Title 21 CFR reference

Modified polyacrylamide resin may be safely used in food in accordance with the following prescribed conditions: (a) The modified polyacrylamide resin is produced by the copolymerization of acrylamide with not more than 5-mole percent β-methacrylyloxyethy-ltrimethylammonium methyl sulfate. (b) The modified polyacrylamide resin contains not more than 0.05 percent residual acrylamide. (c) The modified polyacrylamide resin is used as a flocculent in the clarification of beet or cane sugar juice in an amount not exceeding 5 parts per million by weight of the juice. (d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to the other information required by the act, adequate directions to assure use in compliance with paragraph (c) of this section.

Rhizopus niveus,Amyloglucosidase enzyme product, consisting of enzyme derived from and diatomaceous silica as a carrier, may be safely used in food in accordance with the following conditions: Rhizopus niveusRhizopus;niveus.(a) is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, species, Rhizopus niveus(b) The strain of is nonpathogenic and nontoxic in man or other animals. Rhizopus niveus(c) The enzyme is produced by a process which completely removes the organism from the amyloglucosidase. (d) The additive is used or intended for use for degrading gelatinized starch into constituent sugars, in the production of distilled spirits and vinegar. (e) The additive is used at a level not to exceed 0.1 percent by weight of the gelatinized starch.

The food additive alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation, may be safely used in accordance with the following conditions: Bacillus subtilisBacillus brevis.(a) The food additive is the enzyme preparation derived from a modified strain that contains the gene coding for α-ALDC from Bacillus subtilis(b)(1) The manufacturer produces the additive from a pure culture fermentation of a strain of that is nonpathogenic and nontoxigenic in man or other animals. (2) The manufacturer may stabilize the enzyme preparation with glutaraldehyde or with other suitable approved food additives or generally recognized as safe substances. Food Chemicals Codex,http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(3) The enzyme preparation must meet the general and additional requirements for enzyme preparations in the 4th ed., 1996, pp. 133-134, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation 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 20055, or may be…

Aspergillus nigerCarbohydrase and cellulase enzyme preparation derived from may be safely used in food in accordance with the following prescribed conditions: Aspergillus nigerAspergillus;niger.(a) is classified as follows: Class, Deuteromycetes; order, Moniliales; family, Moniliaceae; genus, species, Aspergillus niger(b) The strain of is nonpathogenic and nontoxic in man or other animals. Aspergillus niger(c) The additive is produced by a process that completely removes the organism from the carbohydrase and cellulase enzyme product. (d) The additive is used or intended for use as follows: (1) For removal of visceral mass (bellies) in clam processing. (2) As an aid in the removal of the shell from the edible tissue in shrimp processing. (e) The additive is used in an amount not in excess of the minimum required to produce its intended effect.

Rhizopus oryzaeCarbohydrase from may be safely used in the production of dextrose from starch in accordance with the following prescribed conditions: Rhizopus oryzaeRhizopus;Rhizopus oryzae.(a) is classified as follows: Class, Phycomycetes; order, Mucorales; family, Mucoraceae; genus, species, Rhizopus oryzae(b) The strain of is nonpathogenic and nontoxic. (c) The carbohydrase is produced under controlled conditions to maintain nonpathogenicity and nontoxicity, including the absence of aflatoxin. Rhizopus oryzae(d) The carbohydrase is produced by a process which completely removes the organism from the carbohydrase product. (e) The carbohydrase is maintained under refrigeration from production to use and is labeled to include the necessity of refrigerated storage.

Micrococcus lysodeikticusBacterial catalase derived from by a pure culture fermentation process may be safely used in destroying and removing hydrogen peroxide used in the manufacture of cheese, in accordance with the following conditions. Micrococcus lysodeikticus(a) The organism from which the bacterial catalase is to be derived is demonstrated to be nontoxic and nonpathogenic. Micrococcus lysodeikticus(b) The organism is removed from the bacterial catalase prior to use of the bacterial catalase. (c) The bacterial catalase is used in an amount not in excess of the minimum required to produce its intended effect.

Mucor mieheiCooney et EmersonEsterase-lipase enzyme, consisting of enzyme derived from var. by a pure culture fermentation process, with maltodextrin or sweet whey as a carrier, may be safely used in food in accordance with the following conditions: Mucor mieheiCooney et EmersonMucor;miehei;Cooney et Emerson.(a) var. is classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, species, variety Mucor mieheiCooney et Emerson(b) The strain of var. is nonpathogenic and nontoxic in man or other animals. Mucor mieheiCooney et Emerson(c) The enzyme is produced by a process which completely removes the organism var. from the esterase-lipase. (d) The enzyme is used as a flavor enhancer as defined in § 170.3(o)(12). (e) The enzyme is used at levels not to exceed current good manufacturing practice in the following food categories: cheeses as defined in § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chapter; and milk products as defined in § 170.(3)(n)(31) of this chapter. Use of this food ingredient is limited to nonstandarized foods and those foods for which the relevant standards of identity…

Mortierella vinaceaeraffinoseutilizerThe food additive alpha-galactosidase and parent mycelial microorganism var. may be safely used in food in accordance with the following conditions: Mortierella vinaceaeraffinoseutilizer(a) The food additive is the enzyme alpha-galactosidase and the mycelia of the microorganism var. which produces the enzyme. 1(b) The nonpathogenic microorganism matches American Type Culture Collection (ATCC) No. 20034, and is classified as follows: (c) The additive is used or intended for use in the production of sugar (sucrose) from sugar beets by addition as mycelial pellets to the molasses to increase the yield of sucrose, followed by removal of the spent mycelial pellets by filtration. (d) The enzyme removal is such that there are no enzyme or mycelial residues remaining in the finished sucrose. 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852. [42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989]

Milk-clotting enzyme produced by pure-culture fermentation process may be safely used in the production of cheese in accordance with the following prescribed conditions: (a) Milk-clotting enzyme is derived from one of the following organisms by a pure-culture fermentation process: Endothia parasiticaEndothia;parasitica.(1) classified as follows: Class, Ascomycetes; order, Sphaeriales; family, Diaporthacesae; genus, species, Bacillus cereusBacillus;cereus(2) classified as follows: Class, Schizomycetes; order, Eubacteriales; family, Bacillaceae; genus, species, (Frankland and Frankland). Mucor pusillusMucor;pusillus;Lindt.(3) Lindt classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, species, variety, Mucor miehei Cooney et EmersonMucor;miehei;Cooney et Emerson.(4) classified as follows: Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, species, variety, Aspergillus oryzaeRhizomucor mieheiCooney et EmersonAspergillusoryzae.(5) modified by recombinant deoxyribonucleic (DNA) techniques to contain the gene coding for aspartic proteinase from var. as defined in paragraph (a)(4) of…

Candida guilliermondiiThe food additive may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions: Candida guilliermondii(a) The food additive is the enzyme system of the viable organism and its concomitant metabolites produced during the fermentation process. 1(b)(1) The nonpathogenic and nontoxicogenic organism descending from strain, American Type Culture Collection (ATCC) No. 20474, is classified as follows: Candida guilliermondiiguilliermondiihttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) The toxonomic characteristics of the reference culture strain ATCC No. 20474 agree in the essentials with the standard description for variety listed in “The Yeasts—A Toxonomic Study;” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of…

Candida lipolyticaThe food additive may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions: Candida lipolytica(a) The food additive is the enzyme system of the organism and its concimitant metabolites produced during the fermentation process. (b)(1) The nonpathogenic organism is classified as follows: Candida lipolyticalipolyticahttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) The taxonomic characteristics of the culture agree in essential with the standard description for variety listed in “The Yeasts—A Toxonomic Study,” 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: (c) The additive is used or intended for use as a pure culture in the fermentation process for the…

The food additive aminoglycoside 3′-phosphotransferase II may be safely used in the development of genetically modified cotton, oilseed rape, and tomatoes in accordance with the following prescribed conditions: (a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin. kanEscherichia coli.r553(b) Aminoglycoside 3′-phosphotransferase II is encoded by the gene originally isolated from transposon Tn of the bacterium kanr(c) The level of the additive does not exceed the amount reasonably required for selection of plant cells carrying the gene along with the genetic material of interest. [59 FR 26711, May 23, 1994]

Ion-exchange membranes may be safely used in the processing of food under the following prescribed conditions: (a) The ion-exchange membrane is prepared by subjecting a polyethylene base conforming to § 177.1520 of this chapter to polymerization with styrene until the polystyrene phase of the base is not less than 16 percent nor more than 30 percent by weight. The base is then modified by reaction with chloromethyl methyl ether, and by subsequent amination with trimethylamine, dimethylamine, diethylenetriamine, or dimethylethanolamine. (b) The ion-exchange membrane is manufactured so as to comply with the following extraction limitations when subjected to the described procedure: Separate square-foot samples of membrane weighing approximately 14 grams each are cut into small pieces and refluxed for 4 hours in 150 cubic centimeters of the following solvents: Distilled water, 5 percent acetic acid, and 50 percent alcohol. Extraction from each sample will not exceed 0.4 percent by weight of sample. (c) The ion-exchange membrane will be used in the production of grapefruit juice to adjust the ratio of citric acid to total solids of the grapefruit juice produced.

Substances identified in paragraph (a) of this section may be safely used as ion exchange membranes intended for use in the treatment of bulk quantities of liquid food under the following prescribed conditions: Identity.(a) The membrane is a copolymer of ethanesulfonyl fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that has been subsequently treated to hydrolyze the sulfonyl fluoride group to the sulfonic acid. The Chemical Abstracts Service name of this polymer is ethanesulfonic acid, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9). Optional adjuvant substances.(b) The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymer. These optional adjuvant substances may include substances used in accordance with § 174.5 of this chapter. Conditions of use.(c) (1) Perfluorinated ion exchange membranes described in paragraph (a) of this section may be used in contact with all types of liquid foods at…

A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice.

1,3-Butylene glycol (1,3-butanediol) may be safely used in food in accordance with the following prescribed conditions: (a) The substance meets the following specifications: (1) 1,3-Butylene glycol content: Not less than 99 percent. (2) Specific gravity at 20/20 °C: 1.004 to 1.006. (3) Distillation range: 200°-215 °C. (b) It is used in the minimum amount required to perform its intended effect. (c) It is used as a solvent for natural and synthetic flavoring substances except where standards of identity issued under section 401 of the act preclude such use.

Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in accordance with the following conditions: http://www.usp.orghttp://www.archives.gov/federal-register/cfr/ibr-locations.html.(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 343-344, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address ). Copies 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: (b) The additive is used in accordance with current good manufacturing practice as a solvent in the decaffeination of coffee and tea. [47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984; 78 FR 71466, Nov. 29,…

Provided, however,A tolerance of 30 parts per million is established for ethylene dichloride in spice oleoresins when present therein as a residue from the extraction of spice; That if residues of other chlorinated solvents are also present the total of all residues of such solvents shall not exceed 30 parts per million.

Isopropyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. (b) In lemon oil as a residue in production of the oil, at a level not to exceed 6 parts per million. Provided,(c) In hops extract as a residue from the extraction of hops at a level not to exceed 2.0 percent by weight: That, (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the isopropyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (c)(1) of this section.

Ion-exchange resins may be safely used in the treatment of food under the following prescribed conditions: (a) The ion-exchange resins are prepared in appropriate physical form, and consist of one or more of the following: (1) Sulfonated copolymer of styrene and divinylbenzene. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) Sulfonated anthracite coal meeting the requirements of ASTM method D388-38, Class I, Group 2, “Standard Specifications for Classification of Coal by Rank,” which is incorporated by reference. Copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, 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: (3) Sulfite-modified cross-linked phenol-formaldehyde, with modification resulting in sulfonic acid groups on side chains. (4) Methacrylic acid-divinylbenzene copolymer. (5) Cross-linked polystyrene, first chloromethylated then aminated with trimethylamine, dimethylamine, di-ethylenetriamine, or dimethylethanol-amine. (6) Diethylenetriamine,…

Methyl alcohol may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 50 parts per million. Provided,(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of methyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

Methylene chloride may be present in food under the following conditions: Provided,(a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 30 parts per million; That, if residues of other chlorinated solvents are also present, the total of all residues of such solvents shall not exceed 30 parts per million. Provided,(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent, That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract identifies the presence of the methylene chloride and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section. (c) In coffee as a residue from its use as a solvent in the extraction of caffeine from green coffee beans, at a level not to exceed 10 parts per million (0.001 percent) in decaffeinated roasted coffee and in decaffeinated soluble coffee extract (instant coffee).

Hexane may be present in the following foods under the conditions specified: (a) In spice oleoresins as a residue from the extraction of spice, at a level not to exceed 25 parts per million. Provided,(b) In hops extract as a residue from the extraction of hops, at a level not to exceed 2.2 percent by weight; That: (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the hexane and provides for the use of the hops extract only as prescribed by paragraph (b)(1) of this section.

The food additive hydrogenated sperm oil may be safely used in accordance with the following prescribed conditions: (a) The sperm oil is derived from rendering the fatty tissue of the sperm whale or is prepared by synthesis of fatty acids and fatty alcohols derived from the sperm whale. The sperm oil obtained by rendering is refined. The oil is hydrogenated. (b) It is used alone or as a component of a release agent or lubricant in bakery pans. (c) The amount used does not exceed that reasonably required to accomplish the intended lubricating effect.

Aspergillus nigerA solvent extraction process for recovery of citric acid from conventional fermentation liquor may be safely used to produce food-grade citric acid in accordance with the following conditions: n-(a) The solvent used in the process consists of a mixture of octyl alcohol meeting the requirements of § 172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of § 172.882 of this chapter, and tridodecyl amine. (b) The component substances are used solely as a solvent mixture and in a manner that does not result in formation of products not present in conventionally produced citric acid. http://www.usp.orghttp://www.archives.gov/federal-register/cfr/ibr-locations.html.(c) The citric acid so produced meets the polynuclear aromatic hydrocarbon specifications of § 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,…

Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows: Table | Column 1 | Column 2 | | --- | --- | | Decaffeinated ground coffee | 25 parts per million. | | Decaffeinated soluble (instant) coffee extract | 10 parts per million. | | Spice oleoresins | 30 parts per million (provided that if residues of other chlorinated solvents are also present, the total of all residues of such solvents in spice oleoresins shall not exceed 30 parts per million). |

Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in food in accordance with the following prescribed conditions: (a)(1) The additive is generated by one of the following methods: (i) Treating an aqueous solution of sodium chlorite with either chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid. (ii) Treating an aqueous solution of sodium chlorate with hydrogen peroxide in the presence of sulfuric acid. (iii) Treating an aqueous solution of sodium chlorite by electrolysis. 252252http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) The generator effluent contains at least 90 percent (by weight) of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO E in the “Standard Methods for the Examination of Water and Wastewater,” 20th ed., 1998, or an equivalent method. Method 4500-ClO E (“Amperometric Method II”) is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy 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,…

Boiler water additives may be safely used in the preparation of steam that will contact food, under the following conditions: (a) The amount of additive is not in excess of that required for its functional purpose, and the amount of steam in contact with food does not exceed that required to produce the intended effect in or on the food. (b) The compounds are prepared from substances identified in paragraphs (c) and (d) of this section, and are subject to the limitations, if any, prescribed: (c) List of substances: (d) Substances used alone or in combination with substances in paragraph (c) of this section: (e) To assure safe use of the additive, in addition to the other information required by the Act, the label or labeling shall bear: (1) The common or chemical name or names of the additive or additives. (2) Adequate directions for use to assure compliance with all the provisions of this section. http://www.archives.gov/federal-register/cfr/ibr-locations.html.(f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at…

Chemicals may be safely used to wash or to assist in the peeling of fruits and vegetables in accordance with the following conditions: (a) The chemicals consist of one or more of the following: (1) Substances generally recognized as safe in food or covered by prior sanctions for use in washing fruits and vegetables. (2) Substances identified in this subparagraph and subject to such limitations as are provided: (3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-260) may be used in the steam/scald vacuum peeling of tomatoes at a level not to exceed 0.2 percent in the condensate or scald water. (4) Substances identified in this paragraph (a)(4) for use in flume water for washing sugar beets prior to the slicing operation and subject to the limitations as are provided for the level of the substances in the flume water: (5) Substances identified in this paragraph (a)(5) for use on fruits and vegetables that are not raw agricultural commodities and subject to the limitations provided: (b) The chemicals are used in amounts not in excess of the minimum required to accomplish their intended effect. (c) The use of the chemicals listed under paragraphs (a)(1), (a)(2),…

Agents for controlling microorganisms in cane-sugar and beet-sugar mills may be safely used in accordance with the following conditions: (a) They are used in the control of microorganisms in cane-sugar and/or beet-sugar mills as specified in paragraph (b) of this section. (b) They are applied to the sugar mill grinding, crusher, and/or diffuser systems in one of the combinations listed in paragraph (b)(1), (2), (3), or (5) of this section or as a single agent listed in paragraph (b)(4) or (6) of this section. Quantities of the individual additives in parts per million are expressed in terms of the weight of the raw cane or raw beets. (1) Combination for cane-sugar mills: (2) Combination for cane-sugar mills: (3) Combinations for cane-sugar mills and beet-sugar mills: (4) Single additive for cane-sugar mills and beet-sugar mills. (5) Combination for cane-sugar mills: (6) Single additive for beet-sugar mills: (c) To assure safe use of the additives, their label and labeling shall conform to that registered with the Environmental Protection Agency. Table | Parts per million | | --- | | Disodium cyanodithioimidocarbonate | 2.5 | | Ethylenediamine | 1 | | N-03Potassium…

Chemicals may be safely used to assist in the delinting of cottonseed in accordance with the following conditions: (a) The chemicals consist of one or more of the following: (1) Substances generally recognized as safe for direct addition to food. (2) Substances identified in this paragraph and subject to such limitations as are provided: Table | Substances | Limitations | | --- | --- | | alpha03omega03-Alkyl--hydroxypoly-(oxyethylene) produced by condensation of a linear primary alcohol containing an average chain length of 10 carbons with poly(oxyethylene) having an average of 5 ethylene oxide units | May be used at an application rate not to exceed 0.3 percent by weight of cottonseeds to enhance delinting of cottonseeds intended for the production of cottonseed oil. Byproducts including lint, hulls, and meal may be used in animal feed. | | An alkanomide produced by condensation of coconut oil fatty acids and diethanolamine, CAS Reg. No. 068603-42-9 | May be used at an application rate not to exceed 0.2 percent by weight of cottonseeds to enhance delinting of cottonseeds intended for the production of cottonseed oil. Byproducts including lint, hulls, and meal may be used in…

Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by mixing an aqueous solution of sodium chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe (GRAS) acid. (b)(1) The additive is used as an antimicrobial agent in poultry processing water in accordance with current industry practice under the following conditions: (i) As a component of a carcass spray or dip solution prior to immersion of the intact carcass in a prechiller or chiller tank; (ii) In a prechiller or chiller solution for application to the intact carcass; (iii) As a component of a spray or dip solution for application to poultry carcass parts; (iv) In a prechiller or chiller solution for application to poultry carcass parts; or (v) As a component of a post-chill carcass spray or dip solution when applied to poultry meat, organs, or related parts or trim. (2) When used in a spray or dip solution, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 parts per million (ppm), in combination with any GRAS acid at a level sufficient to achieve a solution pH of 2.3…

Defoaming agents may be safely used in processing foods, in accordance with the following conditions: (a) They consist of one or more of the following: (1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section. (2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed: (3) Substances listed in this paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed: (4) The substances listed in this paragraph (a)(4), provided they are components of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed: (b) They are added in an amount not in excess of that reasonably required to inhibit foaming. Table | Substances | Limitations | | --- | --- | | Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups; no more than 18 percent loss in weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 centistokes at 25 °C; refractive index 1.400-1.404 at 25 °C) | 10 parts per million in food, or…

A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon 113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No. 355-42-0) may be safely used in accordance with the following prescribed conditions: (a) The additive chlorofluorocarbon 113 has a purity of not less than 99.99 percent. (b) The additive mixture is intended for use to quickly cool or crust-freeze chickens sealed in intact bags composed of substances regulated in parts 174, 175, 177, 178, and § 179.45 of this chapter and conforming to any limitations or specifications in such regulations. [55 FR 8913, Mar. 9, 1990]

The food additive chloropentafluoroethane may be safely used in food in accordance with the following prescribed conditions: (a) The food additive has a purity of not less than 99.97 percent, and contains not more than 200 parts per million saturated fluoro compounds and 10 parts per million unsaturated fluoro compounds as impurities. (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, propane, and octafluorocyclobutane complying with § 173.360, as an aerating agent for foamed or sprayed food products, with any propellant effect being incidental and no more than is minimally necessary to achieve the aerating function, except that use is not permitted for those standardized foods that do not provide for such use. (c) To assure safe use of the additive (1) The label of the food additive container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, chloropentafluoroethane. (ii) The percentage of the additive present in the case of a mixture. (iii) The designation “food grade”. (2) The label or labeling of the food additive container…

