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NITRATEandNITRITE
Intakeassessment
Firstdraftpreparedby
T.Hambridge
AustraliaNewZealandFoodAuthority,Canberra,Australia
Introduction
Concentrationsinfoods
Assessmentsofintake
Intakefromsourcesotherthanfoodadditives
Intakefromuseasafoodadditive
Intakefromallsources
Intakereportedintheliterature
Evaluationofestimatesofintake
Intakefromsourcesotherthanfoodadditives
Intakefromuseasafoodadditive
Intakefromallsources
Conclusionsandrecommendations
Generalrecommendation
RecommendationstotheCodexCommitteeon
FoodAdditivesandContaminants
References
1.INTRODUCTION
Nitrateandnitritearefoundnaturallyintheenvironment,andformpartofthenitrogencycle.Nitrateisformedfromoxidationoforganicwastesbytheactionof
nitrogenfixingbacteria.Thenitriteionisrelativelyunstableandisreadilyoxidizedtonitrate.Nitrateandnitritearealsofoundinsoilandwaterduetouseoffertilizers
(WHO,1998a).Nitratehasbeenshowntobeproducedendogenously(McKnightetal.,undated).Itisactivelysecretedintosaliva,wheresomeisreducedtonitriteby
oralmicroflora(Dichetal.,1996WHO,1998a).Salivarynitrateisswallowedandrecirculated.Nitrateisalsofoundinair,atconcentrationsof0.10.4g/m3,although
concentrationsupto40g/m3havebeenreported(WHO,1998a).
Nitrateisfoundnaturallyinfoodsandinhighconcentrationsincertainvegetables.Theconcentrationsinvegetablesdependonanumberoffactorsincludingseason,
light,temperature,methodofgrowth,fertilizeruseandstorage(Dichetal.,1996).InEurope,theconcentrationsofnitratearegenerallyhigherinwinter(European
Commission,1998)owingtothelowlightintensityandfewerdaylighthours.
Nitrateandnitritearealsousedasfoodadditivesinprocessedfoods,aspreservatives,antimicrobialagentsandcolourfixatives(Tompkin,1993InstituteofMedicine,
1996).Themainprocessedfoodsinwhichitisusedincludecuredmeat,poultryandfish,otherprocessedmeatsandcheese(Coultate,1989Tompkin,1993Maga&Tu,
1995).
NitrateispermittedforuseintheCodexdraftGeneralStandardforFoodAdditives(GSFA)innumerousfoodcategories,includingcheeseandcheeseproducts,rawand
processedmeats,ediblecasings,processedfishandfishproductsandspiritsandliqueurs.TheGSFAalsopermitsuseofnitriteinnumerousfoodcategories,including
cheeseandcheeseproducts,meatandprocessedmeats,ediblecasings,cookedandpreservedfishandroe.
Ideally,allsourcesofnitrateandnitriteshouldbeconsideredinordertodeterminetotalestimatedintakeandtheriskstohealthhowever,onlytheintakefromfood(non
additivesourcesandasafoodadditive)andwaterareconsideredbelow.
TheADIfornitrateof03.7mg/kgbw,expressedasnitrateion,wasretainedbytheCommitteeatitspresentmeeting,andtheADIfornitritewassetat0
0.07mg/kgbw,expressedasnitriteion(Annex1,reference116).Allvaluesfornitrateandnitriteintheintakeassessmentsareexpressedastheionstoallowdirect
comparisonwiththerespectiveADIs.
DataonnitrateandnitriteforreviewbytheCommittee,includingnationalintakeassessments,weresubmittedbyAustralia,theNetherlands,NewZealandandtheUnited
Kingdom(Table1).BothAustraliaandNewZealandsubmittedestimateddietaryintakesofnitrateandnitritebasedonindividualdietaryrecords.TheNetherlands
submitteddatafrommonitoringandtheresultsofaduplicatedietstudy(Vaessen&Schothorst,1999).TheUnitedKingdomsubmittedtheresultsofmonitoringthatalso
includedintakeassessments,asurveyofnitrateandnitriteinbaconandcuredmeats(MinistryofAgriculture,FisheriesandFood,1998a),reportsoftwototaldietstudies
(MinistryofAgriculture,FisheriesandFood,1997a,1998b),theresultsofaduplicatedietstudyofnitrateintakebyvegetarians(MinistryofAgriculture,Fisheriesand
Food,1998b)andastudyofthemetabolismofdietarynitrate(McKnightetal.,undated).
Table1.Summaryofsubmissionsonintakeofnitrate
Country
'Poundage'
data
Foodbalancesheets,
householdeconomic
surveys,salesdata
Model
diets
Individual
dietaryrecords
Monitoring
Australia
Netherlands
NewZealand
UnitedKingdom
1.1Concentrationsinfoods
AregulationoftheEuropeanCommission(194/97)requiresMemberStatestomonitortheconcentrationsofnitrateinlettuceandspinachtoensurethattheyremain
acceptable.TheNetherlandssubmittedtheresultsofmonitoringofnitrateconcentrationsinlettuceandspinach(vanderSchee,1997vanderSchee&Speek,2000a,b),a
surveyofnitrateinothervegetables(vanderSchee,1998)andtheresultsofmonitoringforadherencetogoodagriculturalpracticeinspinachandlettuce(deKreij,1998
deKreij&vanWinkel,2000deKreij,2001).Thenitrateconcentrationsinlettucecollectedoverallseasonsforanumberofyearsrangedbetween40and5500mg/kg,
whilethoseinspinachwerebetween30and6000mg/kg.Themeanconcentrationsinothervegetableswere1900mg/kg(maximum,3400mg/kg)inendiveand1800
mg/kg(maximum,4700mg/kg)inbeetroot.
TheUnitedKingdomsubmittedtheresultsofnumerousmonitoringsurveysfornitrateinlettuceandspinach(MinistryofAgriculture,FisheriesandFood,1997b,1998c,
1999,2001)andinothervegetables(MinistryofAgriculture,FisheriesandFood,1996,1998d).Thenitrateconcentrationsinlettucecollectedoverallseasonsfora
numberofyearsrangedbetween50and5300mg/kg,whilethoseinspinachwerebetween25and4600mg/kg.Theconcentrationsinothervegetableswere<3mg/kg
(belowthelimitofdetection)forleeksand4200mg/kgforradishes.Themeanresidueofnitrateinallcuredmeatproductswas180mg/kg.Themeanresidueofnitrite
was120mg/kginbaconand65mg/kginothercuredmeats(MinistryofAgriculture,FisheriesandFood,1998a).
Nitrateandnitriteoccurnaturallyinwater,butfarmingandeffluentscanincreasethelevelsofthesechemicalsinsomewaters.Nitriteisrapidlyoxidizedtonitratein
waterandisrarelyfoundinwelloxygenatedorchlorinatedwater(CooperativeResearchCentre,1996).TheWHOguidelinefornitrateindrinkingwateris50mg/l,and
theprovisionalguidelinefornitriteis0.2mg/l(WHO,1998b).TheguidelinelevelsindrinkingwaterinAustraliaandNewZealandare50mg/lfornitrateand3mg/lfor
nitrite(NationalHealthandMedicalResearchCouncilandAgricultureandResourceManagementCouncilofAustraliaandNewZealand,1996MinistryofHealth,
2000).
Theconcentrationofnitrateinsurfacewaterisusuallylow,between0and18mg/l,whilethenaturalconcentrationingroundwaterisonlyafewmilligransperlitre.The
concentrationindrinkingwaterinmostcountriesis<10mg/l(WHO,1998a),althoughalevelof1500mg/lwasreportedfornitrateinIndia.Thenitrateconcentrationin
waterinAustraliaisusually<0.15mg/Lbutcanrangeupto18mg/lThenitriteconcentrationinwaterintheUSAdoesnotexceed0.3mg/l,andthatindrinkingwaterin
theNetherlandsisusually<0.1mg/l(CooperativeResearchCentre,1996).
2.ASSESSMENTSOFINTAKE
2.1Intakefromsourcesotherthanfoodadditives
TheintakesofnitrateandnitritefromfoodwerecalculatedatagloballevelonthebasisofmeanfoodconsumptionintheGEMS/Foodregionaldiets(WHO,1998c),and
themeanconcentrationsinfoodsinEuropefromthesubmitteddata.Intakefromdrinkingwaterwasadded,assumingawaterconsumptionof2l/dayinalldietsexcept
theEuropeandiet,inwhichitwasconsideredtobe1l/day.Themeanconcentrationinwaterthatwasusedintheintakecalculationswas4mg/lfornitrateand0.3mg/l
fornitrite,whicharerepresentativeoftheusualconcentrationsfoundinwater(WHO,1998a).Anaveragebodyweightof60kgwasusedfortheglobalintake
assessments.Thecalculationsofintake(fromconsumptionfiguresandmeanconcentrations)areshowninTable2,andtheconcentrationsandsourcesaresummarizedin
Table3.TheestimatedintakesaresummarizedinTable4.
Table2.Calculationofnitrateandnitriteintakesfromsourcesotherthanfoodadditivesatthegloballevel
Food
analysed
Codex
code
Concentration
(mg/kg)
Diet
MiddleEastern
FarEastern
African
LatinAmerican
European
Consumption
(g/d)
Intake
(mg/d)
%
total
intake
Consumption
(g/d)
Intake
(mg/d)
%
total
intake
Consumption
(g/d)
Intake
(mg/d)
%
total
intake
Consumption
(g/d)
Intake
(mg/d)
%
total
intake
Consumption
(g/d)
Nitrate
Lettuce
VL482
1700
2.3
4.0
10
5.8
10
19
22
Spinach
VL502
1900
0.5
0.93
0.3
0.56
Endive
VL476
1900
0.5
0.97
0.3
0.58
Beetroot
VR574
1500
0.5
0.74
0.3
0.45
Apple
FP226
30
7.5
0.22
4.7
0.14
0.3
0.009
5.5
0.16
40
Asparagus
VS621
30
1.5
Aubergine
VO440
440
6.3
2.8
1.3
0.7
0.31
2.6
2.3
Broccoli
VB400
440
0.5
0.22
0.44
1.1
0.49
2.7
Brussels
sprouts
VB402
35
0.5
0.018
0.035
1.1
0.038
2.7
Carrot
VR577
220
2.8
0.62
2.5
0.55
6.3
1.4
22
Celery
VS624
2900
0.5
1.5
0.3
0.88
Chinese
cabbage
VL466
3500
0.1
0.35
0.1
0.35
0.1
0.35
0.1
0.35
0.1
Garlic
VA381
35
0.07
2.2
0.077
0.5
0.018
Grape
FB269
70
16
1.1
0.07
1.3
0.091
14
Kohlrabi
VB405
2700
0.1
0.27
0.1
0.27
0.1
0.27
0.1
0.27
0.1
Onion
VA385
110
23
2.5
12
1.3
7.3
0.80
14
1.5
28
Pear
FP230
20
3.3
0.066
2.8
0.056
0.02
11
Potato
VR589
180
5.9
1.1
19
3.4
13
21
3.7
18
41
7.3
14
240
Radish
VR494
2100
0.5
1.0
0.3
0.63
Rhubarb
VS627
1600
0.5
0.8
0.3
0.50
Shallot
VA388
65
0.13
1.5
0.10
0.26
Sweet
pepper
VO445
120
3.3
0.40
0.23
5.3
0.61
2.3
0.26
10
Turnip
VR506
4800
0.5
2.4
0.3
1.4
Cauliflower
VB404
85
1.3
0.11
1.5
0.13
0.3
0.026
13
Cabbage
VB41
340
1.7
9.7
3.3
12
10
3.6
27
Swede
VR497
120
0.5
0.06
0.3
0.036
Tomato
VO448
15
82
1.2
0.10
16
0.25
26
0.38
66
Cereals
GC80,
total
10
430
4.3
11
450
4.5
17
320
3.2
15
250
2.5
230
Fishonly
Fresh,
frozen
3.3
0.016
8.3
0.042
0.04
3.1
0.016
Fats&oils
Total
animal&
vegetable
41
0.21
16
0.080
24
0.12
27
0.14
49
Eggs
PE840
14
0.072
13
0.065
3.6
0.018
12
0.059
38
Fruit
Total
fruit,
minus
appleand
pear
25
19
0.48
78
1.9
94
2.4
11
260
6.6
12
160
Sugars
Total,not
including
honey
10
95
0.95
50
0.50
42
0.42
100
1.0
110
Milk
ML106,
all
120
0.58
32
0.16
42
0.21
160
0.8
290
Dairy
Cream
20
8.5
0.17
4.5
0.09
33
Nuts
TN85
10
0.01
14
0.14
3.4
0.034
18
0.18
3.8
Water
2000
20
2000
29
2000
38
2000
15
1000
Total(mg/d)
40
27
21
53
%ADI
20
10
10
25
Nitrite
Potato
VR589
0.7
5.9
0.0041
19
0.013
21
0.014
41
0.028
240
Vegetables
Total
0.6
230
0.14
180
0.11
77
0.046
150
0.090
370
Cereals
GC80,
total
2.6
430
1.1
54
450
1.2
59
320
0.83
52
250
0.66
40
230
Fish
Fresh,
frozen
only
0.5
3.3
0.0016
8.3
0.0042
0.004
3.1
0.0016
Fats&oils
Total
animal&
vegetable
0.5
41
0.021
16
0.0080
24
0.012
27
0.014
49
Eggs
PE840
2.6
14
0.038
13
0.034
3.6
0.0094
12
0.031
38
Eggs
PE840
2.6
14
0.038
13
0.034
3.6
0.0094
12
0.031
38
Fruit
Totalfruit
0.5
200
0.10
85
0.043
95
0.047
270
0.14
210
Milk
ML106,
all
0.5
120
0.058
32
0.016
42
0.021
160
0.08
290
Dairy
Cream
0.5
4.8
Nuts
TN85
0.5
0.0005
14
0.0068
3.4
0.0017
18
0.0088
3.8
Water
0.3
2000
0.6
29
2000
0.6
30
2000
0.6
38
2000
0.6
36
1000
Total(mg/d)
2.1
2.0
1.6
1.7
1.7
%ADI
50
50
40
40
40
Table3.Concentrationsofnitrateandnitrite(mg/kg)usedtocalculatemeanconcentrationsforuseinglobalintakecalculations
Food
Sourceofdata
vander
Schee&
Speek
(2000a)
van
der
Schee
&
Speek
(1999)
vander
Schee
(1996)
vander
Schee
(1998)
MAFF
(1996)
MAFF
(1998d)
MAFF
(1998c)
MAFF
(1997b)
MAFF
(1999)
MAFF
(2001)
MAFF
(1997a)
MAFF
(1998b)
Meanused
in
calculations
(mg/kg)
Nitrate
Lettuce
