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177.1350 Ethylene-vinyl acetate copolymers.

Home > Regulations > Indirect food additives: Polymers > 177.1350 Ethylene-vinyl acetate copolymers.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1350]

[Page 265-266]
 
                        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 266]]

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 267]]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1350


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