[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.170]
[Page 185-210]
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. 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
Substances identified 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, packaging,
processing, preparing, treating, packing, transporting, or holding
aqueous and fatty foods, subject to the provisions of this section.
Components of paper and paperboard in contact with dry food of the type
identified under Type VIII of table 1 in paragraph (c) of this section
are subject to the provisions of Sec. 176.180.
(a) Substances identified in paragraph (a) (1) through (5) of this
section may be used as components of the food-contact surface of paper
and paperboard. Paper and paperboard products shall be exempted from
compliance with the extractives limitations prescribed in paragraph (c)
of this section: Provided, That the components of the food-contact
surface consist entirely of one or more of the substances identified in
this paragraph: And provided further, That if the paper or paperboard
when extracted under the conditions prescribed in paragraph (c) of this
section exceeds the limitations on extractives contained in paragraph
(c) of this section, information shall be available from manufacturing
records from which it is possible to determine that only substances
identified in this paragraph (a) are present in the food-contact surface
of such paper or paperboard.
(1) Substances generally recognized as safe in food.
(2) Substances generally recognized as safe for their intended use
in paper and paperboard products used in food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances that by regulation in parts 170 through 189 of this
chapter may be safely used without extractives limitations as components
of the uncoated or coated food-contact surface of paper and paperboard
in contact with aqueous or fatty food, subject to the provisions of such
regulation.
(5) Substances identified in this paragraph, as follows:
[[Page 186]]
------------------------------------------------------------------------
List of Substances Limitations
------------------------------------------------------------------------
Acetyl peroxide........................ For use only as polymerization
catalyst.
Acrylamide-methacrylic acid-maleic For use only as a retention aid
anhydride copolymers containing not employed prior to the sheet-
more than 0.2 percent of residual forming operation in the
acrylamide monomer and having an manufacture of paper and
average nitrogen content of 14.9 paperboard in such an amount
percent such that a 1 percent by that the finished paper and
weight aqueous solution has a minimum paperboard will contain the
viscosity of 600 centipoises at 75 additive at a level not in
deg.F, as determined by LVG-series excess of 0.05 percent by
Brookfield viscometer (or equivalent) weight of dry fibers in the
using a No. 2 spindle at 30 r.p.m. finished paper and paperboard.
Acrylamide-- For use only as a retention aid
methacrylyloxyethyltrimethylammonium and flocculant employed prior
methyl sulfate copolymer resins to the sheet-forming operation
containing not more than 10 molar in the manufacture of paper
percent of - and paperboard.
methacrylyloxyethyltrimethylammonium
methyl sulfate and containing less
than 0.2% of residual acrylamide
monomer.
Acrylic acid, sodium salt copolymer For use only in paper mill
with polyethyleneglycol allyl ether boilers.
(CAS Reg. No. 86830-15-1).
Acrylic acid copolymer with 2- For use only as a scale
acrylamido-2-methylpropane-sulfonic inhibitor prior to the sheet-
acid (CAS Reg. No. 40623-75-4) and/or forming operation in the
its ammonium/alkali metal mixed salts. manufacture of paper and
The copolymer is produced by poly- paperboard and used at a level
merization of acrylic acid and 2- not to exceed 1.0 kilogram
acrylamido-2-methylpropane-sulfonic (2.2 pounds) of copolymer per
acid in a weight ratio of 60/40, such 907 kilograms (1 ton) of dry
that a 28 percent by weight aqueous paper and paperboard fibers.
solution of the polymer has a
viscosity of 75-150 centipoises at 25
deg.C as determined by LV-series
Brookfield viscometer (or equivalent)
using a No. 2 spindle at 60 r.p.m.
Acrylonitrile polymer, reaction product For use only as a size promoter
with ethylenediamine sulfate having a and retention aid at a level
nitrogen content of 22.5-25.0 percent not to exceed 0.5 percent by
(Kjeldahl dry basis) and containing no weight of the dry paper and
more than 0.075 percent monomer as paperboard.
ethylenediamine. The finished resin in
a 24 percent by weight aqueous
solution has a viscosity of 1,000-
2,000 centipoises at 25 deg.C as
determined by LVT-series Brookfield
viscometer using a No. 4 spindle at 50
r.p.m. (or by other equivalent method).
Acrylonitrile polymer with styrene, 1. For use only as a sizing
reaction product with ethylenediamine material applied after the
acetate, having a nitrogen content of sheet-forming operation in the
7.4-8.3 percent (Kjeldahl dry basis) manufacture of paper and
and containing no more than 0.25 paperboard in such amount that
percent monomer as ethylenediamine. the paper and paperboard will
contain the additive at a
level not in excess of 0.25
percent by weight of the dry
paper and paperboard.
2. For use only as a sizing
material applied prior to the
sheet-forming operation in the
manufacture of paper and
paperboard in such amount that
the paper and paperboard will
contain the additive at a
level not in excess of 1.0
percent by weight of the dry
paper and paperboard.
1-Alkenyl olefins, containing not less For use only under the
than 72 percent of C30 and higher following conditions:
olefins. 1. In coatings for paper and
paperboard with food of Types
I, II, IV-B, and VII-B
described in table 1 of
paragraph (c) of this section
under conditions of use E, F,
and G described in table 2 of
paragraph (c) of this section.
2. In coatings for paper and
paperboard with food of Type
VIII described in table I of
paragraph (c) of this section
under conditions of use A
through H described in table 2
of paragraph (c) of this
section.
(2-Alkenyl) succinic anhydrides For use only as a sizing agent
mixture, in which the alkenyl groups employed prior to the sheet-
are derived from olefins which contain forming operation in the
not less than 95 percent of C15-C21 manufacture of paper and
groups. paperboard and limited to use
at a level not to exceed 1
percent by weight of the
finished dry paper and
paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic For use only as stabilizers
acid copolymers (CAS Reg. No. 27401-06- employed prior to the sheet-
5). forming operation in the
manufacture of paper and
paperboard.
tert-Alkyl(C8-C16)mercaptans........... For use only as polymerization-
control agent.
Aluminum acetate.......................
2-Amino-2-methyl-1-propanol (CAS Reg. For use as a dispersant for
No. 124-68-5). pigment suspension at a level
not to exceed 0.25 percent by
weight of pigment. The
suspension is used as a
component of coatings for
paper and paperboard under
conditions of use described in
paragraph (c) of this section,
table 2, conditions of use E
through G.
[[Page 187]]
Ammonium bis(N-ethyl-2- For use only as an oil and
perfluoroalkylsulfonamido ethyl) water repellant at a level not
phosphates, containing not more than to exceed 0.17 pound (0.09
15% ammonium mono (N-ethyl-2- pound of fluorine) per 1,000
perfluoroalkylsulfonamido ethyl) square feet of treated paper
phosphates, where the alkyl group is or paperboard of a sheet basis
more than 95% C8 and the salts have a weight of 100 pounds or less
fluorine content of 50.2% to 52.8% as per 3,000 square feet of paper
determined on a solids basis. or paperboard, and at a level
not to exceed 0.5 pound (0.26
pound of fluorine) per 1,000
square feet of treated paper
or paperboard having a sheet
basis weight greater than 100
lb. per 3,000 square feet as
determined by analysis for
total fluorine in the treated
paper or paperboard without
correction for any fluorine
that might be present in the
untreated paper or paperboard,
when such paper or paperboard
is used as follows:
1. In contact, under conditions
of use C, D, E, F, G, or H
described in table 2 of
paragraph (c) of this section,
with nonalcoholic food.
2. In contact with bakery
products of Type VII, VIII,
and IX described in table I of
paragraph (c) of this section
under good manufacturing
practices of commercial and
institutional baking.
Ammonium persulfate....................
Ammonium thiosulfate...................
Ammonium zirconium carbonate (CAS Reg. For use only as an
No. 32535-84-5) and its tartaric acid insolubilizer for binders used
adduct. in coatings for paper and
paperboard, and limited to use
at a level not to exceed 2.5
percent by weight of coating
solids.
Ammonium zirconium citrate (CAS Reg. For use as insolubilizers with
No. 149564-62-5), ammonium zirconium protein binders in coatings
lactate-citrate (CAS Reg. No. 149564- for paper and paperboard, at a
64-7), ammonium zirconium lactate (CAS level not to exceed 1.4
Reg. No. 149564-63-6). percent by weight of coating
solids.
Anionic polyurethane, produced by For use only as a surface
reacting the preliminary adduct formed sizing agent at a level not to
from the reaction of glyceryl exceed 0.1 percent by weight
monostearate and 2,4- of dry paper and paperboard.
toluenediisocyanate with not more than
10 mole percent N-methyldiethanolamine
and not less than 90 mole percent
dimethylolpropionic acid. The final
product is a 15 to 20 percent by
weight aqueous solution, having a
Brookfield viscosity of 25 to 100
centipoises at 24 deg.C (75 deg.F).
9,10-Anthraquinone (Chemical Abstracts For use only as a pulping aid
Service Registry No. 84-65-1) which in the alkaline pulping of
has a purity of not less than 98 lignocellulosic material at
percent. levels not to exceed 0.1
percent by weight of the raw
lignocellulosic material.
Aromatic petroleum hydrocarbon resin, For use only as modifiers in
hydrogenated (CAS Reg. No. 88526-47- wax polymer blend coatings for
0), produced by the catalytic paper and paperboard at a
polymerization of aromatic substituted level not to exceed 50 weight-
olefins from low boiling distillates percent of the coating solids
of cracked petroleum stocks with a under conditions of use E, F,
boiling point no greater than 220 and G identified in table 2 of
deg.C (428 deg.F), and the subsequent paragraph (c) of this section.
catalytic reduction of the resulting
aromatic petroleum hydrocarbon resin.
The resin meets the following
specifications: softening point 85
deg.C (185 deg.F) minimum, as
determined by ASTM Method E 28-67
(Reapproved 1982), ``Standard Test
Method for Softening Point by Ring-and-
Ball Apparatus,'' and aniline point 70
deg.C (158 deg.F) minimum, as
determined by ASTM Method D 611-82,
``Standard Test Methods for Aniline
Point and Mixed Aniline Point of
Petroleum Products and Hydrocarbon
Solvents,'' which are incorporated by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may
be obtained from the American Society
for Testing and Materials, 1916 Race
St., Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC.
Azo-bisisobutyronitrile................ For use only as polymerization
catalyst.
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 0.01 mg/in2
(0.0016 mg/cm\2\) of the
finished paper and paperboard.
Benzoyl peroxide....................... Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12- For use only as an adjuvant to
C18)amide. control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet
forming operation.
[[Page 188]]
Bis(methoxymethyl)tetrakis- For use only under the
[(octadecyloxy)-methyl]melamine resins following conditions:
having a 5.8-6.5 percent nitrogen 1. As a water repellant
content (CAS Reg. No. 68412-27-1). employed prior to the sheet-
forming operation in the
manufacture of paper and
paperboard in such amount that
the finished paper and
paperboard will contain the
additive at a level not in
excess of 1.6 percent by
weight of the finished dry
paper and paperboard fibers.
2. The finished paper and
paperboard will be used in
contact with nonalcoholic
foods only.
3. As a water repellant
employed after the sheet-
forming operation in the
manufacture of paper and
paperboard in such amount that
the finished paper and
paperboard will contain the
additive at a level not to
exceed 1.6 percent by weight
of the finished dry paper and
paperboard fibers. The
finished paper and paperboard
will be used only in contact
with food of Types I, II, IV-
B, VI, VII-B, and VIII
described in table 1 of
paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS For use only as an
Reg. No. 52-51-7). antimicrobial/preservative in
fillers, pigment slurries,
starch sizing solutions, and
latex coatings at levels not
to exceed 0.01 percent by
weight of those components.
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.
tert-Butyl hydroperoxide............... For use only as polymerization
catalyst.
tert-Butyl peroxide.................... Do.
Calcium isostearate.................... For use only with n-decyl
alcohol as a stabilizing
material for aqueous calcium
stearate dispersions intended
for use as components of
coatings for paper and
paperboard.
Carrageenan and salts of carrageenan as
described in Secs. 172.620 and
172.626 of this chapter.
Castor oil, hydrogenated...............
Castor oil, sulfated, ammonium,
potassium, or sodium salt.
Cellulose, regenerated.................
Chloracetamide......................... For use only as polymerization-
control agent.
Cobaltous acetate...................... For use only as polymerization
catalyst.
Cumene hydroperoxide................... Do.
Cyanoguanidine......................... For use only:
1. As a modifier for amino
resins.
2. As a fluidizing agent in
starch and protein coatings
for paper and paperboard.
n-Decyl alcohol........................ For use only with calcium
isostearate as a stabilizing
material for aqueous calcium
stearate dispersions intended
for use as components of
coatings for paper and
paperboard.
Dialdehyde guar gum.................... For use only as a wet-strength
agent employed prior to the
sheet-forming operation in the
manufacture of paper and
paperboard and used at a level
not to exceed 1% by weight of
the finished dry paper and
paperboard fibers.
Dialdehyde locust bean gum............. Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS For use as a sizing agent at a
Reg. No. 41319-54-4) manufactured by level not to exceed 0.2
the reaction of secondary amines percent by weight of the dry
derived from fatty acids of animal or fiber.
vegetable sources with phosgene.
