[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.350]

[Page 45-46]
 
                        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 CONSUMPTION--Table of Contents
 
          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.

[[Page 46]]

    (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.