[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: 21CFR172.841]

[Page 93-94]
 
                        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.  172.841  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. 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,'' 4th ed. (1996), pp. 297-300, 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 202-741-6030, 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

[[Page 94]]

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]