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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR184.1259]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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 (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 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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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 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, 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, 5001 Campus Dr., 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 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 170.3(n)(9) of this chapter; coatings of soft candy as defined in 170.3(n)(38) of this chapter; and sweet sauces and toppings as defined in 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 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; 78 FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, 2016]

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