172.736—Glycerides and polyglycides of hydrogenated vegetable oils.
The food additive glycerides and polyglycides of hydrogenated vegetable oils may be safely used in food in accordance with the following prescribed conditions:
(a)
The additive is manufactured by heating a mixture of hydrogenated oils of vegetable origin and polyethylene glycol in the presence of an alkaline catalyst followed by neutralization with any acid that is approved or is generally recognized as safe for this use to yield the finished product.
(b)
The additive consists of a mixture of mono-, di- and tri-glycerides and polyethylene glycol mono- and di-esters of fatty acids (polyglycides) of hydrogenated vegetable oils and meets the following specifications:
(1)
Total ester content, greater than 90 percent as determined by a method entitled “Determination of Esterified Glycerides and Polyoxyethylene Glycols,” approved November 16, 2001, printed by Gattefosse S.A.S., and incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety, 5100 Paint Branch Pkwy., College Park, MD 20740 or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.
(2)
Acid value, not greater than 2, and hydroxyl value, not greater than 56 as determined by the methods entitled “Acid Value,” p. 934 and “Hydroxyl Value,” p. 936, respectively, in the Food Chemicals Codex, 5th ed., effective January 1, 2004, and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academies Press, 500 Fifth St. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.
(3)
Lead, not greater than 0.1 mg/kg as determined by the American Oil Chemists' Society (A.O.C.S.) method Ca 18c-91, “Determination of Lead by Direct Graphite Furnace Atomic Absorption Spectrophotometry,” updated 1995, and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined in the library at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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.
(4)
1,4-Dioxane, not greater than 10 milligrams per kilogram (mg/kg), and ethylene oxide, not greater than 1 mg/kg, as determined by a gas chromatographic method entitled “Determination of Ethylene Oxide and 1,4-Dioxane by Headspace Gas Chromatography,” approved November 5, 1998, printed by Gattefosse S.A.S., and incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51; see paragraph (b)(1) of this section for availability of the incorporation by reference.
(c)
The additive is used or intended for use as an excipient in dietary supplement tablets, capsules, and liquid formulations that are intended for ingestion in daily quantities measured in drops or similar small units of measure.