[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: 21CFR184.1069]

[Page 479]
 
                        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. 184.1069  Malic acid.

    (a) Malic acid (C4H6O5, CAS Reg. 
No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common 
name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid, 
referred to as L-malic acid, occurs naturally in various foods. Racemic 
DL-malic acid does not occur naturally. It is made commercially by 
hydration of fumaric acid or maleic acid.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 183-184, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) The ingredients are used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter, flavoring agent and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter, and pH control agent as 
defined in Sec. 170.3(o)(23) of this chapter.
    (d) The ingredients are used in food, except baby food, at levels 
not to exceed good manufacturing practice in accordance with Sec. 
184.1(b)(1). Current good manufacturing practice results in a maximum 
level, as served, of 3.4 percent for nonalcoholic beverages as defined 
in Sec. 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as 
defined in Sec. 170.3(n)(6) of this chapter; 0.8 percent for gelatins, 
puddings, and fillings as defined in Sec. 170.3(n)(22) of this chapter; 
6.9 percent for hard candy as defined in Sec. 170.3(n)(25) of this 
chapter; 2.6 percent for jams and jellies as defined in Sec. 
170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit 
juices as defined in Sec. 170.3(n)(35) of this chapter; 3.0 percent for 
soft candy as defined in Sec. 170.3(n)(38) of this chapter; and 0.7 
percent for all other food categories.
    (e) Prior sanctions for malic acid different from the uses 
established in this section do not exist or have been waived.

[44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]