Food and Drug Administration, HHS § 177.

1520

by reference. The availability of this (c)(1) Olefin basic copolymers manu-

incorporation by reference is given in factured by the catalytic copolym-
paragraph (c)(5)(i) of this section. erization of two or more of the
[42 FR 14572, Mar. 15, 1977, as amended at 45
monomers ethylene, propylene, butene-
FR 2844, Jan. 15, 1980; 48 FR 30361, July 1, 1, 2-methylpropene-1, and 2,4,4-
1983; 48 FR 33478, July 22, 1983; 48 FR 36099, trimethylpentene-1 shall contain not
Aug. 9, 1983; 51 FR 33250, Sept. 19, 1986; 52 FR less than 85 weight-percent of polymer
26667, July 16, 1987; 52 FR 33575, Sept. 4, 1987; units derived from ethylene and/or pro-
52 FR 39635, Oct. 23, 1987; 52 FR 42760, Nov. 6, pylene;
1987; 53 FR 19773, May 31, 1988; 54 FR 29019, (2) Olefin basic copolymers manufac-
July 11, 1989; 58 FR 2977, Jan. 7, 1993; 58 FR
32610, June 11, 1993; 61 FR 14481, Apr. 2, 1996]
tured by the catalytic copolymeriza-
tion of propylene and butene-1 shall
§ 177.1520 Olefin polymers. contain greater than 15 but not greater
than 35 weight percent of polymer
The olefin polymers listed in para-
units derived from butene-1 with the
graph (a) of this section may be safely
used as articles or components of arti- remainder being propylene.
cles intended for use in contact with (d) Olefin basic terpolymers manufac-
food, subject to the provisions of this tured by the catalytic copolymeriza-
section. tion of ethylene, hexene-1, and either
(a) For the purpose of this section, propylene or butene-1, shall contain
olefin polymers are basic polymers not less than 85 weight percent poly-
manufactured as described in this para- mer units derived from ethylene.
graph, so as to meet the specifications (e) Olefin basic copolymers manufac-
prescribed in paragraph (c) of this sec- tured by the catalytic polymerization
tion, when tested by the methods de- of ethylene and octene-1, or ethylene,
scribed in paragraph (d) of this section. octene-1, and either hexene-1, butene-1,
(1) Polypropylene consists of basic propylene, or 4-methylpentene-1 shall
polymers manufactured by the cata- contain not less than 80 weight percent
lytic polymerization of propylene. of polymer units derived from ethyl-
(2) Polyethylene consists of basic ene.
polymers manufactured by the cata- (ii) 4-Methylpentene-1 and 1-alkenes
lytic polymerization of ethylene. having 6 to 10 carbon atoms. Such
(3) Olefin basic copolymers consist of olefin basic copolymers shall contain
basic copolymers manufactured by the not less than 95 molar percent of poly-
catalytic copolymerization of: mer units derived from 4-
(i) Two or more of the 1-alkenes hav- methylpentene-1; or
ing 2 to 8 carbon atoms. Such olefin (iii) Ethylene and propylene that
basic copolymers contain not less than may contain as modifiers not more
96 weight-percent of polymer units de- than 5 weight-percent of total polymer
rived from ethylene and/or propylene, units derived by copolymerization with
except that: one or more of the following
(a)(1) Olefin basic copolymers manu- monomers:
factured by the catalytic copolym-
5-Ethylidine-2-norbornene.
erization of ethylene and hexene-1 or 5-Methylene-2-norbornene.
ethylene and octene-1 shall contain not
less than 90 weight-percent of polymer (iv) Ethylene and propylene that may
units derived from ethylene; contain as a modifier not more than 4.5
(2) Olefin basic copolymers manufac- weight percent of total polymer units
tured by the catalytic copolymeriza- derived by copolymerization with 1,4-
tion of ethylene and hexene-1 shall con- hexadiene.
tain not less than 80 but not more than (v) Ethylene and butene-1 copolymers
90 weight percent of polymer units de- (CAS Reg. No. 25087–34–7) that shall
rived from ethylene. contain not less than 80 weight percent
(b) Olefin basic copolymers manufac- of polymer units derived from ethyl-
tured by the catalytic copolymeriza- ene.
tion of ethylene and 4-methylpentene-1 (4) Poly(methylpentene) consists of
shall contain not less than 89 weight- basic polymers manufactured by the
percent of polymer units derived from catalytic polymerization of 4-
ethylene; methylpentene-1.

