The texts reproduced here do not have the legal standing of the original documents which are entrusted and kept at the WTO Secretariat in Geneva.

> Preamble
> Article 1
> Article 2
> Article 3
> Article 4
> Article 5
> Article 6
> Article 7
> Article 8
> Article 9
> Article 10
> Article 11
> Article 12
> Article 13
> Relationship with other WTO Agreements
> Annex A
> Annex B
> Annex C

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VII. Article 6     back to top

A. Text of Article 6

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

1.     Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or phytosanitary characteristics of the area — whether all of a country, part of a country, or all or parts of several countries — from which the product originated and to which the product is destined. In assessing the sanitary or phytosanitary characteristics of a region, Members shall take into account, inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control programmes, and appropriate criteria or guidelines which may be developed by the relevant international organizations.

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

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

B. Interpretation and Application of Article 6

175.     In Australia — Salmon, Australia argued that the Panel had exceeded its terms of reference by referring to Article 6.1; Australia claimed that the Panel had made an implicit finding of inconsistency of the Australian measure with Article 6, although the Canadian request for the establishment of a panel had not included a claim under Article 6. The Appellate Body rejected the Australian argument:

“Canada’s request for the establishment of a panel did not include a claim of violation of Article 6 of the SPS Agreement. The Panel’s terms of reference are determined by Canada’s request for the establishment of a panel. We, therefore, agree with Australia that Article 6 of the SPS Agreement is not within the terms of reference of the Panel. However, we disagree with Australia that the Panel exceeded its terms of reference in quoting Article 6.1 in a footnote, attached to a paragraph in which the Panel examined a violation of Article 5.5. More precisely, we reject Australia’s contention that the Panel, by merely referring to Article 6.1 in a footnote, made an implied finding of inconsistency with Article 6. In our view, the statement of the Panel with regard to Article 6, in footnote 430 of its Report, is similar in character to the statement of the panel in United States — Shirts and Blouses, with regard to the powers of the Textile Monitoring Body (‘TMB’). India appealed from this statement, but we found it to be ‘purely a descriptive and gratuitous comment providing background concerning the Panel’s understanding of how the TMB functions’.(224) We did not consider that statement to be ‘a legal finding or conclusion’ which the Appellate Body ‘may uphold, modify or reverse’. Likewise, we consider that in this case, the Panel’s statement in footnote 430 of its Report regarding Article 6.1 of the SPS Agreement is a purely gratuitous comment and not ‘a legal finding or conclusion’. By making such a comment, the Panel did not exceed its terms of reference.”(225)

VIII. Article 7     back to top

A. Text of Article 7

Article 7: Transparency

     Members shall notify changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B.(226)

B. Interpretation and Application of Article 7

1. General

176.     In Japan — Agricultural Products II, the Panel concluded that: “Japan, by not having published the varietal testing requirement, acts inconsistently with its obligations under paragraph 1 of Annex B of the SPS Agreement and, for that reason, with its obligations contained in Article 7 of that Agreement.”(227) The Appellate Body while examining Japan’s appeal on publication requirements under paragraph 1 of Annex B concluded that the varietal testing requirement, as set out in the Experimental Guide, is a phytosanitary regulation within the meaning of paragraph 1 of Annex B, and upheld the Panel’s finding that Japan had acted inconsistently with this provision and hence with Article 7 of the SPS Agreement,(228) see paragraph 225 below.

2. Notification requirements

(a) Recommended notification procedures

177.     At its meeting of 29–30 March 1995, the SPS Committee adopted notification procedures recommended by the informal contact group, subject to certain conditions.(229) At its meeting of 29–30 May 1996, the SPS Committee revised the notification procedures to be followed for notifications required under paragraphs 5 and 6 of Annex B.(230) Further, at its meeting of 10–11 March 1999, the SPS Committee again revised the notification procedures.(231) The last revision of the notification procedures was carried out by the SPS Committee at its meeting of 2 April 2002.(232)

178.     In November 2000, a handbook entitled “how to apply the Transparency Provisions of the SPS Agreement” was prepared by the Secretariat.(233) The handbook was further revised in September 2002. This handbook, which is available in English, French and Spanish, provides guidance on the establishment and operation of notification authorities and enquiry points. The handbook also covers all three areas of transparency: the publication of regulations, notifications, and responding to enquiries.

179.     At its meeting of 26 October 2001, the SPS Committee adopted the following provision relating to the notification of the conclusion of equivalence agreements between Members further to the Decision on Equivalence (see paragraphs 79–92 above):

“The Committee on Sanitary and Phytosanitary Measures shall revise its recommended notification procedures to provide for the notification of the conclusion of agreements between Members which recognize the equivalence of sanitary and phytosanitary measures.(234) Furthermore, the procedures shall reinforce the existing obligation in paragraph 3(d) of Annex B of the Agreement on the Application of Sanitary and Phytosanitary Measures for national Enquiry Points to provide information, upon request, on the participation in any bilateral or multilateral equivalence agreements of the Member concerned.”(235)

(b) “significant effect on trade of other Members”

180.     The notification procedures adopted and revised by the SPS Committee define the term “significant effect on trade of other Members” as follows:

“For the purposes of Annex B, paragraphs 5 and 6 in the SPS Agreement, the concept of ‘significant effect on trade of other Members’ may refer to the effect on trade:

• of one sanitary or phytosanitary regulation only or of various sanitary or phytosanitary regulations in combination;
   
• in a specific product, group of products or products in general; and
   
• between two or more Members (countries).

When assessing whether the sanitary or phytosanitary regulation may have a significant effect on trade, the Member concerned should take into consideration, using relevant information which is available, such elements as the value or other importance of imports in respect of the importing and/or exporting Members concerned, whether from other Members individually or collectively, the potential development of such imports, and difficulties for producers in other Members to comply with the proposed sanitary or phytosanitary regulations. The concept of a significant effect on trade of other Members should include both import-enhancing and importreducing effects on the trade of other Members, as long as such effects are significant.”(236)

3. Reference to Annex B

181.     With respect to Annex B, see Section XVII.B below.

IX. Article 8     back to top

A. Text of Article 8

Article 8: Control, Inspection and Approval Procedures

     Members shall observe the provisions of Annex C(237) in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement.

B. Interpretation and Application of Article 8

No jurisprudence or decision of a competent WTO body.

X. Article 9     back to top

A. Text of Article 9

Article 9: Technical Assistance

1.     Members agree to facilitate the provision of technical assistance to other Members, especially developing country Members, either bilaterally or through the appropriate international organizations. Such assistance may be, inter alia, in the areas of processing technologies, research and infrastructure, including in the establishment of national regulatory 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 measures necessary to achieve the appropriate level of sanitary or phytosanitary protection in their export markets.

2.     Where substantial investments are required in order for an exporting developing country Member to fulfil the sanitary or phytosanitary requirements of an importing Member, the latter shall consider providing such technical assistance as will permit the developing country Member to maintain and expand its market access opportunities for the product involved.

B. Interpretation and Application of Article 9

No jurisprudence or decision of a competent WTO body.

XI. Article 10     back to top

A. Text of Article 10

Article 10: Special and Differential Treatment

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

2.     Where the appropriate level of sanitary or phytosanitary protection allows scope for the phased introduction of new sanitary or phytosanitary measures, longer timeframes for compliance should be accorded on products of interest to developing country Members so as to maintain opportunities for their exports.

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

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

B. Interpretation and Application of article 10

1. General

182.     At the Doha Ministerial Conference, Members resolved to “provide, to the extent possible, the financial and technical assistance necessary to enable least-developed countries to respond adequately to the introduction of any new SPS measures which may have significant negative effects on their trade.”(238)

183.     At the same Ministerial Conference, Members also decided to ensure a level of technical assistance necessary to enable least-developed countries to respond to the special problems they face in implementing the SPS Agreement.(239)

184.     In 2003, the SPS Committee adopted in principle a proposal by Canada to enhance the transparency of special and differential treatment, subject to elaboration of the procedure.(240) Following discussions on this elaboration in the Committee meetings in March and June 2004, at the October meeting, the Committee adopted the elaboration.(241)

2. Article 10.2: “phased introduction of new sanitary and phytosanitary measures”

(a) “longer time frame for compliance”

185.     At the Doha Ministerial Conference, Members adopted a decision in order to establish a time-frame for the gradual introduction of new sanitary and phytosanitary measures:

“Where the appropriate level of sanitary and phytosanitary protection allows scope for the phased introduction of new sanitary and phytosanitary measures, the phrase ‘longer time-frame for compliance’ referred to in Article 10.2 of the Agreement on the Application of Sanitary and Phytosanitary Measures, shall be understood to mean normally a period of not less than 6 months. …”(242)

(b) Impossibility of phased introduction of SPS measures

186.     At the same Ministerial Conference, Members adopted a decision that established a process to be applied in cases where the phased introduction of a new measure may not be possible:

“Where the appropriate level of sanitary and phytosanitary protection does not allow scope for the phased introduction of a new measure, but specific problems are identified by a Member, the Member applying the measure shall upon request enter into consultations with the country with a view to finding a mutually satisfactory solution to the problem while continuing to achieve the importing Member’s appropriate level of protection.”(243)

XII. Article 11     back to top

A. Text of Article 11

Article 11: Consultations and Dispute Settlement

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

2.     In a dispute under this Agreement involving scientific or technical issues, a panel should seek advice from experts chosen by the panel in consultation with the parties to the dispute. To this end, the panel may, when it deems it appropriate, establish an advisory technical experts group, or consult the relevant international organizations, at the request of either party to the dispute or on its own initiative.

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

B. Interpretation and Application of Article 11

1. General

187.     The following table lists the disputes in which panel and/or Appellate Body reports have been adopted where the provisions of the SPS Agreement were invoked:

2. Article 11.2

(a) Appointment of scientific experts advising the panel

(i) Individual experts

188.     In EC — Hormones, the Appellate Body agreed with the Panel’s decision to hear from individual experts rather than to establish an expert review group:(244)

“[I]n disputes involving scientific or technical issues, neither Article 11.2 of the SPS Agreement, nor Article 13 of the DSU prevents panels from consulting with individual experts. Rather, both the SPS Agreement and the DSU leave to the sound discretion of a panel the determination of whether the establishment of an expert review group is necessary or appropriate.”(245)

189.     As regards, ad hoc proceedings for the appointment of individual experts, see paragraph 191 below.

(ii) Expert appointment procedures

190.     The procedures for the selection of scientific experts were described by the Panel on EC — Hormones, paragraphs 6.6–6.7, the Panel on Australia — Salmon, paragraphs 6.2–6.3, the Panel on Japan — Agricultural Products II, paragraph 6.2 and the Panel on Australia — Salmon (Article 21.5 — Canada), paragraph 6.2.

191.     On the procedures followed by the Panel on EC — Hormones in appointing experts, the Appellate Body noted the following:

“The rules and procedures set forth in Appendix 4 of the DSU apply in situations in which expert review groups have been established. However, this is not the situation in this particular case. Consequently, once the panel has decided to request the opinion of individual scientific experts, there is no legal obstacle to the panel drawing up, in consultation with the parties to the dispute, ad hoc rules for those particular proceedings.”(246)

192.     In EC — Hormones, the Panel gave each party the right to nominate one scientific expert:

“The parties were invited to nominate one expert each, not necessarily from the list provided by the Panel. The Panel then selected three additional individuals from the list taking into account the comments of the parties.”(247)

193.     In contrast, in Australia — Salmon, the Panel did not give the parties the right to nominate any expert.(248) Also in Japan — Agricultural Products II and Australia — Salmon (Article 21.5 — Canada), the Panels proceeded in similar fashion.(249)

(iii) Procedures for obtaining advice from scientific experts

194.     The procedures for obtaining advice from scientific experts were described by the Panels on EC — Hormones(250); Australia — Salmon(251); Australia — Salmon (Article 21.5 — Canada)(252) Japan — Agricultural Products II(253); and Japan — Apples.(254)

(iv) Role of scientific experts

195.     In EC — Hormones, with respect to the role of scientific experts, the Panel noted as follows:

“It is of particular importance that we made clear to the experts advising the Panel that we were not seeking a consensus position among the experts but wanted to hear all views.”(255)

(b) Standard of review

196.     In Japan — Agricultural Products II, the Appellate Body stressed that the investigative authority of a panel did not stretch so far as to “make the case for a complaining party”:

“… Article 13 of the DSU and Article 11.2 of the SPS Agreement suggest that panels have a significant investigative authority. However, this authority cannot be used by a panel to rule in favour of a complaining party which has not established a prima facie case of inconsistency based on specific legal claims asserted by it. A panel is entitled to seek information and advice from experts and from any other relevant source it chooses, pursuant to Article 13 of the DSU and, in an SPS case, Article 11.2 of the SPS Agreement, to help it to understand and evaluate the evidence submitted and the arguments made by the parties, but not to make the case for a complaining party.”(256)

XIII. Article 12     back to top

A. Text of Article 12

Article 12: Administration

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

2.     The Committee shall encourage and facilitate ad hoc consultations or negotiations among Members on specific sanitary or phytosanitary issues. The Committee shall encourage the use of international standards, guidelines or recommendations by all Members and, in this regard, shall sponsor technical consultation and study with the objective of increasing coordination and integration between international and national systems and approaches for approving the use of food additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs.

3.     The Committee shall maintain close contact with the relevant international organizations in the field of sanitary and phytosanitary protection, especially with the Codex Alimentarius Commission, the International Office of Epizootics, and the Secretariat of the International Plant Protection Convention, with the objective of securing the best available scientific and technical advice for the administration of this Agreement and in order to ensure that unnecessary duplication of effort is avoided.

4.     The Committee shall develop a procedure to monitor the process of international harmonization and the use of international standards, guidelines or recommendations. For this purpose, the Committee should, in conjunction with the relevant international organizations, establish a list of international standards, guidelines or recommendations relating to sanitary or phytosanitary measures which the Committee determines to have a major trade impact. The list should include an indication by Members of those international standards, guidelines or recommendations which they apply as conditions for import or on the basis of which imported products conforming to these standards can enjoy access to their markets. For those cases in which a Member does not apply an international standard, guideline or recommendation as a condition for import, the Member should provide an indication of the reason therefor, and, in particular, whether it considers that the standard is not stringent enough to provide the appropriate level of sanitary or phytosanitary protection. If a Member revises its position, following its indication of the use of a standard, guideline or recommendation as a condition for import, it should provide an explanation for its change and so inform the Secretariat as well as the relevant international organizations, unless such notification 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 notification, which are in operation in the relevant international organizations.

6.     The Committee may, on the basis of an initiative from one of the Members, through appropriate channels invite the relevant international organizations or their subsidiary bodies to examine specific matters with respect to a particular standard, guideline or recommendation, including the basis of explanations for non-use given according to paragraph 4.

