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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 2019.

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, 2019]
[CITE: 21CFR184.1660]



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. 184.1660 Propyl gallate.

(a) Propyl gallate is the n -propylester of 3,4,5-trihydroxybenzoic acid (C10H12O5). Natural occurrence of propyl gallate has not been reported. It is commercially prepared by esterification of gallic acid with propyl alcohol followed by distillation to remove excess alcohol.

(b) The ingredient meets the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 257-258, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(c) The ingredient is used as an antioxidant as defined in 170.3(o)(3) 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). Good manufacturing practice results in a maximum total content of antioxidants of 0.02 percent of the fat or oil content, including the essential (volatile) oil content, of the food.

(e) Prior sanctions for this ingredient different from the uses established in this section, or different from that stated in part 181 of this chapter, do not exist or have been waived.

[42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, 1984]

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