[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1061]

[Page 477]
 
                        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. 184.1061  Lactic acid.

    (a) Lactic acid (C3H6O3, CAS Reg. 
Nos.: dl mixture, 598-82-3; l-isomer, 79-33-4; d-isomer, 10326-41-7), 
the chemical 2-hydroxypropanoic acid, occurs naturally in several foods. 
It is produced commercially either by fermentation of carbohydrates such 
as glucose, sucrose, or lactose, or by a procedure involving formation 
of lactonitrile from acetaldehyde and hydrogen cyanide and subsequent 
hydrolysis to lactic acid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Avenue, 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (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 an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter; a curing and pickling agent as 
defined in Sec. 170.3(o)(5) of this chapter; a flavor enhancer as 
defined in Sec. 170.3(o)(11) of this chapter; a flavoring agent and 
adjuvant as defined in Sec. 170.3(o)(12) of this chapter; a pH control 
agent as defined in Sec. 170.3(o)(23) of this chapter; and a solvent 
and vehicle as defined in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in food, except in infant foods and 
infant formulas, 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.

[49 FR 35367, Sept. 7, 1984]