TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 172 - FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

subpart i - MULTIPURPOSE ADDITIVES

172.841 - Polydextrose.

Polydextrose as identified in this section may be safely used in food in accordance with the following prescribed conditions: (a)(1) Polydextrose (CAS Reg. No. 68424044) 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, 4th ed. (1996), pp. 297300, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

  (c) Polydextrose is used in accordance with current good manufacturing practices as a bulking agent, formulation aid, humectant, and texturizer in the following foods when standards of identity established under section 401 of the act do not preclude such use: (1) Baked goods and baking mixes (restricted to fruit, custard, and pudding-filled pies, cakes, cookies, and similar baked products); (2) Chewing gum; (3) Confections and frostings; (4) Dressings for salads; (5) Film coatings on single and multiple vitamin and mineral supplement tablets; (6) Frozen dairy desserts and mixes; (7) Fruit and water ices; (8) Fruit spreads; (9) Gelatins, puddings and fillings; (10) Hard and soft candy; (11) Peanut spread; (12) Sweet sauces, toppings, and syrups; (13) Tablespreads.

  (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]