21 C.F.R. § 184.1537   Nickel.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS

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§ 184.1537   Nickel.

(a) Elemental nickel (CAS Reg. No. 7440–02–0) is obtained from nickel ore by transforming it to nickel sulfide (Ni3S2). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is then reduced with carbon to give elemental nickel.

(b) The Food and Drug Administration is developing food-grade specifications for nickel 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 §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 catalyst as defined in §170.3(o)(24) of this chapter.

(2) The ingredient is used in the hydrogenation of fats and oils as defined in §170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. Current good manufacturing practice includes the removal of nickel from fats and oils following hydrogenation.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[48 FR 51618, Nov. 10, 1983]

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