RESTRICTED
WORLD TRADE G/SPS/W/37
15November 1995
ORGANIZATION(95-3552)
Original: English Committee onSanitary andPhytosanitary Measures
SELECTED WORLD HEALTH ORGANIZATION ACTIVITIES
RELEVANT TOTHE IMPLEMENTATION OFTHE WTO AGREEMENT
ONTHE APPLICATION OFSANITARY AND PHYTOSANITARY MEASURES
Information document submitted byWHO
tothemeeting of15-16 November 1995
I. INTRODUCTION
1. Food, oneoftheessential requisites forhuman life,mayposearisktohealth, ifitsnutritional
value andsafety arenotadequate forconsumer protection. Therefore, governments, andinparticular,
thehealth sector, carry aprime responsibility tominimise thisrisk. Inlinewiththeefforts undertaken
bynational governments, WHO, sinceitsestablishment, hasbeengiven amandate to“develop, establish
andpromoteinternationalstandardswithrespecttofood...”1Ensuringthatfoodsproducedandprocessed
forexportation comply withfoodsafety standards andcodes ofhygienic practice constitutes oneof
thenecessary conditions fortheprotection ofthehealth ofconsumers andforthefacilitation of
international trade.
2. Under theJoint FAO/WHO Food Standards Programme, WHO hasbeenoneoftheparent
Organizations oftheCodex Alimentarius Commission (CAC) since itsestablishment in1962. Asthe
international agency dealing withhealth, WHO bears mainresponsibility forhealth andsafety aspects
ofCodex standards, guidelines andrecommendations sothattheyappropriately protect thehealth of
consumers. TheCAC hasestablished more than200foodcommodity standards andmore thanforty
hygienicandtechnologicalpracticecodes,andsetmorethan3200maximumresiduelimitsforpesticides.
3. Over theyears, WHO, inconjunction withFAO(andIAEA), hasalsobeenconvened aseries
ofmeetings ofthree scientific advisory bodies onfoodadditives, onpesticide residues andonfood
irradiation, known astheJointFAO/WHO Expert Committee onFood Additives (JECFA), theJoint
FAO/WHO Meeting onPesticide Residues (JMPR) andtheJointFAO/IAEA/WHO Expert Committee
ontheWholesomeness ofIrradiated Food(JECFI), respectively. More sporadically, scientific advisory
bodies werealsoconvened toaddress biological aspects offoodsafety aswellasother issues. Although
these bodies arenotpartoftheCAC, theyhave continuously provided scientific advice forthe
consideration bytheCodex Committee onFood Additives andContaminants (CCFAC), theCodex
Committee onPesticide Residues (CCPR), theCodex Committee onResidues ofVeterinary Drugs
inFoods (CCRVDF) andother Codex Committees, thusproviding theCAC withthescientific basis
ofitsdecision-making.
4. Theneedforfoodstandards thatserve asinternational benchmarks hasbecome evenmore
apparent intheprocess oftheUruguay Round ofMultilateral Trade Negotiations. TheRound was
concluded inMarrakesh inApril 1994bysigning oftheFinal Actcomprising anumber ofMultilateral
1Constitution oftheWorld Health Organization, Article 2(u), 1946G/SPS/W/37
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Agreements onTrade inGoods. Among them istheAgreement ontheApplication ofSanitary and
Phytosanitary Measures, inviewofwhich theDirector-General ofWHO issued aCircular Letter to
theMinisters ofHealth ofMember States thatyearcalling forincreased participation ofthenational
health sectors inthework oftheCAC concerning foodsafety andthestrengthening ofnational food
control systems2.TheAgreement, guaranteeing WTO Members theright tosettheirownlevel of
sanitary andphytosanitary protection andtoapply necessary measures, requires thatthese measures
bebased onscientific principles andoninternational standards, guidelines andrecommendations, where
theyexist. Inrelation tofoodsafety, theAgreement specifically refers tothestandards andother texts
established bytheCAC.
5. Since July1995, WHO, inaddition toitsrepresentation ontheSecretariat oftheCAC, has
beengiven thestatus ofobserver intheWTO Committee onSanitary andPhytosanitary Measures and
intends tostrengthen collaboration intheareaoffoodsafety withWTO andnational governments which
areexpected tocomply withtheSPSAgreement.
II. INTERNATIONAL NORM SETTING REGARDING ACCEPTABLE RISK INFOOD
6. Regulatory control ofchemicals infood, including foodadditives, contaminants andresidues
ofpesticides andveterinary drugs, should constitute oneoftheessential components offoodcontrol
systems ofanycountry. However, notallcountries intheworld havethecapacities orresources to
carry outthetaskoftoxicologically evaluating those chemicals. JECFA andJMPR serve tofillthis
gapandtopromoteinternationalharmonizationofassessmentmethods.Toensurescientificimpartiality,
themembers ofJECFA orJMPR arerecognised scientists whoserve intheirindividual capacity as
experts andnotasrepresentatives oftheirgovernments oremployers.
JECFA
7. JECFA wasfirstconvened byFAO andWHO in1956, inorder toelaborate specifications
fortheidentity andpurity ofindividual foodadditives thathavebeentoxicologically tested andare
incommerce andtoevaluate thetoxicological dataonthese foodadditives andestimate acceptable
human intakes. Thescope oftheevaluations werelaterextended toalsocover contaminants andresidues
ofveterinary drugs infood. During eachmeeting, theJECFA members invited byWHO areprimarily
responsible forreviewing thetoxicological andrelated dataandforestablishing, where possible,
acceptable daily intakes (ADIs) orother endpoints ofassessment andforestablishing principles for
toxicological evaluation andtesting. Ontheother hand, themembers invited byFAO areprimarily
responsible forpreparing andreviewing thespecifications foridentity andpurity offoodadditives and
forestimating maximum residues limits (MRLs) infoods ofveterinary drugs when theyareusedin
accordance withgood practice intheuseofveterinary drugs.
8. JECFA hassofarestablished ADIs andother endpoints forover700additives, contaminants
andveterinary drugresidues infood. Thereports ofmeetings havebeen published intheWHO
Technical Report Series (TRS). Thesafety dataandliterature references onthechemicals reviewed
byJECFA arepublished astoxicological monographs intheWHO Food Additive Series (FAS).
JMPR
9. JMPR wasconvened forthefirsttimein1963, inorder toevaluate thetoxicological andother
pertinent dataonthose pesticides known toleave residues infood. Itcomprises twoseparate groups
ofscientists, i.e.theWHO Expert Group onPesticide Residues (WHO Expert Group) andtheFAO
2C.L.8.1994, WHOG/SPS/W/37
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Panel ofExperts onPesticide Residues inFood andtheEnvironment (FAO Panel ofExperts). The
WHO Expert Group hasresponsibility forreviewing toxicological andrelated dataandforestablishing,
where possible, anADIforhumans, while theFAO Panel ofExperts hasresponsibility forreviewing
pesticide usepatterns, dataonthechemistry andcomposition ofpesticides, andmethods ofanalysis
ofpesticide residues, andforrecommending MRLs thatmight occur infoodcommodities following
theuseofpesticides according toGood Agricultural Practices.
10. Theprimary endpoints ofassessment ofJMPR areADIs andMRLs. JMPR hasevaluated
more than200compounds, mostofwhich havebeenvisited several times assuchorinterms ofspecific
pesticide/food combinations. Detailed evaluations ofthetoxicological andothersafety dataareavailable
asmonographs published byWHO.
IPCS
11. Since 1980, theWHO activities concerned withthesafety assessment offoodchemicals has
beenincorporated intotheInternational Programme onChemical Safety (IPCS). IPCS isacollaborative
activity oftheInternational Labour Organisation (ILO), United Nations Environment Programme
(UNEP), andtheWorld Health Organization (WHO). Anetwork of76Participating Institutions, which
playaroleinrelation tospecific tasks within IPCS, isoperational in32countries. Theactivity of
IPCSincludesadministeringtheWHOExpertGrouponPesticideResiduesandtheWHOpartofJECFA.
12. IPCS provides comprehensive riskassessment ofchemicals, including industrial chemicals,
pesticides andnatural toxins, theresult ofwhich hasbeenpublished asEnvironmental Health Criteria
series. More practical information isprovided intheHealth andSafety Guides andtheInternational
Chemical Safety Cards.
13. IPCS isactively involved withdeveloping methodology forriskassessment. Current activities
include thepreparation ofmonographs onprinciples forassessing health risks from exposure to
chemicals, principles forevaluating health riskstohuman reproduction associated withexposure to
chemicals, andprinciples forevaluating chemical effects ontheaging process. Collaborative studies
areinprogress onapplication ofshort-term testsforgenotoxicity, carcinogenicity, neurotoxicity, and
immunotoxicity.
14. Aproject hasalsobeeninitiated ontheharmonization ofapproaches totheassessment ofrisk
fromexposure tochemicals. Theobjective ofthisproject istoharmonise approaches toriskassessment
through global understanding ofhowcountries viewspecific issues andtostrive foragreement onbasic
principles. Theproject willconsider effects ofconcern, critical effects usedinsetting limits, dose-
response relationships, testmethods, datainterpretation, extrapolation, models anduncertainty factors.
IARC
15. TheInternational Agency forResearch onCancer (IARC) wasestablished byWHO in1965
inorder tomeettheneedforaninternationally coordinated attack oncancer. IARC hasbeenconducting
bothepidemiological andlaboratory research designed toidentify thecauses ofcancer, including
chemicals, toxins andmetals infood. Bothbiological andepidemiological datarelevant tocarcinogenic
agentsarereviewedbyaworkinggroupofexpertsandpublishedinIARCMonographsontheEvaluation
ofCarcinogenic Risks toHumans.
GEMS/Food
16. Food maybecome contaminated byenvironmental pollutants andother harmful substances
which cannot bedetected byconsumers. Consequently, allgovernments should establish effective
health-oriented population-based monitoring programmes. Toassist Member States inthiseffort, WHOG/SPS/W/37
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hasprovided technical advice, training andother support services toagrowing network ofGEMS/Food
participatinginstitutionswhicharelocatedinoversixtycountriesworldwide.TheGlobalEnvironmental
Monitoring System -Food Contamination Monitoring andAssessment Programme (GEMS/Food),
which hasbeenimplemented byWHO since1976, collects dataonfoodcontamination andperiodically
prepares documents onriskcharacterisation andother assessments ofhuman exposure.
17. Thecontaminants chosen formonitoring include industrial pollutants, suchastoxic metals,
pesticides andnaturally occurring toxicants. GEMS/Food hasinformed governments, theCAC and
other relevant institutions aswellasthepublic onlevels andtrends ofcontaminants infood, their
contribution tothetotalhuman exposure andsignificance withregard topublic health andtrade.
GEMS/Food alsoperforms thecalculations oftheTheoretical Maximum Daily Intake (TMDI) and
other pesticide exposure estimates fortheusebyCCPR. Aspartofitsexposure assessment work,
GEMS/Food maintains adatabase offoodconsumption based ona“global ”dietandfive“cultural ”
diets.
JECFI
18. WHO hasalsobeenconcerned about thesafety ofirradiated foods. Thetechnology can,if
properly used, beaneffective tooltofightagainst foodborne diseases andfoodlosses. Tothisend,
JECFI wasconvened forthefirsttimein1964toconsider thetechnical basisforlegislation onirradiated
food. JECFI hassubsequently reviewed anumber oftoxicological andother studies andconcluded
thattheirradiation offoods uptoanoverall doseof10kGyissafeandintroduces nospecial nutritional
ormicrobiological problems. These results ledtotheadoption in1983bytheCACoftheCodex General
Standard forIrradiated Foods.
19. In1984, theJoint FAO/IAEA/WHO International Consultative Group onFood Irradiation
(ICGFI) wasestablished toevaluate global developments inthefieldoffoodirradiation andtoprovide
information, asrequired, toJECFI andtheCAC. Theactivity ofICGFI, agroup ofgovernment-
designated experts, issupported bytheOrganizations and44Member Countries.
Biological Hazards
20. Inaddition tochemical hazards, biological hazards haveapotential toposemajor health risks
when ingesting foods. Theinclusion ofmicrobiological criteria inCodex standards hasgenerally been
guided bythePrinciples fortheEstablishment andApplication ofMicrobiological Criteria forFoods,
which iscurrently under review forupdating.
21. More specifically, cholera, anotifiable disease under theInternational Health Regulations (IHR)
ofWHO, isknown asoneoftheinfectious diseases whose outbreaks often results inadramatic fall
inthecountry ’sfoodexport. In1992, upontheissueoftheWHO guidance onFormulation ofNational
Policy ontheControl ofCholera, theDirector-General ofWHO drew attention ofMember States to
thefactthattheriskoftransmission ofcholera from infected countries through theexport offood
commoditiesproducedunderGoodManufacturingPracticeisminimal,andthatconsequentlytheplacing
ofembargoes ontheimportation ofsuchfoodisnotanappropriate course ofaction toprevent the
international spread ofthedisease3.
22. Guidelines forCholera Control, alsoprepared byWHO, provide information onhowtocontrol
andprevent itsspread. Itstresses theimportance offoodsafety, safewater supply andpersonal hygiene
fortheprevention ofcholera. Theguidelines areintended primarily forusebymanagers ofnational
programmes forcholera control, from thelocaltotheinternational level.
3C.L.17.1992, WHOG/SPS/W/37
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23. Withregard tothetheoretical riskoftransmission ofbovine spongiform encephalopathy (BSE)
tohumans, WHO initiated aconsultation process andissued recommendations toprotect public health.
Radioactive Hazards
24. Following theChernobyl accident in1986, WHO initiated aninternational consultation process,
attheendofwhich thederived intervention levels forradionuclides infoodweredeveloped. These
intervention levels formed thebasisforthedecision oftheCAC toadopt, in1989, theGuideline Levels
forRadionuclidesinFoodsFollowingAccidentalNuclearContaminationforUseinInternationalTrade4.
Safety Assessment ofBiotechnology
25. WHO hasbeen concerned withthehealth aspect ofnewtechnologies introduced infood
production andfoodprocessing. TheWorkshop onHealth Aspects ofMarker Genes inGenetically
Modified Plants (Copenhagen, September 1993) andtheWorkshop ontheApplication ofthePrinciples
ofSubstantial Equivalence totheSafety Evaluation ofFoods orFood Components fromPlants Derived
byModern Biotechnology (Copenhagen, November 1994) wereheldascontinuation ofthework on
assessing thesafety offoods produced bybiotechnology which wasstarted in1990, jointly withFAO.
Theoutcome oftheabove-mentioned consultation andworkshops willconstitute abasisfortheplanned
development ofCodex Guidelines fortheEvaluation ofFoods Produced byBiotechnology.
HACCP
26. WHO hasbeenpromoting theintegration ofHazard Analysis Critical Control Point (HACCP)
System infoodcontrol systems. InMarch 1993, WHO convened aconsultation onHACCP training
todevelop aconsensus approach intheapplication ofHACCP tofoodprocessing andmanufacturing.
Another WHO consultation onHACCP wasconvened withtheparticipation ofFAO inMay1995 to
review theconcept andapplication ofHACCP andpropose improvements totheCodex Guidelines,
which hadbeenadopted byCAC in1993. Therecommendations oftheConsultation, including a
proposal fortherevision oftheCodex Guidelines fortheApplication ofHACCP, areexpected tobe
discussed intheforthcoming session oftheCodex Committee onFood Hygiene. Inresponse tothe
recommendations, WHO alsoplans todevelop guidelines fortheauditing ofHACCP-driven industries.
RiskAnalysis
27. Attherequest oftheCodex Executive Committee, WHO organised, incollaboration withFAO,
aconsultation ontheapplication ofriskanalysis tofoodstandards issues, inMarch 1995. The
Consultation wasasignificant event intheinternational application ofriskassessment, particularly
inthecontext oftheCAC andtrade implications oftheSPSAgreement. Itcame upwithanumber
ofrecommendations fortheCAC, scientific advisory bodies, andtothenational governments. Based
ontheoutcome oftheconsultation, further FAO/WHO consultations onriskmanagement andrisk
communication areexpected tobeconvened induecourse.
28. Inaneffort toimprove thescientific basis ofCAC decision-making, ajoint FAO/WHO
Consultation washeldinMay1995 tomake recommendations fortherevision ofguidelines usedfor
predicting dietary intake ofpesticide residues. TheConsultation identified several opportunities for
improving international exposure assessments andprovided guidance toMember States inconducting
national exposure estimates.
4CAC/GL5-1989G/SPS/W/37
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III. TECHNICAL COOPERATION
29. Thecompliance withtheSPSAgreement presupposes thecountry ’scapability toappropriately
conduct riskanalysis5infoodsafety. Namely, Articles 2,3and4oftheAgreement require WTO
Members to:
(i) apply sanitary andphytosanitary measures based onscientific principles;
(ii) scientifically justify sanitary andphytosanitary measures which result inhigher levels
ofsanitary andphytosanitary protection thanwould beachieved bymeasures based
ontherelevant international standards, guidelines andrecommendations (e.g.Codex);
(iii) demonstrate, asanexporting country, theequivalence ofitssanitary andphytosanitary
measurestothoseofimportingcountriesinachievingtheimportingcountry’sappropriate
levelofsanitary andphytosanitary protection.
30. Furthermore,Article5oftheAgreementexplicitlyrequiresWTOMemberstoconductscientific
andconsistent riskassessment6.Asfoodconsumption patterns mayvaryfromonecountry toanother,
or,evenwithin acountry, itisessential foreachMember Statetobeabletoperform necessary chemical
andbiological analysis offoodsamples andtocalculate thedietary exposure leveloftheirpopulation
tofoodborne hazards.
31. Theapplication ofHACCP system inalmost every stageofthefoodchain would beoneeffective
wayforgovernments tomeettheSPSagreement. HACCP hasbeenrecognised asthepreferred risk
assessment andriskmanagement toolbyanincreasing number ofcountries aswellasbytheCAC.
Thisdemands extensive training ofbothfoodinspectors andfoodproducers aswellasthetransformation
ofthenational foodcontrol regulation from aprescriptive onetoaHACCP-based one.
32. These requirements cannot bemetunless theMember introduces anup-to-date foodlegislation
andcontrol system. Difficult asitmight beforadeveloping country, adjustment totheSPSAgreement
notonlyensures access toforeign markets, butalsoleads tobetter health protection foritspeople.
Theimproved foodsafety technologies andinfrastructure, including theestablishment ofnational
regulatory bodies andlaboratories, encourage thedevelopment ofvalue-added industries andpromotes
thecompetitive quality ofitsfood products. Inthiseffort, WHO canprovide policy guidance,
information, technical advice andtraining opportunities onallmatters related tohealth andsafety
requirements.
IV. BIBLIOGRAPHY
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