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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 2019.

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, 2019]
[CITE: 21CFR173.400]



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 173 -- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

Subpart D--Specific Usage Additives

Sec. 173.400 Dimethyldialkylammonium chloride.

Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is produced by one of the following methods:

(1) Ammonolysis of natural tallow fatty acids to form amines that are subsequently reacted with methyl chloride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chloride and dimethyldihexadecylammonium chloride. The additive may contain residues of isopropyl alcohol not in excess of 18 percent by weight when used as a processing solvent.

(2) Ammonolysis of natural tallow fatty acids to form amines that are then reacted with 2-ethylhexanal, reduced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride.

(b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of free amine and amine hydrochloride. The food additive described in paragraph (a)(2) of this section contains not more than 3 percent by weight, each, of free amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, "Acid Value and Free Amine Value of Fatty Quaternary Ammonium Chlorides," 2d printing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(c) The food additive is used as a decolorizing agent in the clarification of refinery sugar liquors under the following limitations:

(1) The food additive described in paragraph (a)(1) of this section is added only at the defecation/clarification stage of sugar liquor refining in an amount not to exceed 700 parts per million by weight of sugar solids.

(2) The food additive described in paragraph (a)(2) of this section is used under the following conditions:

(i) The additive is adsorbed onto a support column composed of suitable polymers that are regulated for contact with aqueous food. Excess nonadsorbed additive shall be rinsed away with potable water prior to passage of sugar liquor through the column.

(ii) The residue of the additive in the decolorized sugar liquor prior to crystallization shall not exceed 1 part per million of sugar as determined by a method entitled "Colorimetric Determination of Residual Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar Solutions," June 13, 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]

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