[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]
Additives that reference this regulation: |
