer.
Octadecanoic acid, reaction products     For use prior to sheet forming
 with 2-[(2-aminoethyl)amino]ethanol      at levels not to exceed 12
 and urea (CAS Reg. No. 68412-14-6),      pounds per ton of paper.
 and the acetate salts thereof (CAS
 Reg. No. 68784-21-4), which may be
 emulsified with ethoxylated tallow
 alkyl amines (CAS Reg. No. 61791-26-2).
[alpha]-cis-9-Octadecenyl-omega-
 hydroxypoly (oxyethylene); the
 octadecenyl group is derived from
 oleyl alcohol and the
 poly(oxyethylene) content averages not
 less than 20 moles..
[alpha]-(p-Nonylphenyl)-omega-
 hydroxypoly (oxyethylene) sulfate,
 ammonium salt; the nonyl group is a
 propylene trimer isomer and the poly
 (oxyethylene) content averages 9 or 30
 moles..
Oleic acid reacted with N-alkyl-(C16-
 C18) trimethylenediamine..
Oxidized soy isolate having 50 to 70     For use as a binder adhesive
 percent of its cystine residues          component of coatings.
 oxidized to cysteic acid.
Petroleum alicyclic hydrocarbon resins,  For use as modifiers at levels
 or the hydrogenated product thereof,     up to 30 weight-percent of the
 complying with the identity prescribed   solids content of wax-polymer
 in Sec.   176.170(b)(2).                 blend coatings.
Petroleum hydrocarbon resins (produced
 by the catalytic polymerization and
 subsequent hydrogenation of styrene,
 vinyltoluene, and indene types from
 distillates of cracked petroleum
 stocks)..
Petroleum hydrocarbons, light and
 odorless..
o-Phthalic acid modified hydrolyzed soy
 protein isolate..
Pine oil...............................
Poly(2-aminoethyl acrylate nitrate-co-2-
 hydroxypropyl acrylate) complying with
 the identity described in Sec.
 176.170(a)..
Polyamide-epichloro hydrin modified
 resins resulting from the reaction of
 the initial caprolactam-itaconic acid
 product with diethylenetriamine and
 then condensing this prepolymer with
 epichlorohydrin to form a cationic
 resin having a nitrogen content of 11-
 15 percent and chlorine level of 20-23
 percent on a dry basis..
Polyamide-ethyleneimine-epichlorohydrin
 resin is prepared by reacting
 equimolar amounts of adipic acid and
 three amines (21 mole percent of 1,2-
 ethanediamine, 51 mole percent of N-(2-
 aminoethyl)-1,3-propanediamine, and 28
 mole percent of N, N'-1,2-
 ethanediylbis(1,3-propanediamine)) to
 form a basic polyamidoamine which is
 modified by reaction with
 ethyleneimine (5.5:1.0
 ethyleneimine:polyamidoamine). The
 modified polyamidoamine is reacted
 with a crosslinking agent made by
 condensing approximately 34 ethylene
 glycol units with
 (chloromethyl)oxirane, followed by pH
 adjustment with formic acid or
 sulfuric acid to provide a finished
 product as a formate (CAS Reg. No.
 114133-44-7) or a sulfate (CAS Reg.
 No. 167678-43-5), having a weight-
 average molecular weight of 1,300,000
 and a number-average molecular weight
 of 16,000..
Polyamide-ethyleneimine-epichlorohydrin
 resin (CAS Reg. No. 115340-77-7),
 prepared by reacting equimolar amounts
 of adipic acid and N-(2-aminoethyl)-
 1,2-ethanediamine to form a basic
 polyamidoamine which is modified by
 reaction with ethyleneimine, and
 further reacted with formic acid and
 (chloromethyl)oxirane-[alpha]-hydro-
 omega-hydroxypoly(oxy-1,2-ethanediyl)..

[[Page 226]]


Polybutene, hydrogenated; complying
 with the identity prescribed under
 Sec.   178.3740(b) of this chapter..
Poly [2-(diethylamino) ethyl
 methacrylate] phosphate..
Polyethylene glycol (200) dilaurate....
Polyethylene glycol monoisotridecyl      For use only as a surfactant at
 ether sulfate, sodium salt (CAS Reg.     levels not to exceed 3 percent
 No. 150413-26-6).                        in latex formulations used in
                                          pigment binders for paper and
                                          paperboard.
Polymers: Homopolymers and copolymers    Basic polymer.
 of the following monomers:
 Acrylamide.
 Acrylic acid and its methyl, ethyl,
 butyl, propyl, or octyl esters.
 Acrylonitrile.
 Butadiene.
 Crotonic acid.
 Cyclol acrylate.
 Decyl acrylate.
 Diallyl fumarate.
 Diallyl maleate.
 Diallyl phthalate.
 Dibutyl fumarate.
 Dibutyl itaconate.
 Dibutyl maleate.
 Di(2-ethylhexyl) maleate.
 Dioctyl fumarate.
 Dioctyl maleate.
 Divinylbenzene.
 Ethylene.
 2-Ethylhexyl acrylate.
 Fumaric acid.
 Glycidyl methacrylate.
 2-Hydroxyethyl acrylate.
 N-(Hydroxymethyl) acrylamide.
 Isobutyl acrylate.
 Isobutylene.
 Isoprene.
 Itaconic acid.
 Maleic anhydride and its methyl or
 butyl esters.
 Methacrylic acid and its methyl,
 ethyl, butyl, or propyl esters.
 Methylstyrene.
 Mono(2-ethylhexyl) maleate.
 Monoethyl maleate.
 5-Norbornene-2,3-dicarboxylic acid,
 mono-n-butyl ester.
 Styrene.
 Vinyl acetate.
 Vinyl butyrate.
 Vinyl chloride.
 Vinyl crotonate.
 Vinyl hexoate.
 Vinylidene chloride.
 Vinyl pelargonate.
 Vinyl propionate.
 Vinyl pyrrolidone.
 Vinyl stearate.
 Vinyl sulfonic acid.
Polymer prepared from urea, ethanedial,  For use only as a starch and
 formaldehyde, and propionaldehyde (CAS   protein reactant in paper and
 Reg. No. 106569 -82-8).                  paperboard coatings.
Polyoxyethylene (minimum 12 moles)
 ester of tall oil (30%-40% rosin
 acids)..
Polyoxypropylene-polyoxyethylene glycol
 (minimum molecular weight 1,900)..
Polyvinyl alcohol......................
Potassium titanate fibers produced by
 calcining titanium dioxide, potassium
 chloride, and potassium carbonate,
 such that the finished crystalline
 fibers have a nominal diameter of 0.20-
 0.25 micron, a length-to-diameter
 ratio of approximately 25:1 or
 greater, and consist principally of
 K2Ti4O9 and K2Ti 6O13..
Sodium diisobutylphenoxy diethoxyethyl
 sulfonate..
Sodium diisobutylphenoxy monoethoxy
 ethylsulfonate..
Sodium n-dodecylpolyethoxy (50 moles)
 sulfate..
Sodium isododecylphenoxypolyethoxy (40
 moles) sulfate..
Sodium N-methyl-N-oleyl taurate........
Sodium methyl siliconate...............

[[Page 227]]


Sodium nitrite.........................
Sodium polyacrylate....................
Sodium bis-tridecylsulfosuccinate......
Sodium xylene sulfonate................
Stearato chromic chloride complex......
Styrene-allyl alcohol copolymers.......
Styrene-methacrylic acid copolymer,
 potassium salt..
Tetraethylenepentamine.................  Polymerization cross-linking
                                          agent.
[alpha]-[p-(1,1,3,3-
 Tetramethylbutyl)phenyl]-omega
 hydroxypoly(oxyethylene) mixture of
 dihydrogen phosphate and monohydrogen
 phosphate esters and their sodium,
 potassium, and ammonium salts having a
 poly(oxyethylene) content averaging 6-
 9 or 40 moles..
[alpha]-[p-(1,1,3,3-
 Tetramethylbutyl)phenyl or p-
 nonylphenyl]-omega-hydroxypoly
 (oxyethylene) where nonyl group is a
 propylene trimer isomer..
Tetrasodium N-(1,2-dicarboxyethyl)-N-
 octadecyl sulfosuccinamate..
Toluene................................
Triethanolamine........................
Triethylenetetramine...................  Polymerization cross-linking
                                          agent.
Triethylenetetramine monoacetate,
 partially stearoylated..
Urea-formaldehyde chemically modified
 with:
 Alcohol (methyl, ethyl, butyl,
 isobutyl, propyl, or isopropyl).
 Aminomethylsulfonic acid.
 Diaminobutane.
 Diaminopropane.
 Diethylenetriamine.
 N,N'-Dioleoylethylenediamine.
 Diphenylamine.
 N,N'-Distearoylethylenediamine.
 Ethylenediamine.
 Guanidine.
 Imino-bis-butylamine.
 Imino-bis-ethylamine.
 Imino-bis-propylamine.
 N-Oleoyl-N'-stearoylethylenediamine.
 Polyamines made by reacting
 ethylenediamine or triethylenediamine
 with dichloroethane or
 dichloropropane.
 Tetraethylenepentamine.
 Triethylenetetramine.
Xylene.................................
Xylene sulfonic acid-formaldehyde
 condensate, sodium salt..
Zinc stearate..........................
------------------------------------------------------------------------


[42 FR 14554, Mar. 15, 1977]

    Editorial Note: For additional Federal Register citations affecting 
Sec.  176.180, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and on GPO Access.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 176, Section 180


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