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The WTO Agreements SeriesSanitary and

Phytosanitary Measures


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The WTOagreements series

The WTOs agreements are the legal foundation for the international trading system that isused by the bulk of the worlds trading nations. This series offers a set of handy referencebooklets on selected agreements. Each volume contains the text of one agreement, anexplanation designed to help the user understand the text, and in some cases supplementarymaterial. They are intended to be an authoritative aid for understanding the agreements,

but because of the legal complexity of the agreements, the introductions cannot be takenas legal interpretations of the agreements.

The agreements were the outcome of the 19861994 Uruguay Round of world tradenegotiations held under the auspices of what was then the GATT (the General Agreement onTariffs and Trade). The full set is available inThe Results of the Uruguay Round of Multilateral Trade Negotiations: The Legal Texts . It includes about 60 agreements, annexes, decisions andunderstandings, but not the commitments individual countries made on tariffs and services. Afull package of agreements that includes over 20,000 pages of commitments is available fromWTO Publications in a 34-volume set, as well as a CD-ROM,The Results of the Uruguay Round .

The volumes in this series Agreement Establishing the WTO

Agriculture

GATT 1994 and 1947

Sanitary and Phytosanitary Measures

Technical Barriers to Trade


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ContentsIntroduction

The basicstructure of WTO

agreements

The SPSAgreement:

An overview

Frequently-askedquestions

Agreement onthe Applicationof Sanitary and

Phytosanitary

Measures(the legal text)

Annexes to SPSAgreement

Abbreviations

3

5

9

13

27

37

45


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3Sanitary and Phytosanitary Measures

Introduction

The Agreement on the Application of Sanitary and Phytosanitary Measures (theSPS Agreement) entered into force with the establishment of the World TradeOrganization on 1 January 1995. It concerns the application of food safety and animaland plant health regulations.

This booklet discusses the text of the SPS Agreement as it appears in the Final Act of the

Uruguay Round of Multilateral Trade Negotiations, signed in Marrakesh on 15 April 1994.This Agreement and others contained in the Final Act, along with the General Agreementon Tariffs and Trade as amended (GATT 1994), are part of the treaty which establishedthe World Trade Organization (WTO). The WTO superseded the GATT as the umbrellaorganization for international trade.

The WTO Secretariat has prepared this booklet to assist public understanding of theSPS Agreement. The rst section of the booklet presents the basic structure of WTOagreements; the second looks at the key features of the SPS Agreement; the thirdaddresses a number of frequently-asked questions; and the fourth is the legal text of theagreement. The booklet is not intended to provide a legal interpretation of the agreement.


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The basic structure ofWTO agreements

The conceptual framework Broadly speaking, the WTO agreementsfor the two largest areas of trade goods

and services share a common three-partoutline, even though the detail is sometimesquite different (see Figure 1).

They start with broad principles: the GeneralAgreement on Tariffs and Trade (GATT) (forgoods), and the General Agreement onTrade in Services (GATS). The Agreementon Trade-Related Aspects of IntellectualProperty Rights (TRIPS) also falls into thiscategory although it has no additional parts.

Fi u 1: Th a ic t uctu of th WTO a t

Umbrella AgreemenT esTAbl s ng T e WTO

good s vic t ctuap op ty

Basic principles GATT GATS TRIPS

Additional detailsOther goodsagreements andannexes

Services annexes

Market accesscommitments

Countriesschedules ofcommitments

Countriesschedules ofcommitments (andMFN exemptions)

Dispute settlement D sPUTe seTTlemenT

Transparency TrADe POl CY reV eWs


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The legal framework

The conceptual structure is re ected in theway the legal texts are organized. The shortMarrakesh Agreement Establishing theWorld Trade Organization sets up the legaland institutional foundations. Attached toit is a much lengthier set of four annexes.

Annex 1 contains most of the detailedrules, and is divided into three sections:

1A, containing the revised GeneralAgreement on Tariffs and Trade,the other agreements governing

trade in goods, and a protocol whichties in individual countries speci ccommitments on goods;

1B, the General Agreement on Tradein Services, texts on speci c servicessectors, and individual countriesspeci c commitments and exemptions;and

1C, the Agreement on Trade-RelatedAspects of Intellectual Property Rights.

Collectively, the agreements included inAnnex 1 are referred to as the MultilateralTrade Agreements, since they comprise thesubstantive trade policy obligations whichall the members of the WTO have accepted.

Annex 2 sets the rules and proceduresfor dispute settlement.

Annex 3 provides for regular reviews ofdevelopments and trends in national andinternational trade policy.

Annex 4 covers the plurilateralagreements which are within the WTOframework but which have limitedmembership.

Finally, the Marrakesh texts include anumber of decisions and declarations on awide variety of matters that were adopted atthe same time as the WTO Agreement itself.


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Problem: How do you ensure that yourcountrys consumers are supplied with foodthat is safe to eat safe at the level youconsider appropriate? And at the same time,

how can you ensure that unnecessary healthand safety regulations are not used as anexcuse to protect domestic producers fromforeign competition?

The Agreement on the Application ofSanitary and Phytosanitary Measures (theSPS Agreement) sets out the basic rulesfor food safety and animal and plant healthrequirements.

It allows countries to set their own standards.However, it also speci es that regulationsmust be based on scienti c ndings andshould be applied only to the extent thatthey are necessary to protect human,animal or plant life or health; they shouldnot unjusti ably discriminate betweencountries where similar conditions exist.

WTO member countries are encouraged touse the standards developed by the relevantinternational bodies whenever they exist.However, members may use measures whichresult in higher levels of health protection,so long as their measures are based on anappropriate assessment of risks and theapproach is consistent, not arbitrary.

The agreement sets out a framework forwhat countries can do, but is not prescriptive

The SPS Agreement:An overview

in how countries use health standards andmethods of inspecting products.

Key featuresAll countries maintain measures to ensurethat food is safe for consumers, and toprevent the spread of pests or diseasesamong animals and plants. These sanitaryand phytosanitary measures can take manyforms, such as requiring products to comefrom a disease-free area, inspection ofproducts, speci c treatment or processing ofproducts, setting allowable maximum levelsof pesticide residues or limiting the permitteduse of additives in food. Sanitary (humanand animal health) and phytosanitary (planthealth) measures apply to domestically-produced food or local animal and plantdiseases, as well as to products coming fromother countries.

Protection or protectionism?

Sanitary and phytosanitary measures, bytheir very nature, may result in restrictions ontrade. All governments accept the fact thatsome trade restrictions may be necessaryto ensure food safety and animal and planthealth protection. However, governments aresometimes pressured to go beyond whatis needed for health protection and usesanitary and phytosanitary restrictions to


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10 WTO Agreements Series

shield domestic producers from economiccompetition. A sanitary or phytosanitaryrestriction which is not actually requiredfor health reasons can be a very effectiveprotectionist device and, because of itstechnical complexity, it can be a particularlydeceptive and dif cult barrier to challenge.

The SPS Agreement builds on previous GATTrules to restrict the use of unjusti ed sanitaryand phytosanitary measures for the purposeof trade protection. The basic aim of the SPSAgreement is to maintain the sovereign rightof any government to provide the level ofhealth protection it deems appropriate, but to

ensure that this sovereign right is not misusedfor protectionist purposes and do not result inunnecessary barriers to international trade.In other words, it strikes a balance betweenthe right of governments to protect healthand their desire to see goods ow smoothlyin international trade.

Justi cation of measures

The SPS Agreement therefore permitsgovernments to maintain appropriate sanitaryand phytosanitary protection. At the same time,it reduces the possibility that decisions arearbitrary and encourages consistent decision-making. Sanitary and phytosanitary measuresmust be applied for no other purpose than toensure that food is safe and that animals and

plants are healthy, or to protect a countrysterritory from pests. In particular, the agreementclari es which factors should be taken intoaccount when risks are assessed. Measuresto ensure food safety and to protect the healthof animals and plants should be based as faras possible on the analysis and assessment ofobjective scienti c data.

International standards

The SPS Agreement encouragesgovernments to apply national SPS measuresthat are consistent with internationalstandards, guidelines and recommendations.This process is often called harmonization.The WTO itself does not and will not developthese standards. However, most of theWTOs member governments participate inthe development of these standards in otherinternational bodies by leading scientists inthe eld and governmental experts on healthprotection. These standards are subject tointernational scrutiny and review.

