This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176]
[Page 190]
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 A [Reserved]
Subpart B--Substances for Use Only as Components of Paper and Paperboard
Sec.
176.110 Acrylamide-acrylic acid resins.
176.120 Alkyl ketene dimers.
176.130 Anti-offset substances.
176.150 Chelating agents used in the manufacture of paper and
paperboard.
176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane
sulfonyl glycine.
176.170 Components of paper and paperboard in contact with aqueous and
fatty foods.
176.180 Components of paper and paperboard in contact with dry food.
176.200 Defoaming agents used in coatings.
176.210 Defoaming agents used in the manufacture of paper and
paperboard.
176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
176.260 Pulp from reclaimed fiber.
176.300 Slimicides.
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
Source: 42 FR 14554, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 176 appear at 61 FR
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.
Subpart A [Reserved]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.110]
[Page 190-191]
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. 176.110 Acrylamide-acrylic acid resins.
Acrylamide-acrylic acid resins may be safely used as components of
articles intended for use in producing, manufacturing, packing,
processing,
[[Page 191]]
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of this section.
(a) Acrylamide-acrylic acid resins are produced by the
polymerization of acrylamide with partial hydrolysis or by the
copolymerization of acrylamide and acrylic acid.
(b) The acrylamide-acrylic acid resins contain less than 0.2 percent
residual monomer.
(c) The resins are used as adjuvants in the manufacture of paper and
paperboard in amounts not to exceed that necessary to accomplish the
technical effect and not to exceed 2 percent by weight of the paper or
paperboard.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.120]
[Page 191]
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. 176.120 Alkyl ketene dimers.
Alkyl ketene dimers may be safely used as a component of articles
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of this section.
(a) The alkyl ketene dimers are manufactured by the
dehydrohalogenation of the acyl halides derived from the fatty acids of
animal or vegetable fats and oils.
(b) The alkyl ketene dimers are used as an adjuvant in the
manufacture of paper and paperboard under such conditions that the alkyl
ketene dimers and their hydrolysis products dialkyl ketones do not
exceed 0.4 percent by weight of the paper or paperboard.
(c) The alkyl ketene dimers may be used in the form of an aqueous
emulsion which may contain sodium lignosulfonate as a dispersant.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.130]
[Page 191]
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. 176.130 Anti-offset substances.
Substances named in paragraphs (b) and (c) of this section may be
safely used to prevent the transfer of inks employed in printing and
decorating paper and paperboard used for food packaging in accordance
with the provisions of this section:
(a) The substances are applied to the nonfood contact, printed side
of the paper or paperboard in an amount not greater than that required
to accomplish the technical effect nor greater than any specific
limitations, where such are provided.
(b) Anti-offset powders are prepared from substances that are
generally recognized as safe in food, substances for which prior
sanctions or approvals were granted and which are used in accordance
with the specific provisions of such sanction or approval, and
substances named in paragraph (c) of this section.
(c) The substances permitted are as follows:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Carbon tetrachloride......................
Methyl hydrogen polysiloxanes.............
Industrial starch--modified............... Complying with Sec.
178.3520 of this chapter.
Stannous oleate...........................
Zinc-2-ethyl hexoate......................
------------------------------------------------------------------------
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.150]
[Page 191]
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. 176.150 Chelating agents used in the manufacture of paper and paperboard.
The substances named in paragraph (a) of this section may be safely
used in the manufacture of paper and paperboard, in accordance with the
conditions prescribed in paragraphs (b) and (c) of this section:
(a) Chelating agents:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Ammonium fructoheptonate..................
Ammonium glucoheptonate...................
Disodium ethylenediamine tetraacetate.....
Pentasodium salt of diethylenetriamine
pentaacetate.
Sodium fructoheptonate....................
Sodium glucoheptonate.....................
Tetrasodium ethylenediamine tetraacetate..
Trisodium N-hydroxyethyl ethylenediamine
triacetate.
------------------------------------------------------------------------
(b) Any one or any combination of the substances named is used or
intended for use as chelating agents.
(c) The substances are added in an amount not greater than that
required to accomplish the intended technical effect nor greater than
any specific limitation, where such is provided.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.160]
[Page 191-192]
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. 176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.
The chromium (Cr III) complex of N-ethyl - N -heptadecylfluoro-
octane sulfonyl glycine containing up to 20 percent by weight of the
chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may
be safely used as a
[[Page 192]]
component of paper for packaging dry food when used in accordance with
the following prescribed conditions.
(a) The food additive is used as a component of paper in an amount
not to exceed 0.5 percent by weight of the paper.
(b)(1) The food-contact surface of the paper is overcoated with a
polymeric or resinous coating at least \1/3\-mil in thickness, that
meets the provision of Sec. 176.170; or
(2) The treated paper forms one or more plies of a paper in a
multiwall bag and is separated from the food by at least one ply of
packaging films or grease-resistant papers which serves as a functional
barrier between the food additive and the food. Such packaging films or
grease-resistant papers conform with appropriate food additive
regulations.
(c) The labeling of the food additive shall contain adequate
directions for its use to insure compliance with the requirements of
paragraphs (a) and (b) of this section.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.170]
[Page 192-217]
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:
------------------------------------------------------------------------
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-[beta]- 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 [beta]- 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).
[[Page 193]]
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.
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.
[[Page 194]]
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/in\2\
(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.
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.
[[Page 195]]
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).
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.
[[Page 196]]
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).
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...........
[[Page 197]]
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.
Glyceryl lactostearate.................
Glyceryl mono-1,2-hydroxystearate......
Glyceryl monoricinoleate...............
Guar gum modified by treatment with For use only as a retention aid
[beta]-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[dprime], N[dprime]- For use only as a water-
Hexakis (methoxymethyl)-1,3,5-triazine- repellent applied to the
2,4,6-triamine polymer with stearyl surface of paper and
alcohol, [alpha]-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.
[[Page 198]]
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).
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.
[[Page 199]]
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[ to exceed 0.44 percent
([gamma],[omega]-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-[beta]-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.
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.
[[Page 200]]
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.
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).
[[Page 201]]
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).
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.
[[Page 202]]
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 8.660.4 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 8.660.4 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.
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.
[[Page 203]]
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
toWater 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.
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.
[[Page 204]]
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.
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).
[[Page 205]]
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:
------------------------------------------------------------------------
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.
[[Page 206]]
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.
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.
[[Page 207]]
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,
5100 Paint Branch Pkwy., College Park,
MD 20740, 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.
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.
[[Page 208]]
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.
[alpha]-Methylstyrene-vinyltoluene
copolymer resins (molar ratio 1[alpha]-
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..........
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.
[[Page 209]]
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..........
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 [beta]-nitrostyrene as a paper or paperboard substrate.
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.
[[Page 210]]
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-[alpha]- 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.
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.
[alpha][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 [alpha]-[p-(1,1,3,3- vinyl acetate polymer with
tetramethylbutyl)-phenyl]-omega- ethylene and N-(hydroxymethyl)
hydroxypoly (oxyethylene) with both acrylamide intended for use in
substances having a poly(oxyethylene) coatings for paper and
content averaging 3 moles. paperboard intended for use in
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.
[[Page 211]]
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.
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.
[[Page 212]]
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
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.
[[Page 213]]
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.
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),
[[Page 214]]
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 (1.0 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.
(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,
[[Page 215]]
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 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
[[Page 216]]
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 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
[[Page 217]]
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.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.180]
[Page 217-221]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table of Contents
Subpart B--Substances for Use Only as Components of Paper and Paperboard
Sec. 176.180 Components of paper and paperboard in contact with dry food.
The substances listed in this section may be safely used as
components of the uncoated or coated food-contact surface of paper and
paperboard intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding dry
food of the type identified in Sec. 176.170(c), table 1, under Type
VIII, subject to the provisions of this section.
(a) The substances are used in amounts not to exceed that required
to accomplish their intended physical or technical effect, and are so
used as to accomplish no effect in food other than that ordinarily
accomplished by packaging.
(b) The substances permitted to be used include the following:
(1) Substances that by Sec. 176.170 and other applicable regulations
in parts 170 through 189 of this chapter may be safely used as
components of the uncoated or coated food-contact surface of paper and
paperboard, subject to the provisions of such regulation.
(2) Substances identified in the following list:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Acrylamide polymer with sodium 2- For use at a level not to
acrylamido-2-methylpropane-sulfonate exceed 0.015 weight percent of
(CAS Reg. No. 38193-60-1). dry fiber.
(2-Alkenyl) succinic anhydrides in
which the alkenyl groups are derived
from olefins which contain not less
than 78 percent C30 and higher groups
(CAS Reg. No. 70983-55-0)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) For use as a polymerization
ethoxy]ethyl]disodium sulfosuccinate. emulsifier and latex emulsion
stabilizer at levels not to
exceed 5 percent by weight of
total emulsion solids.
Alkyl mono- and disulfonic acids,
sodium salts (produced from n-alkanes
in the range of C10-C18 with not less
than 50 percent C14-C16)..
Aluminum and calcium salts of FD & C Colorant.
dyes on a substrate of alumina.
Ammonium nitrate.......................
Amylose................................
Barium metaborate...................... For use as preservative in
coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS For use only as a preservative
Registry No. 2634-33-5). in paper coating compositions
and limited to use at a level
not to exceed 0.02 mg/in\2\
(0.0031 mg/cm\2\) of finished
paper and paperboard.
N,N'-Bis(hydroxyethyl)lauramide........
Bis(trichloromethyl) sulfone C.A. For use only as a preservative
Registry No. 3064-70-8. in coatings.
Borax.................................. For use as preservative in
coatings.
Boric acid............................. Do.
sec-Butyl alcohol......................
Butyl benzyl phthalate.................
Candelilla wax.........................
Carbon tetrachloride...................
Castor oil, polyoxyethylated (42 moles
ethylene oxide)..
Cationic soy protein hydrolyzed For use only as a coating
(hydrolyzed soy protein isolate adhesive, pigment structuring
modified by treatment with 3-chloro-2- agent, and fiber retention
hydroxypropyl-trimethylammonium aid.
chloride).
Cationic soy protein (soy protein For use only as a coating
isolate modified by treatment with 3- adhesive, pigment structuring
chloro-2-hydroxypropyltrimethyl- agent, and fiber retention
ammonium chloride). aid.
Chloral hydrate........................ Polymerization reaction-control
agent.
N-Cyclohexyl-p-toluene sulfonamide.....
2,5-Di-tert-butyl hydroquinone.........
Diethanolamine.........................
Diethylene glycol dibenzoate (CAS Reg. For use only as a plasticizer
No. 120-55-8). in polymeric substances.
Diethylene glycol monobutyl ether......
Diethylene glycol monoethyl ether......
Diethylenetriamine.....................
N,N-Diisopropanolamide of tallow fatty
acids..
N-[(dimethylamino)methyl]acrylamide
polymer with acrylamide and styrene..
[[Page 218]]
N,N-Dioleoylethylenediamine, N,N-
dilinoeoyl-ethylenediamine, and N-
oleoyl-N-linoleoyl-ethylenediamine
mixture produced when tall oil fatty
acids are made to react with
ethylenediamine such that the finished
mixture has a melting point of 212
deg.-228 deg.F, as determined by ASTM
method D127-60, and an acid value of
10 maximum. ASTM Method D127-60
"Standard Method of Test for Melting
Point of Petrolatum and
Microcrystalline Wax" (Revised 1960)
is incorporated by reference. Copies
are available from University
Microfilms International, 300 N. Zeeb
Rd., Ann Arbor, MI 48106, or available
for inspection at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408..
Diphenylamine..........................
Dipropylene glycol dibenzoate (CAS Reg. For use only as plasticizer in
No. 27138-31-4). polymeric substances.
Disodium N-octadecylsulfosuccinamate...
tert-Dodecyl thioether of polyethylene
glycol..
Erucamide (erucylamide)................
Ethanedial, polymer with tetrahydro-4-
hydroxy-5-methyl-2(1H)pyrimidinone,
propoxylated..
Ethylene oxide......................... Fumigant in sizing.
Ethylene oxide adduct of mono-(2-
ethylhexyl) o-phosphate..
Fatty acid (C12-C18) diethanolamide....
Fish oil fatty acids, hydrogenated,
potassium salt..
Formaldehyde...........................
Glyceryl monocaprate...................
