[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 173_SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart A_Polymer Substances and Polymer Adjuvants for Food Treatment
Sec. 173.60 Dimethylamine-epichlorohydrin copolymer.
Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0)
may be safely used in food in accordance with the following prescribed
(a) The food additive is produced by copolymerization of
dimethylamine and epichlorohydrin in which not more than 5 mole-percent
of dimethylamine may be replaced by an equimolar amount of
ethylenediamine, and in which the mole ratio of total amine to
epichlorohydrin is approximately 1:1.
(b) The additive meets the following specifications:
(1) The nitrogen content of the copolymer is 9.4 to 10.8 weight
percent on a dry basis.
(2) A 50-percent-by-weight aqueous solution of the copolymer has a
minimum viscosity of 175 centipoises at 25 [deg]C as determined by LVT-
series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by
another equivalent method).
(3) The additive contains not more than 1,000 parts per million of
1,3-dichloro-2-propanol and not more than 10 parts per million
epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content
is determined by an analytical method entitled ``The Determination of
Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-
Epichlorohydrin Copolymer,'' which is incorporated by reference. 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:
(4) Heavy metals (as Pb), 2 parts per million maximum.
(5) Arsenic (as As), 2 parts per million maximum.
(c) The food additive is used as a decolorizing agent and/or
flocculant in the clarification of refinery sugar liquors and juices. It
is added only at the defecation/clarification stage of sugar liquor
refining at a concentration not to exceed 150 parts per million of
copolymer by weight of sugar solids.
(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 Act, adequate directions to assure use in compliance with paragraph
(c) of this section.
[48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989]
Additives that reference this regulation: