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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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Part 184 - Direct Food Substances Affirmed as Generally Recognized as Safe |
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Subpart B - Listing of Specific Substances Affirmed as GRAS |
§ 184.1660 - Propyl gallate.
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§ 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/federal_register/code_of_federal_regulations/ibr_locations.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]