WORLD TRADE  
ORGANIZATION  WT/DS321/AB/R 
16 October 2008 
 (08-4927) 
 Original:   English 
  
 
     
 
CANADA – CONTINUED SUSPENSION  OF OBLIGATIONS IN THE  
EC – HORMONES DISPUTE 
 
AB-2008-6 
  
 
 
Report of the Appellate Body 
  WT/DS321/AB/R 
 Page i 
 
 
I. Introduction................................................................................................................ .................1 
II. Arguments of the Participants  and the Third Participants ........................................................16 
A. Claims of the European Communities – Appellant ......................................................16 
1. Procedural Issue – Public Observation of the Oral Hearing ...........................16  
2. Articles 23.2(a) and 21.5 of the DSU .............................................................18  
3. Article 22.8 of the DSU ..................................................................................21  
4. The Panel's Terms of Reference .....................................................................24  
5. The Panel's Suggestion for Implementation ...................................................25  
6. The Panel's Selection of Experts.....................................................................26  
7. Article 5.1 of the  SPS Agreement ..................................................................29  
8. Article 5.7 of the  SPS Agreement ..................................................................34  
B. Arguments of the United States – Appellee ..................................................................41 
1. Procedural Issue – Public Observation of the Oral Hearing ...........................41  
2. Articles 23.2(a) and 21.5 of the DSU .............................................................44  
3. Article 22.8 of the DSU ..................................................................................45  
4. The Panel's Terms of Reference .....................................................................47  
5. The Panel's Suggestion for Implementation ...................................................48  
6. The Panel's Selection of Experts.....................................................................49  
7. Article 5.1 of the  SPS Agreement ..................................................................50  
8. Article 5.7 of the  SPS Agreement ..................................................................55  
C. Arguments of Canada – Appellee ................................................................................58 
1. Procedural Issue – Public Observation of the Oral Hearing ...........................58  
2. Articles 23.2(a) and 21.5 of the DSU .............................................................60  
3. Article 22.8 of the DSU ..................................................................................62  
4. The Panel's Terms of Reference .....................................................................63  
5. The Panel's Suggestion for Implementation ...................................................64  
6. The Panel's Selection of Experts.....................................................................65  
7. Article 5.1 of the  SPS Agreement ..................................................................66  
8. Article 5.7 of the  SPS Agreement ..................................................................71  
D. Claims of the United States – Other Appellant ............................................................75 
1. Alleged Discrepancies in the Panel's Description of the Measure at 
Issue ................................................................................................................75  
2. The Panel's Findings under Article 23.1 of the DSU......................................76  
3. The Panel's Findings under Article 23.2(a) of the DSU .................................78  
4. The Scope of the Panel's Mandate  and the Panel's Suggestion.......................79  
5. Conclusion ......................................................................................................80  
E. Claims of Canada – Other Appellant ...........................................................................80 
1. The Panel's Examination of Articl es 23.1 and 23.2(a) "In Isolation" 
from Article 22.8 of the DSU .........................................................................81  
2. The Panel's Findings under Article 23.1 of the DSU......................................83  
3. The Panel's Findings under Article 23.2(a) of the DSU .................................84  
4. The Scope of the Panel's Mandate  and the Panel's Suggestion.......................84  
5. Conclusion ......................................................................................................85  
F. Arguments of the European Communities – Appellee .................................................86 
1. The "Harmonious" Interpretation of Articles 21, 22, and 23 of the DSU 
in the Post-Suspension Stage of a Dispute......................................................86  WT/DS321/AB/R 
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2.
 The Panel's Findings under Article 23.1 of the DSU......................................89  
3. The Panel's Findings under Article 23.2(a) of the DSU .................................90  
4. The Scope of the Panel's Mandate  and the Panel's Suggestion.......................91  
G. Arguments of the Third Participants ............................................................................92 
1. Australia..........................................................................................................92  
2. Brazil...............................................................................................................97  
3. China.............................................................................................................100  
4. India ..............................................................................................................100  
5. Mexico ..........................................................................................................101  
6. New Zealand.................................................................................................101  
7. Norway .........................................................................................................105  
8. Separate Customs Territory of Ta iwan, Penghu, Kinmen and Matsu ..........107  
III. Issues Raised in This Appeal .............................................................................................. ....107 
IV. The Application of the DSU in the Post-Suspension Stage of a Dispute................................110 
A. Introduction ...............................................................................................................110 
B. The Panel's Findings .................................................................................................112 
1. Scope of the European Communities' Claims...............................................112  
2. The European Communities' Claim th at the United States and Canada 
Breached Article 23.2(a) of the DSU Read Together with Articles 23.1 and 21.5.........................................................................................................114
 
3. The European Communities' Claim th at the United States and Canada 
Breached Article 23.1 of the DSU Read Together with Articles 22.8 
and 3.7...........................................................................................................116  
4. The Panel's Jurisdiction ................................................................................119  
5. Burden of Proof ............................................................................................120  
6. The Panel's Suggestion .................................................................................122  
C. Claims and Arguments on Appeal ..............................................................................122 
1. Appeal by the European Communities .........................................................122  
2. Other Appeals by the United States and Canada ..........................................124  
3. Arguments of the Third Participants.............................................................127  
D. Cessation of the Suspension of Con cessions – Article 22.8 of the DSU ....................128 
1. Preliminary Comments .................................................................................128  
2. When Must a WTO Member Cease to Suspend Concessions Pursuant 
to Article 22.8 of the DSU? ..........................................................................129  
3. The Panel's Analysis Concerning Article 22.8 of the DSU ..........................134  
4. Did the Panel Exceed Its Mandate by Addressing the Conformity of Directive 2003/74/EC with the  SPS Agreement ?.........................................138
 
E. Procedural Avenues for Resolving Disagreements as to Whether the 
Inconsistent Measure Has Been Re moved under Article 22.8 of the DSU ................143  
1. What Is the Appropriate Procedural  Avenue to Resolve a Disagreement 
as to Whether the Inconsistent Measure Has Been Removed?.....................143  
2. Is the European Communities Precluded from Initiating an Article 21.5 Panel Proceeding Regarding Whether Directive 2003/74/EC Has 
Brought It into Compliance?.........................................................................148
 
F. Analysis of the Panel's Findings of "Procedural Violations" ....................................155  WT/DS321/AB/R 
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1. The Prohibition on Certain Unilateral Actions – Article 23 of the DSU......155  
2. The Panel's Alleged Examination of Articles 23.2(a) and 23.1 in 
Isolation from the Requirements in Article 22.8 of the DSU .......................158  
3. Whether the Panel Erred in Finding that the United States and Canada Are "Seeking the Redress of a Viola tion" with Respect to Directive 
2003/74/EC...................................................................................................161
 
4. Whether the Panel Erred in Finding that the United States and Canada 
Made a Determination of Violati on Without Recourse to the DSU, 
Within the Meaning of Article 23.2(a) .........................................................165  
5. Conclusion ....................................................................................................170  
G. The Panel's Finding that It Had No Jurisdiction to Make Findings under the 
SPS Agreement ...........................................................................................................171 
H. The Panel's Suggestion ..............................................................................................171 
V. Due Process in the Panel's Consultati ons with the Scientific Experts ....................................172 
A. The Panel's Findings .................................................................................................172 
B. Claims and Arguments on Appeal ..............................................................................177 
C. Did the Panel Infringe the European Communities' Due Process Rights and 
Fail to Make an Objective Assessment of the Matter in the Consultations with 
the Scientific Experts .................................................................................................180 
VI. The Consistency with Article 5.1 of the  SPS Agreement   of the European 
Communities' Import Ban on Meat from Cattle Treated with Oestradiol-17 β for 
Growth-Promotion Purposes...................................................................................................202  
A. Introduction ...............................................................................................................202 
B. The European Communities' Risk Assess ment for Meat from Cattle Treated 
with Oestradiol-17 β...................................................................................................203 
C. The Panel's Findings .................................................................................................207 
D. Claims and Arguments on Appeal ..............................................................................215 
E. The Panel's Assessment of Directive 2003/74/EC under Article 5.1 of the  SPS 
Agreement ..................................................................................................................219  
1. General Disciplines Applicable to the Adoption of an SPS Measure...........219  
2. The Panel's Interpretation and Appli cation of Articles 5.1 and 5.2 of 
the  SPS Agreement .......................................................................................225  
3. The Panel's Specificity Requirement ............................................................234  
4. Quantification of Risk...................................................................................238  
5. Burden of Proof ............................................................................................241  
6. The Panel's Articulation and Application of the Standard of Review 
under Article 5.1 of the  SPS Agreement ......................................................245  
F. Conclusion .................................................................................................................256 
VII. The Consistency with Article 5.7 of the  SPS Agreement   of the European 
Communities' Provisional Import Ban on Meat from Cattle Treated with Testosterone, Progesterone, Trenbolone Acetate, Zeranol, and MGA for Growth-Promotion Purposes .....257 WT/DS321/AB/R 
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A. Introduction ...............................................................................................................257 
B. The European Communities' Evaluation of the Five Hormones Subject to the 
Provisional Ban .........................................................................................................258 
C. The Panel's Findings .................................................................................................260 
D. Claims and Arguments on Appeal ..............................................................................276 
E. The Panel's Finding that the Relevant Scientific Evidence in Relation to the 
Five Hormones Was Not "Insufficient" With in the Meaning of Article 5.7 of the 
SPS Agreement ...........................................................................................................282
 
1. Insufficiency and the Acceptable Level of Protection..................................286  
2. Relevance of International Standa rds under Article 5.7 of the  SPS 
Agreement .....................................................................................................289  
3. The Panel's "Critical Mass" Standard  for Determining "Insufficiency" 
under Article 5.7 of the  SPS Agreement ......................................................293  
4. The Panel's Allocation of the Burden of Proof under Article 5.7 of the 
SPS Agreement ..............................................................................................297  
5. The Panel's Application of Article 5.7 of the  SPS Agreement .....................300  
F. Conclusions ................................................................................................................305 
VIII. Findings and Conclusions................................................................................................. ......306 
 ANNEX I Notification of an App eal by the European Communities 
 
ANNEX II Notification of an Other Appeal by the United States  
 ANNEX III  Notification of an Other Appeal by Canada  ANNEX IV  Procedural Ruling of 10 July 2008 to  allow public observation of the oral hearing 
  WT/DS321/AB/R 
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TABLE OF CASES CITED IN THIS REPORT 
 
Short Title Full Case Title and Citation 
Argentina – Footwear (EC)  Appellate Body Report, Argentina – Safeguard Me asures on Imports of 
Footwear , WT/DS121/AB/R, adopted 12  January 2000, DSR 2000:I, 515 
Argentina – Textiles and 
Apparel  Appellate Body Report, Argentina – Measures Affecting Imports of 
Footwear, Textiles, Apparel and Other Items , WT/DS56/AB/R and 
Corr.1, adopted 22 Apri l 1998, DSR 1998:III, 1003 
Australia – Salmon  Appellate Body Report, Australia – Measures Af fecting Importation of 
Salmon , WT/DS18/AB/R, adopted 6 November 1998, DSR 1998:VIII, 
3327 
Brazil – Desiccated Coconut
  Appellate Body Report, Brazil – Measures Affecting Desiccated Coconut , 
WT/DS22/AB/R, adopted 20 March 1997, DSR 1997:I, 167 
Brazil – Retreaded Tyres Appellate Body Report, Brazil – Measures Affecting Imports of Retreaded 
Tyres , WT/DS332/AB/R, adopted 17 December 2007 
Canada – Aircraft  Appellate Body Report, Canada – Measures Affecting the Export of 
Civilian Aircraft , WT/DS70/AB/R, adopted 20 August 1999, 
DSR 1999:III, 1377 
Canada – Aircraft  (Article 21.5 – Brazil)
  Appellate Body Report, Canada – Measures Affecting the Export of 
Civilian Aircraft – Recourse by Brazil to Article 21.5 of the DSU , 
WT/DS70/AB/RW, adopted 4 August 2000, DSR 2000:IX, 4299 
Canada – Continued 
Suspension Panel Report, Canada – Continued Suspension of Obligations in the 
EC – Hormones Dispute , WT/DS321/R, circulated to WTO Members 31 
March 2008  
Canada – Wheat Exports and Grain Imports Appellate Body Report, Canada – Measures Relating to Exports of Wheat 
and Treatment of Imported Grain , WT/DS276/AB/R, adopted 
27 September 2004, DSR 2004:VI, 2739 
Chile – Price Band System (Article 21.5 – Argentina) Appellate Body Report, Chile – Price Band System and Safeguard 
Measures Relating to Certain Agricultu ral Products – Recourse to Article 
21.5 of the DSU by Argentina , WT/DS207/AB/RW, adopted 22 May 2007 
EC – Approval and 
Marketing of Biotech Products Panel Report, European Communities – Measures Affecting the Approval 
and Marketing of Biotech Products , WT/DS291/R, WT/DS292/R, 
WT/DS293/R, Corr.1, and Add.1 to Ad d.9, adopted 21 November 2006, 
DSR 2006:III, 847 
EC – Asbestos  Appellate Body Report, European Communities – Measures Affecting 
Asbestos and Asbestos-Containing Products , WT/DS135/AB/R, adopted 
5 April 2001, DSR 2001:VII, 3243 
EC – Commercial Vessels Panel Report, European Communities – Measures Affecting Trade in 
Commercial Vessels , WT/DS301/R, adopted 20 June 2005, DSR 
2005:XV, 7713 
EC – Hormones  Appellate Body Report, EC Measures Concer ning Meat and Meat 
Products (Hormones) , WT/DS26/AB/R, WT/DS48/AB/R, adopted 
13 February 1998, DSR 1998:I, 135 WT/DS321/AB/R 
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Short Title Full Case Title and Citation 
EC – Hormones  Award of the Arbitrator, EC Measures Concer ning Meat and Meat 
Products (Hormones) – Arbitration under Article 21.3(c) of the DSU , 
WT/DS26/15, WT/DS48/13, 29 May 1998, DSR 1998:V, 1833 
EC – Hormones (Canada)  Panel Report, EC Measures Concerning Meat and Meat Products 
(Hormones), Complaint by Canada , WT/DS48/R/CAN, adopted 
13 February 1998, as modified by Appellate Body Report, WT/DS26/AB/R, WT/DS48/ AB/R, DSR 1998:II, 235 
EC – Hormones (Canada) 
(Article 22.6 – EC)  Decision by the Arbitrators, European Communities – Measures 
Concerning Meat and Meat Products (H ormones), Original Complaint by 
Canada – Recourse to Arbitration by  the European Communities under 
Article 22.6 of the DSU , WT/DS48/ARB, 12 July 1999, DSR 1999:III, 
1135 
EC – Hormones (US)  Panel Report, EC Measures Concerning Meat and Meat Products 
(Hormones), Complaint by the United States , WT/DS26/R/USA, adopted 
13 February 1998, as modified by Appellate Body Report, WT/DS26/AB/R, WT/DS48/ AB/R, DSR 1998:III, 699 
EC – Hormones (US)  
(Article 22.6 – EC)  Decision by the Arbitrators, European Communities – Measures 
Concerning Meat and Meat Products (H ormones), Original Complaint by 
the United States  – Recourse to Arbitration by the European 
Communities under Article 22.6 of the DSU , WT/DS26/ARB, 12 July 
1999, DSR 1999:III, 1105 
EC – Sardines  Panel Report, European Communities – Trade Description of Sardines , 
WT/DS231/R and Corr.1, adopted 23 October 2002, as modified by 
Appellate Body Report, WT /DS231/AB/R, DSR 2002:VIII, 3451 
India – Patents (US)  Appellate Body Report, India – Patent Protection for Pharmaceutical 
and Agricultural Chemical Products , WT/DS50/AB/R, adopted 
16 January 1998, DSR 1998:I, 9 
Japan – Agricultural Products II  Appellate Body Report, Japan – Measures Affecting Agricultural 
Products , WT/DS76/AB/R, adopted 19 March 1999, DSR 1999:I, 277 
Japan – Apples  Appellate Body Report, Japan Measures Affecting the Importation of 
Apples , WT/DS245/AB/R, adopted 10 December 2003, DSR 2003:IX, 
4391 
Japan – Apples  Panel Report, Japan – Measures Affecting the Importation of Apples , 
WT/DS245/R, adopted 10 December 20 03, upheld by Ap pellate Body 
Report, WT/DS245/AB/R, DSR 2003:IX, 4481  
Mexico – Corn Syrup  
(Article 21.5 – US)  Appellate Body Report, Mexico – Anti-Dumping Investigation of High 
Fructose Corn Syrup (HFCS) from the United States – Recourse to Article 
21.5 of the DSU  by the United States , WT/DS132/AB/RW, adopted 
21 November 2001, DSR 2001:XIII, 6675 
Thailand – H-Beams  Appellate Body Report, Thailand – Anti-Dumping Duties on Angles, 
Shapes and Sections of Iron or N on-Alloy Steel and H-Beams from 
Poland , WT/DS122/AB/R, adopted 5 April 2001, DSR 2001:VII, 2701 
US – 1916 Act  Appellate Body Report, United States – Anti-Dumping Act of 1916 , 
WT/DS136/AB/R, WT/DS162/AB/R , adopted 26 September 2000, 
DSR 2000:X, 4793  WT/DS321/AB/R 
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Short Title Full Case Title and Citation 
US – Carbon Steel  Appellate Body Report, United States – Counterva iling Duties on Certain 
Corrosion-Resistant Carbon Stee l Flat Products from Germany , 
WT/DS213/AB/R and Corr.1, adopted  19 December 2002, DSR 2002:IX, 
3779 
US – Certain EC Products  Panel Report, United States – Import Meas ures on Certain Products from 
the European Communities , WT/DS165/R and Add.1, adopted 10 January 
2001, as modified by Appellat e Body Report, WT/DS165/AB/R, 
DSR 2001:II, 413 
US – Continued Suspension Panel Report, United States – Continued Suspension of Obligations in 
the EC – Hormones Dispute , WT/DS320/R, circulated to WTO 
Members 31 March 2008  
US – FSC  Panel Report, United States – Tax Treatment for "Foreign Sales 
Corporations" , WT/DS108/R, adopted 20 March 2000, as modified by 
Appellate Body Report, WT /DS108/AB/R, DSR 2000:IV, 1675 
US – FSC  
(Article 21.5 – EC)  Appellate Body Report, United States – Tax Treatment for "Foreign Sales 
Corporations" – Recourse to Article 21.5 of the DSU by the European 
Communities , WT/DS108/AB/RW, adopted 29 January 2002, 
DSR 2002:I, 55 
US – Gambling Appellate Body Report, United States – Measures Affecting the Cross-
Border Supply of Gambling and Betting Services , WT/DS285/AB/R, 
adopted 20 April 2005, DSR 2005:XII, 5663, and Corr.1 
US – Offset Act  (Byrd Amendment
 ) Appellate Body Report, United States – Continued Dumping and Subsidy 
Offset Act of 2000 , WT/DS217/AB/R, WT/DS234/AB/R, adopted 
27 January 2003, DSR 2003:I, 375 
US – Offset Act  (Byrd Amendment
 ) Panel Report, United States – Continued Dumping and Subsidy Offset Act 
of 2000 , WT/DS217/R, WT/DS234/R, adopted 27 January 2003, as 
modified by Appe llate Body Report, WT/DS217/AB/R, 
WT/DS234/AB/R, DSR 2003:II, 489 
US – Section 211 Appropriations Act Appellate Body Report, United States – Section 211 Omnibus 
Appropriations Act of 1998 , WT/DS176/AB/R, adopted 1 February 
2002, DSR 2002:II, 589 
US – Section 301 Trade Act  Panel Report, United States – Sections 301-310 of the Trade Act of 1974 , 
WT/DS152/R, adopted 27 January 2000, DSR 2000:II, 815 
US – Shrimp Appellate Body Report, United States – Import Prohibition of Certain 
Shrimp and Shrimp Products , WT/DS58/AB/R, adopted 6 November 
1998, DSR 1998:VII, 2755 
US – Shrimp  (Article 21.5 – Malaysia) Appellate Body Report, United States – Import Prohibition of Certain 
Shrimp  and Shrimp Products – Recourse  to Article 21.5 of the DSU by 
Malaysia , WT/DS58/AB/RW, adopted 21 November 2001, 
DSR 2001:XIII, 6481 
US – Softwood Lumber IV (Article 21.5 – Canada) Appellate Body Report, United States – Final Countervailing Duty 
Determination with Respect to Certain Softwood Lumber from Canada – 
Recourse by Canada to Article 21.5 of the DSU , WT/DS257/AB/RW, 
adopted 20 December 2005, DSR 2005:XXIII, 11357 WT/DS321/AB/R 
Page viii  
 
Short Title Full Case Title and Citation 
US – Softwood Lumber VI 
(Article 21.5 – Canada) Appellate Body Report, United States – Investigation of the International 
Trade Commission in Softwood Lumb er from Canada – Recourse to 
Article 21.5 of the DSU by Canada , WT/DS277/AB/RW, adopted 9 May 
2006, and Corr.1 
US – Underwear Panel Report, United States – Restrictions  on Imports of Cotton and Man-
made Fibre Underwear , WT/DS24/R, adopted 25 February 1997, as 
modified by Appellat e Body Report, WT/DS24/AB/R, DSR 1997:I, 31 
US – Upland Cotton 
(Article 21.5 – Brazil) Appellate Body Report, United States – Subsidies on Upland Cotton – 
Recourse to Article 21.5 of the DSU by Brazil , WT/DS267/AB/RW, 
adopted 20 June 2008 
US – Wool Shirts and Blouses  Appellate Body Report, United States – Measure Affecting Imports of 
Woven Wool Shirts and Blouses from India , WT/DS33/AB/R, adopted 
23 May 1997, and Corr.1, DSR 1997:I, 323  
  WT/DS321/AB/R 
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LIST OF ABBREVIATIONS USED IN THIS REPORT 
 
Abbreviation Description 
1999 Opinion "Opinion of the SCVPH – Assessment of Potential Risks to Human 
Health from Hormone Residues in Bovine Meat and Meat Products" 
(30 April 1999) (Exhibits US-4 and CDA-2 submitted by the United 
States and Canada, respectively, to the Panel) 
2000 Opinion "Review of Specific Documents relating to the SCVPH Opinion of 
30 April 99 on the Potential Risk s to Human Health from Hormone 
Residues in Bovine Meat and Meat Products" (adopted on 3 May 2000) (Exhibits US-17 and CDA-4 submitte d by the United States and Canada, 
respectively, to the Panel)   
2002 Opinion "Opinion of the SCVPH on Review of Previous SCVPH Opinions of 
30 April 1999 and 3 May 2000 on the Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products" (adopted 
on 10 April 2002) (Exhibits US-1 and CDA-17 submitted by the United 
States and Canada, respectively, to the Panel)   
ADI Acceptable daily intake 
Codex Codex Alimentarius Commission 
CVMP Committee on Veterinary Medicinal Products of the European Union (a 
subcommittee of the European  Medicines Agency (EMEA)) 
DSB Dispute Settlement Body 
DSU Understanding on Rules and Procedures Governing the Settlement of 
Disputes  
FAO Food and Agriculture Organization of the United Nations 
FDA Food and Drug Administration of the United States 
GATT 1994 General Agreement on Tariffs and Trade 1994   
IARC  International Agency for Research on Cancer  
JECFA Joint FAO/WHO Expert Committee on Food Additives  
MGA Melengestrol acetate 
MRLs Maximum residue limits 
Panel Report, Canada – 
Continued Suspension  Panel Report, Canada – Continued Suspension of Obligations in the 
EC – Hormones Dispute , WT/DS321/R 
Panel Report, US – 
Continued Suspension  Panel Report, United States – Continued Suspension of Obligations in 
the EC – Hormones Dispute , WT/DS320/R 
Rules of Conduct Rules of Conduct for the Understanding on Rules and Procedures 
Governing the Settlement of Disputes , WT/DSB/RC/1, adopted 
3 December 1996  
SCVPH Scientific Committee on Veterinary Measures relating to Public Health of 
the European Commission 
SPS Agreement Agreement on the Applicat ion of Sanitary and Phytosanitary Measures  
TBT Agreement Agreement on Technical Barriers to Trade  WT/DS321/AB/R 
Page x  
 
Abbreviation Description 
Vienna Convention Vienna Convention on the Law of Treaties , done at Vienna, 23 May 
1969, 1155 UNTS 331;  8 International Legal Materials 679  
WHO World Health Organization of the United Nations 
WTO Agreement Marra kesh Agreement Establishing the World Trade Organization   
  WT/DS321/AB/R 
 Page 1 
 
 
WORLD TRADE ORGANIZATION  
APPELLATE BODY 
 
  
Canada – Continued Suspension of Obligations in the EC – Hormones Dispute 
 European Communities, Appellant/Appellee  
United States, Other Appellant/Appellee  
Canada, Other Appellant/Appellee  
 Australia, Third Participant  
Brazil, Third Participant  
China, Third Participant  
India, Third Participant  
Mexico, Third Participant  
New Zealand, Third Participant  
Norway, Third Participant  
Separate Customs Territo ry of Taiwan, Penghu, 
 Kinmen and Matsu, Third Participant   
   
 AB-2008-6   
 Present: 
  Unterhalter, Presiding Member  Abi-Saab, Member  Bautista, Member 
 
 
 
I. Introduction 
1. The European Communities, the Un ited States, and Canada each appeals certain issues of law 
and legal interpretations deve loped in the Panel Report, United States – Continued Suspension of 
Obligations in the EC – Hormones Dispute
 1 (the "Panel Report, US – Continued Suspension "), and 
the Panel Report, Canada – Continued Suspension of Obligations in the EC – Hormones Dispute 2 
(the "Panel Report, Canada – Continued Suspension ").3  The Panels were established to consider 
complaints by the European Communities concer ning the suspension of concessions or other 
obligations by the United States and by Canada against the European Co mmunities because of the 
latter's alleged failure to comply with the reco mmendations and rulings of the Dispute Settlement 
Body (the "DSB") stemming from the  EC – Hormones  dispute.4  The European Communities asserts 
that the United States and Canada must cease th e suspension of concessions because the European 
                                                      
1WT/DS320/R, 21 March 2008. 
2WT/DS321/R, 21 March 2008. 
3In this Report, we refer to the United States first and then to Canada, in keeping with the chronology 
of the WT/DS numbers assigned to these disputes. 
4The recommendations and rulings of the DSB resulted from the adoption on 13 February 1998, by the 
DSB, of the Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R;  the Panel Report, WT/DS26/R/USA;  
and the Panel Report, WT/DS48/R/CAN.   WT/DS321/AB/R 
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Communities adopted Directive 2003/74/EC
5 and notified it to the DSB as a measure taken to comply 
with the DSB's recommendations and rulings in  EC – Hormones .6   
2. Before the panels in  EC – Hormones 7, the United States and Canada claimed that the ban 
imposed by the European Communities on meat fro m cattle treated with si x hormones—oestradiol-17 β, 
progesterone, testosterone, trenbolone acetate, zeranol, and melengestrol acetate ("MGA")—was 
inconsistent with the  Agreement on the Application of San itary and Phytosanitary Measures  (the " SPS 
Agreement "), in particular, Articles 2, 3, and 5 thereof, the  Agreement on Technical Barriers to Trade 
(the " TBT Agreement "), and the  General Agreement on Tariffs and Trade 1994  (the "GATT 1994"). 
3. The panel in  EC – Hormones  held that: 
− by maintaining sanitary measures that are not based on a risk assessment, the European 
Communities had acted inconsistently with Article 5.1 of the  SPS Agreement ;  
− by adopting arbitrary or unjustifiable distinc tions in the levels of sanitary protection it 
considered appropriate in different situations  which result in discrimination or a disguised 
restriction on international trade, the Europ ean Communities had acted inconsistently with 
Article 5.5 of the  SPS Agreement ;  and   
− by maintaining sanitary measures that are not  based on existing international standards 
without justification under Article 3.3 of the  SPS Agreement , the European Communities had 
acted inconsistently with Ar ticle 3.1 of that Agreement.8 
4. The European Communities appealed the panel's findings under Articles 3.1, 3.3, 5.1, and 5.5 
of the  SPS Agreement .  In addition, the European Communities claimed that the panels had erred in 
the selection and use of scientific experts, in a llocating the burden of proof, and in applying the 
standard of review.  The United States and Canada ap pealed the panel's decision not to make findings 
relating to Articles 2.2 and 5.6 of the  SPS Agreement .   
                                                      
5Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 amending 
Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having 
a hormonal or thyrostatic action and of beta-agonists, Official Journal of the European Union , L Series, No. 262 
(14 October 2003) 17 (Exhibits EC-1 and US-3 submitted by the European Communities and the United States, respectively, to the Panel). 
6Panel Report, US – Continued Suspension , para. 1.1;  Panel Report, Canada – Continued Suspension , 
para. 1.1. 
7As the same individuals served on both panels, in this Report we will henceforth refer to the panels in 
the singular. 
8Panel Report, EC – Hormones (US) , para. 9.1;  Panel Report, EC – Hormones (Canada) , para. 9.1.  WT/DS321/AB/R 
 Page 3 
 
 
5. The Appellate Body upheld, albeit on the basis of  modified reasoning, the panel's findings that 
the European Communities' import ban on meat and meat products tr eated with the six hormones at 
issue was inconsistent with Article 5.1 of the  SPS Agreement , and, as a consequence, was also 
inconsistent with Article 3.3 of that Agreement.  The Appellate Body found that the scientific studies submitted by the European Communities in that disput e were not "sufficiently specific to the case at 
hand"
9, because they were "general studies which do ind eed show the existence of a general risk of 
cancer;  but they do not focus on and do not address the particular kind of risk here at stake".10  For 
this reason, the Appellate Body concluded that "no risk assessmen t that reasonably support[ed] or 
warrant[ed] the import prohibition embodied in the [European Communities'] Directives was 
furnished to the Panel"11, and accordingly found that the European Communities' import ban, imposed 
under Directive 96/22/EC, was not "based on" a risk assessment within the meaning of Article 5.1.  
Moreover, the Appellate Body disagreed with the panel's interpretation of the relationship between 
Articles 3.1 and 3.3 of the  SPS Agreement .  The panel interpreted Article 3.3 to be an exception to the 
"general obligation" of Article 3.1, and found that the European Communities had not acted consistently with Article 3.1 and had not provided appropriate scientif ic justification for a higher level 
of SPS protection under Article 3.3.  The Appellate Body concluded, however, that the right of 
Members to establish a higher level of sanitary pr otection under Article 3.3 is an autonomous right 
and not an exception to a "general obligation" under Article 3.1.  Accordingly, the Appellate Body reversed the panel's conclusion that the import pr ohibition was inconsistent with Article 3.1.  
Nevertheless, as the Appellate Body found that the European Communities' import prohibition was 
inconsistent with Article 5.1, it also concluded that the import prohibition was inconsistent with 
Article 3.3.  The Appellate Body, however, modified  the panel's interpretation of "risk assessment" by 
holding that there was no requirement "to establish a minimum quantifiable magnitude of risk", and that the factors "not susceptible of quantitative anal ysis by the empirical or experimental laboratory 
methods commonly associated with the physical sciences" were not excluded from the scope of a risk 
assessment.
12  The Appellate Body also reversed the pa nel's findings that the European Communities 
had acted inconsistently wi th Article 5.5 of the  SPS Agreement , which requires that a WTO Member 
avoid arbitrary or unjustifiable di stinctions in the levels of sanitary protection that result in 
discrimination or a disgui sed restriction on international trade.  Furthermore, the Appellate Body agreed 
with the panel that the precautionary principle woul d not override Articles 5.1 and 5.2 and that it had 
been incorporated in, inter alia , Article 5.7 of the  SPS Agreement .  With regard to the selection and use 
of experts by the panel, the Appella te Body concluded that the panel had acted consistently with the
                                                      
9Appellate Body Report, EC – Hormones , para. 200.   
10Ibid. 
11Ibid., para. 208.  
12Ibid., para. 253(j). WT/DS321/AB/R 
Page 4  
 
requirements of the  Understanding on Rules and Procedures Governing the Settlement of Disputes  
(the "DSU") and the  SPS Agreement .  The Appellate Body rejected the European Communities' claim 
that the panel had erred in the standard applied to the review of the evidence and thus found that the 
panel had complied with its oblig ation under Article 11 of the DSU.   Finally, the Appellate Body 
concluded that the panel's exercise of judici al economy was proper in not making findings under 
Articles 2.2 and 5.6 of the  SPS Agreement . 
6. On 13 February 1998, the DSB adopted the panel and Appellate Body Reports in  EC –
Hormones  and recommended that the European Communiti es bring its measures into conformity with 
the  SPS Agreement .  Following the adoption of the panel and Appellate Body reports by the DSB, the 
European Communities requested that the reasonable period of time for implementation be 
determined through arbitration in accordance with  Article 21.3(c) of the DSU.  The Arbitrator 
determined a reasonable period of time of 15 months, expiring on 13 May 1999.
13   
7. On 12 May 1999, the European Communities addr essed a communication to the Chairman of 
the DSB, which stated: 
[T]he Community has undertaken a complementary risk assessment 
in light of the relevant clarifica tions on risk assessment provided by 
the Appellate Body. 
In light of such results of that risk assessment as are now available to 
it, the Community is not in a position to lift its existing import ban 
on 13 May. 
The Community now intends to study in more depth these results in 
order to evaluate on this basis and in the light of any new relevant information what steps may be necessary in light of our WTO rights and obligations.
14 
8. As a result, the United States and Canada re quested the DSB to authorize suspension of 
concessions and other obligations pursuant to Artic le 22.2 of the DSU.  The European Communities 
objected to the levels of suspension of concessi ons proposed by the United States and Canada, and 
requested that such levels be de termined through arbitration pursuant to Article 22.6 of the DSU.15  
The Arbitrators concluded that the levels of nullifi cation and impairment in relation to United States 
and Canadian meat exports were US$116. 8 million and Can$11.3 million, respectively.16  
On 26 July 1999, the United States and Canada obtained authorization from the DSB to suspend
                                                      
13Award of the Arbitrator, EC – Hormones , para. 48. 
14WT/DS26/18, WT/DS48/16. 
15WT/DS26/20;  WT/DS48/18. 
16Decision by the Arbitrators, EC – Hormones  (US) (Article 22.6 – EC) , para. 83;  Decision by the 
Arbitrators, EC – Hormones  (Canada) (Article 22.6 – EC) , para. 72.  WT/DS321/AB/R 
 Page 5 
 
 
concessions and other obligations in rela tion to the European Communities.   
9. On 29 July 1999, the United States applied 100 per cent import duties on a range of imports 
from certain member States of  the European Communities.17  On 1 August 1999, Canada applied 
100 per cent  ad valorem  duties on a similar range of imports from the European Communities.18 
10. After the adoption of the panel and Appellate Body Reports in the  EC – Hormones  dispute, 
the European Commission initiated 17 scientific studies to assess any risks to human health posed by the 
six hormones at issue.19  On 30 April 1999, the Scientific Comm ittee on Veterinary M easures relating to 
Public Health (the "SCVPH") of the European Communities issued the Assessment of Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products
20 (the "1999 Opinion").  
Subsequent to the adoption of the 1999 Opinion, additional scientific inform ation was made available 
to the European Commission in th e form of scientific studies conducted by:  (i) the United Kingdom's 
Veterinary Products Committee sub-group on the 1999 Opinion (October 1999);  (ii) the Committee 
for Veterinary Medicinal Products ("CVMP") of  the European Union (a subcommittee of the 
European Medicines Agency (EMEA)) (December 1999);  and (iii) the Joint FAO/WHO Expert Committee on Food Additives ("JECFA") (February 2 000).  At the request of the European 
Commission, the SCVPH exam ined this scientific information a nd, on 3 May 2000, issued a review of 
its 1999 Opinion in which it declined to alter the conclusions contained therein
21 (the "2000 Opinion").  
On 10 April 2002, a second review of the 1999 Opinion was issued by the SCVPH22 (the "2002 
Opinion") on the basis of more recent scientific data collected since the previous review.  The
                                                      
17Office of the United States Trade Representa tive, Implementation of WTO Recommendations 
Concerning EC – Measures Concerning Meat and Meat Products (Hormones) , United States Federal Register , 
Vol. 64, No. 143 (27 July 1999) 40638. 
18European Union Surtax Order, Canada Gazette Part II , Vol. 133, No. 17 (18 August 1999).  
19These scientific studies are contained in Exhibits EC-7 (US) through EC-42 (US) and Exhibits 
EC-4 (CDA) through EC-39 (CDA ) submitted by the European Communities to the Panel. 
20"Opinion of the SCVPH – Assessment of Potential Risks to Human Health from Hormone Residues 
in Bovine Meat and Meat Products" (30 April 1999) (Exhibits US-4 and CDA-2 submitted by the United States and Canada, respectively, to the Panel).  The main conclusions of the 1999 Opinion are set out in Panel Report, 
US – Continued Suspension , para. 7.391, and Panel Report, Canada – Continued Suspension , para. 7.388. 
21"Review of Specific Documents relating to the SCVPH Opinion of 30 April 99 on the Potential Risks 
to Human Health from Hormone Residues in Bovine Meat and Meat Products" (adopted on 3 May 2000) 
(Exhibits US-17 and CDA-4 submitted by the United States and Canada, respectively, to the Panel).  The main 
conclusions of the 2000 Opinion are set out in Panel Report, US – Continued Suspension , para. 7.392, and Panel 
Report, Canada – Continued Suspension , para. 7.389. 
22"Opinion of the SCVPH on Review of Previous SCVPH Opinions of 30 April 1999 and 3 May 2000 
on the Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products" (adopted 
on 10 April 2002) (Exhibits US-1 and CDA-17 submitted by the United States and Canada, respectively, to the 
Panel).  The 2002 Opinion confirmed the validity of the 1999 and 2000 Opinions and concluded that no amendments to those Opinions were justified.  The main conclusions of the 2002 Opinion are set out in Panel 
Report, US – Continued Suspension , para. 7.393, and Panel Report, Canada – Continued Suspension , 
para. 7.390. WT/DS321/AB/R 
Page 6  
 
scientific data reviewed by the SCVPH included the final results of all 17 studies that had been 
commissioned by the European Commission.   
11. In the light of the conclusions of the 1999, 2000, and 2002 Opinions, the European 
Communities adopted Directive 2003/74/EC on 22 September 2003
23, which amends 
Directive 96/22/EC in relation to the prohibitio n of the use of hormones in stockfarming.  
Directive 2003/74/EC maintains the permanent prohib ition of the placing on the market of meat and 
meat products from animals treated with oestradiol-17 β for growth-promotion purposes originally 
contained in Directive 96/22/EC.24  In relation to the five other hormones—testosterone, progesterone, 
trenbolone acetate, zeranol, and MGA—Directive 2003/74/EC continues to apply the prohibition 
contained in Directive 96/22/EC, but on a provisional basis.25  Directive 2003/74/EC specifies that, 
even though the scientific information available show ed the existence of risk s associated with these 
substances, "the current state of knowledge does not make it possible to give a quantitative estimate of 
the risk to consumers".26  Accordingly, the prohibition of these five hormones should apply "while the 
Community seeks more complete scientific informat ion from any source, which could shed light and 
clarify the gaps in the present state of knowledge of these substances".27 
12. On 27 October 2003, the European Communities notified the DSB of the adoption, 
publication, and entry into force of Directive 2003/74/EC, as well as the 1999, 2000, and 2002 Opinions, which it considered to be risk assessmen ts that sufficiently justified the permanent and 
provisional import prohibitions under the  SPS Agreement .
28  The European Communities therefore 
claimed that it had fully implemented the DSB's recommendations and rulings in the original  EC – 
Hormones  disputes, and consequently considered that  the suspensions of concessions by the United 
States and Canada were no longer justified.  The United States and Canada refused to lift the 
measures taken pursuant to the DSB's authorization to suspend concessions or other obligations.  The 
European Communities requested consultatio ns with the United States and Canada 
                                                      
23Supra , footnote 5.  
24Directive 2003/74/EC, supra , footnote 5, Recital 10 and Article 1 (amending Articles 2 and 3 of 
Directive 96/22/EC).   
25Ibid. 
26Directive 2003/74/EC, supra , footnote 5, Recital 7.   
27Ibid., Recital 10.  
28WT/DS26/22, WT/DS48/20.   WT/DS321/AB/R 
 Page 7 
 
 
on 8 November 2004.29  The Panel was established, at the request of the European Communities, 
on 17 February 2005.30 
13. Before the Panel, the European Communities put forward two "series of main claims", and a 
conditional "alternative" claim.  In its first "serie s of main claims", the European Communities argued 
that, by maintaining their suspension of concessi ons and other obligations, the United States and 
Canada were seeking redress of a perceived violation of the Marrakesh Agreement Establishing the 
World Trade Organization  (the " WTO Agreement ") without having recourse to the rules and 
procedures of the DSU, in violation of Article 23.2(a) of the DSU read in conjunction with Articles 21.5 and 23.1.
31  The European Communities argued that the United States and Canada 
should have initiated a compliance proceeding under Ar ticle 21.5 of the DSU following notification of 
the implementing measure to the DSB if they consider ed that this measure was not consistent with the 
covered agreements.  Their failure to do so viol ated the specific prohibition to make unilateral 
determinations set out in Article 23.2(a) of the DSU.  The European Communities therefore argued that the continued suspension of concessions or ot her obligations by the United States and Canada 
constituted a violation of Article 23.2(a) read in c onjunction with Articles 21.5 and 23.1 of the DSU.   
14. In its second "series of main claims", the European Communities argued that the United 
States and Canada, by failing to have recourse to, a nd abide by, the rules and procedures of the DSU, 
violated Article 23.1 read in conjunction with Artic les 22.8 and 3.7 of the DSU.  In particular, the 
European Communities argued that Article 22.8 of the DSU prohibits the continued application of the 
suspension of concessions when the measure found to be  inconsistent is remove d.  In addition to the 
two series of main claims, the European Commun ities asserted that the continued suspension of 
concessions or other obligations by the United St ates and Canada violates Articles I and II of the 
GATT 1994.
32  Finally, the European Communiti es made an "alternative" claim33, conditional on "the 
                                                      
29Panel Report, US – Continued Suspension , para. 1.1;  Panel Report, Canada – Continued Suspension , 
para. 1.1. 
30Panel Report, US – Continued Suspension , para. 1.3;  Panel Report, Canada – Continued Suspension , 
para. 1.3.  Two separate Panels were established to examine the complaints against the United States and 
Canada, respectively;  however, the Panels were compos ed of the same panelists.  As the composition of both 
Panels was identical, in this Report we refer to the Panels collectively as the "Panel". 
31Panel Report, US – Continued Suspension , para. 7.153;  Panel Report, Canada – Continued 
Suspension , para. 7.140. 
32Panel Report, US – Continued Suspension , para. 3.1;  Panel Report, Canada – Continued Suspension , 
para. 3.1. 
33Panel Report, US – Continued Suspension , para. 7.155;  Panel Report, Canada – Continued 
Suspension , para. 7.142. WT/DS321/AB/R 
Page 8  
 
Panel find[ing] no violation of Article 23 of the DS U, ... that [the United States'/Canada's] measure[s] 
violate[] Article 22.8 of the DSU and Articles I and II of the GATT 1994."
34 
15. The United States and Canada rejected the Eur opean Communities' claims, arguing that their 
measures suspending concessions or other obligations are consistent with Article 22.8 of the DSU.  
According to the United States and Canada, the susp ension of concessions was authorized by the DSB 
and this authorization remains in effect.35  They further argued that the European Communities has 
failed to comply with the DSB's recommendations and rulings stemming from  EC – Hormones , 
because Directive 2003/74/EC is inconsistent with the   SPS Agreement , in particular, Articles 3.3, 5.1, 
and 5.7.36  The United States also alleged that the European Communities' implementing measure is 
inconsistent with Article 5.2 of the  SPS Agreement .37 
16. The Panel Reports were circulated to Members of the World Trade Organization (the "WTO") 
on 31 March 2008.  The Panel began its analysis with  the European Communities' first series of main 
claims and found that the United States and Canada "violated Article 23.1 and 23.2(a) of the DSU by 
seeking redress of a violation of the  WTO Agreement  through a determination that the [European 
Communities'] implementing measure did not comply with the DSB recommendations and rulings in 
the EC – Hormones  case without having recourse to dispute settlement in accordance with the rules 
and procedures of the DSU."38  Turning to the European Communities' second series of main claims, 
the Panel explained that the European Commun ities' "second series of main claims" and its 
"conditional" claim under Article 22.8 of the DSU were both "based on the [European Communities'] 
view that it has complied with the recomme ndations and rulings of the DSB in the  EC – Hormones  
case by adopting Directive 2003/74/EC and properly notifying it to the DSB".39  "The difference", 
according to the Panel, "is that, under the conditi onal claim, the European Communities alleges actual 
compliance, and not that it should be presumed to have complied in good faith."40  The Panel then 
observed that it "could not agree with the European  Communities and base [its] findings of violation 
of Article 23.1 read in conjunction with Artic le 22.8 and 3.7 of the DSU on an irrebuttable 
                                                      
34Panel Report, US – Continued Suspension , para. 3.2;  Panel Report, Canada – Continued Suspension , 
para. 3.2. 
35Panel Report, US – Continued Suspension , para. 4.78;  Panel Report, Canada – Continued 
Suspension , para. 4.78. 
36Panel Report, US – Continued Suspension , para. 7.180;  Panel Report, Canada – Continued 
Suspension , paras. 7.398, 7.552, and 7.826. 
37Panel Report, US – Continued Suspension , para. 7.406. 
38Panel Report, US – Continued Suspension , para. 7.251;  Panel Report, Canada – Continued 
Suspension , para. 7.244. 
39Panel Report, US – Continued Suspension , para. 7.156;  Panel Report, Canada – Continued 
Suspension , para. 7.143. (emphasis omitted)  
40Panel Report, US – Continued Suspension , para. 7.156;  Panel Report, Canada – Continued 
Suspension , para. 7.143.  WT/DS321/AB/R 
 Page 9 
 
 
presumption of good faith compliance".41  Consequently, the Panel said that it would have to 
determine whether it had jurisdiction to examine the consistency of the European Communities' 
implementing measure with the  SPS Agreement .  It concluded that it was "entitled to determine 
whether the European Communities ha s removed the measure found to be  inconsistent with a covered 
agreement in order to establish whether Articl e 22.8 has been breached" by the United States and 
Canada.42  In particular, the Panel determined that it would review the compatibility of the European 
Communities' implementing measure with Articles 5.1, 5.7, and 3.3 of the  SPS Agreement .43  In the 
case against the United States, the Panel said it w ould additionally examine the compatibility with 
Article 5.2 of the  SPS Agreement .44   
17. The Panel proceeded to examine the comp atibility of the European Communities' 
implementing measure and made the following findings.  As regards Article 5.2 in the case against the 
United States, the Panel found that "the Europ ean Communities took into account risk assessment 
techniques of the relevant international organiza tions and took into account the factors listed in 
Article 5.2 of the  SPS Agreement ."45  
18. In relation to Article 5.1 of the  SPS Agreement , the Panel found: 
[T]he Opinions do not constitute  a risk assessment because the 
Opinions do not satisfy the definition of a risk assessment contained 
in Annex A(4) second sentence and because the scien tific evidence 
referred to in the Opinions does not support the conclusions therein.  Because the Opinions are not a risk assessment as appropriate to the circumstances, the measure cannot be based on a risk assessment 
within the meaning of Article 5.1.
46 (footnote omitted) 
In light of the above, the Panel concludes that the [European 
Communities'] implementing measure on oestradiol-17 β is not 
compatible with Article 5.1 of the  SPS Agreement .47   
19. In respect of Article 5.7 of the  SPS Agreement , the Panel found: 
[I]t has not been demonstrated th at relevant scientific evidence was 
insufficient, within the meaning of Article 5.7 of the  SPS Agreement , 
                                                      
41Panel Report, US – Continued Suspension , para. 7.359;  Panel Report, Canada – Continued 
Suspension , para. 7.357. 
42Panel Report, US – Continued Suspension , para. 7.372;  Panel Report, Canada – Continued 
Suspension , para. 7.369. 
43Panel Report, US – Continued Suspension , para. 7.411;  Panel Report, Canada – Continued 
Suspension , para. 7.402. 
44Panel Report, US – Continued Suspension , para. 7.410. 
45Ibid., para. 7.573. 
46Panel Report, US – Continued Suspension , para. 7.578;  Panel Report, Canada – Continued 
Suspension , para. 7.548. 
47Panel Report, US – Continued Suspension , para. 7.579;  Panel Report, Canada – Continued 
Suspension , para. 7.549. WT/DS321/AB/R 
Page 10  
 
in relation to any of the five hormones with respect to which the European Communities applies a provisional ban.
48 
We therefore conclude that the [European Communities'] compliance 
measure does not meet the require ments of Article 5.7 of the 
SPS Agreement  as far as the provisional ban on progesterone, 
testosterone, zeranol, trenbolone acetate and melengestrol acetate is 
concerned.49 
20. The Panel refrained from making fi ndings on Article 3.3 of the  SPS Agreement , explaining 
that, "[i]n light of our mandate and of our objectives in engaging in a review of the conformity of the 
[European Communities'] implementing measure with the  SPS Agreement , we see no reason to reach 
a conclusion on Article 3.3 of the  SPS Agreement , to the extent that this conclusion depends on a 
violation of Article 5."50 
21. Having concluded its analysis under the  SPS Agreement , the Panel made the following 
findings in respect of the European Co mmunities' second series of main claims: 
[W]e conclude that it has not b een established that the European 
Communities has removed the measure found to be inconsistent with 
a covered agreement.51 
For these reasons and those developed above, we find that the 
European Communities did not demonstrate a breach of Article 22.8 of the DSU by [the United States and Canada].
52 
The Panel recalls its understanding th at violations of Articles 23.1 
and 3.7 were only claimed in relati on to the violation of Article 22.8 
of the DSU.  To the extent that  Article 22.8 has not been breached, 
the European Communities has not  established a violation of 
Articles 23.1 and 3.7 of the DSU.  The Panel concludes that there is no violation of Articles 23.1 and 3.7 of the DSU by [the United 
States and Canada] as a result of a breach of Article 22.8.
53 
                                                      
48Panel Report, US – Continued Suspension , para. 7.835;  Panel Report, Canada – Continued 
Suspension , para. 7.821. 
49Panel Report, US – Continued Suspension , para. 7.836;  Panel Report, Canada – Continued 
Suspension , para. 7.822. 
50Panel Report, US – Continued Suspension , para. 7.845;  Panel Report, Canada – Continued 
Suspension , para. 7.830. 
51Panel Report, US – Continued Suspension , para. 7.847;  Panel Report, Canada – Continued 
Suspension , para. 7.832. 
52Panel Report, US – Continued Suspension , para. 7.850;  Panel Report, Canada – Continued 
Suspension , para. 7.835. 
53Panel Report, US – Continued Suspension , para. 7.851;  Panel Report, Canada – Continued 
Suspension , para. 7.836.  WT/DS321/AB/R 
 Page 11 
 
 
22. The Panel also rejected the European Commun ities' claims under Articles I:1 and II of the 
GATT 1994.54  Finally, the Panel addressed the European Communities' alternative claim of violation 
of Article 22.8 of the DSU:  
We recall that the European Communities also raised a conditional  
claim of violation of Article 22.8 of the DSU per se.   The European 
Communities specified in its first written submission that this claim 
was "made in the alternative and only on the condition that the Panel 
does not establish any violation under Articles 23.1, 23.2(a), 3.7, 22.8 and 21.5 of the DSU". 
We note that we have established a violation of Article 23.1 
and 23.2(a).  We also recall that we have already addressed the 
alleged violation of Article 22.8 of the DSU as part of our review of 
the [European Communities'] claim of violation of Article 23.1 read together with Article 22.8 and Article 3.7 of the DSU.  Under those circumstances, it is not necessary for the Panel to address the conditional claim of violation [of] 22.8 of the DSU per se  in the 
alternative.
55 (original emphasis;  footnote omitted) 
23. On the basis of the above, the Panel conclude d that the United States and Canada had made 
the following "procedural violations": 
(a)  by seeking, through the measure at issue—that is the 
suspension of concessions or other obligations subsequent to the 
notification of the [European Communities'] implementing measure 
(Directive 2003/74/EC)—the redress of a violation of obligations under a covered agreement without having recourse to, and abiding 
by, the rules and procedures of the DSU, [the United States and Canada have] breached Article 23.1 of the DSU; 
(b)  by making a determination within the meaning of 
Article 23.2(a) of the DSU to the effect that a violation had occurred 
without having recourse to dispute settlement in accordance with the 
rules and procedures of the DSU, [the United States and Canada have] breached Article 23.2(a) of the DSU.
56 
24. As regards the European Communities' claims  concerning Article 23.1 of the DSU, read 
together with Articles 22.8 and 3.7, the Panel concluded:  
(a)  to the extent that the measure found to be inconsistent with 
the SPS Agreement  in the EC – Hormones  dispute [(WT/DS26, 
WT/DS48)] has not been removed by the European Communities, 
                                                      
54Panel Report, US – Continued Suspension , para. 7.853;  Panel Report, Canada – Continued 
Suspension , para. 7.838. 
55Panel Report, US – Continued Suspension , paras. 7.854 and 7.855;  Panel Report, Canada – 
Continued Suspension , paras. 7.839 and 7.840. 
56Panel Report, US – Continued Suspension , para. 7.856;  Panel Report, Canada – Continued 
Suspension , para. 7.841. WT/DS321/AB/R 
Page 12  
 
[the United States and Canada have] not breached Article 22.8 of the DSU; 
(b)  to the extent that Article  22.8 has not been breached, the 
European Communities has not established a violation of Articles 23.1 and 3.7 of the DSU as a result of a breach of 
Article 22.8 .
57 (original emphasis) 
25. In the light of its conclusions, the Panel r ecommended that the DSB request the United States 
and Canada to bring their measures into conf ormity with their obligations under the DSU.58  T h e  
Panel made the following additional remarks and suggestion pursuant to Article 19.1 of the DSU 
regarding the implementation of  its findings and conclusions: 
Whereas it is for the  Members to decide on the appropriate steps 
needed to bring measures found in breach of their WTO obligations into conformity, the Panel deems it important to recall its conclusion 
in [paragraph 7.251 in US – Continued Suspension  and 
paragraph 7.244 in Canada – Continued Suspension ] as the parties 
have apparently diverging opinion s as to how this report should be 
implemented by the respondent.  As already mentioned, while the Panel performed functions similar to  that of an Article 21.5 panel, 
this was done only in order to dete rmine whether Article 22.8 of the 
DSU had been breached.  This Panel was not called upon,  nor does it 
have jurisdiction, to determine the compatibility of Directive 2003/74/EC with the covered agreements.  In that context, 
the Panel suggests that, in order to implement its findings under Article 23 and in order to ensure the prompt settlement of this 
dispute, [the United States and Ca nada] should have recourse to the 
rules and procedures of the DSU without delay.
59 
26. On 29 May 2008, the European Communities notif ied the DSB, pursuant to Article 16.4 of 
the DSU, of its intention to appeal certain i ssues of law covered in the Panel Reports in US – 
Continued Suspension  and Canada – Continued Suspension  and certain legal interpretations 
developed by the Panel and filed a single Notice of Appeal60, pursuant to Rule 20 of the Working 
Procedures for Appellate Review61 (the " Working Procedures ").   
27. In a letter dated 30 May 2008, the Division noted that, in the interests of "fairness and orderly 
procedure", as referred to in Rule 16(1) of the  Working Procedures , and in agreement with the 
participants, the appellate proceedings in respect of the European Communities' appeal from the Panel
                                                      
57Panel Report, US – Continued Suspension , para. 7.857;  Panel Report, Canada – Continued 
Suspension , para. 7.842. 
58Panel Report, US – Continued Suspension , para. 8.2;  Panel Report, Canada – Continued Suspension , 
para. 8.2. 
59Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued Suspension , 
para. 8.3. 
60WT/DS320/12, WT/DS321/12 (attached as Annex I to this Report). 
61WT/AB/WP/5, 4 January 2005.  WT/DS321/AB/R 
 Page 13 
 
 
Reports in US – Continued Suspension  and Canada – Continued Suspension  would be consolidated 
due to the substantial overlap in the content of th e disputes.  A single Division would hear and decide 
the appeals, and a single oral hearing would be held by the Division.62  The participants were further 
informed that Appellate Body Member, Mr. Georg es Abi-Saab, had been selected, on the basis of 
rotation, to serve on the Division hearing these app eals, and that, in accordance with Rule 15 of the 
Working Procedures , the Appellate Body had notified the Chairman of the DSB of its decision to 
authorize Mr. Abi-Saab to complete the dispos ition of the appeals even though his second term as 
Appellate Body Member was due to expire before  the completion of the appellate proceedings.   
28. On 5 June 2008, the European Commun ities filed an appellant's submission.63  
On 10 June 2008, the United States and Canada each notified the DSB, pursuant to Article 16.4 of the 
DSU, of its intention to appeal certain issues of law covered in the respective Panel Report and certain 
legal interpretations developed by the Panel and filed a Notice of Other Appeal64, pursuant to 
Rule 23(1) and (2) of the  Working Procedures .  On 13 June 2008,  the United States and Canada each  
filed an other appellant's submission.65  On 26 June 2008, Canada, the European Communities, and 
the United States each filed an appellee's submission66, and Australia, Brazil, New Zealand, and 
Norway each filed a third participant's submission.67  On the same day, China, India, Mexico, and the 
Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu each notified the Appellate B ody 
Secretariat of its intention to appear at  the oral hearing as a third participant.68 
29. After consultation with the Appellate Body S ecretariat, Canada, the European Communities, 
and the United States each agreed that it would not be  possible for the Appellate Body to circulate its 
Reports in these appeals within the 90-day time- limit referred to in Article 17.5 of the DSU.69  
Canada, the European Communities, and the United States agreed that additional time was needed 
because of the preliminary procedural issue arising in these proceedings, the size of the Panel record, 
the number and complexity of the issues appealed , and the fact that there was another appellate
                                                      
62At the oral hearing, the United States and Cana da confirmed their preference for two separate 
Appellate Body reports.  We have issued separate reports (WT/DS320/AB/R and WT/DS321/AB/R), which are 
identical except for the Findings and Conclusions section. 
63Pursuant to Rule 21 of the Working Procedures . 
64WT/DS320/13 (attached as Annex II to this Report) ;  WT/DS321/13 (attached as Annex III to this 
Report). 
65Pursuant to Rule 23(3) of the Working Procedures . 
66Pursuant to Rules 22 and 23(4) of the Working Procedures .  After consultation with the participants, 
the Division hearing this appeal allocated additional time for filing the appellees' submissions and the third participants' submissions and notifications, pursuant to Rules 16, 22, 23, 24, and 26 of the  Working Procedures . 
67Pursuant to Rule 24(1) of the Working Procedures . 
68Pursuant to Rule 24(2) of the Working Procedures . 
69Letter from the European Commission to the Di rector of the Appellate Body Secretariat 
dated 11 July 2008;  Letter from Canada to the Director of the Appellate Body Secretariat dated 15 July 2008;  
Letter from the United States to the Director of the Appellate Body Secretariat dated 17 July 2008. WT/DS321/AB/R 
Page 14  
 
proceeding running simultaneously.  Accordingly,  Canada, the European Communities, and the 
United States each confirmed that it would deem the Appellate Body Reports in these proceedings, 
issued no later than 16 October 2008, to be Appellate  Body reports circulated pursuant to Article 17.5 
of the DSU.
70 
30. On 27 June 2008, the European Communities sen t a letter to the Appellate Body Secretariat 
noting that the United States and Canada had filed their appellee's submissions after the 5:00 p.m. 
time-limit set out by the Division in the Working Schedule drawn up for these appeals.  The European 
Communities referred to Rule 18(1) of the  Working Procedures  and requested that the Division 
"inform the parties of the treatment that should be accorded to these documents".71  The United States 
and Canada responded in separate letters and re quested the Division to reject the European 
Communities' request.72  At the oral hearing, the Division gave a ruling on the European 
Communities' request regarding the late filing of the appellee's submission by the United States and 
Canada.  The Division emphasized the importance of all participants adhering strictly to the time-
limits set out in the Working Schedule, given the time constraints imposed upon both the participants 
and the Appellate Body Members in these proceedings.  It also noted that the failure to strictly 
observe such time-limits can have an impact upon the fairness and the orderly conduct of the 
proceedings.  However, having thor oughly examined the matter, and in the light of the particular 
time-limits concerned and potential prejudice th at might be involved, the Division decided 
nevertheless to consider the appellees' submis sions filed by the United States and Canada. 
31. Canada, the European Communities, and the United States requested, on 3 June 2008, that the 
Division authorize public observation of the oral hearing.  They argued that public observation of the oral hearing was not precluded by the DSU, the  Working Procedures , or the  Rules of Conduct for the 
                                                     
 
70On 22 July 2008, the Appellate Body notified the Chairman of the DSB that  the expected date of 
circulation of its Report was 16 October 2008 (WT/DS320/14, WT/DS321/14). 
71Letter from the European Commission to the Direct or of the Appellate Body Secretariat dated 
27 June 2008. 
72Letter from Canada to the Director of the Appella te Body Secretariat dated 30 June 2008;  Letter 
from the United States to the Director of the Appellate Body Secretariat dated 1 July 2008.  Canada noted that 
the European Communities' appellee's submission sent via email was also slightly delayed.  The United States 
noted that the European Communities announced in an email message that it had delivered printed copies of its 
appellee's submission to the Appellate Body Secretariat and to the other participants and third participants 
before 5 p.m.;  however, the United St ates received the electronic copy of  the European Comm unities' appellee's 
submission after 5 p.m., whereas the Working Schedule st ates that "[t]welve printe d copies, as well as an 
electronic copy, of each written su bmission should be filed by 5 p.m., Geneva, Switzerland time,  on the due date 
indicated in this Working Schedule". (original underlining)  In the event the Appellate Body were to rule on the European Communities' request regarding the United States' appellee's submission, the United States requested 
the Appellate Body also to inform the European Communities of the treatme nt to be accorded to its submission 
in the light of Rule 18 of the  Working Procedures .  WT/DS321/AB/R 
 Page 15 
 
 
Understanding on Rules and Procedures Governing the Settlement of Disputes73 (the " Rules of 
Conduct ").  The participants proposed various logis tical arrangements that would allow public 
observation, while respecting the confidentiality of any third participants that did not wish to disclose 
their oral statements or responses to questions.74  On 4 June 2008, the Division invited the third 
participants to comment in writing on the par ticipants' request to open the hearing to public 
observation.  In particular, the Division asked for th e third participants' views on the permissibility of 
opening the hearing for public observation under the DSU and the  Working Procedures , and, if they 
so wished, on the specific logistical arrangements proposed in the requests.  Comments were received, 
on 12 June 2008, from Australia, Brazil, China, I ndia, Mexico, New Zealand, Norway, and the 
Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu.  Australia, New Zealand, 
Norway, and the Separate Customs Territory of  Taiwan, Penghu, Kinmen and Matsu supported the 
participants' request to open the hearing to public  observation.  Brazil, China, India, and Mexico 
requested the Appellate Body to deny the participan ts' request.  According to these third participants, 
the oral hearing forms part of the proceedings of th e Appellate Body and, therefore, is subject to the 
requirement of Article 17.10 of the DSU that "[t] he proceedings of the Appellate Body shall be 
confidential".  On 16 June 2008, the Division i nvited Canada, the European Communities, and the 
United States to comment on the submissions made by  the third participants.  Third participants who 
wished to submit comments on the submissions made by  the other third participants were also invited 
to do so.  Additional comments from Canada, the Eu ropean Communities, and the United States were 
received on 23 June 2008.  On 7 July 2008, the Divisi on held an oral hearing with the participants and 
third participants, exclusively dedicated to expl oring the issues raised by the request of the 
participants to authorize public observation.  The participants and third pa rticipants made oral 
statements and responded to questions from the Di vision.  At the end of the oral hearing, the 
participants and third participants  were invited to submit, by close of business, 8 July 2008, additional 
comments relating specifically to the technical mo dalities proposed by the participants for public 
observation.  Comments were received from Brazil, China, India, and Mexico, as well as Canada, the 
European Communities, and the United States. 
32. On 10 July 2008, the Division issued a Procedural Ruling in which it authorized the public 
observation of the oral hearing and adopted additi onal procedures for that pu rpose in accordance with 
Rule 16(1) of the  Working Procedures .  The Procedural Ruling is attached as Annex 4 of this Report.  
Public observation took place via simultaneous clos ed-circuit television broadcast to a separate room.  
                                                      
73The Rules of Conduct , as adopted by the DSB on 3 D ecember 1996 (WT/DSB/RC/1), are 
incorporated into the Working Procedures (WT/AB/WP/5), as Annex II thereto. (See WT/DSB/RC/2, 
WT/AB/WP/W/2)   
74The participants expressed a prefer ence for simultaneous closed-circu it broadcast to a separate room. WT/DS321/AB/R 
Page 16  
 
Notice of the opening of the hearing to public obser vation and registration inst ructions were provided 
on the WTO website.  A total of 80 individuals registered to observe the oral hearing. 
33. The oral hearing took place on 28-29 July 2008.  Pursuant to the additional procedures 
adopted by the Division, Canada, the European Co mmunities, and the United States were authorized 
to disclose their oral statements and responses to questions.  Australia, New Zealand, Norway, and the 
Separate Customs Territory of Ta iwan, Penghu, Kinmen and Matsu were also authorized to disclose 
their statements and responses to questions.  The or al statements and responses to questions of the 
other third participants were not s ubject to observation by the public.   
II. Arguments of the Participants  and the Third Participants 
A. Claims of the European Communities – Appellant  
1. Procedural Issue – Public Observation of the Oral Hearing 
 
34. The European Communities requested the Appella te Body to allow public observation of the 
oral hearing in these proceedings.  The European  Communities recognizes that Article 17.10 of the 
DSU provides that "[t]he proceedings of the Appellate  Body shall be confidential".  Nevertheless, for 
the European Communities, "it is by  no means obvious that the term 'proceedings' covers the oral 
hearing of the Appellate Body."75  The European Communities submits  that "an interpretation of the 
ordinary meaning of that term in its context and in light of the DSU's object and purpose will 
demonstrate that '[t]he proceedings of the Appella te Body' rather refers to the Appellate Body's 
internal work, and does not include its oral hearing, and that Article 17.10 in any event does not prohibit an open oral hearing."
76 
35. The European Communities acknowledges that Article 14.1 of the DSU refers to the 
"deliberations" of the panel as being confidential.   However, the European  Communities argues that 
the choice of the different words "deliberations" a nd "proceedings" may be explained by the fact that 
the idea of creating an Appellate Body emerged relati vely late in the negotiations on the DSU, and the 
fact that the DSU regulates the appellate review in much more rudimentary terms than the panel 
procedure.  Therefore, the European Communities finds no basis for understanding the choice of the 
different words "deliberations" and "proceedings" as reflecting an intention to draw a difference for 
the question at issue, and to rule out public ob servation of Appellate Body oral hearings.  The 
European Communities also refers to  the French and Spanish versions of Article 17.10 that use the 
terms " travaux " and " actuaciones ", respectively.  The European Communities states that these are 
                                                      
75European Communities' request for an open hearing, para. 9. 
76Ibid.  WT/DS321/AB/R 
 Page 17 
 
 
"very broad terms that could cover every work whic h the Appellate Body performs", but that such a 
literal reading "would give rise to absurd results".77  Thus, these terms have to be given a "more 
plausible meaning"78 and are best understood as capturing the internal work of the Appellate Body. 
36. According to the European Communities, interp reting "proceedings" more broadly than "the 
internal work of the Appellate Body" leads to probl ematic results.  First, the oral hearing would be 
confidential with "the absurd result ... that the pa rties themselves could not attend the hearing in their 
own dispute".79  Secondly, it would preclude the Appellate  Body from referring to the arguments of 
the participants in the Appellate Body report.  Thir dly, the Notices of Appeal could not be circulated 
to WTO Members and made public.   
37. The European Communities asserts that, if  the Appellate Body was "empowered"80 by 
Article 17.9 of the DSU to draw up its  Working Procedures  and thereby to create the "oral hearing", 
even though an oral hearing is not foreseen in the DS U, it is also entitled to hold an oral hearing that 
is open for public observation.  The European Co mmunities submits that allowing public observation 
of the oral hearing "gives effect to the choice which the DSU offers to the parties"81 under Article 18.2 
of the DSU, which provides that "[n]othing in [the  DSU] shall preclude a party to a dispute from 
disclosing statements of its own positions".  Mo reover, the European Communities states that, in 
accordance with Article 3.7 of the DSU, the objec tive of the WTO dispute settlement mechanism is 
"to secure a positive solution to a dispute".  It follows that if the parties to a dispute jointly consider 
that an open hearing is an important part of th eir desired way to find a positive solution of their 
dispute, then it is in line with the object a nd purpose of the DSU to accommodate that request. 
38. The European Communities maintains that c onfidentiality under the DSU is correctly 
understood as protecting the interests of WTO Member s where they consider that they need that 
protection, and not as an obligation imposed , even where WTO Members do not desire 
confidentiality.  The European Communities adds that  "[t]he other function of confidentiality is to 
protect the integrity of the (quasi-)judicial process, bu t in contrast to secret deliberations, this function 
does not require closed hearings."82  On the contrary, the Europ ean Communities argues that open 
hearings are even better and more natural for th e judicial process, as the tradition of open oral 
hearings in national and international judiciaries around the world demonstrates. 
                                                      
77European Communities' request for an open hearing, para. 15. 
78Ibid. 
79Ibid., para. 19. 
80Ibid., para. 25. 
81Ibid., para. 26. (emphasis omitted) 
82Ibid., para. 31. WT/DS321/AB/R 
Page 18  
 
39. Finally, the European Communities submits th at the Appellate Body should follow the 
example of the Panel in these proceedings and of other panels which have allowed public observation 
of their meetings with the parties.  The Eur opean Communities additionally refers to various 
international courts and tribunals that a llow the public to observe their hearings. 
40. The European Communities rejects the arguments made by the third participants that oppose 
the request to open the hearing on the basis of their interpretation of the scope of the term 
"proceedings".  The European Communities stat es that none of these third participants "has 
commented on the many inconsistencies that would ar ise out of such a reading ..., not least the fact 
that the confidentiality requirement obviously does not apply to certain other aspects of the 'proceedings' in a broad sense (such as the notice of  appeal, the disclosure of statements in the 
report etc. ... )."
83  The European Communities al so rejects the relevance of the interpretation of the 
term "proceedings" in Canada – Aircraft , because that case involved a different issue, namely, 
whether additional procedures were necessary for the protection of business confidential information.  
As regards Article 18.2 of the DSU, the European  Communities considers that this provision "trumps 
any confidentiality requirements that may exist elsewhere in the agreement"84, rather than vice-versa, 
as suggested by some third participants.  More over, the European Communities disagrees with the 
argument that the Appellate Body's decision in this  case will prejudge the outcome of the DSU review 
negotiations. 
41. For these reasons, the European Communities re quests the Appellate Body to allow public 
observation of the hearing in these proceedings.  Th e European Communities st ates that its preferred 
format is to allow public observation of the Appellate Body's oral hearing "by way of real-time closed-circuit audio and video broadcast to a separate room".
85 
2. Articles 23.2(a) and 21.5 of the DSU  
42. Although it agrees with the Panel's finding that  the United States and Canada have acted 
inconsistently with Articles 23.2(a) and 23.1 of the DSU, the European Co mmunities asserts that the 
Panel erred by failing to find that Article 23.2(a), read together with Articles 21.5 and 23.1, required 
the United States and Canada to initiate Article  21.5 proceedings if they considered that 
Directive 2003/74/EC did not comply with th e DSB's recommendations and rulings in EC – 
Hormones .  
                                                      
83European Communities' comments on third participants' comments, para. 4. 
84Ibid., para. 10. 
85European Communities' request for an open hearing, para. 45.  WT/DS321/AB/R 
 Page 19 
 
 
43. According to the European Communities, when a WTO Member considers that the 
implementing measure taken by another WTO Member is not consistent with the covered agreements, 
and proceeds to enforce what it considers to be its rights under the DSU, that Member is obliged first 
to have recourse to a compliance procedure under Article 21.5 of the DSU.  The European Communities asserts that "a WTO Member is not ent itled, in these circumstances, to seek the redress 
of an alleged violation through the suspension of  obligations without first having recourse to a 
compliance procedure."
86   
44. In the view of the European Communities, the Panel confused the question of whether 
recourse to Article 21.5 is obligatory and the question of what procedures are available under 
Article 21.5.  The European Communities disagrees  with the Panel's interpretation of the phrase 
"except through recourse to dispute settlement in ac cordance with the rules and procedures of this 
Understanding" in Article 23.2(a) as "encompassing any of the means of dispute settlement provided 
in the DSU, including consultation, conciliation, good offices and mediation".87  According to the 
European Communities, "[i]t is not in dispute"88 that the United States and Canada disagree with the 
European Communities as to the consiste ncy of Directive 2003/74/EC with the  SPS Agreement .  
Consequently, the present dispute "clearly" falls with in the scope of Article 21.5 because it concerns a 
"disagreement as to the existence or consistency with a covered agreement of measures taken to 
comply with the recommendations and rulings"89 of the DSB in EC – Hormones .  The European 
Communities emphasizes that consultation, concilia tion, good offices, and mediation under the DSU 
have no effect unless the results are accepted by the parties.  In this dispute, the European 
Communities argues, "it is manifest that no procedure requiring the agreement between the parties was available"
90, because the European Communities exhaus ted all available options, including 
arbitration under Article 25 of the DSU, in its a ttempt to come to an agreement with the responding 
parties.  The European Communities submits that  the phrase "shall be decided through recourse to 
these dispute settlement procedures, including wherever  possible resort to the original panel" in 
Article 21.5 implies an obligation to have recourse to compliance panel proceedings and that, in the 
absence of an amicable solution, there must be a final and binding ruling by an adjudicative body.  
The European Communities concludes from this that  "Article 21.5 of the DSU is the applicable 
provision because the WTO members clearly privileged that provision in case of disagreement 
between the parties on implementation".91  Thus, the European Commun ities maintains that the Panel 
                                                      
86European Communities' appellant's submission, para. 57. 
87Ibid., para. 48 (referring to Panel Report, US – Continued Suspension , para. 7.247;  and Panel Report, 
Canada – Continued Suspension , para. 7.240). 
88European Communities' appellant's submission, para. 59. 
89Ibid., para. 49. 
90Ibid., para. 54. 
91Ibid., para. 61. WT/DS321/AB/R 
Page 20  
 
erred in failing to draw the necessary conclusion th at an Article 21.5 pane l proceeding was the only 
applicable procedure available under the DSU and th at such a panel procedure was "the only way for 
the United States and Canada to proceed".
92  
45. The European Communities argues furthermore that the Panel erred in finding that 
compliance panel proceedings may be initiated by the European Communities as the original 
responding party in EC – Hormones .  On the contrary, the European Communities submits, it is 
inherent in the wording, context, and object and pur pose of the provision that the original complaining 
parties, that is, the United States and Canada, are required to have r ecourse to Article 21.5.93  The 
European Communities maintains that  references in Articles 3.12, 4.4, 4.7, and 6 of the DSU to 
"complaining party" and "complainant" confirm that  the WTO dispute settlement system is based on 
the notion of "adversarial proceedings" and "is not ap plicable to requests for an abstract confirmation 
of the  consistency  of a measure"94 by the defending party.  Thus, where a complaining party alleges 
that an implementing measure is not consistent with the covered agreements, the "implementing 
Member cannot have recourse to Article 21.5 of the DSU in order to confirm the WTO-consistency of 
its compliance measure."95  The European Communities asserts that this understanding is confirmed 
by the very notion of the DSU as a "dispute" settleme nt system and by the basic logic reflected in 
Article 3.3 of the DSU and Article XXIII:2 of the GATT 1994, which assumes a situation where a 
WTO Member considers that its rights are being impa ired by another Member's measure and therefore 
challenges that measure, and "does not address the situation where a Member is complaining against 
its own measure".96   
46. The European Communities additionally contends that "[i]t would be manifestly impossible 
for the European Communities to fu lfil the very basic requirements of Article 6" as regards the 
content of the request for the establishment of a pa nel, because "it would not be in a position to 
identify the provisions of the  SPS Agreement  that are violated."97  Moreover, the European 
Communities maintains that compliance panel pro ceedings initiated by the European Communities 
would not lead to recommendations addressed to th e retaliatory measures taken by the United States 
and Canada, because these measures are not the measu re taken to comply with respect to which a 
disagreement exists within the meaning of Article 21.5.  The European Commu nities also points out 
that an original complainant may refuse to partic ipate in compliance panel proceedings initiated by 
the original respondent, as in fact occurred in EC – Bananas III (Article 21.5 – EC) .  The European 
                                                      
92European Communities' appellant's submission, para. 55. 
93See ibid., para. 75. 
94Ibid., para. 78. (original emphasis) 
95Ibid., para. 78. 
96Ibid., para. 85. 
97Ibid., para. 88.  WT/DS321/AB/R 
 Page 21 
 
 
Communities considers that the "subsequent practice"98 that has developed in the WTO dispute 
settlement system confirms its understanding that Artic le 21.5 is only available to complaining parties 
in the original dispute.  The European Commun ities points out that, since the establishment of the 
WTO, 30 out of 31 proceedings pursuant to Article  21.5 were initiated by the original complaining 
party, and the panel report in the one remaining pr oceeding, initiated by the original responding party, 
was never adopted.  This demonstrates that such a procedure is not an option for the original 
responding party.  
47. On this basis, the European Communities requests the Appellate Body to reverse the Panel's 
findings that the scope of the phrase "recourse  to these dispute settlement procedures" in 
Article 23.2(a) is not limited to Article 21.5 pane l proceedings initiated, in this case, by the United 
States and Canada as the original complaining part ies, and that the European Communities, as the 
original respondent, may initia te Article 21.5 proceedings. 
3. Article 22.8 of the DSU  
48. The European Communities alleges that the Pa nel erred in finding that the European 
Communities' second series of main claims were premised on:  (i) a violation by the United States and Canada of their obligations under Article 22.8 of th e DSU;  and (ii) the actual conformity with the 
SPS Agreement  of the implementing measure taken by the European Communities.
99  In its second 
series of main claims before the Panel, the Eur opean Communities argued that  the United States and 
Canada have acted inconsistently  with Article 23.1 of the DSU, read together with Articles 22.8 
and 3.7, by maintaining the suspension of concessi ons despite the removal of the "measure found to 
be inconsistent" within the meaning of Article 22.8—that is, Directive 96/22/EC.100   
49. The European Communities explains that it neve r argued that the claim under Article 23.1 of 
the DSU was dependent on a violation of Article  22.8 by the United States and Canada and never 
argued that this claim would be premised on the conformity of the implementing measure with the 
SPS Agreement .  Rather, the violation the European  Communities claimed was the unilateral 
determination made by the United States and Cana da according to which "the measure taken to 
comply" with the recommendations and rulings of the DSB, that is, Directive 2003/74/EC, is not, in 
their view, consistent with the  SPS Agreement .  The European Communities adds that such a 
determination is a violation of Ar ticle 23.1 of the DSU read in the light of Article 22.8 of the DSU,
                                                      
98European Communities' appellant's submission, para. 91. 
99Ibid., paras. 99 and 100 (referring to Panel Report, US – Continued Suspension , para. 7.272;  and 
Panel Report, Canada – Continued Suspension , para. 7.288). 
100Panel Report, US – Continued Suspension , para. 7.252;  Panel Report, Canada – Continued 
Suspension , para. 7.245. WT/DS321/AB/R 
Page 22  
 
not a claim of violation of Article 22.8 in itself,  and is not premised on the conformity of the 
implementing measure with the  SPS Agreement .  The European Communiti es additionally notes that 
only in the alternative, and only on the condition th at the Panel did not establish any violation under 
Articles 23.1, 23.2(a), 3.7, 22.8 and 21.5 of the DSU, did the European Communities make an alternative claim under Article 22.8 of the DSU.
101 
50. The European Communities asserts that the Pa nel "fail[ed] to provide any serious legal 
argumentation"102 as to why, under Article 22.8, what is to be achieved is not the removal of the 
measure, but actual compliance with the DSB' s recommendations and rulings.  The European 
Communities takes issue with the Panel's finding that the replacement of Directive 96/22/EC by Directive 2003/74/EC did not constitu te the removal of the inconsiste nt measure within the meaning 
of Article 22.8, because Directive 2003/74/EC, like its predecessor, imposes an import ban on meat 
treated with hormones.  According to the European  Communities, this finding contradicts the Panel's 
earlier finding that "it is not the ban on meat trea ted with growth promotion hormones as such that 
was found illegal in the EC – Hormones  case, but the justification for this ban which was found 
insufficient."
103  Moreover, the European Communities underscores the Panel's finding that 
Directive 2003/74/EC "shows all the signs of an implementing measure having gone through all the 
formal process required for its adop tion and showing, on its face, all th e signs of a measure adopted in 
good faith."104  The European Communities contends that, because the Panel concluded that 
Directive 96/22/EC—the measure found to be inc onsistent with a covered agreement—has been 
removed, it follows from the wording of Article 22.8 that the application of the suspension of 
concessions was no longer authorized after the adoption and the subsequent notification of 
Directive 2003/74/EC to the DSB.  The European Communities also emphasizes that Articles 3.7 and 22.8 both recognize that the suspension of co ncessions or other obligations is a temporary 
measure of last resort.
105   
51. The European Communities emphasizes that Artic le 22.8 refers to whether the "measure 
found to be inconsistent with a covered agreement" has been rem oved.  The European Communities 
asserts that, in this particular case, the measure found to be inconsistent within the meaning of 
Article 22.8 was the measure that was subject to the original dispute in EC – Hormones  and that was 
                                                      
101European Communities' appellant's submission, para. 97.  
102Ibid., para. 105. 
103Ibid., para. 106 (quoting Panel Report, US – Continued Suspension , para. 7.207;  and Panel Report, 
Canada – Continued Suspension , para. 7.199). (emphasis omitted) 
104Ibid., para. 108 (quoting Panel Report, US – Continued Suspension , para. 7.238;  and Panel Report, 
Canada – Continued Suspension , para. 7.231). (emphasis omitted) 
105Ibid., paras. 115 and 116.  The European Communities also refers to its own conduct in US – FSC , 
where it suspended the application of retaliatory measur es and initiated an Article 21.5 proceeding because it 
considered the United States' implemen ting measure to be inconsistent with the relevant covered agreements. 
(Ibid., para. 156)  WT/DS321/AB/R 
 Page 23 
 
 
identified by the Appellate Body as the measu re found to be inconsistent with the  SPS Agreement  
in 1998.  That measure was Directive 96/22/EC .  Thus, once the European Communities adopted 
Directive 2003/74/EC, which was based on a new risk assessment that explicitly aimed at addressing 
the shortcomings found in EC – Hormones  with respect to Directive 96/22/EC, the suspension of 
concessions or other obligations could no longer be applied.  Once the original measure was removed, 
the suspension of concessions would continue w ithout its main objective—implementation of the 
DSB's recommendations and rulings—because the impl ementing measure had already been taken.  
The objective to induce compliance could only "reviv e after it has been properly established before a 
compliance procedure under Article 21.5 of the DSU that the implementing measure has been insufficient to remedy a WTO violation."
106   
52. The European Communities contends that "Artic les 21 and 22 of the DSU [were] ... drafted 
around a basic dichotomy between 'the measure found to be inconsistent' and the 'measures taken to 
comply'."107  Therefore, "whether the measure taken [b y the European Communities] to comply is 
compliant with the recommendations and rulings of the DSB"108 is a matter to be determined by a 
panel acting under Article 21.5 of the DSU.  Unlike Article 21.5, Article 22.8 refers to whether the 
measure has been removed and does not refer to whet her the measure taken to comply is consistent 
with the DSB's recommendations and rulings.  Th e European Communities adds that interpreting 
Article 22.8 as referring to "actual compliance", as the Panel did, would allow the original complaining Member to make a unilateral determin ation of the substantive merits of the measure 
taken to comply without recourse to Article 21.5 of the DSU. 
53. The European Communities considers that the Pa nel "fundamentally erred" in the manner in 
which it identified the "measure found to be incons istent with a covered agreement" in order to 
determine whether it "has been removed"
109 within the meaning of Article 22.8 of the DSU.  The 
European Communities states that, even thoug h the Panel initially considered that 
Directive 96/22/EC, that is, the SPS measure subject to the original proceedings in EC – Hormones , 
was removed, the Panel later held the view that considering Directive 96/22/EC as the measure found 
                                                      
106European Communities' appellant's submission, para. 141. 
107Ibid., paras. 136 and 137 (referring to the Appellate Body's statement in paragraph 36 of its Report in 
Canada – Aircraft (Article 21.5 – Brazil)  that "a measure which has been 'taken to comply ...' ... will  not  be the 
same measure as the measure which was th e subject of the original dispute, so that, in principle, there would be 
two separate and distinct measures" (o riginal emphasis; footnote omitted)). 
108Ibid., para. 142. 
109Ibid., para. 145. WT/DS321/AB/R 
Page 24  
 
to be inconsistent with a covere d agreement within the meaning of Article 22.8 is "unsatisfactory, as 
Directive 96/22/EC was replaced by Directive 2003/74/EC which also imposes an import ban".
110 
54. For these reasons, the European Communities re quests the Appellate Body to reverse the 
Panel's finding that the European Communities' cl aims under Articles 23.1, 22.8, and 3.7 of the DSU 
were premised on a violation of Article 22.8 a nd on the actual compliance of Directive 2003/74/EC 
with the  SPS Agreement .  It also requests the Appellate Body to complete the analysis and find that 
the United States and Canada have breached Article 23.1 of the DSU by continuing the suspension of 
concessions despite the adoption and subsequent no tification to the DSB of Directive 2003/74/EC. 
4. The Panel's Terms of Reference  
55. The European Communities maintains that  its alternative claim of a "direct"111 violation of 
Article 22.8, on the basis of its actual compliance with the  SPS Agreement , was "strictly"112 
predicated on the condition that the Panel found no  violations pursuant to the European Communities' 
two series of main claims.  The European Communiti es asserts that the Panel should not have ignored 
the "hierarchy"113 and "conditional order of the legal clai ms" because it "form[ed] part of [its] 
mandate".114  The European Communities reiterates that its  second series of main claims, alleging that 
the United States and Canada have violated Article 23 .1, read together with Articles 22.8 and 3.7, did 
not depend on the presumed or actual complian ce of Directive 2003/74/EC with the DSB's 
recommendations and rulings, but were premised on the fact that the measure found to be inconsistent 
with a covered agreement, within the meaning of Ar ticle 22.8, had been removed.  Therefore, whether 
Directive 2003/74/EC complies with the  SPS Agreement  was only relevant for the European 
Communities' conditional "alternative" claim, whic h the Panel should have examined only if the 
condition that the Panel found no violation under th e European Communities' two series of main 
claims had been met.  On this  basis, the European Communities argues that the Panel ignored the 
clear indication by the European Communities as to the hierarchy and conditional order of its claims 
and exceeded its mandate by reviewing the comp atibility of Directive 2003/74/EC with the  SPS 
Agreement , even though the Panel had al ready found that the United States and Canada had breached 
Articles 23.1 and 23.2(a) of the DSU.   
                                                      
110European Communities' appellant's submission, para. 146 (quoting Panel Report, US – Continued 
Suspension , paras. 7.283 and 7.284;  and Panel Report, Canada – Continued Suspension , paras 7.299 
and 7.300). 
111Ibid., para. 160 (quoting Panel Report, US – Continued Suspension , para. 7.164;  and Panel Report, 
Canada – Continued Suspension , para. 7.151). 
112Ibid., para. 165. 
113Ibid., para. 162. 
114Ibid., para. 167.  WT/DS321/AB/R 
 Page 25 
 
 
56. The European Communities alleges that , as shown by the panel report in EC – Sardines , when 
a panel has clear indications by the complaining part y as to the order of its legal claims, it is "bound 
by the sequencing order of the legal claims"115 if such an order does not affect the proper 
interpretation of the relevant provisions of the cove red agreements.  In this dispute, the order of 
claims raised by the European Communities did not affect the proper interpretation of the relevant 
provisions of the DSU and the  SPS Agreement , and the Panel erred in failing to follow this order. 
57. The European Communities emphasizes that its  "main point in these proceedings was to 
establish that the proper place to review compliance was before an Article 21.5 panel at the request of 
the United States or Canada on the basis of explicit claims setting out their objections to the new measures."
116  It adds that, had the Panel followed the or der and conditions of the claims made by the 
European Communities, it would not have acted as a compliance panel in blatant disregard of its 
terms of reference and the very specific requirements under Article 21.5 of the DSU as informed, inter alia , by Article 6 of the DSU.  The European Communities notes, in this regard, what it 
considers to be contradictory statements by the Pa nel with respect to whether or not the Panel was 
"substitut[ing]" itself for, or "perform[ing]"
117 the role of, an Article 21.5 panel. 
58. Therefore, the European Communities asserts that  the Panel "acted ... in blatant disregard of 
[its] terms of reference and the ... re quirements under Article 21.5 of the DSU"118 and erroneously 
assumed the function of an Article 21.5 panel, in cont ravention with Articles 7 and 21.5 of the DSU.   
5. The Panel's Suggestion for Implementation  
59. The European Communities requests the Appellate Body to "modify"119 the Panel's 
suggestion that the United States and Canada "should ha ve recourse to the rules and procedures of the 
DSU without delay".120  According to the European Communiti es, as a result of the Panel's findings 
that the United States and Canada have breached Articles 23.2(a) and 23.1 of the DSU, there is 
"no doubt"121 that the continued suspension of concessions is inconsistent with the DSU, even if a 
compliance proceeding were initiated without dela y.  Consequently, the European Communities 
considers that "the United States and Canada shoul d remove their suspension of WTO obligations and
                                                      
115European Communities' appellant's submission, para. 168 (referring to Panel Report, EC – Sardines , 
paras. 7.14-7.19). 
116Ibid., para. 170. 
117Ibid., paras. 172 and 173 (referring to Panel Report, US – Continued Suspension , paras. 7.276 
and 8.3;  and Panel Report, Canada – Continued Suspension , paras. 7.292 and 8.3). (emphasis omitted) 
118Ibid., para. 171. 
119Ibid., para. 456. 
120Ibid., para. 478 (quoting Panel Report, US – Continued Suspension , para. 8.3;  and Panel Report, 
Canada – Continued Suspension , para. 8.3). 
121Ibid., para. 468. WT/DS321/AB/R 
Page 26  
 
have recourse to the rules and procedures of the DSU without delay if they continue to take issue with 
the European Communities' implementation of the recommendations"
122 stemming from EC – 
Hormones .   
60. The European Communities adds that the phr ase "through recourse to dispute settlement" in 
Article 23.2(a) requires an outcome of the recourse in  the form of binding decisions or an agreement 
between the parties.  Thus, the European Comm unities argues, the inconsistency resulting from the 
continued suspension of concessions will not disapp ear if the United States and Canada merely 
request consultations or initiate mediation procedur es.  Instead, the United States and Canada must 
"complete"123 Article 21.5 proceedings against the European Communities.  The European 
Communities further submits that it "would be deprived  of the protection of Article 23 of the DSU, if 
[it] can secure the withdrawal of the sanctions only by winning in the compliance dispute brought by the United States and Canada, as suggested by the Panel."
124  In the European Communities' view, 
Article 23 would be "turned on its head"125 if a WTO Member were allowed to make first a unilateral 
determination—by keeping the susp ension of concessions in place—that an implementing measure of 
another Member is WTO-inconsis tent, and only later obtain multilat eral findings in proceedings 
initiated by the implementing Member that pr ovide a valid basis for the determination. 
61. The European Communities states that the circumstances of this dispute require "clarity" and 
a suggestion by the Appellate Body would be "very useful"126, explaining that the Panel's suggestion 
is "too vague to be of much assistance".127  Thus, the European Comm unities requests the Appellate 
Body to "improve"128 the Panel's suggestion so as to make it clear that the United States and Canada 
must cease applying the suspension of concessions , and must seek resolution of any remaining 
disagreement concerning the consistency with the  SPS Agreement  of Directive 2003/74/EC by 
having recourse to Article 21.5 panel proceedings or  any other proceeding to which the parties may 
agree. 
6. The Panel's Selection of Experts  
62. The European Communities takes issue with  the Panel's selection of two experts—
Dr. Jacques Boisseau and Dr. Alan Boobis—who contri buted to the reports by JECFA regarding the 
use of the hormones at issue in this dispute.  Th e European Communities claims that "any 'reliance' 
                                                      
122European Communities' appellant's submission, para. 454.   
123Ibid., para. 461. 
124Ibid., para. 475. 
125Ibid., para. 476. (emphasis omitted) 
126Ibid., para. 477. 
127Ibid., para. 479. 
128Ibid., para. 480.  WT/DS321/AB/R 
 Page 27 
 
 
the Panel[] [has] placed on what these two experts from JECFA said is a violation of the relevant rules 
on conflict of interest, of its rights of due process an d of the requirement for the Panel[] to perform an 
'objective assessment' of the matter before [it]"129, as required under Article 11 of the DSU.   
63. Recalling the Appellate Body's finding in Thailand – H-Beams  that the "requirement of due 
process is fundamental to ensuring a fair and or derly conduct of dispute settlement proceedings"130, 
the European Communities posits that due pr ocess "informs the entire Dispute Settlement 
Understanding".131  In the view of the European Communities, "the consultation of experts by the 
Panel[] for the purposes of scientific and technical advice including their selection must respect general principles of law, and in par ticular the principle of due process."
132  The European 
Communities adds that "[i]t is inherent in the princi ple of due process that the parties to a dispute are 
given a fair hearing including that the experts a c ourt, tribunal or panel hears or consults are 
independent and impartial ."133   
64. The European Communities contends that "the relevant legal test"134 for evaluating whether 
an expert is independent and impart ial is found in Section VI.2 of the Rules of Conduct , which 
requires that experts "disclose any information that could reasonably be expected to be known to them 
at the time [they are requested to serve as experts] which ... is likely to affect or give rise to justifiable 
doubts as to their independence or impartiality."  The European Communities asserts that this 
standard is "quite simple and low" and " does not require certainty or high probability".135  T h e  
European Communities asserts that "the Panel[] never actually addressed the relevant legal 
question"136 of whether this standard ser ved to disqualify these experts. 
65. The European Communities alleges that th e Panel disregarded its "most important 
objection"137 that Drs. Boisseau and Boobis, who participated in the drafting of JECFA reports, could 
not be independent and impartial because they were asked to evaluate the risk assessments that were 
"very critical of the JECFA reports".138  The European Communities obser ves that as "co-authors" of 
the JECFA reports, these experts "cannot be consid ered to be independent and impartial in these 
                                                      
129European Communities' appellant's submission, para. 202. 
130Ibid., para. 184 (quoting Appellate Body Report, Thailand – H-Beams , para. 88). 
131Ibid., para. 184.  
132Ibid., para. 188. 
133Ibid. (original emphasis) 
134Ibid., para. 195. 
135Ibid. 
136Ibid., para. 196. 
137Ibid., para. 203. 
138Ibid., para. 196. WT/DS321/AB/R 
Page 28  
 
circumstances, because this would amount to asking th em to review and criticise reports that are their 
own doing".
139  
66. In addition, the European Communities claims th at the Panel's decision to select these experts 
was "based on a very narrow definition of a perceive d conflict of interest because it required an actual 
or almost certain conflict, not a perceived, likelihood or a justifiable doubts test".140  According to the 
European Communities, a perceived conflict of interest  arises in this dispute due to the fact that 
Dr. Boisseau took "a position in favour of the safety of these hormones" and Dr. Boobis "has been 
receiving funding from the pharmaceutical industry in his research and counselling".141   
67. The European Communities alleges several further errors committed by the Panel.  It faults 
the Panel for "relying overwhelmingly"142 on the opinions of Drs. Boisseau and Boobis on practically 
all scientific aspects of the matters;  for failing to ensure that Drs. Boisseau and Boobis complied with 
the self-disclosure requirement before their selection;   and for failing to " actually examine[] whether 
all of the experts had a potential conflict of interest  and whether [Drs. Boisse au and Boobis] fulfilled 
the conditions to be truly independent and impartial".143  Finally, the European Communities argues 
that, "even if one were to take the view that  the Panel[] could accept the non-independent experts 
provided that they would constantly bear in mind th e potential conflicts [of interest and the lack of 
independence] when weighing the expert opinions, it is clear that the Panel[] refused to do so, considering the issue of the experts finally reso lved when dismissing the European Communities' 
objections."
144  Indeed, these experts "dominate[d] the en tire scientific examination by the Panel[] 
both from the point of view of how often they [w ere] referred to and whether the Panel[] ever 
question[ed] their opinions and whether their opinion s go beyond science and stray into the area of the 
risk regulator."145 
68. On this basis, the European Co mmunities submits that the Panel fa iled to respect the principle 
of due process;  failed to ensure compliance w ith the requirements on self-disclosure under the  Rules 
of Conduct ;  erred in accepting as experts persons w hose independence and impartiality was not
                                                      
139European Communities' appellant's submission, para. 205.  The European Communities seeks to 
draw analogy from a judgment by the European Court of Human Rights, which found that a person was denied a 
fair trial because the expert appointed by the relevant tr ibunal had drafted the report triggering the trial against 
that person. ( Ibid., para. 206 (referring to European Court of Human Rights, Judgment of 6 May 1985, Case of 
Bönisch v. Austria , Application no. 8658/79 (Exhibit EC-131 submitted by the European Communities to the 
Appellate Body))) 
140European Communities' appellant's submission, para. 203. 
141Ibid. 
142Ibid., para. 212. 
143Ibid., para. 192. 
144Ibid., para. 211. (footnote omitted) 
145Ibid., para. 208.  WT/DS321/AB/R 
 Page 29 
 
 
assured;  and acted inconsistently with its obliga tions under Article 11 of the DSU.  The European 
Communities therefore requests the Appellate Body to "reverse all the findings of the Panel[] which 
depend on the advice they received from" Drs. Boisseau and Boobis.146 
7. Article 5.1 of the  SPS Agreement  
69. The European Communities argues that the Panel erred in finding that the permanent ban on 
meat and meat products from cattle treated with oestradiol-17 β applied pursuant to 
Directive 2003/74/EC was not based on a risk assess ment within the meaning of Article 5.1 and 
Annex A, paragraph 4, of the  SPS Agreement .  The European Communities requests the Appellate 
Body to reverse this finding for the following reasons. 
70. The European Communities submits that the Pane l erred in its interpre tation and application 
of Article 5.1 and Annex A,  paragraph 4, of the  SPS Agreement  as informed by Article 5.2 of that 
Agreement.  The European Communities asserts th at the Panel "[a]dopted an extremely narrow and 
consequently erroneous"147 interpretation of "risk assessment" wh en it excluded from the scope of its 
analysis under Article 5.1 arguments and evidence concerning the misuse and abuse and difficulties of 
control in the administration of hormones to ca ttle for growth-promotion purposes.  The European 
Communities refers to the Panel's statement that Article 5.2 of the  SPS Agreement  "instructs 
Members on how to conduct a risk assessment"148, and argues that the Panel erroneously rendered 
Article 5.2 "entirely procedural ".149  In the European Communities' view, Article 5.2 "does not 
prescribe a given method or procedure to be follo wed in conducting a risk assessment", but provides 
"substantive factors "150 to be taken into account in a risk  assessment and offe rs guidance on the 
substantive content of a "risk assess ment" within the meaning of Article  5.1.  Consequently, the Panel 
made a "fundamental legal error" by "considerably narrowing down the scope"151 of a risk assessment 
within the meaning of Article 5.1.  In doing so, the Panel wrongly excluded "risk management" 
aspects from the coverage of Article 5.1, and thereb y adopted the same restrictive interpretation of 
"risk assessment" in Article 5.1 that w as overturned by the Appellate Body in EC – Hormones .152 
71. The European Communities relies on the Appellate Body's finding in EC – Hormones  that 
risk assessors "may examine and ev aluate ... risks arising from potential abuse in the administration of 
                                                      
146European Communities' appellant's submission, para. 212. 
147Ibid., para. 308. 
148Ibid., para. 316 (quoting Panel Report, US – Continued Suspension , para. 7.440). (emphasis omitted) 
149Ibid., para. 320. (original emphasis) 
150Ibid., para. 316. (original emphasis) 
151Ibid., para. 320.  
152Ibid., para. 322 (referring to Appellate Body Report, EC – Hormones , para. 187).  WT/DS321/AB/R 
Page 30  
 
controlled substances and from control problems".
153  The European Commun ities maintains that the 
SCVPH Opinions explicitly addressed evidence concer ning the abusive use and difficulties of control 
in the administration of hormones for growth -promotion purposes, and yet the Panel "simply 
ignore[d] the evidence".154  The Panel failed to take account of the fact that the abusive use and 
difficulties of control were important factors in the risk assessment underlying the SCVPH Opinions, 
adding considerably to the risk identified.  Inst ead, the Panel instructed the scientific experts to 
examine only that part of the evidence concer ning the residues in meat from these hormones 
administrated "in accordance with good veterinary practice".155  The European Communities adds that 
the fact that Codex Alimentarius Commission ("Codex") standards do not usually address the 
possibility of misuse and abuse throws the Panel's a pproach into question, because the notion of risk 
assessment under Article 5.1 of the  SPS Agreement  is clearly wider than that under Codex.   
72. The European Communities also asserts that th e Panel erred in finding that the European 
Communities has acted inconsistently with Article 5.1 by failing to evaluate specifically the risks 
arising from residues of oestradiol-17 β in meat from cattle treated with this substance for growth-
promoting purposes.  The European Communities hi ghlights the conclusion in  the risk assessment 
underlying Directive 2003/74/EC that new evidence concerning the genotoxicity156 of oestradiol 
suggests that oestradiol-17 β "acts as a complete carcinogen by exerting tumour initiating and 
promoting effects".157  This conclusion demonstrates that the risk assessment focused on and 
addressed specifically the particular kind of risk s at stake—the carcinogenic and genotoxic potential 
of the residues of oestradiol-17 β found in meat treated with this hormone.   
73. The European Communities maintains furthe r that the Panel erred in requiring the 
quantification of the risks to human health arisi ng from the consumption of meat containing residues 
of oestradiol-17 β.  The European Communities asserts that , by referring to "potential occurrence"158 
of adverse effects when posing questions to the ex perts, the Panel "imposed a quantitative method of 
                                                      
153European Communities' appellant's submission, para. 324 (referring to Appellate Body Report, EC – 
Hormones , paras. 206 and 207). 
154Ibid., para. 329. 
155Ibid., para. 274 (referring to Question 13 posed by the Panel to the scientific experts, Panel Reports, 
Annex D, p. D-22;  Panel Report, US – Continued Suspension , paras. 6.102, 6.164, and 6.165;  and Panel 
Report, Canada – Continued Suspension , paras. 6.94, 6.154, and 6.155). 
156Genotoxicity is the ability to cause damage to genetic material (DNA).  Such damage may be 
mutagenic and/or carcinogenic.  (See Panel Report, US – Continued Suspension , footnote 370 to para. 7.77;  and 
Panel Report, Canada – Continued Suspension , footnote 362 to para. 7.75 (referring to replies of Dr. Boobis and 
Dr. Guttenplan to Question 2 posed by the Panel to the scientific experts, Panel Reports, Annex D, paras. 41 
and 58, respectively)  See also tr anscript of the Panel's joint meeting with the scientific experts 
on 27-28 September 2006, Panel Reports, Annex G, paras. 85-90) 
157European Communities' appellant's submission, para. 337 (referring to 1999 Opinion, p. 73).  
158Ibid., para. 346.   WT/DS321/AB/R 
 Page 31 
 
 
risk assessment on the European Communities bo rrowed from Codex Alimentarius and JECFA".159  
However, the Panel's rejection of a "purely qualitative analysis of risk"160 and the imposition of such a 
quantitative requirement find no basis in the  SPS Agreement  and contradict the Appellate Body's 
finding in EC – Hormones  that a risk assessment under the  SPS Agreement  does not require the 
establishment of a minimum magnitude of risk.  In addition, the experts acknowledged that 
quantification of risk is not necessary for subs tances that have genotoxic potential, such as 
oestradiol-17 β.  For this reason, the European Communities suggests that a qualitative analysis of risk 
must be  a fortiori  sufficient to meet the requirements of Article  5.1 and Annex A, paragraph 4, of the  
SPS Agreement .  
74. The European Communities argues that the Pane l erred in allocating the burden of proof 
under Article 5.1 of the  SPS Agreement .  The fact that the European  Communities is the complaining 
party in this dispute "does not change the basic standard on the burden of proof under the  SPS 
Agreement ".161  Accordingly, it was incumbent upon the United States and Canada to rebut the  prima 
facie  case of consistency made by the European Co mmunities in relation to Directive 2003/74/EC.  
The European Communities submits th at, because of the particularity of the case, this obligation to 
rebut the  prima facie  case made by the European Commun ities amounts to the same standard as 
making a  prima facie  case in a dispute where the United States and Canada proceed with a normal 
panel procedure against an SPS measure taken by th e European Communities.  The Panel nevertheless 
found that the United States and Canada had "su fficiently refuted the [European Communities'] 
allegation of compliance in [their] first written submission[s] through positive evidence of breach of 
the  SPS Agreement "162 without articulating the rationale for this conclusion.  Therefore, the Panel 
erred in law in shifting the burden of proof to the European Communities without first examining, 
provision by provision under the  SPS Agreement , whether the arguments of the United States and 
Canada had sufficient merit to shift the burden  of proof back to the European Communities. 
75. The European Communities furt her argues that the Panel failed to conduct an objective 
assessment of the facts of the case, as required by  Article 11 of the DSU.  While the European 
Communities agrees with the Appellate Body's interp retation of the standard of review applicable 
under the  SPS Agreement , it also notes that, when reviewing governmental measures in highly 
complex or technical matters, domestic courts and international tribuna ls usually follow a 
"reasonableness" approach to the fact-finding of competent authorities.  The European Communities 
                                                      
159European Communities' appellant's submission, para. 308.  See also ibid., para. 296. 
160Ibid., para. 353 (referring to Panel Report, US – Continued Suspension , para. 7.530;  and Panel 
Report, Canada – Continued Suspension , para. 7.502). 
161Ibid., para. 287. 
162Ibid., para. 288 (quoting Panel Report, US – Continued Suspension , para. 7.385;  and Panel Report, 
Canada – Continued Suspension , para. 7.382).  WT/DS321/AB/R 
Page 32  
 
recalls that, according to the Appellate Body's in terpretation of Article 5.1, Members are entitled to 
rely on "divergent opinion[s] coming  from qualified and respected sources"
163 in their risk 
assessments when adopting SPS measures.  For this  reason, a panel reviewing a Member's SPS 
measure under Article 5.1 should seek to determine whether there is any reasonable scientific basis 
for such measures and respect the "important and autonomous right"164 of Members to set their level 
of SPS protection.  A panel should not substitute its  scientific judgement for that of the Member 
taking the measure and should not "second guess"165 Members, particularly in situations where 
available science is providing alternative and competing explanations.  Thus, in this dispute, the Panel 
should have asked whether there were divergent opi nions in the scientific community, and, if the 
European Communities based itself on a divergen t opinion, if those opinions are qualified and 
respected. 
76. Instead of determining "whether there was any reputable support within the relevant scientific 
community for the determination made by the Europ ean Communities in the light of its chosen level 
of protection"166, the Panel stated that it was in a situation "similar"167 to that of a risk assessor and 
sought to determine what the correct scientific conclu sions were relating to the hormones at issue.  In 
doing so, the Panel "drifted into a  de novo  review"168 of the European Comm unities' risk assessment 
and decided "to become the jury on the correct  science ... by picking and choosing between the 
conflicting and contradictory opinions of the experts in an arbitrary manner".169  The Panel imposed 
its choices on the European Communities between the different "scientifically plausible alternatives", 
either by basing itself on the views expressed by a ma jority of the experts, or by selecting the "most 
specific" or "best supported" views.170  As a result, the Panel failed to take into account diverging 
views reflecting a "genuine and le gitimate scientific controversy"171 among the experts over the safety 
of residues of hormones in meat.  The Panel also ig nored that some of the experts reported the same 
concerns as expressed in the SCVPH Opinions, "praised"172 the analysis in those Opinions, or 
highlighted that the Opinions followed a different, but equally plausible, scientific approach. 
77. The European Communities alleges the following sp ecific errors in connection with its claim
                                                      
163European Communities' appellant's submission, para. 226 (quoting Appellate Body Report, EC – 
Hormones , para. 194). (emphasis omitted) 
164Ibid., para. 222 (referring to Appellate Body Report, EC – Hormones , para. 172). (emphasis omitted) 
165Ibid., para. 222. 
166Ibid., para. 240. 
167Ibid., para. 237 (quoting Panel Report, US – Continued Suspension , para. 7.418;  and Panel Report, 
Canada – Continued Suspension , para. 7.409). 
168Ibid., para. 237. 
169Ibid., para. 239. (emphasis omitted) 
170Ibid., para. 240. 
171Ibid., para. 248.  
172Ibid., para. 247.  WT/DS321/AB/R 
 Page 33 
 
 
that the Panel failed to make an objective assessment of the facts.  First, the European Communities 
alleges that the Panel acted inconsistently with Article 11 of the DSU when it failed to take into 
account evidence related to the asse ssment of risks to human health  arising from exposure to residues 
of hormones from multiple endogenous and exog enous sources.  The European Communities 
maintains that the Panel Reports explain this issue "very briefly"173, even though it was raised several 
times in the European Communities' written submissions and comments, and was discussed 
extensively during the meeting of the Panel with the experts.  The European Communities observes 
that "there is no mention at all [of the risks of multiple exposures] in the Panel['s] findings."174 
78. Secondly, the European Communities maintains that the Panel "failed to consider or 
distorted"175 scientific evidence demonstrating that no safe threshold levels exist for the consumption 
by humans of oestradiol-17 β due to its actual or potential genot oxicity.  The European Communities 
emphasizes that a majority of the experts advising th e Panel agreed that there was sufficient scientific 
evidence in support of the European Comm unities' conclusion that oestradiol-17 β is actually or 
potentially genotoxic.  However, the Panel "side-stepped" such crucial evidence and 
"mischaracteri[zed]" the evidence when finding th at the European Communities had "not provided 
analysis of the potential for these [genotoxic] effect s to arise from the consumption of meat and meat 
products which contain residues of oestradiol-17 β".176  The European Communities observes that to 
have conclusive evidence on whether or not a thre shold can be applied "mi ght require scientific 
testing on humans", which would be "totally  unethical" and require a Member "to do the 
impossible".177  The European Communities considers the c onclusion that no threshold levels may be 
established in relation to oestradiol-17 β to be "just as valid"178 scientifically as the opposing position 
held by the United States, Canada, and JECFA.  Therefore, the Panel acted inconsistently with 
Article 11 of the DSU by ignoring "the totality of the evidence"179 and by failing to recognize the 
significance of the "'genuine' and 'legitimate' scientific controversy"180 relating to the question of 
whether risks to human health arising from th e consumption of residues of oestradiol-17 β could be 
addressed through the establishment of threshold levels.  
                                                      
173European Communities' appellant's submission, para. 249 (referring to Panel Report, US – Continued 
Suspension , paras. 7.502 and 7.503;  and Panel Report, Canada – Continued Suspension , paras. 7.474 
and 7.475).  
174Ibid., para. 249.  
175Ibid., para. 250.  
176Ibid., para. 251 (quoting Panel Report, US – Continued Suspension , para. 7.537;  and Panel Report, 
Canada – Continued Suspension , para. 7.509).   
177Ibid., para. 258. 
178Ibid. 
179Ibid. 
180Ibid. WT/DS321/AB/R 
Page 34  
 
79. The European Communities argues furthermore that the Panel reached the "manifestly 
unfounded"
181 finding that the European Communities had not evaluated the specific risks to humans 
arising from the consumption of meat containing residues of oestradiol-17 β as a result of the cattle 
being treated with this hormone for growth-promo tion purposes.  In reaching this finding, the Panel 
incorrectly imposed a "specifi city" or "direct causality"182 requirement pursuant to which the 
European Communities had to demonstrate  actual  adverse effects, rather than the  possibility  of 
adverse effects, contrary to the Appellate Body's findings in EC – Hormones  and Japan – Apples .183  
In the European Communities' view, the Appellate Body's findings in these disputes did not prevent a 
Member from meeting the standard in Article 5.1 by  demonstrating that the identified adverse effects 
may " possibl[y] arise  from the residues in meat" and that "there is no need to demonstrate real 
causality" as the Panel in this dispute required.184  Moreover, the European  Communities notes that no 
country has conducted the kind of specificity t est required by the Panel, and the European 
Communities cannot be found in violation of the  SPS Agreement  for failing to meet such a test.  In 
addition, the Panel ignored the fact that three of  the experts advising the Panel confirmed that the 
potential for adverse effects had been demonstrated by  the European Communities.  On this basis, the 
European Communities submits that the Panel ignor ed and "grossly misinterpreted" part of the 
relevant evidence in reaching this finding and failed to explain how its conclusions "have a reasonable 
relationship to the totality of the evidence".185  As a result, the Panel exceeded the bounds of its 
discretion as the trier of facts in its assessment of the evidence, in violation of Article 11 of the DSU.  
80. The European Communities submits that the Pa nel failed to interpret and apply correctly 
Article 5.1 of the  SPS Agreement  and failed to conduct an objective assessment of the matter as 
required by Article 11 of the DSU.  Therefore, the European Communities requests the Appellate Body to reverse the Panel's findings under Article 5.1 of the  SPS Agreement . 
8. Article 5.7 of the  SPS Agreement
 
81. The European Communities argues that the Panel erred in finding that the relevant scientific 
evidence on the five hormones was not "insufficien t" within the meaning of Article 5.7 of the  
SPS Agreement  and that, consequently, the provisional ba n on the importation and marketing of meat 
                                                      
181European Communities' appellant's submission, para. 270.  
182Ibid., para. 262. 
183Ibid., para. 261 (referring to Panel Report, US – Continued Suspension , paras. 7.511 and 7.512;  and 
Panel Report, Canada – Continued Suspension , paras. 7.483 and 7.484, in turn referring to Appellate Body 
Report, EC – Hormones , para. 200;  and Appellate Body Report, Japan – Apples , para. 202 and footnote 372 
thereto). 
184Ibid., para. 261. (original emphasis) 
185Ibid., para. 270.   WT/DS321/AB/R 
 Page 35 
 
 
from cattle treated with these five hormones do es not meet the requirements of Article 5.7 .  T h e  
European Communities requests the Appellate Body to reverse this finding for the following reasons. 
82. First, the European Communities ar gues that the Panel erred in its  interpretation of Article 5.7 
because it expressly rejected the relevance of the le vel of protection set by a Member for evaluating 
whether the scientific evidence is "i nsufficient" within the meaning of Article 5.7.  The European 
Communities takes issue with the Panel's "sweeping statement"186 that the "presumption of 
consistency of measures conforming to international standards", provided in Article 3.2 of the  SPS 
Agreement , "implies that these standards ..., particularly those referred to in this case, are based on 
risk assessments that meet the requirements of the  SPS Agreement ."187  According to the European 
Communities, the presumption of consistency that applies to measures conforming to international 
standards under Article 3.2 does not necessarily lead to the conclusion that the scientific evidence 
underlying the international standards is sufficient to conduct a risk assessment within the meaning of 
Article 5.1.  This is because the international sta ndard may not be based on a risk assessment at all, 
may be based on a risk assessment that is not informed  by all factors listed in Articles 5.1 and 5.2, or 
the relevant evidence behind the international standard  may be insufficient, or outdated, or no longer 
the mainstream scientific opinion. 
83. The European Communities asserts that an in ternational standard already "implies or 
encapsulates"188 a certain level of protection.  However, Article 3.3 of the  SPS Agreement  allows 
Members to adopt SPS measures that result in a highe r level of protection than the one underlying an 
international standard.  Consequently, the inte nded level of protection must be relevant for 
determining whether the scientific evidence is "insuf ficient" within the meaning of Article 5.7, and a 
Member that sets a higher level of protection may find the relevant scientific evidence underlying an international standard to be insufficient.  The Eu ropean Communities thus maintains that the Panel's 
approach entirely disconnected the sufficiency of the scientific evidence from the level of protection 
set by the European Communities, and this approach is  contrary to the explicit wording of Article 3.3 
and the views expressed by the experts it had select ed.  Referring to the distinction drawn by the 
Appellate Body in Japan – Apples  between "scientific uncertainty" and "insufficiency of scientific 
evidence"
189, the European Communities notes that this  distinction does not exclude that the 
insufficiency of the scientific evidence may be due to  scientific uncertainty creat ed by the existence of 
divergent minority opinions. 
                                                      
186European Communities' appellant's submission, para. 388.  
187Ibid., para. 387 (quoting Panel Report, US – Continued Suspension , para. 7.644;  and Panel Report, 
Canada – Continued Suspension , para. 7.622).  
188Ibid., para. 397.  
189Ibid., paras. 377 and 378 (referring to Appellate Body Report, Japan – Apples , para. 184). WT/DS321/AB/R 
Page 36  
 
84. Secondly, the European Communities argues that the Panel erred in imposing on the 
European Communities the initial burden of dem onstrating that Directive 2003/74/EC meets the 
requirements of Article 5.7 in relation to the prov isional ban on the five hormones at issue.  By 
imposing the burden of proof on the European Communities, the Panel "seem[ed]"
190 to have 
erroneously considered Article 5.7 as an exception to the rules laid down in Article 5.1, even though 
Article 5.7 confers to WTO Members a "qualified right"191 to take provisional measures under certain 
conditions.  The European Communiti es maintains that Article 5.7 has "its own legal regime that is 
distinct from Article 5.1".192  This is because Article 2.2 of the  SPS Agreement  explicitly exempts 
measures taken under Article 5.7 from its scope of application, and Ar ticle 5.1, which is a specific 
application of the obligations in Article 2.2, cannot be applicable under the circumstances where 
Article 2.2 is not applicable.  The European Communities recalls the Appellate Body's finding in 
Japan – Apples  that a link exists between Articles 5.7 and 5.1 in that "relevant scientific evidence" 
will be "insufficient" within the meaning of Article  5.7 if the body of available scientific evidence 
does not allow the performance of an adequate assessment of risks as required under Article 5.1.193  
On this basis, the European Comm unities argues that "there is a continuum of 'relevant scientific 
evidence' that is divided between the respective scopes of application of Articles 5.1 and 5.7."194  
Therefore, a Member that is "su fficiently diligent ... must be able"195 to take an SPS measure under 
either Article 5.1 or Article 5.7, and the sufficien cy of the scientific evidence "is determinative on 
whether or not the measure concerne d falls under Article 5.1 or 5.7".196  Thus, the European 
Communities argues that, because it has a right to im pose provisional measures when it considers that 
relevant scientific evidence is insufficient, the Un ited States and Canada should bear the burden of 
demonstrating that this condition for applying pr ovisional measures under Article 5.7 has not been 
fulfilled.  Instead, the Panel erroneously shifted this burden to the European Communities when it 
limited its review exclusively to the "insufficiencies"197 identified by the European Communities in its 
submissions.  By requiring the European Commun ities to identify the issue for which relevant 
scientific evidence is insufficient, the Panel allo cated to the European Co mmunities the burden "to 
prove the negative".198 
                                                      
190European Communities' appellant's submission, para. 362.   
191Ibid., para. 368.   
192Ibid., para. 367.  
193Ibid., para. 371 (quoting Appellate Body Report, Japan – Apples , para. 179). 
194Ibid., para. 374.  
195European Communities' statement at the oral hearing. 
196European Communities' appellant's submission, para. 374.  
197Ibid., para. 380 (quoting Panel Report, US – Continued Suspension , para. 7.653;  and Panel Report, 
Canada – Continued Suspension , para. 7.630).  
198Ibid., para. 291.  WT/DS321/AB/R 
 Page 37 
 
 
85. Thirdly, the European Communities argues th at the Panel erred in finding that, where 
international standards for a substance exist, a "critic al mass" of new scientific evidence that calls into 
question the fundamental precepts of previous knowle dge is required to render the relevant scientific 
evidence "insufficient" within the meaning of Article  5.7.  The European Communities asserts that the 
"critical mass" standard developed by the Pa nel "imposed a high quantitative and qualitative 
threshold"199 with respect to the new scien tific evidence that is required to render prior scientific 
evidence insufficient.  The Europ ean Communities submits that the quality of the scientific evidence 
is more important that the quantity.  For this reason, even a single study made by qualified and 
respectable scientists, even when in the minority, could be considered  a priori  sufficient to question 
the sufficiency of the previous sci entific evidence if its merits are particularly relevant for the 
circumstances of the risk assessment.  According to the European Communiti es, the Panel's mistake 
stemmed from the erroneous premise of its analysis that the existence of an international standard 
presupposes that the scientific eviden ce has been sufficient to conduc t a risk assessment.  This error 
led the Panel to assume wrongly that a "critical ma ss" of new evidence is required to question the 
sufficiency of the scientific evidence and con sequently to disregard "serious concerns"200 expressed 
by the experts in relation to the "fundamental scientific controversy"201 concerning the risks to human 
health posed by the five hormones.   The European Communities observ es that the relevant question is 
not only whether relevant scientific evidence can "become" insufficient, but also whether it "is" 
insufficient in the first place.202  Furthermore, the European Co mmunities argues that the Panel's 
application of the "critical mass" standard excludes  a priori   the possibility of a WTO Member basing 
its risk assessment on a "respectable minority view".203  This effectively "preclude[d] [the] 
application"204 of the precautionary principle in the interpre tation of Articles 5.1 and 5.7, contrary to 
the Appellate Body's finding that "the precautionary principle indeed finds reflection in Article 5.7 of the  SPS Agreement ."
205  The European Communities explains that  the Panel's "critical mass" standard 
implies that the scientific eviden ce passes immediately from a state of insufficiency to a state of 
complete knowledge, because ther e will be no "transitional period"206 in which Article 5.7 could 
apply.   
86. The European Communities alleges that, in a pplying the "critical mass" standard to the 
evidence before it, the Panel "systematically downplay[ed]"207 and ignored "highly relevant scientific 
                                                      
199European Communities' appellant's submission, para. 412.  
200Ibid., para. 421.  
201Ibid., para. 426.  
202Ibid., para. 419. 
203Ibid., para. 409. 
204Ibid., para. 427. 
205Appellate Body Report, EC – Hormones , para. 124. 
206European Communities' statement at the oral hearing.  
207European Communities' appellant's submission, para. 427.  WT/DS321/AB/R 
Page 38  
 
evidence"
208 which "support[ed] the position of the European Communities ... that in fact the scientific 
evidence was indeed insufficient"209 to perform a risk assessment.   The European Communities 
challenges the Panel's analysis of the evidence on the following issues with respect to all five 
hormones:  (i) effects of hormones on certain populati on groups;  (ii) dose response;  (iii) long latency 
periods for cancer and confounding factors;  a nd (iv) adverse effects on human growth and 
reproduction.210  In addition, the European Communities raises specific concerns relating to the 
Panel's application of the "critical mass" standard when it evaluated the sufficiency of the information 
individually for each of the five hormones. 
87. As regards the Panel's finding that the scientific  evidence on the effects of the five hormones 
on certain population groups was not "insufficient" within the meaning of Article 5.7, the European 
Communities argues that the Panel ignored Dr. Sippe ll's testimony that the development of more 
sensitive detection methods has identified lower e ndogenous hormonal levels in  pre-pubertal children 
than previously thought, calling into question the range of physiological levels of sex hormones 
believed to exist in humans.  According to th e European Communities, the Panel downplayed the 
significance of this development by referring to Dr. Boobis' statement that such new detection 
methods were "not yet validated".211  In the area of dose response, the European Communities submits 
that the Panel Reports contain "no serious analysis"212 of this issue, and that the only basis articulated 
by the Panel in support of its conclusion was its prior finding that the ultra-sensitive detection 
methods had not yet been validated.  The European  Communities also suggests that the Panel ignored 
Dr. Cogliano's testimony confirming that the relevant scientific evidence was insufficient to conduct a 
risk assessment for all of the five hormones, b ecause "you cannot estimate that dose-response curve 
with any kind of certainty."213 
88. In respect of the long latency period of cancer and the existence of confounding factors, the 
European Communities argues that the Panel's "cri tical mass" standard "essentially require[d] the 
European Communities to do the impossible"214, because long latency periods for cancer and the 
existence of confounding factors do not permit th e establishment of a causal link between the
                                                      
208European Communities' appellant's submission, para. 447.  
209Ibid., para. 427.  
210In its appellant's submission, the European Comm unities also refers to the Panel's analysis 
concerning bioavailability. (European Communities' appellant's submission, paras. 179 and 432)  However, at 
the oral hearing, the European Communities stated that this issue was not implicated in its appeal of the Panel's 
findings under Article 5.7. 
211European Communities' appellant's submission, para. 430 (quoting Panel Report, US – Continued 
Suspension , para. 7.670;  and Panel Report, Canada – Continued Suspension , para. 7.647).   
212Ibid., para. 431.  
213Ibid., para. 444 (quoting transcript of the Panel' s joint meeting with the scientific experts 
on 27-28 September 2006, Panel Reports, Annex G, para. 871).   
214Ibid., para. 433.   WT/DS321/AB/R 
 Page 39 
 
 
prevalence of cancer and the consumption of residues of the five hormones in meat.  In order to 
establish such causal link, it would be necessary to  conduct tests on humans by isolating them from 
the rest of the population "for years if not d ecades", which constitutes "an unrealistic requirement".215  
89. As for the evidence of adverse effects of the five hormones on human growth and 
reproduction, the European Communities argues th at the Panel "systematically downplay[ed]"216 the 
opinions of Drs. Sippell and Guttenplan in reaching its  finding that the relevant scientific evidence 
was not "insufficient" within the meaning of Article  5.7.  For the European Communities, "[t]he fact 
that the new evidence relates inter alia  to children, the most vulnerable and sensitive part of the 
population, is a major concern for the European Comm unities" and this concern is "reinforced by the 
opinions expressed by Dr. Sippell and Dr. Guttenplan".217  The European Communities additionally 
maintains that the Panel "arbitrarily"218 gave a different status to the statements of different experts 
advising the Panel.  For example, whereas Dr. Gutte nplan's expression of con cerns regarding potential 
developmental effects of hormones on children was characterized by the Panel as an expression of "doubts"
219, the opinion of Dr. Boobis that new eviden ce obtained by the European Communities did 
not indicate additional concern regarding risks of th e five hormones was "manifestly given the status 
of scientific evidence".220   
90. Turning to the Panel's assessment of each of the five hormones indivi dually, the European 
Communities argues that the Panel ignored evidence de monstrating that progesterone and testosterone 
are carcinogenic to humans.  Such evidence consiste d of International Agency for Research on Cancer 
("IARC") studies that concluded that progesterone is "possibly carcinogenic to humans"221 and that 
testosterone is a "probable carcinogenic to humans".222  The European Communities further submits 
that the Panel confused Articles 5.1 and 5.7 when  it concluded that the IARC studies addressed the 
carcinogenicity of progesterone and testosterone in  general, but did not specifically address the 
carcinogenic potential to humans of consuming residu es of these hormones in meat.  According to the 
European Communities, it is preci sely because scientific evidence is lacking on this specific question 
that the European Communities decided to impose pr ovisional restrictions on the basis of available 
pertinent information.   
                                                      
215European Communities' appellant's submission, para. 434.  
216Ibid., para. 435.  
217Ibid., para. 436.  
218Ibid. 
219Ibid. (quoting Panel Report, US – Continued Suspension , para. 7.719;  and Panel Report, Canada – 
Continued Suspension , para. 7.696). 
220Ibid., para. 436.  
221Ibid., para. 437 (referring to Panel Report, US – Continued Suspension , para. 7.737;  and Panel 
Report, Canada – Continued Suspension , para.  7.714, in turn referring to IARC written replies to Question 25 
posed by the Panel, Panel Reports, Annex E-3, p. 129). (emphasis omitted) 
222Ibid., para. 438.   WT/DS321/AB/R 
Page 40  
 
91. With respect to the Panel's finding that the relevant scientific evidence on trenbolone acetate 
was not "insufficient" within the meaning of Artic le 5.7, the European Co mmunities argues that the 
Panel drew its conclusions exclusively on the basis of Dr. Boobis' opinion.  The European 
Communities draws attention to Dr. Guttenplan's opi nion that the scientific evidence showed that 
trenbolone acetate was "significantly estrogenic" a nd that it did not appear that "accurate ADIs 
[(acceptable daily intakes)] can be estab lished at this point" for this substance.
223  T h e  P a n e l  
"attempt[ed] to downplay"224 this opinion of Dr. Guttenplan by referring to his statement that, 
although accurate acceptable daily intakes ("ADIs") cannot  be established, a risk assessment can still 
be carried out.  In the European Communities'  view, the Panel failed to ascertain whether Dr. 
Guttenplan merely meant that the four steps of th e JECFA risk assessment can be formally conducted 
or whether a risk assessment within the meaning of Article 5.1 of the  SPS Agreement  can be 
conducted, and that it was the latter that was relevant to the Panel's analysis. 
92. As regards the Panel's finding that the relevant  scientific evidence was not "insufficient" in 
relation to the carcinogenicity of zeranol, the Eur opean Communities argues that the Panel failed to 
take into account Dr. Guttenplan's testimony that "additional tests of zeranol should be carried out".225  
The European Communities argues further that the Panel downplayed Dr. Sippell's concerns 
regarding the effects of zeranol in human breast  cancer cells by relying, instead, on Dr. Boobis' 
opinion.   
93. Moreover, the European Communities argues th at the Panel concluded "in a sweeping 
manner"226 that the evidence on MGA was "sufficient" to conduct a risk assessment, because a 
process towards adopting an international standard for this hormone is underway in Codex.  The 
European Communities also charges the Panel with downplaying the new studies the European 
Communities has conducted since 1999, even though the Panel recognized that the evaluation carried 
out by JECFA was based on studies that date back  to the 1960s and 1970s.  Furthermore,  the 
European Communities criticizes the Panel for disr egarding the opinion of Dr. De Brabander in 
relation to trenbolone acetate, zeranol, and MGA, wh ich called into question residue levels estimated 
by JECFA and raised concerns regarding the poten tial effects of these hormones and their metabolites 
on the environment.   
94. Finally, the European Communities asserts th at the Panel failed to make an objective
                                                      
223European Communities' appellant's submission, para. 439 (quoting Panel Report, US – Continued 
Suspension , para. 7.779;  and Panel Report, Canada – Continued Suspension , para. 7.761).  
224Ibid., para. 440. 
225Ibid., para. 441 (quoting Panel Report, US – Continued Suspension , para. 7.797;  and Panel Report, 
Canada – Continued Suspension , para. 7.781).  
226Ibid., para. 442.   WT/DS321/AB/R 
 Page 41 
 
 
assessment of the facts in reaching its findings under Article 5.7 of the  SPS Agreement , in violation 
of Article 11 of the DSU.  The European Commun ities underscores Dr. Cogliano' s statement that "the 
data are not sufficient" to conduct a "low-dose predic tion of risk at levels you might find in hormone-
treated meat"227, and observes that this statement was not reflected in the Panel Reports.  The 
European Communities argues that the Panel decided to accept only those expert opinions that it 
considered "acceptable", and in so doing the Pane l "arbitrarily chose between different scientific 
opinions" instead of establishing whether the Euro pean Communities had "followed a scientifically 
plausible alternative" when adopting Directive 2003/ 74/EC and the Panel thus "failed to recognise the 
legal significance of a genuine scientific controversy".228  Consequently, the Panel found that the 
SCVPH Opinions "came to the wrong scientific conclusions"229, and thus conducted a  de novo  
review of the facts, contrary to the requirement s in Article 11 of the DSU to make an objective 
assessment of the facts, as reflected in th e European Communities' risk assessment.   
95. The European Communities submits that the Pa nel failed to interpret and apply correctly 
Article 5.7 of the  SPS Agreement  and failed to conduct an objective assessment of the matter as 
required by Article 11 of the DSU.  Therefore, the European Communities requests the Appellate 
Body to reverse the Panel's findings under Article 5.7 of the  SPS Agreement . 
B. Arguments of the United States – Appellee  
1. Procedural Issue – Public Observation of the Oral Hearing  
96. The United States requests that the Appellate Body allow public observation of the oral 
hearing in these proceedings.  The United States re fers to the experience with open hearings at the 
panel stage and states that this development has b een of great benefit to the WTO and the multilateral 
trading system.  The United States explains that "[t]he ability of the public at large—
e.g., representatives of civil society, such as NGOs , journalists, academics, and individual citizens—to 
observe dispute settlement hearings has helped foster greater confidence in the WTO dispute 
settlement system and the manner in which it operates."230  The United States also considers that the 
practice of having open panel meetings with the pa rties has served to strengthen the "legitimacy and 
credibility"231 of the system and that this increased conf idence in the dispute settlement process can 
translate into a greater acceptance of the outcome of the dispute settlement proceeding, with potential 
benefits in respect of implementation.  In addition, the United States points out that the practice of 
                                                      
227European Communities' appellant's submission, para. 279 (quoting transcript of the Panel's joint 
meeting with the scientific experts on 27-28 September 2006, Panel Reports, Annex G, para. 871).   
228Ibid., para. 281. 
229Ibid., para. 282. 
230United States' request for an open hearing, para. 5. 
231Ibid. WT/DS321/AB/R 
Page 42  
 
opening panel meetings with the parties has also be en of great benefit to the governments of many 
WTO Members because "a significant number of dele gates from WTO Members that were not parties 
to the dispute have taken advantage of the opportun ity to attend an open panel meeting in order to 
follow a dispute more closely than they otherwise could."
232  The United States further notes that 
"opening meetings allows the WTO to compare more favourably to other international fora"233 and 
refers to the practice of many international tri bunals.  The United States observes that this dispute 
involves questions of human health and scientific judgements and therefore "provides a particularly 
strong example of public interest in WTO dispute settlement".234   
97. In the United States' view, there is nothing in the DSU, the  Working Procedures  or the Rules 
of Conduct  that addresses the issue of open hearings "directly".235  The United States does not 
consider that Article 17.10 precludes open appellate  hearings.  The United States argues that because 
there is no mention of an Appellate Body oral hearing in the DSU, "Article 17.10 cannot be directed 
at the question of whether such a hearing should be open or closed."236  The United States observes, in 
this regard, that third parties that were not third participants in both appeals in US – Shrimp (Thailand) 
and US –  Customs Bond Directive  were allowed to attend the consolidated oral hearing that was held 
for those appeals.  The United States adds that  "[s]omething similar appears to have occurred"237 in 
the US – 1916 Act  appellate proceedings.  The United States submits, furthermore, that "there is 
nothing in the DSU that authorizes a third party to observe any Appellate Body hearing" and that, "[i]f 
Article 17.10 required that the hearing be confid ential, then the Appellate Body could not have 
permitted third parties to observe the hearing."238 
98. According to the United States, Article 17.10 h as not been interpreted as "literally requiring 
the confidentiality of Appellate Body hearings" because Appellate Body re ports "routinely describe 
events at a hearing or even include quotations  from the statements or answers to questions".239  
Moreover, the United States notes that an Appellate Body report routinely discloses the arguments of 
the participants and third participants in their wr itten submissions, and Notices of Appeal and of Other 
Appeal are always circulated as public WT/DS documents. 
99. The United States also emphasizes that Article 17.10 must be read and applied in conjunction 
with Article 18.2 of the DSU.  For the United Stat es, the phrase "[n]othing in this Understanding" in 
                                                      
232United States' request for an open hearing, para. 6. 
233Ibid., para. 7. 
234Ibid., para. 13. 
235Ibid., para. 15. 
236Ibid., para. 17. 
237Ibid., para. 19. 
238Ibid., para. 20. 
239Ibid., para. 21.  WT/DS321/AB/R 
 Page 43 
 
 
Article 18.2 must be read to mean "that not even Article 17.10 could interfere with a party's right to 
disclose its own positions to the public, including stat ements made in the course of an Appellate Body 
hearing".240  The United States adds that if the statements and answers to questions can be made 
public by the participants, there is no reason why the parties cannot agree to have such statements and 
answers made public at the time they are uttered.   
100. The United States alleges that it is not aware of  anything in the negotiating history of the DSU 
that would suggest that parties could not agr ee to open an Appellate Body hearing to public 
observation.  Nor does the United States consider that the  Working Procedures  require an oral 
hearing that is closed to the public.  Fu rthermore, it does not see anything in the  Rules of Conduct  
that would be an impediment to opening the hear ing, because where parties agree to make their 
statements in the presence of the public, "there is no confidential information to be protected and no 
confidentiality of the proceedings to be maintained."241  The United States clarifies that by authorizing 
the request of the participants, the Appellate Body "would not be prejudging"242 the DSU review 
negotiations. 
101. In response to the comments of the third pa rticipants, the United States refers to the 
Recommendations by the Prepar atory Committee for the WTO.243  The United States asserts that the 
Recommendations indicate that the Preparatory Co mmittee viewed Article 17.10 as focused on the 
deliberations of the Appellate Body and any confid ential information submitted by the participants to 
an appeal.  The United States also argues that the third participants that oppose the request to open the 
hearing fail to reconcile their understanding of the term "proceedings" with the fact that statements 
made at the oral hearing and responses to questions  are routinely quoted and described in Appellate 
Body reports.  Moreover, the United States points out th at Article 18.2 refers to "statements of its own 
positions", which include responses to questions pos ed at the oral hearing, and does not impose a 
limitation on when the disclosure may occur.  Fina lly, the United States rejects the argument that the 
Appellate Body may not consider the request to open the hearing because transparency is being 
discussed in the DSU review negotiations. 
102. The United States therefore requests that the A ppellate Body allow public observation of the 
oral hearing and discusses several modalities that  could be used to accommodate any third 
participants wishing to maintain the confidentialit y of their submissions.  The United States, however, 
                                                      
240United States' request for an open hearing, para. 24. (emphasis omitted) 
241Ibid., para. 26. 
242Ibid., para. 28. 
243United States' comments on third participants' comme nts, paras. 5 and 6 (referring to Establishment 
of the Appellate Body:  Recommendations by the Preparatory Committee for the WTO approved by the Dispute 
Settlement Body on 10 February 1995 (WT/DSB/1), para. 9). WT/DS321/AB/R 
Page 44  
 
indicates a preference for allowing public observa tion by means of closed-circuit simultaneous 
broadcast. 
2. Articles 23.2(a) and 21.5 of the DSU
 
103. The United States submits that the Panel properly found that the phrase "recourse to dispute 
settlement" within the meaning of Article 23.2(a) of  the DSU is not limited to an Article 21.5 panel 
proceeding and that Article 23.2(a) did not require the United States to initiate a compliance panel proceeding for purposes of examining the comp atibility of Directive 2003/74/EC with the 
SPS Agreement . 
104. The United States considers that the Panel's in terpretation of the phrase "recourse to dispute 
settlement in accordance with [the  DSU]" in Article 23.2(a) as encompassing all procedures under the 
DSU, rather than relating exclusively to an Ar ticle 21.5 panel proceeding, was "sensible and well 
supported"
244 by the text of the DSU.  The United States observes that Article 21.5 refers to "these 
dispute settlement procedures" without specifying any particular subset of the procedures provided in 
the DSU, and thus does not exclude  any aspect of the DSU procedures.245  Moreover, in the United 
States' view, a complaining party always retains the option to initiate an ordinary panel proceeding to 
avoid the limitations on the scope of measures and claims that may be brought in an Article 21.5 
proceeding.  Therefore, the United States argues, Article 21.5 provides no contextual support for the 
European Communities' assertion that the phrase "rules and procedures of [the DSU]" in 
Article 23.2(a) refers exclusively to a panel operating under the jurisdictional limitations and 
accelerated timeframes provided for in Article 21.5.  The United States contends that, unless the European Communities is suggesting that it would refu se to participate in any proceeding other than a 
compliance panel proceeding initiated by the Un ited States to examine the consistency of 
Directive 2003/74/EC with the  SPS Agreement , there is no reason to assume that an Article 21.5 
proceeding is the only means by which the United States and the European Communities could reach 
a resolution of this dispute.   
105. The United States disagrees with the European Co mmunities' interpretation of the term "shall 
be decided" in Article 21.5 as indicating that "fin al" resolution results only from a panel proceeding.  
If that were the case, this dispute would have been finally resolved in 1998 with the adoption of the 
DSB's recommendations and rulings in EC – Hormones .  The United States argues that the term "shall 
be decided" should not be read in such a restrictiv e way, because the goal of the DSU is to secure a 
positive resolution, and a mutually acceptable soluti on is preferable for achieving this goal.  The 
                                                     
 
244United States' appellee's submission, para. 126. 
245See ibid., para. 127.  WT/DS321/AB/R 
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United States also disagrees with the European Communities' contention that the term "shall be 
decided" in Article 21.5 requires a decision by an adjudicative body.  Rather , the use of the passive 
tense leaves open the question by whom a disagre ement under Article 21.5 should be decided, and 
may include the parties, a regular panel, an arb itrator, or a mediator or other facilitator.   
106. The United States submits that the European  Communities' "frustrated experience as an 
original responding party"246 initiating an Article 21.5 proceeding in  EC – Bananas III (Article 21.5 –
EC) does not lead to the conclusion that such an a pproach is disallowed by the DSU.  The United 
States argues that the European Communities "cannot have it both ways":  insisting, in  EC – 
Bananas III (Article 21.5 – EC) , upon the right to initiate an Article 21.5 proceeding when it "thought 
that avenue would be to its adva ntage", and now arguing that an original respondent is foreclosed 
from initiating an Article 21.5 proceeding.247  Moreover, the United States rejects the European 
Communities' claim that the fact that the panel report in  EC – Bananas III (Article 21.5 – EC)  was 
not adopted signifies certain "subsequent practice"248, noting that it was the European Communities 
itself that did not seek adoption of that report.249 
107. For these reasons, the United States requests the Appellate Body to reject the European 
Communities' claim that Article 23.2(a) of the DSU required the United States to initiate an 
Article 21.5 panel proceeding for purposes of examining the WTO-consistency of 
Directive 2003/74/EC.  The United States neverthele ss observes that the Appellate Body need not 
address the European Communities' claims in this re gard if it reverses the Panel's findings that the 
United States has acted inconsistently with Articles 23.1 and 23.2(a) of the DSU, as requested by the 
United States in its other appeal.250 
3. Article 22.8 of the DSU  
108. The United States maintains that the Panel corr ectly interpreted Article 22.8 of the DSU in 
finding that it requires not just the  pro forma  removal of the measure found to be inconsistent, but 
the achievement of actual compliance with the DSB's recommendations and rulings, before the 
application of the suspension of concessions must be terminated. 
109. The United States alleges that, in replacing Directive 96/22/EC with Directive 2003/74/EC,
                                                      
246United States' appellee's submission, para. 134. 
247Ibid. 
248Ibid., para. 115 (quoting Article 31(3)(b) of the Vienna Convention on the Law of Treaties (the 
"Vienna Convention "). 
249Ibid., para. 135. 
250Ibid., para. 125 (referring to United States' other appellant's submission, sections II and III).  See also 
infra , paras. 188-194. WT/DS321/AB/R 
Page 46  
 
the European Communities simply switched the legal instruments unde rlying the import ban and, in 
so doing, failed to remove the inconsistent measure  within the meaning of Article 22.8.  The United 
States contends that the phrase "until such time as th e measure found to be inc onsistent with a covered 
agreement has been removed" in Article 22.8 requir es the elimination of the WTO-inconsistency, that 
is, actual compliance.  The United States notes that the ordinary meaning of "removed" is "lifted, 
taken away".
251  The United States explains that it is di fficult to see how a WTO-inconsistent measure 
can be said to be taken away if an equivalent m easure is put in its place.  The United States further 
argues that the context provided by other provisions of the DSU—namely, Articles 21.1, 21.5, 22.1, and 22.2—confirm that it is actual compliance that  is required by Article 22.8.  These provisions 
indicate that the drafters of the DSU "contempl ated that suspension of concessions and 'full 
implementation' were alte rnatives to one another".
252  The United States adds that interpreting 
Article 22.8 as requiring actual compliance is also supported by the purpose of the suspension of 
concessions, which is to induce compliance.   
110. The United States rejects the European Communities' contention that Articles 21 and 22 of 
the DSU establish a "basic dichotomy" between "t he measure found to be inconsistent" and the 
"measures taken to comply", arguing that the Eur opean Communities draws an "artificial distinction" 
between the "removal of a measure" and "existence or consistency" of a measure taken to comply.253  
The United States draws attention to Article 3.7 of the DSU as reflecting the object and purpose of the 
DSU.  Article 3.7 provides that "the first objectiv e of the dispute settlement mechanism is usually to 
secure the withdrawal of the measures concerned" , which the United States understands as referring 
"not to ... a mere repeal of a measure that is replaced by another, but ... instead to an actual 
elimination of the measure that brings about compliance".254  According to the United States, the 
removal of an inconsistent measure, accompanied by the taking of a measure that undermines such 
removal, results in the absence of a measure taken to comply.   
111. Moreover, the United States disagrees with the European Communities' contention that 
Article 22.8 requires the suspension of concessi ons to be terminated "in the presence of an 
implementation [measure]" that has not yet been f ound to be WTO-inconsistent through Article 21.5 
                                                      
251United States' appellee's submission, para. 102 (quoting The New Shorter Oxford English Dictionary , 
4th edn, L. Brown (ed.) (Clarendon Press, 1993), Vol. 2, p. 2543). 
252Ibid., para. 103. (emphasis omitted) 
253Ibid., para. 104 (quoting European Communities' appellant's submission, paras. 136-142). 
254Ibid., para. 106. (emphasis omitted)  WT/DS321/AB/R 
 Page 47 
 
 
proceedings.255  The United States submits that this conten tion is not supported by Article 22.8, which 
does not state that the suspension of concessions sh all only be applied "until the measure found to be 
inconsistent is   claimed  to have been removed".256  The United States also rejects the European 
Communities' argument that the Panel, in find ing that Directive 96/22/EC was replaced by 
Directive 2003/74/EC, failed to consider that Dir ective 96/22/EC ceased to exist upon the adoption of 
Directive 2003/74/EC, and that the latter contains changes to the justification for the import 
restrictions imposed by the former.  According to the United States, the Panel's approach was 
consistent with the Appellate Body's treatment in EC – Hormones  of Directive 96/22/EC as a 
substitute for the previous Directives that ha d "ceased to exist" when they were replaced by 
Directive 96/22/EC, despite changes made by that Di rective to the import restrictions imposed by the 
previous Directives.257   
112. Furthermore, the United States alleges that th e European Communities' logic, according to 
which an original complainant must terminat e its suspension of concessions and initiate an 
Article 21.5 proceeding when an original respondent claims compliance, will lead to "a strange and 
absurd result".258  If the Article 21.5 panel concludes that compliance has not been achieved, there is 
neither a renewed reasonable period of time nor anot her opportunity to request authorization for the 
suspension of concessions.   
113. On this basis, the United States requests th e Appellate Body to reject the European 
Communities' appeal of the Panel's findings that Ar ticle 22.8 of the DSU requires the achievement of 
actual compliance with the DSB's recommendations and rulings before the application of the 
suspension of concessions must be terminated. 
4. The Panel's Terms of Reference  
114. The United States disagrees with the European Communities' claim that the Panel exceeded 
its terms of reference by assuming the powers of an Article 21.5 panel.   
115. The United States observes that, pursuant to Article  7.1 of the DSU, a panel's standard terms 
of reference cover the matter referred to in the re quest for the establishment of a panel.  The United
                                                      
255United States' appellee's submission, para. 114 (re ferring to European Communities' appellant's 
submission, para. 98).  As regards the European Commun ities' argument that it had suspended retaliatory action 
during the Article 21.5 proceedings in US – FSC , the United States contends that the European Communities 
continues to suspend concessions in US – Offset Act (Byrd Amendment) without initiating an Article 21.5 
proceeding, even though the United States has notified the DSB of the repeal of the Continued Dumping and 
Subsidy Offset Act of 2000. ( Ibid.) 
256Ibid., para. 115. (original emphasis) 
257Ibid., para. 111. 
258Ibid., para. 117. WT/DS321/AB/R 
Page 48  
 
States notes that, in its panel request, the Europ ean Communities specifically asked the Panel to 
consider its complaint with a view to finding that  the United States had acted inconsistently with 
Article 22.8 of the DSU.  Article 22.8 thus fell with in the Panel's terms of reference, and the Panel 
was free to develop its own legal reasoning when addressing the claims raised by the European Communities under Article 22.8.   
116. For the United States, the Panel's finding th at the European Communities' claims under 
Article 22.8 were premised on the actual co mpliance of Directive 2003/74/EC with the 
SPS Agreement  was based on a correct interpretation of Article 22.8 and was supported by the text, 
context, and object and purpose of the DSU.  Furt hermore, the United States rejects the European 
Communities' reference to the panel report in  EC – Sardines  as "inapposite", noting that, unlike in 
this dispute, following the order of analysis requested  by the complainant in th at dispute did not lead 
to an error of law.
 259 
117. Accordingly, the United States requests the Appellate Body to reject the European 
Communities' assertion that the Panel exceeded its term s of reference under Articles 7 and 21.5 of the 
DSU by examining the compatibility of Directive 2003/74/EC with the  SPS Agreement .  The United 
States maintains that the Panel in fact limited its terms of reference improperly on the basis of the 
manner in which the European Communities presented its claims.260 
5. The Panel's Suggestion for Implementation  
118. The United States asserts that the Appellate B ody should decline the European Communities' 
request to improve the Panel's suggestion for impl ementation.  The United States disagrees with the 
European Communities' contention that "the Panel's suggestions require that the United States remove 
the suspension of concessions, and initiate and conclude an Article 21.5 compliance panel 
proceeding."261  The United States underscores that, on the cont rary, the Panel declined to suggest that 
the United States discontinue its suspension of conc essions despite its finding that the United States 
has committed procedural violations under Articles 23 .2(a) and 23.1 of the DSU.  The United States 
considers that a suggestion on im plementation is "inappropriate"262, because it is for a WTO Member 
to decide on the steps needed to bring itself into c onformity.  In addition, the United States argues that 
the Appellate Body should reject the European  Communities' request to improve the Panel's 
suggestion, because improvement of panels' suggesti ons is not within the Appellate Body's mandate,
                                                      
259United States' appellee's submission, para. 122 (re ferring to European Communities' appellant's 
submission, para. 68, in turn referring to Panel Report, EC – Sardines , paras. 7.17 and 7.18). 
260See also infra , para. 196. 
261United States' appellee's submission, para. 136. (footnote omitted) 
262Ibid., para. 139.  WT/DS321/AB/R 
 Page 49 
 
 
which is circumscribed by Articles 17.6 and 17.13 of the DSU.  The United States observes that, in 
any event, the Appellate Body would not need to a ddress this issue if it were to reverse the Panel's 
findings of procedural violations under Articles 23. 1 and 23.2(a), as requested by the United States in 
its other appeal. 
6. The Panel's Selection of Experts  
119. The United States argues that the European Co mmunities is "[r]ecycling yet another of its 
failed challenges from its appeal in EC – Hormones "263 by objecting to the expert selection process in 
its appeal.  The United States explains that, in EC – Hormones , the Appellate Body found no fault 
with the panel because it had consulted with the par ties regarding the selection of experts.  The United 
States describes the steps taken by the Panel in this  case to consult with the parties on expert selection, 
and concludes that the Panel's conduct in the select ion of experts was transparent and consultative, 
providing the parties with notice and opportunities to respond, express their concerns, and be heard 
before the Panel made its decisions.  Moreover, th e United States asserts that the Panel "obtain[ed] 
self-disclosure information from all of the experts, including from Dr. Boisseau".264 
120. Noting the assertion by the European Communities th at the relevant legal test was "likelihood 
or justifiable doubts" as to an expert's independenc e or impartiality, the United States argues that 
"[t]he fact of the matter is that the Panel and th e parties were provided with full disclosure of the 
experts' professional affiliations and financial interests" and "[t]he record demonstrates that the Panel 
took the [European Communities'] concerns into account in concluding that the two experts in 
question were not disqualified from serving."265   
121. The United States alleges that the European Communities provides no support for the claims 
regarding due process rights, arguing that the Eu ropean Communities cited nothing more "than the 
most general statement" by the Appellate Body in Thailand – H-Beams  and a judgment by the 
European Court of Human Rights that the European  Communities "recycled from its challenge to the 
panel's expert selection process in EC – Hormones ".266  In the United States' view, neither of  
those citations supports the European Communities' claim.  Finally, to th e extent the European 
Communities alleges a breach of Article 11 of the DSU, the United States argues that the Panel acted 
within the proper bounds of its discretion as fact-finder. 
122. Consequently, the United States requests th e Appellate Body to reject the European
                                                      
263United States' appellee's submission, para. 83. 
264Ibid., para. 86. (footnote omitted) 
265Ibid., paras. 87 and 88. 
266Ibid., para. 89. WT/DS321/AB/R 
Page 50  
 
Communities' claim that the Panel acted inconsis tently with the principle of due process, the 
requirements in the Rules of Conduct , and its duties under Article 11 of the DSU, in selecting 
Drs. Boisseau and Boobis, and to reject the request  to reverse the Panel's findings that relied on the 
advice of these two experts. 
7. Article 5.1 of the  SPS Agreement
 
123. The United States argues that the Panel was correct in finding that the European 
Communities' permanent ban on meat and meat pr oducts from cattle treated with oestradiol-17 β for 
growth-promoting purposes was not based on a risk asse ssment within the meaning of Article 5.1 of 
the SPS Agreement.   The United States requests the Appellate Body to dismiss the European 
Communities' appeal for the following reasons.  
124. The United States rejects the European Comm unities' argument that the Panel erred by 
excluding, on an  a priori  basis, the European Co mmunities' evidence regard ing misuse and abuse in 
the administration of oestradiol-17 β.  The United States considers that the "core"267 of the European 
Communities' argument is that, because misuse and abuse in the administration of oestradiol-17 β 
might occur one day, the European Communities is justified in banning oestradiol-17 β entirely.  
Contrary to the European Communities' argument, the Panel "fully appreciated"268 the significance of 
the European Communities' asserti on that misuse and abuse in the administration of oestradiol-17 β 
can add to the risks identified in relation to this s ubstance.  However, the Panel correctly considered 
that additional risks arising from misuse and abuse w ould only be relevant for its analysis if the 
European Communities had succeeded in demonstr ating that a specific risk arose from the 
consumption by humans of residues of oestradiol-17 β in meat.  Hence, the United States asserts that, 
consistent with the Appella te Body's findings in  EC – Hormones , the Panel did not  a priori  exclude 
misuse and abuse from the scope of application of Articles 5.1 and 5.2 of the  SPS Agreement .  
Rather, the Panel acknowledged the fact that the Eu ropean Communities had taken those factors into 
account, recognized that such factors were not rele vant to the initial inquiry regarding whether a 
specific risk had been identified, and pr ovided a detailed account of its reasoning. 
125. The United States maintains further that the Panel correctly held that the European 
Communities had not evaluated specifically the risks arising from the consumption of meat and meat 
products containing residues of oestradiol-17 β as a result of cattle being treated with hormones for 
growth-promotion purposes.  The Panel's examinat ion of whether the European Communities had 
demonstrated the potential for adverse effects arising specifically from the presence of hormone 
                                                      
267United States' appellee's submission, para. 53. 
268Ibid., para. 54 (referring to European Communities' appellant's submission, paras. 319 and 331).   WT/DS321/AB/R 
 Page 51 
 
 
residues in meat was based on a "careful tracing"269 of the Appellate Body's interpretation of a "risk 
assessment" under Article 5.1, as defined by Annex A, paragraph 4, to the  SPS Agreement .  The 
United States rejects the European Communities' assertion that the Panel's articulation of the 
"specificity" test would require the demonstration of actual effects in humans.  Rather, it is possible to 
perform tests on laboratory animals and extrapolat e the results to human beings, and the European 
Communities recognizes that other countries have found ways to evaluate the possibility of adverse 
effects arising from the consumption by humans of ho rmone residues in meat by performing tests on 
laboratory animals.  The United States also contends  that "one expert's statement, divorced from the 
rest of the evidentiary record" is not sufficient to demonstrate that the European Communities has 
evaluated the specific risk arising from residues of oestradiol-17 β in meat.270  Instead, the evidentiary 
record supported the Panel's conclusion that the European Communities had identified only "general 
risks"271 and had failed to address the specific risk as required by the  SPS Agreement , that is, the 
"possibility that these adverse effect s come into being, originate, or result from the consumption of 
meat or meat products which contain veterinary residues of oestradiol-17 β as a result of the cattle 
being treated with the hormone for growth promotion purposes."272  The Panel's finding that the 
European Communities had failed to show the specifi city required of a risk assessment resulted from 
an analytical process that was appropriately grounde d in the precepts of scientific inquiry and prior 
Appellate Body reports. 
126. In addition, the United States refutes the Eur opean Communities' argument that the Panel 
required the quantification of risks by focusing its  inquiry on whether the European Communities had 
demonstrated the "potential occurrence of these adverse effects".273  According to the United States, 
the Panel did not preclude that a qualitative risk  assessment could be sufficient for purposes of 
Article 5.1.  Instead, the Panel's reference to "pot ential occurrence" of risks focused on whether the 
European Communities' risk assessment was "s ufficiently specific to the case at hand".274  The United 
States asserts that the Panel's finding that the Eur opean Communities' risk ass essment did not have the 
required specificity is a finding of fact, which the European Communities cannot succeed in 
                                                      
269United States' appellee's submission, para. 57.  
270Ibid., para. 60 (referring to European Communities' appellant's submission, para. 342, in turn 
referring to reply of Dr. Guttenplan to Question 13 posed by the Panel to the scientific experts, Panel Report, 
US – Continued Suspension , para. 7.523, and Panel Report, Canada – Continued Suspension , para. 7.495). 
271Ibid., para. 61.  
272Ibid., para. 65 (quoting European Communities' appellant's submission, para. 344, in turn quoting 
Panel Report, US – Continued Suspension , para. 7.537 (emphasis added by the European Communities 
omitted)). 
273Ibid., para. 62 (quoting Panel Report, US – Continued Suspension , para. 7.521).   
274Ibid., para. 64 (quoting Appellate Body Report, EC – Hormones , para. 200).  WT/DS321/AB/R 
Page 52  
 
disturbing on the basis of its allegation that th e Panel imposed some kind of "'quantification' 
requirement".
275  
127. The United States argues furthermore that the Panel did not err in allocating the burden of 
proof under Article 5.1 of the  SPS Agreement.   The Panel properly noted that "one of the 
particularities of this case"276 was that the European Communities' claim under Article 22.8 of the 
DSU was premised on the assertion by the European Communities that it had brought itself into 
conformity with the  SPS Agreement  through Directive 2003/74/EC.  For this reason, and taking into 
account the European Communities' concern that it s hould not be required to "prove a negative", the 
Panel was justified in allocating to the Eur opean Communities the burden of establishing a  prima 
facie  case of conformity with the  SPS Agreement , including Article 5.1 of that Agreement.  Once the 
Panel found that the European Communities had established such a  prima facie  case, the burden of 
proof shifted to the United States.  The Panel then rightly found that the United States had rebutted the 
European Communities'  prima facie  case of consistency through pos itive evidence of breach of the 
SPS Agreement .  The United States agrees with the Panel's finding that, consistent with the 
"particularities"277 of the European Communities' claim under Article 22.8, "the burden shifted back 
and forth between the parties and eventually 'neutr alized' each other since each party also submitted 
evidence in support of its allegations."278  The United States further agrees with the Panel's approach 
that it would "weigh all the evidence before it"279 in considering whether an allegation had been 
proven.  In so doing, the Panel did not state or consider that it had placed the burden of proof on the 
European Communities.  
128. The United States argues that the Panel did not fail to conduct an objective assessment of the 
matter, as required by Article 11 of the DSU, in reaching its finding that the European Communities' 
permanent ban on oestradiol-17 β was not based on a risk assessment within the meaning of 
Article 5.1.  According to the United St ates, the more deferential "reasonableness"280 standard that the 
European Communities posits should apply to "me asures adopted by governments or specialised 
agencies in highly complex or technical matters"281 finds no support in the text of the  SPS Agreement .  
This Agreement "does not prescribe a particular st andard of review or in clude specific provisions 
addressing the review by a panel of a determin ation or examination conducted by a national 
                                                      
275United States' appellee's submission, para. 66. 
276Ibid., para. 93 (quoting Panel Report, US – Continued Suspension , para. 7.384). 
277Ibid., para. 94. 
278Ibid. (referring to Panel Report, US – Continued Suspension , para. 7.386). 
279Ibid. (quoting Panel Report, US – Continued Suspension , para. 7.386). (emphasis omitted) 
280Ibid., para. 36 (referring to European Commun ities' appellant's submission, para. 223).  
281Ibid., para. 37 (quoting European Communities' appellant's submission, para. 223).   WT/DS321/AB/R 
 Page 53 
 
 
authority".282  Moreover, the United States recalls that the Appellate Body rejected the European 
Communities' attempt to introduce a "def erential 'reasonableness' standard" in EC – Hormones , 
finding that "[t]o adopt a standard of review not clearly rooted in the text of the  SPS Agreement  
itself, may well amount to changing that finely  drawn balance" between the jurisdictional 
competences conceded by WTO Members and the ju risdictional competences retained by Members 
for themselves.283   
129. The United States additionally rejects the Europ ean Communities' argument that panels must 
apply the "generally appli cable standard of review"284 differently, depending upon the specific 
provision of the  SPS Agreement  that is being applied to the facts.  The United States recalls the 
standard of review proposed by the European Comm unities for a claim arising under Article 5.1 of the 
SPS Agreement , according to which a panel must defer to a Member's risk assessment "if the evidence 
before the panel provides for at least one scientific ally plausible set of conclusions under which an 
adverse effect might occur."285  In the United States' view, the European Communities' formulation 
has no support in the covered agreements and "confla tes the concept of 'standard of review' and the 
application of law to facts".286  On this basis, the United States submits that the standards of review 
proposed by the European Commun ities "are products of [its own] wishful thinking and find no 
support in the DSU, the  SPS Agreement , or the findings of the Appellate Body".287 
130. The United States observes that the Appellate Body has consistently held that the standard of 
review to be applied by panels to their fact-finding in SPS disputes is "neither  de novo  review, as 
such, nor 'total deference', but rather the 'objective assessment of the facts'".288  The United States 
emphasizes that a panel will be regarded as having failed to make an objec tive assessment where it 
"deliberately disregards", "refuses to consider", or "wilfully distorts or misrepresents" evidence 
submitted to it.289  This requires "more than just an error of  judgement in the appreciation of evidence, 
but rather an 'egregious error that calls into question the good faith of a panel'".290  Moreover, panels 
"enjoy a 'margin of discretion' as triers of fact" and are "not required to accord to factual evidence of 
                                                      
282United States' appellee's submission, para. 34 (referring to Appellate Body Report, EC – Hormones , 
paras. 114-116).  
283Ibid., para. 37 (quoting Appellate Body Report, EC – Hormones , para. 115).  
284Ibid., para. 38.  
285Ibid., para. 38 (quoting European Communities' appellant's submission, para. 229).  
286Ibid., para. 39.  
287Ibid., para. 39. 
288Ibid., para. 40 (quoting Appellate Body Report, EC – Hormones , para. 117).  
289Ibid., para. 41 (quoting Appellate Body Report, EC – Hormones , para. 133).   
290Ibid., para. 41 (quoting Appellate Body Report, EC – Hormones , para. 133).  WT/DS321/AB/R 
Page 54  
 
the parties the same meaning and weight as do the pa rties", and may properly "determine that certain 
elements of evidence should be accorded more weight than other elements".
291 
131. The United States rejects the European Commun ities' contention that the Panel exceeded the 
bounds of its discretion under Article 11 of the DSU in its appreciation of the evidence.  The Panel's 
statement that "its situation [was] similar"292 to that of a risk assessor does not support the European 
Communities' allegation that the Panel impermissibly conducted a  de novo  review.  Rather, the Panel 
considered itself to be in a situation "similar" to th at of a risk assessor insofar as it would benefit from 
hearing a full spectrum of scientific experts to obtain a complete picture of both mainstream and 
divergent scientific views.293  The United States also dismisses th e European Communities' allegation 
that the Panel exceeded the bounds of its discretion in choosing to rely on the views expressed by the 
"majority of experts", or on the "most specific" or "best supported" view.294  The United States asserts 
that the Panel's exercise of judgement in evaluati ng the evidence was "part and parcel of the Panel's 
duty to make an objective assessment of the facts".295  Moreover, the Panel could not have realistically 
referred to all statements made by the experts advi sing it and should have had a substantial margin of 
discretion as to which statements to refer to exp licitly.  The United States submits that the Panel's 
findings in relation to:  (i) exposure to hormones from multiple sources;  (ii) the genotoxicity of 
oestradiol-17 β;  (iii) the specificity of the risk assessment;  and (iv) the role of misuse and abuse of 
hormones as factors in a risk assessment were all w ithin the bounds of its discretion as the trier of 
facts and should therefore be upheld by the Appellate Body.   
132. The United States additionally contends that the European Communities' challenges raised 
under Article 11 of the DSU to the Panel's fact-findi ng appear to be claims that the Panel breached 
Article 12.7 of the DSU by failing to set out the findings of fact, the applicability of relevant 
provisions, and the basic rationale underlying its findings.  However, no such claim of error under 
Article 12.7 has been made by the European Commun ities on appeal.  For this reason, to the extent 
that the European Communities' ch allenges raised under Article 11 shoul d properly have been raised 
under Article 12.7 instead, those claims should be disr egarded as not properly subject to review by the 
Appellate Body. 
                                                      
291United States' appellee's submission, para. 42 (quoting Appellate Body Report, Japan – Apples , 
para. 221, in turn quoting Appellate Body Report, EC – Asbestos , para. 161, and Appellate Body Report, 
Australia – Salmon , para. 267).  
292Ibid., para. 44 (quoting Panel Report, US – Continued Suspension , para. 7.418).  
293Ibid., para. 44.  
294Panel Report, US – Continued Suspension , para. 7.420;  Panel Report, Canada – Continued 
Suspension , para. 7.411. 
295United States' appellee's submission, para. 47.   WT/DS321/AB/R 
 Page 55 
 
 
133. The United States concludes that the Panel did not err in finding that Directive 2003/74/EC is 
inconsistent with Article 5.1 of the  SPS Agreement , and requests the Appellate Body to reject the 
European Communities' appeal concerning the Panel's findings.   
8. Article 5.7 of the  SPS Agreement  
134. The United States argues that the Panel correctly found that the relevant scientific evidence 
on the five hormones subject to the provisional ban was not "insufficient" within the meaning of 
Article 5.7 of the  SPS Agreement.   The United States requests the A ppellate Body to dismiss this 
ground of the European Communities'  appeal for the following reasons. 
135. The United States argues that the Panel correctly interpreted Article 5.7, taking account of the 
context provided by Articles 3.2 and 3.3 of the  SPS Agreement .  The United States recalls that, 
pursuant to Article 3.2, a measure conforming to an  international standard shall be deemed to be 
consistent with the relevant provisions of the  SPS Agreement .  Thus, the Panel was justified in 
finding that the existence of international standa rds demonstrated that there had been sufficient 
scientific evidence to conduct a risk  assessment within the meaning of Article 5.1.  Indeed, it would 
not make sense that the  SPS Agreement  would require a measure conforming to an international 
standard to be deemed consistent  with Article 5.1 if the international standard was not based on a 
proper risk assessment.  In any event, the Un ited States charges the European Communities with 
failing to take into account that, " in this case , the international standards for the hormones in question 
are unquestionably supported by proper risk assessments."296  
136. The United States contends furthermore that th e European Communities' desired level of SPS 
protection was irrelevant for the Panel's determ ination of whether the scientific evidence was 
"insufficient" within the meaning of Article 5.7.  First, the United States submits that the European 
Communities had failed to show that its appropriate level of protecti on is different from the level of 
protection that the Codex standards are designed to achieve.  Secondly, the United States notes that a 
risk assessment is a scientific process aimed at iden tifying whether a risk exists, and risk assessors 
"need not have any particular level of prot ection in mind in conducting the risk assessment".297  
Therefore, the question of whether the relevant scien tific evidence is "insuffici ent" within the meaning 
of Article 5.7 is a matter entirely separate "fro m the 'appropriate level of [SPS] protection'"298 that a 
Member chooses to set.  In addition, the Un ited States considers rema rkable the European 
Communities' statement that "[s]cience is essentiall y about measuring past fact and hypothesizing 
                                                      
296United States' appellee's submission, para. 70. (original emphasis) 
297Ibid., para. 72.  
298Ibid., para. 73.  WT/DS321/AB/R 
Page 56  
 
about the future, including postulating about future risk."
299  The United States argues that this 
statement reveals the European  Communities' "fundamental misunderstanding of science", because 
the scientific method is about "rigorously testin g a hypothesis using experimentation rather than 
'measuring past fact' or 'hypothesizing about the future'".300 
137. The United States maintains that the Panel did not err in finding that a "critical mass of new 
evidence" is required to render previously suffici ent scientific evidence "ins ufficient" within the 
meaning of Article 5.7.  The United States obser ves that the Panel did not impose a quantitative 
requirement by referring to the "critical mass" of ne w evidence.  Instead, the Pa nel used this term to 
indicate "a situation where evidence becomes so qua ntitatively and qualitatively sufficient to call into 
question the fundamental precepts of previous kno wledge and evidence", such that new scientific 
information is "at the origin of a change  in the understanding of a scientific issue".301  The United 
States points out that the five hormones subject to the provisional ban had been studied intensively for 
decades and the international standards for four of  them had existed for over 20 years.  The United 
States additionally recalls that, in EC – Hormones , the European Communities argued that the 
scientific evidence concerning the same five hormones had been "sufficient to justify its legislation 
and [it] [had] not need[ed] to rely on the exception provided for in Article 5.7 concerning cases where 
relevant scientific evidence was insufficient."302  Under these circumstances, it was "appropriate" for 
the Panel to focus on the question of "w hether relevant scientific evidence had  become  
insufficient".303  The United States adds that there w as "plentiful" evidence in the record 
demonstrating that the relevant sci entific evidence "[was] and remains sufficient" to conduct a risk 
assessment for the five hormones.304 
138. The United States asserts that the Panel correctly allocated the burden of proof in its analysis 
under Article 5.7.  As it argu es in respect of Article 5.1305, the United States submits that the Panel 
properly noted that "one of the particularities of this case"306 was that the Euro pean Communities' 
claim under Article 22.8 of the DSU was premised on  an assertion by the Eu ropean Communities that 
it had brought itself into conformity with the  SPS Agreement  through the adoption of 
Directive 2003/74/EC.  For this re ason, and taking into account the European Communities' concern 
that it should not be required to "prove a negativ e", the Panel was justified in allocating on the 
                                                      
299United States' appellee's submission, para. 74 (quoting European Communities' appellant's 
submission, para. 398).  
300Ibid., para. 74. 
301Ibid., para. 78 (quoting Panel Report, US – Continued Suspension , para. 6.141). (emphasis omitted) 
302Ibid., para. 80 (quoting Panel Report, EC – Hormones (US) , para. 4.239). 
303Ibid. (original emphasis) 
304Ibid., para. 81.  
305See supra , para. 127. 
306United States' appellee's submission, para. 93 (quoting Panel Report, US – Continued Suspension , 
para. 7.384;  and Panel Report, Canada – Continued Suspension , para. 7.381).  WT/DS321/AB/R 
 Page 57 
 
 
European Communities the burden of establishing a  prima facie  case of conformity with the  SPS 
Agreement , including with Article 5.7 of that Agreement.   The United States agrees with the Panel 
that "the burden shifted back a nd forth between the parties and ev entually 'neutralized' each other 
since each party also submitted evid ence in support of its allegations."307  The United States further 
agrees with the Panel's approach that it would "weigh all the evidence before it"308 in considering 
whether an allegation had been proved.  Furthermor e, the United States observes that "the Panel did 
not state or consider that it had placed the burden of proof on the [European Communities]."309  Thus, 
the United States dismisses as "speculation"310 the European Communities'  assertion that the Panel 
treated Article 5.7 as an exception to Article 5.1.   
139. Finally, the United States argues that the Panel did not fail to conduct an objective assessment 
of the facts as required by Article 11 of the DSU in reaching its findings under Article 5.7 of the  SPS 
Agreement .  As noted earlier311, the United States argues that the "reasonableness approach"312 that the 
European Communities posits should apply to "me asures adopted by governments or specialised 
agencies in highly complex or technical matters"313 has no support in the text of the  SPS Agreement .  
Moreover, the United States submits that the Panel did not conduct a  de novo  review and, instead, 
acted within the bounds of its discretion by attri buting to the different pieces of evidence a different 
weight and significance than that attr ibuted by the European Communities.314  As regards certain 
statements by the experts concerning the "sufficien cy" of the relevant scientific evidence on which the 
European Communities relies, the Un ited States asserts that these statements "were all made at the 
conclusion of the Panel's meeting with the experts when the experts were given the opportunity to 
make general, conc luding remarks on the previous two days".315  According to the United States, the 
experts were not instructed to limit their remarks to  certain hormones and, in fact, the statements of 
the experts quoted by the European Commun ities either explicitly addressed oestradiol-17 β or did not 
specify to which of the hormones the experts' statements made reference.316  The United States 
reiterates that "there was plentiful evidence in the record demonstrating that the relevant scientific 
                                                      
307United States' appellee's submission, para. 94 (referring to Panel Report, US – Continued Suspension , 
para. 7.386). 
308Ibid. (quoting Panel Report, US – Continued Suspension , para. 7.386;  and Panel Report, Canada – 
Continued Suspension , para. 7.383). (emphasis omitted) 
309Ibid., para. 96. 
310Ibid. 
311See supra , para. 128. 
312United States' appellee's submission, para. 37 (r eferring to European Communities' appellant's 
submission, para. 223).  
313Ibid. (quoting European Communities' appellant's submission, para. 223).  
314See supra , paras. 130 and 131. 
315United States' appellee's submission, para. 81. 
316Ibid. (referring to statements by Drs. Sippell, Guttenplan, Cogliano, and Boisseau, quoted in 
European Communities' appellant's submission, paras. 422, 423, 424, and 425, respectively). WT/DS321/AB/R 
Page 58  
 
evidence"
317 remains sufficient to conduct a risk ass essment for these five hormones, including 
statements by the experts acknowledging that the data  were sufficient to conduct risk assessments for 
the five hormones subject to the provisional ban.  Thus, the United States concludes that the Panel's 
consideration of whether there was a "'critical mass of new evidence' was proper and well-supported".
318  Finally, the United States maintains that , to the extent the European Communities' 
challenges raised under Article 11 of the DSU "shoul d properly have been raised under [Article 12.7 
of the DSU] instead, those claims should be disr egarded as not properly subject to review by the 
Appellate Body."319 
140. The United States concludes that the Panel did not err in finding that Directive 2003/74/EC is 
inconsistent with Article 5.7 of the  SPS Agreement , and requests the Appellate Body to reject the 
European Communities' appeal concerning the Panel's findings.   
C. Arguments of Canada – Appellee  
1. Procedural Issue – Public Observation of the Oral Hearing  
141. Canada requests that the Appellate Body open the hearing in these proceedings to public 
observation.  Canada observes that, if "[r]ead out of  context", the first sentence of Article 17.10 "may 
appear to require closed oral h earings before the Appellate Body".320  However, Canada argues that 
when the key terms of the sentence—"proceedings" and "confidential"—are pr operly interpreted in 
accordance with the customary rules of treaty interpretation, in the context of the entire DSU and, in 
particular, Article 17 itself, it can be seen that th e sentence does not, and was not intended to, operate 
as a bar to open hearings.   
142. In Canada's submission, the term "proceedi ngs" in Article 17.10 "encompasses the entire 
appellate process".321  As regards the term "confidential", Ca nada states that an examination of the 
context of Article 17.10 and the practice of WTO di spute settlement demonstrates that this provision 
does not require that the entire appellate process must  remain strictly secret and out of the public's 
knowledge.  Canada adds that if Ar ticle 17.10 required absolute confidentiality, then all of the steps 
within an appeal would have to remain out of  the public knowledge, including the initial Notice of 
Appeal and the final Appellate Body report.  Ho wever, both of these documents are made public upon
                                                      
317United States' appellee's submission, para. 81 (referring to comments by the United States on the 
replies of the scientific experts, Codex, JECFA, and IARC to questions posed by the Panel, Panel Reports, 
Annex F, paras. 47 and 48). 
318Ibid., para. 82. 
319Ibid., para. 49.  
320Canada's request for an open hearing, para. 4.   
321Ibid., para. 5.  WT/DS321/AB/R 
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circulation.  Moreover, Appellate Body reports,  which are made public, include summaries of the 
participants' written submissions and refer to the part icipants' arguments made during the oral hearing.  
Canada thus concludes that many aspects of the A ppellate Body's proceedings during the "substantive 
portion"322 of the appellate process are actually revealed to the public and are not subject to 
confidentiality under Article 17.10. 
143. Canada also draws attention to Article 18.2 of th e DSU, which "permits parties to reveal their 
positions to the public".323  Canada asserts that, "[a]s was recognized by the Panel, all three parties, by 
making a unanimous request for a public oral heari ng in these two parallel appeals, are relying on 
their right, stated in ... Article 18.2, to make their oral arguments public."324  Canada adds that 
Article 18.2 does not prescribe a specific means of making a party's arguments public and, consequently, it does not matter whether such ri ght is exercised after the oral hearing or 
contemporaneously with the oral hearing. 
144. Canada submits that the  Rules of Conduct  "do not present an obstacle"
325 to the Appellate 
Body holding open hearings.  Furthermore, Cana da considers that, under Rule 16(1) of the  Working 
Procedures , "[t]he Appellate Body has discretion ... to  respond favourably to the unanimous request 
by all three parties to the appeal in this c ase and to open the oral hearing to the public."326 
145. Canada additionally asserts that open hearings ar e an important contribution to the legitimacy 
and the perception of legitimacy of the WTO disput e settlement system.  Canada cautions that "[t]he 
legitimacy of the WTO dispute settlement system w ould suffer if the oral hearing at the appellate 
level were to be closed while at th e panel stage the hearings were open."327  
146. In response to the comments of the third participan ts, Canada asserts that the third participants 
that oppose the request to open the hearing seek to divorce the term "proceedings" from its context 
and ignore the meaning of "confidential" altogether.328  Canada further notes that, given the 
entitlement of parties under Article 18.2 to disclo se their written submissions, oral statements, and 
answers to questions, "it would be absurd to find that where those parties ag ree that they wish to 
present their positions at an appellate hearing in open session, they may not do so."329  Canada also 
objects to the argument that the Appellate Body's decision on this issue would prejudge the outcome
                                                      
322Canada's request for an open hearing, para. 7. 
323Ibid., para. 9. 
324Ibid., para. 14. 
325Ibid., para. 15. 
326Ibid., para. 19. 
327Ibid., para. 24. 
328Canada's comments on third participants' comments, para. 8. 
329Ibid., para. 10. WT/DS321/AB/R 
Page 60  
 
of the DSU review negotiations.  This argument, according to Canada, misconstrues the nature and 
scope of the participants' request, because they are not asking the Appellate Body to decide that all 
appellate hearings must be open to the public.  Ca nada observes, moreover, that the argument is 
premised on the incorrect notion that "whenever a matter in dispute settlement is or might be the 
subject of negotiations among the membership, pane ls and the Appellate Body should decline to 
consider the matter lest it 'prejudge' the outcome of the negotiations."
330 
147. Accordingly, Canada requests that the Appellate  Body allow public observation of the hearing 
in these proceedings.  Canada states that, in orde r to accommodate any third participants wishing to 
retain the confidentiality of their oral submissions, a "practical solution" would be to have "a video 
link between the room in which the oral hearing takes place and a second room in which the public 
can watch the oral hearing"331 and to interrupt the broadcast if a third participant so wishes. 
2. Articles 23.2(a) and 21.5 of the DSU  
148. Canada submits that the Panel correctly found th at "recourse to dispute settlement" within the 
meaning of Article 23.2(a) of the DSU is not lim ited to Article 21.5 panel proceedings and that 
Articles 21.5, 23.1, and 23.2(a) did not require Ca nada to initiate a compliance panel proceeding for 
purposes of examining the compatibility of Directive 2003/74/EC with the  SPS Agreement . 
149. According to Canada, the European Communities' characterization of this dispute as a 
"disagreement as to the existence or consistency with a covered agreement of measures taken to 
comply", within the meaning of Article 21.5, "ig nores ... that the essence of this dispute is not 
specifically about a 'disagreement' over the [Eur opean Communities'] alleged compliance measure".332  
Rather, Canada argues that Article 22.8 is the provi sion of the DSU that specifically applies to the 
post-retaliation stage and that it is for the Europ ean Communities, as the party seeking termination of 
the suspension of concessions, to demonstrate th at it has removed its WTO-inconsistent measure 
within the meaning of Article 22.8.  Canada ma intains that the European Communities' unilateral 
assertion of compliance by virtue of Directive 2003/ 74/EC does not compel Canada to initiate an 
Article 21.5 proceeding, and does not require Canada  to lift the suspension of concessions.  Canada 
submits that to allow a unilateral declaration of compliance to displace the multilateral authorization 
to suspend concessions "would contravene the very  rule against unilateralism that the [European 
Communities] accuses Canada of breaching".333   
                                                      
330Canada's comments on third participants' comments, para. 15. 
331Canada's request for an open hearing, para. 29. 
332Canada's appellee's submission, paras. 7 (ref erring to European Communities' appellant's 
submission, para. 49) and 8.   
333Ibid., para. 9.  WT/DS321/AB/R 
 Page 61 
 
 
150. Canada further submits that the European  Communities has the option of initiating an 
Article 21.5 proceeding itself.  This is confirmed by the fact that the panel in EC – Bananas III 
(Article 21.5 – EC)  did not decline jurisdiction, even t hough the proceeding was initiated by the 
European Communities, the respondent in the origin al proceedings.  Canada recalls that the panel 
report in EC – Bananas III (Article 21.5 – EC)  was not adopted because the European Communities, 
the only party that participated in that proceeding,  did not request its adoption.  Consequently, the 
European Communities' assertion that "subsequent practice" confirms that Article 21.5 panel 
proceedings may not be initiated by the orig inal respondent "is without any foundation".334  Canada 
disagrees with the European Communities' argument th at the panel's inability to compel other parties 
to participate in EC – Bananas (Article 21.5 – EC)  shows why an original respondent may not initiate 
Article 21.5 proceedings, because "no panel can ev er compel a party to a dispute to appear"335 in any 
panel proceeding. 
151. Canada asserts that the Panel correctly found that , while recourse to an Article 21.5 panel was 
one of the procedural mechanisms available to th e European Communities to demonstrate that it had 
"removed" its WTO-inconsistent measure and obtai n the termination of Canada's suspension of 
concessions, the European Communities had several ot her procedural avenues available to it.  These 
include good offices and consultations, arbitration under Article 25 of the DSU, and recourse to a 
panel  de novo .  The availability of a new panel proceedi ng is demonstrated by the fact that the 
European Communities initiated the present dispute and put the issue of whether 
Directive 2003/74/EC had brought it into compliance "squarely before the Panel"336 through its 
conditional claims.  Thus, contrary to the Europ ean Communities' assertion that an Article 21.5 panel 
proceeding is the only procedure providing finality to the dispute, the fact that the European Communities put the issue of actual compliance "squar ely" before the Panel in this case demonstrates 
its own belief that the Panel was in a position to ad judicate "the central matter at issue" in this 
dispute.
337 
152. On this basis, Canada requests the Appellate  Body to reject the European Communities' 
appeal regarding the Panel's finding that Articles 21.5 and 23.2(a) did not requir e Canada to initiate an 
Article 21.5 panel proceeding for purposes of examining the WTO-consistency of 
Directive 2003/74/EC. 
                                                      
334Canada's appellee's submission, para. 11 (referring to the European Communities' appellant's 
submission, para. 91). 
335Ibid., para. 12. 
336Ibid., para. 15. 
337Ibid., para. 15. WT/DS321/AB/R 
Page 62  
 
3. Article 22.8 of the DSU
 
153. Canada argues that, contrary to the Europ ean Communities' claims, the Panel correctly 
interpreted Article 22.8 of the DS U by concluding that the phrase " until such time as the measure 
found to be inconsistent with a c overed agreement has been removed"  means that the illegality itself 
must be removed, and not only the originally impugned measure.   
154. According to Canada, the European Communities "advocates an overly narrow and 
formalistic interpretation that fails to situate Article 22.8 in its proper context"338 when arguing that 
the "mere existence"339 of an implementing measure and its s ubsequent notification would be enough 
to satisfy the requirement under Article 22.8 that the WTO-inconsistent measure is removed.  In 
contrast, the Panel properly took into account the context of Article 22.8 when finding that the removal of the inconsistent measure, under the fi rst scenario in Article 22.8, required actual 
compliance with the DSB's recommendations and ru lings before the suspension of concessions could 
be terminated.  Canada maintains that the sec ond and third scenarios requiring termination of the 
suspension of concessions under Article 22.8 "conte mplate situations where the issue of the 
nullification or impairment caused by ... non-complia nce with [the covered agreements] has been 
satisfactorily addressed".
340  Furthermore, Canada asserts that  the Panel correctly found that the 
ongoing surveillance by the DSB of the implemen tation of the recommendations and rulings, as 
provided in the second sentence of Article 22.8, was intended to ensure that Members fully implement 
the DSB's recommendations and rulings .  Canada also submits that surveillance by the DSB would be 
rendered meaningless if its role were to be reduced  to one of a passive observer that would "simply 
take note of the 'existence' of an alleged implementing measure, without ensuring that its 
recommendations and rulings have  indeed been implemented".341  Canada adds that the Panel's 
interpretation was also consistent with the pr inciple of "prompt" compliance with the DSB's 
recommendations and rulings expressed in Articles 21.1 and 3.2 of the DSU.   
155. Canada further submits that the Panel's interpre tation of Article 22.8 w as consistent with the 
object and purpose of the DSU to provide security an d predictability to the multilateral trading system 
as set forth in Article 3.2.  This is because, in Ca nada's view, "Article 22.8 is the linchpin for ensuring 
that the suspension of concessions achiev es the objective of inducing full compliance"342, and 
Article 22.8 should not be interpreted so narrowly as to weaken the effectiveness of the suspension of 
concessions.  Canada contends that  the interpretation of Article 22.8 advocated by the European 
                                                      
338Canada's appellee's submission, para. 21. 
339Ibid., para. 18 (quoting European Communities' appellant's submission, para. 101). 
340Ibid., para. 25. 
341Ibid., para. 26. 
342Ibid., para. 33.  WT/DS321/AB/R 
 Page 63 
 
 
Communities would require the immediate terminat ion of Canada's suspension of concessions upon 
the mere unverified assertion and unilateral declaration of compliance with the DSB's 
recommendations and rulings and woul d require "the initiation by Cana da of new litigation" in order 
not to "displace Canada's multilaterally  authorized suspension of concessions".343  If it is eventually 
established that the alleged implementing measure does not comply with the DSB's recommendations 
and rulings, the Member seeking compliance "will c ontinue to suffer, without any relief, the 
nullification or impairment caused by the failure of the non-compliant Member to bring itself into 
compliance".344  Thus, Canada argues, the interpretation of Article 22.8 advocated by the European 
Communities should be rejected in order to avoid "a cycle of 'recurrent litigation'".345 
156. Canada therefore requests the Appellate Body to  reject the European Communities' appeal of 
the Panel's finding that Article 22.8 of the DSU requires actual compliance with the DSB's 
recommendations and rulings before the susp ension of concessions must be terminated. 
4. The Panel's Terms of Reference  
157. Canada contends that the European Communities'  claim that the Panel exceeded its terms of 
reference when it assumed a role similar to that of a compliance panel confuses the issue of the 
Panel's jurisdiction with the issue of the sequen ce of the European Communities' claims.  Canada 
notes that, under its alternative and conditional claim, the European Communities implicitly 
acknowledged that the Panel had jurisdiction to ex amine the compatibility of Directive 2003/74/EC 
with the  SPS Agreement .  Thus, the real contention underlying  the European Communities' claim that 
the Panel exceeded its terms of reference is not th at the Panel improperly examined the consistency of 
Directive 2003/73/EC with the  SPS Agreement , but, rather, that the Panel did so in addressing the 
European Communities' second series of main claims. 
158. Canada maintains that the Panel correctly f ound that it had no choice but to review the 
consistency of Directive 2003/74/EC with the  SPS Agreement , because the presumption of good faith 
compliance, which the European Communities relie d upon in making its second series of main claims, 
was rebuttable by Canada.  Canada recalls th e Panel's observation that its examination of 
Directive 2003/74/EC under the  SPS Agreement  was "not the result of ... disregarding the order in 
which"346 the European Communities presented its claims, but was done for the purpose of addressing 
the European Communities' second series of main cl aims under Articles 23.1, 22.8, and 3.7 of the 
                                                      
343Canada's appellee's submission, para. 34. 
344Ibid., para. 35. 
345Ibid. (quoting Panel Report, Canada – Continued Suspension , para. 7.230). 
346Ibid., para. 40 (quoting Panel Report, Canada – Continued Suspension , para. 7.357). WT/DS321/AB/R 
Page 64  
 
DSU.  Hence, the Panel's approach was not a resu lt of it disregarding the sequence of the European 
Communities' claims, but the result of a reasoned analysis of the second series of main claims.   
159. Canada further argues that, although the European  Communities' panel request did not refer to 
provisions of the  SPS Agreement , the Panel correctly found that the compatibility of 
Directive 2003/74/EC with the  SPS Agreement  was  ipso facto  an issue before the Panel.  Thus, the 
Panel did not breach Article 7 of the DSU, beca use this provision requires panels to address the 
relevant provisions of the covered agreement cited by the parties.  Canada recalls that the European 
Communities' second series of main claims was prem ised on a violation of Article 22.8 by Canada, 
which in turn depended on a finding that the measure found to be inconsistent with the 
SPS Agreement  in  EC – Hormones  had been removed.  Conseque ntly, Article 22.8 required the 
Panel to consider the consistency of Directive 2003/74/EC with the  SPS Agreement  as a condition 
precedent to a finding of violation by Canada of Artic le 22.8.  In addition, Ca nada maintains that the 
Panel's approach was consistent with  the Appellate Body's finding in  Argentina – Footwear (EC)  
that a panel cannot make an "objective assessment of th e matter" if it only refers in its reasoning to the 
"specific provisions cited by the parties in their claims".
347  Canada observes, moreover, that the Panel 
considered that the issue of the substantive co mpliance of the European Communities' implementing 
measure was raised "early in the proceedings" and th erefore "no party to the dispute could claim that 
it did not have the opportunity to addr ess the legal arguments of the other."348 
160. On this basis, Canada requests the Appellate Bo dy to reject the Eur opean Communities' claim 
that the Panel exceeded its terms of reference unde r Articles 7 and 21.5 of the DSU when examining 
the compatibility of Directive 2003/74/EC with the  SPS Agreement . 
5. The Panel's Suggestion for Implementation  
161. In its appellee's submission, Canada did not a ddress the European Communities' request that 
the Appellate Body modify the Panel's suggesti on for implementation.  However, in its other 
appellant's submission, Canada requests the Appella te Body to reverse the Panel's suggestion for 
implementation, because the suggestion was c ontradictory to the Panel's findings under 
Article 22.8.349 
                                                      
347Canada's appellee's submission, para. 43 (quoting Appellate Body Report, Argentina – Footwear 
(EC) , para. 74). 
348Ibid. (referring to Panel Report, Canada – Continued Suspension , para. 7. 371). 
349See also infra , para. 206.  WT/DS321/AB/R 
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6. The Panel's Selection of Experts  
162. Canada rejects the European Communities' argument that Section VI of the  Rules of Conduct  
sets forth the relevant legal standard.350  Rather, Canada submits that the only standard governing 
conflict of interest questions is found in Section II (Governing Principle) of the  Rules of Conduct .  
That provision requires that all persons covered under the  Rules of Conduct , including experts, "shall 
be independent and impartia l", and "shall avoid direct or indirect  conflicts of interest".  Moreover, 
Canada asserts that Drs. Boisseau and Boobis met the disclosure requirement under the Working 
Procedures for Consultations with Scientific a nd/or Technical Experts  (the "Experts Working 
Procedures") developed by the Panel, and that, in  particular, both complied with the requirements by 
disclosing their involvement in JECFA.  In Canada's  view, "it was up to the Panel to evaluate whether 
this had an impact [on] the independence and impartiality of these candidates in this case."351 
163. Canada submits that the Panel correctly found that Drs. Boisseau and Boobis were 
independent and impartial.  Canada re calls that the Panel "expressly addressed"352 the allegation that 
these two experts were defending their prior work when it explained that the purpose of consulting 
them was to obtain advice about the substance of JECFA's risk assessment, and to help identify the 
extent to which concerns raised by the European  Communities had been considered in JECFA's risk 
assessment.  Canada also highlights the Panel's ex planations that it was asking the experts about 
JECFA's consensual view, which may differ from the experts' personal views, and that both experts 
admitted to the Panel that the state of scientific knowledge can evolve.   
164. Canada observes that the conflict of interest  alleged by the European Communities is not 
covered by the Illustrative List of Information to be Disclosed set out in Annex 2 of the  Rules of 
Conduct .  Therefore, according to Canada, "an expert's  previous participation in JECFA would not put 
the person in a conflict-of-interest situation wh en he or she provides advice to the Panel."353  I n  
Canada's view, participation by these experts both in  JECFA and as advisers to the Panel occurred in a 
personal, independent, professional capacity and for no monetary gain.  More over, Canada submits, it 
is inaccurate to portray participation by Drs. Bo isseau and Boobis in JECF A committees as "giving 
them an (almost proprietary) interest in the outco me of the JECFA process that they would have felt 
compelled to defend when advising the Panel".354  Canada maintains that the JECFA process "is a 
diffuse one, in which a number of scientists par ticipate but the precise outcome is uncertain 
                                                      
350Canada's appellee's submission, para. 47 (referring to European Communities' appellant's 
submission, para. 195). 
351Ibid., para. 49. 
352Ibid., para. 54. 
353Ibid., para. 55. 
354Ibid., para. 56. WT/DS321/AB/R 
Page 66  
 
beforehand".
355  The experts, Canada submits, were cont ributors to a process "aimed at reaching a 
consensus out of what may initially be a variety of  scientific views", which is "very different" from 
scientific conclusions arrived at through the effo rts of, and published by, an individual scientist.356 
165. Canada considers that the practical consequence of the Panel excluding Drs. Boisseau and 
Boobis as experts would have been that "the pool  of eligible experts would have been shrunk 
significantly, such that it would have become very difficult for the Panel to appoint experts in all the 
areas of expertise that it had identified."357  Pointing to an example in which a particular scientist had 
examined issues relating to genetically modified  organisms for both the European Food Safety 
Authority and JECFA, Canada avers that this is c onsistent with its view that independent scientific 
experts serving in their personal capacity may a dvise different international bodies (or national 
bodies) on the same subject matter without compro mising their independence and impartiality.   
166. Canada therefore requests the Appellate Body to  reject the European Communities' claim that 
the Panel acted inconsistently with the princi ple of due process, the requirements of the  Rules of 
Conduct , and Article 11 of the DSU in selecting Drs. Bo isseau and Boobis, and to reject the request to 
reverse the Panel's findings that relied on the advice of these two experts. 
7. Article 5.1 of the  SPS Agreement  
167. Canada argues that the Panel was correct in finding that the European Communities' 
permanent ban on meat and meat products from cattle treated with oestradiol-17 β for growth-
promoting purposes was not based on a risk assessmen t within the meaning of Article 5.1 of the  SPS 
Agreement.   Canada requests the Appellate Body to dismiss the European Communities' appeal.  
168. Canada argues that the Panel correctly interpreted Article 5.1 of the  SPS Agreement , as 
informed by Article 5.2 of the  SPS Agreement , and did not ignore in its analysis the European 
Communities' arguments regarding misuse and abuse in the administration of hormones.  Canada 
maintains that the European Communities did no t provide evidence demonstrating that it had 
evaluated misuse and abuse in the administration of oestradiol-17 β as a specific risk in relation to the 
consumption of meat from cattle treated with  this hormone for growth-promotion purposes.  
Therefore, "it is even unreasonable to presume misuse/abuse of hormones"358 for purposes of the 
Panel's examination of Article 5.1 in this dispute.   In addition, Canada asserts that the Panel was 
correct in finding that the issue of misuse and abus e was relevant "only to the extent that it [could]
                                                      
355Canada's appellee's submission, para. 56. 
356Ibid. 
357Ibid., para. 57. 
358Ibid., para. 87.  WT/DS321/AB/R 
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lead to an increased concentration of hormone residues in meat and meat products than would 
otherwise occur if good veterinary practices are applied."359  The Panel found in this regard that the 
European Communities had not evaluated the po tential for adverse effects arising from the 
consumption of meat containing residues of oestradiol-17 β as a result of cattle being treated with this 
hormone for growth-promotion purposes.  Thus, because the European Communities had not specifically assessed the risk arising from consumption of meat containing hormone residues, the 
Panel rightly found that whether the concen trations of residues of oestradiol-17 β in meat could be 
higher as a result of misuse and abuse did not need to be addressed.  Canada rejects the European 
Communities' argument that the Panel placed undue emphasis on the Codex standards, which assume good veterinary practices.  Canada submits that the Panel did not perceive its task as evaluating the 
SCVPH Opinions against the assessments by JECF A;  rather, once it had found that the European 
Communities had taken Codex into account, thereby co mplying with the terms of Article 5.1 of the 
SPS Agreement , the Panel was correct in using Codex's approach to risk assessment as a general 
reference.   
169. Canada contends moreover that  the Panel did not exclude  a priori  from its analysis evidence 
on possible misuse and abuse in the administration of  hormones, which was the legal error identified 
by the Appellate Body in EC – Hormones .  Rather, the Panel "properly confined its inquiry to the 
assessment that was material to the context of this case".
360  Canada submits that the Panel properly 
rejected the European Communities' attempt to  interpret the Appellate Body's finding in EC – 
Hormones —that risk assessments may include matters not susceptible of quantitative analysis—as 
allowing "risk management" considerations to be ta ken into account in a "risk assessment" within the 
meaning of Article 5.1.361  According to Canada, the European  Communities' arguments relating to 
"risk management" seek "to distract from the main  weakness of its case:  that it did not assess the 
specific risk".362 
170. Canada asserts that the Panel correctly held that the European Comm unities' risk assessment 
was not sufficiently specific to the particular risk at issue, that is, the adverse effects to human health 
arising from consumption of meat from  cattle treated with oestradiol-17 β for growth-promotion 
purposes.  Canada draws attention to  the Appellate Body's findings in EC – Hormones that the 
scientific evidence considered in a risk assessment must be "sufficiently specific"363 to the substance 
                                                      
359Canada's appellee's submission, para. 88 (referring to Panel Report, Canada – Continued 
Suspension , para. 6.154). 
360Ibid. 
361Ibid., para. 93 (referring to Panel Report, Canada – Continued Suspension , paras. 7.491 and 7.492). 
362Ibid., para. 93. 
363Ibid., para. 97 (quoting Appellate Body Report, EC – Hormones , para. 200).  WT/DS321/AB/R 
Page 68  
 
at issue in order for it to "sufficiently warrant" or "reasonably support" the SPS measure.
364  Canada 
maintains that the European Communities w as not absolved from conducting a quantitative 
assessment of such risk simply because the SCVPH Opinions indicate that oestradiol-17 β is 
genotoxic.  This is because the evidence referred to in the SCVPH Opinions relates to the genotoxicity 
of oestradiol-17 β  in vitro365, which does not indicate that it is genotoxic  in vivo .366  Canada rejects 
the European Communities' allegation that the Pa nel ignored Dr. Guttenplan's statement that the 
scientific evidence was specific in rela tion to the relevant risk.  This statement must be interpreted as 
referring only to the "hazard identification"367 phase of a risk assessment, and Dr. Guttenplan 
subsequently stated that "the evidence evalua ting the occurrence of adverse effects is weak."368  
Canada also notes that two other experts indicated very clearly that the European Communities "did 
not have scientific evidence to suppor t the assertion of the specific risk".369  Therefore, the Panel had a 
"solid basis"370 for finding that the risk assessments were not  sufficiently specific to the relevant risk 
arising from hormone residues in meat.   
171. Canada also contests the European Communities' assertion that the Panel erred in requiring a 
quantification of risks.  Canada observes th at, although the Appellate Body recognized in EC – 
Hormones that a risk assessment could be performed eith er quantitatively or qualitatively, it also held 
that a risk assessment is a pro cess "characterized by systematic, disciplined and objective enquiry and 
analysis".371  Therefore, a qualitative risk assessment must be "done in a scientifically rigorous 
fashion"372, and the European Communities could not ma ke a qualitative assessment on the basis of 
unproven assumptions where the available quantita tive data go against those assumptions.  The 
European Communities' risk assessment did not meet  this standard, because it did not contain either 
quantitative or qualitative evidence of the genotoxic potential of oestradiol-17 β  in vivo .  In addition, 
the European Communities failed to substantiate its  assertion that no threshold could be identified for 
                                                      
364Canada's appellee's submission, para. 98 (quoting Appellate Body Report, EC – Hormones , 
para. 193). (underlining omitted) 
365In vitro  means outside of the body, usually in a cell-based system in a test tube or culture dish..  
(Panel Report, US – Continued Suspension , footnote 509 to para. 7.393(d);  and Panel Report, Canada – 
Continued Suspension , footnote 500 to para. 7.390(d) (referring to transcript of the Panel meeting with the 
scientific experts, Panel Reports, Annex G, para. 96)) 
366In vivo  means in the whole organism, the intact organism (Panel Report, US – Continued 
Suspension , footnote 585 to para. 7.472 (referring to transcript of the Panel meeting with the scientific experts, 
Panel Reports, Annex G, para. 96)) 
367Canada's appellee's submission, para. 99.  
368Ibid. (quoting Panel Report, Canada – Continued Suspension , para. 7.495).  
369Ibid. (referring to replies to questions posed by the Panel to the scientific experts, Panel Reports, 
Annex D, paras. 129-144).   
370Ibid., para. 99.  
371Ibid., para. 101 (quoting Appellate Body Report, EC – Hormones , para. 187).   
372Ibid., para. 102.    WT/DS321/AB/R 
 Page 69 
 
 
oestradiol-17 β, because it did not provide evidence suggesti ng that this hormone is a "direct-acting 
genotoxicant".373   
172. Canada submits furthermore that the Pane l's examination of whether the European 
Communities had evaluated the "poten tial occurrence of adverse effects"374 does not express a 
preference for a quantitative analysis of  risk and is consistent with the  SPS Agreement .  This is 
because the only possible way to ex amine the "potential" for adverse effects, within the meaning of 
Annex A, paragraph 4, to the  SPS Agreement , is to "ask whether those adverse effects could ever 
occur ".375  Canada also points out that the Panel recogni zed that "potential" is a lesser threshold than 
"likelihood".376  Canada adds that the Panel's approach is consistent with the Appellate Body's finding 
in  EC – Hormones , because the Appellate Body did not fault th e panel in that dispute for finding that 
a risk assessment under Annex A, paragraph 4, re quires an evaluation of "the potential ... of 
occurrence of such effects".377  Canada additionally recalls th e Appellate Body's reasoning that 
Article 5.1 is "intended as a countervailing factor in respect of the right of Members to set their 
appropriate level of protection"378 pursuant to Article 3.3 of the  SPS Agreement .  By contrast, the 
European Communities seems to be arguing for an "unqualified right to defi ne its own level of 
protection"379 by asserting that the Panel erred in favour ing quantitative methods over qualitative ones 
when examining the risk assessment pe rformed by the European Communities. 
173. Canada asserts that the Panel made an objective assessment of the matter in reaching its 
finding that the European Communities' permanent ban on oestradiol-17 β was not based on a risk 
assessment within the meanin g of Article 5.1.  As the trier of facts, the Panel was entitled to accord 
more weight to the views of those experts it found to  be credible and persuasive.  Canada emphasizes 
that, under the Appellate Body's interpretation, an objective assessment under Article 11 of the DSU 
implies, among other things, that a "panel must consider all the evidence presented to it, assess its 
credibility, determine its weight, and ensure that its factual findings have a proper basis in that 
evidence."380  Within these parameters, "panels enjoy discretion as the trier of facts, including in 
disputes involving the evaluation of scientific evidence"381 and, in the exercise of this discretion, are
                                                      
373Canada's appellee's submission, para. 106.  
374Ibid., para. 107 (referring to European Communities' appellant's submission, para. 340, in turn 
quoting Panel Report, US – Continued Suspension , para. 7.521, and Panel Report, Canada – Continued 
Suspension , para. 7.493). (emphasis omitted) 
375Ibid., para. 107. (original underlining) 
376Ibid., para. 108 (referring to Panel Report, Canada – Continued Suspension , para. 7.481). 
377Ibid. (referring to Appellate Body Report, EC – Hormones , para. 183). (emphasis omitted) 
378Ibid., para. 109 (referring to Appellate Body Report, EC – Hormones , para. 177).   
379Ibid., para. 109.  
380Ibid., para. 61 (quoting Appellate Body Report, Brazil – Retreaded Tyres , para. 185).  
381Ibid., para. 62 (referring to Appellate Body Report, Japan – Apples , paras. 166 and 221).   WT/DS321/AB/R 
Page 70  
 
entitled "to determine that certain elements of evid ence should be accorded more weight than other 
elements".
382  Thus, "[r]equiring panels, in their assessm ent of the evidence before them, to give 
precedence to the importing Member's evaluation of scientific evidence and risk is not compatible 
with this well-established principle."383  Canada underscores that, give n the discretion afforded to 
panels to appreciate the value of the evidence before them, the Appe llate Body has made clear that 
"not every error in the appreciation of the evidence ... may be characterized as a failure to make an 
objective assessment of the facts."384 
174. Canada maintains that the European Communiti es has failed to demonstrate that the Panel 
exceeded the bounds of its discretion as the trier of facts in reaching its factual findings regarding the 
consistency with the  SPS Agreement   of the permanent ban on meat from cattle treated with 
oestradiol-17 β imposed pursuant to Directive 2003/74/EC .  Canada does not view the Panel's 
statement that it was in a situation "similar"385 to that of a risk assessor as an indication that the Panel 
"drifted into a  de novo  review"386 of the European Communities' ri sk assessment.  Rather, the Panel 
made use of the advice given by the experts as context to assess the alleged compliance of the 
European Communities' measure with the r ecommendations and rulings of the DSB in EC – 
Hormones .  In this regard, the Panel specifically acknow ledged that it was poorly suited to engage in a 
de novo  review of the European Communities' risk assessment.387  According to Canada, as the trier 
of facts, the Panel was entitled to give greater weig ht to the advice of certain experts, and was under 
no obligation to treat all advice received from the experts "on an equal footing".388  Thus, rather than 
"picking and choosing"389 between the opinions of the experts, the Panel weighed the advice received 
from the different experts and carried out an obj ective assessment of the matter before it, in 
conformity with Article 11 of the DSU.   
175. Turning to the specific allegations of e rror made by the European Communities under 
Article 11 of the DSU, Canada characterizes as "simply false"390 the European Communities' 
allegation that the Panel did not take into account evidence relate d to exposure to hormones from 
multiple sources.  The Panel "specifically acknowledge [d] that it had considered  the issue [of multiple 
                                                      
382Canada's appellee's submission, para. 62 (quoting Appellate Body Report, EC – Asbestos , para. 161).  
383Ibid. (quoting Appellate Body Report, Japan – Apples , para. 166). (emphasis omitted) 
384Ibid., para. 64 (quoting Appellate Body Report, EC – Hormones , para. 133). (emphasis omitted)  
Canada also refers to Appellate Body Report, Brazil – Retreaded Tyres , para. 186;  and Appellate Body Report, 
Chile – Price Band System (Article 21.5 – Argentina) , para. 240.  (Canada's appellee's submission, paras. 63 
and 67) 
385Ibid., para. 71 (quoting Panel Report, Canada – Continued Suspension , para. 7.409).  
386Ibid., para. 72 (quoting European Communities' appellant's submission, para. 237). 
387Ibid., para. 72 (referring to Panel Report, Canada – Continued Suspension , paras. 7.107, 7.405, 
7.406, 7.571, and 7.630).  
388Ibid., para. 73.  
389Ibid., para. 74 (quoting European Communities' appellant's submission, para. 239).  
390Ibid., para. 77.   WT/DS321/AB/R 
 Page 71 
 
 
exposure]"391 in its analysis of the European Communities'  risk assessment under Article 5.1, and for 
this reason did not fail to conduct an objec tive assessment as required by Article 11. 
176. Furthermore, Canada rejects the European Comm unities' contention that the Panel imposed an 
incorrect "specificity" or "direct causality" requirement.392  Rather than requiring the "demonstration 
of actual effects"393, the Panel correctly required the Eu ropean Communities "to evaluate the 
possibility that the identified adver se effect came into being, orig inated, or resulted from the presence 
of residues of oestradiol-17 β in meat or meat products as a result of the cattle being treated with the 
hormone for growth promoting purposes."394  According to Canada, this neither amounts to a 
requirement that the European Communities demonstrate "actual effects"395, nor is it a violation of 
Article 11 by the Panel.   
177. Finally, Canada maintains that the Pane l "extensively dealt"  with the evidence396 related to the 
genotoxicity of oestradiol-17 β in its report and concl uded that the scientific evidence referred to in the 
SCVPH Opinions did not "support the European Co mmunities' conclusion that for oestradiol-17 β 
genotoxicity had already been demonstrated explic itly", nor did it "support the conclusion that the 
presence of residues of oestradiol-17 β in meat and meat products as a result of the cattle being treated 
with the hormone for growth promotion purposes leads to increased cancer risk".397  Therefore, 
Canada asserts that the Panel carefully considered all the evidence before it on the genotoxicity of 
oestradiol-17 β, and did not fail to conduct an objective assessment of the matter as required by 
Article 11 of the DSU. 
178. Canada concludes that the Panel correctly interpreted and applied Article 5.1 of the 
SPS Agreement  and did not fail to make an objective assess ment of the matter under Article 11 of the 
DSU.  Canada therefore requests the Appellate Body to dismiss the appeal of the European 
Communities regarding the Panel's fi ndings under Article 5.1 of the  SPS Agreement .  
8. Article 5.7 of the  SPS Agreement  
179. Canada argues that the Panel properly found that  the relevant scientific evidence on the five 
hormones subject to the provisional ban was not "insufficient" within the meaning of Article 5.7 of 
                                                      
391Canada's appellee's submission, para. 77 (referring to Panel Report, Canada – Continued 
Suspension , para. 7.501).  
392Ibid., para. 79 (referring to European Communities' appellant's submission, paras. 259-270).  
393Ibid. (referring to European Communities' appellant's submission, para. 261). 
394Ibid., para. 80 (quoting Panel Report, Canada – Continued Suspension , para. 7.485). (underlining 
omitted) 
395Ibid. (quoting European Communities' appellant's submission, para. 261).  
396Ibid., para. 81.   
397Ibid. (quoting Panel Report, Canada – Continued Suspension , para. 7.540). (underlining omitted) WT/DS321/AB/R 
Page 72  
 
the  SPS Agreement .  Canada requests the Appellate Body to dismiss this ground of the European 
Communities' appeal.  
180. Canada submits that the Panel correctly consider ed the relevance of international standards in 
determining that the scientific evidence on risks pos ed by the five hormones was not "insufficient" 
within the meaning of Article 5.7.  Canada observes that the Panel did not find that the existence of 
international standards created an irrebuttable presu mption of the sufficiency of scientific evidence 
and amounted to a "legal bar"
398 to the adoption of provisional measures under Article 5.7.  Rather, 
the Panel was "expressing a presumption, not a conclusion"399, when it found that the existence of 
international standards "implies" that sufficient evid ence existed to complete a risk assessment.  This 
is borne out by the Panel's recognition that previ ously sufficient evidence could subsequently become 
"insufficient" within the meaning of Article 5.7 when it is "unsettled"400 by new studies.  Therefore, 
contrary to the European Communities' contention, the Panel explicitly recognized that, despite the 
existence of international standards, there could be situations where relevant scientific evidence 
becomes insufficient to conduct an adequate risk as sessment.  On that basis, the Panel went on to 
assess whether the "insufficiencies" identified by  the European Communities were enough to render 
insufficient the previously sufficient eviden ce upon which the JECFA ass essments were based. 
181. In addition, Canada suggests that the Panel corre ctly excluded from the scope of its analysis 
under Article 5.7 the level of prot ection chosen by the European Co mmunities.  The Panel was correct 
in finding that the ability of th e European Communities to conduct a risk assessment on four of the 
provisionally banned hormones could not "hinge on"401 its decision to apply a higher level of 
protection than that reflected in the internationa l standards.  The European Communities' argument 
that the "sufficiency" of scientific evidence under Ar ticle 5.7 depends on the acceptable level of risk 
adopted by a Member402 undermines the "basic logic" of the SPS Agreement , according to which 
Article 5.7 operates as a "temporary 'safety valve'"403 in situations where there is insufficient scientific 
evidence to allow a Member to c onduct a risk assessment that fulfils the requirements of Articles 2.2 
and 5.1.  The European Communities' approach w ould allow Members "to effectively exclude from 
the available pool of relevant scientific evidence,  any evidence that does not support their chosen 
level of protection"404 for purposes of evaluating whether ther e is sufficient scientific evidence to 
conduct a risk assessment.  Canada argues that a Memb er's desired level of protection is not relevant 
                                                      
398Canada's appellee's submission, para. 117.  
399Ibid., para. 118. (underlining omitted) 
400Ibid., para. 119 (referring to Panel Report, Canada – Continued Suspension , para. 7.598).  
401Ibid., para. 122.  
402Ibid., para. 121 (referring to European Communities'  appellant's submission, para. 397;  and Panel 
Report, Canada – Continued Suspension , paras. 7.618 and 7.619). 
403Ibid., para. 122.  
404Ibid., para. 123.   WT/DS321/AB/R 
 Page 73 
 
 
for determining whether the scientific evidence is "i nsufficient" within the meaning of Article 5.7, 
because the "autonomous right"405 of WTO Members to introduce measures that result in a higher 
level of protection than the one achieved by measures based on international standards under 
Article 3.3 is subject to the requirement that such measures be based on a risk assessment.   
182. Canada maintains that the Panel did not err in allocating to the European Communities the 
burden of proving the insufficiency of the scientific evidence under Article 5.7.  Canada considers that 
the Panel correctly characterized Article 5.7 as a "qualified exemption"406 from the obligation under 
Article 2.2 not to maintain SPS meas ures without sufficient scientific evidence.  Article 5.7 is not an 
option that can be freely chosen by a Member.  Rather, it operates as a "temporary 'safety valve'"407 in 
situations where some evidence exists but are not enough to complete a full  risk assessment.  The 
Panel shifted the burden of proof under Article 5.7 to the European Communities only once it was 
satisfied that Canada had sufficiently refuted th e European Communities' allegation of compliance 
through positive evidence of a breach of Article 5.7.  Canada posits further that  this allocation of the 
burden of proof is consistent with  the Appellate Body's ruling in US – Wool Shirts and Blouses , 
because it was for the European Co mmunities, as the party alleging a breach of Article 22.8 of the 
DSU, to demonstrate that its implementing measure complied with Article 5.7 of the  SPS 
Agreement .408 
183. Furthermore, Canada argues that the Panel did not err in finding that, in situations where 
international risk assessments have been conducted for the substances at issue, a "critical mass" of 
new evidence would be required to render the rele vant scientific evidence "insufficient" for the 
purposes of Article 5.7.  Canada dismisses the Eur opean Communities' argument that the "critical 
mass" standard excludes  a priori  the possibility that a WTO Member  base its risk assessment on 
respectable minority views.  Canada recalls the A ppellate Body's finding that a measure conforming 
to the requirements of Article 5.1 may be based on minority opinions.409  In these situations, Canada 
argues, there is "inherently"410 sufficient evidence to perform a ri sk assessment that provides a basis 
for the SPS measure.  Article 5.7, in contrast, only a pplies to situations where there is "insufficient" 
scientific evidence to conduct a risk assessment "at a ll", regardless of whether a measure is based on 
                                                      
405Canada's appellee's submission, para. 124 (quoting Appellate Body Report, EC – Hormones , 
para. 172).  
406Ibid., para. 114 (quoting Appellate Body Report, Japan – Agricultural Products II , para. 80. 
(emphasis omitted))   
407Ibid., para. 122. 
408Ibid., para. 115 (referring to Appellate Body Report, US – Wool Shirts and Blouses , p. 14, DSR 
1997:I, 323, at 335).   
409Ibid., para. 127 (referring to Appellate Body Report, EC – Hormones , para. 194;  and Appellate 
Body Report, EC – Asbestos , para. 178). 
410Ibid., para. 127.  WT/DS321/AB/R 
Page 74  
 
"minority" or "mainstream" scientific opinions.
411  Therefore, contrary to  the European Communities' 
contention, "the concept of critical mass as applie d by the Panel cannot be assimilated with the 
findings of the Appellate Body on the validity of basing an SPS measure on minority views."412  
Canada adds that the notion of "critical mass" used  by the Panel does not specify how much evidence 
would be needed to make insufficient scientific ev idence that was previously  sufficient, nor does it 
exclude the possibility that one "new study or seri es of studies could call into question the scientific 
assumptions underpinning the current understanding of a scientific issue."413  Thus, Canada submits, 
the Panel's "critical mass" standard  "correctly sets a high threshold"414 reflecting the presumption in 
this dispute that the available scien tific evidence had been sufficient to adopt the relevant international 
standards. 
184. Finally, Canada argues that the Panel did not  fail to conduct an objective assessment of the 
facts under Article 11 of the DSU in reachi ng its findings under Article 5.7 of the  SPS Agreement .  
Canada asserts that the European  Communities' allegation that the Panel acted inconsistently with 
Article 11 appears to have "lost sight of the process that the Panel was engaged in"415, which was to 
arrive at an objective determination of the facts in  accordance with Article 11 of the DSU.  Canada 
refers to its earlier arguments that, as the trier of facts, the Panel had the discretion to determine what 
weight to attach to the statements made by the e xperts in the course of the proceedings, and to assess 
the experts' expertise and credibility.416  Canada rejects the European  Communities' allegations that 
the Panel "systematically downplay[ed]"417 the expert opinions indicating that the scientific evidence 
was insufficient to carry out a risk assessment.  According to Canada, su ch allegations fail to take into 
account the fact that, in addition to reviewing th e written answers by the experts to the Panel's 
questions, the Panel was able to "observe these expe rts" during the meetings with them and was able 
to "arrive at an assessment of their respective expertise and thei r credibility in particular areas".418  
Thus, it was on this basis that the Panel was en titled to rely more on the views expressed by some 
experts than those of others.  Therefore, the Pa nel's reliance on the views of these experts was fully 
consistent with its function as the trier of facts, a nd thus was consistent with Article 11 of the DSU. 
185. Canada concludes that the Panel correctly in terpreted and applied Article 5.7 of the  SPS 
Agreement  and did not fail to make an objective assessment of the matter under Article 11 of the 
                                                      
411Canada's appellee's submission, para. 127.  
412Ibid., para. 128. 
413Ibid. 
414Ibid. 
415Ibid., para. 129. 
416See also supra , paras. 173 and 174. 
417Canada's appellee's submission, para. 130 (quoting European Communities' appellant's submission, 
para. 427, and referring to para. 429). 
418Ibid., para. 130.  WT/DS321/AB/R 
 Page 75 
 
 
DSU.  Canada therefore requests the Appellate Body to dismiss the appeal of the European 
Communities regarding the Panel's fi ndings under Article 5.7 of the  SPS Agreement .  
D. Claims of the United States – Other Appellant  
186. The United States claims that the Panel erre d in finding that the United States has acted 
inconsistently with Articles 23.1 and 23.2(a) of th e DSU by "seeking the redress" of a violation in 
relation to Directive 2003/74/EC and by making a dete rmination of violation without recourse to the 
rules and procedures of the DSU.  The United Stat es requests the Appellate Body to reverse these 
findings of the Panel.   
1. Alleged Discrepancies in the Panel's De scription of the Measure at Issue  
187. The United States submits that conceptual difficu lties and apparent discrepancies exist in the 
Panel's description of the measure at issue and in the Panel's identification of the relevant timeframes 
associated with the suspension of concessions.  Th e Panel described the measure at issue as the 
"suspension of concessions ... con tinued without recourse to the procedures under the DSU", or the 
"continued application by the United States ... of its  decision to apply ... import duties in excess of 
bound rates ... without recourse to the procedures under the DSU."419  These descriptions are not only 
different, but confuse the legal claims made by the European Communities w ith what should be a 
factual description of the measure.  The relevant  timeframe of the measure was identified as from the 
"adoption of Directive 2003/74/EC", or "after the notification to the DSB of Directive 2003/74/EC".
420  Such discrepancies, in the United States' view, reflect a conceptual 
difficulty with the Panel's approach  and show that the Panel appeared to be struggling to explain how 
it could find that the suspension of concessions author ized by the DSB is inconsistent with the United 
States' obligations under the WTO.  According to the United States, "the Panel appear[ed] to be trying 
to characterize the measure not as the duties them selves, but as something else, something that 
changed in the measure once the [European Co mmunities] notified its (inaccurate) claim of 
compliance"421;  nonetheless, there was no new measure as a result of the European Communities' 
claim of compliance and no modification or other alteration in the duties. 
                                                      
419United States' other appellant's submission, para. 21 (quoting Panel Report, US – Continued 
Suspension , paras. 2.7 and 7.151). 
420Ibid., para. 26 (quoting Panel Report, US – Continued Suspension , paras. 2.7 and 7.151). (emphasis 
omitted) 
421Ibid., para. 27. WT/DS321/AB/R 
Page 76  
 
2. The Panel's Findings under Article 23.1 of the DSU
 
188. The United States argues that the Panel "simply err[ed]" when it found that the application of 
the suspension of concessions was "without recourse to the procedures under the DSU".422  T h e  
United States observes that, before it was author ized by the DSB to suspend concessions, it had 
extensive and lengthy recourse to multiple proce dures under the DSU and "had fully complied with 
all relevant rules and procedur es of the DSU ... in bringing the EC – Hormones  dispute, determining 
the applicable [reasonable period of time] for co mpliance, determining the appropriate level of 
suspension of concessions, and obtaining the aut horization of the DSB to suspend concessions".423  
The United States emphasizes that the DSB's aut horization to suspend concessions, which it was 
granted on 26 July 1999, "has never been revoke d and the [United States'] application of duties 
pursuant to that authorization has continued, unchanged", to this day.424   
189. The United States asserts that, by finding that the United States was seeking the redress of a 
violation in relation to Directive 2003/74/EC, the Panel "re-characteriz[ed]"425, without any legal 
basis, the United States' suspension of co ncessions as now being directed against 
Directive 2003/74/EC.  The United States furthe r submits that the European Communities' 
notification of Directive 2003/74/EC to the DSB was a mere unilateral declaration of compliance, and 
that such a declaration does not fulfil any of th e three conditions under Article 22.8 that must be 
satisfied before the DSB's authorization would cease to operate.  The United States explains, 
moreover, that the Panel seemed to have improperly inferred that there was "some deadline by which 
a Member must respond to such a unilateral declaration"426, when no such deadline was provided for 
in the DSU.  Therefore, the United States argues that the Panel erroneously  permitted the unilateral 
declaration of compliance to transform the lega l justification for the suspension of concessions 
maintained by the United States.  Given that the Pa nel found that the inconsistent measure has in fact 
not been removed, the multilateral DSB aut horization remains in place and effective. 
190. In the United States' view, the Panel's re-char acterization of the legal justification for the 
suspension of concessions, as now directed agai nst Directive 2003/74/EC, is "fatally flawed"427 for 
several reasons.  First, the Panel's finding is inco nsistent with the ordinary meaning of the term 
"authorized", which is defined as "legally  or formally sanctioned or appointed"428, and with the fact 
                                                      
422United States' other appellant's submission, para. 29. 
423Ibid., para. 17. 
424Ibid., para. 18. 
425Ibid., para. 31. 
426Ibid., para. 37. 
427Ibid., para. 40. 
428Ibid., para. 43 (quoting The New Shorter Oxford English Dictionary , 4th edn, L. Brown (ed.) 
(Clarendon Press, 1993), Vol. 1, p. 151).  WT/DS321/AB/R 
 Page 77 
 
 
that an "authorized" act is by defin ition consistent with the law.  Ther efore, the Panel's finding that the 
United States' suspension of concessions, which rema ins authorized, could constitute a violation of 
Article 23.1 was based on the paradoxical propos ition that an act permitted by the law can 
simultaneously be prohibited by the law.  Seco ndly, the Panel's analysis relied on a "false 
dichotomy"429:  where a measure taken to comply is notified, a complaining party either terminates the 
suspension of concessions because it  concludes that the measure is consistent with the covered 
agreements, or continues the suspension of concessi ons because it considers that the measure does not 
bring the implementing Member into compliance.  In the United States' view, such a false dichotomy lacks a basis in the DSU because th e DSU does not require a Member to form definitive conclusions 
regarding the validity of a unilateral declaration of  compliance.  The United States simply kept the 
duties in place and maintained the  status quo  on the basis that the European Communities' 
declaration of compliance has not been multilaterally confirmed. 
191. In addition, the United States asserts that the Panel erred in the allo cation of the burden of 
proof as it relieved the European Communities of the duty to make a  prima facie  case of 
inconsistency under Article 23.1 of the DSU.  Furthe rmore, the United States recalls that, in rejecting 
the United States' argument that the European Co mmunities has failed to show that the conditions 
under Article 22.8 for terminating the suspension of  concessions have been met, the Panel reasoned 
that it is the obligation of the Member suspending co ncessions to ensure that the suspension is applied 
only until such time as foreseen in Article 22.8.  Th e United States contends that Article 22.8 does not 
assign such responsibility to the Member suspending  concessions and does not specify the procedures 
for determining whether the conditions in Article 22 .8 are met.  To the United States, "[w]hat is 
clear"
430 under Article 22.8 is that there is no basis to  find that a multilateral authorization to suspend 
concessions is to be terminated by a unilateral declaration of compliance.  A responding Member 
should not be able to escape the suspension of con cessions and force the complaining party to engage 
in dispute settlement "simply by notifying a claim of compliance".431 
192. The United States submits that the Panel's findi ngs under Article 23.1 lead to "fundamentally 
problematic"432 consequences, because, simply by clai ming compliance, a Member could escape the 
application of the suspension of concessions and force the complaining party to initiate another 
dispute settlement proceeding, potentially creating an "endless loop"433 of litigation.  The United 
States additionally submits that the Panel "effectiv ely read[s] into [Article 22.8 of the DSU] an 
obligation" on the Member suspending concessions  "to take steps by some deadline to ascertain 
                                                      
429United States' other appellant's submission, para. 45. 
430Ibid., para. 57. 
431Ibid., para. 62. 
432Ibid., para. 60. 
433Ibid., para. 65. WT/DS321/AB/R 
Page 78  
 
whether the conditions in Article 22.8 have been met".
434  Consequently, the Panel's approach "would 
add to the rights and obligations of Members in contravention of"435 Article 19.2 of the DSU.  The 
United States asserts that the DSU does not specify th e rules applicable to the situation in the post-
suspension stage where an original responding party has declared itself to be in compliance four years 
after the reasonable period of time for implementati on has expired.  Thus, pa nels and the Appellate 
Body "should not supplant the work and efforts of Members to provide clarifications or improvements 
to the DSU".436  The United States observes that the DSU " does not leave parties in a post-suspension 
state of play bereft of tools to obtain redress and resolution"437, and recourse to a normal panel 
proceeding remains an option to Members in the pos t-retaliation stage, as the European Communities 
chose to do in this dispute.  
3. The Panel's Findings under Article 23.2(a) of the DSU  
193. The United States also takes issue with the Pane l's finding that the statements made by the 
United States at the DSB meetings constituted a un ilateral "determination" to the effect that a 
violation occurred within the meaning of Article 23. 2(a) of the DSU.  This conclusion, according to 
the United States, was neither consistent with the or dinary meaning of the term "determination" in its 
context and in the light of the object and purpose of  the DSU, nor supported by the negotiating history 
of the DSU.  According to its ordinary meaning, a "determination" is a "final and definitive" decision 
that results from some kind of deliberative process and leads to a significant consequence.438  T h e  
United States finds contextual support for this inte rpretation in the final clause of Article 23.2(a), 
which requires that determinations  be consistent with the recommendations and rulings of the DSB, 
and thus confirms that a determination must be fi nal and definitive.  The United States argues that its 
statements made at the DSB meetings did not cons titute a "determination", because these statements 
did not embody any definitiveness or finality and were , instead, punctuated with equivocation.  Due to 
the complexity of making any good faith attempt to  examine the European Communities' claim that 
Directive 2003/74/EC is consistent with the  SPS Agreement , the United States needed time for review 
and could not be expected to have  made a determination within a mere few weeks of the notification 
of Directive 2003/74/EC by the European Commun ities.  Turning to the negotiating history of 
Article 23.2(a), the United States maintains that the "determination" that the negotiators intended to 
target under Article 23.2(a) was of the type and na ture of the unilateral de terminations made under 
                                                      
434United States' other appellant's submission, para. 66. 
435Ibid. 
436Ibid., para. 69. 
437Ibid., para. 70. 
438Ibid., paras. 74-78.  WT/DS321/AB/R 
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Section 301 of the United States Trade Act of 1974439, which were made at the conclusion of formal 
investigations and which resulte d in certain legal consequences.440  In addition, the United States 
contends that subjecting Members' DSB statements, which "are generally diplomatic or political in 
nature and prepared ... independe ntly of any ... deliberative pro ceedings", to the discipline of 
Article 23.2(a) "will undoubtedly result in a 'chilling' effect on those statements".441 
194. Furthermore, the United States alleges that a "determination" within the meaning of 
Article 23.2(a) cannot be inferred or implied, and the Panel erred in making such an inference from 
the United States' "inaction" regarding the suspension of concessions.442  The United States adds that 
the Panel's inference "effectively reads into Artic le 23 a deadline by which a determination will be 
imputed to a Member"443, even though Article 23 contains no such deadline and the Panel itself 
struggled to identify the proper timeframe after which the "continuation of suspension" would be 
considered to be inconsistent with Article 23.  Fo r the United States, "[t]he Panel's findings appear[ed] 
to require complaining parties and other Members to be  silent in the face of a claim of compliance or 
risk having any reaction other than agreemen t be construed to be a 'determination'."444  The United 
States additionally observes that, "even if the reac tion is not sufficient to be a 'determination', it 
appears that a Member would risk such a reaction ri pening into a 'determination' based simply on the 
passing of an unspecified deadline, whic h the Panel acknowledged does not exist."445 
4. The Scope of the Panel's Manda te and the Panel's Suggestion  
195. In the event the Appellate Body upholds the Panel's findings under Articles 23.2(a) and 23.1, 
the United States requests the Appellate Body to reverse the Panel's "erroneous suggestion"446 that the 
United States must bring itself into conformity by  having recourse to the rules and procedures of the 
DSU without delay.  The United States contends th at the Panel engaged in a detailed review of 
Directive 2003/74/EC and its consistency with both  the DSB's recommendations  and rulings and the 
SPS Agreement .  Thus, recourse to the rules and procedur es of the DSU has already been achieved, 
because "a fair and objective reading of the language in Articles 23.1 and 23.2(a) does not exclude instances"
447 in which a Member may "have recourse" by participating in a dispute settlement 
proceeding initiated by another WTO Member, as the United States did in this dispute.  The United 
                                                      
439United States Trade Act of 1974, Public Law No. 93-618, 88 Stat. 1978 (1975), United States Code , 
Title 19, section 2101. 
440United States' other appellant's submission, para. 88. 
441Ibid., paras. 93 and 95. 
442Ibid., paras. 98-104. 
443Ibid., para. 105. 
444Ibid., para. 106. 
445Ibid., para. 106. 
446Ibid., para. 108. 
447Ibid., para. 111. WT/DS321/AB/R 
Page 80  
 
States observes that requiring re-litigation of the matters that have already been "reviewed and 
considered"
448 in these proceedings would not be an e fficient use of the WTO dispute settlement 
system, and would be contrary to the objective of "prompt settlement" of disputes set out in 
Article 3.3 of the DSU.   
196. The United States further submits that the Panel erred in finding that it had no jurisdiction to 
rule on the compatibility of Directive 2003/74/EC with the  SPS Agreement .  The United States argues 
that the Panel improperly limited the scope of its mandate on the basis that the European 
Communities had articulated its cl aim under Article 22.8 as a conditiona l claim.  The United States 
asserts that "[a] panel's terms of reference, once de termined at the outset of the dispute, cannot be 
narrowed or otherwise modified by a complaining party."449  According to the United States, the 
relevant provision governing the term s of reference of a panel is Article 7 of the DSU, which "does 
not provide for a change to the terms of refere nce based on the complaining party's submissions".450  
Therefore, in the United States' view, this finding by the Panel should be re versed, and the Panel's 
findings regarding the WTO-inconsistency of Di rective 2003/74/EC, made in the context of 
addressing the European Communities' second series of  main claims, should be considered "direct" 
findings.451 
5. Conclusion  
197. In sum, the United States requests the Appellate Body to:  (i) reverse the Panel's findings that 
the United States has acted inconsistently with Articl es 23.1 and 23.2(a) of the DSU;  (ii) reverse the 
Panel's suggestion that the United States should have  recourse to the rules and procedures of the DSU 
without delay;  and (iii) reverse the Panel's conc lusion that it was not empowered to make a direct 
determination of the consistency of Directive 2003/74/EC with the   SPS Agreement .  The United 
States nevertheless clarifies that the Appellate Body need not reach the last two issues if it reverses 
the Panel's findings that the United States has acted inconsistently with Articles 23.1 and 23.2(a) of 
the DSU. 
E. Claims of Canada – Other Appellant  
198. Canada requests the Appellate Body to revers e the Panel's finding that Canada has acted 
inconsistently with Articles 23.1 and 23.2(a) of the DSU by maintaining the suspension of 
concessions after the notification of Directive 2003 /74/EC by the European Communities.  Canada
                                                      
448United States' other appellant's submission, para. 113. 
449Ibid., para. 117. 
450Ibid. 
451Ibid., para. 119.  WT/DS321/AB/R 
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submits that the Panel erred in addressing the Eu ropean Communities' claims of violation under 
Articles 23.1 and 23.2(a) completely separately from the requirements of Article 22.8 of the DSU.  
Even if the Panel did not err in examining Article  23 in isolation from Article 22.8, Canada argues 
that the Panel erred in finding that Canada h as breached Articles 23.1 and 23.2(a) by seeking the 
redress of a violation without recourse to the rules and procedures of the DSU.   
1. The Panel's Examination of Articles 23 .1 and 23.2(a) "In Isolation" from 
Article 22.8 of the DSU  
199. Canada alleges that the "fundamental legal error"452 of the Panel is its examination of the 
European Communities' claim under Articles 23.1 a nd 23.2(a) in isolation from its analysis under 
Article 22.8 of the DSU.  According to Canada, th e "[k]ey to this case is Article 22.8 of the DSU"453, 
which, as  lex specialis  applicable to the post-retaliation phase of a dispute, sets out the three 
conditions that must be met in order to have the suspension of concessions terminated, one of the 
conditions being actual compliance with the DSB's recommendations and rulings.  Canada maintains 
that the "continuous involvement of the DSB", pursuant to the second sentence of Article 22.8, 
"suggests that [the DSB] retains jurisdiction ove r the matter until its recommendations and rulings 
have been fully implemented".454  Canada explains that "[t]hi s is consistent with the ongoing 
obligation on the Member being re taliated against to comply with its WTO obligations, including the 
requirement to comply promptly with the recommendations and rulings of the DSB."455 
200. As regards Article 23, Canada submits that this provision begins by setting out general 
obligations that apply to what it refers to as the pre-dispute settlement stage of a dispute and then 
proceeds by setting out specific obligations ( lex specialis ) applicable through the compliance and 
retaliation stages of dispute settlement proceedings.  Whereas the examples of prohibited unilateral 
conduct contained in Article 23.2 are not exhaustive, the structure of the Article indicates that, when a 
particular dispute has entered the compliance or retaliation stages, the relevant obligations are those in 
subparagraphs (b) a nd (c) of Article 23.2, a nd the general obligations contained in Articles 23.1 
and 23.2(a) are no longer pertinent.  Indeed, Ca nada observes, the only way for a complaining 
Member to have reached the compliance or retaliation stage is to have already satisfied those general 
obligations by having engaged in the WTO disput e settlement process and obtained a DSB ruling that 
the responding Member has violated its obliga tions.  Canada additionally notes that the travaux 
préparatoires  provide a further indication that the DSU negotiators did not contemplate that 
Article 23 would apply to a post-reta liation situation.  Canada thus argues that, in this case, since it 
                                                      
452Canada's other appellant's submission, para. 6. 
453Ibid., para. 35. 
454Ibid., para. 36. 
455Ibid. (footnote omitted) WT/DS321/AB/R 
Page 82  
 
has had recourse to the rules and procedures of the DSU in the EC – Hormones  dispute and is 
suspending concessions pursuant to a DSB authorizati on, Canada has already satisfied the obligations 
contained in Articles 23.1 and 23.2(a).  Therefore, as suggested by the text of Article 23.2(c), the 
Panel should have turned first to the provisions of  Article 22, including the specific requirements of 
Article 22.8 that apply to the question of whether the suspension of concessions should be terminated.  
By failing to do so, the Panel's approach resulted in "contradictory findings"
456 that, on the one hand, 
Canada has breached Articles 23.1 and 23.2(a) of  the DSU by continuing the suspension of 
concessions and, on the other hand, that Canada  has the right to continue the suspension of 
concessions pursuant to Article 22.8 because the Eu ropean Communities' inconsistent measure has 
not been removed. 
201. Canada asserts, moreover, that the Panel failed to consider the object a nd purpose of the DSU.  
By considering Article 23 in isolation from other pr ovisions of the DSU, the Panel arrived at findings 
that ultimately lessen the effectiven ess of the WTO dispute settlement mechanism.  The result is that 
"a non-compliant WTO Member could avoid the duly authorized suspension of concessions by another Member merely by adopting an alleged im plementing measure, notifying such measure to the 
DSB and waiting to be challenged."
457  In Canada's view, such a re sult has the effect of undermining 
DSB-authorized retaliation, thereby weakening an important incentive for Members to bring their 
measures promptly into compliance.  Canada conte nds that only a further multilateral determination 
of compliance by the DSB can set aside the DSB's prior authorization to suspend concessions.  In 
Canada's view, the European Communities has the bur den of initiating a panel proceeding—either an 
Article 21.5 proceeding or a  de novo  action against the suspension of concessions—to obtain such a 
multilateral determination. 
202. Canada further maintains that, in examini ng the European Communities' claims under 
Articles 23.1 and 23.2(a) of the DSU in isolation from its examination of Article 22.8, the Panel 
erroneously followed the order of analysis proposed  by the European Communities, even though such 
order of analysis is contrary to the principle of  lex specialis , according to which the specific terms of 
a treaty must prevail over the general provisions.458  The application of the  lex specialis  principle 
should have led the Panel to begin its analysis  by determining whether the conditions for the 
                                                      
456Canada's other appellant's submission, para. 43. 
457Ibid., para. 47. 
458Ibid., paras. 52-57.  Canada refers to the Appellate Body's statement in Canada – Wheat Exports and 
Grain Imports  that "panels are free to structure the order of thei r analysis as they see fit" but they "may find it 
useful to take account of the manner in which a claim is presented to them" by the complaining party;  however, 
Canada contends that "panels must be careful not to simply follow the order of analysis as pleaded by a complainant", which may itself contain errors of law, especially if th e relationship between two provisions 
mandates a certain sequence of analysis. ( Ibid., paras. 54 and 55 (quoting Appellate Body Report, Canada – 
Wheat Exports and Grain Imports , paras. 109 and 126))  WT/DS321/AB/R 
 Page 83 
 
 
termination of the suspension of concessions set out  in Article 22.8 have been met.  Canada  
criticizes the Panel for using "two different and in consistent manners of identifying the [European 
Communities'] implementing measure at issue".459  Canada explains that, while examining the second 
series of the European Communities' main claims, th e Panel gave a broad interpretation to the term 
"measure" in Article 22.8 of the DSU and recognized  that the phrase "until such time as the measure 
found to be inconsistent with a c overed agreement has been removed" means that the "illegality itself" 
and not only the originally impugned measure had been removed.  By contrast, in its approach to the 
first series of the European Communities' main clai ms, the Panel based its finding of a violation of 
Articles 23.1 and 23.2(a) of the DSU on the fact that the European Communities had notified a measure that had not yet been subject to dispute settlement.   
203. Canada also criticizes the Panel for ignoring the procedural history of the case.  According to 
Canada, Directive 2003/74/EC should be situated in  the post-retaliation context and should not be 
considered as "a new measure  ab initio ".
460  Given that Canada had obtained DSB authorization to 
suspend concessions, the onus should be placed on the European Communiti es to demonstrate its 
compliance to a WTO panel.  The Panel's findings that Canada has breached Articles 23.1 and 23.2(a) 
lead to a "manifestly absurd or unreasonable" interp retation that the mere adoption and notification of 
an alleged implementing measure by a WTO Member , which failed to bring itself into compliance 
within the reasonable period of time, could render the suspension of concessions authorized by the 
DSB inconsistent with the DSU.  Canada asser ts that the Panel's finding under Articles 23.1  
and 23.2(a) renders ineffective the substantive re quirements set out in Article 22.8 regarding the 
suspension of concessions, contrary to the prin ciple of effectiveness that should govern treaty 
interpretation.   
2. The Panel's Findings under Article 23.1 of the DSU  
204. Canada contends that, even if the Panel was correct in considering Articles 23.1 and 23.2(a) 
in isolation, the Panel erred in finding that Canada was "seeking the redress" of a WTO violation by continuing the suspension of concessions in respect of a measure that had not yet been subject to 
recourse to the DSU.  According to Canada, the Panel's finding ignored the fact that Canada had 
"sought and obtained"
461 DSB authorization to suspend concessi ons as a result of the inconsistencies 
found in EC – Hormones , and that Canada has taken no action to "seek the redress" of any alleged 
WTO-inconsistency of the European Communities' purported implementing measure.  Canada further 
asserts that simply because Directive 2003/74/EC is a new measure does not imply that the legal basis 
                                                      
459Canada's other appellant's submission, para. 63. 
460Ibid., para. 64. 
461Ibid., para. 80. WT/DS321/AB/R 
Page 84  
 
for Canada's continued suspension of concessions ha s changed and that the suspension is now aimed 
at seeking the redress for any violations caused  by Directive 2003/74/EC.  Because Canada's 
suspension of concessions was authorized  by the DSB, it is "by definition"
462 WTO-consistent.  In 
Canada's view, "[t]he Panel e rred in imputing alleged WTO inconsistencies of the [European 
Communities'] purported implementing measure as the reasons for Canada's continued suspension of 
concessions in this case."463  Such an outcome would, in Canada's view, severely hinder the security 
and predictability of the WTO dispute settlement system, as Members would be unsure as to when, or 
for how long, they could prope rly rely on a DSB authorization to suspend concessions.   
3. The Panel's Findings under Article 23.2(a) of the DSU  
205. Furthermore, Canada alleges that the Panel e rred in finding that Canada made a unilateral 
determination that a violation occurred in relation to Directive 2003/74/EC, contrary to 
Article 23.2(a), on the basis of Canada's statements at the DSB meetings and its continued application 
of the suspension of concessions.  According to Cana da, there is an insufficient amount of "firmness 
or immutability" with respect to the statements made  by Canada at the DSB meetings for the Panel to 
conclude that Canada made "more or less a fina l decision" regarding the WTO-inconsistency of 
Directive 2003/74/EC.464  Canada also argues that, because it had obtained DSB authorization to 
suspend concessions, it did not see the need to take  a decision regarding the WTO-consistency of 
Directive 2003/74/EC, and that it was up to the European Communities to establish that it had 
implemented the DSB's recommendations and rulings in EC – Hormones .  Therefore, the Panel 
erroneously found that Canada's continuation of the suspension of concessions "corroborate[d]"465 the 
fact that Canada made a determination of viola tion in relation to Directive 2003/74/EC, because it is 
the DSB's authorization, rather than Canada's expression of views on the WTO-consistency of this 
Directive, that formed the basis of Ca nada's continued suspension of concessions. 
4. The Scope of the Panel's Manda te and the Panel's Suggestion  
206. Finally, should the Appellate Body uphold the Panel's finding that Canada has breached 
Articles 23.1 and 23.2(a) of the DSU, Canada re quests the Appellate Body to reverse the Panel's 
finding that it did not have jurisdiction to determ ine the compatibility of Directive 2003/74/EC with 
                                                      
462Canada's other appellant's submission, para. 84. 
463Ibid., para. 80.  Canada adds that the Panel's finding is flawed because it was not based on the notion 
of malfeasance ( ibid., para. 81 (referring to Panel Report, EC – Commercial Vessels , para. 7.188)) but, rather, 
was based on the notion of "non-feasance, whereby Canada's inaction, i.e., failure to terminate its suspension of 
concessions following the notification of [Directive 2003/74/EC] would be construed as 'seeking redress' of a 
violation pursuant to Article 23.1 of the DSU." ( Ibid., para. 81) 
464Ibid., paras. 87-89 (quoting Panel Report, US – Section 301 Trade Act , footnote 657 to para. 7.50;  
and referring to statements made at the DSB me etings held on 7 November and 1 December 2003). 
465Ibid., para. 91 (quoting Panel Report, Canada – Continued Suspension , para. 7.224).  WT/DS321/AB/R 
 Page 85 
 
 
the  SPS Agreement .  Canada explains that the Panel speci fically acknowledged that Article 22.8 of 
the DSU required it to consider, as a condition preced ent to finding a breach of this provision by 
Canada, the consistency of Di rective 2003/74/EC with the  SPS Agreement .  In addition, Canada 
considers that this finding contradicts the Pane l's finding that was made in the context of its 
examination of the European Communities' second seri es of main claims.  In that context, the Panel 
found that Canada has not breached Article 22. 8, because the European Communities has not 
removed the inconsistency found in EC – Hormones .   
207. Canada further requests the Appellate Body to  reverse the Panel's suggestion that Canada 
should have recourse to the rules and procedures of the DSU without delay.  Canada asserts that the 
Panel's suggestion ignores the fact that, earlier in its  report, the Panel conducted an extensive review 
of the compatibility of the European Co mmunities' implementing measure with the SPS Agreement .  
Nor does such recommendation contribute to a "pro mpt settlement" of the dispute as required by 
Article 3.3 of the DSU, because it would require a new panel proceeding to look at an issue that is already being dealt with in the c ontext of the current proceedings.  Finally, in Canada's view, this 
suggestion is contradictory to the Panel's findings  under Article 22.8, and its statement that it was 
performing a function similar to that of an Article 21. 5 panel.  The suggestion is  also inconsistent with 
Article 19.2 of the DSU, because it diminishes Canada 's right to suspend concessions pursuant to the 
authorization given by the DSB. 
5. Conclusion
 
208. In sum, Canada requests the Appellate Bo dy to reverse the Panel's findings under 
Articles 23.1 and 23.2(a) of the DSU that Canada wa s "seeking the redress" of a violation and made a 
"determination" of violation with respect to Di rective 2003/74/EC.  Canada requests the Appellate 
Body to find, instead, that:  (i) Articles 23.1 and 23. 2(a) of the DSU do not apply to a situation where, 
following the adoption of an alleged implementing measure after the reasonable period of time has 
elapsed, a Member continues the suspension of concessi ons pursuant to the DSB's authorization;  (ii) 
Canada has not acted inconsistently with Ar ticles 23.1 and 23.2(a) because the European 
Communities failed to demonstrate that it brough t itself into compliance, in accordance with 
Article 22.8 of the DSU;  and (iii) the Panel erre d in finding that it was bound by the manner in which 
the European Communities presented its two main claims.  Should the Appellate Body uphold the 
Panel's findings under Articles 23.1 and 23.2(a) of th e DSU, Canada requests the Appellate Body to 
reverse the Panel's finding that it did not have jurisdiction to determine the compatibility of WT/DS321/AB/R 
Page 86  
 
Directive 2003/74/EC with the covered agreements, a nd to remove the suggestion that Canada should 
have recourse to the rules and procedures of the DSU without delay.
466 
F. Arguments of the European Communities – Appellee  
209. The European Communities submits that the Pane l correctly found that the United States and 
Canada have breached Articles 23.1 and 23.2(a) of the DSU by maintaining the suspension of 
concessions after the notification of Directive 2003/74/EC, and requests the Appellate Body to 
dismiss Canada's and the United States' other appeals "in their entirety".467   
210. The European Communities makes two preliminary arguments.  First, the European 
Communities observes that the United States a nd Canada do not appear to dispute that 
Directive 2003/74/EC is a "measure taken to comp ly with the recommendations and rulings" of the 
DSB in the EC – Hormones  dispute.  Secondly, the European Communities asserts that the United 
States and Canada "entirely ignore"468 the fact that the European Communities' first series of main 
claims included Article 21.5, but did not incl ude Article 22.8 of the DSU.  The European 
Communities adds that the error in the Panel's r easoning was to ignore Article 21.5, rather than 
Article 22.8, as the United States and Canada a llege, although this error does not undermine the 
correctness of the Panel's conclusions of  violation of Articles 23.2(a) and 23.1. 
1. The "Harmonious" Interpretation of Articles 21, 22, and 23 of the DSU in the 
Post-Suspension Stage of a Dispute  
211. The European Communities maintains th at the "general and fundamental"469 provisions of 
Article 23 of the DSU apply throughout the implementation stage of a dispute.  The European 
Communities rejects the distinction made  by Canada between "a new measure ab initio " and 
"a measure taken"470 to implement the DSB's recommendati ons and rulings, as well as Canada's 
assertion that Articles 23.1 and 23.2(a) apply only to a new measure.  The European Communities 
submits that such a distinction lacks a textual basis in the covered agre ements.  The European 
Communities recalls that Article XVI:4 of the  WTO Agreement  requires Members to ensure the 
conformity of their laws with their WTO obligations, and maintains that, in the light of this provision, 
the multilateral dispute settlement system "relie s on good faith compliance and the presumption of 
conformity of measures taken by WTO Members"471, which does not change in the post-retaliation
                                                      
466Canada's other appellant's submission, paras. 99-101. 
467European Communities' appellee's submission, para. 148. 
468Ibid., para. 29.  
469Ibid., para. 36. 
470Ibid., para. 39 (quoting Canada's other appellant's submission, para. 64). 
471Ibid., para. 40.  WT/DS321/AB/R 
 Page 87 
 
 
stage of a dispute.  Therefore, the European  Communities argues, where a Member has taken a 
measure to implement the DSB's recommendations  and rulings, the Member suspending the 
concessions bears the burden of proving the WTO- inconsistency of the implementing measure.472  
The general burden of proving that a measure is WTO- inconsistent cannot be reversed simply because 
the original complainant has taken retaliatory measures.  The European Communities additionally 
contends that Canada, by stating th at "Article 23.1 is concerned with measures in respect of which no 
WTO dispute settlement proceedings have taken place"473, effectively reduces the scope of application 
of Article 23.1 and makes it "essentially meaningless in the implementation stage".474 
212. The European Communities further submits that  the interpretation of Articles 21 and 22, 
referenced in Article 23.2(b) and (c), should no t change depending on the stage of the dispute 
settlement process, including when the dispute reac hes the post-suspension stage.  The European 
Communities asserts that the  lex specialis  applicable to its first series of main claims is Article 21.5, 
and not Article 22.8, as Canada argues.  Article 22.8 "was part of and context for"475 the European 
Communities' second series of main claims.  The European Communities emphasizes that Directive 2003/74/EC, as a measure taken to comply, must be presumed to be compliant with the 
covered agreements until shown ot herwise through an Article 21. 5 proceeding.  The European 
Communities maintains that a Member suspending concessions must ensure that the suspension 
"complies at all times with the condi tions laid down in Article 22.8".
476  On this basis, the European 
Communities argues that the adoption of a measure taken to comply triggers the following duties of 
the original complaining party:  (i) to cease the su spension of concessions;  (ii) to form a view on 
whether the measure found to be inconsistent has been removed;  and (iii) to have recourse to 
Article 21.5 proceedings if it considers that the meas ure taken to comply is not consistent with the 
covered agreements.  The European Communities considers that its understanding of Members' 
obligations in the post-suspension stage results from a "harmonious"477 interpretation of Articles 21, 
22, and 23 of the DSU that gives effect to ea ch of these provisions.  The European Communities 
emphasizes that the WTO dispute settlement syst em is based on adversarial procedures where a 
Member claims the inconsistency of a measure take n by another Member, and is not applicable to 
requests for an abstract confirmation of the consistency of a measure.  
213. The European Communities maintains that the object and purpose of the DSU, according to 
Articles 3.7 and 3.3, is to secure a positive solution to, and prompt settlement of, a dispute.  Thus, the 
                                                      
472European Communities' appellee's submission, para. 40. 
473Ibid., para. 43 (quoting Canada's other appellant's submission, para. 38).   
474Ibid., para. 43. 
475Ibid., para. 51. 
476Ibid., para. 62. 
477Ibid., para. 36. WT/DS321/AB/R 
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United States' and Canada's suggestion that they  can simply wait until the European Communities 
brings a dispute to prove the consistency of its implementing measure goes fundamentally against the 
object and purpose of the DSU.  The European  Communities emphasizes that, upon the adoption of a 
measure taken to comply, the Member suspending concessions is required to cease the application of 
the suspension while it fulfils its obligation to ha ve recourse to dispute settlement procedures under 
Article 21.5.  Such an interpreta tion is consistent with the functio n of the dispute settlement system, 
which is for adjudicating disputes and not for main taining retaliatory measures where a measure to 
comply is taken in good faith.  The European Communities disagrees with the United States' and 
Canada's argument that the European Communities'  interpretation would fail to give effect to 
Article 22.8 of the DSU.  It explains that, on th e contrary, where a good faith measure has been taken 
to comply, as the European Communities did in this  case by adopting Directive 2003/74/EC, there is 
no legitimate interest in continuing the suspensi on of concessions, because the suspension would have 
achieved its objective and the suspension "does nothing to induce compliance".
478  The European 
Communities additionally submits that allowing a Me mber to continue the suspension of concessions 
despite the adoption of a measure taken to comply  effectively allows that Member to "extort"479 more 
than what it is entitled to under the covered ag reements.  By maintaining the suspension of 
concessions, the United States and Canada "in truth"480 wish to see the European Communities 
remove the import ban imposed on meat treated with  hormones, even though removal of the ban is not 
required under the covered agreements  as long as the ban is based on a risk assessment consistent with 
the  SPS Agreement .  Finally, the European Communities submit s that its position is consistent with 
the approach taken in the Articles on Responsib ility of States for Internationally Wrongful Acts481 (the 
"Articles on State Responsibility"), which require  that countermeasures be suspended if the 
internationally wrongful act has ceased and the dis pute is pending before a tribunal that has the 
authority to make decisions binding upon the parties.482 
214. The European Communities sums up its position on the proper interpretation of 
Articles 21, 22, and 23 as follows.  The fact that the suspension of concessions was authorized, and 
subsequently also applied, does not change the pr oper interpretation and application of Articles 21 
and 23.  The original complaining Member rema ins under an obligation to have recourse to a 
compliance procedure under Article 21.5 if it disagrees with the existence or consistency of a measure 
                                                      
478European Communities' appellee's submission, para. 81. 
479Ibid., para. 83. 
480Ibid., para. 84. 
481Articles on Responsibility of States for Internationally Wrongful Acts, adopted by the International 
Law Commission at its fifty-third session (2001) (Exhibit EC-136 submitted by the European Communities to 
the Appellate Body), Article 52.3.  The text of the Articles are annexed to United Nations General Assembly 
Resolution, A/RES/56/83, 29 January 2002 (Exhibit EC-135 submitted by the European Communities to the 
Appellate Body). 
482See European Communities' appellee's submission, paras. 94-96.  WT/DS321/AB/R 
 Page 89 
 
 
taken to comply with a covered agreement.  If it fails to do so, and simply waits and continues to 
apply the suspension of concessions, it necessaril y is seeking redress and makes a unilateral 
determination that a violation has occurred in respect of the implementing measure within the 
meaning of Articles 23.2(a) and 23.1.  In such a situ ation, the continued application of the suspension 
of concessions is simultaneously,  first, evidence that the original co mplaining Member disagrees with 
the existence or consistency with a covered agreement of the measur e taken to comply while refusing 
to have recourse to a compliance procedure under Article 21.5 (thus, making a "determination" that 
the new measure is WTO-inconsistent);  and, secondly , a breach of Article 23.1, read together with 
Articles 22.8 and 3.7, because it seeks redress followi ng its unilateral determination that the measure 
found to be inconsistent with the cove red agreements has not been removed. 
2. The Panel's Findings under Article 23.1 of the DSU  
215. With respect to the Panel's finding that the Un ited States is seeking the redress of a violation 
within the meaning of Article 23.1, the European  Communities recalls the United States' contention 
that the Panel erroneously re-characterized the suspension of concessions as now directed against 
Directive 2003/74/EC.  The European Communities asser ts that this contention is without merit, 
because the United States could no longer maintain  its suspension of concessions once the European 
Communities had removed Directive 96/22/EC.  The Panel confirmed the removal of 
Directive 96/22/EC, and the United States has not app ealed this finding.  Additionally, the European 
Communities argues that "the United States ignores that there is a presumption of good faith compliance by WTO Members", and that the adopti on of an implementing measure in good faith 
"triggers" an obligation to remove the suspen sion of concessions and requires the complaining 
Member to initiate Article 21.5 proceedings in case there is disagreement as to the WTO-consistency 
of the new measure.
483  The European Communities observes, mo reover, that "even the United States 
acknowledged that it was maintaining its suspen sion of concessions against the new measure".484  The 
European Communities further submits that, contrary  to the United States' assertion, the Panel's 
finding does not lead to a paradoxical result that th e authorized suspension of concessions can be both 
consistent and inconsistent with the covered agreements at the sa me time.  Rather, the European 
Communities argues, the suspension of concessions was initially WTO-consistent, and subsequently 
became WTO-inconsistent in the light of the notif ication of Directive 2003/74/EC and the removal of 
the measure found to be WTO-inconsistent in EC – Hormones , namely, Directive 96/22/EC.  
Therefore, the continued application of sanctions  in the presence of a compliance measure that the 
DSB has not found to be WTO-inconsistent implies th at a Member is seeking to redress a violation.   
                                                      
483European Communities' appellee's submission, para. 104. (emphasis omitted) 
484Ibid., para. 106 (referring to Panel Report, US – Continued Suspension , paras. 7.219-7.221 and 
footnote 438 thereto). WT/DS321/AB/R 
Page 90  
 
216. Turning to the Panel's finding that Canada is  seeking the redress of a violation within the 
meaning of Article 23.1, the European Communitie s disagrees with Canada's argument that the 
notification of Directive 2003/74/EC does not change  the legal basis of Canada's suspension of 
concessions.  The European Communities submits that, contrary to Canada's assertion, Article 22.8 of 
the DSU does not specify that it is for the respon dent to show that it has removed the original 
measure.  According to the Eur opean Communities, "[i]f anything, Article 22.8 of the DSU seems to 
indicate that such an assessment should be carried out  by the complaining Memb er, since it is the one 
suspending concessions".
485  The European Communities adds that the use of the passive tense in the 
phrase "[t]he suspension of concessions ... shall only be  applied" appears to indicate the obligation for 
the Member suspending concessions to terminate tho se measures when the orig inal measure has been 
removed.  The European Communities contends that, in any event, it has effectively shown that the 
inconsistent measure, namely, Directive 96/33/EC , was removed, and both the Panel and Canada 
recognized that Directive 2003/74/EC was a different measure.   
3. The Panel's Findings under Article 23.2(a) of the DSU  
217. As regards the Panel's finding that the United States made a determination within the meaning 
of Article 23.2(a), the European Communities consid ers that the United States' appeal is based on a 
"wrong reading of the Panel's findings", because th e Panel did not make its finding based only on the 
statements made by the United States at the DSB meetings.486  Instead, the Panel took into account the 
statements made by the United States at the DSB mee tings and its decision to maintain its suspension 
of concessions as  evidence  that the United States had made a "determination" prohibited by 
Article 23.2(a) of the DSU.487  The European Communities disagrees  with the United States that the 
statements made at the DSB meetings lacked de finitiveness.  On the contrary, the United States 
expressed a " definitive judgement "488 concerning the WTO-consistency of Directive 2003/74/EC.  The 
European Communities dismisses the United States ' argument that it could not have made a 
determination within weeks of the notification of Directive 2003/74/EC, contending, instead, that the 
term "determination" does not contain any tempor al connotation.  The Eu ropean Communities also 
disagrees with the United States' view that the Pane l inferred the existence of a "determination" from 
inaction.  According to the Eur opean Communities, the United Stat es "actively considered" that 
Directive 2003/74/EC was WTO-inconsistent a nd "actively continued" the suspension of 
concessions.489  The European Communities further submits that, even if the negotiators of the DSU 
referred to Section 301 of the United States Trade Act of 1974, they did so as an example that was not 
                                                      
485European Communities' appellee's submission, para. 114. 
486Ibid., para. 119.  
487Ibid., para. 122. (original emphasis) 
488Ibid., para. 126. (original emphasis) 
489Ibid., para. 133. (emphasis omitted)  WT/DS321/AB/R 
 Page 91 
 
 
intended to be an exhaustive illustration of the t ypes of unilateral conduct prohibited by Article 23.  
The European Communities, moreover, rejects the Un ited States' contention that statements made at 
DSB meetings are diplomatic in na ture and have no legal effects, referring to the Appellate Body's 
observation in US – Upland Cotton (Article 21.5 – Brazil)  that certain statements  by the United States 
Government indicated that it was taking a measure for the purpose of complying.490  Additionally, the 
European Communities notes that the United States' st atements at the DSB meetings occurred in the 
particular context of seeking redress of a violation by continuing its application of sanctions against 
the European Communities.  The Eu ropean Communities also rejects th e United States' argument that 
the Panel failed to establish when the United St ates had made a determination in breach of 
Article 23.2(a).  In the European Communities' view , the Panel properly observed that the deadline by 
which a Member shall have recourse to the DSU in accordance with Article 23 "was not an issue 
before the Panel".491 
218. The European Communities further argues that th e Panel correctly found that Canada made a 
determination to the effect that a violation has o ccurred within the meaning of Article 23.2(a).  The 
European Communities maintains that Canada's statem ents at DSB meetings that it was not removing 
the suspension of concessions, together with the fact that it has maintained the suspension of 
concessions, provide a sufficient amount of firmness  or immutability indicatin g that Canada made a 
more or less final decision regarding the WTO-inc onsistency of Directive 2003/74/EC.  The European 
Communities explains that, because it had notified a new measure, which was different both legally 
and in substance, Canada needed to take a fina l decision regarding its conformity with the WTO 
agreements, which it did (as confirmed by its stat ements and the continuation of its suspension of 
concessions, as concluded by the Pa nel), and thus Canada made a "determination" in the sense of 
Article 23.2(a) without having recourse to the DSU. 
4. The Scope of the Panel's Manda te and the Panel's Suggestion  
219. Finally, the European Communities reiterates that, by ignoring the sequence of the legal 
claims made by the European Communities, the Pane l exceeded its terms of reference in examining 
the consistency of Directive 2003/74/EC with the  SPS Agreement , contrary to Articles 7 and 21.5 of 
the DSU.492  Moreover, the European Communities rep eats its request that the Appellate Body 
improve the Panel's suggestion—that the United Stat es and Canada should have recourse to the rules 
and procedures of the DSU—by making it explicit that  they must resort to Article 21.5 proceedings 
and cease the suspension of concessions without delay.   
                                                      
490European Communities' appellee's submission, para . 131 (referring to Appellate Body Report, US – 
Upland Cotton (21.5 – Brazil) , para. 204). 
491Ibid., para. 134 (quoting Panel Report, US – Continued Suspension , para. 7.232). 
492See supra , paras. 55-58. WT/DS321/AB/R 
Page 92  
 
G. Arguments of the Third Participants 
1. Australia 
 
(a) Procedural Issue – Public Observation of the Oral Hearing  
220. Australia supports the request of the particip ants to allow public observation of the oral 
hearing in these proceedings.  Australia considers that enhancing the transparency of WTO dispute 
settlement proceedings can enhance the credibility of the dispute settlement system, and endorses the 
participants' arguments as to the value of open h earings.  Australia submits that, although the first 
sentence of Article 17.10 "would seem to preclude a re quest that hearings of the Appellate Body be 
held in public", this provision must be read togeth er with other provisions in the DSU, in particular, 
Article 17.10, second sentence, Article 17.14, and Article 18.2.493  According to Australia, "[i]n order 
to allow meaning to be given to these other provisions, the apparent in junction in the first sentence of 
Article 17.10 cannot be absolute."494  Australia observes that Article  17.10, second sentence, foresees 
that Appellate Body reports will contain sufficient information concerning the parties' statements and 
arguments to provide a basis for the Appellate Body 's findings.  It adds that the requirement in 
Article 17.14 that Appellate Body reports be ci rculated to WTO Members prior to adoption "would 
not be possible if the first sentence of Article  17.10 imposed an absolute requirement of 
confidentiality".495  Australia also refers to Article 18.2 of the DSU and states that there is no 
difference between parties disclosing statements c ontemporaneously by pub lishing them on a website 
and disclosing them by making them in an open h earing.  Finally, Australia observes that in the 
absence of an express prohibition in the DSU precl uding an open hearing, the Appellate Body should 
authorize the participants' request, which "would be fully consonant with the object and purpose of the 
DSU".496   
(b) Articles 21, 22, and 23 of the DSU 
221. Australia submits that, although the DSU do es not expressly provide procedures to be 
followed in the post-retaliation stage of a dispute, par ties' actions should continue to be guided by the 
following two fundamental principles:  (i) multilateral determination of non-comp liance;  and (ii) that 
the party asserting non-compliance bears the burden of establishing a  prima facie  case.   
222. Australia asserts that Article 23.1 of the DSU establishes an over arching obligation for 
Members to have recourse to the rules and procedur es of the DSU, including Article 21.5 of the DSU.  
                                                      
493Australia's comments on participants' request for an open hearing, p. 1. 
494Ibid., p. 2.  
495Ibid. 
496Ibid.  WT/DS321/AB/R 
 Page 93 
 
 
Australia emphasizes that Article 21.5 is the govern ing provision in cases of disagreement regarding 
the WTO-consistency of a measure taken to comp ly with the DSB's recommendations and rulings, 
and it also applies to disagreements as to whether an inconsistent measure has been removed within 
the meaning of Article 22.8 of the DSU.  Thus, Au stralia agrees with the European Communities that 
the disagreement regarding whether Directiv e 2003/74/EC removed the measure found to be 
inconsistent with the covered agreements in EC – Hormones  should have been resolved through 
recourse to Article 21.5 panel proceedings.  On this basis, Australia submits that the Panel erred in 
finding that the procedure under Article 21.5 of th e DSU could be merely one of the mechanisms 
available.   
223. Australia notes that the DSU is silent as to  whether the suspension of concessions should 
cease when disputes arise regarding the removal of an inconsistent measure within the meaning of 
Article 22.8.  According to Australia, it is ope n to a Member to continue the suspension of 
concessions pending the outcome of the Article 21.5  panel proceedings.  Despite recognizing that 
Article 21.5 does not expressly address the issue of which party may initiate Article 21.5 proceedings, 
Australia argues that the Panel erred in  relying on the unadopted panel report in EC – Bananas III 
(Article 21.5 – EC)  for its finding that "proceedings under Article 21.5 are [not] open only to the 
original complainant."497 
224. Australia notes that panels cannot rule on cl aims that have not been brought by the 
complaining party.  Australia argues that none of the provisions of the  SPS Agreement  were within 
the Panel's terms of reference, and the Panel had no jurisdiction to  consider the consistency of 
Directive 2003/74/EC with that Agreement.  Au stralia contends that allowing claims under the 
SPS Agreement  in this dispute would effectively reverse the burden of proof between the parties and 
"is inconsistent with the fundamental principl e ... that the party asserting non-compliance with a 
covered agreement bears the burden of establishing a  prima facie  case".498 
(c) The Panel's Selection of Experts 
225. Australia agrees with the argument of the Eur opean Communities that panels must observe 
due process in both selecting and consulting with e xperts.  Australia contends that fundamental 
fairness and due process "permeates all aspects of the WTO dispute settlement process, including a 
panel's use of experts".499  Australia then maintains that the principle of due process equally informs 
Articles 11 and 13.2 of the DSU and Article 11.2 of the  SPS Agreement  and that, in selecting and 
                                                      
497Australia's third participant's submission, paras. 11-13 (quoting Panel Report, US – Continued 
Suspension , para. 7.355;  and Panel Report, Canada – Continued Suspension , para. 7.353). 
498Ibid., para. 25. 
499Ibid., para. 48. WT/DS321/AB/R 
Page 94  
 
consulting experts under these provisions, a panel is  "duty bound to ensure that due process is 
respected".
500 
226. Citing the Appellate Body's finding in US – 1916 Act  that the discretionary authority to grant 
enhanced participatory rights to third parties is "circumscribed, for example, by the requirements of 
due process"501, Australia submits that a panel's discretion in  the use of experts under Article 13.2 of 
the DSU and Article 11.2 of the  SPS Agreement  must be similarly circumscribed by the requirements 
of due process.  Due process, Australia argu es, requires that panels "seek, and take  full  account of, 
the views of the parties on the types of experts re quired and the suitability of individual experts".502  
They must also take full account of the views of the parties on the substance of the advice to be 
sought from the experts and must not seek advice from any particular expert on matters outside their 
field of expertise.  WTO Members have recognized in the  Rules of Conduct  that experts must be 
"independent and impartial" and "avoid direct and indirect conflicts of interest".503 
(d) Articles 5.1 and 5.7 of the  SPS Agreement  
227. Australia asserts that the  SPS Agreement  balances the right to take measures to protect 
human, animal, or plant life or health against the tr ade liberalization goals of the WTO.  It adds that 
"[t]his balance cannot be maintain ed if panels fail to apply ap propriate standards of review."504  
Australia therefore agrees with the European Co mmunities that the application of the appropriate 
standard of review by panels is fundamental to their assessment of the consistency of a Member's 
measure with its obligations under the  SPS Agreement .  The standard of review applicable in this case 
refers to the nature and appropr iate intensity of scrutiny of a panel's evaluation of a Member's 
regulatory judgement or an assessment made by a competent body relied upon by that Member.  The 
applicable standard of review addresses the thres hold circumstance in which a panel may legitimately 
interfere in that judgement or factual assessment.  As the Appellate Body has explained, the standard 
of objective assessment of the facts provided in  Article 11 of the DSU "precludes [either] a  de novo  
review or 'total deference' by a panel to the findings of a national authority".505  Australia also agrees 
with the European Communities that  the appropriate standard of re view to be applied in a given 
dispute shall be informed "by both Article 11 of th e DSU and the particular covered agreement(s) and 
obligations at issue".506  Australia argues that this is supported by the Appellate Body's finding in 
US – Softwood Lumber VI (Article 21.5 – Canada)  that the proper standard of review to be applied by 
                                                      
500Australia's third participant's submission, para. 49.  
501Ibid., para. 50 (quoting Appellate Body Report, US – 1916 Act , para. 150). 
502Ibid., para. 51. (original emphasis) 
503Ibid., para. 51. 
504Ibid., para. 28. 
505Ibid., para. 30 (referring to Appellate Body Report, EC – Hormones , para. 117).  
506Ibid., para. 31 (referring to European Commun ities' appellant's submission, para. 224).   WT/DS321/AB/R 
 Page 95 
 
 
a panel must "be understood in the light of the specifi c obligations of the relevant agreements that are 
at issue".507 
228. Australia maintains that the standard of review  to be applied by panels "may vary between 
different obligations under the SPS Agreement " and must reflect the "balance between regulatory 
autonomy and international supervision"508 that is reflected in that Ag reement.  In Australia's view, 
the most significant limitation imposed by the text of the SPS Agreement on a panel's fact-finding 
jurisdiction is provided in Article 5.1.  Artic le 5.1 imposes a "positive obligation on Members to 
obtain and rely upon a risk assessment that is appropriate to the circumstances".509  This obligation 
requires that a "rigorous investigative and fact-finding process  compulsorily precedes "510 any review 
by a WTO panel of the relevant SPS measure.  Theref ore, a panel may not "usurp the role of a risk 
assessor"511 by conducting the risk assessment it self, because doing so would "nullif[y]"512 the 
competence retained by Members under Article 5.1 of the  SPS Agreement  and would amount to a 
de novo  review inconsistent with Article 11 of the DSU.   According to Australia, panels must accord 
"considerable deference (but not to tal deference)" to a Member's risk assessment where that Member 
has performed a "comprehensive and transparent" risk assessment.513  This is consistent with the 
requirement in Article 5.1 that a risk assessment be "as appropriate to the circumstances".  This 
requirement suggests that risk assessors may tailor th eir risk assessment to the specific circumstances 
of a case, and that a panel may not attempt to choose between such a ri sk assessment and an 
alternative assessment that is not "similarly embedded"514 in the specific circumstances. 
229. Australia submits that, where the available sci entific evidence may be susceptible to more 
than one interpretation by a "qualified and respected source"515, a panel must accord deference to a 
Member's risk assessment, even where the panel's ow n preferred view appears to be supported by the 
"'preponderant' weight of the evidence".516  Accordingly, a panel must not interfere with a Member's 
risk assessment solely because it might have drawn di fferent conclusions on the basis of the available 
evidence, and must limit the scope of its review to determining whether "the risk assessor's decision 
[is] objective and credible".517  For these reasons, Australia agre es with the European Communities
                                                      
507Australia's third participant's submission, para. 31 (quoting Appellate Body Report, US – Softwood 
Lumber VI (Article 21.5 – Canada) , para. 92). 
508Ibid., para. 34.  
509Ibid., para. 35.  
510Ibid., para. 36. (original emphasis) 
511Ibid., para. 36.  
512Ibid.  
513Ibid. 
514Ibid., para. 37.  
515Ibid., para. 38 (quoting Appellate Body Report, EC – Hormones , para. 194).  
516Ibid. (referring to Appellate Body Report, EC – Asbestos , para. 178).   
517Ibid., para. 39.  WT/DS321/AB/R 
Page 96  
 
that the Panel in this dispute misunderstood and mi sapplied the appropriate standard of review under 
Article 5.1 of the  SPS Agreement .  Although the Panel may have be nefited from obtaining divergent 
scientific views for purposes of its background unders tanding, it could not deliberately place itself in a 
position whereby it could choose the scientific opini on it preferred.  Yet, the Panel's various 
statements suggest that the Panel erroneously cons idered that its role was "to choose a position from 
among the different scientific views".
518  For example, the Panel stated that "its situation [was] 
similar"519 to that of a risk assessor and that it "followe d the majority of experts expressing concurrent 
views" or accepted the "most specific" or "best supported"520 views among the experts.  Australia 
maintains that the Panel should have focused on "w hether the European Comm unities' risk assessment 
represented an objective and credible view"521 from a qualified and respected source.  
230. In addition, Australia contends that a partic ular risk assessment may support a range of 
possible measures, and that Members retain the discretion to select the most appropriate measure to 
address a particular risk "taking into account the relevant circumstances and its appropriate level of 
protection".522  Australia submits that the "fundamental importance of the non-trade objectives of SPS 
measures" warrants "considerable deference"523 by panels to the regulatory decision-making of 
Members, in particular, where the scientific evidence supports more th an one credible interpretation. 
231. Furthermore, Australia shares the European Co mmunities' concerns regarding the relevance 
attributed by the Panel to the existence of interna tional standards for four of the hormones subject to 
the provisional ban.  Although international standard s may be relevant in interpreting provisions of 
the  SPS Agreement , they are not "dispositive"524 of the meaning of these provisions and should not be 
"elevated"525 to binding treaty obligations.  For this r eason, Australia agrees with the European 
Communities that the "existence of international sta ndards is not determinative of whether there is 
sufficient evidence to conduct a risk assessment under the first requirement of Article 5.7."526  
Australia considers that the Panel's approach failed to adequately take into account Article 3.3 of the 
SPS Agreement , which permits Members to take SPS measu res that result in a higher level of 
protection than would be achieved by measures ba sed on the relevant international standards.  
                                                      
518Australia's third participant's submission, para. 42.  
519Ibid., para. 41 (quoting Panel Report, US – Continued Suspension , para. 7.418;  and Panel Report, 
Canada – Continued Suspension , para. 7.409).  
520Ibid., para. 42 (quoting Panel Report, US – Continued Suspension , para. 7.420;  and Panel Report, 
Canada – Continued Suspension , para. 7.411).  
521Ibid., para. 42.  
522Ibid., para. 44 (referring to Panel Report, EC – Approval and Marketing of Biotech Products , 
para. 7.1525).  
523Ibid., para. 45.  
524Ibid., para. 54 (referring to Panel Report, EC – Approval and Marketing of Biotech Products , 
paras. 7.241, 7.300, and 7.314).  
525Ibid., para. 54. 
526Ibid., para. 55 (referring to European Communities' appellant's submission, paras. 392 and 393).    WT/DS321/AB/R 
 Page 97 
 
 
2. Brazil  
(a) Procedural Issue – Public Observation of the Oral Hearing  
232. Brazil "strongly disagrees"527 with the participants' request that the Appellate Body allow 
public observation of the oral hearing in these proceedings.   
233. Brazil observes that the term "proceedings" is defined as "the business transacted by a 
court"528, whereas "deliberations" is defined as "careful  consideration, weighing up with a view to 
decision;  ... consideration and discussion of a qu estion by a legislative assembly, a committee, etc.; 
debate".529  According to Brazil, the ordinary meaning leaves no doubt that the terms "proceedings" 
and "deliberations" are "not inte rchangeable", and that "proceedings " is a far broader concept than 
"deliberations" and encompasses the latter and a wide  variety of steps taken by Members or conducted 
by the Appellate Body, including hearings.530  Brazil further argues that the participants' interpretation 
of the term "proceedings" "runs counter to case-law", and notes that, in Canada – Aircraft , the 
Appellate Body interpreted the term "proceedings" as including "the conduct of the oral hearing".531 
Brazil observes, moreover, that Rule 28(1) of the  Working Procedures  "clearly sets out that the oral 
hearing is part of the appellate proceedings".532 
234. Brazil asserts that in the light of the ordinary  meaning of Article 17.10, the case-law, and the 
Working Procedures , there is no room for finding that "proceedings" are limited to "internal work" 
and exclude oral hearings, as alleged by the participants.533  Therefore, Brazil considers that the first 
sentence of Article 17.10 "must be construed as requiring the confidentiality of any written 
submissions, legal memoranda, written responses to  questions, oral statements, oral hearings, 
deliberations, exchange of views and all in ternal workings of the Appellate Body"534 and, 
consequently, opening the oral hearings to the public in  the appellate review stage is inconsistent with 
multilateral trading rules, despite the par ticipants' efforts to prove the contrary. 
235. Brazil does not see Article 18.2 as providing suppor t for the participants' request to open the 
oral hearing to public observation.  Brazil describ es Article 18.2 as granting a right to parties to 
disclose their own statements to the public.  Accordi ng to Brazil, the participants fail to show how a
                                                      
527Brazil's comments on participants' request for an open hearing, para. 2. 
528Ibid., para. 7 (referring to The New Shorter Oxford English Dictionary , 1990, p. 1204). 
529Ibid., para. 8 (referring to The New Shorter Oxford English Dictionary , 4th edn, L. Brown (ed.) 
(Clarendon Press, 1993), p. 624). 
530Ibid., para. 9.  
531Ibid., para. 10 (quoting Appellate Body Report,  Canada – Aircraft , para. 143). 
532Ibid., para. 11.   
533Ibid., para. 12 (referring to European Communities' request for an open hearing, para. 15). 
534Ibid., para. 12. WT/DS321/AB/R 
Page 98  
 
right granted by Article 18.2 to Members can modi fy the obligation established in Article 17.10, an 
obligation that is applicable not only to WTO Memb ers, but also to the Appellate Body.  Brazil 
cautions that accepting the participants' request "would lead to the absurd conclusion that, by mutual 
consent, the parties to a disput e can override multilateral rules".
535  Brazil adds that, by this logic, 
"mutual consent" would be a "blanket authori zation" to some Members to achieve goals not 
necessarily permitted by the multilaterally agreed rules;  in fact, "mutual consent", when 
contra legem , would undermine the whole purpose of a multilateral framework. 
236. Lastly, Brazil notes that transparency is an issue being discussed in the negotiations on the 
review of the DSU.  Brazil submits that, in the light of the different positions of Members on this 
issue and its impact on the functioning of the disput e settlement mechanism, "the authority to make a 
decision on whether or not to open panels' and Appe llate Body's proceedings to the public should lie 
with the WTO Membership as a whole, rather than  being introduced through the 'back door', as the 
result of a series of 'stand-alone requests'".536 
(b) Articles 21, 22, and 23 of the DSU 
237. Brazil asserts that the Panel erred in anal yzing the European Communities' claims under 
Articles 21.5, 23.1, and 23.2(a) of the DSU in "c omplete isolation" from the post-suspension context 
of this dispute and from the "systemic non-complian ce" by the European Communities.  Brazil also 
considers that the Panel erred in its acceptance, at least in part, of the European Communities' 
argument that this dispute is about a procedural vi olation.  According to Brazil, the focus of the 
dispute should not be the retaliatory measures by the United States and Canada;  rather, the focus 
should remain on whether the European Communitie s has complied with the DSB's recommendations 
and rulings in  EC – Hormones .  Brazil notes that Article 22.8 of the DSU sets out three conditions 
that must be met before termination of the suspension of concessions is required, with the first condition being the removal of the inconsistent measure.  Brazil contends that, because none of the 
conditions set out in Article 22.8 have been fulfille d, the DSB's authorization to suspend concessions 
granted to the United States and Canada remain s in place.  In Brazil's view, "the multilateral 
authorization to suspend concessions can  only be revoked by an equally  multilateral  ruling."
537   
238. Brazil disagrees with the Panel's finding that  the United States and Canada were seeking 
redress of a violation within the meaning of Artic le 23.1 of the DSU by continuing the multilaterally 
authorized suspension of concessions after the adoption of Directive 2003/74/EC.  According to 
Brazil, the European Communities' unilateral declar ation that its implementing measure complies with 
                                                      
535Brazil's comments on participants' request for an open hearing, para. 17. 
536Ibid., para. 18 (referring to Canada's request for an open hearing, para. 20). 
537Brazil's third participant's submissi on, para. 12. (original emphasis)  WT/DS321/AB/R 
 Page 99 
 
 
the DSB's recommendations and rulings, or the al leged presumption of good faith compliance, cannot 
turn the suspension of concessions authorized by th e DSB into an illegal measure.  Brazil adds that 
the authorization to suspend concessions was in ef fect at the time of the European Communities' 
declaration, and that the United States and Ca nada "were simply exercising a right duly and 
previously authorized".538  Brazil also takes issue with the Panel's interpretation of the term 
"determination" in Article 23.2(a) of the DSU.  Noting that the "determinations" prohibited under 
Article 23.2(a) are unilateral assessments of the kind examined in the US – Section 301 Trade Act   
dispute539, Brazil states that this provision is not inte nded to capture "[s]imple interventions and 
statements made at DSB or other WTO meetings".540  Brazil adds that the suspension of concessions, 
authorized by the DSB and obtained through recourse  to dispute settlement, cannot be considered to 
be a unilateral "determination". 
239. Turning to the Panel's analysis under Article 22.8 of the DSU, Brazil agrees with the Panel 
that the removal of the measure found to be incons istent must be understood as requiring substantive 
compliance.  Consequently, Brazil argues, the Panel' s analysis of Directive 2003/74/EC in the light of 
the  SPS Agreement  is of "paramount importance for providing an effective solution to the 
dispute".541  Brazil considers, in this regard, that pane ls have authority to examine issues or legal 
provisions not included in the terms of reference to the extent necessary for providing a prompt 
solution to the dispute. 
240. Finally, Brazil asserts that, in the post-retaliati on stage of a dispute, the original respondent 
bears the burden of proving that its implementing me asure is WTO-consistent.  According to Brazil, 
once an authorization is granted to a Member unde r Article 22.6 of the DSU to suspend concessions 
or other obligations, a turning point has been reache d in the procedures established in the DSU.  Thus, 
Brazil argues, where the original respondent has not complied with WTO rules for a long period of 
time despite the DSB's recommendations and rulings, the burden of making a  prima facie  case of 
compliance rests upon that party.  Brazil submits th at this "would not be a disproportionate burden" 
on the non-complying party because, in the "pos t-retaliation" stage, this Member "will have 
maintained an inconsistent measure for many years and the dispute settlement system should take this 
into consideration".542  Brazil is also of the view that the original respondent can initiate Article 21.5 
proceedings to establish compliance.  Brazil argues that  such an interpretation is consistent with the 
rationale that underpins Article 22.6 of the DSU,  which places the burden on the original respondent 
                                                      
538Brazil's third participant' s submission, para. 18. 
539Ibid., para. 21 (referring to Panel Report, US – Section 301 Trade Act , footnote 657 to para. 7.50). 
540Ibid., para. 21. 
541Ibid., para. 29. 
542Ibid., para. 34. WT/DS321/AB/R 
Page 100  
 
to demonstrate that the level of the suspension of concessions proposed by the complaining Member 
is not justified under the DSU.  
3. China
 
241. Pursuant to Rule 24(2) of the Working Procedures , China chose not to submit a third 
participant's submission.   
242. China submits that the request made by the par ticipants to open the oral hearing to public 
observation should be rejected by the Appellate Body.  China disagrees with the participants' 
interpretation of the term "proceedings" in Article 17 .10.  China states that the drafters of the DSU 
intentionally used the different terms "delibera tions" and "proceedings" in Articles 14.1 and 17.10, 
respectively.  China does not understand the term "proceedings" in Article 17.10 as referring "only to 
the internal work of the Appellate Body".543  China observes that the term  "proceedings" is also used 
in Article 17.5 of the DSU, which provides that "t he proceedings shall not exceed 60 days from the 
date a party to the dispute formally notifies its decision to appeal to the date the Appellate Body 
circulates its report".  Article 17.12 requires that the Appellate Body "address each of the issues raised in accordance with paragraph 6 during the appellate proceeding".  These provisions do not provide contextual support for the interpretation of "proceedi ngs" put forward by the participants.  In China's 
view, the requirement in Article 17.10 that the pr oceedings of the Appellate Body be confidential 
must be interpreted to mean that only the participan ts and third participants may be present at the oral 
hearing, and all written submissions to the Appellate Body are treated as confidential. 
243. China asserts, furthermore, that the purpose of th e oral hearing is to provide all participants 
with adequate opportunity to present and argue their case before the Division with the aim of 
clarifying the legal issues in the appeal.  Accordingl y, China considers that the "main task [of] the 
Division, when dealing with the oral hearing issues, is to provide such opportunity to all participants 
and secure their right and obligation under the current DSU."
544  China emphasizes that any 
determination by the Appellate Body in this app eal "shall not prejudice" the position of Members in 
the ongoing negotiations on the review of the DSU.545 
4. India  
244. India stresses that the Appellate Body should re ject the participants' request to allow public 
observation of the oral hearing in these proceedings .  India submits that "the issue of external
                                                      
543China's comments on participants' request for an open hearing, p. 1. 
544Ibid., p. 2. 
545Ibid.  WT/DS321/AB/R 
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transparency" is being discussed in the negotiati ons on the review of the DSU and that "[t]hese 
negotiations have not yet been completed, and th ere is no consensus on whether and which form of 
external transparency is accepta ble to the entire WTO Membership."546  India argues that until such 
consensus is achieved, panel and A ppellate Body proceedings have to be held in closed sessions.  
India emphasizes that the confidentiality of the pa nel and Appellate Body proceedings provided under 
the DSU is a "substantive" matter547, and any decision by the Appellate Body to open its proceedings 
to public observation necessarily involves consultati ons with, and decisions by, WTO Members, and 
not just the participants and third participants.   
5. Mexico  
245. Pursuant to Rule 24(2) of the  Working Procedures , Mexico chose not to submit a third 
participant's submission. 
246. Mexico disagrees with the request made by the participants to allow public observation of the 
oral hearing in these proceedings.  Mexico observes that its position is supported by Article 17.10 of 
the DSU, which states that "[t]he proceedings of  the Appellate Body shall be confidential."   
6. New Zealand  
(a) Procedural Issue – Public Observation of the Oral Hearing 
247. New Zealand supports the request of the particip ants to allow public observation of the oral 
hearing in these proceedings.  New Zeal and observes that Rule 27 of the  Working Procedures , which 
regulates the oral hearing, "makes no mention of confidentiality".548  New Zealand additionally notes 
that the DSU does not mention hearings at the Appe llate Body stage and therefore does not explicitly 
preclude opening such a hearing.  New Zealand also agrees with the participants that Article 17.10, 
"read in accordance with the rules of  treaty interpretation and in the context of other provisions in the 
DSU" does not preclude public observation of the or al hearing.  Therefore, New Zealand considers 
that the joint request of the participants to open the hearing of the Appellate Body in these 
consolidated appeals is neither inconsistent w ith, nor precluded by, the DSU, the other covered 
agreements, or the  Working Procedures .   
                                                      
546India's comments on participants' request for an open hearing, p. 1. 
547Ibid. 
548New Zealand's comments on participants' request for an open hearing, p. 1.  WT/DS321/AB/R 
Page 102  
 
(b) Articles 21, 22, and 23 of the DSU 
248. New Zealand submits that the Panel erred in fi nding that the United States and Canada have 
acted inconsistently with Articl es 23.1 and 23.2(a) of the DSU.  In New Zealand's view, the Panel 
should have interpreted Articles 23.1 and 23.2(a) in th e context of the other provisions of the DSU, in 
particular Article 22.8, which sets out three condi tions that must be met in order to have the 
suspension of concessions terminated.  New Z ealand maintains that the first condition under 
Article 22.8, which is the relevant one in this disp ute, refers to situations where the inconsistent 
measure has actually been removed, and not where the measure is merely claimed to have been 
removed.  Thus, New Zealand submits, because th e Panel found that the European Communities has 
not removed the inconsistent me asure within the meaning of Article22.8, the United States and 
Canada have every right to continue the suspensi on of concessions.  New Zealand contends that, by 
comparison, Article 23 is the "framework provision  setting up the requirement to have recourse to 
dispute settlement"
549 and does not address the specific situati on in this case, where the United States 
and Canada have already had recourse to dispute settlement.  New Zealand adds that Article 23 does 
not impose an obligation on the United States and Ca nada to cease the suspensi on of concessions or to 
resort to Article 21.5 proceedings.   
249. New Zealand maintains that, in reaching its finding of violation under Articles 23.1  
and 23.2(a) of the DSU, the Panel failed to consider the object and purpose of the DSU, which is to 
provide security and predictability to the multilatera l trading system.  New Zealand observes that the 
Panel's finding leads to the result that the Member  authorized to suspend concessions must terminate 
the suspension whenever the non-compliant Memb er notifies its adoption of an implementing 
measure to the DSB and then waits to be challenge d.  New Zealand adds that the Panel's approach 
"would almost inevitably give rise to the situation where an implementing Member could continually impose successive rounds of litigation at will, merely by asserting that it had complied"
550, thus 
undermining the predictability of the suspension of concessions and its importance in inducing prompt 
compliance.  New Zealand also argues that the Panel's examination of Articles 23.1 and 23.2(a) in 
isolation from Article 22.8 "reduce[s]" the latter provision "to redundancy or inutility".551 
250. New Zealand submits that the Panel's sugges tion that the United States and Canada should 
have recourse to the rules and procedures of the DSU without delay "is simply not tenable".552  Such a 
suggestion undermines the authorization to susp end concessions that the United States and Canada 
have obtained from the DSB.  This is incompatib le with the objective of  "prompt settlement" of 
                                                      
549New Zealand's third participant's submission, para. 3.21. 
550Ibid., para. 3.30. 
551Ibid., para. 3.36. 
552Ibid., para. 3.62.   WT/DS321/AB/R 
 Page 103 
 
 
disputes envisaged in Article 3.3 of the DSU, be cause it would result in a "redundant" proceeding in 
which a new panel would look at "an issue that was already dealt with in the context of the current 
proceedings".553 
(c) Terms of Reference 
251. New Zealand contends that the Panel erred in sta ting that it did not have jurisdiction to rule on 
the compatibility of Directive 2003/74/EC with the covered agreements.  New Zealand submits that 
the Panel should have explicitly determined the compatibility of Directive 2003/74/EC with the 
covered agreements because it had substantively revi ewed the Directive and had concluded that the 
measure found to be inc onsistent with the  SPS Agreement  in  EC – Hormones  had not been removed 
by the European Communities.  In New Zeal and's view, the Panel Report is sufficiently 
comprehensive for the Appellate Body to determine explicitly the compatibility of 
Directive 2003/74/EC with Articles 5.1 and 5.7 of the  SPS Agreement .  
(d) Articles 5.1 and 5.7 of the  SPS Agreement  
252. New Zealand "strongly"554 disagrees with the European Co mmunities' arguments in relation 
to Articles 5.1 and 5.7 of the  SPS Agreement   because they would "seriously undermine the principles 
and obligations"555 of that Agreement.  The  SPS Agreement  imposes a "very important" requirement 
that SPS measures be developed and implemented in  a manner that is "transparent, consistent, 
scientifically-based, and the least trade-restrictive"556, and this requirement is at the "forefront"557 of 
this dispute.  New Zealand recalls that Article 2.2 of the  SPS Agreement  imposes a general 
obligation that SPS measures be based on scientific principles and not maintained without sufficient 
scientific evidence.  This obligation is given specifi c application by Article 5.1, which requires that 
SPS measures be "based on" a risk assessment, which, according to the Appellate Body's 
interpretation, entails that there must be a "ra tional relationship between the measure and the risk 
assessment" whereby the results of  the risk assessment sufficiently warrant the SPS measures at 
stake.558  In New Zealand's view, the Panel correctly  concluded that Directive 2003/74/EC was not 
based on a risk assessment within the meaning of Arti cle 5.1.  The Panel's findings were supported by 
an exhaustive overview of all rele vant scientific evidence, drawin g upon the expertise and knowledge 
of a group of eminent scientific and technical experts.   
                                                      
553New Zealand's third participant's submission, para. 3.62 (quoting Canada's other appellant's 
submission, para. 96). 
554Ibid., para. 3.42. 
555Ibid., para. 3.43.  
556Ibid., para. 3.44.  
557Ibid., para. 3.45.  
558Ibid., para. 3.46 (referring to Appellate Body Report, EC –Hormones , para. 193).  WT/DS321/AB/R 
Page 104  
 
253. New Zealand states that the risk assessment at is sue in this dispute is the second type of risk 
assessment provided for in paragraph 4 of Annex A to the  SPS Agreement , which is "designed to 
protect from risks arising from additives, contam inants, toxins or disease-causing organisms in 
foodstuffs".
559  New Zealand recalls that, with regard to this type of risk assessment, the Appellate 
Body indicated in  EC – Hormones  that a Member is required to "identify the adverse effects on 
human or animal health (if any) arising from the pr esence of such additives, contaminants, toxins or 
disease-causing organisms in foodstuffs", and, "if an y adverse effects exist, evaluate the potential 
(or possibility) of the occu rrence of such effects."560  The Appellate Body also found that "the 'risk' 
evaluated in a risk assessment must be ascertainable —'theoretical uncertainty is not the kind of risk 
which ... is to be assessed'."561  New Zealand also refers to the panel's finding in  Japan – Apples  that 
a panel's review of a measure under Article 5.1 woul d also involve an evaluation of whether the risk 
assessment was "as appropriate to the circum stances", and whether it took into account "risk 
assessment techniques developed by the relevant international organizations."562  New Zealand recalls 
further the Appellate Body's finding in  EC – Hormones  that the European Communities "did not 
actually proceed to an assessment, within the meaning of Articles 5.1 and 5.2, of the risks arising from 
the failure of observance of good veterinary practice combined with problems of control of the use of 
hormones for growth promotion purposes."563  New Zealand concludes that, as in  EC – Hormones , 
the European Communities "once again"564 has failed to demonstrate that the risk assessment 
underlying Directive 2003/74/EC satisfies the requirements of the  SPS Agreement .  
254. New Zealand argues that, as the Member invoki ng Article 5.7, the European Communities 
bears the burden of demonstrating that the four requ irements of Article 5.7 have been met, including 
the requirement that the measure be imposed in a situation where relevant scientific evidence is 
"insufficient".565  New Zealand recalls the Appellate Body's finding that these four requirements are 
"cumulative"566, and that, whenever one of them is not met, the measure at issue is inconsistent with 
Article 5.7.  New Zealand asserts that European Communities has failed to demonstrate that it has 
satisfied any of the requirements under Article 5.7 with respect to Directive 2003/74/EC.   
                                                      
559New Zealand's third participant's submission, para. 3.52.  
560Ibid. (referring to Appellate Body Report, EC – Hormones , para. 183). (emphasis omitted) 
561Ibid., para. 3.53 (quoting Appellate Body Report, EC – Hormones , para. 186).   
562Ibid., para. 3.54 (quoting Panel Report, Japan – Apples , para. 8.236).   
563Ibid., para. 3.55 (quoting Appellate Body Report, EC – Hormones , para. 208).  
564Ibid., para. 3.56.  
565Ibid., para. 3.58 (referring to Panel Report, Japan – Apples , para. 8.212).  In addition, the other 
requirements are:  (i) the provisi onal SPS measure must be adopted on the "basis of available pertinent 
information";  (ii) the Member seeks to "obtain the additional information necessary for a more objective risk 
assessment";  and (iii) the Member reviews the measure "accordingly within a reasonable period of time".  
566Ibid., para. 3.59 (referring to Appellate Body Report, Japan – Agricultural Products II , para. 89).   WT/DS321/AB/R 
 Page 105 
 
 
7. Norway  
(a) Procedural Issue – Public Observation of the Oral Hearing 
255. Norway supports the participants' request that  the Appellate Body allow public observation of 
the oral hearing in these proceedings.  Norway asserts  that the meaning of the term "proceedings" in 
isolation is not unequivocal, and resort must be had to context and object and purpose as set out in 
Article 31(1) of the  Vienna Convention on the Law of Treaties567 (the " Vienna Convention ").  Turning 
to Articles 17.5 and 17.12 of the DSU as contex t, Norway recognizes that these provisions use the 
term "proceedings" "as 'short-hand' for all stages in an appeal", but it considers that this is "not 
dispositive in itself".568  Norway also recognizes that Article 17.10 is drafted differently from 
Article 14.1, which uses the term "deliberations", bu t it does not consider that this implies that the 
term "proceedings" in the first sentence of Article 17. 10 must be read to require confidentiality of the 
oral hearing before the Appellate Body.  Norway asserts that it "cannot see that the object and purpose 
of Article 17.10 is different from [that of] Article 14 .1 of the DSU, which is to protect the internal 
work of panels" and argues that "[t]he object and purpose thus indicates that the term 'proceedings' in 
Article 17.10 should be given a restrictive interp retation, focussing on the internal work of the 
Appellate Body, and not encompass[ing] the oral hearing."569  Norway submits that a restrictive 
interpretation of "proceedings" is also supported by  the Spanish and French versions of the DSU 
referring to the term " actuaciones " in Spanish and the term " travaux " in French, in accordance with 
Article 33 of the  Vienna Convention .  Norway finds further support for a restrictive interpretation of 
the term "proceedings" in the fact that Article 18. 2 specifically authorizes parties to a dispute to 
disclose their submissions and statements to the public.  In Norway's view, Article 18.2 cannot be 
interpreted to require "more confid entiality than the parties require".570  
256. Norway thus considers that the DSU allows th e Appellate Body to open the oral hearing to 
the public where all participants to the dispute so request and that the Appellate Body has discretion 
under Rule 16(1) of the  Working Procedures  to respond favourably to the request.  Norway states 
that allowing public observation will bring the Appellate  Body more into line with other international 
tribunals where "open hearings is the norm".571 Norway further considers that allowing public 
observation "will be beneficial to the process and to  the legitimacy of the Appellate Body's work".572 
                                                      
567Done at Vienna, 23 May 1969, 1155 UNTS 331;  8 International Legal Materials 679. 
568Norway's comments on participants' re quest for an open hearing, para. 15. 
569Ibid., para. 23. 
570Ibid., para. 37. 
571Ibid., para. 39. 
572Ibid. WT/DS321/AB/R 
Page 106  
 
(b) Articles 21, 22, and 23 of the DSU 
257. Norway maintains that Article 22.8 of the DSU requires that the suspension of concessions be 
temporary and conditional.  Norway emphasizes that once compliance is achieved, be it through a 
simple revocation of the inconsiste nt measure or its replacement with another measure that ensures 
compliance, the right to suspend concessions " automatically  lapses"
573 without a need for formal 
revocation of the authorization by the DSB.  Norway submits that, where the parties disagree as to whether the measure taken to comply actually achieves compliance, as is the case in this dispute, the 
parties must resort to Article 21.5 panel proceedi ngs.  Once a panel (and the Appellate Body, if the 
panel report is appealed) determines that the im plementing measure brings the Member concerned 
into compliance with the recommendations and rulings  of the DSB, "the previous authorization [to 
suspend concessions] lapses  ipso facto  once the report is adopted, without there being a need for the 
DSB to revoke it formally as the tem poral condition ... no longer exists".
574   
258. Norway further submits that a presumption of  good faith compliance is applicable under the 
DSU, and the original complainant who considers th at the measure taken to comply fails to achieve 
compliance has an obligation to initiate Article 21. 5 proceedings.  Noting that Articles 22.8 and 21.5 
do not set forth any time-limits for initiating Article  21.5 proceedings, Norway claims that this does 
not mean that the original complainant may simply  refuse to launch such proceedings.  In Norway's 
view, beyond a certain point in time, Article 23.2( a) may be breached.  To avoid unreasonable delays, 
Article 21.5 should be interpreted to allow both the original complainant and the original respondent 
to initiate Article 21.5 proceedings.  Norway contends  that Article 21.5 is written in the passive form 
without specifying which party may initiate the proc eedings and, consequently, this provision allows 
both parties to launch Article 21.5 proceedings.  The fact that the compliance panel report in  EC – 
Bananas III (Article 21.5 – EC)  remained unadopted, and that the panel refused to make any 
recommendations or rulings, does not in itself prove that an original respondent may not invoke Article 21.5, because that case involved particular  circumstances that explain the outcome.   
259. Norway explains that, in Article 21.5 proceed ings launched by the original respondent, the 
panel may not "make a declaratory judgment based on  the presentation of the original respondent, but 
must make an objective assessment of the matter before it."
575  However, where the original 
complainant refuses to participate, any claim that  the new measure is inconsistent with other 
provisions of the covered agreements  will not be heard.  In such proceedings, the original respondent 
may be considered as a "complainant" for purposes of  Article 6.1 and an "applicant" for purposes of 
                                                      
573Norway's third participant's submission, para. 6. (original emphasis) 
574Ibid., para. 7. 
575Ibid., para. 15.  WT/DS321/AB/R 
 Page 107 
 
 
Article 6.2 of the DSU.  The requirements of Article  6.2 can be fulfilled by referring to the original 
panel and Appellate Body reports, together with the identification of the specific measure taken to 
comply and a description of how it ensures complian ce.  Norway adds that, in such proceedings, 
"[o]nly the violations specifically addressed"576 in the panel and Appellate Body reports in the original 
dispute will be within the Article 21.5 panel's term s of reference.  This is because the original 
respondent does not complain about specific violations by other Members, but asks for a "declaratory 
finding"577 of compliance with the DSB's recommendations a nd rulings in the original dispute.  By not 
launching Article 21.5 panel proceedings first, the original complainant loses certain rights to present 
new claims that it would have been able to include in the panel's terms of re ference if it had initiated 
the Article 21.5 proceedings a nd submitted the request for the establishment of a panel.  
Consequently, Norway submits that allowing th e original respondent to launch Article 21.5 
proceedings would provide the original complainan ts with the incentive to launch Article 21.5 panel 
proceedings first. 
8. Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu  
260. Pursuant to Rule 24(2) of the  Working Procedures , the Separate Customs Territory of 
Taiwan, Penghu, Kinmen and Matsu chose not to submit a third participant's submission.   
261. The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu supports the request 
of the participants to allow public observation of th e oral hearing in these proceedings "in the interests 
of greater transparency".578 
III. Issues Raised in This Appeal 
262. The following issues are raised on a ppeal by the European Communities: 
(a) Whether the Panel erred in failing to find that the United States and Canada had to 
initiate proceedings pursuant to Article 21.5 of  the DSU in order to comply with their 
obligations, under Articles 23.1 and 23.2(a), to have recourse to the rules and 
procedures of the DSU; 
(b) Whether the Panel erred in finding that Ar ticle 22.8 of the DSU was not breached by 
the United States and Canada because th e European Communities has failed to 
comply with the recommendations and rulings of the DSB in  EC – Hormones , which 
                                                      
576Norway's third participant's submission, para. 17. 
577Ibid., para. 18. 
578Comments of Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu on participants' 
request for an open hearing, p. 1. WT/DS321/AB/R 
Page 108  
 
underlie the authorization given to th e United States and Canada to suspend 
concessions and other obligations; 
(c) Whether the Panel exceeded its terms of reference by examining the compatibility of 
Directive 2003/74/EC
579 with Articles 5.1 and 5.7 of the  SPS Agreement ; 
(d) Whether the Panel erred by failing to make the suggestion, pursuant to its authority 
under Article 19.1 of the DSU, that the United States and Canada cease the 
suspension of concessions and resort to Article 21.5 proceedings, or any other 
proceedings to which the parties may agree,  to resolve any disagreements as to the 
consistency of Directive 2003/74/EC with the  SPS Agreement ; 
(e) Whether the Panel failed to respect the prin ciple of due process, and therefore failed 
to comply with its duties under Article 11 of the DSU, in selecting, and relying upon 
the advice of, two experts who were not "i ndependent and impartial" as required by 
the  Rules of Conduct ; 
(f) Whether the Panel erred in interpreti ng and applying Article 5.1 of the  SPS 
Agreement   in assessing the consistency of the import ban on meat from cattle treated 
with oestradiol-17 β for growth-promotion purposes, applied pursuant to 
Directive 2003/74/EC, in particular by: 
(i) adopting a narrow interpretation of "ris k assessment" and failing to take into 
account evidence on misuse and abuse in the administration of hormones; 
(ii) requiring the European Communities to eval uate specifically the risks arising 
from the presence of residues of oestradiol-17 β in meat or meat products as a 
result of the cattle being treated with  this hormone for growth-promotion 
purposes; 
(iii) imposing a quantitative method of risk assessment on the European 
Communities; 
(iv) incorrectly allocating the burden of proof;  and 
                                                      
579Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 
amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, Official Journal of the European 
Union , L Series, No. 262 (14 October 2003) 17 (Exhibits EC-1 and US-3 submitted by the European 
Communities and the United States, respectively, to the Panel).  WT/DS321/AB/R 
 Page 109 
 
 
(v) failing to make an objective assessment of the matter before it, as required by 
Article 11 of the DSU, by articulating and applying an incorrect standard of 
review. 
(g) Whether the Panel erred in interpreti ng and applying Article 5.7 of the  SPS 
Agreement   when assessing the consistency of the provisional import ban on meat 
from cattle treated with testosterone, progesterone, trenbolone acetate, zeranol, and 
melengestrol acetate ("MGA") for growth-promotion purposes, applied under 
Directive 2003/74/EC.  More specifically, whet her the Panel erred in finding that the 
relevant scientific evidence was insufficient because it: 
(i) incorrectly found that the determinati on of whether the relevant scientific 
evidence is insufficient "must be disc onnected" from the chosen level of 
protection; 
(ii) articulated and applied an incorrect legal test pursuant to which, where 
international standards exist for a substance, a "critical mass of new scientific evidence" is required to render the rele vant scientific evidence "insufficient";  
(iii) incorrectly allocated the burden of proof;  and 
(iv) failed to make an objective assessment of the matter before it, as required by 
Article 11 of DSU. 
263. The following issues are raised on app eal by the United States and Canada: 
(a) Whether the Panel erred in finding that th e United States and Canada were seeking 
the redress of a violation within the meaning of Article 23.1 of the DSU, by maintaining the suspension of con cessions after the notification of 
Directive 2003/74/EC by the European Communities; 
(b) Whether the Panel erred in finding that  the United States and Canada made a 
unilateral determination that Directive 2003/ 74/EC is not consistent with the WTO 
agreements without recourse to the rules and procedures of the DSU, in breach of Article 23.2(a) of the DSU. 
264. In the event that the Appellate Body were to uphold the Panel's finding that the United States 
and Canada acted inconsistently with Articles 23.2(a) and 23.1 of the DSU, the United States and 
Canada conditionally appeal the following issues: WT/DS321/AB/R 
Page 110  
 
(a) Whether the Panel erred in concluding that  it was not called upon, and hence did not 
have jurisdiction, to determine the co mpatibility of Directive 2003/74/EC with 
Articles 5.1 and 5.7 of the  SPS Agreement ; 
(b) Whether the Panel erred in suggesting, pursu ant to Article 19.1 of the DSU, that the 
United States and Canada have recourse to the rules and procedures of the DSU 
without delay. 
IV. The Application of the DSU in the Post-Suspension Stage of a Dispute 
A. Introduction 
265. We begin with the issues raised on appeal by Canada, the European Communities, and the 
United States relating to the interpretation and appl ication of several provisions of the DSU in the 
post-suspension stage of a dispute.  This stag e refers to the period after a WTO Member has 
suspended concessions or other obligations to another Member
580, having received authorization to do 
so from the DSB.  The authorization to suspend co ncessions stems from the other Member's failure to 
bring into compliance measures that have been found to be inconsistent with the covered agreements 
by a panel or the Appellate Body. 
266. This appeal relates to the  EC – Hormones  dispute in which, following a complaint by the 
United States and Canada, the ban imposed by the European Communities on imports of meat from 
cattle treated with growth-promoting hormones, pursuant to Directive 96/22/EC, was found to be 
inconsistent with the  SPS Agreement .581  Because the European Communities failed to bring itself 
into compliance within the reasonable peri od of time, which expired on 13 May 1999582, the United 
States and Canada requested the DSB to authorize suspension of concessions pursuant to Article 22.2 
of the DSU.583  The United States and Canada obtained authorization from the DSB to suspend 
concessions in relation to the European Communities on 26 July 1999, following an arbitration at the 
European Communities' request.584  On 29 July 1999, the United States applied 100 per cent import 
duties on a range of imports from certain me mber States of the European Communities.585  
                                                      
580We will use the term "suspension of concessions" as an abbreviated reference to "the suspension of 
concessions or other obligations".   
581Appellate Body Report, EC – Hormones , para. 253. 
582Award of the Arbitrator, EC – Hormones , para. 48. 
583WT/DS26/19;  WT/DS48/17. 
584Decision by the Arbitrators, EC – Hormones (Article 22.6 – United States) , para. 84;  Decision by 
the Arbitrators, EC – Hormones (Article 22.6 – Canada) , para. 73.  See also WT/DS26/20;  WT/DS48/18. 
585See supra , footnote 17.  WT/DS321/AB/R 
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On 1 August 1999, Canada applied 100 per cent  ad valorem  duties on a similar range of imports 
from the European Communities.586 
267. After the adoption of the panel and Appellate Body reports in the  EC – Hormones  dispute, 
the European Commission commissioned 17 scientific st udies to assess the risks to human health posed 
by the six hormones at issue.587  On the basis of these studies and additional scientific information made 
available to the European Commission, the Scientif ic Committee on Veterinary  Measures relating to 
Public Health (the "SCVPH") issued three Opin ions in 1999, 2000, and 2002 concerning risks to human 
health posed by the six hormones.588  In the light of these Opinions, the European Communities adopted 
Directive 2003/74/EC on 22 September 2003589, which amends Directive 96/22/EC.  
Directive 2003/74/EC maintains the permanent pr ohibition on the importation of meat and meat 
products from animals treated with oestradiol-17 β for growth-promotion purposes originally 
contained in Directive 96/22/EC.590  In relation to the five other hormones—testosterone, 
progesterone, trenbolone acetate, zeranol, and MGA—Directive 2003/74/EC imposes the prohibition on a provisional basis.
591  Directive 2003/74/EC specifies that, even though the scientific information 
available showed the existence of risks associated  with these substances, "the current state of 
knowledge does not make it possible to give a qua ntitative estimate of the risk to consumers".592  The 
prohibition of these five hormones applies "while the Community seeks more complete scientific information from any source, which could shed li ght and clarify the gaps in the present state of 
knowledge of these substances".
593   
268. On 27 October 2003, the European Communities notified the DSB of the adoption, 
publication, and entry into force of Directive 2003/74/EC, as well as the 1999, 2000, and 2002 Opinions, which it considered provided a sufficien t justification for the permanent and provisional 
prohibitions on the importation of meat from ca ttle treated with the six hormones under the  SPS 
Agreement .
594  The European Communities therefore claime d that it had fully implemented the DSB's 
recommendations and rulings in the original  EC – Hormones  dispute, and consequently considered 
that the suspension of concessions by the United St ates and Canada was no longer justified.  The 
United States and Canada refused to lift the su spension of concessions imposed pursuant to the 
authorization obtained from the DSB, because they did not consider that Directive 2003/74/EC had 
                                                      
586See supra , footnote 18. 
587See supra , footnote 19. 
588See supra , footnotes 20, 21, and 22. 
589See supra , footnote 5.  
590Directive 2003/74/EC, supra , footnote 5, Recital 10 and Article 1 (amending Articles 2 and 3 of 
Directive 96/22/EC).   
591Ibid. 
592Directive 2003/74/EC, supra , footnote  5, Recital 7.   
593Ibid., Recital 10.  
594WT/DS26/22;  WT/DS48/20.  WT/DS321/AB/R 
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brought the European Communities into complianc e with the DSB's recommendations and rulings.
595  
The European Communities initiated the present pr oceedings alleging that the United States and 
Canada acted inconsistently with their obligatio ns under the DSU by continuing the suspension of 
concessions.596  
269. A summary of the findings of the Panel is provided in section B and the claims and arguments 
raised on appeal are described in section C.  In sect ions D and E we address the claims raised by the 
European Communities, including whether Article  22.8 of the DSU required the United States and 
Canada to cease the application of the suspensi on of concessions upon the European Communities' 
notification of Directive 2003/74/EC, and whether the United States and Canada were required to 
initiate Article 21.5 proceedings if they did not consider that Direc tive 2003/74/EC is consistent with 
the covered agreements.  Section F addresses the claims raised by the United States and Canada in 
their other appeals concerning the Panel's findings th at they breached Articles 23.2(a) and 23.1 of the 
DSU by seeking the redress of a violation without recourse to the rules and procedures of the DSU.  Section G addresses the conditional claims raised by the United States and Canada in relation to the 
Panel's finding that it did not have jurisdiction to  determine the compatibility of Directive 2003/74/EC 
with the covered agreements.  Finally, section H a ddresses the issues raised by all three participants 
concerning the suggestion made by the Panel pursuant to Article 19.1 of the DSU.   
B. The Panel's Findings 
1. Scope of the European Communities' Claims
 
270. Before the Panel, the European Communities ra ised "two sets of main claims" against the 
continued suspension of concessions by the United St ates and Canada.  It asserted that the continued 
suspension is inconsistent with:  (i) Article 23.2(a) , read together with Articles 21.5 and 23.1 of the 
DSU;  and (ii) Article 23.1, read in conjunction w ith Articles 22.8 and 3.7 of the DSU.  In addition, 
the European Communities ra ised claims under Articles I and II of the GATT 1994.597  In the event 
that the Panel found no violation of Article 23 of the DSU, the European Co mmunities claimed, in the 
                                                      
595WT/DSB/M/157;  WT/DSB/M/159.   
596In December 2004, the United St ates requested information fr om the European Communities 
pursuant to Article 5.8 of the  SPS Agreement  concerning the justification underlying Directive 2003/74/EC.  
(Panel Report, US – Continued Suspension , para. 7.227)  The Panel was established on 14 January 2005 at the 
European Communities' request.  (Panel Report, US – Continued Suspension , para. 1.2;  Panel Report, Canada – 
Continued Suspension , para. 1.2) 
597Panel Report, US – Continued Suspension , para. 3.1;  Panel Report, Canada – Continued 
Suspension , para. 3.2.  WT/DS321/AB/R 
 Page 113 
 
 
alternative, that the continued suspension by th e United States and Canada is inconsistent with 
Article 22.8 of the DSU.598 
271. At the outset of its analysis, the Panel made some preliminary remarks concerning the scope 
of its mandate.  The Panel recalled that the matter be fore it was the alleged failure of the United States 
and Canada to comply with their obligations under the DSU by maintaining the suspension of concessions authorized by the DSB in the  EC – Hormones  dispute, even though the European 
Communities had adopted Directive 2003/74/EC and notified this Directive to the DSB as the 
measure taken to comply.
599  The Panel noted that, in its first written submission, the European 
Communities divided its claims into "two main sets of claims" and one conditional claim.  Under the 
first set of claims, the European Communities alleged that the United States and Canada, by 
maintaining the suspension of concessions, were seeking redress of a perceived violation by the 
European Communities of the covered agreements w ithout recourse to the rules and procedures of the 
DSU, in breach of Article 23.2(a), read in c onjunction with Articles 21.5 and 23.1 of the DSU.600  
Under the second set of claims, the European  Communities submitted that, because it should be 
presumed  to have complied in good faith with the DS B's recommendations and rulings by adopting 
and notifying Directive 2003/74/EC, the continued a pplication of the suspension of concessions by 
the United States and Canada is also inconsistent w ith Article 23.1, read together with Articles 22.8 
and 3.7 of the DSU.601  Finally, in the event that the Panel was not to find "any violation under 
Articles 23.1, 23.2(a), 3.7, 22.8, and 21.5 of the DSU"602, the European Communities raised a 
conditional claim alleging that the United States a nd Canada violated Article 22.8 of the DSU  per se  
because, by adopting Directive 2003/74/EC, the European Communities had achieved  actual  (rather 
than  presumed ) compliance requiring termination of the su spension of concession in accordance with 
Article 22.8.603  
272. The Panel considered that this approach, alt hough not specified in the European Communities' 
request for the establishment of a panel, "is actually a clarification of the claims listed in its request 
                                                      
598Panel Report, US – Continued Suspension , para. 3.2;  Panel Report, Canada – Continued 
Suspension , para. 3.2. 
599Panel Report, US – Continued Suspension , paras. 7.150 and 7.151;  Panel Report, Canada – 
Continued Suspension , paras. 7.137 and 7.138. 
600Panel Report, US – Continued Suspension , paras. 7.153 and 7.183;  Panel Report, Canada – 
Continued Suspension , paras. 7.140 and 7.165. 
601Panel Report, US – Continued Suspension , paras. 7.153 and 7.252;  Panel Report, Canada – 
Continued Suspension , paras. 7.140 and 7.245.  
602Panel Report, US – Continued Suspension , para. 7.155;  Panel Report, Canada – Continued 
Suspension , para. 7.142. 
603Panel Report, US – Continued Suspension , para. 7.156;  Panel Report, Canada – Continued 
Suspension , para. 7.143. WT/DS321/AB/R 
Page 114  
 
for the establishment of a panel and not arguments".
604  Thus, the Panel considered that the approach 
outlined in the European Communities' first written s ubmission constituted part of the Panel's terms of 
reference.605  The Panel therefore decided that it would address the two main claims as elaborated by 
the European Communities in its first written su bmission, and would address the conditional claim 
only if the European Communities failed to establish its two main claims.606 
2. The European Communities' Claim th at the United States and Canada 
Breached Article 23.2(a) of the DSU Read Together with Articles 23.1 
and 21.5  
273. The Panel first examined the European Co mmunities' claim under Article 23.2(a), read 
together with Articles 23.1 and 21.5 of the DSU.  The Panel referred to the phrase "[i]n such cases", 
which connects paragraphs 1 and 2 of Article 23, a nd observed that this phrase indicated that it would 
have to determine whether the conditions of Artic le 23.1 were met before it could assess whether the 
United States and Canada breached Article 23.2(a) of  the DSU.  In the Panel's view, "Article 23.1 
applies in this case only with respect to a determ ination against a measure which has not yet been 
subject to a recourse to the rules and procedures of the DSU."607  According to the Panel, 
Directive 2003/74/EC is such a measure.608  Noting that Directive 2003/74/EC, like the measure it 
replaced, imposed an import ban, the Panel recalled that it is not the import ban on meat treated with 
hormones, but rather the justification for this ba n, that was found to be inconsistent with the  SPS 
Agreement  in  EC – Hormones .  Therefore, the Panel "d[id] not c onsider that the fact that the ban 
remains in place means that no new measure has been adopted".609  The Panel further found that, 
although the United States and Canada were authori zed to suspend concessions, such "'authorization 
by the DSB' does not mean [an] ' obligation to suspend concessions'."610  Thus, in the Panel's view, 
"the fact that, after the European Communities'  notification of Directive 2003/74/EC", the United 
States and Canada "continue[] to apply [their] su spension of concessions even though [they have] no 
                                                      
604Panel Report, US – Continued Suspension , para. 7.163;  Panel Report, Canada – Continued 
Suspension , para. 7.150. 
605Panel Report, US – Continued Suspension , para. 7.164;  Panel Report, Canada – Continued 
Suspension , para. 7.151. 
606Panel Report, US – Continued Suspension , para. 7.164;  Panel Report, Canada – Continued 
Suspension , para. 7.151. 
607Panel Report, US – Continued Suspension , para. 7.205;  Panel Report, Canada – Continued 
Suspension , para. 7.197. 
608Panel Report, US – Continued Suspension , para. 7.206;  Panel Report, Canada – Continued 
Suspension , para. 7.198. 
609Panel Report, US – Continued Suspension , para. 7.207;  Panel Report, Canada – Continued 
Suspension , para. 7.199. 
610Panel Report, US – Continued Suspension , para. 7.209;  Panel Report, Canada – Continued 
Suspension , para. 7.201.  WT/DS321/AB/R 
 Page 115 
 
 
obligation to do so is evidence" that the United Stat es and Canada are "actively" seeking the redress of 
a violation within the meaning of Article 23.1.611   
274. Having found that the conditions for the appli cability of Article 23.1 were met, the Panel 
proceeded to examine whether the United States and Canada had "ma[d]e a determination to the effect 
that a violation has occurred" within the meaning of Article 23.2(a) in respect of 
Directive 2003/74/EC.  The Panel observed that statem ents made at two DSB meetings concerning the 
notification of Directive 2003/74/EC indicated that the United States and Canada reached "a more or 
less final decision"612 that the new Directive fails to implement the DSB's recommendations and 
rulings in EC – Hormones  and is inconsistent with the  SPS Agreement .  Such statements, in the 
Panel's view, constitute a "determinati on" under Article 23.2(a) of the DSU.613  The Panel added that, 
even if such statements were considered provision al, "the subsequent continuation of the suspension 
of concessions by [the United States and Canada] w ithout alteration and without saying that [they 
were] still studying [Directive 2003/74/EC]" confirms  that they made such a "determination".614  The 
Panel further found that, because the DSB's author ization to suspend concessions does not apply to 
Directive 2003/74/EC615 and does not amount to "a multilatera l determination of  inconsistency" 
regarding that Directive616, the United States and Canada failed to make a determination through 
recourse to the rules and procedures of the DSU, in violation of Article 23.2(a) of the DSU.  Because 
the United States and Canada "ha[d] not made any determination through recourse to dispute 
settlement in accordance with th e rules and procedures of the DSU," the Panel concluded  a fortiori  
that the United States and Canada "ha[d] failed to  make any such determinat ion consistent with the 
findings contained in the panel or Appellate Body re port adopted by the DSB or an arbitration award 
rendered under the DSU."617  Therefore, the Panel found that the United States and Canada had 
breached Article 23.2(a) of the DSU.618 
                                                      
