Sucrose Oligoesters

Food and Drug Administration, HHS § 172.869

National Archives and Records Admin- (a) The food additive is a cellulose istration (NARA). For information on ether containing ethoxy (OC2H5) groups the availability of this material at attached by an ether linkage and con- NARA, call 202–741–6030 or go to: http:// taining on an anhydrous basis not more www.archives.gov/federal-register/cfr/ibr- than 2.6 ethoxy groups per locations.html. anhydroglucose unit. (c) Olestra may be used in place of (b) It is used or intended for use as fats and oils in prepackaged ready-to- follows: eat savory (i.e., salty or piquant but (1) As a binder and filler in dry vita- not sweet) snacks and prepackaged, min preparations. unpopped popcorn kernels that are (2) As a component of protective ready-to-heat. In such foods, the addi- coatings for vitamin and mineral tab- tive may be used in place of fats and lets. oils for frying or baking, in dough con- (3) As a fixative in flavoring com- ditioners, in sprays, in filling ingredi- pounds. ents, or in flavors. (d) To compensate for any inter- § 172.869 Sucrose oligoesters. ference with absorption of fat soluble vitamins, the following vitamins shall Sucrose oligoesters, as identified in be added to foods containing olestra: this section, may be safely used in ac- 1.9 milligrams alpha-tocopherol equiva- cordance with the following conditions: lents per gram olestra; 51 retinol (a) Sucrose oligoesters consist of equivalents per gram olestra (as mixtures of sucrose fatty acid esters retinyl acetate or retinyl palmitate); 12 with an average degree of IU vitamin D per gram olestra; and 8 μg esterification ranging from four to vitamin K1 per gram olestra. seven. It is produced by (e)(1) Vitamins A, D, E, and K present interesterification of sucrose with in foods as a result of the requirement methyl esters of fatty acids derived in paragraph (d) of this section shall be from edible fats and oils (including hy- declared in the listing of ingredients. drogenated fats and oils). The only sol- Such vitamins shall not be considered vents which may be used in the prepa- in determining nutrient content for the ration of sucrose oligoesters are di- nutritional label or for any nutrient methyl sulfoxide, isobutyl alcohol, and claims, express or implied. those solvents generally recognized as (i) An asterisk shall follow vitamins safe in food. A, D, E, and K in the listing of ingredi- (b) Sucrose oligoesters meet the spec- ents; ifications in the methods listed in the (ii) The asterisk shall appear as a su- table in this paragraph. The methods perscript following each vitamin; for determining compliance with each (iii) Immediately following the ingre- specification are incorporated by ref- dient list an asterisk and statement, erence. The Director of the Office of ‘‘Dietarily insignificant’’ shall appear the Federal Register approves this in- prominently and conspicuously as spec- corporation by reference in accordance ified in § 101.2(c) of this chapter; with 5 U.S.C. 552(a) and 1 CFR part 51. (2) Olestra shall not be considered as Copies may be examined at the Food a source of fat or calories for purposes and Drug Administration’s Main Li- of §§ 101.9 and 101.13 of this chapter. brary, 10903 New Hampshire Ave., Bldg. [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 2, Third Floor, Silver Spring, MD 20993, 1996, as amended at 68 FR 46402, Aug. 5, 2003; 301–796–2039, or at the National Ar- 69 FR 29432, May 24, 2004; 78 FR 71465, Nov. 29, chives and Records Administration 2013] (NARA). For information on the availability of this material at NARA, call § 172.868 Ethyl cellulose. 202–741–6030 or go to: http:// The food additive ethyl cellulose may www.archives.gov/federal-register/cfr/ibr- be safely used in food in accordance locations.html. Copies of the methods with the following prescribed condi- are available from the sources listed in tions: the table in this paragraph:

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Specification Limit Method Cited Source for Obtaining Method

(1) Sucrose esters ...... Not less than 90% ...... ‘‘Method for Analyzing the Pu- Office of Food Additive Safe- rity of Sucrose Fatty Acid ty, Center for Food Safety Esters,’’ issued by and Applied Nutrition (HFS– Mitsubishi Chemical Corp., 200), Food and Drug Ad- June 17, 1998. ministration, 5100 Paint Branch Pkwy., College Park, MD 20740.

(2) Mono-, di-, and tri-esters ... Not more than 45% ...... ‘‘Method for Measuring the Do. Ester Distribution of Su- crose Oligoesters,’’ issued by Mitsubishi Chemical Corp., June 17, 1998.

(3) Tetra-, penta-, hexa-, and Not less than 50% ...... Do. Do. hepta-esters.

(4) Octa-esters ...... Not more than 40% ...... Do. Do.

(5) Free Sucrose ...... Not more than 0.5% ...... ‘‘Free Sucrose Method,’’ Do. issued by Mitsubishi Chem- ical Corp., June 17, 1998.

(6) Acid Value ...... Not more than 4.0 ...... ‘‘Acid Value,’’ Appendix VII, United States Pharmacopeial Method I (Commercial Fatty Convention, 12601 Acids), in the Food Chemi- Twinbrook Pkwy., Rockville, cals Codex, 7th ed. (2010), MD 20852 (Internet address p. 1220. http://www.usp.org)

(7) Residue on Ignition ...... Not more than 0.7% ...... ‘‘Residue on Ignition,’’ Appen- Do. dix IIC, Method I, in the Food Chemicals Codex, 7th ed. (2010), pp. 1141–1142 (using a 1-gram sample).

(8) Residual Methanol ...... Not more than 10 milligrams/ Method listed in the mono- Do kilogram. graph for ‘‘Sucrose Fatty Acid Esters’’ in the Food Chemicals Codex, 7th ed. (2010), pp. 998–1000.

(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ ...... do Do. oxide. kilogram.

(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ ...... do Do. kilogram.

(11) Lead ...... Not more than 1.0 milligram/ ‘‘Atomic Absorption Do. kilogram. Spectrophometric Graphite Furnace Method,’’ Method I in the Food Chemicals Codex, 7th ed. (2010), p. 1154–1155

(c) The additive is used as an emulsi- § 172.870 Hydroxypropyl cellulose. fier (as defined in § 170.3(o)(8) of this The food additive hydroxypropyl cel- chapter) or stabilizer (as defined in lulose may be safely used in food, ex- § 170.3(o)(28) of this chapter) in choco- cept standardized foods that do not late and in butter-substitute spreads, provide for such use, in accordance at a level not to exceed 2.0 percent; ex- with the following prescribed condi- cept that the additive may not be used tions: in a standardized food unless permitted (a) The additive consists of one of the by the standard of identity. following: [68 FR 50072, Aug. 20, 2003, as amended at 78 (1) A cellulose ether containing pro- FR 71465, Nov. 29, 2013] pylene glycol groups attached by an ether linkage that contains, on an anhydrous basis, not more than 4.6

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