21 C.F.R.

Subpart D—Specific Usage Additives

Title 21 - Food and Drugs

( http://law.justia.com/us/cfr/title21/21-3.0.1.1.4.4.html)

Title 21: Food and Drugs

PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN
CONSUMPTION

Browse Previous

Subpart D—Specific Usage Additives

§ 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–ClO 2 E in the “Standard Methods for the
Examination of Water and Wastewater,” 20th ed., 1998, or an equivalent method. Method 4500–ClO 2
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 Center for Food Safety and Applied Nutrition (HFS–
200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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 Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD, or at the National Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(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]

§ 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 resin... Contains not more than 0.05 percent by
weight of acrylamide monomer.Acrylic acid/2-acrylamido-2-methyl Total not to
exceed 20 parts per propane sulfonic acid copolymer million (active) in boiler having
a minimum weight average feedwater. 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'' (October 23, 1987), which is incorporated by reference in accordance with
5 U.S.C. 552(a). Copies may be obtained from the Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or may be examined at the National Archives and Records
Administration (NARA). For information on the availability of this material at NARA,
call 202- 741-6030, or go to: http:// www.archives.gov/federal_register/
code_of_federal_regulations/ ibr_locations.html..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- Minimum mol. wt. 1,500. polypropylene glycol produced by
random condensation of a 1:1 mixture by weight of ethylene oxide and propylene oxide
with butanol.Poly(acrylic acid-co- Total not to exceed 1.5 parts per
hypophosphite), sodium salt (CAS million in boiler feed water. Reg. No. 71050-62-
9), produced Copolymer contains not more than from a 4:1 to a 16:1 mixture by
0.5 percent by weight of acrylic weight of acrylic acid and sodium acid monomer (dry
weight basis). hypophosphite.Polyethylene glycol................ As defined in § 172.820 of
this chapter.Polymaleic acid [CAS Reg. No. 26099- Total not to exceed 1 part per 09-2],
and/or its sodium salt. million in boiler feed water [CAS Reg. No. 30915-61-8 or
CAS (calculated as the acid). Reg. No. 70247-90-4].Polyoxypropylene glycol............
Minimum mol. wt. 1,000.Potassium carbonate................Potassium
tripolyphosphate.........Sodium acetate.....................Sodium alginate....................Sodium
aluminate...................Sodium carbonate...................Sodium carboxymethylcellulose......
Contains 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
°C; by the method prescribed in the ``Food Chemicals Codex,''
4th ed. (1996), pp. 744-745, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the National
Academy Press, Box 285, 2101 Constitution Ave. NW.,
Washington, DC 20055 (Internet address http://
www.nap.edu), or may be examined at the Center for Food
Safety and Applied Nutrition's Library, Food
and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National
Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call
202- 741-6030, or go to: http://
www.archives.gov/federal_register/
code_of_federal_regulations/ ibr_locations.html.Sodium
glucoheptonate.............. Less 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 The mixture is used as an
mixture consisting of sorbitan anticorrosive agent in steam monostearate as defined
in § boiler distribution systems, with 172.842 of this chapter; each component
not to exceed 15 polysorbate 60 ((polyoxyethylene parts per million in the steam.
(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, 4th ed. (1996), pp. 306-307, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
National Academy Press, 2101 Constitution Ave. NW., Box 285, Washington, DC 20055
(Internet http://www.nap.edu), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA, call 202- 741-
6030, or go to: http:// www.archives.gov/federal_register/ code_of_federal_regulations/
ibr_locations.html..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------------------------------------------------------------------------
Cyclohexylamine......................... Not to exceed 10 parts per
million in steam, and excluding use of such steam
in contact with milk and milk
products.Diethylaminoethanol..................... Not to exceed 15 parts per
million in steam, and excluding use of such steam
in contact with milk and milk
products.Hydrazine............................... Zero in steam.Morpholine..............................
Not to exceed 10 parts per million in steam, and
excluding use of such steam in contact with milk and milk
products.Octadecylamine.......................... Not to exceed 3 parts per
million in steam, and excluding use of such steam
in contact with milk and milk products.Trisodium
nitrilotriacetate............. Not 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.

