Food and Drug Administration, HHS § 180.30

forth in paragraph (a) of this section in § 170.3(o)(24) of this chapter, sta- and shall be subject to the require- bilizer and thickener as defined in ments of paragraph (b) of this section. § 170.3(o)(28) of this chapter, surface-fin- (g) In addition to the requirements of ishing agent as defined in § 170.3(o)(30) this section, the use of acrylonitrile co- of this chapter, and texturizer as de- polymers shall comply with all applica- fined in § 170.3(o)(32) of this chapter. ble requirements in other regulations (d) The ingredient is used in food at in this part. levels not to exceed 98 percent in pressed mints and 5 percent in all other [42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, hard candy and cough drops as defined 1989; 61 FR 14246, Apr. 1, 1996] in § 170.3(n)(25) of this chapter, 31 per- cent in chewing gum as defined in § 180.25 Mannitol. § 170.3(n)(6) of this chapter, 40 percent (a) Mannitol is the chemical in soft candy as defined in § 170.3(n)(38) of this chapter, 8 percent in confections 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sor- and frostings as defined in § 170.3(n)(9) bitol principally by having a different of this chapter, 15 percent in non- optical rotation. Mannitol is produced standardized jams and jellies, commer- by one of the following processes: cial, as defined in § 170.3(n)(28) of this (1) The electrolytic reduction or chapter, and at levels less than 2.5 per- transition metal catalytic hydro- cent in all other foods. genation of sugar solutions containing (e) The label and labeling of food glucose or fructose. whose reasonably foreseeable consump- (2) The fermentation of sugars or tion may result in a daily ingestion of sugar alcohols such as glucose, sucrose, 20 grams of mannitol shall bear the fructose, or sorbitol using the yeast statement ‘‘Excess consumption may Zygosaccharomyces rouxii. have a laxative effect’’. (3) A pure culture fermentation of (f) In accordance with § 180.1, ade- sugars such as fructose, glucose, or quate and appropriate feeding studies maltose using the nonpathogenic, have been undertaken for this sub- nontoxicogenic bacterium Lactobacillus stance. Continued uses of this ingre- intermedius (fermentum). dient are contingent upon timely and (b) The ingredient meets the speci- adequate progress reports of such tests, fications of the ‘‘Food Chemicals and no indication of increased risk to Codex,’’ 3d Ed. (1981), pp. 188–190, which public health during the test period. is incorporated by reference. Copies (g) Prior sanctions for this ingredient may be obtained from the National different from the uses established in Academy Press, 2101 Constitution Ave. this regulation do not exist or have NW., Washington, DC 20418, or may be been waived. examined at the National Archives and [42 FR 14636, Mar. 15, 1977, as amended at 49 Records Administration (NARA). For FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; information on the availability of this 69 FR 65542, Nov. 15, 2004] material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ § 180.30 Brominated vegetable oil. federallregister/ The food additive brominated vege- codeloflfederallregulations/ table oil may be safely used in accord- ibrllocations.html. ance with the following prescribed con- (c) The ingredient is used as an ditions: anticaking agent and free-flow agent as (a) The additive complies with speci- defined in § 170.3(o)(1) of this chapter, fications prescribed in the ‘‘Food formulation aid as defined in § 170.3(o) Chemicals Codex,’’ 3d Ed. (1981), pp. 40– (14) of this chapter, firming agent as 41, which is incorporated by reference, defined in § 170.3(o)(10) of this chapter, except that free fatty acids (as oleic) flavoring agent and adjuvant as defined shall not exceed 2.5 percent and iodine in § 170.3(o)(12) of this chapter, lubri- value shall not exceed 16. Copies of the cant and release agent as defined in material incorporated by reference § 170.3(o)(18) of this chapter, nutritive may be obtained from the National sweetener as defined in § 170.3(o)(21) of Academy Press, 2101 Constitution Ave. this chapter, processing aid as defined NW., Washington, DC 20418, or may be

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examined at the National Archives and Main Library, 10903 New Hampshire Records Administration (NARA). For Ave., Bldg. 2, Third Floor, Silver information on the availability of this Spring, MD 20993, 301–796–2039, or at the material at NARA, call 202–741–6030, or National Archives and Records Admin- go to: http://www.archives.gov/ istration (NARA). For information on federallregister/ the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030 or go to: http:// ibrllocations.html. www.archives.gov/federal-register/cfr/ibr- (b) The additive is used on an interim locations.html. basis as a stabilizer for flavoring oils (c) Authority for such use shall ex- used in fruit-flavored beverages, for pire when the Commissioner receives which any applicable standards of iden- the final reports on the ongoing studies tity do not preclude such use, in an in Canada and publishes an order on amount not to exceed 15 parts per mil- the safety of saccharin and its salts lion in the finished beverage, pending based on those reports and other avail- the outcome of additional toxicological able data. studies on which periodic reports at 6- month intervals are to be furnished (d) The additives are used or intended and final results submitted to the Food for use as a sweetening agent only in and Drug Administration promptly special dietary foods, as follows: after completion of the studies. (1) In beverages, fruit juice drinks, and bases or mixes when prepared for [42 FR 14636, Mar. 15, 1977, as amended at 49 consumption in accordance with direc- FR 5610, Feb. 14, 1984] tions, in amounts not to exceed 12 mil- § 180.37 Saccharin, ammonium sac- ligrams of the additive, calculated as charin, calcium saccharin, and so- saccharin, per fluid ounce. dium saccharin. (2) As a sugar substitute for cooking The food additives saccharin, ammo- or table use, in amounts not to exceed nium saccharin, calcium saccharin, and 20 milligrams of the additive, cal- sodium saccharin may be safely used as culated as saccharin, for each ex- sweetening agents in food in accord- pressed teaspoonful of sugar sweet- ance with the following conditions, if ening equivalency. the substitution for nutritive sweet- (3) In processed foods, in amounts not eners is for a valid special dietary pur- to exceed 30 milligrams of the additive, pose and is in accord with current spe- calculated as saccharin, per serving of cial dietary food regulations and poli- designated size. cies or if the use or intended use is for (e) The additives are used or intended an authorized technological purpose for use only for the following techno- other than calorie reduction: logical purposes: (a) Saccharin is the chemical, 1,2- (1) To reduce bulk and enhance fla- benzisothiazolin-3-one - 1,1 - dioxide vors in chewable vitamin tablets, (C7H5NO3S). The named salts of sac- chewable mineral tablets, or combina- charin are produced by the additional tions thereof. neutralization of saccharin with the (2) To retain flavor and physical proper base to yield the desired salt. properties of chewing gum. (b) The food additives meet the speci- (3) To enhance flavor of flavor chips fications of the Food Chemicals Codex, 7th ed. (2010), pp. 52–54, 153–154, 898–899, used in nonstandardized bakery prod- 961–962, which is incorporated by ref- ucts. erence. The Director of the Office of (f) To assure safe use of the additives, the Federal Register approves this in- in addition to the other information re- corporation by reference in accordance quired by the Act: with 5 U.S.C. 552(a) and 1 CFR part 51. (1) The label of the additive and any You may obtain copies from the United intermediate mixes of the additive for States Pharmacopeial Convention, manufacturing purposes shall bear: 12601 Twinbrook Pkwy., Rockville, MD (i) The name of the additive. 20852 (Internet address http:// (ii) A statement of the concentration www.usp.org). Copies may be examined of the additive, expressed as saccharin, at the Food and Drug Administration’s in any intermediate mix.

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