subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"
part_code: "173"
part_subject: "SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION"
subpart_code: "A"
subpart_subject: "Polymer Substances and Polymer Adjuvants for Food Treatment"
section_number: "173.45"
section_subject: "Polymaleic acid and its sodium salt."
cfr_reference: "21 CFR 173.45"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 170 to 199"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS Reg. No. 70247-90-4) may be safely used in food in accordance with the following prescribed conditions:
(a)The additives have a weight-average molecular weight in the range of 540 to 850 and a number-average molecular weight in the range of 520 to 650, calculated as the acid. Molecular weights shall be determined by a method entitled “Determination of Molecular Weight Distribution of Poly(Maleic) Acid,” March 17, 1992, produced by Ciba-Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or are available for inspection at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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.
(b)The additives may be used, individually or together, in the processing of beet sugar juice and liquor or of cane sugar juice and liquor to control mineral scale.
(c)The additives are to be used so that the amount of either or both additives does not exceed 4 parts per million (calculated as the acid) by weight of the beet or cane sugar juice or liquor process stream.