Guidance Acidificado

8/9/2019 Guidance Acidificado

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Contains Nonbinding Recommendations

Draft Not for Implementation

Guidance for Industry $

Acidified Foods

his draft guidance, hen finali3ed, ill re$resent the Food and rug Administration4s (F A4s)current thin!ing on this to$ic. t does not create or confer any rights for or on any $erson anddoes not o$erate to bind F A or the $ublic. 6ou can use an alternati"e a$$roach if the a$$roachsatisfies the re/uirements of the a$$licable statutes and regulations. f you ant to discuss analternati"e a$$roach, contact the F A staff res$onsible for im$lementing this guidance. f youcannot identify the a$$ro$riate F A staff, call the tele$hone number listed on the title $age ofthis guidance.

I. Introductionhis guidance is intended for $rocessors of acidified foods, fermented foods

2, and acid foods

,. t

$ertains to the current good manufacturing $ractice (C7 8) re/uirements in 21 CFR $art 11for acidified foods and to the 9%$ecific Re/uirements and Conditions for :;em$tion From orCom$liance ect tothese regulations. t also $ro"ides F A?s (our) current thin!ing on se"eral to$ics related to the

$rocessing of, and $rocess filings for, acidified foods and describes a "oluntary $rogram for $rocessors of foods that may not be sub>ect to the regulations for acidified foods. @nder the"oluntary $rogram, $rocessors may submit $rocess filings for these foods to facilitate ourdeterminations regarding the regulatory status of their foods during ins$ection of a $rocessor?sfacility and hen their foods are offered for im$ort. a!ing $art in this "oluntary $rogram doesnot automatically sub>ect $rocessors to the acidified food regulations.

F A4s guidance documents, including this guidance, do not establish legally enforceableres$onsibilities. nstead, guidances describe the Agency4s current thin!ing on a to$ic and should

be "ie ed only as recommendations, unless s$ecific regulatory or statutory re/uirements are

1 his guidance has been $re$ared by the ffice of Food %afety in the Center for Food %afety and A$$lied

utrition at the @.%. Food and rug Administration.2 Fermented dairy $roducts, such as yogurt, are a se$arate category that is not rele"ant to the fermented foodsthat are the sub>ect of this document.

-o +acid foods are foods, other than alcoholic be"erages, ith a finished e/uilibrium $* greater than .# and aater acti"ity greater than 0. 5, e;ce$t that tomatoes and tomato $roducts ha"ing a finished e/uilibrium $* lessthan .B are not classed as lo +acid foods (21 CFR 11 . (n)). Acidified foods are lo +acid foods to hich acid(s) or acid food(s) are added they ha"e a ater acti"ity greater than 0. 5 and ha"e a finished e/uilibrium $* of .# or

belo (21 CFR 11 . (b)). Acid foods are foods that ha"e a natural $* of .# or belo (21 CFR 11 . (a)).Fermented foods, as discussed in this guidance, are lo +acid foods sub>ected to the action of acid+$roducingmicroorganisms to reduce the $* of the food to .# or belo .


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of a food is .# or belo , s$ores of C. botulinum ill not germinate and gro ( 1 FR 0 2 at0 2)

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he regulations in 21 CFR $art 11 for -ACF define a scheduled $rocess as the $rocess selected by the $rocessor as ade/uate under the conditions of manufacture for a gi"en $roduct to achie"e

commercial sterility (21 CFR 11 . (r)). 9Commercial sterility= of thermally $rocessed foodmeans the condition achie"ed either by 1) the a$$lication of heat hich renders the food free ofmicroorganisms ca$able of re$roducing in the food under normal nonrefrigerated conditions ofstorage and distribution and free of "iable microorganisms (including s$ores) of $ublic healthsignificance, or by 2) the control of ater acti"ity and the a$$lication of heat hich renders thefood free of microorganisms ca$able of re$roducing in the food under normal nonrefrigeratedconditions of storage and distribution (21 CFR 11 . (e)).

he regulations in 21 CFR $art 11 for acidified foods define a scheduled $rocess as the $rocessselected by a $rocessor as ade/uate for use under the conditions of manufacture for a food inachie"ing and maintaining a food that ill not $ermit the gro th of microorganisms ha"ing

$ublic health significance. t includes control of $* and other critical factors e/ui"alent to the $rocess established by a com$etent $rocessing authority (21 CFR 11 . (e)). ecause the $* ofacidified foods is sufficiently lo to $re"ent the germination of s$ores of C. botulinum , acidifiedfoods may be held at ambient tem$erature ithout a heat treatment com$arable to that a$$lied tolo +acid foods sub>ect to the re/uirements of 21 CFR $art 11 ( 1 FR 0 2 at 0 2).

%ince the C7 8 re/uirements in 21 CFR $art 11 ere established, acid+tolerant $athogenicmicroorganisms (such as !scherichia coli "#$%&'% ( !. coli "#$%&' % ) and almonella s$ecies)ha"e caused outbrea!s of foodborne illness in acid >uices such as a$$le >uice and orange >uice(Refs. 10 + 12). %cientists ha"e e;$ressed concern that such acid+tolerant $athogens couldsur"i"e in acidified foods and ha"e in"estigated $rocessing conditions to ade/uately reduce B the

number of "iable cells of $athogens such as !. coli "#$%&'% , almonella s$ecies, and Listeriamonoc togenes ( L. monoc togenes ) in acidified foods (Refs. 1 and 1 ).

6ou should refer to 21 CFR $art 11 for the com$lete C7 8 re/uirements for acidified foods.

%. mergency (ermit ontrol )e*uirements for Acidified Foods


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lo +acid foods hen those foods are intended for use in hermetically sealed containers ( FR 1#2 0 at 1#2 1). herefore, tomatoes and tomato $roducts ith a finished e/uilibrium $*greater than .#, but belo .B, do not meet the definitions of acid foods, acidified foods, or lo +acid foods. *o e"er, for the $ur$ose of this document, e recommend that you consider suchtomatoes to be acid foods.

he natural $* range of a food (such as oranges) may be !no n to be .# or belo , but hethera $ac!aged food is an acidified food or an acid food may not be readily a$$arent solely from thea$$earance of the food. hus, e often must determine, during ins$ection of a $rocessor?sfacility and hen foods are offered for im$ort, hether a $articular $ac!aged food is indeed an9acid food= that is not sub>ect to the regulations in 21 CFR 10 .25 and $art 11 , or is instead an9acidified food= that is sub>ect to these regulations. o do so, e e"aluate information $ro"idedto us by the $rocessor to determine hether the information is consistent ith a $rocessor?sconclusion that its $roduct is an acid food.

