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CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR173]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 173SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
 

Subpart D--Specific Usage Additives

Sec. 173.300 Chlorine dioxide.

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.

(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-ClO2 E in the "Standard Methods for the Examination of Water and Wastewater," 20th ed., 1998, or an equivalent method. Method 4500-ClO2 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, or the American Public Health Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(b)(1) The additive may be used as an antimicrobial agent in water used in poultry processing in an amount not to exceed 3 parts per million (ppm) residual chlorine dioxide as determined by Method 4500-ClO2 E, referenced in paragraph (a)(2) of this section, or an equivalent method.

(2) The additive may be used as an antimicrobial agent in water used to wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-ClO2 E, referenced in paragraph (a)(2) of this section, or an equivalent method. Treatment of the fruits and vegetables with chlorine dioxide shall be followed by a potable water rinse or by blanching, cooking, or canning.

[60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, 2005; 81 FR 5592, Feb. 3, 2016]

Sec. 173.310 Boiler water additives.

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:

Substances Limitations
Acrylamide-sodium acrylate resinContains not more than 0.05 percent by weight of acrylamide monomer.
Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copolymer having a minimum weight average molecular weight of 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled "Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS"Total not to exceed 20 parts per million (active) in boiler feedwater.
Ammonium alginate
Cobalt sulfate (as catalyst)
1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4) and its sodium and potassium salts
Lignosulfonic acid
Monobutyl ethers of polyethylene-polypropylene glycol produced by random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide with butanolMinimum mol. wt. 1,500.
Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. 71050-62-9), produced from a 4:1 to a 16:1 mixture by weight of acrylic acid and sodium hypophosphiteTotal not to exceed 1.5 parts per million in boiler feed water. Copolymer contains not more than 0.5 percent by weight of acrylic acid monomer (dry weight basis).
Polyethylene glycolAs defined in 172.820 of this chapter.
Polymaleic acid [CAS Reg. No. 26099-09-2], and/or its sodium salt. [CAS Reg. No. 30915-61-8 or CAS Reg. No. 70247-90-4]Total not to exceed 1 part per million in boiler feed water (calculated as the acid).
Polyoxypropylene glycolMinimum mol. wt. 1,000.
Potassium carbonate
Potassium tripolyphosphate
Sodium acetate
Sodium alginate
Sodium aluminate
Sodium carbonate
Sodium carboxymethylcelluloseContains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with maximum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 deg. C; by the "Viscosity of Cellulose Gum" method prescribed in the Food Chemicals Codex, pp. 1128-1129.
Sodium glucoheptonateLess than 1 part per million cyanide in the sodium glucoheptonate.
Sodium hexametaphosphate
Sodium humate
Sodium hydroxide
Sodium lignosulfonate
Sodium metabisulfite
Sodium metasilicate
Sodium nitrate
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate
Sodium polymethacrylate
Sodium silicate
Sodium sulfate
Sodium sulfite (neutral or alkaline)
Sodium tripolyphosphate
Sorbitol anhydride esters: A mixture consisting of sorbitan monostearate as defined in 172.842 of this chapter; polysorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as defined in 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, pp. 825-827.The mixture is used as an anticorrosive agent in steam boiler distribution systems, with each component not to exceed 15 milligrams per kilogram in the steam.
Tannin (including quebracho extract)
Tetrasodium EDTA
Tetrasodium pyrophosphate

(d) Substances used alone or in combination with substances in paragraph (c) of this section:

Substances Limitations
CyclohexylamineNot to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
DiethylaminoethanolNot to exceed 15 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
HydrazineZero in steam.
MorpholineNot to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
OctadecylamineNot to exceed 3 parts per million in steam, and excluding use of such steam in contact with milk and milk products.
Trisodium nitrilotriacetateNot to exceed 5 parts per million in boiler feedwater; not to be used where steam will be in contact with milk and milk products.

(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.

(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 the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.

(1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:

(i) "Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS" (October 23, 1987).

(ii) [Reserved]

(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ):

(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.

(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827.

[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, June 1, 1999; 78 FR 71466, Nov. 29, 2013]

Sec. 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables.

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:

Substances Limitations
A mixture of alkylene oxide adducts of alkyl alcohols and phosphate esters of alkylene oxide adducts of alkyl alcohols consisting of: [alpha]-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5-8.5 moles)/poly (oxypropylene) block copolymer having an average molecular weight of 810; [alpha]-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3-3.7 moles) polymer having an average molecular weight of 380, and subsequently esterified with 1.25 moles phosphoric anhydride; and [alpha]-alkyl (C10-C12)-omega-hydroxypoly (oxyethylene) (11.9-12.9 moles)/poly (oxypropylene) copolymer, having an average molecular weight of 810, and subsequently esterified with 1.25 moles phosphoric anhydrideMay be used at a level not to exceed 0.2 percent in lye-peeling solution to assist in the lye peeling of fruit and vegetables.
Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, and pelargonic acidsMay be used at a level not to exceed 1 percent in lye peeling solution to assist in the lye peeling of fruits and vegetables.
PolyacrylamideNot to exceed 10 parts per million in wash water. Contains not more than 0.2 percent acrylamide monomer. May be used in the washing of fruits and vegetables.
Potassium bromideMay be used in the washing or to assist in the lye peeling of fruits and vegetables.
Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 to C16)Not to exceed 0.2 percent in wash water. May be used in washing or to assist in the lye peeling of fruits and vegetables.
Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and not less than 95% C10 to C16) Do.
Sodium 2 ethyl-hexyl sulfate Do.
Sodium hypochloriteMay be used in the washing or to assist in the lye peeling of fruits and vegetables.
Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-260)Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables.

(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:

Substance Limitations
[alpha]-Alkyl-omega-hydroxypoly-(oxyethylene) produced by condensation of 1 mole of C11-C486315 straight chain randomly substituted secondary alcohols with an average of 9 moles of ethylene oxideNot to exceed 3 ppm.
Linear undecylbenzenesulfonic acid Do.
Dialkanolamide produced by condensing 1 mole of methyl laurate with 1.05 moles of diethanolamineNot to exceed 2 ppm.
Triethanolamine Do.
Ethylene glycol monobutyl etherNot to exceed 1 ppm.
Oleic acid conforming with 172.860 of this chapter Do.
Tetrapotassium pyrophosphateNot to exceed 0.3 ppm.
Monoethanolamine Do.
Ethylene dichlorideNot to exceed 0.2 ppm.
Tetrasodium ethylenediaminetetraacetateNot to exceed 0.1 ppm.

(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:

Substances Limitations
Hydrogen peroxideUsed in combination with acetic acid to form peroxyacetic acid. Not to exceed 59 ppm in wash water.
1-Hydroxyethylidene-1,1-diphosphonic acidMay be used only with peroxyacetic acid. Not to exceed 4.8 ppm in wash water.
Peroxyacetic acidPrepared by reacting acetic acid with hydrogen peroxide. Not to exceed 80 ppm in wash water.

(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), and (a)(4) is followed by rinsing with potable water to remove, to the extent possible, residues of the chemicals.

(d) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive or a statement of its composition.

(2) The label or labeling of the additive container shall bear adequate use directions to assure use in compliance with all provisions of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977; 42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 1999]

Sec. 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills.

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:

Parts per million
Disodium cyanodithioimidocarbonate2.5
Ethylenediamine1.0
Potassium N-methyldithiocarbamate3.5

(2) Combination for cane-sugar mills:

Parts per million
Disodium ethylenebisdithiocarbamate3.0
Sodium dimethyldithiocarbamate3.0

(3) Combinations for cane-sugar mills and beet-sugar mills:

Parts per million
(i) Disodium ethylenebisdithiocarbamate3.0
Ethylenediamine2.0
Sodium dimethyldithiocarbamate3.0
(ii) Disodium cyanodithioimidocarbonate2.9
Potassium N-methyldithiocarbamate4.1

(4) Single additive for cane-sugar mills and beet-sugar mills.

Parts per million
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222-01-2). Limitations: Byproduct molasses, bagasse, and pulp containing residues of 2,2-dibromo-3-nitrilopropionamide are not authorized for use in animal feedNot more than 10.0 and not less than 2.0.

(5) Combination for cane-sugar mills:

Parts per million
n-Dodecyl dimethyl benzyl ammonium chloride0.05+/-0.005
n-Dodecyl dimethyl ethylbenzyl ammonium chloride0.68+/-0.068
n-Hexadecyl dimethyl benzyl ammonium chloride0.30+/-0.030
n-Octadecyl dimethyl benzyl ammonium chloride0.05+/-0.005
n-Tetradecyl dimethyl benzyl ammonium chloride0.60+/-0.060
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride0.32+/-0.032

Limitations. Byproduct molasses, bagasse, and pulp containing residues of these quaternary ammonium salts are not authorized for use in animal feed.

(6) Single additive for beet-sugar mills:

Parts per million
Glutaraldehyde (CAS Reg. No. 111-30-8)Not more than 250.

(c) To assure safe use of the additives, their label and labeling shall conform to that registered with the Environmental Protection Agency.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992]

Sec. 173.322 Chemicals used in delinting cottonseed.

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:

Substances Limitations
alpha-Alkyl-omega-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 unitsMay 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. 068603-42-9May 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 animal feed.

[47 FR 8346, Feb. 26, 1982]

Sec. 173.325 Acidified sodium chlorite solutions.

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 to 2.9.

(3) When used in a prechiller or chiller solution, the additive is used at levels that result in sodium chlorite concentrations between 50 and 150 ppm, in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.8 to 3.2.

(c) The additive is used as an antimicrobial agent in accordance with current industry practice in the processing of red meat, red meat parts, and organs as a component of a spray or in the processing of red meat parts and organs as a component of a dip. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite concentrations between 500 and 1,200 ppm in combination with any GRAS acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.

(d)(1) The additive is used as an antimicrobial agent in water and ice that are used to rinse, wash, thaw, transport, or store seafood in accordance with current industry standards of good manufacturing practice. The additive is produced by mixing an aqueous solution of sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 to 2.9 and diluting this solution with water to achieve an actual use concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any seafood that is intended to be consumed raw shall be subjected to a potable water rinse prior to consumption.

(2) The additive is used as a single application in processing facilities as an antimicrobial agent to reduce pathogenic bacteria due to cross-contamination during the harvesting, handling, heading, evisceration, butchering, storing, holding, packing, or packaging of finfish and crustaceans; or following the filleting of finfish; in accordance with current industry standards of good manufacturing practice. Applied as a dip or spray, the additive is used at levels that result in a sodium chlorite concentration of 1,200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treated seafood shall be cooked prior to consumption.

(e) The additive is used as an antimicrobial agent on raw agricultural commodities in the preparing, packing, or holding of the food for commercial purposes, consistent with section 201(q)(1)(B)(i) of the act, and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with current industry standards of good manufacturing practice. Applied as a dip or a spray, the additive is used at levels that result in chlorite concentrations of 500 to 1200 parts per million (ppm), in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treatment of the raw agricultural commodities with acidified sodium chlorite solutions shall be followed by a potable water rinse, or by blanching, cooking, or canning.

(f) The additive is used as an antimicrobial agent on processed, comminuted or formed meat food products (unless precluded by standards of identity in 9 CFR part 319) prior to packaging of the food for commercial purposes, in accordance with current industry standards of good manufacturing practice. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite concentrations of 500 to 1200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.5 to 2.9.

(g) The additive is used as an antimicrobial agent in the water applied to processed fruits and processed root, tuber, bulb, legume, fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and tomato), and cucurbit vegetables in accordance with current industry standards of good manufacturing practices, as a component of a spray or dip solution, provided that such application be followed by a potable water rinse and a 24-hour holding period prior to consumption. However, for processed leafy vegetables (i.e., vegetables other than root, tuber, bulb, legume, fruiting, and cucurbit vegetables) and vegetables in the Brassica [Cole] family, application must be by dip treatment only, and must be preceded by a potable water rinse and followed by a potable water rinse and a 24-hour holding period prior to consumption. 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 ppm, in combination with any GRAS acid at a level sufficient to achieve a solution pH of 2.3 to 2.9.

(h) The concentration of sodium chlorite is determined by a method entitled "Determination of Sodium Chlorite: 50 ppm to 1500 ppm Concentration," September 13, 1995, developed by Alcide Corp., Redmond, WA, 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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.

[61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, 2004; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016]

Sec. 173.340 Defoaming agents.

