cfr_sections
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236 rows where part_number = 184 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:3.0.1.1.14.1.1.1 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | A | Subpart A—General Provisions | § 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS). | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 48 FR 48457, 48459, Oct. 19, 1983; 62 FR 15110, Mar. 31, 1997; 81 FR 55051, Aug. 17, 2016] | (a) The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and affirmed to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. The regulations in this part shall sufficiently describe each ingredient to identify the characteristics of the ingredient that has been affirmed as GRAS and to differentiate it from other possible versions of the ingredient that have not been affirmed as GRAS. Ingredients affirmed as GRAS in this part are also GRAS as indirect human food ingredients, subject to any limitations prescribed in parts 174, 175, 176, 177, 178 or § 179.45 of this chapter or in part 186 of this chapter. The purity specifications in this part do not apply when the ingredient is used in indirect applications. However, when used in indirect applications, the ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter. (b) Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. For the purpose of this part, current good manufacturing practice includes the requirements that a direct human food ingredient be of appropriate food grade; that it be prepared and handled as a food ingredient; and that the quantity of the ingredient added to food does not exceed the amount reasonably required to accomplish the intended physical, nutritional, or other technical effect in food. (1) If the ingredient is affirmed as GRAS with no limitations on its conditions of use other than current good manufacturing practice, it shall be regarded as GRAS if its conditions of use are consistent with the requirements of paragraph (b), (c), and (d) of this section. When the Food and Drug Administration (FDA) determines that it is appropriate, the agency will describe one or more current good manufacturing practice conditions of use in the regulation that affirms the GRAS status of the ingredient. For example, when the safety of an ingredie… | |||
| 21:21:3.0.1.1.14.2.1.1 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1005 Acetic acid. | FDA | [47 FR 27814, June 25, 1982] | (a) Acetic acid (C 2 H 4 O 2 , CAS Reg. No. 64-19-7) is known as ethanoic acid. It occurs naturally in plant and animal tissues. It is produced by fermentation of carbohydrates or by organic synthesis. The principal synthetic methods currently employed are oxidation of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and reaction of carbon monoxide with methanol derived from natural gas. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 8, 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) The ingredient is used as a curing and pickling agent as defined in § 170.3(o)(5) of this chapter; flavor enhancer as defined in § 170.3(o)(11) of this chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; as a solvent and vehicle as defined in § 170.3(o)(27) of this chapter; and as a boiler water additive complying with § 173.310 of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level as served, of 0.25 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.8 percent for cheeses as defined in § 170.3(n)(5) of this chapter and dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.5 percent for chewing gum as defined in § 170.3(n)(6) of this chapter; 9.0 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.5 percent for fats and oils as defined in § 170.3(n)(12) of this chapter; 3.0 percent for gravies and s… | |||
| 21:21:3.0.1.1.14.2.1.10 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1033 Citric acid. | FDA | [59 FR 63895, Dec. 12, 1994] | (a) Citric acid (C 6 H 8 O 7 , CAS Reg. No. 77-92-9) is the compound 2-hydroxy-1,2,3-propanetricarboxylic acid. It is a naturally occurring constituent of plant and animal tissues. It occurs as colorless crystals or a white powder and may be anhydrous or contain one mole of water per mole of citric acid. Citric acid may be produced by recovery from sources such as lemon or pineapple juice; by mycological fermentation using Candida spp. , described in §§ 173.160 and 173.165 of this chapter; and by the solvent extraction process described in § 173.280 of this chapter for the recovery of citric acid from Aspergillus niger fermentation liquor. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992), pp. 107-108, which are 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, and the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, 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) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.100 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1351 Gum tragacanth. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984] | (a) Gum tragacanth is the exudate from one of several species of Astragalus gummifier Labillardiere, a shrub that grows wild in mountainous regions of the Middle East. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 337, 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 under the following conditions: Maximum Usage Levels Permitted (d) [Reserved] (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.101 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1355 Helium. | FDA | [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a colorless, odorless, flavorless, nonflammable, inert gas. It is lighter than air and is produced by the liquefaction and purification of natural gas. (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 limitations 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.102 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1366 Hydrogen peroxide. | FDA | [46 FR 44439, Sept. 4, 1981, as amended at 51 FR 27172, July 30, 1986] | (a) Hydrogen peroxide (H 2 O 2 , CAS Reg. No. 7722-84-1) is also referred to as hydrogen dioxide. It is made by the electrolytic oxidation of sulfuric acid or a sulfate to persulfuric acid or a persulfuric acid salt with subsequent hydrolysis and distillation of the hydrogen peroxide formed; by decomposition of barium peroxide with sulfuric or phosphoric acid; by hydrogen reduction of 2-ethylanthraquinone, followed by oxidation with air, to regenerate the quinone and produce hydrogen peroxide; or by electrical discharge through a mixture of hydrogen, oxygen, and water vapor. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 146-147, 1 which is incorporated by reference. 1 Copies may be obtained from the National Academy of Sciences, 2101 Constitution Ave. NW, Washington, DC 20037, or 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) In accordance with § 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations: (d) Residual hydrogen peroxide is removed by appropriate physical and chemical means during the processing of food where it has been used according to paragraph (c) of this section. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.103 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1370 Inositol. | FDA | [47 FR 38278, Aug. 31, 1982] | (a) Inositol, or myo-inositol (C 6 H 12 O 6 , CAS Reg. No. 87-89-8), is cis -1,2,3,5- trans -4,6-cyclohexanehexol. It occurs naturally and is prepared from an aqueous (0.2 percent sulfur dioxide) extract of corn kernels by precipitation and hydrolysis of crude phytate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 150, 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 limitations 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in special dietary foods as defined in part 105 of this chapter at levels not to exceed current good manufacturing practice. It may also be used in infant formula in accordance with section 412(g) of the Act, or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established by this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.104 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1372 Insoluble glucose isomerase enzyme preparations. | FDA | [48 FR 5720, Feb. 8, 1983, as amended at 61 FR 43450, Aug. 23, 1996] | (a) Insoluble glucose isomerase enzyme preparations are used in the production of high fructose corn syrup described in § 184.1866. They are derived from recognized species of precisely classified nonpathogenic and nontoxicogenic microorganisms, including Streptomyces rubiginosus, Actinoplanes missouriensis, Streptomyces olivaceus, Streptomyces olivochromogenes, and Bacillus coagulans, that have been grown in a pure culture fermentation that produces no antibiotics. They are fixed (rendered insoluble) for batch production with GRAS ingredients or may be fixed for further immobilization with either GRAS ingredients or materials approved under § 173.357 of this chapter. (b) The ingredient meets the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107, 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 an enzyme, as defined in § 170.3(o)(9) of this chapter, to convert glucose to fructose. (2) The ingredient is used in high fructose corn syrup, at levels not to exceed current good manufacturing practice. | |||
| 21:21:3.0.1.1.14.2.1.105 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1375 Iron, elemental. | FDA | [53 FR 16867, May 12, 1988] | (a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron obtained by any of the following processes: reduced iron, electrolytic iron, and carbonyl iron. (1) Reduced iron is prepared by reacting ground ferric oxide with hydrogen or carbon monoxide at an elevated temperature. The process results in a grayish-black powder, all of which should pass through a 100-mesh sieve. It is lusterless or has not more than a slight luster. When viewed under a microscope, it appears as an amorphous powder free from particles having a crystalline structure. It is stable in dry air. (2) Electrolytic iron is prepared by electrodeposition. It is an amorphous, lusterless, grayish-black powder. It is stable in dry air. (3) Carbonyl iron is prepared by the decomposition of iron pentacarbonyl. It occurs as a dark gray powder. When viewed under a microscope, it appears as spheres built up with concentric shells. It is stable in dry air. (b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron, carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp. 152-153), 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 as a nutrient supplement as defined in § 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredient may also be used in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(2)). (d) Prior sanctions for this ingredient different from t… | |||
| 21:21:3.0.1.1.14.2.1.106 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1386 Isopropyl citrate. | FDA | [59 FR 63896, Dec. 12, 1994, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Isopropyl citrate is a mixture of the mono-, di-, and triisopropyl esters of citric acid. It is prepared by esterifying citric acid with isopropanol. (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 an antioxidant as defined in § 170.3(o)(3) of this chapter; a sequestrant as defined in § 170.3(o)(26) of this chapter; and a solvent and vehicle as defined in § 170.3(o)(27) of this chapter. (2) The ingredient is used in margarine in accordance with § 166.110 of this chapter; in nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; and in fats and oils as defined in § 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.107 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1387 Lactase enzyme preparation from Candida pseudotropicalis. | FDA | [61 FR 7704, Feb. 29, 1996, as amended at 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast C. pseudotropicalis. It contains the enzyme lactase (β-D-galactoside galactohydrolase, EC 3.2.1.23), which converts lactose to glucose and galactose. It is prepared from yeast that has been grown by a pure culture fermentation process. (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), pp. 107-110, which are 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human 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 convert lactose to glucose and galactose. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is limited to use of this ingredient to reduce the lactose content in milk and milk-derived food products where food standards do not preclude such use. | |||
| 21:21:3.0.1.1.14.2.1.108 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1388 Lactase enzyme preparation from Kluyveromyces lactis. | FDA | [49 FR 47387, Dec. 4, 1984] | (a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast Kluyveromyces lactis (previously named Saccharomyces lactis). It contains the enzyme β-galactoside galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose and galactose. It is prepared from yeast that has been grown in a pure culture fermentation and by using materials that are generally recognized as safe or are food additives that have been approved for this use by the Food and Drug Administration. (b) The ingredient meets the general and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p. 107-110, 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 as a direct human 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 convert lactose to glucose and galactose. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice is to use this ingredient in milk to produce lactase-treated milk, which contains less lactose than regular milk, or lactose-reduced milk, which contains at least 70 percent less lactose than regular milk. | |||
| 21:21:3.0.1.1.14.2.1.109 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1400 Lecithin. | FDA | [48 FR 51150, Nov. 7, 1983] | (a) Commercial lecithin is a naturally occurring mixture of the phosphatides of choline, ethanolamine, and inositol, with smaller amounts of other lipids. It is isolated as a gum following hydration of solvent-extracted soy, safflower, or corn oils. Lecithin is bleached, if desired, by hydrogen peroxide and benzoyl peroxide and dried by heating. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 166-167, 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.11 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1034 Catalase (bovine liver). | FDA | [60 FR 32910, June 26, 1995, as amended at 69 FR 24512, May 4, 2004; 78 FR 14666, Mar. 7, 2013] | (a) Catalase (bovine liver) (CAS Reg. No. 81457-95-6) is an enzyme preparation obtained from extracts of bovine liver. It is a partially purified liquid or powder. Its characterizing enzyme activity is catalase (EC 1.11.1.6). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, 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 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, and 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 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 decompose hydrogen peroxide. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. | |||
| 21:21:3.0.1.1.14.2.1.110 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1408 Licorice and licorice derivatives. | FDA | [50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989] | (a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza. Licorice extract is that portion of the licorice root that is, after maceration, extracted by boiling water. The extract can be further purified by filtration and by treatment with acids and ethyl alcohol. Licorice extract is sold as a liquid, paste (“block”), or spray-dried powder. (2) Ammoniated glycyrrhizin is prepared from the water extract of licorice root by acid precipitation followed by neutralization with dilute ammonia. Monoammonium glycyrrhizinate (C 42 H 61 O 16 NH 4 5H 2 O, CAS Reg. No. 1407-03-0) is prepared from ammoniated glycyrrhizin by solvent extraction and separation techniques. (b) The ingredients shall meet the following specifications when analyzed: (1) Assay. The glycyrrhizin content of each flavoring ingredient shall be determined by the method in the Official Methods of Analysis of the Association of Official Analytical Chemists, 13th Ed., §§ 19.136-19.140, which is incorporated by reference, or by methods 19.CO1 through 19.CO4 in the Journal of the Association of Official Analytical Chemists, 65:471-472 (1982), which are also incorporated by reference. Copies of all of these methods are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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) Ash. Not more than 9.5 percent for licorice, 2.5 percent for ammoniated glycyrrhizin, and 0.5 percent for monoammonium glycyrrhizinate on an anhydrous basis as determined by the method in the Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available … | |||
| 21:21:3.0.1.1.14.2.1.111 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1409 Ground limestone. | FDA | [48 FR 52442, Nov. 18, 1983] | (a) Ground limestone consists essentially (not less than 94 percent) of calcium carbonate (CaCO 3 ) and is prepared by the crushing, grinding, and classifying of naturally occurring limestone. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 173, 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.112 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1415 Animal lipase. | FDA | [60 FR 32911, June 26, 1995, as amended at 78 FR 14666, Mar. 7, 2013] | (a) Animal lipase (CAS Reg. No. 9001-62-1) is an enzyme preparation obtained from edible forestomach tissue of calves, kids, or lambs, or from animal pancreatic tissue. The enzyme preparation may be produced as a tissue preparation or as an aqueous extract. Its characterizing enzyme activity is that of a triacylglycerol hydrolase (EC 3.1.1.3). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, 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 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, and 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 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 fatty acid glycerides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. | |||
| 21:21:3.0.1.1.14.2.1.113 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1420 Lipase enzyme preparation derived from Rhizopus niveus. | FDA | [63 FR 24419, May 4, 1998, as amended at 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) Lipase enzyme preparation contains lipase enzyme (CAS Reg. No. 9001-62-1), which is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Rhizopus niveus. The enzyme preparation also contains diatomaceous earth as a carrier. The characterizing activity of the enzyme, which catalyzes the interesterification of fats and oils at the 1- and 3-positions of triglycerides, is triacylglycerol lipase (EC 3.1.1.3). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the monograph on Enzyme Preparations in the “Food Chemicals Codex,” 4th ed. (1996), pp. 133 and 134, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (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 as a direct human 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 for the interesterification of fats and oils. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. | |||
| 21:21:3.0.1.1.14.2.1.114 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1425 Magnesium carbonate. | FDA | [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985] | (a) Magnesium carbonate (molecular formula approximately (MgCO 3 ) 4 ·Mg(OH) 2 ·5H 2 O, CAS Reg. No. 39409-82-0) is also known as magnesium carbonate hydroxide. It is a white powder formed either by adding an alkaline carbonate (such as sodium carbonate) to a solution of magnesium sulfate or by carbonation of a slurry of magnesium hydroxide followed by boiling of the resulting magnesium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 177, 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 an anticaking and free-flow agent as defined in § 170.3(o)(1) of this chapter; a flour treating agent as defined in § 170.3(o)(13) of this chapter; a lubricant and release agent as defined in § 170.3(o)(18) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; and a synergist as defined in § 170.3(o)(31) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.115 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1426 Magnesium chloride. | FDA | [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985] | (a) Magnesium chloride (MgC1 2 ·6H 2 O, CAS Reg. No. 7786-30-3) is a colorless, deliquescent, crystalline material that occurs naturally as the mineral bischofite. It is prepared by dissolving magnesium oxide, hydroxide, or carbonate in aqueous hydrochloric acid solution and crystallizing out magnesium chloride hexahydrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 177, 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 flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter and a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.116 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1428 Magnesium hydroxide. | FDA | [50 FR 13559, Apr. 5, 1985, as amended at 64 FR 405, Jan. 5, 1999] | (a) Magnesium hydroxide (Mg(OH) 2 , CAS Reg. No. 1309-42-8) occurs naturally as the colorless, crystalline mineral brucite. It is prepared as a white precipitate by the addition of sodium hydroxide to a water soluble magnesium salt or by hydration of reactive grades of magnesium oxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; and a processing aid as defined in § 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.117 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1431 Magnesium oxide. | FDA | [50 FR 13559, Apr. 5, 1985] | (a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally as the colorless, crystalline mineral periclase. It is produced either as a bulky white powder (light) or a relatively dense white powder (heavy) by heating magnesium hydroxide or carbonate. Heating these magnesium salts under moderate conditions (400° to 900 °C for a few hours) produces light magnesium oxide. Heating the salts under more rigorous conditions (1200 °C for 12 hours) produces heavy magnesium oxide. Light magnesium oxide is converted to heavy magnesium oxide by sustained heating at high temperatures. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 178, 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 an anticaking and free-flow agent as defined in § 170.3(o)(1) of this chapter; a firming agent as defined in § 170.3(o)(10) of this chapter; a lubricant and release agent as defined in § 170.3(o)(18) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) of this chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at levels not be exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with… | |||
| 21:21:3.0.1.1.14.2.1.118 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1434 Magnesium phosphate. | FDA | [50 FR 13560, Apr. 5, 1985, as amended at 69 FR 24512, May 4, 2004] | (a) Magnesium phosphate includes both magnesium phosphate, dibasic, and magnesium phosphate, tribasic. Magnesium phosphate, dibasic (MgHPO 4 ·3H 2 O, CAS Reg. No. 7782-0975-094) occurs naturally as the white, crystalline mineral newberyite. It is prepared commercially as a precipitate formed by treating a solution of magnesium sulfate with disodium phosphate under controlled conditions. Magnesium phosphate, tribasic (Mg 3 (PO 4 )2·xH 2 O, CAS Reg. No. 7757-87-1) may contain 4, 5, or 8 molecules of water of hydration. It is produced as a precipitate from a solution of magnesite with phosphoric acid. (b) Magnesium phosphate, dibasic, meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 179, which is incorporated by reference. Magnesium phosphate, tribasic, meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 180, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter and a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient also may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section … | |||
| 21:21:3.0.1.1.14.2.1.119 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1440 Magnesium stearate. | FDA | [50 FR 13560, Apr. 5, 1985] | (a) Magnesium stearate (Mg(C 17 H 34 COO) 2 , CAS Reg. No. 557-04-0) is the magnesium salt of stearic acid. It is produced as a white precipitate by the addition of an aqueous solution of magnesium chloride to an aqueous solution of sodium stearate derived from stearic acid that is obtained from edible sources and that conforms to the requirements of § 172.860(b)(2) of this chapter. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 182, 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 lubricant and release agent as defined in § 170.3(o)(18) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) of this chapter; and a processing aid as defined in § 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.12 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1061 Lactic acid. | FDA | [49 FR 35367, Sept. 7, 1984] | (a) Lactic acid (C 3 H 6 O 3 , CAS Reg. Nos.: dl mixture, 598-82-3; l -isomer, 79-33-4; d -isomer, 10326-41-7), the chemical 2-hydroxypropanoic acid, occurs naturally in several foods. It is produced commercially either by fermentation of carbohydrates such as glucose, sucrose, or lactose, or by a procedure involving formation of lactonitrile from acetaldehyde and hydrogen cyanide and subsequent hydrolysis to lactic acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Avenue, 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 an antimicrobial agent as defined in § 170.3(o)(2) of this chapter; a curing and pickling agent as defined in § 170.3(o)(5) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; and a solvent and vehicle as defined in § 170.3(o)(27) of this chapter. (2) The ingredient is used in food, except in infant foods and infant formulas, at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.120 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1443 Magnesium sulfate. | FDA | [50 FR 13560, Apr. 5, 1985] | (a) Magnesium sulfate (MgSO 4 ·7H 2 O, CAS Reg. No. 10034-99-8) occurs naturally as the mineral epsomite. It is prepared by neutralization of magnesium oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solution to crystallization. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, 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 flavor enhancer as defined in § 170.3(o)(11) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) of this chapter; and a processing aid as defined in § 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.121 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1443a Malt. | FDA | [60 FR 32911, June 26, 1995] | (a) Malt is an enzyme preparation obtained from barley which has been softened by a series of steeping operations and germinated under controlled conditions. It is a brown, sweet, and viscous liquid or a white to tan powder. Its characterizing enzyme activities are α-amylase (EC 3.2.1.1.) and β-amylase (EC 3.2.1.2). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, 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 Office of Premarket Approval (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and 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 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 starch or starch-derived polysaccharides. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. | |||
| 21:21:3.0.1.1.14.2.1.122 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1444 Maltodextrin. | FDA | [48 FR 51911, Nov. 15, 1983, as amended at 60 FR 48893, Sept. 21, 1995; 63 FR 14611, Mar. 26, 1998; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) Maltodextrin ((C 6 H 10 O 5 ) n , CAS Reg. No. 9050-36-6) is a nonsweet nutritive saccharide polymer that consists of D-glucose units linked primarily by α-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is prepared as a white powder or concentrated solution by partial hydrolysis of corn starch, potato starch, or rice starch with safe and suitable acids and enzymes. (b)(1) Maltodextrin derived from corn starch must be of a purity suitable for its intended use. (2) Maltodextrin derived from potato starch meets the specifications of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p. 125, which are 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 at the Division of Petition Control (HFS-217), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 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.. (3) Maltodextrin derived from rice starch meets the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 239 and 240, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (c) In accordance with § … | |||
| 21:21:3.0.1.1.14.2.1.123 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1445 Malt syrup (malt extract). | FDA | [48 FR 51613, Nov. 10, 1983, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Malt is the product of barley ( Hordeum vulgare L.) germinated under controlled conditions. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of water extract of germinated barley grain, with or without added safe preservative. Malt syrup is usually a brown, sweet, and viscous liquid containing varying amounts of amylolytic enzymes and plant constituents. Barley is first softened after cleaning by steeping operations and then allowed to germinate under controlled conditions. The germinated grain then undergoes processing, such as drying, grinding, extracting, filtering, and evaporating, to produce malt syrup (malt extract) with 75 to 80 percent solids or dried malt syrup with higher solids content. (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 flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.124 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1446 Manganese chloride. | FDA | [50 FR 19165, May 7, 1985, as amended at 76 FR 59250, Sept. 26, 2011] | (a) Manganese chloride (MnCl 2 , CAS Reg. No. 7773-01-5) is a pink, translucent, crystalline product. It is also known as manganese dichloride. It is prepared by dissolving manganous oxide, pyrolusite ore (MnO 2 ), or reduced manganese ore in hydrochloric acid. The resulting solution is neutralized to precipitate heavy metals, filtered, concentrated, and crystallized. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.125 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1449 Manganese citrate. | FDA | [50 FR 19166, May 7, 1985, as amended at 73 FR 8607, Feb. 14, 2008; 76 FR 59250, Sept. 26, 2011] | (a) Manganese citrate (Mn 3 (C 6 H 5 O 7 ) 2 , CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. It is obtained by precipitating manganese carbonate from manganese sulfate and sodium carbonate solutions. The filtered and washed precipitate is digested first with sufficient citric acid solution to form manganous citrate and then with sodium citrate to complete the reaction. (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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(13) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk products as defined in § 170.3(n)(31) of this chapter; and poultry products as defined in § 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.126 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1452 Manganese gluconate. | FDA | [50 FR 19166, May 7, 1985] | (a) Manganese gluconate (C 12 H 22 MnO 14 ·2H 2 O, CAS Reg. No. 648-0953-0998) is a slightly pink colored powder. It is obtained by reacting manganese carbonate with gluconic acid in aqueous medium and then crystallizing the product. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n)(13) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk products as defined in § 170.3(n)(31) of this chapter; and poultry products as defined in § 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.127 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1461 Manganese sulfate. | FDA | [50 FR 19166, May 7, 1985] | (a) Manganese sulfate (MnSO 4 ·H 2 O, CAS Reg. No. 7785-0987-097) is a pale pink, granular, odorless powder. It is obtained by reacting manganese compounds with sulfuric acid. It is also obtained as a byproduct in the manufacture of hydroquinone. Other manufacturing processes include the action of sulfur dioxide on a slurry of manganese dioxide in sulfuric acid, and the roasting of pyrolusite (MnO 2 ) ore with solid ferrous sulfate and coal, followed by leaching and crystallization. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 188, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; fish products as defined in § 170.3(n(13) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk products as defined in § 170.3(n)(31) of this chapter; and poultry products as defined in § 170.3(n)(34) of this chapter. The ingredient may be used in infant formulas in accordance with section 41… | |||
| 21:21:3.0.1.1.14.2.1.128 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1472 Menhaden oil. | FDA | [62 FR 30756, June 5, 1997, as amended at 70 FR 14531, Mar. 23, 2005; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023; 88 FR 53773, Aug. 9, 2023] | (a) Menhaden oil. (1) Menhaden oil is prepared from fish of the genus Brevoortia, commonly known as menhaden, by cooking and pressing. The resulting crude oil is then refined using the following steps: Storage (winterization), degumming (optional), neutralization, bleaching, and deodorization. Winterization may separate the oil and produce a solid fraction. (2) Menhaden oil meets the following specifications: (i) Color and state. Yellow liquid to white solid. (ii) Odor. Odorless to slightly fishy. (iii) Saponification value. Between 180 and 200 as determined by the American Oil Chemists' Society Official Method Cd 3-25—“Saponification Value” (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the Office of Food Additive Safety, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (iv) Iodine number. Not less than 120 as determined by the American Oil Chemists' Society Recommended Practice Cd 1d-92—“Iodine Value of Fats and Oils, Cyclohexane—Acetic Acid Method,” which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (a)(2)(iii) of this section. (v) Unsaponifiable matter. Not more than 1.5 percent as determined by the American Oil Chemists' Society Official Method Ca 6b-53—“Unsaponifiable Matter” (reapproved 1989), which is incorporated by reference in accordance wit… | |||
| 21:21:3.0.1.1.14.2.1.129 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1490 Methylparaben. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984] | (a) Methylparaben is the chemical methyl p -hydroxybenzoate. It is produced by the methanol esterification of p -hydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 199, 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 as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food. (e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.13 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1063 Enzyme-modified lecithin. | FDA | [61 FR 45889, Aug. 30, 1996, as amended at 78 FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) Enzyme-modified lecithin is prepared by treating lecithin with either phospholipase A 2 (EC 3.1.1.4) or pancreatin. (b) The ingredient meets the specifications in paragraphs (b)(1) through (b)(8) of this section. Unless otherwise noted, compliance with the specifications listed below is determined according to the methods set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 220-221, which are 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (1) Acetone-insoluble matter (phosphatides), not less than 50.0 percent. (2) Acid value, not more than 40. (3) Lead, not more than 1.0 part per million, as determined by atomic absorption spectroscopy. (4) Heavy metals (as Pb), not more than 20 parts per million. (5) Hexane-insoluble matter, not more than 0.3 percent. (6) Peroxide value, not more than 20. (7) Water, not more than 4.0 percent. (8) Lysolecithin, 50 to 80 mole percent of total phosphatides as determined by “Determination of Lysolecithin Content of Enzyme-Modified Lecithin: Method I,” dated 1985, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 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 may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockvil… | |||
| 21:21:3.0.1.1.14.2.1.130 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1498 Microparticulated protein product. | FDA | [55 FR 6391, Feb. 23, 1990] | (a) Microparticulated protein product is prepared from egg whites or milk protein or a combination of egg whites and milk protein. These protein sources may be used alone or in combination with other safe and suitable ingredients to form the microparticulated product. The mixture of ingredients is high-shear heat processed to achieve a smooth and creamy texture similar to that of fat. Safe and suitable ingredients used in the preparation of the microparticulated protein product must be used in compliance with the limitations of the appropriate regulations in parts 172, 182, and 184 of this chapter. (b) The ingredient is used in food in accordance with § 184.1(b)(2) at levels not to exceed current good manufacturing practice. The affirmation of the use of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following conditions of use: (1) The ingredient is used in food as a thickener as defined in § 170.3(o)(28) of this chapter or as a texturizer as defined in § 170.3(o)(32) of this chapter. (2) The ingredient is used in frozen dessert-type products except that the ingredient may not be used to replace the milk fat required in standardized frozen desserts. (3) The name of the ingredient used in the ingredient statement on both bulk and packaged food must include the source of the protein (e.g., “microparticulated egg white protein”), followed by a parenthetical listing of each of the ingredients in the microparticulated protein product, in descending order of predominance. Microparticulated protein product must be used in accordance with this requirement or its addition to food will be considered by FDA to constitute the use of an unapproved food additive (see § 184.1(b)(2)). | |||
| 21:21:3.0.1.1.14.2.1.131 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1505 Mono- and diglycerides. | FDA | [54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar. 27, 1992] | (a) Mono- and diglycerides consist of a mixture of glyceryl mono- and diesters, and minor amounts of triesters, that are prepared from fats or oils or fat-forming acids that are derived from edible sources. The most prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by the reaction of glycerin with fatty acids or the reaction of glycerin with triglycerides in the presence of an alkaline catalyst. The products are further purified to obtain a mixture of glycerides, free fatty acids, and free glycerin that contains at least 90 percent-by-weight glycerides. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in accordance with 5 U.S.C. 552(a). 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 in food as a dough strengthener as defined in § 170.3(o)(6) of this chapter; an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter; a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; a formulation aid as defined in § 170.3(o)(14) of this chapter; a lubricant and release agent as defined in § 170.3(o)(18) of this chapter; a solvent and vehicle as defined in § 170.3(o)(27) of this chapter; a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter;… | |||
| 21:21:3.0.1.1.14.2.1.132 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1521 Monosodium phosphate derivatives of mono- and diglycerides. | FDA | [54 FR 7404, Feb. 21, 1989, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Monosodium phosphate derivatives of mono- and diglycerides are composed of glyceride derivatives formed by reacting mono- and diglycerides that are derived from edible sources with phosphorus pentoxide (tetraphosphorus decoxide) followed by neutralization with sodium carbonate. (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 in food as an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter, a lubricant and release agent as defined in § 170.3(o)(18) of this chapter, and as a surface-active agent as defined in § 170.3(o)(29) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: dairy product analogs as defined in § 170.3(n)(10) of this chapter and soft candy as defined in § 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.133 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1530 Niacin. | FDA | [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983, as amended at 64 FR 1760, Jan. 12, 1999; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) Niacin (C 6 H 5 NO 2 , CAS Reg. No. 59-67-6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It is a non-hygroscopic, stable, white, crystalline solid that sublimes without decomposition at about 230 °C. It is soluble in water and alcohol. It is insoluble in ether. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), p. 264, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (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 direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.134 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1535 Niacinamide. | FDA | [48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983] | (a) Niacinamide (C 6 H 6 N 2 O, CAS Reg. No. 98-92-0) is the chemical 3-pyridinecarboxylic acid amide (nicotinamide). It is a white crystalline powder that is soluble in water, alcohol, ether, and glycerol. It melts between 128° and 131 °C. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 205, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.135 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1537 Nickel. | FDA | [48 FR 51618, Nov. 10, 1983, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from nickel ore by transforming it to nickel sulfide (Ni 3 S 2 ). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is then reduced with carbon to give elemental nickel. (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 catalyst as defined in § 170.3(o)(24) of this chapter. (2) The ingredient is used in the hydrogenation of fats and oils as defined in § 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. Current good manufacturing practice includes the removal of nickel from fats and oils following hydrogenation. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.136 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1538 Nisin preparation. | FDA | [53 FR 11250, Apr. 6, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003; 88 FR 17724, Mar. 24, 2023] | (a) Nisin preparation is derived from pure culture fermentations of certain strains of Streptococcus lactis Lancefield Group N. Nisin preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related peptides with antibiotic activity. (b) The ingredient is a concentrate or dry material that meets the specifications that follow when it is tested as described in “Specifications for Identity and Purity of Some Antibiotics,” World Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969, which is incorporated by reference. Copies are available from the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (1) Nisin content, not less than 900 international units per milligram. (2) Arsenic, not more than 1 part per million. (3) Lead, not more than 2 parts per million. (4) Zinc, not more than 25 parts per million. (5) Copper, zinc plus copper not more than 50 parts per million. (6) Total plate count, not more than 10 per gram. (7) Escherichia coli, absent in 10 grams. (8) Salmonella, absent in 10 grams. (9) Coagulase positive staphylococci, absent in 10 grams. (c) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter to inhibit the outgrowth of Clostridium botulinum spores and toxin formation in pasteurized cheese spreads and pasteurized process cheese spreads listed in § 133.175; pasteurized cheese spread with fruits, vegetables, or meats as defined in § 133.176; pasteurized process cheese spread as defined in § 133.179; pasteurized process cheese spread with fruits, vegetables, or meats as defined in § 133.180 of this chapter. (d) The ingredient is used … | |||
| 21:21:3.0.1.1.14.2.1.137 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1540 Nitrogen. | FDA | [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Nitrogen (empirical formula N 2 , CAS Reg. No. 7727-37-9) is a colorless, odorless, flavorless gas that is produced commercially by the fractionation of liquid air. (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 limitations 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 propellant, aerating agent, and gas as defined in § 170.3(o)(25) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.138 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1545 Nitrous oxide. | FDA | [48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008] | (a) Nitrous oxide (empirical formula N 2 O, CAS Reg. No. 10024-97-2) is also known as dinitrogen monoxide or laughing gas. It is a colorless gas, about 50 percent heavier than air, with a slightly sweet smell. It does not burn but will support combustion. Nitrous oxide is manufactured by the thermal decomposition of ammonium nitrate. Higher oxides of nitrogen are removed by passing the dry gas through a series of scrubbing towers. (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 limitations 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 propellant, aerating agent, and gas as defined in § 170.3(o)(25) of this chapter. (2) The ingredient is used in dairy product analogs as defined in § 170.3(n)(10) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.139 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1553 Peptones. | FDA | [49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, 2008] | (a) Peptones are a variable mixture of polypeptides, oligopeptides, and amino acids that are produced by partial hydrolysis of casein, animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg albumin, or lactalbumin (whey protein). Peptones are produced from these proteins using proteolytic enzymes that either are considered to be generally recognized as safe (GRAS) or are regulated as food additives. Peptones are also produced by denaturing any of the proteins listed in this paragraph with safe and suitable acids or heat. (b) The ingredients must be of a purity suitable for their intended use. (c) In accordance with § 184.1(b)(1), these ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as GRAS as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) These ingredients are used as nutrient supplements as defined in § 170.3(o)(20) of this chapter; as processing aids as defined in § 170.3(o)(24) of this chapter; and as surface-active agents as defined in § 170.3(o)(29) of this chapter. (2) These ingredients are used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.14 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1065 Linoleic acid. | FDA | [49 FR 48534, Dec. 13, 1984, as amended at 73 FR 8606, Feb. 14, 2008] | (a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid (C 17 H 31 COOH) (CAS Reg. No. 60-33-3)), a straight chain unsaturated fatty acid with a molecular weight of 280.5, is a colorless oil at room temperature. Linoleic acid may be prepared from edible fats and oils by various methods including hydrolysis and saponification, the Twitchell method, low pressure splitting with catalyst, continuous high pressure counter current splitting, and medium pressure autoclave splitting with catalyst. (b) The ingredient must be of a purity suitable for its intended use. The ingredient must also meet the specifications in § 172.860(b) of this chapter. (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 flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter and as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.140 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1555 Rapeseed oil. | FDA | [42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 50 FR 3755, Jan. 28, 1985; 53 FR 52682, Dec. 29, 1988; 73 FR 8608, Feb. 14, 2008; 88 FR 53773, Aug. 9, 2023] | (a) Fully hydrogenated rapeseed oil. (1) Fully hydrogenated rapeseed oil is a mixture of triglycerides in which the fatty acid composition is a mixture of saturated fatty acids. The fatty acids are present in the same proportions which result from the full hydrogenation of fatty acids occurring in natural rapeseed oil. The rapeseed oil is obtained from the napus and campestris varieties of Brassica of the family Cruciferae. It is prepared by fully hydrogenating refined and bleached rapeseed oil at 310-375 °F, using a catalyst such as nickel, until the iodine number is 4 or less. (2) The ingredient meets the following specifications: Acid value not more than 6, arsenic not more than 3 parts per million, free glycerin not more than 7 percent, heavy metals (as Pb) not more than 10 parts per million, iodine number not more than 4, residue on ignition not more than 0.5 percent. (3) The ingredient is used as a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter in peanut butter. The use level of the ingredient is limited by good manufacturing practice (GMP) to the minimum amount required to produce the intended effect. Current good manufacturing practices result in a maximum level of 2 percent in peanut butter. (b) Superglycerinated fully hydrogenated rapeseed oil. (1) Superglycerinated fully hydrogenated rapeseed oil is a mixture of mono- and diglycerides with triglycerides as a minor component. The fatty acid composition is a mixture of saturated fatty acids present in the same proportions as those resulting from the full hydrogenation of fatty acids in natural rapeseed oil. It is made by adding excess glycerol to the fully hydrogenated rapeseed oil and heating, in the presence of a sodium hydroxide catalyst, to 330 °F under partial vacuum and steam sparging agitation. (2) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 201, relating to mono- and diglycerides, which is incorporated by reference. Copies may be obtained from the National Academy P… | |||
| 21:21:3.0.1.1.14.2.1.141 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1560 Ox bile extract. | FDA | [43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985] | (a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified oxgall or sodium choleate, is a yellowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. It is the purified portion of the bile of an ox obtained by evaporating the alcohol extract of concentrated bile. (b) Food-grade ox bile extract shall meet the specifications of the U.S. Pharmacopeia (USP), XIV, 1950, p. 410. 1 1 Copies may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852. (c) The ingredient is used as a surfactant as defined in § 170.3 (o)(29) of this chapter. (d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.002 percent for cheese as defined in § 170.3(n)(5) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.142 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1563 Ozone. | FDA | [47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995] | (a) Ozone (O 3 , CAS Reg. No. 10028-15-6) is an unstable blue gas with a pungent, characteristic odor, which occurs freely in nature, It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter. (c) In accordance with § 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations: | |||
| 21:21:3.0.1.1.14.2.1.143 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1583 Pancreatin. | FDA | [60 FR 32911, June 26, 1995, as amended at 78 FR 14666, Mar. 7, 2013] | (a) Pancreatin (CAS Reg. No. 8049-47-6) is an enzyme preparation obtained from porcine or bovine pancreatic tissue. It is a white to tan powder. Its characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36). (b) The ingredient meets the general requirements and additional requirements in the Food Chemicals Codex, 3d ed. (1981), p. 110, 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 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, and 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 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. | |||
| 21:21:3.0.1.1.14.2.1.144 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1585 Papain. | FDA | [48 FR 48806, Oct. 21, 1983] | (a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived from Carica papaya L. Crude latex containing the enzyme is collected from slashed unripe papaya. The food-grade product is obtained by repeated filtration of the crude latex or an aqueous solution of latex or by precipitation from an aqueous solution of latex. The resulting enzyme preparation may be used in a liquid or dry form. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 107-110, 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 conditions of use: (1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter; processing aid as defined in § 170.3(o)(24) of this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.145 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1588 Pectins. | FDA | [48 FR 51149, Nov. 7, 1983] | (a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex, high molecular weight polysaccharides found in plants and composed chiefly of partially methylated polygalacturonic acid units. Portions of the carboxly group occur as methyl esters, and the remaining carboxyl groups exist in the form of the free acid or as its ammonium, potassium, or sodium (CAS Reg. No. 9000-59-8) salts, and in some types as the acid amide. Thus, the pectins regulated in this section are the high-ester pectins, low-ester pectins, amidated pectins, pectinic acids, and pectinates. Pectin is produced commercially by extracting citrus peel, apple pomace, or beet pulp with hot dilute acid (pH 1.0 to 3.5, 70° to 90 °C). The extract is filtered, and pectin is then precipitated from the clear extract with ethanol or isopropanol, or as the copper or aluminum salt. The acid extract is sometimes spray- or roller-dried, or it is concentrated to be sold as liquid pectin. (b) The ingredients meet the specifications of the Food Chemical Codex, 3d Ed. (1981), p. 215, 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 ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as generally recognized as safe (GRAS) as direct human food ingredients is based upon the following current good manufacturing practice conditions of use: (1) The ingredients are used as emulsifiers as defined in § 170.3(o)(8) of this chapter and as stabilizers and thickeners as defined in § 170.3(o)(28) of this chapter. (2) The ingredients are used in food at levels not to exceed current good manufacturing… | |||
| 21:21:3.0.1.1.14.2.1.146 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1595 Pepsin. | FDA | [60 FR 32911, June 26, 1995, as amended at 78 FR 14667, Mar. 7, 2013] | (a) Pepsin (CAS Reg. No. 9001-75-6) is an enzyme preparation obtained from the glandular layer of hog stomach. It is a white to light tan powder, amber paste, or clear amber to brown liquid. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.23.1). (b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, 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 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, and 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 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. | |||
| 21:21:3.0.1.1.14.2.1.147 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1610 Potassium alginate. | FDA | [47 FR 29951, July 9, 1982] | (a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Potassium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, 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)(2), the ingredient is used in food only within the following specific limitations: (d) Prior sanctions for potassium alginate different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.148 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1613 Potassium bicarbonate. | FDA | [48 FR 52442, Nov. 18, 1983] | (a) Potassium bicarbonate (KHCO 3 , CAS Reg. No. 298-14-6) is made by the following processes: (1) By treating a solution of potassium hydroxide with carbon dioxide; (2) By treating a solution of potassium carbonate with carbon dioxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, 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 formulation aid as defined in § 170.3(o)(14) of this chapter; nutrient supplement as defined in § 170.3(o)(20) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; and 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.149 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1619 Potassium carbonate. | FDA | [48 FR 52442, Nov. 18, 1983] | (a) Potassium carbonate (K 2 CO 3 , CAS Reg. No. 584-08-7) is produced by the following methods of manufacture: (1) By electrolysis of potassium chloride followed by exposing the resultant potassium to carbon dioxide; (2) By treating a solution of potassium hydroxide with excess carbon dioxide to produce potassium carbonate; (3) By treating a solution of potassium hydroxide with carbon dioxide to produce potassium bicarbonate, which is then heated to yield potassium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 240, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, D.C. 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 in food as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; nutrient supplement as defined in § 170.3(o)(20) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; and 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.15 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1069 Malic acid. | FDA | [44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984] | (a) Malic acid (C 4 H 6 O 5 , CAS Reg. No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic acid, occurs naturally in various foods. Racemic DL-malic acid does not occur naturally. It is made commercially by hydration of fumaric acid or maleic acid. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 183-184, 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 ingredients are used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, and pH control agent as defined in § 170.3(o)(23) of this chapter. (d) The ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 3.4 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in § 170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; 6.9 percent for hard candy as defined in § 170.3(n)(25) of this chapter; 2.6 percent for jams and jellies as defined in § 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as defined in § 170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in § 170.3(n)(38) of this chapter; and 0.7 percent for all other food categories. (e) Prior sanctions for malic acid different from the uses established in this section do not exist or … | |||
| 21:21:3.0.1.1.14.2.1.150 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1622 Potassium chloride. | FDA | [48 FR 51614, Nov. 10, 1983] | (a) Potassium chloride (KCl, CAS Reg. No. 7447-40-7) is a white, odorless solid prepared from source minerals by fractional crystallization or flotation. It is soluble in water and glycerol and has a saline taste at low concentration levels. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 241, 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 flavor enhancer as defined in § 170.3(o)(11) of this chapter; as a flavoring agent as defined in § 170.3(o)(12) of this chapter; as a nutrient supplement as defined in § 170.3(o)(20) of this chapter; as a pH control agent as defined in § 170.3(o)(23) of this chapter; and as a stabilizer or thickener as defined in § 170.3(o)(28) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Potassium chloride may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.151 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1625 Potassium citrate. | FDA | [59 FR 63896, Dec. 12, 1994] | (a) Potassium citrate (C 6 H 5 K 3 O 7 ·H 2 O, CAS Reg. No. 006100-0905-096) is the potassium salt of citric acid. It is prepared by neutralizing citric acid with potassium hydroxide or potassium carbonate. It occurs as transparent crystals or a white granular powder, is odorless and deliquescent, and contains one mole of water per mole of potassium citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), p. 242, 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, and the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, 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) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.152 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1631 Potassium hydroxide. | FDA | [48 FR 52444, Nov. 18, 1983] | (a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known as caustic potash, potash lye, and potassa. The empirical formula is KOH. It is a white, highly deliquescent caustic solid, which is marketed in several forms, including pellets, flakes, sticks, lumps, and powders. Potassium hydroxide is obtained commercially from the electrolysis of potassium chloride solution in the presence of a porous diaphragm. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available from 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 formulation aid as defined in § 170.3(o)(14) of this chapter; a pH control agent as defined in § 170.3(o)(23) of the chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; and a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.153 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1634 Potassium iodide. | FDA | [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984; 61 FR 14247, Apr. 1, 1996] | (a) Potassium iodide (KI, CAS Reg. No. 7681-11-0) is the potassium salt of hydriodic acid. It occurs naturally in sea water and in salt deposits, but can be prepared by reacting hydriodic acid (HI) with potassium bicarbonate (KHCO 3 ). (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 246-247, 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 as a nutrient supplement as defined in § 170.3(o)(20) of this chapter. (d) The ingredient is used in table salt in accordance with § 184.1(b)(2) of this chapter as a source of dietary iodine at a maximum level of 0.01 percent. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.154 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1635 Potassium iodate. | FDA | [43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984] | (a) Potassium iodate (KIO 3 , CAS Reg. No. 7758-05-6) does not occur naturally but can be prepared by reacting iodine with potassium hydroxide. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 245-246, 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 as a dough strengthener as defined in § 170.3(o)(6) of this chapter. (d) The ingredient is used in the manufacture of bread in accordance with § 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 percent based on the weight of the flour. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.155 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1639 Potassium lactate. | FDA | [52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Potassium lactate (C 3 H 5 O 3 K, CAS Reg. No. 996-31-6) is the potassium salt of lactic acid. It is a hydroscopic, white, odorless solid and is prepared commercially by the neutralization of lactic acid with potassium hydroxide. (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. This regulation does not authorize its use in infant foods and infant formulas. 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 flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.156 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1643 Potassium sulfate. | FDA | [45 FR 6086, Jan. 25, 1980, as amended at 49 FR 5613, Feb. 14, 1984] | (a) Potassium sulfate (K 2 SO 4 , CAS Reg. No. 7778-80-5) occurs naturally and consists of colorless or white crystals or crystalline powder having a bitter, saline taste. It is prepared by the neutralization of sulfuric acid with potassium hydroxide or potassium carbonate. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 252, 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 as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.015 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.157 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1655 Propane. | FDA | [48 FR 57271, Dec. 29, 1983, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Propane (empirical formula C 3 H 8 , CAS Reg. No. 74-98-6) is also known as dimethylmethane or propyl hydrid. It is a colorless, odorless, flammable gas at normal temperatures and pressures. It is easily liquefied under pressure at room temperature and is stored and shipped in the liquid state. Propane is obtained from natural gas by fractionation following absorption in oil, adsorption to surface-active agents, or refrigeration. (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 limitations 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 propellant, aerating agent, and gas as defined in § 170.3(o)(25) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.158 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1660 Propyl gallate. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11, 1979; 49 FR 5613, Feb. 14, 1984] | (a) Propyl gallate is the n -propylester of 3,4,5-trihydroxybenzoic acid (C 10 H 12 O 5 ). Natural occurrence of propyl gallate has not been reported. It is commercially prepared by esterification of gallic acid with propyl alcohol followed by distillation to remove excess alcohol. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 257-258, 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 as an antioxidant as defined in § 170.3(o)(3) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Good manufacturing practice results in a maximum total content of antioxidants of 0.02 percent of the fat or oil content, including the essential (volatile) oil content, of the food. (e) Prior sanctions for this ingredient different from the uses established in this section, or different from that stated in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.159 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1666 Propylene glycol. | FDA | [47 FR 27812, June 25, 1982] | (a) Propylene glycol (C 3 H 8 O 2 , CAS Reg. No. 57-55-6) is known as 1,2-propanediol. It does not occur in nature. Propylene glycol is manufactured by treating propylene with chlorinated water to form the chlorohydrin which is converted to the glycol by treatment with sodium carbonate solution. It is also prepared by heating glycerol with sodium hydroxide. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 255, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418. It is also 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) The ingredient is used as an anticaking agent as defined in § 170.3(o)(1) of this chapter; antioxidant as defined in § 170.3(o)(3) of this chapter; dough strengthener as defined in § 170.3(o)(6) of this chapter; emulsifier as defined in § 170.3(o)(8) of this chapter; flavor agent as defined in § 170.3(o)(12) of this chapter; formulation aid as defined in § 170.3(o)(14) of this chapter; humectant as defined in § 170.3(o)(16) of this chapter; processing aid as defined in § 170.3(o)(24) of this chapter; solvent and vehicle as defined in § 170.3(o)(27) of this chapter; stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; surface-active agent as defined in § 170.3(o)(29) of this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter. (d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 5 percent for alcoholic beverages, as defined in § 170.3(n)(2) of this chapter; 24 percent for confections and frostings as defined in § 170.3(n)(9) of this chapter; 2.5 percent for frozen… | |||
| 21:21:3.0.1.1.14.2.1.16 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1077 Potassium acid tartrate. | FDA | [48 FR 52446, Nov. 18, 1983] | (a) Potassium acid tartrate (C 4 H 5 KO 6 , CAS Reg. No. 868-14-4) is the potassium acid salt of l−(+)−tartaric acid and is also called potassium bitartrate or cream of tartar. It occurs as colorless or slightly opaque crystals or as a white, crystalline powder. It has a pleasant, acid taste. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), P. 238, 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 an anticaking agent as defined in § 170.3(o)(1) of this chapter; an antimicrobial agent as defined in § 170.3(o)(2) of this chapter; a formulation aid as defined in § 170.3(o)(14) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; A pH control agent as defined in § 170.3(o)(23) of this chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and a surface-active agent as defined in § 170.3(o)(29) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; confections and frostings as defined in § 170.3(n)(9) of this chapter; gelat… | |||
| 21:21:3.0.1.1.14.2.1.160 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1670 Propylparaben. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] | (a) Propylparaben is the chemical propyl p -hydroxybenzoate. It is produced by the n -propanol esterification of p -hydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 258, 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 as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food. (e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.161 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1676 Pyridoxine hydrochloride. | FDA | [48 FR 51615, Nov. 10, 1983] | (a) Pyridoxine hydrochloride (C 8 H 11 NO 3 ·HCl, CAS Reg. No. 58-56-0) is the chemical 3-hydroxy-4,5-dihydroxymethy-2-methylpyridine hydrochloride that is prepared by chemical synthesis. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 260, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases as defined in § 170.3(n)(3) of this chapter; breakfast cereals as defined in § 170.3(n)(4) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; milk products as defined in § 170.3(n)(31) of this chapter; plant protein products as defined in § 170.3(n)(33) of this chapter; and snack foods as defined in § 170.3(n)(37) of this chapter. Pyridoxine hydrochloride may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established i… | |||
| 21:21:3.0.1.1.14.2.1.162 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived). | FDA | [55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992; 58 FR 27202, May 7, 1993] | (a)(1) Rennet and bovine rennet are commercial extracts containing the active enzyme rennin (CAS Reg. No. 9001-98-3), also known as chymosin (International Union of Biochemistry Enzyme Commission (E.C.) 3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen, salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs. Bovine rennet is the product from adults of the animals listed above. Both products are called rennet and are clear amber to dark brown liquid preparations or white to tan powders. (2) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Escherichia coli K-12 containing the prochymosin gene. The prochymosin is isolated as an insoluble aggregate that is acid-treated to destroy residual cellular material and, after solubilization, is acid-treated to form chymosin. It must be processed with materials that are generally recognized as safe, or are food additives that have been approved by the Food and Drug Administration for this use. (3) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety lactis, containing the prochymosin gene. The prochymosin is secreted by cells into fermentation broth and converted to chymosin by acid treatment. All materials used in the processing and formulating of chymosin must be either generally recognized as safe (GRAS), or be food additives that have been approved by the Food and Drug Administration for this use. (4) Chymosin preparation is a clear solution containing the active enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a nonpathogenic and nontoxigenic strain of Aspergillus niger van Tieghem variety awamori (Nakazawa) Al-Musallam (synonym A. awamori Nakazawa) containing the prochymosin gene. Chymosin is recovered from the fermentati… | |||
| 21:21:3.0.1.1.14.2.1.163 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1695 Riboflavin. | FDA | [48 FR 51148, Nov. 7, 1983] | (a) Riboflavin (C 17 H 20 N 4 O 6 , CAS Reg. No. 83-88-5) occurs as yellow to orange-yellow needles that are crystallized from 2 N acetic acid, alcohol, water, or pyridine. It may be prepared by chemical synthesis, biosynthetically by the organism Eremothecium ashbyii, or isolated from natural sources. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 262, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.164 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1697 Riboflavin-5′-phosphate (sodium). | FDA | [48 FR 51148, Nov. 7, 1983] | (a) Riboflavin-5′-phosphate (sodium) (C 17 H 20 N 4 O 9 PNa·2H 2 O, CAS Reg. No 130-40-5) occurs as the dihydrate in yellow to orange-yellow crystals. It is prepared by phosphorylation of riboflavin with chlorophosphoric acid, pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic phosphate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 263, 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 nutrient supplement as defined in § 170.3(o)(20) of this chapter. (2) The ingredient is used in milk products, as defined in § 170.3(n)(31) of this chapter, at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formulas in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the Act) or with regulations promulgated under section 412(a)(2) of the Act. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.165 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1698 Rue. | FDA | [43 FR 3705, Jan. 27, 1978] | (a) Rue is the perennial herb of several species of Ruta ( Ruta montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis L.). The leaves, buds, and stems from the top of the plant are gathered, dried, and then crushed in preparation for use, or left whole. (b) The ingredient is used in all categories of food in accordance with § 184.1(b)(2) of this chapter at concentrations not to exceed 2 parts per million. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.166 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1699 Oil of rue. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984; 64 FR 1760, Jan. 12, 1999; 81 FR 5596, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023] | (a) Oil of rue is the natural substance obtained by steam distillation of the fresh blossoming plants of rue, the perennial herb of several species of Ruta—Ruta montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis L. (b) Oil of rue meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), pp. 342-343, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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. (c) The ingredient is used in food under the following conditions: Maximum Usage Levels Permitted (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.167 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1702 Sheanut oil. | FDA | [63 FR 28895, May 27, 1998] | (a) Sheanut oil is produced from sheanuts derived from the Shea tree Butyrospermum parkii and is composed principally of triglycerides containing an oleic acid moiety at the 2-position and saturated fatty acids, usually stearic or palmitic acids, at the 1- and 3-positions. (b) The ingredient meets the following specifications when tested using any appropriate validated methodology: (1) Saponification value of 185 to 195, (2) Iodine value of 28 to 43, (3) Unsaponifiable matter not to exceed 1.5 percent, (4) Free fatty acids not more than 0.1 percent as oleic acid, (5) Peroxide value not more than 10 milliequivalents/equivalent (meq/eq), (6) Lead not more than 0.1 part per million (ppm), (7) Copper not more than 0.1 ppm. (c) In accordance with § 184.1(b)(3), the ingredient is used in the following food categories at levels not to exceed current good manufacturing practice, except that the ingredient may not be used in a standardized food unless permitted by the standard of identity: 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. | |||
| 21:21:3.0.1.1.14.2.1.168 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1721 Sodium acetate. | FDA | [47 FR 27815, June 25, 1982] | (a) Sodium acetate (C 2 H 3 O 2 Na, CAS Reg. No. 127-09-3 or C 2 H 3 O 2 Na·3H 2 O, CAS Reg. No. 6131-90-4) is the sodium salt of acetic acid and occurs naturally in plant and animal tissues. Sodium acetate may occur in either the anhydrous or trihydrated form. It is produced synthetically by the neutralization of acetic acid with sodium carbonate or by treating calcium acetate with sodium sulfate and sodium bicarbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 272, 273 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) The ingredient is used as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; and as a pH control agent as defined in § 170.3(o)(23) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.007 percent for breakfast cereals as defined in § 170.3(n)(4) of this chapter; 0.5 percent for fats and oils as defined in § 170.3(n)(12) of this chapter; 0.6 percent for grain products and pastas as defined in § 170.3(n)(23) of this chapter and snack foods as defined in § 170.3(n)(37) of this chapter; 0.15 percent for hard candy as defined in § 170.3(n)(25) of this chapter; 0.12 percent for jams and jellies as defined in § 170.3(n)(28) of this chapter and meat products as defined in § 170.3(n)(29) of this chapter; 0.2 percent for soft candy as defined in § 170.3(n)(38) of this chapter; 0.05 percent for soups and soup mixes as defined in § 170.3(n)(40) of this chapter and sweet sauces as defined in § 170.3(n)(43) o… | |||
| 21:21:3.0.1.1.14.2.1.169 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1724 Sodium alginate. | FDA | [47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983] | (a) Sodium alginate (CAS Reg. No. 9005-38-3) is the sodium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Sodium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 274, 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)(2), the ingredient is used in food only within the following specific limitations: (d) Prior sanctions for sodium alginate different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.17 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1081 Propionic acid. | FDA | [49 FR 13141, Apr. 3, 1984] | (a) Propionic acid (C 3 H 6 O 2 , CAS Reg. No. 79-09-4) is an oily liquid having a slightly pungent, rancid odor. It is manufactured by chemical synthesis or by bacterial fermentation. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 254, 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 an antimicrobial agent as defined in § 170.3(o)(2) of this chapter and a flavoring agent as defined in § 170.3(o)(12) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.170 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1733 Sodium benzoate. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] | (a) Sodium benzoate is the chemical benzoate of soda (C 7 H 5 NaO 2 ), produced by the neutralization of benzoic acid with sodium bicarbonate, sodium carbonate, or sodium hydroxide. The salt is not found to occur naturally. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 278, 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 as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practice. Current usage results in a maximum level of 0.1 percent in food. (The Food and Drug Administration has not determined whether significally different conditions of use would be GRAS.) (e) Prior sanctions for this ingredient different from the uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.171 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1736 Sodium bicarbonate. | FDA | [48 FR 52442, Nov. 18, 1983] | (a) Sodium bicarbonate (NaHCO 3 , CAS Reg. No. 144-55-8) is prepared by treating a sodium carbonate or a sodium carbonate and sodium bicarbonate solution with carbon dioxide. As carbon dioxide is absorbed, a suspension of sodium bicarbonate forms. The slurry is filtered, forming a cake which is washed and dried. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 278, 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.172 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1742 Sodium carbonate. | FDA | [48 FR 52442, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985] | (a) Sodium carbonate (Na 2 CO 3 , CAS Reg. No. 497-19-8) is produced (1) from purified trona ore that has been calcined to soda ash; (2) from trona ore calcined to impure soda ash and then purified; or (3) synthesized from limestone by the Solvay process. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 280, 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 in food as an antioxidant as defined in § 170.3(o)(3) of this chapter; curing and pickling agent as defined in § 170.3(o)(5) of this chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; and 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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.173 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1751 Sodium citrate. | FDA | [59 FR 63896, Dec. 12, 1994] | (a) Sodium citrate (C 6 H 5 Na 3 O 7 ·2H 2 O, CAS Reg. No. 68-0904-092) is the sodium salt of citric acid. It is prepared by neutralizing citric acid with sodium hydroxide or sodium carbonate. The product occurs as colorless crystals or a white crystalline powder. It may be prepared in an anhydrous state or may contain two moles of water per mole of sodium citrate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 283-284, 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, and the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, 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) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.174 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1754 Sodium diacetate. | FDA | [47 FR 27815, June 25, 1982] | (a) Sodium diacetate (C 4 H 7 O 4 Na·xH 2 O, CAS Reg. No. 126-96-5) is a molecular compound of acetic acid, sodium acetate, and water of hydration. The technical grade is prepared synthetically by reacting sodium carbonate with acetic acid. Special grades are produced by reacting anhydrous sodium acetate and acetic acid. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 284, 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) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; and pH control agent as defined in § 170.3(o)(23) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, 0.4 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.1 percent for fats and oils as defined in § 170.3(n)(12) of this chapter, meat products as defined in § 170.3(n)(29) of this chapter and soft candy as defined in § 170.3(n)(38) of this chapter; 0.25 percent for gravies and sauces as defined in § 170.3(n)(24) of this chapter; and 0.05 percent for snack foods as defined in § 170.3(n)(37) of this chapter and soups and soup mixes as defined in § 170.3(n)(40) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.175 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1763 Sodium hydroxide. | FDA | [48 FR 52444, Nov. 18, 1983] | (a) Sodium hydroxide (NaOH, CAS Reg. No. 1310-73-2) is also known as sodium hydrate, soda lye, caustic soda, white caustic, and lye. The empirical formula is NaOH. Sodium hydroxide is prepared commercially by the electrolysis of sodium chloride solution and also by reacting calcium hydroxide with sodium carbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), 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 pH control agent as defined in § 170.3(o)(23) of this chapter and as a processing aid as defined in § 170.3(o)(24) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.176 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1764 Sodium hypophosphite. | FDA | [47 FR 38277, Aug. 31, 1982, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Sodium hypophosphite (NaH 2 PO 2 , CAS Reg. No. 7681-53-0) is a white, odorless, deliquescent granular powder with a saline taste. It is also prepared as colorless, pearly crystalline plates. It is soluble in water, alcohol, and glycerol. It is prepared by neutralization of hypophosphorous acid or by direct aqueous alkaline hydrolysis of white phosphorus. (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 limitations 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 an emulsifier or stabilizer, as defined in §§ 170.3(o)(8) and 170.3(o)(28) of this chapter. (2) The ingredient is used in cod-liver oil emulsions at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.177 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1768 Sodium lactate. | FDA | [52 FR 10886, Apr. 6, 1987, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Sodium lactate (C 3 H 5 O 3 N a , CAS Reg. No. 72-17-3) is the sodium salt of lactic acid. It is prepared commercially by the neutralization of lactic acid with sodium hydroxide. (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. This regulation does not authorize its use in infant foods and infant formulas. 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 an emulsifier as defined in § 170.3(o)(8) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined in § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.178 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1769a Sodium metasilicate. | FDA | [50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985, as amended at 72 FR 10357, Mar. 8, 2007; 73 FR 8608, Feb. 14, 2008] | (a) Sodium metasilicate (CAS Reg. No. 6834-92-0) is a strongly alkaline white powder. It does not occur naturally but rather is synthesized by melting sand with sodium carbonate at 1400 °C. The commercially available forms of sodium metasilicate are the anhydrous form (Na 2 SiO 3 ), the pentahydrate (Na 2 SiO 3 ·5H 2 O), and the nonahydrate (Na 2 SiO 3 ·9H 2 O). (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 to treat the following foods at levels not to exceed current good manufacturing practice: for use in washing and lye peeling of fruits, vegetables, and nuts when used in accordance with § 173.315 of this chapter; for use as a denuding agent in tripe; for use as a hog scald agent in removing hair; and for use as a corrosion preventative in canned and bottled water when used in accordance with § 165.110 of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.179 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1784 Sodium propionate. | FDA | [49 FR 13142, Apr. 3, 1984] | (a) Sodium propionate (C 3 H 5 NaO 2 , CAS Reg. No. 137-40-6) is the sodium salt of propionic acid. It occurs as colorless, transparent crystals or a granular crystalline powder. It is odorless, or has a faint acetic-butyric acid odor, and is deliquescent. It is prepared by neutralizing propionic acid with sodium hydroxide. (b) The ingredients meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 296, 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 an antimicrobial agent as defined in § 170.3(o)(2) of this chapter and a flavoring agent as defined in § 170.3(o)(12) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; cheeses as defined in § 170.3(n)(5) of this chapter; confections and frostings as defined in § 170.3(n)(9) of this chapter; gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; jams and jellies as defined in § 170.3(n)(28) of this chapter; meat products as defined in § 170.3(n)(29) of this chapter; and soft candy as defined in § 170.3(n)(38) of this chapter. (d) Prior sanctions for this ingredient different from the uses established in this section do no… | |||
| 21:21:3.0.1.1.14.2.1.18 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1090 Stearic acid. | FDA | [48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985; 69 FR 24512, May 4, 2004] | (a) Stearic acid (C 18 H 36 O 2 , CAS Reg. No. 57-11-4) is a white to yellowish white solid. It occurs naturally as a glyceride in tallow and other animal or vegetable fats and oils and is a principal constituent of most commercially hydrogenated fats. It is produced commercially from hydrolyzed tallow derived from edible sources or from hydrolyzed, completely hydrogenated vegetable oil derived from edible sources. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and the requirements of § 172.860(b)(2) of this chapter. Copies of the Food Chemicals Codex 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 flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. (2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.180 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1792 Sodium sesquicarbonate. | FDA | [48 FR 52443, Nov. 18, 1983] | (a) Sodium sesquicarbonate (Na 2 CO 3 ·NaHCO 3 ·2H 2 O, CAS Reg. No. 533-96-0) is prepared by: (1) Partial carbonation of soda ash solution followed by crystallization, centrifugation, and drying; (2) double refining of trona ore, a naturally occurring impure sodium sesquicarbonate. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 299, 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 pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in cream at levels not to exceed current good manufacturing practice. Current good manufacturing practice utilizes a level of the ingredient sufficient to control lactic acid prior to pasteurization and churning of cream into butter. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.181 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1801 Sodium tartrate. | FDA | [48 FR 52447, Nov. 18, 1983] | (a) Sodium tartrate (C 4 H 4 Na 2 O 6 ·2H 2 O, CAS Reg. No. 868-18-8) is the disodium salt of l−(+)−tartaric acid. It occurs as transparent, colorless, and odorless crystals. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 303, 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 an emulsifier as defined in § 170.3(o)(8) of this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: cheeses as defined in§ 170.3(n)(5) of this chapter; fats and oils as defined in § 170.3(n)(12) of this chapter; and jams and jellies as defined in § 170.3(n)(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. | |||
| 21:21:3.0.1.1.14.2.1.182 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1804 Sodium potassium tartrate. | FDA | [48 FR 52447, Nov. 18, 1983] | (a) Sodium potassium tartrate (C 4 H 4 KNaO 6 ·4H 2 O, CAS Reg. No. 304-59-6) is the sodium potassium salt of l−(+)−tartaric acid and is also called the Rochelle salt. It occurs as colorless crystals or as a white, crystalline powder and has a cooling saline taste. It is obtained as a byproduct of wine manufacture. (b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 296, 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 an emulsifier as defined in § 170.3(o)(8) of this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter. (2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: cheeses as defined in § 170.3(n)(5) of this chapter and jams and jellies as defined in § 170.3(n)(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. | |||
| 21:21:3.0.1.1.14.2.1.183 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1807 Sodium thiosulfate. | FDA | [43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984] | (a) Sodium thiosulfate (Na 2 S 2 O 3 ·5H 2 O, CAS Reg. No. 010102-0917-097) is also known as sodium hyposulfite. It is prepared synthetically by the reaction of sulfides and sulfur dioxide (SO 2 ), the reaction of sulfur and sulfite, or the oxidation of metal sulfides and hydrosulfides. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 304, 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 as a formulation aid as defined in § 170.3(o)(14) of this chapter and reducing agent as defined in § 170.3(o)(22) of this chapter. (d) The ingredient is used in alcoholic beverages and table salt in accordance with § 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.00005 percent for alcoholic beverages as defined in § 170.3(n)(2) of this chapter and 0.1 percent for table salt as defined in § 170.3(n)(26) of this chapter. (e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.184 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1835 Sorbitol. | FDA | [42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984] | (a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol (C 6 H 14 O 6 ), a hexahydric alcohol, differing from mannitol principally by having a different optical rotation. Sorbitol is produced by the electrolytic reduction, or the transition metal catalytic hydrogenation of sugar solutions containing glucose or fructose. (b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 308, 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 as an anticaking agent and free-flow agent as defined in § 170.3(o)(1) of this chapter, curing and pickling agent as defined in § 170.3(o)(5) of this chapter, drying agent as defined in § 170.3(o)(7) of this chapter, emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter, firming agent as defined in § 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, formulation aid as defined in § 170.3(o)(14) of this chapter, humectant as defined in § 170.3(o)(16) of this chapter, lubricant and release agent as defined in § 170.3(o)(18) of this chapter, nutritive sweetener as defined in § 170.3(o)(21) of this chapter, sequestrant as defined in § 170.3(o)(26) of this chapter, stabilizer and thickener as defined in § 170.3(o)(28) of this chapter, surface-finishing agent as defined in § 170.3(o)(30) of this chapter, and texturizer as defined in § 170.3(o)(32) of this chapter. (d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice in the use of sorbitol results in a maximum level of 99 percent in hard candy and cough drops as defined in § 170.3(n)(25) of th… | |||
| 21:21:3.0.1.1.14.2.1.185 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1845 Stannous chloride (anhydrous and dihydrated). | FDA | [47 FR 27816, June 25, 1982, as amended at 76 FR 59250, Sept. 26, 2011] | (a) Stannous chloride is anhydrous or contains two molecules of water of hydration. Anhydrous stannous chloride (SnCl 2 , CAS Reg. No. 7772-99-8) is the chloride salt of metallic tin. It is prepared by reacting molten tin with either chlorine or gaseous tin tetrachloride. Dihydrated stannous chloride (SnCl 2 ·2H 2 O, CAS Reg. No. 10025-69-1) is the chloride salt of metallic tin that contains two molecules of water. It is prepared from granulated tin suspended in water and hydrochloric acid or chlorine. (b) Both forms of the ingredient meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 312, 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) The ingredient is used as an antioxidant as defined in § 170.3(o)(3) of this chapter. (d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with § 184.(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.0015 percent or less; calculated as tin, for all food categories. (e) Prior sanctions for this ingredient different from those uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.186 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1848 Starter distillate. | FDA | [48 FR 51907, Nov. 15, 1983, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Starter distillate (butter starter distillate) is a steam distillate of the culture of any or all of the following species of bacteria grown on a medium consisting of skim milk usually fortified with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris, S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L. dextranicum. The ingredient contains more than 98 percent water, and the remainder is a mixture of butterlike flavor compounds. Diacetyl is the major flavor component, constituting as much as 80 to 90 percent of the mixture of organic flavor compounds. Besides diacetyl, starter distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin. (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 flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter. (2) The ingredient is used in food at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.187 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1851 Stearyl citrate. | FDA | [59 FR 63897, Dec. 12, 1994, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Stearyl citrate is a mixture of the mono-, di-, and tristearyl esters of citric acid. It is prepared by esterifying citric acid with stearyl alcohol. (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 an antioxidant as defined in § 170.3(o)(3) of this chapter; an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter; a sequestrant as defined in § 170.3(o)(26) of this chapter; and a surface-active agent as defined in § 170.3(o)(29) of this chapter. (2) The ingredient is used in margarine in accordance with § 166.110 of this chapter; in nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; and in fats and oils as defined in § 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. (d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived. | |||
| 21:21:3.0.1.1.14.2.1.188 | 21 | Food and Drugs | I | B | 184 | PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE | B | Subpart B—Listing of Specific Substances Affirmed as GRAS | § 184.1854 Sucrose. | FDA | [53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989, as amended at 73 FR 8608, Feb. 14, 2008] | (a) Sucrose (C 12 H 22 O 11 , CAS Reg. No. 57-50-11-1) sugar, cane sugar, or beet sugar is the chemical β-D-fructofuranosyl-α-D-glucopyranoside. Sucrose is obtained by crystallization from sugar cane or sugar beet juice that has been extracted by pressing or diffusion, then clarified and evaporated. (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. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived. |
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