[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1259]
[Page 511-512]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 184 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
Subpart B Listing of Specific Substances Affirmed as GRAS
Sec. 184.1259 Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is ``cocoa butter substitute primarily from palm oil.''
The common or usual name for the triglyceride 1-3-distearoyl-2-olein is
``cocoa butter substitute primarily from high-oleic safflower or
sunflower oil.''
(1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured
by:
(i) Directed esterification of fully saturated 1,3-diglycerides
(derived from palm oil) with the anhydride of food-grade oleic acid in
the presence of the catalyst trifluoromethane sulfonic acid (Sec.
173.395 of this chapter), or
(ii) By interesterification of partially saturated 1,2,3-
triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation that is either
generally recognized as safe (GRAS) or has food additive approval for
such use.
(2) The ingredient 1-3-distearoyl-2-olein is manufactured by
interesterification of partially unsaturated 1,2,3-triglycerides
(derived from high-oleic safflower or sunflower oil) with ethyl stearate
or stearic acid in the presence of a suitable lipase enzyme preparation
that is either GRAS or has food additive approval for such use.
(b) The ingredient meets the following specifications:
(1) Over 90 percent triglycerides, not more than 7 percent
diglycerides, not more than 1 percent monoglycerides, and not more than
1 percent free fatty acids.
(2) Total glycerides--98 percent minimum.
(3) Heavy metals (as lead), not more than 10 milligrams per
kilogram, as determined by the Heavy Metals Test of the ``Food Chemicals
Codex,'' 4th ed. (1996), pp. 760-761, which is incorporated by reference
in accordance with 5
[[Page 512]]
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National
Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055
(Internet address http://www.nap.edu), or may be examined at the Center
for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 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.
(4) Color--clear, bright, and free from suspended matter.
(5) Odor and taste--free from foreign and rancid odor and taste.
(6) Residual catalyst (``Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), sections
25.049-25.055, which is incorporated by reference), residual fluorine;
limit of detection 0.2 part per million F; multiply fluoride result by
2.63 to convert to residual catalyst. Copies of the material
incorporated by reference may be obtained from the AOAC INTERNATIONAL,
481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be
examined 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. The ingredient shall be washed
three times in batches with 0.5 percent sodium bicarbonate to remove
catalyst residuals in accordance with good manufacturing practice.
(7) Residual methanol--5 parts per million maximum.
(8) Residual fatty acid ethyl esters--not more than 20 parts per
million as determined by a ``Modification of Japan Institute of Oils and
Fats: Analysis Method of Residual Ethyl Esters of Fatty Acids'' issued
by the Fuji Oil Co., which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, 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.
(9) Hexane--not more than 5 parts per million as determined by the
method of Dupuy et al., ``Rapid Quantitative Determination of Residual
Hexane in Oils by Direct Gas Chromatography,'' published in the
``Journal of the American Oil Chemists' Society,'' Vol. 52, p. 118.120,
1975, which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, 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) In accordance with Sec. 184.1(b)(1), the ingredient is used in
the following food categories at levels not to exceed current good
manufacturing practice: Confections and frostings as defined in Sec.
170.3(n)(9) of this chapter; coatings of soft candy as defined in Sec.
170.3(n)(38) of this chapter; and sweet sauces and toppings as defined
in Sec. 170.3(n)(43) of this chapter; except that the ingredient may
not be used in a standardized food unless permitted by the standard of
identity.
(d) The ingredient is used in food in accordance with Sec.
184.1(b)(1) at levels not to exceed good manufacturing practice.
[43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19, 1982;
49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR 47920, Dec.
17, 1987; 52 FR 48905, Dec. 28, 1987; 61 FR 36290, July 10, 1996; 64 FR
1760, Jan. 12, 1999]
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