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§ 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 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.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, 5100 Paint Branch Pkwy., 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. | Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. |
| (3) Tetra-, penta-, hexa-, and hepta-esters | Not less than 50% | “Method for Measuring the Ester Distribution of Sucrose Oligoesters,” 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, 5100 Paint Branch Pkwy., College Park, MD 20740. |
| (4) Octa-esters | Not more than 40% | “Method for Measuring the Ester Distribution of Sucrose Oligoesters,” 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, 5100 Paint Branch Pkwy., College Park, MD 20740. |
| (5) Free Sucrose | Not more than 0.5% | “Free Sucrose Method,” 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, 5100 Paint Branch Pkwy., College Park, MD 20740. |
| (6) Acid Value | Not more than 4.0 | “Acid Value,” Appendix VII, Method I (Commercial Fatty Acids), in the Food Chemicals Codex, 4th ed. (1996), p. 820. | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
| (7) Residue on Ignition | Not more than 0.7% | “Residue on Ignition, Appendix IIC, Method I, in the Food Chemicals Codex, 4th ed. (1996), pp. 751–752, (using a 1-gram sample). | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
| (8) Residual Methanol | Not more than 10 milligrams/kilogram | Method listed in the monograph for “Sucrose Fatty Acid Esters” in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45. | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
| (9) Residual Dimethyl Sulfoxide | Not more than 2.0 milligrams/kilogram | Method listed in the monograph for “Sucrose Fatty Acid Esters” in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45. | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
| (10) Residual Isobutyl Alcohol | Not more than 10 milligrams/kilogram | Method listed in the monograph for “Sucrose Fatty Acid Esters” in the First Supplement to the 4th ed. of the Food Chemicals Codex (1997), pp. 44–45. | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
| (11) Lead | Not more than 1.0 milligram/kilogram | National Academy Press, 2101 Constitution Ave. NW, Washington, DC 20418 (Internet: http://www.nap.edu ). |
（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]
更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规，请点击美国FDA 21 CFR 第172部分已批准的直接用于人类食品的添加剂种类汇总
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