§ 184.1Substances 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…
252452252(a) Acetic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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 §…
652652652Aconitum napellusRanunculaceae.(a) Aconitic acid (1,2,3-propenetricarboxylic acid (CHO), CAS Reg. No. 000499-12-7) occurs in the leaves and tubers of L. and other 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:
Assay.http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.352352352(1) Not less than 98.0 percent of CH(COOH), 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 ), 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.,…
6521052452(a) Adipic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: ), 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.
bis-p-p-(2) The adipic acid is converted to its corresponding 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…
(a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained from certain brown algae by alkaline extraction.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
Table
| Category of food | Maximum level of use in food (as served) | Functional use |
| --- | --- | --- |
| Soup and soup mixes, § 170.3(n)(40) of this chapter | Not to exceed current good manufacturing practice | Emulsifier, emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter;…
§ 184.1012α-Amylase enzyme preparation from Bacillus stearothermophilus.
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 Its characterizing enzyme activity is α-amylase (1,4 α-D glucan glucanohydrolase (E.C. 3.2.1.1)).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing…
752652252(a) Benzoic acid is the chemical benzenecarboxylic acid (CHO), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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 §…
Ananas comosusA. bracteatus(a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation derived from the pineapples and 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).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
352252652n(a) Caprylic acid [CH(CH)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 -octanol or by fermentation and fractional distillation of the volatile fatty acids present in coconut oil.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
§ 184.1027Mixed carbohydrase and protease enzyme product.
B. licheniformis.(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
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
652852752Candida spp.Aspergillus niger(a) Citric acid (CHO, 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 , 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 fermentation liquor.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
(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).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
352652352dl04l04d04(a) Lactic acid (CHO, CAS Reg. Nos.: mixture, 598-82-3; -isomer, 79-33-4; -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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252(a) Enzyme-modified lecithin is prepared by treating lecithin with either phospholipase A (EC 3.1.1.4) or pancreatin.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
17523152(a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid (CHCOOH) (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…
452652552(a) Malic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452552652(a) Potassium acid tartrate (CHKO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
352652252(a) Propionic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
18523652252(a) Stearic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452652452(a) Succinic acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252452252352(a) Sulfuric acid (HSO, 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) with oxygen and mixing the resultant sulfur trioxide (SO) with water, or by reacting nitric oxide (NO) with sulfur dioxide and water.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
Quercus infectoria OliverQuercus.Caesalpinia spinosaRhus semialata, R. coriaria, R. galabra,R. typhia.(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 and related species of Tannic acid is also obtained by solvent extraction of the seed pods of Tara () or the nutgalls of various sumac species, including and
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
452652652(a) Food grade tartaric acid (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
§ 184.1101Diacetyl 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
Rhodophyceae(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 ).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used in food in accordance with § 184.1(b)(2) under the following conditions:
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Foods (as served) | Percent | Functions |
| --- | --- | --- |
| Baked goods and baking mixes, § 170.3(n)(1) of this chapter | 0.8 | Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, §…
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 lomentariaUndaria pinnatifida.(a) Brown algae are seaweeds of the species and 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
Gloiopeltis furcata, Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra suborbiculata, Porphyra teneraRhodymenia palmata. PorphyraRhodymeniaGloiopeltis(a) Red algae are seaweeds of the species and and are harvested principally along the coasts of Japan, Korea, China, Taiwan, and the East and West coasts of the United States. is harvested principally in southern Pacific coastal waters. The material is dried and ground or chopped for use in food.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
Table
| Category of food | Maximum level of use in food (as served) (percent) | Functional use |
| --- | --- | --- |
| Confections, frostings, § 170.3(n)(9) of this chapter | 0.4 | Stabilizer,…
452352(a) Ammonium bicarbonate (NHHCO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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 §…
452252352452352252452(a) Ammonium carbonate ((NH)CO, CAS Reg. No. 8000-73-5) is a mixture of ammonium bicarbonate (NHHCO) and ammonium carbamate (NHCOONH). 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452(a) Ammonium chloride (NHCl, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452(a) Ammonium hydroxide (NHOH, CAS Reg. No. 1336-21-6) is produced by passing ammonia gas into water.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452252652552752(a) Ammonium citrate, dibasic ((NH)HCHO, 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.
