WT/DS321/R 
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  VII. FINDINGS 
A. PROCEDURAL ISSUES  
1. Opening of the Panel meetings with the parties and experts for public observation  
(a) Introduction 
7.1 On 13 June 2005, at the first organizational mee ting of the Panel, the parties jointly requested 
that the Panel's substantive meetings with parti es be open for public observation.  Through written 
questions, the Panel requested the parties to specif y the legal basis in the DSU for such a request.  
Parties replied on 20 June 2005.  On  30 June 2005, the Panel posed add itional questions to the parties 
on the logistical implications of a hearing that  was open to the public.  The parties replied on 
7 July 2005.  The Panel held a second organizational meeting with the parties to discuss this issue on 
8 July 2005.307 
(b) Summary of the main arguments of the parties308  
7.2 With reference to the Panel's question whether panels are permitted to open hearings to public 
observation under Articles 12 (including Appendix 3), 14.1 and 17.10 of the DSU, the European 
Communities  argues that a panel may adopt working procedures that foresee open hearings, as 
Article 12.1 of the DSU provides that panels may depart from the working procedures in Appendix 3 after consulting the parties to the dispute. 
7.3 The European Communities also argues that this conclusion is not affected by Article 14.1 of 
the DSU on confidentiality of panel deliberations .  The term "deliberations" does not cover the 
meetings with the parties, for which a different terminology is used in Appendix 3 of the DSU.  
7.4 The European Communities considers that in the present case where all the parties have 
agreed to open hearings, the Panel should accommodate the parties' request.  Article 18.2 of the DSU also supports the position that parties are entitled to "waive" the confidentiality of their positions. 
7.5 Regarding the legal implications of open h earings on covered persons under the Rules of 
Conduct, the European Communities considers that no legal issues arise under the Rules of Conduct.  
In the European Communities view, the Rules of Conduct are and remain fully binding on all covered 
persons in this dispute, even if the hearings are ope ned to the public.  The Panel's deliberations will in 
any event not be affected by the opening and remain  confidential, as required by Article 14.1 of the 
DSU. 
7.6 With respect to the systemic and political impact of opening hearings, the European 
Communities is of the view that there are no imp lications for WTO Members who are not parties to 
this dispute, or on the intergovernmental character of the WTO, nor would it impair the chances to reach a mutually agreed solution, as preferred by  the DSU (Article 3.7).  Also, there are no 
implications for third parties because the parties have jointly requested that the public be excluded 
from the third parties' session during the presentation by  a third party, unless that third party agreed to 
make its presentation open for observation by the public. 
                                                     
 
307 The parties agreed to hold joint panel meetings in this case and that against the United States 
(WT/DS320) and to harmonize the Panels' timetables. 
308 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  WT/DS321/R 
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  7.7 Regarding the procedures that may be adopted to protect confidential information in an open 
hearing, the  European Communities indicates that it does not  expect that confidential information will 
be submitted in this dispute.  The European Commun ities does not consider that there is any issue of 
confidentiality in relation to information s ubmitted by other Members or non-Members (under 
Article 13 of the DSU), unless the confidentiality requ irement of the last sentence of Article 13.1 of 
the DSU applies, in which case the corresponding por tion of any meeting where this information is 
discussed could be closed. 
7.8 With respect to the third-party session, the Eu ropean Communities considers that each third 
party should decide whether to open the part of th e third-party session dealing with that third-party's 
statement. 
7.9 Canada  argues that the DSU allows for open hearings of WTO panels.  Article 14.1 of the 
DSU states that panel "deliberations" shall be confid ential.  The reference to "deliberations" indicates 
that this paragraph applies to the internal deliberations of panels, not  to the panels' meetings with the 
parties.  Furthermore, paragraph 2 of the Working Procedures in Appendix 3 of the DSU, which refers 
to closed panel meetings, is subject to DSU Articl e 12.1, which specifically allows a panel to deviate 
from the Working Procedures in Appe ndix 3 after consulting parties to  the dispute.  In cases such as 
this one, where all parties to the dispute have agreed  to open hearings, Canada is of the view that the 
Panel should accommodate such a request.  This position is consistent with the right of all parties to 
waive confidentiality as expressed in Article 18.2 of  the DSU, which states that a party is not 
precluded from disclosing statements of its own positions to the public.  In the present case, it is clear 
that all parties have agreed beforehand to waiv e their right to confidentiality during the panel 
hearings.   
7.10 Canada argues that the relevant provision in the Rules of Conduct is paragraph VII.1, which 
provides: "[e]ach covered person shall at all times maintain the confidentiality of dispute settlement 
deliberations and proceedings together with any info rmation identified by a party as confidential.  No 
covered person shall at any time use any inform ation acquired during such deliberations and 
proceedings to gain personal adva ntage or advantage for others." 
7.11 This provision, in Canada's view , requires confidentiality on the part of members of a panel of 
deliberations and proceedings.  However, in accord ance with paragraph II:1 of the Rules of Conduct, 
which expressly states that these Rules do not modify  the rules and procedures under the DSU, this 
provision is subject to a decision of the Panel to ho ld public hearings pursuant to Article 12.1 of the 
DSU.  Therefore, Canada considers that the obligation of covered persons to maintain the 
confidentiality of a panel proceedings continues to a pply but is modified to the extent that the Panel 
has decided to hold public hearings.  
7.12 Canada considers that opening the panel mee tings to the public can only contribute to the 
legitimacy, and perception of legitimacy, of the di spute settlement process.  The desire of the 
disputing parties to hold open hearings in this  case does not have any broader systemic or political 
implications – it merely serves the interests of the disputing parties in this case consistent with the 
institutional framework of the WTO and with Article 12.1 of the DSU.   
7.13 Canada submits that Article 12.1 of the DSU re quires that panels' decisions on their working 
procedures be taken in view of c onsultation with parties.  This pr ovision does not require consultation 
with third parties.  However, Canada recognizes th at third parties may have requested third party 
status with the expectation of participating in cl osed proceedings.  Therefore, Canada suggests that 
after the Panel decides to hold public hearings it sh ould consult with third parties to (a) identify any 
concerns of third parties regarding their particip ation in the proceedings, and (b) explore possible 
steps to accommodate such concerns.  Such accommodation measures may include turning off 
cameras during the delivery of oral statements of thir d parties that do not wish to deliver such an oral WT/DS321/R 
Page 138 
 
 
  statement in a public hearing.  Canada does not see a need for the Panel to consult with the Chairs of 
the DSB, of the General Council or of the DSB Sp ecial Sessions, or with the Director General. 
7.14 Canada believe that  a provision should be added to the Working Procedures that would 
provide a mechanism to protect business-confidentia l information that may become the subject of 
discussion during the public hearings.  Canada recommends a procedure under which a party may 
request the Panel to suspend the public nature of  the hearing for as long as such business-confidential 
information was being discussed.    
7.15 As to the third parties, Canada submits that they will have to follow the provisions in the 
Working Procedures adopted by the Panel pursuant to DSU Article 12.  Thus it is open to the Panel to decide that the oral statements by third parties will take place in public meeting.  However, it is also 
within the Panel's discretion to leave it to the choi ce of individual third parties whether they wish to 
make their oral statements in a private or public session.  Canada prefers giving third parties such a 
choice.  Canada recommends the adoption of a pract ical procedural mechanism to suspend the public 
nature of the hearing as necessary. 
7.16 Finally, Canada considers that the treatme nt of written materials presented by other WTO 
Members or by non-Members falls outside the scope of issues raised by the possible public nature of 
the hearing.  None of the parties has proposed a modification to the Working Procedures that would 
expand the categories of participants in the heari ng.  Nevertheless, Canada recognizes that the written 
evidence provided by other WTO Members or non-Memb ers may have been provided in confidence.  
To the extent that such confidential information is discussed during the hearings, there will be need to 
add to the Working Procedures a provision that would permit the Panel to interrupt the public nature 
of the hearing before a discussion of such confid ential written materials takes place.  In Canada's 
view, such a procedure should be similar to that  outlined above in respect of business-confidential 
information. 
(c) Summary of the arguments of the third parties
309  
7.17 Australia  contends that when parties agree not to follow the Working Procedures in 
Appendix 3, or parts thereof, it would be difficult fo r the Panel to justify a decision that goes against 
the wishes of the parties.  In Australia's view, to do so would undermine a basic principle of dispute 
settlement whereby parties consult with each other and with the Panel and seek mutual agreement on 
the conduct of disputes, according to Article 12.1 of the DSU.310 
7.18 While not objecting to the opening of the Panel' s hearing for public observation, Australia is 
however concerned about the modalities of organizi ng the meetings, equity of access and logistic 
issues and believes that the opening of the Panel's meetings to the public should be subject to the 
provisions that allow for protection of confidential information.311 
7.19 Brazil questions the specific grounds and the DSU provisions on which the Panel based its 
decision to accept the parties' request to open the Pane l meetings for public observation.  According to 
Brazil, transparency constitutes an important elem ent in the debate carried out by Members in DSB 
meetings, which will largely benefit from any further clarification by the Panel as to the legal reasons 
which motivated its decision to open the meetings to the public.312  
                                                      
309 A more detailed account of the third parties' argumen ts can be found in Section V of the descriptive 
part of this Report. 
310 Replies by Australia to Panel questions concerning open hearings, question 1. 
311 Replies by Australia to Panel questions concerning open hearings, question 2. 
312 Oral statement of Brazil, para. 2.  WT/DS321/R 
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  7.20 Brazil argues that a decision on whether or not to open panels' proceedings to the public relies 
solely on the WTO membership, in particular th e DSU review process which is the appropriate locus  
to deal with issues regarding the dispute settlement mechanism.  According to Brazil, if panels were 
to decide on this issue, they would go beyond their mandate, playing a role that is exclusive to the 
WTO membership.313 
7.21 Brazil also contends that opening the meetings  to the public would represent a reinterpretation 
of Article 14 of the DSU, signalling that there are cases to which confidentiality is not applied, such 
as Panel and Appellate Body meetings.314 
7.22 China  prefers the Panel to meet the third parties in closed session.  It argues that based on 
Article 18.2 of the DSU, panels do not have th e right unilaterally to disclose the third-party 
submissions and oral presentations.315 
7.23 India  submits that the issue of external tran sparency is being di scussed in the ongoing 
negotiations in the Special Session of the DSB. Un til there is a consensus on the opening of panel 
meetings to public observation and the modalities ther efor, India believes that the Panel proceedings 
have to be in closed session316, and its deliberations have to remain confidential317 as provided in the 
DSU.318 
7.24 India contends that the possibility of a pa nel to decide to deviate from the Working 
Procedures in Appendix 3 has been provided with th e view of having panel procedures with sufficient 
flexibility so as to ensure high-quality panel reports.319  In India's view, although panels are given 
some discretion in establishing their own working procedures, they do not have the discretion to 
modify the substantive provisions of th e DSU, such as confidentiality requirements.320 
7.25 India argues that Article VII of the Rules of Conduct321 requires each "covered person" to 
maintain the confidentiality of di spute settlement deliberations and proceedings at all times.  India 
questions how the Panel is going to ensure th at these requirements are met after opening the 
proceedings to the public for observation.322  
7.26 India submits that the decision of the Panel to  open its proceedings to the public necessarily 
involves some issues on which consultation and decisions with WTO Members, and not just the parties and third parties, would have been necessary.   For example, India questions how the Panel, at 
its own level, addressed issues relating to the implicat ions on the functioning of the WTO Secretariat, 
budgetary implications and implications relating to the use of the official languages of the WTO, for 
which rules and practices have been established by other bodies of the WTO.  India also questions 
how the Panel could take a view on the additiona l costs arising out of the opening up of the 
proceedings to public without the Budget  Committee having considered the matter.
323 
                                                      
313 Replies by Brazil to Panel questions concerning open hearings, question 1. 
314 Replies by Brazil to Panel questions concerning open hearings, question 1. 
315 Replies  by China to Panel questions concerning open hearings, questions 1 and 2. 
316 Paragraph 2 of the working procedures in Appendix 3 of the DSU 
317 Paragraph 3 of the working procedures in Appendix 3 of the DSU 
318 Replies by India to Panel questions concerning open hearings, question 1. 
319 Article 12.2 of the DSU. 
320 Oral statement of India, para. 6. 
321 Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of 
Disputes, adopted by the DSB on  3 December 1996 (WT/DSB/RC/1). 
322 Oral statement of India, para. 7. 
323 Oral statement of India, para. 8. WT/DS321/R 
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  7.27 According to India, the WTO is a Member-dri ven organization and it is solely for the WTO 
Members to decide whether or not to change th e WTO rules and open up panel proceedings to the 
public; a Panel cannot take upon itself that function, even at the request of parties to the dispute.324  
7.28 India posits that the meeting of the Panel with the third parties should be in closed session as 
required under paragraph 2 of the Working Proce dures contained in Appendix 3 of the DSU. 325 
7.29 Mexico disagrees with the opening of the Panel mee tings to the public on the grounds that 
panel meetings constitute panel "de liberations" and as such should be confidential, as per Article 14.1 
of the DSU.  Mexico also argues that transparen cy is a sensitive issue that is currently under 
discussion in the negotiations to amend the DSU.  Me xico argues that the DSU rules require that the 
meetings be confidential and, therefore, the deci sion of the two parties should only prevail to the 
extent that it does not affect the right of other Members including third parties.326 
7.30 Mexico emphasizes that public hearings are a cr oss-cutting issue that should be addressed in 
general by the WTO, and should not be imposed by a panel at the request of two Members.  Mexico 
regrets that the decision will set a precedent that ma y affect the outcome of the negotiations and will 
in all likelihood end up complicating the preparation of working procedures of future panels.327  
Mexico suggests that the third-party session follow the established WTO practice of being held in 
closed session.328 
7.31 According to New Zealand , there are no legal constraints that would prevent the Panel from 
opening its hearings to the public. New Zealand quot es Article 12.1 of the DSU which allows panels 
to follow the working procedures in the DSU unless the panel decides otherwise after consulting the 
parties.  New Zealand argues that while Appendix 3 provides for closed session hearings, the working 
procedures can be amended with the consent of the Panel and the parties.  New Zealand further notes 
that the reference in Article 14.1 of the DSU to pa nel deliberations being confidential refers to the 
internal deliberations of the panel, not the hearings with the parties.  New Zealand submits that this is 
in line with the practice of other internationa l tribunals which have open hearings but whose 
deliberations are nonetheless confidential.  According to New Zealand, Article 18.2 of the DSU allows parties to waive confidentiality.  New Zealan d did not object to its third-party hearings being 
public.
329  
7.32 Norway  considers that Article 12.1 of the DSU gives the Panel the discretion to follow other 
working procedures than the ones provi ded in Appendix 3 after consulting the parties.  It sees no legal 
constraints in granting the parties request to open th e hearings to the public.  Norway also agrees to 
having the third party session of the hearing open to the public.330 
7.33 The Separate Customs Territory of Ta iwan, Penghu, Kinmen and Matsu  (Chinese 
Taipei) argues that, in accordance with the procedures and customary practices developed over more 
than half a century under GATT, which are reflect ed in Articles 14.1, 18.2 and Appendix 3 of the 
DSU, panel proceedings are to be kept confidentia l.  It argues that only Members by consensus can 
                                                      
324 Oral statement of India, para. 9. 
325 Replies by India to Panel questions concerning open hearings, question 2. 
326 Oral statement of Mexico, para. 2; Mexico's replies to Panel questions following the first substantive 
meeting of the Panel, paras. 9 and 3. 
327 Oral statement of Mexico, para. 3. 
328 Replies by Mexico to Panel questions concerning open hearings, question 2. 
329 Replies by New Zealand to Panel questions concerning open hearings, questions 1 and 2. 
330 Replies by Norway to Panel questions concerning open hearings, questions 1 and 2.  WT/DS321/R 
 Page 141 
 
 
  change the rules of confidentiality.  According to Chinese Taipei, a panel, even with the consent of 
the parties does not have the legal authority  to open the proceedings to the public.331 
7.34 Chinese Taipei refers to Article VII of the Ru les of Conduct which requires that each covered 
person shall at all times maintain the confidentia lity of the dispute settlement deliberations and 
proceedings.  According to it, the only exception to this confidentiality obliga tion is Article 18.2 of 
the DSU.  Chinese Taipei is therefore of the opinion that this exception does not extend to the 
possibility of allowing parties to decide whet her to open panel meetings to the public.332 
7.35 According to Chinese Taipei, "panel deliber ations" implies more than one form of 
deliberation, thus including not only internal c onsideration among panelists, but also the entire 
process of the panel's consideration of the dispute.333 
7.36 Chinese Taipei argues that the flexibility aris ing from Article 12.1 of the DSU to change 
working procedures in Appendix 3 cannot be extended  to cover provisions in the working procedures 
that directly elaborate on the obligations of the DS U.  It further argues that if the drafters had 
contemplated that the confidentiality requirement could be changed, they would have said so, just like in Article 18.2 of the DSU.  In the absence of such language, only an amendment to the DSU by the 
Members through negotiations can change the requirement of confidential deliberations.
334 
7.37 Chinese Taipei is of the opinion that the th ird-party sessions should be held in closed 
session.335 
(d) Decision of the Panel 
7.38 On 1 August 2005, the Panel decided to accept th e parties' joint request to open the Panel 
hearings for public observation. The Panel also deci ded that the meetings at which the parties are 
invited to appear, as referred to in paragraph 2 of Appendix 3 to the DSU, would be open for 
observation by the public through a closed-circuit br oadcast, keeping in mind the Panel's obligation to 
ensure that its Working Procedures are objective, im partial and non-discriminatory, and after careful 
consideration of the existing provisions of the DSU a nd its Appendix 3. In addition, since not all third 
parties had agreed that their session with the Pa nel be open for observation by the public, the Panel 
decided that that session would remain closed.  As  provided in paragraph 3 of the Panel's Working 
Procedures336, the parties retain the right to request at any time, including during panel meetings at 
which they are invited to appear, that their specifi c statements not be broadcast so as to remain 
confidential.  The Panel also reser ved its right to decide on its ow n to suspend broadcasting at any 
time, including during such meetings.337 The Panel sent its revised Working Procedures and timetable 
to the parties and third parties on 1 August 2005. 
7.39 The Chairman of the Panel also sent letters to the Chairman of the DSB338 and the Director-
General of the WTO339, informing them of the Panel decisi on on this matter and requesting the 
                                                      
331 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 1 and 2. 
332 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, para. 4 and 5. 
333 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, para. 3. 
334 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 6 and 7. 
335 Replies by Chinese Taipei to Panel questions concerning open hearings, question 2, para. 12. 
336 The Panel's working procedures are contained in Annex A-2 to this report. 
337 The letter of the Panel to the Parties of 1 August 2005 is reproduced in  Annex  A-1 to this Report. 
338 See WT/DS321/8, 2 August 2005. 
339 Letter of the Chairman of the Panel to the Dir ector-General of the WTO of 2 August 2005. The 
letter reads as follows: 
"On behalf of the Panels in the two cases referred to above, I would like to request your assistance concerning the implementation of a procedural decision taken by the Panels. WT/DS321/R 
Page 142 
 
 
  assistance of the WTO Secretariat in making appropriate logistical arrangements for the open 
hearings. 
7.40 After the Panel decided to consult scientific experts340, the opinion of the parties was sought 
on whether they wished that any m eeting with the parties and the scientific experts also be open for 
public observation.  The parties replied affirmatively.  
7.41 Since this was the first time in GATT/WTO hist ory that a panel has held hearings open for 
public observation, the Panel deems it appropriate to el aborate further on the reasons why it agreed to 
open its substantive meetings for public observation.   
7.42 The Panel first wishes to recall that it acted at the joint request of the parties.  Some third 
parties, however, objected to the holding of a hear ing that would be observable by the public.  As a 
result, the hearing with third parties was not opened to public observation. 
7.43 The Panel considers that the DSU does not expr essly contemplate the possibility for meetings 
of panels to be open for public observation.  On the contrary, Paragraph 2 of Appendix 3 to the DSU 
provides that "the panel shall meet in closed ses sion" and that "The parties to the dispute, and 
interested parties, shall be present at the meeting onl y when invited by the panel to appear before it."  
The Panel understands this to mean that it shall always meet in camera , whether or not the parties 
and/or interested parties have been invited to appear  before it.  No reference is made in that provision 
to other Members or to the general public. 
7.44 However, Article 12.1 of the DSU provides that "[p]anels shall follow the Working 
Procedures in Appendix 3 unless the panel decides otherwise after consulting the parties to the 
dispute."  In other words, the Panel has the possibilit y to depart from any provision of Appendix 3, its 
only obligation being to consult the parties to the dispute first.     
                                                                                                                                                                     
Following a common request made by the parties on 13 June 2005, we have decided that the 
panel meetings to which the parties are invited to appear will be open for observation by the 
public through a closed-circuit TV broadcast.  We informed the parties of our decision on 1 
August 2005. The session with the third parties w ill remain closed as not all the third parties 
have agreed to have it open for observation by the public.  The third parties were advised of 
our decision on 1 August 2005.  Finally, the Ch airman of the DSB has also been advised of 
our decision, with a request that he informs the entire DSB membership of the possibility to 
observe the hearings.   
 
The Panels appreciate the assistance of the Secret ariat on these cases to date and would like to 
request continued Secretariat assi stance with respect to the logi stical arrangements needed to 
implement our decision.  In this regard, we would like to ensure transparency and non-
discriminatory access by all, in  particular by all WTO Members, to the closed-circuit TV 
broadcast.  For that purpose, we would requ est the Secretariat to guarantee that each WTO 
Member delegation has at least  two seats available in the ro om where the closed-circuit 
broadcast will be shown.  We would also ask th e Secretariat through its website to make all 
Members and the public aware that they are allo wed to attend the closed-circuit broadcast and 
to provide details on pre-registration and seating arrangements.  
 
We have scheduled the first substantive meeting of the Panels with the parties for 
12-15 September 2005 and understand that this meeting could take place in Room W with a 
closed-circuit TV broadcast of the meeting in the General Council Room.   
 
I would greatly appreciate your assistance in ensuring that the logi stical arrangements to 
which I have referred in this letter can be finalized by the Secretariat." 
 
340 See Section VII.A.2 below.  WT/DS321/R 
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  7.45 This discretion, however, applies only to th e provisions of the Working Procedures in 
Appendix 3, not to any other provision of the DSU.  The Panel thus is of the view that Article 12.1 
entitles it to proceed with any adap tation of the working procedures c ontained in Appendix 3, as long 
as such an adaptation is not expressly prohibited by any provision of the DSU.  Therefore, we  need to 
examine whether there is any DSU provision that  would explicitly prohibit the opening of panel 
meetings to public observation. 
7.46 The Panel notes in this respect the confiden tiality requirements contained in Articles 14.1, 
18.2 and Appendix 3, paragraph 3 to the DSU.  It al so recalls the obligations of its members pursuant 
to the Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of 
Disputes.341 
7.47 Regarding the requirement in Article 14.1 of the DSU that "[p]anel deliberations shall be 
confidential", the Panel first notes that  one of the ordinary meanings of the word "deliberations" is 
"careful consideration, weighing up with a view to decision". The term "deliberations" also applies to 
"[c]onsideration and discussion of  a question by a legislative assembly, a committee, etc.; debate".342  
However, the Panel is not of the view that a panel h earing is similar to a consideration by a legislative 
body or a committee.  Even though exchanges of points of view take place in both instances, the 
nature of the exchange of arguments by parties to a dispute before an adjudicating body remains 
different from that of an assembly or a committee.  This suggests that the term "deliberation" was not 
intended to cover the exchange of arguments between the parties, but rather the internal discussion of 
the Panel with a view to reach its conclusions.  We note that our interpretation of the term 
"deliberation" conforms to the use of that term in  the statutes of other international judicial bodies.343 
It is also confirmed by the context of Article 14.1.  Article 14 deals with confidentiality in the work of 
panels stricto sensu  (deliberations, drafting of the panel re port, opinions of panelists), whereas the 
provisions dealing with the conduct of the proceedings  with the parties are contained in Article 12. 
The Panel therefore concludes that Article 14.1 of the DSU does not apply to panel hearings and that 
opening the Panel's substantive m eetings with the parties to public observation does not breach that 
provision. 
7.48 Regarding the requirement contained in Article 18.2 of the DSU that "[w]ritten submissions 
to the panel ... shall be treated as confidential", we  note that, by opening its hearings to public 
observation, the Panel did not disclose to the public  the content of the parties' written submissions.  
By making statements to which the public could lis ten, the parties themselves exercised their right 
under Article 18.2 to "disclos[e] statements of [t heir] own positions to the public".  The Panel is 
mindful that, by asking questions or seeking clarifi cations during the hearings with respect to written 
submissions of the parties, it may have itself "discl osed" the content of such submissions.  However, 
the Panel notes that at all times the parties retained  the right to request that  specific statements of 
theirs not be broadcasted so as to remain confidentia l and that, in this case, the parties had made their 
                                                      
341 WT/DSB/RC/1, 11 December 1996. 
342 The New Shorter Oxford English Dictionary  (4th ed., 1993), p. 624. 
343 Article 46 of the Statute of International Court of Justice provides that "[t]he hearing in Court shall 
be public, unless the Court decides otherwise, or unless the parties demand that the public be not admitted".  Article 54.3 of the Statute provides that "[t]he deliberatio ns of the Court shall take place in private and remain 
secret ...". Article 26 of the Statute of the Internationa l Tribunal for the Law of the Sea provides that "[t]he 
hearing shall be public, unless the Tribunal decides otherwise, or unless the parties demand that the public be 
not admitted".   Article 42 of the Rules of the Tribunal  provides that" [t]he deliberations of the Tribunal shall 
take place in private and remain secret ...". Article 20 of  the Statute of the Interna tional Criminal Tribunal for 
Former Yugoslavia provides that "[t]he hearing in Court shall be public, unless the Trial Chamber decides to 
close the proceedings in accordance with  its rules of procedure and evidence".  Rule 78 of its Rules of Procedure 
and Evidence provides: "[a] ll proceedings before a Trial Chamber, other than deliberations of the Chamber, 
shall be held in public, unless otherwise provided."    Rule  29 provides that "[t]he deliberations of the Chambers 
shall take place in private and remain secret." WT/DS321/R 
Page 144 
 
 
  written submissions public.  The Panel notes also th at Article 18.2 provides that "Members shall treat 
as confidential information submitted by another Member to the Panel or the Appellate Body which 
that Member has designated as confidential ."344 We consider that this sentence clarifies the scope of 
the confidentiality requirement which applies to the Panel and to Members, a nd that panels have to 
keep confidential only the information that has b een designated as confidential or which has otherwise 
not been disclosed to the public.  Any other inte rpretation would imply a double standard, whereby 
panels would have to treat as confidential informa tion which a WTO Member does not have to treat as 
confidential.  The Panel also notes that, by reques ting that the Panel hold hearings open to public 
observation, the parties to this dispute have imp licitly accepted that their arguments be public, with 
the exception of those they w ould identify as confidential. 
7.49 Finally, the Panel notes that Article VII of th e Rules of Conduct for the Understanding on the 
Rules and Procedures Governing the Settlement of Disputes provides that "[e]ach covered person 
shall at all times maintain the confidentiality of dispute settlement deliberations and proceedings 
together with any information identified by a pa rty as confidential."  The Panel notes that such 
confidentiality obligation on the cove red persons during the panel proceedings is applicable to the 
extent not inconsistent with the DSU provisions.345  In this case, the parties waived their right to 
confidentiality and requested open hearings. As de monstrated above, the Panel accordingly adapted 
its working procedures by departing from Append ix 3 in a manner consistent with the DSU 
provisions.  Therefore, the Rules of Conduct should not be construed in a manner that would restrict the rights of Members under the DSU.  The Panel concludes that Article VII does not prevent the Panel from holding hearings open to observation by the public. 
7.50 The Panel is mindful that the issue of transpar ency of panel and Appellate Body proceedings 
is currently under review as part of the negotiati ons on improvements and clarifications of the DSU.  
However, the Panel recalls that the dispute settleme nt system of the WTO serves to preserve the rights 
and obligations of Members under the covered agreem ents, which include the DSU, and to clarify the 
existing provisions of those agreements in accordance with customary rules of interpretation of public 
international law.  The Panel considers that its role is not to address transparency in general terms, but 
to determine whether the DSU as it currently stands  permits that, under the circumstances of this 
particular case, the Panel hearing be open to p ublic observation. When called upon to decide on 
whether to open hearings to public observation, th e Panel concluded that this was the case.  However, 
this finding is limited to this particular case and is  without prejudice to any approach to the issue of 
transparency that the Members may negotiate.  
7.51 For the reasons set out in the previous paragra phs, the Panel considers that it is entitled, under 
the particular circumstances of this case and pursuant to Article 12.1 of the DSU, to open its hearings 
for public observation.  This is why the Panel d ecided to accept the parties' request to open its 
meetings with the parties for public observation.  The third-party session was, however, not open to 
public observation, due to the absence of con sensus among the third parties on this matter.
346        
7.52 The first substantive hearing with the parties was held on 12, 13 and 15 September 2005. The 
hearing with third parties took place on 14 Septembe r 2005.  The hearing with the scientific experts 
was held on 27-28 September 2006.  The second substa ntive meeting with the parties was held on 2 
and 3 October 2006. 
                                                      
344 Emphasis added. 
345 See Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of 
Disputes (WT/DSB/RC/1), Article II.1: 
 
"These Rules shall in no way modify the rights and obligations of Members under the DSU 
nor the rules and procedures therein." 
346 See WT/DS321/8.  WT/DS321/R 
 Page 145 
 
 
  2. Panel's decisions relating to the consultati on of individual scientific experts and 
international organizations 
(a) Decision to consult scientific experts 
7.53 During its first substantive meeting, the Panel requested the parties' views on whether there 
was a need to consult scientific experts should the Panel deem it necessary to examine the consistency 
of the EC implementing measure with the SPS Agreement  as part of its review of this case.347   
7.54 The European Communities  replied that it did not believe that it was necessary for this 
Panel to look into these scientific issues to make  findings and rulings purs uant to its terms of 
reference. However, the Panel did not have the e xpertise to decide on such issues itself, should the 
Panel decide to review the scientific issues at stak e. In such a scenario, the consultation of scientific 
and technical experts would be absolutely necessary. However, the European Communities 
considered that this Panel could not consult the experts that were used in the original EC – Hormones  
case. New experts would have to be chosen.348  
7.55 Canada argued that should the Panel deem it necess ary to consider whether the EC revised 
measure complies with the SPS Agreement , the complexity of the issues in this case would require 
consultation with scientific experts.  Were the Pane l to so decide, those experts should be consulted as 
to (a) whether the Opinions and/or studies relie d on by the European Communities constitute the 
necessary risk assessment identifying the risks to consumers that flow from the ingestion of meat from 
animals treated with oestradiol-17 β; (b) whether there is sufficient scientific evidence regarding the 
other five hormonal growth promotan ts at issue to enable the Europ ean Communities to conduct a risk 
assessment; and (c) whether current scientific knowle dge warrants the EC ongoing ban regarding the 
six hormonal growth promotants. 
7.56 Should the Panel decide to consult experts, in  Canada's view, those experts who advised the 
panel in the original EC – Hormones  case should be among the candidates. However, Canada might 
wish to propose several other recognized experts as candidates.349 
7.57 After having considered the parties' replies, the Panel  noted that, from the parties' replies to 
its questions, it appeared that no party disagreed that, should the Panel proceed with an assessment of 
the measure taken by the European  Communities to comply with the recommendations and rulings of 
the DSB in the EC – Hormones  case, advice from technical or scientific experts would be necessary.  
7.58 The Panel noted the views expressed by the Eu ropean Communities regarding the nature of 
this case and the order in which its claims should be reviewed by the Panel, but it was of the opinion 
that, at that stage, it was in its interest, as well as in the interest of the parties, to be fully informed of 
all relevant aspects of the dispute. The Panel thus  decided to initiate a process for consultation with 
experts in relation to the technical or scientific aspects of the compatibility of the EC implementing 
measure with the relevant provisions of the SPS Agreement , without prejudice to the positions held by 
any party in this respect and without prejudice to the conclusions that the Panel would ultimately 
reach on the claims raised by the European Communities.  The Panel informed the parties accordingly 
in a letter dated 20 October 2005.350   
7.59 The Panel does not deem it necessary to add to its  reasoning on this issue except to recall that, 
as specified by the Appellate Body in US – Shrimp : 
                                                      
347 Question 74 of the Panel after the first substantive meeting. 
348 EC's reply to Panel questions after the first substantive meeting, question 74, Annex B-1. 
349 Canada's replies to Panel questions after the first substantive meeting, Annex B-2. 
350 Annex A-3 to this Report. WT/DS321/R 
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  "... the DSU accords to a panel established by the DSB, and engaged in a dispute 
settlement proceeding, ample and extensive au thority to undertake and to control the 
process by which it informs itself ... of the relevant facts of the dispute ...  That authority, and the breadth thereof, is i ndispensably necessary to enable a panel to 
discharge its duty imposed by Article 11 of  the DSU to 'make an objective assessment 
of the matter before it, including an objective assessment of the facts of the case .' "
351   
7.60 In this particular case, as explained further in the subsequent sections of this report and in 
spite of the approach of the European Communities focusing on the breach of certain provisions of the 
DSU by the defending party, the Panel deemed it impor tant to consult experts in order to "make an 
objective assessment of the matter before it, includ ing an objective assessment of the facts of the 
case."  In addition, Article 11.2 of the SPS Agreement  "explicitly instructs"352 panels to seek expert 
advice in disputes under the SPS Agreement  involving scientific and technical issues: 
"In a dispute under this Agreement involving scientific or technical issues, a panel 
should seek advice from experts  chosen by the panel in consultation with the parties 
to the dispute."353 
7.61 The Panel is mindful that this case is not exactly  a dispute "under [the SPS] Agreement" since 
its terms of reference do not refer to the SPS Agreement .  We nonetheless consider that, since we may 
have to determine whether the European Communi ties has complied with its obligations under the 
SPS Agreement  if we need to determine whether Article  22.8 of the DSU has been breached, this 
dispute is, at least indirectly, "under [the SPS] Agreement". 
7.62 We therefore conclude that our decision to cons ult scientific experts is consistent with the 
requirements of the DSU and the SPS Agreement .  
(b) EC request for a single expert review group 
7.63 Once it decided to consult scientific experts, the Panel  sought comments from the parties on 
the proposed Working Procedures for Consultation w ith Scientific and/or Technical Experts, the 
technical or scientific aspects on which the Panel should consult experts and on whether the meeting 
with the experts and parties should be open for observation by the public. 
7.64 In a letter dated 3 November 2005, commenting on the draft working procedures for the 
consultation of experts, the European Communities  requested that a single expert review group be 
called upon to assist the Panel, arguing that it was important that the Panel receive consistent advice 
on the issues and that it would reduce the risk of the Panel having to review and decide between 
competing scientific views among the experts.  
7.65 Canada  replied that should a single expert grou p be appointed, experts would be required to 
arrive at common answers to the questions put to th em. This meant consensus of all experts would be 
required for each answer to questions.  Such a pr ocess would have serious repercussions for the 
consultation process.  
7.66 Canada also argued that past panels had fo llowed the practice envisaged in the Panel's 
proposed Working Procedures for Consultation with Experts, i.e. that the selected experts each 
provide their own advice in answer to questions from th e Panel and the parties.  In Canada's view, it is 
important that the answers of the experts can be  evaluated against the background of the areas of 
                                                      
351 Appellate Body Report on US – Shrimp , para. 106 (emphasis original). 
352 See Appellate Body Report on Japan – Agricultural Products II , paras. 127-128. 
353 Article 11.2 of the SPS Agreement , emphasis added.  WT/DS321/R 
 Page 147 
 
 
  expertise that each expert will bring to the process.  To enable such an evaluation, Canada requested 
the Panel not to follow the single expert group approach that the European Communities had 
proposed.354 
7.67 The European Communities  commented that its request was based on a desire to ensure the 
legitimacy of the Panel's findings by providing for a systematic, coherent and non-polarizing approach 
to complex scientific issues. Conversely, if expe rts acted as individuals, the Panel ran the risk of 
having to review and decide between competing scientific views amongst the Panel's experts as well 
as the experts advising the parties. This would normally  be very difficult, if not impossible, to do in a 
way that would ensure transparen cy, excellence and credibility in th is contested area of scientific 
research.  
7.68 The European Communities also drew the Panel's attention to Article 13.2 and Appendix 4 of 
the DSU, Article 11.2 of the SPS Agreement and Article 14.2 and Annex 2 of the TBT Agreement 
which, most probably for the reasons just menti oned above, all refer to the possibility to establish 
expert review groups . The European Communities did not see any reason to deviate from this normal 
procedure which the drafters of the WTO Agreements clearly preferred.355  
7.69 The Panel  reached its final decision on the working procedures for consultations with 
scientific and/or technical experts on 25 November 2005.356  Regarding the form the consultation of 
the experts should take, the Panel was not persuaded that the EC s uggestion to consult an expert 
review group was the preferable option.  Firstly,  the fields of competence proposed by the parties 
were quite varied, rendering it difficult to find indi vidual experts with competence in most or all of 
these fields to serve in an expert review group.  The fact that no expert would have a comprehensive 
knowledge of all the relevant subjects made it even more important for the Panel to seek advice from 
the experts on an individual basis on their respective fields of expertise.  Secondly, the Panel wished 
to hear any dissenting or minority views among the e xperts rather than receiving a consensus text 
from an expert review group.  The Panel did not consider that the risk  that experts may have diverging 
opinions would generate difficulties as serious as t hose alleged by the European Communities.  The 
Panel rather saw the risk that an expert revi ew group would only agree on a minimum common 
position, thus depriving the Panel of a full picture of the problems.  It was also worth noting that so 
far, all WTO panels had preferred to consult scientific  and/or technical experts on an individual basis.   
7.70 The Panel does not deem it necessary to add to the reasons mentioned above, except to clarify 
that, in its view, none of the provisions cited by the European Communities sets a preference for 
expert review groups. On the contrary, the consulta tion of expert review groups is mentioned only as 
one option, both in Article 13.2 of the DSU and in Article 11.2 of the SPS Agreement  and the terms of 
those provisions suggest that panels enjoy wide di scretion in deciding to seek or not the assistance of 
an expert review group rather than that of individual experts.  Indeed, Article 13.2 of the DSU 
provides that:  
"Panels may seek information from any rele vant 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."357 
                                                      
354 Canada's letter to the Panel of 8 November 2005. 
355 EC's letter to the Panel of 11 November 2005. 
356 Annex A-5 to this Report.  The Panel also decided that the meeting with the experts would be open 
for observation by the public in the same manner as the meeting with the parties. 
357 Emphasis added. WT/DS321/R 
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  7.71 Article 11.2, second sentence, of the SPS Agreement  provides that: 
"To this end, the panel may, when it deems it appropriate , establish an advisory 
technical experts group, or consult the rele vant international or ganizations, at the 
request of either party to the dispute or on its own initiative."358 
7.72 We read these provisions as leaving a wide marg in of discretion to the Panel.  We find 
confirmation of this reading in  the Appellate Body Report on EC – Hormones , where the Appellate 
Body recalled that: 
"Both Article 11.2 of the SPS Agreement  and Article 13 of the DSU enable panels to 
seek information and advice as they deem appropriate in a particular case ... 
We find that in disputes involving scientific or technical issues, neither Article 11.2 
of the SPS Agreement , nor Article 13 of the DSU prevents panels from consulting 
with individual experts.  Rather, both the SPS Agreement  and the DSU leave to the 
sound discretion of a panel the determina tion of whether the establishment of an 
expert review group is  necessary or appropriate."359 
7.73 We therefore conclude that our decision complies with the DSU, the SPS Agreement  and the 
practice of the Appellate Body. 
(c) Experts selection process 
7.74 One single expert selection process was carried out for the two cases WT/DS320 and 
WT/DS321.360  
7.75 After receiving input from the parties, the Panel,  in its letter of 20 January 2006, identified the 
need for expert advice in seven fields, namely:  
(a) risk analysis, in particular, the conduct of a risk assessment as it relates to food safety;  
(b) animal science, including good veterinary practices in relation to the administration 
of the six hormones361 to cattle through implants or other means;  
                                                      
358 Emphasis added. A contrario , Article 14.2 of the TBT Agreement  cited by the European 
Communities expressly limits the choice of the panel to a technical expert group. 
359 Appellate Body Report on EC – Hormones , para. 147. 
360 In this section, the term "Panel" refers to  the Panel in case WT/DS320 and the Panel in case 
WT/DS321.  The same individuals served as panelists in the two cases. 
361 The six hormones can be defined as follows:  
 
Oestradiol-17 β 
 
Oestradiol-17 β is the most potent mammalian oestrogenic sex hormone, responsible for 
female characteristics.  It is a member of a cla ss of compounds called steroids.  In females, it 
functions in the ovarian cycle and maintains uterine health; in males it inhibits the synthesis of 
testosterone.  It is produced primarily by the ovaries and the placenta.  In cattle, it is 
administered either alone or in combination with testosterone, progesterone and trenbolone by 
a subcutaneous implant to the base of the ear to improve body weight and feed conversion in 
cattle.  The ear is discarded at slaughter.  (Replies of Dr. Boisseau, Dr. Boobis and 
Dr. Guttenplan to Panel Question 1 to the experts.  Annex D, paras. 1; 7-8; 17) 
  WT/DS321/R 
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  (c) toxicology, including genotoxicity362, and carcinogenicity363 risks arising from the six 
hormones in meat; 
(d) inspection, sampling and testing methods, par ticularly in relation to residue analysis 
and characterization with respect to the six hormones;  
                                                                                                                                                                     
Progesterone 
 
Progesterone is the major mammalian progesta tional hormone, responsible for maintaining 
pregnancy.  It is a steroid and is secreted primarily by the corpus luteum in the ovary of adult 
females and in the placenta.  Progesterone is  used as a contraceptive and to correct 
abnormalities in the menstrual cycle.  In cattle, it is administered to steer, usually in 
combination with oestradiol-17 β or oestradiol benzoate by a subcutaneous implant to the base 
of the ear to improve body weight and feed conversion in cattle.  The ear is discarded at 
slaughter. (Replies of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the 
experts.  Annex D, paras. 2; 9-10; 18) 
 
Testosterone 
 Testosterone is a mammalian androgenic hormone, responsible for male characteristics.  It is a 
steroid and is produced primarily in the testes of adult males.  In cattle, testosterone is 
administered in combination with oestradiol -17 β or oestradiol benzoate by a subcutaneous 
implant to the base of the ear to improve body weight and feed conversion in cattle.  The ear is 
discarded at slaughter. (Replies of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel 
Question 1 to the experts.  Annex D, paras. 3; 11; 19) 
 
Trenbolone acetate 
 Trenbolone acetate is a synthetic steroid with anabolic (growth-stimulating) properties several 
fold above that of testosterone.  In cattle, it is administered alone or in combination with 
oestradiol-17 β by a subcutaneous implant to the base of the ear to improve body weight and 
feed conversion in cattle.  The ear is discar ded at slaughter. (Replies of Dr. Boisseau, 
Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts.  Annex D, paras. 5; 12; 20) 
 
Zeranol  
Zeranol is an oestrogenic substance produced by certain fungal, or mold, species.  It is a non-
steroidal anabolic (growth-stimulating) agent and has been used for the management of 
menopausal and menstrual disorders.  Zeranol is  administered to cattle either alone, or in 
combination with trenbolone acetate by a subcut aneous implant to the base of the ear to 
improve body weight and feed conversion in cattle.  The ear is discarded at slaughter (replies 
of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts.  Annex D, 
paras. 6; 13-14; 21).  Although zeranol occurs naturally, it is sometimes referred to as one of 
the synthetic hormones, together with  trenbolone and melengestrol acetate. 
 
Melengestrol acetate 
 
Melengestrol acetate (MGA) is an orally active sy nthetic progestogen abou t 30 times as active 
as progesterone.  It is fed to female cattle to improve body weight and feed conversion (replies 
of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts.  Annex D, 
paras. 4; 15-16; 22 ). 
 
362 Ability to cause damage to genetic material (DNA).  Such damage may be mutagenic and/or 
carcinogenic (Replies of Dr. Boobis  and Dr. Guttenplan to  Panel Question 2 to the experts.  Annex D, paras. 41 
and 58. See also Transcript of the Panel meeti ng with the experts, Annex G, paras. 85-90). 
363 Process of induction of malignant neoplasms (cancer) by chemical, physical or biological agents 
(replies of  Dr. Boobis and Dr. Guttenplan to Panel question 2 to the experts.  Annex D, paras. 44 and 60). WT/DS321/R 
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  (e) human endocrinology364, including endogenous365 production of hormones by 
humans, in particular prepubertal children;  
(f) dietary intake studies and epidemiology366 linked to meat consumption; 
(g) physiology, in particular related to the possible effects of the six hormones when 
consumed in meat on the imm une and nervous systems, a nd growth and reproduction. 
7.76 As stipulated in the Working Procedures for Consultations with  Scientific and/or Technical 
Experts adopted by the Panel on 25 Novemb er 2005 after consultation with the parties367, the Panel 
sought information not only from selected experts but  also from three relevant international entities, 
the Codex Alimentarius Commission (Codex)368, the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA)369, and the International Agency for Research on Cancer (IARC).370  While the 
questions to experts focused on the seven areas identified, the questions to the above-mentioned 
entities focused on institutional a nd procedural issues as well as definitions relevant to the case. 
7.77 Pursuant to the Working Procedures the Panel, on 29 November 2005, requested the 
Secretariats of the Codex Alimentarius Commission, JECFA and the IARC to recommend names of 
                                                      
364 Endocrinology:  "A subspecialty of internal medicine concerned with the metabolism, physiology, 
and disorders of the endocrine syst em." (Webster Online Dictionary) The endocrine system  is defined by the 
same dictionary as "The system of glands that release their secretions (hormones) directly into the circulatory 
system. In addition to the endocrine glands, include d are the chromaffin system and the neurosecretory 
systems." 
365 Endogenous:  "Produced inside an organism or cell. The opposite is external (exogenous) 
production." (Webster's Online Dictionary) 
 
366 "A branch of medical science that  deals with the incidence, distribu tion, and control of disease in a 
population; the sum of the factors controlling the pres ence or absence of a disease or pathogen" (Merriam-
Webster Online Dictionary (http://www. m-w.com/dictionary/epidemiology)). 
367 Annex A-4, letter from the Panel to parties on 25 November 2005, Annex A-5, Working Procedures 
for Consultations with Scientific and/or Technical Experts. 
368 The Codex Alimentarius Commission was established by FAO and WHO, under the Joint 
FAO/WHO Food Standards Programme, to develop international food standards, guidelines and other recommendations such as codes of practice; its First Session met in 1963. The main purposes of this Programme 
are protecting health of the consumers, ensuring fair trade practices in food trade, and promoting coordination of 
all food standards work undertaken by international governmental and non-governmental organizations.  The Codex Alimentarius Commission is one of the three international standard-setting organizations referenced in 
the SPS Agreement (reference: Codex Alimentarius website – www.codexalimentarius.net). Within the 
framework of the Codex Alimentarius Commission and its  procedures, the responsibility for providing advice 
on risk management lies with the Commission and its subsidiary bodies while the responsibility for risk 
assessment lies primarily with the joint F AO/WHO expert bodies and consultations. 
369 The Joint FAO/WHO Expert Committee on Food Additives (JECFA), which has been meeting since 
1956, is an international expert scientific committee that  is administered jointly by the Food and Agriculture 
Organization of the United Nations (FAO) and the World Health Organization (WHO). Its work includes the 
evaluation of food additives, contaminants, naturally occurring toxicants and residues of veterinary drugs in food.  JECFA serves as an independ ent scientific committee which perfor ms risk assessments and provides 
advice to FAO, WHO and the member co untries of both organizations. The requests for scientific advice are in 
general channelled through the Codex Alimentarius Commission (Codex).  Some countries use information 
from JECFA in the establishment of national food safety control programmes and Codex adopts standards based 
on evaluations by JECFA (reference: Fact Sheet – What is JECFA?   See  Annex 1 attached to Annex E-2). 
370 The International Agency for Research on Cancer (I ARC), established in 1965, is part of the World 
Heath Organization.  IARC's mission is to coordinate and conduct research on the causes of human cancer, the 
mechanisms of carcinogenesis, and to develop scientific stra tegies for cancer control. The Agency is involved in 
both epidemiological and laboratory research and disse minates scientific information through publications, 
meetings, courses, and fellowships (r eference: IARC website – www.iarc.fr).  WT/DS321/R 
 Page 151 
 
 
  candidate experts in the relevant fields.  The Panel contacted the 22 experts suggested by those 
international entities and requested that those intere sted and available to provide advice to the Panel 
submit their curriculum vitae, including publication list s, and disclose potential conflicts of interests.  
Eleven experts were interested and available.  The Panel provided all the information received from 
the experts to the parties, requesting them to i ndicate any compelling reasons why particular experts 
should not be chosen to provide advice to the Pane l in this dispute.  The parties provided their 
comments on the proposed experts on 16 January 2006.   Canada provided comments on one issue in 
the EC comments on 19 January 2006, i.e. the exclus ion of experts who had participated in JECFA's 
risk assessment work.  The Eu ropean Communities responded to Canada's comments on 30 January 
2006.  
7.78 Because the parties' positions with respect to the candidate experts differed significantly, on 
20 January 2006, the Panel requested the parties to suggest further names of candidate experts, in 
application of paragraph 6 of the Working Procedures.   
7.79 On 31 January 2006, the Secretary to the Panel sent letters to 49 additional experts suggested 
by the parties.  The Panel Secretary requested that  experts interested and available to provide advice 
to the Panel submit their curriculum vitae including  a list of publications and a disclosure of any 
potential conflicts of interests. 
7.80 Of the 71 experts suggested by the internati onal organizations and the parties to the two 
disputes, 40 experts indicated that they were ava ilable and 35 responded to the request for curriculum 
vitae and information regarding pot ential conflicts of interests. 
7.81 The information provided by the experts was sent  to the parties. The parties were once again 
given the opportunity to comment on each expe rt and to provide any compelling reasons why 
particular experts should not be chosen to provide advice to the Panel in these disputes. 
7.82 The parties provided their comments on the second set of experts names on 22 February 2006. 
The European Communities replied to comments fr om the United States and Canada on certain 
experts proposed by the European Communiti es in an additional letter to the Panel of 
27 February 2006.  The United States and Canada commented on the EC letter of 27 February on 
1 and 2 March respectively.  One party or another submitted objections with re gard 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 affiliated with the government of a party 
to this dispute; or was affiliated with JECFA;  or had received funding from the pharmaceutical 
industry; or had been involved in the regulatory approval of any of the six hormones. 
7.83 On 24 March 2006, the Panel informed the parties of the names of the experts that it had 
selected.  The Panel wishes to recall that, in the selection process, it amply consulted the parties and 
selected the experts in accordance w ith procedures previously determin ed by the Panel in consultation 
with the parties.371 The Panel excluded experts with close li nks with governmental authorities directly 
involved in policy-making regarding the six hormon es and experts with close links to pharmaceutical 
companies or involved in public advocacy ac tivities.  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 
specialists372 and because the Panel was of the opinion th at experts familiar with the JECFA reports 
would be well-placed to assist the Panel in understa nding the work of JECFA extensively referred to 
by the parties in their submissions, in partic ular by the European Communities.  Moreover,  the Panel, 
                                                      
371 Appellate Body Report on EC – Hormones , para. 148. 
372 See Annex E-2, JECFA's replies to Panel question 14, regarding the selection process of experts 
involved in JECFA's work. WT/DS321/R 
Page 152 
 
 
  who was fully aware of the fields of compet ence 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 al so had in mind the need to choose experts with 
expertise to cover all the fields id entified as at issue in the dispute. 
7.84 The experts selected by the Panel were: 
 Dr. Jacques Boisseau, Former Director, French  Agency for Veterinary Medicinal Products; 
  Dr. Alan R. Boobis, Director, Experimental Medicine & Toxicology Division of Medicine, 
Faculty of Medicine, Imperial College Londo n (also Professor of Biochemical Pharmacology 
at Imperial College London); 
 
 Dr. Hubert De Brabander, Professor and Head of  Faculty of Veterinary Medicine, Department 
of Veterinary Public Health & Food Safety, University of Ghent, Belgium; 
 
 Dr. Ronald L. Melnick, US National Ins titute of Environmental Health Sciences; 
 
 Dr. Wolfgang G. Sippell, Deputy Director, Depa rtment of Pediatrics, University of Kiel; 
Head of the Division of Pediatric Endocrinology & Diabetology, Children's Hospital, Christian-Albrechts-University of Kiel, Germany;   
 
 Dr. Kurt Straif, Scientist, Unit of Carcinoge nic Identification and Evaluation, International 
Agency for Research on Cancer, Lyon, France.  
 
7.85 On 28 March 2006, the European Communities requ ested that the Panel reconsider its choice 
of two of the experts, reiterating concerns  already discussed above by the Panel and  arguing that these 
experts had real or perceived c onflicts of interests that should disqualify them from assisting the 
Panel.  The Panel carefully considered the Eur opean Communities' request, including the information 
given regarding potential conflicts of interests.  Th e 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 ha d 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.  
The Panel concluded that the EC objections regarding those two experts were not justified.  Therefore, 
on 31 March 2006, the Panel gave notice to the pa rties that it had found no reason to change its 
decision concerning the selection of experts.
373 In addition, having considered the information 
available about the various candidates, the Panel found that  these two experts were the best choices 
among the very few individuals available with exper tise in the area of risk assessment and would be 
able to provide the Panel with insight on in ternational standards on the hormones at issue.374 
7.86 On 12 April 2006, the Panel gave notice to the pa rties that Dr. Melnick and Dr. Straif were no 
longer available to assist the Panel and that the Panel had chosen to replace these experts with: 
                                                      
373 Letter dated 31 March 2006 from the Panel to parties. 
374 The Panel wishes to highlight the challenges it en countered 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 parties objected to that sp ecialist.  For example, only six of the identified 
available experts were deemed to have extensive expertise in risk analysis.  All of these experts were objected to 
by at least one party.  WT/DS321/R 
 Page 153 
 
 
   Dr. Vincent Cogliano, Head of Programme, IARC Monographs on the Evaluation of 
Carcinogenic Risks to Humans, International Agency for Research on Cancer, Lyon, France; 
and 
 
 Dr. Joseph Guttenplan, Professor, Department of Basic Science, New York University Dental 
Center; Research Associate Professor, Depart ment of Environmental Medicine, New York 
University Medical Center. 
 7.87 In choosing experts to replace Dr. Melnick and Dr . Straif, the Panel was especially mindful of 
the need to replace these experts with others who coul d cover the same fields of expertise. Of the final 
six experts selected, three were amongst those orig inally suggested by the European Communities and 
three were suggested by the international organizations consulted by the Panel.   
7.88 Canada, in a letter dated 20 April 2006, requested  that the Panel amend its list of experts to 
include an expert with specific expertise with resp ect to good veterinary practices and their practical 
application in a North American context.  In a letter dated 10 May 2006, the European Communities 
objected to the request for an an imal science expert made by Canada, stating that all relevant 
questions could already be answered by the six experts. 
7.89 In light of the experts' replies as to which qu estions they would not be in a position to answer, 
and in light of the parties' comments, the Panel d ecided that it would first consider the written replies 
from the experts to the questions and then would determine if it was necessary to seek advice from 
additional experts. The Panel decided not to amend the list of selected expert unless there was a real 
need in the future and communicated its decision to the parties in a letter dated 10 May 2006.   
7.90 Because the Panel had requested Dr. De Braba nder and Dr. Boisseau to answer the questions 
on good veterinary practices to the extent that they  could, and because all questions were ultimately 
answered by at least one of the selected experts, the Panel did not find a need to consult additional 
experts.   
7.91 In accordance with the Working Procedures fo r Consultations with Scientific and/or 
Technical Experts adopted by the Panel in consultatio n with the parties, the experts were requested to 
act in their individual capacities and not as representatives of any entity. 
7.92 On 24 February 2006, the Panel sent to the parti es the draft questions to scientific experts and 
international organizations for comments.  The parties provided the Panel with their comments on 
15 March 2006.  After considering the parties' comments and after revising the draft questions as 
necessary, the Panel sent its 62 written questions to the individual scientific experts and its 26 written 
questions to the three international organizati ons (namely Codex, JECFA and IARC) on 13 April 
2006, together with the parties' su bmissions and accompanying exhibits. 
7.93 The Panel requested that the experts and the in ternational entities provide their written replies 
to the scientific and technical questions by 12 June 2006.
375   
7.94 The Panel, after receiving replies from expe rts and Codex, JECFA, and IARC, forwarded 
these replies to the parties on 14 June for their comments.  The parties provided their comments on 
these replies on 30 June 2006.376   Afterwards, parties were give n a further opportunity to comment on 
                                                      
375 A compilation of the written replies received from th e scientific experts can be found in Annex D. 
The written replies from the Codex Alimentarius Comm ission, JECFA and IARC can be found in Annex E-1, 
Annex E-2 and Annex E-3, respectively. 
376 See Annexes F-1, F-2 and F-4. WT/DS321/R 
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  each other's comments on experts' replies and re plies from international organizations. Parties 
provided these second rounds of comments on 12 July 2006.377   
7.95 The Panel met with the six experts and four  representatives from Codex, JECFA and IARC in 
the presence of the parties on 27-28 September 2006 in a meeting that was open for public 
observation through a closed-circuit television broadcast.  In this meeting, Dr. Vincent Cogliano, 
Head of the IARC Monographs Programme, served bot h as an individual scientific expert and as the 
representative of the IARC. The other representa tives were WHO JECFA Secretary Dr. Angelika 
Tritscher, FAO JECFA Secretary Dr. Annika Wennberg, and Codex Secretary Dr. Kazuaki 
Miyagishima.  The meeting provided an opportunity for the parties and the Panel to ask questions to the experts and for the experts to cl arify points that they had made in their written responses to the 
questions.
378  This meeting was followed by the Panel' s joint second substantive meeting with the 
parties on 2-3 October 2006. 
7.96 The Panel wishes to record its appreciation to  the experts and the representatives of the 
international entities for their contributions.  They  were provided with large volumes of scientific 
materials and a limited timeframe to reply to a long  set of questions.  They were also requested to 
reply to extensive questions from the parties and the Panel during the two-day meeting in Geneva. 
They provided detailed and comprehe nsive responses.  They provided the necessary scientific input to 
assist the Panel in understanding the issues raised by th e parties and resolve the trade dispute before it.  
The clarity of their explanations and their professiona lism were particularly appreciated by the Panel. 
3. Other procedural issues  
(a) Request by the European Communities that rele vant scientific evidence and data be provided 
by Canada 
7.97 In a letter dated 21 October 2005, the European Communities  requested that Canada 
provide the scientific studies on the basis of whic h it conducted its risk assessments and approved the 
six hormones at issue for animal growth promotion so that the Panel, the experts and the European 
Communities could be given an opp ortunity to consider them. 
7.98 Canada argued in a letter of 3 November 2005, that the Canadian measure at issue in these 
proceedings was Canada's European Union Surtax Order .  Because the European Communities had 
challenged the WTO-consistency of Canada's me asure, the issue of EC's compliance with the 
recommendations and rulings of the DSB in EC – Hormones  had arisen.  That was the reason for the 
Panel's inquiry into the EC's measure and conform ity of that measure with the recommendations and 
the rulings of the DSB in EC – Hormones .  The sanitary and phytosanitary  measure at issue was that 
of the European Communities.  It was the adequacy of the EC risk assessment that was relevant, not 
that of any other WTO Member.  Therefore, in Canada's view, the EC request was inappropriate.379 
7.99 In a letter to the Panel dated 8 November 2005, the European Communities  argued that the 
scientific basis of the EC measure at issue was being challenged with reference to assessments done 
by other bodies or institutions, including the de fending party's own regulatory bodies.  If the Panel 
and the experts were to assess objectively the relevan ce and sufficiency of the scientific information 
on which the European Communities relied in order to ban these substances, they would have to 
review also the underlying evidence on which JECF A and some WTO Members relied in order to 
conclude that the hormones at issue were safe.  Due process required that the Panel request the 
defending party to submit its underlying scientific studies. 
                                                      
377 See Annexes F-3 and F-5. 
378 A copy of the transcript of the meeting (hereaf ter the "Transcript") can be found in Annex G. 
379 Canada's letter of 3 November 2005.  WT/DS321/R 
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  7.100  In addition, the European Communities requested  that the Panel ask Codex to submit to the 
Panel the underlying scientific evidence and data that  served as the basis of the JECFA's assessments, 
which were invoked by the defending party in th ese proceedings.  In the view of the European 
Communities, the Panel was competent to request the information at issue both from the defending 
party and from Codex under Article 13 of the DSU.380  
7.101  Canada  rebutted in its letter of 10 November th at, although Canada referred extensively to 
the work of JECFA and the Codex Alimentarius Commi ssion,  the purpose was to show that there was 
indeed sufficient scientific evidence in respect of the five hormonal  growth promotants concerned to 
allow the EC to perform an adequate assessment of ri sk.  However, Canada did not cite the results of 
its own evaluation of the safety of the six hor monal growth promotants concerned in these 
proceedings, for the obvious reason that Canada's m easure was not at issue.   The issue here was 
whether the European Communities had performed a risk assessment in respect of oestradiol-17 β that  
complied with the SPS Agreement  and whether the European Communities had grounds to justify its 
position that there was insufficient scientific evidence in respect of the other five hormones to conduct 
an adequate risk assessment.381 
7.102  The European Communities  replied to the comments from Canada and the United States in 
a letter to the Panel dated 11 N ovember 2005.  The European Commun ities observed that a substantial 
amount of data on which JECFA based its findings  came from, and were available only with, the 
United States' and Canada's authorities since JECFA ha d to rely exclusively on data provided to it, 
inter alia , by its members and the relevant industry. T hus, in the case of the six hormones in question, 
JECFA, where it did not base itself on scientific ev idence publicly available, examined and relied on 
evidence that was available only with  the United States' and Canada's  regulatory authorities. Most of 
these studies were old and had never been publis hed in peer reviewed scientific journals.  
7.103  The European Communities added that, becau se the Panel had decided to examine the 
scientific basis of the EC compliance measure, this examination had to be carried out in the light of 
the assessments on which the responding party exp licitly based itself in order to question the 
European Communities' risk assessme nt and continue its unilateral suspension of concessions, i.e. its 
own risk assessments and those of Codex/JECFA.  
7.104  Canada  argued in a letter of 21 November 2005, th at the issues in these proceedings were 
simply (a) whether the European Communities could demonstrate that its ban on oestradiol-17 β was 
supported by a risk assessment as required by Article 5.1 of the SPS Agreement  and (b) whether its 
provisional ban on the other five hormones could be ju stified under Article 5.7 of that agreement.  In 
Canada's view, nowhere in the SPS Agreement , the DSU or indeed the WTO Agreement  as a whole 
was there a requirement that in assessing a Member's  conformity with its obligations under the WTO 
Agreement, a panel may ask other disputing parties to  justify their own measures that were not subject 
to dispute settlement.  Were it to do so, th e Panel would risk exceeding its jurisdiction. 
7.105  Canada also argued that more importantly, th e EC request was profoundly problematic from a 
systemic perspective.  The Panel need not ex amine Canada's assessment of the safety of these 
hormones to make findings in this regard.  Should  the Panel accept the EC's request, this would have 
wide-ranging systemic implications for future WTO disputes, especially under the SPS Agreement , as 
Members challenging the WTO consistency of an other Member's SPS measure could not do so 
without subjecting their own corresponding measure to  scrutiny in the same proceedings.  The EC's 
request would effectively impose an obligation on  Members that challenge another Member's SPS 
measures to conduct their own independent risk assess ments in respect of the challenged measures.  
This is nowhere set out in the SPS Agreement .  Canada considered that creating this obligation would 
                                                      