Glyceryl tribenzoate (CAS Reg. No. 614- For use only as a plasticizer
33-5). in polymeric coatings.
Glyoxal................................
Glyoxal-urea-formaldehyde condensate For use as an insolubilizer for
(CAS Reg. No. 27013-01-0) formed by starch in coatings.
reaction in the molar ratio of
approximately 47:33:15, respectively.
The reaction product has a number
average molecular weight of 278
14 as determined by a suitable
method.
Glyoxal-urea polymer (CAS Reg. No. For use as an insolubilizer for
53037-34-6). starch.
Hexamethylenetetramine................. Polymerization crosslinking
agent for protein, including
casein. As neutralizing agent
with myristochromic chloride
complex and stearato-chromic
chloride complex.
Hexylene glycol (2-methyl-2,4-
pentanediol)..
Hydroabietyl alcohol...................
5-Hydroxymethoxymethyl-1-aza-3,7- For use only as an
dioxabicyclo[3.3.0] octane, 5- antibacterial preservative.
hydroxymethyl-1-aza-3,7-
dioxabicyclo[3.3.0]octane, and 5-
hydroxypoly-[methyleneoxy]methyl-1-aza-
3,7-dioxabicyclo[3.3.0] octane mixture.
Imidazolium compounds, 2-(C17 and C17- For use only at levels not to
unsaturated alkyl)-1-[2-(C18 and C18- exceed 0.5 percent by weight
unsaturated amido)ethyl]-4,5-dihydro-1- of the dry paper and
methyl, methyl sulfates (CAS Reg. No. paperboard.
72749-55-4)..
Isopropanolamine hydrochloride.........
Isopropyl m- and p-cresol (thymol
derived)..
Itaconic acid..........................
Maleic anhydride-diisobutylene
copolymer, ammonium or sodium salt..
Melamine-formaldehyde modified with: Basic polymer.
Alcohols (ethyl, butyl, isobutyl,
propyl, or isopropyl).
Diethylenetriamine.
Imino-bis-butylamine.
Imino-bis-ethyleneimine.
Imino-bis-propylamine.
Polyamines made by reacting
ethylenediamine or trimethylenediamine
with dichloroethane or
dichloropropane.
Sulfanilic acid.
Tetraethylenepentamine.
Triethylenetetramine.
Methyl alcohol.........................
Methyl esters of mono-, di-, and
tripropylene glycol..
Methyl napthalene sulfonic acid-
formaldehyde condensate, sodium salt..
Methylated poly(N-1,2-dihydroxyethylene- For use only only as an in
1,3-imidazolidin-2-one). solubilizer for starch.
[[Page 219]]
Modified polyacrylamide resulting from For use only as a dry strength
an epichlorohydrin addition to a and pigment retention aid
condensate of formaldehyde- agent employed prior to the
dicyandiamide-diethylene triamine and sheetforming operation in the
which product is then reacted with manufacture of paper and
polyacrylamide and urea to produce a paperboard and used at a level
resin having a nitrogen content of 5.6 not to exceed 1 percent by
to 6.3 percent and having a minimum weight of dry fibers.
viscosity in 56 percent-by-weight
aqueous solution of 200 centipoises at
25 deg.C, as determined by LVT-series
Brookfield viscometer using a No. 4
spindle at 60 r.p.m. (or equivalent
method).
Mono- and di(2-alkenyl)succinyl esters For use only as an emulsifier.
of polyethylene glycol containing not
less than 90 percent of the diester
product and in which the alkenyl
groups are derived from olefins that
contain not less than 95 percent of
C15-C21 groups.
Monoglyceride citrate..................
Myristo chromic chloride complex.......
Napthalene sulfonic acid-formaldehyde
condensate, sodium salt..
Nickel.................................
[beta]-Nitrostyrene.................... Basic polymer.
Octadecanoic acid, reaction products For use prior to sheet forming
with 2-[(2-aminoethyl)amino]ethanol at levels not to exceed 12
and urea (CAS Reg. No. 68412-14-6), pounds per ton of paper.
and the acetate salts thereof (CAS
Reg. No. 68784-21-4), which may be
emulsified with ethoxylated tallow
alkyl amines (CAS Reg. No. 61791-26-2).
[alpha]-cis-9-Octadecenyl-omega-
hydroxypoly (oxyethylene); the
octadecenyl group is derived from
oleyl alcohol and the
poly(oxyethylene) content averages not
less than 20 moles..
[alpha]-(p-Nonylphenyl)-omega-
hydroxypoly (oxyethylene) sulfate,
ammonium salt; the nonyl group is a
propylene trimer isomer and the poly
(oxyethylene) content averages 9 or 30
moles..
Oleic acid reacted with N-alkyl-(C16-
C18) trimethylenediamine..
Oxidized soy isolate having 50 to 70 For use as a binder adhesive
percent of its cystine residues component of coatings.
oxidized to cysteic acid.
Petroleum alicyclic hydrocarbon resins, For use as modifiers at levels
or the hydrogenated product thereof, up to 30 weight-percent of the
complying with the identity prescribed solids content of wax-polymer
in Sec. 176.170(b)(2). blend coatings.
Petroleum hydrocarbon resins (produced
by the catalytic polymerization and
subsequent hydrogenation of styrene,
vinyltoluene, and indene types from
distillates of cracked petroleum
stocks)..
Petroleum hydrocarbons, light and
odorless..
o-Phthalic acid modified hydrolyzed soy
protein isolate..
Pine oil...............................
Poly(2-aminoethyl acrylate nitrate-co-2-
hydroxypropyl acrylate) complying with
the identity described in Sec.
176.170(a)..
Polyamide-epichloro hydrin modified
resins resulting from the reaction of
the initial caprolactam-itaconic acid
product with diethylenetriamine and
then condensing this prepolymer with
epichlorohydrin to form a cationic
resin having a nitrogen content of 11-
15 percent and chlorine level of 20-23
percent on a dry basis..