8rocessors ho are not certain as to hether s$ecific food $roducts are acidified foods sub>ect toregistration and $rocess filing re/uirements sometimes $ro"ide us ith information about theirfood $roducts by "oluntarily submitting Forms F A 25 1 and 25 1a. f e ha"e suchinformation in our files, e can more readily determine hether it is consistent ith a

$rocessor4s conclusion that a $roduct is an acid food and thus not sub>ect to the re/uirementsa$$licable to acidified foods.

f you choose to submit to F A $rocess filing information about a food that you conclude is anacid food using Form F A 25 1a, e recommend that you&

H Register your facility using Form F A 25 1 if you ha"e not done so $re"iously (e.g., because you do not also $rocess any acidified foods or lo +acid foods). oing so illenable you to com$lete the $rocess filing form (Form F A 25 1a), hich re/uests theFood Canning :stablishment (FC:) number e assign to your facility hen you register using Form F A 25 1 and

H %ubmit one $a$er+based $rocess filing form for each food that you conclude is an acidfood, and include dimensions for all container si3es on that single form, rather thansubmitting one electronic form for each container si3e of that food. his ill ma!e anyre"ie by us more efficient. At this time, our electronic filing system does not $rocessmulti$le container si3es for a single filing.

f you conclude that your $roduct is an acid food, rather than an acidified food, and "oluntarilysubmit $rocess information about that food using Forms F A 25 1 and 25 1a, e intend tocontinue to e"aluate the $rocess information to determine hether it is consistent ith yourconclusion that your $roduct is an acid food that is not sub>ect to the re/uirements of 21 CFR

$art 11 and 21 CFR 10 .25.


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f you "oluntarily submit $rocess information about a food using Forms F A 25 1 and 25 1a,and later change the scheduled $rocess for that food or change ingredients in a ay that couldaffect the $* of the finished $roduct, you should submit a Form F A 25 1a ith u$datedinformation. As e do no , during ins$ection of your facility, or hen your $roduct is offeredfor im$ort, e may as! to see information "erifying that your scheduled $rocess is consistent

ith your characteri3ation of your $roduct as an acid food.

%. Acidified Foods

9Acidified foods= are lo +acid foods to hich acid(s) or acid food(s) are added.

they ha"e aater acti"ity greater than 0. 5 and ha"e a finished e/uilibrium $* of .# or belo (21 CFR 11 . (b)). he definition of acidified foods $ro"ides that carbonated be"erages and foods thatare stored, distributed, and retailed under refrigeration are e;cluded from the co"erage of 21 CFR

$art 11 (21 CFR 11 . (b)).

n the final rule establishing 21 CFR $art 11 ( FR 1#2 0 at 1#2 2), e s$ecifically e;cluded >ams, >ellies and $reser"es from the general definition of acidified foods because e;$erience andre"ie of the e"idence sho that bacteria of $ublic health significance cannot and do not gro inthese foods. hus, under 21 CFR 11 . (b), >ams, >ellies, and $reser"es are e;cluded from theco"erage of 21 CFR $art 11 . ams, >ellies, and $reser"es that meet an a$$licablestandard of identity under 21 CFR $art 150 to be e;cluded from the co"erage of 21 CFR $art11 . ellies (including non+fruit >ellies), nonstandardi3ed

>ams, and nonstandardi3ed $reser"es are co"ered by 21 CFR $art 11 based on the $* of thefruit, the $* of the final $roduct, and the ater acti"ity le"el of the final $roduct.

A food containing both acid food(s) and lo +acid food(s) may or may not be co"ered by 21 CFR $art 11 as an acidified food. @nder 21 CFR 11 . (b), acid foods that contain small amounts oflo +acid food(s) and ha"e a resultant finished e/uilibrium $* that does not significantly differfrom that of the $redominant acid or acid food are e;cluded from the co"erage of $art 11 (21CFR 11 . (b)). he regulation in 21 CFR 11 . (b) establishes t o criteria that must be satisfiedto /ualify for this e;clusion& (1) the amount of lo +acid food(s) in the $roduct must be a 9smallamount,= and (2) the finished e/uilibrium $* must not differ significantly from that of the

$redominant acid or acid food. %ee %ection .* of this guidance for recommendations on hoto determine hether a food containing both acid food(s) and lo +acid food(s) is co"ered under 21 CFR $art 11 .


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H 8ic!led beets, coc!tail onions, and cherry $e$$ers (normally $ic!led by the addition of acid)

H Red bell $e$$ers treated in an acid brineH %ome $ears and tro$ical fruits that ha"e a natural $* greater than .# and are acidified to

a $* of .# or beloH Fermented green oli"es sub>ected to $rocesses (such as lye treatment or ashing ith

lo +acid foods) that raise the $* abo"e .#, ith subse/uent addition of acid or acidfoods to reduce the $* to .# or belo

H omato salsa made from tomatoes ith a $* of .# or belo and lo +acid ingredients,hen the amount of lo +acid ingredients is not a small amount and'or the resultantfinished e/uilibrium $* differs significantly from that of the $redominant acid or acidfood (see, e.g., :;am$le in A$$endi; 1) and

H Cold+$ac! $ic!les that are sub>ected to the action of acid+$roducing microorganisms butre/uire the addition of acid or an acid food to achie"e a $* of .# or belo .

. Fermented Foods

he $ro$osed rules to establish 21 CFR 10 .25 ( 1 FR 0 2) and $art 11 ( 1 FR 0 5B)s$ecifically addressed fermented foods and $ic!led foods (e.g., the title of the $ro$osedregulations included fermented foods and $ic!led foods). Fermented foods (such as some !indsof sauer!raut, cucumber $ic!les, and green oli"es) are lo +acid foods sub>ected to the action ofacid+$roducing microorganisms to reduce the $* of the food to .# or belo . 8ic!led foods arelo +acid foods that are reduced to a $* of .# or belo either by fermentation or by marinatingin an acid solution (usually "inegar, i.e., acetic acid). 8ic!led foods may be maintained andstored in either the acid solution resulting from fermentation or in the marinating solution, or in afresh acid solution a$$lied after fermentation or marinating is com$lete.

Comments to the $ro$osed rules noted that the $ro$osed rules ga"e no e;am$les in hich any $ro"en im$ro$er fermentation caused a fermented food to be a health ha3ard ( FR 1#20 at1#20 FR 1#2 0 at 1#2 1). hese comments /uestioned the inclusion of fermented foods inthe regulations. n the final rules e ac!no ledged that e could not find re$orts of cases of

botulism caused by commercially $rocessed fermented foods ( FR 1#20 at 1#20 FR 1#2 0 at 1#2 1).


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(i.e., 9acid food containing small amounts of lo +acid food(s),= 9acid ingredient,= 9lo +acidingredient,= 9shift in $*,= 9small amount $ro"ision,= and 9 ater+based li/uid=) e use for the

$ur$ose of this guidance.H 9Acid food containing small amounts of lo +acid food(s)= +


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H 9%hift in $*= + uiceor mil!). For the $ur$ose of this guidance, e are not considering fruit >uice for hich astandard of identity is established in 21 CFR $art 1 #, other fruit >uices such as a$$le

>uice, blended >uices, and reconstituted >uices and "egetable >uices to be 9 ater+basedli/uids.=

*. !+amples of foods that may be acid foods containing small amounts of lo,-acid food(s)

he follo ing are e;am$les of foods that may be acid foods containing small amounts of lo +acid food(s) de$ending on the $ercent by eight of lo +acid food(s) in the finished $roduct andthe significance of the shift in $* bet een the finished food and the $redominant acid or acidfood(s). he ste$s e recommend that you follo in calculating the $ercent by eight of lo +acid food(s), and in e"aluating the significance of the shift in $*, are described in ables through # in %ection .*.5 of this document. For e;am$les of calculations and analyses usingables through #, see A$$endi; 1.

Tomato puree with added spices:


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H 8redominant acid food& omato $uree.H -o +acid ingredients& %$ices.

Thousand Island Salad Dressin g &H 8redominant acid food& i;ture of all acid ingredients, such as mayonnaise, lemon >uice,

and tomato $aste.H -o +acid ingredients& 7reen $e$$ers, celery, and onions.

Ketchup with added color &H 8redominant acid food& i;ture of all acid ingredients, such as tomato concentrate and

"inegar.H -o +acid ingredients& Color additi"e to ma!e the !etchu$ green and other ingredients

such as s$ices and corn syru$.

. !+amples of foods that are not an acid food containing small amounts of lo,-acid food(s)

he follo ing are e;am$les of foods to hich the calculations in the ecision ables ( ables 2through #) in %ection .*.5 do not a$$ly because the foods are not acid foods containing smallamounts of lo +acid food(s). Foods such as those described belo are co"ered by 21 CFR $art11 .

Tomato salsa made from low acid tomatoes processed by acidification to p! "#$% fresh onions% garlic% peppers% salt and spice s &

H he food is not an acid food containing small amounts of lo +acid food(s) because thefinished food does not contain any acid foods. he tomatoes are an acidified food, andthe remaining ingredients are lo +acid foods. he small amount $ro"ision does not

a$$ly hen lo +acid foods are added to an acidified food.

Green oli&es 'pre&iously prepared by fermentation( that are reprocessed by stuf f i ng with a lowacid foo d &

H he stuffed green oli"es are not an acid food containing small amounts of lo +acidfood(s) because the green oli"es are a fermented food rather than an acid food.Fermented foods are lo +acid foods sub>ected to the action of acid+$roducingmicroorganisms to reduce the $* of the food to .# or belo and, therefore, are not acidfoods as defined by 21 CFR 11 . (a).

/. 0ater-based li1uids (other than carbonated be2erages) ,ith a p' of /.3 or belo,

uice, usually to reduce and stabili3e the $* to .# or belo . he /uantitati"e amountof ater in a ater+based li/uid is greater than the /uantitati"e amounts of all other ingredientscombined, regardless of hether the other ingredients are acid foods or lo +acid foods.herefore, based on the definitions of 9 ater+based li/uids= and 9small amount of lo +acidfood(s)= used in this guidance, the total amount of lo +acid food in a ater+based li/uid should


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not be considered a 9small amount= because the $ercent by eight of lo +acid food(s) in theli/uid is greater than 10 $ercent (see able ). ect to the re/uirements of 21 CFR $art 11 unless theli/uid is a carbonated be"erage (see 21 CFR 11 . (b)).

$. Decision tables and calculations for acid foods containing added lo,-acid foods


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e"aluating hether the amount of lo +acid food(s) in the finished $roduct is a 9small amount.=(As discussed in %ection .*. of this guidance, the recommendations for a$$lying the 9smallamount $ro"ision= do not a$$ly to ater+based li/uids, in hich the amount of ater is greater than the amount of all other ingredients combined).

he ecision ables and other recommendations in this guidance do not $reclude considerationof other factors relating to your $roduct or your manufacturing $rocess in determining hetheryour $roduct is an acid food containing small amounts of lo +acid food(s) in a s$ecific situation.f you determine that use of the ecision ables results in an ina$$ro$riate characteri3ation ofyour acid food containing added lo +acid food, you should $ro"ide F A ith formulation and

$rocess information to su$$ort your determination.


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Table ")ecommended Steps for Determining 8hether to valuate

9our (roduct Under the :Small Amount (rovision;

Step 4uestion Ans,er to the 4uestion


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Step 4uestion Ans,er to the 4uestion


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Table =)ecommended alculations for Determining 8hether to onsider the

Amount of +o,-Acid Food as a :Small Amount;8hen the


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Table >

1

)ecommendations for valuating the *uilibrium pH of the (redominant Acid or AcidFood 8hen the

Step 4uestion Ho, To Address the4uestion Ans,erto the4uestion


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Table ?

1E

)ecommendations for valuating the Finished *uilibrium pH of 9our (roduct 8hen the is to (roceed to Table ?

Step 4uestion Ho, To Address the4uestion Ans,er tothe4uestion


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Table 7)ecommendations for valuating 8hether the )esultant Finished *uilibrium pH of 9our(roduct Significantly Differs From That of the (redominant Acid or Acid Food 8hen the


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Step 4uestion Ho, To Address the4uestion

Ans,er tothe

4uestion


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Step 4uestion Ho, To Address the4uestion

Ans,er tothe

4uestion


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concerns $resented by fermented foods containing added lo +acid foods and $otential safetyconcerns $resented by acid foods containing added lo +acid foods. herefore, if you add a lo +acid food to a fermented food, e recommend that you e"aluate the $roduct using the ste$ ise

$rocess described in ecision ables 2 through # in section .*.5 of this document. o do so,you ould e"aluate a fermented food as if it ere an acid food, using the ste$s in these tables. f

the amount of lo +acid food(s) in your fermented food is not a 9small amount,= or if the resultantfinished e/uilibrium $* of your $roduct containing a small amount of lo +acid foodsignificantly differs from that of the fermented food, e recommend that you consider thefermented food to be an acidified food sub>ect to the re/uirements of 21 CFR 10 .25 and $art11 .

2. (rocessing Acidified Foods

#. Bac4ground on thermal processing

he ability of "egetati"e cells of microorganisms to gro in an acidified food, and of microbials$ores to germinate and gro in an acidified food, de$ends on a number of factors associatedith the food, such as its ater acti"ity, its $*, its redo; $otential

10 , the nature of any addedacid, and the $resence of antimicrobial substances (Ref. 5). icroorganisms that gro in anacidified food may ha"e significance for $ublic health, s$oilage, or both.

icroorganisms such as !. coli "#$%&'% , L. monoc togenes and almonella s$ecies ha"e $ublichealth significance. icroorganisms such as B. coagulans ha"e significance for s$oilage (Ref.1B). *o e"er, some microorganisms that are generally associated ith s$oilage, such as B.

subtilis and B. licheniformis , (Ref. 1B) can also affect the safety of an acidified food if s$ores thatare not destroyed during thermal $rocessing germinate, gro , and cause the $* to increase abo"e.# (Ref. E). herefore, destroying the s$ores of such s$oilage microorganisms is es$eciallyim$ortant in maintaining the food under conditions that ill not $ermit the gro th ofmicroorganisms ha"ing $ublic health significance hen $ermitted $reser"ati"es are not used to

$re"ent the gro th of any germinated s$ores.

he scientific and technical details su$$orting commercial thermal $rocessing of acidified foodsare a"ailable in a number of scientific >ournals (e.g., Refs. , 1 , and 1E) and in boo!s that area"ailable for $urchase (see, e.g., the boo!s e list in %ection M of this guidance). %uchscientific and technical details are beyond the sco$e of this guidance. *o e"er, in this guidancee summari3e some of the basic $rinci$les of thermal $rocessing, as discussed in Refs. 2 and 20through 22, and e;$lain technical terms associated ith thermal $rocessing.

A thermal $rocess for a $articular food $roduct is de"elo$ed based on the most heat+resistantmicroorganism that must be controlled in the food. he $* of the food $roduct is a $rinci$alfactor in determining the microorganism(s) that must be controlled in the food. For e;am$le, thethermal $rocess for a lo +acid food is de"elo$ed to ensure that the s$ores of C. botulinum aredestroyed. he thermal $rocess for an acidified food ith a $* in the range of .0 I .# is

10 he redo; $otential of a substance is a measurement of the ease by hich a substance gains or loseselectrons. For additional information about redo; $otential of foods, see Ref. .


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de"elo$ed to ensure that the s$ores of acid+tolerant s$oilage microorganisms (e.g., B.licheniformis ) are destroyed. he thermal $rocess for an acidified food ith a $* K .0 isde"elo$ed to ensure that the "egetati"e cells of yeasts, molds, and non+s$ore+forming bacteriasuch as Lactobacillus s$ecies are destroyed (Refs. 2 and 22).

After determining the most heat+resistant microorganism to control in a $articular food $roduct,one or more strains of the microorganism can be isolated and cultured to obtain "egetati"e cellsor s$ores in a sufficient number to enable an e;$erimental determination of the thermalresistance of the strain(s). n this determination, a !no n number of "egetati"e cells or s$ores issub>ected to a series of $rocesses ( ith s$ecified durations and tem$eratures), and the number of cells or s$ores sur"i"ing each $rocess is determined. he relationshi$ bet een the duration of athermal treatment and the $ercentage of microorganisms sur"i"ing the treatment is logarithmic,and the results of such studies are usually $resented in a $lot that re$resents the log of the $ercentof sur"i"ing "egetati"e cells or s$ores "ersus time at a gi"en tem$erature. he time re/uired todestroy E0 $ercent of the "egetati"e cells or s$ores at a gi"en tem$erature is called the decimalreduction time, usually referred to as the 9 +"alue= (Ref. 2). he +"alue usually "ariesin"ersely ith tem$erature.

n general, the slo$e of a $lot of the log of the +"alue "ersus tem$erature is a$$ro;imatelylinear. A 93+"alue= is deri"ed from the reci$rocal of the slo$e of the best straight line and ise/ual to the increase in the number of degrees (from a gi"en starting tem$erature) that results ina E0 $ercent reduction in the +"alue (Ref. 2). he +"alue and 3+"alue for the "egetati"e cellsor s$ores of a microbial strain at a s$ecified tem$erature characteri3e its thermal resistance atthat tem$erature. herefore, +"alues and 3+"alues $ro"ide a means to com$are the thermalresistance of different microorganisms, or different strains of the same microorganism, at one or more tem$eratures. able B, ada$ted from Refs. 2 and 22, ith additional information from Ref.1 , sho s a ty$ical com$arison of the heat resistance of se"eral microorganisms rele"ant to thesafety or s$oilage of thermally $rocessed foods.


