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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR184.1835]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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 170.3(o)(1) of this chapter, curing and pickling agent as defined in 170.3(o)(5) of this chapter, drying agent as defined in 170.3(o)(7) of this chapter, emulsifier and emulsifier salt as defined in 170.3(o)(8) of this chapter, firming agent as defined in 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in 170.3(o)(12) of this chapter, formulation aid as defined in 170.3(o)(14) of this chapter, humectant as defined in 170.3(o)(16) of this chapter, lubricant and release agent as defined in 170.3(o)(18) of this chapter, nutritive sweetener as defined in 170.3(o)(21) of this chapter, sequestrant as defined in 170.3(o)(26) of this chapter, stabilizer and thickener as defined in 170.3(o)(28) of this chapter, surface-finishing agent as defined in 170.3(o)(30) of this chapter, and texturizer as defined in 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 170.3(n)(25) of this chapter, 75 percent in chewing gum as defined in 170.3(n)(6) of this chapter, 98 percent in soft candy as defined in 170.3(n)(38) of this chapter, 30 percent in nonstandardized jams and jellies, commercial, as defined in 170.3(n)(28) of this chapter, 30 percent in baked goods and baking mixes as defined in 170.3(n)(1) of this chapter, 17 percent in frozen dairy desserts and mixes as defined in 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]

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