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184.1835 Sorbitol.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1835 Sorbitol.



[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: 21CFR184.1835]

[Page 568]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1835  Sorbitol.

    (a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol 
(C6H14O6), a hexahydric alcohol, 
differing from mannitol principally by having a different optical 
rotation. Sorbitol is produced by the electrolytic reduction, or the 
transition metal catalytic hydrogenation of sugar solutions containing 
glucose or fructose.
    (b) The ingredient meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), p. 308, 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, curing and 
pickling agent as defined in Sec.  170.3(o)(5) of this chapter, drying 
agent as defined in Sec.  170.3(o)(7) of this chapter, emulsifier and 
emulsifier salt as defined in Sec.  170.3(o)(8) 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, 
formulation aid as defined in Sec.  170.3(o)(14) of this chapter, 
humectant as defined in Sec.  170.3(o)(16) 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, 
sequestrant as defined in Sec.  170.3(o)(26) 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 good 
manufacturing practices. Current good manufacturing practice in the use 
of sorbitol results in a maximum level of 99 percent in hard candy and 
cough drops as defined in Sec.  170.3(n)(25) of this chapter, 75 percent 
in chewing gum as defined in Sec.  170.3(n)(6) of this chapter, 98 
percent in soft candy as defined in Sec.  170.3(n)(38) of this chapter, 
30 percent in nonstandardized jams and jellies, commercial, as defined 
in Sec.  170.3(n)(28) of this chapter, 30 percent in baked goods and 
baking mixes as defined in Sec.  170.3(n)(1) of this chapter, 17 percent 
in frozen dairy desserts and mixes as defined in Sec.  170.3(n)(20) of 
this chapter, and 12 percent in all other foods.
    (e) The label and labeling of food whose reasonably foreseeable 
consumption may result in a daily ingestion of 50 grams of sorbitol 
shall bear the statement: ``Excess consumption may have a laxative 
effect.''
    (f) Prior sanctions for this ingredient different from the uses 
established in this regulation do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1835


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