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lass of Food

Type of 'icroorganism

'icroorganism0s1 )eferenceTemperature

0GF1

D-5alue0minutes1

@-5alue0GF1

-o +acidfood ($*J .#)

hermo$hiles a

(s$ores)Flat+sour grou$ ( B.

stearothermophilus )250 .0 I 5.0 1 +22

eso$hiles b

(s$ores)

8utrefacti"e

anaerobes ( C.botulinum ty$es Aand )

250 0.10 I 0.20 1 +1

C. sporogenesgrou$ (including8.A. #BE)

250 0.10 + 1.5 1 +1

Acid foodandacidifiedfood ($*.0 I .#)

hermo$hiles(s$ores)

B. coagulans(facultati"elymeso$hilic c)

250 0.01 I 0.0B 1 +1

eso$hiles(s$ores)

B. pol m +a and B.macerans

212 0.10 I 0.50 12+1#

utyric anaerobes(C. pasteurianum )

212 0.10 I 0.50 12+1#

B. licheniformis d 200 .5 2BAcid foodandacidifiedfood ($*K .0)

6easts, molds,and meso$hilicnon+s$ore+

bearing bacteria

Lactobacilluss$ecies,

Leuconostocs$ecies

150 0.50 I 1.00 +10

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Table

0ultima parte en laentrada de la lata a

proceso1omparative Heat )esistance of %acteria Important

to Thermally (rocessed Foods 0Adapted from )efs. " and ""1

a A thermo$hilic microorganism is one that thri"es at a relati"ely high tem$erature, such as 50 GCor abo"e.

b A meso$hilic microorganism is one that thri"es at a moderate tem$erature, such as B GC.c

A facultati"e microorganism is one that can li"e under more than one set of en"ironmentalconditions.d Ref. 1 .

Food $rocessors ty$ically com$are thermal treatments at "arious tem$eratures using a referencethermal treatment, referred to as an 9e/ui"alent treatment.= he e/ui"alent treatment isde"elo$ed for a reference tem$erature that is selected for the $ur$ose of conducting e;$erimentsto determine a$$ro$riate thermal $rocessing conditions. he reference tem$erature is selected

based on the heat resistance of microorganisms under $articular conditions of $* in general, thereference tem$erature is higher hen the microorganisms of interest are more heat+resistant. For


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Draft Not for Implementatione;am$le, the reference tem$eratures listed in able B for both thermo$hilic s$ores andmeso$hilic s$ores in lo +acid foods ( ith a $* greater than .#) is 250 GF. n contrast, thereference tem$eratures listed for meso$hilic s$ores in acid foods in the $* range .0 I .# are


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Finished :/uilibrium $* hermal 8rocess -ethality a

.1 I .2 F10'1E5 P 0.1 minutes b

. I .5 F10'1E5 P 1.0 minutes c

.5 I .0 F10'1E5 P 1#+2 minutes d

.0 I .2 F15'200 P 5.0 minutes e

. I . F15'200 P 2 minutes f

. I . F15'200 P 10 minutes e

. I . F15'212 P 10 minutes f

.5 I .# F15'212 P10 minutes g

.5 I .# F1 '2 0 P 1.# minutes g

2B



212 GF and 200 GF, and the reference tem$erature for yeasts, molds, and non+s$ore+formingmeso$hilic bacteria listed in able B is 150 GF. he destruction time at the reference tem$eraturefor a gi"en number of s$ecific microorganisms is designated 9F.= Additional information aboutho to do such com$arisons is a"ailable in Ref. 22.

he e;tent of thermal $rocessing (i.e., time and tem$erature) ade/uate to $re$are a commercialfood $roduct that is both safe and resistant to s$oilage is called the thermal $rocess lethality. herelationshi$ bet een the finished e/uilibrium $* of a $roduct and the thermal $rocess lethality isell established (e.g., Refs. , 1B, 1 and the boo!s e list in %ection M of this guidance). hethermal $rocess lethalities listed in able demonstrate this relationshi$. nformation about thes$ecific microorganisms and +"alues used to determine the thermal $rocess lethality isa"ailable in the cited references.

Table BThermal (rocess +ethalities for A cidified Foods

a :;$ressed as F3'Ref, here F is the destruction time, 3 is the increase in tem$erature that

results in a E0 $ercent reduction in the +"alue, and Ref is the reference tem$erature (see thediscussion in %ection . .1 of this guidance for further information about the designations F, 3+"alue, and +"alue).

b %ee, e.g., Ref. .c %ee, e.g., elson 8, and ressler . 1E 0. Fruit and 5egetable 6uice 7rocessing echnolog .


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2



containers and closures), or both. elo , e describe the t o most common methodologies(Ref. 21) for $rocessing an acidified food.

H he $roduct may be heated in a bul! container to a $re+determined tem$erature, held atthat tem$erature for a $re+determined $eriod of time to achie"e thermal $rocess lethality,filled into containers, and closed (e.g., under steam "acuum). hermal $rocessing of the

containers and closures is accom$lished by rotating, tilting, or in"erting the filled, sealedcontainers to bring all sections of the containers and closures (ca$s or lids) in contactith hot $roduct. his ty$e of $rocess is often referred to as 9hot fill and hold.=

H he $roduct may be filled into containers and sealed. he thermal $rocessing to achie"ethermal $rocess lethality at a $re+determined tem$erature for a $re+determined time ta!es

$lace in the filled and sealed containers. his $rocedure usually ta!es $lace incommercially a"ailable $rocessing e/ui$ment. hermal $rocessing of the containers andclosures occurs simultaneously ith the thermal $rocessing of the $roduct.

*. Competent processing authorit

%ection 21 CFR 11 . (e) re/uires that the control of $* and other critical factors for a scheduled $rocess for an acidified food be e/ui"alent to the $rocess established by a com$etent $rocessingauthority. he full range of critical factors that a com$etent $rocessing authority ould consider in establishing a scheduled $rocess is outside the sco$e of this guidance. Follo ing therecommendations in this guidance does not necessarily satisfy the re/uirement of 21 CFR 11 . (e) that your scheduled $rocess be e/ui"alent to that established by a com$etent $rocessingauthority.