The food additive combustion product gas may be safely used in the processing and packaging of the foods designated in paragraph (c) of this section for the purpose of removing and displacing oxygen in accordance with the following prescribed conditions: (a) The food additive is manufactured by the controlled combustion in air of butane, propane, or natural gas. The combustion equipment shall be provided with an absorption-type filter capable of removing possible toxic impurities, through which all gas used in the treatment of food shall pass; and with suitable controls to insure that any combustion products failing to meet the specifications provided in this section will be prevented from reaching the food being treated. (b) The food additive meets the following specifications: (1) Carbon monoxide content not to exceed 4.5 percent by volume. (2) The ultraviolet absorbance in isooctane solution in the range 255 millimicrons to 310 millimicrons not to exceed one-third of the standard reference absorbance when tested as described in paragraph (e) of this section. (c) It is used or intended for use to displace or remove oxygen in the processing, storage, or packaging of beverage…

The food additive dichlorodifluoromethane may be safely used in food in accordance with the following prescribed conditions: (a) The additive has a purity of not less than 99.97 percent. (b) It is used or intended for use, in accordance with good manufacturing practice, as a direct-contact freezing agent for foods. (c) To assure safe use of the additive: (1) The label of its container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, dichlorodifluoromethane, with or without the parenthetical name “Food Freezant 12”. (ii) The designation “food grade”. (2) The label or labeling of the food additive container shall bear adequate directions for use.

Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions: Food Chemicals Codex,http://www.usp.orghttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(a) The additive meets the specifications of the 7th ed. (2010), pp. 496 and 497, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address ). Copies 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: (b) The additive is used as an antimicrobial agent in the production of modified whey (including, but not limited to, whey protein concentrates and whey protein isolates) by ultrafiltration methods,…

Fixing agents may be safely used in the immobilization of enzyme preparations in accordance with the following conditions: (a) The materials consist of one or more of the following: (1) Substances generally recognized as safe in food. (2) Substances identified in this subparagraph and subject to such limitations as are provided: (b) The fixed enzyme preparation is washed to remove residues of the fixing materials. Table | Substances | Limitations | | --- | --- | | Acrylamide-acrylic acid resin: Complying with § 173.5(a)(1) and (b) of this chapter | May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. | | Cellulose triacetate | May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk. | | Diethylaminoethyl-cellulose | May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. | | Dimethylamine-epichlorohydrin resin: Complying with §…

The food additive octafluorocyclo-butane may be safely used as a propellant and aerating agent in foamed or sprayed food products in accordance with the following conditions: (a) The food additive meets the following specifications: (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, and propane, as a propellant and aerating agent for foamed or sprayed food products, except for those standardized foods that do not provide for such use. (c) To assure safe use of the additive: (1) The label of the food additive container shall bear, in addition to the other information required by the act, the following: (i) The name of the additive, octafluorocyclobutane. (ii) The percentage of the additive present in the case of a mixture. (iii) The designation “food grade”. (2) The label or labeling of the food additive container shall bear adequate directions for use.

Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions: (a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. http://www.usp.orghttp://www.archives.gov/federal-register/cfr/ibr-locations.html.(c) The additive meets the specifications for ozone in the Food Chemicals Codex, 7th ed. (2010), pp. 754-755, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers…

Peroxyacids may be safely used in accordance with the following prescribed conditions: (a) The additive is a mixture of peroxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-hydroxyethylidene-1,1-diphosphonic acid. (b)(1) The additive is used as an antimicrobial agent on meat carcasses, parts, trim, and organs in accordance with current industry practice where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 ppm. (2) The additive is used as an antimicrobial agent on poultry carcasses, poultry parts, and organs in accordance with current industry standards of good manufacturing practice (unless precluded by the U.S. Department of Agriculture's standards of identity in 9 CFR part 381, subpart P) where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, the maximum concentration of hydrogen peroxide is 110 ppm, and the maximum concentration of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) The…

Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions: http://www.archives.gov/federal-register/cfr/ibr-locations.html.(a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, May 1, 2007, pp. 1700-1701, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may examine a copy 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: (b) The additive is used in food as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter to treat the surface of raw poultry carcasses. The solution in which the…

Sodium methyl sulfate may be present in pectin in accordance with the following conditions. (a) It is present as the result of methylation of pectin by sulfuric acid and methyl alcohol and subsequent treatment with sodium bicarbonate. (b) It does not exceed 0.1 percent by weight of the pectin.

352352Trifluoromethane sulfonic acid has the empirical formula CFSOH (CAS Reg. No. 1493-13-6). The catalyst (Trifluoromethane sulfonic acid) may safely be used in the production of cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see § 184.1259 of this chapter) in accordance with the following conditions: (a) The catalyst meets the following specifications: (b) It is used at levels not to exceed 0.2 percent of the reaction mixture to catalyze the directed esterification. (c) The esterification reaction is quenched with steam and water and the catalyst is removed with the aqueous phase. Final traces of catalyst are removed by washing batches of the product three times with an aqueous solution of 0.5 percent sodium bicarbonate. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(d) No residual catalyst may remain in the product at a detection limit of 0.2 part per million fluoride as determined by the method described in “Official Methods of Analysis of the Association of Official Analytical Chemists,” sections 25.049-25.055, 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC…

Molecular sieve resins may be safely used in the processing of food under the following prescribed conditions: (a) The molecular sieve resins consist of purified dextran having an average molecular weight of 40,000, cross-linked with epichlorohydrin in a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a stable three dimensional structure. The resins have a pore size of 2.0 to 3.0 milliliters per gram of dry resin (expressed in terms of water regain), and a particle size of 10 to 300 microns. (b) The molecular sieve resins are thoroughly washed with potable water prior to their first use in contact with food. (c) Molecular sieve resins are used as the gel filtration media in the final purification of partially delactosed whey. The gel bed shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent microbial build-up on the bed and adulteration of the product.

Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is produced by one of the following methods: (1) Ammonolysis of natural tallow fatty acids to form amines that are subsequently reacted with methyl chloride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chloride and dimethyldihexadecylammonium chloride. The additive may contain residues of isopropyl alcohol not in excess of 18 percent by weight when used as a processing solvent. (2) Ammonolysis of natural tallow fatty acids to form amines that are then reacted with 2-ethylhexanal, reduced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of…

Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely used in accordance with the following prescribed conditions: (a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse. (b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is prepared for or served directly to the consumer. (c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section. [77 FR 71697, Dec. 4, 2012]

Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS Reg. No. 70247-90-4) may be safely used in food in accordance with the following prescribed conditions: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(a) The additives have a weight-average molecular weight in the range of 540 to 850 and a number-average molecular weight in the range of 520 to 650, calculated as the acid. Molecular weights shall be determined by a method entitled “Determination of Molecular Weight Distribution of Poly(Maleic) Acid,” March 17, 1992, produced by Ciba-Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, 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 are available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and…

Acrylate-acrylamide resins may be safely used in food under the following prescribed conditions: (a) The additive consists of one of the following: (1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is produced by the polymerization of acrylamide with partial hydrolysis, or by copolymerization of acrylamide and acrylic acid, with the greater part of the polymer being composed of acrylamide units. (2) Sodium polyacrylate-acrylamide resin is produced by the polymerization and subsequent hydrolysis of acrylonitrile in a sodium silicate-sodium hydroxide aqueous solution, with the greater part of the polymer being composed of acrylate units. (b) The additive contains not more than 0.05 percent of residual monomer calculated as acrylamide. (c) The additive is used or intended for use as follows: (1) The additive identified in paragraph (a)(1) of this section is used as a flocculent in the clarification of beet sugar juice and liquor or cane sugar juice and liquor or corn starch hydrolyzate in an amount not to exceed 5 parts per million by weight of the juice or 10 parts per million by weight of the liquor or the corn starch hydrolyzate. (2) The additive identified in…

The food additive polyvinylpolypyrrolidone may be safely used in accordance with the following prescribed conditions: (a) The additive is a homopolymer of purified vinylpyrrolidone catalytically produced under conditions producing polymerization and cross-linking such that an insoluble polymer is produced. (b) The food additive is so processed that when the finished polymer is refluxed for 3 hours with water, 5 percent acetic acid, and 50 percent alcohol, no more than 50 parts per million of extractables is obtained with each solvent. (c) It is used or intended for use as a clarifying agent in beverages and vinegar, followed by removal with filtration.

The food additive polyvinylpyrroli-done may be safely used in accordance with the following prescribed conditions: (a) The additive is a polymer of purified vinylpyrrolidone catalytically produced, having an average molecular weight of 40,000 and a maximum unsaturation of 1 percent, calculated as the monomer, except that the polyvinylpyrrolidone used in beer is that having an average molecular weight of 360,000 and a maximum unsaturation of 1 percent, calculated as the monomer. (b) The additive is used or intended for use in foods as follows: Table | Food | Limitations | | --- | --- | | Beer | As a clarifying agent, at a residual level not to exceed 10 parts per million. | | Flavor concentrates in tablet form | As a tableting adjuvent in an amount not to exceed good manufacturing practice. | | Nonnutritive sweeteners in concentrated liquid form | As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. | | Nonnutritive sweeteners in tablet form | As a tableting adjuvant in an amount not to exceed good manufacturing practice. | | Vitamin and mineral concentrates in liquid form | As a stabilizer, bodying agent, and dispersant, in an…

Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is produced by copolymerization of dimethylamine and epichlorohydrin in which not more than 5 mole-percent of dimethylamine may be replaced by an equimolar amount of ethylenediamine, and in which the mole ratio of total amine to epichlorohydrin is approximately 1:1. (b) The additive meets the following specifications: (1) The nitrogen content of the copolymer is 9.4 to 10.8 weight percent on a dry basis. (2) A 50-percent-by-weight aqueous solution of the copolymer has a minimum viscosity of 175 centipoises at 25 °C as determined by LVT-series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by another equivalent method). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(3) The additive contains not more than 1,000 parts per million of 1,3-dichloro-2-propanol and not more than 10 parts per million epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content is determined by an analytical method entitled “The Determination of Epichlorohydrin and…

Divinylbenzene copolymer may be used for the removal of organic substances from aqueous foods under the following prescribed conditions: (a) The copolymer is prepared in appropriate physical form and is derived by the polymerization of a grade of divinylbenzene which comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-percent ethylvinylbenzene, and no more than 4 weight-percent nonpolymerizable impurities. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) In accordance with the manufacturer's directions, the copolymer described in paragraph (a) of this section is subjected to pre-use extraction with a water soluble alcohol until the level of divinylbenzene in the extract is less than 50 parts per billion as determined by a method titled, “The Determination of Divinylbenzene in Alcohol Extracts of Amberlite XAD-4,” which is incorporated by reference. Copies of this method are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and…

Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. No. 60177-39-1) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is an aqueous dispersion of styrene-divinylbenzene copolymers, first chloromethylated then aminated with trimethylamine, having an average particle size of not more than 2.0 microns. (b) The additive shall contain no more than 3.0 percent nonvolatile, soluble extractives when tested as follows: One hundred grams of the additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear supernatant is removed from the compacted solids and concentrated to approximately 10 grams on a steam bath. The 10-gram sample is again centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble material. The supernatant from the second centrifugation is then removed from any compacted solids and dried to constant residual weight using a steam bath. The percent nonvolatile solubles is obtained by dividing the weight of the dried residue by the weight of the solids in the original resin dispersion. (c) The additive is used as a decolorizing and clarification agent for treatment of refinery sugar…

Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in food in accordance with the following prescribed conditions: (a) The additive is produced by the polymerization of acrylic acid and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide solution. As determined by a method entitled “Determination of Weight Average and Number Average Molecular Weight of Sodium Polyacrylate,” which is incorporated by reference in accordance with 5 U.S.C. 552(a), the additive has— (1) A weight average molecular weight of 2,000 to 2,300; and http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) A weight average molecular weight to number average molecular weight ratio of not more than 1.3. Copies of the method are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: (b) The additive is used to control mineral…

Sorbitan monooleate may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by the esterification of sorbitol with commercial oleic acid. (b) It meets the following specifications: (1) Saponification number, 145-160. (2) Hydroxyl number, 193-210. (c) The additive is used or intended for use as follows: (1) As an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion. (2) The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor. [51 FR 11720, Apr. 7, 1986]