[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: 21CFR184.1315]
[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. 184.1315 Ferrous sulfate.
(a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate,
FeSO4[middot]7H2O, CAS Reg. No. 7782-63-0) is
prepared by the action of sulfuric acid on iron. It occurs as pale,
bluish-green crystals or granules. Progressive heating of ferrous
sulfate heptahydrate produces ferrous sulfate (dried). Ferrous sulfate
(dried) consists primarily of ferrous sulfate monohydrate (CAS Reg. No.
17375-41-6) with varying amounts of ferrous sulfate tetrahydrate (CAS
Reg. No. 20908-72-9) and occurs as a grayish-white to buff-colored
powder.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124
(ferrous sulfate, dried), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave., NW.,
Washington, DC 20418, or available for inspection 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 ingredients are used
in food as nutrient supplements as defined in Sec. 170.3(o)(20) of this
chapter and as a processing aid as defined in Sec. 170.3(o)(24) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredients 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 these ingredients different from the uses
established in this section do not exist or have been waived.
[53 FR 16866, May 12, 1988]
[[Page 522]]
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