DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

• Citation: 21 CFR Part 184
• Sections: 215

§ 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS).

(a) The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and affirmed to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. The regulations in this part shall sufficiently describe each ingredient to identify the characteristics of the ingredient that has been affirmed as GRAS and to differentiate it from other possible versions of the ingredient that have not been affirmed as GRAS. Ingredients affirmed as GRAS in this part are also GRAS as indirect human food ingredients, subject to any limitations prescribed in parts 174, 175, 176, 177, 178 or § 179.45 of this chapter or in part 186 of this chapter. The purity specifications in this part do not apply when the ingredient is used in indirect applications. However, when used in indirect applications, the ingredient must be of a purity suitable for its intended use in accordance with § 170.30(h)(1) of this chapter.

(b) Any ingredient affirmed as GRAS in this part shall be used in accordance with current good manufacturing practice. For the purpose of this part, current good manufacturing practice includes the requirements that a direct human food ingredient be of appropriate food grade; that it be prepared and handled as a food ingredient; and that the quantity of the ingredient added to food does not exceed the amount reasonably required to accomplish the intended physical, nutritional, or other technical effect in food.

(1) If the ingredient is affirmed as GRAS with no limitations on its conditions of use other than current good manufacturing practice, it shall be regarded as GRAS if its conditions of use are consistent with the requirements of paragraph (b), (c), and (d) of this section. When the Food and Drug Administration (FDA) determines that it is appropriate, the agency will describe one or more current good manufacturing practice conditions of use in the regulation that affirms the GRAS status of the ingredient.

For example, when the safety of an ingredient has been evaluated on the basis of limited conditions of use, the agency will describe in the regulation that affirms the GRAS status of the ingredient, one or more of these limited conditions of use, which may include the category of food(s), the technical effect(s) or functional use(s) of the ingredient, and the level(s) of use. If the ingredient is used under conditions that are significantly different from those described in the regulation, that use of the ingredient may not be GRAS.

In such a case, a manufacturer may not rely on the regulation as authorizing that use but shall have a basis to conclude that that use is GRAS or shall use the ingredient in accordance with a food additive regulation.

(2) If the ingredient is affirmed as GRAS with specific limitation(s), it shall be used in food only within such limitation(s), including the category of food(s), the functional use(s) of the ingredient, and the level(s) of use. Any use of such an ingredient not in full compliance with each such established limitation shall require a food additive regulation.

(3) If the ingredient is affirmed as GRAS for a specific use, without a general evaluation of use of the ingredient, other uses may also be GRAS.

(c) The listing of a food ingredient in this part does not authorize the use of such substance in a manner that may lead to deception of the consumer or to any other violation of the Federal Food, Drug, and Cosmetic Act (the Act).

(d) The listing of more than one ingredient to produce the same technological effect does not authorize use of a combination of two or more ingredients to accomplish the same technological effect in any one food at a combined level greater than the highest level permitted for one of the ingredients.

(e) If the Commissioner of Food and Drugs is aware of any prior sanction for use of an ingredient under conditions different from those proposed to be affirmed as GRAS, he will concurrently propose a separate regulation covering such use of the ingredient under part 181 of this chapter. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the Act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under part 181 of this chapter, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.

(f) The label and labeling of the ingredient and any intermediate mix of the ingredient for use in finished food shall bear, in addition to the other labeling required by the Act:

(1) The name of the ingredient, except where exempted from such labeling in part 101 of this chapter.

(2) A statement of concentration of the ingredient in any intermediate mix; or other information to permit a food processor independently to determine that use of the ingredients will be in accordance with any limitations and good manufacturing practice guidelines prescribed.

(3) Adequate directions for use to provide a final food product that complies with any limitations prescribed for the ingredient(s).

§ 184.1005 Acetic acid.

(a) Acetic acid (C 2 H 4 O 2 , CAS Reg. No. 64-19-7) is known as ethanoic acid. It occurs naturally in plant and animal tissues. It is produced by fermentation of carbohydrates or by organic synthesis. The principal synthetic methods currently employed are oxidation of acetaldehyde derived from ethylene, liquid phase oxidation of butane, and reaction of carbon monoxide with methanol derived from natural gas.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 8, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a curing and pickling agent as defined in § 170.3(o)(5) of this chapter; flavor enhancer as defined in § 170.3(o)(11) of this chapter; flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; as a solvent and vehicle as defined in § 170.3(o)(27) of this chapter; and as a boiler water additive complying with § 173.310 of this chapter.

(d) The ingredient is used in food at levels not to exceed current good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level as served, of 0.25 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.8 percent for cheeses as defined in § 170.3(n)(5) of this chapter and dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.5 percent for chewing gum as defined in § 170.3(n)(6) of this chapter; 9.0 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.5 percent for fats and oils as defined in § 170.3(n)(12) of this chapter; 3.0 percent for gravies and sauces as defined in § 170.3(n)(24) of this chapter; 0.6 percent for meat products as defined in § 170.3(n)(29) of this chapter; and 0.15 percent or less for all other food categories. The ingredient may also be used in boiler water additives at levels not to exceed current good manufacturing practice.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1007 Aconitic acid.

(a) Aconitic acid (1,2,3-propenetricarboxylic acid (C 6 H 6 O 6 ), CAS Reg. No. 000499-12-7) occurs in the leaves and tubers of Aconitum napellus L. and other Ranunculaceae. Transaconitic acid can be isolated during sugarcane processing, by precipitation as the calcium salt from cane sugar or molasses. It may be synthesized by sulfuric acid dehydration of citric acid, but not by the methanesulfonic acid method.

(b) The ingredient meets the following specifications:

(1) Assay. Not less than 98.0 percent of C 3 H 3 (COOH) 3 , using the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, test for citric acid, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and a molecular weight of 174.11. Copies of the material incorporated by reference are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Melting point. Not less than 195 °C and the determination results in decomposition of aconitic acid.

(3) Heavy metals ( as Pb ). Not more than 10 parts per million.

(4) Arsenic ( as As ). Not more than 3 parts per million.

(5) Oxalate. Passes test.

(6) Readily carbonizable substances. Passes the test for citric acid of the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(7) Residue on ignition. Not more than 0.1 percent as determined by the “Food Chemicals Codex,” 4th ed. (1996), pp. 102-103, test for citric acid, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(c) The ingredient is used as a flavoring substance and adjuvant as defined in § 170.3(o)(12) of this chapter.

(d) The ingredient is used in food, in accordance with § 184.1(b)(1), at levels not to exceed good manufacturing practice. Current good manufacturing practice results in a maximum level, as served, of 0.003 percent for baked goods as defined in § 170.3(n)(1) of this chapter, 0.002 percent for alcoholic beverages as defined in § 170.3(n)(2) of this chapter, 0.0015 percent for frozen dairy products as defined in § 170.3(n)(20) of this chapter, 0.0035 percent for soft candy as defined in § 170.3(n)(38) of this chapter, and 0.0005 percent or less for all other food categories.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1009 Adipic acid.

(a) Adipic acid (C 6 H 10 O 4 , CAS Reg. No. 00124-04-9) is also known as 1,4-butanedicarboxylic acid or hexane-dioic acid. It is prepared by nitric acid oxidation of cyclohexanol or cyclohexanone or a mixture of the two.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 11, which is incorporated by reference (Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ), and the following additional specifications:

(1) The adipic acid is converted to its corresponding amide. The amide is purified by recrystallization from water or aqueous ethanol. The melting range of the amide is 219° to 220 °C.

(2) The adipic acid is converted to its corresponding bis-p-p- bromophenacyl ester. The ester is purified by recrystallization from ethanol. The melting range of the ester is 153° to 154 °C.

(c) The ingredient is used as a flavoring agent as defined in § 170.3(o)(12) of this chapter; leavening agent as defined in § 170.3(o)(17) of this chapter; and pH control agent as defined in § 170.3(o)(23) of this chapter.

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in maximum levels, as served, of 0.05 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.005 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; 5.0 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.45 percent for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.3 percent for fats and oil as defined in § 170.3(n)(12) of this chapter; 0.0004 percent for frozen dairy desserts as defined in § 170.3(n)(20) of this chapter; 0.55 percent for gelatin and puddings as defined in § 170.3(n)(22) of this chapter; 0.1 percent for gravies as defined in § 170.3(n)(24) of this chapter; 0.3 percent for meat products as defined in § 170.3(n)(29) of this chapter; 1.3 percent for snack foods as defined in § 170.3(n)(37) of this chapter; and 0.02 percent or less for all other food categories.

(e) Prior sanctions for adipic acid different from the uses established in this section do not exist or have been waived.

§ 184.1011 Alginic acid.

(a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained from certain brown algae by alkaline extraction.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 13, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

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; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.

§ 184.1012 α-Amylase enzyme preparation from Bacillus stearothermophilus.

(a) α-Amylase enzyme preparation is obtained from the culture filtrate that results from a pure culture fermentation of a nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus. Its characterizing enzyme activity is α-amylase (1,4 α-D glucan glucanohydrolase (E.C. 3.2.1.1)).

(b) The ingredient meets the general and additional requirements for enzyme preparations in the “Food Chemicals Codex,” 3d ed. (1981), pp. 107-110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practices. The affirmation of this ingredient as GRAS as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme, as defined in § 170.3(o)(9) of this chapter, in the hydrolysis of edible starch to produce maltodextrins and nutritive carbohydrate sweeteners.

(2) The ingredient is used at levels not to exceed current good manufacturing practices.

§ 184.1021 Benzoic acid.

(a) Benzoic acid is the chemical benzenecarboxylic acid (C 7 H 6 O 2 ), occurring in nature in free and combined forms. Among the foods in which benzoic acid occurs naturally are cranberries, prunes, plums, cinnamon, ripe cloves, and most berries. Benzoic acid is manufactured by treating molten phthalic anhydride with steam in the presence of a zinc oxide catalyst, by the hydrolysis of benzotrichloride, or by the oxidation of toluene with nitric acid or sodium bichromate or with air in the presence of a transition metal salt catalyst.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 35, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter.

(d) The ingredient is used in food at levels not to exceed good manufacturing practice. Current usage results in a maximum level of 0.1 percent in food. (The Food and Drug Administration has not determined whether significantly different conditions of use would be GRAS).

(e) Prior sanctions for this ingredient different from those uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived.

§ 184.1024 Bromelain.

(a) Bromelain (CAS Reg. No. 9001-00-7) is an enzyme preparation derived from the pineapples Ananas comosus and A. bracteatus L. It is a white to light tan amorphous powder. Its characterizing enzyme activity is that of a peptide hydrolase (EC 3.4.22.32).

(b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC, or may be examined at Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

§ 184.1025 Caprylic acid.

