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180.25 Mannitol.

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[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: 21CFR180.25]

[Page 459-460]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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,

[[Page 460]]

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. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined 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) 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 
chapter.
    (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 
effect''.
    (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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 180, Section 25


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