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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 2017.

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, 2017]
[CITE: 21CFR172.723]



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 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart H--Other Specific Usage Additives

Sec. 172.723 Epoxidized soybean oil.

Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions:

(a) The additive is prepared by reacting soybean oil in toluene with hydrogen peroxide and formic acid.

(b) It meets the following specifications:

(1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American Oil Chemists' Society (A.O.C.S.) method Cd 9-57, "Oxirane Oxygen," reapproved 1989, which is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. Copies are available from the American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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) The maximum iodine value is 3.0, as determined by A.O.C.S. method Cd 1-25, "Iodine Value of Fats and Oils Wijs Method," revised 1993, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(3) The heavy metals (as Pb) content cannot be more than 10 parts per million, as determined by the "Heavy Metals Test," of the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761, Method II (with a 2-gram sample and 20 microgram of lead ion in the control), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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.

(c) The additive is used as a halogen stabilizer in brominated soybean oil at a level not to exceed 1 percent.

[60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016]

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