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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR184.1069]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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 National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredients are used as a flavor enhancer as defined in 170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in 170.3(o)(12) of this chapter, and pH control agent as defined in 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 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 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in 170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and fillings as defined in 170.3(n)(22) of this chapter; 6.9 percent for hard candy as defined in 170.3(n)(25) of this chapter; 2.6 percent for jams and jellies as defined in 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as defined in 170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in 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]

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