611Panel Report, US – Continued Suspension , para. 7.209;  Panel Report, Canada – Continued 
Suspension , para. 7.201. 
612Panel Report, US – Continued Suspension , para. 7.222;  Panel Report, Canada – Continued 
Suspension , para. 7.215 (quoting Panel Report, US – Section 301 Trade Act , footnote 657 to para. 7.50). 
613Panel Report, US – Continued Suspension , paras. 7.225 and 7.226;  Panel Report, Canada – 
Continued Suspension , paras. 7.219, 7.222, and 7.223. 
614Panel Report, US – Continued Suspension , para. 7.230;  Panel Report, Canada – Continued 
Suspension , para. 7.224. 
615Panel Report, US – Continued Suspension , para. 7.234;  Panel Report, Canada – Continued 
Suspension , para. 7.228. 
616Panel Report, US – Continued Suspension , para. 7.242;  Panel Report, Canada – Continued 
Suspension , para. 7.235. 
617Panel Report, US – Continued Suspension , para. 7.244;  Panel Report, Canada – Continued 
Suspension , para. 7.237. (emphasis omitted) 
618Panel Report, US – Continued Suspension , para. 7.245;  Panel Report, Canada – Continued 
Suspension , para. 7.238. WT/DS321/AB/R 
Page 116  
 
275. Next, the Panel turned to the European Commun ities' claim that the United States and Canada 
were required to initiate Article 21.5 proceedings if they considered that Directive 2003/74/EC was 
not consistent with the covered agre ements.  The Panel stated that recourse to the rules and procedures 
of the DSU, within the meaning of Article 23.2(a), "encompasses any of the means of dispute settlement provided in the DSU, including cons ultation, conciliation, goo d offices and mediation"
619 
and is not limited to panel proceedi ngs under Article 21.5 of the DSU.  On this basis, the Panel "[did] 
not find it necessary to make a finding on wh ether [the United States and Canada] breached 
Article 21.5 by not having recourse to the procedure under that provision".620 
276. On the basis of the above, the Panel conc luded that the United States and Canada: 
violated Article 23.1 and 23.2(a) of the DSU by seeking redress of a 
violation of the WTO Agreement through a determination that the 
[European Communities'] implementing measure did not comply with the DSB recommendations and rulings in the EC – Hormones  
case without having recourse to di spute settlement in accordance 
with the rules and procedures of the DSU.
621 
3. The European Communities' Claim th at the United States and Canada 
Breached Article 23.1 of the DSU Read Together with Articles 22.8 and 3.7  
277. The Panel then turned to the European Commun ities' claim that the United States and Canada 
breached Article 23.1, read together with Artic les 22.8 and 3.7 of the DSU, by continuing the 
suspension of concession even though the measure found to be  inconsistent in EC – Hormones  had 
been removed.  The Panel observed that its ear lier findings that the United States and Canada 
committed a "procedural error under the DSU [and] breached Articles 23.1 and 23.2(a)"622 were 
"completely unrelated to whether the European  Communities implemented the DSB recommendations 
and rulings"623 in EC – Hormones in substance.  In contrast, the Panel found that the European 
Communities' allegation of violati ons of Articles 22.8, 23.1, and 3. 7 of the DSU was premised on the 
"conformity  (presumed or actual) with the  SPS Agreement "624 of Directive 2003/74/EC.  This is 
because, in the Panel's view, the phrase "until such time as the measure found to be inconsistent ... has
                                                      
619Panel Report, US – Continued Suspension , para. 7.247;  Panel Report, Canada – Continued 
Suspension , para. 7.240. 
620Panel Report, US – Continued Suspension , para. 7.249;  Panel Report, Canada – Continued 
Suspension , para. 7.242. 
621Panel Report, US – Continued Suspension , para. 7.251;  Panel Report, Canada – Continued 
Suspension , para. 7.244. 
622Panel Report, US – Continued Suspension , para. 7.270;  Panel Report, Canada – Continued 
Suspension , para. 7.286. 
623Panel Report, US – Continued Suspension , para. 7.272;  Panel Report, Canada – Continued 
Suspension , para. 7.288. 
624Panel Report, US – Continued Suspension , para. 7.272;  Panel Report, Canada – Continued 
Suspension , para. 7.288.  WT/DS321/AB/R 
 Page 117 
 
 
been removed" in Article 22.8 implies that what is  to be achieved is not the removal of the measure, 
but actual compliance with the DSB's recommendations and rulings.625  Thus, Article 22.8 may be 
breached "only if the European Communities has complied with the recommendations and rulings of 
the DSB and [the United States and Canada] failed  to immediately remove [their] suspension of 
concessions or other obligations."626 
278. With respect to the Europ ean Communities' argument that it should benefit from "a 
presumption of good faith compliance"627 regarding Directive 2003/74/EC, the Panel acknowledged 
that, under general international law, States enjoy a presumption of good faith in the performance of their treaty obligations.
628  Nevertheless, the Panel found that th is presumption does not mean that the 
European Communities "actually complied with its treaty obligations"629 and additionally observed 
that the United States and Canada may also invoke the presumption of good faith with regard to their 
respective measures.630  Turning to the text of the DSU, the Panel found that "there is no express 
exclusion of the application of the principle of good faith in the DSU".631  The Panel then rejected the 
United States' and Canada's argument that "the presumption of good faith compliance cannot 
supersede the multilateral authorization of the DSB ... to suspend concessions."632  According to the 
Panel, "the removal of the measure found to be in consistent with a covere d agreement supersedes the 
DSB authorization to suspend concessions", because not hing in Article 22.8 of the DSU suggests that 
a Member suspending concessions can continue to do so as long as the aut horization has not been 
repealed by the DSB.633   
279. Next, the Panel examined the European Comm unities' argument that the presumption of good 
faith compliance is only rebuttable by recourse to Article 21.5 by the United States and Canada.  In 
examining this argument, the Panel considered it important "to determine the extent to which the 
                                                      
625Panel Report, US – Continued Suspension , para. 7.284;  Panel Report, Canada – Continued 
Suspension , para. 7.300. 
626Panel Report, US – Continued Suspension , para. 7.285;  Panel Report, Canada – Continued 
Suspension , para. 7.301. 
627Panel Report, US – Continued Suspension , para. 7.310;  Panel Report, Canada – Continued 
Suspension , para. 7.310. 
628Panel Report, US – Continued Suspension , para. 7.318;  Panel Report, Canada – Continued 
Suspension , para. 7.318. 
629Panel Report, US – Continued Suspension , para. 7.322;  Panel Report, Canada – Continued 
Suspension , para. 7.322.  
630Panel Report, US – Continued Suspension , para. 7.323;  Panel Report, Canada – Continued 
Suspension , para. 7.323. 
631Panel Report, US – Continued Suspension , para. 7.336;  Panel Report, Canada – Continued 
Suspension , para. 7.336. 
632Panel Report, US – Continued Suspension , para. 7.342;  Panel Report, Canada – Continued 
Suspension , para. 7.342. 
633Panel Report, US – Continued Suspension , para. 7.343;  Panel Report, Canada – Continued 
Suspension , para. 7.343. WT/DS321/AB/R 
Page 118  
 
unavailability of any legal recourse for the Europ ean Communities in a post retaliation situation may 
justify that the presumption of good faith compliance be irrebuttable, except through recourse to the 
procedure provided in Article 21.5 of the DSU."
634  The Panel noted, first, that "nowhere does the 
DSU provide that a presumption of good faith comp liance should be rebuttable only through recourse 
to Article 21.5 of the DSU."635  Secondly, the Panel observed that "it appears that, even under the 
current DSU, several means seem  a priori  to be available to the European Communities to obtain 
termination of the suspension of concessions or  other obligations", including good offices and 
consultations, Article 21.5 proceedings, arbitrati on under Article 25 of the DSU, and recourse to 
regular panel procedures (as the European Communities had done in the present case).636  For these 
reasons, the Panel rejected the European Commun ities' argument "that the presumption of good faith 
compliance which the European Communities enjoys  should be rebuttable only through a recourse by 
the complainants in the original  case to Article 21.5 of the DSU."637  The Panel was not persuaded that 
Article 21.5 is the "only avenue" for addressing "a cl aim of compliance by a Member alleging to have 
complied with DSB recommendations and rulings", nor that Article 21.5 proceedings are "open only 
to the original complainant".638 
280. The Panel concluded: 
while we agree with the existence of a presumption of good faith 
compliance, we do not agree with the European Communities that the 
presumption of good faith that it enjoys may only be rebutted in an 
Article 21.5 procedure.  We find, on the contrary, that this presumption, because it applies to measures taken by all parties, must be rebuttable before this Panel.  Just as the [Eur opean Communities'] 
allegations are intended to re but the presumption of good faith 
conformity of the [United States and Canadian] retaliatory measures 
with Article 22.8 of the DSU, [the United States and Canada] should 
                                                     
 
634Panel Report, US – Continued Suspension , para. 7.348;  Panel Report, Canada – Continued 
Suspension , para. 7.346. 
635Panel Report, US – Continued Suspension , para. 7.349;  Panel Report, Canada – Continued 
Suspension , para. 7.347. 
636Panel Report, US – Continued Suspension , para. 7.350;  Panel Report, Canada – Continued 
Suspension , para. 7.348.  The Panel noted that the broad language ("such dispute shall be decided through 
recourse to these dispute settlement procedures") used in Article 21.5 "could be deemed to encompass any 
procedure available under the DSU for the resolution of disputes".  The Panel, however, opined that "other 
terms in Article 21.5 support the view that the Article 21 .5 procedure is actually a panel procedure with a shorter 
deadline" and read the phrase "including whenever possible resort to the original panel" not as meaning that 
resort to a panel is generally preferred, but as requesting resort to the panelists that served on the original case, 
rather than to other individuals.  (Panel Report, US – Continued Suspension , para. 7.351;  Panel Report, 
Canada – Continued Suspension , para. 7.349) 
637Panel Report, US – Continued Suspension , para. 7.356;  Panel Report, Canada – Continued 
Suspension , para. 7.354. 
638Panel Report, US – Continued Suspension , para. 7.355;  Panel Report, Canada – Continued 
Suspension , para. 7.353.  WT/DS321/AB/R 
 Page 119 
 
 
be allowed to rebut the presumption of [European Communities'] compliance by proving actual non-compliance.
639 
281. The Panel noted that, by invoking a presumption of good faith compliance, the European 
Communities was supporting its claim th at the United States and Cana da acted inconsistently with 
Article 23.1, read together with Articles 22.8 and 3. 7, because they failed to  terminate the suspension 
of concessions upon the removal of the measure found to be inconsistent w ith a covered agreement 
within the meaning of Article 22.8.640  Thus, having determined that the presumption of good faith 
compliance is rebuttable in these proceedings, the Panel observed that, "for all practical purposes, this amounts to addressing the [European Communities'] 'alternative' claim of violation of Article 22.8  per se ."
641  The Panel, however, explained that "this is not the result of us merely 
disregarding the order in which the European Communities wanted us to review this case".642  Rather, 
the Panel considered that it was "still reviewing th e [European Communities'] claim of violation of 
Article 23.1, read together with Articles 22.8 and 3.7" and "not reviewing a claim of violation of 
Article 22.8 in isolation."643 
4. The Panel's Jurisdiction  
282. The Panel recognized that its "terms of refe rence do not include any provision of the  SPS 
Agreement "644 and that, as a consequence, it was not within its mandate to review the alleged 
violations of the  SPS Agreement  or to make findings under that Agreement.  Nonetheless, the Panel 
found that it "should address the compatibility of [Directive 2003/74/EC] with the provisions of the SPS Agreement  referred to by the parties to the extent necessary to determine, with respect to the 
                                                     
 
639Panel Report, US – Continued Suspension , para. 7.357(f);  Panel Report, Canada – Continued 
Suspension , para. 7.355(f).  The Panel clarified: 
In reaching these conclusions, we do not consider that we add to or diminish the rights and obligations of WTO Members.  We do not apply the 
presumption of good faith compliance independently from the obligations of 
the European Communities under th e WTO Agreement. The European 
Communities has an obligation to comply with the WTO Agreement in 
general and with the recommendations and rulings of the DSB and the general 
principle of good faith implies that the European Communities do so in good faith.  In doing so we apply the principle of good faith consistently with WTO 
law and general public international law. 
(Panel Report, US – Continued Suspension , para. 7.358;  Panel Report, Canada – Continued Suspension , 
para. 7.356) (footnotes omitted) 
640Panel Report, US – Continued Suspension , para. 7.332;  Panel Report, Canada – Continued 
Suspension , para. 7.332. 
641Panel Report, US – Continued Suspension , para. 7.359;  Panel Report, Canada – Continued 
Suspension , para. 7.357. 
642Panel Report, US – Continued Suspension , para. 7.359;  Panel Report, Canada – Continued 
Suspension , para. 7.357. 
643Panel Report, US – Continued Suspension , para. 7.359;  Panel Report, Canada – Continued 
Suspension , para. 7.357. 
644Panel Report, US – Continued Suspension , para. 7.360;  Panel Report, Canada – Continued 
Suspension , para. 7.358. WT/DS321/AB/R 
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[European Communities'] claim relating to Artic le 22.8, whether the [European Communities'] 
measure found to be inconsistent in the  EC – Hormones  case has been removed."
645  Therefore, the 
Panel considered "that these are sufficient reasons for it to conclude that it has jurisdiction to consider 
the compatibility of the [European Comm unities'] implementing measure with the  SPS Agreement  as 
part of its review of the claim raised by the Eur opean Communities with respect to Article 22.8 of the 
DSU."646  The Panel recognized that it was difficult fo r the European Communities to "identify all 
potential problems of incompatibility".647  Instead, the Panel considered it "preferable, both from a 
legal and practical point of view, to consider  all  the allegations and arguments raised by each party, 
as long as the other party had the opportunity to  comment on those allegations and arguments".648  On 
this basis, the Panel found that it could review  the compatibility of the Directive 2003/74/EC with 
Articles 5.1, 5.2649, 5.7, and 3.3 of the  SPS Agreement . 650 
5. Burden of Proof  
283. Regarding the allocation of burden of proof, th e Panel stated that it was for the European 
Communities to prove its claim that the United St ates and Canada had breached Article 22.8 of the 
DSU.651  This claim was premised on the removal by the European Communities of the measure that
                                                      
645Panel Report, US – Continued Suspension , para. 7.375;  Panel Report, Canada – Continued 
Suspension , para. 7.372.  The Panel was "mindful of the procedural problems raised by this approach", but did 
not consider that, by proceeding in this manner, it was ex ceeding its jurisdiction to the extent that such a review 
is necessary in order to address the Europe an Communities' claims under Article 22.8. ( Ibid.) 
646Panel Report, US – Continued Suspension , para. 7.379;  Panel Report, Canada – Continued 
Suspension , para. 7.376. 
647Panel Report, US – Continued Suspension , para. 7.403;  Panel Report, Canada – Continued 
Suspension , para. 7.400. 
648Panel Report, US – Continued Suspension , para. 7.404;  Panel Report, Canada – Continued 
Suspension , para. 7.401. (original emphasis) 
649The Panel reviewed Article 5.2 of the  SPS Agreement  in US – Continued Suspension  only, because 
Canada did not make a claim under this provision. 
650Panel Report, US – Continued Suspension , para. 7.411;  Panel Report, Canada – Continued 
Suspension , para. 7.402. 
651Panel Report, US – Continued Suspension , para. 7.383;  Panel Report, Canada – Continued 
Suspension , para. 7.380.  The Panel explained:  
With respect to the violation of Article 22.8 as such, the Panel considered that 
it had, in principle, no reason to address burden of proof any differently than 
any other panel established under Article 6 of the DSU.  Indeed, as stated by the [European Communities] itself, this case is about a measure taken by [the 
United States and Canada, respectively].  The fact that this dispute takes place 
in the context of the [European Comm unities'] alleged compliance with the 
recommendations and rulings of the DSB in the EC – Hormones  dispute 
should have no impact on the question of the burden of proof regarding the actual claim before us.  This means th at the principles identified by the 
Appellate Body above apply, and that the European Communities must prove 
its claim that [the United States and Canada] breach[] Article 22.8 of the DSU. 
(Panel Report, US – Continued Suspension , para. 7.383;  Panel Report, Canada – Continued Suspension , 
para. 7.380)  WT/DS321/AB/R 
 Page 121 
 
 
had been found to be inconsistent in  EC – Hormones  and on its allegation that Directive 2003/74/EC 
was consistent with the  SPS Agreement .  The Panel shared the European Communities' concern that 
this could generate for the original respondent at the beginning of the proceedings a situation 
"equivalent to having to 'prove a negative', since the spectrum of provisions against which the legality 
of the [European Communities'] measure may have to be reviewed remain[ed] very broad" as long as 
the original complainants had not made their own allegations of inconsiste ncy of the implementing 
measure.652  The Panel noted that the European Communities enjoyed a rebuttable presumption of 
good faith compliance and thus, once it had established a  prima facie  case on the basis of that 
presumption, the burden shifted to the United Stat es and Canada to rebut that presumption.  The 
Panel, however, considered that the United States and Canada "sufficiently refuted the [European 
Communities'] allegation of compliance"653 with the  SPS Agreement  and, subsequently, the 
European Communities responded to the allegations of violation.  Therefore, the Panel believed that 
the European Communities "never actually ha d to 'prove a negative' in this case."654  In the Panel's 
view, the "presumptions based on good faith enjoye d by each party ... eventually 'neutralized' each 
other" such that ultimately, each party had to prove  its specific allegations in  response to the evidence 
submitted by the other party and the Panel followed the practice of other panels to weigh all the 
evidence before it.655 
284. On this basis, the Panel went on to examine the consistency of Directive 2003/74/EC with the 
SPS Agreement , and found that "it has not been estab lished that the European Communities has 
removed the measure found to be inc onsistent with a covered agreement."656  Consequently, the Panel 
concluded that the European Communities failed to demonstrate a breach of Article 22.8 of the DSU by the United States and Canada and thus there wa s no violation of Articles 23.1 and 3.7 of the DSU 
as a result of a breach of Article 22.8.
657 
                                                      
652Panel Report, US – Continued Suspension , para. 7.385;  Panel Report, Canada – Continued 
Suspension , para. 7.382. 
653Panel Report, US – Continued Suspension , para. 7.385;  Panel Report, Canada – Continued 
Suspension , para. 7.382. 
654Panel Report, US – Continued Suspension , para. 7.385;  Panel Report, Canada – Continued 
Suspension , para. 7.382. 
655Panel Report, US – Continued Suspension , para. 7.386;  Panel Report, Canada – Continued 
Suspension , para. 7.383. 
656Panel Report, US – Continued Suspension , para. 7.847;  Panel Report, Canada – Continued 
Suspension , para. 7.832.  The Panel's analysis is summarized infra , in sections VI and VII. 
657Panel Report, US – Continued Suspension , paras. 7.850 and 7.851;  Panel Report, Canada – 
Continued Suspension , paras. 7.385 and 7.836.  Having found a violation of Articles 23.2(a) and 23.1 of the 
DSU and addressed the alleged violation of Article 22.8 as part of its review of the European Communities' 
second main claim, the Panel consider ed it unnecessary to address the Eu ropean Communities' conditional claim 
of violation of Article 22.8 of the DSU  per se  in the alternative. (Panel Report, US – Continued Suspension , 
paras. 7.855;  Panel Report, Canada – Continued Suspension , para. 7.840) WT/DS321/AB/R 
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6. The Panel's Suggestion
 
285. After setting out its conclusions, the Panel observe d that the parties had "apparently diverging 
opinions as to how this report should be implemented by the respondent".658  The Panel then noted 
that, although it had "performed functions similar to  that of an Article 21.5 panel, this was done only 
in order to determine whether Article 22.8 of th e DSU had been breached" and that it "was not called 
upon, nor [did] it have jurisdiction, to determine the compatibility of Directive 2003/74/EC with the 
covered agreements".659  Thus, the Panel suggested that, "in order to implement its findings under 
Article 23 and in order to ensure the prompt settlement  of this dispute, [the United States and Canada] 
should have recourse to the rules and procedures of the DSU without delay."660 
C. Claims and Arguments on Appeal 
1. Appeal by the European Communities  
286. The European Communities raises three claims of error on appeal.  First, the European 
Communities submits that the Panel erred by failing to  find that Article 23.2(a), read together with 
Articles 21.5 and 23.1 of the DSU, required the United States and Canada to initiate Article 21.5 
proceedings if they considered that Directiv e 2003/74/EC did not bring the European Communities 
into compliance with the DSB's recommendations and rulings in  EC – Hormones .661  The European 
Communities maintains that recourse to procedures unde r Article 21.5 is required  in order to examine 
the consistency of Directive 2003/74/EC with the  SPS Agreement , and Article 21.5 proceedings may 
only be initiated by the original complainan ts, in this case, the United States and Canada.662  
Secondly, the European Communities asserts that Article 22.8 required the termination of the 
suspension of concessions upon the adoption and the subsequent notification of Directive 2003/74/EC 
to the DSB.663  Thus, the European Communities considers that the Panel erred in finding that its 
claim under Article 23.1, read together with Artic les 22.8 and 3.7 of the DSU, was premised on the 
actual conformity of Directive 2003/74/EC with the  SPS Agreement664;  as a result, the Panel also 
erred in finding that the United States and Canada did not breach Article 22.8 of the DSU, even 
though they continued to suspend concessions without having recourse to Article 21.5.  Thirdly, the 
                                                      
658Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3. 
659Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3. 
660Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3. 
661European Communities' appellant's submission, para. 94. 
662Ibid., paras. 49 and 73. 
663Ibid., para. 155. 
664Ibid., paras. 99 and 100 (referring to Panel Report, US – Continued Suspension , para. 7.272;  and 
Panel Report, Canada – Continued Suspension , para. 7.288).  WT/DS321/AB/R 
 Page 123 
 
 
European Communities alleges that  the Panel went beyond its terms of reference and erroneously 
assumed the functions of an Article 21.5 panel by examining the compatibility of 
Directive 2003/74/EC with the  SPS Agreement .665  In addition to these three claims of error, the 
European Communities requests the Appellate Body to "improve"666 the Panel's suggestion that the 
United States and Canada "should have recourse to the rules and procedures of the DSU without 
delay"667, so as to make it clear that the United States and Canada must cease applying their 
suspension of concessions and have recourse to Artic le 21.5 of the DSU, or other dispute settlement 
proceedings to which the parties may agree, in or der to seek multilateral resolution of any remaining 
disagreements over the European Communities' import ban.668 
287. The United States maintains that the Panel correctly interpreted the phrase "recourse to 
dispute settlement in accordance with the rules and procedures of this Understanding" in 
Article 23.2(a) as encompassing all procedures under the DSU, rather than relating exclusively to 
Article 21.5 panel proceedings.669  The United States further submits that Article 21.5 refers to "these 
dispute settlement procedures" without specifying any particular subset of the procedures provided in 
the DSU.670  In addition, the United States argues that th e Panel correctly interpreted Article 22.8 of 
the DSU when finding that the United States did not  breach its obligation under that provision.  The 
United States asserts that the European Comm unities "simply switched" the legal instruments 
underlying the import ban and, in so doing, failed to remove the ban, that is, the inconsistent measure 
within the meaning of Article 22.8.671  The United States further claims that the European 
Communities specifically asked the Panel to review whether the United States acted inconsistently 
with Article 22.8.  Thus, in order to adjudicate that  claim, the Panel correctly interpreted and applied 
Article 22.8 by examining the consiste ncy of Directive 2003/74/EC with the  SPS Agreement  and did 
not exceed its terms of reference.672  Moreover, the United States ar gues that the Panel's suggestion 
does not require it to terminate the suspension of co ncessions.  Finally, the United States observes that 
"improving" the suggestion, as requested by the Euro pean Communities, "is not within the purview of 
what the Appellate Body is called upon to do with respect to panel reports".673 
                                                      
665European Communities' appellant's submission, para. 175. 
666Ibid., para. 479. 
667Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3. 
668European Communities' appellant's submission, para. 480. 
669United States' appellee's submission, para. 126. 
670Ibid., para. 127. 
671Ibid., para. 99. 
672Ibid., paras. 120 and 121. 
673Ibid., para. 140.  The United States points out that "the Appellate Body, under Article 17.13, 'may 
uphold, modify, or reverse the legal findings and conclusions of the panel', but not its suggestions, which are 
made pursuant to Article 19.1 of the DSU." WT/DS321/AB/R 
Page 124  
 
288. Canada submits that, contrary to the European  Communities' contentions, the Panel correctly 
found that "recourse to dispute settlement" within th e meaning of Article 23.2(a) is not limited to 
Article 21.5 panel proceedings.  Canada mainta ins that the European Communities' unilateral 
assertion of compliance regarding Directive 2003/ 74/EC does not compel Canada to initiate 
Article 21.5 proceedings, and does not require Ca nada to lift the suspension of concessions.
674  
Canada alleges that the European Communities, as  the original respondent, is not legally precluded 
from initiating Article 21.5 proceedings675, and that other procedural avenues are also available to the 
European Communities, including new panel proceedings.676  Canada further claims that the Panel 
correctly interpreted Article 22.8 by concluding th at the phrase "until such time as the measure found 
to be inconsistent with a covered agreement has be en removed" means that the inconsistency itself, 
and not only the originally impugned measure, has been removed.677  Finally, Canada maintains that 
the Panel did not exceed its terms of reference in  examining the consistency of Directive 2003/74/EC 
with the  SPS Agreement .  Rather, Canada asserts that, because the European Communities' claim that 
Canada breached Article 22.8 is premised on act ual compliance by the European Communities, the 
Panel was required to review the consis tency of Directive 2003/74/EC with the  SPS Agreement  to 
resolve the dispute.678 
2. Other Appeals by the United States and Canada  
289.   The United States claims that the Panel erre d in finding that the United States was "seeking 
the redress of a violation" within the meaning of  Article 23.1 of the DSU through the continued 
suspension of concessions.  The United States maintain s that it "had extensive and lengthy recourse to 
multiple procedures under the DSU"679 before obtaining the authorization of the DSB to suspend 
concessions on 26 July 1999, and this authoriza tion to suspend concessions has never been revoked.680  
By finding that the United States was seeking the redress of a violation, the Panel "re-characteriz[ed]"
681, without any legal basis, the United Stat es' suspension of concessions as directed 
against Directive 2003/74/EC.  Furthermore, the Unite d States takes issue with the Panel's finding that 
the United States' statements regarding Dir ective 2003/74/EC at DSB meetings constituted a 
"determination" within the meaning of Article 23.2( a) of the DSU.  The United States maintains that 
such a "determination" cannot be inferred or imp lied, and the Panel erred in drawing such an 
                                                      
674Canada's appellee's submission, para. 8. 
675Ibid., para. 11. 
676Ibid., paras. 14 and 15. 
677Ibid., paras. 25 and 26. 
678Ibid., para. 41. 
679United States' other appellant's submission, para. 29. 
680Ibid., para. 18. 
681Ibid., para. 31.  WT/DS321/AB/R 
 Page 125 
 
 
inference from the United States' "inaction"682 regarding the suspension of  concessions.  In the event 
that the Appellate Body upholds the Panel's findi ngs under Articles 23.2(a) and 23.1, the United 
States requests reversal of th e Panel's "erroneous suggestion"683 that the United States "must have 
recourse to the rules and procedures of the DSU w ithout delay".  The United States contends that 
"recourse to the rules and procedures" of the DSU has already been achieved by the United States' 
participation in this dispute initiated by the European Communities.684  The United States further 
submits that the Panel erred in concluding that it had no jurisdiction to rule on the compatibility of 
Directive 2003/74/EC with the  SPS Agreement .  Consequently, the Panel's findings regarding the 
inconsistency of Directive 2003/74/EC with the  SPS Agreement  should be considered "direct" 
findings and the conclusion that the United States ne eds to bring its measure into conformity with the 
DSU should be reversed.685 
290. Canada alleges that the Panel erred by exam ining the European Communities' claim under 
Articles 23.2(a) and 23.1 in isolation from its anal ysis under Article 22.8 of the DSU.  According to 
Canada, the Panel should have firs t applied the requirements of Artic le 22.8 to determine whether the 
suspension of concessions had to be terminated, and the Panel's failure to do so resulted in 
"contradictory findings"686 concerning the first and second set s of claims of the European 
Communities.  Canada conditionally appeals two othe r issues, in case the Appellate Body were to find 
that the Panel was correct in making findings in respect of Articles 23.1 and 23.2(a) without taking 
into account its finding in respect of Article 22.8.  Fi rst, Canada contends that, even if the Panel were 
correct to consider Article 23 in isolation, the Panel erred in finding that  Canada was "seeking the 
redress" of a WTO violation by continuing the susp ension of concessions.  Canada maintains that it 
has "sought and obtained"687 the DSB's authorization to suspend concessions and that, contrary to the 
Panel's finding, simply because Directive 2003/74/EC is a new measure does not imply that the legal 
basis for Canada's suspension of concessions has changed.688  Secondly, Canada alleges that the Panel 
erred in finding that Canada made a unilate ral determination of non-compliance regarding 
Directive 2003/74/EC, within the meaning of Article 23. 2(a), on the basis of Canada's statements at 
the DSB meetings, as well as the fact that Canada continued to suspend concessions.689  I n  t h e  
alternative, should the Appellate Body uphold the Panel's findings under Articles 23.2(a) and 23.1, 
                                                      
682United States' other appellant's submission, para. 98. 
683Ibid., para. 108. 
684Ibid., para. 112. 
685Ibid., para. 119.  The United States clarifies that th e Appellate Body need not address these last two 
points should it reverse the Panel's findings and conclusions concerning Articles 23.1 and 23.2(a) of the DSU.  
(Ibid., para. 9) 
686Canada's other appellant's submission, para. 43. 
687Ibid., para. 80. 
688Ibid., para. 82. 
689Ibid., para. 87. WT/DS321/AB/R 
Page 126  
 
Canada requests the Appellate Body to reverse the Panel's conclusion that it did not have jurisdiction 
to determine the compatibility of Directive 2003/74/EC with the  SPS Agreement .
690  Finally, Canada 
claims that the Panel erred in making the suggesti on that "Canada should have recourse to the rules 
and procedures of the DSU without delay"691 because this conclusion, according to Canada, 
contradicts the Panel's own finding that  Canada had not breached Article 22.8.692 
291. The European Communities responds that Article 23 of the DSU is fully applicable in the 
implementation and post-suspension stage of a dispute693, because the multilateral dispute settlement 
system relies on good faith compliance and the pr esumption of conformity with the covered 
agreements of measures taken by WTO Members.694  The European Communities further contends 
that the adoption of a measure taken to comply, wh ich must be presumed to be consistent with the 
WTO agreements, triggers the following duties on the original complainant:  (i) to form a view on 
whether the measure that has been found to be inconsis tent has been removed;  (ii) to have recourse to 
Article 21.5 proceedings if it considers that the meas ure taken to comply is not consistent with the 
covered agreements;  and (iii) to cease the suspension of concessions.695  The European Communities 
disagrees with the argument of the United States and Canada that they are not seeking the redress of a 
violation within the meaning of Article 23.1 by maintaining the suspensi on of concessions, because 
the notification of Directive 2003/74/EC does not change the legal basis for the suspension of 
concessions.696  The European Communities submits that Article 22.8 of the DSU does not specify 
that it is for the original respondent to s how that it has removed the original measure697, and that, in 
any event, the European Communitie s has effectively shown that the inconsistent measure, namely 
Directive 96/22/EC, has been removed.698  Thus, the United States and Canada could no longer 
maintain their suspension of concessions once the European Co mmunities had adopted 
Directive 2003/74/EC.699   
292. The European Communities furt her argues that the Panel co rrectly found that the United 
States and Canada made a determination to the effect  that a violation has occurred within the meaning 
of Article 23.2(a) of the DSU.  The European Communities maintains that the statements by the 
United States and Canada at the DSB meetings, t ogether with the fact that the United States and 
Canada have maintained their suspension of c oncessions, indicate that they made a "definitive" 
                                                      
690Canada's other appellant's submission, para. 92. 
691Ibid., para. 96. 
692Ibid., para. 95. 
693European Communities' appellee's submission, para. 47. 
694Ibid., para. 40. 
695Ibid., para. 62. 
696Ibid., paras. 103, 104, and 113. 
697Ibid., para. 114. 
698Ibid., para. 115. 
699Ibid., paras. 105 and 115.  WT/DS321/AB/R 
 Page 127 
 
 
determination with sufficient "firmness or im mutability" regarding the inconsistency of 
Directive 2003/74/EC with the covered agreements.700  Furthermore, the European Communities 
disagrees with the United States' view that the Pane l inferred the existence of a "determination" from 
inaction.  According to the Eur opean Communities, the United Stat es "actively considered" that 
Directive 2003/74/EC is not consistent with the co vered agreements and "actively continued" the 
suspension of concessions.701   
3. Arguments of the Third Participants  
293. Australia agrees with the European Commun ities that the disagreement as to whether 
Directive 2003/74/EC has removed the measure found to  be inconsistent with the WTO agreements 
should have been resolved through recour se to panel proceedings under Article 21.5.702  However, 
Australia believes that it is open to a Member to continue the suspension of concessions pending the outcome of the Article 21.5 panel proceedings.
703  Finally, Australia underscores that no provision of 
the  SPS Agreement  is included in the Panel's terms of reference, and that  to include claims under the 
SPS Agreement  within the scope of this dispute effectivel y reverses the burden of proof between the 
parties.  This "is inconsistent with a fundament al principle ... that the party asserting non-compliance 
with a covered agreement bears the burden of establishing a  prima facie  case."704 
294. Brazil contends that none of the three cond itions set out in Article 22.8 regarding the 
termination of the suspension of concessions has be en fulfilled, and thus the DSB's authorization 
granted to the United States and Canada to suspend concessions remains in place.705  Brazil agrees 
with the Panel that the removal of the measure found to be inconsistent, within the meaning of 
Article 22.8, must be interpreted as requiring subs tantive compliance.  Furthermore, Brazil asserts 
that, in the post-suspension stage of a dispute, the original responding Member bears the burden of 
proving that its implementing measure is WTO-consistent.706   
295. New Zealand submits that the Panel failed to in terpret Articles 23.1 and 23.2(a) in the context 
of Article 22.8 of the DSU.  According to New Zeal and, Article 22.8 refers to situations where the 
original inconsistent measure has actually been removed, and not where the measure is merely 
claimed to have been removed.707  Therefore, New Zealand considers that the Panel erred in finding
                                                      
700European Communities' appellee's submission, paras. 126 and 136-138. 
701Ibid., para. 133. 
702Australia's third participant's submission, para. 15. 
703Ibid., para. 21. 
704Ibid., para. 25. 
705Brazil's third participant' s submission, para. 10. 
706Ibid., para. 33. 
707New Zealand's third participant's submission, para. 3.17. WT/DS321/AB/R 
Page 128  
 
that the European Communities' claims under Articl es 23.1 and 23.2(a) were completely unrelated to 
whether the European Communities had implemented the DSB's recommendations and rulings in 
EC – Hormones .
708 
296. Norway maintains that Article 22.8 requires that the suspension of concessions be temporary 
and conditional.  Thus, once compliance is achieve d, be it through a simple revocation of the 
inconsistent measure or its repla cement with another measure that ensures compliance, the right to 
suspend concessions " automatically  lapses"709 without a need for formal revocation of the 
authorization by the DSB.  Where the parties disag ree as to whether the measure taken to comply 
actually achieves compliance, as is the case in this dispute, both the original complainant and the 
original respondent can resort to Article 21.5 panel proceedings.710 
D. Cessation of the Suspension of Concessions – Article 22.8 of the DSU 
1. Preliminary Comments  
297. The European Communities alleges that the Panel erred by failing to find that Article 23.2(a), 
read together with Articles 21.5 and 23.1 of th e DSU, required the United States and Canada to 
initiate Article 21.5 proceedings if they consid ered that Directive 2003/74/EC did not bring the 
European Communities into compliance with the DSB's recommendations and rulings in EC – 
Hormones .711  The European Communities further asserts  that the Panel erred in finding that 
Article 22.8 of the DSU requires actual complianc e with the DSB's recommendations and rulings in 
EC – Hormones  before the suspension of c oncessions has to be terminated712, and that the Panel 
exceeded its terms of reference by examining such compliance when an alyzing the European 
Communities' claims under Articles 23.1, 22.8, and 3.7 of the DSU.713 
298. For the sake of simplicity, we refer to the Me mber applying the suspension of concessions 
pursuant to the DSB's authorization as the "suspend ing Member".  We refer to the Member against 
whom the suspension of concessions is applied as the "implementing Member". 
299. The European Communities' claims raise seve ral questions concerning the position of the 
suspending Member in circumstances where a measure is taken by the implementing Member to comply with the DSB's recommendations and ruli ngs.  The first question concerns whether the
                                                     
 
708New Zealand's third participant's submission, para. 3.18. 
709Norway's third participant's submission, para. 6. (original emphasis) 
710Ibid., para. 9. 
711European Communities' appellant's submission, para. 94. 
712Ibid., para. 152. 
713Ibid., para. 175.  WT/DS321/AB/R 
 Page 129 
 
 
suspending Member is required to initiate Artic le 21.5 proceedings, if it considers that the 
implementing measure fails to bring about complianc e.  The second question concerns the substantive 
issue as to whether an obligation to  lift the suspension of concessions, pursuant to Article 22.8, arises 
when an implementing measure replaces the impugned measure.  We recall that this dispute concerns 
the legality of the suspension of concessions maintain ed by the United States and Canada subsequent 
to the adoption and notification of the Eur opean Communities' implementing measure.  The 
suspension of concessions that is authorized by  the DSB must be applied consistently with 
Article 22.8 of the DSU.  Therefore, we first examine whether the Panel erred in finding that 
Article 22.8 requires actual compliance by the European Communities with the DSB's 
recommendations and rulings before the suspension of concessions must be terminated by the United 
States and Canada.  We will then turn, in section E,  to the issue of whether Article 21.5 proceedings 
are the proper procedures to follow and which party must initiate such proceedings.   
2. When Must a WTO Member Cease to Suspend Concessions Pursuant to 
Article 22.8 of the DSU?  
300. The European Communities submits that its clai ms under Article 23.1, read together with 
Articles 22.8 and 3.7 of the DSU, are based on its " interpretation  of Article 22.8, according to which 
the words 'the measure found to be inconsistent with a covered agreement'  refer to the measure 
identified in the recommendations of the DSB".714  The European Communities submits that the 
"measure found to be inconsistent  with a covered agreement" in EC – Hormones  was 
Directive 96/22/EC.715  The European Communities mainta ins that Directive 96/22/EC "was 
removed"716, within the meaning of Article 22.8, after being replaced by Directive 2003/74/EC.  Thus, 
by continuing the suspension of concessions, th e United States and Canada made a unilateral 
determination that Directive 2003/74/EC was not consistent with the  SPS Agreement , in violation of 
Article 23.1 "read in the light of Article 22.8".717  Therefore, the Europ ean Communities asserts that, 
contrary to the Panel's finding, it "never argued" th at the claim under Article 23.1, read together with 
Articles 22.8 and 3.7 of the DSU, was premised on a violation of Article 22.8 by the United States and Canada and "never argued" that this claim was premised on the conformity of the implementing 
measure with the  SPS Agreement .
718   
301. The European Communities' arguments are premis ed on its interpretation of Article 22.8 as 
requiring the termination of suspension of concessions  whenever an implementing measure is adopted 
                                                      
714European Communities' appellant's submission, para. 102. (original emphasis) 
715Ibid., para. 129. 
716Ibid., para. 146. 
717Ibid., para. 102. 
718Ibid., paras. 99 and 100 (referring to Panel Report, US – Continued Suspension , para. 7.272;  and 
Panel Report, Canada – Continued Suspension , para. 7.288). WT/DS321/AB/R 
Page 130  
 
to replace the measure found to be inconsistent in  proceedings that led to the DSB's recommendations 
and rulings.  According to this inte rpretation, termination is required irrespective of the content of the 
implementing measure.  Therefore, we proceed to examine the proper interpretation of Article 22.8 
and, in particular, the phrase "the measure found to be inconsistent with a c overed agreement has been 
removed" in that provision.  
302. Article 3.7 of the DSU states that "the first objective of the dispute settlement mechanism is 
usually to secure the withdrawal of the measures con cerned if these are found to be inconsistent with 
... the covered agreements."  If this cannot be ach ieved, the "last resort" provided under the DSU "to 
the Member invoking the dispute settlement pr ocedures is the possibility of suspending the 
application of concessions ... on a discriminatory basis vis-à-vis the other Member, subject to 
authorization by the DSB".  Acco rdingly, in the event that the DSB's recommendations and rulings 
are not implemented within a reasonable period of time, Article 22.1 provid es for the suspension of 
concessions as a "temporary measure" available to th e Member that originally initiated the dispute 
settlement procedures.
719 
303. The suspension of concessions may not be mainta ined indefinitely.  The authorization to 
suspend concessions is contingent and limited in time.  Article 22.8 of the DSU provides that the 
suspension of concessions shall be "temporary" a nd shall only be applied until one of the three 
resolutive conditions set out in that provision obtains, namely, when:  
... the measure found to be inconsis tent with a covered agreement has 
been removed, or the Member that must implement recommendations or rulings provides a solution to the nullification or impairment of benefits, or a mutually satisfactory solution is reached. 
304. The participants agree that this dispute concerns  the first condition listed in Article 22.8, that 
is, when "the measure found to be inconsistent with  a covered agreement has been removed".  In most 
cases, the first condition in Article 22.8 will be met where the implementing Member repeals the 
inconsistent measure without adopti ng any new measure in its place.  The issue that arises in this 
dispute, however, is whether an inconsistent m easure should be considered "removed" when it is 
replaced by a new implementing measure.  Taken liter ally, removal of the inconsistent measure could 
mean that the implementing Member has adopted an  act that formally repeals the inconsistent 
measure and replaces it with another measure, regardl ess of the content of the new measure and, in 
                                                     
 
719Article 22.6 specifies that the DSB, upon a request made within 30 days of the expiry of the 
reasonable period of time by the Member invoking the di spute settlement procedures, shall grant authorization 
to suspend concessions, or decide by consensus to reject  the request.  In addition, an arbitration procedure is 
envisaged under Article 22.6 in order to determine the proper level of the suspension of concessions and/or the 
sectors with respect to which the suspension is author ized.  As regards the level of the suspension of 
concessions, Article 22.4 requires that it be "equivale nt to the level of the nullification or impairment".  WT/DS321/AB/R 
 Page 131 
 
 
particular, of its compliance with the DSB's recommendations and rulings.  Such a literal 
interpretation of the first condition in Article 22. 8, however, does not comport with the other two 
conditions provided in that provision.  The second condition in Article 22.8 requires termination of 
the suspension of concessions if "the Member th at must implement recommendations or rulings 
provides a solution to the nullification or impairment of benefits", while the third condition refers to a 
situation where "a mutually agreed solution is reached".  The reference to "a solution to the 
nullification or impairment of benefits" indicat es that it is the inconsistency resulting from the 
measure, rather than the mere existence of the measu re, that must be remedied before the obligation to 
cease the suspension of concessions arises.  More over, by predicating the termination of the 
suspension of concessions on a "solution" either provided unilaterally (in the second condition) or 
reached by agreement (in the third condition), the tw o conditions require substantive resolution of the 
dispute.  Under these two conditions , termination of the suspension of concessions is the final step in 
a dispute to which there is substantive resolution of  the inconsistency found by the DSB.  To achieve 
a similar result under the first condition, Ar ticle 22.8 cannot be understood as requiring the 
termination of the suspension of concessions merely on the basis of a formal repeal of the measure 
that has been found to be inconsistent by the DSB.   All three conditions in Article 22.8 concern the 
circumstances under which the suspension of concessi ons must be terminated  because there has been 
a final and substantive resolution to the dispute. 
305. Reading the first sentence of Article 22.8 as a whole, the "removal" of "the measure found to 
be inconsistent" should be properl y understood to require nothing less than substantive removal of the 
inconsistent measure.  Substantiv e removal may be achieved by repea ling the inconsistent measure.  
Where a WTO Member adopts an implementing measure  that replaces the inconsistent measure, the 
implementing measure must bring about substantive compliance, that is, compliance with the DSB's 
recommendations and rulings and cons istency with the covered agreem ents.  We recognize that the 
first condition in Article 22.8 may be understood more narrowly as referring only to compliance with 
the DSB's recommendations and rulings.  However, a dispute could not be brought to its finality 
unless the implementing measure rectifies the inco nsistencies found in the DSB's recommendations 
and rulings and is not in other wa ys inconsistent with the covered agreements.  Interpreting the first 
condition as requiring substantive compliance, theref ore, will ensure that the first condition in 
Article 22.8 achieves the result obtained under the othe r two conditions in the same provision, that is, 
the final and substantive resolution of a dispute.  Such an interpretation is also congruent with the 
scope of compliance proceedings under Article 21.5 of th e DSU.  Pursuant to the first sentence of that 
provision, compliance proceedings cover the existen ce and consistency with the covered agreements 
of a measure taken to comply with the DSB's reco mmendations and rulings.  As further discussed in WT/DS321/AB/R 
Page 132  
 
section E, proceedings under Article  21.5 is the proper procedure to follow in determining whether the 
inconsistent measure has been removed within the meaning of Article 22.8.  
306. In terms of the first condition in Article 22.8, therefore, the application of the suspension of 
concessions may continue until the removal of the measure found by the DSB to be inconsistent 
results in substantive compliance.  If a disagreemen t arises as to whether substantive compliance is 
achieved, the fulfilment of the first conditio n in Article 22.8 cannot be confirmed unless the 
disagreement is resolved through multilateral disput e settlement.  Thus, the suspension of concessions 
continues to apply pending the outcome of the di spute settlement proceedings concerning the first 
resolutive condition in Article 22.8.  If, by rec ourse to a multilateral dispute settlement process, the 
implementing measure is found to bring about subs tantive compliance, the suspension of concessions 
may no longer be applied pursuant to the firs t condition in Article 22.8 and cessation of the 
suspension is required. 
307. This interpretation is supported by the sec ond sentence of Article 22.8, which provides: 
In accordance with paragraph 6 of Ar ticle 21, the DSB shall continue 
to keep under surveillance  the implementation of adopted 
recommendations or rulings, including those cases where ... concessions or other obligations have been suspended but the 
recommendations to bring a measur e into conformity with the 
covered agreements have not been implemented . 
The second sentence of Article 22.8 requires surv eillance by the DSB until its recommendations to 
bring a measure into conformity with the covered agreements have been implemented.  In other 
words, DSB surveillance is required until substantive compliance is achieved.   
308. Moreover, this interpretation of Article 22.8 is  consistent with the broader context provided 
by other provisions of the DSU relating to impl ementation of the DSB's recommendations and rulings 
and with the object and purpose of the DSU.  Article  22.1 of the DSU provides that the suspension of 
concessions is not to be "preferred to  full  implementation of a recommendation to bring a measure 
into conformity with the covered agreements".
720  The requirements in Article 21.5 to examine 
whether compliance measures exist and whether the me asures taken to comply are consistent with the 
covered agreements also suggest that substantive co mpliance is required, rather than formal removal 
of the inconsistent measure.  Furthermore, pursuant to Article 3.7, the suspension of concessions is the 
"last resort" available to the Member invoking th e dispute settlement procedures when compliance 
with the DSB's recommendations and rulings has not  been achieved within a reasonable period of 
                                                      
720Moreover, pursuant to Article 3.3, the "prompt settlement" of disputes "is essential to the effective 
functioning of the WTO and the maintenance of a proper balance between the rights and obligations of 
Members".  WT/DS321/AB/R 
 Page 133 
 
 
time.  To require the termination of suspension of concessions before substantive compliance is 
achieved would significantly weaken the effectivenes s of the WTO dispute settlement mechanism.  A 
Member authorized by the DSB to suspend con cessions enjoys the assurance under Article 22.8 that, 
until substantive compliance is achieved or, in case  of disagreement, multilaterally-confirmed, the 
suspension of concessions continues to be permitted under the DSU.   
309. The European Communities contends that the th ree conditions in Article 22.8 concerning the 
termination of the suspension of concessions are altern atives to each other and that it is sufficient to 
only look at one condition without considering th e others when determining whether the suspension 
of concessions must cease.721  We agree that the three conditions in Article 22.8 are alternatives to 
each other.  However, they are alternatives leading to  the same result, that is, the termination of the 
suspension of concessions and final resolution of a di spute.  It is difficult to envisage how a dispute 
could be finally resolved merely because the inconsis tent measure is formally removed, regardless of 
whether substantive compliance has been achieved.  The European Communities further submits that 
the second sentence of Article 22.8 contemplates that there may be situations in which "a measure has 
been removed" but "the matter rema ins under surveillance of the DSB".722  The second sentence of 
Article 22.8 specifically requires surveillance by the DSB where " concessions ... have been suspended  
but the recommendations to bring a measure into conf ormity with the covered agreement has not been 
implemented".  Thus, this provision clearly situates the ongoing surveillance with in the context of the 
continued suspension of concessions, indicating that  the authorization to suspend concessions does 
not lapse under Article 22.8 until substantive co mpliance is achieved.  Moreover, the European 
Communities' position, which requires the terminatio n of the suspension of concessions whenever an 
implementing measure is notified, undermines the effectiveness of the suspension of concessions in 
inducing full compliance.  Such a position is di fficult to reconcile with the DSU's objective of 
providing security and predictability to the multilateral trading system. 
310. Although Article 22.8 sets forth the resolutive conditions under which the suspension of 
concessions must cease to apply, it does not identify the procedures to be followed should a dispute arise as to whether one of the conditions has been satisfied.  This does not mean that Members can 
remain passive once concessions have been suspe nded pursuant to the DSB's authorization.  The 
requirement that the suspension of concessions must  be temporary indicates that the suspension of 
concessions, as the last resort available under the DSU when compliance is not achieved, is an 
abnormal state of affairs that is not meant to rema in indefinitely.  Members must act in a cooperative 
manner so that the normal state of affairs, that  is, compliance with the covered agreements and
                                                     
 
721European Communities' statement at the oral hearing. 
722Ibid. WT/DS321/AB/R 
Page 134  
 
absence of the suspension of concessions, may be restored as quickly as possible.  Thus, both the 
suspending Member and the implementing Member share the responsibility to ensure that the 
application of the suspension of concessions is "tem porary".  Moreover, the fulfilment of the first 
resolutive condition in Article 22.8 requires certain  actions from both Members.  The implementing 
Member is required to remove the measure found to be  inconsistent with a cove red agreement.  At the 
same time, the suspending Member is required to ensure that the suspension of concessions is only 
applied within the limits of Article 22.8.  Where, as in this dispute, an impl ementing measure is taken 
and Members disagree as to whether this measur e achieves substantive co mpliance, both Members 
have a duty to engage in WTO dispute settlement in order to establish whether the conditions in 
Article 22.8 have been met and whether, as a con sequence, the suspension of concessions must be 
terminated.  Once substantive compliance has be en confirmed through WTO dispute settlement 
procedures, the authorization to suspen d concessions lapses by operation of law ( ipso jure ), because it 
has been determined that one of  the resolutive conditions pursuant to Article 22.8 is fulfilled.
723  We 
examine in section E the procedural avenues that w ould be available should a disagreement arise as to 
whether the conditions in Article 22.8 have been satisfied. 
3. The Panel's Analysis Concerning Article 22.8 of the DSU  
311. The Panel found that "the phrase 'until such time as  the measure found to be inconsistent with 
a covered agreement has been removed' [in Article  22.8] means the illegality itself, and not only the 
measure, has been removed."724  The Panel considered that this interpretation is confirmed by the 
second sentence of Article 22.8, which refers to th e DSB keeping under surveillance the situations in 
which concessions have been suspended but the recommendations and rulings of the DSB have not 
been implemented.  In the Panel's view, the second sentence implied that "wha t is to be achieved is 
not the removal of the measure but the actual compliance with the recommendations and rulings of the DSB."
725  Therefore, according to the Panel, "Artic le 22.8 may be breached only if the European 
Communities has complied with the recommendations a nd rulings of the DSB and [the United States 
and Canada have] failed to immediately remove its  suspension of concessions or other obligations." 726  
We consider that the Panel was correct in reaching this finding.  In subsectio n 2, we found that the 
                                                      
723In contrast, where an inconsistent measure is re moved without being replaced  by a new measure, the 
objective condition in Article 22.8 would, in most cases , be met and the authority to suspend concessions would 
automatically lapse. 
724Panel Report, US – Continued Suspension , para. 7.283;  Panel Report, Canada – Continued 
Suspension , para. 7.299. 
725Panel Report, US – Continued Suspension , para. 7.284;  Panel Report, Canada – Continued 
Suspension , para. 7.300. 
726Panel Report, US – Continued Suspension , para. 7.285;  Panel Report, Canada – Continued 
Suspension , para. 7.301.  WT/DS321/AB/R 
 Page 135 
 
 
terms "until such time as the inconsistent measu re has been removed" in Article 22.8 require 
substantive compliance and that, until it is achieve d, the suspension of concessions may continue.  
312. The European Communities highlights the Panel' s statements, made in the context of its 
findings of procedural violations under Articles 23.2(a) and 23.1, that Directive 2003/74/EC "shows 
all the signs of an implementing measure ... adopted in good faith".727  The European Communities 
maintains that once a Member has adopted an impl ementing measure which it believes in good faith 
to bring about compliance, the suspension of concessions can no longer be applied.728  The question 
raised by this claim, therefore, is whether the "removal" of an inconsistent measure within the 
meaning of Article 22.8 may be established on the sole basis of a presumption of good faith compliance by the European Communities. 
313. The DSU makes reference to "good faith" in two provisions, namely, Article 4.3, which 
relates to consultations, and Artic le 3.10, which provides that, "if a dispute arises, all Members will 
engage in these procedures in good faith in an e ffort to resolve the dispute."  These provisions require 
Members to act in good faith with respect to the initiation of a dispute and in their conduct during a 
dispute settlement proceedings.  Neither provision  specifically addresses the question of whether a 
Member enjoys a presumption of good faith compliance in respect of measures taken to implement 
the DSB's recommendations and rulings.   
314. The Appellate Body has recognized that the principle of good faith, a principle well-
recognized in international law, applies in WTO di spute settlement.  As the Appellate Body stated in 
EC – Sardines : 
We must assume that Members of the WTO will abide by their treaty 
obligations in good faith, as required by the principle of  pacta sunt 
servanda   articulated in Article 26 of the Vienna Convention .  And, 
always in dispute settlement, every Member of the WT O must assume 
the good faith of every other Member .
729  (emphasis added) 
315. The Member required to implement the DS B's recommendations and rulings may be 
presumed to have acted in good faith when ad opting the implementing measure. However, the 
presumption of good faith attaches to the actor, but not to the action itself.  Thus, whilst the presumption of good faith concerns the reasons for which a Member acts, such a presumption does 
not answer the question whether the measure taken by the implementing Member has indeed brought 
about substantive compliance.  Similarly, the suspe nding Member can also be presumed to act in good 
                                                     
 
727Panel Report, US – Continued Suspension , para. 7.238;  Panel Report, Canada – Continued 
Suspension , para. 7.231. 
728European Communities' appellant's submission, para. 141. 
729Appellate Body Report, EC – Sardines , para. 278.  WT/DS321/AB/R 
Page 136  
 
faith in maintaining the suspension of concessions, but that does not entail that the suspension of 
concessions is necessarily consistent with Article 22. 8.  When a disagreement arises as to whether the 
implementing measure achieves substantive complia nce and whether the suspension of concessions 
may continue, it should be submitted for adjudication in dispute settlement proceedings.  In sum, a 
presumption of good faith, which can be claimed by bot h parties, does not offer a clear answer to the 
question of when inconsistencies arising from the orig inal measure should be considered to have been 
removed within the meaning of Article 22.8 of the DSU. 
316. In the light of our understanding of the presumption of good faith, we do not agree with the 
European Communities that there is a c ontradiction between the proposition that 
Directive 2003/74/EC is a measure adopted in good fa ith and the interpretation of Article 22.8 that 
substantive compliance is required fo r the first resolutive condition to be  met.  Even if the European 
Communities should be presumed to have acted in good faith when adopting the implementing 
measure, that does not mean that the measure  has achieved substantive compliance.   
317. If the removal of a measure found to be inconsiste nt were to be established on the sole basis 
of a presumption of good faith compliance, the DSB's authorization to suspend concessions would 
expire upon the adoption of an implementing meas ure and a mere unilateral declaration of the 
implementing Member that it removed the inconsiste nt measure.  As described above, the suspension 
of concession is the last resort available to a Me mber who has successfully challenged the consistency 
with the covered agreements of another Member's  measure.  The DSB's authorization to suspend 
concessions is necessarily preceded by a multi-stag e dispute settlement process.  This process may 
encompass:  (i) consultations, (ii) panel proceedings , (iii) appellate review, (iv) the adoption of the 
panel and Appellate Body re ports, (v) an arbitration to determine the reasonable period of time for 
implementation, (vi) compliance panel proceedings, (vii) compliance appellate review, and (viii) an 
arbitration to determine the level of suspensi on of concessions.  The authorization to suspend 
concessions is thus granted following a long pr ocess of multilateral dispute settlement in which 
relevant adjudicative bodies, as well as the DSB, render multilateral decisions at key stages of the 
process.  To allow the suspension of concessions to expire as a result of the application of a 
presumption of good faith with respect to a unilateral declaration of compliance would create an 
imbalance between the rights and obligations of the complainants and the respondents enshrined in 
the DSU and would undermine the effectiveness of the dispute settlement mechanism in providing 
security and predictability.  Rather, if the origin al respondent considers that it has implemented the 
DSB's recommendations and rulings such that it  has achieved substantive compliance, and the 
complainant who has been authorized to suspend concessions disagrees, that disagreement must be 
resolved multilaterally through WTO dispute settleme nt.  Thus, we share Canada's view that the  WT/DS321/AB/R 
 Page 137 
 
 
interpretation proposed by the European Communities is an "overly narrow and formalistic 
interpretation that fails to situate Article 22.8 in its proper context within the terms of the DSU."730 
318. Consequently, we disagree with the Europ ean Communities' assertion that "the mere 
existence  of an implementing measure adopted in good faith and its subsequent notification to the 
DSB" requires the United States and Canada to cease the application of the suspension of concessions 
authorized by the DSB.731 
319. The European Communities additi onally alleges that the Panel "fundamentally erred" in the 
manner in which it identified the "measure found to be inconsistent with a covered agreement" in 
order to determine whether "it has been re moved" within the meaning of Article 22.8.732  T h e  
European Communities claims that the Panel found that Directive 96/22/EC, that is, the measure 
found to be inconsistent with the  SPS Agreement  in  EC – Hormones , "was removed".  Nonetheless, 
the Panel also held that considering Directive 96/22/ EC as the measure found to be inconsistent with a 
covered agreement within the meaning of Article 22.8 is "unsatisfactory, as Directive 96/22/EC was 
replaced by Directive 2003/74/EC which also imposes an import ban".733   
320. We recall that, in EC – Hormones , Directive 96/22/EC was found to be inconsistent with 
Article 5.1 of the  SPS Agreement  because the import ban imposed by that Directive on meat from 
cattle treated with the six hormones at issue was not  based on a risk assessment that conformed to the 
requirements of the  SPS Agreement .734  In order to comply with the DSB's recommendations and 
rulings, the European Communities had to remove th e import ban or ensure that the import ban had a 
proper justification under the  SPS Agreement   by being based on a risk assessment under Article 5.1 
or as a provisional measure under Article 5.7.  T hus, the replacement of Directive 96/22/EC with 
Directive 2003/74/EC is insufficient for the measure found to be inconsistent in  EC – Hormones  to 
be considered removed for purposes of Article 22.8 of the DSU. 
321. The European Communities also asserts that "i nterpreting Article 22.8 as referring to 'actual 
compliance' allows the original complaining Memb er to make a unilateral determination of the 
substantive merits of the 'measure taken to comply ', without recourse to the procedures of the DSU 
and without respecting Article 23.1 of the DSU."735  In our view, this argument conflates the proper 
interpretation of Article 22.8 with the issue as to the proper procedure for resolving a dispute 
                                                      
730Canada's appellee's submission, para. 21. 
731European Communities' appellant's submission, para. 101. (original emphasis) 
732Ibid., para. 145. 
733Panel Report, US – Continued Suspension , para. 7.283;  Panel Report,  Canada – Continued 
Suspension , para. 7.299. 
734Appellate Body Report, EC – Hormones , paras. 6 and 253. 
735European Communities' appellant's submission, para. 152. WT/DS321/AB/R 
Page 138  
 
involving Article 22.8.  As discussed, Article 22.8 set s forth the resolutive conditions under which the 
suspension of concessions must cease, including the condition that the suspension of concessions shall 
only apply until the measure found to be  inconsistent has been removed.  The correct interpretation of 
Article 22.8 is that once substantive compliance is achieved, the suspending Member is required to cease the application of the suspension of concession s.  This, however, does not answer the question 
regarding the procedures to be followed in the even t a disagreement arises as to whether substantive 
compliance has been achieved and th e resolutive condition in Article 22. 8 has been met.  We address 
the available procedural avenues in section E. 
4. Did the Panel Exceed Its Mandate by Addressing the Conformity of 
Directive 2003/74/EC with the  SPS Agreement ? 
322. The European Communities claims that, in the context of reviewing the European 
Communities' second set of main claims under Article 23.1, read together with Articles 22.8 and 3.7 
of the DSU, the Panel exceeded the scope of its mandate by examining the conformity of 
Directive 2003/74/EC with the  SPS Agreement .  The European Communities maintains that it made a 
claim under Article 22.8 of the DSU in the alternative,  that is, only in the event that the Panel did not 
find any violation under Articles 23.1, 23.2(a), 3.7, 22.8, and 21.5 of the DSU.736  In the alternative 
claim, the European Communities alleges that the United States and Canada were required to 
terminate the suspension of concessions pursuan t to Article 22.8 because Directive 2003/74/EC 
achieved actual (rather than presumed) complian ce with the DSB's recommendations and rulings.737  
The European Communities explains that it made the alternative claim because "it was confident that, 
in any event, ... Directive 2003/74/EC was fu lly consistent with its WTO obligations."738  Therefore, 
the European Communities asserts, the Panel exceeded its terms of  reference by "ignoring the 
sequencing order of the legal claims made by th e European Communities" and by addressing the issue 
of actual compliance in order to determine whether the United States and Canada breached 
Article 22.8 of the DSU.739  
323. We recall that, in support of its claim under Ar ticle 23.1, read together with Articles 22.8 
and 3.7, the European Communities maintains that Directive 96/22/EC "was removed"740 within the 
meaning of Article 22.8 after being replaced by Directive 2003/74/EC and that "the mere  existence  
of an implementing measure adopted in good fait h and its subsequent notification to the DSB" 
                                                      
736European Communities' appellant's submission, para. 166. 
737Panel Report, US – Continued Suspension , para. 7.156;  Panel Report, Canada – Continued 
Suspension , para. 7.143. 
738European Communities' appellant's submission, para. 103. 
739Ibid., para. 175. 
740Ibid., para. 146.  WT/DS321/AB/R 
 Page 139 
 
 
required the United States and Canada to cease th e application of the suspension of concessions.741  
The European Communities adds that the continuati on of the suspension of concessions by the United 
States and Canada and their failure to initiate Artic le 21.5 proceedings necessarily implies that they 
have made a unilateral determination on the inc onsistency of the implementing measure with the 
DSB's recommendations and rulings, "in breach of Article 23.1 read together with Articles 22.8 
and 3.7 of the DSU".742  Therefore, the European Communitie s' assertion that the United States and 
Canada breached Article 23.1 in making "a unilate ral determination" is premised on their alleged 
failure to terminate the suspension of concessions  pursuant to Article 22.8 after the removal of 
Directive 96/22/EC, as well as their alleged failu re to initiate Article 21.5 proceedings.   
324. As we concluded in the previous sections, the inconsistent measure will not be considered 
removed within the meaning of Article 22.8 unless substantive compliance is achieved.  Therefore, 
whether Directive 2003/74/EC brings the European  Communities into compliance with the DSB's 
recommendations and rulings in  EC – Hormones  was an issue the Panel had to resolve in order to 
determine whether the United States and Canada were required to terminate the suspension of 
concessions pursuant to Article 22.8 and whethe r failing to do so constituted a violation of 
Article 23.1, read together with Articles 22.8, and 3.7 of the DSU.  Before the Panel, the European 
Communities maintained that it did not have to demonstrate actual compliance with the DSB's 
recommendations and rulings because it should benef it from a presumption of good faith compliance 
with respect to Directive 2003/74EC.743  We concluded, however, that a presumption that the 
European Communities acted in good faith when ad opting Directive 2003/74/EC is insufficient for 
establishing removal, within the meaning of Article 22.8, of the measure found to be inconsistent in 
EC – Hormones . 
325. On appeal, the European Communities emphasizes  that Directive 96/22/EC was replaced by 
Directive 2003/74/EC and thus the in consistent measure has been rem oved.  In the previous sections, 
we rejected the European Communities' formalistic  understanding of the phrase "the measure found to 
be inconsistent has been removed" according to which the repeal of the original measure and its 
replacement with a new measure would require cessati on of suspension, regardless of the content of 
the new measure.  Therefore, the distinction dr awn by the European Communities between its second 
set of main claims and its alternative claim is, in  our view, based on an incorrect interpretation of 
Article 22.8.  The fact that the European Commun ities described the question of actual compliance of 
Directive 2003/74/EC as an alternative claim did not preclude the Panel from evaluating whether 
                                                      
741European Communities' appellant's submission, para. 101. (original emphasis) 
742Ibid., para. 101. 
743Panel Report, US – Continued Suspension , para. 7.286;  Panel Report, Canada – Continued 
Suspension , para. 7.302. WT/DS321/AB/R 
Page 140  
 
there is substantive compliance, if doing so was ne cessary to adjudicate the second main claim of the 
European Communities under Articles 23.1, 22.8, and 3.7.  On the contrary, the Panel would have 
failed to correctly interpret and apply Article 22.8 if it had followed the approach of the European 
Communities and had refrained from addressing the issu e of whether the repeal of Directive 96/22/EC 
and its replacement by Directive 2003/74/EC resulted in substantive compliance.   
326. In  EC – Hormones , the European Communities' import ban on meat from cattle treated with 
oestradiol-17 β, progesterone, testosterone, trenbolone acet ate, zeranol, or MGA was found to be 
inconsistent with Article 5.1 of the  SPS Agreement  because it was not based on a proper risk 
assessment.
744  To implement the DSB's recommendations  and rulings, the European Communities 
adopted Directive 2003/74/EC, which repealed Dire ctive 96/22/EC.  Directive 2003/74/EC applies a 
ban on the importation of meat from cattle treated with oestradiol-17 β for growth-promotion 
purposes, while the importation of meat from cattle  treated with the other five hormones is 
provisionally forbidden.  According to the Eur opean Communities, Directive 2003/74/EC is based on 
a comprehensive risk assessment  that "sufficiently warrants"745 the permanent import prohibition 
regarding oestradiol-17 β and is therefore consistent with Article 5.1 of the  SPS Agreement .  The 
European Communities also contends that the risk assessment provides the "available pertinent 
information" on the basis of which the provisional prohibition regarding the other five hormones has 
been enacted.  Thus, in the European Communities'  view, the provisional import ban is consistent 
with Article 5.7 of the  SPS Agreement , which allows Members to adopt provisional SPS measures on 
the basis of available pertinent information in cases where "relevant scientific evidence is 
insufficient".  On this basis, the European Communities argues th at it has implemented the DSB's 
recommendations and rulings in  EC –  Hormones .746 
327. The Panel addressed the consistency w ith Articles 5.1 and 5.7 of the  SPS Agreement  of the 
import ban imposed by Directive 2003/74/EC.747  We have found that th e European Communities was 
required to bring about substantive compliance fo r the United States and Canada to be under an 
obligation to terminate the suspension of concessions pursuant to Article 22.8 of the DSU.  The DSB's
                                                      
744Appellate Body Report, EC – Hormones , para. 208. 
745European Communities' first written submission to the Panel, para. 17 (quoting Appellate Body 
Report, EC – Hormones , para. 253(l)). 
746Ibid., para. 17. 
747We note that the Panel reviewed, and rejected, th e United States' claim that  Directive 2003/74/EC 
was inconsistent with Article 5.2 of the  SPS Agreement .  (Panel Report, US – Continued Suspension , 
para. 7.573)  Moreover, both the United States and Canada claimed before the Panel that Directive 2003/74/EC 
was inconsistent with Article 3.3 of the  SPS Agreement .  The Panel found it unnecessa ry to examine the claims 
under Article 3.3, having already concluded that Directive 2003/74/EC was not consistent with Articles 5.1 and 5.7 of the  SPS Agreement .  (Ibid., para. 7.846;  Panel Report, Canada – Continued Suspension , para. 7.831)  
The Panel's findings with respect  to Articles 5.2 and 3.3 of the SPS Agreement  were not appealed.  We therefore 
find it unnecessary to examine wh ether these two provisions were properly before the Panel.    WT/DS321/AB/R 
 Page 141 
 
 
recommendations and rulings from  EC – Hormones  included a finding that the import ban on meat 
from cattle treated with oestradiol-17 β was inconsistent with Article 5.1 of the  SPS Agreement  
because it was not based on a proper risk assessment .  Thus, in order to determine whether the 
European Communities had complied with the DSB' s recommendations and rulings, the Panel had to 
examine whether the European Communities had brought its import ban relating to oestradiol-17 β 
into conformity with Article 5.1 of the  SPS Agreement  by basing the import ban in 
Directive 2003/74/EC relating to the same substance on a proper risk assessment. 
328. We face a somewhat different situati on in relation to Article 5.7 of the  SPS Agreement .  The 
European Communities did not invoke that provision in  EC – Hormones  to justify its import ban on 
meat from cattle treated with the other five hormon es.  Thus, the DSB's recommendations and rulings 
in  EC – Hormones  did not include findings under Article 5.7 of the  SPS Agreement .  Instead, the 
import ban relating to the other five hormones was found to be inconsistent with Article 5.1 because it 
was not based on a proper risk assessment.  This raises the question as to whether the European 
Communities' changed justification precluded the Pa nel from examining its consistency with the  SPS 
Agreement , and particularly with Article 5.7, a pr ovision that was not part of the DSB's 
recommendations and rulings in  EC – Hormones .  In our view, the Panel was not precluded from 
assessing the consistency of Directive 2003/74/EC w ith Article 5.7 for the following reasons.  The 
definitive import ban that was the subject of  EC – Hormones  and found to be inconsistent with 
Article 5.1 has been replaced, under Directive 2003/ 74/EC, by a provisional ban relating to the five 
other hormones.  The import ban applies to the same products:  meat from cattle treated with 
progesterone, testosterone, trenbolone acetate, zeranol, and MGA.  The European Communities 
replaced the original definitive ban with a provisi onal ban and invoked Article 5.7 as an alternative 
justification to Article 5.1.  The European Communities has characterized the import ban as a 
provisional one and has sought to justify it under Article 5.7 of the  SPS Agreement : 
The new Directive provides that the use for animal growth promotion 
of one of the six hormones in dis pute is permanently prohibited while 
the use of the other five is provisiona lly forbidden.  It is based on a 
comprehensive risk assessment and, th us, is fully compliant with the 
DSB recommendations and rulings. In  particular, as stipulated by the 
Appellate Body,  the results of the risk assessment  "sufficiently 
warrant" the definite import proh ibition regarding one of the 
hormones (Article 5.1 of the SPS Agreement ), and provide the 
"available pertinent information" on the basis of which the provisional prohibition regarding the other five hormones has been enacted (Article 5.7 of the SPS Agreement ).  Consequently, through 
Directive 2003/74/EC the European Communities has implemented WT/DS321/AB/R 
Page 142  
 
the rulings and recommendations in the Hormones  case.
748 (footnote 
omitted) 
Article 22.8 demands substantive compliance w ith the DSB's recommendations and rulings.  A 
change in justification, by itself, cannot be said to achieve substantive comp liance.  Compliance with 
the DSB's recommendations and rulings concerning Article 5.1 and the definitive ban on the five 
hormones cannot be established without reviewing the alternative justification for the provisional ban 
under Article 5.7.  If the new justification for the ban is not consistent with the  SPS Agreement , 
substantive compliance has not been achieved. 
329. We recall that the Appellate Body has stated th at, "pursuant to Article 7 of the DSU, the 
panel's terms of reference are governed by th e request for the establishment of a panel."749  W e  
recognize that the European Communities' requests for the establishment of a panel do not list 
Articles 5.1 and 5.7.750  Also, we are mindful that a panel requ est submitted by an original respondent 
in the post-suspension stage is different from a pa nel request in original and compliance proceedings 
in the pre-suspension stage.  In the requests for establishment of a panel, the European Communities 
asserts that it has brought itself into compliance with the DSB's recommendations and rulings which 
included a violation of Article 5.1.  It gives th e following reason why the suspensions of concessions 
could no longer be justified: 
In the same communication [in which Directive 2003/74/EC was 
notified to the DSB], the European Communities explained that it considers itself to have fully im plemented the recommendations and 
rulings of the DSB in the EC – Hormones dispute and that, as a 
consequence, it considers [the United States' and Canada's] 
suspension of concessions vis-à-vi s the European Communities to be 
no longer justified.
751 (footnote omitted) 
330. Directive 2003/74/EC specifies that the original definitive import ban that had been found to 
be inconsistent with the covered agreements was replaced by a permanent ban in respect of 
oestradiol-17 β and a provisional ban in relation to the ot her five hormones.  Such a provisional ban 
implicates Article 5.7 as explained above.  More over, the requests for establishment of a panel 
acknowledge that the United States and Canada did not consider that Directive 2003/74/EC complied 
with the  SPS Agreement : 
The [United States and Canada] disagreed and denied that the new 
Directive was based on science and that it implemented the DSB's recommendations and rulings.  Th e [United States and Canada] 
formally stated in the DSB that [t hey] considered the new Directive 
                                                     
 
748European Communities' first written submission to the Panel, para. 17. 
749Appellate Body Report, US – Carbon Steel , para. 124. 
750WT/DS320/6;  WT/DS321/6. 
751Ibid.  WT/DS321/AB/R 
 Page 143 
 
 
to be inconsistent with the Eur opean Communities obligations under 
the SPS Agreement and that [they] would continue to impose 
retaliatory duties on certain products from the European Communities.
752 (footnotes omitted) 
331. Finally, the European Communities claims in its  request that the United States' and Canada's 
conduct is inconsistent with Article 22.8 of the DSU.   It is evident from the panel requests that the 
consistency of the United States' and Canada's continued suspension with Article 22.8 was linked to 
the European Communities' implementation of the DSB's recommendations and rulings in EC – 
Hormones .  We fail to see how the claims explicitly lis ted in the panel requests by the European 
Communities could be resolved in isolation from the question of whether Directive 2003/74/EC has 
brought the European Communities into complian ce with these DSB's recommendations and rulings. 
332. Taken together, these elements support th e conclusion that the consistency of 
Directive 2003/74/EC with Articles 5.1 and 5.7 of the  SPS Agreement  was part of the matter to be 
examined by the Panel.  In these circumstances, we  reject the European Communities' claim that the 
Panel exceeded its terms of reference by addr essing the consistency of Directive 2003/74/EC with 
Articles 5.1 and 5.7 of the  SPS Agreement .  We uphold  the Panel's finding that "it has jurisdiction to 
consider the compatibility of the [European Communities'] implementing measure with the  SPS 
Agreement  as part of its review of the claim raised  by the European Comm unities with respect to 
Article 22.8 of the DSU."753 
E. Procedural Avenues for Resolving Disagreem ents as to Whether the Inconsistent 
Measure Has Been Removed under Article 22.8 of the DSU 
1. What Is the Appropriate Procedural Av enue to Resolve a Disagreement as to 
Whether the Inconsistent Measure Has Been Removed?  
333. The European Communities argues that, wher e a WTO Member continues to suspend 
concessions because it considers that the implementi ng measure does not achieve compliance with the 
DSB's recommendations and rulings or  is otherwise inconsistent w ith the covered agreements, the 
Member has an obligation to initia te Article 21.5 proceedings.   
334. Article 21.5 provides that: 
Where there is disagreement as to th e existence or consistency with a 
covered agreement of measures taken to comply with the 
recommendations and rulings such dispute shall be decided through recourse to these dispute settlement procedures, including wherever 
                                                     
 
752WT/DS320/6;  WT/DS321/6. 
753Panel Report, US – Continued Suspension , para. 7.379;  Panel Report, Canada – Continued 
Suspension , para. 7.376. WT/DS321/AB/R 
Page 144  
 
possible resort to the original panel.  The panel shall circulate its report within 90 days after the date of referral of the matter to it.  
When the panel considers that it ca nnot provide its report within the 
time frame, it shall inform the DSB in writing of the reasons for the delay together with an estimate of the period within which it will 
submit its report. 
335. The European Communities reads the words "sha ll be decided" and "including" as indicating 
an obligation to have recourse to an Article 21.5 pa nel in the sense that it constitutes a mandatory step 
in the process of adjudicating disagreements over th e existence or consistency of measures taken to 
comply, even though additional procedural steps may also be available under the DSU.  However, the United States and Canada read the phrase "shall be decided through recourse to these dispute 
settlement procedures" to mean that recourse coul d encompass any of the procedures available under 
the DSU, and not just an Article 21.5 panel procedure.  The phrase "including wherever possible ... 
the original panel" would then be read as one of several options.  This seems  to be the view taken by 
the Panel when it read the phrase to mean resort "t o the panelists that reviewed the original case, 
rather than to other individuals."
754  The Panel further found that several procedural means are 
available to the European Communities for obtaining the termination of the suspension of 
concessions, including good offices and consultations, arbitration under Article 25 of the DSU, panel 
proceedings under Article 21.5 of the DSU, and ne w panel proceedings involving a challenge against 
the continued suspension of concessions.755 
336. The opening clause of Article 21.5 specifies the typ es of disputes that fall within the scope of 
this provision, that is, those involving a disagreem ent as to the existence or consistency with a 
covered agreement of measures taken to comply wi th the recommendations and rulings of the DSB.  
The word "shall" in Article 21.5 indicates that such  disagreements must be resolved through recourse 
to "these dispute settlement procedures".  Read t ogether with the second sentence of Article 21.5, 
"these dispute settlement procedures" do not refer generally to all proceedings under the DSU, but 
specifically to the panel proceedings envisaged in Article 21.5, in which the original panelists are 
preferred for the composition of the panel and in  which the time frame of the proceedings is 
shortened.  In other words, Article 21.5 dictates that  panel proceedings pursuant to this provision are 
the procedures that must be followed for adjudica ting the cause of action as framed in its opening 
clause.   
337. As we see it, at the core of this dispute is  a disagreement as to whether Directive 2003/74/EC, 
the measure taken by the European Communities to comply with the DSB's recommendations and 
                                                      
754Panel Report, US – Continued Suspension , para. 7.351;  Panel Report, Canada – Continued 
Suspension , para. 7.349. 
755Panel Report, US – Continued Suspension , para. 7.350;  Panel Report, Canada – Continued 
Suspension , para. 7.348.  WT/DS321/AB/R 
 Page 145 
 
 
rulings in EC – Hormones , achieves substantive compliance.  Before the Panel, the European 
Communities claimed that it had removed Direc tive 96/22/EC, which had been found to be 
inconsistent in EC – Hormones , and that the United States and Canada breached Article 23.1, read 
together with Articles 22.8 and 3.7, by failin g to terminate the suspension of concessions.756  T h e  
United States and Canada disagreed that they were in breach of Article 22.8 and argued that it has not 
been demonstrated that the Eu ropean Communities has in fact removed its WTO-inconsistent 
measure.757  Because the phrase "until such time as the m easure found to be inconsistent with a 
covered agreement has been removed" in Article 22.8 must be properly interpreted as referring to 
substantive compliance, the disagreement as to wh ether such compliance has been achieved is the 
central issue that must be resolved in order to assess the legality of the continued suspension. 
338. Article 21.5 provides for specific procedures for adjudicating a disagreement as to the 
consistency with the covered agr eements of measures taken by a Member to implement the DSB's 
recommendations and rulings.  Thus, panel proceedi ngs under Article 21.5 is the proper procedure for 
resolving the disagreement as to whether Directiv e 2003/74/EC has achieved substantive compliance 
and whether, consequently, the resolutive condition in  Article 22.8 that requires the termination of the 
suspension of concessions has been met.  Indeed, as the Panel pointed out, "the option naturally 
coming to mind when it comes to reviewing complia nce is the procedure provided under Article 21.5 
of the DSU."758  The Panel also recognized that it "perfo rmed functions similar to that of an 
Article 21.5 panel" by addressing the consis tency with the covered agreements of 
Directive 2003/74/EC.759   
339. The Panel nonetheless found that Article 21.5 pa nel proceedings were not "the only avenue 
available to address a claim of compliance by a Member alleging to have complied with recommendations and rulings of the DSB".
760  Rather, as described above, the Panel found that good 
offices, consultations, and arbitration under Article 25 of the DSU were other procedures available to 
the European Communities for obtaining the te rmination of the suspension of concessions.  
340. Certainly, parties to a dispute are not precluded from pursuing consensual or alternative 
means of dispute settlement foreseen in the DSU.  Article 3.7 of the DSU provides that "[a] solution 
                                                      
756Panel Report, US – Continued Suspension , para. 7.252;  Panel Report, Canada – Continued 
Suspension , para. 7.245. 
757Panel Report, US – Continued Suspension , para. 7.264;  Panel Report, Canada – Continued 
Suspension, para. 7.261. 
758Panel Report, US – Continued Suspension , para. 7.351;  Panel Report, Canada – Continued 
Suspension , para. 7.349.   
759Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3.   
760Panel Report, US – Continued Suspension , para. 7.355;  Panel Report, Canada – Continued 
Suspension , para. 7.353. WT/DS321/AB/R 
Page 146  
 
mutually acceptable to the parties to a dispute and cons istent with the covered agreements is clearly to 
be preferred."  To reach a mutually acceptable solu tion, Members can engage in consultations or  
resort to mediation and good offices.  Moreover, Artic le 25 provides for arbitration as an alternative to 
panel proceedings for dispute resolution.  Consulta tions, mediation, good offices, and arbitration are, 
however, alternatives to compulsory adjudication a nd require the consent of the parties.  In the 
absence of such consent, they cannot lead to a binding decision.  Thus, it is important to distinguish 
between these consensual means of  dispute resolution, which are al ways at the Members' disposal, 
and adjudication through panel pr oceedings, which are compulsory.  It is in this sense that 
Article 21.5 is cast in obligatory language.  In th is dispute, it is clear that a mutually acceptable 
solution was not reached and the European Commun ities decided to resort to adjudication.  In 
addition, the parties to this dispute were unable to agree on an arbitration procedure pursuant to 
Article 25 of the DSU.
761  The issue before us, therefore, is which procedure must be followed when 
parties do not avail themselves of the consensual a nd alternative means of dispute resolution provided 
in the DSU, and the dispute must pr oceed to the adjudication phase.   
341. Another possibility the Panel identified are ne w panel proceedings involving a challenge 
against the legality of the con tinued suspension of concessions, su ch as the European Communities' 
initiation of the current proceedings.762  As discussed, the legality of  the continued suspension of 
concessions in this dispute hinges on whether Dir ective 2003/74/EC achieves substantive compliance, 
an issue that should be properly adjudicated in Article 21.5 proceedings.  The Panel itself recognized 
that it had to "perform functions simila r to that of an Article 21.5 panel".763  By contrast, the cause of 
action in new panel proceedings normally does not i nvolve the issue of whether a measure taken to 
comply with the DSB's recommendations and rulings is  consistent with the c overed agreements.  The 
European Communities initiated the current proceedi ngs, in part, on account of its belief that an 
original respondent is precluded from initiating Article  21.5 panel proceedings.  We address this issue 
in subsection 2 below. 
342. Furthermore, a disagreement under Article 22.8 concerning the removal of "a measure found 
to be inconsistent" in an original proceeding does no t exist in the abstract but, rather, occurs in the 
context of a pre-existing dispute that gave rise to  the DSB's recommendations and rulings.  Recourse 
                                                      
761The European Communities alleges that it proposed to the United States to submit the dispute to 
arbitration under Article 25 of the DSU, but the Unite d States refused. (European Communities' appellant's 
submission, para. 62) 
762Panel Report, US – Continued Suspension , para. 7.350;  Panel Report, Canada – Continued 
Suspension , para. 7.348. 
763Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3.  WT/DS321/AB/R 
 Page 147 
 
 
to Article 21.5 proceedings keeps the successive pro ceedings relating to the same dispute within "a 
continuum of events"764, and is conducive to reaching a final resolution of the dispute.   
343. Finally, in contrast to new panel proceedings, recourse to Article 21.5 is a more efficient use 
of the dispute settlement system.  As the Appellate Body observed:  
First, the composition of an Article 21.5 panel is, in principle, already 
determined—wherever possible, it is the original panel. These 
individuals will be familiar with th e contours of the dispute, and the 
experience gained from the original proceedings should enable them 
to deal more efficiently with matters arising in an Article 21.5 
proceeding "against the background of the original proceedings".  Secondly, the time-frames are shorte r—an Article 21.5 panel has, in 
principle, 90 days in which to issue its report, as compared to the six to nine months afforded original panels.
765 
344. As discussed, underlying this dispute concerni ng the continued suspension of concessions lies 
a disagreement over the consistency with the cove red agreements of Directive 2003/74/EC, a measure 
taken by the European Communities to comply with the DSB's recommendations and rulings in EC – 
Hormones .  The individuals who served in the panel in EC – Hormones  were familiar with the 
background of the dispute and the inconsistencies wi th the covered agreements they had found with 
respect to Directive 96/22/EC.  Recourse to Article 21.5 panel proceedings would allow these 
individuals to examine whether the inconsistencies found in EC – Hormones  have been rectified by 
Directive 2003/74/EC.  Such proceedings would be nefit from their knowledge and expertise gained 
from serving as panelists in EC – Hormones , and would be adjudicated within a shorter time frame 
than regular panel proceedings.  Recourse to Artic le 21.5 proceedings under such circumstances is 
therefore also consistent with the objective of the dispute settlement system of achieving prompt 
settlement of disputes. 
345. In sum, we consider that recourse to Ar ticle 21.5 panel proceedings is the proper  course of 
action within the procedural structure of the DSU in cases where, as in this dispute, a Member subject 
to the suspension of concessions has taken an im plementing measure and a disagreement arises as to 
whether "the measure found to be inconsistent w ith a covered agreement has been removed" within 
the meaning of Article 22.8.  Therefore, we share the European Communities' view that Article 21.5 panel proceedings are the procedures to be follo wed where there is disagreement as to whether 
Directive 2003/74/EC has achieved substantive comp liance.  We turn now to examine which party 
may initiate the Article 21.5 panel proceedings. 
                                                     
 
764Appellate Body Report, Mexico – Corn Syrup (Article 21.5 – US) , para. 121. 
765Appellate Body Report, US – Softwood Lumber IV (Article 21.5 – Canada) , para. 71. WT/DS321/AB/R 
Page 148  
 
2. Is the European Communities Precluded from Initiating Article 21.5 Panel 
Proceedings Regarding Whether Directive 2003/74/EC Has Brought It into 
Compliance?  
346. The European Communities argues that the Pa nel erred in finding that proceedings under 
Article 21.5 could have been initiated by the Eur opean Communities as the original responding party 
in EC – Hormones .766  According to the European Communiti es, "it is inherent in the wording, 
context and object and purpose of the provision that it is the obligation of the complaining party to 
have recourse to Article 21.5."767   
347. A "disagreement" as to the consistency with the WTO agreements of a measure taken to 
comply arises from the existence of conflicting views: the original complainant's view that such a measure is inconsistent with the WTO agreements or brings about only partial compliance, and the 
original respondent's view that a measure is cons istent with the WTO agreements and brings about 
full compliance with the DSB's recommendations a nd rulings.  Article 21.5 does not indicate which 
party may initiate proceedings under this provision.  Rather, the language of the provision is neutral 
on this matter, and it is open to eith er party to refer the matter to an Article 21.5 panel to resolve this 
disagreement.  The text of Article 21.5, therefore,  leaves open the possibility that either party to the 
original dispute may initiate the proceedings.  Thus, contrary to th e European Communities' 
argument, the text of Article 21.5 does not preclude  an original respondent from initiating proceedings 
under that provision to obtain confirmation of th e consistency with the WTO agreements of its 
implementing measure. 
348. Moreover, we recall that the suspension of con cessions is an abnormal state of affairs because 
it is the last resort available under the DSU wh en compliance is not achieved.  Pursuant to 
Article 22.8, this abnormal state of affairs must  be "temporary" and must be brought back to 
normality as soon as possible.  Consequently, both the suspending Member and the implementing Member share the responsibility to ensure that the suspension of concessions is not applied 
indefinitely.  Thus, initiation of Article 21.5 proceed ings by either Member, as soon as possible, to 
examine the consistency with the covered agreemen ts of Directive 2003/74/EC would contribute to a 
prompt resolution of the disagreement as to whethe r the inconsistent measure has been removed and 
whether the suspension of concessions must be  terminated pursuant to Article 22.8.  
349. The European Communities advances several reasons why initiation of Article 21.5 panel 
proceedings by the original respondent is not permissi ble, including:  (i) the adversarial nature of the
                                                     
 
766Panel Report, US – Continued Suspension , para. 7.355;  Panel Report, Canada – Continued 
Suspension , para. 7.353.  
767European Communities' appellant's submission, para. 75.  WT/DS321/AB/R 
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WTO dispute settlement system and its inapplicab ility to a Member's request for an "abstract 
confirmation" of the consistency of a measure;  (ii)  the difficulty in defining the Article 21.5 panel's 
terms of reference;  (iii) the possibility that the orig inal complainants would refuse to participate;  and 
(iv) the lack of recommendations and rulings di rectly addressing the illegality of the continued 
suspension of concessions should the measure taken to  comply be found to be  consistent with the 
WTO agreements.  We address below each of the ob jections raised by the European Communities. 
(a) The "Adversarial" Nature of the WTO Dispute Settlement System 
350. According to the European Co mmunities, an implementing Member cannot have recourse to 
Article 21.5 of the DSU to confirm the consistenc y with the WTO agreements of its own measures, 
because the dispute settlement system is based on a dversarial proceedings and is not applicable to 
"requests for an abstract confirmation of the consistency of a measure".768  The European 
Communities adds that its understanding of Article 21 .5 is confirmed by the concept of a "dispute" as 
reflected in Article 3.3 of the DSU, which, according the European Communities, "assumes a 
situation where one Member challenges the measure of another Member" because the former considers that its rights are being affected.
769  The European Communities al so refers to the text of 
Article XXIII:1 of the GATT 1994 which contains langua ge similar to that in Article 3.3 of the DSU. 
351. Article 3.3 provides that: 
The prompt settlement of situati ons in which a Member considers 
that any benefits accruing to it directly or indirectly under the 
covered agreements are being impair ed by measures taken by another 
Member is essential to the effective functioning of the WTO and the maintenance of a proper balance between the rights and obligations of Members.  
352. It is evident that the implementing Member woul d not normally consider its benefits to have 
been impaired by the measure it has itself take n to comply with the DSB's recommendations and 
rulings.  In the post-suspension stage of a disput e, however, an original respondent would initiate 
Article 21.5 panel proceedings for a specific reason:   to obtain a multilateral confirmation that its 
implementing measure has achieved substantive complia nce, so as to render the continued application 
of the suspension of concessions unlawful pursuant to Ar ticle 22.8.  The situatio n is thus one of those 
envisaged under Article 3.3, in that the original respondent considers that its benefits under the 
covered agreement are being impaired by the susp ension of concessions maintained by the original 
complainant, which is denied by the suspending  Member.  The task of an Article 21.5 panel,
                                                     
 
768European Communities' appellant's submission, para. 78. (emphasis omitted) 
769Ibid., para. 85. WT/DS321/AB/R 
Page 150  
 
established at the request of the original res pondent, is to determine whether the implementing 
measure brings about substantive compliance.  There is nothing "abstract" about such a determination;  
it results in an adjudication with real consequences, including, in particular, wh ether the application of 
the suspension of concessions may continue. 
(b) The Terms of Reference of an Ar ticle 21.5 Panel Requested by the 
Original Respondent 
353. The European Communities submits that "[i] t would be manifestly impossible for the 
European Communities to fulfil th e very basic requirements of Article 6 for the purposes of seeking 
confirmation of the consistency with the WTO agre ements of its implementi ng measure since it would 
not be in a position to identify the provisions of the  SPS Agreement  that are violated."
770  We agree 
that the original respondent that has taken a measure  to comply cannot be expected to speculate as to 
the violations that could possibly be raised against its measure by other Members, and this is not what 
the original respondent is expected to do if it in itiates Article 21.5 panel proceedings.  Rather, the 
original respondent will be able to identify in its  panel request the measure it has taken to comply and 
the specific inconsistencies found in the DSB's recommendations and rulings in the original 
proceedings, and claim before the Article 21.5 panel that it has complied with the DSB's recommendations and rulings by rectifying those in consistencies.  It would then be for the 
Article 21.5 panel to determine if the measure taken to comply does, in fact, rectify the 
inconsistencies identified in the DSB's recommendations and rulings. 
354. The original complainant may respond to the a llegations of compliance made by the original 
respondent.  If, however, the original complain ant considers that the implementing measure is 
inconsistent with provisions of the WTO agreements  not covered in the request for the establishment 
of a panel by the implementing Member, it may file  its own request for the establishment of a panel 
under Article 21.5 identifying those provisions that it considers should be examined by the 
Article 21.5 panel.  It would be for the Article 21.5 panel to determine if the implementing measure 
violates the WTO agreements in ways different from the original measure or whether certain claims 
fall outside the scope of Article 21.5 proceedings.
771  The original complainant would be expected to
                                                      
770European Communities' appellant's submission, para. 88. 
771As the Appellate Body has explained, a complainant who had failed to make out a  prima facie   case 
in the original proceedings regarding an element of the measure that remains unchanged since the original 
proceedings may not re-litigate the same claim with respect to the unchanged element of the measure in the Article 21.5 proceedings. (Appellate Body Report, EC – Bed Linen (Article 21.5 – India) , paras. 87 and 96)  
Similarly, a complainant may not reasse rt the same claim against an uncha nged aspect of the measure that was 
found to be WTO-consistent  in the original proceedings. (Appellate Body Report, US – Shrimp (Article 21.5 – 
Malaysia) , para. 96)  Moreover, a complaining Member ordinarily would not be allowed to raise claims in the 
Article 21.5 proceedings that it coul d have pursued in the original proc eedings, but did not. (Appellate Body 
Report, US – Upland Cotton (Article 21.5 – Brazil) , para. 211)  WT/DS321/AB/R 
 Page 151 
 
 
do so as soon as possible after adoption of an implementation measure or after the filing of the 
original respondent's panel request, so that both Article 21.5 panel requests may be referred to the 
original panel wherever possible, allowing review of all the issues relating to substantive compliance 
in the same Article 21.5 proceedings.772   
355. Such an approach is consistent  with the requirements of Article 22.8 of the DSU.  As noted 
above, Article 22.8 provides certain resolutive cond itions which, if met, render the suspension of 
concessions without legal basis.  The suspending Member and the implementing Member share the 
responsibility to ensure that the suspension of c oncessions is applied only insofar as none of the 
conditions laid down in Article 22.8 are met.  Thus , both Members have an obligation to engage in a 
cooperative manner in WTO dispute settlement to establish whether the suspension of concessions 
can continue or must be discontinued pursuant to  Article 22.8.  Irrespective of who initiates the 
Article 21.5 panel proceedings, a finding of an Arti cle 21.5 panel that the implementing Member has 
removed the inconsistent measure means that one of the resolutive conditions in Article 22.8 is met.  
This finding, once adopted by the DSB–the same body that authorized the suspension of concessions–
signifies that the inconsistency against which the suspension of concessions was authorized has now 
been remedied.  Thus, by operation of law ( ipso jure ), the suspension of concessions may no longer 
be applied.   
(c) The Original Complainants' Incentive to Participate in Article 21.5 
Panel Proceedings Initiated by the Original Respondent 
356. The European Communities further submits that it "appears that the United States and Canada 
as 'defending parties' would not be obliged to participate"773 in Article 21.5 panel proceedings initiated 
by the European Communities.  In support of this  argument, the European Communities referred to 
the fact that in EC – Bananas III (Article 21.5 – EC) , one of the original complainants (the United 
States) refused to participate in the Article 21.5 pa nel proceedings that the original respondent (the 
European Communities) had initiated.  The Europ ean Communities therefore takes issue with the 
Panel's reference to that dispute in finding that Article 21.5 panel pr oceedings may be initiated by the 
original respondent. 
357. We note that the panel in EC – Bananas III (Article 21.5 – EC)  did not find that it was 
precluded from examining the European Communiti es' claims because the European Communities 
                                                      
772Even if delays between the original respondent's and original complainant's panel requests do not 
allow for harmonization pursuant to Article 9 of the accelerated working schedules under Article 21.5, the matter raised by the original respondent and the original  complainant would nevertheless, wherever possible, be 
referred to the same individuals that served on the original panel.  
773European Communities' appellant's submission, para. 90. WT/DS321/AB/R 
Page 152  
 
had been the respondent in the original proceedings.
774  Moreover, the exceptional circumstances in 
EC – Bananas III (Article 21.5 – EC) , including the particular request made by the European 
Communities in those proceedings, could explain th e lack of participation of certain original 
complainants and that panel's decision not to ma ke a ruling on the consistency of the European 
Communities' first implementing measure.  In EC – Bananas III (Article 21.5 – EC) , an Article 21.5 
panel was established at the requ est of one of the original complainants, Ecuador, in which the 
European Communities' first implementing measure was found to be inconsistent with the WTO 
agreements.  There was also an ongoing arbitrati on pursuant to Article 22.6 of the DSU between the 
European Communities and the United States.775  That dispute, on its unusual facts, does not lead to 
the conclusion that an Article 21.5 panel would be  precluded from making an objective assessment of 
the matter referred to it by the original respondent.   
358. We recognize that it is theoretically possible for the original complainant to refuse to 
participate in Article 21.5 proceedings initiated by the original respondent.776  Yet, this is not a feature 
that may only occur in Article 21.5 proceedings initia ted by the original respondent, because the DSU 
does not provide the means to compel any party to participate in any dispute settlement proceedings.  
A defending party who refuses to participate in  dispute settlement proceedings will lose the 
opportunity to defend its position and will risk a findi ng in favour of the complaining party that has 
established a  prima facie   case.777  Similarly, in Article 21.5 panel proceedings initiated by the 
original respondent, the original complainant who refuses to participate forgoes the opportunity to 
explain to the Article 21.5 panel why the measure take n to comply fails to rectify the inconsistencies 
found in the original proceeding and, conseque ntly, why the suspension of concessions remains 
justified under Article 22.8 despite the measure taken to comply.  Absent any rebuttal by the original 
complainant, the Article 21.5 panel will ma ke its determination on the basis of a  prima facie   case 
presented by the original respondent that its im plementing measure has brought it into compliance 
with the DSB's recommendations and rulings.  Th erefore, where the original complainant has 
suspended concessions according to the DSB's author ization, the original complainant would have a 
strong incentive to participate lest the authoriza tion to suspend concessions lapses as a result of the 
adoption by the DSB of the Article 21.5 panel's fi nding that the original respondent has brought itself 
into compliance.   
359. Like any other panel, an Article 21.5 panel est ablished in the post-suspension stage, at the 
request of the original respondent, would be bound to make an objective assessment of the matter.  
                                                      
774Panel Report, EC – Bananas III (Article 21.5 – EC) , para. 4.18. 
775We do not need to express a view here on whether the consistency of the implementation measure 
could or should have been addressed by the arbitrators acting pursuant to Article 22.6 of the DSU. 
776European Communities' appellant's submission, para. 89. 
777For the appellate stage, see Rule 29 of the Working Procedures .  WT/DS321/AB/R 
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The ultimate issue before such a pa nel is whether the measure found to be inconsistent with a covered 
agreement has been removed.  We have interprete d "removed" to mean substantive compliance.  The 
question is which party bears the burden of proof in respect of the issues of substantive compliance.  
Is the burden to be allocated according to a mechan istic rule that it is for the party initiating the 
proceedings to prove substantive compliance or is  it the case that the burden of proof is allocated 
according to different principles?  Much of the reluctance of the parties to secure a definitive 
determination in respect of Article 22.8 is the a pprehension that, upon initiation, a party will attract 
the full burden of proof. 
360. In our view, the allocation of the burden of proof , in the context of Article 22.8, should not be 
determined simply on the basis of a mechanistic ru le that the party who initia tes the proceedings bears 
the burden of proof.  As we have indicated, in case of a disagreement, both parties are under an 
obligation to secure a definitive multilateral dete rmination as to whether the suspension of 
concessions must be terminated.  The burden of proo f does not attach to a party simply because such 
party discharges this obligation.  To hold otherw ise would create a disincentive to act in a manner 
which we consider to be obligatory and desirable.   
361. The allocation of the burden of proof in the c ontext of claims arising under Article 22.8 is a 
function of the following considerations.  First, what is the nature of the cause of action that is framed 
under Article 22.8.  Second, the practical question as to which party may be expected to be in a 
position to prove a particular issue.  Third, cons ideration must be given to the requirements of 
procedural fairness. 
362. Since the suspension of concessions is a remedy of last resort imposed after an elaborate 
multilateral dispute settlement process, in our view, it  is appropriate that the Member whose measure 
has brought about the suspension of concessions shoul d make some showing that it has removed the 
measure found to be inconsistent by the DSB in the original proceedings, so that normality can be 
lawfully restored.  This requires that the original  respondent will have an onus to show that its 
implementing measure has cured the defects identif ied in the DSB's recommendations and rulings.  
The quantum of proof entailed by this is a clear description of its implementing measure, and an adequate explanation regarding how  this measure rectifies the inc onsistencies found in the original 
proceedings, so as to place the Article 21.5 panel in  a position to make an objective assessment of the 
matter and, in the absence of rebuttal, to rule in favour of the original respondent.   
363. If the original respondent initiates Article 21. 5 proceedings to determine that the first 
resolutive condition in Article 22.8 has been fulfille d, and, consequently, that the suspension of 
concessions must end, and the original complainant fails to appear and answer the case, what would WT/DS321/AB/R 
Page 154  
 
the original respondent need to establish to satisfy a panel that  the resolutive condition has been 
fulfilled?  The original respondent, in this situati on, would be required to place evidence before the 
Article 21.5 panel sufficient to permit the panel,  in carrying out its duty, to make an objective 
assessment of the matter.  The quantum of evidence necessary for this purpose is the burden of proof, 
described above, that attaches to the original respondent.   
364. In respect of all other issues, the burden of pr oof rests upon the original complainant.  Such 
issues may include a claim that the implementing measu re is otherwise inconsis tent with the covered 
agreements or that the implementing measure re mains wanting for reasons not traversed by the 
original respondent in discharging its burden of proof. 
365. This allocation of the burden of proof is also c onsistent with the parties' shared responsibility 
to ensure that the suspension of c oncessions is "temporary", and that th e normal state of affairs, that 
is, conformity with the covered agreements and ab sence of the suspension of concessions, is restored 
as quickly as possible. 
(d) The Lack of Recommendations and Rulings Regarding the Legality 
of the Continued Suspension of Concessions 
366. The European Communities further states that , if it had initiated Article 21.5 panel 
proceedings in this case, the Article 21.5 panel could not have made r ecommendations addressed to 
the United States and Canada to cease the suspensi on of concessions, because an Article 21.5 panel 
would only have had jurisdiction to rule on the compliance of the implementing measure.
778 
367. A finding that the implementing Member has achieved substantive compliance means that the 
first resolutive condition in Article 22.8 has been met.   Such a finding, adopted by the DSB as part of 
the Article 21.5 panel (and Appellate Body) report(s), would, by operation of law ( ipso jure ), result in 
the termination of the DSB's authorization to susp end concessions.  This result obtains irrespective of 
whether the Article 21.5 panel was initiated by the origin al respondent or by the original complainant.  
It does not depend on which party initiates the Arti cle 21.5 panel proceedings.  Rather, the result 
depends on whether the Article 21.5 panel confirms  that the implementing Member has brought itself 
into substantive compliance, thereby triggering the obligation to cease applying the suspension of 
concessions, as required by Article 22.8 of the DSU. 
368. In sum, we are not persuaded by the Europ ean Communities' argument that an original 
respondent in the post-suspension stage of a dis pute would be precluded from initiating Article 21.5 
proceedings.  Therefore, we find  that the Panel did not err in stating that proceedings under 
                                                      
778European Communities' appellant's submission, para. 92.  WT/DS321/AB/R 
 Page 155 
 
 
Article 21.5 of the DSU may be initiated not only by the complainant, but also by the respondent in 
the original proceedings. 
F. Analysis of the Panel's Findings of "Procedural Violations" 
369. The United States and Canada allege that the Panel erred in finding that they breached 
Articles 23.2(a) and 23.1 of the DSU by continuing the suspension of concessions after the 
notification of Directive 2003/74/EC779, and request the Appellate Body to reverse these findings.  In 
particular, the United States and Canada assert that th e Panel erred in finding that:  (i) through the 
maintenance of the suspension of concessions agai nst the European Commun ities, they are seeking 
the redress of a violation with respect to Direc tive 2003/74/74/EC;  and (ii) they made a unilateral 
determination to the effect that a violation has occurred without recourse to dispute settlement under 
the DSU, in contravention of Article 23.2(a).   
1. The Prohibition on Certain Unilateral Actions – Article 23 of the DSU  
370. We begin our analysis with the interpretation of  the terms of Article 23 that are relevant to 
this dispute.  Entitled "Strengthening of th e Multilateral System", Article 23 provides that: 
1.      When Members seek the redress of a violation of obligations or 
other nullification or impairment  of benefits under the covered 
agreements or an impediment to the attainment of any objective of the covered agreements, they shall have recourse to, and abide by, the rules and procedures of this Understanding. 
2.      In such cases, Members shall: 
(a)     not make a determination to the effect that a violation has 
occurred, that benefits have been nullified or impaired or that the attainment of any objective of the covered agreements has been impeded, except through recourse to  dispute settlement in accordance 
with the rules and procedures of this Understanding, and shall make any such determination consistent with the findings contained in the 
panel or Appellate Body report adopted by the DSB or an arbitration 
award rendered under th is Understanding; 
(b)     follow the procedures set forth in Article 21 to determine the 
reasonable period of time for the Member concerned to implement the recommendations and rulings; and 
(c)     follow the procedures set forth in Article 22 to determine the 
level of suspension of concessions or other obligations and obtain 
DSB authorization in accordance with those procedures before suspending concessions or other obligations under the covered 
                                                     
 
779Panel Report, US – Continued Suspension , paras. 7.251 and 7.856;  Panel Report, Canada – 
Continued Suspension , paras. 7.244 and 7.841. WT/DS321/AB/R 
Page 156  
 
agreements in response to the failure of the Member concerned to implement the recommendations and rulings within that reasonable 
period of time. 
371. As the Appellate Body has explained, Article  23.1 lays down the fundamental obligation of 
WTO Members to have recourse to the rules and procedures of the DSU when seeking redress of a 
violation of the covered agreements.
780  Article 23 restricts WTO Members' conduct in two respects.  
First, Article 23.1 establishes the WTO dispute se ttlement system as the exclusive forum for the 
resolution of such disputes and re quires adherence to the rules of the DSU.  Secondly, Article 23.2 
prohibits certain unilateral action by a WTO Memb er.  Thus, a Member cannot unilaterally:  (i) 
determine that a violation has occurred, benefits  have been nullified or impaired, or that the 
attainment of any objective of the covered agreements  has been impeded;  ( ii) determine the duration 
of the reasonable period of time for implementation;   or (iii) decide to suspend concessions and 
determine the level thereof.   
372. The phrase "[i]n such cases, Members shall" with which Article 23.2 begins refers back to the 
situation described in Article 23.1, namely, when a Member is seeking the redress of, inter alia , a 
violation of obligations under th e covered agreements.  We shar e the view of the panel in US – 
Section 301 Trade Act  that the terms "[i]n such cases, Memb ers shall" used in the chapeau of 
Article 23.2 make clear that Article 23.2 is "explicitly  linked to, and has to be read together with and 
subject to, Article 23.1".781  Therefore, the specific prohibitions of unilateral actions in Article 23.2 
must be understood in the context of the overarching provision of Article 23.1.  In other words, the 
unilateral actions prohibited by Article 23.2 are those taken by a Member with a view to seeking 
redress of a violation.  Moreover, the phrase "[i]n such cases, Members shall" at the beginning of 
Article 23.2 indicates that the specific obligations set forth in its subparagraphs clarify and illustrate 
the scope of the general and ongoing obligation in Article 23.1.  This does not mean, however, that 
the scope of Article 23.1 is exhausted by the situations described in Article 23.2.782   
373. Seeking the redress of a violation is of course not by itself prohibited by Article 23.1 of the 
DSU.  Rather, to be in breach of Article 23.1, a Member must be seeking redress without having recourse to, or abiding by, the rules of the DSU.   
                                                     
