Page69
AGREEMENT ONTHE APPLICATION OF
SANITARY AND PHYTOSANITARY MEASURES
Members ,
ReaffirmingthatnoMembershouldbepreventedfromadoptingorenforcingmeasuresnecessary
toprotect human, animal orplant lifeorhealth, subject totherequirement thatthese measures are
notapplied inamanner which would constitute ameans ofarbitrary orunjustifiable discrimination
between Members where thesame conditions prevail oradisguised restriction oninternational trade;
Desiring toimprove thehuman health, animal health andphytosanitary situation inallMembers;
Noting thatsanitary andphytosanitary measures areoften applied onthebasis ofbilateral
agreements orprotocols;
Desiring theestablishment ofamultilateral framework ofrules anddisciplines toguide the
development, adoption andenforcement ofsanitary andphytosanitary measures inorder tominimize
their negative effects ontrade;
Recognizing theimportant contribution that international standards, guidelines and
recommendations canmake inthisregard;
DesiringtofurthertheuseofharmonizedsanitaryandphytosanitarymeasuresbetweenMembers,
onthebasis ofinternational standards, guidelines andrecommendations developed bytherelevant
international organizations, including theCodex Alimentarius Commission, theInternational Office
ofEpizootics, andtherelevant international andregional organizations operating within theframework
oftheInternational PlantProtection Convention, without requiring Members tochange theirappropriate
levelofprotection ofhuman, animal orplant lifeorhealth;
Recognizing thatdeveloping country Members mayencounter special difficulties incomplying
withthesanitary orphytosanitary measures ofimporting Members, andasaconsequence inaccess
tomarkets, andalsointheformulation andapplication ofsanitary orphytosanitary measures intheir
ownterritories, anddesiring toassist them intheirendeavours inthisregard;
Desiring therefore toelaborate rulesfortheapplication oftheprovisions ofGATT 1994which
relate totheuseofsanitary orphytosanitary measures, inparticular theprovisions ofArticle XX(b)1;
Hereby agree asfollows:
1InthisAgreement, reference toArticle XX(b) includes alsothechapeau ofthatArticle.Page70
Article 1
General Provisions
1. ThisAgreement applies toallsanitary andphytosanitary measures which may, directly or
indirectly, affect international trade. Suchmeasures shallbedeveloped andapplied inaccordance with
theprovisions ofthisAgreement.
2. Forthepurposes ofthisAgreement, thedefinitions provided inAnnex Ashallapply.
3. Theannexes areanintegral partofthisAgreement.
4. Nothing inthisAgreement shallaffect therights ofMembers under theAgreement onTechnical
Barriers toTrade withrespect tomeasures notwithin thescope ofthisAgreement.
Article 2
Basic Rights andObligations
1. Members havetherighttotakesanitary andphytosanitary measures necessary fortheprotection
ofhuman, animal orplant lifeorhealth, provided thatsuchmeasures arenotinconsistent withthe
provisions ofthisAgreement.
2. Members shallensure thatanysanitary orphytosanitary measure isapplied onlytotheextent
necessary toprotect human, animal orplant lifeorhealth, isbased onscientific principles andisnot
maintained without sufficient scientific evidence, except asprovided forinparagraph 7ofArticle 5.
3. Members shall ensure thattheirsanitary andphytosanitary measures donotarbitrarily or
unjustifiably discriminate between Members where identical orsimilar conditions prevail, including
between theirownterritory andthatofother Members. Sanitary andphytosanitary measures shall
notbeapplied inamanner which would constitute adisguised restriction oninternational trade.
4. Sanitary orphytosanitary measures which conform totherelevant provisions ofthisAgreement
shallbepresumed tobeinaccordance withtheobligations oftheMembers under theprovisions of
GATT 1994which relate totheuseofsanitary orphytosanitary measures, inparticular theprovisions
ofArticle XX(b).
