21 CFR Ch. I (4–1–07 Edition) §177.1520
(which has been held in a vacuum des-iccator over anhydrous calcium sulfate until constant weight has been at-tained) and carefully evaporated to dryness. The weight of the solid residue is determined by difference after hold-ing in a vacuum desiccator over anhy-drous calcium sulfate until constant weight has been attained. The percent of solids extracted is calculated by di-viding the weight of the solid residue by the weight of the sample and multi-plying by 100.
(5) Viscosity number (VN). (i) The vis-cosity number (VN) for Nylon 6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin per milliliter) shall be determined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides- Determination of Viscosity Number,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra-tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspec-tion at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: v/ federal l register/
code l of l federal l regulations/
建筑工程技术
ibr l locations.html.
(ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA–6–3–T resins in a 99 percent cresol solution (5 milli-grams resin per milliliter) shall be de-termined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides-De-termination of Viscosity Number,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (d)(5)(i) of this ction.
[42 FR 14572, Mar. 15, 1977]
E DITORIAL N OTE: For
F EDERAL R EGISTER ci-tations affecting §177.1500, e the List of CFR Sections Affected, which appears in the Finding Aids ction of the printed volume and on GPO Access.
§177.1520Olefin polymers.
The olefin polymers listed in para-graph (a) of this ction may be safely ud as articles or components of arti-cles intended for u in contact with food, subject to the provisions of this ction.
(a) For the purpo of this ction, olefin polymers are basic polymers manufactured as described in this para-graph, so as to meet the specifications prescribed in paragraph (c) of this c-tion, when tested by the methods de-scribed in paragraph (d) of this ction.
(1)(i) Polypropylene consists of basic polymers manufactured by the cata-lytic 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 cata-lytic polymerization of ethylene.
(ii) Fumaric acid-grafted poly-ethylene (CAS Reg. No. 26877–81–6) con-sists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fu-maric acid in the abnce of free rad-ical initiators. Such polymers shall contain grafted fumaric acid at levels 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 hav-ing 2 to 8 carbon atoms. Such olefin basic copolymers contain not less than 96 weight-percent of polymer units de-rived from ethylene and/or propylene, except that:
(a)(1) Olefin basic copolymers manu-factured by the catalytic copolym-erization 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 manufac-tured by the catalytic copolymeriza-tion of ethylene and hexene-1 shall con-tain not less than 80 but not more than 90 weight percent of polymer units de-rived from ethylene.
(3) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of ethylene and pentene-1 shall contain not less than 90 weight-percent of polymer units derived from ethyl-ene.
(4) Olefin basic copolymers manufac-tured by the catalytic polymerization of ethylene and octene-1 shall contain not less than 50 weight-percent of poly-mer units derived from ethylene.
Food and Drug Administration, HHS §177.1520
(b ) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion 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 manu-factured by the catalytic copolym-erization of two or more of the mono-mers 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 pro-pylene;
(2) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion 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 manufac-tured by the catalytic copolymeriza-tion of ethylene, hexene-1, and either propylene or butene-1, shall contain not less than 85 weight percent poly-mer units derived from ethylene.
(e ) Olefin basic copolymers manufac-tured 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 ethyl-ene.
(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 poly-mer units derived from 4-
methylpentene-1, except that copoly-mers manufactured with 1-alkenes hav-ing from 12 to 18 carbon atoms shall contain not less than 97 molar percent
of polymer units derived from 4-
methylpentene-1; or
(iii) E thylene 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 mono-mers:
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 copolymer
s (CAS Reg. No. 25087–34–7) that shall contain not less than 80 weight percent of polymer units derived from ethyl-ene.
(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 abnce of free rad-ical 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 fu-maric acid by weight of the finished polymer.
祖父母的英文(vii) Ethylene and 2-norbornene (CAS Reg. No. 26007–43–2) copolymers that shall contain not less than 30 and not 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 ction which subquently has 3a,4,7,7a-
tetrahydromethyl-4,7- methanoisobenzofuran-1,3-dione graft-ed onto it at a level not to exceed 1.7 percent by weight of the finished co-polymer.
(6) E thylene-maleic anhydride co-polymers (CAS Reg. No. 9006–26–2) con-taining no more than 2 percent by weight of copolymer units derived from maleic anhydride.
