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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 2017.

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, 2017]
[CITE: 21CFR184.1007]



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. 184.1007 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. 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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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.

(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 170.3(o)(12) of this chapter.

(d) The ingredient is used in food, in accordance with 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 170.3(n)(1) of this chapter, 0.002 percent for alcoholic beverages as defined in 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy products as defined in 170.3(n)(20) of this chapter, 0.0035 percent for soft candy as defined in 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; 81 FR 5595, Feb. 3, 2016]

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