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177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.

Home > Regulations > Indirect food additives: Polymers > 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.



[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: 21CFR177.2460]

[Page 342-343]
 
                        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 C_Substances for Use Only as Components of Articles Intended for 
                              Repeated Use
 
Sec.  177.2460  Poly(2,6-dimethyl-1,4-phenylene) oxide resins.

    The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in 
paragraph (a) of this section may be used as an article or as a 
component of an article intended for use in contact with food subject to 
the provisions of this section.
    (a) Identity. For the purposes of this section, poly(2,6-dimethyl-
1,4-phenylene) oxide resins consist of basic resins produced by the 
oxidative coupling of 2,6-xylenol such that the finished basic resins 
meet the specifications and extractives limitations prescribed in 
paragraph (c) of this section.
    (b) Optional adjuvant substances. The basic poly(2,6-dimethyl-1,4-
phenylene) oxide resins identified in paragraph (a) of this section may 
contain optional adjuvant substances required in the production of such 
basic resins. The optional adjuvant substances required in the 
production of the basic poly(2,6-dimethyl-1,4-phenylene) oxide resins 
may include substances permitted for such use by regulations in parts 
170 through 189 of this chapter, substances generally recognized as safe 
in food, substances used in accordance with a prior sanction or 
approval, and the following:

------------------------------------------------------------------------
                                              Limitations (expressed as
            List of substances                  percent by weight of
                                                finished basic resin)
------------------------------------------------------------------------
Diethylamine..............................  Not to exceed 0.16 percent
                                             as residual catalyst.
Methyl alcohol............................  Not to exceed 0.02 percent
                                             as residual solvent.
Toluene...................................  Not to exceed 0.2 percent as
                                             residual solvent.
------------------------------------------------------------------------

    (c) Specifications and extractives limitations. The poly(2,6-
dimethyl-1,4-phenylene) oxide basic resins meet the following:
    (1) Specifications. Intrinsic viscosity is not less than 0.30 
deciliter per gram as determined by ASTM method D1243-79, ``Standard 
Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,'' 
which is incorporated by

[[Page 343]]

reference, modified as follows. Copies of the incorporation by reference 
may be obtained from the American Society for Testing 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.
    (i) Solvent: Chloroform, reagent grade containing 0.01 percent tert-
butylcatechol.
    (ii) Resin sample: Powdered resin obtained from production prior to 
molding or extrusion.
    (iii) Viscometer: Cannno-Ubbelohde series 25 dilution viscometer (or 
equivalent).
    (iv) Calculation: The calculation method used is that described in 
appendix X.1.3 (ASTM method D1243-79, cited and incorporated by 
reference in paragraph (c)(1) of this section) with the reduced 
viscosity determined for three concentration levels (0.4, 0.2, and 0.1 
gram per deciliter) and extrapolated to zero concentration for 
intrinisic viscosity. The following formula is used for determining 
reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.406

where:

t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.

    (2) Extractives limitations. Total resin extracted not to exceed 
0.02 weight-percent when extracted with n-heptane at 160 [deg]F for 2 
hours as determined using 200 milliliters of reagent grade n-heptane 
which has been freshly distilled before use and 25 grams of poly (2,-6-
dimethyl-1,4-phenylene) oxide resin. The resin as tested is in pellet 
form having a particle size such that 100 percent of the pellets will 
pass through a U.S. Standard Sieve No. 6 and 100 percent of the pellets 
will be held on a U.S. Standard Sieve No. 10.
    (d) Other limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide 
resins identified in and complying with this section, when used as 
components of the food-contact surface of any article that is the 
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec.  
179.45 of this chapter, shall comply with any specifications and 
limitations prescribed by such regulation for the article in the 
finished form in which it is to contact food.
    (e) Uses. The poly(2,6-dimethyl-1,4-phenylene) oxide resins 
identified in and complying with the limitations in this section may be 
used as articles or components of articles intended for repeated food-
contact use or as articles or components of articles intended for 
single-service food-contact use only under the conditions described in 
Sec.  176.170(c) of this chapter, table 2, conditions of use H.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 
63 FR 8852, Feb. 23, 1998]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 2460


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