Section 172.841 - PolydextrosePolydextrose as identified in this section may be safely used in food in accordance with the following prescribed conditions:
(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially metabolizable water-soluble polymer prepared by the condensation of a melt which consists either of approximately 89 percent D-glucose, 10 percent sorbitol, and 1 percent citric acid or of approximately 90 percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid, on a weight basis.(2) Polydextrose may be partially neutralized with potassium hydroxide, or partially reduced by transition metal catalytic hydrogenation in aqueous solution.(b) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 811-814, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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/cfr/ibr-locations.html.(c) When standards of identity established under section 401 of the act do not preclude such use, polydextrose may be used in accordance with current good manufacturing practices as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry, baby food, and infant formula.(d) If the food containing the additive purports to be or is represented for special dietary uses, it shall be labeled in compliance with part 105 of this chapter.(e) The label and labeling of food a single serving of which would be expected to exceed 15 grams of the additive shall bear the statement: "Sensitive individuals may experience a laxative effect from excessive consumption of this product".46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR 64605 , Oct. 30, 2000; 65 FR 79719 , Dec. 20, 2000; 72 FR 46564 , Aug. 21, 2007; 78 FR 71464 , Nov. 29, 2013; 88 FR 17721 , Mar. 24, 2023