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

B. Interpretation and Application of Article 12

1. General

197.     At its meeting of 19–20 March 1997, the SPS Committee agreed that the Rules of Procedure for meetings of the General Council(257) shall apply mutatis mutandis for its meetings, except as otherwise provided in the Working Procedures.(258)

2. Article 12.3

198.     With reference to paragraph 3, the WTO and the OIE agreed on a cooperation agreement on 4 May 1998.(259)

199.     The list of observers at meetings of the SPS Committee is as follows:

(a) International Intergovernmental Organizations having observer status on a regular basis

• Food and Agriculture Organization (FAO)
   
• FAO International Plant Protection Convention (IPPC)
   
• FAO/WhO Joint Codex Alimentarius Commission (Codex)
   
• International Monetary Fund (IMF)*
   
• International Organization for Standardization (ISO)
   
• International Trade Centre (ITC)
   
• Office international des épizooties (OIE)
   
• United Nations Conference on Trade and Development (UNCTAD)
   
• World Bank*
   
• World Health Organization (WHO)

(b) International Intergovernmental Organizations having observer status on an ad hoc basis

• African, Caribbean and Pacific Group of States (ACP Group)
   
• European Free Trade Association (EFTA)
   
• Inter-American Institute for Agricultural Cooperation (IICA)
   
• Organization for Economic Co-operation and Development (OECD)
   
• Regional International Organization for Plant Protection and Animal Health (OIRSA)
   
• Latin American Economic System (SELA)

(c) International Intergovernmental Organizations whose request is pending

• Asian and Pacific Coconut Community (APCC)
   
• International Vine and Wine Office (OIV)
   
• Convention on Biological Diversity (CBD)

200.     As regards cooperation in accordance with the Decision on Equivalence, see paragraph 91 above.

3. Article 12.4

201.     At its meeting of 15–16 October 1997, the SPS Committee adopted provisional procedures to monitor the use of international standards(260), and also agreed to review the operation of the provisional monitoring procedure 18 months after its implementation, with a view to deciding at that time whether to continue with the same procedure, amend it or develop another one.(261) After agreeing to a number of extensions on the provisional procedure to monitor the use of international standards, at its meeting of 27–28 October 2004, the SPS Committee adopted modifications to the provisional procedure to monitor the use of international standards.(262)

4. Article 12.7

202.     At its meeting on 15–16 October 1997, the SPS Committee agreed on procedures for conducting the review of the implementation and operation of the SPS Agreement.(263)

203.     At the Doha Ministerial Conference, Members adopted a deadline for reviewing the operation and implementation of the SPS Agreement:

“Pursuant to the provisions of Article 12.7 of the Agreement on the Application of Sanitary and Phytosanitary Measures, the Committee on Sanitary and Phytosanitary Measures is instructed to review the operation and implementation of the Agreement on Sanitary and Phytosanitary Measures at least once every four years.”(264)

204.     At its meeting of 22–23 June 2004, the Committee decided on the process for the review of the SPS Agreement. The review is to be conducted by means of open-ended, informal meetings of the Committee and Members will be invited to identify issues for discussion as part of that process.

XIV. Article 13     back to top

A. Text of Article 13

Article 13: Implementation

Members are fully responsible under this Agreement for the observance of all obligations set forth herein. Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of this Agreement by other than central government bodies. Members shall take such reasonable measures as may be available to them to ensure that non-governmental entities within their territories, as well 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 measures which have the effect of, directly or indirectly, requiring or encouraging such regional or nongovernmental entities, or local governmental bodies, to act in a manner inconsistent with the provisions of this Agreement. Members shall ensure that they rely on the services of non-governmental entities for implementing sanitary or phytosanitary measures only if these entities comply with the provisions of this Agreement.

B. Interpretation and Application of Article 13

1. Scope of the SPS Agreement

(a) Measures of a provincial government

205.     In Australia — Salmon (Article 21.5 — Canada), with respect to a measure taken by a provincial government (Tasmania), the Panel held that in the light of Article 13, measures taken by a non-central government body of Australia fell under the scope of the SPS Agreement:

“Article 13 of the SPS Agreement provides unambiguously that: (1) ‘Members are fully responsible under [the SPS] Agreement for the observance of all obligations set forth herein’; and (2) ‘Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of this Agreement by other than central government bodies’. Reading these two obligations together …, we consider that sanitary measures taken by the Government of Tasmania, being an ‘other than central government’ body as recognized by Australia, are subject to the SPS Agreement and fall under the responsibility of Australia as WTO Member when it comes to their observance of SPS obligations”.(265)

XV. Relationship with other WTO Agreements     back to top

A. WTO Agreement

1. Article XVI:4

206.     In coming to the conclusion referred to in paragraph 6 above, the Appellate Body on EC — Hormones also referred to Article XVI:4 of the WTO Agreement:

“Finally, we observe, more generally, that Article XVI.4 of the WTO Agreement stipulates that:

Each Member shall ensure the conformity of its laws, regulations and administrative procedures with its obligations as provided in the annexed Agreements.

Unlike the GATT 1947, the WTO Agreement was accepted definitively by Members, and therefore, there are no longer ‘existing legislation’ exceptions (so-called ‘grandfather rights’)”.(266)

B. TBT Agreement

1. Article 1.5

207.     The Panel on EC — Hormones, referring to Article 1.5 of the TBT Agreement (267), stated that “[s]ince the measures in dispute are sanitary measures, we find that the TBT Agreement is not applicable to this dispute.”(268)

C. GATT 1994

1. Order of analysis

208.     The Panel on EC — Hormones, in a finding not reviewed by the Appellate Body decided that both the SPS Agreement and the GATT 1994 applied to the European Communities’ measure at issue, and then addressed the question of which of the two Agreements to examine first:

“The SPS Agreement specifically addresses the type of measure in dispute. If we were to examine GATT first, we would in any event need to revert to the SPS Agreement: if a violation of GATT were found, we would need to consider whether Article XX(b) could be invoked and would then necessarily need to examine the SPS Agreement; if, on the other hand, no GATT violation were found, we would still need to examine the consistency of the measure with the SPS Agreement since nowhere is consistency with GATT presumed to be consistency with the SPS Agreement. For these reasons, and in order to conduct our consideration of this dispute in the most efficient manner, we shall first examine the claims raised under the SPS Agreement.”(269)

2. Article III and Article XI

209.     In EC — Hormones, exercising judicial economy, the Panel stated: “Since we have found that the EC measures in dispute are inconsistent with the requirements of the SPS Agreement, we see no need to further examine whether the EC measures in dispute are also inconsistent with Articles III or XI of GATT.”(270) Also, in Australia — Salmon, the Panel stated: “Since we have found that the measure in dispute is inconsistent with the requirements of the SPS Agreement, we see no need to further examine whether it is also inconsistent with Article XI of GATT 1994.”(271) The Appellate Body did not address either of these two findings.

3. Article XX(b)

210.     In EC — Hormones, the European Communities submitted that “the ‘substantive’ provisions of the SPS Agreement can only be addressed if recourse is made to GATT Article XX(b), i.e., if, and only if, a violation of another provision of GATT is first established”. The Panel, in a finding not addressed by the Appellate Body, rejected this argument, indicating as follows:

“According to Article 1.1 of the SPS Agreement, two requirements need to be fulfilled for the SPS Agreement to apply: (i) the measure in dispute is a sanitary or phytosanitary measure; and (ii) the measure in dispute may, directly or indirectly, affect international trade. There are no additional requirements. The SPS Agreement contains, in particular, no explicit requirement of a prior violation of a provision of GATT which would govern the applicability of the SPS Agreement, as asserted by the European Communities.”(272)

211.     The Panel on EC — Hormones then added, with respect to the relationship between the SPS Agreement and Article XX(b) of the GATT 1994, that “[m]any provisions of the SPS Agreement impose ‘substantive’ obligations which go significantly beyond and are additional to the requirements for invocation of Article XX(b)”:

“[W]e find the EC claim that the SPS Agreement does not impose ‘substantive’ obligations additional to those already contained in Article XX(b) of GATT not to be persuasive. It is clear that some provisions of the SPS Agreement elaborate on provisions already contained in GATT, in particular Article XX(b). The final preambular paragraph of the SPS Agreement provides, indeed, that the Members desired ‘to elaborate rules for the application of the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b)’. Examples of such rules are, arguably, some of the obligations contained in Article 2 of the SPS Agreement. However, on this basis alone we cannot conclude that the SPS Agreement only applies, as Article XX(b) of GATT does, if, and only if, a prior violation of a GATT provision has been established. Many provisions of the SPS Agreement impose ‘substantive’ obligations which go significantly beyond and are additional to the requirements for invocation of Article XX(b). These obligations are, inter alia, imposed to ‘further the use of harmonized sanitary and phytosanitary measures between Members’(273) and to ‘improve the human health, animal health and phytosanitary situation in all Members’.(274) They are not imposed, as is the case of the obligations imposed by Article XX(b) of GATT, to justify a violation of another GATT obligation (such as a violation of the non-discrimination obligations of Articles I or III).”(275)

212.     The Panel on Australia — Salmon also dealt with the question whether to address first the provisions of the GATT 1994 or those of the SPS Agreement:

“Canada recognizes that the SPS Agreement provides for obligations additional to those contained in GATT 1994, but, nevertheless, first addresses its claim under Article XI of GATT 1994. Australia invokes Article 2.4 of the SPS Agreement, which presumes GATT consistency for measures found to be in conformity with the SPS Agreement, to first address the SPS Agreement. We note, moreover, that (1) the SPS Agreement specifically addresses the type of measure in dispute, and (2) we will in any case need to examine the SPS Agreement, whether or not we find a GATT violation (since GATT consistency is nowhere presumed to constitute consistency with the SPS Agreement). In order to conduct our consideration of this dispute in the most efficient manner, we shall, therefore, first address the claims made by Canada under the SPS Agreement before addressing those put forward under GATT 1994.”(276)

XVI. Annex A     back to top

A. Text of Annex A

Annex A: Definitions(4)

(footnote original) 4 For the purpose of these definitions, “animal” includes fish and wild fauna; “plant” includes forests and wild flora; “pests” include weeds; and “contaminants” include pesticide and veterinary drug residues and extraneous matter.

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 arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms;

(b)     to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or diseasecausing organisms in foods, beverages or feedstuffs;

(c)     to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or 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 and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and 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 Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;

(b)     for animal health and zoonoses, the standards, guidelines and recommendations developed under the auspices of the International Office of Epizootics;

(c)     for plant health, the international standards, guidelines and recommendations developed under the auspices of the Secretariat of the International Plant Protection Convention in cooperation with regional organizations operating within the framework of the International Plant Protection Convention; and

(d)     for matters not covered by the above organizations, appropriate standards, guidelines and recommendations promulgated by other relevant international organizations open for membership to all Members, as identified by the Committee.

4.     Risk assessment — The evaluation of the likelihood of entry, establishment or spread of 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 and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.

5.     Appropriate level of sanitary or phytosanitary protection — The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure 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 identified by the competent authorities, in which a specific pest or disease does not occur.

NOTE: A pest- or disease-free area may surround, be surrounded by, or be adjacent to an area — whether within part of a country or in a geographic region which includes parts of or all of several countries — in which a specific pest or disease is known to occur but is subject to regional control measures such as the establishment of protection, surveillance and buffer zones which will confine 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 identified by the competent authorities, in which a specific pest or disease occurs at low levels and which is subject to effective surveillance, control or eradication measures.

B. Interpretation and Application of annex A

1. Relationship between paragraph 1(a) and 1(b) of Annex A

213.     In Australia — Salmon, the Panel examined whether an Australian prohibition on imports of dead salmon was a “sanitary measure” within the meaning of paragraph 1(b) of Annex A of the SPS Agreement. While the definition in paragraph 1(a) of Annex A focuses on measures intended to protect animal or plant life or health from risks arising as a result of pests and diseases, paragraph 1(b) speaks of measures intended to protect human or animal life or health from diseasecausing organisms contained in food, beverages or feedstuffs. The Panel held:

“In the circumstances at hand, we consider that the definition of a ‘sanitary measure’ in paragraph 1(a) encompasses the coverage sought by Australia under the definition in paragraph 1(b). The definition in paragraph 1(a) deals with risks arising from ‘the entry, establishment or spread of pests, diseases … or disease-causing organisms’ in general. In the context of disease-causing organisms, the definition in paragraph 1(b) is limited in the sense that it only addresses risks arising from ‘disease-causing organisms in foods, beverages or feedstuffs’ (hereafter also referred to as food-borne risks). We are of the view that, even though both definitions of a ‘sanitary measure’ invoked by Australia might be applicable to the measure in dispute, the objectives for which that measure is being applied are more appropriately covered by the definition in paragraph 1(a). These objectives have been clearly expressed by Australia on several occasions.”(277)

214.     With respect to the two definitions of risk assessment under paragraph 4, see Section XVI.B.2 below.

2.     Paragraph 4: “risk assessment”

(a) General

215.     The Panel on Australia — Salmon (Article 21.5 — Canada) rejected the interpretation of “risk assessment” put forward by Canada, the complaining party. The Panel held that a requirement that Members assess risk “according to the [sanitary] measures which might be applied” could not be read into the definition of “risk assessment”; rather, the requirement of a linkage between the risk assessment on the one hand, and the final measure and the necessity to use such measure on the other, were to be derived from other provisions of the SPS Agreement:

“Canada’s claim … raises the question of whether the definition of risk assessment as such, requiring Members to assess risk ‘according to the [sanitary] measures which might be applied’, can be construed so as to include the obligation to make the link between the assessment, the measures finally selected and the necessity to use these measures in order to achieve the [appropriate level of sanitary or phytosanitary protection]. We find it difficult to read such a requirement into paragraph 4 of Annex A.

In our view, the rights and obligations in respect of these linkages are set out not in the definition of risk assessment itself — which logically precedes the selection of measures — but, inter alia, in the obligation to base sanitary measures on a risk assessment in Article 5.1 and to ensure that sanitary measures are not more trade-restrictive than required to achieve the [appropriate level of sanitary or phytosanitary protection] in the sense of Article 5.6. To examine these questions of relationship between the risk assessment, the measures selected and the [appropriate level of sanitary or phytosanitary protection] under the definition of risk assessment — as Canada … seem[s] to do — would, in our view, run the risk of adding to or diminishing the more specific rights and obligations of Members set out in other SPS obligations, contrary to Article 19.2 of the DSU.

… In any event, we prefer to address this question of relationship between the measures selected and the risk assessment under the obligation to base measures on a risk assessment pursuant to Article 5.1 rather than under the very definition of risk assessment referred to in the same provision.”(278)

(b) First part of paragraph 4: First definition of risk assessment

(i) Types of risks

216.     Referring to the first of the two definitions of “risk assessment” in paragraph 4 of Annex A, the Panel on Australia — Salmon in a finding with which the Appellate Body later expressly agreed(279), considered the two types of risk contained therein:

“Examining the definition of risk assessment applicable to the measure at issue, i.e., the ‘evaluation of the likelihood of entry, establishment or spread of 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 and economic consequences’, we consider, first of all, that the risk thus to be assessed includes (1) the risk of ‘entry, establishment or spread’ of a disease and (2) the risk of the ‘associated potential biological and economic consequences’. When we refer hereafter to the risk related to a disease, this risk thus includes the risk of entry, establishment or spread of that disease as well as the biological and economic consequences associated therewith.

…

In this dispute, the measure at issue is intended to protect animal health as a sanitary measure defined in paragraph 1(a) of Annex A and is to be based on a risk assessment in the sense of the first definition in paragraph 4 of Annex A. According to this first definition in paragraph 4, such risk assessment has to take into account risks arising not only from the ‘entry, establishment or spread of a pest or disease’, but also from the ‘associated biological and economic consequences’.”(280)

(ii) Elements of a “risk assessment”

217.     On the three aspects of a risk assessment, see paragraph 103 above.

(iii) Identifying risk on a disease-specific basis

218.     The Panel on Australia — Salmon stated that where several diseases were involved in the risk assessment, such risk assessment at least had to identify risk on a disease-specific basis. The Panel also referred to the Appellate Body’s findings in EC — Hormones:

“[G]iven the definition of risk assessment applicable in this case (the ‘evaluation of the likelihood of entry, establishment or spread of a … disease’, in the singular form), a risk assessment for the measure at issue in this dispute at least has to identify risk on a disease specific basis, i.e., it has to identify the risk for any given disease of concern separately, not simply address the overall risk related to the combination of all diseases of concern. … The experts advising the Panel on this issue confirmed this. In the EC — Hormones case as well, both the panels and the Appellate Body required some degree of specificity for a risk assessment — or a study or report allegedly part thereof — to be in accordance with the requirements imposed in Article 5.1.”(281)

(iv) “likelihood”

219.     In Australia — Salmon, the Appellate Body recalled its finding in EC — Hormones where it had distinguished between the terms “potential” and “probability”. Finding that the term “likelihood” was synonymous with the term “probability”, the Appellate Body disagreed with the Panel’s finding that a risk assessment required only some evaluation of likelihood or probability:

“We note that the first definition in paragraph 4 of Annex A speaks about the evaluation of ‘likelihood.’ In our report in European Communities — Hormones, we referred to the dictionary meaning of ‘probability’ as ‘degrees of likelihood’ and ‘a thing that is judged likely to be true’, for the purpose of distinguishing the terms ‘potential’ and ‘probability’. For the present purpose, we refer in the same manner to the ordinary meaning of ‘likelihood’, and we consider that it has the same meaning as ‘probability’. On this basis, as well as on the basis of the definition of ‘risk’ and ‘risk assessment’ developed by the Office international des épizooties (‘OIE’) and the OIE Guidelines for Risk Assessment, we maintain that for a risk assessment to fall within the meaning of Article 5.1 and the first definition in paragraph 4 of Annex A, it is not sufficient that a risk assessment conclude that there is a possibility of entry, establishment or spread of diseases and associated biological and economic consequences. A proper risk assessment of this type must evaluate the ‘likelihood’, i.e., the ‘probability’, of entry, establishment or spread of diseases and associated biological and economic consequences as well as the ‘likelihood’, i.e., ‘probability’, of entry, establishment or spread of diseases according to the SPS measures which might be applied.

We note that, although the Panel stated that the definition of a risk assessment for this type of measure requires an ‘evaluation of the likelihood’, for the purpose of satisfying the second and third requirements, it subsequently was hesitant in applying these requirements, by stating or suggesting in paragraphs 8.80, 8.83, 8.89 and 8.91, that some evaluation of the likelihood or probability would suffice. We consider this hesitation unfortunate. We do not agree with the Panel that a risk assessment of this type needs only some evaluation of the likelihood or probability. The definition of this type of risk assessment in paragraph 4 of Annex A refers to ‘the evaluation of the likelihood’ and not to some evaluation of the likelihood. We agree, however, with the Panel’s statements in paragraph 8.80 that the SPS Agreement does not require that the evaluation of the likelihood needs to be done quantitatively. The likelihood may be expressed either quantitatively or qualitatively. Furthermore, we recall, as does the Panel, that we stated in European Communities — Hormones that there is no requirement for a risk assessment to establish a certain magnitude or threshold level of degree of risk.”(282)

219bis.     The Panel in Japan — Apples recalled the Appellate Body’s finding in EC — Hormones that the evaluation of likelihood involves more than a mere identification of ‘possibilities’ and requires an assessment of probability of entry, which implies a higher degree or a ‘threshold of potentiality or possibility’. The Panel further added that such probability need not be expressed in quantitative terms, but may be expressed in qualitative terms.(283)

(v) “according to … which might be applied”

220.     Regarding the requirement to evaluate the likelihood of entry, establishment or spread of the diseases according to the SPS measures which might be applied, the Appellate Body on Japan — Apples agreed with the Panel and found that the phrase “according to the … which might be applied” implies that a risk assessment should not be limited to an examination of the measure already in place:

“[A]ccording to the Panel, the terms in the definition of ‘risk assessment’ set out in paragraph 4 of Annex A to the SPS Agreement — more specifically, the phrase ‘according to the sanitary or phytosanitary measures which might be applied’ — suggest that ‘consideration should be given not just to those specific measures which are currently in application, but at least to a potential range of relevant measures.’(284) …

The definition of ‘risk assessment’ in the SPS Agreement requires that the evaluation of the entry, establishment or spread of a disease be conducted ‘according to the sanitary or phytosanitary measure which might be applied.’ We agree with the Panel that this phrase ‘refers to the measures which might be applied, not merely to the measures which are being applied.’(285) The phrase ‘which might be applied’ is used in the conditional tense. In this sense, ‘might’ means: ‘were or would be or have been able to, were or would be or have been allowed to, were or would perhaps’.(286) We understand this phrase to imply that a risk assessment should not be limited to an examination of the measure already in place or favoured by the importing Member. In other words, the evaluation contemplated in paragraph 4 of Annex A to the SPS Agreement should not be distorted by preconditioned views on the nature and the content of the measure to be taken; nor should it develop into an exercise tailored to and carried out for the purpose of justifying decisions ex post facto.”(287)

(vi) “Evaluation of likelihood of entry, establishment or spread of a pest or disease …”

221.     In Japan — Apples, the Appellate Body upheld the Panel’s finding that Japan’s risk assessment did not evaluate the likelihood of entry, establishment or spread of fire blight because its risk assessment was not specific enough about the product at issue — apple fruit:

“[U]nder the SPS Agreement, the obligation to conduct an assessment of ‘risk’ is not satisfied merely by a general discussion of the disease sought to be avoided by the imposition of a phytosanitary measure.(288) The Appellate Body found the risk assessment at issue in EC — Hormones not to be ‘sufficiently specific’ even though the scientific articles cited by the importing Member had evaluated the ‘carcinogenic potential of entire categories of hormones, or of the hormones at issue in general.’(289) In order to constitute a ‘risk assessment’ as defined in the SPS Agreement, the Appellate Body concluded, the risk assessment should have reviewed the carcinogenic potential, not of the relevant hormones in general, but of ‘residues of those hormones found in meat derived from cattle to which the hormones had been administered for growth promotion purposes’.(290) Therefore, when discussing the risk to be specified in the risk assessment in EC — Hormone, the Appellate Body referred in general to the harm concerned (cancer or genetic damage) as well as to the precise agent that may possibly cause the harm (that is, the specific hormones when used in a specific manner and for specific purposes).

