WORLD TRADE G/SPS/GEN/54
20February 1998
ORGANIZATION(98-0623)
Original: English Committee onSanitary andPhytosanitary Measures
DRAFT ECREGULATION -AFLATOXIN CONTROL
Submission byIndia
Thefollowing communication wasreceived from India on13February 1998.
_________
Comments byIndiaontheproposed ECregulation amending Commission Regulation (EC)No.194/97
of31January 1997 setting maximum levels forcertain contaminants infoodstuffs
1. TheEuropean Commission 'sproposed amendment toitsexisting regulation No.194/97 of
31January1997,whichhasbeencirculatedasWTOdocumentG/SPS/N/EEC/51dated8January1998,
indicates thattheCommission isproposing toadopt anewregulation toestablish maximum limits for
aflatoxins incertain foodstuffs from March 1998.
2. India hasexamined thedraftECregulation andconsiders theproposed maximum limits for
aflatoxins ingroundnuts, nutsanddried fruitandprocessed products thereof; cereal andprocessed
products thereof; andformilkandmilkproducts tobeunjustifiably lowinrelation toconsumer aflatoxin
exposure andthepotential risk. India believes thatthese levels aresolowthattheywillinevitably
leadtoserious trade disruptions without acorollary increase inconsumer protection. Further, the
provisions formultiple sampling andanalysis willgreatly increase handling costswithnoappreciable
reduction ofaflatoxin contamination inconsumer products.
3. Indiaisalsoconcerned thatthesemeasures havebeennotified evenwhile theCodex Committee
onFood Additives andContaminants isseized ofthematter andhadinitsprevious meeting considered
theadoptionofsuitableinternationalstandardsforlimitingthelevelofaflatoxininvariousfoodproducts.
Infactthisissuefigures intheagenda circulated forthe30thSession oftheCodex Committee onFood
Additives andContaminants scheduled tobeheldinTheHague from 9-13March. Wefeelthatthe
ECproposal tonotify itsstandards, evenwhile theconcerned international body isaddressing this
issue, isnotappropriate, especially since themaximum permissible levels which theEuropean
Commission proposes toimplement aremuch higher/stringent thanthelevels which areunder
consideration intheCodex Committee.
4. Wearealsooftheviewthatsince thefoodproducts covered byEC'sproposed regulation are
extensively traded, itisimportant tomaintain abalance between theexport andimport ofthese items.
Setting verylowlimits ofaflatoxin forthese products would prove tobeabarrier totrade. EC's
proposal iscontrary totheCodex scientific principle ofdeciding thevalues based onacceptable daily
intake (ADI). TheEClimits arenotbased onacceptable dietary intake values andthestand taken
bytheEuropean Commission, thatthere isnothreshold ofaflatoxin below which noharmful effect
isobserved, requires proper scientific justification.
5. IndiawouldalsoliketohighlightthatArticle3.1oftheAgreementontheApplicationofSanitary
andPhytosanitaryMeasures(henceforthreferredtoas"theAgreement")specificallystatesthat"MembersG/SPS/GEN/54
Page2
shall base their sanitary andphytosanitary measures oninternational standards, guidelines or
recommendations". Though itcanbeargued thatnointernational standard exists atpresent, itisa
factthattheCodex Committee isinthefinalstages ofsetting aninternational benchmark inthisregard.
Even otherwise assuming thatthere isanimperative urgency fortheEuropean Commission to
'harmonize 'itsinternational standards, itmustbenoted thatithasbeenspecifically stipulated inthe
Agreement thatwhere international standards donotexistorwhere Members fixstandards higher than
existing international standards, theyshallensure thatsuchmeasures arebased onanassessment, as
appropriate tothecircumstances, oftheriskstohuman, animal orplantlifeorhealth. Suchascientific
assessment orriskanalysis doesnotappear tohavebeenundertaken.
6. Furthermore Article 5.4oftheAgreement directs that"Members should, when determining
theappropriatelevelofsanitaryorphytosanitaryprotection,takeintoaccounttheobjectiveofminimising
negative tradeeffects". Itisobvious thatinformulating thepresent regulation undue reliance hasbeen
placed onqualitative assessment which hasresulted inameasure which prescribes ahigher than
appropriate level ofprotection required. Itcontravenes theprovisions ofArticle 5.4which directs
Members tokeeptheobjective ofminimising negative trade effects firmly inviewwhile determining
theappropriate level ofsanitary orphytosanitary protection. These measures arealsoviolative of
Article 5.6oftheSPSAgreement which states "Members shallensure thatsuchmeasures arenotmore
trade-restrictive thanrequired toachieve theirappropriate levelofsanitary orphytosanitary protection"
inasmuch thattheywould haveasignificant negative trade impact.
7. Intheabove context Indiawould liketobring thefollowing factstothenotice oftheEuropean
Commission:
(a) Though aninternational standard ontheacceptable levelofaflatoxin infoodproducts
doesnotexistatpresent, theCodex Committee isseized ofthematter andwould be
considering itinitsforthcoming meeting scheduled from 9-13March 1998. We
therefore feelthatthetiming oftheEC'sproposed regulation, coming asitdoesjust
before theCodex Committee meeting, isinappropriate andthattheEuropean
Commission should waitforCodex tosettherequisite international standards.
(b) ThedraftECregulation doesnotgiveanydetails whatsoever oftheriskassessment
which mayhavebeencarried outtaking intoaccount available scientific evidence on
thebasis ofwhich these levels havebeenproposed. Thisisspecially important since
theEuropean Commission isproposing tosetmuch more stringent levels, asfaras
thepermissible limits ofaflatoxin areconcerned, incomparison tothestandards that
arecurrently being followed internationally.
(c) ThedraftECregulation doesnotgivethedetails oftheproposed sampling procedure.
Itis,however, learnt thattheECregulation proposes tostipulate thetaking ofthree
samples allofwhich musttestlessthanthepermissible limitofaflatoxin, forthelot
tobeaccepted. India feelsthatthesampling planiscostly, burdensome andunjust;
thatitwillnotinanywayincrease consumer protection andinstead willhaveanadverse
impact ontheprice ofthecommodity. Ontheother hand, itwould putundue burden
onsuppliers thereby distorting trade bylimiting thevolume andnumber ofsuppliers
whocanroutinely meet thiscriteria. Moreover, thesampling planwould mean an
unnecessary waste ofgoodmaterial without actually improving consumer safety. The
latest JECFA study published inJune1997shows thatanincrease intheupper ceiling
oftotalaflatoxin from10ppbto20ppbwould theoretically increase theriskofliver
cancer byonlytwoadditional casesannually, peronebillion population inindustrialised
countries.G/SPS/GEN/54
Page3
(d) Moreover, thesampling planstipulated intheproposed ECregulation hasserious
negative trade effects asitleads towastage ofmaterial fitforhuman consumption to
theextent of75percentofthequantity andaddstothecost. Thesampling plan
proposed is,therefore, costly, burdensome andunjust.
(e) Asregards theproposed maximum levels ofaflatoxin inmilk, itisourviewthatfixing
thisatalevelof0.05ppbisfartoostringent andnotbased onanyscientific dataor
clinical studies regarding riskmanagement. Further, suchaprotection levelappears
tobebased onunrealistic assumptions. Inthecaseofmilkitisunderstood thatthe
calculation forMIMRLs forallcontaminants/pesticides arebased onthemaximum
consumption figures of1,500 grammes perperson perday,which is7-8times higher
thantheworld 'spercapita consumption ofmilk. Such anevaluation based on
exaggerated assumptions would naturally result inunrealistic andimpractical standards
leading tocreation ofnon-tariff tradebarriers. Studies intheUnited States haveshown
thatalimitof0.5ppbinmilkissufficient fortheprotection ofpublic health. This
mayalsobeperhaps thelowest levelwhich canbeachieved practically. Further, as
milkfromanimals consuming aflatoxin contaminated feeds maycontain aflatoxin M1,
itwould bemore appropriate tofirstdevelop acodeofpractice regarding aflatoxin
infeedstuffs. Detailed studies needtobecarried outregarding theamount ofM1which
willbeexcreted against thecontrolled doseofingested B1.Itisonlybased onthe
results ofsuchstudies thatthemaximum limitofM1inmilkandmilkproducts should
bedecided.
8. Inconclusion, India would liketoreiterate thatinitsviewtheproposed maximum levels for
aflatoxin areunjustifiably lowandthatintroduction ofsuchrigorous import requirements, without
acorollary increase inconsumer protection, would leadtosignificant trade disruption. Wetherefore
urgetheCommission toreview itsproposed amendment ofregulation No.194/97 of31January 1997,
which hasbeennotified inWTO document G/SPS/N/EEC/51 dated 8January 1998.
__________