International standards are often higher thanthose actually applied in many countries,including developed countries, but the SPSAgreement explicitly permits governmentsto choose their own standards. However, ifthe national requirement results in a greaterrestriction of trade, a country may be askedby its trading partners to provide scienti c justi cation demonstrating that the relevantinternational standard would not achievethe level of health protection the countryconsiders appropriate.

Adapting to conditions

Due to differences in climate, existing pestsor diseases, or food safety conditions, it is

not always appropriate to impose the samesanitary and phytosanitary requirements onfood, animal or plant products coming fromdifferent countries. Therefore, sanitary andphytosanitary measures sometimes vary,depending on the health situation in thecountry of origin or destination, of the food,animal or plant product concerned. This istaken into account in the SPS Agreement.

Governments should also recognize pest-and disease-free areas which may not


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correspond to political boundaries, andadapt their requirements so that they areappropriate for products from these areas,an approach known as regionalization. Theagreement, however, prohibits unjusti eddiscrimination in the use of sanitary andphytosanitary measures, whether in favourof domestic producers or among foreignsuppliers.

Alternative measures andequivalence

An acceptable level of risk can often be

achieved in alternative ways. Among thealternatives and on the assumptionthat they are technically and economicallyfeasible and provide the same level offood safety or animal and plant healthprotection governments should selectthose that do not restrict trade more thannecessary to meet their health objective.Furthermore, if another country can showthat the measures it applies provide thesame level of health protection, these shouldbe accepted as equivalent. This helps toensure that protection is maintained whileproviding the greatest quantity and varietyof safe foodstuffs for consumers, the bestavailability of safe inputs for producers, andhealthy economic competition. Equivalenceis one of the subjects regularly discussed inthe SPS Committee.

Risk assessment

Countries SPS measures must be based onan appropriate assessment of the actual risksinvolved. If asked, they must make knownwhat factors they took into consideration,the assessment procedures they used andthe level of risk they determined to beacceptable.

Transparency

The SPS Agreement makes sanitary andphytosanitary measures more transparent.Governments are required to notify eachother, through the WTO Secretariat, of anynew or changed sanitary and phytosanitaryrequirements which affect trade. Each WTOmember must also set up of ces (calledEnquiry Points) to respond to requests formore information on new or existing SPSmeasures, including how they justify theirrequirements and how they apply their foodsafety and animal and plant health regulations.By systematically communicating information

and exchanging experiences, WTO membergovernments can improve their nationalstandards. The increased transparencyalso protects consumers and tradingpartners alike from protectionism hiddenin unnecessary technical requirements.This information is now readily availablein a comprehensive online database, theSPS Information Management System(http://spsims.wto.org).

SPS Committee

A special committee has been establishedwithin the WTO as a forum for membergovernments to exchange informationon all aspects of the SPS Agreementsimplementation. The SPS Committee

reviews how countries are complying withthe agreement, discusses issues that mayimpact on trade and maintains close co-operation with technical organizations in theeld. If a legal dispute arises on a sanitaryor phytosanitary measure, the normal WTOdispute settlement procedures are used,and advice from appropriate scienti cexperts can be sought.


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What are sanitary andphytosanitary measures? Doesthe SPS Agreement cover a

countrys measures to protectthe environment, its consumerinterests and animal welfare?

Sanitary refers to human and animal health,including food safety, and phytosanitarymeans plant health. For the purposes of theSPS Agreement, sanitary and phytosanitarymeasures are de ned as any measures applied:

to protect human or animal life from risksarising from additives, contaminants,toxins or disease-causing organisms intheir food or beverages;

to protect human life from plant- or animal-carried diseases (known as zoonoses);

to protect animal or plant life from pests,diseases, or disease-causing organisms;

to prevent or limit other damage to a

country from the entry, establishment orspread of pests.

Sanitary and phytosanitary measuresinclude measures taken to protect thehealth of sh, forests and wildlife, as wellas farmed animals and plants.

Some measures for environmental protectionmay fall within the scope of the SPSAgreement (as de ned above), such asto avoid contaminating drinking water, to

Frequently-askedquestions

prevent farm soils or sh stocks from beingcontaminated by heavy metals, or to protectbiodiversity. Measures purely to protect

consumer interests or animal welfare arenot covered by the SPS Agreement. Theseconcerns, however, may be addressed by otherWTO agreements (i.e., the TBT Agreement see below or Article XX of GATT).

Werent governments allowed toprotect food safety and animaland plant health before the SPSAgreement?

Yes, since 1948, national food safety, animaland plant health measures which affecttrade were subject to GATT rules. One ofGATTs most important principles is non-discrimination. GATTs rst article (most-favoured nation) says products importedfrom different WTO member countries must

be treated equally. The third article says lawsand other requirements must not be tougheron imports than on domestically-producedproducts. These rules apply, for instance, topesticide residue and food additive limits,as well as to restrictions for animal or planthealth purposes. Article XI does not permitgovernments to impose import bans or limitson the quantities of imports permitted.

The GATT rules also contain an exception(Article XX:b) which permits countries


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to take measures necessary to protecthuman, animal or plant life or health as longas these do not unjusti ably discriminatebetween countries where the sameconditions prevail, or are not a disguisedrestriction to trade. In other words, wherenecessary, for the purposes of protectinghuman, animal or plant health, governmentscould impose more stringent requirementson imports than they required of domesticgoods, and could ban imports that presenteda serious health risk.

In the Tokyo Round of multilateral tradenegotiations (1974-79), an Agreement on

Technical Barriers to Trade was negotiated(the 1979 TBT Agreement or StandardsCode). Only some countries signed it.Although the primary purpose of thisagreement was not the regulation of sanitaryand phytosanitary measures, it covered alltechnical requirements including thoseresulting from food safety and animal andplant health measures, pesticide residuelimits, inspection requirements and labelling.

Governments that signed the 1979TBT Agreement agreed to use relevantinternational standards (such as thosefor food safety developed by the CodexAlimentarius Commission), except whenthey considered that these standardswould not adequately protect health. Theyalso agreed to notify other governments,

through the GATT Secretariat, of anytechnical regulations which were not basedon international standards. The 1979 TBTAgreement included provisions for settlingtrade disputes arising from the use of foodsafety and other technical restrictions.

Postscript: The original GATT was revised as partof the 1986-94 Uruguay Round. The revision isof cially GATT 1994. It incorporates the originalGATT 1947, much of which remains untouched. Therevised GATT is the WTOs umbrella treaty for trade in

goods. Its rules apply when not superseded by a morespeci c WTO agreement. For food safety and animaland plant health measures the rules of the SPSAgreement prevail over those of the updated GATT.

The Uruguay Round also updated the TBT Agreement.The older 1979 version took effect on 1 January1980. At the end of 1994, before it was supersededby the new version, its signatories were the EuropeanUnion (12 countries at the time, plus 8 countries whichsubsequently became members) and 26 others. TheUruguay Round made two broad changes: the WTOTBT Agreement revised the original version, and hasbeen signed by all WTO members as part of thesingle undertaking, which also includes the SPS

Agreement and the majority of WTO treaties.

Why have an SPS Agreement?

Because sanitary and phytosanitarymeasures can so effectively restrict trade,WTO member governments want to haveclear rules on how they can be used. Whenthey negotiated the Uruguay Round, theywanted to reduce trade barriers, includingthrough the Agriculture Agreement.This increased fears that sanitary andphytosanitary measures might be used forprotectionist purposes.

The SPS Agreement is designed to close thispotential loophole. It sets out clearer, moredetailed rights and obligations for food safety

and animal and plant health measures whichaffect trade. Countries are permitted to imposeonly those requirements needed to protecthealth which are based on scienti c principles.

A government can challenge another countrysfood safety or animal and plant healthrequirements on the grounds that they are not justi ed by scienti c evidence. When asked,a country must make its procedures anddecisions available to others. Governmentshave to be consistent in their decisions on


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what safe food is and in their responses toanimal and plant health concerns.

How do you know if a measureis SPS or TBT? Does it makeany difference?

The scope of the two agreements is different(see Figure 2). The SPS Agreement covers allmeasures whose purpose is to protect:

human or animal health from food-bornerisks;

human health from animal- or plant-

carried diseases; animals and plants from pests or diseases; the territory of a country from damage

caused by pests;

whether or not these are technicalrequirements. The TBT (Technical Barriers to Trade)Agreement covers all technical regulations,voluntary standards and the procedures toensure that these are met, except when theseare sanitary or phytosanitary measures asde ned by the SPS Agreement.

The type of measure determines whether it iscovered by the TBT Agreement. The purposeof the measure is relevant in determiningwhether it is subject to the SPS Agreement.

TBT measures can cover any product, fromcar safety and energy-saving devices, to theshape of food cartons. To give some examplespertaining to human health, TBT measurescould include pharmaceutical restrictions, orthe labelling of cigarettes.

Most measures to control human diseasecome under the TBT Agreement, unless theyconcern diseases which are carried by plantsor animals (such as rabies or BSE). For food,

most labelling requirements, information onnutrition and quality and packaging regulationsare generally not considered to be sanitaryor phytosanitary measures and hence arenormally subject to the TBT Agreement.

On the other hand, regulations which addressthe microbiological contamination of food, orset allowable levels of pesticide or veterinarydrug residues, or identify permitted foodadditives, fall under the SPS Agreement.Some packaging and labelling requirements,if directly related to the safety of the food,are also subject to the SPS Agreement.

The two agreements share some commonelements. These include basic obligations notto discriminate. They both require governmentsto notify proposed measures in advance. Bothrequire governments to set up informationof ces (Enquiry Points). Nonetheless,many of the substantive rules are different.For example, both agreements encouragegovernments to use international standards.However, under the SPS Agreement, if agovernment wants to set its own standards forfood safety or to protect animal and plant health,it has to base this on a scienti c assessmentof the potential health risks. In contrast,under the TBT Agreement, governments canuse other justi cations, such as fundamentaltechnological reasons or geographical factors,to set their own standards.

In addition, sanitary and phytosanitary measurescan only be used when necessary to protecthuman, animal or plant health, on the basis ofscienti c information. However, governmentscan use TBT regulations when necessary tomeet a number of objectives, such as nationalsecurity or to prevent deceptive practices. Theobligations that governments have acceptedare different under the two agreements, andtherefore it is important to know whethera measure is a sanitary or phytosanitarymeasure, or comes under the TBT Agreement.


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exa p

F ti iz Regulation on permitted fertilizer residue in food andanimal feed sPs

Speci cations to ensure fertilizer works effectively TbT

Speci cations to protect farmers from possible harmfrom handling fertilizer TbT

Food a i Regulation on permitted food safety: health warnings,use, dosage sPs

Regulation on size, construction/structure, safe handling TbT

Fi u 2: sPs o TbT?Which agreement does a measure come under?

Is it food, drink or feed, and is its objective to protect one of those from these risks?

hu a if a i a if p a t if a cou t y

additives,contaminants,toxins ordisease-causingorganisms infood or drink

plant- or animal-carried disease

additives,contaminants,toxins ordisease-causingorganisms infeed or drink

diseases disease-causing

or disease-

carryingorganisms

pests diseases disease-causing

or disease-carryingorganisms

pests entering,establishing orspreading

OTHERNOIs it a technical regulation, standard orprocedure for assessing whether a productconforms with a standard?

YES

TbTsPs

YES NO


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exa p

F uit Regulation on treatment of imported fruit to preventpests spreading sPs

Regulation on quality, grading and labelling of importedfruit TbT

bott d wat : p ci catio foth ott

Materials that can be used because safe for humanhealth sPs

Requirements: no residues of disinfectant, so water notcontaminated sPs

Permitted sizes to ensure standard volumes TbT

Permitted shapes to allow stacking and displaying TbTCi a tt pack t Government health warning: Smoking can seriously

damage your health: the labels objective is health butit is not about food, so it is not SPS

TbT

To u a iz

sPs a u typica y d a with: TbT a u typica y d a with:

additives in food or drink labelling of food, drink and drugs contaminants in food or drink grading and quality requirements for food poisonous substances in food or drink packaging requirements for food residues of veterinary drugs or pesticides

in food or drink packaging and labelling for dangerous

chemicals and toxic substances certi cation: food safety, animal or plant

health regulations for electrical appliances

processing methods with implications forfood safety

regulations for cordless phones, radioequipment, etc.

labelling requirements directly related tofood safety

textiles and garments labelling

plant/animal quarantine testing vehicles and accessories declaring areas free from pests or

disease regulations for ships and ship equipment

preventing disease or pests spreadingto a country

safety regulations for toys

other sanitary requirements for imports(e.g. imported pallets used to transportanimals)

etc

etc


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How do governments and thepublic know who is doing what?

The transparency provisions of the SPSAgreement are designed to ensure thatthe public and trading partners know aboutmeasures taken to protect human, animaland plant health. The agreement requiresgovernments to promptly publish all sanitaryand phytosanitary regulations. When othergovernments ask, they have to explain thereasons for any particular food safety oranimal or plant health requirement.

All WTO member governments must

maintain an Enquiry Point, an of cedesignated to receive and respond toany requests for information regardingthat countrys sanitary and phytosanitarymeasures. Such requests may be for copiesof new or existing regulations, information onrelevant agreements between two countries,or information about risk assessmentdecisions. Contact details for Enquiry Pointscan be consulted electronically through theSPS Information Management System (SPSIMS http://spsims.wto.org).

Whenever a government is proposing anew regulation (or modifying an existingone) which differs from an internationalstandard and may affect international trade,it must notify the WTO Secretariat, whichthen circulates the noti cation to other WTO

member governments. The noti cations arealso available to the public on the WTO websites Documents Online (http://docsonline.wto.org, search document symbolG/SPS/N/), or through the SPSInformation Management System (http://spsims.wto.org). Alternatively, noti cationscan be requested from the Enquiry Point ofthe country which is proposing the measure.

Governments have to submit the noti cationbefore a proposed new regulation isimplemented, so that trading partners

have an opportunity to comment. The SPSCommittee has developed recommendationson how the comments must be handled.(See document G/SPS/7/Rev.3 for moreinformation.)

Sometimes, governments have to act fastto deal with an emerging SPS situation bypromptly adopting a new SPS measure.Urgent measures should be temporary, untilsuf cient information is available to assesswhether they should be permanent. Whenacting in emergencies, governments mustnotify other members, through the WTOSecretariat, immediately after the adoption

of the new SPS measure. When theydetermine whether a permanent measureis needed, they must also consider anycomments submitted by other WTO membergovernments.

Does the SPS Agreementrestrict a governments abilityto establish food safety andplant and animal health laws?Are food safety or animal andplant health levels determinedby the WTO or some otherinternational institution?

The SPS Agreement explicitly recognizesthe right of governments to take measuresto protect human, animal and plant health,

as long as these are based on science, arenecessary for the protection of health, and donot unjusti ably discriminate among foreignsources of supply. Likewise, governmentsdetermine the food safety levels and animaland plant health protection in their countries.Neither the WTO nor any other internationalbody does this.

The SPS Agreement does, however,encourage governments to harmonizeor base their national measures onthe international standards, guidelines


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and recommendations developed inother international organizations. Theseorganizations are:

for food safety, the joint FAO/WHOCodex Alimentarius Commission (Codex);

for animal health, the World Organisationfor Animal Health (previously known asthe Of ce International des Epizooties -OIE);

and for plant health, the InternationalPlant Protection Convention (IPPC),based in FAO.

Most WTO member governments havelong participated in the work of theseorganizations to set limits for pesticides,contaminants or additives in food and toreduce the effects of pests and diseaseson animal and plant health. The work ofthese technical organizations is scrutinizedand reviewed internationally.

One problem is that international standardsare often so stringent that many countrieshave dif culties implementing them. Butbeing encouraged to use internationalstandards does not mean that countrieshave to accept them as a oor or ceilingfor national standards. National standardsdo not violate the SPS Agreement simplyby differing from international norms.

Governments can set requirements thatare stricter than the international standards.However, if governments do set their ownstandards, they may be required to justifytheir higher standards if the difference givesrise to a trade dispute. Their justi cationmust be based on an analysis of scienti cevidence and the risks involved.

What does harmonizationwith international food safetystandards mean? Does thisresult in weaker healthprotection, i.e., downwardharmonization?

Harmonization with international foodsafety standards means basing nationalrequirements on the standards developedby the FAO/WHOs Codex AlimentariusCommission. (Codex also develops standardsfor food quality, nutrition and labelling.These come under the TBT Agreement, notSPS.) Codex standards are not a lowest

common denominator. They are based onthe input of leading scientists in the eldand national experts on food safety. Theseare the same government experts who areresponsible for the development of nationalfood safety standards. For example, therecommendations for pesticide residuesand food additives are developed forCodex by international groups of scientistswho use conservative, safety-orientedassumptions and who operate withoutpolitical interference.

In many cases, the standards developed byCodex are higher than those of individualcountries, including developed countries.Governments may nonetheless choose touse higher standards than the internationalones, if the international standards do not

meet their health protection needs.


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Can governments take adequateprecautions in setting foodsafety and animal and planthealth requirements? Whatabout in emergencies or whenthere is not enough scienti cevidence to judge risks? Canunsafe products be banned?

The SPS Agreements allows three differenttypes of precautions:

First, safety margins are used routinelyto ensure governments take adequateprecautions to protect health; this comes

from risk assessment and determinationof acceptable levels of risk. Second, as each country determines

its own level of acceptable risk, it canrespond to national concerns aboutnecessary health precautions.

Third, the SPS Agreement clearly allows agovernment to take temporary measuresas a precaution when it considers thatthe scienti c evidence is not suf cient todecide whether a product or process issafe. This also allows governments to actimmediately in emergency situations.

There are many examples of governmentsbanning the production, sale and importof products because of scienti c evidence

that the products pose an unacceptable riskto human, animal or plant health. The SPSAgreement does not affect a governmentsability to ban products under these conditions.

Can food safety and animaland plant health requirementsbe set by local or regionalgovernments? Can there bedifferences in requirementswithin a country?

The SPS Agreement accepts that food safetyand animal and plant health regulations donot necessarily have to be set by the highestgovernmental authority. Differences withina country are allowed. However, if thesedifferences affect international trade, theyhave to meet the same requirements as ifthey were set by the national government.

The national government remains responsiblefor implementing the SPS Agreement,and should ensure that state or provincialgovernments also observe it. Governmentsshould use the services of non-governmentalinstitutions only if these comply with the SPSAgreement.

Does the SPS Agreement requirecountries to give priority totrade over food safety, or animaland plant health?

No, the SPS Agreement allows countriesto give food safety, animal and planthealth priority over trade, provided theycan demonstrate that their food safety andhealth requirements are based on science.

Each country has the right to assess the risksand determine what it considers to be anappropriate level of food safety and animaland plant health.

Once a country has decided on its acceptablelevel of risk, there are often a number ofalternative measures which may be used toachieve this protection (such as treatment,quarantine or increased inspection). The SPSAgreement says that when a governmentchooses among the alternatives, it must use


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measures which do not restrict trade any morethan is necessary to achieve its objectives toprotect health, assuming the measures aretechnically and economically feasible. Forexample, if a country faces a risk becauseof an exotic pest entering with its imports, itcould ban the imports or it could require theexporters to fumigate the shipment. Eithermethod could reduce the risk to the levelthat the government considers acceptable,but fumigation restricts trade less than anoutright ban.

Can national food safety

and animal and plant healthlegislation be challenged byother countries? Can privateentities bring trade disputesto the WTO? How are disputessettled in the WTO?

Since the General Agreement on Tariffs andTrade (GATT) entered into force in 1948,it has been possible for governments tochallenge other countries food safety andplant and animal health laws as arti cialbarriers to trade. The 1979 TBT Agreementalso had procedures for challenging anothersignatorys technical regulations, includingfood safety standards and animal and planthealth requirements. The SPS Agreementmakes more explicit not only the basis forfood safety and animal and plant health

requirements that affect trade but also thebasis for challenges to those requirements.While a nations ability to establish legislationis not restricted, a speci c food safety oranimal or plant health requirement canbe challenged by another country on thegrounds that there is not suf cient scienti cevidence to support the need for the traderestriction. The SPS Agreement providesgreater certainty for regulators and tradersalike, enabling them to avoid potentialcon icts.

As the WTO is an intergovernmentalorganization, only governments, not privateentities or non-governmental organizations,can submit trade disputes to the WTOsdispute settlement procedures. Non-governmental entities can, of course, maketrade problems known to their governmentand encourage the government to seekredress, if appropriate, through the WTO.

By accepting the WTO Agreement,governments have agreed to be boundby the rules in all of the multilateral tradeagreements attached to it, including the SPSAgreement. In the case of a trade dispute,

the WTOs dispute settlement proceduresencourage the governments involved tosettle out of court through consultations. Ifthe governments cannot resolve their dispute,they can choose to follow any of severalmeans of dispute settlement, includingthe good of ces, conciliation, mediationand arbitration. Alternatively, a governmentcan formally ask for an impartial disputesettlement panel of experts to hear all sidesof the dispute and to make recommendations.

In a dispute on SPS measures, the panelcan seek scienti c advice, and even setup a technical experts group. If the panelconcludes that a country is violating itsobligations under any WTO agreement, itwill normally recommend that the countrybring its measure into conformity with its

obligations. This could, for example, involveprocedural changes in the way a measureis applied, modi cation or elimination of themeasure altogether, or simply elimination ofdiscriminatory elements.

The panel submits its recommendationsfor consideration by the WTO DisputeSettlement Body (DSB), which consists ofWTO member countries. Countries in thedispute can appeal the panels ndings. Thenal ruling is adopted by the DSB, unless


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the DSB decides by consensus to reject it.If the measure is found to be wrong, thedefending country has to implement thepanels recommendations and to report onhow it has complied.

Have there been any formaldisputes involving the SPSAgreement? What have theybeen about?

Although only one panel was asked toconsider sanitary or phytosanitary tradedisputes during the 47 years of the former

GATT dispute settlement procedures, in therst 15 years since the establishment of theWTO, almost 40 complaints were formallylodged with reference to the SPS Agreement.This is not surprising as the agreementclari es the basis for challenging sanitaryor phytosanitary measures which restricttrade without scienti c justi cation. Therange of issues involved include inspectionand quarantine procedures, animal diseases,plant pests, the use of veterinary drugs onanimals, and genetically modi ed organisms.Dispute settlement panels have beenrequested to examine 14 of the complaints;the other disputes have been or are likely tobe settled through consultation.

More information on all of the SPS-relateddisputes is available on the WTO dispute

settlement gateway (www.wto.org/disputes).

Who was responsible fordeveloping the SPS Agreement?Did developing countriesparticipate in the negotiation ofthe SPS Agreement?

The decision to negotiate an SPS Agreementwas made in 1986 when the Uruguay Roundwas launched. The SPS negotiations were

open to all of the 124 governments whichparticipated. Many governments wererepresented by their food safety or animaland plant health protection of cials. Thenegotiators also drew on the expertise oftechnical international organizations such asFAO, Codex and OIE.

Developing countries participated in allaspects of the Uruguay Round negotiationsto an unprecedented extent, including onsanitary and phytosanitary measures. Bothbefore and during the Uruguay Roundnegotiations, the GATT Secretariat assisteddeveloping countries to establish effective

negotiating positions.

Has there been publicparticipation in the WTOs SPSwork or in negotiating the SPSAgreement? Are private sectorinterests or consumer interestsexcluded?

The WTO is an intergovernmentalorganization. Private entities and non-governmental organizations do not directlyparticipate in its work, but they havein uence through their contact with theirown governments. In addition, the WTOSecretariat maintains regular contact withmany non-governmental organizations.

GATT, like the WTO, was an intergovernmentalorganization. Therefore, only governmentsparticipated in the GATT Uruguay Round talksthat led to the SPS Agreement. However, thepublic debate was unprecedented, as manygovernments consulted with their public andprivate sectors and with non-governmentalorganizations on various aspects of thenegotiations, including the SPS Agreement.Some governments established formalchannels for public consultation and debate,while others did so less formally. The


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GATT Secretariat also had considerablecontact with international non-governmentalorganizations as well as with the public andprivate sectors of many countries involved inthe negotiations. The nal Uruguay Roundresults were subject to national rati cationand implementation processes in most GATTmember countries.

