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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 2015.

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, 2015]
[CITE: 21CFR184.1666]



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. 184.1666 Propylene glycol.

(a) Propylene glycol (C3H8O2, CAS Reg. No. 57-55-6) is known as 1,2-propanediol. It does not occur in nature. Propylene glycol is manufactured by treating propylene with chlorinated water to form the chlorohydrin which is converted to the glycol by treatment with sodium carbonate solution. It is also prepared by heating glyercol with sodium hydroxide.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 255, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418. It is also available for inspection 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 as defined in 170.3(o)(1) of this chapter; antioxidant as defined in 170.3(o)(3) of this chapter; dough strengthener as defined in 170.3(o)(6) of this chapter; emulsifier as defined in 170.3(o)(8) of this chapter; flavor agent 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; processing aid as defined in 170.3(o)(24) of this chapter; solvent and vehicle as defined in 170.3(o)(27) of this chapter; stabilizer and thickener as defined in 170.3(o)(28) of this chapter; surface-active agent as defined in 170.3(o)(29) of this chapter; and texturizer as defined in 170.3(o)(32) of this chapter.

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 5 percent for alcoholic beverages, as defined in 170.3(n)(2) of this chapter; 24 percent for confections and frostings as defined in 170.3(n)(9) of this chapter; 2.5 percent for frozen dairy products as defined in 170.3(n)(20) of this chapter; 97 percent for seasonings and flavorings as defined in 170.3(n)(26) of this chapter; 5 percent for nuts and nut products as defined in 170.3(n)(32) of this chapter; and 2.0 percent for all other food categories.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[47 FR 27812, June 25, 1982]

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