[59 FR 63896, Dec. 12, 1994, as…
452252452(a) Ammonium phosphate, monobasic (NHHPO, CAS Reg. No. 7722-76-1) is manufactured by reacting ammonia with phosphoric acid at a pH below 5.8.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452252452(a) Ammonium phosphate, dibasic ((NH)HPO, CAS Reg. No. 7783-28-0) is manufactured by reacting ammonia with phosphoric acid at a pH above 5.8.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452252452(a) Ammonium sulfate ((NH)SO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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 §…
§ 184.1148Bacterially-derived carbohydrase enzyme preparation.
Bacillus subtilisB. amyloliquefaciens.O(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 or 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 -glycosyl bonds in carbohydrates.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.http://www.fao.org.(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…
§ 184.1150Bacterially-derived protease enzyme preparation.
Bacillus subtilisB. amyloliquefaciens.(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 or 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.http://www.fao.org.(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…
252352252252(a) Bentonite (AlO4SiOnHO, 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…
652552252252(a) Benzoyl peroxide ((CHCO)O, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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:…
4521052(a) n-Butane and iso-butane (empirical formula CH, 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.
[48 FR 57270,…
252352252252(a) Calcium acetate (Ca (CHO), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
Table
| Category of food | Maximum level of use in food (as served) (percent) | Functional use |
| --- | --- | --- |
| Baked…
352(a) Calcium carbonate (CaCO, 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”.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[48 FR 52441,…
252252252(a) Calcium chloride (CaCl·2HO, CAS Reg. No. 10035-04-8) or anhydrous calcium chloride (CaCl, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
352652552752252252(a) Calcium citrate (Ca(CHO)·4HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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)…
252452252(a) Calcium gluconate ([CHOH(CHOH)COO]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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
352752652D-,L(a) Calcium glycerophosphate (CHCaOP, 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 and -α-glycerophosphate.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252(a) Calcium hydroxide (Ca(OH), CAS Reg. No. 1305-62-0) is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[49 FR 26714, June 29, 1984]
352252252352(a) Calcium iodate [Ca(IO)·HO, 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) in which iodine has been dissolved.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb.…
6521052652252(a) Calcium lactate (CHCaO. xHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[49 FR 26714, June 29, 1984]
9521652552252D-D-D-DL-(a) Calcium pantothenate ((CHNO)Ca, CAS Reg. No. of the isomer, 137-08-6) is a salt of pantothenic acid, one of the vitamins of the B complex. Only the isomer of pantothenic acid has vitamin activity, although both the isomer and the 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
6521052452(a) Calcium propionate (CHCaO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
17523552252(a) Calcium stearate (Ca(CHCOO), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452452252(a) Calcium sulfate (CaSO, CAS Reg. No. 7778-18-9 or CaSO·2HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252(a) Carbon dioxide (empirical formula CO, 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…
Beta-beta40525652(a) carotene (CAS Reg. No. 7235-40-7) has the molecular formula CH. 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 -carotene.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
§ 184.1250Cellulase enzyme preparation derived from Trichoderma longibrachiatum.
Trichoderma longibrachiatumT. reesei(a) Cellulase enzyme preparation is derived from a nonpathogenic, nontoxicogenic strain of (formerly ). 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.
http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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 ), 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…
Eugenia caryophyllata(a) Cloves are the dried unopened flower buds and calyx tubes, harvested before the flowers have opened, of the clove tree 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.
http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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 ), 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…
(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…
252452252(a) Copper gluconate (cupric gluconate (CHOH(CHOH)COO)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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452252(a) Copper sulfate (cupric sulfate, CuSO·5 HO, 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…
Zea mays(a) Corn silk is the fresh styles and stigmas of 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:
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table
| Category of food | Maximum level of use in food (as served) | Functional use |
| --- | --- | --- |
| Baked goods and baking mixes, § 170.3(n)(1) of this chapter | 30 | Flavoring agent, § 170.3(o)(12) of this chapter. |
| Nonalcoholic beverages, § 170.3(n)(3) of this chapter | 20 | Do. |
| Frozen dairy desserts, § 170.3(n)(20) of this chapter | 10 | Do. |
| Soft candy, § 170.3(n)(38) of this chapter | 20 | Do. |
| All other food categories | 4 | Do. |
Footers:
- Parts per million.
[47 FR 29953, July 9, 1982, as amended at 73 FR 8607, Feb. 14, 2008]
(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.
Table
| Category of food | Maximum treatment level in food | Functional use |
| --- | --- | --- |
| Table salt | 0.01 percent | Source of dietary iodine. |
[49 FR 24119, June 12, 1984, as amended at 73 FR 8607, Feb. 14, 2008]
352752252(a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid (CHONS).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]
352752252252(a) L-Cysteine monohydrochloride is the chemical L-2-amino-3-mercaptopropanoic acid monohydrochloride monohydrate (CHONS HCl HO).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]
6521052552n52252(a) Dextrin ((CHO)·HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452652252(a) Diacetyl (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
Anethum graveolensAnethum sowa,(a) Dill (American or European) is the herb and seeds from L., and dill (Indian) is the herb and seeds from D.C. Its derivatives include essential oils, oleoresins, and natural extractives obtained from these sources of dill.
http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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 ), 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:
(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…
(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…
252552(a) Ethyl alcohol (ethanol) is the chemical CHOH.
http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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 ), 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:
(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.
[42 FR 14653, Mar. 15,…
352652252(a) Ethyl formate (CHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
352352252(a) Ferric chloride (iron (III) chloride, FeC1, 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. 6H0, 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.
[53 FR 16864, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]
652552752(a) Ferric citrate (iron (III) citrate, CHFeO, 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.
[53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]
452252(a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate, FePO·xHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
45220752352252(a) Ferric pyrophosphate (iron (III) pyrophosphate, Fe(P)·xHO, CAS Reg. No. 10058-44-3) is a tan or yellowish white colorless powder. It is prepared by reacting sodium pyrophosphate with ferric citrate.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252452352(a) Ferric sulfate (iron (III) sulfate, Fe(SO) 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.
[53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]
(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.
[53 FR 16865, May 12, 1988, as amended at 69 FR 24512, May 4, 2004; 73 FR 8607, Feb. 14, 2008]
352(a) Ferrous carbonate (iron (II) carbonate, FeCO, 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.
[53 FR 16865, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]
652652752(a) Ferrous citrate (iron (II) citrate, (CHFeO), 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.
[53 FR 16866, May 12, 1988, as amended at 73 FR 8607, Feb. 14, 2008]
452252452(a) Ferrous fumarate (iron (II) fumarate, (CHFeO), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
125222521452252(a) Ferrous gluconate (iron (II) gluconate dihydrate, CHFeO·2HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
6521052652(a) Ferrous lactate (iron (II) lactate, CHFeO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used…
452252(a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate, FeSO·7HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredients are used in food as nutrient supplements…
Ficus,(a) Ficin (CAS Reg. No. 9001-33-6) is an enzyme preparation obtained from the latex of species of the genus 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).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing…
Allium sativum,(a) Garlic is the fresh or dehydrated bulb or cloves obtained from a genus of the lily family. Its derivatives include essential oils, oleo-resins, and natural extractives obtained from garlic.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14, 1977; 49 FR 5612, Feb. 14, 1984]
6521052652DDDDDD(a) Glucono delta-lactone (CHO, CAS Reg. No. 90-80-2), also called -gluconic acid delta-lactone or -glucono-1,5-lactone, is the cyclic 1,5-intramolecular ester of -gluconic acid. It is prepared by direct crystallization from the aqueous solution of gluconic acid. Gluconic acid may be produced by the oxidation of -glucose with bromine water, by the oxidation of -glucose by microorganisms that are nonpathogenic and nontoxicogenic to man or other animals, or by the oxidation of -glucose with enzymes derived from these microorganisms.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The…
(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…
(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…
21524052452(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 (CHO, 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…
2152425245219523852452(a) Glyceryl monostearate, also known as monostearin, is a mixture of variable proportions of glyceryl monostearate (CHO, CAS Reg. No. 31566-31-1), glyceryl monopalmitate (CHO, 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.
[54 FR 7403 Feb. 21, 1989, as amended at 73 FR 8607, Feb. 14, 2008]
2252(a) Glyceryl behenate is a mixture of glyceryl esters of behenic acid made from glycerin and behenic acid (a saturated C 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.
