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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>3</VOL>
    <DATE>2000-04-01</DATE>
    <ORIGINALDATE>2000-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Laminate structures for use at temperatures between 120 Â°F and 250 Â°F.</TITLE>
    <GRANULENUM>177.1395</GRANULENUM>
    <HEADING>Section 177.1395</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 21" SEQ="2">Food and Drugs</PARENT>
      <PARENT HEADING="PART 177" SEQ="1">INDIRECT FOOD ADDITIVES: POLYMERS</PARENT>
      <PARENT HEADING="Subpart B" SEQ="0">Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 177.1395</SECTNO>
    <SUBJECT>Laminate structures for use at temperatures between 120 °F and 250 °F.</SUBJECT>

    <P>(a) The laminates identified in this section may be safely used at the specified temperatures. These articles are layered structures that are optionally <PRTPAGE P="258"/>bonded with adhesives. In these articles, the food-contact layer does not function as a barrier to migration of components from non-food-contact layers. The layers may be laminated, extruded, coextruded, or fused.</P>
    <P>(b) Laminate structures may be manufactured from:</P>
    <P>(1) Polymers and adjuvants complying with § 177.1390 of this chapter.</P>
    <P>(2) Any polymeric resin listed in these regulations so long as the use of the resin in the structure complies with the conditions of use (food type and time/temperature) specified in the regulation for that resin.</P>
    <P>(3) Optional adjuvant substances used in accordance with § 174.5 of this chapter.</P>
    <P>(4) The following substances in non-food-contact layers only:</P>
    <GPOTABLE CDEF="s10,r10" COLS="2" OPTS="L2">
      <BOXHD>
        <CHED H="1">Substances</CHED>
        <CHED H="1">Limitations</CHED>
      </BOXHD>
      <ROW>
        <ENT I="01">Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) complying with § 177.1345</ENT>

        <ENT>For use only with polyethylene terephthalate as the food-contact layer, complying with § 177.1630 under conditions of use C through G described in table 2 of § 176.170(c) of this chapter. Laminate structures, when extracted with 8 percent ethanol at 150 °F for 2 hours shall not yield <E T="03">m</E>-pheny lenedioxy-O,O′-diethyl isophthalate or cyclic bis(ethylene isophthalate) in excess of 7.8 micrograms/square decimeter (0.5 microgram/square inch) of food-contact surface.</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Nylon 6/12 resins complying with § 177.1500(b), item 13.2, of this chapter (CAS Reg. No. 25191-04-2)</ENT>

        <ENT>For use with nonalcoholic foods at temperatures not to exceed 100 °C (212 °F). Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of <E T="03">epsilon</E>-caprolactam and 0.04 milligram of <E T="03">omega</E>-laurolactam per square inch when extracted with water at 100 °C (212 °F) for 5 hours.</ENT>
      </ROW>
      <ROW>
        <ENT I="01">Nylon 6/66 resins complying with § 177.1500(b), item 4.2 of this chapter (CAS Reg. 24993-04-2)</ENT>

        <ENT>For use only with:<LI>1. Nonalcoholic foods at temperatures not to exceed 82.2 <E T="71">½</E>C (180 <E T="71">½</E>F).  Laminate structures with authorized food-contact materials yield no more than 0.15 milligram of <E T="03">epsilon</E>-caprolactam per square inch when extracted with water at 82.2 <E T="71">½</E>C (180 <E T="71">½</E>F) for 5 hours.</LI>
          <LI>2. Nonalcoholic foods at temperatures not to exceed 100 <E T="71">½</E>C (212 <E T="71">½</E>F).  Laminate films with authorized food-contact materials yield no more than 0.15 milligram of <E T="03">epsilon</E>-caprolactam per square inch when extracted with water at 100 <E T="71">½</E>C (212 <E T="71">½</E>F) for 5 hours.</LI>
        </ENT>
      </ROW>
      <ROW>
        <ENT I="01">Nylon 6/69 resins complying with § 177.1500(b), item 14, of this chapter (CAS Reg. No. 51995-62-1)</ENT>
        <ENT>For use with nonalcoholic foods under conditions of use B, C, D, E, F, G, and H described in table 2 of § 176.170 of this chapter. Laminate structures with authorized food-contact materials may contain nylon 6/69 resins provided that the nitrogen content of aqueous extracts of a representative laminate (obtained at 100 °C (212 °F) for 8 hours) does not exceed 15 micrograms per square centimeter (100 micrograms per square inch).</ENT>
      </ROW>
    </GPOTABLE>
    <CITA>[52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, Oct. 17, 1997]</CITA>
  </SECTION>
</CFRGRANULE>
