Title 21—Food and Drugs--Volume 1
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
§ 184.1   Substances added directly to human food affirmed as generally recognized as safe (GRAS).
(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 ingredient has been evaluated on the basis of limited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the ingredient, one or more of these limited conditions of use, which may include the category of food(s), the technical effect(s) or functional use(s) of the ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, that use of the ingredient may not be GRAS. 

In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall have a basis to conclude that that use is GRAS or shall use the ingredient in accordance with a food additive regulation.
(2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food only within such limitation(s), including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use. Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation.
(3) If the ingredient is affirmed as GRAS for a specific use, without a general evaluation of use of the ingredient, other uses may also be GRAS.
(c) The listing of a food ingredient in this part does not authorize the use of such substance in a manner that may lead to deception of the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act).
(d) The listing of more than one ingredient to produce the same technological effect does not authorize use of a combination of two or more ingredients to accomplish the same technological effect in any one food at a combined level greater than the highest level permitted for one of the ingredients.
(e) If the Commissioner of Food and Drugs is aware of any prior sanction for use of an ingredient under conditions different from those proposed to be affirmed as GRAS, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.
(f) The label and labeling of the ingredient and any intermediate mix of the ingredient for use in finished food shall bear, in addition to the other labeling required by the Act:
(1) The name of the ingredient, except where exempted from such labeling in part 101 of this chapter.
(2) A statement of concentration of the ingredient in any intermediate mix; or other information to permit a food processor independently to determine that use of the ingredients will be in accordance with any limitations and good manufacturing practice guidelines prescribed.
(3) Adequate directions for use to provide a final food product that complies with any limitations prescribed for the ingredient(s).
§ 184.1005   Acetic acid.
(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 sauces as defined in § 170.3(n)(24) of this chapter; 0.6 percent for meat products as defined in § 170.3(n)(29) of this chapter; and 0.15 percent or less for all other food categories. The ingredient may also be used in boiler water additives at levels not to exceed current good manufacturing practice.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1007   Aconitic acid.
(a) Aconitic acid (1,2,3-propenetricarboxylic acid (C 6 H 6 O 6 ), CAS Reg. No. 000499-12-7) occurs in the leaves and tubers of Aconitum napellus L. and other Ranunculaceae. Transaconitic acid can be isolated during sugarcane processing, by precipitation as the calcium salt from cane sugar or molasses. It may be synthesized by sulfuric acid dehydration of citric acid, but not by the methanesulfonic acid method.
(b) The ingredient meets the following specifications:
(1) Assay. Not less than 98.0 percent of C 3 H 3 (COOH) 3 , using the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, test for citric acid, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and a molecular weight of 174.11. Copies of the material incorporated by reference 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 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.
(2) Melting point. Not less than 195 °C and the determination results in decomposition of aconitic acid.
(3) Heavy metals ( as Pb ). Not more than 10 parts per million.
(4) Arsenic ( as As ). Not more than 3 parts per million.
(5) Oxalate. Passes test.
(6) Readily carbonizable substances. Passes the test for citric acid of the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, 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 (b)(1) of this section.
(7) Residue on ignition. Not more than 0.1 percent as determined by the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, test for citric acid, 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 (b)(1) of this section.
(c) The ingredient is used as a flavoring substance and adjuvant as defined in § 170.3(o)(12) 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 0.003 percent for baked goods as defined in § 170.3(n)(1) of this chapter, 0.002 percent for alcoholic beverages as defined in § 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy products as defined in § 170.3(n)(20) of this chapter, 0.0035 percent for soft candy as defined in § 170.3(n)(38) of this chapter, and 0.0005 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1009   Adipic acid.
(a) Adipic acid (C 6 H 10 O 4 , CAS Reg. No. 00124-04-9) is also known as 1,4-butanedicarboxylic acid or hexane-dioic acid. It is prepared by nitric acid oxidation of cyclohexanol or cyclohexanone or a mixture of the two.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 11, 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. ), and the following additional specifications:
(1) The adipic acid is converted to its corresponding amide. The amide is purified by recrystallization from water or aqueous ethanol. The melting range of the amide is 219° to 220 °C.
(2) The adipic acid is converted to its corresponding bis-p-p- bromophenacyl ester. The ester is purified by recrystallization from ethanol. The melting range of the ester is 153° to 154 °C.
(c) The ingredient is used as a flavoring agent as defined in § 170.3(o)(12) of this chapter; leavening agent as defined in § 170.3(o)(17) of this chapter; and pH control agent as defined in § 170.3(o)(23) 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 0.05 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.005 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; 5.0 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.45 percent for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.3 percent for fats and oil as defined in § 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined in § 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings as defined in § 170.3(n)(22) of this chapter; 0.1 percent for gravies as defined in § 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in § 170.3(n)(29) of this chapter; 1.3 percent for snack foods as defined in § 170.3(n)(37) of this chapter; and 0.02 percent or less for all other food categories.
(e) Prior sanctions for adipic acid different from the uses established in this section do not exist or have been waived.
§ 184.1011   Alginic acid.
(a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained from certain brown algae by alkaline extraction.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 13, 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 this ingredient different from the use established in this section do not exist or have been waived.
§ 184.1012   α-Amylase enzyme preparation from Bacillus stearothermophilus.
(a) α-Amylase enzyme preparation is obtained from the culture filtrate that results from a pure culture fermentation of a nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus. Its characterizing enzyme activity is α-amylase (1,4 α-D glucan glucanohydrolase (E.C. 3.2.1.1)).
(b) The ingredient meets the general and additional requirements for enzyme preparations in the “Food Chemicals Codex,” 3d ed. (1981), pp. 107-110, 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 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 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 practices. The affirmation of this ingredient as 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, in the hydrolysis of edible starch to produce maltodextrins and nutritive carbohydrate sweeteners.
(2) The ingredient is used at levels not to exceed current good manufacturing practices.
§ 184.1021   Benzoic acid.
(a) Benzoic acid is the chemical benzenecarboxylic acid (C 7 H 6 O 2 ), occurring in nature in free and combined forms. Among the foods in which benzoic acid occurs naturally are cranberries, prunes, plums, cinnamon, ripe cloves, and most berries. Benzoic acid is manufactured by treating molten phthalic anhydride with steam in the presence of a zinc oxide catalyst, by the hydrolysis of benzotrichloride, or by the oxidation of toluene with nitric acid or sodium bichromate or with air in the presence of a transition metal salt catalyst.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 35, 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 significantly different conditions of use would be GRAS).
(e) Prior sanctions for this ingredient different from those uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived.
§ 184.1024   Bromelain.
(a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation derived from the pineapples Ananas comosus and A. bracteatus L. It is a white to light tan amorphous powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.32).
(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, or may be examined at 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.
§ 184.1025   Caprylic acid.
(a) Caprylic acid [CH 3 (CH 2 ) 6 COOH, CAS Reg. No. 124-07-2] is the chemical name for octanoic acid. It is considered to be a short or medium chain fatty acid. It occurs normally in various foods and is commercially prepared by oxidation of n -octanol or by fermentation and fractional distillation of the volatile fatty acids present in coconut oil.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 207, 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 foods in accordance with § 184.1(b)(1), at levels not to exceed good manufacturing practice. Current good manufacturing practices result in maximum levels, as served, of: 0.013 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.04 percent for cheeses as defined in § 170.3(n)(5) of this chapter; 0.005 percent for fats and oils as defined in § 170.3(n)(12) of this chapter, for frozen dairy desserts as defined in § 170.3(n)(20) of this chapter, for gelatins and puddings as defined in § 170.3(n)(22) of this chapter, for meat products as defined in § 170.3(n)(29) of this chapter, and for soft candy as defined in § 170.3(n)(38) of this chapter; 0.016 percent for snack foods as defined in § 170.3(n)(37) of this chapter; and 0.001 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1027   Mixed carbohydrase and protease enzyme product.
(a) Mixed carbohydrase and protease enzyme product is an enzyme preparation that includes carbohydrase and protease activity. It is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic strain of B. licheniformis.
(b) The ingredient meets the specifications of 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 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 hydrolyze proteins or carbohydrates.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: alcoholic beverages, as defined in § 170.3(n)(2) of this chapter, candy, nutritive sweeteners, and protein hydrolyzates.
§ 184.1033   Citric acid.
(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.
§ 184.1034   Catalase (bovine liver).
(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.
§ 184.1061   Lactic acid.
(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.
§ 184.1063   Enzyme-modified lecithin.
(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, 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 emulsifier as defined in § 170.3(o)(8) of this chapter.
(2) The ingredient is used at levels not to exceed current good manufacturing practice.
§ 184.1065   Linoleic acid.
(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.
§ 184.1069   Malic acid.
(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 have been waived.
§ 184.1077   Potassium acid tartrate.
(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; gelatins and puddings as defined in § 170.3(n)(22) of this chapter; hard candy as defined in § 170.3(n)(25) of this chapter; jams and jellies as defined in § 170.3(n)(28) 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.
§ 184.1081   Propionic acid.
(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.
§ 184.1090   Stearic acid.
(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.
§ 184.1091   Succinic acid.
(a) Succinic acid (C 4 H 6 O 4 , CAS Reg. No. 110-15-6), also referred to as amber acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic acid. It is commercially prepared by hydrogenation of maleic or fumaric acid. It can also be produced by aqueous alkali or acid hydrolysis of succinonitrile.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 314-315, 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 flavor enhancer as defined in § 170.3(o)(11) 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 good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.084 percent in condiments and relishes as defined in § 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in § 170.3(n)(29) of this chapter.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1095   Sulfuric acid.
(a) Sulfuric acid (H 2 SO 4 , CAS Reg. No. 7664-93-9), also known as oil of vitriol, is a clear, colorless, oily liquid. It is prepared by reacting sulfur dioxide (SO 2 ) with oxygen and mixing the resultant sulfur trioxide (SO 3 ) with water, or by reacting nitric oxide (NO) with sulfur dioxide and water.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 317-318, 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 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.
(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 0.014 percent for alcoholic beverages as defined in § 170.3(n)(2) of this chapter and 0.0003 percent for cheeses 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.
§ 184.1097   Tannic acid.
(a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable gallotannin, is a complex polyphenolic organic structure that yields gallic acid and either glucose or quinic acid as hydrolysis products. It is a yellowish-white to light brown substance in the form of an amorphous, bulky powder, glistening scales, or spongy masses. It is also ordorless, or has a faint characteristic odor, and has an astringent taste. Tannic acid is obtained by solvent extraction of nutgalls or excrescences that form on the young twigs of Quercus infectoria Oliver and related species of Quercus. Tannic acid is also obtained by solvent extraction of the seed pods of Tara ( Caesalpinia spinosa ) or the nutgalls of various sumac species, including Rhus semialata, R. coriaria, R. galabra, and R. typhia.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 319, 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)(1) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:
(2) Tannic acid may be used in rendered animal fat in accordance with 9 CFR 424.21.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1099   Tartaric acid.
(a) Food grade tartaric acid (C 4 H 6 O 6 , CAS Reg. No. 87-69-4) has the l configuration. The l form of tartaric acid is dextrorotatory in solution and is also known as l−(+)−tartaric acid. Tartaric acid occurs as colorless or translucent crystals or as a white, crystalline powder. It is odorless and has an 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. 320, 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 firming agent as defined in § 170.3(o)(10) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent 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 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.
§ 184.1101   Diacetyl tartaric acid esters of mono- and diglycerides.
(a) Diacetyl tartaric acid esters of mono- and diglycerides, also known as DATEM, are composed of mixed esters of glycerin in which one or more of the hydroxyl groups of glycerin has been esterified by diacetyl tartaric acid and by fatty acids. The ingredient is prepared by the reaction of diacetyl tartaric anhydride with mono- and diglycerides that are derived from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in accordance with 5 U.S.C. 552(a). 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 in food as an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter and a flavoring agent and adjuvant 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 and baking mixes as defined in § 170.3(n)(l) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; confections and frostings as defined in § 170.3(n)(9) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; and fats and oils as defined in § 170.3(n)(12) of this chapter.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
(e) Labeling: The acronym “DATEM” may be used on food labeling as the alternate common or usual name for the ingredient diacetyl tartaric acid esters of mono- and diglycerides.
§ 184.1115   Agar-agar.
(a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic, colloidal polysaccharide extracted from one of a number of related species of red algae (class Rhodophyceae ).
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 11, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c) The ingredient is used in food in accordance with § 184.1(b)(2) under the following conditions:
Maximum Usage Levels Permitted
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1120   Brown algae.
(a) Brown algae are seaweeds of the species Analipus japonicus, Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria ochotensis, Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia, Scytosiphon lomentaria and Undaria pinnatifida. They are harvested principally in coastal waters of the northern Atlantic and Pacific oceans. The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, 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 this ingredient different from the use established in this section do not exist or have been waived.
§ 184.1121   Red algae.
(a) Red algae are seaweeds of the species Gloiopeltis furcata, Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and Rhodymenia are harvested principally along the coasts of Japan, Korea, China, Taiwan, and the East and West coasts of the United States. Gloiopeltis is harvested principally in southern Pacific coastal waters. The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference, except that the loss on drying is not more than 20 percent and the maximum allowable level for iodine is 0.05 percent. 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 this ingredient different from the use established in this section do not exist or have been waived.
§ 184.1133   Ammonium alginate.
(a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Ammonium 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. 18, 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 ammonium alginate different from the uses established in this section do not exist or have been waived.
§ 184.1135   Ammonium bicarbonate.
(a) Ammonium bicarbonate (NH 4 HCO 3 , CAS Reg. No. 1066-33-7) is prepared by reacting gaseous carbon dioxide with aqueous ammonia. Crystals of ammonium bicarbonate are precipitated from solution and subsequently washed and dried.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, 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 dough strengthener as defined in § 170.3(o)(6) 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; and a 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.
§ 184.1137   Ammonium carbonate.
