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184.1676 Pyridoxine hydrochloride.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1676 Pyridoxine hydrochloride.



[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: 21CFR184.1676]

[Page 557-558]
 
                        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.  184.1676  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: 
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 a nutrient supplement as defined in 
Sec.  170.3(o)(20) of this chapter.

[[Page 558]]

    (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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1676


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