[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: |
