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184.1259 Cocoa butter substitute.

Home > Regulations > Direct food substances affirmed as generally recognized as safe > 184.1259 Cocoa butter substitute.



[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: 21CFR184.1259]

[Page 510-511]
 
                        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 
SAFE--Table of Contents
 
        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 511]]

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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1259


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