(b) The basic olefin polymers identi-fied in paragraph (a) of this ction may contain optional adjuvant sub-stances required in the production of such basic olefin polymers. The op-tional adjuvant substances required in the production of the basic olefin poly-mers or finished food-contact articles
may include substances permitted for such u by applicable regulations in
parts 170 through 189 of this chapter, substances generally recognized as safe
in food and food packaging, substances ud in accordance with a prior sanc-tion or approval, and the following:
21 CFR Ch. I (4–1–07 Edition)
§177.1520
Substance Limitations
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526–47–0), produced by the catalytic polym-erization of aromatic-substituted olefins from distillates of cracked petroleum stocks with a boiling point no greater than 220 °C (428 °F), and the subquent catalytic hydrogenation of the resulting aromatic petroleum hydrocarbon resin, hav-ing a minimum softening point of 110 °C (230 °F), as deter-mined by ASTM Method E 28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), as determined by ASTM Method D 611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petro-leum 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 available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: v/ federal l register/code l of l federal l regulations/
ibr l locations.html..For u only as an adjuvant at levels not to exceed 25 percent by weight in blends with polypropylene complying with para-graph (c), item 1.1 of this ction. The finished polymer may be ud in contact with food Types I, II, IV-B, VI-A through VI-C, VII-B, and VIII identified in table 1 of §176.170(c) of this chapter and under conditions of u B through H de-scribed in table 2 of §176.170(c) of this chapter; and with food Types III, IV-A, V, VII-A, and IX identified in table 1 of §176.170(c) of this chapter and under conditions of u D through G described in table 2 of §176.170(c) of this chap-ter.
Colorants ud in accordance with §178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– 63–7).For u as an initiator in the production of propylene 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 max-imum 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the
National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: v/federal l register/
code l of l federal l regulations/ibr l locations.html.
Methyl methacrylate/butyl acrylate-grafted polypropylene co-polymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510–09–6), methyl meth-acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 14–7), and polypropylene (CAS Reg. No. 9003–07–0), re-sulting from the reaction of a mixture of methyl 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 de-termined 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be exam-ined at the Center for Food Safety and Applied Nutrition’s Li-brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
202–741–6030, or go to: v/ federal l register/code l of l federal l regulations/
ibr l locations.html..For u only at levels not to exceed 6 percent by weight of olefin polymers complying with paragraph (c) of this ction, items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com-plying with items 3.1a, 3.2a, and 3.2b contain not less than 85 weight-percent of polymer units derived from propylene.
Food and Drug Administration, HHS §177.1520
Substance Limitations
Petroleum hydrocarbon resins (cyclopentadiene-type), hydro-
genated (CAS Reg. No. 68132–00–3) produced by the ther-
mal polymerization of dicyclopentadiene and cyclodiene
codimers (consisting of a mixture of cyclopentadiene, methyl
cyclopentadiene, and C4-C5acyclic dienes), followed by hy-
drogenation and having a ring-and-ball softening point of 119 °C minimum as determined by ASTM Method E 28–67 (Re-approved 1982), ‘‘Standard Test Method for Softening Point
by Ring-and-Ball Apparatus,’’ and a minimum viscosity of
3,000 centipoi, measured at 160 °C, as determined by
ASTM Method D 3236–88, ‘‘Standard Test Method for Ap-
parent Viscosity of Hot Melt Adhesives and Coating Mate-
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, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or from the Center For Food Safety简介模板
and Applied Nutrition (HFS–200), Food and Drug Administra-
tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or
may be examined at the National Archives and Records Ad-
ministration (NARA). For information on the availability of this
material at NARA, call 202–741–6030, or go to:
v/federal l register/
code l of l federal l regulations/ibr l locations.html..For u only as an adjuvant at levels not to exceed 30 percent by weight in blends with: (1) Polypropylene complying with paragraph (c), item 1.1 of this ction, or (2) a copolymer of propylene and ethylene containing not less than 94 weight percent propylene and complying with paragraph (c), item 3.2 of this ction. The average thickness of the food-con-tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-ished polymer may be ud in contact with (1) Food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of §176.170(c) of this chapter and under conditions of u C through G described in table 2 of §176.170(c) of this chap-ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi-fied in table 1 of §176.170(c) of this chapter and under con-ditions of u D through G described in table 2 of §176.170(c) of this chapter.
Polymethylsilsquioxane (CAS Reg. No. 68554–70–1)............For u only as a surface lubricant or anti-blocking agent in
films.
Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– 79–9), having a melt viscosity of 6 to 37 kilopoi at a shear rate of 100¥1conds at 232 °C as determined by ASTM Method D 3835–79 (Reapproved 1983), ‘‘Standard Test Method for Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na-tional Archives and Records Administration (NARA). For in-formation on the availability of this material at NARA, call 202–741–6030, or go to: v/ federal l register/code l of l federal l regulations/
ibr l locations.html..For u only as a processing aid in the production of olefin polymers complying with paragraph (c) of this ction at lev-els not to exceed 1.0 percent by weight of the polymer. The finished polymers may be ud only under the conditions de-scribed in §176.170(c) of this chapter, table 2, under condi-tions of u B though H.
Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. 68937–54–2).For u as an extrusion aid in the production of extruded olefin 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 ud in contact with foods under conditions of u B through H described in table 2 of §176.170 of this chapter.
Triisopropanolamine (CAS Reg. No. 122–20–3)........................For u 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 min-
imum density of 0.94 grams per cubic centimeter, and co-
polymers complying with §177.1520(c), items 3.1 and 3.2,
for u in contact with all foods under the following condi-
tions of u: (a) films with a maximum thickness of 0.102
millimeter (0.004 inch) may be ud 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 ud under conditions C through G de-
fined in table 2 of §176.170(c) of this chapter.
Trimethylpyridine and dimethylpyridine mixture having percent by weight composition as follows: 2,4,6-trimethylpyridine (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- trimethylpyridine (CAS Reg. No. 1462–84–6), not more than 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), not more than 12 percent; and other dimethylpyridines, not more than 6 percent.For u only as an adjuvant substance in the production of propylene homopolymers complying with items 1.1, 1.2, and 1.3, and propylene copolymers complying with items 3.1, and 3.2 of paragraph (c) of this ction provided that the ad-juvant is ud at a level not to exceed 20 parts per million by weight of the olefin polymers.
21 CFR Ch. I (4–1–07 Edition)
§177.1520
Substance Limitations
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011–17–0) having a fluorine content of 65 to 71 per-cent and a Mooney viscosity of at least 28, as determined by a method entitled ‘‘Mooney Viscosity,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the Center for Food Safety and Applied Nutri-tion (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be exam-ined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: v/ federal l register/code l of l federal l regulations/
文字成语
ibr l locations.html..For u only as an extrusion aid in the production of extruded olefin polymers at levels not to exceed 0.2 percent by weight of the polymer. The finished polymers may be ud only under the conditions described in §176.170(c) of this chap-ter, table 2, under conditions of u B through H.
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011–17–0), having a vinylidene fluoride content of not less than 87 percent but less than 100 percent by weight and a melt viscosity
of 12 to 27 kilopoi at a shear rate of 100¥1conds at 232 °C as determined by ASTM Method D 3835–79 (Reapproved 1983), ‘‘Standard Test Method for 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: v/federal l register/ code l of l federal l regulations/ibr l locations.html..For u only as a processing aid in the production of olefin polymers complying with paragraph (c) of this ction at lev-els not to exceed 1.0 percent by weight of the polymer. The finished polymers may be ud only under the conditions de-scribed in §176.170(c) of this chapter, table 2, under condi-tions of u B though H.
(c) Specifications:
Olefin polymers Density
Melting Point
(MP) or softening
point (SP) (De-
grees Centi-
grade)–
Maximum extract-
able fraction (ex-
presd as per-
cent by weight of
the polymer) in N-
hexane at speci-
fied temperatures
Maximum soluble
fraction (ex-
presd as per-
悟禅cent by weight of
polymer) in xy-
lene at specified
temperatures
1.1a. Polypropylene described in para-graph (a)(1)(i) of this ction 0.880–0.913 MP:采访记录
160°–180 °C 6.4 pct at reflux
temperature
9.8 pct at 25 °C
1.1b. Propylene homopolymer described in paragraph (a)(1)(ii) of this ction 0.880–0.913– MP:
150°–180 °C 6.4 pct at reflux
temperature
9.8 pct at 25 °C
1.2. Polypropylene, noncrystalline; for u
only to plasticize polyethylene described
under items 2.1 and 2.2 of this table, pro-
vided that such plasticized polymers meet
恩施风景the maximum extractable fraction and max-
imum soluble fraction specifications pre-
scribed for such basic polyethylene
0.80–0.88
1.3. Polypropylene, noncrystalline, for u
only: To plasticize polypropylene described
by item 1.1 of this table, provided that such
plasticized polymers meet the maximum ex-
tractable 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
§176.170(c) of this chapter, table 1, under
Types I, II, IV-B, VI-B, VII-B, and VIII; and
for u at levels not to exceed 50 pct by
weight of any mixture employed as a food-
contact coating provided such coatings con-
tact food only of the types identified in
§176.170(c) of this chapter, table 1, under
经久不忘
Types I, II, IV-B, VI-B, VII-B, and VIII
0.80–0.88 SP:115°–138 °C.
2.1. Polyethylene for u in articles that con-
tact food except for articles ud for pack-
ing or holding food during cooking
0.85–1.00 ............................. 5.5 pct at 50 °C 11.3 pct at 25 °C
