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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: 21CFR184.1370]



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. 184.1370 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 § 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 § 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.

(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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