[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: 21CFR172.859]
[Page 98-99]
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. 172.859 Sucrose fatty acid esters.
Sucrose fatty acid esters identified in this section may be safely
used in accordance with the following prescribed conditions:
(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of
sucrose with fatty acids and are derived from sucrose and edible tallow
or hydrogenated edible tallow or edible vegetable oils. The only
solvents which may be used in the preparation of sucrose fatty acid
esters are those generally recognized as safe in food or regulated for
such use by an appropriate section in this part. Ethyl acetate or methyl
ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-
propanol) may be used in the preparation of sucrose fatty acid esters.
(b) Sucrose fatty acid esters meet the following specifications:
(1) The total content of mono-, di-, and tri-esters is not less than
80 percent as determined by a method title ``Sucrose Fatty Acid Esters,
Method of Assay,'' which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection 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.
(2) The free sucrose content is not more than 5 percent as
determined by Test S.2 in the method titled ``Sucrose Fatty Acid Esters,
Method of Assay,'' which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (b)(1) of this
section.
(3) The acid value is not more than 6.
(4) The residue on ignition (sulfated ash) is not more than 2
percent.
(5) The total ethyl acetate content is not more than 350 parts per
million as determined by a method titled ``Determination of Ethyl
Acetate,'' which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection 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.
(6) Arsenic is not more than 3 parts per million.
(7) Total heavy metal content (as Pb) is not more than 50 parts per
million.
(8) Lead is not more than 10 parts per million.
(9) The total content of methyl ethyl ketone or of methanol shall
not be more than 10 parts per million as determined by a method titled
``Methyl Ethyl Ketone Test; Methyl Alcohol Test,'' which is incorporated
by reference. Copies are available from the
[[Page 99]]
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection 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.
(10) The total dimethyl sulfoxide content is not more than 2 parts
per million as determined by a method entitled ``Determination of
Dimethyl Sulfoxide,'' which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or available for inspection 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.
(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not
more than 10 parts per million as determined by a method entitled
``Determination of Isobutyl Alcohol,'' which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection 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.
(c) Sucrose fatty acid esters may be used as follows when standards
of identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter,
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter,
in coffee and tea beverages with added dairy ingredients and/or dairy
product analogues, in confections and frostings as defined in Sec.
170.3(n)(9) of this chapter, in dairy product analogues as defined in
Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes
as defined in Sec. 170.3(n)(20) of this chapter, and in whipped milk
products.
(2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of
this chapter, and in surimi-based fabricated seafood products.
(3) As components of protective coatings applied to fresh apples,
avocados, bananas, banana plantains, limes, melons (honeydew and
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard
ripening and spoiling.
(d) Sucrose fatty acid esters are used in accordance with current
good manufacturing practice and in an amount not to exceed that
reasonably required to accomplish the intended effect.
[47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23, 1983;
52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995]
Additives that reference this regulation: |
