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Oursubmissionguidelinesandfurtherinformationareavailableat http://www.unimaas.nl/maastrichtworkingpapers ©PeterVandenBossche,DenisePrévostandMariëlleMatthee PublishedinMaastricht,October2005 FacultyofLaw UniversiteitMaastricht Postbox616 6200MD Maastricht TheNetherlands Authoremails: p.vandenbossche@ir.unimaas.nl,d.prevost@ir.unimaas.nl&m.matthee@asser.nl ThispaperistobecitedasMaastrichtFacultyofLawWorkingPaper2005/6 3 WTORulesonTechnicalBarrierstoTrade PeterVandenBossche, DenisePrévostandMariëlleMatthee 1 TABLEOFCONTENTS 1. Introduction 4 2. TheTBTAgreement 5 2.1. ScopeofApplicationoftheTBTAgreement 5 2.2. RelationshipwithOtherWTOAgreements 13 2.3. BasicSubstantiveProvisionsoftheTBTAgreement 14 2.4. OtherSubstantiveProvisions 21 2.5. InstitutionalandProceduralProvisions 24 2.6. SpecialProvisionsforDevelopingCountries 26 3. TheSPSAgreement 27 3.1. ScopeofApplicationoftheSPSAgreement 28 3.2. RelationshipwithOtherWTOAgreements 31 3.3. BasicPrinciplesoftheSPSAgreement 33 3.4. RiskAnalysisObligations 44 3.5. OtherSubstantiveProvisions 62 3.6. InstitutionalandProceduralProvisions 69 3.7. SpecialProvisionsforDevelopingCountries 75 4. Summary 77 ABSTRACT Inmodernsociety,productsareoftensubjecttorequirementsrelatingtotheircharacteristics and/orthemannerinwhichtheyareproduced.Thepurposeoftheserequirementsmaybethe protection oflife or health, the protection ofthe environment, theprevention ofdeceptive practicesortoensurethequalityofproducts.Theserequirementsmayconstituteformidable barriers to trade. Moreover, procedures set up to verify whether a product meets certain requirementsmayobstructtrade.Thesebarrierstotradearereferredtoastechnicalbarriers totrade.Onemustdistinguishbetween: • thegeneralcategoryoftechnicalbarrierstotrade,forwhichruleshavebeensetoutin theTBTAgreement;and • a special category of technical barriers to trade, namely sanitary and phytosanitary measures,forwhichrulesareprovidedintheSPSAgreement. The rules of the TBT Agreement and the SPS Agreement are of great importance to internationaltrade.TheygosignificantlybeyondtheGATTobligationsnottodiscriminate 1 PeterVandenBosscheisProfessorofInternationalEconomicLawandHeadoftheInternationalandEuropeanLawDepartment attheFacultyofLawofMaastrichtUniversity.From1997to2001,hewasCounsellortotheAppellateBodyoftheWTO.In2001 heservedasActingDirectoroftheAppellateBodySecretariat.DenisePrévostisalecturerininternationaleconomiclawatthe FacultyofLawofUtrechtUniversity,MariëlleMattheeisadoctoralresearcherattheFacultyofLawofMaastrichtUniversity. TheauthorswishtothankMaikelBeckersandJillRochefortheirableassistanceinpreparingthisworkingpaperforpublication. 4 amongoragainstimportedproductsornottoimposequantitativerestrictionsbutalsoimpose certain international disciplines on national regulation regarding products, their characteristics and production. This working paper gives an overview of the scope of application as well as the substantive and institutional/procedural provisions of the TBT AgreementandtheSPSAgreement. Keywords: WTOlaw, MarketAccess,TechnicalBarriersto Trade,TBTAgreement,SPS Agreement. 1. INTRODUCTION TVsets, toys,cosmetics, medical equipment,fertilisers,meatand cheese areall subject to requirementsrelatingtotheircharacteristicsand/orthemannerinwhichtheyareproduced. Thepurposeoftheserequirementsmaybetheprotectionoflifeorhealth,theprotectionof theenvironment,thepreventionofdeceptivepracticesortoensurethequalityofproducts. These requirements may be mandatory, set and enforced by governments. More often, however,theserequirements areruleslaid downbynationalstandardisation bodies,which arenotmandatorybutareneverthelessgenerallyadoptedinbusinesstransactionsinagiven country. Inbothcases,theserequirements may constituteformidable barrierstotrade.TV setsandcheese madeaccordingto therequirements ofcountryAmaybebannedfrom, or difficult to market in, country B when the requirements of country B relating to the characteristics or the manner of production are different. Furthermore, procedures used to verify whether a product meets certain mandatory or voluntary requirements may obstruct trade. Measuresof thiskindarecommonlyreferredto as‘technicalbarrierstotrade’.Thispaper dealswiththeWTOlawonsuchbarriers.Onemustdistinguishbetween: • thegeneralcategoryoftechnicalbarrierstotrade,forwhichruleshavebeensetoutin the Agreement on Technical Barriers to Trade, commonly referred to as the TBT Agreement;and • a special category of technical barriers to trade, namely sanitary and phytosanitary measures, for which rules are provided in the Agreement on the Application of SanitaryandPhytosanitaryMeasures,commonlyreferredtoastheSPSAgreement. The rules of the TBT Agreement and the SPS Agreement are of great importance to international trade. As discussed below, these rules go significantly beyond the GATT obligations not to discriminate among or against imported products. They impose certain 5 internationaldisciplines onnational regulationregarding products,their characteristics and production. 2. THETBTAGREEMENT Asnotedabove,theWTOrulesonthegeneralcategoryoftechnicalbarrierstotradeareset outintheTBTAgreement.Thissectiondiscusses: • thescopeofapplicationoftheTBTAgreement; • the relationship between the TBT Agreement and other WTO agreements, in particular,theSPSAgreementandtheGATT1994; • thesubstantiveprovisionsoftheTBTAgreement • theinstitutionalandproceduralprovisionsoftheTBTAgreement;and • specialprovisionsfordevelopingcountryMembers. 2.1. ScopeofApplicationoftheTBTAgreement With respect to the scope of application of the TBT Agreement, this section distinguishes between the substantive scope of application, i.e., the types of measures to which the agreementapplies,thepersonalscopeofapplication,i.e.,theentitiestowhomrulesofthe TBTAgreementapply,andthetemporalscopeofapplicationoftheagreement. 2.1.1. Substantivescopeofapplication TherulesoftheTBTAgreementapplyto: • technicalregulations; • standards;and • conformityassessmentprocedures. AstheAppellateBodystatedinEC-Asbestos,theTBTAgreementthusappliestoa‘limited classofmeasures’. 2 Thethree typesof measurestowhichthe TBTAgreementapplies, are definedinAnnex1oftheTBTAgreement. InAnnex1.1,atechnicalregulationisdefinedas: 2 AppellateBodyReport,EC–Asbestos,para.80. 6 … [a] document which lays down product characteristics ortheir relatedprocesses and production methods, includingtheapplicableadministrativeprovisions,withwhichcomplianceismandatory.Itmayalsoincludeor deal exclusively withterminology,symbols,packaging, markingor labellingrequirementsas theyapplyto a product,processorproductionmethod. For example, a law requiring that batteries of 9 Volts or more be rechargeable, or a law requiringthatwinebesoldingreenglassbottlesaretechnicalregulationswithinthemeaning oftheTBTAgreement.Alawrequiringthattheproductionofpharmaceuticalproductsmeet certain requirements regarding manufacturing practices and plant cleanliness is also a technicalregulationfallingwithinthescopeofapplicationoftheTBTAgreement. Annex1.2oftheTBTAgreementdefinesastandardas: …[a]documentapprovedbyarecognisedbody,thatprovides,forcommonandrepeateduse,rules,guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory.Itmayalsoincludeordealexclusivelywithterminology,symbols,packaging,markingorlabelling requirementsastheyapplytoaproduct,processorproductionmethod. Contrarytotechnicalregulations,standardsareofavoluntarynature,meaningcomplianceis notmandatory. The voluntary standards set by CENELEC (the European Committee for Electrotechnical Standardisation), such as standards for mobile phones or handheld computers, are clearly standardswithinthemeaningoftheTBTAgreement. Inadditiontotechnicalregulationsandstandards,conformityassessmentproceduresalsofall withinthescopeofapplicationoftheTBTAgreement.Conformityassessmentproceduresare definedinAnnex1.3oftheTBTAgreementas: …anyprocedureused,directlyorindirectly,todeterminethatrelevantrequirementsintechnicalregulationsor standardsarefulfilled. Examples of conformity assessment procedures include, for example, procedures for sampling,testingandinspection. TheTBTAgreementappliestotechnicalregulations,standardsandconformityassessment proceduresrelatingto: • products(bothindustrialandagricultural);and 7 • processesandproductionmethods(PPMs). 3 Itisasubjectofmuchdebate,however,whethertheprocessesandproductionmethods, to whichtheTBTAgreementapplies,includetheso-callednon-productrelatedprocessesand productionmethods(NPR-PPMs).Thistermreferstoprocessesandproductionmethodsthat do not affect the characteristics of the final product put on the market. An example of a technicalregulationconcerningaNPR-PPMistheprohibitionoftheuseofenvironmentally unfriendly sources of energy in the production of a product. Another example is the prohibition to market beef from cattle fed with genetically modified fodder. During the negotiationsontheTBTAgreement,discussiontookplaceonwhetherthisgroupshouldbe included in the scope of the agreement. This discussion, however, did not result in consensus. 4 The definitions in Annex 1, paragraphs 1 to 3,seem to indicatethat technical regulations,standardsandconformityassessmentproceduresrelatingtoNPR-PPMsdonot fallwiththescopeofapplicationoftheTBTAgreement. 5 Intwodisputestodate,EC– AsbestosandEC –Sardines,panelsandtheAppellate Body had occasion to examine whether the measures at issue were technical regulations falling withinthescopeoftheTBTAgreement.InEC–Asbestos,themeasureatissueconsistedof, ononehand,ageneralbanonasbestosandasbestos-containingproductsand,ontheother hand,limitedexceptionsreferringtosituationsinwhichasbestos-containingproductswould beallowed.ThePanelconcludedthatthebanitselfwasnotatechnicalregulation,whereas theexceptionstothebanwere. 6 Onappeal,theAppellateBodyreversedthePanel’sfinding thatthebandidnotconstituteatechnicalregulation.Inaddressingthisissue,theAppellate Body first firmly rejected the Panel’s approach of considering separately the ban and the exceptionstotheban.AccordingtotheAppellateBody,the‘properlegalcharacter’ofthe measure cannot be determined unless the measure is looked at as a whole. The Appellate Bodystated: Article 1 of the Decree contains broad, general prohibitions on asbestos and products containing asbestos. However,thescopeandgeneralityofthoseprohibitionscanonlybeunderstoodinlightoftheexceptionstoit which, albeit for a limited period, permit, inter alia, the use of certain products containing asbestos and, 3 Article1.3andtheexplanatorynotetoAnnex1,paragraph2,oftheTBTAgreement.NotethattheTBT Agreementdoesnotapplytotechnicalregulations,standardsandconformityassessmentproceduresthat dealwithservices. 4 CommitteeonTechnicalBarrierstoTrade,‘NegotiatingHistoryoftheCoverageoftheAgreementon TechnicalBarrierstoTradewithregardtoLabellingRequirements,VoluntaryStandardsandProcesses and Production Methods Unrelated to Product Characteristics’, Note by the Secretariat, G/TBT/W11, dated29August1995. 5 Note that the definitions in Annex 1.1 and Annex 1.2 state: ‘ …products and related processes and productionmethods’.[Emphasisadded] 6 PanelReport,EC–Asbestos,paras.8.63and8.70 8 principally,productscontainingchrysotileasbestosfibres.Themeasureis,therefore,notatotalprohibitionon asbestos fibres, becauseit also includesprovisions thatpermit, fora limited duration, the use of asbestos in certainsituations.Thus,tocharacterizethemeasuresimplyasageneralprohibition,andtoexamineitassuch, overlooksthecomplexitiesofthemeasure,whichincludebothprohibitiveandpermissiveelements. 7 The Appellate Body thus concluded that the measure at issue was to be examined as an integrated whole, taking into account as appropriate the prohibitive and the permissive elementsthatarepartofit. 8 TheAppellateBodythenexaminedwhetherthemeasureatissue,consideredasawhole,was a technical regulation within the meaning of the TBT Agreement. On the basis of the definitionofa‘technicalregulation’ofAnnex1.1,quotedabove,theAppellateBodysetout anumberofconsiderationsfordeterminingwhetherameasureisatechnicalregulation.This sectiondiscussestheseconsiderations. First, for a measure to be a ‘technical regulation’, it must ‘lay down’ – i.e., set forth, stipulate,orprovide–‘productcharacteristics’.Withrespecttotheterm‘characteristics’,the AppellateBodynoted: … the “characteristics” of a product include, in our view, any objectively definable “features”, “qualities”, “attributes”, or other “distinguishing mark” of a product. Such “characteristics” might relate, inter alia, to a product’s composition, size, shape, colour, texture, hardness, tensile strength, flammability, conductivity, density,orviscosity.Inthedefinitionofa“technicalregulation”inAnnex1.1,theTBTAgreementitselfgives certain examples of “product characteristics” – “terminology, symbols, packaging, marking or labelling requirements”. Theseexamplesindicatethat “product characteristics” include,not only featuresand qualities intrinsic to the product itself, but also related “characteristics”, such as the means of identification, the presentationandtheappearanceofaproduct. 9 TheAppellateBodyalsonotedthatatechnicalregulationmaybeconfinedtolayingdown onlyoneorafewproductcharacteristics. Second,a‘technicalregulation’mustregulatethecharacteristicsofproductsinabindingor compulsoryfashion.AccordingtotheAppellateBody,itfollowsthat: 7 AppellateBodyReport,EC-Asbestos,para.64. 8 Ibid. 9 Ibid.,para.67. 9 … with respect to products, a “technical regulation” has the effect of prescribing or imposing one or more “characteristics”–“features”,“qualities”,“attributes”,orother“distinguishingmark”. 10 Product characteristics may be prescribed or imposed with respect to products in either a positiveoranegativeform.Thatis,thedocumentmayprovide,positively,thatproductsmust possesscertain‘characteristics’,orthedocumentmayrequire,negatively,thatproductsmust notpossesscertain‘characteristics’.Inbothcases,thelegalresultisthesame:thedocument ‘laysdown’certainbinding‘characteristics’forproducts. 11 Third, a ‘technical regulation’ must be applicable to an identifiable product, or group of products. Otherwise, enforcement of the regulation will be, in practical terms, impossible. Clearly,compliancewiththisobligationrequiresidentificationoftheproductcoverageofa technicalregulation. ThePanelinEC –Asbestosinterpretedthis tomeanthata‘technical regulation’mustapplyto‘given’productswhichareactuallynamed,identifiedorspecified intheregulation.TheAppellateBodydisagreed.NothinginthetextoftheTBTAgreement suggeststhattheproducts concerned needbenamedor otherwiseexpressly identifiedin a ‘technicalregulation’.TheAppellateBodynotedthat: …theremaybeperfectlysoundadministrativereasonsforformulatinga“technicalregulation”inawaythat doesnot expresslyidentifyproductsbyname,butsimplymakesthemidentifiable–forinstance, throughthe “characteristic”thatisthesubjectofregulation. 12 Onthebasisoftheabovethreeconsiderations,theAppellateBodyexaminedthemeasureat issue in EC – Asbestos, a French Decree, noting that the first and second paragraphs of Article1oftheDecreeimposedaprohibitiononasbestosfibres.AccordingtotheAppellate Body,prohibitiononthesefibresdoesnot,initself,prescribeorimposeany‘characteristics’ onasbestosfibresbutsimplybansthemin theirnaturalstate.Accordingly,if thismeasure consisted only of a prohibition on asbestos fibres, it might not constitute a ‘technical regulation’.TheAppellateBodythennoted,however: Anintegralandessentialaspectofthemeasureistheregulationof“productscontainingasbestosfibres”,which arealsoprohibitedbyArticle1, paragraphsIandIIoftheDecree. Itisimportanttonoteherethat,although formulatednegatively–productscontainingasbestosareprohibited–themeasure,inthisrespect,effectively prescribesorimposescertainobjectivefeatures,qualitiesor“characteristics”onallproducts.Thatis,ineffect, the measure provides that all products must not contain asbestos fibres. Although this prohibition against 10 Ibid.,para.68. 11 Ibid.,para.69. 12 Ibid.,para.70. 10 products containing asbestos applies to a large number of products, and although it is, indeed, true that the productstowhichthisprohibitionappliescannotbedeterminedfromthetermsofthemeasureitself,itseemsto usthattheproductscoveredbythemeasureareidentifiable:allproductsmustbeasbestosfree;anyproducts containing asbestos are prohibited. We also observe that compliance with the prohibition against products containingasbestosismandatoryandis,indeed,enforceablethroughcriminalsanctions. 13 Theprohibitionofallasbestos-containingproductsisameasurewhicheffectivelyprescribes –althoughnegatively–certainobjectivecharacteristicsforallproducts. Furthermore,theAppellateBodynotedthatArticles2,3and4oftheDecreecontaincertain exceptionstotheprohibitionsfoundinArticle1oftheDecree.Anypersonseekingtoavail oftheselimitedexceptionsmustprovideadetailedjustificationtotheauthorities,complete with necessary supporting documentation concerning ‘the state of scientific and technological progress’. Compliance with these administrative requirements is mandatory. Through the exceptions to the prohibitions, the measure at issue sets out the ‘applicable administrative provisions, with which compliance is mandatory’ for products with certain objective‘characteristics’. TheAppellateBodythusconcludedinEC-Asbestos: Viewing the measure asan integrated whole, we see that it lays down “characteristics” for allproducts that mightcontainasbestos,andweseealsothatitlaysdownthe“applicableadministrativeprovisions”forcertain products containing chrysotile asbestos fibres which are excluded from the prohibitions in the measure. Accordingly,wefindthatthemeasureisa“document”which“laysdownproductcharacteristics…including theapplicableadministrativeprovisions,withwhichcomplianceismandatory.”Forthesereasons,weconclude thatthemeasureconstitutesa“technicalregulation”undertheTBTAgreement. 14 ConfirmingitsrulinginEC–Asbestos,theAppellateBodyinEC–Sardinesestablisheda three-tiertestfor determining whetherameasure isa‘technical regulation’ undertheTBT Agreement: • themeasuremustapplytoanidentifiableproductorgroupofproducts; • themeasuremustlaydownproductcharacteristics;and • compliance with the product characteristics laid down in the measure must be mandatory. 13 Ibid.,para.72. 14 Ibid.,para.75. [...]... ‘weighing and balancing’ the above mentioned and other factors and elements 2.3.3 Use of international standards The harmonisation of national technical regulations and standards around international standards greatly facilitates the conduct of international trade. 