Behenic acid.(2) Between 80 and 90 percent of the total fatty acid content.
Acid value.(3) Not more than 4.
Saponification value.(4) Between 145 and 165.
Iodine number.(5) Not more than 3.
Heavy metals (as Pb).(6) 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…
(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.
[60 FR 63621, Dec. 12, 1995]
Acacia,(a) Acacia (gum arabic) is the dried gummy exudate from stems and branches of trees of various species of the genus family Leguminosae.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used in food under the following conditions:
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Food (as served) | Percent | Function |
| --- | --- | --- |
| Beverages and beverage bases, § 170.3(n)(3) of this chapter | 2 | Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter;…
Anogeissus latifolia,(a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of a large tree found in the dry deciduous forests of India and Ceylon.
(b) The ingredient complies with the following specifications:
Viscosity of a 1-percent solution.(1) Not less than the minimum or within the range claimed by the vendor.
Limits of impuritiesArsenicas AL(2) —(i) (). Not more than 3 parts per million (0.0003 percent);
Ashacid-insoluble(ii) (). Not more than 1.75 percent;
Ashtotal(iii) (). Not more than 6.0 percent;
Heavy metalsas Pb(iv) (). Not more than 40 parts per million (0.004 percent); and
Lead.(v) Not more than 10 parts per million (0.001 percent).
Loss on drying.(3) Not more than 14 percent dried at 105 °C for 5 hours.
Identification test.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.N(4) 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…
Cyamopsis tetragonolobaCyamopsis psoraloides(a) Guar gum is the natural substance obtained from the maceration of the seed of the guar plant, (Linne) Taub., or (Lam.) D.C.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used in food under the following conditions:
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Food (as served) | Percent | Function |
| --- | --- | --- |
| Baked goods and baking mixes, § 170.3(n)(1) of this chapter | 0.35 | Emulsifier and emulsifier salts, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener; §…
Ceratonia siliqua(a) Locust (carob) bean gum is primarily the macerated endosperm of the seed of the locust (carob) bean tree, (Linne), a leguminous evergreen tree, with lesser quantities of seed coat and germ.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used at levels not to exceed the following maximum levels:
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Food (as served) | Percent | Function |
| --- | --- | --- |
| Baked goods and baking mixes, § 170.3(n)(1) of this chapter | 0.15 | Stabilizer and thickener, § 170.3(o)(28) of this chapter. |
| Beverages and beverage…
Sterculia.(a) Karaya gum (sterculia gum) is the dried gummy exudate from the trunk of trees of various species of the genus
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used in food under the following conditions:
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Food (as served) | Percent | Function |
| --- | --- | --- |
| Frozen dairy desserts and mixes, § 170.3(n)(20) of this chapter | 0.3 | Formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, § 170.3(o)(28) of this chapter. |
| Milk products, § 170.3(n)(31) of this chapter | 0.02 | Stabilizer and…
Astragalus gummifier(a) Gum tragacanth is the exudate from one of several species of Labillardiere, a shrub that grows wild in mountainous regions of the Middle East.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) The ingredient is used in food under the following conditions:
(d) [Reserved]
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
Table: Maximum Usage Levels Permitted
| Food (as served) | Percent | Function |
| --- | --- | --- |
| Baked goods and baking mixes, § 170.3(n)(1) of this chapter | 0.2 | Emulsifier and emulsifier salt, § 170.3(o)(8) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; stabilizer and thickener, §…
(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.
[48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008]
252252(a) Hydrogen peroxide (HO, 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.
1(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 146-147, which is incorporated by reference.
(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.…
6521252652cistrans(a) Inositol, or myo-inositol (CHO, CAS Reg. No. 87-89-8), is -1,2,3,5--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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.…
§ 184.1372Insoluble glucose isomerase enzyme preparations.
Streptomyces rubiginosus, Actinoplanes missouriensis, Streptomyces olivaceus, Streptomyces olivochromogenes,Bacillus coagulans,(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 and 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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.…
(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…
§ 184.1387Lactase enzyme preparation from Candida pseudotropicalis.
C. pseudotropicalis.(a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no…
§ 184.1388Lactase enzyme preparation from Kluyveromyces lactis.
Kluyveromyces lactisSaccharomyces lactis).(a) This enzyme preparation is derived from the nonpathogenic, nontoxicogenic yeast (previously named 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[48 FR 51150, Nov. 7, 1983]
Glycyrrhiza glabraGlycyrrhiza.(a)(1) Licorice (glycyrrhiza) root is the dried and ground rhizome and root portions of or other species of 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.
425261521652452252(2) Ammoniated glycyrrhizin is prepared from the water extract of licorice root by acid precipitation followed by neutralization with dilute ammonia. Monoammonium glycyrrhizinate (CHONH5HO, 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:
Assay.Journal of the Association of Official Analytical Chemists,http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(1) 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…
352(a) Ground limestone consists essentially (not less than 94 percent) of calcium carbonate (CaCO) and is prepared by the crushing, grinding, and classifying of naturally occurring limestone.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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.
[48 FR 52442, Nov. 18, 1983]
(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).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used…
§ 184.1420Lipase enzyme preparation derived from Rhizopus niveus.
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 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).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
352452252252(a) Magnesium carbonate (molecular formula approximately (MgCO)·Mg(OH)·5HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252252(a) Magnesium chloride (MgC1·6HO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
252(a) Magnesium hydroxide (Mg(OH), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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 §…
(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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current…
452252352452252(a) Magnesium phosphate includes both magnesium phosphate, dibasic, and magnesium phosphate, tribasic. Magnesium phosphate, dibasic (MgHPO·3HO, 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(PO)2·xHO, 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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…
17523452252(a) Magnesium stearate (Mg(CHCOO), 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.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(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…
452252(a) Magnesium sulfate (MgSO·7HO, CAS Reg. No. 10034-99-8) occurs naturally as the mineral epsomite. It is prepared by neutralization of magnesium oxide, hydroxide, or carbonate with sulfuric acid and evaporating the solution to crystallization.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 183, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a nutrient supplement…
(a) Malt is an enzyme preparation obtained from barley which has been softened by a series of steeping operations and germinated under controlled conditions. It is a brown, sweet, and viscous liquid or a white to tan powder. Its characterizing enzyme activities are α-amylase (EC 3.2.1.1.) and β-amylase (EC 3.2.1.2).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Premarket Approval (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
6521052552n52(a) Maltodextrin ((CHO), CAS Reg. No. 9050-36-6) is a nonsweet nutritive saccharide polymer that consists of D-glucose units linked primarily by α-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is prepared as a white powder or concentrated solution by partial hydrolysis of corn starch, potato starch, or rice starch with safe and suitable acids and enzymes.
(b)(1) Maltodextrin derived from corn starch must be of a purity suitable for its intended use.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html..(2) Maltodextrin derived from potato starch meets the specifications of the Food Chemicals Codex, 3d ed., 3d supp. (1992), p. 125, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or at the Division of Petition Control (HFS-217), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this…
Hordeum vulgare(a) Malt is the product of barley ( L.) germinated under controlled conditions. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of water extract of germinated barley grain, with or without added safe preservative. Malt syrup is usually a brown, sweet, and viscous liquid containing varying amounts of amylolytic enzymes and plant constituents. Barley is first softened after cleaning by steeping operations and then allowed to germinate under controlled conditions. The germinated grain then undergoes processing, such as drying, grinding, extracting, filtering, and evaporating, to produce malt syrup (malt extract) with 75 to 80 percent solids or dried malt syrup with higher solids content.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and…
252252(a) Manganese chloride (MnCl, CAS Reg. No. 7773-01-5) is a pink, translucent, crystalline product. It is also known as manganese dichloride. It is prepared by dissolving manganous oxide, pyrolusite ore (MnO), or reduced manganese ore in hydrochloric acid. The resulting solution is neutralized to precipitate heavy metals, filtered, concentrated, and crystallized.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
352652552752252(a) Manganese citrate (Mn(CHO), CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. It is obtained by precipitating manganese carbonate from manganese sulfate and sodium carbonate solutions. The filtered and washed precipitate is digested first with sufficient citric acid solution to form manganous citrate and then with sodium citrate to complete the reaction.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter;…
125222521452252(a) Manganese gluconate (CHMnO·2HO, CAS Reg. No. 648-0953-0998) is a slightly pink colored powder. It is obtained by reacting manganese carbonate with gluconic acid in aqueous medium and then crystallizing the product.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 186, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
452252252(a) Manganese sulfate (MnSO·HO, CAS Reg. No. 7785-0987-097) is a pale pink, granular, odorless powder. It is obtained by reacting manganese compounds with sulfuric acid. It is also obtained as a byproduct in the manufacture of hydroquinone. Other manufacturing processes include the action of sulfur dioxide on a slurry of manganese dioxide in sulfuric acid, and the roasting of pyrolusite (MnO) ore with solid ferrous sulfate and coal, followed by leaching and crystallization.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 188, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
Menhaden oil.Brevoortia,(a) (1) Menhaden oil is prepared from fish of the genus commonly known as menhaden, by cooking and pressing. The resulting crude oil is then refined using the following steps: Storage (winterization), degumming (optional), neutralization, bleaching, and deodorization. Winterization may separate the oil and produce a solid fraction.
(2) Menhaden oil meets the following specifications:
Color and state.(i) Yellow liquid to white solid.
Odor.(ii) Odorless to slightly fishy.
Saponification value.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(iii) Between 180 and 200 as determined by the American Oil Chemists' Society Official Method Cd 3-25—“Saponification Value” (reapproved 1989), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD…
pp(a) Methylparaben is the chemical methyl -hydroxybenzoate. It is produced by the methanol esterification of -hydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 199, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(c) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter.
(d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food.
(e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.
[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984]
(a) Microparticulated protein product is prepared from egg whites or milk protein or a combination of egg whites and milk protein. These protein sources may be used alone or in combination with other safe and suitable ingredients to form the microparticulated product. The mixture of ingredients is high-shear heat processed to achieve a smooth and creamy texture similar to that of fat. Safe and suitable ingredients used in the preparation of the microparticulated protein product must be used in compliance with the limitations of the appropriate regulations in parts 172, 182, and 184 of this chapter.
(b) The ingredient is used in food in accordance with § 184.1(b)(2) at levels not to exceed current good manufacturing practice. The affirmation of the use of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following conditions of use:
(1) The ingredient is used in food as a thickener as defined in § 170.3(o)(28) of this chapter or as a texturizer as defined in § 170.3(o)(32) of this chapter.
(2) The ingredient is used in frozen dessert-type products except that the ingredient may not be used to replace the milk fat required…
(a) Mono- and diglycerides consist of a mixture of glyceryl mono- and diesters, and minor amounts of triesters, that are prepared from fats or oils or fat-forming acids that are derived from edible sources. The most prevalent fatty acids include lauric, linoleic, myristic, oleic, palmitic, and stearic. Mono- and diglycerides are manufactured by the reaction of glycerin with fatty acids or the reaction of glycerin with triglycerides in the presence of an alkaline catalyst. The products are further purified to obtain a mixture of glycerides, free fatty acids, and free glycerin that contains at least 90 percent-by-weight glycerides.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(c) In accordance…
§ 184.1521Monosodium phosphate derivatives of mono- and diglycerides.
(a) Monosodium phosphate derivatives of mono- and diglycerides are composed of glyceride derivatives formed by reacting mono- and diglycerides that are derived from edible sources with phosphorus pentoxide (tetraphosphorus decoxide) followed by neutralization with sodium carbonate.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used in food as an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter, a lubricant and release agent as defined in § 170.3(o)(18) of this chapter, and as a surface-active agent as defined in § 170.3(o)(29) of this chapter.
(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: dairy product analogs as defined in § 170.3(n)(10) of this chapter and soft candy as defined in § 170.3(n)(38) of this chapter.
(d)…
652552252(a) Niacin (CHNO, CAS Reg. No. 59-67-6) is the chemical 3-pyridinecarboxylic acid (nicotinic acid). It is a non-hygroscopic, stable, white, crystalline solid that sublimes without decomposition at about 230 °C. It is soluble in water and alcohol. It is insoluble in ether.
http://www.nap.eduhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), p. 264, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address ), 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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing…
652652252(a) Niacinamide (CHNO, CAS Reg. No. 98-92-0) is the chemical 3-pyridinecarboxylic acid amide (nicotinamide). It is a white crystalline powder that is soluble in water, alcohol, ether, and glycerol. It melts between 128° and 131 °C.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 205, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
352252(a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from nickel ore by transforming it to nickel sulfide (NiS). The sulfide is roasted in air to give nickel oxide (NiO). The oxide is then reduced with carbon to give elemental nickel.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a catalyst as defined in § 170.3(o)(24) of this chapter.
