[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1380]

[Page 254-255]
 
                        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.

[[Page 255]]

    (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 Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.
    (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-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]