Polyamide-ethyleneimine-epichlorohydrin
resin is prepared by reacting
equimolar amounts of adipic acid and
three amines (21 mole percent of 1,2-
ethanediamine, 51 mole percent of N-(2-
aminoethyl)-1,3-propanediamine, and 28
mole percent of N, N'-1,2-
ethanediylbis(1,3-propanediamine)) to
form a basic polyamidoamine which is
modified by reaction with
ethyleneimine (5.5:1.0
ethyleneimine:polyamidoamine). The
modified polyamidoamine is reacted
with a crosslinking agent made by
condensing approximately 34 ethylene
glycol units with
(chloromethyl)oxirane, followed by pH
adjustment with formic acid or
sulfuric acid to provide a finished
product as a formate (CAS Reg. No.
114133-44-7) or a sulfate (CAS Reg.
No. 167678-43-5), having a weight-
average molecular weight of 1,300,000
and a number-average molecular weight
of 16,000..
Polyamide-ethyleneimine-epichlorohydrin
resin (CAS Reg. No. 115340-77-7),
prepared by reacting equimolar amounts
of adipic acid and N-(2-aminoethyl)-
1,2-ethanediamine to form a basic
polyamidoamine which is modified by
reaction with ethyleneimine, and
further reacted with formic acid and
(chloromethyl)oxirane-[alpha]-hydro-
omega-hydroxypoly(oxy-1,2-ethanediyl)..
[[Page 220]]
Polybutene, hydrogenated; complying
with the identity prescribed under
Sec. 178.3740(b) of this chapter..
Poly [2-(diethylamino) ethyl
methacrylate] phosphate..
Polyethylene glycol (200) dilaurate....
Polyethylene glycol monoisotridecyl For use only as a surfactant at
ether sulfate, sodium salt (CAS Reg. levels not to exceed 3 percent
No. 150413-26-6). in latex formulations used in
pigment binders for paper and
paperboard.
Polymers: Homopolymers and copolymers Basic polymer.
of the following monomers:
Acrylamide.
Acrylic acid and its methyl, ethyl,
butyl, propyl, or octyl esters.
Acrylonitrile.
Butadiene.
Crotonic acid.
Cyclol acrylate.
Decyl acrylate.
Diallyl fumarate.
Diallyl maleate.
Diallyl phthalate.
Dibutyl fumarate.
Dibutyl itaconate.
Dibutyl maleate.
Di(2-ethylhexyl) maleate.
Dioctyl fumarate.
Dioctyl maleate.
Divinylbenzene.
Ethylene.
2-Ethylhexyl acrylate.
Fumaric acid.
Glycidyl methacrylate.
2-Hydroxyethyl acrylate.
N-(Hydroxymethyl) acrylamide.
Isobutyl acrylate.
Isobutylene.
Isoprene.
Itaconic acid.
Maleic anhydride and its methyl or
butyl esters.
Methacrylic acid and its methyl,
ethyl, butyl, or propyl esters.
Methylstyrene.
Mono(2-ethylhexyl) maleate.
Monoethyl maleate.
5-Norbornene-2,3-dicarboxylic acid,
mono-n-butyl ester.
Styrene.
Vinyl acetate.
Vinyl butyrate.
Vinyl chloride.
Vinyl crotonate.
Vinyl hexoate.
Vinylidene chloride.
Vinyl pelargonate.
Vinyl propionate.
Vinyl pyrrolidone.
Vinyl stearate.
Vinyl sulfonic acid.
Polymer prepared from urea, ethanedial, For use only as a starch and
formaldehyde, and propionaldehyde (CAS protein reactant in paper and
Reg. No. 106569-82-8). paperboard coatings.
Polyoxyethylene (minimum 12 moles)
ester of tall oil (30%-40% rosin
acids)..
Polyoxypropylene-polyoxyethylene glycol
(minimum molecular weight 1,900)..
Polyvinyl alcohol......................
Potassium titanate fibers produced by
calcining titanium dioxide, potassium
chloride, and potassium carbonate,
such that the finished crystalline
fibers have a nominal diameter of 0.20-
0.25 micron, a length-to-diameter
ratio of approximately 25:1 or
greater, and consist principally of
K2Ti4O9 and K2Ti 6O13..
Sodium diisobutylphenoxy diethoxyethyl
sulfonate..
Sodium diisobutylphenoxy monoethoxy
ethylsulfonate..
Sodium n-dodecylpolyethoxy (50 moles)
sulfate..
Sodium isododecylphenoxypolyethoxy (40
moles) sulfate..
Sodium N-methyl-N-oleyl taurate........
Sodium methyl siliconate...............
[[Page 221]]
Sodium nitrite.........................
Sodium polyacrylate....................
Sodium bis-tridecylsulfosuccinate......
Sodium xylene sulfonate................
Stearato chromic chloride complex......
Styrene-allyl alcohol copolymers.......
Styrene-methacrylic acid copolymer,
potassium salt..
Tetraethylenepentamine................. Polymerization cross-linking
agent.
[alpha]-[p-(1,1,3,3-
Tetramethylbutyl)phenyl]-omega
hydroxypoly(oxyethylene) mixture of
dihydrogen phosphate and monohydrogen
phosphate esters and their sodium,
potassium, and ammonium salts having a
poly(oxyethylene) content averaging 6-
9 or 40 moles..
[alpha]-[p-(1,1,3,3-
Tetramethylbutyl)phenyl or p-
nonylphenyl]-omega-hydroxypoly
(oxyethylene) where nonyl group is a
propylene trimer isomer..
Tetrasodium N-(1,2-dicarboxyethyl)-N-
octadecyl sulfosuccinamate..
Toluene................................
Triethanolamine........................
Triethylenetetramine................... Polymerization cross-linking
agent.
Triethylenetetramine monoacetate,
partially stearoylated..
Urea-formaldehyde chemically modified
with:
Alcohol (methyl, ethyl, butyl,
isobutyl, propyl, or isopropyl).
Aminomethylsulfonic acid.
Diaminobutane.
Diaminopropane.
Diethylenetriamine.
N,N'-Dioleoylethylenediamine.
Diphenylamine.
N,N'-Distearoylethylenediamine.
Ethylenediamine.
Guanidine.
Imino-bis-butylamine.
Imino-bis-ethylamine.
Imino-bis-propylamine.
N-Oleoyl-N'-stearoylethylenediamine.
Polyamines made by reacting
ethylenediamine or triethylenediamine
with dichloroethane or
dichloropropane.
Tetraethylenepentamine.
Triethylenetetramine.
Xylene.................................
