[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 177_INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart C_Substances for Use Only as Components of Articles Intended for
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]
Additives that reference this regulation: