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184.1261 Copper sulfate.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1261 Copper sulfate.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1261]

[Page 512]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1261  Copper sulfate.

    (a) Copper sulfate (cupric sulfate, 
CuSO4[middot]5H2O, CAS Reg. No. 7758-98-7) usually 
is used in the pentahydrate form. This form occurs as large, deep blue 
or ultramarine, triclinic crystals; as blue granules, or as a light blue 
powder. The ingredient is prepared by the reaction of sulfuric acid with 
cupric oxide or with copper metal.
    (b) FDA is developing food-grade specifications for copper sulfate 
in cooperation with the National Academy of Sciences. In the interim, 
this ingredient must be of a purity suitable for its intended use.
    (c) In accordance with Sec.  184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a nutrient supplement as defined in 
Sec.  170.3(o)(20) of this chapter and as a processing aid as defined in 
Sec.  170.3(o)(24) of this chapter.
    (2) The ingredient is used in food at levels not to exceed current 
good manufacturing practice. Copper sulfate may be used in infant 
formula in accordance with section 412(g) of the Federal Food, Drug, and 
Cosmetic Act (the Act) or with regulations promulgated under section 
412(a)(2) of the Act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

[49 FR 24119, June 12, 1984]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1261


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