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:

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 deg. C; viscosity 300 to 1,050 centistokes at 25 deg. C; refractive index 1.400-1.404 at 25 deg. C)10 parts per million in food, or at such level in a concentrated food that when prepared as directed on the labels, the food in its ready-for-consumption state will have not more than 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food.
FormaldehydeAs a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 percent of the dimethylpolysiloxane content.
[alpha]-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003-11-6) as defined in 172.808(a)(3) of this chapterFor use as prescribed in 172.808(b)(3) of this chapter.
Polyacrylic acid, sodium saltAs a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect.
Polyethylene glycolAs defined in 172.820 of this chapter.
Polyoxyethylene 40 monostearateAs defined in U.S.P. XVI.
Polysorbate 60As defined in 172.836 of this chapter.
Polysorbate 65As defined in 172.838 of this chapter.
Propylene glycol alginateAs defined in 172.858 of this chapter.
Silicon dioxideAs defined in 172.480 of this chapter.
Sorbitan monostearateAs defined in 172.842 of this chapter.
White mineral oil: Conforming with 172.878 of this chapterAs a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water.

(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:

Substances Limitations
Aluminum stearateAs defined in 172.863 of this chapter.
Butyl stearate
BHAAs an antioxidant, not to exceed 0.1 percent by weight of defoamer.
BHT Do.
Calcium stearateAs defined in 172.863 of this chapter.
Fatty acidsAs defined in 172.860 of this chapter.
FormaldehydeAs a preservative.
Hydroxylated lecithinAs defined in 172.814 of this chapter.
Isopropyl alcohol
Magnesium stearateAs defined in 172.863 of this chapter.
Mineral oil: Conforming with 172.878 of this chapterNot more than 150 p.p.m. in yeast, measured as hydrocarbons.
Odorless light petroleum hydrocarbons: Conforming with 172.884 of this chapter
Petrolatum: Conforming with 172.880 of this chapter
Petroleum wax: Conforming with 172.886 of this chapter
Petroleum wax, synthetic
Polyethylene glycol (400)dioleate: Conforming with 172.820(a)(2) of this chapter and providing the oleic acid used in the production of this substance complies with 172.860 or 172.862 of this chapterAs an emulsifier not to exceed 10 percent by weight of defoamer formulation.
Synthetic isoparaffinic petroleum hydrocarbons: Conforming with 172.882 of this chapter
Oleic acid derived from tall oil fatty acidsComplying with 172.862 of this chapter.
OxystearinAs defined in 172.818 of this chapter.
Polyoxyethylene (600) dioleate
Polyoxyethylene (600) monoricinoleate
Polypropylene glycolMolecular weight range, 1,200-3,000.
Polysorbate 80As defined in 172.840 of this chapter.
Potassium stearateAs defined in 172.863 of this chapter.
Propylene glycol mono- and diesters of fats and fatty acidsAs defined in 172.856 of this chapter.
Soybean oil fatty acids, hydroxylated
Tallow, hydrogenated, oxidized or sulfated
Tallow alcohol, hydrogenated

(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:

Substances Limitations
n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycolViscosity range, 4,850-5,350 Saybolt Universal Seconds (SUS) at 37.8 deg. C (100 deg. F). The viscosity range is determined by the method "Viscosity Determination of n-butoxypoly(oxyethylene)-poly(oxypropylene) glycol" dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference 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, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.
Monoester of alpha-hydro-omega-hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil

(b) They are added in an amount not in excess of that reasonably required to inhibit foaming.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998; 81 FR 5592, Feb. 3, 2016]

Sec. 173.342 Chlorofluorocarbon 113 and perfluorohexane.

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]

Sec. 173.345 Chloropentafluoroethane.

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 shall bear adequate directions for use.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, 1978]

Sec. 173.350 Combustion product gas.

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 products and other food, except fresh meats.

(d) To assure safe use of the additive in addition to the other information required by the act, the label or labeling of the combustion device shall bear adequate directions for use to provide a combustion product gas that complies with the limitations prescribed in paragraph (b) of this section, including instructions to assure proper filtration.

(e) The food additive is tested for compliance with paragraph (b)(2) by the following empirical method:

Spectrophotometric measurements. All measurements are made in an ultraviolet spectrophotometer in optical cells of 5 centimeters in length, and in the range of 255 millimicrons to 310 millimicrons, under the same instrumental conditions. The standard reference absorbance is the absorbance at 275 millimicrons of a standard reference solution of naphthalene (National Bureau of Standards Material No. 577 or equivalent in purity) containing a concentration of 1.4 milligrams per liter in purified isooctane, measured against isooctane of the same spectral purity in 5-centimeter cells. (This absorbance will be approximately 0.30.)

Solvent. The solvent used is pure grade isooctane having an ultraviolet absorbance not to exceed 0.05 measured against distilled water as a reference. Upon passage of purified inert gas through some isooctane under the identical conditions of the test, a lowering of the absorbance value has been observed. The absorbance of isooctane to be used in this procedure shall not be more than 0.02 lower in the range 255 millimicrons to 310 millimicrons, inclusive, than that of the untreated solvent as measured in a 5-centimeter cell. If necessary to obtain the prescribed purities, the isooctane may be passed through activated silica gel.

Apparatus. To assure reproducible results, the additive is passed into the isooctane solution through a gas-absorption train consisting of the following components and necessary connections:

1. A gas flow meter with a range up to 30 liters per hour provided with a constant differential relay or other device to maintain a constant flow rate independent of the input pressure.

2. An absorption apparatus consisting of an inlet gas dispersion tube inserted to the bottom of a covered cylindrical vessel with a suitable outlet on the vessel for effluent gas. The dimensions and arrangement of tube and vessel are such that the inlet tube introduces the gas at a point not above 5 1/4 inches below the surface of the solvent through a sintered glass outlet. The dimensions of the vessel are such, and both inlet and vessel are so designed, that the gas can be bubbled through 60 milliliters of isooctane solvent at a rate up to 30 liters per hour without mechanical loss of solvent. The level corresponding to 60 milliliters should be marked on the vessel.

3. A cooling bath containing crushed ice and water to permit immersion of the absorption vessel at least to the solvent level mark.

Caution. The various parts of the absorption train must be connected by gas-tight tubing and joints composed of materials which will neither remove components from nor add components to the gas stream. The gas source is connected in series to the flow-rate device, the flow meter, and the absorption apparatus in that order. Ventilation should be provided for the effluent gases which may contain carbon monoxide.

Sampling procedure. Immerse the gas-absorption apparatus containing 60 milliliters of isooctane in the coolant bath so that the solvent is completely immersed. Cool for at least 15 minutes and then pass 120 liters of the test gas through the absorption train at a rate of 30 liters per hour or less. Maintain the coolant bath at 0 deg. C throughout. Remove the absorption vessel from the bath, disconnect, and warm to room temperature. Add isooctane to bring the contents of the absorption vessel to 60 milliliters, and mix. Determine the absorbance of the solution in the 5-centimeter cell in the range 255 millimicrons to 310 millimicrons, inclusive, compared to isooctane. The absorbance of the solution of combustion product gas shall not exceed that of the isooctane solvent at any wavelength in the specified range by more than one-third of the standard reference absorbance.

Sec. 173.355 Dichlorodifluoromethane.

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.

Sec. 173.356 Hydrogen peroxide.

Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 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 http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(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, at a level not to exceed 0.001 percent by weight of the whey, providing that residual hydrogen peroxide is removed by appropriate chemical or physical means during the processing of the modified whey.

[76 FR 11330, Mar. 2, 2011, as amended at 81 FR 5592, Feb. 3, 2016]

Sec. 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.

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:

Substances Limitations
Acrylamide-acrylic acid resin: Complying with 173.5(a)(1) and (b) of this chapterMay 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 triacetateMay be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk.
Diethylaminoethyl-celluloseMay 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 173.60(a) and (b) of this chapterMay 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.
Glutaraldehyde Do.
Periodic acid (CAS Reg. No. 10450-60-9).
Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130-97-2) is the reaction product of homopolymerization of ethylenimine in aqueous hydrochloric acid at 100 deg. C and of cross-linking with 1,2-dichloroethane. The finished polymer has an average molecular weight of 50,000 to 70,000 as determined by gel permeation chromatography. The analytical method is entitled "Methodology for Molecular Weight Detection of Polyethylenimine," 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.htmlMay be used as a fixing material in the immobilization of glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer.
May be used as a fixing material in the immobilization of:
1. Glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with 184.1372 of this chapter.
2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. Residual ethylenimine in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography-mass spectrometry. The residual ethylenimine is determined by an analytical method entitled "Methodology for Ethylenimine Detection in Polyethylenimine," which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2-dichloroethane is determined by an analytical method entitled, "Methodology for Ethylenedichloride Detection in Polyethylenimine," 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(b) The fixed enzyme preparation is washed to remove residues of the fixing materials.

[48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002; 81 FR 5592, Feb. 3, 2016]

Sec. 173.360 Octafluorocyclobutane.

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:

99.99 percent octafluorocyclobutane.

Less than 0.1 part per million fluoroolefins, calculated as perfluoroisobutylene.

(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.

Sec. 173.368 Ozone.

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.

(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 http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.

(d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice.

(e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002, as amended at 78 FR 14665, Mar. 7, 2013; 78 FR 71467, Nov. 29, 2013]

Sec. 173.370 Peroxyacids.

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.

(c) The concentrations of peroxyacids and hydrogen peroxide in the additive are determined by a method entitled "Hydrogen Peroxide and Peracid (as Peracetic Acid) Content," July 26, 2000, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined by a method entitled "Determination of 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions," August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The Director of the Office of the Federal Register approves these incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods from the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federalregister/codeoffederalregulations/ibrlocations.html.

[65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, 2002; 81 FR 5593, Feb. 3, 2016]

Sec. 173.375 Cetylpyridinium chloride.

Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions:

(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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.

(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 additive is used to treat raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 57-55-6) complying with 184.1666 of this chapter, at a concentration of 1.5 times that of cetylpyridinium chloride.

(c) The additive is used as follows:

(1) As a fine mist spray of an ambient temperature aqueous solution applied to raw poultry carcasses prior to immersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solution that is not carried out of the system with the treated poultry carcasses; or

(2) As a liquid aqueous solution applied to raw poultry carcasses either prior to or after chilling at an amount not to exceed 5 gallons of solution per carcass, provided that the additive is used in systems that recapture at least 99 percent of the solution that is applied to the poultry carcasses. The concentration of cetylpyridinium chloride in the solution applied to the carcasses shall not exceed 0.8 percent by weight. When application of the additive is not followed by immersion in a chiller, the treatment will be followed by a potable water rinse of the carcass.

[72 FR 67576, Nov. 29, 2007, as amended at 76 FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3, 2016]

Sec. 173.385 Sodium methyl sulfate.

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.

Sec. 173.395 Trifluoromethane sulfonic acid.

Trifluoromethane sulfonic acid has the empirical formula CF3SO3H (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:

Appearance, Clear liquid.

Color, Colorless to amber.

Neutralization equivalent, 147-151.

Water, 1 percent maximum.

Fluoride ion, 0.03 percent maximum.

Heavy metals (as Pb), 30 parts per million maximum.

Arsenic (as As), 3 parts per million maximum.

(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.

(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 INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]

Sec. 173.400 Dimethyldialkylammonium chloride.

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.

(b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of free amine and amine hydrochloride. The food additive described in paragraph (a)(2) of this section contains not more than 3 percent by weight, each, of free amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, "Acid Value and Free Amine Value of Fatty Quaternary Ammonium Chlorides," 2d printing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, 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/federalregister/codeoffederalregulations/ibrlocations.html.

(c) The food additive is used as a decolorizing agent in the clarification of refinery sugar liquors under the following limitations:

(1) The food additive described in paragraph (a)(1) of this section is added only at the defecation/clarification stage of sugar liquor refining in an amount not to exceed 700 parts per million by weight of sugar solids.

(2) The food additive described in paragraph (a)(2) of this section is used under the following conditions:

(i) The additive is adsorbed onto a support column composed of suitable polymers that are regulated for contact with aqueous food. Excess nonadsorbed additive shall be rinsed away with potable water prior to passage of sugar liquor through the column.

(ii) The residue of the additive in the decolorized sugar liquor prior to crystallization shall not exceed 1 part per million of sugar as determined by a method entitled "Colorimetric Determination of Residual Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar Solutions," June 13, 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]

Sec. 173.405 Sodium dodecylbenzenesulfonate.

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]

Authority: 21 U.S.C. 321, 342, 348.
Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.

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