[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.400]
[Page 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
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 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]
[[Page 153]]
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