. Challenge studies

he scientific and technical data su$$orting scheduled $rocesses established o"er time bycom$etent $rocessing authorities are a"ailable in a number of scientific >ournals (e.g., Refs. , 1and 1E) and in boo!s that are a"ailable for $urchase (see, e.g., the boo!s e list in %ection M ofthis guidance). f a ne scheduled $rocess is being established and ade/uate scientific su$$ortfor the scheduled $rocess is not a"ailable, e recommend that data and information froma$$ro$riate challenge studies be de"elo$ed for consideration by the com$etent $rocessingauthority ho ill establish the ne scheduled $rocess. he challenge studies shoulddemonstrate that one or more critical factors (or combinations of critical factors) such as $*,tem$erature, or storage time satisfy the re/uirements of 21 CFR 11 . 0(a) (e.g., Refs. 1 , and 2through 25).

8rocesses using ambient tem$erature as one of a combination of critical factors ha"e beenre$orted in the scientific literature (Ref. 1 ). he ambient tem$eratures studied include thoseli!ely to be associated ith a food $rocessing facility (such as 25 GC) and those li!ely to beassociated ith a arehouse in a cool climate (such as 10 GC). f one of the critical factorsre$orted in a scheduled $rocess filed under 21 CFR 10 .25 is an ambient tem$erature, e illconsider hether using the ambient tem$erature as a critical factor satisfies the re/uirements of 21 CFR 11 . (e) and 11 . 0(a) based on the a"ailable data and information $ro"ided ith the

$rocess filing.


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2E



/. 7otential for microbial contamination from pac4aging

8ac!aging such as containers and lids can be a source of microbiological contamination. hecom$etent $rocessing authority should consider the $otential for such contamination hende"elo$ing a scheduled $rocess.

$. 9de1uac of the cheduled 7rocess

he scheduled $rocess for acidified foods&H s the $rocess selected by a $rocessor as ade/uate for use under the conditions of

manufacture for a food in achie"ing and maintaining a food that ill not $ermit thegro th of microorganisms ha"ing $ublic health significance (see 21 CFR 11 . (e)), and

H ust be sufficient to destroy the "egetati"e cells of microorganisms of $ublic healthsignificance (see 21 CFR 11 . 0(a)(1)) and

H ust be sufficient to destroy the "egetati"e cells of microorganisms of nonhealthsignificance ca$able of re$roducing in the food under the conditions in hich the food isstored, distributed, retailed, and held by the user (see 21 CFR 11 . 0(a)(1)).

o be ade/uate in achie"ing and maintaining a food that ill not $ermit the gro th ofmicroorganisms ha"ing $ublic health significance, the scheduled $rocess should be sufficient todestroy s$ores of those microorganisms of nonhealth significance ca$able of germinating andre$roducing and increasing the $* of acidified foods abo"e .#, unless $ermitted $reser"ati"esare used to $re"ent the gro th of the microorganisms of non+health significance in lieu ofthermal $rocessing.

o be ade/uate in destroying the "egetati"e cells of microorganisms of $ublic healthsignificance, the scheduled $rocess for acidified foods should be sufficient to destroy or $re"entthe $resence of "egetati"e cells of $athogenic microorganisms, including $athogenic

microorganisms (such as !. 15B&*B, L. monoc togenes and almonella s$ecies) that are acid+tolerant but do not $roduce s$ores.

@nder 21 CFR 10 .25(c)( )(ii), e may re/uest that a $rocessor $ro"ide information e deemnecessary to determine the ade/uacy of the $rocess. Consistent ith 21 CFR 11 . (b) and11 . 0(a)(1), the re/uested information may include information related to&

H Ade/uacy of the $rocess to destroy "egetati"e cells of microorganisms, includingmicroorganisms of $ublic health significance and microorganisms of nonhealthsignificance and

H Ade/uacy of the $rocess to destroy s$ores of microorganisms ca$able of germinatingand re$roducing and increasing the $* of acidified foods abo"e .#.

3. 4uality ontrol (rocedures to Address Spoilage

@nder 21 CFR 11 . 0(a), you must em$loy a$$ro$riate /uality control $rocedures to ensure thatfinished foods do not $resent a health ha3ard.


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0



H e"elo$ing and im$lementing a ritten $lan to systematically in"estigate manufacturedlots for signs of s$oilage

H 8rom$tly and thoroughly in"estigating the cause of any s$oilageH 8rom$tly ta!ing correcti"e actions if s$oilage occurs andH ocumenting any in"estigation and correcti"e actions rele"ant to s$oilage.

I5. 6amples of %oo&s Available for (urchase1. %tumbo CR. 1EB . hermobacteriolog In Food 7rocessing . e 6or!& Academic 8ress.

2. -arousse D, and ro n . 1EEB. Food Canning echnolog . e 6or!&


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1



. dlaug :, and 8flug D. 1EB . Clostridium Botulinum and Acid Foods. 6ournal of Food 7rotection 1 (B)& 5##+5B .

5. nstitute of Food echnologists. 2001. :"aluation and efinition of 8otentially *a3ardous

Foods. Cha$ter . F 'F A Contract o. 22 +E +2 .

#. ont"ille . 1E 2. etabiotic effect of Bacillus licheniformis on Clostridium botulinum &m$lications for *ome Canned omatoes. 9pplied and !n2ironmental 8icrobiolog (2)& +.

B. 6oung+8er!ins O, and erson R. 1E B. Clostridium botulinurn %$ore 7ermination,utgro th, and o;in 8roduction elo $* .# nteractions et een $*, otal Acidity, anduffering Ca$acity. 6ournal of Food cience 52 ( )& 10 +10 .

. Al u>aili D, and Anderson R:. 1EE1. Aciduric, $*+:le"ating Bacillus hich Cause

oneffer"escent %$oilage of @nder$rocessed omatoes. 6ournal of Food cience 5# (#)& 1#11+1#1 .

E. Rodrigue3 D, Cousin , and elson 8. 1EE2. :"aluation of anaerobic gro th of Bacilluslicheniformis and Bacillus subtilis in tomato >uice. 6ournal of Food 7rotection E& #B2+#BB.

10. Centers for isease Control and 8re"ention. 1EE#. utbrea! of !scherichia coli 15B&*Binfections associated ith drin!ing un$asteuri3ed commercial a$$le >uice++ ritish Columbia,California, Colorado, and uices. Crit. Re2 8icrobiol. 2 (2)&10E+11E.

