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e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter BPart 172Subpart D → §172.350


Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart D—Special Dietary and Nutritional Additives


§172.350   Fumaric acid and salts of fumaric acid.

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.

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