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184.1449 Manganese citrate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1449 Manganese citrate.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1449]

[Page 540]
 
                        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 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1449  Manganese citrate.

    (a) Manganese citrate 
(Mn3(C6H5O7)2, 
CAS Reg. No. 1002-46-65) 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) FDA is developing food-grade specifications for manganese 
citrate in cooperation with the National Academy of Sciences. In the 
interim, this ingredient must be of purity suitable for its intended 
use.
    (c) In accordance with Sec.  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 
Sec.  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 
Sec.  170.3(n)(1) of this chapter; nonalcoholic beverages as defined in 
Sec.  170.3(n)(3) of this chapter; dairy product analogs as defined in 
Sec.  170.3(n)(10) of this chapter; fish products as defined in Sec.  
170.3(n)(13) of this chapter; meat products as defined in Sec.  
170.3(n)(29) of this chapter; milk products as defined in Sec.  
170.3(n)(31) of this chapter; and poultry products as defined in Sec.  
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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1449


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