[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 B_Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate
Nitrile rubber modified acrylonitrile-methyl acrylate copolymers
identified in this section may be safely used as components of articles
intended for food-contact use under conditions of use D, E, F, or G
described in table 2 of Sec. 176.170(c) of this chapter, subject to the
provisions of this section.
(a) For the purpose of this section, nitrile rubber modified
acrylonitrile-methyl acrylate copolymers consist of basic copolymers
produced by the graft copolymerization of 73-77 parts by weight of
acrylonitrile and 23-27 parts by weight of methyl acrylate in the
presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers
containing approximately 70 percent by weight of polymer units derived
(b) The nitrile rubber modified acrylonitrile-methyl acrylate basic
copolymers meet the following specifications and extractives
(1) Specifications. (i) Nitrogen content is in the range 16.5-19
percent as determined by Kjeldahl analysis.
(ii) Intrinsic viscosity in acetonitrile at 25 [deg]C is not less
than 0.29 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 reference. Copies 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
(iii) Residual acrylonitrile monomer content is not more than 11
parts per million as determined by gas chromatography.
(iv) Acetonitrile-soluble fraction after refluxing the base polymer
in acetonitrile for 1 hour is not greater than 95 percent by weight of
the basic copolymers.
(2) Extractives limitations. The following extractive limitations
are determined by an infrared spectrophotometric method titled,
``Infrared Spectrophotometric Determination of Polymer Extracted from
Borex [reg] 210 Resin Pellets,'' which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection 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:
regulations/ibr--locations.html.Copies are applicable to the basic
copolymers in the form of particles of a size that will pass through a
U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve
(i) Extracted copolymer not to exceed 2.0 parts per million in
aqueous extract obtained when a 100-gram sample of the basic copolymers
is extracted with 250 milliliters of demineralized (deionized) water at
reflux temperature for 2 hours.
(ii) Extracted copolymer not to exceed 0.5 part per million in n-
heptane extract obtained when a 100-gram sample of the basic copolymers
is extracted with 250 milliliters of reagent grade n-heptane at reflux
temperature for 2 hours.
(c) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(d) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977;
47 FR 11843, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]
Additives that reference this regulation: