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173.400 Dimethyldialkylammonium chloride.

Home > Regulations > Secondary direct food additives permitted in food for human consumption > 173.400 Dimethyldialkylammonium chloride.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.400]

[Page 151-152]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 173_SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN 
CONSUMPTION--Table of Contents
 
                   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 di methyl dihexa decyl ammonium 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-ethyl hexyl) 
octa decyl ammonium chloride and dimethyl (2-ethyl hexyl) hexa decyl 
ammonium 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, 5100 Paint 
Branch Pkwy., 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/
federal--register/code--of--federal--regulations/ibr--locations.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

[[Page 152]]

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, 
5100 Paint Branch Pkwy., 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/federal--register/code--of--
federal--regulations/ibr--locations.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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 173, Section 400


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