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177.1580 Polycarbonate resins.

Home > Regulations > Indirect food additives: Polymers > 177.1580 Polycarbonate 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: 21CFR177.1580]

[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1580


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