[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1345]
[Page 265-266]
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. 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/
terephthalate copolymer.
Ethylene/1, 3-phenylene oxyethylene isophthalate/terephthalate
copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this
section may be safely used, subject to the provisions of this section,
as the non-food-contact layer of laminate structures subject to the
provisions of Sec. 177.1395, and in blends with polyethylene
terephthalate polymers complying with Sec. 177.1630.
(a) Identity. For the purpose of this section, ethylene/1,3-
phenylene oxyethylene isophthalate/terephthalate copolymer consists of
the basic copolymer produced by the catalytic polycondensation of
isophthalic acid and terephthalic acid with ethylene glycol and 1,3-
bis(2-hydroxyethoxy)benzene such that the finished resin contains
between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8
mole-percent of terephthalic moieties, and not more than 10 mole-percent
of 1,3-bis(2-hydroxyethoxy)benzene moieties.
(b) Specifications--(1) Density. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer identified in paragraph (a) of this
section has a density of 1.330.02 grams per cubic
centimeter measured by ASTM Method D 1505-85 (Reapproved 1990),
``Standard Test Method for Density of Plastics by the Density-Gradient
Technique,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the
American Society for Testing and Materials, 100 Barr
[[Page 266]]
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, and 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: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
(2) Softening point. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer identified in paragraph (a) of this
section has a softening point of 635 [deg]C as
measured by ASTM Method D 1525-87, ``Standard Test Method for VICAT
Softening Temperature of Plastics,'' which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability
of this material is provided in paragraph (b)(1) of this section.
(c) Optional adjuvant substances. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer, identified in paragraph (a) of
this section, may contain optional adjuvant substances required in their
production. The optional adjuvants may include substances used in
accordance with Sec. 174.5 of this chapter.
(d) Limitations. Copolymer blends described above shall not exceed
30 percent by weight of ethylene/1, 3-phenylene oxyethylene
isophthalate/terephthalate copolymer. The finished blend may be used in
contact with food only under conditions of use C through G, as described
in table 2 of Sec. 176.170(c) of this chapter, except that with food
identified as Type III, IV-A, V, VII-A, and IX in Sec. 176.170(c),
table 1, the copolymer may be used under condition of use C at
temperatures not to exceed 160 [deg]F (71 [deg]C).
[57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994;
61 FR 14481, Apr. 2, 1996; 62 FR 34628, June 27, 1997]
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