(a) Ammonium carbonate ((NH 4 ) 2 CO 3 , CAS Reg. No. 8000-73-5) is a mixture of ammonium bicarbonate (NH 4 HCO 3 ) and ammonium carbamate (NH 2 COONH 4 ). It is prepared by the sublimation of a mixture of ammonium sulfate and calcium carbonate and occurs as a white powder or a hard, white or translucent mass.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, 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 leavening agent as defined in § 170.3(o)(17) 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.
§ 184.1138   Ammonium chloride.
(a) Ammonium chloride (NH 4 Cl, CAS Reg. No. 12125-02-9) is produced by the reaction of sodium chloride and an ammonium salt in solution. The less soluble sodium salt separates out at elevated temperatures, and ammonium chloride is recovered from the filtrate on cooling. Alternatively, hydrogen chloride formed by the burning of hydrogen in chlorine is dissolved in water and then reacted with gaseous ammonia. Ammonium chloride is crystallized from the solution.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, 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 dough strengthener as defined in § 170.3(o)(6) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; and a processing aid as defined in § 107.3(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.
§ 184.1139   Ammonium hydroxide.
(a) Ammonium hydroxide (NH 4 OH, CAS Reg. No. 1336-21-6) is produced by passing ammonia gas into water.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, 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 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 surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler water additive complying with § 173.310 of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. The ingredient may also be used as a boiler water additive 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.
§ 184.1140   Ammonium citrate, dibasic.
(a) Ammonium citrate, dibasic ((NH 4 ) 2 HC 6 H 5 O 7 , CAS Reg. No. 3012-65-5) is the diammonium salt of citric acid. It is prepared by partially neutralizing citric acid with ammonia.
(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 flavor enhancer as defined in § 170.3(o)(11) 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 nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter and in cheeses as defined in § 170.3(n)(5) 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.
§ 184.1141a   Ammonium phosphate, monobasic.
(a) Ammonium phosphate, monobasic (NH 4 H 2 PO 4 , CAS Reg. No. 7722-76-1) is manufactured by reacting ammonia with phosphoric acid at a pH below 5.8.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, 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 dough strengthener as defined in § 170.3(o)(6) 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.
§ 184.1141b   Ammonium phosphate, dibasic.
(a) Ammonium phosphate, dibasic ((NH 4 ) 2 HPO 4 , CAS Reg. No. 7783-28-0) is manufactured by reacting ammonia with phosphoric acid at a pH above 5.8.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, 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 dough strengthener as defined in § 170.3(o)(6) of this chapter; a firming agent as defined in § 170.3(o)(10) 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; and 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.
§ 184.1143   Ammonium sulfate.
(a) Ammonium sulfate ((NH 4 ) 2 SO 4 , CAS Reg. No. 7783-20-2) occurs naturally and consists of colorless or white, odorless crystals or granules. It is prepared by the neutralization of sulfuric acid with ammonium hydroxide.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 22-23, 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, firming agent as defined in § 170.3(o)(10) of this chapter, and processing aid as defined in § 170.3(o)(24) 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 0.15 percent for baked goods as defined in § 170.3(n)(1) of this chapter and 0.1 percent for gelatins and puddings as defined in § 170.3(n)(22) of this chapter.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1148   Bacterially-derived carbohydrase enzyme preparation.
(a) Bacterially-derived carbohydrase enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes α-amylase (EC 3.2.1.1) and β-glucanase (EC 3.2.1.6), which catalyze the hydrolysis of O -glycosyl bonds in carbohydrates.
(b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the 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. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze polysaccharides (e.g., starch).
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
§ 184.1150   Bacterially-derived protease enzyme preparation.
(a) Bacterially-derived protease enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.
(b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the 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. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
§ 184.1155   Bentonite.
(a) Bentonite (Al 2 O 3 4SiO 2 nH 2 O, CAS Reg. No. 1302-78-9) is principally a colloidal hydrated aluminum silicate. Bentonite contains varying quantities of iron, alkalies, and alkaline earths in the commercial products. Depending on the cations present, natural deposits of bentonite range in color from white to gray, yellow, green, or blue. Bentonite's fine particles provide large total surface area and, hence, pronounced adsorptive capability.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in § 170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice results in no significant residue in foods.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1157   Benzoyl peroxide.
(a) Benzoyl peroxide ((C 6 H 5 CO) 2 O 2 , CAS Reg. No. 94-36-0) is a colorless, rhombic crystalline solid. It is prepared by reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a bleaching agent in food.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: flour; milk used for production of Asiago fresh and Asiago soft cheese (§ 133.102), Asiago medium cheese (§ 133.103), Asiago old cheese (§ 133.104), Blue cheese (§ 133.106), Caciocavallo siciliano chesse (§ 133.111), Gorgonzola cheese (§ 133.141), Parmesan and reggiano cheese (§ 133.165), Provolone cheese (§ 133.181), Romano cheese (§ 133.183), and Swiss and emmentaler cheese (§ 133.195) in part 133 of this chapter; and annatto-colored whey, such that the final bleached product conforms to the descriptions and specifications for whey, concentrated whey, or dried whey in § 184.1979(a)(1), (2), or (3), respectively.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1165   n-Butane and iso-butane.
(a) n-Butane and iso-butane (empirical formula C 4 H 10 , CAS Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, flammable gases at normal temperatures and pressures. They are easily liquefied under pressure at room temperature and are stored and shipped in the liquid state. The butanes are obtained from natural gas by fractionation following absorption in oil, adsorption to surface-active agents, or refrigeration.
(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 limitations 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 propellants, aerating agents, and gases as defined in § 170.3(o)(25) of this chapter.
(2) The 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.
§ 184.1185   Calcium acetate.
(a) Calcium acetate (Ca (C 2 H 3 O 2 ) 2 , CAS Reg. No. 62-54-4), also known as acetate of lime or vinegar salts, is the calcium salt of acetic acid. It may be produced by the calcium hydroxide neutralization of acetic acid.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 44, 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 firming agent as defined in § 170.3(o)(10) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) 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; and texturizer as defined in § 170.3(o)(32) of this chapter.
(d) The ingredient is used in food at levels not to exceed current good manufacturing practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.2 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.02 percent for cheese as defined in § 170.3(n)(5) of this chapter; 0.2 percent for gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; 0.15 percent for sweet sauces, toppings, and syrups as defined in § 170.3(n)(43) of this chapter; and 0.0001 percent for all other food categories.
(e) Prior sanctions for this ingredient different from the uses established in this section or in part 181 of this chapter do not exist or have been waived.
§ 184.1187   Calcium alginate.
(a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Calcium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents, or from sodium alginate by metathesis with appropriate calcium salts.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 45, 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 calcium alginate different from the uses established in this section do not exist or have been waived.
§ 184.1191   Calcium carbonate.
(a) Calcium carbonate (CaCO 3 , CAS Reg. No. 471-34-1) is prepared by three common methods of manufacture:
(1) As a byproduct in the “Lime soda process”;
(2) By precipitation of calcium carbonate from calcium hydroxide in the “Carbonation process”; or
(3) By precipitation of calcium carbonate from calcium chloride in the “Calcium chloride process”.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 46, 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, or different from that set forth in part 181 of this chapter, do not exist or have been waived.
§ 184.1193   Calcium chloride.
(a) Calcium chloride (CaCl 2 ·2H 2 O, CAS Reg. No. 10035-04-8) or anhydrous calcium chloride (CaCl 2 , CAS Reg. No. 10043-52-4) may be commercially obtained as a byproduct in the ammonia-soda (Solvay) process and as a joint product from natural salt brines, or it may be prepared by substitution reactions with other calcium and chloride salts.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 47, 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 anticaking agent as defined in § 170.3(o)(1) of this chapter; antimicrobial agent as defined in § 170.3(o)(2) of this chapter; curing or pickling agent as defined in § 170.3(o)(5) of this chapter; firming agent as defined in § 170.3(o)(10) of this chapter; flavor enhancer as defined in § 170.3(o)(11) of this chapter; humectant as defined in § 170.3(o)(16) 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; processing aid as defined in § 170.3(o)(24) 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; synergist as defined in § 170.3(o)(31) 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 practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.3 percent for baked goods as defined in § 170.3(n)(1) of this chapter and for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.22 percent for nonalcoholic beverages and beverage bases as defined in § 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in § 170.3(n)(5) of this chapter and for processed fruit and fruit juices as defined in § 170.3(n)(35) of this chapter; 0.32 percent for coffee and tea as defined in § 170.3(n)(7) of this chapter; 0.4 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.2 percent for gravies and sauces as defined in § 170.3(n)(24) of this chapter; 0.1 percent for commercial jams and jellies as defined in § 170.3(n)(28) of this chapter; 0.25 percent for meat products as defined in § 170.3(n)(29) of this chapter; 2.0 percent for plant protein products as defined in § 170.3(n)(33) of this chapter; 0.4 percent for processed vegetables and vegetable juices as defined in § 170.3(n)(36) of this chapter; and 0.05 percent for all other food categories.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1195   Calcium citrate.
(a) Calcium citrate (Ca 3 (C 6 H 5 O 7 ) 2 ·4H 2 O, CAS Reg. No. 813-0994-095) is the calcium salt of citric acid. It is prepared by neutralizing citric acid with calcium hydroxide or calcium carbonate. It occurs as a fine white, odorless powder and usually contains four moles of water per mole of calcium citrate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 49 and 50, 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. Calcium citrate 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.
§ 184.1199   Calcium gluconate.
(a) Calcium gluconate ([CH 2 OH(CHOH) 4 COO] 2 Ca, CAS Reg. No. 299-28-5) is the calcium salt of gluconic acid which may be produced by neutralization of gluconic acid with lime or calcium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 51, 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 firming agent as defined in § 170.3(o)(10) of this chapter; formulation aid as defined in § 170.3(o)(14) of this chapter; sequestrant as defined in § 170.3(o)(26) of this chapter; stabilizer or thickener as defined in § 170.3(o)(28) 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 practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 1.75 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.4 percent for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 4.5 percent for gelatins and puddings as defined in § 170.3(n)(22) of this chapter; and 0.01 percent for sugar substitutes as defined in § 170.3(n)(42) of this chapter.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1201   Calcium glycerophosphate.
(a) Calcium glycerophosphate (C 3 H 7 CaO 6 P, CAS Reg. No. 27214-00-2) is a fine, white, odorless, almost tasteless, slightly hygroscopic powder. It is prepared by neutralizing glycerophosphoric acid with calcium hydroxide or calcium carbonate. The commercial product is a mixture of calcium β-, and D-, and L -α-glycerophosphate.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 51-52, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 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) 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 gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter.
(d) Prior sanctions for this ingredient different from the uses established in this section or different from that as set forth in part 181 of this chapter, do not exist or have been waived.
§ 184.1205   Calcium hydroxide.
(a) Calcium hydroxide (Ca(OH) 2 , CAS Reg. No. 1305-62-0) is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 52, 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.
§ 184.1206   Calcium iodate.
(a) Calcium iodate [Ca(IO 3 ) 2 ·H 2 O, CAS Reg. No. 7789-80-2], also referred to as lautarite, does not occur naturally but can be prepared by passing chlorine into a hot solution of lime (CaCO 3 ) in which iodine has been dissolved.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 53, 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.
§ 184.1207   Calcium lactate.
(a) Calcium lactate (C 6 H 10 CaO 6 . xH 2 O, where x is any integer up to 5, CAS Reg. No. 814-80-2) is prepared commercially by the neutralization of lactic acid with calcium carbonate or calcium hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 53, 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 a firming agent as defined in § 170.3(o)(10) 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 leavening agent as defined in § 170.3(o)(17) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) 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, 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.
§ 184.1210   Calcium oxide.
(a) Calcium oxide (CaO, CAS Reg. No. 1305-78-8) is also known as lime, quick lime, burnt lime, or calx. It is produced from calcium carbonate, limestone, or oyster shells by calcination at temperatures of 1,700-2,450 °F.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 55, 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.
§ 184.1212   Calcium pantothenate.
(a) Calcium pantothenate ((C 9 H 16 NO 5 ) 2 Ca, CAS Reg. No. of the D- isomer, 137-08-6) is a salt of pantothenic acid, one of the vitamins of the B complex. Only the D- isomer of pantothenic acid has vitamin activity, although both the D- isomer and the DL- racemic mixture of calcium pantothenate are used in food. Commercial calcium pantothenate is prepared synthetically from isobutyraldehyde and formaldehyde via 1,1-dimethyl-2-hydroxy-propionaldehyde and pantolactone.
(b) Calcium pantothenate meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 56, 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. Calcium pantothenate 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.
§ 184.1221   Calcium propionate.
(a) Calcium propionate (C 6 H 10 CaO 4 , CAS Reg. No. 4075-81-4) is the calcium salt of propionic acid. It occurs as white crystals or a crystalline solid, possessing not more than a faint odor of propionic acid. It is prepared by neutralizing propionic acid with calcium hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 60, 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.
(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; 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; 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.
§ 184.1229   Calcium stearate.
(a) Calcium stearate (Ca(C 17 H 35 COO) 2 , CAS Reg. No. 1529-23-0) is the calcium salt of stearic acid derived from edible sources. It is prepared as a white precipitate by mixing calcium chloride and sodium stearate in aqueous solution.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 64, 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; a lubricant and release agent as defined in § 170.3(o)(18) of this chapter; and a stabilizer and thickener as defined in § 170.3(o)(28) 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.
§ 184.1230   Calcium sulfate.
(a) Calcium sulfate (CaSO 4 , CAS Reg. No. 7778-18-9 or CaSO 4 ·2H 2 O, CAS Reg. No. 10101-41-4), also known as plaster of Paris, anhydrite, and gypsum, occurs naturally and exists as a fine, white to slightly yellow-white odorless powder. The anhydrous form is prepared by complete dehydration of gypsum, below 300 °C, in an electric oven.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 66, 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 as defined in § 170.3(o)(1) of this chapter, color and coloring adjunct as defined in § 170.3(o)(4) of this chapter, dough strengthener as defined in § 170.3(o)(6) of this chapter, drying agent as defined in § 170.3(o)(7) of this chapter, firming agent as defined in § 170.3(o)(10) of this chapter, flour treating agent as defined in § 170.3(o)(13) of this chapter, formulation aid as defined in § 170.3(o)(14) of this chapter, leavening agent as defined in § 170.3(o)(17) 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, processing aid as defined in § 170.3(o)(24) of this chapter, stabilizer and thickener as defined in § 170.3(o)(28) of this chapter, synergist as defined in § 170.3(o)(31) 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 practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 1.3 percent for baked goods as defined in § 170.3(n)(1) of this chapter, 3.0 percent for confections and frostings as defined in § 170.3(n)(9) of this chapter, 0.5 percent for frozen dairy desserts and mixes as defined in § 170.3(n)(20) of this chapter, 0.4 percent for gelatins and puddings as defined in § 170.3(n)(22) of this chapter, 0.5 percent for grain products and pastas as defined in § 170.3(n)(23) of this chapter, 0.35 percent for processed vegetables as defined in § 170.3(n)(36) of this chapter, and 0.07 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1240   Carbon dioxide.
(a) Carbon dioxide (empirical formula CO 2 , CAS Reg. No. 124-38-9) occurs as a colorless, odorless, noncombustible gas at normal temperatures and pressures. The solid form, dry ice, sublimes under atmospheric pressure at a temperature of −78.5 °C. Carbon dioxide is prepared as a byproduct of the manufacture of lime during the “burning” of limestone, from the combustion of carbonaceous material, from fermentation processes, and from gases found in certain natural springs and wells.
(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 leavening agent as defined in § 170.3(o)(17) of this chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; and 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.
§ 184.1245Beta-carotene.
(a) Beta- carotene (CAS Reg. No. 7235-40-7) has the molecular formula C 40 H 56 . It is synthesized by saponification of vitamin A acetate. The resulting alcohol is either reacted to form vitamin A Wittig reagent or oxidized to vitamin A aldehyde. Vitamin A Wittig reagent and vitamin A aldehyde are reacted together to form beta -carotene.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 73, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washingtion, 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: dairy product analogs as defined in § 170.3(n)(10) of this chapter; fats and oils as defined in § 170.3(n)(12) of this chapter; and processed fruits and fruit juices as defined in § 170.3(n)(35) of this chapter. Beta -carotene may be used in infant formula as a source of vitamin A in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act or with regulations promulgated under section 412(g) of the act.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1250   Cellulase enzyme preparation derived from Trichoderma longibrachiatum.
(a) Cellulase enzyme preparation is derived from a nonpathogenic, nontoxicogenic strain of Trichoderma longibrachiatum (formerly T. reesei ). The enzyme, cellulase, catalyzes the endohydrolysis of 1,4-beta-glycosidic linkages in cellulose. It is obtained from the culture filtrate resulting from a pure culture fermentation process.
(b) The ingredient meets the general and additional requirements for enzyme preparations in the monograph specifications on enzyme preparations in the “Food Chemicals Codex,” 4th ed. (1996), pp. 129 to 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., Box 285, Washington, DC 20055 (Internet 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 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 enzyme as defined in § 170.3(o)(9) of this chapter for the breakdown of cellulose.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
§ 184.1257   Clove and its derivatives.
(a) Cloves are the dried unopened flower buds and calyx tubes, harvested before the flowers have opened, of the clove tree Eugenia caryophyllata Thunberg, native to tropical Asia. Their derivatives include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves, CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol, CAS Reg. No. 97-53-0), oleoresins, and natural extractives obtained from clove buds, leaves, and stems.
(b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet the specifications of the “Food Chemicals Codex,” 4th ed. (1996), pp. 104-105, 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. As determined by analytical methods in the “Food Chemicals Codex,” clove oleoresin or other natural extractives (other than clove oils) meet the “Food Chemicals Codex” specifications for clove (clove bud) oil and the following modifications:
(1) The assay for phenols, as eugenol, by the “Food Chemicals Codex” test, 4th ed. (pp. 104-105), or the volatile oils content by the “Food Chemicals Codex” test, 4th ed. (pp. 104-105) should conform to the representation of the vendor;
(2) Optical rotation of the volatile oil between −2° and 0°;
(3) Refractive index of the volatile oil between 1.527 and 1.538 at 20 °C;
(4) Specific gravity of the volatile oil between 1.036 and 1.060; and
(5) Residual solvent free, except those solvents that are GRAS or within tolerance levels as specified in part 173, subpart C, of this chapter.
(c) Clove and its derivatives are used as flavoring agents and adjuvants as defined in § 170.3(0)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1).
(e) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.
§ 184.1259   Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-oleoyl-3-stearin is “cocoa butter substitute primarily from palm oil.” The common or usual name for the triglyceride 1-3-distearoyl-2-olein is “cocoa butter substitute primarily from high-oleic safflower or sunflower oil.”
(1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured by:
(i) Directed esterification of fully saturated 1,3-diglycerides (derived from palm oil) with the anhydride of food-grade oleic acid in the presence of the catalyst trifluoromethane sulfonic acid (§ 173.395 of this chapter), or
(ii) By interesterification of partially saturated 1,2,3-triglycerides (derived from palm oil) with ethyl stearate in the presence of a suitable lipase enzyme preparation that is either generally recognized as safe (GRAS) or has food additive approval for such use.
(2) The ingredient 1-3-distearoyl-2-olein is manufactured by interesterification of partially unsaturated 1,2,3-triglycerides (derived from high-oleic safflower or sunflower oil) with ethyl stearate or stearic acid in the presence of a suitable lipase enzyme preparation that is either GRAS or has food additive approval for such use.
(b) The ingredient meets the following specifications:
(1) Over 90 percent triglycerides, not more than 7 percent diglycerides, not more than 1 percent monoglycerides, and not more than 1 percent free fatty acids.
(2) Total glycerides—98 percent minimum.
(3) Heavy metals (as lead), not more than 10 milligrams per kilogram, as determined by the Heavy Metals Test of the “Food Chemicals Codex,” 4th ed. (1996), pp. 760-761, 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.
(4) Color—clear, bright, and free from suspended matter.
(5) Odor and taste—free from foreign and rancid odor and taste.
(6) Residual catalyst (“Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 25.049-25.055, which is incorporated by reference), residual fluorine; limit of detection 0.2 part per million F; multiply fluoride result by 2.63 to convert to residual catalyst. Copies of the material incorporated by reference may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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. The ingredient shall be washed three times in batches with 0.5 percent sodium bicarbonate to remove catalyst residuals in accordance with good manufacturing practice.
(7) Residual methanol—5 parts per million maximum.
(8) Residual fatty acid ethyl esters—not more than 20 parts per million as determined by a “Modification of Japan Institute of Oils and Fats: Analysis Method of Residual Ethyl Esters of Fatty Acids” issued by the Fuji Oil Co., which is incorporated by reference. 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 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.
(9) Hexane—not more than 5 parts per million as determined by the method of Dupuy et al., “Rapid Quantitative Determination of Residual Hexane in Oils by Direct Gas Chromatography,” published in the “Journal of the American Oil Chemists' Society,” Vol. 52, p. 118-120, 1975, which is incorporated by reference. Copies are available from the Division of Food and Color Additives, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c) In accordance with § 184.1(b)(1), the ingredient is used in the following food categories at levels not to exceed current good manufacturing practice: 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; except that the ingredient may not be used in a standardized food unless permitted by the standard of identity.