 
780Appellate Body Report, US – Certain EC Products , para. 111. 
781Panel Report, US – Section 301 Trade Act , para. 7.44. 
782As the panel in US – Section 301 Trade Act  pointed out, the prohibitions mentioned in Article 23.2 
are examples of conduct that contradicts the rules and procedures of the DSU which, under the obligation in 
Article 23.1 to "abide by the rules and procedures" of the DSU, Members are obligated  to follow.  These rules 
and procedures cover more than those specifically mentioned in Article 23.2 and "[t]here is a great deal more State conduct which can violate the general obligation in Article 23.1 to have recourse to, and abide by, the rules 
and procedures of the DSU than the instances especially singled out in Article 23.2."  (Panel Report, US – 
Section 301 Trade Act , para. 7.45) (footnote omitted)  WT/DS321/AB/R 
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374. An initial question that arises in this case is wh ether the continued application of a previously 
authorized suspension of concessions can be said to  constitute the seeking of redress.  On the one 
hand, the authorization to suspend concessions can be said to be the result of a previous act of seeking 
redress that involved initiating a dispute.  On the other hand, the continued application of the 
suspension of concessions can be said to reflect a continuous act of seeking redress for a violation 
found by the DSB that has not yet been rectified.  In any event, the suspension of concessions that has 
been duly authorized by the DSB will not constitute a violation of Article 23.1, as long as it is 
consistent with other rules of the DSU, including paragraphs 2 through 8 of Article 22, even if the 
continued application of the suspension of concessions is regarded as an action or part of a process of 
"seeking the redress".  This is because, before  obtaining the DSB's authorization to suspend 
concessions, a Member must initiate a dispute settlement process in which it challenges the 
consistency with the covered ag reements of a measure taken by another Member.  The Member 
initiating the process will only be authorized to su spend concessions when the measure is found by 
the panel (and the Appellate Body, if appealed) to be inconsistent with the covered agreements and 
the Member taking the measure fails to implement th e panel's (or Appellate Body's) findings within a 
reasonable period of time or, if it takes a measure to comply, that measure is found by the panel (and 
the Appellate Body) in compliance proceedings not  to have brought the Member concerned into 
compliance.  In other words, the Member will only be able to suspend conc essions pursuant to the 
DSB's authorization after having had extensive recour se to, and abided by, the rules and procedures of 
the DSU, consistent with the requirements of Article 23.1. 
375.  This does not mean that Article 23.1 ceases to  apply once the suspension of concessions has 
been authorized by the DSB.  Artic le 23.2(c) specifically refers to Ar ticle 22 of the DSU.  Paragraph 8 
of this provision states that the suspension of con cessions shall only be app lied until the inconsistent 
measure has been removed or one of the other two conditions in Article 22.8 is met.  Thus, if the 
Member subject to the suspension of concessions ta kes an implementing measure and that measure is 
found in WTO dispute settlement proceedings to bri ng this Member into subs tantive compliance, the 
suspension of concessions would no longer be consis tent with Article 22.8 of the DSU, and, as a 
result, would become a unilateral action prohibited by Articles 23.1 and 23.2.  In other words, the 
requirements in Article 22.8 and Article 23 apply a nd must be read together in the post-suspension 
stage of a dispute.  Therefore, Article 23 must  be seen as containing an ongoing obligation and 
continues to apply even after the suspension of c oncessions has been duly authorized by the DSB.   
376. With this in mind, we turn to examine the i ssues raised by the United States and Canada on 
appeal. WT/DS321/AB/R 
Page 158  
 
2. The Panel's Alleged Examination of Ar ticles 23.2(a) and 23.1 in Isolation 
from the Requirements in Article 22.8 of the DSU  
377. The United States and Canada submit that th e Panel erred by examining the European 
Communities' claims under Articles 23.2(a), 23.1,  and 21.5 independently from the question of 
whether Article 22.8 required the termination of th e suspension of concessions.  The United States 
argues that the Panel ignored the fact that none of the conditions requiring the cessation of the 
suspension of concessions under Article 22.8 of th e DSU had occurred.  Thus, the United States 
maintains, the Panel's findings that the suspen sion of concessions by the United States is "without 
recourse to the procedures under the DSU"783 would effectively undermine the DSB's authorization to 
suspend concessions, rendering it "meaningless".784  Canada claims that the "[k]ey to this case is 
Article 22.8 of the DSU"785 which, as lex specialis  in the post-suspension phase of a dispute, sets out 
the three conditions that must be met in order to have the suspension of concessions terminated, one 
of the conditions being actual compliance with the DSB's recommendations and rulings.  Canada adds 
that "the continuous involvement of the DSB", pursuant to the second sentence of Article 22.8, 
"suggests that [the DSB] retains jurisdiction ove r the matter until its recommendations and rulings 
have been fully implemented."786  Thus, in Canada's view, the Pa nel should have first considered 
whether Canada was required to discontinue the suspension of concessions pursuant to Article 22.8.787  
378. We note that the suspension of concessions mainta ined by the United States and Canada were 
duly authorized by the DSB subsequent to its adoption of the recommendations and rulings in EC – 
Hormones  and an arbitration award resulting from pro ceedings under Article 22.6 regarding the level 
of the suspension of concessions.788  As discussed above, where th e suspension of concessions has 
been duly authorized by the DSB and is applied consistently with the rules of the DSU, including Article 22.8, it does not constitute a violation of  Article 23.1, because it is not imposed without 
recourse to or without abiding by the DSU.  The requirements in Article 22 and those in Article 23 
must be read together, in the post-suspension stage of the dispute, to determine the legality of the 
continued suspension when an implementing measure h as been taken.  Thus, we share the view of the 
United States and Canada that, in order to determine whether they acted inconsistently with Article 23 
by continuing the suspension of concessions subsequent to the notification of Directive 2003/74/EC, 
the Panel had to first determine whether the suspen sion of concessions was being applied consistently 
with Article 22.8 of the DSU. 
                                                     
 
783United States' other appellant's submission, para. 29. 
784Ibid., para. 30. 
785Canada's other appellant's submission, para. 35. 
786Ibid., para. 36. 
787Ibid., paras. 60 and 61. 
 788Article 22.4 provides that "[t]he level of the suspension of concessions or other obligations 
authorized by the DSB shall be equivalent to the level of the nullification or impairment."  WT/DS321/AB/R 
 Page 159 
 
 
379. The European Communities asserts that the United States and Canada "entirely ignore"789 the 
fact that the European Communities' first ser ies of main claims, alleging violations of 
Articles 23.1, 23.2(a), and 21.5, did not include Ar ticle 22.8 of the DSU.  The European Communities 
further contends that the Panel's approach in examining the claims under Articles 23.1 and 23.2(a) 
was correct, because Directive 2003/74/ EC, as a measure taken to comply, must be presumed to be 
compliant with the covered agreements until shown otherwise in Ar ticle 21.5 proceedings. 
380. In section D above, we found that the presumption that an implementing Member acts in good 
faith is insufficient to establish substantive co mpliance.  The European  Communities should be 
presumed to have acted in good faith when adopting the implementing measure;  however, this did not mean that the taking of such measure in itself establishes that the measu re achieves substantive 
compliance.  We also rejected the formalistic inte rpretation of Article 22.8 advanced by the European 
Communities that the adoption, and notification to th e DSB, of a measure taken to comply replacing 
the original measure is sufficient to  establish the removal of the measure found to be inconsistent with 
a covered agreement within the meaning of Arti cle 22.8.  Rather, a proper interpretation of 
Article 22.8, in its context and in the light of the object and purpose of the DSU, indicates that 
substantive compliance is required before the susp ension of concessions must be terminated.  Where 
parties disagree as to whether there is substan tive compliance, the duty to cease the suspension of 
concessions is not triggered until substantive comp liance is determined through multilateral dispute 
settlement proceedings.  A unilateral declaration of compliance cannot have the same effect.  We note 
that, as the original respondent, the European Co mmunities has the option to initiate Article 21.5 
panel proceedings for purposes of determining whet her the DSB's recommendations and rulings have 
been implemented through the adoption of Directive 2003/74/EC.  
381. The European Communities further submits th at, upon the adoption of Directive 2003/74/EC 
in good faith, the suspension of concessions would have achieved its objectiv e and would do nothing 
to induce compliance.  Article 22.1 of the DSU prov ides that the suspension of concessions is not to 
be "preferred to  full  implementation of a recommendation to br ing a measure into conformity with 
the covered agreements".
790  Requiring termination of the suspension of concessions simply because a 
Member declares that it has rem oved the inconsistent measure, w ithout a multilateral determination 
that substantive compliance has i ndeed been achieved, would undermine the important function of the 
suspension of concessions in inducing compliance.  This would significantly weaken the effectiveness 
                                                      
789European Communities' appellee's submission, para. 29.  
790Moreover, pursuant to Article 3.3, the "prompt settlement" of disputes "is essential to the effective 
functioning of the WTO and the maintenance of a proper balance between the rights and obligations of 
Members". WT/DS321/AB/R 
Page 160  
 
of the WTO dispute settlement system and its abili ty to provide security and predictability to the 
multilateral trading system.  
382. The European Communities additionally submits that its position is consistent with the 
approach taken in the Articles on Responsibility of States for Internationally Wrongful Acts
791 (the 
"Articles on State Responsibility"), which require  that countermeasures be suspended if the 
internationally wrongful act has ceased and the dis pute is pending before a tribunal that has the 
authority to make decisions binding upon the parties.792  Yet, the Articles on State Responsibility do 
not lend support to the European Communities' po sition.  For example, Article 53 provides that 
countermeasures must be terminated as soon as the State "has complied with its obligations" in relation to the internationally wrongful act.  Thus , relevant principles under international law, as 
reflected in the Articles on State Responsibility,  support the proposition that countermeasures may 
continue until such time as the responsible State h as ceased the wrongful act by fully complying with 
its obligations. 
383. In sum, the suspension of concessions maintain ed by the United States and Canada has been 
duly authorized by the DSB and was obtained through recourse to the relevant rules and procedures of 
the DSU, consistently with Article 23.1 of the DSU.   Pursuant to Article 22.8, the legality of the 
continued suspension of concessions depends on whet her the measure found to be inconsistent in 
EC – Hormones has been removed, and this requires subs tantive compliance.  We therefore find
 that 
the Panel erred in considering that the European  Communities' claims under Articles 23.2(a), 23.1, 
and 21.5 may be examined "completely separat ely" from whether the European Communities 
implemented the DSB's recommendations and rulings in EC – Hormones .793 
384. The DSB's authorization does not mean that Article 23 becomes irrelevant.  Rather, as 
Article 23.2(c) specifies, the suspension of concessions is subject to Article 22, including the requirement in Article 22.8 that it shall only be applied until such time as the measure found to be 
inconsistent with the covered agreements has been removed.  Therefore, the suspension of 
concessions by the United States and Canada would be in breach of Article 23. 2(c), and consequently 
Article 23.1, if it were established in WTO dispute se ttlement that the inconsistent measure has indeed 
been removed within the meaning of Article 22.8 a nd the suspension is not immediately terminated.  
Article 22.8 thus provides relevant context for the analysis of the issues appealed under Article 23.  
Moreover, the application of DSB-authorized susp ension of concessions is temporary and subject to 
the objective conditions laid down in Article 22. 8.  The United States, Canada, as well as the 
                                                     
 
791See supra , footnote 481. 
792See European Communities' appellee's submission, paras. 94-96. 
793Panel Report, US – Continued Suspension , para. 7.182;  Panel Report, Canada – Continued 
Suspension , para. 7.164.  WT/DS321/AB/R 
 Page 161 
 
 
European Communities, have the shared responsibility  to ensure that the suspension of concessions is 
not applied beyond the time foreseen in Article 22. 8.  Consequently, the United States and Canada 
have a duty to engage actively in dispute settleme nt proceedings concerning whether the suspension 
of concessions is applied consistently with such c onditions.  Failing to do so co uld be contrary to the 
overarching principle in Article 23.1 prohibiti ng Members from seeking redress without having 
recourse to, or abiding by the rul es of, the DSU.  Nonetheless, this is not currently the case, because 
both the United States and Canada are actively engage d in these proceedings initiated by the European 
Communities to determine whether the measure found to  be inconsistent with a covered agreement in 
EC – Hormones  has been removed within the meaning of Article 22.8. 
3. Whether the Panel Erred in Finding th at the United States and Canada Are 
"Seeking the Redress of a Violation" with Respect to Directive 2003/74/EC  
385. We turn to examine the claim by the United Stat es and Canada that the Panel erred in finding 
that, by continuing the susp ension of concessions subseque nt to the notification of 
Directive 2003/74/EC, they were seeking the redres s of a violation without having recourse to, or 
abiding by, the rules and procedures of the DSU within the meaning of Article 23.1 of the DSU. 
386. The Panel found that Directive 2003/74/EC, wh ich the European Communities adopted to 
implement the DSB's recommendations and rulings in  EC – Hormones , is a new measure that "has 
never been as such subject to recourse to the rules and procedures of the DSU".794  The Panel stated 
that, although Directive 2003/74/EC, like Directive 96/22/EC (which was found to be WTO-
inconsistent in  EC – Hormones ), also imposed an import ban, "it is not the ban ... but the justification 
for this ban which was found insufficient" in  EC – Hormones .795  According to the Panel, therefore, 
the fact that the ban remains in place does not me an that no new measure has been adopted.  The 
Panel thus found that, through the continued suspen sion of concessions, the United States and Canada 
are seeking redress of a violation caused by Dir ective 2003/74/EC, a measure they had not challenged 
by having recourse to the DSU.796  
387. We recall that the suspension of concessions ma intained by the United States and Canada was 
authorized by the DSB as a result of the finding in  EC – Hormones  that Directive 96/22/EC was 
inconsistent with the  SPS Agreement .  The Panel correctly noted that the existence of an import ban 
in Directive 2003/74/EC (which replaced Directive 96/22/EC) does not mean that no implementing 
                                                      
794Panel Report, US – Continued Suspension , para. 7.206;  Panel Report, Canada – Continued 
Suspension , para. 7.198. 
795Panel Report, US – Continued Suspension , para. 7.207; Panel Report, Canada – Continued 
Suspension , para. 7.199. 
796Panel Report, US – Continued Suspension , para. 7.215;  Panel Report, Canada – Continued 
Suspension , para. 7.207. WT/DS321/AB/R 
Page 162  
 
measure has been adopted.  Yet, the Panel's anal ysis under Article 23 stopped short of considering 
whether the European Communities' implementing m easure resulted in substantive compliance.  As 
we explained earlier, such analysis is necessary to determine whether the suspension of concessions 
was required to be terminated pursuant to Article 22.8 of the DSU.  Even if the United States and 
Canada could be said to continue to seek redress of the violation resulting from Directive 96/22/EC by 
maintaining the suspension of concessions, they  are not prevented from doing so as long as the 
removal of the inconsistent measure has not b een established in WTO dispute settlement.  In 
obtaining DSB authorization for that suspension, th e United States and Canada abided by the DSU as 
required by Article 23.1.  The Pa nel's finding that, by maintaini ng the suspension of concessions, the 
United States and Canada are seeking the redress of a violation without abiding by the rules of the DSU thus appears to presuppose what is yet to be es tablished, that is, that the inconsistent measure 
against which the suspension of concessions was authorized (Directive 96/22/EC) has actually been 
"removed" within the meaning of Article 22.8 by Directive 2003/74/EC.
797  This finding of the Panel 
flows from its erroneous approach of consideri ng Articles 23.1 and 23.2(a) completely separately 
from the requirements of Article 22.8, which we discussed and rejected earlier. 
388. The Panel rejected the arguments by the United States and Canada that they were authorized 
to suspend concessions and that this authorization has not been revoked.798  The Panel stated that the 
DSB's authorization to suspend concessions is "only an  authorization , not an obligation ".799  
According to the Panel, this meant that the Un ited States and Canada were "free to apply" the 
suspension of concessions or not, and the fact that th ey did not lift the suspension after the notification 
of Directive 2003/74/EC indicated their inten tion to seek redress of a violation arising from 
Directive 2003/74/EC.800  We fail to see the relevance of the distinction between an authorization and 
an obligation to suspend concessions for purposes of  analyzing whether the United States and Canada 
are seeking the redress of a violation concerning Di rective 2003/74/EC.  The relevant question before 
the Panel was whether the authorization to susp end concessions had lapsed because one of three 
conditions in Article 22.8 has been met.  In the ab sence of a finding in WTO dispute settlement that 
                                                      
797In the context of addressing the European Communities' claim that the United States and Canada 
also breached Article 22.8, the Panel found that "it has not been established that the European Communities has 
removed the measure found to be inconsistent with a covered agreement." (Panel Report, US – Continued 
Suspension , para. 7.847; and Panel Report, Canada – Continued Suspension , para. 7.832)  For this reason, the 
Panel concluded that the European Co mmunities "did not demonstr ate a breach of Article 22.8 of the DSU" by 
the United States and Canada.  (Panel Report, US – Continued Suspension , para. 7.850;  Panel Report, Canada – 
Continued Suspension , para. 7.835)   
798Panel Report, US – Continued Suspension , para. 7.208;  Panel Report, Canada – Continued 
Suspension , para. 7.200. 
799Panel Report, US – Continued Suspension , para. 7.209;  Panel Report, Canada – Continued 
Suspension , para. 7.201. (original emphasis) 
800Panel Report, US – Continued Suspension , paras. 7.209 and 7.210;  Panel Report, Canada – 
Continued Suspension , paras. 7.201 and 7.202.  WT/DS321/AB/R 
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the first condition in Article 22.8 had been met, th e authorization to suspend concessions did not cease 
to be legally valid. 
389. In addition, the Panel observed that "[i]n none of the circumstances foreseen by [the first 
sentence of] Article 22.8 does this provi sion require a decision of the DSB".801  We agree that, under 
the first sentence of Article 22.8, a decision of the DSB is not required if Members reach a mutually agreed solution.  Similarly, a DSB decision is not required if the suspending Member does not dispute 
that the measure found to be inconsistent with a covered agreement has b een removed.  However, 
where a disagreement arises as to whether the measure found to be inconsistent has indeed been 
removed, this disagreement must be resolved thro ugh Article 21.5 proceedings to determine whether 
the suspension of concessions is still applied consistently with the objective conditions under 
Article 22.8 or must be terminated.  Under such circumstances, DSB decisions are required for the 
dispute to proceed pursuant to the rules of the DS U, including the decision to establish a panel and the 
adoption of the panel or Appellate  Body reports examining the implem enting measure.  Moreover, the 
second sentence of Article 22.8 requires the DSB to  keep under surveillance the implementation of 
adopted recommendations and rulings in cases where c oncessions have been suspended.  Article 22.8 
therefore clearly contemplates an ongoing role of the DSB in reviewing the implementation of 
recommendation and rulings, thus confirming that  a dispute concerning implementation should be 
subject to multilateral resolution and not be deci ded on the basis of a unilateral declaration of 
compliance or non-compliance. 
390. We also note the Panel's statement that , "pursuant to Article XVI:4 of the [ WTO Agreement ], 
Members must ensure the conformity of their laws, regulations and administrative procedures with their obligations as provided" in the covered agreements, "including the DSU".
802  According to the 
Panel, this obligation also applies to the suspensi on of concessions.  Article XVI:4 applies equally to 
all WTO Members.  The European Communities w as required to ensure the conformity of its 
implementing measure, just as it is the obligation of the United States and Canada to ensure the 
conformity of their continued app lication of suspension of concessions.803  We do not see the 
relevance of this provision in the Panel's anal ysis under Article 23.1 of the DSU, as long as the 
conditions for the cessation of suspension unde r Article 22.8 have not been established. 
                                                      
801Panel Report, US – Continued Suspension , para. 7.211;  Panel Report, Canada – Continued 
Suspension , para. 7.203. 
802Panel Report, US – Continued Suspension , para. 7.212;  Panel Report, Canada – Continued 
Suspension , para. 7.204. 
803As the United States argues, this provision "militates equally in favor of a finding that the continued 
suspension of concessions by the United States" after the European Communities' notification of Directive 2003/74/EC "did   not  demonstrate that the United States was 'seeking redress of a violation' within 
the meaning of Article 23.1 with respect to" this Directive.  (United States other appellant's submission, 
para. 58) (original emphasis) WT/DS321/AB/R 
Page 164  
 
391. On appeal, the European Co mmunities submits that "the adoption  of a measure taken to 
comply" that is " different  from the original [measure] triggers  the presumption of good faith 
compliance" and, consequently, the "obligati on to remove the suspension of concessions".
804  T h e  
European Communities' argument is again prem ised on the proposition that the implementing 
measure should be presumed to bring about full co mpliance as a result of the application of the 
presumption of good faith, as well as its understanding of the phrase "the measure found to be 
inconsistent with a covered agreement has been re moved" in Article 22.8 as requiring merely the 
formal removal of the original measure, bot h of which we rejected in section D.   
392. The European Communities further asserts that  "even the United States acknowledged that it 
was maintaining its suspension of concessions agai nst the new measure", as demonstrated by the 
United States' statements at the DSB meetings sub sequent to the notification of Directive 2003/74/EC 
and in its Trade Policy Agenda in 2005.805  As will be discussed in subsection 4 below, the DSB 
statements referred to by the European Communities do not, in themselves, have the legal effects that 
the Panel attributed to them.  Moreover, the Trade Policy Agenda document referred to by the 
European Communities states that the United Stat es "maintains its WTO-authorized sanctions on 
[European Communities'] products because the United States fails to see how the revised [European 
Communities'] measure could be considered to im plement the recommendations and rulings of the 
DSB in this matter".806  Thus, contrary to the European Communities' arguments, the statements make 
clear that the legal basis for maintaining the su spension of concessions was not the new measure.  
Rather, the basis for maintaining the suspension of concessions was that the United States considered 
that the European Communities had failed to impl ement the DSB's recommendations and rulings in 
EC – Hormones flowing from the inconsistency of Directive 96/22/EC.   
393. Accordingly, we find  that the Panel erred in concluding that, "by maintaining the suspension 
of concessions even after the notification of [D irective 2003/74/EC]", the United States and Canada 
are "seeking redress of a violation with respect to [t his Directive], within the meaning of Article 23.1 
of the DSU".807 
                                                      
804European Communities' appellee's submission, para. 104. (original emphasis) 
805Ibid., para. 106 (referring to Panel Report, US – Continued Suspension , paras. 7.219-7.221). 
806Ibid. 
807Panel Report, US – Continued Suspension , para. 7.215;  Panel Report, Canada – Continued 
Suspension , para. 7.207.  WT/DS321/AB/R 
 Page 165 
 
 
4. Whether the Panel Erred in Finding that  the United States and Canada Made 
a Determination of Violation Without Recourse to the DSU, Within the 
Meaning of Article 23.2(a)  
394. We turn now to review the claims by the United States and Canada that the Panel erred in 
finding that they made a determination of viol ation regarding Directive 2003/74/EC without having 
recourse to dispute settlement in accordance with th e rules and procedures of the DSU, contrary to 
Article 23.2(a) of the DSU. 
395. We recall that, on the basis of the statements made by Canadian and United States delegates 
at two DSB meetings808 concerning Directive 2003/74/EC, the Panel concluded that the United States 
and Canada had reached "a more or less final decision"809 that this Directive is inconsistent with the 
SPS Agreement   and fails to implement the DSB's recommendations and rulings in EC – Hormones .  
Such statements, in the Panel's view, constitute a "determination" under Article 23.2(a) of the DSU 
and, because the determination was made unilatera lly without recourse to the DSU, it breached 
Article 23.2(a).810   
396. We share the view of the panel in US – Section 301 Trade Act  that a "determination" within 
the meaning of Article 23.2(a) "implies a high degree of firmness or immutability, i.e. a more or less 
final decision by a Member in respect of the WTO consistency of a measure taken by another 
Member".811  Moreover, preliminary opinions or views expressed without a clear intention to seek 
redress are not covered by Article 23.2(a).812  The statements made by delegates of the United States 
and Canada, on which the Panel fo cused its attention, were made shortly after the European 
Communities notified Directive 2003/74/EC to the DSB.   The statements were made at the two DSB 
meetings held, respectively, two weeks and five weeks from the DSB meeting at which 
Directive 2003/74/EC was notified by the European Communities.813  These statements, therefore, 
seem no more than initial reactions to the Europ ean Communities' self-proclaimed compliance with 
the DSB's recommendations and rulings in EC – Hormones .  Considering the complexity of the issues 
                                                      
808See Panel Report, US – Continued Suspension , paras. 7.219 and 7.220 (quoting Minutes of the DSB 
Meetings held on 7 Novemb er and 1 December 2003, WT/DSB/M/157, paras. 29 and 30, and WT/DSB/M/159, 
para. 25, respectively);  and Panel Report, Canada – Continued Suspension , paras. 7.211-7.213 (quoting 
Minutes of the DSB Meetings held on 7 November  and 1 December 2003, WT/DSB/M/157, para. 31, and 
WT/DSB/M/159, para. 24, respectively). 
809Panel Report, US – Continued Suspension , para. 7.222;  Panel Report, Canada – Continued 
Suspension  , para. 7.215 (quoting Panel Report, US – Section 301 Trade Act , footnote 657 to para. 750). 
810Panel Report, US – Continued Suspension , paras. 7.225 and 7.226;  Panel Report, Canada – 
Continued Suspension , paras. 7.219, 7.222, and 7.223. 
811Panel Report, US – Section 301 Trade Act , footnote 657 to para. 7.50. 
812See ibid..  See also Panel Report, US – Certain EC Products , para. 6.18. 
813The European Communities notified the DSB of the adoption of Directive 2003/74/EC on 27 
October 2003.  See Panel Report, US – Continued Suspension , para. 7.219;  and Panel Report, Canada – 
Continued Suspension , para. 7.211. WT/DS321/AB/R 
Page 166  
 
that arise with respect to the consistency of Di rective 2003/74/EC (as demonstrated in sections VI 
and VII of the Report), it is reasonable to assume th at the United States and Canada needed some time 
before forming a definitive view regarding whethe r the European Communities had brought itself into 
compliance.  We thus share the United States' and Canada's view that the statements at the DSB 
meetings lack sufficient amount of "firmness or im mutability" for them to constitute a determination 
within the meaning of Article 23.2(a).
814   
397. In their statements, the United States and Cana da indicated that they would be willing to 
engage in further bilateral discussions rega rding the alleged scientific justification for 
Directive 2003/74/EC.815  This readiness to discu ss Directive 2003/74/EC is difficult to reconcile with 
a finding that the DSB statements constituted a "d etermination" with the type of firmness and 
immutability required by its ordinary meaning and the relevant context of Article 23, as interpreted by 
the panel in US – Section 301 Trade Act .  The Panel recognized this inte ntion to engage in bilateral 
discussions evidenced in the DSB statements, but f ound that the consultations that took place after the 
notification of Directive 2003/74/EC "lar gely related to procedural issues".816  Simply because 
subsequent consultations re lated largely to procedural issues does not mean that, at the time the DSB 
statements were made , the United States and Canada had made  a unilateral determination without 
recourse to the DSU within the meaning of Article 23.2(a). 
398. Moreover, DSB statements are not intended to have legal effects and do not have the legal 
status of a definitive determination in themselves.   Rather, they are views expressed by Members and 
should not be considered to prejudice Members' positi on in the context of a dispute.  As the United 
States rightly points out, "[s]tatements made by Members at DSB meetings, especially those 
                                                      
814United States' other appellant's submission, paras. 79-81;  Canada's other appellant's submission, 
para. 89.  Canada adds that the statements made at the two DSB meetings were "the equivalent of Canada 
reserving its rights while not acquiescing to the [European Communities'] assertions of compliance".  ( Ibid.)  
We consider this a proper char acterization of these statements. 
815Panel Report, US – Continued Suspension , para. 7.220;  Panel Report, Canada – Continued 
Suspension , para. 7.212.  The United States indicated at th e meeting of 1 December 2003 that "[t]he United 
States would be pleased to discuss with [European Co mmunities'] officials any outstanding issues regarding the 
[European Communities'] ban on certain  beef produced in the United Stat es, including their reactions to the 
detailed points that the United States had raised in its statement at the 7 November DSB meeting.  With regard 
to the suggestion made by the [European Communities] at the present meeting that multilateral proceedings be 
initiated, the United States would be happy to discu ss this suggestion with the [European Communities] along 
with other procedural options." (Panel Report, US – Continued Suspension , para. 7.220)  Canada indicated at the 
meeting of 7 November 2003 that "Canada did not see any reason for WTO procedures at this time, but would 
welcome the opportunity for further discussion with the [European Communities] concerning the justification for its measures." (Panel Report, Canada – Continued Suspension , para. 7.211)  
816Panel Report, US – Continued Suspension , para. 7.224;  Panel Report, Canada – Continued 
Suspension , para. 7.222.  WT/DS321/AB/R 
 Page 167 
 
 
expressing a view as to the WTO consistency of anot her Member's measures or actions, are generally 
diplomatic or political in nature" and "generally have  no legal effect or status in and of themselves".817   
399. The Panel's finding that DSB statements could constitute a definitive determination 
concerning the WTO-inconsistency of a Member's measure could adversely affect WTO Members' 
ability to freely express their views on the potential  compatibility with the covered agreements of 
measures adopted by other Members.818  This would result in a "chilling" effect on those 
statements819, because Members would refrain from expressing their views at DSB meetings regarding 
the WTO-inconsistency of other Members' measures lest such statements be found to constitute a 
violation of Article 23.  If this were the case, the DSB would be inhibite d from properly carrying out 
its function, pursuant to Article 21.6 of the DSU, to keep under surveillance the implementation of its 
recommendations and rulings. 
400. The European Communities disagre es with the United States' argument that statements made 
at DSB meetings have no legal effect in themselv es, arguing, instead, that "those statements can be 
used as  evidence  of a particular position, view or  determination taken by a Member."820  T h e  
European Communities refers to th e Appellate Body's observation in US – Upland Cotton 
(Article 21.5 – Brazil)  that certain statements in a United States Government press release indicated 
that it was taking a measure to comply with the DSB's recommendations and rulings.821  T h e  
European Communities' reliance on th e Appellate Body's findings in US – Upland Cotton 
(Article 21.5 – Brazil) is misplaced.  In that dispute, the Appellate Body did not rely on the press 
release of the United States Government in making a finding on the scope of the "measure taken to 
comply", but only referred to the statements of th e United States' officials as providing confirmation 
of its earlier conclusion, reached on the basis of an examination of the measure itself and the DSB's 
recommendations and rulings in the or iginal dispute.  In contrast, the Panel in this dispute based its 
finding that the United States and Canada made a dete rmination of violation directly on the statements 
they made at the DSB.  
                                                      
817United States' other appellant's submission, para. 93. 
818We note the United States' concern that "[t]he Panel has thereby made the bold and novel move of 
transforming the minutes of DSB, other WTO committee meetings, and even Trade Policy Review meetings 
into a fertile source of comments that ... could constitu te 'determinations' actionable under Article 23.2(a)." 
(Ibid., para. 94) 
819Ibid., para. 95. 
820European Communities' appellee's submission, para. 131. (original emphasis) 
821Ibid. (referring to Appellate Body Report, US – Upland Cotton (Article 21.5 – Brazil) , para. 204). WT/DS321/AB/R 
Page 168  
 
401. We agree therefore with the United States and Canada that their statements at the DSB 
meetings did not involve the degree of firmness or  immutability necessary in order to constitute a 
"determination" within the meaning of Article 23 of the DSU.
822   
402. The Panel went on to find that, even if the DSB statements were considered to be provisional, 
"the subsequent continuation of the suspension of concessions by [the United States and Canada] 
without alteration and without saying that [t hey were] still studying [Directive 2003/74/EC]" 
confirmed that they made such a "determination".823  The United States and Canada submit that the 
Panel "inferred"824, or "construed"825 the existence of a determination on the basis of the mere 
continuation of the suspension of concessions.  Th ey argue that the Panel's reasoning is flawed 
because it draws an inference from the "inaction"826, or "non-feasance"827, of the United States and 
Canada in failing to terminate the suspension of concessions.   
403. As we stated earlier, the DSB authorization of the suspension of concessions by the United 
States and Canada flowed from the inconsistency of Directive 96/22/EC and continued to be legally 
valid until the measure found to be incons istent with a covered agreement in EC – Hormones  was 
removed within the meaning of Article 22.8.  A lthough the European Communities may have claimed 
to have removed the inconsistent  measure and declared compliance, the United States and Canada 
disagreed that this was in fact the case.  T hus, until the removal of the European Communities' 
inconsistent measure was determined through WTO dispute settlement, the United States' and 
Canada's authorization to suspend concessions di d not lapse.  Under these circumstances, the 
suspension of concessions applied pursuant to  the DSB's authorization in respect of 
Directive 96/22/EC was maintained through recourse to, and abiding by, the rules and procedures of 
the DSU.  Its continuation thus did not "confirm" that the United States and Canada made a unilateral 
determination regarding Directive 2003/74/EC, as the Pa nel found, in violation of Article 23.2(a) of 
the DSU.828  
                                                      
822United States' other appellant's submission, para . 96;  Canada's other appellant's submission, 
para. 89. 
823Panel Report, US – Continued Suspension , para. 7.230;  Panel Report, Canada – Continued 
Suspension , para. 7.224. 
824United States' other appellant's submission, para. 98. 
825Canada's other appellant's submission, para. 81. 
826United States' other appellant's submission, para. 98. 
827Canada's other appellant's submission, para. 81. 
828Nonetheless, we do not share the view of the United States and Canada that the continued suspension 
of concessions should be properly characterized as inaction.  Upon the authorization to suspend concessions 
in 1999, the United States and Canada respectively took th e measures to impose tariffs on all imports of certain 
European Communities products at rates substantially exceeding the bound tariff rates and have continuously 
collected the additional tariffs since then.  Thus, the continued suspension of concessions by the United States 
and Canada is more properly characterized as an ongoing action.    WT/DS321/AB/R 
 Page 169 
 
 
404. The United States further asserts that, by inferring the existence of a "determination" within 
the meaning of Article 23.2(a) on the basis of the continued suspension of concessions, the Panel 
effectively read into Article 23 a deadline by wh ich a unilateral determinat ion inconsistent with 
Article 23.2(a) will be imputed to a Member, ev en though Article 23 contains no such deadline.829  
The European Communities contends that the Pane l correctly observed that the deadline by which a 
Member shall have recourse to the DSU pursuant to Articles 23.1 and 23.2(a) "was not an issue before 
the Panel".830  However, without a proper identification of  the time at which the continued suspension 
of concessions would be found to constitute a unilate ral determination inconsistent with the DSU, 
WTO Members would be unsure as to when or for how long they could properly rely on a DSB authorization to suspend concessions.  Such an outcome is contrary to the DSU's objective of 
providing security and predictability.
831  In any event, given that we have found above that an original 
respondent may initiate Article 21.5 proceedings, and that the authorit y to suspend concessions lapses 
once one of the three conditions in Article 22.8 is met, we feel no need to further explore this 
question. 
405. Thus, we conclude  that the Panel erred in finding that  the United States and Canada "made a 
'determination' within the meaning of Article 23.2( a) in relation to Directive 2003/74/EC" on the basis 
of statements made at DSB meetings and the fact that the suspension of concessions continued subsequent to the notification of Directive 2003/74/EC.
832   
406. Having found that the United States and Canada ma de a determination of violation in relation 
to Directive 2003/74/EC, the Panel went on to find  that, because "the authorization to suspend 
concessions" does not amount to "a multilate ral determination of inconsistency"833 of 
Directive 2003/74/EC, the United States and Canada ha d not made the determin ation through recourse 
to dispute settlement in accordance with  the rules and procedures of the DSU.834  However, whether 
Directive 2003/74/EC "removed" the inconsistencies w ithin the meaning of Article 22.8 was disputed 
and had not yet been determined through WT O dispute settlement.  Therefore, the DSB's 
authorization remained valid.  The Panel's finding al so contradicts its own approach, correctly taken 
in the context of its examination of Article 22.8, th at the suspension of concessions is not required to 
                                                      
829United States' other appellant's submission, para. 105. 
830European Communities' appellee's submission, para. 134 (referring to Panel Report, US – Continued 
Suspension , para. 7.232). 
831See Canada's other appellant's submission, para. 81. 
832Panel Report, US – Continued Suspension , para. 7.239;  Panel Report, Canada – Continued 
Suspension , para. 7.232. 
833Panel Report, US – Continued Suspension , para. 7.242;  Panel Report, Canada – Continued 
Suspension , para. 7.235. 
834Panel Report, US – Continued Suspension , para. 7.243;  Panel Report, Canada – Continued 
Suspension , para. 7.236. WT/DS321/AB/R 
Page 170  
 
be terminated merely on the basis of a formal re moval of the inconsistent  measure but, rather, is 
required once there is substantive compliance. 
407. Because we have found that the Panel erred in  concluding that the United States and Canada 
made a determination that a violation has occurred within the meaning of Article 23.2(a), the Panel's 
finding that the United States and Canada had "failed to make any such determ ination consistent with 
the findings contained in the panel or Appellate Bo dy report adopted by the DSB or an arbitration 
award rendered under the DSU", in breach of Article 23.2(a)
835, also fails. 
5. Conclusion  
408. We concluded in the preceding sections that the Panel erred in finding that the United States 
and Canada were seeking the redress of a violation with respect to Directive 2003/74/EC, within the 
meaning of Article 23.1 of the DSU, and made a de termination in relation to that Directive to the 
effect that a violation has occurred, within the mean ing of Article 23.2(a) of the DSU.  Therefore, we 
reverse  the Panel's finding that the United States and Canada have "vio lated Article[s] 23.1 
and 23.2(a) of the DSU by seeking redress of  violation of the WTO Agreement through a 
determination that the [European Communities'] im plementing measure did not comply with the DSB 
recommendations and rulings in the EC – Hormones  case without having recourse to dispute 
settlement in accordance with the ru les and procedures of the DSU."836 
409. The European Communities claims that, in order to fulfil their obligations under Articles 23.1 
and 23.2(a) of the DSU to have recourse to disput e settlement in accordance with the DSU, the United 
States and Canada were required to initiate Article 21.5 panel proceedings if they considered that 
Directive 2003/74/EC fails to bring the European  Communities into compliance.  The European 
Communities submits that, upon finding that the Unite d States and Canada breached Articles 23.2(a) 
and 23.1 by seeking the redress of a violation withou t recourse to the DSU, the Panel should have also 
found that the United States and Canada breached Ar ticle 21.5 by failing to initiate panel proceedings 
under that provision.  We have reversed the Pa nel's finding that the United States and Canada 
breached Articles 23.2(a) and 23.1 by seeking the redress of a violation without recourse to the DSU.  
We also recall our earlier finding that the origin al respondent is not precluded under Article 21.5 from 
initiating Article 21.5 compliance proceed ings.  Consequently, we dismiss  the European 
Communities' claim.  This does not mean that the Un ited States and Canada do not have an obligation 
to engage in the dispute settlement procedures in an cooperative manner.  Rather, the United States, 
                                                      
835Panel Report, US – Continued Suspension , para. 7.244;  Panel Report, Canada – Continued 
Suspension , para. 7.237. 
836Panel Report, US – Continued Suspension , para. 7.251;  Panel Report, Canada – Continued 
Suspension , para. 7.244.  WT/DS321/AB/R 
 Page 171 
 
 
Canada, and the European Communitie s have an obligation to engage in Article 21.5 proceedings in 
order to obtain objective ascertainment of whether s ubstantive compliance has been achieved in this 
case and whether the resolutive condition  in Article 22.8 has been met. 
G. The Panel's Finding that It Had No Jurisdiction to Make Findings under the SPS 
Agreement 
410. The United States and Canada request that, s hould the Appellate Body uphold the Panel's 
findings that they breached Articles 23.2(a) and 23.1 of the DSU, it reverse the Panel's statement, in 
the last paragraph of its Report, that it had no jurisdiction to determine the compatibility of 
Directive 2003/74/EC with the  SPS Agreement .837  Because we have reversed the Panel's finding that 
the United States and Canada breached Articles 23. 2(a) and 23.1 of the DSU, the condition upon 
which the United States' and Canada's requests rest is not met.  We note, however, that in section D.4 
above we upheld the Panel's finding that "it has ju risdiction to consider the compatibility of the 
[European Communities'] implementing measure with the  SPS Agreement  as part of its review of the 
claim raised by the European Communities w ith respect to Article 22.8 of the DSU."838  In any event, 
in sections VI and VII below, we reverse the Pa nel's findings under Articles 5.1 and 5.7 of the SPS 
Agreement .   
H. The Panel's Suggestion 
411. In addition to finding that the United States and Canada committed procedural violations 
under Article 23 of the DSU, the Panel suggested, pursu ant to Article 19.1 of the DSU, that the United 
States and Canada "should have recourse to the ru les and procedures of the DSU without delay".839  
The European Communities, the United States, and Ca nada all take issue with  this suggestion.   
412. The United States and Canada request that, in th e event that the Appellate Body upholds the 
Panel's finding that the United States and Ca nada committed procedural violations under 
Articles 23.2(a) and 23.1 of the DSU, the Appellate  Body reverse the Panel's suggestion that they 
should have recourse to the DSU without delay.840 
413. The European Communities contends that the Pa nel's suggestion, that the United States and 
Canada should have recourse to dispute settlement without delay, is "too vague to be of much 
                                                      
837United States' other appellant's submission, paras. 108 and 120;  Canada's other appellant's 
submission, para. 92. 
838Panel Report, US – Continued Suspension , para. 7.379;  Panel Report, Canada – Continued 
Suspension , para. 7.376. 
839Panel Report, US – Continued Suspension , para. 8.3;  Panel Report, Canada – Continued 
Suspension , para. 8.3. 
840United States' other appellant's submission, paras. 108 and 116;  Canada's other appellant's 
submission, paras. 92 and 98. WT/DS321/AB/R 
Page 172  
 
assistance", because it is unclear to  "which rules and procedures of the DSU" the United States and 
Canada should have recourse.
841  Therefore, the European Communities requests the Appellate Body 
to "improve the Panel's suggestion in order to bring it into a clear form that is also more in line with 
the Panel's own findings".842  More specifically, the European  Communities requests the Appellate 
Body to "modify" the suggestion so as to make clear that the United States and Canada should:  (i) cease applying the suspension of concessions;  and (ii) seek resolution of any disagreement 
regarding the consistency of Di rective 2003/74/EC through rec ourse to panel proceedings under 
Article 21.5 of the DSU, or any other dispute se ttlement proceedings that the parties may agree.
843   
414. The Panel's suggestion that the United States a nd Canada "should have recourse to the rules 
and procedures of the DSU without delay" rests on its findings that the United States and Canada breached Articles 23.2(a) and 23.1 of the DSU by  seeking redress of a viol ation of the covered 
agreement without having recourse to dispute settle ment under the DSU.  We have reversed these 
findings of the Panel.  Thus, the Panel's suggestion cannot stand. 
V. Due Process in the Panel's Consultations with the Scientific Experts 
415. We now turn to the European Communities' cl aims that the Panel failed to respect the 
principle of due process and, consequently, also fa iled to make an objective assessment of the matter 
under Article 11 of the DSU, in selecting and relyin g upon two of the scientific experts consulted by 
the Panel.   
A. The Panel's Findings 
416. On 25 November 2005, following consultation with  the parties, the Panel adopted Working 
Procedures for Consultations with Scientific a nd/or Technical Experts (the "Experts Working 
Procedures").
844  The Panel decided not to establish an expe rt review group as had been suggested by 
the European Communities, but to co nsult experts on an individual basis.845  Moreover, the Panel 
"sought information not only from selected experts but  also from three relevant international entities, 
                                                      
841European Communities' appellant's submission, para. 479. 
842Ibid. 
843Ibid., para. 480. 
844Panel Report, US – Continued Suspension , para. 7.71;  Panel Report, Canada – Continued 
Suspension , para. 7.69.  The Experts Working Procedures are reproduced in Annex A-5 of the Panel Reports.  A 
single expert selection process was carried out for both disputes.  (Panel Report, US – Continued Suspension , 
para. 7.76;  Panel Report, Canada – Continued Suspension , para. 7.74) 
845Panel Report, US – Continued Suspension , para. 7.71;  Panel Report, Canada – Continued 
Suspension , para. 7.69.  The European Communities initially indicated that the Panel did not have to consult 
experts. (Panel Report, US – Continued Suspension , para. 7.56;  Panel Report, Canada – Continued Suspension , 
para. 7.54)  WT/DS321/AB/R 
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the Codex Alimentarius Commission (Codex), the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA), and the International Agency for Research on Cancer (IARC)."846 
417. In accordance with paragraph 3 of the Expe rts Working Procedures, the Panel solicited 
suggestions for experts from the Secretariats of Codex, JECFA, and the IARC.847  From these 
suggestions, the Panel provided to the parties all the information received from the 11 experts that 
were interested and available, and asked them to indicate any "compelling reasons" why particular 
experts should not be chosen.848  The European Communities objected to the inclusion of experts that 
had participated in JECFA's risk assessment work, e xplaining that "the scientific controversy over the 
JECFA reports is at the heart of this case and is  the reason why the Panel is now seeking advice from 
outside experts."849  The European Communities added that such  experts "cannot be considered to be 
objective and impartial in these circumstances, becau se this would amount to asking them to review 
and criticise their proper work".850 
418. Because the parties' positions with respect to the experts "differed significantly", the Panel 
sought additional names of experts from the parties pursuant to paragraph 6 of the Experts Working 
Procedures.851  Of the 71 experts suggested by th e international organizations and the 
parties, 40 experts indicated that they were av ailable, and 35 responded to the request for their 
curriculum vitae  and information regarding pot ential conflicts of interest.852  This information was 
provided to the parties for comments and objections.853  As the Panel explained:   
One party or another submitted objecti ons with regard to all but one 
of the experts by arguing either that an expert lacked sufficient 
expertise in the areas of the dispute identified as needing scientific or technical expertise, or was affiliate d with the government of a party 
to this dispute;  or was affiliated with JECFA;  or had received 
                                                     
 
846Panel Report, US – Continued Suspension , para. 7.78;  Panel Report, Canada – Continued 
Suspension , para. 7.76. (footnotes omitted) 
847Panel Report, US – Continued Suspension , para. 7.79;  Panel Report, Canada – Continued 
Suspension , para. 7.77. 
848Panel Report, US – Continued Suspension , para. 7.79;  Panel Report, Canada – Continued 
Suspension , para. 7.77. 
849Letter from the European Communities to the Panel dated 16 January 2006 (quoted in European 
Communities' appellant's submission, para. 193). 
850Ibid. 
851Panel Report, US – Continued Suspension , para. 7.80;  Panel Report, Canada – Continued 
Suspension , para. 7.78. 
852Panel Report, US – Continued Suspension , para. 7.82;  Panel Report, Canada – Continued 
Suspension , para. 7.80. 
853Panel Report, US – Continued Suspension , para. 7.83;  Panel Report, Canada – Continued 
Suspension , para. 7.81. WT/DS321/AB/R 
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funding from the pharmaceutical industry;  or had been involved in the regulatory approval of any of the six hormones.
854 
419. On 24 March 2006, the Panel informed the pa rties of the six experts it had selected.  The 
Panel explained its considerations in the selection process as follows: 
The Panel excluded experts with close links with governmental 
authorities directly involved in policy-making regarding the six hormones and experts with close links to pharmaceutical companies or involved in public advocacy activities.  The Panel chose not to exclude  a priori  experts who had participated in the preparation and 
drafting of JECFA's risk assessments  because this would deprive the 
Panel and the parties of the benefit of the contribution of internationally recognized specialis ts and because the Panel was of 
the opinion that experts familiar with the JECFA reports would be well-placed to assist the Panel in understanding the work of JECFA 
extensively referred to by the parties in their submissions, in 
particular by the European Communities.  Moreover,  the Panel, who 
was fully aware of the fields of competence of these experts, considered that they  would be competent to answer questions with 
respect to risk assessment regarding the hormones at issue.  The Panel also decided not to exclude  a priori  all experts who were 
current or past governmental employees unless a potential conflict of 
interests could reasonably be assumed from their official functions.  In selecting the experts, the Panel also had in mind the need to choose experts with expertise to cover all the fields identified as at issue in the dispute.
855 
420. The European Communities asked the Panel to r econsider its decision with respect to two 
experts, Dr. Jacques Boisseau856 and Dr. Alan Boobis857, arguing that "these experts had real or 
perceived conflicts of interests that shoul d disqualify them from assisting the Panel."858  In addition to 
reiterating concerns about the involvement of the tw o selected experts "in the drafting and adoption of 
the JECFA reports concerning the subject matter of this dispute"859, the European Communities 
advanced other reasons to exclude Drs. Boisseau  and Boobis.  The European Communities argued 
that Dr. Boisseau should be dismissed because he had not "submitted a statement of conflict of 
interest to the Panel", had "already taken a position on the issue at stake in this dispute" in a public 
                                                      
854Panel Report, US – Continued Suspension , para. 7.84;  Panel Report, Canada – Continued 
Suspension , para. 7.82. 
855Panel Report, US – Continued Suspension , para. 7.85;  Panel Report, Canada – Continued 
Suspension , para. 7.83. (footnote omitted) 
856Former Director, French Agency for Veteri nary Medical Products. (See Panel Report, US – 
Continued Suspension , para. 7.86;  and Panel Report, Canada – Continued Suspension , para. 7.84) 
857Director, Experimental Medicine and Toxicology Division of Medicine, Faculty of Medicine, 
Imperial College, London;  Professor of Biochemical Pharmacology at Imperial College, London.  (See Panel 
Report, US – Continued Suspension , para. 7.86;  and Panel Report, Canada – Continued Suspension , para. 7.84) 
858Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85. 
859Letter from the European Communities to the Panel dated 28 March 2006 (quoted in European 
Communities' appellant's submission, para. 196).  WT/DS321/AB/R 
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hearing before the French Senate, had taken a positi on in a public debate "that only 'major' risks are 
relevant in precautionary decision making", and had neither "carried out any real scientific research" 
nor "written anything on the substances under consideration".860  With regard to Dr. Boobis, the 
European Communities alleged that he had receive d funding from, and provided consultancy to, 
several pharmaceutical companies, some of which had not been disclosed in his statement on conflicts 
of interest.861  The Panel did not consider that th e European Communities' objections were 
"justified"862, adding: 
The Panel found in particular that the statement that one expert had 
made before the French Senate in  1996 had not been made in relation 
to hormones used for growth promotion purposes. Rather, it had been 
made with respect to hormones used  for medical treatment purposes.  
The Panel also found that the links  of another expert with two 
companies involved in research and counselling were not in the area of veterinary drugs or hormonal substances. … In addition, having 
considered the information availa ble about the various candidates, 
the Panel found that  these two experts were the best choices among 
the very few individuals available with expertise in the area of risk assessment and would be able to provide the Panel with insight on international standards on the hormones at issue.
863  
421. At the interim review stage, and upon a re quest made by the European Communities for 
clarification of certain passages, the Panel said th at it "remain[ed] however puzzled by the [European 
Communities'] suggestions that a scientist who worked  with JECFA could be deemed to be biased in 
assessing the scientific evidence on which [European  Communities'] Directive 2003/74/EC relies and 
could be assumed to defend JECFA's work".864  The Panel explained: 
First, scientists would readily admit that science is constantly 
evolving and the fact that new studies are peer reviewed is evidence 
that assessing new ideas and findings is part of scientific work. 
Assuming that scientists may lack objectivity because they 
                                                      
860Letter from the European Communities to the Panel dated 28 March 2006 (quoted in European 
Communities' appellant's submission, para. 196). 
861Ibid. 
862Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85. 
863Ibid.  The Panel further commented that: 
The Panel wishes to highlight the challenges it encountered in selecting 
experts.  There was a limited number of specialists suggested and actually 
available in each of the fields on which the Panel needed assistance and 
almost always one or more of the par ties objected to that specialist.  For 
example, only six of the identified ava ilable experts were deemed to have 
extensive expertise in risk analysis.  A ll of these experts were objected to by 
at least one party. 
(Panel Report, US – Continued Suspension , footnote 382 to para. 7.87;  Panel Report, Canada – Continued 
Suspension , footnote 374 to para. 7.85) 
864Panel Report, US – Continued Suspension , para. 6.22;  Panel Report, Canada – Continued 
Suspension , para. 6.21. WT/DS321/AB/R 
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participated in the preparation and drafting of JECFA's risk assessments on the hormones at issue would call into question the whole principle of peer review.  The Panel also notes that JECFA is the body that provides the independent scientific advice on which the work of Codex is based and Codex is expressly recognized by the 
SPS Agreement  as having responsibilities for the establishment of 
"international standards, guidelines and recommendations".  The Panel also recalls the role given to  international standards, guidelines 
and recommendations by Article 3.1 and 3.2 of the  SPS Agreement .  
It is therefore consistent with this role for the Panel to rely on experts 
who contributed in the preparation and drafting of JECFA's risk 
assessments of the substances at issue.
865 
422. The Panel elaborated further that: 
... it was necessary for the Panel to be able to rely on the advice of 
experts intimately knowledgeable about the substance of JECFA's 
risk assessments. ... Second, the Pa nel recalls that JECFA is an 
international, independent entit y composed of highly qualified 
experts selected by the WHO or FAO according to strict procedures.  
JECFA also regularly reassesses its  risk assessments. ... Moreover, 
JECFA reaches its conclusions by consensus.  So the opinions expressed by the two experts were given with regard to the consensual view of JECFA on this matter, not just their own personal positions in the past.  This does not mean, however, that JECFA's 
work is these particular experts' own work:  it is a joint work by 
several experts. 
The experts that the European Co mmunities claims were defending 
their work acknowledge that the st ate of knowledge can evolve. ... 
The experts consulted by the Panel are used to considering and peer 
reviewing studies that go beyond what they have published 
themselves or perhaps even contradict them.  In other words, they are 
not likely to feel any need to defe nd their own previous work results 
in the light of new, convincing evidence or techniques that put such previous work into doubt.
866   
423. The Panel also rejected the European Communitie s' argument that "the two experts at issue 
should not be described as 'internationally recognized specialists'"867: 
The Panel recalls that they have been selected by the FAO and WHO 
as part of the JECFA selection process.  The selection procedure has been described in JECFA's reply to question 14 to JECFA.  The 
Panel fails to understand why the JECFA selection would not be 
evidence of the international reputati on of the scientists at issue.  The 
[European Communities] concerns about JECFA's work and the 
                                                     
 
865Panel Report, US – Continued Suspension , para. 6.22;  Panel Report, Canada – Continued 
Suspension , para. 6.21. 
866Panel Report, US – Continued Suspension , paras. 6.62 and 6.63;  Panel Report, Canada – Continued 
Suspension , paras. 6.57 and 6.58. (footnotes omitted) 
867Panel Report, US – Continued Suspension , para. 6.23;  Panel Report, Canada – Continued 
Suspension , para. 6.22.  WT/DS321/AB/R 
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selection of experts to participate in that work are in contradiction with the role attributed by the SPS Agreement  to Codex and to 
international standards, guidelin es and recommendations.  The Panel 
was fully aware of the area of expertise of the two scientists at issue, and believed that they would be more at liberty to comment on the 
content of JECFA's work than offici als of the JECFA Secretariat.  It 
also specified the reasons why those experts were selected in spite of 
not having carried out experiments with the substances at issue and does not see any need for further substantial elaboration.
868 
424. During the Panel proceedings, the experts provided written responses to scientific and 
technical questions posed by the Panel.869  The Panel held a meeting with the scientific experts, which 
included the participation of the parties.  At the m eeting, the parties and the Panel had the opportunity 
"to ask questions to the experts and for the experts to  clarify points that they had made in their written 
responses to the questions".870 
B. Claims and Arguments on Appeal  
425. On appeal, the European Communities asserts that  "the consultation of experts by the Panel[] 
for the purposes of scientific and technical advice including their selection must respect general principles of law, and in particular the principle of due process."
871  The European Communities adds 
that "[i]t is inherent in the principle of due process that the parties to a dispute are given a fair hearing 
including that the experts a court, tribunal or panel hears or consults are  independent and 
impartial ."872  The European Communities takes issue with the Panel's selection of Dr. Jacques 
Boisseau and Dr. Alan Boobis.  The European Comm unities claims that "any 'reliance' the Panel[] 
[has] placed on what these two experts from JECFA said  is a violation of the relevant rules on conflict 
of interest, of its rights of due process and of the requirement for the Panel[] to perform an 'objective 
assessment' of the matter before [it]"873 as required under Article 11 of the DSU.  As a result, the 
European Communities requests that the Appellate Body "reverse all findings of the Panel[] which 
depend on the advice [it] received from these experts".874 
426. The European Communities contends that "the relevant legal test" the Panel should have 
applied is whether there was "likelihood or justifia ble doubts" as to the experts' independence, a test 
                                                      
868Panel Report, US – Continued Suspension , para. 6.23;  Panel Report, Canada – Continued 
Suspension , para. 6.22. (footnotes omitted) 
869Panel Report, US – Continued Suspension , paras. 7.95-7.97;  Panel Report, Canada – Continued 
Suspension , paras. 7.92-7.94. 
870Panel Report, US – Continued Suspension , para. 7.98;  Panel Report, Canada – Continued 
Suspension , para. 7.95. (footnote omitted)  The Panel's meeting with the scientific experts took place 
immediately before the second substantive meeting of the Panel with the parties. 
871European Communities' appellant's submission, para. 188. 
872Ibid. (original emphasis) 
873Ibid., para. 202. 
874Ibid., para. 212. WT/DS321/AB/R 
Page 178  
 
that the European Communities descr ibes as "quite simple and low", and not requiring "certainty or 
high probability".
875  The standard applied by the Panel, however, was "based on a very narrow 
definition of a perceived conflict of interest becaus e it required an actual or almost certain conflict, 
not a perceived, likelihood or a justifiable doubts test".876  The European Communities asserts that 
Dr. Boisseau took "a position in favour of the saf ety of these hormones" and that "Dr. Boobis has 
been receiving funding from the pharmaceutical  industry in his research and counselling".877  I n  
addition, the European Communiti es alleges that, since Drs. Boisseau and Boobis were among the 
authors of the JECFA reports, which are criticized  in Directive 2003/74/EC on scientific grounds, 
they should have been precluded from providing expert advice to the Panel.  The European 
Communities observes that, as co-authors of the JECF A reports, "[t]hey cannot be considered to be 
independent and impartial in these circumstances,  because this would amount to asking them to 
review and criticise reports that are their own doing."878   
427. The European Communities also faults the Panel for "relying overwhelmingly"879 on the 
opinions of Drs. Boisseau and Boobis;  for failing to  ensure that the self-disclosure requirement under 
the Rules of Conduct  be complied with before selecting these experts880;  for failing to "actually 
examine[] whether all of the experts had a potential conflict of interest";  and for accepting as experts 
persons whose independence a nd impartiality was not assured.881  Finally, the European Communities 
argues that, "even if one were to take the view that the Panel[] could accept the non-independent 
experts provided that [it] would constantly bear  in mind the potential conflicts when weighing the 
expert opinions, it is clear that the Panel[] refused to do so, considering the issue of the experts finally 
resolved when dismissing the European Communities' objections."882  Indeed, these experts 
"dominate[d] the entire scientific examination by th e Panel[] both from the point  of view of how often 
they [were] referred to and whether the Panel[] ever question[ed] their opinions and whether their 
opinions go beyond science and stray into the area of the risk regulator."883 
428. The United States argues that the Panel's conduct in the selection of experts was transparent 
and consultative, providing the parties with notice and opportunities to respond, express their
                                                      
875European Communities' appellant's submission, para. 195. 
876Ibid., para. 203. 
877Ibid.  The European Communities qualifies its charges against both experts.  It admits, for instance, 
that Dr. Boisseau's position on the safety of hormones was taken "in the context of a discussion on therapeutic 
treatment in animals", and that the funding Dr. Boobis received from the pha rmaceutical industry was "not from 
companies in the area of veterina ry drugs or these hormones".  ( Ibid.) 
878Ibid., para. 205. 
879Ibid., para. 212. 
880Ibid., para. 192. 
881Ibid. 
882Ibid., para. 211. (footnote omitted) 
883Ibid., para. 208.  WT/DS321/AB/R 
 Page 179 
 
 
concerns, and be heard before the Panel made its decisions.  The United States further asserts that 
"[t]he fact of the matter is that the Panel and th e parties were provided with full disclosure of the 
experts' professional affiliations and financial interests" and "[t]he record demonstrates that the Panel 
took the [European Communities'] concerns into account in concluding that the two experts in 
question were not disqualified from serving."884  Moreover, the United States alleges that the 
European Communities provides no support for the cl aims regarding due process rights, arguing that 
the European Communities cited nothing more "than the most general statement" by the Appellate 
Body in Thailand – H-Beams  and a judgment by the European Court of Human Rights that the 
European Communities had already relied upon in its challenge to the panel's expert selection process 
in EC – Hormones .885  Finally, in respect of the European  Communities' allegation of breach of 
Article 11 of the DSU, the United States argues that the Panel acted within the proper bounds of its 
discretion as fact-finder.886 
429. Canada rejects the position of the European Comm unities that the relevant legal standard to 
determine independence or impartiality  is "likelihood or justifiable doubt".887  Rather, it observes that 
the only standard governing conflict of interest ques tions is found in Section II (Governing Principle) 
of the Rules of Conduct .  That provision requires that all persons covered under the Rules of Conduct , 
including experts, "shall be independe nt and impartial" and "shall avoid direct or indirect conflicts of 
interest".888  Moreover, Canada asserts that Drs. Bois seau and Boobis met the disclosure requirement 
in the Experts Working Procedures, and that, in particular, both complied with the requirements by 
disclosing their involvement in JECFA.  In Canada's  view, "it was up to the Panel to evaluate whether 
this had an impact [on] the independence and impartiality of these candidates in this case."889 
430. Canada argues that the Panel correctly found th at Drs. Boisseau and Boobis were independent 
and impartial.  It notes that the Panel "expressly addressed" the allegation that these two experts were 
defending their work when it explained that the pu rpose of consulting them was to obtain advice 
about the substance of JECFA's risk assessment, and to help identify the extent to which concerns 
raised by the European Communities had been  considered in JECFA's risk assessment.890  Canada 
also points to language in the Panel Report, not ing that the Panel was asking the experts about 
JECFA's consensual view, which may differ from the experts' personal views, and that both experts 
                                                      
884United States' appellee's submission, para. 88. 
885Ibid., para. 89. 
886Ibid., para. 90. 
887Canada's appellee's submission, para. 47 (quotin g European Communities' appellant's submission, 
para. 195). 
888Ibid., para. 47. 
889Ibid., para. 49. 
890Ibid., para. 54 (quoting Panel Report, Canada – Continued Suspension , para. 6.57). WT/DS321/AB/R 
Page 180  
 
admitted to the Panel that the state of scientific knowledge can evolve.
891  In Canada's view, it is 
inaccurate to portray the participation by Drs. Bo isseau and Boobis in JECFA panels as "giving them 
an (almost proprietary) interest in the outcome of the JECFA process that they would have felt 
compelled to defend when advising the Panel".892  Canada cautions that the practical consequence of 
the Panel excluding Drs. Boisseau and Boobis as expert s would have been that "the pool of eligible 
experts would have been shrunk significantly, such that it would have become very difficult for the 
Panel to appoint experts in all the areas of expertise that it had identified."893 
431. Therefore, the United States and Canada request that the Appellate Body reject the European 
Communities' claim that the Panel acted inconsis tently with the principle of due process, the 
requirements of the  Rules of Conduct , and Article 11 of the DSU, in selecting Drs. Boisseau and 
Boobis, and to reject the request to reverse the Panel's findings that relied on the advice of these two 
experts. 
432. Australia agrees with the European Communities'  submission that panels must observe due 
process in selecting and consulting with experts, and considers that fundamental fairness and due 
process "permeate[] all aspects of the WTO disput e settlement process, including a panel's use of 
experts".894   
C. Did the Panel Infringe the European Co mmunities' Due Process Rights and Fail to 
Make an Objective Assessment of the Matter in the Consultations with the Scientific 
Experts 
433. The Appellate Body has previously found that  the obligation to a fford due process is 
"inherent in the WTO dispute settlement system"895 and it has described due process requirements as 
"fundamental to ensuring a fair and orderl y conduct of dispute settlement proceedings".896  In our 
view, the protection of due process is an essential f eature of a rules-based system of adjudication, 
such as that established under the DSU.  Due pro cess protection guarantees that the proceedings are 
conducted with fairness and impartiality, and that one party is not unfairly disadvantaged with respect 
to other parties in a dispute. 
434. The Appellate Body has recognized the need for panels to afford due process to the parties 
with respect to specific procedural issues.  Fo r instance, the Appellate Body has recognized due 
                                                      
891Canada's appellee's submission, para. 54 (quoting Panel Report, Canada – Continued Suspension , 
para. 6.57). 
892Ibid., para. 56. 
893Ibid., para. 57. 
894Australia's third participant's submission, para. 48. 
895Appellate Body Report, Chile – Price Band System , para. 176.  See also Appellate Body Report, 
Mexico – Corn Syrup (Article 21.5 – US) , para. 107. 
896Appellate Body Report, Thailand – H-Beams , para. 88.   WT/DS321/AB/R 
 Page 181 
 
 
process as requiring that parties to proceedings be afforded an adequate opportunity to respond to 
claims, arguments, or evidence presented by other parties.897  It has also referred to the principle of 
due process in suggesting the need for pane ls to have standard working procedures898, and for panels 
to have discretion to allow for the en hanced participation by third parties.899  Moreover, the Appellate 
Body has found that due process is required by Article 11 of the DSU.  In US – Gambling , the 
Appellate Body stated: 
[A]s part of their duties, under Article 11 of the DSU, to "make an 
objective assessment of the matter" before them, panels must ensure 
that the due process rights of parties to a dispute are respected.900 
435. These due process considerations are reflected in the Rules of Conduct .  Section II (Governing 
Principle) of the Rules of Conduct  provides that all covered persons , such as panelists and experts 
advising panels: 
... shall  be independent and impartia l, shall avoid direct or indirect 
conflicts of interest and shall respect the confidentiality of 
proceedings of bodies pursuant to th e dispute settlement mechanism, 
so that through the observance of  such standards of conduct the 
integrity and impartiality of that mechanism are preserved.  
436. Scientific experts and the manner in which thei r opinions are solicited and evaluated can have 
a significant bearing on a panel's consideration of th e evidence and its review of a domestic measure, 
especially in cases like this one in volving highly complex scientific issues.  Fairness and impartiality 
in the decision-making process are fundamental gua rantees of due process.  Those guarantees would 
not be respected where the decision-makers appoint  and consult experts who are not independent or 
impartial.  Such appointments and consultations compromise a panel's ability to act as an independent 
adjudicator.  For these reasons, we agree with the view of the European Communities that the 
protection of due process applies to a panel's consu ltations with experts.  This due process protection 
applies to the process for selecting experts and to the panel's consultations with the experts, and 
continues throughout the proceedings. 
                                                      
897Appellate Body Report, US – Gambling , paras. 269-273;  Appellate Body Report, Canada – Wheat 
Exports and Grain Imports , para. 177;  Appellate Body Report, Mexico – Corn Syrup (Article 21.5 – US) , 
para. 47;  Appellate Body Report, Australia – Salmon , paras. 272 and 278;  and Appellate Body Report, Brazil – 
Desiccated Coconut , p. 22, DSR 1997:I, 167, at 186. 
898Appellate Body Report, Argentina – Textiles and Apparel , footnote 68 to para. 79;  Appellate Body 
Report, India – Patents (US) , para. 95. 
899Appellate Body Report, US – FSC (Article 21.5 – EC) , para. 243;  Appellate Body Report, EC – 
Hormones , para. 154. 
900Appellate Body Report, US – Gambling , para. 273. WT/DS321/AB/R 
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(a) Standard for Selection of Experts 
437. The authority to seek information from individuals or to consult experts is provided to panels 
pursuant to Article 13 of the DSU (Right to Seek Information).  Article 13.2 provides: 
Panels may seek information fro m any relevant source and may 
consult experts to obtain their opinion on certain aspects of the 
matter.  With respect to a factual issue concerning a scientific or other technical matter raised by a party to a dispute, a panel may 
request an advisory report in writing from an expert review group.  Rules for the establishment of such  a group and its procedures are set 
forth in Appendix 4. 
438. Article 11.2 of the SPS Agreement  specifically addresses the consultation of experts in 
disputes under that Agreement.
901  It reads:  
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 th e dispute.  To this end, the panel 
may, when it deems it appropriate, establish an advisory technical experts group, or consult the releva nt international organizations, at 
the request of either party to the dispute or on its own initiative. 
439. Panels are understood to have "significant investigative authority"
902 under Article 13 of the 
DSU and Article 11.2 of the  SPS Agreement  and broad discretion in exercising this authority.  In 
US – Shrimp , the Appellate Body expounded on the co mprehensive authority of panels under 
Article 13: 
The comprehensive nature of the authority of a panel to "seek" 
information and technical advice from "any individual or body" it may consider appropriate, or from "any relevant source", should be 
underscored.  This authority embrac es more than merely the choice 
and evaluation of the source  of the information or advice which it 
may seek.  A panel's authority in cludes the authority to decide not to 
seek such information or advice at all.  We consider that a panel also 
has the authority to accept or reject  any information or advice which 
it may have sought and received, or to  make some other appropriate 
disposition  thereof.  It is particularly within the province and the 
authority of a panel to determine the need for information and  advice  
in a specific case, to ascertain the acceptability  and relevancy  of 
information or advice received, and to decide what weight to ascribe 
                                                     
 
901Article 11.2 of the  SPS Agreement  is listed in Appendix 2 of the DSU (Special or Additional Rules 
and Procedures contained in the covered agreements). 
902Appellate Body Report, Japan – Agricultural Products II , para. 129.    WT/DS321/AB/R 
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to that information or advice  or to conclude that no weight at all 
should be given to what has been received.903  
440. The European Communities has not challenged on  appeal the Panel's decision to consult 
experts  per se , nor does it claim that the Panel failed to consult with the parties on expert selection.904  
The European Communities disagrees with the Panel's decision to consult experts individually, rather 
than establish an expert review group, but does not raise a claim in this respect on appeal.905 
441. Paragraph 9 of the Experts Working Procedures adopted by the Panel prescribes that experts 
will be selected "on the basis of their qualification and the need for specialized scientific or technical 
expertise".  Paragraph 11 additionally provides: 
The selected experts shall act in their individual capacities and not as 
representatives of any entity.  They shall be subject to the Rules of 
Conduct for the Understanding on Rules and Procedures Governing 
the Settlement of Disputes  (WT/DSB/RC1), including the self-
disclosure requirement set out in Section VI of the Rules of Conduct .  
442. As we noted earlier, experts advising panels are specifically covered by the Rules of Conduct  
and, pursuant to Section II (Governing Principle), they "shall be independent  and impartial, [and] 
shall avoid direct or indirect conflicts of interest ... , so that through the observance of such standards 
of conduct the integrity and impartiality of that mechanism are preserved".  
443. Selected experts are also subject to certain self-disclosure and confid entiality obligations set 
out elsewhere in the  Rules of Conduct , and procedures exist for the refe rral of a "material violation" 
of these obligations to the Chairman of the DSB for appropriate action.906 
444. The European Communities claims that due pro cess requires that the "experts a court, tribunal
                                                      
903Appellate Body Report, US – Shrimp , para. 104. (original emphasis)  Given the manner in which the 
Appellate Body has addressed the scope of a panel's au thority under Article 13 of the DSU, this discretion 
would seem to apply equally to the discretion of panels under Article 11.2 of the  SPS Agreement . 
904The Appellate Body has found that panels are free to consult experts as individuals or as part of an 
expert review group.  (Appellate Body Report, EC – Hormones , para. 147)  
905The European Communities notes that the Panel "for no good reason declined to follow the 
European Communities' suggestion to constitute an expert  review group", and that "[i]n retrospect, this has 
proven disastrous in this case in view of the very different, conflicting and irreconcilable opinions it received on 
many crucial issues from its experts." (European Communitie s' appellant's submission, footnote 76 to para. 187)  
The Panel explained its decision to consult experts on an individual basis with the following reasons:  (1) the 
experts' varying fields of competence would make it important, on relevant subjects, to consult experts individually on their respective field of expertise;  and (2) it did not want a consensus text from an expert review 
group that would reflect a minimum common position, but wished to hear dissenting or minority views among 
the experts. (Panel Report, US – Continued Suspension , para. 7.71;  Panel Report, Canada – Continued 
Suspension , para. 7.69) 
906Rules of Conduct , Sections VI (Self-Disclosure Requirements by Covered Persons), 
VII (Confidentiality), and VIII (Procedures Concerning Possible Material Violations). WT/DS321/AB/R 
Page 184  
 
or panel hears or consults are  independent and impartial ."
907  It then asserts that the relevant legal test 
for evaluating whether an expert is independent  and impartial is founded on the self-disclosure 
obligation in Section VI.2 of the Rules of Conduct , which requires that experts "disclose any 
information ... which is likely to affect or give rise to justifiable doubts as to their independence or impartiality".  This is a standard the European Communities asserts is "simpl e and low" and "does not 
require certainty or high probability".
908 
445. The requirements under Section VI of the Rules of Conduct  relate, as the title indicates, to the 
self-disclosure obligation of covered persons, including experts.  The Rules of Conduct  do not provide 
for automatic exclusion of a cove red person upon the disclosure of info rmation pursuant to Section VI 
and the Illustrative List of Information to  be Disclosed, which is attached to the Rules of Conduct  as 
Annex 2.  However, we fail to see on what basis a pa nel, presented with information likely to affect or 
give rise to justifiable doubts as to the independen ce or impartiality of an expert, could choose to 
consult such an expert.  
446. We do not agree, however, with the European Communities' characterization of Section VI.2 
as setting out a "low" standard.  On the contrary, we c onsider the standard set forth in Section VI.2 to 
be a strict one.  Covered persons should be enc ouraged to disclose any information that may be 
relevant for purposes of ascertaining whether ther e may be justifiable doubts as to their independence 
or impartiality.  Disclosure should not lead to  automatic exclusion.  Whether the disclosed 
information is likely to affect or give rise to justifiable doubts as to the person's independence or 
impartiality must be objectively dete rmined and properly subs tantiated.  In the case of an expert, the 
panel should assess the disclosed information agains t information submitted by the parties or other 
information that may be available.  It should then determine whether, on the correct facts, there is a 
likelihood that the expert's inde pendence and impartiality may be a ffected, or if justifiable doubts 
arise as to the expert's independe nt or impartiality.  If this is indeed the case, the panel must not 
appoint such person as an expert.   
(b) Disclosure of Conflicts of Interest 
447. The European Communities also argues that th e Panel did not enforce compliance with the 
self-disclosure requirement, and did not adequately explore potential conflicts of interest.  The 
European Communities charges that the Panel "faile d to require that the self-disclosure requirement 
                                                      
907European Communities' appellant's submission, para. 188. (original emphasis) 
908Ibid., para. 195.  WT/DS321/AB/R 
 Page 185 
 
 
be complied with"909 for Dr. Boisseau and therefore rendered paragraph 4 of the Experts Working 
Procedures "a dead letter".910   
448. Section VI.2 of the Rules of Conduct  requires all covered pers ons, including experts, to 
"disclose any information that could reasonably be e xpected to be known to them at the time which, 
coming within the scope of the Governing Principle of these Rules, is likely to affect or give rise to 
justifiable doubts as to their independence or impartia lity".  The Illustrative List of Information to be 
Disclosed pursuant to Section VI includes the fo llowing examples of matters to be disclosed: 
(b) professional interests (e.g. a past or present relationship with 
private clients, or any interests the person may have in domestic or 
international proceedings, and their implications, where these involve 
issues similar to those addressed in the dispute in question); 
(c) other active interests (e.g. activ e participation in public interest 
groups or other organizations whic h may have a declared agenda 
relevant to the dispute in question); 
(d) considered statements of pers onal opinion on issues relevant to 
the dispute in question (e.g. publications, public statements). 
449. Paragraph 4 of the Experts Working Procedures adopted by the Panel provides: 
The Panel will seek a  curriculum vitae , including all relevant 
publications, from each individual suggested.  The candidate experts will also be asked to provide inform ation about potential conflicts of 
interest and indications on whether they have worked for, been funded by or provided advice to the industries concerned, or to 
domestic or international regulator y bodies involved in issues similar 
to those addressed in this dispute.  A list of eligible experts, including 
their  curricula vitae  and declarations of interest will be provided to 
the parties.  Parties will have sufficient time to examine them and will be given the opportunity to comment on and to make known any 
compelling objections to any particular expert.
911 
450. In his self-disclosure statement, Dr. Boisseau stat ed that "[h]aving worked as a civil servant, I 
have no conflict of interest which could prevent me  to serve as a scientific expert to these two WTO 
panels."912  The purpose of the self-disclosure statement is  to reveal relevant facts that would allow 
the Panel to determine whether the information is likel y to affect or give rise to justifiable doubts as to 
the expert's independence or impartiality.  Instead , Dr. Boisseau's statement draws a conclusion on a 
matter that was for the Panel to decide.  Dr. Bois seau's statement does not identify whether he has 
"worked for, been funded by, or provided advice to , the industries concerned, or to domestic or 
                                                      
909European Communities' appellant's submission, para. 192. 
910Ibid., para. 197.  
911Panel Reports, Annex A-5, p. A-10. 
912See Panel record document, "Information on Conflict of Interest by Dr. Jacques Boisseau" (undated).  WT/DS321/AB/R 
Page 186  
 
international regulatory bodies involved in issues sim ilar to those addressed in this dispute".  The 
statement does not mention his affiliation with JECFA, nor the fact that he was the Chairman or Vice-
Chairman of JECFA panels that evaluated some of the hormones at issue in this dispute.
913  A l s o ,  
Dr. Boisseau's position as a civil servant did not itself shield him from having a conflict of interest.  Thus, we agree with the European Communities that  Dr. Boisseau's statement would not appear to 
comply fully with the requirements of Section VI.2 of the Rules of Conduct  or paragraph 4 of the 
Experts Working Procedures adopted by the Panel. 
451. We note that, in Canada's view, the self-dis closure requirement was satisfied by the 
information provided on Dr. Boisseau's  curriculum vitae , which it considers provided full disclosure 
of Dr. Boisseau's involvement with JECFA.
914  While panels should insist that self-disclosure 
requirements under the Rules of Conduct  are observed by potential experts, and while parties are 
entitled to full self-disclosure by experts, we find that the Panel did not exceed its authority in 
concluding that Dr. Boisseau's brief statement, wh en considered together with the information 
contained in his  curriculum vitae , provided sufficient disclosure in this case.  Dr. Boisseau's 
curriculum vitae  provides information about his involvem ent with JECFA and his other professional 
activities.915 
452. The European Communities also claims that th e Panel "never actually examined whether all 
of the experts had a potential conflict of interest a nd whether the experts fulfilled the conditions to be 
truly independent and impartial".916  We understand this claim to refer to the objections of the 
European Communities, also raised in its lette r to the Panel dated 28 March 2006, that:  
(i) Dr. Boisseau stated "in a public hearing in th e French Senate, in 1996 ... that the three natural 
hormones do not present a danger for public health";  (ii) Dr. Boisseau took the position "in a public debate ... that only 'major' risks are relevant in precautionary decision making";  and (iii) Dr. Boobis 
allegedly received funding from one pharmaceutical company at the time of his disclosure, and did 
not disclose potential funding and affiliations with two others.
917   
                                                      
913See infra , para. 458. 
914Canada's appellee's submission, para. 49.  
915Dr. Boisseau's curriculum vitae  indicates that he was a member  of JECFA between 1988-2001, its 
Chairman in 1994, 1998, 2000, and 2002, and its Vice-Chairman in 1992, 1994, 1995, 1997, and 2001. 
916European Communities' appellant's submission, para. 192. 
917Letter from the European Communities to the Panel dated 28 March 2006 (quoted in European 
Communities' appellant's submission, para. 196).  WT/DS321/AB/R 
 Page 187 
 
 
453. The Panel stated that it had "carefully c onsidered the European Communities' request, 
including the information given regard ing potential conflicts of interest".918  Nonetheless, the Panel 
found that the European Communities'  objections "were not justified"919, adding: 
The Panel found in particular that the statement that one expert had 
made before the French Senate in  1996 had not been made in relation 
to hormones used for growth promotion purposes. Rather, it had been 
made with respect to hormones used  for medical treatment purposes.  
The Panel also found that the links  of another expert with two 
companies involved in research and counselling were not in the area of veterinary drugs or hormonal substances.
920 
454. The European Communities challenge s the "narrow" conflict of in terest definition applied by 
the Panel, and reiterates the "undisputed facts" that: 
... Dr. Boisseau did take a position in favour of the safety of these 
hormones, albeit in the context of a discussion on therapeutic treatment in animals, and that Dr. Boobis has been receiving funding from the pharmaceutical industry in  his research and counselling, 
albeit not from companies in the area of veterinary drugs or these 
hormones (although this has never be en specifically verified). ... As 
regards the industry funding of Dr. Boobis, the Panels refrained from 
verifying whether there were any actual or possible links of the companies funding him with other companies producing veterinary 
drugs or these hormones.  In fact, as far as the European 
Communities knows, the Panels re frained from asking any question 
to Dr. Boobis on this precise issue.
921 
As we have found, the standard to be applied by pa nels when selecting experts is whether there is an 
objective basis to conclude that an expert's indepe ndence or impartiality is likely to be affected or 
there are justifiable doubts about that  expert's independence or impartia lity.  In this instance, the Panel 
explained that it "carefully considered" the objec tions, "including the information given regarding 
                                                      
918Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85. 
919Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85. 
920Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85.  The Panel further commented that: 
The Panel wishes to highlight the challenges it encountered in selecting 
experts.  There was a limited number of specialists suggested and actually 
available in each of the fields on which the Panel needed assistance and 
almost always one or more of the par ties objected to that specialist.  For 
example, only six of the identified ava ilable experts were deemed to have 
extensive expertise in risk analysis.  A ll of these experts were objected to by 
at least one party. 
(Panel Report, US – Continued Suspension , footnote 382 to para. 7.87;  Panel Report, Canada – Continued 
Suspension , footnote 374 to para. 7.85) 
921European Communities' appellant's submission, para. 203. WT/DS321/AB/R 
Page 188  
 
potential conflicts of interest", before concluding that the objections were "not justified".
922  
Moreover, the Panel provided specific explanations as to why it disagreed with the objections of the 
European Communities.923   
455. On appeal, the European Communities recognizes th at Dr. Boisseau's statement in the French 
Senate did not refer to the use of the hormon es for growth-promotion purposes.  The European 
Communities does not provide argumentation explaini ng why Dr. Boisseau's statement concerning the 
use of the hormones for therapeutic purposes signifies that he would not be impartial in his views 
concerning the use of these hormones for growth -promotion purposes.  The European Communities 
itself regulates the use of the hormones at issue for veterinary purposes differently from the use for 
growth-promotion purposes in Directive 2003/74/EC.924  In addition, we do not consider that in this 
case the information about Dr. Boobis' links to certain pharmaceutical companies provided an 
objective basis to conclude that there were justif iable doubts as to his impartiality or independence.  
The European Communities did not present evidence  indicating that the companies from which Dr. 
Boobis received funding had links with other comp anies producing veterinary drugs or the hormones 
at issue.  Thus, we consider that the Panel did not exceed its authority in dismissing the European 
Communities' objections relating to disclosure statements given by Drs. Boisseau and Boobis 
pursuant to the Rules of Conduct  and paragraph 4 of the Experts Working Procedures adopted by the 
Panel. 
(c) Previous Affiliation with JECFA 
456. The European Communities claims that the reas ons provided by the Panel for declining to 
exclude Drs. Boisseau and Boobis never addressed the fundamental question of their affiliation with 
JECFA.  In the view of the European Commun ities, the Panel disregarded its "most important 
objection"925 that an expert who has participated in the drafting of JECFA reports cannot be 
independent and impartial because, in this case, the experts were being asked to evaluate new 
scientific evidence underlying reports that were direc tly critical of, or in conflict with, their prior 
contribution to the JECFA reports.  The European  Communities argues that as "authors of the JECFA 
reports"926, Drs. Boisseau and Boobis "cannot be consider ed to be independent and impartial in these 
                                                      
922Panel Report, US – Continued Suspension , para. 7.87;  Panel Report, Canada – Continued 
Suspension , para. 7.85. 
923Ibid. 
924Directive 2003/74/EC states that "the use of cer tain of the [hormones at issue], where this is 
necessary, for therapeutic purposes or zootechnical treatment may continue to be authorised as it is not likely to 
constitute a hazard for public health owing to the nature  and the limited duration of the treatments, the limited 
quantities administered and the strict conditions laid down in Directive 96/22/EC in order to prevent any possible misuse." (Directive 2003/74/EC, Recital 11) 
925European Communities' appellant's submission, para. 203. 
926Ibid., para. 205.  WT/DS321/AB/R 
 Page 189 
 
 
circumstances, because this would amount to asking th em to review and criticise reports that are their 
own doing".927 
457. JECFA, which is administered jointly by the FAO and the WHO, is "an international expert 
scientific committee" that evaluates the safety of food additives, contaminants, naturally-occurring 
toxicants and residues of veterinary drugs in food.928  JECFA "performs risk assessments and provides 
advice to FAO, WHO and the member countries of both organizations".929  Some countries use 
information from JECFA in their national food safety control programmes.930  Requests for scientific 
advice "are in general channelled through the Codex Alimentarius Commission (Codex)".931  Codex 
also adopts international standards b ased on evaluations performed by JECFA.932  Codex has adopted 
international standards for five of the hormones at issue in this case, that is, oestradiol-17 β, 
testosterone, progesterone, trenbolone acetate, and zeranol, on the basis of evaluation performed by 
JECFA.933  In addition, Codex has initiated a standard -setting process for MGA, also on the basis of 
JECFA's evaluation, but this process has not yet concluded.934 
458. The risk assessments performed by JECFA in relation to oestradiol-17 β, testosterone, 
progesterone, trenbolone acetate, and zeranol lie at th e centre of the dispute between the participants 
in this case.  In the case of oestradiol-17 β, the European Communities argued that "the Codex 
approach has serious limitations in non-linear situa tions, such as with regard to these hormones", and 
explained that "currently availa ble Codex guidance poorly addresses ca ses such as this where the risks 
are embedded in changes in exposure to biologi cally active molecules which may, with minute 
differences in their bioavailability,  have dramatic effects, such as turning on or off complete 
developmental programmes of the human geno me, or inducing pathological conditions."935  T h e  
European Communities also argued that JECFA' s evaluation was based on "outdated" data.936  As for 
the four hormones that are subject to the provision al ban and for which there is an international
                                                      
927European Communities' appellant's submission, para. 205. 
928Panel Report, US – Continued Suspension , footnote 377 to para. 7.78;  Panel Report, Canada – 
Continued Suspension , footnote 369 to para. 7.76. 
929Ibid. 
930Ibid. 
931Ibid. 
932Ibid. 
933Codex Alimentarius Commission, Maximum Residue Limits for Veterinary Drugs in Foods , updated 
as at the 29th Session of the Codex Alimentarius Commission (July 2006), CAC/MRL 2 (Exhibit CDA-22 
submitted by Canada to the Panel in Canada – Continued Suspension ). 
934See Panel Report, US – Continued Suspension , para. 7.813;  Panel Report, Canada – Continued 
Suspension , para. 7.799. 
935Panel Report, US – Continued Suspension , para. 7.458;  Panel Report, Canada – Continued 
Suspension , para. 7.446 (referring to reply of the European Communities to Question 24 posed by the Panel, 
Panel Reports, Annex B-1, para. 140). 
936Panel Report, US – Continued Suspension , para. 7.423;  Panel Report, Canada – Continued 
Suspension , para. 7.414. WT/DS321/AB/R 
Page 190  
 
standard, the European Communities asserted that  the conclusions reached by JECFA in 1988 
and 1999 are "no longer valid".
937  As regards MGA, which is also subject to the provisional ban, the 
European Communities notes that "nearly all the studies" referred to in the 2000 JECFA report 
evaluating MGA "date from the 1960s and 1970s".938  The European Communities considered 
JECFA's assessment of these hormones to be "insufficient"939 for purposes of conducting a risk 
assessment of the type required by the  SPS Agreement , in light of the fact that the European 
Communities had decided to adopt a higher level of protection than that underlying JECFA's 
international standards.940  In these circumstances, the Panel should have closely scrutinized any 
institutional links the experts may have had with  JECFA and objectively determined whether those 
links were likely to affect or give rise to ju stifiable doubts as to the experts' independence or 
impartiality.   
459. Both Drs. Boisseau and Boobis had close institu tional links with JECFA.  Dr. Boisseau was a 
member of JECFA from 1987 to 2002.941  Dr. Boobis was a member from 1997 to 2006.  Membership 
of JECFA, in our view, reflects international recogniti on of the expertise of a particular scientist.  The 
Panel observed, in this regard, that JECFA is an "international, independent entity composed of highly 
qualified experts selected by the WHO or FAO according to strict procedures".942  We agree with the 
Panel that Drs. Boisseau and Boobis are highly qualified scientists.  We do not see the fact that Drs. Boisseau and Boobis are qualified and know ledgeable—and thus experts—as giving rise to
                                                     
 
937Panel Report, US – Continued Suspension , para. 4.226;  Panel Report, Canada – Continued 
Suspension , para. 4.217. 
938Panel Report, US – Continued Suspension , para. 4.233;  Panel Report, Canada – Continued 
Suspension , para. 4.221. 
939Panel Report, US – Continued Suspension , para. 4.234;  Panel Report, Canada – Continued 
Suspension , para. 4.222. 
 940By contrast, as we explain in sec tion VII.E, the Panel considered that the existence of international 
standards (or, in the case of MGA, of an advanced proc ess that could eventually l ead to the adoption of an 
international standard) established a presumption that there was sufficient scientific evidence to conduct a risk assessment.  The Panel explained its view as follows: 
The presumption of consistency of m easures conforming to international 
standards, guidelines and recommendations with the relevant provisions of the SPS Agreement  implies that these standards, guidelines or 
recommendations, particularly those referred to in this case, are based on 
risk assessments that meet the requirements of the  SPS Agreement .  This 
means, therefore, that there was suffi cient evidence for JECFA to undertake 
the appropriate risk assessments.  
(Panel Report, US – Continued Suspension , para. 7.644;  Panel Report, Canada – Continued Suspension , 
para. 7.622) (footnote omitted) 
941Dr. Boisseau's curriculum vitae  indicates that he was a member of JECFA from 1988-2001.  
However, he is listed as a member in JECFA's 32nd Report, which corresponds to a session held in Rome 
on 15-23 June 1987, and also in JECFA's 58th Report, which corresponds to a session held in Rome 
on 21-27 February 2002.  (See Exhibit US-25 submitted by the United States to the Panel;  and Exhibits CDA-29 and CDA-34 submitted by Canada to the Panel) 
942Panel Report, US – Continued Suspension , para. 6.62;  Panel Report, Canada – Continued 
Suspension , para. 6.57.  WT/DS321/AB/R 
 Page 191 
 
 
concerns about their impartiality and independence.  On the contra ry, we would expect a person who 
is regarded as an expert to hold views, and even ve ry strong views, on his or her particular area of 
expertise.  However, we agree with the European  Communities that the qualifications and relevant 
knowledge of Drs. Boisseau and Boobis are not  by themselves sufficient guarantees of their 
independence and impartiality.943  An expert could be  very qualified and knowledgeable and yet his or 
her appointment could give rise to  concerns about his or her impartiality or independence, because of 
that expert's institutional affiliation or for other reasons.  Similarly, the fact that JECFA may select its 
experts according to strict procedures does not in its elf ensure that these expe rts are independent and 
impartial in respect of the issues that may arise in a WTO dispute.   
460. Not only did Drs. Boisseau and Boobis participat e in JECFA, they were directly involved in 
JECFA's evaluations of the six hormones at issue.   Dr. Boisseau was a member of JECFA in 1987 
when the Committee evaluated oestradiol-17 β, progesterone, testosterone, trenbolone acetate, and 
zeranol.944  Both Drs. Boisseau and Boobis were memb ers of JECFA in 1999 when it again evaluated 
oestradiol-17 β, progesterone, and testosterone.  During its 1999 session, JECFA adopted 
recommended Acceptable Daily Intakes ("ADIs") for oestradiol-17 β, testosterone, and 
progesterone.945  The report of the 1999 session lists Dr. Boisseau as the Chairman and Dr. Boobis as 
one of two Joint Rapporteurs.  Drs. Boisseau and Bo obis also participated in the evaluation of MGA 
in 2000.946  On this occasion, the relevant JECFA re port lists Dr. Boisseau as Vice-Chairman and 
Dr. Boobis as a Joint Rapporteur.947  Thus, Dr. Boisseau was a memb er of JECFA when it evaluated 
all six hormones at issue in this dispute, while Dr. Boobis participated in the evaluation of four of the 
six hormones.  As Chairman, Vice-Chairman, and Jo int Rapporteur, they would be expected to have 
played a significant role in the discussions. 
461. Rather than being a source of concern, the Pa nel considered that Drs. Boisseau's and Boobis' 
participation in JECFA would make them more useful as experts: 
                                                      
943European Communities' appellant's submission, para. 196. 
944JECFA, "Evaluation of Certain Drug Residues in Food", 32nd Report, 1988 (Exhibit US-25 
submitted by the United States to the Panel in US – Continued Suspension ). 
945JECFA, "Evaluation of Certain Drug Residues in Food", 52nd Report, 2000.  The Committee did not 
specify MRLs for these three hormones because it found th at "available data on the identity and concentration of 
residues of the veterinary drug in animal tissues indicat e a wide margin of safety for consumption of residues in 
food when the drug is used according to good practice in the use of vete rinary drugs".  Thus, the Committee 
"concluded that the presence of drug residues in the named animal product does not present a health concern and 
that there is no need to spec ify a numerical MRL". (JECFA, 52nd Report, p. 101, footnote 1 (Exhibit US-5 
submitted by the United States to the Panel in US – Continued Suspension ))  
946Dr. Boobis also participated in the evaluation of MGA in 2004 (JECFA, "Evaluation of Certain Drug 
Residues in Food", 62nd Report, 2004 (Exhibit CDA-20 submitted by Canada to the Panel in Canada – 
Continued Suspension )). 
947JECFA, "Evaluation of Certain Drug Residues in Food", 54th Report, 2001 (Exhibit US-24 submitted 
by the United States to the Panel in US – Continued Suspension ). WT/DS321/AB/R 
Page 192  
 
The Panel chose not to exclude  a priori  experts who had 
participated in the preparation and drafting of JECFA's risk assessments  because this would deprive the Panel and the parties of 
the benefit of the contribution of internationally recognized specialists and because the Panel was of the opinion that experts 
familiar with the JECFA reports would be well-placed to assist the 
Panel in understanding the work of JECFA extensively referred to by 
the parties in their submissions, in particular by the European 
Communities.
948   
462. The Panel also observed that "since JECFA's risk  assessments were used as the reference risk 
assessments for purposes of the analysis under Article 5.7 of the  SPS Agreement , it was necessary for 
the Panel to be able to rely on the advice of e xperts intimately knowledgeable about the substance of 
JECFA's risk assessments."949  We are not persuaded by the Panel's reasoning.  It is precisely because 
JECFA's risk assessments have such a prominent ro le in this dispute that the Panel should have 
exercised particular caution before appointing persons with institutiona l links to JECFA as experts.  
The Panel gave the experts wide latitude in terms of  their examination of the evidence and the advice 
they provided.  Given how the Panel framed its cons ultations with the experts, it would have been 
very difficult for it to limit the scope of the a dvice it received from Drs. Boisseau and Boobis to the 
"work of JECFA".  In fact, our review of the panel record indicates that the Panel did not limit its 
consultations with Drs. Boisseau and Boobis to the "work of JECFA".950  For example, as regards the 
European Communities' permanent ban on meat  from cattle treated with oestradiol-17 β, the Panel 
asked the experts (including Drs. Boisseau and Boobis): 
To what extent, in your view, does the [European Communities'] risk 
assessment identify the potential for adverse effects on human health, 
including the carcinogenic or genotoxic potential, of the residues of oestradiol-17 β found in meat derived from cattle to which this 
hormone had been administered for growth promotion purposes in accordance with good veterinary prac tice?  To what extent does the 
[European Communities'] risk assessment evaluate the potential 
occurrence of these adverse effects?
951 
                                                      
948Panel Report, US – Continued Suspension , para. 7.85;  Panel Report, Canada – Continued 
Suspension , para. 7.83. (footnote omitted)  
949Panel Report, US – Continued Suspension , para. 6.62;  Panel Report, Canada – Continued 
Suspension , para. 6.57. 
950The Panel posed 62 written questions to the six scien tific experts.  Dr. Boisseau provided responses 
to 59 questions and Dr. Boobis replied to 45.  These stand in sharp contrast to the other experts who provided responses to far fewer questions.  Dr. Brabander replied to 17 questions, Dr. Cogliano answered 12 questions, 
Dr. Guttenplan responded to 31 questions, and Dr. Sippel gave responses to 4 questions.  (See Panel record 
document, Statistics on Replies of the Scientific Experts )  We do not mean to suggest that it is problematic for an 
expert to answer too many questions.  We refer to thes e numbers merely to illustrate the breadth of the advice 
provided by Drs. Boisseau and Boobis in this case. 
951Panel Reports, Annex D, p. D-22, Question 13.  WT/DS321/AB/R 
 Page 193 
 
 
463. This question goes directly to the adequacy of the European Commun ities' risk assessment 
and does not concern JECFA's work.  Both Drs. Bo isseau and Boobis responde d to this question and 
their responses were relied on by the Panel in its analysis: 
Dr. Boisseau concluded that the European Communities did not 
demonstrate that a potential for adverse effects on human health arises from the consumption of meat  from cattle treated with any of 
the six hormones in dispute for growth promotion purposes.
952 
Dr. Boobis stated that, in his view, none of the information provided 
by the European Communities demonstrates the potential for adverse effects in humans of any of the six hormones in meat from cattle in which they are used for growth promotion purposes at the levels to 
which those consuming such meat would be exposed.  The studies on 
genotoxicity provide no convincing evidence of potential for harm in consumers.  The carcinogenic effects observed are entirely consistent with a hormonal mode of action that exhibits a threshold that would be well above the intake arising from consumption of meat from treated cattle.
953 
In their replies, Drs. Boisseau and Boobis direct ly evaluated the appropriateness of the European 
Communities' risk assessment. 
464. The Panel also asked the experts whether the European Communitie s' risk assessment 
examined the risks arising specifically from the cons umption of meat from cattle treated with the six 
hormones at issue: 
Do the risk assessment of the Eu ropean Communities or any other 
scientific materials referred to  by the European Communities 
demonstrate that a potential for adverse effects on human health arises from the consumption of meat  from cattle treated with any of 
the six hormones in dispute for growth-promotion purposes?  If yes, why?  If not, what kind of evidence would be required to demonstrate 
such potential adverse effects?  Would your response have been 
different at the time of a doption of the Directive in 
September 2003?
954 
465. The question concerns the specificity require ment discussed by the Appellate Body in EC – 
Hormones .955  Drs. Boisseau and Boobis both volunteered responses, and the Panel again relied on 
                                                      
952Panel Report, US – Continued Suspension , para. 7.526;  Panel Report, Canada – Continued 
Suspension , para. 7.498 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 406). 
953Panel Report, US – Continued Suspension , para. 7.527;  Panel Report, Canada – Continued 
Suspension , para. 7.499 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 408). 
954Panel Reports, Annex D, p. D-84, Question 52. 
955Appellate Body Report, EC – Hormones , para. 199. WT/DS321/AB/R 
Page 194  
 
both of their replies in its examina tion of the consistency with the  SPS Agreement  of the European 
Communities' risk assessment.  The Panel summa rizes the response of Dr. Boisseau as follows: 
Dr. Boisseau concluded that the European Communities did not 
demonstrate that a potential for adverse effects on human health 
arises from the consumption of meat  from cattle treated with any of 
the six hormones in dispute for growth promotion purposes.  Additionally, Dr. Boisseau stated that the kind of evidence required to demonstrate such potential adverse effects should be (a) toxicological data indicating that the values of the ADIs established 
by JECFA are not conservative enough, and (b) data on residues in 
treated/non-treated cattle and on daily production of  hormones in 
sensitive individuals [such as pre-pubertal children] indicating that the hormonal residue intake associated with the consumption of meat from treated cattle is such that the established ADIs would be 
exceeded in the case of use of growth promoters.
956 
466. This excerpt is a good illustration of the problem s arising from Drs. Boisseau's and Boobis' 
involvement with JECFA's evaluation of the hormon es at issue in this dispute.  Dr. Boisseau's 
response shows that he considered JECFA and, in  particular, its approach of using ADIs, as the 
benchmark against which to evaluate th e European Communities' risk assessment.957   
467. Another illustration of this problem can be seen  in Dr. Boisseau's response to the Panel's 
question regarding whether the scientific evidence in the SCVPH Opinions supported the conclusion 
that the carcinogenic effects of th e hormones at issue are related to  a mechanism other than hormonal 
activity.958  For each of the hormones at issue, except for oestradiol-17 β (in respect of which he 
referred to an earlier response), Dr. Boisseau comp ared the European Comm unities' risk assessment 
with JECFA's conclusions.  For example, Dr. Bois seau gave the following response in relation to 
progesterone: 
In its thirty second session, JE CFA concluded that "Although 
equivocal results have been repor ted for the induction of single-
strand DNA breaks and DNA adducts have been seen in vivo and in 
vitro in some studies, progesterone was not mutagenic … progesterone has no genotoxic potential".  It concluded also that "these effects on tumour production occurred only with doses of progesterone causing obvious hormona l effects … th e effects of 
progesterone on tumour production was directly related to its 
hormonal activity". 
                                                     
 
956Panel Report, US – Continued Suspension , para. 7.526;  Panel Report, Canada – Continued 
Suspension , para. 7.498 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 406). 
957This excerpt also shows th at there is a problem in the standard  applied by the Panel to review the 
European Communities' risk assessment.  We di scuss this in section VII.E of this Report. 
958Panel Reports, Annex D, p. D-27, Question 16.  WT/DS321/AB/R 
 Page 195 
 
 
In its 1999 report, SCVPH concluded,  about the carcinogenicity of 
progesterone, that "At present, the data are insufficient to make any quantitative estimate of the risk arising from the exposure to residues in meat"[.]  Therefore,   the scientific evidence relied upon in the 
SCVPH Opinions does not support the conclusion that the 
carcinogenic effects of progesterone are related to a mechanism other 
than hormonal activity.
959 
The response in relation to testosterone is similar: 
In its thirty second session, JECFA concluded that the increase of the 
incidence of prostactic and uter ine tumours observed in rodents 
treated with high doses of testosterone ["]resulted from the hormonal activity of testosterone".  In its fifty second session held in 1999, 
JECFA concluded that "In mammalian cells, no chromosomal 
aberrations, mutations or DNA adducts were found following treatment with testosterone … testosterone has no genotoxic 
potential". 
In its 1999 report, SCVPH concluded,  about the carcinogenicity of 
testosterone, that, given the lim ited data on genotoxicity and on 
carcinogenicity in humans, no conc lusive quantitative estimate of the 
risk arising from the excess intake with meat from treated animals can be made.  Therefore,   the scientific evidence relied upon in the 
SCVPH Opinions does not support the conclusion that the carcinogenic effects of testosterone are related to a mechanism other 
than hormonal activity.
960 
Both of these responses are cited in the Panel's reasoning.961  Dr. Boisseau also drew a comparison 
with JECFA at the end of his response, when he summarized his views as follows: 
[C]onsidering the conclusions of JECFA and the fact that SCVPH 
bases always its reservations on the lack of data more than on data 
establishing the genotoxicity and the capacity of the five other 
hormones (progesterone, testoster one, melengestrol, trenbolone and 
zeranol) to act as complete carcinogens, it can be said that the scientific evidence relied upon in  the SCVPH Opinions does not 
support the conclusion that the carcinogenic effects of these five 
hormones are related to a mechan ism other than hormonal activity.
962 
468. A similar problem can be seen as regards the question of the sufficiency of the evidence under 
Article 5.7 of the  SPS Agreement .  At the meeting with the Panel and the parties, the United States 
asked the experts whether they considered that the scientific evidence re lied on by the European 
                                                      
959Panel Reports, Annex D, paras. 157 and 158. 
960Ibid., paras. 159 and 160. 
961Panel Report, US – Continued Suspension , para. 7.732 and footnote 859 thereto, para. 7.738 and 
footnote 865 thereto, and para. 7.752 and footnote 878 thereto;  Panel Report, Canada – Continued Suspension , 
para. 7.709 and footnote 807 thereto, para. 7.715 and footnote 813 thereto, and para. 7.731 and footnote 828 
thereto. 
962Panel Reports, Annex D, para. 167. WT/DS321/AB/R 
Page 196  
 
Communities in the SCVPH Opinions supported the c onclusion that it is not possible to complete a 
risk assessment for the five hormones that are the subject of the provisional ban.
963  Dr. Boobis 
referred to his experience in JECFA, replying: 
I cannot speak for the [European Communities], and I think what has 
just been said is quite correct.  I can speak for JECFA in which I 
participated, and in our view we had enough information to complete 
a risk assessment.  I don't know if that is helpful, but that was the 
situation when we looked at the available data on those five other hormones.
964 
469. The European Communities, however, based mu ch of its case before the Panel on the 
limitations of JECFA's approach.  Given that in  its own risk assessment the European Communities 
called into question the validity of JECFA's risk as sessments, it was improper for the Panel to have 
asked Drs. Boisseau and Boobis, who participated di rectly in JECFA's evaluations, to evaluate the 
European Communities' risk assessme nt.  The natural inclination of someone placed in that situation 
would be to compare the risk asse ssments, rather than to assess wh ether the science relied upon by the 
European Communities can support the conclusions it reached, and to favour or defend JECFA's 
approach.  The manner in which the Panel used th ese experts does not ensure impartiality and cannot 
be said to ensure fairness in the consultations with the experts.  Such a result is not compatible with 
the due process obligations that are inherent in the WTO dispute settlement system. 
470. Canada argues that it is "incorrect to portr ay" the participation in JECFA panels by 
Drs. Boisseau and Boobis as "giving them an (alm ost proprietary) interest in the outcome of the 
JECFA process that they would have felt compelled to defend".965  Canada maintains that the JECFA 
process "is a diffuse one, in which a number of scientists participate" and is "aimed at reaching a consensus out of what may initially be a variety of scientific views".
966  Therefore, Canada argues, 
"the process is very different from scientific conclu sions arrived at by one individual's scientific 
efforts that are published under his or her name"967, and Drs. Boisseau and Boobis were no more 
responsible for authoring the JECFA reports than was any other "expert participating in a JECFA 
meeting and subscribing to a resulting report [which ] might be considered part of the collective 
authorship of the scientists involved."968  At the oral hearing, Canada additionally noted that, at 
JECFA meetings, the experts reviewed previously prepared monographs that, in this case, did not 
contain the input of Drs. Boisseau and Boobis. 
                                                      
963Panel Reports, Annex G, para. 770. 
964Ibid., para. 774. 
965Canada's appellee's submission, para. 56. 
966Ibid. 
967Ibid. 
968Ibid., para. 52.  WT/DS321/AB/R 
 Page 197 
 
