1.Members shall accept the sanitary or phytosanitarymeasures of other Members as equivalent, even if thesemeasures differ from their own or from those used byother Members trading in the same product, if theexporting Member objectively demonstrates to theimporting Member that its measures achieve the importingMember's appropriate level of sanitary or phytosanitaryprotection. For this purpose, reasonable access shall begiven, upon request, to the importing Member forinspection, testing and other relevant procedures.
2.Members shall, upon request, enter into consultationswith the aim of achieving bilateral and multilateralagreements on recognition of the equivalence of specifiedsanitary or phytosanitary measures.
backto topArticle5 Assessment of Risk and Determination of the AppropriateLevel of Sanitary or Phytosanitary Protection1.Members shall ensure that their sanitary or phytosanitarymeasures are based on an assessment, as appropriate tothe circumstances, of the risks to human, animal or plantlife or health, taking into account risk assessmenttechniques developed by the relevant internationalorganizations.
2.In the assessment of risks, Members shall take intoaccount available scientific evidence; relevant processesand production methods; relevant inspection, sampling andtesting methods; prevalence of specific diseases orpests; 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 healthand determining the measure to be applied for achievingthe appropriate level of sanitary or phytosanitaryprotection from such risk, Members shall take intoaccount as relevant economic factors: the potentialdamage in terms of loss of production or sales in theevent of the entry, establishment or spread of a pest ordisease; the costs of control or eradication in theterritory of the importing Member; and the relativecost-effectiveness of alternative approaches to limitingrisks.
4.Members should, when determining the appropriate level ofsanitary or phytosanitary protection, take into accountthe objective of minimizing negative trade effects.
5.With the objective of achieving consistency in theapplication of the concept of appropriate level ofsanitary or phytosanitary protection against risks tohuman life or health, or to animal and plant life orhealth, each Member shall avoid arbitrary orunjustifiable distinctions in the levels it considers tobe appropriate in different situations, if suchdistinctions result in discrimination or a disguisedrestriction on international trade. Members shallcooperate in the Committee, in accordance with paragraphs1, 2 and 3 of Article 12, to develop guidelines tofurther the practical implementation of this provision.In developing the guidelines, the Committee shall takeinto account all relevant factors, including theexceptional character of human health risks to whichpeople voluntarily expose themselves.
6.Without prejudice to paragraph 2 of Article 3, whenestablishing or maintaining sanitary or phytosanitarymeasures to achieve the appropriate level of sanitary orphytosanitary protection, Members shall ensure that suchmeasures are not more trade-restrictive than required toachieve their appropriate level of sanitary orphytosanitary protection, taking into account technicaland economic feasibility.(3)
7.In cases where relevant scientific evidence isinsufficient, a Member may provisionally adopt sanitaryor phytosanitary measures on the basis of availablepertinent information, including that from the relevantinternational organizations as well as from sanitary orphytosanitary measures applied by other Members. In suchcircumstances, Members shall seek to obtain theadditional information necessary for a more objectiveassessment of risk and review the sanitary orphytosanitary measure accordingly within a reasonableperiod of time.
8.When a Member has reason to believe that a specificsanitary or phytosanitary measure introduced ormaintained by another Member is constraining, or has thepotential to constrain, its exports and the measure isnot based on the relevant international standards,guidelines or recommendations, or such standards,guidelines or recommendations do not exist, anexplanation of the reasons for such sanitary orphytosanitary measure may be requested and shall beprovided by the Member maintaining the measure.
backto topArticle6 Adaptation to Regional Conditions, Including Pest or Disease Free Areas and Areas of Low Pest orDisease Prevalence1.Members shall ensure that their sanitary or phytosanitarymeasures are adapted to the sanitary or phytosanitarycharacteristics of the area whether all of acountry, part of a country, or all or parts of severalcountries from which the product originated and towhich the product is destined. In assessing the sanitaryor phytosanitary characteristics of a region, Membersshall take into account, inter alia, the level ofprevalence of specific diseases or pests, the existenceof eradication or control programmes, and appropriatecriteria or guidelines which may be developed by therelevant international organizations.
2.Members shall, in particular, recognize the concepts ofpest or disease-free areas and areas of low pestor disease prevalence. Determination of such areas shallbe based on factors such as geography, ecosystems,epidemiological surveillance, and the effectiveness ofsanitary or phytosanitary controls.
3.Exporting Members claiming that areas within theirterritories are pest or disease-free areas orareas of low pest or disease prevalence shall provide thenecessary evidence thereof in order to objectivelydemonstrate to the importing Member that such areas are,and are likely to remain, pest or diseasefreeareas or areas of low pest or disease prevalence,respectively. For this purpose, reasonable access shallbe given, upon request, to the importing Member forinspection, testing and other relevant procedures.
backto topArticle7 TransparencyMembersshall notify changes in their sanitary or phytosanitarymeasures and shall provide information on their sanitaryor phytosanitary measures in accordance with theprovisions of Annex B.
backto topArticle8 Control, Inspection and Approval ProceduresMembersshall observe the provisions of Annex C in the operationof control, inspection and approval procedures, includingnational systems for approving the use of additives orfor establishing tolerances for contaminants in foods,beverages or feedstuffs, and otherwise ensure that theirprocedures are not inconsistent with the provisions ofthis Agreement.
backto topArticle9 Technical Assistance1.Members agree to facilitate the provision of technicalassistance to other Members, especially developingcountry Members, either bilaterally or through theappropriate international organizations. Such assistancemay be, inter alia, in the areas of processingtechnologies, research and infrastructure, including inthe establishment of national regulatory bodies, and maytake the form of advice, credits, donations and grants,including for the purpose of seeking technical expertise,training and equipment to allow such countries to adjustto, and comply with, sanitary or phytosanitary measuresnecessary to achieve the appropriate level of sanitary orphytosanitary protection in their export markets.
2.Where substantial investments are required in order foran exporting developing country Member to fulfil thesanitary or phytosanitary requirements of an importingMember, the latter shall consider providing suchtechnical assistance as will permit the developingcountry Member to maintain and expand its market accessopportunities for the product involved.
backto topArticle10 Special and Differential Treatment1.In the preparation and application of sanitary orphytosanitary measures, Members shall take account of thespecial needs of developing country Members, and inparticular of the least-developed country Members.
2.Where the appropriate level of sanitary or phytosanitaryprotection allows scope for the phased introduction ofnew sanitary or phytosanitary measures, longertime-frames for compliance should be accorded on productsof interest to developing country Members so as tomaintain opportunities for their exports.
3.With a view to ensuring that developing country Membersare able to comply with the provisions of this Agreement,the Committee is enabled to grant to such countries, uponrequest, specified, time-limited exceptions in whole orin part from obligations under this Agreement, takinginto account their financial, trade and developmentneeds.
4.Members should encourage and facilitate the activeparticipation of developing country Members in therelevant international organizations.
backto topArticle11 Consultations and Dispute Settlement1.The provisions of Articles XXII and XXIII of GATT 1994 aselaborated and applied by the Dispute SettlementUnderstanding shall apply to consultations and thesettlement of disputes under this Agreement, except asotherwise specifically provided herein.
2.In a dispute under this Agreement involving scientific ortechnical issues, a panel should seek advice from expertschosen by the panel in consultation with the parties tothe dispute. To this end, the panel may, when it deems itappropriate, establish an advisory technical expertsgroup, or consult the relevant internationalorganizations, at the request of either party to thedispute or on its own initiative.
3.Nothing in this Agreement shall impair the rights ofMembers under other international agreements, includingthe right to resort to the good offices or disputesettlement mechanisms of other internationalorganizations or established under any internationalagreement.
backto topArticle12 Administration1.A Committee on Sanitary and Phytosanitary Measures ishereby established to provide a regular forum forconsultations. It shall carry out the functions necessaryto implement the provisions of this Agreement and thefurtherance of its objectives, in particular with respectto harmonization. The Committee shall reach its decisionsby consensus.
2.The Committee shall encourage and facilitate ad hocconsultations or negotiations among Members on specificsanitary or phytosanitary issues. The Committee shallencourage the use of international standards, guidelinesor recommendations by all Members and, in this regard,shall sponsor technical consultation and study with theobjective of increasing coordination and integrationbetween international and national systems and approachesfor approving the use of food additives or forestablishing tolerances for contaminants in foods,beverages or feedstuffs.
3.The Committee shall maintain close contact with therelevant international organizations in the field ofsanitary and phytosanitary protection, especially withthe Codex Alimentarius Commission, the InternationalOffice of Epizootics, and the Secretariat of theInternational Plant Protection Convention, with theobjective of securing the best available scientific andtechnical advice for the administration of this Agreementand in order to ensure that unnecessary duplication ofeffort is avoided.
4.The Committee shall develop a procedure to monitor theprocess of international harmonization and the use ofinternational standards, guidelines or recommendations.For this purpose, the Committee should, in conjunctionwith the relevant international organizations, establisha list of international standards, guidelines orrecommendations relating to sanitary or phytosanitarymeasures which the Committee determines to have a majortrade impact. The list should include an indication byMembers of those international standards, guidelines orrecommendations which they apply as conditions for importor on the basis of which imported products conforming tothese standards can enjoy access to their markets. Forthose cases in which a Member does not apply aninternational standard, guideline or recommendation as acondition for import, the Member should provide anindication of the reason therefor, and, in particular,whether it considers that the standard is not stringentenough to provide the appropriate level of sanitary orphytosanitary protection. If a Member revises itsposition, following its indication of the use of astandard, guideline or recommendation as a condition forimport, it should provide an explanation for its changeand so inform the Secretariat as well as the relevantinternational organizations, unless such notification andexplanation is given according to the procedures of AnnexB.
5.In order to avoid unnecessary duplication, the Committeemay decide, as appropriate, to use the informationgenerated by the procedures, particularly fornotification, which are in operation in the relevantinternational organizations.
6.The Committee may, on the basis of an initiative from oneof the Members, through appropriate channels invite therelevant international organizations or their subsidiarybodies to examine specific matters with respect to aparticular standard, guideline or recommendation,including the basis of explanations for non-use givenaccording to paragraph 4.
7.The Committee shall review the operation andimplementation of this Agreement three years after thedate of entry into force of the WTO Agreement, andthereafter as the need arises. Where appropriate, theCommittee may submit to the Council for Trade in Goodsproposals to amend the text of this Agreement havingregard, inter alia, to the experience gained inits implementation.
backto topArticle13 ImplementationMembersare fully responsible under this Agreement for theobservance of all obligations set forth herein. Membersshall formulate and implement positive measures andmechanisms in support of the observance of the provisionsof this Agreement by other than central governmentbodies. Members shall take such reasonable measures asmay be available to them to ensure that non-governmentalentities within their territories, as well as regionalbodies in which relevant entities within theirterritories are members, comply with the relevantprovisions of this Agreement. In addition, Members shallnot take measures which have the effect of, directly orindirectly, requiring or encouraging such regional ornon-governmental entities, or local governmental bodies,to act in a manner inconsistent with the provisions ofthis Agreement. Members shall ensure that they rely onthe services of non-governmental entities forimplementing sanitary or phytosanitary measures only ifthese entities comply with the provisions of thisAgreement.
backto topArticle14 Final ProvisionsTheleast-developed country Members may delay application ofthe provisions of this Agreement for a period of fiveyears following the date of entry into force of the WTOAgreement with respect to their sanitary or phytosanitarymeasures affecting importation or imported products.Other developing country Members may delay application ofthe provisions of this Agreement, other than paragraph 8of Article 5 and Article 7, for two years following thedate of entry into force of the WTO Agreement withrespect to their existing sanitary or phytosanitarymeasures affecting importation or imported products,where such application is prevented by a lack oftechnical expertise, technical infrastructure orresources.
back to topANNEX A DEFINITIONS (4)1.Sanitary or phytosanitary measure Anymeasure applied:
(a)to protect animal or plant life or health within theterritory of the Member from risks arising from theentry, establishment or spread of pests, diseases,disease-carrying organisms or disease-causing organisms;
(b)to protect human or animal life or health within theterritory of the Member from risks arising fromadditives, contaminants, toxins or disease-causingorganisms in foods, beverages or feedstuffs;
(c)to protect human life or health within the territory ofthe Member from risks arising from diseases carried byanimals, plants or products thereof, or from the entry,establishment or spread of pests; or
(d)to prevent or limit other damage within the territory ofthe Member from the entry, establishment or spread ofpests.
Sanitaryor phytosanitary measures include all relevant laws,decrees, regulations, requirements and proceduresincluding, inter alia, end product criteria;processes and production methods; testing, inspection,certification and approval procedures; quarantinetreatments including relevant requirements associatedwith the transport of animals or plants, or with thematerials necessary for their survival during transport;provisions on relevant statistical methods, samplingprocedures and methods of risk assessment; and packagingand labelling requirements directly related to foodsafety.
2.Harmonization The establishment, recognition andapplication of common sanitary and phytosanitary measuresby different Members.