(a) Caprylic acid [CH 3 (CH 2 ) 6 COOH, CAS Reg. No. 124-07-2] is the chemical name for octanoic acid. It is considered to be a short or medium chain fatty acid. It occurs normally in various foods and is commercially prepared by oxidation of n -octanol or by fermentation and fractional distillation of the volatile fatty acids present in coconut oil.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 207, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter.

(d) The ingredient is used in foods in accordance with § 184.1(b)(1), at levels not to exceed good manufacturing practice. Current good manufacturing practices result in maximum levels, as served, of: 0.013 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.04 percent for cheeses as defined in § 170.3(n)(5) of this chapter; 0.005 percent for fats and oils as defined in § 170.3(n)(12) of this chapter, for frozen dairy desserts as defined in § 170.3(n)(20) of this chapter, for gelatins and puddings as defined in § 170.3(n)(22) of this chapter, for meat products as defined in § 170.3(n)(29) of this chapter, and for soft candy as defined in § 170.3(n)(38) of this chapter; 0.016 percent for snack foods as defined in § 170.3(n)(37) of this chapter; and 0.001 percent or less for all other food categories.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1027 Mixed carbohydrase and protease enzyme product.

(a) Mixed carbohydrase and protease enzyme product is an enzyme preparation that includes carbohydrase and protease activity. It is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic strain of B. licheniformis.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 107, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme, as defined in § 170.3(o)(9) of this chapter, to hydrolyze proteins or carbohydrates.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: alcoholic beverages, as defined in § 170.3(n)(2) of this chapter, candy, nutritive sweeteners, and protein hydrolyzates.

§ 184.1033 Citric acid.

(a) Citric acid (C 6 H 8 O 7 , CAS Reg. No. 77-92-9) is the compound 2-hydroxy-1,2,3-propanetricarboxylic acid. It is a naturally occurring constituent of plant and animal tissues. It occurs as colorless crystals or a white powder and may be anhydrous or contain one mole of water per mole of citric acid. Citric acid may be produced by recovery from sources such as lemon or pineapple juice; by mycological fermentation using Candida spp. , described in §§ 173.160 and 173.165 of this chapter; and by the solvent extraction process described in § 173.280 of this chapter for the recovery of citric acid from Aspergillus niger fermentation liquor.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992), pp. 107-108, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitations other than current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1034 Catalase (bovine liver).

(a) Catalase (bovine liver) (CAS Reg. No. 81457-95-6) is an enzyme preparation obtained from extracts of bovine liver. It is a partially purified liquid or powder. Its characterizing enzyme activity is catalase (EC 1.11.1.6).

(b) The ingredient meets the general requirements and additional requirements for enzyme preparations in the Food Chemicals Codex, 3d ed. (1981), p. 110, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave., NW., Washington, DC 20418, or may be examined at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to decompose hydrogen peroxide.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

§ 184.1061 Lactic acid.

(a) Lactic acid (C 3 H 6 O 3 , CAS Reg. Nos.: dl mixture, 598-82-3; l -isomer, 79-33-4; d -isomer, 10326-41-7), the chemical 2-hydroxypropanoic acid, occurs naturally in several foods. It is produced commercially either by fermentation of carbohydrates such as glucose, sucrose, or lactose, or by a procedure involving formation of lactonitrile from acetaldehyde and hydrogen cyanide and subsequent hydrolysis to lactic acid.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 159, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Avenue, NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter; a curing and pickling agent as defined in § 170.3(o)(5) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; and a solvent and vehicle as defined in § 170.3(o)(27) of this chapter.

(2) The ingredient is used in food, except in infant foods and infant formulas, at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1063 Enzyme-modified lecithin.

(a) Enzyme-modified lecithin is prepared by treating lecithin with either phospholipase A 2 (EC 3.1.1.4) or pancreatin.

(b) The ingredient meets the specifications in paragraphs (b)(1) through (b)(8) of this section. Unless otherwise noted, compliance with the specifications listed below is determined according to the methods set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 220-221, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington DC 20418, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Acetone-insoluble matter (phosphatides), not less than 50.0 percent.

(2) Acid value, not more than 40.

(3) Lead, not more than 1.0 part per million, as determined by atomic absorption spectroscopy.

(4) Heavy metals (as Pb), not more than 20 parts per million.

(5) Hexane-insoluble matter, not more than 0.3 percent.

(6) Peroxide value, not more than 20.

(7) Water, not more than 4.0 percent.

(8) Lysolecithin, 50 to 80 mole percent of total phosphatides as determined by “Determination of Lysolecithin Content of Enzyme-Modified Lecithin: Method I,” dated 1985, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an emulsifier as defined in § 170.3(o)(8) of this chapter.

(2) The ingredient is used at levels not to exceed current good manufacturing practice.

§ 184.1065 Linoleic acid.

(a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid (C 17 H 31 COOH) (CAS Reg. No. 60-33-3)), a straight chain unsaturated fatty acid with a molecular weight of 280.5, is a colorless oil at room temperature. Linoleic acid may be prepared from edible fats and oils by various methods including hydrolysis and saponification, the Twitchell method, low pressure splitting with catalyst, continuous high pressure counter current splitting, and medium pressure autoclave splitting with catalyst.

(b) The ingredient must be of a purity suitable for its intended use. The ingredient must also meet the specifications in § 172.860(b) of this chapter.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter and as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1069 Malic acid.