(2) The ingredient is used in the hydrogenation of fats and oils as defined in § 170.3(n)(12) of this chapter at levels not to exceed current good manufacturing practice. Current good manufacturing practice includes the removal of nickel from fats and oils following hydrogenation.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
[48 FR 51618, Nov. 10, 1983, as amended at 73 FR 8607,…
(a) Nisin preparation is derived from pure culture fermentations of certain strains of Streptococcus lactis Lancefield Group N. Nisin preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related peptides with antibiotic activity.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient is a concentrate or dry material that meets the specifications that follow when it is tested as described in “Specifications for Identity and Purity of Some Antibiotics,” World Health Organization, FAO Nutrition Meeting Report Series, No. 45A, 1969, which is incorporated by reference. Copies are available from the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(1) Nisin content, not less than 900 international units per milligram.
(2) Arsenic, not more than 1 part per million.
(3) Lead, not more than 2 parts per million.
(4)…
252(a) Nitrogen (empirical formula N, CAS Reg. No. 7727-37-9) is a colorless, odorless, flavorless gas that is produced commercially by the fractionation of liquid air.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas as defined in § 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
[48 FR 57270, Dec. 29, 1983, as amended at 73 FR 8607, Feb. 14, 2008]
252(a) Nitrous oxide (empirical formula NO, CAS Reg. No. 10024-97-2) is also known as dinitrogen monoxide or laughing gas. It is a colorless gas, about 50 percent heavier than air, with a slightly sweet smell. It does not burn but will support combustion. Nitrous oxide is manufactured by the thermal decomposition of ammonium nitrate. Higher oxides of nitrogen are removed by passing the dry gas through a series of scrubbing towers.
(b) The ingredient must be of a purity suitable for its intended use.
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas as defined in § 170.3(o)(25) of this chapter.
(2) The ingredient is used in dairy product analogs as defined in § 170.3(n)(10) of this chapter at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses established in this…
(a) Peptones are a variable mixture of polypeptides, oligopeptides, and amino acids that are produced by partial hydrolysis of casein, animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg albumin, or lactalbumin (whey protein). Peptones are produced from these proteins using proteolytic enzymes that either are considered to be generally recognized as safe (GRAS) or are regulated as food additives. Peptones are also produced by denaturing any of the proteins listed in this paragraph with safe and suitable acids or heat.
(b) The ingredients must be of a purity suitable for their intended use.
(c) In accordance with § 184.1(b)(1), these ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as GRAS as direct human food ingredients is based upon the following current good manufacturing practice conditions of use:
(1) These ingredients are used as nutrient supplements as defined in § 170.3(o)(20) of this chapter; as processing aids as defined in § 170.3(o)(24) of this chapter; and as surface-active agents as defined in § 170.3(o)(29) of this chapter.
(2) These ingredients are used in…
Fully hydrogenated rapeseed oil.napuscampestrisBrassica(a) (1) Fully hydrogenated rapeseed oil is a mixture of triglycerides in which the fatty acid composition is a mixture of saturated fatty acids. The fatty acids are present in the same proportions which result from the full hydrogenation of fatty acids occurring in natural rapeseed oil. The rapeseed oil is obtained from the and varieties of of the family Cruciferae. It is prepared by fully hydrogenating refined and bleached rapeseed oil at 310-375 °F, using a catalyst such as nickel, until the iodine number is 4 or less.
(2) The ingredient meets the following specifications: Acid value not more than 6, arsenic not more than 3 parts per million, free glycerin not more than 7 percent, heavy metals (as Pb) not more than 10 parts per million, iodine number not more than 4, residue on ignition not more than 0.5 percent.
(3) The ingredient is used as a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter in peanut butter. The use level of the ingredient is limited by good manufacturing practice (GMP) to the minimum amount required to produce the intended effect. Current good manufacturing practices result in a…
(a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified oxgall or sodium choleate, is a yellowish green, soft solid, with a partly sweet, partly bitter, disagreeable taste. It is the purified portion of the bile of an ox obtained by evaporating the alcohol extract of concentrated bile.
