[Title 21 CFR 177.1580]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 177 - INDIRECT FOOD ADDITIVES: POLYMERS]
[Subpart B - Substances for Use as Basic Components of Single and Repeated]
[Sec. 177.1580 - Polycarbonate resins.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  3
  1996-04-01
  1996-04-01
  false
  
  177.1580
  Sec. 177.1580
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
    FOOD FOR HUMAN CONSUMPTION
    INDIRECT FOOD ADDITIVES: POLYMERS
    Substances for Use as Basic Components of Single and Repeated
  


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'-
isopropylidenediphenol.
    (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 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]