21 CFR 179.45 - Packaging materials for use during the irradiation of prepackaged foods.

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§ 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 § 177.1200 of this chapter.
(2) Glassine paper complying with § 176.170 of this chapter.
(3) Wax-coated paperboard complying with § 176.170 of this chapter.
(4) Polyolefin film prepared from one or more of the basic olefin polymers complying with § 177.1520 of this chapter. The finished film may contain:
(i) Adjuvant substances used in compliance with §§ 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 § 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 § 177.1630(e)(4)(i) and (ii) of this chapter. The finished film may contain:
(i) Adjuvant substances used in compliance with §§ 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 § 177.1520 of this chapter.
(7) Polystyrene film prepared from styrene basic polymer. The finished film may contain adjuvant substances used in compliance with §§ 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 §§ 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 §§ 178.3740 and 181.22 through 181.30 of this chapter.
(10) Nylon 11 conforming to § 177.1500 of this chapter.
(c) Ethylene-vinyl acetate copolymers complying with § 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 § 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, palmitic, and stearic acid Not to exceed 1 pct by weight of the polymer.
BHA as described in § 172.110 of this chapter Do.
BHT as described in § 172.115 of this chapter Do.
Calcium and sodium propionates Do.
Petroleum wax as described in § 178.3710 of this chapter Do.
Polypropylene, noncrystalline, as described in § 177.1520(c) of this chapter Not to exceed 2 pct by weight of the polymer.
Stearates of aluminum, calcium, magnesium, potassium, and sodium as described in § 172.863(a) of this chapter Not to exceed 1 pct by weight of the polymer.
Triethylene glycol as described in § 178.3740(b) of this chapter Do.
Mineral oil as described in § 178.3620 (a) or (b) of this chapter Do.
(ii) Polyethylene terephthalate film prepared from the basic polymer as described in § 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 § 177.1500(a)(6) of this chapter and meeting the specifications of item 6.1 of the table in § 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 °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 § 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-04-14; vol. 79 # 71 - Monday, April 14, 2014
    1. 79 FR 20771 - Irradiation in the Production, Processing and Handling of Food
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 14, 2014. See section VII of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 14, 2014.
      21 CFR Part 179

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 179 after this date.

  • 2014-04-14; vol. 79 # 71 - Monday, April 14, 2014
    1. 79 FR 20771 - Irradiation in the Production, Processing and Handling of Food
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 14, 2014. See section VII of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 14, 2014.
      21 CFR Part 179