WORLD TRADE G/SPS/GEN/61
9March 1998
ORGANIZATION(98-0928)
Original: English Committee onSanitary andPhytosanitary Measures
DRAFT ECREGULATION -AFLATOXIN CONTROL
Submission byAustralia
Thefollowing communication wasreceived from Australia on5March 1998.
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ECNotification G/SPS/N/EEC/51: Comments byAustralia
1. Thefollowing comment byAustralia inrespect ofG/SPS/N/EEC/51 hasbeenforwarded to
theECenquiry point.
2. Thenotification relates specifically tothesetting ofmaximum limits foraflatoxin B1andtotal
aflatoxins ingroundnuts, dried fruit, cereals, milkandprocessed products thereof. Thestipulated
rationale forthissanitary measure ispublic health.
3. Itisconsidered unlikely thattheproposed maximum levels foraflatoxins willresult ina
significant reduction inhealth risktoECconsumers. Adraftreport oftheevaluation ofaflatoxin-related
health riskundertaken bytheJoint (FAO/WHO) Expert Committee onFood Additives (JECFA) in
June1997 supports thisposition. Thereport, while stating thataflatoxin levels should bereduced
aslowasreasonably achievable, alsoemphasizes thesignificant roleofhepatitis Binfection inthe
population asafactor inaflatoxin-induced human livercancer, andtheimportance ofvaccination in
reducing theincidence oflivercancer. Thereport states thatpopulations withalowprevalence of
hepatitis Bindividual and/or withalowmean intake (lessthan1ng/kg/ bw/day) areunlikely toexhibit
detectable differences inpopulation risksforstandards intherange 10-20 µg/kg. Thus, inEurope,
theproposed change tothestandard isunlikely tosignificantly reduce theriskoflivercancer.
4. Theproposed sampling procedure isunduly onerous andlikely tobecostly. Under theproposed
sampling planitisestimated thatupto75percentoflotsrejected would be"good lots". Ingeneral,
thesampling statistics ofaflatoxin detection areexceptionally difficult, especially given thatthe
uncertainty ofType 1andType 2errors increases significantly withlower limits. Weareoftheview
that15µg/kg isthelowest level thatcanbepractically andreliably metinanyenvironment which
haseffective regulatory surveillance.
5. Duetotheincreased statistical uncertainty, thecostofattempted conformance increases
disproportionately totheproposed decreased maximum level. Thiscostrelates toboththeincreased
number ofgood lotsrejected coupled tothelossinyield andincreased costofprocessing. Weare
oftheopinion thatthenumber ofdisputes willincrease dramatically duetotheincreased Type 2error.
Moreover, theability oftheEuropean Communities toapply thesame rigour totheirdomestic retail
surveillance isquestionable.
./.G/SPS/GEN/61
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6. FAO/WHO through theCode Committees onFood Additives andContaminants (CCFAC)
andCereal, Pulses andLegumes (CCCPL) haveattempted toharmonize aflatoxin sampling plans and
legallimits forpeanuts andother commodities. AnFAO/WHO Technical Consultation onSampling
Plans forAflatoxin Analysis inPeanuts andCorn evaluated theperformance of35aflatoxin sampling
plans using twosample sizes(5and20kg)andfiveaccept/reject limits ranging from 5to30µg/kg
totalaflatoxin. Asaresult ofthisprocess, theaflatoxin sampling plannowpending before CCFAC
totestrawshelledpeanutsforaflatoxinintheexport/importmarketusesthe20kgsampleanda15µg/kg
(total aflatoxin) accept/reject limit.
7. IntheECnotification therearenodetails ofariskassessment which wasundertaken tojustify
thereduction inaflatoxin levelfrom theCodex draftlimitof15µg/kg. Itistherefore notpossible
toestablish thatthelevelofprotection afforded bytheproposed ECstandard ismaterially different
tothatoftheCodex draftnorm presently under development, andunderpinned bytheJECFA risk
assessment.Accordingly,weinvitetheCommissiontoreconsideritspositioninrelationtothisproposed
standard.
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