12. Centers for isease Control and 8re"ention. 1EEE. utbrea! of almonella seroty$euenchen infections associated ith un$asteuri3ed orange >uice++@nited %tates and Canada,Dune 1EEE. 880R. 8orb. 8ortal. 04l . Rep (2B)& 5 2+5 5.

1 . reidt F, Dr., *ayes D%, sborne DA, and cFeeters RF. 2005. etermination of 5+log $athogen reduction times for heat+$rocessed, acidified "egetable brines. 6 Food 7rot. # (2)&05+ 10.

1 . reidt F, Dr., *ayes D, and cFeeters RF. 200B. etermination of 5+log reduction times for food $athogens in acidified cucumbers during storage at 10 and 25 degrees C. 6 Food 7rot. B0(11)& 2# +2# 1.

15. @.%. Food and rug Administration. :stabli s h m ent Regi s t r a tion and 8 r ocess Filing .

1#. @.%. Food and rug Administration. nstructions for :stablish m ent Registration and8rocessing Filing for Acidified and -o +A c id Canned Foods. able of Contents. 1EEB.
http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm094145.htmhttp://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm094145.htmhttp://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm094145.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/default.htmhttp://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm094145.htmhttp://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm094145.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/default.htmhttp://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/default.htm


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2



1B. ro n O-. 2000. Control of bacterial s$ores. Br 8ed Bull 5# (1)& 15 +1B1.

1 . ont"ille , and %a$ers 7. 1E 1. hermal resistance of s$ores from $* ele"ating strains of Bacillus licheniformis . 6ournal of Food cience #& 1B10+1B12.

1E. Rodrigo , artine3 A, %anchis D, rama D, and 7iner M. 1EE0. etermination of *ot+Fill+*old+Cool 8rocess %$ecifications for Crushed omatoes. 6ournal of Food cience 55 ( )& 102E+10 2.

20. -arousse D, and ro n . 1EEB. *eat 8enetration in Canned Foods + heoreticalConsiderations. n Food Canning echnolog , eds D -arousse and ro n, + 2 . e6or!&


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H :"aluate the $roduct based on the characteristics of its ingredients.o he ingredients ith a $* of .# or belo are all acidified foodso he $roduct has a finished e/uilibrium $* of .# or beloo he ater acti"ity of tomatoes is greater than 0. 5

H 6ou should consider that your $roduct is C M:R: by 21 CFR $art 11 .

)*ample .: Tomato Salsa ,anufactured by Company /H escri$tion of $roduct&

o 8rocessed tomatoes (acidified to $* .0)o Fresh onions, garlic, and green $e$$erso %alt, s$iceso Finished e/uilibrium $*& .1.

H able 2, %te$ A& one of the ingredients are acid foods the ingredients ith a $* of .#or belo are all acidified foods.

H % 8 e"aluating hether the $roduct is an acid food containing small amounts of lo +acid food(s). 6ou should consider that your $roduct&

o s an acid food containing small amounts of lo +acid food(s) ando ay be C M:R: by 21 CFR $art 11 .

H :"aluate the $roduct based on the characteristics of its ingredients.o he ingredients ith a $* of .# or belo are all acidified foodso he $roduct has a finished e/uilibrium $* of .# or beloo he ater acti"ity of tomatoes is greater than 0. 5

H 6ou should consider that your $roduct is C M:R: by 21 CFR $art 11 .

)*ample 0: Tomato Salsa ,anufactured by Company C H escri$tion of $roduct&

o A "ariety of "ine+ri$ened fresh tomatoes that naturally has a $* of .o Fresh onions, garlic, and green $e$$erso %alt, s$iceso Finished e/uilibrium $*& .5.

H able 2, %te$ A& he $roduct contains an acid food (tomatoes ith a natural $* of . ).8R C:: to %te$ .

H able 2, %te$ & he $roduct contains lo +acid ingredients (fresh onions, garlic, green $e$$ers, salt, and s$ices). 8R C:: to %te$ C.

H able 2, %te$ C& he finished e/uilibrium $* of the $roduct is belo .#. 8R C:: to%te$ .

H able 2, %te$ & he $roduct is not a ater+based li/uid. 8R C:: to %te$ :.H able 2, %te$ :& one of the listed e;clusions (for ater acti"ity, carbonated be"erage,

or refrigeration) a$$ly. 8R C:: to %te$ F.H able 2, %te$ F& he $roduct does not contain any acidified foods. 8R C:: to able

.H able , %te$ 7&

o he eight of all acid ingredients (fresh tomatoes) is 0 $oundso he eight of all lo +acid ingredients (fresh onions, garlic, $e$$ers, salt, and

s$ices) is 20 $ounds


37/40



o he total eight of all ingredients is 500 $oundso he $ercent of lo +acid ingredients is $ercent (20 $ounds'500 $ounds) I i.e.,

less than 10 $ercent.o 8R C:: to able .

H able , %te$ *& he $redominant acid food is fresh tomatoes the $* of this "ariety of

fresh tomatoes is . , i.e., greater than .2.H % 8& 6ou should consider the $roduct to be C M:R: by 21 CFR $art 11 .

)*ample ": -pplesauce ,ade from 1resh ,cIntosh -pples and 1resh Dates% ,anufacturedby Company D

H escri$tion of $roduct&o Fresh c ntosh a$$les (natural $* of . )o Fresh dates (natural $* of .B)o Finished e/uilibrium $*& .5.

H able 2, %te$ A& he $roduct contains an acid food (fresh a$$les). 8R C:: to %te$ .H able 2, %te$ & he $roduct contains a lo +acid ingredient (fresh dates). 8R C:: to

%te$ C.H able 2, %te$ C& he finished e/uilibrium $* of the $roduct is belo .#. 8R C:: to

%te$ .H able 2, %te$ & he $roduct is not a ater+based li/uid. 8R C:: to %te$ :.H able 2, %te$ :& one of the listed e;clusions (for ater acti"ity, carbonated be"erage,


.H able , %te$ 7&

o he eight of all acid ingredients (fresh a$$les) is E0 $oundso he eight of all lo +acid ingredients (fresh dates) is 10 $oundso he total eight of all ingredients is 500 $oundso he $ercent of lo +acid ingredients is 2 $ercent (10 $ounds'500 $ounds) I i.e.,

less than 10 $ercent.o 8roceed to able .

