[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: 21CFR184.1261]
[Page 513]
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
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]
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