[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]

§ 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
May be used at a level not to alkyl alcohols and phosphate
esters of exceed 0.2 percent in lye- alkylene oxide adducts
of alkyl peeling solution to assist in alcohols
consisting of: α-alkyl the lye peeling of fruit and (C12-
C18)-omega-hydroxy-poly vegetables. (oxyethylene)
(7.5-8.5 moles)/poly (oxypropylene) block copolymer having an
average molecular weight of 810; α-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 α-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 anhydride.Aliphatic acid
mixture consisting of May be used at a level not to valeric, caproic, enanthic,
caprylic, exceed 1 percent in lye and pelargonic acids. peeling solution to
assist in the lye peeling of fruits and
vegetables.Polyacrylamide......................... Not 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 bromide...................... May be used in the washing or
to assist in the lye peeling of fruits and vegetables.Sodium n-
alkylbenzene-sulfonate (alkyl Not to exceed 0.2 percent in group predominantly C12
and C13 and wash water. May be used in not less than 95 percent C10 to C16).
washing or to assist in the lye peeling of fruits and
vegetables.Sodium dodecylbenzene-sulfonate (alkyl Do. group predominantly C12
and not less than 95% C10 to C16).Sodium 2 ethyl-hexyl sulfate........... Do.Sodium
hypochlorite.................... May be used in the washing or to
assist in the lye peeling of fruits and vegetables.Sodium mono-
and dimethyl naphthalene Not to exceed 0.2 percent in sulfonates (mol. wt. 245-260).
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--------------------------------------------------
----------------------α-Alkyl-omega-hydroxypoly-
Not to exceed 3 ppm. (oxyethylene) produced by condensation
of 1 mole of C11-C486315 straight chain randomly substituted
secondary alcohols with an average of 9 moles of ethylene
oxide.Linear undecylbenzenesulfonic acid........
Do.Dialkanolamide produced by condensing 1 Not to exceed
2 ppm. mole of methyl laurate with 1.05 moles of
diethanolamine.Triethanolamine...........................
Do.Ethylene glycol monobutyl ether........... Not to exceed
1 ppm.Oleic acid conforming with § 172.860 Do. of this
chapter.Tetrapotassium pyrophosphate.............. Not to
exceed 0.3 ppm.Monoethanolamine..........................
Do.Ethylene dichloride....................... Not to exceed
0.2 ppm.Tetrasodium ethylenediaminetetraacetate... Not 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
peroxide........................ Used in combination with
acetic acid to form
peroxyacetic acid. Not to
exceed 59 ppm in wash water.1-Hydroxyethylidene-1,1-
diphosphonic acid May be used only with
peroxyacetic acid. Not to
exceed 4.8 ppm in wash
water.Peroxyacetic acid........................ Prepared 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]

§ 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
cyanodithioimidocarbonate.............................
2.5Ethylenediamine................................................ 1.0Potassium N-
methyldithiocarbamate..............................
3.5------------------------------------------------------------------------
(2) Combination for cane-sugar mills:

-------------------------------------------------------------
-----------
Parts
per
million------------------------------------------------------
------------------Disodium
ethylenebisdithiocarbamate............................
3.0Sodium
dimethyldithiocarbamate.................................
3.0------------------------------------------------------------------------
(3) Combinations for cane-sugar mills and beet-sugar mills:

-------------------------------------------------------------
-----------
Parts
per
million------------------------------------------------------
------------------(i) Disodium
ethylenebisdithiocarbamate........................
3.0Ethylenediamine...........................................
..... 2.0Sodium
dimethyldithiocarbamate.................................
3.0(ii) Disodium
cyanodithioimidocarbonate........................
2.9Potassium N-methyldithiocarbamate..............................
4.1------------------------------------------------------------------------
(4) Single additive for cane-sugar mills and beet-sugar mills.
------------------------------------------------------------------------
Parts per million------------------------------------------------------------------------2,2-
Dibromo-3-nitrilopropionamide (CAS Not more than 10.0 and not Reg. No. 10222-
01-2). Limitations: less than 2.0. Byproduct molasses, bagasse, and pulp containing
residues of 2,2-dibromo-3- nitrilopropionamide are not authorized for use in animal
feed.------------------------------------------------------------------------
(5) Combination for cane-sugar mills:

-------------------------------------------------------------
-----------
Parts per
million------------------------------------------------------
------------------n-Dodecyl dimethyl benzyl ammonium
chloride............. 0.05±0.
005n-Dodecyl dimethyl ethylbenzyl ammonium chloride........
0.68±0.
068n-Hexadecyl dimethyl benzyl ammonium chloride...........
0.30±0.
030n-Octadecyl dimethyl benzyl ammonium chloride...........
0.05±0.
005n-Tetradecyl dimethyl benzyl ammonium chloride..........
0.60±0. 060n-Tetradecyl dimethyl
ethylbenzyl ammonium chloride..... 0.32±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- Not
more than 250. 8).------------------------------------------------------------------------
(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]

§ 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- May be used at an (oxyethylene) produced by
condensation of application rate not to a linear primary alcohol containing an
exceed 0.3 percent by average chain length of 10 carbons with weight of cottonseeds
to poly(oxyethylene) having an average of 5 enhance delinting of ethylene oxide units.
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 May be used at an coconut oil fatty acids and application
rate not to diethanolamine, CAS Reg. No. 068603-42-9. 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]

§ 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 Division of Petition Control (HFS–215), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740 20204–0001, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

[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]

§ 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 10
parts per million in food, or at free from hydrolyzable
chloride such level in a concentrated food and alkoxy
groups; no more than 18 that when prepared as directed on
percent loss in weight after the labels, the food in
its ready- heating 4 hours at 200 °C; for-consumption
state will have viscosity 300 to 1,050 centistokes not more
than 10 parts per million at 25 °C; refractive index
except as follows: Zero in milk; 1.400-1.404 at 25 °C).
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.Formaldehyde....................... As a preservative
in defoaming agents
containing
dimethylpolysiloxane, in an amount
not exceeding 1.0 percent of the
dimethylpolysiloxane content.α-Hydro-omega-hydroxy-poly
For use as prescribed in § (oxyethylene)/poly(oxypropylene)
172.808(b)(3) of this chapter. (minimum 15 moles)/
poly(oxyethylene) block copolymer (CAS Reg. No. 9003-11-6) as
defined in § 172.808(a)(3) of this chapter.Polyacrylic acid, sodium
salt...... As a stabilizer and thickener in defoaming agents
containing dimethylpolysiloxane in an amount
reasonably required to accomplish the intended
effect.Polyethylene glycol................ As defined in § 172.820 of
this chapter.Polyoxyethylene 40 monostearate.... As defined in U.S.P. XVI.Polysorbate
60..................... As defined in § 172.836 of this
chapter.Polysorbate 65..................... As defined in § 172.838 of
this chapter.Propylene glycol alginate.......... As defined in § 172.858 of
this chapter.Silicon dioxide.................... As defined in § 172.480 of
this chapter.Sorbitan monostearate.............. As defined in § 172.842 of
this chapter.White mineral oil: Conforming with As a component of defoaming agents
§ 172.878 of this chapter. 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
stearate...................... As defined in § 172.863 of this
chapter.Butyl stearate.........................BHA.................................... As an antioxidant, not
to exceed 0.1 percent by weight of
defoamer.BHT.................................... Do.Calcium stearate....................... As defined in
§ 172.863 of this chapter.Fatty acids............................ As
defined in § 172.860 of this
chapter.Formaldehyde........................... As a preservative.Hydroxylated
lecithin.................. As defined in § 172.814 of this
chapter.Isopropyl alcohol......................Magnesium stearate..................... As defined in
§ 172.863 of this chapter.Mineral oil: Conforming with §
Not more than 150 p.p.m. in 172.878 of this chapter. 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: As an
emulsifier not to exceed Conforming with § 172.820(a)(2) 10 percent by weight of of
this chapter and providing the defoamer formulation. oleic acid used in the
production of this substance complies with § 172.860 or § 172.862 of this
chapter.Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of
this chapter.Oleic acid derived from tall oil fatty Complying with § 172.862 acids.
of this chapter.Oxystearin............................. As defined in § 172.818 of
this chapter.Polyoxyethylene (600) dioleate.........Polyoxyethylene (600)
monoricinoleate..Polypropylene glycol................... Molecular weight range, 1,200-
3,000.Polysorbate 80......................... As defined in § 172.840 of
this chapter.Potassium stearate..................... As defined in § 172.863 of
this chapter.Propylene glycol mono- and diesters of As defined in § 172.856 of fats and
fatty acids. 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)- Viscosity range, 4,850-5,350
poly(oxypropylene)glycol. Saybolt Universal Seconds
(SUS) at 37.8 °C (100 °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 Division of Petition
Control, Center for Food Safety and Applied
Nutrition (HFS-215), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, and
may be examined at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For
information on the availability of this
material at NARA, call 202- 741-6030, or go to: http://
www.archives.gov/ federal_register/
code_of_federal_regulations/ ibr_locations.html.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]

§ 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]

§ 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]

§ 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
51/4 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 °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.

