[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: 21CFR184.1370]
[Page 529-530]
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. 184.1370 Inositol.
(a) Inositol, or myo-inositol
(C6H12O6, CAS Reg. No. 87-89-8), is
cis-1,2,3,5-trans-4,6-cyclohexanehexol. It occurs naturally and is
prepared from an aqueous (0.2 percent sulfur dioxide) extract of corn
kernels by precipitation and hydrolysis of crude phytate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 150, 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 limitations 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.
(2) The ingredient is used in special dietary foods as defined in
part 105 of this chapter at levels not to exceed current good
manufacturing practice. It may also be used in infant formula in
accordance with section 412(g) of the Act, or with regulations
promulgated under section 412(a)(2) of the Act.
[[Page 530]]
(d) Prior sanctions for this ingredient different from the uses
established by this section do not exist or have been waived.
[47 FR 38278, Aug. 31, 1982]
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