(d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels not to exceed good manufacturing practice.
§ 184.1260   Copper gluconate.
(a) Copper gluconate (cupric gluconate (CH 2 OH(CHOH) 4 COO) 2 Cu, CAS Reg. No. 527-09-3) is a substance that occurs as light blue to bluish-green, odorless crystals, or as a fine, light blue powder. It is prepared by the reaction of gluconic acid solutions with cupric oxide or basic cupric carbonate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 90, 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 as a synergist as defined in § 170.3(o)(31) of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Copper gluconate 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.
§ 184.1261   Copper sulfate.
(a) Copper sulfate (cupric sulfate, CuSO 4 ·5 H 2 O, CAS Reg. No. 7758-99-8) usually is used in the pentahydrate form. This form occurs as large, deep blue or ultramarine, triclinic crystals; as blue granules, or as a light blue powder. The ingredient is prepared by the reaction of sulfuric acid with cupric oxide or with copper metal.
(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 and 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. Copper sulfate 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.
§ 184.1262   Corn silk and corn silk extract.
(a) Corn silk is the fresh styles and stigmas of Zea mays L. collected when the corn is in milk. The filaments are extracted with dilute ethanol to produce corn silk extract. The extract may be concentrated at a temperature not exceeding 60 °C.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(2), the ingredients are used in food only within the following specific limitations:
1 Parts per million.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1265   Cuprous iodide.
(a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681-65-4) is a pure white crystalline powder. It is prepared by the reaction of copper sulfate with potassium iodide under slightly acidic conditions.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1271   L-Cysteine.
(a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid (C 3 H 7 O 2 NS).
(b) The ingredient meets the appropriate part of the specification set forth in the “Food Chemicals Codex,” 3d Ed. (1981), pp. 92-93, 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 to supply up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) of this chapter in yeast-leavened baked goods and baking mixes as defined in § 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use of this ingredient in order to affirm as GRAS the specific use named.
§ 184.1272   L-Cysteine monohydrochloride.
(a) L-Cysteine monohydrochloride is the chemical L-2-amino-3-mercaptopropanoic acid monohydrochloride monohydrate (C 3 H 7 O 2 NS HCl H 2 O).
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 92-93, 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 to supply up to 0.009 part of total L-cysteine per 100 parts of flour in dough as a dough strengthener as defined in § 170.3(o)(6) of this chapter in yeast-leavened baked goods and baking mixes as defined in § 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use of this ingredient in order to affirm as GRAS the specific use named.
§ 184.1277   Dextrin.
(a) Dextrin ((C 6 H 10 O 5 ) n ·H 2 O, CAS Reg. No. 9004-53-9) is an incompletely hydrolyzed starch. It is prepared by dry heating corn, waxy maize, waxy milo, potato, arrowroot, wheat, rice, tapioca, or sago starches, or by dry heating the starches after: (1) Treatment with safe and suitable alkalis, acids, or pH control agents and (2) drying the acid or alkali treated starch.
(b) The ingredient meets the specification of the Food Chemicals Codex, 3d Ed. (1981), p. 96, 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; as a processing aid as defined in § 170.3(o)(24) of this chapter; as a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and as a surface-finishing agent as defined in § 170.3(o)(30) 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.
§ 184.1278   Diacetyl.
(a) Diacetyl (C 4 H 6 O 2 , CAS Reg. No. 431-03-8) is a clear yellow to yellowish green liquid with a strong pungent odor. It is also known as 2,3-butanedione and is chemically synthesized from methyl ethyl ketone. It is miscible in water, glycerin, alcohol, and ether, and in very dilute water solution, it has a typical buttery odor and flavor.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 368, 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.
(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.
§ 184.1282   Dill and its derivatives.
(a) Dill (American or European) is the herb and seeds from Anethum graveolens L., and dill (Indian) is the herb and seeds from Anethum sowa, D.C. Its derivatives include essential oils, oleoresins, and natural extractives obtained from these sources of dill.
(b) Dill oils meet the description and specifications of the “Food Chemicals Codex,” 4th ed. (1996), pp. 122-123, 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) Dill and its derivatives are used as flavoring agents and adjuvants as defined in § 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good manufacturing practice.
(e) [Reserved]
(f) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.
§ 184.1287   Enzyme-modified fats.
(a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and enzyme-modified steam-rendered chicken fat are prepared from refined beef fat; butterfat or milkfat; and steam-rendered chicken fat, respectively, with enzymes that are generally recognized as safe (GRAS). Enzyme-modified milk powder may be prepared with GRAS enzymes from reconstituted milk powder, whole milk, condensed or concentrated whole milk, evaporated milk, or milk powder. The lipolysis is maintained at a temperature that is optimal for the action of the enzyme until appropriate acid development is attained. The enzymes are then inactivated. The resulting product is concentrated or dried.
(b) The ingredients must be of a purity suitable for their intended use.
(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 flavoring agents and adjuvants as defined in § 170.3(o)(12) of this chapter.
(2) The 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.
§ 184.1293   Ethyl alcohol.
(a) Ethyl alcohol (ethanol) is the chemical C 2 H 5 OH.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), p. 136, 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 as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter on pizza crusts prior to final baking at levels not to exceed 2.0 percent by product weight.
(d) This regulation is issued prior to general evaluation of use of this ingredient in order to affirm as GRAS the specific use named.
§ 184.1295   Ethyl formate.
(a) Ethyl formate (C 3 H 6 O 2 , CAS Reg. No. 109-94-4) is also referred to as ethyl methanoate. It is an ester of formic acid and is prepared by esterification of formic acid with ethyl alcohol or by distillation of ethyl acetate and formic acid in the presence of concentrated sulfuric acid. Ethyl formate occurs naturally in some plant oils, fruits, and juices but does not occur naturally in the animal kingdom.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 376, 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 0.05 percent in baked goods as defined in § 170.3(n)(1) of this chapter; 0.04 percent in chewing gum as defined in § 170.3(n)(6), hard candy as defined in § 170.3(n)(25), and soft candy as defined in § 170.3(n)(38) of this chapter; 0.02 percent in frozen dairy desserts as defined in § 170.3(n)(20) of this chapter; 0.03 percent in gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; and 0.01 percent in all other food categories.
(e) Prior sanctions for ethyl formate different from the uses established in this section do not exist or have been waived.
§ 184.1296   Ferric ammonium citrate.
(a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared by the reaction of ferric hydroxide with citric acid, followed by treatment with ammonium hydroxide, evaporating, and drying. The resulting product occurs in two forms depending on the stoichiometry of the initial reactants.
(1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1332-98-5) is a complex salt of undetermined structure composed of 16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65 percent citric acid and occurs as reddish brown or garnet red scales or granules or as a brownish-yellowish powder.
(2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg. No. 1333-00-2) is a complex salt of undetermined structure composed of 14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75 percent citric acid and occurs as thin transparent green scales, as granules, as a powder, or as transparent green crystals.
