[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1440]

[Page 274-275]
 
                        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. 177.1440  4,4'-Isopropylidenediphenol-epichlorohydrin resins 
minimum molecular weight 10,000.

    4,4'-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum 
molecular weight of 10,000 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) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins consist of 
basic resins produced by the condensation of equimolar amounts of 4,4'-
isopropylidenediphenol and epichlorohydrin terminated with phenol, to 
which may have been added certain optional adjuvant substances required 
in the production of the resins.

[[Page 275]]

    (b) The optional adjuvant substances required in the production of 
the resins 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
------------------------------------------------------------------------
Butyl alcohol............................  Not to exceed 300 p.p.m. as
                                            residual solvent in finished
                                            resin.
Ethyl alcohol............................
Toluene..................................  Not to exceed 1,000 p.p.m. as
                                            residual solvent in finished
                                            resin.
------------------------------------------------------------------------

    (c) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet 
the following nonvolatile extractives limitations:
    (1) Maximum extractable nonvolatile fraction of 2 parts per million 
when extracted with distilled water at 70 [deg]C for 2 hours, using a 
volume-to-surface ratio of 2 milliliters per square inch.
    (2) Maximum extractable nonvolatile fraction of 3 parts per million 
when extracted with n-heptane at 70 [deg]C for 2 hours, using a volume-
to-surface ratio of 2 milliliters per square inch.
    (3) Maximum extractable nonvolatile fraction of 6 parts per million 
when extracted with 10 percent (by volume) ethyl alcohol in distilled 
water at 70 [deg]C for 2 hours, using a volume-to-surface ratio of 2 
milliliters per square inch.
    (d) The provisions of this section are not applicable to 4,4'-
isopropylidene-diphenol-epichlorohydrin resins listed in other sections 
of subchapter B of this chapter.