[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1320]

[Page 254-255]
 
                        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 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

[[Page 255]]

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, 1916 Race St., Philadelphia, PA 
19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (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]