259
§ 177.1520 21 CFR Ch. I (4–1–96 Edition)

(5) Polyethylene graft copolymers (b) The basic olefin polymers identi-
consist of polyethylene complying with fied in paragraph (a) of this section
item 2.2 of paragraph (c) of this section may contain optional adjuvant sub-
which subsequently has 3a,4,7,7a- stances required in the production of
tetrahydromethyl-4,7- such basic olefin polymers. The op-
methanoisobenzofuran-1,3-dione graft- tional adjuvant substances required in
ed onto it at a level not to exceed 1.7 the production of the basic olefin poly-
percent by weight of the finished co- mers or finished food-contact articles
polymer. may include substances permitted for
such use by applicable regulations in
(6) Ethylene-maleic anhydride co-
parts 170 through 189 of this chapter,
polymers (CAS Reg. No. 9006–26–2) con-
substances generally recognized as safe
taining no more than 2 percent by
in food and food packaging, substances
weight of copolymer units derived from used in accordance with a prior sanc-
maleic anhydride. tion or approval, and the following:
Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent
Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para-
erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may
cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV–B, VI–A through
220 ° C (428 ° F), and the subsequent catalytic hydro- VI–C, VII–B, and VIII identified in Table 1 of § 176.170(c) of
genation of the resulting aromatic petroleum hydrocarbon this chapter and under conditions of use B through H de-
resin, having a minimum softening point of 110 ° C (230 ° F), scribed in Table 2 of § 176.170(c) of this chapter; and with
as determined by ASTM Method E 28–67 (Reapproved food Types III, IV–A, V, VII–A, and IX identified in Table 1 of
1982), ‘‘Standard Test Method for Softening Point by Ring- § 176.170(c) of this chapter and under conditions of use D
and-Ball Apparatus,’’ and a minimum aniline point of 107 ° C through G described in Table 2 of § 176.170(c) of this
(225 ° F), as determined by ASTM Method D 611–82, chapter.
‘‘Standard Test Methods for Aniline Point and Mixed Aniline
Point of Petroleum Products and Hydrocarbon Solvents,’’
both of which are incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are avail-
able 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 § 178.3297 of this chapter
2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene
63–7). homopolymer complying with § 177.1520(c), item 1.1 and
olefin copolymers complying with § 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 Poly-
propylene,’’ which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutri-
tion (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.

260
Food and Drug Administration, HHS § 177.1520

Substance Limitations

Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent
genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with
mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of
codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight
cyclopentadiene, and C4–C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item
drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con-
°C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-
approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with food types I, II,
by Ring-and-Ball Apparatus,’’ and a minimum viscosity of IV–B, VI–A, VI–B, VII–B, and VIII identified in Table 1 of
3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C
ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in Table 2 of § 176.170(c) of this chap-
parent Viscosity of Hot Melt Adhesives and Coating Mate- ter.
rials,’’ both of which are incorporated by reference in accord-
ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are
available from the American Society for Testing and Mate-
rials, 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.
Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin
79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev-
rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The
Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions
Method for Rheological Properties of Thermoplastics with a described in § 176.170(c) of this chapter, Table 2, under
Capillary Rheometer’’ using a capillary of 15:1 L/D, which is conditions of use B though H.
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, Washing-
ton, DC.
Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin
68937–54–2). polymers that comply with § 177.1520(c) at levels not to ex-
ceed 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 § 176.170 of this
chapter.
Triisopropanolamine (CAS Reg. No. 122–20–3) ........................ For use as a Zeigler-Natta-type catalyst deactivator and anti-
oxidant in the production of olefin polymers complying with
§ 177.1520(c), items 2.1, 2.2, and 2.3, and having a mini-
mum density of 0.94 grams per cubic centimeter, and co-
polymers complying with § 177.1520(c), items 3.1 and 3.2,
for use in contact with all foods under the following condi-
tions 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 § 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 de-
fined in Table 2 of § 176.170(c) of this chapter.
Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of
by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and
(CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1,
trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad-
27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million
not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers.
more than 6 percent.
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded
No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight
cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only
a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap-
by reference in accordance with 5 U.S.C. 552(a). Copies are ter, Table 2, under conditions of use B through H.
available from the Center for Food Safety and Applied Nutri-
tion (HFS–200), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be examined at the Of-
fice of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.

261
§ 177.1520 21 CFR Ch. I (4–1–96 Edition)

Substance Limitations

Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin
No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev-
less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The
and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions
100¥1 seconds at 232 °C as determined by ASTM Method D described in § 176.170(c) of this chapter, Table 2, under
3835–79 (Reapproved 1983), ‘‘Standard Test Method for conditions of use B though H.
Rheological Properties of Thermoplastics with a Capillary
Rheometer’’ using a capillary of 15:1 L/D, which is incor-
porated 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:

262
 Maximum extractable Maximum soluble
fraction (expressed as fraction (expressed as
Melting point (MP) or percent by weight of percent by weight of
Olefin polymers Density softening point (SP) polymer) in N-hexane polymer) in xylene at
(Degrees Centigrade) at specified tempera- specified tempera-
tures tures

1.1 Polypropylene ................................................................................................................................... 0.880–0.913 MP:160°–180° C ....... 6.4 pct at reflux tem- 9.8 pct at 25° C.
perature.
1.2 Polypropylene, noncrystalline; for use only to plasticize polyethylene described under items 2.1 0.80–0.88 .................................... ....................................
and 2.2 of this table, provided that such plasticized polymers meet the maximum extractable frac-
tion and maximum soluble fraction specifications prescribed for such basic polyethylene.
1.3 Polypropylene, noncrystalline, for use only: To plasticize polypropylene described by item 1.1 of 0.80–0.88 SP:115°–138° C ........ ....................................
this table, provided that such plasticized polymers meet the maximum extractable fraction and
maximum soluble fraction specifications prescribed for such basic polypropylene, and further pro-
vided that such plasticized polypropylene contacts food only of the types identified in § 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 coat-
ings contact food only of the types identified in § 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 articles that contact food except for articles used for packing or holding 0.85–1.00 .................................... 5.5 pct at 50° C ......... 11.3 pct at 25° C.
Food and Drug Administration, HHS

food during cooking.

2.2 Polyethylene for use in articles used for packing or holding food during cooking .......................... 0.85–1.00 .................................... 2.6 pct at 50° C ......... Do.
2.3 Polyethylene for use only as component of food-contact coatings at levels up to and including 0.85–1.00 .................................... 53 pct at 50° C .......... 75 pct at 25° C.
50 percent by weight of any mixture employed as a food-contact coating.

263
3.1a Olefin copolymers described in paragraph (a)(3)(i) of this section for use in articles that contact 0.85–1.00 .................................... 5.5 pct at 50° C ......... 30 pct at 25° C
food except for articles used for packing or holding food during cooking; except 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 paragraph (a)(3)(i)(e) of this section for use in contact with food 0.9–1.00 .................................... Do. ............................. Do.
only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, Table 2.
3.2a Olefin copolymers described in paragraph (a)(3)(i) of this section for use in articles used for 0.85–1.00 .................................... 2.6 percent at 50 ° C Do.
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 § 176.170(c) of this chapter, Table 1, shall not ex-
ceed 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 § 176.170(c) of this chapter, Table 2. Additionally, olefin copolymers de-
scribed 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 § 176.170(c) of this chapter, Table 2, in contact with all food types identi-
fied in § 176.170(c) of this chapter, Table 1.
3.2b Olefin copolymers described in paragraph (a)(3)(i)(c)(2) of this section have a melt flow index Do. .................................... .................................... .
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 com-
plying with item 3.2a of this table may be used in the production of this copolymer.
3.3a Olefin polymers described in paragraph (a)(3)(ii) of this section. .................................................. 0.82–0.85 MP: 235–250 °C ....... 6.6 pct at reflux ......... 7.5 pct at 25 °C.
§ 177.1520
 Maximum extractable Maximum soluble
fraction (expressed as fraction (expressed as
Melting point (MP) or percent by weight of percent by weight of
Olefin polymers Density softening point (SP) polymer) in N-hexane polymer) in xylene at
(Degrees Centigrade) at specified tempera- specified tempera-
tures tures
§ 177.1520
3.3b Olefin copolymers described in paragraph (a)(3)(ii) of this section, provided that such olefin 0.82–0.85
polymers have a melt temperature of 220 °C to 250 °C (428 °F to 482 °F) as determined by the
method described in paragraph (d)(8) of this section and minimum intrinsic viscosity of 1.0 as de-
termined in paragraph (d)(9) of this section.
3.4 Olefin copolymers, primarily non-crystalline, described in par. (a)(3) (iii) of this section provided 0.85–0.90 .................................... ....................................
that such olefin polymers have a minimum viscosity average molecular weight of 120,000 as de-
termined 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 § 176.170(c) of this chap-
ter, Table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX.
3.5 Olefin copolymers, primarily non-crystalline, described in paragraph (a)(3)(iv) of this section, 0.85–0.90 .................................... ....................................
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 § 176.170 (c) of this chapter, Table 1,
under Types I, II, IV-B, VI, VII-B, and VIII at temperatures not exceeding 190° F.
3.6 Olefin copolymers described in paragraph (a)(3)(v) of this section for use in blends with olefin Not less .
polymer resins have a melt flow index no greater than 5 grams/10 minutes as determined by the than 0.88

264
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.
4. Poly(methylpentene) ........................................................................................................................... 0.82–0.85 MP: 235°–250° C. ..... 6.6 pct at reflux tem- 7.5 pct at 25° C.
perature.
5. Polyethylene copolymer described in paragraph (a)(5) of this section and having a melt index not Not less ............................... 0.45 pct at 15 °C ....... 1.8 pct at 25 °C.
to exceed 2, for use, either alone or in blends with other olefin polymers, subject to the limitation than 0.94
that when contacting foods of types III, IV-A, V, VI-C, VII-A, VIII, and IX identified in § 176.170(c)
of this chapter, Table 1, the thickness of the film (in mils) containing the polyethylene graft co-
polymer times the concentration of the polyethylene graft copolymer shall not exceed a value of 2.
6. Ethylene-maleic anhydride copolymers described in paragraph (a)(6) of this section for use as 0.92–0.94 .................................... 1.36 pct at 50° C. ...... 2.28 pct at 25 ° C.
the adhesive component in multilaminate structures, or as the sealant layer in flexible packaging, .........
in contact with food at temperatures not exceeding 49° C (120° F).
21 CFR Ch. I (4–1–96 Edition)
Food and Drug Administration, HHS § 177.1520

(d) The analytical methods for deter- in paragraph (a)(3)(ii) of this section,
mining whether olefin polymers con- polypropylene, and poly(methylpentene).
form to the specifications prescribed in A sample is refluxed in the solvent for
this section are as follows, and are ap- 2 hours and filtered at the boiling
plicable to the basic polymer in film point. The filtrate is evaporated and
form not exceeding 4 mils in thickness. the total residue weighed as a measure
The film to be tested shall be cut into of the solvent extractable fraction.
approximately 1-inch squares by any (a) Apparatus. (1) Erlenmeyer flasks,
convenient method that avoids con- 250-milliliter, with ground joint.
tamination by dust, dirt, or grease (2) Condensers, Allihn, 400-millimeter
(NOTE: Do not touch samples with bare jacket, with ground joint.
fingers—use forceps to hold or transfer (3) Funnels, ribbed 75-millimeter di-
samples). ameter, stem cut to 40 millimeters.
(1) Density. Density shall be deter- (4) Funnels, Buchner type, with
mined by ASTM method D1505–68 (Re- coarse-porosity fritted disc, 60-millime-
approved 1979), ‘‘Standard Test Method ter diameter.
for Density of Plastics by the Density- (5) Bell jar for vacuum filtration into
Gradient Technique,’’ which is incor- beaker.
porated by reference. Copies may be (b) Reagent. n-Hexane, commercial
obtained from the American Society grade, specific gravity 0.663–0.667 (20° C/
for Testing Materials, 1916 Race St., 20° C), boiling range 66° C-69° C, or
Philadelphia, PA 19103, or may be ex- equivalent.
amined at the Office of the Federal (c) Procedure. Weigh 1 gram of sample
Register, 800 North Capitol Street, accurately and place in a 250-milliliter
NW., suite 700, Washington, DC 20408. Erlenmeyer flask containing two or
(2) Melting point or softening point—(i) three boiling stones. Add 100 milliliters
Melting point. The melting point shall of solvent, attach the flask to the con-
be determined by ASTM method D2117– denser (use no grease), and reflux the
82, ‘‘Standard Test Method for Melting mixture for 2 hours. Remove the flask
Point of Semicrystalline Polymers by from the heat, disconnect the con-
the Hot Stage Microscopy Method,’’ denser, and filter rapidly, while still
which is incorporated by reference. The hot, through a small wad of glass wool
availability of this incorporation by packed in a short-stem funnel into a
reference is given in paragraph (d)(1) of tared 150-millimeter beaker. Rinse the
this section. flask and filter with two 10-milliliter
(ii) Softening point. The softening portions of the hot solvent, and add the
point shall be determined by ASTM rinsings to the filtrate. Evaporate the
method E28–67 (Reapproved 1982), filtrate on a stream bath with the aid
‘‘Standard Test Method for Softening of a stream of nitrogen. Dry the resi-
Point by Ring-and-Ball Apparatus,’’ due in a vacuum oven at 110° C for 2
which is incorporated by reference. The hours, cool in a desiccator, and weigh
availability of this incorporation by to the nearest 0.0001 gram. Determine
reference is given in paragraph (d)(1) of the blank on 120 milliliters of solvent
this section. evaporated in a tared 150-milliliter
(3) Maximum extractable fraction in n- beaker. Correct the sample residue for
hexane—(i) Olefin copolymers described this blank if significant. Calculation:

Grams of residue
= Percent extractable with n-hexane.
Grams of sample × 100

(ii) Olefin copolymers described in para- the total residue weighed as a measure
graph (a)(3)(i) of this section and poly- of the solvent extractable fraction. Al-
ethylene. A preweighed sample is ex- ternatively, the sample is reweighed
tracted at 50 ° C for 2 hours and fil- after the extraction period to give a
tered. The filtrate is evaporated and measure of the solvent extractable

265
§ 177.1520 21 CFR Ch. I (4–1–96 Edition)

fraction. The maximum n-hexane-ex- afresh. Exactly 2 hours after the sol-
tractable fraction may be determined vent temperature has reached 50° C,
by the methods set forth in paragraphs disconnect the heater, remove the resin
(d)(3)(ii)(a) through (d)(3)(ii)(i) of this kettle from the heating jacket, and de-
section. cant the solvent, while still warm,
(a) Extraction apparatus. Two-liter, through a coarse filter paper placed on
straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting
resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered
ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity.
ient for this purpose. The cover is Determine the weight of the filtrate re-
fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery
stirrer driven by an air motor or explo- should be at least 90 percent of the
sion-proof electric motor, and a reflux original solvent. Losses due to evapo-
condenser. The kettle is fitted with an ration during heating and filtering
electric heating mantle of appropriate have been found not to exceed 10 per-
size and shape, which is controlled by a cent. Transfer about half of the solvent
variable-voltage transformer. filtrate to a 1-liter beaker placed on an
(b) Evaporating apparatus. Rapid opening in the steam bath and imme-
evaporation of large volumes of solvent diately cover with the special ‘‘gas’’
requires special precautions to prevent cover, the inlet tube of which has been
contamination by dust. This is facili- attached with flexible tetrafluoro-
tated by a special ‘‘gas’’ cover consist- ethylene tubing to a source of high-pu-
ing of an inverted flat Pyrex crystalliz- rity nitrogen in series with a stainless
ing dish of an appropriate size (190 mil- steel heating coil immersed directly in
limeters x 100 millimeters) to fit a 1- the body of the steam bath. Maintain a
liter beaker. Through the center of the positive flow of warm nitrogen gas
dish are sealed an inlet tube for throughout the evaporation of the sol-
preheated, oxygen-free nitrogen, and vent, adding the remainder of the fil-
an outlet tube located 1 inch off center. trate from the Erlenmeyer flask as the
Nitrogen is fed from the supply source evaporation proceeds. When the volume
through a coil of 1⁄4-inch stainless steel of the solvent has been reduced to
tubing immersed in the same steam about 50 milliliters, transfer the con-
bath used to supply heat for solvent centrated liquid to a previously tared
evaporation. All connections are made weighing dish of suitable size. Wash the
with flexible tetrafluoroethylene tub- beaker twice with 20–30 milliliter por-
ing. tions of warm solvent, adding the
(c) Reagents—(1) n-Hexane. washings to the weighing dish while
Spectrograde n-hexane. continuing to evaporate the remainder
(2) Nitrogen. High-purity dry nitrogen of the solvent under the gas cover with
containing less than 10 parts per mil- its flow of warm nitrogen directed to-
lion of oxygen. ward the center of the dish. In the
(d) Procedure. Transfer 2.5 grams (ac- event that an insoluble residue that
curately weighed to nearest 0.001 gram) cannot be removed with warm solvent
of the polymer to the resin kettle. Add remains in the beaker, it may be nec-
1 liter of solvent and clamp top in posi- essary to heat with a small amount of
tion. Start water flowing through jack- a higher boiling solvent such as ben-
et of the reflux condenser and apply air zene or toluene, transferring these
pressure to the stirring motor to washings to the weighing dish before
produce vigorous agitation. Turn on final evaporation to dryness. Transfer
heating jacket with transformer set at the weighing dish with its residue to a
a predetermined voltage to bring the vacuum desiccator, and allow it to re-
temperature of the contents to 50° C main overnight (at least 12 hours),
within 20–25 minutes. As the thermom- after which the net weight of the dry
eter reading approaches 45° C–47° C, re- residue is determined to the nearest
duce the voltage to the predetermined 0.0001 gram. Correct the result for any
setting that will just maintain the solvent blank equivalent to the non-
temperature at 50° C. Do not overshoot volatile matter determined to be con-
the prescribed temperature. Should tained in the amount of solvents used
this occur discard the test and start in the test.

266
Food and Drug Administration, HHS § 177.1520

(e) Extraction apparatus for alternate should be prepared by the same process
method. Two-liter extraction vessel, as will be used with the production
such as a resin kettle or round bottom resin. Using gloves and metal tweezers
flask, fitted with an Allihn condenser to avoid sample contamination, cut
(size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4
sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1-
Water bath maintained at 49.5° C ±0.5° inch squares using clean sharp scissors.
C containing a submersible magnetic Proceed with Option 1 or 2.
stirrer motor with power supply. Other Option 1. Using tweezers and noting
suitable means of maintaining tem- the number of film pieces, transfer 2.5
perature control, such as electric heat- grams (accurately weighed to 0.1 milli-
ing mantles, may be used provided that gram) of polymer to the extraction ves-
the temperature range can be strictly
sel. Extract the film sample for 2
maintained.
hours. Allow the vessel to cool and fil-
(f) Sample basket (Optional). A per-
ter the contents through a fritted por-
forated stainless steel cylindrical bas-
ket that is approximately 1.5 inches in celain funnel. Wash the film pieces
diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry-
forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a
33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to ver-
The basket should pass freely through ify that none were lost during the
the 45/50 female joint of the extraction transfer. Place the beaker in the vacu-
flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80° C±5° C. After
bolt is attached to the lid for position- 2 hours, remove and place in a desicca-
ing the basket in the extraction vessel. tor to cool to room temperature (about
The positioning rod, approximately 18 1 hour). After cooling, reweigh the film
inches long and made from 1/16 inch pieces to the nearest 0.1 milligram.
outside diameter 316 stainless steel Calculate the percent hexane-
welding rod or equivalent and hooked extractables content from the weight
at both ends, is used to position the loss of the original sample. Multiply
basket in the extraction apparatus. the result by 0.935 and compare with
(g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of
taining 80° C ±5° C and a minimum of this section. Repeat the above proce-
635 millimeters of mercury pressure. dure for successive samples.
(h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of
spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a
milligram per liter), minimum 85 per- tared sample basket and accurately
cent n-hexane. This reagent may be re- weigh to the nearest 0.1 milligram.
used until it contains a maximum of 1.5 Carefully raise the condenser until the
grams polyolefin extractables or has hook on the positioning rod is above
been used for 12 determinations. the neck of the 2-liter extraction ves-
(i) Procedure. Assemble the extraction
sel. The basket should be totally below
vessel, condenser, and magnetic stir
the level of n-hexane solvent. Extract
bar. Add n-hexane (1 liter) to the ex-
the sample resin film for 2 hours and
traction vessel and clamp the assembly
into a water bath set at 49.5° C ±0.5° C. then raise the basket above the solvent
Start the water flowing through the level to drain momentarily. Remove
jacket of the reflux condenser. Adjust the basket and rinse the contents by
the air flow through the stirring motor immersing several times in fresh n-
to give a smooth and uniform stir rate. hexane. Allow the basket to dry be-
Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol-
hour to bring the temperature to 49.5° vent by briefly blowing the basket with
C±0.5° C. Temperature is a critical fac- a stream of nitrogen or dry air. Place
tor in this analysis and it must not the basket in the vacuum oven for 2
vary more than 1° C. If the temperature hours at 80° C±5° C. After 2 hours, re-
exceeds these limits, the test must be move and place in a desiccator to cool
discontinued and restarted. Blown, to room temperature (about 1 hour).
compression molded, or extrusion cast After cooling, reweigh the basket to
films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate

267
§ 177.1520 21 CFR Ch. I (4–1–96 Edition)

the percent hexane extractables con- thylamine in 1 liter of industrial grade

tent from the weight loss of the origi- xylene having specific gravity 0.856–
nal sample. Multiply the result by 0.935 0.867 (20° C/20° C) and boiling range 123°
and compare with extraction limits in C–160° C.
paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of
the above procedure for successive sample to the nearest 0.001 gram and
samples. The same solvent charge place in a 125-milliliter Pyrex reagent
should remain clear and can be used for bottle containing a 1-inch long tetra-
at least 12 determinations. Applica- fluoroethylene-resin-coated stirring
tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set
firmed for each resin type before use. the stopper in lightly, and place the
(4) Maximum soluble fraction in xy- bottle in the heating mantle or alu-
lene—(i) Olefin copolymers described in minum block maintained at a tempera-
paragraph (a)(3)(ii) of this section, poly- ture of 120° C, and stir with a magnetic
propylene, and poly(methylpen-tene). A stirrer until the sample is completely
sample is dissolved completely in dissolved. Remove the bottle from the
xylene by heating and stirring in a bot- heat and allow it to cool 1 hour in the
tle with little free space. The solution air, without stirring. Then place the
is allowed to cool without stirring, bottle in a water bath maintained at
whereupon the insoluble portion 25° C±0.5° C, and allow to stand 1 hour
precipitates and is filtered off; the without stirring. Next, remove the bot-
total solids content of the filtrate is tle from the water bath, shake, and
then determined as a measure of the pour part of the contents into the
soluble fraction. coarse-porosity fritted-glass funnel.
(a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli-
lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more
glass-stoppered. slurry to the funnel, and catching the
(2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the
liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of
block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the
scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior
this section. to the filtration.) Pipet a suitable ali-
(3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the
heating mantle (combination magnetic filtrate into a tared aluminum dispos-
stirrer and hotplate may be used if alu- able dish. Place the dish on a steam
minum block is used in place of heat- bath covered with a fresh sheet of alu-
ing mantle). minum foil and invert a short-stemmed
(4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro-
amperes. gen (heated if desired) down through
(5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just
stirring bar, 1-inch long. ripple the surface of the solvent. When
(6) Constant temperature water bath the liquid has evaporated, place the
maintained at 25° C±0.5° C. dish in a vacuum oven at 140° C and
(7) Aluminum dishes, 18 millimeters x less than 50 millimeters mercury pres-
60 millimeters, disposable. sure for 2 hours. Cool in a desiccator
(8) Funnel, Buchner type, with and weigh. (Note: If the residue value
coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven
meter diameter. for one-half hour to ensure complete
(b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula-
Dissolve 0.020 gram of phenyl-β- naph- tion:

Grams of residue 100 milliters

× × 100 = Percent soluble in xylene
Grams of sample volume of aliquot in milliliters

268
Food and Drug Administration, HHS § 177.1520

(ii) Olefin copolymers described in para- reflux condenser and apply full voltage
graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When
ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the
lene at reflux temperature for 2 hours voltage to a level just sufficient to
and filtered. The filtrate is evaporated maintain reflux. After refluxing for at
and the total residue weighed as a least 2 hours, disconnect the power
measure of soluble fraction. source to the mantle, remove the ket-
(a) Apparatus—(1) Extraction appara- tle, and allow to cool in air until the
tus. Two-liter, straight-walled Pyrex temperature of the contents drops to
(or equivalent) resin kettles, fitted 50° C, after which the kettle may be
with ground-glass covers, are most con- rapidly cooled to 25° C–30° C by immers-
venient for this purpose. The cover is ing in a cold water bath. Transfer the
equipped with a thermometer and an kettle to a constant temperature bath
efficient reflux condenser. The kettle is set to maintain 25° C ±0.1° C, and allow
fitted with an electric heating mantle to equilibrate for a least 1 hour (may
of appropriate size and shape which is be left overnight if convenient). Break
controlled by a variable-voltage trans- up any precipitated polymers that may
former. have formed, and decant the xylene so-
(2) Constant temperature water bath. It lution successively through a fast filter
must be large enough to permit immer- paper and then through a fritted-glass
sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer
maintain 25° C±0.1° C. flask, collecting only the first 450 mil-
(3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any
consisting of a flat Pyrex crystallizing attempt to collect more of the xylene
dish (190 millimeters x 100 millimeters) solution usually results in clogging the
inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the
with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the
through center and an outlet tube 1 weight of the filtrate obtained to the
inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate,
cover is inserted in an electric heating quantitatively, from the Erlenmeyer
mantle equipped with a variable- flask to the 1-liter beaker, insert the
voltage transformer. The outlet tube is beaker in its heating mantle, add a
attached to an efficient condenser glass-coated magnetic stirring bar, and
mounted on a receiving flask for sol- mount the gas cover in place, connect-
vent recovery and having an outlet for ing the inlet tube to the nitrogen
connection to an aspirator pump. The source and the outlet to the condenser
heating mantle (with the beaker) is of the receiving flask. Start a flow of
mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into
An infrared heat lamp is mounted ver- the gas cover and connect an aspirator
tically 3–4 inches above the gas cover to the receiver using a free-flow rate
to prevent condensation of the solvent equivalent to 6–7 liters of air per
inside the cover. Make all connections minute. With the infrared lamp on, ad-
with flexible tetrafluoroethylene tub- just the voltage to the heating mantle
ing. to give a distillation rate of 12–13 milli-
(b) Reagents—(1) Xylene. American liters per minute when the magnetic
Chemical Society reagent grade that stirrer is revolving just fast enough to
has been redistilled through a promote good boiling. When the vol-
fractionating column to reduce the ume of solvent in the beaker has been
nonvolatile residue. reduced to 30–50 milliliters, transfer
(2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit-
containing less than 104 parts per mil- able weighing dish that has been pre-
lion oxygen. viously tared (dry). Rinse the beaker
(c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of
gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the
1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain-
and clamp top in position after insert- der of the xylene on an electric
ing a piece of glass rod to prevent hotplate set at low heat under the gas
bumping during reflux. Start water cover with a stream of nitrogen di-
flowing through the jacket of the rected toward the center of the dish.

269
§ 177.1520 21 CFR Ch. I (4–1–96 Edition)

Avoid any charring of the residue. (7) Melt flow index. The melt flow
Transfer the weighing dish to a vacu- index of olefin polymers described
um desiccator at room temperature below shall be determined by ASTM
and allow to remain under reduced method D–1238–82, ‘‘Standard Test
pressure for at least 12 hours (over- Method for Flow Rates of Thermo-
night), after which determine the net plastics by Extrusion Plastometer,’’
weight of the residue to the nearest which is incorporated by reference in
0.0001 gram. Correct the result for non- accordance with 5 U.S.C. 552(a). The
volatile solvent blank obtained by availability of this incorporation by
evaporating the equivalent amount of reference is given in paragraph (d)(1) of
xylene under identical conditions. Cal- this section. The olefin polymers and
culate the weight of residue originally test conditions and procedures are as
present in the total weight of solvent follows:
(840 grams), using the appropriate fac- List of polymers Conditions/procedures
tor based on the weight of filtrate
Olefin copolymers described in para- Condition L, proce-
evaporated. graph (a)(3)(i)(c)(2) of this section. dure A.
(5) Viscosity average molecular weight Olefin copolymers described in para- Condition E, proce-
olefin copolymers described in paragraphs graph (a)(3)(v) of this section. dure A.
(a)(3) (iii) and (iv) of this section. The
viscosity average molecular weight (8) Melting peak temperature. The melt
shall be determined from the kine- temperature of the olefin polymers de-
matic viscosity (using ASTM method scribed in paragraph (a)(3)(ii) of this
D445–74, ‘‘Test for Kinematic Viscosity section shall be determined by ASTM
of Transparent and Opaque Liquids’’ method D 3418–82, ‘‘Standard Test
(Revised 1974), which is incorporated by Method for Transition Temperatures of
reference; copies are available from Polymers by Thermal Analysis,’’ which
American Society for Testing and Ma- is incorporated by reference in accord-
terials (ASTM), 1916 Race Street, ance with 5 U.S.C. 552(a). The availabil-
Philadelphia, PA 19103, or available for ity of this incorporation by reference is
inspection at the Office of the Federal given in paragraph (d)(1) of this sec-
Register, 800 North Capitol Street, tion.
(9) Intrinsic viscosity. The intrinsic
NW., suite 700, Washington, DC 20408) of
viscosity of the olefin polymers de-
solutions of the copolymers in solvents
scribed in paragraph (a)(3)(ii) of this
and at temperatures as follows:
section shall be determined by ASTM
(i) Olefin polymers described in para- method D 1601–78, ‘‘Standard Test
graph (a)(3)(iii) of this section in Method for Dilute Solution Viscosity
decahydronaphthalene at 135° C. of Ethylene Polymers,’’ which is incor-
(ii) Olefin polymers described in porated by reference in accordance
paragraph (a)(3)(iv) of this section in with 5 U.S.C. 552(a). The availability of
tetrachloroethylene at 30° C. this incorporation by reference is given
(6) Mooney viscosity—olefin copolymers in paragraph (d)(1) of this section.
described in paragraph (a)(3)(iii) of this (e) Olefin copolymers described in
section. Mooney viscosity is determined paragraph (a)(3) (i) of this section and
by ASTM method D1646–81, ‘‘Standard polyethylene, alone or in combination,
Test Method for Rubber—Viscosity and may be subjected to irradiation bom-
Vulcanization Characteristics (Mooney bardment from a source not to exceed
Viscometer),’’ which is incorporated by 2.3 million volts intensity to cause mo-
reference (the availability of this in- lecular crosslinking of the polymers to
corporation by reference is given in impart desired properties, such as in-
paragraph (d)(1) of this section), using creased strength and increased ability
the large rotor at a temperature of 100° to shrink when exposed to heat.
C, except that a temperature of 127° C (f) The olefin polymers identified in
shall be used for those copolymers and complying with this section, when
whose Mooney viscosity cannot be de- used as components of the food-contact
termined at 100° C. The apparatus con- surface of any article that is the sub-
taining the sample is warmed for 1 ject of a regulation in parts 174, 175,
minute, run for 8 minutes, and viscos- 176, 177, 178, and § 179.45 of this chapter,
ity measurements are then made. shall comply with any specifications

270
Food and Drug Administration, HHS § 177.1550

and limitations prescribed by such reg- List of substances Limitations

ulation for the article in the finished
Lithium polysilicate containing For use only as a compo-
form in which it is to contact food. not more than 20 weight per- nent of repeated-use
(g) The provisions of this section are cent silica, not more than 2.1 coatings not exceeding
not applicable to olefin polymers iden- percent lithium oxide and 0.030 millimeter (0.0012
having a maximum mole inch) in thickness where
tified in § 175.105(c) (5) of this chapter ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally
and used in food-packaging adhesives cured at minimum sinter-
complying with § 175.105 of this chapter. ing temperatures of 371°
C (700° F). Lithium ex-
[42 FR 14572, Mar. 15, 1977] tractives shall not exceed
1.55 milligrams per
EDITORIAL NOTE: For FEDERAL REGISTER ci- square decimeter (0.1
tations affecting § 177.1520, see the List of milligram per square inch)
CFR Sections Affected in the Finding Aids of coating surface when
section of this volume. tested in accordance with
paragraph (e)(2) of this
section.
§ 177.1550 Perfluorocarbon resins.
Naphthalene sulfonic acid For use only:
Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re-
this section may be safely used as arti- sodium salt. peated-use coatings,
based on the
cles or components of articles intended perfluorocarbon resin
to contact food, subject to the provi- identified in paragraph
sions of this section: (a)(1) of this section, not
to exceed 0.030 millime-
(a) Identity. For the purpose of this ter (0.0012 inch) in thick-
section, perfluorocarbon resins are ness, and at a level not to
those produced by: (1) The exceed 0.4 weight per-
cent of the coating.
homopolymerization and/or copolym-
2. As a component of re-
erization of hexafluoropropylene and peated-use coatings,
tetrafluoroethylene, and (2) the co- based on the
polymerization of perfluorocarbon resin
identified in paragraph
perfluoropropylvinylether and tetra- (a)(2) of this section, not
fluoroethylene (CAS Reg. No. 26655–00– to exceed 0.10 millimeter
5). The resins shall meet the (0.004 inch) in thickness,
extractives limitations in paragraph and at a level not to ex-
ceed 0.4 weight percent
(d) of this section. of the coating.
(b) Optional components. The
perfluorocarbon resins identified in (c) Optional processing. Poly- tetra-
paragraph (a) of this section as well as fluoroethylene resins may be irradi-
articles or coating made from these ated by either a cobalt-60 sealed
resins may include the following op- source, at a maximum dose of gamma
tional components except that the radiation not to exceed 7.5 megarads,
resin identified in paragraph (a)(2) of or an electron beam at energy levels
this section may not be used with the not to exceed 2.5 million electron volts
optional component, lithium
with a maximum dosage of 7.5
polysilicate, mentioned in paragraph
megarads, to produce lubricant pow-
(b)(4) of this section.
ders having a particle diameter of not
(1) Substances generally recognized
more than 20 microns for use only as
as safe (GRAS) in food or food packag-
ing subject to any limitations cited on components of articles intended for re-
their use. peated use in contact with food.
(2) Substances used in accordance (d) Specifications—(1) Infrared identi-
with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be
ject to any limitations cited in the identified by their characteristic infra-
prior sanction or approval. red spectra.
(3) Substances authorized under ap- (2) Melt-viscosity. (i) The
plicable regulations in this part and in perfluorocarbon resins identified in
parts 175 and 178 of this chapter and paragraph (a)(1) of this section shall
subject to any limitations prescribed have a melt viscosity of not less than
therein. 104 poises at 380° C (716° F) as deter-
(4) The following substances, subject mined by ASTM method D1238–82,
to any limitations prescribed: ‘‘Standard Test Method for Flow Rates

271