21 C.F.R. § 172.869 Sucrose oligoesters.
Title 21 - Food and Drugs
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 cited for determining compliance with each specification are incorporated by reference, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the methods may be examined at the Center for Food Safety and Applied Nutrition's Library, room 1C–100, 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.php. Copies of the methods are available from the sources listed in the table in this paragraph: (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]
Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart I—Multipurpose Additives
§ 172.869 Sucrose oligoesters.
---------------------------------------------------------------------------------------------------------------- Source for Obtaining Specification Limit Method Cited Method----------------------------------------------------------------------------------------------------------------(1) Sucrose esters.................. Not less than 90%...... ``Method for Analyzing Office of Food the Purity of Sucrose Additive Safety, Fatty Acid Esters,'' Center for Food issued by Mitsubishi Safety and Applied Chemical Corp., June 17, Nutrition (HFS-200), 1998. Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.----------------------------------------------------------------------------------------------------------------(2) Mono-, di-, and tri-esters...... Not more than 45%...... ``Method for Measuring Do. the Ester Distribution of Sucrose Oligoesters,'' issued by Mitsubishi Chemical Corp., June 17, 1998.----------------------------------------------------------------------------------------------------------------(3) Tetra-, penta-, hexa-, and hepta- Not less than 50%...... Do. Do. esters.----------------------------------------------------------------------------------------------------------------(4) Octa-esters..................... Not more than 40%...... Do. Do.----------------------------------------------------------------------------------------------------------------(5) Free Sucrose.................... Not more than 0.5%..... ``Free Sucrose Method,'' Do. issued by Mitsubishi Chemical Corp., June 17, 1998.----------------------------------------------------------------------------------------------------------------(6) Acid Value...................... Not more than 4.0...... ``Acid Value,'' Appendix National Academy VII, Method I Press, 2101 (Commercial Fatty Constitution Ave. NW, Acids), in the Food Washington, DC 20418 Chemicals Codex, 4th ed. (Internet: http:// (1996), p. 820. www.nap.edu).----------------------------------------------------------------------------------------------------------------(7) Residue on Ignition............. Not more than 0.7%..... ``Residue on Ignition, Do. Appendix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751-752, (using a 1- gram sample).----------------------------------------------------------------------------------------------------------------(8) Residual Methanol............... Not more than 10 Method listed in the Do. milligrams/kilogram. monograph for ``Sucrose Fatty Acid Esters'' in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44-45.----------------------------------------------------------------------------------------------------------------(9) Residual Dimethyl Sulfoxide..... Not more than 2.0 Do. Do. milligrams/kilogram.----------------------------------------------------------------------------------------------------------------(10) Residual Isobutyl Alcohol...... Not more than 10 Do. Do. milligrams/kilogram.----------------------------------------------------------------------------------------------------------------(11) Lead........................... Not more than 1.0 ``Atomic Absorption Do. milligram/kilogram. Spectrophotometric Graphite Furnace Method,'' Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 763-765.----------------------------------------------------------------------------------------------------------------
