WORLD TRADE G/SPS/GEN/52
25February 1998
ORGANIZATION(98-0761)
Original: Spanish Committee onSanitary andPhytosanitary Measures
DRAFT ECREGULATION -AFLATOXIN CONTROL
Submission byArgentina
Thefollowing communication wasreceived from Argentina on13February 1998.
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Proposal bytheCommission oftheEuropean Communities toAmend Regulation
(EC) 194/97 of31January 1997 Setting Maximum Levels for
Certain Contaminants (Aflatoxins) inFoodstuffs
Purpose
Thepurpose isdescribed inthepreamble tothedraftRegulation asfollows:
Paragraph (1)"Whereas some member States haveadopted, orplantoadopt, maximum levels
foraflatoxins incertain foodstuffs;"
Paragraph (2)"Whereas, inviewofthedisparities between member States andtheconsequent
riskofdistortion ofcompetition, Community measures arenecessary inorder toensure market
unity while abiding bytheprinciple ofproportionality;"
Paragraph(3)"Whereasruleshavetobesetconcerningthemaximumlimitswhichareacceptable
insingle dried and/or processed agricultural products andincompound foodstuffs inorder
toensure human health protection aswellasproper functioning ofthesingle market withregard
tosuchproducts".
Products concerned: Cereals, groundnuts, fresh fruits andmilkproducts.
Annexes
Draft ..."Proposal concerning methods ofsampling andmethods ofanalysis ofthecontent
ofcontaminants incertain foodstuffs" withAnnex (I)"Methods ofsampling fortheofficial control
ofthelevels ofaflatoxins incertain foodstuffs" andAnnex (II)"Sample preparation andcriteria for
themethods ofanalysis fortheofficial control ofthelevels ofaflatoxins incertain foodstuffs".
Entry intoforce: March 1998
Here below isadescription ofthetechnical andlegal elements which form thebasis for
Argentina 'sobjection tothisdraft.G/SPS/GEN/52
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Introduction
Aflatoxins aretoxins produced bythesecondary metabolism ofcertain fungi ofthegenus
Aspergillusandarenaturallypresentinmostcereal(maize),oilseed(groundnuts)anddriedfruit(walnuts,
chestnuts, etc.)crops. Thedistribution ofthese fungi isuniversal, andtheyoccur inallhabitats in
which thementioned crops arecultivated.
Thedevelopment ofthese fungi andtheformation oftheirtoxins areinfluenced byvariations
inthenatural environment, suchastemperature andhumidity, affecting thedifferent stages ofthe
cultivation process, andofthepost-harvest period (storage, transport, etc).
Theoccurrence ofthetoxins isdiminished considerably bygoodcultivation andpost-harvest
practiceswhich,althoughtheycannotensurecompleteelimination,helptomaintainreasonableacceptance
levels.
Fiveaflatoxins havebeenidentified: B1,B2,G1andG2incereals, groundnuts, andnuts, and
M1inmilk.
Atthecultivation stage, thespread ofaflatoxins isfavoured byexcessive humidity during the
formation andripening ofthegrain, severe drought, insect infestations ordelay intheharvest with
thepossibility oflaterain,etc.
Thedistribution ofaflatoxins, bothduring cultivation andstorage, isentirely random: itis
anegative binomial distribution, andnotagaussian oneasinmostbiological phenomena. Thismeans
thatspecific sampling plans mustbedevised inorder todetect andquantify theoccurrence ofaflatoxins;
samples must betaken from goods onthemove atgiven intervals.
Toxicological background
In1987,the31stMeetingoftheWorldHealthOrganizationconcludedthattherewasinsufficient
information toestablish a"tolerable level" ofintake.
InJune1992, aworking group oftheInternational Agency forResearch onCancer (IARC)
drew upareport assessing carcinogenic riskstohuman beings inwhich itconcluded thatthere was
sufficient evidence ofcarcinogenicity inhuman beings ofmixtures produced naturally fromaflatoxins
andfrom aflatoxin B1inparticular.
Inthepress report ofthe46thMeeting oftheWorld Health Organization, aflatoxins appear
among themostpotent carcinogenic andmutagenic substances known, particularly inconnection with
livercancer (based onexperimental evidence).
Atthesametime, thedifferent reports oftheWHO andtheJointFAO/WHO Expert Committee
onFood Additives (JECFA) associated thecarcinogenicity ofaflatoxin B1withthehepatitis Bvirus
(HBV) andhence withthelevels ofvaccination against hepatitis B.Andinfact,thepopulation of
theEUhasoneofthehighest vaccination levels intheworld against hepatitis B.
Inthereport ofthe49thmeeting ofJECFA, heldinJune1997, theCommittee considered
thattheweightofthescientificevidence,whichincludedepidemiologicaldata,laboratoryanimalstudies,
andinvivoandinvitrometabolism studies, supported theconclusion thataflatoxins should betreated
ascarcinogenic foodcontaminants, theintake ofwhich should bereduced tolevels aslowasreasonably
achievable.G/SPS/GEN/52
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Thisreport marks achange ofposition, inthelightofthescientific evidence, asregards the
regulation ofaflatoxins. JECFA 's1989 report recommended thatthelevelofaflatoxin intake should
bereduced toirreducible values, i.e.alevelatwhich asignificant quantity oftheproducts inquestion
would havetobedestroyed. JECFA 'scurrent position (June 1997) isthataflatoxin intake should be
reduced toaslowalevelasreasonably achievable.
Twofactors make thisconceptual change onthepartofJECFA particularly significant:
1. Thelowtolerable levels ofintake (those currently being developed fortheCodex
Alimentarius andthose proposed bytheEU)donotresult inasignificant enough
difference interms ofriskevaluation toprovide ascientific justification forsucha
reduction.
2. Theconcept ofreasonably achievable levels implies weighing thetoxicological aspects
against production aspects, andhence thesupply offoodstuffs, withaviewtoachieving
afairbalance.
Sampling plans
Thesampling planproposed bytheEUcontains alotofnewelements thatarenotbacked by
aninternational bibliography anddonottakeaccount ofthepractical aspects ofhandling anenormous
quantity ofsamples; moreover, theacceptance/rejection criteria areclearly biased infavour ofthe
importer.
According tothissampling plan, ifoneofthethree subsamples shows avalue exceeding the
setlimit, theentire lotmust berejected, eveniftheaverage level ofthethree subsamples isbelow
thesetlimit. Thismeans thatrisksarenotequal fortheexporter andtheimporter.
Fromtheeconomicpointofview,thedraftEURegulationimplies,attheveryleast,asignificant
costincrease duetothesampling process alone, nottomention therejection oflargevolumes ofsamples
uponloadingandunloading,theevaluationofalternativeusesoftherawmaterial,possibledetoxification,
etc.
In1993, theFAO consulted anumber ofinternational experts regarding sampling plans for
theanalysis ofaflatoxins ingroundnuts andmaize, theresults ofwhich werepublished inFAO Food
andNutrition Paper No.55.
Thepaper contains ananalysis oftheoccurrence ofaflatoxins ingroundnuts andmaize traded
internationally andofthedevelopment andevaluation ofsampling plans withastudy ofcharacteristic
performancecurvesandtheoreticalprobabilitymodels,andprovidesrecommendationsforsampletaking
andpreparation.
Thetechnical consultations revealed thatthesampling plans mustbesimple, mustprovide for
relatively large samples and,contrary totheEUproposal, boththeexporter andtheimporter must
besubjected tothesame risk.
Codex Alimentarius
Thissubject iscurrently being discussed infourCommittees: theCodex Committee onFood
AdditivesandContaminants(CCFAC),theCodexCommitteeonCereals,PulsesandLegumes(CCCP L),
theCodex Committee onFood Hygiene (CCFH) andtheCodex Committee onMethods ofAnalysis
andSamples (CCMAS). Itcomes within thedomain ofthefirsttwoCommittees inparticular, andG/SPS/GEN/52
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isthesubject ofagenda item12ofthenextmeeting oftheCCFAC tobeheldduring thefirsthalf
ofMarch ofthisyear.
Thework ofthese Committees began afewyears ago,andefforts tosetacceptance/rejection
levels encountered problems dueessentially todiverging views between exporting andimporting
countries. Alargenumber ofcountries participate inthemeetings, andpintheirhopes onthepossibility
ofadopting recommendations thatwillberespected byallmembers. They consider theseCommittees
tobetheappropriate forum forscientific discussions concerning foodstandards ininternational trade.
Conclusions
- Themaximum limits proposed bytheEUarewithout scientific justification interms ofrisk
totheconsumer, andconsequently, maybeconsidered asrepresenting apara-tariff barrier
tointernational trade. Assuch, theywould beviolating theprinciples oftheWTO Agreement
ontheApplication ofSanitary andPhytosanitary Measures (Article 2.2,2.3and2.4;Article 3.2
and3.3; Article 5.1,5.2,5.3,5.4and5.5; andArticle 6.1).
Indeed, although theproposal isostensibly based onscientific arguments, itstruejustification
liesintheneedfortheEUtoharmonize thelegislations ofitsdifferent member States, particularly
withtheincorporation oftheScandinavian countries whose regulations arestricter thanthose ofthe
southern States -afactwhich isperfectly understandable, since regions withacoldclimate donot
offerthenatural conditions fortheproliferation ofaflatoxins. Thisjustification canbeinferred from
thepreambular partoftheproposal (paragraphs 1,2and3).
Atthesame time, dueconsideration should begiven tothestudies oftheIARC, theresults
ofthe46thMeeting oftheWorld Health Organization, andthe49thReport oftheJECFA which takes
accountoftheepidemiologicalstudiesofriskallocationconcerningaflatoxins,tothefactthattheCCFAC
hasfound thatthere isinsufficient up-to-date information tosetmaximum limits fortotalaflatoxin
andB1levels, andthatonthebasisofthelatest studies, JECFA hasaltered its1989position andnow
mentions "reasonable values" instead of"irreducible values", aswellastothesampling plans proposed
byFAO/WHO studies andworkshops andtheinfeasibility ofimplementing theEUproposal.
Aflatoxins appear topresent alesser riskforhuman beings thanfortheanimals onwhich the
laboratory experiments were conducted, since theydonotmetabolize them inthesame way. The
experiments prove thataflatoxins present agreater riskinpopulations where hepatitis Bisendemic,
andthatforpopulations inregions suchasEurope, where hepatitis Bisrare,toreduce themaximum
levelofaflatoxins infoodstuffs from 20to10ppbwould yield anincrease intheriskoflivercancer
intwocases per1,000 million inhabitants (Report ofthe49thMeeting oftheFAO/WHO JECFA,
Rome, June1997).
- Thesampling planmentioned intheEUdrafthasnoscientific justification andisbiased in
favour ofoneoftheparties (exporting country-importing country); hence itisinconsistent
withthespirit andletter oftheAgreement onTechnical Barriers toTrade.
TheEuropean proposal would haveextremely serious consequences forsampling ofcereal
andgroundnut shipments inthatitwould increase thenumber ofsamples asmuch assix-fold, thus
constituting atruetechnical barrier totrade. Atthesametime, themaximum limits foraflatoxin content
intheEuropean proposal areveryclose totheminimum levels detectable through normal methods
ofanalysis without considering thenatural margin oferror ofsuchmethods.G/SPS/GEN/52
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Here, onceagain, thedraftlacks technical foundation anditsimplementation isunrealistic in
that:
- Itcallsforadisproportionate increase inthenumber ofsamples tobetaken forthe
detection ofaflatoxins;
- themethods usedhaveaveryhighmargin oferror, which means thatthelower the
maximum tolerated level, thelesssignificant thedifference between analytical values;
- itimplies averyhighcostwhich would notonlyaffect exporters, butwould bereflected
intheprice paidbyconsumers.