Diallyldimethyl ammonium chloride For use only as a retention and/
polymer with acrylamide and potassium or drainage aid employed prior
acrylate, produced by copolymerizing to the sheet-forming
either (1) diallyldimethyl ammonium operations in the manufacture
chloride and acrylamide in a weight of paper and paperboard and
ratio of 50/50, with 4.4 percent of limited to use at a level not
the acrylamide subsequently hydrolyzed to exceed 0.05 percent by
to potassium acrylate or (2) weight of the finished paper
polymerized diallyldimethyl ammonium and paperboard.
chloride, acrylamide and potassium
acrylate (as acrylic acid) in a weight
ratio of 50/47.8/2.2, respectively, so
that the finished resin in a 1 percent
by weight aqueous solution (active
polymer) has a viscosity of more than
22 centipoises at 22 deg.C (72
deg.F) as determined by LVF series,
Brookfield Viscometer using No. 1
spindle at 60 RPM (or by other
equivalent method) (CAS Reg. No. 25136-
75-8).
Diallyldimethylammonium chloride with For use only as a drainage and/
acrylamide (CAS Reg. No. 26590-05-6). or retention aid employed
The copolymer is produced by prior to the sheet-forming
copolymerizing diallyldimethylammonium operation in the manufacture
chloride with acrylamide in a weight of paper and paperboard and
ratio of 50-50 so that the finished limited to use at a level not
resin in a 1 percent by weight aqueous to exceed 0.05 percent by
solution (active polymer) has a weight of the finished paper
viscosity of more than 22 centipoises and paperboard.
at 22 deg.C (71.6 deg.F), as
determined by LVF-series Brookfield
viscometer using a No. 1 spindle at 60
r.p.m. (or by other equivalent method).
[[Page 189]]
Diallyldiethylammonium chloride polymer
with acrylamide, and
diallyldimethylammonium chloride,
produced by copolymerizing acrylamide,
diallyldiethylammonium chloride, and
diallyldimethylammonium chloride,
respectively, in the following weight
ratios and having viscosities
determined at 22 deg.C, by LVF-series
Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other
equivalent method), as follows:.
1. Weight ratio: 50-2.5-47.5. The For use only as a retention aid
finished resin in a 1 percent by employed prior to the sheet-
weight aqueous solution has a forming operation in the
minimum viscosity of 22 centipoises. manufacture of paper and
paperboard and limited to use
at a level not to exceed 0.05
percent by weight of the
finished paper and paperboard.
2. Weight ratio: 25-2.5-72.5. The For use only as a drainage and/
finished resin in a 0.20 percent by or retention aid employed
weight aqueous solution has a prior to the sheet-forming
minimum viscosity of 20 centipoises. operation in the manufacture
of paper and paperboard and
limited to use at a level not
to exceed 0.075 percent by
weight of the finished paper
and paperboard.
3. Weight ratio: 80-2.5-17.5. The For use only as a drainage and/
finished resin in a 0.30 percent by or retention aid employed
weight aqueous solution has a prior to the sheet-forming
minimum viscosity of 50 centipoises. operation in the manufacture
of paper and paperboard and
limited to use at a level not
to exceed 0.075 percent by
weight of the finished paper
and paperboard.
Diallyldiethylammonium chloride polymer For use only as a retention aid
with acrylamide, potassium acrylate, employed prior to the sheet-
and diallyldimethylammonium chloride. forming operation in the
The polymer is produced by manufacture of paper and
copolymerizing either: (1) acrylamide, paperboard and limited to use
diallyldiethylammonium chloride, and at a level not to exceed 0.05
diallyldimethylammonium chloride in a percent by weight of the
weight ratio of 50-2.5-47.5, finished paper and paperboard.
respectively, with 4.4 percent of the
acrylamide subsequently hydrolyzed to
potassium acrylate, or (2) acrylamide,
potassium acrylate (as acrylic acid),
diallyldiethylammonium chloride, and
diallyldimethylammonium chloride in a
weight ratio of 47.8-2.2-2.5-47.5, so
that the finished resin in a 1 percent
by weight aqueous solution has a
minimum viscosity of 22 centipoises at
22 deg.C, as determined by LVF-series
Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other
equivalent method).
Diallyldimethylammonium chloride For use only as a dry and wet
polymer with acrylamide, reaction strength agent employed prior
product with glyoxal, produced by to the sheet-forming operation
copolymerizing not less than 90 weight in the manufacture of paper
percent of acrylamide and not more and paperboard in such an
than 10 weight percent of amount that the finished paper
diallyldimethylammonium chloride, and paperboard will contain
which is then cross-linked with not the additive at a level not in
more than 30 weight percent of excess of 2 percent by weight
glyoxal, such that a 10 percent of the dry fibers in the
aqueous solution has a minimum finished paper and paperboard.
viscosity of 25 centipoises at 25
deg.C as determined by Brookfield
viscometer Model RVF, using a No. 1
spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS For use as a preservative at a
Reg. No.10222-01-2).. level not to exceed 100 parts
per million in coating
formulations and in component
slurries and emulsions, used
in the production of paper and
paperboard and coatings for
paper and paperboard.
2,5-Di-tert-butyl hydroquinone......... For use only as an antioxidant
for fatty based coating
adjuvants provided it is used
at a level not to exceed
0.005% by weight of coating
solids.
Diethanolamine......................... For use only:
1. As an adjuvant to control
pulp absorbency and pitch
content in the manufacture of
paper and paperboard prior to
the sheet-forming operation.
2.In paper mill boilers.
Diethanolamine salts of mono- and bis For use only as an oil and
(1H,1H,2H,2H-perfluoroalkyl) water repellant at a level not
phosphates where the alkyl group is to exceed 0.17 pound (0.09
even-numbered in the range C8-C18 and pound of fluorine) per 1,000
the salts have a fluorine content of square feet of treated paper
52.4% to 54.4% as determined on a or paperboard, as determined
solids basis. by analysis for total fluorine
in the treated paper or
paperboard without correction
for any fluorine which might
be present in the untreated
paper or paperboard, when such
paper or paperboard is used in
contact with nonalcoholic
foods under the conditions of
use described in paragraph (c)
of this section, table 2,
conditions of use (B) through
(H).
[[Page 190]]
Diethyl(2-hydroxyethyl) methylammonium For use only as a retention aid
methyl sulfate, acrylate, polymer with and drainage aid employed
acrylamide, chemical abstract service prior to the sheet-forming
registry No. [26796-75-8] having 90-95 operation in the manufacture
mole pct. acrylamide, a nitrogen of paper and paperboard at a
content of not more than 19.7 pct. level not to exceed 0.15 pct.
(Kjeldahl, dry basis), and a residual by weight of finished dry
acrylamide monomer content of not more paper and paperboard fibers.
than 0.1 pct. The finished polymer in
a 1 pct. by weight aqueous solution
has a minimum viscosity of 900
centipoises at 25 deg.C as determined
by LVT-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or
by equivalent method).
Diethylenetriamine..................... For use only as a modifier for
amino resins.
N,N-Diisopropanolamide of tallow fatty For use only as an adjuvant to
acids. control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
Dimethylamine-epichlorohydrin copolymer For use only:
in which not more than 5 mole-percent 1. As a retention aid employed
of dimethylamine may be replaced by an before the sheet-forming
equimolar amount of ethylenediamine operation in the manufacture
and in which the ratio of total amine of paper and paperboard and
to epichlorohydrin does not exceed limited to use at a level not
1:1. The nitrogen content of the to exceed 1 percent by weight
copolymer shall be 9.4 to 10.8 weight of the finished paper and
percent on a dry basis and a 10 paperboard.
percent by weight aqueous solution of 2. At the size press at a level
the final product has a minimum not to exceed 0.017 percent by
viscosity of 5.0 centipoises at 25 weight of the finished paper
deg.C, as determined by LVT-series and paperboard.
Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other
equivalent method).
N-[(Dimethylamino)methyl]-acrylamide For use only as a dry-strength
polymer with acrylamide and styrene agent employed prior to the
having a nitrogen content of not more sheet-forming operation in the
than 16.9 percent and a residual manufacture of paper and
acrylamide monomer content of not more paperboard and used at a level
than 0.2 percent on a dry basis. not to exceed 1 percent by
weight of finished dry paper
or paperboard fibers.
N,N'-Dioleoylethylenediamine...........
Diphenylamine.......................... For use only as an antioxidant
for fatty based coating
adjuvants provided it is used
at a level not to exceed
0.005% by weight of coating
solids.
Dipropylene glycol.....................
Disodium salt of 1,4-dihydro-9,10- For use only as a catalyst in
dihydroxyanthracene (CAS Reg. No. the alkaline pulping of
73347-80-5). lignocellulosic materials at
levels not to exceed 0.1
percent by weight of the raw
lignocellulosic materials.
N,N'-Distearoylethylenediamine.........
n-Dodecylguanidine acetate............. For use only as an
antimicrobial agent in paper
and paperboard under the
following conditions:
1. For contact only with nonalcoholic
food having a pH above 5 and provided
it is used at a level not to exceed
0.4 percent by weight of the paper and
paperboard.
2. For use in the outer ply of
multiwall paper bags for contact with
dry food of Type VIII described in
table I of paragraph (c) of this
section and provided it is used at a
level of 0.8 percent by weight of the
paper.
n-Dodecylguanidine hydrochloride....... For use only as an
antimicrobial agent in paper
and paperboard under the
following conditions:
1. For contact only with
nonalcoholic food having a pH
above 5 and provided it is
used at a level not to exceed
0.4 percent by weight of the
paper and paperboard.
2. For use in the outer ply of
multiwall paper bags for
contact with dry food of Type
VIII described in table I of
paragraph (c) of this section
and provided it is used at a
level of 0.8 percent by weight
of the paper.
Fatty acids derived from animal and
vegetable fats and oils and salts of
such acids, single or mixed, as
follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferric chloride........................
Ferrous ammonium sulfate...............
Fish oil, hydrogenated.................
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as
described in Secs. 172.655 and
172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111-30-8). For use only as an
antimicrobial agent in pigment
and filler slurries used in
the manufacture of paper and
paperboard at levels not to
exceed 300 parts per million
by weight of the slurry
solids.
[[Page 191]]
Glyceryl lactostearate.................
Glyceryl mono-1,2-hydroxystearate......
Glyceryl monoricinoleate...............
Guar gum modified by treatment with For use only as a retention aid
-diethylamino- ethyl chloride and/or drainage aid employed
hydrochloride. prior to the sheet-forming
operation in the manufacture
of paper and paperboard.
Guar gum modified by treatment with not For use only as a retention aid
more than 25 weight percent of 2,3- and/or internal size employed
epoxypropyltri-methylammonium chloride prior to the sheet-forming
such that the finished product has a operation in the manufacture
maximum chlorine content of 4.5 of paper and paperboard, and
percent, a maximum nitrogen content of limited to use at a level: (1)
3.0 percent, and a minimum viscosity Not to exceed 0.15 percent by
in 1-percent-by-weight aqueous weight of the finished dry
solution of 1,000 centipoises at 77 paper and paperboard fibers
deg.F, as determined by RV-series intended for use in contact
Brookfield viscometer (or equivalent) with all types of foods,
using a No. 3 spindle at 20 r.p.m. except (2) not to exceed 0.30
pct. by weight of the finished
dried paper and paperboard
fibers for use with
nonalcoholic and nonfatty food
of types identified under
Types I, II, IV-B, VI-B, VII-
B, and VIII of table I in par.
(c) of this section.
N, N, N', N', N'', N''-Hexakis For use only as a water-
(methoxymethyl)-1,3,5-triazine-2,4,6- repellent applied to the
triamine polymer with stearyl alcohol, surface of paper and
-octadecenyl-omega- paperboard at levels not to
hydroxypoly(oxy-1,2-ethanediyl), and exceed 1 percent by weight of
alkyl (C20+) alcohols (CAS Reg. No. the finished dry paperboard
130328-24-4). fibers. The finished paper and
paperboard will be used in
contact with aqueous foods
under conditions of use B
through G as described in
table 2 of paragraph (c) of
this section.
Hexamethylenetetramine................. For use only as polymerization
cross-linking agent for
protein, including casein.
Hydroquinone and the monomethyl or For use only as an inhibitor
monoethyl ethers of hydroquinone. for monomers.
Hydroxymethyl-5,5-dimethylhydantoin For use only as a preservative
(CAS Reg. No. 27636-82-4), mixture in clay-type fillers at a
with 1,3-bis(hydroxymethyl)-5,5- level not to exceed a combined
dimethylhydantoin (CAS Reg. No. 6440- total of 1,200 milligrams/
58-0). kilograms hydroxymethyl-5,5-
dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-
dimethylhydantoin in the
filler.
Hydroxypropyl guar gum having a minimum For use only as a dry strength
viscosity of 5,000 centipoises at 25 and formation aid agent
deg.C., as determined by RV-series employed prior to the sheet-
Brookfield viscometer using a No. 4 forming operation in the
spindle at 20 r.p.m. (or other manufacture of paper and
suitable method) and using a test paperboard and used at a level
sample prepared by dissolving 5 grams not to exceed 1.5 percent by
of moisture-free hydroxypropyl guar weight of finished dry paper
gum in 495 milliliters of a 70 percent or paperboard fibers.
by weight aqueous propylene glycol
solution.
12-Hydroxystearic acid-polyethylene For use only as a surfactant
glycol block copolymers (CAS Reg. No. for dispersions of
70142-34-6) produced by the reaction polyacrylamide retention and
of polyethylene glycol (minimum drainage aids employed prior
molecular weight 200) with 12- to the sheet forming operation
hydroxystearic acid. in the manufacture of paper
and paperboard.
Imidazolium compounds, 2-(C17 and C17- For use only at a level 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)..
Isopropyl m- and p-cresols (thymol For use only as an antioxidant
derived). for fatty based coating
adjuvants provided it is used
as a level not to exceed
0.005% by weight of coating
solids.
Isopropyl peroxydicarbonate............ For use only as polymerization
catalyst.
Japan wax..............................
Lanolin................................
Lauryl peroxide........................ For use only as polymerization
catalyst.
Lauryl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lecithin, hydroxylated.................
Lignin sulfonate and its calcium,
potassium, and sodium salts.
Maleic anhydride, polymer with ethyl For use only as a deposit
acrylate and vinyl acetate, hydrolyzed control additive prior to the
(CAS Reg. No. 113221-69-5) and/or its sheet forming operation to
ammonium, potassium, and sodium salts. prevent scale buildup in the
manufacture of paper and
paperboard in contact with
food, at a level not to exceed
0.075 percent (as the acid) by
weight of the dry paper and
paperboard.
Methacrylic acid-acrylic acid copolymer For use only as a boiler water
(CAS Reg. No. 25751-21-7). additive at a level not to
exceed 50 parts per million in
the boiler water.
N-methyldiallylamine hydrochloride For use only as a retention
polymer with epichlorohydrin having a aid, flocculating agent, and
nitrogen content of 4.8 to 5.9 percent wet-strength agent employed in
(Kjeldahl dry basis) such that a 20 the manufacture of paper and
percent by weight aqueous solution has paperboard prior to the sheet-
a minimum viscosity of 30 centipoises forming operation and limited
and maximum viscosity of 100 to use at a level not to
centipoises at 25 deg.C, as exceed 1.5 percent by weight
determined by LVF Model Brookfield of the dry paper and
viscometer using a No. 1 spindle at 60 paperboard.
r.p.m. (or equivalent method).
[[Page 192]]
Methyl naphthalene sulfonic acid- For use only as an adjuvant to
formaldehyde condensate, sodium salt. control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
N-methyl-N-(tall oil acyl) taurine, For use only to control scale
sodium salt (CAS Reg. No. 61791-41-1). formation in the manufacture
of paper and paperboard prior
to the sheetforming operation
at a level not to exceed 0.015
percent by weight of the dry
paper and paperboard.
Mineral oil, white.....................
Mono-, di-, tri-(1-methyl-1- For use only as an emulsifier
phenylethyl)-phenol, ethoxylated, for rosin based sizing at a
sulfated, ammonium salt with an level not to exceed 0.03
average of 12 to 16 moles of ethylene percent by weight of the
oxide (CAS Reg. No. 68130-71-2). finished dry paper and
paperboard.
Monoglyceride citrate..................
Monoisopropanolamine (CAS Reg. No. 78- For use as a dispersant for
96-6). titanium dioxide suspensions
at a level not to exceed 0.68
percent by weight of titanium
dioxide. The finished paper
and paperboard will be used in
contact with all food types
under conditions of use E
through G described in table 2
of paragraph (c) of this
section.
Mustardseed oil, sulfated, ammonium,
potassium, or sodium salt.
Naphthalene sulfonic acid-formaldehyde For use only as an adjuvant to
condensate, sodium salt. control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
Nitrocellulose, 10.9-12.2% nitrogen....
Oleic acid, sulfated, ammonium,
potassium, or sodium salt.
N-Oleoyl-N'-stearoylethylenediamine....
Oxystearin.............................
Paraformaldehyde....................... For use only as setting agent
for protein.
Pentanoic acid, 4,4-bis [(gamma-omega- For use only as an oil and
perfluoro-C8-20-alkyl)thio] water repellent and used at a
derivatives, compounds with level not to exceed 8 pounds
diethanolamine (CAS Reg. No. 71608-61- per ton of the finished paper
2). or paperboard when such paper
or paperboard is used in
contact with nonalcoholic
foods under conditions of use
E through H described in table
2 of paragraph (c) of this
section.
Perfluoroalkyl acrylate copolymer (CAS For use only as an oil and
Reg. No. 92265-81-1) containing 35 to water repellent at a level not
40 weight percent fluorine, produced to exceed 0.5 percent by
by the copolymerization of weight of the finished paper
ethanaminium, N,N,N-trimethyl-2-[(2- and paperboard in contact with
methyl-1-oxo-2-propenyl)-oxy]-, nonalcoholic foods under
chloride; 2-propenoic acid, 2-methyl-, conditions of use C, D, E, F,
oxiranylmethyl ester; 2-propenoic G, or H described in table 2
acid, 2-ethoxyethyl ester; and 2- of paragraph (c) of this
propenoic acid, 2[[(heptadecafluoro- section.
octyl)sulfonyl] methyl amino]ethyl
ester.
Perfluoroalkyl substituted phosphate For use only as an oil and
ester acids, ammonium salts formed by water repellant at a level not
the reaction of 2,2-bis[ (,-perfluoroC4-20 perfluoroalkyl actives by
alkylthio) methyl]-1,3-propanediol, weight of the finished paper
polyphosphoric acid and ammonium and paperboard in contact with
hydroxide. non-alcoholic foods under
condition of use H as
described in table 2 of
paragraph (c) of this section;
and in contact with food of
types III, IV-A, V, VII-A, and
IX described in table 1 of
paragraph (c) of this section
under conditions of use C
through G as described in
table 2 of paragraph (c) of
this section..
Petrolatum............................. Complying with Sec. 178.3700
of this chapter.
Petroleum asphalt, steam and vacuum For use only as a component of
refined to meet the following internal sizing of paper and
specifications: Softening point 88 paperboard intended for use in
deg. C to 93 deg. C, as determined by contact only with raw fruits,
ASTM method D36-76, ``Standard Test raw vegetables, and dry food
Method for Softening Point of Bitumen of the type identified under
(Ring-and-Ball Apparatus);'' Type VIII of table 1 in
penetration at 25 deg. C not to exceed paragraph (c) of this section,
0.3 mm, as determined by ASTM method and provided that the asphalt
D5-73 (Reapproved 1978), ``Standard is used at a level not to
Test Method for Penetration of exceed 5% by weight of the
Bituminous Materials,'' which are finished dry paper and
incorporated by reference (copies may paperboard fibers.
be obtained from the American Society
for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408);
and maximum weight loss not to exceed
3% when distilled to 371 deg. C, nor
to exceed an additional 1.1% when
further distilled between 371 deg. C
and thermal decomposition.
Petroleum wax, synthetic............... Complying with Sec. 178.3720
of this chapter.
Phenothiazine.......................... For use only as antioxidant in
dry rosin size.
Phenyl acid phosphate.................. For use only as polymerization
catalyst in melamine-
formaldehyde modified alkyd
coatings and limited to use at
a level not to exceed 2% by
weight of the coating solids.
Phenyl--naphthylamine......... For use only as antioxidant in
dry rosin size and limited to
use at a level not to exceed
0.4% by weight of the dry
rosin size.
[[Page 193]]
Phosphoric acid esters and polyesters For use as an adjuvant prior to
(and their sodium salts) of the sheet forming operation to
triethanolamine formed by the reaction control pitch and scale
of triethanolamine with polyphosphoric formation in the manufacture
acid to produce a mixture of esters of paper and paperboard
having an average nitrogen content of intended for use in contact
1.5 percent and an average phosphorus with food only of the types
content of 32 percent (as PO4). identified in paragraph (c) of
this section, table 1, under
Types I, IV, V, VII, VIII, and
IX, and used at a level not to
exceed 0.075 percent by weight
of dry paper or paperboard
fibers.
Poly[acrylamide-acrylic acid-N- For use only as a drainage aid
(dimethyl-aminomethyl)acryl- amide], and retention aid employed
produced by reacting 2.40 to 3.12 prior to the sheet-forming
parts by weight of polyacrylamide with operation in the manufacture
1.55 parts dimethylamine and 1 part of paper and paperboard for
formaldehyde, and containing no more use in contact with fatty
than 0.2 percent monomer as acrylamide. foods under conditions of use
described in paragraph (c) of
this section, table 2,
conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2- For use only as a retention and
hydroxypropyl acrylate) produced when drainage aid employed prior to
one mole of hydroxypropyl acrylate and the sheet-forming operation in
three moles of acrylic acid are the manufacture of paper and
reacted with three moles of paperboard at a level not to
ethylenimine and three moles of nitric exceed 0.2 percent by weight
acid, such that a 35 percent by weight of dry paper or paperboard
aqueous solution has a minimum fiber.
viscosity of 150 centipoises at 72
deg.F., as determined by RVF-series
Brookfield viscometer (or equivalent)
using a No. 2 spindle at 20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite For use only as an agent in
(0.7 part) adduct, containing excess modifying starches and starch
bisulfite (ratio of excess bisulfite gums used in the production of
to adduct not to exceed 1.5 to 1). paper and paperboard and
limited to use at a level not
to exceed 0.09 mg/in 2 of the
finished paper and paperboard.
Poly[acrylamide-acrylic acid-N- For use only as a drainage aid,
(dimethylaminomethyl) acrylamide] retention aid, or dry-strength
(C.A. Registry No. 53800-41-2), agent employed prior to the
produced by reacting 9.6-16.4 parts by sheet-forming operation in the
weight of polyacrylamide with 1.6 manufacture of paper and
parts dimethylamine and 1 part paperboard at a level not to
formaldehyde, and containing no more exceed 0.25 percent by weight
than 0.2% monomer as acrylamide, such of finished dry paper and
that a 20% aqueous solution has a paperboard fibers, when such
minimum viscosity of 4,000 cP at 25 paper or paperboard is used in
deg.C., as determined by Brookfield contact with fatty foods under
viscometer model RVT, using a No. 5 conditions of use described in
spindle at 20 r/min (or equivalent paragraph (c) of this section,
method). table 2, conditions of use E,
F, and G.
Polyamide-epichlorohydrin modified For use only as a retention aid
resin produced by reacting adipic acid and flocculant employed prior
with diethylene triamine to produce a to the sheet-forming operation
basic polyamide which is modified by in the manufacture of paper
reaction with formic acid and and paperboard and used at a
formaldehyde and further reacted with level not to exceed 0.2
epichlorohydrin in the presence of percent dry resin by weight of
ammonium hydroxide to form a water- finished dry paper or
soluble cationic resin having a paperboard fibers.
nitrogen content of 13-16 percent
(Kjeldahl, dry basis) such that a 35
percent by weight aqueous solution has
a minimum viscosity of 75 centipoises
at 25 deg.C, as determined by
Brookfield viscometer using a No. 1
spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble For use only under the
thermosetting resins [CAS Reg. No. following conditions:
68583-79-9] prepared by reacting 1. As a retention aid employed
adipic acid with diethylenetriamine to prior to the sheet-forming
form a basic polyamide and further operation in the manufacture
reacting the polyamide with an of paper and paperboard and
epichlorohydrin and dimethylamine limited to use at a level not
mixture such that the finished resins to exceed 0.12 percent by
have a nitrogen content of 17.0 to weight of dry paper or
18.0 percent of a dry basis, and that paperboard.
a 30-percent-by-weight aqueous 2. The finished paper or
solution has a minimum viscosity of paperboard will be used in
350 centipoises at 20 deg.C, as contact with food only of the
determined by a Brookfield viscometer types identified in paragraph
using a No. 3 spindle at 30 r.p.m. (or (c) of this section, table 1,
equivalent method). under types I and IV-B and
under conditions of use
described in paragraph (c) of
this section, table 2,
conditions of use F and G.
Polyamide-epichlorohydrin water-soluble For use only as a wet strength
thermosetting resin (CAS Reg. No. agent and/or retention aid
96387-48-3) prepared by reacting N- employed prior to the sheet-
methyl-bis(3-aminopropyl) amine with forming operation in the
oxalic acid and urea to form a basic manufacture of paper and
polyamide and further reacting the paperboard and used at a level
polyamide with epichlorohydrin. not to exceed 1.5 percent by
weight of dry paper and
paperboard fibers.
Polyamide-epichlorohydrin water-soluble For use only in the manufacture
thermosetting resins prepared by of paper and paperboard under
reacting adipic acid, isophthalic conditions such that the
acid, itaconic acid or dimethyl resins do not exceed 1.5
glutarate with diethylenetriamine to percent by weight of the paper
form a basic polyamide and further or paperboard.
reacting the polyamide with one of the
following:
Epichlorohydrin.
Epichlorohydrin and ammonia mixture.
Epichlorohydrin and sodium
hydrosulfite mixture.
Polyamidoamine-ethyleneimine- For use only as a retention aid
epichlorohydrin resin prepared by employed prior to the sheet-
reacting hexanedioic acid, N-(2- forming operation in the
aminoethyl)-1,2-ethanediamine, manufacture of paper and
(chloromethyl)oxirane, ethyleneimine paperboard at a level not to
(aziridine), and polyethylene glycol, exceed 0.12 percent resin by
partly neutralized with sulfuric acid weight of the finished dry
(CAS Reg. No. 167678-45-7). paper or paperboard.
[[Page 194]]
Polyamidol-epichlorohydrin modified For use only as a wet strength
resin produced by reacting glutaric agent employed prior to the
acid dimethyl ester with diethylene- sheet-forming operation in the
triamine to produce a basic polyamide manufacture of paper and
which is modified by reaction with paperboard, and used at a
formaldehyde and further reacted with level not to exceed 2.5
epicholorohydrin to form a water percent by weight of dry paper
soluble cationic resin having a and paperboard fibers when
nitrogen content of 10.9-11.9 percent such paper or paperboard is
and a chlorine content of 13.8-14.8 used in contact with food
percent, on a dry basis, and a minimum under conditions of use E
viscosity, in 12.5 percent by weight through G described in table 2
aqueous solution, of 10 centipoises at of paragraph (c) of this
25 deg. C, as determined by a section.
