6/9/2014 Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)

http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/MicroorganismsMicrobialDerivedIngredients/default.htm 1/5
Microorganisms&MicrobialDerivedIngredientsUsedinFood
(PartialList)

Foodingredientsmaybe"foodadditives"thatareapprovedbyFDAfor
specificusesorGRAS(generallyrecognizedassafe)substances.A
substancemaybeGRASonlyifitsgeneralrecognitionofsafetyisbasedon
theviewsofexpertsqualifiedtoevaluatethesafetyofthesubstance.GRAS
statusmaybebasedeitheronahistoryofsafeuseinfoodpriorto1958or
onscientificprocedures,whichrequirethesamequantityandqualityof
evidenceaswouldberequiredtoobtainafoodadditiveregulation.Because
GRASstatusmaybeeitheraffirmedbyFDAordeterminedindependentlyby
qualifiedexperts,FDA'sregulationsdonotincludeallGRASingredientsand
thespecificusesdescribedintheGRASregulationsmaynotbe
comprehensiveforthelistedingredients.
Thelistbelowincludessomeingredientsthatarenotlistedin21CFRbut
havebeenthesubjectofopinionlettersfromFDAtoindividualswhoasked
whetherFDAwouldobjecttotheuseoftheingredientinfoodonthebasis
ofanindependentGRASdetermination.Becausethelistisnotupdatedona
regularbasis,questionsabouttheregulatorystatusofmicroorganismsor
microbialderivedingredientsthatarenotonthislistmaybedirectedtous
viaelectronicmailatPremarkt@fda.hhs.gov
Thefollowinglist,whichderivespartiallyfromFDA'sregulationsinTitle21
oftheCodeofFederalRegulations(21CFR),includesapprovedfood
additives,substanceswhoseGRASstatushasbeenaffirmedbyFDAand
substancesthatFDAlistedasGRASbasedonahistoryofsafeuseinfood.
Inaddition,microorganismsandmicrobialderivedingredientsmaybethe
subjectofaGRASnotice.Forfurtherinformation,consultthesummary
listingofGRASingredients.
ThefollowingisacompilationoffoodadditiveslistedinTitle21oftheCode
ofFederalRegulations(21CFR)Part172and173,whicharederivedfrom
microorganisms.Thislistalsoincludesseaweedsources.Conditionsfor
theiruseareprescribedinthereferentregulationsandarepredicatedon
theuseofgoodmanufacturingpractices.
Toaccessthespecificregulationslistedbelow,typeinthetitlenumber,use
thelinksbelowtoaccesstheGovernmentPrintingOfficewebsite.
Table1.FoodAdditivesDerivedfromMicroorganismslistedin21CFR172
and173
Regulation
in21CFR
Ingredient
172.155
NatamycinderivedfromStreptomycesnatalensisand
Streptomyceschattanoogensis
172.325 BakersyeastproteinderivedfromSaccharomycescerevisiae
172.590
Yeastmaltsproutextract,derivedfromSaccharomyces
cerevisiae,Saccharomycesfragilis,Candidautilis
172.620
Carrageenan,ahydrocolloidextractedfromthefollowing
membersofthefamiliesGigartinaceaeandSoliericeaeofthe
classRodophyceae(redseaweed):Chondruscrispus,Chondrus
ocellatus,Eucheumacottonii,Eucheumaspinosum,Gigartina
Food
Home Food Ingredients, Packaging & Labeling Generally Recognized as Safe (GRAS) Microorganisms & Microbial
Derived Ingredients Used in Food
6/9/2014 Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)
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acicularis,Gigartinapistillata,Gigartinaradula,Gigartina
stellata
172.655
Furcelleran,therefinedhydrocolloidextractedfromFurcellaria
fastigiataoftheclassRodophyceae(redseaweed)
172.695 XanthanGumderivedfromXanthomonascampestris
172.725
GibberellicacidderivedbyfermentationfromFusarium
moniliforme
172.896
Driedyeasts,Saccharomycescerevisiae,Saccharomyces
fragilis,anddriedtorulayeast,Candidautilis
172.898 BakersyeastglycanfromSaccharomycescerevisiae
173.110
AmyloglucosidasederivedfromRhizopusniveusforusein
degradinggelatinizedstarchintoconstituentsugars
173.120
CarbohydraseandcellulasederivedfromAspergillusnigerfor
useinclamandshrimpprocessing
173.130
CarbohydrasederivedfromRhizopusoryzaeforuseinthe
productionofdextrosefromstarch
173.135
CatalasederivedfromMicrococcuslysodeikticusforuseinthe
manufactureofcheese
173.140
EsteraselipasederivedfromMucormieheivar.Cooneyet
Emersonasaflavorenhancerincheeses,fatsandoils,and
milkproducts
173.145
AlphagalactosidasederivedfromMorteirellavinaceaevar.
raffinoseutilizerforuseintheproductionofsucrosefromsugar
beets
173.150
Milkclottingenzymes,microbialforuseintheproductionof
cheese(MilkclottingenzymesarederivedfromEndothia
parasitica,Bacilluscereus,MucorpusillusLindtandMucor
mieheiandAspergillusoryzaemodifiedtocontainthegenefor
asparticproteinasefromRhizomucormieheivarCooneyet
Emerson
173.160
Candidaguilliermondiiastheorganismforfermentation
productionofcitricacid
173.165 Candidalipolyticaforfermentationproductionofcitricacid.
173.280
Asolventextractionprocessforrecoveryofcitricacidfrom
Aspergillusnigerfermentationliquor
ThefollowingisacompilationofGRASaffirmedsubstanceslistedin21CFR
part184whicharederivedfrommicroorganisms.Thislistalsoincludes
seaweedsources.Conditionsfortheiruseareprescribedinthereferent
regulationsandarepredicatedontheuseofnonpathogenicand
nontoxicogenicstrainsoftherespectiveorganismsandontheuseof
currentgoodmanufacturingpractice(184.1(b)).Pleasebeawarethatnot
allGRASsubstanceshavebeenrecordedassuchandsothisdoesnot
representacompletelistofallmicrobialderivedGRASfoodingredients.
Table2.SubstancesDerivedfromMicroorganismsAffirmedbyFDAas
GenerallyRecognizedasSafein21CFR184
Section
in21CFR
IngredientorSubstance
184.1005Aceticacidmaybeproducedbyfermentation
184.1011Alginicacidmadefromcertainbrownalgae
184.1012
AlphaamylaseenzymepreparationfromBacillus
stearothermophilususedtohydrolyzeediblestarchtoproduce
maltodextrinandnutritivecarbohydratesweeteners.
184.1027
Mixedcarbohydraseandproteaseenzymeproductderivedfrom
Bacilluslicheniformisforuseinhydrolyzingproteinsand
carbohydratesinthepreparationofalcoholicbeverages,candy,
nutritivesweetenersandproteinhydrolysates
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184.1061Lacticacidmaybeproducedbyfermentation
184.1081Propionicacidfrombacterialfermentation
184.1115
Agaragar,extractedfromanumberofrelatedspeciesofred
algaeclassRhodophyceae
184.1120
Brownalgae,tobeuseddriedasaflavorenhancer,are
seaweedsofthespecies:Analipusjaponicus,Eiseniabicyclis,
Hizikiafusiforme,Kjellmaniellagyrata,Laminariaangustata,
Laminarialongirruris,LaminariaLongissima,Laminaria
ochotensis,Laminariaclaustonia,Laminariasaccharina,
Laminariadigitata,Laminariajaponica,Macrocystispyrifera,
Petaloniafascia,Scytosiphonlome
184.1121
Redalgae,tobeuseddriedasaflavorenhancer,areseaweeds
ofthespecies:Gloiopeltisfurcata,Porphyracrispata,Porhyra
deutata,Porhyraperforata,Porhyrasuborbiculata,Porphyra
tenera,Rhodymenispalmata
184.1133Ammoniumalginatefromcertainbrownalgae
184.1187Calciumalginatefromcertainbrownalgae
184.1318
Gluconodeltalactone,byoxidationofDglucoseby
microorganismsthatarenonpathogenicandnontoxicogenicto
manorotheranimals.Theseincludebutarenotrestrictedto
AspergillusnigerandAcetobactorsuboxydans
184.1372
Insolubleglucoseisomeraseenzymepreparationsarederived
fromrecognizedspeciesofpreciselyclassified,nonpathogenic,
andnontoxicogenicmicroorganisms,includingStreptomyces
rubiginosus,Actinoplanemissouriensis,Streptomycesolivaceus,
Streptomycesolivochromogenes,andBacilluscoagulansgrown
inapureculturefermentationthatproducesnoantibiotic
184.1387
LactaseenzymepreparationfromCandidapseudotropicalisfor
useinhydrolyzinglactosetoglucoseandgalactose
184.1388
LactaseenzymepreparationfromKluyveromyceslactis
(previouslycalledSaccharomyceslactis)foruseinhydrolyzing
lactoseinmilk
184.1420
LipaseenzymepreparationfromRhizopusniveususedinthe
interesterficationoffatsandoils.
184.1538
NisinpreparationfromLactococcuslactisLancefieldGroupNfor
useasanantimicrobialagenttoinhibittheoutgrowthof
Clostridiumbotulinumsporesandtoxinformationinpasteurized
cheesespreads.
