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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE > SUBPART B—Listing of Specific Substances Affirmed as GRAS (§184.1005 to §184.1985) > 184.1115—Agar-agar.

CFR

184.1115—Agar-agar.

(a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic, colloidal polysaccharide extracted from one of a number of related species of red algae (class Rhodophyceae ).
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 11, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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.
(c) The ingredient is used in food in accordance with § 184.1(b)(2) under the following conditions:
Maximum Usage Levels Permitted
Foods (as served) Percent Functions
Baked goods and baking mixes, § 170.3(n)(1) of this chapter 0.8 Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.
Confections and frostings, § 170.3(n)(9) of this chapter 2.0 Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter.
Soft candy, § 170.3(n)(38) of this chapter 1.2 Stabilizer and thickener, § 170.3(o)(28) of this chapter.
All other food categories .25 Flavoring agent, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

Code of Federal Regulations

[44 FR 19391, Apr. 3, 1979, as amended at 49 FR 5611, Feb. 14, 1984]
(a) Bacterially-derived protease enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.
(b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, 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, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 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. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

Code of Federal Regulations

[64 FR 19895, Apr. 23, 1999]
(a) Bentonite (Al2 O3 4SiO2 nH2 O, CAS Reg. No. 1302-0978-099) is principally a colloidal hydrated aluminum silicate. Bentonite contains varying quantities of iron, alkalies, and alkaline earths in the commercial products. Depending on the cations present, natural deposits of bentonite range in color from white to gray, yellow, green, or blue. Bentonite's fine particles provide large total surface area and, hence, pronounced adsorptive capability.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in § 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice results in no significant residue in foods.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

Code of Federal Regulations

[47 FR 43367, Oct. 1, 1982, as amended at 73 FR 8606, Feb. 14, 2008]
(a) Benzoyl peroxide ((C6 H5 CO)2 O2, CAS Reg. No. 94-36-0) is a colorless, rhombic crystalline solid. It is prepared by reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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 food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a bleaching agent in food.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: flour; milk used for production of Asiago fresh and Asiago soft cheese ( § 133.102 ), Asiago medium cheese ( § 133.103 ), Asiago old cheese ( § 133.104 ), Blue cheese ( § 133.106 ), Caciocavallo siciliano chesse ( § 133.111 ), Gorgonzola cheese ( § 133.141 ), Parmesan and reggiano cheese ( § 133.165 ), Provolone cheese ( § 133.181 ), Romano cheese ( § 133.183 ), and Swiss and emmentaler cheese ( § 133.195) in part 133 of this chapter; and annatto-colored whey, such that the final bleached product conforms to the descriptions and specifications for whey, concentrated whey, or dried whey in § 184.1979(a) (1), (2), or (3), respectively.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

Code of Federal Regulations

[51 FR 27173, July 30, 1986]
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