21 CFR 184.1311 - Ferrous lactate.

§ 184.1311 Ferrous lactate.

(a) Ferrous lactate (iron (II) lactate, C6H10FeO6, CAS Reg. No. 5905-52-2) in the trihydrate form is a greenish-white powder or crystalline mass. It is prepared by reacting calcium lactate or sodium lactate with ferrous sulfate, direct reaction of lactic acid with iron filings, reaction of ferrous chloride with sodium lactate, or reaction of ferrous sulfate with ammonium lactate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food as a nutrient supplement as defined in § 170.3(o)(20) of this chapter and as a color fixative for ripe olives, with no other limitation other than current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act ( 21 U.S.C. 350a(a)(2)).

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[ 53 FR 16866, May 12, 1988, as amended at 61 FR 40319, Aug. 2, 1996; 81 FR 5595, Feb. 3, 2016]

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United States Code

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 184 after this date.

  • 2016-09-08; vol. 81 # 174 - Thursday, September 8, 2016
    1. 81 FR - Substances Generally Recognized as Safe
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      21 CFR Parts 20, 25, 170, 184, 186, and 570
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