380 EC's letter to the Panel of 8 November 2005. 
381 Canada's letter of 10 November 2005. WT/DS321/R 
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  be contrary to Article 3.2 of the DSU.  It would also have obvious implications for all WTO 
Members, in particular for those that are devel oping or least developed countries and that do not 
necessarily have the kind of resources such risk assessment might require.382 
7.106  The Panel  considered the parties' arguments in its letter to the parties on the finalized working 
procedures for consultation with scientific and /or technical experts: 
"With respect to the EC's request that the Panel ask the US and Canada to provide the 
studies underlying the risk assessments of the US, Canada (and JECFA), the Panel is 
not in a position to fully assess the necessity fo r this information at this stage.  This 
said, the Panel notes that its task is not to  conduct a comprehensive assessment of the 
safety of hormones in meat.  Rather, shoul d the Panel consider it necessary for the 
resolution of the present dispute, it w ould assess the compatibility of the EC's 
measure with the provisions of the SPS Agreement .  Nevertheless, to the extent that 
this information becomes necess ary for the Panel to make its determination in this 
case, the Panel cannot exclude that it may request part or all of the information referred to by the EC.  More generally, the Panel expects the Parties' full 
collaboration in gathering the informati on necessary for an objective assessment of 
the matter before it.  The Panel also recalls that it is for each party to submit sufficient 
evidence in support of its assertions."
383   
7.107  In addition, the Panel wishes to recall its co mments above on its discretionary power to seek 
information or not pursuant to Article 13 of the DS U. The Panel also agrees with the parties that, 
while it has to make an objective assessment of th e matter before it, including an objective assessment 
of the facts, it is not supposed to make a de novo  review of factual information, including scientific 
evidence, regarding the six hormones at issue.  Thus , the Panel considered primarily in this context 
the measure taken by the European  Communities to comply with the recommendations and rulings of 
the DSB in the EC – Hormones  dispute.  Having regard to the a llocation of the burden of proof, the 
Panel deemed it appropriate to rely more partic ularly on the extensive amount of evidence submitted 
by the European Communities and Canada in their s ubmissions.  The Panel also took into account the 
opinions of the experts and the inputs from the in ternational entities it consulted under Article 13 of 
the DSU. To the extent that the parties and the experts discussed the EC implementing measure in the 
context of the work of JECFA and Codex, the Panel believes that it was suffici ently informed to make 
an objective assessment of the facts and did not need to ask Canada a nd Codex to provide the 
information requested by the European Communities.  
(b) Request by Canada to exclude materials not cited in the EC risk assessment as well as those 
published after the adoption of Directive 2003/74/EC  
7.108  In a letter of 15 March 2006 commenting on the Panel's draft questions to experts, Canada    
expressed the view that, asking experts to provide in formation on scientific and technical issues that 
were  neither considered in the assessment by the Scientific Committee on Veterinary Measures 
Relating to Public Health (SCVPH), nor by th e European Communities it self when it adopted the 
measure would generate informa tion that is unhelpful to the performance of the Panel's function.384  
7.109  The European Communities  stated that it had fundamental objections to the requests of the 
defending party.  They were contrary to the Appella te Body's interpretation of the requirements of a 
"risk assessment", as set out in EC – Hormones . They were in violation of the Panel's Working 
                                                      
382 Canada's letter of 21 November 2005. 
383 Panel letter to parties of 25 November 2005. 
384 Canada's letter to the Panel of 15 March 2006.  WT/DS321/R 
 Page 157 
 
 
  Procedures in this case, and they ran diametrica lly counter to the whole purpose of an expert 
consultation by the Panel.  
7.110  According to the European Comm unities, the issue of whether a measure could be considered 
to be based on scientific evidence that was not cite d or had not been taken into account in a risk 
assessment, or both, had already been settled by the Appellate Body in its report on  EC – Hormones , 
at paragraphs 188 through 191 . There the Appellate Body had dismissed the proposition by the 
complaining parties and the finding by the panel that  scientific evidence had to be cited in the risk 
assessment, as a "minimum procedural requirement".  The European Communities failed to understand 
why the defending party now re-opened an issue that had already been decided.  
7.111  The European Communities had submitted new mate rials as exhibits in its replies to the 
Panel's questions and as part of its second written submission. They we re, therefore, lawfully before 
the Panel and were directly covered by Para graph 13 of the Expert Working Procedures.  
7.112  According to the European Communities, the reque st of Canada had to be dismissed in view 
of the purpose of the experts' consultation. The principal objective of consulting experts was to 
provide the Panel with objective  information and advice on questions related to the scientific basis of 
Directive 2003/74/EC. In order to fulfil this task, the experts could not ignore the most recent and directly relevant scientific evidence that is publicly available.
385 
7.113  On 31 March 2006, the Panel addressed this issue in its letter to parties informing the parties 
that it would not reject a priori  any piece of evidence at that stage.  However, the Panel decided to ask 
experts to specify whether their reply would have b een different at the time of adoption of Directive 
2003/74/EC and why.  The Panel also requested the parties to identify, among the exhibits submitted, 
those studies to which they had had access before their publication date.  
"With respect to the issues raised in the letter of the United States on 14 March 2006, 
in Canada's comments of 15 March 2006, a nd in the European Communities' letter of 
23 March 2006, the Panel is reluctant to reject a priori any piece of evidence at this 
stage.  It will revert to this matter in its  findings, as appropriate.  In the meantime, and 
without prejudice to its final decision, th e Panel has decided to amend some of its 
questions to the experts and request them to specify whether their reply would have 
been different at the time of adoption of the measure at issue (September 2003) and, 
if not, why.   
In this respect, the Panel would be gratef ul if the parties could specify by Friday, 
7 April 2006, among the exhibits they s ubmitted, those studies to which they had 
access before their official publication dates a nd, if so, specify the date on which they 
had access to each of them."386 
7.114  Also, in its guideline letter sent on 30 March 2006 to the selected scientific and technical 
experts, the Panel specified that "wherever referen ce is made to scientific or technical facts, or 
comment is made on scientific evidence or literature , you are requested to provide references to the 
relevant studies and publications".387 
7.115  The Panel considers that its approach allowed it to have a better unders tanding of the situation 
at the time of the adoption of Directive 2003/74/EC.  However, since nothing has been submitted that 
became available subsequent to the adoption of th e Directive and that differed in any fundamental 
                                                      
385 EC's letter to the Panel of 23 March 2006. 
386 Panel letter to the parties of 31 March 2006. 
387 Panel guideline letter to selected experts of 30 March 2006. WT/DS321/R 
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  way from the evidence available at that time388, the Panel does not deem it necessary to address this 
issue any further.  
(c) A new version of Exhibit EC-107, submitted by the European Communities on 29 May 2006 
7.116  On 29 May 2006, the European Communities  submitted a new version of its Exhibit 
EC-107, entitled "The sensitivity of the child to sex steroids: possible impact of exogenous 
estrogens", a study published on 2 May 2006.  The European Communities stated that it would leave 
it to the Panel to decide whether to  forward this version to experts.389 
7.117  The Panel  decided on 23 June 2006 not to forward this version of Exhibit EC-107 to the 
scientific experts for the following reasons: 
"With regard to the EC letter of 29 May and its attachment, the Panel takes note of 
the fact that the study submitted as Exhibit EC-107 has now been 
published.  However, the Panel notes that  the version of the study submitted as 
Exhibit EC-107 and the version attached to the EC letter of 29 May are somewhat different and that the difference are apparen tly not merely editorial.  In this respect, 
the Panel recalls that the parties had been given until 21 December 2005 to submit 
factual evidence to the experts.  Therefor e, the Panel has decided not to send the 
published version of the study containe d in Exhibit EC-107 to the experts."
390 
7.118  We confirm the position we took in this letter.  We note that previous panels dealing with SPS 
measures have, in the context of proceedings under Article 21.5 of the DSU, considered measures  
adopted after the establishment of the panel.391  However, as far as evidence  is concerned, panels have 
generally refused to accept evidence submitted after a cer tain date, generally after the first substantive 
meeting, except for rebuttal purposes or upon a showi ng of good cause.  In this particular case, the 
parties had been given until 21 December 2005, i.e. several weeks after their second written submissions, to provide factual evidence that they de emed relevant.  The Panel considered also that 
submitting a modified study to experts at a relatively late stage of the expert consultation proceedings 
could generate confusion.   
(d) Procedure for allowing the parties to comment on each other's replies to questions after the 
second Panel meeting 
7.119  On 20 October 2006, the Panel, in line with the decision taken at the request of the  United 
States in dispute WT/DS320, confirmed to parties that  they would have an opportunity to comment on 
each other's replies to questions after the second Pane l meeting.  The deadline for such comments was 
31 October 2006.
392 
(e) Request by the European Communities to be a llowed to correct factual errors allegedly 
contained in the other party's comments on its replies to questions following the second Panel 
meeting 
7.120  On 13 November 2006, the European Communities  informed the Panel that it had studied 
the comments submitted by the United States and Canada on 31 October 2006  and had identified a 
                                                      
388 This was confirmed by the experts when they were requested to specify in their replies to questions 
of the Panel whether their views would have been different at the time of the adoption of Directive 2003/74/EC. 
389 EC's letter to the Panel of 29 May 2006. 
390 Panel letter to the parties of 23 June 2006. 
391 See Australia – Salmon (Article 21.5 – Canada) , Japan – Apples  (Article 21.5 – US).  
392 Panel letter to the parties of 23 October 2006.  WT/DS321/R 
 Page 159 
 
 
  number of inaccuracies and factual errors in their comments likely to affect the adjudication of the 
cases.  
7.121  The European Communities request ed that the Panel allow the parties to submit comments on 
the factual allegations contained in the comm ents on the responses.  These comments would be 
restricted to factual matters and would not seek to further discuss any of the legal issues.  This would 
enable the Panel to make an objective assessment of the facts and ensure a high quality panel 
report.393 
7.122  Canada  argued in a letter of 14 November 2006, that  it had every confidence that the Panel 
would be able to make an objective assessment of the matter before it on the basis of the extensive 
submissions, replies to questions and comments on re plies to questions that the parties had already 
made in this case.   
7.123  Canada was concerned that, should the EC request  prevail, it would lead to an endless loop of 
additional comments.  In Canada's view, the EC  knew what the procedure and the sequence of 
comments would be.  It was a standard sequence in panel proceedings.  The EC request was simply an 
attempt at this point to have the last word, rather th an to correct any alleged inaccuracies in the record.  
Therefore, Canada requested the Panel to reject the EC's request and stated that, should the Panel 
decide to grant such additional chance to the EC for further comments, Canada would be entitled to 
comment on the EC's comments. 
7.124  The Panel decided, on 20 November 2006, to reject the EC request: 
"Having carefully reviewed the arguments of  the parties, the Panel does not consider 
it appropriate to offer them another opportuni ty to comment on alleged factual errors 
made by the other party.  Procedurally, the Panel does not see any difference between 
comments on factual elements and comments on legal arguments; both can easily lead to endless discussions.  The Panel is c oncerned that giving such an opportunity 
to parties could open the door to further de lays in these proceedings since it would be 
difficult, once the Panel has allowed comments not foreseen in its timetable, to reject 
requests for additional comments on the other party's comments.  At this juncture, the 
Panel believes that it has been sufficiently in formed by the parties and the experts to 
be able to make an objective assessment of the case and deems it preferable to continue with the preparation of its re port without further exchanges of comments 
between the parties.  The Panel notes in this respect that the DSU provides 
opportunities for the parties to submit written comments, at a later stage, on the descriptive (factual and arguments) sections of the Panel Report and to request the 
Panel to review precise aspects of its Interim Report."
394 
7.125  The Panel does not deem it necessary to  add anything to the reasoning above. 
(f) Request by the European Communities for tape recordings of the transcript of the Panel 
meeting with scientific experts 
7.126  On 31 January 2007, the Panel  sent to the parties a draft written transcript of the hearing with 
the experts, for their review and comments. 
7.127  On 14 February 2007, the European Communities , in the cover letter accompanying its 
comments on the transcript, requested the Panel to provi de the parties with the  tape recordings of the 
                                                      
393 EC's letter to the Panel of 13 November 2006. 
394 Panel letter to the parties of 20 November 2006. WT/DS321/R 
Page 160 
 
 
  meeting with the experts for them to check the accuracy of the transcr iption of the experts' replies.  
The European Communities argued that the replies of  some of the experts were not properly or not 
fully reflected in the transcript, but did not identify  specific parts of the transcript where such errors 
allegedly occurred.395  
7.128  The Panel , in a letter dated 19 February 2007, requested the European Communities to 
identify in the draft transcript the places where th e European Communities believed the replies of the 
experts during the meeting had not been pr operly reflected.  The Panel added that, 
once the information had been provided, the Panel itself would further review the draft and make 
appropriate corrections if necessary. The Panel adde d that the parties had until 5 April 2007 to submit 
such information. 
7.129  The European Communities  responded to the Panel on  28 Fe bruary 2007, confirming that it 
was not in a position to identify in advance all the places where the transcript may not be entirely 
accurate, unless it was given copies of the tapes. Th e European Communities added that some of its 
doubts had already been pointed out by the United St ates and some more doubts existed as regards the 
statements by one expert and by the representa tives of the WHO and JECFA. The European 
Communities also stated that the tapes had b een provided to parties in the past in the EC – Hormones , 
the EC – Asbestos  and the second EC – Bananas  cases.396 
7.130  The Panel  replied that, to its knowledge, in circum stances similar to the present dispute, 
panels had never provided the tape recordings used in transcrip ts of meetings with scientific or 
technical experts to parties for review.  As the Pa nel indicated in its message on 19 February to all 
parties, parties were welcome to identify any pl aces in the draft transcript where they believed 
inaccuracies could exist and the Panel would fu rther review the draft and make appropriate 
corrections if necessary.397  
7.131  On 28 March, the European Communities  replied that tapes of recordings had been 
provided previously upon request.  In support of its allegation, it submitted a tr ansmission slip of 21 
April 1997 in the EC – Hormones  panel procedure. The European Communities added that it was 
entitled to expect that tapes be provided in this case as well. 
7.132  The European Communities also pointed out that the written transcript of the meeting of the 
Panel with the scientific experts had been sent with c onsiderable delay to the parties for verification.  
In view of the time which had elapsed, it was very difficult to verify the transcript with the required 
degree of certainty, in the absence of the recordings. 
7.133  The Panel sent to the parties an additional message on 18 April 2007, rejecting the EC 
request for tape recordings: 
"Since the latest message from the Panel to the parties on 26 March 2007, the Panel 
has received from the Eu ropean Communities an additional communication on 28 
March, indicating that tape recordings  had been provided to the European 
Communities in the original  EC – Hormones  panel proceedings.   
The Panel subsequently received a letter fro m the Unites States indicating that the EC 
failed to mention that the transmission slip  it submitted together with its 28 March 
letter is not related to the tapes of the expert meeting in the original EC – Hormones  
dispute because the date mentioned on that slip (7 January 1997) does not correspond 
                                                      
395 EC's letter to the Panel of 14 February 2007. 
396 EC's e-mail to the Panel of 28 February 2007. 
397 E-mail of the Panel to the parties of  26 March 2007.  WT/DS321/R 
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  to the date of the experts meeting (17-18 February 1997) in the original EC – 
Hormones  dispute between the United States and the European Communities 
(WT/DS26).  
The Panel found that the meeting date menti oned on the slip provided by the EC was 
the date of the first substantive m eeting of the panel in the original EC – Hormones  
dispute between the European Communities a nd Canada.    The meeting with experts 
in the two disputes was jointly held on 17-18 February 1997, while the meetings with 
parties were held separately.  After further verification, we can confirm that, to the best of our knowledge, the tape recordings  of the experts meeting on 17 and 18 
February in the two original EC – Hormones  panels were never provided to the 
parties.  
The Panel recalls that the European Commun ities' request is based on its desire to 
check whether the experts' replies at th e experts meeting have been accurately 
reflected in the transcript.   Consistent w ith the practice of other panels, the Panel has 
invited the parties and the experts to veri fy the accuracy of their own interventions 
during the meetings.  In addition, the Pane l invited the parties to identify any places 
in the draft transcript where they believe inaccuracies could exist and the Panel was 
ready to review those portions of the tran script and make appropriate corrections if 
necessary.  
By 5 April 2007, a deadline date set by th e Panel in its communication to the parties 
on 26 March 2006, none of the parties had identified any such inaccuracies. 
Therefore, on the basis of the above, the Panel does not deem it necessary to provide 
the tape recordings of the meeting with the experts to the parties."
398  
7.134  The European Communities  sent another message to the Panel on 11 May 2007, 
commenting on the Panel's decision: 
"The European Communities appreciates the e-mail of the Panel of 18 April replying 
to our additional communication on 28 March, indicating that the tape recordings that 
had been provided to the Europ ean Communities in the original  EC – Hormones  
panel proceedings were not from a hearing with scientific experts.    
In that case we did indeed receive (and still have in our archives) from the panel five 
tapes of 90 minutes each of the meeting held on 7 January 1997, which was indeed a 
meeting not with scientific experts.  The poi nt we were making is that since panels 
have provided the parties in the past tapes of a regular hearing, why is it not possible 
to provide the tapes of a hearing with scientific experts (where verification of what 
exactly was said is even more important)?   
More generally, panels send to parties th e factual part of the draft report for 
verification (which is essentially done on th e basis of the written submissions of the 
parties). The hearing with scientific experts is also part of the factual part of the report.  So, one can expect that the tapes from such a hearing with scientific experts 
can also be sent for verification.  This is all the more important in the case of a 
hearing with scientific experts, because it is impossible both for the scientific experts 
and the parties to take verbatim notes of a hearing that lasted two days and with the 
speed at which the oral exchanges take place in such hearing.  Indeed, the scientific 
                                                     
 
398 Panel letter to the parties of 18 April 2007. WT/DS321/R 
Page 162 
 
 
  experts presumably did not take verbatim notes of what they said during the hearing 
and so they are in the same difficult positi on as the parties to remember what exactly 
they have said several months ago. Fo r example, the European Communities has 
some doubts whether the following paragraphs of the draft report it has received 
reflect accurately what exactly has been said by the experts during the hearing on 
27-28 September 2006: paragraphs 353, 386, 388, 390, 421-422, 500, 690, 706, 710, 
719-720, 734, 779, 785, 891, 994, 1018, 1028. Furthermore, the European 
Communities considers that something may be wrong or missing between paragraphs 972 and 973 of the draft report. 
The European Communities resp ectfully requests the Panel to reconsider its position.  
If the Panel still feels unable to provide the European Communities with the tapes, it 
would ask the Panel to set out its reasons for refusing this request in the Report." 
7.135  On 5 June 2007, the Panel  informed the parties that the European Communities had not 
identified the relevant paragraphs in the draft transcr ipt that it wanted the Panel to review before the 
deadline of 5 April 2007, as specified by the Panel in  its earlier communication to the parties.   At 
such a late stage, the Panel had every reason to di sregard the request for review of the paragraphs 
identified by the European Commun ities in its letter of 11 May 2007.   Nevertheless, as a matter of 
prudence, the Panel checked the relevant paragraphs in the draft transcript against the original tape 
recordings and did not find any discrepancy beyond  minimal editorial adjustments.  Therefore, the 
Panel saw no reason to reverse its decision not to provide tape recordings of the meeting with 
scientific experts to the parties for further review.  
7.136  The Panel believes that the reasons for its deci sion not to provide tape recordings of the 
meeting with scientific experts were sufficiently d escribed in its communications .  It does not deem it 
necessary to elaborate on them any further. 
4. Scope of the Panel's mandate 
(a) The measure at issue and the claims of the European Communities  
7.137  The matter before this Panel is the alleged failu re of Canada to comply with the DSU and the 
GATT 1994 in response to the adoption and notification to the DSB of an alleged compliance 
measure by the European Communities in the EC – Hormones  case.
399 
7.138  The measure at issue is the continued applicati on by Canada, after the notification to the DSB 
of Directive 2003/74/EC by the European Comm unities, of its decision to apply, as from 
1 August 1999, import duties in excess of bound rat es by imposing a surtax on a number of products 
imported from certain member States of the European Communities400 without recourse to the 
procedures under the DSU.  This decision had been ta ken pursuant to an authorization granted by the 
DSB to Canada  to suspend concessions a nd other obligations on 26 July 1999.401  
7.139  In its request for establishment of a panel, th e European Communities lists Articles I and II of 
the GATT 1994 and Articles 23.1, 23.2(a) and (c); 3.7, 22.8 and 21.5 of the DSU as having been breached by Canada.  However, in its first wr itten submission and subsequently, the European 
                                                     
 
399 WT/DS48. 
400 European Union Surtax Order , SOR/99-317, adopted on 28 July 1 999, Canada Gazette, Part II, Vol. 
133, No. 17, 18 August 1999, at 2012-2016.  WT/DS321/6. 
401 WT/DSB/M/65, p. 19.  WT/DS321/R 
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  Communities elaborates on the scope of those claims. More particularly, it divides its claims between 
a set of main claims and one conditional  claim.402   
7.140  The European Communities also specifies how its main  claims of violation of the DSU 
should be addressed.  The European Communities ma kes a first series of main claims, alleging  a 
violation of Article 23 of the DSU and, more par ticularly, Article 23.2(a) read in conjunction with 
Articles 21.5 and 23.1 of the DSU.  The European Communities also makes a second series of main 
claims, alleging a violation of Article 23.1, read in  conjunction with Articles 22.8 and 3.7 of the DSU.  
In support of the second series of claims, the European Communities alleges that it enjoys a 
presumption of good faith compliance "which cannot be undermined by a unilateral and unsubstantiated determ ination by Canada."
403 
7.141  The European Communities adds in its first submission that Directive 2003/74/EC, which it 
claims implemented the recommendations  and rulings of the DSB in the EC – Hormones  case, is 
compatible with Article 5.1 and 5.7 of the SPS Agreement .  However, there is no reference to 
provisions of the SPS Agreement  in the EC request for establishment of a panel. 
7.142  The conditional  claim, that of a violation of Article 22.8 of the DSU per se,  is "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".
404 
7.143  This conditional  claim is, like the second series of ma in claims raised by the European 
Communities, based on the EC view that it has comp lied with the recommendations and rulings of the 
DSB in the EC – Hormones  case by adopting Directive 2003/74/EC and properly notifying it to the 
DSB. The difference is that, under the conditional claim, the European Co mmunities alleges actual 
compliance, and not that it should be presumed to have complied in good faith. 
7.144  The EC implementing measure imposes a defi nitive import prohibition on meat and meat 
products from animals treated for growth promotion purposes with oestradiol-17 β and a provisional 
ban on meat and meat products from animals treated for growth promotion purposes with testosterone, 
progesterone, trenbolone acetate, zeranol and melengestrol acetate.  The EC implementing measure is allegedly "based on a comprehensive risk assessment  and, thus, is fully compliant with the DSB 
recommendations and rulings.  In particular, [ according to the European Communities and] as 
stipulated by the Appellate Body, the results of th e risk assessment 'sufficien tly warrant' the definite 
import prohibition regarding one of the hormones (Article 5.1 of the SPS Agreement ), [footnote 
omitted] and provide the 'available pertinent in formation' on the basis of which the provisional 
prohibition regarding the five hormones has been enacted (Article 5.7 of the SPS Agreement )."
405     
(b) Are the indications provided by the European Communities on how it wants its claims to be 
addressed part of the mandate of the Panel? 
7.145  As a preliminary remark, the Panel notes that, when dealing with the scope of panel terms of 
reference, panels and the Appellate Body so fa r addressed situations where panel requests were 
alleged to be insufficiently precise.  In the pr esent case, the EC request fo r the establishment of a 
panel, while not as explicit as the EC first written s ubmission, explains in its section 2 ("The object of 
the dispute") some of the elements of the approach  that the European Communities wants the Panel to 
follow.  Yet, it does not outline its claims as was done in the EC first written submission.  For 
instance, the request for the establishment of a pane l lists Article 22.8 but it does not differentiate 
                                                      
402 EC's first written submission, para. 8. 
403 EC's first written submission, para. 70. 
404 EC's first written submission, para. 133. 
405 EC's first written submission, para. 17. WT/DS321/R 
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  between the main "systemic" claim relating to Ar ticle 22.8 (violation of Article 23.1, read in 
conjunction with Articles 22.8 and 3.7 of the DSU) and the conditional "direct" claim of violation of 
Article 22.8.  Likewise, in the request for establishment of a panel, each provision is identified separately, without any terms like "read together with" or "read in conjunction with." 
7.146  In Korea – Dairy , the Appellate Body defined the meaning of claim  and arguments  as 
follows: 
"By claim , we mean a claim that the respondent party has violated, or nullified or 
impaired the benefits arising from, an identif ied provision of a particular agreement.  
Such a claim of violation  must, as we have already noted, be distinguished from the 
arguments  adduced by a complaining party to demonstrate that the responding party's 
measure does indeed infringe upon the identified treaty provision."
406 
7.147  In the opinion of the Panel, the approach of  the European Communities as developed in its 
first written submission does not amount to "argumen ts" insofar as it does not "demonstrate that the 
responding party's measure does ind eed infringe upon the identified tr eaty provision". In fact, it does 
not purport to explain to what extent the EC claims  are justified, but simply circumscribes their scope. 
7.148  We further note that, in US – Carbon Steel , the Appellate Body stated that: 
"[I]n considering the sufficiency of a pane l request, submissions and statements made 
during the course of the panel proceedings, in  particular the first written submission 
of the complaining party, may be consulte d in order to confirm the meaning of the 
words used in the panel request and as part  of the assessment of whether the ability of 
the respondent to defend itself was prejudiced.  Moreover, compliance with the 
requirements of Article 6.2 must be dete rmined on the merits of each case, having 
considered the panel request as a whole, and in the light of attendant 
circumstances."407  
7.149  The Panel is mindful that this statement was made  in relation to a situation where the terms of 
reference were alleged not to cover specific claims.  On the contrary, in th e present case, the European 
Communities narrows the terms of reference of the Panel insofar as it requires a specific approach to 
the provisions allegedly breached. However, th is statement equally applies in the present 
circumstances to the extent that the EC first written submission may be  consulted in order to confirm 
the meaning of the words used in the request for establishment of a panel. 
7.150  In that context, it can be considered that th e approach to this case re quested by the European 
Communities and contained in its first written submi ssion is actually a clarification of the claims 
listed in its request for establishment of a panel a nd not arguments, and that it informs those claims.  
7.151  We therefore conclude that the EC approach ou tlined in its first written submission is part of 
the Panel's terms of reference. One consequence is  that since the claim of "direct" violation of 
Article 22.8 is made in the alternative , the Panel cannot and will not address it unless the European 
Communities fails to establish its main claims. The other consequence is that we should address the 
main claims as elaborated by  the European Communities in its first written submission and 
subsequently. 
                                                      
406 Appellate Body Report on Korea – Dairy , para. 139. 
407 Appellate Body Report on US – Carbon Steel , para. 127.  WT/DS321/R 
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  (c) Meaning of "read together with" and "in conjunction with" in the EC submissions  
7.152  The main or principal claims of the European  Communities raise an additional question, i.e. 
whether the European Communities alleges a violation of Article 23 of the DSU alone or of all the provisions cited in its submission in support of its claim of violation of Article 23. 
7.153  The Panel does not believe that the fact that the European Communities alleges a violation of 
Article 23 "read together with" or  "in conjunction with" other provisions implies that the European 
Communities does not raise any claim under Articles 3.7, 21.5 and 22.8 of the DSU. 
7.154  The Panel recalls that the request for estab lishment of a panel made by the European 
Communities refers to "Article 23.1;  23.2(a) and (c); 3.7; 22.8 and 21.5 of the DSU".  Thus, having 
regard to the definition of a claim referred to above , examining the conformity of Canada's measures 
with Articles 3.7, 21.5 and 22.8 of th e DSU is part of the Panel mandate. 
7.155  The Panel notes the argument of Canada that , were the Panel to adopt the interpretation 
advanced by the European Communities of the interplay between Article 23 of the DSU "in 
conjunction with" the various Articles of the DS U cited by the European Communities in its two 
claims, it would either impose on Canada an obligation that finds no textual basis in the DSU or 
remove Canada's right to act in accordance with  the DSB authorization to suspend concessions 
without further multilateral intervention by the DSB.
408  We recall that paragraph 1 of Article 31 of 
the Vienna Convention on the Law of Treaties, embodying the customary rules of interpretation of 
public international law referred to in Article 3.2 of the DSU, provides that: 
"A treaty shall be interpreted in good faith  in accordance with the ordinary meaning 
to be given to the terms of the treaty in their context and in the light of its object and 
purpose." 
7.156  The Panel does not exclude that there could be situations where the rights or obligations of 
Members could vary depending on which other provision a particular article of the DSU is read together with. However, either the terms of the provisions concerned interpreted in their ordinary 
meaning, in their context and in the light of the object and purpose of the treaty or the provisions 
support the claim, or they do not. Likewise, it is often the case that the violation of a particular provision will have consequences on the legality of the measure at issue under other provisions of the 
same or of other covered agreements. 
7.157  We note that, in US – Certain EC Products , the panel stated that: 
"Since we have already concluded that the 3 March Measure constituted a measure 
taken to redress a WTO violation (covered by Article 23.1), we proceed to examine 
whether the same 3 March Measure violated the provisions of the sub-paragraph 2(c) of Article 23 of the DSU, as well as Articles 3.7 and 22.6 of the DSU."
409 
7.158  In other words, it would appear that the panel in US – Certain EC Products , even though it 
considered the effects of a finding of violation of one  provision on the other – this is probably what it 
meant by "Article 23.1 together with Articles 23.2( c), 3.7 and 22.6 of the DSU" in the title of the 
section where the above quotation is found – neve rtheless made findings of violation of each 
                                                      
408 Canada's second written submission, para. 9. 
409 Panel Report on US – Certain EC Products , para. 6.36. WT/DS321/R 
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  provision individually. We note that, likewise, the Appellate Body assessed the panel findings on each 
provision separately.410  
7.159  While the European Communities see ms to insist on the violations of Article 23, the Panel 
does not believe that the terms "read together with /read in conjunction with" were meant to limit its 
findings of violation to Article 23. Rather, the European Communities is seeking findings on all the provisions cited but, because of the broadly cast wo rding of Article 23, the European Communities 
seeks to circumscribe the context in which that violati on is to be found.  In other words, it wants us to 
articulate any findings of violation of Article 23 with  the violations of Articles 21.5, 22.8 and 3.7 of 
the DSU. 
7.160  The Panel concludes that the fact that the European Communities is seeking findings of 
violation of Article 23 "read together with" or "r ead in conjunction with" should not be understood as 
meaning that the European Communities exclusively claims a violation of Article 23.  The Panel 
believes that its mandate includes Articles 21.5, 22.8 and 3.7 of the DSU.   
(d) Conclusion 
7.161  From the above we conclude that: 
(a) the indications given by the European Communities on how it wants this case to be 
addressed (main claims and alternative cl aim) are part of the Panel's mandate; 
(b) the indication by the European  Communities that certain provisions referred to in its 
request for establishment of the Panel be "read together" or "in conjunction with" 
does not mean that the Panel is not exp ected to make findings on each of these 
provisions.  
5. Approach of the Panel on the basis of its mandate 
7.162  We are mindful of the EC position that this case is primarily about alle ged violations of the 
DSU and, in particular, Article 23 thereof.  We note  in particular the EC argument that it brought this 
case because Canada refused to initiate a procedure under Article 21.5 of the DSU and did not agree 
to any other procedural arrangement.
411  We note that the European Communities also claims that 
Canada breaches Article 23 of the DSU read togeth er with Article 22.8 because it failed to withdraw 
its suspension of obligations in spite of the EC rem oval of the measure found to be inconsistent with a 
covered agreement. 
7.163  In our opinion, the EC claims of violation of Article 23.2(a) read together with Articles 21.5 
and 23.1 are not premised on compliance by  the European Communities with the DSB 
recommendations and ruling in the EC – Hormones  case, whereas the claims of violation of 
Article 23.1, read together with Articles 22.8 and 3. 7 of the DSU, are.  Indeed, the EC claims of 
violation of Article 23.2(a), read together with Articles 21.5 and 23.1 of the DSU are premised on the 
fact that the respondent would have maintained  a measure that could be deemed to be a 
"determination to the effect that a violation has occurred" without having recourse to dispute settlement in accordance with the DS U.  Such a determination could take place whether or not the 
European Communities has complied with the DSB recommendations and rulings in EC - Hormones .  
Comparatively, the second series of EC  claims is, to the extent that it includes Article 22.8, premised 
on  the requirement that the respondent measure can "only be applied until such time as the measure 
                                                     
 
410 Appellate Body Report on US – Certain EC Products , para. 106 et seq . 
411 See, e.g., EC's reply to Panel questions af ter the first substantive meeting, question 50, 
paras. 184-185.  WT/DS321/R 
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  found to be inconsistent with a covered agreement has been remo ved", as claimed by the European 
Communities.  Thus, addressing the second series of  main claims of the European Communities 
entails that we review the question of the presu med or actual compliance of the EC implementing 
measure with the DSB recommendations and rulings in the EC – Hormones  case.  
7.164  We believe that these two series of claims, as presented by the European Communities, are 
independent from each other and can be addressed co mpletely separately. However, while we are free 
to structure the order of our analysis as we see fit412, we see no reasons not to review the EC claims in 
the order followed by the European  Communities in its submissions.  We therefore proceed  now with 
the first series of claims raised  by the European Communities. 
B. FIRST SERIES OF EC CLAIMS : VIOLATION OF ARTICLE  23.2( A) READ TOGETHER WITH 
ARTICLES  21.5  AND 23.1 
1. Summary of the main arguments of the parties413 
7.165  The European Communities  argues that by maintaining its suspension of obligations, 
Canada is seeking redress of a perceived violation of  the WTO Agreement.  Pursuant to Article 23 of 
the DSU, any attempt to seek "redress" can take pl ace only pursuant to the rules and procedures of the 
DSU.  Canada's continued suspension of obliga tions is contrary to the specific prohibition of 
unilateral conduct set out in Article 23.2(a) of th e DSU. Instead, Canada should have introduced a 
compliance procedure under Article 21.5 of the DSU. By not doing so, Canada has violated the 
specific prohibition of unilateral conduct set out in Article 23.2(a) of the DSU. This violation of 
Articles 23.2(a) and 21.5 constitutes at the same time a violation of Article 23.1 of the DSU.414 
7.166  The European Communities, referring to the panel report in US – Section 301 Trade Act,  
notes that the following three conditions need to be fulfilled in order to find a violation of Article 23.2(a) of the DSU.  First, given the "chapeau " of Article 23.2, it needs to be established that a 
Member is seeking to redress a WTO violation. In the opinion of the European Communities, this is 
the case in this dispute.  Second, Article 23.2(a) of the DSU requires that a Member has made a "determination to the effect that a WTO violatio n has occurred." Such a d ecision need not have a 
specific form, and can be inferred from action.  The suspension of concessions or other obligations is 
the very means (albeit of last resort) of reacting to a violation and therefore necessarily implies a 
decision that there is a violation. The multilateral dete rmination at the origin of the current suspension 
of concessions by Canada was, however, made with respect to the measures previously applied by the 
European Communities. Logically, it could not an d did not apply to the measures subsequently 
adopted and properly notified to the WTO by the European Communities. If Canada continues to 
apply the suspension of concessions and related obligations, it necessarily implies that it has 
unilaterally determined that there continues to be a violation. It has, in ad dition, explicitly said so.
415  
Third, Article 23.2(a) of the DSU is violated if th e determination is not made in accordance with the 
rules and procedures of the DSU or is not consistent  with the findings of a dispute settlement organ. 
The DSU provides for a specific procedure, namely Article 21.5 of the DSU, to address the situation 
that Members disagree over the existence or cons istency of measures taken to comply with the 
recommendations and rulings of the DSB.416  
                                                      
412 Appellate Body Report on Canada – Wheat Export and Grain Imports , paras. 126-129. 
413 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report. The order in which the respective arguments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
414 EC's first written submission, para. 47. 
415 EC's first written submission, paras. 50-57. 
416 EC's first written submission, paras. 60-61. WT/DS321/R 
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  7.167  In the view of the European Communities, there exists obviously a disagreement as to 
whether or not, by adopting Directive 2003/74/EC, the European Communities has implemented the 
recommendations and rulings from the DSB in the EC – Hormones case. Article 21.5 of the DSU 
requires that that disagreement shall  be decided through recourse to dispute settlement.  To date, 
Canada has refused to initiate a compliance pr ocedure under Article 21.5 (or any other dispute 
settlement procedure under the DSU). Instead, it con tinues to apply the suspension of concessions and 
other obligations as if no "measure to comply" ha d been taken or the non-compliance of the new 
directive of the European Communities ha d already been multilaterally established.417 
7.168  Canada argues that it is not seeking the redress of a violation within the meaning of 
Article 23.1 of the DSU.  Canada considers that it already sought and obtained redress pursuant to the 
rules and procedures of the DSU for a violation by the European Communities of its WTO obligations.  An action taken pursuant to a multil ateral DSB authorization cannot amount to a 
unilateral determination.  Thus Ca nada has in no way acted inconsis tently with Article 23.1 of the 
DSU by failing to have recourse to, and abid e by, the rules and procedures of the DSU. 
7.169  Canada adds that its assessment concerning th e consistency of the EC implementing measure 
is irrelevant to Canada's continued suspension of  concessions. Canada's suspension of concessions is 
based on the ongoing validity of the DSB authoriza tion of 26 July 1999 and not on any views it has 
developed on the consistency of the EC current measure.
418 
7.170  Canada further argues that, in this case, it has not made a unilateral determination in 
contravention of Article 23.2(a) of the DSU.  Acco rding to Canada, it is clear from the text of that 
provision that it can only be seen to have made a unilateral determination where it is seeking the 
redress of a WTO violation. 
7.171  Canada recalls that, in interpreting the meaning of the term "determination" in the context of 
Article 23.2(a) of the DSU, the panel in US – Section 301 Trade Act  found that "a 'determination' 
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 take n by another Member." On the basis of this 
interpretation, the Panel then specified that mere  opinions or views expressed by a Member before 
that Member reaches the decision to seek redress of the inconsistency, are not intended to be covered 
by Article 23.2(a).  Canada argues that, in th e current case, it has not passed the threshold of a 
"determination" regarding the EC current measure.  Canada recalls that, on several occasions it has 
stated that it was prepared to discuss with th e European Communities the WTO consistency of its 
current measure. 
7.172  Canada claims that it is the responsibility of the European Communities to establish that it has 
complied with the DSB's recommendations and rulings. In accordance with this view, Canada stated 
in the DSB that it sees no reason to initiate WTO proce dures or to take any other action at this time.419  
7.173  As far as the EC claim under Article 21.5 is concerned, Canada argues that the European 
Communities was perfectly free to have r ecourse to Article 21.5. In fact, in EC – Bananas III 
(Article 21.5 – EC) , it sought to do precisely that.  Recourse to Article 21.5 of the DSU by the 
European Communities would have been the mo st appropriate mechanism under the DSU for 
obtaining a multilateral determination of compliance or non-compliance of the EC current measure.  
The European Communities' own failure to invoke th is provision, however, is not a legitimate basis 
for a claim that Canada acted unilaterally by not invoking Article 21.5 of the DSU. Nor does it absolve the European Communities of its responsibility  to demonstrate in appropriate procedures that 
                                                     
 
417 EC's first written submission, paras. 62-66. 
418 Canada's first written submission, paras. 67-70. 
419 Canada's first written submission, paras. 71-75.  WT/DS321/R 
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  it has brought itself into compliance, should it wi sh to have the DSB authorization of Canada's 
suspension of concessions terminated. 
7.174  Canada considers that, if the Panel were to ad opt the EC's interpretation of the relationship 
between Articles 22.8, 23 and 21.5 of the DSU, Canada would be obliged in the current circumstances, on the basis of the EC unilateral and unproven assertions of compliance, to lift its 
suspension of concessions and initiate dispute settle ment proceedings under Article 21.5.  Such an 
interpretation would put into question a WTO Memb er's ability to rely on a validly obtained DSB 
authorization to suspend concessions and seriously  undermine the proper functioning of the dispute 
settlement system in the WTO. 
7.175  Canada considers that the European Communities is under an ongoing obligation to comply 
with the recommendations and rulings of the DSB.  The EC unilateral declaration of compliance 
cannot somehow place the onus on Canada to launc h proceedings under Article 21.5 of the DSU.
420 
7.176  According to the European Communities , the very fact of applying sanctions implies that a 
Member is seeking to redress a violation. And this  in turn implies that this Member has made a 
"determination" about the WTO-inconsistency of th e measure. The application of these sanctions may 
be justified if a measure by a Member has been pr operly found to be WTO-inc onsistent and if, on that 
basis, the DSB authorizes the suspension of concessions. However, the European Communities 
asserts, the situation is different regarding the continuation of sanctions in the presence of a 
compliance measure which the DSB has not found to be WTO-inconsistent. A DSB authorization 
which has been granted in view of an original WT O-inconsistent measure cannot justify the continued 
application of sanctions against a different me asure which has never been found multilaterally to 
constitute a WTO violation.421 Rather, since the application of sanctions requires a causal relationship 
to a WTO-inconsistent measure it is clear that any pr esent application of sanctions by Canada must be 
linked to a present EC measure, namely, its implemen ting Directive. Conversely, it is logically not 
possible to justify the present application of sanctio ns to a past and no longer existent measure. Thus, 
the continuation of the sanctions is a continui ng act of "seeking redress".  To accept Canada's 
argument would lead to the result that Canada coul d continue to apply sanc tions irrespective of any 
events occurring after the DSB authorization. 
7.177  The European Communities adds that, since Cana da submits that the original purpose of its 
sanctions has not changed, it argues that the EC  compliance measure is still inconsistent. This 
undermines the credibility of Canada's argument th at it applies sanctions only because of the DSB 
authorization. 
7.178  The European Communities considers that, re garding the notion of "seeking redress" under 
Article 23, Canada's action fits precisely into th e jurisprudential definition that a Member act "in 
response to a perceived violation by another Memb er of that Member's WTO obligations". Since 
Canada has officially stated that it considers the EC compliance measure as WTO inconsistent and 
since it applies sanctions against a perceived viol ation (which in this case can only be the EC 
compliance measure since the original measure does not exist any more) the conditions of the above 
definition under Article 23 are fully met.  
7.179  In this context, the European Communities cons iders that Canada has also met the threshold 
of a unilateral "determination" in violation of Artic le 23.2(a) of the DSU. The term "determination" 
has been elaborated by the panel in US – Section 301 Trade Act  which considered that what is 
decisive under Article 23.2(a) is not so much whet her an act constitutes a "determination", which was 
in the view of the panel "a more or less formal re quirement that needs broad reading", but whether it 
                                                      
420 Canada's first written submission, paras. 76-82. 
421 EC's first oral statement, paras. 27 et seq.  WT/DS321/R 
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  is consistent with the DSU rules and procedures.   The European Communities concludes from this 
finding that even an implicit determination by the appropriate behaviour, such as the continuation of 
sanctions, would be covered by a "broad reading" of this requirement, in particular if the continuation 
occurs deliberately and is accompanied by statements. 
7.180  In this respect the European Communities firs t notes that all relevant elements should be 
taken into account to assess whether a Member makes a unilateral determination of a violation when 
he seeks to redress a situation. Not every policy st atement may be equal to a "determination" of a 
violation or made with the purpose of "seeking a redress of a violation" but, if a WTO Member repeatedly and consistently states that a violation by another Member exists and, in this context, this 
Member applies concrete measures against the other Member, it can be concluded that this Member is seeking a redress against a violation on the basis of  a unilateral determina tion.  Applying these 
principles to the present case, there can be no doubt that Canada has made a unilateral "determination" 
of non-compliance of the EC measure. 
7.181  Second, the European Communities notes that, in  addition to its recurrent statements 
regarding the WTO-inconsistency of the EC compliance measure, Canada continues  to apply 
sanctions against the European Communities. Both its public statements and its actions are fully 
coherent and they demonstrate that Canada has i ndeed made a "determination" of an alleged WTO 
violation by the EC compliance measure. 
7.182  The European Communities also sees merits in China's argument that the time-factor may be 
relevant for assessing when a "determination" actua lly has been made.  The European Communities 
made a similar argument when pointing to the reasonable time frame in which an implementing 
Member can expect the other Party to bring an  Article 21.5 proceeding. This argument does not 
ignore that this specific case raises complex scientif ic questions but up until  now Canada had five 
years to consider these questions since the Europ ean Communities first notified its draft proposal to 
the SPS Committee. 
7.183  According to the European Communities, Cana da has not been able to offer any legal 
arguments on why the continued application of sanc tions is not violating Article 21.5 in conjunction 
with Articles 23.1 and 23.2(a) of the DSU.  Th e obligation to initiate a compliance review under 
Article 21.5 of the DSU is linked to Canada's co ntinued application of sanctions against the EC 
compliance measure. Because of this, Canada is  under a positive obligation to bring a compliance 
proceeding against the EC measure. By not doing so Canada violates Ar ticle 23 of the DSU. Thus, in 
this specific situation, Canada's discretion regarding whether or not it is appropriate to initiate WTO 
proceedings is limited as the failure to do so au tomatically encroaches on the EC rights not to be 
exposed to sanctions for a measure which anot her WTO Member unilaterally determines as WTO-
inconsistent.  Whereas a Member in violation of its WTO obligations is under an active obligation to 
comply, the retaliating Member is under an active obligation to initiate a compliance review under 
Article 21.5 of the DSU. Failure to do so will result in  a violation of Article 23. 1, 23.2(a), 21.5 of the 
DSU. 
7.184  With respect to Canada's comments regarding a self-initiated Article 21.5 review by the 
European Communities, the European  Communities recalls that it is not possible or meaningful to 
initiate a compliance review against its own implementing measure. The DSU is based on a 
contradictory proceeding whereby a complaining part y alleges a WTO-violation against another party. 
Conversely, the DSU does not provide for a situation where a "complaining party" alleges the WTO-consistency of its own measure, in  particular to prove the negative that is that its measure is not WTO-
inconsistent. 
7.185
 Canada  considers that Article 21.5 creates a right to initiate compliance proceedings, not an 
obligation. Nor can the other provisions of the DSU cited by the EC be interpreted to compel Canada,  WT/DS321/R 
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  in the circumstances of this case,  to initiate proceedings to challe nge the EC's purported implementing 
measure and to suspend the application of Canada's  measure pending the outcome of that proceeding. 
7.186  Canada notes that the European Communities adm its that Article 23 of the DSU applies only 
when Members "seek redress" of a WTO violation. Canada  is of the view that it cannot be found to be 
violating Article 23 of the DSU by continuing to suspend concessions in the absence of some 
intervention by the DSB that would either explicitl y or implicitly terminate the DSB authorization. 
The fact that Canada continues to suspend concessi ons under such authority, even in the face of a 
purported implementing measure by the European  Communities, does not render Canada's conduct 
inconsistent with Article 23 of the DSU. In these circumstances, Canada has taken no action to "seek 
redress" for any alleged WTO inconsistency of th e EC implementing measure.  The EC adoption and 
subsequent notification to the DSB of its purpor ted implementing measure cannot change the legal 
basis of Canada's continued suspension of concessions. 
7.187  Canada states that its continued suspension of concessions is not aimed at remedying any 
alleged violations of the EC implementing measure.  Canada's conduct continues to be based on the 
DSB authorization and is therefore not based on Ca nada's views regarding the non-compliance of the 
EC's implementing measure. Conse quently, Canada is acting in a manner fully consistent with 
Article 23 of the DSU. 
7.188  Canada has not acted inconsistently with Artic le 23.2(a) of the DSU because it has not made a 
unilateral determination regarding the EC's implemen ting measure.  Given that Canada is not "seeking 
redress" for perceived WTO violations of the EC implementing measure, Cana da cannot have made a 
"determination" within the meaning of Article 23.2(a) of the DSU.  The EC's claim in this regard must 
fail. 
2. Reasoning of the Panel 
(a) Introduction 
7.189  The European Communities claims a violation of Article 23.2(a), read together with 
Articles 21.5 and 23.1. Article 23.2(a) contains speci fic obligations compared with Article 23.1. We 
therefore deem it relevant to address the violation of Article 23.2(a) first.422  
7.190  Article 23.2(a) reads as follows: 
"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, ex cept through recourse to dispute settlement 
in accordance with the rules and procedur es of this Understanding, and shall make 
any such determination consistent with the findings contained in the panel or 
Appellate Body report adopted by the DS B or an arbitration award rendered under 
this Understanding;" 
                                                      
422 We note in this respect that, as mentioned by the Appellate Body in Canada – Wheat Export and 
Grain Imports , paras. 126-129: 
"As a general principle, panels are free to structur e the order of their analysis as they see fit.  
In so doing panels may find it useful to take account of the manner in which a claim is 
presented to them by a complaining Member. Furthermore, panels may choose to use 
assumptions in order to facilitate re solution of a particular issue ..." 
 WT/DS321/R 
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  7.191  In order to decide whether Canada has or h as not breached Article 23.2(a) in this case, the 
Panel must first find whether the determination was made "in such cases", i.e. when the conditions of 
Article 23.1 are met. 
7.192  Article 23.1 reads as follows: 
"When Members seek the redress of a violation of obligations or ot her nullification or 
impairment of benefits unde r 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." 
7.193  In other words, the Panel must first establish wh ether Canada, in relation to the facts of this 
case, has been seeking redress of a violation of oblig ations or other nullifica tion or impairment of 
benefits under the covered agre ements, within the meaning of Article 23.1 of the DSU. 
7.194  Thereafter, the Panel will proceed with determining whether Canada has breached 
Article 23.2(a).  Once this is done, it will review the alleged violation of Articles 21.5 and 23.1, as 
necessary. 
(b) "[S]eeking the redress of a violation of obliga tions or other nullification or impairment of 
benefits under the covered agreemen ts" (Article 23.1 of the DSU) 
7.195  Canada argues that it has taken no action to "seek redress" for any alleged WTO 
inconsistency of the EC implementing measure.  Th e EC adoption and subsequent notification to the 
DSB of its purported implementing measure cannot ch ange the legal basis of Canada's continued 
suspension of concessions. Canada states that its c ontinued suspension of concessions is not aimed at 
remedying any alleged violations of the EC implem enting measure.  Canada's conduct continues to be 
based on the DSB authorization and is therefor e not based on Canada's views regarding the non-
compliance of the EC implementing measure.   
7.196  We agree with Canada that Article 23.1 of the DSU is not breached when a Member's 
suspension of concessions or other obligations has been multilaterally authorized by the DSB, because 
the Member concerned "ha[d] recourse to, and abid e[d] by, the rules and procedures of [the DSU]", 
within the meaning of Article 23.1.  Indeed, Cana da already sought redress against the original EC 
ban under the DSU.   
7.197  In the opinion of the Panel, Article 23.1 a pplies in this case only with respect to a 
determination against a measure which has not ye t been subject to a recourse to the rules and 
procedures of the DSU.  We must therefore dete rmine first whether Directive 2003/74/EC is such a 
measure. 
7.198  We note the arguments of the European Commun ities that it adopted a new directive which it 
considers implements the recommendations and rulings of the DSB in the EC – Hormones  case.423  
We first recall that Directive 2003/74/EC has never been as such subject to recourse to the rules and 
procedures of the DSU by Canada.  For instance, no panel has been established at the request of 
Canada to review the conformity of Directive 2003/74/EC with the covered agreements.  Second, 
Canada does not argue that Directive 2003/74/EC is identical to the measure that was found in breach of the SPS Agreement  in the EC – Hormones  case.  The fact that both parties consider that the EC 
implementing measure is not the same measure as that which was found in breach of the WTO Agreement by the DSB in the EC – Hormones  case is confirmed by the allegations they made in 
relation to that implementing measure before this Panel.  The European Co mmunities considers that 
                                                     
 
423 EC's first written submission, para. 17.  WT/DS321/R 
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  its ban on oestradiol-17 β is compatible with Article 5.1 of the SPS Agreement , whereas its ban on the 
other five hormones is justified by Article 5.7.  Canada alleges, inter alia , the incompatibility of the 
ban on oestradiol-17 β with Article 5.1, and of the provisi onal ban on the other five hormones with 
Article 5.7.  These are different provisions than those invoked in the EC – Hormones  case with 
respect to the same hormones.424  Thus, by arguing as it does in this case, Canada implicitly 
acknowledges that the measure at issue is different from the original measure found in breach of the 
WTO Agreement both legally and in substance, ev en though an import ban on meat treated with 
hormones for growth promoti on purposes is still applied. 
7.199  We are aware of the fact that the original ban remains in force.  We consider, however, that 
this is insufficient to conclude that Directive 2003/ 74/EC is not different from the measure originally 
found in breach of the WTO Agreement and should be deemed for that reason to have been subject to 
the rules and procedures of the DSU.  We recall that it is not the ban on meat treated 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.  The European Communities is not prevented by the 
SPS Agreement  from imposing any ban on import of meat treated with growth promotion hormones.  
The European Communities can impose such a ban pr ovided it is compatible with the relevant 
requirements of the SPS Agreement .  As a result, the Panel does not c onsider that the fact that the ban 
remains in place means that no new measure has been adopted. 
7.200  Canada argues that its measure, taken on the basis of a DSB authorization, is by definition 
WTO-consistent. As Canada's measure is authorized  by the DSB, it is the DSB that must determine 
whether the conditions exist for the termination of that authorization.425  Canada adds that its 
continued application of a measure suspending con cessions that is duly authorized by the DSB cannot 
at the same time be construed to be a conduct inc onsistent with Article 23 of the DSU simply because 
the European Communities has adopted a measure th at it, and it alone, now claims brings it into 
compliance.426 
7.201  We agree with Canada that it was authorized  by the DSB to suspend concessions and that this 
authorization has not been revoked. We note however, that this is only an authorization , not an 
obligation  imposed by the DSB.  The Panel agrees with  the European Commun ities in this respect: 
"authorization by the DSB" does not mean "obligati on to suspend concessions". This is confirmed by 
the practice under the DSU pursuant to which, in a number of cases where authorizations to suspend 
concessions have been requested, no suspensions w as subsequently applied, in spite of the DSB 
authorization.427  In other words, the fact that, after the notification of Directive 2003/74/EC, Canada 
continues to apply its suspension of concessions ev en though it has no obligation to do so is evidence 
that Canada is actively "seek[ing] the redress of a violation of obligations or other nullification or 
impairment of benefits under  the covered agreements". 
7.202  We note that the DSU does not provide for any procedure regarding the revocation of an 
authorization to suspend concessions.  The adoption of  a decision to revoke such an authorization by 
the DSB would require consensus428, which would in turn require an absence of objection from the 
Member suspending concessions or other obligations, which may be di fficult to obtain. We consider 
that this is not necessary, essen tially because the DSB grants an authorization, which the Member 
                                                      
424 In the original EC – Hormones  dispute, the panel noted the European Communities had explicitly 
stated that its measures are not provisional measures in the sense of Article 5.7 of the SPS Agreement .  See 
Panel Report on EC – Hormones (Canada),  para. 8.252.   
425 Canada's first written submission, para. 41. 
426 Canada's second written submission, para. 12. 
427 In the Brazil – Aircraft  case, and Canada – Aircraft  Credits and Guarantees  case, the DSB 
authorized Canada and Brazil to suspend concessions, but neither of them applied the authorization.  In EC – 
Bananas III  case, Ecuador was authorized to suspend concessions but did not exercise that right. 
428 See Article 2.4 of the DSU. WT/DS321/R 
Page 174 
 
 
  concerned is free to apply or not.  We also note that Article 22.8 of the DSU does not provide for any 
decision of the DSB for a suspension of concessions or  other obligations to cease to apply.  The first 
sentence of Article 22.8 simply provides that:  
"The suspension of concessions or other oblig ations shall only be applied until such 
time as  the measure found to be inconsistent  with a covered agreement has been 
removed, or the Member that must impl ement recommendations or rulings provides a 
solution to the nullification or impairment of benefits or a mutually satisfactory solution is reached." (Emphasis added) 
7.203  In none of the circumstances foreseen by Article  22.8 does this provision require a decision of 
the DSB.  In other words, it is for the respondent in  this case to take appropriate steps to ensure that 
the suspension of concessions or other obligations  is only applied until such time as foreseen in 
Article 22.8. 
7.204  We also note that, pursuant to Article XVI:4  of the Agreement Establishing the WTO, 
Members must ensure the conformity of their laws, regulations and administrative procedures with 
their obligations as provided in the agreements annexed to the Agreement Establishing the WTO, 
including the DSU. 
7.205  We conclude that Canada does not need a mu ltilateral decision in order to terminate the 
suspension of concessions or other obligations for which it got authorization from the DSB.  
7.206  For the reasons stated above, we consider that the EC implementing measure is, compared 
with the measure for which Canada was granted authorization to suspend concessions and other 
obligations by the DSB, a measure which has not  been subject to a recourse to the rules and 
procedures of the DSU. 
7.207  Canada, by maintaining its suspension of con cessions even after the notification of the EC 
implementing measure, is seeking redress of a violation with respect to the EC implementing 
measure, within the meaning of Article 23.1 of th e DSU.  If it were not, as mentioned above, Canada 
would not have to maintain that suspension. 
7.208  We now proceed to assess whether Canada breached Article 23.2(a). 
(c) Violation of Article 23.2(a) 
(i) Introduction 
7.209  In order to assess whether Canada breaches Article 23.2(a), we must review the following 
conditions:
429 
(a) whether Canada made a determination that the EC implementing measure violates the 
WTO Agreement; 
(b) whether Canada failed to make such de termination through recourse to dispute 
settlement in accordance with th e rules and procedures of the DSU; and assuming that 
it did, 
                                                      
429 We note that a similar approach was applied by the Panel in US – Section 301 Trade Act , 
footnote 657.  WT/DS321/R 
 Page 175 
 
 
  (c) whether Canada failed to make any such de termination consistent with the findings 
contained in the panel or Appellate Body re port adopted by the DSB or an arbitration 
award rendered under th is Understanding. 
7.210  We will review these requirements successively. 
(ii) Did Canada make a determination that the EC implementing measure violates the WTO 
Agreement? 
7.211  We note that, in the present case, the European Communities notified its implementing 
measure on 27 October 2003.430  At the DSB meeting of 7 November 2003 Canada made the 
following statement: 
"The representative of Canada  said that the EC's communication to the DSB noted 
that the Directive 2003/74/EC "implement s the WTO rulings" and the "... suspension 
of concessions to the EC by United States and Canada in this dispute are no longer 
justified".  Canada had still seen no scientific  basis for the ban.  Health Canada had 
conducted a comprehensive review of the 17 new studies and had concluded that they 
did not provide any new scientific evidence th at residues in meat from animals treated 
with steroid hormones – according to good veterinary practices – posed a threat to 
human health.  Canada did not see any reason for WTO procedures at this time, but 
would welcome the opportunity for further discussion with the EC concerning the justification for its measures."
431 
7.212  Canada made another statement at th e DSB meeting of 1 December 2003: 
"The representative of Canada  said that, at the 7 November DSB meeting, Canada 
had put forward a suggestion for bilateral discussions concerning the justification for the EC's position that it had complied with the WTO ruling.  However, the EC had 
not responded to Canada's suggestion for fu rther bilateral discussions.  Canada said 
that it was for the EC to establish that it had complied with the WTO rulings and 
continued to be open to discussions with th e EC regarding its justification for its 
position.  At this point, howe ver, Canada did not see any basis for the removal of its 
retaliation measures nor for taking any other action."
432 
7.213  Article 23.2(a) refers to "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".  Canada's position at the time of its statement before the DSB was 
clear as to the scientific justification of the EC measure , as illustrated by the following remark:  
"Canada had still seen no scientific basis for the ban.  Health Ca nada had conducted a 
comprehensive review of the 17 new studi es and had concluded that they did not 
provide any new scientific evidence that r esidues in meat from animals treated with 
steroid hormones – according to good veterina ry practices – posed a threat to human 
health."433 
                                                      
430 WT/DS48/20. 
431 WT/DSB/M/157, para. 31. 
432 WT/DSB/M/159, para. 24. 
433 WT/DSB/M/157, para. 31. WT/DS321/R 
Page 176 
 
 
  7.214  However, Canada did not expressly state that  the EC implementing measure violated a 
covered agreement, or nullified or impaired benefits, or impeded th e attainment of any objective of 
the covered agreements. 
7.215  We recall that the Panel in US – Section 301 Trade Act  defined a "determination" as follows: 
"[W]e consider that – given its ordinary meaning – a "determination" 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."434 
7.216  We will therefore proceed to determine whether other elements of Canada's statements or 
attitude could be evidence that Canada actually made a determination  in respect of the WTO 
consistency  of the EC implementing measure. 
7.217  We first note that, given the importance of the scientific justification of the implementing 
measure for its conformity with the SPS Agreement , Canada's statement that it had not seen any 
scientific basis for the EC ban is quite close to  stating that the implementing measure is not 
compatible with the SPS Agreement . 
7.218  Second, this statement has to be read in conj unction with the other intervention of Canada at 
the DSB meeting of 7 November 2003 where Canada's re presentative stated that "he wished to clarify 
that he had stated officially that Canada  was not removing the retaliatory measures."435 Canada further 
clarified its position at the DSB meeting of 1 December 2003 where it mentioned that it "did not see any basis for the removal of its retaliation measures nor for taking any other action." 
7.219  Canada did not specify that it saw no legal  basis for the removal of its retaliation measures. 
However, this is implicit since Canada refers to " any basis", which means that it also saw no legal  
basis, in addition to no scientific basis, for removi ng the measure.  Combined with Canada's statement 
about the scientific justification of the measure, this statement strongly suggests that Canada took a position on the WTO consistency of the impl ementing measure notified by the European 
Communities. 
7.220  The next question is whether this constitut es a "determination" within the meaning of 
Article 23.2(a) of the DSU.  The Panel is mindful of the definition of "determination" found in the 
panel report on US – Section 301 Trade Act and it is necessary to assess whether the consideration of 
the legality of the EC implementing measure as it resu lts from Canada's statements is such that it can 
be reasonably deemed to convey, with a high degree of firmness and immutability, an apparently final 
conclusion as to the WTO compatibility of the EC measure. 
7.221  The Panel first notes that nowhere in Canada's statements is there any indication that such 
statements were provisional, that Canada was still reviewing the EC implementing measure, or that it 
was expecting more informati on or planning to seek more information from the European 
Communities on the scientific justification of the measure.  On the contrary, its conclusions as to the 17 studies are cast in definitive terms.  As far as the legality of the implementing measure is 
concerned,  the Panel notes that Canada officially  stated that it was not removing the retaliatory 
                                                     
 
434 Panel Report on US – Section 301 Trade Act , footnote 657. 
435 WT/DSB/M/157, para. 33.  WT/DS321/R 
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  measures and that is saw no basis for their removal or for taking any other action.436  The Panel notes 
that there is no condition or qualification attached to these statements.  
7.222  We note that the statements quoted above sugg est that Canada was ready to engage into 
bilateral discussions concerning the justification for the EC position that it had complied with the 
WTO ruling and that Canada would have made a proposal to that effect at the DSB meeting of 7 November 2003. The Panel notes that, in response to one of its questions, the parties specified the 
extent of the consultations that took place afte r the notification of Directive 2003/74/EC.  The Panel 
notes that they largely related to procedural issues.
437  In any event, even if Canada were ready to 
discuss the legality of the EC implementing measure, it officially stated that it was not removing its retaliatory measures, which has all the characteristics of a definitive decision.  In the view of the 
Panel, since suspending concessions or other obligati ons is the consequence of the non withdrawal of 
a measure found to be WTO inconsistent
438, this statement implicitly meant that Canada had reached a 
decision that the EC implementing measure was not WTO consistent. 
7.223  We therefore consider that Canada's statement meets all the requirements of the definition in 
the Panel Report on US – Section 301 Trade Act  and that Canada made a "determination" within the 
meaning of Article 23.2(a).  
7.224  Even if one were to consider that Canada's statements at the DSB were provisional comments, 
the subsequent continuation of the suspension of  concessions by Canada without alteration and 
without saying that it was still studying the EC impl ementing measure is evidence that the statements 
before the DSB meant that Canada had no intention to remove its retaliatory measure, at least until 
further notice.  We note in this respect that th e term "determination" does not necessarily imply a 
formal decision439, all the more so as such a formal decision was not necessary in order to continue the 
suspension of concessions.  The continuation of th e suspension of concessions corroborates the fact 
that Canada's statements before the DSB constit uted a "determination" within the meaning of 
Article 23.2(a) of the DSU. 
7.225  Canada argues that Article 23.1 and 23.2(a) ca nnot impose on Canada an obligation to have 
recourse to dispute settlement with regard to the EC implementing measure.  According to Canada, 
this would deprive it, without any multilateral interv ention, of its right to act in accordance with a 
validly obtained multilateral aut horization to suspend concessions. 
7.226  Canada adds that its continue d application of a measure suspending concessions that is duly 
authorized by the DSB cannot at the same time be  construed to be a cond uct inconsistent with 
Article 23 of the DSU simply because the EC has ad opted a measure that it, and it alone, now claims 
brings it into compliance. 
7.227  As already mentioned above, the authorization to suspend obligation granted by the DSB is an 
authorization , not an unfettered right.  Article 22.6 of the DSU has to be read in its context, which 
includes, inter alia , Articles 22.8, 23 and 3.7 of the DSU and Article XVI.4 of the WTO Agreement. 
Whereas the DSU could have envisaged a formal decisi on of the DSB to terminate an authorization to 
suspend concessions, this is not the case.  Yet, th e DSU provides that suspension of concessions "shall 
be temporary" (Article 22.8).  Article 23.1 instru cts WTO Members not to seek redress of a violation 
                                                      
436 The two statements quoted above we re also delivered by an official  of the Canadian government at a 
formal meeting of a WTO body. There is no difference between that statement and any other statement where a 
formal decision of a Member is conveyed to the DSB. 
437 See parties' replies to questions after the fi rst substantive meeting, question 50, Annex B-1, 
Annex B.3. 
438 See, inter alia , Article 3.7 of the DSU. 
439 Panel Report on US – Section 301 Trade Act , footnote 657. WT/DS321/R 
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  without having recourse to, and abiding by, the rule s and procedures of the DSU. Article 3.7 makes 
the possibility to suspend the application of c oncessions or other obligations subject to the 
authorization of the DSB.  Article XVI.4 of th e WTO Agreement requires that each Member ensure 
the conformity of its laws, regul ations and administrative procedures with its WTO obligations.  In 
other words, like in all aspects of public intern ational law, WTO Members are expected to comply 
with their obligations under the DSU in good faith.  This implies that a WTO Member may be called 
upon to take appropriate measures in the absence of  any instruction from a multilateral body and even 
though it enjoyed until then the right to take other measures, if the circumstances change.  This is the 
case with the suspension of concessions or other ob ligations if a Member notifies a measure which 
compatibility with the DSU has not yet been subj ect to a multilateral ruling under the rules and 
procedures of the DSU. 
7.228  Indeed, the question before us in the context of Article 23.2(a) is not whether the European 
Communities has actually removed the measure found to be inconsistent, but  whether it notified a 
measure which has not yet been subject to dis pute settlement.  As noted above, the European 
Communities notified a new piece of legislation and Canada itself recognizes that the measure is 
different and challenges its legality on different le gal and factual grounds than it challenged the 
legality of the original measure for which it receive d an authorization to suspend concessions or other 
obligations from the DSB.  Since this is a diffe rent measure, it is logical under Article 23 that 
Canada's prior authorization to suspend concessions or other obligation do not apply to this measure. 
7.229  Canada considers that the EC argument that a notification of a new measure is sufficient to 
invalidate the DSB authorization to suspend co ncessions, if accepted, would allow the simple 
adoption and notification by one Member of a "c ompliance measure" automatically to render WTO-
inconsistent an otherwise WTO- consistent measure of another Member. Under such a regime, a 
Member against whom suspension of concessions has been authorized could buy itself considerable 
periods of relief through the announcement of a meas ure that barely differed from the one originally 
found to be inconsistent with its  WTO obligations. This would clearly not contribute to the objectives 
of inducing prompt compliance and ensuring the secu rity and predictability of the multilateral trading 
system. 
7.230  First, we believe that not only scam legisla tion, but also any other implementing measures 
could lead to recurrent litigations.  One could envi sage that, in a complex case, a Member could notify 
in good faith an implementing measure which would be  subsequently found not to fully comply with 
the original recommendations and ruling of the DSB.  This Member would have to submit a revised 
measure which could, once again, be challenged and found to comply only partly with the covered 
agreements.  Such repeated inconsistencies coul d have to do with the fact that, pursuant to 
Article 19.1 of the DSU, panels and the Appella te Body may only recommend that the Member 
concerned bring its legislation into conformity w ith the covered agreement(s) found to be breached, 
and may only make non-binding suggestions regard ing ways in which the Member concerned could 
implement their recommendations. Since Members remain free to implement recommendations and rulings as they deem appropriate, differences in th e interpretation of the recommendations of the DSB 
cannot be excluded, which can result in old inconsis tencies remaining in the implementing measure or 
in new ones creeping into it. 
7.231  Second, we recall that our findings are limited to the facts of this particular case. In this case, 
the European Communities has adopted Directiv e 2003/74/EC at the outcome of a lengthy and 
complex internal decision-making process.  The Pa nel notes in this respect that the Commission 
proposal was submitted in 2000 and 2001 and that th e procedure for the adoption of the Directive was 
the procedure provided for in Article 251 of the Treaty establishing the European Community.  This 
procedure involved a number of steps, including an Opinion of the European Parliament (1 February 
2001), a Common Position of the Council of the Eur opean Union (20 February 2003) and finally a 
Decision of the European Parliament (2 July 2003) , a Decision of the Council of the European Union  WT/DS321/R 
 Page 179 
 
 
  (22 July 2003) and an adoption by the European Parliament and the Council of the European Union 
on 22 September 2003.440  Without prejudice to the question whether Directive 2003/74/EC is actually 
based on the three opinions of the Scientific Co mmittee on Veterinary Measures relating to Public 
Health (SCVPH) of 1999, 2000 and 2002441 within the meaning of the SPS Agreement , the Panel 
notes that this Directive expressly refers to those opinions442 and that, as a result, they were part of the 
process that led to the adoption of the Directive.  The Panel also notes the efforts of the European 
Communities to have the conformity of its measure reviewed under the DSU.443  Even if the EC 
implementing legislation were ultimately found not to comply with the SPS Agreement , the Panel 
considers that it shows all the signs of an implem enting measure having gone through all the formal 
process required for its adoption and showing, on its face, all the signs  of a measure adopted in good 
faith.  
7.232  We therefore conclude that Canada made a "determination" within the meaning of 
Article 23.2(a)  in relation to Directive 2003/74/EC. 
(iii) Did Canada fail to make such determinatio n through recourse to dispute settlement in 
accordance with the rules a nd procedures of the DSU? 
7.233  We note that Canada argues that it has not made any determination  in respect of the EC 
implementing measure and therefore did not have  to have recourse to the dispute settlement 
procedures of the DSU.  However, we found above th at it made a determination within the meaning of 
Article 23.2(a).  Therefore, we c onclude that Canada ma de a determination without having recourse to 
the DSU, thus breaching Article 23.2(a) of the DSU. 
7.234  Canada also argues that it benefits from a multila teral authorization to suspend concessions in 
relation to the breach by the European Communities of the SPS Agreement , as a result of the 
recommendations and rulings of the DSB in the EC – Hormones  case.   
7.235  This is not the issue, however.  The issue is whether the authorization to suspend concessions 
or other obligations granted to Canada under Article 22 of the DSU amounts to a multilateral 
determination of inc onsistency of the EC implementing measure  (i.e. Directive 2003/74/EC) with the 
covered agreements through recourse to the DSU.   In our opinion, the answer is no.   
7.236  We therefore conclude that Canada  has not made any determination through recourse to 
dispute settlement  in accordance with the rules and procedures of the DSU. 
(iv) Did Canada fail to make any such determination c onsistent with the findings contained in the 
panel or Appellate Body report adopted by th e DSB or an arbitration award rendered under 
the DSU 
7.237  Since Canada has not made any determinati on through recourse to dispute settlement in 
accordance with the rules and procedures of the DSU, we conclude a fortiori  that Canada has failed to 
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 the DSU . 
                                                      
440 See Directive 2003/74/EC, Preamble and footnote 3. 
441 Hereafter the "1999 Opinion", the "2000 Opinion" and the "2002 Opinion" or, together, the 
"Opinions". 
442 See Directive 2003/74/EC, whereas clauses 5 and  8. 
443 See EC's replies to Panel questions after the first substantive meeting, question 50, Annex B-1. WT/DS321/R 
Page 180 
 
 
  (v) Conclusion 
7.238  For the reasons stated above, we find that Cana da has breached Article 23.2(a) of the DSU. 
(d) Violation of Article 21.5 of the DSU 
7.239  We note that the European Co mmunities claims that Canada should have had recourse to 
Article 21.5 of the DSU and that Canada's unilate ral determination that the European Communities 
has not implemented the recommendations and rulings of  the DSB is inconsistent with Article 21.5.  
Canada does not contest that the mechanism in Artic le 21.5 was available to the parties to obtain a 
determination under the DSU as to whether the EC meas ure is in compliance with the EC obligation.  
Canada argues, however, that it is not obligated to  initiate a compliance procedure under Article 21.5. 
7.240  We note that Article 23.2(a) provides that a determination must not be made "except through 
recourse to dispute settlement in accordance with [the DSU]". It does not specify which procedure 
under the DSU should be followed.  While the pro cedure under Article 21.5 of the DSU could be one 
of the mechanisms available, in our view, the te rm "recourse to dispute settlement in accordance with 
the rules and procedures of this Understanding" en compasses any of the means of dispute settlement 
provided in the DSU, including consultation,  conciliation, good of fices and mediation. 
7.241  The last proposition of Article 23.2(a) provides that such determinati on shall be consistent 
with the "findings contained in the panel  or Appellate Body  report adopted by the DSB or an 
arbitration award  rendered under this understanding."444  We do not consider, however, that that 
proposition requires  that Members have recourse to a panel or to arbitration.  In the opinion of the 
Panel, the last proposition of Article 23.2(a) only requires the Member which decides to have recourse 
to a panel or to arbitration  to abide by the recommendation of the panel or the Appellate Body or the 
award of the arbitrator.445   
7.242  As a result, we do not find it necessary to ma ke a finding on whether Canada breached 
Article 21.5 by not having recourse to the proce dure under that provision.  Indeed, Canada did not 
have recourse to any procedure under the DSU with respect to the EC implementing measure 
(Directive 2003/74/EC)   Under those circumstances, we deem it sufficient to limit our findings to 
Article 23 and exercise judicial economy with regard to the EC claim under Article 21.5 of the DSU.  
(e) Violation of Article 23.1 of the DSU 
7.243  Since we found that Canada has sought the re dress of a violation with respect to the EC 
implementing measure (Directive 2003/74/EC) and made  a determination without having "recourse to 
dispute settlement in accordance with the rules and procedures of [the DSU]" within the meaning of 
Article 23.2(a), we conclude that  Canada failed to "have recourse to, and abide by, the rules and 
procedures of [the DSU]", in breach of Article 23.1 of the DSU. 
3. Conclusion 
7.244  On the basis of the above, the Panel conclud es that Canada has violated Article 23.1 and 
23.2(a) of the DSU by seeking redress of a violati on of the WTO Agreement through a determination 
that the EC implementing measure did not comply with the DSB recommendations and rulings in the 
                                                      
444 Emphasis added. 
445 Comparatively, there wa s no need for the negotiators of the DSU to refer to compliance with the 
results of consultations, mediation, conciliation or good offices since the results of such means of dispute 
resolution have, by their very nature, to be accepted by the parties.  WT/DS321/R 
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  EC – Hormones  case without having recourse to dispute settlement in accordance with the rules and 
procedures of the DSU. 
C. SECOND SERIES OF EC CLAIMS : VIOLATION OF ARTICLE  23.1,  READ TOGETHER WITH 
ARTICLES  22.8  AND 3.7 OF THE DSU 
1. Summary of the main arguments of the parties446 
7.245  The European Communities  argues that Canada is violating its obligations under 
Article 23.1, read in conjunction with Articles 22. 8 and 3.7 of the DSU, by continuing to suspend 
concessions and related obligations  even though the European Communities has taken and notified to 
the DSB the measures to implement its obligati ons and these measures have not been found WTO-
inconsistent in an Article 21.5 procedure. 
7.246  The European Communities adds that, in order to demonstrate that Canada is in violation of 
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU, it is not required to explain in full 
the substance of its compliance measure and why this measure implements the DSB recommendations 
and rulings.  Rather, the European Communities re lies on the presumption of good faith which cannot 
be undermined by a unilateral and unsub stantiated determination by Canada.  
7.247  The European Communities considers that, under Article 23.1 of the DSU, Canada is obliged 
to have recourse to, and abide by, the rules and procedures of the DSU which encompass, inter alia , 
Articles 22.8 and 3.7 of the DSU. According to these provisions, Canada is obl iged not to apply any 
longer the suspension of concessions and related oblig ations after the inconsistent measure has been 
removed by the European Communities. 
7.248  According to the European Communities, the au thorization to suspend concessions or other 
obligations is a last resort, temporary measure a nd one of its main objectives is to induce compliance 
by the violating WTO Member.  This objective en tails, however, that once a Member has adopted 
compliance measures which are not properly challe nged by the complaining Member, the suspension 
of concessions or other obligations can no longer be a pplied. Indeed, in such a scenario the suspension 
of concessions or other obligations would be deprived  of one of its main objectives, i.e. to achieve 
implementation of a DSB decision, for the simple  reason that the WTO Member has already taken 
measures to implement the DSB recommendation.  
7.249  The European Communities acknow ledges that Article 22.8 of the DSU does not specify how 
the removal of the WTO inconsistency is determined .  However, in the light of its context, i.e. 
Articles 21.5 and 23.2(a) of the DSU, and given the exceptional nature of countermeasures, it is clear 
that a Member cannot unilaterally determine that  the WTO inconsistency persists despite the 
notification of a compliance measure.  Likewise, a Member cannot decide to continue to suspend concessions or other obligations unilaterally. 
7.250  According to the European Communities, th e WTO inconsistency of the implementing 
measure can only be determined in accordance with the appropriate procedure, namely Article 21.5 of 
the DSU.
447 Unless such a procedure concludes that th e compliance measure does not fully implement 
the DSB recommendations and rulings, it cannot be presume d that this is the case .  This also follows 
from the general principle of good faith as it applie s in international State relations, under which 
States are normally considered to act in conformity  with their obligations. This principle has been 
                                                      
446 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
447 EC's first written submission, para. 84. WT/DS321/R 
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  recurrently recognized in WTO jurisprudence.  This  principle constitutes one of the cornerstones of 
the WTO dispute settlement system. Thus, unless it is proven in accordance with the rules and 
procedures under the DSU that a WTO Member viol ates its commitments, this Member has to be 
considered to act in conformity with its WTO ob ligations. The presumption of good faith also applies 
for implementing measures.  In application of this principle, Canada could not unilaterally determine 
that the European Communities implemented the DSB recommendations and rulings in a WTO 
inconsistent way. To the contrary, the European  Communities must be presumed to have complied 
with its WTO obligations, if Canada  refuses to establish the contrary. 
7.251  According to the European Communities, whet her a Member suspends for the first time 
concessions or other obligations or wishes to main tain the suspension despite an implementation act 
does not make a difference. In both cases, a Member must not substitute unilaterally its assessment of a WTO inconsistency of an implementation measure to the procedures under the DSU. 
7.252  In the view of the European Communities, th ese fundamental principles are not altered by the 
fact that there exists a DSB authorization under Article 22.7 of the DSU to suspend concessions or 
other obligations. The DSB authorization cannot change the fundamental rules under the DSU. Rather, the DSB implements these rules. Thus , as the DSU provides that the suspension of 
concessions or other obligations should not be applied unless a WTO violation by a Member's 
measure has been properly established, the DSB author ization cannot be interpreted to justify such a 
suspension if a WTO violation of a Member's (n ew) measures has not been properly determined. 
7.253  According to the European Communities, the basis for a DSB authorization to suspend 
concessions or other obligations is a prior multilateral  determination that the implementing WTO 
Member has failed to comply with  its obligations. This is the case if an Article 21.5 proceeding 
concludes that the implementing measure was insu fficient. This is also implicitly the case if a 
Member has not adopted any implementing measure at all at the time of the DSB decision under 
Article 22.7 of the DSU.  
7.254  Conversely, the European Communities argues, if a WTO Member implements properly its 
obligations after the DSB has aut horized the suspension of concessions  or other obligations the basis 
for this decision changes fundamentally. As the orig inal DSB authorization was taken in view of the 
original measure, it cannot logically encompass the new implementing measure. Hence, the DSB 
authorization cannot cover the continued applicat ion of the suspension of concessions or other 
obligations, if a WTO Member subsequently impl ements its obligations in the absence of a 
multilateral review regarding the compliance (or not) of this new measure.   
7.255  The European Communities adds that Canada's violation of Article 23.1 and Article 22.8 of 
the DSU necessarily entails a violation of Article 3.7 of the DSU.  As Article 3.7 of the DSU contains 
the basic principles for the applica tion of the suspension of concessions  or other obligations, it follows 
that once a Member violates Article 23.1 read in conjunction with Article 22.8 of the DSU it necessarily also acts contrary to Article 3.7 of the DSU.
448 
7.256  Canada argues that the failure of the European Co mmunities to comply within the reasonable 
period of time it had been granted gave Canada the right to seek authorization from the DSB to 
suspend concessions and subsequently to suspend concessions once that authorization was granted. 
However, the European Communities remains subject  to an ongoing obligation to comply with its 
WTO obligations, including those requiring it to comply promptly with the recommendations and rulings of the DSB. 
                                                     
 
448 EC's first written submission, paras. 67-123.  WT/DS321/R 
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  7.257  Canada considers that its measure, taken on the basis of this authorization by the DSB, is by 
definition WTO-consistent. As Canada's measure is  authorized by the DSB, and remains under the 
surveillance of the DSB, it is the DSB that must also determine whether the conditions exist for the 
termination of that authorization.  Any mechanism for terminating the authorization that is not under 
the authority and surveillance of the DSB undermines the ability of the dispute settlement system to 
achieve one of its central objectives, that of ensuri ng the security and predictability of the multilateral 
trading system. 
7.258  Canada argues that, on the basis of the fo regoing, the Panel must find that the DSB 
authorization permitting Canada to suspend con cessions to the European Communities remains in 
effect and, as a result, that Canada's measure is  not inconsistent with its obligations under any 
provision of the DSU. 
7.259  According to Canada, as it is the European Communities that now seeks to have Canada's 
authorized measure "de-authorized", it is the EC that bears the burden of demonstrating to the DSB 
that the measure should no longer be authorized, by virtue of some action it has taken to comply. This 
is a necessary conclusion that flows from the gene ral rule concerning the burden of proof, which 
states that the party asserting a particular claim has the burden of proving it.449  
7.260  Canada notes that the European Communities ma y have had recourse to proceedings initiated 
under Article 21.5; there is nothing inherent in the wording of Article 21.5 that would prevent 
recourse to it by a Member that wishes to confirm the actual compliance of its measure and have the DSB authorization terminated by the DSB. Alte rnatively, the European Communities may initiate 
new proceedings in which it requests the Panel to determine the actual compliance of a measure it has 
adopted to implement the recommenda tions and rulings of the DSB.  If the European Communities is 
successful in persuading the Panel that is has ind eed complied, the result would be a recommendation 
to the DSB to terminate the DSB authorization.  In  either scenario, and in the absence of a mutually 
satisfactory solution, the continued suspension of  concessions by Canada remains authorized and 
WTO-consistent until the European Commun ities initiates WTO proceedings, successfully 
demonstrates the actual compliance of its own me asure, and has the DSB terminate the original 
authorization. 
7.261  Canada is of the view that the EC allegations of violation of Articles 22.8 and 3.7 of the DSU 
by Canada not only ignore the ongoing existence of the DSB authorization and the European 
Communities own responsibilities, they are also base d on an unsupportable assertion that the current 
EC measure benefits from a presumption of compliance. 
7.262  Canada does not disagree with the European Communities on the temporary nature of the 
suspension of concessions. Canada accepts that, in th e absence of a mutually satisfactory solution, it 
may only maintain its suspension of concessions un til such time as it receives confirmation from the 
DSB that its efforts at inducing compliance have b een successful, that the EC has in fact implemented 
the recommendations and rulings of the DSB in EC – Hormones  and that, as a result, the DSB 
authorization has been terminated.  Canada re jects, however, the EC assertion that somehow the 
period provided for in Article 22.8 has passed in  these circumstances and th at the suspension of 
concessions previously authorized by the DSB must now be ended. 
7.263  Canada disagrees with the EC contention that its measure should benefit from a presumption 
of compliance in these particular circumstances. Th is dispute does not concern an EC measure taken 
as part of its regular day-to-day business of govern ing, prior to the engagement of the WTO dispute 
settlement mechanism. Nor does it co ncern a measure that the EC h as taken to comply within the 
reasonable period of time, and prior to the adop tion of DSB authorization to suspend concessions. 
                                                     
 
449 Appellate Body Report on US – Wool Shirts and Blouses , DSR 1997:I, p. 323 at 333-338. WT/DS321/R 
Page 184 
 
 
  Any measure taken by the European Communities in  either of these scenarios would be presumed to 
comply with its international obligations unless otherw ise challenged.  Rather, the dispute before this 
Panel concerns the failure of the European Comm unities to correct, within the reasonable period of 
time, a measure that had been found by the DSB to be inconsistent with the WTO obligations of the 
European Communities, and as a result the DSB authorized Canada to suspend concessions. 
7.264  According to Canada, the European Communities' at tempt to have its measure treated as if it 
had been adopted within the reasonable period of  time, and prior to the adoption of the DSB 
authorization, ignores the legal reality of the current circumstances.  Contrary to the EC's claims, there 
is very good reason to assume that the legal situation is not identical to that which prevailed prior to 
the adoption of the DSB authorization. The existence of the authorization by the DSB of Canada's measure distinguishes this case from those situations  in which a general presumption of compliance 
would apply to the EC measure. 
7.265  In Canada's opinion, the DSU does not exp licitly address how a DSB authorization of 
suspension of concessions, once granted, is to be terminated. The European Communities itself 
acknowledges this point, but not its implications. In the absence of a specific provision setting out a mechanism, the DSU must be interpreted in such a way that each of its provisi ons can be given effect 
that is consistent with the object and purpose of the DSU. 
7.266  Canada notes, on the one hand, a measure taken by the European Communities to comply 
would benefit from a presumption of compliance prior to the adoption by the DS B of an authorization 
to suspend concessions. On the other hand, a measur e taken by Canada to suspend concessions on the 
basis of that authorization is in actual complia nce with its WTO obligations. The adoption by the 
European Communities of a measure that it consid ers to implement its WTO obligations cannot, in 
itself, revoke the DSB authorization; in the absence of  revocation by the DSB, that authorization still 
stands. As a result, any presumed compliance that the EC's measure would enjoy prior to the adoption 
of the DSB authorization must yield to the act ual compliance of Canada's measure suspending 
concessions. 
7.267  According to Canada, accepting any other interpre tation of the relevant provisions of the DSU 
would undermine the objective of the dispute settle ment system to ensure the security and 
predictability of the multilateral trading system. 
7.268  As far as the EC allegation of violation of Artic le 3.7 is concerned, Canada argues that since 
Canada has demonstrated that it has not acted incons istently with Article 22.8, the EC claims related 
to Article 3.7 must also fail.
450 
7.269  The European Communities  does not deny that the DSB authorization has not formally been 
withdrawn. However, under Article 22.8 of the DSU it does not matter whether the DSB authorization 
has formally been removed or not. Rather, what ma tters is whether the suspension of concessions and 
related obligations may still be "applied" (pursuant to a DSB authorization). Article 22.8 of the DSU  
unequivocally provides that the suspension of co ncessions and related obl igations may only be 
"applied" until the inconsistency of  the measure has been removed.  
7.270  According to the European Communities, Canada  completely ignores this difference between 
the "existence" of a DSB authorization and the "a pplication" of the suspension of concessions and 
related obligations (pursuant to that DSB authori zation). Canada presents the European Communities' 
case to mean that the DSB authorization would be "withdrawn", "revoked" or "terminated". Yet, for 
the purpose of Article 22.8 of the DSU, the status of the DSB authorization does not matter. 
                                                      
450 Canada's first written submission, paras. 37-65.  WT/DS321/R 
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  7.271  Furthermore, the European Communities emphasi zes the self-executing nature of Article 22.8 
of the DSU. The termination of the application of sanctions under this provision does not depend on a 
specific finding of the DSB or a withdrawal of th e DSB authorization. Rather, once the conditions 
under Article 22.8 of the DSU are met – including in the presence of an unchallenged compliance measure – the application of suspension "shall" stop. 
7.272  The European Communities argues that Canada's  theory regarding the reversed burden of 
proof is rooted in the misconception that otherw ise the DSB authorization would be terminated 
merely on the basis of a presumption of good faith compliance. As already mentioned, the question 
under what conditions the DSB authorization may be terminated is not the issue in this dispute. 
7.273  The European Communities notes th at Canada's theory has no basis either under WTO law or 
under public international law.  The WTO jurisprude nce is clear that the party bearing the burden of 
proof is the one that asserts the affirmative of a claim or defence. Furthermore, the burden of proof is 
one concrete example of the gene ral good faith principle, i.e. the presumption of compliance. This 
principle applies to an implementing measure as su ch but not to a specific timing when the measure 
had been adopted.  
7.274  According to the European Communities, Canada 's argument about security and predictability 
could be understood to mean that the only secu re and predictable way under the DSU is the 
application of sanctions as such. However, the ap plication of sanctions under the DSU is not an 
objective in itself. The application of sanctions is designed to achieve another, higher objective, i.e. 
full compliance with the WTO obligations by anot her Member. Thus, if a violating Member has 
adopted compliance measures in good faith, it is indeed  a matter of security and predictability of the 
trading system that the application of sanctions ceases to apply, if these measures are never properly 
challenged. If an implementing Memb er could not have the expectation that the sanctions would end 
the security and predictability of the WTO Agreemen t were indeed put at risk because this might 
reduce the incentive for an implementing Member to comply.  
7.275  Finally, the European Communities would addr ess Canada's theory regarding the way a DSB 
authorization may be terminated. The DSU do es not provide for any procedure on how a DSB 
authorization could be formally terminated, and the idea of an implicit revocation is baseless.  What 
the DSU, however, provides is until when the suspension of concessions may be "applied".
451 
7.276  Canada  argues that in circumstances where concessi ons have been suspended on the basis of 
an authorization by the DSB, and where no mutually  satisfactory solution has been reached, the onus 
is on the Member originally found to be non-complian t to take steps to confirm multilaterally that it 
has satisfied at least one of the conditions of Ar ticle 22.8 if it wishes to have the suspension of 
concessions no longer applied. Without such multilate ral confirmation, the DSB authorization remains 
in effect and continues to aut horize the suspension of concessions  by the original complaining 
Member. This right to continue to suspend con cessions is unaffected by any views the original 
complaining Member may develop and express regarding the actual compliance of the other 
Member's implementing measure. 
7.277  Canada considers that the 2003 Directive simply am ends the 1996 Directive.  It is also clear 
that the EC attempt to comply is after the reasona ble period of time that it was granted to do so. The 
European Communities cannot escape th e consequences that its status of non-compliance, or late 
compliance as the case may be, in the previous disput e has on its rights and obligations at issue in this 
dispute. 
                                                      
451 EC's second written submission, paras. 42-63. WT/DS321/R 
Page 186 
 
 
  7.278  Canada argues that it has not transferred the a pplication of the authorization from the "old" 
inconsistent measure to a "new" unc onfirmed measure. It is simply th at Canada neither agrees nor has 
received multilateral confirmation that the Europ ean Communities has brought itself into compliance. 
In the absence of either of these circumstances being met, Canada is entitled to continue to rely upon 
the authorization. 
7.279  According to Canada, the question is not when , whether and how the DSB authorization is 
terminated, revoked or ceases to have effect, but ra ther which party bears the burden of confirming 
the compliance of the implementing measure.  The requirement that the European Communities bear 
this burden if it wishes to have the suspension of concessions ended is simply the logical consequence 
of the position in which it has placed itself in the EC – Hormones dispute. 
7.280  Canada is of the view that Article 22.8 of th e DSU cannot be "self-executing" in the light of 
the overall regime of surveillance established by th e DSU in circumstances of non-compliance.  In the 
light of the object and purpose of the DSU, and in the context of the other provisions relating to non-
compliance, Article 22.8 requires multilateral confir mation that the conditions precedent have been 
satisfied before the suspension of concessions can no longer be applied. Most importantly, the 
authorization to suspend concessions as a result of a failure to comply within the reasonable period of 
time is granted solely by the DSB.  The legal consequence of the combination of the ongoing DSB 
surveillance of non-compliance, the multilateral nature  of the authorization and the reliance on that 
authorization by the original complaining Member is  that a subsequent, unconfirmed claim that one of 
the conditions of Article 22.8 has been met is in sufficient on its own to displace the multilaterally-
agreed surveillance regime, regardless of how much  effort is put into the measure underlying the 
claim.  
7.281  According to Canada, in arguing that it has complied in good faith, the European 
Communities confuses several distinct issues relate d to "good faith" and "bad faith". The linkage 
made by the European Communities between the two should be rejected .  The issue before this Panel 
is not whether the European Communities acted in "b ad faith" when it adopted the 2003 Directive. It 
is, in the first instance, whether the 2003 Directive should be presumed to bring the EC 1996 Directive into compliance, and if such a presumption should not apply, whether the 2003 Directive 
actually does bring the EC 1996 Directive into comp liance. As the Appellate Body has made clear, a 
finding that a Member does not comply with its WTO obligations – not to mention a mere investigation into whether or not it does – amount s to neither an accusation nor a finding of "bad 
faith".  Similarly, an interpretation of the DSU that would deny the European Communities a 
presumption of compliance cannot be equated to a findi ng that it is presumed to have acted, or that it 
did act, in bad faith.  The European Communities can  make bona fide efforts to comply with its 
obligations and still not in the end succeed in complying.  The principal issue in a review of the EC 
claim of compliance is not whether the European Communities should be presumed to have acted in 
good faith, but rather it is whether the Europ ean Communities has actuall y complied. In these 
circumstances, since Article 22.8 cannot be self-e xecuting, the European Communities cannot benefit 
from a presumption of compliance and must instead demonstrate this compliance. 
7.282  Canada adds that, ultimately the Panel should co nsider whether the adoption of a measure in 
one Member can be allowed to automatically render  WTO-inconsistent a measu re of another Member, 
without some intervening international act.  The si mple answer is no. Any other interpretation of 
Article 22.8 would allow a unilateral act to suppl ant a multilateral act, an outcome clearly not 
provided for in the DSU. 
7.283  
Canada considers that the European Co mmunities places considerable emphasis on the 
distinction between the "termination/revocation" of the authorization, on the one hand, and the fact that the suspension of concessions may "no longer be  applied", on the other. By focusing on such  WT/DS321/R 
 Page 187 
 
 
  formalities related to the termination of the author ization, the European Communities is attempting to 
distract the Panel from the EC substantive obligations arising out of the EC – Hormones  dispute. 
7.284  Canada notes that while no specific provision in the DSU requires the formal revocation of 
the DSB authorization, that does not mean that there cannot be, or should not be, an act by the DSB that is equivalent to revoking the authorization,  whether that is implicit or explicit. Since the 
"multilateral confirmation" of compliance required before Article 22.8 can be given effect would 
generally come in the form of adoption by the DS B of panel findings of compliance, "confirmation" 
of compliance and the "revocation" of the authori zation are essentially the same act of the DSB.  The 
"revocation/termination" of the DSB authorization can therefore be either implicit or explicit. It would 
be implicit if the DSB simply adopted a panel's findings of compliance without addressing the issue of the status of the authorization. It would be explic it if the DSB specifically noted that as a result of its 
confirmation of compliance, its previous  authorization no longer was in effect. 
7.285  According to Canada, it is the EC's preroga tive to choose to confirm its compliance in 
proceedings de novo, such as in these proceedings, in  order to have the DSB authorization removed. 
The key issue in such proceedings  is that the European Communiti es  bears the initial burden of 
demonstrating that it has indeed brought itself in to compliance for the Panel to find that the DSB 
authorization should cease to have effect. Now th at the European Communities appears to have 
accepted that burden here, the main objective of these proceedings should be a review of the 
compliance of the EC measure with the reco mmendations and rulings of the DSB in EC – 
Hormones.
452 
2. Approach of the Panel 
(a) Duty of the Panel to make an objective assessment of the matter before it 
7.286  In light of the EC statement that this case is  about procedural viol ations under the DSU453, and 
in view of our findings above, we could normally exercise judicial economy and complete our review 
of this case at this juncture.  Indeed, we found that Canada committed a procedural error under the 
DSU, breached Article 23.1 and 23.2(a) and shoul d have had recourse to dispute settlement in 
accordance with the rules and procedures of the DSU if  it wanted to seek redress of a violation of the 
WTO Agreement through a determination of viol ation of the WTO Agreement with respect to 
Directive 2003/74/EC. 
7.287  However, the European Communities claims a separate violation of Article 23.1, read 
together with Article 22.8 and Article 3.7 of the DSU.  Under those claims, the European 
Communities alleges inter alia  that Canada breached Article 22.8 because it failed to withdraw its 
suspension of concessions even though the Europ ean Communities removed the measure found to be 
inconsistent with a covered agre ement.  We also note Canada's argument that it did not breach 
Article 22.8 of the DSU because the EC implementing measure does not comply  with the 
SPS Agreement . 
7.288  We recall that we considered that the two series of main EC claims were such that they could 
be addressed independently from each other.454 Our findings of violation of Article 23.1 and 23.2(a) 
under the first series of main EC claims are co mpletely unrelated to whether the European 
Communities implemented the DSB re commendations and rulings in the EC – Hormones  dispute in 
substance.  Indeed, our findings are based on the fail ure of Canada to have recourse to the procedures 
under the DSU as a result of the notification of Directive 2003/74/EC – a purely procedural step.  In 
                                                      
452 Canada's second written submission, paras. 18-44. 
453 EC's first written submission, para. 22. 
454 See paras. 7.162-7.164 above. WT/DS321/R 
Page 188 
 
 
  contrast, we note that the second series of main EC  claims – and the altern ative claim of "direct" 
violation of Article 22.8 of the DSU for that matter – are not premised on the mere existence of an EC 
implementing measure, but on its conformity  (presumed or actual) with the SPS Agreement . 
7.289  Under those circumstances, one cannot exclude that no violation of Article 23.1 of the DSU 
may be found under the second series of main EC cl aims even though a violation of Article 23.1 was 
found under the first series of main EC claims, if only because they are based on different premises.    
7.290  We recall in this regard that Article 11 of  the DSU instructs us to assist the DSB in 
discharging its responsibilities and provides that, acco rdingly, a panel should make an objective 
assessment of the matter before it. In this case,  the matter raised by the European Communities 
contains two separate elements: a series of claims  related to the procedural obligations of the 
responding party and a series of claims premised on the violation by the responding party of Article 22.8 of the DSU due to compliance by th e European Communities with its obligations under 
the WTO Agreement. We should therefore address both series of claims.   
7.291  In addition, we also note that, since our repor t may be appealed and the Appellate Body can 
only rule on issues of law, we must provide suffici ent factual basis to allow the Appellate Body to 
complete the analysis, if necessary.
455  In that context, in order to  ensure in all instances a positive 
resolution of this dispute, we consider that pr oceeding with a review of the second series of main 
claims raised by the European Communities is appropriate. 
7.292  Before proceeding with the review of this second series of claims, we want to stress that in 
reviewing the EC claims of violation of Article 23.1 read together with Article 22.8 and Article 3.7 of 
the DSU, our intention is not to substitute ourselv es for a compliance panel under Article 21.5 of the 
DSU.  We will make findings with respect to the second series of main claims of the European Communities with the only purpose to reach a conclusi on on the violation of the provisions referred to 
in those claims. 
(b) Order of review of the second series of ma in claims by the European Communities 
7.293  We recall that the second series of EC claims is that Canada breaches Article 23.1, read 
together with Articles 22.8 and 3.7 of the DSU.  We also note that the European Communities argues 
more particularly that Article 22.8 prohibits the c ontinued unilateral application of the suspension of 
concessions or other obligations when the measure wh ich has been found incons istent is removed.  
We conclude from this that the EC claim under Article 23.1 is conditioned by the EC claim under 
Article 22.8 or, more precisely, that the findings th at the European Communitie s wants us to make in 
relation to Article 23.1 are dependent on the findin gs that the European Communities wants us to 
make under Article 22.8.  In other words, the second series of claims of the European Communities is 
premised on a violation by Canada of  its obligations under Article 22.8. 
7.294  We therefore conclude that we should begin our analysis of the second series of main claims 
of the European Communities with a review of the compatibility of Canada's measure at issue with 
Article 22.8 of the DSU. We consider that:  
(a) if we find a breach of Article 22.8 of th e DSU, we will proceed with reviewing the 
EC claims of violation of Articles 23.1 and 3.7 of the DSU, read together with 
Article 22.8; 
                                                     
 
455 See, e.g., Appellate Body Reports on Canada – Periodicals , DSR 1997:I, p. 449 at 469; Australia – 
Salmon , para. 118;  and Korea – Dairy , para. 92.  WT/DS321/R 
 Page 189 
 
 
  (b) if we find no violation of Article 22.8, th ere will be no need for us to proceed any 
further with the review of these second series of claims by the European 
Communities.  
7.295  We now proceed with our review of the EC claim under Article 22.8 of the DSU. 
3. Violation of Article 22.8 of the DSU 
(a) Preliminary remarks 
7.296  Article 22.8 reads as follows: 
"The suspension of concessions or other ob ligations shall be temporary and shall only 
be applied until such time as the measure f ound to be inconsiste nt with a covered 
agreement has been removed, or the Member that must implement recommendations 
or rulings provides a solution to the nullifi cation or impairment of benefits, or a 
mutually satisfactory solution is reached.  In accordance with paragraph 6 of Article 21, the DSB shall continue to k eep under surveillance the implementation of 
adopted recommendations or rulings, incl uding those cases where compensation has 
been provided or concessions or other ob ligations have been suspended but the 
recommendations to bring a measure into conformity with the covered agreements 
have not been implemented." 
7.297  In light of terms of Article 22.8 and the argum ents of the parties, we believe that two 
preliminary questions have to be addressed with  respect to the violation of Article 22.8: 
(a) one is when the suspension of concessions should cease to be applied; 
(b) another one is what is meant by "the measu re found to be inconsistent with a covered 
agreement". 
7.298  Regarding the first question, we recall that the terms of Article 22.8 make it clear that 
countermeasures may remain in place only until such time as the measure found to be inconsistent by 
the DSB is removed.  In other words, the removal of the illegal measure by the losing party must lead, 
without delay, to the removal of the suspension of obligations by the Member authorized by the DSB 
to suspend concessions. 
7.299  Regarding what is meant by "the measure found to  be inconsistent with  a covered agreement", 
one interpretation could be to consider that th e measure found to be inconsistent was Directive 
96/22/EC.
456  This measure was removed.  However, su ch an interpretation is unsatisfactory, as 
Directive 96/22/EC was replaced by Directive 2003/74/ EC which also imposes an import ban.  The 
Panel notes that the European Co mmunities agrees 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 measure, has been removed.457 
7.300  The Panel believes that the term "measure" s hould not be interpreted narrowly as applying 
only to the legislation at issue.  What Canada challenged as a complainant in the EC – Hormones  case 
was an import restriction on meat and products from cattle treated with growth  promoting hormones.  
We consider that this interpretation is confirme d by the second sentence of Article 22.8 which refers 
                                                      
456 Official Journal of the European Communities, No. L 125, 23 May 1996, p. 3. 
457 See EC's first written submission, para. 79, EC's replies to Panel questions after the first substantive 
meeting, question 55, Annex B-1.   WT/DS321/R 
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  to the DSB keeping under surveillance situations where obligations have been suspended "but the 
recommendations to bring a measure into conformity  with the covered agreements have not been 
implemented".  We read this phrase as implying that wh at is to be achieved is not the removal of the 
measure but the actual compliance with the recommendations or rulings of the DSB. 
7.301  We therefore conclude that Article 22.8 may be breached only if the European Communities 
has complied with the recommendations and rulings of  the DSB and Canada has failed to immediately 
remove its suspension of concessions or other obligations. 
7.302  We recall that the European Comm unities considers that this case is not about its compliance  
with the recommendations and rulings of the DSB in the EC – Hormones  case. We nonetheless note 
that the European Communities requests us to make findings in relation to Article 22.8 under its main 
claim and that it did not exclude the possibility fo r the Panel to review the substance of the EC 
implementation measure in the context of its conditional allegation of "direct" violation of 
Article 22.8.  We note, however, that such claim wa s made "in the alternative", i.e. if the Panel found 
no violation of the DSU under the other EC claims. In  the context of its second series of main claims, 
the European Communities alleges th at it does not have to demonstrate that it has complied with the 
recommendations and rulings of the DSB since it should benefit from a presumption of good faith 
compliance with respect to Directive 2003/74/EC.  We note that Canada argues that the European 
Communities has not removed the measure found to be inconsistent with a cove red agreement.  More 
particularly, Canada argues that the EC implementing measure breaches the SPS Agreement . 
7.303  Having regard to the arguments of the parties regarding the conformity of the EC 
implementing measure with the SPS Agreement , the Panel believes that it must determine the scope of 
its jurisdiction in this respect. 
(b) Jurisdiction of the Panel  
(i) Introduction 
7.304  This case is not the first one about complian ce of a Member with its obligations under the 
DSU and, in particular, under Article 23.458 However, because of the clai m raised by the European 
Communities under Article 22.8 of the DSU, the argume nts of Canada and the links between this case 
and the EC – Hormones  case – in particular through the question of the compliance of the EC 
implementing measure with the SPS Agreement  – the second series of main  claims by the European 
Communities raises a number of questions which, to  our knowledge, were ne ver directly addressed 
before by a panel established under Article 6 of the DSU. 
7.305  In support of its claim under Article 23.1 read to gether with Article 22.8 and Article 3.7 of the 
DSU, the European Communities alleges in substan ce that it does not have to demonstrate that its 
implementing measure is compatible with the SPS Agreement .  Rather, the European Communities 
argues that it should be presumed to have removed in good faith the measure found inconsistent with 
the SPS Agreement  in the EC – Hormones  dispute and that this presumption could only be rebutted 
through a recourse to Article 21.5 of the DSU by the responding party.  
7.306  Canada disagrees that the European Communities benefit from any presumption of 
compliance and argues, on the contrary, that the European Communities failed to demonstrate that it 
has complied with the SPS Agreement .  
                                                      
458 In US – Section 301 Trade Act , Article 23.2(a) and (c) of the DSU were at issue, in US – Certain EC 
Products , Articles 23.1 and 23.2(c) as well as 23.2(a) of the DSU were addressed by the panel and the Appellate 
Body.  WT/DS321/R 
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  7.307  Therefore, before we proceed any further, we believe that we should answer the two 
following questions: 
(a) In light of the EC claim that it benefits from a presumption of good faith compliance, 
do we need to determine whethe r the EC implementing measure actually  complies 
with the SPS Agreement  in order to address the EC claim of violation of Article 23.1 
read together with Article 22.8 and Article 3.7 of the DSU?  
(b) if yes, do we have the jurisdiction to address the conformity of the EC implementing 
measure with the SPS Agreement ? 
(ii) Does the Panel need to determ ine whether the EC implementi ng measure actually complies 
with the SPS Agreement in order to address the EC claim of violation of Article 23.1 read 
together with Article 22.8 and Article 3.7 of the DSU? 
Introductory remarks  
7.308  Having regard to the arguments of the parties, the Panel considers that it needs to determine: 
(a) whether the European Communities can invoke a presumption of good faith 
compliance; and, if yes, 
(b) whether, and how, such a presumption could be rebutted. 
7.309  The Panel notes that, generally, when good faith is  referred to in a dispute, this is in relation 
to the measure adopted by the defending party459, not with respect to a measure adopted by the 
complaining party – in this case the European Comm unities.  Normally, a complainant does not have 
to show that it applies a measure in good faith, sin ce this is normally not the measure at issue in the 
dispute.  However, the demonstration by the Euro pean Communities of a violation of Article 22.8 by 
Canada in this case implies that it prove that it h as removed the measure found to be inconsistent with 
a covered agreement in the EC – Hormones  case. The Panel also recalls that it found above that 
Canada should have had recourse to the DSU in rela tion to the EC implementing measure.  If Canada 
had had recourse to the dispute settlement pro cedures under the DSU – including the procedure 
provided in Article 21.5 – the European Communiti es would have been the defending party and its 
implementing measure would have benefited from a presumption of compatibility with WTO rules.460  
For these reasons, the Panel deems it appropriate not  to take position on wh ether good faith can be 
invoked only by the defendant.  Instead, it will address the issue by disregarding the status of the European Communities as complaining party in this case.   
Applicability of the principle of good faith in the WTO and under the DSU
 
Introduction 
7.310  We note that what the European Communities clai ms in this respect is the existence of a 
presumption of good faith compliance based on the inte rnational law principle of good faith.  We note 
I n this regard that Article 31.3(c) of the Vie nna Convention on the Law of Treaties (1969) provides 
that: 
                                                      
459 See, e.g., Appellate Body Report on US – Carbon Steel , para. 157. 
460 See, e.g., Appellate Body Report on Canada – Dairy (Article 21.5 – New Zealand and US II) , 
para. 66. WT/DS321/R 
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  "[t]here shall be taken into account, together  with the context: ... (c) any relevant rule 
of international law applicable to the relations between the parties." 
7.311  Having regard to the overarching nature of the principle of good faith in international legal 
relations, we deem it appropriate to  determine first whether there is any basis in public international 
law for the principle to which th e European Communities refers.  If this is the case, we will then 
proceed with determining whether the WTO Agreemen t in general and the DSU in particular exclude 
the application of this principle. 
General international law 
7.312  We note that what the European Communities refers to in its submissions is a presumption 
that it acted in good faith and thus must be presu med to have complied with the recommendations and 
rulings of the DSB. 
7.313  We are of the view that the principle of good faith  could be analysed mainly in respect of the 
following categories: 
(a) good faith conduct in a dispute settlement procedure; 
(b) substantive good faith, i.e. with respect to the substantive obligations of a State; 
(c) good faith in the interpretation process (Ar ticle 31 of the Vienna Convention on the 
Law of Treaties). 
7.314  What the European Communities invokes in this  case seems to fall primarily within the 
category of substantive good faith.  
7.315  This allegation of the European Communities rai ses, in our opinion, two related but distinct 
issues under general international law: 
(a) the first one is whether a presumption that States act in good faith exists under 
general international law; 
(b) the second one is whether such presumption of good faith can be assimilated to a 
presumption of compliance. 
7.316  Good faith is one of the basic principles re garding the creation and execution of legal 
obligations in public  international law.461  This principle is expressed inter alia  in Article 26 of the 
Vienna Convention on the Law of Treaties: 
"Every treaty in force is binding upon the pa rties to it and must be performed by them 
in good faith." 
7.317  It is implicit from the duty to perform treaty  obligations in good faith that a party to an 
international agreement should be d eemed to have acted in good faith in the performance of its treaty 
obligations. More generally, even  though Article 26 provides for an obligation and not a presumption, 
pacta sunt servanda  is but only one expression of the principl e of good faith.  Good faith is a general 
principle of international law that governs all reciprocal actions of States.462  We are therefore inclined 
                                                      
461 See, e.g., ICJ, Nuclear Tests Case , Judgement of 20 December 1974, ICJ Reports 1974, p. 473, 
para. 49. 
462 See also UN Charter, Article 2.2;  ICJ, Corfu Channel  Case , Judgement of 9 April 1949, dissenting 
opinion by Judge ad hoc B. E čer, ICJ Reports 1949, p. 119; Malcom N. Shaw: International Law (5th edition),  WT/DS321/R 
 Page 193 
 
 
  to agree with the European Communities that ever y party to an international agreement must be 
presumed to be performing its obligation under that agreement in good faith. 
7.318  Having concluded that, under general interna tional law, States enjoy a presumption of good 
faith, we now proceed to determine whether pr esumption of good faith can be equated with 
presumption of compliance with treaty obligations. 
7.319  The Panel notes in this respect that good faith has been defined as a: 
"disposition d'esprit de loyauté et d'honnêteté consistant en ce qu'un sujet de droit ne 
tente pas de minorer ses obligations, quels qu'en soit l'origine et le fondement ..."463  
7.320  According to this definition, a State acting in  good faith should be honestly seeking to comply 
with its obligations.  A presumption of good fait h could thus extend to compliance. It is the 
understanding of the Panel that States benefit in th eir actions from the principle that a breach of the 
principle of good faith cannot be presumed and th at any State alleging an abuse of right ( abus de 
droit ) or, more particularly,  a breach of the principle of good faith, must prove it.464 
7.321  As a result, we note that, under general intern ational law, the European Communities would 
be entitled to claim a presumption of good faith compliance. 
7.322  However, that does not mean that the State invoking good faith compliance, while acting in 
total good faith, actually complied with its treaty oblig ations.  It could make an illegal interpretation 
of its obligations without breaching the principl e of good faith. Thus, if good faith compliance is 
presumed, it cannot be a non-rebuttable or juris et  de jure  presumption. 
7.323  An additional element to consider is that , under general public international law, every  State 
benefits from the application of the principle of goo d faith.  We therefore agree with Canada that if 
the European Communities can clai m good faith compliance, Canada t oo should also benefit from the 
same presumption.  Unlike in "nor mal" cases where only the measure adopted by one Member is at 
issue, in this case the legality of Canada's m easure challenged by the European Communities depends 
on whether the measure taken by the European Communities to comply with DSB recommendations and rulings is WTO consistent. In other words, bot h parties can invoke the presumption of good faith.  
However, we do not see the fact that both parties can  invoke good faith in relation to diametrically 
opposed positions as affecting the applicability of th is principle in this case.  Indeed, we are only 
dealing with presumptions, not with evidence.  As long as these presumptions can be rebutted before a 
panel, we see no inherent problem to the fact that both parties claim good faith.  
The text of the DSU 
7.324  The Panel first notes that, with the exception of Articles 3.10 and 4.3, there is no reference to 
good faith in the DSU.  Of those two references,  that in Article 4.3 relates specifically to 
                                                                                                                                                                    
 
p. 811-812: "[Pacta sunt servanda] underlies every international agreemen t for, in the absence of a certain 
minimum belief that States will perform their treaties oblig ations in good faith, there is no reasons for countries 
to enter into such obligations with each other."   
463 Jean Salmon: Dictionnaire de droit international public , p. 134.  Black Law Dictionary, 6th ed., 
para. 693: 
 
"In common usage the term is ordinarily used to describe that state of mind denoting honesty 
of purpose, freedom from intention to defraud and, generally speaking, means being faithful to 
one's duty or obligation." 
 
464 PCIJ, Upper Silesia Case , Judgement of 25 May 1926, Series A. No. 7, p. 30. WT/DS321/R 
Page 194 
 
 
  consultations.  Only that in Article 3, entitled "Gen eral Provisions", could have a relevance in this 
case.  However, Article 3.10 reads as follows: 
"It is understood that requests for concilia tion and the use of the dispute settlement 
procedures should not be intended or consid ered as contentious acts and that, if a 
dispute arises, all Members will engage in these procedures in good faith in an effort 
to resolve the dispute.  It is also unders tood that complaints and counter-complaints in 
regard to distinct matters should not be linked." 
7.325  The Panel understands the reference to good faith in Article 3.10 of the DSU to relate to the 
manner in which parties to a dispute should particip ate in the dispute (i.e. procedural good faith, as 
described above), not specifically to whether Member s should be presumed to be acting in good faith.  
Indeed, the reference to good faith is made in re lation to "engage[ing] in [DSU] procedures in good 
faith in an effort to resolve the dispute " (emphasis added) and the preceding phrase provides that DSU 
procedures "should not be intended or considered as contentious acts". 
7.326  The Panel therefore considers that Article 3.10 is of limited direct relevance to determine 
whether the European Communities should benef it from a presumption of good faith compliance 
under the DSU. 
7.327  However, the references to good faith in the DS U are evidence that the DSU does not exclude 
the application of the principle of good faith in the resolution of disputes.  The Panel is of the view 
that, since the application of the principle of good faith is not expressly excluded by the DSU, it is 
applicable to WTO Members.465 
The panel and Appellate Body practice 
Presumption and burden of proof 
7.328  The Panel notes that, in US – Wool Shirts and Blouses , the Appellate Body recalled that: 
"[W]e find it difficult, indeed, to see how an y system of judicial settlement could 
work if it incorporated the proposition th at the mere assertion of a claim might 
amount to proof."466 
7.329  However, the Appellate Body also mentioned in Japan – Apples  that: 
"[T]he Appellate Body statement in EC – Hormones  does not imply that the 
complaining party is responsible for providing proof of all facts raised in relation to 
the issue of determining whether a measure is consistent with a given provision of a 
covered agreement.  In other words, although the complaining party bears the burden 
                                                      
465 The Panel is not of the view that the fact  that some covered agreements, such as the SPS Agreement   
(see Article 2.4) expressly provide that measures of a Member which conform to a given agreement shall be 
presumed to be in accordance with the obligations of that Member under another covered agreement would 
imply that the presumption of good faith does not apply in the WTO Agreements unless expressly referred to.  The Panel considers that the reference to presumption in Article 2.4 of the SPS Agreement  is to a legal 
presumption and is intended to address potentially c onflicting interpretations between two provisions.  The 
reference in Article 3.2 of the SPS Agreement  can be explained by the fact that the "international standards, 
guidelines or recommendations" are not part of the WTO Agreement. 
466 Appellate Body Report on US – Wool Shirts and Blouses , DSR 1997:I, p. 323 at 335.  WT/DS321/R 
 Page 195 
 
 
  of proving its case, the responding party must prove the case it seeks to make in 
response."467 
7.330  We believe that, in arguing that it enjoys a presumption of good faith compliance, the 
European Communities is not merely asserting  its claim of violation of Articles 23.1, 22.8 and 3.7.  
The EC allegation of existence of a presumption of  good faith compliance is only one part – although 
an essential one – of the EC argumentation su pporting its claims.  Moreover, the European 
Communities is not directly asserting that it has comp lied in relation to the conformity of Canada's 
measure with Article 22.8, but that it enjoys, as a matter of principle, a presumption that it complied 
in good faith with its own obligations. 
7.331  On its part, Canada argues as a defence that the European Communities did not comply with 
the recommendations and rulings of the DSB.  One ma y argue that the parties' respective burdens are 
unbalanced because the European Co mmunities, if one agrees with its position, does not have to make 
any particular effort to demonstrate prima facie that it has complied with the recommendations and rulings of the DSB.  However, it should first be recalle d that what is at issue in this case is not directly 
whether the European Communities has complied with  the recommendations and rulings of the DSB, 
but whether Canada complied with its obligations u nder Articles 23.1, 22.8 and 3.7 of the DSU.  By 
taking this route, the European Commu nities takes the risk that its clai ms may be rejected if the Panel 
disagrees with the existence of a presumption of good faith compliance. 
7.332  We therefore conclude that by invoking a presumption of good faith compliance, the 
European Communities is not merely asserting its cl aims under Article 22.8, but rather supporting its 
claims which are, in essence, claims of violati ons by Canada, not claims of compliance by the 
European Communities. 
7.333  We therefore find that the European Commun ities' reliance on a presumption does not amount 
in this case to merely asserting a claim. 
Presumption of good faith 
7.334  The Panel notes that the Appellate Body has, on  several occasions, recalled that the principle 
of good faith applies to WTO Members in their relations under the WTO Agreement.  The Panel 
recalls that, in US – FSC , the Appellate Body stated that: 
"This pervasive principle
 [of good faith] requires both complaining and responding 
Members to comply with the requirements of the DSU (and related requirements in 
other covered agreements) in good faith." (emphasis added)468  
7.335  Furthermore, it seems that the Appellate Body understands the obligati on to comply with the 
requirements of the DSU in good faith as implying that Members are to be presumed to act in good faith. In EC – Tube or Pipe Fittings , the Appellate Body found that: 
"This excerpt demonstrates that the Panel took into account the European 
Communities' responses to its questions before reaching its finding.  It also indicates that the Panel did not rely exclusively on the presumption of good faith
, as Brazil 
suggests, given that some of the Pane l's questions were directed at the  validity  of 
Exhibit EC-12.  If the Panel had placed total reliance on the presumption of good 
faith, it would have simply accepted the Eu ropean Communities' assertion that 
Exhibit EC-12 formed part of the record of the investigation and would not have 
                                                      
467 Appellate Body Report on Japan – Apples , para. 154. 
468 Appellate Body Report on US – FSC , para. 166. WT/DS321/R 
Page 196 
 
 
  posed questions to assess the consistency of Exhibit EC-12 with other evidence 
contained in the record.  Therefore, we are satisfied that the Panel "took steps to 
assure [itself] of the validity of [Exhibit EC-12] and of the fact that it forms part of the contemporaneous written record of th e EC investigation." (footnotes omitted – 
emphasis added)
469 
7.336  As mentioned above, there is no express exclusion of the application of the principle of good 
faith in the DSU or in the WTO Agreement.  As noted by the panel on Korea – Procurement : 
"Article 3.2 of the DSU requires that we seek within the context of a particular 
dispute to clarify the existing provisions of  the WTO agreements in accordance with 
customary rules of interpretation of public international law.  However, the 
relationship of the WTO Agreements to cust omary international law is broader than 
this.  Customary international law app lies generally to the economic relations 
between the WTO Members.  Such internati onal law applies to the extent that the 
WTO agreements do not 'contract out' from it.  To put it another way, to the extent 
there is no conflict or inconsistency, or  an expression in a covered WTO agreement 
that implies differently, we are of the view  that the customary rules of international 
law apply to the WTO treaties and to th e process of treaty formation under the 
WTO."470 
7.337  More precisely, in US – Section 211 Appropriations Act , the Appellate Body recalled that: 
"... where discretionary authority is v ested in the executive branch of a WTO 
Member, it cannot be assumed that the WTO Member will fail to implement its 
obligations under the  WTO Agreement   in good faith.   Relying on these rulings, and 
interpreting them correctly, the Panel conc luded that it could not assume that OFAC 
would exercise its discretionary executiv e authority inconsistently with the 
obligations of the United States under the  WTO Agreement .  Here, too, we agree." 
(emphasis added)471  
7.338  The parties have argued on the relevance of the report in EC – Bananas III (Article 21.5 – 
EC).  The European Communities notes that this  report was never adopted by the DSB. We 
nevertheless recall that the Appellate Body, in Japan – Alcoholic Beverages II , found that panels may 
seek guidance from unadopted panel reports.  In EC – Bananas III (Artic le 21.5 – EC),  the panel 
rejected the EC assertion of a presumption of consis tency.  In that case, the European Communities 
requested the panel to find that its implementi ng measures "must be presumed to conform to WTO 
rules unless their conformity has b een duly challenged under the appropriate DSU procedures".  This 
position seems largely similar to the position adop ted by the European Co mmunities in the present 
case, where it claims that Canada will breach Ar ticle 23 even if it rebuts the presumption of 
compliance because it failed to use the right foru m to contest it (i.e. Article 21.5 of the DSU). 
7.339  The panel in  EC – Bananas III (Article 21.5 – EC) , agreed with the European Communities 
that there was normally no presumption of inconsis tency attached to a Member's measures in the 
WTO dispute settlement system.  This was subse quently confirmed by the Appellate Body in Chile – 
Alcoholic Beverages472and it is now well established that no pr esumption of bad faith can be applied 
to a Member's measure.  However, the panel in EC – Bananas III (Article 21.5 – EC) considered that 
                                                      
469 Appellate Body Report on EC – Tube or Pipe Fittings , para. 127. 
470 Panel Report on Korea – Procurement , para. 7.96. 
471 Appellate Body Report on US – Section 211 Appropriations Act , para. 259 (original footnote 
omitted). 
472 Appellate Body Report on Chile – Alcoholic Beverages , para. 74.  WT/DS321/R 
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  the failure, as of a given point in time, of one Memb er to challenge another Member's measures could 
not be interpreted to create a presumption that th e first Member accepts the measures of the other 
Member as consistent with the WTO Agreement.473 
7.340  First, we find the above reasoning of the Panel in EC – Bananas III (Article 21.5 – EC)  
convincing. 
7.341  Second, in the present case, however, the Europ ean Communities does not actually allege that 
there is a presumption of acceptance by Canada that the measure is consistent with the WTO 
Agreement because Canada failed to challenge the measure.  The European Communities claims that 
there is a presumption of compliance based on the presumption of good faith and that this presumption can only be rebutted in the appropriate forum, i.e. by invoking Article 21.5 of the DSU. 
7.342  Canada argues that the presumption of good faith compliance cannot supersede the 
multilateral authorization of the DSB to Canada to suspend concessions. 
7.343  As already mentioned, we first note that Article 22.2 and 22.7 of the DSU refers to 
"authorization" of the DSB.  Canada has no obl igation under the DSU to apply the sanctions 
authorized by the DSB.
474 Second, we note that Article 22.8 provides that the suspension of 
obligations "shall only be applied until such time  as the measure found to be inconsistent with a 
covered agreement has been removed, or the Member that must implement recommendations or 
rulings provides for a solution to the nullification or im pairment of benefits".  There is no reference to 
the DSB in that phrase and nothing in this provision suggests that a Member suspending concessions can continue to do so as long as the authorization of the DSB has not been repealed by the DSB.  On 
the contrary, it seems that it is for the Member c oncerned to draw the consequences of a removal of 
the violation. In other words, the removal of the measure found to be inc onsistent with a covered 
agreement supersedes the DSB authorization to suspend concessions.  
Is the presumption of good faith compliance rebuttable only in a specific 
forum? 
7.344  We note that the European Communities cl aims that the presumption of good faith 
compliance is rebuttable, but only in the appropria te forum, i.e. by the complaining party in the 
original case taking the initiative of having r ecourse to a dispute settlement procedure under 
Article 21.5 of the DSU.
475  The European Communities alleges a "jurisprudential" need for an 
irrebuttable presumption to fill up a gap in the DSU and allow respondents to exit from post-retaliation situations. 
7.345  Canada argues, on the contrary, that an Ar ticle 21.5 proceeding is  not the only avenue 
available if there is a disagreement as to the adopti on of a compliance measure and that, in any event, 
it is not open exclusively to Canada, but also to the European Communities.
476 
7.346  It is therefore important for the Panel to dete rmine the extent to which the unavailability of 
any legal recourse for the European Communities in a post retaliation situation may justify that the  
presumption of good faith compliance be irrebuttabl e, except through recourse to the procedure 
provided in Article 21.5 of the DSU. 
                                                      