Xylene sulfonic acid-formaldehyde
condensate, sodium salt..
Zinc stearate..........................
------------------------------------------------------------------------
[42 FR 14554, Mar. 15, 1977]
Editorial Note: For additional Federal Register citations affecting
Sec. 176.180, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.200]
[Page 221-223]
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. 176.200 Defoaming agents used in coatings.
The defoaming agents described in this section may be safely used as
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section.
(a) The defoaming agents are prepared as mixtures of substances
described in paragraph (d) of this section.
(b) The quantity of any substance employed in the formulation of
defoaming agents does not exceed the amount reasonably required to
accomplish the intended physical or technical effect in the defoaming
agents or any limitation further provided.
(c) Any substance employed in the production of defoaming agents and
which is the subject of a regulation in parts 174, 175, 176, 177, 178
and Sec. 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the formulation of defoaming agents
include:
(1) Substances generally recognized as safe in food.
[[Page 222]]
(2) Substances subject to prior sanction or approval for use in
defoaming agents and used in accordance with such sanction or approval.
(3) Substances identified in this paragraph (d)(3) and subject to
such limitations as are provided:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
n-Butyl alcohol........................
tert-Butyl alcohol.....................
Butyl stearate.........................
Castor oil, sulfated, ammonium,
potassium, or sodium salt.
Cetyl alcohol..........................
Cyclohexane............................
Cyclohexanol...........................
Diethylene glycol monolaurate..........
Diethylene glycol monostearate.........
Dimers and trimers of unsaturated C18 For use only at levels not to
fatty acids derived from: exceed 0.1% by weight of total
coating solids.
Animal and vegetable fats and oils.
Tall oil.
Dimethylpolysiloxane...................
[alpha]-(Dinonylphenyl)-[omega]-hydroxy- For use only in defoaming
poly(oxy-1,2-ethanediyl), containing 7 agents for the production of
to 24 moles of ethylene oxide per mole styrene-butadiene coatings at
of dinonylphenol (CAS Reg. No. 9014-93- a level not to exceed 0.05
1). percent by weight of the
finished coating.
Dipropylene glycol.....................
Ethyl alcohol..........................
Fats and oils derived from animal,
marine, or vegetable sources:
Fatty acids derived from animal,
marine, or vegetable fats and
oils, and salts of such acids,
single or mixed, as follows:
Aluminum.......................
Ammonium.......................
Calcium........................
Magnesium......................
Potassium......................
Sodium.........................
Zinc...........................
Formaldehyde........................... For use as preservative of
defoamer only.
Glyceryl mono-12-hydroxystearate.......
Glyceryl monostearate..................
Hexane.................................
Hexylene glycol (2-methyl-2,4-
pentanediol).
Isobutyl alcohol.......................
Isopropyl alcohol......................
Kerosene...............................
Lecithin hydroxylated..................
Methyl alcohol.........................
Methylcellulose........................
Methyl esters of fatty acids derived
from animal, marine, or vegetable fats
and oils.
Methyl oleate..........................
Methyl palmitate.......................
Mineral oil............................
Mustardseed oil, sulfated, ammonium,
potassium, or sodium salt.
Myristyl alcohol.......................
Naphtha................................
[beta]-Naphthol........................ For use as preservative of
defoamer only.
Nonylphenol............................
Odorless light petroleum hydrocarbons.. As defined in Sec. 178.3650 of
this chapter.
Oleic acid, sulfated, ammonium,
potassium, or sodium salt.
Parachlorometacresol................... For use as preservative of
defoamer only.
Peanut oil, sulfated, ammonium,
potassium, or sodium salt.
Petrolatum.............................
Pine oil...............................
Polyacrylic acid, sodium salt.......... As a stabilizer and thickener
in defoaming agents containing
dimethylpolysiloxane.
Polyethylene...........................
Polyethylene, oxidized.................
Polyethylene glycol (200) dilaurate....
Polyethylene glycol (400) dioleate.....
Polyethylene glycol (600) dioleate.....
Polyethylene glycol (400) esters of
coconut oil fatty acids.
Polyethylene glycol (400) monooleate...
[[Page 223]]
Polyethylene glycol (600) monooleate...
Polyethylene glycol (600)
monoricinoleate.
Polyethylene glycol (400) monostearate.
Polyoxybutylene-polyoxypropylene-
polyoxyethylene glycol (min. mol. wt.
3,700).
Polyoxyethylated (min. 3 mols) cetyl
alcohol.
Polyoxyethylated (min. 5 mols) oleyl
alcohol.
Polyoxyethylated (min. 1.5 mols)
tridecyl alcohol.
Polyoxyethylene (min. 15 mols) ester of
rosin.
Polyoxyethylene (min. 8 mols)
monooleate.
Polyoxyethylene (40) stearate..........
Polyoxypropylated (min. 20 mols) butyl
alcohol.
Polyoxypropylene glycol (min. mol. wt.
200).
Polyoxypropylene (min. 20 mols) oleate
butyl ether.
Polyoxypropylene-polyoxyethylene glycol
(min. mol. wt. 1,900).
Polyoxypropylene (min. 40 mols)
stearate butyl ether.
Potassium pentachlorophenate........... For use as preservative of
defoamer only.
Potassium trichlorophenate............. Do.
Propylene glycol monoester of soybean
oil fatty acids.
Propylene glycol monoester of tallow
fatty acids.
Ricebran oil, sulfated, ammonium,
potassium, or sodium salt.
Rosins and rosin derivatives........... As provided in Sec. 178.3870
of this chapter.
Silica.................................
Sodium 2-mercaptobenzothiazole......... For use as preservative of
defoamer only.
Sodium pentachlorophenate.............. Do.
Sodium trichlorophenate................ Do.
Sperm oil, sulfated, ammonium,
potassium, or sodium salt.
Stearyl alcohol........................
Tall oil fatty acids...................
Tallow fatty acids, hydrogenated or
sulfated.
Tallow, sulfated, ammonium, potassium,
or sodium salt.
Triethanolamine........................
Triisopropanolamine....................
Waxes, petroleum.......................
------------------------------------------------------------------------
(e) The defoaming agents are used as follows:
(1) The quantity of defoaming agent or agents used shall not exceed
the amount reasonably required to accomplish the intended effect, which
is to prevent or control the formation of foam.