(b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and p. 117 (Ferric ammonium citrate, green), 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 as nutrient supplements as defined in § 170.3(o)(20) of this chapter, with no limitation other than current good manufacturing practice. The ingredients may also be used in infant formula 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(a)(2)).
(d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.
§ 184.1297   Ferric chloride.
(a) Ferric chloride (iron (III) chloride, FeC1 3 , CAS Reg. No. 7705-08-0) may be prepared from iron and chlorine or from ferric oxide and hydrogen chloride. The pure material occurs as hydroscopic, hexagonal, dark crystals. Ferric chloride hexahydrate (iron (III) chloride hexahydrate, FeC1 3 . 6H 2 0, CAS Reg. No. 10025-77-1) is readily formed when ferric chloride is exposed to moisture.
(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 as a flavoring agent as defined in § 170.3(o)(12) of this chapter, 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.
§ 184.1298   Ferric citrate.
(a) Ferric citrate (iron (III) citrate, C 6 H 5 FeO 7 , CAS Reg. No. 2338-05-8) is prepared from reaction of citric acid with ferric hydroxide. It is a compound of indefinite ratio of citric acid and iron.
(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 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1301   Ferric phosphate.
(a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, FePO 4 ·xH 2 O, CAS Reg. No. 10045-86-0) is an odorless, yellowish-white to buff-colored powder and contains from one to four molecules of water of hydration. It is prepared by reaction of sodium phosphate with ferric chloride or ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 118-120, 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 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1304   Ferric pyrophosphate.
(a) Ferric pyrophosphate (iron (III) pyrophosphate, Fe 4 (P 207 ) 3 ·xH 2 O, CAS Reg. No. 10058-44-3) is a tan or yellowish white colorless powder. It is prepared by reacting sodium pyrophosphate with ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 120, 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1307   Ferric sulfate.
(a) Ferric sulfate (iron (III) sulfate, Fe 2 (SO 4 ) 3 CAS Reg. No. 10028-22-5) is a yellow substance that may be prepared by oxidizing iron (II) sulfate or by treating ferric oxide or ferric hydroxide with sulfuric acid.
(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 as a flavoring agent as defined in § 170.3(o)(12) of this chapter, 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.
§ 184.1307a   Ferrous ascorbate.
(a) Ferrous ascorbate (CAS Reg. No. 24808-52-4) is a reaction product of ferrous hydroxide and ascorbic acid. It is a blue-violet product containing 16 percent iron.
(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 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1307b   Ferrous carbonate.
(a) Ferrous carbonate (iron (II) carbonate, FeCO 3 , CAS Reg. No. 563-71-3) is an odorless, white solid prepared by treating solutions of iron (II) salts with alkali carbonate salts.
(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 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 infant formula in accordance with section 412(g) of the Federal Foods, 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1307c   Ferrous citrate.
(a) Ferrous citrate (iron (II) citrate, (C 6 H 6 FeO 7 ), CAS Reg. No. 23383-11-1) is a slightly colored powder or white crystals. It is prepared from the reaction of sodium citrate with ferrous sulfate or by direct action of citric acid on iron filings.
(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 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1307d   Ferrous fumarate.
(a) Ferrous fumarate (iron (II) fumarate, (C 4 H 2 FeO 4 ), CAS Reg. No. 141-01-5) is an odorless, reddish-orange to reddish-brown powder. It may contain soft lumps that produce a yellow streak when crushed. It is prepared by admixing hot solutions of ferrous sulfate and sodium fumarate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 120-122, 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1308   Ferrous gluconate.
(a) Ferrous gluconate (iron (II) gluconate dihydrate, C 12 H 22 FeO 14 ·2H 2 O, CAS Reg. No. 6047-12-7) is a fine yellowish-gray or pale greenish-yellow powder or granules. It is prepared by reacting hot solutions of barium or calcium gluconate with ferrous sulfate or by heating freshly prepared ferrous carbonate with gluconic acid in aqueous solution.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 122-123, 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 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 infant formula 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(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1311   Ferrous lactate.
(a) Ferrous lactate (iron (II) lactate, C 6 H 10 FeO 6 , CAS Reg. No. 5905-52-2) in the trihydrate form is a greenish-white powder or crystalline mass. It is prepared by reacting calcium lactate or sodium lactate with ferrous sulfate, direct reaction of lactic acid with iron filings, reaction of ferrous chloride with sodium lactate, or reaction of ferrous sulfate with ammonium lactate.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, 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 as a nutrient supplement as defined in § 170.3(o)(20) of this chapter and as a color fixative for ripe olives, with no other limitation other than 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) (21 U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1315   Ferrous sulfate.
(a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, FeSO 4 ·7H 2 O, CAS Reg. No. 7782-63-0) is prepared by the action of sulfuric acid on iron. It occurs as pale, bluish-green crystals or granules. Progressive heating of ferrous sulfate heptahydrate produces ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of ferrous sulfate monohydrate (CAS Reg. No. 17375-41-6) with varying amounts of ferrous sulfate tetrahydrate (CAS Reg. No. 20908-72-9) and occurs as a grayish-white to buff-colored powder.
(b) The ingredients meet the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p. 124 (ferrous sulfate, dried), 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 as nutrient supplements as defined in § 170.3(o)(20) of this chapter and as a processing aid as defined in § 170.3(o)(24) of this chapter, with no limitation other than current good manufacturing practice. The ingredients may also be used in infant formula 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(a)(2)).
(d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.
§ 184.1316   Ficin.
(a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained from the latex of species of the genus Ficus, which include a variety of tropical fig trees. It is a white to off-white powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.3).
(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 proteins or polypeptides.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
§ 184.1317   Garlic and its derivatives.
(a) Garlic is the fresh or dehydrated bulb or cloves obtained from Allium sativum, a genus of the lily family. Its derivatives include essential oils, oleo-resins, and natural extractives obtained from garlic.
(b) Garlic oil meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 132, 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) Garlic and its derivatives are used as flavoring agents and adjuvants as defined in § 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good manufacturing practice.
(e) [Reserved]
(f) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1318   Glucono delta-lactone.
(a) Glucono delta-lactone (C 6 H 10 O 6 , CAS Reg. No. 90-80-2), also called D -gluconic acid delta-lactone or D -glucono-1,5-lactone, is the cyclic 1,5-intramolecular ester of D -gluconic acid. It is prepared by direct crystallization from the aqueous solution of gluconic acid. Gluconic acid may be produced by the oxidation of D -glucose with bromine water, by the oxidation of D -glucose by microorganisms that are nonpathogenic and nontoxicogenic to man or other animals, or by the oxidation of D -glucose with enzymes derived from these microorganisms.
(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 134, 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 curing and pickling agent as defined in § 170.3(o)(5) of this chapter, leavening agent as defined in § 170.3(o)(17) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; and sequestrant as defined in § 170.3(o)(26) of this chapter.
(2) The ingredient is used 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.
§ 184.1321   Corn gluten.
(a) Corn gluten (CAS Reg. No. 66071-96-3), also known as corn gluten meal, is the principal protein component of corn endosperm. It consists mainly of zein and glutelin. Corn gluten is a byproduct of the wet milling of corn for starch. The gluten fraction is washed to remove residual water soluble proteins. Corn gluten is also produced as a byproduct during the conversion of the starch in whole or various fractions of dry milled corn to corn syrups.