38 Harmonisation around international standards diminishes the trade restrictive effect of technical barriers to trade by minimising the variety... proposed technical regulation, to discuss these comments upon request, and to take the comments and the resulting discussion into account when eventually deciding on the technical regulation When a technical regulation is adopted to address an urgent problem of safety, health, environmental protection or national security, a Member may set aside the notification (and consultation) requirements set out... specified risks The negotiators of the WTO agreements considered that these measures merited special attention due to their close link to agricultural trade, a sector of trade notoriously difficult to liberalise As a result, sanitary and phytosanitary measures are dealt with in a separate agreement, the Agreement on the Application of Sanitary and Phytosanitary Measures, commonly referred to as the SPS Agreement... proposed technical regulation can still be made and comments can be taken into account; • provide other Members, upon their request, with copies of and information on the proposed technical regulation, including information on how the proposed technical regulation deviates from relevant international standards; and • allow a reasonable time for other Members to make comments on the proposed technical. .. conformity assessment bodies Members are encouraged to enter into negotiations for the conclusion of agreements acknowledging mutual recognition of the results of each other’s conformity assessment procedures.48 Article 9 of the TBT Agreement encourages the adoption of, and participation in, international and regional systems for conformity assessment Such systems aim for cooperation between national... states to become acquainted with the proposed technical requirement; 48 See Article 6.3 of the TBT Agreement 22 • notify other Members through the WTO Secretariat of the products to be covered by the proposed technical regulation, together with a brief indication of the objective and rationale of the technical regulation This notification must be done at an early stage of the process, when amendments to. .. would constitute a violation of the national treatment obligation set out in Article 2.1 of the TBT Agreement 31 32 See Appellate Body Report, EC - Asbestos, para 80 Therefore, caution needs to be used when transposing interpretation given to these obligations under GATT 1994 to the similar provisions in the TBT Agreement The different context, structure and formulation of the TBT Agreement’s provisions... basis for their technical regulations …39 36 37 38 39 With regard to conformity assessment procedure, Article 5.1.1 states that risks of non-conformity shall be taken into account Annex 3.E (standards) does not contain the provision of risks to be taken into account As the TBT Agreement does not explicitly require a quantitative evaluation of risk, one could conclude, in line with the decision of the Appellate... information provided to the technical expert group is of a confidential nature, the parties to the dispute shall have access to that information.60 To date, panels have not yet made use of the possibility to establish a technical expert group As mentioned above, not only central government bodies but also local government and nongovernmental entities may adopt and apply technical regulations, standards... apply technical regulations, standards and conformity 55 56 57 58 59 60 See Article 15.4 of the TBT Agreement Committee on Techincal Barriers to Trade, Third Triennial Review of the Operation and Implementation of the Agreement on Technical Barriers to Trade, G/TBT/13, dated 11 November 2003 See Article 14.1 of the TBT Agreement For a detailed discussion of the WTO dispute settlement system, see P Van . certain requirementsmayobstruct trade. These barriers to trade arereferred to as technical barriers to trade. Onemustdistinguishbetween: • thegeneralcategoryof technical barriers to trade, forwhich rules havebeensetoutin theTBTAgreement;and •. requirements may obstruct trade. Measuresof thiskindarecommonlyreferred to as technical barriers to trade .Thispaper dealswiththe WTO law on such barriers. Onemustdistinguishbetween: •. as technical barriers to trade .Thispaper dealswiththe WTO law on such barriers. Onemustdistinguishbetween: • thegeneralcategoryof technical barriers to trade, forwhich rules havebeensetoutin the Agreement on Technical Barriers to Trade, commonly referred to as the TBT Agreement;and •