(2) The defoaming agents are used in the preparation and application
of coatings for paper and paperboard.
[42 FR 14554, Mar. 15, 1977, as amended at 62 FR 39772, July 24, 1997]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.210]
[Page 223-225]
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. 176.210 Defoaming agents used in the manufacture of paper and paperboard.
Defoaming agents may be safely used in the manufacture of paper and
paperboard intended for use in packaging, transporting, or holding food
in accordance with the following prescribed conditions:
(a) The defoaming agents are prepared from one or more of the
substances named in paragraph (d) of this section, subject to any
prescribed limitations.
(b) The defoaming agents are used to prevent or control the
formation of foam during the manufacture of paper and paperboard prior
to and during the sheet-forming process.
(c) The quantity of defoaming agent or agents added during the
manufacturing process shall not exceed the amount necessary to
accomplish the intended technical effect.
(d) Substances permitted to be used in the formulation of defoaming
agents include substances subject to prior sanctions or approval for
such use and employed subject to the conditions of such sanctions or
approvals, substances generally recognized as safe for use in food,
substances generally recognized as safe for use in paper and paperboard,
and substances listed in this paragraph, subject to the limitations, if
any, prescribed.
(1) Fatty triglycerides, and the fatty acids, alcohols, and dimers
derived therefrom:
Beef tallow.
Castor oil.
Coconut oil.
[[Page 224]]
Corn oil.
Cottonseed oil.
Fish oil.
Lard oil.
Linseed oil.
Mustardseed oil.
Palm oil.
Peanut oil.
Rapeseed oil.
Ricebran oil.
Soybean oil.
Sperm oil.
Tall oil.
(2) Fatty triglycerides, and marine oils, and the fatty acids and
alcohols derived therefrom (paragraph (d)(1) of this section) reacted
with one or more of the following, with or without dehydration, to form
chemicals of the category indicated in parentheses:
Aluminum hydroxide (soaps).
Ammonia (amides).
Butanol (esters).
Butoxy-polyoxypropylene, molecular weight 1,000-2,500 (esters).
Butylene glycol (esters).
Calcium hydroxide (soaps).
Diethanolamine (amides).
Diethylene glycol (esters).
Ethylene glycol (esters).
Ethylene oxide (esters and ethers).
Glycerin (mono- and diglycerides).
Hydrogen (hydrogenated compounds).
Hydrogen (amines).
Isobutanol (esters).
Isopropanol (esters).
Magnesium hydroxide (soaps).
Methanol (esters).
Morpholine (soaps).
Oxygen (air-blown oils).
Pentaerythritol (esters).
Polyoxyethylene, molecular weights 200, 300, 400, 600, 700, 1,000,
1,540, 1,580, 1,760, 4,600 (esters).
Polyoxypropylene, molecular weight 200-2,000 (esters).
Potassium hydroxide (soaps).
Propanol (esters).
Propylene glycol (esters).
Propylene oxide (esters).
Sodium hydroxide (soaps).
Sorbitol (esters).
Sulfuric acid (sulfated and sulfonated compounds).
Triethanolamine (amides and soaps).
Triisopropanolamine (amides and soaps).
Trimethylolethane (esters).
Zinc hydroxide (soaps).
(3) Miscellaneous:
Alcohols and ketone alcohols mixture (still-bottom product from
C12-C18 alcohol manufacturing process).
Amyl alcohol.
Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.
Butoxy-polyoxypropylene molecular weight 1,000-2,500.
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Calcium lignin sulfonate.
Capryl alcohol.
p-Chlorometacresol.
Cyclohexanol.
Diacetyltartaric acid ester of tallow mono-glyceride.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691-65-7), for use as a
preservative at a level not to exceed 0.05 weight-percent of the
defoaming agent.
Diethanolamine.
Diethylene triamine.
Di-(2-ethylhexyl) phthalate.
2,6-Dimethyl heptanol-4 (nonyl alcohol).
Dimethylpolysiloxane.
Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Ethanol.
2-Ethylhexanol.
Ethylenediamine tetraacetic acid tetrasodium salt.
Formaldehyde.
Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol
manufacture, of approximate composition: Octyl alcohol 5 percent nonyl
alcohol 10 percent, decyl and higher alcohols 35 percent, esters 45
percent, and soaps 5 percent).
2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-oxazoline.
Hexylene glycol (2-methyl-2-4-pentanediol).
12-Hydroxystearic acid.
Isobutanol.
Isopropanol.
Isopropylamine salt of dodecylbenzene sulfonic acid.
Kerosine.
Lanolin.
Methanol.
Methyl 12-hydroxystearate.
Methyl taurine-oleic acid condensate, molecular weight 486.
a,a'-[Methylenebis[4-(1,1,3,3-tetramethylbu-tyl)-o-phenylene]]bis[omega-
hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per
hydroxyl group.
Mineral oil.
Mono-, di-, and triisopropanolamine.
Mono- and diisopropanolamine stearate.
Monobutyl ether of ethylene glycol.
Monoethanolamine.
Morpholine.
Myristyl alcohol.
Naphtha.
[beta]-Naphthol.
Nonylphenol.
Odorless light petroleum hydrocarbons.
Oleyl alcohol.
Petrolatum.
o-Phenylphenol.
Pine oil.
[[Page 225]]
Polybutene, hydrogenated; complying with the identity prescribed under
Sec. 178.3740(b) of this chapter.
Polyethylene.
Polyethylene, oxidized (air-blown).
Polymer derived from N-vinyl pyrrolidone and copolymers derived from the
mixed alkyl (C12-C15, C16,
C18, C20, and C22) methacrylate esters,
butyl methacrylate (CAS Reg. No. 97-88-1), isobutyl methacrylate (CAS
Reg. No. 97-86-9) and methyl methacrylate (CAS Reg. No. 80-62-6); the
combined polymer contains no more than 5 weight percent of polymer units
derived from N-vinyl pyrrolidone and is present at a level not to exceed
7 parts per million by weight of the finished dry paper and paperboard
fibers.
Polyoxyethylene (4 mols) decyl phosphate.
Polyoxyethylene (4 mols) di(2-ethyl hexanoate).
Polyoxyethylene (15 mols) ester of rosin.
Polyoxyethylene (3-15 mols) tridecyl alcohol.
