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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>3</VOL>
    <DATE>2012-04-01</DATE>
    <ORIGINALDATE>2012-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Helium.</TITLE>
    <GRANULENUM>184.1355</GRANULENUM>
    <HEADING>Section 184.1355</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 21" SEQ="4">Food and Drugs</PARENT>
      <PARENT HEADING="CHAPTER I" SEQ="3">FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)</PARENT>
      <PARENT HEADING="SUBCHAPTER B" SEQ="2">FOOD FOR HUMAN CONSUMPTION (CONTINUED)</PARENT>
      <PARENT HEADING="PART 184" SEQ="1">DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE</PARENT>
      <PARENT HEADING="Subpart B" SEQ="0">Listing of Specific Substances Affirmed as GRAS</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 184.1355</SECTNO>
    <SUBJECT>Helium.</SUBJECT>
    <P>(a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a colorless, odorless, flavorless, nonflammable, inert gas. It is lighter than air and is produced by the liquefaction and purification of natural gas.</P>
    <P>(b) The ingredient must be of a purity suitable for its intended use.</P>

    <P>(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no <PRTPAGE P="534"/>limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:</P>
    <P>(1) The ingredient is used as a processing aid as defined in § 170.3(o)(24) of this chapter.</P>
    <P>(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.</P>
    <P>(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.</P>
    <CITA>[48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008]</CITA>
  </SECTION>
</CFRGRANULE>
