[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: 21CFR177.1350]
[Page 266-267]
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. 177.1350 Ethylene-vinyl acetate copolymers.
Ethylene-vinyl acetate copolymers may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food in accordance with the following prescribed conditions:
(a)(1) Ethylene-vinyl acetate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and vinyl acetate
to which may have been added certain optional substances to impart
desired technological or physical properties to the resin. Subject to
any limitations prescribed in this section, the optional substances may
include:
(i) Substances generally recognized as safe in food and food
packaging.
(ii) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(iii) Substances identified in Sec. 175.300(b)(3) (xxv), (xxvii),
(xxx), and (xxxiii) of this chapter, and colorants used in accordance
with Sec. 178.3297 of this chapter.
(iv) Erucamide as identified in Sec. 178.3860 of this chapter.
(v) Xanthan gum as identified in Sec. 172.695 for use as a
thickening agent at a level not to exceed 1 percent by weight of coating
solids in aqueous dispersions of ethylene-vinyl acetate copolymers,
where such copolymers are used only as coatings or a component of
coatings.
(vi) The copolymer of vinylidene fluoride and hexafluoropropene (CAS
Reg. No. 9011.17-0), containing 65 to 71 percent fluorine and having a
Mooney Viscosity of at least 28, for use as a processing aid at a level
not to exceed 0.2 percent by weight of ethylene-vinyl acetate
copolymers.
(2) Maleic anhydride-grafted ethylene-vinyl acetate copolymers (CAS
Reg. No. 28064-24-6) consist of basic resins produced by the catalytic
copolymerization of ethylene and vinyl acetate, followed by reaction
with maleic anhydride. Such polymers shall contain not more than 11
percent of polymer units derived from vinyl acetate by weight of total
polymer prior to reaction with maleic anhydride, and not more than 2
percent of grafted maleic anhydride by weight of the finished polymer.
Optional adjuvant substances that may be
[[Page 267]]
added to the copolymers include substances generally recognized as safe
in food and food packaging, substances the use of which is permitted
under applicable regulations in parts 170 through 189 of this chapter,
and substances identified in Sec. 175.300(b)(3)(xxv), (xxvii),
(xxxiii), and (xxx) of this chapter and colorants for polymers used in
accordance with the provisions of Sec. 178.3297 of this chapter.
(b)(1) Ethylene-vinyl acetate copolymers, with or without the
optional substances described in paragraph (a) of this section, when
extracted with the solvent or solvents characterizing the type of food,
and under conditions of time and temperature characterizing the
conditions of their intended use as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble
extractives corrected for zinc as zinc oleate not to exceed 0.5
milligram per square inch of an appropriate sample.
(2) Maleic anhydride grafted ethylene-vinyl acetate copolymers shall
have a melt flow index not to exceed 2.1 grams per 10 minutes as
determined by ASTM method D 1238-82, ``Standard Test Method for Flow
Rates of Thermoplastics by Extrusion Plastometer,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may
be obtained from the American Society for Testing Materials, 100 Barr
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or at the
Division of Petition Control (HFS-215), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or 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. Compliance of the
melt flow index specification shall be determined using conditions and
procedures corresponding to those described in the method as Condition
E, Procedure A). The copolymers shall be used in blends with other
polymers at levels not to exceed 17 percent by weight of total polymer,
subject to the limitation that when contacting food of types III, IV-A,
V, VI-C, VII-A, and IX, identified in Sec. 176.170(c) of this chapter,
Table 1, the polymers shall be used only under conditions of use C, D,
E, F, and G, described in Sec. 176.170(c) of this chapter, Table 2.
(c) The provisions of paragraph (b) of this section are not
applicable to ethylene-vinyl acetate copolymers used in food-packaging
adhesives complying with Sec. 175.105 of this chapter.
(d) Ethylene-vinyl acetate copolymers may be irradiated under the
following conditions to produce molecular crosslinking of the polymers
to impart desired properties such as increased strength and increased
ability to shrink when exposed to heat:
(1) Electron beam source of ionizing radiation at a maximum energy
of 3 million electron volts: Maximum absorbed dose not to exceed 150
kiloGray (15 megarads).
(2) The finished food-contact film shall meet the extractives
limitations prescribed in paragraph (e)(2) of this section.
(3) The ethylene-vinyl acetate copolymer films may be further
irradiated in accordance with the provisions of paragraph (e)(1) of this
section: Provided, That the total accumulated radiation dose from both
electron beam and gamma ray radiation does not exceed 150 kiloGray (15
megarads).
(e) Ethylene-vinyl acetate copolymer films intended for contact with
food may be irradiated to control the growth of microorganisms under the
following conditions:
(1) Gamma photons emitted from a cobalt-60 sealed source in the dose
range of 5-50 kiloGray (0.5-5.0 megarads).
(2) The irradiated ethylene-vinyl acetate copolymer films, when
extracted with reagent grade n-heptane (freshly redistilled before use)
according to methods described under Sec. 176.170(d)(3) of this
chapter, at 75 [deg]F for 30 minutes shall yield total extractives not
to exceed 4.5 percent by weight of the film.
[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54
FR 35874, Aug. 30, 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30,
1991; 64 FR 47108, Aug. 30, 1999]
[[Page 268]]
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