2/8/2019 CFR - Code of Federal Regulations Title 21

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CFR - Code of Federal Regulations Title 21
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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR178.1010]

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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart B--Substances Utilized To Control the Growth of Microorganisms
Sec. 178.1010 Sanitizing solutions.

Sanitizing solutions may be safely used on food-processing equipment and utensils, and
on other food-contact articles as specified in this section, within the following
prescribed conditions:
(a) Such sanitizing solutions are used, followed by adequate draining, before contact
with food.
(b) The solutions consist of one of the following, to which may be added components
generally recognized as safe and components which are permitted by prior sanction or
approval.
(1) An aqueous solution containing potassium, sodium, or calcium hypochlorite, with or
without the bromides of potassium, sodium, or calcium.
(2) An aqueous solution containing dichloroisocyanuric acid, trichloroisocyanuric acid,
or the sodium or potassium salts of these acids, with or without the bromides of
potassium, sodium, or calcium.
(3) An aqueous solution containing potassium iodide, sodium p -toluenesulfonchloroamide,
and sodium lauryl sulfate.
(4) An aqueous solution containing iodine, butoxy monoether of mixed (ethylene-
propylene) polyalkylene glycol having a cloudpoint of 90deg. -100 deg. C in 0.5 percent
aqueous solution and an average molecular weight of 3,300, and ethylene glycol monobutyl
ether. Additionally, the aqueous solution may contain diethylene glycol monoethyl ether
as an optional ingredient.
(5) An aqueous solution containing elemental iodine, hydriodic acid, a -(p -
nonylphenyl)-omega -hydroxypoly-(oxyethylene) (complying with the identity prescribed in
178.3400(c) and having a maximum average molecular weight of 748) and/or
polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular
weight of 1,900). Additionally, the aqueous solution may contain isopropyl alcohol as an
optional ingredient.
(6) An aqueous solution containing elemental iodine, sodium iodide, sodium
dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block polymers (having a
minimum average molecular weight of 1,900).
(7) An aqueous solution containing dodecylbenzenesulfonic acid and either isopropyl
alcohol or polyoxyethylene-polyoxypropylene block polymers (having a minimum average
molecular weight of 2,800). In addition to use on food-processing equipment and

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utensils, this solution may be used on glass bottles and other glass containers intended
for holding milk.
(8) An aqueous solution containing elemental iodine, butoxy monoether of mixed
(ethylene-propylene) polyalkylene glycol having a minimum average molecular weight of
2,400 and [alpha]-lauroyl-omega -hydroxypoly (oxyethylene) with an average 8-9 moles of
ethylene oxide and an average molecular weight of 400. In addition to use on food-
processing equipment and utensils, this solution may be used on beverage containers,
including milk containers or equipment. Rinse water treated with this solution can be
recirculated as a preliminary rinse. It is not to be used as final rinse.
(9) An aqueous solution containing n -alkyl (C12-C18) benzyldimethylam-monium chloride
compounds having average molecular weights of 351 to 380. The alkyl groups consist
principally of groups with 12 to 16 carbon atoms and contain not more than 1 percent
each of groups with 8 and 10 carbon atoms. Additionally, the aqueous solution may
contain either ethyl alcohol or isopropyl alcohol as an optional ingredient.
(10) An aqueous solution containing trichloromelamine and either sodium lauryl sulfate
or dodecyl- benzenesulfonic acid. In addition to use on food-processing equipment and
utensils and other food-contact articles, this solution may be used on beverage
containers except milk containers or equipment.
(11) An aqueous solution containing equal amounts of n- alkyl (C12-C18) benzyl dimethyl
ammonium chloride and n- alkyl (C12-C18) dimethyl ethylbenzyl ammonium chloride (having
an average molecular weight of 384). In addition to use on food-processing equipment and
utensils, this solution may be used on food-contact surfaces in public eating places.
(12) An aqueous solution containing the sodium salt of sulfonated oleic acid,
polyoxyethylene-polyoxypropylene block polymers (having an average molecular weight of
2,000 and 27 to 31 moles of polyoxypropylene). In addition to use on food-processing
equipment and utensils, this solution may be used on glass bottles and other glass
containers intended for holding milk. All equipment, utensils, glass bottles, and other
glass containers treated with this sanitizing solution shall have a drainage period of
15 minutes prior to use in contact with food.
(13) An aqueous solution containing elemental iodine and alkyl (C12-C15) monoether of
mixed (ethylene-propylene) polyalkylene glycol, having a cloud-point of 70deg. -77 deg.
C in 1 percent aqueous solution and an average molecular weight of 807.
(14) An aqueous solution containing iodine, butoxy monoether of mixed (ethylene-
propylene) polyalkylene glycol, having a cloud-point of 90deg. -100 deg. C in 0.5
percent aqueous solution and an average molecular weight of 3,300, and polyoxyethylene-
polyoxypropylene block polymers (having a minimum average molecular weight of 2,000).
(15) An aqueous solution containing lithium hypochlorite.
(16) An aqueous solution containing equal amounts of n- alkyl (C12-C18) benzyl dimethyl
ammonium chloride and n- alkyl (C12-C14) dimethyl ethylbenzyl ammonium chloride (having
average molecular weights of 377 to 384), with the optional adjuvant substances
tetrasodium ethylenediaminetetraacetate and/or alpha- (p- nonylphenol)-omega- hydroxy
poly (oxyethylene) having an average poly- (oxyethylene) content of 11 moles. Alpha-
hydro-omega-hydroxypoly-(oxyethylene) poly(oxypropoylene) (15 to 18 mole minimum) poly
(oxyethylene) block copolymer, having a minimum molecular weight of 1,900 (CAS Registry
No. 9003-11-6) may be used in lieu of alpha- (p -nonylphenol)-omega-hydroxy-
poly(oxyethylene) having an average poly(oxyethylene) content of 11 moles. In addition
to use on food-processing equipment and utensils, this solution may be used on food-
contact surfaces in public eating places.
(17) An aqueous solution containing di-n -alkyl(C8-C10)dimethyl ammonium chlorides
having average molecular weights of 332-361 and either ethyl alcohol or isopropyl
alcohol. In addition to use on food-processing equipment and utensils, this solution may
be used on food-contact surfaces in public eating places.
(18) An aqueous solution containing n- alkyl(C12-C18) benzyldimethylammo-nium chloride,
sodium metaborate, alpha- terpineol and alpha [p- (1,1,3,3-tetramethylbutyl)phenyl] -
omega- hydroxy-poly (oxyethylene) produced with one mole of the phenol and 4 to 14 moles
ethylene oxide.
(19) An aqueous solution containing sodium dichloroisocyanurate and tetrasodium
ethylenediaminetetraacetate. In addition to use on food-processing equipment and
utensils, this solution may be used on food-contact surfaces in public eating places.
(20) An aqueous solution containing ortho- phenylphenol, ortho- benzyl-para-
chlorophenol, para-tertiaryamylphenol, sodium -alpha- alkyl(C12-C15)-omega- hydroxypoly
(oxyethylene) sulfate with the poly(oxyethylene) content averaging one mole, potassium
salts of coconut oil fatty acids, and isopropyl alcohol or hexylene glycol.
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(21) An aqueous solution containing sodium dodecylbenzenesulfonate. In addition to use

on food-processing equipment and utensils, this solution may be used on glass bottles
and other glass containers intended for holding milk.
(22) An aqueous solution containing (1) di-n- alkyl(C8-C10) dimethylammonium chloride
compounds having average molecular weights of 332-361, (2) n -alkyl (C12-C18)
benzyldimethylammonium chloride compounds having average molecular weights of 351-380
and consisting principally of alkyl groups with 12 to 16 carbon atoms with or without
not over 1 percent each of groups with 8 and 10 carbon atoms, and (3) ethyl alcohol. The
ratio of compound (1) to compound (2) is 60 to 40.
(23) An aqueous solution containing n -alkyl (C12-C16) benzyl-dimethylammonium chloride
and didecyldimethylammonium chloride.
(24) An aqueous solution containing elemental iodine (CAS Reg. No. 7553-56-2), alpha -[p
-(1,1,3,3-tetramethylbutyl)-phenyl]-omega- hydroxypoly-(oxyethylene) produced with one
mole of the phenol and 4 to 14 moles ethylene oxide, and alpha -alkyl(C12-C15)-omega -
hydroxy[poly(oxyethylene) poly(oxypropylene)] (having an average molecular weight of
965).
(25) An aqueous solution containing elemental iodine (CAS Reg. No. 7553-56-2), potassium
iodide (CAS Reg. No. 7681-11-0), and isopropanol (CAS Reg. No. 67-63-0). In addition to
use on food processing equipment and utensils, this solution may be used on beverage
containers, including milk containers and equipment and on food-contact surfaces in
public eating places.
(26) [Reserved]
(27) An aqueous solution containing decanoic acid (CAS Reg. No. 334-48-5), octanoic acid
(CAS Reg. No. 124-07-2), and sodium 1-octanesulfonate (CAS Reg. No. 5324-84-5).
Additionally, the aqueous solution may contain isopropyl alcohol (CAS Reg. No. 67-63-0)
as an optional ingredient.
(28) An aqueous solution containing sulfonated 9-octadecenoic acid (CAS Reg. No. 68988-
76-1) and sodium xylenesulfonate (CAS Reg. No. 1300-72-7).
(29) An aqueous solution containing dodecyldiphenyloxidedisulfonic acid (CAS Reg. No.
30260-73-2), sulfonated tall oil fatty acid (CAS Reg. No. 68309-27-3), and neo-decanoic
acid (CAS Reg. No. 26896-20-8). In addition to use on food-processing equipment and
utensils, this solution may be used on glass bottles and other glass containers intended
for holding milk.
(30) An aqueous solution containing hydrogen peroxide (CAS Reg. No. 7722-84-1),
peracetic acid (CAS Reg. No. 79-21-0), acetic acid (CAS Reg. No. 64-19-7), and 1-
hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4).
(31) An aqueous solution containing elemental iodine, alpha -alkyl(C10-C14)-omega -
hydroxypoly(oxyethylene)poly-(oxypropylene) of average molecular weight between 768 and
837, and alpha -alkyl(C12-C18)-omega -hydroxypoly(oxyethylene) poly(oxypropylene) of
average molecular weight between 950 and 1,120. In addition to use on food-processing
equipment and utensils, this solution may be used on food-contact surfaces in public
eating places.
(32) An aqueous solution containing (i) di-n -alkyl(C8-C10)dimethyl- ammonium chloride
compounds having average molecular weights of 332 to 361, (ii) n -alkyl(C12-
C18)benzyldimethyl- ammonium chloride compounds having average molecular weights of 351
to 380 and consisting principally of alkyl groups with 12 to 16 carbon atoms with no
more than 1 percent of groups with 8 and 10, (iii) ethyl alcohol, and (iv) alpha -(p -
nonylphenyl)-omega -hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p
-nonylphenol with 9 to 12 moles of ethylene oxide. The ratio of compound (i) to compound
(ii) is 3 to 2.
(33) An aqueous solution containing (i) di-n -alkyl-(C8-C10)-dimethylammonium chloride
compounds having average molecular weights of 332 to 361; (ii) n -alkyl(C12-C18) -
benzyldimethylammonium chloride compounds having molecular weights of 351 to 380 and
consisting principally of alkyl groups with 12 to 16 carbon atoms with no more than 1
percent of the groups with 8 to 10; and (iii) tetrasodium ethylenediamine tetraacetate.
Additionally, the aqueous solution contains either alpha -(p -nonylphenyl)-omega -
hydroxypoly-(oxyethylene) or alpha -alkyl(C11-C15)-omega -hydroxypoly-(oxyethylene),
each produced with 9 to 13 moles of ethylene oxide. The ratio of compound (i) to
compound (ii) is 3 to 2.
(34) An aqueous solution of an equilibrium mixture of oxychloro species (predominantly
chlorite, chlorate, and chlorine dioxide) generated either (i) by directly metering a
concentrated chlorine dioxide solution, prepared just prior to use, into potable water

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to provide the concentration of available chlorine dioxide stated in paragraph (c)(29)
of this section, or (ii) by acidification of an aqueous alkaline solution of oxychloro
species (predominantly chlorite and chlorate) followed by dilution with potable water to
provide the concentration of available chlorine dioxide described in paragraph (c)(29)
of this section.
(35) An aqueous solution containing decanoic acid (CAS Reg. No. 334-48-5), octanoic acid
(CAS Reg. No. 124-07-2), lactic acid (CAS Reg. No. 050-21-5), phosphoric acid (CAS Reg.
No. 7664-38-2) and a mixture of the sodium salt of naphthalenesulfonic acid (CAS Reg.
No. 1321-69-3); the methyl, dimethyl, and trimethyl dervatives of the sodium salt of
naphthalenesulfonic acid; and a mixture of the sodium salt of naphthalenesulfonic acid,
and the methyl, dimethyl, and trimethyl derivatives of the sodium salt of
naphthalenesulfonic acid alkylated at 3 percent by weight with C6-C9 linear olefins, as
components of a sanitizing solution to be used on food-processing equipment and
utensils. The methyl and dimethyl substituted derivatives (described within this
paragraph (b)(35)) constitute no less than 70 percent by weight of the mixture of
naphthalenesulfonates.
(36) The sanitizing solution contains decanoic acid (CAS Reg. No. 334-48-5); octanoic
acid (CAS Reg. No. 124-07-2); lactic acid (CAS Reg. No. 050-21-5); phosphoric acid (CAS
Reg. No. 7664-38-2); a mixture of 1-octanesulfonic acid (CAS Reg. No. 3944-72-7), and 1-
octanesulfonic-2-sulfinic acid (CAS Reg. No. 113652-56-5) or 1,2-octanedisulfonic acid
(CAS Reg. No. 113669-58-2); the condensate of four moles of
poly(oxyethylene)poly(oxypropylene) block copolymers with one mole of ethylenediamine
(CAS Reg. No. 11111-34-5); and the optional ingredient FD&C Yellow No. 5 (CAS Reg. No.
001934210). In addition to use on food-processing equipment and utensils, this solution
may be used on dairy-processing equipment.
(37) The sanitizing solution contains sodium hypochlorite (CAS Reg. No. 7681-52-9),
trisodium phosphate (CAS Reg. No. 7601-54-9), sodium lauryl sulfate (CAS Reg. No. 151-
21-3), and potassium permanganate (CAS Reg. No. 7722-64-7). Magnesium oxide (CAS Reg.
No. 1309-48-4) and potassium bromide (CAS Reg. No. 7758-02-3) may be added as optional
ingredients to this sanitizing solution. In addition to use on food-processing equipment
and utensils, this solution may be used on food-contact surfaces in public eating
places.
(38) An aqueous solution containing hydrogen peroxide (CAS Reg. No. 7722-84-1);
peroxyacetic acid (CAS Reg. No. 79-21-0); acetic acid (CAS Reg. No. 64-19-7); sulfuric
acid (CAS Reg. No. 7664-93-9); and 2,6-pyridinedicarboxylic acid (CAS Reg. No. 499-83-
2). In addition to use on food-processing equipment and utensils, this solution may be
used on dairy-processing equipment.
(39) An aqueous solution containing phosphoric acid (CAS Reg. No. 7664-38-2); octenyl
succinic acid (CAS Reg. No. 28805-58-5); N,N -dimethyloctanamine (CAS Reg. No. 7378-99-
6); and a mixture of n -carboxylic acids (C6-C12, consisting of not less than 56 percent
octanoic acid and not less than 40 percent decanoic acid). This solution may be used on
food-processing equipment and utensils, including dairy-processing equipment.
(40) An aqueous solution prepared by combining elemental iodine (CAS Reg. No. 7553-56-
2); hydriodic acid (CAS Reg. No. 10034-85-2); sodium N -cyclohexyl-N -palmitoyl taurate
(CAS Reg. No. 132-43-4); chloroacetic acid, sodium salt reaction products with 4,5-
dihydro-2-undecyl-1H -imidazole-1-ethanol and sodium hydroxide (CAS Reg. No. 68608-66-
2); dodecylbenzene sulfonic acid (CAS Reg. No. 27176-87-0); phosphoric acid (CAS Reg.
No. 7664-38-2); isopropyl alcohol (CAS Reg. No. 67-63-0); and calcium chloride (CAS Reg.
No. 10043-52-4). In addition to use on food-processing equipment and utensils, this
solution may be used on dairy-processing equipment.
(41) An aqueous solution containing n -alkyl(C12-C16)benzyldimethylammonium chloride,
having average molecular weights ranging from 351 to 380 wherein the alkyl groups
contain principally 12 to 16 carbons and not more than 1 percent each of the groups with
8 and 10 carbon atoms; ammonium chloride (CAS Reg. No. 12125-02-9); calcium stearate
(CAS Reg. No. 1592-23-0); sodium bicarbonate (CAS Reg. No. 144-55-8); starch or dextrin,
or both starch and dextrin (CAS Reg. No. 9004-53-9); and the optional ingredient
methylene blue (CAS Reg. No. 61-73-4). In addition to use on food-processing equipment
and utensils, this solution may be used on food-contact surfaces in public eating
places.
(42) An aqueous solution containing decanoic acid (CAS Reg. No. 334-48-5), nonanoic acid
(CAS Reg. No. 112-05-0), phosphoric acid (CAS Reg. No. 7664-38-2), propionic acid (CAS
Reg No. 79-09-04), and sodium 1-octanesulfonate (CAS Reg. No. 5324-84-5). Sulfuric acid
(CAS Reg. No. 7664-93-9) may be added as an optional ingredient. In addition to use on

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food-processing equipment and utensils, this solution may be used on dairy-processing
equipment.
(43) An aqueous solution of iodine and hypochlorous acid generated by the dilution of an
aqueous acidic (21.5 percent nitric acid) solution of iodine monochloride. In addition
to use on food-processing equipment and utensils, this solution may be used on dairy-
processing equipment.
(44) An aqueous solution of citric acid, disodium ethylenediaminetetraacetate, sodium
lauryl sulfate, and monosodium phosphate. In addition to use on food-processing
equipment and utensils, this solution may be used on dairy-processing equipment.
(45) An aqueous solution of hydrogen peroxide, acetic acid, peroxyacetic acid, octanoic
acid, peroxyoctanoic acid, sodium 1-octanesulfonate, and 1-hydroxyethylidene-1,1-
diphosphonic acid. In addition to use on food-processing equipment and utensils, this
solution may be used on food-contact surfaces in public eating places, subject to the
limitations in paragraph (c)(39) of this section.
(46) An aqueous solution of chlorine dioxide and related oxychloro species generated by
acidification of an aqueous solution of sodium chlorite with a solution of sodium
gluconate, citric acid, phosphoric acid, and sodium mono- and
didodecylphenoxybenzenedisulfonate. In addition to use on food-processing equipment and
utensils, this solution may be used on dairy-processing equipment.
(c) The solutions identified in paragraph (b) of this section will not exceed the
following concentrations:
(1) Solutions identified in paragraph (b)(1) of this section will provide not more than
200 parts per million of available halogen determined as available chlorine.
(2) Solutions identified in paragraph (b)(2) of this section will provide not more than
100 parts per million of available halogen determined as available chlorine.
(3) Solution identified in paragraph (b)(3) of this section will provide not more than
25 parts per million of titratable iodine. The solutions will contain the components
potassium iodide, sodium p- toluenesulfonchloramide and sodium lauryl sulfate at a level
not in excess of the minimum required to produce their intended functional effect.
(4) Solutions identified in paragraph (b)(4), (5), (6), (8), (13), and (14) of this
section will contain iodine to provide not more than 25 parts per million of titratable
iodine. The adjuvants used with the iodine will not be in excess of the minimum amounts
required to accomplish the intended technical effect.
(5) Solutions identified in paragraph (b)(7) of this section will provide not more than
400 parts per million dodecylbenzenesulfonic acid and not more than 80 parts per million
of polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular
weight of 2,800) or not more than 40 parts per million of isopropyl alcohol.
(6) Solutions identified in paragraph (b)(9) of this section shall provide when ready to
use no more than 200 parts per million of the active quaternary compound.
(7) Solutions identified in paragraph (b)(10) of this section shall provide not more
than sufficient trichloromelamine to produce 200 parts per million of available chlorine
and either sodium lauryl sulfate at a level not in excess of the minimum required to
produce its intended functional effect or not more than 400 parts per million of
dodecylbenzenesulfonic acid.
(8) Solutions identified in paragraph (b)(11) of this section shall provide, when ready
to use, not more than 200 parts per million of active quaternary compound.
(9) The solution identified in paragraph (b)(12) of this section shall provide not more
than 200 parts per million of sulfonated oleic acid, sodium salt.
(10) Solutions identified in paragraph (b)(15) of this section will provide not more
than 200 parts per million of available chlorine and not more than 30 ppm lithium.
(11) Solutions identified in paragraph (b)(16) of this section shall provide not more
than 200 parts per million of active quaternary compound.
(12) Solutions identified in paragraph (b)(17) of this section shall provide, when ready
to use, a level of 150 parts per million of the active quaternary compound.
(13) Solutions identified in paragraph (b)(18) of this section shall provide not more
than 200 parts per million of active quaternary compound and not more than 66 parts per
million of alpha [p- (1,1,3,3-tetramethylbutyl) phenyl]-omega- hydroxypoly
(oxyethylene).
(14) Solutions identified in paragraph (b)(19) of this section shall provide, when ready
to use, a level of 100 parts per million of available chlorine.

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(15) Solutions identified in paragraph (b)(20) of this section are for single use
applications only and shall provide, when ready to use, a level of 800 parts per million
of total active phenols consisting of 400 parts per million ortho- phenylphenol, 320
parts per million ortho- benzyl-para- chlorophenol and 80 parts per million para-
tertiaryamylphenol.
(16) Solution identified in paragraph (b)(21) of this section shall provide not more
than 430 parts per million and not less than 25 parts per million of sodium
dodecylbenzenesulfonate.
(17) Solutions identified in paragraph (b)(22) of this section shall provide, when ready
to use, at least 150 parts per million and not more than 400 parts per million of active
quaternary compound.
(18) Solutions identified in paragraph (b)(23) of this section shall provide at least
150 parts per million and not more than 200 parts per million of the active quaternary
compound.
(19) Solutions identified in paragraphs (b)(24), (b)(25), and (b)(43) of this section
shall provide at least 12.5 parts per million and not more than 25 parts per million of
titratable iodine. The adjuvants used with the iodine shall not be in excess of the
minimum amounts required to accomplish the intended technical effect.
(20)-(21) [Reserved]
(22) Solutions identified in paragraph (b)(27) of this section shall provide, when ready
to use, at least 109 parts per million and not more than 218 parts per million of total
active fatty acids and at least 156 parts per million and not more than 312 parts per
million of the sodium 1-octanesulfonate.
(23) Solutions identified in paragraph (b)(28) of this section shall provide, when ready
to use, at least 156 parts per million and not more than 312 parts per million of
sulfonated 9-octadecenoic acid, at least 31 parts per million and not more then 62 parts
per million of sodium xylenesulfonate.
(24) Solutions identified in paragraph (b)(29) of this section will provide at least 237
parts per million and not more than 474 parts per million dodecyldiphenyloxidedisulfonic
acid, at least 33 parts per million and not more than 66 parts per million sulfonated
tall oil fatty acid, and at least 87 parts per million and not more than 174 parts per
million neo-decanoic acid.
(25) Solutions identified in paragraph (b)(30) of this section shall provide, when ready
to use, not less than 550 parts per million and not more than 1,100 parts per million
hydrogen peroxide, not less than 100 parts per million and not more than 200 parts per
million peracetic acid, not less than 150 parts per million and not more than 300 parts
per million acetic acid, and not less than 15 parts per million and not more than 30
parts per million 1-hydroxyethylidene-1,1-diphosphonic acid.
(26) The solution identified in paragraph (b)(31) of this section shall provide, when
ready to use, at least 12.5 parts per million and not more than 25 parts per million of
titratable iodine. The adjuvants used with the iodine will not be in excess of the
minimum amounts required to accomplish the intended technical effect.
(27) Solutions identified in paragraph (b)(32) of this section shall provide, when ready
to use, at least 150 parts per million and no more than 400 parts per million of active
quarternary compounds in solutions containing no more than 600 parts per million water
hardness. The adjuvants used with the quarternary compounds will not exceed the amounts
required to accomplish the intended technical effect.
(28) Solutions identified in paragraph (b)(33) of this section shall provide, when ready
to use, at least 150 parts per million and not more than 400 parts per million of active
quaternary compounds. The adjuvants used with the quaternary compounds shall not exceed
the amounts required to accomplish the intended technical effect. Tetrasodium
ethylenediamine tetraacetate shall be added at a minimum level of 60 parts per million.
Use of these sanitizing solutions shall be limited to conditions of water hardness not
in excess of 300 parts per million.
(29) Solutions identified in paragraph (b)(34) of this section should provide, when
ready to use, at least 100 parts per million and not more than 200 parts per million
available chlorine dioxide as determined by the method titled "Iodometric Method for the
Determination of Available Chlorine Dioxide (50-250 ppm available ClO2)," which is
incorporated by reference. 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,

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call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(30) Solutions identified in paragraph (b)(35) of this section shall provide, when ready
for use, at least 117 parts per million and not more than 234 parts per million of total
fatty acids and at least 166 parts per million and not more than 332 parts per million
of a mixture of naphthalenesulfonates. The adjuvants phosphoric acid and lactic acid,
used with decanoic acid, octanoic acid, and sodium naphthalenesulfonate and its
alkylated derivatives, will not be in excess of the minimum amounts required to
accomplish the intended technical effects.
(31) Solutions identified in paragraph (b)(36) of this section shall provide, when ready
for use, at least 29 parts per million and not more than 58 parts per million decanoic
acid; at least 88 parts per million and not more than 176 parts per million of octanoic
acid; at least 69 parts per million and not more than 138 parts per million of lactic
acid; at least 256 parts per million and not more than 512 parts per million of
phosphoric acid; at least 86 parts per million and not more than 172 parts per million
of 1-octanesulfonic acid; at least 51 parts per million and not more than 102 parts per
million of 1-octanesulfonic-2-sulfinic acid or 1,2-octanedisulfonic acid; and at least
10 parts per million and not more than 20 parts per million of the condensate of four
moles of poly(oxyethylene)poly(oxypropylene) block copolymers with one mole of
ethylenediamine. The colorant adjuvant FD&C Yellow No. 5 shall not be used in excess of
the minimum amount required to accomplish the intended technical effect.
(32)(i) The solution identified in paragraph (b)(37) of this section without potassium
bromide shall provide, when ready to use, at least 100 parts per million and not more
than 200 parts per million of available halogen determined as available chlorine; at
least 2,958 parts per million and not more than 5,916 parts per million of trisodium
phosphate; at least 1 part per million and not more than 3 parts per million of sodium
lauryl sulfate; and at least 0.3 part per million and not more than 0.7 part per million
on potassium permanganate.
(ii) The solution identified in paragraph (b)(37) of this section with potassium bromide
shall provide, when ready to use, at least 25 parts per million and not more than 200
parts per million of available halogen determined as available chlorine; at least 15
parts per million and not more than 46 parts per million of potassium bromide; at least
690 parts per million and not more than 2,072 parts per million of trisodium phosphate;
at least 0.3 part per million and not more than 1 part per million of sodium lauryl
sulfate; and at least 0.1 part per million and not more than 0.3 part per million of
potassium permanganate.
(iii) Magnesium oxide when used in paragraph (c)(32) (i) or (ii) of this section shall
not be used in excess of the minimum amount required to accomplish its intended
technical effect.
(33) Solutions identified in paragraph (b)(38) of this section shall provide when ready
for use not less than 300 parts per million and not more than 465 parts per million of
hydrogen peroxide; not less than 200 parts per million and not more than 315 parts per
million of peroxyacetic acid; not less than 200 parts per million and not more than 340
parts per million of acetic acid; not less than 10 parts per million and not more than
20 parts per million of sulfuric acid; and not less than 0.75 parts per million and not
more than 1.2 parts per million of 2,6-pyridinedicarboxylic acid.
(34) Solutions identified in paragraph (b)(39) of this section shall provide when ready
for use not less than 460 parts per million and not more than 625 parts per million of
phosphoric acid, and all components shall be present in the following proportions: 1
part phosphoric acid to 0.25 octenyl succinic acid to 0.18 part N,N -dimethyloctanamine
to 0.062 part of a mixture of n -carboxylic acids (C6-C12, consisting of not less than
56 percent octanoic acid and not less than 40 percent decanoic acid).
(35) Solutions identified in paragraph (b)(40) of this section shall provide when ready
for use not less than 12.5 parts per million and not more than 25.0 parts per million of
titratable iodine; and not less than 2.7 parts per million and not more than 5.5 parts
per million of dodecylbenzene sulfonic acid. All components shall be present in the
following proportions: 1.0 part dodecylbenzene sulfonic acid to 43 parts sodium N -
cyclohexyl-N -palmitoyl taurate to 7.7 parts chloroacetic acid, sodium salt, reaction
products with 4,5-dihydro-2-undecyl-1H -imidazole-1-ethanol and sodium hydroxide to 114
parts phosphoric acid to 57 parts isopropyl alcohol to 3.0 parts calcium chloride.
(36) Solutions identified in paragraph (b)(41) of this section shall provide, when ready
for use, not less than 150 parts per million and not more than 200 parts per million of
n -alkyl(C12-C16)benzyldimethylammonium chloride; and not more than 0.4 part per million
of the colorant methylene blue. Components shall be present in the product used to

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prepare the solution in the following proportions: 1 part n -alkyl(C12-
C16)benzyldimethylammonium chloride to 0.24 part ammonium chloride to 0.08 part calcium
stearate to 0.60 part sodium bicarbonate to 0.08 part starch or dextrin, or a
combination of starch and dextrin.
(37)(i) The solution identified in paragraph (b)(42) of this section not containing
sulfuric acid shall provide when ready for use not less than 45 parts per million and
not more than 90 parts per million of decanoic acid; and all components shall be present
in the following proportions (weight/weight (w/w)): 1 part decanoic acid to 1 part
nonanoic acid to 9.5 parts phosphoric acid to 3.3 parts propionic acid to 3.3 parts
sodium 1-octanesulfonate.
(ii) The solution identified in paragraph (b)(42) of this section containing sulfuric
acid shall provide when ready for use not less than 45 parts per million and not more
than 90 parts per million of decanoic acid; and all components shall be present in the
following proportions (w/w): 1 part decanoic acid to 1 part nonanoic acid to 2.8 parts
phosphoric acid to 3.3 parts propionic acid to 3.3 parts sodium 1-octanesulfonate to 3.2
parts sulfuric acid.
(38) The solution identified in paragraph (b)(44) of this section shall provide, when
ready for use, at least 16,450 parts per million and not more than 32,900 parts per
million of citric acid; at least 700 parts per million and not more than 1,400 parts per
million of disodium ethylenediaminetetraacetate; at least 175 parts per million and not
more than 350 parts per million of sodium lauryl sulfate; and at least 175 parts per
million and not more than 350 parts per million of monosodium phosphate.
(39)(i) The solution identified in paragraph (b)(45) of this section, when used on food
processing equipment and utensils, including dairy and beverage-processing equipment but
excluding food-contact surfaces in public eating places and dairy and beverage
containers, shall provide when ready for use at least 72 parts per million and not more
than 216 parts per million of hydrogen peroxide; at least 46 parts per million and not
more than 138 parts per million of peroxyacetic acid; at least 40 parts per million and
not more than 122 parts per million of octanoic acid (including peroxyoctanoic acid); at
least 281 parts per million and not more than 686 parts per million of acetic acid; at
least 7 parts per million and not more than 34 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 36 parts per million and not more than 109 parts per
million of sodium 1-octanesulfonate.
(ii) The solution identified in paragraph (b)(45) of this section, when used on food-
contact equipment and utensils in warewashing machines, including warewashing machines
in public eating places, at temperatures no less than 120 deg. F (49 deg. C) shall
provide when ready for use at least 30 parts per million and not more than 91 parts per
million of hydrogen peroxide; at least 19 parts per million and not more than 58 parts
per million of peroxyacetic acid; at least 17 parts per million and not more than 52
parts per million of octanoic acid (including peroxyoctanoic acid); at least 119 parts
per million and not more than 290 parts per million of acetic acid; at least 3 parts per
million and not more than 14 parts per million of 1-hydroxyethylidene-1,1-diphosphonic
acid; and at least 15 parts per million and not more than 46 parts per million of sodium
1-octanesulfonate.
(iii) The solution identified in paragraph (b)(45) of this section, when used on dairy
or beverage containers, shall provide when ready for use at least 36 parts per million
and not more than 108 parts per million of hydrogen peroxide; at least 23 parts per
million and not more than 69 parts per million of peroxyacetic acid; at least 20 parts
per million and not more than 61 parts per million of octanoic acid (including
peroxyoctanoic acid); at least 140 parts per million and not more than 343 parts per
million of acetic acid; at least 3 parts per million and not more than 17 parts per
million of 1-hydroxyethylidene-1,1-diphosphonic acid; and at least 18 parts per million
and not more than 55 parts per million of sodium 1-octanesulfonate.
(40) The solution identified in paragraph (b)(46) of this section shall provide, when
ready for use, at least 100 parts per million and not more than 200 parts per million of
chlorine dioxide as determined by the method developed by Bio-cide International, Inc.,
entitled, "Iodometric Method for the Determination of Available Chlorine Dioxide (50-250
ppm Available ClO2)," dated June 11, 1987, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this method are available
from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1200, 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:
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http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
; at least 380 parts per million and not more than 760 parts per million of sodium
gluconate; and at least 960 parts per million and not more than 1,920 parts per million
of sodium mono- and didodecylphenoxybenzenedisulfonate. Other components listed under
paragraph (b)(46) of this section shall be used in the minimum amount necessary to
produce the intended effect.
(d) Sanitizing agents for use in accordance with this section will bear labeling meeting
the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act.
[42 FR 14609, Mar. 16, 1977]
Editorial Note:
For Federal Register citations affecting 178.1010, see the List of CFR Sections
Affected, which appears in the Finding Aids section of the printed volume and at
www.fdsys.gov.

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