[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1007]

[Page 466-467]
 
                        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. 184.1007  Aconitic acid.

    (a) Aconitic acid (1,2,3-propenetricarboxylic acid 
(C6H6O6), CAS Reg. No. 000499-12-7) 
occurs in the leaves and tubers of Aconitum napellus L. and other 
Ranunculaceae.

[[Page 467]]

Transaconitic acid can be isolated during sugarcane processing, by 
precipitation as the calcium salt from cane sugar or molasses. It may be 
synthesized by sulfuric acid dehydration of citric acid, but not by the 
methanesulfonic acid method.
    (b) The ingredient meets the following specifications:
    (1) Assay. Not less than 98.0 percent of 
C3H3(COOH)3, using the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 102-103, test for citric acid, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, and a molecular weight of 174.11. Copies of the material 
incorporated by reference are available from the National Academy Press, 
Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet 
address ``http://www.nap.edu''), or may be examined at the Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (2) Melting point. Not less than 195  deg.C and the determination 
results in decomposition of aconitic acid.
    (3) Heavy metals (as Pb). Not more than 10 parts per million.
    (4) Arsenic (as As). Not more than 3 parts per million.
    (5) Oxalate. Passes test.
    (6) Readily carbonizable substances. Passes the test for citric acid 
of the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given in 
paragraph (b)(1) of this section.
    (7) Residue on ignition. Not more than 0.1 percent as determined by 
the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103, test for 
citric acid, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in paragraph (b)(1) of this section.
    (c) The ingredient is used as a flavoring substance and adjuvant as 
defined in Sec. 170.3(o)(12) of this chapter.
    (d) The ingredient is used in food, in accordance with 
Sec. 184.1(b)(1), at levels not to exceed good manufacturing practice. 
Current good manufacturing practice results in a maximum level, as 
served, of 0.003 percent for baked goods as defined in Sec. 170.3(n)(1) 
of this chapter, 0.002 percent for alcoholic beverages as defined in 
Sec. 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy 
products as defined in Sec. 170.3(n)(20) of this chapter, 0.0035 percent 
for soft candy as defined in Sec. 170.3(n)(38) of this chapter, and 
0.0005 percent or less for all other food categories.
    (e) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[43 FR 47724, Oct. 17, 1978, as amended at 49 FR 5610, Feb. 14, 1984; 64 
FR 1759, Jan. 12, 1999]