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 esters | Not 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-esters | Not 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-esters | Not less than 50% | Do. | Do. |
| (4) Octa-esters | Not more than 40% | Do. | Do. |
| (5) Free Sucrose | Not more than 0.5% | “Free Sucrose Method,” issued by Mitsubishi Chemical Corp., June 17, 1998. | Do. |
| (6) Acid Value | Not 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 Ignition | Not 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 Methanol | Not more than 10 milligrams/kilogram | Method listed in the monograph for “Sucrose Fatty Acid Esters” in the Food Chemicals Codex, 7th ed. (2010), pp. 998-1000. | Do |
| (9) Residual Dimethyl Sulfoxide | Not more than 2.0 milligrams/kilogram | ......do | Do. |
| (10) Residual Isobutyl Alcohol | Not more than 10 milligrams/kilogram | ......do | Do. |
| (11) Lead | Not more than 1.0 milligram/kilogram | “Atomic Absorption Spectrophometric Graphite Furnace Method,” Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154-1155 | Do. |
(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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