184.1610
Potassiumalginate,thepotassiumsaltofalginicacid,derived
fromcertainbrownalgae
184.1685
Rennet(animalderived)andchymosinpreparationfrom
EscherichiacoliK12,Kluyveromycesmarxianusvar.lactisor
Aspergillusnigervar.awamoritocoagulatemilkincheesesand
otherdairyproducts
184.1695RiboflavinbiosynthesizedbyEremotheciumashbyii
184.1724
Sodiumalginate,thesodiumsaltofalginicacid,derivedfrom
certainbrownalgae
184.1848
ButterstarterdistillatefrommilkculturesofStreptococcus
lactis,Streptococcuscremoris.Streptococcuslactissubspecies
diacetylactis,Leuconostoccitovorum,Leuconostocdextranicum
184.1924
UreaseenzymepreparationfromLactobacillusfermentumfor
useintheproductionofwine
184.1945VitaminB12fromStreptomycesgriseus
184.1950
VitaminD,producedbyultravioletirradiationofergosterol
isolatedfromyeastandrelatedfungi
184.1983BakersYeastextractfromSaccharomycescerevisiae
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184.1985
AminopeptidaseenzymepreparationfromLactococcuslactis
usedasanoptionalingredientforflavordevelopmentinthe
manufactureofcheddarcheese.
ThefollowingGRASaffirmedsubstancesarelistedin21CFRPart186and
areaffirmedforuseassubstancesaddedindirectlytofood.Conditionsfor
theiruseareprescribedinthereferentregulationsandarepredicatedon
theuseofnonpathogenicandnontoxicogenicstrainsoftherespective
organismsandontheuseofcurrentgoodmanufacturingpractice
(186.1(b)).
Table3.SubstancesDerivedfromMicroorganismsAffirmedbyFDAas
GenerallyRecognizedasSafeforIndirectUsesin21CFR186
Section
in21CFR
Substance
186.1275
Dextrans,madebyfermentationofsucrosebyLeuconostoc
mesenteroidesstrainNRRLB512(F)
186.1839
Sorbose,madebyoxidationofsorbitolbyAcetobacterxylinum
orbyAcetobactersuboxydans
ThefollowingisacompilationofmicrobialderivedenzymeswhichtheFDA
recognizedasGRASinopinionlettersissuedintheearly1960's.The
opinionsarepredicatedontheuseofnonpathogenicandnontoxicogenic
strainsoftherespectiveorganismsandontheuseofcurrentgood
manufacturingpractice.
Table4.SubstancesDerivedfromMicroorganismsRecognizedbyFDAas
GenerallyRecognizedasSafeinOpinionLetters
Enzyme
Carbohydrase,cellulase,glucoseoxidasecatalase,pectinase,andlipase
fromAspergillusniger
CarbohydraseandproteasefromAspergillusoryzae
CarbohydraseandproteasefromBacillussubtilis
Invertasefromediblebaker'syeastorbrewer'syeast(Saccharomyces
cerevisiae)
Thefollowingisacompilationoffoodsforhumanconsumptionlistedin21
CFRParts131,133,136and137thatmaycontainorbederivedfrom
microorganisms.
Table5.Foodsforhumanconsumptionthatmaycontainorbederivedfrom
microorganismslistedin21CFRParts131,133,136,and137
Section
in21
CFR
StandardizedFood
131.111
Acidifiedmilk,withorwithouttheadditionofcharacterizing
microbialorganisms,andaromaandflavorproducing
microbialculture.Conditionsfortheiruseareprescribedinthe
referentregulations
131.200
YogurtmadebythelacticacidproducingbacteriaLactobacillus
bulgaricusandStreptococcusthermophilus
131.106
Bluecheese,characterizedbythepresenceofthemold
Penicilliumroquefortii
133.113
Cheddarcheese,subjectedtotheactionofalacticacidproducing
bacterialcultureandclottingenzymesofanimal,plantor
microbialoriginusedincuringorflavordevelopment
136.110
Bread,rolls,andbunsmaycontainasoptionalingredientslactic
acidproducingbacteria
137.105
Flourmaycontainalphaamylaseobtainedfromthefungus
Aspergillusoryzae
Priorsanctionsweregrantedfortheuseofharmlesslacticacidproducing
bacteria,suchasLactobacillusacidophilus,asoptionalingredientsin
6/9/2014 Microorganisms & Microbial-Derived Ingredients Used in Food (Partial List)
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specifiedstandardizedfoods.Thesebacteriaarepermittedforusein
culturedmilk(whichincludesbuttermilk)(131.112),sourcream(
131.160),cottagecheese(133.128),andyogurt(131.200),provided
thatthemandatoryculturesofLactobacillusbulgaricusandStreptococcus
thermophillusarealsousedintheyogurt.
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