1(b) Food-grade ox bile extract shall meet the specifications of the U.S. Pharmacopeia (USP), XIV, 1950, p. 410.
(c) The ingredient is used as a surfactant as defined in § 170.3 (o)(29) of this chapter.
(d) The ingredient is used in food in accordance with § 184.1(b)(1) at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.002 percent for cheese as defined in § 170.3(n)(5) of this chapter.
(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.
1 Copies may be obtained from: U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
[43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537, Dec. 3, 1985]
352(a) Ozone (O, CAS Reg. No. 10028-15-6) is an unstable blue gas with a pungent, characteristic odor, which occurs freely in nature, It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen.
(b) The ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter.
(c) In accordance with § 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations:
Table
| Category of food | Maximum treatment level in food | Functional use |
| --- | --- | --- |
| Bottled water that prior to ozonation meets the microbiological, physical, chemical, and radiological quality standards of § 165.110 (b)(2) through (b)(5) of this chapter | Not to exceed current good manufacturing practice. Current good manufacturing practice results in a maximum residual level at the time of bottling of 0.4 milligram of ozone per liter of bottled water | Antimicrobial agent, § 170.3 (o)(2) of this chapter. |
[47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995]
(a) Pancreatin (CAS Reg. No. 8049-47-6) is an enzyme preparation obtained from porcine or bovine pancreatic tissue. It is a white to tan powder. Its characterizing enzyme activity that of a peptide hydrolase (EC 3.4.21.36).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the general requirements and additional requirements in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
Carica papaya(a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived from L. Crude latex containing the enzyme is collected from slashed unripe papaya. The food-grade product is obtained by repeated filtration of the crude latex or an aqueous solution of latex or by precipitation from an aqueous solution of latex. The resulting enzyme preparation may be used in a liquid or dry form.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 107-110, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
(a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex, high molecular weight polysaccharides found in plants and composed chiefly of partially methylated polygalacturonic acid units. Portions of the carboxly group occur as methyl esters, and the remaining carboxyl groups exist in the form of the free acid or as its ammonium, potassium, or sodium (CAS Reg. No. 9000-59-8) salts, and in some types as the acid amide. Thus, the pectins regulated in this section are the high-ester pectins, low-ester pectins, amidated pectins, pectinic acids, and pectinates. Pectin is produced commercially by extracting citrus peel, apple pomace, or beet pulp with hot dilute acid (pH 1.0 to 3.5, 70° to 90 °C). The extract is filtered, and pectin is then precipitated from the clear extract with ethanol or isopropanol, or as the copper or aluminum salt. The acid extract is sometimes spray- or roller-dried, or it is concentrated to be sold as liquid pectin.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredients meet the specifications of the Food Chemical Codex, 3d Ed. (1981), p. 215, which is incorporated by reference. Copies are available…
(a) Pepsin (CAS Reg. No. 9001-75-6) is an enzyme preparation obtained from the glandular layer of hog stomach. It is a white to light tan powder, amber paste, or clear amber to brown liquid. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.23.1).
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.…
(a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Potassium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:
(d) Prior sanctions for potassium alginate different from the uses established in this section do not exist or have been waived.
Table
| Category of food | Maximum level of use in food (as served) (percent) | Functional use |
| --- | --- | --- |
| Confections and frostings, § 170.3(n)(9) of this chapter | 0.1 |…
352(a) Potassium bicarbonate (KHCO, CAS Reg. No. 298-14-6) is made by the following processes:
(1) By treating a solution of potassium hydroxide with carbon dioxide;
(2) By treating a solution of potassium carbonate with carbon dioxide.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 239, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in § 170.3(o)(14) of this chapter; nutrient supplement as defined in…
252352(a) Potassium carbonate (KCO, CAS Reg. No. 584-08-7) is produced by the following methods of manufacture:
(1) By electrolysis of potassium chloride followed by exposing the resultant potassium to carbon dioxide;
(2) By treating a solution of potassium hydroxide with excess carbon dioxide to produce potassium carbonate;
(3) By treating a solution of potassium hydroxide with carbon dioxide to produce potassium bicarbonate, which is then heated to yield potassium carbonate.
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 240, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, D.C. 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(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…