(a) Malic acid (C 4 H 6 O 5 , CAS Reg. No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic acid, occurs naturally in various foods. Racemic DL-malic acid does not occur naturally. It is made commercially by hydration of fumaric acid or maleic acid.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 183-184, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredients are used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, and pH control agent as defined in § 170.3(o)(23) of this chapter.

(d) The ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 3.4 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in § 170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; 6.9 percent for hard candy as defined in § 170.3(n)(25) of this chapter; 2.6 percent for jams and jellies as defined in § 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as defined in § 170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in § 170.3(n)(38) of this chapter; and 0.7 percent for all other food categories.

(e) Prior sanctions for malic acid different from the uses established in this section do not exist or have been waived.

§ 184.1077 Potassium acid tartrate.

(a) Potassium acid tartrate (C 4 H 5 KO 6 , CAS Reg. No. 868-14-4) is the potassium acid salt of l−(+)−tartaric acid and is also called potassium bitartrate or cream of tartar. It occurs as colorless or slightly opaque crystals or as a white, crystalline powder. It has a pleasant, acid taste. It is obtained as a byproduct of wine manufacture.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), P. 238, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an anticaking agent as defined in § 170.3(o)(1) of this chapter; an antimicrobial agent as defined in § 170.3(o)(2) of this chapter; a formulation aid as defined in § 170.3(o)(14) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; A pH control agent as defined in § 170.3(o)(23) of this chapter; a processing aid as defined in § 170.3(o)(24) of this chapter; a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and a surface-active agent as defined in § 170.3(o)(29) of this chapter.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; confections and frostings as defined in § 170.3(n)(9) of this chapter; gelatins and puddings as defined in § 170.3(n)(22) of this chapter; hard candy as defined in § 170.3(n)(25) of this chapter; jams and jellies as defined in § 170.3(n)(28) of this chapter; and soft candy as defined in § 170.3(n)(38) of this chapter.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1081 Propionic acid.

(a) Propionic acid (C 3 H 6 O 2 , CAS Reg. No. 79-09-4) is an oily liquid having a slightly pungent, rancid odor. It is manufactured by chemical synthesis or by bacterial fermentation.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 254, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter and a flavoring agent as defined in § 170.3(o)(12) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1090 Stearic acid.

(a) Stearic acid (C 18 H 36 O 2 , CAS Reg. No. 57-11-4) is a white to yellowish white solid. It occurs naturally as a glyceride in tallow and other animal or vegetable fats and oils and is a principal constituent of most commercially hydrogenated fats. It is produced commercially from hydrolyzed tallow derived from edible sources or from hydrolyzed, completely hydrogenated vegetable oil derived from edible sources.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and the requirements of § 172.860(b)(2) of this chapter. Copies of the Food Chemicals Codex are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1091 Succinic acid.

(a) Succinic acid (C 4 H 6 O 4 , CAS Reg. No. 110-15-6), also referred to as amber acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic acid. It is commercially prepared by hydrogenation of maleic or fumaric acid. It can also be produced by aqueous alkali or acid hydrolysis of succinonitrile.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 314-315, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter and pH control agent as defined in § 170.3(o)(23) of this chapter.

(d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.084 percent in condiments and relishes as defined in § 170.3(n)(8) of this chapter and 0.0061 percent in meat products as defined in § 170.3(n)(29) of this chapter.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1095 Sulfuric acid.

(a) Sulfuric acid (H 2 SO 4 , CAS Reg. No. 7664-93-9), also known as oil of vitriol, is a clear, colorless, oily liquid. It is prepared by reacting sulfur dioxide (SO 2 ) with oxygen and mixing the resultant sulfur trioxide (SO 3 ) with water, or by reacting nitric oxide (NO) with sulfur dioxide and water.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 317-318, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a pH control agent as defined in § 170.3(o)(23) of this chapter and processing aid as defined in § 170.3(o)(24) of this chapter.

(d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.014 percent for alcoholic beverages as defined in § 170.3(n)(2) of this chapter and 0.0003 percent for cheeses as defined in § 170.3(n)(5) of this chapter.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1097 Tannic acid.

(a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable gallotannin, is a complex polyphenolic organic structure that yields gallic acid and either glucose or quinic acid as hydrolysis products. It is a yellowish-white to light brown substance in the form of an amorphous, bulky powder, glistening scales, or spongy masses. It is also ordorless, or has a faint characteristic odor, and has an astringent taste. Tannic acid is obtained by solvent extraction of nutgalls or excrescences that form on the young twigs of Quercus infectoria Oliver and related species of Quercus. Tannic acid is also obtained by solvent extraction of the seed pods of Tara ( Caesalpinia spinosa ) or the nutgalls of various sumac species, including Rhus semialata, R. coriaria, R. galabra, and R. typhia.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 319, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c)(1) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

Category of food

Maximum level of use in food (as served) (percent)

Functional use

Baked goods and baking mixes, § 170.3(n)(1) of this chapter

0.01

Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter.

Alcoholic beverages, § 170.3(n)(2) of this chapter

0.015

Flavor enhancer, § 170.3(o)(11) of this chapter; flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; processing aid, § 170.3(o)(24) of this chapter.

Nonalcoholic beverages and beverage bases, § 170.3(n)(3) of this chapter and for gelatins, puddings, and fillings, § 170.3(n)(22) of this chapter

0.005

Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter; pH control agent, § 170.3(o)(23) of this chapter.

Frozen dairy desserts and mixes, § 170.3(n)(20) of this chapter and for soft candy, § 170.3(n)(38) of this chapter

0.04

Flavoring agent and adjuvant, § 170.3(o)(12) of this chapter.

Hard candy and cough drops, § 170.3(n)(25) of this chapter

0.013

Do.

Meat products, § 170.3(n)(29) of this chapter

0.001

Do.

(2) Tannic acid may be used in rendered animal fat in accordance with 9 CFR 424.21.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1099 Tartaric acid.

(a) Food grade tartaric acid (C 4 H 6 O 6 , CAS Reg. No. 87-69-4) has the l configuration. The l form of tartaric acid is dextrorotatory in solution and is also known as l−(+)−tartaric acid. Tartaric acid occurs as colorless or translucent crystals or as a white, crystalline powder. It is odorless and has an acid taste. It is obtained as a byproduct of wine manufacture.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), P. 320, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a firming agent as defined in § 170.3(o)(10) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a flavoring agent as defined in § 170.3(o)(12) of this chapter; a humectant as defined in § 170.3(o)(16) of this chapter; and a pH control agent as defined in § 170.3(o)(23) of this chapter.

(2) The ingredient is used in foods at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.

(a) Diacetyl tartaric acid esters of mono- and diglycerides, also known as DATEM, are composed of mixed esters of glycerin in which one or more of the hydroxyl groups of glycerin has been esterified by diacetyl tartaric acid and by fatty acids. The ingredient is prepared by the reaction of diacetyl tartaric anhydride with mono- and diglycerides that are derived from edible sources.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the National Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used in food as an emulsifier and emulsifier salt as defined in § 170.3(o)(8) of this chapter and a flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in § 170.3(n)(l) of this chapter; nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; confections and frostings as defined in § 170.3(n)(9) of this chapter; dairy product analogs as defined in § 170.3(n)(10) of this chapter; and fats and oils as defined in § 170.3(n)(12) of this chapter.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

(e) Labeling: The acronym “DATEM” may be used on food labeling as the alternate common or usual name for the ingredient diacetyl tartaric acid esters of mono- and diglycerides.

§ 184.1115 Agar-agar.

(a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic, colloidal polysaccharide extracted from one of a number of related species of red algae (class Rhodophyceae ).

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 11, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used in food in accordance with § 184.1(b)(2) under the following conditions:

Maximum Usage Levels Permitted

Foods (as served)

Percent

Functions

Baked goods and baking mixes, § 170.3(n)(1) of this chapter

0.8

Drying agent, § 170.3(o)(7) of this chapter; flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

Confections and frostings, § 170.3(n)(9) of this chapter

2.0

Flavoring agent, § 170.3(o)(12) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter; surface finisher, § 170.3(o)(30) of this chapter.

Soft candy, § 170.3(n)(38) of this chapter

1.2

Stabilizer and thickener, § 170.3(o)(28) of this chapter.

All other food categories

.25

Flavoring agent, § 170.3(o)(12) of this chapter; formulation aid, § 170.3(o)(14) of this chapter; humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1120 Brown algae.

(a) Brown algae are seaweeds of the species Analipus japonicus, Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica, Laminaria longicruris, Laminaria longissima, Laminaria ochotensis, Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia, Scytosiphon lomentaria and Undaria pinnatifida. They are harvested principally in coastal waters of the northern Atlantic and Pacific oceans. The material is dried and ground or chopped for use in food.

(b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

Category of food

Maximum level of use in food (as served)

Functional use

Spices, seasonings, and flavorings, § 170.3(n)(26) of this chapter

Not to exceed current good manufacturing practice

Flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter.

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.

§ 184.1121 Red algae.

(a) Red algae are seaweeds of the species Gloiopeltis furcata, Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and Rhodymenia are harvested principally along the coasts of Japan, Korea, China, Taiwan, and the East and West coasts of the United States. Gloiopeltis is harvested principally in southern Pacific coastal waters. The material is dried and ground or chopped for use in food.

(b) The ingredient meets the specifications for kelp in the Food Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by reference, except that the loss on drying is not more than 20 percent and the maximum allowable level for iodine is 0.05 percent. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

Category of food

Maximum level of use in food (as served)

Functional use

Spices, seasonings, and flavorings, § 170.3(n)(26) of this chapter

Not to exceed current good manufacturing practice

Flavor enhancer, § 170.3(o)(11) of this chapter; flavor adjuvant, § 170.3(o)(12) of this chapter.

(d) Prior sanctions for this ingredient different from the use established in this section do not exist or have been waived.

§ 184.1133 Ammonium alginate.

(a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Ammonium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 18, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

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, thickener, § 170.3(o)(28) of this chapter.

Fats and oils, § 170.3(n)(12) of this chapter

0.5

Do.

Gelatins, puddings, § 170.3(n)(22) of this chapter

0.5

Do.

Gravies and sauces, § 170.3(n)(24) of this chapter

0.4

Do.

Jams and jellies, § 170.3(n)(28) of this chapter

0.4

Do.

Sweet sauces, § 170.3(n)(43) of this chapter

0.5

Do.

All other food categories

0.1

Humectant, § 170.3(o)(16) of this chapter; stabilizer, thickener, § 170.3(o)(28) of this chapter.

(d) Prior sanctions for ammonium alginate different from the uses established in this section do not exist or have been waived.

§ 184.1135 Ammonium bicarbonate.

(a) Ammonium bicarbonate (NH 4 HCO 3 , CAS Reg. No. 1066-33-7) is prepared by reacting gaseous carbon dioxide with aqueous ammonia. Crystals of ammonium bicarbonate are precipitated from solution and subsequently washed and dried.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; and a texturizer as defined in § 170.3(o)(32) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1137 Ammonium carbonate.

(a) Ammonium carbonate ((NH 4 ) 2 CO 3 , CAS Reg. No. 8000-73-5) is a mixture of ammonium bicarbonate (NH 4 HCO 3 ) and ammonium carbamate (NH 2 COONH 4 ). It is prepared by the sublimation of a mixture of ammonium sulfate and calcium carbonate and occurs as a white powder or a hard, white or translucent mass.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 19, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a leavening agent as defined in § 170.3(o)(17) of this chapter and a pH control agent as defined in § 170.3(o)(23) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1138 Ammonium chloride.

(a) Ammonium chloride (NH 4 Cl, CAS Reg. No. 12125-02-9) is produced by the reaction of sodium chloride and an ammonium salt in solution. The less soluble sodium salt separates out at elevated temperatures, and ammonium chloride is recovered from the filtrate on cooling. Alternatively, hydrogen chloride formed by the burning of hydrogen in chlorine is dissolved in water and then reacted with gaseous ammonia. Ammonium chloride is crystallized from the solution.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave, NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter; a flavor enhancer as defined in § 170.3(o)(11) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; and a processing aid as defined in § 107.3(o)(24) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1139 Ammonium hydroxide.

(a) Ammonium hydroxide (NH 4 OH, CAS Reg. No. 1336-21-6) is produced by passing ammonia gas into water.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 20, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a leavening agent as defined in § 170.3(o)(17) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; a surface-finishing agent as defined in § 170.3(o)(30) of this chapter; and as a boiler water additive complying with § 173.310 of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. The ingredient may also be used as a boiler water additive at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1140 Ammonium citrate, dibasic.

(a) Ammonium citrate, dibasic ((NH 4 ) 2 HC 6 H 5 O 7 , CAS Reg. No. 3012-65-5) is the diammonium salt of citric acid. It is prepared by partially neutralizing citric acid with ammonia.

(b) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter and as a pH control agent as defined in § 170.3(o)(23) of this chapter.

(2) The ingredient is used in nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter and in cheeses as defined in § 170.3(n)(5) of this chapter at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section, or different from those set forth in part 181 of this chapter, do not exist or have been waived.

§ 184.1141a Ammonium phosphate, monobasic.

(a) Ammonium phosphate, monobasic (NH 4 H 2 PO 4 , CAS Reg. No. 7722-76-1) is manufactured by reacting ammonia with phosphoric acid at a pH below 5.8.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter and a pH control agent as defined in § 170.3(o)(23) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1141b Ammonium phosphate, dibasic.

(a) Ammonium phosphate, dibasic ((NH 4 ) 2 HPO 4 , CAS Reg. No. 7783-28-0) is manufactured by reacting ammonia with phosphoric acid at a pH above 5.8.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 21, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter; a firming agent as defined in § 170.3(o)(10) of this chapter; a leavening agent as defined in § 170.3(o)(17) of this chapter; a pH control agent as defined in § 170.3(o)(23) of this chapter; and a processing aid as defined in § 170.3(o)(24) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1143 Ammonium sulfate.

(a) Ammonium sulfate ((NH 4 ) 2 SO 4 , CAS Reg. No. 7783-20-2) occurs naturally and consists of colorless or white, odorless crystals or granules. It is prepared by the neutralization of sulfuric acid with ammonium hydroxide.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 22-23, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter, firming agent as defined in § 170.3(o)(10) of this chapter, and processing aid as defined in § 170.3(o)(24) of this chapter.

(d) The ingredient is used in food at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 0.15 percent for baked goods as defined in § 170.3(n)(1) of this chapter and 0.1 percent for gelatins and puddings as defined in § 170.3(n)(22) of this chapter.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1148 Bacterially-derived carbohydrase enzyme preparation.

(a) Bacterially-derived carbohydrase enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes α-amylase (EC 3.2.1.1) and β-glucanase (EC 3.2.1.6), which catalyze the hydrolysis of O -glycosyl bonds in carbohydrates.

(b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze polysaccharides (e.g., starch).

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

§ 184.1150 Bacterially-derived protease enzyme preparation.

(a) Bacterially-derived protease enzyme preparation is obtained from the culture filtrate resulting from a pure culture fermentation of a nonpathogenic and nontoxigenic strain of Bacillus subtilis or B. amyloliquefaciens. The preparation is characterized by the presence of the enzymes subtilisin (EC 3.4.21.62) and neutral proteinase (EC 3.4.24.28), which catalyze the hydrolysis of peptide bonds in proteins.

(b) The ingredient meets the general requirements and additional requirements in the monograph on enzyme preparations in the Food Chemicals Codex, 4th ed. (1996), pp. 128-135, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In addition, antibiotic activity is absent in the enzyme preparation when determined by an appropriate validated method such as the method “Determination of antibiotic activity” in the Compendium of Food Additive Specifications, vol. 2, Joint FAO/WHO Expert Committee on Food Additives (JECFA), Food and Agriculture Organization of the United Nations, Rome, 1992. Copies are available from Bernan Associates, 4611-F Assembly Dr., Lanham, MD 20706, or from The United Nations Bookshop, General Assembly Bldg., rm. 32, New York, NY 10017, or by inquiries sent to http://www.fao.org. Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, 5001 Campus Dr., College Park, MD 20740.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as GRAS as a direct food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as an enzyme as defined in § 170.3(o)(9) of this chapter to hydrolyze proteins or polypeptides.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice.