2200
2100
2000
2100
1600
1000
1400
1700
1500
1500
1700
Spinach
1800
1700
2500
2800
1700
1600
1300
1400
2000
1700
1900
Endive
2000
1900
1900
Beetroot
1800
1200
1500
Apple
29
30
Asparagus
31
30
Eggplant
440
440
Broccili
440
440
Brussels
sprouts
11
59
35
Carrot
340
97
220
Celery
2900
2900
Chinese
cabbage
3600
3500
Garlic
35
35
Grape
72
70
Kholrabi
2700
2700
Onion
170
48
110
Pear
20
20
Potato
280
180
160
180
Radish
2100
2100
Rhubarb
1700
1600
Shallot
64
65
Sweet
pepper
120
120
Turnip
4800
4800
Cauliflower
86
85
Cabbage
340
340
Swede
120
120
Tomato
17
15
Cereals
9.2
11
10
Fish
8.6
11
Fats&oils
8.1
7.6
Eggs
8.1
5.4
Fruit
26
27
25
Sugars
8.0
8.7
10
Milk
8.8
8.3
Dairy
9.4
27
20
Nuts
9.5
6.1
10
Nitrite
Potato
0.8
0.5
0.7
Vegetables
0.6
0.6
0.6
Cereals
3.3
1.8
2.6
Fish
0.6
0.4
0.5
Fats&oils
0.6
0.4
0.5
Eggs
3.4
1.7
2.6
Fruit
0.6
0.4
0.5
Milk
0.6
0.4
0.5
Dairy
0.6
0.4
0.5
Nuts
0.6
0.4
0.5
Table4.Estimatedintakesofnitrateandnitritefromsourcesotherthanfoodadditivesatthegloballevel
Chemical
Regionaldiet
Intake
(mg/day)
%ADIa
Majorcontributorsto
totalintake(%)
Nitrate
MiddleEastern
40
20
Vegetablesother
thanpotato(60)
Water(20)
Cereals(10)
Fruit(5)
FarEastwerm
28
10
Vegetables(45)
Water(30)
Cereals(15)
Fruit(10)
African
20
10
Water(40)
Vegetables(30)
Cereals(15)
Fruit(10)
LatinAmerican
55
25
Vegetables(65)
Water(15)
Fruit(10)
Cereals(50)
European
155
70
Vegetables(90)
Water(5)
Fruit(5)
Cereals(<5)
Nitrite
MiddleEastern
2.1
50
Cereal(55)
Water(30)
FarEastern
2.0
50
Cereal(60)
Water(30)
African
1.6
40
Cereal(50)
Water(40)
LatinAmerican
1.6
40
Cereal(40)
Water(35)
European
1.7
40
Cereal(35)
Water(20)
aBasedon60kgbodyweight
2.2Intakefromuseasafoodadditive
2.2.1Screeningbythebudgetmethod
Thebudgetmethodisusedtoestimatethetheoreticalmaximumlevelofafoodadditiveintheproportionofthefoodand/orbeveragesupplylikelytocontainitthat
wouldnotresultinexceedanceoftheADIbythepopulation(Hansen,1979).Thefactorstakenintoconsiderationarephysiologicalenergyrequirementsandtheenergy
densityoffood.Thebudgetmethodisusedtoassesswhetheruseoftheadditiveshouldberestrictedandwhetheranintakeassessmentisrequired.
Itisnotentirelyappropriatetousethebudgetmethodfornitrateandnitrite,becausenotalltheintakeofthesechemicals,andthereforethecontributiontotheADI,is
derivedfromuseasfoodadditives,asisgenerallythecasewhenthebudgetmethodisused.However,astheproportionoftheADIcontributedbysourcesotherthan
additivesisnotknown,thefullADIwasusedforthebudgetmethodcalculations.
Thebudgetmethodwasusedtocalculatenitrateinfoodandbeverages,astheGSFAhasdeterminedmaximumpermittedlevelsforboth.Astheproportionofuseinsolid
foodsandinbeveragesisunknown,itwasassumedtobe50%foreach.Itwasalsoassumedthat50%ofthefoodsupplyand25%ofbeveragescontaintheadditive.The
theoreticalmaximumlevelof150mg/kgforsolidfood(seeTable5)isbelowthemaximumpermittedleveloftheGSFA(360mg/kg),andthetheoreticalmaximumlevel
of72mg/kgforbeveragesissimilartothemaximumpermittedleveloftheGSFA(73mg/kg).Anintakeassessmentisthereforerequired,andrestricteduseofthefood
additiveshouldbeconsidered.
Table5.Estimatedtheoreticalmaximumlevelsofnitrateandnitritebythebudgetmethod
Additive
Distributionin
foodsupply
%solidfood
orbeverage
supply
Theoretical
maximum
level
(mg/kg)
GSFA
maximum
permittedlevel
(mg/kg)a
National
maximum
permittedlevel
(mg/kg)b
Nitrate
50%food
50
150
360
360
50%beverages
25
72
73
73
Nitrite
100%food
50
5.6
420
83
aHighestlevelinfoodandbeveragesaccordingtotheGSFA
bHighestlevelsinfoodandbeveragesinnationalsubmissions
Thebudgetmethodwasusedtocalculatenitriteonlyinfood,astheGSFAprovidesamaximumpermittedlevelonlyforsolidfoods.Itwasassumedthat50%ofthesolid
foodsupplycontainstheadditive.Thetheoreticalmaximumlevelforsolidfoodof5.6mg/kg(seeTable5)iswellbelowthemaximumpermittedlevelintheGSFAof
420mg/kg.Anintakeassessmentisthereforerequired,andrestricteduseoftheadditiveshouldbeconsidered.
ComparisonofthetheoreticalmaximumlevelswiththenationalmaximumpermittedlevelsresultedinconclusionssimilartothosebasedontheGSFA.
2.2.2Assessmentsbasedonindividualdietaryrecords
IntakesofnitrateandnitriteasfoodadditivesestimatedfromindividualdietaryrecordsweresubmittedbyAustraliaandNewZealand(Table6).Intheseassessments,
intakewascalculatedforeachindividualonthebasisofbodyweight,beforepopulationstatisticswerederived.Theintakeassessmentsofbothcountriesincluded
estimatesofintakebasedonthemaximumpermittedlevelofeachadditiveinfoodsineachcountryandonthoseoftheGSFA.TheAustralianassessmentsalsoincluded
dietaryintakeestimatesbasedonlevelsofuseofnitriteinindustry.ThenationalandGSFAmaximumpermittedlevelsandthedataonfoodconsumptionaggregated
fromdataonindividualfoodconsumptionusedintheintakeassessmentsareshowninTables7and8,respectively.
