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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR184.1449]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 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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