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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 2017.

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, 2017]
[CITE: 21CFR172.859]



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 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

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, 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.

(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, 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.

(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 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.

(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, 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.

(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, 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) 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 170.3(o)(8) of this chapter, or as stabilizers as defined in 170.3(o)(28) of this chapter, in baked goods and baking mixes as defined in 170.3(n)(1) of this chapter, in chewing gum as defined in 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 170.3(n)(9) of this chapter, in dairy product analogues as defined in 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes as defined in 170.3(n)(20) of this chapter, and in whipped milk products.

(2) As texturizers as defined in 170.3(o)(32) of this chapter in biscuit mixes, in chewing gum as defined in 170.3(n)(6) of this chapter, in confections and frostings as defined in 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]

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