Table6.Summaryofestimatesofintakeofnitrateandnitriteasfoodadditivesbasedonindividualdietaryrecords
Country
Date
Survey
Assumptions
Additive
Populationbwper
Intake
Australia
(Aus)
1995
Nationalnutrition
survey24h
recall2years
sample,13858
day)
Nitrate
Meanconsumers
Aus
0.34
10
Nominatedmanufacturesuse
level
GSFA
0.45
10
ModifiedGSFAclassification
system
Meanconsumers
Adjustedforindividualbody
weight
95th%ile
consumersAus
1.3
35
95th%ile
consumersGSFA
1.3
35
Meanconsumers
AusMaximum
permittedlevel
0.09
130
Meanconsumers
Ausnominated
manufacturesuse
level
0.07
100
Meanconsumers
GSFA
0.35
500
95th%ile
consumersAus
maximum
permittedlevel
0.29
420
95th
%ileconsumers
Ausnominated
manufacturersuse
level
0.22
320
95th%ile
consumersGSFA
0.97
1400
Meanconsumers
NZmaximum
permittedlevel
0.33
10
Adjustedforindividualbody
weight
Meanconsumers
GSFA
0.41
10
Doesnotincludenon
processedfoodorwater
95th%ile
consumersNZ
1.2
35
95th%ile
consumersGSFA
1.1
30
Meanconsumers
NZmaximum
permittedlevel
0.09
130
Meanconsumers
GSFA
0.32
460
95th%ile
consumersNZ
0.25
360
95th%ile
consumersGSFA
0.90
1300
Maximumpermittedlevel(Aus
orGSFA)
Doesnotincludenon
processedfoodorwater
New
Zealand
(NZ)
1997
Nationalnutrition
survey24h
recall>15years
ample,4636
%ADIa
(mg/kg)
group
Maximumpermittedlevel(Aus
orGSFA)
Nitrite
Nitrate
ModifiedGSFAclassification
system
Nitrite
aADI,03.7mg/kgbwfornitrateand00.07mg/kgbwfornitrite
Table7.NationalanddraftGSFAmaximumpermittedlevelsofuseusedintheintakeassessmentsforAustraliaandNewZealand
Additive
Codea
Foodcategorydescription
Maximumpermittedlevelin
AustraliaandNewZealand
(industryuse)(mg/kg)
GSFAmaximum
permittedlevel
(mg/kg)
Nitrate
1.6
Cheeseandcheeseproducts
45
37
8.1
Rawmeat,poultryandgame
150
8.2
Processedmeat,poultryandgame
products,whole
449
3650
8.3
Processedcomminutedmeat,
449
360
poultryandgameproducts
Nitrite
8.4
Ediblecasings
140
9.3
Semipreservedfishandfish
products
220
14.2.5
Spiritsandliqueurs
73
1.6
Cheeseandcheeseproducts
17
8.2
Processedmeat,poultryandgame
products,wholepiecesandcuts
83
420
8.3
Processedcomminutedmeat,
poultryandgameproducts
83
130
8.3.2
Sausageandsausagemeat
83
(0)
9.2.2
Roe
9.3
Semipreservedfishandfish
products
130
aAustraliaNewZealandFoodClassificationSystem
Table8.AggregatedfoodconsumptionfromindividualdatausedinintakeassessmentswithAustralian,NewZealandandGSFAmaximumpermittedlevels
Foodgroup
Consumers
No.
%ofall
respondentsa
Australia
Cheeseandcheese
products
7000
Rawmeat,poultryand
game
All
respondents
Consumersonly(meang/day)
Mean
Median
95th%ile
50
18
36
24
99
9600
69
97
140
110
370
Processedmeat,poultry
andgameproducts,whole
cut
4000
29
12
42
29
120
Processedcomminuted
meat,poultryandgame
3100
23
17
76
56
220
Ediblecasings
Semipreservedfishand
fishproducts
84
0.6
0.6
100
62
380
Cannedroe
13
0.1
0.0
36
19
120
Spiritsandliqueurs
660
4.7
3.7
78
48
270
NewZealand
Cheeseandcheese
products
2200
46
17
36
26
110
Rawmeat,poultryand
game
3300
71
98
140
110
350
Processedmeat,poultry
andgameproducts,whole
cut
1200
27
14
51
31
160
Processedcomminuted
meat,poultryandgame
1200
26
21
78
56
220
Ediblecasings
Semipreservedfishand
fishproducts
28
0.6
0.5
81
63
290
Roe
0.1
0.1
71
42
160
Spiritsandliqueurs
320
7.0
5.0
71
44
240
aAllrespondents:13858inAustraliaand4636inNewZealand
2.3Intakefromallsources
2.3.1Assessmentsbasedontotaldietstudies
Modeldietsareconstructedfrominformationonfoodconsumption.Theyaredesignedtorepresentthetypicaldietofageneralpopulationoraspecifiedpopulation
subgroupandincludefoodscontainingthefoodadditive.
TheintakesestimatedfromthetotaldietstudiessubmittedbytheUnitedKingdomarepresentedinTable9.Theresultsarepresentedforthewholepopulationthelower
boundestimatesareforanalyticalconcentrationsbelowthelimitofdetection,assumedtobezero,andtheupperboundestimatesareforanalyticalconcentrationsatthe
limitofdetection.Theresultsforadultconsumersincludeestimatedintakeofnitratefromwaterandbeerandofnitritefromwateronly,inordertoestimatethetotal
dietintake.Theassessmentsarebasedonmeasuredconcentrationsinfoods.TheintakesinthesubmittedreportswerecomparedwiththeADIsoftheScientific
CommissionforFoodof3.6mg/kgbwfornitrateand0.06mg/kgbwfornitrite.Forthepresentassessment,theestimatedintakeswerecomparedwiththeADIs
establishedbytheCommittee.
ThenitrateandnitriteconcentrationsfoundinthetotaldietstudiesareshowninTable10.Table11showsconsumptiondataforeachfoodgroupusedtoestimate
populationintake.Dataonfoodconsumptionbyconsumersonlywerenotprovided.
Table9.Estimatesofintakeofnitrateandnitritefromtotaldietstudies
Country
Date
Survey
Assumptions
Additive
group
Populationbwperday)
Intake
(mg/kg)
%ADIa
United
Kingdom
1997
Totaldiet
study:diets
basedon
averageof3
previousyears
ofdatafrom
NationalFood
Survey.
Proportionof
foodindiets
represents
foods
importancein
diet.Samples
<LOD=LOD
(4mg/kg
nitrate,0.4
mg/kgnitrite)
Analysedconcentrations
incompositesamples
Nitrate
Meanadultconsumers:
foodonly
0.95
25
Populationestimates
includeadultsand
children
97.5%ileadult
consumers:foodonly
1.8
50
Beerandwatercontribute
significantlytonitrate
intakes
Meanadultconsumers:
food,water,beer
1.5
40
Averagebodyweight=
60kg
97.5%ileadult
consumer:food,water,
beer
2.3
60
Wholepopulation:
lowerbound
0.82
20
Wholepopulation
upperboundfoodonly
0.86
25
Meanadultconsumers:
foodonly
0.022
30
97.5%ileadult
consumers:foodonly
0.037
55
Meanadultconsumers:
food,water,beer
0.023
35
97.5%ileadult
consumer:food,water,
beer
0.038
55
Wholepopulation:
lowerbound
0.012
15
Wholepopulation
upperbound
0.021
30
Meanadultconsumers:
foodonly
1.1
30
Populationestimates
includeadultsand
children.
97.5%ileadult
consumers:foodonly
2.3
60
Beerandwatercontribute
significantlytonitrate
intakes
Meanadultconsumers:
food,water,beer
1.7
45
Samples<LOD=LOD(8
mg/kgnitrate,0.6mg/kg
nitrite)
97.5%ileadult
consumer:
2.8
75
food,water,beer
Wholepopulation:
lowerbound
0.93
25
Wholepopulation
upperbound
1.1
30
Meanadultconsumers:
foodonly
0.028
40
Nitrite
United
Kingdom
1994
Totaldiet
study:diets
basedon
averageof3
previousyears
ofdatafrom
NationalFood
Survey.
Proportionof
foodindiets
represents
foods
importanceof
foodindiet
Analysedconcentrations
incompositesamples
Nitrate
Averagebodyweight=
60kg
Nitrite
97.5%ileadult
consumers:foodonly
0.048
70
Meanadultconsumers:
food,water
0.03
45
97.5%ileadult
consumer:food,water
0.05
70
Wholepopulation:
lowerbound
0.01
15
Wholepopulation
upperbound
0.028
40
aADI,03.7mg/kgbwfornitrate,00.07mg/kgbwfornitrite
Table10.NitrateandnitriteconcentrationsusedintotaldietstudiesintheUnitedKingdomin1994and1997
Foodgroup
Meannitrateconcentration(mg/kg)
Meannitriteconcentrations(mg/kg)
1994
1994
1997
1997
Lower
bound
Upper
bound
Lower
bound
Upper
bound
Lower
bound
Upper
bound
Lower
bound
Upper
bound
Bread
10
13
7.2
0.1
0.6
ND
0.4
Miscellaneous
cereals
3.2
9.2
10
11
3.3
3.3
1.8
1.8
Carcassmeats
0.5
8.1
4.1
5.1
ND
0.6
ND
0.4
Offal
1.8
8.6
3.9
5.3
1.1
1.3
0.9
0.9
Meatproducts
49
49
45
45
2.1
2.1
4.1
4.1
Poultry
88
91
8.1
8.5
0.4
0.8
0.4
0.5
Fish
3.4
8.6
11
11
ND
0.6
ND
0.4
Oilsandfats
0.5
8.1
7.2
7.6
ND
0.6
ND
0.4
Eggs
0.9
8.1
4.4
5.4
2.9
3.4
1.7
1.7
Sugarsand
preserves
ND
8.0
8.3
8.7
ND
0.6
ND
ND
Greenvegetables
440
440
320
320
0.3
0.7
ND
0.5
Potatoes
140
140
140
140
0.4
0.8
ND
0.5
Othervegetables
180
180
100
100
0.1
0.6
0.4
0.6
Cannedvegetables
17
17
18
18
0.5
0.8
ND
0.5
Freshfruit
25
26
27
27
ND
0.6
ND
0.4
Fruitproducts
11
15
12
13
0.2
0.7
ND
0.4
Beverages(not
furtherspecified)
ND
2.5
4.7
ND
0.6
ND
0.5
Milk
1.6
8.8
3.9
5.3
ND
0.6
ND
0.4
Dairyproduce
3.4
9.4
27
27
ND
0.6
ND
0.4
Nuts
3.1
9.5
5.5
6.1
ND
0.6
ND
0.5
ND,notdetectedlimitofdetection,4mg/kgnitrate,0.4mg/kgnitritein19978mg/kgnitrate,0.6mg/kgnitritein1994
Table11.Foodconsumptionfiguresfromthe1994and1997totaldietstudiesintheUnitedKingdomusedforestimatingtheintakeofthewholepopulation
Foodgroup
Consumption(g/day)
1994
1997
Bread
0.110
0.108
Miscellaneouscereals
0.100
0.101
Carcasemeats
0.026
0.022
Offal
0.001
0.001
Meatproducts
0.044
0.047
Poultry
0.018
0.019
Fish
0.013
0.014
Oilsandfats
0.029
0.027
Eggs
0.016
0.014
Sugarsandpreserves
0.067
0.063
Greenvegetables
0.037
0.034
Potatoes
0.133
0.123
Othervegetables
0.073
0.076
Cannedvegetables
0.035
0.033
Freshfruit
0.065
0.069
Fruitproducts
0.043
0.044
Beverages
0.863
0.937
Milk
0.284
0.281
Dairyproduce
0.057
0.060
Nuts
0.002
0.002
2.3.2Assessmentsbasedonduplicatedietstudies
TheUnitedKingdomsubmittedastudywithduplicatedietsinvolving35vegetarians,whichwasintendedtodeterminewhetherthenitrateintakeofthispopulationgroup
washigherthanthatofthegeneralpopulationowingtotheirgreaterconsumptionofvegetables.Respondentscollectedduplicatesamplesofallfoodsandsomebeverages
(soyamilk,soyamilkincoffeeortea,herbaldrinksandsoup)thattheyhadconsumedover7days.Datawerecollectedtwiceayeartoaccountforseasonalvariationin
nitrateconcentrationsinvegetables.Foodswereweighedandanalysed,andtheestimatednitrateintakeswerecalculated(Table12).Asthefoodswereweighedand
analysedtogether,themeasuredconcentrationsineachfoodwerenotavailable.
Table12.Summaryofestimatesofintakeofnitrateandnitritebasedonduplicatedietstudies
Country
Date
Survey
Assumptions
Additive
Populationgroup
Intake
(mg/kg)
bwper
day)
%ADIa
United
Kingdom
1998
Duplicatediet
ofvegetarians
7days
35respondents
Adultsonly
Nitrate
Mean,foodonly
0.87
25
Maximum,food
only
2.9
80
Mean,food,water,
beer
1.4
35
Maximum,food,
water,beer
3.5
95
Mean
1.1
30
Maximum
4.4
120
Median
<0.003
<5
Maximum
0.23
330
Netherlands
1994
Duplicatediet
ofadults
1day
123
respondents
Age,1874
years
Individualbodyweights
usedLOQ,2mg/kgfor
nitrate,0.4mg/kgfor
nitrite
Nitrate
Nitrite
LOQ,limitofquantification
aADI,03.7mg/kgbwfornitrateand00.06mg/kgbwfornitrite
A24hduplicatedietstudywasconductedintheNetherlandsin1994toestimatethenitrateandnitriteintakeinfoodanddrinkingwaterof123adultsaged1874and
livinginvarioustowns.Datawerecollectedtwiceduringtheyeartoaccountforseasonalvariationinchemicalconcentrations.Thefoodswereweighedandanalysed,
andtheintakeswerecalculated(Table12).Themeanfoodintakewas2600g/day(2500gforwomenand2800gformen),andthemeanbodyweightwas75kg(71kg
forwomenand79kgformen).Asthefoodswereanalysedashomogenizedsamples,theconcentrationsinindividualfoodswerenotavailable(Vaessen&Schothorst,
1999).
2.4Intakereportedintheliterature
Manyassessmentsofnitrateandnitriteintakeshavebeenreportedintheliterature,butmostdidnotprovidedetailsofhowtheywereconductedandarethereforedifficult
tointerpretorcompare.
AnassessmentofintakeoffoodadditivesinIrelandwasconductedinresponsetoaDirectiveoftheEuropeanCommission(Directive1989/107,AnnexII,point4),
whichrequiresMemberStatestomonitorthelevelsofadditivesinfoods.Theintakeofnitritewasestimatedtobe0.20mg/kgbw,or290%oftheADI.Thisestimatewas
basedon1000individualrecordsfroma7daydietarysurvey(agegroupnotspecified)andmaximumpermittedlevelsoftheadditiveinIreland.Nononprocessedfoods
orwaterwereincludedinthereport.Itwasconcludedthatafurther,moredetailedassessmentofnitritewasrequired(FoodSafetyAuthorityofIreland,2001).
TheintakeofnitrateasafoodadditiveinFinlandwasreportedtorepresent31%oftheADI(Branenetal.,1990).AnotherFinnishstudyreportedameanintakeof
77mg/dayfornitrate(35%oftheADIfora60kgperson)and5.3mg/dayfornitrite(150%oftheADIfora60kgperson).Thissurveyincludedvegetables,fruits,
cheese,meatandfish.Morethan90%ofthedietarynitratewasfromvegetables,andnitritewasderivedmainlyfrommeatproducts(95%).Theconcentrationsofthe
foodadditivesinfoodswereobtainedfromvariousEuropeanstudies,andthedietarydatawerebasedon1yearquantitativediethistoriesfromapproximately10000
peopleover15yearsofage.Astheintakeassessmentdidnotincludedrinkingwater,thereportedestimatedintakesarelowerthanwouldotherwisebecalculated(Dichet
al.,1996).
TheintakeofnitrateasafoodadditiveinJapanwasreportedtorepresent120%oftheADI.ThenitriteintakeinatotaldietsurveyinJapanin1982was0.0018
mg/person,whichwouldbebelowtheADI,assuming55kgbodyweight(Branenetal.,1990).
TheMinistryofAgriculture,FisheriesandFood(1998a)intheUnitedKingdomreportedthatthenitrateandnitriteintakesbyconsumersofcuredmeatproductsatahigh
percentilewere19%and1%oftherespectiveADIs(agegroupnotspecified).Thissurveydidnotincludeotherfoodsorbeverages.Numeroussurveillancestudiesofthe
MinistryofAgriculture,FisheriesandFood(1997b,1998c,1999,2001)ofspinachandlettuceincludedestimatesofintakeofnitratetheseresultsaresummarizedin
Table13.Theresultsweresimilarinallthesurveys.Anotherstudy(MinistryofAgriculture,FisheriesandFood,1997b)indicatedthattheintakebyconsumersoflettuce
orspinach(nootherfoods)atameanorhighpercentilewouldnotexceedtheADI.AstheADIof3.7mg/kgbwfornitrateisequaltoanintakeof220mg/dayfora60kg
person,noneoftheestimatedintakesinthesestudieswouldexceedtheADI,evenforconsumersathighpercentiles.
Table13.SummaryofstudiesofintakeofnitratebytheMinistryofAgriculture,FisheriesandFoodintheUnitedKingdom
Foodsincluded
Consumerintake(mg/day)
Yearof
reference
Mean
97.5%ile
Lettuceorspinachandbeerandwater
88
140
2001
Spinachorlettuce,withadditionalvalueaddedfor
restofdiettakenfromestimatesinthe1997totaldiet
studyintheUnitedKingdom
78
140
1999
Varioustypesoflettuceorspinachandbeerandwater
110
210
1998
AstudyontheeffectsofcookingonnitrateconcentrationsinvegetableswasalsocarriedoutbytheMinistryofAgriculture,FisheriesandFood(1998d).Cookingby
boilingreducedthenitrateconcentrationinmostvegetablestestedbyupto75%.
3.EVALUATIONOFESTIMATESOFINTAKE
3.1Intakefromsourcesotherthanfoodadditives
TheestimatedintakesofnitrateandnitritefromsourcesotherthanfoodadditivesarebelowtheirrespectiveADIs.TheintakesofnitratefromthevariousGEMS/Food
regionaldietsrepresented20%oftheADIfortheMiddleEasterndiet,10%oftheADIfortheFarEasterndiet,10%oftheADIfortheAfricandiet,25%oftheADIfor
theLatinAmericandietand70%oftheADIfortheEuropeandiet.Thenitriteintakesrepresented50%oftheADIfortheMiddleEasternandFarEasterndietsand40%
oftheADIfortheAfrican,LatinAmericanandEuropeandiets.Vegetableswerethemaincontributortonitrateintake,accountingfor3090%ofthatestimated.Potatoes
wereincludedamongvegetables,andinsomedietstheseweremajorcontributors,representing15%oftheestimatedintakeintheFarEasterndiet,29%intheAfrican
diet,15%intheLatinAmericandietand30%intheEuropeandiet.Cerealswerethemaincontributortonitriteintake,accountingfor3560%oftheestimatedintake.
Drinkingwaterwasthesecondhighestcontributortotheestimatedintakesofbothchemicals,at540%oftheestimatedintakeofnitrateand2040%ofthatofnitrite.
Theseestimatesarebasedonmeanchemicalconcentrationsandmeanfoodconsumptionatthegloballevelandprovideareasonableguidetoestimatesofintakeandthe
contributionsofvariousfoodgroups.
3.2Intakefromuseasafoodadditive
ScreeningfornitrateandnitritebythebudgetmethodindicatedthatthetheoreticalmaximumlevelswerebelowsomeofthemaximumpermittedlevelsintheGSFA.
Thisindicatedtheneedforintakeassessmentsandsuggestedthatuseofnitrateandnitriteasfoodadditivesmighthavetoberestricted.
TheestimatedintakesbasedonindividualdietaryrecordsinAustraliaandNewZealandwerecomparedwithmaximumpermittedlevelsfromnationalfoodstandardsand
fromtheGSFA.Theresultsindicatedthat,fornitrate,theADIwasnotexceededforconsumersatthemean(10%oftheADI)oratahighpercentile(35%oftheADI).
Theseestimateswerebasedon24hdataonfoodconsumption,whichtendtooverestimatetheadditiveintakeofconsumersathighpercentiles.Evenafterwaterwas
includedinthenationalassessments(50mgofnitratebasedonconsumptionof1lofwaterperdayandthemaximumguidelinelevelinwater),thenitrateintakewasstill
belowtheADI.
