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184.1535 Niacinamide.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1535 Niacinamide.



[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: 21CFR184.1535]

[Page 546]
 
                        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.  184.1535  Niacinamide.

    (a) Niacinamide (C6H6N2O, CAS Reg. 
No. 98-92-0) is the chemical 3-pyridinecarboxylic acid amide 
(nicotinamide). It is a white crystalline powder that is soluble in 
water, alcohol, ether, and glycerol. It melts between 128[deg] and 131 
[deg]C.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 205, 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.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice. The ingredient may also 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 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1535


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