§ 184.1155 Bentonite.

(a) Bentonite (Al 2 O 3 4SiO 2 nH 2 O, CAS Reg. No. 1302-78-9) is principally a colloidal hydrated aluminum silicate. Bentonite contains varying quantities of iron, alkalies, and alkaline earths in the commercial products. Depending on the cations present, natural deposits of bentonite range in color from white to gray, yellow, green, or blue. Bentonite's fine particles provide large total surface area and, hence, pronounced adsorptive capability.

(b) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a processing aid as defined in § 170.3(o)(24) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice results in no significant residue in foods.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1157 Benzoyl peroxide.

(a) Benzoyl peroxide ((C 6 H 5 CO) 2 O 2 , CAS Reg. No. 94-36-0) is a colorless, rhombic crystalline solid. It is prepared by reaction of benzoyl chloride, sodium hydroxide, and hydrogen peroxide.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 35, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a bleaching agent in food.

(2) The ingredient is used in the following foods at levels not to exceed current good manufacturing practice: flour; milk used for production of Asiago fresh and Asiago soft cheese (§ 133.102), Asiago medium cheese (§ 133.103), Asiago old cheese (§ 133.104), Blue cheese (§ 133.106), Caciocavallo siciliano chesse (§ 133.111), Gorgonzola cheese (§ 133.141), Parmesan and reggiano cheese (§ 133.165), Provolone cheese (§ 133.181), Romano cheese (§ 133.183), and Swiss and emmentaler cheese (§ 133.195) in part 133 of this chapter; and annatto-colored whey, such that the final bleached product conforms to the descriptions and specifications for whey, concentrated whey, or dried whey in § 184.1979(a)(1), (2), or (3), respectively.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1165 n-Butane and iso-butane.

(a) n-Butane and iso-butane (empirical formula C 4 H 10 , CAS Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, flammable gases at normal temperatures and pressures. They are easily liquefied under pressure at room temperature and are stored and shipped in the liquid state. The butanes are obtained from natural gas by fractionation following absorption in oil, adsorption to surface-active agents, or refrigeration.

(b) The ingredients must be of a purity suitable for their intended use.

(c) In accordance with § 184.1(b)(1), these ingredients are used in food with no limitations other than current good manufacturing practice. The affirmation of these ingredients as generally recognized as safe (GRAS) as direct human food ingredients is based upon the following current good manufacturing practice conditions of use:

(1) The ingredients are used as propellants, aerating agents, and gases as defined in § 170.3(o)(25) of this chapter.

(2) The ingredients are used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.

§ 184.1185 Calcium acetate.

(a) Calcium acetate (Ca (C 2 H 3 O 2 ) 2 , CAS Reg. No. 62-54-4), also known as acetate of lime or vinegar salts, is the calcium salt of acetic acid. It may be produced by the calcium hydroxide neutralization of acetic acid.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 44, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a firming agent as defined in § 170.3(o)(10) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) of this chapter; sequestrant as defined in § 170.3(o)(26) of this chapter; stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter.

(d) The ingredient is used in food at levels not to exceed current good manufacturing practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.2 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.02 percent for cheese as defined in § 170.3(n)(5) of this chapter; 0.2 percent for gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; 0.15 percent for sweet sauces, toppings, and syrups as defined in § 170.3(n)(43) of this chapter; and 0.0001 percent for all other food categories.

(e) Prior sanctions for this ingredient different from the uses established in this section or in part 181 of this chapter do not exist or have been waived.

§ 184.1187 Calcium alginate.

(a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of alginic acid, a natural polyuronide constituent of certain brown algae. Calcium alginate is prepared by the neutralization of purified alginic acid with appropriate pH control agents, or from sodium alginate by metathesis with appropriate calcium salts.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 45, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(2), the ingredient is used in food only within the following specific limitations:

Category of food

Maximum level of use in food (as served) (percent)

Functional use

Baked goods, § 170.3(n)(1) of this chapter

0.002

Stabilizer, thickener, § 170.3(o)(28) of this chapter.

Alcoholic beverages, § 170.3(n)(2) of this chapter

0.4

Do.

Confections and frostings, § 170.3(n)(9) of this chapter

0.4

Do.

Egg products, § 170.3(n)(11) of this chapter

0.6

Do.

Fats and oils, § 170.3(n)(12) of this chapter

0.5

Do.

Gelatins, puddings, § 170.3(n)(22) of this chapter

0.25

Do.

Gravies and sauces, § 170.3(n)(24) of this chapter

0.4

Do.

Jams and jellies, § 170.3(n)(28) of this chapter

0.5

Do.

Sweet sauces, § 170.3(n)(43) of this chapter

0.5

Do.

All other food categories

0.3

Do.

(d) Prior sanctions for calcium alginate different from the uses established in this section do not exist or have been waived.

§ 184.1191 Calcium carbonate.

(a) Calcium carbonate (CaCO 3 , CAS Reg. No. 471-34-1) is prepared by three common methods of manufacture:

(1) As a byproduct in the “Lime soda process”;

(2) By precipitation of calcium carbonate from calcium hydroxide in the “Carbonation process”; or

(3) By precipitation of calcium carbonate from calcium chloride in the “Calcium chloride process”.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 46, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section, or different from that set forth in part 181 of this chapter, do not exist or have been waived.