 
471. The Panel also reasoned that Drs. Boisseau and Boobis may have contributed to the 
development of JECFA reports, but the nature of th eir participation ensured that they could remain 
independent and impartial.  In  response to objections from the European Communities during the 
interim review, the Panel explained: 
Moreover, JECFA reaches its conclu sions by consensus.  So the 
opinions expressed by the two experts were given with regard to the consensual view of JECFA on this matter, not just their own personal positions in the past.  This does not mean, however, that JECFA's 
work is these particular experts' own work:  it is a joint work by 
several experts.
969 
472. We recognize that JECFA involves a decisi on-making process based on consensus and that 
the outcome of the process need not necessarily re flect the views of its individual members.  
However, the fact that this process involves several individuals and that the outcome may be the result 
of a compromise does not mean that the joint out come of the process can be disconnected from the 
experts that participated in the process.970  On the contrary, one would expect that the views of the 
experts that participated in the process would be reflected, in various degrees, in the outcome.  As 
noted earlier, Drs. Boisseau's and Boobis' participat ion was not indirect or marginal.  Rather, both 
would be expected to have had particular infl uence in the process given their respective roles as 
Chairman and Vice-Chairman, and Joint Rapporteur.  Moreover, irrespective of their degree of influence in the process, both would be expected to  have a natural inclina tion to identify with 
JECFA's evaluation as participants in the consensus.  Therefore, we do not consider that the fact that 
JECFA reaches its conclusions by consensus dispels our concerns regarding th e propriety of the Panel 
asking Drs. Boisseau and Boobis to evaluate th e European Communities' risk assessment.   
                                                     
 
969Panel Report, US – Continued Suspension , para. 6.62;  Panel Report, Canada – Continued 
Suspension , para. 6.57. 
970In the meeting with the Panel and the parties, Dr . Boobis suggested that JECFA had been operating 
since 1997 on the basis of unanimity.  Dr. Boobis' description of JECFA decision-making does not support Canada's argument that JECFA reports may not necessarily  reflect the views of Drs.  Boisseau and Boobis.  
Dr. Boobis explained: 
The JECFA Committee—at least as far back as 1997—have been able to 
reach an agreed position on all the ques tions before them.  In the event that 
there was a disagreement, there would be two possible options – one would 
be not to proceed further and seek further evidence, and the other would be, as has been indicated already by the s ecretariat, if the majority was of one 
view and a minority was of another view, to issue a so-called minority 
opinion or minority report as well, which reflects a contrary view on the 
interpretation of the data.  As I said earlier, this has not happened, there was 
unanimity.  Generally what happens is that there is a discussion, there may be varying interpretations of a dataset, the experts get together over the 
period of a meeting and explore the various possibilities, bringing new 
information, or new insights and reach a common position, and that has worked generally very successfully in the evaluation of the compounds over 
the last 10 years I have been involved in JECFA.   
(Panel Reports, Annex G, para. 511) WT/DS321/AB/R 
Page 198  
 
473. The United States emphasizes the fact that the Panel consulted with the parties when it 
adopted the Experts Working Procedures and in the expert selection process.
971  We agree with the 
United States that consultation with the parties in  the adoption of working procedures for selecting the 
experts and in the expert selection process is a mean s for ensuring that the parties' due process rights 
are respected.  However, as we explained earlier, th e obligation to afford the protection of due process 
to the parties is not circumscribed to the expert selection stage and does not end with the appointment 
of the experts.  Due process protection continues to apply throughout the consultations with the 
experts.  Thus, the fact that the Panel may have c onsulted with the parties in  this case when preparing 
the Experts Working Procedures and in selecting the experts does not provide a basis for concluding 
that due process was also respected in the sub sequent stages of the proceedings, including the 
consultations with the experts.  Moreover, in the cons ultations that the Panel held with the parties, the 
European Communities repeatedly objected to th e selection of experts affiliated with JECFA.972 
474. The Panel additionally expressed the view that Dr s. Boisseau and Boobis, by virtue of their 
work as scientists, could be relied upon to be object ive in their assessment of critiques of their work, 
as well as of new scientific evidence that might requi re altering the conclusions of their prior work.  
During the interim review stage, the Panel res ponded to objections of the European Communities as 
follows: 
[S]cientists would readily admit that science is constantly evolving 
and the fact that new studies are peer reviewed is evidence that 
assessing new ideas and findings is part of scientific work. Assuming that scientists may lack objectivity because they participated in the 
preparation and drafting of JECFA's risk assessments on the 
hormones at issue would call into question the whole principle of peer review.
973  
475. The Panel added: 
The experts that the European Co mmunities claims were defending 
their work acknowledge that the st ate of knowledge can evolve. ... 
The experts consulted by the Panel are used to considering and peer 
reviewing studies that go beyond what they have published 
themselves or perhaps even contradict them.  In other words, they are not likely to feel any need to defe nd their own previous work results 
                                                     
 
971United States' appellee's submission, para. 85. 
972Panel Report, US – Continued Suspension , para. 7.79;  Panel Report, Canada – Continued 
Suspension , para. 7.77 (referring to the European Communities' comments on the proposed experts of 
16 January 2006).  
973Panel Report, US – Continued Suspension , para. 6.22;  Panel Report, Canada – Continued 
Suspension , para. 6.21.  WT/DS321/AB/R 
 Page 199 
 
 
in the light of new, convincing evidence or techniques that put such previous work into doubt.
974 
476. The European Communities argues that  the principle of peer review is not found in any of the 
WTO agreements, and that scientific journals "re quire that new work submitted for publication must 
not be given for review by the same persons  whose theories the submitted articles contest".975  The 
key question, the European Communities maintains, is "whether an expert that has been the author of 
a given report is impartial and independent to act  as a 'peer' in 'reviewing' reports that explicitly 
criticise the report where the 'peer' is a co-author."976 
477. We recognize that scientists will often be asked to review studies performed by other 
scientists and that the scientific community must cons tantly reassess theories in the light of scientific 
progress.  However, as we pointed out above, the Panel did not simply ask Drs. Boisseau and Boobis 
about JECFA's work and risk assessments.  In th e consultations with experts, the Panel asked 
Drs. Boisseau and Boobis to evaluate the Europ ean Communities' risk assessment and they did so 
using JECFA's evaluations as a benchmark.  This is problematic in this case because the European 
Communities' risk assessment called into question th e validity of JECFA's evaluations and explicitly 
stated that it would not follow them.  In the light of this, it was improper for the Panel to consult with 
Drs. Boisseau and Boobis, who were directly involv ed in JECFA's evaluations.  The concerns raised 
in this situation are not addressed by the fact that  scientists regularly conduct "peer reviews" or may 
recognize that science evolves.  Nor are the conc erns addressed by the Panel's explanation that 
JECFA's work is linked to Codex, which is expressly recognized by the  SPS Agreement  as having 
responsibilities for the "establishment of interna tional standards, guidelines and recommendations".977   
478. The Panel also referred to the presumption of consistency that applies to SPS measures based 
on international standards under Articles 3.1 and 3.2 of the  SPS Agreement  as an additional 
justification for its appointment of Drs. Boisseau and Boobis because of their involvement in the risk 
assessments underlying the international standards at issue in this case.  However, we fail to see why 
the appointment of such experts would be justified in a case such as this one where the WTO Member 
adopts a higher level of protection than that refl ected in the international standards, pursuant to 
Article 3.3.  The Panel's view that it is consistent  with JECFA's role in setting international standards 
"for the Panel to rely on experts who contributed in the preparation and drafting of JECFA's risk 
                                                      
974Panel Report, US – Continued Suspension , paras. 6.62 and 6.63;  Panel Report, Canada – Continued 
Suspension , paras. 6.57 and 6.58. 
975European Communities' appellant's submission, para. 199. 
976Ibid. 
977Panel Report, US – Continued Suspension , para. 6.22;  Panel Report, Canada – Continued 
Suspension , para. 6.21. WT/DS321/AB/R 
Page 200  
 
assessments on the substances at issue"
978 rather confirms our impression that the Panel improperly 
relied on Drs. Boisseau and Boobis to evaluate th e European Communities' risk assessment against 
the evaluations conducted by JECFA.979 
479. Accordingly, we consider that it was imprope r for the Panel to consult Drs. Boisseau and 
Boobis.  We reiterate that our concerns do not relate  to the qualifications of Drs. Boisseau and Boobis, 
who are highly recognized experts, nor do they relate to the fact that, as experts, they would have been 
expected to hold views on issues in their area of e xpertise.  Rather, our concerns arise from their 
direct involvement in the risk assessments perform ed by JECFA for the hormones at issue in this 
dispute and from the particular role that JECFA' s risk assessments, and the Codex standards adopted 
on the basis of those risk assessments, ha d in this case.  As we noted earlier980, in its case before the 
Panel, the European Communities argued that ther e were limitations in JECFA's evaluation of 
oestradiol-17 β and that the evidence relied upon by JECFA in the evaluation of the other five 
hormones was outdated.  The Panel, for its part, c onsidered that the existe nce of an international 
standard established a presumption that the scientific evidence was not "insuffici ent" to perform a risk 
assessment within the meaning of Article 5.7 of the  SPS Agreement .981   
480. We understand that panels often face practical difficulties in selecting experts who have the 
required level of expertise and whose selection is not objected to by the parties.982  We do not wish to 
make the expert selection process more difficult than  it may already be.  However, experts consulted 
by a panel can have a decisive role in a case, esp ecially when it involves highly complex scientific 
questions such as this one.  The Panel in this case  said "the role of the experts was to act as an 
'interface' between the scientific ev idence and the Panel, so as to allow it to perform its task as the 
trier of fact."983  Experts appointed by a panel can signifi cantly influence the decision-making process.  
If a panel does not ensure that the requirements of independence and impartiality are respected in its 
                                                      
978Panel Report, US – Continued Suspension , para. 6.22;  Panel Report, Canada – Continued 
Suspension , para. 6.21. 
979Panel Report, US – Continued Suspension , para. 6.63;  Panel Report, Canada – Continued 
Suspension , para. 6.58. 
980See supra , para. 458. 
981See supra , para. 940. 
982The Panel described some of the difficulties it encountered in this case: 
The Panel wishes to highlight the challenges it encountered in selecting 
experts.  There was a limited number of specialists suggested and actually 
available in each of the fields on which the Panel needed assistance and 
almost always one or more of the par ties objected to that specialist.  For 
example, only six of the identified ava ilable experts were deemed to have 
extensive expertise in risk analysis.  A ll of these experts were objected to by 
at least one party. 
(Panel Report, US – Continued Suspension , footnote 382 to para. 7.87;  Panel Report, Canada – Continued 
Suspension , footnote 374 to para. 7.85) 
983Panel Report, US – Continued Suspension , para. 6.72;  Panel Report, Canada – Continued 
Suspension , para. 6.67.)  WT/DS321/AB/R 
 Page 201 
 
 
consultations with the experts, this can comp romise the fairness of the proceedings and the 
impartiality of the decision-making.  In these circum stances, the practical difficulties that a panel may 
encounter in selecting experts cannot displace the n eed to ensure that the consultations with the 
experts respect the parties' due process rights. 
481. For these reasons, we consider that there was an objective basis to conclude that the  
institutional affiliation with JECFA of Drs. Boissea u and Boobis, and their participation in JECFA's 
evaluations of the six hormones at issue, was likely to affect or give rise to justifiable doubts as to 
their independence or impartiality given that the ev aluations conducted by JECFA lie at the heart of 
the controversy between the parties.  The appoint ment and consultations with Drs. Boisseau and 
Boobis compromised the adjudicative independence and im partiality of the Panel.  Therefore, we  find  
that the Panel infringed the European Communities' due process rights as a result of the Panel having 
consulted with Drs. Boisseau a nd Boobis as scientific experts.   
482. Because the appointment and consultations with  Drs. Boisseau and Boobis compromised the 
Panel's ability to act as an independent adjudicat or, the Panel cannot be said to have made "an 
objective assessment of the matter" as required by Article 11 of the DSU.  We recall that, in US – 
Gambling , the Appellate Body held that "as part of thei r duties, under Article 11 of the DSU, to 'make 
an objective assessment of the matter' before them, panels must ensure that the due process rights of 
parties to a dispute are respected."984  Consequently, we find  that the Panel failed to comply with its 
duties under Article 11 of the DSU, as a result of the appointment and consultations with 
Drs. Boisseau and Boobis in the circumstances of this case. 
483. The European Communities argues that, if we were  to find that the Panel erred in relying on 
the advice of Drs. Boisseau and Boobis, we would ha ve to reverse all of the Panel's findings under the 
SPS Agreement .985  At the oral hearing, the United States and Canada disagreed that this would be the 
necessary consequence of our making the finding requested by the European Communities.   
484. Where a panel's ability to act as an independe nt adjudicator has been compromised, as we 
have found in this case, this raises serious issues as to whether the panel's findings may be sustained.  
We recall, moreover, that Drs. Boisseau and Boobi s provided responses to the majority of questions 
posed by the Panel and the Panel relied extens ively on their responses in its assessment of the 
consistency of Directive 2003/74/EC with Articles 5.1 and 5.7 of the SPS Agreement .986  Thus, the 
Panel's findings on Articles 5.1 and 5.7 of the SPS Agreement  would be difficult to sustain upon
                                                      
984Appellate Body Report, US – Gambling , para. 273. 
985European Communities' appellant's submission, paras. 181, 182, and 212. 
986See supra , footnote 950. WT/DS321/AB/R 
Page 202  
 
exclusion of the testimony of Drs. Boisseau and Boobis, assuming that disentangling their testimony 
from the other elements of the Panel's analysis  was possible.  Although our finding on this issue 
could, by itself, lead to the invalidation of th e Panel's findings under Ar ticles 5.1 and 5.7 of the   SPS 
Agreement , we nevertheless proceed to examine the other claims of error raised by the European 
Communities in respect of the Panel's assessment of the consistency of Directive 2003/74/EC with the 
SPS Agreement .  The significance to the Panel's analysis of the testimony of Drs. Boisseau and Boobis 
will become more evident from our review of the Panel's findings under Articles 5.1 and 5.7 of the 
SPS Agreement . 
VI. The Consistency with Article 5.1 of the  SPS Agreement   of the European Communities' 
Import Ban on Meat from Cattle Treated with Oestradiol-17 β for Growth-Promotion 
Purposes 
A. Introduction 
485. We turn next to the European Communities' a ppeal of the Panel's finding that the permanent 
ban on meat and meat products from cattle treated with oestradiol-17 β for growth-promotion purposes 
provided for in Directive 2003/74/EC does not meet the requirements of Article 5.1 of the  SPS 
Agreement .  Section B provides a summary of the Eur opean Communities' risk assessment in relation 
to oestradiol-17 β, which the European Communities conte nds brought it into compliance with the 
recommendations and rulings of the DSB in  EC – Hormones .  This is followed by a summary of the 
Panel's findings under Article 5.1 of the  SPS Agreement  in section C and of the claims and 
arguments raised on appeal in section D.  We then analyze in section E the specific issues raised by 
the European Communities' appeal against the Panel's assessment of Directive 2003/74/EC under 
Article 5.1 of the  SPS Agreement .  Finally, our conclusions are set out in section F. 
486. We recall that the Panel found that the Europ ean Communities' claim unde r Article 23.1, read 
together with Articles 22.8 and 3.7 of the DSU, was premised on the " conformity  (presumed or actual) 
with the  SPS Agreement "
987 of Directive 2003/74/EC.  This is b ecause, in the Panel's view, the phrase 
"until such time as the measure found to be inconsis tent ... has been removed" in Article 22.8 implies 
that what is to be achieved is not the removal of the measure, but actual compliance with the DSB's 
recommendations and rulings.988  For this reason, the Panel considered that it had to address the 
consistency of Directive 2003/74/EC with Articles 5.1 and 5.7 of the  SPS Agreement . 
                                                      
987Panel Report, US – Continued Suspension , para. 7.272;  Panel Report, Canada – Continued 
Suspension , para. 7.288. (original emphasis) 
988Panel Report, US – Continued Suspension , para. 7.284;  Panel Report, Canada – Continued 
Suspension , para. 7.300.  WT/DS321/AB/R 
 Page 203 
 
 
B. The European Communities' Risk Assessmen t for Meat from Cattle Treated with 
Oestradiol-17 β 
487. We recall that, in EC – Hormones , the European Communities' import ban on meat and meat 
products from cattle treated with  six hormones—oestradiol-17 β, testosterone, progesterone, 
trenbolone acetate, zeranol, and MG A—was found to be in consistent with Article 5.1 of the  SPS 
Agreement .  The Appellate Body found that the scien tific studies submitted by the European 
Communities in that dispute were not "sufficiently specific to the case at hand"989, because they were 
"general studies which do indeed show the existence of  a general risk of cancer;  but they do not focus 
on and do not address the particular kind of risk here  at stake—the carcinogenic or genotoxic potential 
of the residues of those hormones found in meat de rived from cattle to which the hormones had been 
administered for growth promotion purposes."990  For this reason, the Appellate Body concluded that 
"no risk assessment that reasonably support[ed] or warrant[ed] the import prohibition embodied in the 
[European Communities'] Directives was furnished to the Panel"991, and accordingly found that the 
European Communities' import ban, imposed under Directive 96/22/EC, was not "based on" a risk 
assessment within the meaning of Article 5.1.  
488. Following the adoption by the DSB of the Panel and Appellate Body Reports in EC – 
Hormones , the European Commission initiated and f unded 17 scientific studies to evaluate the 
potential for adverse effects to human health from residues in bovine meat and meat products 
resulting from the use of oestradiol-17 β, progesterone, testosterone, zeranol, trenbolone acetate, and 
MGA in cattle for growth-promotion purposes.  The results of these studies, as well as other publicly 
available information and data co llected from international organizations such as Codex and JECFA 
were reviewed by the SCVPH.992 
489. On 30 April 1999, the SCVPH published an Opin ion entitled "Assessment of Potential Risks 
to Human Health from Hormone Residues in Bovine Meat and Meat Products"993 (the "1999 
Opinion").  The 1999 Opinion found that "consump tion of beef from hormone-treated non-pregnant 
cattle can result in excess exposure to oestrogens"994 and that the "toxicological issues of concern" 
arising from such excess exposure include "endocrine, developmental, immunological,
                                                      
989Appellate Body Report, EC – Hormones , para. 200.   
990Ibid. 
991Ibid., para. 208.  
992Panel Report, US – Continued Suspension , para. 2.3;  Panel Report, Canada – Continued 
Suspension , para. 2.3. 
993See supra , footnote 20. 
9941999 Opinion, p. 36.  WT/DS321/AB/R 
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neurobiological, immunotoxic, genotoxic and carcinogenic effects."
995  The 1999 Opinion reached the 
following conclusions in relation to the potenti al risks to human health from residues of 
oestradiol-17 β in bovine meat: 
- In summary, 17 β-oestradiol has genotoxic996 potential.  Evidence is building 
that oestrogens, most likely through oxidative metabolism to catechols and 
beyond to semiquinones and quinones, are DNA reactive and mutagenic.997 
- ... in consideration of the recent da ta on the formation of genotoxic 
metabolites of oestradiol, suggesting that 17 β-oestradiol acts as complete 
carcinogen, by exerting tumour initiating and promoting effects, it has to be 
concluded, that no quantitative estimate of the risk related to residues in meat 
could be presented.998 
- These observations strongly suggest that environmental 17 β-oestradiol can, 
even when administered at very low doses, modulate growth of children of 
both sexes and decrease the age when final height is achieved and puberty is reached.
999 
- ... it is suggested that environmental 17 β-oestradiol could exert deleterious 
effects on fertility in men and women, by acting through various, direct and indirect, mechanisms.
1000 
- ... at relatively high doses oestradiol does produce a number of adverse 
effects on the immune system in humans e.g. allergy to topical oestradiol 
(Boehnke and Gall, 1996).  The above findings while indicating a possible 
concern are insufficient to identify whether immune effects could occur in consumers from the ingestion of m eat or meat products containing 17 β-
oestradiol residues.
1001  
                                                      
9951999 Opinion, p. 39.  
996See supra , footnote 156. 
9971999 Opinion, p. 41.  Mutagenicity is the ability of a physical, chemical, or biological agent to 
induce heritable changes (mutations) in the genetic material in a cell as a consequence of alterations or loss of 
genes or chromosomes (or parts thereof).  Panel Report, US – Continued Suspension , footnote 673 to 
para. 7.549;  Panel Report, Canada – Continued Suspension , footnote 623 to para. 7.517 (referring to replies of 
the experts to Question 2 posed by the Panel to the scientific experts, Panel Reports, Annex D, paras. 34 
and 55). 
9981999 Opinion, p. 43.  
999Ibid. 
1000Ibid., p. 44.  
1001Ibid., p. 45.   WT/DS321/AB/R 
 Page 205 
 
 
490. The 1999 Opinion also reached the following co nclusions as to the relevant risks to human 
health posed by the six hormones, and in particular by oestradiol-17 β:  
- As concerns excess intake of hormone residues and their metabolites, and in 
view of the intrinsic properties of hormones and epidemiological findings, a risk to the consumer has been identifie d with different leve ls of conclusive 
evidence for the [six] hor mones in question.   
- In the case of oestradiol-17 β, there was a substantial body of recent evidence 
suggesting that it had to be considered as a complete carcinogen, as it exerted both tumour initiating and tumour promoting effects.  The data available did not, however, allow a quantitative estimate of the risk.  
   ... 
- For all six hormones endocrine, developmental, immunological, 
neurobiological, immunotoxic, genotoxi c and carcinogenic effects could be 
envisaged.  Of the various susceptible risk groups, pre-pubertal children was the group of greatest concern.  Again the available data did not enable a 
quantitative estimate of the risk. 
- In view of the intrinsic properties of the hormones and in consideration of 
epidemiological findings, no threshold leve ls could be defined for any of the 
six substances.
1002 
491. Subsequent to the adoption of the 1999 Opini on, additional scientific information was made 
available to the European Commission, in the fo rm of a report by the Committee for Veterinary 
Medicinal Products ("CVMP") of the European Un ion (a subcommittee of the European Medicines 
Agency (EMEA)), and a report by the United Kingd om's Veterinary Products Committee sub-group 
on the 1999 Opinion.  At the request of the Europe an Commission, the SCVPH examined this scientific 
information and, on 3 May 2000, issued a review of its 1999 Opinion in which it declined to alter the 
conclusions contained therein1003 (the "2000 Opinion").  The SCVPH observed that "particularly in 
regards to the subject of estrogen ic effects during [various stages of] development, there is no 
compelling evidence suggesting that these effects do not also occur at low doses."1004  The 2000 Opinion 
concluded that recent  scientific information "d id not provide convincing da ta and arguments demanding 
                                                      
1002Panel Report, US – Continued Suspension , para. 7.391;  Panel Report, Canada – Continued 
Suspension , para. 7.388 (quoting 1999 Opinion, p. 73).  
1003See supra , footnote 21. 
10042000 Opinion, p. 2.  WT/DS321/AB/R 
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revision of the conclusions drawn in the [1999 Opin ion] on the potential risks to human health from 
hormone residues in bovine meat and meat products".
1005 
492. On 10 April 2002, a second review of the 1999 Opinion was issued by the SCVPH1006 (the 
"2002 Opinion"), on the basis of scientific data co llected since the previous review.  The scientific 
data reviewed by the SCVPH included the final results of all 17 studies that had been commissioned by the European Commission, as well as scientific da ta from relevant internat ional organizations and 
other sources.  The SCVPH considered that the data  from the 17 scientific studies and recent scientific 
literature confirmed the validity of the 1999 Opinion,  as reviewed in 2000, and that no amendments to 
those Opinions were justified.
1007  The 2002 Opinion also drew the following conclusions about the 
potential health risks posed by  residues of oestradiol-17 β in meat: 
- Ultra-sensitive methods to detect residues of  hormones in animal tissues have become 
available, but need further validation. 
- Studies on the metabolism of oestradiol-17 β in bovine species indicated the formation 
of lipoidal esters, disposed particularly in body fat. These lipoidal esters showed a 
high oral bioavailability1008 in rodent experiments. Thus, the consequence of their 
consumption needed to be considered in a risk assessment. 
- Experiments with heifers, one of the ma jor target animal gr oups for the use of 
hormones, indicated a dose-dependent increas e in residue levels of all hormones, 
particularly at the implantation sites. Misplaced implants and repeated implanting, 
which seemed to occur frequently, represen ted a considerable risk that highly 
contaminated meats could enter the food chain. ...  
- Convincing data had been published c onfirming the mutagenic and genotoxic 
potential of oestradiol-17 β as a consequence of metabolic activation to reactive 
quinones.  In vitro1009 experiments indicated that oestrogenic compounds might alter 
the expression of an array of genes. Cons idering that endogenous oestrogens also 
                                                      
1005Panel Report, US – Continued Suspension , para. 7.392;  Panel Report, Canada – Continued 
Suspension , para. 7.389 (quoting 2000 Opinion, p. 4).   
1006See supra , footnote 22. 
1007Panel Report, US – Continued Suspension , para. 7.394;  and Panel Report, Canada – Continued 
Suspension , para. 7.391 (referring to 2002 Opinion, pp. 21 and 22).  
1008Bioavailability refers to the capacity of a substance to enter the general blood circulation and to 
diffuse into the human or animal body, or the fraction of a dose of a substance that is available for systemic 
circulation.  See Panel Report, US – Continued Suspension , footnote 508 to para. 7.393;  and Panel Report, 
Canada – Continued Suspension , footnote 499 to para. 7.390 (referring to replies of the experts to Question 43 
posed by the Panel to the scientific experts, Panel Reports, Annex D, paras. 344-357). 
1009See supra , footnote 365.   WT/DS321/AB/R 
 Page 207 
 
 
exert these effects, the data highlighted the diverse biological effects of this class of 
hormones. 
  ... 
- Epidemiological studies with opposite-sexed twins, suggest that the exposure of the 
female co-twin  in utero  to hormones results in an increased birth weight and 
consequently an increased adult breast cancer risk.1010  
493. In light of the conclusions of the 1999, 2000 , and 2002 Opinions, the European Communities 
adopted Directive 2003/74/EC on 22 September 20031011, which amended Directive 96/22/EC.  
Directive 2003/74/EC provides for the  permanent  prohibition on the importation of meat and meat 
products from animals treated with oestradiol-17 β for growth-promotion purposes, on the basis of the 
SCVPH assessment that "recent evid ence suggests that [oestradiol-17 β] has to be considered as a 
complete carcinogen, as it exerts both tumour-initi ating and tumour-promoting effects and that the 
data currently available do not make it possibl e to give a quantitative estimate of the risk."1012  
Directive 2003/74/EC also provides for a provisional  ban on meat and meat products from cattle 
treated with progesterone, testosterone, zeranol , trenbolone acetate and MGA for growth-promoting 
purposes.   
494. Before the Panel, the European  Communities argued that the 1999, 2000, and 2002 Opinions,  
supported by the 17 studies conducted between 1998 a nd 2001, constitute the risk assessment upon 
which Directive 2003/74/EC is based.1013  
C. The Panel's Findings 
495. As noted earlier in section IV of this Repor t, the European Communities has challenged in 
these proceedings the continued application of the suspension of concessions by the United States and 
Canada subsequent to the notification of Direc tive 2003/74/EC.  The European Communities argued, 
inter alia , that Article 22.8 of the DSU permits the a pplication of the suspension of concessions and 
other obligations only until such time as the meas ure found to be inconsis tent with a covered 
agreement has been removed, a condition that it clai ms was met with the adoption and notification of 
                                                      
1010Panel Report, US – Continued Suspension , para. 7.393;  Panel Report, Canada – Continued 
Suspension , para. 7.390.  
1011See supra , footnote 5.  
1012Panel Report, US – Continued Suspension , para. 7.395;  Panel Report, Canada – Continued 
Suspension , para. 7.392 (referring to Directive 2003/74/EC).  
1013Panel Report, US – Continued Suspension , para. 7.389;  Panel Report, Canada – Continued 
Suspension , para. 7.386.  WT/DS321/AB/R 
Page 208  
 
Directive 2003/74/EC.
1014  According to the European Comm unities, the United States and Canada 
acted inconsistently with Article 23.1, read togeth er with Articles 22.8 and 3.7 of the DSU, by failing 
to have recourse to, and abide by, the rules and pr ocedures of the DSU subsequent to the adoption and 
notification to the DSB of Directive 2003/74/EC.  
496. The Panel observed that the European Commun ities' claim under Article 22.8 of the DSU was 
premised on the European Communities' contenti on that Directive 2003/74/EC has brought its import 
ban on meat and meat products from cattle treated with hormones for growth-promotion purposes into 
compliance with the  SPS Agreement .  For this reason, the Panel considered that it had jurisdiction to 
"address the compatibility" of Directive 2003/74/EC with the  SPS Agreement to the extent necessary 
to determine whether the "'measure found to be inconsistent' in the EC – Hormones  case has been 
removed".1015   
497. Turning to the allocation of the burden of proof, the Panel observed, first, that it was 
incumbent upon the European Communities as the complaining party to establish a  prima facie  case 
of a violation of Article 22.8 of the DSU.  The Panel found that the European Communities had met this burden because of the presumption of good faith compliance that the Panel had previously found 
to apply in relation to the Europ ean Communities' implementing measure.
1016  As a result, the burden 
shifted to the responding parties.  The Panel found that the United States and Canada had sufficiently 
refuted, "in [their] first written submission[s] through positive evidence of breach of the  SPS 
Agreement "1017 the European Communities' allegation that  its implementing measure complied with 
the  SPS Agreement .  The Panel further stated that, "[i]n its subsequent submissions before the Panel, 
the European Communities responded to the allegations  of violation made by [the United States and 
Canada]".1018  The Panel added that "[w]hile the presu mptions based on good faith enjoyed by each 
party may have played a role in the burden of proof  in the early stage of the Panel proceedings, it is 
the opinion of the Panel that they eventually 'neu tralized' each other since each party also submitted 
evidence in support of its allegations."1019  The Panel ultimately concluded that "each party had to 
                                                      
1014We discuss the meaning of "removal" supra , section IV.D. 
1015Panel Report, US – Continued Suspension , para. 7.375;  Panel Report, Canada  – Continued 
Suspension , para. 7.372.   
1016Panel Report, US – Continued Suspension , para. 7.385;  Panel Report, Canada  – Continued 
Suspension , para. 7.382.  
1017Ibid. 
1018Ibid. 
1019Panel Report, US – Continued Suspension , para. 7.386;  Panel Report, Canada  – Continued 
Suspension , para. 7.383.  WT/DS321/AB/R 
 Page 209 
 
 
prove its specific allegations in response to evid ence submitted by the other party", and that it had 
"weigh[ed] all the evidence before it"1020 in reaching its findings. 
498. The Panel then explained that it needed to review Directive 2003/74/EC against:  (a) the 
recommendations and rulings of the DSB in the EC – Hormones  case and (b) the provisions with 
which the European Communities purports to comply as part of its claim of violation of Article 22.8 
by the United States and Canada.1021  The Panel acknowledged that in a case such as this it would be 
difficult for the complainant to identify all the pot ential problems of incompatibility.  At the same 
time, the Panel recognized that, in this case, wh ere a finding of violation is conditional on the 
compliance of a measure of the complainant with the WTO agreements, difficulties could arise if the 
scope of review of that measure is defined only by  the complainant.  Indeed, the complainant could 
limit the scope of the panel's review to provisions with which it believes that its measure is most 
likely to be found compatible.1022  Under these circumstances, the Panel found it preferable, both from 
a legal and a practical point of view, to consider  all  the allegations and arguments raised by each 
party, as long as the other party had the opportunity to comment on those allegations and arguments.  
Accordingly, the Panel sought to "circum scribe" the scope of its review under the  SPS Agreement1023, 
on the basis of the claims and arguments raised by each party, and determined that it would review, to 
the extent necessary for assessi ng the European Communities' Article 22.8 claim, the 
"compatibility"1024 of Directive 2003/74/EC with Articles 5.1, 5.21025, 5.7, and 3.3 of the  SPS 
Agreement . 
499. The Panel next outlined the standard that it would apply in reviewing the compatibility of 
Directive 2003/74/EC with those provisions.  The Panel noted that the standard of review applicable 
to legal and factual issues regarding measures reviewed under the  SPS Agreement  is found in 
Article 11 of the DSU and explained that, as regard s the assessment of the facts, this standard has 
been understood as requiring "neither de novo review  as such, nor 'total deference', but rather the 
                                                      
1020Panel Report, US – Continued Suspension , para. 7.386;  Panel Report, Canada  – Continued 
Suspension , para. 7.383.  
1021Panel Report, US – Continued Suspension , para. 7.402;  Panel Report, Canada  – Continued 
Suspension , para. 7.399. 
1022Panel Report, US – Continued Suspension , para. 7.403;  Panel Report, Canada  – Continued 
Suspension , para. 7.400. 
1023Panel Report, US – Continued Suspension , para. 7.398;  Panel Report, Canada  – Continued 
Suspension , para. 7.395. 
1024Panel Report, US – Continued Suspension , para. 7.411;  Panel Report, Canada  – Continued 
Suspension , para. 7.402.  
1025Only the United States argued that Directive 2003/74/EC was inconsistent with Article 5.2 of the 
SPS Agreement .  Accordingly, the Panel Report in Canada – Continued Suspension does not address the 
consistency of Directive 2003/74/EC with this provision.   WT/DS321/AB/R 
Page 210  
 
'objective assessment of the facts'".
1026  According to the Panel, this corresponds to a duty to "consider 
the evidence presented to us and to make fact ual findings on the basis of that evidence".1027  However, 
the Panel retained the discretion to "decide whic h evidence [it chose] to utilise in making findings"1028 
and to decide "which [experts'] statements [were] us eful to refer to explicitly as long as [it did] not 
deliberately disregard or distort evidence."1029   
500. The Panel recalled that it had consulted six scien tific experts individually, "in order to obtain 
a more complete picture both of mainstream scientific opinion and of any divergent views."1030  The 
Panel explained that, while it ge nerally followed the opinion of a majority of experts that had 
expressed concurrent views on the scientific ques tions before it, sometimes divergences of views 
rendered this approach impracticable.  In these ci rcumstances, the Panel accepted the position(s) that 
it considered most specific to the question at issue,  or best supported by arguments and evidence.  The 
experts were also made aware of their role—which was, inter alia , to present scientific issues to the 
members of the Panel in a way that could be unders tood by them—and of the role of the Panel in the 
WTO dispute settlement system—which includes being the trier of facts.  In assessing the scientific 
advice received from the experts, the Panel said it fu lly took into account the co mments of the parties, 
when appropriate.  The Panel also recalled th e approach followed by the Appellate Body in Japan – 
Apples , which required it to address the compatibility of  Directive 2003/74/EC with respect to each of 
the six hormones covered by the measure.  Nevert heless, where the evidence was similar for all 
hormones, or where information was not provided in relation to each hormone, the Panel addressed 
the hormones collectively.1031 
                                                      
1026Panel Report, US – Continued Suspension , para. 7.414;  Panel Report, Canada  – Continued 
Suspension , para. 7.405 (quoting Appellate Body Report, EC – Hormones , para. 117).  
1027Panel Report, US – Continued Suspension , para. 7.416;  Panel Report, Canada  – Continued 
Suspension , para. 7.407.  
1028Ibid. (referring to Appellate Body Report, EC – Hormones , para. 135).  
1029Ibid. (referring to Appellate Body Report, EC – Hormones , para. 138).  
1030Panel Report, US – Continued Suspension , para. 7.418;  Panel Report, Canada  – Continued 
Suspension , para. 7.409.  The Panel noted that, in some circumstances, only one or two experts have expressed 
their views on an issue.  Sometimes these views were similar or complemented each other.  (Panel Report, US – 
Continued Suspension , para. 7.420;  Panel Report, Canada  – Continued Suspension , para. 7.411)  In other 
circumstances, a larger number of experts expressed opinions and, sometimes, they expressed diverging opinions. 
 
1031Panel Report, US – Continued Suspension , paras. 7.420-7.422;  Panel Report, Canada  – Continued 
Suspension , paras. 7.411-7.413.    WT/DS321/AB/R 
 Page 211 
 
 
501. Next, the Panel found that Directive 2003/74/EC is an SPS measure within the meaning of 
paragraph 1 of Annex A to the  SPS Agreement , and particularly item (b).1032  The Panel then sought 
to determine whether the permanent ban on meat and meat products treated with oestradiol-17 β for 
growth-promoting purposes provided by Directive 2003/74/EC was based on a risk assessment within 
the meaning of Articles 5.1 of the  SPS Agreement .  The European Communities argued that the three 
Opinions issued by the SCVPH, supported by the 17 studies conducted between 1998-2001, 
constituted a risk assessment within  the meaning of Article 5.1, and that the permanent ban on meat 
and meat products from cattle treated with oestradiol-17 β was "based on" such risk assessment. 
502. At the outset of its analysis, the Panel noted that, in order to determine whether the SCVPH 
Opinions constituted a risk assessment with in the meaning of Article 5.1 of the SPS Agreement , it 
would have to examine whether the SCVPH Opinions:  (1) took into account risk assessment 
techniques of the relevant international organizatio ns;  (2) took into account the factors listed in 
Article 5.2 of the  SPS Agreement1033;  (3) satisfied the definition of "risk assessment" contained in 
Annex A, paragraph 4, of the  SPS Agreement ;  and (4) whether the conclusions in the SCVPH 
Opinions are supported by the scientific evidence evaluated.1034 
503. Relying on the reasoning of the panel in Japan – Apples , the Panel found that Article 5.1 of 
the  SPS Agreement does not require compliance with the risk assessment techniques developed by 
international organizations, insofar as it requires that  such techniques are "taken into account" by the 
risk assessor.  The Panel observed that, although th e SCVPH Opinions did not strictly follow the 
                                                      
1032Panel Report, US – Continued Suspension , para. 7.434;  Panel Report, Canada  – Continued 
Suspension , para. 7.425.  Annex A(1)(b) of the  SPS Agreement   reads: 
1. Sanitary or phytosanitary measure – Any measure applied: 
... 
(b) to protect human or animal life or health within the territory of the 
Member from risks arising from additives, contaminants, toxins or disease-
causing organisms in foods, beverages or feedstuffs[.] ... 
 
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;  quaran tine treatments including relevant 
requirements associated w ith the transport of animal s 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. 
None of the parties has argued that Directive 2003/74/EC is not an SPS measure. 
1033Canada did not allege that Directive 2003/74/EC was inconsistent with Article 5.2 of the SPS 
Agreement , and therefore this element was only examined in the case involving the United States. (See supra , 
footnote 1025) 
1034Panel Report, US – Continued Suspension , para. 7.445;  Panel Report, Canada  – Continued 
Suspension , para. 7.434. WT/DS321/AB/R 
Page 212  
 
CODEX and JECFA risk assessment guidelines, th e European Communities "was aware of" and 
"considered" such guidelines when preparing the SCVP H Opinions, and therefore had taken them into 
account within the meaning of Article 5.1.
1035  
504. The Panel in the case involving the United St ates also examined whether the SCVPH 
Opinions took into account the factors listed in Article 5.2.1036  The Panel noted that the United States 
alleged that the European Communities had failed to  take into account two of the specific elements 
listed in Article 5.2, namely:  (i) the available scienti fic information;  and (ii) the relevant inspection, 
sampling, and testing methods.1037  In relation to the first elemen t, the Panel concluded that the 
SCVPH Opinions had specifically addressed eviden ce available with respect to bioavailability, 
susceptibility of sensitive populations, and DNA adduc ts and DNA damages, and took into account 
the very scientific studies that the Unite d States alleged were not considered.1038  R e g a r d i n g  t h e  
second element, the Panel found that the Euro pean Communities had compiled a "Working 
Document"1039 recording visits to United States' regulat ory agencies, on-site inspections, and data 
concerning failures in the United States' inspection regime.  The Panel also observed that a lengthy 
section of the 1999 Opinion is dedicated to discussing the relevant inspection, sampling, and testing 
methods.  For these reasons, the Panel concluded that the European Communities had taken into 
account both the available scientific information a nd the relevant inspection, sampling and testing 
methods in preparing the SCVPH Opinions, as required by Article 5.2 of the  SPS Agreement .1040  
505. Next, the Panel examined whether the SCVPH Opinions satisfied the definition of "risk 
assessment" contained in paragraph 4 of Annex A of the  SPS Agreement .1041  Recalling the Appellate 
Body's jurisprudence from EC – Hormones  and Australia – Salmon , the Panel stated that the 
definition of a risk assessment in paragraph 4 of  Annex A required WTO Members to:  (a) identify the 
additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs;  
(b) identify any possible adverse effect on human or animal health;  and (c) evaluate the potential for 
that adverse effect to arise from the presence of the identified additives, contaminants, toxins or 
disease-causing organisms in food, beverages or feedstuffs.1042 
                                                      
1035Panel Report, US – Continued Suspension , para. 7.469;  Panel Report, Canada  – Continued 
Suspension , para. 7.459.  
1036This section does not appear in the Panel Report in the case against Canada because Canada did not 
raise Article 5.2. (See supra , footnote 1025)   
1037Panel Report, US – Continued Suspension , para. 7.479. 
1038Ibid., para. 7.482. 
1039Ibid., para. 7.483.  
1040Ibid., paras. 7.483 and 7.484. 
1041See infra , para. 525. 
1042Panel Report, US – Continued Suspension , para. 7.507;  Panel Report, Canada  – Continued 
Suspension , para. 7.479.   WT/DS321/AB/R 
 Page 213 
 
 
506. The Panel found that the SCVPH Opinions satisfied the first and second requirements of the 
definition of risk assessment because they sufficiently identified both the contaminant 
(oestradiol-17 β) and the food (meat and meat products) at issue, as well as the possible adverse effects 
on human or animal health (neurobiological, devel opmental, reproductive, a nd immunological effects;  
and immunotoxicity, genotoxicity and carcinogenicity).1043  However, the Panel found that the 
European Communities failed to eval uate specifically the third requirement, that is, the possibility that 
the identified adverse effects "came in to being, originated, or resulted"1044 from the presence of 
residues of oestradiol-17 β in meat or meat products as a result of the administration of that hormone 
to cattle for growth-promoting purposes.  The Pa nel gave the following reasons for its decision. 
507. First, the Panel rejected the European Commun ities' argument that the definition of "risk 
assessment" in Article 5 and Annex A of the  SPS Agreement  also included a "risk management" 
component, in which the WTO Member concerned "weigh[ed] policy alternatives in the light of the 
results of the risk assessment and, if required, select[ed] and implement[ed] appropriate control 
options, including regulatory measures."1045  The Panel took note of the Appellate Body's finding that 
a risk assessment can take into account "matters not susceptible of quanti tative analysis by the 
empirical or experimental laboratory methods commonly associated with the physical sciences".1046  
After discussing the Appellate Body's decision in  EC – Hormones , the Panel reasoned that there is no 
textual basis in the  SPS Agreement  to support the inclusion of a "risk management" component in the 
definition of risk assessment.1047   
508. Secondly, the Panel "asked the experts whether the [SCVPH]  Opinions identified the 
potential for adverse effects on human health, includi ng the carcinogenic or genotoxic potential, of the 
residues of oestradiol-17 β found in meat derived from cattle to which this hormone had been 
administered for growth promotion purposes in acco rdance with good veterinary practice and to what 
extent the Opinions evaluated the poten tial occurrence of these adverse effects."1048  The Panel 
observed, in this regard, that four of the expert s concurred that the scien tific evidence adduced in 
                                                      
1043Panel Report, US – Continued Suspension , para. 7.508;  Panel Report, Canada  – Continued 
Suspension , para. 7.480. 
1044Panel Report, US – Continued Suspension , para. 7.513;  Panel Report, Canada  – Continued 
Suspension , para. 7.485.  
1045Panel Report, US – Continued Suspension , para. 7.517;  Panel Report, Canada  – Continued 
Suspension , para. 7.489. (footnote omitted) 
1046Panel Report, US – Continued Suspension , para. 7.520;  Panel Report, Canada  – Continued 
Suspension , para. 7.492 (referring to Appellate Body Report, EC – Hormones , para. 187). 
1047Panel Report, US – Continued Suspension , paras. 7.519 and 7.520;  Panel Report, Canada  – 
Continued Suspension , paras. 7.491 and 7.492 (referring to Appellate Body Report, EC – Hormones , paras. 181 
and 187). 
1048Panel Report, US – Continued Suspension , para. 7.521;  Panel Report, Canada  – Continued 
Suspension , para. 7.493 (referring to replies to Questions po sed by the Panel to the scientific experts, Panel 
Reports, Annex D, para. 180). WT/DS321/AB/R 
Page 214  
 
relation to the possibility that carcinogenic or ge notoxic effects would result from consumption of 
meat treated with oestradiol-17 β was either missing or insufficient.
1049  To the extent that the 
European Communities argued that the relevant risk  from hormones is an "additive risk", the experts 
concluded that the European Communities did not assess the extent to which residues of hormones in 
meat and meat products as a result of the cattle be ing treated with the hormones for growth-promoting 
purposes contribute to additive risks arising from the cumulative exposures of humans to multiple 
hazards, in addition to the endoge nous production of some of these hormones by animals and human 
beings.1050  The Panel then itself "looked at the Opini ons and found statements that indicate that 
specific studies on the potential for the adverse health  effects identified by the European Communities 
to arise from consumption of meat and meat products from cattle treated with oestradiol-17 β for 
growth promotion purposes were not conducted."1051 
509. The Panel concluded: 
All of the statements of the experts, and indeed statements from the 
Opinions, indicate that the Europ ean Communities has evaluated the 
potential for the identified adverse effects to be associated with 
oestrogens in general, but has not provided analysis of the potential 
for these effects to arise from consumption of meat and meat products which contain residues of oestradiol-17 β as a result of the 
cattle they are derived from being treated with the hormone for growth promotion purposes.  The Panel, therefore, concludes that 
although the European Communiti es has evaluated the association 
between excess hormones and neurobiological, developmental, reproductive and immunological effects, as well as immunotoxicity, genotoxicity, and carcinogenicity, it has not satisfied the requirements of the definition of a risk assessment contained in Annex A(4) because it has not evaluated specifically the possibility 
that these adverse effects come into  being, originate, or result from 
the consumption of meat or meat products which contain veterinary 
residues of oestradiol-17 β as a result of the cattle being treated with 
the hormone for growth promotion purposes.
1052 
                                                      
1049Panel Report, US – Continued Suspension , paras. 7.522-7.525;  Panel Report, Canada  – Continued 
Suspension , paras. 7.494-7.497 (referring to replies of Drs. Boobis, Guttenplan, Boisseau, and Cogliano to 
Questions posed by the Panel to the scientific experts, Panel Reports, Annex D, paras. 144, 145, 132, and 180, respectively). 
1050Panel Report, US – Continued Suspension , para. 7.529;  Panel Report, Canada  – Continued 
Suspension , para. 7.501 (referring to replies to Question 56 po sed by the Panel to the scientific experts, Panel 
Reports, Annex D, paras. 422-431). 
1051Panel Report, US – Continued Suspension , para. 7.531;  Panel Report, Canada  – Continued 
Suspension , para. 7.503.  The Panel noted that the 1999 Opinio n looked at three main areas of potential adverse 
effects:  developmental effects on different stages of life;  the relationship between oestrogens and cancer;  and 
the effect of sex hormones on the immune system.  (Panel Report, US – Continued Suspension , para. 7.532;  
Panel Report, Canada  – Continued Suspension , para. 7.504) 
1052Panel Report, US – Continued Suspension , para. 7.537;  Panel Report, Canada  – Continued 
Suspension , para. 7.509.  WT/DS321/AB/R 
 Page 215 
 
 
510. Despite its finding, the Panel proceeded to examin e the fourth element of the test that it had 
set out to determine whether the SCVPH met the defi nition of "risk assessment", that is, whether the 
conclusions of the SCVPH Opinions were sufficientl y supported by the scientific evidence evaluated.  
On the basis of the opinions of the experts consu lted and its own review of the SCVPH Opinions, the 
Panel found that the scientific evidence referred  to in the SCVPH Opinions did not support the 
conclusion that the genotoxicity of oestradiol-17 β has been demonstrated and that residues of 
oestradiol-17 β in meat and meat products lead to increas ed risk of cancer or adverse immunological 
and developmental effects.1053  
511. Accordingly, the Panel concluded that the "[SCVPH] Opinions do not constitute a risk 
assessment because the Opin ions do not satisfy the definition of  a risk assessment contained in 
Annex A(4) second sentence and because the scientific evidence referred to in the Opinions does not 
support the conclusions therein".1054  As a consequence of this finding, the Panel also found that the 
permanent ban on meat and meat products treated with oestradiol-17 β for growth-promoting purposes 
is not a measure "based on" a risk assessment within the meaning of Article 5.1 of the  SPS 
Agreement .1055  Therefore, the Panel concluded that "the [European Communities'] implementing 
measure on oestradiol-17 β is not compatible with Article 5.1 of the  SPS Agreement ."1056 
D. Claims and Arguments on Appeal 
512. The European Communities challenges on appeal  several aspects of the Panel's assessment of 
Directive 2003/74/EC under Article 5.1 of the  SPS Agreement .  First, the European Communities 
argues that the Panel erred in its interpretation of Article 5.1, as informed by Article 5.2, of the  SPS 
Agreement , by excluding from the scope of its analysis arguments and evidence concerning the 
abusive use and difficulties of control in the ad ministration of hormones to cattle for growth 
promotion.1057  Secondly, the European Communities submits that the Panel erred in finding that the 
European Communities failed to ev aluate specifically the risks arising from residues of oestradiol-17 β 
in bovine meat treated with this hormone for growth-promoting purposes.1058  Thirdly, the European 
Communities alleges that the Panel erred in inte rpreting the definition of a risk assessment in 
                                                      
1053Panel Report, US – Continued Suspension , para. 7.572;  Panel Report, Canada  – Continued 
Suspension , para. 7.540. 
1054Panel Report, US – Continued Suspension , para. 7.578;  Panel Report, Canada  – Continued 
Suspension , para. 7.548. 
1055Ibid. 
1056Panel Report, US – Continued Suspension , para. 7.579;  Panel Report, Canada  – Continued 
Suspension , para. 7.549. 
1057European Communities' appellant's submission, paras. 331 and 332.   
1058Ibid., para. 343.  WT/DS321/AB/R 
Page 216  
 
paragraph 4 of Annex A of the  SPS Agreement  as requiring the quantification of the risks arising 
from the consumption of residues of oestradiol-17 β in bovine meat.
1059  
513. The European Communities also argues that the Panel erroneously allocated the burden of 
proof under Article 5.1 of the  SPS Agreement , when it "shift[ed] the burden of proof to the European 
Communities without first examining, provision by provision under the  SPS Agreement  as required 
by the Appellate Body, whether the arguments of the United States and Canada had sufficient merits 
to shift the burden of proof back to the European Communities."1060   
514. Finally, the European Communities charges th e Panel with failing to conduct an objective 
assessment of the facts of the case, as required by Ar ticle 11 of the DSU, in reaching its finding under 
Article 5.1 of the  SPS Agreement .  According to the European Communities, the Panel applied an 
improper standard of review to the evidence before it, by seeking to determine "the correct scientific 
conclusions"1061 as to the risks arising from the hormones at issue, even though Members are entitled 
to rely on divergent opinions co ming from qualified and respected sources.  Instead, the appropriate 
standard of review required th e Panel to determine whether there was any "reasonable scientific 
basis"1062 for the European Communities' measure, whil e respecting the "important and autonomous" 
right of Members to set their level of SPS protection.1063  The European Communities submits that a 
panel should not substitute its scientific judgement for that of the Member taking the measure and 
should recognize the significance of "genuine and legitimate scientific controversy".1064  The 
European Communities challenges the Panel's examination of three distinct aspects of the European 
Communities' risk assessment of oestradiol-17 β:  (i) the risks arising from exposure to hormones from 
multiple endogenous and exogenous sources1065;  (ii) actual or potential genotoxicity of 
oestradiol-17 β1066;  and (iii) specificity or direct causality in the demonstration of risks arising from 
the consumption of bovine meat containing residues of oestradiol-17 β as a result of cattle being 
treated with this substance for growth promotion.1067 
515. The United States considers that the Panel did not err in finding that the European 
Communities' permanent ban on oestradiol-17 β was not based on a risk assessment within the 
meaning of Article 5.1 of the  SPS Agreement .  According to the United States, the Panel did not
                                                      
1059European Communities' appellant's submission, para. 355.  
1060Ibid., para. 294.  
1061Ibid., para. 240. 
1062Ibid., para. 243.  
1063Ibid., para. 222 (quoting Appellate Body Report, EC – Hormones , para. 172). (emphasis omitted) 
1064Ibid., para. 248.  
1065Ibid., para. 249.  
1066Ibid., paras. 250-258.  
1067Ibid., paras. 259-270.   WT/DS321/AB/R 
 Page 217 
 
 
misinterpret Article 5.1 by excluding from its anal ysis evidence regarding misuse or abuse in the 
administration of oestradiol-17 β.  Rather, the Panel "fully appreciated"1068 the significance of the 
European Communities' assertion that misuse or abuse in the administration of oestradiol-17 β could 
add to the particular risk identified, but correctly he ld that those risks would only be relevant had the 
European Communities succeeded in demonstrating that a specific risk arose from residues of 
oestradiol-17 β in meat.  With respect to the European Co mmunities' allegation that the Panel erred in 
finding that it had failed to evaluate specifically th e particular risks at issue, the United States 
maintains that the Panel's specificity re quirement is based on a "careful tracing"1069 of the Appellate 
Body's jurisprudence on Article 5.1, and that the evidentiary record before the Panel supported its 
conclusion that the European Communities "identifie d only 'general risks' and failed to address the 
specific risk required by the  SPS Agreement ."1070  The United States argues that "one expert's 
statement, divorced from the rest  of the evidentiary record"1071 is not sufficient to demonstrate that the 
European Communities evaluated the specific risk at  issue.  The United States also dismisses the 
European Communities' allegation that the Panel re quired the quantification of risks, because the 
Panel did not preclude a qualitative de monstration of risks.  The Panel's reference to the potential 
occurrence of adverse effects focused instead on "whether the [European Communities'] purported 
risk assessment appeared to be 'su fficiently specific to the case at hand.'"1072   
516. Furthermore, the United States maintains that th e Panel did not err in its allocation of the 
burden of proof under Article 5.1.  The Panel was correct in allocating the initial burden of proving 
consistency with Article 5.1 to the European Co mmunities, because its claim under Article 22.8 of the 
DSU was premised on an allegation of consistency of Directive 2003/74/EC.  Having found that the 
European Communities had met this burden, the Pa nel shifted the burden of proof to the United 
States, and correctly found that the United States had rebutted the European Communities' allegation 
of consistency "by submitting positive eviden ce that demonstrated a breach of the  SPS Agreement  by 
the [European Communities]."1073  As a result, the burden of proof "shifted back and forth between the 
parties"1074 and the Panel rightly "followed the practice of other panels to weigh all the evidence 
before it."1075 
517. Finally, the United States rejects the European  Communities' contention that the Panel failed 
to conduct an objective assessment of the matter in its appreciation of the evidence.  The United 
                                                      
1068United States' appellee's submission, para. 54.  
1069Ibid., para. 57.  
1070Ibid., para. 61.  
1071Ibid., para. 60. 
1072Ibid., para. 64 (quoting Appellate Body Report, EC – Hormones , para. 200).  
1073Ibid., para. 93.  
1074Ibid., para. 94.  
1075Ibid. (quoting Panel Report, US – Continued Suspension , para. 7.386).   WT/DS321/AB/R 
Page 218  
 
States submits that the more deferential "reasona bleness" standard articulated by the European 
Communities for disputes under Article 5.1 has b een rejected by the Appellate Body in  EC – 
Hormones  because it finds no support in the text of the  SPS Agreement and "conflates the concept of 
'standard of review' and the a pplication of law to facts."
1076  Under the "objective assessment of the 
facts" standard that applies to disputes under the  SPS Agreement , panels retain a margin of discretion 
as the triers of facts, and may properly "determi ne that certain elements of evidence should be 
accorded more weight than other elements."1077  For the United States, the Panel's exercise of 
judgement in evaluating the evidence was "part and parcel"1078 of its duty to make an objective 
assessment of the facts.  Therefore, the Panel's fi ndings in relation to the risks arising from exposure 
to hormone residues from multiple sources, the actual or potential genotoxicity of oestradiol-17 β, the 
specificity of the risk assessment, and the relevance of misuse and abuse in a risk assessment, were all 
within the bounds of the Panel's discretion as the trier of facts. 
518. Canada submits that the Panel did not err in its  interpretation of Article 5.1, as informed by 
Article 5.2, of the  SPS Agreement .  Canada argues that the Panel did not ignore evidence related to 
misuse and abuse in the administration of hormones in its analysis, but rather correctly considered that 
such evidence was not "material"1079 to its analysis, having found earlier that the European 
Communities had failed to demonstrate specifically th e possibility of adverse effects arising from the 
consumption of bovine meat containing residues of oestradiol-17 β.  Canada additionally asserts that 
the Panel correctly held that the European Commun ities' risk assessment was not sufficiently specific 
to the particular risks at issue.  The Europ ean Communities' assertion that the genotoxicity of 
oestradiol-17 β did not make it possible to perform a quan titative risk assessment is unsubstantiated by 
the evidence, because "the fact that a hormone may be an  in vitro  genotoxin does not mean that it is 
an in vivo  genotoxin."1080  Canada considers that the Panel had a "solid basis" for finding that the risk 
assessment was not sufficiently specific to the risk, because the scientific experts assisting the Panel 
"indicat[ed] very clearly that the [European Communities] did not have scientific evidence to support 
the assertion of the specific risk."1081  Canada also rejects the European Communities' allegation that 
the Panel erred in requiring a quantitative analysis of risk.  According to Canada, the evidence upon 
which the European Communities' risk assessment relies does not contain either a qualitative or a 
quantitative analysis of risk, because the Eu ropean Communities has offered no evidence 
demonstrating the genotoxicity of oestradiol-17 β  in vivo .   
                                                      
1076United States' appellee's submission, para. 39.  
1077Ibid., para. 42 (quoting Appellate Body Report, Japan – Apples , para. 221).  
1078Ibid., para. 47.  
1079Canada's appellee's submission, para. 88.  
1080Ibid., para. 95.  
1081Ibid., para. 99.   WT/DS321/AB/R 
 Page 219 
 
 
519. Canada contends, moreover, that the Panel di d not fail to conduct an objective assessment of 
the matter in reaching its finding under Article 5.1 of the  SPS Agreement .  As the trier of facts, the 
Panel retained the discretion "to give greater weight  to advice of certain experts over that of others" 
and was not required to "treat all advice r eceived from the experts on an equal footing."1082  Canada 
submits that the European Communities has failed to  demonstrate that the Panel exceeded the bounds 
of its discretion in its analysis of the evidence on multiple exposure, genotoxicity, and specificity or 
direct causality. 
520. Australia agrees with the Eur opean Communities' argument that the Panel erred in the 
standard of review that it applied in  its assessment under Article 5.1 of the  SPS Agreement .  Australia 
submits that the standard of review applicab le under Article 5.1 required the Panel to accord 
"considerable deference (but not total deference)"1083 to a Member's risk assessment, and therefore the 
Panel should have focused on "whether the European  Communities' risk asse ssment represented an 
objective and credible view"1084 from a qualified and respected source.  
521. New Zealand disagrees with the European Communities' claims that the Panel erred in its 
assessment of Directive 2003/74/EC under Article 5.1 of the  SPS Agreement.   In New Zealand's 
view, the Panel's conclusion that the permanent ban on oestradiol-17 β provided in 
Directive 2003/74/EC was not based on a risk asse ssment under Article 5.1 was supported by an 
exhaustive review of all the scientific evidence, drawing upon the expertise and knowledge of a group 
of eminent scientific and technical experts.1085 
E. The Panel's Assessment of Directive 2003/74/EC under Article 5.1 of the  SPS 
Agreement 
1. General Disciplines Applicable to the Adoption of an SPS Measure  
522. The  SPS Agreement  recognizes the right of WTO Member s to take measures necessary to 
protect human, animal or plant life or health.  The right to take a protective measure must be exercised consistently with a series of obligations that are set  forth in that Agreement,  and that seek to ensure 
that such measures are properly justified.
1086   
                                                      
1082Canada's appellee's submission, para. 73.  
1083Australia's third participant's submission, para. 36.  
1084Ibid., para. 42.  
1085New Zealand's third participant's submission, para. 3.47. 
1086See the first Recital of the Preamble of the  SPS Agreement .  Article 2.3 of the  SPS Agreement  also 
provides that "Members shall ensure that their sanita ry and phytosanitary measures do not arbitrarily or 
unjustifiably discriminate between Members where identi cal or similar conditions prevail, including between 
their own territory and that of other Members" and that SPS measures "shall not be applied in a manner which 
would constitute a disguised restri ction on international trade." WT/DS321/AB/R 
Page 220  
 
523. There are several concepts that are defined in the   SPS Agreement  and that describe aspects 
of a WTO Member's decision-making process when taking an SPS measure.  The "appropriate level 
of protection" is defined in paragraph 5 of Annex A to the  SPS Agreemen t  as "[t]he level of 
protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health w ithin its territory."  It is the "prerogative"
1087 of a WTO 
Member to determine the level of protection that it deems appropriate.1088  The SPS measure is the 
"instrument" chosen by the WTO Member to impl ement its sanitary or phytosanitary objective.1089  
Based on the wording of Article 5.6 of the  SPS Agreement , the Appellate Body has explained that the 
"determination of the level of protection is an el ement in the decision-making process which logically 
precedes and is separate from the establishm ent or maintenance of the SPS measure".1090  I n  o t h e r  
words, the appropriate level of protection determines the SPS measure to be introduced or maintained, 
rather than the appropriate level of prot ection being determined by the SPS measure.1091  T h e  
Appellate Body has also found that "the  SPS Agreement  contains an implicit obligation to determine 
the appropriate level of protection."1092  Although it need not be determ ined in quantitative terms, the 
level of protection cannot be determined "with such  vagueness or equivocation that the application of 
the relevant provisions of the  SPS Agreement  ... becomes impossible".1093 
524. Another important aspect of the decision-maki ng process is the "risk assessment".  Pursuant 
to Article 5.1 of the  SPS Agreement , an SPS measure must be "based on an assessment, as 
appropriate to the circumstances, of the risks to human, animal or plant life or health".  Under 
Article 5.7 of the  SPS Agreement , WTO Members are also allowed to take an SPS measure, on a 
provisional basis, where certain conditions are fulf illed, including where the relevant scientific 
evidence is insufficient to perform  a risk assessment.  We examine Article 5.7 in more detail in 
section VII.   
                                                      
1087Appellate Body Report, Australia – Salmon , para. 199. (emphasis omitted) 
1088Although it is for a WTO Member to choose its level of protection, the   SPS Agreement  provides 
for disciplines that a Member must respect when it has done so.  Pursuant to Article 5.5, a WTO Member "shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if 
such distinctions result in discrimination or a disguised rest riction on international trade."  Article 5.6 states that 
Members "shall ensure that [SPS] m easures are not more trade-restric tive than required to achieve their 
appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility".  
In addition, Article 5.4 provides that "Members should, when determining the appropriate level of sanitary or 
phytosanitary protection, take into account the objective of minimizing negative trade effects." 
1089Appellate Body Report, Australia – Salmon , para. 200. (emphasis omitted) 
1090Ibid., para. 203. (emphasis omitted) 
1091Ibid., para. 206. 
1092Ibid. 
1093Ibid., para. 203.  WT/DS321/AB/R 
 Page 221 
 
 
525. A "risk assessment" is defined in paragraph 4 of Annex A to the  SPS Agreement  as: 
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. 
526. Article 5.1 is a "specific application of the b asic obligations contained in Article 2.2 of the 
SPS Agreement ."
1094  Article 2.2 focuses on the need for an  SPS measure to be based on scientific 
principles and sufficient scientific evidence.  It provides: 
Members shall ensure that any sanita ry or phytosanitary measure is 
applied only to the extent necessary to protect human, animal or plant 
life or health, is based on scientific  principles and is not maintained 
without sufficient scientific evid ence, except as provided for in 
paragraph 7 of Article 5.  
The Appellate Body has observed that "Articles 2. 2 and 5.1 should constantly be read together" 
because "Article 2.2 informs Articles 5.1: the elemen ts that define the basi c obligation set out in 
Article 2.2 impart mean ing to Article 5.1."1095   
527. A list of factors that must be taken into account in a risk assessment is provided in Article 5.2.  
The list begins with "available scientific evid ence" and also includes:  "relevant processes and 
production methods;  relevant inspection, sampli ng and testing methods;  prevalence of specific 
diseases or pests; existence of pest- or disease-fr ee areas; relevant ecological and environmental 
conditions; and quarantine or other treatment."  In  EC – Hormones , the panel described a "risk 
assessment" as a "scientific pro cess aimed at establishing the scientific basis" for the SPS measure.1096  
The Appellate Body understood the panel to refer to "a process characterized by systematic, disciplined and objective enquiry and analysis, that is, a mode of studying and sorting out facts and opinions".
1097  Science therefore plays a central role in a risk assessment.  However, the Appellate 
Body has cautioned against taking too narro w an approach to a risk assessment: 
It is essential to bear in mind that th e risk that is to be evaluated in a 
risk assessment under Article 5.1 is not only risk ascertainable in a 
science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the 
                                                     
 
1094Appellate Body Report, EC – Hormones , para. 180.  
1095Ibid. 
1096Ibid., para. 187 (quoting Panel Report, EC – Hormones (US) , para. 8.107;  and Panel Report, EC – 
Hormones (Canada) , para. 8.110). 
1097Ibid., para. 187. WT/DS321/AB/R 
Page 222  
 
actual potential for adverse effects on human health in the real world where people live and work and die.
1098 
528. As we noted earlier, Article 5.1 requires that SPS measures be "based on" a risk assessment.  
This does not mean that the SPS measures have to "conform to" the risk assessment.  Instead, "the 
results of the risk assessment must sufficiently  warrant—that is to say, reasonably support—the SPS 
measure at stake".1099  Put differently, there must be a "rational relationship" between the SPS 
measure and the risk assessment.1100 
529. Moreover, the risk assessment need not  "come to  a monolithic conclusion that coincides with 
the scientific conclusion or view implicit in the SPS measure", nor does the risk assessment have to 
"embody only the view of a majority of the relevant scientific community."1101  While recognizing 
that, in most cases, WTO Members "tend to base their legislative and administrative measures on 
'mainstream' scientific opinion", the Appellate Body  has observed that, "[i]n other cases, equally 
responsible and representative governments may act in good faith on the basis of what, at a given 
time, may be a divergent opinion comi ng from qualified and respected sources."1102  The Appellate 
Body added that an approach based on a diverg ent opinion from a qualified and respected source, 
"does not necessarily signal the absence of a reasona ble relationship between the SPS measure and the 
risk assessment, especially wh ere the risk involved is life-threatening in character and is perceived to 
constitute a clear and imminent thr eat to public health and safety."1103  
530. An SPS measure need not be based on a risk  assessment performed by the WTO Member 
taking the measure.  It can be based on a risk assessment performed by a relevant international 
organization or by another WTO Member.1104  The risk assessment can be  quantitative or qualitative 
in nature.1105  Nevertheless, the Appellate Body h as noted that "theoretical uncertainty"1106 is not the 
kind of risk to be assessed under Article 5.1;  instead, the risk to be assessed must be an 
"ascertainable" risk.1107  In addition, the risk assessment must ha ve the requisite degree of specificity.  
The assessment must be "sufficiently specific"1108 in terms of the harm concerned and the precise 
agent that may possibly cause the harm.1109   
                                                      
1098Appellate Body Report, EC – Hormones , para. 187. 
1099Ibid., para. 193. 
1100Ibid. 
1101Ibid., para. 194. 
1102Ibid. 
1103Ibid. 
1104Ibid., para. 190. 
1105Ibid., para. 186.  
1106Ibid. 
1107Ibid. 
1108Ibid., para. 200. 
1109Appellate Body Report, Japan – Apples , para. 202.  WT/DS321/AB/R 
 Page 223 
 
 
531. Whilst WTO Members have the right to take SPS me asures, they are not required to do so.  
The risk assessment may conclude that there is  no ascertainable risk, in which case no SPS measure 
can be taken.  Alternatively, a WTO Member may conclude that an SPS measure is not necessary in 
the light of the risks determined in the risk assessment and the acceptable level of protection 
determined by that WTO Member.   
532. International standards are given a prominent role under the  SPS Agreement , particularly in 
furthering the objective of promoting the harmoni zation of sanitary and phytosanitary standards 
between WTO Members.1110  This is to be achieved by encouraging WTO Members to base their SPS 
measures on international standards, guide lines or recommendations, where they exist.1111  There is a 
rebuttable presumption that SPS measures that conf orm to international standards, guidelines or 
recommendations are "necessary to protect human, an imal or plant life or health, and ... [are] 
consistent with the relevant provision s of this Agreement and of GATT 1994".1112  While use of 
international standards is encouraged, the  SPS Agreement  recognizes the right of WTO Members to 
introduce or maintain an SPS measure  which results in a higher leve l of protection than would be 
achieved by measures based on such international st andards.  Where a Member exercises its right to 
adopt an SPS measure that results in a higher level of protection, that right is qualified in that the SPS 
measure must comply with the other requirements of the  SPS Agreement1113, including the 
requirement to perform a risk assessment.1114  However, the Appellate Body has found that the 
adoption of an SPS measure that does not conform to an international standard and results in a higher 
level of protection does not give rise to a more exacting burden of proof under the  SPS Agreement :   
The presumption of consistency w ith relevant provisions of the SPS 
Agreement  that arises under Article 3.2 in respect of measures that 
conform to international standards may well be an incentive  for 
Members so to conform their SPS measures with such standards.  It is clear, however, that a decision of a Member not to conform a particular measure with an intern ational standard does not authorize 
imposition of a special or generalized burden of proof upon that 
Member, which may, more often than not, amount to a  penalty .
1115 
(original emphasis) 
533. At the oral hearing, we explored the relations hip between the appropriate level of protection 
and the risk assessment.  The European Communities c onsiders that the appropriate level of protection 
can clearly be taken into account in  a risk assessment and may, in so me cases, be reflected in the
                                                      
1110See Article 3 and Recital 6 of the Preamble of the  SPS Agreement . 
1111Article 3.1 of the  SPS Agreement . 
1112Article 3.2 of the  SPS Agreement . 
1113Article 3.3 of the  SPS Agreement . 
1114Appellate Body Report, EC – Hormones , paras. 176 and 177. 
1115Ibid., para. 102. WT/DS321/AB/R 
Page 224  
 
mandate and parameters given to the risk assessors.  The United States and Canada recognize that the 
acceptable level of risk may sometimes play a ro le, albeit a limited one, in respect of the risk 
assessment.  The United States and Canada, howev er, caution about the need to maintain the 
objectivity of the risk assessment process and rej ect the notion that subjective policy choices have a 
role to play in a risk assessment.  In their view , these policy choices may be taken into account by a 
WTO Member in determining its appropriate leve l of risk and in selecting the SPS measure, but 
should not be part of the risk assessment process,  which must remain an objective and scientific 
evaluation. 
534. The risk assessment cannot be entirely isolated  from the appropriate level of protection.  
There may be circumstances in which the appropriate level of protection chosen by a Member affects the scope or method of the risk assessment.  This  may be the case where a WTO Member decides not 
to adopt an SPS measure based on an international standard because it seeks to achieve a higher level 
of protection.  In such a situation, the fact that the WTO Member has chosen to set a higher level of 
protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered a nd the research carried out in the risk assessment underlying the 
international standard.  However, the chosen level of protection must not affect the rigour or objective 
nature of the risk assessment, which must remain, in its essence, a process in which possible adverse 
effects are evaluated using scientific methods.
1116  Likewise, whatever the level of protection a 
Member chooses does not pre-determine the results of  the risk assessment.  Otherwise, the purpose of 
performing the risk assessment would be defeated.1117  
535. We understand that Codex draws a distinc tion between "risk assessment" and "risk 
management".1118  It defines "risk management" as "the process, distinct from risk assessment , of 
weighing policy alternatives ... considering risk asses sment and other factors relevant for the health
                                                      
1116We recall, however, that the scien tific process must not be understood narrowly as being confined 
to matters that are "susceptible of quantitative analysis by the empirical or experimental la boratory methods 
commonly associated with the ph ysical sciences."  Instead, the risk to be evaluated also includes the "risk in 
human societies as they actually exist,  in other words, the actual potential for adverse effects on human health in 
the real world where people live and work and die". (Appellate Body Report, EC – Hormones , para. 187)  
1117This is consistent with the Appellate Body's  views about the relationship between the risk 
assessment and the SPS measure: 
We understand this phrase to imply that a risk assessment should not be 
limited to an examination of the measur e 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 
preconceived 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 . 
(Appellate Body Report, Japan – Apples , para. 208) 
1118Codex Alimentarius Commission, Procedural Manual, 15th edition, p. 44.  See also Panel Report, 
US – Continued Suspension , para. 7.515;  and Panel Report, Canada – Continued Suspension , para. 7.487.  WT/DS321/AB/R 
 Page 225 
 
 
protection of consumers and for the promotion of fair trade practices, and, if needed, selecting 
appropriate prevention and control options."1119  In  EC – Hormones , the Appellate Body noted that 
the  SPS Agreement  does not refer to the concept of "risk management" and it rejected the panel's 
restrictive interpretation of a "risk assessment" based on that distinction.1120  The Appellate Body has 
not provided a clear demarcation of the factors th at may be considered in a "risk assessment" under 
the  SPS Agreement , but it has held that the list of factors provided in Article 5.2 is not a closed list 
and, in particular, that abuse or misuse and difficu lties of control in the administration of hormones 
may be considered in the context of a risk assessment.1121  
536. Before we proceed to examine the European  Communities' claims, we briefly summarize 
some of the relevant facts of this case.  We note that Codex has adopted an international standard for 
oestradiol-17 β, based on evaluations carried out by JECFA.1122  The European Communities asserts 
that it has determined a higher le vel of protection than that whic h would be achieved under Codex's 
standard.  According to the European Communities, it s level of protection is "no (avoidable) risk, that 
is a level of protection that does not allow an y unnecessary addition from exposure to genotoxic 
chemical substances that are intended to be added deliberately to food."1123  The European 
Communities also notes that it has performed a ri sk assessment for meat from cattle treated with 
oestradiol-17 β for growth-promotion purposes.  This risk  assessment consists of the 1999, 2000, 
and 2002 Opinions, as supported by 17 studies c onducted between 1998 and 2001.  The European 
Communities further explains that its SPS measure —that is, the import and marketing ban applied 
pursuant to Directive 2003/74/EC—was taken in the light of the higher level of protection that it 
determined for itself and is properly based on its risk assessment.1124   
2. The Panel's Interpretation and Applica tion of Articles 5.1 and 5.2 of the  SPS 
Agreement   
537. We examine, first, the European Communities'  claim that the Panel erred by adopting "an 
extremely narrow and consequently erroneous interpretation of Article  5.1 and failed to take into 
account that risk assessment and risk management partly overlap in the  SPS Agreement ".1125  T h e   
European Communities argues that the Panel's restri ctive interpretation of risk assessment led it to 
                                                      
1119Codex Alimentarius Commission, Procedural Manual, 15th edition, p. 45. (emphasis added) 
1120Appellate Body Report,  EC – Hormones , para. 181. 
1121Ibid., paras. 187 and 206. 
1122See supra , footnote 933. 
1123Panel Report, US – Continued Suspension , para. 7.607;  Panel Report, Canada – Continued 
Suspension , para. 7.585 (referring to replies of the European Communities to questions posed by the Panel after 
the second substantive meeting, Panel Reports, Annex C-1, para. 69).  See also 1999 Opinion, section I.2. 
1124Panel Report, US – Continued Suspension , para. 7.390;  Panel Report, Canada – Continued 
Suspension , para. 7.387.  
1125European Communities' appellant's submission, para. 308. WT/DS321/AB/R 
Page 226  
 
wrongfully exclude from the scope of its analysis under Article 5.1 evidence concerning misuse or 
abuse and difficulties of control in the administra tion of hormones to cattle for growth promotion. 
538. We begin by reviewing the Pa nel's understanding of the Appella te Body's interpretation of 
Article 5.1 in  EC – Hormones  and particularly its discussion of the relevance of risk management 
factors for the purposes of a risk assessment within  the meaning of Annex A and Article 5.1 of the 
SPS Agreement .  The Panel in this case interpre ted the Appellate Body's ruling in  EC – Hormones  as 
follows:  
Although the Appellate Body disappr oved of the original panel's 
distinction between "risk assess ment" and "risk management" 
because it had no textual basis in the Agreement, this Panel can find 
no statement by the Appellate Body confirming that what the European Communities describes as risk management is included within the definition of a risk asse ssment as set forth in Annex A(4) 
of the SPS Agreement .  In fact, the Appellate Body stressed that 
Article 5 and Annex A speak of risk assessment  only and that the 
term risk management  is not to be found either in Article 5 or in any 
other provision of the  SPS Agreement . 
The Panel agrees with the Appellate  Body that its role as a treaty 
interpreter is to "read and interp ret the words actually used by the 
agreement under examination, and not words which the interpreter 
may feel should have been used."  The Panel takes note of the 
Appellate Body's finding that a risk assessment can take into account "matters not susceptible of quantitative analysis by the empirical or experimental laboratory methods commonly associated with the physical sciences."  However, the Pane l finds that neither that finding 
nor the text of the Agreement includ es within the definition of a risk 
assessment the concepts put forward by the European Communities 
as "risk management."
1126  (footnote omitted) 
539. Therefore, the Panel stated that it would ask qu estions of the experts relating to whether the 
SCVPH Opinions identified the potential for adve rse effects on human health of residues of 
oestradiol-17 β in the meat of cattle treated with this hormone when applied in accordance with good 
veterinary practice.1127  
                                                      
1126Panel Report, US – Continued Suspension , paras. 7.519 and 7.520;  Panel Report, Canada – 
Continued Suspension , paras. 7.491 and 7.492.  
1127Panel Report, US – Continued Suspension , para. 7.521;  Panel Report, Canada – Continued 
Suspension , para. 7.493.  WT/DS321/AB/R 
 Page 227 
 
 
540. At the interim review stage, the Eur opean Communities asserted that the Panel 
"misinterpret[ed]" what the Appellate Body had said in  EC – Hormones .1128  In response, the Panel 
explained:  
The Appellate Body disapproved of the panel's use in the original 
EC – Hormones dispute of the distinction between "risk assessment" 
and "risk management" because it ha d no textual basis.  However, 
this did not mean that the Appellate  Body endorsed an interpretation 
of Article 5.1 or Annex A(4) of the  SPS Agreement  that included a 
risk management stage.  In fact, it emphatically stated that the term "risk management" is not to be found in Article 5 or any other 
provision of the  SPS Agreement.  The Panel, therefore, finds no basis 
for the European Communities' ass ertion that the Appellate Body 
"confirmed that a risk assessment within the meaning of Article 5.1 includes a risk management stage which is the responsibility of the 
regulator to carry out and not of the scientific bodies."
1129  (footnote 
omitted) 
541. We find it difficult to reconcile the Panel's understanding of  EC – Hormones  with what the 
Appellate Body held in that Report.  As we noted ab ove, in that case, the Appellate Body rejected the 
rigid distinction drawn by the panel between "ris k assessment" and "risk management", explaining:  
We must stress, in this connection, that Article 5 and Annex A of the 
SPS Agreement  speak of "risk assessment" only and that the term 
"risk management" is not to be f ound either in Article 5 or in any 
other provision of the  SPS Agreement .  Thus, the Panel's distinction, 
                                                      
1128Panel Report, US – Continued Suspension , para. 6.97;  Panel Report, Canada – Continued 
Suspension , para. 6.89. 
1129Panel Report, US – Continued Suspension , para. 6.99;  Panel Report, Canada – Continued 
Suspension , para. 6.91.  The Panel added: 
Nowhere in the texts of Article 5.1 and Annex A(4) does the Panel find 
support for the European Communities' contention that a risk assessment 
within the meaning of the SPS Agreement  includes "weighing policy 
alternatives in light of the results of risk assessment and, if required, 
selecting and implementing appropriate control options, including 
regulatory measures."  What the European Communities seems to be describing is how a government chooses an appropriate SPS measure based 
on a risk assessment.  The Panel does not find that this is contemplated by 
the texts of Article 5.1 and Annex A(4) of the  SPS Agreement . 
(Panel Report, US – Continued Suspension , para. 6.102;  Panel Report, Canada – Continued Suspension , 
para. 6.94. (footnote omitted))  Similarly, the Panel did not address evidence on misuse or abuse in the 
administration of the hormones in its analysis under Article 5.7 of the  SPS Agreement .  The Panel reasoned that: 
 ... Article 5.7 is applicable when re levant scientific evidence is not 
sufficient to undertake a risk assessment in conformity with Article 5.1.  Whether instances of misuse or abuse in the administration of hormones 
exist or not is not as such a scientific issue likely to make a risk assessment 
within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement  
impossible.  
(Panel Report, US – Continued Suspension , para. 7.603;  Panel Report, Canada – Continued Suspension , 
para. 7.578)  WT/DS321/AB/R 
Page 228  
 
which it apparently employs to achie ve or support what appears to be 
a restrictive notion of risk assessment, has no textual basis.
1130 
Subsequently in the same Report, the Appellate Body  reiterated its view that "the concept of 'risk 
management' is not mentioned in any provision of the  SPS Agreement  and, as such, cannot be used 
to sustain a more  restrictive  interpretation of 'risk assessment' than  is justified by the actual terms of 
Article 5.2, Article 8 and Annex C of the  SPS Agreement ".1131   
542. Therefore, in our view, the Panel's interpretation of "risk assessment" resulted in the same 
"restrictive notion of risk assessment"1132 that the Appellate Body found to be erroneous in EC – 
Hormones .  The Panel sought in this case to rewrite the Appellate Body Report in EC – Hormones  
and to re-establish the rigid distinction between "risk assessment" and "risk management" that the 
Appellate Body had rejected in that case. 
543. We set out above our understanding of  the Appellate Body's finding in EC – Hormones  in so 
far as the distinction between "risk assessment" and "r isk management" is concer ned.  We now turn to 
the European Communities' argument that the di stinction that the Panel drew between "risk 
assessment" and "risk management" resulted in the exclusion of certain factors from the Panel's 
analysis under Article 5.1 of the  SPS Agreement .  In particular, the European Communities asserts 
that the Panel improperly excluded the eviden ce concerning misuse or abuse and difficulties of 
control in the administration of hormones to cattle for growth promotion.1133  
544. The relevance of the risks relating to abuse or misuse in the administration of hormones was 
also addressed in  EC – Hormones .  In that case, the Appellate Body noted that "[s]ome of the kinds 
of factors listed in Article 5.2 such as 'relev ant processes and production methods' and 'relevant 
inspection, sampling and testing methods' are not n ecessarily or wholly susceptible of investigation 
according to laboratory methods of, for example, bioc hemistry or pharmacology" and that "there is 
nothing to indicate that the listing of factors that  may be taken into account in a risk assessment of 
Article 5.2 was intended to be a closed list."1134  It then specifically examin ed whether risks relating to 
                                                      
1130Appellate Body Report, EC – Hormones , para. 181. 
1131Ibid., para. 206. (emphasis added)  The Appellate Body considered that the language in Article 5.2 
("relevant processes and production methods;  relevant  inspection, sampling and testing methods"), Article 8, 
and Annex C ("control, inspection and approval procedures") "is amply sufficient to authorize the taking into 
account of risks arising from failure to comply with the requirements of  good veterinary practice in the 
administration of hormones for growth promotion purposes, as well as risks arising from difficulties of control, 
inspection and enforcement of  the requirements of good  veterinary practice." ( Ibid., para. 205) 
1132Ibid., para. 181. 
1133European Communities' appellant's submission, para. 325.  At the oral hearing, the European 
Communities confirmed that its appeal focuses on misuse and abuse in the administration of hormones only, and that it is not claiming that the Panel erroneously excluded other factors on the basis of its general distinction 
between "risk assessment" and "risk management". 
1134Appellate Body Report, EC – Hormones , para. 187.   WT/DS321/AB/R 
 Page 229 
 
 
misuse or abuse in the administration of the hormones could be considered as part of the "risk 
assessment": 
Where the condition of observance of good veterinary practice 
(which is much the same condition attached to the standards, 
guidelines and recommendations of Codex with respect to the use of 
the five hormones for growth promotion) is not followed, the logical 
inference is that the use of such hormones for growth promotion purposes may or may not be "safe".  The SPS Agreement  requires 
assessment of the potential for adverse effects on human health 
arising from the presence of contaminants and toxins in food.  We 
consider that the object and purpose of the SPS Agreement  justify the 
examination and evaluation of all such risks for human health whatever their precise and immediate origin may be.  We do not mean to suggest that risks arising from potential abuse in the 
administration of controlled subs tances and from control problems 
need to be, or should be, evaluated by risk assessors in each and every case.  When and if risks of these types do in fact arise, risk assessors may examine and evaluate them.  Clearly, the necessity or 
propriety of examination and evalua tion of such risks would have to 
be addressed on a case-by-case basis.  What, in our view, is a 
fundamental legal error is to exclude, on an  a priori  basis, any such 
risks from the scope of application of Articles 5.1 and 5.2.  We disagree with the Panel's suggestion that exclusion of risks resulting 
from the combination of potential a buse and difficulties of control is 
justified by distinguishing betw een "risk assessment" and "risk 
management".  As earlier noted, th e concept of "risk management" is 
not mentioned in any provision of the  SPS Agreement  and, as such, 
cannot be used to sustain a more restrictive interpretation of "risk assessment" than is justified by the actual terms of Article 5.2, Article 8 and Annex C of the  SPS Agreement .
1135  (original 
emphasis;  footnote omitted) 
545. Thus, the risks arising from the abuse or mi suse in the administration of hormones can 
properly be considered as part of a risk assessment .  Where a WTO Member has taken such risks into 
account, they must be considered by a panel re viewing that Member's risk assessment.  Any 
suggestion that such risks cannot form part of a risk assessment would constitute legal error. 
546. At the interim review stage, the Panel dismis sed the relevance of the evidence concerning 
misuse or abuse in the administration of hormones under Article 5.1 for the following reasons1136:  
                                                      
1135Appellate Body Report, EC – Hormones , para. 206. 
1136At the interim review stage, the European Commun ities criticized the Panel for referring to misuse 
or abuse only in the analysis of whether the European Communities had taken account of the factors listed under 
Article 5.2, which the Panel examined at the request of the United States.  The European Communities asserted 
"that the Panel's discussion of the potential misuse and abuse in the administration of hormones is in the wrong place, to the extent that this is an aspect of risk assessment, in the sense of Article 5.1 to 5.3 of the 
SPS Agreement , that is applicable across all identified potential risks and for all six hormones."  (Panel Report, 
US – Continued Suspension , para. 6.164;  Panel Report, Canada – Continued Suspension , para. 6.154) WT/DS321/AB/R 
Page 230  
 
The Panel agrees with the Europ ean Communities that the question 
of misuse and abuse in the administration of hormones may apply to all six hormones at issue and is an element that can be taken into account in risk assessment, as set forth in Article 5.2 of the SPS Agreement  and confirmed by the Appellate Body in EC – 
Hormones .  However, the Panel did not deem it necessary to address 
this question in the section regardi ng the conformity with Article 5.1 
of the definitive ban on oestradiol-17 β, to the extent that the question 
whether misuse or abuse exists in the administration of hormones did not have an impact on the issues addressed by the Panel under 
Article 5.1.  Indeed, the question of misuse or abuse in the 
administration of hormones is relevant to the extent that it can lead to 
higher concentrations of hormone residues in meat and meat products than would occur if good veterinary  practices were applied.  As 
stated by the 1999 Opinion, it is an aspect of exposure assessment.  
In this case, the Panel found that the European Communities had not 
evaluated specifically the possibility that the adverse effect[s] that it 
had identified in its risk assessment come into being, originate, or result from the consumption of meat or meat products which contain veterinary residues of oestradiol-17 β as a result of the cattle being 
treated with this hormone for growth promotion purposes.  Therefore, 
whether the concentrations of hor mone residues in meat and meat 
products could be higher as a result of misuse or abuse did not have to be addressed.  The Panel does not deem it necessary to move this section to another part of its findings.
1137 (footnote omitted) 
547. The United States and Canada consider that this  statement indicates that the Panel did address 
the European Communities' arguments relating to misuse or abuse.1138  We note that in this statement, 
the Panel acknowledges that those risks are "an el ement that can be taken into account in risk 
assessment, as set forth in Article 5.2 of the  SPS Agreement  and confirmed by the Appellate Body in 
EC – Hormones ."  Although the Panel does not seem to reject  a priori  the relevance of the potential 
risks of misuse or abuse, it then states that it was not necessary to address this question in its analysis, 
to the extent that it did not have an impact on th e issues addressed by the Panel under Article 5.1.  
However, some of the scientific experts consulte d by the Panel indicated that risks arising from 
residues of oestradiol-17 β in bovine meat are likely to increase where good veterinary practices in the 
administration of this hormone are not followed.  Indeed, these experts agreed that their conclusions 
in relation to the risks posed by oestradiol-17 β were predicated on good veterinary practices being 
followed.  Accordingly, the abuse or misu se in the administration of oestradiol-17 β has a bearing on 
the particular risks being assessed by the European  Communities.  The Panel's conclusion was thus 
premature because the Panel could not have deci ded whether the European Communities failed to 
evaluate specifically the possible adver se effects of residues of oestradiol-17 β in meat before 
                                                      
1137Panel Report, US – Continued Suspension , para. 6.164;  Panel Report, Canada – Continued 
Suspension , para. 6.154. 
1138United States' appellee's submission, para. 54;  and Canada's response to questioning at the oral 
hearing.  WT/DS321/AB/R 
 Page 231 
 
 
considering the evidence on abuse or misuse.  The Pa nel's summary dismissal of the relevance of the 
evidence on misuse or abuse at the interim revi ew stage gives the appearance of being an ex post  
rationalization of an earlier decision to exclude such risks from consideration.  
548. The risks of abuse or misuse of the hormon es at issue were examined by the European 
Communities as part of its risk assessment.  The 1999 Opinion examines the risks arising from 
misplaced implants and the consumption of meat  from implantation sites, off-label use of the 
hormones (such as in animals for which the implant or  feed pre-mix is not approved), possible uses of 
non-authorized pharmaceutical formulations, and secondary risks for residues of other drugs.1139  The 
1999 Opinion concludes:  
it has to be noted that misplaced implants and black market drugs 
comprise the risk that extremely high levels of residues of hormones remain in edible tissues of animals.   In addition, it has to be noted 
that the contemporaneous use of growth promoting hormones and veterinary therapeutics drugs incr eases the prevalence of undesirable 
r[e]sidues in edible tissues of bovines.
1140 
549. The 2002 Opinion also addresses the risks of abuse or misuse.1141  It refers to a study that 
simulated the disregard of good veterinary practi ces and to two studies relating to MGA.  The 2002 
Opinion concludes: 
... these experiments clearly identify a risk for excessive exposure of 
consumers to residues from misplaced or off-label used implants and 
incorrect dose regimes.  In these cases, levels of oestradiol and its 
metabolites in muscle, fat, liver and kidney from hormone treated cattle may be 2-fold up to several hundred folds higher as compared 
to untreated meat.  The level of increase depends on the treatment regime and the actual hormone levels in the implants used.
1142   
550. In its consultations with the scientific experts, the Panel explored the relevance of the failure 
to observe good veterinary practices.  The Pane l asked the experts whether identification of 
oestradiol-17 β as a human carcinogen indicates that ther e are potential adverse effects on human 
health when it is consumed in meat from cattle tr eated with hormones for growth-promotion purposes.  
                                                      
11391999 Opinion, pp. 30-32. 
1140Ibid., p. 32. 
11412002 Opinion, pp. 11 and 12. The 2002 Opinion also concludes that "[MGA] applied in 
concentrations exceeding the licensed dose s by a factor of 3 would result in a violation of the tolerance levels as 
proposed by US-FDA." (2002 Opinion, p. 11)  Similarly, the 2002 Opinion found that "[m]odel calculations 
indicated that, depending on the actual implanted total dos e, processing of such inj ection sites can contaminate 
tons of (minced) meat or meat products with hormone co ncentrations violating the ADI/MRL levels as proposed 
by JECFA and other regulatory bodies." ( Ibid., p. 11) 
1142Ibid., pp. 11 and 12. WT/DS321/AB/R 
Page 232  
 
The experts were also asked whet her their answer would depend on wh ether good veterinary practices 
are followed.
1143  Dr. Guttenplan responded: 
If potential is taken to mean possible, then an adverse effect cannot 
be ruled out, but it is unlikely if good veterinary practices are 
followed.  If good veterinary practices are not followed, the potential 
for adverse effects may be significant.1144 
In response to another question on the subject posed by the Panel, Dr. De Brabander recognized that 
"[i]mproper administration of implants or misplaced implants create potential hazards to human health".
1145 
551. The European Communities also submitted to th e Panel the final reports of two missions 
carried out in the United States and Canada to evaluate their control procedures.1146  The Panel asked 
the scientific experts whether this  evidence "call[ed] into question the potential applicability of Codex 
standards with regard to imports of meat from ca ttle treated with hormones from the United States and 
Canada.1147  Dr. De Brabander agreed th at this evidence was relevant: 
The material put forth by the European Communities regarding 
misuse or abuse of the hormones at issue in the United States and 
Canada calls indeed into question the potential applicability of Codex 
standards with regard to imports of meat from cattle treated with hormones from the United States and Canada.
1148 
                                                      
1143Panel Reports, Annex D, p. D-26, Question 15. 
1144Ibid., para. 155.  Dr. Cogliano disagreed.  In his view, the "answer does not depend on whether 
good veterinary practices are followed.  It depends on the presence of the hormone in the meat that people 
consume". ( Ibid., para. 154) 
1145Ibid., para. 393.  Dr. Boobis also r ecognized the potentia l hazards arising form abuse or misuse, 
although his response was qualified: 
In my view, the potential hazards from the use of large quantities of the six 
hormones in dispute are those dependent on their endocrine activity, 
including cancer in hormonally responsive tissues.  However, I should stress 
that this is their potential hazard.  The potential risk, i.e. the probability that effects would occur, would depend on a number of factors.  These include 
the magnitude of the exposure, the duration of the exposure and the life 
stage of the exposed individual.  From the range of exposures likely from anticipated misuse or abuse the risks are likely to be very low (see 
Question 62). 
(Ibid., para. 392) 
1146See Final Report of a mission carried out in the United States from 19-30 June 2000 in order to 
review the systems in place for approval, control and supe rvision of cold stores and the certification of fresh 
meat and meat products, DG(Sanco)/1176/2000-MR Final, and Final Report of a mission carried out in Canada 
from 19-29 September 2000 in order to evaluate the control of residues in live animals and animal products, 
DG(Sanco)/1188/2000-MR final (Exhibits EC-67 and EC-68 submitted by the European Communities to the Panel). 
1147Panel Reports, Annex D, p. D-83, Question 51. 
1148Ibid., para. 403.  WT/DS321/AB/R 
 Page 233 
 
 
552. As noted earlier, the relevance of abuse or misuse in the administration of the hormones at 
issue was recognized by the Appellate Body in  EC – Hormones .  The Appellate Body observed that, 
"[w]here the condition of observan ce of good veterinary practice (which is much the same condition 
attached to the standards, guidelines and recommendations  of Codex with respect to the use of the five 
hormones for growth promotion) is  not  followed, the logical inferen ce is that the use of such 
hormones for growth promotion pur poses may or may not be 'safe'."1149   
553. The Panel does not address the evidence on misuse or abuse referred to in the 1999 and 2002 
Opinions in its analysis under Article 5.1 of the  SPS Agreement .  Neither does the Panel discuss the 
testimony of the scientific experts that recognized the relevance of this evidence and the potential 
adverse effects of the misuse or abuse in the ad ministration of the hormones. The Panel summarily 
dismissed the relevance of the evidence on misuse or abuse stating that it relates to exposure 
assessment and adding that it is not necessary to address it given the finding that the European 
Communities had not evaluated  specifically  the possibility that the adve rse effects arise from the 
consumption of meat from cattle treated with oestradiol-17 β for growth-promotion purposes.  We 
recognize that the 1999 Opinion examines the risks of misuse or abuse under the heading "Exposure 
considerations upon misuse".1150  After discussing the evidence on misuse and abuse, the 2002 
Opinion states that "these data have to be considered in any quantitative exposure assessment 
exercise."1151  This, however, cannot justify the Panel's failure to address the evidence on misuse or 
abuse.  The European Communities made it clear that  the risks of abuse or misuse were a relevant 
consideration in its risk assessment.  This is conf irmed in the 1999 and 2002 Opinions.  At least two 
of the scientific experts consulted by the Pane l recognized that the misuse or abuse in the 
administration of the hormones could give rise to a dverse effects.  The Panel had a duty to engage 
with this evidence and with the discussion of this  evidence in the SCVPH Opinions.  By summarily 
dismissing the evidence on the misuse or abuse in the administration of the hormones and the 
consequent conclusions in the SCVPH Opinions in  the manner that it did, the Panel incorrectly 
applied Article 5.1 and the definition of  "risk assessment" in Annex A of the SPS Agreement , as 
interpreted by the Appellate Body. 
554. The United States and Canada submit that there are no economic incentives to fail to observe 
good veterinary practices by, for example, gi ving higher doses of hormones to the cattle.1152  This is 
something the Panel could have examined, but it di d not.  Therefore, it cannot justify the Panel's 
inadequate treatment of the issue. 
                                                      
1149Appellate Body Report, EC – Hormones , para. 206. (original emphasis;  footnote omitted) 
11501999 Opinion, p. 30. 
11512002 Opinion, p. 12. 
1152Canada's appellee's submission, para. 87;  and United States' responses to questioning at the oral 
hearing. WT/DS321/AB/R 
Page 234  
 
555. Accordingly, we find
 that the Panel erred in its interpreta tion and application of Article 5.1 of 
the  SPS Agreement   in relation to risks of misuse and a buse in the administration of hormones to 
cattle for growth-promoting purposes. 
3. The Panel's Specificity Requirement  
556. The European Communities claims that the Panel erred in finding that the European 
Communities had acted inconsistently with Article 5.1 of the  SPS Agreement  by failing to evaluate 
specifically the risks arising from residues of oestradiol-17 β in meat from cattle treated with this 
hormone for growth promotion.  The European Communities argues that "[a]t no stage did the Panel[] 
correctly identify what the Appellate Body found to be wanting in the risk assessments carried out for 
the purposes of Directive 96/22/EC in the original hormones dispute."1153   
557. Relying on the Appellate Body's findings in EC – Hormones , the Panel observed that "a risk 
assessment in this instance required not a genera l evaluation of the carcinogenic potential of entire 
categories of hormones, but rather should include an  examination of residues of those hormones found 
in meat derived from cattle to which the hormon es had been administered for growth promotion 
purposes."1154  The Panel also noted the Appellate Body's finding in Japan – Apples that "a risk 
assessment should refer in general to the harm concerned as well as to the precise agent that may 
possibly cause the harm"1155, and its explanation that "an evaluation of risk must connect the 
possibility of adverse effects with an antecedent or cause."1156  The Panel concluded:  
[T]he European Communities was requi red to evaluate the possibility 
that the identified adverse effect came into being, originated, or 
resulted from the presence of residues of oestradiol-17 β in meat or 
meat products as a result of the cattle  being treated with the hormone 
for growth promoting purposes.1157 
558. The European Communities alleges that the Panel improperly require d demonstration of 
actual  effects while the Appellate Body had required mere demonstration of the  possibility of adverse 
effects.1158  The European Communities' allegation is unfounded.  In the statement quoted above, the 
Panel focused on the possibility  that the adverse effects could arise from the consumption of meat
                                                      
1153European Communities' appellant's submission, para. 341. 
1154Panel Report, US – Continued Suspension , para. 7.511;  Panel Report, Canada – Continued 
Suspension , para. 7.483 (referring to Appellate Body Report, EC – Hormones , para. 200).  
1155Panel Report, US – Continued Suspension , para. 7.512;  Panel Report, Canada – Continued 
Suspension , para. 7.484 (referring to Appellate Body Report, Japan – Apples , para. 202). (emphasis omitted) 
1156Ibid. (quoting Appellate Body Report, Japan – Apples , footnote 372 to para. 202).  
1157Panel Report, US – Continued Suspension , para. 7.513;  Panel Report, Canada – Continued 
Suspension , para. 7.485.  
1158European Communities' appellant's submission, para. 261.  WT/DS321/AB/R 
 Page 235 
 
 
from cattle treated with oestradiol-17 β.  The test articulated by the Panel is compatible with the 
definition of the term "risk assessment" in paragraph 4 of Annex A of the  SPS Agreement  and with 
the interpretation developed by the Appellate Body in EC – Hormones .  In that dispute, the European 
Communities presented a number of scientific studies and opinions of individu al scientists indicating 
that the hormones at issue in th at case had "carcinogenic potential".1159  Yet, the Appellate Body 
found that those studies fell short of the require ments of paragraph 4 of Annex A of the  SPS 
Agreement , because: 
The 1987 IARC Monographs and the articles and opinions of 
individual scientists submitted by the European Communities 
constitute general studies which do in deed show the existence of a 
general risk of cancer; but they do not focus on and do not address the particular kind of risk here at stake—the carcinogenic or genotoxic potential of the residues of those hormones found in meat derived from cattle to which the hor mones had been administered for 
growth promotion purposes—as is  required by paragraph 4 of 
Annex A of the SPS Agreement .  Those general studies, are in other 
words, relevant but do not appear to be sufficiently specific to the 
case at hand.
1160  
559. The definition of a risk assessment in paragraph 4 of Annex A, as interpreted by the Appellate 
Body, required the European Communities to conduc t a risk assessment that addresses the specific 
risk at issue.  The particular risk being evalua ted by the European Communities in this case was the 
potential for neurobiological, developmental, repr oductive, and immunological effects, as well as 
immunotoxic, genotoxic and carcinogenic effects1161 from the residues of oestradiol-17 β found in 
meat derived from cattle to which this hormone wa s administered for growth-promoting purposes.  
Although the European Communities is correct in ar guing that it was not required to demonstrate that 
these adverse health effects would actually arise, it was nevertheless required to demonstrate that 
these adverse effects could arise from the presence of residues of oestradiol-17 β in meat from treated 
cattle.  In our view, this is what the Panel required when it examined whether the European 
Communities had "evaluate[d] the possibility that th e identified adverse effect ... resulted from the 
presence of residues of oestradiol-17 β in meat or meat products as a result of the cattle being treated 
with the hormone for growth promoting purposes."1162   
                                                      
1159Appellate Body Report, EC – Hormones , para. 199.  
1160Ibid., para. 200.  
1161Panel Report, US – Continued Suspension , para. 7.508;  Canada  – Continued Suspension , 
para. 7.480 (referring to 1999 Opinion, p. 72).  
1162Panel Report, US – Continued Suspension , para. 7.513;  Canada – Continued Suspension , 
para. 7.485.  WT/DS321/AB/R 
Page 236  
 
560. The European Communities also argues that the Panel erred by requiring a demonstration of 
"direct causality", which the Europ ean Communities posits constitutes "a very narrow reading" by the 
Panel of the definition of risk assessment in paragraph 4 of Annex A.
1163   
561. The Appellate Body explained in Japan – Apples that:  
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.
1164   
562. The particular risk being assessed by the Europ ean Communities is the possibility of adverse 
health effects from the consumption of residues of oestradiol-17 β in meat treated with this hormone 
for growth promotion.  In EC – Hormones , the Appellate Body requi red evaluation of "the 
carcinogenic or genotoxic potential of the residues of [the] hormones"1165 at issue found in meat from 
treated cattle.  In this case, the European Commun ities had to evaluate whether a causal connection 
exists between the consumption of meat  from cattle treated with oestradiol-17 β and the possibility of 
adverse health effects.  This does not mean that  the European Communities was required to establish a 
direct causal relationship between the possibility of adverse health effects and the residues of 
oestradiol-17 β in bovine meat.  In order to meet the re quirements of Article 5.1 and Annex A of the 
SPS Agreement , it was sufficient for the European Commun ities to demonstrate that the additional 
human exposure to residues of oestradiol-17 β in meat from treated cattle is one of the factors 
contributing to the possible adverse health effect s.  The European Communities was not required to 
isolate the contribution made by residues of oestradiol-17 β in meat from cattle treated with the 
hormone for growth promotion from the contributions made by other sources.1166  Where multiple 
factors may contribute to a particular risk, a risk ass essor is not required to differentiate the individual 
contribution made by each factor.  Article 5.1 requires that SPS measures be based on a risk 
assessment "as appropriate to the circumstances", which suggests that the scientific inquiry involved 
in a risk assessment must take due account of particular methodological difficulties posed by the 
nature and characteristics of the particular substance and risk being evaluated.  However, that does not 
                                                      
1163European Communities' appellant's submission, para. 260.  
1164Appellate Body Report, Japan – Apples , footnote 372 to para. 202.   
1165Appellate Body Report, EC – Hormones , para. 200.  
1166In this respect, we recall that in EC – Hormones , the Appellate Body considered that "there is a 
fundamental distinction between added hormones (natural or synthetic) and naturally-occurring hormones in meat and other foods." ( Ibid., para. 221)  It also noted that regulatory action in respect of the latter would 
"entail[] such a comprehensive and massive governmental intervention in nature and in the ordinary lives of 
people" as to reduce the comparison between these types of hormones "to an absurdity". ( Ibid.)  WT/DS321/AB/R 
 Page 237 
 
 
excuse the risk assessor fro m evaluating whether there is a connection between the particular 
substance being evaluated and the possibility that adverse health effects may arise.  
563. Finally, we are not persuaded by the Eur opean Communities suggestion that the Panel 
required testing in humans in order to specifically evaluate the risks associat ed with the consumption 
of meat from cattle treated with oestradiol-17 β.1167  We do not see this as a necessary implication of 
the Panel's analysis.  There is no indication in th e Panel Report to suggest that the evaluation could 
not proceed on the basis of experimentation in labo ratory animals and extrapolating the results to 
humans, or by other means.  Certainly, where a s ubstance may be potentially toxic, requiring a WTO 
Member to evaluate specifically the risks through actual human consumption of the substance would 
be unethical and would not be "appropriate to the ci rcumstances" within the meaning of Article 5.1. 
564. For these reasons, we find  that the Panel did not err in requiring a specific evaluation of the 
risks arising from the presence of residues of oestradiol-17 β in meat or meat products from cattle 
treated with the hormone for growth-promoting purposes.1168 
565. The European Communities makes two additional arguments relating to the specificity 
requirement.  First, the European Communities asserts that the Panel's analysis and the legal test it 
used "are simply a cover for allowing the Panel[] to decide  what the correct science in [its] view is , 
not on assessing whether the scientific evidence ev aluated in the Opinions of the SCVPH  focussed on 
and addressed  'the particular kind of risk here at st ake—carcinogenic or genotoxic potential of the 
residues of those hormones found in meat derived from cattle to which [17 β-oestradiol] had been 
administered for growth promotion purposes', as id entified by the Appellate Body in the original 
case."1169  Second, the European Communities ar gues that, because the SCVPH Opinions 
demonstrated that oestradiol-17 β is a "complete carcinogen by exerting tumour initiating and 
promoting effects", "it has to be concluded that no quantitative estimate of risk related to residues in 
meat could be presented".1170  According to the European Co mmunities, "[t]his conclusion alone 
demonstrates that the Opinions focussed on and addressed very specifically the particular kind of risk 
here at stake—carcinogenic and genotoxic potential of the residues of those hormones found in meat 
derived from cattle to which [17 β-oestradiol] had been administered for growth promotion purposes 
as identified by the Appellate Body."1171  In our view, both of these argum ents relate to the standard of
                                                      
1167European Communities' appellant's submission, para. 263.  
1168Panel Report, US – Continued Suspension , para. 7.513;  Panel Report, Canada – Continued 
Suspension , para. 7.485.  
1169European Communities' appellant's submission, para. 341. (original emphasis).   
1170Ibid., para. 337. 
1171Ibid. (original emphasis and footnote omitted)  WT/DS321/AB/R 
Page 238  
 
review applied by the Panel and to the Panel's eval uation of the evidence before it.  We address this 
aspect of the European Communities' appeal in section VI.D.6. 
4. Quantification of Risk
 
566. Next, we turn to the European Communities' claim that the Panel erred in requiring the 
quantification of the risks arising from the consump tion of meat containing residues of oestradiol-17 β.  
The European Communities asserts that, by referring to "potential occurrence"1172 of adverse effects 
when asking questions to the experts, the Panel incorrectly "imposed a quantitative method of risk 
assessment on the European Communities borro wed from Codex Alimentarius and JECFA."1173 
567. In  EC – Hormones , the Appellate Body held that:  
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.
1174  
(footnote omitted) 
568. The Appellate Body further stated that:  
It is not clear in what sense the Panel uses the term "scientifically 
identified risk."  The Panel also fre quently uses the term "identifiable 
risk", and does not define this term either.  The Panel might arguably have used the terms "scientifically  identified risk" and "identifiable 
risk" simply to refer to an ascertainable risk:  if a risk is not ascertainable, how does a Member ever know or demonstrate that it exists?  In one part of its Repor ts, the Panel opposes a requirement of 
an "identifiable risk" to the uncer tainty that theoretically always 
remains since science can never  provide absolute  certainty that a 
given substance will not ever have adverse health effects.  We agree 
with the Panel that this theoretical uncertainty is not the kind of risk which, under Article 5.1, is to be assessed.  In another part of its 
Reports, however, the Panel appe ared to be using the term 
scientifically identified risk" to prescribe implicitly that a certain magnitude or threshold level of risk be demonstrated in a risk 
assessment if an SPS measu re based thereon is to be regarded as 
consistent with Article 5.1.  To th e extent that the Panel purported to 
require a risk assessment to establish a minimum magnitude of risk, 
we must note that imposition of such a quantitative requirement finds 
                                                     
 
1172European Communities' appellant's submission, para. 346. 
1173Ibid., para. 308.  
1174Appellate Body Report, EC – Hormones , para. 184.  WT/DS321/AB/R 
 Page 239 
 
 
no basis in the SPS Agreement .1175  (original emphasis;  footnotes 
omitted;) 
569. Although the definition of a risk assessment does not require WTO Members to establish a 
minimum magnitude of risk, it is nevertheless di fficult to understand the concept of risk as being 
devoid of any indication of potentiality.  A risk assess ment is intended to identify adverse effects and 
evaluate the possibility that such a dverse effects might arise.  This distinguishes an ascertainable risk 
from theoretical uncertainty.  However, the assessm ent of risk need not be expressed in numerical 
terms or as a minimum quantification of the level of risk.  We are also mindful that the risk assessment at issue in this case concerns the  potential  for adverse effects under the second sentence 
of paragraph 4 of Annex A and not an evalua tion of likelihood under the first sentence of 
paragraph 4.
1176   
570. The European Communities' challenge in this cas e is directed at the following question that 
the Panel posed to the scientific experts: 
The Panel specifically asked the experts whether the [European 
Communities]  Opinions identified the potential for adverse effects on 
human health, including the carcinogenic or genotoxic potential, of the residues of oestradiol-17 β found in meat derived from cattle to 
which this hormone had been administered for growth promotion 
purposes in accordance with good veterinary practice and to what 
extent the Opinions evaluated the potential occurrence of these 
adverse effects.
1177 
571. The European Communities does not consider this formulation to be "problematic" as such.  
The European Communities argues, however, that if  this formulation is understood as requiring a 
Member to specify in quantitative term s "to what extent [it] evaluated  the potential occurrence  of 
these adverse effects"1178, it would lead to an error in law.  The European Communities submits that 
this is precisely how the Panel addressed the i ssue and how it invited the experts to analyse the 
SCVPH Opinions.1179 
                                                      
1175Appellate Body Report, EC – Hormones , para. 186.  Similarly, in Australia – Salmon , the Appellate 
Body referred to the first sentence of the definition of a "risk assessment" in paragraph 4 of Annex A of the  SPS 
Agreement , and noted 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." (Appellate Body 
Report, Australia – Salmon , para. 124)  
1176The Appellate Body found in EC – Hormones that the term "potential" in the second sentence of 
paragraph 4 of Annex A refers to the "possibility" of occurrence of adverse eff ects, which implies a lower 
degree of potentiality than "probability".  (Appellate Body Report, EC – Hormones , para. 184).  
1177Panel Report, US – Continued Suspension , para. 7.521;  Panel Report, Canada – Continued 
Suspension , para. 7.493. 
1178European Communities' appellant's submission, para. 344 (quoting Panel Report, US – Continued 
Suspension , para. 7.521;  and Panel Report, Canada – Continued Suspension , para. 7.493) (original emphasis) 
1179Ibid., para. 344. (footnote omitted) WT/DS321/AB/R 
Page 240  
 
572. As the European Communities acknowledges,  "a quantitative dimension may not be 
immediately evident from the ordinary mean ing of the words 'potential occurrence'."
1180  T he  te r m s  
"potential occurrence of adverse effects" can be understood as referring to the possibility that the 
adverse effects might occur, without necessarily requiri ng that this be expressed in numerical terms.  
This would be consistent with the definition of "risk assessment" in paragraph 4 of Annex A of the 
SPS Agreement , as interpreted by the Appellate Body.  Mo reover, it would be consistent with the 
Appellate Body's view that "theoretical uncertainty"1181 is not the kind of risk to be assessed under 
Article 5.1, but rather the risk to be assessed must be an "ascertainable" risk.1182  In this sense, we 
agree with Canada that "to examine the 'potential' for adverse effects is to ask whether those adverse 
effects could ever occur ".1183  
573. Other statements by the Panel confirm that it di d not require that the possibility of the risks 
arising be expressed in numerical terms.  For exam ple, the Panel took note of the Appellate Body's 
finding that a risk assessment can take into account  "matters not susceptible of quantitative analysis 
by the empirical or experimental laboratory me thods commonly associated with the physical 
sciences."1184  The Panel also stated that "it must determine whether the European Communities 
evaluated the possibility  that the identified adverse effects ca me into being, originated, or resulted 
from the presence of residues of oestradiol-17 β in meat or meat products as a result of the cattle being 
treated with the hormone for growth promotion purposes."1185   
574. The European Communities additionally draws a ttention to the Panel's use of the term 
"magnitude" in the following statement: 
Indeed, whether a Member considers that its population should be 
exposed or not to a particular risk, or at what level, is not relevant to 
determining whether a risk exists and what its magnitude  is. A 
fortiori , it should have no effect on whether there is sufficient 
evidence of the existence and magnitude of this risk. 
A risk-averse Member may be inc lined to take a protective position 
when considering the measure to be adopted.  However, the 
determination of whether scientific evidence is sufficient to assess 
                                                      
1180European Communities' appellant's submission, para. 346. 
1181Appellate Body Report, EC – Hormones , para. 186.  
1182In Japan – Apples , the Appellate Body cautioned, however, th at "scientific prudence" should "not 
be 'completely assimilated'" to such theoretical uncertainty. (Appellate Body Report, Japan – Apples , para. 241) 
1183Canada's appellee's submission, para. 107. (original underlining) 
1184Panel Report, US – Continued Suspension , para. 7.520;  Panel Report, Canada – Continued 
Suspension , para. 7.492 (quoting Appellate Body Report, EC – Hormones , para. 187). 
1185Panel Report US – Continued Suspension , para. 7.520;  Panel Report, Canada – Continued 
Suspension , para. 7.492.  (emphasis added)  WT/DS321/AB/R 
 Page 241 
 
 
the existence and magnitude  of a risk must be disconnected from the 
intended level of protection.1186  (emphasis added) 
We note that these statements were made by the Panel in its discussion of the consistency of the 
European Communities' provisional ban in respect of the other fives hormones and, therefore, was not 
made in the context of the Panel's examination of the European Communities' import ban on meat 
from cattle treated with oestradiol-17 β.  However, we recall that a "risk assessment" involves an 
indication of potentiality, even though this need not be expressed in numerical terms or as a minimum 
quantification of the level of risk.  In this sense, the Panel's reference to "magnitude" is in our view 
not sufficient to establish that the Panel incorrectly interpreted Artic le 5.1 and paragraph 4 of Annex 
A as requiring a quantitative risk assessment.   
575. For these reasons, we consider that the Panel's reference to "potential occurrence" of adverse 
health effects could be read cons istently with the definition of a risk assessment in paragraph 4 of 
Annex A of the  SPS Agreement , as interpreted by the Appellate Body.  Accordingly, we dismiss  the 
European Communities' claim that the Panel incorr ectly interpreted Article 5.1 and paragraph 4 of 
Annex A of the  SPS Agreement  as requiring quantification of risk. 
5. Burden of Proof  
576. We now examine the European Communities' cl aim that the Panel erred by incorrectly 
allocating the burden of proof.  The European Co mmunities argues that the fact that it is the 
complaining party in this case "does not change th e basic standard on the burden of proof under the 
SPS Agreement ."1187  According to the European Communities,  the Panel "erred in law in shifting the 
burden of proof to the European Communities wit hout first examining, provision by provision under 
the  SPS Agreement  as required by Appellate Body, whethe r the arguments of the United States and 
Canada had sufficient merits to shift the burde n of proof back to the European Communities".1188  
577. The United States argues that the Panel was corre ct in initially allocating to the European 
Communities the burden of proving its claim that the United States acted inconsistently with 
Article 22.8 of the DSU.  The United States consider s that the Panel properly found that the European 
Communities' claim was premised on an assertion by  the European Communities that it had brought 
itself into conformity with the  SPS Agreement  through Directive 2003/74/EC.  For this reason, the 
Panel was justified in allocating to the Eur opean Communities the burden of establishing a  prima 
facie  case of conformity with the  SPS Agreement , including Article 5.1.  The United States accepts 
                                                      
 1186Panel Report, US – Continued Suspension , paras. 7.611 and 7.612;  Panel Report, Canada – 
Continued Suspension , paras. 7.589 and 7.590. 
1187European Communities' appellant's submission, para. 286. 
1188Ibid., para. 294. WT/DS321/AB/R 
Page 242  
 
that, once the Panel found that the Euro pean Communities had established such  prima facie  case, the 
burden of proof shifted to the United States.  However, the Panel then rightly found that the United 
States had rebutted the European Communities'  prima facie  case of consistency through positive 
evidence of breach of the  SPS Agreement .  On this basis, the United States suggests that "the burden 
shifted back and forth between the parties and eventua lly 'neutralized' each other since each party also 
submitted evidence in support of its allegations."
1189 
578. Canada agrees with the United States that the European Communities has the burden of 
proving that it has removed the inconsistent meas ure within the meaning of Article 22.8 of the 
DSU.1190  Canada asserts that, in order to demonstrate that the suspension of concessions is no longer 
justified, the European Communities must establis h that it has brought its measure into compliance 
with Article 5.1 of the  SPS Agreement . 
579. The Panel explained how it would allo cate the burden of proof as follows: 
With respect to the violation of Article 22.8 as such, the Panel 
considered that it had, in principl e, no reason to address [the] burden 
of proof any differently than any other panel established under 
Article 6 of the DSU.  Indeed, as stated by the Complainant itself, 
this case is about a measure taken by [the United States and Canada].  The fact that this dispute takes pl ace in the context of the [European 
Communities'] alleged compliance with the recommendations and rulings of the DSB in the EC – Hormones  dispute should have no 
impact on the question of the burden of proof regarding the actual 
claim  before us.  This means that the principles identified by the 
Appellate Body above apply, and that the European Communities must prove its claim that [the United States and Canada] breach[] 
Article 22.8 of the DSU. 
Yet, one of the particularities of this case is that the [European 
Communities'] claim of violation of Article 22.8 of the DSU by [the 
United States and Canada] is pr emised on the removal of the 
European Communities' measure found to be inconsistent with the 
SPS Agreement . In other words, in order to demonstrate that [the 
United States and Canada have] brea ched Article 22.8, the European 
Communities also alleges that its implementing measure is itself in 
conformity with the SPS Agreement . 
In theory, this should not raise any difficulty in terms of burden of 
proof since it is well established that each party has to prove its own allegations.  We agree, however, with the European Communities that in a case like this one, this c ould generate for the complainant at 
the beginning of the proceedings a situation equivalent to having to 
"prove a negative", since the spectrum of provisions against which 
                                                     
 
1189United States' appellee's submission, para. 94 (referring to Panel Report, US – Continued 
Suspension , para. 7.386). 
1190Canada's responses to questioning at the oral hearing.    WT/DS321/AB/R 
 Page 243 
 
 
the legality of the [European Commun ities']  measure may have to be 
reviewed remains very broad as long as the respondent has not made its own allegations of inconsiste ncy of the implementing measure.  
However, we recall that we found above that the European Communities enjoyed a presumption of good faith compliance, even 
though that presumption was rebuttable before this Pane l.  As soon as 
the European Communities established a prima facie case thanks to the presumption of good faith compliance, the burden shifted on the [the United States and Canada] to rebut that presumption.  We recall that "... a prima facie case is one which, in the absence of effective 
refutation by the defending party, re quires a panel, as a matter of law, 
to rule in favour of the complaining party presenting the prima facie case." We believe that the [United States and Canada] sufficiently refuted the [European Communities' ] allegation of compliance in 
[their] first written submission thr ough positive evidence of breach of 
the SPS Agreement  by the European Communities.  In its subsequent 
submissions before the Panel, the European Communities responded 
to the allegations of violation made by [the United States and Canada].  Thus, the European Communities never actually had to "prove a negative" in this case.   
While the presumptions based on good faith enjoyed by each party 
may have played a role in the burden of proof in the early stage of the 
Panel proceedings, it is the opinion of the Panel that they eventually "neutralized" each other since each party also submitted evidence in 
support of its allegations.  Ultimately, each party had to prove its specific allegations in response to the evidence submitted by the 
other party.  Thereafter, when c onsidering whether an allegation had 
been proven or not, the Panel followed the practice of other panels to weigh all the evidence before it.
1191  (original emphasis:  footnotes 
omitted) 
580. In section IV, we explained that this case involves a disagreement as to the consistency of a 
measure taken to comply and, therefore, should ha ve properly been brought under Article 21.5 of the 
DSU.  We also explained how the burden of proof should have been allocated had the dispute been 
brought under Article 21.5.  Although these proceedi ngs were not brought under Article 21.5, the 
Panel said that it "perform[ed] functions si milar to those of an Article 21.5 panel".1192  The European 
Communities had to provide a clear description of its implementing measure, and an adequate explanation regarding how this measure rectifies th e inconsistencies found in the original proceedings, 
so as to have placed the Panel in a position to make  an objective assessment of the matter and, in the 
absence of rebuttal, to rule in fa vour of the original respondent.  Therefore, to the extent the Panel did 
not allocate the burden of proof in its analysis of whether Directive 2003/74/EC met the requirements 
                                                     
 
1191Panel Report, US – Continued Suspension , paras. 7.383-7.386;  Panel Report, Canada – Continued 
Suspension , paras. 7.380-7.383. 
1192Panel Report, US – Continued Suspension , para. 7.376;  Panel Report, Canada – Continued 
Suspension , para. 7.373. WT/DS321/AB/R 
Page 244  
 
of Article 5.1 of the  SPS Agreement  according to the principles outlined above, we find that the 
Panel has erred.  
581. We have, moreover, several additional concerns  with the Panel's analysis.  First, as we 
indicated in section IV, we do not believe that it w as sufficient for the European Communities to have 
based its case under Article 22.8 on a presumption of  good faith.  The European Communities may be 
presumed to have acted in good faith in adopting Directive 2003/74/EC, but this does not respond to 
the question as to whether Directive 2003/74/EC achieved substantive compliance.  Thus, it was 
incorrect for the Panel to have relied on a presumption of good faith compliance for purposes of determining the allocation of the burden of proof and finding that the European Communities established a  prima facie  case. 
582. Secondly, we have difficulty following the re asoning behind the Panel's conclusion that the 
presumptions of good faith enjoyed by each party "eventually 'neutralized' each other" and that 
"[u]ltimately, each party had to prove its specific a llegations in response to the evidence submitted by 
the other party."
1193  The statement is ambiguous about whic h party made which allegation and how 
the burden of proof was allocated.  In the section in  which the Panel describes the scope of its review 
and circumscribes its terms of reference, the Panel states that, in submissions subsequent to the first 
written submission, "the European Communities h as argued the compatibility of its implementing 
measure with the provisions referred to in the quot ation above (i.e. Article[s] 5.1 and 5.7 of the  SPS 
Agreement )".1194  However, a few paragraphs later, the Pane l refers to the allegation of incompatibility 
with Article 5.1 of the  SPS Agreement  as an allegation made by the United States and Canada.1195  
Thus, it is difficult to unders tand which party had the burden of proving which allegation. 
583. Thirdly, we note the Panel's statement that th e United States and Canada "sufficiently refuted 
the [European Communities'] allegation of complia nce in [their] first written submission through 
positive evidence of breach of the  SPS Agreement  by the European Communities".1196  T h i s  
statement is made before the Panel has undert aken any analysis of the conformity of 
Directive 2003/74/EC with Article 5.1 of the SPS Agreement .  In its appellant's submission, the 
European Communities takes issue with this statem ent and argues that the Panel should have first 
examined "provision by provision ... whether the arguments of the United States and Canada had 
                                                      
1193Panel Report, US – Continued Suspension , para. 7.386;  Panel Report, Canada – Continued 
Suspension , para. 7.383. 
1194Panel Report, US – Continued Suspension , para. 7.400;  Panel Report, Canada – Continued 
Suspension , para. 7.397.  
1195Panel Report, US – Continued Suspension , para. 7.405;  Panel Report, Canada – Continued 
Suspension , para. 7.398.  
1196Panel Report, US – Continued Suspension , para. 7.385;  Panel Report, Canada – Continued 
Suspension , para. 7.382.  WT/DS321/AB/R 
 Page 245 
 
 
sufficient merits to shift the burden of proof back to the European Communities".1197  We agree that it 
was premature for the Panel to have stated th at the United States and Canada had succeeded in 
refuting the European Communities' allegation of  compliance before the Panel had addressed the 
consistency of Directive 2003/74/EC with the  SPS Agreement .   
584. Accordingly, we find  that the Panel erred in the allocation of the burden of proof in its 
assessment of the consistency of Directiv e 2003/74/EC with Article 5.1 of the  SPS Agreement .  We 
discuss the consequences of this error in section E below. 
6. The Panel's Articulation and Applicati on of the Standard of Review under 
Article 5.1 of the  SPS Agreement   
585. We turn next to the European Communities' clai m that the Panel erred in the standard that it 
applied to review whether Directive 2003/74/EC w as based on a risk assessme nt within the meaning 
of Article 5.1 of the  SPS Agreement . The European Communities argues that the Panel sought to 
determine "what the correct scientific conclusions are"1198 in relation to the hormones at issue.  The 
European Communities adds that, instead of dete rmining whether "there was any reputable support 
within the relevant scientific co mmunity for the determination made  by the European Communities in 
the light of its chosen level of protection"1199, the Panel decided "to become the jury on the correct 
science ... by picking and choosing between conflicting and contradictory opinions of the experts in 
an arbitrary manner."1200  As a result, the Panel impermissibly engaged in a  de novo  review of the 
European Communities' risk assessment, and failed to take into account diverging views among the 
experts reflecting a "genuine and legitimate scientific controversy"1201 concerning three particular 
issues: exposure of humans to hormones fro m multiple endogenous and exogenous sources;  
genotoxicity of oestradiol-17 β;  and specificity or direct causality.1202 
586.  The United States and Canada consider that the Panel identified and applied the correct 
standard of review to the facts before it, and ma intain that the Panel did not exceed the bounds of its 
discretion as the trier of facts when assessing th e weight and determining the credibility to be 
attributed to the opinions of the scientific experts. 
587. We discuss our views on the applicable standard of review before turning to our examination 
of the Panel's assessment of Directive 2003/74/E C.  The European Comm unities claims that the
                                                      
1197European Communities' appellant's submission, para. 294. 
1198Ibid., para. 240.  
1199Ibid. 
1200Ibid., para. 239. (emphasis added) 
1201Ibid., para. 248.  
1202Ibid.  WT/DS321/AB/R 
Page 246  
 
appropriate standard of review is  one which limits a panel's mandate to determining whether there is 
any "reasonable scientific basis" for the SPS measure.
1203  The United States and Canada object to 
such a standard.  We recall that in EC – Hormones , the Appellate Body rejected the European 
Communities' argument that a "deferential 'reas onableness' standard" is applicable under the SPS 
Agreement  to "all highly complex factual situations, in cluding the assessment of the risks to human 
health arising from toxins and contaminants".1204  The Appellate Body cautioned that the applicable 
standard of review "must reflect the balance established in [the  SPS Agreement ] between the 
jurisdictional competences conceded by the Member s to the WTO and the jurisdictional competences 
retained by the Members for themselves" and concluded that Article 11 of the DSU "articulates with great succinctness but with sufficient clarity the appropriate standard of review for panels"
1205 
reviewing the assessment of facts under the  SPS Agreement . 
588. Article 11 of the DSU states, in relevant part: 
[A] panel should make an objective assessment of the matter before 
it, including an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements.   
589. The Appellate Body has observed that, so far as fact-finding by panels is concerned, the 
applicable standard is "neither  de novo  review as such, nor 'total deference', but rather the 'objective 
assessment of facts'".
1206  It further explained that, while panels  are "poorly suited to engage in [a  de 
novo ] review", "'total deference to the findings of the national authorities' ... 'could not ensure an 
"objective assessment" as foreseen by Article 11 of the DSU'."1207   
590. A panel reviewing the consistency of an SPS measure with Article 5.1 must determine 
whether that SPS measure is "based on" a risk assessmen t.  It is the WTO Member's task to perform 
the risk assessment.  The panel's task is to review  that risk assessment.  Where a panel goes beyond 
this limited mandate and acts as a risk assessor, it would be substituting its own scientific judgement 
for that of the risk assessor and making a  de novo  review and, consequently, would exceed its 
functions under Article 11 of the DSU.  Therefore, the review power of a panel is not to determine 
whether the risk assessment undertak en by a WTO Member is correct, but rather to determine whether 
that risk assessment is supported by coherent reas oning and respectable scientific evidence and is, in 
this sense, objectively justifiable. 
                                                      
1203European Communities' appellant's submission, para. 243. 
1204Appellate Body Report, EC – Hormones , paras. 113 and 114. 
1205Ibid., paras. 115 and 116. 
1206Ibid., para. 117.  
1207Ibid. (quoting Panel Report, US – Underwear , para. 7.10).  WT/DS321/AB/R 
 Page 247 
 
 
591. The Appellate Body has observed that a WTO Member may properly base an SPS measure on 
divergent or minority views, as long as these views are from qualified and respected sources.1208  This 
must be taken into account in defining a panel's st andard of review.  Accordingly, a panel reviewing 
the consistency of an SPS measure with Article 5.1 of the  SPS Agreement  must, first, identify the 
scientific basis upon which the SPS measure was adopted .  This scientific basis need not reflect the 
majority view within the scientific community but may reflect divergent or minority views.  Having 
identified the scientific basis underlying the SPS meas ure, the panel must then verify that the 
scientific basis comes from a respected and qualified source.  Although the scientific basis need not 
represent the majority view within the scientific community, it must nevertheless have the necessary 
scientific and methodological rigour to be considered  reputable science.  In other words, while the 
correctness of the views need not have been accep ted by the broader scientific community, the views 
must be considered to be legitimate science accord ing to the standards of the relevant scientific 
community.  A panel should also assess whether the reasoning articulated on the basis of the scientific 
evidence is objective and coherent.  In other word s, a panel should review whether the particular 
conclusions drawn by the Member assessing the risk  find sufficient support in the scientific evidence 
relied upon.  Finally, the panel must determine whet her the results of the risk assessment "sufficiently 
warrant" the SPS measure at issue.1209  Here, again, the scientific basis cited as warranting the SPS 
measure need not reflect the majority view of the scientific community provided that it comes from a 
qualified and respected source. 
592. A panel may and should rely on the advice of experts in reviewing a WTO Member's SPS 
measure, in accordance with Article 11.2 of the  SPS Agreement  and Article 13.1 of the DSU.  In 
doing so, however, a panel must respect the due process rights of the parties.1210  Moreover, a panel 
may not rely on the experts to go beyond its limite d mandate of review.  The purpose of a panel 
consulting with experts is not to pe rform its own risk assessment.  The role of the experts must reflect 
the limited task of a panel.  The panel may seek  the experts' assistance in order to identify the 
scientific basis of the SPS measure and to verify that this scientific basis comes from a qualified and 
respected source, irrespective of whether it represents  minority or majority scientific views.  It may 
also rely on the experts to review whether the reasoning articulated on the basis of the scientific 
evidence is objective and coherent, and whether th e particular conclusions drawn by the Member 
assessing the risk find sufficient support in the evid ence.  The experts may also be consulted on the 
relationship between the risk assessment and the SPS measure in order to assist the panel in 
determining whether the risk assessment "sufficien tly warrants" the SPS measure.  The consultations
                                                      
1208Appellate Body Report, EC – Hormones , para. 194. 
1209Ibid., para. 193. 
1210See supra , section V. WT/DS321/AB/R 
Page 248  
 
with the experts, however, should not seek to te st whether the experts would have done a risk 
assessment in the same way and would have reached  the same conclusions as the risk assessor.  In 
other words, the assistance of the experts is cons trained by the kind of review that the panel is 
required to undertake.   
593. In this case, the Panel correctly identified Artic le 11 of the DSU as setting out the standard of 
review applicable to its examination of the consis tency of the European Communities' risk assessment 
with Article 5.1 of the  SPS Agreement .
1211  The Panel also referred to the guidance provided by the 
Appellate Body in EC – Hormones  concerning the standard of review.1212  Moreover, the Panel made 
reference to the interpretation of Article 5.1 of the  SPS Agreement  developed by the Appellate Body 
in  EC – Hormones  and acknowledged that a risk assessment ma y be based on divergent or minority 
views.1213 
594. Next, the Panel referred to its consultations with scientific experts, noting that it had 
consulted six scientific experts individually, and not as  an expert review group.  The Panel stated that: 
Although the Panel is not carrying out its own risk assessment, its 
situation is similar in that it may benefit from hearing the full spectrum of experts' views and thus obtain a more complete picture both of the mainstream scientific opinion and of any divergent 
views.
1214 
595. The analogy that the Panel draws between its  situation and that of a risk assessor is 
unfortunate, but is not in itself a sufficient indication that the Panel incorrectly understood the 
applicable standard of review.  We do not think th at the Panel meant to suggest that it saw its task 
under Article 5.1 as requiring it to perform a risk as sessment.  At the beginning of the statement, the 
Panel expressly recognizes that it "is not carrying out its own risk assessment". 
596. The Panel then elaborated on the approach it w ould take in respect of the testimony of the 
experts: 
We note that, in some circumstances, only one or two experts have 
expressed their views on an issue.  Sometimes these views were 
similar or complemented each other.  In other circumstances, a larger 
number of experts expressed opinions and, sometimes, they expressed diverging opinions. While, on some occasions, we 
                                                     
 
1211Panel Report, US – Continued Suspension , para. 7.413;  Panel Report, Canada – Continued 
Suspension , para. 7.404. 
1212Panel Report, US – Continued Suspension , paras. 7.414-7.416;  Panel Report, Canada – Continued 
Suspension , paras. 7.405-7.407. 
1213Panel Report, US – Continued Suspension , para. 7.417;  Panel Report, Canada – Continued 
Suspension , para. 7.408 (quoting Appellate Body Report, EC – Hormones , para. 194). 
1214Panel Report, US – Continued Suspension , para. 7.418;  Panel Report, Canada – Continued 
Suspension , para. 7.409.  WT/DS321/AB/R 
 Page 249 
 
 
followed the majority of experts expressing concurrent views, in some others the divergence of views were such that we could not follow that approach and decide d to accept the position(s) which 
appeared, in our view, to be the most specific in relation to the question at issue and to be best supported by arguments and 
evidence.
1215  (footnotes omitted) 
597. The European Communities submits that "the ma jority view is not probative simply because 
it represents the majority".1216  We agree that automatically giving more weight to the testimony of the 
majority of experts would be too rigid an approach.  The fact that a majority  in the spectrum of the 
scientific experts consulted by the Panel had a particular view is not a proper basis for determining 
whether a WTO Member's risk assessment complies with the requirements of Article 5.1 and Annex A of the SPS Agreement .   
598. Looking at the Panel's analysis of whethe r the European Commun ities specifically assessed 
the risks arising from the consumption of m eat from cattle treated with oestradiol-17 β, we note that a 
significant portion of the Panel's reasoning consists of  summaries of the responses of the experts.  It is 
only after summarizing the experts' responses that the Panel describes some of the issues discussed in 
the 1999 Opinion.  Given the applicable standard of review and the role of the Panel that is 
determined by it, the Panel's analysis should have proceeded differently.  The Panel should have first 
looked at the European Communities' risk assessment.   It should then have determined whether the 
scientific basis relied upon in that risk assessment  came from a respected and qualified source.  The 
Panel should have sought assistance from the scien tific experts in confirming that it had properly 
identified the scientific basis underlying the Europe an Communities' risk assessment or to determine 
whether that scientific basis originated in a resp ected and qualified source.  The Panel should also 
have sought the experts' assistance in determining whether the reasoning articulated by the European 
Communities on the basis of the scientific evidence is  objective and coherent, so that the conclusions 
reached in the risk assess ment sufficiently warrant the SPS measure.   Instead, the Panel seems to have 
conducted a survey of the advice presented by the scientific experts and based its decisions on 
whether the majority of the experts, or the opinion that was most thoroughly reasoned or specific to the question at issue, agreed with the conclusion drawn in the European Communities' risk 
assessment.  This approach is not consistent with  the applicable standard of review under the  SPS 
Agreement . 
                                                     
 
1215Panel Report, US – Continued Suspension , para. 7.420;  Panel Report, Canada – Continued 
Suspension , para. 7.411.  At the interim stage, the Panel further explained that "in case of divergence of opinions 
between the experts, and having due regard to the comments of the parties and the clarifications provided by the 
experts at the meeting with the Panel, it was a sound appr oach to take into account, in  forming its own opinion,  
the opinions that were the most pr ecise and elaborate." (Panel Report, US – Continued Suspension , para. 6.72;  
Panel Report, Canada – Continued Suspension , para. 6.67).  
1216European Communities' appellant's submission, para. 240. WT/DS321/AB/R 
Page 250  
 
599. The Panel's flawed approach is evident in its analysis of the genotoxicity of oestradiol-17 β, 
one of the central issues in the Eu ropean Communities' risk assessment.
1217  The 1999 Opinion refers 
to several studies that investigated  the genotoxicity of oestradiol.1218  It also states that certain 
metabolites of oestradiol-17 β "have been found to be directly or indirectly genotoxic" and that "[t]his 
implies that 17- β oestradiol may act as tumor initiator as well as tumor promoter".1219  T h e  1 9 9 9  
Opinion goes on to state that "[t]his implies that any excess exposure towards 17- β oestradiol and its 
metabolites resulting from the consumption of meat and meat products presents a potential risk to 
public health in particular to those groups of the population which have been identified as particularly 
sensitive such as prepubertal children".1220  Finally, the 1999 Opinion explains that a threshold cannot 
be established for these genotoxic metabolites.1221  The European Communities explained that a 
"threshold" is the "level below which intakes from residue should be considered to be safe." 1222 
600. The genotoxicity of oestradiol-17 β is also examined in the 2002 Opinion, which concludes: 
Convincing data have been publis hed confirming the mutagenic and 
genotoxic potential of 17 β-oestradiol as a consequence of metabolic 
activation to reactive quinines.  In vitro  experiments indicated that 
oestrogenic compounds might  alter the expression of an array of 
genes.1223  (original emphasis) 
601. Following the approach that we outlined earlier regarding the applicable standard of review, 
the first step in the Panel's analysis should have been to identify what in the European Communities' 
risk assessment was the scientific basis for the conclusions on the genotoxicity of oestradiol-17 β;  
verify whether this scientific basis came from a respected and qualified source; and determine 
whether the reasoning articulated on the basis of that  scientific evidence is objective and coherent.  As 
a second step, the Panel should have pursued a sim ilar inquiry concerning the conclusion that the 
genotoxicity of oestradiol-17 β did not permit the establishment of  a threshold, as the European 
Communities submits.  In that context, the Panel w ould have sought the experts' view as to whether 
the conclusions reached by the European Comm unities can find support in the scientific evidence 
relied upon by the European Communities (even if the expert in question was of a different scientific 
view). 
                                                      
1217The United States characterizes the issue of ge notoxicity as a "central underpinning" of the 
European Communities' risk assessment relating to oestradiol-17 β.  (Panel Report, US – Continued Suspension , 
para. 7.543) 
12181999 Opinion, pp. 39-41. 
1219Ibid., p. 75. 
1220Ibid. 
1221Ibid. 
1222Panel Report, US – Continued Suspension , para. 4.238.  See also Panel Report, Canada – Continued 
Suspension , footnote 259 to para. 6.88.  
12232002 Opinion, p. 21.  WT/DS321/AB/R 
 Page 251 
 
 
602. Rather than turning first to the European Comm unities' risk assessment in order to identify the 
scientific basis for the conclusions on the genotoxicity of oestradiol-17 β, the Panel begins with a 
survey of the views of the scientific experts on this issue in general.  The Panel tries to justify its 
approach on its inability to ev aluate the evidence itself: 
The Panel is not in a position to evaluate the scientific data the 
SCVPH reviewed in drawing its c onclusions.  For this reason, the 
Panel consulted a group of scientif ic experts and asked them to 
evaluate the [European Communities'] Opinions as well as the 
underlying science.1224 
However, under the applicable standard of review, neither the Panel nor the experts it consulted were 
called upon to evaluate the correctness of the Euro pean Communities' risk assessment.  The Panel's 
role was more limited and consisted, as we explai ned earlier, of identifying the scientific basis and 
evidence relied upon in the risk  assessment; verifying that th e scientific evidence comes from 
respected and qualified sources; and determining whet her the reasoning articulated by the European 
Communities on the basis of the scientific evidence is objective and coherent.   
603. The summary of the experts' opinions, which c onstitutes the lengthiest portion of the Panel's 
reasoning, often appears to be a general discussion as to whether the genotoxicity of oestradiol-17 β is 
widely accepted by the broader scientific community, rather than a discussion of the evidence relied 
upon in the European Communities' risk assessment .  The Panel concludes that the "scientific 
evidence referred to in the Opinions does not suppor t the European Communities' conclusion that for 
oestradiol-17 β genotoxicity had already been demonstrated explicitly."1225  The Panel's conclusion 
appropriately focuses on the scientific evidence in th e SCVPH Opinions.  Yet, the Panel's reasoning 
reveals several flaws.  First, some of the experts seemed to accept th e European Communities' 
position on the genotoxicity of oestradiol-17 β.  For example, the Panel quotes the following opinion 
of Dr. Cogliano in its reasoning: 
Dr. Cogliano explained that "the [European Communities'] statement 
that a threshold cannot be identified reflects their view of genotoxic 
mechanisms, just as the contrary st atement that there is a threshold 
and that this threshold is above the levels found in meat residues 
reflects how Canada and the [U nited States] view genotoxic 
mechanisms.  Neither statement has been demonstrated by the 
                                                      
1224Panel Report, US – Continued Suspension , para. 7.553;  Panel Report, Canada – Continued 
Suspension , para. 7.521. 
1225Panel Report, US – Continued Suspension , para. 7.572;  Panel Report, Canada – Continued 
Suspension , para. 7.540 (referring to 1999 Opinion, p. 75). WT/DS321/AB/R 
Page 252  
 
scientific evidence, rather, they ar e different assumptions that each 
party uses in their interpretati on of the available evidence."
1226 
604. The Panel also refers to the following testimony of Dr. Cogliano: 
Dr. Cogliano stated in his written re sponses that the identification of 
oestradiol-17 β as a human carcinogen indicates that there are 
potential adverse effects on human health when oestrodiol-17 β is 
consumed in meat from cattle treated with hormones for growth 
promotion purposes.  At the meeting with the Panel, Dr. Cogliano 
clarified that the IARC has classified oestradiol-17 β as possibly 
carcinogenic based on sufficient eviden ce in experimental animals.  
The agents that are known to be carcinogenic in humans are the steroidal oestrogens, non-steroidal oestrogens, and various oestrogen-
progestin combinations as used either as birth-control pills or 
menopausal therapy.
1227 
605. The Panel should have addressed whether Dr. C ogliano's statements provided evidence that 
the European Communities' position on the genotoxicity of oestradiol-17 β had some acceptance in the 
scientific community, even if it did not constitute the majority view.  At the interim review, the Panel 
rejected the relevance of Dr. Cogliano's statement, explaining that "the SPS Agreement  requires an 
analysis that goes beyond the identification of a potential adverse effect".1228  According to the Panel, 
"[t]he analysis must include an examination of the pot ential for that adverse affect to come into being, 
originate, or result from the presence of the specifi c substance under review in food, beverages, or 
feedstuffs, in this case oestradiol-17 β in meat and meat products deri ved from cattle treated with the 
hormone for growth promotion purposes."   
606. There is no indication in the Panel's reasoni ng about how to reconcile Dr. Cogliano's 
statements with the Panel's conclusion that the scientific evidence in the SCVPH Opinions do not 
support the European Communities' conc lusions that "for oestradiol-17 β genotoxicity had already 
been demonstrated explicitly" or that th e "presence of residues of oestradiol-17 β in meat and meat 
products as a result of the cattle being treated with  the hormone for growth promotion purposes leads 
to increased cancer risk."1229 
                                                      
1226Panel Report, US – Continued Suspension , para. 7.559;  Panel Report, Canada – Continued 
Suspension , para. 7.527 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 186). 
1227Panel Report, US – Continued Suspension , para. 7.561;  Panel Report, Canada – Continued 
Suspension , para. 7.529 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 154, and transcript of the Panel meeting with the scientific experts, Panel Reports, 
Annex G, para. 327). 
1228Panel Report, US – Continued Suspension , para. 6.118;  Panel Report, Canada – Continued 
Suspension , para. 6.110. 
1229Panel Report, US – Continued Suspension , para. 7.572;  Panel Report, Canada – Continued 
Suspension , para. 7.540. (footnote omitted)  WT/DS321/AB/R 
 Page 253 
 
 
607. The genotoxicity of oestradiol-17 β also comes up in connection with the European 
Communities' conclusion that a threshold c ould not be established for oestradiol-17 β.  As with 
genotoxicity, the risk assessment would need to provi de a scientific basis for the conclusion that a 
threshold could not be established for oestradiol-17 β.  The Panel does not identify what was the 
scientific basis for this conclusion, as it should have done.  Rather, the Panel's reasoning reproduces 
the views of the experts on the issue of genotoxicity , with some of them mentioning the distinction 
between  in vivo  and  in vitro  genotoxicity.  The discussion se eks to establish whether the 
genotoxicity  in vivo  of oestradiol-17 β had been accepted by the general scientific community, rather 
than whether the European Communities' risk assessment provided scientific evidence of the 
genotoxicity  in vivo  of oestradiol-17 β and whether this evidence came from a respected and qualified 
source.  For example, the Panel relies on the following opinion provided by Dr. Boobis: 
Dr. Boobis concluded that there is no good evidence that oestradiol is 
genotoxic in vivo  or that it causes cancer by a genotoxic mechanism.  
Indeed the evidence is against this .  Hence, the scientific evidence 
does not support the European Comm unities' position that the levels 
of the hormones in meat from treated cattle are not of relevance.1230 
608. Dr. Boisseau's response also goes beyond a verification of whether the European 
Communities' evidence on genotoxicity came from a respected and qualified source, into an 
examination of the general acceptance of the scien tific basis of the European Communities' risk 
assessment:   
In a review of the scientific literature and the 1999 report of the 
Committee for Veterinary Medicinal Products of the European 
Medicine Agency, Dr. Boisseau concluded that the demonstration 
remains to be made that the observed indicator effects are representative of mutagenesis at the gene or chromosome level and also occur in somatic cells  in vivo .  This is not likely in the view of 
the following:  earlier studies had mostly indicated that hormones do 
not induce micronuclei or other chromosomes aberration types  in 
vivo.  With the exception of the study reported by Dhillon and 
Dhillon, the recent data confirm the earlier findings and clearly indicate that hormones and/or their synthetic analogues are not associated with genotoxicity properties in the bone marrow 
micronucleas assay  in vivo.
1231 
609. At the same time, the Panel fails to expl ain how it reconciled its conclusion with the 
testimony of other experts that appear to ac knowledge that the European Communities' risk 
                                                      
1230Panel Report, US – Continued Suspension , para. 7.562; Panel Report, Canada – Continued 
Suspension , para. 7.530 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 184). 
1231Panel Report, US – Continued Suspension , para. 7.563; Panel Report, Canada – Continued 
Suspension , para. 7.531 (referring to replies of the scientific experts to questions posed by the Panel, Panel 
Reports, Annex D, para. 136). WT/DS321/AB/R 
Page 254  
 
assessment was based on evidence of genotoxicity  in vivo  of oestradiol-17 β.  In his written responses 
to questions by the Panel, Dr. Guttenplan referred  to a study, cited by the European Communities, 
allegedly indicating that the reactive metabolite oe stradiol-3, 4-quinone i nduces mutations in mice 
skin  in vivo .
1232  Dr. Guttenplan testified that "[t]he cate chol oestrogen-quinone form DNA adducts in 
cultured cells and in mouse skin", and concluded that "[t]his evidence was stronger compared to previous reports" , adding that "the  evidence now is much stronger."
1233  The Panel further explained, 
in the interim review, that it did "not read th is statement as implying that the residues of 
oestradiol-17 β in meat from treated cattle are definitely genotoxic".1234  The Panel added that, "even if 
this were the case, the issue of genotoxicity is only relevant to the issue of whether a threshold could 
be determined for this substance."1235  
610. We reiterate that the Panel was not called upon to determine whether there is general 
acceptance that oestradiol-17 β is genotoxic  in vivo  or that it causes cancer by a genotoxic 
mechanism.  Instead, the focus should have b een on the evidence relied upon by the European 
Communities in its risk assessment.  As we noted ear lier, the 1999 Opinion refers to several studies on 
the genotoxicity of oestradiol-17 β.1236  Additional studies are discussed in the 2002 Opinion.1237  
These studies should have been the focus of the Pane l's analysis, yet they are not mentioned in the 
Panel's analysis.  The Panel does not give any r easons why it did not consider them relevant.  
611. The European Communities' risk assessment also focused on the endogenous levels of 
hormones in pre-pubertal children and observed th at these levels were lower than previously 
thought.1238  Dr. Guttenplan seemed to accept the Euro pean Communities' position on this issue: 
Dr. Guttenplan found that the levels in meat could result in 
bioavailable oestrogen exceeding the daily production rate of 
oestradiol in pre-pubertal children.  "For pre-pubertal children, even 
with the low bioavailabilty of estroge n ... and its low levels in meats, 
it appears possible that intake leve ls would be within an order of 
magnitude of those of the daily produc tion rate.  This is greater than 
FDA's [(Food and Drug Administration of the United States)] ADI 
and suggests some risk to this population.  If there [are] genotoxic 
effects of estradiol in children, they may be reflected over a lifetime, as mutations arising from DNA damage are permanent.  It seems the more accurate methods of analysis could now be used to measure the 
effect of eating hormone-treated beef on blood levels of estrogen in 
                                                     
 
1232Replies of the scientific experts to questions posed by the Panel, Panel Reports, Annex D, para. 181. 
1233Ibid. 
1234Panel Report, US – Continued Suspension, para. 6.113;  Panel Report, Canada – Continued 
Suspension , para. 6.105. 
1235Ibid. 
12361999 Opinion, pp. 39-41. 
12372002 Opinion, pp. 13 and 14. 
12381999 Opinion, p. 38.   WT/DS321/AB/R 
 Page 255 
 
 
children and post-menopausal women.  If practical, this experiment 
would be important in establishing or refuting the arguments of the 
[European Communities]."1239  
The Panel does not address this statement furthe r nor does the Panel explain how Dr. Guttenplan's 
conclusion should be reconciled w ith the Panel's conclusion that the European Communities' risk 
assessment did not examine the specific risks arisi ng from the consumption of meat from cattle treated 
with oestradiol-17 β. 
612. We have identified above how the Panel appro ached its task without proper regard to the 
standard of review and the limitations this places upon the appraisal of expert testimony.  Ultimately, 
the Panel reviewed the scientific experts' opini ons and somewhat peremptorily decided what it 
considered to be the best science,  rather than following the more limited exercise that its mandate 
required.  In addition, the European Communities has drawn our attention to the following response 
provided by Dr. Guttenplan to the Panel's question on the specificity of th e European Communities' 
risk analysis: 
I believe the [European Communitie s] has done a thorough job in 
identifying the potential for adve rse effects on human health of 
oestradiol-17 β found in meat derived from cattle to which this 
hormone had been administered.  They have identified a number of 
potential adverse effects of oestradiol-17 β in humans.  They have 
established metabolic pathways relevant to these effects, and have examined mechanisms of these effe cts.  In addition they have 
performed thorough studies of resi due levels in cattle, and the 
environment.  The evidence eval uating the occurrence of adverse 
effects is weak.  Animal models are very limited and the target 
organs do not coincide well with th e target organs in humans.  There 
are basically no epidemiological studies comparing matched populations consuming meat from untreated and hormone-treated cattle.  Thus, little can be inferred about the potential occurrence of the adverse effects, the potential for adverse effects seems 
reasonable.
1240  
613. In his response, Dr. Guttenplan seems to re cognize that the European Communities' risk 
assessment did specifically examine the potential fo r adverse effects from the consumption of meat 
from cattle treated with oestradiol-17 β.  Dr. Guttenplan's response is summarized in the Panel's 
reasoning.1241  Yet, the Panel does not address that respon se any further.  Given that the European 
                                                      
1239Panel Report, US – Continued Suspension, para. 7.528;  Panel Report, Canada – Continued 
Suspension , para. 7.500 (quoting replies of the scientific experts to Question 52 posed by the Panel, Panel 
Reports, Annex D, para. 413. 
1240Replies of the scientific experts to questions posed by the Panel, Panel Reports, Annex D, 
para. 145). 
1241Panel Report, US – Continued Suspension , para. 7.523;  Panel Report, Canada – Continued 
Suspension , para. 7.495. WT/DS321/AB/R 
Page 256  
 
Communities was entitled to rely on minority views, the Panel was required to explain why it did not 
consider that Dr. Guttenplan's testimony s upported the European Communities' position. 
614. An additional flaw in the Panel's reasoning re lates to the following remark at the end of 
Panel's summary of the experts' responses: 
Additionally, in response to direct questioning during the Panel 
meeting with the experts, Drs. Boobis, Boisseau, and Guttenplan all agreed that there is no appreciable risk of cancer from residues of oestradiol-17 β in meat and meat products from cattle treated with the 
hormone for growth promotion purpo ses.  While all the experts who 
responded to the question agreed that a zero risk could not be guaranteed, the actual level of risk was in their view so small as to not be calculable.
1242 
It was not the Panel's task, much less that of the e xperts that the Panel consulted, to determine whether 
there is an appreciable risk of cancer arising fro m the consumption of meat from cattle treated with 
oestradiol-17 β.  Instead, the Panel was called upon to review the European Communities' risk 
assessment. 
615. The United States and Canada argue that the Pa nel properly exercised its discretion as the 
trier of facts.1243  We have found that the Panel did not appl y the proper standard of review.  This is a 
legal error and does not fall within the authority of th e Panel as the trier of facts.  Moreover, we have 
found instances in which the Panel exceeded its aut hority in the assessment of the testimony of the 
scientific experts.  By merely reproducing testim ony of some experts that would appear to be 
favourable to the European Communities' position,  without addressing its significance, the Panel 
effectively disregarded evidence that was potentially  relevant for the Europ ean Communities' case.  
This cannot be reconciled with the Panel's duty to ma ke an "objective assessment of the facts of the 
case" pursuant to Article 11 of the DSU.   
616. For these reasons, we find  that the Panel failed to conduct an  objective assessment of the facts 
of the case, as required by Article 11 of the DSU,  in determining whether the European Communities' 
risk assessment satisfied the requirements of Article 5.1 and Annex A of the  SPS Agreement .   
F. Conclusion 
617. We recall that we have found above that the Pane l erred in its interpreta tion and application of 
Article 5.1 in relation to risks of misuse and a buse in the administration of hormones to cattle for 
                                                      
1242Panel Report, US – Continued Suspension , para. 7.569;  Panel Report, Canada – Continued 
Suspension , para. 7.537 (referring to the transcript of the Panel meeting with the scientific experts, Panel 
Reports, Annex G, paras. 707-742).   
1243United States' appellee's submission, para. 47;  Canada's appellee's submission, para. 73.  WT/DS321/AB/R 
 Page 257 
 
 
growth-promoting purposes.  We have also found th at the Panel misallocated the burden of proof, and 
failed to conduct an objective assessment of the f acts, in its analysis of whether the European 
Communities' risk assessment met the requirements of Article 5.1 of the  SPS Agreement .  
618. In addition, we found earlier that the Panel has infringed the European Communities' due 
process rights by inappropriately relying on the testimony of Drs. Boisseau and Boobis in its evaluation of the consistency with Article 5.1 of the  SPS Agreement  of the European Communities' 
risk assessment relating to oestradiol-17 β.  Thus, the Panel's conclusions rest, to a large extent, on an 
improper evidentiary basis.   
619. Accordingly, we reverse
 the Panel's finding that the European Communities has not satisfied 
the requirements of Article 5.1 and Annex A, paragraph 4, of the  SPS Agreement .  As a consequence, 
we also reverse  the Panel's findings that Directive 2003/74/ EC was not based on a risk assessment 
within the meaning of Article 5.1 of the  SPS Agreement  and that the European Communities' 
"implementing measure on oestradiol-17 β is not compatible with Article 5.1 of the  SPS 
Agreement ."1244 
620. Having reversed the Panel, we must now determ ine whether we can complete the analysis by 
reviewing ourselves the consistency of the Europ ean Communities' risk assessment relating to 
oestradiol-17 β with Article 5.1 of the  SPS Agreement .  In the past, the Appellate Body has completed 
the analysis when there were sufficient factual fi ndings by the panel or undisputed facts on the Panel 
record to enable it to do so.1245  In light of the numerous flaws we have found in the Panel's analysis, 
and the highly contested nature of the facts, we do not  consider it possible to complete the analysis in 
this case.  Thus, we make no findings on the c onsistency or inconsistency of the European 
Communities' import ban relating to oestradiol-17 β. 
VII. The Consistency with Article 5.7 of the  SPS Agreement   of the European Communities' 
Provisional Import Ban on Meat from Cattle Treated with Testosterone, Progesterone, Trenbolone Acetate, Zeranol, an d MGA for Growth-Promotion Purposes 
A. Introduction 
621. We turn finally to the European Communities' a ppeal of the Panel's finding that the European 
Communities' provisional ban on meat from cattle treat ed with testosterone, progesterone, trenbolone 
acetate, zeranol, and MGA failed to meet the requirements of Article 5.7 of the  SPS Agreement  
because the relevant scientific evidence was not "insu fficient" within the meaning of that provision.  
                                                     
 
1244Panel Report, US – Continued Suspension , para. 7.579;  Panel Report, Canada – Continued 
Suspension , para. 7.549. 
1245Appellate Body Report, US – Section 211 Appropriations Act , para. 343. WT/DS321/AB/R 
Page 258  
 
Section B describes the conclusions of the European  Communities' evaluation of the potential adverse 
health effects of the five hormones, and section C summarizes the Panel's findings under Article 5.7 
of the  SPS Agreement.   Section D provides an overview of the claims and arguments raised on 
appeal.  In section E, we review the Panel's findings that the relevant scientific evidence in relation to 
the five hormones was not "insufficient" within the meaning of Article 5.7.  Our conclusions are set 
out in section F. 
B. The European Communities' Evaluation of the Five Hormones Subject to the 
Provisional Ban 
622. As we noted above
1246, following the adoption of the DSB's recommendations and rulings in  
EC – Hormones , the European Communities initiated 17 sci entific studies aimed at evaluating, inter 
alia, the potential for adverse effects to human health  from residues in bovine meat and meat products 
resulting from the use of oestradiol-17 β, testosterone, progesterone, zeranol, trenbolone acetate, and 
MGA.  The results of these studies, as well as other publicly available information, were reviewed by 
the SCVPH.  On 30 April 1999, the SCVPH issued the "1999 Opinion, in which it concluded that "in 
view of the intrinsic properties of hormones and ep idemiological findings, a risk to the consumer has 
been identified with different levels of conclu sive evidence for the six hormones in question."1247  As 
regards the five hormones, the 1999 Opinion further provided that "in spite of the individual toxicological and epidemiological data described in the report, the current state of knowledge did not allow a quantitative estimate of the risk."
1248  The European Communities concluded that "the 
currently available information for testosterone , progesterone and the synthetic hormones zeranol, 
trenbolone and particularly MGA has been consider ed inadequate to complete [a risk] assessment."1249  
The 1999 Opinion also states that "no final conclusions can be drawn with respect to the safety" of the 
five hormones.1250 
623. The SCVPH subsequently reviewed the 1999 Opinion in 2000 and 2002, in the light of 
additional scientific information it received, but di d not find it necessary to amend the conclusions 
originally reached in the 1999 Opinion.  The 2000  Opinion emphasized "the obvious gaps in the 
present knowledge on target animal metabolism and residue disposition of the hormones under
                                                      
1246See supra , sections I and IV.B.  
12471999 Opinion, p. 73.  
 1248Panel Report, US – Continued Suspension , para. 7.391 (quoting 1999 Opinion (Exhibit US-4 
submitted by the United States to the Panel), p. 73);  Panel Report, Canada – Continued Suspension , para. 7.388 
(quoting 1999 Opinion (Exhibit CDA-2 submitted by Canada to the Panel), p. 73).  The 1999 Opinion also 
concludes that "endocrine, developmental, immunological, neurobiological, immunotoxic, genotoxic and 
carcinogenic effects could be envisaged" for the five hormones, but "[i]n view of the intrinsic properties of the hormones and in consideration of epidemiological findings, no threshold levels could be defined". (See ibid.)  
12491999 Opinion, p. 75.  
1250Ibid.  WT/DS321/AB/R 
 Page 259 
 
 
consideration, including the synthetic hormones", and stated that it expected "that the on-going 
[European Communities'] research programs will  provide additional data on both topics".1251  
The 2002 Opinion arrived at the following specific conclusions in relation to potential risks arising 
from residues of the five hormones in bovine meat: 
(e) No new data regarding testos terone and progesterone relevant 
to bovine meat or meat products we re available.  However, it was 
emphasized that these natural hormones were used only in combination with oestradiol-17 β or other oestrogenic compounds in 
commercial preparations. 
(f)  Experiments with zeranol and trenbolone acetate suggested a 
more complex oxidative metabolism than previously assumed.  These data needed further clarificati on as they might influence a risk 
assessment related to tissu e residues of these compounds. 
(g)  Zeranol and trenbolone acetate had been tested for their 
mutagenic and genotoxic potential in various systems with different 
endpoints.  Both compounds exhibited only very weak effects. 
(h)  Data on the genotoxicity of [MGA] indicated only weak 
effects.  However, pro-apoptotic effects were noted in some cell-based assays, which were attribut ed to the impurities in commercial 
formulation.  Further experiment s should clarify the toxicological 
significance of these impurities.  
(i)  Model experiments with rabbits treated with zeranol, 
trenbolone acetate or [MGA], mirroring their use in bovines, were designed to study the consequences of  pre- and perinatal exposure to 
exogenous hormones.  All compounds crossed the placental barrier 
easily and influenced to varyi ng degrees the development of the 
foetus, at the doses used in the experiments.  
...  (k)  Several studies were devoted to the potential impact of the 
extensive use of hormones on the environment.  Convincing data 
were presented indicating the high stability of trenbolone acetate and 
[MGA] in the environment, whereas preliminary data were provided on the potential detrimental eff ects of hormonal compounds in 
surface water.
1252 
624. The European Communities enacted Dir ective 2003/74/EC, which provides for a  provisional  
ban on meat and meat products from cattle treated wi th progesterone, testosterone, zeranol, trenbolone 
                                                      
1251Panel Report, US – Continued Suspension , para. 7.392 (quoting 2000 Opinion (Exhibit US-17 
submitted by the United States to the Panel), p. 4);  Panel Report, Canada – Continued Suspension , para. 7.389 
(quoting 2000 Opinion (Exhibit CDA-4 submitted by Canada to the Panel), p. 4). 
1252Panel Report, US – Continued Suspension , para. 7.393 (quoting 2002 Opinion (Exhibit US-1 
submitted by the United States to the Panel), pp. 21 and 22);  Panel Report, Canada – Continued Suspension , 
para. 7.390 (quoting 2002 Opinion (Exhibit CDA-7 submitted by Canada to the Panel), pp. 21 and 22).  WT/DS321/AB/R 
Page 260  
 
acetate and MGA for growth-promotion purposes.  Before the Panel, the European Communities 
argued that the SCVPH Opinions and supporti ng studies provided the "available pertinent 
information" within the meaning of Article 5.7 on the basis of which the provisional ban on the five 
hormones had been enacted.
1253  
C. The Panel's Findings 
625. At the outset of its analysis, the Panel recalled its  earlier conclusion that the measure at issue, 
to the extent that it provisionally bans the importa tion of meat from cattle treated with the hormones 
progesterone, testosterone, zeranol, trenbolone acet ate, and MGA, is an SPS measure within the 
meaning of Article 1 and para graph 1 of Annex A to the  SPS Agreement .1254  The Panel, furthermore, 
observed that the "parties address the issue of the compatibility of the provisional ban on the above-
mentioned five hormones with the provisions of Article 5.7 of the  SPS Agreement " and that "[n]one 
... discussed the compatibility of the ban imposed with respect to these five hormones with 
Article 5.1".1255  Therefore, the Panel stated that it would "limit its review to the conformity of the 
[European Communities'] ban on the five hormones with the requirements of Article 5.7".1256 
626. Having identified Article 5.7 as the relevant provision, the Panel referred to the Appellate 
Body's interpretation of this provision as setting out  the following four cumulative requirements that 
must be satisfied in order to adopt an d maintain a provisional measure under the  SPS Agreement : 
(a) the measure is imposed in respect  to a situation where "relevant 
scientific evidence is insufficient"; 
(b) the measure is adopted "on the basis of available pertinent 
information"; 
(c) the WTO Member which adopted the measure must "seek to obtain 
the additional information necessar y for a more objective assessment 
of risk";  and 
                                                      
1253Panel Report, US – Continued Suspension , para. 7.581;  Panel Report, Canada – Continued 
Suspension , para. 7.551.   
1254Panel Report, US – Continued Suspension , para. 7.590;  Panel Report, Canada – Continued 
Suspension , para. 7.565. (footnote omitted) 
1255Panel Report, US – Continued Suspension , para. 7.591;  Panel Report, Canada – Continued 
Suspension , para. 7.566. (footnote omitted) 
1256Ibid.  WT/DS321/AB/R 
 Page 261 
 
 
(d) the Member which adopted the meas ure must "review the ... measure 
accordingly within a reasonable period of time".1257 
627. Turning to the first requirement, the Panel re ferred to the Appellate Body's statement in 
Japan – Apples  that scientific evidence will be insufficien t for purposes of Article 5.7 if the body of 
available scientific evidence does not allow, in qua ntitative or qualitative terms, the performance of an 
adequate risk assessment.1258  Recalling the approach it had adopted under Articles 5.1 and 5.2, the 
Panel dismissed the relevance of instances of mi suse or abuse and difficulties of control in the 
administration of the five hormones for the purpo ses of its determination of whether the relevant 
scientific evidence on the five horm ones was insufficient under Article 5.7.  The Panel reasoned that 
instances of misuse and abuse are not, as such, a sci entific issue likely to make a risk assessment 
impossible, and concluded that:   
In our opinion, the scientific issue is related to the effect of the 
ingestion of high doses of hormones residues, not to potential or 
actual misuse or abuse in the administration of hormones.  Therefore, 
we will not address the issue of non compliance with good veterinary 
practices in our analysis under Article 5.7 of the  SPS Agreement .1259 
628. The Panel then addressed the European Communitie s' argument that the appropriate level of 
protection is relevant for the purposes of de termining whether the scientific evidence is 
insufficient.1260  The Panel rejected the European Co mmunities' argument on the basis of the 
following reasoning: 
We note that sufficient scientific evid ence is what is needed to make 
a risk assessment.  The assessment  whether there is sufficient 
scientific evidence or not to perform  a risk assessment should be an 
objective process.  The level of protection defined by each Member may be relevant to determine the measure to be selected to address 
the assessed risk, but it should not influence the performance of the risk assessment as such. 
                                                     
 
1257Panel Report, US – Continued Suspension , para. 7.593;  Panel Report, Canada – Continued 
Suspension , para. 7.568 (quoting Appellate Body Report, Japan – Agricultural Products II , para. 89).   
1258Panel Report, US – Continued Suspension , para. 7.608;  Panel Report, Canada – Continued 
Suspension , para. 7.586. 
1259Panel Report, US – Continued Suspension , para. 7.603;  Panel Report, Canada – Continued 
Suspension , para. 7.578.  
1260The Panel described the European Communities' level of protection as: 
no (avoidable) risk, that is a level of protection that does not allow any 
unnecessary addition from exposure to genotoxic chemical substances that are 
intended to be added deliberately to food. 
(Panel Report, US – Continued Suspension , para. 7.607;  Panel Report, Canada – Continued Suspension , 
para. 7.585 (quoting replies of the European Communities to questions posed by the Panel after the second 
Panel meeting, Panel Reports, Annex C-1, para. 69)) WT/DS321/AB/R 
Page 262  
 
Indeed, whether a Member considers that its population should be exposed or not to a particular risk, or at what level, is not relevant to determining whether a risk exis ts and what its magnitude is. 
A fortiori , it should have no effect on whether there is sufficient 
evidence of the existence and magnitude of this risk. 
A risk-averse Member may be inc lined to take a protective position 
when considering the measure to be adopted.  However, the determination of whether scientific evidence is sufficient to assess the existence and magnitude of a ri sk must be disconnected from the 
intended level of protection.
1261 
629. The Panel next observed that the United Stat es and Canada argued that JECFA and several 
national regulatory bodies have determined that the scientific evidence regarding these hormones is 
adequate or sufficient to conduct a risk assessment.  The Panel, however, agreed with the parties that 
scientific evidence which was previously deemed to be sufficient could subsequently become 
insufficient.1262  On this basis, the Panel sought to dete rmine under what circumstances could relevant, 
previously sufficient, scientific evidence become insufficient within  the meaning of Article 5.7.  
630. Recalling the Appellate Body's decision in Japan – Apples , the Panel reasoned that 
"Article 5.7 will apply in situations where, in substance, the relevant scientific evidence does not 
allow the completion of an objective 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."1263  Also referring to the Appellate Body's decision in 
Japan – Apples , the Panel stated that "the existence of scientific uncertainty does not automatically 
amount to a situation of insufficiency of relevant scientific evidence".1264  The Panel added that, 
although it agreed that "under certain circumstance s what was previously sufficient evidence could 
become insufficient", it did not "believe that th e existence of scientific uncertainty means that 
previously sufficient evidence has in f act become insufficient nor should it  ipso facto  justify the 
applicability of Article 5.7 of the  SPS Agreement ".1265  
631. The Panel then turned to examine the relations hip between insufficiency of the evidence and
                                                      
1261Panel Report, US – Continued Suspension , paras. 7.610-7.612;  Panel Report, Canada – Continued 
Suspension , paras. 7.588-7.590. 
1262Panel Report, US – Continued Suspension , para. 7.620;  Panel Report, Canada – Continued 
Suspension , para. 7.598.  
1263Panel Report, US – Continued Suspension , para. 7.628;  Panel Report, Canada – Continued 
Suspension , para. 7.606 (referring to Appellate Body Report, Japan – Apples , para. 179).   
1264Panel Report, US – Continued Suspension , para. 7.631;  Panel Report, Canada – Continued 
Suspension , para. 7.609 (referring to Appellate Body Report, Japan – Apples , para. 184). 
1265Panel Report, US – Continued Suspension , para. 7.637;  Panel Report, Canada – Continued 
Suspension , para. 7.615.  In this respect, the Panel referred to the comments of Drs. Boisseau and Boobis on 
how scientific uncertainty is addresse d in risk assessment. (Panel Report, US – Continued Suspension , 
para. 7.635;  Panel Report, Canada – Continued Suspension , para. 7.613)  WT/DS321/AB/R 
 Page 263 
 
 
the existence of an international standard.  Accordin g to the Panel, "[t]he pr esumption of consistency 
of measures conforming to international standards,  guidelines and recommendations with the relevant 
provisions of the  SPS Agreement  implies that these standards, guidelines or recommendations, 
particularly those referred to in this case, are base d on risk assessments that meet the requirements of 
the  SPS Agreement ."1266  The Panel recognized that "science continuously evolves", and that it 
"cannot be excluded that new scientific evidence or  information calls into question existing evidence" 
or that "different risk assessments reach different  interpretations of the same scientific evidence".1267  
For the Panel, the existence of international sta ndards meant "that there was sufficient evidence for 
JECFA to undertake the appropriate risk assessments". 1268  The Panel added: 
As a result, we consider that, in order to properly take into account 
the existence of international standards, guidelines and recommendations in this case, our approach should be to assess whether scientific evidence has beco me insufficient by determining 
whether the European Communiti es has produced any evidence of 
some sufficient change in the scien tific knowledge so that what was 
once sufficient to perform an ad equate risk assessment has now 
become insufficient (i.e., "deficient in force, quality or amount").  In this respect, suggesting hypothetical  correlations or merely arguing 
that there could be more evidence on one concern or another should 
not be deemed sufficient to successfu lly claim that relevant scientific 
evidence has become insufficient .
1269  (original emphasis;  footnote 
omitted) 
632. The Panel concluded: 
... if relevant evidence already exis ts, not any degree of insufficiency 
will satisfy the criterion under Article 5.7 that "relevant scientific evidence is insufficient".  Having regard to our reasoning above, 
particularly with respect to scientif ic uncertainty and the existence of 
international standards, we cons ider that, depending on the existing 
relevant evidence, there must be a critical mass  of new evidence 
and/or information that calls into  question the fundamental precepts 
of previous knowledge and eviden ce so as to make relevant, 
previously sufficient, evidence now insufficient.  In the present case 
where risk assessments have been  performed and a large body of 
quality evidence has been accumulated, this would be possible only if it put into question existing relevant evidence to the point that  this 
evidence is no longer sufficient to support the conclusions of existing 
                                                     
 
1266Panel Report, US – Continued Suspension , para. 7.644;  Panel Report, Canada – Continued 
Suspension , para. 7.622. 
1267Panel Report, US – Continued Suspension , para. 7.645;  Panel Report, Canada – Continued 
Suspension , para. 7.623. 
1268Panel Report, US – Continued Suspension , para. 7.644;  Panel Report, Canada – Continued 
Suspension , para. 7.622. 
1269Panel Report, US – Continued Suspension , para. 7.647;  Panel Report, Canada – Continued 
Suspension , para. 7.625.  WT/DS321/AB/R 
Page 264  
 
risks assessments.  We therefore need  to determine whether this is the 
case here.
1270  (original emphasis;  footnote omitted) 
633. Next, the Panel sought to identify the alleged in sufficiencies in the scien tific evidence that it 
would have to address.  The Panel observed that, "[w] hereas, in application of the burden of proof in 
relation to Article 5.7 of the  SPS Agreement , it should be for the party challenging the applicability of 
Article 5.7 to make a  prima facie  case that the relevant scientif ic evidence regarding the five 
hormones is sufficient, it is also for the European Co mmunities, in application of the principle that it 
is for each party to prove its allegations, to sup port its own allegations w ith appropriate evidence."1271  
The Panel further noted that "even though in this  case the European Communitie s is the complainant, 
it also argues as part of its allegations under Artic le 22.8 of the DSU that its implementing measure 
complies with Article 5.7 of the  SPS Agreement ."1272  The Panel also recalled "the consequence of the 
presumption of consistency with the  SPS Agreement  and the GATT 1994 of measures which 
conform to international standards, guidelines a nd recommendations on the risk assessments on which 
such measures are based."1273  From this, the Panel reasoned that , "[s]ince, in that context, the 
European Communities argues that the relevant scientific  evidence is insufficient, we consider that it 
is for the European Communities to identify the issues for which such evidence is insufficient."1274  
Thus, the Panel did "not consider that, as Pa nel, we have any obligation to go beyond the 
insufficiencies identified by  the European Communities."1275 
634. Before turning to the alleged insufficiencies of the scientific evidence, however, the Panel 
noted that arguments and information presented to it were sometimes general and did not permit the 
Panel to address each insufficiency on a hormone-speci fic basis.  For this reason, the Panel decided to 
address separately, on the basis of the insufficien cies discussed and identified by the European 
Communities:  (i) the insufficiencies commonly identifie d for all of the five hormones at issue, "to the 
extent that information was not s ubmitted on a hormone-specific basis, or to the extent an issue was 
                                                      
1270Panel Report, US – Continued Suspension , para. 7.648;  Panel Report, Canada – Continued 
Suspension , para. 7.626. 
1271Panel Report, US – Continued Suspension , para. 7.652;  Panel Report, Canada – Continued 
Suspension , para. 7.629. (footnote omitted) 
1272Ibid.  
1273Ibid. 
1274Ibid. 
1275Panel Report, US – Continued Suspension , para. 7.653;  Panel Report, Canada – Continued 
Suspension , para. 7.630.  The Panel also stated its view "that it is incumbent upon a party making a particular 
allegation to identify in its submissions the relevance  of the evidence on which it relies to support its 
arguments".  (Panel Report, US – Continued Suspension , para. 7.658;  Panel Report, Canada – Continued 
Suspension , para. 7.635) (original emphasis)  The Panel observed that, "in light of its functions under the DSU, 
it should limit its review of alleged insufficiencies in the relevant scientific evidence to those specifically 
discussed by the European Communities in its submissions", and would "only address the issues identified in the Opinions to the extent they are sufficiently related to an issue  discussed  by the European Communities."  
(Panel Report, US – Continued Suspension , para. 7.659;  Panel Report, Canada – Continued Suspension , 
para. 7.636) (original emphasis)  WT/DS321/AB/R 
 Page 265 
 
 
raised with respect to all hormones, but ev idence submitted only for one or two of them"1276;  and 
(ii) the insufficiencies alleged for each hormone on th e basis of the information that was specific for 
that hormone. 
635. The Panel stated that the following insufficien cies in the relevant scientific evidence were 
identified and discussed by the Euro pean Communities in relation to all the five hormones at issue:  
(a) effects of hormones on certain categories of the population, such as pre-pubertal children;  (b) dose 
response;  (c) bioavailability;  (d) long latency period for cancer;  (e) the impact of the five hormones 
on the immune system;  and (f) the impact of the five hormones at issue on development and reproduction.
1277  
636. With regard to the effects of the hormones on certain categories of the population, the Panel 
referred to the conclusions in the European Communitie s' risk assessment that individuals that have 
the lowest endogenous levels of sex hormon es, particularly prepubescent children and post-
menopausal women, might be at an increased risk of  adverse health effects associated with exposure 
to exogenous sources of both o estrogens and testosterone.1278  The Panel noted that the European 
Communities' risk assessment made reference to th e development of new detection methods that had 
identified considerably lower levels of oestradi ol endogenously produced by pre-pubertal children 
than the levels previously identified using traditi onal detection methods.  The Panel also observed the 
European Communities' statement in the 1999 Opini on that "this is a critical area requiring additional 
study".1279 
637. The Panel recalled the "critical mass" sta ndard that it had developed to assess the 
insufficiency of the relevant scientific evidence under Article 5.7, and concluded that its task was to 
examine "whether the more sensitive detection me thods which identified lower hormonal levels in 
prepubertal children than thought until now are such  as to call into question the range of physiological 
levels of the sex hormones in humans currently believed to exist".1280 
                                                      
1276Panel Report, US – Continued Suspension , para. 7.661;  Panel Report, Canada – Continued 
Suspension , para. 7.638.  
1277Panel Report, US – Continued Suspension , para. 7.663;  Panel Report, Canada – Continued 
Suspension , para. 7.640.  The European Communities also referr ed to "misuse and abuse (unspecified implants, 
off-label use, black market drugs, etc." in its first submission to the Panel.  The Panel believed that this issue 
was not relevant to the insufficiency of the relevant scientific evidence under Article 5.7.  (Panel Report, US – 
Continued Suspension , footnote 787 to para. 7.654, and para. 7.483;  Panel Report, Canada – Continued 
Suspension , footnote 734 to para. 7.631) 
1278See Panel Report, US – Continued Suspension , para. 7.664;  and Panel Report, Canada – Continued 
Suspension , para. 7.641.  
1279Panel Report, US – Continued Suspension , para. 7.665;  Panel Report, Canada – Continued 
Suspension , para. 7.642. (footnote omitted) 
1280Panel Report, US – Continued Suspension , para. 7.666;  Panel Report, Canada – Continued 
Suspension , para. 7.643.  WT/DS321/AB/R 
Page 266  
 
638. The Panel concluded that:  
We note that the evidence presented relates only to oestradiol, but 
that the claim we are examining with  regard to the insufficiencies of 
the evidence are with respect to the five other hormones at issue, not 
oestradiol.  We note furthermore that the 2002 Opinion concludes that these more sensitive detection methods have not yet been validated. 
... we are not convinced that the studies discussed by the experts call 
into question the fundamental precepts of previous knowledge and evidence so as to make relevant, previously sufficient evidence now 
insufficient in relation to the effect of the five hormones on pre-pubertal children.  Particularly, it has not been established that the 
data regarding the effects of hormones on which the JECFA 
assessments are based are insufficient in light of new evidence relating to the other five hormones at issue.
1281  
639. Regarding dose response , the Panel noted that the European Communities questioned 
JECFA's findings on dose response, in the light of new detection methods that called into question 
previous knowledge about the e ndogenous production levels of hormones in pre-pubertal children.  
The Panel then observed that JECFA could identify a dose response for the five hormones at issue.  It 
also noted that the European Communities' argu ment was premised on the notion that endogenous 
production of natural hormones was lower than pr eviously thought, and recalled its previous 
conclusion that scientific studies in support of th is notion were not yet validated and applied 
exclusively to oestradiol.  The Panel found that "it has not been established that new evidence was 
such as to put into question existing data on dose response and prevent the performance of a risk 
assessment."1282 
640. With respect to bioavailability , the Panel observed that the new studies performed by the 
European Communities related exclusively to the bioavailability of oestradiol-17 β, and that it was 
unclear whether their findings would be re levant to hormones other than oestrogens.1283  The Panel 
then stated that "bioavailability would be an issue if the new evidence suggested that bioavailability in 
the case of ingestion of meat treated for grow th promotion purposes is higher than previously 
                                                      
1281Panel Report, US – Continued Suspension , paras. 7.670 and 7.671;  Panel Report, Canada – 
Continued Suspension , paras. 7.647 and 7.648.  
1282Panel Report, US – Continued Suspension , para. 7.675;  Panel Report, Canada – Continued 
Suspension , para. 7.652.  
1283Panel Report, US – Continued Suspension , para. 7.677;  Panel Report, Canada – Continued 
Suspension , para. 7.654 (referring to European Communities' second written submission to the Panel, paras. 123 
and 124).  These paragraphs describe excerpts contained in the 1999 and 2002 Opinions, which call into 
question NOEL (no-observed effect level) studies conducted by JECFA.  (See 1999 Opinion, pp. 36 and 37, 
and 2002 Opinion, p. 12)    WT/DS321/AB/R 
 Page 267 
 
 
thought."1284  However, the Panel noted that, in the ab sence of data, JECFA appears to have assumed 
100 per cent bioavailability.  The Panel referred to the testimony of Drs. Boisseau and Boobis, which 
confirmed that the bioavailability of the synthetic  hormones in humans has not been determined, and 
for this reason JECFA assumed 100 per cent bioavailability.1285  For these reasons, the Panel 
concluded that it was not established that "any new evidence on bioavailability has been developed 
regarding specifically the five hormones at issue,  which would affect the current knowledge on the 
subject."1286 
641. Regarding the long latency period1287 of cancer and confounding factors1288, the Panel noted 
the European Communities' allegation that "it may not be in a position to dem onstrate the existence of 
a clear harm in case of cancer because of the long latency period and the numerous confounding 
factors that play a role in the development of cancer."1289  The Panel then observed that Drs. Boobis, 
Cogliano, and Guttenplan agreed that it was importa nt to take account of the long latency period of 
cancer in conducting a risk assessment.1290  The Panel noted further Dr s. Boisseau's and Boobis' 
opinions that epidemiological studies, even if ta king into account long latency periods for cancer, 
might not be able to identify the specific agent that has caused the disease, by virtue of the many 
confounding factors.1291  In this respect, the Panel referred to Dr. Cogliano's statement that "it was 
generally possible to identify confounding factors in epidemiological studies" but it was often difficult 
to "determine whether the observed tumours can be attributed to the agent under study or to a confounding factor".
1292  The Panel observed that Drs. C ogliano, Guttenplan, and Boobis expressed 
the view that the epidemiological studies submitted by the European Communities did not establish a 
                                                      
1284Panel Report, US – Continued Suspension , para. 7.679;  Panel Report, Canada – Continued 
Suspension , para. 7.656.  
1285Panel Report, US – Continued Suspension , paras. 7.680 and 7.682;  Panel Report, Canada – 
Continued Suspension , para. 7.657 and 7.659 (quoting replies of the scientific experts to Question 43 posed by 
the Panel, Panel Reports, Annex D, paras. 347 and 351).   
1286Panel Report, US – Continued Suspension , para. 7.684;  Panel Report, Canada – Continued 
Suspension , para. 7.661.  
1287A "latency period" is the period between exposure  to an agent or process and the appearance of 
symptoms. ( Merriam-Webster Medical Dictionary  available at: <www.merriam-webster.com>)  
1288Confounding factors are factors other than the one investigated which may also correlate with the 
disease endpoint.  (Replies of the scientific experts to Question 24 posed by the Panel, Panel Reports, Annex D, 
para. 221) 
1289Panel Report, US – Continued Suspension , para. 7.685;  Panel Report, Canada – Continued 
Suspension , para. 7.662.  
1290Panel Report, US – Continued Suspension , paras. 7.687-7.690;  Panel Report, Canada – Continued 
Suspension , paras. 7.664-7.667 (quoting replies of the scien tific experts to Question 23 posed by the Panel, 
Panel Reports, Annex D, paras. 210, 213, and 214).  
1291Panel Report, US – Continued Suspension , paras. 7.691 and 7.692;  Panel Report, Canada – 
Continued Suspension , paras. 7.668 and 7.669 (quoting replies of the scientific experts to Question 23 posed by 
the Panel, Panel Reports, Annex D, paras. 209 and 211).  
1292Panel Report, US – Continued Suspension , para. 7.693;  Panel Report, Canada – Continued 
Suspension , para. 7.670 (quoting replies of the scientific experts to Question 24 posed by the Panel, Panel 
Reports, Annex D, para. 220).   WT/DS321/AB/R 
Page 268  
 
link or correlation between higher incidence of can cer and the consumption of residues of hormones 
in treated meat
1293, and found that:  
On the one hand, the comments of the experts suggest that 
epidemiological studies have not been able to single out residues of 
hormones in meat treated for growth promotion purposes as a cause 
of cancer, and that this would be difficult.  On the other hand, the Panel notes that it is possible to assess long term effects through long term studies of experimental animals, even if they involve much higher doses than would be encountered in consumption of meat 
from animals treated with growth promoting hormones.  It has also 
been possible to take into account th e risk attached to latency through 
the setting of ADI.  The European Communities has not identified any evidence quantitatively and qualita tively sufficient to call into 
question the fundamental precep ts of existing knowledge and 
evidence and the approach followed so far in order to integrate the 
long latency period of cancer in risk assessment.
1294 
642. Turning to the effects of the hormones on the immune system, the Panel noted the conclusion 
contained in the 1999 Opinion that there is insuffici ent evidence as to the effects of the hormones on 
the immune system.  The Panel rejected the Euro pean Communities' contention that it was for the 
responding parties to present evidence that adverse immune effects could not occur from residues of 
hormone-treated meat, because all the responding pa rties had to prove was their assertion that the 
relevant scientific evidence on these particular ri sks was sufficient to perform an adequate risk 
assessment.1295  Next, the Panel observed that the experts identified potential adverse effects on the 
immune system arising exclusively from oestrogens1296, and that there was no evidence to suggest that 
those risks could not be addressed  through a dose-response approach.1297  The Panel also concluded 
that the 1999 Opinion itself does not provide evidence of impact of any of the five hormones on the immune system.
1298  For these reasons, the Panel found that "i t is not established that there exists a 
critical mass of new evidence and/or information that  calls into question the fundamental precepts of 
                                                      
1293Panel Report, US – Continued Suspension , paras. 7.695-7.697;  Panel Report, Canada – Continued 
Suspension , paras. 7.672-7.674 (quoting replies of the scien tific experts to Question 26 posed by the Panel, 
Panel Reports, Annex D, paras. 241, 242, and 239).   
1294Panel Report, US – Continued Suspension , para. 7.699;  Panel Report, Canada – Continued 
Suspension , para. 7.676.  
1295Panel Report, US – Continued Suspension , para. 7.705;  Panel Report, Canada – Continued 
Suspension , para. 7.682. 
1296Panel Report, US – Continued Suspension , para. 7.706;  Panel Report, Canada – Continued 
Suspension , para. 7.683. 
1297Panel Report, US – Continued Suspension , para. 7.707;  Panel Report, Canada – Continued 
Suspension , para. 7.684.  
1298Panel Report, US – Continued Suspension , para. 7.706;  Panel Report, Canada – Continued 
Suspension , para. 7.683 (referring to 1999 Opinion, pp. 51, 55, 60, and 66).   WT/DS321/AB/R 
 Page 269 
 
 
previous knowledge and evidence so as to make re levant, previously sufficient, evidence on hormone 
effects on the immune system now insufficient."1299 
643. Finally, as regards the effects on growth and reproduction , the Panel initially observed that 
the European Communities had advanc ed no specific argument in relation to the insufficiency of the 
evidence of adverse effects of the five hormones on growth and reproduction.  Nevertheless, the Panel 
decided to address this issue in light of the Eu ropean Communities' contention that the new data 
revealed "important gaps, insu fficiencies and contradictions"1300 in the relevant scientific evidence.  
The Panel observed that Dr. Guttenplan initially identi fied a number of gaps in the scientific evidence 
that could relate to growth and reproduction, but subsequently declared that it was possible to conduct 
a risk assessment of the five hormones.1301  Dr. Boobis, in turn, expressed the view that the scientific 
studies do not "support the contention that they have  identified important ne w gaps, insufficiencies 
and contradictions in the scientific information" and that additional information obtained "was often 
not definitive, sometimes it was not relevant, in some instances it confirmed or expanded on previous 
knowledge".1302  Next, the Panel dismissed the opinions of Drs. Sippell and Guttenplan about 
potential developmental effects of hormones in chil dren on the basis that these statements reflected 
"doubts" but did not constitute "evidence of risks".1303  Finally, the Panel cons idered that the evidence 
referred to by the European Commun ities related only to oestradiol-17 β, and that the European 
Communities had not substantiated its assertion that  the scientific evidence  was insufficient to 
conduct a risk assessment with respect to the other five  hormones.  On this basis, the Panel concluded 
that "it has not been estab lished that there is a critical mass of new evidence ... so as to make relevant, 
previously sufficient evidence now insufficient in relation to the growth and reproduction effects".1304  
644. Next, the Panel turned to the sp ecific insufficiencies alleged in relation to each of the five 
hormones individually.   
645. In relation to progesterone, the Panel focused  on the European Communities' allegation that
                                                      
1299Panel Report, US – Continued Suspension , para. 7.708;  Panel Report, Canada – Continued 
Suspension , para. 7.685.  
1300Panel Report, US – Continued Suspension , para. 7.709;  Panel Report, Canada – Continued 
Suspension , para. 7.686.  
1301Panel Report, US – Continued Suspension , para. 7.710;  Panel Report, Canada – Continued 
Suspension , para. 7.687. 
1302Panel Report, US – Continued Suspension , para. 7.711;  Panel Report, Canada – Continued 
Suspension , para. 7.688 (quoting replies of the scientific experts to Question 62 posed by the Panel, Panel 
Reports, Annex D, para. 495). 
1303Panel Report, US – Continued Suspension , para. 7.719;  Panel Report, Canada – Continued 
Suspension , para. 7.696 (quoting transcript of the Panel's joint meeting with scientific experts 
on 27-28 September 2006, Panel Reports, Annex G, paras. 1061 and 1063).  
1304Panel Report, US – Continued Suspension , para. 7.721;  Panel Report, Canada – Continued 
Suspension , para. 7.698.  WT/DS321/AB/R 
Page 270  
 
the relevant scientific evidence on carcinogenic or genotoxic potential of this hormone was 
insufficient, because the other in sufficiencies identified by the Eu ropean Communities had already 
been addressed by the Panel in its analysis of  the insufficiencies common to the five hormones.
1305  
The Panel noted that the 2002 Opinion concluded that  "[t]here is no evidence that progesterone or 
testosterone have genotoxic potential".1306  The Panel observed that Drs. Boisseau, Boobis, and 
Guttenplan agreed that there w as no evidence that progesterone was genotoxic.  The Panel also 
referred to Dr. Boisseau's opinion that the sci entific evidence submitte d by the European 
Communities did not support the conclusion that carci nogenic effects of progesterone are related to a 
mechanism other than hormonal activity.1307  The Panel noted further that IARC opinions had not 
evaluated the carcinogenicity of residues of progesterone in beef, and quoted the opinions of Drs. Boobis and Guttenplan that the relevant scien tific evidence on progesterone was sufficient to 
conduct a risk assessment.
1308  The Panel concluded that it had not  been established that the relevant 
scientific evidence with respect to progesterone was insufficient within the meaning of Article 5.7 of 
the  SPS Agreement . 
646. Turning to testosterone, the Panel noted that many of the insufficiencies in the relevant 
scientific evidence had been addressed in  common with the other four hormones.1309  The Panel's 
analysis therefore focused on the evidence of genot oxicity and carcinogenicity of testosterone.  The 
Panel observed that the 1999 Opinion stated that  no information was available on DNA damage 
induced by testosterone or its metabolites, a nd that "[w]hereas the evidence in favour of 
carcinogenicity was considered sufficient for testoster one in experimental animals, data in humans are 
limited".1310  According to the Panel, this statement had to be read in conjunction with the conclusion 
that "the evidence regarding the role of testos terone in prostate cancer is currently weak".1311  In the 
Panel's view, this evidence did not meet the "cr itical mass" test that it articulated to assess 
insufficiency within the meaning of Article 5.7.   The Panel noted, moreover, Dr. Boisseau's opinion 
that the scientific evidence submitted by the Eur opean Communities did not support the conclusion 
                                                      
1305Panel Report, US – Continued Suspension , para. 7.729;  Panel Report, Canada – Continued 
Suspension , para. 7.706. 
1306Panel Report, US – Continued Suspension , para. 7.731;  Panel Report, Canada – Continued 
Suspension , para. 7.708 (quoting 2002 Opinion, section 4.3, p. 15).   
1307Panel Report, US – Continued Suspension , paras. 7.738;  Panel Report, Canada – Continued 
Suspension , para. 7.715 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 158).  
1308Panel Report, US – Continued Suspension , paras. 7.740 and 7.741;  Panel Report, Canada – 
Continued Suspension , paras. 7.717 and 7.718.  
1309Panel Report, US – Continued Suspension , para. 7.746;  Panel Report, Canada – Continued 
Suspension , para. 7.726. 
1310Panel Report, US – Continued Suspension , para. 7.749;  Panel Report, Canada – Continued 
Suspension , para. 7.729 (quoting 1999 Opinion, p. 49).   
1311Panel Report, US – Continued Suspension , para. 7.749;  Panel Report, Canada – Continued 
Suspension , para. 7.729.   WT/DS321/AB/R 
 Page 271 
 
 
that carcinogenic effects of testosterone are rela ted to a mechanism other than hormonal activity.1312  
The Panel therefore found that it had not been estab lished that the relevant scientific evidence with 
respect to testosterone was insufficient within the meaning of Article 5.7 of the  SPS Agreement . 
647. The Panel limited its analysis concerning trenbolone acetate  to two distinct "insufficiencies" 
that were identified by the European Communities in  the scientific evidence:  (i) the metabolism of 
trenbolone acetate;  and (ii) inadequate evidence of carcinogenicity in humans.1313  Regarding the 
metabolism of trenbolone, the Panel contrasted th e statement in the 2002 Opinion that "experiments 
with ... trenbolone acetate suggested a more complex oxidative metabolism than previously assumed"
1314 with Dr. Boobis' opinion that "these data do not affect the risk assessment of trenbolone 
acetate."1315  In relation to the evidence on carcinogeni city of trenbolone, the Panel referred to 
Dr. Boobis' opinion that "[t]hese data are insuffi cient ... to alter the conclusion that ... trenbolone 
acetate has genotoxic potential in vivo"1316;  Dr. Guttenplan's view that "[t]renbolone is either negative 
or marginally active in  in vitro  genotoxic assays"1317;  and Dr. Boisseau's statement that "the 
scientific evidence relied upon in the SCVPH Opinions does not support the conclusion that the carcinogenic effects of trenbolone are related to  a mechanism other than hormonal activity."
1318  The 
Panel also noted Dr. Boobis' opinion that the info rmation available was sufficient for the European 
Communities to conduct a risk assessment in relation to the six hormones.  In addition, the Panel 
observed that, although Dr. Guttenplan stated that no "accurate ADIs can be established [for trenbolone] at this point"
1319, he later clarified that this "does not mean that you can't make a risk 
                                                      
1312Panel Report, US – Continued Suspension , paras. 7.752;  Panel Report, Canada – Continued 
Suspension , para. 7.732 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 160).  
1313Panel Report, US – Continued Suspension , para. 7.761;  Panel Report, Canada – Continued 
Suspension , para. 7.743. 
1314Panel Report, US – Continued Suspension , para. 7.762;  Panel Report, Canada – Continued 
Suspension , para. 7.744 (quoting 2002 Opinion, section 7, p. 21).  
1315Panel Report, US – Continued Suspension , para. 7.763;  Panel Report, Canada – Continued 
Suspension , para. 7.745 (quoting replies of the scientific experts to Question 62 posed by the Panel, Panel 
Reports, Annex D, para. 480).  
1316Panel Report, US – Continued Suspension , para. 7.770;  Panel Report, Canada – Continued 
Suspension , para. 7.752 (quoting replies of the scientific experts to Question 62 posed by the Panel, Panel 
Reports, Annex D, para. 483).  
1317Panel Report, US – Continued Suspension , para. 7.771;  Panel Report, Canada – Continued 
Suspension , para. 7.753 (quoting replies of the scientific experts to Question 21 posed by the Panel, Panel 
Reports, Annex D, para. 200).  
1318Panel Report, US – Continued Suspension , para. 7.775;  Panel Report, Canada – Continued 
Suspension , para. 7.757 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 164).  
1319Panel Report, US – Continued Suspension , para. 7.779;  Panel Report, Canada – Continued 
Suspension , para. 7.761 (quoting replies of the scientific experts to Question 61 posed by the Panel, Panel 
Reports, Annex D, para. 457).  WT/DS321/AB/R 
Page 272  
 
assessment, it just means that the accuracy  of the risk assessment is different."
1320  Thus, the Panel 
concluded that the relevant scientific evidence on trenbolone was not insufficient within the meaning 
of Article 5.7.  
648. As regards zeranol, the Panel began by reca lling the 1999 Opinion's conclusion that the 
scientific evidence "gave equivocal results insufficient for an evaluation of the mutagenic/genotoxic 
properties of zeranol" and that, as far as carcinogenici ty of zeranol was concerned, "there is clear 
evidence for the induction of liver adenomas and car cinomas in one animal species, but no assessment 
of the possible carcinogenicity of zeranol can be made."1321  The Panel then analyzed the views 
expressed by the experts on the scientific evidence relating to the mutagenic, genotoxic and carcinogenic properties of zeranol, in particular Dr. Boisseau's remark that JECFA "concluded that the 'tumorigenic effect of zeranol was associated with its oestrogenic properties'"
1322 and the statement in 
the 2002 Opinion that an  in vitro  study of zeranol in which it "did not induce genotoxicity or 
mutagenicity."1323  Dr. Sippell opined that zeranol and its metabolites "have been shown to be as 
potent as [oestradiol] ... in increasing the expression of  estrogen-related genes in human breast cancer 
cells."1324  However, referring to the same  evidence, Dr. Boobis noted that  in vitro   studies have 
limited relevance "to the situation  in vivo , where kinetic and metabolic factors will influence the 
magnitude of the response".1325  Therefore, according to Dr. Boobis, "[t]hese data are insufficient to 
support the conclusion that these hormones have genotoxic potential in vivo."1326  Dr. Guttenplan also 
noted that "[z]eranol can induce transformation of breast epithelial cells in culture with efficiency 
similar to that of oestradiol, but the mechanism is  now known, and it is negative or marginally active 
in other assays."1327  Dr. Boisseau opined that "the scientific evidence relied upon in the SCVPH
                                                      
1320Panel Report, US – Continued Suspension , para. 7.780;  Panel Report, Canada – Continued 
Suspension , para. 7.762 (quoting transcript of the Panel's joint meeting with scientific experts 
on 27-28 September 2006, Panel Reports, Annex G, para. 983).  
1321Panel Report, US – Continued Suspension , para. 7.788;  Panel Report, Canada – Continued 
Suspension , para. 7.772 (referring to 1999 Opinion, sections 4.5.5 to 4.5.7, pp. 64 and 65).  
1322Panel Report, US – Continued Suspension , para. 7.790;  Panel Report, Canada – Continued 
Suspension , para. 7.774 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 165).  
1323Panel Report, US – Continued Suspension , para. 7.791;  Panel Report, Canada – Continued 
Suspension , para. 7.775 (quoting 2002 Opinion, section 4.4.3, p. 16).  
1324Panel Report, US – Continued Suspension , para. 7.792;  Panel Report, Canada – Continued 
Suspension , para. 7.776 (quoting replies of the scientific experts to Question 41 posed by the Panel, Panel 
Reports, Annex D, para. 336).   
1325Ibid. (quoting replies of the scientific experts to Question 62 posed by the Panel, Panel Reports, 
Annex D, para. 475). 
1326Panel Report, US – Continued Suspension , para. 7.793;  Panel Report, Canada – Continued 
Suspension , para. 7.777 (quoting replies of the scientific experts to Question 21 posed by the Panel, Panel 
Reports, Annex D, para. 198).   
1327Panel Report, US – Continued Suspension , para. 7.795;  Panel Report, Canada – Continued 
Suspension , para. 7.779 (quoting replies of the scientific experts to Question 21 posed by the Panel, Panel 
Reports, Annex D, para. 200).    WT/DS321/AB/R 
 Page 273 
 
 
Opinions does not support the conclusion that the carcinogenic effects of zeranol are related to a 
mechanism other than hormonal activity."1328  Finally, the Panel also referred to Dr. Guttenplan's 
opinion that a more recent study suggested a risk  from zeranol, but "the results were obtained in 
cultured cells and the relevance to human exposure to  hormone-treated [meat] cannot be extrapolated 
from this study because of a myriad of uncertainties in such extrapolation.  The study does suggest 
that additional tests of zeranol should be carried out."1329  On this basis, the Panel concluded that "it is 
not established that relevant scientific evidence is insufficient in relation to the carcinogenicity of 
zeranol, within the meaning of Article 5.7 of the  SPS Agreement ."1330 
649. Finally, in relation to MGA, the Panel focused  on two distinct "insufficiencies" in the 
scientific evidence:  (i) whether only limited data we re available on residues of MGA in treated cattle;  
and (ii) whether the evidence for carcinogeni city of MGA in humans was inadequate.1331  As a 
preliminary remark, however, the Panel noted that no international standards for MGA existed, but 
"intensive work" had been performed on MGA at the international level, particularly two risk 
assessments by JECFA.1332  The Panel observed that MGA was on Codex's priority list for 
recalculation of Maximum Residue Levels ("MRLs"), and that the draft MRL for MGA was at Step 7 
of the Codex elaboration procedure.  The Panel stated that "the role of JECFA in the international risk 
assessment process is such that  some degree of relevance should be given to that work"1333, and, on 
this basis, concluded that the existence of assessme nts by JECFA "suggests that  evidence has been at 
one point sufficient."1334 
650. As for the data on residues of MGA, whic h the European Communities suggested were 
outdated, the Panel noted that both Drs. Boisseau a nd De Brabander recognized that nearly all studies 
used by JECFA dated back to th e 1960s and 1970s.  Neither of them, however, stated that those 
studies were no longer valid.  The Panel also recalled its  earlier conclusion that the fact that a study is 
                                                      
1328Panel Report, US – Continued Suspension , para. 7.796;  Panel Report, Canada – Continued 
Suspension , para. 7.780 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 166).   
1329Panel Report, US – Continued Suspension , para. 7.797;  Panel Report, Canada – Continued 
Suspension , para. 7.781 (quoting replies of the scientific experts to Question 25 posed by the Panel, Panel 
Reports, Annex D, para. 234).   
1330Panel Report, US – Continued Suspension , para. 7.800;  Panel Report, Canada – Continued 
Suspension , para. 7.784. 
1331Panel Report, US – Continued Suspension , para. 7.812;  Panel Report, Canada – Continued 
Suspension , para. 7.798.  
1332Panel Report, US – Continued Suspension , para. 7.806;  Panel Report, Canada – Continued 
Suspension , para. 7.799. 
1333Panel Report, US – Continued Suspension , para. 7.813;  Panel Report, Canada – Continued 
Suspension , para. 7.799.  
1334Panel Report, US – Continued Suspension , para. 7.827;  Panel Report, Canada – Continued 
Suspension , para. 7.813.  WT/DS321/AB/R 
Page 274  
 
old does not per se  put in doubt the validity of the study.
1335  The Panel, furthermore, quoted opinions 
by Drs. Boisseau and Boobis to the effect that new scientific studies did not undermine the MRLs for 
MGA calculated by JECFA, because the latter were based on very conservative assumptions.1336 
651. Turning to the evidence on the carcinogenicity in  humans of MGA, the Panel noted that the 
statement in the 2002 Opinion that "[t]he results [f or genotoxicity of MGA] were negative in several 
experiments"1337 seemed to confirm JECFA's conclusions.  The Panel also made reference to 
Dr. Boobis' opinion that "[MGA was] negative in a range of tests for genotoxicity"1338, and 
Dr. Guttenplan's statement that "MGA is negative in genotoxic assays".1339  On the potential 
carcinogenicity of MGA, the Panel stressed that IARC has not assessed the specific risks of cancer 
arising from the consumption of meat treated with MGA, and recalled Dr. Boisseau's view that "the 
scientific evidence relied upon in the SCVPH Opinions does not support the conclusion that the 
carcinogenic effects of [MGA] are related to  a mechanism other than hormonal activity."1340  The 
Panel also referred to Dr. Boobis' opinion that  the evidence was sufficient to conduct a risk 
assessment in relation to all six hormones at issue,  and Dr. Guttenplan's statements that "[JECFA's] 
assessment for [MGA] seems sound" and that "[t] horough metabolic and estrogenic studies have been 
carried out."1341  The Panel concluded that the relevant evidence for MGA was not  insufficient within 
the meaning of Article 5.7.1342   
652. At the end of its analysis, the Panel said that  it had asked the scientific experts whether the 
scientific evidence relied upon by the European Communities supported the European Communities' 
contention that the scientific studies initiated since 1997 had identified new important gaps, 
insufficiencies and contradictions in the scien tific information and knowledge available on these 
                                                      
1335Panel Report, US – Continued Suspension , para. 7.816 (referring to ibid., para. 7.423 et seq .);  Panel 
Report, Canada – Continued Suspension , para. 7.802 (referring to ibid., paras. 7.414 et seq .). 
1336Panel Report, US – Continued Suspension , paras. 7.817 and 7.818;  Panel Report, Canada – 
Continued Suspension , para. 7.803 and 7.804 (quoting replies of the scientific experts to Panel Questions 35 and 
62, Panel Reports, Annex D, paras. 303 and 484).   
1337Panel Report, US – Continued Suspension , para. 7.820;  Panel Report, Canada – Continued 
Suspension , para. 7.806 (quoting 2002 Opinion, section 4.5.3, p. 18).  
1338Panel Report, US – Continued Suspension , para. 7.822;  Panel Report, Canada – Continued 
Suspension , para. 7.808 (quoting replies of the scientific experts to Question 21 posed by the Panel, Panel 
Reports, Annex D, para. 198).  
1339Panel Report, US – Continued Suspension , para. 7.823;  Panel Report, Canada – Continued 
Suspension , para. 7.809 (quoting replies of the scientific experts to Question 21 posed by the Panel, Panel 
Reports, Annex D, para. 200).  
1340Panel Report, US – Continued Suspension , para. 7.826;  Panel Report, Canada – Continued 
Suspension , para. 7.812 (quoting replies of the scientific experts to Question 16 posed by the Panel, Panel 
Reports, Annex D, para. 162). 
1341Panel Report, US – Continued Suspension , para. 7.829;  Panel Report, Canada – Continued 
Suspension , para. 7.815 (quoting replies of the scientific experts to Question 61 posed by the Panel, Panel 
Reports, Annex D, para. 458).  
1342Panel Report, US – Continued Suspension , para. 7.830;  Panel Report, Canada – Continued 
Suspension , para. 7.816.  WT/DS321/AB/R 
 Page 275 
 
 
hormones such that more scientific studies are nec essary before the risk to human health from the 
consumption of meat from cattle treated with these hormones for growth-p romotion purposes can be 
assessed.  The Panel recalled its test that there mu st be a critical mass of new evidence and/or 
information that calls into question the fundament al precepts of previous knowledge and evidence so 
as to make relevant, previously sufficient eviden ce now insufficient and noted that the experts who 
expressed themselves in detail on this matter confir med, both in general and for each of the five 
hormones subject to a provisional ban, that  such critical mass had not been reached.1343 
653. Thus, the Panel found: 
For all these reasons, we conclude that it has not been demonstrated 
that relevant scientific evidence w as insufficient, within the meaning 
of Article 5.7 of the SPS Agreement , in relation to any of the five 
hormones with respect to which th e European Communities applies a 
provisional ban.1344 
654. Having made this finding, the Panel recalled that the four requirements outlined by the 
Appellate Body in Japan – Agricultural Products II applied cumulatively.1345  The Panel added that, 
"[s]ince we found that the first requirement (the me asure is imposed in respect to a situation where 
'relevant scientific evidence is in sufficient') has not been satisfied, we do not find it necessary to 
address any of the three other requirements."1346  The Panel concluded: 
We therefore conclude that the [European Communities'] compliance 
measure does not meet the require ments of Article 5.7 of the 
SPS Agreement  as far as the provisional ban on progesterone, 
testosterone, zeranol, trenbolone acetate and melengestrol acetate is concerned.
 1347 
655. After setting out its conclusion, the Panel made the following clarification of its implications: 
Having reached that conclusion, we want to make clear that we only 
determined that it had not been est ablished that the existing relevant 
scientific evidence was insufficient.   This does not mean that no 
measure can be imposed by the European Communities under the SPS Agreement  in relation to the five horm ones at issue.  Indeed, our 
determinations are without prejudice to the legality of any [European 
Communities'] measure regardi ng these hormones, should the 
                                                     
 
1343Panel Report, US – Continued Suspension , para. 7.834;  Panel Report, Canada – Continued 
Suspension , para. 7.820.  
1344Panel Report, US – Continued Suspension , para. 7.835;  Panel Report, Canada – Continued 
Suspension , para. 7.821. 
1345Panel Report, US – Continued Suspension , para. 7.836;  Panel Report, Canada – Continued 
Suspension , para. 7.822. 
1346Ibid. 
1347Ibid. WT/DS321/AB/R 
Page 276  
 
European Communities decide to complete its risk assessments 
pursuant to Article 5.1 of the SPS Agreement .
1348  
D. Claims and Arguments on Appeal 
656. The European Communities claims that the Panel erred in finding that the relevant scientific 
evidence on the five hormones was not "insufficient"  within the meaning of Article 5.7 of the  SPS 
Agreement  and that, consequently, the provisional ban on the importation and marketing of meat 
from cattle treated with the five hormones does not meet the requirements of that provision.   
657. First, the European Communiti es argues that the Panel erred in finding that the European 
Communities' chosen level of protection was not relevant for the determination of whether the 
relevant scientific evidence on the five hormones was "i nsufficient" within the meaning of Article 5.7.  
The European Communities emphasizes that Article 3.3 of the  SPS Agreement  permits it to adopt 
SPS measures that result in a higher level of prot ection than the one "implie[d] or encapsulate[d]"1349 
in the relevant international standards, and for th is reason its intended leve l of protection must be 
relevant for determining whether the scientific ev idence is "insufficient" within the meaning of 
Article 5.7.   
658. Secondly, the European Communities challenges the Panel's finding that the presumption of 
consistency that applies under Article 3.2 of the  SPS Agreement  to measures that conform to 
international standards "implies that these standa rds ... are based on risk assessments that meet the 
requirements of the  SPS Agreement " and that therefore "there was sufficient evidence for JECFA to 
undertake the appropriate risk assessments."1350  According to the European Communities, the 
presumption that applies to measures that confor m to international standards does not necessarily 
mean that the international standards themselves ar e based on a risk assessment within the meaning of 
Article 5.1 because the international standard may not be based on a risk assessment, or it may be 
based on an assessment that takes into account diffe rent factors or outdated scientific opinions. 
659. Thirdly, the European Communiti es argues that the Panel erred in allocating to the European 
Communities the burden of demonstrating that the provisional ban on meat and meat products treated 
with the five hormones met the requirements of Article 5.7 of the  SPS Agreement.  In doing so, the 
Panel erroneously interpreted Ar ticle 5.7 to be an exception to Article 5.1.  The European 
Communities maintains that Article 5.7 confers on WTO Members a "qualified right"1351 to take 
                                                      
1348Panel Report, US – Continued Suspension , para. 7.837;  Panel Report, Canada – Continued 
Suspension , para. 7.823. 
1349European Communities' appellant's submission, para. 397.  
1350European Communities' appellant's submission, para. 387 (quoting Panel Report, US – Continued 
Suspension , para. 7.644;  and Panel Report, Canada – Continued Suspension , para. 7.622).    
1351European Communities' appellant's submission, para. 368.    WT/DS321/AB/R 
 Page 277 
 
 
provisional SPS measures in cases where they consid er that the relevant scientific evidence is 
insufficient.  Therefore, the United States and Ca nada bore the burden of demonstrating that this 
condition had not been fulfilled by the European Communities.  The Europ ean Communities asserts 
that the Panel mistakenly shifted the burden of pr oof under Article  5.7 to the European Communities 
by limiting its review exclusively to the "insufficien cies" in the scientific evid ence that were identified 
by the European Communities in its submissions.1352 
660. Fourthly, the European Commun ities argues that the Panel erred in finding that, where 
international standards for a substance exist, a "critic al mass" of new scientific evidence that calls into 
question the fundamental precepts of previous knowle dge is required to render the relevant scientific 
evidence "insufficient" within the meaning of Article 5.7.1353  The European Communities suggests 
that, if a Member may legitimately follow a "resp ectable minority view" in its risk assessment, "it 
must be incorrect and entirely disproportionate to exclude  a priori  that a respectable minority could 
not make the available scien tific evidence insufficient."1354  Thus, the Panel's "critical mass" standard 
imposed an excessively "high qu antitative and qualitative threshold"1355 with respect to the new 
scientific evidence that is required to render the rele vant scientific evidence insufficient.  According to 
the European Communities, the quality of the scientific  evidence is more important that the quantity, 
and even a single study made by qualifie d and respectable scientists could be  a priori  sufficient to 
conclude that the scientific relevant scientific ev idence is insufficient, provided that its merits are 
particularly relevant for the circumstances of the risk assessment.1356  The European Communities 
also submits that the Panel's "critical mass" st andard effectively "preclude[d] [the] application"1357 of 
the precautionary principle in the interpretation of  Articles 5.1 and 5.7, because it implies that the 
relevant scientific evidence passes immediately from a state of insufficiency under Article 5.7 to a 
state of complete knowledge under Article 5.1; there will be no transitional period in which 
Article 5.7 could apply.1358  Furthermore, the European Communities submits that the application of 
the "critical mass" standard led the Panel to "ignore highly relevant scientific evidence"1359, which 
demonstrated that the relevant scientific eviden ce was insufficient to perform a risk assessment.  
According to the European Commun ities, the relevant scientific evid ence was insufficient to perform 
a risk assessment in the areas of: (i) effects of  hormones on certain population groups;  (ii) dose 
                                                      
1352European Communities' appellant's submissi on, para. 380 (referring to Panel Report, US – 
Continued Suspension , para. 7.653;  and Panel Report, Canada – Continued Suspension , para. 7.630).  
1353Ibid., para. 409 (quoting Panel Report, US – Continued Suspension , para. 7.648;  and Panel Report, 
Canada – Continued Suspension , para. 7.626). 
1354Ibid., para. 409.  
1355Ibid., para. 412.  
1356Ibid., para. 413. 
1357Ibid., para. 427.  
1358European Communities' statement at the oral hearing.  
1359European Communities' appellant's submission, para. 447.  WT/DS321/AB/R 
Page 278  
 
response;  (iii) long latency periods for cancer and c onfounding factors;  and (iv) adverse effects of 
the five hormones on growth and reproduction.  Th e European Communities also asserts that the 
relevant scientific evidence was insufficient in  relation to each of the five hormones assessed 
individually. 
661. Finally, the European Communities asserts th at the Panel failed to make an objective 
assessment of the facts, as required by Article 11 of the DSU, in reaching its findings under 
Article 5.7 of the  SPS Agreement .  The European Communities charges the Panel with ignoring Dr. 
Cogliano's statement that "the data are not suffici ent" to conduct a "low-dose prediction of risk at 
levels you might find in hormone-treated meat."
1360  The European Communities adds that the Panel 
"arbitrarily chose between different scientific opinion s" instead of determining whether the European 
Communities had "followed a scientifically plausible alternative"1361 when adopting 
Directive 2003/74/EC.  Therefore, the Panel impermissibly engaged in a  de novo  review of the 
scientific evidence in relation to the five horm ones, in violation of Article 11of the DSU. 
662. The United States responds that the Panel correctly  found that the relevant scientific evidence 
on the five hormones subject to the provisional ban was not "insufficient" within the meaning of 
Article 5.7 of the  SPS Agreement . 
663. The United States submits that the Panel correctly  interpreted Article 5.7, taking into account 
the context provided by Articles 3.2 and 3.3 of the  SPS Agreement .  This is because, in light of the 
presumption of consistency with the  SPS Agreement  that applies to measures which conform to 
international standards under Article 3.2, the Panel was justified in fi nding that the existence of such 
standards indicated that there ha d been sufficient scientific evid ence to conduct a risk assessment 
within the meaning of Article 5.1 for the five hormones at issue.1362  The United States also argues 
that the Panel correctly concluded that the Eur opean Communities' desired level of protection was 
irrelevant for the determination of whether the re levant scientific evidence on the five hormones was 
"insufficient" within the meaning of Article 5. 7.  The United States suggests that the European 
Communities failed to demonstrate that its chosen le vel of protection is different from the level of 
protection that the Codex standards for the hormones at issue are designed to achieve.1363  The United 
States adds that a risk assessment is a scientific pro cess aimed at identifying whether a risk exists and, 
                                                      
1360European Communities' appellant's submission, para. 279 (quoting transcript of the Panel's joint 
meeting with the scientific experts, Panel Reports, Annex G, para. 871).   
1361Ibid., para. 281.  
1362United States' appellee's submission, para. 70.  
1363Ibid., para. 71.   WT/DS321/AB/R 
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for this reason, risk assessors "need not have any pa rticular level of protection in mind in conducting 
the risk assessment."1364   
664. The United States also rejects the Europ ean Communities' assertion that the Panel 
misallocated the burden of proof in its analysis unde r Article 5.7.  The United States argues that the 
Panel correctly noted that "one of  the particularities of this case"1365 was that the European 
Communities' claim that the United States breached  Article 22.8 of the DSU was premised on an 
assertion that the European Communities had brought itself into conformity with the  SPS Agreement .  
Taking into account the European Communities' con cern that it should not be required to "prove a 
negative", all the Panel initially required was that the European Communities established a  prima 
facie  case of conformity with the  SPS Agreement .1366  According to the United States, the Panel only 
shifted the burden of proof to the United States once it had found that the European Communities had 
established such a  prima facie  case, and subsequently found that  the United States had rebutted the 
European Communities'  prima facie   case of conformity with the  SPS Agreement  "by submitting 
positive evidence that demonstrated a breach of the  SPS Agreement ".1367  The United States agrees 
with the Panel that "the burden [of proof] shifted back and forth between the parties and eventually 
'neutralized' each other since each party also submitted evidence in support of its allegations".1368  The 
United States further notes that "the Panel never d escribed or treated Article 5.7 as an exception to 
Article 5.1"1369, and for this reason the European Communitie s' allegation that the Panel interpreted 
Article 5.7 to be an exception to Article 5.1 is "speculation".1370 
665. The United States maintains that the Panel did not err in finding that "a critical mass of new 
evidence" is required to render previously suffici ent scientific evidence "ins ufficient" within the 
meaning of Article 5.7.  In the United States' view , the Panel's "critical mass" standard did not impose 
a minimum quantitative requirement, because it refers  to situations where "evidence becomes so 
quantitatively and qualitatively sufficient to call into  question the fundamental precepts of previous 
knowledge and evidence", such that new scientific info rmation is "at the origin of a change in the 
understanding of a scientific issue."1371  The United States considers that it was "appropriate" for the 
Panel to focus on the question of "wheth er the relevant scientific evidence had become  
insufficient"1372, because the five hormones at issue had been studied intensively for decades, 
                                                      
1364United States' appellee's submission, para. 72.  
1365Ibid., para. 93 (quoting Panel Report, US – Continued Suspension , para. 7.384).  
1366Ibid. 
1367Ibid., para. 93. 
1368Ibid., para. 94 (referring to Panel Report, US – Continued Suspension , para. 7.386).  
1369Ibid., para. 96. 
1370Ibid. 
1371Ibid., para. 78 (quoting Panel Report, US – Continued Suspension , para. 6.141). (emphasis omitted) 
1372Ibid., para. 80. (original emphasis)  WT/DS321/AB/R 
Page 280  
 
international standards for four of them had ex isted for over 20 years, and because the European 
Communities itself had argued in EC – Hormones  that the relevant scientific evidence on the five 
hormones was sufficient for it to conduct a risk asse ssment.  Thus, there was "plentiful" evidence on 
record demonstrating that the relevant scientific evidence "[was] and remains sufficient" to conduct a 
risk assessment for the five hormones.
1373 
666. Finally, the United States argues that the Panel did not fail to make an objective assessment of 
the facts as required by Article 11 of the DSU in  reaching its findings under Article 5.7 of the  SPS 
Agreement .  The United States asserts that the Panel acted  within the bounds of its discretion as the 
trier of the facts by attributing to the different pieces of evidence a different weight and significance 
than the one attributed by the European Communitie s.  The United States reiterates that "there was 
plentiful evidence in the record demonstra ting that the relevant scientific evidence"1374 remains 
sufficient to conduct a risk assessment for th ese five hormones, and therefore the Panel's 
consideration of whether there was a "'critical mass of new evidence' was proper and well-supported."
1375 
667. Canada also argues that the Panel properly fo und that the relevant scientific evidence on the 
five hormones subject to the provisional ban was not "insufficient" within the meaning of Article 5.7 
of the  SPS Agreement .   
668. Canada submits that the Panel correctly found that the existence of international standards 
"implies" that sufficient evidence has existed to  complete a risk assessment, in light of the 
presumption of compliance that applies to measures that conform with international standards under 
Article 3.2.1376  According to Canada, the Panel accepted th at this presumption could be rebutted, as it 
subsequently recognized that previously sufficient evidence could subsequently become "insufficient" 
within the meaning of Article 5.7 when it is "unsettled"1377 by new studies.  Canada considers that the 
Panel properly excluded from the scope of its analys is under Article 5.7 the level of protection chosen 
by the European Communities.  Canada asserts th at the European Communities' argument that the 
"sufficiency" of scientific evidence depends on th e acceptable level of risk adopted by a Member1378 
undermines the "basic logic" of the  SPS Agreement , according to which Article 5.7 operates as a 
                                                      
1373United States' appellee's submission, para. 81.  
1374Ibid. (referring to comments by the United States on the replies of the scientific experts, Codex, 
JECFA, and the IARC to questions posed by the Panel, Panel Reports, Annex F, paras. 47 and 48). 
1375Ibid., para. 82. 
1376Canada's appellee's submission, para. 118 (quoting Panel Report, Canada – Continued Suspension , 
para. 7.622).  
1377Ibid., para. 119 (quoting Panel Report, Canada – Continued Suspension , para. 7.598).  
1378Ibid., para. 121 (referring to European Commun ities' appellant's submission, para. 397.  WT/DS321/AB/R 
 Page 281 
 
 
"temporary 'safety valve'"1379 in situations where there is insu fficient scientific evidence to allow a 
Member to conduct a risk assessme nt that fulfils the requirements of Articles 2.2 and 5.1.   
669. Canada maintains that the Panel did not err in allocating to the European Communities the 
burden of proving the insufficiency of the scientific evidence under Article 5.7.  Canada additionally considers that the Panel correctly character ized Article 5.7 as a "qualified exemption"
1380 from the 
obligation under Article 2.2 not to maintain SPS measures without sufficien t scientific evidence and 
only shifted the burden of proof under Article 5.7 to the European Commun ities once it was satisfied 
that Canada had sufficiently refuted the Europ ean Communities' allegation of compliance through 
positive evidence of a breach of Article 5.7.  Canada posits further that this allocation of the burden of 
proof is consistent with the Appellate Body's ruling in US – Wool Shirts and Blouses , because it was 
for the European Communities, as the party alle ging a breach of Article 22.8 of the DSU, to 
demonstrate that its implementing measure complied with Article 5.7 of the  SPS Agreement .1381 
670. Moreover, Canada argues that the Panel did not  err in finding that, in situations where 
international risk assessments have been conducted for the substances at issue, a "critical mass" of 
new evidence would be required to render the rele vant scientific evidence "insufficient" for the 
purposes of Article 5.7.  Canada dismisses the Eur opean Communities' argument that the "critical 
mass" standard excludes  a priori  the possibility that a WTO Member base its risk assessment on 
respectable minority views, because in su ch situations there is "inherently"1382 sufficient evidence to 
perform a risk assessment that provides a basis for the SPS measure.  Canada asserts that Article 5.7 
only applies to situations where there is insufficien t scientific evidence so that it is not possible to 
conduct a risk assessment "at all", regardless of  whether a measure is based on minority or 
mainstream scientific opinions.1383  Canada adds that the notion of "critical mass" used by the Panel 
does not specify how much evidence would be needed  to make insufficient scientific evidence that 
was previously sufficient, and does not "exclude th e possibility that a new study or series of studies 
could call into question the scientific assumpti ons underpinning the current understanding of a 
scientific issue."1384  Thus, Canada submits, the Panel's "critical mass" standard "correctly sets a high 
threshold"1385 reflecting the presumption in this dispute th at the available scientific evidence had been 
sufficient to adopt the relevant international standards. 
                                                      
1379Canada's appellee's submission, para. 122.  
1380Ibid., para. 114 (quoting Appellate Body Report, Japan – Agricultural Products II , para. 80).   
1381Ibid., para. 115 (referring to Appellate Body Report, US – Wool Shirts and Blouses , p. 14, DSR 
1997:I, 323, at 335).   
1382Ibid., para. 127.  
1383Ibid., para. 128.  
1384Ibid. 
1385Ibid. WT/DS321/AB/R 
Page 282  
 
671. Canada also asserts that the Panel did not fail to conduct an objective assessment of the facts 
under Article 11 of the DSU in reaching its findings under Article 5.7 of the  SPS Agreement .  Canada 
observes that, as the trier of facts, the Panel had the discretion to determine what weight to attach to 
the statements made by the experts in the course of the proceedings, and assess their expertise and 
credibility.  Canada rejects the European Commun ities' allegations that th e Panel "systematically 
downplay[ed]"
1386 the expert opinions indicating that the sci entific evidence was in sufficient to carry 
out a risk assessment.  Such allegations fail to take  into account the fact that, in addition to reviewing 
the written answers by the experts to the Panel's questions, the Panel was able to "observe these 
experts" during the meetings with them and was able  to "arrive at an assessment of their respective 
expertise and their credibility in particular areas".1387  Therefore, Canada considers that the Panel's 
reliance on the views of these experts was commensurate with its function as the trier of facts, and 
consequently was consistent with Article 11 of the DSU. 
672. Australia agrees with the Europ ean Communities that the existence of international standards 
cannot be determinative of whether there is suffi cient evidence to conduct a risk assessment under the 
first requirement of Article 5.7 of the  SPS Agreement .1388  Australia also considers that the Panel's 
interpretation of Article 5. 7 failed to attribute significance to a Member's right under Article 3.3 of the 
SPS Agreement  to adopt measures that result in a higher le vel of protection than would be achieved 
by measures based on the relevant international standards.1389  
673. New Zealand disagrees with the European Communities' claims that the Panel erred in its 
assessment of Directive 2003/74/EC under Article 5.7 of the  SPS Agreement.   New Zealand argues 
that it was incumbent upon the European Communiti es, as the Member invoking Article 5.7, to 
demonstrate that the requirements of that provision have been met.1390  New Zealand submits that the 
Panel correctly concluded that the European Communities has failed to meet this burden.1391 
E. The Panel's Finding that the Relevant Sc ientific Evidence in Relation to the Five 
Hormones Was Not "Insufficient" Within the Meaning of Article 5.7 of the SPS 
Agreement 
674. Under Article 2.2 of the  SPS Agreement , WTO Members are required to "ensure that any 
sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or 
plant life or health, is based on scientific principles and is not maintained without sufficient scientific 
                                                      
1386Canada's appellee's submission, para. 130 (referring to European Communities' appellant's 
submission, paras. 427 and 429). 
1387Ibid., para. 130. 
1388Australia's third participant's submission, para. 55. 
1389Ibid., para. 56. 
1390New Zealand's third participant's submission, para. 3.58. 
1391Ibid., para. 3.60.  WT/DS321/AB/R 
 Page 283 
 
 
evidence, except as provided for in paragraph 7 of Ar ticle 5."  This requirement is made operative in 
other provisions of the SPS Agreement , including Article 5.1, which requires SPS measures to be 
"based on" a risk assessment.  At the same time, Article 2.2 excludes from its scope of application 
situations in which the relevant sci entific evidence is insufficient.  In  such situations, the applicable 
provision is Article 5.7 of the SPS Agreement .  Thus, the applicability of Articles 2.2 and 5.1, on the 
one hand, and of Article 5.7, on the other hand, will depend on the sufficiency of the scientific 
evidence.  The Appellate Body has explained that the relevant scientific evidence will be considered 
"insufficient" for purposes of Article 5.7 "if the bod y of available scientific evidence does not allow, 
in quantitative or qualitative terms,  the performance of an adequate assessment of risks as required 
under Article 5.1 and as defined in Annex A to the  SPS Agreement ."1392  This means that where the 
relevant scientific evidence is sufficient to perfo rm a risk assessment, as defined in Annex A of the 
SPS Agreement , a WTO Member may take an SPS measure onl y if it is "based on" a risk assessment 
in accordance with Article 5.1 and that SPS measure is also subject to the obligations in Article 2.2.  
If the relevant scientific evidence is insufficient to perform a risk assessment, a WTO Member may 
take a provisional SPS measure on the basis provided in Article 5.7, but that Member must meet the 
obligations set out in that provision. 
675. Having discussed the relationship between Article s 2.2, 5.1 and 5.7, we now focus on the 
conditions for the application of a provisional SPS measure pursuant to the latter provision.  
Article 5.7 provides: 
In cases where relevant scientific ev idence is insufficient, a Member 
may provisionally adopt sanitary or phytosanitary measures on the 
basis of available pertinent info rmation, including that from the 
relevant international organizati ons as well as from sanitary or 
phytosanitary measures applied by other Members.  In such circumstances, Members shall seek to obtain the additional 
information necessary for a more objective assessment of risk and 
review the sanitary or phytosanitary measure accordingly within a reasonable period of time. 
676. The Appellate Body has explained that Article  5.7 sets out four obligations.  Two of these 
obligations set conditions that must be met before  a provisional SPS measure is adopted.  The other 
two obligations are conditions for maintaining the provisional SPS measure once it has been taken.  
These four obligations are:  
(1) [the measure is] imposed in resp ect of a situation where "relevant 
scientific information is insufficient";  
                                                     
 
1392Appellate Body Report, Japan – Apples , para. 179.  WT/DS321/AB/R 
Page 284  
 
(2) [the measure is] adopted "on the basis of available pertinent information"; 
(3) [the Member that adopted th e measure] "seek[s] to obtain the 
additional information necessary for a more objective assessment of risk";  and  
(4) [the Member that adopted the measure] "review[s] the ... measure 
accordingly within a reasonable period of time."
1393  
677. Article 5.7 begins with the requirement th at the "relevant scientific evidence" be 
"insufficient".  As explained earlier, the relevant scientific evidence is "insufficient" where "the body 
of available scientific evidence does not allow, in quantitative or qualitative terms, the performance of 
an adequate assessment of risks as required under Ar ticle 5.1 and as defined in Annex A to the  SPS 
Agreement ."1394  Under Article 5.1, WTO Members are al lowed to base SPS measures on divergent or 
minority views provided they are from a respected and qualified source.1395  Thus the existence of 
scientific controversy in itself is not enough to c onclude that the relevant scientific evidence is 
"insufficient".  It may be possible to perform a risk assessment that meets the requirements of 
Article 5.1 even when there are divergent views in the scientific community in relation to a particular 
risk.  By contrast, Article 5.7 is concerned with s ituations where deficiencies in the body of scientific 
evidence do not allow a WTO Member to arrive at a sufficiently objective conclusion in relation to 
risk.  When determining whether such defici encies exist, a Member must not exclude from 
consideration relevant scientific evidence from any qualified and respected source.  Where there is, 
among other opinions, a qualified and respected scientif ic view that puts into question the relationship 
between the relevant scientific evidence and the conc lusions in relation to risk, thereby not permitting 
the performance of a sufficiently objective assessment of  risk on the basis of the existing scientific 
evidence, then a Member may adopt provisional me asures under Article 5.7 on the basis of that 
qualified and respected view. 
678. WTO Members' right to take provisional measures in circumstances where the relevant 
scientific information is "insufficient" is also subject to the requirement that such measures be 
adopted "on the basis of available pertinent inform ation".  Such information may include information 
from "the relevant international organizations" or deriving from SPS measures applied by other WTO 
Members.  Thus, Article 5.7 contemplates situations  where there is some evidentiary basis indicating 
the possible existence of a risk, but not enough to permit the performance of a risk assessment.  
Moreover, there must be a rational and objective relationship between the information concerning a 
certain risk and a Member's provisional SPS measure.  In this sense, Article 5.7 provides a "temporary 
                                                      
1393Appellate Body Report, Japan – Agricultural Products II , para. 89.  
1394Appellate Body Report, Japan – Apples , para. 179.  
1395See supra , section VI.E.  WT/DS321/AB/R 
 Page 285 
 
 
'safety valve' in situations where some evidence of a risk exists but not enough  to complete a full risk 
assessment, thus making it impossible to meet the more rigorous standards set by Articles 2.2 
and 5.1."1396  
679. The second sentence of Article 5.7 requires that  the available pertinent information which 
provides a basis for a Member's provisional SPS me asure be supplemented with "the additional 
information necessary for a more objective assessment of risk" within a "reasonable period of time".  
As the Appellate Body noted, these two conditions  "relate to the  maintenance  of a provisional [SPS] 
measure and highlight the  provisional  nature of measures adopted pursuant to Article 5.7."1397  The 
requirement that the WTO Member "shall seek to obtain the additional in formation necessary for a 
more objective assessment of risk" implies that, as of  the adoption of the provisional measure, a WTO 
Member must make best efforts to remedy the insu fficiencies in the relevant  scientific evidence with 
additional scientific research or by gathering inform ation from relevant intern ational organizations or 
other sources.1398  Otherwise, the provisional nature of measures taken pursuant to Article 5.7 would 
lose meaning.  The "insufficiency" of the scientific  evidence is not a perennial state, but rather a 
transitory one, which lasts only until such time as the imposing Member procures the additional 
scientific evidence which allows th e performance of a more objective assessment of risk.  The 
Appellate Body has noted that Article 5.7 does not set out "explicit prerequisites regarding the 
additional information to be collected  or a specific collection procedure".1399  Nevertheless, the WTO 
Member adopting a provisional SPS measure should be  able to identify the insufficiencies in the 
relevant scientific evidence, and the steps that it in tends to take to obtain the additional information 
that will be necessary to address these  deficiencies in order to make  a more objective assessment and 
review the provisional measure within a reasonable pe riod of time.  The additional information to be 
collected must be "germane" to conducti ng the assessment of  the specific risk.1400  A  M e m b e r  i s  
required under Article 5.7 to seek to obtain additio nal information but is not expected to guarantee 
specific results.  Nor is it expected  to predict the actual results of its efforts to collect additional 
information at the time when it adopts the SPS measur e.  Finally, the Member taking the provisional 
SPS measure must review it within a reasonable period of time.1401 
                                                      
1396Canada's appellee's submission, para. 114.  
1397Appellate Body Report, Japan – Apples , footnote 318 to para. 176. (original emphasis) 
1398Pursuant to Article 10.1 of the  SPS Agreement , due account shall be taken of the special needs of 
developing country Members in respect of their ability to procure the additional information for a more objective assessment of risk. 
1399Appellate Body Report Japan – Agricultural Products II , para. 92.   
1400Ibid. 
1401"[W]hat constitutes a 'reasonable period of time' ... depends on the specific circumstances of each 
case, including the difficulty of obtaining additional information necessary for the review  and  the 
characteristics of the provisional SPS measure." ( Ibid., para. 93) (original emphasis) WT/DS321/AB/R 
Page 286  
 
680. These four conditions set out in Article 5.7, however, must be interpreted keeping in mind 
that the precautionary principle finds reflection in this provision.
1402  As the Appellate Body has 
emphasized:  
a panel charged with determining, for instance, whether "sufficient 
scientific evidence" exists to warra nt the maintenance by a Member 
of a particular SPS measure may, of course, and should, bear in mind 
that responsible, representative governments commonly act from the 
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to human health are concerned.
1403   
In emergency situations, for example, a WTO Member will take a provisional SPS measure on the 
basis of limited information and the steps it takes to comply with its obligations to seek to obtain 
additional information and review the measure will be  assessed in the light of the exigencies of the 
emergency.  
681. The European Communities argues that SPS measure s are either "based on" a risk assessment 
under Article 5.1, or otherwise the relevant scientif ic evidence will be "insufficient" within the 
meaning of Article 5.7, so that provisional SPS measu res may be justified.  We do not agree.  There 
may be situations where the relevant scientific ev idence is sufficient to perform a risk assessment, a 
WTO Member performs such a risk assessment, but does not adopt an SPS measure either because the 
risk assessment did not confirm the risk, or the ri sk identified did not exceed that Member's chosen 
level of protection.  Also, there may be situations  where there is no pertinent scientific information 
available indicating a risk such that an SPS me asure would be unwarranted even on a provisional 
basis. 
1. Insufficiency and the Acceptable Level of Protection  
682. The European Communities argues that the Pa nel failed to take into account that the 
European Communities had chosen a higher level of protection when determining whether the 
relevant scientific evidence is "insufficient"  within the meaning of Article 5.7 of the SPS 
Agreement .1404  According to the European Communities, the context provided by Article 3.3 of the 
SPS Agreement, and the cross-referenc e to Article 5 contained therein, compels a panel to consider a 
Member's chosen level of protection in examining whether the requirements of Article 5.7 have been 
met.  As we noted earlier, Article 3.3 permits that WTO Members adopt measures which result in a 
higher level of protection than the one achieved by measures based on the relevant international 
standards.  
                                                      
1402Appellate Body Report, EC – Hormones , para. 124. 
1403Ibid.  
1404See European Communities' appellant's submission, paras. 397 and 398.  WT/DS321/AB/R 
 Page 287 
 
 
683. In their appellee's submissions, both the United States and Canada emphasize that risk 
assessment is an "objective" process aimed at iden tifying and evaluating a certain risk, and that a 
Member's appropriate level of protection is therefore entirely separate from the question of whether 
scientific evidence is "insufficien t" to perform a risk assessment.1405  At the oral hearing, however, the 
United States and Canada recognized that the chosen level of protection may have a role to play in 
framing the scope and methods of a risk assessment  in the particular circumstances where a WTO 
Member chooses a higher level of protection than th at which would be achieved by a measure based 
on the international standard.  
684. The Panel noted that the terms of Article 5.1 and Annex A of the  SPS Agreement  "do not 
indicate that a Member's level of protection is per tinent to determine whether a risk assessment can be 
performed or not."1406  The Panel quoted approvingly the reasoning of the panel in EC – Approval and 
Marketing of Biotech Products , which stated that "[t]he protecti on goals of a legislator may have a 
bearing on the question of which risks a Member deci des to assess .... [a]nd are certainly relevant to 
the determination of the measure ... to be taken fo r achieving a Member's level of protection against 
risk.  Yet there is no apparent link between a legi slator's protection goals and the task of assessing the 
existence and magnitude of potential risks."1407  The Panel concluded that: 
The assessment [of] whether there is  sufficient scientific evidence or 
not to perform a risk assessment should be an objective process.  The 
level of protection defined by each  Member may be relevant to 
determine the measure to be select ed to address the assessed risk, but 
it should not influence the perform ance of the risk assessment as 
such.   
Indeed, whether a Member considers that its population should be 
exposed or not to a particular risk, or at what level, is not relevant to 
determining whether a risk exists and what its magnitude is.  A 
fortiori , it should have no effect on whether there is sufficient 
evidence of the existence and magnitude of this risk.  
A risk-averse Member may be inc lined to take a protective position 
when considering the measure to be adopted.  However, the 
determination of whether scientific evidence is sufficient to assess 
the existence and magnitude of a ri sk must be disconnected from the 
intended level of protection.1408 
                                                      
1405See United States' appellee's submission, paras. 72 and 73;  and Canada's appellee's submission, 
paras. 121 and 122. 
1406Panel Report, US – Continued Suspension , para. 7.609;  Panel Report, Canada – Continued 
Suspension , para. 7.587. 
1407Ibid. (quoting Panel Report, EC – Approval and Marketing of Biotech Products , para. 7.3238).  
1408Panel Report, US – Continued Suspension , paras. 7.610-7.612;  Panel Report, Canada – Continued 
Suspension , paras. 7.588-7.590.  WT/DS321/AB/R 
Page 288  
 
685. A WTO Member that adopts an SPS measure resulting in a higher level of protection than 
would be achieved by measures base d on international standards must nevertheless ensure that its SPS 
measure complies with the other requirements of the  SPS Agreement , in particular Article 5.
1409  This 
includes the requirement to perform a risk assessment.1410  At the same time, we recognize that, in 
order to perform a risk assessment, a WTO Member  may need scientific information that was not 
examined in the process leading to the adoption of the international standard.  We see no basis in 
Articles 3.3 and 5.1 of the  SPS Agreement   to conclude that WTO Me mbers choosing a higher level 
of protection than would be achieved by a measure based on an international standard must frame the 
scope and methods of its risk asse ssment, including the scientific information to be examined, in the 
same manner as the international body that performed  the risk assessment underlying the international 
standard.  Thus, where the chosen level of protectio n is higher than would be achieved by a measure 
based on an international standard, this may have some bearing on the scope or method of the risk 
assessment.1411  In such a situation, the fact that the WT O Member has chosen to set a higher level of 
protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered a nd the research carried out in the risk assessment underlying the 
international standard. 
686. For these reasons, we disagree with the Panel's finding that "the determination of whether 
scientific evidence is sufficient to  assess the existence and magnitude of a risk must be disconnected 
from the intended level of protection."
1412  We emphasize, however, that whatever level of protection 
a WTO Member chooses does not pre-determine the out come of its determination of the sufficiency 
of the relevant scientific evidence.  The determin ation as to whether available scientific evidence is 
sufficient to perform a risk assessment must re main, in essence, a rigorous and objective process.1413   
687. The European Communities refers  to the chosen level of protection to support its argument 
that the existence of JECFA risk assessments for th e five hormones does not necessarily mean that the 
relevant scientific evidence was sufficient for th e European Communities to perform its own risk 
assessment.  Before the Panel, th e European Communities explained that "the evidence which served 
as the basis for the 1988 and 1999-2000 JECFA evalua tions is not sufficient 'to perform a definitive 
risk assessment within the meaning of Article 5.7, in particular by the WTO Members applying a high 
                                                      
1409Article 3.3 of the  SPS Agreement . 
1410Appellate Body Report, EC – Hormones , paras. 176 and 177. 
1411We noted earlier that, at the or al hearing, the United States a nd Canada recognized that the 
acceptable level of risk may sometimes play a role, albe it a limited one, in respect  of the risk assessment. 
1412Panel Report, US – Continued Suspension , para. 7.612;  Panel Report, Canada – Continued 
Suspension , para. 7.590.  
1413The Appellate Body has held in relation to risk assessments under Article 5.1 that the assessment 
"should not be distorted by preconceived 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 ." (Appellate Body Report, Japan – Apples , para. 208)  WT/DS321/AB/R 
 Page 289 
 
 
level of health protection of no risk from expos ure to unnecessary additional residues in meat of 
animals treated with hormones for growth promotion'."1414  We turn to this issue next. 
2. Relevance of International Standa rds under Article 5.7 of the  SPS Agreement    
688. The European Communities claims that the Pane l erred in finding that the existence of 
international standards demonstrates "sufficiency" of scientific evidence to perform a risk assessment 
within the meaning of Article 5.1 of the  SPS Agreement , and thereby precludes adoption of 
provisional measures under Article 5.7.  Accord ing to the European Communities, the Panel 
considered that the existence of internationa l standards established an "irrebuttable presumption"1415 
that the relevant scientific evidence in this case is not  "insufficient" for the purposes of Article 5.7.  
689. After recalling that international standards,  guidelines or recommendations existed with 
respect to progesterone, testosterone, trenbolone  acetate, and zeranol, the Panel observed "the 
important role given"1416 to international standards by the  SPS Agreement , and recalled that 
Article 3.2 of the  SPS Agreement  provides that measures which confor m to international standards, 
guidelines or recommendations shall be presumed to be consistent with the relevant provisions of the 
SPS Agreement .  On this basis, the Panel concluded that:  
The presumption of consistency of measures conforming to 
international standards, guidelines and recommendations with the relevant provisions of the SPS Agreement  implies that these 
standards, guidelines or recommendations, particularly those referred 
to in this case, are based on risk assessments that meet the 
requirements of the SPS Agreement .  This means, therefore, that there 
was sufficient evidence for JECFA to undertake the appropriate risk 
assessments.
1417   
690. In relation to MGA, the Panel noted that, even though Codex has not adopted a standard for 
this substance, "intensive work"1418 has been performed at the intern ational level.  The Panel observed 
that JECFA has conducted two risk assessments of MGA in 2000 and 2004, and that MGA is 
currently at Step 7 of the Codex international sta ndards elaboration procedure.  The Panel concluded 
                                                      
1414Panel Report, US – Continued Suspension , para. 7.604;  Panel Report, Canada – Continued 
Suspension , para. 7.579 (quoting European Communities' second  written submission, para. 149, and reply of the 
European Communities to Question 31 posed by the Panel after the first substantive meeting, Panel Reports, 
Annex B-1, paras. 167-172). 
1415European Communities' appellant's submission, para. 406.  
1416Panel Report, US – Continued Suspension , para. 7.643;  Panel Report, Canada – Continued 
Suspension , para. 7.621.   
1417Panel Report, US – Continued Suspension , para. 7.644;  Panel Report, Canada – Continued 
Suspension , para. 7.622.  
1418Panel Report, US – Continued Suspension , para. 7.813;  Panel Report, Canada – Continued 
Suspension , para. 7.799.   WT/DS321/AB/R 
Page 290  
 
that "the role of JECFA in the international ri sk assessment process is such that some degree of 
relevance should be given to that work."
1419 
691. On appeal, the European Commun ities argues that, under the Panel's interpretation, "the mere 
existence of an international standard would  ipso jure  make it impossible for a Member to adopt 
measures under Article 5.7 of the  SPS Agreement ."1420  According to the European Communities, the 
presumption of consistency that applies to measure s that conform to international standards under 
Article 3.2 of the  SPS Agreement1421  does not necessarily lead to the conclusion that the risk 
assessment underlying the international standards is consistent with the SPS Agreement ; nor does this 
presumption establish that scientific evidence underlyi ng the international standards is sufficient to 
conduct a risk assessment under Article 5.1.  This is  so particularly where a Member chooses not to 
conform to such international standards pursuant to  Article 3.2 and introduces measures that result in 
a higher level of SPS protection than would be achie ved by measures based on international standards 
pursuant to Article 3.3.  
692. As the preamble of the  SPS Agreement  recognizes, one of the primary objectives of the  SPS 
Agreement  is to "further the use of harmonized san itary and phytosanitary measures between 
Members, on the basis of international standard s, guidelines and recommendations developed by the 
relevant internati onal organizations".1422  This objective finds reflection in Article 3 of the  SPS 
Agreement , which encourages the harmonization of SPS measures on the basis of international 
standards, while at the same time recognizing the WTO Members' right to determine their appropriate 
level of protection.1423  Article 3.1 of the  SPS Agreement  establishes that Members shall "base their 
                                                      
1419Panel Report, US – Continued Suspension , para. 7.813;  Panel Report, Canada – Continued 
Suspension , para. 7.799.  
1420European Communities' appellant's submission, para. 393.  
1421Article 3.2 provides:  
Sanitary or phytosanitary measures which conform to international 
standards, guidelines or recommendations shall be deemed to be necessary 
to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of 
GATT 1994.   
1422See also Appellate Body Report, EC – Hormones , para. 165.  
1423As the Appellate Body explained in EC – Hormones :  
In generalized terms, the object and purpose of Article 3 is to promote the 
harmonization of the SPS measures of Members on as wide a basis as possible, while recognizing and safeguar ding, at the same time, the right and 
duty of Members to protect the life and health of their people.  The ultimate 
goal of the harmonization of SPS measures is to prevent the use of such measures for arbitrary or unjustifiable discrimination between Members or a 
disguised restriction on internationa l trade, without preventing Members 
from adopting or enforcing measures which are both "necessary to protect" human life or health and "based on scientific principles", and without 
requiring them to change their appropriate level of protection. 
(
Ibid., para. 177)  WT/DS321/AB/R 
 Page 291 
 
 
[SPS] measures on international sta ndards, guidelines or recommendations, where they exist, except 
as otherwise provided in this Agreement, and in particular in paragraph 3."   
693. The relevant "international standards, guidelin es or recommendations" that are referred to in 
Articles 3.1 and 3.2 are those set by the internationa l organizations listed in Annex A, paragraph 3 of 
the  SPS Agreement , which includes Codex as the relevant sta ndard-setting organization for matters of 
food safety.1424  As we noted above, Codex adopts interna tional standards for veterinary drug residues 
based on evaluations performed by JECFA.  In this  case, Codex has adopted international standards 
for testosterone, progesterone, trenbolone acetate, and zeranol, on the basis of evaluation performed 
by JECFA.1425  In addition, Codex has initiated a standard-setting process for MGA, also on the basis 
of JECFA's evaluation, but this process has not yet been concluded. 
694. It is therefore undisputed that JECFA has perfo rmed risk assessments fo r the six hormones at 
issue and that Codex has adopted international sta ndards for five of these hormones on the basis of 
JECFA's risk assessments.  The fact that JECFA has performed risk assessments for all six hormones 
means that the relevant scientific evidence was in  its estimation sufficient to do so.  Article 3.2 
provides that SPS measures which conform to intern ational standards shall be deemed necessary to 
protect human, animal or plant life or health, and sha ll be presumed to be consistent with the relevant 
provisions of the  SPS Agreement  and of the GATT 1994.  This presumption, however, does not 
apply where a Member has not adopted a measure th at conforms with an international standard.  
Article 3.2 is inapplicable where a Member chooses a level of protection that is higher than would be 
achieved by a measure based on an international st andard.  The presumption in Article 3.2 cannot be 
interpreted to imply that there is sufficient scien tific evidence to perform a risk assessment where a 
Member chooses a higher level of protection.  
695. This is borne out by Article 5.7, which provides that WTO Members may adopt provisional 
SPS measures "on the basis of available pertinent information, including that from the relevant 
international organizations as well as from sanitary or phytosanitary measures applied by other 
Members".  There is no indication in Article 5.7 that a WTO Member may not take a provisional SPS 
measure wherever a relevant international organi zation or another Member has performed a risk 
assessment.  Information from relevant internati onal organizations may not necessarily be considered 
"sufficient" to perform a risk assessment, as it ma y be part of the "available pertinent information"
                                                      
1424Paragraph 3(a) of Annex A of the  SPS Agreement  reads: 
... for food safety, the standards,  guidelines and recommendations 
established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticid e residues, contaminants, methods of 
analysis and sampling, and codes and guidelines of hygienic practice. 
1425See supra , footnote 933. WT/DS321/AB/R 
Page 292  
 
which provides the basis for a provisional SPS measu re under Article 5.7.  Moreover, scientific 
evidence that may have been relied upon by an international body when performing the risk 
assessment that led to the adoption of an international standard at a certain point in time may no 
longer be valid, or may become insufficient in th e light of subsequent sci entific developments.  
Therefore, the existence of a risk assessment performed by JECFA does not mean that scientific 
evidence underlying it must be considered to be su fficient within the meaning of Article 5.7.   
696. In our view, it is reasonable for a WTO Member  challenging the consistency with Article 5.7 
of a provisional SPS measure adopted by another Me mber to submit JECFA's risk assessments and 
supporting studies leading to the adoption of intern ational standards as evidence that the scientific 
evidence is not insufficient to perfo rm a risk assessment.  However,  such evidence is not dispositive 
and may be rebutted by the Member taking the provisional SPS measure. 
697. The European Communities argues that the Panel considered th e existence of international 
standards as establishing an "irrebuttable presumption"
1426 that the relevant scien tific evidence in this 
case is not "insufficient" for the purposes of Article 5. 7.  As we pointed out above, the existence of an 
international standard does not create a legal presump tion of sufficiency for purposes of Article 5.7.  
The Panel recognized that "[i]t cannot be excluded that new scientific evidence or information call 
into question existing evidence", and acknowledged th e possibility that "different risk assessments 
reach different interpretations of  the same scientific evidence."1427  The Panel examined the specific 
points raised by the European Communities concerni ng the insufficiencies it saw in the scientific 
evidence considered in JECFA's risk  assessment.  There would not have been a need for the Panel to 
undertake such an assessment if it had considered that the existence of international standards 
established an irrebuttable presumption that the re levant scientific evidence was not insufficient 
within the meaning of Article 5.7.  Thus we find no fa ult with the Panel to the extent that it treated the 
evidence underlying JECFA's risk assessment as havi ng probative value for determining whether the 
relevant scientific evidence was in sufficient.  In our view, the ex istence of risk assessments conducted 
by JECFA in relation to the five hormones at issue has probative value, but is not dispositive, of the 
question of whether the relevant scientific evidence  on those hormones is "insufficient" within the 
meaning of Article 5.7. 
698. The Panel relied on the existence of internationa l standards to adopt a "critical mass" test for 
determining when scientific information that was previously considered sufficient becomes 
                                                      
1426European Communities' appellant's submission, para. 406.  
1427Panel Report, US – Continued Suspension , para. 7.645;  Panel Report, Canada – Continued 
Suspension , para. 7.623.   WT/DS321/AB/R 
 Page 293 
 
 
insufficient for purposes of Article 5.7 of the  SPS Agreement .  The European Communities also 
challenges this test on appeal.  We examin e this issue in the section that follows. 
3. The Panel's "Critical Mass" Standard for Determining "Insufficiency" under 
Article 5.7 of the  SPS Agreement  
699. The European Communities asserts that the Pa nel's "critical mass" standard imposed an 
excessively "high quantitative and qualitative threshold"  with respect to the new evidence that is 
required to render "insufficient" scientific eviden ce that was previously  considered sufficient.1428  
According to the European Communities, the quality of  the scientific evidence is more important than 
the quantity, and therefore even a single study could be considered a priori sufficient to question the 
sufficiency of previous scientific evidence.1429  The European Communities adds that the Panel's 
"critical mass" standard effectively precluded the application of the precautionary principle in the 
interpretation of Articles 5.1 and 5.7, because th e scientific evidence would pass immediately from a 
state of insufficiency under Article 5.7 to a state of sufficiency under Article 5.1.1430  
700. Both the United States and Canada accept that  evidence which at some point in time was 
sufficient to perform a risk assessment could b ecome insufficient at a later point in time.1431  T h e  
United States said this could happen, for example, if there was new pathway for a risk for which the 
information was insufficient.1432  Canada gave as an example th e situation in which there is new 
scientific data that identifies new adverse effect s or adverse effects at lower exposure levels.1433  
Another example given by Canada is the identification of new sources of exposure.1434  The Panel also 
recognized that: 
... there could be situations where existing scientific evidence can be 
put in question by new studies and information.  There could even be situations where evidence which supported a risk assessment is 
unsettled by new studies which do not  constitute sufficient relevant 
scientific evidence as such to su pport a risk assessment but are 
sufficient to make the existing, previously relevant scientific evidence insufficient.
1435  (footnote omitted) 
                                                      
1428European Communities' appellant's submission, para. 412. 
1429Ibid., para. 413. 
1430Ibid., para. 427. 
1431Panel Report, US – Continued Suspension , para. 7.617;  Panel Report, Canada – Continued 
Suspension , para. 7.593. 
1432Panel Report, US – Continued Suspension , para. 7.617. 
1433Panel Report, Canada – Continued Suspension , para. 7.593. 
1434In addition, Canada mentioned the situation where there is a change in the basic understanding of a 
biological event that is triggered by the chemical under assessment. (Panel Report, Canada – Continued 
Suspension , para. 7.593) 
1435Panel Report, US – Continued Suspension , para. 7.620;  Panel Report, Canada – Continued 
Suspension , para. 7.598.  WT/DS321/AB/R 
Page 294  
 
701. We agree that scientific progress may lead a WT O Member and international organizations to 
reconsider the risk assessment underlying an  SPS measure.  In some cases, new scientific 
developments will permit a WTO Member to conduct a new risk assessment with the sufficient degree 
of objectivity.  There may be situations, however, where the new scientific developments themselves 
do not permit the performance of a new risk assessment that is sufficiently objective.  Such a situation 
would fall within the scope of Article 5.7 of the SPS Agreement .   
702. The Appellate Body has explained that "'relevant  scientific evidence' will be 'insufficient' 
within the meaning of Article 5.7 if the body of  available scientific evidence does not allow, in 
quantitative or qualitative terms, the performance of an adequate assessment of risks as required under 
Article 5.1 and as defined in Annex A to the  SPS Agreement ."
1436  The body of scientific evidence 
underlying a risk assessment can always be supplem ented with additional info rmation.  Indeed, the 
nature of scientific inquiry is such that it is always possible to conduct more research or obtain 
additional information.  The possibility of conduc ting further research or of analyzing additional 
information, by itself, should not me an that the relevant scientific evid ence is or becomes insufficient.   
703. Moreover, as the Panel noted, science continuously evolves.1437  It may be useful to think of 
the degree of change as a spectrum.  On one extrem e of this spectrum lies the incremental advance of 
science.  Where these scientific advances are at the margins, they would not support the conclusion 
that previously sufficient evidence has become insufficient.  At the other extreme lie the more radical 
scientific changes that lead to a paradigm shift.  Such radical change is not frequent.  Limiting the 
application of Article 5.7 to situations where scientif ic advances lead to a paradigm shift would be too 
inflexible an approach.  WTO Members should be permitted to take a provisional measure where new 
evidence from a qualified and respected source puts into question the relationship between the pre-
existing body of scientific eviden ce and the conclusions regarding the risks.  We are referring to 
circumstances where new scientific evidence casts doubts as to whether the previously existing body 
of scientific evidence still permits of a su fficiently objective assessment of risk. 
704. The Panel next discussed its understanding of "i nsufficiency" in the specific circumstances 
where international standards exist for the particular substance.  It concluded: 
We therefore conclude that if relevant evidence already exists, not 
any degree of insufficiency will satisfy the criterion under Article 5.7 that "relevant scientific evidence is  insufficient". Having regard to 
our reasoning above, particularly with respect to scientific uncertainty and the existence of inte rnational standards, we consider 
                                                     
 
1436Appellate Body Report, Japan – Apples , para. 179.  
1437Panel Report, US – Continued Suspension , para. 7.645;  Panel Report, Canada – Continued 
Suspension , para. 7.623.  WT/DS321/AB/R 
 Page 295 
 
 
that, depending on the existing relevant evidence, there must be a critical mass  of new evidence and/or information that calls into 
question the fundamental precepts  of previous knowledge and 
evidence so as to make relevant, previously sufficient, evidence now 
insufficient.  In the present case wh ere risk assessments have been 
performed and a large body of quality evidence has been 
accumulated, this would be possi ble only if it put into question 
existing relevant evidence to the point that  this evidence is no longer 
sufficient to support the conclusi ons of existing risks assessments.
1438  
(original emphasis;  footnote omitted) 
705. The Panel's statement that "there must be a critical mass  of new evidence and/or information 
that calls into question the fundamental precepts of  previous knowledge and evidence so as to make 
relevant, previously sufficient, evidence now insuffi cient" could be understood as requiring that the 
new scientific evidence lead to a pa radigm shift.  As we have said, su ch an approach is too inflexible.  
Although the new evidence must call into question the relationship between the body of scientific 
evidence and the conclusions concerning risk, it need  not rise to the level of a paradigm shift.   
706. Some of the Panel's statements intended to e xplain what it meant by "critical mass" similarly 
can be understood as requiring a paradigm shift, which is too high a threshold.  At the interim review 
stage, the European Communities requested that th e Panel identify the provenance of the "critical 
mass" standard and explain how it should be r econciled with the Appellate Body's findings in EC – 
Hormones .  The Panel responded as follows: 
The Panel used the term "critical mass" in full knowledge of its 
meaning.294  It used it in the sense of  a situation where evidence 
becomes quantitatively and qualitatively sufficient to call into 
question the fundamental precepts  of previous knowledge and 
evidence.  The Panel does not mean  that there must be sufficient 
evidence to perform a new risk assessment.  Otherwise, Article 5.7 of the SPS Agreement  would become meaningless.  It used the term 
"critical mass" very much in its common scientific usage, i.e. the new 
scientific information and evidence must be such that they are at the 
origin  of a change in the understanding of a scientific issue.  We do 
not see in what respect this approach  by the Panel, which applies to 
the specific situation in this case (i .e. one where a party alleges that 
previously sufficient scientific ev idence has become insufficient) 
would be contrary to the findings of the Appellate Body in EC – 
Hormones.
1439  (original emphasis) 
_____________ 
294In mathematics and physics "critical" is defined as "constituting or 
relating to a point of transition from one state, etc. to another".  "Critical 
size" or "critical mass" are defined as  the minimum size or mass of a body 
of a given fissile material which is capable of sustaining a nuclear chain 
                                                      
1438Panel Report, US – Continued Suspension , para. 7.648;  Panel Report, Canada – Continued 
Suspension , para. 7.626.  
1439Panel Report, US – Continued Suspension , para. 6.141;  Panel Report, Canada – Continued 
Suspension , para. 6.133.  WT/DS321/AB/R 
Page 296  
 
reaction (Shorter Oxford English Dictionary, 5th edition (1993), p. 558). In 
other words, the Panel assessed whether it had been provided with the minimum evidence necessary to conc lude that knowledge has become 
quantitatively and qualitatively sufficient to call into question the 
fundamental precepts of previous knowledge and evidence. 
707. In the reasoning quoted above, the Panel agai n required that the scientific evidence be 
"sufficient to call into question the fundamental pr ecepts of previous knowledge and evidence".  The 
Panel's explanation that "the new scientific inform ation and evidence must be such that they are at the 
origin  of a change in the understanding of a scientific issue" also connotes a paradigm shift.  
708. We earlier observed that the existence of an in ternational standard for which a risk assessment 
was conducted could be offered as evidence in suppor t of an assertion that the relevant scientific 
evidence is not insufficient within the meaning of Article 5.7 of the  SPS Agreement .  It is an 
evidentiary issue in the sense that  the scientific information underlyi ng the international standard has 
probative value as to the sufficien cy of the scientific evidence needed for conducting a risk 
assessment at a discrete point in time.  However,  in circumstances where a Member adopts a higher 
level of protection than that reflected in the intern ational standard, the legal test that applies to the 
"insufficiency" of the evidence under Article 5.7 is not made stricter.  Thus, it is incorrect to use 
JECFA's risk assessments as a legal benchmark for assessing insufficiency as the Panel did in this 
case. 
709. In the interim review, the Panel expressly recogn ized that it used JECFA's risk assessments as 
a "benchmark": 
[I]t is correct that the Panel considered that, in order to determine 
whether relevant scientific evid ence was insufficient within the 
meaning of Article 5.7 of the SPS Agreement , it had to take the 
results of the risk assessments made by JECFA as a "benchmark" of 
the existence of sufficient scientific evidence. This is in line with the 
findings of the Appellate Body in Japan – Apples  that the relevant 
scientific evidence will be insufficient within the meaning of Article 5.7 if the body of available scientific evidence does not allow, in quantitative or qualitative terms,  the performance of an adequate 
assessment of risks as required under Article 5.1 and as defined in 
Annex A to the SPS Agreement , as well as with the presumption of 
compliance under Article 3.2 of the SPS Agreement .
1440  (footnote 
omitted) 
710. We recall that the presumption in Article 3.2 is  inapplicable where a WTO Member adopts an 
SPS measure that results in a higher level of protection than that reflected in an international standard.  
For this reason, Article 3.2 did not provide a basis for the Panel's use of the JECFA risk assessments 
                                                      
1440Panel Report, US – Continued Suspension , para. 6.60;  Panel Report, Canada – Continued 
Suspension , para. 6.55.    WT/DS321/AB/R 
 Page 297 
 
 
as the legal benchmark against which the insufficien cies in the relevant scientific evidence identified 
by the European Communities had to be evalua ted.  As the Appellate Body explained in  EC – 
Hormones :   
The presumption of consistency w ith relevant provisions of the SPS 
Agreement  that arises under Article 3.2 in respect of measures that 
conform to international standards may well be an incentive  for 
Members so to conform their SPS measures with such standards.  It 
is clear, however, that a decision of a Member not to conform a particular measure with an intern ational standard does not authorize 
imposition of a special or generalized burden of proof upon that Member, which may, more often than not, amount to a  penalty .
1441  
(original emphasis) 
711. The particular insufficiencies in the relevant scientific evidence identif ied by the European 
Communities had to be evaluated on their own terms.  As indicated earlier, the scientific evidence 
underlying the risk assessments conducted by JECFA has probative value as to the sufficiency of the 
scientific evidence needed to perform an assessment  of risks in relation to the five hormones;  
however, it was by no means dispositive of that qu estion, in particular where a WTO Member has 
elected to adopt an SPS measure that does not conform to the international standard.  
712. For these reasons, we reverse  the Panel's finding that, where international standards exist, 
"there must be a  critical mass  of new evidence and/or informa tion that calls into question the 
fundamental precepts of previous knowledge and evidence so as to make relevant, previously 
sufficient, evidence now insufficient" within the meaning of Article 5.7.1442 
4. The Panel's Allocation of the Burden of Proof under Article 5.7 of the  SPS 
Agreement  
713. We turn now to the European Communities' clai m that the Panel erred by allocating to the 
European Communities the burden of demonstrati ng that Directive 2003/74/EC met the requirements 
of Article 5.7 of the  SPS Agreement in relation to the provisional ban on the five hormones at issue.  
The European Communities argues that, by limiting its re view to the "insufficiencies" in the scientific 
evidence identified by the European Communities, the Panel erroneously shifted to the European 
Communities the burden of proof under Article 5.7 of the  SPS Agreement .1443  In doing so, the
                                                      
1441Appellate Body Report, EC – Hormones , para. 102.  
1442Panel Report, US – Continued Suspension , para. 7.648;  Panel Report, Canada – Continued 
Suspension , para. 7.626.  (original emphasis) 
1443European Communities' appellant's submission, paras. 380-382. WT/DS321/AB/R 
Page 298  
 
European Communities  submits that the Panel misc onstrued Articles 5.1 and 5.7 to stand on a rule-
exception relationship
1444, even though Article 5.7 confers to WTO Members a "qualified right"1445 to 
take provisional measures under certain conditions.  In such circumstances, the United States and 
Canada should have borne the onus  of demonstrating that the cond itions provided under Article 5.7 
had not been met.1446   
714. In particular, the European Communities cha llenges the following statement by the Panel:  
Whereas, in the application of the burden of proof in relation to 
Article 5.7 of the SPS Agreement , it should be for the party 
challenging the applicability of Article 5.7 to make a prima facie case that the relevant scientific evidence regarding the five hormones is sufficient, it is also for the Europ ean Communities, in application of 
the principle that it is for each party to prove its allegations, to 
support its own allegations  with appropriate evidence.  This also has 
to be considered in the light of th e fact that, even though in this case 
the European Communities is the co mplainant, it also argues as part 
of its allegations under Article 22.8 of the DSU that its implementing 
measure complies with Article 5.7 of the  SPS Agreement.   Moreover, 
we recall the consequence of the pr esumption of consistency with the 
SPS Agreement and GATT 1994 of measures which conform to 
international standards, guidelines and recommendations on the risk assessments on which such measures  are based.  Since, in that 
context, the European Communities ar gues that the relevant scientific 
evidence is insufficient, we consid er that it is for the European 
Communities to identify the issu es for which such evidence is 
insufficient. 
Therefore, we do not consider that, as Panel, we have any obligation 
to go beyond the insufficiencies identified by the European 
Communities. ... we deem it appr opriate to limit our review 
exclusively to the "insufficien cies" expressly identified by the 
European Communities in its submissions to the Panel.
1447  (footnotes 
omitted) 
715. The United States and Canada assert that the Pa nel correctly allocated the burden of proof 
under Article 5.7 of the  SPS Agreement .1448  The United States and Canada point out that the Panel 
only shifted the burden of proof to the European  Communities once it was satisfied that the United 
States and Canada had sufficiently refuted the European Communities' allegation of compliance 
through positive evidence of a breach of Article 5.7.1449  Canada argues that the Panel correctly 
                                                      
1444European Communities' appellant's submission, para. 362. 
1445Ibid., para. 368.   
1446Ibid., para. 379. 
1447Panel Report, US – Continued Suspension , paras. 7.652 and 7.653;  Panel Report, Canada – 
Continued Suspension , paras. 7.629 and 7.630.  
1448United States' appellee's submission, para. 98;  Canada's appellee's submission, para. 115. 
1449United States' appellee's submission, para. 93;  Canada's appellee's submission, para. 115.  WT/DS321/AB/R 
 Page 299 
 
 
identified Article 5.7 as a "qualified exemption" to Article 2.21450, while the United States dismisses as 
speculative the European Communities'  contention that the Panel treated Article 5.7 as an exception to 
Article 5.1.1451  
716. In section IV.E, we explained how we see the allocation of the burden of proof in a post-
suspension situation in which the parties disagr ee as to whether an implementing measure brings 
about substantive compliance. The European Comm unities had to provide a clear description of its 
implementing measure, and an adequate explana tion regarding how this measure rectifies the 
inconsistencies found in the original proceedings.  We recall that the definitive import ban that was 
the subject of  EC – Hormones  and found to be inconsistent with Article 5.1 has been replaced, under 
Directive 2003/74/EC, by a provisional ban relating to the five other hormones.  The import ban 
applies to the same products: meat from cattle treated with progesterone, testosterone, trenbolone 
acetate, zeranol and MGA.  The European Communiti es replaced the original definitive ban with a 
provisional ban and invoked Article 5.7 as an altern ative justification to Article 5.1.  Thus, the 
European Communities had to provide an adequate  explanation of how the provisional ban taken 
under Article 5.7 rectifies the inconsistencies found in EC – Hormones .  Such explanation had to 
include, inter alia , an identification of the insufficiencies in the relevant scientific evidence that 
precluded the European Communities from performi ng a sufficiently objective risk assessment.  
Accordingly, we do not consider that the Panel e rred by limiting its review to the insufficiencies 
identified by the European Communities. 
717. Having said that, we referred above1452 to the Panel's discussion of how it would allocate the 
burden of proof for purposes of its analysis under Articles 5.1 and 5.7 of the  SPS Agreement  and we 
identified several flaws in the Panel's approach, whic h we need not repeat here.  We also explained 
how the Panel should have allocated the burden of proof in relation to the European Communities' 
contention that Directive 2003/74/EC meets the re quirements of Articles 5.1 and 5.7 of the  SPS 
Agreement.   To the extent that the Panel did not allocate  the burden of proof in its analysis of whether 
Directive 2003/74/EC met the requirements of Article 5.7 of the  SPS Agreement  according to the 
principles outlined above, we find that the Panel has erred.   
718. Accordingly, we find  that the Panel erred in the allocation of the burden of proof in its 
examination of the consistency of Direc tive 2003/74/EC with Article 5.7 of the  SPS Agreement.  
                                                      
1450Canada's appellee's submission, para. 112. 
1451United States' appellee's submission, para. 96. 
1452See supra , para. 579. WT/DS321/AB/R 
Page 300  
 
5. The Panel's Application of Article 5.7 of the  SPS Agreement
 
719. We turn finally to the European Communities'  claim that the Panel incorrectly applied 
Article 5.7 of the  SPS Agreement.   On appeal, the European Co mmunities asserts that the Panel 
"systematically downplay[ed]"1453 and ignored "highly rele vant scientific evidence"1454 which "go[es] 
against the evaluations of the JECFA or support th e position of the European Communities and that in 
fact the scientific evidence  was indeed insufficient"1455 to perform a risk assessment, particularly in 
the following areas:  (a) effects of hormones on certain population groups;  (b) dose response;  
(c) bioavailability;  (d) long late ncy periods for cancer and conf ounding factors;  and (e) adverse 
effects on growth and reproduction.1456  The European Communities al so points to several errors 
committed by the Panel when determining whether th e evidence concerning the risks posed by each of 
the five hormones individually was insufficient  to conduct a risk assessment under Article 5.7.1457 
720. The United States responds that the scientific ev idence on record, including the statements of 
the experts, support the conclusion that the releva nt scientific evidence on the five hormones is and 
remains sufficient to c onduct a risk assessment.1458  Canada argues that the European Communities' 
allegations are without merit, and considers that  the Panel properly weighed the scientific evidence 
before it. 1459   
721. As we noted in subsection 3, the Panel's "c ritical mass" test imposed an excessively high 
threshold in terms of the change in the scientific  evidence that would make previously sufficient 
evidence insufficient.  Rather than  requiring that the new evidence call into question the relationship 
between the body of scientific evidence and the conc lusions concerning risk, the Panel's test required 
a paradigm shift to the extent the evidence needed to call into question the "fundamental precepts of 
previous knowledge and evidence" on the five hormon es.  This erroneous threshold led the Panel to 
fail to attribute significance to evidence that c ould cast doubt as to whether the relevant scientific 
evidence still permits of a sufficiently objective asse ssment of risk.  One such example is the Panel's 
analysis of the European Communities' contention th at the relevant scientific  evidence concerning the 
effects of the hormones on certain categories of the population, in pa rticular pre-pubertal children, 
was "insufficient" within the meaning of Article 5.7 of the  SPS Agreement.   
                                                      
1453European Communities' appellant's submission, para. 427.  
1454Ibid., para. 447.  
1455Ibid., para. 427.  
1456Ibid., paras. 430-436.  
1457Ibid., paras. 437-447.  
1458United States' appellee's submission, para. 81. 
1459Canada's appellee's submission, para. 130.  WT/DS321/AB/R 
 Page 301 
 
 
722. Before the Panel, the Europ ean Communities argued that the development of more sensitive 
detection methods had identified lowe r endogenous levels of oestradiol  in pre-pubertal children than 
previously assumed by the detection method referred to in JECFA's risk assessments.  According to 
the European Communities, this suggested that indi viduals that have the lo west endogenous levels of 
sex hormones, such as pre-pubertal children and post -menopausal women, might be at an increased 
risk for adverse health effects that might be associated with exposure to exogenous sources of both 
oestrogens and testosterone.1460   
723. The new detection method was examined in a scientific study conducted by Klein et al. 
(1994), and was reviewed by the European Communities in the 1999 Opinion.  The Panel described 
the Klein study, and the conclusions the Eur opean Communities derived from it, as follows:  
The 1999 Opinion specifies that the hormone levels on which it relies 
were determined by radio-immunoassays (RIA) and that the use of these assays has frequently been associated with production of 
variable results, particularly when  used to detect low levels of 
endogenous hormones.  The 1999 Opinion notes that Klein et al. (1994) developed an ultrasensitive assay (100-fold more sensitive 
than RIAs) which identified values of oestradiol considerably lower 
than the range of oestradiol levels found through RIAs for prepubertal children.
1461  (footnote omitted) 
724. In its analysis, the Panel recalled its earlier finding that, in order to determine that the 
evidence on the five hormones was "ins ufficient" within the meaning of Article 5.7, there must be "a 
critical mass of new evidence and/or information that  calls into question the fundamental precepts of 
knowledge and evidence so as to make relevant, prev iously sufficient, evidence now insufficient."1462  
On this basis the Panel concluded that its task w as to examine "whether th e more sensitive detection 
methods which identified lower horm onal levels in prepubertal child ren than thought until now are 
such as to call into question the range of physiologi cal levels of the sex hormones in humans currently 
believed to exist."1463  The Panel referred to Dr. Sippell's testimony, which characterized the 
development of ultra-sensitive detection methods  as a "quantum leap in [oestrogen] assay 
methodology"1464  The Panel noted Dr. Sippell's statement that "[t]he risk to children arising from 
hormones that are naturally present in meat as comp ared to residues of hormonal growth promoters 
                                                      
1460See Panel Report, US – Continued Suspension , para. 7.664;  and Panel Report, Canada – Continued 
Suspension , para. 7.641.   
1461Panel Report, US – Continued Suspension , para. 7.665;  Panel Report, Canada – Continued 
Suspension , para. 7.642.  
1462Panel Report, US – Continued Suspension , para. 7.666;  Panel Report, Canada – Continued 
Suspension , para. 7.643.  
1463Ibid. 
1464Panel Report, US – Continued Suspension , para. 7.667;  Panel Report, C anada  – Continued 
Suspension , para. 7.644 (quoting replies of the scientific experts to Question 40 posed by the Panel, Panel 
Reports, Annex D, para. 328).  WT/DS321/AB/R 
Page 302  
 
has, to my knowledge, been estimated for [oestradiol-17 β] only".
1465  The Panel then observed that 
the 2000 Opinion stated that such new detection methods had not been validated1466, and quoted 
Dr. Boobis' opinion questioning the validity of the new study presented by the European 
Communities.1467  On this basis, the Panel concluded that:  
We note that the evidence presented relates only to oestradiol, but 
that the claim we are examining with  regard to the insufficiencies of 
the evidence are with respect to the five other hormones at issue, not 
oestradiol.  We note furthermore that the 2002 Opinion concludes 
that these more sensitive detection methods have not yet been 
validated.  
On the basis of the above, we ar e not convinced that the studies 
discussed by the experts call into question the fundamental precepts of previous knowledge and eviden ce so as to make relevant, 
previously sufficient evidence now insufficient in relation to the 
effect of the five hormones on pre-pubertal children.  Particularly, it has not been established that the data regarding the effects of hormones on which the JECFA assessments are based are insufficient in light of new evidence relating to the other five hormones at issue.
1468  
725. In concluding that it is "not convinced" that the ultra-sensitive assay study referred to by the 
European Communities "call[s] into question the fundamental precepts of previous knowledge" in 
relation to the effect of the five hormones on pre- pubertal children, the Panel applied an excessively 
high threshold in relation to the new scientific evidence which is required to render previously 
sufficient scientific evidence "insuffi cient" within the meaning of Artic le 5.7.  Irrespective of whether 
the Panel was itself persuaded by the Klein study, the Panel erred to the extent that it considered that a 
paradigmatic shift in the scientific knowledge was re quired in order to render the scientific evidence 
relied by JECFA now "insufficient" within the meaning of Article 5.7.  The "insufficiency" requirement in Article 5.7 does not imply that ne w scientific evidence must entirely displace the 
scientific evidence upon which an international sta ndard relies.  It suffices that new scientific 
developments call into question whether the body of  scientific evidence still permits of a sufficiently 
objective assessment of risk.  
                                                     
 
1465Panel Report, US – Continued Suspension , para. 7.668;  Panel Report, C anada  – Continued 
Suspension , para. 7.645 (quoting replies of the scientific experts to Question 41 posed by the Panel, Panel 
Reports, Annex D, para. 335).  
1466Panel Report, US – Continued Suspension , para. 7.669;  Panel Report, C anada  – Continued 
Suspension , para. 7.646 (referring to 2000 Opinion, p. 3).  
1467Ibid. (referring to replies of the scientific experts to  Question 40 posed by the Panel, Panel Reports, 
Annex D, paras. 325 and 326).  
1468Panel Report, US – Continued Suspension , paras. 7.670 and 7.671;  Panel Report, C anada  – 
Continued Suspension , paras. 7.647 and 7.648.   WT/DS321/AB/R 
 Page 303 
 
 
726. The Panel seemed to rely on two pieces of eviden ce in coming to the conclusion that the ultra-
sensitive detection method discussed in the Klein study had not yet been validated:  a statement to that 
effect in the 2002 Opinion1469, and the testimony of Dr. Boobis, who questioned the validity of the 
Klein study.1470  However, the Panel record shows that at least some of the scientific experts 
considered that the Klein study could possibly cast doubt as to whether the body of scientific evidence 
relied on by JECFA still permitted of a sufficiently objective assessment of risks posed by the five 
hormones in relation to pre-pubertal children.   
727. Dr. Sippell seemed to agree with the Europ ean Communities' position that the relevant 
scientific evidence on the effects of hormones in pr e-pubertal children was not "sufficient" to conduct 
a risk assessment under Article 5.1.  Dr. Sippell ob served that "[w]e just don't have yet everywhere 
where it would be necessary the methodology, the analytical tools to m easure as sensitively as we 
should do it, and therefore I think that the data available are insufficient."1471  Dr. Sippell also 
explained that: 
... it is difficult to calculate the exact [hormone] production rates in 
prepubertal children. ... [JECFA va lues] have been based on the, so 
to speak, traditional levels measured by radio immuno assays, and usually by radio immuno assays without prior extraction.  We all 
know that the sensitivity of such procedures is not enough compared 
with more modern techniques ... the extractive procedures involving radio immuno assays, but even more modern molecular base techniques like recombinant cell bioassays, of oestrogen, oestradiol or oestrogen activity.  And these ... are significantly below the levels 
previously thought, and by that the production rate is now 
significantly lower.  And this of course implies that any risk from 
exogenous sources, for example, beef treated with hormones, treated with oestradiol-17 β, is much higher.
1472  
728. Dr. De Brabander concurred, stating that "I ca nnot say that the [JECFA] data are bad ... I just 
say you don't know that they are good, and you ha ve to check them with modern analytical 
methods."1473  Dr.  Guttenplan espoused a similar view , noting that "more accurate methods of 
analysis could now be used to measure the effect  of eating hormone-treated beef on blood levels of 
estrogen in children and post-menopausal women."1474  He also observed that "in boys the [oestrogen] 
                                                      
1469Panel Report, US – Continued Suspension , para. 7.670;  Panel Report, Canada – Continued 
Suspension , para. 7.647 (referring to 2002 Opinion, para. 4.4.1, para. 9).  
1470Panel Report, US – Continued Suspension , para. 7.669;  Panel Report, Canada – Continued 
Suspension , para. 7.646 (quoting replies of the scientific experts to Question 40 posed by the Panel, Panel 
Reports, Annex D, paras. 325 and 326).  
1471Transcript of the Panel's joint meeting with scientific experts on 27-28 September 2006, Panel 
Reports, Annex G, para. 891.  
1472Ibid., para. 557.  
1473Ibid., para. 675.  
1474Replies of the scientific experts to Question 52  posed by the Panel, Panel Reports, Annex D, 
para. 413.  WT/DS321/AB/R 
Page 304  
 
levels are even lower, and there I think we have to worry about developmental effects ... I still think 
that these could be investigated epidemiologically or in or some type of study.  We might ... need a 
surrogate, perhaps saliva or urine, but I think it is perhaps the most important issue to address is the 
sensitivity of children."
1475 
729. Dr. Boobis, who as the Panel noted questioned the validity of the ultra-sensitive recombinant 
assay used in the Klein study, also testified that th e levels of oestradiol endogenously produced in pre-
pubertal children may be lower than previously th ought.  In response to direct questioning by the 
United States, Dr. Boobis explained that:  
.... having looked at these data is that, first of all, the recombinant 
assay has not yet been validated adequately, but secondly there is evidence, when one looks at these data , to suggest that the circulating 
levels of oestradiol in male ch ildren are lower than previously 
thought, I would accept that, but I would not think they are as low as in the original publication by Klein et al , because there have been 
numerous publications since then using a variety of assays which suggest that the levels are certainly higher than those very low levels 
first reported.
1476 
730. Although the Panel was correct in observing that  the Klein study only examined endogenous 
levels of oestradiol, lower leve ls of endogenous production of horm ones in humans played a key role 
in the European Communities' conclusion that no safe threshold level or ADI could be established for any of the six hormones assessed.  The 1999 Opinion st ates that, in the light of "uncertainties in the 
estimates of endogenous hormone pr oduction rates and metabolic cleara nce capacity, particularly in 
prepubertal children, no threshold level and theref ore no ADI can be established for any of the [six] 
hormones."
1477  For this reason, the Panel should have expl ored further the question of what relevance, 
if any, the study relied on by the European Communities examining endogenous levels of oestradiol could have in relation to potentia l adverse health effects relating to the other five hormones.  During 
the course of the oral hearing, the European Comm unities argued that some scientists agree with its 
position that measurements of the endogenous levels of natural horm ones are relevant for synthetic 
hormones that share similar toxicological properties and effects. 
                                                     
 
1475Transcript of the Panel's joint meeting with scientific experts on 27-28 September 2006, Panel 
Reports, Annex G, para. 1061.  
1476Ibid., para. 572.   
14771999 Opinion, pp. 72 and 73.  The 1999 Opinion also concludes that: "For all six hormones 
endocrine, developmental, immunological, neurobioloical, immunotoxic, genotoxic, and carcinogenic effects 
could be envisaged.  Of the various susceptible risk groups, prepubertal children is the group of greatest 
concern.  Again the available data do not enable a quantitative estimate of the risk".    WT/DS321/AB/R 
 Page 305 
 
 
731. In sum, the Panel erred in its interpretati on and application of Article 5.7 of the  SPS 
Agreement   by adopting an incorrect legal test to assess the European Communities' explanations 
concerning the insufficiencies in the relevant scientific evidence.   
732. The European Communities argu es further that the Panel fa iled to conduct an objective 
assessment of the facts of the case, as required by  Article 11 of the DSU, in its analysis under 
Article 5.7.  Having determined that the Panel inco rrectly interpreted and app lied Article 5.7 of the  
SPS Agreement , we do not find it necessary to address the European Communities' claim that the 
Panel acted inconsistently with Article 11 of the DSU. 
F. Conclusions 
733. We found above that the Panel drew too rigi d a distinction between the chosen level of 
protection and the "insufficiency" of the releva nt scientific evidence under Article 5.7 of the  SPS 
Agreement .1478  We also reversed  the Panel's finding that, where international standards exist, a 
"critical mass of new evidence and/or information th at calls into question the fundamental precepts of 
previous knowledge and evidence" is required to re nder the relevant scientific evidence "insufficient" 
within the meaning of Article 5.7.1479  We found, moreover, that the Panel erred in the allocation of 
the burden of proof.1480  Finally, we found that the Panel incorrectly interpreted and applied 
Article 5.7 in determining whether the relevant sci entific evidence in relation to the five hormones 
was "insufficient" within the meaning of that provision.1481  In addition, we have found that the 
Panel's analysis was compromised because its cons ultations with Drs. Boisseau and Boobis infringed 
the European Communities' due process rights.1482 
734. In the light of these errors, we reverse  the Panel's finding that "it has not been demonstrated 
that relevant scientific evidence was insufficien t, within the meaning of Article 5.7 of the 
SPS Agreement , in relation to any of the five hormon es with respect to which the European 
Communities applies a provisional ban."1483  As a consequence of its finding, the Panel also 
concluded that "the [European Communities'] comp liance measure does not meet the requirements of 
Article 5.7 of the  SPS Agreement  as far as the provisional ban on pr ogesterone, testosterone, zeranol, 
trenbolone acetate and melengestrol acetate is concerned."1484  Because it is premised on the Panel's 
                                                      
1478See supra , para. 686.  
1479See supra , para. 712.  
1480See supra , para. 718.  
1481See supra , para. 731.  
1482See supra , section V. 
1483Panel Report, US – Continued Suspension , para. 7.835;  Panel Report, Canada – Continued 
Suspension , para. 7.821. 
1484Panel Report, US – Continued Suspension , para. 7.836;  Panel Report, Canada – Continued 
Suspension , para. 7.822. WT/DS321/AB/R 
Page 306  
 
earlier finding concerning the "insufficiency" of the relevant scientific info rmation, which we have 
reversed, the Panel's conclusion cannot stand.   
735. Given the numerous flaws that we identified in the Panel's analysis, and the highly contested 
nature of the facts, we do not consider it possibl e to complete the analysis.  Thus, we make no 
findings on the consistency or in consistency of the European Co mmunities' provisional SPS measure 
relating to progesterone, testosterone , zeranol, trenbolone acetate and MGA. 
VIII.  Findings and Conclusions 
736. For the reasons set out in this Report, the Appellate Body: 
(a) As regards the DSU: 
(i) finds
 that the Panel did not err in statin g that proceedings under Article 21.5 
of the DSU are open to not only the original complainant1485, because they 
may be initiated by original complainants and original respondents; 
(ii) upholds  the Panel's finding that "it has jurisdiction to consider the 
compatibility of the [European Communities'] implementing measure with the  SPS Agreement  as part of its review of the claim raised by the European 
Communities with respect to Article 22.8 of the DSU"
1486; 
(iii) because it has not been established that the measure found to be inconsistent 
with the  SPS Agreement  in the EC – Hormones  dispute has been 
removed1487, upholds  the Panel's finding that "the European Communities has 
not established a violation of Articles 23.1 and 3.7 of the DSU  as a result of 
a breach of Article 22.8 "1488; 
(iv) reverses  the Panel's finding that, "by maintaining its suspension of 
concessions even after the notification of [Directive 2003/74/EC]", Canada is "seeking redress of a violation with resp ect to [this Directive], within the 
meaning of Article 23.1 of the DSU"
1489;  and 
                                                      
1485Panel Report, Canada – Continued Suspension , para. 7.353. 
1486Ibid., para. 7.376. 
1487See subparagraphs (c) and (d) infra . 
1488Panel Report, Canada – Continued Suspension , para. 7.842(b). (original emphasis) 
1489Ibid., para. 7.207.  See also ibid., para. 7.891(a).  WT/DS321/AB/R 
 Page 307 
 
 
(v) reverses  the Panel's findings that Canada "made a 'determination' within the 
meaning of Article 23.2(a) in relati on to Directive 2003/74/EC" on the basis 
of statements made at DSB meetings and the fact that the suspension of 
concessions continued subsequent to the notification of Directive 2003/74/EC
1490, and that Canada "failed to make any such 
determination consistent with the findin gs contained in the panel or Appellate 
Body report adopted by the DSB or an  arbitration award rendered under the 
DSU", in breach of Article 23.2(a).1491  
(b) As regards the Panel's consultations  with the scientific experts, finds  that the Panel 
infringed the European Communities' due process rights, because the institutional 
affiliation of Drs. Boisseau and Boobis compromised their appointment and thereby 
the adjudicative independence and impartiality of the Panel.  Accordingly, the Panel 
failed to comply with its duties under Article 11 of the DSU. 
(c) As regards the consistency with Article 5.1 of the  SPS Agreement  of the European 
Communities' import ban on meat from cattle treated with oestradiol-17 β for growth-
promotion purposes, which is applie d pursuant to Directive 2003/74/EC: 
(i) finds  that the Panel erred in its interpreta tion and application of Article 5.1 in 
relation to risks of misuse and abuse in the administration of hormones to cattle for growth-promotion purposes; 
(ii) finds
 that the Panel did not err in requiring the European Communities to 
evaluate specifically the risks arising from the presence of residues of oestradiol-17 β in meat or meat products from cattle treated with the hormone 
for growth-promotion purposes; 
(iii) finds
 that the Panel did not err in its  interpretation of Article 5.1 and 
paragraph 4 of Annex A of the  SPS Agreement  as regards quantification of 
risk; 
(iv) finds  that the Panel erred in the alloca tion of the burden of proof in its 
assessment of the consistency of Direc tive 2003/74/EC with Article 5.1 of the 
SPS Agreement ; 
                                                      
1490Panel Report, Canada – Continued Suspension , para. 7.232.  See also ibid., para. 7.841(b). 
1491Ibid., para. 7.237. (emphasis omitted)  See also ibid., para. 7.841(b). WT/DS321/AB/R 
Page 308  
 
(v) finds
 that the Panel applied an incorrect standard of review in examining 
whether the European Communities'  risk assessment satisfied the 
requirements of Article 5.1 and pa ragraph 4 of Annex A of the  SPS 
Agreement , and thereby failed to comply with its duties under Article 11 of 
the DSU;  and 
(vi) reverses  the Panel's finding that the European Communities' import ban 
relating to oestradiol-17 β is not based on a risk assessment as required by 
Article 5.1 of the  SPS Agreement1492;  however, the Appella te Body is unable 
to complete the analysis and ther efore makes no findings as to the 
consistency or inconsistency of the import ban relating to oestradiol-17 β  
with Article 5.1 of the  SPS Agreement . 
(d) As regards the consistency with Article 5.7 of the  SPS Agreement  of the European 
Communities' provisional import ban on meat  from cattle treated with testosterone, 
progesterone, trenbolone acetate, zeranol, and MGA, for growth-promotion purposes, which is applied pursuant to Directive 2003/74/EC:  
(i) reverses
 the Panel's finding that "the determination of whether scientific 
evidence is sufficient to assess the existe nce and magnitude of a risk must be 
disconnected from the intended level of protection"1493; 
(ii) reverses  the Panel's finding that, where intern ational standards exist,  "there 
must be a  critical mass  of new evidence and/or information that calls into 
question the fundamental precepts of pr evious knowledge and evidence so as 
to make relevant, previously su fficient, evidence now insufficient"1494; 
(iii) finds  that the Panel erred in the alloca tion of the burden of proof in its 
examination of the consistency of Dir ective 2003/74/EC with Article 5.7 of 
the  SPS Agreement ; 
(iv) finds  that the Panel erred in its interpreta tion and application of Article 5.7 of 
the  SPS Agreement   by adopting an incorrect legal test in determining 
whether the relevant scientifi c evidence was "insufficient";  
                                                      
1492Panel Report, Canada – Continued Suspension , paras. 7.541, 7.548 and 7.549. 
1493Ibid., para. 7.590. 
1494Ibid., para. 7.626. (original emphasis; footnote omitted)  WT/DS321/AB/R 
 Page 309 
 
 
(v) does not find it necessary to address th e European Communities' claim that 
the Panel acted inconsistently with Article 11 of the DSU;  and  
(vi) reverses  the Panel's finding that the provisional import ban relating to 
testosterone, progesterone, trenbolone acetate, zeranol, and MGA does not meet the requirements of Article 5.7 of the  SPS Agreement
1495;  however, the 
Appellate Body is unable to complete the analysis and therefore makes no 
findings as to the consistency or incons istency of the European Communities' 
provisional import ban with Article 5.7 of the  SPS Agreement . 
737. Because we have been unable to complete th e analysis as to whether Directive 2003/74/EC 
has brought the European Comm unities into substantive complia nce within the meaning of 
Article 22.8 of the DSU, the recommendations and rulings adopted by the DSB in EC – Hormones  
remain operative.  In the light of the obliga tions arising under Article 22.8 of the DSU, we 
recommend that the Dispute Settlement Body requ est Canada and the European Communities to 
initiate Article 21.5 proceedings without delay in or der to resolve their disagreement as to whether the 
European Communities has removed the me asure found to be inconsistent in EC – Hormones  and 
whether the application of the suspension of concessions by Canada remains legally valid. 
                                                      
1495Panel Report, Canada – Continued Suspension , paras. 7.821 and 7.822. WT/DS321/AB/R 
Page 310  
 
Signed in the original in Geneva this 19th day of September 2008 by:  
 
    
_________________________ 
David Unterhalter 
Presiding Member 
 
 
 
  
 _________________________ _________________________ 
 Georges Abi-Saab Lilia Bautista 
 Member Member 
 
 
  WT/DS321/AB/R 
 Page 311 
 
 
ANNEX I 
 
 WORLD TRADE  
ORGANIZATION  WT/DS320/12 
WT/DS321/12 
2 June 2008 
 (08-2559) 
 Original:   English 
  
UNITED STATES – CONTINUED SUSPENSION OF OBLIGATIONS IN THE 
EC – HORMONES DISPUTE 
 
CANADA – CONTINUED SUSPENSION OF OBLIGATIONS IN THE 
EC – HORMONES DISPUTE 
 
Notification of an Appeal by the European Communities
 
under Article 16.4 and Article 17 of the Understanding on Rules  
and Procedures Governing the Settlement of Disputes (DSU),  
and under Rule 20(1) of the Working Procedures for Appellate Review  
   The following notification, dated 29 May 2008, from the Delegation of the European 
Commission, is being circulated to Members. 
 
_______________ 
 
 
 Notification of an Appeal by the European Communities under Article 16.4 and Article 17 of 
the Understanding on Rules and Procedures  Governing the Settlement of Disputes (DSU), and under 
Rule 20.1 of the Working  Procedures for Appellate Review . 
 1. Pursuant to Article 16.4 and Article 17 of the DSU and to Rule 20.1 of the Working 
Procedures for Appellate Review , the European Communities submits its Notice of Appeal on certain 
issues of law covered in the Reports of the Panels in DS320, United States – Continued Suspension of 
Obligations in the EC – Hormones  Dispute  and DS321, Canada – Continued Suspension of 
Obligations in the EC – Hormones  Dispute  and certain legal interpretati ons developed by the Panels 
in those Reports. 
2. The European Communities seeks review by the Appellate Body of the following errors of 
law and legal interpretation containe d in the Reports of the Panels: 
(a)  The Panels incorrectly interpreted and app lied the words "recourse to dispute settlement in 
accordance with the rules and procedures of th is Understanding" in Article 23.2(a) of the 
DSU in the presence of an implementation measure in a post-retaliation situation.  This is due 
principally to the Panels' incorrect interpreta tion of Article 21.5 of the DSU.  The Panels' 
errors are contained in particular in paragra phs 7.246 to 7.249 and 7.346 to 7.359 of the Panel 
Report in DS320 and paragraphs 7.239 to 7.242 and 7.344 to 7.357 of the Panel Report in 
DS321. 
(b)  The Panels erred in failing to make a proper finding of violation of Article 23.1 read together 
with Article 22.8 and 3.7 of the DSU when stating that "to the extent the measure found to be WT/DS321/AB/R 
Page 312  
 
inconsistent with the SPS Agreement  in the EC – Hormones dispute … has not been removed 
by the European Communities, [the United States and Canada] have not breached Article 22.8 
of the DSU; and to the extent that Artic le 22.8 has not been breached, the European 
Communities has not established a violation of Articles 23.1 and 3.7 of the DSU as a result of a breach of Article 22.8". This error is due  to the Panels' incorrect interpretation of 
Article 22.8 of the DSU and in particular the words "the measure found to be inconsistent 
with a covered agreement has been removed"  therein.  The Panels' conclusion and the 
corresponding reasoning are contained in paragr aphs 7.857 and 7.252 to  7.386 of the Panel 
Report in DS320 and paragraphs 7.842 and 7.2 45 to 7.383 of the Panel Report in DS321. 
(c)  The Panels went beyond their terms of reference and assumed the function of Article 21.5 
DSU panels contrary to Articles 7 and 21.5 of the DSU.  This appears in particular in 
paragraph 8.3 of the two Pane l Reports and paragraphs 7.1 50 to 7.182, 7.270 to 7.291 
and 7.360 to 7.379 of the Panel Report in DS320 and paragraphs 7.137 to 7.164, 7.286 
to 7.307 and 7.358 to 7.376 of the Panel Report in DS321. 
(d)  The Panels failed to respect the fundament al principle of due process when selecting and 
taking the advice of scientific experts under Articles 13.2 of the DSU and 11.2 of the SPS 
Agreement  with the result that the Panels failed to  make an objective assessment of the matter 
before them in breach of Article 11 of the DSU.  This appears in particul ar in paragraphs 7.55 
to 7.99 and 6.21 to 6.25 and the subsequent analysis of the Panel under the SPS Agreement  in 
paragraphs 7.387 to 7.846 of the Panel Report in DS320 and paragraphs 7.53 to 7.96 and the 
subsequent analysis of the Panel under the SPS Agreement  in paragraphs 7.384 to 7.831 of the 
Panel Report in DS321. 
(e)  The Panels failed to correctly determine and apply the standard of review under in particular 
Articles 5.1 and 5.7 of the SPS Agreement  in breach thereof and in breach of Article 11 of the 
DSU.  The Panels seriously mischaracterised and misinterpreted the evidence on which the 
European Communities based itself and conducted a de novo  review of the matter before them 
and inter alia  failed to take into account or properly evaluate the scientific basis of the 
European Communities' measure.  They also faile d to attach proper legal relevance to genuine 
uncertainties and scientific controversies on the matter before them and arbitrarily chose 
between the opinions of their experts and those pr esented by the other parties to the disputes.  
The Panels also relied incorrectly on the opinion s of Codex Alimentarius and JECFA.  This 
appears inter alia  in paragraphs 7.412 to 7.427 and pa ragraphs 7.435 to 7.846 of the Panel 
Report in DS320 and paragraphs 7.403 to 7.418 and paragraphs 7.426 to 7.831 of the Panel 
Report in DS321. 
(f)  The Panels failed to correctly determine and apply the burden of proof under the SPS 
Agreement and in particular Articles 5.1 and 5.7 thereof .  The Panels imposed the burden of 
proof on the European Communities to prove the consistency of its measure with the SPS 
Agreement  and in particular Articles 5.1 and 5.7 thereof.  This appears in particular in 
paragraphs 7.380 to 7.386 and pa ragraphs 7.435 to 7.846 of the Panel Report in DS320 and 
paragraphs 7.377 to 7.383 and paragraphs 7.426 to 7.831 of the Panel Report in DS321. 
(g)  The Panels incorrectly interpre ted and applied Article 5.1 of the SPS Agreement  and failed to 
make an objective assessment of the matter before them in breach of Article 11 of the DSU.  The Panels erroneously adopted an overly restri ctive notion of "an assessment, as appropriate 
to the circumstances, of the risk" under Article 5.1 of the SPS Agreement as informed by 
Article 5.2 thereof, ignored that the EC ri sk assessments had focussed on and addressed the 
particular risk at stake and required that th e risk be quantified.  The Panels' erroneous 
assessments arose out of its application of an in appropriate standard of review, as set out in 
paragraph (e) above.  In particular, it arbitrarily chose between the opinions of their scientific 
experts in their review of the matter before  them.  This appears in particular in  WT/DS321/AB/R 
 Page 313 
 
 
paragraphs 7.435 to 7.579 of the Panel Report in  DS320 and paragraphs 7.426 to 7.549 of the 
Panel Report in DS321.  
(h)  The Panels incorrectly interpre ted and applied Article 5.7 of the SPS Agreement  and failed to 
make an objective assessment of the matter before them in breach of Article 11 of the DSU.  The Panels incorrectly interpreted the relationshi p of Article 5.7 with the other provisions of 
the SPS Agreement  and in particular Articles 3.2, 3.3 and 5.1 thereof and adopted and applied 
an erroneous criterion of critical mass of new scientific evidence and/or information for the 
purposes of applying Article 5.7.  The Pa nels' erroneous assessments arose out of its 
application of an inappropriate standard of review, as set out in pa ragraph (e) above.  In 
particular, it arbitrarily chose between the opinions  of its scientific experts in their review of 
the matter before them.  This appears in particul ar in paragraphs 7.580 to 7.837 of the Panel 
Report in DS320 and paragraphs 7.550 to  7.823 of the Panel Report in DS321. 
(i)  The Panels erred in making a suggestion that insufficiently clarifies the implications of their 
findings contrary to Article 3.7 and 19.1 of the DSU.  This appears in particular in paragraphs 8.2 and 8.3 of the Panel Reports. 
 
_______________ 
 
 WT/DS321/AB/R 
Page 314  
 
ANNEX II 
 
 WORLD TRADE  
ORGANIZATION  WT/DS320/13 
16 June 2008 
 (08-2784) 
 Original:   English 
  
UNITED STATES – CONTINUED SUSPENSION OF OBLIGATIONS IN THE 
EC – HORMONES DISPUTE 
 
Notification of an Other Appeal by the United States
 
under Article 16.4 and Article 17 of the Understanding on Rules  
and Procedures Governing the Settlement of Disputes (DSU),  
and under Rule 23(1) of the Working Procedures for Appellate Review  
 
   The following notification, dated 10 June 2008, from the Delegation of the United States, is being circulated to Members.  
_______________ 
 
Pursuant to Article 16 of the Understanding on Rules and Procedures Governing the 
Settlement of Disputes ("DSU") and Rule 23 of the Working Procedures for Appellate Review , the 
United States hereby notifies its decision to appeal  to the Appellate Body certain issues of law 
covered in the Report of the Panel on United States – Continued Suspension of Obligations in the 
EC – Hormones Dispute  (WT/DS320/R) ("Panel Report") and certa in legal interpretations developed 
by the Panel.  1. The United States seeks review by the Appellate  Body of the Panel's legal conclusion that the 
United States breached Article 23.1 of the DSU (e.g ., Panel Report, paras. 7.250, 7.856(a)).  This 
conclusion is in error and is based on erroneous fi ndings on issues of law and legal interpretations, 
including the Panel's findings that, by maintaining its suspension of concessions after the notification 
by the European Communities ("EC") of Directive 2003/74/EC, the United States was seeking the redress of a violation of obligations under a c overed agreement without having recourse to, and 
abiding by, the rules and procedures of the DSU (e.g ., Panel Report, paras. 7.215, 7.856(a)), and the 
Panel's interpretation and understandi ng of the legal basis for the U.S. suspension of concessions (e.g., 
Panel Report, paras. 7.209-7.214).  2. The United States also seeks review of the Pa nel's conclusion that the United States breached 
DSU Article 23.2(a) (e.g., Panel Report, paras. 7.245,  7.856(b)).  This conclusion is in error and is 
based on erroneous findings on issues of law and le gal interpretations, including the Panel's findings 
that the United States made a determination to the effect that a violation had occurred without 
recourse to dispute settlement in accordance with the rules and procedures of the DSU (e.g., Panel 
Report, paras. 7.239, 7.856(b)), on the basis of U.S. statements made at the meetings of the Dispute 
Settlement Body on November 1 and December 7, 2003 (e.g., Panel Report par as. 7.223-7.230) and/or 
the continuation of the U.S. suspension of concessions after the EC's notification of 
Directive 2003/74/EC (e.g., Panel Report paras. 7.226, 7.230, 7.232).  WT/DS321/AB/R 
 Page 315 
 
 
3. The United States seeks review of the Panel's suggestion that the United States should have 
recourse to the rules and procedures of the DSU wi thout delay (e.g., Panel Report paras. 6.45, 8.3) 
and the Panel's conclusion that it was restricted from a direct determination of the compatibility of Directive 2003/74/EC with the covered agreements (e.g., Panel Report paras. 7.162-7.164, 7.360, 
7.855, 8.3).  The suggestion and conclusion are in error and based on erroneous findings on issues of 
law and related legal interpretati ons.  However, the Appellate Body would not need to review the 
suggestion and conclusion if it  reverses the Panel's findings an d conclusions on DSU Articles 23.1 
and 23.2(a). 
  
_______________ 
 
 WT/DS321/AB/R 
Page 316  
 
ANNEX III 
 
 WORLD TRADE  
ORGANIZATION  WT/DS321/13 
16 June 2008 
 (08-2783) 
 Original:   English 
  
CANADA – CONTINUED SUSPENSION OF OBLIGATIONS IN THE 
EC – HORMONES DISPUTE 
 
Notification of an Other Appeal by Canada
 
under Article 16.4 and Article 17 of the Understanding on Rules  
and Procedures Governing the Settlement of Disputes (DSU),  
and under Rule 23(1) of the Working Procedures for Appellate Review  
 
   The following notification, dated 10 June 200 8, from the Delegation of Canada, is being 
circulated to Members.  
_______________ 
 
 Pursuant to paragraph 4 of Article 16 of the Understanding on Rules and Procedures 
Governing the Settlement of Disputes (the "DSU") and paragra ph 1 of Rule 23 of the Working 
Procedures for Appellate Review , the Government of Canada here by submits its Notice of Other 
Appeal concerning certain other issues of law covered in the Panel Report on Canada – Continued 
Suspension of Obligations in the EC – Hormones Dispute  (WT/DS321/R) and certain legal 
interpretations developed by the Panel.   In the view of the Government of Canada, th e Panel erred in interpreting Article 23 of the 
DSU in isolation from Article 22.8 of the DSU a nd committed an error in law by applying, in 
particular, Article 23.1 and 23.2(a) of the DSU to th e situation of post-retaliation in this case.  These 
errors are contained in paragraphs 7.162 to 7.1 64, 7.189 to 7.244 and 7.841 of the Panel Report. 
  The Government of Canada is also of the view that the Panel erred in finding that by 
continuing to suspend concessions vis-à-vis  the European Communities following its notification to 
the Dispute Settlement Body of Directive 2003/74/ EC Canada was:  (i) seeking the redress of a 
violation of obligations under a covered agreement without having recourse to, and abiding by, the 
rules and procedures of the DSU in violation of Article 23.1 of the DSU; and (ii) making a determination to the effect that a violation had occurred without having recourse to dispute settlement 
in accordance with the rules and procedures of the DS U, in violation of Article 23.2(a) of the DSU.  
These errors are due to the Panel's misinterpretati on of the legal basis for Canada's suspension of 
concessions.  The Panel's findings and corresponding reasoning are contained in paragraphs 7.841 and 
7.189 to 7.244 of its report.   In the alternative, should the Appellate Body confirm the findings of the Panel in respect of 
DSU Article 23.1 and 23.2(a) in rela tion to Canada, the Government of  Canada submits that the Panel 
erred in stating that it did not have jurisdiction to determine the compatibility of Directive 2003/74/EC 
with the covered agreements and by making the suggestion that Cana da should have recourse to the  WT/DS321/AB/R 
 Page 317 
 
 
rules and procedures of the DSU without delay in order to implement its findings under Article 23 of 
the DSU.  These statements are contained in paragr aph 8.3 of the Panel Report and are contrary to 
Articles 3.3, 3.7, 19.2 and 22.8 of the DSU.   The Government of Canada respectfully request s the Appellate Body to reverse the findings 
and conclusions of the Panel referred to above a nd to modify accordingly the recommendations of the 
Panel.  
 
_______________ 
 
 WT/DS321/AB/R 
Page 318  
 
ANNEX IV –  
 
PROCEDURAL RULING OF 10 JULY TO ALLOW 
PUBLIC OBSERVATION OF THE ORAL HEARING 
 
10 July 2008 
  
United States – Continued Suspension of Ob ligations in the EC – Hormones Dispute 
AB-2008-5 
Canada – Continued Suspension of Obliga tions in the EC – Hormones Dispute 
AB-2008-6 
 
Procedural Ruling
 
 
 
1. On 3 June 2008, Canada, the European Co mmunities, and the United States each filed a 
request to allow public observation of the oral hearing in these proceedings.1  The participants argued 
that nothing in the Understanding on Rules and Procedures Governing the Settlement of Disputes  (the 
"DSU") or the Working Procedures for Appellate Review  (the " Working Procedures ") precludes the 
Appellate Body from authorizing public observation of the oral hearing.  On 4 June 2008, we invited 
the third participants to comment in writing on the requests of Canada, th e European Communities, 
and the United States.  In particular, we asked thir d parties to provide their views on the permissibility 
of opening the hearing under the DSU and the Working Procedures, and, if they so wished, on the 
specific logistical arrangements proposed in the requests.  We received comments on 12 June 2008 
from Australia, Brazil, China, India, Mexico, Ne w Zealand, Norway, and the Separate Customs 
Territory of Taiwan, Penghu, Kinmen , and Matsu.  Australia, New Zeal and, Norway, and the Separate 
Customs Territory of Taiwan, Penghu, Kinmen, and Matsu expressed their support for the request of 
the participants.  Brazil, China, India, and Me xico requested the Appellate Body to deny the 
participants' request.  According to these third participants, the or al hearing forms part of the 
proceedings of the Appellate Body and, therefore, is  subject to the requirement of Article 17.10 of the 
DSU that "[t]he proceedings of the Appellate Body shall be conf idential."  On 16 June 2008, we 
invited Canada, the European Communities, and the United States to comment on the submissions 
made by the third participants.  We also invited third participants who wish ed to do so to submit 
comments on the submissions made by the other third participants.  Additional comments from 
Canada, the European Communities, and the United St ates were received on 23 June 2008.  We held 
an oral hearing with the participants and third pa rticipants on 7 July 2008 exclusively dedicated to 
exploring the issues raised by the request of the par ticipants.  The participants and third participants 
were invited to submit by close of business, 8 July  2008, additional comments relating specifically to 
the technical modalities proposed by the particip ants for public observation.  Comments were 
received from Brazil, China, India, and Mexico, as  well as Canada, the European Communities, and 
the United States. 
 2. We consider it necessary that a ruling is made by  us on the request of the participants without 
delay.  Accordingly, we give a ruling with concise reasons.  These reasons may be further elaborated 
in the Appellate Body report. 
 
                                                     
 
1The participants expressed a preference for simu ltaneous, closed-circuit television broadcast to 
another room.  As alternatives, they mentioned delayed television broadcast and having a separate session for 
the third participants who elect not to participate in the open hearing.  WT/DS321/AB/R 
 Page 319 
 
 
3. The participants have different views on the scope of the term "proceedings" in Article 17.10 
of the DSU.  The European Communities argues th at the term "proceedings" in Article 17.10 should 
be interpreted narrowly as referring to  the Appellate Body's internal wo rk and does not include its oral 
hearing.2  The United States refers to the Recomme ndations by the Preparatory Committee for the 
WTO.  The United States contends that the Pr eparatory Committee viewed Article 17.10 as focused 
on the deliberations of the Appellate Body.3  Canada concedes that the term "proceedings" covers the 
oral hearing.  A similar view has been put forward by Brazil, China, India, and Mexico.  We consider 
the term "proceedings" to mean the entire proces s by which an appeal is prosecuted, from the 
initiation of an appeal to the circulation of the Appe llate Body report, including the oral hearing.  This 
is also how the Appellate Body understood the term in Canada – Aircraft .4  Having agreed with this 
broad interpretation of the term "p roceedings", we now consider the precise meaning and scope of the 
confidentiality requirement in Article 17.10.  4. The third participants that object to the re quest to allow public observation argue that the 
confidentiality requirement in Article 17.10 is abso lute and permits of no de rogation.  We disagree 
with this interpretation because Article 17.10 must be  read in context, particularly in relation to 
Article 18.2 of the DSU.  The second sentence of Article 18.2 expressly provides that "[n]othing in this Understanding shall preclude a party to a dis pute from disclosing statements of its own positions 
to the public".  Thus, under Article 18.2, the parti es may decide to forego confidentiality protection in 
respect of their statements of position.  With th e exception of India, the participants and third 
participants agreed that the term "statements of  its own positions" in Article 18.2 extends beyond the 
written submissions referred to in the first sentence of Article 18.2, and includes oral statements and 
responses to questions posed by the Appellate Body  at the oral hearing.  The third sentence of 
Article 18.2 states that "Members shall treat as c onfidential information submitted by another Member 
to the panel or the Appellate Body which that  Member has designated as confidential."  This 
provision would be redundant if Article 17.10 were in terpreted to require abso lute confidentiality in 
respect of all elements of appellate proceedings.  There would be no need to require, pursuant to 
Article 18.2, that a Member designate certain in formation as confidential.  The last sentence of 
Article 18.2 ensures that even such designation by  a Member does not put an end to the right of 
another Member to make disclosure to the pub lic.  Upon request, a Member must provide a non-
confidential summary of the information contained in its written submissions that it designated as 
confidential, which can then be disclosed to th e public.  Thus, Article 18.2 provides contextual 
support for the view that the confidentiality rule in Article 17.10 is not absolute.  Otherwise, no 
disclosure of written submissions or other statem ents would be permitted during any stage of the 
proceedings.  5. In practice, the confidentiality requirement in  Article 17.10 has its limits.  Notices of Appeal 
and Appellate Body reports are discl osed to the public.  Appellate Bo dy reports contain summaries of 
the participants' and third particip ants' written and oral submissions and frequently quote directly from 
them.  Public disclosure of Appellate Body reports is an inherent and necessary feature of our rules-based system of adjudication.  Consequently, u nder the DSU, confidentiality is relative and time-
bound.  
                                                     
 
2European Communities' request for an open hearing, para. 9.  Norway also argued for a narrower 
understanding of the term "proceedings". 
3United States' comments on the third participants' submissions regarding open hearings, paras. 5 and 6 
(referring to Establishment of the Appellate Body:  Recommendations by the Preparatory Committee for the 
WTO approved by the Dispute Settlement Body on 10 February 1995 (WT/DSB/1), para. 9). 
4Appellate Body Report, Canada – Aircraft , para. 143.  However, we note that that case did not involve 
a request to lift confidentiality;  rather, that dispute co ncerned a request for additional confidentiality protection 
for business confidential information. WT/DS321/AB/R 
Page 320  
 
6. In our view, the confidentiality requiremen t in Article 17.10 is more properly understood as 
operating in a relational manner.
5  There are different sets of relationships that are implicated in 
appellate proceedings.  Among them are the following relationships.  First, a relationship between the 
participants and the Appellate Body.  Secondly, a relationship between the third participants and the 
Appellate Body.  The requirement that the proceedi ngs of the Appellate Body are confidential affords 
protection to these separate relationships and is intend ed to safeguard the inter ests of the participants 
and third participants and the adj udicative function of the Appellate Body, so as to foster the system 
of dispute settlement under conditions of fairness, im partiality, independence and integrity.  In this 
case, the participants have jointly requested author ization to forego confiden tiality protection for their 
communications with the Appellate Body at the oral hearing.  The request of the participants does not 
extend to any communications, nor touches upon the re lationship, between the third participants and 
the Appellate Body.  The right to confidentiality of third participants vis-à-vis the Appellate Body is 
not implicated by the joint request.  The question is  thus whether the request of the participants to 
forego confidentiality protection sa tisfies the requirements of fairness and integrity that are the 
essential attributes of the appellate process and defi ne the relationship between the Appellate Body 
and the participants.  If the request meets these st andards, then the Appellate Body would incline 
towards authorizing such a joint request.  7. We note that the DSU does not specifically provide  for an oral hearing at the appellate stage.  
The oral hearing was instituted by the Appellate Body in its Working Procedures , which were drawn 
up pursuant to Article 17.9 of the DSU.  The conduct and organization of the oral hearing falls within 
the authority of the Appellate Body ( compétence de la compétence ) pursuant to Rule 27 of the 
Working Procedures .  Thus, the Appellate Body has the power to exercise control over the conduct of 
the oral hearing, including authorizing the lifting  of confidentiality at the joint request of the 
participants as long as this does not adversely affect the rights and interests of the third participants or 
the integrity of the appellate process.  As we observed earlier, Article 17.10 also applies to the 
relationship between third participants and the Appe llate Body.  Nevertheless, in our view, the third 
participants cannot invoke Article 17.10, as it applies to their relationship with the Appellate Body, so 
as to bar the lifting of confidentiality protection in the relationship between th e participants and the 
Appellate Body.  Likewise, authorizing the partic ipants' request to forego confidentiality, does not 
affect the rights of third participants to preserve the confidentiality of their communications with the 
Appellate Body. 
 
8. Some of the third participants argued that  the Appellate Body is itself constrained by 
Article 17.10 in its power to authorize the lifting of  confidentiality.  We agree that the powers of the 
Appellate Body are themselves circumscribed in that  certain aspects of confidentiality are incapable 
of derogation—even by the Appellate Body—whe re derogation may undermine the exercise and 
integrity of the Appellate Body's adjudicative functi on.  This includes the situation contemplated in 
the second sentence of Article 17.10, which provides that  "[t]he reports of the Appellate Body shall be 
drafted without the presence of the parties to the di spute and in the light of the information provided 
and the statements made."  As noted by the partic ipants, the confidentiality of the deliberations is 
necessary to protect the integrity, impartiality, and independence of the appellate process.  In our 
view, such concerns do not arise in a situation wher e, following a joint request of the participants, the 
Appellate Body authorizes the lifting of the confidentia lity of the participants' statements at the oral 
hearing.  9. The Appellate Body has fostered the active pa rticipation of third parties in the appellate 
process in drawing up the Working Procedures  and in appeal practice.  Ar ticle 17.4 provides that third 
participants "may make written submissions to, a nd be given an opportunity to be heard by, the 
Appellate Body."  In its Working Procedures , the Appellate Body has given full effect to this right by 
providing for participation of third participants during the entirety of the oral hearing, while third 
                                                     
 
5This relational view of rights and obligations of confidentiality is consistent with the approach 
followed in domestic jurisdictions with respect to similar issues, such as privilege.  WT/DS321/AB/R 
 Page 321 
 
 
parties meet with panels only in a separate session at the first substantive meeting.  Third participants, 
however, are not the main parties to a dispute.  Rather, they have a systemic interest in the 
interpretation of the provisions of th e covered agreements that may be at issue in an appeal.  Although 
their views on the questions of legal interpretation that come before the Appellate Body are always 
valuable and thoroughly considered, these issues of le gal interpretation are not inherently confidential.  
Nor is it a matter for the third participants to de termine how the protection of confidentiality in the 
relationship between the participants and the Appellate  Body is best dealt with.  In order to sustain 
their objections to public observation of the oral hear ing, third participants would have to identify a 
specific interest in their relationship with the Appella te Body that would be adversely affected if we 
were to authorize the participants' request—in this case, we can discern no such interests. 
 
10. The request for public observation of the oral  hearing has been made jointly by the three 
participants, Canada, the European Communities, and the United States.  As we explained earlier, the 
Appellate Body has the power to authorize a joint request by the participants to lift confidentiality, 
provided that this does not affect the confidentiality of the relationship between the third participants 
and the Appellate Body, or impair the integrity of  the appellate process.  The participants have 
suggested alternative modalities that allow for public observation of the oral hearing, while 
safeguarding the confidentiality protection enjoyed by the third participants.  The modalities include 
simultaneous or delayed closed-cir cuit television broadcasting in a r oom separate from the room used 
for the oral hearing.  Finally, we do not see the public observation of the oral hearing, using the means described above, as having an adverse impact on the integrity of the adjudicative functions performed 
by the Appellate Body. 
 11. For these reasons, the Division authorizes the public observation of the oral hearing in these proceedings on the terms set out below.  Accordingly, pursuant to Rule 16(1) of the Working 
Procedures , we adopt the following additional proced ures for the purposes of these appeals: 
 
(a) The oral hearing will be open to public ob servation by means of simultaneous closed-
circuit television.  The closed-circuit tele vision signal will be shown in a separate 
room to which duly-registered delegates of WTO Members and members of the general public will have access.   
(b) Oral statements and responses to questions by  third participants wishing to maintain 
the confidentiality of their submissions w ill not be subject to public observation.   
(c) Any third participant that has not alread y done so may request authorization to 
disclose its oral statements and responses to  questions on the basis of paragraph (a), 
set out above.  Such requests must be recei ved by the Appellate Body Secretariat no 
later than 5:30 p.m. on 18 July 2008 . 
(d) An appropriate number of seats will be reserved for delegates of WTO Members in 
the room where the closed-circuit broadcast will be shown. 
(e) Notice of the oral hearing will be provid ed to the general public through the WTO 
website.  WTO delegates and members of the general public wishing to observe the oral hearing will be required to register in advance with the WTO Secretariat. 
(f) Should practical considerations not allow si multaneous broadcast of the oral hearing, 
deferred showing of the video recordin g will be used in the alternative. 
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