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184.1768 Sodium lactate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1768 Sodium lactate.



[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: 21CFR184.1768]

[Page 565]
 
                        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.  184.1768  Sodium lactate.

    (a) Sodium lactate 
(C3H5O3Na, CAS Reg. No. 72-
17-3) is the sodium salt of lactic acid. It is prepared commercially by 
the neutralization of lactic acid with sodium hydroxide.
    (b) FDA is developing food-grade specifications for sodium lactate 
in cooperation with the National Academy of Sciences. In the interim, 
this 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 with no limitation other than current good manufacturing practice. 
This regulation does not authorize its use in infant foods and infant 
formulas. 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 an emulsifier as defined in Sec.  
170.3(o)(8) of this chapter; a flavor enhancer as defined in Sec.  
170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined 
in Sec.  170.3(o)(12) of this chapter; a humectant as defined in Sec.  
170.3(o)(16) of this chapter; and a pH control agent as defined in Sec.  
170.3(o)(23) of this chapter.
    (2) The ingredient is used in food at levels not to exceed 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.

[52 FR 10886, Apr. 6, 1987]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1768


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