[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: 21CFR177.1560]
[Page 302]
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. 177.1560 Polyarylsulfone resins.
Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used
as articles or components of articles intended for use in contact with
food, at temperatures up to and including normal baking temperatures, in
accordance with the following prescribed conditions:
(a) Identity. Polyarylsulfone resins are copolymers containing not
more than 25 percent of oxy-p-phenylene-oxy-p-phenylenesulfonyl-p-
phenylene polymer units and not less than 75 percent of oxy-p-
phenylenesulfonyl-p-phenylene-oxy-p-phenylenesulfonyl-p-phenylene
polymer units. The copolymers have a minimum reduced viscosity of 0.40
deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM
method D2857-70 (Reapproved 1977), ``Standard Test Method for Dilute
Solution Viscosity of Polymers,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing and
Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, 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) Optional adjuvant substances. The basic polyarylsulfone resins
identified in paragraph (a) of this section may contain optional
adjuvant substances required in the production of such basic copolymers.
These optional adjuvant substances may include substances permitted for
such use by regulations in parts 170 through 179 of this chapter,
substances generally recognized as safe in food, substances used in
accordance with a prior sanction of approval, and substances named in
this paragraph and further identified as required:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Sulfolane......................... Not to exceed 0.15 percent as
residual solvent in the finished
basic resin.
------------------------------------------------------------------------
(c) Extractive limitations. The finished polyarylsulfone resin when
extracted for 2 hours with the following solvents at the specified
temperatures yields total extractives in each extracting solvent not to
exceed 0.008 milligram per square centimeter of food-contact surface:
distilled water at 121 [deg]C (250 [deg]F), 50 percent (by volume) ethyl
alcohol in distilled water at 71.1 [deg]C (160 [deg]F), 3 percent acetic
acid in distilled water at 100 [deg]C (212 [deg]F), and n-heptane at
65.6 [deg]C (150 [deg]F).
Note: In testing the finished poly aryl sulfone resin use a separate
test sample for each required extracting solvent.
[50 FR 31046, July 24, 1985]
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