WHOFOODADDITIVESSERIES:50

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.

5.REFERENCES
Branen,A.L.,Davidson,P.M.&Salminen,S.,eds(1990)FoodAdditives,NewYork:MarcelDekker.
CooperativeResearchCentreforWaterQualityandTreatment(1996)FactSheetsInorganicChemicals(FactSheetNumber61),Canberra.
Coultate,T.C.(1989)Food.TheChemistryofitsComponents,London:RoyalSocietyofChemistry.
Dich,J.,Jrvinen,R.,Knekt,P.&Penttil,P.L.(1996)Dietaryintakesofnitrate,nitriteandNDMAintheFinnishMobileClinicHealthExaminationSurvey.FoodAddit.
Contam.,13,541552.
EuropeanCommission(1998)FoodScienceandTechniques.ReportsoftheScientificCommitteeforFood(ThirtyeighthSeries),Luxembourg.
FoodSafetyAuthorityofIreland(2001)Legislation,IntakeandUsageofFoodAdditivesinIreland,Dublin.
Hansen,S.C.(1979)Conditionsforuseoffoodadditivesbasedonabudgetmethodforanacceptabledailyintake.J.FoodProt.,42,429434.
InstituteofMedicine(1996)FoodChemicalsCodex,4thEd.,WashingtonDC:NationalAcademyPress.
deKreij,C.(1998)GoodAgriculturalPractice(GAP)inglasshouselettuceintheNetherlands.Registrationduring19951998,Internalreport149,Naaldwijk,
ProfstationvoorBlomisterijenGlasgroente.
deKreij,C.(2001)GoodAgriculturalPractice(GAP)inglasshouselettuceandspinachcultivationintheNetherlands.Registrationduring20002001,Naaldwijk,
AppliedPlantResearchB.V.
deKreij,C.&vanWinkel,A.(2000)GoodAgriculturalPractice(GAP)inglasshouselettuceandspinachcultivationintheNetherlands.Registrationduring1998
2000,Internalreport227(revisedversion),Naaldwijk,ProfstationvoorBlomisterijenGlasgroente.
Maga,J.A.&Tu,A.T.,eds(1995)FoodAdditiveToxicology,NewYork:MarcelDekker.
McKnight,G.,Smith,L.,Golden,M.N.H.&Benjamin,N.(undated)Metabolismofdietarynitrateinthegastrointestinaltractinman,StudyFS2188(1CO64),London:
MinistryofAgriculture,FisheriesandFood.
MinistryofAgriculture,FisheriesandFood(1996)NitrateinVegetables,FoodSurveillanceInformationSheetNo.91,July1996,London.
MinistryofAgriculture,FisheriesandFood(1997a)1994TotalDietStudyNitrateandNitrite,FoodSurveillanceInformationSheetNo.137,December1997,London.
MinistryofAgriculture,FisheriesandFood(1997b)1996/97UKMonitoringProgrammeforNitrateinSpinachandLettuce,FoodSurveillanceInformationSheetNo.
121,August1997,London.
MinistryofAgriculture,FisheriesandFood(1998a)SurveyofNitriteandNitrateinBaconandCuredMeatProducts,FoodSurveillanceInformationSheetNo.142,
February1998,London.
MinistryofAgriculture,FisheriesandFood(1998b)1997TotalDietStudyNitrateandNitrite,FoodSurveillanceInformationSheetNo.163,October1998,London.
MinistryofAgriculture,FisheriesandFood(1998c)1997/98UKMonitoringProgrammeforNitrateinLettuceandSpinach,FoodSurveillanceInformationSheetNo.
154,August1998,London.
MinistryofAgriculture,FisheriesandFood(1998d)NitrateinLettuceandSpinach,FoodSurveillanceInformationSheetNo.177,May1998,London.
MinistryofAgriculture,FisheriesandFood(1999)NitrateinVegetables,FoodSurveillanceInformationSheetNo.158,September1998,London.
MinistryofAgriculture,FisheriesandFood(2000)DuplicateDietStudyofVegetariansNitrateAnalyses,FoodSurveillanceInformationSheetNo.165,November
1998,revisedJanuary2000,London
MinistryofAgriculture,FisheriesandFood(2001)UKMonitoringProgrammeforNitrateinLettuceandSpinach,FoodSurveyInformationSheetNumber16/01,July
2001,London.
MinistryofHealth(2000)DrinkingwaterStandardsforNewZealand2000,Wellington.

NationalHealthandMedicalResearchCouncilandAgricultureandResourceManagementCouncilofAustraliaandNewZealand(1996)AustralianWaterQuality
Guidelines,Canberra.
vanderSchee,H.A.(1997)Report.NitrateMonitoringResultsConcerningRegulationEU194/97.TheNetherlands1996,Amsterdam:InspectorateforHealthProtection
.
vanderSchee,H.A.(1998)TheNitrateContentofVegetablesoftheDutchMarketin1996,Amsterdam:InspectorateforHealthProtection.
vanderSchee,H.A.&Speek,A.J.(2000a)ReportofNitrateMonitoringResultsConcerningRegulationEU194/97.TheNetherlands2000,Amsterdam,Inspectoratefor
HealthProtectionandVeterinaryPublicHealth,RegionNorthwest.
vanderSchee,H.A.&Speek,A.J.(2000b)ReportofNitrateMonitoringResultsConcerningRegulationEU194/97.TheNetherlands1999,Amsterdam,FoodInspection
AgencyNorthwest.
Tompkin,R.B.(1993)Nitrite.In:Davidson,P.M.&Branen,A.L.,eds,AntimicrobialsinFoods,2ndEd.,NewYork:MarcelDekker.
Vaessen,H.A.M.G.&Schothorst,R.C.(1999)TheoralintakeofnitrateandnitriteinTheNetherlands:evaluationoftheresultsobtainedbyHPICanalysisofduplicate
24hourdietsamplescollectedin1994.FoodAddit.Contam.,16,181188.
WHO(1998a)GuidelinesforDrinkingwaterQuality,2ndEd.,AddendumtoVolume2.HealthCriteriaandOtherSupportingInformation,Geneva.
WHO(1998b)GuidelinesforDrinkingwaterQuality,2ndEd.,AddendumtoVolume1.Recommendations,Geneva.
WHO(1998c)GEMS/FOODRegionalDiets,Geneva.
SeeAlso:
ToxicologicalAbbreviations