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177.1585 Polyestercarbonate resins.

Home > Regulations > Indirect food additives: Polymers > 177.1585 Polyestercarbonate resins.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1585


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