Brookfield Model LVF viscometer using
a No. 1 spindle at 60 r.p.m. (or
equivalent method).
Polyamine-epichlorohydrin resin For use only as a flocculant,
produced by the reaction of drainage aid, formation aid,
epichlorohydrin with monomethylamine retention aid, or strength
to form a prepolymer and further additive employed prior to the
reaction of this prepolymer with sheet-forming operation in the
N,N,N',N'-tetramethylethylenediamine manufacture of paper and
such that the finished resin having a paperboard, and used at a
nitrogen content of 11.6 to 14.8 level not to exceed 0.12
percent and a chlorine content of 20.8 percent by weight of dry paper
to 26.4 percent and a minimum and paperboard fibers.
viscosity, in 25 percent by weight
aqueous solution, of 500 centipoises
at 25 deg. C, as determined by LV-
series Brookfield viscometer using a
No. 2 spindle at 12 r.p.m. (or by
other equivalent method).
Polyamine-epichlorohydrin resin For use only as a clarifier in
produced by the reaction of N,N- the treatment of influent
dimethyl-1,3-propanediamine with water to be used in the
epichlorohydrin and further reacted manufacture of paper and
with sulfuric acid, Chemical Abstracts paperboard, and used at a
Service Registry Number [27029-41-0], level not to exceed 20 parts
such that the finished resin has a per million of the influent
maximum nitrogen content of 14.4 water.
percent (dry basis) and a minimum
viscosity in 30 percent by weight
aqueous solution (pH 4-6) of 50
centipoises at 25 deg.C, as
determined by Brookfield LVT model
viscometer, using a No. 1 spindle at
12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble For use only as a wetstrength
thermosetting resin produced by agent and/or retention aid
reacting epichlorohydrin with: (i) employed prior to the sheet-
polyamines comprising at least 95 forming operation in the
percent by weight C4 to C6 aliphatic manufacture of paper and
diamines and/or their self- paperboard, and used at a
condensation products, and/or (ii) level not to exceed 1 percent
prepolymers produced by reacting 1,2- by weight of dry paper and
dichloroethane with the polyamines in paperboard fibers.
(i). The finished resin has a nitrogen
content of 5.0 to 9.0 percent, a
chlorine content of 18.0 to 35.0
percent on a dry basis, and a minimum
viscosity, in a 25 percent by weight
aqueous solution, of 50 centipoises at
20 deg.C (68 deg.F), as determined
by Brookfield HAT model viscometer
using a No. 1H spindle at 50 r.p.m.
(or equivlent method).
Polyamine-epichlorohydrin water-soluble For use only as a wet-strength
thermosetting resin produced by agent and/or retention aid
reacting epichlorohydrin with: (i) employed prior to the sheet-
polyamines comprising at least 95 forming operation in the
percent by weight C4 to C6 aliphatic manufacture of paper and
diamines and/or their seIf- paperboard, and used at a
condensation products and/or (ii) level not to exceed 1 percent
hexamethylenediamine, and/or (iii) by weight of dry paper and
bis(hexamethylene) triamine and higher paperboard fibers.
homologues, and/or (iv) prepolymers
produced by reacting 1,2-
dichloroethane with the polyamines in
(i) and/or (ii) and/or (iii). The
finished resin has a nitrogen content
of 5.0 to 9.0 percent, a chlorine
content of 18.0 to 35.0 percent on a
dry basis, and a minimum viscosity, in
a 25 percent by weight aqueous
solution, of 50 centipoises at 20
deg.C (68 deg.F), as determined by
Brookfield HAT model viscometer using
a No. 1H spindle at 50 r.p.m. (or
equivalent method).
Polyamine-epichlorohydrin water soluble For use only as a wet-strength
thermosetting resin prepared by agent and/or retention aid
reacting hexamethylenediamine with 1,2- employed prior to the sheet-
dichloroethane to form a prepolymer forming operation in the
and further reacting this prepolymer manufacture of paper and
with epichlorohydrin. This resin is paperboard, and used at a
then reacted with nitrilotris level not to exceed 1 percent
(methylene-phosphonic acid), by weight of dry paper and
pentasodium salt, such that the paperboard fibers.
finished resin has a nitrogen content
of 5.0-5.3 percent; a chlorine content
of 29.7-31.3 percent; and a phosphorus
content of 2.0-2.2 percent, on a dry
basis, and a minimum viscosity, in 25
percent by weight aqueous solution, of
50 centipoises at 25 deg.C., as
determined on a Brookfield HAT model
viscometer using a No. 1H spindle at
50 r.p.m. (or equivalent method).
[[Page 195]]
Polyamine resin produced by the For use only as a retention aid
reaction of 1,2-dichloroethane with and/or flocculent employed
bis(hexamethylene)triamine and higher prior to the sheet-forming
homologues such that the finished operation in the manufacture
resin has a nitrogen content of 13.0- of paper and paperboard and
15.0 percent on a dry basis, and a used at a level not to exceed
minimum viscosity in 25-percent-by- 0.1 percent by weight of dry
weight aqueous solution of 75 paper or paperboard fibers.
centipoises at 25 deg.C., as
determined by Brookfield HAT model
viscometer using a No. 1 spindle at 50
r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified For use only as a wet-strength
resin produced by reacting adipic acid agent and/or retention aid
with diethylenetriamine to produce a employed prior to the sheet-
polyamide which is modified by forming operation in the
reaction with diethylaminopropylamine manufacture of paper and
and further reacted with dichloroethyl paperboard, and used at a
ether to form a polyamide level not to exceed 0.5
intermediate. This polyamide percent by weight of the
intermediate is then reacted with finished dry paper and
epichlorohydrin such that the finished paperboard.
resins have a nitrogen content of 10.9-
12.4 percent (Kjeldahl, dry basis) and
a minimum viscosity in 40 percent-by-
weight aqueous solution of 250
centipoises at 22 deg.C, as
determined by a Brookfield Model LVT
viscometer using a No. 2 spindle at 30
r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying For use only as provided in
with the identity prescribed under Secs. 175.300, 178.3740 and
Sec. 178.3740(b) of this chapter. 178.3860 of this chapter.
Poly(diallyldimethylammonium chloride) For use only:
(CAS Reg. No. 26062-79-3) produced by 1. As a pigment dispersant and/
the polymerization of or retention aid prior to the
(diallyldimethylammonium chloride) so sheet-forming operation in the
that the finished resin has a nitrogen manufacture of paper and
content of 8.66plus-minus0.4 percent paperboard, and used at a
on a dry weight basis and a minimum level not to exceed 10 pounds
viscosity in a 40 percent by weight of active polymer per ton of
aqueous solution of 1,000 centipoises finished paper and paperboard.
at 25 deg.C (77 deg.F), determined 2. As a pigment dispersant in
by LVF Model Brookfield Viscometer coatings at a level not to
using a No. 3 spindle at 30 r.p.m. (or exceed 3.5 pounds of active
equivalent method). The level of polymer per ton of finished
residual monomer is not to exceed 1 paper and paperboard.
percent by weight of the polymer (dry
basis).
Poly (diallyldimethylammonium chloride) For use only as a flocculant
(CAS Reg. No. 26062-79-3) produced by employed prior to the sheet-
the polymerization of forming operation in the
diallyldimethylammonium chloride so manufacture of paper and
that the finished resin has a nitrogen paperboard, and used at a
content of 8.66plus-minus0.4 percent level not to exceed 10 mg/L
on a dry basis and a minimum viscosity (10 parts per million) of
in a 15 weight-percent aqueous influent water.
solution of 10 centipoises at 25
deg.C (77 deg.F), as determined by
LVF Model Brookfield viscometer using
a No. 1 spindle at 60 r/min (or
equivalent method). The level of
residual monomer is not to exceed 1
weight-percent of the polymer (dry
basis).
Poly(1,2-dimethyl-5-vinylpyridinium For use only as an adjuvant
methyl sulfate) having a nitrogen employed in the manufacture of
content of 5.7 to 7.3 percent and a paper and paperboard prior to
sulfur content of 11.7 to 13.3 percent the sheet-forming operation.
by weight on a dry basis and having a
minimum viscosity in 30-percent-by-
weight aqueous solution of 2,000
centipoises at 25 deg.C., as
determined by LV-series Brookfield
viscometer (or equivalent) using a No.
4 spindle at 60 r.p.m.
Polyester resin produced by reacting For use only as a surface-
dimethylolpropionic acid (CAS Registry sizing compound applied after
No. 4767-03-7) as a comonomer, at no the sheet-forming operation in
more than 30 percent by weight of the manufacture of paper and
total polymer solids in reaction with paperboard and limited to use
2,2-dimethyl-1,3-propanediol, phthalic at levels not to exceed 0.1
anhydride and isophthalic acid, such percent by weight of finished
that the polyester resin has a dry paper or paperboard.
viscosity of 200-600 centipoises at 80
deg.F as determined by a Brookfield
RVT viscometer using a number 3
spindle at 50 rpm (or equivalent
method).
Polyethylene, oxidized; complying with For use only as component of
the identity prescribed in Sec. coatings that contact food
177.1620(a) of this chapter. only of the type identified
under Type VII-B of table 1 in
paragraph (c) of this section,
and limited to use at a level
not to exceed 50 percent by
weight of the coating solids.
Polyethyleneamine mixture produced when For use only as a retention aid
1 mole of ethylene dichloride, 1.05 employed prior to the sheet-
moles of ammonia, and 2 moles of forming operation in the
sodium hydroxide are made to react so manufacture of paper and
that a 10 percent aqueous solution has paperboard.
a minimum viscosity of 40 centipoises
at 77 deg.F, as determined by
Brookfield viscometer using a No. 1
spindle at 60 r.p.m.
Polyethylene glycol (200) dilaurate.... For use only as an adjuvant
employed in the manufacture of
paper and paperboard prior to
the sheet-forming operation.
Polyethylene glycol (400) dioleate.....
Polyethylene glycol (400) esters of
coconut oil fatty acids.
Polyethylene glycol (600) esters of
tall oil fatty acids.
Polyethylene glycol (400) monolaurate..
Polyethylene glycol (600) monolaurate..
Polyethylene glycol (400) monooleate...
Polyethylene glycol (600) monooleate...
Polyethylene glycol (400) monostearate.
[[Page 196]]
Polyethylene glycol (600) monostearate.
Polyethylene glycol (3,000)
monostearate.
Polyethylenimine, produced by the For use only as an adjuvant
polymerization of ethylenimine. employed prior to sheet
formation in paper-making
systems operated at a pH of
4.5 or higher, and limited to
use at a level not to exceed
5% by weight of finished dry
paper or paperboard fibers.
Poly(isobutene)/maleic anhydride For use only as a surfactant
adduct, diethanolamine reaction for dispersions of
product. The mole ratio of polyacrylamide retention and
poly(isobutene)/maleic anydride adduct drainage aids employed prior
to diethanolamine is 1:1. to the sheet formation
operation in the manufacture
of paper and paperboard.
Polymethacrylic acid, sodium salt, For use only as a coating
having a viscosity in 30-percent-by- adjuvant for controlling
weight aqueous solution of 125-325 viscosity when used at a level
centipoises at 25 deg.C as determined not to exceed 0.3% by weight
by LV-series Brookfield viscometer (or of coating solids.
equivalent) using a No. 2 spindle at
60 r.p.m.
Polymethacrylic acid, sodium salt, For use only as a coating
having a viscosity in 40-percent-by- adjuvant for controlling
weight aqueous solution of 400-700 viscosity when used at a level
centipoises at 25 deg.C, as not to exceed 0.1% by weight
determined by LV-series Brookfield of coating solids.
viscometer (or equivalent) using a No.
2 spindle at 30 r.p.m.
Poly[(methylimino)(2- For use only as a retention aid
hydroxytrimethylene)hydrochloride] employed prior to the sheet-
produced by reaction of 1:1 molar forming operation in such an
ratio of methylamine and amount that finished paper and
epichlorohydrin so that a 31-percent paperboard will contain the
aqueous solution at 25 deg. C has a additive at a level not in
Stokes viscosity range of 2.5-4.0 as excess of 1 percent by weight
determined by ASTM method D1545-76 of the dry paper and
(Reapproved; 1981), ``Standard Test paperboard.
Method for Viscosity of Transparent
Liquids by Bubble Time Method,'' which
is incorporated by reference. Copies
may be obtained from the American
Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or
may be examined at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408.
Poly[oxyethylene (dimethyliminio) For use only to improve dry-
ethylene (dimethyliminio) ethylene strength of paper and
dichloride] produced by reacting paperboard and as a retention
equimolar quantities of N,N,N,N- and drainage aid employed
tetramethylethylene-diamine and prior to the sheet-forming
dichlorethyl ether to yield a solution operation in the manufacture
of the solid polymer in distilled of paper and paperboard and
water at 25 deg. C with a reduced limited to use at a level not
viscosity of not less than 0.15 to exceed 0.1 percent by
deciliter per gram as determined by weight of the finished dry
ASTM method D1243-79, ``Standard Test paper and paperboard fibers.
Method for -Dilute Solution Viscosity
of Vinyl Chloride Polymers,'' which is
incorporated by reference. Copies may
be obtained from the American Society
for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408).
The following formula is used for
determining reduced viscosity:.
Reduced viscosity in terms of
deciliters per gram=(t-t0)/(t-C),
where:
t=Solution efflux time
to=Water efflux time
C=Concentration of solution in terms
of grams per deciliter
Polypropylene glycol (minimum molecular
weight 1,000).
Potassium persulfate...................
2-Propenoic acid, telomer with sodium 2- For use only as a deposit
methyl-2-[(1-oxo-2-propenyl)amino]-1- control additive employed
propane sulfonate and sodium prior to the sheet forming
phosphinate (CAS Reg. No. 110224-99-2). operation in the manufacture
of paper and paperboard and at
a level not to exceed 0.15
percent by weight of the dry
paper and paperboard.
Propylene glycol alginate..............
Protein hydrolysate from animal hides
or soybean protein condensed with
oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium,
potassium, or sodium salt.
Ricebran oil, sulfated ammonium,
potassium, or sodium salt.
Rosin and rosin derivatives............ As provided in Sec. 178.3870
of this chapter.
Siloxanes (silicones), dimethyl, For use only as a component of
isopropyl methyl, methyl 1-methyl-C9- polyolefin coatings with Sec.
49-alkyl (CAS Reg. No. 144635-08-5). 177.1520 of this chapter at a
level not to exceed 3 percent
by weight. The finished
coating will be used only for
paper and paperboard that
contact food of types VI-A and
VI-B of table 1 in paragraph
(c) of this section, and under
conditions of use C, D, and E,
as described in table 2 in
paragraph (c) of this section,
with a maximum hot fill
temperature of 200 deg.F (94
deg.C).
Silver chloride-coated titanium dioxide For use only as a preservative
in polymer latex emulsions at
a level not to exceed 2.2
parts per million (based on
silver ion concentration) in
the dry coating.
[[Page 197]]
Sodium carboxymethyl guar gum having a For use only as a dry-strength
minimum viscosity of 2,700 centipoises and formation-aid agent
at 25 deg.C after 24 hours as employed prior to the sheet-
determined by RV-series Brookfield forming operation in the
viscometer (or equivalent) using a No. manufacture of paper and
4 spindle at 20 r.p.m. and using a paperboard and used at a level
test sample prepared by dissolving 8 not to exceed 1% by weight of
grams of sodium carboxymethyl guar gum finished dry paper or
in 392 milliliters of 0.2-percent-by- paperboard fibers.
weight aqueous sodium o-phenylphenate
solution.
Sodium dioctyl sulfosuccinate..........
Sodium formaldehyde sulfoxylate........ For use only as polymerization
catalyst.
Sodium hypochlorite....................
Sodium N-methyl-N-oleyltaurate......... For use only as an adjuvant to
control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
Sodium nitrite......................... For use only:
1. At levels not to exceed 0.2%
by weight of lubricants or
release agents applied at
levels not to exceed 1 lb. per
ton of finished paper or
paperboard.
2. As an anticorrosion agent at
levels not to exceed 0.2% by
weight of wax emulsions used
as internal sizing in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
Sodium persulfate......................
Sodium polyacrylate.................... For use only:
1. As a thickening agent for
natural rubber latex coatings,
provided it is used at a level
not to exceed 2 percent by
weight of coating solids.
2. As a pigment dispersant in
coatings at a level not to
exceed 0.25 percent by weight
of pigment.
Sodium poly(isopropenylphosphonate) For use only in paper mill
(CAS Reg. No. 118632-18-1). boilers.
Sodium zinc potassium polyphosphate For use only as a pigment
(CAS Reg. No. 65997-17-3). dispersant in coatings at a
level not to exceed 1 percent
by weight of pigment.
Sperm oil, sulfated, ammonium,
potassium, or sodium salt.
Stannous oleate........................
Stearyl-2-lactylic acid and its calcium
salt.
Styrene-butadiene copolymers produced
by copolymerizing styrene-butadiene
with one or more of the monomers:
acrylamide, acrylic acid, fumaric
acid, 2-hydroxyethyl acrylate,
itaconic acid, methacrylic acid, and N-
methylolacrylamide (CAS Reg. No. 53504-
31-7). The finished copolymers shall
contain not more than 10 weight
percent of total polymer units derived
from acrylic acid, fumaric acid, 2-
hydroxyethyl acrylate, itaconic acid,
and methacrylic acid, and shall
contain not more than 3 weight percent
of total polymer units derived from N-
methylolacrylamide, and shall contain
not more than 2 weight percent of
polymer units derived from acrylamide..
Styrene-maleic anhydride copolymer, For use only as a surface size
amidated, ammonium sodium salt; at a level not to exceed 1
having, in a 25 percent by weight percent by weight of paper or
aqueous solution at pH 8.8, a minimum paperboard substrate.
viscosity of 600 centipoises at 25
deg.C as determined by Brookfield
model LVT viscometer using a No. 3
spindle at 60 r.p.m. (or equivalent
method).
Styrene-maleic anhydride copolymer, For use only:
sodium salt (minimum molecular weight 1. As a coating thickening
30,000). agent at a level not to exceed
1% by weight of coating
solids.
2. As surface size at a level
not to exceed 1% by weight of
paper or paperboard substrate.
Styrene-methacrylic acid copolymer, For use only as a coating
potassium salt (minimum molecular thickening agent at a level
weight 30,000). not to exceed 1% by weight of
coating solids.
Synthetic wax polymer prepared by the For use only as a component of
catalytic polymerization of alpha petroleum wax and/or synthetic
olefins such that the polymer has a petroleum wax complying with
maximum iodine number of 18 and a Sec. 178.3710 or Sec.
minimum number average molecular 178.3720 of this chapter at
weight of 2,400. levels not to exceed 5 percent
by weight of the wax:
1. Under conditions of use F
and G described in table 2 of
paragraph (c) of this section
for all foods.
2. Under conditions of use E
described in table 2 of
paragraph (c) of this section
for food Types I, II, IV-B,
VI, VII-B and VIII as
described in table 1 of
paragraph (c) of this section.
Tallow.................................
Tallow alcohol.........................
Tallow alcohol, hydrogenated...........
Tallow fatty acid, hydrogenated........
Tallow hydrogenated....................
Tallow sulfated, ammonium, potassium,
or sodium salt.
[[Page 198]]
Tetraethylenepentamine................. For use only as a modifier for
amino resins.
1,4,4a,9a-Tetrahydro-9, 10- For use only as a catalyst in
anthracenedione (CAS Reg. No. 56136-14- the alkaline pulping of
2). lignocellulosic materials at
levels not to exceed 0.1
percent by weight of the raw
lignocellulosic materials.
N,N,N', N'-Tetramethylethylenediamine For use only as a flocculent,
polymer with bis-(2-chloroethyl) drainage aid or retention aid
ether, first reacted with not more employed prior to the sheet
than 5 percent by weight 1-chloro-2,3- forming operation in the
epoxypropane and then reacted with not manufacture of paper and
more than 5 percent by weight poly paperboard and limited to use
(acrylic acid) such that a 50 percent at a level not to exceed 0.2
by weight aqueous solution of the percent by weight of the
product has a nitrogen content of 4.7- finished dry paper and
4.9 percent and viscosity of 350-700 paperboard fibers.
centipoises at 25 deg.C as determined
by LV series Brookfield viscometer
using a No. 2 spindle at 60 r.p.m. (or
by other equivalent method).
Tetrasodium N- (1,2-dicarboxyethyl) - N For use only as an emulsifier
- octadecylsulfo-succinamate. in aqueous dispersions of
rosin sizes complying with
Sec. 178.3870(a)(4) of this
chapter and limited to use
prior to the sheet-forming
operation in the manufacture
of paper and paperboard at a
level not to exceed 0.02 pct
by weight of finished paper
and paperboard.
Triethanolamine........................ For use only to adjust pH
during the manufacture of
amino resins permitted for use
as components of paper and
paperboard.
Triethylene glycol adipic acid For use only as a curl-control
monoester produced by reacting agent at a level not to exceed
equimolar quantities of triethylene 2% by weight of coated or
glycol and adipic acid. uncoated paper and paperboard.
Triethylenetetramine................... For use only as a modifier for
amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine For use only as an
(CAS Registry No. 7779-27-3). antimicrobial agent for
coating, binder, pigment,
filler, sizing, and similar
formulations added prior to
the heat drying step in the
manufacture of paper and
paperboard and limited to use
at a level between 0.05 and
0.15 percent by weight of the
formulation.
Undecafluorocyclohexanemethanol ester For use only as an oil
mixture of dihydrogen phosphate, repellent at a level not to
compound with 2,2' iminodiethanol exceed 0.087 lb (0.046 lb of
(1:1); hydrogen phosphate, compound fluorine) per 1,000 ft 2 of
with 2,2'-iminodiethanol (1:1); and treated paper or paperboard,
P,P'-dihydrogen pyrophosphate, as determined by analysis for
compound with 2,2'-iminodiethanol total fluorine in the treated
(1:2); where the ester mixture has a paper or paperboard without
fluorine content of 48.3 pct to 53.1 correction for any fluorine
pct as determined on a solids basis. which might be present in the
untreated paper or paperboard,
when such paper or paperboard
is used in contact with food
only of the types identified
in paragraph (c) of this
section, table 1, under Types
IVA, V, VIIA, VIII, and IX,
and under the conditions of
use B through G described in
table 2 of paragraph (c) of
this section.
Viscose rayon fibers...................
Wax, petroleum......................... Complying with Sec. 178.3710
of this chapter.
Xanthan gum, conforming to the identity For use only at a maximum level
and specifications prescribed in Sec. of 0.125 percent by weight of
172.695 of this chapter, except that finished paper as a suspension
the residual isopropyl alcohol shall aid or stabilizer for aqueous
not exceed 6,000 parts per million. pigment slurries employed in
the manufacture of paper and
paperboard.
Xylene sulfonic acid-formaldehyde For use only as an adjuvant to
condensate, sodium salt. control pulp absorbency and
pitch content in the
manufacture of paper and
paperboard prior to the sheet-
forming operation.
Zeolite Na-A (CAS Reg. No. 68989-22-0). For use as a pigment extender
at levels not to exceed 5.4
percent by weight of the
finished paper and paperboard.
Zinc formaldehyde sulfoxylate.......... For use only as polymerization
catalyst.
Zinc octoate...........................
Zirconium oxide........................ For use only as a component of
waterproof coatings where the
zirconium oxide is present at
a level not to exceed 1
percent by weight of the dry
paper or paperboard fiber and
where the zirconium oxide is
produced by hydrolysis of
zirconium acetate.
------------------------------------------------------------------------
(b) Substances identified in paragraphs (b) (1) and (2) of this
section may be used as components of the food-contact surface of paper
and paperboard, provided that the food-contact surface of the paper or
paperboard complies with the extractives limitations prescribed in
paragraph (c) of this section.
(1) Substances identified in Sec. 175.300(b)(3) of this chapter with
the exception of those identified in paragraphs (b)(3) (v), (xv), (xx),
(xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of this
section.
(2) Substances identified in this paragraph (b)(2) follow:
[[Page 199]]
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Acrylamide copolymerized with ethyl
acrylate and/or stryene and/or
methacrylic acid, subsequently reacted
with formaldehyde and butyl alcohol.
Acrylamide copolymerized with ethylene For use only as coatings or
and vinyl chloride in such a manner components of coatings.
that the finished copolymers have a
minimum weight average molecular
weight of 30,000 and contain not more
than 3.5 weight percent of total
polymer units derived from acrylamide,
and in such a manner that the
acrylamide portion may or may not be
subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic For use only in coatings at a
acid, homopolymer, sodium salt (CAS level not to exceed 0.01 mg/
Reg. No. 35641-59-9). in2
Acrylic and modified acrylic polymers.. Complying with Sec. 177.1010
of this chapter.
Acrylic copolymers produced by
copolymerizing 2 or more of the
acrylate monomers butyl acrylate,
ethyl acrylate, ethyl methacrylate,
methyl acrylate, methyl methacrylate,
and n-propyl methacrylate, or produced
by copolymerizing one or more of such
acrylate monomers together with one or
more of the monomers acrylic acid,
acrylonitrile, butadiene, 2-ethyl-
hexyl acrylate, fumaric acid, glycidyl
methacrylate, n-hexyl-methacrylate,
itaconic acid, methacrylic acid,
styrene, vinyl acetate, vinyl
chloride, and vinylidene chloride. The
finished copolymers shall contain at
least 50 weight percent of polymer
units derived from one or more of the
monomers butyl acrylate, ethyl
acrylate, ethyl methacrylate, methyl
acrylate, methyl methacrylate, and n-
propyl methacrylate; and shall contain
not more than 5 weight percent of
total polymer units derived from
acrylic acid, fumaric acid, glycidyl
methacrylate, n-hexyl methacrylate,
itaconic acid, and methacrylic acid.
The provision limiting the finished
acrylic copolymers to not more than 5
units derived from acrylic acid,
fumaric acid, glycidyl methacrylate, n-
hexyl methacrylate, itaconic acid, and
methacrylic acid is not applicable to
finished acrylic copolymers used as
coating adjuvants at a level not
exceeding 2 weight percent of total
coating solids.
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-alkanes 1. As emulsifiers for
in the range of C10-C18 with not less vinylidene chloride copolymer
than 50 percent C14-C16).. coatings and limited to use at
levels not to exceed 2 percent
by weight of the coating
solids.
2. As emulsifiers for
vinylidene chloride copolymer
or homopolymer coatings at
levels not to exceed a total
of 2.6 percent by weight of
coating solids. The finished
polymer contacts food only of
types identified in paragraph
(c) of this section, table 1,
under Types I, II, III, IV, V,
VIA, VIB, VII, VIII, and IX
and under conditions of use E,
F, and G described in table 2
of paragraph (c) of this
section.
2-Bromo-4'-hydroxyacetophenone......... For use only as a preservative
for coating formulations,
binders, pigment slurries, and
sizing solutions at a level
not to exceed 0.006 percent by
weight of the coating,
solution, slurry or emulsion.
Butylbenzyl phthalate.................. Complying with Sec. 178.3740
of this chapter.
Butyl oleate, sulfated, ammonium,
potassium, or sodium salt.
Butyraldehyde..........................
Captan (N-trichloromethylmercapto-4- For use only as a mold- and
cyclohexene-1, 2-dicarboximide). mildew-proofing agent in
coatings intended for use in
contact with food only of the
types identified in paragraph
(c) of this section, table 1,
under Type I, II, VI-B, and
VIII.
Castor Oil, polyoxyethylated (42 moles For use only as an emulsifier
ethylene oxide). in nitrocellulose coatings for
paper and paperboard intended
for use in contact with food
only of the types identified
in paragraph (c) of this
section, table 1, under Types
IV A, V, VII A, VIII, and IX;
and limited to use at a level
not to exceed 8 percent by
weight of the coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1- For use only:
azoniaadamantane chloride (CAS Reg. 1. As a preservative at a level
No. 4080-31-3). of 0.3 weight percent in
latexes used as pigment
binders in paper and
paperboard intended for use in
contact with nonacidic,
nonalcoholic food and under
the conditions of use
described in paragraph (c) of
this section, table 2,
conditions of use E, F, and G.
2. As a preservative at a level
not to exceed 0.07 weight
percent in latexes and 0.05
weight percent in pigment
slurries used as components of
coatings for paper and
paperboard intended for use in
contact with food.
[[Page 200]]
5-Chloro-2-methyl-4-isothiazolin-3-one For use only:
(CAS Reg. No. 26172-55-4) and 2-methyl- 1. As an antimicrobial agent
4-isothiazolin-3-one (CAS Reg. No. for polymer latex emulsions in
2682-20-4) mixture at a ratio of 3 paper coatings at a level not
parts to 1 part, manufactured from to exceed 50 parts per million
methyl-3-mercaptopropionate (CAS Reg. (based on isothiazolone active
No. 2935-90-2). The mixture may ingredients) in the coating
contain magnesium nitrate (CAS Reg. formulation.
No. 10377-60-3) at a concentration 2. As an antimicrobial agent
equivalent to the isothiazolone active for finished coating
ingredients (weight/weight). formulations and for additives
used in the manufacture of
paper and paperboard including
fillers, binders, pigment
slurries, and sizing solutions
at a level not to exceed 25
parts per million (based on
isothiazolone active
ingredients) in the coating
formulations and additives.
Copper 8-quinolinolate................. For use only as preservative
for coating formulations.
Cyclized rubber produced when natural For use only in coatings for
pale crepe rubber dissolved in phenol paper and paperboard intended
is catalytically cyclized so that the for use in contact with food
finished cyclized rubber has a melting only of the types identified
point of 145 deg.C to 155 deg.C as in paragraph (c) of this
determined by ASTM method E28-67 section, table 1, under Types
(Reapproved 1982), ``Standard Test VIII and IX.
Method for Softening Point by Ring-and-
Ball Apparatus,'' which is
incorporated by reference (copies may
be obtained from the American Society
for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408),
and contains no more than 4000 ppm of
residual-free phenol as determined by
a gas liquid chromatographic procedure
titled ``Determination of Free Phenol
in Cyclized Rubber Resin,'' which is
incorporated by reference. Copies are
available from the Center for Food
Safety and Applied Nutrition (HFS-
200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204,
or available for inspection at the
Office of the Federal Register, 800
North Capitol Street, NW., suite 700,
Washington, DC 20408.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. For use only as a preservative
No. 35691-65-7). at levels not more than 0.05
weight percent and not less
than 0.01 weight percent: in
latexes used as pigment
binders in coatings; in
pigment slurries used in
coatings; and/or in coatings
themselves. The total level of
the preservative in the
finished coating shall not
exceed 0.04 weight percent of
the finished coating solids.
Dibutyl phthalate......................
Dibutyl sebacate.......................
Di(C7,C9-alkyl) adipate................ Complying with Sec. 178.3740
of this chapter.
Dicyclohexyl phthalate.................
Diethylene glycol dibenzoate (CAS Reg. For use only as a plasticizer
No. 120-55-8). for polyvinyl acetate coatings
at a level not to exceed 5
percent by weight of the
coating solids under
conditions described in
paragraph (c) of this section,
table 2, conditions of use E,
F, and G.
Diethylene glycol ester of the adduct
of terpene and maleic anhydride.
Dihydroxy dichlorodiphenyl methane..... For use only as preservative
for coating formulations.
Dimethylpolysiloxane, 100 centistokes
viscosity.
Dimethylpolysiloxane-beta-phenylethyl
methyl polysiloxane copolymer (2:1),
200 to 400 centistokes viscosity.
N,N'-Diphenyl-p-phenylenediamine....... For use only as polymerization
inhibitor in 2-sulfoethyl
methacrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg. 1. For use only as a
No. 27138-31-4). plasticizer for polyvinyl
acetate coatings at a level
not to exceed 5 percent by
weight of the coating solids
under conditions described in
paragraph (c) of this section,
table 2, condition of use E.
2. For use only as a
plasticizer for polyvinyl
acetate coatings at a level
not to exceed 10 percent by
weight of the coating solids
under conditions described in
paragraph (c) of this section,
table 2, conditions of use F
and G.
Disodium N-octadecylsulfosuccinamate... For use only as an emulsifier
in resin latex coatings and
limited to use at a level not
to exceed 0.05% by weight of
the coating solids.
EDTA (ethylenediaminetetraacetic acid)
and its sodium and/or calcium salts.
Ethanedial, polymer with tetrahydro-4- For use only as an
hydroxy-5-methyl-2(1H)pyrimidinone, insolubilizer for starch-based
propoxylated (CAS Reg. No. 118299-90- coatings and limited to use at
4). a level not to exceed 5.0
percent by weight of the
coating.
[[Page 201]]
Ethylene-acrylic acid copolymers
produced by the copolymerization of
ethylene and acrylic acid and/or their
partial ammonium salts. The finished
copolymer shall contain no more than
25 weight percent of polymer units
derived from acrylic acid and no more
than 0.35 weight percent of residual
monomeric acrylic acid, and have a
melt index not to exceed 350 as
determined by ASTM method D1238-82,
``Standard Test Method for Flow Rates
of Thermoplastics by Extrusion
Plastometer,'' which is incorporated
by reference. Copies may be obtained
from the American Society for Testing
Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408.
Formaldehyde........................... For use only as preservative
for coating formulations.
Glyoxal................................ For use only as an
insolubilizing agent in starch-
and protein-based coatings
that contact nonalcoholic
foods, and limited to use at a
level not to exceed 6 percent
by weight of the starch or
protein fraction of the
coating solids.
Glyceryl monobutyl ricinoleate.........
Hydroxymethyl derivatives (mixture of For use only as a comonomer in
mono and poly) of [N-(1, 1-dimethyl-3- polyvinyl acetate latex
oxobutyl) acrylamide] produced by coatings and limited to use at
reacting 1 mole of the [N-(1,1- a level not to exceed 1
dimethyl-3-oxobutyl) acrylamide] with percent by weight of dry
3 moles of formaldehyde such that the polymer solids.
finished product has a maximum
nitrogen content of 6.2 percent and a
maximum hydroxyl content of 15 percent
by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium,
potassium, or sodium salt.
Maleic anhydride adduct of butadiene-
styrene copolymer.
-Methylstyrene-vinyltoluene
copolymer resins (molar ratio 1-methylstyrene to 3 vinyltoluene).
Modified kaolin clay (CAS Reg. No. 1344- For use only as a component of
00-9) is produced by the reaction of coatings in paper and
sodium silicate (CAS Reg. No. 1344-09- paperboard products at a level
8) and kaolinite clay (CAS Reg. No. not to exceed 9 percent by
1332-58-7) under hydrothermal weight of the coating intended
conditions. The reaction product has a for use in contact with food
molecular weight between 246 and 365 of Types I through IX
and consists of 46 to 55 percent described in table 1 of
silicon dioxide (Si02), 28 to 42 paragraph (c) of this section
percent aluminum oxide (A1203), and 2 under conditions of use C
to 7 percent of sodium oxide (Na20). through H described in table 2
The reaction product will not consist of paragraph (c) of this
of more than 70 percent modified section.
kaolin clay.
Naphthalene sulfonic acid-formaldehyde
condensate, sodium salt.
Oleyl alcohol..........................
Oxazolidinylethylmethacrylate (CAS For use only as a binder for
Registry No. 46236-15-1) copolymer pigment coatings as a binder
with ethyl acrylate and methyl level not to exceed 4.0
methacrylate, and containing not more percent by weight of dry paper
than 6 percent by weight of or paperboard.
oxazolidinylethylmethacrylate. Maximum
nitrogen content shall be 0.5 percent
and number average molecular weight of
that portion of the copolymer soluble
in tetrahydrofuran shall be not less
than 50,000.
Pentaerythritol tetrastearate..........
[[Page 202]]
Petroleum alicyclic hydrocarbon resins, For use only as modifiers in
or the hydrogenated product thereof, waxpolymer blend coatings for
meeting the following specifications: corrugated paperboard intended
Softening point 97 deg.C minimum, as for use in bulk packaging or
determined by ASTM method E28-67 raw fruits, raw vegetables,
(Reapproved 1982), ``Standard Test iced meat, iced fish, and iced
Method for Softening Point by Ring and poultry; and limited to use at
Ball Apparatus;'' aniline point 120 a level not to exceed 30
deg.C minimum, as determined by ASTM weight-percent of the coating
method D611-82, ``Standard Test solids.
Methods for Aniline Point and Mixed
Aniline Point of Petroleum Products
and Hydrocarbon Solvents,'' which are
incorporated by reference (copies may
be obtained from the American Society
for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408).
Specific gravity 0.96-0.99 (20 deg.C/
20 deg.C). Such petroleum hydrocarbon
resins are produced by the catalytic
polymerization of dienes and olefins
from low-boiling distillates of
cracked petroleum stocks that contain
no material boiling over 200 deg.C
and that meet the ultraviolet
absorbance limits prescribed in Sec.
172.880(b) of this chapter when
subjected to the analytical procedure
described in Sec. 172.886(b) of this
chapter, modified as follows: Treat
the product as in the first paragraph
under ``Procedure'' in Sec.
172.250(b)(3) of this chapter. Then
proceed with Sec. 172.886(b) of this
chapter, starting with the paragraph
commencing with ``Promptly complete
transfer of the sample * * *''.
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.
Polyester resin produced by reacting
the acid groups in montan wax with
ethylene glycol.
Polyethylene, oxidized................. Complying with Sec. 177.1620
of this chapter.
Polyethylene reacted with maleic
anhydride such that the modified
polyethylene has a saponification
number not in excess of 6 after
Soxhlet extraction for 24 hours with
anhydrous ethyl alcohol.
Polyoxyethylated (40 moles) tallow Not to exceed 300 p.p.m. in
alcohol sulfate, sodium salt. finished coated paper or
paperboard.
Polyoxypropylene-polyoxyethylene block
polymers (minimum molecular weight
6,800).
Polyvinyl acetate......................
Polyvinyl alcohol (minimum viscosity of
4% aqueous solution at 20 deg.C. of 4
centipoises).
Polyvinyl butyral......................
Polyvinyl formal.......................
Polyvinylidene chloride................
Polyvinyl pyrrolidone..................
Polyvinyl stearate.....................
Propylene glycol mono- and diesters of
fats and fatty acids.
Siloxanes and silicones; platinum- For use only as a surface
catalyzed reaction product of vinyl- coating. Platinum content not
containing dimethyl polysiloxane (CAS to exceed 200 parts per
Reg. Nos. 68083-19-2 and 68083-18-1) million.
with methyl hydrogen polysiloxane (CAS 1. In coatings for paper and
Reg. No. 63148-57-2) or dimethyl paperboard provided the
(methyl hydrogen) polysiloxane (CAS coating contacts food only of
Reg. No. 68037-59-2). Diallyl maleate the types identified in
(CAS Reg No. 999-21-3), dimethyl paragraph (c) of this section,
maleate (CAS Reg. No. 624-48-6), 1- table 1, under Types I, II,
ethynyl-1-cyclohexanol (CAS Reg. No. VI, and VII-B when used under
78-27-3) and vinyl acetate (CAS Reg. conditions of use E, F, and G
No. 108-05-4) may be used as optional described in table 2 of
polymerization inhibitors. paragraph (c) of this section.
2. In coatings for paper and
paperboard provided the
coating contacts food only of
the types identified in
paragraph (c) of this section,
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
of paragraph (c) of this
section.
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.
Sodium decylbenzenesulfonate...........
Sodium dihexyl sulfosuccinate..........
[[Page 203]]
Sodium n-dodecylpolyethoxy (50 moles) For use only as an emulsifier
sulfate-sodium in coatings that contact food
isododecylphenoxypolyethoxy (40 moles) only of the types identified
sulfate mixtures. in paragraph (c) of this
section, table 1, under Types
IV-A, V, VII, VIII, and IX;
and limited to use at levels
not to exceed 0.75 percent by
weight of the coating solids.
Sodium 2-ethylhexyl sulfate............
Sodium oleoyl isopropanolamide
sulfosuccinate.
Sodium pentachlorophenate.............. For use only as preservative
for coating formulations.
Sodium o-phenylphenate................. Do.
