[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR179.45] [Page 436-438] 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 Secs. 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 this chapter. The finished film may contain: (i) Adjuvant substances used in compliance with Secs. 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 Secs. 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 [[Page 437]] 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, 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. The finished film may contain adjuvant substances used in compliance with Secs. 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 this of the polymer. 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. ------------------------------------------------------------------------ (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 [[Page 438]] 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]