Article 3
Harmonization
1. Toharmonize sanitary andphytosanitary measures onaswideabasis aspossible, Members
shall base their sanitary orphytosanitary measures oninternational standards, guidelines or
recommendations,wheretheyexist,exceptasotherwiseprovidedforinthisAgreement,andinparticular
inparagraph 3.Page71
2. Sanitary orphytosanitary measures which conform tointernational standards, guidelines or
recommendations shallbedeemed tobenecessary toprotect human, animal orplant lifeorhealth,
andpresumed tobeconsistent withtherelevant provisions ofthisAgreement andofGATT 1994.
3. Members mayintroduce ormaintain sanitary orphytosanitary measures which result inahigher
levelofsanitary orphytosanitary protection thanwould beachieved bymeasures based ontherelevant
international standards, guidelines orrecommendations, ifthere isascientific justification, orasa
consequence ofthelevelofsanitary orphytosanitary protection aMember determines tobeappropriate
inaccordance withtherelevant provisions ofparagraphs 1through 8ofArticle 5.2Notwithstanding
theabove, allmeasures which result inalevelofsanitary orphytosanitary protection different from
thatwhich would beachieved bymeasures based oninternational standards, guidelines or
recommendations shallnotbeinconsistent withanyother provision ofthisAgreement.
4. Members shallplayafullpart,within thelimits oftheirresources, intherelevant international
organizations andtheir subsidiary bodies, inparticular theCodex Alimentarius Commission, the
International Office ofEpizootics, andtheinternational andregional organizations operating within
theframework oftheInternational Plant Protection Convention, topromote within these organizations
thedevelopment andperiodic review ofstandards, guidelines andrecommendations withrespect to
allaspects ofsanitary andphytosanitary measures.
5. TheCommittee onSanitary andPhytosanitary Measures provided forinparagraphs 1and4
ofArticle 12(referred tointhisAgreement asthe"Committee") shalldevelop aprocedure tomonitor
theprocess ofinternational harmonization andcoordinate efforts inthisregard withtherelevant
international organizations.
Article 4
Equivalence
1. Members shallaccept thesanitary orphytosanitary measures ofother Members asequivalent,
evenifthesemeasures differ fromtheirownorfromthose usedbyother Members trading inthesame
product, iftheexporting Member objectively demonstrates totheimporting Member thatitsmeasures
achieve theimporting Member 'sappropriate levelofsanitary orphytosanitary protection. Forthis
purpose, reasonable access shallbegiven, uponrequest, totheimporting Member forinspection, testing
andother relevant procedures.
2. Members shall, upon request, enter intoconsultations withtheaimofachieving bilateral and
multilateralagreementsonrecognitionoftheequivalenceofspecifiedsanitaryorphytosanitarymeasures.
2Forthepurposes ofparagraph 3ofArticle 3,there isascientific justification if,onthebasis ofanexamination and
evaluationofavailablescientificinformationinconformitywiththerelevantprovisionsofthisAgreement,aMemberdetermines
thattherelevant international standards, guidelines orrecommendations arenotsufficient toachieve itsappropriate level
ofsanitary orphytosanitary protection.Page72
Article 5
Assessment ofRiskandDetermination oftheAppropriate Level
ofSanitary orPhytosanitary Protection
1. Members shallensure thattheirsanitary orphytosanitary measures arebased onanassessment,
asappropriate tothecircumstances, oftheriskstohuman, animal orplant lifeorhealth, taking into
account riskassessment techniques developed bytherelevant international organizations.
2. Intheassessmentofrisks,Membersshalltakeintoaccountavailablescientificevidence;relevant
processes andproduction methods; relevant inspection, sampling andtesting methods; prevalence
ofspecific diseases orpests; existence ofpest- ordisease-free areas; relevant ecological and
environmental conditions; andquarantine orother treatment.
3. Inassessing therisktoanimal orplantlifeorhealth anddetermining themeasure tobeapplied
forachieving theappropriate levelofsanitary orphytosanitary protection from suchrisk,Members
shalltakeintoaccount asrelevant economic factors: thepotential damage interms oflossofproduction
orsales intheevent oftheentry, establishment orspread ofapestordisease; thecosts ofcontrol
oreradication intheterritory oftheimporting Member; andtherelative cost-effectiveness ofalternative
approaches tolimiting risks.
4. Membersshould,whendeterminingtheappropriatelevelofsanitaryorphytosanitaryprotection,
takeintoaccount theobjective ofminimizing negative trade effects.
5. With theobjective ofachieving consistency intheapplication oftheconcept ofappropriate
level ofsanitary orphytosanitary protection against risks tohuman lifeorhealth, ortoanimal and
plant lifeorhealth, eachMember shallavoid arbitrary orunjustifiable distinctions inthelevels it
considers tobeappropriate indifferent situations, ifsuchdistinctions result indiscrimination ora
disguised restriction oninternational trade. Members shallcooperate intheCommittee, inaccordance
withparagraphs 1,2and3ofArticle 12,todevelop guidelines tofurther thepractical implementation
ofthisprovision. Indeveloping theguidelines, theCommittee shalltakeintoaccount allrelevant factors,
including theexceptional character ofhuman health riskstowhich people voluntarily expose themselves.
6. Without prejudice toparagraph 2ofArticle 3,when establishing ormaintaining sanitary or
phytosanitarymeasurestoachievetheappropriatelevelofsanitaryorphytosanitaryprotection,Members
shallensure thatsuchmeasures arenotmore trade-restrictive thanrequired toachieve theirappropriate
levelofsanitary orphytosanitary protection, taking intoaccount technical andeconomic feasibility.3
7. Incases where relevant scientific evidence isinsufficient, aMember mayprovisionally adopt
sanitary orphytosanitary measures onthebasisofavailable pertinent information, including thatfrom
therelevant international organizations aswellasfromsanitary orphytosanitary measures applied by
other Members. Insuchcircumstances, Members shall seektoobtain theadditional information
necessary foramore objective assessment ofriskandreview thesanitary orphytosanitary measure
accordingly within areasonable period oftime.
3Forpurposes ofparagraph 6ofArticle 5,ameasure isnotmore trade-restrictive thanrequired unless there isanother
measure, reasonably available taking intoaccount technical andeconomic feasibility, thatachieves theappropriate level of
sanitary orphytosanitary protection andissignificantly lessrestrictive totrade.Page73
8. WhenaMemberhasreasontobelievethataspecificsanitaryorphytosanitarymeasureintroduced
ormaintained byanother Member isconstraining, orhasthepotential toconstrain, itsexports and
themeasure isnotbased ontherelevant international standards, guidelines orrecommendations, or
suchstandards, guidelines orrecommendations donotexist, anexplanation ofthereasons forsuch
sanitary orphytosanitary measure mayberequested andshallbeprovided bytheMember maintaining
themeasure.
Article 6
Adaptation toRegional Conditions, Including Pest- orDisease-Free Areas
andAreas ofLowPestorDisease Prevalence
1. Members shallensure thattheirsanitary orphytosanitary measures areadapted tothesanitary
orphytosanitary characteristics ofthearea-whether allofacountry, partofacountry, orallorparts
ofseveral countries -from which theproduct originated andtowhich theproduct isdestined. In
assessing thesanitary orphytosanitary characteristics ofaregion, Members shalltakeintoaccount,
interalia,thelevelofprevalence ofspecific diseases orpests, theexistence oferadication orcontrol
programmes, andappropriate criteria orguidelines which maybedeveloped bytherelevant international
organizations.
2. Members shall, inparticular, recognize theconcepts ofpest-ordisease-free areas andareas
oflowpestordisease prevalence. Determination ofsuchareas shall bebased onfactors suchas
geography, ecosystems, epidemiological surveillance, andtheeffectiveness ofsanitary orphytosanitary
controls.
3. Exporting Members claiming thatareas within theirterritories arepest-ordisease-free areas
orareas oflowpestordisease prevalence shallprovide thenecessary evidence thereof inorder to
objectively demonstrate totheimporting Member thatsuchareas are,andarelikely toremain, pest-
ordisease-free areas orareas oflowpestordisease prevalence, respectively. Forthispurpose,
reasonable access shallbegiven, upon request, totheimporting Member forinspection, testing and
other relevant procedures.
Article 7
Transparency
Members shallnotify changes intheirsanitary orphytosanitary measures andshallprovide
information ontheirsanitary orphytosanitary measures inaccordance withtheprovisions ofAnnex B.
Article 8
Control, Inspection andApproval Procedures
Members shallobserve theprovisions ofAnnex Cintheoperation ofcontrol, inspection and
approval procedures, including national systems forapproving theuseofadditives orforestablishing
tolerances forcontaminants infoods, beverages orfeedstuffs, andotherwise ensure thattheirprocedures
arenotinconsistent withtheprovisions ofthisAgreement.Page74
Article 9
Technical Assistance
1. Members agree tofacilitate theprovision oftechnical assistance toother Members, especially
developing country Members, either bilaterally orthrough theappropriate international organizations.
Suchassistance maybe,interalia,intheareas ofprocessing technologies, research andinfrastructure,
including intheestablishment ofnational regulatory bodies, andmaytaketheformofadvice, credits,
donations andgrants, including forthepurpose ofseeking technical expertise, training andequipment
toallow suchcountries toadjust to,andcomply with, sanitary orphytosanitary measures necessary
toachieve theappropriate levelofsanitary orphytosanitary protection intheirexport markets.
2. WheresubstantialinvestmentsarerequiredinorderforanexportingdevelopingcountryMember
tofulfil thesanitary orphytosanitary requirements ofanimporting Member, thelatter shallconsider
providingsuchtechnicalassistanceaswillpermitthedevelopingcountryMembertomaintainandexpand
itsmarket access opportunities fortheproduct involved.
Article 10
Special andDifferential Treatment
1. Inthepreparation andapplication ofsanitary orphytosanitary measures, Members shalltake
account ofthespecial needs ofdeveloping country Members, andinparticular oftheleast-developed
country Members.
2. Where theappropriate levelofsanitary orphytosanitary protection allows scope forthephased
introduction ofnewsanitary orphytosanitary measures, longer time-frames forcompliance should be
accorded onproducts ofinterest todeveloping country Members soastomaintain opportunities for
theirexports.
3. WithaviewtoensuringthatdevelopingcountryMembersareabletocomplywiththeprovisions
ofthisAgreement, theCommittee isenabled togrant tosuchcountries, uponrequest, specified, time-
limited exceptions inwhole orinpartfromobligations under thisAgreement, taking intoaccount their
financial, trade anddevelopment needs.
4. MembersshouldencourageandfacilitatetheactiveparticipationofdevelopingcountryMembers
intherelevant international organizations.
Article 11
Consultations andDispute Settlement
1. Theprovisions ofArticles XXII andXXIII ofGATT 1994 aselaborated andapplied bythe
Dispute Settlement Understanding shallapply toconsultations andthesettlement ofdisputes under
thisAgreement, except asotherwise specifically provided herein.Page75
2. Inadispute under thisAgreement involving scientific ortechnical issues, apanel should seek
advice from experts chosen bythepanel inconsultation withtheparties tothedispute. Tothisend,
thepanel may, when itdeems itappropriate, establish anadvisory technical experts group, orconsult
therelevant international organizations, attherequest ofeither party tothedispute oronitsown
initiative.
3. Nothing inthisAgreement shall impair therights ofMembers under other international
agreements, including therighttoresort tothegoodoffices ordispute settlement mechanisms ofother
international organizations orestablished under anyinternational agreement.
Article 12
Administration
1. ACommittee onSanitary andPhytosanitary Measures ishereby established toprovide aregular
forum forconsultations. Itshallcarry outthefunctions necessary toimplement theprovisions ofthis
Agreement andthefurtherance ofitsobjectives, inparticular withrespect toharmonization. The
Committee shallreach itsdecisions byconsensus.
2. TheCommittee shall encourage andfacilitate adhocconsultations ornegotiations among
Members onspecific sanitary orphytosanitary issues. TheCommittee shallencourage theuseof
international standards, guidelines orrecommendations byallMembers and,inthisregard, shallsponsor
technical consultation andstudy withtheobjective ofincreasing coordination andintegration between
international andnational systems andapproaches forapproving theuseoffoodadditives orfor
establishing tolerances forcontaminants infoods, beverages orfeedstuffs.
3. TheCommittee shallmaintain close contact withtherelevant international organizations in
thefieldofsanitary andphytosanitary protection, especially withtheCodex Alimentarius Commission,
theInternationalOfficeofEpizootics,andtheSecretariatoftheInternationalPlantProtectionConvention,
withtheobjective ofsecuring thebestavailable scientific andtechnical advice fortheadministration
ofthisAgreement andinorder toensure thatunnecessary duplication ofeffort isavoided.
4. TheCommittee shalldevelop aprocedure tomonitor theprocess ofinternational harmonization
andtheuseofinternational standards, guidelines orrecommendations. Forthispurpose, theCommittee
should, inconjunction withtherelevant international organizations, establish alistofinternational
standards, guidelines orrecommendations relating tosanitary orphytosanitary measures which the
Committee determines tohaveamajor tradeimpact. Thelistshould include anindication byMembers
ofthose international standards, guidelines orrecommendations which theyapply asconditions for
import oronthebasis ofwhich imported products conforming tothese standards canenjoy access
totheirmarkets. Forthose cases inwhich aMember doesnotapply aninternational standard, guideline
orrecommendation asacondition forimport, theMember should provide anindication ofthereason
therefor, and,inparticular, whether itconsiders thatthestandard isnotstringent enough toprovide
theappropriate levelofsanitary orphytosanitary protection. IfaMember revises itsposition, following
itsindication oftheuseofastandard, guideline orrecommendation asacondition forimport, itshould
provide anexplanation foritschange andsoinform theSecretariat aswellastherelevant international
organizations, unless suchnotification andexplanation isgiven according totheprocedures ofAnnex B.Page76
5. Inorder toavoid unnecessary duplication, theCommittee maydecide, asappropriate, touse
theinformation generated bytheprocedures, particularly fornotification, which areinoperation in
therelevant international organizations.
6. TheCommittee may,onthebasisofaninitiative fromoneoftheMembers, through appropriate
channels invite therelevant international organizations ortheirsubsidiary bodies toexamine specific
matters withrespect toaparticular standard, guideline orrecommendation, including thebasis of
explanations fornon-use given according toparagraph 4.
7. TheCommittee shallreview theoperation andimplementation ofthisAgreement threeyears
afterthedateofentry intoforce oftheWTO Agreement, andthereafter astheneedarises. Where
appropriate, theCommittee maysubmit totheCouncil forTrade inGoods proposals toamend the
textofthisAgreement having regard, interalia,totheexperience gained initsimplementation.
Article 13
Implementation
Members arefullyresponsible under thisAgreement fortheobservance ofallobligations set
forthherein. Members shallformulate andimplement positive measures andmechanisms insupport
oftheobservanceoftheprovisionsofthisAgreementbyotherthancentralgovernmentbodies.Members
shalltakesuchreasonable measures asmaybeavailable tothemtoensure thatnon-governmental entities
within theirterritories, aswellasregional bodies inwhich relevant entities within theirterritories are
members, comply withtherelevant provisions ofthisAgreement. Inaddition, Members shallnot
takemeasures which havetheeffect of,directly orindirectly, requiring orencouraging suchregional
ornon-governmental entities, orlocalgovernmental bodies, toactinamanner inconsistent withthe
provisions ofthisAgreement. Members shallensure thattheyrelyontheservices ofnon-governmental
entities forimplementing sanitary orphytosanitary measures onlyifthese entities comply withthe
provisions ofthisAgreement.
Article 14
Final Provisions
Theleast-developedcountryMembersmaydelayapplicationoftheprovisionsofthisAgreement
foraperiod offiveyears following thedateofentry intoforce oftheWTO Agreement withrespect
totheirsanitary orphytosanitary measures affecting importation orimported products. Other developing
country Members maydelay application oftheprovisions ofthisAgreement, other thanparagraph 8
ofArticle 5andArticle 7,fortwoyears following thedateofentry intoforce oftheWTO Agreement
withrespect totheirexisting sanitary orphytosanitary measures affecting importation orimported
products, where suchapplication isprevented byalackoftechnical expertise, technical infrastructure
orresources.Page77
ANNEX A
DEFINITIONS4
1. Sanitary orphytosanitary measure -Anymeasure applied:
(a) toprotect animal orplantlifeorhealth within theterritory oftheMember fromrisks
arising from theentry, establishment orspread ofpests, diseases, disease-carrying
organisms ordisease-causing organisms;
(b) toprotect human oranimal lifeorhealth within theterritory oftheMember fromrisks
arising from additives, contaminants, toxins ordisease-causing organisms infoods,
beverages orfeedstuffs;
(c) toprotect human lifeorhealth within theterritory oftheMember fromrisksarising
from diseases carried byanimals, plants orproducts thereof, orfrom theentry,
establishment orspread ofpests; or
(d) toprevent orlimitother damage within theterritory oftheMember fromtheentry,
establishment orspread ofpests.
Sanitary orphytosanitary measures include allrelevant laws, decrees, regulations, requirements and
procedures including, interalia,endproduct criteria; processes andproduction methods; testing,
inspection, certification andapproval procedures; quarantine treatments including relevant requirements
associated withthetransport ofanimals orplants, orwiththematerials necessary fortheirsurvival
during transport; provisions onrelevant statistical methods, sampling procedures andmethods ofrisk
assessment; andpackaging andlabelling requirements directly related tofoodsafety.
2. Harmonization -Theestablishment, recognition andapplication ofcommon sanitary and
phytosanitary measures bydifferent Members.
3. International standards, guidelines andrecommendations
(a) forfoodsafety,thestandards,guidelinesandrecommendationsestablishedbytheCodex
Alimentarius Commission relating tofoodadditives, veterinary drugandpesticide
residues, contaminants, methods ofanalysis andsampling, andcodes andguidelines
ofhygienic practice;
(b) foranimal health andzoonoses, thestandards, guidelines andrecommendations
developed under theauspices oftheInternational Office ofEpizootics;
(c) forplanthealth, theinternational standards, guidelines andrecommendations developed
under theauspices oftheSecretariat oftheInternational Plant Protection Convention
incooperation withregional organizations operating within theframework ofthe
International Plant Protection Convention; and
4Forthepurpose ofthese definitions, "animal" includes fishandwildfauna; "plant" includes forests andwildflora;
"pests" include weeds; and"contaminants" include pesticide andveterinary drug residues andextraneous matter.Page78
(d) formatters notcovered bytheabove organizations, appropriate standards, guidelines
andrecommendations promulgated byother relevant international organizations open
formembership toallMembers, asidentified bytheCommittee.
4. Riskassessment -Theevaluation ofthelikelihood ofentry, establishment orspread ofapest
ordisease within theterritory ofanimporting Member according tothesanitary orphytosanitary
measures which might beapplied, andoftheassociated potential biological andeconomic consequences;
ortheevaluation ofthepotential foradverse effects onhuman oranimal health arising fromthepresence
ofadditives, contaminants, toxins ordisease-causing organisms infood, beverages orfeedstuffs.
5. Appropriate levelofsanitary orphytosanitary protection -Thelevel ofprotection deemed
appropriate bytheMember establishing asanitary orphytosanitary measure toprotect human, animal
orplant lifeorhealth within itsterritory.
NOTE: Many Members otherwise refertothisconcept asthe"acceptable levelofrisk".
6. Pest- ordisease-free area-Anarea,whether allofacountry, partofacountry, orallorparts
ofseveral countries, asidentified bythecompetent authorities, inwhich aspecific pestordisease does
notoccur.
NOTE: Apest-ordisease-free areamaysurround, besurrounded by,orbeadjacent toanarea-whether
within partofacountry orinageographic region which includes partsoforallofseveral countries -
inwhich aspecific pestordisease isknown tooccur butissubject toregional control measures such
astheestablishment ofprotection, surveillance andbuffer zones which willconfine oreradicate the
pestordisease inquestion.
7. Areaoflowpestordisease prevalence -Anarea, whether allofacountry, partofacountry,
orallorpartsofseveral countries, asidentified bythecompetent authorities, inwhich aspecific pest
ordisease occurs atlowlevels andwhich issubject toeffective surveillance, control oreradication
measures.Page79
ANNEX B
TRANSPARENCY OFSANITARY AND PHYTOSANITARY REGULATIONS
Publication ofregulations
1. Members shallensure thatallsanitary andphytosanitary regulations5which havebeenadopted
arepublished promptly insuchamanner astoenable interested Members tobecome acquainted with
them.
2. Except inurgent circumstances, Members shall allow areasonable interval between the
publication ofasanitary orphytosanitary regulation anditsentry intoforce inorder toallow timefor
producersinexportingMembers,andparticularlyindevelopingcountryMembers,toadapttheirproducts
andmethods ofproduction totherequirements oftheimporting Member.
Enquiry points
3. EachMember shallensure thatoneenquiry point exists which isresponsible fortheprovision
ofanswers toallreasonable questions frominterested Members aswellasfortheprovision ofrelevant
documents regarding:
(a) anysanitary orphytosanitary regulations adopted orproposed within itsterritory;
(b) anycontrol andinspection procedures, production andquarantine treatment, pesticide
toleranceandfoodadditiveapprovalprocedures,whichareoperatedwithinitsterritory;
(c) riskassessmentprocedures,factorstakenintoconsideration,aswellasthedetermination
oftheappropriate levelofsanitary orphytosanitary protection;
(d) themembership andparticipation oftheMember, orofrelevant bodies within its
territory, ininternational andregional sanitary andphytosanitary organizations and
systems, aswellasinbilateral andmultilateral agreements andarrangements within
thescope ofthisAgreement, andthetextsofsuchagreements andarrangements.
4. Members shallensure thatwhere copies ofdocuments arerequested byinterested Members,
theyaresupplied atthesame price (ifany), apart fromthecostofdelivery, astothenationals6ofthe
Member concerned.
5Sanitary andphytosanitary measures such aslaws, decrees orordinances which areapplicable generally.
6When "nationals" arereferred tointhisAgreement, thetermshallbedeemed, inthecaseofaseparate customs territory
Member oftheWTO, tomean persons, natural orlegal, whoaredomiciled orwhohave arealandeffective industrial or
commercial establishment inthatcustoms territory.Page80
Notification procedures
5. Whenever aninternational standard, guideline orrecommendation doesnotexistorthecontent
ofaproposed sanitary orphytosanitary regulation isnotsubstantially thesame asthecontent ofan
international standard, guideline orrecommendation, andiftheregulation mayhaveasignificant effect
ontrade ofother Members, Members shall:
(a) publish anotice atanearly stage insuchamanner astoenable interested Members
tobecome acquainted withtheproposal tointroduce aparticular regulation;
(b) notify other Members, through theSecretariat, oftheproducts tobecovered bythe
regulation together withabriefindication oftheobjective andrationale oftheproposed
regulation. Such notifications shalltakeplace atanearly stage, when amendments
canstillbeintroduced andcomments taken intoaccount;
(c) provideuponrequesttootherMemberscopiesoftheproposedregulationand,whenever
possible, identify theparts which insubstance deviate from international standards,
guidelines orrecommendations;
(d) without discrimination, allow reasonable timeforother Members tomake comments
inwriting, discuss thesecomments uponrequest, andtakethecomments andtheresults
ofthediscussions intoaccount.
6. However, where urgent problems ofhealth protection ariseorthreaten toariseforaMember,
thatMember mayomitsuchofthestepsenumerated inparagraph 5ofthisAnnex asitfindsnecessary,
provided thattheMember:
(a) immediatelynotifiesotherMembers,throughtheSecretariat,oftheparticularregulation
andtheproducts covered, withabriefindication oftheobjective andtherationale of
theregulation, including thenature oftheurgent problem(s);
(b) provides, upon request, copies oftheregulation toother Members;
(c) allows other Members tomake comments inwriting, discusses these comments upon
request, andtakes thecomments andtheresults ofthediscussions intoaccount.
7. Notifications totheSecretariat shallbeinEnglish, French orSpanish.
8. Developed country Members shall, ifrequested byother Members, provide copies ofthe
documents or,incaseofvoluminous documents, summaries ofthedocuments covered byaspecific
notification inEnglish, French orSpanish.
9. TheSecretariat shallpromptly circulate copies ofthenotification toallMembers andinterested
international organizations anddrawtheattention ofdeveloping country Members toanynotifications
relating toproducts ofparticular interest tothem.
10. Members shall designate asingle central government authority asresponsible forthe
implementation, onthenational level, oftheprovisions concerning notification procedures according
toparagraphs 5,6,7and8ofthisAnnex.Page81
General reservations
11. Nothing inthisAgreement shallbeconstrued asrequiring:
(a) theprovision ofparticulars orcopies ofdrafts orthepublication oftextsother than
inthelanguage oftheMember except asstated inparagraph 8ofthisAnnex; or
(b) Members todisclose confidential information which would impede enforcement of
sanitaryorphytosanitarylegislationorwhichwouldprejudicethelegitimatecommercial
interests ofparticular enterprises.Page82
ANNEX C
CONTROL, INSPECTION AND APPROVAL PROCEDURES7
1. Members shallensure, withrespect toanyprocedure tocheck andensure thefulfilment of
sanitary orphytosanitary measures, that:
(a) suchprocedures areundertaken andcompleted without undue delay andinnoless
favourable manner forimported products thanforlikedomestic products;
(b) thestandard processing period ofeachprocedure ispublished orthattheanticipated
processing period iscommunicated totheapplicant uponrequest; when receiving an
application, thecompetent body promptly examines thecompleteness ofthe
documentation andinforms theapplicant inaprecise andcomplete manner ofall
deficiencies; thecompetent body transmits assoon aspossible theresults ofthe
procedure inaprecise andcomplete manner totheapplicant sothatcorrective action
maybetaken ifnecessary; evenwhen theapplication hasdeficiencies, thecompetent
body proceeds asfaraspracticable withtheprocedure iftheapplicant sorequests;
andthatupon request, theapplicant isinformed ofthestage oftheprocedure, with
anydelay being explained;
(c) information requirements arelimited towhat isnecessary forappropriate control,
inspection andapproval procedures, including forapproval oftheuseofadditives
orfortheestablishment oftolerances forcontaminants infood, beverages orfeedstuffs;
(d) theconfidentiality ofinformation about imported products arising from orsupplied
inconnection withcontrol, inspection andapproval isrespected inawaynoless
favourable thanfordomestic products andinsuchamanner thatlegitimate commercial
interests areprotected;
(e) anyrequirements forcontrol, inspection andapproval ofindividual specimens ofa
product arelimited towhatisreasonable andnecessary;
(f) anyfeesimposed fortheprocedures onimported products areequitable inrelation
toanyfeescharged onlikedomestic products orproducts originating inanyother
Member andshould benohigher thantheactual costoftheservice;
(g) thesame criteria should beusedinthesiting offacilities usedintheprocedures and
theselection ofsamples ofimported products asfordomestic products soastominimize
theinconvenience toapplicants, importers, exporters ortheiragents;
(h) wheneverspecificationsofaproductarechangedsubsequenttoitscontrolandinspection
inlightoftheapplicable regulations, theprocedure forthemodified product islimited
towhatisnecessary todetermine whether adequate confidence exists thattheproduct
stillmeets theregulations concerned; and
7Control, inspection andapproval procedures include, inter alia,procedures forsampling, testing andcertification.Page83
(i) aprocedure exists toreview complaints concerning theoperation ofsuchprocedures
andtotakecorrective action when acomplaint isjustified.
Where animporting Member operates asystem fortheapproval oftheuseoffoodadditives orfor
theestablishment oftolerances forcontaminants infood, beverages orfeedstuffs which prohibits or
restricts access toitsdomestic markets forproducts based ontheabsence ofanapproval, theimporting
Member shallconsider theuseofarelevant international standard asthebasis foraccess untilafinal
determination ismade.
2. Where asanitary orphytosanitary measure specifies control atthelevel ofproduction, the
Member inwhose territory theproduction takesplace shallprovide thenecessary assistance tofacilitate
suchcontrol andthework ofthecontrolling authorities.
3. Nothing inthisAgreement shallprevent Members from carrying outreasonable inspection
within theirownterritories.