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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: 21CFR184.1009]



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. 184.1009 Adipic acid.

(a) Adipic acid (C6H10O4, CAS Reg. No. 00124-04-9) is also known as 1,4-butanedicarboxylic acid or hexane-dioic acid. It is prepared by nitric acid oxidation of cyclohexanol or cyclohexanone or a mixture of the two.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 11, which is incorporated by reference (Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or available for inspection 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. ), and the following additional specifications:

(1) The adipic acid is converted to its corresponding amide. The amide is purified by recrystallization from water or aqueous ethanol. The melting range of the amide is 219deg. to 220 deg. C.

(2) The adipic acid is converted to its corresponding bis-p-p- bromophenacyl ester. The ester is purified by recrystallization from ethanol. The melting range of the ester is 153deg. to 154 deg. C.

(c) The ingredient is used as a flavoring agent as defined in 170.3(o)(12) of this chapter; leavening agent as defined in 170.3(o)(17) of this chapter; and pH control agent as defined in 170.3(o)(23) of this chapter.

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 0.05 percent for baked goods as defined in 170.3(n)(1) of this chapter; 0.005 percent for nonalcoholic beverages as defined in 170.3(n)(3) of this chapter; 5.0 percent for condiments and relishes as defined in 170.3(n)(8) of this chapter; 0.45 percent for dairy product analogs as defined in 170.3(n)(10) of this chapter; 0.3 percent for fats and oil as defined in 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined in 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings as defined in 170.3(n)(22) of this chapter; 0.1 percent for gravies as defined in 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in 170.3(n)(29) of this chapter; 1.3 percent for snack foods as defined in 170.3(n)(37) of this chapter; and 0.02 percent or less for all other food categories.

(e) Prior sanctions for adipic acid different from the uses established in this section do not exist or have been waived.

[47 FR 27810, June 25, 1982]

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