Quantitative Risk Assessment Relating to the Inadvertent Presence of Peanut Allergens in Various Food Products

7/28/2019 Quantitative Risk Assessment Relating to the Inadvertent Presence of Peanut Allergens in Various Food Products

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International Food Risk Analysis Journal

Quantitative Risk Assessment Relatingto the Inadvertent Presence of PeanutAllergens in Various Food ProductsRegular Paper

Loup Rimbaud1, Fanny Hraud1, Sbastien La Vieille2,Jean-Charles Leblanc1 and Amlie Crpet1,*

1 Risk Assessment Department (DER), French Agency for Food, Environmental and Occupational Health Safety (ANSES), Maisons-Alfort, France2 Bureau of Chemical Safety / Food Directorate, Health Canada, Ottawa, ON, Canada* Corresponding author E-mail: [email protected]

Received 14 Dec 2012; Accepted 12 Apr 2013

DOI: 10.5772/56646

2013 Rimbaud et al.; licensee InTech. This is an open access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract Since 2005, European food regulations require

majorallergens, includingpeanut, tobedeclaredon the

label where the allergen is intentionally present in the

food. However, even if not mentioned in the list of

ingredients,peanutallergenmaybeinadvertentlypresent

inalargerangeofpackagedfoodandconsequentlymay

affectmanypeanutallergicindividuals.

Thiswork

is

an

exercise

in

quantifying

the

allergic

risk

forpeanutallergicindividualsinFrancewhenexposedto

foodproductsthatmaycontainlowlevelofpeanutsdue

tocrosscontamination.Thisquantification isbasedona

probabilistic approach publishedby Rimbaud et al. in

2010 (Rimbaud et al. 2010). Foodproducts analysed for

the possible presence of peanut traces in scientific

literature were selected. For each foodstuff, the allergic

risk associated with their consumption was estimated

using the French individual food consumption survey,

representative of the general French population. An

internet survey on the attitudes of peanutallergic

individualstoward

food

precautionary

labelling

was

conducted.Forthreefoodstuffs,theallergicriskwasthen

refined integrating the information on specific food

behavioursofFrenchallergicindividuals.

Considering themean probability, inadvertent presence

of peanuts was identified in 20% to 37% of products.

Adultswereexposed toupto12.5mgofpeanutprotein

on 97.5% of their eating occasions. The mean risk of

reaction ranged from 0.2% to 2.4%. Considering eating

occasionsforalltheproducts,1.5%ofthepeanutallergic

adultswouldhaveatleastoneallergicreactioninaweek.

In undertaking this modelling exercise, we have

demonstrated the benefits of integrating all available

informationtounderpindecisionmakingintheareaoffood

allergencrosscontamination.Wehavealsohighlighted the

need to generate more data to further refine the risk

assessmentforthebenefitofallergicconsumers.

Keywords Allergen Exposure, Food Risk Assessment,

Peanut Allergy, Precautionary Labelling, Statistical

Modelling

1Loup Rimbaud, Fanny Hraud, Sbastien La Vieille, Jean-Charles Leblanc and Amlie Crpet: Quantitative Risk

Assessment Relating to the Inadvertent Presence of Peanut Allergens in Various Food Products

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ARTICLE

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1.Introduction

Inwesternized countries, food allergies are estimated at

levelsup to56% foryoungchildrenand34% foradults

(Zuberbieretal.2004;Osterballeetal.2005;Lucciolietal.

2008;Venter

et

al.

2008).

InFrance,

food

allergy

affects

approximately3.2%ofthepopulation,i.e.nearly2million

people (Kanny et al. 2001). Among the different food

allergens,peanutisthemostcommonlyreportedcauseof

severe and fatal allergic reactions (e.g. Bock et al. (2007)

report16fatalitiesfrompeanut,followedbytreenuts,milk

and shrimp). Peanut is associated with half of food

anaphylaxis cases and themajority of consequentdeaths

(Ranc and Bidat 2000; Werfel 2008). Furthermore, the

elicitingdoseofpeanutproteinforanallergicreactioncan

beextremelylow,aslittleas1mg(Hourihaneetal.2005).

ThepeanutallergyprevalenceinFranceisestimatedtobe

0.3%of

adults

aged

18

to

79

years

and

0.6%

of

children

aged3to17years,combiningtheobservationsofRancet

al.(2005)andMoneretVautrin(2008).

The European Directive 2003/89/EC, amended by the

Directive 2007/68/EC, requires labelling of 14 allergens,

including peanut,when used in the formulations of pre

packaged foods. This measure allows peanutallergic

individuals to avoid peanutcontaining foods and

consequently improves thepreventionofallergic reactions

(ANSES2008).Nevertheless,ariskofreactiontopeanutstill

remains, as small amounts of peanut allergens may

inadvertentlyoccur

in

commercially

packaged

food

products.Lowlevelpresenceofpeanutproteinsmayresult

from contamination of the raw material or from cross

contaminationby the shareduse ofprocessing equipment

(Rder et al. 2008). In such situations, peanut is not

mentionedon therequired listof ingredientsbutproducts

canhaveaprecautionarystatementlabelledasmaycontain

peanut. The impact of the masked allergens (including

misunderstanding labelling, missing information, new

formulation, error of labelling and crosscontamination) is

important,sinceitisestimatedtohaveinduced8.6%ofthe

seriousallergicreactionsreportedbytheFrenchfoodallergy

networkbetween

2001

and

2006

(ANSES

2008).

In

attempting to prevent inadvertent exposure to allergen

crosscontamination among allergic consumers, food

manufacturersfrequentlyuseprecautionarylabellingtoalert

consumers topotential allergen hazards in foodproducts.

However,duetooveruseoftheseprecautionarystatements,

such labelling leads to adilemma for allergic individuals:

eithertheybecomelessobservantofhazardsbyconsuming

suchproducts,ortheyacceptadrasticreductionindietary

choice. Additionally, it has been shown that allergic

consumers are increasingly ignoring precautionary labels

(Hefleetal.2007).

Allergencrosscontaminationalsopresentsachallengefor

theriskassessmentduetointerindividualheterogeneityin

allergen thresholds, and the wide range of allergen

concentrations in food products. In an exposure model

basedon the classicdeterministic approach, inputvalues

areexpressedas singlevaluesorpointestimates,usually

representing a worst case scenario. Quantitative risk

assessmentbased

on

probabilistic

principles

is

emerging

as

thepreferredapproach (Madsenetal.2009).Probabilistic

modelling has the capacity to use data distributions

representing variability and uncertainty in input

parameterswhich increasestheunderstandingandclarity

oftherelationshipbetweenvaluesandrisk.

Aprobabilisticmodel forquantifying theriskofallergic

reaction topeanutdue to the consumption of chocolate

tablets(i.elargebarsofwhite,darkormilkchocolate)has

been previously developed (Rimbaud et al. 2010). This

modelcouplesBayesian inferenceof inputvariablesand

second

order

Monte

Carlo

simulations

to

separately

propagate variability, i.e. for one side natural

heterogeneityordiversity,andforothersideuncertainty

duetomeasurementerrorsormodelhypotheses(Pouillot

etal.2007).

This paper demonstrates the process of capturing andincorporating data from various sources, in a structured

way, tosupport riskbaseddecisionmaking in relation to

allergencrosscontamination.Theobjectiveofthisstudyis

toapplythismodeltoarangeoffoodproductswhichhave

been analysed for peanut contamination in scientific

literature,suchaschocolatetablets,chocolatebars,biscuits,

breakfastcereals,

bakery

products,

confectionery,

snacks

andprocesseddesserts.Theallergicriskwasestimatedfor

eachproductseparately.To take intoaccount the specific

consumptionbehavioursofpeanutallergicindividuals,an

internetsurveywasalsoconducted inorder todocument

theirattitudestowardfoodprecautionarylabelling.

2.Materialsandmethod

2.1Dataandvariablesofthemodel2.1.1PresenceandconcentrationofpeanuttracesinfoodproductsData

relating

to

inadvertent

presence

of

peanut

allergens

in food products were collected from the scientific

literature (PubMedandScopusdatabases).Eightarticles

relating to the detection and quantification of peanut

allergens in food using commercially available test kits

(the EnzymeLinked ImmunoSorbent Assay method,

ELISA,andthePolymeraseChainReactionmethod,PCR)

were considered.Results on 926 samples purchased on

European and NorthAmerican markets were gathered

and classified into eight food groups: chocolate tablets,

chocolate bars, biscuits, cereals, bakery products,

confectionery, snacks and processed desserts (Table 1).

When

the

information

was

available,

the

products

were

also classifiedaccording to thepresenceorabsenceofa

precautionarylabelling.

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TotalWith traces of

eanut (%)Total Min Max Total Min Max

Chocolate

tabletsb 275 100 (36.4%) 202 81 40.1% 0.17 24.1 72 19 26.4% 0.17 74

(Holzhauser and Vieths, 1999; Keck-

Gassenmeier et al., 1999; Pel et al., 2007;

Stephan and Vieths, 2004)h

Chocolate barsc 69 25 (36.2%) 27 8 29.6% 4 72.5 37 17 45.9% 5 245

(Vadas and Perelman, 2003; Yeung and

Collins, 1996)

Biscuits 317 80 (25.2%) 138 29 21.0% 0.17 5.8 175 51 29.1% 0.17 5.8

(Holzhauser and Vieths, 1999; Keck-

Gassenmeier et al., 1999; Pel et al., 2007;

Schppi et al., 2001; Stephan and Vieths,

2004; Yeung and Collins, 1996)h

Cerealsd 78 15 (19.2%) 69 29 42.0% 0.72 1160 9 4 44.4% - -

(Hefle et al., 2007; Holzhauser and Vieths,

1999; Schppi et al., 2001; Stephan and

Vieths, 2004)

h

Bakery products 56 0 (0.0%) 47 0 0.0% - - 6 0 0.0% - - (Hefle et al., 2007; Schppi et al., 2001)h

Confectionerye 43 8 (18.6%) 38 8 21.1% 0.72 945.4 2 0 - -

(Hefle, 2007; Holzhauser and Vieths,

1999;Keck-Gassenmeier, 1999;Stephan and

Vieths, 2004 )h

Snacksf 64 12 (18.8%) 37 1 2.7% 2.9 18.3 22 11 50.0% - -

(Yeung and Collins 1996; Schppi et al. 2001;

Hefle et al. 2007)h

Processed

dessertsg 24 0 (0.0%) 9 0 0.0% - - 5 0 0.0% - -

(Yeung and Collins 1996; Holzhauser and

Vieths 1999; Keck-Gassenmeier et al. 1999;

Stephan and Vieths 2004; Hefle et al. 2007)h

Total 926 240 (25.9%) 567 156 27.5% 0.17 1160 328 102 31.1% 0.17 245

Number of samples

Concentra-

tion

With traces

of peanut

Number of samplesNumber of samplesReferences

Concentra-

tion

(mgkg-1)a (mgkg-1)a

With traces

of peanut

Product

groups

All data Labelling related to peanut traces No reference to peanut

aincontaminatedproducts,Min=minimum,Max=maximum

b(tabletssuchasplainchocolate,wholemilkchocolate,semisweetchocolate,etc.)c(suchasMars,Bounty,Lion,etc.)

d(breakfastcerealsandcerealbars)e(candies,confectionery,etc.)f(potatochips,corncrackers,instantmeals,etc.)

g(nougatbars,yoghurt,pudding,applesauce,etc.)hconcentrationvaluesoriginallyexpressed inmgkg1of totalpeanutmaterialandconverted intoaproteinequivalentusinga factoruniformlydrawn

between24%and29%(cf.Rimbaudetal.(2010))

Table 1.Contaminationof 926 samplesbypeanut inpublisheddata:numberof samples containingdetected tracesofpeanut andconcentrationofpeanutproteinincontaminatedsamplesforeachoftheeightproductcategoriesanddetailedper labellingwhenthe

informationwasavailable.Inonearticle(Schppietal.2001),onlytheprobabilityofpresencewasretainedbecausetheconcentrationof

peanutallergensincontaminatedsampleswasinsufficientlyprecise.

