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[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: 21CFR177.2355]

[Page 337]
 
                        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.  177.2355  Mineral reinforced nylon resins.

    Mineral reinforced nylon resins identified in paragraph (a) of this 
section may be safely used as articles or components of articles 
intended for repeated use in contact with nonacidic food (pH above 5.0) 
and at use temperatures not exceeding 212 [deg]F. in accordance with the 
following prescribed conditions:
    (a) For the purpose of this section the mineral reinforced nylon 
resins consist of nylon 66, as identified in and complying with the 
specifications of Sec.  177.1500, reinforced with up to 40 weight 
percent of calcium silicate and up to 0.5 weight percent 3-
(triethoxysilyl) propylamine (Chemical Abstracts Service Registry No. 
000919302) based on the weight of the calcium silicate.
    (b) The mineral reinforced nylon resins may contain up to 0.2 
percent by weight of titanium dioxide as an optional adjuvant substance.
    (c) The mineral reinforced nylon resins with or without the optional 
substance described in paragraph (b) of this section, and in the form of 
\1/8\-inch molded test bars, when extracted with the solvents, i.e., 
distilled water and 50 percent (by volume) ethyl alcohol in distilled 
water, at reflux temperature for 24 hours using a volume-to-surface 
ratio of 2 milliliters of solvent per square inch of surface tested, 
shall meet the following extractives limitations:
    (1) Total extractives not to exceed 5.0 milligrams per square inch 
of food-contact surface tested for each solvent.
    (2) The ash after ignition of the extractives described in paragraph 
(c)(1) of this section, not to exceed 0.5 milligram per square inch of 
food-contact surface tested.
    (d) In accordance with good manufacturing practice, finished 
articles containing the mineral reinforced nylon resins shall be 
thoroughly cleansed prior to their first use in contact with food.

[42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]




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