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e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter BPart 172Subpart I → §172.809

Title 21: Food and Drugs
Subpart I—Multipurpose Additives

§172.809   Curdlan.

Curdlan may be safely used in accordance with the following conditions:

(a) Curdlan is a high molecular weight polymer of glucose (β-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 Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-402-1200, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5001 Campus Dr., 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 600 × 103 dyne per square centimeter.

(10) Aerobic plate count, not more than 103 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 standards of identity established under section 401 of the act do not preclude such use.

[61 FR 65941, Dec. 16, 1996, as amended at 78 FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016]

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