[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1520]
[Page 269-284]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1520 Olefin polymers.
The olefin polymers listed in paragraph (a) of this section may be
safely used as articles or components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, olefin polymers are basic
polymers manufactured as described in this paragraph, so as to meet the
specifications prescribed in paragraph (c) of this section, when tested
by the methods described in paragraph (d) of this section.
(1)(i) Polypropylene consists of basic polymers manufactured by the
catalytic polymerization of propylene.
(ii) Propylene homopolymer consists of basic polymers manufactured
by the catalytic polymerization of propylene with a metallocene
catalyst.
(2)(i) Polyethylene consists of basic polymers manufactured by the
catalytic polymerization of ethylene.
(ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6)
consists of basic polymers manufactured by the catalytic polymerization
of ethylene followed by reaction with fumaric acid in the absence of
free radical initiators. Such polymers shall contain grafted fumaric
acid at levels
[[Page 270]]
not to exceed 2 percent by weight of the finished polymer.
(3) Olefin basic copolymers consist of basic copolymers manufactured
by the catalytic copolymerization of:
(i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such
olefin basic copolymers contain not less than 96 weight-percent of
polymer units derived from ethylene and/or propylene, except that:
(a)(1) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall
contain not less than 90 weight-percent of polymer units derived from
ethylene;
(2) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and hexene-1 shall contain not less than 80
but not more than 90 weight percent of polymer units derived from
ethylene.
(3) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and pentene-1 shall contain not less than
90 weight-percent of polymer units derived from ethylene.
(4) Olefin basic copolymers manufactured by the catalytic
polymerization of ethylene and octene-1 shall contain not less than 50
weight-percent of polymer units derived from ethylene.
(b) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and 4-methylpentene-1 shall contain not
less than 89 weight-percent of polymer units derived from ethylene;
(c)(1) Olefin basic copolymers manufactured by the catalytic
copolymerization of two or more of the monomers ethylene, propylene,
butene-1, 2-methylpropene-1, and 2,4,4-trimethylpentene-1 shall contain
not less than 85 weight-percent of polymer units derived from ethylene
and/or propylene;
(2) Olefin basic copolymers manufactured by the catalytic
copolymerization of propylene and butene-1 shall contain greater than 15
but not greater than 35 weight percent of polymer units derived from
butene-1 with the remainder being propylene.
(d) Olefin basic terpolymers manufactured by the catalytic
copolymerization of ethylene, hexene-1, and either propylene or butene-
1, shall contain not less than 85 weight percent polymer units derived
from ethylene.
(e) Olefin basic copolymers manufactured by the catalytic
polymerization of ethylene and octene-1, or ethylene, octene-1, and
either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall contain
not less than 80 weight percent of polymer units derived from ethylene.
(ii) 4-Methylpentene-1 and 1-alkenes having from 6 to 18 carbon
atoms. Such olefin basic copolymers shall contain not less than 95 molar
percent of polymer units derived from 4-methylpentene-1, except that
copolymers manufactured with 1-alkenes having from 12 to 18 carbon atoms
shall contain not less than 97 molar percent of polymer units derived
from 4-methylpentene-1; or
(iii) Ethylene and propylene that may contain as modifiers not more
than 5 weight-percent of total polymer units derived by copolymerization
with one or more of the following monomers:
5-Ethylidine-2-norbornene.
5-Methylene-2-norbornene.
(iv) Ethylene and propylene that may contain as a modifier not more
than 4.5 weight percent of total polymer units derived by
copolymerization with 1,4-hexadiene.
(v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087-34-7) that
shall contain not less than 80 weight percent of polymer units derived
from ethylene.
(vi) Olefin basic copolymers (CAS Reg. No. 61615-63-2) manufactured
by the catalytic copolymerization of ethylene and propylene with 1,4-
hexadiene, followed by reaction with fumaric acid in the absence of free
radical initiators. Such polymers shall contain not more than 4.5
percent of polymer units deriving from 1,4-hexadiene by weight of total
polymer prior to reaction with fumaric acid and not more than 2.2
percent of grafted fumaric acid by weight of the finished polymer.
(vii) Ethylene and 2-norbornene (CAS Reg. No. 26007-43-2) copolymers
that shall contain not less than 30 and not
[[Page 271]]
more than 70 mole percent of polymer units derived from 2-norbornene.
(4) Poly(methylpentene) consists of basic polymers manufactured by
the catalytic polymerization of 4-methylpentene-1.
(5) Polyethylene graft copolymers consist of polyethylene complying
with item 2.2 of paragraph (c) of this section which subsequently has
3a,4,7,7a-tetrahydromethyl-4,7-methanoisobenzofuran-1,3-dione grafted
onto it at a level not to exceed 1.7 percent by weight of the finished
copolymer.
(6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2)
containing no more than 2 percent by weight of copolymer units derived
from maleic anhydride.
(b) The basic olefin polymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic olefin polymers. The optional adjuvant
substances required in the production of the basic olefin polymers or
finished food-contact articles may include substances permitted for such
use by applicable regulations in parts 170 through 189 of this chapter,
substances generally recognized as safe in food and food packaging,
substances used in accordance with a prior sanction or approval, and the
following:
------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
Aromatic petroleum hydrocarbon resin, For use only as an adjuvant at
hydrogenated (CAS Reg. No. 88526-47- levels not to exceed 25
0), produced by the catalytic percent by weight in blends
polymerization of aromatic-substituted with polypropylene complying
olefins from distillates of cracked with paragraph (c), item 1.1
petroleum stocks with a boiling point of this section. The finished
no greater than 220 deg.C (428 polymer may be used in contact
deg.F), and the subsequent catalytic with food Types I, II, IV-B,
hydrogenation of the resulting VI-A through VI-C, VII-B, and
aromatic petroleum hydrocarbon resin, VIII identified in table 1 of
having a minimum softening point of Sec. 176.170(c) of this
110 deg.C (230 deg.F), as determined chapter and under conditions
by ASTM Method E 28-67 (Reapproved of use B through H described
1982), ``Standard Test Method for in table 2 of Sec. 176.170(c)
Softening Point by Ring-and-Ball of this chapter; and with food
Apparatus,'' and a minimum aniline Types III, IV-A, V, VII-A, and
point of 107 deg.C (225 deg.F), as IX identified in table 1 of
determined by ASTM Method D 611-82, Sec. 176.170(c) of this
``Standard Test Methods for Aniline chapter and under conditions
Point and Mixed Aniline Point of of use D through G described
Petroleum Products and Hydrocarbon in table 2 of Sec. 176.170(c)
Solvents,'' both of which are of this chapter.
incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from
the American Society for Testing and
Materials, 1916 Race St.,
Philadelphia, PA 19103, or from the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 200 C St. SW.,
Washington, DC 20204, or may be
examined at the Office of the Federal
Register, 800 North Capitol St. NW.,
suite 700, Washington, DC.
Colorants used in accordance with Sec.
178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert- For use as an initiator in the
butylperoxy)hexane (CAS Reg. No. 78-63- production of propylene
7). homopolymer complying with
Sec. 177.1520(c), item 1.1
and olefin copolymers
complying with Sec.
177.1520(c), items 3.1 and 3.2
and containing not less than
75 weight percent of polymer
units derived from propylene,
provided that the maximum
concentration of tert-butyl
alcohol in the polymer does
not exceed 100 parts per
million, as determined by a
method titled ``Determination
of tert-Butyl Alcohol in
Polypropylene,'' which is
incorporated by reference.
Copies are available from the
Center for Food Safety and
Applied Nutrition (HFS-200),
Food and Drug Administration,
200 C St. SW., Washington, DC
20204, or available for
inspection at the Office of
the Federal Register, 800
North Capitol Street, NW.,
suite 700, Washington, DC
20408.
[[Page 272]]
Methyl methacrylate/butyl acrylate- For use only at levels not to
grafted polypropylene copolymer exceed 6 percent by weight of
containing methyl methacrylate/butyl olefin polymers complying with
acrylate-grafted polypropylene (CAS paragraph (c) of this section,
Reg. No. 121510-09-6), methyl items 1.1, 3.1a, 3.2a, and
methacrylate/butyl acrylate copolymer 3.2b, where the copolymers
(CAS Reg. No. 25852-37-3), methyl complying with items 3.1a,
methacrylate homopolymer (CAS Reg. No. 3.2a, and 3.2b contain not
9011-14-7), and polypropylene (CAS less than 85 weight-percent of
Reg. No. 9003-07-0), resulting from polymer units derived from
the reaction of a mixture of methyl propylene.
methacrylate and butyl acrylate with
polypropylene. The finished product
contains no more than 55 percent by
weight of polymer units derived from
methyl methacrylate and butyl acrylate
as determined by a method entitled,
``Determination of the Total Acrylic
in PP-MMA/BA Polymers,'' which is
incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from
the Office of Premarket Approval,
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 200 C St. SW.,
Washington, DC 20204, or may be
examined at the Center for Food Safety
and Applied Nutrition's Library, 200
C. St. SW., rm. 3321, Washington, DC,
or at the Office of the Federal
Register, 800 North Capitol St. NW.,
suite 700, Washington, DC.
Petroleum hydrocarbon resins For use only as an adjuvant at
(cyclopentadiene-type), hydrogenated levels not to exceed 30
(CAS Reg. No. 68132-00-3) produced by percent by weight in blends
the thermal polymerization of with: (1) Polypropylene
dicyclopentadiene and cyclodiene complying with paragraph (c),
codimers (consisting of a mixture of item 1.1 of this section, or
cyclopentadiene, methyl (2) a copolymer of propylene
cyclopentadiene, and C4-C5 acyclic and ethylene containing not
dienes), followed by hydrogenation and less than 94 weight percent
having a ring-and-ball softening point propylene and complying with
of 119 deg.C minimum as determined by paragraph (c), item 3.2 of
ASTM Method E 28-67 (Reapproved 1982), this section. The average
``Standard Test Method for Softening thickness of the food-contact
Point by Ring-and-Ball Apparatus,'' film is not to exceed 0.1
and a minimum viscosity of 3,000 millimeter (0.004 inch). The
centipoise, measured at 160 deg.C, as finished polymer may be used
determined by ASTM Method D 3236-88, in contact with (1) Food types
``Standard Test Method for Apparent I, II, IV-B, VI-A, VI-B, VII-
Viscosity of Hot Melt Adhesives and B, and VIII identified in
Coating Materials,'' both of which are table 1 of Sec. 176.170(c) of
incorporated by reference in this chapter and under
accordance with 5 U.S.C. 552(a) and 1 conditions of use C through G
CFR part 51. Copies are available from described in table 2 of Sec.
the American Society for Testing and 176.170(c) of this chapter;
Materials, 1916 Race St., and (2) food types III, IV-A,
Philadelphia, PA 19103, or from the V, VI-C, VII-A, and IX
Center For Food Safety and Applied identified in table 1 of Sec.
Nutrition (HFS-200), Food and Drug 176.170(c) of this chapter and
Administration, 200 C St. SW., under conditions of use D
Washington, DC 20204, or may be through G described in table 2
examined at the Office of the Federal of Sec. 176.170(c) of this
Register, 800 North Capitol St. NW., chapter.
suite 700, Washington, DC.
Polymethylsilsesquioxane (CAS Reg. No. For use only as a surface
68554-70-1). lubricant or anti-blocking
agent in films.
Poly(vinylidene fluoride) homopolymer For use only as a processing
(CAS Reg. No. 24937-79-9), having a aid in the production of
melt viscosity of 6 to 37 kilopoise at olefin polymers complying with
a shear rate of 100-1 seconds at 232 paragraph (c) of this section
deg.C as determined by ASTM Method D at levels not to exceed 1.0
3835-79 (Reapproved 1983), ``Standard percent by weight of the
Test Method for Rheological Properties polymer. The finished polymers
of Thermoplastics with a Capillary may be used only under the
Rheometer'' using a capillary of 15:1 conditions described in Sec.
L/D, which is incorporated by 176.170(c) of this chapter,
reference in accordance with 5 U.S.C. table 2, under conditions of
552(a) and 1 CFR part 51. Copies are use B though H.
available from the Center for Food
Safety and Applied Nutrition (HFS-
200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204,
or may be examined at the Office of
the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC.
Polyoxyethylene-grafted For use as an extrusion aid in
polydimethylsiloxane (CAS Reg. No. the production of extruded
68937-54-2). olefin polymers that comply
with Sec. 177.1520(c) at
levels not to exceed 0.3
percent by weight of the
polymer. The finished polymer
is used in contact with foods
under conditions of use B
through H described in table 2
of Sec. 176.170 of this
chapter.
[[Page 273]]
Triisopropanolamine (CAS Reg. No. 122- For use as a Zeigler-Natta-type
20-3). catalyst deactivator and
antioxidant in the production
of olefin polymers complying
with Sec. 177.1520(c), items
2.1, 2.2, and 2.3, and having
a minimum density of 0.94
grams per cubic centimeter,
and copolymers complying with
Sec. 177.1520(c), items 3.1
and 3.2, for use in contact
with all foods under the
following conditions of use:
(a) films with a maximum
thickness of 0.102 millimeter
(0.004 inch) may be used under
conditions A through H defined
in table 2 of Sec. 176.170(c)
of this chapter; and (b)
articles with thickness
greater than 0.102 millimeter
(0.004 inch) may be used under
conditions C through G defined
in table 2 of Sec. 176.170(c)
of this chapter.
Trimethylpyridine and dimethylpyridine For use only as an adjuvant
mixture having percent by weight substance in the production of
composition as follows: 2,4,6- propylene homopolymers
trimethylpyridine (CAS Reg. No. 108-75- complying with items 1.1, 1.2,
8), not less than 60 percent; 2,3,6- and 1.3, and propylene
trimethylpyridine (CAS Reg. No. 1462- copolymers complying with
84-6), not more than 27 percent; 3,5- items 3.1, and 3.2 of
dimethylpyridine (CAS Reg. No. 591-22- paragraph (c) of this section
0), not more than 12 percent; and provided that the adjuvant is
other dimethylpyridines, not more than used at a level not to exceed
6 percent. 20 parts per million by weight
of the olefin polymers.
Vinylidene fluoride-hexafluoropropene For use only as an extrusion
copolymer (CAS Reg. No. 9011-17-0) aid in the production of
having a fluorine content of 65 to 71 extruded olefin polymers at
percent and a Mooney viscosity of at levels not to exceed 0.2
least 28, as determined by a method percent by weight of the
entitled ``Mooney Viscosity,'' which polymer. The finished polymers
is incorporated by reference in may be used only under the
accordance with 5 U.S.C. 552(a). conditions described in Sec.
Copies are available from the Center 176.170(c) of this chapter,
for Food Safety and Applied Nutrition table 2, under conditions of
(HFS-200), Food and Drug use B through H.
Administration, 200 C St. SW.,
Washington, DC 20204, or may be
examined at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC.
Vinylidene fluoride-hexafluoropropene For use only as a processing
copolymer (CAS Reg. No. 9011-17-0), aid in the production of
having a vinylidene fluoride content olefin polymers complying with
of not less than 87 percent but less paragraph (c) of this section
than 100 percent by weight and a melt at levels not to exceed 1.0
viscosity of 12 to 27 kilopoise at a percent by weight of the
shear rate of 100-1 seconds at 232 polymer. The finished polymers
deg.C as determined by ASTM Method D may be used only under the
3835-79 (Reapproved 1983), ``Standard conditions described in Sec.
Test Method for Rheological Properties 176.170(c) of this chapter,
of Thermoplastics with a Capillary table 2, under conditions of
Rheometer'' using a capillary of 15:1 use B though H.
L/D, which is incorporated by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are
available from the Center for Food
Safety and Applied Nutrition (HFS-
200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204,
or may be examined at the Office of
the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC 20408.
------------------------------------------------------------------------
(c) Specifications:
----------------------------------------------------------------------------------------------------------------
Maximum
extractable Maximum soluble
fraction fraction
Melting Point (MP) (expressed as (expressed as
or softening point percent by percent by weight
Olefin polymers Density (SP) (Degrees weight of the of polymer) in
Centigrade)- polymer) in N- xylene at
hexane at specified
specified temperatures
temperatures
----------------------------------------------------------------------------------------------------------------
1.1a. Polypropylene described in 0.880-0.913 MP: 160 deg.-180 6.4 pct at 9.8 pct at 25
paragraph (a)(1)(i) of this deg.C. reflux deg.C
section temperature
1.1b. Propylene homopolymer 0.880-0.913- MP: 150 deg.-180 6.4 pct at 9.8 pct at 25
described in paragraph (a)(1)(ii) deg.C. reflux deg.C
of this section temperature
1.2. Polypropylene, noncrystalline; 0.80-0.88
for use only to plasticize
polyethylene described under items
2.1 and 2.2 of this table, provided
that such plasticized polymers meet
the maximum extractable fraction
and maximum soluble fraction
specifications prescribed for such
basic polyethylene
[[Page 274]]
1.3. Polypropylene, noncrystalline, 0.80-0.88 SP:115 deg.-138
for use only: To plasticize deg.C.
polypropylene described by item 1.1
of this table, provided that such
plasticized polymers meet the
maximum extractable fraction and
maximum soluble fraction
specifications prescribed for such
basic polypropylene, and further
provided that such plasticized
polypropylene contacts food only of
the types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, IV-B, VI-B,
VII-B, and VIII; and for use at
levels not to exceed 50 pct by
weight of any mixture employed as a
food-contact coating provided such
coatings contact food only of the
types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, IV-B, VI-B,
VII-B, and VIII
2.1. Polyethylene for use in 0.85-1.00 .................. 5.5 pct at 50 11.3 pct at 25
articles that contact food except deg.C deg.C
for articles used for packing or
holding food during cooking
2.2. Polyethylene for use in 0.85-1.00 .................. 2.6 pct at 50 Do.
articles used for packing or deg.C
holding food during cooking
2.3. Polyethylene for use only as 0.85-1.00 .................. 53 pct at 50 75 pct at 25
component of food-contact coatings deg.C deg.C
at levels up to and including 50
percent by weight of any mixture
employed as a food-contact coating
2.4. Olefin polymers described in
paragraph (a)(2)(ii) of this
section, having a melt flow index
not to exceed 17 grams/per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, for use in blends
with other polymers at levels not
to exceed 20 percent by weight of
total polymer, subject to the
limitation that when contacting
food of types III, IV-A, V, VI-C,
VII-A, and IX identified in Sec.
176.170(c) of this chapter, Table
1, the polymers shall be used only
under conditions of use C, D, E, F,
and G, described in Sec.
176.170(c) of this chapter, Table
2.
3.1a. Olefin copolymers described in 0.85-1.00 .................. 5.5 pct at 50 30 pct at 25
paragraph (a)(3)(i) of this section deg.C deg.C
for use in articles that contact
food except for articles used for
packing or holding food during
cooking; except olefin copolymers
described in paragraph
(a)(3)(i)(a)(3) of this section and
listed in item 3.1c of this table
and olefin copolymers described in
paragraph (a)(3)(i)(e) of this
section and listed in item 3.1b of
this table
3.1b. Olefin copolymers described in 0.9-1.00 .................. Do Do.
paragraph (a)(3)(i)(e) of this
section for use in contact with
food only under conditions of use
D, E, F, G, and H described in Sec.
176.170(c) of this chapter, table
2
3.1c. Olefin copolymers described in Not less than
paragraph (a)(3)(i)(a)(3) of this 0.92
section for use in contact with
food only under conditions of use
B, C, D, E, F, G, and H described
in Sec. 176.170(c) of this
chapter, table 2; except that such
copolymers when used in contact
with food of the types identified
in Sec. 176.170(c), table 1, under
types III, IVA, V, VIIA, and IX,
shall be used only under conditions
of use D, E, F, and G described in
Sec. 176.170(c) of this chapter,
table 2
[[Page 275]]
3.2a. Olefin copolymers described in 0.85-1.00 .................. 2.6 pct at 50 Do.
paragraph (a)(3)(i) of this section deg.C
for use in articles used for
packing or holding food during
cooking; except olefin copolymers
described in paragraph
(a)(3)(i)(c)(2) of this section and
listed in item 3.2b of this table;
except that olefin copolymers
containing 89 to 95 percent
ethylene with the remainder being 4-
methyl-pentene-1 contacting food
Types III, IVA, V, VIIA, and IX
identified in Sec. 176.170(c) of
this chapter, table 1, shall not
exceed 0.051 millimeter (mm) (0.002
inch (in)) in thickness when used
under conditions of use A and shall
not exceed 0.102 mm (0.004 in) in
thickness when used under
conditions of use B, C, D, E, and H
described in Sec. 176.170(c) of
this chapter, table 2.
Additionally, olefin copolymers
described in (a)(3)(i)(a)(2) of
this section may be used only under
conditions of use B, C, D, E, F, G,
and H described in Sec. 176.170(c)
of this chapter, table 2, in
contact with all food types
identified in Sec. 176.170(c) of
this chapter, table 1
3.2b. Olefin copolymers described in Do.
paragraph (a)(3)(i)(c)(2) of this
section have a melt flow index no
greater than 10 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, and the thickness of
the finished polymer contacting
food shall not exceed 0.025 mm
(0.001 in). Additionally, optional
adjuvants permitted for use in
olefin copolymers complying with
item 3.2a of this table may be used
in the production of this copolymer
3.2c. Olefin copolymers described in 0.85-0.92 ................
paragraph (a)(3)(i)(a)(4) of this
section have a melt flow index no
greater than 50 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section. Articles manufactured
using these polymers may be used
with all types of food under
conditions of use C through H as
described in table 2 of Sec.
176.170(c) of this chapter
3.3a. Olefin copolymers described ..............
in paragraph (a)(3)(ii) of this
section and manufactured with 1-
alkenes having from 6 to 10 carbon
atoms
3.3b. Olefin copolymers described
in paragraph (a)(3)(ii) of this
section, provided that such olefin
polymers have a melt temperature of
220 deg.C to 250 deg.C (428
deg.F to 482 deg.F) as determined
by the method described in
paragraph (d)(8) of this section
and minimum intrinsic viscosity of
1.0 as determined in paragraph
(d)(9) of this section.
[[Page 276]]
3.4. Olefin copolymers, primarily 0.85-0.90
non-crystalline, described in par.
(a)(3) (iii) of this section
provided that such olefin polymers
have a minimum viscosity average
molecular weight of 120,000 as
determined by the method described
in par. (d)(5) of this section and
a minimum Mooney viscosity of 35 as
determined by the method described
in par. (d)(6) of this section, and
further provided that such olefin
copolymers contact food only of the
types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX
3.5. Olefin copolymers, primarily 0.85-0.90
non-crystalline, described in
paragraph (a)(3)(iv) of this
section, provided that such olefin
polymers have a minimum viscosity
average molecular weight of 95,600
as determined by the method
described in paragraph (d)(5) of
this section, and further provided
that such olefin polymers are used
only in blends with olefin polymers
described under items 1.1, 2.1, and
2.2 of this table at a maximum
level of 25 pct by weight, and
provided that such olefin
copolymers contact food only of the
types identified in Sec. 176.170
(c) of this chapter, table 1, under
Types I, II, IV-B, VI, VII-B, and
VIII at temperatures not exceeding
190 deg.F
3.6. Olefin copolymers described in Not less than
paragraph (a)(3)(v) of this section 0.88
for use in blends with olefin
polymer resins have a melt flow
index no greater than 5 grams/10
minutes as determined by the method
described in paragraph (d)(7) of
this section and the thickness of
the finished blends shall not
exceed 0.1 millimeter (0.004 inch).
The ethylene/butene-1 copolymer may
be used subject to the following
conditions: (1) For use at a level
not to exceed 20 weight percent in
polypropylene as described under
item 1.1 of this table. (2) For use
at a level not to exceed 40 weight
percent in polyethylene as
described under items 2.1 and 2.2
of this table. (3) For use at a
level not to exceed 40 weight
percent in olefin copolymers as
described under items 3.1 and 3.2
of this table
[[Page 277]]
3.7. Ethylene/propylene copolymers, Not less than
meeting the identity described in 0.86
paragraph (a)(3)(i) of this
section, containing not less than
80 mole-percent of polymer units
derived from ethylene and having a
minimum viscosity average molecular
weight of 95,000 as determined by
the method described in paragraph
(d)(5) of this section, and a
minimum Mooney viscosity of 13 as
determined by the method described
in paragraph (d)(6) of this
section. Ethylene/propylene
copolymers described in this item
3.7 are to be used only in blends
with other olefin polymers
complying with this section, at
levels not to exceed 30 percent by
weight of the total polymer blend,
and in contact with food only of
types identified in Sec.
176.170(c) of this chapter, Table
1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX.
Additionally, optional adjuvants
permitted for use in olefin
copolymers complying with item 3.4
of this table may be used in the
production of this copolymer
3.8. Olefin polymers described in
paragraph (a)(3)(vi) of this
section, having a melt flow index
not to exceed 9.2 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, for use in blends
with other polymers at levels not
to exceed 8 percent by weight of
total polymer, subject to the
limitation that when contacting
food of types III, IV-A, V, VI-C,
VII-A, and IX, identified in Sec.
176.170(c) of this chapter, Table
1, the polymers shall be used only
under conditions of use C, D, E, F,
and G, described in Sec.
176.170(c) of this chapter, Table
2.
3.9. Olefin copolymers described in Not less than ................
paragraph (a)(3)(vii) of this 1.0
section may only be used in contact
with dry foods, Type VIII, as
identified in Sec. 176.170(c) of
this chapter, Table 1
4. Poly(methylpentene) 0.82-0.85 MP: 235 deg.-250 6.6 pct at 7.5 pct at 25
deg.C. reflux deg.C
temperature
5. Polyethylene copolymer described Not less than .................. 0.45 pct at 15 1.8 pct at 25
in paragraph (a)(5) of this section 0.94 deg.C deg.C
and having a melt index not to
exceed 2, for use, either alone or
in blends with other olefin
polymers, subject to the limitation
that when contacting foods of types
III, IV-A, V, VI-C, VII-A, VIII,
and IX identified in Sec.
176.170(c) of this chapter, table
1, the thickness of the film (in
mils) containing the polyethylene
graft copolymer times the
concentration of the polyethylene
graft copolymer shall not exceed a
value of 2
6. Ethylene-maleic anhydride 0.92 or greater ................ 1.36 pct at 50 2.28 pct at 25
copolymers described in paragraph deg.C deg.C
(a)(6) of this section for use as
the adhesive component in
multilaminate structures, or as the
sealant layer in flexible
packaging, in contact with food at
temperatures not exceeding 49
deg.C (120 deg.F)
----------------------------------------------------------------------------------------------------------------
(d) The analytical methods for determining whether olefin polymers
conform to the specifications prescribed in this section are as follows,
and are applicable to the basic polymer in film form not exceeding 4
mils in thickness.
[[Page 278]]
The film to be tested shall be cut into approximately 1-inch squares by
any convenient method that avoids contamination by dust, dirt, or grease
(Note: Do not touch samples with bare fingers--use forceps to hold or
transfer samples).
(1) Density. Density shall be determined by ASTM method D1505-68
(Reapproved 1979), ``Standard Test Method for Density of Plastics by the
Density-Gradient Technique,'' 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.
(2) Melting point or softening point--(i) Melting point. The melting
point shall be determined by ASTM method D2117-82, ``Standard Test
Method for Melting Point of Semicrystalline Polymers by the Hot Stage
Microscopy Method,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(ii) Softening point. The softening point shall be determined by
ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (d)(1) of this section.
(3) Maximum extractable fraction in n-hexane--(i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpentene). A sample is refluxed in the solvent for 2 hours and
filtered at the boiling point. The filtrate is evaporated and the total
residue weighed as a measure of the solvent extractable fraction.
(a) Apparatus. (1) Erlenmeyer flasks, 250-milliliter, with ground
joint.
(2) Condensers, Allihn, 400-millimeter jacket, with ground joint.
(3) Funnels, ribbed 75-millimeter diameter, stem cut to 40
millimeters.
(4) Funnels, Buchner type, with coarse-porosity fritted disc, 60-
millimeter diameter.
(5) Bell jar for vacuum filtration into beaker.
(b) Reagent. n-Hexane, commercial grade, specific gravity 0.663-
0.667 (20 deg.C/20 deg.C), boiling range 66 deg.C-69 deg.C, or
equivalent.
(c) Procedure. Weigh 1 gram of sample accurately and place in a 250-
milliliter Erlenmeyer flask containing two or three boiling stones. Add
100 milliliters of solvent, attach the flask to the condenser (use no
grease), and reflux the mixture for 2 hours. Remove the flask from the
heat, disconnect the condenser, and filter rapidly, while still hot,
through a small wad of glass wool packed in a short-stem funnel into a
tared 150-millimeter beaker. Rinse the flask and filter with two 10-
milliliter portions of the hot solvent, and add the rinsings to the
filtrate. Evaporate the filtrate on a stream bath with the aid of a
stream of nitrogen. Dry the residue in a vacuum oven at 110 deg.C for 2
hours, cool in a desiccator, and weigh to the nearest 0.0001 gram.
Determine the blank on 120 milliliters of solvent evaporated in a tared
150-milliliter beaker. Correct the sample residue for this blank if
significant. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.398
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A preweighed sample is extracted at 50 deg.C
for 2 hours and filtered. The filtrate is evaporated and the total
residue weighed as a measure of the solvent extractable fraction.
Alternatively, the sample is reweighed after the extraction period to
give a measure of the solvent extractable fraction. The maximum n-
hexane-extractable fraction may be determined by the methods set forth
in paragraphs (d)(3)(ii)(a) through (d)(3)(ii)(i) of this section.
(a) Extraction apparatus. Two-liter, straight-walled, Pyrex (or
equivalent)
[[Page 279]]
resin kettles, fitted with three-hole ground-glass covers are most
convenient for this purpose. The cover is fitted with a thermometer, a
gas-tight stirrer driven by an air motor or explosion-proof electric
motor, and a reflux condenser. The kettle is fitted with an electric
heating mantle of appropriate size and shape, which is controlled by a
variable-voltage transformer.
(b) Evaporating apparatus. Rapid evaporation of large volumes of
solvent requires special precautions to prevent contamination by dust.
This is facilitated by a special ``gas'' cover consisting of an inverted
flat Pyrex crystallizing dish of an appropriate size (190 millimeters
x 100 millimeters) to fit a 1-liter beaker. Through the center of the
dish are sealed an inlet tube for preheated, oxygen-free nitrogen, and
an outlet tube located 1 inch off center. Nitrogen is fed from the
supply source through a coil of \1/4\-inch stainless steel tubing
immersed in the same steam bath used to supply heat for solvent
evaporation. All connections are made with flexible tetrafluoroethylene
tubing.
(c) Reagents--(1) n-Hexane. Spectrograde n-hexane.
(2) Nitrogen. High-purity dry nitrogen containing less than 10 parts
per million of oxygen.
(d) Procedure. Transfer 2.5 grams (accurately weighed to nearest
0.001 gram) of the polymer to the resin kettle. Add 1 liter of solvent
and clamp top in position. Start water flowing through jacket of the
reflux condenser and apply air pressure to the stirring motor to produce
vigorous agitation. Turn on heating jacket with transformer set at a
predetermined voltage to bring the temperature of the contents to 50
deg.C within 20-25 minutes. As the thermometer reading approaches 45
deg.C-47 deg.C, reduce the voltage to the predetermined setting that
will just maintain the temperature at 50 deg.C. Do not overshoot the
prescribed temperature. Should this occur discard the test and start
afresh. Exactly 2 hours after the solvent temperature has reached 50
deg.C, disconnect the heater, remove the resin kettle from the heating
jacket, and decant the solvent, while still warm, through a coarse
filter paper placed on top of a fritted-glass funnel, collecting the
filtrate in a tared, glass-stoppered Erlenmeyer flask of 1-liter
capacity. Determine the weight of the filtrate recovered to the nearest
gram. Recovery should be at least 90 percent of the original solvent.
Losses due to evaporation during heating and filtering have been found
not to exceed 10 percent. Transfer about half of the solvent filtrate to
a 1-liter beaker placed on an opening in the steam bath and immediately
cover with the special ``gas'' cover, the inlet tube of which has been
attached with flexible tetrafluoroethylene tubing to a source of high-
purity nitrogen in series with a stainless steel heating coil immersed
directly in the body of the steam bath. Maintain a positive flow of warm
nitrogen gas throughout the evaporation of the solvent, adding the
remainder of the filtrate from the Erlenmeyer flask as the evaporation
proceeds. When the volume of the solvent has been reduced to about 50
milliliters, transfer the concentrated liquid to a previously tared
weighing dish of suitable size. Wash the beaker twice with 20-30
milliliter portions of warm solvent, adding the washings to the weighing
dish while continuing to evaporate the remainder of the solvent under
the gas cover with its flow of warm nitrogen directed toward the center
of the dish. In the event that an insoluble residue that cannot be
removed with warm solvent remains in the beaker, it may be necessary to
heat with a small amount of a higher boiling solvent such as benzene or
toluene, transferring these washings to the weighing dish before final
evaporation to dryness. Transfer the weighing dish with its residue to a
vacuum desiccator, and allow it to remain overnight (at least 12 hours),
after which the net weight of the dry residue is determined to the
nearest 0.0001 gram. Correct the result for any solvent blank equivalent
to the nonvolatile matter determined to be contained in the amount of
solvents used in the test.
(e) Extraction apparatus for alternate method. Two-liter extraction
vessel, such as a resin kettle or round bottom flask, fitted with an
Allihn condenser (size C), a 45/50 male joint with a Teflon sleeve, and
a Teflon coated stir bar. Water bath maintained at 49.5 deg.C
plus-minus0.5
[[Page 280]]
deg.C containing a submersible magnetic stirrer motor with power
supply. Other suitable means of maintaining temperature control, such as
electric heating mantles, may be used provided that the temperature
range can be strictly maintained.
(f) Sample basket (Optional). A perforated stainless steel
cylindrical basket that is approximately 1.5 inches in diameter, 1.6
inches high, and has perforations of 0.125 inches in diameter for 33
holes/in2, or 40 percent open area. The basket should pass
freely through the 45/50 female joint of the extraction flask. A No. 6-
32 stainless steel eye-bolt is attached to the lid for positioning the
basket in the extraction vessel. The positioning rod, approximately 18
inches long and made from 1/16 inch outside diameter 316 stainless steel
welding rod or equivalent and hooked at both ends, is used to position
the basket in the extraction apparatus.
(g) Vacuum oven. Capable of maintaining 80 deg.C
plus-minus5 deg.C and a minimum of 635 millimeters of
mercury pressure.
(h) Reagents. n-Hexane, reagent or spectrograde, aromatic free (less
than 1 milligram per liter), minimum 85 percent n-hexane. This reagent
may be reused until it contains a maximum of 1.5 grams polyolefin
extractables or has been used for 12 determinations.
(i) Procedure. Assemble the extraction vessel, condenser, and
magnetic stir bar. Add n-hexane (1 liter) to the extraction vessel and
clamp the assembly into a water bath set at 49.5 deg.C
plus-minus0.5 deg.C. Start the water flowing through the
jacket of the reflux condenser. Adjust the air flow through the stirring
motor to give a smooth and uniform stir rate. Allow the n-hexane to
preheat for 1 hour to bring the temperature to 49.5
deg.Cplus-minus0.5 deg.C. Temperature is a critical factor
in this analysis and it must not vary more than 1 deg.C. If the
temperature exceeds these limits, the test must be discontinued and
restarted. Blown, compression molded, or extrusion cast films can be
tested. Ideally, the film should be prepared by the same process as will
be used with the production resin. Using gloves and metal tweezers to
avoid sample contamination, cut about 2.7 grams of the prepared film (4
mils or less in thickness) into about 1-inch squares using clean sharp
scissors. Proceed with Option 1 or 2.
Option 1. Using tweezers and noting the number of film pieces,
transfer 2.5 grams (accurately weighed to 0.1 milligram) of polymer to
the extraction vessel. Extract the film sample for 2 hours. Allow the
vessel to cool and filter the contents through a fritted porcelain
funnel. Wash the film pieces with fresh n-hexane, aspirate to dryness,
and transfer, using tweezers, to a beaker. Recount the film pieces to
verify that none were lost during the transfer. Place the beaker in the
vacuum oven for 2 hours at 80 deg.C plus-minus5 deg.C.
After 2 hours, remove and place in a desiccator to cool to room
temperature (about 1 hour). After cooling, reweigh the film pieces to
the nearest 0.1 milligram. Calculate the percent hexane-extractables
content from the weight loss of the original sample. Multiply the result
by 0.935 and compare with extraction limits in paragraph (c) of this
section. Repeat the above procedure for successive samples.
Option 2. Transfer 2.5plus-minus0.05 grams of the
prepared 1-inch film sections into a tared sample basket and accurately
weigh to the nearest 0.1 milligram. Carefully raise the condenser until
the hook on the positioning rod is above the neck of the 2-liter
extraction vessel. The basket should be totally below the level of n-
hexane solvent. Extract the sample resin film for 2 hours and then raise
the basket above the solvent level to drain momentarily. Remove the
basket and rinse the contents by immersing several times in fresh n-
hexane. Allow the basket to dry between rinsings. Remove the excess
solvent by briefly blowing the basket with a stream of nitrogen or dry
air. Place the basket in the vacuum oven for 2 hours at 80 deg.C
plus-minus5 deg.C. After 2 hours, remove and place in a
desiccator to cool to room temperature (about 1 hour). After cooling,
reweigh the basket to the nearest 0.1 milligram. Calculate the percent
hexane extractables content from the weight loss of the original sample.
Multiply the result by 0.935 and compare with extraction limits in
paragraph (c) of this section. Repeat the above procedure for successive
samples. The same solvent charge should remain clear and can be used for
[[Page 281]]
at least 12 determinations. Applications of solvent reuse should be
confirmed for each resin type before use.
(4) Maximum soluble fraction in xylene--(i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpen-tene). A sample is dissolved completely in xylene by
heating and stirring in a bottle with little free space. The solution is
allowed to cool without stirring, whereupon the insoluble portion
precipitates and is filtered off; the total solids content of the
filtrate is then determined as a measure of the soluble fraction.
(a) Apparatus. (1) Pyrex (or equivalent) reagent bottle, 125-
milliliter, glass-stoppered.
(2) Heating mantle of size for 150-milliliter beaker (or suitable
aluminum block to fit the 125-milliter bottle described in paragraph
(d)(4)(i)(a)(1) of this section.
(3) Magnetic stirrer for use under the heating mantle (combination
magnetic stirrer and hotplate may be used if aluminum block is used in
place of heating mantle).
(4) Variable-voltage transformer, 7.5 amperes.
(5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.
(6) Constant temperature water bath maintained at 25
deg.Cplus-minus0.5 deg.C.
(7) Aluminum dishes, 18 millimeters x 60 millimeters, disposable.
(8) Funnel, Buchner type, with coarse-porosity fritted disc, 30-60
millimeter diameter.
(b) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of phenyl-
- naphthylamine in 1 liter of industrial grade xylene having
specific gravity 0.856-0.867 (20 deg.C/20 deg.C) and boiling range 123
deg.C-160 deg.C.
(c) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001
gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-
inch long tetrafluoroethylene-resin-coated stirring bar. Add 100
milliliters of solvent, set the stopper in lightly, and place the bottle
in the heating mantle or aluminum block maintained at a temperature of
120 deg.C, and stir with a magnetic stirrer until the sample is
completely dissolved. Remove the bottle from the heat and allow it to
cool 1 hour in the air, without stirring. Then place the bottle in a
water bath maintained at 25 deg.C plus-minus0.5 deg.C, and
allow to stand 1 hour without stirring. Next, remove the bottle from the
water bath, shake, and pour part of the contents into the coarse-
porosity fritted-glass funnel. Apply suction, and draw 30-40 milliliters
of filtrate through, adding more slurry to the funnel, and catching the
filtrate in a large test tube. (If the slurry is hard to filter, add 10
grams of diatomaceous earth filter aid to the bottle and shake
vigorously just prior to the filtration.) Pipet a suitable aliquot
(preferably 20 milliliters) of the filtrate into a tared aluminum
disposable dish. Place the dish on a steam bath covered with a fresh
sheet of aluminum foil and invert a short-stemmed 4-inch funnel over the
dish. Pass nitrogen (heated if desired) down through the funnel at a
rate sufficient to just ripple the surface of the solvent. When the
liquid has evaporated, place the dish in a vacuum oven at 140 deg.C and
less than 50 millimeters mercury pressure for 2 hours. Cool in a
desiccator and weigh. (Note: If the residue value seems high, redry in
the vacuum oven for one-half hour to ensure complete removal of all
xylene solvent.) Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.399
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A sample is extracted in xylene at reflux
temperature for 2 hours and filtered. The filtrate is evaporated and the
total residue weighed as a measure of soluble fraction.
(a) Apparatus--(1) Extraction apparatus. Two-liter, straight-walled
Pyrex (or equivalent) resin kettles, fitted
[[Page 282]]
with ground-glass covers, are most convenient for this purpose. The
cover is equipped with a thermometer and an efficient reflux condenser.
The kettle is fitted with an electric heating mantle of appropriate size
and shape which is controlled by a variable-voltage transformer.
(2) Constant temperature water bath. It must be large enough to
permit immersion of the extraction kettle and set to maintain 25 deg.C
plus-minus0.1 deg.C.
(3) Evaporating apparatus. Gas cover consisting of a flat Pyrex
crystallizing dish (190 millimeters x 100 millimeters) inverted to fit
over a 1-liter beaker with 8-millimeter gas inlet tube sealed through
center and an outlet tube 1 inch off center. The beaker with gas cover
is inserted in an electric heating mantle equipped with a variable-
voltage transformer. The outlet tube is attached to an efficient
condenser mounted on a receiving flask for solvent recovery and having
an outlet for connection to an aspirator pump. The heating mantle (with
the beaker) is mounted on a magnetic stirring device. An infrared heat
lamp is mounted vertically 3-4 inches above the gas cover to prevent
condensation of the solvent inside the cover. Make all connections with
flexible tetrafluoroethylene tubing.
(b) Reagents--(1) Xylene. American Chemical Society reagent grade
that has been redistilled through a fractionating column to reduce the
nonvolatile residue.
(2) Nitrogen. High-purity dry nitrogen containing less than 104
parts per million oxygen.
(c) Procedure. Transfer 5 grams plus-minus0.001 gram of
sample to the resin kettle, add 1,000 milliliters (840 grams) of xylene,
and clamp top in position after inserting a piece of glass rod to
prevent bumping during reflux. Start water flowing through the jacket of
the reflux condenser and apply full voltage (115 volts) to the heating
mantle. When the xylene starts to boil, reduce the voltage to a level
just sufficient to maintain reflux. After refluxing for at least 2
hours, disconnect the power source to the mantle, remove the kettle, and
allow to cool in air until the temperature of the contents drops to 50
deg.C, after which the kettle may be rapidly cooled to 25 deg.C-30
deg.C by immersing in a cold water bath. Transfer the kettle to a
constant temperature bath set to maintain 25 deg.C
plus-minus0.1 deg.C, and allow to equilibrate for a least 1
hour (may be left overnight if convenient). Break up any precipitated
polymers that may have formed, and decant the xylene solution
successively through a fast filter paper and then through a fritted-
glass filter into a tared 1-liter Erlenmeyer flask, collecting only the
first 450 milliliters--500 milliliters of filtrate (any attempt to
collect more of the xylene solution usually results in clogging the
filter and risking losses). Reweigh the Erlenmeyer flask and calculate
the weight of the filtrate obtained to the nearest 0.1 gram. Transfer
the filtrate, quantitatively, from the Erlenmeyer flask to the 1-liter
beaker, insert the beaker in its heating mantle, add a glass-coated
magnetic stirring bar, and mount the gas cover in place, connecting the
inlet tube to the nitrogen source and the outlet to the condenser of the
receiving flask. Start a flow of nitrogen (2 to 3 liters per minute)
into the gas cover and connect an aspirator to the receiver using a
free-flow rate equivalent to 6-7 liters of air per minute. With the
infrared lamp on, adjust the voltage to the heating mantle to give a
distillation rate of 12-13 milliliters per minute when the magnetic
stirrer is revolving just fast enough to promote good boiling. When the
volume of solvent in the beaker has been reduced to 30-50 milliliters,
transfer the concentrated extractive to a suitable weighing dish that
has been previously tared (dry). Rinse the beaker twice with 10-20
milliliter portions of fresh xylene, adding the rinsings to the weighing
dish. Evaporate the remainder of the xylene on an electric hotplate set
at low heat under the gas cover with a stream of nitrogen directed
toward the center of the dish. Avoid any charring of the residue.
Transfer the weighing dish to a vacuum desiccator at room temperature
and allow to remain under reduced pressure for at least 12 hours
(overnight), after which determine the net weight of the residue to the
nearest 0.0001 gram. Correct the result for nonvolatile solvent blank
obtained by evaporating the equivalent amount of
[[Page 283]]
xylene under identical conditions. Calculate the weight of residue
originally present in the total weight of solvent (840 grams), using the
appropriate factor based on the weight of filtrate evaporated.
(5) Viscosity average molecular weight olefin copolymers described
in paragraphs (a)(3) (iii) and (iv) of this section. The viscosity
average molecular weight shall be determined from the kinematic
viscosity (using ASTM method D445-74, ``Test for Kinematic Viscosity of
Transparent and Opaque Liquids'' (Revised 1974), which is incorporated
by reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) of solutions of the
copolymers in solvents and at temperatures as follows:
(i) Olefin polymers described in paragraph (a)(3)(iii) of this
section in decahydronaphthalene at 135 deg.C.
(ii) Olefin polymers described in paragraph (a)(3)(iv) of this
section in tetrachloroethylene at 30 deg.C.
(6) Mooney viscosity--olefin copolymers described in paragraph
(a)(3)(iii) of this section. Mooney viscosity is determined by ASTM
method D1646-81, ``Standard Test Method for Rubber--Viscosity and
Vulcanization Characteristics (Mooney Viscometer),'' which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (d)(1) of this section), using the large
rotor at a temperature of 100 deg.C, except that a temperature of 127
deg.C shall be used for those copolymers whose Mooney viscosity cannot
be determined at 100 deg.C. The apparatus containing the sample is
warmed for 1 minute, run for 8 minutes, and viscosity measurements are
then made.
(7) Melt flow index. The melt flow index of olefin polymers
described below shall be determined by ASTM method D-1238-82, ``Standard
Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a).
The availability of this incorporation by reference is given in
paragraph (d)(1) of this section. The olefin polymers and test
conditions and procedures are as follows:
------------------------------------------------------------------------
List of polymers Conditions/procedures
------------------------------------------------------------------------
Olefin copolymers described in Condition L, procedure A.
paragraph (a)(3)(i)(c)(2) of this
section.
Olefin copolymers described in Condition E, procedure A.
paragraph (a)(3)(v) of this section.
Olefin polymers described in paragraph Condition E, procedure A.
(a)(2)(ii) of this section.
Olefin polymers described in paragraph Condition E, procedure A.
(a)(3)(vi) of this section.
------------------------------------------------------------------------
(8) Melting peak temperature. The melt temperature of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 3418-82, ``Standard Test Method for
Transition Temperatures of Polymers by Thermal Analysis,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a). The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(9) Intrinsic viscosity. The intrinsic viscosity of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 1601-78, ``Standard Test Method for Dilute
Solution Viscosity of Ethylene Polymers,'' which is incorporated by
reference in accordance with 5 U.S.C. 552(a). The availability of this
incorporation by reference is given in paragraph (d)(1) of this section.
(e) Olefin copolymers described in paragraph (a)(3) (i) of this
section and polyethylene, alone or in combination, may be subjected to
irradiation bombardment from a source not to exceed 2.3 million volts
intensity to cause molecular crosslinking of the polymers to impart
desired properties, such as increased strength and increased ability to
shrink when exposed to heat.
(f) The olefin polymers identified in and complying with this
section, when used as components of the food-contact surface of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178, and Sec. 179.45 of this chapter, shall comply with any
specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
(g) The provisions of this section are not applicable to olefin
polymers identified in Sec. 175.105(c) (5) of this chapter
[[Page 284]]
and used in food-packaging adhesives complying with Sec. 175.105 of this
chapter.
[42 FR 14572, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 177.1520, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.