[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. 184.1372 Insoluble glucose isomerase enzyme preparations.
(a) Insoluble glucose isomerase enzyme preparations are used in the
production of high fructose corn syrup described in Sec. 184.1866. They
are derived from recognized species of precisely classified
nonpathogenic and nontoxicogenic microorganisms, including Streptomyces
rubiginosus, Actinoplanes missouriensis, Streptomyces olivaceus,
Streptomyces olivochromogenes, and Bacillus coagulans, that have been
grown in a pure culture fermentation that produces no antibiotics. They
are fixed (rendered insoluble) for batch production with GRAS
ingredients or may be fixed for further immobilization with either GRAS
ingredients or materials approved under Sec. 173.357 of this chapter.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107,
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/
(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 an enzyme, as defined in Sec.
170.3(o)(9) of this chapter, to convert glucose to fructose.
(2) The ingredient is used in high fructose corn syrup, at levels
not to exceed current good manufacturing practice.
[48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996]
Additives that reference this regulation: