[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1311]
[Page 521]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 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 CFR part 51. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Center for Food
Safety and Applied Nutrition's library, 5100 Paint Branch Pkwy., College
Park, MD 20740, 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 Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 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]
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