Polyoxypropylene, molecular weight 200-2,000.
Polyoxypropylene-polyoxethylene condensate, minimum molecular weight
950.
Polyoxypropylene-ethylene oxide condensate of ethylene diamine,
molecular weight 1,700-3,800.
Polyvinyl pyrrolidone, molecular weight 40,000.
Potassium distearyl phosphate.
Potassium pentachlorophenate.
Potassium trichlorophenate.
Rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this
chapter.
Silica.
Siloxanes and silicones, dimethyl, methylhydrogen, reaction products
with polyethylene-polypropylene glycol monoallyl ether (CAS Reg. No.
71965-38-3).
Sodium alkyl (C9-C15) benzene-sulfonate.
Sodium dioctyl sulfosuccinate.
Sodium distearyl phosphate.
Sodium lauryl sulfate.
Sodium lignin sulfonate.
Sodium 2-mercaptobenzothiazole.
Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde (2
mols).
Sodium orthophenylphenate.
Sodium pentachlorophenate.
Sodium petroleum sulfonate, molecular weight 440-450.
Sodium trichlorophenate.
Stearyl alcohol.
[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-nonylphenyl-, or p-
dodecylphenyl]-omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of p-alkylphenol (alkyl group is 1,1,3,3-
tetramethylbutyl, a propylene trimer isomer, or a propylene tetramer
isomer) with an average of 1.5-15 moles of ethylene oxide.
Tetrahydrofurfuryl alcohol.
Tributoxyethyl phosphate.
Tributyl phosphate.
Tridecyl alcohol.
Triethanolamine.
Triethylene glycol di(2-ethyl hexanoate).
Tri-(2-ethylhexyl) phosphate.
Tristearyl phosphate.
Wax, petroleum, Type I and Type II.
Wax, petroleum (oxidized).
Wax (montan).
[42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27, 1982;
47 FR 46495, Oct. 19, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897,
June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR 14246, Apr. 1, 1996]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.230]
[Page 225]
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. 176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-2-thione may safely be
used as a preservative in the manufacture and coating of paper and
paperboard intended for use in contact with food in accordance with the
following prescribed conditions:
(a) It is used as follows:
(1) In the manufacture of paper and paperboard as a preservative for
substances added to the pulp suspension prior to the sheet-forming
operation provided that the preservative is volatilized by heat in the
drying and finishing of the paper and paperboard.
(2) As a preservative for coatings for paper and paperboard,
Provided, That the preservative is volatilized by heat in the drying and
finishing of the coated paper or paperboard.
(b) The quantity used shall not exceed the least amount reasonably
required to accomplish the intended technical effect and shall not be
intended to nor, in fact, accomplish any physical or technical effect in
the food itself.
(c) The use of a preservative in any substance or article subject to
any regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter must comply with any specifications and limitations prescribed
by such regulation for the substance or article.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.250]
[Page 225-226]
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. 176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
Poly-1,4,7,10,13-pentaaza-15-hydrox-yhexadecane may be safely used
as a retention aid employed prior to the sheet-forming operation in the
manufacture of paper and paperboard intended for use in contact with
food in
[[Page 226]]
an amount not to exceed that necessary to accomplish the intended
physical or technical effect and not to exceed 6 pounds per ton of
finished paper or paperboard.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.260]
[Page 226]
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. 176.260 Pulp from reclaimed fiber.
(a) Pulp from reclaimed fiber may be safely used as a component of
articles used in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of paragraph (b) of this section.
(b) Pulp from reclaimed fiber is prepared from the paper and
paperboard products described in paragraphs (b) (1) and (2) of this
section, by repulping with water to recover the fiber with the least
possible amount of nonfibrous substances.
(1) Industrial waste from the manufacture of paper and paperboard
products excluding that which bears or contains any poisonous or
deleterious substance which is retained in the recovered pulp and that
migrates to the food, except as provided in regulations promulgated
under sections 406 and 409 of the Federal Food, Drug, and Cosmetic Act.
(2) Salvage from used paper and paperboard excluding that which (i)
bears or contains any poisonous or deleterious substance which is
retained in the recovered pulp and that migrates to the food, except as
provided in regulations promulgated under sections 406 and 409 of the
act or (ii) has been used for shipping or handling any such substance.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.300]
[Page 226-227]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table of Contents
Subpart B--Substances for Use Only as Components of Paper and Paperboard
Sec. 176.300 Slimicides.
(a) Slimicides may be safely used in the manufacture of paper and
paperboard that contact food, in accordance with the following
prescribed conditions:
(1) Slimicides are used as antimicrobial agents to control slime in
the manufacture of paper and paperboard.
(2) Subject to any prescribed limitations, slimicides are prepared
from one or more of the slime-control substances named in paragraph (c)
of this section to which may be added optional adjuvant substances as
provided for under paragraph (d) of this section.
(3) Slimicides are added to the process water used in the production
of paper or paperboard, and the quantity added shall not exceed the
amount necessary to accomplish the intended technical effect.
(b) To insure safe usage, the label or labeling of slimicides shall
bear adequate directions for use.
(c) Slime-control substances permitted for use in the preparation of
slimicides include substances subject to prior sanction or approval for
such use and the following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Acrolein...............................
Alkenyl (C16-C18) dimethylethyl-
ammonium bromide.
n-Alkyl (C12-C18) dimethyl benzyl
ammonium chloride.
1,2-Benzisothiazolin-3-one............. At a level of 0.06 pound per
ton of dry weight fiber.
Bis(1,4-bromoacetoxy)-2-butene.........
5,5-Bis(bromoacetoxymethyl) m-dioxane..
2,6-Bis(dimethylaminomethyl)
cyclohexanone.
1,2-Bis(monobromoacetoxy) ethane [CA At a maximum level of 0.10
Reg. No. 3785-34-0]. pound per ton of dry weight
fiber.
Bis(trichloromethyl)sulfone............
4-Bromoacetoxymethyl-m-dioxolane.......
2-Bromo-4'-hydroxyacetophenone.........
2-Bromo-2-nitropropane-1,3-diol (CAS At a maximum level of 0.6 pound
Reg. No. 52-51-7). per ton of dry weight fiber.
[beta]-Bromo-[beta]-nitrostyrene....... At a maximum level of 1 pound
per ton of dry weight fiber.
Chloroethylenebisthiocyanate...........
5-Chloro-2 - methyl - 4 - isothiazolin- At a level of 2.5 pounds per
3-one calcium chloride and 2-methyl-4- ton of dry weight fiber.
isothiazolin-3-one calcium chloride
mixture at a ratio of 3 parts to 1
part.
Chlorinated levulinic acids............
Chloromethyl butanethiolsulfonate......
Cupric nitrate.........................
n-Dialkyl (C12-C18)
benzylmethylammonium chloride.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. At a maximum level of 0.005% of
No. 35691-65-7). dry weight fiber.
2,2-Dibromo-3-nitrilopropionamide...... At a maximum level of 0.1 lb/
ton of dry weight fiber.
2,3-Dibromopropionaldehyde.............
4,5-dichloro-1, 2-dithiol-3-one (CAS For use only at levels not to
Reg. No. 1192-52-5). exceed 10 milligrams per
kilogram in the pulp slurry.
[[Page 227]]
1,3-Dihalo-5,5-dimethylhydantoin (where At a maximum level of 1.0
the dihalo (halogen) may be bromine kilogram (kg) per 1,000 kg of
and/or chlorine) that may contain no dry weight fiber.
more than 20 weight percent 1,3-dihalo-
5-ethyl-5-methylhydantoin (where the
dihalo (halogen) may be bromine and/or
chlorine)..
4-(Diiodomethylsulfonyl) toluene (CAS At a maximum level of 0.2 pound
Reg. No. 20018-09-01).. per ton (100 grams/1,000
kilograms) of dry weight
fiber.
3,5-Dimethyl 1,3,5,2H-
tetrahydrothiadiazine-2-thione.
Dipotassium and disodium
ethylenebis(dithiocarba-mate).
Disodium cyanodithioimidocarbonate.....
n-Dodecylguanidine hydrochloride....... At a maximum level of 0.20
pound per ton of dry weight
fiber.
Glutaraldehyde (CAS Reg. No. 111-30-8).
2-(p-hydroxyphenyl) glyoxylohydroximoyl At a level of 0.02 pound per
chloride (CAS Registry No. 34911-46-1). ton of dry weight fiber.
2-Hydroxypropyl methanethiol sulfonate.
2-Mercaptobenzothiazole................
Methylenebisbutanethiolsulfonate.......
Methylenebisthiocyanate................
2-Nitrobutyl bromoacetate [CA Reg. No. At a maximum level of 0.15
32815-96-6]. pound per ton of dry weight
fiber.
N-[[alpha]-(Nitroethyl)benzyl]
ethylenediamine.
Potassium 2-mercaptobenzothiazole......
Potassium N-hydroxymethyl-N-
methyldithiocarba-mate.
Potassium N-methyldithiocarbamate......
Potassium pentachlorophenate...........
Potassium trichlorophenate.............
Silver fluoride........................ Limit of addition to process
water not to exceed 0.024
pound, calculated as silver
fluoride, per ton of paper
produced.
Silver nitrate.........................
Sodium dimethyldithiocarbamate.........
Sodium 2-mercaptobenzothiazole.........
Sodium pentachlorophenate..............
Sodium trichlorophenate................
1,3,6,8-Tetraazatricyclo[6.2.1.13,6]
dodecane.
3,3,4,4-Tetrachlorotetrahydrothiophene-
1,1-dioxide.
Tetrakis(hydroxymethyl)phosphonium Maximum use level of 84 mg/kg
sulfate (CAS Reg. No. 55566-30-8). in the pulp slurry. The
additive may also be added to
water, which when introduced
into the pulp slurry, results
in a concentration in the pulp
slurry not to exceed 84 mg/kg.
2-(Thiocyanomethylthio) benzothiazole..
Vinylene bisthiocyanate................
------------------------------------------------------------------------
(d) Adjuvant substances permitted to be used in the preparation of
slimicides include substances generally recognized as safe for use in
food, substances generally recognized as safe for use in paper and
paperboard, substances permitted to be used in paper and paperboard by
other regulations in this chapter, and the following:
Acetone.
Butlylene oxide.
Dibutyl phthalate.
Didecyl phthalate.
N,N-Dimethylformamide.
Dodecyl phthalate.
Ethanolamine.
Ethylene glycol.
Ethylenediamine.
N-methyl-2-pyrrolidone (CAS Reg. No. 872-50-4).
a,a'-[Methylenebis[4-(1,1,3,3-tetramethylbutyl)-o-phenylene]] bis[omega-
hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per
hydroxyl group.
Monomethyl ethers of mono-, di-, and tripropylene glycol.
Nonylphenol reaction product with 9 to 12 molecules of ethylene oxide.
Octylphenol reaction product with 25 molecules of propylene oxide and 40
molecules of ethylene oxide.
[42 FR 14554, Mar. 15, 1977, as amended at 42 FR 41854, Aug. 19, 1977;
44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR 5748, Feb.
15, 1984; 51 FR 19059, May 27, 1986; 51 FR 43734, Dec. 4, 1986; 54 FR
18103, Apr. 27, 1989; 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24,
1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497, June 30, 2000; 65 FR
70790, Nov. 28, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.320]
[Page 227-228]
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. 176.320 Sodium nitrate-urea complex.
Sodium nitrate-urea complex may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
[[Page 228]]
(a) Sodium nitrate-urea complex is a clathrate of approximately two
parts urea and one part sodium nitrate.
(b) Sodium nitrate-urea complex conforming to the limitations
prescribed in paragraph (b)(1) of this section is used as provided in
paragraph (b)(2) of this section.
(1) Limitations. (i) It is used as a plasticizer in glassine and
greaseproof paper.
(ii) The amount used does not exceed that required to accomplish its
intended technical effect or exceed 15 percent by weight of the finished
paper.
(2) Conditions of use. The glassine and greaseproof papers are used
for packaging dry food or as the food-contact surface for dry food.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR176.350]
[Page 228]
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. 176.350 Tamarind seed kernel powder.
Tamarind seed kernel powder may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) Tamarind seed kernel powder is the ground kernel of tamarind
seed (Tamarindus indica L.) after removal of the seed coat.
(b) It is used in the manufacture of paper and paperboard.