H able , %te$ *& he $redominant acid food is a$$les the $* of the fresh a$$les is . ,i.e., less than .2. 8R C:: to able 5.

H able 5, %te$ & he finished e/uilibrium $* of the a$$lesauce ith added fresh dates is.5, i.e., less than . . 8R C:: to able #.

H able #, %te$ D& he e/uilibrium $* of the $redominant acid food (fresh a$$les) is K . .8R C:: to %te$ -.

H able #, %te$ -& he shift in $* is 0.1 ( .5 I . ), hich is K 0. . 6ou should considerthat&

o he resultant finished e/uilibrium $* of your $roduct does not differ significantlyfrom that of the $redominant acid food and

o 6our $roduct is :NC-@ : from the co"erage of 21 CFR $art 11 .

)*ample 2: -pplesauce ,ade from 1resh ,cIntosh -pples and 1resh Dates% ,anufacturedby Company )


38/40

5



H escri$tion of $roduct&o Fresh c ntosh a$$les (natural $* of . )o Fresh dates (natural $* of .B)o Finished e/uilibrium $*& .B.

H able 2, %te$ A& he $roduct contains an acid food (fresh a$$les). 8R C:: to %te$ .H

able 2, %te$ & he $roduct contains a lo +acid ingredient (fresh dates). 8R C:: to%te$ C.

H able 2, %te$ C& he finished e/uilibrium $* of the $roduct is less than .#. 8R C::to %te$ .



.H able , %te$ 7&

o he eight of all acid ingredients (fresh a$$les) is 0 $oundso he eight of all lo +acid ingredients (fresh dates) is #0 $oundso he total eight of all ingredients is 500 $oundso he $ercent of lo +acid ingredients is 12 $ercent (#0 $ounds'500 $ounds) I i.e.,

greater than 10 $ercent.H % 8. 6ou should consider that&

o he amount of lo +acid food is not a small amount ando 6our $roduct is C M:R: by 21 CFR $art 11 .

)*ample 3: -pplesauce ,ade from 1resh Delicious -pples a n d 1resh 1igs% ,anufactured byCompany 1

H escri$tion of $roduct&o Fresh elicious a$$les (natural $* of .E)o Fresh figs (natural $* of 5.B)o Finished e/uilibrium $*& . .

H able 2, %te$ A& he $roduct contains an acid food (fresh a$$les). 8R C:: to %te$ .H able 2, %te$ & he $roduct contains a lo +acid ingredient (fresh figs). 8R C:: to

%te$ C.H able 2, %te$ C& he finished e/uilibrium $* of the $roduct is less than .#. 8R C::

to %te$ .H able 2, %te$ & he $roduct is not a ater+based li/uid. 8R C:: to %te$ :.H able 2, %te$ :& one of the listed e;clusions (for ater acti"ity, carbonated be"erage,


.H able , %te$ 7&

o he eight of all acid ingredients (fresh a$$les) is 50 $oundso he eight of all lo +acid ingredients (figs) is 50 $oundso he total eight of all ingredients is 500 $oundso he $ercent of lo +acid ingredients is 10 $ercent (50 $ounds'500 $ounds).


39/40

#



o 8roceed to able .H able , %te$ *& he $redominant acid food is a$$les the $* of the fresh a$$les is .E,

i.e., less than .2. 8R C:: to able 5.H able 5, %te$ & he finished e/uilibrium $* of the a$$lesauce ith added figs is . ,

i.e., less than . . 8R C:: to able #.H

able #, %te$ D& he e/uilibrium $* of the $redominant acid food (fresh a$$les) is .E,i.e., . or more and less than .2. 8R C:: to %te$ O.

H able #, %te$ O& he shift in $* is 0. ( . I .E), hich is J 0. . 6ou should considerthat&

o he resultant finished e/uilibrium $* of your $roduct differs significantly fromthat of the $redominant acid food and

o 6our $roduct is C M:R: by 21 CFR $art 11 .

)*ample 4: /arbecue Sauce ,anufactured by Company G H escri$tion of $roduct&

o Minegar ($* of 2.5)o omato $aste ($* of .0)o *igh fructose corn syru$, modified food starch, molasses, s$ices, and fla"orso :/uilibrium $* of the mi;ture of "inegar and tomato $aste& .0o Finished e/uilibrium $*& .B.

H able 2, %te$ A& he $roduct contains an acid ("inegar) and an acid food (tomato $aste).8R C:: to %te$ .

H able 2, %te$ & he $roduct contains lo +acid ingredients (high fructose corn syru$,modified food starch, molasses, s$ices, and fla"ors). 8R C:: to %te$ C.

H able 2, %te$ C& he finished e/uilibrium $* of the $roduct is less than .#. 8R C::to %te$ .



.H able , %te$ 7&

o he eight of all acid ingredients (fresh a$$les) is 50 $oundso he eight of all lo +acid ingredients (high fructose corn syru$, modified food

starch, molasses, s$ices, and fla"ors) is 50 $oundso he total eight of all ingredients is 500 $oundso he $ercent of lo +acid ingredients is 10 $ercent (50 $ounds'500 $ounds).o 8roceed to able .

H able , %te$ *& he $redominant acid or acid food is the mi;ture of "inegar and tomato $aste. he $* of the mi;ture is .0, i.e., less than .2. 8R C:: to able 5.

H able 5, %te$ & he finished e/uilibrium $* of the barbecue sauce is .B, i.e., less than. . 8R C:: to able #.

H able #, %te$ D& he e/uilibrium $* of the $redominant acid or acid food (mi;ture of"inegar and tomato $aste) is .0, i.e., less than . . 8R C:: to %te$ -.

H able #, %te$ -& he shift in $* is 0.B ( .B I .0), i.e., J 0. . 6ou should consider that&


40/40



o he resultant finished e/uilibrium $* of your $roduct differs significantly fromthat of the $redominant acid food and

o 6our $roduct is C M:R: by 21 CFR $art 11 .

Documents

Guidance Acidificado