What is the SPS Committee andwho sits on it?

The SPS Agreement established a Committeeon Sanitary and Phytosanitary Measures

(the SPS Committee) to provide a forumfor governments to discuss food safety andanimal and plant health measures whichaffect trade, and to ensure the implementationof the SPS Agreement. The SPS Committee,like other WTO committees, is open toall WTO member countries. Observergovernments in the higher level WTO bodies(such as the Goods Council) are also eligibleto be observers in the SPS Committee.Representatives of several internationalintergovernmental organizations are alsoobservers, including Codex, OIE, IPPC, WHO,the United Nations Conference on Trade andDevelopment (UNCTAD) and the InternationalOrganization for Standardization (ISO). Someregional governmental bodies working onSPS issues are also observers. Governmentsmay send whichever delegates they believe

appropriate to participate in the meetings ofthe SPS Committee, and many send theirfood safety authorities or veterinary or planthealth of cials.

The SPS Committee usually holds threeregular meetings each year. It also regularlyholds informal meetings, and special meetingsor workshops to address particular issues.

What does the SPS Committeedo? What are the issues itconsiders?

Governments inform each other about theirregular and emergency SPS measuresthrough the Secretariat. They useprocedures and standardized formats thathave been reviewed periodically (documentG/SPS/7/Rev.3). The huge number ofnoti cations, submitted by virtually all WTOmembers, provides an opportunity for theirtrading partners to comment on plannedregulations before they are adopted, and forproducers to adapt to the new requirements.

The committee also considers informationprovided by governments regarding theirnational regulatory procedures, their useof risk assessment in the development ofsanitary and phytosanitary measures andthe status of diseases in their territories.For example, many countries haveprovided information on bovine spongiformencephalopathy (BSE or mad cow disease),avian in uenza (bird u), foot-and-mouthdisease and fruit y and on what they havedone to control these.

WTO members can also raise speci c tradeconcerns regarding SPS measures imposedby other members in the SPS Committee.Almost 300 speci c trade concerns, coveringthe full range of SPS issues, were raised in

the committees rst 15 years. This is anopportunity for countries to ask their tradingpartners to explain or justify requirementsthat make it dif cult for them to export. Thespeci c trade concerns raised in the SPSCommittee can be consulted through theSPS IMS (http://spsims.wto.org).

The SPS Committee monitors countriesuse of international standards, under aprovisional procedure required by Articles3.5 and 12.4 of the SPS Agreement


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publication of a new SPS measure and thedate of its entry into force must be not lessthan six months except in an emergency so as to allow suf cient time for exportersto comply with the importing markets newSPS requirements (WT/MIN(01)/17).

Importers of food and other agriculturalproducts also bene t from the greatercertainty of border measures. The agreementclari es the basis for restricting trade throughsanitary and phytosanitary measures. Thismakes the basis for challenging unjusti edrequirements clearer. It also bene ts themany processors and commercial users of

imported food or of animal or plant products.

What dif culties do developingcountries face in implementingthe SPS Agreement? Arethere special provisions fordeveloping countries?

Although a number of developing countrieshave excellent food safety and veterinaryand plant health services, others do not. Forthe latter, the agreements requirements cansometimes present a challenge to improvethe health situation of their people, livestockand crops. Because of this dif culty, theagreement allowed developing countries todelay meeting all requirements, other thanthose dealing with transparency (noti cation

and the establishment of Enquiry Points),until 1997, and until 2000 for the least-developed countries. Countries which needtime to implement certain programmes, forexample to improve their veterinary servicesor to implement speci c obligations of theagreement, can ask the SPS Committeeto grant them further delays. Developingcountries can also request special treatmentor technical assistance to meet importingcountries requirements (G/SPS/33/Rev.1).Many developing countries have already

adopted international standards (includingthose of Codex, OIE and IPPC) as the basisfor their own requirements, thus avoidingthe need to devote their scarce resources toduplicate work already done by internationalexperts. The agreement encourages themto participate as actively as possible inthese organizations, contributing to newinternational standards which address theirneeds.

Developing countries bene t from the six-month period that WTO members haveagreed between a measure being adoptedand coming into force (subject to certain

conditions, see WT/MIN(01)/17).

Do developing countries receiveany help in implementing theSPS Agreement? Who providesassistance? How is this done?

The SPS Agreement calls for assistancefor developing countries to enable themto strengthen their food safety and animaland plant health protection systems. Manyinternational organizations, including theFAO, WHO, OIE and the World Bank, operateprogrammes for developing countries inthese areas. Many countries also providedirect support, recognizing that the best wayto ensure the safety of the products theyare importing can be to ensure that they are

produced safely, following good agriculturalor manufacturing practices.

The WTO Secretariat also provides training toensure that of cials in developing countriesfully understand their obligations under theagreement, but also how to make use of theagreement to increase their exports andimprove health in their countries. Trainingis provided nationally, upon request fromgovernments, or regionally. Regional trainingis provided in cooperation with Codex, OIE


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and IPPC, to ensure that governments arefully aware of the role these organizationscan play in assisting countries to meet SPSrequirements and enjoy the bene ts of theagreement. The WTO Secretariat also offerse-Training courses on the agreement, andan intensive three-week advanced trainingcourse for of cials from developing countries.

A procedural step-by-step manual forSPS national Noti cation Authorities andEnquiry Points is available at www.wto.org/sps. Furthermore, a mentoring systemof assistance relating to the transparencyprovisions of the SPS Agreement has

been established to assist WTO developingcountry members (G/SPS/W/217). Thisdeals particularly with the operation of theSPS National Noti cation Authority and theNational Enquiry Point.

In 2001, the heads of the FAO, OIE, WHO, WTOand the World Bank agreed to work togetherto improve technical assistance in SPS. Thisled to the creation of the Standards and TradeDevelopment Facility (STDF), which servesto raise awareness of the importance ofcompliance with international SPS standardsand coordinates the provision of SPS-relatedtechnical assistance. The STDF also workson project development, the mobilization offunds, exchange of experiences and thedissemination of good practice in relationto the provision and receipt of SPS-related

assistance. Limited grant nancing is alsoavailable to developing countries seekingto gain and maintain market access bycomplying with international SPS standards.More information, including eligibility criteriaand application forms, is available on theSTDF website (www.standardsfacility.org).


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Agreement on the Applicationof Sanitary and Phytosanitary

Measures (the legal text)

Members,

Reaf rming that no Member should be prevented from adopting or enforcing measuresnecessary to protect human, animal or plant life or health, subject to the requirement thatthese measures are not applied in a manner which would constitute a means of arbitraryor unjusti able discrimination between Members where the same conditions prevail or adisguised restriction on international trade;

Desiring to improve the human health, animal health and phytosanitary situation in all Members;

Noting that sanitary and phytosanitary measures are often applied on the basis of bilateralagreements or protocols;

Desiring the establishment of a multilateral framework of rules and disciplines to guide thedevelopment, adoption and enforcement of sanitary and phytosanitary measures in order tominimize their negative effects on trade;

Recognizing the important contribution that international standards, guidelines andrecommendations can make in this regard;

Desiring to further the use of harmonized sanitary and phytosanitary measures between

Members, on the basis of international standards, guidelines and recommendations developedby the relevant international organizations, including the Codex Alimentarius Commission, theInternational Of ce of Epizootics, and the relevant international and regional organizationsoperating within the framework of the International Plant Protection Convention, withoutrequiring Members to change their appropriate level of protection of human, animal or plantlife or health;

Recognizing that developing country Members may encounter special dif culties in complyingwith the sanitary or phytosanitary measures of importing Members, and as a consequence inaccess to markets, and also in the formulation and application of sanitary or phytosanitarymeasures in their own territories, and desiring to assist them in their endeavours in this regard;


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Desiring therefore to elaborate rules for the application of the provisions of GATT 1994which relate to the use of sanitary or phytosanitary measures, in particular the provisionsof Article XX(b)1;

Hereby agree as follows:

Article 1General Provisions

1. This Agreement applies to all sanitary and phytosanitary measures which may, directlyor indirectly, affect international trade. Such measures shall be developed and applied inaccordance with the provisions of this Agreement.

2. For the purposes of this Agreement, the de nitions provided in Annex A shall apply.

3. The annexes are an integral part of this Agreement.

4. Nothing in this Agreement shall affect the rights of Members under the Agreementon Technical Barriers to Trade with respect to measures not within the scope of thisAgreement.

Article 2Basic Rights and Obligations

1. Members have the right to take sanitary and phytosanitary measures necessary for theprotection of human, animal or plant life or health, provided that such measures are notinconsistent with the provisions of this Agreement.

2. Members shall ensure that any sanitary or phytosanitary measure is applied only to the

extent necessary to protect human, animal or plant life or health, is based on scienti cprinciples and is not maintained without suf cient scienti c evidence, except as providedfor in paragraph 7 of Article 5.

3. Members shall ensure that their sanitary and phytosanitary measures do not arbitrarilyor unjusti ably discriminate between Members where identical or similar conditionsprevail, including between their own territory and that of other Members. Sanitary andphytosanitary measures shall not be applied in a manner which would constitute adisguised restriction on international trade.

1. In this Agreement, reference to Article XX(b) includes also the chapeau of that Article .


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4. Sanitary or phytosanitary measures which conform to the relevant provisions of thisAgreement shall be presumed to be in accordance with the obligations of the Membersunder the provisions of GATT 1994 which relate to the use of sanitary or phytosanitarymeasures, in particular the provisions of Article XX(b).

Article 3Harmonization

1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible,Members shall base their sanitary or phytosanitary measures on international standards,guidelines or recommendations, where they exist, except as otherwise provided for in thisAgreement, and in particular in paragraph 3.

2. Sanitary or phytosanitary measures which conform to international standards, guidelinesor recommendations shall be deemed to be necessary to protect human, animal orplant life or health, and presumed to be consistent with the relevant provisions of thisAgreement and of GATT 1994.

3. Members may introduce or maintain sanitary or phytosanitary measures which result in ahigher level of sanitary or phytosanitary protection than would be achieved by measuresbased on the relevant international standards, guidelines or recommendations, if thereis a scienti c justi cation, or as a consequence of the level of sanitary or phytosanitaryprotection a Member determines to be appropriate in accordance with the relevantprovisions of paragraphs 1 through 8 of Article 5.2 Notwithstanding the above, allmeasures which result in a level of sanitary or phytosanitary protection differentfrom that which would be achieved by measures based on international standards,guidelines or recommendations shall not be inconsistent with any other provision ofthis Agreement.

4. Members shall play a full part, within the limits of their resources, in the relevantinternational organizations and their subsidiary bodies, in particular the Codex Alimentarius

Commission, the International Of ce of Epizootics, and the international and regionalorganizations operating within the framework of the International Plant ProtectionConvention, to promote within these organizations the development and periodic reviewof standards, guidelines and recommendations with respect to all aspects of sanitary andphytosanitary measures.

2. For the purposes of paragraph 3 of Article 3, there is a scienti c justi cation if, on the basis of an

examination and evaluation of available scienti c information in conformity with the relevant provisions of thisAgreement, a Member determines that the relevant international standards, guidelines or recommendationsare not suf cient to achieve its appropriate level of sanitary or phytosanitary protection.


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5. The Committee on Sanitary and Phytosanitary Measures provided for in paragraphs 1and 4 of Article 12 (referred to in this Agreement as the Committee) shall develop aprocedure to monitor the process of international harmonization and coordinate effortsin this regard with the relevant international organizations.

Article 4Equivalence

1. Members shall accept the sanitary or phytosanitary measures of other Members asequivalent, even if these measures differ from their own or from those used by otherMembers trading in the same product, if the exporting Member objectively demonstratesto the importing Member that its measures achieve the importing Members appropriate

level of sanitary or phytosanitary protection. For this purpose, reasonable access shall begiven, upon request, to the importing Member for inspection, testing and other relevantprocedures.

2. Members shall, upon request, enter into consultations with the aim of achieving bilateraland multilateral agreements on recognition of the equivalence of speci ed sanitary orphytosanitary measures.

Article 5Assessment of Risk and Determination of the Appropriate Level ofSanitary or Phytosanitary Protection

1. Members shall ensure that their sanitary or phytosanitary measures are based on anassessment, as appropriate to the circumstances, of the risks to human, animal or plantlife or health, taking into account risk assessment techniques developed by the relevantinternational organizations.

2. In the assessment of risks, Members shall take into account available scienti c evidence;relevant processes and production methods; relevant inspection, sampling and testingmethods; prevalence of speci c diseases or pests; existence of pest- or disease-freeareas; relevant ecological and environmental conditions; and quarantine or other treatment.

3. In assessing the risk to animal or plant life or health and determining the measure to beapplied for achieving the appropriate level of sanitary or phytosanitary protection fromsuch risk, Members shall take into account as relevant economic factors: the potentialdamage in terms of loss of production or sales in the event of the entry, establishmentor spread of a pest or disease; the costs of control or eradication in the territory ofthe importing Member; and the relative cost-effectiveness of alternative approaches tolimiting risks.


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4. Members should, when determining the appropriate level of sanitary or phytosanitaryprotection, take into account the objective of minimizing negative trade effects.

5. With the objective of achieving consistency in the application of the concept of appropriatelevel of sanitary or phytosanitary protection against risks to human life or health, orto animal and plant life or health, each Member shall avoid arbitrary or unjusti abledistinctions in the levels it considers to be appropriate in different situations, if suchdistinctions result in discrimination or a disguised restriction on international trade.Members shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3of Article 12, to develop guidelines to further the practical implementation of this provision.In developing the guidelines, the Committee shall take into account all relevant factors,including the exceptional character of human health risks to which people voluntarilyexpose themselves.

6. Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary

or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitaryprotection, Members shall ensure that such measures are not more trade-restrictive thanrequired to achieve their appropriate level of sanitary or phytosanitary protection, takinginto account technical and economic feasibility.3

7. In cases where relevant scienti c evidence is insuf cient, a Member may provisionallyadopt sanitary or phytosanitary measures on the basis of available pertinent information,including that from the relevant international organizations as well as from sanitary orphytosanitary measures applied by other Members. In such circumstances, Members shallseek to obtain the additional information necessary for a more objective assessment ofrisk and review the sanitary or phytosanitary measure accordingly within a reasonableperiod of time.

8. When a Member has reason to believe that a speci c sanitary or phytosanitary measureintroduced or maintained by another Member is constraining, or has the potential toconstrain, its exports and the measure is not based on the relevant international standards,guidelines or recommendations, or such standards, guidelines or recommendations do notexist, an explanation of the reasons for such sanitary or phytosanitary measure may berequested and shall be provided by the Member maintaining the measure.

3. For purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than required unlessthere is another measure, reasonably available taking into account technical and economic feasibility, thatachieves the appropriate level of sanitary or phytosanitary protection and is signi cantly less restrictive totrade.


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Article 6Adaptation to Regional Conditions, Including Pest- or Disease-FreeAreas and Areas of Low Pest or Disease Prevalence

1. Members shall ensure that their sanitary or phytosanitary measures are adapted to thesanitary or phytosanitary characteristics of the area whether all of a country, partof a country, or all or parts of several countries from which the product originatedand to which the product is destined. In assessing the sanitary or phytosanitarycharacteristics of a region, Members shall take into account, inter alia, the levelof prevalence of speci c diseases or pests, the existence of eradication or controlprogrammes, and appropriate criteria or guidelines which may be developed by therelevant international organizations.

2. Members shall, in particular, recognize the concepts of pest- or disease-free areasand areas of low pest or disease prevalence. Determination of such areas shall bebased on factors such as geography, ecosystems, epidemiological surveillance, and theeffectiveness of sanitary or phytosanitary controls.

3. Exporting Members claiming that areas within their territories are pest- or disease-freeareas or areas of low pest or disease prevalence shall provide the necessary evidencethereof in order to objectively demonstrate to the importing Member that such areasare, and are likely to remain, pest- or disease-free areas or areas of low pest or diseaseprevalence, respectively. For this purpose, reasonable access shall be given, upon request,to the importing Member for inspection, testing and other relevant procedures.

Article 7Transparency

1. Members shall notify changes in their sanitary or phytosanitary measures and shall

provide information on their sanitary or phytosanitary measures in accordance with theprovisions of Annex B.

Article 8Control, Inspection and Approval Procedures

1. Members shall observe the provisions of Annex C in the operation of control, inspectionand approval procedures, including national systems for approving the use of additivesor for establishing tolerances for contaminants in foods, beverages or feedstuffs, and


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otherwise ensure that their procedures are not inconsistent with the provisions of thisAgreement.

Article 9Technical Assistance

1. Members agree to facilitate the provision of technical assistance to other Members,especially developing country Members, either bilaterally or through the appropriateinternational organizations. Such assistance may be, inter alia, in the areas of processingtechnologies, research and infrastructure, including in the establishment of nationalregulatory bodies, and may take the form of advice, credits, donations and grants,including for the purpose of seeking technical expertise, training and equipment to

allow such countries to adjust to, and comply with, sanitary or phytosanitary measuresnecessary to achieve the appropriate level of sanitary or phytosanitary protection in theirexport markets.

2. Where substantial investments are required in order for an exporting developing countryMember to ful l the sanitary or phytosanitary requirements of an importing Member, thelatter shall consider providing such technical assistance as will permit the developingcountry Member to maintain and expand its market access opportunities for the productinvolved.

Article 10Special and Differential Treatment

1. In the preparation and application of sanitary or phytosanitary measures, Members shalltake account of the special needs of developing country Members, and in particular ofthe least-developed country Members.

2. Where the appropriate level of sanitary or phytosanitary protection allows scope for thephased introduction of new sanitary or phytosanitary measures, longer time-frames forcompliance should be accorded on products of interest to developing country Membersso as to maintain opportunities for their exports.

3. With a view to ensuring that developing country Members are able to comply with theprovisions of this Agreement, the Committee is enabled to grant to such countries, uponrequest, speci ed, time-limited exceptions in whole or in part from obligations under thisAgreement, taking into account their nancial, trade and development needs.

4. Members should encourage and facilitate the active participation of developing countryMembers in the relevant international organizations.


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Article 11Consultations and Dispute Settlement

1. The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and applied bythe Dispute Settlement Understanding shall apply to consultations and the settlement ofdisputes under this Agreement, except as otherwise speci cally provided herein.

2. In a dispute under this Agreement involving scienti c or technical issues, a panel shouldseek advice from experts chosen by the panel in consultation with the parties to thedispute. To this end, the panel may, when it deems it appropriate, establish an advisorytechnical experts group, or consult the relevant international organizations, at the requestof either party to the dispute or on its own initiative.

3. Nothing in this Agreement shall impair the rights of Members under other internationalagreements, including the right to resort to the good of ces or dispute settlement mechanismsof other international organizations or established under any international agreement.

Article 12Administration

1. A Committee on Sanitary and Phytosanitary Measures is hereby established to providea regular forum for consultations. It shall carry out the functions necessary to implementthe provisions of this Agreement and the furtherance of its objectives, in particular withrespect to harmonization. The Committee shall reach its decisions by consensus.

2. The Committee shall encourage and facilitate ad hoc consultations or negotiations amongMembers on speci c sanitary or phytosanitary issues. The Committee shall encouragethe use of international standards, guidelines or recommendations by all Members and, inthis regard, shall sponsor technical consultation and study with the objective of increasing

coordination and integration between international and national systems and approachesfor approving the use of food additives or for establishing tolerances for contaminantsin foods, beverages or feedstuffs.

3. The Committee shall maintain close contact with the relevant international organizations inthe eld of sanitary and phytosanitary protection, especially with the Codex AlimentariusCommission, the International Of ce of Epizootics, and the Secretariat of the InternationalPlant Protection Convention, with the objective of securing the best available scienti cand technical advice for the administration of this Agreement and in order to ensure thatunnecessary duplication of effort is avoided.

4. The Committee shall develop a procedure to monitor the process of international


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harmonization and the use of international standards, guidelines or recommendations.For this purpose, the Committee should, in conjunction with the relevant internationalorganizations, establish a list of international standards, guidelines or recommendationsrelating to sanitary or phytosanitary measures which the Committee determines to have amajor trade impact. The list should include an indication by Members of those internationalstandards, guidelines or recommendations which they apply as conditions for import or onthe basis of which imported products conforming to these standards can enjoy accessto their markets. For those cases in which a Member does not apply an internationalstandard, guideline or recommendation as a condition for import, the Member shouldprovide an indication of the reason therefor, and, in particular, whether it considers thatthe standard is not stringent enough to provide the appropriate level of sanitary orphytosanitary protection. If a Member revises its position, following its indication of theuse of a standard, guideline or recommendation as a condition for import, it shouldprovide an explanation for its change and so inform the Secretariat as well as the relevantinternational organizations, unless such noti cation and explanation is given according

to the procedures of Annex B.5. In order to avoid unnecessary duplication, the Committee may decide, as appropriate, to

use the information generated by the procedures, particularly for noti cation, which arein operation in the relevant international organizations.

6. The Committee may, on the basis of an initiative from one of the Members, throughappropriate channels invite the relevant international organizations or their subsidiarybodies to examine speci c matters with respect to a particular standard, guideline orrecommendation, including the basis of explanations for non-use given according toparagraph 4.

7. The Committee shall review the operation and implementation of this Agreement threeyears after the date of entry into force of the WTO Agreement, and thereafter as theneed arises. Where appropriate, the Committee may submit to the Council for Trade inGoods proposals to amend the text of this Agreement having regard, inter alia, to theexperience gained in its implementation.

Article 13Implementation

1. Members are fully responsible under this Agreement for the observance of all obligationsset forth herein. Members shall formulate and implement positive measures andmechanisms in support of the observance of the provisions of this Agreement by otherthan central government bodies. Members shall take such reasonable measures as maybe available to them to ensure that non-governmental entities within their territories, aswell as regional bodies in which relevant entities within their territories are members,comply with the relevant provisions of this Agreement. In addition, Members shall not take


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measures which have the effect of, directly or indirectly, requiring or encouraging suchregional or non-governmental entities, or local governmental bodies, to act in a mannerinconsistent with the provisions of this Agreement. Members shall ensure that they relyon the services of nongovernmental entities for implementing sanitary or phytosanitarymeasures only if these entities comply with the provisions of this Agreement.

Article 14Final Provisions

1. The least-developed country Members may delay application of the provisions of thisAgreement for a period of ve years following the date of entry into force of the WTOAgreement with respect to their sanitary or phytosanitary measures affecting importation

or imported products. Other developing country Members may delay application of theprovisions of this Agreement, other than paragraph 8 of Article 5 and Article 7, fortwo years following the date of entry into force of the WTO Agreement with respectto their existing sanitary or phytosanitary measures affecting importation or importedproducts, where such application is prevented by a lack of technical expertise, technicalinfrastructure or resources.


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Annex ADe nitions 4

1. Sanitary or phytosanitary measure Any measure applied:

a. to protect animal or plant life or health within the territory of the Member from risks arisingfrom the entry, establishment or spread of pests, diseases, disease-carrying organismsor disease-causing organisms;

b. to protect human or animal life or health within the territory of the Member from risksarising from additives, contaminants, toxins or disease-causing organisms in foods,

beverages or feedstuffs;

c. to protect human life or health within the territory of the Member from risks arising fromdiseases carried by animals, plants or products thereof, or from the entry, establishmentor spread of pests; or

d. to prevent or limit other damage within the territory of the Member from the entry,establishment or spread of pests.

Sanitary or phytosanitary measures include all relevant laws, decrees, regulations,requirements and procedures including, inter alia, end product criteria; processes andproduction methods; testing, inspection, certi cation and approval procedures; quarantinetreatments including relevant requirements associated with the transport of animals or plants,or with the materials necessary for their survival during transport; provisions on relevantstatistical methods, sampling procedures and methods of risk assessment; and packagingand labelling requirements directly related to food safety.

2. Harmonization The establishment, recognition and application of common sanitary

and phytosanitary measures by different Members.

3. International standards, guidelines and recommendations

a. for food safety, the standards, guidelines and recommendations established by the CodexAlimentarius Commission relating to food additives, veterinary drug and pesticide residues,contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;

4. For the purpose of these de nitions, animal includes sh and wild fauna; plant includes forests and wildora; pests include weeds; and contaminants include pesticide and veterinary drug residues and extraneousmatter.


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b. for animal health and zoonoses, the standards, guidelines and recommendations developedunder the auspices of the International Of ce of Epizootics;

c. for plant health, the international standards, guidelines and recommendations developedunder the auspices of the Secretariat of the International Plant Protection Convention incooperation with regional organizations operating within the framework of the InternationalPlant Protection Convention; and

d. for matters not covered by the above organizations, appropriate standards, guidelinesand recommendations promulgated by other relevant international organizations openfor membership to all Members, as identi ed by the Committee.

4. Risk assessment The evaluation of the likelihood of entry, establishment or spreadof a pest or disease within the territory of an importing Member according to the sanitary or

phytosanitary measures which might be applied, and of the associated potential biological andeconomic consequences; or the evaluation of the potential for adverse effects on human oranimal health arising from the presence of additives, contaminants, toxins or disease-causingorganisms in food, beverages or feedstuffs.

5. Appropriate level of sanitary or phytosanitary protection The levelof protection deemed appropriate by the Member establishing a sanitary or phytosanitarymeasure to protect human, animal or plant life or health within its territory.

NOTE: Many Members otherwise refer to this concept as the acceptable level of risk.

6. Pest- or disease-free area An area, whether all of a country, part of a country,or all or parts of several countries, as identi ed by the competent authorities, in which aspeci c pest or disease does not occur.

NOTE: A pest- or disease-free area may surround, be surrounded by, or be adjacent toan area whether within part of a country or in a geographic region which includes parts

of or all of several countries -in which a speci c pest or disease is known to occur but issubject to regional control measures such as the establishment of protection, surveillanceand buffer zones which will con ne or eradicate the pest or disease in question.

7. Area of low pest or disease prevalence An area, whether all of a country,part of a country, or all or parts of several countries, as identi ed by the competent authorities,in which a speci c pest or disease occurs at low levels and which is subject to effectivesurveillance, control or eradication measures.


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Annex BTransparency of sanitary and

phytosanitary regulations

Publication of regulations

1. Members shall ensure that all sanitary and phytosanitary regulations

5

which have beenadopted are published promptly in such a manner as to enable interested Members to becomeacquainted with them.

2. Except in urgent circumstances, Members shall allow a reasonable interval between thepublication of a sanitary or phytosanitary regulation and its entry into force in order to allowtime for producers in exporting Members, and particularly in developing country Members, toadapt their products and methods of production to the requirements of the importing Member.

Enquiry points

3. Each Member shall ensure that one enquiry point exists which is responsible for theprovision of answers to all reasonable questions from interested Members as well as for theprovision of relevant documents regarding:

a. any sanitary or phytosanitary regulations adopted or proposed within its territory;

b. any control and inspection procedures, production and quarantine treatment, pesticidetolerance and food additive approval procedures, which are operated within its territory;

c. risk assessment procedures, factors taken into consideration, as well as the determinationof the appropriate level of sanitary or phytosanitary protection;

d. the membership and participation of the Member, or of relevant bodies within its territory,in international and regional sanitary and phytosanitary organizations and systems, aswell as in bilateral and multilateral agreements and arrangements within the scope ofthis Agreement, and the texts of such agreements and arrangements.

5. Sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable generally.


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4. Members shall ensure that where copies of documents are requested by interestedMembers, they are supplied at the same price (if any), apart from the cost of delivery, as tothe nationals6 of the Member concerned.

Noti cation procedures

5. Whenever an international standard, guideline or recommendation does not exist or thecontent of a proposed sanitary or phytosanitary regulation is not substantially the same asthe content of an international standard, guideline or recommendation, and if the regulationmay have a signi cant effect on trade of other Members, Members shall:

a. publish a notice at an early stage in such a manner as to enable interested Members tobecome acquainted with the proposal to introduce a particular regulation;

b. notify other Members, through the Secretariat, of the products to be covered by theregulation together with a brief indication of the objective and rationale of the proposedregulation. Such noti cations shall take place at an early stage, when amendments canstill be introduced and comments taken into account;

c. provide upon request to other Members copies of the proposed regulation and, wheneverpossible, identify the parts which in substance deviate from international standards,guidelines or recommendations;

d. without discrimination, allow reasonable time for other Members to make comments inwriting, discuss these comments upon request, and take the comments and the resultsof the discussions into account.

6. However, where urgent problems of health protection arise or threaten to arisefor a Member, that Member may omit such of the steps enumerated in paragraph 5of this Annex as it nds necessary, provided that the Member:

a. immediately noti es other Members, through the Secretariat, of the particular regulation

and the products covered, with a brief indication of the objective and the rationale of theregulation, including the nature of the urgent problem(s);

b. provides, upon request, copies of the regulation to other Members;

c. allows other Members to make comments in writing, discusses these comments uponrequest, and takes the comments and the results of the discussions into account.

6. When nationals are referred to in this Agreement, the term shall be deemed, in the case of a separatecustoms territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have areal and effective industrial or commercial establishment in that customs territory.


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7. Noti cations to the Secretariat shall be in English, French or Spanish.

8. Developed country Members shall, if requested by other Members, provide copies of thedocuments or, in case of voluminous documents, summaries of the documents covered bya speci c noti cation in English, French or Spanish.

9. The Secretariat shall promptly circulate copies of the noti cation to all Members andinterested international organizations and draw the attention of developing country Membersto any noti cations relating to products of particular interest to them.

10. Members shall designate a single central government authority as responsible for theimplementation, on the national level, of the provisions concerning noti cation procedures

according to paragraphs 5, 6, 7 and 8 of this Annex.

General reservations

11. Nothing in this Agreement shall be construed as requiring:

a. the provision of particulars or copies of drafts or the publication of texts other than inthe language of the Member except as stated in paragraph 8 of this Annex; or

b. Members to disclose con dential information which would impede enforcement of sanitaryor phytosanitary legislation or which would prejudice the legitimate commercial interestsof particular enterprises.


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Annex CControl, inspection and

approval procedures 7

1. Members shall ensure, with respect to any procedure to check and ensure the ful lmentof sanitary or phytosanitary measures, that:

a. such procedures are undertaken and completed without undue delay and in no lessfavourable manner for imported products than for like domestic products;

b. the standard processing period of each procedure is published or that the anticipatedprocessing period is communicated to the applicant upon request; when receiving anapplication, the competent body promptly examines the completeness of the documentationand informs the applicant in a precise and complete manner of all de ciencies; thecompetent body transmits as soon as possible the results of the procedure in a preciseand complete manner to the applicant so that corrective action may be taken if necessary;even when the application has de ciencies, the competent body proceeds as far aspracticable with the procedure if the applicant so requests; and that upon request, theapplicant is informed of the stage of the procedure, with any delay being explained;

c. information requirements are limited to what is necessary for appropriate control,inspection and approval procedures, including for approval of the use of additives orfor the establishment of tolerances for contaminants in food, beverages or feedstuffs;

d. the con dentiality of information about imported products arising from or supplied in

connection with control, inspection and approval is respected in a way no less favourablethan for domestic products and in such a manner that legitimate commercial interestsare protected;

e. any requirements for control, inspection and approval of individual specimens of a productare limited to what is reasonable and necessary;

7. Control, inspection and approval procedures include, inter alia, procedures for sampling, testing andcerti cation.


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f. any fees imposed for the procedures on imported products are equitable in relation toany fees charged on like domestic products or products originating in any other Memberand should be no higher than the actual cost of the service;

g. the same criteria should be used in the siting of facilities used in the procedures and theselection of samples of imported products as for domestic products so as to minimizethe inconvenience to applicants, importers, exporters or their agents;

h. whenever speci cations of a product are changed subsequent to its control and inspectionin light of the applicable regulations, the procedure for the modi ed product is limitedto what is necessary to determine whether adequate con dence exists that the productstill meets the regulations concerned; and

i. a procedure exists to review complaints concerning the operation of such proceduresand to take corrective action when a complaint is justi ed.

Where an importing Member operates a system for the approval of the use of food additivesor for the establishment of tolerances for contaminants in food, beverages or feedstuffswhich prohibits or restricts access to its domestic markets for products based on the absenceof an approval, the importing Member shall consider the use of a relevant internationalstandard as the