[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1676 Pyridoxine hydrochloride.
(a) Pyridoxine hydrochloride
(C8H11NO3[middot]HCl, CAS Reg. No. 58-
56-0) is the chemical 3-hydroxy-4,5-dihydroxymethy-2-methylpyridine
hydrochloride that is prepared by chemical synthesis.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 260, 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:
(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 a nutrient supplement as defined in
Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
Sec. 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage
bases as defined in Sec. 170.3(n)(3) of this chapter; breakfast cereals
as defined in Sec. 170.3(n)(4) of this chapter; dairy product analogs
as defined in Sec. 170.3(n)(10) of this chapter; meat products as
defined in Sec. 170.3(n)(29) of this chapter; milk products as defined
in Sec. 170.3(n)(31) of this chapter; plant protein products as defined
in Sec. 170.3(n)(33) of this chapter; and snack foods as defined in
Sec. 170.3(n)(37) of this chapter. Pyridoxine hydrochloride 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.
[48 FR 51615, Nov. 10, 1983]
Additives that reference this regulation: