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178.1010 Sanitizing solutions.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.1010]

[Page 358-367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
  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 90[deg]-
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 Sec.  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

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food-processing equipment and 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 70[deg]-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 
90[deg]-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

[[Page 360]]

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.
    (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.

[[Page 361]]

    (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 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-

[[Page 362]]

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 
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

[[Page 363]]

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.
    (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]

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    (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, 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.
    (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

[[Page 365]]

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 prepare the solution in the following 
proportions: 1 part n-alkyl(C12-

[[Page 366]]

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

[[Page 367]]

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 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, 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; 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 Sec.  
178.1010, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 1010


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