[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
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.
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(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]
Additives that reference this regulation: