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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR184.1537]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 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 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, as amended at 73 FR 8607, Feb. 14, 2008]

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