473 Panel Report on EC – Bananas III (Article 21.5 – EC),  para. 4.13. 
474 See, e.g., Canada – Aircraft Credits and Guarantees and Brazil – Aircraft .  In both cases, 
authorization of suspension of concessions has been granted by the DSB but the complaining party has not 
applied the authorized sanction. 
475 EC's reply to Panel question 4(b) after the first substantive meeting. 
476 See Canada's reply to Panel questions 36, 37 and 45 after the first substantive meeting, Annex B-2. WT/DS321/R 
Page 198 
 
 
  7.347  We first note that nowhere does the DSU provide that a presumption of good faith compliance 
should be rebuttable only through recourse to Article 21.5 of the DSU. 
7.348  Second, it appears that, even under th e current DSU, several means seem a priori  to be 
available to the European Commun ities to obtain termination of the suspension of concessions or 
other obligations: 
(a) Good offices and consultations; 
(b) Article 21.5 of the DSU; 
(c) Arbitration under Article 25 of the DSU;  and   
(d) recourse to a normal panel against the conti nuation of the retaliations (as in this case). 
7.349  The Panel is mindful that the option naturally coming to mind when it comes to reviewing 
compliance is the procedure provided under Article 21. 5 of the DSU. The Panel is aware of the broad 
language ("such dispute shall be decided through recourse to  these dispute settlement procedures") 
used in Article 21.5 and that su ch language could be deemed to encompass any procedure available 
under the DSU for the resolution of disputes.  The Pa nel is, however, of the opinion 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.  In this regard, the Panel reads the phrase "including whenever possible resort to the 
original panel" not as meaning that resort to a pane l is generally preferred, but as requesting resort to 
the panelists that reviewed the original case, rather than to other individuals. 
7.350  The Panel also notes that this dispute is eviden ce that a practicable alternative exists to a 
recourse to Article 21.5.  We recall in this respect  that even though the Eu ropean Communities claims 
a violation of the DSU by Canada, its claim under Article 22.8 of the DSU is based on the compliance 
of its implementing measure with the WTO Agreem ent, whether presumed (as part of the second 
series of main EC claims under Article 23.1 read together with Article 22.8 and Article 3.7) or 
demonstrated (as in its alternative "direct" claim of violation of Article 22.8). While Members enjoy 
complete discretion in the way they bring the measu re at issue into conformity with the covered 
agreements, the findings already made by the Panel with respect to Article 23.2(a) and 23.1 of the 
DSU and the findings the Panel will make under Artic le 22.8 will have an impact on whether Canada 
may maintain, suspend or withdraw the suspen sion of obligations it currently applies.  
7.351  We recall that the European Communities consid ered that Article 21.5 was not an avenue 
open to the party claiming compliance, but only to the complainant in the original case.477  Both 
parties have discussed the relevance of the only case where a party found in br each of its obligations 
requested an Article 21.5 panel, i.e. the EC – Bananas III  (Article 21.5 – EC)  panel. 
7.352  We note that, in the EC – Bananas III (Article 21.5 – EC)  case, the panel did not conclude 
that it could not perform its duties under Article 21. 5.  The panel, referring to the comments made by 
Japan as a third party, noted that allowing the de fendant before the original panel to initiate a 
procedure under Article 21.5 presented certain "practi cal problems or anomalies".  The panel was also 
sympathetic to the concerns of India as a third party  that, in an appropriate case, a respondent-initiated Article 21.5 proceeding should be allowed.
478  The Panel concluded: 
                                                      
477 EC's reply to Panel question 1 after the first su bstantive meeting, Annex B-1; EC's second written 
submission, paras. 62-63.   
478 Panel Report on EC – Bananas III (Article 21.5 – EC) , para. 4.18 .  WT/DS321/R 
 Page 199 
 
 
  "In our view, we would not rule out the possibility of using Article 21.5 in such a 
manner, particularly when the purpose of such initiation was clearly the examination 
of the WTO-consistency of implementing measures."479  
7.353  We are therefore not convinced that Article 21.5 is the only avenue available to address a 
claim of compliance by a Member alleging to have  complied with recommendations and rulings of the 
DSB.  Neither do we believe that proceedings under Article 21.5 are open only to the original 
complainant. 
7.354  For these reasons, the Panel does not agree th at 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. 
Conclusion  
7.355  On the basis of the above: 
(a) We note that, under general international law, the corollary to the obligation to 
perform treaty obligations in good faith is the presumption that Members act in good 
faith when performing such obligations. 
(b) We find that the general principle of good faith and the presumption of good faith 
performance of a Member's obligations appl y in relation to Members' obligations 
under the WTO Agreements, including the DS U, as interpreted in accordance with 
customary rules of interpretation of public international law. 
(c) We also note that there is no presumption of  bad faith under gene ral international law 
and find that no presumption of bad faith applies under the DSU as interpreted in accordance with customary rules of interp retation of public international law. 
(d) We find that the presumption of good fa ith compliance alleged by the European 
Communities is at best legally identical to the principle of good faith performance of 
treaty obligations.  We do not find in th e DSU as interpreted in accordance with 
customary rules of interpretation of public international law any ground supporting a specific presumption of compliance for Members having to implement DSB recommendations and rulings. 
(e) Moreover, we find no support in the DSU to suggest that this presumption may only 
apply to the measure taken by the Europ ean Communities and not to the measures 
adopted by Canada.   
(f) As a consequence, while we agree with the existence of a presumption of good faith 
compliance, we do not agree with the Eur opean 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, b ecause it applies to measures taken by all 
parties, must be rebuttable before this Pane l.  Just as the EC allegations are intended 
to rebut the presumption of good faith confor mity of Canada's retaliatory measures 
with Article 22.8 of the DSU, Canada shoul d be allowed to rebut the presumption of 
EC compliance by proving actual non-compliance. 
                                                     
 
479 Ibid. WT/DS321/R 
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  7.356  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 Eu ropean Communities under the WTO Agreement. The 
European Communities has an obligation to co mply with the WTO Agreement in general480 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.481  
7.357  We have also found above that  we could not agree with th e European Communities and base 
our findings of violation of Article 23.1 read in conjunction with Article 22.8 and 3.7 of the DSU on 
an irrebuttable presumption of good faith complia nce by the European Co mmunities.  Whereas the 
European Communities enjoys a presumption of good faith compliance, this presumption is rebuttable. We agree that, for all practical purpo ses, this amounts to addressing the EC "alternative" 
claim of violation of Article 22.8 per se .  However, this is not the result of us merely disregarding the 
order in which the European Communities wanted us to review this case.  We are still reviewing the 
EC claim of violation of Article 23.1, read together  with Articles 22.8 and 3.7. We are not reviewing a 
claim of violation of Article 22.8 in isolation. 
(iii) Does the Panel have jurisdiction to address the compliance of the EC implementing measure 
with the SPS Agreement? 
7.358  We are mindful that our terms of reference do not include any provision of the 
SPS Agreement  referred to by the parties during these pro ceedings and that "[A] panel cannot assume 
jurisdiction that it does not have."
482  Stricto sensu , the conformity of the EC measure with the 
provisions of the SPS Agreement  referred to in this case is not part of our mandate.  This means that 
reviewing alleged violations of the SPS Agreement  is not part of our mandate either and that we are 
not expected to make findings  on those provisions. 
7.359  However, this absence of reference to the SPS Agreement  is understandable since the 
European Communities is not seeking a finding of violation of the SPS Agreement  by the responding 
party. 
7.360  Moreover, we note that the European Communities claims in its request for establishment of a 
panel that Canada breached Article 22.8  
"Canada has acted inconsistently with Artic le 22.8 of the DSU by failing to apply the 
suspension of concessions or other obligati ons only until such time as the measure 
found to be inconsistent with a covere d agreement has been removed, or the 
implementing Member has provided a solution to the nullification or impairment of 
benefits previously caused to Canada."483 
7.361  This statement, which essentially repeats the terms of Article 22.8, must be read in 
conjunction with other relevant remarks of the Eu ropean Communities in its request for establishment 
of a panel.  For instance, in the introduc tion, the European Co mmunities stated that: 
"[t]his request concerns Canada's con tinued suspension of concessions and other 
obligations under the covered agreements , without recourse to the procedures 
                                                      
480 See Article XVI:4 of the WTO Agreement. 
481 As explicitly expressed in Article 2.2 of the Char ter of the United Nations, as well as in Article 26 
of Vienna Convention on the Law of Treaties. 
482 Appellate Body Report on India – Patents (US) , para. 92. 
483 WT/DS321/6.  WT/DS321/R 
 Page 201 
 
 
  established by the DSU, after the Europ ean Communities has removed the measures 
found to be inconsistent with WTO law in case DS 48 , European Communities – 
Measures concerning meat and meat products (Hormones) ('EC – Hormones' )."484 
and subsequently: 
"The European Communities subsequently removed the measure found to be 
inconsistent with a covered agreement.  It adopted Directive 2003/74/EC of the 
European Parliament and of the Counc il 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 thyrosta tic action and of beta-agonists.  The 
Directive was published and entere d into force on 14 October 2003. 
In conformity with the recommendations and rulings of the DSB and the covered 
agreements, the new EC legislation is b ased on comprehensive risk assessments, in 
particular on the opinions of the independe nt Scientific Committee on Veterinary 
Measures relating to Public Health.  The ri sk assessments focussed on potential risks 
to human health from hormone residues in bovine meat and meat products, in 
particular such risks arising from residues of six hormonal substances: oestradiol-17 β, 
testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate.  In carrying out the risk assessment s, the European Communitie s initiated and funded a 
number of specific scientific studies and research projects.  It addressed specific 
requests to the United States, Canada a nd third countries to provide any recent 
scientific data and information in their possession.  It took account of the findings of 
various independent expert bodies.   
In light of the risk analyses carried out, the European Communities concluded that the 
avoidance of intake of oestradiol-17 β is of absolute importance to human health and 
that, consequently, the placing on the market  of meat containing this substance should 
be prohibited.  With respect to testoste rone, progesterone, trenbolone acetate, zeranol 
and melengestrol acetate, and on the basis of the available pertinent scientific 
information reflected in the above-me ntioned risk analyses, the European 
Communities provisionally prohibited the placing on the market of meat containing 
these substances because the relevant sc ientific evidence was insufficient. 
On 27 October 2003, the European Commun ities notified to the DSB the adoption, 
publication and entry into force of this Directive as well as the preceding scientific 
risk assessments.  In the same communicati on, the European Communities explained 
that it considers itself to have fully impl emented the recommendations and rulings of 
the DSB in the EC – Hormones dispute and that, as a consequence, it considers 
Canada's suspension of concessions vis-à-vis the European Communities to be no 
longer justified.
485 
7.362  In the Panel's view, one instance of violation of Article 22.8 occurs when the suspension is 
maintained even though the "measure found to be inconsistent ... has been removed".  The lengthy 
explanation above demonstrates that the claims of  the European Communities under Article 22.8 are 
related to its alleged removal of the "m easure found to be inconsistent" with the SPS Agreement . 
7.363  The Panel notes the arguments of the parties in re ply to a question on its jurisdiction to review 
the compatibility of the EC implementing measure with the SPS Agreement .  Canada replied that the 
                                                      
484 WT/DS321/6 (emphasis added). 
485 WT/DS321/6 (original footnotes omitted). WT/DS321/R 
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  Panel has jurisdiction to review the consistency of the European Communities' new measure with 
Articles 3.3, 5.1 and 5.7 of the SPS Agreement.  Canada considers that the Panel's determination that 
the European Communities has actually removed its  offending measure is a prerequisite to any 
finding that Canada has breached Article 22.8 of the DSU by maintaining its suspension of 
concessions.486 The European Communities replied that, in light of the Appellate Body practice, the 
Panel has, in the present case, no jurisdiction to address Articles 3.3, 5.1 and 5.7 of the 
SPS Agreement .  The European Communities adds that, at b est, one could venture to draw an analogy 
to affirmative defences.487 
7.364  We do not consider that an analogy could be drawn between the reference by the parties to 
provisions of the SPS Agreement  in this case and the notion of "affir mative defence". In the opinion of 
the Panel, an affirmative defence would imply that the responding party invoke a provision of a 
covered agreement as a justification for a breach of  another provision.  This is not the case here.  
Canada does not argue the incompatibility of the EC implementing measure as a justification  for a 
breach of Article 22.8.  Nor does it seem to invo ke the incompatibility of the EC implementing 
measure as a justification for a breach of Article 23.   The Panel concludes that any jurisdiction it may 
have to review the compatibility of the EC implementing measure with the SPS Agreement  cannot 
result from the fact that Canada would have invoked the SPS Agreement , including as an affirmative 
defence. 
7.365  We also note the argument of th e European Communities that:  
"[this] issue is a perfect illustration of the problems arising if an implementing 
member is forced to bring a case allegi ng compliance, instead of the original 
complaining party bringing a case alleging n on compliance ...  The terms of reference 
become wholly devoid of their meaning and the panel's jurisdiction turns into a moving target depending on whatever allega tions of inconsistency the "defending" 
parties will come up with.  It is clear that the dispute settlement system is not 
designed to accommodate such a procedural constellation."
488 
7.366  We recall that, as mentioned above, the EC requ est for establishment of a panel is silent 
regarding the SPS Agreement .  We do not agree, however, that the terms of reference of the Panel 
become wholly devoid of meaning because of the re ferences made by the parties to provisions of the 
SPS Agreement .  Neither do we consider that this modifies our terms of reference.  We recall that the 
European Communities claims a violation by Canada of Article 22.8 of the DSU which is premised on 
the compliance of the EC implementing measure (Directive 2003/74/EC) with the SPS Agreement .  A 
discussion of the compatibility of the measure with provisions of the SPS Agreement  is, thus, the 
immediate consequence of the inclusion of Ar ticle 22.8 of the DSU in the EC request for 
establishment of a panel. As such, our mandate re mains defined by the EC request for establishment 
of a panel. 
7.367  We are mindful that the responding party could bring several allegations of violations with 
respect to the EC implementing measure. We not e however that the European Communities did not 
exclude the possibility for the Panel to consider th e actual compatibility of Directive 2003/74/EC with 
the SPS Agreement  as part of its alternative "direct" clai m under Article 22.8 of the DSU.  Such a 
review would imply that the Panel address the comp atibility of the EC implementing measure with the 
                                                      
486 Canada's reply to Panel questions after the first substantive meeting, question 65, Annex B-2, 
para.55. 
487 EC's reply to Panel questions after the first substantive meeting, question 65, Annex B-1, 
paras. 239-241. 
488 EC's reply to Panel question 65 after the first substantive meeting, Annex B-1, para. 240.  See also 
EC's reply to Panel question 62 after the first substantive meeting, Annex B-1.  WT/DS321/R 
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  SPS Agreement .  While the Panel must comply with its  terms of reference, nothing in the DSU 
prevents the Panel from considering the compatib ility of the EC implementing measure with the 
SPS Agreement  if this is necessary in order to make the fi ndings required by those terms of reference. 
7.368  Moreover, we note that, whereas the European Communities "[did] not believe that it [was] 
necessary for the Panel to look into any scientific issue to make its necessary findings and rulings 
within its terms of reference in this particular  case", the European Commun ities did not exclude that 
the Panel could address the scientific issues at stak e since it suggested that, in such a case, the 
consultation of scientific experts would be absolutely necessary.489  The parties have extensively 
discussed the question of the compa tibility of the EC implementing measure with certain provisions 
of the SPS Agreement , have agreed to the consultation of experts on the scientific issues relating to the 
compatibility of the measure with the SPS Agreement  and have extensively commented on these 
scientific issues. 
7.369  We conclude from this that the Panel should be  entitled to determine whether the European 
Communities has removed the measure found to be inc onsistent with a covered agreement in order to 
establish whether Article 22.8 has been breached by Canada. Indeed, the Panel considers that, since 
the European Communities made a claim of violation of Article 22.8, the compatibility of its implementing measure becomes ipso facto  an issue that the Panel will have to address if it reviews 
any of the EC claim relating to Article 22.8.  The fact that the European Communities alleges that it 
benefits from a presumption of good faith compliance does not affect this conclusion.  Under both of 
its Article 22.8 claims, the European Communities needs to demonstrate that it has removed the 
measure found to be inconsistent.  The presumpti on of good faith compliance does not affect what 
needs to be demonstrated.  It simply shifts the bur den of proof since, in application of the presumption 
of good faith compliance, the European Communities h as, in this dispute, made a prima facie case of 
violation of Article 22.8 which Canada has to rebut. 
7.370  The Panel notes that, pursuant to its mandate, it is  only expected to make findings of violation 
in relation to Article 22.8 of the DSU, the breach of  which is alleged by the complaining party.  The 
Panel nonetheless recalls that, for the reasons menti oned above and irrespective of which one of the 
two Article 22.8 claims is addressed, it will have to  determine whether the European Communities has 
removed the measure found to be inconsistent.  Since what has to be demonstrated is a consistency or 
inconsistency with provisions of the SPS Agreement , this is not really an issue of fact but a legal 
question, which adds to the complexity of the situation before the Panel.  
7.371  The Panel is fully conscious of the cha llenges attached to assessing whether the EC 
implementing measure is not inconsis tent with the provisions of the SPS Agreement  referred to by the 
parties in this case.  The Panel also notes that, in  a case like this one, it is largely dependent on the 
responding party, not on the complainant, as fa r as allegations of incompatibility of the EC 
implementing measure are concerned.  However, we be lieve that it is in the interest of the responding 
party to demonstrate the incompatibility of the im plementing measure.  We can count on its full 
cooperation in this respect, and we have experienced it in this case.  The Panel also agrees that, since 
the allegations of violation of the SPS Agreement  were not exhaustively listed in its terms of reference 
and depended on the parties raising them in the cour se of the procedure, this could have made it 
difficult to circumscribe the scope of its review under the SPS Agreement .  We note, however, that in 
this particular case the legal arguments regardi ng the conformity of the EC implementing measure 
with the SPS Agreement  were all raised early in the proceedings and that no party complained that it 
had not been given sufficient opportunity to comment on the other party's legal arguments.  
                                                     
 
489 EC's reply to Panel question 74 after the first substantive meeting, Annex B, para, 275.  The Panel 
notes that the European Communities raised an alternativ e claim of violation of Article 22.8 of the DSU and 
Articles I and II of the GATT 1994, based on its a lleged actual compliance with the recommendations and 
rulings of the DSB in the EC – Hormones  case WT/DS321/R 
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  7.372  We therefore conclude that we should addr ess the compatibility of the EC implementing 
measure with the provisions of the SPS Agreement  referred to by the parties to the extent necessary to 
determine, with respect to the EC claim relating to  Article 22.8, whether the EC "measure found to be 
inconsistent" in the EC – Hormones  case has been removed.  We are mindful of the procedural 
problems raised by this approach, but we do not cons ider that, by proceeding in this manner, we are 
exceeding our jurisdiction to the exte nt that such a review is necessary in order to address the EC 
claims under Article 22.8 of the DSU. 
7.373  The Panel notes in this respect that it is not the first time that a dispute settlement entity, when 
confronted with a procedurally a-typical issue, decided to adopt a pragmatic solution and perform  functions similar to those of an Article 21.5 panel.  In the Article 22.6 arbitration in the EC – 
Bananas III  case the arbitrator decided to adopt the most "logical way forward": 
"4.10 ... the European Communities argues that we should not consider the 
consistency of its new banana  regime.  First, it argues that to do so would go beyond 
our terms of reference, which it suggests are limited to determining the level of 
suspension and its equivalence to the level of nullification or impairment.  As noted 
above, however, setting the level of nullif ication or impairment may require 
consideration of whether there is nullification or impairment flowing from a WTO-
inconsistency of the new banana regime." 
7.374  We too believe that our approach to consider, to the extent necessary, the compatibility of the 
EC implementing measure with the SPS Agreement  is the most logical way forward under the 
circumstances, having regard to our duty to assist th e parties and the DSB in solving this dispute and, 
in particular, to determine whether, as claimed by the European Communities, there is a violation of 
Article 23.1 in conjunction with Article 22.8 and Articl e 3.7 of the DSU.  This is consistent with our 
duty to make an objective assessment of the matter before us pursuant to Article 11 of the DSU.
490 
7.375  We also note that panels have not hesitated in the past to consider ot her provisions than those 
on which findings had been requested as part of the context of those provisions.491  
7.376  Therefore, the Panel believes that these are suffi cient reasons for it to conclude that it has 
jurisdiction to consider the compatibility of the EC 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.     
(c) Burden of proof 
7.377  We note that the European Communities consid ers that it has made a prima facie case of 
violation of the DSU provisions, and that, since it cannot be requested to prove a negative, it is for 
Canada to prove a violation of the SPS Agreement by the EC implementing measure.  The European 
Communities also argues that it enjoys a pr esumption of good faith compliance with the 
recommendations and rulings of the DSB in the EC – Hormones  dispute.492  Canada considers that 
this dispute does not concern an EC measure take n as part of its regular day-to-day business of 
governing, prior to the engagement of the WTO di spute settlement mechanis m. Nor does it concern a 
measure that the EC has taken to comply within  the reasonable period of time, and prior to the 
adoption of DSB authorization to suspend c oncessions. Any measure taken by the European 
Communities in either of these scenarios would be  presumed to comply with its international 
obligations unless otherwise challenged.  Rather, the dispute before this Panel concerns the failure of 
                                                      
490 See Section VII.C.2.(a) above. 
491 Panel Report on India – Quantitative Restrictions , para. 5.26. 
492 EC's first written submission, paras. 90-92.  WT/DS321/R 
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  the European Communities to correct , within the reasonable period of time, a measure that had been 
found by the DSB to be inconsistent with the WT O obligations of the European Communities, and as 
a result the DSB authorized Canada to suspe nd concessions. For Canada, the existence of the 
authorization by the DSB of Canada's measure dis tinguishes this case from those situations in which a 
general presumption of compliance would apply to the EC measure. 
7.378  The principles regarding allocation of burden of proof have been well established since the 
early days of the WTO dispute settlement system and the Panel did not deem it necessary to repeat 
them in relation to the other claims of the Eur opean Communities. However, having regard to the 
importance given by the parties to the question of bu rden of proof in relation to the compatibility of 
the EC measure with the SPS Agreement , the Panel considers that it needs to clarify how it addressed 
burden of proof in relation to the EC claim under Article 22.8. 
7.379  First, we deem it necessary to recall that, in US – Wool Shirts and Blouses , the Appellate 
Body stated that: 
"... various international tri bunals, including the International Court of Justice, have 
generally and consistently accepted and app lied the rule that the party who asserts a 
fact, whether the claimant or the resp ondent, is responsible for providing proof 
thereof. Also, it is a generally-accepted ca non of evidence in civil law, common law 
and, in fact, most jurisdictions, that the burden of proof rests upon the party, whether 
complaining or defending, who asserts the affirmative of a particular claim or 
defence."493  
7.380  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 othe r panel established under 
Article 6 of the DSU.  Indeed, as stated by the Co mplainant itself, this case is about a measure taken 
by Canada.  The Panel does not agree with Canada th at the fact that this di spute takes place in the 
context of the EC alleged late compliance with the recommendations and rulings of the DSB in the 
EC – Hormones  dispute should have any 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 Canada breaches Article 22.8 of the 
DSU. 
7.381  Yet, one of the particularities of this case is that the European Communities claim of violation 
of Article 22.8 of the DSU by Canada is premised  on the removal of the EC measure found to be 
inconsistent with the SPS Agreement . In other words, in order to demonstrate that Canada has 
breached Article 22.8, the European Communities also  alleges that its implementing measure is itself 
in conformity with the SPS Agreement . 
7.382  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 alle gations.  We agree, however, with the European 
Communities that in a case like this one, this coul d generate for the complainant at the beginning of 
the proceedings a situation equiva lent to having to "prove a negative", since the spectrum of 
provisions against which the legality of the EC meas ure may have to be reviewed remains very broad 
as long as the respondent has not made its own alle gations of inconsistenc y of the implementing 
measure.  However, we recall that we found above that the European  Communities enjoyed a 
presumption of good faith compliance, even though th at presumption was rebuttable before this Panel.  
As soon as the European Communiti es established a prima facie case494 thanks to the presumption of 
                                                      
493 Appellate Body Report on US – Wool Shirts and Blouses , p. 14.  See also Appellate Body Report on 
Canada – Dairy (Article 21.5 – New Zealand and US II) , para. 66. 
494 See Appellate Body Report on EC – Hormones , para. 98. WT/DS321/R 
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  good faith compliance, the burden shif ted to Canada to rebut that presumption.  We recall that "... a 
prima facie case is one which, in the absence of e ffective refutation by the defending party, requires a 
panel, as a matter of law, to rule in favour of the complaining party presenting the prima facie case."
495 We believe that Canada sufficiently refuted the EC allegation of compliance in its first 
written submission through positive evidence of breach of the SPS Agreement  by the European 
Communities.  In its subsequent submissions befo re the Panel, the European Communities responded 
to the allegations of violation made by Canada.  Thus, the European Communities never actually had 
to "prove a negative" in this case. 
7.383  While the presumptions based on good faith enjoye d by each party may have played a role in 
the burden of proof in the early st age of the Panel proceedings, it is the opinion of the Panel that they 
eventually "neutralized" each ot her since each party also subm itted 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.496  Thereafter, when considering wh ether an allegation had been proven 
or not, the Panel followed the practice of other panels to weigh all the evidence before it. 
(d) Compatibility of the EC implementing measure with the provisions of the SPS Agreement  
(i) The EC implementing measure 
7.384  As already noted, the Europ ean Communities has had a ban on the placing on the market, 
including a ban on the importation, of beef treat ed with certain hormones for growth promotion 
purposes since 1988.  The hormones concerned are oestradiol-17 β, testosterone, progesterone, 
trenbolone acetate, zeranol and melengestrol acetate.  We note that the European Communities stated 
in its first submission that the DSB recommendations in the EC – Hormones  cases had been 
implemented through the adoption,  on 22 September 2003, of Directive 2003/74/EC the transposition 
deadline of which was 14 October 2004. 
7.385  The European Communities claims that the Directive is based on a risk assessment the results 
of which "sufficiently warrant"  the definitive im port prohibition on meat and meat products treated 
with oestradiol-17 β and "provide the available pertinent information" on the basis of which the 
provisional prohibition regarding the other five hormones has been enacted. 
7.386  The Panel understands that, according to the European Communities, its risk assessment: 
(a) is composed of three opinions issued by the EC Scientific Committee on Veterinary 
measures relating to Public Health (SCV PH) in 1999, 2000 and 2002, the 2000 and 
2002 Opinions constituting reviews of the 1999 Opinion; 
(b) is supported by the 17 studies initiated and funded by the European Communities 
between 1998 and 2001 in order to obtain as much as possible of the missing scientific information that was identified by  the panel and the Appellate Body in the 
EC – Hormones  case.  
7.387  Specifically, the European Communities argues that the 17 scientific studies it commissioned 
resulted in numerous publications which, along with  the pre-existing scientific data, were examined 
by the SCVPH.  The SCVPH issued its first op inion entitled "Assessment of Potential Risks To 
Human Health From Hormone Residues in Bovine Meat And Meat Products" on 30 April 1999 
(hereafter the "1999 Opinion").   
                                                     
 
495 Appellate Body Report on EC – Hormones , para. 104. 
496 See Appellate Body Report on Japan – Apples , para. 154.  WT/DS321/R 
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  7.388  The 1999 Opinion contained the following major conclusions:  
(a) As concerns excess intake of hormone residu es and their metabolites, and in view of 
the intrinsic properties of hormones and ep idemiological findings, a risk to the 
consumer had been identified with differen t levels of conclusive evidence for the six 
hormones in question. 
(b) 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 effect s.  The data available did not, however, 
allow a quantitative estimate of the risk. 
(c) For the other five hormones at issue, 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. 
(d) For all six hormones endocrine, developm ental, immunological, neurobiological, 
immunotoxic, genotoxic and carcinogenic effects could be envisaged.  Of the various susceptible risk groups, prepubertal childre n was the group of greatest concern.  
Again the available data did not enable a quantitative estimate of the risk. 
(e) 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.
497 
7.389  In 2000, the SCVPH reviewed two reports, one from the Committee on Veterinary Medicinal 
Products and one from the UK Veterinary Products  Committee, to determine whether the science 
contained within warranted altering the findings an d conclusions of the 1999 Opinion.  In May 2000, 
the SCVPH concluded the following: 
"The reports of the UK's Veterinary Products Committee subgroup and of the 
Committee on Veterinary Medicinal Products presented for review to the Scientific 
Committee, as well as recent scientific info rmation, did not prov ide convincing data 
and arguments demanding revision of the conclusions drawn in the opinion of the 
SCVPH of April 30th, 1999, on the potential risks to human health from hormone residues in bovine meat and meat products. 
The SCVPH discussed again the obvious gaps  in the present knowledge on target 
animal metabolism and residue dispositi on of the hormones under consideration, 
including the synthetic hormones.  The SC VPH expects that the ongoing EU research 
programs will provide additional data on both topics."
498 
7.390  Finally, in 2002, the SCVPH reviewed both the 2000 Opinion and the 1999 Opinion and 
found that review of the 17 studies launched by  the European Commission and recent scientific 
literature allowed the following conclusions: 
(a) Ultra-sensitive methods to detect residues of hormones in animal tissues had become 
available, but needed further validation. 
                                                      
497 1999 Opinion, p. 73, Exhibit CDA-2. 
498 2000 Opinion, p. 4, Exhibit CDA-4. WT/DS321/R 
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  (b) 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 bioavailability499 in rodent experiments.  Thus, the consequence of their 
consumption needed to be considered in a risk assessment. 
(c) Experiments with heifers, one of the majo r target animal groups for the use of 
hormones, indicated a dose-dependent incr ease 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.  There was also a dose-dependent increase in residue levels following the oral  administration of melengestrol acetate at 
doses exceeding approved levels, with a corresponding increased risk that 
contaminated meats could enter the food chain. 
(d) 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 vitro
500 experiments indicated that oestrogenic compounds might  alter 
the expression of an array of genes.  Cons idering that endogenous oestrogens also 
exerted these effects, the data highlighted the diverse biological effects of this class of 
hormones. 
(e) No new data regarding testoste rone and progesterone relevant  to bovine meat or meat 
products were available.  However, it w as 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 da ta needed further clarification as they 
might influence a risk assessment rela ted to tissue residues of these compounds. 
(g) Zeranol and trenbolone acetate had been tested for their mutagenic and genotoxic 
potential in various systems with differe nt endpoints.  Both compounds exhibited 
only very weak effects. 
(h) Data on the genotoxicity of melengestrol acetate indicated only weak effects.  
However, pro-apoptotic effects were note d in some cell-based assays, which were 
attributed to the impurities in commercial formulation.  Further experiments should 
clarify the toxicological significance of these impurities. 
(i) Model experiments with rabbits treated with zeranol, trenbolone acetate or 
melengestrol acetate, mirroring their use in  bovines, were designed to study the 
consequences of pre- and perinatal expos ure to exogenous hormones.  All compounds 
crossed the placental barrier easily and influenced to varying degrees the 
development of the foetus, at th e doses used in the experiments. 
                                                      
499 Bioavailability is the capacity of a substance to enter the general blood circulation and to diffuse 
into the whole body of the animal or the human being admi nistered this substance, or the fraction of a dose of a 
substance that is available for system ic circulation (replies of Dr. Boisse au, Dr. Boobis and Dr. Guttenplan to 
Panel question 43 to the experts, Annex D, paras. 344-357). 
500 In vitro  means outside of the body, usually in a cell-ba sed system in a test tube or culture dish. 
(Transcript of the Panel meeting with the ex perts, Annex G, para. 96 (Dr. Boobis)).  WT/DS321/R 
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  (j) Epidemiological studies with opposite-sexed twins suggested that the exposure of the 
female co-twin in utero  to hormones resulted in an increased birth weight and 
consequently an increased adult breast cancer risk. 
(k) Several studies were devoted to the potentia l impact of the extensive use of hormones 
on the environment.  Convincing data were  presented indicating the high stability of 
trenbolone and melengestrol acetate in the environment, whereas preliminary data 
were provided on the potential detrimenta l effects of hormonal compounds in surface 
water. 
7.391  After re-appraisal of the data from the 17 st udies and recent scientific literature, the SCVPH 
confirmed the validity of its previous Opinions (in 1999 and 2000) on the Assessment of Potential 
Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products, and that no amendments to those opinions were justified.
501 
7.392  A year and a half later, the European Par liament and the Council of the European Union 
amended Directive 96/22/EC, which was the subject of the original EC – Hormones  dispute, by 
adopting Directive 2003/74/EC.  In Directive 2003/ 74/EC, the European Co mmunities restated 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-initiating and tumour-promoting effects and that the 
data currently available do not make it possibl e to give a quantitative estimate of the risk."502 
7.393  The European Communities went on to conclude in its amended Directive that oestradiol-17 β 
"can potentially be used in all farm animals a nd residue intake for all segments of the human 
population and in particular the susceptible groups at high risk can therefore be especially relevant.  
The avoidance of such intake is of abso lute importance to safeguard human health."503 
7.394  Finally, the European Communities concluded that  in order to achieve its chosen level of 
protection from the risks posed, in particular to human health, by the routine use of these hormones 
for growth promotion and the consumption of resi dues found in meat derived from animals to which 
these hormones have been administered for growth  promotion, it was necessary to maintain the 
permanent prohibition laid down in Directive 96/22/EC on oestradiol-17 β, and provisionally ban the 
other five hormones at issue. 
(ii) Scope of the Panel review 
7.395  Given the particular circumstances under which we  engage in a review of the compatibility of 
the EC implementing measure with the SPS Agreement , we deem it necessary to clearly circumscribe 
the scope of our review under that Agreement. 
7.396  Indeed, the EC claim of violation of Article 22.8 of the DSU by Canada is premised on the 
alleged compatibility of the EC implementing measure with the SPS Agreement .  We note in this 
respect that the European Communities itself stated in its first written submission that: 
"The new Directive provides that the use fo r animal growth promotion of one of the 
six hormones in dispute is permanently prohi bited while the use of the other five is 
provisionally forbidden.  It is based on a comprehensive risk assessment and, thus, is 
fully compliant with the DSB recommenda tions and rulings. In particular, as 
stipulated by the Appellate Body,  the r esults of the risk assessment  "sufficiently 
                                                      
501 2002 Opinion, pages 21-22 (Exhibit CDA-7). 
502 EC Directive 2003/74/EC. 
503 Directive 2003/74/EC, whereas clause 9. WT/DS321/R 
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  warrant" the definite import prohibition rega rding one of the hormones (Article 5.1 of 
the SPS Agreement ),504 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 the rulings and 
recommendations in the Hormones  case."
505 
7.397  In its subsequent submissions, the European Communities has argued the compatibility of its 
implementing measure with the provisions referred to in this quotation (i.e. Article 5.1 and 5.7).   
7.398  We note that Canada argues an incompatib ility of the EC implementing measure with 
Article 5.1 with respect to the import ban rela ting to meat and meat products treated with 
oestradiol-17 β.  Canada also alleges an incompatibility of the EC implementing measure with 
Article 5.7 with respect to the provisional impor t ban on meat and meat products treated with 
testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate.  Canada also argues 
that the European Commun ities has not demonstrated that the relevant international standards for 
hormone growth promoters are insufficient to achie ve its appropriate level of protection and thus 
breaches Article 3.3 of the SPS Agreement .  
7.399  As already mentioned above, we consider that  we must determine whether the European 
Communities has removed the measure found to be in consistent with the covered agreement or has 
provided a solution to the nullification or impairment of benefits.  Therefore, we conclude that we 
need to review the EC measure against (a) th e recommendations and rulings of the DSB in the EC – 
Hormones  case and (b) the provisions which the Europ ean Communities claims to comply with as 
part of its claim of violation of Article 22.8 of the DSU by Canada.  
7.400  We also agree with the European  Communities that it is difficult  for the complainant in a case 
like this one to identify all potential problems of incompatibility.  We see other difficulties if, in cases 
like this one where a finding of violation by a Memb er is conditioned by the compliance of a measure 
of the complainant with the WTO Ag reement, the scope of review of that measure is defined only by 
the complainant.  Indeed, the complainant could limit  the scope of the panel review to provisions with 
which it believes that its measure is most likely to be found compatible. 
7.401  In that context, we find 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.506  We note that Canada originally 
argued that the European Communities breached Article 5.1 and 5.7 of the SPS Agreement .  In its 
second submission, it also argued a violation of Article 3.3 of the SPS Agreement  but, unlike the 
United States in WT/DS320, Canada did not raise any argument in relation to a violation of other 
paragraphs of Article 5 of the SPS Agreement . 
7.402  We conclude that we shall review, to the extent necessary, the compatibility of the EC 
implementing measure with Articles 5.1, 5.7 and 3.3 of the SPS Agreement . We therefore proceed 
with a review of the compatibility of the EC im plementing measure with those provisions in the 
following sections, once we have addressed other procedural issues. 
                                                      
504 The European Communities refers to the Appellate Body Report on EC – Hormones , para. 253 
lit. (l). 
505 EC's first written submission, para. 17. 
506 We are aware of the risk that the responding party may make a new allegation of violation at a late 
stage of the proceedings, thus making it difficult for the complainant to reply to this allegation.  We nonetheless 
consider that such a circumstance will not have any impact on due process as long as the complaining party is 
given sufficient opportunities to comment.  WT/DS321/R 
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  (iii) Standard applicable to the review of the compa tibility of the EC implementing measure with 
the SPS Agreement  
7.403  We believe that, in light of the importance and complexity of the scientific information 
provided by the parties and the experts, it is necessary to lay down the way we plan to review all this 
information. 
7.404  As recalled by the Appellate Body in EC – Hormones , the standard of review applicable to 
legal and factual issues regarding measures reviewed against the SPS Agreement  is found in Article 11 
of the DSU which reads in relevant part that "...  a panel should make an objective assessment of the 
matter before it, including an objective assessment of the facts of the case". 
7.405  In EC – Hormones , the Appellate Body recalled that: 
"So far as fact-finding by panels is concer ned, their activities are always constrained 
by the mandate of Article 11 of the DSU; the applicable standard is neither de novo  
review as such, nor "total deference", but  rather "the objective assessment of the 
facts."507  
7.406  The Appellate Body further noted that "under current practice and systems, [panels] are in 
any case poorly suited to engage in such a [ de novo ] review."508 
7.407  We note that we have a duty to consider the evidence presented to us and to make factual 
findings on the basis of that evidence. It is also  generally within our discretion to decide which 
evidence we choose to utilise in making findings.509  Likewise, a panel is not expected to refer to all 
statements made by the experts advising it and should be allowed a substantial margin of discretion as 
to which statements are useful to refer to explicitly510 as long as we do not deliberately disregard or 
distort evidence.511 
7.408  We also recall that we consulted six scientif ic experts individually, and not as an expert 
review group.  This may have some consequences in terms of the sometimes diverging views which 
they expressed.  We note that, in EC – Hormones , the Appellate Body considered with respect to 
divergent views taken into account in risk assessment that: 
"We do not believe that a risk assessment has to come to a monolithic conclusion that 
coincides with the scientific conclusion or view implicit in the SPS measure. The risk 
assessment could set out both the prevaili ng view representing the "mainstream" of 
scientific opinion, as well as the opinions of scientists taking a divergent view. 
Article 5.1 does not require that the risk  assessment must necessarily embody only 
the view of a majority of the relevant scientific community … In most cases, 
responsible and representative governments tend to base their legislative and administrative measures on "mainstream" scientific opinion. In other cases, equally 
responsible and representative governments ma y act in good faith on the basis of 
what, at a given time, may be a divergent opinion coming from qualified and respected sources. By itself, this does not necessarily signal the absence of a 
reasonable relationship between the SPS measure and the risk assessment, especially 
where the risk involved is life-threatening in  character and is perceived to constitute a 
                                                     
 
507 Appellate Body Report on EC – Hormones , para. 117. 
508 Appellate Body Report on EC – Hormones , para. 117. 
509 Appellate Body Report on EC – Hormones , para. 135. 
510 Appellate Body Report on EC – Hormones,  para. 138. 
511 Appellate Body Report on EC – Hormones , para. 139. WT/DS321/R 
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  clear and imminent threat to public health and safety. Determination of the presence 
or absence of that relationship can only be done on a case-to-case basis, after account 
is taken of all considerati ons rationally bearing upon the issue of potential adverse 
health effects."512 
7.409  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 expert s' views and thus obtain a more complete picture 
both of the mainstream scientific opinion and of any divergent views. 
7.410  Likewise, in EC – Asbestos,  the Appellate Body stated that:  
"In justifying a measure under Article XX(b) of the GATT 1994, a Member may also 
rely, in good faith, on scientific sources which, at that time, may represent a divergent, but qualified and respected, opinion. A Member is not obliged, in setting 
health policy, automatically to follow what, at a given time, may constitute a majority 
scientific opinion. Therefore, a panel need not, necessarily, reach a decision under Article XX(b) of the GATT 1994 on the basis of the "preponderant" weight of the 
evidence."
513 
7.411  We note that, in some circumstances, only one or two experts have expressed their views on 
an issue.  Sometimes these views were similar or co mplemented each other.  In other circumstances, a 
larger number of experts expressed opinions and,  sometimes, they expressed diverging opinions. 
While, on some occasions, we 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 decided 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 a nd evidence. As we have told the parties and the 
experts during these proceedings, this Pa nel is not composed of scientists.514  The experts were also 
made fully aware of their role – which was inter alia  to present scientific issues to the Panel members 
in a way that could be understood by them – and of the role of the Panel in the WTO dispute 
settlement system – which is inter alia  one of trier of fact.  In assessing the scientific advice received 
from the experts, we also fully took into account the comments of the parties, when appropriate.  
                                                      
512 Appellate Body Report on EC – Hormones , para. 194. 
513 Appellate Body Report on EC – Asbestos , para. 178. 
514 In the letter sent to the experts in relation to the preparation of their written replies, the Panel made 
the following remark: 
 
"In drafting your replies, please remember that the three panelists serving on the case have no 
scientific background and are trying to digest the extensive scientific material submitted by 
the parties with your help.  Therefore, please provide concise  answers which clarify the issues 
at hand and which will eventually assist the Pane l in reaching its legal findings." (Emphasis in 
the original) 
 
Likewise, at the outset of the meeting with the experts, the Chairman mentioned the 
following: 
 
"Last but not least, I would lik e to recall that the Panel members do NOT have scientific 
expertise.  Therefore, I would like to ask the experts to bear this in mind in replying to 
questions and explain issues in layman's terms, providing information on underlying concepts 
as necessary.  In order to get a clearer pictur e with respect to each of the six hormones at 
issue, I would also like to invite all those taking the floor to clarify which of the six hormones their question or reply applies to."   
  WT/DS321/R 
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  However, as already mentioned, we disregarded t hose comments that attempted to put into question 
the objectivity of specific experts.  We believe that  such questions had to be dealt with separately.515  
7.412  We also recall that we are expected to make  findings with respect to each of the hormones 
concerned. Indeed, in Japan – Apples , the Appellate Body recalled th at findings should be made for 
each precise agent that may possibly cause the harm  (in this case each of the hormones concerned): 
"Under the SPS Agreement , the obligation to conduct an assessment of 'risk' is not 
satisfied merely by a general discussion of the disease sought to be avoided by the 
imposition of a phytosanitary measure. The Appellate Body found the risk assessment 
at issue in EC — Hormones  not to be 'sufficiently speci fic' even though the scientific 
Articles cited by the importing Member had evaluated the 'carcinogenic potential of 
entire categories  of hormones, or of the hormones at issue in general .' In order to 
constitute a 'risk assessment' as defined in the SPS Agreement , the Appellate Body 
concluded, the risk assessment should have  reviewed the carcinogenic potential, not 
of the relevant hormones in general, but of  'residues of those hormones found in meat 
derived from cattle to which the hormones had been administered for growth 
promotion purposes'. Therefore, when discussi ng the risk to be specified in the risk 
assessment in EC – Hormones , the Appellate Body referre d in general to the harm 
concerned (cancer or genetic damage) as well as  to the precise agent that may 
possibly cause the harm (that is, the speci fic hormones when used in a specific 
manner and for specific purposes)."516 
7.413  We will therefore address the compatibility of the EC implementing measure with respect to 
each hormone concerned, as appropriate.  However, in  situations where, for instance, information and 
evidence are similar for all hormones, or where in formation was not provided for each hormone in 
spite of our insistence, specific issues are addr essed with respect to th e hormones concerned as a 
whole. 
7.414  There is another question raised in these pro ceedings which the Panel believes it must address 
at this stage.  It is the issue of "old" versus "n ew" evidence, data or studies.  Indeed, the European 
Communities relied extensively on the date of the evidence relied upon by JECFA to support its view 
that the risk assessments performed by JECFA ar e outdated and the ensuing recommendations of 
Codex  unreliable. 
7.415  In its submissions before the Panel and during the hearing with the scientific experts, the 
European Communities contested the validity of JECFA's findings517 on the basis that it had relied in 
its assessments on studies that dated back to th e 1960s, 1970s and 1980s. The Panel sought the views 
of the experts on this point.518  Dr.  Boisseau pointed out that "It is  just a banality to say that JECFA is 
provided with new data when it is requested to assess veterinary drugs recently placed on the market and older data in the case of veterinary drugs alr eady marketed since a long time ago.  Anyway, the 
quality and the number of the available data are more  important than the dates at which these data 
have been produced."
519  
7.416  During the hearing with the experts, the Eur opean Communities sought the view of Dr. De 
Brabander as to whether the validity of "old" data  from the 1970s and 1980s should be put in doubt 
                                                      
515 See Section V II.A.2(c) above. 
516 Appellate Body Report on Japan – Apples , para. 202 (original footnotes omitted). 
517 For a comprehensive list and explanation of JECFA's risk assessment on the six hormones 
concerned, see Annex E-2, JECFA's reply to Panel question 17, as well as Exhibit CDA-32. 
518 See questions 34 and 35 of the Panel to the scientific experts, Annex D. 
519 Reply of Dr. Boisseau to question 35 of the Panel, Annex D. WT/DS321/R 
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  because they are old and they have been measured with measurement methods which, it argues, are by 
today's standards not credible, are not accurate, because there are new, more powerful and more 
accurate analytical methods.520  Dr. De Babander replied: "[t]hat is  my conclusion.  I cannot say that 
the data are bad, I don't say that, I just say you don't know that they are good."521 
7.417  During the same hearing, Dr. Wennberg specified  that: "... even if [the studies used by 
JECFA] were older [than the 1970s], if the methodology that was used, and if the methods had been 
validated properly, there is no reason to discred it any studies because they were done a long time 
ago."522  Dr. Boisseau added that: 
"What the Commission said is true as regards the results that are at the level of the 
limits of detection of the methods previous ly used.  But once the results obtained are 
clearly over the limits of detection, what counts is the precision of the method and its 
reproducibility.  The fact that the method used to provide these results is old is irrelevant to the extent that they have b een validated.  Indeed, we need only concern 
ourselves with the uncertainty that we may ha ve regarding the very low values at the 
level of the limits of detection."
523  
7.418  The Panel first notes that the experts agree that  data do not become invalid only because they 
are old, but that more recent measurement or an alytical methods may be more accurate.  The Panel 
notes, however, that a problem related to accuracy is lik ely to occur with respect to results at the level 
of the detection limits of the older methods. Outside th is particular situation, what matters is whether 
the method has been validated. The Panel thus concludes that whether a study is old or not is not per 
se a criterion to put in doubt the validity of this study. 
(iv) Whether the EC implementing measure is an SPS measure 
7.419  Before the Panel can determine whether the EC ban is consistent with the SPS Agreement , we 
must first determine whether the measur e is subject to the disciplines of the SPS Agreement , i.e. 
whether the measure is an SPS measure.  In order to determine whether the ban is an SPS measure, 
the Panel will determine whether the measure fits with in the definition of an SPS measure set forth in 
Annex A(1) of the SPS Agreement .524 
                                                      
520 Transcript of the Panel meeting with the experts, Annex G, para. 674. 
521 Transcript of the Panel meeting with the experts, Annex G, para. 675. 
522 Transcript of the Panel meeting with the experts, Annex G, para. 651. 
523 Transcript of the Panel meeting with the experts, Annex G, para. 679. 
524 Article 1 of the SPS Agreement  reads as follows: 
 
"General Provisions 
 
1. This Agreement applies to all sanitary and phytosanitary measures which may, 
directly or indirectly, affect international trade.   Such measures shall be developed and applied 
in accordance with the provi sions of this Agreement. 
 
2. For the purposes of this Agreement, the definitions provided in Annex A shall apply.   
 
3. The annexes are an integral  part of this Agreement. 
 
4. Nothing in this Agreement shall affect the rights of Member s under the Agreement 
on Technical Barriers to Trade with respect to measures not within the scope of this 
Agreement." 
 
Annex A, paragraph 1, to the SPS Agreement  reads as follows:  WT/DS321/R 
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  7.420  As the panel in EC – Approval and Marketing of Biotech Products  explained, in determining 
whether a measure is an SPS measure, regard must be had to such elements as the purpose of the 
measure, its legal form and its nature.  The purpo se element is addressed in Annex A(1)(a) through (d) 
("any measure applied to"). The form element is referred to in the second paragraph of Annex A(1) 
("laws, decrees, regulations"). Finally, the natu re of measures qualifying as SPS measures is also 
addressed in the second paragraph of Annex A(1) ("re quirements and procedures, including, inter alia, 
end product criteria; processes and production methods; testing, insp ection, certification and approval 
procedures; [etc.]").  The Panel will address each element hereafter. 
7.421  The European Communities explained in Directive 2003/74/EC that the purpose of the ban on 
the six hormones at issue is to prevent meat and meat products from cattle tr eated with such hormones 
for growth promotion purposes from being placed on the EC market.525  The Panel notes that 
Annex A(1)(b) defines an SPS measure as any measur e applied "to protect human or animal life or 
health within the territory of the Member from ri sks arising from additives, contaminants, toxins or 
disease-causing organisms in foods, beverages or feedstuffs."   
7.422  Consistent with the Panel in EC– Approval and Marketing of Biotech Products  we consider 
that a substance which a human be ing or an animal consumes for nut ritional reasons may be classified 
as a "food".526  The Panel also takes notice of the foot note to Annex A, which specifically defines 
"contaminants" as including veterinary drug residues,  such as the residues of the hormones which are 
the subject of the EC measure. 
                                                                                                                                                                     
 
DEFINITIONS [footnote 4] 
 
"1. Sanitary or phytosanitary measure – Any measure applied: 
 
(a) to protect animal or plant life or health within the territory of the Member from risks 
arising from the entry, establishment or spread  of pests, diseases, disease-carrying organisms 
or disease-causing organisms;   
 
(b) to protect human or animal life or hea lth within the territory of the Member from 
risks arising from additives, contaminants, toxi ns or disease-causing organisms in foods, 
beverages or feedstuffs;   
 
(c) to protect human life or health within the territory of the  Member from risks arising 
from diseases carried by animals,  plants or products thereof, or  from the entry, establishment 
or spread of pests;  or 
 
(d) to prevent or limit other damage within th e territory of the  Me mber from the entry, 
establishment or spread of pests.   
Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, 
requirements and procedures including, inte r alia, end product criteria;  processes and 
production methods;  testing, inspection, cer tification and approval procedures;  quarantine 
treatments including relevant requirements associ ated with the transport of animals or plants, 
or with the materials necessary for their survival during tran sport;  provisions on relevant 
statistical methods, sampling procedures and methods of risk assessment;  and packaging and 
labelling requirements directly related to food safety."   
 
Footnote 4 to Annex A reads as follows: 
 "For the purpose of these definitions, "animal" includes fish and wild fauna; "plant" includes forests 
and wild flora; "pests" include weed s; and "contaminants" include pesticide and veterinary drug residues and 
extraneous matter." 
525 Directive 2003/74/EC, Article 1. 
526 Panel Report on EC – Approval and Marketing of Biotech Products , paras. 7.291-7.292. WT/DS321/R 
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  7.423  Comparing the definition of an SPS measure in A nnex A(1)(b) to the stated purpose of the EC 
ban on the hormones at issue, the Panel concludes th at the purpose of the EC measure is that of an 
SPS measure within the meaning of Annex A(1)(b) of the SPS Agreement . 
7.424  The second paragraph of Annex A states that sanitary or phytosanitary measures include all 
relevant laws, decrees and regulations  as well as requirements and procedures.527  In this instance, the 
EC measure is a directive adopted by the Council of  the European Union and the European Parliament 
which was published in the Official Journal of th e European Communities.  Therefore, this Panel 
finds that the measure in question is included within the phrase "all relevant laws, decrees, 
regulations ..."  as used in Annex A of the SPS Agreement .  This Panel also agrees with the panel in 
EC– Approval and Marketing of Biotech Products  that a ban may be considered as a "requirement" 
within the meaning of the second paragraph of Annex A to the SPS Agreement .528  Therefore, this 
Panel finds that the EC measure constitutes such a "requirement". 
7.425  In conclusion, because the EC Directive 2003/74/EC was adopted for the purpose of 
protecting human life from contaminants in food and takes the form and nature contemplated in the 
second paragraph of Annex A, this Panel finds that the EC Directive 2003/74/EC is an SPS measure 
within the meaning of Annex A(1)(b) and the second paragraph of Annex A. 
(e) Compatibility of the EC implementing measure with Article 5.1 of the SPS Agreement  with 
respect to oestradiol-17 β  
(i) Introduction 
7.426  The Panel notes that the European Communiti es has asserted that it adopted the Directive 
banning the placing on the market of meat and meat  products from cattle trea ted with oestradiol-17 β 
for growth promotion purposes based on a risk assessm ent conducted by the SCVPH consistent with 
Article 5.1 of the SPS Agreement . 
7.427  Specifically, the European Communities states that  in order to comply with the rulings and 
recommendations of the DSB in the EC – Hormones  dispute, it conducted a comprehensive risk 
assessment, which focused on potential risks to human  health from hormone residues in bovine meat 
and meat products.529  The European Communities also ass erts that Directive 2003/74/EC, which 
provides for a permanent ban on meat and meat pro ducts from animals treated for growth promotion 
purposes with oestradiol-17 β, is based on the above referenced risk assessment.530   
7.428  We note that the DSB found in the EC – Hormones  dispute that the ban on meat and meat 
products from cattle treated with the six hormones for growth promotion purposes, according to good 
veterinary practice ("GVP"), was inconsistent with Article 5.1 of the SPS Agreement  because it was 
not based on a risk assessment with in the meaning of that Article.   In this case, the European 
Communities has asserted that it has removed that inconsistency with respect to oestradiol-17 β by 
conducting a comprehensive risk assessment and basing its implementing measure on that risk 
assessment so that the measure is now consistent with Article 5.1 of the SPS Agreement .  We also 
recall that, unlike the United States in dispute WT/DS320, Canada has not argued that the EC definitive ban on oestradiol-17 β breaches Article 5.2 of the SPS Agreement,  but only that it breaches 
                                                     
 
527 "Including inter alia end product criteria; processes and production methods;  testing, inspection, 
certification and approval procedures;  quarantine treatments including releva nt requirements associated with 
the transport of animals or pl ants, or with the materials necessary for their survival during transport;  provisions 
on relevant statistical methods, sampling procedures an d methods of risk assessment;  and packaging and 
labelling requirements directly related to food safety." 
528 Panel Report on EC – Approval and Marketing of Biotech Products , para. 7.1334. 
529 EC's first written submission, para. 143. 
530 EC's first written submission, para. 146.  WT/DS321/R 
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  Article 5.1.   Therefore, as mentioned above, the Panel cons iders that it should limit its review of the 
conformity of the EC implementing measure to Article 5.1 of the SPS Agreement .   
7.429  Article 5.1 of the SPS Agreement  reads as follows: 
"Members shall ensure that their sanitary or phytosanitary measures are based on an 
assessment, as appropriate to the circumstances, of the risks to human, animal or 
plant life or health, taking into account risk assessment techniques developed by the 
relevant international organizations."  
7.430  An analysis under Article 5.1 consists of tw o fundamental questions.  First, was a risk 
assessment, appropriate to the circumstances a nd taking into account risk assessment techniques 
developed by the relevant intern ational organizations conducted?  Second, is the sanitary measure 
based on that risk assessment?  The Pa nel will address each question successively. 
(ii) Is there a risk assessment within the meaning  of Article 5.1 of the SPS Agreement?   
7.431  In assessing whether a measure is based on a risk assessment within the meaning of 
Article 5.1 of the SPS Agreement, the Panel must first determine whether a risk assessment was 
conducted at all.  The Panel is aware that the Appellate Body in EC – Hormones determined that 
"Article 5.1 does not insist that a Member that adopts a sanitary measure sh all have carried out its 
own risk assessment …  The SPS measure might we ll find its objective justification in a risk 
assessment carried out by another Member, or an international organization".531  In the present case, 
the European Communities has asserte d that the three Opinions produced by the SCVPH, an organ of 
the European Communities, constitute the required ri sk assessment.  Therefore,  the task before the 
Panel is to determine whether the European Communities conducted a risk assessment within the 
meaning of Article 5.1 of the SPS Agreement . 
7.432  To determine whether the Opinions constitute a risk assessment, the Panel must measure the 
European Communities' actions ag ainst the requirements of the SPS Agreement .  The Panel recalls 
that it is not the appropriate role of the Panel to conduct its own risk assessment based on scientific 
evidence gathered by the Panel or submitted by the parties during the Panel proceedings.532  Similarly, 
the Panel believes that it is not its role to  impose any scientific opinion on the European 
Communities.533  The Panel must objectively measure the Op inions against the relevant standard for 
whether a risk assessment has been conducted, which can be found in the texts of Article 5.1 as well 
as Annex A(4) of the SPS Agreement.  Therefore, we examined and evaluated the evidence – 
including the information received from the experts advising the Panel – and the arguments put before 
us in light of the relevant WTO provisions and based our conclusions on this evidence and these 
arguments.534 
7.433  The text of Article 5.1 requires that in the assessment of risks the Members take into account 
risk assessment techniques developed by the releva nt international organi zations.  Article 5.2, 
likewise, prescribes several factors that a Member must take into account when making its assessment 
of the risks.  Additionally, Annex A(4) provides a definition of what constitutes a risk assessment.  
                                                      
531 Appellate Body Report on EC – Hormones , para. 190, followed in the Panel Report on EC – 
Approval and Marketing of Biotech Products , para. 7.3024. 
532 Panel Report on EC – Hormones (Canada) , para. 8.104; Panel Report on EC – Hormones  (US) , 
para. 8.101. 
533 Panel Report on Australia – Salmon , para. 8.41.  A similar statement was made by the Panel on 
Japan – Agricultural Products II , in para. 8.32. 
534 Panel Report on Australia – Salmon , para. 8.41.  A similar statement was made by the Panel on 
Japan – Agricultural Products II , in para. 8.42. WT/DS321/R 
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  Finally, as the Panel and Appellate Body explained in Japan – Apples,  for a risk assessment to be 
valid the science evaluated must support the conclusions reached in the risk assessment.535  
7.434  The European Communities asserts that the 1999, 2000, and 2002 Opinions constitute its risk 
assessment for oestradiol-17 β.  Therefore, in determining whethe r these Opinions are indeed a risk 
assessment as appropriate to the circumstances,  within the meaning of Article 5.1 of the 
SPS Agreement , the Panel will examine whether the Opin ions (1) took into account risk assessment 
techniques of the relevant international organizations ; (2) satisfied the definition in Annex A(4) and: 
(3) whether the conclusions in the Opinions are supported by the scientific evidence evaluated. 
Do the Opinions take into account risk assessm ent techniques of the relevant international 
organizations?  
Introduction 
7.435  Article 5.1 includes the proviso that Members,  when developing sanitary and phytosanitary 
measures based on risk assessments, take into acco unt risk assessment techniques developed by the 
relevant international organizations.  The SPS Agreement  does not specifically identify the relevant 
international organizations for purposes of Artic le 5.1.  However, the Preamble of the SPS Agreement  
speaks of harmonization and recomme ndations developed by the releva nt international organizations, 
including the Codex Alimentarius Commission (Code x).  Additionally, Annex A(3) states that for 
food safety the standards, guidelines and recommenda tions established by the Codex Alimentarius 
Commission (Codex) relating to food additives, veteri nary drug and pesticide residues, contaminants, 
methods of analysis and sampling, and codes and guidelines of hygienic practice will constitute 
international standards, guidelines, and recommendations within the meaning of the SPS Agreement .  
Article 3.2 states that SPS measures which conform to  the above referenced standards are deemed to 
be necessary to protect human, animal, or plant life or  health and are presumed to be consistent with 
the SPS Agreement  and GATT 1994 .  Moreover, Article 3.4 of the SPS Agreement requires Members 
to participate fully in Codex work, within the limits  of their resources.  After an examination of these 
provisions of the SPS Agreement  and the context of Article 5.1 as part of the process for adopting SPS 
measures which are consistent with the SPS Agreement , the Panel concludes that the Codex 
Alimentarius Commission constitutes a "relevant inte rnational organization" within the meaning of 
Article 5.1.  
7.436  The parties in this dispute as well as the experts have made significant references to JECFA's 
work.  JECFA, while officially not part of the C odex structure, provides independent scientific expert 
advice to the Codex Alimentarius Commission and its specialist Committees.  JECFA conducts risk 
assessments on various substances, establishes ADIs536 where appropriate, and in the case of residues 
of veterinary drugs in foods, recommends MRLs537 for consideration by the Codex Committee on 
                                                      
535 This is not to say, as already recalled above, th at a risk assessment cannot be based on a minority 
opinion of the scientists.  A risk assessment can be base d on a minority opinion which is supported by sufficient 
scientific evidence.  See Appellate Body Report on EC-Hormones , para. 194; and Panel Report on EC – 
Approval and Marketing of Biotech Products , para. 7.3240. 
536 The Codex Committee on Residues of Veterinary Drugs in Foods defines an Acceptable Daily 
Intake (ADI) as "[a]n estimate by JECFA of the amount of a veterinary drug, expressed on a body weight basis, 
that can be ingested daily over a lifetime without appreciab le health risk (standard man = 60 kg)."  Glossary of 
Terms and Definition (CAC/MISC 5-1993).  The "Glossary of Terms and Definition" has been elaborated by the 
Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) with a view to providing information and guidance to the committee and is intended for internal Codex use only.  (The definition was previously 
established and adopted by JECFA and modified by the Codex Committee on Veterinary Drugs in Foods).  
More information on how ADIs are set is contained in Annex E-2, responses by JECFA to questions 9 and 10. 
537 Codex defines the  maximum limit for residues of veterinary drugs (MRLVD) as the maximum 
concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or μg/kg on a fresh  WT/DS321/R 
 Page 219 
 
 
  Residues of Veterinary Drugs in Foods (CCRVDF). The MRLs adopted by Codex with respect to 
oestradiol-17 β and four of the other five hormones538 are based on the recommendations of JECFA.  
Therefore, this Panel believes that the risk assessme nt techniques of JECFA are also relevant to an 
analysis of compliance with Article 5.1.    
7.437  Codex and JECFA have develope d definitions of the relevant phases of a risk assessment as 
well as guidelines and practices for conducting a risk assessment.539  The European Communities 
indicated in the 1999 Opinion, that the accepted de finition of a risk assessment, as used by both 
Codex and JECFA, is an assessment which is "str uctured to address independently the intrinsic 
properties of the compound under consideration (hazard identification), the evaluation of the nature of 
effects in terms of a dose-response relationship (hazard characterization), the estimate of the dose/concentration of a compound in a daily diet (exposure assessment) resulti ng in the assessment of 
the incidence and severity of potential adverse effects."
540  In its Procedural Manual, Codex defines 
the four phases of risk assessment as follows: 
(a) hazard identification : The identification of biological , chemical, and physical agents 
capable of causing adverse health effects and which may be present in a particular 
food or group of foods. 
(b) hazard characterization :  The qualitative and/or quantitative evaluation of the nature 
of the adverse health effects associated with  biological, chemical, and physical agents 
which may be present in food.  For ch emical agents, a do se-response assessment541 
should be performed.  For biological or physical agents, a do se-response assessment 
should be performed if the data are obtainable. 
                                                                                                                                                                     
weight basis) that is recommended by the Codex Alimentarius Commission to be legally permitted or 
recognized as acceptable in or on a food.  
 
It is based on the type and amount of residue considered to be without any toxicological hazard for 
human health as expressed by the Acce ptable Daily Intake (ADI), or on the basis of a temporary ADI that 
utilizes an additional safety factor. It also takes into acco unt other relevant public health risks as well as food 
technological aspects.  
 When establishing an MRL, consideration is also given to residues that occur in food of plant origin 
and/or the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use 
of veterinary drugs and to the extent that practical analytical methods are available.  From: Definitions for the 
Purposes of the Codex Alimentarius, Codex Alimentarius Commission Procedural Manual (15
th Edition), FAO 
and WHO, 2006, page 43.  More information on how MRLs are set is contained in Annexes E-1 and E-2, 
responses by Codex and JECFA to questions 9 and 10. 
538Progesterone, testosterone, zera nol and trenbolone acetate. 
(http://www.codexalimentarius.net/mrls/vetdrugs/jsp/vetd_q-e.jsp). 
539 In response to the Panel's questions regarding international guidance documents for conducting a 
risk assessment, in particular with respect to veterinary  drug residues, the representative of Codex and JECFA as 
well as the experts referred to a variety of documents from the  Codex Alimentarius Commission, JECFA, the 
World Health Organization, the Food and Agriculture Organization, and other scientific bodies, see Responses 
of the Codex Alimentarius Commission and JECFA to Panel Questions 3 and 4, Annexes E-1 and E-2 
respectively and replies by the scientific experts to Panel questions, Annex D, paras. 62-71. 
540 1999 Opinion, page 70, Exhibit CDA-2. 
541 Codex defines a dose-response assessment as the determination of the relationship between the 
magnitude of exposure (dose) to a chemical, biological, or physical agent and the severity and/or frequency of associated adverse health effects (response).  Codex Alimentarius Commission , Procedural Manual, Fifteenth 
Edition (2005), p. 45. WT/DS321/R 
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  (c) exposure assessment :  The qualitative and/or quantitative evaluation of the likely 
intake of biological, chemical, or physical agents via food as well as exposures from 
other sources if relevant. 
(d) risk characterization :  The qualitative and/or quantitative estimation, including 
attendant uncertainties, of the probabilit y of occurrence and severity of known 
potential adverse health effects in a give n population based on hazard identification, 
hazard characterization, and exposure assessment.542   
7.438  Although Codex and JECFA base their relevant work on some general principles and the 
definitions of a risk assessment stated above and JECFA relies on a variety of guidance documents on 
how to conduct a risk assessment with respect to  veterinary drug residues in food, the experts 
confirmed that no specific "techniques" or guidelines had thus far  been adopted by Codex for use by 
national governments in conducting risk assessments of veterinary drug residues.543 
Summary of the main arguments of the parties544 
7.439  Canada  argues that, while the requirement of Artic le 5.1 that the risk assessment relied upon 
by the European Communities "tak [e] into account risk assessment techniques developed by the 
relevant international organizati ons" does not amount to an obligation to conduct a risk assessment 
according to these techniques, an evaluation of the purported risk assessment according to these 
techniques provides context and guidance to the more general test elaborated by the Appellate Body 
in EC – Hormones . Canada disagrees with the EC claim that  the Opinions followed these techniques. 
7.440  Canada challenges the EC claim that a positive relationship between genotoxicity and the 
incidence of tumours may alter the approach taken in  a risk assessment.  Canada argues that this does 
not grant the European Communities licence to avoid completely the requirement that its measure be 
based on a valid risk assessment.   
7.441  Canada also challenges the EC claim that da ta are unavailable to allow it to conduct an 
exposure assessment, noting that the scientific studi es commissioned by the European Communities in 
fact generated exposure da ta.  Canada notes that, in any event, other reputable scientific bodies have 
conducted complete assessments of risks from residues of the hormones at issue in meat from treated 
animals, dealing with both the issue of "non-li near situations" and that of exposure, without 
encountering the limitations expressed  by the European Communities. 
7.442  According to Canada, one furthe r shortcoming of the SCVPH's hazard characterization is that 
it fails to conduct a dose-response assessment. Th e reasons provided by the SCVPH are that no 
threshold level can be established for genotoxic metabo lites in meat and additionally that no threshold 
level can be established for "any of the horm onally active compounds and metabolites which might 
exert endocrinal, developmenta l and neurobiological, immunological or immunotoxicological 
effects." However, it is widely, if not universally , accepted that adverse effects arising from hormonal 
activity are dose-dependent.  Canada argues that the SCVPH provides no justification for why this 
generally-accepted understanding of  the dose-response relationship of  hormonally active substances 
should be rejected a priori in these circumstance s, such that it considers it unnecessary to conduct a 
dose-response assessment.  Furthermore, while intern ational risk assessment techniques suggest that a 
                                                      
542 Ibid. 
543 At its 30th session in July 2007, the Codex Alimentarius Commission adopted "Working Principles 
for Risk Analysis for Food Safety for Application by Governments". 
544 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel.  WT/DS321/R 
 Page 221 
 
 
  dose-response assessment is optional for biological or physical agents when the data cannot be 
obtained, a dose-response assessment should always be conducted for chemical agents, as is the case 
with the hormones at issue here.  
7.443  Canada adds that, in any event, the obligati on on the European Communities is to base its 
measure on a risk assessment that complies with the requirement under the SPS Agreement  to evaluate 
the potential occurrence of adverse effects. In th is respect, Canada considers that the European 
Communities misinterprets the Appellate Body's findings that a risk assessment under the 
SPS Agreement  need not identify a minimum, quantifiable magnitude of risk by suggesting that it 
need not conduct quantitative analysis at any stage of  the risk assessment.  While the Appellate Body 
in EC – Hormones  did find that the evaluation of the potentia l occurrence of adverse effects (that is, at 
the risk characterization stage) could be qualitativ e or quantitative, it went on to find that such 
evaluation still needs to be a pr ocess characterized by systematic, disciplined and objective enquiry 
and analysis.545  
7.444  The European Communities  agrees that the risk assessment techniques developed by Codex 
are relevant and contemplated in Article 5.1's re quirement to take into account the risk assessment 
techniques developed by relevant  international organizations.546  
7.445  In this respect, the European Communities main tains that its Opinions take into account the 
conventional risk assessment techniques in addition to other factors that are expressly permissible 
under the definition of a risk assessment in Article 5.1.547  The European Comm unities argues that it 
went beyond the international standards for a risk assessment to consider "real life" situations as 
contemplated by the Appellate Body's ruling in EC – Hormones.   
7.446  The European Communities argues that the ri sk assessment at the basis of Directive 
2003/74/EC precisely follows the four steps of risk  assessment as defined by Codex, enabling it to 
identify different levels of risks presented by differe nt uses, and that this Directive then adapts the 
management of these risks accordingly.548  However, the European Communities also notes that the 
Codex approach has serious limitations in non-lin ear situations, such as with regard to these 
hormones.  The European Communities argues that  the currently available Codex guidance poorly 
addresses cases such as this wher e the risks are embedded in cha nges in exposure to biologically 
active molecules which may, with minute differences in  their bioavailability, ha ve dramatic effects, 
such as turning on or off complete developmen tal programmes of the human genome, or inducing 
pathological conditions.549 
7.447  Specifically, the European Communities argued th at with hormones that are also produced 
endogenously when you add more of the same ki nd of hormone, such as oestrogen, you are just 
increasing the response that is already taking place, a nd in that case there cannot be a threshold.  The 
threshold has already been exceeded by the concentrati on of hormones in circulation.  So this specific 
                                                      
545 Canada's second written submission, para. 81. 
546 EC's replies to Panel questions after the first substantive meeting, question 24, Annex B-1. 
547 1999 Opinion, p.2  (citing Appellate Body Report on EC – Hormones  for the premise that the risk to 
be evaluated is "not only risk ascertainable in a labo ratory operating under strictly controlled conditions, but 
also risk in human societies as they actually exist, in  other words the actual potential for adverse effects in 
human health in the real world wh ere people live and work and die.") 
548 EC's replies to Panel questions after the first substantive meeting, question. 24, Annex B-1, 
para. 142. 
549 EC's replies to Panel questions after the first substantive meeting,, question 24, Annex B-1, 
para. 140. WT/DS321/R 
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  set of conditions results in dose-response curves th at will have no threshold, and if there is no 
threshold, there is no safe dose, unlike the sugg estion that there is an acceptable daily intake.550   
7.448  The European Communities asserts that it is ge nerally recognized that for substances which 
have genotoxic potential (as is the case with oestradiol-17 β) a threshold cannot be identified.  This 
would mean that there is no level below which inta kes from residues should be considered to be safe.  
The fact that the doses used in growth promotion are low is not of relevance. 551  Therefore, the 
European Communities argues that it was not requi red to do a quantitative evaluation of the dose-
response.552 
7.449  With respect to Canada's arguments regarding id entification of adverse effect, particularly  
Canada's argument that the new risk assessment of  the European communities is not specific enough, 
the European Communities argues these argument s are based on outdated data from Canada and 
JECFA.  The European Communities adds that Canada misinterprets the findings of the latest 
scientific evidence, including that generated by the 17 EC studies.  
7.450  To Canada's argument that the findings of the SCVPH are not specific to residues in meat, the 
European Communities responds that the 1999 and 2002 Opinions of the SCVPH have a specific 
chapter for each of the six hor mones about the dose-response question and the potential risks from 
residues in meat from animals treated w ith these hormones for growth promotion.553 The European 
Communities notes that even JECF A has declared oestradiol-17 β for the first time in 1999 to have 
"genotoxic potential", which means that there is  normally no safe threshold for any amount of 
residues in meat from this hormone. So the issue of specificity for this hormone becomes irrelevant.  
7.451  The European Communities further argues that Ca nada's argument that the SCVHP failed to 
complete the second step of the risk assessment in that its opinions do not evaluate the potential 
occurrence of the adverse effects they purport to id entify is incorrect.  Indeed, this refers to the 
exposure of consumers to hormones originating from th e treatment of animals. Th is is referred to in 
the Opinions in several points.554 
Reasoning of the Panel 
7.452  In determining whether the European Comm unities took into account the risk assessment 
techniques of the relevant international organizati ons in the Opinions, the Panel requested that the 
experts evaluate the Opinions in light of th e Codex definitions, guidelines, and practices. 
7.453  The experts who answered the Panel's question on this issue concluded that the Opinions were 
not entirely consistent with the C odex guidelines and definitions.   
7.454  Dr. Guttenplan pointed out that the Eur opean Communities had done a thorough hazard 
identification, but that its hazard characterization was limited and that the extrapolation of the one 
animal model study from hamster kidney to humans  was uncertain.  He noted that the European 
Communities also relied on older studies with no re ports of replication and had no epidemiological 
studies comparing cancer incidence or prevalence in populations consuming hormone-treated or 
untreated meat.555  Dr. Boobis stated that the European Communities had not identified the potential 
for adverse effects on human health of residues of o estradiol found in meat from treated cattle.  This 
                                                      
550 Transcript of the Panel meeting with the experts, Annex G, para. 252. 
551 EC's second written submission, paras. 201-202. 
552 EC's second written submission, para. 200. 
553 See section 4.1.5 for oestradiol, section 4.2.4. for testosterone, section 4.3.4. for progesterone, 
section 4.4.4. for trenbolone acetate,  section 4.5.4. for zeranol, and s ection 4.6.4. for melengestrol acetate. 
554 EC's second written submission, paras. 115-127. 
555 Replies by the scientific experts to Panel question 14, Annex D, para. 149.  WT/DS321/R 
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  was because the analysis undertaken  was focused primarily on hazard identification.  There was little 
in the way of hazard characterization, and no i ndependent exposure assessment was undertaken.  
Dr. Boobis stated that because no adequate exposur e assessment was undertaken  it was not possible to 
complete the risk characterization phase of the assessment.556  In sum, Dr. Boobis concluded that the 
European Communities' risk assessment  of oestradiol did not follow the four steps of the Codex risk 
assessment paradigm.557  
7.455  Dr. Boobis indicates in his written replies that a "hazard-based" approach, which is making 
recommendations as to potential safety based on intr insic capacity to cause harm rather than on the 
probability of harm occurring is most commonly used for substances that are genotoxic or have 
genotoxic potential, although not all such substances would be treated this way.558  Dr. Boobis further 
explained the "hazard-based" approach at the meeti ng with the Panel where he stated that if, for 
example, a compound is shown to be a direct-acting genotoxicant, this is considered unacceptable at 
any level of exposure.  As pe rmitting exposure would not be appropriate, one stops the risk 
assessment at that point.  It does not need to ta ke account of exposure, because any level of exposure 
is deemed to be of concern.559  Dr. Cogliano agrees that there have been cases where calling 
something a carcinogenic hazard has led an agency to make a decision just on the qualitative element 
alone. 560  However, Dr. Tritscher, the representative of  JECFA maintains that a hazard identification 
is not a risk assessment; a risk assessment comprises the four steps.561 
7.456   Both Drs. Cogliano and Boobis explain that the issue of thresholds and whether an 
acceptable daily intake can be established and all f our steps of a risk assessment as defined by Codex 
can be conducted has to do with the assumptions a nd interpretations that the scientists conducting the 
risk assessment are willing to make.562 
7.457  Although there was considerable debate among th e parties and the experts advising the Panel 
about whether the European Communities followed a ll four steps of a risk assessment as defined by 
Codex or indeed whether it was even necessary to  do so in the case of a substance such as  
oestradiol-17 β, the Panel must concur  with the reasoning of the panel in Japan – Apples , that the 
requirement to "take into account" the risk assess ment techniques of international organizations:  
"[D]oes not impose that a risk assessment under Article 5.1 be 'based on' or 'in 
conformity with' such risk assessment techni ques.  This suggests that such techniques 
should be considered relevant, but that a fa ilure to respect each  and every aspect of 
them would not necessarily, per se , signal that the risk assessment on which the 
measure is based is not in conformity with the requirements of Article 5.1."563  
7.458  This means that although the risk assessment techniques of Codex and JECFA are relevant 
and must be considered by the risk assessor, compliance with Codex or JECFA risk assessment 
techniques is not required by the SPS Agreement .  What is required is that the risk assessor take those 
techniques into account and that it comply with th e other requirements of Article 5 and Annex A of 
the SPS Agreement  with respect to conducting a risk assessment. 
7.459  It is undisputed that the European Communities was aware of the Codex and JECFA 
guidelines and considered them in the preparation of  the Opinions.  Therefore, the Panel concludes 
                                                      
556 Replies by the scientific experts to Panel question 13, Annex D, para. 144. 
557 Replies by the scientific experts to Panel question 14, Annex D, para. 148. 
558 Replies by the scientific experts to Panel question 36, Annex D, paras. 310-311. 
559 Transcript of the Panel meeting with the experts, Annex G, para. 385. 
560 Transcript of the Panel meeting with the experts, Annex G, para. 438. 
561 Transcript of the Panel meeting with the experts, Annex G, para. 453. 
562 Transcript of the Panel meeting with the experts, Annex G, paras. 1021-1027. 
563 Panel Report on Japan – Apples , para. 8.241. WT/DS321/R 
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  that although it may not have strictly followed th em, the European Communities did take into account 
the risk assessment techniques of the relevant in ternational organizations in the conduct of the 
Opinions. 
Do the Opinions satisfy the definition in Annex A(4) of the SPS Agreement ? 
Introduction 
7.460  Annex A(4) defines a risk assessment as: 
"[t]he evaluation of the likelihood of entry, establishment or spread of a pest or 
disease within the territory of an importi ng 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 th e potential for adverse 
effects on human or animal health aris ing from the presence of additives, 
contaminants, toxins or disease-causing or ganisms in food, bever ages or feedstuffs. " 
(Emphasis added) 
7.461  In this dispute, the measure at issue is intende d to protect human health as a sanitary measure 
defined in Annex A(1)(b) and, t hus, is to be based on a risk assessment in the sense of the second 
definition in Annex A(4).564   
Summary of the main arguments of the parties565 
7.462  Canada  argues that the three Opinions do not c onstitute a "risk assessment" for the purposes 
of the SPS Agreement .  The Opinions do not identify any adve rse effects on human health that arise 
from the consumption of meat containing residues of oestradiol-17 β that has been used as a growth 
promotant. The Opinions identify only in a sp eculative fashion potential adverse effects of 
oestradiol-17 β in general, a substance available fro m many sources both en dogenous and exogenous. 
The opinions identify no adverse e ffects arising from oestradiol-17 β when used as a growth 
promotant. 
7.463  According to Canada, none of the potentia l adverse effects identified by the SCVPH, 
however, were said to arise specifically from the consumption of meat containing residues of oestradiol-17 β when used as a growth promotant. In fact, the SCVPH specifically acknowledges on 
several occasions the absence of such a link. Theref ore, as a result of the speculative nature of the 
identification of potential adverse effects in genera l and the absence of a specific link between such 
effects and the use of hormone growth promotants in  particular, the Opinions cannot be seen to satisfy 
the first condition of a "risk assessment". 
7.464  Canada also argues that the SCVPH has further failed to complete the second step in that its 
opinions do not evaluate the potential occurrence of the adverse effects they purport to identify. The 
Opinions simply point to general concerns a bout possible adverse effects of oestradiol-17 β, and do not 
evaluate the potential occurrence of such effects as a result of consumption of meat derived from 
hormone-treated animals. This failure is a functi on of having not sufficiently identified any adverse 
effects from the consumption of meat derive d from animals treated with oestradiol-17 β, making it 
                                                     
 
564 Panel Report on Australia – Salmon , paras. 8.72 and 8.116 (that panel finds that because the 
measure at issue was meant to protect an imal health as a sanitary measure as  defined in Annex A(1)(a), the first 
definition in Annex A(4) applied). 
565 A more detailed account of the parties' arguments can  be found in Section IV the descriptive part of 
this Report.  The order in which the respective argumen ts of the parties are pres ented does not reflect any 
allocation of the burden of proof by the Panel.  WT/DS321/R 
 Page 225 
 
 
  impossible to evaluate the potential that such adve rse effects will occur. More importantly, however, 
the SCVPH has failed to conduct even the minimum steps of such an evaluation. 
7.465  Canada recalls that the Appellate Body found in EC – Hormones  that the scientific evidence 
considered in a risk assessment had to be "sufficiently  specific" to the substance at issue, in this case 
residues of oestradiol-17 β in meat from animals that have been treated with that substance for growth-
promotion purposes. Even for those potential adver se effects that it does identify the SCVPH does not 
evaluate in a manner that is sufficiently specific to  the substances at issue, and as such the SCVPH has 
not completed the second step required of a risk assessment.566 
7.466  The European Communities  argues that the Opinions do cons titute a risk assessment within 
the meaning of Article 5.1 of the SPS Agreement .  Specifically, the European Communities argues 
that there is a difference between a scientific ri sk assessment in the narro w sense referred to by 
Canada and the risk assessment within the mean ing of Article 5.1 and Annex A(4) of the 
SPS Agreement .567 
7.467  The European Communities argues that the Ap pellate Body has confirmed that a risk 
assessment within in 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.568 
7.468  Although the European Communities agrees that in principle the risk resulting from human 
consumption of meat from cattle treated with oestradiol-17 β for growth promotion purposes, 
according to good veterinary practice is the relevant ri sk, it argues that the assessme nt of such a risk is 
qualified by the difficulty in estimating the intake of such hormones.  Specifically, the European 
Communities argues that human beings, including th e populations at risk, are exposed to cumulative 
and synergistic effects, as they may be expo sed to multiple sources of hormones and hormone 
residues, via several intake routes, as well as from endogenous production of some of these hormones.  
The European Communities contends that it is extr emely difficult or impossible to assess accurately 
consumer exposure patterns, or other exposures fro m other environmental or  endogenous sources, but 
it is also virtually impossible to assess all cumulativ e and synergistic effects that may arise from all 
potential exposure patterns, including for simu ltaneous exposure to several of these hormones.569 
7.469  The European Communities argues that the onl y rationale that can be inferred from the 
available scientific data is that the higher the exposure to residues from these hormones, the greater 
the risk is likely to be.570  The European Communities points out that the Opinions noted that the 
DNA-damaging effects of oestrogen indicate that no threshold exists for the risk from oestrogen metabolites.  The Opinions concl uded that, in light of the recent data 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 risk 
related to residues in meat could be presented.
571   
7.470  The European Communities goes on to say that the risk resulting from human consumption of 
meat from cattle treated with oestradiol-17 β for growth promotion purposes, according to good 
veterinary practice, is "assessed in the real worl d" where "people live, work and die", or may be 
suffering from clinical disorders, or may be particularly vulnerable segments of the population ( e.g., 
                                                      
566 Canada's first written submission, paras. 88-100. 
567 EC's second written submission, para.116; EC's re ply to Panel question 24 after the first substantive 
meeting, Annex B-1. 
568 EC's second written submission , para. 116. 
569 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 92-96. 
570 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 94. 
571 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 38. WT/DS321/R 
Page 226 
 
 
  like prepubertal children), etc.572 The European Communities asserts  that it considered in its 
assessment the potential risks resu lting from the actual residues from non-treated as well as treated 
animals for growth promotion, and came to the conc lusion that under realistic conditions of use such 
residues from treated animals for growth promotion do pose a higher risk and that it could not achieve 
the level of protection it has consid ered appropriate in its territory.573 
7.471  The European Communities argues that it is not  necessary to compare the two situations and 
then try to quantify how much one is more risky th an the other and to what measurable level the risk 
is likely to occur, but rather to assess a situa tion of additive risks arising from the cumulative 
exposures of humans to multiple hazards, in additio n to the endogenous production of some of these 
hormones by animals and human beings.574 
7.472  The European Communities contends that eviden ce from both the health risk associated with 
the use of hormones generally and the administration of hormones in animals for growth promotion 
purposes, is relevant for the performance of  a risk assessment in the sense of the SPS Agreement , 
because both sources of evidence impact upon and inform each other.575 
7.473  The European Communities notes that  it is scientifically undisputed that life-time exposure of 
humans to the levels of endogenous production of oestrogen (and in particular to oestradiol-17 β and 
its metabolites) is sufficient to cause and/or promot e cancer in some individuals.  This is frequently 
called risk of cancer from background (endogenous) exposure.  This kind of exposure (and the 
attentive risk of cancer) cannot be avoided.  Th e European Communities also  notes that humans are 
exposed daily to variable levels of residues of oestradiol-17 β from many exogenous sources where 
these hormones naturally occur, which likewise cannot be avoided.576   
7.474  The European Communities argues that "additive risk" refers to exposure which is "further 
added on humans from the levels of residues in meat from animals treated with these hormones for 
growth promotion."  Such exposure leads to a risk of cancer which is "added" to the cancer risk from 
the existing endogenous exposure through the b ackground levels of hormones and through the 
exposure to exogenous sources, such as non-treated na tural food.  The European Communities cites to 
the 2002 US Report on Carcinogenesis and argues that  it agrees with the conclusions in the SCVPH 
Opinions that "veterinary use of steroidal estroge ns to promote growth and treat illness can increase 
estrogens in tissues of food-producing animals to ab ove their normal levels", in general substantially 
higher than the normal (endogenously produced) le vels.  The European Communities argues that 
exposure to residues from hormone-treated meat is  avoidable because these hormones are chemical 
substances that are deliberately added to meat.577 
7.475  The European Communities states in response to the Panel's questions on additive risk: 
"The risk of cancer from the consumption of residues in hormone-treated meat are 
'additive' (to risk of cancer from the two other sources of exposure), irrespective of 
whether these hormones are genotoxic carcinogens or only promote cancer through 
receptor-mediated mechanisms. Indeed, if they cause cancer by direct genotoxic 
action, the addition of such exposure increases the likelihood of the adverse effect to occur. If they act only through receptor-med iated mechanism, the risk from such 
exposure will be again 'additive', when th ey cause the presumed threshold to be 
                                                     
 
572 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 96 
573 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 151. 
574 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para.151. 
575 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 254. 
576 EC's replies to Panel questions after the second substantive meeting, Annex C-1, paras. 48-49. 
577 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 50.  WT/DS321/R 
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  exceeded. The risk assessment  of the European Communities has established that 
oestradiol-17 β is a proven genotoxic carcinogen and that the other two natural 
hormones (testosterone and progesterone) are also suspected to be genotoxic. Moreover, the risk assessment of the Eur opean Communities has also demonstrated 
that the ADIs recommended by JECFA for all these hormones will be exceeded under 
realistic conditions of use of these hormones in the US and Canada. They will also be 
exceeded in any case if the more recent data on the endogenous production of the 
natural hormones by pre-pubertal  children is taken into account."
578  
Reasoning of the Panel 
7.476  In EC – Hormones , with respect to the methodology for a risk assessment under the second 
definition of paragraph 4 of Annex A of the SPS Agreement , the panel stated that "in this dispute, a 
risk assessment carried out in accordance with the SPS Agreement  should (i) identify  the adverse 
effects  on human health (if any) arising from the pr esence of the hormones at issue when used as 
growth promoters in meat or meat products , and (ii) if any such adverse effects exist, evaluate  the 
potential  or probability of occurrence of these effects".579 
7.477  Although the Appellate Body did not disagree with the panel, in its report in EC – Hormones  
it noted "that the Panel's use of 'probability' as an alternative term for 'potential' creates a significant 
concern.  The ordinary meaning of 'potential' relate s 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 Pane l introduces a quantitative dimension to the notion of 
risk."
580  
7.478  In Australia – Salmon,  the Appellate Body further elaborated on the distinction between the 
two standards for risk assessment contained in Anne x A(4) and the need for a substantive distinction 
between the evaluation of "likelihood" in the firs t sentence and the evaluation of "potential" in the 
second sentence.  Specifically, the Appellate Body stated: 
"[w]e note that the first type of risk assessment in paragraph 4 of Annex A is 
substantially different from the second type of risk assessment contained in the same 
paragraph. While the second requires only th e evaluation of the potential for adverse 
effects on human or animal health, the first type of risk assessment demands an 
evaluation of the likelihood  of entry, estab lishment or spread of a disease, and of the 
associated potential biological and economic consequences.  In view of the very 
different language used in paragraph 4 of Annex A for the two types of risk 
assessment, we do not believe that it is correct  to diminish the substantial differences 
between these two types of risk assessments ..."581 
7.479  Therefore, the Panel considers that it is necessar y to clarify what constitutes a risk assessment 
as defined by Annex A(4), second sentence.  The Pane l considers that Annex A(4) requires a Member 
to (a) identify the additives, cont aminants, toxins or disease-causing organisms in food, beverages or 
feedstuffs at issue (if any); (b) identify any possibl e 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 organi sms in food, beverages or feedstuffs.   
                                                      
578 EC's replies to Panel questions EC's replies to Panel questions after the second substantive meeting, 
Annex C-1, para. 51. 
579 Panel Report on EC – Hormones  (Canada) , para. 8.101; Panel Report on EC – Hormones  (US) , 
para. 8.98. 
580 Appellate Body Report on EC – Hormones , para. 184. 
581 Appellate Body Report on Australia – Salmon , footnote 69. WT/DS321/R 
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  7.480  The Panel concludes that the European Commun ities has satisfied the first requirement of 
Annex A(4) second sentence, in that it has identified the contaminant and food at issue; namely meat 
and meat products from cattle treated with oestradiol-17 β for growth promotion purposes.  The 
European Communities has also id entified the possible adverse effects on human or animal health, 
namely neurobiological, developmental, reproduc tive and immunological effects, as well as 
immunotoxicity, genotoxicity, and carcinogenicity.582 
7.481  The Panel must now evaluate whether it has satisfi ed the third requirement of the definition of 
a risk assessment.  To do so, the Panel needs to define the terms "potential" and "arise from."  The 
Oxford English Dictionary defines potential as "[p]ossible as opposed to actual; having or showing the capacity to develop into something in the future; latent; prospective."
583  Additionally, in EC – 
Hormones  the Appellate Body observed that the ordi nary meaning of 'potential' relates to 
'possibility'.584  The American Heritage Dictionary defines "a rise" as to come into being, originate, to 
result, issue or proceed.585 
7.482  The Appellate Body's findings in both EC – Hormones  and Japan – Apples  inform the 
definition of risk assessment in Annex A(4) second sen tence.  The Appellate Body has found that the 
requirement to conduct a risk assessment is not satis fied merely by a general discussion of the disease 
sought to be avoided by the imposition of  a sanitary of phytosanitary measure.586   
7.483  Specifically, in EC – Hormones  the Appellate Body concluded th at a risk assessment in this 
instance required not a general evaluation of th e carcinogenic potential of entire categories of 
hormones, but rather should include an examina tion of residues of those hormones found in meat 
derived from cattle to which the hormones had b een administered for growth promotion purposes.587 
7.484  In Japan – Apples  the Appellate Body clarified that a ri sk assessment should refer in general 
to the harm concerned as well as  to the precise agent that may possibly cause the harm.588  In a 
footnote, the Appellate Body explained 
"Indeed, we are of the view that, as a general matter, 'risk'  cannot usually be 
understood only in terms of the disease or ad verse effects that may result.  Rather, an 
evaluation of risk must connect the possibilit y of adverse effects with an antecedent 
or cause.  For example, the abstract re ference 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', th e particular risk is given content."589  
7.485  Given the Appellate Body's guidance and the or dinary meaning of the terms "potential" and 
"arising from", the Panel concludes that the Eur opean Communities was required 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. 
                                                      
582 1999 Opinion, page 72, Exhibit CDA-2. 
583 The New Shorter Oxford English Dictionary  (Thumb Index Edition, 1993), p. 2310. 
584 (footnote original)  The dictionary meaning of "potential" is "that which is possible as opposed to 
actual; a possibility"; L. Brown (ed.), The New Shorter Oxford English Dictionary on Historical Principles , 
Vol. 2, p. 2310 (Clarendon Press, 1993).  In contrast , "probability" refers to "degrees of likelihood; the 
appearance of truth, or likelihood of being realized", and "a thing judged likely to be true, to exist, or to 
happen"; Ibid., p. 2362. 
585 The American Heritage Dictionary of the English Language (4th ed., 2000). 
586 Appellate Body Report on Japan – Apples , para. 202. 
587 Appellate Body Report on EC – Hormones , para. 200. 
588 Appellate Body Report on Japan – Apples , para. 202. 
589 Appellate Body Report on Japan – Apples , at footnote 372.  WT/DS321/R 
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  7.486  The Panel, as noted above, will not conduct its own risk assessment or impose its own 
scientific opinions on the European Communities.590  However, the Panel must make an objective 
assessment of whether the Opinions issued by the SCVPH satisfy the definition contained in 
Annex A(4) to the SPS Agreement .   
7.487  As a preliminary matter, the Panel notes that there has been significant debate between the 
parties about the relevance of the Codex and JE CFA definitions of the various phases of a risk 
assessment as well as about a risk assessment's role in the larger process of risk analysis, which 
consists of three components: risk assessmen t, risk management, and risk communication.591   
7.488  The Panel also recalls that the European Comm unities argues that the broader concept of risk 
analysis, as defined by Codex, including the risk ma nagement phase, must be considered in evaluating 
whether the European Communities conducted a risk assessment within the meaning of Article 5.1 
and Annex A(4). 
7.489  Specifically, the European Communities points out  that, as defined by Codex, risk assessment 
is normally considered to be only the first component of a three part process.592  The European 
Communities argues that Canada makes little or no reference to the second component of risk 
analysis, which has to be completed after  the completion of the four steps of risk assessment, namely 
risk management.  The European Communities defi nes risk management as the process of "weighing 
policy alternatives in the light of the results of risk assessment and, if required, selecting and 
implementing appropriate control opti ons, including regulatory measures."593  The European 
Communities also asserts that the Appellate Body h as confirmed that a risk  assessment within the 
meaning of Article 5.1 includes a risk management st age which is the responsibility of the regulator to 
carry out and not of the scientific bodies.594 
7.490  The Panel agrees with the European Communities th at the relevant definition against which to 
measure the EC Opinions in order to determine wh ether they constitute a ri sk assessment is the one 
contained in the SPS Agreement,  namely that set forth in Annex A(4).  As noted above, the Panel has 
found that the text of Annex A(4) second senten ce defines a risk assessment as evaluating the 
possibility that an identified adverse effect came in to being, originated, or  resulted from the presence 
of the identified additives, contam inants, toxins or disease-causing organisms in food, beverages or 
feedstuffs.  
7.491  The European Communities argues that th e Appellate Body in the original EC – Hormones 
case confirmed that a risk assessment within the meaning of Article 5.1 includes a "risk management" stage which entails weighing policy alternatives in li ght of the results of risk assessment and, if 
required, selecting and implementin g appropriate control options, in cluding regulatory measures.  
Although the Appellate Body disapproved of the original panel's distinction between "risk 
assessment" and "risk management" because it had no textual basis in the Agreement, this Panel can 
find no statement by the Appellate Body confirmi ng that what the European Communities describes 
as risk management is included within the definition of  a risk assessment 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 .
595 
                                                      
590 See para. 7.432 above. 
591 Codex Procedural Manual, 15th ed., p. 44. 
592 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 135. 
593 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 136-137. 
594 EC's second written submission , para.116. 
595 Appellate Body Report on EC – Hormones , para. 181.  WT/DS321/R 
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  7.492  The Panel agrees with the Appellate Body that its  role as a treaty interpreter is to "read and 
interpret the words actually used by the agreem ent under examination, and not words which the 
interpreter may feel sh ould have been used."596  The Panel takes note of the Appellate Body's finding 
that a risk assessment can take into account "matte rs not susceptible of quantitative analysis by the 
empirical or experimental laboratory methods commonly associated with the physical sciences."597  
However, the Panel finds that neither that finding nor the text of the Agreement includes within the 
definition of a risk assessment the concepts put  forward by the European Communities as "risk 
management."  Therefore, the Panel maintains that it must determine whether the European 
Communities evaluated the possibility that the identifi ed adverse effects 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 promotion purposes.  To that end, the Panel 
requested the opinions of the scientific experts on what, exactly, the European Communities evaluated 
in its Opinions. 
7.493  The Panel specifically asked the experts whether the EC  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 whic h this hormone had been administered for 
growth promotion purposes in accordance with good ve terinary practice and to what extent the 
Opinions evaluated the potential o ccurrence of these adverse effects.
598 
7.494  Dr. Boobis concluded that "the EC has not identified the potential for adverse effects on 
human health of residues of oestradiol found in m eat from treated cattle.  This is because the analysis 
undertaken was focused primarily on hazard identifi cation.  There was little in the way of hazard 
characterization, and no independent  exposure assessment was undertaken.599 
7.495  Dr. Guttenplan concluded that the European Communities had done a thorough job in 
identifying the potential for adverse effe cts on human health of oestradiol-17 β found in meat derived 
from cattle to which this hormone had been administ ered.  Specifically, Dr. Guttenplan found that the 
European Communities had identified a number of po tential adverse effects, established metabolic 
pathways relevant to these effects, and examined mechanisms of these effects.  In addition it had 
performed thorough studies of residue levels in ca ttle, and the environment.  Dr. Guttenplan also 
concluded that the evidence evaluating the occurrence of adverse effects is weak.  He found that the 
animal models were very limited a nd the target organs do not coincide well with the target organs in 
humans.  He also pointed out that there are "b asically no epidemiological studies comparing matched 
populations consuming meat from untreated and horm one-treated cattle.  Thus, little can be inferred 
about the potential occurrence of the adverse ef fects, the potential for adverse effects seems 
reasonable."600  
7.496  Dr. Boisseau noted that "in the 1999 report, SC VPH concluded also that '... it is clear that 
exogenous oestrogens, present in oral contraceptives or used in hormonal replacement therapy in 
women, are responsible for an increase of endometri al cancer and, to lesser extent, some increased 
risk of breast cancer, [but] there is no direct ev idence on the consequences of the contribution of 
exogenous oestradiol-17 β originating from the consumption of treated meat'."601 
7.497  Dr. Cogliano observed that even though th e European Communities does demonstrate 
through scientific evidence that oestradiol-17 β is genotoxic, the issue is whether this genotoxicity 
                                                      
596 Appellate Body Report on EC – Hormones , para. 181.  
597 Appellate Body Report on EC – Hormones , para. 187. 
598 Panel question 13 to the scientific experts, Annex D, p. 22. 
599 Replies by the scientific experts to Panel questions, Annex D, para. 144. 
600 Replies by the scientific experts to Panel question 13, Annex D, para. 145. 
601 Replies by the scientific experts to Panel questions, Annex D, para. 132.  WT/DS321/R 
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  would occur at levels found in meat residues.  In  that respect, Dr. Cogliano concluded that the 
European Communities has not established that genotoxicity and cell proliferation would be induced 
by levels found in meat residues added to th e pre-existing levels occurring in exposed humans.602 
7.498  The Panel specifically asked the expert s whether the European Communities had 
demonstrated 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.  
Dr. Boisseau concluded that the European Comm unities did not demonstrate that a potential for 
adverse effects on human health arises from the cons umption of meat from cattle treated with any of 
the six hormones in dispute for growth promotion pur poses.  Additionally, Dr. Boisseau stated that the 
kind of evidence required to demonstrate such poten tial adverse effects should be (a) toxicological 
data indicating that the values of the ADIs established by JECFA ar e not conservative enough, and (b) 
data on residues in treated/non-treated cattle and on daily production of hormones in sensitive 
individuals603 indicating that the hormonal residue intake associated with the consumption of meat 
from treated cattle is such that the established ADI s would be exceeded in the case of use of growth 
promoters.604 
7.499  Dr. Boobis stated that, in his view, none of the information provided by the European 
Communities demonstrates the potential for adverse e ffects 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 st udies on genotoxicity provide no convincing evidence 
of potential for harm in consumers.  The carcinogeni c 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.605 
7.500  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 estrogen ... and its low levels  in meats, it appears possible that intake levels 
would be within an order of magnitude of those of  the daily production rate.  This is greater than 
FDA's 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 children and post-menopausal women.  
If practical, this experiment would be important in establishing or refuting the arguments of the 
EC."606  
7.501  To the extent that the Europ ean Communities argues that the re levant risk from hormones is 
an "additive risk" the experts concluded that th e European Communities di d not assess the extent to 
which residues of growth promoting hormones in m eat contribute to additive risks arising from the 
cumulative exposures of humans to multiple hazards, in addition to the endogenous production of 
some of these hormones by animals and human beings.607 
7.502  Dr. Cogliano explains that even if the fact that a substance is a carcinogenic hazard led an 
agency to make a decision on the qualitative element alone, many agencies still prefer to examine the 
exposure in their country to determine what to do.608  Indeed Dr. Boobis indicates that stopping the 
                                                      
602 Replies by the scientific experts to Panel questions, Annex D, para. 180. 
603 Such as prepubertal children. 
604 Replies by the scientific experts to Panel questions, Annex D, para. 406. 
605 Replies by the scientific experts to Panel questions, Annex D, para. 408. 
606 Replies by the scientific experts to Panel question 52, Annex D, para. 413. 
607 Replies by the scientific experts to Panel question 56, Annex D, paras. 422-431. 
608 Transcript of the Panel meeting with the experts, Annex G, para. 438. WT/DS321/R 
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  risk assessment once it was identified that the hazar d was such that the dose response was going to be 
linear, i.e. there is no threshold, would be an unusual circumstance.  He  states that in most 
circumstances one would want to understand the re lationship between the hazard and the level of 
exposure that was occurring.  For that reason one  would progress at least to a semi-quantitative 
evaluation of the exposure and risk, rather than just stopping at a simple identification of hazard.609 
7.503  Finally, the Panel has looked at the Opinions and found statements that indicate that specific 
studies on the potential for the adverse health effect s 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.   
7.504  The 1999 Opinion looked at three main areas of  potential adverse effects:  developmental 
effects on different stages of life; the relationship be tween oestrogens and cancer; and the effect of sex 
hormones on the immune system.  In each of these areas, little or no data was presented directly that 
any of the potential adverse health effects identifie d come into being, originate, or result from the 
consumption of meat and meat products which contain veterinary residues of oestradiol-17 β as a 
result of the cattle being treated with the hormone for growth promoting purposes. 
7.505  With respect to the developm ental effects of exogenous sex hormones, the 1999 Opinion 
recites generally the biological functions of sex hormones in the biological development of a human 
being and cites to studies that involve the appli cation of diethylstilbestrol (DES) in experimental 
settings, even though DES is not one of the possible sources of oestradiol-17 β residues in meat from 
treated cattle.610 With respect to prepubertal children, the 1999 Opinion again cites studies having to 
do with DES as well as testosterone and allylestrenol  (a steroid used in prevention of spontaneous 
abortion).611 Although the developmental effects of o estrogens are discussed generally, including 
some potential adverse health effects, there is no examination of whether these effects arise from 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.  In fact, the 1999 Opinion states that "the 
information available so far falls short of the ideal, or even the sufficient sta ndard to allow observers a 
well informed judgment when assessing exposure re garding what is acceptable from what is not."612   
7.506  Regarding cancer, the 1999 Opinion states that "no study has assessed the effects of hormones 
as growth promoters in farm animals on cancer occu rrence in humans.  Arguments to be considered 
when evaluating the hypothesis of a potential link betw een the use of food promoters in farm animals 
and cancer in humans come both from descriptive ep idemiology, including studies in migrants, and 
etiologic epidemiology on diet an d cancer as well as on hormones and cancer."613  "Currently one 
cannot confirm nor refute the association between high rates of breast cancer and high hormone-treated meat consumption in North-Ameri ca.  This should be urgently studied."
614  Additionally, the 
1999 Opinion noted that: 
"The difficulty of evaluating health effects at low dose is here compounded by the 
fact that the data on exposures of human populations are exceedingly limited.  No 
large data are available on representative samples of foods collected in countries 
allowing or banning growth promoters in farm  animals.  Most often, published levels 
concern measurements realized by the pr oducers of the substances themselves under 
experimental conditions.  However, data on the concentration of hormones and their 
                                                      
609 Transcript of the Panel meeting with the experts, Annex G, para. 442. 
610 1999 Opinion , pp. 5-16 . 
611 1999 Opinion, p. 13. 
612 1999 Opinion, p. 6. 
613 1999 Opinion, p. 16. 
614 Ibid.  WT/DS321/R 
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  metabolites present in edible tissues of treated  animals are lacking.  In addition, the 
methods used for measurements require a criti cal reappraisal.  Data on the nature and 
amount of metabolites produced by the target animal are missing."615  
7.507  Finally, in examining the effect of sex hormones on the immune system, the 1999 Opinion 
states that "no sound epidemiological data are curre ntly available to establish a link between nutrition, 
especially meat consumption, and the occurrence of  (and apparent current increase in) autoimmune 
diseases."616  Additionally, the 1999 Opini on found that  relevant data 
"indicate that oestrogens modulate the immune system in many species.  Direct 
human data at near physiological levels of oestradiol are lacking.  Vingerhoets et. al., 
(1998) have conducted a self-reporting ques tionnaire study of DES daughters.  A 
statistically significant difference in the incidence of infections was identified 
compared with control.  This may be consid ered to be linked to imprinting by DES in 
utero. 
In conclusion, at relatively high doses o estradiol 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 e ffects could occur in consumers from the 
ingestion of meat or meat products  containing oestradiol residues."
617 
7.508  The 1999 Opinion cited a new method for determ ining blood levels of oestradiol which 
suggested that the levels were 100 fold lower than  previously determined and the metabolic clearance 
rate too high by a factor of 10.  The 1999 Opinio n concluded that if these methods were correct the 
acceptable daily intake established by the US Food  and Drug Administration for meat and meat 
products derived from treated cattle would be at least  85 fold and possibly as much as 1,700 fold too 
high.  However, the 1999 Opinion went on to note that "[g]iven all of the uncertainties in these 
estimates, it appears that the data are insufficien t to form the basis of a sound risk assessment."618 
7.509  All of the statements of the experts, and ind eed statements from the Opinions, indicate that 
the European Communities has evaluated the poten tial for the identified adverse effects to be 
associated with oestrogens in general, but has not pr ovided analysis of the potential for these effects to 
arise from consumption of meat and meat produc ts 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 Communities has evaluated the 
association between excess hormones and neurobi ological, 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 po ssibility that these adverse effects co me 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. 
                                                     
 
615 Ibid., p. 20 
616 1999 Opinion, pp. 22-23. 
617 1999 Opinion, p. 45. 
618 1999 Opinion, pp. 38-39. WT/DS321/R 
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  Does the science support the conclusions of the Opinions?  
Introduction 
7.510  The Panel agrees with the reasoning of the Panel in Japan – Apples (Article 21.5 – US)  that 
"the scientific evidence which is being evalua ted must support the conclusions of the [risk 
assessment]. Therefore, if the conclusions of the ri sk assessment are not sufficiently supported by the 
scientific evidence referred to in the [risk asse ssment], then there cannot be a risk assessment 
appropriate to the circumstances, w ithin the meaning of Article 5.1".619  Although the Panel has 
already found, above, that the Opinions do not  satisfy the definition of a risk assessment in 
Annex A(4) of the SPS Agreement , the Panel wishes to ensure that  it has conducted a complete and 
objective assessment of the facts.  Therefore, in  determining whether the European Communities 
complied with Article 5.1, the Pane l will determine whether the scientif ic evidence referred to in the 
Opinions supports the conclusions contained therein. 
Summary of the main arguments of the parties620 
7.511  Canada  recalls that the most important conclusion of the SCVPH relied upon by the 
European Communities to justify its continued ban on oestradiol-17 β as a growth promoter is that this 
hormone is genotoxic.  According to Canada, the problem with the SCVPH's conclusion about 
genotoxicity is that it is not supported by the eviden ce. This can be demonstrated with reference to the 
SCVPH's own opinions. It can be demonstrated with  reference to the work of other international 
scientific authorities. And it can be demonstrated with reference to the European Communities' own 
conclusions. 
7.512  First, Canada argues, the SCVPH itself acknowledges that its conclusion about the 
genotoxicity of oestradiol-17 β is simply a hypothesis, based on a limited set of studies done either in 
vitro or on laboratory specimens under unrealistic conditions.  The hypothesis is that one single 
reactive metabolite can damage DNA and lead to tumour initiation. It is on the basis of this 
conclusion that the SCVPH concludes that a thres hold does not exist for carcinogenic effects arising 
from exposure to oestradiol-17 β and its metabolites.  
7.513  Canada considers that the EC hypothesis co mpletely disregards established scientific 
evidence that mechanisms exist within the human body to control the formation of potentially 
genotoxic metabolites in vivo and to eliminate DNA a dducts that may be formed.  The Opinions make 
only passing reference to "inactivating processes", but then go on to assume that these inactivating 
processes are insufficient in the case of catechol oestrogens.621 This conclusion is surprising in the 
light of the SCVPH's own acknowledgement that "[ n]o data are currently available on the genotoxic 
effects of exogenous low-dose oestrogens." As a result, the SCVPH conclusions about the potential 
occurrence of tumours as a result of  the genotoxicity of oestradiol-17 β, on which the European 
Communities relies, amounts to no more than the identification of theoretical risk. 
7.514  According to Canada, other scientific and regul atory authorities have a ll indicated that the 
SCVPH's conclusion on the genotoxicity of oestradiol-17 β is more theory than reality. For example, 
in its replies to the Panel's questions, the Eur opean Communities cites numerous times a 2000 report 
by JECFA in which JECFA acknowledges the "genotoxic potential" of oestradiol-17 β.  However, 
what the European Communities fails to indicate is that in the same re port, JECFA also stated that it 
                                                      
619 Panel Report on Japan – Apples (Article 21.5 – US) , para. 8.136 (original footnote omitted). 
620 A more detailed account of the parties' arguments can be found in the descriptive part of this Report.  
The order in which the respective arguments of the partie s are presented does not reflect any allocation of the 
burden of proof by the Panel. 
621 1999 Opinion, p. 72, Exhibit CDA-2.  WT/DS321/R 
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  was "not certain that this pathway is relevant in vi vo at physiological concentrations of estradiol." In 
the end, JECFA concluded that "the carcinogenicity of estradiol-17 β is most probably a result of its 
interaction with hormonal receptors." In the light of its conclusion that receptor-based carcinogenicity 
is dose-dependent, JECFA identified a th reshold level and established an ADI.  
7.515  Canada adds that, after reviewing the evidence related to the genotoxicity of oestradiol-17 β, 
the Committee for Veterinary Medicinal Products (C VMP) of the European Medicines Agency came 
to a similar conclusion in a 1999 report. It found  that new studies confirmed the earlier findings and 
clearly indicated that hormones and/or their synt hetic analogues were not associated with genotoxic 
properties. 
7.516  Finally, Canada notes that when considering exposure to oestradiol-17 β when used as a 
growth promoter, the European Communities is cat egorical about the risks arising from one single 
reactive oestradiol metabolite and hence concludes that  to achieve its appropriate level of protection it 
must not allow exposure to even one molecule. However, even though the European Communities 
expresses significant concern about the risks from oestradiol-17 β metabolites from meat from treated 
animals, the European Communities appears not to find it necessary to  even provide health advisories 
about the potential risks from other sources.622  
7.517  The European Communities  argues that it is important to understand that the issue of the 
dose administered is not relevant for the in vivo  genotoxicity in the case of oestradiol-17 β.  The 
European Communities goes on to note that it appears that the doses used to elicit in vivo  
mutagenicity623 are not massively high, but rather that they seem to fall within the safety margin 
established by JECFA, which means that the residu es in meat from hormone-treated cattle are also 
capable of producing this adverse effect.624 
7.518  The European Communities argues that the onl y rationale that can be inferred from the 
available scientific data is that the higher the exposure to residues from these hormones, the greater 
the risk is likely to be.625  The European Communities goes on to  say that the risk resulting from 
human consumption of meat from cattle treated with oestradiol-17 β for growth promotion purposes, 
according to good veterinary practice, is "assessed in  the real world" where "people live, work and 
die", or may be suffering from clinical disorders, or may be particularly vulnerable segments of the 
population (e.g ., like prepubertal children), etc.626 
7.519  The European Communities notes that  it is scientifically undisputed that life-time exposure of 
human to the levels of endogenous production of oestrogen (and in particular to oestradiol-17 β and its 
metabolites) are sufficient to cause and/or promote can cer in some individuals.  This is frequently 
called risk of cancer from background (endogenous) exposure.  This kind of exposure (and the 
attentive risk of cancer) cannot be avoided.  Th e European Communities also  notes that humans are 
exposed daily to variable levels of residues of oestradiol-17 β from many exogenous sources where 
these hormones naturally occur, which likewise cannot be avoided.627   
                                                      
622 Canada's second written submission, paras. 86-98. 
623 Ability of a physical, chemical, or biological agent to induce heritable changes (mutations) in the 
genetic material in a cell as a consequence of alteratio ns or loss of genes or chromosomes (or parts thereof) 
(replies of Dr. Boobis and Dr. Guttenplan to Panel question 2 to the experts.  Annex D, paras. 34 and 55). 
624 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 23. 
625 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 94. 
626 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 94 and 96. 
627 EC's replies  to Panel questions after the second substantive meeting, Annex C-1, paras. 48-49. WT/DS321/R 
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  Reasoning of the Panel 
7.520  The Panel's task is to determine whether the scientific evidence supports the conclusions in 
the Opinions.  The Panel notes in this respect that  the 1999 Opinion concluded that "for oestradiol 
genotoxicity has already been demonstrated explicitly."628  The 1999 Opinion also concluded that 
oestradiol-17 β is a complete carcinogen that exhibits tumour initiating and tumour promoting 
effects.629  Finally, the 1999 Opinion found 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.630  In the 2000 and 2002 Opinions, the SCVPH concluded that 
none of the additional science developed in the inte rvening years justified changing those conclusions. 
7.521  The Panel is not in a position to evaluate the scientific data the SCVPH reviewed in drawing 
its conclusions.  For this reason, the Panel consulted a group of scientific experts and asked them to 
evaluate the EC Opinions as well as the underlying science.  
7.522  The European Communities urged the Panel to disregard the responses of two particular 
experts because their positions are "purely theoreti cal" and for the additional reason that they have 
"never done any specific research on these hormones nor have they published something on these 
substances."631  In that vein, the European Communities cit es to the Appellate Body's rejection of an 
opinion given by a scientist in the original EC – Hormones  dispute in 1998 becau se it did not "purport 
to be the result of scientific studies carried out by him or under his supervision focusing specifically on residues of hormones in meat from cattle fattened with such hormones ..."
632  However, the Panel 
finds that Appellate Body in its report on EC – Hormones spoke to a different issue.  In that instance 
the scientist was making specific estimates about the likelihood of breast cancer being caused by 
eating meat containing oestrogens, even though the scientist had not studied the matter. 
7.523  In this case, the Panel has asked the experts not  to make their own scientific conclusions but 
to evaluate the Opinions as experts in the conducting of risk assessments on food additives and 
contaminants and to assist the Panel in determin ing whether the evidence relied upon by the SCVPH 
supports the conclusions in its Opinions.  To that  end the Panel found the comments by all the experts 
helpful in its analysis and none shall be disregarded   
7.524  In response to specific questions from the Panel, the experts provided the following 
information. 
7.525  With respect to the genotoxicity of oestradiol-17 β, Dr. Boisseau explained that JECFA's 
conclusion that oestradiol-17 β had genotoxic potential was based on the general agreement that 
oestradiol-17 β is associated with a genotoxic effect, thus  
"... although it recognized that oestradiol-17 β does not lead to positive results in all 
the classical tests which have been used  to demonstrate its genotoxicity and its 
mutagenicity (oestradiol-17 β did not cause gene mutations in vitro  and gives, in some 
assays, sporadic but unconfirmed positive results), JECFA, in its fifty second session 
held in 1999 concluded 'that oestradiol-17 β has genotoxic potential.'"633 
                                                      
628 1999 Opinion, p. 75, Exhibit CDA-2. 
629 1999 Opinion, p. 73. 
630 1999 Opinion , p. 71. 
631 EC's comments on experts replies to Panel questions, Annex F-1, pp. 35-36. 
632 EC's comments on experts replies to Panel que stions, Annex F-1, p. 14 citing Appellate Body 
Report on EC – Hormones , para. 198. 
633 Replies by the scientific experts to Panel questions, Annex D, paras. 134-135.  WT/DS321/R 
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  7.526  In evaluating the EC assertion that th e fact that doses of oestradiol-17 β used in growth 
promotion are low is irrelevant because there is  no threshold for substances which have genotoxic 
potential, Dr. Boisseau stated that the general prin ciple did not apply to naturally occurring hormones, 
which are produced by both humans and food producing an imals.  Dr. Boisseau noted that even in the 
absence of any consumption of food coming from animals treated by growth promoting hormones, humans are naturally and continuously exposed to  these natural hormones through, among others, (a) 
their own production of these hormone s which may be very high, for example in the case of pregnant 
women, (b) the consumption of meat from non treated  cattle, (c) the consumpti on of meat from other 
food producing animals, (d) the consumption of milk  and eggs.  There is no epidemiological survey 
indicating that this continuous exposure of humans  to these natural hormones results in any identified 
risk for health.
634 
7.527  Dr. Cogliano explained that "the EC's statemen t that a threshold cannot be identified reflects 
their view of genotoxic mechanisms, just as the contra ry statement that there is a threshold and that 
this threshold is above the levels found in meat  residues reflects how Canada and the US view 
genotoxic mechanisms.  Neither statement has been demonstrated by the scientific evidence, rather, 
they are different assumptions that each party uses in  their interpretation of the available evidence."635 
7.528  Dr. Guttenplan replied that  
"[T]he data referred to by the EC s upports a genotoxic mechanism as well as a 
hormonal mechanism.  It is true that there is no reason to expect a threshold to exist for a genotoxic chemical.  Although DNA repair can occur, it presumably is 
occurring at all doses and the fraction of  DNA damage repaired probably does not 
change at physiological levels, because th e repair enzymes are unlikely to be 
saturated.  The statement that, 'the fact that  doses used in growth promotion are low is 
not of relevance' is not necessarily true.  (para. 118-119 of EC Rebuttal Submission 
(US case)).  For any toxin the dose determin es the risk.  When exposure is very low 
risk will be very low.  However, one can ar gue about the definition of 'low'.  It should 
also be noted that at very low levels of  genotoxic carcinogens the decrease in risk is 
more than proportional than the decrease in applied dose."
636 
7.529  Dr. Cogliano stated in his written responses that the identification of oestradiol-17 β as a 
human carcinogen indicates that there are poten tial adverse effects on human health when 
oestrodiol-17 β is consumed in meat from cattle treated with hormones for growth promotion 
purposes.637  At the meeting with the Panel, Dr. Cog liano clarified that the IARC has classified 
oestradiol-17 β as possibly carcinogenic based on sufficient ev idence in experimental animals.  The 
agents that are known to be carcinogenic in hum ans are the steroidal oestrogens, non-steroidal 
oestrogens, and various oestrogen- progestin combinations as used e ither as birth-control pills or 
menopausal therapy.638 
7.530  Dr. Boobis concluded that there is no good evidence that oestradiol is genotoxic in vivo  or 
that it causes cancer by a genotoxic mechanism.  I ndeed the evidence is agai nst this.  Hence, the 
scientific evidence does not support the European  Communities' position that the levels of the 
hormones in meat from treated cattle are not of relevance.639 
                                                      
634 Replies by the scientific experts to Panel questions, Annex D, para. 182. 
635 Replies by the scientific experts to Panel questions, Annex D, para. 186. 
636 Replies by the scientific experts to Panel questions, Annex D, para. 187. 
637 Replies by the scientific experts to Panel questions, Annex D, para. 154. 
638 Transcript of the Panel meeting with the experts, Annex G, para. 327. 
639 Replies by the scientific experts to Panel questions, Annex D, para. 184. WT/DS321/R 
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  7.531  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 studi es 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.
640 
7.532  With respect to the carcinogenic and tumour promoting qualities of oestradiol-17 β, 
Dr. Boisseau noted that if the SCVPH, in the 1999 Opinion, expresses its concern in concluding that 
"[f]inally, in consideration of the recent data on the formation of genotoxic metabolites of oestradiol 
suggesting oestradiol-17 β acts as complete carcinogen by exerting tumour initiating and promoting 
effects ... no quantitative estimate of the risk related to residues in meat could be presented," it provides no data indicating that oestradiol-17 β is associated with the increase of tumours in tissues or 
organs which are not hormone dependent.
641  Dr. Boisseau concludes that "the EC risk assessment did 
not support that residues of oestradiol-17 β, despite the genotoxic potential of this hormone, can 
initiate and promote tumours in humans."642 
7.533  In addition, Dr. Boisseau concluded that the scientific evidence relied upon in the Opinions 
does not support the conclusion that carcinogenic effects of oestradiol-17 β are related to a mechanism 
other than hormonal activity.643 
7.534  Dr. Boobis also pointed out that the evidence is against direct modification of DNA in vivo  by 
hormones in meat from treated animals, or by their metabolites produced in vivo .  Indirect 
modification could conceivably come about by  products of active oxygen.  The DNA repair644 
processes for this are amongst the most efficient ( Arai et al, 2006; Russo et al, 2004)  and even if such 
modification did occur, it is anticipated that no her itable change would result, because of DNA repair 
(Arai et al, 2006) .  This would be true even at the levels  of exposure that could arise should GVP not 
be followed.645 
7.535  Dr. Boisseau also expressed his opinion that epidemiological studies carried out in humans 
during long enough to take into account this "long late ncy period" will not be able to discriminate, in 
the case of a possible but limited increase of tumours, between the responsibilities of (a) hormone residues resulting from the treatment of food produc ing animals by growth promoting hormones, (b) 
hormone residues resulting from the endogenous production of these animals, and (c) other 
components of the diet including other food additives and contaminants.  That is the reason for which, 
to his knowledge, even though the hormones in disput e have already been used as growth promoters 
over a significant number of years, the epidemiologi cal studies in humans already carried out in this 
domain have failed to identify any relation between  the occurrence of hormonally dependent tumours 
and the consumption of meat containing hormonally  active residues resulting from the treatment of 
cattle with growth promoters.
646 
                                                      
640 Replies by the scientific experts to Panel questions , Annex D, para. 136. 
641 Replies by the scientific experts to Panel questions, Annex D, para. 141. 
642 Replies by the scientific experts to Panel questions, Annex D, para. 142. 
643 Replies by the scientific experts to Panel questions, Annex D, para. 156. 
644 DNA repair mechanisms refer to the ability of an organism to recognize different types of damage 
to DNA and repair it (replies of Dr. Boobis and Dr. Guttenplan to Panel question 22 to the experts, Annex D, 
paras. 201 and 204). 
645 Replies by the scientific experts to Panel questions, Annex D, para. 202. 
646 Replies by the scientific experts to Panel questions , Annex D, para. 209.  WT/DS321/R 
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  7.536  In response to the citation by the European Communities of da ta indicating different cancer 
rates between the United States and Europe, Dr. Boobi s stated that there is  no scientific evidence 
demonstrating any association between consumpti on of meat from animals treated with growth 
promoting hormones and the risk of cancer in humans.  Dr. Boobis acknowledged that an appreciable number of studies show an association between a risk of certain cancer types and the consumption of meat, however he pointed out that the studies show  little relationship with whether the meat is from 
animals treated with growth promoting hormones or  not.  Dr. Cogliano noted that although it is 
possible that differences in exposure to exogenous  hormones could be one cause of the different 
breast cancer rates in the United States and the Eur opean Communities, the data are not sufficiently 
specific to establish a link.  Dr. Guttenplan also c oncluded that the epidemiological studies do not 
identify a relationship between cancer and residues of hormonal growth promoters.
647 
7.537  Additionally, in response to direct questioni ng during the Panel meeting with the experts, 
Drs. Boobis, Boisseau, and Guttenplan all agreed th at 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 purposes.  While all the experts who r esponded to the question agreed that a zero risk 
could not be guaranteed, the actual level of risk w as in their view so small as to not be calculable.648 
7.538  Finally, the Opinions themselves contain stat ements that indicate th at the science does not 
support the conclusions in the Opinions.  The 1999 Opin ion considered that the link, if any, between 
cancer and consumption of hormone-treated meat  cannot, at present, be confirmed nor refuted.649 It is 
also important to note that the only study cited with respect to cancer in susceptible  populations, such 
as foetuses and prepubertal children, has to do with in utero  exposure to DES, which is banned in 
Canada and is not the source of the oestradiol-17 β residues in the meat and meat products that are the 
subject of the European Communities' ban.650 
7.539  With respect to the other potential adverse e ffects identified by the European Communities, 
the 1999 Opinion also concludes that no sound ep idemiological data are currently available to 
establish a link between nutrition, especially meat c onsumption, and the occurrence of (and apparent 
current increase in) autoimmune diseases.651   As to the developmental effects of exogenous sex 
hormones on puberty in humans, the 1999 Opini on noted that although precocious puberty is 
somewhat common in the United States, "the im portance of environmental oestrogenic compounds 
present in plastics, insecticides, and meat from animals treated with sex hormones , while suggestive, 
remains as only a possibility in affecting an early onset of puberty."652   
7.540  The Panel has evaluated the evidence.  The Panel considered the SCVPH's own 
characterization of the science in the Opinions as we ll as the replies of the experts to the Panel's 
questions, the transcript of the experts meeting with th e Panel, and the submissions of the parties.  The 
Panel found that the views expressed by the experts who answered the questions, provided clear and 
consistent answers, and who had particular expertise in the re levant areas being discussed, were 
consistent with the statements in the Opinions cite d above.  The Panel's evaluation of the expert views 
and the plain language of the Opinions themselves leads the Panel to conclude 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 explicitly653, nor does it support the 
                                                      
647 Replies by the scientific experts to Panel questions, Annex D, paras. 224, 230, 231, 238, 239, 241 
and 242. 
648 Transcript of the Panel meeting with the experts, Annex G, paras. 704-742 
649 1999 Opinion, pp. 17-18. 
650 1999 Opinion, p. 21. 
651 1999 Opinion, pp. 22-23. 
652 1999 Opinion, p. 14. (emphasis added). 
653 1999 Opinion, p. 75. WT/DS321/R 
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  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.  
Additionally, the scientific evidence does not suppor t the European Communities' conclusions about 
the adverse immunological and developmental effe cts of consuming meat and meat products from 
cattle treated with oestradiol-17 β for growth promotion purposes.  Therefore, the Panel is of the view 
that the scientific evidence referred to in the Opinions does not support  the conclusions reached by the 
European Communities.  
Conclusion  
7.541  On the basis of the above, the Panel concl udes that, in its Opin ions, the European 
Communities took into account risk assessment techniqu es of the relevant international organizations.  
The Panel nonetheless concludes that the European Communities has not satisfied the requirements of 
the definition of a risk assessment contained in Annex A(4) of the SPS Agreement  and the scientific 
evidence evaluated does not support the conclusions in the risk assessment.  The Panel concludes that 
the European Communities has not conducted a risk assessment as appr opriate to the circumstances 
within the meaning of Article 5.1 of the SPS Agreement . 
(iii) Is the measure "based on" a risk assessment 
Introduction  
7.542  The second question to address when determining wh ether an SPS measure is consistent with 
Article 5.1 is whether that measure is "based on" a risk assessment.  For an SPS measure to be based 
on a risk assessment, there must be a rational relationship between the measure and the risk assessment.
654 
7.543  Specifically, the Appellate Body in EC – Hormones  explained that "Article 5.1, when 
contextually read as it should be, in conjunction with and as informed by Article 2.2 of the 
SPS Agreement , requires that the results of the risk assessme nt must sufficiently warrant -- that is to 
say, reasonably support -- the SPS measure at stake."655  The Appellate Body went on to explain that 
this requirement is a substantive one.656  
Summary of the main arguments of the parties657 
7.544  Canada  argues that, even if the Opinions are cons idered to constitute a risk assessment, the 
EC measure is not "based on" that risk assessment. 
7.545  According to Canada, all that the SCVPH has arguably identified are some potential adverse 
effects associated with oestradiol-17 β per se . It has not demonstrated that these adverse effects occur 
as a result of consumption of the quantity of oestradiol-17 β in meat derived from treated farm 
animals.658  
7.546  Therefore, in Canada's view, even if the conclu sions of the Opinions on the adverse effects of 
oestradiol-17 β are correct, the rational response would be for the European Communities to ban 
oestradiol-17 β, or at least to inform consumers of the various sources of oestradiol-17 β and the 
                                                      
654 Appellate Body Report on EC – Hormones , para. 193. 
655 Appellate Body Report on EC – Hormones , paras. 193-194. 
656 Ibid. 
657 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
658 Canada's first written submission, paras. 101-108.  WT/DS321/R 
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  actions they should take to minimize exposure. It has instead chosen to respond to advice about the 
potential adverse effects of oestradiol-17 β from all sources by banning only meat from animals treated 
with oestradiol-17 β for certain purposes. As a result, the c onclusions of the Opinions do not support 
the conclusions underlying the measure, so the measure is not "based on" a risk assessment. 
7.547  The European Communities  replies that, in arguing that the ban on oestradiol-17 β is not 
based on a risk assessment, Canada essentially repeats its  arguments on the lack of specificity of the 
risk assessment.  The Euro pean Communities argues in this respect that it has identified the adverse 
effects of oestradiol-17 β and that it has evaluated their potential occurrence.659 
Reasoning of the Panel  
7.548  The Panel has concluded that the 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 scientific 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 assessm ent within the meaning of Article 5.1.660 
(iv) Conclusion 
7.549  In light of the above, the Panel conclud es that the EC implementing measure on 
oestradiol-17 β is not compatible with Article 5.1 of the SPS Agreement .   
(f) Compatibility of the EC implementing measure with Article 5.7 of the SPS Agreement  
(i) Introduction 
7.550  We have already concluded that the EC implementing measure does not comply with the 
provisions of Article 5.1 of the SPS Agreement .  To the extent that we are not seeking to determine 
any level of nullification or impairment, but rath er whether the European  Communities has removed 
the measure found to be inconsistent  with a covered agreement in the EC – Hormones  dispute, we 
could conclude at this stage that, by adopting Directive 2003/74/EC, the European Communities has not – fully – removed the measure found to be inconsistent with the SPS Agreement .  We recall, 
however, the purpose of our considering the EC claims  of violation of Article 23.1 of the DSU, read 
together with Article 22.8 and Article 3.7 of the DSU.  It is to assist the DSB in achieving a 
satisfactory settlement of the matter in accordance w ith the rights and obligations under the DSU and 
under the covered agreements, and to allow the Appe llate Body to make findings as may be necessary 
should it disagree with our findings in relation to Ar ticle 23.1 and 23.2(a) of the DSU.  We therefore 
proceed with a review of the conformity of the EC measure with Article 5.7 of the SPS Agreement .     
(ii) Summary of the main arguments of the parties
661 
7.551  The European Communities  argues that Directive 2003/74/EC provides that the use of five 
of the six hormones at issue is provisionally forbid den.  This ban is based on a comprehensive risk 
assessment and, thus, is fully compliant with the DSB recommendations and rulings. In  particular, as 
stipulated by the Appellate Body,  the results of the risk assessment provide the "available pertinent 
                                                      
659 EC's second written submission, para. 128. 
660 Panel Report on Japan – Apples (Article 21.5 – US) , para. 8.156 (concluding that because the 2004 
PRA did not amount to a risk assessment as appropriate to the circumstances, Japan's measure was not based on 
a risk assessment). 
661 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. WT/DS321/R 
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  information" on the basis of which the provisional prohibition regarding these five hormones has been 
enacted.  Consequently, the European Communities cl aims that, through Directive 2003/74/EC, it has 
implemented the rulings and recommendations in the EC – Hormones  case.662 
7.552  Canada  argues that the European Communities in th is case has failed to present any evidence 
to the Panel demonstrating that it meets any of th e four requirements recalled by the Appellate Body 
in order to comply with Article 5.7 of the SPS Agreement . 
7.553  For Canada, in the case of the five hormones at issue, the body of scientific evidence relating 
to these substances is such that the European Communities cannot plausibly argue that there is 
"insufficient" scientific evidence to conduct an adequate assessment of risk.  The five hormones 
banned by the European Communities have been the subject of several scientific assessments by 
reputable national regulatory agencies and internatio nal expert scientific committees, such as JECFA. 
Therefore, the EC contention that there is insuffi cient scientific evidence to conduct a risk assessment 
is unfounded, given that reputable  international bodies of scientific experts have in fact already 
performed risk assessments on the basis of th e scientific information at their disposal. 
7.554  Canada recalls that the second requirement fo r justifying a measure as a provisional measure 
under Article 5.7 is that the measure must be adopted  "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".  In the prese nt case, an objective analysis of the "available 
pertinent information" regarding the health risks associated with residues of these hormones in meat 
derived from animals treated with growth hor mones, including information from relevant 
international organizations and SPS measures applie d by other Members, does not reasonably support 
the European Communities' ban on these five hormones. 
7.555  Canada notes that the first sentence of Article  5.7 also requires that Members consider 
available pertinent information from "relevant inte rnational organizations" as a basis for adopting a 
provisional SPS measure. Based on the scientific ass essments conducted by JECFA in respect of these 
five substances as well as the adoption of Code x standards regarding these hormones, the EC 
measure, which continues the ban on these hormone s for growth-promotion purposes, is not based on 
the available pertinent information. 
7.556  Canada argues further that, under the second sentence of Article 5.7, the European 
Communities has an explicit obligation to collect a dditional information in order to review more 
objectively the appropriateness of its ban on these hormones. In this case, the European Communities 
has not demonstrated that it is complying with its  obligations under the second sentence of Article 5.7 
of the SPS Agreement . Although the Directive specifically indicates that the Commission shall seek 
additional information from all possible sources, the EC has provided no evidence of its efforts to 
obtain the necessary information to conduct a proper risk assessment.663 
7.557  The European Communities  argues that, since the EC – Hormones  case, the body of 
evidence has developed and, while still not providi ng enough knowledge to carry out a complete and 
definitive risk assessment, supports the conclusion that precautionary measures are required in order 
to achieve its chosen level of protection. 
7.558  According to the European Communities, the evid ence, while pointing to a number of risks, is 
full of gaps in pertinent information and important  contradictions have de veloped that render no 
longer valid the conclusions reached by JECFA in 1988, 1999 and 2000, thus not allowing a 
quantitative or qualitative risk assessment.  Accord ing to the European Communities, a number of 
                                                      
662 EC's first written submission, para. 17. 
663 Canada's first written submission, paras. 109-131.  WT/DS321/R 
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  significant scientific developments, taken together with  all other available evidence, indicates that it is 
not possible to undertake a definitive risk assessment for the five hormones concerned. 
7.559  Canada  replies that the European Communities provides no explanation of the alleged 
lacunae  in the relevant scientific evidence leading to its assertion, preferring instead to refer to the 
recitals of its measure which do not provid e any added information in this regard. 
7.560  Canada argues that it has demonstrated that ther e is a vast body of relevant scientific evidence 
on the safety of these five hormones when used for growth promotion purposes.  The European 
Communities has not demonstrated why it consid ers that, for example, the JECFA studies have 
yielded unreliable scientific evidence. The European  Communities seems to s uggest that the simple 
passage of time is sufficient to invalidate previo usly held scientific opini ons. But the European 
Communities does not provide any reasons why th e Codex standards and the JECFA studies should 
be considered to be based on "insufficient", scientific  evidence.  While maintaining that there is a lack 
of evidence pertaining to these issues, the European Communities disregards basic facts related to the 
hormones themselves and the numerous scientif ic reviews that they have undergone. 
7.561  According to Canada, the European Communiti es fails to adequately explain why it has 
adopted a measure banning the use of the five hor mones for growth promotion purposes when JECFA 
and the Codex Alimentarius Commission ha ve conducted safety assessments and adopted 
international standards that attest  to the safety of these substances. 
7.562  Canada adds that in situations where some evid ence of risk exists but not enough to complete 
a full risk assessment, a Member is not free to adop t any measure it wishes; it must adopt a measure 
based on what scientific evidence exists concerning the SPS issue in  question, including information 
from relevant international organizations.  In th e present case, the Europ ean Communities has failed 
to demonstrate that there is a rational relationshi p between its ban on the five hormones in question 
and the available pertinent information from JECFA and the Codex Alimentarius Commission. 
7.563  Canada agrees with the European Communities that the length of the reasonable period of 
time to review the appropriateness of the provisi onal SPS measures may vary from case to case 
depending on the difficulty in obtaining additional information and the characteristics of the SPS 
measure at issue. However, a Member's domestic legislative procedures may not have any impact on 
the determination of the reasonable period of time.  In cases of a total import ban such as the one 
facing Canada, the reasonable period of time to revi ew the provisional measure should be determined 
so as to minimize the extent of the trade impact of  such a measure which is not based on a full risk 
assessment and was, by implication, adopt ed without sufficient scientific evidence. 
7.564  Canada notes that the European Communities is  allegedly seeking the additional information 
necessary for a more objective assessment of risk. Ho wever, more than two years have passed since 
the adoption of the EC new directive banning the use of the five hormones in question. Yet the 
European Communities has provided no explanation as to how it has reviewed its measure in the light 
of the new information available since the adoption of the new EC Directive.664 
(iii) Approach of the Panel 
7.565  As a first remark, the Panel recalls its conclusion th at the measure at issue, to the extent that it 
provisionally bans the import of meat from ca ttle treated with the hormones progesterone, 
                                                      
664 Canada's second written submission, paras. 112-146. WT/DS321/R 
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  testosterone, trenbolone acetate, melengestrol acet ate and zeranol, is an SPS measure within the 
meaning of Article 1 of, and pa ragraph 1 of Annex A to, the SPS Agreement .665  
7.566  Second, both parties address the issue of the compatibility of the provisional ban on the 
above-mentioned five horm ones with the provisions of Article 5.7 of the SPS Agreement .  None of the 
parties discussed the compatibility of the ban impo sed with respect to these five hormones with 
Article 5.1.666  The Panel will therefore limit its review to the conformity of the EC ban on the five 
hormones with the requirements of Article 5.7. 
7.567  Article 5.7 of the SPS Agreement  provides as follows: 
"In cases where relevant scientific evid ence is insufficient, a Member may 
provisionally adopt sanitary ... measures on the basis of available pertinent 
information, including that from the releva nt international organizations as well as 
from sanitary ... measures applied by other Members.  In such circumstances, Members shall seek to obtain the add itional information necessary for a more 
objective assessment of risks and review the sanitary ... measure accordingly within a 
reasonable period of time."  
7.568  In Japan – Agricultural Products II , the Appellate Body recalled that Article.5.7 "set[s] out 
four requirements that must be satisfied in order to  adopt and maintain a provisional measure."  These 
requirements are: 
(a) the measure is imposed in respect to a situ ation where "relevant scientific evidence is 
insufficient"; 
(b) the measure is adopted "on the basis of available pertinent information"; 
(c) the Member which adopted the measure must "seek to obtain the additional 
information necessary for a more objective assessment of risk"; and 
(d) the Member which adopted the measure mu st "review the ... measure accordingly 
within a reasonable period of time".
667 
7.569  The Appellate Body noted that the four require ments are "clearly cumulative in nature", and 
that "[w]henever one of these four requirements is not met, the measure at issue is inconsistent with 
Article 5.7."668  
7.570  The Panel recalls that previous panels have addressed each of these requirements 
successively.  Having regard to our duty to revi ew the situation for each of the five hormones 
concerned by the provisional ban, we will proceed fi rst with the examination of the requirement under 
                                                      
665 See para. 7.425 above. 
666 The Panel asked a question to the parties on a possible "automatic" violation of Articles 2.2 and 5.1 
as a result of a violation of  Article.5.7 (second series of questions from the Panel to the parties, question 2).  
The Panel notes, however, that neither the European Communities nor Canada requested the Panel to review the 
compatibility of the EC implementing measure regarding the five hormones subject to a provisional ban with 
Article 5.1 or Article 2.2.  The Pane l also notes that the EC implementing measure is supposed to have removed 
the violation of Article 5.1 through the adoption of a provis ional ban compatible with Article 5.7.  In light of our 
approach to the aspect of this case relating to the compatibility of the EC implementing measure with the 
SPS Agreement , we decided to limit our review to the comp atibility of this measure with Article 5.7. 
667 See Appellate Body Report on Japan – Apples , para. 176, citing  the Appellate Body Report on 
Japan – Agricultural Products II , para. 89. 
668 Appellate Body Report on Japan – Agricultural Products II , para. 89.  WT/DS321/R 
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  (a) above, i.e. whether the measure is imposed with  respect to a situation where "relevant scientific 
evidence is insufficient". 
7.571  Moreover, having regard to the arguments of the parties and in line with our duty not to 
perform a de novo  risk assessment, we will limit ourselves to re view the issues with respect to which 
the parties exchanged arguments and provided sufficient evidence. 
7.572  We also note that Canada's main line of argum entation is that the body of scientific evidence 
relating to the substances at issue is such that "t he European Communities cannot plausibly argue that 
there is 'insufficient' scientific  evidence to conduct an adequate assessment of risk.  The five 
hormones banned by the European Communities ha ve been the subject of several scientific 
assessments by reputable national regulatory agenci es and international expert scientific committees, 
such as JECFA."669  In that context, we deem it appropriate  to determine to what extent relevant 
scientific evidence can become insufficient within  the meaning of Article 5.7 in the presence of 
international standards. 
7.573  The Panel does not believe that the issue of the possibility or not to make a quantitative  
estimate of the risk to consumers constitutes a subject on which a discussion of whether "relevant 
scientific evidence is insufficient" is needed. The Pane l recalls in this respect that the standard applied 
by the Appellate Body to determine whether rele vant scientific evidence is insufficient is that: 
" 'relevant scientific evidence' will be 'insu fficient' 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 ."670 
7.574  Moreover, we note that the Appellate Body considered that Article 5.1 does not require that 
risk assessments be quantitative, but that qualitati ve risk assessments are also compatible with 
Article 5.1.671  We recall in this regard that Codex itself does not necessarily require the performance 
of quantitative risk assessments.672 
7.575  We also deem it important to recall that, in Japan – Agricultural Products II , the Appellate 
Body stated that: 
"Article 5.7 allows members to adopt provisional SPS measures '[i]n case where 
relevant scientific evidence is insufficient'  and certain other requirements are fulfilled. 
Article 5.7 operates as a qualified exempti on from the obligation under Article 2.2 not 
to maintain SPS measures without sufficient scientific evidence.  An overly broad and flexible interpretation of that obliga tion would render Article 5.7 meaningless."
673 
7.576  The European Communities also refers to paragraphs 194 (on minority scientific views) and 
205 (on Article 5.2 and good vete rinary practices) of the report of the Appellate Body in EC – 
Hormones . 
7.577  We have already addressed above674 the question of the treatment of minority views among 
experts and do not find it necessary to come back on this matter.  As far as the second issue is 
                                                      
669 Canada's first written submission, paras. 117-118. 
670 Appellate Body Report on Japan – Apples , para. 179 (emphasis added). 
671 Appellate Body Report on  EC – Hormones , para. 187. 
672 Working Principles for Risk Analysis for Application within  the Framework of the Codex 
Alimentarius, para. 20. 
673 Appellate Body Report on Japan – Agricultural Products II  , para. 80. 
674 See para. 7.411 above. WT/DS321/R 
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  concerned, we note that, as reca lled by the Appellate Body in EC – Hormones , it is also appropriate 
for the European Communities to consider situations of misuse: 
"… 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 hum an 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 substances and from control problems need 
to be, or should be, evaluated by risk asses sors 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 evaluation 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 …"
675 
7.578  The above statement was made in relation to  the performance of a risk assessment under 
Article 5.1 and 5.2 of the SPS Agreement .  We recall that Article 5.7 is applicable when relevant 
scientific evidence is not sufficient to undertake a ri sk assessment in conformity with Article 5.1. 
Whether instances of misuse or abuse in the administ ration of hormones exist or not is not as such a 
scientific issue likely to make a risk assessment w ithin the meaning of Article 5.1 and Annex A(4) of 
the SPS Agreement  impossible.  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 . 
(iv) When will "relevant scientific evidence" be deemed "insufficient"? 
Effect of the level of protection on the considera tion of the insufficiency of relevant scientific 
evidence under Article 5.7  
7.579  According to the European Communities , whether a risk assessment can reach a definitive 
conclusion depends not only on the da ta available but also on how a risk assessment has been framed 
by the risk manager.676  The European Communities argues that a Member may disagree with the risk 
assessment underlying an international standard for sci entific reasons and, in particular, on the issue 
of whether the scientific evidence relied upon is su fficient.  Such a disagreement may result from the 
fact that in order to meet a higher level of prot ection, a Member may require more information than 
that provided.677  The European Communities argues that th e evidence which serv ed as the basis for 
the 1988 and 1999-2000 JECFA evaluations is not su fficient "to perform a definitive risk assessment 
within the meaning of Article 5.7, in particular by the WTO Members applying a high level of health protection of no risk from exposure to unnecessary a dditional residues in meat of animals treated with 
hormones for growth promotion".
678  
7.580  Canada  is of the view that there is simply no b asis for the EC approach in the text of the 
SPS Agreement  or the relevant WTO jurisprudence.  According to Canada, the European 
                                                      
675 Appellate Body Report on EC – Hormones , para. 206.  See also Appellate Body Report on Japan – 
Apples , para. 179. 
676 EC's oral statement at the second panel meeting, para. 22. 
677 EC's replies to Panel questions after the firs t substantive meeting, question 72, Annex B-1, 
para. 266. 
678 EC's second written submission, para.143; EC's replies to Panel questions after the first substantive 
meeting, question.31, Annex B-1, paras. 167-172.  WT/DS321/R 
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  Communities does not contest that these five hormon es have been the subject of several scientific 
assessments by reputable regulatory agencies and in ternational scientific committees such as JECFA. 
However, the European Communities seems to be at  a loss to explain why in the face of these risk 
assessments it has concluded that it is unable to perfo rm an adequate assessment of risk on these five 
hormones.  The European Communities discounts the va lid scientific findings of JECFA in respect of 
the safety of these hormones on the basis that the JECFA findings do not meet the European 
Communities' chosen level of protection. In doi ng so, the European Comm unities confuses the notion 
of the "insufficiency", or in the present case the "suffi ciency", of the relevant scientific evidence with 
a WTO Member's "autonomous right"679 to establish its own appropriate level of protection as set out 
in Article 3.3 of the SPS Agreement . 
7.581  In Canada's opinion the ability to conduct a risk assessment cannot hinge on a Member's 
appropriate level of protection. Such an approach undermines the basic logic of the SPS Agreement as 
reflected in Articles 2.2, 3.3, 5.1 and 5.7 of the Agreement. Article 3.3 requires that where a Member 
introduces a measure that results in a higher level of  SPS protection than that implied by the relevant 
international standards, it must base its measure on a risk assessment. 
7.582  Canada  considers that a Member cannot refu se to consider certain relevant scientific 
evidence in its evaluation of whether or not the body  of available scientific evidence is sufficient to 
allow the performance of a risk assessment on the basis that this eviden ce does not achieve the 
Member's chosen level of protection. Such an appr oach would allow Members to arbitrarily set their 
level of protection so high that they could effectively exclude from the pool of relevant scientific evidence any evidence that does not m eet their chosen level of protection. This does not conform with 
the test set out by the Appellate Body with rega rd to the sufficiency of the "relevant scientific 
evidence" under Article 5.7.
680 
7.583  The Panel first notes that the European Communities refe rs to the fact that the evidence is not 
sufficient to perform a "definitiv e risk assessment".  However, the European Communities nowhere 
defines what it means by a "definiti ve risk assessment".  The Panel r ecalls the definition of adequate 
risk assessment proposed by the European Communities in EC – Approval and Marketing of Biotech 
Products : "one which has been 'delivered by a reput able source, [which] unequivocally informs the 
legislator about what the risk is with a sufficient degree of precision, and [which] has withstood the 
passage of time and is unlikely to be revised'."681  It is unclear to the Panel whether this is what the 
European Communities refers to in  this case as a "definitive risk assessment".  The Panel would like 
to specify that there is no obligation under the SPS Agreement  to perform a definitive  risk assessment 
for that risk assessment to be valid under Ar ticle 5.1.  Moreover, the Panel doubts that a definitive  risk 
assessment can in practice ever be performed, since new evidence becomes available and risk 
assessments may need to be reviewed and update d accordingly, or else the measure based on these 
risk assessments will have to be adjusted to the evoluti on of the scientific evidence.682  The Panel 
understands the terms "based on an assessment, as appropriate to the circumstances" to suggest that 
the link between the SPS measure adopted by a Memb er and the risk assessment on which it is based 
may evolve depending on the circumstances, thus implying that Article 5.1 does not require a 
definitive risk assessment.  This is also confirmed by the fact that risk assessments do not have to be 
"monolithic" as recalled by the Appellate Body in EC – Hormones .683  In any event, the criterion 
allowing the adoption of sanitary measures on the b asis of available pertinent information under 
Article 5.7 is that "relevant scientific evidence is  insufficient" to permit the performance of a risk 
assessment as required under Article 5.1 and Annex A( 4), not that the risk assessment to be performed 
                                                      
679 Appellate Body Report on EC – Hormones , para. 172. 
680 Canada second written submission, para. 128. 
681 Panel Report on EC – Approval and Marketing of Biotech Products , para. 7.3238. 
682 See Panel Report on EC – Approval and Marketing of Biotech Products , paras. 7.3239-7.3240. 
683 Appellate Body Report on EC – Hormones , para. 194. WT/DS321/R 
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  pursuant to Article 5.1 be a definitive one.684 The Panel is of the view that, by suggesting that a risk 
assessment be definitive, the European Communities actually di sregards the Appellate Body 
interpretation mentioned above and seeks to im pose a higher threshold for compliance with 
Article 5.1, or a lower one to meet the conditions of  Article 5.7.  However, the Panel does not believe 
that this approach is supported by Artic le 5.1, Annex A(4) or Article 5.7.   
7.584  The Panel also notes the EC view that, in determ ining whether the relevant scientific evidence 
is insufficient, within the meaning of Article 5.7, the Panel should take into account the level of health 
protection applied by the Member concerned.  Mo re particularly, the European Communities  argue 
that, when the level of health protection of a Member  is particularly high and the body of evidence is 
in the process of moving from a state of sufficiency to a state of insufficiency, that Member should 
not be required to demonstrate positiv ely the existence of a clear harm. 
7.585  Regarding the issue of whether the level of h ealth protection of a particular Member should 
play a role in its assessment of whether the relevant  scientific evidence is insufficient, the Panel notes 
that the EC level of health protection is that of " no (avoidable) risk, that is a level of protection that 
does not allow any unnecessary additi on from exposure to genotoxic chemical substances that are 
intended to be added deliberately to food."685 
7.586  We recall that the Appellate Body in Japan – Apples  stated that relevant scientific evidence 
will be insufficient within the meaning of Article 5. 7 if the body of availabl e scientific evidence does 
not allow, in quantitative or qualitative terms, the pe rformance of an adequate assessment of risks as 
required under Article 5.1 and as defined in Annex A to the SPS Agreement .686 
7.587  The terms of Article 5.1 and Annex A to the SPS Agreement  and, in particular, the definition 
of "risk assessment" do not indicate that a Member's level of protection is pertinent to determine 
whether a risk assessment can be performed or not.  We agree with the Panel in EC – Approval and 
Marketing of Biotech Products  when it states that: 
"[W]e are not convinced that the protection goa ls pursued by a legislator are relevant 
to such a determination. The protection goals of a legislator may have a bearing on 
the question of which risks a Member d ecides to assess with a view to taking 
regulatory action, if necessary.  And a le gislator protection goals are certainly 
relevant to the determination of the measure  ... to be taken for achieving a Member's 
level of protection against risk.  Yet there is no apparent link between a legislator's 
protection goals and the task of assessing th e existence and magnitude of potential 
risks."687   
7.588  We note that sufficient scientific evidence is what is needed to make a risk assessment.  The 
assessment whether there is sufficient scientific ev idence or not to perform a risk assessment should 
be an objective process.  The level of protecti on defined by each Member may be relevant to 
                                                      
684 The Panel notes in this respect that in Australia – Salmon, the Appellate Body stated that:  
 
"We might add that the existence of unknown and uncertain elements  does not justify a 
departure from the requirements of Articles 5.1, 5.2 and 5.3, read together with paragraph 4 of 
Annex A, for a risk assessment."(Appellate Body Report on Australia – Salmon , para. 130). 
 
The Panel also notes Dr. Boisseau's remark, that "it is  always possible to ask for more data in order to 
clarify more issues so that the will to eliminate any sc ientific uncertainty could result in an endless assessment 
process". Replies by the scientific experts to Panel questions, para. 452, Annex D. 
685 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 69. 
686 Appellate Body Report on Japan – Apples , para. 179. 
687 Panel Report on EC – Approval and Marketing of Biotech Products , para. 7.3238.  WT/DS321/R 
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  determine the measure to be selected to address the assessed risk, but it should not influence the 
performance of the risk assessment as such.  
7.589  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. 
7.590  A risk-averse Member may be inclined to ta ke a protective position when considering the 
measure to be adopted.  However, the determinatio n of whether scientific evidence is sufficient to 
assess the existence and magnitude of a risk mu st be disconnected from the intended level of 
protection.   
7.591  This is not to say, however, that we disagree with the European Communities that when the 
body of evidence is in the process of moving from a st ate of sufficiency to a state of insufficiency a 
Member should not be required "to demonstr ate positively the existence of clear harm."688  In fact, 
even when the scientific evidence is  sufficient, a Member is not required, under the provisions of the 
SPS Agreement , to "demonstrate positively the existence of a clear harm".  Rather, the objective of a 
risk assessment is to evaluate the potential for harm to occur unde r certain circumstances (e.g., from 
the consumption of a foodstuff containing certain contaminants).  
Can relevant scientific evidence become  "insufficient"?  
7.592  In reply to a question from the Panel, Canada  argues that Article 5.7 applies when "no risk 
assessment can be made at all" either because th ere is simply not enough evidence to conduct a risk 
assessment, or when the ev idence available is insufficiently sp ecific to conduct a risk assessment as 
defined in Annex A of the SPS Agreement .689 
7.593  Canada adds that it is theoretically possible th at scientific evidence judged to be sufficient to 
undertake a risk assessment at a particular point in time may be considered to be insufficient to 
conduct a risk assessment for the same purpose several y ears later. For example, this could be due to a 
change in the basic understanding of a biological event that is triggered by the chemical under assessment, new scientific data that identify new adve rse effects or adverse effects at lower exposure 
levels. New sources of exposure could also trigger the need to reassess the adequacy of the risk 
assessment. 
7.594  Canada considers that it would not be the number of scientific studies conducted in the 
intervening years that would determine whether a new risk assessment was necessary but rather the 
nature of the studies. For example, if new residue  studies (i.e. an analysis of the chemical and 
significant metabolites in food) were carried out then this would require minimally an exposure 
reassessment and possibly a risk characterization reassessment. 
690 
7.595  The European Communities  considers that Article 5.7 of the SPS Agreement  is applicable 
not only when no risk assessment can be made at all,  but also when the lat est scientific evidence from 
any credible and objective source raises doubts or puts  into question the previously held scientific 
opinion about the safety or dangerous nature of the substance in question.691  The European 
Communities adds that the evid ence assessed by the SCVPH, while  inconclusive in terms of 
demonstrating a risk, does nonetheless point to the possible occurrence of certain adverse effects, 
                                                      
688 EC's second written submission, para. 149. 
689 Canada's replies to Panel questions after the first substantive meeting, question 67, Annex B-2. 
690 Canada's replies to Panel questions after the first substantive meeting, question 73, Annex B-2 
691 EC's replies to Panel questions after the first substantive meeting, question 67, Annex B-1. WT/DS321/R 
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  which invalidate or put into serious doubts prev iously held assumptions about the safety of these 
hormones by the defending parties and Codex/JECFA.692  The European Communities concludes that 
serious doubt may exist when the pertinent availabl e evidence is contradictory, inconclusive or 
incomplete.693  To guard against potential abuses, th e new evidence should not be arbitrary but 
credible and should show that there is a genui ne scientific disagreement identified in a risk 
assessment. 
7.596  The European Communities further argues that, due to the dynamic nature of scientific 
knowledge,  a risk assessment that may at one point in tim e have been based on sufficient scientific 
evidence may need to be reviewed when new scientific evidence becom es available.  In addition, new 
international risk assessment standards may become av ailable that have to be taken into account in 
new risk assessments.694    
7.597  First, the Panel notes that parties agree to the fact  that scientific evidence which was 
previously deemed sufficient could subsequently beco me insufficient.  Both parties agree that there 
could be situations where new studies can affect th e conclusion of existing risk assessments.  Canada 
considers, however, that in the case at hand the existence of such new studies would not make the 
scientific evidence "insufficient" for conducting such an assessment. 
7.598  The Panel agrees with the parties 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 ri sk assessment is unsettled by new studies which do not constitute 
sufficient relevant scientific eviden ce as such to support a risk assess ment but are sufficient to make 
the existing, previously relevant  scientific evidence insufficient.695 
7.599  Indeed, nothing in Article 5.7 prevents such an interpretation.  We also note in this respect 
that Article 2.2 foresees such a possibility when it mentions that sanitary measures must not be 
"maintained without sufficient scientific evidence ex cept as provided for in paragraph 7 of 
Article 5."696  The use of the word "maintained" read together with the reference to Article 5.7 
suggests the possibility of an evolution from a situ ation of sufficient evidence to perform a risk 
assessment to one where, in substance, a risk assessment can no longer be performed. 
7.600  The Panel notes in this respect that a procedur e is available for Codex members and observers 
to request the inclusion of a particular compound fo r evaluation or re-evaluation on a "priority list" 
that the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) communicates to JECFA.
697   The European Communities refers to an exchange of letters between the European 
Commission and Codex and JECFA regarding a postpone ment of the re-evaluation due to be carried 
out by JECFA in 1999.698  The European Communities seems to allege that there was a commitment 
from Codex and JECFA to re-evaluate the hormones at issue once the studies commissioned by the 
European Communities would be available.699  However, this explanation was not confirmed by 
                                                      
692 EC's second written submission, para. 143. 
693 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 43. 
694 EC's replies to Panel questions after the firs t substantive meeting, question 73, Annex B-1, 
paras. 268-273. 
695 See also Article 2.2 which provides that a sanitary measure must not be maintained without 
sufficient scientific evidence except as provided for in paragraph 7 of Article 5.  This seems to imply that the 
information relied upon under Article 5.7 may include evidence, including relevant scientific evidence and not 
merely information, as long as that evidence remains insufficient. 
696 Emphasis added. 
697 See statement of Dr. Miyagishima, Codex represen tative, Transcript of the Panel meeting with the 
experts, Annex G, paras. 523-524. 
698 Exhibit EC-63. 
699 EC's statement, Transcript of the Panel meeting with the experts, Annex G, para. 527.  WT/DS321/R 
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  Codex or JECFA.  From the information communi cated by the representatives of Codex and JECFA 
at the meeting of the Panel with scientific expert s, it appears on the cont rary that the European 
Communities never actually requested Codex or JECF A to re-evaluate any of the hormones for which 
risk assessments had been carried out by JECFA and standards adopted by Codex.  The representative 
of Codex stated that there was no record in the re ports of the CCRVDF of proposals, either from the 
European Communities or from Memb er States of the European Comm unities, to include the five 
substances at issue in the priority  list for re-evaluation by JECFA.700  The representative of Codex 
added that, even at the latest session of the CCRV DF in 2006, no such request had been made.701  
7.601  Second, since the present situation is one where it is alleged that existing relevant scientific 
evidence has become insufficient, it seems important  to determine which circumstances could make 
such existing evidence insufficient. 
7.602  The Panel recalls that, in Japan – Apples , the Appellate Body found that: 
" '[R]elevant scientific evidence' will be  "insufficient" within the meaning of 
Article 5.7 if the body of available scien tific 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 .  Thus, the 
question is not whether there is sufficient evidence of a general nature or whether 
there is sufficient evidence related to a speci fic aspect of a phytosanitary problem, or 
a specific risk.  The question is whether th e relevant evidence, be it 'general' or 
'specific', in the Panel's parlance, is sufficient to permit the evaluation of the likelihood of entry, establishment or spread  of, in this case, fire blight in Japan."
702 
7.603  We also note that in EC – Approval and Marketing of Biotech Products , the panel stated that: 
"[I]t must be determined on a case-by-case basis whether the body of available 
scientific evidence is insufficient to perm it the performance of a risk assessment." 
7.604  We agree with the EC – Approval and Marketing of Biotech Products  panel and we will base 
our assessment on the evidence submitted by the parties in this case, havi ng regard to the views of the 
experts on each issue. 
7.605  This said, the Panel believes that it needs to  determine under which circumstances relevant 
scientific evidence may more particularly be deemed "insufficient" in this case. 
7.606  The Panel first reads the first sentence from the extract of the Appellate Body report in Japan 
– Apples  quoted above as meaning that relevant scientific  evidence will be deemed insufficient within 
the meaning of Article 5.7 if the relevant scientif ic evidence does not make it possible to complete a 
risk assessment on which a san itary measure can be based in substance .  It is always possible to 
perform the four successive steps of  a risk assessment as defined by Codex and ultimately reach the 
conclusion that relevant scientific evidence is in sufficient (as the European  Communities did in the 
case of the five hormones in respect of which it appli es a provisional ban).  However, the fact that the 
Codex four steps can be formally completed does not mean that such a process is equated with a risk 
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement . There will be a 
risk assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement  when the 
                                                      
700 Statement by Dr. Miyagishima, Codex representative, Transcript of the Panel meeting with the 
experts, Annex G, para. 524. 
701 Dr. Miyagishima, Codex representative, Transcript of the Panel meeting with the experts, Annex G, 
para. 529. 
702 Appellate Body Report on Japan – Apples , para. 179. WT/DS321/R 
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  assessor has analysed fully the poten tial for the identified adverse eff ects to arise from the presence of 
the substance at issue in food, beve rages, or foodstuffs.  We believe that this was the intention of the 
Appellate Body when it used the term adequate703 in "adequate assessment of risks as required under 
Article 5.1 and as defined in Annex A to the  SPS Agreement ."  This is confirmed by the second 
sentence of Article 5.7 which provides that "Member s shall seek to obtain the additional information 
necessary for a more objective assessment  of risk."704  In other words, Article 5.7 will apply in 
situations where, in substance, the relevant sci entific evidence does not allow the completion of an 
objective evaluation of the potential for adverse effe cts on human or animal health arising from the 
presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or 
feedstuffs. 
7.607  While this gives a general idea of the circum stances under which Article 5.7 may be invoked, 
we should strive to ascertain more precisely the scope of "insufficient", if possible. In doing that, we 
should keep in mind that Article 5.7 operates as a qualified exemption from the obligation under 
Article 2.2 not to maintain SPS measures without sufficient scientific evidence and that an overly broad and flexible interpretation of that obligation would render Article 5.7 meaningless.
705 
7.608  As a first step, we note that, in Japan – Apples , the Appellate Body seemed to consider that 
relevant  scientific evidence is insufficient if, irrespec tive of the quantity of evidence available, it has 
not led to reliable  or conclusive  results.706 It also seems that evidence providing unreliable or 
inconclusive results should not be confused with  "scientific uncertainty", as it appears from the 
following Appellate Body statement in Japan – Apples : 
"The application of Article 5.7 is trigge red not by the existence of scientific 
uncertainty, but rather by the insufficiency  of scientific evidence.  The text of 
Article 5.7 is clear:  it refers to 'cases where relevant scientific evidence is 
insufficient', not to 'scientific uncer tainty'.  The two concepts are not 
interchangeable."707 
7.609  We understand this statement to mean that th e existence of scientific uncertainty does not 
automatically amount to a situation of insufficiency of relevant scientific evidence.  In other words, 
the fact that a number of aspects of a given scien tific issue remain uncerta in may not prevent the 
performance of a risk assessment.  First, we shoul d exclude theoretical uncertainty, which is the 
uncertainty that always remains because science can never provide absolute cer tainty about the safety 
of a given substance.  In EC – Hormones , the panel and the Appellate Body concurred in agreeing that 
theoretical uncertainty was not the kind of risk to be assessed under Article 5.1.708 In the Panel's view, 
theoretical  uncertainty therefore should also not determine the applicability of Article 5.7. 
7.610  Second, we note that in EC – Hormones , the Appellate Body stated that the presence of 
divergent views on an issue could be a form of scientific uncertainty.709 We nevertheless note that 
                                                      
703 "commensurate in fitness, sufficient, satisfactory" ( The Shorter Oxford English Dictionary  (5th ed., 
2002), p. 26). 
704 Emphasis added. 
705 Appellate Body Report on Japan – Agricultural Products II , para. 80. 
706 Appellate Body Report on Japan – Apples , para. 185: 
 
"We do not read the Panel's interpretation as ex cluding cases where the available evidence is 
more than minimal in quantity, but has not led to reliable or conclusive results." 
 
707 Appellate Body Report on Japan – Apples , para. 184. 
708 Appellate Body Report on EC – Hormones , para. 186. 
709 Appellate Body Report on EC – Hormones , para. 194.  WT/DS321/R 
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  scientific uncertainty may be factored into the conc lusions of the risk assessment.  We find support for 
this conclusion in the following comment of the Appellate Body in Australia – Salmon :  
"We might add that the existence of unknown and uncertain elements does not justify 
a departure from the requirements of Articles 5.1, 5.2 and 5.3, read together with paragraph 4 of Annex A, for a risk assessment."
710 
7.611  This issue was further addressed by the panel in EC – Approval and Marketing of Biotech 
Products , which acknowledged that the conclusions of a risk assessment may not be free from 
uncertainties or other constraints even though ther e was sufficient relevant scientific evidence to 
perform the risk assessment.711  The panel, in agreement with the Appellate Body in EC – Hormones , 
found "that such uncertainties may be legitimately ta ken into account by a Member when determining 
the SPS measure, if any, to be ta ken" and that the scientific uncer tainties present in a risk assessment 
may support a range of possible measures and within  the range of measures reasonably supported by 
the risk assessment and consistent with other applicable SPS Agreement  provisions, the Member was 
entitled to choose one that best protects human health and/or the environment.712  As recalled by the 
panel in EC – Approval and Marketing of Biotech Products , Members were also justified in taking 
into account factors like a limited body of releva nt scientific evidence, assumptions and other 
constraints that would affect the level of confidence in the risk assessment: 
"We consider that if there are factors which affect scientists' level of confidence in a 
risk assessment they have carried out713, a Member may in principle take this into 
account in determining the measure to be applied for achieving it s appropriate level 
of protection from risks.714  Thus, there may conceivably be cases where a Member 
which follows a precautionary approach, an d which confronts a risk assessment that 
identifies uncertainties715 or constraints, would be justified in applying (i) an SPS 
measure even though another Member might not decide to apply any SPS measure on 
                                                      
710 Appellate Body Report on Australia – Salmon , para. 130. 
711 Panel Report on EC – Approval and Marketing of Biotech Products,  para. 7.1525. 
712 Panel Report on EC – Approval and Marketing of Biotech Products,  para. 7.1525. 
713 (footnote original ) E.g., a limited body of relevant scientific evidence may be such a factor. 
714 (footnote original ) This view is consistent with risk asse ssment techniques established by relevant 
international organizations.  For instance, the Working Principles for Risk Analysis for Application in the 
Framework of the Codex Alimentarius state that "[t]he report of the ri sk assessment should indicate any 
constraints, uncertainties, assumptions and their impact on  the risk assessment.  Minority opinions should also 
be recorded.  The responsibility for resolving the impact of uncertainty on the risk management decision lies 
with the risk manager, not the risk assessors".  Codex Alimentarius Commission, Working Principles for Risk 
Analysis for Application in the Framework of the Codex Alimentarius (adopted in June/July 2003), Section III, 
Codex Procedural Manual, 14th edition, 2004, para. 25.  Along similar lines, the Codex  Principles for the Risk 
Analysis of Foods Derived from Modern Biotechnology state that "[r]isk managers should take into account the 
uncertainties identified in the risk assessment and implement appropriate measures to manage these 
uncertainties".  Codex Alimentarius Commission, Principles for the Risk Analysis of Foods Derived from 
Modern Biotechnology  (adopted in June/July 2003), CAC/GL 44-2003, para. 18.  Similarly, the IPPC's ISPM 
#11 (2001) states in relevant part that "[t]he uncertainty noted in the assessments of economic consequences and 
probability of introduction should also be considered and included in the selection of a pest management 
option".  IPPC, ISPM #11: Pest Risk Analysis for Quarantine Pests , April 2001, para. 3.  The quoted passage 
stayed the same in the 2004 version of ISPM #11, wh ich applies specifically to living modified organisms. 
715 (footnote original ) We are not referring here to the theoretical uncertainty which inevitably remains 
because science can never provide absolute certainty th at a product will never have adverse effects on human 
health or the environment.  The Appellate Body has made it clear that this theoretical uncertainty is not the kind 
of risk which is to be assessed under Article 5.1.  Appellate Body Report on EC – Hormones , para. 186.   WT/DS321/R 
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  the basis of the same risk assessment, or (ii)  an SPS measure which is stricter than the 
SPS measure applied by another Member to address the same risk".716 
7.612  The panel explicitly recognized that, even thoug h scientific uncertainty existed, there could 
still be sufficient scientific eviden ce to perform a risk assessment.717 
7.613  We note in this respect the comments of Dr. Boisseau and Dr. Boobis before the Panel on 
how scientific uncertainty is addressed in risk assessment.718  
                                                      
716 Panel Report on EC – Approval and Marketing of Biotech Products , para. 7.3065. 
717 Panel Report on EC – Approval and Marketing of Biotech Products,  para. 7.1525. 
718 See replies of Dr. Boisseau and Dr, Boobis to question 12 of the Panel, Annex D, paras. 123-128. 
 
Dr. Boisseau expressed the following views:  
"In assessing the risk for human health associ ated with the exposure to veterinary drug 
residues, JECFA adresses the scientific uncertainty by using the safety factors listed above in 
my reply to the question n°8 describing, among others, how JECFA builds a margin of safety 
into its final recommendations. 
For the hormonal growth promoters, JECFA has considered that, given the quality and the 
quantity of the available data, it was possible to carry out a complete quantitative risk 
assessment.  For establishing ADIs and MRLs fo r the three synthetic hormones, melengestrol, 
trenbolone and zeranol, JECFA has implemented the usual procedure regarding the safety 
factors.  For the three natural hormones, oestradiol-17 β, progesterone and testosterone, 
JECFA has decided that the margin of safety deriving from the values of the established ADIs 
and from a maximum estimated intake of residue was such that it was not necessary to set up 
MRLs. 
For oestradiol-17 β, the European Communities did not consid er any scientific uncertainty as it 
decided that it was not possible, for reason of principle, to establish an ADI for a genotoxic 
compound.  For the five other hormones at issue, the European Communities did not really 
consider any scientific uncertainty as it decided that the available data were too limited to 
allow a complete quantitative risk assessment to be carried out." 
 
Dr. Boobis mentioned the following: 
 
"Scientific uncertainty is dealt with in a variety of ways in risk assessment.  ... 
 
One way of dealing with uncertainty is to defa ult to the worst case in the absence of evidence 
to the contrary.  Hence, the most sensitive relevant endpoint in the most sensitive species is 
used as the basis of the risk assessment.  In extrapolating to humans a default factor of 10 is 
used to allow for species differences, which a ssumes that humans are more sensitive than the 
experimental species.  A further factor of 10 is included for interindividual differences.  These 
differences may be due to gender, genetics, life stage or other factors.  However, to some 
extent such differences have already been taken into account in the choice of endpoint, as this 
will usually represent the most sensitive lifestage, gender and to some extent genetics by using 
data from the most sensitive species.  Where th ere are additional uncertainties, such as no 
NOEAL or the absence of a non-critical study, an  additional safety factor will be included, 
and this is almost always conservative, as when the data gaps have been completed, the 
appropriate safety factor is almost always less th an that used to account for these data gaps.  
The residue may be assumed to be all as active as the most active moiety, which is almost 
always a conservative assumption.  Dietary intake is based on conservative data for food 
consumption.  It is also assume d that all meat that could contai n veterinary drug residue will 
contain the residue and that this will be present at the high end of the range (MRL or other 
appropriate level).  In respect of the ADI, the assumption is that intake will be at this high 
level for a lifetime, when in rea lity there will be occasions when  little or no meat is consumed  WT/DS321/R 
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  7.614  We find further support for this position in the view of the Appellate Body as expressed in 
Japan – Apples  that whether relevant scientific evidence is  insufficient must be assessed "not in the 
abstract, but in the light of a particular inquiry".719 
7.615  While we agree that under certain circumstan ces what was previous ly sufficient evidence 
could become insufficient, we do not believe that the existence of scientific  uncertainty means that 
previously sufficient evidence has in fa ct become insufficient, nor should it ipso facto  justify the 
applicability of Article 5.7 of the SPS Agreement .  
Relationship between insufficiency of the evid ence and the existence of an international 
standard  
7.616  Canada  considers that it is essential to take intern ational standards into consideration when 
determining whether relevant scientific evidence is insufficient. More important than the numerical 
standard is the basis, support or risk assessment fo r that international standard. For example, it is 
recognized that JECFA only allocates an ADI for a food additive or veteri nary drug under review 
when JECFA considers that its scientific data b ase is complete and that there are no outstanding 
scientific issues.720 
7.617  According to Canada, Article 5.7 allows Members to adopt provisional measures in a 
situation where there is insufficient scientific ev idence to conduct a risk assessment. However, it does 
not give Members carte blanche  in this area. The provisional measure must be based on "available 
pertinent information", including th at from relevant international or ganizations and measures of other 
WTO Members. Where a relevant international or ganization has adopted standards on a particular 
SPS issue, it makes it extremely diffi cult for a Member to argue that there is insufficient scientific 
evidence to conduct a risk assessment , because the existence of an inte rnational standard implies that 
sufficient scientific evidence exists to complete a risk assessment. The burden rests with the European 
Communities in this case to demonstrate that, desp ite the adoption of international standards by 
Codex regarding the hormones at issue, the scientific  evidence is insufficient to allow it to conduct a 
risk assessment.721 
                                                                                                                                                                     
or that which is consumed contains less or ev en no residue.  In their risk assessment of the 
hormones, JECFA applied all of these approaches to dealing with the uncertainty. 
 
In dealing with scientific uncertainty much depends on the expert judgment of the risk 
assessor.  Issues such as biological cohere nce, whether effects ar e considered compound 
related, relevance to humans, the reliability of model systems at predicting effects in vivo all 
impact on the interpretation of the data.  Within the EU, it is clear that there are also 
differences in the interpretation of data, as illustrated by the differing conclusions of the 
CVMP (1999) and the SCVPH (1999).  In part, the EC assessment of the hormones did not go 
as far as including some of the considerations  for uncertainty used by JECFA because of the 
conclusion that there was insufficient informati on to determine whether there was a threshold 
for the carcinogenic effects.  However, for some of the compounds this was based on the 
results of a small number of non-standard tests of genotoxicity, with equivocal of very weak 
responses.  It is not clear whether the EC app lied a weight of evidence approach to evaluating 
the genotoxicity of all of the compounds, taking account the totality of the available data, as 
was the case by JECFA." 
 
719 Appellate Body Report on Japan – Apples , para. 179.  See also Panel Report on EC – Approval and 
Marketing of Biotech Products , where the Panel "agree[ed] that it must be determined on a case-by-case basis 
whether the body of available scientific evidence is insu fficient to permit the performance of a risk assessment." 
(para. 7.3238). 
720 Canada's replies to Panel questions after the first substantive meeting, question 73, Annex B-2. 
721 Canada's replies to Panel questions after the first substantive meeting, question 72, Annex B-2. WT/DS321/R 
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  7.618  The European Communities  argues that a Member may disagree with the risk assessment 
underlying an international standard for scientific r easons and, in particular, on the issue of whether 
the scientific evidence relied upon is sufficient.  Su ch a disagreement may result from the fact that in 
order to meet a higher level of protection, a Member  may require more information than that provided 
for the development of the international standard.722   
7.619  The European Communities further argues that th e relevant Codex standards on four of the 
five provisionally banned hormones are not capable of achieving the chosen high level of protection 
of the European Communities.  According to th e European Communities, the overall evidence and 
recent scientific developments have now "tipped th e balance against the previously held assumption 
(by the defending parties and Codex/JECFA) that residues of these hormones in meat from animals treated for growth promotion pose no risk to human  health". The European  Communities argues that 
the evidence which served as the b asis for the 1999-2000 JECFA eval uations 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 level of health pr otection of no risk from exposure to unnecessary 
additional residues in meat of animals trea ted with hormones for growth promotion".
723 
7.620  Referring to the way in which JECFA addresses sci entific uncertainty through safety factors, 
the European Communities states that there is "almos t universal agreement that this approach is not 
scientifically correct".  According to the European  Communities, a state of uncertainty may result 
from a number of factors including lacking, incomplete  or contradictory data; the quality of the data is 
more important than the quantity.  An issue thought  to be clear can become uncertain as more data 
become available.  The European Communities argues that if uncertainty is understood in this sense, it 
cannot be addressed through safety factors, especially  for countries applying a high level of health 
protection.724 
7.621  Having regard to the arguments of the parties, the Panel deems it important to recall that 
international standards, guidelines or recommendations  exist with respect to four out of the five 
hormones at issue in this section.725 The Panel notes in this respect the important role given to 
international standards, guidelines or recommendations by the SPS Agreement .726  We also note that 
Article 3.2 of the SPS Agreement  reads as follows: 
                                                      
722 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 266. 
723 EC's second written submission, paras. 143; EC's re plies to Panel questions after the first substantive 
meeting, question 31, Annex B-1, paras. 167-172. 
724 EC's comments on expert replies to Panel questions, question 12, Annex F-1. 
725 For melengestrol acetate, the situation is as follo ws: JECFA concluded its evaluation of MGA at its 
sixty-sixth meeting in Rome on 22-28 February 2006 and proposed MRLs.  These MRLs were considered by CCRVDF in 2006, but because there was no consensus for their adoption, the CCRVDF agreed to consider 
them again at its session in 2007. (For more detail, incl uding references to relevant Codex and JECFA reports, 
see Annex E-1, p. 103 and Annex E-2, p. 116).  Annex A, paragraph 3 of the SPS Agreement  defines 
international standards, guidelines and recommendations for food safety as follows: 
 
"International standards, guidelines and recommendations  
 
(a) for food safety, the standards, guidelines and recommendations established by the Codex 
Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, 
methods of analysis and sampling, and codes and guidelines of hygienic practice". 
726 See Article 3.1 of the SPS Agreement , which reads as follows: 
 
"To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base 
their sanitary or phytosanitary measures on internati onal standards, guidelines or recommendations, where they 
exist , except as otherwise provided for in this Agreement, and in particular in paragraph 3." (Emphasis added)  WT/DS321/R 
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  "Sanitary or phytosanitary measures whic h conform to international standards, 
guidelines or recommendations shall be deem ed to be necessary to protect human, 
animal or plant life or health, and presume d to be consistent with the relevant 
provisions of this Agreement and of GATT 1994." 
7.622  The presumption of consistency of measures conf orming 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 undert ake the appropriate risk assessments. 
7.623  As mentioned above, the Panel is also mindful th at science continuously evolves.  It cannot be 
excluded that new scientific evidence or information call into question existing evidence.  Likewise, it 
cannot be excluded that different risk assessments reach  different interpretations of the same scientific 
evidence. 
7.624  Yet, some meaning has to be given to the role assigned by the SPS Agreement  to international 
standards, guidelines and recommendations, even though the rights of Members under Article 3.3 
should be acknowledged727, and this should not lead to the im position of a special or generalized 
burden of proof upon the European Communities.728 
7.625  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 become insuffi cient by determining whether the European 
Communities has produced any evidence of some sufficient change in the scientific knowledge so that 
what was once sufficient to perform an adequate risk assessment has now become insufficient (i.e. 
"deficient in force, quality or amount")729.  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 successfully claim that re levant scientific evidence has become insufficient .  Indeed, more 
studies can always be performed and there can always be more evidence.  We note in this regard that 
the European Communities shares our position in its second written submission, where it makes a 
"brief description of insufficiency of pertinent  scientific information for all five hormones (except 
oestradiol-17 β)".  We interpret the use of the word "pertin ent" and not "relevant" as in Article 5.7 as 
meaning that the European Comm unities agrees that not any insufficiency of relevant scientific 
evidence would make the performance of a risk asse ssment impossible.  Indeed, "insufficiencies in the 
evidence" does not necessarily equal "insufficient evidence" to do a risk assessment, as recalled 
above.  Moreover, as mentioned by the Appellate Body in EC – Hormones , risk assessments do not 
need to be based on "monolithic" evidence. 
                                                      
727 See Appellate Body Report on EC – Hormones , para.172.  Article 3.3 of the SPS Agreement  reads 
as follows: 
 
Members may introduce or maintain sanitary or phyt osanitary measures which result in a higher level 
of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international 
standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of 
sanitary or phytosanitary protection a Member determines to be  appropriate in accordan ce with the relevant 
provisions of paragraphs 1 through 8 of Article 5.   Notwithstanding the above, all measures which result in a 
level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations sha ll not be inconsistent with any other provision of this 
Agreement. (original footnote omitted)   
728 Appellate Body Report on EC – Hormones , para.102. Regarding the allocation of burden of proof in 
relation to the SPS Agreement  in this case, see paras. 7.377-7.383 above. 
729 The New Shorter Oxford English Dictionary  (1993), p. 1384. WT/DS321/R 
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  Conclusion  
7.626  We therefore conclude that if relevant evidence already exists, not any degree of insufficiency 
will satisfy the criterion under Article 5.7 that "rel evant scientific evidence is  insufficient". Having 
regard to our reasoning above, particularly with resp ect to scientific uncertain ty and the existence of 
international standards, we consider that, depending on the existing relevant ev idence, 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.730  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 pu t into question existing 
relevant evidence to the point that  this evidence is no longer suffici ent to support the conclusions of 
existing risks assessments.  We therefore need to determine whether this is the case here.  
(v) Alleged insufficiencies which should be addressed by the Panel 
7.627  The European Communities  argues that the most important gaps in the evidence are related 
to carcinogenicity, genotoxicity, dose-response and la ck of safe thresholds, endogenous production by 
pre-pubertal children, lack of reliable bioavailability data, possibilities of abuse and lack of control.  
In addition, the European Comm unities maintains that since th e latest SCVPH assessment, new 
scientific developments furt her support SCVPH conclusions.731 
7.628  At this juncture, the Panel  deems it appropriate to recall th at parties have submitted a large 
amount of materials which was often very intricate and complex.  The Panel believes that, as part of 
its obligations to make an objective assessment of the matter before it, including an objective 
assessment of the facts pursuant to Article 11 of th e DSU, it had to devise an approach which would 
allow it to address the issues on which insufficiencies were alleged in a clear and transparent manner. 
7.629  Whereas, 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 scientific evidence rega rding the five hormones is sufficient
732, it is also for the European 
Communities, in application of the principle that it is for each party to prove its allegations, to support 
its own allegations with a ppropriate evidence. This also has to be  considered in the light of the fact 
that, even though in this case the European Communiti es is the complainant, 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 presumption of consistency with 
the SPS Agreement  and GATT 1994 of measures wh ich conform to internati onal standards, guidelines 
and recommendations on the risk assessmen ts on which such measures are based.733   Since, in that 
context, the European Communities argues that the relevant scientific  evidence is insufficient, we 
                                                      
730 In its second written submission, at para. 149, the European Communities refers to the long latency 
period of cancer and the numerous confounding factors to  claim that it may not be in a position to demonstrate 
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. We understand this argument to mean that we should 
accept the "new scientific reality" referred to by the European Communities as c onstituting a situ ation where 
relevant scientific evidence has become insuffic ient within the meaning of Article 5.7 of the SPS Agreement .  
We do not consider that our test amounts to reque sting that the European Communities demonstrate the 
existence of a clear harm in order for Article 5.7 to apply to its measure.  Under the "critical mass" test, the new 
scientific information and evidence must be such that they  are at the origin of a chan ge in the understanding of a 
scientific issue.  
731 EC's second written submission, paras. 137-138. 
732 See Appellate Body Report in  Japan – Agricultural Products II , para.80;  Panel Report in Japan – 
Agricultural Products II, para. 8.13 ;  Panel Report in EC – Approval and Marketing of  Biotech Products , 
paras. 7.2969-7.2979. 
733 See paras. 7.621-7.625.  WT/DS321/R 
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  consider that it is for the European Communities to identify the issues for which such evidence is 
insufficient. 
7.630  Therefore, we do not consider that, as Pane l, we have any obligation to go beyond the 
insufficiencies identified by the European Communiti es. We recall that we are neither equipped, nor 
supposed to make a de novo  review of the scientific evidence regarding the hormones at issue.  Under 
the circumstances, we deem it appropriate to limit our review exclusively to the "insufficiencies" 
expressly identified by the European Commun ities in its submissions to the Panel. 
7.631  We note that, in its second written submission, the European Communities considers that the 
scientific evidence on which JECFA and Codex relied is insufficient with respect to the following 
issues: (a) carcinogenicity; (b) hormones daily produc tion rate, in particular in pre-pubertal children; 
(c) dose response and lack of a safe threshold; (d) bioavailability; and (e) misuse or abuse (misplaced 
implants, off-label use, black market drugs, etc.).734  
7.632  The European Communities also inserted in its re plies to the first series of questions of the 
Panel and in its second written submission extensiv e portions of the 1999 and 2002 Opinions.735   
7.633  In other words, the European  Communities made its own description of the issues with 
respect to which it believes that evidence is insu fficient and added quotations in support of its 
allegations.  These passages also  identify insufficiencies.  
7.634  A number of issues discussed by the Europ ean Communities as part of the arguments 
contained in its submissions seem to overlap with the issues identified in the portions of the Opinions 
quoted by the European Communities.  However, a number of specific issues identified in the 
quotations are simply not directly discussed  by the European Communities in its submissions.  
7.635  We believe that it is incumbent upon a party ma king a particular allegation to identify in its 
submissions the relevance  of the evidence on which it relies to support its arguments.736  We consider 
that, for some of the issues identified in the Opin ions, this was not the case.  The Opinions were 
obviously quoted by the European Communities as ev idence of the insufficiencies it has identified in 
its Opinions.  However, the European Communiti es, while stating that the Opinions identified 
relevant issues, basically left it to the Panel to find out on its own the relevance of certain issues 
identified in the quotations for the question whethe r relevant scientific evidence was insufficient or 
not.737 
7.636  The Panel is therefore of the view 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.  It will only address the issues identified in the 
Opinions to the extent they are sufficiently related to an issue discussed  by the European 
Communities.   
7.637  A second question relates to the fact that, even when a particular insufficiency was 
specifically discussed by the European  Communities, elements were not always available to address 
this insufficiency on a hormone-specific basis.  The arguments and generally the information 
presented to the Panel were not always specific en ough to permit this.  In spite of our repeated 
                                                      
734 We have already explained in para. 7.578 why we do not believe that abuse or misuse is an issue of 
insufficiency of relevant evidence.   
735 See EC's reply to questions 22 and 30 of the questions of the Panel after its first substantive 
meeting, Annex B-1, and part 2, Section II.B and S ection III.C of the EC's second written submission.  
736 See Appellate Body Report in Canada – Wheat Exports and Grain Imports , para. 191. 
737 See Appellate Body Report on US – Gambling , para. 140. WT/DS321/R 
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  requests, several questions were addressed by the par ties or the experts in general terms, rather than 
specifically for each of the five hormones, thus making an assessment of particular issues hormone-
by-hormone sometimes impossible. 
7.638  Under the circumstances, the Panel decided: 
(a) first, to address the insufficiencies as identified and discussed  by the European 
Communities in its arguments and only to the extent evidence had been submitted by 
the parties in relation to them.  This appro ach is, in our opinion, consistent with the 
requirement identified by the Appellate Body in its report on Japan – Agricultural 
Products II  that panels refrain from "making a case" for one party in the absence of a 
prima facie case by that party;738 
(b) second, to address some concerns aggregately fo r all of the five hormones at issue, to 
the extent that information was not submitted on an hormone-specific basis, or to the 
extent an issue was raised with respect to all hormones, but evidence submitted only 
for one or two of them; and 
(c) third, to address individually for each  hormone the issues for which specific 
information on that hormone was provided to the Panel.  
7.639  For these reasons, we have decided to address first, in a "common issues" section, the 
insufficiencies which were not addressed by the pa rties and the experts in a hormone-specific manner 
(i.e. those for which arguments or evidence were not  hormone-specific), or which were not addressed  
specifically enough to justify a separate analysis for each of the hormones concerned. At a second 
stage, we address for each hormone the alleged insu fficiencies which have been discussed in relation 
to that hormone and for which arguments and evidence were specifically provided. 
(vi) Issues common to all five hormones for which evidence was not provided on a hormone-
specific basis 
Introduction  
7.640  We note that, despite our insistence that in formation be provided for each of the five 
hormones at issue, arguments, information and opini ons have sometimes addressed all or part of the 
scientific evidence on these hormones together. As a r esult, in this section, we will address the issues 
that were specifically discussed by the European Communities in these proceedings in relation to all 
five hormones in general regarding their use as growth  promoters in cattle. More particularly, we will 
address: 
(a) the effects of hormones on certain categories of population, such as pre-pubertal 
children; 
(b) dose response; 
(c) bioavailability; 
(d) the EC claim that the long latency period of cancer makes it more difficult to 
demonstrate insufficiency of the relevant  evidence regarding the carcinogenicity of 
the hormones at issue; 
                                                      
738 See Appellate Body Report on Japan – Agricultural Products II , para. 129.  WT/DS321/R 
 Page 261 
 
 
  (e) the impact of the five hormones at issue on the immune system; and 
(f) the impact of the five hormones at issue on development and reproduction. 
Effects of hormones on certain categories of population  
7.641  Regarding the effect of the hormones at issu e on certain categories of populations, we note 
that the European Communities refers to the conclu sions contained in the Opinions.  We recall that 
the 1999 Opinion mentions that prepubertal and postmenopausal women and prepubertal and adult 
men have the lowest levels of endogenous oestrogens and progest erone and thus would represent the 
individuals most likely to be at increased risk for the adverse health effects that might be associated 
with exposure to exogenous sour ces of oestrogens.  Likewise, the 1999 Opinion provides that all 
women and prepubertal men represent the individuals at greatest risk for adve rse health effects that 
might be associated with exposure to  exogenous sources of testosterone. 
7.642  The 1999 Opinion specifies that the hormone le vels on which it relies were determined by 
radio-immunoassays (RIA) and that the use of th ese 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 identifie d values of oestradiol considerably lower than the range of 
oestradiol levels found through RIAs for prepubertal  children.  The 1999 Opinion concludes that "[a] 
corollary is that perhaps the hormones residues in  beef, which are also low and which have been 
determined by RIA are equally variable a nd over representative of the actual hormones 
concentration."  The 1999 Opinion concludes that this is a critical area requiring additional study.739 
7.643  We recall our test regarding insufficiency of rele vant evidence in this case,  i.e. that there must 
be a critical mass of new eviden ce and/or information that calls into question the fundamental 
precepts of knowledge and evidence so as to make relevant, previously sufficient, evidence now 
insufficient.  In that context, we believe that the question before us is whether the more sensitive 
detection methods which identified lower hormonal levels in pre-pubertal 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. 
7.644  Dr. Sippell specified that: 
"There is no doubt that the development of an ultrasensitive recombinant cell 
bioassay (RCBA) of E 2 by Karen Klein, Gordon Cutler and co-workers at the N.I.H.  
in Bethesda, USA (Klein et al 1994) represented a quantum leap in E 2 assay 
methodology.  It opened a new door on our understanding of basic physiological 
phenomena, e.g.  why normal puberty starts so much earlier in girls than in boys or why bone maturation in children differs so much between the sexes.  The validity of 
the N.I.H.-RCBA has now been confirmed by another RCBA of E
2 which was 
developed by Charles Sultan's group at the Univ ersity of Montpellier, France (Paris et 
al 2002).  Unfortunately, the complexity of the RCBA so far prevents its wider use 
                                                      
739 The 2002 Opinion refers to a new method to det ect trace amounts of hormones in meats and to three 
complementary bioassays involving different recombinant-DNA technology for screening and determination of 
oestrogenic potency of substances used as growth promoters (2002 Opinion, p. 9).  The Panel nonetheless understands that these method and bioassays address a different issue than the identification of endogenous 
levels of hormones in humans. WT/DS321/R 
Page 262 
 
 
  for routine measurements in small serum samples from infants and prepubertal 
children."740 
7.645  We also note Dr. Sippell's statement that "[t]he  risk to children arising from hormones which 
are naturally present in meat as compared to that from residues of hormonal growth promoters has, to 
my knowledge, been estimated for E 2  [i.e. oestradiol-17 β] only and only in beef (Daxenberger et al. 
2001)."741 
7.646  We recall the statement of the 2000 Opinion referring to novel techniques in chemical 
analysis742 but mentioned that "additional time will be re quired to validate and apply this methodology 
in a reliable, accepted fashion before a re-e valuation of this issue can be conducted."743  This opinion 
is confirmed by Dr. Boobis.744  Dr. Boobis expressed additional co ncerns about the validity of the 
Klein et al. (1994) study: 
"There is certainly some evidence that e ndogenous levels of hormones in children are 
lower than previously thought.  However, th e suggestion that this is by orders of 
magnitude is not substa ntiated by the data.  One group has reported very low levels of 
oestradiol in male children, 0.08 pg/ml (Klein et al, 1994),  but in a later study (Klein 
et al, 1998),  the same group reported mean levels somewhat higher, at 0.27 pg/ml.  
The reliability of the Klein et al assay h as yet to be determined.  The assay is 
particularly sensitive to oestradiol, but th ere is no obvious explanation for this, as it 
relies upon affinity for the oestrogen receptor.   Diethylstilbestrol is a potent oestrogen 
yet is much less sensitive than oestradiol in the assay.  Klein et al (1994)  have 
reported that there are unidentified factors in plasma and in blood collection tubes that can interfere in the assay.  In c ontrast, using a similar yeast-based assay, 
Coldham et al (1997)  found that oestradiol and DES had similar potency, and others 
have found that, if anything, DES is more  potent than oestradiol in such assays 
(Folmer et al, 2002).  At the very least, this shows that results with the yeast reporter 
assay are not consistent, and use of such data in risk assessment requires that the 
assay be adequately validated.
745 
However, there are studies from two other gr oups using more specific methods than 
the original radioimmunoassay, reporting that le vels were somewhat higher than this.  
Ikegami et al (2001)  used a very sensitive, 2-stage immunoassay technique.  This was 
                                                      
740 Reply of Dr. Sippell to question 40 of the Panel, Annex D, para. 328. 
741 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 335. 
742 Results of "hormone" residue analyses of bov ine meat and liver imported into the EU and 
originating from the USA "Hormone  Free Cattle Program" analysis – First Interim Report, May 1999 – 
R.W. Stephany and F. André (rapporteurs). 
743 2000 Opinion, p. 3. 
744 Transcript of the Panel meeting with the experts, Annex G, para. 572. 
745 Dr. Boobis' reply to question 40 of the Panel, Annex D, para. 324.  Dr. Boobis cites to: 
 
Coldham NG, Dave M, Sivapathasundaram S, McDonnell DP, Connor C and Sauer MJ (1997).  Evaluation of a recombinant yeast cell estrogen screening assay.  Envi ron Health Perspect, 
105:734-742 
Folmar LC, Hemmer MJ, Denslow ND, Kroll K, Chen J, Cheek A, Richman H, Meredith H and Grau 
EG (2002).  A comparison of the estrogenic potencie s of estradiol, ethynylestradiol, diethylstilbestrol, 
nonylphenol and methoxychlor in vivo and in vitro.  Aquat Toxicol, 60:101-110 
Klein KO, Baron J, Colli MJ, McDonnell DP and Cutle r GB Jr (1994).  Estrogen levels in childhood 
determined by an ultrasensitive recombinant cell bioassay.  J Clin Invest, 94:2475-2480   
Klein KO, Baron J, Barnes  KM, Pescovitz OH and Cutler GB Jr (1998).  Use of an ultrasensitive 
recombinant cell bioassay to determine estrogen levels in girls with precocious puberty treated with a 
luteinizing hormone-releasing hormone agonist.  J Clin Endocrinol Metab, 83:2387-2389  WT/DS321/R 
 Page 263 
 
 
  shown to be specific and sensitive.  In th is assay, mean levels of oestradiol in 
prepubertal males were 1.85 pg/ml (6.8 pmol/ml).  Paris et al (2002)  used a 
recombinant oestrogen receptor assay in a ma mmalian cell line, a similar principle to 
the assay of Klein et al.  In this study, estrogenic levels in prepubertal males were 
found to be 1.44 pg/ml.  There are many issues affecting such measurements.  These 
include the presence of binding proteins, rela tive specificity and sensitivity.  None of 
the assays is entirely specific for oestradi ol.  Both the oestrogen receptor and the 
antibodies used could cross-react with st ructurally relayed compounds.  Depending 
on how the assay is performed, protein bind ing could reduce the concentration of 
hormone detectable in the assay by sequestering hormone from the assay target.  
However, it should be noted that whilst binding to protein in plasma my reduce clearance it will also reduce the biologically active dose.  In general, it is the free 
concentration that determines biological activity (Teeguarden and Barton, 2004) .  
Hence, if SHBG is elevated in children th is would tend to reduce the effect of an 
equivalent total plasma concentrati on by reducing the free concentration. 
The advantage of the recombinant assays is that they measure biologically active 
material, whereas the immunoassays may include cross-reacting less or inactive metabolites.  Whilst the recombinant assays may include hormonally active material 
other than the specific analyte, this does pr ovide an indication of to what the body is 
exposed in vivo.  Hence, on balance, the data of Paris et al (2002)  may be the most 
meaningful to date.  This presumably reflects circulating total active oestrogenic 
material, but not that bound to proteins."
746 
7.647  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 resp ect to the five other 
hormones at issue, not oestradiol.  We note furt hermore that the 2002 Opinion concludes that these 
more sensitive detection methods have not yet been validated.747 
7.648  On the basis of the above, 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 est ablished 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. 
                                                      
746 Reply of Dr. Boobis to question 40 of the Panel, Annex D, paras. 325-326. Dr. Boobis cites to:  
 
Ikegami S, Moriwake T, Tanaka H, Inoue M, Kubo T, Suzuki S, Kanzakili S and Seino Y (2001).  An 
ultrasensitive assay revealed age-related changes in serum oestradiol at low concentrations in both 
sexes from infancy to puberty.  Clin Endocrinol (Oxf), 55:789-795 
Paris F, Servant N, Terouanne B, Balaguer P, Nico las JC and Sultan C (2002).  A new recombinant cell 
bioassay for ultrasensitive determination of serum estrogenic bioactivity in children.  J Clin Endocrinol 
Metab, 87:791-797 
Teeguarden JG and Barton HA (2004).  Computational modeling of serum-binding proteins and 
clearance in extrapolations across  life stages and species for endocr ine active compounds.  Risk Anal, 
24:751-770 
 
747 2002 Opinion, Section 4.1.1, p. 9. WT/DS321/R 
Page 264 
 
 
  Dose response  
7.649  The European Communities, in its reply to a question of the Panel748, quotes an extract of the 
1999 Opinion.749  Whereas this quotation relates to trenbolone  acetate, we decided to address it in this 
general section to the extent that the impossibility  to perform a dose-response assessment is referred 
to by the European Comm unities with respect to the five hormones at issue.750  
7.650  The European Communities also questions JECFA's findings on dose response as follows: 
"The above findings establish that the le vels of endogenous production of these 
hormones by pre-pubertal children  is much lower than previously thought and this 
finding, which is subsequent to the 1999 JECFA report, casts serious doubts about the 
validity of JECFA’s findings on the dose-response relationship, because the data on 
endogenous production on which JECFA based its findings are also very old (since 
1974)."751 
7.651  The Panel can only conclude from the comme nts of the European Communities that it 
considers that a dose response would be required to  complete a risk assessment for the five hormones 
other than oestradiol-17 β, but that it disagrees with JECFA's findings on dose response.  The Panel 
notes that JECFA could identify a dose response for th e five hormones at issue.  Comparatively, the 
European Communities has not provided convincing elements to support its view that there is 
insufficient relevant evidence on dose response.  Th e EC position on dose response, at least for the 
natural hormones other than oestradiol,  seems to be based on the belief that levels of endogenous 
production of hormones are much lower than previously  thought.  The Panel notes in this regard that 
it has been demonstrated that the ultrasensitive assay relied upon by  the European Communities to 
conclude that endogenous production is lower than assumed by JECFA has not yet been validated and 
applies only to oestradiol. 
7.652  For these reasons, the Panel believes that it h as 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. 
                                                      
748 EC's replies to Panel questions after the first substantive meeting, question 22, Annex B-1. 
749 1999 Opinion, para. 4.4.8. 
750 See the following paragraphs of th e EC's second written submission: 
– para. 150, regarding the effect of progesterone on growth and reproduction: "No assessment of 
the dose response relationship has been presented yet." Also: "In conclusion, these data 
indicate that progesterone can cause immuno de pression; however, they are insufficient to 
make any realistic assessment of the dose response relationship." (Both from the 1999 
Opinion, pp. 51-55); 
– para. 153, regarding the effect of testosterone on growth and reproduction: "No assessment of 
the dose response relationship has been presented yet."  Also: "There are limited experimental 
data on the effects of testosterone on immuno response but none on the dose response 
aspects." (Both from the 1999 Opinion, p. 50); 
– para. 156, regarding the effects of trenbolone on growth and reproduction: "These data do not 
allow a realistic assessment of a dose response relationship." (1999 Opinion, p. 60); 
– para. 161, regarding melengestrol acetate: "These  data do not allow an estimate of the dose 
response relationship." (1999 Opinion, p. 68); 
– para. 158, on the effects of zeranol on growth and reproduction: "No estimate of the dose-
response relationship for these effects can be made."( 1999 Opinion, p. 65). 
751 EC's second written submission, para. 104.  WT/DS321/R 
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  Bioavailability  
7.653  The European Communities argues that another area where recent developments put in doubt 
the findings of the 1999 JECFA report concerns the bioavailability  of residues of the hormones 
concerned.  According to the European Communities, the 1999 and 2002 Opinions have found that data on which JECFA based its findings are incorrect or insufficient.
752 
7.654  The Panel notes that the studies referred to in th e 1999 and 2002 Opinions (one of them being 
study 3 of the 17 studies commissioned by the European Communities)753 relate to oestradiol-17 β, not 
to any of the specific hormones with respect to which the European Communities applies a 
provisional ban under Article 5.7 of the SPS Agreement .  Moreover, there is no indication that the 
conclusions can be applied to ot her hormones than oestrogens.  
7.655  The Panel recalls that the European Commun ities argued that "similar findings [had been] 
made for all of the other five hormones."754 However, the European Communities did not specify 
where such findings had been made.  The European  Communities also refers to study 10 of the 
17 studies, by Dr. Florence Le Gac, but does not clearly explain to what extent the results of this study 
establish or discuss the bioavailability of the five ot her hormones.  This allegation of the European 
Communities has to be considered in light of the statements of Dr. Boisseau and Dr. Boobis according 
to which the bioavailability of melengestrol, trenbolone and zeranol residues has not been 
determined.755  
7.656  The Panel considers that bioavailabity would be an issue if the new ev idence suggested that 
bioavailability in the case of ingestion of meat tr eated for growth promotion purposes is higher than 
previously thought.  However, it appears that , in the absence of data, JECFA assumed 100% 
bioavailability. 
7.657  In this respect, Dr. Boisseau said: 
"The bioavailability of melengestrol, tre nbolone and zeranol residues have not been 
determined.  Therefore all their residues have been considered as being totally 
bioavailable."756 
7.658  Dr. Boobis stated, with respect to natural hormones,  that "change in bioavailability is likely to 
be a consequence of changes in the enzymes of metabolism in the liver and/or small intestine."757 
7.659  Dr. Boobis also confirms for the non-natural hormones:  
"However, it should be noted that in the risk assessment of these hormones by 
JECFA, the risk characterization involved comparison of the theoretical maximum 
daily intake with the ADI.  No correction was made for bioavailability.  Hence, the situation is likely to be similar to that for the natural hormones, in that changes in 
bioavailability from the normal value w ould change the margin of safety."
758 
                                                      
752 EC's second written submission, para. 105. 
753 2002 Opinion p. 12, point 4.1.5, Exhibit CDA-7;  Study 3: "Estrogenic activity of oestradiol and its 
metabolites in the ER- CALUX assay with human T47D br east cells", APMIS 109: 101-7, 2001. Exhibit EC-9. 
754 EC's reply to question 28 of the questions of the Panel after the first substantive meeting, 
Annex B-1, para. 158. 
755 Dr. Boisseau, Annex D, para. 347. 
756 Annex D, para. 347. 
757 Annex D, para. 350. 
758 Annex D, para. 351. WT/DS321/R 
Page 266 
 
 
  7.660  These statements were not contradicted by Dr. Guttenplan, the third and last expert who 
replied to question 43 of the Panel, a nd who limited his remarks to oestrogens.759 
7.661  We therefore conclude that it has not been established that any new evidence on 
bioavailability has been developed regarding specifi cally the five hormones at issue, which would 
affect the current knowledge on the subject. More pa rticularly, no new evidence has been submitted 
regarding the three non-natural hormones which would make it impossible to perform a risk 
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement . 
Long latency period of cancer and confounding factors  
7.662  Regarding the long latency of can cer, in its second written submission760, the European 
Communities claims that it may not be in a position to demonstrate the existence of a clear harm in 
case of cancer because of the long latency period a nd the numerous confounding factors that play a 
role in the development of cancer. 
7.663  We first note the importance of latency period in the assessment of cancer, as confirmed by 
Dr. Cogliano, Dr. Guttenplan and Dr. Boobis: 
7.664  Dr. Cogliano stated that:  
"It is definitely necessary to take into acc ount the latency period of cancer in the 
conduct of a risk assessment.  In this  regard, the guidelines for developing IARC 
Monographs  state, 'Experience with human cance r indicates that the period from first 
exposure to the development of clinical cancer is sometimes longer than 20 years; 
latent periods substantially shorter than 30 years cannot provide evidence for lack of 
carcinogenicity.' [International Agency for Research on Cancer, Preamble to the IARC Monographs , http://monographs.iarc.fr]"
761 
7.665  Dr. Guttenplan confirmed that: 
"When epidemiological data is used in performing a risk assessment, the latency 
period is extremely important. Usually a latent  period of 20 years is taken for cancer, 
but this varies with the carcinogen. It is  indeed necessary to determine incidence or 
prevalence at different times after the onset of exposure. Attempting to perform a risk 
assessment based on epidemiological data obtained too soon after the onset of 
exposure can seriously underestimate risk."762 
7.666  Dr. Boobis stated that: 
"The latency period is an important cons ideration in risk assessment, both in the 
design and in the interpretation of studies.  Thus, the duration of exposure, either of 
experimental animals or in epidemiology  studies, should be sufficiently long to 
permit assessment of effects with a long latency period.  Most forms of cancer come 
into this category."763 
                                                      
759 Annex D, para. 357. 
760 EC's second written submission, para. 143. 
761 Reply of Dr. Cogliano to question 23 of the Panel, Annex D, para. 213. 
762 Reply of Dr. Guttenplan to question 23 of the Panel, Annex D, para. 214.  Dr. Guttenplan cited to 
Lagiou P. Trichopoulou A. Tric hopoulos D. Nutritional epidemiology of can cer: accomplishments and 
prospects. [Lectures] Proceedings of the Nutrition Society. 61(2):217-22, 2002. 
763 Reply of Dr. Boobis to question 23 of the Panel, Annex D, para. 210.  WT/DS321/R 
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  7.667  Dr. Boobis added that: 
"The observational studies of humans (e.g. on HRT or oral contraceptives) and the 
experimental studies in animals covered a su fficiently long period to encompass the 
latency period for any carcinogenic effects of the hormones (see IARC, 1999) . 
7.668  Dr. Boisseau  highlighted the practical difficu lties resulting from confounding factors, arguing 
that: 
"[He did] not think possible/useful to take into account the "long latency period" of 
cancer in order to assess properly and specifi cally the carcinogenic effects of residues 
of natural hormones only resulting from the treatment of food producing animals by 
growth promoting hormones. ... epidemiological  studies carried out in humans during 
[periods] long enough in order to take into  account this "long latency period" will not 
be able to discriminate, in the case of a possible but limited increase of tumours, 
between the responsibilities of (1) hormone residues resulting from the treatment of 
food producing animals by growth promoting hormones, (2)  hormone residues 
resulting from the endogenous production of these animals, (3) other components of 
the diet including other food additives and cont aminants. That is the reason for which, 
... the epidemiological studies in humans al ready carried out in this domain have 
failed to identify any relation between the occurrence of hormonally dependent 
tumours and the consumption of meat containing hormonally active residues resulting 
from the treatment of cattle with growth promoters."764 
7.669  Dr. Boobis added that: 
"The long term studies of the hormones undertaken in experimental animals and in 
humans, involved much higher doses than w ould be encountered on consumption of 
meat from animals treated with growth promoting hormones.  The maximum risk 
from such low levels of exposure, even assuming a linear dose-response relationship 
for cancer, would be such that it woul d be necessary to study extremely large 
populations to detect any increase in cancer incidence, particularly as the most likely 
cancers are quite common.  This is because the lower the risk the greater the number 
of subjects that are required to detect it, a function of the power of the study which 
takes account the magnitude of the risk and the difference from the background rate (Hunter, 1997) .  Hence, in the risk assessment of the hormones used as growth 
promoters, it is questionable whether an incr ease in risk, even if it existed, could be 
detected in exposed populations.  However, it is still necessary to protect against such 
a risk.  The risk assessment of the horm ones conducted by JECFA suggested that 
there would be no risk at exposure levels up to the respective ADI.  Even if duration 
of exposure were for a sufficiently long period (usually 20-25 years for solid tissue tumours), any increase in risk would probabl y not be detectable.  Hence, a negative 
result from such an observational st udy would not resolve the issue. 
A second issue with respect to the latency is  the significance it has for interpretation 
of the exposure pattern. Where there is a long latency, and regular exposure is 
necessary before a carcinogenic response is ma nifest, as appears to be the case for the 
hormones in question (Coombs et al, 2005) , occasional exposures above the ADI will 
                                                     
 
764 Reply of Dr. Boisseau to question 23 of the Panel, Annex D, para. 209. WT/DS321/R 
Page 268 
 
 
  not pose any additional risk (Larsen and Richold, 1999) .  Hence, latency is of value 
in assessing the risks from different exposure scenarios."765 
7.670  The European Communities acknow ledges that epidemiological studies will not be able to 
discriminate (or separate out) the true origin of cancer  because of so many confounding factors. In this 
respect, we note that Dr. Cogliano specified that it was generally possible to identify confounding 
factors in epidemiological studies. It was often di fficult, however, to determine whether the observed 
tumours can be attributed to the agent under study or to a confounding factor.  Dr. Cogliano adds that 
"[w]hen a causal interpretation is credible but  confounding factors cannot be ruled out, IARC 
considers this to provide limited evidence of carcinogenicity ."766 
7.671  The European Communities insists, however, that this undermines the opinion of the 
respondent that the hormones at issue have been in use for a sufficiently long time to rule out their 
carcinogenic effect on humans.  The European Co mmunities points at IARC studies showing that the 
frequency of breast cancer in countries where use of  hormones for growth promotion is allowed is 
higher compared with countries where the hormones have not been used.767  
7.672  Three experts addressed this issue. Dr. Cogliano mentioned that: 
"The difference between the US and the EC in rates of breast cancer and prostate 
cancer almost certainly has multiple causes.  It  is possible that differences in exposure 
to exogenous hormones can be one cause, but the data are not sufficiently specific to 
establish a link between these observations."768 
7.673  Dr. Guttenplan confirmed that: 
"The epidemiological studies do not identify a relationship between cancer and 
residues of hormonal growth promoters.  The references to the higher rates of breast 
and prostate cancer observed in the Unite d States as compared to the European 
Communities are not very convincing as there is considerable variation in rates in 
different geographical locations.  Also, the differences in rates of breast and prostate 
cancer observed in the United States as co mpared to the European Communities are 
relatively small.  There is no way to defin itely establish a link between these statistics 
and the consumption of meat from animals treated with the hormones at issue as there 
are many possible confounders, and the differences in cancer rates are small.  
                                                      
765 Dr. Boobis cites to the following studies: 
 Coombs NJ, Taylor R, Wilcken N, Fiorica J and Boyages J (2005). Hormone replacement therapy and 
breast cancer risk in Califor nia. Breast J, 11:410-415  
Hunter DJ (1997). Methodological issues in the us e of biological markers in  cancer epidemiology: 
cohort studies. IARC Sci Publ, 142:39-46 
IARC (1999). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol 72. 
Hormonal Contraception and Post-menopausa l Hormonal Therapy, IARC, Lyon, France 
Larsen JC and Richold M (199). Report of workshop on the significance of excursions of intake above 
the ADI. Regul Toxicol Pharmacol, 30:S2-12.  
See Reply of Dr. Boobis to question 23 of the Panel, Annex D, para.212. 
766 Reply of Dr. Cogliano to question 24 of the Panel, Annex D, para.220.  See also Dr. Guttenplan, 
Annex D, para.221. 
767 EC's comments on experts' replies to questions 23 and 24 of the Panel, Annex F-1, pp. 19-20. 
768 Reply of Dr. Cogliano to question 26 of the Panel, Annex D, para. 241.  WT/DS321/R 
 Page 269 
 
 
  However, the results are at least consistent with a possible effect of hormones on 
breast and prostate cancer."769 
7.674  In this regard, Dr. Boobis added the following: 
"There are an appreciable number of studies showing an association between the risk 
of certain cancer types, including breast and prostate and the consumption of meat 
(Colli and Colli, 2006; Norat et al, 2005; see also SCVPH Opinion, 1999) .  For 
breast, the incidence is similar in develope d countries such as Western Europe, North 
America and Australasia.  The correlation is strongest with meat consumption and 
shows little relationship with whether the meat  is from animals treated with growth 
promoting hormones or not.  For example rates in Iceland (87.2 per 100,000), where 
such hormones are not used, are not dissimilar to those in the USA (101.1 per 
100,000), where they are used.  Prostate cancer rates are 124.8/100,000 in the USA and 90.9 per 100,000 in Sweden (IARC, 2002) .  For comparison, average daily 
consumption of meat (as protein) in 2000 was as follows: USA 40.2 g/day; Iceland 
29.5 g/day; Sweden 24.8 g/day (FAO, 2003) .  Hence, there is a much better 
association with meat consumption and risk of breast or prostate cancer than there is 
with the use of growth promoting hormones to treat cattle.  It is also important not to infer too much from geographical differences in  cancer incidence rates with respect to 
causation.  This is because of what is know n as the ecological fallacy.  This has been 
defined as the inference that a correla tion between variables derived from data 
grouped in social or other aggregates ( ecological units) will hold between persons 
(individual units)  (Society for Risk Assessment, 2004).  The difficulty is that many 
factors will vary between populations, including ethnicity, genetics, health and socioeconomic status, diet, lifestyle and environment.  Without considering the 
possibility of confounding, such ecological da ta is really only of value in generating 
hypotheses (Morgenstern, 1995) .  These would need to be evaluated in more 
structured investigations, with bette r control of confounding variables."
770 
7.675  We also note Dr. Boobis statement at the meeting of the Panel with the experts: 
"The paradigm we have, and there is some ev idence to justify the case that this is a 
reasonable assumption, is that the eff ects observed scale to the lifetime of the 
organism, and so that is one of the reasons we use shorter-lived organisms in our 
toxicological testing.  We use rats and mice which live for a couple of years; otherwise we would have to test for a li fetime in a longer-lived species which might 
be 40 or 50 years.  So we are working on th e principle that effect s that are not evident 
within the lifetime of a rodent would not be  evident, all other things being equal, 
within the lifetime of a human being.  And there is actually very good evidence that 
that is the case.  For a number of carci nogens that IARC have  evaluated it takes 
approximately a quarter of a lifetime after an initial exposure for those tumours to become apparent, and that is true in rodents, it's true in dogs and it's true in humans.  
So I think that the paradigm is reasonable that if there is going to be an effect 
                                                     
 
769 Reply of Dr. Guttenplan to question 26 of the Panel, Annex D, para. 242. 
770 Reply of Dr. Boobis to question 26 of the Panel, Annex D, para. 239.  Dr. Boobis cited to the 
following: 
 
Morgenstern H (1995).  Ecologic studies in epid emiology: concepts, principles, and methods.  
Annu Rev Public Health, 16:61-81 
Society for Risk Assessmen t (2004).  Glossary of Risk Analysis Terms. 
(http://www.sra.org/resources_glossary.php) WT/DS321/R 
Page 270 
 
 
  manifest over a lifetime, it will be revealed in those experimental systems and 
therefore be predictive of lifetime effects in humans by and large."771  
7.676  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 quite difficult. On the other hand, the Panel notes that it is possible to 
assess long term effects through long term studies of e xperimental animals, even if they involve much 
higher doses than would be encountered in consump tion of meat from animals treated with growth 
promoting hormones.  It has also been possible to take into account the risk attached to latency 
through the setting of ADI.  The European Communities has not identified any evidence 
quantitatively and qualitatively sufficient to call into  question the fundamental precepts of existing 
knowledge and evidence and the approach followed so far in order to integrate the long latency of 
cancer in risk assessment. 
7.677  Having regard to the opinions of the experts,  the Panel concludes that it has not been 
established that the difficulties attached to the lo ng latency of cancer make it impossible to perform a 
risk assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement .  More 
particularly, the European Communities did not point  at a "critical mass" of new evidence and/or 
information that would call into question the fu ndamental precepts of previous knowledge and 
evidence in relation to the long latency period of  cancer and the existence of confounding factors. 
Effect of hormones on the immune system  
7.678  The 1999 Opinion considers, for each of the fi ve hormones for which a provisional ban is 
applied, that there is insufficient eviden ce as to their effect on the immune system.772 The Panel notes 
that no arguments have been raised specifically in relation to the effects of hormones on the immune system with respect to each of the five hormones at  issue. The Panel noted, however, the contention of 
the European Communities that new important gaps , insufficiencies and contradictions had been 
identified in the scientific information and knowle dge now available as a result of the 17 studies 
commissioned by the European Co mmunities.  The Panel considered  that an appropriate way to 
address this question with respect, inter alia , to the effect of hormones on the immune system was to 
seek the views of the scientific experts on the f actual question whether the new scientific studies 
initiated since 1997 and relied upon  by the European Communities id entify any adverse effects on the 
immune system from the consumption of meat fr om cattle treated with the growth promoting 
hormones at issue.
773  
7.679  Three experts expressed their views on the matter.  Dr. Boobis argued that:  
"The evidence on immune effects of hormon es such as oestradiol referred to by the 
EC does not identify any adverse effects on the immune system from consumption of 
meat from treated cattle.  In general, clear evidence for immune effects were observed 
only at high doses.  There is no evidence that doses such as those resulting from 
consumption of meat from treated animals has any effect on the immune system 
(JECFA , 2000b; CVMP, 1999).  It should also be noted, that in the case of immune 
effects, exposure relative to endogenous leve ls is a critical issue.  Given the large 
margin of exposure on anticipated intake fro m residues in meat fro m treated animals, 
                                                      
771 Annex G, para. 1031. 
772 There does not seem to be any additional development on this matter in the 2000 and 2002 
Opinions. 
773 Question 59 of the Panel to the experts.  WT/DS321/R 
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  no effect on the immune system is anticip ated, as immune modulation is dependent 
on dose and there are thresholds for such effects."774 
7.680  Dr. Guttenplan noted that: 
"The relationship between estrogen and autoimmune diseases has received 
considerable attention (Opinion SCVPH, April 30, 1999, section 2.4).  There is 
evidence that estrogens can be involved in L upus, rheumatoid arthritis, thyroiditis.  In 
addition the development of allergies is t hought to be at least partially related to 
estrogens.  The studies in experimental an imals also did not identify any immune-
related effects, although it is not certain th e types of possible effects in humans would 
be detected in experimental animals.  No  definitive studies have related intake of 
meat from hormone-treated animals to the above disorders."775 
7.681  We note that the Panel question related to a ll hormones and the experts gave details in 
relation to oestrogens in general.  We also note that the European Communitie s, in its comments on 
the experts replies, referred to effects identified by Dr. Guttenplan in relation to oestrogens.  The 
European Communities concludes that it has offered serious evidence and pointed to a number of gaps 
and uncertainties in the knowledge.  The European  Communities considers that it is for the United 
States, Canada and JECFA to "ensure the Panel that  adverse immune effects are not possible to occur 
from residues in meat treated with these hormones for animal growth promotion".776 
7.682  First, the Panel doubts that, in this particular case,  the standard of proof is that Canada should 
prove to the satisfaction of the Panel that "adverse immune effects are not possible to occur from 
residues in meat treated with th ese hormones for animal growth pr omotion" purposes.  As already 
specified, in this case Canada has to prove its a llegation that relevant sci entific evidence is not 
insufficient to perform an adequate risk assessm ent under Article 5.1 and Annex A(4) of the 
SPS Agreement . 
7.683  Second, with regard to the evidence and ga ps allegedly identified by the European 
Communities, the Panel notes that the statemen t of Dr. Guttenplan on which the European 
Communities relies relates exclusively to oestrogens.  The Panel notes in this respect that the other 
experts' replies to question 59 of th e Panel relate to oestradiol or o estrogens.  None of those replies 
related to any of the five hormones at issue.  The Panel notes that the 1999 Opinion itself does not provide evidence of impact on the immune system for testosterone.
777 For progesterone, the data were 
deemed to indicate that progesterone can cause imm uno depression.  However they were described as 
insufficient to make a realistic assessment of the dose response relationship.778 On trenbolone, the 
information was deemed insufficient to assess the possible impact of low levels of trenbolone in meat 
and meat products on consumers.779 For zeranol, the 1999 Opinion states that no relevant data on the 
                                                      
774 Reply of Dr. Boobis to question 59 of the Panel, Annex D, para. 445.  Dr. Boobis cited to: 
 
Barton HA and Clewell HJ 3rd (2000).  Evaluating non cancer effects of trichl oroethylene: dosimetry, 
mode of action, and risk assessment.  Environ Health Perspect, 108 (Suppl 2):323-334 
Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B, Schlatter J, van 
Schothorst F, Vos JG and Wurtzen G; European bran ch of the International Life Sciences Institute 
(2004).  Structure-based thresholds of toxicological concern (TTC): guidance for application to 
substances present at low levels in the diet.  Food Chem Toxicol, 42:65-83 
775 Reply of Dr. Guttenplan to question 59 of the Panel, Annex D, para. 447. 
776 EC's comments to experts' replies to Panel questions, Annex F-1, pp. 37-38. 
777 1999 Opinion, p. 51. 
778 1999 Opinion, p. 55. 
779 1999 Opinion, p. 60. WT/DS321/R 
Page 272 
 
 
  effect of zeranol on the immune system were found.780 Finally, for MGA, the 1999 Opinion concluded 
that the information was insufficient to make  a scientific judgement on whether MGA may cause 
effects on the immune system at a level which co uld occur in meat treated with MGA as a growth 
promoters.  The 2000 and 2002 Opinions do not seem to contradict these findings. 
7.684  The Panel also notes that the three experts w ho replied to question 59 addressed the potential 
effects of hormones on the immune system through a dose-response approach.781  The Panel has 
received no evidence suggesting that a dose response would not apply to the effect of the five 
hormones on the immune system as a result of the co nsumption of meat treated for growth promotion 
purposes. 
7.685  We therefore conclude that it is not established that there exists a critical mass of new 
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge 
and evidence so as to make relevant, previously  sufficient, evidence on hormones effects on the 
immune system now insufficient. 
Effect of hormones on growth and reproduction  
7.686  The Panel notes that no arguments have been ra ised specifically in relation to growth and 
reproduction with respect to each of the five hormon es at issue, except for the EC reference to the 
1999 Opinion. The Panel notes, however, the cont ention of the European Communities that new 
important gaps, insufficiencies and contradictions ha d been identified in the scientific information and 
knowledge now available as a result of the 17 studi es commissioned by the Eu ropean Communities.  
The Panel considers that an appropriate way to address this question with respect, inter alia , to the 
effect of hormones on growth and reproduction was to  seek the views of the scientific experts on the 
factual question whether the new scientific st udies initiated since 1997 and relied upon by the 
European Communities actually support its contention.782 
7.687  Three experts commented on our question, Dr. Boisseau, Dr. Boobis and Dr. Guttenplan. 
Only Dr. Boobis and Dr. Guttenplan discussed matte rs related to growth and reproduction.  
Dr. Guttenplan originally identified a number of gaps  that could relate to growth and reproduction.783  
However, Dr. Guttenplan subsequently stated that  "on subsequent reading, [he] could not find 
anything to indicate adverse effect", and he considered that it was possible to undertake a risk 
assessment.784 He added that "the ability [to make a ri sk assessment] varies between compounds, but 
that does not mean you can't make a risk assessment , it just means the accuracy of the risk assessment 
is different."785  
7.688  Dr. Boobis considered in general that: 
"[T]here is little information in the scien tific studies initiated by the EC since 1997 
that support the contention that they have identified important new gaps, 
insufficiencies and contradictions in the scientific information and knowledge on the 
hormones, and that additional studies are necessary before the risks to health of 
consumption of meat from treated animals can be assessed.  Whilst additional information has been obtained on a number of  aspects of the hormones in question, 
this was often not definitive, sometimes it was not relevant, in some instances it 
                                                     
 
780 1999 Opinion, p. 66. 
781 See also reply of Dr. Boissau to question 59 of the Panel, Annex D, para. 443. 
782 See question 62 of the Panel to the scientific experts, Annex D. 
783 Reply of Dr. Guttenplan to Question 62 of the Panel, Annex D, paras. 497-499. 
784 Transcript of the Panel meeting with the experts, Annex G, para. 981. 
785 Transcript of the Panel meeting with the experts, Annex G, para. 983.  WT/DS321/R 
 Page 273 
 
 
  confirmed or expanded on previous k nowledge.  The evidence obtained did not 
indicate any additional concern regarding the risk from exposure to residues of the 
hormones in meat from cattle treated for growth promotion."786 
7.689  Dr. Boobis also discussed the recent data on en docrine and developmental effects of the 
hormones at issue.  Regarding the experimental studies  on the effect of in utero exposure of rabbits to 
the three exogenous hormones: melengestrol acetate,  trenbolone acetate and zeranol, also referred to 
in the 2002 Opinion (study 11), Dr. Boobis noted that, to date, only information on metabolism and disposition had been published (Lange et al, 2002) .
787  According to Dr. Boobis: 
"[the Lange et al. paper (2002)]788 demonstrates transplacental transfer of the three 
hormones.  This is not surprising given the physicochemical properties of the 
compounds (lipid solubility, non-polar, molecular size) (Syme et al, 2004) .789  In 
addition, endogenous hormones ar e known to cross the placenta.  It is notable that in 
the study of Lange et al, fetal concentra tions of the hormones and their metabolites 
were similar to or less than, sometim es much less than, t hose in corresponding 
maternal tissues, suggesting that there w as no net accumulation of the compounds in 
fetal tissues.  It is also noted that the nu mber of animals studied was very small, a 
point commented on by the authors themselves.   
The unpublished component of this study was an investigation of the potential health 
consequences of in utero exposure of ra bbits to the three hormones.  From the 
information provided, low dose exposure in utero caused modest changes in some 
parameters, but was not associated with wither cancer or adverse effects on 
reproductive capacity.  There were no changes in sperm number.  It is not clear whether the changes observed were consis tent and hence compound-related as a only 
a single dose was used for each compound.  No r is it apparent whether the magnitude 
of all of changes discussed reached statis tical significance (often the changes were 
described as slight and no measure of vari ance is provided).  The doses used in this 
study would have provided much higher leve ls of exposure than those predicted to 
arise from residues in meat.  In the case of trenbolone acetate and zeranol exposure was via the subcutaneous route, thus bypassing presystemic metabolism in the 
intestine and/or the liver.  In the case of MGA the oral dose was over 16,500 times 
the ADI.  Hence, even if the effects obser ved were of toxicological significance the 
ADI would provide a more than adequate margin of protection.   
Overall, this study cannot be said to confirm a risk to human health from 
consumption of meat from animals treated with these hormones."
790  
                                                      
786 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 495. 
787 Dr. Boobis noted that, given the time that had elapsed since this paper was published (submitted 
September 2001), it was somewhat surprising the data from the remainder of the study had not been published 
yet. 
788 Dr. Boobis cited to Lange IG, Daxenberger A, Me yer HH, Rajpert-De Meyts E, Skakkebaek NE and 
Veeramachaneni DN (2002).  Quantitative assessment of fo etal exposure to trenbolone acetate, zeranol and 
melengestrol acetate, following maternal dosing in rabbits.  Xenobiotica, 32:641-651   See  Reply of Dr. Boobis 
to question 63 of the Panel, Annex D, paras. 488-490. 
789 Dr. Boobis cites to Syme MR, Paxton JW and K eelan JA (2004).  Drug transfer and metabolism by 
the human placenta.  Clin Pharmacokinet, 43:487-514.  Ibid. 
790 Dr. Boobis also discussed the study called "Retrospective study on long-term effects in children of 
following suspected exposure to oestrogen-c ontaminated meat" (stu dy 12) and the study  "In utero  exposure and 
breast cancer: a study in opposite sexed twins" (Study 13) .  However these  studies seemed to relates primarily 
to oestradiol.  See Reply of Dr. Boobis to questions of the Panel, Annex D, paras. 493 and 491. WT/DS321/R 
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  7.690  While the European Communiti es commented negatively on other considerations by 
Dr. Boobis, it does not seem to make any specific comment on the remarks of Dr. Boobis on study 11. 
7.691  Dr. Sippell mentioned that "the synthetic andr ogen Trenbolone and the gestagen Melengestrol 
bind with high affinity to the human androgen and progesterone receptors, respectively (Bauer et al., 
2000).  Exposure during pregnancy might result in severe transplacental virilisation of a female fetus."
791 
7.692  We note that Dr. Sippell does not indicate at what do ses such an effect might occur.  It is also 
not clear whether the last sentence (about exposure during pregnancy) refers to one of the studies identified by the European Communities, or whether it is expressing Dr. Sippell's own opinion.  We note, however, that Dr. Boobis said: "There is no basis to think that the effect of hormone growth promoters would be different in any way whatso ever from hormones naturally present in meat, at 
equivalent internal exposure levels."
792   
7.693  In paragraph 804 of Annex G, Dr. Sippell also stat es that: "It is, of course, difficult to answer 
such a question as a clinician, but from the experien ce we have with the low levels, I mentioned this 
several times before, with the extremely low levels that have been measured by these new 
recombinant assays, it is conceivable really that this  extra burden of oestradiol poses a risk to very 
small children and particularly prepubertal boys, and th is is in line with the very very high sensitivity 
of prepubertal children to oestrogens induced for other purposes."793   
7.694  We consider that, in that paragraph, Dr. Sippell merely argues that it is conceivable that there 
is a risk, but he is not saying that there is evidence of such a risk.  Dr. Sippell also stated: "... I think 
that as much as children are concerned, we know r eally by no means enough and the data are really 
insufficient to tell or to be confident that this additional exposure from hormone-treated meat poses no 
risk."794 Dr. Sippell's statements focused on oestradiol. 
7.695  At the hearing, Dr. Guttenplan also mentioned:  "So the potential genotoxic damage that is 
done in an adult would overwhelm that that could be done in a child.  However, in boys the levels are 
even lower, and there I think we have to worry a bout developmental effects, and there has been less 
said on that – Dr. Sippell has been the major proponent of that – and I still think that these could be investigated epidemiologically or in some type of  study.  We might, as Dr. Boobis suggested, need a 
surrogate, perhaps saliva or urine, but I think it is perhaps the most important issue to address is the 
sensitivity of children.  I should also mention hor mone-sensitive cancers in  post-menopausal women, 
it could be another concern."
795 
7.696  These two statement express doubts but do not cons titute evidence of risks. The Panel notes 
that science does not stop studying a substance ju st because there is sufficient evidence to conduct a 
risk assessment, but continuously re-evaluates subs tances.  Nothing in th e above cited passages 
suggests that the existing evidence w as insufficient to complete a risk assessment.  In fact, the Panel 
notes that  the European Communities has once agai n pointed the Panel to evidence that deals only 
with oestradiol, a hormone for which it claims to have completed a risk assessment.  The European 
Communities has not explained how the interventions  from the experts support a conclusion that the 
scientific evidence was insufficient to conduct a ri sk assessment with respect to the other five 
hormones. 
                                                      
791 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 336. 
792 Reply of Dr. Boobis to question 41 of the Panel, Annex D, para. 333. 
793 Annex G, para. 804. 
794 Annex G, para. 1063. 
795 Annex G, para. 1061.  WT/DS321/R 
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  7.697  The European Communities does not provide a dditional evidence in its comments regarding 
other hormones than oestradiol.796 
7.698  Having regard to the opinions of the experts, the Panel is of the view that it has not been 
established that there is a critical mass of new eviden ce 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 relation to the growth and reproduction effects of the hormones 
at issue. 
(vii) Is relevant scientific evidence insuffic ient in the case of progesterone 
Summary of the main arguments of the parties797 
7.699  Canada  argues that, as early as 1981, JECFA evaluated the health effects of residue levels 
present in human food obtained from animals trea ted with the naturally occurring hormones, i.e. 
oestradiol-17 β, progesterone and testosterone. In the Re port of its twenty-fifth meeting, JECFA 
concluded that residues from the use of these hormones according to good veterinary practices are unlikely to pose a hazard to human health. In 1989, JECFA published the residue monographs for 
testosterone and progesterone from its thirty-second  meeting in June 1987. Each of these reports 
reviewed several relevant scientific studies on resi due levels of these hormones in meat derived from 
treated animals. 
7.700  Canada recalls that, in February 1999, JE CFA conducted its most recent comprehensive 
evaluation of these three naturally occurring hormon es. In the Report of its thirty-second meeting, 
JECFA recommended ADI levels for all three of th ese substances. JECFA's most recent residue and 
toxicological monographs for testosterone, progesterone and oestradiol-17 β, published in 2000, 
reference the large number of studies relied on by JECFA to recommend ADIs for these hormones.
798  
Canada also notes that hormones such as progester one and testosterone are endogenously produced 
chemicals and thus it is unlikely that their transformation products would be of concern.799 
7.701  Canada concludes that it is evident, based on the scientific data contained in these JECFA 
reports and the recommended ADIs for these substan ces, that JECFA does not consider that residues 
of these hormones have an adverse effect on human health, provided they are used in accordance with 
good veterinary practices. Canada concludes that , faced with this conclusion from JECFA, the 
European Communities  cannot substantiate its assertion that there is insufficient scientific 
information to perform an adequate risk assessment in respect of these five hormones.800 
7.702  The European Communities  argues that the body of ev idence has developed since the EC – 
Hormones  case and, while still not providing enough knowledge to carry out a complete and 
definitive risk assessment, supports the conclusion that precautionary measures are required in order 
to achieve its chosen level of protection. 
7.703  The European Communities, quoting the 1999 Opinion, identifies the following 
insufficiencies in the evidence:801 
                                                      
796 EC's comments on replies from experts, question 41, Annex F-1, p. 29. 
797 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
798 Canada's first written submission, paras. 116-124. 
799 Canada's second written submission, para. 134. 
800 Canada's first written submission, paras. 116-124. 
801 EC's second written submission, para. 150. WT/DS321/R 
Page 276 
 
 
  (a) little knowledge about the specific enzymes in cattle that metabolize progesterone; 
(b) considerable uncertainty associated with the validity of daily production rate data 
used by the US Food and Drug Administration; 
(c) no information available on mutagenicity and genotoxicity; 
(d) no information available on DNA adducts and DNA damage; 
(e) inadequate evidence for carcinogenicity in humans;  
(f) regarding effects of progesterone on gr owth and reproduction, alterations of 
spermatogenesis can be induced by progest erone treatments, but no assessment of the 
dose-response relationship is available; 
(g) regarding effects on the immune system, there are data indicating that progesterone 
can cause immuno depression, but they are in sufficient to make a realistic assessment 
of the dose-response relationship. 
7.704  In response to Canada's reference to the 1999 JECFA assessment, the European Communities 
notes that the 1999 Opinion took JECFA's assessm ent into account, expressing concern regarding the 
determination of the ADI since neither the actual data nor a reference to a peer-reviewed publication were provided, and since the dose-response was li mited to two doses and the ADI was estimated from 
just a single dose rather than a curv e derived from all the data available.
802 
7.705  In addition, the European Communities indicates  that the Opinions, in particular the 2002 
Opinion, have taken the 1999 CVMP assessment into account.  The European Communities argues 
that the CVMP opinion was not used as the only basi s of the EC measure for progesterone as a growth 
promoter because new scientific evidence had appeared since and the SCVPH assessment had identified risks that were incompatible with the le vel of health protection applied by the European 
Communities to these hormones when used for animal growth promotion purposes.  Secondly, the 
European Communities argues that the CVMP conclu sion applies only when progesterone is used in 
veterinary medicinal  products authorized in accordance with relevant EC legislation, which would 
exclude over the counter products freely available to laypeople.
803    
Reasoning of the Panel  
7.706  In light of the arguments of the parties, a nd having regard to the 1999 and 2002 Opinions804 
and to the fact that some of the insufficiencies identified by th e European Communities have been 
addressed in the common section above or were si mply not discussed by the European Communities 
in its submissions, the Panel will limit its analysis to determining whether relevant scientific evidence 
is insufficient concerning progesterone with rega rd to evidence of carcinogenicity in humans. 
                                                      
802 EC's second written submission, para. 155; EC's re plies to Panel questions after the first substantive 
meeting, question 22, para.126, Annex B-1. 
803 EC's second written submission, para. 89; EC's rep lies to Panel questions after the first substantive 
meeting, question 23, paras. 130-133, Annex B-1. 
804 The 2000 Opinion did not identify essentially new toxicological information concerning 
progesterone and testosterone in the data presented in the toxicological evaluation of the natural hormones 
oestradiol-17 β, progesterone and testosterone in animal production by JECFA (2000 Opinion, section 2.2, p. 4).  WT/DS321/R 
 Page 277 
 
 
  7.707  We note that the European Communities, referri ng to the 1999 Opinion, argues that there is 
no information available on the mutagenicity and genotoxicity of progesterone.805 
7.708  We recall, however, that with respect to ge notoxicity, the 2002 Opinion concludes that 
"[t]here is no evidence that progesterone or  testosterone have genotoxic potential."806  
7.709  Regarding this aspect, we note that Dr. Boi sseau quoted the report of JECFA in its thirty-
second session (1999), where it concludes that "[a]lt hough equivocal results have been reported for 
the induction of single-strand DNA breaks and DNA adduc ts have been seen in vivo and in vitro in 
some studies, progesterone was not mutagenic … progesterone has no genotoxic potential ". Dr. Boisseau also quotes JECFA's conclusion that "t hese effects on tumour production occurred only 
with doses of progesterone causing obvious hormonal e ffects … the effect of progesterone on tumour 
production was directly relate d to its hormonal activity".
807 
7.710  Dr. Boobis concurred with the above by saying that: 
"there is no evidence that the hormones test osterone or progester one have genotoxic 
potential.  ...  Micronuclei can arise via a non-genotoxic mechanism, particularly at concentrations that may have caused some toxicity.  In addition, the 32P-post-
labelling assay is not specific, and data cited above suggest that DNA adduction can 
arise by mechanisms other than direct interaction with DNA.  In no case did any of the compounds produce a mutagenic response.   These data are insufficient to support 
the conclusion that these hormones have genot oxic potential in vivo.  Thus, there is 
no evidence that any of the hormones are genotoxic in vivo at the levels found in meat from treated animals.  Even if GVP we re not followed, the levels of exposure to 
the hormones would be such that no geno toxicity would be anticipated in vivo."
808 
7.711  Dr. Guttenplan added that "there is no c onclusive evidence presen ted by the European 
Communities that the five hormones other than oestradiol-17 β, when consumed as residues in meat 
have genotoxic potential.  There is some eviden ce that certain of the hormones have genotoxic 
potential, but generally the potential is weak. ... pr ogesterone [is] negative in genotoxic assays. ... Any 
genotoxic effects of the five hormones are likely to be minimized by good veterinary practice."809  
7.712  The European Communities considers that JECF A was more prudent than the experts when 
rejecting the genotoxicity of progesterone in 1999.   The European Communities further argues that 
the 1999, 2000 and 2002 risk assessments by the SCVPH provide enough evidence to demonstrate 
that genotoxicity from these hormones is possible.810 
7.713  We note that, on the one hand, the SCVPH in its 2002 Opinion concluded "[t]here is no 
evidence that progesterone or testosterone have genot oxic potential".  We note, on the other hand, that 
the European Communities did not point to any st udy subsequent to the 2002 Opinion which would 
contradict this conclusion. 
7.714  Regarding evidence of carcinogenicity in humans, we note that IARC has evaluated 
progestins as possibly carcinogenic to humans  (Group 2B)811 based on sufficient evidence of 
                                                      
805 EC's second written submission quoting 1999 Opinion, paras. 150-152. 
806 2000 Opinion, section 4.3, p. 15. 
807 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 157. 
808 Reply of Dr. Boobis to question 21 of the Panel, Annex D, para. 198. 
809 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200. 
810 EC's comments to experts' replies to Panel question 21, Annex F-1, p. 18. 
811 In its reply to question 24 of the Panel, Annex E-3, p. 128, IARC mentioned that it uses the 
following groupings to characterize potential carcinogenic agents: WT/DS321/R 
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  carcinogenicity in experimental animals.812 We note, however, that IARC's evaluation relates to the 
carcinogenicity of hormones in general, not to the carcinogenicity due to exposure to hormone 
residues in meat and meat products as a result of  the cattle being treated with growth promoting 
hormones.  
7.715  Dr. Boisseau mentioned that "[i]n its 1999 report, SCVPH concluded, about the 
carcinogenicity of progesterone, that 'At present, th e data are insufficient to make any quantitative 
estimate of the risk arising from th e 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."
813 
7.716  On the basis of the arguments of the parties a nd of the experts' opinions, we conclude that 
there is no 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.  We therefore conclude that the elemen ts before us do not suppor t the conclusion that  the 
relevant scientific evidence has become insufficien t, within the meaning of Article 5.7 of the 
SPS Agreement , regarding the genotoxicity, mutagenic ity and carcinogenicity of progesterone. 
Conclusion  
7.717  Having regard to our specific conclusions above, we recall that the Appellate Body clarified 
in Japan – Apples  that relevant scientific evidence will be insufficient within the meaning of 
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative 
terms, the performance of an adequate assessment of  risks as required under Article 5.1.  In this 
respect, we note that, at our request, the experts also expressed their views on the more general question whether the scientific evidence available at  the time of the adoption of Directive 2003/74/EC 
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated, 
inter alia,  with progesterone.  Dr. Boobis replied that: 
"[T]here was sufficient information availabl e to the EC to have enabled it to have 
conducted an assessment of the risks to human  health arising from consumption of 
meat from cattle treated with any of the six hormones at issue."  
                                                                                                                                                                    
 
 
"Carcinogenic to humans  (Group 1).  This category is used when there is sufficient evidence of 
carcinogenicity  in humans. 
 
Probably carcinogenic to humans  (Group 2A).  This category is  generally used when there is limited 
evidence  in humans and sufficient evidence  in experimental animals. 
 
Possibly carcinogenic to humans  (Group 2B).  This category is generally used when there is limited 
evidence  in humans or sufficient evidence  in experimental animals, but not both. 
 
Not classifiable as to its carcinogenicity to humans  (Group 3).  This category is generally used when 
there is inadequate evidence  in humans and inadequate  or limited evidence  in experimental animals.  
Agents that do not fall into any other group are also placed in this category. 
 
Probably not carcinogenic to humans  (Group 4).  This category is generally used when there is 
evidence suggesting lack of carcinogenicity  in humans and in experimental animals. 
 Mechanistic and other relevant data also contribute to the grouping.  Further details can be found in the 
Preamble to the IARC Monographs  (http://monographs.iarc.fr)." 
 
812 IARC reply to question 25 of the Panel, Annex E-3, p. 129. 
813 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 158.  WT/DS321/R 
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  7.718  We also note Dr. Guttenplan's comment that: 
"Progesterone, testosterone have been ex tensively investigated and the assessment 
seems sound and is based on the no effect level and a safety factor.  (JECFA meeting 52, report-WHA TRS 893)."  
7.719  These general remarks support our conclusions on the specific elements discussed above.  We 
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with 
respect to progesterone, within the meaning of Article 5.7 of the SPS Agreement . 
(viii) Is relevant scientific evidence insufficient in the case of testosterone? 
Summary of the main arguments of the parties
814 
7.720  Canada  argues that, as early as 1981, JECFA evaluated the health effects of residue levels 
present in human food obtained from animals trea ted with the naturally occurring hormones, i.e. 
oestradiol-17 β, progesterone and testosterone. In the Re port of its twenty-fifth meeting, JECFA 
concluded that residues from the use of these hormones according to good veterinary practices are unlikely to pose a hazard to human health. In 1989, JECFA published the residue monographs for 
testosterone and progesterone from its thirty-second  meeting in June 1987. Each of these reports 
reviewed several relevant scientific studies on resi due levels of these hormones in meat derived from 
treated animals. 
7.721  Canada recalls that, in February 1999, JE CFA conducted its most recent comprehensive 
evaluation of these three naturally occurring hormon es. In the Report of its thirty-second meeting, 
JECFA recommended ADI levels for all three of th ese substances. JECFA's most recent residue and 
toxicological monographs for testosterone, progesterone and oestradiol-17 β, published in 2000, 
reference the large number of studies relied on by JECFA to recommend ADIs for these hormones.
815 
7.722  Canada further notes that JECFA has found that "t estosterone is generally considered to be 
inactive when given by the oral route owing to gastrointestinal and/or hepatic inactivation." 
Testosterone's low bioavailability dramatically re duces the amount of testosterone which would be 
available for conversion to estradiol. It should also be noted that hormones such as progesterone and testosterone are endogenously produced chemicals a nd thus it is unlikely that their transformation 
products would be of concern.
816 
7.723  Canada concludes that it is evident, based on the scientific data contained in these JECFA 
reports and the recommended ADIs for these substan ces, that JECFA does not consider that residues 
of these hormones have an adverse effect on human health, provided they are used in accordance with 
good veterinary practices. Canada concludes that , faced with this conclusion from JECFA, the 
European Communities cannot substant iate its assertion that there is insufficient scientific information 
to perform an adequate risk assessment in respect of these five hormones.817 
7.724  The European Communities , quoting the 1999 Opinion, identifies the following 
insufficiencies in the evidence regarding testosterone:818 
                                                      
814 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
815 Canada's first written submission, paras. 116-124. 
816 Canada's second written submission, para. 134. 
817 Canada's first written submission, paras. 116-124. 
818 EC's second written submission, paras. 153-155. WT/DS321/R 
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  (a) the mechanism of androgen activity is only partially understood, including the role of 
androgen receptors in ovarian tumorigenesis; 
(b) little information is available about the speci fic metabolic routes and elimination rates 
for testosterone in cattle; 
(c) there is uncertainty regarding daily production rate data;  
(d) genotoxicity of testosterone has not been demonstrated with the limited testing done 
to date; 
(e) no information is available on DNA damage induced by testosterone or its 
metabolites; 
(f) data on carcinogenicity in humans are limited;819 
(g) no dose-response estimate can be given fo r effects on growth and reproduction; 
(h) there is limited experimental data on the e ffects of testosterone on the immune system 
and none on dose-response aspects.   
7.725  In response to Canada's reference to the 1999 JECFA assessment, the European Communities 
notes that the 1999 Opinion questions the quality of the study that provided the data for JECFA's 
determination of the ADI.  According to the Eu ropean Communities, neither the actual data nor 
reference to a peer-reviewed publication were provi ded, the dose-response was limited to two doses 
and the ADI was estimated from just a single dose wh ere no effect was observed rather than a curve 
derived from all the data available.820 
Reasoning of the Panel  
7.726  In light of the arguments of the parties, a nd having regard to the 1999 and 2002 Opinions821 
and to the fact that some of the insufficiencies identified by th e European Communities have been 
addressed in the common section above, or were si mply not discussed by the European Communities 
in its submissions, the Panel does not deem it necessary to address the mechanism of androgen 
activity, the metabolic routes and elimination rates for testosterone in cattle or the daily production 
rate data since these issues have either not been  discussed specifically by the parties, or were 
addressed above. 
7.727  We also note that the 1999 Opinion found that genotoxicity of testosterone has not been 
demonstrated with the limited testing done to date.822 The 2002 Opinion adds that "[t]here is no 
evidence that progesterone or testosterone have genotoxic potential."823 
                                                      
819 In its conclusion on carcinogenicity, the SCVPH notes that evidence about the role of endogenous 
testosterone in the occurrence of prostate cancer is weak, that there is limited data on genotoxicity but that 
testosterone might be aromatized to oestradiol, which had been found to be genotoxic, and that no conclusive quantitative estimate of the risk arising from the excess in take with meat and meat products from treated animals 
can be made.   
820 EC's second written submission, para. 155;  EC's re plies to Panel questions after the first substantive 
meeting, question 22, Annex B-1, para. 124. 
821 The 2000 Opinion did not identify essentially new toxicological information concerning 
progesterone and testosterone in the data presented in the toxicological evaluation of the natural hormones 
oestradiol-17 β, progesterone and testosterone in animal production by JECFA (2000 Opinion, section 2.2, p. 4). 
822 1999 Opinion, section 4.2.5. 
823 2000 Opinion, section 4.3, p. 15. This was confirmed by the experts who expressed views on this 
question. For instance, Dr. Guttenplan mentioned that: "there is no conclusive evidence presented by the EC that  WT/DS321/R 
 Page 281 
 
 
  7.728  Likewise, the 1999 Opinion states that no info rmation is available on DNA damage induced 
by testosterone or its metabolites.824 This said, it states that "testosterone is ... aromatized to 
oestradiol, which is metabolized to reactive fo rms that damage DNA and induce mutation."  The 
1999 Opinion then refers to its section on oestradiol-17 β. 
7.729  The 1999 Opinion also reports that "[W]hereas the evidence in favour of carcinogenicity was 
considered sufficient for testosterone in experi mental animals, data in humans are limited."825  This 
reference has to be read in conjunction with the following paragraph of the 1999 Opinion, which 
states that the evidence regarding the role of testos terone in prostate cancer is currently weak.  In 
addition, it seems to relate to endogenous testosterone.  The 1999 Opinion adds that no conclusive 
quantitative estimate of the risk arising from the excess intake with meat and meat products from 
treated animals can be made. 
7.730  These comments do not, in our opinion, meet our test that there be a critical mass of new 
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge 
and evidence to make relevant, previously sufficien t, evidence now insufficient and would lead us to 
consider that no risk assessment could be performed.  We note in this respect that the 1999 Opinion 
notes that testosterone is "considered as pr obable carcinogenic to humans (IARC group 2A)".826  
IARC specified that "this category is generally used  when there is limited evidence in humans and 
sufficient evidence in experimental animals."827  We also note that IARC assessments are made in 
general terms, not specifically in relation to cons umption of meat treated with hormones for growth 
promotion purposes. 
7.731  Regarding carcinogenicity of testosterone, Dr . Boisseau mentioned that IARC confirms the 
1999 Opinion to the extent that it has determined that there is sufficient evidence of carcinogenicity  in 
experimental animals and advised, "In the absence of adequate data in humans, it is reasonable, for 
practical purposes, to regard testosterone as if it presented a carcinogenic risk to humans".828  
7.732  Dr. Boisseau also stated that "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."
829 
7.733  Having regard to the positions taken by the SCVPH in its 1999 and 2002 Opinions and the 
views expressed by the experts, we do not find it ne cessary to address any further the questions of the 
genotoxicity and carcinogencity of testosterone in  our attempt at determ ining whether relevant 
scientific evidence is insufficient w ith respect to this hormone, within the meaning of Article 5.7 of 
the SPS Agreement . 
Conclusion  
7.734  Having regard to our specific conclusions above, we recall that the Appellate Body clarified 
in Japan – Apples  that relevant scientific evidence will be insufficient within the meaning of 
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative 
terms, the performance of an ade quate assessment of risks as required under Article 5.1.  In this 
respect, we note that, at our request, the expert s also expressed their views on the more general 
                                                                                                                                                                     
the five hormones other than oestradiol-17 β, when consumed as residues in meat have genotoxic potential."  
Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200. 
824 EC's second written submission, para. 153, quoting 1999 Opinion, pp. 45-51. 
825 EC's second written submission, para. 153, quoting 1999 Opinion, pp. 45-51. 
826 1999 Opinion, section 4.2.7. 
827 See IARC reply to question 24 of the Panel, Annex E-3, p. 128. 
828 IARC reply to question 25 of the Panel, Annex E-3, p. 129. 
829 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 160. WT/DS321/R 
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  question whether the scientific evidence available at  the time of the adoption of Directive 2003/74/EC 
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated, 
inter alia,  with testosterone.  Dr. Boobis replied that: 
"[T]here was sufficient information availabl e to the EC to have enabled it to have 
conducted an assessment of the risks to human  health arising from consumption of 
meat from cattle treated with any of the six hormones at issue."  
7.735  We also note Dr. Guttenplan's comment that: 
"Progesterone, testosterone have been ex tensively investigated and the assessment 
seems sound and is based on the no effect level and a safety factor.  (JECFA 
meeting 52, report-WHA TRS 893)."  
7.736  These general remarks support our conclusions on the specific elements discussed above.  We 
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with 
respect to testosterone, within the meaning of Article 5.7 of the SPS Agreement . 
(ix) Is relevant scientific evidence insufficient  in the case of trenbolone acetate? 
Summary of the main arguments of the parties830 
7.737  Canada  argues that trenbolone acetate and zeranol were first considered by JECFA in 1982 
and again in 1983. In 1987, JECFA prepared resi due and toxicity monographs for trenbolone acetate 
and zeranol.  In the Report of its thirty-sec ond meeting JECFA recommended an ADI for zeranol. 
Further residue and toxicity monographs were prepared by JECFA for its thirty-fourth meeting in 1989. Based on JECFA's analysis of the toxicolo gical data produced for this meeting, JECFA 
recommended an ADI for trenbolone acetate.
831 
7.738  Canada adds that JECFA reviewed genotoxicity and mutagenicity data for trenbolone acetate 
and its metabolites TBOH alpha and TBOH beta at its thirty-second and thirty-fourth meetings and 
concluded that it was unlikely that they were genotoxic.832 
7.739  Canada considers that, based on the scientific data contained in these JECFA reports and the 
recommended ADIs for these substances, JECFA does not consider that residues of these hormones have an adverse effect on human health, provided they are used in accordance with good veterinary 
practices. Canada concludes that, faced with this  conclusion from JECFA, the European Communities 
cannot substantiate its assertion that there is insuffi cient scientific information to perform an adequate 
risk assessment in respect of these five hormones.
833 
7.740  The European Communities , quoting the 1999 Opinion, identifies the following 
insufficiencies in th e scientific evidence:834    
(a) the need to further investigat e the metabolic fate and chemical nature of covalently 
bound residues of trenbolone acetate;835   
                                                      
830 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
831 Canada's first written submission, paras. 116-124. 
832 Canada's second written submission, para. 135. 
833 Canada's first written submission, paras. 116-124. 
834 EC's second written submission, paras. 156-157. 
835 EC's second written submission, para. 156, quoting 1999 Opinion, pp. 55-60.  WT/DS321/R 
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  (b) in humans, no data are currently availabl e to assess the carcinogenicity of trenbolone 
acetate;836   
(c) regarding effects on reproduction, the av ailable data do not allow a realistic 
assessment of a dose-response relationship; 
(d) investigations of the effects of trenbolone acetate on the immune system are very 
limited.   
7.741  The European Communities adds that the SC VPH concluded that the information is 
insufficient to assess the possible im pacts of low levels of trenbolone acetate in meat on consumers.  
7.742  The European Communities indicates that, in its 2002 Opinion, th e SCVPH found these 
conclusions to be compounded by da ta obtained in certain of the 17 studies and more recent research, 
none of which was considered by the 1988 JECFA re port.  The European Communities argues that the 
only assessment on trenbolone acetate publicly available is that of JECFA, and that the SCVPH took 
this assessment into account, but di sagreed with a number of its basic findings on the basis of more 
recent scientific research.837 
Reasoning of the Panel  
7.743  In light of the arguments of the parties and of  the fact that some of the insufficiencies 
identified by the European Comm unities have been addressed in th e common section above, or were 
simply not discussed by the European Communities in  its submissions, the Panel will limit its analysis 
to determining whether relevant scientific eviden ce is insufficient concerning trenbolone acetate with 
regard to the following aspects: 
(a) metabolism of trenbolone acetate; 
(b) inadequate evidence of carcinogenicity in humans. 
Metabolism of trenbolone acetate 
7.744  The European Communities refers to the 2002 Op inion which states that "experiments with 
zeranol and trenbolone acetate suggested a more  complex oxidative metabolism than previously 
assumed. These data need further clarification as they might influence a risk assessment related to 
tissue residues of these compounds."838 
7.745  We note that Dr. Boobis discussed study 4 of the 17 studies:839 
"The metabolism of zeranol and trenbolone ha d been further investigated (study 4).  
These data do not appear to have been pub lished in the peer reviewed literature to 
date. 
                                                      
836 In its conclusion on carcinogenicity, the SCVPH notes that in consideration of the lack of in vitro  
short-term assays on mutagenicity and genotoxicity of  certain TBOH metabolites and in consideration of the 
equivocal results of cell transformation assays and the in vivo  studies, the available information is insufficient to 
complete a quantitative risk assessment. 1999 Opinion, section 4.4.7, p. 59. 
837 EC's second written submission, paras. 156-157; EC's replies to Panel questions after the first 
substantive meeting, question 22, Annex B-1, para. 126. 
838 EC's second written submission, para. 156, quoting 1999 Opinion at pp. 55-60. 
839 2002 Opinion, section 7, p. 21. WT/DS321/R 
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  The data on trenbolone show that the alpha  enantiomer in liver slices from bovine is 
extensively conjugated and hence inactivated.  There is some conversion of the alpha 
to the active beta isomer by human liver microsomes, but the kinetics of the reaction and the extent of conjugation have not been determined.  No data  were presented on 
levels of the alpha enantiomer in meat fro m treated cattle.  However, these data do 
not affect the risk assessment of trenbol one acetate.  This is because a) the 
toxicological studies were conducted in animal s that would have been exposed to the 
metabolites of concern, b) JECFA considered residues of both the alpha and the beta enantiomers in recommending MRLs for trenbolone acetate."
840  
7.746  No other expert expressed views on the subject. 
7.747  The Panel is cognizant that the European Communities argues that Dr. Boobis' comments on 
a number of the studies generated by the European Communities are flawed and has given examples 
of those alleged flaws.841  However, it does not expressly address Dr. Boobis' comments on the study 
discussed above.  As a result, the Panel sees no reas on not to take the comments of Dr. Boobis fully 
into account in its assessment of the sufficiency of existing relevant scientific evidence.   
Inadequate evidence of carcinogenicity in humans 
7.748  The European Communities refers to the 1999 Opinion which recalls that trenbolone acetate 
is a synthetic androgen and that both the parent compound and its metabolite have been extensively 
tested for their mutagenic/genotoxic potential.  The 1999 Opinion notes that it might be concluded 
that the genotoxic effects of trenbolone acetate are not  related to their hormonal activity.  It notes that 
"[f]ormation of DNA adducts has been observed in rat hepatocytes ... (Metzler, 1999)." On 
carcinogenicity, the 1999 Opinion mentions inter alia  that a two-year carcinogenesis842 bioassay in 
rats and mice did not provide definitive results.  In  humans, no data are currently available to assess 
the carcinogenicity of trenbolone acetate.  The 1999 Opinion concludes that th e available information 
is insufficient to complete a quantitative risk assessment.843 
7.749  Regarding this aspect,  Dr. Boisseau mentioned the following: 
"In its thirty second session held in 1987 , JECFA concluded from carcinogenic 
studies in animals that "the liver hyperplasia and tumours in mice … and the slight 
increase in the incidence of islet-cell of the pancreas of rats arose as a consequence of 
the hormonal activity of trenbolone". In its thirty fourth session held in 1989, JECFA, 
having reviewed a comprehensive battery of short term tests, concluded that 'it was 
unlikely that trenbolone acetate was genotoxic' and decided to confirm its previous 
                                                      
840 Reply of Dr. Boobis to question 62 of the Panel, Annex D, paras. 479-480. 
841 EC's comments on the replies of the experts, Annex F-1, p. 40. 
842 Mechanism (or mode of action) of carcinogenesis: a mode of action is series of key events which 
are necessary to lead to the formation of a tumour.  These key events comprise the biological changes induced 
by the chemical and subsequent events which then lead to the development of cancer.  A mechanism refers to 
the molecular events that are responsible for those changes.  A hormonal mechanism means that it is the 
endocrine or hormonal effect of a compound that leads to growth or proliferation of certain cells that are responsive to the hormone, resulting in the development of a tumour.  A genotoxic m echanism means that there 
is a mechanism independent of the hormonal action resulting in direct damage to the DNA that leads to a 
tumour.  There are situations where elements of more than one mechanism could apply (Transcript of the Panel 
meeting with the experts, (Dr. Boobis, Dr. Cogliano and Dr. Guttenplan), Annex G, paras. 103-109). 
843 1999 Opinion, pp. 57-59.  WT/DS321/R 
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  conclusion to base the evaluation of trenbolone acetate and its metabolites on their 
no-hormonal-effect."844 
7.750  The 2002 Opinion refers to the results of study 2 of the 17 studies with respect to 
mutagenicity and genotoxicity (Metzler and Pfeiffer, 2001).845  
7.751  Three experts expressed their views in relation to the subject of this study.  Dr. Boobis 
mentions the following: 
"There is no convincing evidence that trenbolone acetate, MGA and zeranol are 
genotoxic.  They were negative in a range of tests for genotoxicity.  They were very 
weakly positive in a micronucleus test, at high (potentially cytotoxic) concentrations.  
Trenbolone also produced a low level of DNA adducts measured by 32P-post-
labelling (Metzler and Pfeiffer, 2001) .846  As indicated above, micronuclei can arise 
via a non-genotoxic mechanism, particularly at concentrations that may have caused 
some toxicity.  In addition, the 32P-post-la belling assay is not specific, and data cited 
above suggest that DNA adduction can arise by mechanisms other than direct 
interaction with DNA.  In no case did a ny of the compounds produce a mutagenic 
response.  These data are insufficient to support the conclusion that these hormones have genotoxic potential in vivo.  Thus, th ere is no evidence that any of the hormones 
are genotoxic in vivo at the levels found in meat from treated animals.  Even if GVP 
were not followed, the levels of exposur e to the hormones would be such that no 
genotoxicity would be anticipated in vivo."
847 
7.752  Dr. Boobis added that: 
"Study 4 reports recent observations on the genotoxicity and mutage nicity of zeranol 
and trenbolone.  Both compounds were ne gative for tests of mutagenicity, i.e. 
induction of lacI mutations in E coli  and induction of hprt mutations inV79 cells.  
Zeranol did not produce DNA adducts in ra t hepatocytes whilst a low level of DNA 
adducts was observed with trenbolone.  Both were very weakly positive in a 
micronucleus test, at high (potentially cytotoxic) concentrations.  As indicated above 
..., micronuclei can arise via a non-genotoxic mechanism, particularly at concentrations that may have caused some toxicity.  In addition, the 32P-post-
labelling assay is not specific, and data cited above suggest that DNA adduction can 
arise by mechanisms other than direct interaction with DNA.  These data are insufficient, given the number of well conducted studies in which the compounds 
were negative, to alter the conclusion that  neither zeranol nor trenbolone acetate has 
genotoxic potential in vivo.  Indeed, the SVCPH (2002)  concluded that "both 
compounds exhibited only very weak effects" in those in vitro tests in which positive 
effects were observed."
848 
7.753  Dr. Guttenplan confirmed the conclusions of the two other experts: 
"[t]here is no conclusive evidence presented  by the EC that the five hormones other 
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.  
                                                      
844 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 163. 
845 2002 Opinion, section 4.4.3. 
846 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth 
promoters and their metabolites. APMIS, 109:89-95 
847 Reply of Dr. Boobis to question 21 of the Panel, Annex D, para. 198. 
848 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 483. WT/DS321/R 
Page 286 
 
 
  There is some evidence that certain of the hormones have genotoxic potential, but 
generally the potential is weak. ... Trenbolone  is either negative or marginally active 
in in vitro genotoxic assays. ... Any genotoxic effects of the five hormones are likely 
to be minimized by good veterinary practice. My reply for the hormones would not 
have been different in Sept ember 2003 (SCVPH 2002 Opinion)."849  
7.754  The European Communities argu es essentially that the 1999, 2000 and 2002 Opinions provide 
enough evidence to demonstrate that genotoxicity an d other adverse effects from these hormones are 
possible and that there are a number of uncertainti es surrounding their mechanism of action to warrant 
further investigations.  The European Comm unities refers to Dr. Guttenplan's statement.850 
7.755  We do not read the statement above as the European Communities does.  Rather we 
understand Dr. Guttenplan to say that the genotoxic  potential of trenbolone acetate is weak.   
7.756  Regarding carcinogenicity, we first note that trenbolone acetate has not been evaluated by 
IARC, nor have the specific risks from the consumpti on of meat from cattle treated with this growth 
promotion hormone.851 
7.757  Dr. Boisseau made the following comments:  
"In its 1999 report, SCVPH concluded, about the carcinogenicity of trenbolone, that 
'in consideration of the lack of in vitr o short term assays on mutagenicity and 
genotoxicity of other trenbolone metabolites other than α-trenbolone and in 
consideration of the equivocal results of  the transformation assays and the in vivo 
studies, the available information is insu fficient to complete a quantitative risk 
assessment'. Therefore,  the scientific evidence relied upon in the SCVPH Opinions 
does not support the conclusion that the car cinogenic effects of trenbolone are related 
to a mechanism other than hormonal activity."852 
7.758  The European Communities seeks to refute Dr. Boisseau's co mments on the basis that he 
refers only to  the JECFA's reports, which are outdate d and based on old data, and that he interprets 
lack of data as lack of adverse effects. 
7.759  We recall our test in order to assess whether releva nt scientific evidence is insufficient is that 
there should be 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.  We note that the European Commun ities points at possibilities which are not confirmed 
by the experts who expressed their views.  We theref ore conclude that the elements before us do not 
support the conclusion that  the relevant scientific  evidence has become in sufficient, within the 
meaning of Article 5.7 of the SPS Agreement , regarding the carcinogenicity of trenbolone acetate. 
Conclusion  
7.760  Having regard to our specific conclusions above, we recall that the Appellate Body clarified 
in Japan – Apples  that relevant scientific evidence will be insufficient within the meaning of 
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative 
terms, the performance of an adequate assessment of  risks as required under Article 5.1.  In this 
respect, we note that, at our request, the experts also expressed their views on the more general 
                                                      
849 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200. 
850 EC's comments on replies to question 21 of the experts, Annex F-1, p. 18. 
851 IARC reply to question 25 of the Panel, Annex E-3, p. 129. 
852 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 164.  WT/DS321/R 
 Page 287 
 
 
  question whether the scientific evidence available at  the time of the adoption of Directive 2003/74/EC 
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated, 
inter alia,  with trenbolone acetate.  Dr. Boobis replied that: 
"[T]here was sufficient information availabl e to the EC to have enabled it to have 
conducted an assessment of the risks to human  health arising from consumption of 
meat from cattle treated with any of the six hormones at issue."  
7.761  We also note Dr. Guttenplan's comment that: 
"There is more limited evidence available for Trenbolone and Zera nol and most of it 
is in vitro  (SCVPH 2002 Opinion ) or not recent (e.g., JECFA meeting 34th report, 
1989 and 32nd report, 1988).  However, both appear to be potentially significantly 
estrogenic.  Experimental and analytic al methods have improved but it does not 
appear that accurate ADI's can be established at this point.  Studies in experimental 
animals and studies on levels in beef ar e still needed.  However, from the data 
available at the time of the Directive, th e potential for adverse effects could not be 
ruled out."853  
7.762  We note, however, that during our meeting with the experts, Dr. Guttenplan clarified, at the 
EC request, that "the ability [to make a risk assess ment] varies between compounds, but that does not 
mean that you can't make a risk assessment, it just means that the accuracy of the risk assessment is 
different."854  Regarding the establishment of accurate ADI s, Dr. Guttenplan clarified that "accurate 
means – if it's not accurate, there is just a la rger range, but you can still do a risk assessment."855  
7.763  These general remarks support our conclusions on the specific elements discussed above.  We 
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with 
respect to trenbolone acetate, within the meaning of Article 5.7 of the SPS Agreement . 
(x) Is relevant scientific evidence insufficient in the case of zeranol 
Summary of the main arguments of the parties856 
7.764  Canada  recalls that trenbolone acetate and zeranol were first considered by JECFA in 1982 
and again in 1983.  In 1987, JECFA prepared resi due and toxicity monogra phs for trenbolone acetate 
and zeranol. In the Report of its thirty-second meeting JECFA recommended an ADI for zeranol. 
Further residue and toxicity monographs were prepared by JECFA for its thirty-fourth meeting in 
1989. Based on JECFA's analysis of the toxicolo gical data produced for this meeting, JECFA 
recommended an ADI for trenbolone acetate.857 
7.765  Canada adds that JECFA has found that zeranol  and its metabolites zearalanone and taleranol 
not to be mutagenic in a number of tests in bacterial and mammalian systems.858 
7.766  In Canada's opinion, it is evident, based on  the scientific data contained in these JECFA 
reports and the recommended ADIs for these substan ces, that JECFA does not consider that residues 
                                                      
853 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 457. 
854 Transcript of the Panel meeting with the experts, Annex G, para. 983. 
855 Transcript of the Panel meeting with the experts, Annex G, para. 985. 
856 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
857 Canada's first written submission, paras. 116-124. 
858 Canada's second written submission, para. 135. WT/DS321/R 
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  of these hormones have an adverse effect on human health, provided they are used in accordance with 
good veterinary practices. Canada concludes that , faced with this conclusion from JECFA, the 
European Communities cannot substant iate its assertion that there is insufficient scientific information 
to perform an adequate risk assessment in respect of these five hormones.859 
7.767  The European Communities , quoting the 1999 Opinion, identifies the following 
insufficiencies in the evidence:860  
(a) there are only few tests with equivocal results on the genotoxic properties of zeranol, 
which are insufficient for an evaluation of its mutagenic/genotoxic properties; 
(b) no data are available on cancer risk fo r humans linked to meat with zeranol 
residues;861   
(c) no dose-response relationship for effects of  zeranol on growth and reproduction can 
be made; 
(d) no relevant data on effects on the immune system were found.   
7.768  The European Communities notes that, in conclusion, the 1999 Opinion finds that the 
available data do not allow a quantitative estimate of the risk arising from exposure to zeranol 
residues, and that further data are needed on the nature of the metabolites formed in bovines. The 
European Communities indicates that in its 2002 Op inion, the SCVPH found these conclusions to be 
compounded by data obtained in certain of the 17 studies and more recent research.862 
7.769  The European Communities cites a study by US scientists according to which meat and serum 
from zeranol-implanted cattle possess "heat-stable mit ogenicity for cultured breast cells, and that both 
normal and cancerous human breast cells exhibit estrogenic responses to zeranol".863 These scientists 
then point to potential tumorigenic effects for oestrogen, including direct genotoxic effects of oestrogen metabolites.  They point out that the mechanisms responsible for oestrogen stimulated 
carcinogenesis remain undefined.  The European  Communities argues that these studies clearly 
invalidate the findings of the 1988 JECFA opinion.
864 
7.770  The European Communities also argues th at the only assessment on zeranol publicly 
available is that performed by JECFA in 1988.  The European Communities indicates that the SCVPH 
took this assessment into account, but disagreed with  a number of its basic findings on the basis of 
more recent scientific research, some of which was generated by the 17 studies865 (studies Nos. 2, 4 
and 10) and more recent research. 
                                                      
859 Canada's first written submission, paras. 116-124. 
860 EC's second written submission, paras. 158-160. 
861 In its conclusion on carcinogenicity, the SCVP H states that considering the limited data on 
mutagenicity/genotoxicity and the clear evidence for an induction of liver ad enomas and carcinomas in 
hamsters, no assessment of the possible carcinogenicity of zeranol can be made .  See 1999 Opinion, 
section 4.5.7, p. 65. 
862 EC's second written submission, paras. 158-160. 
863 EC's second written submission, paras. 139-140, citing a study by Suling Liu and Young C. Lin, 
Exhibit EC-8. 
864 EC's second written submission, para. 160. 
865 EC's second written submission, paras. 158-159; EC's replies to Panel questions after the first 
substantive meeting, question 22, Annex B-1, para. 126.  WT/DS321/R 
 Page 289 
 
 
  Reasoning of the Panel  
7.771  In light of the arguments of the parties and of  the fact that some of the insufficiencies 
identified by the European Comm unities have been addressed in th e common section above, or were 
simply not discussed by the European Communities in  its submissions, the Panel will limit its analysis 
to determining whether relevant scientific evidence is insufficient concerning zeranol with regard to 
the alleged  inadequate evidence of carcinogenicity in humans, such as lack of information available 
on mutagenicity and genotoxicity and lack of  information on DNA adducts and DNA damages. 
7.772  The 1999 Opinion referred to by the European Communities states that the mutagenicity and 
genotoxicity of zeranol was investigated only in a few tests which gave equivocal results insufficient 
for an evaluation of the mutagenic/genotoxic prope rties of zeranol. As far as carcinogenicity is 
concerned, the 1999 Opinion concludes that ther e is clear evidence for the induction of liver 
adenomas and carcinomas in one animal species, but no assessment of the possible carcinogenicity of 
zeranol can be made.866 
7.773  Five experts provided views on this matter.  Dr. Cogliano limited his comments to the study 
by Norat et al. (2005)867, one of the three recently publishe d studies on which the Panel sought the 
views of the experts, which addresses the association between consumption of red meat and colorectal 
cancer.  The comments by Dr. Cogliano are not specifi c with respect to the question of the potential 
carcinogenicity of zeranol. 
7.774  Dr. Boisseau expressed the following opinion: 
"In its thirty second session held in 1987,  JECFA concluded that zeranol and its 
metabolites, zearalanone and taleranol, were not mutagenic in a number of tests in 
bacterial and mammalian systems even if it has noted that zeranol gives a positive 
result in the Rec-assay and taleranol giv es a positive result in the test with Chinese 
hamster ovary cells in the absence of activa tion but a negative result with activation. 
After having reviewed the carcinogenicity st udies in animals, JECFA concluded that 
'the tumorigenic effect of zeranol was associated with its oestrogenic properties'."868 
7.775  The 2002 Opinion refers to a comparative study (study 4 of the 17 studies) designed to 
determine the potential of zeranol, trenbolone and melengestrol acetate to ca use genetic damages in 
various in vitro  systems.  The 2002 Opinion states that  "[i]n this study zeranol did not induce 
genotoxicity or mutagenicity."869 
7.776  Dr. Sippell mentioned that "[S]ynthetic hormone  growth promoters such as Zeranol and its 
metabolites have been shown to be as potent as [est radiol] and diethylstilbestrol (DES) in increasing 
the expression of estrogen-related genes in human breast cancer cells ( Leffers et al 2001  – 
study 17)."870  However, Dr. Boobis specified that: 
"The study referred to (study 17), reported in Leffers et al (2001) , showed that a 
number of oestogenic compounds affected th e expression of several genes in the ER 
positive breast cancer cell line, MCF7.  The responsiveness of this cell line to 
oestrogens is well established.  It was of interest that all of the changes reported by Leffers et al (2001)  were blocked by the selective ERantagonist ICI82.780.  The 
                                                     
 
866 1999 Opinion, sections 4.5.5 to 4.5.7. 
867 Exhibit EC-71. 
868 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 165. 
869 2002 Opinion, section 4.4.3, p. 16. 
870 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 336. WT/DS321/R 
Page 290 
 
 
  relevance of effects observed in a cultured cell line to the situation in vivo , where 
kinetic and metabolic factors will influen ce the magnitude of the response is not 
known, nor is the significance of changes in gene expression to the toxicity of the hormones known.  Many of the changes will reflect the proliferative response to an 
oestrogenic stimulus.  However, in genera l toxicogenomic data, in the absence on any 
information on the functional consequences, is not considered a sound basis for use in 
risk assessment (IPCS, 2003) ."
871 
7.777  Dr. Boobis added that: 
"There is no evidence that the hormones t estosterone or progesterone have genotoxic 
potential.  There is no convincing evidence that trenbolone acetate, MGA and zeranol 
are genotoxic.  They were negative in a range of tests for genotoxicity.  They were 
very weakly positive in a micronucleus test, at high (potentially cytotoxic) concentrations.  Trenbolone also produced  a low level of DNA adducts measured by 
32P-post-labelling (Metzler and Pfeiffer, 2001) .
872  As indicated above, micronuclei 
can arise via a non-genotoxic mechanism, particularly at concentrations that may 
have caused some toxicity.  In addition, the 32P-post-labelling assay is not specific, 
and data cited above suggest that DNA adduc tion can arise by mechanisms other than 
direct interaction with DNA.  In no case  did any of the compounds produce a 
mutagenic response.  These data are insuffi cient to support the conclusion that these 
hormones have genotoxic potential in vivo.  Thus, there is no evidence that any of the hormones are genotoxic in vivo at the levels  found in meat from treated animals.  
Even if GVP were not followed, the levels of exposure to the hormones would be 
such that no genotoxicity would be anticipated in vivo." 
7.778  Dr. Boobis, commenting on study 4, added the following: 
"Study 4 reports recent observations on the genotoxicity and mutage nicity of zeranol 
and trenbolone.  Both compounds were ne gative for tests of mutagenicity, i.e. 
induction of lacI mutations in E coli  and induction of hprt mutations inV79 cells.  
Zeranol did not produce DNA adducts in ra t hepatocytes whilst a low level of DNA 
adducts was observed with trenbolone.  Both were very weakly positive in a 
micronucleus test, at high (potentially cytotoxic) concentrations.  As indicated above 
..., micronuclei can arise via a non-genotoxic mechanism, particularly at 
concentrations that may have caused some toxicity.  In addition, the 32P-post-labelling assay is not specific, and data cited above suggest that DNA adduction can 
arise by mechanisms other than direct interaction with DNA.  These data are 
insufficient, given the number of well conducted studies in which the compounds were negative, to alter the conclusion that  neither zeranol nor trenbolone acetate has 
                                                     
 
871 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 475.  Dr. Boobis cites to: 
 
IPCS (2003).  Toxicogenomics and the Risk Assessment of Chemicals for the Protection of 
Human Health  
(http://www.who.int/entity/ipcs/methods/e n/toxicogenomicssummaryreport.pdf) 
 
Leffers H, Naesby M, Vendelbo B, Skakkebaek NE and Jorgensen M (2001).  Oestrogenic 
potencies of Zeranol, oestradiol, diethylstilboestrol, Bisphenol-A and genistein: implications 
for exposure assessment of potential endocrine disrupters .  Hum Reprod, 16:1037-1045.   
 
872 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth 
promoters and their metabolites. APMIS, 109:89-95.  See  Reply of Dr. Boobis to question 21 of the Panel, 
Annex D, para. 198.  WT/DS321/R 
 Page 291 
 
 
  genotoxic potential in vivo.  Indeed, the SVCPH (2002)  concluded that "both 
compounds exhibited only very weak effects" in those in vitro tests in which positive 
effects were observed."873 
7.779  Dr. Guttenplan commented in more general terms that: 
"There is no conclusive evidence presented by the EC that the five hormones other 
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.  
There is some evidence that certain of the hormones have genotoxic potential, but 
generally the potential is weak. .... Zeranol can induce transformation of breast 
epithelial cells in culture with efficiency  similar to that of estradiol, but the 
mechanism is not known, and it is negative or marginally active in other assays. ... 
Any genotoxic effects of the five hormone s are likely to be minimized by good 
veterinary practice. My reply for the hormones would not have been different in September 2003 ( SCVPH 2002 Opinion )."
874 
7.780  Regarding carcinogenicity of zeranol, Dr. Boisseau mentioned that: 
"In its 1999 report, SCVPH concluded, about the carcinogenicity of zeranol, that "in 
consideration of the lack of data on muta genicity/genotoxicity and the clear evidence 
for an induction of liver adenomas a nd carcinomas in one animal species, no 
assessment of the possible carcinogenicity of zeranol can be made". Therefore,  the 
scientific evidence relied upon in the SCVPH Opinions does not support the 
conclusion that the carcinogenic effects of zeranol are related to a mechanism other 
than hormonal activity."875 
7.781  Referring to the study by Liu S and Lin YC (2002)876, Dr. Guttenplan stated that: 
"The first of the studies suggests a risk from zeranol. That observation was not 
previously reported. However, the results  were obtained in cultured cells and the 
relevance to human exposure to hormone-tr eated cannot be extrapolated from this 
study because of a myriad of uncertainti es in such extrapolation. The study does 
suggest that additional tests of zeranol should be carried out. There is also some evidence that a metabolite of zeranol ( zearalenone) induces oxidative damage in 
cultured cells. This is a possible genotoxic effect, but again it cannot be extrapolated 
to meat consumption."
877 
7.782  Zeranol has not been evaluated by IARC, nor ha ve the specific risks from the consumption of 
meat from cattle treated with this growth promotion hormone.878 
7.783  The European Communities argues that Dr. Gutte nplan made a "careful and scientifically 
sound statement".879  We note, however, that Dr. Guttenplan concluded that a genotoxic effect cannot 
be extrapolated to meat consumption, because of th e "myriad of uncertainties" that such extrapolation 
would entail. 
                                                      
873 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 483. 
874 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200. 
875 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 166. 
876 Liu S and Lin YC (2004).  Transformation of MCF-10A human breast epithelial cells by zeranol 
and oestradiol-17beta.  Breast J, 10:514-521, Exhibit EC-62. 
877 Reply of Dr. Guttenplan to question 25 of the Panel, Annex D, para. 234. 
878 IARC reply to question 25 of the Panel, Annex E-3, p. 129. 
879 EC's comments on reply 25 to the questions of the Panel to the experts, Annex F-1, p. 21. WT/DS321/R 
Page 292 
 
 
  7.784  On the basis of the arguments of the parties and of the experts' opinions, we conclude 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 . 
Conclusion  
7.785  Having regard to our specific conclusions above, we recall that the Appellate Body clarified 
in Japan – Apples  that relevant scientific evidence will be insufficient within the meaning of 
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative 
terms, the performance of an adequate assessment of  risks as required under Article 5.1.  In this 
respect, we note that, at our request, the experts also expressed their views on the more general question whether the scientific evidence available at  the time of the adoption of Directive 2003/74/EC 
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated, 
inter alia,  with zeranol.  Dr. Boobis replied that: 
"[T]here was sufficient information availabl e to the EC to have enabled it to have 
conducted an assessment of the risks to human  health arising from consumption of 
meat from cattle treated with any of the six hormones at issue."  
7.786  We also note Dr. Guttenplan's comment that: 
"There is more limited evidence available for Trenbolone and Zera nol and most of it 
is in vitro  (SCVPH 2002 Opinion ) or not recent (e.g., JECFA meeting 34
th report, 
1989 and 32nd report, 1988).  However, both appear to be potentially significantly 
estrogenic.  Experimental and analytic al methods have improved but it does not 
appear that accurate ADI's can be established at this point.  Studies in experimental 
animals and studies on levels in beef ar e still needed.  However, from the data 
available at the time of the Directive, th e potential for adverse effects could not be 
ruled out."880  
7.787  We note, however, that during our meeting with the experts, Dr. Guttenplan clarified, at the 
EC request, that "the ability [to make a risk assess ment] varies between compounds, but that does not 
mean that you can't make a risk assessment, it just means that the accuracy of the risk assessment is 
different."881  Regarding the establishment of accurate ADI s, Dr. Guttenplan clarified that "accurate 
means – if it's not accurate, there is just a la rger range, but you can still do a risk assessment."882  
7.788  These general remarks support our conclusions on the specific elements discussed above.  We 
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with 
respect to zeranol, within the meaning of Article 5.7 of the SPS Agreement . 
(xi) Is relevant scientific evidence insufficient in  the case of melengestrol acetate (MGA)? 
Summary of the main arguments of the parties883 
7.789  Canada  argues that melengestrol acetate is the mo st recent hormone to be evaluated by 
JECFA. This hormone was evaluated by JECFA at its fifty-fourth meeting in 2000. In 2004, JECFA further evaluated its recommendations for melengestro l acetate in the light of the new data contained 
                                                     
 
880 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 457. 
881 Transcript of the Panel meeting with the experts, Annex G, para. 983. 
882 Transcript of the Panel meeting with the experts, Annex G, para. 985. 
883 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel.  WT/DS321/R 
 Page 293 
 
 
  in three residue monographs prepared in advance of its sixty-second meeting. In the Report of this 
meeting, JECFA recommended an ADI for melengestrol acetate.884 
7.790  Canada adds that JECFA has noted that mele ngestrol acetate does not contain a structural 
alert for mutagenicity and genotoxicity and found th at in a series of mutagenicity and genotoxicity 
tests the results were negative.885 
7.791  Canada is of the view that, based on the scien tific data contained in these JECFA reports and 
the recommended ADIs for these subs tances, JECFA does not consider that residues of these 
hormones have an adverse effect on human health , provided they are used in accordance with good 
veterinary practices. Canada concludes that, faced  with this conclusion fro m JECFA, the European 
Communities cannot substantiate its assertion that there is insufficient scientific information to 
perform an adequate risk assessment in respect of these five hormones.886 
7.792  The European Communities , quoting passages the 1999 Opinio n, identified the following 
insufficiencies in the evidence:887 
(a) only limited data are available concerning MGA residues in treated cattle;   
(b) no information is available on mu tagenicity and genotoxicity; 
(c) no information is available on DNA adducts and DNA damage; 
(d) carcinogenicity studies have been conducte d in only one animal species, which is 
inadequate to assess the carcinogeni c potential of melengestrol acetate;888   
(e) available data on effects of melengestrol acetate on growth and reproduction do not 
allow an estimate of the dose-response relationship;   
(f) data on the effect of melengestrol acetate on the immune system are also very limited.   
7.793  The European Communities adds that the SCVPH concluded that the available information is 
insufficient for a quantitative estimate of the risk to the consumer of meat from treated animals.  The 
European Communities indicates that in its 200 2 Opinion, the SCVPH found these conclusions 
compounded by data obtained in certain of the 17 studies. 
7.794  The European Communities recalls the finding of the Appellate Body in EC – Hormones  that 
no risk assessment had been performed and notes that Codex has not adopted an international standard 
on melengestrol acetate, although JECFA assessed  melengestrol acetate in 2000 (and in 2004 as 
regards calculation of the MRL).   The European Communities argues that in  the absence of a Codex 
standard, the opinion of JECFA becomes irrelevant.  In addition, the European Communities indicates 
that JECFA failed to take into account the more recent data generated by its 17 studies and the 2002 
Opinion.889 
                                                      
884 Canada's first written submission, paras. 116-124. 
885 Canada's second written submission, para. 135. 
886 Canada's first written submission, paras. 116-124. 
887 EC's second written submission, paras. 161-166. 
888 In its conclusion on carcinogenicity, the SCVPH notes that in view of the lack of data on 
mutagenicity/carcinogenicity and on DNA interaction, and in consideration of carcinogenicity studies conducted only in one animal species, the data are inadequate to assess the carcinogenetic potential of MGA. 
889 EC's second written submission, para.161. WT/DS321/R 
Page 294 
 
 
  7.795  The European Communities notes that the SC VPH took into account the JECFA assessment 
and noted that no original data had been presente d in the JECFA report and that the majority of 
references were to reports that had not been pub lished in the peer-reviewed scientific literature.890  
7.796  The European Communities refers to a draft 2005 report from the UK Committee on 
Veterinary Practices.  According to the Europ ean Communities, this report notes that there are 
important gaps in the evidence base for oestradiol-17 β and the other five hormonally-active 
substances, as acknowledged in the Opinion.  Th e cited passage then states a need for certain 
information, including a number of  issues where more information is needed to improve future risk 
assessments.891   
7.797  The European Communities concludes that ther e is no doubt that the 1999-2002 Opinions 
constitute the only currently available risk assessme nt on melengestrol acetate, based on the most 
recent, peer-reviewed, pertinent information ava ilable publicly from the European Communities.  The 
European Communities notes that these Opinions reached the conclu sion that the current state of 
scientific knowledge does not permit a more definitive risk assessment to be carried out.892 
Reasoning of the Panel  
7.798  In light of the arguments of the parties and of  the fact that some of the insufficiencies 
identified by the European Comm unities have been addressed in th e common section above, or were 
simply not discussed by the European Communities in  its submissions, the Panel will limit its analysis 
to determining whether relevant scientific evid ence is insufficient concerning melengestrol acetate 
with regard to the following aspects: 
(a) only limited data are available concerning MGA residues in treated cattle;  
(b) inadequate evidence for carcinogenicity in humans, such as no information available 
on mutagenicity and genotoxicity and no  information available on DNA adducts and 
DNA damage. 893 
7.799  As a preliminary remark, the Panel notes that C odex did not adopt any standard with respect 
to melengestrol acetate.  The Panel recalls, however, that while there is no international standard as 
such, intensive work has been pe rformed at the international level. JECFA made two assessments of 
melengestrol acetate in 2000 and 2004 (the second time in order to propose a MRL).  It was included 
in the priority list for recalculation of MRLs and TMDI by the fifteenth session of CCRVDF that met 
in 2005.894 The Panel notes in this respect that for mele ngestrol acetate, the draft MRL is currently at 
Step 7 of the Codex elaboration procedure.895  Moreover, the role of JECFA in the international risk 
assessment process is such th at some degree of relevance should be given to that work. The Panel also 
notes that at no time did the European Communities request that melengestrol acetate be considered 
by Codex.896  
                                                      
890 EC's second written submission, para.164; EC's replies to Panel questions after the first substantive 
meeting, question 22, Annex B-1, paras. 126-127.   
891 EC's second written submission, para.165. 
892 EC's second written submission, para.166. 
893 EC's second written submission, para. 162, quoting 1999 Opinion, p. 77. 
894 Dr. Miyagishima, Codex representative, transcript of the Panel meeting with the experts, Annex G, 
para. 524. 
895 As explained by Dr. Miyagishima, Codex representative.  See transcript of the Panel meeting with 
the experts, Annex G, para.896. 
896 Dr. Miyagishima, transcript of the Panel meeting with the experts, Annex G, para. 524.  WT/DS321/R 
 Page 295 
 
 
  Data on residues of melengestrol acetate 
7.800  The two main criticisms of the European Co mmunities regarding JECFA' s assessments are 
that the residue data used by JECFA on MGA are outdated and that JECFA did not take into account 
the more recent studies commissioned by the Eu ropean Communities. In the 2002 Opinion, the 
SCVPH noted that in the JECFA report no original data had been presented and that the majority of 
references were to reports that had not been pub lished in the peer-reviewed scientific literature.897  
7.801  We sought the views of the experts on this matter and two of them gave an opinion 
(Dr. Boisseau, Dr. De Brabander).  Both concurre d in saying that nearly all the studies used by 
JECFA dated back to the 1960s and 1970s.  However,  neither of the two experts stated that these 
studies were no longer valid.898 
7.802  The Panel first recalls its position on so -called "old" data in paragraph 7.414 et seq . above. 
7.803  Second, the Panel notes the opinion of Dr. Boisseau: "It is correct to say that nearly all the 
studies referred to in the 2000 JECFA report on melengestrol acetate date from the 1960s and 1970s.  The comment  to be made on this issue is [that]  JECFA considered a wide series of toxicological 
studies in its assessment, used as an end point a n on hormonal effect dose by far more conservative 
than a NOAEL based on tumorigenic effect and adopt ed a 200 safety factor to derive an ADI from 
this NOAEL."
899   
7.804  Dr. Boobis also expressed his views on the more recent studies commissioned by the 
European Communities.  With r espect to the findings of study 4 referred to by the European 
Communities regarding residues of melengestrol acetate, Dr. Boobis mentioned the following:  
"In study 4, unpublished preliminary findi ngs on the in vitro metabolism of MGA 
were reported.  This study provided some  evidence for the formation of multiple 
metabolites of MGA by liver from human, rat and bovine.  However, these findings do not affect the risk assessment of MGA because a) the toxicological studies were 
conducted in animals that would have been  exposed to all of the metabolites of 
concern, b) JECFA assumed that all of the residues in meat from animals treated with 
MGA were as hormonally active as MGA when it proposed MRLs in 2002 (JECFA, 
2002b) .  It was subsequently shown that this was a conservative decision, as not all of 
the residues were as active as MGA itself (JECFA, 2006c)."
900 
7.805  Although the European Communities criticized Dr. Boobis' analysis of some of the 17 studies 
in its comments on the replies of the experts901, it did not specifically address Dr. Boobis' comments 
on study 4. 
                                                      
897 2002 Opinion, p. 16. 
898 Reply of Dr. De Brabander to question 35 of the Panel, Annex D, paras. 304-305. 
899 Reply of Dr. Boisseau to question 35, Annex D, para. 303. 
900 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 484.  Dr. Boobis cites to: 
 – JECFA (2002b). Residues of some veterinary drugs in animals and foods. FAO Food 
and Nutrition Paper 41/14, Rome, Italy; and 
 
– JECFA (2006c). Residues of some veterinary drugs in animals and foods. FAO, Rome, Italy 
(in press). 
901 EC's comments on the replies of the experts, Annex F-1, p. 40. WT/DS321/R 
Page 296 
 
 
  Inadequate evidence for carcinogenicity in humans, such as no information available 
on mutagenicity and genotoxicity and no information available on DNA adducts and 
DNA damage 
7.806  We note that the 2002 Opinion mentions that  the genotoxicity of melengestrol acetate was 
investigated (study 4) and that "[t]he resu lts were negative in several experiments using 
concentrations in either 15-125 uM for HPRT muta tions, 20-100 uM for micronuclei induction, and 
400uM for LacI mutations."902 
7.807  This statement seems to confirm JECFA's conclusions, as recalled by Dr. Boisseau:  
"[I]n its fifty fourth session, JECFA concluded from the review of a range of assays 
in vitro and in vivo that melengestrol acetat e is not genotoxic. It also agreed upon the 
fact that  'no firm conclusion could be drawn about the carcinogenic potential of melengestrol acetate in ICR mice … the increased incidence of malignant tumors in 
the highest-dose group of prepubertal C3Han/f mice was assumed to be due not to a 
direct carcinogenic effect of melengestrol acetate but to the promoting effect of increased prolactin concentrations'."
903 
7.808  Dr. Boisseau's comment is confirmed by Dr. Boobis, referring inter alia  to study 4 of the 
17 studies commissioned by the European Communities: 
"There is no convincing evidence that trenbolone acetate, MGA and zeranol are 
genotoxic.  They were negative in a range of tests for genotoxicity.  They were very 
weakly positive in a micronucleus test, at high (potentially cytotoxic) concentrations.  
Trenbolone also produced a low level of DNA adducts measured by 32P-post-
labelling (Metzler and Pfeiffer, 2001) .904  As indicated above, micronuclei can arise 
via a non-genotoxic mechanism, particularly at concentrations that may have caused 
some toxicity.  In addition, the 32P-post-la belling assay is not specific, and data cited 
above suggest that DNA adduction can arise by mechanisms other than direct 
interaction with DNA.  In no case did a ny of the compounds produce a mutagenic 
response.  These data are insufficient to support the conclusion that these hormones 
have genotoxic potential in vivo.  Thus, th ere is no evidence that any of the hormones 
are genotoxic in vivo at the levels found in meat from treated animals.  Even if GVP 
were not followed, the levels of exposur e to the hormones would be such that no 
genotoxicity would be anticipated in vivo." 
7.809  Dr. Guttenplan also agreed that: 
"[T]here is no conclusive evidence presente d by the EC that the five hormones other 
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.  
There is some evidence that certain of the hormones have genotoxic potential, but 
generally the potential is weak. ... MGA is  negative in genotoxicity assays. Any 
                                                      
902 2002 Opinion, section 4.5.3, p. 18. The general co nclusions, states that "[ d]ata on the genotoxicity 
of melengestrol acetate indicate  only weak effects", p. 22. 
903 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 161. 
904 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth 
promoters and their metabolites.  APMIS, 109:89-95.  See  Annex D, para. 198.  WT/DS321/R 
 Page 297 
 
 
  genotoxic effects of the five hormones are lik ely to be minimized by good veterinary 
practice."905 
7.810  We note that the European Communities argues that new studies have brought fresh evidence 
which depart from the majority view.  At our request, the experts commented on the 17 studies commissioned by the European Communities.  Rega rding study 4, which is referred to in the 2002 
Opinion, Dr. Boobis confirmed the negative results  concerning mutagenicity  and genotoxicity of 
melengestrol acetate: 
"[I]n study 4 (mutagenicity and genotoxicity of MGA), MGA was negative in studies 
of the induction of hprt mutations in V79 cells, the induction of micronuclei in V79 
cells and the induction of lacI mutations in E coli . Pure MGA had no effect on 
apoptosis, which could potentially conf ound interpretation of studies using V79 
cells."
906  
7.811  Dr. Boobis adds, with respect to DNA adducts, that: 
"[P]reliminary studies with rat liver slices, reported in an abstract but not yet 
published in the peer reviewed literatu re, suggested that MGA could produce 
unidentified adducts with DNA.  As indicat ed above, there are mechanisms of adduct 
formation that do not involve direct inte raction of the inducing compound with DNA.  
Overall, a report of putative covalent  binding to DNA observed using 32P-post-
labelling is not sufficient to over-ride the consistently negative results of MGA in a 
range of tests for mutagenicity.  Hence, on the basis of the findings in study 5, there is no reasons to change the risk assessment or MGA."
907 
7.812  Regarding carcinogenicity of melengestrol acetat e, we note that melengestrol acetate has not 
been evaluated by IARC, nor have the specific risks from the consumption of meat from cattle treated with this growth promotion hormone.
908  In reply to a question from the Panel on whether the 
carcinogenic effects of the hormones at issue were  related to a mechanism other than hormonal 
activity, Dr. Boisseau replied that:  
"[i]n its 1999 report, SCVPH concluded, a bout the carcinogenicity of melengestrol, 
that: 'in view of the lack of data on mutagenicity/carcinogenicity and on DNA 
interactions and in consideration of ca rcinogenicity studies conducted only in one 
animal species, these data are inadequate  to assess the carcinogenic potential of 
melengestrol.' Therefore,   the scientific evidence relied upon in the SCVPH Opinions 
does not support the conclusion that the carcinogenic effects of melengestrol are 
related to a mechanism other than hormonal activity."909 
7.813  The European Communities cont ests these comments, arguing th at Dr. Boisseau interprets 
lack of data as lack of adverse effect.910  We do not agree with the European Communities.  The test 
to be met under Article 5.7 is that relevant scientific  evidence be insufficient, and we have considered 
that, in this case, this implied that there be a cr itical mass of new evidence and/or information that 
calls into question the fundamental precepts of previous knowledge and evidence so as to make 
                                                      
905 Reply of Dr. Guttenplan to question 21 of the Pane l, Annex D, para. 200. Dr. Guttenplan, referring 
to the 2002 Opinion, mentioned that his reply for the hormones would not have been different in September 
2003. 
906 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 486. 
907 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 486. 
908 IARC reply to question 25 of the Panel, Annex E-3, p. 129. 
909 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 162. 
910 EC's comments on the experts replies, question 16, Annex F-1, p. 13. WT/DS321/R 
Page 298 
 
 
  relevant, previously sufficient, evidence now insufficient.  This is also the case for melengestrol 
acetate.  We recall that JECFA evaluated this horm one on two occasions.  This suggests that evidence 
has been at one point sufficient.  Having regard to  this context, we do not read the EC comment, nor 
any evidence presented in the course of these pro ceedings, as meeting the above-mentioned test. 
Conclusion  
7.814  Having regard to our specific conclusions above, we recall that the Appellate Body clarified 
in Japan – Apples  that relevant scientific evidence will be insufficient within the meaning of 
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative 
terms, the performance of an adequate assessment of  risks as required under Article 5.1.  In this 
respect, we note that, at our request, the experts also expressed their views on the more general question whether the scientific evidence available at  the time of the adoption of Directive 2003/74/EC 
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated, 
inter alia,  with melengestrol acetate.  Dr. Boobis replied that: 
"[T]here was sufficient information availabl e to the EC to have enabled it to have 
conducted an assessment of the risks to human  health arising from consumption of 
meat from cattle treated with any of the six hormones at issue."  
7.815  We also note Dr. Guttenplan's comment with  respect to JECFA's risk assessment that: 
"The assessment for melengestrol acetate seems sound.  Thorough metabolic and 
estrogenic studies have been carried out."
911 
7.816  These general remarks support our conclusions on the specific elements discussed above.  We 
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with 
respect to melengestrol acetate, within  the meaning of Article 5.7 of the SPS Agreement . 
(xii) Conclusion 
7.817  We recall that we asked the scientific expert s whether the scientific evidence relied upon by 
the European Communities supports th e EC contention that the new scientific studies that have been 
initiated since 1997 have identified new important gaps, insufficiencies and contradictions in the 
scientific information and knowledge now availabl e on these hormones such that more scientific 
studies are necessary before the risk to human he alth from the consumption of meat from cattle 
treated with these hormones for growth  promotion purposes can be assessed.912 
7.818  Three experts replied.  In his written reply, Dr. Guttenplan saw several important gaps and 
gave examples.  However, at the meeting with the Panel, he specified that, "on subsequent reading, 
[he] could not find anything to indicate adverse e ffect, and [he] now think[s] that risk assessment is 
alright."913 He added that "the ability [to make a risk  assessment] varies between compounds, but that 
does not mean you can't make a risk assessment, it just means the accuracy of  the risk assessment is 
different."914  The other two experts considered that "these new data [provided by the European 
Communities] [did] not demonstrate any important ga ps, insufficiencies or contradictions in the 
scientific information used by JECFA for c onducting its risk assessments" (Dr. Boisseau)915, or that 
"[t]here was little information in the scientific studies initiated by the EC since 1997 that support the 
                                                      
911 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 458. 
912 Panel question 62. 
913 Transcript of the Panel meeting with the experts, Annex G, para. 981. 
914 Transcript of the Panel meeting with the experts, Annex G, para. 983. 
915 Reply of Dr. Boisseau to question 62 of the Panel, Annex D, para. 460.  WT/DS321/R 
 Page 299 
 
 
  contention that they have identified important ne w gaps, insufficiencies and contradictions in the 
scientific information and knowledge on the horm ones, and that additional studies are necessary 
before the risks to health of consumption of meat from treated animals can be assessed" 
(Dr. Boobis).916 Dr. Boobis elaborated as follows: 
"Whilst additional information has been obtained on a number of aspects of the 
hormones in question, this was often not de finitive, sometimes it was not relevant, in 
some instances it confirmed or expanded on previous knowledge.  The evidence 
obtained did not indicate any additional concern regarding the risk from exposure to 
residues of the hormones in meat from cattle treated for growth promotion."   
7.819  We also note that, at our meeting with expert s, Dr. Cogliano and Dr. Boobis confirmed, in 
response to a question from the Panel, that the data  were sufficient to perform a risk assessment based 
on ADI, as done by JECFA.917  
7.820  We recall that the test we applied in this case was that there must be a critical mass of new 
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge 
and evidence so as to make relevant, previously su fficient evidence now insufficient. We note that the 
experts who expressed themselves in detail on this ma tter have confirmed, both in general and for 
each of the five hormones subject to a provisional ba n, that such critical mass had not been reached. 
7.821  For all these reasons, we conclude that it has not  been demonstrated that relevant scientific 
evidence was 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. 
7.822  We recall that all four of the requireme nts identified by the Appellate Body in Japan – 
Agricultural Products  II with regard to the application of Article 5.7 of the SPS Agreement  must be 
satisfied in order to adopt and ma intain a provisional measure. The A ppellate Body noted that the four 
requirements are "clearly cumulative in nature".  Since we found that the first requirement (the 
measure is imposed in respect to a situation wher e "relevant scientific evid ence is insufficient") has 
not been satisfied, we do not find it necessary to address any of the three other requirements.  We therefore conclude that the EC compliance measure does not meet the requirements 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. 
7.823  Having reached that conclusion, we want to make  clear that we only determined that it had 
not been established that the existing relevant sci entific evidence was insuffi cient.  This does not 
mean that no measure can be imposed by the European Communities under the SPS Agreement  in 
relation to the five hormones at issue.  Indeed, our  determinations are without prejudice to the legality 
of any EC measure regarding these hormones, shoul d the European Communities decide to complete 
its risk assessments pursuant to Article 5.1 of the SPS Agreement .  
                                                     
 
916 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 495. 
917 Transcript of the Panel meeting with the experts, Annex G, Dr. Cogliano, para. 871; Dr.  Boobis, 
para. 873. WT/DS321/R 
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  (g) Compatibility of the EC implementing measure with Article 3.3 of the SPS Agreement  with 
respect to all hormones with the exception of melengestrol acetate 
Summary of the main arguments of the parties918 
7.824  Canada  argues that WTO Members are allowed under Article 3.3 of the SPS Agreement  to 
maintain SPS measures that result in a higher level of  protection than that which would otherwise be 
achieved through measures that are based on internationa l standards only if certain conditions are met.  
7.825  Canada notes that the European Communities permanent ban on oestradiol-17 β and its 
provisional ban on the other five hormones result in a level of protection that is higher than that 
implied in international standards.  On the b asis of conclusions by JECFA that the presence of 
hormone residues in meat from treated animals do es not present a health concern, Codex established 
MRLs for trenbolone acetate and zeranol, and d ecided that none was necessary for oestradiol-17 β, 
testosterone and progesterone. 
7.826  Therefore, not only must the European Commun ities demonstrate, pursuant to Article 5.1 of 
the SPS Agreement , that its measure is "based on" a risk assessment, but the risk assessment on which 
the EC measure is based must also demonstr ate that existing international standards ( i.e. the ADI and 
MRLs established by JECFA and Codex) are not ca pable of achieving "zero additional risk" – the 
appropriate level of protection that  the European Communities has set fo r itself. Canada considers that 
The European Communities failed to  identify any "additional risks" that would arise from ingestion of 
residues of the six hormones at levels that comply w ith international standards. As a result of this 
failure, the EC measure is also inc onsistent with Article 3.3 of the SPS Agreement.919 
7.827  The European Communities  argues that it decided not to use the Codex standard on 
oestradiol-17 β, because the Codex recommendations are not only old but also do not allow the 
European Communities to achieve the level of prot ection it considers appropriate in its territory.920 
7.828  With respect to the other five hormones, th e European Communities considers that it is 
possible, in the presence of an international sta ndard, guideline or recommenda tion that is based on a 
risk assessment, to adopt a provisional sanitary measu re on the grounds that the relevant scientific 
evidence is insufficient.  A Member may disagree w ith the risk assessment for scientific reasons and, 
in particular, on the issue of whether the scien tific evidence relied upon is sufficient.  Such 
disagreement may stem from differences of views on scientific questions such as methodology, data 
interpretation etc.  It may also result from the fact that in order to meet a higher level of protection, 
the Member concerned may require more information than what is provided in the risk assessment in 
question. As a concrete example, the JECFA study  referred to by the defending parties did not take 
into account the data obtained in the seventeen studies which had been performed upon the initiative 
and with the funding of the European Communities.921 
                                                      
918 A more detailed account of the parties' arguments can  be found in Section IV of the descriptive part 
of this Report.  The order in which the respective argu ments of the parties are presented does not reflect any 
allocation of the burden of proof by the Panel. 
919 Canada's second written submission, paras. 51-54. 
920 EC's replies to Panel questions after the firs t substantive meeting, question 22, Annex B-1, 
para. 129,;  EC's second written submission, para. 101; EC's oral statement at the second panel meeting (20 October 2006), para. 19. 
921 EC's replies to Panel questions after the first substantive meeting, question 72, Annex B-1.  WT/DS321/R 
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  Reasoning of the Panel  
7.829  Article 3.3 of the SPS Agreement  reads as follows: 
"Members may introduce or maintain sanitary ... measures which result in a higher 
level of sanitary ... protection than wo uld be achieved by measures based on the 
relevant international standards, guid elines or recommendations, if there is a 
scientific justification, or as a consequen ce of the level of sanitary ... protection a 
Member determines to be appropriate in acco rdance with the relevant provisions of 
paragraphs 1 through 8 of Article 5.922  Notwithstanding the above, all measures 
which result in a level of sanitary ... protection different from that which would be achieved by measures based on international standards, guidelines or 
recommendations shall not be inconsiste nt with any other provision of this 
agreement." 
7.830  We concluded above that the European Comm unities did not comply with Article 5.1 and 
with Article 5.7 of the SPS Agreement .  In light of our mandate and of our objectives in engaging in a 
review of the conformity of the EC 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. 
7.831  We therefore refrain from drawing any conclu sion with respect to Article 3.3 of the 
SPS Agreement .   
(h) Conclusion on Article 22.8 of the DSU 
7.832  For the reasons stated above, we conclude that it has not been established that the European 
Communities has removed the measure found to be  inconsistent with a covered agreement. 
7.833  We also note that the European Communities does not claim that it has provided a solution to 
the nullification or impairment of benefits suffered by Canada within the meaning of Article 22.8 of 
the DSU. 
7.834  None of the parties has claimed that a mutua lly satisfactory solution had been found in the 
context of the EC – Hormones  case. 
7.835  For these reasons and those deve loped above, we find that the European Communities did not 
demonstrate a breach of Article 22.8 of the DSU by Canada. 
4. Violation of Articles 23.1 and 3.7 of the DSU 
7.836  The Panel recalls its understanding that violations  of Articles 23.1 and 3.7 were only claimed 
in relation to the violation of Article 22.8 of the DS U.  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 Canada 
as a result of a breach of Article 22.8. 
                                                     
 
922 (footnote original ) For the purpose of paragraph 3 of Article 3,  there is a scientific justification if, on 
the basis of an examination and evaluation of available sc ientific information in conformity with the relevant 
provisions of this agreement, a Memb er determines that the relevant international standards, guidelines or 
recommendations are not sufficient to achieve its  appropriate level of sanitary ... protection. WT/DS321/R 
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  D. VIOLATION OF ARTICLE   I:1 AND ARTICLE  II OF THE GATT  1994   
7.837  The European Communities has claimed that there is a violation of Articles I:1 and II of the 
GATT 1994 because Canada's continued suspension of obligations could not be justified anymore 
under Article 22 of the DSU. 
7.838  In light of our conclusions above, we see no basi s to make findings in relation to these claims.  
E. CONDITIONAL CLAIM OF VIOLATION OF ARTICLE  22.8  OF THE DSU  MADE IN THE 
ALTERNATIVE  
7.839  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".923 
7.840  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 Ar ticle 22.8 of the DSU as part of our review of 
the EC claim of violation of Article 23.1 read togeth er with Article 22.8 and Article 3.7 of the DSU.  
Under those circumstances, it is not necessary fo r the Panel to address the conditional claim of 
violation 22.8 of the DSU per se  in the alternative.  
F. CONCLUSION  
7.841  For the reasons set forth in this report, the Pane l concludes that, with respect to the claims of 
the European Communities concerning the violati on of Article 23.2(a) read together with 
Articles 21.5 and 23.1 of the DSU, Canada 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 notif ication of the EC implementing measure 
(Directive 2003/74/EC) – the redress of a violation of obligations under a covered 
agreement without having recourse to, and ab iding by, the rules and procedures of the 
DSU, Canada has breached Article 23.1 of the DSU; 
(b) by making a determination within the meani ng 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, Canada has breached 
Article 23.2(a) of the DSU. 
7.842  In addition, having addressed the claims raised  by the European Communities concerning the 
violation of Article 23.1 read together with Articles 22.8 and 3.7 of the DSU based on the considerations mentioned above
924, the Panel concludes that, 
(a) to the extent that the measure found to be inconsistent with the SPS Agreement  in the 
EC – Hormones  dispute (WT/DS48) has not been removed by the European 
Communities, Canada has not breached Article 22.8 of the DSU; 
(b) to the extent that Article 22.8 has not been breached, the Eur opean 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 . 
                                                      
923 EC's first written submission, para. 133. 
924 See Section VII.C.2 and Section VII.C.3(a), (b) and (c) above.  WT/DS321/R 
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  VIII.  RECOMMENDATIONS 
8.1 Article 3.8 of the DSU provides that "[i]n cases where there is an infringement of the 
obligations assumed under a covered agreement, the ac tion is considered prima facie to constitute a 
case of nullification or impairment".  Canada failed to rebut this presump tion.  Therefore, to the extent 
Canada has acted inconsistently with its obliga tions under the DSU, it must be presumed to have 
nullified or impaired benefits accruing to th e European Communities under that Agreement. 
8.2 In the light of these conclusions, the Panel recommends that the Dispute Settlement Body 
request Canada to bring its measure into c onformity with its obligations under the DSU. 
8.3 Whereas it is for the  Members to decide on the appropriate  steps needed to bring measures 
found in breach of their WTO obligations into conf ormity, the Panel deems it important to recall its 
conclusion in paragraph 7.244 above as the parties have  apparently diverging opinions as to how this 
report should be implemented by th e 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 determine whether 
Article 22.8 of the DSU had been br eached. This Panel was not called upon,  nor does it have 
jurisdiction, to determine the compatibility of Di rective 2003/74/EC with th e 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 disput e, Canada should have recourse to the rules and 
procedures of the DSU without delay. 
 
__________