• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

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).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR173.60]



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 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 conditions:

(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, 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.

(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]

-
-