The binary variable P indicating whether the product

containspeanuttraces(P=1)ornot(P=0)ismodelledbya

Bernoullidistribution

with

probability

p

(Table

2).

The

probabilitypismodelleditselfbyaBetadistributionwith

parameters (; ). If theproduct containspeanut traces,

theconcentrationlevelsCexpressedmg.kg1isconsidered

distributedwithanexponentialdistributionwithparameter

representingtheinverseofthemean. ismodelledbya

Gamma distribution with parameters (; ). The

parameters of the distributionswere estimated through

theBayesianapproachdevelopedinRimbaudetal.(2010)

applied to all data presented in Table 1. It results in

valuesof(; )and(; )presentedinthecolumnAll

inTable2foreachproductsgroup.Forchocolatetablets,

chocolatebarsandbiscuits, thenumberofdataper type

of precautionary labelling was sufficient to provide a

specific distribution related to the labelling (columns

precautionarylabellingandnoreferencetopeanutin

Table2).

2.1.2Consumptionpattern

The consumption pattern is provided by the French

individual food consumption survey INCA2, conducted

in20062007by theFrenchFoodSafetyAgency (ANSES

2009;ANSES2009a).2624adultsaged18to79yearsand

1455 children aged 3 to 17 years, representative of the

general French population, were asked to complete a

sevenconsecutiveday fooddiary.Participantsestimated

portion sizes through comparison of their actual

consumption with photographs compiled in a manual

adapted from theSuViMaxpicturebooklet (Hercberget

al.

1994).

Consumed

quantities

of

products

by

allergic

individuals were considered to be equivalent to those

consumedbytheINCA2populationgroup.Inthecontext



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ofanacuteriskassessment,thelargestamountofproduct

ingestedby each individual on a single eating occasion

during the sevenday period recorded was used. The

descriptive statistics of the empirical distribution of this

largestamountareshowninTable3forboth adultsand

childrenpopulations.

Description DistributionorequationWhether the product iscontaminated (P=1) or not

(P=0)

P~Bernoulli(p)withE(P)=p

Probabilityofpresence

ofpeanut(%)p~Beta(; )withE(p)=/(+)

Labellingrelatedtopeanuttraces

Parameters

(; ) of the

distribution

ofp

Product

groupsPrecautionarylabelling Noreferencetopeanut All

Chocolate

tablets(82;122) (20;54) (101;176)

Chocolate

bars(9;20) (18;21) (26;45)

Biscuits (30;110) (52;125) (81;238)

Cereals (16;64)

Confectionery (9;46)

Snacks (13;53)

Peanut

concentration

(mgkg1)

C~Exp()withE(C)=1

Parameter of the

distributionofC ~Gamma(; )withE()= /

Labellingrelatedtopeanuttraces

Parameters

(;)of the

distributionof

Product

groupsPrecautionarylabelling Noreferencetopeanut All

Chocolate

tablets(42;279) (11;152) (53;420)

Chocolate

bars(8;297) (17;846) (24;1143)

Biscuits (11;86) (31;97) (42;183)

Cereals (22;1277)

Confectionery (16;1578)

Snacks (8;20)

Consumedportionof

product(kg)Q:largestobservedquantitiesduringthesevendayperiodrecordedinINCA2survey

Equationofthedose

responsecurve(cumulative

distributionfunctionofthe

thresholdofreactionT)

ad

bDR d 1 e

Thresholdofreaction(mg) T~Weibull(a;b)withE(T)=b(1+1/a)

Parameters(a;b)ofthe

distributionofT

a~ED*

b~ED*

Exposuretopeanut

allergens(mg)E=PxCxQ

Risk(probabilityofallergic

reactionin%)R=DR(E)

Occurrenceofatleast1

allergicreaction

intheweek

S=1 if E T

S=0 otherwise

Whethertheconsumerpays

attentiontoprecautionary

labelling(PA=1)ornot

(PA=0)

PA~Bernoulli(p)withE(PA)=p

Observedprobabilityof

payingattentiontolabellingp

*EmpiricalDistributionobtainedinTable4of(Rimbaudetal.2010).