Sodium vinyl sulfonate polymerized.....
Sodium xylenesulfonate (CAS Reg. No. For use only in paper and
1300-72-7). paperboard coatings at levels
not to exceed 0.01 percent by
weight of the finished paper
and paperboard.
Styrene copolymers produced by For use only as a coating or
copolymerizing styrene with maleic component of coatings and
anhydride and its methyl and butyl limited to use at a level not
(sec- or iso-) esters. Such copolymers to exceed 1% by weight of
may contain -nitrostyrene as paper or paperboard substrate.
a polymerization chain terminator.
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 paragraph
acrylic acid, methacrylic acid, 2- (c) of this section, under use
ethyl hexyl acrylate, methyl conditions E through G in
methacrylate, and butyl acrylate. The table 2 of paragraph (c), and
styrene and alpha methyl styrene, with foods of Types VIII and
individually, may constitute from 0 to IX without use temperature
80 weight percent of the polymer. The restriction.
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-acrylic copolymers (CAS Reg. For use only as a component of
No. 25950-40-7 produced by coatings and limited to use at
polymerizing 77 to 83 parts by weight a level not to exceed 20
of styrene with 13 to 17 parts of percent by weight of the
methyl methacrylate, 3 to 4 parts of coating solids.
butyl methacrylate, 0.5 to 2.5 parts
of methacrylic acid, and 0.1 to 0.3
part of butyl acrylate such that the
finished copolymers have a minimum
number average molecular weight
greater than 100,000 and a level of
residual styrene monomer in the
polymer not to exceed 0.1 percent by
weight.
Styrene-butadiene copolymers produced
by copolymerizing styrene-butadiene
with one or more of the monomer:
acrylamide, acrylic acid, fumaric
acid, 2-hydroxyethyl acrylate,
itaconic acid, and methacrylic acid.
The finished copolymers shall contain
not more than 10 weight percent of
total polymer units derived from
acrylic acid, fumaric acid, 2-
hydroxyethyl acrylate, itaconic acid
and methacrylic acid, and shall
contain not more than 2 weight percent
of polymer units derived from
acrylamide.
Styrene-butadiene copolymers with 2-
hydroxyethyl acrylate and acrylic acid
containing not more than 15 weight
percent acrylic acid and no more than
20 weight percent of a combination of
2-hydroxyethyl acrylate and acrylic
acid.
Styrene-butadiene-vinylidene chloride For use only as coatings or
copolymers containing not more than 40 components of coatings.
weight percent of vinylidene chloride
in the finished copolymers. The
finished copolymers may contain not
more than 10 weight percent of total
polymer units derived from acrylic
acid, fumaric acid, 2-hydroxyethyl
acrylate, itaconic acid, and/or
methacrylic acid.
Styrene-dimethylstyrene-- For use only in coatings for
methylstyrene copolymers produced by paper and paperboard intended
polymerizing equimolar ratios of the for use in contact with
three comonomers such that the nonfatty food and limited to
finished copolymers have a minimum use at a level not to exceed
average molecular weight of 835 as 50% by weight of the coating
determined by ASTM method D2503-82, solids.
``Standard Test Method for Molecular
Weight (Relative Molecular Mass) of
Hydrocarbons by Thermoelectric
Measurement of Vapor Pressure,'' which
is incorporated by reference. Copies
may be obtained from the American
Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or
may be examined at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408.
Styrene-isobutylene copolymers (weight For use only in coatings for
average molecular weight not less than paper and paperboard intended
6,300). for use in contact under
conditions of use D G
described in table 2 of
paragraph (c) of this section,
with food of Types I, II, IV-
B, VI-B, VII-B, and VIII
described in table 1 of
paragraph (c) of this section;
and limited to use at a level
not to exceed 40 percent by
weight of the coating solids.
[[Page 204]]
Styrene-maleic anhydride copolymers.... For use only as a coating or
component of coatings and
limited for use at a level not
to exceed 2 percent by weight
of paper or paperboard
substrate.
Styrene-methacrylic acid copolymers
containing no more than 5 weight
percent of polymer units derived from
methacrylic acid.
Styrene-vinylidene chloride copolymers For use only as coatings or
containing not more than 40 weight components of coatings.
percent of vinylidene chloride in the
finished copolymers. The finished
copolymers may contain not more than 5
weight percent of total polymer units
derived from acrylic acid, fumaric
acid, itaconic acid, and/or
methacrylic acid.
2-Sulfoethyl methacrylate, sodium salt For use only in copolymer
[Chemical Abstracts Service No. 1804- coatings under conditions of
87-1]. use E, F, and G described in
paragraph (c) of this section,
table 2, and limited to use at
a level not to exceed 2.0
percent by weight of the dry
copolymer coating.
[p-(1,1,3,3-Tetramethylbutyl) For use only as a surface-
phenyl]-omega-hydroxypoly active agent at levels not to
(oxyethylene) hydrogen sulfate, sodium exceed 3 percent by weight of
salt mixture with -[p- vinyl acetate polymer with
(1,1,3,3-tetramethylbutyl)-phenyl]- ethylene and N-(hydroxymethyl)
omega-hydroxypoly (oxyethylene) with acrylamide intended for use in
both substances having a coatings for paper and
poly(oxyethylene) content averaging 3 paperboard intended for use in
moles. contact with foods:
1. Of the types identified in
paragraph (c) of this section,
table 1, under Types I, II,
III, IV, VI-B, and VII, and
under the conditions of use
described in paragraph (c) of
this section, table 2,
conditions of use E, F, and G.
2. Of the types identified in
paragraph (c) of this section,
table 1, under Types V, VIII
and IX and under the
conditions of use described in
paragraph (c) of this section,
table 2, conditions of use C,
D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N- For use only as an emulsifier
octadecylsulfo-succinamate. in resin latex coatings, and
limited to use at a level not
to exceed 0.05% by weight of
the coating solids.
Toluenesulfonamide-formaldehyde resins.
Vinyl acetate copolymers produced by
copolymerizing vinyl acetate with one
or more of the monomers acrylamide,
acrylic acid, acrylonitrile, bicyclo-
[2.2.1]hept-2-ene-6-methylacrylate,
butyl acrylate, crotonic acid, decyl
acrylate, diallyl fumarate, diallyl
maleate, diallyl phthalate, dibutyl
fumarate, dibutyl itaconate,
dibutylmaleate, di(2-ethylhexyl)
maleate, divinyl benzene, ethyl
acrylate, 2-ethyl-hexyl acrylate,
fumaric acid, itaconic acid, maleic
acid, methacrylic acid, methyl
acrylate, methyl methacrylate, mono(2-
ethylhexyl) maleate, monoethyl
maleate, styrene, vinyl butyrate,
vinyl crotonate, vinyl hexoate,
vinylidene chloride, vinyl
pelargonate, vinyl propionate, vinyl
pyrrolidone, vinyl stearate, and vinyl
sulfonic acid. The finished copolymers
shall contain at least 50 weight
percent of polymer units derived from
vinyl acetate and shall contain no
more than 5 weight percent of total
polymer units derived from acrylamide,
acrylic acid, crotonic acid, decyl
acrylate, dibutyl itaconate, di(2-
ethylhexyl) maleate, fumaric acid,
itaconic acid, maleic acid,
methacrylic acid, mono(2-ethylhexyl)
maleate, monoethyl maleate, vinyl
butyrate, vinyl hexoate, vinyl
pelargonate, vinyl propionate, vinyl
stearate, and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and For use only in coatings for
N-(hydroxymethyl) acrylamide paper and paperboard intended
containing not more than 6 weight for use in contact with foods:
percent of total polymer units derived 1. Of the types identified in
from N-(hydroxymethyl) acrylamide. paragraph (c) of this section,
table 1, under Types I, II,
III, IV, VI B, and VII and
under the conditions of use
described in paragraph (c) of
this section, table 2,
conditions of use E, F, and G.
2. Of the types identified in
paragraph (c) of this section,
table 1, under Types V, VIII,
and IX and under the
conditions of use described in
paragraph (c) of this section,
table 2, conditions of use C,
D, E, F, and G.
[[Page 205]]
Vinyl chloride copolymers produced by
copolymerizing vinyl chloride with one
or more of the monomers acrylonitrile;
fumaric acid and its methyl, ethyl,
propyl, butyl, amyl, hexyl, heptyl, or
octyl esters; maleic acid and its
methyl, ethyl, propyl, butyl, amyl,
hexyl, heptyl, or octyl esters; maleic
anhydride; 5-norbornene-2, 3-
dicarboxylic acid, mono-n-butyl ester;
vinyl acetate-and vinylidene chloride.
The finished copolymers shall contain
at least 50 weight percent of polymer
units derived from vinyl chloride:
shall contain no more than 5 weight
percent of total polymer units derived
from fumaric and/or maleic acid and/or
their methyl, ethyl, propyl, butyl,
amyl, heptyl, or octyl monoesters or
from maleic anhydride or from mono-n-
butyl ester of 5-norbornene-2, 3-
dicarboxylic acid (however, in any
case the finished copolymers shall
contain no more than 4 weight percent
of total polymer units derived from
mono-n-butyl ester of 5-norbornene-2,3-
dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-
modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-
modified copolymers reacted with
trimellitic anhydride.
Vinylidene chloride copolymers produced
by copolymerizing vinylidene chloride
with one or more of the monomers
acrylamide acrylic acid,
acrylonitrile, butyl acrylate, butyl
methacrylate ethyl acrylate, ethyl
methacrylate, fumaric acid, itaconic
acid, methacrylic acid, methyl
acrylate, methyl methacrylate,
octadecyl methacrylate, propyl
acrylate, propyl methacrylate, vinyl
chloride and vinyl sulfonic acid. The
finished copolymers shall contain at
least 50 weight percent of polymer
units derived from vinylidene
chloride; and shall contain no more
than 5 weight percent of total polymer
units derived from acrylamide, acrylic
acid, fumaric acid, itaconic acid,
methacrylic acid, octadecyl
methacrylate, and vinyl sulfonic acid.
Colorants:.............................
Aluminum............................. For use as a colorant only.
Aluminum hydrate..................... Do.
Aluminum and potassium silicate Do.
(mica).
Aluminum mono-, di-, and tristearate. Do.
Aluminum silicate (China clay)....... Do.
Barium sulfate....................... Do.
Bentonite............................ Do.
Bentonite, modified with Do.
dimethyldioctadecylammonium ion.
Burnt umber.......................... Do.
Calcium carbonate.................... Do.
Calcium silicate..................... Do.
Calcium sulfate...................... Do.
Carbon black (channel process)....... Do.
Cobalt aluminate..................... Do.
Diatomaceous earth................... Do.
Iron oxides.......................... Do.
Magnesium oxide...................... Do.
Magnesium silicate (talc)............ Do.
Phthalocyanine blue (C.I. pigment Do.
blue 15, 15:1, 15:2, 15:3, and 15:4;
C.I. No. 74160; CAS Reg. No. 147-14-
8).
Raw sienna........................... Do.
Silica............................... Do.
Tartrazine lake (certified FD&C Do.
Yellow No. 5 only).
Titanium dioxide..................... Do.
Titanium dioxide-barium sulfate...... Do.
Titanium dioxide-magnesium........... Do.
silicate...........................
Zinc carbonate....................... Do.
Zinc oxide........................... Do.
------------------------------------------------------------------------
(c) The food-contact surface of the paper and paperboard 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 this paragraph, shall
[[Page 206]]
yield net chloroform-soluble extractives (corrected for wax, petrolatum,
mineral oil and zinc extractives as zinc oleate) not to exceed 0.5
milligram per square inch of food-contact surface as determined by the
methods described in paragraph (d) of this section.
Table 1--Types of Raw and Processed Foods
I. Nonacid, aqueous products; may contain salt or sugar or both (pH
above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and
including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
contain salt, and including water-in-oil emulsions of low- or high-fat
content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of
this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end
test required).
IX. Dry solids with the surface containing free fat or oil.
Table 2--Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food-
Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and
Beverages
----------------------------------------------------------------------------------------------------------------
Food-simulating solvents
------------------------------------------------------------------
Water Heptane\1\ 8 percent 50 percent
Condition of use Types of food ---------------------------------- alcohol alcohol
(see table 1) --------------------------------
Time and Time and Time and Time and
temperature temperature temperature temperature
----------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B, VII-B. 250 deg.F, 2 ............... ............... ..............
sterilized (e.g., over 212 hr.
deg.F).
III, IV-A, VII- ......do....... 150 deg.F, 2 ............... ..............
A. hr.
B. Boiling water sterilized. II, VII-B...... 212 deg.F, 30 ............... ............... ..............
min.
III, VII-A..... ......do....... 120 deg.F, 30 ............... ..............
min.
C. Hot filled or pasteurized II, IV-B, VII-B Fill boiling, ............... ............... ..............
above 150 deg.F. cool to 100
deg.F.
III, IV-A, VII- ......do....... 120 deg.F, 15 ............... ..............
A. min.
V, IX.......... ............... ......do....... ............... ..............
D. Hot filled or pasteurized II, IV-B, VI-B, ............... ............... ............... ..............
below 150 deg.F.
VII-B.......... 150 deg.F, 2 ............... ............... ..............
hr.
III, IV-A, VII- ......do....... 100 deg.F, 30 ............... ..............
A. min.
V, IX.......... ............... ......do....... ............... ..............
VI-A........... ............... ............... 150 deg.F, 2 ..............
hr.
VI-C........... ............... ............... ............... 150 deg.F, 2
hr.
