[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: 21CFR177.1320]
[Page 260-261]
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. 177.1320 Ethylene-ethyl acrylate copolymers.
Ethylene-ethyl acrylate copolymers may be safely used to produce
packaging materials, containers, and equipment intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
following prescribed conditions:
(a) Ethylene-ethyl acrylate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and ethyl
acrylate, to which may have been added certain optional substances to
impart desired technological properties to the resin. Subject to any
limitations prescribed in this section, the optional substances may
include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(b) The ethyl acrylate content of the copolymer does not exceed 8
percent by
[[Page 261]]
weight unless it is blended with polyethylene or with one or more olefin
copolymers complying with Sec. 177.1520 or with a mixture of
polyethylene and one or more olefin copolymers, in such proportions that
the ethyl acrylate content of the blend does not exceed 8 percent by
weight, or unless it is used in a coating complying with Sec. 175.300
or Sec. 176.170 of this chapter, in such proportions that the ethyl
acrylate content does not exceed 8 percent by weight of the finished
coating.
(c) Ethylene-ethyl acrylate copolymers or the blend shall conform to
the specifications prescribed in paragraph (c)(1) of this section and
shall meet the ethyl acrylate content limits prescribed in paragraph (b)
of this section, and the extractability limits prescribed in paragraph
(c)(2) of this section, when tested by the methods prescribed for
polyethylene in Sec. 177.1520.
(1) Specifications--(i) Infrared identification. Ethylene-ethyl
acrylate copolymers can be identified by their characteristic infrared
spectra.
(ii) Quantitative determination of ethyl acrylate content. The ethyl
acrylate can be determined by the infrared spectra. Prepare a scan from
10.5 microns to 12.5 microns. Obtain a baseline absorbance at 11.6
microns and divide by the plaque thickness to obtain absorbance per mil.
From a previously prepared calibration curve, obtain the amount of ethyl
acrylate present.
(iii) Specific gravity. Ethylene-ethyl acrylate copolymers have a
specific gravity of not less than 0.920 nor more than 0.935, as
determined by ASTM method D1505-68 (Reapproved 1979), ``Standard Test
Method for Density of Plastics by the Density-Gradient Technique,''
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 to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may
be used in contact with food except as a component of articles used for
packaging or holding food during cooking provided they meet the
following extractability limits:
(i) Maximum soluble fraction of 11.3 percent in xylene after
refluxing and subsequent cooling to 25 [deg]C.
(ii) Maximum extractable fraction of 5.5 percent when extracted with
n-hexane at 50 [deg]C.
(d) The provisions of paragraphs (b) and (c)(2) of this section are
not applicable to ethylene-ethyl acrylate copolymers used in the
formulation of adhesives complying with Sec. 175.105 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19, 1984]
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