Thedamage toourcountry would beconsiderable inviewoftheimpact thattheimplementation
ofsuchameasure would produce (seeattached table). Although soyabeans andsoyaandsunflower
mealarethechiefexports totheEUinterms ofvolume, bothmaize andgroundnuts aswellastheir
by-products represent aconsiderable share ofexport revenue.
Inthespecificcaseofflintmaize,theproductreactsverywelltoextrusionandisusedprincipally
fortheproduction ofcornflakes. Between April andDecember 1997, thevolume offlintmaize exported
totheEUtotalled about 400,000 tonnes, exceeding theaverage of200,000 to300,000 tonnes exported
during previous periods. According tomarket estimates, there should beaconsiderable increase in
viewofthegrowing interest ofEuropean consumers, andthefigure could reach 800,000 tonnes per
year.
Finally, itshould beborne inmind thatthismatter iscurrently being studied anddiscussed
intheappropriate international scientific fora(FAO/WHO Codex Alimentarius) andthefuture agenda
provides forcontinued discussions onthesubject. Itwould beinappropriate toanticipate theconclusions
ofthose discussions, anditisimportant thattheyberespected.G/SPS/GEN/52
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VALUE OFARGENTINE EXPORTS OFCEREALS, GROUNDNUTS AND
BY-PRODUCTS THEREOF TOTHE EUROPEAN UNION
(Thousands ofdollars)
1997* 1996 1995 1994
Maize 73,049 99,606 76,813 65,070
Other cereals 94,281 9,250 5,303 14,995
Groundnuts 32,838 119,518 76,041 62,512
Bran 1,730 1,599 1,622 1,270
Groundnut by-products 7,692 9,649 3,989 3,997
Miscellaneous by-products 2,356 12,456 12,966 12,413
TOTAL 188,897 (?) 252,078 176,734 160,257
*Period January-July.
Source: Secretariat ofAgriculture, Livestock andFisheries.G/SPS/GEN/52
Page7ARGENTINE EXPORTS OFCEREALS, GROUNDNUTS AND BY-PRODUCTS TOTHE EUROPEAN UNION
(Inthousands oftonnes)
PRODUCTS 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997(*)
Wheat 40.1 0.0 0.0 0.0 9.0 1.7 1.5 1.5 10.0 4.0 47.2 97.6
Maize 900.7 573.4 858.2 301.8 516.3 582.6 682.0 720.2 471.0 671.0 621.8 850.0
Sorghum 0.0 0.0 100.3 0.0 0.0 0.0 0.0 0.0 0.0 9.0 1.5 25.2
Groundnuts 95.9 94.0 85.6 57.8 71.5 52.4 9.7 0.0 38.0 54.0 139.8 102.5
Millet 28.9 42.8 61.3 22.8 39.6 40.8 29.9 28.9 38.0 21.0 31.8 29.6
Barley 0.0 0.0 25.4 0.0 10.0 0.0 17.3 24.1 0.0 0.0 0.0 22.0
Wheat
by-products418.6 75.7 124.6 92.4 63.6 14.2 0.0 50.8 20.5 28.0 13.6 0.0
Groundnut
by-products23.6 32.5 48.2 21.0 39.1 33.1 95.7 33.4 28.0 39.0 52.1 4.2
Cotton
by-products25.7 46.2 117.6 118.9 98.2 161.2 73.2 72.9 121.2 148.0 140.1 57.6
Maize
by-products0.0 0.0 117.7 110.2 112.4 115.9 291.1 106.1 130.8 122.0 76.7 95.3
Sorghum
by-products0.0 0.0 4.7 2.5 3.2 6.5 5.8 8.0 7.0 8.0 8.6 15.5
TOTAL: 1,533.5 864.6 1,543.6 727.4 962.9 1,008.4 1,206.2 1,045.9 864.5 1,104.0 1,233.2 1,299.5
Period January-November 1997
Rice-groundnuts: January-October 1997
Source: Department ofAgri-Food Markets -Secretariat ofAgriculture, Livestock andFisheries.
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