3.International standards, guidelines and recommendations
(a)for food safety, the standards, guidelines andrecommendations established by the Codex AlimentariusCommission relating to food additives, veterinary drugand pesticide residues, contaminants, methods of analysisand sampling, and codes and guidelines of hygienicpractice;
(b)for animal health and zoonoses, the standards, guidelinesand recommendations developed under the auspices of theInternational Office of Epizootics;
(c)for plant health, the international standards, guidelinesand recommendations developed under the auspices of theSecretariat of the International Plant ProtectionConvention in cooperation with regional organizationsoperating within the framework of the International PlantProtection Convention; and
(d)for matters not covered by the above organizations,appropriate standards, guidelines and recommendationspromulgated by other relevant international organizationsopen for membership to all Members, as identified by theCommittee.
4.Risk assessment The evaluation of the likelihoodof entry, establishment or spread of a pest or diseasewithin the territory of an importing Member according tothe sanitary or phytosanitary measures which might beapplied, and of the associated potential biological andeconomic consequences; or the evaluation of the potentialfor adverse effects on human or animal health arisingfrom the presence of additives, contaminants, toxins ordisease-causing organisms in food, beverages orfeedstuffs.
5.Appropriate level of sanitary or phytosanitary protection The level of protection deemed appropriate by theMember establishing a sanitary or phytosanitary measureto protect human, animal or plant life or health withinits territory.
NOTE:Many Members otherwise refer to this concept as theacceptable level of risk.
6.Pest or disease-free area An area, whetherall of a country, part of a country, or all or parts ofseveral countries, as identified by the competentauthorities, in which a specific pest or disease does notoccur.
NOTE:A pest or disease-free area may surround, besurrounded by, or be adjacent to an area whetherwithin part of a country or in a geographic region whichincludes parts of or all of several countries -in which aspecific pest or disease is known to occur but is subjectto regional control measures such as the establishment ofprotection, surveillance and buffer zones which willconfine 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 orparts of several countries, as identified by thecompetent authorities, in which a specific pest ordisease occurs at low levels and which is subject toeffective surveillance, control or eradication measures.
back to topAnnex B Transparency Of Sanitary And Phytosanitary RegulationsPublicationof regulations
1.Members shall ensure that all sanitary and phytosanitaryregulations (5)which have been adopted are published promptly in such amanner as to enable interested Members to becomeacquainted with them.
2.Except in urgent circumstances, Members shall allow areasonable interval between the publication of a sanitaryor phytosanitary regulation and its entry into force inorder to allow time for producers in exporting Members,and particularly in developing country Members, to adapttheir products and methods of production to therequirements of the importing Member.
Enquirypoints
3.Each Member shall ensure that one enquiry point existswhich is responsible for the provision of answers to allreasonable questions from interested Members as well asfor the provision of relevant documents regarding:
(a)any sanitary or phytosanitary regulations adopted orproposed within its territory;
(b)any control and inspection procedures, production andquarantine treatment, pesticide tolerance and foodadditive approval procedures, which are operated withinits territory;
(c)risk assessment procedures, factors taken intoconsideration, as well as the determination of theappropriate level of sanitary or phytosanitaryprotection;
(d)the membership and participation of the Member, or ofrelevant bodies within its territory, in internationaland regional sanitary and phytosanitary organizations andsystems, as well as in bilateral and multilateralagreements and arrangements within the scope of thisAgreement, and the texts of such agreements andarrangements.
4.Members shall ensure that where copies of documents arerequested by interested Members, they are supplied at thesame price (if any), apart from the cost of delivery, asto the nationals (6)of the Member concerned.
Notificationprocedures
5.Whenever an international standard, guideline orrecommendation does not exist or the content of aproposed sanitary or phytosanitary regulation is notsubstantially the same as the content of an internationalstandard, guideline or recommendation, and if theregulation may have a significant effect on trade ofother Members, Members shall:
(a)publish a notice at an early stage in such a manner as toenable interested Members to become acquainted with theproposal to introduce a particular regulation;
(b)notify other Members, through the Secretariat, of theproducts to be covered by the regulation together with abrief indication of the objective and rationale of theproposed regulation. Such notifications shall take placeat an early stage, when amendments can still beintroduced and comments taken into account;
(c)provide upon request to other Members copies of theproposed regulation and, whenever possible, identify theparts which in substance deviate from internationalstandards, guidelines or recommendations;
(d)without discrimination, allow reasonable time for otherMembers to make comments in writing, discuss thesecomments upon request, and take the comments and theresults of the discussions into account.
6.However, where urgent problems of health protection ariseor threaten to arise for a Member, that Member may omitsuch of the steps enumerated in paragraph 5 of this Annexas it finds necessary, provided that the Member:
(a)immediately notifies other Members, through theSecretariat, of the particular regulation and theproducts covered, with a brief indication of theobjective and the rationale of the regulation, includingthe nature of the urgent problem(s);
(b)provides, upon request, copies of the regulation to otherMembers;
(c)allows other Members to make comments in writing,discusses these comments upon request, and takes thecomments and the results of the discussions into account.
7.Notifications to the Secretariat shall be in English,French or Spanish.
8.Developed country Members shall, if requested by otherMembers, provide copies of the documents or, in case ofvoluminous documents, summaries of the documents coveredby a specific notification in English, French or Spanish.
9.The Secretariat shall promptly circulate copies of thenotification to all Members and interested internationalorganizations and draw the attention of developingcountry Members to any notifications relating to productsof particular interest to them.
10.Members shall designate a single central governmentauthority as responsible for the implementation, on thenational level, of the provisions concerning notificationprocedures according to paragraphs 5, 6, 7 and 8 of thisAnnex.
Generalreservations
11.Nothing in this Agreement shall be construed asrequiring:
(a)the provision of particulars or copies of drafts or thepublication of texts other than in the language of theMember except as stated in paragraph 8 of this Annex; or
(b)Members to disclose confidential information which wouldimpede enforcement of sanitary or phytosanitarylegislation or which would prejudice the legitimatecommercial interests of particular enterprises.
backto topANNEX C CONTROL, INSPECTION AND APPROVAL PROCEDURES(7)1.Members shall ensure, with respect to any procedure tocheck and ensure the fulfilment of sanitary orphytosanitary measures, that:
(a)such procedures are undertaken and completed withoutundue delay and in no less favourable manner for importedproducts than for like domestic products;
(b)the standard processing period of each procedure ispublished or that the anticipated processing period iscommunicated to the applicant upon request; whenreceiving an application, the competent body promptlyexamines the completeness of the documentation andinforms the applicant in a precise and complete manner ofall deficiencies; the competent body transmits as soon aspossible the results of the procedure in a precise andcomplete manner to the applicant so that correctiveaction may be taken if necessary; even when theapplication has deficiencies, the competent body proceedsas far as practicable with the procedure if the applicantso requests; and that upon request, the applicant isinformed of the stage of the procedure, with any delaybeing explained;
(c)information requirements are limited to what is necessaryfor appropriate control, inspection and approvalprocedures, including for approval of the use ofadditives or for the establishment of tolerances forcontaminants in food, beverages or feedstuffs;
(d)the confidentiality of information about importedproducts arising from or supplied in connection withcontrol, inspection and approval is respected in a way noless favourable than for domestic products and in such amanner that legitimate commercial interests areprotected;
(e)any requirements for control, inspection and approval ofindividual specimens of a product are limited to what isreasonable and necessary;
(f)any fees imposed for the procedures on imported productsare equitable in relation to any fees charged on likedomestic products or products originating in any otherMember and should be no higher than the actual cost ofthe service;
(g)the same criteria should be used in the siting offacilities used in the procedures and the selection ofsamples of imported products as for domestic products soas to minimize the inconvenience to applicants,importers, exporters or their agents;
(h)whenever specifications of a product are changedsubsequent to its control and inspection in light of theapplicable regulations, the procedure for the modifiedproduct is limited to what is necessary to determinewhether adequate confidence exists that the product stillmeets the regulations concerned; and
(i)a procedure exists to review complaints concerning theoperation of such procedures and to take correctiveaction when a complaint is justified.
Wherean importing Member operates a system for the approval ofthe use of food additives or for the establishment oftolerances for contaminants in food, beverages orfeedstuffs which prohibits or restricts access to itsdomestic markets for products based on the absence of anapproval, the importing Member shall consider the use ofa relevant international standard as the basis for accessuntil a final determination is made.
2.Where a sanitary or phytosanitary measure specifiescontrol at the level of production, the Member in whoseterritory the production takes place shall provide thenecessary assistance to facilitate such control and thework of the controlling authorities.
3.Nothing in this Agreement shall prevent Members fromcarrying out reasonable inspection within their ownterritories.