[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1380]
[Page 269-270]
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. 177.1380 Fluorocarbon resins.
Fluorocarbon resins may be safely used as articles or components of
articles intended for use in contact with food, in accordance with the
following prescribed conditions:
(a) For the purpose of this section, fluorocarbon resins consist of
basic resins produced as follows:
(1) Chlorotrifluoroethylene resins produced by the
homopolymerization of chlorotrifluoroethylene.
(2) Chlorotrifluoroethylene.1,1-difluoroethylene copolymer resins
produced by copolymerization of chlorotrifluoroethylene and 1,1-
difluoroethylene.
(3) Chlorotrifluoroethylene.1,1-difluoroethylene-tetrafluoroethylene
co-polymer resins produced by copolymerization of
chlorotrifluoroethylene, 1,1-difluoroethylene, and tetrafluoroethylene.
(4) Ethylene-chlorotrifluoroethylene copolymer resins produced by
copolymerization of nominally 50 mole percent of ethylene and 50 mole
percent of chlorotrifluoroethylene. The copolymer shall have a melting
point of 239 to 243 [deg]C and a melt index of less than or equal to 20
as determined by ASTM Method D 3275-89 ``Standard Specification for E-
CTFE-Fluoroplastic Molding, Extrusion, and Coating Materials,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the American Society for Testing
and Materials, 1916 Race St., Philadelphia, PA 19013, or may be examined
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
(b) Fluorocarbon resins that are identified in paragraph (a) of this
section and that comply with extractive limitations prescribed in
paragraph (c) of this section may be used as articles or components of
articles intended for use in contact with food as follows:
(1) Fluorocarbon resins that are identified in paragraphs (a)(1),
(a)(2), and (a)(3) of this section and that comply only with the
extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of
this section may be used when such use is limited to articles or
components of articles that are intended for repeated use in contact
with food or that are intended for one-time use in contact with foods
only of the types identified in Sec. 176.170(c) of this chapter, table
1, under Types I, II, VI, VII-B, and VIII.
(2) Fluorocarbon resins that are identified in paragraph (a)(4) of
this section and that comply with the extractive limitations prescribed
in paragraphs (c)(1) and (c)(2) of this section may be used only when
such use is limited to articles or components of articles that are
intended for repeated use in contact with food.
(3) In accordance with current good manufacturing practice, those
food-
[[Page 270]]
contact articles intended for repeated use shall be thoroughly cleansed
prior to their first use in contact with food.
(c) Extractives limitations are applicable to the basic resins in
the form of pellets that have been 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.
(1) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of distilled water at reflux temperature for 8 hours, shall
yield total extractives not to exceed 0.003 percent by weight of the
resins.
(2) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of 50 percent (by volume) ethyl alcohol in distilled water
at reflux temperature for 8 hours, shall yield total extractives not to
exceed 0.003 percent by weight of the resins.
(3) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of n-heptane at reflux temperature for 8 hours, shall yield
total extractives not to exceed 0.01 percent by weight of the resins.
[42 FR 14572, Mar. 15, 1977, as amended at 57 FR 185, Jan. 3, 1992]
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