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172.869 Sucrose oligoesters.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.869]

[Page 106-107]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN 
CONSUMPTION--Table of Contents
 
                    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 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:

----------------------------------------------------------------------------------------------------------------
                                                                                           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).
----------------------------------------------------------------------------------------------------------------

[[Page 107]]


(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.
----------------------------------------------------------------------------------------------------------------

    (c) The additive is used as an emulsifier (as defined in Sec.  
170.3(o)(8) of this chapter) or stabilizer (as defined in Sec.  
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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 172, Section 869


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