In this case, the Panel found that the conclusion of the 1999 PRA with respect to fire blight was ‘based on an overall assessment of possible modes of contamination, where apple fruit is only one of the possible hosts/vectors considered.’(291) … Given that the measure at issue relates to the risk of transmission of fire blight through apple fruit, in an evaluation of whether the risk assessment is ‘sufficiently specific to the case at hand’(292), the nature of the risk addressed by the measure at issue is a factor to be taken into account. In light of these considerations, we are of the view that the Panel properly determined that the 1999 PRA ‘evaluat[ion of] the risks associated with all possible hosts taken together’(293) was not sufficiently specific to qualify as a ‘risk assessment’ under the SPS Agreement for the evaluation of the likelihood of entry, establishment or spread of fire blight in Japan through apple fruit.”(294)

(c) Second part of paragraph 4: Second definition of risk assessment

(i) General

222.     With respect to the second definition of “risk assessment” contained in paragraph 4 of Annex A, the Appellate Body on Australia — Salmon noted that while the first definition speaks of “likelihood”, the second definition speaks of “potential” for adverse effects:

“We note that the first type of risk assessment in paragraph 4 of Annex A is substantially different from the second type of risk assessment contained in the same paragraph. While the second requires only the evaluation of the potential for adverse effects on human or animal health, the first type of risk assessment demands an evaluation of the likelihood of entry, establishment or spread of a disease, and of the associated potential biological and economic consequences. In view of the very different language used in paragraph 4 of Annex A for the two types of risk assessment, we do not believe that it is correct to diminish the substantial differences between these two types of risk assessments, as the European Communities seems to suggest when it argues that ‘the object, purpose and context of the SPS Agreement indicate that no greater level of probability can have been intended for the first type of risk assessment than for the second type, [as b]oth types can apply both to human life or health and to animal or plant life or health’. (Third participant’s submission of the European Communities, para. 7).”(295)

(ii) Methodology of risk assessment

223.     In EC — Hormones, with respect to the methodology for a risk assessment under the second definition of paragraph 4 of Annex A of the SPS Agreement, the Panels stated that “in this dispute, a risk assessment carried out in accordance with the SPS Agreement should (i) identify the adverse effects on human health (if any) arising from the presence of the hormones at issue when used as growth promoters in meat or meat products, and (ii) if any such adverse effects exist, evaluate the potential or probability of occurrence of these effects”.(296) The Appellate Body did not disagree with the Panels’ finding but cautioned against equating the terms “potential” and “probability”:

“Although the utility of a two-step analysis may be debated, it does not appear to us to be substantially wrong. What needs to be pointed out at this stage is that the Panel’s use of ‘probability’ as an alternative term for ‘potential’ creates a significant concern. The ordinary meaning of ‘potential’ relates to ‘possibility’ and is different from the ordinary meaning of ‘probability’. ‘Probability’ implies a higher degree or a threshold of potentiality or possibility. It thus appears that here the Panel introduces a quantitative dimension to the notion of risk.”(297)

224.     While the Appellate Body on Japan — Apples agreed with Japan that whether to analyse the risk on the basis of the particular pest or disease, or on the basis of a particular commodity, is a “matter of methodology” that lies within the discretion of the importing Member, it found that the Panel’s reading of EC — Hormones did not suggest, as Japan had argued, that there was an obligation to follow any particular methodology in conducting a risk assessment. The Appellate Body further elaborated that Members are free to consider in their risk analysis multiple agents in relation to one disease, provided that the risk assessment attributes a likelihood of entry, establishment or spread of the disease to each agent specifically:

“Japan contends that the ‘methodology’ of the risk assessment is not directly addressed by the SPS Agreement. In particular, Japan suggests that, whether to analyze the risk on the basis of the particular pest or disease, or on the basis of a particular commodity, is a ‘matter of methodology’ not directly addressed by the SPS Agreement.(298) We agree. Contrary to Japan’s submission, however, the Panel’s reading of EC — Hormones does not suggest that there is an obligation to follow any particular methodology for conducting a risk assessment. In other words, even though, in a given context, a risk assessment must consider a specific agent or pathway through which contamination might occur, Members are not precluded from organizing their risk assessments along the lines of the disease or pest at issue, or of the commodity to be imported. Thus, Members are free to consider in their risk analysis multiple agents in relation to one disease, provided that the risk assessment attribute a likelihood of entry, establishment or spread of the disease to each agent specifically. Members are also free to follow the other ‘methodology’ identified by Japan and focus on a particular commodity, subject to the same proviso.”(299)

XVII. Annex B     back to top

A. Text of Annex B

Annex B: Transparency of sanitary and phytosanitary regulations

Publication of regulations

1.     Members shall ensure that all sanitary and phytosanitary regulations(5) which have been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them.

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

2.     Except in urgent circumstances, Members shall allow a reasonable interval between the publication of a sanitary or phytosanitary regulation and its entry into force in order to allow time for producers in exporting Members, and particularly in developing country Members, to adapt 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 the provision of answers to all reasonable questions from interested Members as well as for the provision 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, pesticide tolerance and food additive approval procedures, which are operated within its territory;

(c)     risk assessment procedures, factors taken into consideration, as well as the determination of 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, as well as in bilateral and multilateral agreements and arrangements within the scope of this Agreement, and the texts of such agreements and arrangements.

4.     Members shall ensure that where copies of documents are requested by interested Members, they are supplied at the same price (if any), apart from the cost of delivery, as to the nationals(6) of the Member concerned.

(footnote original) 6 When “nationals” are referred to in this Agreement, the term shall be deemed, in the case of a separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory.

Notification procedures

5.     Whenever an international standard, guideline or recommendation does not exist or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation, and if the regulation may have a significant 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 to become acquainted with the proposal to introduce a particular regulation;

(b)     notify other Members, through the Secretariat, of the products to be covered by the regulation together with a brief indication of the objective and rationale of the proposed regulation. Such notifications shall take place at an early stage, when amendments can still be introduced and comments taken into account;

(c)     provide upon request to other Members copies of the proposed regulation and, whenever possible, 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 in writing, discuss these comments upon request, and take the comments and the results of the discussions into account.

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

(a)     immediately notifies other Members, through the Secretariat, of the particular regulation and the products covered, with a brief indication of the objective and the rationale of the regulation, 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 upon request, and takes the comments 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 other Members, provide copies of the documents or, in case of voluminous documents, summaries of the documents covered by a specific notification in English, French or Spanish.

9.     The Secretariat shall promptly circulate copies of the notification to all Members and interested international organizations and draw the attention of developing country Members to any notifications relating to products of particular interest to them.

10.     Members shall designate a single central government authority as responsible for the implementation, on the national level, of the provisions concerning notification 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 in the language of the Member except as stated in paragraph 8 of this Annex; or

(b)     Members to disclose confidential information which would impede enforcement of sanitary or phytosanitary legislation or which would prejudice the legitimate commercial interests of particular enterprises.

B. Interpretation and Application of annex B

1. Paragraphs 1 and 2: Publication requirements

225.     In Japan — Agricultural Products II, with reference to the footnote to paragraph 1 of Annex B, the Appellate Body held that the list of instruments contained therein was not exhaustive in nature and referred to the object and purpose of paragraph 1 of Annex B:

“We consider that the list of instruments contained in the footnote to paragraph 1 of Annex B is, as is indicated by the words ‘such as’, not exhaustive in nature. The scope of application of the publication requirement is not limited to ‘laws, decrees or ordinances’, but also includes, in our opinion, other instruments which are applicable generally and are similar in character to the instruments explicitly referred to in the illustrative list of the footnote to paragraph 1 of Annex B.

The object and purpose of paragraph 1 of Annex B is ‘to enable interested Members to become acquainted with’ the sanitary and phytosanitary regulations adopted or maintained by other Members and thus to enhance transparency regarding these measures. In our opinion, the scope of application of the publication requirement of paragraph 1 of Annex B should be interpreted in the light of the object and purpose of this provision.

We note that it is undisputed that the varietal testing requirement is applicable generally. Furthermore, we consider in the light of the actual impact of the varietal testing requirement on exporting countries, as discussed by the Panel in paragraphs 8.112 and 8.113 of the Panel Report, that this instrument is of a character similar to laws, decrees and ordinances, the instruments explicitly referred to in the footnote to paragraph 1 of Annex B.”(300)

2. Paragraph 2: “reasonable interval”

226.     At the Doha Ministerial conference, Members decided that the “reasonable interval” in respect of paragraph 2 should normally be understood as a period of not less than six months:

“Subject to the conditions specified in paragraph 2 of Annex B to the Agreement on the Application of Sanitary and Phytosanitary Measures, the phrase ‘reasonable interval’ shall be understood to mean normally a period of not less than 6 months. It is understood that timeframes for specific measures have to be considered in the context of the particular circumstances of the measure and actions necessary to implement it. The entry into force of measures which contribute to the liberalization of trade should not be unnecessarily delayed.”(301)

3. Paragraph 3: Enquiry points

227.     The Panel on Australia — Salmon found that there was no obligation under the SPS Agreement for a Member to positively identify its chosen appropriate level of protection. In the context of this finding, the Panel held that paragraph 3 of Annex B did not impose a “substantive obligation on Members to identify or quantify their appropriate level of protection”, but rather merely a “mainly procedural obligation to provide ‘answers to all reasonable questions from all interested Members’”.(302) The Appellate Body reversed the Panel’s finding and held that there was such an — albeit implicit — obligation, inter alia, in paragraph 3 of Annex B.(303)

(a) Paragraph 3(d)

228.     In relation to the reinforcement of the transparency obligation of the agreements on equivalence between Members, see paragraph 179 above.

4. Paragraph 5: Conditions for notification requirements

229.     The Panel on Japan — Apples found that, in determining whether any changes in Members’ SPS measures constitute changes that must be notified under Article 7, the most important factor is “whether the change affects the conditions of market access for the product concerned, that is, would the exported product still be permitted to enter [the market (Japan in this case)] if they complied with the prescription contained in the previous regulations(304)” under the chapeau of paragraph 5 of Annex B. The Panel considered that if that was not the case, then they should decide whether the change could be considered to potentially have a significant effect on the trade of other Members. In this connection, the Panel further held that the party making an allegation must establish a prima facie case by specifying, through sufficient evidence, in what respect any changes in SPS regulations departed from previous ones:

“It is not disputed that the present situation is one where ‘an international standard, guideline or recommendation does not exist [regarding E. amylovora] or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation’. Therefore, we must determine whether the changes identified above constitute changes which are required to be notified under Article 7 because, inter alia, they ‘may have a significant effect on trade of other Members’ in the context of the chapeau to Paragraph 5 of Annex B.

We consider that the most important factor in this regard is whether the change affects the conditions of market access for the product concerned, that is, would the exported product (apple fruit from the United States in this case) still be permitted to enter Japan if they complied with the prescription contained in the previous regulations.(305) If this is not the case, then we must consider whether the change could be considered to potentially have a significant effect on trade of other Members. In this regard, it would be relevant to consider whether the change has resulted in any increase in production, packaging and sales costs, such as more onerous treatment requirements or more time-consuming administrative formalities.

… We recall that, in EC — Hormones, the Appellate Body noted that 

‘… Panels are inhibited from addressing legal claims falling outside their terms of reference. However, nothing in the DSU limits the faculty of a panel freely to use arguments submitted by any of the parties — or to develop its own legal reasoning — to support its own findings and conclusions on the matter under its consideration.’

However, the Appellate Body clarified in Korea — Dairy that ‘[B]oth “claims” and “arguments” are distinct from the “evidence” which the complainant or respondent presents to support its assertions of facts and arguments’.(306) We note in this regard that the party making an allegation must provide sufficient evidence in support of this allegation, and that a panel should not entertain a claim for which a prima facie case has not been made.(307) In the present case, the United States has effectively argued that Japan had substantially changed its fire blight measures since the entry into force of the SPS Agreement. However, the United States limited its argumentation to mention that new regulations had been implemented and to attach translations of the regulations to its first written submission. It did not specify in what respect these new regulations departed from the previous ones.

Indeed, either the United States knows in which respect the 1997 texts differ from the ones they replace — in which case it could and should have mentioned it in its submissions — or it does not, in which case it cannot be deemed to have established a prima facie case. In either situation, for the Panel to examine the regulations at issue to identify differences would be equivalent to ‘making a case’ for the United States, something we are not allowed to do. For these reasons we conclude that the United States did not establish a prima facie case in relation to the violation of Article 7 and Annex B of the SPS Agreement.”(308)

XVIII. Annex C     back to top

A. Text of Annex C

Annex C: Control, inspection and approval procedures(7)

(footnote original) 7 Control, inspection and approval procedures include, inter alia, procedures for sampling, testing and certification.

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

(a)     such procedures are undertaken and completed without undue delay and in no less favourable manner for imported products than for like domestic products;

(b)     the standard processing period of each procedure is published or that the anticipated processing period is communicated to the applicant upon request; when receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all deficiencies; the competent body transmits as soon as possible the results of the procedure in a precise and complete manner to the applicant so that corrective action may be taken if necessary; even when the application has deficiencies, the competent body proceeds as far as practicable with the procedure if the applicant so requests; and that upon request, the applicant 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 or for the establishment of tolerances for contaminants in food, beverages or feedstuffs;

(d)     the confidentiality of information about imported products arising from or supplied in connection with control, inspection and approval is respected in a way no less favourable than for domestic products and in such a manner that legitimate commercial interests are protected;

(e)     any requirements for control, inspection and approval of individual specimens of a product are limited to what is reasonable and necessary;

(f)     any fees imposed for the procedures on imported products are equitable in relation to any fees charged on like domestic products or products originating in any other Member and 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 the selection of samples of imported products as for domestic products so as to minimize the inconvenience to applicants, importers, exporters or their agents;

(h)     whenever specifications of a product are changed subsequent to its control and inspection in light of the applicable regulations, the procedure for the modified product is limited to what is necessary to determine whether adequate confidence exists that the product still meets the regulations concerned; and

(i)     a procedure exists to review complaints concerning the operation of such procedures and to take corrective action when a complaint is justified.

Where an importing Member operates a system for the approval of the use of food additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs which prohibits or restricts access to its domestic markets for products based on the absence of an approval, the importing Member shall consider the use of a relevant international standard as the basis for access until a final determination is made.

2.     Where a sanitary or phytosanitary measure specifies control at the level of production, the Member in whose territory the production takes place shall provide the necessary assistance to facilitate such control and the work of the controlling authorities.

3.     Nothing in this Agreement shall prevent Members from carrying out reasonable inspection within their own territories.

B. Interpretation and Application of Annex C

1. Paragraph 1(c)

230.     In Australia — Salmon (Article 21.5 — Canada), Canada claimed a violation of paragraph 1(c) of Annex C by Australia. The Panel noted that only “procedures to check and ensure the fulfilment of sanitary or phytosanitary measures” fall under the scope of paragraph 1(c) of Annex C. It also considered that the Australian requirements referred to by Canada were “substantive sanitary measures in their own right” and not “procedures to check and ensure the fulfilment of sanitary or phytosanitary measures”. The Panel thus concluded that no violation of paragraph 1(c) could be found.(309)

Footnotes:

224. (footnote original) Appellate Body Report on US — Wool Shirts and Blouses, p. 17. back to text
225. Appellate Body Report on Australia — Salmon, para. 110. back to text
226. See Section XVII. back to text
227. Panel Report on Japan — Agricultural Products II, para. 8.116. back to text
228. Appellate Body Report on Japan — Agricultural Products II, para. 108. back to text
229. G/SPS/R/1, paras. 8–11. The recommended procedures can be found in PC/IPL/6. back to text
230. G/SPS/R/5, para. 16. The revised procedures can be found in G/SPS/7. back to text
231. G/SPS/7/Rev.1, preamble. The revised procedures can be found in G/SPS/7/Rev.1. back to text
232. G/SPS/7/Rev.2 and G/SPS/7/Rev.2/Add.1. back to text
233. This handbook is publicly available on the WTO website (www. wto.org). back to text
234. (footnote original) G/SPS/7/Rev.1. back to text
235. G/SPS/19, para. 11. back to text
236. G/SPS/7, section 7, as revised. back to text
237. See Section XVIII. back to text
238. WT/MIN(01)/17, para. 3.6 (i). back to text
239. WT/MIN(01)/17, para. 3.6 (ii). back to text
240. G/SPS/W/127. back to text
241. G/SPS/33. back to text
242. WT/MIN(01)/17, para. 3.1. back to text
243. WT/MIN(01)/17, para. 3.1. back to text
244. Panel Report on EC — Hormones (Canada), para. 8.7. See also the Panel Report on EC — Hormones (US), para. 8.7. back to text
245. Appellate Body Report on EC — Hormones, para. 147. back to text
246. Appellate Body Report on EC — Hormones, para. 148. back to text
247. Panel Report on EC — Hormones (US), para. 8.8. back to text
248. See Panel Report on Australia — Salmon, para. 6.3. back to text
249. See Panel Reports on Japan — Agricultural Products II, para. 6.3, and Australia — Salmon (Article 21.5 — Canada), para. 6.2. back to text
250. Panel Report on EC — Hormone (US), paras. 8.8–8.9. back to text
251. Panel Report on Australia — Salmon, paras. 6.4–6.5. back to text
252. Panel Report on Australia — Salmon (Article 21.5 — Canada), paras. 6.3–6.4. back to text
253. Panel Report on Japan — Agricultural Products II, paras. 6.2–6.3. back to text
254. Panel Report on Japan — Apples, paras. 6.2–6.4. back to text
255. Panel Report on EC — Hormones (Canada), para. 8.9; Panel Report on EC — Hormones (US), para. 8.9. back to text
256. Appellate Body Report on Japan — Agricultural Products II, paras. 126 and 129. back to text
257. WT/L/161. back to text
258. G/L/170. back to text
259. WT/L/272. This Agreement has been approved by the SPS Committee at its meeting of 1–2 July 1997 (G/SPS/R/8), and subsequently by the Council for Trade in Goods at its meeting of 21 July 1997 (G/C/M/22) and the General Council at its meeting of 22 October 1997 (WT/GC/M/23). 
    * Observer status in WTO subsidiary bodies provided through the WTO Agreements with the Fund and the World Bank (WT/L/194 and WT/L/195). back to text
260. G/SPS/11. At its meeting of 8 July 1999, the Committee adopted the First Annual Report on the monitoring procedure. G/SPS/13. The Sixth Annual Report on the Procedure to Monitor the Process of International harmonization was adopted by the Committee in June 2004. back to text
261. G/SPS/R/9/Rev.1, para. 21. The text of the procedures can be found in G/SPS/11. back to text
262. G/SPS/11/Rev.1. back to text
263. G/SPS/R/9/Rev.1, paras. 35–37. The procedures can be found in G/SPS/10. back to text
264. WT/MIN(01)/17, para. 3.4. back to text
265. Panel Report on Australia — Salmon (Article 21.5 — Canada), para. 7.13. back to text
266. Appellate Body Report on EC — Hormones paras. 128–129. back to text
267. Article 1.5 of the TBT Agreement provides: “The provisions of this Agreement do not apply to sanitary and phytosanitary measures as defined in Annex A of the Agreement on the Application of Sanitary and Phytosanitary Measures.” back to text
268. Panel Report on EC — Hormones (Canada), para. 8.32; Panel Report on EC — Hormones (US), para. 8.29. back to text
269. Panel Report on EC — Hormones (Canada), para. 8.45; Panel Report on EC — Hormones (US), para. 8.42. back to text
270. Panel Report on EC — Hormones (Canada), para. 8.275. The Panel on EC — Hormones (US) exercised judicial economy with respect to the US claim under Articles I and III. Panel Report on EC — Hormones (US), para. 8.272. back to text
271. Panel Report on Australia — Salmon, para. 8.185. With respect to judicial economy in general, see Chapter on DSU, paras. Section XXXVI.F. back to text
272. Panel Report on EC — Hormones (Canada), para. 8.39; Panel Report on EC — Hormones (US), para. 8.36. back to text
273. (footnote original) Preambular para. 6 of the SPS Agreement. back to text
274. (footnote original) Preambular para. 2 of the SPS Agreement. back to text
275. Panel Report on EC — Hormones (Canada), para. 8.41; Panel Report on EC — Hormones (US), para. 8.38. back to text
276. Panel Report on Australia — Salmon, para. 8.39. back to text
277. Panel Report on Australia — Salmon, para. 8.34. back to text
278. Panel Report on Australia — Salmon (Article 21.5 — Canada), paras. 7.68–7.70. back to text
279. Appellate Body Report on Australia — Salmon, para. 120. back to text
280. Panel Report on Australia — Salmon, paras. 8.72 and 8.116. back to text
281. Panel Report on Australia — Salmon, para. 8.74. back to text
282. Appellate Body Report on Australia — Salmon, paras. 123–124. back to text
283. Panel Report on Japan — Apples, para. 8.273, referring to Appellate Body Report in EC — Hormones, para. 184. back to text
284. (footnote original) Panel Report, para. 8.285. back to text
285. (footnote original) Panel Report, para. 8.283. (original italics) back to text
286. (footnote original) Shorter Oxford English Dictionary, 5th ed., W.R. Trumble, A. Stevenson (eds.) (Oxford University Press, 2002), Vol. I, p. 1725. back to text
287. Appellate Body Report on Japan — Apples, paras. 207–208. back to text
288. (footnote original) Indeed, we are of the view that, as a general matter, “risk” cannot usually be understood only in terms of the disease or adverse effects that may result. Rather, an evaluation of risk must connect the possibility of adverse effects with an antecedent or cause. For example, the abstract reference to the “risk of cancer” has no significance, in and of itself, under the SPS Agreement; but when one refers to the “risk of cancer from smoking cigarettes”, the particular risk is given content. back to text
289. (footnote original) Appellate Body Report, para. 199. (original italics) In other words, the risk assessment proffered by the importing Member in EC — Hormones considered the relationship between the broad grouping of hormones that were the subject of the measure and cancer. back to text
290. (footnote original) Appellate Body Report, para. 200. back to text
291. (footnote original) Panel Report, para. 8.270. back to text
292. (footnote original) Appellate Body Report, para. 7.14. back to text
293. (footnote original) Panel Report, para. 7.14. back to text
294. Appellate Body Report on Japan — Apples, paras. 202–203. back to text
295. Appellate Body Report on Australia — Salmon, fn. 69. back to text
296. Panel Report on EC — Hormones (Canada), para. 8.101; Panel Report on EC — Hormones (US), para. 8.98. back to text
297. Appellate Body Report on EC — Hormones, para. 184. back to text
298. Japan’s appellant’s submission, paras. 127–128. back to text
299. Appellate Body Report on Japan — Apples, para. 204. back to text
300. Appellate Body Report on Japan — Agricultural Products II, paras. 105–107. back to text
301. WT/MIN(01)/17, para. 3.2. back to text
302. Panel Report on Australia — Salmon, para. 7.15. back to text
303. Appellate Body Report on Australia — Salmon, para. 205. back to text
304. (footnote original) This approach is in line with the discussion of the concept of “significant effect on trade of other Members” in the notification procedures adopted and revised by the SPS Committee G/SPS/7/Rev.2, para. 7). back to text
305. This approach is in line with the discussion of the concept of “significant effect on trade of other Members” in the notification procedures adopted and revised by the SPS Committee G/SPS/7/Rev.2, para. 7). back to text
306. Appellate Body in Korea — Dairy, para. 139. back to text
307. (footnote original) Appellate Body Report in Japan — Agricultural Products II, para.126. back to text
308. Panel Report on Japan — Apples, paras. 8.314–8–318. back to text
309. Panel Report on Australia — Salmon (Article 21.5 — Canada), paras. 7.154–7.157. back to text