§ 184.1193 Calcium chloride.

(a) Calcium chloride (CaCl 2 ·2H 2 O, CAS Reg. No. 10035-04-8) or anhydrous calcium chloride (CaCl 2 , CAS Reg. No. 10043-52-4) may be commercially obtained as a byproduct in the ammonia-soda (Solvay) process and as a joint product from natural salt brines, or it may be prepared by substitution reactions with other calcium and chloride salts.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 47, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as an anticaking agent as defined in § 170.3(o)(1) of this chapter; antimicrobial agent as defined in § 170.3(o)(2) of this chapter; curing or pickling agent as defined in § 170.3(o)(5) of this chapter; firming agent as defined in § 170.3(o)(10) of this chapter; flavor enhancer as defined in § 170.3(o)(11) of this chapter; humectant as defined in § 170.3(o)(16) of this chapter; nutrient supplement as defined in § 170.3(o)(20) of this chapter; pH control agent as defined in § 170.3(o)(23) of this chapter; processing aid as defined in § 170.3(o)(24) of this chapter; stabilizer and thickener as defined in § 170.3(o)(28) of this chapter; surface-active agent as defined in § 170.3(o)(29) of this chapter; synergist as defined in § 170.3(o)(31) of this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter.

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 0.3 percent for baked goods as defined in § 170.3(n)(1) of this chapter and for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 0.22 percent for nonalcoholic beverages and beverage bases as defined in § 170.3(n)(3) of this chapter; 0.2 percent for cheese as defined in § 170.3(n)(5) of this chapter and for processed fruit and fruit juices as defined in § 170.3(n)(35) of this chapter; 0.32 percent for coffee and tea as defined in § 170.3(n)(7) of this chapter; 0.4 percent for condiments and relishes as defined in § 170.3(n)(8) of this chapter; 0.2 percent for gravies and sauces as defined in § 170.3(n)(24) of this chapter; 0.1 percent for commercial jams and jellies as defined in § 170.3(n)(28) of this chapter; 0.25 percent for meat products as defined in § 170.3(n)(29) of this chapter; 2.0 percent for plant protein products as defined in § 170.3(n)(33) of this chapter; 0.4 percent for processed vegetables and vegetable juices as defined in § 170.3(n)(36) of this chapter; and 0.05 percent for all other food categories.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1195 Calcium citrate.

(a) Calcium citrate (Ca 3 (C 6 H 5 O 7 ) 2 ·4H 2 O, CAS Reg. No. 813-0994-095) is the calcium salt of citric acid. It is prepared by neutralizing citric acid with calcium hydroxide or calcium carbonate. It occurs as a fine white, odorless powder and usually contains four moles of water per mole of calcium citrate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and the Center for Food Safety and Applied Nutrition (HFS-200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. Calcium citrate may also be used in infant formula in accordance with section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with regulations promulgated under section 412(a)(2) of the act.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1199 Calcium gluconate.

(a) Calcium gluconate ([CH 2 OH(CHOH) 4 COO] 2 Ca, CAS Reg. No. 299-28-5) is the calcium salt of gluconic acid which may be produced by neutralization of gluconic acid with lime or calcium carbonate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 51, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a firming agent as defined in § 170.3(o)(10) of this chapter; formulation aid as defined in § 170.3(o)(14) of this chapter; sequestrant as defined in § 170.3(o)(26) of this chapter; stabilizer or thickener as defined in § 170.3(o)(28) of this chapter; and texturizer as defined in § 170.3(o)(32) of this chapter.

(d) The ingredient is used in foods at levels not to exceed current good manufacturing practices in accordance with § 184.1(b)(1). Current good manufacturing practices result in a maximum level, as served, of 1.75 percent for baked goods as defined in § 170.3(n)(1) of this chapter; 0.4 percent for dairy product analogs as defined in § 170.3(n)(10) of this chapter; 4.5 percent for gelatins and puddings as defined in § 170.3(n)(22) of this chapter; and 0.01 percent for sugar substitutes as defined in § 170.3(n)(42) of this chapter.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1201 Calcium glycerophosphate.

(a) Calcium glycerophosphate (C 3 H 7 CaO 6 P, CAS Reg. No. 27214-00-2) is a fine, white, odorless, almost tasteless, slightly hygroscopic powder. It is prepared by neutralizing glycerophosphoric acid with calcium hydroxide or calcium carbonate. The commercial product is a mixture of calcium β-, and D-, and L -α-glycerophosphate.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 51-52, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a nutrient supplement as defined in § 170.3(o)(20) of this chapter.

(2) The ingredient is used in gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter.

(d) Prior sanctions for this ingredient different from the uses established in this section or different from that as set forth in part 181 of this chapter, do not exist or have been waived.

§ 184.1205 Calcium hydroxide.

(a) Calcium hydroxide (Ca(OH) 2 , CAS Reg. No. 1305-62-0) is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), p. 52, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

§ 184.1206 Calcium iodate.

(a) Calcium iodate [Ca(IO 3 ) 2 ·H 2 O, CAS Reg. No. 7789-80-2], also referred to as lautarite, does not occur naturally but can be prepared by passing chlorine into a hot solution of lime (CaCO 3 ) in which iodine has been dissolved.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 53, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as a dough strengthener as defined in § 170.3(o)(6) of this chapter.

(d) The ingredient is used in the manufacture of bread in accordance with § 184.1(b)(2) of this chapter in an amount not to exceed 0.0075 percent based on the weight of the flour.

(e) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.