[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: 21CFR177.1440]
[Page 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.
(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.
Additives that reference this regulation: |