(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 and a 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.
§ 184.1322   Wheat gluten.
(a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein component of wheat and consists mainly of gliadin and glutenin. Wheat gluten is obtained by hydrating wheat flour and mechanically working the sticky mass to separate the wheat gluten from the starch and other flour components. Vital gluten is dried gluten that has retained its elastic properties.
(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 dough strengthener as defined in § 170.3(o)(6) of this chapter; a formulation aid as defined in § 170.3(o)(14) of this chapter; a nutrient supplement as defined in § 170.3(o)(20) 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; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and a texturizing agent 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.
§ 184.1323   Glyceryl monooleate.
(a) Glyceryl monooleate is prepared by esterification of commercial oleic acid that is derived either from edible sources or from tall oil fatty acids meeting the requirements of § 172.862 of this chapter. It contains glyceryl monooleate (C 21 H 40 O 4 , CAS Reg. No. 25496-72-4) and glyceryl esters of fatty acids present in commercial oleic acid.
(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 and as a solvent and vehicle as defined in § 170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes 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; chewing gum as defined in § 170.3(n)(6) of this chapter; and meat products as defined in § 170.3(n)(29) of this chapter.
(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.
§ 184.1324   Glyceryl monostearate.
(a) Glyceryl monostearate, also known as monostearin, is a mixture of variable proportions of glyceryl monostearate (C 21 H 42 O 4 , CAS Reg. No. 31566-31-1), glyceryl monopalmitate (C 19 H 38 O 4 , CAS Reg. No. 26657-96-5) and glyceryl esters of fatty acids present in commercial stearic acid. Glyceryl monostearate is prepared by glycerolysis of certain fats or oils that are derived from edible sources or by esterification, with glycerin, of stearic acid that is derived from edible sources.
(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 not exist or have been waived.
§ 184.1328   Glyceryl behenate.
(a) Glyceryl behenate is a mixture of glyceryl esters of behenic acid made from glycerin and behenic acid (a saturated C 22 fatty acid). The mixture contains predominately glyceryl dibehenate.
(b) The ingredient meets the following specifications:
(1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26 to 38 percent triglyceride, and not more than 2.5 percent free fatty acids.
(2) Behenic acid. Between 80 and 90 percent of the total fatty acid content.
(3) Acid value. Not more than 4.
(4) Saponification value. Between 145 and 165.
(5) Iodine number. Not more than 3.
(6) Heavy metals (as Pb). Not more than 10 parts per million.
(c) In accordance with § 184.1(b)(1) of this chapter, the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient is 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.
(2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice.
§ 184.1329   Glyceryl palmitostearate.
(a) Glyceryl palmitostearate is a mixture of mono-, di-, and triglyceryl esters of palmitic and stearic acids made from glycerin, palmitic acid, and stearic acid.
(b) The ingredient meets the following specifications:
(1) The substance is a mixture of mono-, di-, and triglycerides of palmitic acid and stearic acid.
(2) Heavy metals (as lead): Not more than 10 parts per million.
(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.
(2) The ingredient is used in excipient formulations for use in tablets at levels not to exceed good manufacturing practice.
§ 184.1330   Acacia (gum arabic).
(a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus Acacia, family Leguminosae.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 7, 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.
§ 184.1333   Gum ghatti.
(a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of Anogeissus latifolia, a large tree found in the dry deciduous forests of India and Ceylon.
(b) The ingredient complies with the following specifications:
(1) Viscosity of a 1-percent solution. Not less than the minimum or within the range claimed by the vendor.
(2) Limits of impurities —(i) Arsenic ( as AL ). Not more than 3 parts per million (0.0003 percent);
(ii) Ash ( acid-insoluble ). Not more than 1.75 percent;
(iii) Ash ( total ). Not more than 6.0 percent;
(iv) Heavy metals ( as Pb ). Not more than 40 parts per million (0.004 percent); and
(v) Lead. Not more than 10 parts per million (0.001 percent).
(3) Loss on drying. Not more than 14 percent dried at 105 °C for 5 hours.
(4) Identification test. Add 0.2 ml of diluted lead acetate as outlined in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), section 31.178(b), p. 529, under “Dilute Basic Lead Acetate Standard Solution,” which is incorporated by reference (Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, 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. ), to 5 ml of a cold 1-in-100 aqueous solution of the gum. An immediate, voluminous, opaque precipitate indicates acacia. A small precipitate or clear solution which produces an opaque flocculent precipitate upon the addition of 1 ml of 3 N ammonimum hydroxide indicates gum ghatti.
(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.
§ 184.1339   Guar gum.
(a) Guar gum is the natural substance obtained from the maceration of the seed of the guar plant, Cyamopsis tetragonoloba (Linne) Taub., or Cyamopsis psoraloides (Lam.) D.C.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 141, 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.
§ 184.1343   Locust (carob) bean gum.
(a) Locust (carob) bean gum is primarily the macerated endosperm of the seed of the locust (carob) bean tree, Ceratonia siliqua (Linne), a leguminous evergreen tree, with lesser quantities of seed coat and germ.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 174-175, 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 at levels not to exceed the following maximum levels:
Maximum Usage Levels Permitted
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.
§ 184.1349   Karaya gum (sterculia gum).
(a) Karaya gum (sterculia gum) is the dried gummy exudate from the trunk of trees of various species of the genus Sterculia.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 157, 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.
§ 184.1351   Gum tragacanth.
(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.
§ 184.1355   Helium.
(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.
§ 184.1366   Hydrogen peroxide.
(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.
§ 184.1370   Inositol.
(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.
§ 184.1372   Insoluble glucose isomerase enzyme preparations.
(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.
§ 184.1375   Iron, elemental.
(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 the uses established in this section do not exist or have been waived.
§ 184.1386   Isopropyl citrate.
(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.
§ 184.1387   Lactase enzyme preparation from Candida pseudotropicalis.
(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.
§ 184.1388   Lactase enzyme preparation from Kluyveromyces lactis.
(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.
§ 184.1400   Lecithin.
(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.
§ 184.1408   Licorice and licorice derivatives.
(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 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.
(3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an anhydrous basis as determined by the method in the Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by reference.
(4) Heavy metals (as Pb). Not more than 40 parts per million as determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p. 512, which is incorporated by reference.
(5) Arsenic (As). Not more than 3 parts per million as determined by the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which is incorporated by reference.
(c) In accordance with § 184.1(b)(2), these ingredients are used in food only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
§ 184.1409   Ground limestone.
(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.
§ 184.1415   Animal lipase.
(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.
§ 184.1420   Lipase enzyme preparation derived from Rhizopus niveus.
(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.
§ 184.1425   Magnesium carbonate.
(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.
§ 184.1426   Magnesium chloride.
(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.
§ 184.1428   Magnesium hydroxide.
(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.
§ 184.1431   Magnesium oxide.
(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 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.
§ 184.1434   Magnesium phosphate.
(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 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.
§ 184.1440   Magnesium stearate.
(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.