Table2.Descriptionofthevariablesandtheparametersoftheallergenriskmodel



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Product Variable Population Mean SDa p2.5b Median p97.5b

Chocolatetablets

p (%) 36% 3% 31% 36% 42%

C(mgkg1) 8.3 8.3 0.2 5.7 30.1

Q(g)Adults 25.0 32.0 3.0 13.0 111.0

Children 26.0 23.0 5.0 20.0 93.0

E(mg)

Adults 0.2 0.4 2.4E

03

0.08

1.1Children 0.2 0.3 2.8E03 0.09 1.1

Chocolatebars

p (%) 37% 6% 26% 37% 48%

C(mgkg1) 49.6 51.4 1.2 33.7 188.9

Q(g)Adults 53.0 36.0 5.0 50.0 150.0

Children 42.0 26.0 7.0 40.0 112.0

E(mg)Adults 2.9 3.3 0.08 1.7 11.4

Children 2.0 2.6 0.05 1.1 8.6

Biscuits

p (%) 25% 2% 21% 25% 30%

C(mgkg1) 4.6 4.8 0.1 3.1 17.5

Q(g)Adults 49.0 44.0 5.0 36.0 168.0

Children 53.0 35.0 10.0 50.0 140.0

E(mg)Adults 0.2 0.4 2.4E03 0.1 1.2

Children 0.2 0.3 4.1E03 0.1 1.1

Cereals

p (%) 20% 4% 12% 20% 29%

C(mgkg1) 65.4 68.7 1.6 44.0 250.4

Q(g)Adults 53.0 33.0 15.0 45.0 125.0

Children 48.0 24.0 15.0 45.0 100.0

E(mg)Adults 2.9 3.6 0.08 1.8 12.5

Children 2.9 3.5 0.06 1.7 11.8

Confectionery

p (%) 20% 6% 10% 20% 33%

C(mgkg1) 104.3 110.1 2.6 69.4 400.8

Q(g)Adults 24.0 36.0 3.0 13.0 80.0

Children 24.0 25.0 3.0 20.0 80.0

E(mg)Adults 2.2 4.1 0.03 0.8 11.4

Children 2.1 3.2 0.03 1.0 10.8

Snacks

p (%) 20% 5% 11% 19% 30%

C(mgkg

1) 2.8 3.3 0.1 1.7 11.5

Q(g)Adults 28.0 28.0 5.0 20.0 87.0

Children 32.0 33.0 5.0 20.0 132.0

E(mg)Adults 0.08 0.1 1.4E03 0.04 0.4

Children 0.07 0.1 1.3E03 0.03 0.3

p:probabilityofpresenceofpeanutallergens

C:Peanutconcentration

Q:Consumedportionofproduct

E:Strictlypositivelevelsofexposuretopeanutallergensastandarddeviation

b2.5thand97.5thpercentilesofthedistribution

Table 3. Descriptive statistics of the model variables for each of the six products: probability of the presence of peanut allergens,concentrationofpeanutproteinincontaminatedproducts,largestportionoffoodingested,andexposuretopeanutproteinsfollowing

theconsumptionofacontaminatedproduct

2.1.3Attitudesofpeanutallergicconsumerstowards

precautionarylabelling

Attitudes of peanutallergic consumers were described

through an internet survey conducted fromJanuary to

June2009onchocolateproductsandbiscuits.Theallergic

individualsvisitingthewebsiteoftheFrenchAssociation

for Allergy Prevention (AFPRAL) were invited to

respond toaquestionnaire. Individualswere firstasked

whether they had eliminated chocolate products and

biscuits from their diet. Then, subjects who had not

eliminated

these

products

were

asked

whether

they

pay

attention to food labelling, and, if so, to detail their

relative consumption frequency of: i) productsbearing

labelling such as peanutfree, ii) products with

precautionarylabellingsuchasmaycontainpeanutand

iii) products without any reference to peanut on their

packaging. One hundred and thirty five peanutallergic

children aged 1 to 17 years old and 68 peanutallergic

adults completed the questionnaire.Respondents

attitudes were assumed tobe representative of those of

thepeanutallergicpopulationinFrance.

2.1.4Doseresponseforpeanutallergen

The doseresponse curve is definedby the relationship

betweentheintakeofagivenamountofallergenandthe

proportionofallergicindividualsthatarelikelytoreact.



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It is statistically represented by the cumulative

distribution function of the threshold of reaction. The

modelling of a doseresponse curve from published

thresholds of reaction of the DoubleBlind Placebo

ControlledFoodChallenge(DBPCFC)testsdevelopedin

Rimbaud et al., 2010,was retained and summarized in

Table2.Asproposedbytheauthors,onedoseresponse

curvebasedonpooleddataforbothadultsandchildren

populationswasusedinthisstudy.

2.2ExposureandriskassessmentTheindividualexposureisdefinedbytheamountinmgof

peanutallergen ingestedpereatingoccasionofaproduct

among the six groups. It is estimated in combining the

probability that the consumed product contains peanut

allergen, its correspondingpeanut concentration and the

consumed quantity. The allergic risk to peanut is then

definedastheprobabilitythatanallergicconsumerreacts

following an exposure topeanut allergen.Practically the

exposure is null when the consumed product is not

contaminated(P=0).Otherwise(P=1),theexposurelevelE

results from the multiplication of the largest portion of

productingestedinoneeatingoccasionbyan individual,

Q, with a level of peanut C randomly selected in its

correspondingdistribution.Then,theprobabilityofreaction

associatedwiththisindividualexposureleveliscalculated

usingtheequationofthedoseresponsecurveDR(E)given

in Table 2. These calculations are repeated for each

individualofthesurveyINCA2andeachproductgroupto

obtainadistributionoftheriskassociatedwithoneeatingoccasion.This process is performed 100 times using 100

different values of parameters distributions and leading

witha95%credible interval foreachestimateof the risk

distribution.

Inordertoestimatethenumberofconsumerswhowould

haveatleastoneallergicreactiontopeanutinoneweek,

the exposures related to each eatingoccasionof the six

product groups in one week were calculated for each

individual.Inparallel,athresholdofreactionselectedin

its corresponding Weibull distribution (Table 2) was

attributed

to

those

individuals.

If

at

least

one

exposure

levelrelatedtothedifferenteatingoccasionsequalledor

exceededthethreshold,theindividualwasconsideredto

have one allergic reaction during the week. Note that

each eating occasion was taken into account

independently. The simultaneous consumption of

different products during a meal and therefore their

associatedriskwerenotconsidered.

Usingthisdata,twoscenarioswerestudied:thefirstone

considered that allergic consumers had no specific

attitudetowardthedifferentprecautionarylabelling;and

the

second

one

integrated

their

specific

attitude

as

declared in the internetsurvey. In the firstscenario, the

probabilityofcontaminationandtheconcentrationlevels

weresimulatedregardlessofthetypeoffoodlabelling.In

this way, the common distributions of these variables

fitted from all thedata (column All inTable 2)were

used tosimulate theexposure. In thesecondscenario,a

supplementary variable, PA, indicates whether the

consumer pays attention to labelling (PA=1), or not

(PA=0). The variable PAwas generatedby aBernouilli

distributionwithparameterp,estimatedbytheobserved

frequencyofcarefulbehaviourobtainedfromtheinternet

survey. IfPA=1, theprobabilityofpeanutpresenceand

the concentration level were simulated given the

frequencies of consuming productbearing labelling or

not, from the specific contamination distributions

(columnsprecautionary labellingandnoreferenceto

peanut in Table 2). The guaranteed peanutfree

productswereassumedtonotcontainanytraceofpeanut

and therefore the risk associated with this type of

products

is

null.

The

second

scenario

was

applied

only

on

chocolate tablets, chocolatebars andbiscuits forwhich

specificconsumerattitudedistributionswereavailable.

2.3ComputingtoolsTo estimate the parameters of the input variable

distributionsof themodel,Bayesian computationswere

performed using the WinBUGS software (version 1.4,

Imperial College & Medical Research Council (MRC),

UK) asdescribedbyRimbaud et al., 2010.Using theR

software (version 2.5.0, R Foundation for Statistical

Computing),peanutexposureandriskweresimulatedby

secondorder Monte Carlo algorithm as described by

Rimbaudetal.(2010).

3.Results

3.1ContaminationandconsumptionestimatesBasedondatausedinthisstudy,chocolatebarswerethe

most likely contaminated products (Table 3), with an

average probability of peanut presence of 37%. This

probabilityhasa95%chanceoffallingbetween26%and

48%,which represents itsuncertainty.Chocolate tablets

contamination was of the same order of magnitude.

Concerningtheotherproducts,onequarterofthebiscuits

and one fifth of the cereals, the confectionery and the

snacks contained peanut allergens and may therefore

induceariskofallergicreaction.

Whentracesofpeanutwerepresentinaproductsample,

theconcentrationofpeanutproteinreachedheterogeneous

levels,dependingontheproduct.Forinstance,theaverage

incontaminatedconfectionerywas104.3mgkg1ofpeanut

protein, i.e. the equivalent of one peanut kernel in one

kilogramoffood.Theconcentrationlevelwasgreaterthan

400.8mgkg1 for2.5%of thecontaminatedconfectionery.

In

contrast,

the

concentration

averaged

2.8

mg

kg1

for

the

contaminatedsnacks,and2.5%ofthemhadconcentrations

greaterthan11.5mgkg1.



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Regarding the consumption pattern, the largest amount

consumedbyadults inanyonesitting inaweekaveraged

approximately50g for thechocolatebars, thebiscuitsand

thecereals.Thesewerefollowedbythesnacks,thechocolate

tabletsandtheconfectionery,averaging28g,25gand24

g,respectively.

The

children

consumed

similar

quantities

totheadultpopulationgroup.

3.2Estimatesoftheexposure,risk,andnumberofallergicreactionspereatingoccasionwithoutintegratingspecificattitudestowardthedifferentprecautionarylabellingWhen the consumed sample is contaminated, the

highestexposurelevelisfromcereals,withanaverage

of2.9mgforadultsand2.9mgforchildren(Table3).

Adultsandchildrenwereexposedtomorethan12.5mg

and11.8mgof peanutprotein,respectively, from 2.5%

of the contaminated cereal portions. Concerning the

otherproducts,theaverageexposurelevelrangedfrom

0.08 mg (snacks) to 2.9 mg (chocolatebars) of peanut

proteinfor

adults,

and

from

0.07

mg

(snacks)

to

2.1

mg

(confectionery)forchildren.It is important tonote that

97.5%of thepopulationisexposed toalevelbelow the

peanut concentration of 12.5 mg reached in one eating

portion of contaminated cereals. Nevertheless, 12.5 mg

of peanut protein is sufficient to trigger an allergic

reaction in 15.5% to 16.5% of the peanutallergic

population, according to the doseresponse curve

previouslyestablished(Rimbaudetal.2010).

Product Population Estimator Mean SDa Median p97.5b Positiveriskmeand

Chocolatetablets

Adults

Median 0.6% 1.1% 0.0% 3.6% 1.5%

2.5%c 0.4% 0.9% 0.0% 2.9% 1.3%

97.5%c 0.7% 1.3% 0.0% 4.4% 1.9%

Children

Median 0.6% 1.1% 0.0% 3.9% 1.7%

2.5%c 0.5% 0.9% 0.0% 3.1% 1.5%

97.5%c 0.8% 1.3% 0.0% 4.7% 2.0%

Chocolatebars

Adults

Median 2.4% 4.0% 0.0% 12.8% 6.6%

2.5%c 1.5% 3.0% 0.0% 9.6% 5.0%

97.5%c 3.6% 5.2% 0.0% 17.2% 8.1%

Children

Median 2.0% 3.3% 0.0% 10.7% 5.4%

2.5%c 1.3% 2.6% 0.0% 8.3% 4.3%

97.5%c 2.8% 4.1% 0.0% 13.6% 6.8%

Biscuits

Adults

Median 0.4% 1.0% 0.0% 3.3% 1.7%

2.5%c 0.3% 0.8% 0.0% 2.6% 1.4%

97.5%c 0.5% 1.2% 0.0% 4.0% 2.0%

Children

Median 0.5% 1.0% 0.0% 3.4% 1.8%

2.5%c 0.4% 0.8% 0.0% 2.9% 1.5%

97.5%c 0.6% 1.2% 0.0% 4.3% 2.2%

Cereals

Adults

Median 1.4% 3.3% 0.0% 11.4% 6.8%

2.5%c 0.7% 2.3% 0.0% 8.2% 5.2%

97.5%c 2.3% 4.6% 0.0% 15.8% 9.2%

Children

Median 1.4% 3.2% 0.0% 11.2% 6.6%

2.5%c 0.8% 2.4% 0.0% 8.3% 5.3%

97.5%c 2.1% 4.1% 0.0% 14.2% 8.2%

Confectionery

Adults

Median 1.0% 2.8% 0.0% 9.5% 5.2%

2.5%c 0.5% 1.9% 0.0% 6.0% 4.0%

97.5%c

2.0% 4.4% 0.0% 13.7% 6.7%

Children

Median 1.1% 2.8% 0.0% 9.6% 5.3%

2.5%c 0.5% 2.0% 0.0% 7.1% 4.3%

97.5%c 2.1% 4.3% 0.0% 14.4% 6.9%

Snacks

Adults

Median 0.2% 0.5% 0.0% 1.7% 1.0%

2.5%c 0.1% 0.3% 0.0% 1.1% 0.7%

97.5%c 0.4% 1.0% 0.0% 3.3% 1.8%

Children

Median 0.2% 0.5% 0.0% 1.5% 0.9%

2.5%c 0.1% 0.3% 0.0% 1.0% 0.7%

97.5%c 0.3% 0.7% 0.0% 2.4% 1.4%astandarddeviation

b97.5thpercentilesofthedistribution

c2.5%and97.5%valuesdefinea95%credibleintervalaroundtheestimatewiththemedian

dmeanofthestrictlypositiveriskvalues

Table4.Descriptivestatisticsoftheriskofallergicreactiontopeanutpereatingoccasionassociatedwitheachofthesixproducts,foradultandchildpeanutallergicpopulationgroups



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Population Numberofindividuals Estimator

Individualswithreactiona

Number %Adults

(18 79

years)

2624

Median 40 1.5%

2.5%b 29 1.1%

97.5%b 56 2.1%

Children

(3 17years)1455

Median

54

3.7%

2.5%b 36 2.5%

97.5%b 77 5.3%

aindividualswithatleastonereactionduringtheweek

b 2.5% and 97.5% values define a 95% credible interval around the

estimatewiththemedian

Table 5. Number of consumers who would have at least oneallergic reaction to peanut in one week from among the 2624

adultsand1455children,consideringalltheeatingoccasionsof

alltheproductsthroughouttheweek

Focusing on the chocolate bars, and including both

contaminated and noncontaminated samples, the

probabilityof

allergic

reaction

to

peanut

averaged

2.4%

pereatingoccasion,witha95%credibleinterval(CI95)of

[1.5; 3.6]% for adults (Table 4). The median of the risk

equalled zero, meaning that at least 50% of the eating

occasions inducednoriskofreaction.However,2.5%of

the adults had a risk greater than 12.8% (CI95:

[9.6;17.2]%).Theprobabilityofallergicreactionfollowing

the consumption of a contaminated chocolate bar

averaged6.6%(CI95:[5.0;8.1]%).Nosignificantdifference

wasobservedbetweenchildrenandadults.Inthismodel,

the chocolatebars induced thehigher risk, followedby

cereals, confectionery, chocolate tablets, biscuits and

finally

snacks.

TheriskforthewholeFrenchpeanutallergicpopulation

canbeextrapolatedtakingintoaccounttheprevalenceof

peanutallergy in thegeneralpopulation.The11,792,146

French children agedbetween 3 and 17 years and the

46,758,489 French adults agedbetween 18 and 79 years

(INSEE2009)

were

multiplied

by

the

prevalence

and

the

mean risk of allergic reaction per eating occasion.

Therefore, assuming that the whole allergic population

consumeschocolatebars,3,713adults(CI95:[2,312;5,485])

and 1,372 children (CI95: [900; 1,974]) would have a

reaction to peanut, including severe and nonsevere

incidents. This corresponds to respectively 2.0%

(CI95:[1.3;2.8]%) and 2.4% (CI95:[1.5;3.6]%) of the total

adult and child peanutallergic population groups in

France.

3.3NumberofindividualswithallergicreactioninoneweekConsidering

all

the

eating

occasions

of

all

the

studied

products, 40 adults and 54 children among the INCA2

population group would have at least one reaction to

peanutinoneweek(Table5).Thisrepresentsrespectively

1.5% (CI95: [1.1;2.1]%) and 3.7% (CI95: [2.5;5.3]%)of the

adultandchildpeanutallergicpopulationgroups.

Product Population Estimator Mean SDa Median p97.5b Positiveriskmeand

Chocolatetablets

Adults

Median 0.4% 1.0% 0.0% 3.4% 1.7%

2.5%c 0.3% 0.8% 0.0% 2.6% 1.4%

97.5%c 0.5% 1.3% 0.0% 4.4% 2.0%

Children

Median 0.4% 1.1% 0.0% 3.5% 1.8%

2.5%c 0.3% 0.9% 0.0% 2.9% 1.5%

97.5%c 0.6% 1.3% 0.0% 4.5% 2.1%

Chocolatebars

Adults

Median 1.9% 3.7% 0.0% 12.0% 6.6%

2.5%c 1.2% 2.6% 0.0% 8.6% 5.0%

97.5%c 2.8% 4.8% 0.0% 15.9% 8.3%

Children

Median 1.3% 2.8% 0.0% 9.4% 5.2%

2.5%c 0.9% 2.1% 0.0% 7.3% 4.3%

97.5%c 1.9% 3.6% 0.0% 12.3% 6.6%

Biscuits

Adults

Median 0.3% 0.9% 0.0% 2.9% 1.7%

2.5%c 0.2% 0.7% 0.0% 2.3% 1.4%

97.5%c 0.4% 1.1% 0.0% 3.8% 2.1%

Children

Median 0.3% 0.9% 0.0% 3.1% 1.8%

2.5%c 0.2% 0.7% 0.0% 2.4% 1.5%

97.5%c 0.5% 1.2% 0.0% 4.3% 2.4%

astandarddeviation

b97.5thpercentileofthedistribution

c2.5%and97.5%valuesdefinea95%credibleintervalaroundtheestimatewiththemediandmeanofthestrictlypositiveriskvalues

