[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: 21CFR184.1318]
[Page 521-522]
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. 184.1318 Glucono delta-lactone.
(a) Glucono delta-lactone (C6H10O6,
CAS Reg. No. 90-80-2), also called D-gluconic acid delta-lactone or D-
glucono-1,5-lactone, is the cyclic 1,5-intramolecular ester of D-
gluconic acid. It is prepared by direct crystallization from the aqueous
solution of gluconic acid. Gluconic acid may be produced by the
oxidation of D-glucose with bromine water, by the oxidation of D-glucose
by microorganisms that are nonpathogenic and nontoxicogenic to man or
other animals, or by the oxidation of D-glucose with enzymes derived
from these microorganisms.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 134, 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
[[Page 522]]
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 curing and pickling agent as defined
in Sec. 170.3(o)(5) of this chapter, leavening agent as defined in
Sec. 170.3(o)(17) of this chapter; pH control agent as defined in Sec.
170.3(o)(23) of this chapter; and sequestrant as defined in Sec.
170.3(o)(26) of this chapter.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[51 FR 33896, Sept. 24, 1986]
Additives that reference this regulation: |
