[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. 184.1875 Thiamine hydrochloride.
(a) Thiamine hydrochloride
(C12H17C1N4OS[middot]HCl, CAS Reg. No.
67-03-8) is the chloride-hydrochloride salt of thiamine. It occurs as
hygroscopic white crystals or a white crystalline powder. The usual
method of preparing this substance is by linking the preformed thiazole
and pyrimidine ring systems.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 324, 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 flavoring agent and adjuvant as
defined in Sec. 170.3(o)(12) of this chapter or as a nutrient
supplement as defined in Sec. 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine 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 55124, Dec. 9, 1983]
Additives that reference this regulation: