[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. 184.1530 Niacin.
(a) Niacin (C6H5NO2, CAS Reg. No.
59-67-6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It
is a non-hygroscopic, stable, white, crystalline solid that sublimes
without decomposition at about 230 [deg]C. It is soluble in water and
alcohol. It is insoluble in ether.
(b) The ingredient meets the specifications of the ``Food Chemicals
Codex,'' 4th ed. (1996), p. 264, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the National Academy Press, Box 285, 2101 Constitution Ave. NW.,
Washington, DC 20055 (Internet address http://www.nap.edu), or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or 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--
(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 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, as amended at 64
FR 1760, Jan. 12, 1999]
Additives that reference this regulation: