subchapter_subject: "FOOD FOR HUMAN CONSUMPTION (CONTINUED)"
part_code: "172"
part_subject: "FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION"
subpart_code: "D"
subpart_subject: "Special Dietary and Nutritional Additives"
section_number: "172.350"
section_subject: "Fumaric acid and salts of fumaric acid."
cfr_reference: "21 CFR 172.350"
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"
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Fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food in accordance with the following prescribed conditions:
(a)The additives meet the following specifications:
(1)Fumaric acid contains a minimum of 99.5 percent by weight of fumaric acid, calculated on the anhydrous basis.
(2)The calcium, magnesium, potassium, and sodium salts contain a minimum of 99 percent by weight of the respective salt, calculated on the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent total iron and not more than 2 percent ferric iron.
(b)With the exception of ferrous fumarate, fumaric acid and the named salts are used singly or in combination in food at a level not in excess of the amount reasonably required to accomplish the intended effect.
(c)Ferrous fumarate is used as a source of iron in foods for special dietary use, when the use is consistent with good nutrition practice.