Documenti di Didattica
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1630
and under conditions of time and tem- used as provided in 175.105 and 176.210
perature characterizing the conditions of this chapter, and 177.2800. The pro-
of its intended use as determined from visions of paragraph (b) of this section
tables 1 and 2 of 176.170(c) of this chap- are not applicable to oxidized poly-
ter, yields fluoride ion not to exceed 5 ethylene used as provided in 175.125
parts per million calculated on the and 176.170(a)(5) of this chapter and
basis of the volume of food held by the 177.1200.
food-contact article.
177.1630 Polyethylene phthalate
[48 FR 39057, Aug. 29, 1983] polymers.
177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers
Oxidized polyethylene identified in identified in this section may be safely
paragraph (a) of this section may be used as, or components of plastics
safely used as a component of food-con- (films, articles, or fabric) intended for
tact articles, in accordance with the use in contact with food in accordance
following prescribed conditions: with the following prescribed condi-
(a) Oxidized polyethylene is the basic tions:
resin produced by the mild air oxida- (a) Polyethylene phthalate films con-
tion of polyethylene conforming to the sist of a base sheet of ethylene
density, maximum n-hexane extract- terephthalate polymer, ethylene
able fraction, and maximum xylene terephthalate-isophthalate copolymer,
soluble fraction specifications pre- or ethylene-1,4-cyclohexylene
scribed under item 2.3 of the table in dimethylene terephthalate copoly-
177.1520(c). Such oxidized polyethylene esters described in 177.1315(b)(3), to
has a minimum number average molec- which have been added optional sub-
ular weight of 1,200, as determined by stances, either as constituents of the
high temperature vapor pressure os- base sheet or as constituents of coat-
mometry, contains a maximum of 5 ings applied to the base sheet.
percent by weight of total oxygen, and (b) Polyethylene phthalate articles
has an acid value of 9 to 19. consist of a base polymer of ethylene
(b) The finished food-contact article, terephthalate polymer, or ethylene-1,4-
when extracted with the solvent or sol- cyclohexylene dimethylene
vents characterizing the type of food terephthalate copolyesters described in
and under the conditions of time and 177.1315(b)(3), to which have been
temperature characterizing the condi- added optional substances, either as
tions of its intended use as determined constituents of the base polymer or as
from tables 1 and 2 of 176.170(c) of this constituents of coatings applied to the
chapter, yields net acidified chloro- base polymer.
form-soluble extractives not to exceed (c)(1) Polyethylene phthalate
0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of
contact surface when tested by the continuous filaments of ethylene
methods described in 177.1330(c), ex- terephthalate polymer and ethylene
cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer
ble extractives from paper and paper- to which may have been added optional
board complying with 176.170 of this adjuvant substances required in their
chapter may be corrected for wax, pet- preparation and finishing.
rolatum, and mineral oil as provided in (2) The ethylene terephthalate-
176.170(d) (5)(iii)(b) of this chapter. If isophthalate copolymer component of
the finished food-contact article is the fabric shall not exceed 25 percent
itself the subject of a regulation in by weight. The filaments may be blend-
parts 174, 175, 176, 177, 178 and 179.45 of ed with other fibers regulated for the
this chapter, it shall also comply with specific use and the spunbonded fabric
any specifications and limitations pre- may be further bonded by application
scribed for it by such regulations. of heat and/or pressure.
(NOTE: In testing the finished food-con- (3) The fabric shall be used only in
tact article, use a separate test sample accordance with paragraph (i) of this
for each extracting solvent.) section.
erowe on DSK2VPTVN1PROD with CFR
(c) The provisions of this section are (d) The quantity of any optional sub-
not applicable to oxidized polyethylene stance employed in the production of
313
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314
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Food and Drug Administration, HHS 177.1630
Acrylonitrile. formation on the availability of this ma-
Methacrylonitrile. terial at NARA, call 2027416030, or go
Vinyl chloride. to: http://www.archives.gov/
Itaconic acid. federallregister/
Styrene-maleic anhydride resin, partial 2- codeloflfederallregulations/
butoxyethyl ester, ammonium salt (CAS ibrllocations.html.
Reg. No. 68890802). For use only as a coat- The modifier is used at a level not to ex-
ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene
plying with paragraph (a) of this section, terephthalate film. The average thick-
at levels not to exceed 0.025 gram per ness of the finished film shall not exceed
square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch).
inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3-
types VIII and IX in table 1 of 176.170(c) of benzenedimethanamine (CAS Reg. No.
this chapter, under use conditions E, F, 25718701) meeting the specifications in
and G in table 2 of 176.170(c) of this chap- 177.1500(b), item 10, when tested by the
ter. methods given in 177.1500(c). The modi-
fier is used in polyethylene terephthalate
(iv) Emulsifiers: at a level not to exceed 30 percent by
Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene
juvant in the application of coatings to the terephthalate.
base sheet or base polymer. Chloroform-soluble extractives shall not
Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5
application of coatings to the base sheet or milligram/inch2) of food-contact surface
base polymer. of the modified polyethylene
2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to
Reg. No. 1804871). For use only in copoly- the following solvents at temperatures
mer coatings on polyethylene phthalate and times indicated:
film under conditions of use E, F, and G de- (a) Distilled water at 49 C (120 F) for 24
scribed in table 2 of 175.300(d) of this chap- hours;
ter, and limited to use at a level not to ex- (b) n-Heptane at 49 C (120 F) for 24 hours;
ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 C (120 F)
polymer coating. for 24 hours.
For use in contact with all types of foods
(v) Modifier: except (a) those containing more than 8
1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera-
polymer with 1,4-butanediol and a-hydro- tures over 49 C (120 F).
omega-hydroxypoly(oxy-1,4-butanediyl)
CAS Reg. No. 9078711) meeting the fol- (f) Polyethylene phthalate plastics
lowing specifications: conforming with the specifications pre-
Melting point: 200 to 215 C as determined scribed in paragraph (f)(1) of this sec-
by ASTM method D211782, Standard tion are used as provided in paragraph
Test Method for Melting Point of (f)(2) of this section:
Semicrystalline Polymers by the Hot
(1) Specifications. (i) The food contact
Stage Microscopy Method, which is in-
corporated by reference. Copies may be surface, when exposed to distilled
obtained from the American Society for water at 250 F for 2 hours, yields chlo-
Testing Materials, 100 Barr Harbor Dr., roform-soluble extractives not to ex-
West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface
19428-2959, or may be examined at the Na- exposed to the solvent; and
tional Archives and Records Administra- (ii) The food contact surface, when
tion (NARA). For information on the exposed to n-heptane at 150 F for 2
availability of this material at NARA, hours, yields chloroform-soluble ex-
call 2027416030, or go to: http://
www.archives.gov/federallregister/
tractives not to exceed 0.5 mg/in2 of
codeloflfederallregulations/ food contact surface exposed to the sol-
ibrllocations.html. vent.
Density: 1.15 to 1.20 as determined by ASTM (2) Conditions of use. The plastics are
method D150568 (Reapproved 1979), used for packaging, transporting, or
Standard Test Method for Density of holding food, excluding alcoholic bev-
Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed
nique, which is incorporated by ref- 250 F.
erence. Copies may be obtained from the
(g) Polyethylene phthalate plastics
American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken, conforming with the specifications pre-
scribed in paragraph (g)(1) of this sec-
erowe on DSK2VPTVN1PROD with CFR
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