21 C.F.R. § 172.869

Current through September 30, 2024

Section 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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," Chemical Corp., June 17, 1998	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.
(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.

21 C.F.R. §172.869

68 FR 50072, Aug. 20, 2003, as amended at 78 FR 71465, Nov. 29, 2013; 88 FR 17721, Mar. 24, 2023

88 FR 17721, 3/24/2023