[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.350]
[Page 49]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
Subpart D Special Dietary and Nutritional Additives
Sec. 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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