[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: 21CFR172.809]
[Page 80-81]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart I_Multipurpose Additives
Sec. 172.809 Curdlan.
Curdlan may be safely used in accordance with the following
conditions:
(a) Curdlan is a high molecular weight polymer of glucose ([beta]-
1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture
fermentation from the nonpathogenic and nontoxicogenic bacterium
Alcaligenes faecalis var. myxogenes.
(b) Curdlan meets the following specifications when it is tested
according to the methods described or referenced in the document
entitled ``Analytical Methods for Specification Tests for Curdlan,'' by
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku,
Tokyo, 103, Japan, 1996, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Division of Petition Control (HFS-215), Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 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--federal--
regulations/ibr--locations.html.
(1) Positive for curdlan.
(2) Assay for curdlan (calculated as anhydrous glucose), not less
than 80 percent.
(3) pH of 1 percent aqueous suspension, 6.0-7.5.
(4) Lead, not more than 0.5 mg/kg.
(5) Heavy metals (as Pb), not more than 0.002 percent.
(6) Total nitrogen, not more than 0.2 percent.
(7) Loss on drying, not more than 10 percent.
(8) Residue on ignition, not more than 6 percent.
(9) Gel strength of 2 percent aqueous suspension, not less than
600x10\3\ dyne per square centimeter.
(10) Aerobic plate count, not more than 10\3\ per gram.
(11) Coliform bacteria, not more than 3 per gram.
(c) Curdlan is used or intended for use in accordance with good
manufacturing practice as a formulation aid, processing aid, stabilizer
and thickener, and texturizer in foods for which
[[Page 81]]
standards of identity established under section 401 of the act do not
preclude such use.
[61 FR 65941, Dec. 16, 1996]
Additives that reference this regulation: |
