[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1585]
[Page 303-304]
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. 177.1585 Polyestercarbonate resins.
Polyestercarbonate resins may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, or holding food, in
accordance with the following prescribed conditions:
(a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced
by the condensation of 4,4'-isopropylidenediphenol, carbonyl chloride,
terephthaloyl chloride, and isophthaloyl chloride such that the finished
resins are composed of 45 to 85 molepercent ester, of which up to 55
mole-percent is the terephthaloyl isomer. The resins are manufactured
using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1
and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or
greater. The resins are also properly identified by CAS Reg. No. 114096-
64-9 when produced with the use of greater than 2 but not greater than 5
weight percent p-cumylphenol (CAS Reg. No. 599-64-4), as an optional
adjuvant substance in accordance with paragraph (b)(2) of this section.
(b) Optional adjuvants. The optional adjuvant substances required in
the production of resins identified in paragraph (a) of this section may
include:
(1) Substances used in accordance with Sec. 174.5 of this chapter.
(2) Substances identified in Sec. 177.1580(b).
(3) Substances regulated in Sec. 178.2010(b) of this chapter for
use in polycarbonate resins complying with Sec. 177.1580:
Provided, That the substances are used in accordance with any limitation
on concentration, conditions of use, and food types specified in Sec.
178.2010(b) of this chapter.
[[Page 304]]
(c) Polyestercarbonate resins shall conform to the specifications
prescribed in paragraph (c)(1) of this section and shall meet the
extractive limitations prescribed in paragraph (c)(2) of this section.
(1) Specifications. Polyestercarbonate resins identified in
paragraph (a) of this section can be identified by their characteristic
infrared spectrum. The resins shall comply with either or both of the
following specifications:
(i) The solution intrinsic viscosity of the polyestercarbonate
resins shall be a minimum of 0.44 deciliter per gram, as determined by a
method entitled ``Intrinsic Viscosity (IV) of Lexan [reg]
Polyestercarbonate Resin by a Single Point Method Using Dichloromethane
as the Solvent,'' developed by the General Electric Co., September 20,
1985, 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-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, 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, 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: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(ii) A minimum weight-average molecular weight of 27,000, as
determined by gel permeation chromatography using polystyrene standards.
(2) Extractives limitations. The polyestercarbonate resins to be
tested shall be ground or cut into small particles that will pass
through a U.S. standard sieve No. 6 and that will be held on U.S.
standard sieve No. 10.
(i) Polyestercarbonate resins, when extracted with distilled water
at reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.005 percent by weight of the resins.
(ii) Polyestercarbonate resins, when extracted with 50 percent (by
volume) ethyl alcohol in distilled water at reflux temperature for 6
hours, shall yield total nonvolatile extractives not to exceed 0.005
percent by weight of the resins.
(iii) Polyestercarbonate resins, when extracted with n-heptane at
reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.002 percent by weight of the resins.
(3) Residual methylene chloride levels in poly ester carbonate
resins. Poly ester carbonate resin articles in the finished form shall
not contain residual methylene chloride in excess of 5 parts per million
as determined by a method titled ``Analytical Method for Determination
of Residual Methylene Chloride in Polyestercarbonate Resin,'' developed
by the General Electric Co., July 23, 1991, 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 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.
[57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999]
Additives that reference this regulation: |
