[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: 21CFR184.1431]
[Page 536]
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. 184.1431 Magnesium oxide.
(a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally
as the colorless, crystalline mineral periclase. It is produced either
as a bulky white powder (light) or a relatively dense white powder
(heavy) by heating magnesium hydroxide or carbonate. Heating these
magnesium salts under moderate conditions (400[deg] to 900 [deg]C for a
few hours) produces light magnesium oxide. Heating the salts under more
rigorous conditions (1200 [deg]C for 12 hours) produces heavy magnesium
oxide. Light magnesium oxide is converted to heavy magnesium oxide by
sustained heating at high temperatures.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(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 an anticaking and free-flow agent as
defined in Sec. 170.3(o)(1) of this chapter; a firming agent as defined
in Sec. 170.3(o)(10) of this chapter; a lubricant and release agent as
defined in Sec. 170.3(o)(18) of this chapter; a nutrient supplement as
defined in Sec. 170.3(o)(20) of this chapter; and a pH control agent as
defined in Sec. 170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not be exceed current
good manufacturing practice. The ingredient also 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.
[50 FR 13559, Apr. 5, 1985]
[[Page 537]]
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