[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 180_FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN
INTERIM BASIS PENDING ADDITIONAL STUDY--Table of Contents
Subpart B_Specific Requirements for Certain Food Additives
Sec. 180.25 Mannitol.
(a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol
(C6H14O6) a hexahydric alcohol,
differing from sorbitol principally by having a different optical
rotation. Mannitol is produced by one of the following processes:
(1) The electrolytic reduction or transition metal catalytic
hydrogenation of sugar solutions containing glucose or fructose.
(2) The fermentation of sugars or sugar alcohols such as glucose,
sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii.
(3) A pure culture fermentation of sugars such as fructose, glucose,
or maltose using the nonpathogenic,
nontoxicogenic bacterium Lactobacillus intermedius (fermentum).
(b) The ingredient meets the specifications of the ``Food Chemicals
Codex,'' 3d Ed. (1981), pp. 188-190, which is incorporated by reference.
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(c) The ingredient is used as an anticaking agent and free-flow
agent as defined in Sec. 170.3(o)(1) of this chapter, formulation aid
as defined in Sec. 170.3(o) (14) of this chapter, firming agent as
defined in Sec. 170.3(o)(10) of this chapter, flavoring agent and
adjuvant as defined in Sec. 170.3(o)(12) of this chapter, lubricant and
release agent as defined in Sec. 170.3(o)(18) of this chapter,
nutritive sweetener as defined in Sec. 170.3(o)(21) of this chapter,
processing aid as defined in Sec. 170.3(o)(24) of this chapter,
stabilizer and thickener as defined in Sec. 170.3(o)(28) of this
chapter, surface-finishing agent as defined in Sec. 170.3(o)(30) of
this chapter, and texturizer as defined in Sec. 170.3(o)(32) of this
(d) The ingredient is used in food at levels not to exceed 98
percent in pressed mints and 5 percent in all other hard candy and cough
drops as defined in Sec. 170.3(n)(25) of this chapter, 31 percent in
chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 40 percent
in soft candy as defined in Sec. 170.3(n)(38) of this chapter, 8
percent in confections and frostings as defined in Sec. 170.3(n)(9) of
this chapter, 15 percent in nonstandardized jams and jellies,
commercial, as defined in Sec. 170.3(n)(28) of this chapter, and at
levels less than 2.5 percent in all other foods.
(e) The label and labeling of food whose reasonably foreseeable
consumption may result in a daily ingestion of 20 grams of mannitol
shall bear the statement ``Excess consumption may have a laxative
(f) In accordance with Sec. 180.1, adequate and appropriate feeding
studies have been undertaken for this substance. Continued uses of this
ingredient are contingent upon timely and adequate progress reports of
such tests, and no indication of increased risk to public health during
the test period.
(g) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61
FR 7991, Mar. 1, 1996; 69 FR 65542, Nov. 15, 2004]
Additives that reference this regulation: