[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: 21CFR177.1580]
[Page 302-303]
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. 177.1580 Polycarbonate resins.
Polycarbonate resins may be safely used as articles or components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, in accordance with the following prescribed conditions:
(a) Polycarbonate resins are polyesters produced by:
(1) The condensation of 4,4'-iso-propylidenediphenol and carbonyl
chloride to which may have been added certain optional adjuvant
substances required in the production of the resins; or by
(2) The reaction of molten 4,4'-iso-propylidenediphenol with molten
diphenyl carbonate in the presence of the disodium salt of 4,4'-isopro
pylidenediphenol.
(3) The condensation of 4,4'-isopro- pylidenediphenol, carbonyl
chloride, and 0.5 percent weight maximum of a2,a6-bis (6-hydroxy-m-
tolyl) mesitol to which may have been added certain optional adjuvant
substances required in the production of branched polycarbonate resins.
(b) The optional adjuvant substances required in the production of
resins produced by the methods described in
[[Page 303]]
paragraph (a)(1) and (3) of this section may include substances
generally recognized as safe in food, substances used in accordance with
a prior sanction or approval, and the following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
p-tert-Butylphenol........................ ............................
Chloroform................................ ............................
p-Cumylphenol (CAS Reg. No. 599-64-4)..... For use only as a chain
terminator at a level not
to exceed 5 percent by
weight of the resin.
Ethylene dichloride.......................
Heptane...................................
Methylene chloride........................
Monochlorobenzene......................... Not to exceed 500 p.p.m. as
residual solvent in
finished resin.
Pentaerythritol tetrastearate (CAS Reg. For use only as a mold
No. 115-83-3). release agent, at a level
not to exceed 0.5 percent
by weight of the finished
resin.
Phenol (CAS Reg. No. 108-95-2)............
Pyridine..................................
Toluene: (CAS Reg. No. 108-88-3).......... Not to exceed 800 parts per
million as residual solvent
in finished resin.
Triethylamine.............................
------------------------------------------------------------------------
(c) Polycarbonate resins shall conform to the specification
prescribed in paragraph (c)(1) of this section and shall meet the
extractives limitations prescribed in paragraph (c)(2) of this section.
(1) Specification. Polycarbonate resins can be identified by their
characteristic infrared spectrum.
(2) Extractives limitations. The polycarbonate 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 a U.S. standard sieve
No. 10.
(i) Polycarbonate resins, when extracted with distilled water at
reflux temperature for 6 hours, shall yield total extractives not to
exceed 0.15 percent by weight of the resins.
(ii) Polycarbonate resins, when extracted with 50 percent (by
volume) ethyl alcohol in distilled water at reflux temperature for 6
hours, shall yield total extractives not to exceed 0.15 percent by
weight of the resins.
(iii) Polycarbonate resins, when extracted with n-heptane at reflux
temperature for 6 hours, shall yield total extractives not to exceed
0.15 percent by weight of the resins.
[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981;
49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug.
8, 1988; 59 FR 43731, Aug. 25, 1994]
Additives that reference this regulation: |
