Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 184  /  Sec. 184.1307 Ferric sulfate.

(a) Ferric sulfate (iron (III) sulfate, Fe2(SO4)3 CAS Reg. No. 10028-22-5) is a yellow substance that may be prepared by oxidizing iron (II) sulfate or by treating ferric oxide or ferric hydroxide with sulfuric acid.

(b) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food as a flavoring agent as defined in Sec. 170.3(o)(12) of this chapter, with no limitation other than current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. [53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008] Sec. 184.1307a Ferrous ascorbate.

(a) Ferrous ascorbate (CAS Reg. No. 24808-52-4) is a reaction product of ferrous hydroxide and ascorbic acid. It is a blue-violet product containing 16 percent iron.

(b) The ingredient must be of a purity suitable for its intended use.

(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, with no 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 16865, May 12, 1988, as amended at 69 FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, 2008] Sec. 184.1307b Ferrous carbonate.

(a) Ferrous carbonate (iron (II) carbonate, FeCO3, CAS Reg. No. 563-71-3) is an odorless, white solid prepared by treating solutions of iron (II) salts with alkali carbonate salts.

(b) The ingredient must be of a purity suitable for its intended use.

(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, with no 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 Foods, 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 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008] Sec. 184.1307c Ferrous citrate.

(a) Ferrous citrate (iron (II) citrate, (C6H6FeO7), CAS Reg. No. 23383-11-1) is a slightly colored powder or white crystals. It is prepared from the reaction of sodium citrate with ferrous sulfate or by direct action of citric acid on iron filings.

(b) The ingredient must be of a purity suitable for its intended use.

(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, with no 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 73 FR 8607, Feb. 14, 2008] Sec. 184.1307d Ferrous fumarate.

(a) Ferrous fumarate (iron (II) fumarate, (C4H2FeO4), CAS Reg. No. 141-01-5) is an odorless, reddish-orange to reddish-brown powder. It may contain soft lumps that produce a yellow streak when crushed. It is prepared by admixing hot solutions of ferrous sulfate and sodium fumarate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 120-122, 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 ingredient is used in food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this chapter, with no 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]