Table6.Descriptivestatisticsoftheriskofallergicreactiontopeanutpereatingoccasionforchocolatetablets,chocolatebarsandbiscuits

including

the

attitudes

towards

food

precautionary

labelling



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concentrations for the formers. If these differences also

exist with the French market, the risk may have been

overestimated. This points to the need for data on the

presence of allergens in food at the national level.

Moreover,riskcalculationscanalsoberefinedifsufficient

datacanbecollectedtodistinguishcontaminationbetweenproductswithandwithoutprecautionarylabelling.

Anothersourceofoverestimationisduetotheselectionof

patients in the DBPCFC tests. Indeed, patients who

participate in clinical tests often feel very concernedby

their food allergy and theymaybemore reactive (have

lower thresholds) than the general allergic population

group.AsdiscussedbyRimbaudetal.(2010),thisseemsto

beparticularly the case for adults.Basedon thedatawe

collated from the published literature, we found the

thresholdsofreactionforadultstobelowerthanthosefor

children(data

not

shown),

which

is

not

in

accordance

with

clinicaldata(MoneretVautrinandKanny2004;Hourihane

etal.2005).Toreducethisimpact,theresultsofadultsand

childrenDBPCFCtestswerepooledtoestablishonesingle

doseresponse curve.Moreover, the results of this study

havetobemoderatedbecauseallthresholdsassociated to

various types of reaction from nonsevere incidents (oral

itching for example) to serious event (anaphylaxis),were

treatedequivalentlyinthiswork.Effortstoacquiredataon

thresholds of reaction will permit to refine allergic risk

assessmentby integrating data on the severity of allergy.

Moreover,thisstudyhasrevealedanimpactofconsumption

behavioursonriskestimates, thereforeasurveycombining

consumptionbehavioursandthresholdsofallergicsufferers

willbethemostappropriatetorefineriskassessment.

This approach can be implemented as a tool for risk

managers, manufacturers or public administrations.

Indeed,aretrocalculationbasedonthedefinitionofan

acceptable risk could help to decide whether to use

precautionary labelling. Moreover, for physicians, the

exposureestimatescanactasaguidelinewhendefining

allergen doses for DBPCFC tests, a dosing scheme

corresponding to the real exposure scheme.Finally, this

approachcouldalsobeappliedtoguidethephysiciansto

make recommendations to their patients based onquantified results such as to avoid specific products

consideringtheirindividualclinicalthreshold.

5.Acknowledgment

The authors wish to thank the French Association for

AllergyPrevention (AFPRAL) for theirjointeffort to the

internet survey on food behavior of people with food

allergies.

6.Disclosureofpotentialconflictofinterest

Theauthors

have

declared

that

they

have

no

conflict

of

interest

7.Abbreviations

AFPRAL FrenchAssociationforAllergyPrevention

ANSES French Agency for Food, Environmental and

OccupationalHealthSafety

CI9595%

credible

interval

DBPCFC DoubleBlindPlaceboControlledFoodChallenge

ELISA:EnzymeLinkedImmunoSorbentAssay

PCR:PolymeraseChainReaction

8.References

[1]AFPRAL. (2009). Website. Retrieved Jun 15, 2009,fromhttp://www.afpral.asso.fr.

[2]ANSES (2008). (French Agency for Food,EnvironmentalandOccupationalHealthSafety).Food

allergiesandadvisorylabelling.MaisonsAlfort.

[3]ANSES(2009).(Agencefranaisedescuritsanitaire,alimentation, environnement, travail). Rapport de

ltude Individuelle Nationale des Consommations

Alimentaires2.MaisonsAlfort.

[4]ANSES (2009a). (French Agency for Food,Environmental and Occupational Health Safety).

INCA2(20062007).ReportoftheIndividualandthe

NationalStudyonFoodConsumption.199p.

[5]ANSES(2009b).(Agencefranaisedescuritsanitaire,alimentation, environnement, tavail). Analyse des

rsultatsduneenquteANSES/AFPRALportantsurle

comportementalimentairedespersonnesallergiques

larachide visvis de produits potentiellement

contamins.MaisonsAlfort.

[6]Dutau,G.andF.Ranc(2001). Allergielarachide.Revue Franaise dallergologie et dimmunologie

clinique41:187198.

[7]Bock, S.A,MunozFurlongA., SampsonH.A. (2007)Furtherfatalitiescausedbyanaphylacticreactionsto

food,20012006JAllergyClinImmunol119(4):1016

1018.

[8]Hefle, S. L., T.J. Furlong, L. Niemann, H. LemonMule,S.SichererandS.L.Taylor(2007). Consumer

attitudes and risks associatedwith packaged foods

having advisory labeling regarding the presence of

peanuts.JAllergyClinImmunol120(1):171176.[9]Hercberg,S.,M.DeheegerandP.Preziosi(1994).SU

VIMAX.Portionsalimentaires.Manuelphotospour

lestimationdesquantits,EditionsPolyTechnica.

[10]Holzhauser, T. and S. Vieths (1999). Indirectcompetitive ELISA for determination of traces of

peanut (Arachis hypogaea L.) protein in complex

foodmatrices.JAgricFoodChem47(2):603611.

[11]Hourihane,J.o.B.,K.E.Grimshaw,S.A.Lewis,R.A.Briggs,J.B.Trewin,R.M.King,S.A.KilburnandJ.

O.Warner(2005). Doesseverityoflowdose,double

blind, placebocontrolled food challenges reflect

severityof

allergic

reactions

to

peanut

in

the

community? ClinExpAllergy35(9):12271233.



11/11

[12]INSEE.(2009). Bilandmographique2008.RetrievedJun15,2009,from

http://www.insee.fr/fr/themes/detail.asp?reg_id=99&

ref_id=bilandemo.

[13]Kanny, G., D. A. MoneretVautrin, J. Flabbee, E.Beaudouin, M. Morisset and F. Thevenin (2001).Population study of food allergy in France. J

AllergyClinImmunol108(1):133140.

[14]KeckGassenmeier, B., S. Bnet, C. Rosa and C.Hischenhuber(1999). Determinationofpeanuttraces

infoodbyacommerciallyavailableELISAtest. Food

andAgriculturalImmunology11(3):243250.

[15]Luccioli,S.,M.Ross,J.LabinerWolfeandS.B.Fein(2008). Maternallyreportedfoodallergiesandother

foodrelated health problems in infants:

Characteristics and associated factors. Pediatrics

122(2):105112.

[16]Madsen,C.B.,S.Hattersley,J.Buck,S.M.Gendel,G.F.Houben,J.O.Hourihane,A.Mackie,E.N.Mills,P.Norhede, S. L. Taylor and R. W. Crevel (2009).

Approaches to risk assessment in food allergy:

report from aworkshop developing a framework

for assessing the risk from allergenic foods. Food

ChemToxicol47(2):480489.

[17]MoneretVautrin, D. A. (2008). Epidmiologie delallergiealimentaire. RevueFranaisedallergologie

etdimmunologieclinique48:171178.

[18]MoneretVautrin,D.A.andG.Kanny(2004). Updateonthresholddosesoffoodallergens:implicationsfor

patients

and

the

food

industry.

Curr

Opin

Allergy

ClinImmunol4(3):215219.

[19]Osterballe,M., T.K.Hansen,C.G.Mortz,A.Hstand C. BindslevJensen (2005). The prevalence of

foodhypersensitivity inanunselectedpopulationof

children and adults. Pediatric Allergy and

immunology16:567573.

[20]Pel,M.,M.Brohee,E.AnklamandA.J.VanHengel(2007). Peanut and hazelnut traces in cookies and

chocolates: relationship between analytical results

anddeclarationoffoodallergensonproductlabels.

FoodAdditContam24(12):13341344.

[21]Pouillot, R., N. Miconnet, A. L. Afchain, M. L.DelignetteMuller,A.Beaufort,L.Rosso,J.B.Denis

andM.Cornu (2007). Quantitative risk assessment

of Listeria monocytogenes in French coldsmoked

salmon: I. Quantitative exposure assessment. Risk

Anal27(3):683700.

[22]Ranc, F. and E. Bidat (2000). Allergie alimentairechezlenfant,Mdecine&Hygine,Chapter5,p71.

[23]Ranc,F.,X.GrandmottetandH.Grandjean (2005).Prevalence and main characteristics of

schoolchildren diagnosed with food allergies in

France. ClinExpAllergy35(2):167172.[24]Rimbaud,L., F.Hraud, S.LaVieille,J.C.Leblanc

andA.Crpet (2010). Quantitative risk assessment

related to adventitious allergens in food: a

probabilisticmodelapplied topeanut in chocolate.

RiskAnalysis30(1):719.

[25]Rder,M.,A. Ibach, I. Baltruweit,H. Gruyters,A.Janise, C. Suwelack, R.Matissek, S. Vieths and T.

Holzhauser (2008). Pilot plant investigations on

cleaning efficiencies to reduce hazelnut cross

contamination inindustrialmanufactureofcookies.

JFoodProt71(11):22632271.

[26]Schppi,G.F.,V.Konrad,D. Imhof,R.EtterandB.Wuthrich (2001). Hiddenpeanutallergensdetectedin various foods: findings and legal measures.

Allergy56(12):12161220.

[27]Stephan,O.andS.Vieths (2004). DevelopmentofarealtimePCRandasandwichELISAfordetectionof

potentially allergenic trace amounts of peanut

(Arachishypogaea)inprocessedfoods. JAgricFood

Chem52(12):37543760.

[28]Vadas, P. and B. Perelman (2003). Presence ofundeclaredpeanutproteininchocolatebarsimported

fromEurope.JFoodProt66(10):19321934.

[29]Venter,

C.,

B.

Pereira,

K.

Voigt,

J.

Grundy,

C.

B.

Clayton,B.Higgins,S.H.ArshadandT.Dean(2008).

Prevalence and cumulative incidence of food

hypersensitivity inthefirst3yearsoflife. Allergy63

354359.

[30]Werfel, T. (2008). Food allergy. J Dtsch DermatolGes6(7):573583.

[31]Yeung, J. M. and P. G. Collins (1996). Enzymeimmunoassay for determination of peanut proteins

infoodproducts.JAOACInt79(6):14111416.

[32]Zuberbier,T.,G.Edenharter,M.Worm, I.Ehlers,S.Reimann, T.Hantke, C. C. Roehr, K. E. Bergmann

and B. Niggemann (2004). Prevalence of adverse

reactions tofood inGermany Apopulationstudy.

Allergy59:338345.



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