TheAustralianandNewZealandassessmentsofintakeofnitrate,however,didnotincludeacontributionfromsourcesotherthanadditives.Itisknownthatfoodssuchas
vegetablescontributesubstantiallytonitrateintake,butitwasdifficulttoestimatetheimpactofnonadditivesourcesontheaboveestimates.
TheintakesofnitriteestimatedfromindividualdietaryrecordsinAustraliaandNewZealandindicatedthattheADImightbeexceededbyconsumersatboththemean
andhighpercentiles,onthebasisofeithernationalmaximumpermittedlevelsofnitriteormaximumpermittedlevelsintheGSFA.Theintakesofconsumersatthemean
innationalestimateswere100130%oftheADI,andthosebasedontheGSFAwere460500%oftheADI.Theintakesbyconsumersatthe95thpercentileinnational
estimateswere320360%oftheADI,andthosebasedontheGSFAwere13001400%oftheADI.However,theseintakesarelikelytobeoverestimates,astheyare
basedonthemaximumlevelsthatcanbeaddedbymanufacturers,ratherthanactuallevelsinfoodsasconsumed,andonthebasisoftheassumptionthatallfoodsinthe
groupcontaintheadditive.Theestimatedintakeswerebasedon24hdataforfoodconsumption,whichtendtoexaggeratetheestimatedintakesbyconsumersathigh
percentiles.TheestimatedintakesexceededtheADIevenbeforeadditiontonationalassessmentsofthecontributionfromwater(3mgofnitriteonthebasisof
consumptionof1lofwaterperdayandthemaximumnationalguidelinelevelinwater).
ThepercentcontributionofeachfoodgrouptototalintakewasalsopresentedintheAustralianandNewZealandassessments.Fornitrate,thegreatestcontributorbased
onnationalpermissions(notincludingwater)wasprocessedcomminutedmeatproducts(Australia,56%NewZealand,52%),andthegreatestcontributorbasedon
maximumpermittedlevelsintheGSFAandnationalfoodconsumptiondatawasrawmeat,poultryandgame(Australia,55%NewZealand,51%).Fornitrite,the
greatestcontributorbasedonnationalpermissions(notincludingwater)wasprocessedmeatinwholecutsorpiecesforAustralia(58%)andprocessedcomminutedmeat
productsforNewZealand(60%),andthegreatestcontributorbasedonGSFAandnationalfoodconsumptiondatawasrawmeat,poultryandgame(Australia63%New
Zealand,60%).Astheseassessmentsdidnotincludeintakesfromsourcesotherthanadditives,includingvegetablesandwater,theestimatedcontributionsofthesefood
categorieswouldbedifferentifconsideredinthecontextoftotaldietaryintakesfromallsources.
Insummary,theestimatedintakesofnitrateinAustraliaandNewZealandwerebelowtheADIonthebasisofnationalandGSFAmaximumpermittedlevels.Similar
estimatesofnitritewereabovetheADIonthebasisofnationalandGSFAmaximumpermittedlevels.Theresultsoftheseassessmentsareoverestimatesastheydonot
includetheconcentrationsoftheadditivesinfoodsasconsumedhowever,theresultsdidnottakeintoaccountsourcesotherthanfoodadditives.Forthesereasons,itis
difficulttoderivemeaningfulconclusionsorrecommendationsfromtheaboveresults.
3.3Intakefromallsources
TheresultsoftheintakeassessmentsfromthetotaldietstudiesintheUnitedKingdom,basedonmeasuredconcentrationsinfoods,indicatedthattheintakesofnitrate
andnitritebyconsumersatthemeanandhighpercentilesinallthemodeldietsassessedwerebelowtherespectiveADIs(Table9).Theintakesrepresented75%ofthe
ADIfornitrateand70%oftheADIfornitrite.
Foodsthatmadeamajorcontributiontothemeanestimatedpopulationdietaryintakeofnitrateweregreenvegetables,potatoesandothervegetables(total,69%inthe
1997totaldietstudyand76%inthe1994totaldietstudy).Fornitrite,thehighestcontributortothemeanestimatedpopulationdietaryintakewasbeverages(specific
typesnotstated),accountingfor35%inthe1997totaldietstudyand30%inthatin1994.
ThestudyofnitrateinduplicatedietsofvegetarianssubmittedbytheUnitedKingdomindicatedestimatedintakesbelowtheADIforallconsumers(Table12).Theper
centcontributionswerenotprovidedforindividualfoodshowever,foodcontributedthemosttothemeanestimatedintake(62%),withwatercontributing24%andbeer,
13%.Measurementinaduplicatedietover7daysisconsideredtobearelativelyaccuratemethodforestimatingfoodchemicalintake.A7daystudydoeshavethe
limitationthatsomerespondentsunderreportfoodconsumptionorchangetheirdietarypatternshowever,theresultswerebasedonlyonduplicatedietsthatwere
validatedasbeingrepresentativesamples.Thesamplesizeinthissurveywasrelativelysmall(35respondents)andmaynotberepresentativeofallvegetarians.This
studysuggeststhatintakeofnitrateandnitritebyvegetariansisnotnecessarilyhigherthanthatofthegeneralpopulation.
TheduplicatedietstudysubmittedbytheNetherlandsshowedestimatedintakesforconsumersofnitrateatthemeanandconsumersofnitriteatthemedianthatwere
belowtheADI(30%oftheADIfornitrate,5%oftheADIfornitrite).ThenitrateintakeswereslightlyhigherthanintheduplicatedietstudyintheUnitedKingdom,
perhapsbecauseofthedurationofthesurvey:thestudyintheNetherlandslasted24h,whilethatintheUnitedKingdomlasted7daysandisthereforemore
representativeofusualintake,providingabetterestimateoflongtermintakes.Theintakesofnitratebyfiveconsumers(4%ofrespondents)andofnitritebyfour
consumers(3%ofrespondents)exceededtheADI,onthebasisof24hintake.Theseestimatesarelikelytohavebeenloweroveralongerperiod.Themajorcontributors
tonitrateintakewereleafyvegetables,beetrootandgreenbeans(nopercentagesgiven).Themajorcontributorstointakeofnitritewerenotgiven.
Insummary,theresultsofstudiesoftheintakeofnitrateandnitritefromalldietarysourcesshowedmeanconsumptionsofbothbelowtheADIs,althoughsome
consumersathighpercentilesexceededtheADIforbothchemicals.
4.CONCLUSIONSANDRECOMMENDATIONS
Theseconclusionsarebasedonthelimiteddatathatweresubmitted.TheintakeofnitratewasreportedtobebelowitscorrespondingADImoreoftenthanthatofnitrite.
Theestimatedintakesofnitrateshowthatvegetablesarethemajorcontributortototaldietaryintake,followedbywater.Themajorcontributorstonitriteintakearealso
sourcesotherthanadditives,includingcereals,beveragesandwater.Foodscontainingnitrateandnitriteasfoodadditivesarenotmajorcontributorstothetotalestimated
intakeinthesubmitteddata.
IntakeestimatesbasedonnationalandGSFAmaximumpermittedlevelsshowedthattheintakeofnitrateisnotlikelytoexceedtheADIinanyscenarioorpopulation
assessed.Incontrast,theintakeofnitritewasshowntoexceedtheADIinallscenariosandforallpopulationsassessed.However,theseestimatesareoverestimatesas
theyarenotbasedonactualconcentrationsinfoodsasconsumed.
Theintakesofnitratebasedonmoreaccuratemethods,includingtotaldietstudiesinwhichmeasuredconcentrationsareused,areagoodindicationofintakefromthe
totaldiet.ThetotaldietstudiessubmittedindicatedthattheintakesofbothnitrateandnitritewerebelowtheADI.Theduplicatedietstudyindicatedthattheintakeof
consumersatahighpercentileapproachesandinsomecasesexceedstheADI.
Nitrite
Ideally,allsourcesofnitriteshouldbeincludedinanintakeassessmenthowever,onlyfoodandwaterwereincludedintheassessmentsmadeatthismeeting.Theintake
ofnitritefromnonfoodadditivesources,onthebasisoftheconcentrationsinfoodderivedfromEuropeanstudiesandtheGEMS/Foodregionaldietsandwithan
additionforwaterwasbelowtheADI(4050%oftheADIforthevariousdiets).Majorcontributorstotheestimatedintakefromsourcesotherthanfoodadditivesare
cereals(3560%oftheestimatedintake)andwater(2040%oftheestimatedintake).
TheestimatedintakesfromuseofnitriteasafoodadditivederivedfromnationalassessmentswereabovetheADI,assumingmaximumlevelsintheCodexdraftGSFA.
Theintakeofnitritebyconsumersatthemeanrepresented460500%oftheADI,whilethatofconsumersatthe95thpercentilerepresented13001400%oftheADI.
TheintakesofnitritefromfoodadditiveusebasedonmaximumpermittedlevelsinnationalstandardsalsoexceededtheADI(consumersatthemean,100130%ofthe
ADIconsumersatthe95thpercentile,320360%oftheADI).TheestimatedintakesbasedontheGSFAdonotreflectreality,asthecalculationsincludetheGSFA
maximumlevels,whichoftenaresignificantlyhigherthanthetypicallevelsofadditiontofoodsbymanufacturers.Thecalculationsalsodonottakeintoconsideration
degradationofnitriteovertimeanddonotreflecttheconcentrationsinfoodsasconsumed.Theintakesarebasedon24hfoodconsumptiondata,whichtendtoresultin
overestimatesofintakebyconsumersathighpercentiles.
Morerealisticestimatesoftheintakeofnitritefromalldietarysources,submittedintotaldietandduplicatedietstudies,showedmeanintakesrepresenting515%ofthe
ADI,althoughtheintakesbyconsumersathigherpercentilesapproachedtheADIandexceededitinonestudy,representing55330%oftheADI.Amajorcontributorto
thetotalintakeestimatedfromthesestudieswasbeverages(specifictypesnotstated),whichaccountedfor3035%ofthetotalestimatedintake,owingmoretothehigh
volumesconsumedthantohighconcentrationsofnitrite.Analysedconcentrationsinfoodsasconsumedwereusedinthesestudies.Theseresultsconfirmthatthe
estimatesofintakefromuseofnitriteasafoodadditiveatthelistedmaximumlevelsintheGSFAornationalmaximumpermittedlevelsareoverestimates.
Nitrate
Ideally,allsourcesofnitrateshouldbeincludedinanintakeassessmenthowever,contributionsfromairwerenotincludedhere.Nitrateintakefromsourcesotherthan
foodadditives,basedonconcentrationsinfoodderivedfromEuropeanstudiesandtheGEMS/Foodregionaldietsandwithanadditionforwater,wasbelowtheADI
(1070%oftheADIforthevariousdiets).Majorcontributorstointakewerevegetables(3065%oftheestimatedintake)andwater(545%oftheestimatedintake).The
nitratecontentofbothgroundwaterandsurfacewaterishighlyvariable,andwidevariationsareseenbetweencountries.
TheestimatedintakesfromuseofnitrateasafoodadditivederivedfromnationalassessmentswerebelowtheADI,assumingthemaximumlevelsintheCodexdraft
GSFA.Theintakebyconsumersatthemeanwasabout10%oftheADI,whiletheintakeofthoseatthe95thpercentilewas3035%oftheADI,onthebasisofnational
dataonfoodconsumption.TheintakesofnitratefromfoodadditiveusebasedonmaximumpermittedlevelsinnationalstandardswerealsobelowtheADI(consumersat
themean,10%oftheADIconsumersatthe95thpercentile,35%oftheADI).Majorcontributorsfromitsuseasafoodadditivewereprocessedcomminutedmeatsin
nationalassessments(5055%ofestimatedintake)andrawmeatsonthebasisofGSFAmaximumlevels(5055%oftheestimatedintake)fromnationalfood
consumptiondata.Theseintakeswerebasedon24hfoodconsumptiondata,whichtendtoresultinoverestimatesoftheintakeofconsumersathighpercentiles.
Assessmentsofintakeofnitratefromalldietarysources,includingdrinkingwater,showedthattheywerebelowtheADI.IntotaldietstudiesintheUnitedKingdom,the
meanintakeswerebetween40%and45%oftheADIandthosebyconsumersatthe95thpercentilewere6075%oftheADI.Duplicatedietstudiesshowedmean
intakesrepresenting3035%oftheADIandintakesbyconsumersatthe95thpercentilerepresenting95125%oftheADI.Thesestudiesincludedoneofvegetarians,
whoarelikelytohavehigherintakesofnitrateowingtotheirgreaterconsumptionofvegetableshowever,theirintakeswerenotconsiderablydifferentfromthoseofthe
generalpopulation.Majorcontributorstototaldietaryintakeofnitratewerevegetables,whichaccountedfor7075%ofthetotalestimatedintake.TheCommitteenoted
thatthefoodadditiveuseofnitateisnotamajorsourceofintake.
4.1Generalrecommendation
TheCommitteerecommendedthatassessmentsoftheintakeofnitrateandnitriteshouldincludesourcesotherthanfoodadditives,suchasvegetablesanddrinkingwater,
aswellasfoodadditives.Studiesshouldbeconductedwithanaccuratemethodofassessment,suchastotalorduplicatedietsandindividualdietaryrecords,asthesegive
thebestestimatesofintakes.Also,foodsshouldbeanalysedasreadytoconsume,thusaccountingforlossesofthechemicalsduringfoodstorage,preparationand
cooking.Thisappliesspecificallytonitrite.Studiesshouldbeconductedduringdifferentseasonstoaccountfornaturalvariationintheconcentrationsinfoodssuchas
vegetables,particularlyfornitrate.
4.2RecommendationstotheCodexCommitteeonFoodAdditivesandContaminants
TheCommitteerecommendedthattheCodexCommitteeonFoodAdditivesandContaminantsreconsiderthemaximumpermittedlevelsofnitrateandnitriteinthedraft
GSFA,astheestimatedintakesofnitrateandnitritemightexceedtheADI.
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SeeAlso:
ToxicologicalAbbreviations