§ 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.

§ 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: May be used as a fixing material Complying with § 173.5(a)(1)
in the immobilization of glucose and (b) of this chapter. 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: May be used as a fixing material
Complying with § 173.60(a) and in the immobilization of glucose (b) of this chapter.
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 May be used as a fixing material with 1,2-
dichloroethane (CAS Reg.No. in the immobilization of 68130-97-2) is the reaction
product glucoamylase enzyme preparations of homopolymerization of from
Aspergillus niger for use ethylenimine in aqueous hydrochloric in the manufacture of
beer. acid at 100 °C and of cross- May be used as a fixing material linking with 1,2-
dichloroethane. The in the immobilization of: finished polymer has an average 1.
Glucose isomerase enzyme molecular weight of 50,000 to 70,000 preparations for use
in the as determined by gel permeation manufacture of high fructose
chromatography. The analytical corn syrup, in accordance with method is entitled
``Methodology for § 184.1372 of this chapter. Molecular Weight Detection of 2.
Glucoamylase enzyme Polyethylenimine,'' which is preparations from Aspergillus
incorporated by reference in niger for use in the manufacture accordance with 5
U.S.C. 552(a) and of beer. Residual ethylenimine 1 CFR part 51. Copies may be
in the finished polyethylenimine obtained from the Division of polymer will be
less than 1 part Petition Control, Center for Food per million as determined by gas
Safety and Applied Nutrition (HFS- chromatography-mass 200), 5100 Paint Branch
Pkwy., spectrometry. The residual College Park, MD 20740, and may be
ethylenimine is determined by an examined at the Center for Food analytical
method entitled Safety and Applied Nutrition's ``Methodology for Ethylenimine
Library, 5100 Paint Branch Pkwy., Detection in Polyethylenimine,'' College Park,
MD 20740, or at the which is incorporated by National Archives and Records
reference in accordance with 5 Administration (NARA). For U.S.C. 552(a) and 1
CFR part 51. information on the availability of Residual 1,2-dichloroethane in this
material at NARA, call 202-741- the finished polyethylenimine 6030, or go to: http://
polymer will be less than 1 part www.archives.gov/federal_register/ per million as
determined by gas code_of_federal_regulations/ chromatography. The residual
1,2- ibr_locations.html.. 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 Division
of Petition Control, Center for Food
Safety and Applied Nutrition (HFS-215), 5100 Paint
Branch Pkwy., College Park, MD 20740, or may be examined
at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National Archives and Records
Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/ federal_register/
code_of_federal_regulations/
ibr_locations.html.------------------------------------------------------------------------
(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]

§ 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.

§ 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, 4th ed. (1996), p. 277,
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 are available
from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be
examined at the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and at the National
Archives and Records Administration (NARA). For information on the availability of this material at NARA,
call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/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]

§ 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, 5100 Paint Branch Pkwy., College Park, MD 20740,
or you may examine a copy at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
[65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, 2002]

§ 173.375 Cetylpyridinium chloride.

Cetylpyridinium chloride (CAS Reg. No. 123–03–5) may be safely used in food in accordance with the
following prescribed conditions:

(a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary
(NF) methods described in USP 24/NF 19, p. 370, January 2000, 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
Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(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 additive is applied as a fine mist spray of an ambient
temperature aqueous solution 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. The aqueous solution 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 the cetylpyridinium chloride.

(c) The additive shall be used in systems that collect and recycle solution that is not carried out of the
system with the treated poultry carcasses.

[69 FR 17298, Apr. 2, 2004]

§ 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.

§ 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/federal_register/code_of_federal_regulations/ibr_locations.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]

§ 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, 5100
Paint Branch Pkwy., 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/federal_register/code_of_federal_regulations/ibr_locations.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, 5100
Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of this material at NARA, call 202–
741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(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]