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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: 21CFR172.869]



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 I--Multipurpose Additives

Sec. 172.869 Sucrose oligoesters.

Sucrose oligoesters, as identified in this section, may be safely used in accordance with the following conditions:

(a) Sucrose oligoesters consist of mixtures of sucrose fatty acid esters with an average degree of esterification ranging from four to seven. It is produced by interesterification of sucrose with methyl esters of fatty acids derived from edible fats and oils (including hydrogenated fats and oils). The only solvents which may be used in the preparation of sucrose oligoesters are dimethyl sulfoxide, isobutyl alcohol, and those solvents generally recognized as safe in food.

(b) Sucrose oligoesters meet the specifications in the methods listed in the table in this paragraph. The methods for determining compliance with each specification are 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. Copies 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/cfr/ibr-locations.html. Copies of the methods are available from the sources listed in the table in this paragraph:

Specification Limit Method Cited Source for Obtaining Method
(1) Sucrose estersNot less than 90%"Method for Analyzing the Purity of Sucrose Fatty Acid Esters," issued by Mitsubishi Chemical Corp., June 17, 1998.Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.
(2) Mono-, di-, and tri-estersNot more than 45%"Method for Measuring the Ester Distribution of Sucrose Oligoesters," issued by Mitsubishi Chemical Corp., June 17, 1998.Do.
(3) Tetra-, penta-, hexa-, and hepta-estersNot less than 50%Do.Do.
(4) Octa-estersNot more than 40%Do.Do.
(5) Free SucroseNot more than 0.5%"Free Sucrose Method," issued by Mitsubishi Chemical Corp., June 17, 1998.Do.
(6) Acid ValueNot more than 4.0"Acid Value," Appendix VII, Method I (Commercial Fatty Acids), in the Food Chemicals Codex, 7th ed. (2010), p. 1220.United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org)
(7) Residue on IgnitionNot more than 0.7%"Residue on Ignition," Appendix IIC, Method I, in the Food Chemicals Codex, 7th ed. (2010), pp. 1141-1142 (using a 1-gram sample).Do.
(8) Residual MethanolNot more than 10 milligrams/kilogramMethod listed in the monograph for "Sucrose Fatty Acid Esters" in the Food Chemicals Codex, 7th ed. (2010), pp. 998-1000.Do
(9) Residual Dimethyl SulfoxideNot more than 2.0 milligrams/kilogram......doDo.
(10) Residual Isobutyl AlcoholNot more than 10 milligrams/kilogram......doDo.
(11) LeadNot more than 1.0 milligram/kilogram"Atomic Absorption Spectrophometric Graphite Furnace Method," Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154-1155Do.

(c) The additive is used as an emulsifier (as defined in 170.3(o)(8) of this chapter) or stabilizer (as defined in 170.3(o)(28) of this chapter) in chocolate and in butter-substitute spreads, at a level not to exceed 2.0 percent; except that the additive may not be used in a standardized food unless permitted by the standard of identity.

[68 FR 50072, Aug. 20, 2003, as amended at 78 FR 71465, Nov. 29, 2013]

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