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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 2018.

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, 2018]
[CITE: 21CFR184.1230]



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. 184.1230 Calcium sulfate.

(a) Calcium sulfate (CaSO4, CAS Reg. No. 7778-18-9 or CaSO4.2H2O, CAS Reg. No. 10101-41-4), also known as plaster of Paris, anhydrite, and gypsum, occurs naturally and exists as a fine, white to slightly yellow-white odorless powder. The anhydrous form is prepared by complete dehydration of gypsum, below 300 deg. C, in an electric oven.

(b) The ingredient meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981), p. 66, 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 as defined in 170.3(o)(1) of this chapter, color and coloring adjunct as defined in 170.3(o)(4) of this chapter, dough strengthener as defined in 170.3(o)(6) of this chapter, drying agent as defined in 170.3(o)(7) of this chapter, firming agent as defined in 170.3(o)(10) of this chapter, flour treating agent as defined in 170.3(o)(13) of this chapter, formulation aid as defined in 170.3(o)(14) of this chapter, leavening agent as defined in 170.3(o)(17) of this chapter, nutrient supplement as defined in 170.3(o)(20) of this chapter, pH control agent as defined in 170.3(o)(23) of this chapter, processing aid as defined in 170.3(o)(24) of this chapter, stabilizer and thickener as defined in 170.3(o)(28) of this chapter, synergist as defined in 170.3(o)(31) 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 practice in accordance with 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 1.3 percent for baked goods as defined in 170.3(n)(1) of this chapter, 3.0 percent for confections and frostings as defined in 170.3(n)(9) of this chapter, 0.5 percent for frozen dairy desserts and mixes as defined in 170.3(n)(20) of this chapter, 0.4 percent for gelatins and puddings as defined in 170.3(n)(22) of this chapter, 0.5 percent for grain products and pastas as defined in 170.3(n)(23) of this chapter, 0.35 percent for processed vegetables as defined in 170.3(n)(36) of this chapter, and 0.07 percent or less 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.

[45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, 1980, as amended at 49 FR 5611, Feb. 14, 1984]

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