21 CFR § 184.1449 - Manganese citrate.

§ 184.1449 Manganese citrate.

(a) Manganese citrate (Mn3(C6H5O7)2, CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. It is obtained by precipitating manganese carbonate from manganese sulfate and sodium carbonate solutions. The filtered and washed precipitate is digested first with sufficient citric acid solution to form manganous citrate and then with sodium citrate to complete the reaction.

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

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. 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:

(1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(13) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk products as defined in § 170.3(n)(31) of this chapter; and poultry products as defined in § 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act.

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

[50 FR 19166, May 7, 1985, as amended at 73 FR 8607, Feb. 14, 2008; 76 FR 59250, Sept. 26, 2011]

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