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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>3</VOL>
    <DATE>2013-04-01</DATE>
    <ORIGINALDATE>2013-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Sodium lactate.</TITLE>
    <GRANULENUM>184.1768</GRANULENUM>
    <HEADING>Section 184.1768</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>§ 184.1768</SECTNO>
    <SUBJECT>Sodium lactate.</SUBJECT>
    <P>(a) Sodium lactate (C<E T="52">3</E>H<E T="52">5</E>O<E T="52">3</E>N<E T="52">a</E>, CAS Reg. No. 72-17-3) is the sodium salt of lactic acid. It is prepared commercially by the neutralization of lactic acid with sodium hydroxide.</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 limitation other than current good manufacturing practice. This regulation does not authorize its use in infant foods and infant formulas. 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 an emulsifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; and a pH control agent as defined in § 170.3(o)(23) 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>[52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008]</CITA>
  </SECTION>
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