E. Room temperature filled I, II, IV-B, VI- 120 deg.F, 24 ............... ............... ..............
and stored (no thermal B, VII-B. hr.
treatment in the container).
III, IV-A, VII- ......do....... 70 deg.F, 30 ............... ..............
A. min.
V, IX.......... ............... ......do....... ............... ..............
VI-A........... ............... ............... 120 deg.F, 24 ..............
hr.
VI-C........... ............... ............... ............... 120 deg.F, 24
hr.
F. Refrigerated storage (no III, IV-A, VII- 70 deg.F, 48 70 deg.F, 30 ............... ..............
thermal treatment in the A. hr. min.
container).
I, II, IV-B, VI- ......do....... ............... ............... ..............
B, VII-B.
VI-A........... ............... ............... 70 deg.F, 48 ..............
hr.
VI-C........... ............... ............... ............... 70 deg.F, 48
hr.
G. Frozen storage (no I, II, IV-B, 70 deg.F, 24 ............... ............... ..............
thermal treatment in the VII-B. hr.
container).
III, VII-A..... ......do....... 70 deg.F, 30 ............... ..............
min.
H. Frozen or refrigerated
storage: Ready-prepared
foods intended to be
reheated in container at
time of use:
1. Aqueous or oil-in-water I, II, IV-B, 212 deg.F, 30 ............... ............... ..............
emulsion of high- or low- VII-B. min.
fat.
[[Page 207]]
2. Aqueous, high- or low- III, IV-A, VII- ......do....... 120 deg.F, 30 ............... ..............
free oil or fat. A, IX. min.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractability results must be divided by a factor of five in arriving at the extractability for a
food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required
in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk
packaging of iced meat, iced fish, and iced poultry.
(d) Analytical methods--(1) Selection of extractability conditions.
First ascertain the type of food product (table 1, paragraph (c) of this
section) that is being packed commercially in the paper or paperboard
and the normal conditions of thermal treatment used in packaging the
type of food involved. Using table 2, paragraph (c) of this section,
select the food-simulating solvent or solvents and the time-temperature
exaggerations of the paper or paperboard use conditions. Having selected
the appropriate food-simulating solvent or solvents and the time-
temperature exaggeration over normal use, follow the applicable
extraction procedure.
(2) Reagents--(i) Water. All water used in extraction procedures
should be freshly demineralized (deionized) distilled water.
(ii) n-Heptane. Reagent grade, freshly redistilled before use, using
only material boiling at 208 deg.F.
(iii) Alcohol. 8 or 50 percent (by volume), prepared from
undenatured 95 percent ethyl alcohol diluted with demineralized
(deionized) distilled water.
(iv) Chloroform. Reagent grade, freshly redistilled before use, or a
grade having an established consistently low blank.
(3) Selection of test method. Paper or paperboard ready for use in
packaging shall be tested by use of the extraction cell described in
``Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), sections 21.010-21.015, under ``Exposing
Flexible Barrier Materials for Extraction,'' which is incorporated by
reference (copies may be obtained from the Association of Official
Analytical Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or may be examined at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408); also described in ASTM method F34-76 (Reapproved 1980),
``Standard Test Method for Liquid Extraction of Flexible Barrier
Materials,'' which is incorporated by reference (copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408), except that formed paper and paperboard products may be tested
in the container by adapting the in-container methods described in
Sec. 175.300(e) of this chapter. Formed paper and paperboard products
such as containers and lids, that cannot be tested satisfactorily by any
of the above methods may be tested in specially designed extraction
equipment, usually consisting of clamping devices that fit the closure
or container so that the food-contact surface can be tested, or, if flat
samples can be cut from the formed paper or paperboard products without
destroying the integrity of the food-contact surface, they may be tested
by adapting the following ``sandwich'' method:
(i) Apparatus. (a) Thermostated (plus-minus1.0 deg.F)
water bath, variable between 70 deg.F and 120 deg.F water bath cover
capable of holding at least one 800-milliliter beaker partially
submersed in bath.
(b) Analytical balance sensitive to 0.1 milligram with an
approximate capacity of 100 grams.
(c) Tongs.
[[Page 208]]
(d) Hood and hot-plate facilities.
(e) Forced draft oven.
For each extraction, the following additional apparatus is necessary:
(f) One No. 2 paper clip.
(g) One 800-milliliter beaker with watch-glass cover.
(h) One 250-milliliter beaker.
(i) Five 2\1/2\-inch-square aluminum screens (standard aluminum
window screening is acceptable).
(j) One wire capable of supporting sample stack.
(ii) Procedure. (a) For each extraction, accurately cut eight 2\1/
2\-inch-square samples from the formed paper or paperboard product to be
tested.
(b) Carefully stack the eight 2\1/2\-inch-square samples and the
five 2\1/2\-inch-square aluminum screens in sandwich form such that the
food-contact side of each sample is always next to an aluminum screen,
as follows: Screen, sample, sample, screen, sample, sample, screen, etc.
Clip the sandwich together carefully with a No. 2 paper clip, leaving
just enough space at the top to slip a wire through.
(c) Place an 800-milliliter beaker containing 100-milliliters of the
appropriate food-simulating solvent into the constant temperature bath,
cover with a watch glass and condition at the desired temperature.
(d) After conditioning, carefully lower the sample sandwich with
tongs into the beaker.
(e) At the end of the extraction period, using the tongs, carefully
lift out the sample sandwich and hang it over the beaker with the wire.
(f) After draining, pour the food-simulating solvent solution into a
tared 250-milliliter beaker. Rinse the 800-milliliter beaker three
times, using a total of not more than 50 milliliters of the required
solvent.
(g) Determine total nonvolatile extractives in accordance with
paragraph (d)(5) of this section.
(4) Selection of samples. Quadruplicate samples should be tested,
using for each replicate sample the number of cups, containers, or
preformed or converted products nearest to an area of 100 square inches.
(5) Determination of amount of extractives--(i) Total residues. At
the end of the exposure period, remove the test container or test cell
from the oven and combine the solvent for each replicate in a clean
Pyrex (or equivalent) flask or beaker being sure to rinse the test
container or cell with a small quantity of clean solvent. Evaporate the
food-simulating solvents to about 100 milliliters in the flask or
beaker, and transfer to a clean, tared evaporating dish (platinum or
Pyrex), washing the flask three times with small portions of solvent
used in the extraction procedure, and evaporate to a few milliliters on
a nonsparking, low-temperature hotplate. The last few milliliters should
be evaporated in an oven maintained at a temperature of approximately
221 deg.F. Cool the evaporating dish in a desiccator for 30 minutes and
weigh the residue to the nearest 0.1 milligram, (e). Calculate the
extractives in milligrams per square inch of the container or sheeted
paper or paperboard surface.
(a) Water and 8- and 50-percent alcohol. Milligrams extractives per
square inch=(e)/(s).
(b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)
where:
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane under
exaggerated time-temperature test conditions compared to the
amount extracted by a fat or oil under exaggerated conditions
of thermal sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Corrected chloroform-soluble extractives residue.
e' or ee' is substituted for e in the above equations when necessary.
If when calculated by the equations in paragraph (d)(5)(i) (a) and (b)
of this section, the extractives in milligrams per square inch exceeds
the limitations prescribed in paragraph (c) of this section, proceed to
paragraph (d)(5)(ii) of this section (method for determining the amount
of chloroform-soluble extractives residues).
(ii) Chloroform-soluble extractives residue. Add 50 milliliters of
chloroform (freshly distilled reagent grade or a grade having an
established consistently low blank) to the dried and weighed residue,
(e), in the evaporating dish obtained in paragraph (d)(5)(i) of this
section. Warm carefully, and filter
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through Whatman No. 41 filter paper (or equivalent) in a Pyrex (or
equivalent) funnel, collecting the filtrate in a clean, tared
evaporating dish (platinum or Pyrex). Repeat the chloroform extraction,
washing the filter paper with this second portion of chloroform. Add
this filtrate to the original filtrate and evaporate the total down to a
few milliliters on a low-temperature hotplate. The last few milliliters
should be evaporated in an oven maintained at approximately 221 deg.F.
Cool the evaporating dish in a desiccator for 30 minutes and weigh to
the nearest 0.1 milligram to get the chloroform-soluble extractives
residue ('). This ' is substituted for e in the equations in paragraph
(d)(5)(i) (a) and (b) of this section. If the chloroform-soluble
extractives in milligrams per square inch still exceeds the limitation
prescribed in paragraph (c) of this section, proceed to paragraph
(d)(5)(iii) of this section (method for determining corrected
chloroform-soluble extractives residue).
(iii) Corrected chloroform-soluble extractives residue--(a)
Correction for zinc extractives. Ash the residue in the evaporating dish
by heating gently over a Meker-type burner to destroy organic matter and
hold at red heat for about 1 minute. Cool in the air for 3 minutes, and
place the evaporating dish in the desiccator for 30 minutes and weigh to
the nearest 0.1 milligram. Analyze this ash for zinc by standard
Association of Official Agricultural Chemists methods or equivalent.
Calculate the zinc in the ash as zinc oleate, and subtract from the
weight of chloroform-soluble extractives residue (') to obtain the zinc-
corrected chloroform-soluble extractives residue (e'). This e' is
substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of
this section.
(b) Correction for wax, petrolatum, and mineral oil--(1) Apparatus.
Standard 10 millimeter inside diameter x 60 centimeter chromatographic
column (or standard 50-milliliter buret with an inside diameter of 10-11
millimeters) with a stopcock of glass, perfluorocarbon resin, or
equivalent material. The column (or buret) may be optionally equipped
with an integral coarse, fritted glass disc and the top of the column
(or buret) may be optionally fitted with a 100-millimeter solvent
reservoir.
(2) Preparation of column. Place a snug pledget of fine glass wool
in the bottom of the column (or buret) if the column (or buret) is not
equipped with integral coarse, fritted glass disc. Overlay the glass
wool pledget (or fritted glass disc) with a 15-20 millimeter deep layer
of fine sand. Measure in a graduated cylinder 15 milliliters of
chromatographic grade aluminum oxide (80-200 mesh) that has been tightly
settled by tapping the cylinder. Transfer the aluminum oxide to the
chromatographic tube, tapping the tube during and after the transfer so
as to tightly settle the aluminum oxide. Overlay the layer of aluminum
oxide with a 1.0-1.5 centimeter deep layer of anhydrous sodium sulfate
and on top of this place an 8-10 millimeter thick plug of fine glass
wool. Next carefully add about 25 milliliters of heptane to the column
with stopcock open, and allow the heptane to pass through the column
until the top level of the liquid just passes into the top glass wool
plug in the column, and close stopcock.
(3) Chromatographing of sample extract--(i) For chloroform residues
weighing 0.5 gram or less. To the dried and weighed chloroform-soluble
extract residue in the evaporating dish, obtained in paragraph
(d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If
necessary, heat carefully to dissolve the residue. Additional heptane
not to exceed a total volume of 50 milliliters may be used if necessary
to complete dissolving. Cool to room temperature. (If solution becomes
cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this
section to obtain an aliquot of heptane solution calculated to contain
0.1-0.5 gram of chloroform-soluble extract residue.) Transfer the clear
liquid solution to the column (or buret). Rinse the dish with 10
millimeters of additional heptane and add to column. Allow the liquid to
pass through the column into a clean, tared evaporating dish (platinum
or Pyrex) at a dropwise rate of about 2 milliliters per minute until the
liquid surface reaches the top glass wool plug; then close the stopcock
temporarily. Rinse the Pyrex flask which contained the
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filtrate with an additional 10-15 milliliters of heptane and add to the
column. Wash (elute) the column with more heptane collecting about 100
milliliters of total eluate including that already collected in the
evaporating dish. Evaporate the combined eluate in the evaporating dish
to dryness on a steam bath. Dry the residue for 15 minutes in an oven
maintained at a temperature of approximately 221 deg.F. Cool the
evaporating dish in a desiccator for 30 minutes and weigh the residue to
the nearest 0.1 milligram. Subtract the weight of the residue from the
weight of chloroform-soluble extractives residue (') to obtain the wax-,
petrolatum-, and mineral oil-corrected chloroform-soluble extractives
residue (e'). This e' is substituted for e in the equations in paragraph
(d)(5)(i) (a) and (b) of this section.
(ii) For chloroform residues weighing more than 0.5 gram. Redissolve
the dried and weighed chloroform-soluble extract residue as described in
paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately
larger quantities of heptane. Transfer the heptane solution to an
appropriate-sized volumetric flask (i.e., a 250-milliliter flask for
about 2.5 grams of residue) and adjust to volume with additional
heptane. Pipette out an aliquot (about 50 milliliters) calculated to
contain 0.1-0.5 gram of the chloroform-soluble extract residue and
analyze chromatographically as described in paragraph
(d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the
dried residue from the heptane eluate must be multiplied by the dilution
factor to obtain the weight of wax, petrolatum, and mineral oil residue
to be subtracted from the weight of chloroform-soluble extractives
residue (') to obtain the wax-, petrolatum-, and mineral oil-corrected
chloroform-soluble extractives residue (e'). This e' is substituted for
e in the equations in paragraph (d)(5)(i) (a) and (b) of this section.
(Note: In the case of chloroform-soluble extracts which contain high
melting waxes (melting point greater than 170 deg.F), it may be
necessary to dilute the heptane solution further so that a 50-milliliter
aliquot will contain only 0.1-0.2 gram of the chloroform-soluble extract
residue.)
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter, except where the
copolymers are restricted to use in contact with food only of the type
identified in paragraph (c), table 1 under Category VIII.
[42 FR 14554, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 176.170, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.