[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: 21CFR179.45]
[Page 454-456]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 179_IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
--Table of Contents
Subpart C_Packaging Materials for Irradiated Foods
Sec. 179.45 Packaging materials for use during the irradiation
of prepackaged foods.
The packaging materials identified in this section may be safely
subjected to irradiation incidental to the radiation treatment and
processing of prepackaged foods, subject to the provisions of this
section and to the requirement that no induced radioactivity is
detectable in the packaging material itself:
(a) The radiation of the food itself shall comply with regulations
in this part.
(b) The following packaging materials may be subjected to a dose of
radiation, not to exceed 10 kilograys, unless otherwise indicated,
incidental to the use of gamma, electron beam, or X-radiation in the
radiation treatment of prepackaged foods:
(1) Nitrocellulose-coated or vinylidene chloride copolymer-coated
cellophane complying with Sec. 177.1200 of this chapter.
(2) Glassine paper complying with Sec. 176.170 of this chapter.
(3) Wax-coated paperboard complying with Sec. 176.170 of this
chapter.
(4) Polyolefin film prepared from one or more of the basic olefin
polymers complying with Sec. 177.1520 of this chapter. The finished
film may contain:
(i) Adjuvant substances used in compliance with Sec. Sec. 178.3740
and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl
sulfate, polyvinyl chloride, and materials as listed in paragraph
(d)(2)(i) of this section.
(ii) Coatings comprising a vinylidene chloride copolymer containing
a minimum of 85 percent vinylidene chloride with one or more of the
following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl
acrylate, and methyl methacrylate.
(5) Kraft paper prepared from unbleached sulfate pulp to which
rosin, complying with Sec. 178.3870 of this chapter, and alum may be
added. The kraft paper is used only as a container for flour and is
irradiated with a dose not exceeding 500 grays.
(6) Polyethylene terephthalate film prepared from the basic polymer
as described in Sec. 177.1630(e)(4)(i) and (ii) of
[[Page 455]]
this chapter. The finished film may contain:
(i) Adjuvant substances used in compliance with Sec. Sec. 178.3740
and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl
sulfate, polyvinyl chloride, and materials as listed in paragraph
(d)(2)(i) of this section.
(ii) Coatings comprising a vinylidene chloride copolymer containing
a minimum of 85 percent vinylidene chloride with one or more of the
following comonomers: Acrylic acid, acrylonitrile, itaconic acid, methyl
acrylate, and methyl methacrylate.
(iii) Coatings consisting of polyethylene conforming to Sec.
177.1520 of this chapter.
(7) Polystyrene film prepared from styrene basic polymer. The
finished film may contain adjuvant substances used in compliance with
Sec. Sec. 178.3740 and 181.22 through 181.30 of this chapter.
(8) Rubber hydrochloride film prepared from rubber hydrochloride
basic polymer having a chlorine content of 30-32 weight percent and
having a maximum extractable fraction of 2 weight percent when extracted
with n-hexane at reflux temperature for 2 hours. The finished film may
contain adjuvant substances used in compliance with Sec. Sec. 178.3740
and 181.22 through 181.30 of this chapter.
(9) Vinylidene chloride-vinyl chloride copolymer film prepared from
vinylidene chloride-vinyl chloride basic copolymers containing not less
than 70 weight percent of vinylidene chloride and having a viscosity of
0.50-1.50 centipoises as determined by ASTM method D729-81, ``Standard
Specification for Vinylidene Chloride Molding Compounds,'' 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. The finished film may contain adjuvant substances used
in compliance with Sec. Sec. 178.3740 and 181.22 through 181.30 of this
chapter.
(10) Nylon 11 conforming to Sec. 177.1500 of this chapter.
(c) Ethylene-vinyl acetate copolymers complying with Sec. 177.1350
of this chapter. The ethylene-vinyl acetate packaging materials may be
subjected to a dose of radiation, not to exceed 30 kilogray (3
megarads), incidental to the use of gamma, electron beam, or X-radiation
in the radiation treatment of packaged foods.
(d) The following packaging materials may be subjected to a dose of
radiation, not to exceed 60 kilograys incidental to the use of gamma,
electron beam, or X-radiation in the radiation processing of prepackaged
foods:
(1) Vegetable parchments, consisting of a cellulose material made
from waterleaf paper (unsized) treated with concentrated sulfuric acid,
neutralized, and thoroughly washed with distilled water.
(2) Films prepared from basic polymers and with or without
adjuvants, as follows:
(i) Polyethylene film prepared from the basic polymer as described
in Sec. 177.1520(a) of this chapter. The finished film may contain one
or more of the following added substances:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Amides of erucic, linoleic, oleic, Not to exceed 1 pct by weight
palmitic, and stearic acid. of the polymer.
BHA as described in Sec. 172.110 of Do.
this chapter.
BHT as described in Sec. 172.115 of Do.
this chapter.
Calcium and sodium propionates......... Do.
Petroleum wax as described in Sec. Do.
178.3710 of this chapter.
Polypropylene, noncrystalline, as Not to exceed 2 pct by weight
described in Sec. 177.1520(c) of of the polymer.
this chapter.
Stearates of aluminum, calcium, Not to exceed 1 pct by weight
magnesium, potassium, and sodium as of the polymer.
described in Sec. 172.863(a) of this
chapter.
Triethylene glycol as described in Sec. Do.
178.3740(b) of this chapter.
Mineral oil as described in Sec. Do.
178.3620 (a) or (b) of this chapter.
------------------------------------------------------------------------
[[Page 456]]
(ii) Polyethylene terephthalate film prepared from the basic polymer
as described in Sec. 177.1630(e)(4)(ii) of this chapter. The finished
film may contain one or more of the added substances listed in paragraph
(d)(2)(i) of this section.
(iii) Nylon 6 films prepared from the nylon 6 basic polymer as
described in Sec. 177.1500(a)(6) of this chapter and meeting the
specifications of item 6.1 of the table in Sec. 177.1500(b) of this
chapter. The finished film may contain one or more of the added
substances listed in paragraph (d)(2)(i) of this section.
(iv) Vinyl chloride-vinyl acetate copolymer film prepared from the
basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride
with 10.0 to 11.5 weight percent of vinyl acetate and having a maximum
volatility of not over 3.0 percent (1 hour at 105 [deg]C) and viscosity
not less than 0.30 determined by ASTM method D1243-79, ``Standard Test
Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,''
Method A, which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(9) of this section.
The finished film may contain one or more of the added substances listed
in paragraph (d)(2)(i) of this section.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984;
54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, Mar.
29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR 10575, Feb. 16, 2001]
Additives that reference this regulation: |
