WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 692 
  
  (d) Overall conclusion  
7.1627  In the light of the above, the Panel reaches the following conclusion:  
 (i) DS293 (Argentina) 
 
  With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the European Commun ities has acted inconsistently with its 
obligations under Article 10.1 of the SPS Agreement  by applying a general de facto  
moratorium on approvals between  June 1999 and August 2003. 
 E. 
PRODUCT -SPECIFIC MEASURES  
1. Measures at issue 
7.1628  In addition to the general de facto  moratorium on approvals, the Complaining Parties are also 
challenging a number of product-specific measures.  Th e Panel begins its analysis by setting out the 
Complaining Parties' general descriptions of the measures at issue and the European Communities' 
comments in response. 
(a) General 
7.1629  The United States  notes that it is challenging the failure  by the Commission and the member 
States to consider for approval certain applications specified in its request for the establishment of a 
panel.  The United States refers to these product- specific measures as "produc t-specific moratoria".  
According to the United States, these product-spec ific moratoria are separate measures from the 
general moratorium affecting all applications.  The United States also notes, however, that they are similar measures in that both refer to the European  Communities' failure to consider applications for 
approval.  Also, since the general moratorium applie d to all applications, a necessary corollary is that 
the European Communities also adopted produc t-specific moratoria on each of the relevant 
applications specified in the United States' panel request.  Accordingly, the evidence and arguments 
the United States adduced in support of the existe nce of a general moratorium also establish the 
existence of the product-specific moratoria, and th at the European Communities did not undertake and 
complete its approval procedures for each indivi dual application without undue delay.    
7.1630  Canada  states that it is challenging the failure by the European Communities to consider or 
approve, without undue delay, certain applications specified in its request for the establishment of a 
panel.  Canada refers to the failure by the European Communities in this regard as the product-
specific marketing bans.  Canada contends that the general moratorium and the product-specific 
marketing bans are closely related, though distinct , measures.  The product-specific marketing bans 
are a direct consequence of the moratorium as ap plied to individual applications.  They are the 
manifestation of the moratorium in the context of the approval procedures of the four specific 
products of concern to Canada.  Ca nada's arguments in relation to product-specific marketing bans are 
intended to focus on the direct and detrimental imp act of the moratorium on specific applications.  
7.1631  Argentina  states that it is challenging (i) the su spension by the European Communities of 
consideration of specified applications for approval, or the failure to consider specified applications 
for approval as well as (ii) the undue delays in  completing the consideration and processing of 
specified applications.  Argentina argues that the product-specific suspension of processing or failure  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 693 
  
  to consider as well as the undue delay ar e effects of the application of the de facto  moratorium to 
specific applications for approval.    
7.1632  The European Communities  notes that it has considerable difficulty in understanding the 
difference between the first group of claims by the Complaining Parties relating to the alleged 
moratorium on approvals and the second group of clai ms relating to alleged failures to consider for 
approval specific applications.  According to th e European Communities, the Complaining Parties' 
assertions about a "suspension of procedures" or any "failure to consider applications" are assertions 
about delay.   
7.1633  The Panel  notes that, according to the Complaining Parties, the product-specific measures 
they are challenging are distinct from the general de facto  moratorium on approvals.  At the same time 
all three Complaining Parties point out that the pr oduct-specific measures are related to the general 
moratorium on approvals.  Based on these statements and the Complaining Parties' arguments, it is our understanding that the product-specific measures are, or arise from: 
− specified acts and/or omissions through wh ich the relevant EC entities were giving 
effect, in the context of particular approva l procedures, to their decisions to impose a 
general moratorium on approvals, or 
− specified acts and/or omissions through whic h relevant EC entities chose to respond, 
again in the context of particular approval procedures, to the circumstance that other 
EC entities were imposing a gene ral moratorium on approvals. 
 7.1634  It should be noted, however, that in their requests for the establishment of a panel, the 
Complaining Parties have described the product-speci fic measures in more general terms.  Moreover, 
each Complaining Party has used a so mewhat different description.  It is therefore useful to address 
these different descriptions one by one.   
7.1635  The United States in its panel request says that the measure at issue is the failure by the 
European Communities to consider particular applica tions for approval.  It is clear to us that the 
United States does not contend that the European  Communities has not considered the relevant 
applications at all.  In our view, the United Stat es contends that the European Communities has failed 
to consider the relevant applications for final approval.  We understand this to be essentially a 
contention that the consideration of these applicati ons was affected by the general moratorium on 
final approvals, in the sense that their consideration was either effectively suspended at some point in 
the approval process or continued at a delayed p ace.  This understanding would appear to be 
supported by the fact that when referring to the pr oduct-specific measures, the United States speaks of 
the "product-specific moratoria".   
7.1636  Canada in its panel request says that the measu re at issue is the failure by the European 
Communities to consider or approve, without undue delay, the applica tions mentioned in its request.  
Thus, unlike the United States, Canada explicitly includes an allegation of undue delays in the 
consideration and approval of th e relevant applications in the definition of the measures being 
challenged.  At the same time, Canada refers to the alleged failure to consider  or approve the relevant 
applications without undue delay as the product-sp ecific marketing bans.  Canada claims in this 
regard that at some point in the approval process each of the relevant applications was subjected by 
the European Communities to an effective marketing ban.  The validity of this claim will be discussed 
further below.  At this stage, it is sufficient to  note that we will conduct our examination based on the 
description of the product-specific measures set out in Canada's panel request.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 694 
  
  7.1637  Argentina distinguishes two types of product-specific measures.  The first type of product-
specific measure is described in Argentina's panel re quest as the suspension of consideration of, or the 
failure to consider, particular app lications for approval.  In our unde rstanding, this type of measure is 
conceptually the same as the product-specific measur es referred to in the United States' panel request.  
The second type of product-specific measure identif ied in Argentina's panel request concerns undue 
delays in finalizing consideration of particular a pplications for approval.  Accordingly, like Canada, 
Argentina explicitly includes an allegation of undue  delays in the consideration of the relevant 
applications in the definition of the measures being challenged.   
(b) Relevant applications 
7.1638  As noted above, each of the product-speci fic measures challenged by a particular 
Complaining Party relates to a particular application.   Below it is indicated (i) how many applications 
were specified by each Complaining Party and (ii) on how many of these applications the Panel has 
been requested to offer product-specific findings.  
(i) DS291 (United States) 
7.1639  The United States in its request for the establis hment of a panel stated that the relevant 
applications are mentioned in Annexes I and II to its  request.  These two Annexes list a total of forty-
one applications.  As all forty-one applications are within the terms of reference of this Panel, there 
are, in principle, forty-one product-specific measur es which the United States could seek to challenge.  
However, in its first written submission, the United St ates indicated that it is making claims in respect 
of only twenty-seven applications.
1336  We conclude from this that the United States has abandoned its 
product-specific claims in respect of the remaining fourteen applications.1337   
7.1640  According to the United States' first written su bmission, the twenty-seven applications in 
respect of which it is pursuing product-specific cl aims include eighteen which were submitted under 
Directive 90/220 and were pending under Directive 2001/18  on the date of estab lishment of this Panel 
as well as nine applications pending under Regulation 258/97.1338  Among the nine applications the 
United States claims were pending under Regulati on 258/97, there are two applications which were 
withdrawn before the Panel was established.  They  are Transgenic red-hearted chicory (food) and 
Transgenic green-hearted chicory (food).  Evid ence provided by the European Communities shows 
that both were withdrawn by the applicant in May 2003.1339  We note in this respect that, in a 
submission made subsequent to its  first written submission, the United States stated that it is not 
requesting findings on applications that were w ithdrawn prior to the establishment of the Panel.1340  In 
the light of this categorical statement, we consid er we need not, and hence do not, make findings in 
respect of the two aforementioned a pplications concerning transgenic chicory.  This means that there 
are in total twenty-five applications on which the Pa nel is expected to offer product-specific findings 
                                                      
1336 US first written submission, paras. 67, 131, 137-138. 
1337 It should be noted that the United States discussed the applications concerning MS1/RF2 oilseed 
rape and MS1/RF1 oilseed rape (EC-89) under the head ing "product-specific moratoria".  US second written 
submission, para. 53.  However, the United States also presented arguments relating to its general moratorium claim under that heading.  US second written submission, paras. 52-53.  Accordingly, we  do not understand the 
United States to have increased the numb er of measures in respect of which it is making product-specific claims.    
1338 The eighteen applications pending under Directive 2001/18 are identified at paras. 49-51 of the US 
first written submission; the nine applications pending und er Regulation 258/97 are iden tified at paras. 54-55 of 
the US first written submission.   
1339 Exhibits EC-97/At. 32 and EC-98/At. 42.  The Un ited States also acknowle dges this fact.  US 
second written submission, footnote 76. 
1340 US reply to Panel question No. 197, footnote 26.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 695 
  
  – eighteen which were pending under Direc tive 2001/18 and seven which were pending under 
Regulation 258/97.   
7.1641  The eighteen applications which were pendi ng under Directive 2001/18 as of August 2003 
comprise those concerning: 
− Bt-531 cotton 
− RR-1445 cotton 
− Falcon oilseed rape 
− MS8/RF3 oilseed rape 
− RR fodder beet  
− Transgenic potato 
− Liberator oilseed rape 
− Bt-11 maize (EC-69) 
− GA21 maize (EC-78) (withdrawn in September 2003) 
− MON810 x GA21 maize (withdrawn in September 2003) 
− LL soybeans (EC-71) (withdrawn in June 2004) 
− LL oilseed rape 
− BXN cotton
1341 
− Bt-1507 maize (EC-74) 
− Bt-1507 maize (EC-75) 
− NK603 maize (approved by Commission in July 2004)   
− RR oilseed rape (EC-70) (approved by Commission in August 20051342)   
− RR sugar beet (withdrawn in April 2004) 
 7.1642  The seven applications which were pending under Regulation 258/97 as of August 2003 are 
those concerning: 
− GA21 maize (food)  
− Bt-11 sweet maize (food) (approved by Commission in May 2004) 
− NK603 maize (food) (approved by Commission in October 2004) 
− LL soybeans (food) (withdrawn in July 2004) 
− Bt-1507 maize (food) 
− RR sugar beet (food) (withdrawn in April 2004)  
− MON810 x GA21 maize (food) 
 
(ii) DS292 (Canada) 
7.1643  Canada's request for the establishment of a panel identifies four applications.  They were all 
submitted under Directive 90/220.  As of A ugust 2003, they were either pending under 
Directive 2001/18 or awaiting the lead CA's written consent to the placing on the market.  Canada 
requests product-specific findings on all four applications.  The applications at issue are those concerning: 
                                                     
 
1341 According to the European Communities, the application concerning BXN cotton was withdrawn 
by the applicant after the establishment of the Panel.   However, the European Communities has provided no 
support for this assertion. 
1342 We recall that after the second substantive me eting, on 1 September 2005, the Panel received a 
letter from the European Communities stating that the Commission had approved the application concerning RR 
oilseed rape (EC-70) und er Directive 2001/18. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 696 
  
  − MS1/RF1 oilseed rape (EC-89) (awaiting the lead CA's written consent) 
− MS1/RF2 oilseed rape (awaiting the lead CA's written consent) 
− MS8/RF3 oilseed rape 
− RR oilseed rape (EC-70) (approved by Commission in September 2005
1343) 
 
(iii) DS293 (Argentina) 
7.1644  Argentina's request for the establishment of a pa nel contains an attachment, Annex I, which 
identifies seventeen applications.  It appears that An nex I is intended to illustrate the impact of the 
general de facto  moratorium on specific applications as well as to specify the applications in respect 
of which Argentina is making product-specific clai ms.  Among the seventeen a pplications referred to 
in Annex I, there are two which are mentioned twice.1344  There are four additional applications in 
respect of which Argentina makes no claims in its submissions.1345  The eleven remaining applications 
are the applications on which we think we are requ ested to make product-specific findings.  Of these 
eleven applications, six were submitted unde r Directive 90/220.  With one exception1346, they were 
pending under Directive 2001/18 on the date of establis hment of this Panel.  Argentina claims that the 
other five applications were all submitted under Regulation 258/97.   
7.1645  The six applications submitted under Directive 90/220 comprise those concerning: 
− Bt-531 cotton   
− RR-1445 cotton   
− GA21 maize (EC-78) (withdrawn in September 2003) 
− GA21 maize (EC-85) (withdrawn in June 2001) 
− NK603 maize (approved by Commission in July 2004)   
− LL soybeans (EC-71) (withdrawn in June 2004) 
 7.1646  The five applications which Argentina say s were submitted under Regulation 258/97 are 
those concerning: 
− Bt-531 cotton  
− RR-1445 cotton  
− GA21 maize (food)   
                                                     
 
1343 We recall that after the second  substantive meeting, on 1 September 2005 the Panel received a 
letter from the European Communities stating that the application concerning RR oilseed rape (EC-70) was 
approved by the Commission in September 2005.  We further note that in the context of presenting its product-
specific claims in respect of the application concerning RR oilseed rape (EC-70), Canada also presented 
arguments on RR oilseed rape (EC-79).  E.g., Canada's first written submissi on, paras. 86-87 and 295.  See also  
Canada's reply to Panel question No. 60.  The applicati on concerning RR oilseed rape (EC-79) was submitted to 
France.  However, Annex I to Canada's panel request re fers only to the application submitted to the Netherlands, 
which is that concerning RR oilseed rape (EC-70).  Acco rdingly, we will not entertain Canada's product-specific 
claims in respect of the application concerning RR oilseed rape (EC-79) submitted to France.  We consequently 
offer no product-specific findings on that application.   
1344 This is the case of the applications concerni ng GA21 maize (food) and LL soybeans (EC-71).  
Argentina in its submissions to the Panel does not argue that the applications which we consider are mentioned 
twice are in fact different applications. 
1345 This is the case of the applications concerning GA21 maize (EC-78) (alleged procedure under 
Regulation 258/97), T14 maize (procedure under Directive 90/220 and alleged procedure under 
Regulation 258/97) and LL soybeans (EC-81).  T14 maize is mentioned in footnote 188 of Argentina's first written submission, but no claim is raised there. 
1346 The application concerning GA21 maize (EC-85) was withdrawn in June 2001.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 697 
  
  − NK603 maize (food) (approved by Commission in October 2004)  
− LL soybeans (food) (withdrawn in July 2004) 
 (c) Withdrawn and approved applications 
7.1647  The above analysis shows that among the app lications in respect of which the Panel is 
requested to make product-specific findings are appli cations which were withdrawn either before or 
after the Panel was established.  There also are applications which were approved by the Commission 
in the course of the Panel proceedings.  The Eur opean Communities argues that the Panel should not 
make findings with regard to withdrawn or approv ed applications.  Accordingly, we must decide 
whether it is appropriate to assess the WTO-consiste ncy of the relevant product-specific measures. 
(i) Applications withdrawn before the establishment of the Panel 
7.1648  We note at the outset that if an application is withdrawn, this means that the product-specific 
measure complained of no longer exists.  In th e case of the application concerning GA21 maize 
(EC-85), the product-specific measure complained of by Argentina is the alleged "undue delay in 
finalizing consideration of that application".  Once that application was withdrawn, this meant that 
there no longer was an undue delay in finalizi ng consideration of that application.    
7.1649  As we pointed out earlier, the product-specifi c measure which relates to the application 
concerning GA21 maize (EC-85) is within the terms of reference of DS293 (Argentina).  
Notwithstanding this, the European Communities s ubmits that claims concerning applications 
withdrawn before the Panel was established are without  object and, hence, inadmissible ab initio. In 
our view, the mere fact that the product-specific measure concerning GA21 maize (EC-85) no longer 
existed as of the date of esta blishment of the Panel does not, ipso facto , deprive us of our authority to 
make findings on a measure that is within our terms of reference.
1347   
7.1650  This is also clear from the Appellate Body report in US – Certain EC Products .  That dispute 
concerned a measure which was withdrawn almost  two months before a panel was established.1348  
The panel considered the measure, offered findi ngs on it and recommended that it be brought into 
conformity with WTO rules.1349  The Appellate Body found that the panel should not have made a 
recommendation regarding a meas ure that no longer existed.1350  But the Appellate Body nowhere 
suggested that the panel erred in ma king findings regarding that measure.1351  We recognize that in our 
case the application concerning GA21 maize (EC-85) was withdrawn more than two years before the Panel was established.  However, th ere is nothing in the DSU to suggest  that our jurisdiction, which is 
established by our terms of reference
1352, is affected by such considerations of time.   
7.1651  Having said this, past jurisprudence shows that a panel is not necessarily required to make use 
of its authority to make findings in respect of m easures which were no longer in existence on the date 
of establishment of a panel.  In Argentina – Textiles and Apparel , the panel decided not to make 
                                                      
1347 A different issue (which we do not reach) is whether we have the authority to make 
recommendations in relation to the pr oduct-specific measure in question.  
1348 The panel in that case was established on 16 June  1999, while the measure at issue (the "3 March 
Measure") ceased to exist on 19 April 1999 when a new measure (the "19 April Action") was adopted.  
1349 Panel Report, US – Certain EC Products , para. 7.3. 
1350 Appellate Body Report, US – Certain EC Products , para. 81.  The Appellate Body in US – Upland 
Cotton , referring to its report on US – Certain EC Products , stated that "the fact that a measure has expired may 
affect what recommendation a panel may make".  Appellate Body Report,  US – Upland Cotton , para. 272.  
1351 Ibid., para. 271. 
1352 Appellate Body Report, Brazil – Desiccated Coconut , p. 22. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 698 
  
  findings on the WTO-consistency of a measure whic h had been revoked eleven days before the panel 
was established.
1353  Moreover, as noted  by the panel in US – Gasoline , "it had not been the usual 
practice of a panel established under the General Ag reement [on Tariffs and Trade 1947] to rule on 
measures that, at the time the panel's terms of refe rence were fixed, were not and would not become 
effective".1354 
7.1652  We consider that in determining whether to make findings on a measure no longer in 
existence on the date of establishment of a panel, pa nels should notably take account of the object and 
purpose of the dispute settlement system.1355  Pursuant to Article 3.7 of  the DSU, "[t]he aim of the 
dispute settlement mechanism is to secure  a positive solution to a dispute".   
7.1653  In the case of the application concerning GA21 maize (EC-85), we are not persuaded that 
making product-specific findings with regard to th at application is necessary to "secure a positive 
solution to [the] dispute" between Argentina and th e European Communities.  We note in this regard 
that there is no agreement between the Parties that it would be useful for us to make findings on the 
product-specific measure concerning the application in question.  Moreover, the application was 
withdrawn more than two years prior to the est ablishment of the Panel.  Thus, unlike in the US – 
Certain EC Products  case where the measure at issue was in for ce for just over a month, this is a case 
where Argentina could have presented its clai ms while the application was still pending.1356  Finally, 
we note that the applicant resubmitted the applic ation to another member State and that the 
resubmitted application – the application concer ning GA21 maize (EC-78) – was still pending on the 
date of establishment of this Panel.  We will make  findings on the resubmitted application.  As a 
result, we are resolving the dispute between Arge ntina and the European Communities insofar as it 
relates to GA21 maize.   
7.1654  In the light of these considerations, we w ill neither examine nor make product-specific 
findings on the application concerning GA21 maize (EC-85). 
(ii) Applications withdrawn after the establishment of the Panel  
7.1655  In relation to applications which were withdraw n after the Panel was established, we note that 
only the United States and Argentina are seeki ng product-specific findings on applications falling 
within this category.  
7.1656  The European Communities  argues that the Panel should not address product-specific 
measures concerning applications wh ich were withdrawn after the Pane l was established.  According 
to the European Communities, the is sue has become moot and the relevant claims must be considered 
inadmissible.  The European Communities bases its argument on three provisions of the DSU.  First , 
Article 3.3 of the DSU states that the basic aim of the dispute settlement system is "the prompt settlement of situations in which a Member consid ers that any benefits accruing to it directly or 
indirectly under the covered agreements are being  impaired by measures taken by another Member" 
(emphasis added).  This shows that the purpose of dispute settlement is to address and redress 
situations that are in actual existence.  Secondly , Article 3.4 of the DSU provides that 
                                                     
 
1353 Panel Report, Argentina – Textiles and Apparel , para. 6.15. 
1354 Panel Report, US – Gasoline , para. 6.19.  
1355 This approach is consistent with that of the panel in Chile – Price Band System , which stated that 
"[a]lthough we do not consider that the terminati on of a measure before the commencement of panel 
proceedings deprives a panel of the authority to make findings in respect of  that measure, we would only make 
findings regarding the provisional safeguard measures in th is case if we were to consid er this necessary in order 
to 'secure a positive solution' to the dispute."  Panel Report, Chile – Price Band System , para. 7.115. 
1356 We note that the application wa s first submitted in December 1997.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 699 
  
  "recommendations or rulings by the DSB shall be ai med at achieving a satisfactory settlement of the 
matter".  This cannot be the case if there is no matter to settle (i.e., if no measure is being applied).  
Thirdly , Article 3.7 of the DSU provides that "befor e bringing a case a Member shall exercise its 
judgment as to whether action under these procedures would be fruitful.  The aim of the dispute 
settlement mechanism is to secure a positive solution to a dispute".  A case on a measure that is not in 
existence any longer would be de void of any purpose and not fruitf ul.  The European Communities 
also points out that it is a legal principle recognized in jurisdictions around the world and commonly applied by international tribunals, including the Inte rnational Court of Justice (the "ICJ"), that a 
tribunal should not rule on a measure no longer in existence.
1357   
7.1657  The United States  argues that the concept of mootness is of no relevance, since the product-
specific measures existed in August 2003, when the te rms of reference were set.  The United States 
refers to the panel report on India – Autos , which states that "[a] WTO Panel is generally competent to 
consider measures in existence at the time of its establishment. This power is not necessarily 
adversely affected simply because a measure under re view may have been subsequently removed or 
rendered less effective".1358    Regarding the European Communities'  argument with regard to a "legal 
principle" concerning mootness, the United Stat es notes that the European Communities failed to 
mention that GATT and WTO panels in the past considered terminated measures, and that the 
European Communities failed to expl ain how such a principle would be consistent with the text of the 
DSU.     
7.1658  Argentina  argues that the European Communities' statement on mootness is not supported by 
WTO jurisprudence.  Argentina refers to the panel report on Chile – Price Band System , wherein the 
panel stated that "Article 19.1 of DSU does not  prevent us from making findings regarding the 
consistency of an expired pr ovisional safeguard measure".1359  Argentina also refers to the above-
quoted passage from the panel report  on India – Autos .  
7.1659  Subsequently, the European Communities  clarified its position.  It notes that it is not its 
position that the Panel may not consider product- specific measures concerning applications which 
were withdrawn after the Panel was established.1360  But the European Communities remains of the 
view that such measures are " sans objet ", and that there is no longer any utility in considering such 
measures because there does not exist, in respect of  such measures, a dispute between the Parties. 
7.1660  The Panel  notes that there is no disagreement among the Parties that the product-specific 
measures which relate to applications withdrawn af ter the establishment of the Panel are within the 
Panel's terms of reference.  There also is no disag reement among the Parties that the Panel in principle 
has the authority to consider measures which ceased to  exist after the establishment of the Panel.  We 
agree with both points.  In relation to the second point  – the authority of panels to consider measures 
which ceased to exist after the establishment of  a panel – we note that the panel in India – Autos  
observed that:   
                                                      
1357 The European Communities refers to the following ICJ judgments: Questions of Interpretation and 
Application of the 1971 Montreal Convention ra ising from the Aerial Incident at Lockerbie  (Libyan Arab 
Jamahiriya v. United States of America), Judgment, ICJ Reports 1998, at 131, para 45; Nuclear Tests (Australia 
v. France), Judgment, ICJ Reports 1974, p.272, para 62; and  Border and Transborder Armed Actions 
(Nicaragua v. Honduras), Jurisdiction and Admissibility, Judgment, ICJ Reports 1988, p.95, para. 66. 
1358 Panel Report, India – Autos , para. 7.26.   
1359 Panel Report, Chile – Price Band System,  para. 7.124. 
1360 The European Communities nonetheless notes that the Panel should not issue recommendations in 
respect of such measures. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 700 
  
  "A WTO Panel is generally competent to consider measures in existence at the time 
of its establishment. This power is not necessarily adversely affected simply because a measure under review may have been subsequently remove d or rendered less 
effective."
1361  
7.1661  The Parties disagree on whether the Panel should make use of its authority to make findings 
on the product-specific measures concerning the withdr awn applications.  The European Communities 
argues that it is no longer useful for the Panel to consider the relevant product-specific measures, and 
that the Panel should therefore refrain from ruli ng on these measures.  According to the European 
Communities, this would be consiste nt with international practice, including that of the International 
Court of Justice. 
7.1662  In considering this issue, we note that prev ious panels have addressed measures which ceased 
to exist after the establishment of the panel.  The panel in  Indonesia – Autos  stated in this regard that: 
"[I]n previous GATT/WTO cases, where a measure included in the terms of reference 
was otherwise terminated or amended after the commencement of the panel 
proceedings, panels have nevertheless made findings in respect of such a 
measure."1362 
7.1663  We would agree with the European Communities th at it may be appropriate for panels to look 
to the practice of international tribunals for inspir ation, particularly in situations where the WTO 
agreements, GATT/WTO jurisprudence or practice provi de no useful guidance.  But we do not find 
ourselves in a situation of this kind.  As is clea r from the above remarks, there is specific GATT/WTO 
jurisprudence and practice to guide us.  In these circumstances, we see no need to draw on the 
jurisprudence of the International Court of Justice. 
7.1664  We do not consider that Articles 3.3 or 3.4 of the DSU support the view that we should 
refrain from making findings on the relevant product-speci fic measures.  In relation to Article 3.3, the 
European Communities appears to argue that if bene fits are no longer "being" impaired by a measure, 
because the measure has ceased  to exist, the Panel should not make findings on it.  However, the main 
objective of Article 3.3 is to emphasise the importance of the prompt  settlement of situations in which 
benefits are being impaired by a measure.  In our view, it cannot be deduced from this that in 
situations where benefits are no longer being im paired by a measure, a panel should refrain from 
making findings on it. We note that pursuant to Artic le 3.2 of the DSU the dispute settlement system 
also serves "to preserve the rights and obligations of Members under the covered agreements".  We 
think that it is consistent with this function of the dispute settlement system for a panel to make 
findings on the WTO-consistency of a measure whic h has ceased to exist, especially if so requested 
by one of the parties.   
7.1665  Turning to Article 3.4, we note that that pr ovision states that recommendations or rulings by 
the DSB must be aimed at achieving a satisfactor y settlement of the "matter".  The European 
Communities suggests that if a measure has ceased to ex ist, there is no longer a "matter" to be settled.  
However, the "matter" to be settled is the matter re ferred to the DSB for settlement.  As is clear from 
Article 7.1 of the DSU and the Appellate Body report in Guatemala – Cement I1363, the matter referred 
to the DSB is the matter described  by a Complaining Party in its request for the establishment of a 
panel.  Pursuant to Article 6.2 of the DSU, the request for establishment of a panel must identify the 
                                                      
1361 Panel Report, India – Autos , para. 7.26. 
1362 Panel Report, Indonesia – Autos , para. 14.9.  
1363 Appellate Body Report, Guatemala – Cement I , para. 72.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 701 
  
  specific measures at issue.  Applying these consider ations to the present case, it is clear that the 
"matter" to be settled by the DSB in a satisfact ory manner includes the product-specific measures 
identified by the United States and Argentina in thei r respective panel requests.  Therefore, we do not 
agree that once the relevant product-specific measures ceased to exist, there was, to that extent, no 
longer a "matter" which could be settled by the DSB. 
7.1666  Regarding whether it is useful for the Pa nel to address the product-specific measures 
concerning the withdrawn applications, we recall our view that in making that determination, account 
should notably be taken of the object and purpose of the dispute settlement system, which is to secure 
a positive solution to a dispute.  We note in this rega rd that there is no agreement between the Parties 
that it would be useful for us to make findi ngs on the product-specific measures concerning the 
applications in question.  However, the United St ates and Argentina as Complaining Parties did not 
say that in view of the withdrawal of the app lications in question, they were no longer seeking 
findings on the product-specific measures concerning th ese applications.  On the contrary, Argentina, 
for instance, explicitly requested th e Panel to offer such findings.  Moreover, unlike in the case of the 
application concerning GA21 maize (EC-85), our findings on other product-specific measures do not 
resolve the dispute relating to the relevant biotech  products.  Finally, we note that the applications 
were withdrawn by the applicants.  It is clear, th erefore, that this is not a case where the relevant 
measures were terminated by the responding party in  the course of panel proceedings in a good faith 
effort to resolve the underlying dispute.  Thus, we do not consider that if we make findings on the 
product-specific measures at issue, we would be frustrating efforts undertaken to reach a positive 
solution to the dispute.  In these circumstanc es, we are unable to agree with the European 
Communities that it is no longer useful for us to  offer findings on the product-specific measures at 
issue. 
7.1667  In the light of the above, the Panel will make findings on the product-specific measures 
concerning those applications which were w ithdrawn after the Panel was established.   
(iii) Applications approved after the establishment of the Panel  
7.1668  The last category of applicati ons to be addressed concerns a pplications which were approved 
by the Commission in the course of the Panel pro ceedings.  All three Complaining Parties are seeking 
product-specific findings on such applications.  In our view, applications which were definitively  
approved
1364 in the course of the Panel proceedings may be assimilated, for the purposes of the present 
inquiry, to applications which were withdrawn in the course of the Panel proceedings.  Both 
categories of applications have in common the fact that the underlying approval procedures were 
pending on the date of establishment of the Panel,  but were subsequently discontinued.  The only 
difference is that in the case of a definitively approved a pplication, the relevant approval procedure 
was discontinued as a result of action directly attr ibutable to the European Communities.  We do not 
consider that this difference, by itself, warrants a different approach by the Panel.  We note in this 
regard that the European Communities does not argue  that the Commission approved applications in 
order to resolve its dispute with the Complaining Parties in relation to the relevant applications.1365   
                                                      
1364 We use the phrase "definitively approved" to refer to a situation where according to information on 
our record the applicant may proceed w ith the placing on the market of the biotech product which is the subject 
of the approved application.   
1365 The European Communities argues that the approvals of the relevant applications are simply the 
consequence of these applications having reached the final decision-m aking stage after being assessed at 
member State and Community level.  EC comments on the Complaining Parties' replies to Panel questions, 
paras. 62-63. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 702 
  
  7.1669  In the light of this, the Panel will make findings  also with regard to those product-specific 
measures that concern applications which were definitively approved in the course of the Panel 
proceedings.  The evidence on record supports the conclusion that two app lications – namely, the 
application concerning Bt-11 sweet maize (food) an d the application concerning NK603 maize (food) 
– were definitively approved in the course of th e Panel proceedings.  Fo r the other relevant 
applications approved by the Commission in the co urse of the Panel proceedings, the record does not 
allow us to determine whether these applications have  been definitively approved, such that they may 
be placed on the market.
1366  In any event, it is clear from the foregoing that we would offer findings 
on product-specific measures concerning such appli cations even if they had been definitively 
approved after the date of the establishment of the Panel.   
(iv) Conclusion   
7.1670  In the light of the foregoing considerations, we will offer no findings on the product-specific 
measure concerning GA21 maize (EC-85) (DS293), but we will make findings on product-specific 
measures concerning applications which were wit hdrawn after the Panel was established as well as on 
the product-specific measure concerning Bt-11 sweet maize (food) (DS291), an application which was 
definitively approved in the course of the Panel proceedings.  However, we will not make any 
recommendations in the event that we find that th e product-specific measures concerning applications 
which were withdrawn after the Panel was established, or the product-specific measure concerning 
Bt-11 sweet maize (food) (DS291), are WTO-inconsistent.   
2. Claims of inconsistency raised by the Complaining Parties 
7.1671  The Complaining Parties have each presented a serie s of claims of inconsistency in relation to 
the European Communities' product-speci fic EC measures they are challenging 
7.1672  The United States  claims that the product-specific EC measures it is challenging are 
inconsistent with, or have given rise to inc onsistencies with, the following WTO provisions:1367  
(a) Annex C(1)(a) and, consequently, Article 8 of the SPS Agreement ; 
(b) Annex B(1) and, consequently, Article 7 of the SPS Agreement ; 
(c) Annex C(1)(b) and, consequently, Article 8 of the SPS Agreement ; 
(d) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement ;  
(e) Article 5.5 of the SPS Agreement .    
7.1673  Canada  claims that the product-specific EC measur es it is challenging are inconsistent with, 
or have given rise to inconsistencies with, the following WTO provisions:1368  
                                                      
1366 We note in this regard that in relation to the applications concerning NK603 maize (for animal feed 
use) and RR oilseed rape (EC-70) the record contains no evidence that the relevant lead CA has given its written 
consent for the placing on the market  of these products after they were approved by the Commission under 
Directive 2001/18.   
1367 The claims are listed in the order in which they were developed in the first written submission of 
the United States. 
1368 The claims are listed in the order in which they were developed in the first written submission of 
Canada.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 703 
  
  (a) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement ;     
(b) Article 5.6 and, consequently, Article 2.2 of the SPS Agreement ; 
(c) Article 5.5 and, consequently, Article 2.3 of the SPS Agreement ;
1369    
(d) Annex C(1)(a) and, consequently, Article 8 of the SPS Agreement ; 
(e) Article III:4 of the GATT 1994;  
(f) Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the TBT Agreement .  
7.1674  With regard to Canada's claims under the TBT Agreement , Canada explained that, if the Panel 
determines that parts of the relevant pr oduct-specific measures are covered by the TBT Agreement  in 
addition to the SPS Agreement , its claims under the TBT Agreement  are to be considered cumulative 
rather than alternative.   
7.1675  Argentina  claims that the product-speci fic EC measures are inconsistent with, or have given 
rise to inconsistencies with, the following WTO provisions:1370  
(a) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement ;  
(b) Articles 5.5 and 5.6 of the SPS Agreement ; 
(c) Annex C(1)(a), (b), (c) and (e) a nd, consequently, Article 8 of the SPS Agreement ; 
(d) Article III:4 of the GATT 1994; 
(e) Articles 2.1, 2.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2 and 12 of the TBT Agreement .  
7.1676  As previously indicated, the Panel will make fi ndings in relation to ten product-specific EC 
measures challenged by Argentina.  However, Arge ntina's claims under Article 8 and Annex C(1) of 
the SPS Agreement  and those under Article 5.2 of the TBT Agreement  concern only eight of the ten 
"relevant product-specific measures".  The two measures which are not the subject of a claim under these provisions are the measures affecting the a pproval of Bt-531 cotton and RR-1445 cotton under 
Regulation 258/97.   
7.1677  We further note that Arge ntina's claims under the TBT Agreement  are put forth as alternatives 
to its claims under the SPS Agreement . 
7.1678  The European Communities  argues that none of the product-specific claims presented by 
the three Complaining Parties is founded, and that it  has not acted inconsistently with any of the WTO 
provisions which are being invoked by the Complain ing Parties in respect of any of the product-
specific measures.  
7.1679  In view of the European Communities' view that all of the Complaining Parties' product-
specific claims should be dismissed in their entirety, it is clear that the Panel  needs to assess the 
merits of those claims.  We will first examine the Complaining Parties' substantive claims under 
                                                     
 
1369 Canada's claim under Article 5.5 is put forth as an alternative to its claim under Article 5.6.  
1370 The claims are listed in the order in which they were developed in the first written submission of 
Argentina. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 704 
  
  Articles 5 and 2 of the SPS Agreement , and, if appropriate, will go on to examine the transparency 
claim under Annex B of the SPS Agreement  and the procedural claims under Annex C of the 
SPS Agreement .  Finally, to the extent it is necessary to do so, we will also examine Canada's and 
Argentina's claims under the GATT 1994 and under the TBT Agreement . 
3. Consistency of the product-specific measures with Article 5.1 of the SPS Agreement  
7.1680  All three Complaining Parties claim that the European Communities has acted inconsistently 
with its obligations under Article 5.1 of the SPS Agreement  in respect of the product-specific 
measures they are challenging.  
7.1681  Article 5.1 of the SPS Agreement  provides: 
"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." 
7.1682  The United States  argues that like the general moratorium, to the extent the product-specific 
measures – the product-specific moratoria – are preventing the sale or marketing of biotech products, each failure by the European Communities to consider for approval a pending application of a biotech 
product is an "SPS measure" that is not "based on a risk assessment" as required by Article 5.1.  The 
United States considers that the product-specific morato ria, which, in effect, ban the relevant biotech 
products from the EC market, are "SPS measures" as defined in Annex A(1) of the SPS Agreement .  
The EC approval regime, including that part of the re gime modified by the product-specific moratoria, 
are plainly "sanitary or phytosanitary" measures.  Similarly, the product-specific moratoria, although 
unwritten, are "measures" under the SPS Agreement , just as the general mo ratorium affecting all 
products is a "measure" under the SPS Agreement .  Regarding the requirement that SPS measures be 
based on a risk assessment, the United States submits that with respect to fourteen of the pending 
applications, the European Commun ities has not put forth any risk asse ssment whatsoever.  As for the 
remaining thirteen applications, the European Communities has undertaken risk assessments but the 
product-specific moratoria are not  based on these assessments.   
7.1683  Canada  argues that the failure of the European Communities to consider or approve, without 
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in 
Annex A(1).  According to Canada, the failure to  consider and approve these applications, which 
Canada refers to as the "product-specific marketing bans", is not "based on" risk assessments contrary 
to Article 5.1.  While the European Communities ha s completed risk assessments for each of the four 
applications, it has failed to base its failure to consider, and approve, these applications on these 
assessments. 
7.1684  Argentina  argues that the suspension of considera tion of, or the failure to consider, the 
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the 
requirements of Article 5.1 because it is not based on  any risk assessments.  Argentina points out that 
there are applications that have not been approved in  spite of the fact that member States or the EC 
scientific committees have conducted risk assessments and th e assessments were favourable.  In these 
cases, the requirements of Article 5.1 have not b een met because the favourable risk assessment has 
not been taken into consideration.  Other appli cations have had their processing suspended without 
any risk assessment having been conducted either by me mber States or EC scientific committees.  In 
these cases, the requirements of Article 5.1 ha ve not been met because no risk assessment was  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 705 
  
  performed on account of the suspension of considera tion of, or failure to consider, the relevant 
applications.     
7.1685  The European Communities  argues that the delays (or failure to act within a specific 
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the 
SPS Agreement  as an issue of application  of an SPS measure and more specifically, of the approval 
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the 
Complaining Parties here thus cannot constitute an  SPS measure in the sense of Annex A(1).  As a 
matter of logic, it is clear that alleged behaviour by a Member ca nnot be an SPS measure itself as well 
as the application of another SPS measure.  As th e delays of the kind alleged by the Complaining 
Parties do not fall within the definition of an SPS measure defined by Annex A(1), the European 
Communities considers that Article 5.1 is  not applicable to these delays.    
7.1686  The Panel  notes that, by its clear terms, Article 5.1 applies to SPS measures.  Accordingly, 
for a particular product-specific measure to be subject  to Article 5.1, it must be an SPS measure.  The 
European Communities contests that the product- specific measures constitute SPS measures within 
the meaning of Article 5.1.  It is theref ore necessary to consider this issue.   
7.1687  We recall that the Complaining Parties have stat ed that the product-specific measures they are 
challenging are related to the general moratorium on approvals.  We have observed that based on 
these statements we understand that the product-specific measures are, or arise from: 
− specified acts and/or omissions through wh ich the relevant EC entities were giving 
effect, in the context of particular approva l procedures, to their decisions to impose a 
general moratorium on approvals, or 
− specified acts and/or omissions through whic h relevant EC entities chose to respond, 
again in the context of particular approval procedures, to the circumstance that other 
EC entities were imposing a gene ral moratorium on approvals. 
 7.1688  In relation to the general moratorium on appr ovals, we have found earlier that the European 
Communities' decision to apply a general moratori um on approvals was not a decision effectively 
imposing an across-the-board definitive marketing ba n, but a decision concerning the application, or 
operation, of approval procedures.  We also found that the decision in question was not, itself, a measure applied to achieve the European Commun ities' appropriate level of protection.  These 
findings led us to conclude that the European Co mmunities' decision to apply a general moratorium 
on approvals was not an "SPS measure" within the meaning of Annex A(1) and Article 5.1.   
7.1689  If, as we believe, the European Communities' decision to apply a general moratorium on 
approvals was not an "SPS measure", logic suggest s that the same should be true for the product-
specific measures, considering that, in our unders tanding, they essentially are acts and/or omissions 
through which relevant EC entities were giving eff ect to the decision to apply a general moratorium 
on approvals, or through which they were reacting to the circumstance  that other EC entities were 
imposing a general moratorium.
1371  Notwithstanding the fact that there is a logical link between the 
general moratorium and the product-specific measures,  it is appropriate to examine in more detail 
whether the latter measures constitute SPS measur es within the meaning of Annex A(1) and 
Article 5.1.  As the Complaining Parties have provi ded slightly different de scriptions of the product-
                                                      
1371 We recall that in relation to the second categor y of acts and/or omissions, the Complaining Parties 
essentially allege that applications were processed at  a delayed pace in view of the existence of a general 
moratorium on final approvals until certain conditions were met. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 706 
  
  specific measures of which they are complaini ng, we examine this issue separately for each 
Complaining Party.
1372   
(a) DS291 (United States) 
7.1690  As we have previously noted, the United Stat es is challenging the alleged failure by the 
European Communities to consider particular appli cations for final approval.  We recall that for a 
particular measure to be subject to Article 5.1 it mu st be an "SPS measure".  To determine whether the 
European Communities' alleged fa ilure to consider a particular  application for final approval 
constitutes an "SPS measure", we first look to the defi nition of that term set out in Annex A(1) of the 
SPS Agreement .  According to Annex A(1), SPS measures include "requirements and procedures". 
7.1691  Regarding "requirements", we note that failure to  consider a particular application for final 
approval, even if intentional, is not the same  thing as a negative final approval decision on that 
application.  Nor does failure to consider for fi nal approval necessarily lead to, or predetermine, a 
negative final approval decision.  Consequently, we are of the view that the European Communities' 
alleged failure to consider a pa rticular application for final a pproval would not have imposed a 
substantive SPS "requirement" within the meaning of the Annex A(1) definition of the term "SPS 
measure".    
7.1692  The United States argues, however, that, in eff ect, the European Communities' alleged failure 
to consider particular applicati ons for final approval banned the rele vant biotech products from the EC 
market.  We would agree that failure to consider  a particular application for final approval would 
ordinarily result in delays in the completion of the relevant approval procedure.  In turn, these delays 
would have the effect of extending the time-peri od during which the biotech product in question was 
subject to the provisional marketing ban flowing from the EC pre-marketing approval requirement.  
But a failure to consider a particular application for final approval would not have imposed a new ban; 
a ban was already in place, as a consequence of the pre-marketing approval requirement.  In other 
words, the origin of the provisional marketing ban,  including of the effectively extended ban, would 
not have been the failure to consider the releva nt application for final approval, but the EC pre-
marketing approval requirement, i.e., the European Communities' substantive decision to ban biotech 
products until they have been approved.   
7.1693  Consistent with the foregoing, we agree that fa ilure to consider a particular application for 
final approval would have had an impact on how lo ng the provisional marketing ban was in place for 
the relevant biotech product.  Yet we are unable to ag ree that a failure to consider an application for 
final approval effectively woul d have imposed a new marketing ban, and, hence, a negative 
"requirement", on the biotech product concerned.  If the United States had been of the view that the 
aforementioned impact on the provisional market ing ban resulted in that ban being applied 
inconsistently with Article 5.1, it w as open to it to challenge that ban ( i.e., the pre-marketing approval 
requirement) as the source of the provisional marketing ban.  The United States chose not to do so in 
this case. 
7.1694  Regarding "procedures", we note the United Stat es' argument that the European Communities' 
alleged failure to consider par ticular applications for final a pproval "modified" part of the EC 
approval regime.  Since the alleged product-specifi c measures in question would not, in our view, 
have imposed any new substantive requirement, we do not think that they would have modified any 
substantive requirement which is part  of the EC approval regime.  What remains to be examined, then, 
                                                      
1372 See also  our discussion of the Complaining Parties' Article 5.1 claim in Section VII.D.5 above.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 707 
  
  is whether the product-specific measures would have modified the relevant EC approval 
procedures.
1373   
7.1695  Clearly, the European Communities' alleged failure  to consider a particular application for 
final approval would not itself have constituted, or established, a pro cedure for approving the relevant 
biotech product or, more to the point, for preventing the final approval of this biotech product.  The 
failure to consider a particular application for fi nal approval also would not have effectively amended 
the relevant EC approval procedure for the speci fic biotech product in question.  As we have 
explained in earlier findings on the general morato rium on approvals, the European Communities did 
not apply a different type of approval procedure.  The applications in question continued to be 
assessed in accordance with  the procedure set out in Directives 90/220 and 2001/18, as well as 
Regulation 258/97.  Therefore, we are not persuaded that the alleged failure to consider a particular 
application for final approval woul d have "modified" the relevant EC  approval procedure.  In our 
assessment, the foregoing also leads to  the conclusion that the alleged failure to consider a particular 
application for final approval cannot be considered  a "procedure" within the meaning of Annex A(1). 
7.1696  Thus far, we have found that the European  Communities' alleged failure to consider a 
particular application for final approval qualifi es neither as a "requirement" nor as a "procedure" 
within the meaning of Annex A(1).  But we have not yet determined in positive terms what is the 
legal nature of the failure in question.  We thi nk the United States' reference to the failure by the 
European Communities to consider a particular a pplication for final approval should be understood, 
and makes sense, as a reference to the applicati on by the European Communities of a particular way 
of operating the relevant EC approval procedure – a way which reflected the intention, or the 
anticipation, that there would be no final approval decision on the application in question until certain 
conditions were met.  In other words, we think th at, in essence, the United States is complaining of a 
particular manner of operating the EC approval procedures in specific cases.   
7.1697  In terms of Annex A(1), this means that we ar e concerned with the application, or operation, 
of "procedures".  As we have said in our earlier findings, while "procedures" as such may according 
to the Annex A(1) definition constitute SPS measur es, the application, or operation, of such 
procedures does not, itself, constitute an SPS measure within the meaning of Annex A(1).  Accordingly, we come to the conclusion that the European Communities' alleged failure to consider a 
particular application for final approval does not meet  all of the constituent elements of the definition 
of the term "SPS measure" as provided in Annex A(1).   
7.1698  Turning now to Article 5.1, we recall our ear lier finding that the term "SPS measure" in 
Article 5.1 should be interpreted to refer to a me asure applied for achieving the relevant Member's 
appropriate level of sanitary or phytosanitary prot ection.  In our view, the European Communities' 
alleged failure to consider a par ticular application for final approva l would not, itself, have been a 
measure applied for achieving the European Comm unities' appropriate le vel of sanitary or 
phytosanitary protection.  Rather, as we have said, it would have been the application of a particular 
way of operating the relevant EC approval procedure.   As we explained above, the practical effect of 
the alleged failure to consider a particular appli cation for final approval would have been to extend 
the time-period during which the relevant biotech  product was subject to the provisional marketing 
ban flowing from the pre-marketing approval require ment.  The pre-marketing approval requirement 
which imposes the provisional marketing ban is a measure applied to achieve the European 
Communities' level of protection, but that requi rement is a separate measure from the European 
Communities' alleged failure to cons ider a particular application for final approval.  By itself, the 
                                                     
 
1373 The relevant approval procedures are set out in Directive 90/220 and its successor, 
Directive 2001/18, as well as Regulation 258/97.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 708 
  
  alleged failure to consider a particular applica tion for final approval woul d not have achieved or 
implied a particular level of protection.   
7.1699  As the European Communities' alleged failure to  consider a particular application for final 
approval would not, itself, have been a measur e applied for achieving the European Communities' 
appropriate level of sanitary  or phytosanitary protection, it cannot, in our view, be considered an "SPS 
measure" within the meaning of Article 5.1.   
7.1700  Based on the above considerations, we thus determine that the European Communities' 
alleged failure to consider a par ticular application for final approva l cannot be considered an "SPS 
measure" within the meaning of Article 5.1 and A nnex A(1).  As only "SPS measures" are subject to 
the provisions of Article 5.1, it follows that the pr ovisions of Article 5.1 are not applicable to the 
European Communities' alleged failure to consider particular applicati ons for final approval.  In view 
of this conclusion, we need not continue our analys is of the United States' claim under Article 5.1.   
(b) DS292 (Canada) 
7.1701  In relation to DS292, we have noted above that  Canada is challenging the alleged failure by 
the European Communities to consider or approve, w ithout undue delay, particular applications of 
specific interest to Canada.  Canada also refers to th is failure to consider or approve applications as an 
effective "product-specific marketing ban".    
7.1702  Regarding Canada's reference to an effective product-specific marketing ban, we note that we 
have already addressed a similar argument of the Un ited States.  Thus, we need only recall that we 
agree that the alleged failure by the European Communities to consider or approve a particular 
application would have had an impact on how long the provisional marketing ban resulting from the 
EC pre-marketing approval requirement was in place for the relevant biotech product.  But we are 
unable to agree that the alleged failure to consider  or approve an application effectively would have 
imposed a new marketing ban, and, hence, a negative "requirement", on the biotech product 
concerned. 
7.1703  Instead, similar to what we have said of th e measures challenged by the United States, we 
consider that Canada's reference to the failure by the European Communities to consider or approve a 
particular application should be unde rstood, and makes sense, as a reference to the application by the 
European Communities of a particular way of opera ting the relevant EC approval procedure – a way 
which reflected the intention, or the anticipation, that there would be no final approval decision on the 
application in question until certain  conditions were met.  Thus, we think that, in essence, Canada is 
complaining of a particular manner of operating th e EC approval procedures in specific cases.   
7.1704  For the same reasons as those we have given in the context of our analysis of the measures 
challenged by the United States, the type of measure  Canada is challenging in our view (i) does not 
itself constitute an SPS measure within the meaning of  Annex A(1) and (ii) is not a measure applied 
for achieving the European Communities' appropriate level of sanitary or phytosanitary protection and 
hence cannot be considered an "SPS measure"  within the meaning of Article 5.1.   
7.1705  As only "SPS measures" are subject to the provisions of Article 5.1, it follows that the 
provisions of Article 5.1 are not applicable to the European Communities' alleged failure to consider 
or approve particular applications.  In view of this conclusion, we need not continue our analysis of 
Canada's claim under Article 5.1.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 709 
  
  (c) DS293 (Argentina) 
7.1706  In relation to DS293, we note that Argen tina makes claims under Article 5 of the 
SPS Agreement  regarding all ten applications in respect  of which the Panel has decided to offer 
product-specific findings.  We first address the appl ications concerning Bt-5 31 cotton and RR-1445 
cotton which Argentina says have yet to  be approved under Regulation 258/97. 
(i) Product-specific measures affecting the approval  of Bt-531 cotton and RR-1445 cotton under 
Regulation 258/97 
7.1707  Argentina challenges under Article 5.1 the susp ension of consideration of, or failure to 
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted 
for "approval"
1374 under Regulation 258/97.   
7.1708  Argentina has provided no evidence of the exis tence of applications concerning Bt-531 cotton 
and RR-1445 cotton which were submitted for "a pproval" under Regulation 258/97.  The only 
evidence provided by Argentina in support of its claim relates to cottonseed oil derived from Bt-531 
cottonseed or RR-1445 cottonseed.  These products were subject to the simplified procedure set out in 
Article 5 of Regulation 258/97.  As indicated by us earlier, under the simplified procedure, there are 
no "applications" for the placing on the market of subject products which are then "approved" by member State assessment bodies.  Moreover, in its requ est for the establishment of a panel, Argentina 
identifies Bt-531 cotton and RR-1445 cotton as a rele vant biotech product, but not cottonseed oil 
derived from Bt-531 cottonseed or RR-1445 cottonseed .  Thus, cottonseed oil derived from Bt-531 
cottonseed or RR-1445 cottonseed is outside the terms of reference of DS293 (Argentina).    
7.1709  In view of the fact that we have seen no ev idence that applications concerning Bt-531 cotton 
and RR-1445 cotton were submitted fo r approval under Regulation 258/97,  we find that Argentina has 
failed to meet its burden of demonstrating the existe nce of a suspension of consideration of, or failure 
to consider, Bt-531 cotton and RR-1445 cotton fo r approval under Regulation 258/97.  As the 
existence of these product-specifi c measures has not been demonstrated, we cannot but reject 
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under 
Article 5.1 in relation to these alleged measures. 
(ii) Other product-specific measu res challenged by Argentina 
7.1710  We now turn to address the remaining eight pro duct-specific measures in respect of which the 
Panel has decided to make findings.  As noted, Ar gentina describes the product-specific measures it is 
challenging under Article 5.1 as the suspension by th e European Communities of consideration of, or 
the failure to consider, particular appli cations of interest to Argentina.   
7.1711  As with the measures challenged by the United St ates, we are of the view that the measures 
challenged by Argentina qualify neither as "require ments" nor as "procedures" within the meaning of 
Annex A(1).  Instead, we think Arge ntina's reference to the suspension of consideration of, or failure 
to consider, a particular application should be u nderstood, and makes sense, as a reference to the 
application by the European Communities of a part icular way of operating th e relevant EC approval 
procedure – a way which reflected the intention, or  the anticipation, that there would be no final 
approval decision on the application in question until cer tain conditions were met.  In other words, we 
think that, in essence, Argentina is complaining of  a particular manner of operating the EC approval 
procedures in specific cases.   
                                                     
 
1374 Argentina's first written submission, paras. 201-202. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 710 
  
  7.1712  For the same reasons as those we have given in the context of our analysis of the measures 
challenged by the United States, the type of measure  Argentina is challenging in our view (i) does not 
itself constitute an SPS measure within the meaning of  Annex A(1) and (ii) is not a measure applied 
for achieving the European Communities' appropriate level of sanitary or phytosanitary protection and 
hence cannot be considered an "SPS measure"  within the meaning of Article 5.1.   
7.1713  As only "SPS measures" are subject to the provisions of Article 5.1, it follows that the 
provisions of Article 5.1 are not applicable to the European Communities' alleged suspension of 
consideration of, or failure to cons ider, particular applications.  In view of this conclusion, we need 
not continue our analysis of Argentina's claim under Article 5.1. 
(d) Conclusions 
7.1714  In the light of the above, the Panel reaches the following conclusions: 
 (i) DS291 (United States) 
 
  With reference to DS291, and having rega rd to the arguments and evidence submitted 
by the United States and the European Co mmunities, the Panel concludes that the 
European Communities has not acted inc onsistently with its obligations under 
Article 5.1 of the SPS Agreement  in respect of any of the product-specific measures 
on which the Panel is offering findings.  
 
 (ii) DS292 (Canada) 
   With reference to DS292, and having rega rd to the arguments and evidence submitted 
by Canada and the European Communities, the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.1 of the 
SPS Agreement  in respect of any of the relevant product-specific measures.      
  (iii) DS293 (Argentina)    With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.1 of the 
SPS Agreement  in respect of any of the product-specific measures on which the Panel 
is offering findings.  
 
4. Consistency of the product-specific measures with Article 5.6 of the SPS Agreement  
7.1715  Canada and Argentina claim that the European Communities has acted inconsistently with its 
obligations under Article 5.6 of the SPS Agreement  in respect of the product-specific measures they 
are challenging.  
7.1716  Article 5.6 of the SPS Agreement  provides: 
"Without prejudice to paragraph 2 of Artic le 3, when establishing or maintaining 
sanitary or phytosanitary measures to achieve the appropriate level of sanitary or 
phytosanitary protection, Members shall en sure that such measures are not more 
trade-restrictive than required to achieve their appropriate level of sanitary or  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 711 
  
  phytosanitary protection, taking into account technical and economic feasibility." 
(footnote omitted) 
7.1717  Canada  argues that the failure of the European Communities to consider or approve, without 
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in 
Annex A(1).  The failure to consider and approve these applications, which Canada refers to as the 
"product-specific marketing bans", is "more trade rest rictive than required", contrary to Article 5.6.  
This is because there is another SPS measure that  is reasonably available, taking into account 
technical or economic feasibility; achieves the Eur opean Communities' appropriate level of sanitary 
and phytosanitary protection; and is significantly less restrictive to trade than the contested SPS 
measure.   
7.1718  Argentina  argues that the suspension of considera tion of, or the failure to consider, the 
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the 
requirements of Article 5.6.  This violation of Article  5.6 results from the fact that there exists another 
SPS measure that: (1) is reasonably available taki ng into account technical and economic feasibility; 
(2) achieves the European Communities' appropriate level of sanitary and phytosanitary protection; 
and (3) is significantly less restrictive to  trade than the contested SPS measure.   
7.1719  The European Communities  argues that the delays (or failure to act within a specific 
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the 
SPS Agreement  as an issue of application  of an SPS measure and more specifically, of the approval 
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the 
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1).  As a matter 
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the 
application of another SPS measure.  As the delays of the kind alleged by the Complaining Parties do 
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities 
considers that Article 5.6 is not applicable to these delays.    
7.1720  The Panel  will analyse Canada's and Argentina's claim separately.
1375 
(a) DS292 (Canada) 
7.1721  In relation to DS292, we note that for a particul ar measure to be subject to Article 5.6 it must 
be an SPS measure.  We also note that Article 5.6 explicitly refers to "[SPS] measures to achieve the 
appropriate level of sanitary or phytosanitary protec tion".  Furthermore, we recall that in the context 
of our earlier analysis of Canada's claim under Artic le 5.1 we found that the type of measure Canada 
is challenging in our view (i) does not itself c onstitute an SPS measure within the meaning of 
Annex A(1) and (ii) is not a measure applied fo r achieving the European Communities' appropriate 
level of sanitary or phytosanitary protection.  It fo llows from these elements that the alleged failure by 
the European Communities to consider or approve a particular application cannot be considered an 
"SPS measure" within the meaning of Article 5.6.   
7.1722  As only "SPS measures" are subject to the pr ovisions of Article 5.6, the provisions of 
Article 5.6 are not applicable to the European Co mmunities' alleged failure to consider or approve 
particular applications.  In view of this conclusi on, we need not continue our analysis of Canada's 
claim under Article 5.6. 
                                                      
1375 See also  our discussion of Canada's and Argentina's Article 5.6 claim in Section VII.D.6 above.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 712 
  
  (b) DS293 (Argentina) 
7.1723  In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton 
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97. 
(i) Product-specific measures affecting the approval  of Bt-531 cotton and RR-1445 cotton under 
Regulation 258/97 
7.1724  Argentina challenges under Article 5.6 the susp ension of consideration of, or failure to 
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted 
for "approval"
1376 under Regulation 258/97.   
7.1725  We recall that in respect of the same allege d product-specific measures Argentina presented a 
claim under Article 5.1 of the SPS Agreement .  In the context of our analysis of that claim, we have 
pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445 
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina 
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or 
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97.  As the 
existence of these product-specifi c measures has not been demonstrated, we cannot but reject 
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under 
Article 5.6 in relation to these alleged measures. 
(ii) Other product-specific measu res challenged by Argentina 
7.1726  We now turn to address the remaining eight pro duct-specific measures in respect of which the 
Panel has decided to make findings. 
7.1727  We recall that for a particular measure to be s ubject to Article 5.6 it must be an SPS measure.  
We also recall that Article 5.6 explicitly refers to "[SPS] measures to achieve the appropriate level of 
sanitary or phytosanitary protection".  Furthermore, we  recall that in the context of our earlier analysis 
of Argentina's claim under Article 5.1 we found that the type of measure Argentina is challenging in 
our view (i) does not itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is 
not a measure applied for achieving the European Communities' appropriate level of sanitary or 
phytosanitary protection.  It follows from these elements that the European Communities' alleged 
suspension of consideration of, or failure to consider , a particular application cannot be considered an 
"SPS measure" within the meaning of Article 5.6.   
7.1728  As only "SPS measures" are subject to the pr ovisions of Article 5.6, the provisions of 
Article 5.6 are not applicable to the European Comm unities' alleged suspension of consideration of, or 
failure to consider, particular applications.  In vi ew of this conclusion, we need not continue our 
analysis of Argentina's claim under Article 5.6. 
                                                      
1376 Argentina's first written submission, paras. 201-202   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 713 
  
  (c) Conclusions 
7.1729  In the light of the above, the Panel reaches the following conclusions: 
 (i) DS292 (Canada) 
 
  With reference to DS292, and having rega rd to the arguments and evidence submitted 
by Canada and the European Communities, the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.6 of the 
SPS Agreement  in respect of any of the relevant product-specific measures.      
 
 (ii) DS293 (Argentina)    With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.6 of the 
SPS Agreement  in respect of any of the product-specific measures on which the Panel 
is offering findings.  
 
5. Consistency of the product-specific measures with Article 5.5 of the SPS Agreement  
7.1730  All three Complaining Parties claim that the European Communities has acted inconsistently 
with its obligations under Article 5.5 of the SPS Agreement  in respect of the product-specific 
measures they are challenging.  
7.1731  Article 5.5 of the SPS Agreement  provides: 
"With the objective of achieving consistency in the application of the concept of 
appropriate level of sanitary or phytosanitary  protection against risks to human life or 
health, or to animal and plant life or h ealth, each Member shall avoid arbitrary or 
unjustifiable distinctions in the levels it considers to be appr opriate in different 
situations, if such distinctions result in discrimination or a disguised restriction on international trade.[....]" 
7.1732  The United States  argues that the product-specific moratoria, which, in effect, ban the 
relevant biotech products from the EC market, ar e "SPS measures" as defined in Annex A(1) of the 
SPS Agreement .  The United States argues that like th e general moratorium, the product-specific 
moratoria meet all three elements that are required to establish a violation of Article 5.5.  First , the 
European Communities has set forth distinct levels of sanitary protection in "different situations": 
products produced with biotech processi ng aids and other biotech products.  Second , those levels of 
protection exhibit differences that are "arbitrary or unjustifiable."  Third , the product-specific 
moratoria result in "discrimination or a disguised restriction on international trade." 
7.1733  Canada  puts forth its claim under Article 5.5 as an alternative to its claim under Article 5.6.  
In putting forth the Article 5.6 claim, Canada as sumed that the European Communities' appropriate 
level of protection is a "high level of protection" , but not a zero-risk level.  However, if this 
assumption is not correct and the European Communitie s' appropriate level of protection for the four 
applications of specific interest to Canada at issu e is that reflected by the product-specific marketing 
bans, namely a zero-risk level, then Canada is  of the view that the European Communities has 
violated Article 5.5 of the SPS Agreement .   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 714 
  
  7.1734  Canada argues that the failure of the European  Communities to consider or approve, without 
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in 
Annex A(1).  Canada claims that the failure to consider and approve  these applications, which Canada 
refers to as the "product-specific marketing bans" meet all three elements that are required to establish 
a violation of Article 5.5.  First , the European Communities has adopt ed different appropriate levels 
of sanitary and phytosanitary protection in "d ifferent situations" that are comparable.  Second , those 
different appropriate levels of protect ion are "arbitrary or unjustifiable."  Third , the measures 
embodying those differences, the product-specific marketing bans, result in "discrimination or a 
disguised restriction on international trade". 
7.1735  According to Canada, the "comparable" situa tions above are of the following two kinds: (i) 
the biotech products whose applications have been stalled as a result of the product-specific marketing 
bans on the one hand and the biotech products that we re approved for commercialization prior to the 
imposition of the moratorium  on the other; (ii) the biotech produc ts whose applications have been 
stalled as a result of the product-specific marketing bans  on the one hand and novel non-biotech 
products such as those produced by conventional plant breeding techniques on the other. 
7.1736  Argentina  argues that the suspension of considera tion of, or the failure to consider, the 
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the 
requirements of Article 5.5.  This is because the suspension of consideration of, or the failure to 
consider, the particular applications of interest to Argentina meets the three distinct and cumulative 
elements which are required to be demonstrated in support of a claim under Article 5.5: (i) The 
Member that imposes the measure that is the subj ect of the complaint must have adopted its own 
levels of sanitary protection against risks to human, animal or plant life or health in various different 
situations, which are comparable; (ii) these levels  of protection exhibit arbitrary or unjustifiable 
differences in the treatment of different situations; and (iii) these arbitrary or unjustifiable differences 
must result in discrimination or a restriction of international trade.  
7.1737  According to Argentina, the "comparable" s ituations are of the following two kinds: (1) 
biotech products introduced before and after the moratorium; (2) new "non-biotech" products and new 
biotech products.  
7.1738  The European Communities  argues that the delays (or failure to act within a specific 
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the 
SPS Agreement  as an issue of application  of an SPS measure and more specifically, of the approval 
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the 
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1).  As a matter 
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the 
application of another SPS measure.  As the delays of the kind alleged by the Complaining Parties do 
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities 
considers that Article 5.6 is not applicable to these delays.    
7.1739  The Panel  will analyse separately the claim pr esented by each Complaining Party.1377 
(a) DS291 (United States) 
7.1740  In relation to DS291, we recall that we have dete rmined in the context of our analysis of the 
challenge to the general EC moratorium that Arti cle 5.5 implies a reference to "SPS measures" and 
that the SPS measures at issue in Article 5.5 are those which are applied for achieving a particular 
                                                      
1377 See also  our discussion of the Complaining Parties' Article 5.5 claim in Section VII.D.7 above.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 715 
  
  level of sanitary or phytosanitary protection ( i.e., measures implementing a particular level of 
protection).  Accordingly, Article 5.5 implies that  the measure complained of is an implementing 
"SPS measure".  We recall that in the context of  our earlier analysis of the United States' product-
specific claim under Article 5.1 we found that the type of measure the United States is challenging in 
our view (i) does not itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is 
not a measure applied for achieving the European Communities' appropriate level of sanitary or 
phytosanitary protection.  It follows from these el ements that the alleged failure by the European 
Communities to consider a particular application for final approval cannot be considered an "SPS 
measure" within the meaning of Annex A(1) and Ar ticle 5.5 as interpreted by the Appellate Body.   
7.1741  As Article 5.5 in our view implies that the measures complained of are implementing "SPS 
measures", we consider that the provisions of Ar ticle 5.5 are not applicable to the European 
Communities' alleged failure to consider particular a pplications for final approval.  In view of this 
conclusion, we need not continue our analysis of the United States' claim under Article 5.5.  
(b) DS292 (Canada)  
7.1742  In relation to DS292, we recall that we have dete rmined in the context of our analysis of the 
challenge to the general EC moratorium that Arti cle 5.5 implies a reference to "SPS measures" and 
that the SPS measures at issue in Article 5.5 are those which are applied for achieving a particular 
level of sanitary or phytosanitary protection ( i.e., measures implementing a particular level of 
protection).  Accordingly, Article 5.5 implies that  the measure complained of is an implementing 
"SPS measure".  We recall that in the context of  our earlier analysis of Canada's product-specific 
claim under Article 5.1 we found that the type of m easure Canada is challengi ng in our view (i) does 
not itself constitute an SPS measure within the me aning of Annex A(1) and (ii) is not a measure 
applied for achieving the European Communities' a ppropriate level of sanitary or phytosanitary 
protection.  It follows from these elements that the alleged failure by the European Communities to 
consider or approve a particular application ca nnot be considered an "SPS measure" within the 
meaning of Annex A(1) and Article 5.5 as interpreted by the Appellate Body.   
7.1743  As Article 5.5 in our view implies that the me asure complained of is an implementing "SPS 
measure", we consider that the provisions of Ar ticle 5.5 are not applicable to the European 
Communities' alleged failure to consider or approv e particular applications.  In view of this 
conclusion, we need not continue our anal ysis of Canada's claim under Article 5.5. 
(c) DS293 (Argentina) 
7.1744  In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton 
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97. 
(i) Product-specific measures affecting the approval  of Bt-531 cotton and RR-1445 cotton under 
Regulation 258/97 
7.1745  Argentina challenges under Article 5.5 the susp ension of consideration of, or failure to 
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted 
for "approval"
1378 under Regulation 258/97.   
7.1746  We recall that in respect of the same allege d product-specific measures Argentina presented a 
claim under Article 5.1 of the SPS Agreement .  In the context of our analysis of that claim, we have 
                                                      
1378 Argentina's first written submission, paras. 201-202. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 716 
  
  pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445 
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina 
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or 
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97.  As the 
existence of these product-specifi c measures has not been demonstrated, we cannot but reject 
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under 
Article 5.5 in relation to these alleged measures. 
(ii) Other product-specific measu res challenged by Argentina 
7.1747  We now turn to address the remaining eight pro duct-specific measures in respect of which the 
Panel has decided to make findings. 
7.1748  We recall that we have determined in the cont ext of our analysis of the challenge to the 
general EC moratorium that Article 5.5 implies a reference to "SPS measures" and that the SPS 
measures at issue in Article 5.5 are those which are applied for achieving a particular level of sanitary 
or phytosanitary protection ( i.e., measures implementing a particular level of protection).  
Accordingly, Article 5.5 implies that the measure complained of is an implementing "SPS measure".  
We recall that in the context of our earlier an alysis of Argentina's product-specific claim under 
Article 5.1 we found that the type of measure Arge ntina is challenging in our view (i) does not itself 
constitute an SPS measure within the meaning of A nnex A(1) and (ii) is not a measure applied for 
achieving the European Communities' appropriate leve l of sanitary or phytosanitary protection.  It 
follows from these elements that the allege d suspension by the European Communities of 
consideration of, or the failure to consider, a par ticular application cannot be considered an "SPS 
measure" within the meaning of Annex A(1) and Ar ticle 5.5 as interpreted by the Appellate Body.   
7.1749  As Article 5.5 in our view implies that the measures complained of are implementing "SPS 
measures", we consider that the provisions of Ar ticle 5.5 are not applicable to the European 
Communities' alleged suspension of consideration of, or the failure to consider, particular 
applications.  In view of this c onclusion, we need not continue our analysis of Argentina's claim under 
Article 5.5. 
(d) Conclusions 
7.1750  In the light of the above, the Panel reaches the following conclusions: 
 (i) DS291 (United States) 
 
  With reference to DS291, and having rega rd to the arguments and evidence submitted 
by the United States and the European Co mmunities, the Panel concludes that the 
European Communities has not acted inc onsistently with its obligations under 
Article 5.5 of the SPS Agreement  in respect of any of the product-specific measures 
on which the Panel is offering findings.  
  (ii) DS292 (Canada)    With reference to DS292, and having rega rd to the arguments and evidence submitted 
by Canada and the European Communities, the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.5 of the 
SPS Agreement  in respect of any of the relevant product-specific measures.      
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 717 
  
   (iii) DS293 (Argentina) 
   With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that the European 
Communities has not acted inconsistently with  its obligations under Article 5.5 of the 
SPS Agreement  in respect of any of the product-specific measures on which the Panel 
is offering findings. 
 6. Consistency of the product-specific measures with Article 2.2 of the SPS Agreement  
7.1751  All three Complaining Parties claim that the European Communities has acted inconsistently 
with its obligations under Article 2.2 of the SPS Agreement  in respect of the product-specific 
measures they are challenging.  
7.1752  Article 2.2 of the SPS Agreement  provides: 
"Members shall ensure that any sanitary or  phytosanitary measure is applied only to 
the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained  without sufficient scientific evidence, 
except as provided for in paragraph 7 of Article 5." 
7.1753  The United States claims that, as the basic obligations  provided in Article 2.2 have been 
viewed as being specifically applied in Article 5.1, the product-specific measures – the product-
specific moratoria – are also inconsistent with Article 2.2, because they are not based on risk 
assessments as required by Article 5.1 and Annex A, paragraph 4.    
7.1754  Canada  argues that Articles 5.1 and 5.6 can be viewed as a specific application of the basic 
obligation contained in Article 2.2, and a violatio n of Articles 5.1 and 5.6 can be thus presumed to 
imply a violation of the more general provision of Artic le 2.2.  Canada is of the view that, as it has 
already demonstrated that the product-specific ma rketing bans are not "based on" risk assessments 
and are therefore inconsistent with Articles 5.1 a nd 5.6, it can therefore be presumed that the product-
specific marketing bans  also violate the requirements of Article 2.2. 
7.1755  Argentina  argues that since it has demonstrated that the suspension of consideration of, or the 
failure to consider, the particular applications of interest to Argentin a is not "based on a risk 
assessment", it has duly proven that the said suspension does not meet the requirements of Article 2.2.  
7.1756  The European Communities  argues that the delays (or failure to act within a specific 
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the 
SPS Agreement  as an issue of application  of an SPS measure and more specifically, of the approval 
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the 
Complaining Parties here thus cannot constitute an  SPS measure in the sense of Annex A(1).  As a 
matter of logic, it is clear that alleged behaviour by a Member ca nnot be an SPS measure itself as well 
as the application of another SPS measure.  As th e delays of the kind alleged by the Complaining 
Parties do not fall within the definition of an SPS measure defined by Annex A(1), the European 
Communities considers that Article 2.2 is  not applicable to these delays.    WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 718 
  
  (a) Evaluation 
7.1757  The Panel  notes that the Complaining Parties' claim under Article 2.2
1379 is in the nature of a 
consequential claim.  The Complaining Parties submit  that an inconsistency with Article 2.2 follows 
by implication from a demonstrated inconsistency with Article 5.1.  However, we have determined 
above that Article 5.1 is not applicable to  the product-specific measures as defined by the 
Complaining Parties and that, consequently, the Eu ropean Communities has no t acted inconsistently 
with its obligations under Article 5.1 in respect of  the relevant product-specific measures.  Since the 
European Communities has not acted inconsistently  with Article 5.1, and since the Complaining 
Parties' claim under Article 2.2 is premised on th e existence of a breach of Article 5.1 by the 
European Communities, the Complaining Parties' claim under Article 2.2 in our view cannot succeed. 
7.1758  In relation to DS292, we note that Canada ar gues in addition that an inconsistency with 
Article 2.2 also follows by implication from a demons trated inconsistency with Article 5.6.  However, 
we have reached the same conclu sion on Canada's claim under Artic le 5.6 as we have on Canada's 
claim under Article 5.1.  Accordingly, our reasoning in the preceding paragraph mutatis mutandis  also 
applies to Canada's argument based on the alleged inconsistency of the relevant product-specific 
measures with Article 5.6.   
7.1759  In relation to DS293, we recall, in addition, our earlier finding that Argentina has failed to 
meet its burden of demonstrating the existence of a suspension of consideration of, or failure to 
consider, Bt-531 cotton and RR-1445 cotton for approva l under Regulation 258/97.  As the existence 
of these product-specific measures has not been dem onstrated, we cannot but reject Argentina's claim 
that the European Communities has acted inconsiste ntly with its obligations under Article 2.2 in 
relation to these alleged measures. 
(b) Conclusions 
7.1760  In the light of the above, the Panel reaches the following conclusions: 
 (i) DS291 (United States) 
   With reference to DS291, and having rega rd to the arguments and evidence submitted 
by the United States and the European Co mmunities, the Panel concludes that the 
United States has failed to establish that  the European Communities has acted 
inconsistently with its obliga tions under Article 2.2 of the SPS Agreement  in respect 
of any of the product-specific measures on which the Panel is offering findings.      
  (ii) DS292 (Canada)    With reference to DS292, and having rega rd to the arguments and evidence submitted 
by Canada and the European Communities,  the Panel concludes that Canada has 
failed to establish that the European Comm unities has acted inconsistently with its 
obligations under Article 2.2 of the SPS Agreement  in respect of any of the relevant 
product-specific measures.      
 
                                                     
 
1379 See also  our discussion of the Complaining Parties' Article 2.2 claim in Section VII.D.8 above.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 719 
  
   (iii) DS293 (Argentina) 
   With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
failed to establish that the European Comm unities has acted inconsistently with its 
obligations under Article 2.2 of the SPS Agreement  in respect of any of the product-
specific measures on which the Panel is offering findings. 
 7. Consistency of the product-specific measures with Article 2.3 of the SPS Agreement  
7.1761  Canada claims that the European Communities ha s acted inconsistently with its obligations 
under Article 2.3 of the SPS Agreement  in respect of the product-specific measures it is challenging.  
7.1762  Article 2.3 of the SPS Agreement  provides: 
"Members shall ensure that their san itary and phytosanitary measures do not 
arbitrarily or unjustifiably discriminate between Members where identical or similar 
conditions prevail, including between their ow n territory and that of other Members.  
Sanitary and phytosanitary measures shall not be applied in a manner which would 
constitute a disguised restriction on international trade." 
7.1763  Canada  argues that, as the product-specific mark eting bans are inconsistent with the 
European Communities' obligations unde r Article 5.5, they are, by implication, also inconsistent with 
the European Communities' obligations under Artic le 2.3, in accordance with the jurisprudence 
established by the Appellate Body. 
7.1764  The European Communities  argues that the delays (or failure to act within a specific 
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the 
SPS Agreement  as an issue of application  of an SPS measure and more specifically, of the approval 
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the 
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1).  As a matter 
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the 
application of another SPS measure.  As the delays of the kind alleged by the Complaining Parties do 
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities 
considers that Article 2.3 is not applicable to these delays.    
(a) DS292 (Canada) 
7.1765  The Panel  notes that Canada's claim under Article 2.3
1380 is in the nature of a consequential 
claim.  Canada submits that an inconsistency with Article 2.3 follows by implication from a 
demonstrated inconsistency with Article 5.5.  Howeve r, we have determined above that Article 5.5 is 
not applicable to the product-specific measures as  defined by Canada and that, consequently, the 
European Communities has not acted inconsistently with  its obligations under Article 5.5 in respect of 
the relevant product-specific measures.  Since the European Communities has not acted inconsistently 
with Article 5.1, and since Canada's claim under Ar ticle 2.3 is premised on the existence of a breach 
of Article 5.5 by the European Communities, Cana da's claim under Article 2.3 in our view cannot 
succeed.     
                                                      
1380 See also  our discussion of Canada's Article 2.3 claim in Section VII.D.9 above.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 720 
  
  (b) Conclusion 
7.1766  In the light of the above, the Panel reaches the following conclusion: 
 (i) DS292 (Canada) 
 
  With reference to DS292, and having rega rd to the arguments and evidence submitted 
by Canada and the European Communities,  the Panel concludes that Canada has 
failed to establish that the European Comm unities has acted inconsistently with its 
obligations under Article 2.3 of the SPS Agreement in respect of any of the relevant 
product-specific measures. 
 
8. Consistency of the product-specific measures  with Article 7 and Annex B(1) of the 
SPS Agreement  
7.1767  The United States claims that the European Co mmunities has failed to publish promptly the 
existence of the product-specific measures the Un ited States is challenging and that the European 
Communities has thereby acted inconsistently with its obligations under Article  7 and Annex B(1) of 
the SPS Agreement .    
7.1768  Article 7 of the SPS Agreement  provides: 
"Members shall notify changes in their san itary or phytosanitary measures and shall 
provide information on their sanitary or ph ytosanitary measures in accordance with 
the provisions of Annex B." 
7.1769  Annex B(1) of the SPS Agreement  provides: 
"Members shall ensure that all san itary and phytosanitary regulations
1381 which have 
been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them." 
7.1770  The United States  submits that the product-specific me asures it is challenging – the product-
specific moratoria – are subject to the publication requirement in Annex B(1).  The United States argues that this is for the sa me reasons which it has provided to establish the applicability of 
Annex B(1) to the general moratorium.  The Un ited States considers that  because the European 
Communities has failed to publish, and, therefore, to publish promptly, the existence of the product-
specific moratoria, the European Communities has acted inconsisten tly with its obligations under 
Annex B(1) and Article 7. 
7.1771  The European Communities  argues that Article 7 contains procedural obligations 
(publication) regarding an SPS measure.  Thus, th e applicability of Article 7 is premised on the 
existence of an SPS measure.  SPS measur es as defined in Annex A(1) of the SPS Agreement  
presuppose the existence of an act .  The European Communities submits that the measures challenged 
by the United States are alleged failures to act within  a particular timeframe.  Thus, the United States 
is in reality complaining about delay in the comp letion of specified individual approval procedures.  
In the European Communities' view, delay of this  kind cannot constitute an SPS measure within the 
                                                     
 
1381 Sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable 
generally.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 721 
  
  meaning of Annex A(1).  Delay is a failure to act  in a timely manner.  The European Communities 
deduces from these considerations that the alleged measures are not subject to Article 7.  
7.1772  The Panel  notes that the United States alleges an inconsistency of the product-specific 
measures identified by it with Annex B(1).  The United States uses the alleged inconsistency with 
Annex B(1) as a basis for a consequential claim of inconsistency under Article 7.  Accordingly, we 
will begin our analysis with the United States' claim under Annex B(1).   
(a) "Sanitary and phytosanitary regulations" 
7.1773  As we have stated earlier, Annex B(1) appli es to "sanitary and phytosanitary regulations" 
(hereafter "SPS regulations") which have been "ado pted".  An explanatory footnote to Annex B(1) 
indicates that the term "SPS regulations" should be understood as meaning " [s]anitary and 
phytosanitary measures such as laws, decrees or or dinances which are applicable generally".   
7.1774  It follows from the foregoing that a threshold i ssue before us is whether the product-specific 
measures challenged by the United States constitute  generally applicable SPS measures which have 
been adopted.  We first examine whether the re levant product-specific measures are "generally 
applicable". 
7.1775  We recall that what the United States is cha llenging in the case of each of the product-specific 
measures is an alleged failure by the European Co mmunities to consider a specified application for 
final approval.  As is already clear from our own description of these measures, these measures are 
product-specific.  In other words, each of these m easures affects an application concerning a specific 
biotech product.  None of these measures is applicab le to all biotech products generally, or at least to 
all biotech products which fall within the scope of  the relevant EC approval procedures and require 
approval.  To that extent, there is thus a cl ear difference between the product-specific measures 
identified by the United States and the genera l moratorium on approvals, which we found was 
generally applicable inasmuch as it was applicable  to all applications wh ich were pending between 
June 1999 and August 2003.   
7.1776  In the light of this, we are unable to agree w ith the United States that each of the product-
specific measures it is challenging is a measure wh ich is "applicable generally".  As general 
applicability is a necessary definitional element of the term "SPS regulations", it is not necessary for 
us to examine whether the relevant product-speci fic measures are "SPS measures" and whether they 
have been "adopted".  We therefore find that none  of the product-specific measures challenged by the 
United States is an "SPS regulation" within the mean ing of Annex B(1).  It follows that the provisions 
of Annex B(1) are not applicable to these measures.  
7.1777  We recall that the United States seeks to establish an inconsistency with Article 7 on the basis 
of an alleged inconsistency with Annex B(1).  As we have found th at the provisions of Annex B(1) 
are not applicable to the product-specific measur es challenged by the United States, these measures 
cannot be inconsistent with these provisions.  Under the approach followed by the United States, there 
can then logically be no inconsiste ncy with Article 7 either, even assuming that Article 7 is applicable 
to these measures.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 722 
  
  (b) Conclusion  
7.1778  In the light of the above, the Panel reaches the following conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, and having rega rd to the arguments and evidence submitted 
by the United States and the European Co mmunities, the Panel concludes that the 
European Communities has not acted inc onsistently with its obligations under 
Annex B(1) and Article 7 of the SPS Agreement  in respect of any of the product-
specific measures on which the Panel is offering findings.    
 
9. Consistency of the product-specific measures  with Article 8 and Annex C(1)(a), first 
clause, of the SPS Agreement  
(a) General 
 
7.1779  All three Complaining Parties claim that the European Communities has acted inconsistently 
with its obligations under Annex C(1)(a),  first clause, and Article 8 of the SPS Agreement  in respect 
of the product-specific measures they are challenging.  
7.1780  Article 8 of the SPS Agreement  provides: 
"Members shall observe the provisions of  Annex C in the operation of control, 
inspection and approval procedures, includi ng national systems for approving the use 
of additives or for establishing tolerances fo r contaminants in foods, beverages or 
feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the 
provisions of this Agreement." 
7.1781  Annex C(1)(a), first clause, of the SPS Agreement  provides: 
"1. Members shall ensure, with respect to  any procedure to check and ensure the 
fulfilment of sanitary or phytosanitary measures, that:   
(a) such procedures are undertaken and completed without undue delay [...]." 
7.1782  The Complaining Parties seek to establish an in consistency with Article 8 on the basis of an 
inconsistency with Annex C(1)(a), first clause.  Article 8 requires, inter alia , that Members observe 
the provisions of Annex C in the operation of their approval procedures.  It follows that a failure to 
observe the provisions of Annex C(1)(a) implies a breach of Article 8.  Accordingly, should we 
conclude that the European Communities has failed to observe the provisions of Annex C(1)(a), first 
clause, in respect of any of the product-specifi c measures on which we make findings, we will also 
conclude that the European Communities has, by im plication, also acted inconsistently with the 
provisions of Article 8. 
7.1783  In relation to Annex C(1)(a), first clause, we note that we have addressed the interpretation of 
this provision in Section VII.D.11 above.
1382  We further note that in accordance with the lead-in to 
                                                      
1382 We note that like the other Parties, Argentina has addressed the meaning of Annex C(1)(a), first 
clause.  However, Argentina's relevant arguments do not lead us to an interpretation of Annex C(1)(a), first 
clause, which is different from  the one we set out earlier.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 723 
  
  Annex C(1) the provisions of Annex C(1)(a) apply "w ith respect to any procedure to check and ensure 
the fulfilment of sanitary or phytosanitary measures".  We have previously found that the procedures 
set out in Directives 90/220 and 2001/18 as well as Regulation 258/97 (to the extent it is an SPS 
measure) constitute procedures "to check and ensure  the fulfilment of sanitary or phytosanitary 
measures" within the meaning of Annex C(1) a nd, as such, are subject to the provisions of 
Annex C(1), which include those of Annex C(1)(a).  Therefore, the European Communities was and is 
required under the provisions of Annex C(1)(a) to "undertake and complete" the approval procedures 
set out in Directives 90/220 and 2001/18 as well as Regulation 258/97 (to the extent it is an SPS 
measure) "without undue delay". 
7.1784  We recall that the United States is challe nging the alleged failure by the European 
Communities to consider particular applications fo r final approval, while Ca nada is challenging the 
alleged failure by the European Communities to consid er or approve, without undue delay, particular 
applications.  We have observed in  this regard that these are essen tially challenges to the application 
by the European Communities of a particular way of  operating the relevant EC approval procedures.  
We also recall that Argentina is challenging allege d undue delays in completing the consideration and 
processing of specified applications. 
7.1785  It is clear to us, therefore, that the type of measure challenged by each of the Complaining 
Parties could in principle constitute, or lead to, a breach of the European Communities' obligations 
under Annex C(1)(a), first clause, and that this type of measure can therefore be examined in the light 
of the provisions of Annex C(1)(a), first clause.  Since the Complaining Parties seek to establish an 
inconsistency with Article 8 on the basis of an alle ged inconsistency with Anne x C(1)(a), first clause, 
this conclusion applies also to Article 8. 
(b) Deliberate Release – Applications submitted under Directive 90/220 and/or Directive 2001/18 
 
7.1786  We now begin our examination of the a pproval procedures whic h were conducted under 
Directives 90/220 and 2001/18 for the applications identified by the Complaining Parties.  Before going further, however, we should briefly address certain issues presented by the application of 
Annex C(1)(a), first clause, to approval proce dures conducted under the aforementioned Directives. 
(i) Application of Annex C(1)(a), first clause, to approval procedures begun under 
Directives 90/220 and continued under 2001/18 
7.1787  Each of the relevant approval procedures on which the Panel is making findings was begun 
under Directive 90/220 but not completed by the da te of repeal of Directive 90/220 (17 October 
2002).  Pursuant to  the provisions of Directive 2001/18, applications which were pending on the date 
of repeal of Directive 90/220 (17 October 2002) b ecame subject to Directive 2001/18 and therefore 
had to be "complemented" by the applicant in the light of the provisions of Directive 2001/18.  If the 
applicant did so by a specified deadline (17 January 2003), approval procedures were to be 
undertaken in accordance with the provisions of Directive 2001/18.
1383  For each of the approval 
procedures here at issue, approval procedures were undertaken under Directive 2001/18 after the 
applicant had complemented its application.   
7.1788  This presents the question whether approval procedures undertaken under Directive 2001/18 
in respect of applications which had previous ly been assessed under Directive 90/220 should be 
viewed as new approval procedures or as a continua tion of the approval procedures which were not 
                                                      
1383 Article 35 of Directive 2001/18.  None of the Complaining Parties questioned the WTO-
consistency of Article 35. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 724 
  
  completed under Directive 90/220.  We have alrea dy examined this question in the context of our 
analysis of the general EC moratorium on approvals.
1384  It is therefore sufficient at this juncture to 
recall our conclusion that (i) approval procedures undertaken under Directive 2001/18 in respect of 
applications which had previously been assessed under Directive 90/220 were a continuation of the 
approval procedures previously cond ucted under Directive 90/220, and th at (ii) an approval procedure 
begun under Directive 90/220 and c ontinued under Directive 2001/18 constitutes one single approval 
procedure for the purposes of Annex C(1)(a), first clause.   
7.1789  It follows from this conclusion that there is  no need, in the context of our inquiry under 
Annex C(1)(a), first clause, to distinguish betw een undue delays which may have occurred in the 
processing of an application under Directive 90/220 a nd undue delays which may have occurred when 
the procedure for the same application was continued under Directive 2001/18.  Notably, our conclusion means that a failure to observe the pr ovisions of Annex C(1)(a), first clause, can be 
established on the basis of undue delays which occurred while Directive 90/220 was in force.  
Likewise, a failure to observe the provisions of Annex C(1)(a), first clause, can also be established on 
the basis of undue delays which occurred after the en try into force of Directive 2001/18.  In either 
case, the relevant approval procedure would have be en unduly delayed, contra ry to the requirements 
of Annex C(1)(a), first clause. 
7.1790  Finally, we recall that in Section VII.D we have addressed whether the reason for the general 
EC moratorium on final approvals could have provided a justificati on for delays which might have 
occurred as a result of that moratorium.  We have also addressed whether the adoption of 
Directive 2001/18 could have justified delaying the completion of approval procedures conducted 
under Directive 90/220 so that as of October 2002 th ey would become subject to the new provisions 
of Directive 2001/18.  These earlier observations are re levant and applicable also to our examination 
of the Directive 90/220 (and 2001/18) approval procedures identified by the Complaining Parties.  
7.1791  With these general observations in mind, we now proceed with the examination of the 
individual product-specific measures complained against. 
(ii) Falcon oilseed rape (EC-62) 
7.1792  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Falcon oilseed rape has been unduly delayed.  
7.1793  The United States  initially argued that the Commission in this procedure did not submit a 
draft measure to the Regulatory Committee.  Late r, the United States argued that the Regulatory 
Committee twice failed to vote on a draft measure a nd that after the second attempt, the Commission 
never submitted a draft measure to the Regulatory Committee again.  The United States also submits 
that under the applicable EC legislation, in the absence of action by the Regulatory Committee, the 
Commission was required to submit a draft measure, wh ether favourable or negative, to the Council.  
The United States recalls in this respect that the SPS Agreement  requires that the European 
Communities make a decision without undue delay.  In this case, the Commission failed to forward a 
decision to the Council. 
7.1794  The United States submits, in add ition, that the application con cerning Falcon oilseed rape is 
one of nine applications identified by the United St ates which were stalled at the Commission level at 
the time Directive 90/220 expired and which, as of th e date of establishment of the Panel, have been 
pending for an average of six and one half years.  The United States contends in this respect that 
                                                     
 
1384 See supra , paras. 7.1535-7.1536.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 725 
  
  although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Falcon oilseed rape is undue.  The United States fu rther argues that before the European Communities 
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and 
completed in less than three years. 
7.1795  The European Communities  argues that the United States is  mistaken in saying that the 
Commission failed to submit a draft measure to the Regulatory Committee.  The Commission launched a voting procedure in J une 1999, and the Regulatory Committee met twice on the matter.  
The Regulatory Committee did not vote on 9 March 2000 because it came to the conclusion that 
further information was needed on the assessment of  the effect of the newly expressed protein on the 
biogeochemical cycle and the food chain as well as the likelihood of spreading.  The European 
Communities also states that in May 2001, the applican t modified the scope of its application, and that 
after that, the application proceeded with furt her submissions by the applicant of additional 
information. 
7.1796  The United States  responds that the only information th at could have been requested at the 
March 2000 Regulatory Committee mee ting was the information requested by Italy concerning the  
effect of the transgenic product on the biogeochemical cycles and on the food chain and on the spreading of the gene due to the possibility of crossing between the PGM and wild species.  The 
United States points out in this respect that the a pplicant responded to Italy's request on 30 November 
2000 even though, in the Untied States' view, Ital y's request was not scientifically justified. 
7.1797  The Panel  begins its analysis by addressing the US argument concerning the Commission's 
failure to re-convene the Regulatory Committee fo r a vote on the Commission's draft measure. 
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft 
measure  
7.1798  The Panel recalls that the Regulatory Comm ittee met twice, on 29 October 1999 and on 9 
March 2000, to consider a draft measure submitted by the Commission.  At neither meeting was there 
a vote on the draft measure, and the Regulatory Comm ittee did not meet again for another attempt at 
taking a vote on the application.   
7.1799  The Panel also recalls that in November  2000 the applicant provided the additional 
information which had been requested by Italy.  In  late May 2001, following a request by the lead CA 
of April 2000, the applicant clarified certain aspects of its application.  According to the lead CA, 
uncertainty as to these aspects had preven ted the Regulatory Committee from voting on the 
application in March 2000.   
7.1800  When the applicant clarified certain aspects of its application in late May 2001, it also 
submitted additional and updated information to the lead  CA.  The applicant apparently did so of its 
own motion.  It stated that this information confir med that the application was already "in line with 
the main provisions" of Directive 2001/18, which ha d been adopted in March 2001.  The applicant 
requested the lead CA to inform the other member States about the new set of documents at the next 
Regulatory Committee meeting.1385  However, the lead CA did not forward the documents to the other 
member States and the Commission because it consid ered that further clarification was necessary.1386  
                                                      
1385 Exhibit EC-62/At. 98. 
1386 Exhibit EC-62/At. 101. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 726 
  
  The applicant provided the requested clarification on 30 October 2001.
1387  Towards the end of 
November 2001, the applicant wrote to the Commi ssion, drawing atten tion to the additional 
information and indicating its desire to present th e information to the other member States at a 
meeting of the "working group on herbicide-tolera nt crops" scheduled for early December 2001.1388  
The record does not indicate whet her this meeting took place. 
7.1801  The Panel has previously stated its view that  after the March 2000 meeting of the Regulatory 
Committee, it was incumbent on the Commission to  convene another meeting with a view to 
obtaining a vote on its draft measure.  The question thus arises whether the Commission was justified 
in not convening another meeting at any point prior to  the repeal of Directive 90/220 in October 2002.   
7.1802  In approaching this question, the Panel takes note of the following elements.  To begin with, 
by the end of May 2001 the applicant had met all requests for information and clarification conveyed 
to it in the wake of the March 2000 Regulatory Comm ittee meeting.  As noted, however, at the end of 
May 2001 the applicant also provided additional a nd updated information to the lead CA.  That 
information was apparently never forwarded by th e lead CA to the other member States and the 
Commission.  Nevertheless, the record indicates that  the Commission was made aware of its existence 
in June 20011389, inquired about it in September 20011390, and also in September 2001 was told by the 
lead CA that it would be informed about when the applicant would provide the clarification sought by 
the lead CA1391.  In November 2001, the Commission was told directly by the applicant that the 
applicant had provided the clarification requested by the lead CA at the end of October 2001.   
7.1803  Furthermore, it is important to remember that the applicant provided the additional 
information, not pursuant to a requirement flowing from the provisions of Directive 90/220, but in an 
effort to convince member States to vote in favour of  approving its application.  Also, the lead CA 
had not been requested to offer an assessment of the additional information before transmitting it to 
the other member States and the Commission.  Indeed , the lead CA did not purport to undertake an 
assessment, for it merely asked the applicant for clarification and made suggestions for modifications, 
to avoid questions from other member States or to "further acceptance" by other member States.1392   
7.1804  In view of these elements, the Panel considers th at at the latest at the end of November 2001, 
after the applicant had clarified and revised the additional information first submitted in May 2001 
and directly approached the Commission in this regard, the Commission could have stepped in and 
requested the lead CA to forward the additiona l information to other member States and itself.1393  At 
least, the Commission could have done so if, as is likely, it wanted member States to have access to 
the additional information before re -convening the Regulatory Committee.   
7.1805  The Panel notes that in its November 2001 letter to the Commission, the applicant made 
known its desire to present the additional information to the other member States at a meeting of the 
                                                      
1387 Exhibit EC-62/At. 105. 
1388 Ibid. 
1389 Exhibit EC-62/At. 101. 
1390 Exhibit EC-62/At. 102 (e-mail from lead CA to applicant). 
1391 Exhibit EC-62/At. 101. 
1392 Exhibit EC-62/At. 98. 
1393 It should be noted that more than five months after the applicant had provided the clarification 
requested by the lead CA, the latter sought further modifications and additional information.  Exhibit 
EC-62/At. 106.  However, as the lead CA was not require d to make an assessment of the clarification provided 
by the applicant before transmitting the new documents to other member States and the Commission, there is no reason to consider that the Commission could not have sought the transmission of these documents to itself and 
other member States in November 2001.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 727 
  
  "working group on herbicide-tolera nt crops" scheduled for early December 2001.  The European 
Communities has not explained the mandate of the "working group on herbicide-tolerant crops".  
There is no indication that this working group played a part in the lead-up to the October 1999 and 
March 2000 meetings of the Regulatory Committee.  At any rate, the fact that the applicant wished to 
"present" the additional information to the worki ng group does not imply that the applicant did not 
want the information to be distributed to the other member States until after its presentation.  
7.1806  Had the Commission requested the lead CA to forward the additional information towards the 
end of November 2001, it could have scheduled a meeting of the Regulatory Committee for early 
2002, thus giving other member States and itself time to review the additional information.  As well, 
since Directive 90/220 was not repealed until mi d-October 2002, there was enough time for the 
Commission to adopt its draft measure in the event of a favourable vote in the Regulatory Committee and for the lead CA to give its written consent.
1394 
7.1807  In earlier findings, we observed that the Co mmission could have considered that some 
member States simply did not wish to see the Commission call another vote on its draft measure, or 
that due to the "blocking minority" of the Group of Five countries in the Regulatory Committee and 
the Council, a favourable draft measure would not ac hieve the required qualified majority, with the 
consequence that the Commission would have to co mplete the procedure by adopting its own draft 
measure.  In our view, neither c onsideration would provide a justification for the Commission's failure 
to re-convene a Regulatory Committe e meeting in early 2002.   
7.1808  Anticipated member State opposition might well ha ve been a concern for the Commission in 
view of the consequences it could have had fo r the legitimacy and accepta bility of an eventual 
decision by the Commission to approve its own draf t measure.  However, this would not have 
justified the Commission in suspending the appr oval process until it was confident that its draft 
measure would achieve a qualified majority in the Regulatory Committee.1395  Were it otherwise, the 
obligation to complete approval procedures without  undue delay would impose no real discipline as 
the Commission could then suspend approval proce dures every time it anticipates significant member 
State opposition and regardless of whether there are valid reasons for such opposition.   
7.1809  Regarding the possibility that certain member Stat es might have been reluctant to proceed to a 
vote on the Commission's draft measure, it may also be noted that the applicant strengthened the Commission's position by supplying new information which it said confirmed that its application was 
                                                     
 
1394 In earlier findings on the application concerning Falcon oilseed rape, we noted that the Commission 
could have considered that due to the "blocking minority" of the Group of Five countries in the Regulatory Committee and the Council, a favourable draft measure w ould not achieve the required qualified majority and 
that the Commission would then have to complete the procedure by adopting its draft measure.  Even assuming 
that in this scenario there was not enough time for the Commission to complete the procedure in question while 
Directive 90/220 was still in force, the Panel does not c onsider that this would have justified the Commission's 
failure to re-convene the Regulatory Committee for a vote.  The Commission would have anticipated a 
"blocking minority" on the basis of the June 1999 declaration by the Group of Five countries.  As pointed out above, there is no indication that th e June 1999 declaration was intended to bind the Governments of the Group 
of Five countries vis-à-vis other member States or the Commission.  In other words, the Group of Five countries 
retained the freedom under EC law to vote in favour of applications in the Regulatory Committee and Council.  
In the light of this, the Commission could not have legitimately invoked the June 1999 declaration as a 
justification for not re-convening th e Regulatory Committee in early 2002. 
1395 To recall, the record does not indicate, and th e European Communities di d not argue, that the 
Commission after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to 
reconsider the relevant draft measure. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 728 
  
  already in accordance with the main provisions of the new Directive 2001/18.
1396  Certainly as of the 
end of November 2001, after the applicant had clar ified and revised the additional information first 
submitted in May 2001, the Commission therefore ha d additional arguments for seeking a vote on its 
draft measure in the Regulatory Committee. 
7.1810  Based on the above considerations, the Panel is of the view that at the latest in early 2002 the 
Commission should have re-convened the Regul atory Committee meeting for a vote on the 
application concerning Falcon oilseed rape.  Accordi ngly, the Panel concludes that the time actually 
taken by the Commission to convene a further Regulatory Committee meeting – no meeting was 
convened between March 2000 and Oct ober 2002 – was unjustifiably long. 
7.1811  In addition, we recall that the United States claims that the approva l procedure concerning 
Falcon oilseed rape was unduly delayed because, due  to the moratorium, the European Communities 
failed to consider the application in question for fi nal approval.  In this respect, we note our earlier 
findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 a nd that (ii) the Commission's failure to re-
convene the Regulatory Committee for a vote on the a pplication concerning Falcon oilseed rape after 
May 2001 is consistent with the application of such  a moratorium.  In the light of this, and in the 
absence of effective rebuttal by th e European Communities, we agree with the United States that it is 
reasonable to infer that the Commission's inaction was a consequence of the general moratorium on 
approvals. 
7.1812  In view of our conclusion with regard to  the Commission's failure to re-convene the 
Regulatory Committee for a vote on a draft measure, we do not go on to examine other arguments put forward by the United States in support of its claim under Annex C(1)(a), first clause, and Article 8 of 
the SPS Agreement .   
Conclusion
 
7.1813  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to convene a further Regulat ory Committee meeting – no meeting was 
convened between March 2000 an d October 2002 – was unjustifiably long, and that it 
can reasonably be inferred from surrounding  circumstances that the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning Falcon oilseed rape for final a pproval, and that this resulted in "undue 
delay" in the completion of the relevant a pproval procedure.  Accordingly, the Panel 
concludes that in respect of the approva l procedure concerning Falcon oilseed rape, 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
 
                                                     
 
1396 It should also be recalled that in November 2000 the applicant provided the additional information 
which had been requested by Italy.  In addition, in late May 2001, following a request by the lead CA of April 
2000, the applicant clarified cert ain aspects of its application.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 729 
  
  (iii) MS8/RF3 oilseed rape (EC-63) 
7.1814  Two Complaining Parties, the United States and Canada, claim that the completion of the 
approval procedure concerning MS8/RF3 o ilseed rape has been unduly delayed. 
7.1815  The United States  initially argued that the progress of the application concerning MS8/RF3 
oilseed rape stalled when the Commission refused  to submit a draft measure to the Regulatory 
Committee as required by the approval process.  Late r, the United States argued that the Regulatory 
Committee twice failed to vote on a draft measure, and that after the second attempt the Commission 
never submitted a draft measure to the Regulatory Co mmittee again.  The United States submits that 
the resulting delay was undue. 
7.1816  The United States submits, in addition, that th e application concerning MS8/RF3 oilseed rape 
is one of nine applications identified by the Un ited States which were stalled at the Commission level 
at the time Directive 90/220 expired and which, as of  the date of establishment of the Panel, have 
been pending for an average of six and one half year s.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
MS8/RF3 oilseed rape is undue.  The United St ates further argues that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years.  
7.1817  Canada  submits that the applicant proposed and c ontinuously revised its risk management 
measures in response to concerns expressed by member States, the SCP and the Commission.  
Regardless of these attempts by the applicant, th e processing of the application has been delayed, 
which Canada believes demonstrates that the Euro pean Communities was and is intent on blocking 
the approval of this product for cultivation and is intent on imposing such onerous and unnecessary 
conditions as to make the importation of the product for processing uneconomical.   
7.1818  Canada argues that since the application went to the Community level, member States took 
approximately 12 months to put forth their objections  to the application, and after the SCP issued its 
positive opinion on the application, the European  Communities took another 12 months to address 
recommendations contained in the SCP opinion, including a monitoring plan.  Although the application was discussed at the Regulatory Committee in the summer of 1999, no vote was taken.  
Canada notes that in August 1999 the applicant proposed to voluntarily agree to meet the 
requirements of the Council's June 1999 Common Position.  On the basis of these commitments, the 
Commission invited the applicant to present its proposal to the Regulatory Committee in October 
1999.  However, while the Regulatory Committee agai n considered the proposal, it failed to hold a 
vote.  Subsequently, the applicant made further proposals as a further attempt to address concerns 
expressed by member States.  However, although the matter went yet again before the Regulatory 
Committee in March 2000, it failed to hold a vote.  
7.1819  Canada also claims that any delay in the co mpletion of the approval procedure following the 
failure of the Regulatory Committee to adopt the draft measure approving MS8/RF3 oilseed rape in 
March 2000 should be considered "undue".  Canada  notes in this regard the efforts made by the 
applicant to respond to further requests by the lead  CA.  Canada observes th at while the lead CA 
finally accepted the applicant's proposed post-marke ting monitoring plan and agricultural guidelines 
in May 2002, the European Communities provided no  information to explain the delay between May 
2002 and early January 2003, when the applicant s ubmitted a further updated do ssier under Article 35 
of Directive 2001/18. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 730 
  
  7.1820  Finally, Canada observes that more than ei ght years after the application was initially 
submitted for approval to the lead CA  in 1996 and more than six years after the SCP issued its opinion 
in May 1998, MS8/RF3 oilseed rape remains un approved either for import and processing or 
cultivation, despite reasonably available risk mana gement measures.  Canada submits that by any 
reasonable standard, the extraordinary length of tim e to process this application constitutes "undue 
delay".   
7.1821  The European Communities  argues that the United States is  mistaken in saying that the 
Commission failed to submit a draft measure to the Regulatory Committee.  The Commission 
launched a voting procedure in the Regulatory Committee in June 1999, and the Regulatory 
Committee met twice on the matter.  According to the European Communities, the Regulatory 
Committee did not vote on 9 March 2000 because Italy rai sed scientific issues re garding the effects of 
the product in question on biogeochemical cycles and on  food chains and the likelihood of spreading.  
The European Communities also stat es that in May 2001, the applicant modified the scope of its 
application, and that after that, the application pro ceeded with further submissions by the applicant of 
additional information.   
7.1822  Canada  notes that Italy's questions had already b een addressed in the application dossier and 
by the SCP.  Further, the attempts to raise c oncerns about impacts of herbicide use on farmland 
biodiversity inappropriately linked co ncerns related to herbicide use to approval of a seed variety.  
Canada notes that: 1) for all other seed varieti es, seed approval legislation is distinct from the 
pesticide approval legislation; 2) herbicide use is one of many factors that may have an impact on 
farmland biodiversity;  and 3) EC member States have actually authorized the use of glufosinate-ammonium for general use as well as for specific use on genetically modified herbicide-tolerant crops.  
Canada also counters that the European Communities fails to point out that the submission of further 
information by the applicant was necessary because the information requirements were either unclear 
or changing.   
7.1823  The Panel  begins its analysis by addressing the United States' and Canada's arguments 
concerning the Commission's failure to re-convene  the Regulatory Committee for a further meeting. 
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft 
measure  
7.1824  The Panel recalls that the Regulatory Comm ittee met twice, on 29 October 1999 and on 9 
March 2000, to consider a draft measure submitted by the Commission.  No vote was taken on the 
draft measure at either meeting and the Regulator y Committee did not meet again for another attempt 
at taking a vote on the application.   
7.1825  The record does not indicate why the Regulat ory Committee did not proceed to a vote on 
MS8/RF3 oilseed rape at the March 2000 meeting.1397  One reason may have been a request for 
information from the Italian CA.  Italy transmitte d its request to the lead CA on 14 March 2000, and 
the lead CA then forwarded it to the applicant.1398  In November 2000 the applicant provided the lead 
CA with answers to the questions raised by Ital y indicating that all the issues raised had been 
                                                      
1397 The record contains a summary of the conclusi ons for the October 1999 Regulatory Committee 
meeting, but not for the March 2000 meeting. 
1398 Exhibit EC-63/At. 87.  This fax of 14 March 2000 from the Italian CA to the lead CA specifically 
"refer[s] to the conclusion of the last meeting of the Regulatory Committee meeting".  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 731 
  
  previously addressed by the SCP as well as the update of the application provided by the applicant in 
November 1999.  This communication was also ci rculated to the other CAs and the Commission.
1399   
7.1826  It should further be noted that in June 2001 the applicant sent a letter to the lead CA which 
clarified certain aspects of the application, including its scope.  There is no indication that this 
clarification had been requested.  However, the a pplicant's letter noted that following the March 2000 
meeting of the Regulatory Committee th e clarification appeared necessary.1400  In a separate letter of 
the same date, "following the revision of Directiv e 90/220/EEC", the applicant also submitted updated 
information to the lead CA, including an update d environmental risk assessment, a post-market 
monitoring plan, agricultural guidelines, additional information regarding id entification and labelling 
and information for the public concerning the product in question.1401  The letter stated that this 
information confirmed that the application was already "in line with the main provisions" of 
Directive 2001/18, which had been adopted in March 2001.  The letter requested the lead CA to inform the other member States about the new se t of documents at the next Regulatory Committee 
meeting.
1402  There is no indication that the lead CA ev er forwarded the new documents to the other 
member States and the Commission.  A meeting of CAs was held two weeks after the applicant submitted the additional info rmation, but the Panel has no inform ation about what was discussed at 
that meeting.  It is clear from the record, however , that the lead CA confirmed receipt of the new 
documents only in July 2001.  The lead CA info rmed the applicant that it had forwarded the 
documents to the relevant scientific committee of  the Belgian Biosafety Council (hereafter the 
"BBC") for an opinion.
1403  No reason was given for why an opinion had been requested. 
7.1827  The Panel has previously stated its view that  after the March 2000 meeting of the Regulatory 
Committee, it was incumbent on the Commission to  convene another meeting with a view to 
obtaining a vote on its draft measure.  The question thus arises whether the Commission was justified in not convening another meeting at any point prior to the repeal of Directive 90/220 in October 2002. 
7.1828  In approaching this question, the Panel takes note of the following elements.  In November 
2000 the applicant had met all requests for info rmation conveyed to it following the March 2000 
Regulatory Committee.  The additional information was circulated to all CAs and the Commission in 
December 2000.  As noted, however, in June 2001 th e applicant provided additional clarification and 
updated information to the lead CA.  The record  does not indicate that the Commission was made 
aware of the existence of the June 2001 information.  At the same time, there is nothing in the record 
to suggest that the Commission was "waiting" for the June 2001 information.  
7.1829  Regarding the clarification provided by the a pplicant in June 2001, we note that if the 
Commission was not waiting for that clarification, then that clarification could not provide a justification for the Commission's failure to re-c onvene the Regulatory Committee sometime between 
December 2000 and June 2001.  On the other hand, if the Commission had been waiting for 
clarification from the applicant, it should have inqu ired with the lead CA whether the applicant had 
provided clarification.  There is no evidence that the Commission did so.   
7.1830  Regarding the updated information also provide d by the applicant in June 2001, it is 
important to remember that the applicant provided that information, not pursuant to a requirement 
flowing form the provisions of Directive 90/220, but in an effort to convince member States to vote in 
                                                     
 
1399 Exhibit EC-63/At. 89 and 90. 
1400 Exhibit EC-63/At. 92. 
1401 Exhibit EC-63/At. 91. 
1402 Ibid. 
1403 Exhibit EC-63/At. 93. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 732 
  
  favour of approving its application.  Also, the lead CA had not been requested  to offer an assessment 
of that additional information before transmitting it to the other member States and the Commission.  Notwithstanding this, the lead CA requested an opi nion of the BBC.  However, it seems that for the 
BBC, it was not obvious that an opinion was n eeded.  In November 2001, the BBC discussed the 
information in question.  According to the minutes of the internal discussion, "no opinion on the part 
of the Biosafety Advisory Council was necessary prio r to the forwarding of these documents to the 
European Commission; and in the past such additio nal information had already been sent straight to 
the Commission on several occasions."
1404  However, as this was the first time a company had 
submitted a monitoring plan, agricultural guidelines a nd public dossier, the BBC "thought it advisable 
to ask the Biosafety Advisory Council to discu ss these documents before forwarding them to the 
European Commission."1405  It was noted that in this way the relevant experts would have an 
opportunity to gain experience in the evaluation of such documents.1406      
7.1831  We are not convinced that a lead CA asse ssment of the updated information was required 
before that information could be transmitted to the Commission and the other CAs, and that the 
Commission therefore needed to  wait for the lead CA's ass essment before re-convening the 
Regulatory Committee.  Indeed, we note that in a para llel situation, a different lead CA did not find it 
necessary to make an asse ssment of additional information submi tted by an applicant to demonstrate 
that its application was already in line with the main provisions of Directive 2001/18.1407   
7.1832  In any event, in the approval procedure c oncerning MS8/RF3 oilseed rape, the applicant 
replied to the last pending question of the BBC in early May 2002.1408  The record shows no further 
developments in this approval procedure until Oc tober 2002, when Directive 90/220 was repealed.  
Thus, there is no indication that the BBC ever pr ovided its opinion on the J une 2001 information to 
the lead CA.  Even assuming that the Commission kn ew about the updated info rmation of June 2001, 
and even assuming that it was justifiable in princi ple for the Commission to let the lead CA undertake 
some assessment of the information, it remained the Commission's responsibility to seek a vote by the 
Regulatory Committee on its draft measure.  Yet even  as the date of repeal of Directive 90/220 was 
approaching, the Commission apparently did not reque st the lead CA promptly to finish its assessment 
of the updated information and to circulate it together with that information so that a further attempt at 
completing the approval procedure under Directive 90/220 could be made.1409 
7.1833  In view of these elements, we consider that if the Commission had sought the circulation of 
the additional information once the applicant had repl ied to the last pending question in May 2002, it 
should have been possible for the information to  be circulated promptly and for a Regulatory 
Committee meeting to be held in the summer of 2002 at the latest.  As Directive 90/220 was not 
repealed until mid-October 2002, we think this would have left enough time for the Commission to 
adopt its draft measure in the event of a favourable  vote in the Regulatory Committee and for the lead 
CA to give its written consent.1410   
                                                      
1404 Exhibit EC-63/At.  102. 
1405 Ibid. 
1406 Ibid. 
1407 See our earlier analysis of th e approval procedure concerning Falcon oilseed rape. 
1408 Exhibit EC-63/At.  108.  The applicant also indicated readiness to follow a suggestion by the BBC 
regarding information to the public, subject to further clarification by the BBC.  Ibid. 
1409 If the Commission did not know about the updated information submitted by the applicant in June 
2001, then the existence of that information could not provide a justification for the Commission's failure to re-
convene the Regulatory Committ ee after December 2000.   
1410 The Commission might have considered that due to the "blocking minority" of the Group of Five 
countries in the Regulatory Committee and the Council, a favourable draft measure would not achieve the  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 733 
  
  7.1834  In earlier findings, the Panel observed that the Commission could have considered that some 
member States simply did not wish to see the Commission call another vote on its draft measure, or that due to the "blocking minority" of the Group of Five countries in the Regulatory Committee and 
the Council, a favourable draft measure would not ha ve achieved the required qualified majority, with 
the consequence that the Commission would have to complete the procedure by adopting its own draft 
measure.  In the Panel's view, neither consid eration would provide a justification for the 
Commission's failure to re-convene the Regulatory Committee for a third meeting. 
7.1835  Anticipated member State opposition might well ha ve been a concern for the Commission in 
view of the consequences it could have had fo r the legitimacy and accepta bility of an eventual 
decision by the Commission to approve its own draf t measure.  However, this would not have 
justified the Commission in suspending the appr oval process until it was confident that its draft 
measure would achieve a qualified majority in the Regulatory Committee.
1411  Were it otherwise, the 
obligation to complete approval procedures without  undue delay would impose no real discipline as 
the Commission could then suspend approval proce dures every time it anticipates significant member 
State opposition and regardless of whether there are valid reasons for such opposition.   
7.1836  Regarding the possibility that certain member Stat es might have been reluctant to proceed to a 
vote on the Commission's draft measure, it should also  be noted that if th e Commission was aware of 
the existence of the updated information of June 2 001, then that information would have provided it 
with additional arguments for seeking a vote on its draft measure in the Regulatory Committee.  To 
recall, the applicant submitted the June 2001 info rmation to demonstrate that the application 
concerning MS8/RF3 was already in accordance with the main provisions of the new Directive 2001/18. 
7.1837  Based on the above considerations, the Panel is of  the view that at the very latest in the 
summer of 2002 the Commission should have re-c onvened the Regulatory Committee for a vote on 
the application concerning MS8/RF3 oilseed rape.  Accordingly, the Panel concludes that the time 
actually taken by the Commission to convene th e Regulatory Committee for a further meeting – no 
meeting was held between March 2000 and October 2002 – was unjustifiably long. 
7.1838  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning MS8/RF3 oilseed rape was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 a nd that (ii) the Commission's failure to re-
convene the Regulatory Committee for a vote on the application concerning MS8/RF3 oilseed rape 
after November 2001 is consistent with the application of such a measure.  In the light of this, and in 
                                                                                                                                                                    
 
required qualified majority and that the Commission would then have to complete the procedure by adopting its 
draft measure.  Even assuming that in this scenario there was not enough time for the Commission to complete the procedure in question while Directive 90/220 was still in  force, the Panel does not consider that this would 
have justified the Commission's failure to re-convene the Regulatory Committee for a vote.  The Commission 
would have anticipated a "blocking minority" on the basis of the June 1999 declaration by the Group of Five countries.  As pointed out above, there is no indication that the June 1999 declaration was intended to bind the 
Governments of the Group of Five countries vis-à-vis  other member States or the Commission.  In other words, 
the Group of Five countries retained the freedom under EC law to vote in favour of applications in the 
Regulatory Committee and Council.  In the light of this, the Commission could not have legitimately invoked 
the June 1999 declaration as a justification for not re-convening the Regulatory Committee.       
1411 The record does not indicate, and the European Communities did not argue, that the Commission 
after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to reconsider 
the relevant draft measure. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 734 
  
  the absence of effective rebuttal by  the European Communities, we ag ree with the United States that it 
is reasonable to infer that the Commission's inacti on was a consequence of the general moratorium on 
approvals. 
7.1839  In view of our conclusion with regard to  the Commission's failure to re-convene the 
Regulatory Committee for a vote on a draft measure, we do not go on to examine other arguments put forward by the United States and Canada in support of their claim under Annex C(1)(a), first clause, 
and Article 8 of the SPS Agreement .   
Conclusion
 
7.1840  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to convene the Regulatory Committee for a further meeting – no 
meeting was convened between March 2000 and October 2002 – was unjustifiably 
long, and that it can reasonably be inferred from surrounding circumstances that the Commission's inaction was a consequence of the general moratorium on approvals.  
Based on these findings, the Panel accepts the United States' contention that, 
consistent with the general moratorium, th e European Communities failed to consider 
the application concerning MS8/RF3 oilseed rape for final approval, and that this 
resulted in "undue delay" in the completi on of the relevant approval procedure.  
Accordingly, the Panel concludes that in respect of the approval procedure concerning MS8/RF3 oilseed rape, the Eu ropean Communities has breached its 
obligations under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement . 
 
 (ii) DS292 (Canada) 
   With reference to DS292, the Panel reca lls its finding that the time taken by the 
Commission to convene the Regulatory Committee for a further meeting – no meeting was convened between March 2000 and October 2002 – was unjustifiably 
long.  Based on this finding, the Panel accep ts Canada's contention that the European 
Communities failed to "consider or approve , without undue delay", the application 
concerning MS8/RF3 oilseed rape, and that  it consequently did not complete the 
relevant approval procedure without " undue delay".  Accordingly, the Panel 
concludes that in respect of the approva l procedure concerning MS8/RF3 oilseed 
rape, the European Communities has breached  its obligations under Annex C(1)(a), 
first clause, and Article 8 of the SPS Agreement .   
 
(iv) RR fodder beet (EC-64)   
7.1841  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning the RR fodder beet has been unduly delayed.  
7.1842  The United States  initially argued that the Commission in this procedure did not submit a 
draft measure to the Regulatory Committee.  Late r, the United States argued that the Regulatory 
Committee twice failed to vote on a draft measure a nd that after the second attempt, the Commission 
never submitted a draft measure to the Regulatory Committee again.  The United States also submits 
that under the applicable EC legislation, in the absence of action by the Regulatory Committee, the  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 735 
  
  Commission was required to submit a draft measure, wh ether favourable or negative, to the Council.  
The United States recalls in this respect that the SPS Agreement  requires that the European 
Communities make a decision without undue delay.  In this case, the Commission failed to forward a 
decision to the Council. 
7.1843  The United States submits, in addition, that th e application concerning RR fodder beet is one 
of nine applications identified by the United Stat es which were stalled at the Commission level at the 
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been 
pending for an average of six and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
RR fodder beet is undue.  The United States furthe r argues that before the European Communities 
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and 
completed in less than three years.  
7.1844  The European Communities  argues that contrary to the US argument, the Commission 
launched a voting procedure in June 1999, and th e Regulatory Committee met twice on the matter – 
first on 29 October 1999 and then on 9 March 2000.  The Regulatory Committee did not vote on 29 
October 1999 due to outstanding requests for information. 
7.1845  The United States  responds that contrary to the European Communities' assertion that there 
were outstanding requests for information, the applicants had voluntari ly provided additional 
information in an attempt to remove any possibl e remaining obstacle to a Regulatory Committee vote 
during the one and a half  years between when th e SCP issued its opinion and when the Regulatory 
Committee finally met.  The United States also notes that when the applicants attempted to get a 
resolution of this matter on 12 July 2000, stating that  they had fully addressed all objections raised by 
member States and requesting the lead CA "to info rm all member States that the application was 
complete and subject to a Community decision"
1412, the European Communities ignored, for six 
months, the applicant's request.  
7.1846  The Panel  begins its analysis by addressing the US argument concerning the Commission's 
failure to re-convene the Regulatory Committee fo r a vote on the Commission's draft measure. 
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft 
measure  
7.1847  The Panel recalls that, after the SCP issued its favourable opinion with regard to this 
application on 23 June 1998, the Regulatory Committee met twice, on 29 October 1999 and on 9 
March 2000, to consider a draft measure submitted by the Commission.  No vote was taken on the draft measure at either meeting, and the Regulator y Committee did not meet again for another attempt 
at taking a vote on the application.  
7.1848  We also recall that in July 2000 the applican t provided the additional information requested 
by the Italian CA, as well as data on molecular char acterization which were apparently generated at 
the request of the United Kingdom's CA.  The conclu sion of the July 2000 letter states that, in the 
applicant's view, all objections raised by th e CAs within the 60-day period provided for in 
Directive 90/220 had now been fully addressed.  We fu rther recall that the lead CA did not forward 
the new documents to the other CAs.  As also not ed earlier, the Commission received a copy of the 
applicant's July 2000 letter.   
                                                     
 
1412 Exhibit EC-64/At. 119. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 736 
  
  7.1849  The Panel has previously stated its view that  after the March 2000 meeting of the Regulatory 
Committee, it was incumbent on the Commission to  convene another meeting with a view to 
obtaining a vote on its draft measure.  The question thus arises whether the Commission was justified 
in not convening another meeting at any point prior to  the repeal of Directive 90/220 in October 2002.   
7.1850  In approaching this question, the Panel takes note of the following elements.  To begin with, 
by mid-July 2000 the applicant had apparently addr essed all objections raised by the CAs within the 
60-day period provided for in Directive 90/220 and c onveyed to the applicant.  That information was 
never forwarded by the lead CA to the other CAs.  However, it should be recalled in this respect that 
in February 2001 the applicant suggested to the lead  CA, in view of the "very volatile" EC regulatory 
context, that it forward the documents after the a doption of Directive 2001/18 (which came in March 
2001) and the circulation of a Commission proposal on new EC rules concerning labelling and traceability (which came in July 2001).
1413  The lead CA did not follow  the applicant's suggestion. 
7.1851  Furthermore, as noted, the Commission received a co py of the applicant's July 2000 letter.  It 
is likely that the Commission wanted the other CAs to have access to the additional information 
provided in July 2000 before re-convening the Regulat ory Committee.  Yet even  as the date of repeal 
of Directive 90/220 was approaching, the Commi ssion apparently did not request the lead CA 
promptly to circulate the additional information provided by the applicant in July 2000 so that a further attempt at completing the approval pro cedure under Directive 90/220 could be made.   
7.1852  In view of these elements, we consider that af ter July 2000, once the applicant had provided 
the additional information sought by the Italian CA, or at the latest in the summer of 2001, when the 
Commission circulated its proposal for new EC rules on labelling and traceability, the Commission 
could have re-convened the Regulatory Committe e for a vote on the application concerning RR 
fodder beet.  Directive 90/220 was not repealed un til 17 October 2002.  In our view, there was thus 
enough time for the Commission to adopt its draft meas ure in the event of a favourable vote in the 
Regulatory Committee and for the lead CA to give its written consent. 
7.1853  In earlier findings, we observed that the Co mmission could have considered that some 
member States simply did not wish to see the Commission call another vote on its draft measure, or that due to the "blocking minority" of the Group of Five countries in the Regulatory Committee and 
the Council, a favourable draft measure would not ac hieve the required qualified majority, with the 
consequence that the Commission would have to co mplete the procedure by adopting its own draft 
measure.  In our view, neither c onsideration would provide a justification for the Commission's failure 
to re-convene the Regulatory Committee for a vote pr ior to the repeal of Directive 90/220.   
7.1854  Anticipated member State opposition might well ha ve been a concern for the Commission in 
view of the consequences it could have had fo r the legitimacy and accepta bility of an eventual 
decision by the Commission to approve its own draf t measure.  However, this would not have 
justified the Commission's suspension of the appr oval process until it was confident that its draft 
measure would achieve a qualified majority in the Regulatory Committee.
1414  Were it otherwise, the 
obligation to complete approval procedures without  undue delay would impose no real discipline as 
the Commission could then suspend approval proce dures every time it anticipated significant member 
State opposition and regardless of whether there we re valid reasons for such opposition.   
                                                      
1413 Ibid. 
1414 To recall, the record does not indicate, and th e European Communities di d not argue, that the 
Commission after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to 
reconsider the relevant draft measure.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 737 
  
  7.1855  Regarding the possibility that certain member Stat es might have been reluctant to proceed to a 
vote on the Commission's draft measure, it may also be noted that the applicant strengthened the Commission's position by supplying supplementary in formation addressing objections raised by other 
CAs.   
7.1856  Based on the above considerations, the Panel is of the view that at the latest in the summer of 
2001 the Commission should have re-convened the Regulatory Committee for a vote on the 
application concerning RR fodder beet.  Accordingly, the Panel concludes that the time actually taken 
by the Commission to convene the Regulatory Co mmittee for a further meeting – no meeting was 
convened between March 2000 and Oct ober 2002 – was unjustifiably long. 
7.1857  In addition, we recall that the United States clai ms that the approval procedure concerning RR 
fodder beet was unduly delayed because, due to the moratorium, the European Communities failed to 
consider the application in question for final appr oval.  In this respect, we note our earlier findings 
that (i) a general de facto  moratorium on approvals was in e ffect in the European Communities 
between June 1999 and August 2003 and that (ii)  the Commission's failure to re-convene the 
Regulatory Committee for a vote on the applicati on concerning RR fodder beet after July 2000 is 
consistent with the application of such a moratori um.  In the light of this, and in the absence of 
effective rebuttal by the European Communities, we agree with the United States that it is reasonable 
to infer that the Commission's inaction was a con sequence of the general mo ratorium on approvals.  
7.1858  In view of our conclusion with regard to  the Commission's failure to re-convene the 
Regulatory Committee for a vote on its draft measur e, we do not go on to examine other arguments 
put forward by the United States in support of its  claim under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement .   
Conclusion
 
7.1859  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to convene the Regulatory Committee for a further meeting – no meeting was convened between March 2000 and October 2002 – was unjustifiably 
long, and that it can reasonably be inferred from surrounding circumstances that the 
Commission's inaction was a consequence of the general moratorium on approvals.  
Based on these findings, the Panel accepts the United States' contention that, 
consistent with the general moratorium, th e European Communities failed to consider 
the application concerning RR fodder beet for final approval, and that this resulted in 
"undue delay" in the completion of the rele vant approval procedure.   Accordingly, the 
Panel concludes that in respect of the approval procedure concerning RR fodder beet, 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
 
(v) Bt-531 cotton (EC-65) 
7.1860  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning Bt-531 cotton has been unduly delayed.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 738 
  
  7.1861  The United States  submits that the application concerning Bt-531 cotton under 
Directive 90/220 suffered a three-and-a-half-year peri od of inactivity by EC regulators.  From 7 May 
1999, after the launch of inter-service consultations on a draft measure to be submitted to the Council, 
until 12 February 2003, when the lead CA fina lly circulated the updated application to the 
Commission, the application was totally ignored by  the Commission and lead CA.  The United States 
considers this lengthy delay to be  unwarranted and thus undue.   
7.1862  The United States points out in this respect th at the application in question had received a 
favourable scientific assessment by the European Co mmunity's own scientific committee, the SCP.  
That certain member States objected in the Regul atory Committee does not justify the Commission's 
refusal to act on the application.  The United States submits that those objections which were 
explained in statements, notably those by Aust ria and the United Kingdom, were the subject of 
detailed scientific consideration in the SCP's positiv e opinion in July 1998.  The United States also 
notes that there is at any rate nothing to indicate that the Commission undertook any process 
whatsoever to resolve the member State concerns.  Moreover, nothing in the record indicates that the 
applicant was ever requested to submit additional information to address the member State objections, 
nor that the basis of these objections was ever even  notified to the applican t.  The United States is 
therefore of the view that the delay in questi on was not caused, as the European Communities claims, 
by a pending request to the applicant for additional information.   
7.1863  The United States notes in addition that the EC  legislative framework provides a specific 
avenue for further action where the Regulatory Co mmittee is unable to come to a decision:  the 
Commission is to forward the application to the Co uncil "without delay" for a decision.  The United 
States considers that where the European Comm unities' own legislation provides timelines, a 
suspension of the approval procedure without any sci entific justification must be considered undue 
delay.   
7.1864  The United States submits, finally, that the application concerning Bt-531 cotton is one of 
nine applications identified by the United States which were stalled at the Commission level at the 
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been 
pending for an average of six and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Bt-531 cotton is undue.  The United States also argue s that before the European Communities adopted 
its moratorium, all approval procedures under Dir ective 90/220 were undertaken and completed in 
less than three years.    
7.1865  Argentina  argues that after the Regulatory Committee in February 1999 failed to achieve a 
qualified majority in favour of approving the a pplication concerning Bt-531 cotton, the Commission 
refused to submit a draft measure to the Council until the application had to be resubmitted under 
Directive 2001/18.  Argentina submits that this was not due to any action or omission on the part of 
the applicant.  According to Ar gentina, there notably are no EC documents which specifically 
requested the applicant to provide additional informa tion.  Argentina considers that the delay which it 
says was caused by the Commission is undue.  Argentin a argues in this respect that the requirements 
of legislation not yet in force do not provide grounds for a prolonged failure to process an application.  
In particular, the application concerning Bt-531 co tton should not have been forced to start the 
procedure again under the new Directive 2001/18 when the procedure under the old Directive 90/220 had already been in progress for three years.  Furthe rmore, Argentina asserts that there is no scientific 
evidence to justify the delay after the Regulatory Committee vote.  Those member States which in the 
Regulatory Committee voted against approving Bt-531 cotton ignored the positive scientific opinion 
of the SCP of July 1998.  Moreover, Argentina c ontests the scientific validity of the statements  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 739 
  
  offered by some member States in support of thei r votes inasmuch as these statements do not refute 
the positive opinion of the SCP.
1415      
7.1866  Argentina singles out another instance of delay which it considers undue.  Argentina asserts 
that although the applicant in January 2003 submitte d an updated application in accordance with the 
requirements of Directive 2001/18, the application did not progress.  Argentina submits that, as a 
result, as of the date of its first written submi ssion – April 2004 – the application concerning Bt-531 
cotton had been inactive for an additiona l period of 1 year and 3 months.   
7.1867  Finally, Argentina submits that the total tim e consumed by the procedures under Directives 
90/220 and 2001/18, from the time the application w as first submitted until April 2004, the date of 
Argentina's first written submission, has been 7 year s and 4 months.  In Argentina's view, this delay 
can in no way be justified in the light of the dead lines stipulated in the relevant EC legislation.  
Argentina contends that the procedure under Dir ective 90/220 should normally have been completed 
within 240 days, which does not include the tim e during which a CA or the Commission may be 
awaiting additional information it may have request ed or the time needed by an EC scientific 
committee to issue an opinion ("clock-stop").  Similarly, Argentina contends that under 
Directive 2001/18, a procedure should be completed with in 285 days if no objections to the lead CA's 
initial assessment are made, and 450 days if objections  are made.  Again, this does not include the 
time spent waiting for additional information or fo r a scientific committee opinion.  Argentina asserts 
that the delay affecting the approval procedure conc erning Bt-531 cotton cannot be justified by such 
"clock-stops". 
7.1868  The European Communities  argues that the Regulatory Committee in February 1999 failed 
to reach a qualified majority because a number of member States raised scientific concerns which had not been addressed in any of the applicant's pr evious submissions.  The European Communities 
submits that long after the vote in the Regulatory Committee, on 25 July 2001, the applicant provided 
the requested additional information, and that the tr anslation of this material was not made available 
until February 2002.  According to the European Co mmunities, if there was a three-year delay after 
the Regulatory Committee vote, it was because of th e time taken by the applicant to provide the 
requested additional information.  
7.1869  Regarding the requirement contained in Article  21 of Directive 90/220 that the Commission 
"shall, without delay, submit to the Council a pro posal relating to the measures to be taken", the 
European Communities points out that in the Pharos  case
1416, the European Court of Justice examined 
an identical requirement to submit a proposal to the Council "without delay" in the context of legislation on the setting of maximum residue limits of veterinary medicinal products in foodstuffs of 
animal origin (Regulation 2377/90).  The Court stat ed that nothing in the wording of the relevant 
provision "suggests any conclusion regarding the le ngth of time indicated by the expression 'without 
delay', other than that, while a certain degree of rapi dity is required, the Commission is not required to 
act within a precise period of time nor at once, contrary to the appellant's submission".
1417  The Court 
then went on to point out that the Commission was fr ee to modify its proposal before submitting it to 
the Council and found that "if the Commission has the right to amend the proposal relating to the measures to be taken which it subm its to the Council, it must have sufficient time to consider the 
various courses of action open to it".
1418  On that basis, the Court found that the Commission, which 
had taken over eleven months before forwarding a proposal to the Council, had not breached its 
                                                      
1415 Exhibit ARG-54, p. 3. 
1416 European Court of Justice, Case C-151/98, Pharos against Commission [1999] ECR I -8157. 
1417 Ibid., para. 20. 
1418 Ibid., para. 24. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 740 
  
  obligation to act "without delay".
1419  The Court pointed to the fact that the matter with which the 
Commission was confronted was "highly complex and sensitive".1420  The Court also made it clear 
that the Commission could not be criticised for havi ng sought additional advice from an EC scientific 
committee in an effort to prevent its pr oposal from being rejected by the Council.1421  
7.1870  Concerning the case at hand, the European Communities argues th at the concerns raised by 
certain member States were all legitimate and scien tifically sound.  They could not be ignored or 
brushed off by the Commission without detailed cons ideration.  Moreover, according to the European 
Communities, in the light of the impending legisl ative changes, further reflection was necessary 
before proceeding further.  The European Comm unities submits that this is in line with the 
jurisprudence of the European Court of Justice.   
7.1871  In relation to the delay which occurred after the application was resubmitted under 
Directive 2001/18, the European Communities submits that the application contained an incomplete 
monitoring plan.  According to the European Co mmunities, the lead CA is awaiting additional 
information on the post-marketing monitoring plan that it has requested with letters of August and 
October 2003.  The European Communities argues th at it cannot be responsible for the lack of 
diligence or failings of an individual applicant.   
7.1872  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Council  
7.1873  The Panel begins its analysis by addressing the delay allegedly caused by the Commission.  
The Panel recalls that on 7 May 1999, the Commissi on launched inter-service consultations on a draft 
measure to be submitted to the Council.  But at no point prior to 17 October 2002, the date of repeal 
of Directive 90/220, did the Commission submit a dr aft measure to the Council.  The United States 
and Argentina argue that the Commission should ha ve completed its inter-service consultations and 
submitted a draft measure to the Council before October 2002.   
7.1874  It is clear that the preparation by the Commiss ion of a draft measure and its submission to the 
Council is not a process which necessarily takes more than three years.  To begin with, in other 
approval procedures, the Commission was able to prepare and submit draft measures to the Council 
within a few months, despite the fact that in tho se procedures some member States also voted against 
the Commission's draft measure in the Regulatory Committee, and that some made written statements.
1422  Moreover, as the Panel understands it, th e preparation by the Commission of a draft 
measure to be submitted to the Council is not a pr ocess that is fundamentally different from the 
preparation by the Commission of a draft measure to be submitted to the Regulatory Committee.  In 
the approval procedure here at issue, the Commissi on prepared a draft measure and launched a vote in 
                                                      
1419 The Panel notes that the judgement indicates th at during the eleven-month period, the Commission 
initially reconsidered the file for six months an d then sought a second scientific opinion.  Ibid., para. 32. 
1420 Ibid.,  para. 26. 
1421 Ibid.,  para. 27. 
1422 In the approval procedure concerning NK603 maize (Exhibit EC-76) and conducted under 
Directive 2001/18, the Commission submitted a draft m easure to the Council little over one month after the 
Regulatory Committee had failed to reach a qualified majority.  At that meeting, Austria made a statement in 
support of its negative vote.  Exhibit EC-76/At. 72.  In the approval procedure concerning Bt-11 sweet maize 
(food) and conducted under Regulation 258/97, the Commission adopted a draft measure and referred it to the Council less than two months after th e Regulatory Committee had failed to r each a qualified majority.  At that 
meeting, several member States made statements in support of their votes.  Exhibit EC-92/At. 70.     WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 741 
  
  the Regulatory Committee in less than three months.
1423  It may be inferred from these examples that 
the Commission could in principle have comp leted its task well before October 2002.   
7.1875  The issue thus becomes whether in the specifi c circumstances of this case the Commission 
could in fact have completed its task before October 2002.  The European Communities argues that 
the Commission did not need to forward a draft meas ure to the Council because the applicant took too 
long to provide information which had been request ed of it.  The European Communities notes that 
the applicant did not provide that information until 25 July 2001, and that the translation of this 
material was made available only in February 2002.  However, in its earlier analysis of the approval 
procedure in question, the Panel found that there is no evidence to suggest that the Commission was 
waiting for the additional information provided by the applicant in July 2001.  The Panel pointed out 
that even after the applicant had provided the information, the Commission did not forward a draft measure to the Council, although Directive 90/220 re mained in force for another seventeen months, 
until October 2002.  Accordingly, the information provided by the applicant in July 2001 does not 
justify the Commission's failure to forward a draft measure to the Council.         
7.1876  Another argument put forward by the Europ ean Communities to justify the Commission's 
failure to forward a draft measure to the Council relates to the fact that the Regulatory Committee 
failed to achieve the necessary qualified majority to  approve the application concerning Bt-531 cotton 
and that Austria, Sweden and the United Kingdom, in written statements supporting their votes, expressed certain concerns.  The European Co mmunities submits that these concerns were 
scientifically sound and had not been previously a ddressed by the applicant, and that they could not, 
therefore, be ignored or brushed off by the Commission without detailed consideration.   
7.1877  As no qualified majority was reached in the Re gulatory Committee, the Panel considers that, 
as a general matter, it was justifiable for the Commissi on to take some time, as part of its inter-service 
consultations, to analyse the reasons for the outco me of the vote in the Regulatory Committee and to 
determine, in the light of the results of such an an alysis, whether it would be appropriate to modify the 
Commission's draft measure before it was sent on to the Council, and if so, how.   
7.1878  The Panel recognizes that, as a matter of EC la w, the Commission's draft measure did not 
need to obtain a qualified majority in the Council to  complete the approval procedure.  If the Council 
had failed to reach a favourable qualified majority, the Commission would have had to adopt its draft 
measure and hence approve the app lication concerning Bt-531 cotton.
1424  However, it must be borne 
in mind that an EC decision to approve the ap plication concerning Bt-531 cotton would have 
authorized the applicant to market its product in al l EC member States.  In the light of this, the 
Commission had good reasons, in the Panel's view, to  seek a qualified majority in the Council as this 
would have enhanced the legitimacy and acceptability of an EC decision to approve the application 
concerning Bt-531 cotton.1425  This means that the Commission could take a reasonable period of time 
to explore ways of modifying its draft measure with a view to increasing the measure's chances of 
                                                      
1423 Exhibit EC-65/Ats. 48 and 51.  The Panel does not express a view as to whether this three-month 
period was necessary in the circumstances to complete the relevant procedural stage. 
1424 Article 21 of Directive 90/220.  If the Council had reached a qualified majority against approving 
the application, then the application would, however, have had to be rejected.   
1425 It should also be recalled that the Complaining Parties did not question the design of the approval 
procedure set out in Directive 90/220 (or its successor, Directive 2001/18), and in particular the fact that 
member States vote on applications.  If the Commission were obliged to press on immediately, preventing it from taking into account the votes a nd views expressed by member States , it would undermine the European 
Communities' ability to operate its approval procedure as designed.    WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 742 
  
  being accepted by the Council by a qualified majority.
1426  It does not mean that the Commission 
could simply wait for the majorities in the Council to change enough to allow the Commission's original draft measure to be accepted by a qua lified majority.  The obligation imposed on the 
European Communities is to complete its approval procedures without undue delay.  This obligation 
may at times require the Commission to complete an approval procedure even if it does not have the 
(qualified) majority support of the Council.        
7.1879  How much time is to be accorded to the Comm ission for the purpose of reconsidering a draft 
measure which did not obtain a qualified majori ty in the Regulatory Committee can only be 
determined in the light of the circumstances of each case.   
7.1880  Turning, then, to the circumstances of this case, the European Comm unities asserts that the 
concerns identified in the written statements by Austria, Sweden and the United Kingdom had not 
been addressed by the applicant before.  The Panel is  unable to agree with this assertion.  As pointed 
out by the United States, the concerns referred to in  the statements by the three member States were 
addressed in the SCP opinion of July 1998.
1427  At any rate, the record does not indicate that after the 
Regulatory Committee vote, the Commission or the lead CA sought additional information from the 
applicant in an effort to allay these concerns.   
7.1881  Even if it were assumed that during its in ter-service consultations the Commission was 
undertaking its own assessment of the scientific valid ity of the specific concerns expressed with a 
view to supporting its draft measure with scientific arguments1428, it is well to recall that the SCP was 
able to undertake a comprehensiv e scientific assessment of the a pplication concerning Bt-531 cotton 
in little over three months' time.1429  The Panel also notes that th e European Communities does not 
assert that the concerns raised by the member States in question presented either new or particularly 
complex scientific problems.   
7.1882  Another circumstance invoked by the European Communities is the fact that Directive 90/220 
was being revised at the time.  According to the European Communities, a period of time for 
reflection was therefore needed before proceeding fu rther.  To recall, the Commission in this case 
launched its inter-service consultations on a draf t measure to be submitted to the Council in May 
1999.  At the end of June 1999, the Council reach ed a political agreement – the Common Position – 
on the proposal to amend Directive 90/220, but Directive 2001/18, the Directive amending Directive 90/220, was not adopted until March 2001 a nd did not enter into force until October 2002.  
Thus, the Commission started its inter-service consulta tions almost three-and-a-half years before the 
entry into force of Directive 2001/18.  In the light  of this, even accepting that the Commission could 
take some time to reconsider its draft measure, the Commission's failure to forward a draft measure to the Council cannot be excused on the grounds that there was not enough time to complete the approval procedure while Directive 90/220 was still in force.
1430 
                                                      
1426 The Panel recalls once more that in other approval procedures the Commission was able to prepare 
and submit draft measures to the Council within a few months, despite the fact that in those procedures some 
member States also voted against the Commission' s draft measure in the Regulatory Committee. 
1427 Exhibit EC-65/At. 47, paras. 6.2.1 and 6.3.3-6.3.4.  The Panel notes that Sweden voted in favour of 
the Commission's draft measure and th at Sweden's statement suggests that its concerns were met.     
1428 The European Communities did not specifically assert that it was undertaking a scientific 
assessment of the concerns in question; it merely implied that the Commission embarked on a "detailed 
consideration" of these concerns.   
1429 Exhibit EC-65/Ats. 43 and 47. 
1430 In its earlier findings on the application concerning Bt-531 cotton, the Panel noted that the 
Commission had reason to believe that due to the "blocking minority" of the Group of Five countries in the  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 743 
  
  7.1883  Furthermore, the fact that some member St ates and segments of public opinion may have 
considered that Directive 90/220 was no longer ad equate and may have voi ced opposition to further 
approvals under that Directive 90/220 did not, in the Panel's view, provide a justification for the 
Commission to delay the approval procedure in ques tion until new legislation had been put in place.  
The EC legislator allowed Directive 90/220 to rema in in force and hence applicable until October 
2002.  Moreover, if the Commission saw a need to respond to concerns about perceived inadequacies 
inherent in Directive 90/220, there were other courses of action open to it.  Thus, the Commission 
could in the first instance have sought voluntary commi tments from the applicant.  Alternatively, it 
could have proposed that the applica tion be approved subject to conditions .  In this respect, it is worth 
noting that Directive 90/220 provided additional safe guards if new information on risks of Bt-531 
cotton had become available after its EC-wide approval.
1431  In such an event, a member State could, 
pursuant to Article 16, provisionally restrict or prohi bit the marketing of Bt-531 cotton.  Finally, if in 
fact the Commission had been of the view that th e risks arising from the marketing of Bt-531 cotton 
could not be adequately assessed or managed under Directive 90/220, it could arguably have sought 
the rejection of the application, subject to the ri ght of the applicant to submit the application for 
reconsideration under the revised Di rective, once it entered into force.1432 
7.1884  Based on the above considerations, the Panel is of the view that in the specific circumstances 
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure 
to the Council – no draft measure was forwar ded between June 1999 a nd October 2002 – was 
unjustifiably long.   
7.1885  Regarding DS291, we recall that the United St ates claims that the approval procedure 
concerning Bt-531 cotton was unduly delayed because, due to the moratorium, the European Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure concerning Bt-531 cotton to the Counc il is consistent with the application of such a 
moratorium.  In the light of this, and in th e absence of effective rebuttal by the European 
Communities, we agree with the United States that it is reasonable to infer that the Commission's 
inaction was a consequence of the general moratorium on approvals. 
7.1886  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Council, we do not go on to examine othe r arguments put forward by the United States and 
Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the 
SPS Agreement .   
                                                                                                                                                                    
 
Council, it would have to adopt the draft measure it submitte d to the Council.  In the Panel's view, even in this 
scenario, there was enough time for the Commission to complete the procedure in question while 
Directive 90/220 was still in force.   
1431 The Commission usually made this point in its decisions approving applications.  See, e.g., Exhibit 
ARG-35 ("[w]hereas Article 11(6) and Article 16(1) of Directive 90/220/EEC provide additional safeguards if 
new information on risks of the product becomes available"). 
1432 The fact that such a final decision might possibly have been challenged by the applicant before an 
EC court would obviously not have been a legitimate reason for not completing the approval procedure.    WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 744 
  
  Conclusions
 
7.1887  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to forward a draft measure to the Council – no draft measure was forwarded between June 1999 and October 2002 – was unjustifiably long, and that it 
can reasonably be inferred from surrounding  circumstances that the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning Bt-531 cotton for final approval, and that this resulted in "undue delay" in 
the completion of the relevant approval pro cedure.  Accordingly, the Panel concludes 
that in respect of the approval procedure concerning Bt-531 cotton, the European 
Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement . 
  (ii) DS293 (Argentina)  
  With reference to DS293, the Panel reca lls its finding that the time taken by the 
Commission to forward a draft measure to the Council – no draft measure was forwarded between June 1999 and October 2002 – was unjustifiably long.  In the light 
of this finding, the Panel concludes th at the European Communities failed to 
complete the approval procedure concerni ng Bt-531 cotton without "undue delay", 
thus breaching its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
 
(vi) RR-1445 Cotton (EC-66)  
7.1888  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning RR-1445 cotton has been unduly delayed.  
7.1889  The United States  submits that the application concerning RR-1445 cotton was delayed for 
nearly four years under Directive 90/220 by EC re gulators.  The United States submits that from 22 
February 1999, after the failure of the Regulator y Committee to reach a decision, and despite the 
launch of inter-service consultations on a draft meas ure to be submitted to the Council starting 7 May 
1999, the application was totally ignored by the Commission and lead CA until is was re-submitted 
under Directive 2001/18 on 16 January 2003.  The Unite d States considers this lengthy delay to be 
unwarranted and thus undue.   
7.1890  The United States points out in this respect th at the application in question had received a 
favourable scientific assessment by the SCP.  In th e United States' view, the fact that certain member 
States objected in the Regulatory  Committee does not justify the Commission's refusal to act on the 
application.  The United States submits that tho se objections which were explained in statements, 
notably those by Austria, Sweden and the Unite d Kingdom, were the subject of detailed scientific 
consideration in the SCP's positive opinion in July 1998.  None of the member States objecting at the Regulatory Committee stage offered any competing ri sk assessment or scientif ic evidence for their 
objections, nor did they identify any specific inadeq uacies in the SCP review.  The United States also 
notes that there is at any rate nothing to indicate that the Commission undertook any process  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 745 
  
  whatsoever to resolve the member State concerns.  Moreover, nothing in the record indicates that the 
applicant was ever requested to submit additional information to address the member State objections, 
nor that the basis of these objections was ever even  notified to the applican t.  The United States is 
therefore of the view that the delay in questi on was not caused, as the European Communities claims, 
by a pending request to the applicant for additional information.   
7.1891  The United States notes in addition that the EC  legislative framework provides a specific 
avenue for further action where the Regulatory Co mmittee is unable to come to a decision:  the 
Commission is to forward the application to the Co uncil "without delay" for a decision.  The United 
States considers that where the European Comm unities' own legislation provides timelines, a 
suspension of the approval procedure without any sci entific justification must be considered undue 
delay.   
7.1892  The United States submits, finally, that the a pplication concerning RR-1445 cotton is one of 
nine applications identified by the United States which were stalled at the Commission level at the 
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been 
pending for an average of six and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
RR-1445 cotton is undue.  The United States further argues that before the European Communities 
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and 
completed in less than three years 
7.1893  Argentina  argues that after the Regulatory Committee in February 1999 failed to achieve a 
qualified majority in favour of approving the a pplication concerning RR-1445 cotton, the Commission 
refused to submit a draft measure to the Council until the application had to be resubmitted under 
Directive 2001/18.  Argentina submits that this was not due to any action or omission on the part of 
the applicant.  According to Ar gentina, there notably are no EC documents which specifically 
requested the applicant to provide additional informa tion.  Argentina considers that the delay which it 
says was caused by the Commission is undue.  Argentin a argues in this respect that the requirements 
of legislation not yet in force do not provide grounds for a prolonged failure to process an application.  
In particular, the application concerning RR-1445 cotton should not have been forced to start the 
procedure again under the new Directive 2001/18 when the procedure under the old Directive 90/220 
had already been in progress for three years.  Furthe rmore, Argentina asserts that there is no scientific 
evidence to justify the delay after the Regulatory Committee vote.  Those member States which in the 
Regulatory Committee voted against approving  RR-1445 cotton ignored the positive scientific 
opinion of the SCP of July 1998.  Moreover, Argentina contests the scientific validity of the statements offered by some member States in support  of their votes inasmuch as these statements do 
not refute the positive opinion of the SCP.      
7.1894  Argentina identified another instance of dela y which it considers undue.  Argentina asserts 
that although the applicant in January 2003 submitte d an updated application in accordance with the 
requirements of Directive 2001/18, the application did not progress.  Argentina submits that, as a 
result, as of the date of its first written subm ission – April 2004 – the application concerning RR-1445 
cotton had been inactive for an additiona l period of 1 year and 3 months.   
7.1895  Finally, Argentina submits that the total tim e consumed by the procedures under Directives 
90/220 and 2001/18, from the time the application w as first submitted until April 2004, the date of 
Argentina's first written submission, has been 6 year s and 9 months.  In Argentina's view, this delay 
can in no way be justified in the light of the dead lines stipulated in the relevant EC legislation.  
Argentina contends that the procedure under Dir ective 90/220 should normally have been completed WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 746 
  
  within 240 days, which does not include the time during which a lead CA or the Commission may be 
awaiting additional information it may have request ed or the time needed by an EC scientific 
committee to issue an opinion.  Similarly, Argentina contends that under Directive 2001/18, a 
procedure should be completed within 285 days if no objections to the lead CA 's initial assessment are 
made, and 450 days if objections are made.  Again,  this does not include the time spent waiting for 
additional information or for a scientific committee op inion.  Argentina asserts that the delay affecting 
the approval procedure concerning RR-1445 cotton ca nnot be justified by such "clock-stops". 
7.1896  The European Communities  argues that the Regulatory Committee in February 1999 failed 
to reach a qualified majority because a number of member States raised scientific concerns which had 
not been addressed in any of the applicant's previous  submissions.  These related in particular to the 
long-term effects of herbicide tolerant crops on th e environment, to the presence of an antibiotic 
resistance marker gene, residue-limit levels and to  the effects on biodiversity of changes in crop 
management.    
7.1897  Regarding the requirement contained in Article  21 of Directive 90/220 that the Commission 
"shall, without delay, submit to the Council a pro posal relating to the measures to be taken", the 
European Communities points out that in the Pharos  case
1433, the European Court of Justice examined 
an identical requirement to submit a proposal to the Council "without delay" in the context of legislation on the setting of maximum residue limits of veterinary medicinal products in foodstuffs of 
animal origin (Regulation 2377/90).  The Court stat ed that nothing in the wording of the relevant 
provision "suggests any conclusion regarding the le ngth of time indicated by the expression 'without 
delay', other than that, while a certain degree of rapi dity is required, the Commission is not required to 
act within a precise period of time nor at once, contrary to the appellant's submission".
1434  The Court 
then went on to point out that the Commission was fr ee to modify its proposal before submitting it to 
the Council and found that "if the Commission has the right to amend the proposal relating to the 
measures to be taken which it subm its to the Council, it must have sufficient time to consider the 
various courses of action open to it".1435  On that basis, the Court found that the Commission, which 
had taken over eleven months before forwarding a proposal to the Council, had not breached its 
obligation to act "without delay".1436  The Court pointed to the fact that the matter with which the 
Commission was confronted was "highly complex and sensitive".1437  The Court also made it clear 
that the Commission could not be criticised for havi ng sought additional advice from an EC scientific 
committee in an effort to prevent its pr oposal from being rejected by the Council.1438  
7.1898  Concerning the case at hand, the European Communities argues th at the concerns raised by 
certain member States were legitimate and scientifically  sound.  They could not be ignored or brushed 
off by the Commission without detailed consider ation.  Moreover, according to the European 
Communities, in the light of the impending legisl ative changes, further reflection was necessary 
before proceeding further.  The European Comm unities submits that this is in line with the 
jurisprudence of the European Court of Justice.    
7.1899  In relation to the delay which occurred after the application was resubmitted under 
Directive 2001/18, the European Communities submits that the application contained an incomplete 
                                                      
1433 European Court of Justice, Case C-151/98, Pharos against Commission [1999] ECR I -8157. 
1434 Ibid., para. 20. 
1435 Ibid., para. 24. 
1436 The Panel notes that the judgement indicates th at during the eleven-month period, the Commission 
initially reconsidered the file for six months an d then sought a second scientific opinion.  Ibid., para. 32. 
1437 Ibid.,  para. 26. 
1438 Ibid.,  para. 27.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 747 
  
  monitoring plan.  According to the European Co mmunities, the lead CA was awaiting additional 
information on the post-marketing monitoring plan that it had requested with letters of August and 
October 2003.  The European Communities argues th at it cannot be responsible for the lack of 
diligence or failings of an individual applicant.   
7.1900  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Council
 
7.1901  The Panel recalls that, following the failure of  the Regulatory Committee to reach a decision, 
on 7 May 1999 the Commission launched inter-servi ce consultations on a draft measure to be 
submitted to the Council.  But at no point prio r to 17 October 2002, the date of repeal of 
Directive 90/220, did the Commission submit a draft measure to the Council.  The United States and Argentina argue that the Commission should have  completed its inter-service consultations and 
submitted a draft measure to the Council before October 2002.   
7.1902  It is clear that the preparation by the Commiss ion of a draft measure and its submission to the 
Council is not a process which inherently takes more  than three years.  To begin with, in other 
approval procedures, the Commission was able to prepare and submit draft measures to the Council 
within a few months, despite the fact that in tho se procedures some member States also voted against 
the Commission's draft measure in the Regulatory Committee, and that some made written statements.
1439  Moreover, as the Panel understands it, th e preparation by the Commission of a draft 
measure to be submitted to the Council is not a pr ocess that is fundamentally different from the 
preparation by the Commission of a draft measure to be submitted to the Regulatory Committee.  In 
the approval procedure here at issue, the Commissi on prepared a draft measure and launched a vote in 
the Regulatory Committee in four months after receipt of the SCP opinion.1440  It may be inferred 
from these examples that the Commission could in principle have completed its task well before October 2002.   
7.1903  The issue thus becomes whether in the specifi c circumstances of this case the Commission 
could in fact have completed its task before October 2002.  The European Communities argues that 
the Commission was not able to forward a draft m easure to the Council because the applicant took too 
long to provide information which had been request ed of it.  The European Communities notes that 
the applicant did not provide that information until 25 July 2001, and that the translation of this 
material was made available only in February 2002.  However, in our earlier analysis of the approval 
procedure concerning RR-1445 cotton, we found that there is no evidence to suggest that the 
Commission was waiting for the additional information provided by the applicant in July 2001.  We 
pointed out that even after the applicant had provided the information, the Commission did not forward a draft measure to the Council, although Directive 90/220 remained in force for another 
seventeen months.  Accordingly, the information prov ided by the applicant in July 2001 in our view 
does not justify the Commission's failure to forward a draft measure to the Council. 
                                                     
 
1439 In the approval procedure concerning NK603 maize (Exhibit EC-76) and conducted under 
Directive 2001/18, the Commission submitted a draft m easure to the Council little over one month after the 
Regulatory Committee had failed to reach a qualified majority.  At that meeting, Austria made a statement in 
support of its negative vote.  Exhibit EC-76/At. 72.  In the approval procedure concerning Bt-11 sweet maize (food) and conducted under Regulation 258/97, the Commission adopted a draft measure and referred it to the 
Council less than two months after th e Regulatory Committee had failed to r each a qualified majority.  At that 
meeting, several member States made statements in support of their votes.  Exhibit EC-92/At. 70.    
1440 Exhibit EC-66/Ats. 44 and 46.  The Panel does not express a view as to whether this four-month 
period was necessary in the circumstances to complete the relevant procedural stage. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 748 
  
  7.1904  Another argument put forward by the Europ ean Communities to justify the Commission's 
failure to forward a draft measure to the Council relates to the fact that the Regulatory Committee 
failed to achieve the necessary qualified majority  to approve the appli cation concerning RR-1445 
cotton and that Austria, Italy, Sweden and the United Kingdom, in written statements supporting their 
votes, expressed certain concerns.  The European  Communities submits that these concerns were 
scientifically sound and had not been previously a ddressed by the applicant, and that they could not, 
therefore, be ignored or brushed off by the Commission without detailed consideration.   
7.1905  As no qualified majority was reached in the Re gulatory Committee, the Panel considers that, 
as a general matter, it was justifiable for the Commissi on to take some time, as part of its inter-service 
consultations, to analyse the reasons for the outco me of the vote in the Regulatory Committee and to 
determine, in the light of the results of such an an alysis, whether it would be appropriate to modify the 
Commission's draft measure before it was sent on to the Council, and if so, how.   
7.1906  The Panel recognizes that, as a matter of EC la w, the Commission's draft measure did not 
need to obtain a qualified majority in the Council to  complete the approval procedure.  If the Council 
had failed to reach a favourable qualified majority, the Commission would have had to adopt its draft 
measure and hence approve the a pplication concerning RR-1445 cotton.
1441  H o w e v e r ,  i t  m u s t  b e  
borne in mind that an EC decision to approve the application concerning RR-1445 cotton would have 
authorized the applicant to market its product in al l EC member States.  In the light of this, the 
Commission was entitled, in the Panel's view, to try to obtain a qualified majority in the Council as 
this would have enhanced the legitimacy and acceptability of an EC decision to approve the 
application concerning RR-1445 cotton.1442  This means that the Commission could take a reasonable 
period of time to explore ways of modifying its draft measure with a view to increasing the measure's 
chances of being accepted by the Council by a qualified majority.1443  But the Commission could not 
simply wait for the majorities in the Council to change enough to allow the Commission's original 
draft measure to be accepted by a qualified majo rity.  The obligation imposed on the European 
Communities is to complete its approval procedures  without undue delay.  This obligation may at 
times require the Commission to complete an appr oval procedure even if it does not have the 
(qualified) majority support of the Council. 
7.1907  How much time is to be accorded to the Comm ission for the purpose of reconsidering a draft 
measure which did not obtain a qualified majori ty in the Regulatory Committee can only be 
determined in the light of the circumstances of each case.   
7.1908  Turning, then, to the circumstances of this case, the European Comm unities asserts that the 
concerns identified in the written statements by Austria, Italy, Sweden and the United Kingdom had 
not been addressed by the applicant before.1444  The Panel is unable to agree with this assertion.  
Austria and the United Kingdom expressed concerns arising from the antibiotic resistance marker 
                                                      
1441 Article 21 of Directive 90/220.  If the Council had reached a qualified majority against approving 
the application, then the application would, however, have had to be rejected.   
1442 It should also be recalled that the Complaining Parties did not question the design of the approval 
procedure set out in Directive 90/220 (or its successor, Directive 2001/18), and in particular the fact that 
member States vote on applications.  It is arguable that if the Panel effectively were to require the Commission 
to press on immediately, preventing it from taking into account the votes and views expressed by member 
States, it would undermine the European Communities' ability  to operate its approval procedure as designed.    
1443 The Panel recalls once more that in other approval procedures the Commission was able to prepare 
and submit draft measures to the Council within a few months, despite the fact that in those procedures some 
member States also voted against the Commissi on's draft measure in the Regulatory Committee 
1444 The statements are provided in Exhibit EC-66/At. 57.  Italy voted in favour of the Commission's 
draft measure in the Regulatory Committee.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 749 
  
  gene, which according to Dr. Squire had b een explicitly addressed in the SCP assessment.
1445  The 
concern identified by Italy was to ensure that the herbicide residues were within the limits established 
by other EC legislation, which according to the Pa nel's understanding is not a concern related to the 
safety of RR-1445 cotton per se .  Only the general concerns raised by Sweden and the United 
Kingdom regarding long-term effects of herbicid e tolerant crops on the environment were not, 
according to Dr. Andow fully addressed by the SCP with regard to RR-1445 cotton.1446  However, Dr. 
Andow indicated that the long-term experiments suggested by Sweden were not feasible and that the concerns identified could best be addressed in a monitoring plan, but that the necessity of a 
monitoring plan could not be determined from the objections as submitted.  At any rate, the record 
does not indicate that after the Regulatory Committ ee vote, the Commission or the lead CA sought 
additional information from the applicant in  an effort to allay these concerns.   
7.1909  Even if it were assumed that during its in ter-service consultations the Commission was 
undertaking its own assessment of the scientific valid ity of the specific concerns expressed with a 
view to supporting its draft measure with scientific arguments
1447, it is well to recall that the SCP was 
able to undertake a comprehensive scientific a ssessment of the application concerning RR-1445 
cotton in little over three months' time.1448  The Panel also notes that the European Communities does 
not assert that the concerns raised by the member  States in question presented either new or 
particularly complex scientific problems.   
7.1910  Another circumstance invoked by the European Communities is the fact that Directive 90/220 
was being revised at the time.  According to the European Communities, a period of time for 
reflection was therefore needed before proceeding fu rther.  To recall, the Commission in this case 
launched its inter-service consultations on a draf t measure to be submitted to the Council in May 
1999.  At the end of June 1999, the Council reach ed a political agreement – the Common Position – 
on the proposal to amend Directive 90/220, but Directive 2001/18, the Directive amending 
Directive 90/220, was not adopted until March 2001 a nd did not enter into force until October 2002.  
Thus, the Commission started its inter-service consulta tions almost three-and-a-half years before the 
entry into force of Directive 2001/18.  In the light  of this, even accepting that the Commission could 
take some time to reconsider its draft measure, the Commission's failure to forward a draft measure to the Council cannot be excused on the grounds that there was not enough time to complete the approval procedure while Directive 90/220 was still in force.
1449 
7.1911  Furthermore, the fact that some member St ates and segments of public opinion may have 
considered that Directive 90/220 was no longer ad equate and may have voi ced opposition to further 
approvals under that Directive 90/220 did not, in the Panel's view, provide a justification for the 
Commission to delay the approval procedure in ques tion until new legislation had been put in place.  
The EC legislator allowed Directive 90/220 to rema in in force and hence applicable until October 
2002.  Moreover, if the Commission saw a need to respond to concerns about perceived inadequacies 
inherent in Directive 90/220, there were other courses of action open to it.  Thus, the Commission 
                                                      
1445 Annex H, para. 468. 
1446 Annex H, paras. 443-448. 
1447 The European Communities did not specifically assert that it was undertaking a scientific 
assessment of the concerns in question; it merely implied that the Commission embarked on a "detailed 
consideration" of these concerns.   
1448 Exhibit EC-66/Ats. 40 and 43. 
1449 In its earlier findings on the application concerning RR-1445 cotton, the Panel noted that the 
Commission had reason to believe that due to the "blocking minority" of the Group of Five countries in the 
Council, it would have to adopt the draft measure it submitte d to the Council.  In the Panel's view, even in this 
scenario, there was enough time for the Commission to complete the procedure in question while 
Directive 90/220 was still in force.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 750 
  
  could in the first instance have sought voluntary commi tments from the applicant.  Alternatively, it 
could have proposed that the applica tion be approved subject to conditions .  In this respect, it is worth 
noting that Directive 90/220 provided additional saf eguards if new information on risks of RR-1445 
cotton had become available after its EC-wide approval.
1450  In such an event, a member State could, 
pursuant to Article 16 of Directive 90/220, provisi onally restrict or prohibit the marketing of RR-1445 
cotton.  Finally, if in fact the Commission had b een of the view that the risks arising from the 
marketing of RR-1445 cotton could not be adequate ly assessed or managed under Directive 90/220, it 
could arguably have sought the rejection of the a pplication, subject, perhaps, to the right of the 
applicant to submit the application for reconsidera tion under the revised Directive, once it entered into 
force.1451 
7.1912  Based on the above considerations, the Panel is of the view that in the specific circumstances 
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure 
to the Council – no draft measure was forwar ded between June 1999 a nd October 2002 – was 
unjustifiably long.   
7.1913  Regarding DS291, we recall that the United St ates claims that the approval procedure 
concerning RR-1445 cotton was unduly delayed because, due to the moratorium, the European Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure concerning RR-1445 cotton to the Council is  consistent with the application of such a 
moratorium.  In the light of this, and in th e absence of effective rebuttal by the European 
Communities, we agree with the United States that it is reasonable to infer that the Commission's 
inaction was a consequence of the general moratorium on approvals.  
7.1914  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Council, we do not go on to examine othe r arguments put forward by the United States and 
Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the 
SPS Agreement .   
Conclusions
 
7.1915  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to forward a draft measure to the Council – no draft measure was forwarded between June 1999 and October 2002 – was unjustifiably long, and that it 
can reasonably be inferred from surrounding  circumstances that the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning RR-1445 cotton for final approval, a nd that this resulted in "undue delay" 
                                                     
 
1450 The Commission usually made this point in its decisions approving applications.  See, e.g., Exhibit 
ARG-35 ("[w]hereas Article 11(6) and Article 16(1) of Directive 90/220/EEC provide additional safeguards if 
new information on risks of the product becomes available"). 
1451 The fact that such a final decision might possibly have been challenged by the applicant before an 
EC court would obviously not have been a legitimate reason for not completing the approval procedure.     WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 751 
  
  in the completion of the relevant approva l procedure.  Accordingly, the Panel 
concludes that in respect of the appr oval procedure concerning RR-1445 cotton, the 
European Communities has breached its ob ligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
  (ii) DS293 (Argentina)    With reference to DS293, the Panel reca lls its finding that the time taken by the 
Commission to forward a draft measure to the Council – no draft measure was 
forwarded between June 1999 and October 2002 – was unjustifiably long.  In the light 
of this finding, the Panel concludes th at the European Communities failed to 
complete the approval procedure concerni ng RR-1445 cotton without "undue delay", 
thus breaching its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
 
(vii) Transgenic potato (EC-67) 
7.1916  Only one Complaining Party, the United States, claims that the completion of the approval 
procedure concerning the Transgenic potato has been unduly delayed.  
7.1917  The United States  argues that after the Transgenic potato received a favourable opinion from 
the SCP, the Commission failed to submit a draft measure to the Regulatory Committee, with the 
consequence that the considerati on of this application was susp ended until the application was 
resubmitted under Directive 2001/18.   
7.1918  The United States submits, in addition, that th e application concerning the Transgenic potato 
is one of nine applications identified by the Un ited States which were stalled at the Commission level 
at the time Directive 90/220 expired and which, as of  the date of establishment of the Panel, have 
been pending for an average of six and one half year s.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
the Transgenic potato is excessive and unjustifie d and, hence, undue.  The United States further 
argues that before the European  Communities adopted its moratorium, all approval procedures under 
Directive 90/220 were undertaken and co mpleted in less than three years. 
7.1919  The European Communities  points out that the SCP in this procedure took more than three 
and a half years to assess the Transgenic potato.  The European Communities submits that when the 
SCP issued its opinion in July 2002, Directive 2001/18  was about to enter into force and it was clear 
that the application had to be updated in the light of the new Directive.   
7.1920  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Regulatory Committee
 
7.1921  The Panel recalls that the SCP issued a favourable opinion on 18 July 2002.  Following the 
issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory Committee.  In fact, it seems that unlike in other approval procedures
1452, the Commission in this 
procedure did not even launch inter-service cons ultations on a draft measure.  In October 2002, 
                                                      
1452 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 752 
  
  Directive 90/220 was repealed.  The United States argues that the Commission should have submitted 
a draft measure to the Regulatory Committee before October 2002.   
7.1922  The preparation by the Commission of a draft measure and its submission to the Regulatory 
Committee is not a process which inherently takes very long.  In some approval procedures, the 
Commission was able to prepare and submit draft measures to the Regulatory Committee within a matter of a few months.  For example, in the procedure concerning Bt-531 cotton, the Commission prepared a draft measure and launched a vote in th e Regulatory Committee in slightly less than three 
months.
1453  Likewise, in the procedure concerning NK603 maize, the Regulatory Committee voted on 
the application a little less than three months after EFSA issued its opinion.1454   
7.1923  In the case of the approval procedure concerni ng the Transgenic potato, the SCP issued its 
opinion almost exactly three months before Dir ective 90/220 was repealed.  The Panel understands 
the European Communities to argue that in these circumstances, the Commission did not need to 
submit a draft measure to the Regulatory Committee.  This argument presents the issue whether the 
Commission could justifiably have reached the conclu sion that three months would be insufficient to 
approve the application concerning the Transgenic potato.     
7.1924  In its earlier findings, the Panel found that before  the Transgenic potato could be approved, a 
number of procedural steps remained to be unde rtaken and completed.  The Commission had to 
prepare a draft measure and submit it to the Regulat ory Committee;  the Regulatory Committee had to 
meet and vote on the draft measure;  in the event of a favourable vote in the Regulatory Committee, 
the Commission had to adopt its draft measure;  and finally, the lead CA had to give its written 
consent so that the product could be placed on the market.  Directive 90/220 does not stipulate specific deadlines for any of  these procedural steps. 
7.1925  As pointed out above, the record shows that  in one particular approval procedure, the 
Commission was able to obtain a Regulatory Committee vote less than three months after EFSA 
issued its opinion.  If in the approval procedure concerning the Transgenic potato the Commission had 
proceeded with a sense of urgency, it might thus have succeeded in obtaining a Regulatory Committee 
vote in slightly less than three months.
1455  If the Commission's draft measure had achieved a qualified 
majority, the approval procedure woul d then have had to be completed within a matter of a few days.   
7.1926  The record does not provide confirmation that th is would have been possible.  Regarding the 
adoption by the Commission of its own draft measure , the approval procedure concerning Bt-11 sweet 
maize is of interest, although that procedure was conducted under Regulati on 258/97.  In that 
procedure, the Commission took close to a month to adopt its own draft measure after the Council 
failed to achieve a qualified majority.1456  Regarding the written consent to be given by the lead CA, 
the Panel finds informative the provisions of Ar ticle 18(2) of Directive 2001/18 according to which 
the lead CA must give its written consent, transm it it to the applicant and inform the other member 
States and the Commission thereof "within 30 days  following the publication or notification of the 
[Commission's] decision [to adopt its draft measure]".  While, as noted, Directive 90/220 stipulates no such deadline, the aforementioned steps were also to be completed under that Directive.
1457  I t  i s  
                                                      
1453 The Commission launched inter-service consultations on 4 September 1998 and launched a vote in 
the Regulatory Committee on 26 November 1998.  Exhibit EC-65/Ats. 48 and 51.     
1454 EFSA issued its opinion on 25 November 2003 and the Regulatory Committee voted on the 
Commission's draft measure on 18 February 2004.  Exhibit EC-76/Ats.  70 and 72.     
1455 The United States has submitted no evidence or argument to show that the Commission could have 
completed this task in substantially less time. 
1456 Exhibit EC-92/At. 81. 
1457 Article 13(4) of Directive 90/220.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 753 
  
  reasonable to infer from the thirty-day deadline set out  in Article 18(2) that the relevant steps could 
not invariably be completed in just a few days .  Notwithstanding the foregoing, it may be assumed 
that if both the Commission and the lead CA had proceeded on an urgency basis in view of the 
exceptional circumstance of the imminent repeal of  Directive 90/220, they might well have been able 
to complete their respective procedural steps in l ess than a month each.  However, the evidence before 
the Panel is insufficient to support the conclusion th at the procedural steps to be completed by the 
Commission and the lead CA should altogeth er have taken no more than a few days. 
7.1927  In conclusion, based on the evidence on the r ecord, the Panel is not convinced that the 
approval procedure concerning the Transgenic potato could have been completed in the three-month 
period preceding the date of repeal of Directive 90/220, and that the Commission should therefore have launched inter-service cons ultations on a draft measure to be submitted to the Regulatory 
Committee.  Accordingly, the Panel finds that it h as not been established that the time actually taken 
by the Commission to prepare and forward a draft measure – no draft measure was prepared and 
forwarded between July 2002 and Octo ber 2002 – was unjustifiably long.   
Total amount of time taken since submission of application
 
7.1928  The United States also puts forward the argument that the total amount of time during which 
the application concerning the Transgenic potato w as pending is excessive and unjustified and, hence, 
undue.  The application concerning the Transgenic  potato was first submitted for approval under 
Directive 90/220 in August 1996.  This means that as of the end of August 2003, the approval 
procedure had been pending for more than seven years. 
7.1929  The Panel agrees with the United St ates that, in absolute terms, this is a long period of time.  
However, the mere identification of the total am ount of time during which an application has been 
pending does not demonstrate, in and of itself, that the time taken was unjustifiably long.  Indeed, certain delays might be attributable, not to the Eu ropean Communities, but to  the applicant.  Other 
delays might be attributable to the European Commun ities, but they might be justifiable.  In the case 
of applications which were submitted under Direct ive 90/220 – and the application concerning the 
Transgenic potato is one of these – it must also be  remembered that in accordance with Article 35 of 
Directive 2001/18, applications submitted under Dir ective 90/220, but not approved by October 2002 
became subject to Directive 2002/18 and had to be re-assessed by the lead CA.  As a necessary 
consequence, applications which had progressed to  an advanced stage in the approval process under 
Directive 90/220 and then were resubmitted to th e lead CA under Directive 2001/18 were pending for 
long periods of time.  Yet despite the fact that Article 35 of Directive 2001/18 resulted in certain 
approval procedures – including that concerning th e Transgenic potato – being delayed, the United 
States did not question the provisions of Article 35.  In these circumstances, it would be incongruous 
not to take account of the fact that some of the to tal time taken to assess a relevant application was a 
direct consequence of the operation of Article 35. 
7.1930  Moreover, even if the United States were corr ect in asserting that before there was an EC 
moratorium, approval procedures used to be completed in less than three years, it must be remembered that the European Communities assesses applications on a case-by-case basis.  Thus, the 
fact that the approval procedure concerning the Tr ansgenic potato was not completed in less than WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 754 
  
  three years in our view does not demonstrate that it was not justifiable for the European Communities 
to take more time to process the appli cation concerning the Transgenic potato.
1458   
7.1931  The United States further argues that in the light of the acknowledgement by EC officials of 
the existence of a moratorium on approvals, the fact that the application in question had been pending 
for more than seven years demonstrates the existenc e of undue delay.  We recall in this respect our 
finding that the record supports the conclusi on that the European Communities applied a de facto  
moratorium on approvals as of June 1999.  At that  time, the application concerning the Transgenic 
potato had already been pending for more than two years and ten months.  Thus, some of the total 
time taken cannot be explained by the moratorium .  Moreover, the mere fact that a general 
moratorium was in effect does not necessarily imply that a particular application was affected by it.  The United States itself has repeatedly stated that "the moratorium was a decision by the EC not to 
move products to a final decision in the approval process" and that "certain progress in the process, 
short of a final decision, is not the least bit in consistent with a morato rium on final approvals".
1459  
Therefore, by itself, the fact that a moratorium  on approvals was in eff ect between June 1999 and 
August 2003 is not sufficient to demonstrate that  the period of time during which the application 
concerning the Transgenic potato was pending as of August 2003 reflects a failure on the part of the lead CA to complete the relevant appr oval procedure  without undue delay.  
7.1932  Accordingly, the Panel is unable to accept the United States' assertion that the total period of 
time during which the application concerning the Transgenic potato had been pending as of August 
2003 demonstrates that the time taken was unjustifiably long. 
Conclusion
 
7.1933  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that it has not been established 
that the time taken by the Commission to pr epare and forward a draft measure to the 
Regulatory Committee once the SCP had issued its opinion – no draft measure was forwarded between late July 2002 and Oct ober 2002 – was unjustifiably long, or that 
the total amount of time taken by the Eu ropean Communities up to August 2003 was 
unjustifiably long.  Based on these findings , the Panel is unable to accept the United 
States' contention that, consistent with the general moratorium, the European 
Communities failed to consider the applica tion concerning the Transgenic potato for 
final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning the Transgenic potato, the United States has failed to 
establish that the European Communiti es has breached its obligations under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement . 
 
                                                     
 
1458 It is worth recalling, more generally, that the approval procedures which were completed before 
there was a moratorium on approvals were not affected  by the special circumstance that Directive 90/220 was 
repealed in 2002.    
1459 See, e.g., US second written submission, para. 51 (emphasis in original).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 755 
  
  (viii) Liberator oilseed rape (EC-68) 
7.1934  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Liberator oilseed rape has been unduly delayed.  
7.1935  The United States  argues that after Liberator oilseed rape received a favourable opinion from 
the SCP the Commission failed to submit a draft m easure to the Regulatory Committee.  The United 
States notes that this resulted in a two-year de lay, since no action was taken on the application until 
November 2002 when the applicant was requested to pr ovide an update in light of the entry into force 
of Directive 2001/18.  The United States submits that there is no indication of any problem with the 
application during the two-year gap, nor of any a dditional information needed for final approval.  
According to the United States, the tw o-year delay was therefore undue.   
7.1936  The United States submits, in addition, that th e application concerning Liberator oilseed rape 
is one of nine applications identified by the Un ited States which were stalled at the Commission level 
at the time Directive 90/220 expired and which, as of  the date of establishment of the Panel, have 
been pending for an average of six and one half year s.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Liberator oilseed rape is undue .  The United States further argu es that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.1937  The European Communities  argues that the SCP opinion on Liberator oilseed rape 
recommended "an agreed code of practice for field management of the particular modified crop 
involving the active participation of the applicant to promote best practice by farmers".
1460  T h e  
European Communities submits that contrary to what it had done in the parallel dossier on Falcon oilseed rape, the applicant did not present any propo sal for a code of practice following the opinion of 
the SCP and that it did not manifest itself with the lead CA at all until the lead CA in November 2002 
sent the applicant a letter reminding it of the need to up-date the application by January 2003.  The 
European Communities submits that it cannot be held responsible for delays that are caused by the lack of diligence or the failings of an applicant.  
7.1938  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Regulatory Committee  
 
7.1939  The Panel recalls that the SCP issued a fa vourable opinion on 30 November 2000.  Following 
the issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory 
Committee until Directive 90/220 was repealed in October 2002.  After the repeal of 
Directive 90/220, on 5 November 2002, the lead CA c ontacted the applicant to remind it of the need 
to update the application so that it could be fu rther considered under Directive 2001/18.  The United 
States argues that the Commission should have submitted a draft measure to the Regulatory 
Committee before October 2002.   
7.1940  The preparation by the Commission of a draft measure and its submission to the Regulatory 
Committee is not a process which i nherently takes more than twenty-two months.  In other approval 
procedures, the Commission was able to prepare and submit draft measures to the Regulatory Committee within a matter of a few months.  For exam ple, in the procedure concerning Bt-531 cotton, 
                                                     
 
1460 Exhibit EC-68/At. 88. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 756 
  
  the Commission prepared a draft measure and launc hed a vote in the Regulatory Committee in less 
than three months.
1461  Likewise, in the procedure concerning NK603 maize, the Regulatory 
Committee voted on the application less than th ree months after EFSA issued its opinion.1462  It may 
be inferred from these examples that the Commi ssion could in principle have submitted a draft 
measure to the Regulatory Committee well before October 2002.   
7.1941  The fact that the Commission could in prin ciple have submitted a draft measure to the 
Regulatory Committee before October 2002 does not necessarily mean that the Commission could have done so in the specific circumstances of this case.  The European Communities essentially 
asserts that its failure to do so is justified in view of the applicant's failure to  present a code of practice 
for the field management of Liberator oilseed rape once the SCP had issued its opinion.  However, in 
its earlier analysis of the approval procedure in question, the Panel found that it was not persuaded 
that the applicant was supposed to present a proposal for a code of practice, nor that the Commission 
failed to submit a draft measure to the Regulator y Committee because it was waiting for the applicant 
to propose a code of practice.  The Panel further f ound that, in any event, the Commission in this case 
did not launch inter-service consultations on a dr aft measure to be submitted to the Regulatory 
Committee, and that the fact that the applicant di d not present a proposal was not an obstacle to the 
Commission launching such consultations.
1463  Accordingly, the Panel is unable to agree with the 
European Communities that the a pplicant's failure to present a code of practice justified the 
Commission's failure to forward a draft measure to the Regulatory Committee before October 2002. 
7.1942  Separately, it should be noted that the SCP opinion in this procedure dates from 
November 2000.  Directive 90/220 was not repealed until almost two years later.  There was thus 
enough time for the Commission to launch and co mplete inter-service consultations on a draft 
measure to be submitted to the Regulatory Commi ttee and for the Commission to adopt its draft 
measure in the event of a favourable vote in the Re gulatory Committee.  In the Panel's assessment, the 
Commission's inaction cannot, therefore, be excu sed on the grounds that the approval procedure 
concerning Liberator oilseed rape could not be co mpleted while Directive 90/220 was still in force. 
7.1943  In its earlier findings on the application concer ning Liberator oilseed rape, the Panel noted 
that the Commission could have considered that due to the "blocking minority" of the Group of Five 
countries in the Regulatory Committee and the Council,  a favourable draft measure would not achieve 
the required qualified majority and that the Commiss ion would then have to complete the procedure 
by adopting its draft measure.  In the Panel's view , even in this scenario, there was enough time for 
the Commission to complete the procedure in questi on while Directive 90/220 was still in force.  But 
even if it the Commission considered it doubtfu l that there would be enough time in view of 
anticipated member State opposition, the Panel does not  consider that this would have justified the 
Commission's failure to forward a draft measure  to the Regulatory Committee.  The Commission 
would have anticipated a "blocking minority" on th e basis of the June 1999 declaration by the Group 
of Five countries.  As pointed out above, there is  no indication that the June 1999 declaration was 
intended to legally bind the Governments of the Group of Five countries vis-à-vis  other member 
States or the Commission.  In other words, the Gro up of Five countries retained the freedom under EC 
law to vote in favour of applications in the Regul atory Committee and Council.  In the light of this, 
we think the Commission could not have legiti mately invoked the June 1999 declaration as a 
justification for not submitting a draft measure to the Regulatory Committee prior to October 2002. 
                                                      
1461 Exhibit EC-65/Ats. 48 and 51.   
1462 Exhibit EC-76/Ats.  70 and 72.     
1463 See supra , para. 7.687.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 757 
  
  7.1944  Based on the above considerations, the Panel is of the view that, in the specific circumstances 
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure 
to the Regulatory Committee – no draft measure was forwarded between late November 2000 and 
October 2002 – was unjustifiably long.   
7.1945  In addition, we recall that the United States claims that the approva l procedure concerning 
Liberator oilseed rape was unduly delayed becau se, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent 
with the application of such a moratorium.  In the li ght of this, and in the absence of effective rebuttal 
by the European Communities, we ag ree with the United States that it is reasonable to infer that the 
Commission's inaction was a consequence of  the general moratorium on approvals. 
7.1946  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United 
States in support of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .  
Conclusion
 
7.1947  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to prepare and forward a draft measure to the Regulatory Committee once the SCP had issued its opinion – no draft measure was forwarded between late November 2000 and October 2002 – was unjustifiably long, and that it can 
reasonably be inferred from surrounding circumstances that  the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning Liberator oilseed rape for final approval, and that th is resulted in "undue 
delay" in the completion of the relevant a pproval procedure.  Accordingly, the Panel 
concludes that in respect of the approval procedure concerning Liberator oilseed rape, 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
 
(ix) Bt-11 maize (EC-69) 
7.1948  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Bt-11 maize (EC-69) has been unduly delayed.  
7.1949  The United States  argues that after the application concerning Bt-11 maize (EC-69) received 
a favourable opinion from the SCP in November 2000, the Commission failed to submit a draft measure to the Regulatory Committee.  The United States notes that, under the EC approval system, the next step after the SCP favourable opinion should have been to submit the application for approval 
by the Regulatory Committee.  According to the United States, however, there was no action on the 
application for two years after the SCP opinion and instead the next entry in the chronology provided by the European Communities is an "evaluation of updates by the lead CA" in October 2002, which is WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 758 
  
  unexplained and unsupported by any exhibit or attachment.  According to the United States, the 
lengthy delay after the SCP opinion was issued pr ovides compelling evidence of the existence of a 
general moratorium. 
7.1950  The United States submits, in addition, that the application concerning Bt-11 maize (EC-69) 
maize is one of nine applications identified by  the United States which were stalled at the 
Commission level at the time Directive 90/220 expired and which, as of the date of establishment of 
the Panel, have been pending for an average of six and one half years.  The United States contends in 
this respect that although time alone is not dispos itive, in the light of the acknowledgement by EC 
officials of the existence of a moratorium on approvals, this delay in  completing the approval 
procedure concerning Bt-11 maize (EC-69) is undue.  The United States further argues that before the 
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.1951  The European Communities  argues that, after the SCP opinion, further discussions were 
held between the lead CA, the applicant and the Commission, and they went on until well into 2002.  
The European Communities notes in this respect that the SCP recommended a monitoring plan, and 
that the issue of the monitoring plan remained unsettled.  The European Communities further points 
out that in May 2002 the applicant submitted additional information, including supplementary 
sequence information on the molecu lar characterization of the Bt-11 line, taking into account the 
provisions of the new Directive, inter alia  on monitoring, traceability and labelling.   
7.1952  The United States  responds that the monitoring plan referred to in the SCP opinion is an 
"Insect Resistance Management" (IRM) plan, and th at the SCP never recommended any changes to 
the applicant's proposed IRM plan.  The United St ates also notes that the only other mention of 
monitoring was with respect to changes in field popul ations of non-target insects, but that the SCP did 
not request a monitoring plan on non-target insect s, or note any deficiency in the application.  
Moreover, the United States argues that nothing in the record indicates that EC regulators ever 
approached the applicant either to identify a probl em or to request additions to the application.  
7.1953  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Regulatory Committee
 
7.1954  The Panel recalls that in the approval pro cedure concerning Bt-11 maize (EC-69), the SCP 
issued a favourable opinion on 30 November 2000.  Following the issuance of the SCP opinion, the 
Commission did not submit a draft measure to the Regulatory Committee.  In October 2002, 
Directive 90/220 was repealed.  The United States argues that the Commission should have submitted 
a draft measure to the Regulatory Committee before October 2002.   
7.1955  The preparation by the Commission of a draft measure and its submission to the Regulatory 
Committee is not a process which i nherently takes more than twenty-two months.  In other approval 
procedures, the Commission was able to prepare and submit draft measures to the Regulatory 
Committee within a matter of a few months.  For exam ple, in the procedure concerning Bt-531 cotton, 
the Commission prepared a draft measure and launc hed a vote in the Regulatory Committee in less 
than three months.1464  Likewise, in the procedure concerning NK603 maize, the Regulatory 
Committee voted on the application less than th ree months after EFSA issued its opinion.1465  It may 
                                                      
1464 Exhibit EC-65/Ats. 48 and 51.   
1465 Exhibits EC-76/At. 70-72.      WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 759 
  
  be inferred from these examples that the Commi ssion could in principle have submitted a draft 
measure to the Regulatory Committee well before October 2002.   
7.1956  The fact that the Commission could in prin ciple have submitted a draft measure to the 
Regulatory Committee before October 2002 does not necessarily mean that the Commission could 
have done so in the specific circumstances of this case.  The Panel understands the European 
Communities to assert that the Commission did not send a draft measure to the Regulatory Committee 
because, after the SCP opinion, the lead CA, the a pplicant and the Commission continued discussions 
on a monitoring plan well into 2002.  The Panel al so understands the European Communities to assert 
that the applicant submitted additional information in  May 2002, just before the new Directive entered 
into force.  
7.1957  Regarding the monitoring plan, we stated in ear lier findings on this approval procedure that 
we are not persuaded by the European Communitie s' assertion that the Commission did not submit a 
draft measure to the Regulatory Committee because  the SCP recommended a monitoring plan and the 
issue remained unsettled.  We further found that, in  any event, the Commission in this case did not 
launch inter-service consultations on a draft measure  to be submitted to the Regulatory Committee, 
and that the fact that the SCP stated that monito ring should be carried out was not an obstacle to the 
Commission launching inter-service consultations on a draft measure.  Accordingly, we are unable to 
agree with the European Communities that the f act that the SCP recommended a monitoring plan 
justified the Commission's failure to forward a draft measure to the Regulatory Committee before 
October 2002.    
7.1958  Regarding the additional inform ation submitted by the applic ant in May 2002, we have 
already observed earlier that this information was apparently voluntarily submitted with a view to 
updating the application in anticipation of the entry into force of the new requirements contained in 
Directive 2001/18.  There is no evidence that this additional information was submitted at the request 
of the Commission or the lead CA.  In other words,  there is no reason to believe that the Commission 
was waiting for this information.  In our view, th erefore, the May 2002 information does not justify 
the Commission's failure to submit a draft measure  to the Regulatory Committee between November 
2000 and May 2002.      
7.1959  Separately, it should be noted that the SCP opi nion in this procedure dates from November 
2000.  Directive 90/220 was not repealed until almost  two years later.  In our assessment, there was 
thus enough time for the Commission to launch and complete inter-service consultations on a draft 
measure to be submitted to the Regulatory Commi ttee and for the Commission to adopt its draft 
measure in the event of a favourable vote in the Regulatory Committee.
1466  In our assessment, the 
Commission's inaction cannot, therefore, be excu sed on the grounds that the approval procedure 
concerning Bt-11 maize (EC-69) could not be comp leted while Directive 90/220 was still in force. 
7.1960  In our earlier findings on the application concerning Bt-11 maize (EC-69), we noted that the 
Commission could have considered that due to the "blocking minority" of the Group of Five countries 
in the Regulatory Committee and the Council, a favourable draft measure would not achieve the 
required qualified majority and that the Commission would then have to complete the procedure by 
adopting its draft measure.  In our view, even in this scenario, there was enough time for the 
Commission to complete the procedure in question while Directive 90/220 was still in force.  But 
even if it the Commission considered it doubtfu l that there would be enough time in view of 
                                                      
1466 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory 
Committee voted on the application less than three months after the SCP issued its opinion.  Exhibit 
EC-76/At. 72. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 760 
  
  anticipated member State opposition, the Panel does not  consider that this would have justified the 
Commission's failure to forward a draft measure to the Regulatory Committee.  On the other hand, the 
Commission could have anticipated a "blocking minority" on the basis of the June 1999 declaration 
by the Group of Five countries.  Yet, as pointed out above, there is no indication that the June 1999 
declaration was intended to bind the Governments of the Group of Five countries vis-à-vis  other 
member States or the Commission.  In other words,  the Group of Five countries retained the freedom 
under EC law to vote in favour of applications in the Regulatory Committee and Council.  In the light 
of this, we think the Commission could not have i nvoked the June 1999 declaration as a justification 
for not submitting a draft measure to the Regulatory Committee prior to October 2002.  
7.1961  Based on the above considerations, the Panel is of the view that, in the specific circumstances 
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure 
to the Regulatory Committee – no draft measure was forwarded between late November 2000 and 
October 2002 – was unjustifiably long.  
7.1962  In addition, we recall that the United States claims that the approva l procedure concerning 
Bt-11 maize (EC-69) was unduly delayed because, due to the moratorium, the European Communities 
failed to consider the application in question for fi nal approval.  In this respect, we note our earlier 
findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent 
with the application of such a moratorium.  In the li ght of this, and in the absence of effective rebuttal 
by the European Communities, we ag ree with the United States that it is reasonable to infer that the 
Commission's inaction was a consequence of the general moratorium on approvals.   
7.1963  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United 
States in support of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .  
Conclusion
 
7.1964  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to prepare and forward a draft measure to the Regulatory Committee 
once the SCP had issued its opinion – no draft measure was forwarded between late November 2000 and October 2002 – was unjustifiably long, and that it can reasonably be inferred from surrounding circumstances that  the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the 
general moratorium, the European Commun ities failed to consider the application 
concerning Bt-11 maize (EC-69) for final a pproval, and that this resulted in "undue 
delay" in the completion of the relevant a pproval procedure.  Accordingly, the Panel 
concludes that in respect of the approva l procedure concerning Bt-11 maize (EC-69), 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 761 
  
  (x) RR oilseed rape (EC-70) 
7.1965  Two Complaining Parties, the United States and Canada, claim that the completion of the 
approval procedure concerning RR oilseed ra pe (EC-70) has been unduly delayed.  
7.1966  The United States  argues that this application was delayed at the member State level for 
more than four years.  The United States submits that although the applicant in this procedure provided answers to all of the questions raised by  the lead CA, the lead CA failed to approve the 
product under Directive 90/220.  More specifically, the United States argues that the total time taken 
at the member State level for the initial review w as 54 months (7 July 1998 to 22 January 2003), of 
which 12 months were taken by the applicant to r espond to questions.  The United States asserts that 
an additional 10 months of the total time taken were  spent resolving confidentiality issues in relation 
to detection methods.  Thus, according to the United States, the lead CA in this procedure took 32 
months for its review instead of the 90 days referred to in Article 12 of Directive 90/220.  The United 
States considers this delay in completing the approval procedure concerning RR oilseed rape (EC-70) 
to be undue. 
7.1967  The United States notes, in addition, that Denm ark, Italy, Belgium, Austria, France and 
Germany all objected to the lead CA's favourable in itial assessment on the grounds that new EC rules 
concerning the traceability and labelling of biotech pr oducts needed to be in place before they could 
support the approval of any application.  The Unite d States submits that this shows an unwillingness 
to acknowledge the strength of the scientific conc lusions reached by the lead CA and opposition to 
approval regardless of the merits of the application in question.  The United States notes, in addition, 
that Austria and Denmark also objected because in their view issues concerning liability and 
coexistence remained to be reso lved.  The United States submits th at a desire for rules addressing 
these issues cannot justify delay.  Otherwise, a Member could always say it would like a better 
regulatory regime in aspects unrelated to the en vironment, human or animal health and delay 
approvals indefinitely, rendering the "n o undue delay" discipline meaningless.  
7.1968  The United States also points out that the appli cation concerning RR oilseed rape (EC-70) is 
one of nine applications identified by the United States which have been pending at the member State 
level for an average of three years and ten months.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
RR oilseed rape (EC-70) is undue.  The United St ates further argues that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.1969  Canada  notes that in February 2000, the Dutch State Institute for Quality Control of 
Agricultural Products (RIKILT-DLO), which is resp onsible for providing scientific opinions relating 
to feed safety, issued a favourable assessment of RR oilseed rape (EC-70).  On 10 January 2001, the 
Dutch Committee on Genetic Modification (COGEM), wh ich is responsible for providing scientific 
advice relating to human health and the environm ent, concluded its assessment with a favourable 
conclusion.  In January 2003, the Netherlands CA published a favourable overall assessment report.  
Canada submits that the two-year delay by the Netherlands CA in completing its overall assessment 
report and forwarding it to the Commission is unjustified and excessive.    
7.1970
 Canada also argues that the total time taken by  the Netherlands to review this file was 54 
months (7 July 1998 to 22 January 2003).  Out of these 54 months, the applicant took a total of 12 
months to respond to questions.  Another 10 months  were used for discussions of the confidentiality 
status of certain information submitted by the app licant beyond the legal requirements of the approval WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 762 
  
  legislation then in force.  Canada submits that ev en if the latter period of time were not taken into 
account in this calculation, the remaining 32 months are in stark contrast to the 90 days foreseen in Directive 90/220 for this procedural step.  In Canada's  view, it is reasonable to infer from this that in 
the light of the moratorium, the Dutch authorities were taking a decidedly go-slow approach.  
7.1971  Regarding the delay caused by the issue of c onfidentiality, Canada notes that Annex C(1)(d) 
of the SPS Agreement  states that WTO Members shall ensure "the confidentiality of information about 
imported products arising from or supplied in connection with cont rol, inspection and approval is 
respected […] in such a manner that legitimate comm ercial interests are protected".  Under Article 25 
of Directive 2001/18, an applicant is entitled to re quest that commercially sensitive information be 
protected, which the applicant in this case did in Ma rch 2001.  Canada is therefore of the view that 
delays arising from an applicant seeking to ensure  the fulfilment of obligations, both under the 
SPS Agreement  and domestic law, relating to the protecti on of legitimate commercial interests should 
not be attributed to the applicant. 
7.1972  In addition to the foregoing, Canada submits th at the failure by the European Communities to 
approve this product under Directiv e 2001/18 compounds the already unj ustified and excessive delay.  
Canada submits that repeated, unj ustified "road-blocks" that have been imposed by member States 
resulting in excessive delays – unjustified objections  to the lead CA's favourable initial assessment in 
March 2003, the failure of the Regulatory Committee to  obtain a qualified majority at its meeting of 
16 June 2004 – demonstrate that the European Communities has violated its obligations under 
Annex C(1) of the SPS Agreement . 
7.1973  Regarding member State objections, Canada notes that Denmark, Italy, France, Austria and 
Belgium raised objections, not on the basis of safety concerns, but on the grounds that approval of the 
application in question should be suspended pe nding the adoption of new EC legislation on 
traceability and labelling.  Canada further contends that Denmark (in relation to transport of RR 
oilseed rape (EC-70)) and Italy (in relation to herbic ide use) raised objections outside the scope of the 
assessment foreseen by Directive 2001/18.  Finally, Ca nada argues that objections were raised which 
were irrelevant in the light of the scope of the requested approval ( i.e. for import and processing).  
Denmark requested that a monitoring plan should in clude observations on dispersal and gene transfer 
to oilseed rape and wild relatives.
1467  Likewise, Italy, the United Kingdom, Spain and Austria 
objected on the basis that a post-market monitori ng plan needed to be proposed to assess seed 
spillage.  Canada submits that the European Communities' scientific committee has confirmed 
repeatedly, and in particular for oilseed rape, that  the mere fact of potential dispersal of seeds and 
gene transfer among domesticated  or wild relatives is not per se  negative for human health or the 
environment.  Moreover, Canada points out that the scope of the approval was for import only, as 
opposed to planting – a fact that does not normally  attract attention to seed spillage, because the 
imported grain is processed at the port of entry where spillage is controlled in compliance with 
statutory standards and to avoid economic loss.    
7.1974  Canada also argues that the total time for me mber State review of the lead CA's initial 
assessment was eight months (22 January 2003 to  6 October 2003) instead of 105 days, the time-
period envisaged in Article 15 of Directive 2001/18. 
7.1975  Regarding the failure of the Regulatory Comm ittee to obtain a qualified majority at its 
meeting of 16 June 2004, Canada notes that prio r to the vote, EFSA rendered a favourable opinion 
and that in rendering its favourable opinion, EFSA co nsidered all of the member States' objections in 
relation to safety issues.  Canada considers, theref ore, that whatever the rationalization for member 
                                                      
1467 Exhibit EC-70/At. 26.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 763 
  
  States to vote against or abstain from voting, such rationalizations were not justified by science-based 
health or safety considerations.  In Canada's vi ew, it follows that the failure of the Regulatory 
Committee to approve the application fo rced additional unwarranted delays. 
7.1976  Finally, Canada contends that the length of time  it has taken, so far, for this application to 
move through the approval system – seven years – is, by any reasonable standard, "undue" and therefore a violation of Annex C(1)(a), keeping in mi nd that it still has not been approved.   However, 
the amount of time this application has languished in  the approval procedure is not the sole reason for 
Canada's claim that the delay has been undue.  Fi rst and foremost, the European Communities has had 
in place, since October 1998, an unjustified moratorium on approvals.  Furthermore, the refusal to 
approve the application concerning RR oilseed rape (EC-70) is not based on a risk assessment, despite 
numerous favourable risk assessments conducted by  the European Communities' own scientific 
committees.   
7.1977  The European Communities  argues that in this procedure there was a continuous exchange 
of correspondence between the lead CA and the a pplicant until December 2002, when the applicant 
updated its application in accordance with the requi rements of Directive 2001/18.  According to the 
European Communities, this period of time was entirel y dedicated to resolving scientific and technical 
issues, such as molecular characterisation and fe ed safety.  The lead CA requested additional 
information on molecular characterization and on certa in feed safety aspects, and exchanges regarding 
these issues continued until the year 2000.  Afte r the adoption of Directive 2001/18 in March 2001, 
the lead CA asked the applicant to provide in formation on a detection method as required under the 
new legislation.  The applicant requested confidenti ality status for the information to be provided.  
The lead CA initially did not accept the reasons provided for requesting that status and several letters 
were exchanged on the issue.  The lead CA also re quested reference material which again triggered a 
debate on confidentiality.  The European Communiti es notes that these issues were only settled in the 
autumn of 2002.  By that time, Directive 2001/18  had entered into force and the lead CA and 
applicant worked on up-dating the application accordi ng to Directive 2001/18.  As regards the issue of 
confidentiality, the European Communities submits that  it was at the request of the applicant that the 
discussion on these issues was undertaken and that the European Communities cannot be responsible 
for any slippage in the timetable resulting from a request made by an applicant. 
7.1978  The European Communities further points out th at once the applicant had provided an update, 
the application moved immediately to the Communi ty level.  A few member States requested 
additional information and six member States raised  objections.  The objections related to issues of 
molecular characterisation (insufficient data), f eeding studies, the monitoring plan, allergenicity, 
detection/identification methods as well as traceabilit y and labelling.  Meetings were held with the 
applicant to settle these issues and the applicant provided additional information.  The European 
Communities contends that the objections raised by member States were based on legitimate and 
scientifically sound concerns, or regulatory requireme nts outside the scope of this dispute (traceability 
and labelling).  
7.1979  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.1980  We note that in the approval procedure con cerning RR oilseed rape (EC-70), the applicant 
submitted an application to the lead CA (the Ne therlands) on 7 July 1998.  When Directive 90/220 
was repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission.  The dossier was forwarded to the Commission with  a favourable assessment report on 16 January 
2003, after the applicant had provid ed an updated application in accordance with Directive 2001/18.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 764 
  
  7.1981  The United States and Canada assert that th e lead CA took too long to complete its 
assessment.  They note that the lead CA took mu ch more time for its own assessment of the 
application than the 90 days envisaged in Article 12(2) of Directive 90/220.
1468  We consider that this 
is correct.1469  However, whether or not the lead CA co mplied with the 90-day deadline stipulated in 
Directive 90/220 in our view is not dispositive, per se , of whether the European Communities met its 
WTO obligation to complete its approval procedur es without undue delay.  Indeed, legislation of 
different WTO Members may stipulate deadlines for th is type of assessment which are more or less 
strict.  Nevertheless, we consider that the dead line set forth in Directive 90/220 provides a useful 
indicator to guide the Panel's analysis.  The 90-da y deadline is binding and applies to all relevant 
applications submitted under Directive 90/220.  It may therefore be assumed that the EC legislator set 
this binding deadline in such a wa y as to make it possible for the CAs of all member States to assess 
even complex applications w ithin the prescribed deadline.1470   
7.1982  In the present case, however, the European Commun ities contends that all of the time taken 
by the lead CA until December 2002, when the app licant complemented its application in accordance 
with the requirements of Directive 2001/18, was necessary to resolve scientific and technical 
issues.1471  Since we do not view the fact that th e 90-day deadline was exceeded as dispositive, per se , 
we go on to examine whether the lead CA was just ified in forwarding an assessment report to the 
Commission only in mid-January 2003. 
7.1983  In its earlier findings on the approval procedure concerning RR oilseed rape (EC-70), the 
Panel noted its understanding that when evaluati ng applications for placing on the market, the 
Netherlands CA notably took into consideration the advice from the COGEM and the opinion of the 
RIKILT-DLO.  In the approval procedure in que stion, the RIKILT-DLO submitted its favourable 
opinion in February 20001472, and the lead CA advised the applicant in March 2000 in an e-mail that 
no further technical information for the risk assessment needed to be supplied.1473  The COGEM did 
not provide its favourable advice until 10 January 2001.1474   
7.1984  Regarding the advice from the COGEM, it should be recalled that the COGEM met in 
September 1998 to discuss the application in question.  This led to a request for additional information 
on molecular characterization, which was transm itted to the applicant also in September 1998.1475  
The applicant provided the request ed information in December 1998.1476  Yet the COGEM did not 
meet again to discuss the application and the addi tional information for another two years.  The 
relevant meeting took place in December 2000,  a month before the COGEM provided its final 
                                                      
1468 We recall that the 90 days envisaged in Directive 90/220 do not include any periods of time during 
which the lead CA is awaiting further inform ation which it requested from the applicant. 
1469 For instance, as is clear from Exhibit EC-70, the lead CA was assessing the application between 13 
August 1998 and 25 September 1999; between 2 April 1999 and 17 August 1999; and between 18 November 
1999 and 21 January 2000 when the RIKILT-DLO appears to have requested additional information (Exhibit EC-70/At. 17).  These periods of time, which are but exam ples, already add up to more than seven months.    
1470 Our remarks concerning the 90-day deadline set out in Article 12(2) of Directive 90/220 are also 
applicable, mutatis mutandis , to the corresponding 90-day deadline set out in Article 14(2) of Directive 2001/18.    
1471 EC second written submission, para. 199. 
1472 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent 
Authority (GT73), p. 5; see also  Exhibit CDA-57. 
1473 Exhibit EC-70/At. 18; Exhibit CDA-132. 
1474 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent 
Authority (GT73), p. 5; see also  Exhibit CDA-57. 
1475 Exhibit EC-70/At. 7. 
1476 Exhibit EC-70/Ats. 9 and 10.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 765 
  
  advice.
1477  The record does not support the inference that the COGEM provided its advice only in 
January 2001 because it needed to reso lve scientific or technical issues.  Nor is there any indication in 
the record that the COGEM had other reasons for delaying the provision of its advice.  There is 
therefore no apparent reason why the COGEM could not have provided its advice before or by the 
time the lead CA informed the app licant by e-mail that no further tec hnical information needed to be 
submitted, i.e., before or by March 2000.   
7.1985  In the light of the foregoing, the Panel consider s that at the latest in March 2000 the lead CA 
could have had all the elements to complete its assessment report.  The European Communities notes 
that the applicant submitted additional information in  April and May 2000.  It is correct that in the 
aforementioned e-mail of March 2000 from the lead CA to the applicant, the l ead CA also noted that 
the legal name and registration of the applicant woul d need to be confirmed, and that the original 
application would need to be modifi ed to take into account the add itional information submitted in the 
course of the assessment process.1478  In April 2000, the applicant confirmed its legal name and 
registration.1479  And in mid-May 2000, the applicant sent a draft document to the lead CA to indicate 
how it intended to modify the original application and to ask for comments and suggestions.1480  The 
lead CA replied that it would co mmunicate its "findings" as soon as possible, probably within less 
than a fortnight.1481  This estimate demonstrates that the document submitted in mid-May 2000 did not 
call for a lengthy analysis by the lead CA.  Moreove r, the Panel does not consider that the March 2000 
e-mail from the lead CA constitutes a formal requ est for information which triggered a clock-stop.1482   
7.1986  If, as the Panel believes, the lead CA could ha ve obtained all necessary elements at least by 
March 2000, it may reasonably be assumed that the lead CA could have completed its assessment 
report at the latest 90 days later, i.e., around the end of June 2000.  It should be recalled that 
Article 12(2) of Directive 90/220 requires that "at th e latest 90 days after receipt" of an application, 
the lead CA must, in the case of a favourable asse ssment, forward the application to the Commission 
with a favourable opinion.  The Panel has already observed in respect of the corresponding 90-day 
deadline stipulated in Directive 2001/18 that that d eadline provides a useful indicator for determining 
how much time might be needed to complete an me mber State level assessment.  Assuming that 90 
days would have been sufficient seems all the mo re reasonable as by March 2000 the lead CA had 
already assessed the application for more than the 90 days envisaged in Article 12(2) of 
Directive 90/220.1483   
7.1987  Based on the foregoing considerations, the Pane l considers that the lead CA could have 
forwarded its assessment report to the Commission well before the end of 2000 and thus much before 
                                                      
1477 Exhibit EC-70/At. 17, p. 2 (in Dutch), Letter of 10 January 2001 by the COGEM to the Netherlands 
CA, p. 2.  See also  Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent 
Authority (GT73), p. 5. 
1478 Exhibit EC-70/At.  18. 
1479 Exhibit EC-70/At. 19.  In addition, the applicant sent some information which the European 
Communities acknowledges had already been transmitted to  the lead CA.  EC reply to Panel question No. 152. 
1480 Exhibit EC-70/At. 21.  The Panel fails to see a basis for the European Communities' contention that 
the relevant draft document was "a new element in the authorization process because it change[d] the terms of the application".  Nor does the Panel think that Exhibit EC-70/At. 23 supports the conclusion that the lead CA 
was still "analys[ing] the update" in November 2 000.  EC reply to Panel question No. 152.   
1481 Exhibit EC-70/At. 22. 
1482 Indeed, the chronology provided to the Panel by the European Communities does not describe the 
communication as such, which is in contrast to other entries in the chronology.  Exhibit EC-70/At. 18. 
1483 As noted previously and by way of example, the lead CA was assessing the application between 13 
August 1998 and 25 September 1999 as well as between 2 April 1999 and 17 August 1999.  These periods of 
time add up to more than 90 days.  Exhibit EC-70.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 766 
  
  mid-January 2003.  This means that, contrary to th e European Communities' c ontention, not all of the 
time taken by the lead CA up to December 2002 w as necessary to resolve scientific and technical 
issues.  Moreover, the lead CA's failure to comp lete and forward an assessment report before the end 
of 2000 could not, in the Panel's view, be excused on the basis that there wa s insufficient time to 
complete the approval procedure concerning RR oilseed  rape (EC-70) while Directive 90/220 was still 
in force.  Directive 90/220 was not repealed un til October 2002.  There was thus enough time for the 
other member States to review the lead CA's as sessment report within 60 days following the 
circulation of the assessment report and, in the ab sence of objections, for the lead CA to give its 
consent to the placing on the market of RR oilseed rape (EC-70).
1484  
7.1988  In its earlier findings, the Panel also stated that even assuming that the COGEM could not 
have provided its advice before January 2001, the Netherlands could still have completed and 
forwarded its assessment report soone r than it did.  Specifically, the Panel noted that when the 
COGEM provided its advice in January 2001, the lead  CA did not complete its assessment report but 
on 12 March 2001 – the date of adoption of Direc tive 2001/18 – requested a detection method based 
on the provisions of Directive 2001/18, even thou gh that Directive did not enter into force until 
October 2002.  The applicant provided a detection method four days later.1485  However, the applicant 
requested confidential treatment of the detection me thod.  This resulted in an eight-month exchange 
with the applicant.  As we noted earlier, during that exchange, the lead CA caused delays by not 
requesting clarification promptly.  Our examina tion focuses on the delays caused by the lead CA 
during the course of the exchange over confidentiality issues. 
7.1989  We begin our examination by recalling relevant facts.  In May 2001, the lead CA asked the 
applicant to reconsider its request for confidential treatment of the detection method it had submitted, 
or else to provide further substantiation.  The lead  CA also stated that in the absence of further 
substantiation by June 2001, it would take  a decision with respect to the request.1486  In September 
2001, after providing further clarification at the request of the lead CA and "in order to keep the 
approval process moving forward", the applicant agreed  to disclose the protocol for the detection of 
RR oilseed rape (EC-70).  But the applicant request ed that the primer sequences in the protocol 
remain confidential until the first patent application was published.1487  In response, the lead CA again 
sought further substantiation.  After receiving additi onal substantiation, the l ead CA in January 2002 
granted the request that the primer seque nces should be treated as confidential.   
7.1990  It is clear from these facts that there was a disagreement between the lead CA and the 
applicant regarding whether certain information was by nature confidential.  Article 19 of 
                                                      
1484 In its earlier findings on the application concerning RR oilseed rape (EC-70), the Panel noted that 
the Netherlands could have considered that for as long  as Directive 90/220 was still in force, there was no 
realistic prospect that the Group of Five countries and the Commission would allow the final approval of the 
application in question.  However, the Panel does not cons ider that this would have justified the Netherlands' 
failure to forward an assessment report to the Commissi on.  The Netherlands might have anticipated opposition 
from the Group of Five countries on the basis of their June 1999 declaration.  As pointed out above, 
notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to approve 
applications.  The same is true for the Commission, which had not issued a declaration comparable to that of the 
Group of Five countries.   
1485 As Directive 2001/18 was not yet in force on the date of the lead CA's request, the applicant was 
arguably not obliged, as a matter of EC law, to comply with it.  In our view, there can be no doubt in view of the wording of the lead CA's request for a detection method  that the applicant was aw are that the basis for the 
request was legislation not yet in force.  But there is no  indication in the record that  the applicant contested the 
propriety of the request. 
1486 Exhibit EC-70/At. 26. 
1487 Exhibit EC-70/At. 30.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 767 
  
  Directive 90/220 provides that in such cases it is for th e lead CA to decide, after consultation with the 
applicant, whether the information should be treated as confidential.
1488  It appears to the Panel that 
the lead CA was following this procedure.  However, it took a long time – eight months – to resolve 
the issue of the confidentiality status of the relevant  information.  While the applicant took a total of 
three and a half months to reply to the several requ ests for further substantiation, in June 2001 the lead 
CA waited for more than a month after receiving fu rther substantiation before  it followed up with a 
request for yet more substantiation.1489  A similar situation arose in September 2001 when the lead CA 
waited for more than two months befo re following up with another request.1490  The substantiation 
provided by the applicant in June and September 2001 was neither very extensive nor particularly 
complex.1491  Moreover, in June and September 2001, ther e was no apparent reason for the lead CA to 
consider that there was insufficient time to a pprove the application before Directive 90/220 was 
repealed in October 2002.  The Panel therefore does not see any justification for the lead CA's failure 
to follow up more promptly.  In the Panel's view, th e lead CA's delayed action in response to the June 
and September submissions of the applicant de monstrates that, contrary to the European 
Communities' contention, not all of the time ta ken by the lead CA up to December 2002 was 
necessary to resolve scientifi c and technical issues.   
7.1991  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning RR oil seed rape (EC-70) – notably the time spent waiting 
for COGEM to provide its advice, and the time take n to follow up on substantiation provided by the 
applicant for its request for confidential treatment of certain information – was unjustifiably long.  
7.1992  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning RR oilseed rape (EC-70) was unduly de layed because, due to the moratorium, the 
European Communities failed to consider the appli cation in question for final approval.  In this 
respect, we note our earlier findings that (i) a general de facto  moratorium on approvals was in effect 
in the European Communities between June 1999 and A ugust 2003 and that (ii) the time taken by the 
Netherlands to complete its assessment is consistent with the application of such a moratorium.  In the 
light of this, and in the absence of effective rebutta l by the European Communities, we agree with the 
United States that it is reasonable to infer that  the Netherlands' conduct was a consequence of the 
general moratorium on approvals. 
7.1993  In view of our conclusion with regard to the time taken by the Netherlands for its assessment, 
we do not go on to examine other arguments put fo rward by the United States and Canada in support 
of their claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusions  
7.1994  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning RR oilseed rape (EC-70) was unjustifiably long, and that it can reasonably be inferred from surrounding 
                                                     
 
1488 Canada refers to the analogous provisions of Article 25 of Directive 2001/18.  However, these 
provisions were not applicable at the time. 
1489 Exhibit EC-70/At. 28. 
1490 Exhibit EC-70/At. 33. 
1491 The June letter from the applicant is two pages long, that of September is only one page long. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 768 
  
  circumstances that the l ead CA's conduct was a consequence of the general 
moratorium on approvals.  Based on these findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European 
Communities failed to consider the appli cation concerning RR oilseed rape (EC-70) 
for final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning RR oilseed rape (EC-70), the European Communities 
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
  (ii) DS292 (Canada)    With reference to DS292, the Panel recalls its finding that the time taken by the lead 
CA for its assessment of the application concerning RR oilseed rape (EC-70) was 
unjustifiably long.  Based on this finding, th e Panel accepts Canada's contention that 
the European Communities failed to "consider  or approve, without undue delay", the 
application concerning RR oilseed rape (EC-70), and that it consequently did not complete the relevant approval procedure without "undue delay".  Accordingly, the 
Panel concludes that in respect of the a pproval procedure concerning RR oilseed rape 
(EC-70), the European Communities has breached its obligations under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
 
(xi) LL soybeans (EC-71) 
7.1995  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning LL soybeans (EC-71) has been unduly delayed.   
7.1996  The United States  submits that although the applicant in  this procedure provided answers to 
all of the questions raised by the lead CA, the lead CA failed to approve the product under 
Directive 90/220. 
7.1997  The United States also points out that the app lication concerning LL soybeans (EC-71) is one 
of nine applications identified by the United Stat es which have been pending at the member State 
level for an average of three years and ten months.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
LL soybeans (EC-71) is excessive and unjustified and, hence, undue.  The United States further 
argues that before the European  Communities adopted its moratorium, all approval procedures under 
Directive 90/220 were undertaken and co mpleted in less than three years. 
7.1998  Argentina  claims that the application was delayed at the member State level for 68 months 
without a final decision on its approval.  Argentin a asserts that the Eur opean Communities neither 
processed the application nor conducted the required ri sk assessment.  Argentin a argues that there is 
no scientific justification for the delay, as the "initial reports" were not prepared. 
7.1999  The European Communities  provides three explanations for the delay at the member State 
level: (1) requests by the lead CA for further information during the pe riod from September 1998 to 
2001; (2) procedural problems arising from the fact th at the applicant submitted an application for the 
same product in Portugal; and (3) delays caused by the applicant's lack of response to requests for 
additional information on 25 February 2003.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 769 
  
  7.2000  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2001  We note that in the approval procedure c oncerning LL soybeans (EC-71), the applicant 
submitted an application to the lead CA (Belgium ) on 28 September 1998.  In September 1999, the 
applicant submitted an application for this same  product to Portugal.  When Directive 90/220 was 
repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission.  The applicant updated the application on 15 January 2003.  Also in January 2003, the applicant withdrew the parallel application to Portugal.  
7.2002  We recall that in relation to Belgium's assessm ent of LL soybeans (EC-71) three separate time 
periods can be usefully distinguished:  (1)  the ti me period between the submission of the application 
to the Belgian CA and the concurrent submissi on in Portugal;  (2) the time period between the 
submission of the concurrent application in Portugal and the repeal of Directive 90/220;  and (3) the time period between the submission of the appli cation under Directive 2001/18 and the applicant's 
withdrawal of the application. 
7.2003  The Panel begins its analysis with the allege d delay at member State level during the period 
before the parallel application was submitted to Port ugal.  We recall that in a letter dated 31 March 
1999, the Belgian Biosafety Council stated that it was "of the opinion that the file [concerning the application submitted under Directive 90/220] in its present form (with addition of molecular data and 
after minor corrections) can be passed on to the European Commission with a positive opinion".
1492  
Based on the March 1999 advice by the Biosafety Council the Belgian CA on 28 May 1999 asked for 
more information, including information on mo lecular characterization, nutritional analysis 
(concerning the approval procedure for LL soybeans (EC-93)) and herbicide aspects.1493  T h e  
applicant did not respond to the May 1999 request until July 2001. 
7.2004  The European Communities provides no justificati on for the time taken by the lead CA to 
forward the request for additional information from the Belgian Biosafety Council.  While the lead 
CA as the responsible agency could review the request in order to determine whether it was 
appropriate to transmit it to the applicant, we ar e not convinced, in the absence of any justification 
offered by the European Communities, that two mont hs were needed to review this straightforward 
request for additional information. Indeed, at an ear lier stage in the approval procedure, the lead CA 
forwarded a similar request from the Biosafet y Council within a matter of several days.1494  W e  
therefore consider that the lead CA could and shoul d have acted more promptly than it did when the 
Biosafety Council suggested a request for a dditional information in March 1999.   
7.2005  As noted, the applicant did not respond to the lead CA's May 1999 additional request for 
information until July 2001, i.e., more than two years later.  Me anwhile, however, the applicant had 
submitted an application to Portugal.  The time dur ing which a parallel application was maintained 
concurrently in Portugal contributed to the delaye d progress of the application in Belgium.  We note 
in this regard that in a communication to Belg ium dated 1 December 2000, the applicant explicitly 
indicated its intention of maintaining dual applications.1495  In this letter the applicant also stated it 
would take all necessary measures to ensure that  only one application would circulate at the 
Community level.  On 5 December 2000, the Bi osafety Advisory Council of the Belgian CA 
                                                      
1492 Exhibit EC-71/At. 16. 
1493 Exhibit EC-71/Ats. 17 and 22. 
1494 Exhibit EC-71/Ats. 4 and 5. 
1495 Exhibit EC-71/At. 23. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 770 
  
  confirmed the continuation of the evaluation proces s in Belgium and requested that the applicant 
forward the questions posed by the Portuguese CA in the approval procedure concerning LL soybeans 
(EC-81) in order to complete the application dossier in Belgium.
1496  On 5 September 2001, ten 
months after confirming the continuation of the evaluation process in Belgium, the Belgian CA 
indicated to the applicant that further evaluati on of the application would be suspended until the 
applicant specified a single country to handle the application.1497  The applicant responded on 8 
October 2001 by asserting the maintenance of double concurrent applications.1498  No further 
exchanges appear to have occurred between the a pplicant and the lead CA until January 2003, when 
the applicant updated the application submitted to Belgium under Directive 2001/18.  While there is 
no evidence on the record to confirm this, it appears th at in view of the applicant's response the lead 
CA did not further assess the application concer ning LL soybeans (EC-71) between October 2001 and 
January 2003.  Thus, the consideration of the app lication appears to have been suspended as from 
September 2001 as a result of the applicant's refusal to discontinue one of the two applications 
submitted under Directive 90/220.    
7.2006  We note that the applicant was of the view th at Directive 90/220 did not prevent it from filing 
identical applications to different lead CAs.  It  nevertheless acknowledged th at this approach could 
give rise to procedural problems, and it therefore indicated that it would withdraw one of the two 
applications as soon as one of the applications wa s ready for transmission to the Commission.  The 
Belgian CA appears to have considered that the approach followed by the applicant was either not 
permitted by Directive 90/220 or otherwise inappropriate.   
7.2007  The United States and Argentina did not submit arguments or evidence which would indicate 
that Belgium's position rested on an incorrect  interpretation of Directive 90/220.  While 
Directive 90/220 does not explicitly require that app lications be maintained with a single competent 
authority, it also does not explicitly state that app lications may be maintained with more than one 
competent authority.  We note that the issue of parallel applications arose also in the approval 
procedure concerning Bt-11 maize (EC-80).  In that pr ocedure, the lead CA in Spain did not appear to 
consider this a problem.1499  On the other hand, it should also be noted that the applicant in the 
procedure concerning LL soybeans (EC-71) apparently did not contest Belgium's refusal to continue 
to consider its application. 
7.2008  From the information before us, it is not appare nt that Belgium's position on this issue, which 
appears to have led it to suspend consideration of the application concerning LL soybeans (EC-71) 
under Directive 90/220, was a mere pretext for delaying the consideration of the application.  Indeed,  
Belgium indicated to the applicant that it would con tinue considering the relevant application if the 
applicant decided to discontinue the application su bmitted to Portugal.  Furthermore, in applying the 
provisions of Annex C(1)(a), first clause, we think we must be mindful of Members' limited resources 
and the consequent need to avoid unnecessary duplica tion and administrative inefficiencies.  Thus, a 
delay in the consideration of an application wh ich was caused by a Member's refusal to conduct 
concurrent approval procedures in respect of an id entical application does not appear to us to be 
unjustifiable per se .  Taking account of these elements, we are not convinced that in the specific 
circumstances of this case, Belgium's refusal to c ontinue its assessment of the application concerning 
LL soybeans (EC-71) while the applicant maintained its  concurrent application to Portugal resulted in 
a loss of time which was unjustifiable.   
                                                      
1496 Exhibit EC-71/At. 24. 
1497 Exhibit EC-71/At. 28. 
1498 Exhibit EC-71/At. 29. 
1499 Exhibit EC-80/At. 12.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 771 
  
  7.2009  Regarding the consideration of this application under Directive 2001/18, we note that after the 
applicant updated its application under Direc tive 2001/18 (15 January 2003) and withdrew its 
application in Portugal (27 January 2003), the Belgian CA acknowledged receipt of the updated 
application and requested further information regarding molecular ch aracterization, detection methods 
and reference materials.  The a pplicant provided preliminary informal answers regarding information 
for labelling requirements and detection methods in  March 2003.  There is no record of further 
exchanges between the applicant and the lead CA un til the applicant withdrew the application in July 
2004.  
7.2010  The European Communities claims that the de lay which occurred after the applicant had 
provided preliminary informal answers was attributable  to the applicant.  Th e record shows that the 
applicant provided a partial response to the lead CA's  request for additional information  and indicated 
that further information would be forthcoming rega rding reference samples of genomic DNA for this 
product.  Given the applicant's stated intention of  submitting further information to address questions 
from the lead CA and the lack of arguments addressing this issue from the United States and 
Argentina, it is reasonable to believe that the lead CA was waiting for the submission of further 
information.  Accordingly, we have no reason to disagree with the European  Communities' contention 
that the delay in question was attributable to the applicant rather  than the lead CA. 
7.2011  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning LL soybeans (EC-71) – specifically the time taken by the 
lead CA to forward the request for additional in formation suggested by the Biosafety Council in 
March 1999 – was unjustifiably long.  
7.2012  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning LL soybeans (EC-71) was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier finding that the record supports the conclusion that the European Communities applied a 
de facto  moratorium on approvals as of June 1999.  Our finding that the time taken by Belgium for its 
assessment of the application concerning LL soybeans (EC-71) was unjustifiably long is based on the view that the lead CA could and should have  transmitted its May 1999 request for additional 
information earlier than it did.  Thus, our finding above relates to a time period which pre-dates June 
1999.  In the light of this, we do not  consider that we can infer that  Belgium's conduct in March, April 
and May 1999 was a consequence of the general mo ratorium on approvals which we found was in 
effect between June 1999 and August 2003.  
7.2013  In view of our conclusion above, in relation to DS291 we need to go on to examine other 
arguments put forward by the United States in support  of its claim under Annex C(1)(a), first clause, 
and Article 8 of the SPS Agreement .   
Total amount of time taken since submission of application
 
7.2014  The United States also puts forward the argument that the total amount of time during which 
the application concerning LL soybeans (EC-71) was pending is excessive and unjustified.  The 
application concerning LL soybeans (EC-71) was fi rst submitted for approval under Directive 90/220 
in September 1998.  This means that as of August 2003, the approval procedure had been pending for 
four years and eleven months. 
7.2015  The Panel agrees with the United States that, in absolute terms, this is a long period of time 
for the assessment by the lead CA.  However, as we ha ve explained earlier, the mere identification of WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 772 
  
  the total amount of time during which an applicati on has been pending does not demonstrate, in and 
of itself, that the time taken was unjustifiably long.   
7.2016  Moreover, even if the United States were corr ect in asserting that before there was an EC 
moratorium, approval procedures used to be completed in less than three years, it must be 
remembered that the European Communities assesses applications on a case-by-case basis.  Thus, the 
fact that the approval procedur e concerning LL soybeans (EC-71) was not completed in less than 
three years in our view does not demonstrate that it was not justifiable for the European Communities 
to take more time to process the application concerning LL soybeans (EC-71).
1500   
7.2017  The United States further argues that in the light of the acknowledgement by EC officials of 
the existence of a moratorium on approvals, the fact  that the application in question lingered at the 
member State level for almost five years demonstrates  the existence of undue delay.  We recall in this 
respect our finding that the record supports the c onclusion that  the European Communities applied a 
de facto  moratorium on approvals as of June 1999.  At that time, the application concerning LL 
soybeans (EC-71) had already been pending for almost  nine months.  Thus, some of the total time 
taken cannot be explained by the mo ratorium.  Moreover, the mere fact  that a general moratorium was 
in effect does not necessarily imply that each particular  application was affected by it at all stages of 
the procedure.  The United States itself has repeatedly  stated that "the moratorium was a decision by 
the EC not to move products to a final decision in the approval process" and that "certain progress in 
the process, short of a final decision, is not the least bit inconsistent with a moratorium on final 
approvals".1501  Therefore, by itself, the fact that a moratorium on approvals was in effect between 
June 1999 and August 2003 is not sufficient to demo nstrate that the period of time during which the 
application concerning LL soybeans (EC-71) was pending as of August 2003 reflects a failure on the 
part of the lead CA to complete the releva nt approval procedure  without undue delay.  
7.2018  Accordingly, the Panel is unable to accept the United States' assertion that the total period of 
time during which the application concerning LL soybeans (EC-71) had been pending as of August 
2003 demonstrates that the time taken was unjustifiably long. 
Conclusions  
7.2019  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that it has not been established 
that the time taken by the lead CA for its assessment of the application concerning LL 
soybeans (EC-71) was unjustifiably long, or th at the total period of time during which 
the application concerning LL soybeans (E C-71) had been pending as of August 2003 
demonstrates that the time taken by the European Communities was unjustifiably 
long.  Based on these findings, the Panel is unable to accept the United States' 
contention that, consistent with the gene ral moratorium, the European Communities 
failed to consider the application concer ning LL soybeans (EC-71) for final approval, 
and that this resulted in "undue delay" in the completion of the relevant approval 
procedure.  Accordingly, the Panel conc ludes that in respect of the approval 
                                                      
1500 It is worth recalling, more generally, that the approval procedures which were completed before 
there was a moratorium on approvals were not affected  by the special circumstance that Directive 90/220 was 
repealed in 2002.    
1501 See, e.g., US second written submission, para. 51 (emphasis in original).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 773 
  
  procedure concerning LL soybeans (EC-71), the United States has failed to establish 
that the European Communiti es has breached its obligations under Annex C(1)(a), 
first clause, and Article 8 of the SPS Agreement .  
 
 (ii) DS293 (Argentina)    With reference to DS293, the Panel recalls its finding that the time taken by the lead 
CA for its assessment of the application concerning LL soybeans (EC-71) was 
unjustifiably long.  In the light of this finding, the Panel concludes that the European 
Communities failed to complete the a pproval procedure concerning LL soybeans 
(EC-71) without "undue delay", thus breachi ng its obligations under Annex C(1)(a), 
first clause, and Article 8 of the SPS Agreement. 
 (xii) LL oilseed rape (EC-72) 
7.2020  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning LL oilseed rape has been unduly delayed.   
7.2021  The United States argues that the total time taken at the member State level for the initial 
review of this application was over four years, as this product still had not been forwarded to the 
Commission at the time of establishment of the Pane l.  The United States contrasts this with the 90 
days referred to in Directives 90/ 220 and 2001/18.  Although the Unite d States initially indicated that 
the applicant had provided answers to all of the qu estions from the lead CA, in response to a question 
from the Panel the United States recognized that the applicant failed to provide some of the data 
requested.
1502  Nonetheless, the United States contends that  the delays by the lead CA in completing 
the approval procedure concerning LL oilseed rape are undue. 
7.2022  The United States also points out that the appli cation concerning LL oilseed rape is one of 
nine applications identified by the United States wh ich have been pending at the member State level 
for an average of three years and ten months.  The United States contends in this respect that although 
time alone is not dispositive, in the light of the ackno wledgement by EC officials of the existence of a 
moratorium on approvals, this dela y in completing the approval pro cedure concerning LL oilseed rape 
is excessive and unjustified and, hence, undue.  The United States submits, in addition, that before the 
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.2023  The European Communities  argues that the time taken by the lead CA was necessary in 
order to ensure a valid safety assessment.  Following receipt of the application, the lead CA requested 
further information from the appli cant.  The lead CA also request ed a preliminary review by its 
scientific committee, the Advisory Committee on Re leases to the Environment (hereafter "ACRE").  
The ACRE found that the dossier c ontained inconsistent data on mo lecular characterization and was 
presented in a manner which made assessment difficu lt.  In December 1999, the lead CA requested 
the applicant to provide a substantial revision and clarification. 
7.2024  According to the European Commun ities, the applicant did not get back to the lead CA on this 
dossier for almost two years.  In January 2003, the applicant provided some up-dated documents in 
accordance with Directive 2001/18, but the European  Communities argues that the full dossier was 
not submitted.  During the first half of 2003, ther e were various exchanges between the lead CA and 
the applicant, and the applicant provided additional updates and information.  Following a request in 
                                                      
1502 US answer to Panel question No. 168. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 774 
  
  June 2003 for the re-submission of a complete dossi er, in March 2004 the applicant withdrew the 
pending notification and submitted a new notification.  The European Communities maintains that it cannot be responsible for delays arising at the instigation of the applicant. 
7.2025  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2026  We note that in the approval procedure concerni ng LL oilseed rape the applicant submitted an 
application to the lead CA (the United Kingdom ) on 28 January 1999.  When Directive 90/220 was 
repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission.  An 
updated application was submitted following the entr y into force of Directive 2001/18, although the 
record is not clear as to when a complete dossier was actually submitted.  At the time of establishment 
of the Panel, this application was still under consideration by the lead CA.   
7.2027  The United States contends that the lead CA took too long to complete its assessment.  It is 
correct that the lead CA took much  more time for its assessment of the application than the 90 days 
envisaged in Directives 90/220 and 2001/18.  Howeve r, we have observed that that deadline was not 
dispositive, per se , of whether the European Communities met its WTO obligation to complete its 
approval procedures without undue de lay.  Moreover, the European Communities contends that much 
of the time taken by the lead CA until August 2003 is attributable to failures by the applicant 
promptly to provide requested information.  Th e European Communities submits that without this 
information, it was not possible for the lead CA to complete its assessment and submit a report to the 
Commission.  We therefore need to examine whethe r the lead CA was justified in not completing its 
assessment by August 2003.   
7.2028  As we noted in our previous consideration of th is application, the record before us is not 
complete.  Following receipt of the applicati on, the lead CA promptly requested additional 
information from the applicant in February and Marc h 1999.  This information was provided in June 
1999, and the lead CA acknowledge d on 30 June 1999 that the clock had been "restarted".  One 
month later, the lead CA requested further informa tion, but this information was not provided by the 
applicant before the date of repeal of Directiv e 90/220.  The letter from the lead CA dated 20 July 
1999 requests that the applicant provide further info rmation and clarification on points raised in an 
annex to the letter, but the annex was not provided to us.1503   
7.2029  In November 1999, the lead CA apparently re quested the ACRE to provide guidance to the 
lead CA as to where the application needed impr ovement and noted that the ACRE would be asked 
for formal advice only at a later stage.  The prel iminary advice by ACRE was that there were a 
number of inconsistencies in the molecular data pr ovided, some deficiencies in the molecular studies 
and too much important material was in annexes rath er than being in the core dossier.  It was noted 
that the appropriate experimental data may have been supplied some where in the application dossier 
but it was not immediately obvious where it might be.1504  As advised by ACRE, the lead CA in 
December 1999 requested that the applicant undertake substantial revision and clarification of the 
dossier.  The lead CA suggested a meeting with the applicant later in the same month to provide the 
applicant with some guidance.  There is no evidence in the information before the Panel that such a 
meeting took place, and that the applicant provided what was requested in December 1999.  Indeed, 
the record shows no further communication from the a pplicant until January 2003, when the applicant 
updated its application under Directive 2001/18.   
                                                      
1503 Exhibit EC-72/At. 11. 
1504 Exhibit EC-72/At. 12.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 775 
  
  7.2030  On 16 January 2003, the applicant submitted an updated application under Directive 2001/18 
to the lead CA.
1505  In acknowledging receipt of the updated a pplication, the lead CA indicated, on 27 
January 2003, that the dossier was still incomplete and information requested in July and December 
1999 was still missing.1506  Further requests for clarifications or modification of the application were 
made by the lead CA in the first half of 2003, with  responses apparently provided by the applicant in 
May 2003.1507  On 13 June 2003, the lead CA requested further clarifications and suggested that a 
complete version of the application be re-submitted.1508  On 26 March 2004, the applicant withdrew 
the application, saying that certain elements of th at application were incomplete or out-of-date, and 
submitted a new one (C/GB/04/M5/4).1509   
7.2031  In reviewing the lead CA's conduct in this a pproval procedure, we note that the exchanges 
between the lead CA and the applicant generally took place in a timely fashion, with the lead CA 
reacting promptly to information provided by the a pplicant.  It is clear from the foregoing, however, 
that the consideration of the application concerning LL oilseed rape was delayed for almost two years 
between 2 December 1999 and the repeal of Directiv e 90/220 in October 2002, following a letter from 
the lead CA advising the applicant that the dossier  required substantial revi sion and clarification.  
Based on the information submitted to us, we understand that this gap was caused by the failure of the 
applicant to provide the additional information and cl arification requested by the lead CA in July and 
December 1999.  However, the precise reasons for th e failure of the applicant to respond to the 
information solicited by the lead CA in July and December 1999 are unclear.   
7.2032  We note that the United States has not specifically  challenged the justifiability of any of the 
requests for additional data or clarifications made  by the lead CA.  We nonetheless asked the experts 
advising us whether the information requested by  the lead CA up to and in December 1999 was 
necessary to ensure that conclusions  of the safety assessment were valid.1510  Dr. Nutti, the only expert 
who responded to this question, concurred that the deficiencies in the application as identified by the 
ACRE were such that the requested info rmation was necessary for the safety assessment.1511  Taking 
account of these elements, we have no grounds for considering that the lead CA's requests of July and 
December 1999 which led to the gap between December 1999 and January 2003 were not justified.     
7.2033  Regarding the assessment of the application concerning LL oilseed rape under 
Directive 2001/18, we note that the United States h as offered no specific arguments relating to the 
consideration of this application under Directive 2001/18.  At any rate, the facts as summarized by us 
above do not suggest that the time taken by the lead CA up to August 2003 for assessing the 
application under Directive 2001/18 was unjustifiably long.  We note in particular the repeated 
requests by the lead CA for completion of the updated application, and the fact that the applicant itself 
withdrew the application in March 2004 saying that  certain elements of its application were 
incomplete.   
7.2034  Based on the above considerations , the Panel is not persuaded that the time taken by the lead 
CA for its assessment of the application concer ning LL oilseed rape was unjustifiably long.  
                                                      
1505 Exhibit EC-72/At. 15. 
1506 Exhibit EC-72/At. 16. 
1507 Exhibit EC-72/Ats. 18 and 19. 
1508 Exhibit EC-72/At. 28. 
1509 Exhibit EC-72/At. 29. 
1510 Annex H, Panel Question 29. 
1511 Annex H, para. 600. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 776 
  
  Total amount of time taken since submission of application
 
7.2035  The United States also puts forward the argument that the total amount of time during which 
the application concerning LL oilseed rape was pendi ng is excessive and unjustified.  The application 
concerning LL oilseed rape was first submitted for approval under Directive 90/220 in January 1999.  
This means that as of August 2003, the approval proc edure had been pending for four years and seven 
months. 
7.2036  The Panel agrees with the United States that, in absolute terms, this is a long period of time 
for the assessment by the lead CA.  However, as we ha ve explained earlier, the mere identification of 
the total amount of time during which an applicati on has been pending does not demonstrate, in and 
of itself, that the time taken was unjustifiably long.   
7.2037  Moreover, even if the United States were corr ect in asserting that before there was an EC 
moratorium, approval procedures used to be completed in less than three years, it must be remembered that the European Communities assesses applications on a case-by-case basis.  Thus, the 
fact that the approval procedure concerning LL oil seed rape was not completed in less than three 
years in our view does not demonstrate that it w as not justifiable for the European Communities to 
take more time to process the application concerning LL oilseed rape.
1512   
7.2038  The United States further argues that in the light of the acknowledgement by EC officials of 
the existence of a moratorium on approvals, the fact  that the application in question lingered at the 
member State level for over four and a half years demonstrates the existence of undue delay.  We 
recall in this respect our finding that the reco rd supports the conclusion that the European 
Communities applied a de facto  moratorium on approvals as of June 1999.  At that time, the 
application concerning LL oilseed rape had already been pending for almost six months.  Thus, some 
of the total time taken cannot be explained by the mo ratorium.  Moreover, the mere fact that a general 
moratorium was in effect does not necessarily imply that a particular application was affected by it.  
The United States itself has repeatedly stated that "the moratorium was a decision by the EC not to 
move products to a final decision in the approval process" and that "certain progress in the process, 
short of a final decision, is not the least bit in consistent with a morato rium on final approvals".1513  
Therefore, by itself, the fact that a moratorium  on approvals was in eff ect between June 1999 and 
August 2003 is not sufficient to demonstrate that  the period of time during which the application 
concerning LL oilseed rape was pending as of August  2003 reflects a failure on the part of the lead 
CA to complete the relevant approv al procedure without undue delay.  
7.2039  Accordingly, the Panel is unable to accept the United States' assertion that the total period of 
time during which the application concerning LL o ilseed rape had been pending as of August 2003 
demonstrates that the time taken was unjustifiably long. 
                                                      
1512 It is worth recalling, more generally, that the approval procedures which were completed before 
there was a de facto  moratorium on approvals were not aff ected by the special circumstance that 
Directive 90/220 was repealed in 2002.    
1513 See, e.g., US second written submission, para. 51 (emphasis in original).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 777 
  
  Conclusions
 
7.2040  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that it has not been established 
that the time taken by the lead CA for it s assessment of the application concerning 
LL oilseed rape was unjustifiably long, or that the total period of time during which 
the application concerning LL oilseed ra pe had been pending as of August 2003 
demonstrates that the time taken by the European Communities was unjustifiably 
long.  Based on these findings, the Panel is unable to accept the United States' contention that, consistent with the gene ral moratorium, the European Communities 
failed to consider the application concerni ng LL oilseed rape for final approval, and 
that this resulted in "undue delay" in  the completion of the relevant approval 
procedure.  Accordingly, the Panel conc ludes that in respect of the approval 
procedure concerning LL oilseed rape, the United States has failed to establish that 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
 
(xiii) BXN cotton (EC-73) 
7.2041  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning BXN cotton has been unduly delayed.   
7.2042  The United States argues that the total time taken at the member State level for the initial 
review of this application was over four years, as this product still had not been forwarded to the 
Commission at the time of establishment of the Pane l.  The United States contrasts this with the 90 
days referred to in Directives 90/220 and 2001/18.   The United States contends that although the 
applicant had provided answers to all of the questi ons from the lead CA, the lead CA still failed to 
complete its assessment.  The United States contends that the delays by the lead CA in completing the 
approval procedure concerning BXN cotton are undue. 
7.2043  The United States also points out that the application concerning BXN cotton is one of nine 
applications identified by the United States which ha ve been pending at the member State level for an 
average of three years and ten months.  The United States contends in this respect that although time 
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a 
moratorium on approvals, this delay in completi ng the approval procedure concerning BXN cotton is 
undue.  The United States submits, in addition, th at before the European Communities adopted its 
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less 
than three years. 
7.2044  The European Communities  argues that the time taken by the lead CA was necessary in 
order to ensure a valid safety assessment.  Following receipt of the application, the lead CA requested 
further information from the applicant to address defi ciencies in the application.  Spain's scientific 
committee, the National Biosafety Committee, found th at a considerable amount of information was 
missing on issues such as compositional analysis, e nvironmental impact, toxicity and nutritional 
analysis.  In addition, a number of points required clarification, such as the scope of the application 
and the labelling proposal.  The lead CA requested th is information from the applicant in July 1999.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 778 
  
  7.2045  The European Communities contends that the applicant did not respond to the lead CA's 
request for three years, until January 2003.  At that time, the lead CA was informed of a change in the 
company submitting the application, and the new applicant company submitted an up-dated 
notification in accordance with Directive 2001/ 18.  However, according to the European 
Communities, the new dossier was also incomplete w ith regard to the molecular characterization of 
the product.  The European Communities points out that further information was requested of the 
applicant in October 2003. 
7.2046  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2047  We note that in the approval procedure con cerning BXN cotton, the applicant submitted an 
application to the lead CA (Spain) on 3 May 199 9.  When Directive 90/220 was repealed on 17 
October 2002, the lead CA had not yet forwarded the dossier to the Commission.  On 16 January 
2003, an updated application was submitted following th e entry into force of Directive 2001/18.  At 
the time of establishment of the Panel, this appli cation was still under consideration by the lead CA.   
7.2048  The United States contends that the lead CA took too long to complete its assessment.  It is 
correct that the lead CA took much  more time for its assessment of the application than the 90 days 
envisaged in Directives 90/220 and 2001/18.  Howeve r, we have observed that that deadline was not 
dispositive, per se , of whether the European Communities met its WTO obligation to complete its 
approval procedures without undue de lay.  Moreover, the European Communities contends that much 
of the time taken by the lead CA until August 2003 is  attributable to failures by the applicant to 
promptly provide requested information.  The European Communities submits that without this 
information, it was not possible for the lead CA to complete its assessment and submit a report to the Commission.  We therefore need to examine whethe r the lead CA was justified in not completing its 
assessment by August 2003.   
7.2049  As we noted in our previous consideration of th is application, the record before us is very 
incomplete.  This said, it is clear that within two months of receipt of the application, the Spanish 
National Biosecurity Committee identified a number of concerns with the appl ication, and these were 
communicated to the applicant in July 1999.  Two months later, the applicant provided the 
information requested.  The applicant clarified, inter alia , that the application was both for the import 
and processing of seeds of BXN cotton as well as for the cultivation of BXN cotton.  Following the 
further examination of the application in January 2000 by the Spanish Nati onal Biosafety Committee, 
the lead CA requested further clarifications on so me of the same issues in a communication dated 2 
February 2000.
1514  The applicant did not respond to this request before an updated application was 
submitted in January 2003  under Directive 2001/18.1515 
7.2050  On 15 January 2003, the lead CA was informed of a change in the company pursuing the 
application, and on 16 January 2003 an updated application was submitted under Directive 2001/18 
and completed in March 2003.  It appears that the updated application concerns only the importation 
of seed for processing, but not for cultivation.  In August 2003, when this Panel was established, the 
application appears to have been under review by the National Biosafety Committee.1516  
                                                      
1514 Exhibit EC-73/At. 6. 
1515 This is confirmed by Exhibit EC-73/At. 12. 
1516 There is no information about when the application was submitted to the National Biosafety 
Committee.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 779 
  
  7.2051  It is clear from the foregoing that in this procedure a delay of more than two and a half years 
occurred between February 2000, when the lead CA requested clarifications, and October 2002, when 
Directive 90/220 was repealed.  Based on the informa tion submitted to us, we u nderstand that this gap 
was caused by the failure of the applicant to pr ovide the requested clarifications.  However, the 
precise reasons for the failure of the applicant to respond to the lead CA's February 2000 request are 
unclear.   
7.2052  The United States has not specifically challenged the justifiability of any of the requests for 
additional data or clarifications made by the lead CA .  In the light of the three-year delay in response 
from the applicant following the request in February  2000 for additional information, we asked the 
experts advising us whether the information requested  by the lead CA up to and in February 2000 was 
necessary to ensure that conclusions  of the safety assessment were valid.
1517  The experts noted that 
only the table of contents of the actual submissi on by the applicant had been provided, and the 
response from the applicant.  On the basis of this limited information, Dr. Nutti was of the view that 
the responses provided by the applicant in Septembe r 1999 appeared to be satisfactory as far as food 
safety was concerned.  These responses provided clarif ication or explanations of information that 
presumably was contained in the original application.1518  Dr. Andow noted that the information 
previously requested by the lead CA was nor mally necessary to assess environmental risks, 
particularly those related to the cultivation of the pl ant.  However, without the application itself, he 
could not determine to what extent relevant in formation may have already been provided by the 
applicant, or how much additional information mi ght be necessary.  Dr. Andow further observed that, 
according to the table of contents, only two pages of th e text of the application were devoted to issues 
relating to environmental impact studies, herbicide or  residue toxicity or ecotoxicity tests or proposals 
to manage, monitor and handle the crop to redu ce the risk of herbicide resistance in weeds.1519   
7.2053  Like the experts advising us, we consider that the incomplete information before us does not 
permit us to form a definitive view on whether the cl arifications requested by the lead CA in February 
2000 were justified to ensure that conclusions of the safety assessment were valid and hence on 
whether the resulting three-year delay in the consider ation of the application was justified by the need 
to check and ensure that relevant require ments of Directive 90/220 were fulfilled.  
7.2054  Turning to Spain's assessment of the application concerning BXN cotton under 
Directive 2001/18, we note that the updated notifi cation was submitted to Spain on 16 January 2003.  
It was not until 14 February 2003, i.e., almost one month later, that the lead CA requested the 
applicant to submit a summary of the application as required by Directive 2001/18.  The applicant provided such a summary on 19 March 2003, and thus the updated application appears to have been 
complete as of that date.  The application was apparently forwarded to the National Biosafety 
Committee for an assessment, but as of August 2003 that assessment had not yet been completed.  
The record shows that the assessment was completed in September 2003.
1520   
7.2055  The European Communities offers no justification fo r the time taken by the lead CA to follow 
up with the applicant to request a su mmary of the application.  We are not persuaded that almost a full 
month was required to de termine the completeness of the updated application and forward an 
appropriate request to the applicant.     
                                                      
1517 Annex H, Panel Questions 30 and 31. 
1518 Annex H, para. 601. 
1519 Annex H, paras. 604-612. 
1520 Exhibit EC-73/At. 12.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 780 
  
  7.2056  Furthermore, with regard to the time taken by  the lead CA to assess the application once it 
had been completed by the applicant in March 2003, we  recall that in accordance with Article 14(2) of 
Directive 2001/18, the lead CA should have prepared  an assessment report within 90 days.  The 90 
days do not include any periods of time during wh ich the lead CA is awaiting further information 
which it requested from the applicant.  In the pr esent case, the record shows that the lead CA 
requested additional information only in October 2003.
1521  Thus, the lead CA should have completed 
its assessment at the latest 90 days after 19 Marc h 2003, which is the date on which the applicant 
completed its updated application.  However, as of  August 2003, the lead CA had still not completed 
its assessment.  Thus, as of 29 August 2003, the lead CA  had already taken more than five months to 
assess the application, and first request for additio nal information was forwarded more than a month 
later.   
7.2057  As we have said, the question of whether or not the lead CA complied with the 90-day 
deadline stipulated in Directive 2001/18 is not dispositive, per se , of whether the European 
Communities met its WTO obligation to complete its approval procedures without undue delay.  
However, as we have also noted earlier, the deadline set forth in Directive 2001/18 nonetheless 
provides a useful indicator to guide the Panel's analysis.  The 90-day deadline is binding and applies to all relevant applications submitted under that Dir ective.  It may therefore be assumed that the EC 
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member 
States to assess even complex applications  within the prescribed deadline.    
7.2058  The European Communities provides no justificati on for the time taken by the lead CA in 
excess of the 90-day period, other than the assertion that the updated application was incomplete with 
regard to the molecular characterization of the product.   It is correct that the lead CA in October 2003 
requested additional information, including on mole cular characterization of the product.  However, 
we are not convinced that more than five months were needed to identify this and other substantive 
shortcomings in the updated application.   
7.2059  From the record of the consideration of this application by the National Biosafety Committee, 
it is clear that th e Committee had also been reviewing the applications concerning Bt-531 cotton and 
RR-1445 cotton, for which Spain was also the lead  CA.  However, we recall that pursuant to 
Directive 2001/18, the lead CA was to  prepare an assessment report within  90 days after receipt of an 
application.  It should also be noted in this  connection that the National Biosafety Committee's 
assessment concerning BXN cotton is quite short, i.e., there is no indication that the preparation of the 
Committee's assessment required much time.  Additionall y, we note that the lead CA in this case was 
not examining the application concerning BXN cotton fo r the first time.  While it is true that the lead 
CA in 2003 had to undertake an assessment in ac cordance with the partly new requirements of 
Directive 2001/18, it seems equally clear that the pr ior assessments rendered the lead CA's task less 
complex than it would have been if the lead CA ha d had to undertake an assessment of the application 
for the first time.   
7.2060  Taking account of the foregoing elements, we cons ider that the lead CA could and should 
have acted more promptly than it did when it rece ived an updated, but incomplete, application in 
January 2003 and subsequently, when the appli cant submitted the missing summary in March 2003.  
Accordingly, we conclude that the time taken by the lead CA up to August 2003 for its assessment of 
the application concerning BXN cotton under Directive 2001/18  was unjustifiably long. 
7.2061  In addition, we recall that the United States claims that the approva l procedure concerning 
BXN cotton was unduly delayed because, due to the moratorium, the European Communities failed to 
                                                     
 
1521 Exhibit EC-73/At. 13.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 781 
  
  consider the application in question for final appr oval.  In this respect, we note our earlier findings 
that (i) a general de facto  moratorium on approvals was in e ffect in the European Communities 
between June 1999 and August 2003 and that (ii) the time taken by Spain to assess the application 
concerning BXN cotton under Directive 90/220 and subsequently under Directive 2001/18 is 
consistent with the application of such a moratori um.  In the light of this, and in the absence of 
effective rebuttal by the European Communities, we agree with the United States that it is reasonable 
to infer that Spain's conduct after the entry into force of Directive 2001/18 was a consequence of the 
general moratorium on approvals.  
7.2062  In view of our conclusion with regard to th e time taken by Spain for its assessment, we do not 
go on to examine other arguments put forward by  the United States in support of its claim under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusions
 
7.2063  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning BXN cotton under Directive 2001/18 was unjustifiably long, and that it can reasonably be inferred from 
surrounding circumstances that the lead CA's conduct was a consequence of the 
general moratorium on approvals.  Base d on these findings, the Panel accepts the 
United States' contention that, consistent w ith the general moratorium, the European 
Communities failed to consider the app lication concerning BXN cotton for final 
approval, and that this resulted in "undue delay" in the completion of the relevant 
approval procedure.  Accordingly, the Panel concludes that in respect of the approval 
procedure concerning BXN cotton, the European Communities has breached its 
obligations under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement . 
 
(xiv) Bt-1507 maize (EC-74) 
7.2064  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Bt-1507 maize (EC-74) has been unduly delayed.   
7.2065  The United States argues that the application concerning Bt-1507 maize (EC-74) was 
delayed at the member State level.  The United States submits that although the applicant provided answers to all of the questions, the lead CA nonethel ess delayed its considerati on of the product.  The 
United States explicitly contests the justifiability of one of the information requests by the lead CA, as 
well as of a number of the objections raised by other member States following the circulation of the 
application by the Commission. 
7.2066  The United States also points out that the app lication concerning Bt-1507 maize (EC-74) is 
one of nine applications identified by the United States which have been pending at the member State 
level for an average of three years and ten months.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Bt-1507 maize (EC-74) is undue.  The United States s ubmits, in addition, that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 782 
  
  7.2067  The European Communities  argues that the time taken by the lead CA was necessary in 
order to ensure a valid safety assessment.  Exch anges between the lead CA and the applicant 
regarding data relating to molecular characterizati on, allergenicity, toxicity of CRY1F and labelling 
went on until late 2002.  In two instances, the app licant requested an extension of the time granted by 
the lead CA to submit further data or information.  The applicant upda ted the notification just after the 
entry into force of Directive 2001/18.  After a fu rther exchange on compositional data, a monitoring 
plan, and confidentiality of the detection method, the lead CA submitted the full application and its 
assessment report to the Commission in August 2003.   The European Communities observes that once 
the application reached the Community level, a c onsiderable number of objections were raised by 
member States, including on environmental effects, the monitoring plan, molecular characterisation, 
sampling and detection methods, a llergenicity and toxicity.   
7.2068  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2069  We recall that in the approval procedure c oncerning Bt-1507 maize (EC-74), the applicant 
submitted an application to the lead CA (t he Netherlands) on 23 No vember 2000.  When 
Directive 90/220 was repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission.  The dossier wa s forwarded to the Commission with  a favourable assessment report 
on 15 August 2003, after the applicant had provide d an updated application in accordance with 
Directive 2001/18.   
7.2070  The United States contends that the lead CA took too long to complete its assessment.  On the 
other hand, the European Communities contends that all of the time taken by the lead CA until August 
2003 when the lead CA forwarded its assessment report to the Commi ssion was necessary to resolve 
scientific and technical issues.  It therefore needs to  be examined whether the lead CA was justified in 
forwarding an assessment report to the Commission only in August 2003.   
7.2071  As we noted previously, there was frequent communication between the lead CA and the 
applicant on this product from the initial applicati on on 23 November 2000 until the lead CA sent its 
assessment report to the Commission on 15 August 2003 .  The United States explicitly challenges the 
justifiability of only one of the requests for additi onal data made by the lead CA, namely, the lead 
CA's follow-up request of 13 December 2001.  We recall that in response to a March 2001 request 
from the lead CA the applicant on 16 October 2001 provided field trials from Chile, France and Italy, 
which it considered representative for the cultiv ation areas exporting maize to the European 
Communities.
1522  Yet on 13 December 2001 the lead CA indicated that it was not convinced by the 
response and maintained its request.  Specifically, the lead CA indicated that it was not convinced that 
these locations would be representative of locations exporting maize to the European Communities.  It 
therefore requested that the applicant conduct add itional field trials and pr ovide compositional data 
for two consecutive growing seasons.1523   
7.2072  The applicant addressed this further request for additional field trials in its responses of 21 
November 2002.  It provided arguments as to why the results of the field trials for 1998/1999 from Chile, France and Italy should be considered to be sufficient, and also submitted the results of field 
trials for 1999/2000 from Bulgaria, France and Italy.
1524  On 10 February 2003, the lead CA indicated 
that it accepted this response, but requested that th e data provided from the field trials in Chile be 
                                                      
1522 Exhibit EC-74/At. 33. 
1523 Exhibit EC-74/At. 52. 
1524 Exhibit EC-74/At. 65, response to Panel Question 3.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 783 
  
  presented in the same detail and manner as fo r France and Italy, and suggested a format.
1525  This was 
apparently done by the applicant on 24 March 2003.1526 
7.2073  The United States argues that when the lead CA on 13 December 2001 rejected the applicant's 
compositional data from field trials that had been conducted in France, Italy and Chile, on the grounds 
that these locations were insuffici ently representative of locations exporting maize to the European 
Communities, the lead CA provided no explanati on for its conclusion that the locations were 
"insufficiently representative."  The United States ar gues that the data provided by the applicant in 
October 2001 would generally be c onsidered "representative" and re levant for evaluating maize that 
might be imported into the European Communities.  The United States maintain s that, in the absence 
of some further explanation, such as an anomaly in the submitted data, the only explanation for the 
lead CA's request for additional field trials of  13 December 2001 appeared to be the resulting two-
year delay caused by the time it would take for the applicant to generate the data.   
7.2074  Even assuming that the additional field trials we re not necessary, we note that the applicant's 
response of 21 November 2002 was provided together  with responses to a request of March 2002 for 
other additional information which has not been ques tioned by the United States.  It is therefore not 
clear that the delay in the consideration of the a pplication until 21 November 2002 is attributable to 
the request for additional field trials.    
7.2075  At any rate, we note that on 21 November 2002 the applicant also updated its application in 
the light of the new requirements of Directive 2001/ 18.  This resulted in the lead CA requesting 
further information from the applicant on 10 February 2003 with respect to a surveillance plan and the 
confidentiality of the proposed detection method.  Fu rthermore, as noted, in February 2003 the lead 
CA dropped its request for the additional field trials , but requested that the data be presented in a 
uniform manner.  The responses to these requests were  provided by the applic ant on 24 March 2003, 
and on 28 May 2003 the applicant withdrew the re quest for confidentiality with respect to the 
detection method. 
7.2076  In the light of the foregoing, we consider that  by the end of March 2003 the lead CA had all 
the elements to complete its safety assessment.  The outstanding clarification of the confidentiality 
issue should not have delayed the completion of the sa fety assessment itself.  In any event, as we have 
noted, the confidentiality issue was resolved in May 2003.  Notwithstanding this, the lead CA did not 
send its completed assessment report to the Commission until 15 August 2003.   
7.2077  We recall that in accordance with the require ments of Directive 2001/18 the lead CA was to 
have transmitted its completed assessment report at  the latest 90 days after receipt of the updated 
application.  As we have already pointed out, fo llowing the receipt of the application in November 
2002, the lead CA reviewed the application for more than two and a half mont hs before forwarding its 
request for additional information.  After receivi ng the applicant's response in March 2003, the lead 
CA took an additional period of time of more than f our and a half months to complete its assessment 
report and transmit it to the Commission.  Thus, by the time the lead CA sent its assessment report to 
the Commission it had taken more than seven months to evaluate the updated application instead of 
the 90 days envisaged in Directive 2001/18.   
7.2078  We have observed earlier in respect of the 90-day deadline stipulated in Directive 2001/18 
that that deadline provides a useful indicator for determining how much time might be needed to 
complete an assessment.  As we have said, in the case of the application concerning Bt-1507 maize 
                                                      
1525 Exhibit EC-74/At. 84. 
1526 Exhibit EC-74/Ats. 87-88. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 784 
  
  (EC-74), by the end of March 2003 the lead CA ha d all the elements to complete its safety 
assessment.  If the lead CA at that point in time had taken a full 90-day period to complete its assessment, it would have completed its assess ment before the end of June 2003.   
7.2079  The European Communities has offered no justif ication for the time taken by the lead CA 
between March and August 2003.  It is pertinent to note in this respect that the lead CA in 2003 was 
not examining the application concerning Bt-1507 ma ize (EC-74) for the first time.  While it is true 
that the lead CA in 2003 had to undertake an  assessment in accordance with the partly new 
requirements of Directive 2001/18, the lead CA had already spent two and a ha lf months assessing the 
application in question.  Moreover, it seems clear that the lead CA's prior assessment of the same 
application under Directive 90/220 rendered the lead  CA's task considerably less complex than it 
would have been if the lead CA  had had to undertake an assessment for the first time.  Yet 
notwithstanding this, even when the lead CA had al l the necessary information, it failed to complete 
and transmit its assessment report within 90 days.  
7.2080  Thus, even if we were to accept that it was le gitimate for the lead CA to insist on the 
confidentiality issue being resolved before it tran smitted its assessment report to the Commission, in 
the light of the generally applicable 90-day period  stipulated in Directive 2001/18, and in the absence 
of any justification offered by the European Comm unities, we are not convinced that the lead CA 
could not have completed and transmitted its assess ment report considerably earlier than mid-August 
2003.  Hence, taking account of the aforementioned el ements, we consider that the lead CA should 
have transmitted its assessment report to the Commission more promptly than it did.   
7.2081  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning Bt- 1507 maize (EC-74) – notably the time taken by the 
lead CA after May 2003, when the applicant withdr ew the request for confidentiality with respect to 
the detection method – was unjustifiably long. 
7.2082  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning Bt-1507 maize (EC-74) was unduly delayed because, due to the moratorium, the European Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and A ugust 2003 and that (ii) the failure of the Netherlands to 
complete its assessment of the application concer ning Bt-1507 maize (EC-74) earlier than in August 
2003 is consistent with the application of such a mo ratorium.  In the light of this, and in the absence 
of effective rebuttal by the European Communitie s, we agree with the United States that it is 
reasonable to infer that the Netherlands' conduct was a consequence of the general moratorium on 
approvals.  
7.2083  In view of our conclusion with regard to the time taken by the Netherlands for its assessment, 
we do not go on to examine other arguments put forw ard by the United States in support of its claim 
under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusion
 
7.2084  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the applicati on concerning Bt-1507 maize (EC-74) was  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 785 
  
  unjustifiably long, and that it can reasonably be inferred from surrounding 
circumstances that the l ead CA's conduct was a consequence of the general 
moratorium on approvals.  Based on these findings, the Panel accepts the United 
States' contention that, consistent with the general moratorium, the European 
Communities failed to consider the application concerning Bt-1507 maize (EC-74) for final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning Bt-1507 maize (EC-74), the European Communities 
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
 
(xv) Bt-1507 maize (EC-75) 
7.2085  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Bt-1507 maize (EC-75) has been  unduly delayed.  To recall, this application 
concerns the same product as above, however it wa s submitted to Spain and concerns the cultivation 
of the product.  The previous application was for processing, food and feed use, but not for 
cultivation.  
7.2086  The United States argues that the application concerning Bt-1507 maize (EC-75) was 
delayed at the member State level..  The United St ates submits that although the applicant provided 
answers to all of the questions, the lead CA none theless delayed consideration of the product.  The 
United States also contests the justifiability of some  of the information requested by the lead CA, and 
particularly of a number of the objections raised  by other member States following its circulation by 
the Commission.    
7.2087  The United States also points out that the app lication concerning Bt-1507 maize (EC-75) is 
one of nine applications identified by the United States which have been pending at the member State 
level for an average of three years and ten months.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Bt-1507 maize (EC-75) is undue.  The United States s ubmits, in addition, that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years.   
7.2088  The European Communities  argues that the time taken by the lead CA was necessary in 
order to ensure a valid safety assess ment.  The European Communities  argues that following a 
preliminary assessment of this application by the Spanish National Biosafety Committee, the lead CA 
requested further data relating to molecular charact erization, allergenicity and toxicity of CRY1F, 
environmental impact and a monitoring plan.  These requests were dealt with by the applicant during 
the following 12 months, until 17 July 2002.
1527  After the entry into force of Directive 2001/18, the 
applicant updated the application in line with the requirements of the new legislation.  Exchanges 
between the applicant and the lead CA continued until the 28 May 2003.  The lead CA submitted the 
full application and its assessment report to the Commission on 5 August 2003.   
7.2089  The European Communities further observes that once the application reached the 
Community level, a considerable number of objecti ons were raised by member States, including on 
the monitoring plan, molecular characterization,  effects on non-target organisms, toxicity, 
allergenicity, and detection methods.   
                                                      
1527 Exhibit EC-75/Ats. 1-3. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 786 
  
  7.2090  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2091  We recall that following the receipt of the a pplication concerning Bt-1507 maize (EC-75), the 
lead CA (Spain) consulted with its National Bio safety Committee, which took more than two and a 
half months to review the application.  The lead CA then waited over a month, until 30 October 2001, 
before requesting additional in formation from the applicant based  on the advice received from the 
Committee.  This request was a pparently repeated in a communi cation of 28 November 2001.  A 
response was provided by the applicant on 14 February 2002.  Once again, the lead CA consulted with 
the National Biosafety Committee.  The Committ ee took three months to review the additional 
information submitted in February 2002.  As it had done previously, the lead CA waited over a 
month, until 17 June 2002, before submitting anothe r request for additional information to the 
applicant.  The applicant responded to these request s on 17 December 2002.  This was after the date 
of repeal of Directive 90/220. 
7.2092  Even assuming that the October/November 2001 and June 2002 requests were necessary to 
ensure that the conclusions of the safety assessment were valid, we recall that in accordance with the 
requirements of Directive 90/220 the lead CA was to have completed its assessment at the latest 90 
days after receipt of the application concerning Bt -1507 maize (EC-75).  As we have already pointed 
out, following the receipt of the application in July 2001, the lead CA exceeded the 90-day period even before it submitted its initial request for additiona l information to the applicant.  Of particular 
concern in this connection is the circumstance th at the lead CA waited for more than one month 
before forwarding the questions suggested by the National Biosafety Committee in September 2001.   
7.2093  The European Communities has offered no justifica tion for the time taken by the lead CA to 
transmit the October/November 2001 request for additi onal information.  We note that the time taken 
by the lead CA in this instance contrasts with other approval procedures where Spain was also the 
lead CA and where the Spanish CA forwarded re quests for information from the National Biosafety 
Committee more promptly.
1528  Furthermore, we note that the lead CA did not modify the questions 
suggested by the National Biosafety Co mmittee, but simply forwarded them.  
7.2094    We recognize that the application in this  case was submitted and acknowledged just fifteen 
months before the date of repeal of Directive 90/22 0.  However, we do not consider that in September 
2001, when the lead CA received the suggested qu estions from the National Biosafety Committee, the 
lead CA could have legitimately concluded that it was impossible to complete the required steps and 
have the application approved or rejected while Directive 90/220 was still in force.   
7.2095  Taking account of the aforementioned elements, we  consider that the lead CA could, and 
should, have forwarded the questions suggested by the National Biosafety Committee in September 
2001 more promptly than it did.   
7.2096  We recall that in May 2002 the lead CA recei ved a further suggested request for additional 
information from the National Biosafety Committee.   The lead CA again waited for over a month 
before forwarding the request in June 2002, even though it did not modify the Committee's request.   
7.2097  We recognize that May 2002 was relatively close to the date of repeal of Directive 90/220.  
However, even if we were to accept, arguendo , that the application could not go through the required 
steps before the repeal of Directive 90/220, in our vi ew, this would not have justified the lead CA in 
                                                      
1528 See, e.g., the approval procedure concerning BXN cotton.  Exhibit EC-73/Ats.  2-3 and 5 and 6.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 787 
  
  delaying the transmission of the new request for information.  We note in this regard that 
Directive 2001/18 entered into force in Octobe r 2002.  If the application submitted under 
Directive 90/220 remained incomplete or required furt her clarification, knowledge of this would have 
assisted the applicant in correcting any deficien cies and submitting an updated, more complete 
application soon after the entry into force of Directive 2001/18.
1529 
7.2098  Therefore, as with the previously discussed de layed transmission of a request for additional 
information, we consider that the lead CA could,  and should, have forwarded the Committee's request 
more promptly than it did.    
7.2099  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning Bt- 1507 maize (EC-75) – notably the time taken by the 
lead CA to forward questions from the Nationa l Biosafety Committee – was unjustifiably long. 
7.2100  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning Bt-1507 maize (EC-75) was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its 
assessment of the application concerning Bt-15 07 maize (EC-75) earlier than in August 2003 is 
consistent with the application of such a moratori um.  In the light of this, and in the absence of 
effective rebuttal by the European Communities, we agree with the United States that it is reasonable 
to infer that Spain's conduct was a consequen ce of the general moratorium on approvals.  
7.2101  In view of our conclusion with regard to th e time taken by Spain for its assessment, we do not 
go on to examine other arguments put forward by  the United States in support of its claim under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusion  
7.2102  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the applicati on concerning Bt-1507 maize (EC-75) was 
unjustifiably long, and that it can reasonably be inferred from surrounding 
circumstances that the l ead CA's conduct was a consequence of the general 
moratorium on approvals.  Based on these findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Communities failed to consider the application concerning Bt-1507 maize (EC-75) for final approval, and that this resulted in "undue delay" in the completion of the 
                                                     
 
1529 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force, 
there was no realistic prospect that the Group of Five countries and the Commission would allow the final 
approval of the application in question.  However, the Pane l does not consider that this would have justified the 
time taken by Spain to forward the questions suggested by the National Biosafety Committee.  Spain might have anticipated opposition from the Group of Five countries on the basis of their June 1999 declaration.  As pointed 
out above, notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to 
approve applications.  The same is true for the Commission, which had not issued a declaration comparable to that of the Group of Five countries.    
  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 788 
  
  relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning Bt-1507 maize (EC-75), the European Communities has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
 
(xvi) NK603 maize (EC-76)   
7.2103  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning NK603 maize has been unduly delayed. 
7.2104  The United States  argues that the application was delayed at the first stage of the approval 
process under 90/220 because the lead CA declined to  forward the application to the Commission.  
Although the applicant provided answers to all of the questions raised by the lead CA, the lead CA 
nonetheless delayed this product under Directive 90/220.  The application remained at member State 
level for a period of 25 months.  This product was resubmitted under Directive 2001/18, and received 
favourable initial assessme nts from the Spanish CA. 
7.2105  The United States also points out that the application concerning NK603 maize is one of nine 
applications identified by the United States which ha ve been pending at the member State level for an 
average of three years and ten months.  The United States contends in this respect that although time 
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a 
moratorium on approvals, this delay in completi ng the approval procedure concerning NK603 maize 
is undue.  The United States submits, in addition, th at before the European Communities adopted its 
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less 
than three years.  
7.2106  Argentina  notes that a risk assessment of NK603 maize was initiated under Directive 90/220 
and re-initiated under Directive 2001/18.  This wa s concluded with a favour able opinion from the 
scientific panel.  Argentina notes that, as of April 2004, the approval procedure concerning NK603 
maize, which was initiated on 4 August 2000, had last ed 3 years and 8 months and no final decision 
had been reached on the application for approval. 
7.2107  The European Communities  claims that the only delays in  the application for NK603 maize 
arose due to questions on additional information;  otherwise the application process has proceeded 
smoothly.  In addition, the European Communities asserts that the application submitted in August 
2000 was incomplete and therefore not considered  as received until January 2001.  The European 
Communities further claims that 44 days after th e application was submitted, the clock was stopped 
because the scientific committee of the lead CA re quested additional information on issues such as 
molecular characterization, nutritional composition, and environmental impact.
1530 
7.2108  The United States  notes that using the January 2001 date of receipt suggested by the 
European Communities, and taking account of the "clock stop" when requested information was 
awaited from the applicant, out of the total 25 months  for which the application was at the CA level, 
the European Communities had delayed action on the application for NK603 maize under Directive 90/220 for 12 months.   
7.2109  The European Communities  responds that, given that the applicant had taken 13 months to 
gather additional information, it was not unreasonable that the lead CA required 12 months to digest 
and process that information.   
                                                     
 
1530 Exhibit EC-76/At. 1.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 789 
  
  7.2110  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at the member State level
 
7.2111  We recall that the applicant sent the first app lication to the Spanish CA on 4 August 2000.  
Four months later, on 20 December 2000, the appli cant resubmitted the application in Spanish and 
apparently with additional st udies added to the application.1531  We note that there is no record of 
these additional studies.  The Spanish CA acknowledge d receipt of the information in a letter of 2 
January 2001. 
7.2112  The record shows that the lead CA requested  additional information in February 2001, 
October 2001 and May 2002.1532  The progress of the application was adversely affected notably by 
the February and October 2001 requests, in that the a pplicant took more than six months to respond to 
the February 2001 request and more than five months to respond to the October 2001 request. 
7.2113  We recall that we asked the expe rts advising us whether the information requested by the lead 
CA in February 2001 was necessary to ensure th at conclusions of the product's safety assessment 
were valid.  Dr. Nutti concluded that the furt her studies requested were not necessary for the 
assessment of the safety of NK603 as a food.  Furthermore, given that the application was for import and use in the European Communities and not for cu ltivation, Dr. Andow concluded that requests for 
additional detailed environmental studies were not justified, alt hough some information relating to 
potential adverse effects of spillage could be c onsidered reasonable.  The European Communities 
submits that the expert replies with respect to  the food safety studies were based on the mistaken 
premise that certain studies had already been pr ovided, which the Europ ean Communities argues was 
not the case.  We note that on the basis of the information provided to us, we cannot determine 
whether or not such information had been previously provided.
  
7.2114  Turning to the October 2001 request for additi onal information, we note that this request 
concerned additional information which the Sp anish CA emphasized was "essential for product 
traceability".  Further details were also requested on the potential environmental impact of accidental 
dissemination or germination.  When the appli cant provided the additional information requested 
more than five months later, in March 2002, the applicant stressed that the conclusion provided in 
relation to safety was not altered by the new studi es that had been request ed.  In response to a 
question from the Panel regarding this second requ est for information, Dr. Andow noted that 
information on the potential environmental impact of accidental release could be useful to the lead 
CA, but also observed that the lead CA could ha ve been more specific regarding its particular 
concerns.1533 
7.2115  Even if we were to accept that  all of the information requested  by the lead CA in February 
and October 2001 and in May 2002 was necessary to en sure the validity of the safety assessment, it is 
apparent from the record that the lead CA in th is approval procedure exceeded the maximum period 
of 90 days envisaged in Directive 90/220 for a lead CA assessment.  Between January 2001 and 
August 2002, when the applicant of its own motion updated its application in accordance with the 
requirements of Directive 2001/181534, the lead CA spent six and a half months evaluating the 
application without finishing its assessment report.  This is more than twice the length of time 
established in Directive 90/220. 
                                                      
1531 Exhibit EC-76/At. 3. 
1532 Exhibit EC-76/Ats. 6, 10 and 14, respectively. 
1533 Annex H, Dr. Andow's response to Panel Question 38. 
1534 Exhibit EC-76/Ats. 15 and 18. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 790 
  
  7.2116  Specifically, the lead CA initially took one and a half months to assess the application before 
it forwarded the February 2001 requ est for additional information.
1535  Subsequently, the lead CA 
reviewed the application for over one month befo re it transmitted its October 2001 request for 
additional information.1536  Then, the lead CA spent just under two months prior to sending its last 
request for additional in formation in May 2002.1537  The applicant responded to this last request in 
June 2002.  However, the lead CA did not comple te its assessment in the following two months, i.e., 
prior to the end of August of 2002, when the applicant updated its application based on the new 
requirements of Directive 2001/18.  This is despite th e fact that at its meeting of 11 July 2002, the 
Spanish scientific body assessing the application,  the National Biosafety Committee, recommended 
for adoption a favourable report on the application.1538   
7.2117  As we have said before, we recognize that the question of whether or not the lead CA 
complied with the 90-day deadline stipulated in Directive 90/220 is not dispositive, per se , of whether 
the European Communities met its WTO obligation to complete its approval procedures without 
undue delay.  However, we have also said that the deadline set forth in Directive 90/220 provides a 
useful indicator to guide the Panel's analysis.  The 90-day deadline is binding and applies to all relevant applications s ubmitted under that Directive.  It may therefore be assumed that the EC 
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member 
States to assess even complex applications  within the prescribed deadline.    
7.2118  The European Communities provides no justificati on for the time taken by the lead CA in 
excess of the 90-day period, other than the assertion that the time taken by the lead CA was not 
unreasonable in view of the need to digest and pr ocess the information provided by the applicant.  
While we agree that the lead CA needs to be able to "digest and process" information provided at its 
request, it is clear from Directive 90/220 that the EC legislator considered that 90 days was a 
reasonable period of time within which to do so.  Also, the European Commun ities does not argue that 
in the case at hand the replies and documents provided by the applicant at the lead CA's request were 
particularly voluminous or complex, such that more  than double the amount of time was required than 
the maximum amount of time Directive 90/220 allows lead CAs for the assessme nt of applications.  
From a review of the relevant documents, it is not apparent to us that they are any more voluminous 
or complex than others on the record which concern different applications. 
7.2119  We have previously pointed out that Spain was part of the Group of Seven countries which 
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with 
applications for the placing on the market of biotech  products.  However, in this instance, we are not 
convinced that the Spanish CA's conduct reflects a precautionary approach.  Notably, we are not 
convinced that the Spanish CA could not have id entified its needs for additional information and 
forwarded appropriate requests for information to  the applicant sooner than it did, even while 
following a precautionary approach.   
7.2120  Moreover, we do not think that there was insuffi cient time to complete the approval procedure 
while Directive 90/220 was still in force.  We note th at as of July 2002, the lead CA had all necessary 
information, including positive scientific advice fro m the National Biosafety Committee, to complete 
its assessment.  We recognize that as of July 2002 there was not much time left to complete the 
approval procedure under Directive 90/220.  However, if Spain had proceeded more rapidly at earlier 
stages in the procedure, there would certainly have  been enough time for the other member States to 
                                                     
 
1535 Exhibit EC-76/Ats. 4 and 5. 
1536 Exhibit EC-76/Ats. 7 and 10. 
1537 Exhibit EC-76/Ats. 11 and 14. 
1538 Exhibit EC-76/At.  17.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 791 
  
  review the lead CA's assessment report within 60 days following the circulation of the assessment 
report and, in the absence of objections, for the l ead CA to give its consent to the placing on the 
market of NK603 maize.
1539  As indicated above, we consider that Spain could have identified its 
needs for additional information and forwarded a ppropriate requests for information sooner than it 
did, particularly prior to forwarding its request for information of May 2002.   
7.2121  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning NK603 ma ize – notably the time taken by the lead CA up 
to August 2002, when the applicant updated its a pplication in accordance with the requirements of 
Directive 2001/18 – was unjustifiably long. 
7.2122  In relation to DS291, we recall that the United States claims that the approval procedure 
concerning NK603 maize was unduly delayed because,  due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its 
assessment of NK603 maize earlier than in January 2003 is consistent with the application of such a 
moratorium.  In the light of this, and in th e absence of effective rebuttal by the European 
Communities, we agree with the Un ited States that it is reasonable to infer that Spain's conduct was a 
consequence of the general moratorium on approvals.  
7.2123  In view of our conclusion with regard to th e time taken by Spain for its assessment, we do not 
go on to examine other arguments put forward by th e United States and Argentina in support of their 
claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .    
Conclusions  
7.2124  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the applicati on concerning NK603 maize was unjustifiably 
long, and that it can reasonably be inferred from surrounding circumstances that the lead CA's conduct was a consequence of th e general moratorium on approvals.  Based 
on these findings, the Panel accepts the United St ates' contention that, consistent with 
the general moratorium, the European Comm unities failed to consider the application 
concerning NK603 maize for final approval, and that this resu lted in "undue delay" in 
the completion of the relevant approval pro cedure.  Accordingly, the Panel concludes 
that in respect of the approval proce dure concerning NK603 maize, the European 
Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement . 
                                                     
 
1539 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force, 
there was no realistic prospect that the Group of Five countries and the Commission would allow the final 
approval of the application in question.  However, the Pa nel does not consider that this would have justified 
Spain's failure to forward an assessment report to the Commission prior to the date of repeal of Directive 90/220.  Spain might have anticipated opposition from the Group of Five countries on the basis of 
their June 1999 declaration.  As pointed out above, notwithstanding this declaration, the Group of Five countries 
retained the freedom under EC law to approve applications.  The same is true for the Commission, which had not issued a declaration comparable to that  of the Group of Five countries.    
 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 792 
  
   
 (ii) DS293 (Argentina)  
  With reference to DS293, the Panel recalls its finding that the time taken by the lead 
CA for its assessment of the applicati on concerning NK603 maize was unjustifiably 
long.  In the light of this finding, the Panel concludes that the European Communities failed to complete the approval procedure concerning NK603 maize without "undue delay", thus breaching its obligations under Annex C(1)(a), first clause, and Article 8 
of the SPS Agreement . 
 
(xvii)  GA21 maize (EC-78) 
7.2125  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning GA 21 maize (EC-78) has been unduly delayed.  
7.2126  The United States  argues that even though GA21 maize (EC-78) was forwarded by the lead 
CA to the Commission with a favourable opinion, received a positive opinion from the SCP in September 2000, the consultations w ith relevant member States were completed, and the scope of the 
application was reduced to exclude cultivation, th e Commission failed to submit a draft measure to 
the Regulatory Committee.  The United States argue s that there was no action or communication by 
the Commission on this application.  The United Stat es adds that the only activity that occurred after 
the SCP's positive opinion was efforts by the applicant to re-start the process, including the applicant's 
voluntary offer in September 2001 to update the app lication (in the form of undertakings) to the 
requirements of the impending Directive 2001/18.  Furthermore, the United States argues that 
although the applicant submitted all necessar y supplementary information according to 
Directive 2001/18 to the lead CA on 15 January 20 03, no action was taken in the following eight 
months, either by the lead CA or the Commission,  to move the product towards consideration by the 
Regulatory Committee.  
7.2127  The United States submits, finally, that the a pplication concerning GA21 maize (EC-78) is 
one of nine applications identified by the United St ates which were stalled at the Commission level at 
the time Directive 90/220 expired and which, as of th e date of establishment of the Panel, have been 
pending for an average of six and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
GA21 maize (EC-78) is undue.  The United States further argues that before the European Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.2128  Argentina argues that once the SCP issued its favourable opinion on 22 September 2000, the 
procedure on this application was suspended.  Two years and two months had elapsed between the 
submission of the application and its suspensi on. Upon the replacement of Directive 90/220 by 
Directive 2001/18, the application had to be re-s ubmitted.  However, the approval process has not 
made any progress since that time.  One year and eight months elapsed from the re-submission until September 2003, when the application was withdrawn.   In total, counting the time that elapsed under 
Directives 90/220 and 2001/18, the procedure dr agged on for 5 years and 2 months without a 
definitive response concerning approval.    
7.2129  The European Communities  argues that after assessment at both member State and 
Community level, the application was withdraw n by the applicant on 15 September 2003.  The 
European Communities notes that the applicant, in its withdrawal letter, gave three reasons for the  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 793 
  
  withdrawal:  first, the progress in the notification procedure of another Roundup Ready maize to a 
more advanced stage than the GA21 maize (EC-78) notification;  second , the introduction of the new 
regulations concerning commercialisation of GM products in the European Communities;  and third , 
the change of the company's commercial priorities.   
7.2130  Argentina  responds that although the applicant's letter of withdrawal does not have a specific 
reference to "undue delay", this does not imply that no "undue delay" occurred.  Argentina considers 
that the silence of the applicants cannot be take n as evidence of satisfaction with the process, but 
rather that it was due to the applicant's concer n with maintaining good relations with the approving 
authorities.   
7.2131  The Panel  begins its analysis by addressing the de lay allegedly caused by the Commission.   
Failure by the Commission to submit a draft measure to the Regulatory Committee
 
7.2132  We recall that the SCP issued a favourable opinion on 22 September 2000.  Following the 
issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory 
Committee until Directive 90/220 was repealed in October 2002.  The United States and Argentina 
argue that the Commission should have submitted a draft measure to the Regulatory Committee before October 2002.  The European Communities argues that the application was being assessed 
according to the procedures.   
7.2133  We recall that according to the procedures set out in Directive 90/220, after the issuance of 
the SCP opinion, it was for the Commission to s ubmit a draft measure to the Regulatory Committee 
for a vote.  The Commission did not do so, howe ver.  Indeed, it seems that unlike in other 
procedures
1540, the Commission in this procedure never launched inter-service consultations on a draft 
measure.  We are therefore not pe rsuaded by the European Communiti es' assertion that the application 
concerning GA21 maize (EC-78) was being assessed according to the procedures.   
7.2134  At any rate, we observe that the preparation by the Commission of a draft measure and its 
submission to the Regulatory Committee is not a process which inherently takes more than two years.  
In other approval procedures, the Commission was ab le to prepare and submit draft measures to the 
Regulatory Committee within a matter of a few mont hs.  For example, in the procedure concerning 
Bt-531 cotton, the Commission prepared a draft measure and launched a vote in the Regulatory Committee in less than three months.
1541  It may be inferred from this that the Commission could in 
principle have submitted a draft measure to th e Regulatory Committee well before October 2002.   
7.2135  The fact that the Commission could in prin ciple have submitted a draft measure to the 
Regulatory Committee before October 2002 does not necessarily mean that the Commission could have done so in the specific circumstances of this case.  We note in this respect that the SCP's 
favourable opinion stated that "[t]he applicant should however establish a monitoring plan to identify unexpected and unusual events and analyse grower e xperiences, in order to  develop and implement 
any necessary changes in crop management practices in response to the results of monitoring."
1542  
However, as with the approval procedures we have considered earlier, there is no evidence that the 
Commission or the lead CA ever requested the a pplicant to propose a monitoring plan in accordance 
with the SCP's opinion.  In January 2003, the a pplicant submitted an updated application, including a 
monitoring plan.  But this information was submitted at the applicant's initiative, in anticipation of the 
                                                      
1540 See, e.g. , Exhibits EC-62/At. 76; EC-65/At. 48. 
1541 Exhibit EC-65/Ats. 48 and 51.   
1542 Exhibit EC-78+85/At.  90. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 794 
  
  entry into force of the new requirements cont ained in Directive 2001/18, and not because the 
applicant was requested to address the SCP opinion.
1543  Therefore, there is no reason to believe that 
the Commission was waiting for the applicant to put fo rward a monitoring plan, or, indeed, to provide 
any of the other additional information submitted by the applicant in January 2003.  Consequently, we 
do not consider that the SCP's recommendation just ified the Commission's failure to forward a draft 
measure to the Regulatory Committee before October 2002  
7.2136  We further note that four months after the SCP issued its opinion, in January 2001, the 
applicant sent a letter to the lead CA requesting that the scope of its  application be limited to import 
only and no longer include cultivation.1544  In March 2001, the lead CA informed the Commission that 
it had no objection to the applicant's request.1545  There is no indication that the Commission opposed 
the applicant's request.  While the scope of the appl ication was relevant to the draft measure to be 
submitted by the Commission to the Regulatory Committ ee, the requested change of scope did not, in 
our view, present an obstacle to the Commission launc hing, or continuing, in ter-service consultations 
on a draft measure.  
7.2137  Nor do we see a possible obstacle in the fact th at Directive 90/220 was repealed in October 
2002.  Indeed, the SCP opinion in this procedur e dates from September 2000.  In our assessment, 
there was thus enough time for the Commission to la unch and complete inter-s ervice consultations on 
a draft measure to be submitted to the Regulat ory Committee and for the Commission to adopt its 
draft measure in the event of a favour able vote in the Regulatory Committee.1546  In our assessment, 
the Commission's inaction cannot, therefore, be ex cused on the grounds that the approval procedure 
concerning GA21 maize could not be completed while Directive 90/220 was still in force. 
7.2138  In its earlier findings on the application con cerning GA21 maize, the Panel noted that the 
Commission could have considered that due to the "blocking minority" of the Group of Five countries 
in the Regulatory Committee and the Council, a favourable draft measure would not achieve the 
required qualified majority and that the Commission would then have to complete the procedure by 
adopting its draft measure.  In the Panel's view, even in this scenario, there was enough time for the 
Commission to complete the procedure in question while Directive 90/220 was still in force.  But 
even if it was doubtful that there would be enou gh time in view of anticipated member State 
opposition, the Panel does not consider that this w ould have justified the Commission's failure to 
forward a draft measure to the Regulatory Committ ee.  The Commission would have anticipated a 
"blocking minority" on the basis of the June 1999 declaration by the Group of Five countries.  As 
pointed out above, there is no indication that th e June 1999 declaration was intended to bind the 
Governments of the Group of Five countries vis-à-vis  other member States or the Commission.  In 
other words, the Group of Five countries retained the freedom under EC law to vote in favour of applications in the Regulatory Committee and Council.  In the light of this, we think the Commission 
could not have legitimately invo ked the June 1999 declaration as a justification for not submitting a 
draft measure to the Regulatory Committee prior to October 2002. 
7.2139  Based on the above considerations, the Panel is of the view that, in the specific circumstances 
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure 
                                                     
 
1543 Exhibit EC-78+85/At.  94. 
1544 Exhibit EC-78+85/At.  91. 
1545 Exhibit EC-78+85/At.  92. 
1546 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory 
Committee voted on the application less than three months after the SCP issued its opinion.  Exhibit 
EC-76/At. 72.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 795 
  
  to the Regulatory Committee – no draft measure was forwarded between September 2000 and 
October 2002 – was unjustifiably long.   
7.2140  Regarding DS291, we recall that the United St ates claims that the approval procedure 
concerning GA21 maize (EC-78) was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent 
with the application of such a moratorium.  In the li ght of this, and in the absence of effective rebuttal 
by the European Communities, we ag ree with the United States that it is reasonable to infer that the 
Commission's inaction was a consequence of the general moratorium on approvals.   
7.2141  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United 
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the 
SPS Agreement .  
Conclusions
 
7.2142  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to prepare and forward a draft measure to the Regulatory Committee once the SCP had issued its opinion – no  draft measure was forwarded between 
September 2000 and October 2002 – was unj ustifiably long, and that it can 
reasonably be inferred from surrounding circumstances that  the Commission's 
inaction was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning GA21 maize (EC-78) for final appr oval, and that this resulted in "undue 
delay" in the completion of the relevant a pproval procedure.  Accordingly, the Panel 
concludes that in respect of the approva l procedure concerning GA21 maize (EC-78), 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
  (ii) DS293 (Argentina)  
  With reference to DS293, the Panel reca lls its finding that the time taken by the 
Commission to prepare and forward a draft measure to the Regulatory Committee – no draft measure was forwarded between  September 2000 and October 2002 – was 
unjustifiably long.  In the light of this finding, the Panel concludes that the European Communities failed to complete the a pproval procedure concerning GA21 maize 
(EC-78) without "undue delay", thus breachi ng its obligations under Annex C(1)(a), 
first clause, and Article 8 of the SPS Agreement . 
 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 796 
  
  (xviii)  MON810 x GA21 maize (EC-82) 
7.2143  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning MON810 x GA21 maize has been unduly delayed. 
7.2144  The United States  argues that this application never reached the Community level stage of 
review due to the moratorium.  On 30 November 1999, the lead CA requested that the applicant provide several additional studies to s upport the application for this product.
1547  The applicant 
responded in August 2001 to all requests, exce pt for a scientifically unjustified study on the 
nutritional composition of milk fro m dairy cows fed this product.1548  Given the demonstrated safety 
of maize in feed generally, as well as the substantial data submitted to  support the feed safety of both 
transgenic parents, there is no scientific basis to  suggest a concern.  One of the parental lines 
(MON810 maize) was approved by the European Commun ities several years prior to this application, 
and the feed safety was established as part of that process.1549  In addition, as part of its original 
submission, the applicant had relie d on substantial compositional anal yses of the other parent (GA21 
maize), as well as feeding studies.1550  None of these studies identified anything that would provide 
any basis for the concern raised by the member State. 
7.2145  The United States notes that the lead CA also requested additional studies of the hybrid in 
order to verify the stability of both events jointly.   In the view of the United States, there was no 
logical basis for this request, which implies some  interaction between the MON810 and GA21 events.  
The United States submits that the applicant had already shown the stability of these transformation 
events in each parental line.  The insertions, having  been shown to be stable in the parental lines, 
would be no more likely to be affected by cro ssing than any other gene already present in either 
parent. 
7.2146  The United States notes that the applicant provide d translations in January 2002 of various 
studies it had previously submitted.  Following that, the only activity by the lead CA was a meeting 
held in April 2002.1551  No further action was taken on this application for over 18 months, until the 
applicant volunteered to update the appli cation under Directive 2001/18 on 16 January 2003.1552  The 
applicant, however, subsequently withdrew the application on 15 September 2003, at the same time it 
withdrew the application for GA21 maize (EC-78) , as the delays caused by the moratorium had 
rendered the applications for GA21 maize (E C-78) and MON810 x GA21 maize commercially 
obsolescent.1553   
7.2147  The United States also points out that the application concerning MON810 x GA21 maize is 
one of nine applications identified by the United States which have been pending at the member State 
                                                      
1547 Exhibit EC-82/At. 8. 
1548  Exhibit EC-82/ Ats. 9, 10 and 11.  According to the United States, conducting the dairy cattle 
feeding study would have involved considerable cost and delay to the applicant.  Such a test would require the applicant to obtain approval for further experimental plantings to generate sufficient maize for the feeding study; 
employ external consultants to undertake the required study; grow maize for the feeding study in the 2000 
season; harvest, transport and ensile the maize unde r rigorous experimental conditions; undertake the cow-
feeding phase; analyse the milk samples;  and produce all reports to the Standards of Good Laboratory Practice.     
1549 Commission Decision concerning the placing on the market of genetically modified maize (zea 
mays L. line MON810) pursuant to Council Directive 90/220/EEC, (98/294/EC), April 22, 1998, Official Journal of the European Communities, L 131/32, May 5, 1998 (Exhibit US-131). 
1550 Exhibit EC-82/Ats. 2 and 5. 
1551 Exhibit EC-82/At. 18. 
1552 Exhibit EC-82/At. 20. 
1553 Exhibit EC-82/At. 21.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 797 
  
  level for an average of three years and ten months.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
MON810 x GA21 maize is undue.  The United States subm its, in addition, that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.2148  The European Communities argues that the delays identifie d by the United States can be 
explained by the fact that the safety of one of the parental lines of this hybrid product, GA 21 maize, 
had not yet been assessed.  The lead CA was aw aiting that assessment.  The European Communities 
maintains that it is obvious that the assessment of a hybrid cannot be concluded as long as the 
assessment of one of its parental lines is still ope n.  Furthermore, according to the European 
Communities, the United States acknowledges that the delays were caused by the applicant when it 
stated in response to a question from the Panel that  "the applicant was unable to devote resources to 
respond to the questions posed by the [lead CA] in a timely fashion".
1554  
7.2149  The European Communities further observes that  after discussions between the lead CA and 
the applicant, the application was withdrawn with a letter of 15 September 2003.  The applicant gave 
three reasons for the withdrawal: first, the prog ress in the procedure of NK603 maize to a more 
advanced stage than the GA21 maize (EC-78) a pplication;  second, the introduction of the new 
regulations concerning commercialisat ion of GM products in the European Communities;  and third, 
the change of the company's commercial priorities. 
7.2150  The United States  denies acknowledging that the delays we re caused by the applicant.  The 
summary table of the US response to question 47 fro m the Panel was not intended to indicate that 
delay was the fault of the applicant.  Rather, the applicant recognized that the application for 
MON810 x GA21 maize would not move forward as l ong as consideration of the application for the 
single trait parent GA21 maize (EC-78) remained  suspended under the moratorium.  The United 
States contends that it was pointless for the applican t to devote resources to pursue the application for 
MON810 x GA21 maize when the approval of GA21 ma ize (EC-78) had been stalled for years under 
the moratorium.  Thus, the delay in the app lication for MON810 x GA 21 maize was a direct 
consequence of the delay in the application for GA21 maize (EC-78) under the moratorium.   
7.2151  The United States points out that because of th e delay in the approval procedure concerning 
GA21 maize (EC-78), that product, as well as MON810 x GA21 maize, have been superseded by a 
second generation Roundup Ready ma ize product (NK603 maize and NK603 × MON810 maize, 
respectively).  The United States main tains that the applicant may not have cited undue delays in its 
withdrawal letter because it had a strong incentive to  maintain cordial relati ons with EC regulators 
and saw no advantage of complaining to EC regulators about the length of the delays.  
7.2152  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level  
7.2153  We recall that the lead CA (Spain) in Nove mber 1999 requested additional information from 
the applicant.  The applicant did not provide  the information requested until August 2001.  A 
translation into Spanish of the documents subm itted in the August 2001 response was provided to the 
Spanish CA in January 2002.  The United States ha s pointed out that the applicant did not comply 
                                                      
1554 The European Communities refers to the United States' response to question 47 of the Panel, table 
in Annex I. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 798 
  
  with the Spanish CA's request that it provide a st udy on the nutritional composition of milk from dairy 
cows which had been fed the product in question. 
7.2154  It was only in April 2002 that the Spanish National Biosafety Committee completed its 
review of the January 2002 Spanish translation of  the applicant's documents.  The National Biosafety 
Commission concluded that it still needed the results of feeding studies on cows, and other 
information.
1555  However, there is no indication in the r ecord that a further re quest for information 
was ever sent to the applicant prior to the re peal of Directive 90/220 in October 2002.   
7.2155  According to the European Commun ities, the failure of the lead CA to forward the application 
concerning MON810 x GA21 maize to the Commission prio r to the date of repeal of Directive 90/220 
is justified by the fact that the lead CA was waiting for the result of the Community level assessment 
of one of the parental lines of this hybrid prod uct, GA21 maize (EC-78).  The European Communities 
maintains that it is obvious that the assessment of a hybrid cannot be concluded as long as the 
assessment of one of its parental lines is still open.   
7.2156  We recall that the Spanish CA in May 1999  had given a favourable assessment to the 
application concerning GA21 maize (EC-78) and forw arded that application to the Commission.  
When the application concerning MON810 x GA21 ma ize was submitted, the application concerning 
GA21 maize (EC-78) was under assessment at Community  level.  Furthermor e, in September 2000 
the SCP also issued a favourable opinion on the application concerning GA21 maize (EC-78).1556  It is 
therefore not clear to us why the Spanish CA would not be in a position to reach a conclusion also 
with regard to the application concerning the hybrid product, i.e., MON810 x GA21 maize.  Indeed, 
the record does not indicate that the Spanish CA ever  indicated to the applicant that it was unable to 
proceed due to the failure of the European Commun ities to approve the GA21 maize (EC-78) parent.   
7.2157  As a general matter, it may be correct to say , as the European Communities does, that "the 
assessment of a hybrid cannot be concluded as long as the assessment of one of its parental lines is 
still open".  However, it would seem that the assessment  of the parental lines could also be made in 
the context of the assessment of the hybrid.  At any rate, the Spanish CA could not "conclude" the 
assessment of the application concerning MON810 x GA21 maize completely on its own.  If other 
member States had concerns with Spain's asse ssment of GA21 maize (EC-78), even though that 
assessment appears to have been confirmed by the SCP, they could have raised an objection on that 
basis to Spain's assessment of MON810 x GA21 ma ize and the assessment of that application would 
then also have been "concluded" at Community level.   
7.2158  For these reasons, it is not apparent to us that the Spanish CA needed to  keep the application 
at the member State level in order to avoid th e possibility of conflicting assessments of GA21 maize, 
and we therefore do not consider that the fact that  one of the parental lines was still pending justified 
Spain in not completing its assessment of the a pplication concerning MON810 x GA21 maize.   
7.2159  We note that after receiving a translation of the additional information requested from the 
applicant, it was incumbent on the Spanish CA either to  seek further clarifications or to complete its 
assessment within the 90-day period provided for in Directive 90/220.  As indicated, the National 
Biosafety Commission did not complete its review of the information until two and a half months 
later.  Moreover, there is no evidence that the Sp anish CA requested additional or missing information 
once the National Biosafety Commission had completed its review of the applicant's documents.  Nor 
                                                      
1555 Exhibit EC-82/At. 18. 
1556 Exhibit EC-78+85/At. 90.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 799 
  
  did the Spanish CA complete its assessment after receiving further advice from the National Biosafety 
Commission in April 2002.   
7.2160  We recognize that, by April 2002, the date of repeal of Directive 90/220 was approaching.  
However, we note that in another approval proced ure, the Spanish CA forwarded questions from the 
National Biosafety Commission as late as mid-June 2002.
1557  Moreover, even if the lead CA had 
taken another two or three mont hs to complete its assessment1558, we think that there was still enough 
time for the other member States to review the lead CA's assessment report within 60 days following 
the circulation of the assessment report and, in the absence of objections, for the lead CA to give its 
consent to the placing on the market of MON810 x GA21 maize.1559 
7.2161  Taking account of the aforementioned elements, we see no justification for the lead CA's 
failure, after receiving further advice from the Na tional Biosafety Commission in April 2002, to 
follow up with the applicant to seek more information or  additional clarifications, or for the lead CA's 
failure to complete its assessment in April 2002 or  soon thereafter.  We therefore are not convinced 
that the lead CA could not have proceeded more promptly than it did.    
7.2162  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning MON810  x GA21 maize – notably the time taken by the 
lead CA between January and Oct ober 2002 – was unjustifiably long. 
7.2163  In addition, we recall that the United States claims that the approva l procedure concerning 
MON810 x GA21 maize was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its 
assessment of the application concerning MO N810 x GA21 maize prior to the repeal of 
Directive 90/220 is consistent with the application of such a moratorium.  In the light of this, and in 
the absence of effective rebuttal by  the European Communities, we ag ree with the United States that it 
is reasonable to infer that Spain's conduct was a c onsequence of the general moratorium on approvals.  
7.2164  In view of our conclusion with regard to th e time taken by Spain for its assessment, we do not 
go on to examine other arguments put forward by  the United States in support of its claim under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
                                                      
1557 Exhibit EC-75/At. 13.  
1558 We note, however, that by April 2002 the 90-day period envisaged in Directive 90/220 for a lead 
CA assessment had already been exceeded.   
1559 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force, 
there was no realistic prospect that the Group of Five countries and the Commission would allow the final 
approval of the application in question.  However, the Pa nel does not consider that this would have justified 
Spain's failure to complete its assessment prior to the date of repeal of Directive 90/220.  Spain might have 
anticipated opposition from the Group of Five countries on the basis of their June 1999 declaration.  As pointed 
out above, notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to approve applications.  The same is true for the Commission, which had not issued a declaration comparable to 
that of the Group of Five countries.    WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 800 
  
  Conclusion
 
7.2165  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the applicatio n concerning MON810 x GA21 maize was 
unjustifiably long, and that it can reasonably be inferred from surrounding circumstances that the l ead CA's conduct was a consequence of the general 
moratorium on approvals.  Based on these findings, the Panel accepts the United 
States' contention that, consistent with the general moratorium, the European Communities failed to consider the app lication concerning MON810 x GA21 maize 
for final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning MON810 x GA21 maize, the European Communities 
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the 
SPS Agreement . 
 
(xix) RR sugar beet (EC-88) 
7.2166  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning RR sugar beet has been unduly delayed.  
7.2167  The United States  claims that the application for RR sugar beet was delayed at the first stage 
of the approval process under 90/220 because the l ead CA (Belgium) declined to forward the 
application to the Commission.  The United States argues that although the applicant provided answers to all of the questions raised by the lead  CA, the lead CA failed to complete its review. 
7.2168  The United States also points out that the appli cation concerning RR sugar beet is one of nine 
applications identified by the United States which ha ve been pending at the member State level for an 
average of three years and ten months.  The United States contends in this respect that although time 
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a 
moratorium on approvals, this de lay in completing the approval procedure concerning RR sugar beet 
is undue.  The United States submits, in addition, th at before the European Communities adopted its 
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less 
than three years.  
7.2169  The European Communities  notes that after discussions between the lead CA and the 
applicant, the application was withdrawn by the companies producing the product on 16 April 2004.  
As the reason for the withdrawal, the applicant point ed to a decision to stop any further development 
of the RR sugar beet derived from event T9100152. 
7.2170  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2171  We recall that the application was considered at  a meeting of the Belgian Biosafety Advisory 
Council held on 26 April 1999.  Th e questions which were generated by this me eting were transmitted 
to the applicant in June 1999 and included qu estions on agricultural practices, molecular  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 801 
  
  characterization, toxicology, allerg enicity, and food/feed equivalence.
1560  The applicant provided 
responses to some of these questions in July 1999.1561  Other questions were answered in December 
1999.1562  
7.2172  In October 1999 the lead CA requested additional information on gene tr ansfer in digestive 
tracts.1563  The applicant provided such information in January 2000.1564  We asked the experts 
advising us whether the information regarding a llergenicity, molecular characterization and gene 
transfer in digestive tracts requested  by the lead CA was necessary to  ensure that conclusions of the 
safety assessment were valid.  Dr. Nutti stated that the information provided by the applicant prior to 
October 1999 on these three topics was adequate to en sure that the conclusions of the assessment 
were valid.1565    
7.2173  In February 2000, the lead CA requested missi ng bibliographical references.  The applicant 
provided the relevant referenc es in February and March 2000.1566  According to the chronology 
provided to us, in April 2000 the applicant met wi th the CA to discuss issues relating to identity 
preservation, Good Agricultural Practices, post-mark et monitoring, traceability, public information, 
line-specific detection methods and primers.  The r ecord of this meeting was not provided to us, 
however.  In July 2000, the applicant at its own initiative provided additional information on the 
characterization of a protein and detection protocols.  The applicant noted that this data did not change 
the conclusions of the safety assessment.1567   
7.2174  In November 2000, the lead CA requested fu rther clarifications regarding molecular 
characterization and allergenicity of "event '77'".1568  We asked the experts if the information 
regarding molecular characterization and allergenicity  of "event '77'" requested by the lead CA was 
necessary to ensure that conclusions of the safet y assessment were valid.  Dr. Nutti emphasized that 
the information "for allergenicity was not necessar y to ensure that the conclusions of the safety 
assessment were valid", as the initial application had satisfactorily established the safety of this 
product in this respect.1569  The applicant apparently did not pr ovide the requested information.   
7.2175  In January 2001 the lead CA "invited" the a pplicant to provide a proposal for labelling and 
traceability as well as a proposal for a monitoring plan  and Good Agricultural Practices in accordance 
with the principles of the Common Position of the Council on the amendment of Directive 90/220.  The lead CA indicated that in the absence of voluntary compliance with these principles, it seemed 
that the Commission and the other member States would oppose the approval of the application even 
if the lead CA forwarded it with a positive assessment.
1570  The applicant apparently did not reply to 
the lead CA's invitation.  In June 2001, the lead CA sent the applicant some comments on its 
application, asking the applicant to make corresponding corrections.1571  After the June 2001 
communication from the lead CA there appear to ha ve been no further exchanges between the lead 
CA and the applicant until the repeal of Directive 90/220 in October 2002.   
                                                      
1560 Exhibit EC-88/Ats. 8 and 9. 
1561 Exhibit EC-88/At. 10. 
1562 Exhibit EC-88/At. 13. 
1563 Exhibit EC-88/At. 12. 
1564 Exhibit EC-88/At. 15. 
1565 Annex H, Dr. Nutti's response to Panel Question 42. 
1566 Exhibit EC-88/Ats. 17-21. 
1567 Exhibit EC-88/At. 22. 
1568 Exhibit EC-88/At. 27. 
1569 Annex H, Dr. Nutti's response to Panel Question 43.   
1570 Exhibit EC-88/At. 29. 
1571 Exhibit EC-88/At. 30. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 802 
  
  7.2176  We begin our examination of the lead CA's assessment of the application under 
Directive 90/220 by recalling that the applicant di d not respond to the lead CA's November 2000 
request for additional information.
1572  It would therefore appear that after November 2000 the lack of 
progress of the application under Directive 90/220 is a ttributable to the applicant.  The focus of our 
examination is therefore on the lead CA's conduct prior to the November 2000 request.   
7.2177  We note in this respect that by the end of March 2000 the applicant had provided all 
additional information requested by the lead CA.  Moreover, there is no indication that the Biosafety 
Advisory Council had been asked for further scientif ic input either before or after March 2000.  
Notwithstanding this, the lead CA did not complete it s assessment in the next several weeks.  Instead, 
more than seven months later, in November 2000, the lead CA requested further clarification on 
molecular characterization and allergenicity issu es previously addressed by the applicant.  As 
indicated previously, notably in the case of the clarifications sought concerning allergenicity, Dr. Nutti questioned the need for the info rmation that was requested.  Even ignoring this, we note that the 
European Communities did not provide an explanati on for why the Belgian CA could not have sought 
these clarifications much earlier, given that the applicant had provided add itional information on these 
issues before the end of 1999.   
7.2178  Furthermore, even assuming arguendo  that the lead CA could not have finished its 
assessment between March 2000, when  the applicant provided all additional information requested by 
the lead CA, and the end of July 2000, when the applicant voluntarily submitted additional 
information, and accepting, again arguendo , that the lead CA required some time to review the July 
2000 information, we recall that the November 2000 request came more than seven months after the 
applicant had provided all information requested by the lead CA.  We are not persuaded that the 
completion of the review of the March and July  2000 information required more than twice the 
maximum 90-day period envisaged in Directive 90/ 220 for the entire assessment by a lead CA.  We 
note in this connection that by November 2000, Be lgium had already far exceeded the 90-day period 
provided for in Directive 90/220.   
7.2179  Moreover, the seven-month dela y after March 2000 could not, in our view, be excused on the 
basis that there was insufficient time to comple te the approval procedure concerning RR sugar beet 
while Directive 90/220 was still in force.  Direc tive 90/220 was not repealed until October 2002.  
There was thus enough time for the other member States to review the lead CA's assessment report 
within 60 days following the circulation of the assessment report and, in the absence of objections, for 
the lead CA to give its consent to th e placing on the market of RR sugar beet.
1573 
7.2180  Taking account of the aforementioned elements, we consider that, even assuming that the lead 
CA's November 2000 request for additional informati on was justified, the lead CA could have sought 
that information earlier than it did.  We also cons ider that the lead CA should have done so, as we 
think that by November 2000 the lead CA should ha ve been able to resolve all other outstanding 
scientific or technical issues.  
                                                      
1572 The lead CA in January 2001 reminded the applicant of its November 2000 request for information.  
Exhibit EC-88/At. 29. 
1573 We note that Belgium could have considered that for as long as Directive 90/220 was still in force, 
there was no realistic prospect that the Group of Five countries and the Commission would allow the final 
approval of the application in question.  However, the Pane l does not consider that this would have justified the 
seven-month delay after March 2000.  Belgium might ha ve anticipated opposition from the Group of Five 
countries on the basis of their June 1999 declaration.  However, as poin ted out above, notwithstanding this 
declaration, the Group of Five countries retained the freedom under EC law to approve applications.  The same is true for the Commission, which had not issued a declaration comparable to that of the Group of Five 
countries.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 803 
  
  7.2181  Based on the above considerations, the Panel concludes that the time taken by the lead CA for 
its assessment of the application concerning RR suga r beet – notably the time taken by the lead CA 
between March and November 2000 – was unjustifiably long. 
7.2182  In addition, we recall that the United States clai ms that the approval procedure concerning RR 
sugar beet was unduly delayed because, due to the moratorium, the European Communities failed to 
consider the application in question for final appr oval.  In this respect, we note our earlier findings 
that (i) a general de facto  moratorium on approvals was in e ffect in the European Communities 
between June 1999 and August 2003 and that (ii) the time taken by Belgium to complete its 
assessment is consistent with the application of such  a moratorium.  In the light of this, and in the 
absence of effective rebuttal by th e European Communities, we agree with the United States that it is 
reasonable to infer that Belgium's conduct was a consequence of the general moratorium on 
approvals.  
7.2183  In view of our conclusion with regard to the time taken by Belgium for its assessment, we do 
not go on to examine other arguments put forward by the United States in support of its claim under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusion
 
7.2184  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning RR sugar beet was unjustifiably long, and that it can reasonably be inferred from surrounding circumstances that the lead CA's conduct was a consequence of th e general moratorium on approvals.  Based 
on these findings, the Panel accepts the United St ates' contention that, consistent with 
the general moratorium, the European Comm unities failed to consider the application 
concerning RR sugar beet for final approval, a nd that this resulted in "undue delay" in 
the completion of the relevant approval pro cedure.  Accordingly, the Panel concludes 
that in respect of the approval procedur e concerning RR sugar beet, the European 
Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement. 
 
(xx) MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape (EC-90) 
7.2185  One Complaining Party, Canada, claims that the completion of the separate approval 
procedures for MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape have been unduly delayed.  
While we are mindful of the fact that Canada is making separate product-specific claims in respect of 
the two approval procedures concerning MS1/RF1 o ilseed rape (EC-89) and MS1/RF2 oilseed rape, 
in view of the very similar facts of these pr ocedures, we examine the two claims together. 
7.2186  Canada  argues that the delays in completing the approval procedures for MS1/RF1 oilseed 
rape (EC-89) and MS1/RF2 oilseed rape are both excessive and unjustified, and hence undue.  The 
EC decisions authorizing the placing on the market of MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape in July 1997 stated that "consent shall be given by th e competent authority of France to WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 804 
  
  the placing on the market" of the products in question
1574, yet in 2003, when the Panel was 
established, the lead CA had still failed to  give its consent for either product.  
7.2187  Canada notes that although the Commission t ook the procedural step of sending a "reasoned 
opinion" to France in relation to the withholding of consent for these products on 7 July 1999, the 
Commission has not pursued legal proceedings ag ainst France for infringement of European law 
before the European Court of Justice.1575  No explanation has been pr ovided by France for its refusal 
to comply with the Commission decisions and Di rective 90/220, nor by the Commission for not 
pursuing legal action against France.  This is despite the November 2000 judgment of the French 
Conseil d'Etat that, without new information concerning the risks associated with MS1/RF1 oilseed 
rape (EC-89) and MS1/RF2 oilseed rape, the French Ministry could not call into question the decision 
taken by the Commission.1576  
7.2188  Canada contends that the length of time it has ta ken, so far, for these applications to move 
through the approval system – more than eight y ears – is, by any reasonable standard, "undue" and 
therefore a violation of Annex C(1)(a), keeping in  mind that the final approval for these products still 
has not been given.   However, the amount of tim e these applications have languished in the approval 
procedure is not the sole reason for Canada's clai m that the delays have been undue.  First and 
foremost, the European Communities has had in place, since October 1998, an unjustified moratorium 
on approvals.  Furthermore, the refusal to approve the applications concerning MS1/RF1 oilseed rape 
(EC-89) and MS1/RF2 oilseed rape are not based on  risk assessments, particularly since both products 
were formally approved by the Commission in 1997.   
7.2189  The European Communities  argues that these products obtained a market authorization by 
virtue of Commission decisions of  6 June 1997.  The European Communities submits that from the 
point of view of EC law, the absence of the fina l consent does not mean that the applicant is not 
entitled to place MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape on the market.  The 
doctrine of "direct effect" in Community law means that the applicant could assert the rights granted 
them through the provisions of EC law.1577   
7.2190  The European Communities confirms that th e Commission initiated infringement proceedings 
against France in 1998, however it decided not to ta ke the case to the Court.  This was because the 
very legislation on the basis of which the approv al had been granted had been identified to be 
insufficient and was being revised.  Furthermore, France had raised the same environmental risk 
concerns regarding these two products as it had for the products for which it subsequently adopted 
safeguard measures ( i.e. the identical product MS1/RF1 oilseed rape which had been approved for 
breeding activities in 1996).  
7.2191  The approvals of MS1/RF1 and MS1/RF2 oilseed  rape for import, processing and cultivation 
in 1996 and 1997 did not provide for any reporting or monitoring of marketing in the European 
                                                      
1574 Article 1(1) of each Decision respec tively.  Exhibits CDA-48 and -49. 
1575 European Commission, GMOs: Commission moves against Luxembourg and France, Commission 
Press Release, IP/99/438, Brussels, 7 July 1999 (Exhibit CDA-52).  See also European, Commission, 
Seventeenth Annual Report on Monitoring the Application of Community Law (1999), COM (2000) 92 final, 
Brussels, 23 June 2000 (Sector on Chemicals and Biotechnology), p. 80 (Exhibit CDA-53) 
1576 European Commission, Eighteenth Annual Report on Monitoring the Application of Community 
Law (2000), COM (2001) 309 final, Brussels, 16 July 2001 (Sector on Chemicals and Biotechnology), p. 67 
(Exhibit CDA-50); see also , European Court of Justice, Association Greenpeace France v. Ministère de 
l'Agriculture et de la Pêche , C-6/99 [2000] ECR I-01651 (Exhibit CDA-51). 
1577 The European Communities refers to European Court of Justice, Leberpfennig , Case 9/70 [1970] 
ECR 825.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 805 
  
  Communities.  Accordingly, the European Comm unities claims it is unable to say whether these 
products have been sold in the European Communiti es.  According to the European Communities, no 
oilseed rape varieties derived from MS1/RF1 or MS 1/RF2 oilseed rape have been registered in 
member States' national catalogues or in the Common Catalogue of varieties of agricultural plant 
species – which is a prerequisite for allowing th eir commercial cultivation – because there has been 
no application from companies to do so.  
7.2192  Canada  rejects the EC argument that the absence of  the final consent does not mean that the 
applicant is not entitled to place MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape on the 
market.  Canada submits that this would require th e applicant to pursue legal proceedings within the 
European Communities in order to bring to an e nd the approval procedures.  According to Canada, 
under these circumstances it is obvious that the Eu ropean Communities has fa iled to complete the 
relevant approval procedures under Directive 90/220.  The applicant has been unable to market its 
products in the European Communities as a result of the failure of France to issue the letters of 
consent and the consequent uncertainty regarding th e legal status of the products.  Therefore, the 
European Communities has failed to "complete" the relevant approval procedures without "undue 
delay" in patent violation of Annex C(1)(a) of the SPS Agreement .  Moreover, Canada argues that by 
failing to complete the approval procedures, the Eu ropean Communities has in stituted and maintained 
effective product-specific marketing bans for MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape.  
7.2193  The Panel  begins its analysis by addressing the de lay allegedly caused by France as the lead 
CA. 
Member State failure to give consent to placing on the market
 
7.2194  The Panel notes that although the two applications  concerning MS1/RF1 oilseed rape (EC-89) 
and MS1/RF2 oilseed rape were formally approved  by the Commission for placing on the market in 
June 1997, the lead CA subsequently failed to take  the final step of the approval procedure provided 
for in Article 13(4) of Directive 90/220, which is to grant written consent to the placing on the market 
of a product.  The relevant Commission decisions, which are addressed to the member States, also 
provide in their Article 1(1) that "consent shall be  given by the competent authority of France to the 
placing on the market" of the oilseed rape products in question.1578    
7.2195  Neither Article 13(4) of Directive 90/220 nor the relevant Commission decisions lay down 
specific time periods within which the lead CA had to  give consent.  However, it is clear to us that 
this does not mean that the lead CA could take any am ount of time to complete the step required of it.  
If it were otherwise, the deadlines stipulated in Di rective 90/220 for the completion of other steps of 
the approval procedure, such as the 90-day member State assessment period set out in Article 12, the 
60-day objection period set out in Article 13 and the three-month action period set out in Article 21, 
could easily be nullified and rendered meaningless.  We  recall that in the case of the two applications 
at issue, the approval for both applications was given by the Commission on 6 June 1997.  As of 
October 2002, when Directive 90/220 was repealed, France had not granted its consent to the placing 
on the market of the products at issue.  Thus, un der Directive 90/220, France did not grant its consent 
for more than five years.1579   
                                                      
1578 Exhibits CDA-48 and -49. 
1579 We note, by way of example, that in the approval procedure concerning the Red-hearted chicory, 
which was also conducted under Directive 90/220, the l ead CA gave its written consent two-and-a-half months 
after the Commission approved the application for breeding activities.  Exhibit EC-77/At. 42.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 806 
  
  7.2196  There is some uncertainty as to  the status of the applications concerning MS1/RF1 oilseed 
rape (EC-89) and MS1/RF2 oilseed rape after the repeal of Directive 90/220.  Article 35 of Directive 2001/18 provides that applications submitted under Directive 90/220 in respect of which the 
approval procedures under Directive 90/220 have not been completed by 17 October 2002 are subject 
to Directive 2001/18.  It further provides that by 17 January 2003 applicants had to complement their applications in accordance with Directive 2001/18.  There is no indication that the applications 
concerning MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape were complemented in 
accordance with Directive 2001/18.     
7.2197  The European Communities appears to argue, however, that the approval procedures 
concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape were completed under 
Directive 90/220.  The European Communities contends  that in accordance with  the jurisprudence of 
the European Court of Justice the absence of the fi nal consent from the lead CA does not mean that 
the applicant is not legally entitle d to place MS1/RF1 oilseed rape (EC-89) and/or MS1/RF2 oilseed 
rape on the market.  According to the European  Communities, the applicant could invoke before 
French courts the obligation imposed by the above-n oted Commission decisions on France to give its 
consent to the placing on the market of the products in question.  Canada did not contest that the 
applicant would have this right under EC law.  In  these circumstances, and in the absence of evidence 
to the contrary, we see no grounds for rejecting the European Communities' contention regarding the 
position under its own law.  
7.2198  Accepting the European Communities' contention m eans that as of the date of establishment 
of this Panel, the above-noted Co mmission decisions were still legally binding, and that as of that date 
the applicant could still invoke the above-noted Co mmission decisions against France, since France 
had not given its written consent by then.  This does not mean, however, that either before or after the 
repeal of Directive 90/220 France itself was no lo nger required to comply with the Commission 
decisions and was not obliged to grant its written consent.  
7.2199  We must not, and hence do not, express a view  on whether the approval procedures conducted 
under Directive 90/220 concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape were 
"completed" as a matter of EC law.
1580  However, we may express a view on whether these approval 
procedures were "completed" within the meaning of Annex C(1)(a), first clause.  We have observed 
earlier that the verb "complete" as it appears in A nnex C(1)(a), first clause, indicates that approval 
procedures are not only to be undertaken, but are also to be finished, or concluded, and that the phrase 
"undertake and complete", which also appears in A nnex C(1)(a), first clause, covers all stages of 
approval procedures and should be taken as meaning th at approval procedures are to be started and 
carried out from beginning to end.1581    
7.2200  We do not consider that the European Comm unities finished, or concluded, the approval 
procedures concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape, or that the 
European Communities carried out these procedures fro m beginning to end.  Indeed, Directive 90/220 
provides for the granting of the lead CA's written c onsent to the placing on the market as an integral 
and last step of the approval procedure.1582  In our view, the fact that the applicant could invoke before 
French courts the obligation imposed by the above-n oted Commission decisions on France to give its 
consent to the placing on the market of the products  in question does not demonstrate that the relevant 
approval procedures have already been "completed " within the meaning of Annex C(1)(a), first 
                                                      
1580 We note that Article 35 of Directive 2001/18 uses the phrase "not [...] completed" in connection 
with procedures commenced under Directive 90/220.  
1581 See supra , para. 7.1494. 
1582 Article 13(4) of Directive 90/220.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 807 
  
  clause.  Rather, it indicates that, notwithstanding France's failure to finish the procedures, the 
Commission decisions may be enforceable vis-à-vis  France.   
7.2201  Having determined that the a pproval procedures concerning MS 1/RF1 oilseed rape (EC-89) 
and MS1/RF2 oilseed rape have not been completed,  we now turn to address whether the time taken 
by France to grant its written con sent is unjustifiably long.  The Eur opean Communities asserts in this 
respect that France's inaction after June 1997 was due to concerns about environmental risks, and that 
these same risks led France in November 1998 to  adopt a safeguard measure on MS1/RF1 oilseed 
rape (EC-161).
1583  In considering the EC assertion, we note that we have been provided very little 
information on the approval procedures concerni ng MS1/RF1 oilseed rape (EC-89) and MS1/RF2 
oilseed rape.  In particular, we have seen no ev idence which points to the alleged environmental 
concerns by France.  To the contrary, the Commission decisions approving the applications concerning MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape make clear that France 
forwarded the application to the Commission with a favourable opinion.   
7.2202  Furthermore, there is no indication that France after June 1997 sought additional information 
from the applicant, or proposed to the applicant voluntarily to accept stricter conditions to meet 
France's alleged environmental concerns.  More over, the Commission decisions approving the two 
products specify that Directive 90/220 provides for additional safeguards if new information on risks 
of the products in question became available.  In the light of this, even if France considered that by 
June 1997 there were justifiable r easons for it to consider that th e products in question constituted a 
risk to the environment, it could have taken a saf eguard measure, as it did for MS1/RF1 oilseed rape 
(EC-161), after  giving its written consent to the placing on the market of the two products in 
question.
1584  The concerns underlying France's safeguard  measure would then have been examined by 
the SCP, and a decision on the validity of France's concerns would then have  had to be taken at 
Community level.   
7.2203  For these reasons, we are not persuaded that there were outstanding environmental issues 
which were specific to the products in question, and which France was trying to have the applicant 
address prior to giving its written consent to the placing on the market of these products.   
7.2204  The European Communities offered no other explan ation for France's prolonged inaction.  We 
recall in this regard that in June 1999 France was one of the Group of Five countries which declared 
that they would take steps to suspend further approvals under Directive 90/220 pending the adoption 
of new EC rules on labelling and traceability.  We found earlier that at least as from June 1999 
France's conduct is consistent with  the June 1999 declaration by the Group of Five countries.  Indeed, 
despite a clear legal obligation to give written consent to the placing on the market of MS1/RF1 
oilseed rape (EC-89) and MS1/RF2 oilseed rape, Fran ce withheld its consent and thus prevented these 
products from being approved.  As we have explained earlier1585, however, we consider that the 
perceived need for new EC rules on labelli ng and traceability does not provide a sufficient 
justification for not completing the approval pr ocedures for the products in question and for 
preventing their final approval.   
                                                      
1583 The application concerning MS1/RF1 oilseed rape (EC-161) had been submitted to the United 
Kingdom and was approved for breeding activities in 1996.   
1584 There is nothing in Directive 90/220 which says that a lead CA forwarding an application with a 
positive opinion and giving written consent to the placing on the market of a product may not subsequently take a safeguard measure in respect of that product.  
1585 See supra , paras. 7.1511-7.1518. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 808 
  
  7.2205  Based on the above considerations, the Panel c oncludes that the time taken by France up to 
August 2003, including the time take n after June 1999, for the purpose of giving its written consent to 
the placing on the market of MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape following the 
approval of both applications by the Commi ssion in June 1997 is unjustifiably long. 
7.2206  In view of this conclusion, we do not go on to examine other arguments put forward by 
Canada in support of its claim under Annex C( 1)(a), first clause, and Article 8 of the SPS Agreement .   
Conclusions
 
7.2207  In the light of the above, the Panel reaches the following conclusions:  
 (i) DS292 (Canada) – MS1/RF1 oilseed rape (EC-89) 
   With reference to DS292, the Panel recalls  its findings that the time taken by France 
to give its written consent for the placing on the market of MS1/RF1 oilseed rape 
(EC-89) following its approval by the Commission in June 1997 – no consent was 
given between June 1997 and August 2003 – was unjustifia bly long.  Based on these 
findings, the Panel accepts Canada's conten tion that the European Communities failed 
to "consider or approve, without undue de lay" the application concerning MS1/RF1 
oilseed rape (EC-89), and that it consequent ly did not complete the relevant approval 
procedure without "undue delay".  Accordingl y, the Panel concludes that in respect of 
the approval procedure concerning MS1/RF1 oilseed rape (EC-89), the European 
Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement . 
  (ii) DS292 (Canada) – MS1/RF2 oilseed rape (EC-90)  
  With reference to DS292, the Panel recalls  its findings that the time taken by France 
to give final consent for the placing on the market of MS1/RF2 oilseed rape following its approval by the Commission in June 1997 – no consent was given between June 
1997 and August 2003 – was unjus tifiably long.  Based on these findings, the Panel 
accepts Canada's contention that the Europ ean Communities failed to "consider or 
approve, without undue delay" the applica tion concerning MS1/RF2 oilseed rape, and 
that it consequently did not complete the relevant approval procedure without "undue 
delay".  Accordingly, the Panel concludes that in respect of the approval procedure 
concerning MS1/RF2 oilseed rape, the Eu ropean Communities has breached its 
obligations under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement . 
 
(c) Novel Foods – Applications s ubmitted under Regulation 258/97  
 7.2208  We now turn to examine the approva l procedures which were conducted under 
Regulation 258/97 for the applications identified by the Complaining Parties.  Before embarking on 
an examination of individual approval procedures,  however, we should briefly address certain issues 
presented by the application of Annex C(1)(a), fi rst clause, to approval procedures conducted under 
Regulation 258/97.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 809 
  
  (i) Application of Annex C(1)(a), first clause,  to approval procedures conducted under 
Regulation 258/97 
7.2209  We have found earlier that the approval procedure set out in Regulation 258/97, to the extent 
it is applied to check and ensure the fulfilment of the requirement that novel foods not present a 
danger for the consumer, constitutes an "approval pro cedure" within the meaning of Annex A(1) of 
the SPS Agreement .  On the other hand, we found that to th e extent the same approval procedure is 
applied to check and ensure the fulfilment of the requirements that novel foods not mislead the 
consumer and that they not be nutritionally disadvant ageous for the consumer, that procedure is not an 
"approval procedure" within the meaning of Annex A(1) of the SPS Agreement .   
7.2210  Under Regulation 258/97, once an application for the approval of a novel food product is 
submitted, the fulfilment of the aforementioned three requirements is to  be checked through one 
single approval procedure.  Regulation 258/97 also envisages that if an application does not meet one 
of three requirements, the relevant food product may not be placed on the market.  We recall that the 
Complaining Parties did not challenge Regulati on 258/97 as such, and thus did not question the 
European Communities' decision to conduct one si ngle approval procedure to check all three 
requirements and to grant approvals only in cases where applications comply with all three 
requirements. 
7.2211  It follows from the design of Regulation 258/97  that in the event there is a delay in the 
processing of an application due to the need to ch eck the fulfilment of the requirement that novel 
foods not mislead the consumer, or that they not be nutritionally disadvantag eous for the consumer, 
that delay would also affect the SPS approval procedure conducted for the same application, i.e., the 
procedure applied to check and ensure the fulfilmen t of the requirement that novel foods not present a 
danger for the consumer.  In other words, the SPS a pproval procedure would be delayed if, and to the 
extent that, there was a delay in the non-SPS approval procedure.     
7.2212  We have previously stated that, in our view, Annex C(1)(a), first clause, requires that SPS 
approval procedures be undertaken a nd completed with no unjustifiable lo ss of time.  In the context of 
Regulation 258/97, the issue thus arises whether a de lay caused by the need to check the fulfilment of, 
e.g., the non-SPS requirement that novel foods not be nutritionally disadvantageous for the consumer 
should be considered to constitute, ipso facto , unjustifiable loss of time.   
7.2213  In addressing this issue, we recall that the Complaining Parties did not challenge or question 
the fact that Regulation 258/97 provides that fo r each application a single procedure is to be 
conducted, leading to a single approval.  We consid er that, in these circumstances, a delay in the SPS 
approval procedure should not be viewed as "undue" merely because it arose from the need to check 
the fulfilment of one of the two non-SPS re quirements contained in Regulation 258/97, e.g., the 
requirement that novel foods not be nutritionally disa dvantageous for the consum er.  Indeed, if it were 
otherwise, a situation might arise where the European Communities would have to complete the 
procedure with a substantive decision on the applic ation concerned even if it had not yet been able 
adequately to determine whether the application meets the requirement that the novel food product not 
be nutritionally disadvantageous for the consumer.  The European Communities might thus have to 
approve a novel food product the consumption of wh ich is nutritionally disadvantageous for the 
consumer, and this even though the Complaining Par ties never questioned the fact that in accordance 
with Regulation 258/97 the requirement that a prod uct not be nutritionally disadvantageous must be 
fulfilled before a product is approved.   
7.2214  While we thus do not consider that, in the speci fic circumstances of this case, a delay in the 
SPS approval procedure should be treated as "undue " merely because it arose from the need to check WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 810 
  
  the fulfilment of one of the two non-SPS requirement s contained in Regulation 258/97, it is our view 
that for instance if the time taken to check th e fulfilment of one of those non-SPS requirements 
exceeded the time that is required to do so, the r esulting delay in the SPS approval procedure would 
be at least partly "undue".   
7.2215  In view of the above considerations, we think that for the purposes of our examination of the 
relevant approval procedures in the light of Annex C(1)(a), first clause, we need not, and hence do 
not, make specific findings on whether any delays in a relevant approval procedure arose from the 
need to check the fulfilment of the SPS requireme nt that novel foods not present a danger for the 
consumer or whether they arose from the need to  check the fulfilment of the non-SPS requirements 
that novel foods not mislead the c onsumer and that they not be nu tritionally disadvantageous for the 
consumer.  In the circumstances of this case, either type of delays would be relevant to an inquiry 
under Annex C(1)(a), first clause. 
7.2216  As an additional, but separate, matter, we  should recall that the Regulation 258/97 
applications covering foods or food ingredients wh ich contain or consist of GMOs are subject to 
Article 9 of Regulation 258/97 which provides that  the Commission decision approving the placing on 
the market under Regulation 258/97 must "respect the environmental safety requirements laid down by [Directive 90/220] to ensure that all appropriate  measures are taken to prevent the adverse effects 
on human health and the environment which might arise from the deliberate release of [GMOs]".  As we have said earlier, it would seem to follow from Ar ticle 9 that if the applicant did not submit an 
environmental risk assessment, a Regulation 258/ 97 application could not be approved by the 
Commission unless a Directive 90/220 application concerning the same biotech product had previously been approved.  We observe in this cont ext that it would in our view be contrary to the 
requirements of Annex C(1)(a), first clause, fo r the European Communiti es to proceed with a 
Regulation 258/97 procedure at a delayed pace merely  because of delays which have occurred, or are 
anticipated to occur, in a para llel Directive 90/220 (or Directive 2001/18) procedure concerning the 
same biotech product, provided that further pr ogress in the Regulation 258/97 procedure is still 
possible.  In other words, we consider that the European Communities must proceed as far as possible 
with a Regulation 258/97 proce dure as promptly as possible, unless the applicant requests that the 
Regulation 258/97 procedure proceed more slowly, or that it not proceed faster or further, than a 
parallel Directive 90/220 (or Directive 2001/18) pr ocedure.  In the case of the Regulation 258/97 
applications at issue in this dispute, we are not  aware of the existence of such a request by an 
applicant or of a situation where no further progr ess in the relevant Regula tion 258/97 procedure was 
possible.  
7.2217  Finally, we recall that in Section VII.D we have addressed whether the reason for the general 
EC moratorium on final approvals could have provided a justificati on for delays which might have 
occurred as a result of that moratorium.  These earlier observations are relevant and applicable also to 
our examination of the Regulation 258/97 approval pr ocedures identified by the Complaining Parties.  
7.2218  With these general observations in mind, we now proceed with the examination of the 
individual product-specific measures complained against. 
(ii) GA21 maize (food) (EC-91) 
7.2219  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning GA21 ma ize (food) has been unduly delayed. 
7.2220  The United States  argues that the application concerning GA21 maize (food) under 
Regulation 257/98 was delayed first at the member St ate level in that the lead CA (the Netherlands)  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 811 
  
  took at least 10 months more than required to co mplete its initial assessment.  Subsequently, the SCF 
failed to consider the application for 11 months , and later delayed issuing its assessment for 11 
months without explanation.  Finally, following the positive assessment of the SCF, the Commission 
failed to submit a draft decision to the Regulatory Committee for approval of this product prior to the 
establishment of the Panel.  The United States cons iders these delays to be unwarranted and thus 
undue. 
7.2221  The United States observes that this product was under consideration by the lead CA between 
the submission of the application in July 1998 an d the lead CA's opinion in January 2000.  In 
February 1999, the lead CA requested the appli cant to perform a further study on compositional 
analysis, and the applicant provided its response in October 1999.  Therefore, of the total 18 months 
during which this product was considered at the member State level, only 8 were used by the 
applicant to answer questions.   
7.2222  The United States points out that the applica tion was forwarded to the Commission on 21 
January 2000.  The official member State cons ultation period was over by April 2000.  The United 
States notes that the Commission asked the SCF for an opinion on 18 May 2000.  However, it was eleven months later that the SCF contacted the applicant for the first time, asking for additional 
information.
1586  Within less than one month, the appl icant provided answers to all questions.1587  It 
took a further 11 months for the SCF to issue an opinion on 27 February 2002.1588  Hence the 
application was delayed for 17 months at the Co mmunity level before the SCF rendered its positive 
opinion on 27 February 2002.  In its opinion, the SCF concluded that the da ta submitted, including the 
two whole food studies, were "sufficient for evaluation"1589 and cited these studies in support of its 
ultimate conclusion that "from the point of view of consumer health, maize grain from maize line 
GA21 and derived products [ …] are as safe as grain and derived products from conventional maize 
lines."1590   
7.2223  According to the United States, almost two m onths passed after the positive SCF opinion with 
no activity on this application.  On 23 April 2002,  the applicant offered to reduce the scope of the 
application to include only processed grain and de rived ingredients, but not unprocessed grains, in 
order to enable the authorization procedur e under Regulation 258/97 to proceed immediately.1591  The 
applicant explained that the reason for this proposal  was because the food use of unprocessed grains is 
also subject to Directive 90/220 and that "progress under this Directive has been suspended for some 
time, with the result that GA21 maize grain has not yet been considered for consent."1592   
7.2224  The United States argues that despite the effort s of the applicant to remove any possible 
impediments, the Commission still failed to forw ard the application to the Regulatory Committee 
after the positive SCF opinion.  Instead, as reflected in the minutes of a meeting on 5 June 2002 
between the Commission and the applicant, the Commi ssion noted that although the next step was to 
take a Community Decision, "[i]t is desirable that such a Decision would take into account in an appropriate manner the legislative developments w ith respect to the authorization of GM food and 
                                                     
 
1586 Exhibit EC-91/At. 39.  
1587 Exhibit EC-91/At. 40. 
1588 The current revised regulatory framework recognizes that a period of six months is an achievable 
timeframe for the EC's Scientific Authority (EFSA GMO Panel) to come to an opinion.  Regulation (EC) No. 1829/2003, Article 6.1. 
1589 Exhibit EC-91/At. 43, pp. 11-12. 
1590 Exhibit EC-91/At. 43. 
1591 Exhibit EC-91/At. 44. 
1592 Exhibit EC-91/At. 44. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 812 
  
  feed as well as the labelling of GM products".
1593  The United States maintains that the European 
Communities simply halted the processing of this application in anticipation of possible upcoming changes to its regulations, an action entirely cons istent with the moratorium which the European 
Communities and member State officials had anno unced.  Although both the new food and feed and 
traceability and labelling legislations would not enter into force until 2004, and although the applicant 
stated its preference to apply the labelling require ments currently in effect under Regulation 258/97, 
the Commission noted that "it is clear that it woul d be more difficult to obtain a favourable opinion by 
a majority of Member States in the Comitology pr ocedure" if the applicant were not required to 
anticipate the new labelling requirements be fore the new legislation was adopted.
1594  In other words, 
the applicant was required to wait until the require ments for labelling under pending legislation were 
finalized.  Thus the Commission failed to forward a draft measure to the Regulatory Committee as is 
required to complete the approval process, resulting in  further delay that lasted until the new Food and 
Feed regulation was passed in September 2003. 
7.2225  The United States submits, in addition, that the application concerning GA21 maize (food) is 
one of five applications identified by the Un ited States which are pending at Commission level and 
which, as of the date of establishment of the Pane l, have been pending for an average of four years 
and six months.  The United States contends in this  respect that although time alone is not dispositive, 
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals, 
this delay in completing the approval procedure concerning GA21 maize (food) is undue.  The United 
States submits, in addition, that before the European Communities adopted its moratorium, all 
approval procedures under Directive 90/ 220 were undertaken and completed in less than three years.   
7.2226  Argentina  argues that consideration of the a pplication for GA-21 maize (food) under 
Regulation 258/97 dragged on for a total of 5 years and 2 months without a definitive response.  
Argentina further contends that the chronologies provided by the European Communities verify the 
numerous opportunities in which information additional to what is necessary for appropriate control, 
inspection and approval procedures was required from the applicant.  Argentina contends that since 27 
February 2002, the date on which the SCF expressed its favourable opinion, there has been no further 
progress in the approval process.  Argentina indi cates that the application was withdrawn in 
September 2003 because no progress had been made since 27 February 2002.   
7.2227  The European Communities  argues that the 18 months spent at member State level were due 
to the incompleteness of the dossi er initially submitted and to the need for additional scientific 
data.1595 The dossier was circulated at the Community level in January 2000, as required by the 
regulation.  Many member States requested additiona l information and raised questions, several raised 
objections mainly on grounds of insufficient data  on molecular characterisation and on compositional 
analysis (substantial equivalence).  In May 2000, the Commission requested the opinion of the SCF.  
The SCF found that the dossier did not contain sufficient information concerning substantial 
equivalence and toxicity testing, and had to requ est the relevant information from the applicant.1596  
The SCF finally issued its opinion February 2002.    
7.2228  The European Communities notes the difference between risk assessment and risk 
management and argues that the former is the task of the scientific committees, while the latter is the 
function of the Regulatory Committee.  Since the Regulatory Committee fulfils risk management 
functions, it has to take into account all re levant factors, including risk assessment stricto sensu .  The 
                                                      
1593 Exhibit EC-91/At. 45, p. 1. 
1594 Exhibit EC-91/At. 45 , p. 2. 
1595 Exhibit EC-91/At. 1-6. 
1596 See Request of 24 April 2001 (Exhibit EC-91/At. 17).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 813 
  
  European Communities argues that the draft me asures forwarded by the Commission to the 
Regulatory Committee are therefore supported by scientific assessments, but also address other 
legitimate issues, including risk management i ssues, which are not addressed by a scientific 
committee.   
7.2229  In relation to Regulation 258/97, the European Communities contends that in terms of risk 
management it became clear in 1999 that there woul d have to be new legislation addressing issues 
such as labelling and traceability, and also the deve lopment and validation of detection methods.  In 
relation to the application concerning GA21 maiz e (food), the European Communities submits that 
the SCF's opinion did not address sufficiently all rele vant elements.  The elements which determined 
the insufficiency of the SCF's opinion related to th e issues of validation of  detection methods, which 
were requirements to be include d in the new legislation on "Food and Feed" and on whose importance 
the applicant agreed.  More partic ularly, the European Communities not es that in view of the pending 
legislative proposal for "Food and Feed", in June  2002 the applicant committed on a voluntary basis 
to providing detection and validation methods for its  product in collaboration with the Joint Research 
Centre of the Commission (hereafter the "JRC").   
7.2230  The European Communities notes that agreement on  the amount of data and material and the 
circumstances of their submission to the JRC took a considerable amount of time.  All the necessary 
data were received in proper condition in mid-September 2003.  Th e pre-validation study was initiated 
in October and was concluded after the applicant de livered the full data set at the end of November 
2003.  Some additional testing on the method and ma terials was carried out in early 2004.  The 
collaborative study of method validation was launched in April 2004 and was expected to be finished 
by the end of June 2004.  
7.2231  The Panel  begins its analysis by addressing the Comm ission's failure up to August 2003 to 
submit a draft measure to the Regulatory Committee. 
Failure by the Commission to submit a draft measure to the Regulatory Committee
 
7.2232  We recall that the SCF issued a positive evaluati on of this application in February 2002.  
Following the issuance of the SCF opinion, the Commission did not submit a draft measure to the Regulatory Committee at any point up to August 2003.   The United States a nd Argentina argue that 
the Commission should have prepared and submitt ed a draft measure to the Regulatory Committee 
shortly after the issuance of the SCF opinion. 
7.2233  The record shows that some two months after the issuance in February 2002 of the favourable 
opinion by the SCF Instead, on 23 April 2002, the applicant informed the Commission that it was no longer seeking to obtain approval to place on the ma rket unprocessed GA21 maize grain for food use.  
The applicant explained that this food use would be subject to Directive 90/220
1597, and noted that the 
progress of the application concerning GA21 maize (EC-78) under Directive 90/220 had been 
suspended for some time.  The applicant was hoping that this move would enable the application 
under Regulation 258/97 to proceed immediately.1598   
                                                      
1597 Pursuant to Article 9 of Regulation 258/97, in the case of foods or food ingredients containing or 
consisting of GMOs, the approval decision to be taken mu st "respect the environmental safety requirements laid 
down by Directive 90/220 to ensure that all appropri ate measures are taken to prevent the adverse effects on 
human health and the environment which mi ght arise from the deliberate release of [GMOs]". 
1598 Exhibit EC-91/At. 44. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 814 
  
  7.2234  The record further shows that more than a month later, on 5 June 2002, the Commission 
services met with the applicant.  According to  a Commission report about the meeting, the 
Commission indicated at the meeting that "it wo uld be desirable that a [draft measure on the 
application] would take into account in an appr opriate manner the legislative developments with 
respect to the authorization of GM food an d feed as well as the labelling of GM products".
1599  
Specifically, the Commission sought voluntary commitmen ts with regard to the labelling of foods and 
food ingredients derived from GA21 maize as well as with regard to detecti on methods and reference 
materials. 
7.2235  At the June 2002 meeting, the applicant agr eed to provide additional information and 
materials, including a detection method, so as to provide a basis for traceability, as envisaged in the 
new EC rules proposed by the Commission.  The Co mmission's report of the meeting notes in this 
regard that the Commission might present a draft measure to the Regulatory Committee in November 
2002, provided that a validated detection method was av ailable by then.  At the time of establishment 
of the Panel, the question of the validation of the detection method had not yet been resolved, and so 
by August 2003 no draft measure had been forwarded to the Regulatory Committee.   
7.2236  The record of the approval procedure concerning GA21 maize (food) does not contain any 
evidence to show that the Commission in this procedure launched inter- service consultations on a 
draft measure after the issuance in February 2002  of the favourable opinion by the SCF.  This 
contrasts with the record of other approva l procedures which contains such evidence.1600  Therefore, 
we cannot assume that inter-service consultations  were launched on a draft measure on GA21 maize 
(food).   
7.2237  Indeed, it appears that the Commission preferred first to explore whether the applicant would 
be willing to provide certain add itional information, or to make certain additional commitments, on 
the basis of proposals for new EC legislation.  Wh ile we accept that the applicant's response could 
have had an impact on the kind of draft measur e on which the Commission would launch inter-service 
consultations, this circumstance would not explain why the Commission waited for more than three 
months after the issuance of the SCF opinion before approaching the applicant.   
7.2238  Since the Commission was seeking voluntary comm itments, it was possible that the applicant 
would reject the Commission's request in its entir ety.  Had the applicant done so, the Commission 
would have delayed the procedure by more th an three months, as the Commission would have 
launched inter-service consultations only at that point.    
7.2239  The record contains no information which sugg ests that June 2002 was the earliest date on 
which the Commission could have sought the releva nt voluntary commitments.  Indeed, the European 
Communities itself stated in relation to Regulation 258/ 97 that in terms of risk management it became 
clear in 1999 that there would have to be new legislation addressing issues such as labelling and 
traceability, and also the development and validation of detection methods.  In the light of this, we fail 
to see why it would not have been possible for th e Commission to explore the possibility of voluntary 
commitments with the applicant already in March 2002 rather than only in June 2002.  Indeed, the 
Commission had circulated proposals for appropriate EC legislation as early as July 2001.  Had the applicant said no to the Commission's request, this would have disposed of the issue.   
7.2240  In fact, it is clear from the record that the applicant showed little interest in undertaking 
additional commitments with regard to labe lling.  However, the applicant did accept the 
                                                     
 
1599 Exhibit EC-91/At. 45. 
1600 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 60.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 815 
  
  Commission's request to provide reference material and a detection method which was to be validated 
by the Joint Research Centre of the Commission.  It  appears to us from the record that the applicant 
accepted this request on the basis of the Commi ssion proposals for new legislation, since the 
European Parliament was apparently scheduled to  debate the proposals only in July 2002.  This 
supports our view that the Commission could have s ought this particular commitment prior to June 
2002.   
7.2241  The Commission's report of the June 2002 mee ting indicates that the Commission expected 
"no particular problem with respect to the validation.   However, the availability of reference material 
has not been discussed."
1601  It is clear from this statement that the Commission was aware that 
relevant material might or might not have been available, and that it was therefore possible that the applicant would require time to put together releva nt data and material.  Moreover, as this approval 
procedure shows, a material transfer agreement need ed to be reached before any materials would be 
transferred.  Finally, the Commission in its repor t of the June 2002 meeting made clear that it would 
not forward a draft measure to the Regulatory Committee until a detection method had been validated.  
Therefore, had the applicant been made aware of  the Commission's request earlier, the detection 
method could have been validated sooner, and a draf t measure would also have been submitted to the 
Regulatory Committee sooner.    
7.2242  Taking account of the foregoing elements, we c onsider that for the purposes of exploring the 
possibility of the applicant undertaking voluntary commitments, the Commission could, and should, 
have approached the applicant soon after the issuance  of the SCF opinion (or before) rather than more 
than three months later.   
7.2243  Based on the above considerations, the Panel is of the view that, in the specific circumstances 
of this procedure, the time taken by the Commission to prepare and forward a draft measure to the Regulatory Committee – and in particular the time taken by the Commission to explore the possibility 
of the applicant undertaking voluntary commitments – was unjustifiably long.   
7.2244  Regarding DS291, we recall that the United St ates claims that the approval procedure 
concerning GA21 maize (food) was unduly delayed because, due to the moratorium, the European Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure to the Regulatory Committee meeti ng concerning GA21 maize (food) prior to August 
2003 is consistent with the application of such a mo ratorium.  In the light of this, and in the absence 
of effective rebuttal by the European Communitie s, we agree with the United States that it is 
reasonable to infer that the Commission's conduct was a consequence of the general moratorium on 
approvals. 
7.2245  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United 
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the 
SPS Agreement .   
                                                     
 
1601 Exhibit EC-91/At. 45. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 816 
  
  Conclusions
 
7.2246  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to prepare a draft measure to be submitted to the Regulatory Committee 
– and in particular the time taken to explore the possibility of the applicant 
undertaking voluntary commitments – was unjustifiably long, and that it can 
reasonably be inferred from surrounding circumstances that  the Commission's 
conduct was a consequence of the general moratorium on approvals.  Based on these 
findings, the Panel accepts the United States' contention that, consistent with the general moratorium, the European Commun ities failed to consider the application 
concerning GA21 maize (food) for final appr oval, and that this resulted in "undue 
delay" in the completion of the relevant a pproval procedure.  Accordingly, the Panel 
concludes that in respect of the appr oval procedure concerning GA21 maize (food), 
the European Communities has breached its obligations under Annex C(1)(a), first 
clause, and Article 8 of the SPS Agreement . 
  (ii) DS293 (Argentina) 
 
  With reference to DS293, the Panel reca lls its finding that the time taken by the 
Commission to prepare a draft measure to be submitted to the Regulatory Committee 
– and in particular the time taken to explore the possibility of the applicant 
undertaking voluntary commitments – was unjus tifiably long.  In the light of this 
finding, the Panel concludes that the Eur opean Communities failed to complete the 
approval procedure concerning GA21 maiz e (food) without "undue delay", thus 
breaching its obligations under Annex C(1)(a ), first clause, and Article 8 of the 
SPS Agreement . 
 
(iii) Bt-11 sweet maize (food) (EC-92)  
7.2247  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning the Bt-11 sweet maize (food) has been unduly delayed.   
7.2248  The United States  submits that the processing of this application had been delayed at the 
Commission stage of the process, as the Commission had refused to forward a draft measure to the 
Regulatory Committee as is required to complete the approval process, and the request remained 
blocked as of then.    
7.2249  The United States also points out that the app lication concerning Bt-11 sweet maize (food) is 
one of five applications identified by the Un ited States which are pending at Commission level and 
which, as of the date of establishment of the Pane l, have been pending for an average of four years 
and six months.  The United States contends in this  respect that although time alone is not dispositive, 
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals, 
this delay in completing the approval procedure co ncerning Bt-11 sweet maize (food) is undue.  The 
United States submits, in addition, that before th e European Communities adopted its moratorium, all 
approval procedures under Directive 90/220 were underta ken and completed in less than three years.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 817 
  
  7.2250  The European Communities  notes that, after the lead CA sent its initial assessment report to 
the Commission in May 2000, four member States raised objections and several more requested 
additional information, relating mainly to the antibio tic resistance marker used (PAT protein) and to 
the toxicity studies done in relation to this protein as well as to molecular characterization.   
7.2251  The Commission requested the opinion of the SCF in December 2000.  The SCF requested 
further data which the applicant only supplied in Febr uary 2002.  The SCF issued its opinion in April 
2002, stating that on the basis of the information supplied in the application and further material 
supplied by the applicant in response to queries ra ised by member States and in the light of the 
published literature, it was to be c oncluded that Bt-11 sweet maize (f ood) was as safe for human food 
use as its conventional counterparts. 
7.2252  According to the European Communities, in view of the pending legislative proposal on  
"Food and Feed", the applicant, on a voluntary basis, agreed to provide detection and validation methods for its product in collaboration with the JRC.  The amount of data and material and the 
circumstances of their submission to the JRC we re agreed upon in a planning meeting in October 
2002.  The first set of material sent at the be ginning of 2003 was inadequate in terms of necessary 
amounts and the method provided by the applicant perfo rmed very poorly in a pre-validation study.  
The applicant delivered a proper method and all the necessary materials only by July 2003.  The JRC 
finalized the validation method in October 2003.   
7.2253  In November 2003, the Commission submitted a draft measure to the Regulatory Committee. 
At member States' request, however, the Commission di d not ask for a formal vote, given that several 
member States considered that the scientific questions  they had formulated earlier on the basis of their 
conflicting national scientific evaluations were s till open, and others were  still awaiting further 
scientific risk assessments of their national scientific committees. Between October and early December 2003, three new risk assessments were issued  by the member States, all of which conflicted 
with the SCF opinion.   
7.2254  Finally, the Commission asked for the formal vot e on its draft measure.  However, the draft 
measure did not obtain a qualified majority in th e Regulatory Committee, nor subsequently in the 
Council. The draft measure was adopted by the Commission on 19 May 2004. 
7.2255  With regard to the period of time taken by the Commission before requesting the SCF for an 
opinion, the United States maintains that when the application was first evaluated at the Community 
level in 2000, member States objected on the basis not of scientific grounds, but the general 
moratorium.  The United States cites, as an exam ple, that Denmark's Agriculture and Fisheries 
Council recalled "[i]n August 2000, Denmark submitte d an objection to the approval of Bt-11 maize 
in respect of the novel food regulation with refe rence to the declaration approved by Denmark, 
France, Italy, Greece and Luxembourg on the suspension of new GMO licenses (the moratorium 
declaration), which was made at the Council me eting (environment) on 24-25 June 1999.  The 
objection included a reference to the fact that, pending the approval of a regulation that would 
guarantee the labelling and effective tracing of  GMOs and products derived from them, the 
moratorium countries would block any new licens es for the cultivation and marketing of GMOs."
1602  
Also in August 2000, France cited the yet to be im plemented food and feed regulations as a reason for 
withholding support for Bt-11 sweet maize (food), c hoosing to disregard comprehensive scientific 
findings and instead continue the moratorium on biotech reviews.1603   
                                                      
1602 Exhibit EC-92/At. 80. 
1603 Exhibit EC-92/At. 23, p.2. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 818 
  
  7.2256  According to the United States, there is no sci entific basis for the requests from Austria, 
France and Greece for additional long-term animal feeding studies given the results of the compositional analyses, and the fact that feeding studies conducted on Bt-11 field maize had been 
provided along with simulated digestibility studies, and acute toxicity tests.
1604  Greece had 
acknowledged that these latter studies "showed not a single adverse effect in the dosage tested."1605  
Furthermore, Greece did not identify, with any specifi city, any deficiencies in the data provided, nor 
any reason to believe that these proteins would beha ve any differently than any other protein would 
spontaneously develop new or different toxic prop erties or would otherwise interact with other 
components of the food.  Instead, Greece merely noted that "the in vitro  methodology to study 
degradability of Btk and PAT proteins can be improved", but failed to specify how.   
7.2257  The key difference between sweet and field maize being that sweet maize has a higher 
amount of natural sugars, the United States maintains th at there is no reason to believe that this fact 
alone would render the results of the safety assessme nts conducted on the field maize inapplicable to 
this product.  Nonetheless, Austria, Greece a nd the United Kingdom also argued that additional 
compositional and safety data were necessary to est ablish the equivalence between Bt-11 sweet maize 
(food) and Bt-11 field maize.  Austria summarily  rejected the applicant's reliance on the risk 
assessments conducted by the lead CA and the SCP on Bt-11 field maize, on the grounds that this 
evidence "cannot be considered adequate since swee t maize and field maize have different component 
spectrums."1606  Greece required "analyses for all the parameters" (especially for amino acids, fatty 
acids, anti-nutrients and secondary plant substances)  for both the Bt-11 sweet maize (food) and Bt-11 
field maize, without identifying any unique prope rty that would make the Bt-11 sweet maize (food) 
behave differently than all of the data indicated was likely.1607  Even though the United Kingdom 
acknowledged that "it is accepted that the protein [in sw eet maize] is the same as in the field maize", it 
nevertheless objected on the grounds that studies rela ting to the expression of the introduced genes in 
sweet maize were necessary.1608  No further explanation was provided for rejecting the results of the 
safety data conducted on the parent field maize.   
7.2258  The United States observes that th ese concerns were discounted by  the SCF.  Indeed, the SCF 
noted that "the distinction between the results for the sweet maize and field maize is not relevant to 
the assessment as long as the appropriate correspondi ng non-modified maize is used as control".1609  
7.2259  With regard to the period after the positive asse ssment of the SCF in April 2002, the United 
States notes that the European Communities attempts to justify delays in the processing of the Bt-11 
application by claiming that "[b]etween October and early December 2003 [after the SCF positive opinion], three new risks assessment were issued by the Member States, all of which conflicted with the SCF opinion".
1610  These risk assessments we re supposedly provided by Austria, Belgium and 
France.  The United States maintain s that the EC contention is unsupported by the record.  No risk 
assessments were submitted during that time peri od, according to the European Communities' own 
chronology.  None of the documents submitted duri ng that time period contain any purported risk 
assessments conducted by France, Austria, or Belgium.  At the 10 November 2003 meeting of the 
                                                      
1604 The applicant had referenced the whole food feeding studies it had performed on Bt-11 field maize 
in its submission of 28 November 1998.  The European  Communities did not provide the original submission of 
6 April 1998 for processed products of sweet maize. 
1605 Exhibit EC-92/At. 28. 
1606 Exhibit EC-92/At. 25. 
1607 Exhibit EC-92/At. 28. 
1608 Exhibit EC-92/At. 22. 
1609 Exhibit EC-92/At. 53, section 3.10. 
1610 Responses by the European Communities to the questions posed by the Panel on 3 June 2004, 
Response to Question 1.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 819 
  
  Regulatory Committee,
1611 only a comment was provided by France, not a risk assessment.1612  At the 
Regulatory Committee meeting on 8 December 2003, Austria1613, Belgium1614 and France1615 
submitted written declarations to their votes.  But none of these was a risk as sessment.  Rather, when 
the Regulatory Committee failed to obtain a qualified majority, it was because certain member States 
objected due to the proposed new traceability an d labelling regulations (which did not become 
effective until April 2004).1616 
7.2260  The Panel  begins its analysis by addressing the Comm ission's failure up to August 2003 to 
submit a draft measure to the Regulatory Committee. 
Failure by the Commission to submit a draft measure to the Regulatory Committee  
7.2261  We recall that the SCF issued a positive eval uation of this application in April 2002.  
Following the issuance of the SCF opinion, the Commission did not submit a draft measure to the Regulatory Committee at any point up to August 20 03, although subsequently it did submit a draft 
measure to the Regulatory Committee which was on the Committee's agenda in November 2003.  The 
United States argues that the Commission should have  prepared and submitted a draft measure to the 
Regulatory Committee shortly after the issuance of the SCF opinion in April 2002. 
7.2262  More than a month and a half later, on 5 June 2002, the Commission services met with the 
applicant.  The Commission in its report of the meet ing states that "it would be desirable that a [draft 
measure on the application] would take into a ccount in an appropriate manner the legislative 
developments with respect to the authorization of  GM food and feed as well as the labelling of GM 
products".
1617   
7.2263  More specifically, the report of the meeting addresses the issue of " [d]etection methods, 
traceability, reference materials [and] identification".  According to th e report, the applicant "agree[d] 
to provide" the necessary information and ma terials to the JRC in a timely manner.1618  There is 
nothing in the record which indicates that this "a greement" from the applicant was not voluntary.  The 
report notes that a draft measure might be presente d to the Regulatory Committee in November 2002, 
provided that a validated detection method was availabl e by then.  At the time of establishment of the 
                                                      
1611 Exhibit EC-92/At. 67. 
1612 The French comment does not "evaluate the pote ntial for adverse effects on human or animal 
health" posed by the sweet corn's different sugar metabolism from field corn.  The comment is concerned with 
unintended effects, theoretical risks not identified by any of the existing protein toxicity or animal studies 
conducted.  As the Commission stated in its Proposal for a Council Decision of 28 January 2004, "[t]he concerns raised in the opinion of the 'Agence française de sécurité sanitaire des aliments' (AFSSA) of 26 
November 2003 do not bring any new scientific elements in addition to the initial assessment of sweet maize 
Bt-11 carried out by the competent authorities of the Nether lands".  In fact, these conc erns were also expressed 
in two AFSSA opinions of 21 July 2000 and 20 March 2001 and were duly considered by the SCF in its opinion 
of 17 April 2002, which confirmed the findings of the initial assessment that Bt-11 sweet maize is as safe for 
human food use as conventional maize.  Exhibit EC-92/At. 77. 
1613 Exhibit EC-92/At. 71. 
1614 Exhibit EC-92/At. 73. 
1615 Exhibit EC-92/At. 72. 
1616 Exhibit EC-92/Ats. 67 ("Finally, several Member States questioned the oppo rtunity to proceed with 
the authorization of this product in anticipation of the coming into application of Regulation (EC) 1829/2003 
and 1830/2003."),71,74,75 and76. 
1617 Exhibit EC-92/At. 54. 
1618 Ibid. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 820 
  
  Panel, the question of the validation of the detec tion method had not yet been resolved, and so by 
August 2003 no draft measure had been forw arded to the Regulatory Committee.   
7.2264  The record of the approval procedure concerning Bt-11 sweet maize (food) does not contain 
any evidence to show that the Co mmission in this procedure launche d inter-service consultations on a 
draft measure after the issuance in April 2002 of th e favourable opinion by the SCF.  This contrasts 
with the record of other approval pr ocedures which contains such evidence.
1619  Therefore, we cannot 
assume that inter-service consultations were la unched on a draft measure on Bt-11 sweet maize 
(food).   
7.2265  Indeed, it appears that the Commission preferred first to explore whether the applicant would 
be willing to provide certain add itional information, or to make certain additional commitments, on 
the basis of proposals for new EC legislation.  Wh ile we accept that the applicant's response could 
have had an impact on the kind of draft measur e on which the Commission would launch inter-service 
consultations, this circumstance would not explain why the Commission waited for more than a 
month and a half after the issuance of the SCF opinion before approaching the applicant.   
7.2266  Since the Commission was seeking voluntary comm itments, it was possible that the applicant 
would reject the Commission's request in its entir ety.  Had the applicant done so, the Commission 
would have delayed the procedure by more than a month and a half, as the Commission would have 
launched inter-service consultations only at that point.    
7.2267  The record contains no information which sugg ests that June 2002 was the earliest date on 
which the Commission could have sought the releva nt voluntary commitments.  Indeed, the European 
Communities itself stated in relation to Regulation 258/ 97 that in terms of risk management it became 
clear in 1999 that there would have to be new legislation addressing issues such as labelling and 
traceability, and also the development and validation of detection methods.  In the light of this, we fail 
to see why it would not have been possible for th e Commission to explore the possibility of voluntary 
commitments with the applicant earlier than only  in June 2002.  Indeed, the Commission had 
circulated proposals for appropriate EC legislation as early as July 2001.  Had the applicant said no to 
the Commission's request, this would have disposed of the issue.   
7.2268  In fact, the applicant did accept the Commission's request to provide reference material and a 
detection method which was to be validated by th e Joint Research Centre of the Commission.  It 
appears to us from the record that the applicant accepted this request on the basis of the Commission 
proposals for new legislation, since the European Pa rliament was apparently scheduled to debate the 
proposals only in July 2002.  This supports our vi ew that the Commission could have sought this 
particular commitment prior to June 2002.   
7.2269  As we have noted earlier in the context of  the approval procedure concerning GA21 maize 
(food), we have reason to believe that in seeking th e provision by the applicant of a detection method, 
the Commission was aware that relevant reference ma terial might or might not have been available, 
and that it was therefore possible that the applican t would require time to put together relevant data 
and material.  Moreover, as the European Communities itself points out, the amount of data and material and the circumstances of their submission to  the JRC needed to be agreed upon.  Finally, the 
Commission in its report of the June 2002 meeting made clear that it would not forward a draft 
measure to the Regulatory Committee until a detection method had been validated.  Therefore, had the 
applicant been made aware of the Commission's requ est earlier, the detection method could have been 
                                                     
 
1619 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 60.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 821 
  
  validated sooner, and a draft measure would also  have been submitted to the Regulatory Committee 
sooner.    
7.2270  In our view, since the Commission sought the provision of a detection method on a voluntary 
basis, the Commission could even have approached the applicant prior to the issuance of the SCF 
opinion in April 2002.  The applicant would then have  had the opportunity to make sure that reference 
material and other documents and materials relevant to the validation of a detection method were 
available if and when the Commission sought their tr ansmission.  Indeed, we note that in the approval 
procedure concerning NK603 maize (food), work on method validation was undertaken even before 
the Commission had sought a scientific opinion of the EFSA.
1620   
7.2271  Taking account of the foregoing elements, we c onsider that for the purposes of exploring the 
possibility of the applicant undertaking voluntary commitments, the Commission could, and should, 
have approached the applicant either before or s oon after the issuance of the SCF opinion rather than 
more than a month and a half later.    
7.2272  Based on the above considerations, the Panel is of the view that, in the specific circumstances 
of this procedure, the time taken by the Commission to prepare and forward a draft measure to the Regulatory Committee – and in particular the time taken by the Commission to explore the possibility 
of the applicant undertaking voluntary commitments – was unjustifiably long.   
7.2273  In addition, we recall that the United States claims that the approva l procedure concerning 
Bt-11 sweet maize (food) was unduly delayed because, due to the moratorium, the European 
Communities failed to consider the application in ques tion for final approval.  In this respect, we note 
our earlier findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the Commission's failure to submit a 
draft measure to the Regulatory Committee meeting concerning Bt-11 sweet maize (food) prior to 
August 2003 is consistent with the a pplication of such a moratorium.  In the light of this, and in the 
absence of effective rebuttal by th e European Communities, we agree with the United States that it is 
reasonable to infer that the Commission's conduct was a consequence of the general moratorium on 
approvals. 
7.2274  In view of our conclusion with regard to th e Commission's failure to submit a draft measure 
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United 
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the 
SPS Agreement .   
Conclusion
 
7.2275  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States)  
 
  With reference to DS291, the Panel reca lls its findings that the time taken by the 
Commission to prepare a draft measure to be submitted to the Regulatory Committee 
– and in particular the time taken to explore the possibility of the applicant 
undertaking voluntary commitments – was unjustifiably long, and that it can 
reasonably be inferred from surrounding circumstances that  the Commission's 
conduct was a consequence of the general moratorium on approvals.  Based on these 
                                                      
1620 Exhibit EC-96/At. 34, as well as entries concerning 20 February 2003 and 31 March 2003. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 822 
  
  findings, the Panel accepts the United States' contention that, consistent with the 
general moratorium, the European Commun ities failed to consider the application 
concerning Bt-11 sweet maize (food) for final approval, and that this resulted in 
"undue delay" in the completion of the rele vant approval procedure.   Accordingly, the 
Panel concludes that in respect of the approval procedure concerning Bt-11 sweet 
maize (food), the European Communiti es has breached its obligations under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement . 
 (iv) LL soybeans (food) (EC-93) 
7.2276  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning LL soybeans (food) has been unduly delayed. 
7.2277  The United States  submits that the lead CA (Belgium) refused to forward the application for 
LL soybeans (food) for consideration at the Community level.   
7.2278  The United States also points out that the application concerning LL soybeans (food) is one of 
four applications identified by the United States wh ich have been pending at the member State level 
for an average of three and one half years.  The Un ited States contends in this respect that although 
time alone is not dispositive, in the light of the ackno wledgement by EC officials of the existence of a 
moratorium on approvals, this delay in comple ting the approval procedure concerning LL soybeans 
(food) is excessive and unjustified a nd, hence, undue.  The United States submits, in addition, that 
before the European Communities adopted its  moratorium, all approval procedures under 
Directive 90/220 were undertaken and comp leted in less than three years.   
7.2279  Argentina  claims that as of the date of Argentina's first written submission the application 
was delayed at the member State level for 5 years and 8 months without a final decision on its approval.  Argentina asserts that the European Communities neither processed the application nor 
conducted the required risk assessment.  Argentina argu es that there is no scientific justification for 
the delay, as the "initial reports" were not prepared. 
7.2280  The European Communities notes that the application for LL soybean (food) was with the 
Belgian CA only as of February 1999.  The Commissi on gave notice of the Belgian application to all 
other member States in March 1999.  In Apr il 1999, the Belgium Biosafety Council requested 
additional information from the applicant in order to  proceed with the initial assessment.  The request 
touched upon the issues of subs tantial equivalence and presence of transgenic PAT DNA and PAT 
protein.
1621  The applicant did not fully respond to this request for additional information.  Greece 
(June 1999) and Italy (July 1999) also asked for additional information on various points such as 
nutritional and biochemical characteri zation and toxicity of the transg enic plant, but did not receive 
any answer.1622  In April 2004, the lead CA reminded the applicant to respond to the requests for 
additional information so that it would be able to finalize the pending assessment report. 
7.2281  The European Communities submits  that the United States and Argentina choose to ignore the 
fact that the applicant failed to provide the additi onal information that was requested by the lead CA 
in April 1999, and by Greece and Italy in June  and July 1999.  According to the European 
Communities, all three requests for additional in formation remained mostly unanswered.  The 
European Communities also notes that  on 6 July 2004, the applicant withdrew its application.   
                                                      
1621 Exhibit EC-93/At. 11. 
1622 Exhibit EC-93/Ats. 16 and 17.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 823 
  
  7.2282  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2283  We note that contrary to what the European  Communities asserts, the application concerning 
LL soybeans (food) was with the Belgian CA as of ea rly December 1998, and not only as of February 
1999.1623  On 8 December 1998, the Belgian Genera l Food Inspectorate requested the Belgian 
Biosafety Council to prepare a first evaluation repor t within 90 days of referral of the file.   
7.2284  The record indicates that the Biosafety Counc il met on the application on 17 December 1998.  
At that meeting, concerns were raised that while  the application focused on animal nutrition, a number 
of tests concerning possible human consumption impact s were absent.  The applicant apparently gave 
a written undertaking to address these concerns re lating to substantial equivalence following 
instructions from a Belgian expert.1624   
7.2285  Towards the end of April 1999, the Belgian Bi osafety Council responded to a query from the 
Belgian General Food Inspectorate.  The letter not es that the applicant had still not addressed the 
Biosafety Council's concerns relating to substantial equivalence.  The letter further states that the 
applicant needed to provide add itional information regarding the implementation of labelling and, 
more specifically, the presence of PAT DNA and PAT protein in derived soya products.1625  The letter 
of the Biosafety Council concludes by saying that due to the absence of data and information on substantial equivalence and the presence of transg enic PAT DNA and PAT protein it was not possible 
for the Biosafety Council to issue a final evaluation report with regard to the application concerning 
LL soybeans (food).  We asked the experts advising us whether information regarding substantial 
equivalence and the presence of transgenic PAT DNA and PAT protein was necessary to ensure that conclusions of the safety assessment were valid .  Dr. Nutti responded that these requests were 
valid.
1626     
7.2286  In May 1999, the lead CA sent a reminder to the applicant informing it that it had yet to reply 
to the two requests for additional informati on referred to in the letter of April 1999.1627  The lead CA 
also informed the Commission that  the deadline for evaluation of this application would not be met 
due to the lack of response from the applicant to the aforementioned two requests for additional 
information.1628  The record indicates that as of August 2003,  the applicant had still not fully replied to 
the first request relating to substantial equivalence.1629  It appears that the applicant responded to the 
first request concerning the presence of PAT DNA and PA T protein in derived soya products, but it is 
not clear when.1630    
7.2287  Greece (June 1999) and Italy (July 1999) also requested additional information regarding 
nutritional and biochemical characterization and toxicity  of the transgenic plants.  We again asked the 
experts advising us whether the additional informa tion requested by Greece and Italy was necessary to 
ensure that conclusions of the safety assessment were  valid.  Dr. Nutti responded that the application 
did not provide all the information which would be expected in order to comply with the 
recommended Codex evaluation procedure, and theref ore the requests for some of this information 
                                                      
1623 Exhibit EC-93/Ats. 1 and 3.  
1624 Exhibit EC-93/At. 11. 
1625 Ibid. 
1626 Annex H, Dr. Nutti's response to Panel Question 48. 
1627 Exhibit EC-93/At. 14. 
1628 Exhibit EC-93/At. 13. 
1629 Exhibit EC-93/At. 25. 
1630 Ibid. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 824 
  
  were justified.
1631  In December 2000 and again in July 2001, the applicant apparently provided 
additional information to the lead CA regarding in sert characterization, however this information was 
not provided to us.  In the same correspondence,  the applicant indicated that information on 
compositional analyses would be forthcoming at a later date.1632  Seven months later, in 
correspondence dated July 2001, the applicant appa rently provided information to satisfy these 
requests, although this information was not included in the evidence provided to us.1633 
7.2288  In August 2001, the lead CA requested clarifi cation regarding nutritiona l composition, stating 
that the data provided by the applicant in July 2001 had not adequately addressed the lead CA's 
request of April 1999.  We again asked the experts whether this clarification was necessary to ensure 
that conclusions of the safety assessment were valid.  Dr. Nutti noted that the information requested 
would normally be necessary to judge the safety of the product, however given the incompleteness of 
the record, it was impossible for her to determine whet her or not this information had previously been 
provided to the lead CA.1634  The lead CA also inquired about a broiler chicken growth performance 
study which the applicant had said was already includ ed in the dossier, but which the lead CA could 
not find.  Finally, the lead CA indicated that  in accordance with new recommendations by the 
Biosafety Council on molecular characterization, th e lead CA would be requesting some additional 
information on molecular characterization.   
7.2289  The record suggests that the applicant neve r replied to the August 2001 request for 
clarification.  Indeed, in June 2003, in intern al e-mail correspondence concerning a request from the 
Commission for an update on this dossier, the lead CA  highlighted the fact that the applicant had not 
provided the requested broiler chicken growth st udy.  The lead CA also indicated that it had 
requested, but not received, additional informati on on molecular characterization.  However, the 
record does not indicate that such a re quest was forwarded to the applicant.1635 
7.2290  It is unfortunate that the evidence provided on  this application is incomplete.  While the 
experts indicated that much of the information requ ested by the lead CA and by other member States 
was necessary to ensure a valid safety assessment, it  was not possible to determine to what extent 
such information may already have been provided by the applicant.  It is also very difficult to 
determine from the information before us whether pa rticular requests for information were met by the 
applicant.     
7.2291  This said, as noted earlier, it appears that the a pplicant never fully replied to the lead CA's 
April 1999 request for additional information.  As al so noted, the part of the request which remained 
unresolved, notwithstanding the applicant's undertaki ng to provide the relevant information, was 
made known to the applicant already after the De cember 1998 meeting.  It also appears that the 
responses which were given by the applicant in r esponse to the April 1999 request were not provided 
in a timely manner.  Furthermore, the record s uggests that the applicant never responded to the 
August 2001 request for clarification.  In fact, there does not appear to have been any further 
communication from the applicant until it withdrew its application in July 2004.   
7.2292  In the light of the foregoing elements, and in particular the fact that the applicant did not 
provide information it apparently undertook to provid e and otherwise failed to respond to requests for 
information which were not explic itly challenged, we are not pers uaded by the United States' and 
                                                      
1631 Annex H, Dr. Nutti's response to Panel Question 49. 
1632 Exhibit EC-93/At. 21. 
1633 Exhibit EC-93/At. 22. 
1634 Annex H, Dr Nutti's responses to Panel Question 50.   
1635 Exhibit EC-93/At. 25.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 825 
  
  Argentina's assertion that the time taken by Belgium up to August 2003 to assess the application 
concerning LL soybeans was unjustifiably long.  
7.2293  In view of our conclusion with regard to the time taken by Belgium for its assessment, we go 
on to examine other arguments put forward by the United States and Argentina in support of their 
claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement .   
Total amount of time taken since submission of application
 
7.2294  The United States and Argentina also put forward the argument that the total amount of time 
during which the application concerning LL soybeans (food) was pending is excessive and 
unjustified.  The application concerning LL soybeans  (food) was first submitted for approval at the 
end of November 1998.  This means that as of Au gust 2003, the approval procedure had been pending 
for four years and nine months. 
7.2295  We agree with the United States and Argentina that, in absolute terms, this is a long period of 
time for an initial assessment.  Howeve r, as we have explained earlier,  the mere identification of the 
total amount of time during which an application has been pending does not demonstrate, in and of 
itself, that the time taken was unjustifiably long.   
7.2296  The United States argues that that  before there was an EC moratorium, approval procedures 
used to be completed in less than three years.  Ev en if the United States were correct, however, it must 
be remembered that the Europ ean Communities assesses applicati ons on a case-by-case basis.  Thus, 
the fact that the approval procedure concerning LL soybeans (food) was not completed in less than 
three years in our view does not demonstrate that it was not justifiable for the European Communities 
to take more time to process that particular application.   
7.2297  The United States further argues that in the light of the acknowledgement by EC officials of 
the existence of a moratorium on approvals, the fact  that the application in question lingered at the 
member State level for well over four years demonstr ates the existence of undue delay.  We recall in 
this respect our finding that the record suppor ts the conclusion that the European Communities 
applied a de facto  moratorium on approvals as of June 1999.  At that time, the application concerning 
LL soybeans (food) had already been pending for almo st seven months.  Thus, some of the total time 
taken cannot be explained by the mo ratorium.  Moreover, the mere fact  that a general moratorium was 
in effect does not necessarily imply that a particular application was affected by it.  The United States itself has repeatedly stated that "the moratorium wa s a decision by the EC not to move products to a 
final decision in the approval process" and that "c ertain progress in the process, short of a final 
decision, is not the least bit inconsiste nt with a moratorium on final approvals".
1636  Therefore, by 
itself, the fact that a moratorium on approvals w as in effect between June  1999 and August 2003 is 
not sufficient to demonstrate that the period of  time during which the application concerning LL 
soybeans (food) was pending as of August 2003 reflects a failure on the part of the lead CA to 
complete the relevant approval pr ocedure without undue delay.  
7.2298  Accordingly, the Panel is unable to accept the United States' and Argentina's assertion that the 
total period of time during which the application concerning LL soybeans (food) had been pending as of August 2003 demonstrates that th e time taken was unjustifiably long. 
                                                     
 
1636 See, e.g., US second written submission, para. 51 (emphasis in original). WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 826 
  
  Conclusions
 
7.2299  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that it has not been established 
that the time taken by the lead CA for its initial assessment of the application concerning LL soybeans (food) was unjustifiably long, or that the total period of time during which the application concerning LL soybeans (food) had been pending as of 
August 2003 demonstrates that the time  taken by the European Communities was 
unjustifiably long.  Based on these findings , the Panel is unable to accept the United 
States' contention that, consistent with the general moratorium, the European Communities failed to consider the app lication concerning LL soybeans (food) for 
final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning LL soybeans (food), the United States has failed to establish that the European Communiti es has breached its obligations under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement . 
  (ii) DS293 (Argentina) 
 
  With reference to DS293, the Panel recalls its findings that it has not been established 
that the time taken by the lead CA for its initial assessment of the application concerning LL soybeans (food) was unjustifiably long, or that the total period of time during which the application concerning LL soybeans (food) had been pending as of 
August 2003 demonstrates that the time  taken by the European Communities was 
unjustifiably long.  In the light of these findings, the Panel concludes that in respect of the approval procedure concerning LL soybeans (food), Argentina has failed to establish that the European Communiti es has breached its obligations under 
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement . 
 (v) MON810 x GA21 maize (food) (EC-94) 
7.2300  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning MON810 x GA21 maize (food) has been unduly delayed. 
7.2301  The United States argues that approval for MON810 x  GA21 maize (food), which is 
produced by conventionally hybridizing two "par ental" biotech products, MON810 maize and GA21 
maize, has been delayed by the failure of the le ad CA to complete its initial assessment.  More 
specifically, the United States argues that at the time of establishment of the Panel, the application had 
already been under consideration by the lead CA for three and a half years.  The United States 
contends that this lag had two distinct causes. 
7.2302  According to the United States, one cause for the lag was the undue delay in the EC approval 
of GA21 maize under Regulation 258/97.  The a pplication for approval of MON810 x GA21 maize 
(food) submitted under Regulation 258/ 97 referenced the detailed risk  assessments undertaken on the 
parental biotech products, complemented with conf irmatory safety and characterization data on the 
MON810 x GA21 hybrid.  One parent, MON810 maiz e, was approved under Directive 90/220 in  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 827 
  
  1998
1637 and was notified in 1998 on the basis of an opi nion of substantial equivalence as required 
under Regulation 258/97 in 1998.1638  However, the application for the single trait parent GA21 maize 
(food) under Regulation 258/97 stalled at the Co mmission level after the Commission requested an 
opinion from the SCF in May 2000 and then again after the final SCF opinion in February 2002.  
Therefore, progress on GA21 maize (food) was a limiting step on the progress of the application concerning MON810 x GA21 maize (food) in the regulatory process.  In fact, in its comments on the application for MON810 x GA21 maize (food), Italy stated that "examination of the documentation 
relating to authorization [of MON810 x GA21 maize] should only be carried out after the marketing 
of GA21 has been authorized [under Regulation 258/97]."
1639  At the time of establishment of the 
Panel, the approval of GA21 maize (food) under Re gulation 258/97 had not yet been granted. 
7.2303  The United States contends that the other cause of  the lag reflected, in part, the need for the 
applicant to respond to requests for information that were scientifically unjustified.  The United States 
points out that the lead CA insisted on mol ecular characterization of the MON810 x GA21 line 
without regard to the previous data that had been  submitted on the parental lines.  In particular, the 
lead CA requested an additional whole food study in mice.1640  The rationale offered for this request 
was the need to address hypothetical concerns th at unknown pieces of DNA could be scattered over 
the genome.  The impact of any such insertions can be determined by evaluating the compositional 
analyses of the plant as well as its agronomic pe rformance.  If both analyses indicate no unexpected 
changes, the United States argues,  there is no basis on which to hypothesize a food safety concern for 
food from the plant.  In this case,  such assessments had been perfor med on each of the parental lines 
and no unexpected changes were observed.  At no ti me did the lead CA provide any explanation of 
the reason it believed that the compositional analyses or feeding studies previously submitted on both the parent lines, as well as the compositional an alyses submitted on the hybrid, did not adequately 
address this issue.  
7.2304  The United States notes that, nonetheless, the a pplicant analysed the composition of the 
MON810 x GA21 maize, which was found to be compar able to that of the parental lines and other 
commercial maize varieties.
1641  The applicant also had previously submitted several whole food 
feeding studies,  including a 90-day feeding study in rats using MON810 maize or GA21 maize, and a 
broiler chicken feeding study using grain from MON810 x GA21 maize.  None of these studies 
revealed any adverse effects.  
7.2305  Furthermore, the United States notes, the lead CA  requested further information on the levels 
of EPSPS protein expressed in the hybrid lines, although such information is not relevant to assessing 
the risks given the known safety information about the EPSPS protein.1642  The lead CA also 
requested unnecessary comparisons of compositional da ta between the new hybrid and non-transgenic 
control lines.  The data submitted in the applica tion analysed the new hybrid in comparison to the 
                                                      
1637 Commission Decision concerning the placing on the market of genetically modified maize (zea 
mays L. line MON810) pursuant to Council Directive 90/220/EEC, (98/294/EC), April 22, 1998, Official 
Journal of the European Communities, L 131/32, May 5, 1998 (Exhibit US-131).  
1638 Exhibit US-132.   
1639 Exhibit EC-94/At. 11. 
1640 Exhibit EC-94/At. 12. 
1641 Exhibit EC-82/At. 9. 
1642 The United States refers to LA Harrison, MR Bailey, MR Naylor, JE Ream, BG Hammond, DL 
Nida, BL Burnette, TE Nickson, TA Mitsky, ML Taylor, RL Fuchs, and SR Padgette, "The Expressed Protein in 
Glyphosate-Tolerant Soybean, 5-Enolypyruvylshikimate-3-Phosphate Synthase from Agrobacterium sp.  Strain CP4, Is Rapidly Digested in Vitro and Is Not Toxic to Acutely Gavaged Mice", Journal of Nutrition  126:728-
740 (1996) (Exhibit US-143).  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 828 
  
  transgenic parental lines.
1643  The transgenic parental lines had al ready been shown to be substantially 
equivalent to non-genetically modified maize except for the introduced traits.  Given all of the data 
that had been submitted on both parental lines, the United States argues that the requests for yet 
further studies lacked any scientific basis.   
7.2306  According to the United States, the United Kingdom  also insisted that the applicant provide 
extensive characterization of the new hybrid, rather th an rely on the analyses previously carried out on 
the transgenic parental lines.1644  As part of this request, the United Kingdom requested molecular 
characterization to "confirm[] the absence of  antib iotic resistance markers a nd have details regarding 
the homology between the two constructs introduced as a result of the crosses."1645  Given that neither 
parent contained an antibiotic marker gene, there is absolutely no scientific basi s, in the United States' 
view, for theorizing that cross-breeding between the two products would somehow introduce such a 
gene. 
7.2307  Under these circumstances, the United States argue s that it was pointless for the applicant to 
devote resources to pursue the application for M ON810 x GA21 maize (food) as long as consideration 
of the applications for the single trait parent GA 21 maize remained suspended under the moratorium.  
The United States contends that the delay in the application for MON810 x GA21 maize (food) and GA21 maize (food) is thus a direct consequence of  the delays in the application for GA21 maize 
under the moratorium.  The United States further point s out that because of the delay in the approval 
procedure concerning GA21 maize (food), that pr oduct, as well as MON810 x GA21 maize, have 
been superseded by a second generation Roundup Ready maize product (NK603 maize and 
NK603 × MON810 maize, respectively).  Nonetheless, the applicant has continued to pursue the 
necessary regulatory clearance for MON810 x GA21 maize (food). 
7.2308  The United States submits, in addition, that the application concerning MON810 x  GA21 
maize (food) is one of four applications identifie d by the United States which have been pending at 
the member State level for an average of three and one  half years.  The United States contends in this 
respect that although time alone is not dispositive, in  the light of the acknowledgement by EC officials 
of the existence of a moratorium on approvals, this delay in completing the approval procedure 
concerning MON810 x  GA21 maize (food) is undue.  The United States further argues that before the 
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were 
undertaken and completed in less than three years.    
7.2309  The European Communities  argues that the lead CA requested additional information from 
the applicant in July 2000, and that that request was only partly answered in February 2002.  Contrary 
to the United States, the European Communities main tains that the lead CA request for a whole food 
study in mice was necessary to assess unintende d effects caused by possible additional DNA 
fragments.  The request was made on valid grounds.   Therefore, the delay caused by it cannot be 
considered "undue."  The European Communities adds  that issues such as mo lecular characterization 
of inserted DNA from transgenic parent lines, th e determination of fla nking DNA or compositional 
analysis, still remain unaddressed.  Furthermore, the European Communities considers that it is 
obvious that the assessment of a hybrid cannot be concluded as long as the assessment of one of its 
parental lines is still open.  
7.2310  The Panel  commences its analysis with the alleged delay at member State level. 
                                                     
 
1643 Exhibit EC-94/At. 2. 
1644 Exhibit EC-94/At. 10. 
1645 Ibid.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 829 
  
  Delay at member State level 
 
7.2311  We recall that although the application was su bmitted on 29 February 2000, the record shows 
that the first contact by the lead CA to request additional information from the applicant occurred only 
on 17 July 20001646, i.e., more than four and a half months after receipt of the application.    The 
response to the July 2000 request for information was provided by the applicant only on 15 February 
2002.  Subsequently, there was a further, five-mont h delay before the lead CA followed up with the 
applicant to request additional information on 2 July  2002.  Finally, we note that no information has 
been provided regarding any action on this app lication between July 2002 and August 2003.  It 
appears that during that period the applicant did not  respond to the lead CA's July 2002 request for 
information.  
7.2312  The United States contends that the lengthy dela y caused by the applicant due to the time it 
took to respond to the July 2000 request for info rmation occurred, in part, because there was no 
justification for requesting the relevant data.  In  our earlier findings, we observed that the experts 
expressed the view that whereas some of the inform ation requested by the lead CA was not necessary 
to ensure the validity of the safety assessment, othe r requested information was indeed needed.  We 
also previously noted the disagreement of the Euro pean Communities with the views expressed by the 
experts regarding the need for the data requested. 
7.2313  Even accepting that contrary to the views of the experts the information requested by the lead 
CA in July 2000 was necessary to en sure the validity of the safety assessment, this could not provide a 
justification for the time taken by the lead CA fo r its assessment of the application both before and 
after the July 2000 request for information.   
7.2314  In examining the issue of the time taken by th e lead CA before and after the July 2000 
request, we first recall that Regulation 258/97 provi des that the lead CA should complete its initial 
assessment within three months of receipt of an ap plication which contains the necessary information.  
We recognize that the question of whether or not the lead CA complied with the three-month deadline 
stipulated in Regulation 258/97 is not dispositive, per se , of whether the European Communities met 
its WTO obligation to complete its approval procedures without undue dela y.  This said, in the Panel's 
view, the deadline set forth in Regulation 258/97 provides a useful indicator to guide the Panel's analysis.  The three-month deadline is binding and a pplies to all relevant a pplications submitted under 
Regulation 258/97.  It may therefore be assumed that  the EC legislator set this binding deadline in 
such a way as to make it possible for the CAs of all member States to assess even complex 
applications within the prescribed deadline.    
7.2315  We first turn to consider the time taken by th e lead CA before forwarding its initial request 
for information of July 2000.  We note that when the Commission circulated notice of this application 
to all member States, it indicated that the initial assess ment was to be completed by the lead CA by 16 
June 2000 at the latest.
1647  However, by 16 June 2000, the l ead CA not only had not completed its 
initial assessment, but it apparently had not even iden tified any need for further information.  It was 
not until one full month after the deadline circulated  by the Commission that the lead CA forwarded 
an initial request for information.   
7.2316  The European Communities asserts that all of th e time taken by the lead CA was necessary to 
resolve scientific and technical issues, but provides no specific justification for the time taken by the 
lead CA up to July 2000.  Even if it were accepted that in this procedure the lead CA could not have 
                                                      
1646 Exhibit EC-94/At. 12. 
1647 Exhibit EC-94/At. 5. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 830 
  
  met the mid-June deadline circulated by the Commissi on, this would not imply that the lead CA could 
not have requested missing information much sooner, rather than a full month after the date on which 
it should have completed its entire initial assessment.   
7.2317  We note that three member States submitted subs tantive comments or requests for further data 
prior to July 2000.
1648  However, Regulation 258/97 does not require the lead CA to await comments 
from other member States, let alone possible r esponses thereto from the applicant, prior to 
undertaking its initial assessment.  
7.2318  We have previously pointed out that the Nether lands was part of the Group of Seven countries 
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing 
with applications for the placing on the market of bi otech products.  However, in this instance, we are 
not convinced that the Dutch CA's conduct reflects a precautionary approach.  Indeed, we are not 
convinced that the Dutch CA could not have id entified any need for additional information and 
forward an appropriate request for information to the applicant sooner than it did even while 
following a precautionary approach.   
7.2319  We now turn to the time taken by the lead CA after it had received the applicant's response to 
its initial request for information of July 2000.  As we indicated above, four and a half months lapsed 
between the receipt of the information requested in  July 2000 and the next request, in July 2002, for 
additional information.  Thus, the lead CA took more  time to assess the additi onal information than it 
should have used, in accordance with Regulation 258/ 97, to complete its entire initial assessment.   
7.2320  As with the time taken by the lead CA up to th e first request for information, the European 
Communities asserts that the time taken by the l ead CA up to the second request for information was 
necessary to resolve scientific and technical issues.  However, the European Communities provides no 
specific justification for why the lead CA required mo re than four and a half months to complete its 
consideration of the responses provided and to identify short-comings.  It is pertinent to note in this 
respect that the information provided by the app licant in response to the July 2000 request was 34 
pages long.  Given this, and in the absence of a specific justification offered by the European 
Communities, we are not convinced that the lead CA  could not have evaluated much sooner than it 
did whether additional information was still needed.  We also consider that the Dutch CA could have 
forwarded its July 2002 request for additional informa tion to the applicant at a much earlier date even 
while following a precautionary approach.    
7.2321  In relation to the time taken by the lead CA both before and after the July 2000 request for 
information, we note, as an additional matter,  the European Communities argument that the 
assessment of a hybrid product such as MON810 x GA21 maize cannot be concluded as long as the 
assessment of one of its parental lines is still open.   Thus, the European Co mmunities appears to argue 
that the time taken by the lead CA to assess the application concerning MON810 x GA21 maize 
(food) is justified by the fact that the lead CA  was waiting for the result of the Community level 
assessment of one of the parental lines of this hybrid product, GA21 maize (food).   
7.2322  It is correct that between February 2000 and July 2002, the application concerning GA21 
maize (food) was still being evaluated at Community level.  However, the record does not indicate 
that the Dutch CA ever stated that it was unabl e to proceed due to the failure of the European 
Communities to approve the GA21 maize (food) parent .  Moreover, we recall that it was the same 
Dutch CA which assessed the application concerning  GA21 maize (food) and which in late January 
2000 forwarded it to the Commission with a favourab le assessment.  Therefore, we see no reason why 
                                                      
1648 Exhibit EC-94/Ats. 9-11.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 831 
  
  the Dutch CA would not be in a position to reach a conclusion also with regard to the application 
concerning the hybrid product, i.e., MON810 x GA21 maize.  
7.2323  As a general matter, it may be correct to say , as the European Communities does, that "the 
assessment of a hybrid cannot be concluded as long as the assessment of one of its parental lines is 
still open".  However, it would seem that the assessment  of the parental lines could also be made in 
the context of the assessment of the hybrid.  At any rate, the Dutch CA c ould not have "concluded" 
the assessment of the application concerning MON810 x GA21 maize (food) completely on its own.  
If other member States had concerns with the Dutch assessment of the application concerning GA21 
maize (food) (even though that assessment was confir med by the SCP in early 2002), they could have 
raised an objection on that basis to the Dutch assessment of the application concerning MON810 x 
GA21 maize (food) and the assessment of that app lication would then have been "concluded" at 
Community level.   
7.2324  For these reasons, it is not apparent to us that the Dutch CA needed to keep, or would have 
been justified in keeping, the application at the me mber State level in order to avoid the possibility of 
conflicting assessments of MON810 x GA21 maize (food), and we therefore do not consider that the 
fact that one of the parental lines was still pending  justified the Netherlands in not completing its 
assessment of the application concerning MON810 x GA21 maize (food).   
7.2325  Taking account of all of the aforementioned elem ents, we consider that upon receipt of the 
original application and subsequent ly upon on receipt of the information requested by it in July 2000, 
the lead CA could, and should, have determined  more promptly that additional information was 
needed and could, and should, have forwarded appr opriate requests to the applicant more promptly.  
7.2326  Based on the above considerations, we therefore conclude that the time taken by the lead CA 
for its assessment of the application concer ning MON810 x GA21 maize (food) was unjustifiably 
long. 
7.2327  In addition, we recall that the United States claims that the approva l procedure concerning 
MON810 x GA21 maize (food) was unduly delayed becau se, due to the moratorium, the Netherlands 
failed to consider the application in question for fi nal approval.  In this respect, we note our earlier 
findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and A ugust 2003 and that (ii) the tim e taken by the Netherlands for 
its initial assessment of MON810 x GA21 maize (food) is  consistent with the application of such a 
moratorium.  In the light of this, and in th e absence of effective rebuttal by the European 
Communities, we agree with the United States that it is reasonable to infer that the Netherlands' 
conduct was a consequence of the ge neral moratorium on approvals.  
7.2328  In view of our conclusion with regard to th e time taken by the Netherlands for its initial 
assessment, we do not go on to examine other argumen ts put forward by the United States in support 
of its claim under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement .   
Conclusion
 
7.2329  In the light of the above, we reach the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the applicatio n concerning MON810 x GA21 maize was WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 832 
  
  unjustifiably long, and that it can reasonably be inferred from surrounding 
circumstances that the l ead CA's conduct was a consequence of the general 
moratorium on approvals.  Based on these findings, the Panel accepts the United 
States' contention that, consistent with the general moratorium, the European 
Communities failed to consider the app lication concerning MON810 x GA21 maize 
(food) for final approval, and that this resu lted in "undue delay" in the completion of 
the relevant approval procedure.  Accordingl y, the Panel concludes that in respect of 
the approval procedure concerning MON810 x GA21 maize (food), the European 
Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement . 
 
(vi) Bt-1507 maize (food) (EC-95) 
7.2330  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning Bt-1507 maize (food) has been unduly delayed. 
7.2331  The United States  argues that the lead CA (Netherlands ) refused to forward this application 
to the Commission, thereby unduly delaying its consideration for approval.   
7.2332  The United States also points out that the application concerning Bt-1507 maize (food) is one 
of four applications identified by the United Stat es which have been pending at the member State 
level for an average of three and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
Bt-1507 maize (food) is undue.  The United States subm its, in addition, that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years.   
7.2333  The European Communities  observes that after receiving the application in February 2001, 
the lead CA asked for additional information in June  2001.  This information was finally provided in 
February 2003.  Between February 2003 and Ju ly 2003, there was ongoing correspondence between 
the applicant and the lead CA on additional informati on to be submitted by the applicant, in particular 
on labelling, monitoring, molecular characterization,  and event-specific detection methods.  The lead 
CA finalized the initial assessment report in Novemb er 2003 and concluded th at the consumption of 
Bt-1507 maize as well as foods and food ingredient s derived from it were as safe for humans as the 
consumption of the non-genetically modified counterparts. 
7.2334  The European Communities further notes th at the Commission forwarded the initial 
assessment report to member States for comment s in December 2003, and received comments and 
reasoned objections against the initial assessmen t.  On 26 March 2004, the complete dossier 
(including responses to the objections and comments raised by member States) was forwarded to 
EFSA for consideration under Regulation 1829/2003.  In  parallel, the applicant undertook the steps to 
ensure the production of certified reference material  and for the validation of a detection method by 
the JRC. 
7.2335  The Panel  notes that the United States' claim is based on an alleged delay at member State 
level.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 833 
  
  Delay at member State level
 
7.2336  We recall that the application concerning Bt-1507 maize (food) was submitted on 15 February 
2001.  However, the first request for additional information from the lead CA was made only on 
28 June 2001, i.e., almost four and a half months followi ng receipt of the application.  Although the 
applicant apparently provided a partial response in  November 2001, it appears that it did not provide 
all of the information requested until 12 February 2003.  Following the twenty-month period taken by 
the applicant to provide all the in formation requested, in March 2003, the lead CA requested further 
clarifications, which were provide d in May 2003.  In June 2003, the lead CA posed questions in 
relation to the applicant's May 2003 reply.  The ap plicant provided answers by 9 July 2003.  The 
information as provided by 9 July 2003 was apparently deemed sufficient by the lead CA to conclude 
its assessment.  As noted, a positive assessment was reported on 4 November 2003.   
7.2337  It is clear from the foregoing that the major delay in the assessment of this application is 
attributable to the time taken by the applicant to pr ovide the information requested in June 2001.  We 
asked the experts advising us for their views on the necessity of the information requested by the lead 
CA in June 2001 to ensure that the conclusions of the safety assessment were valid.  We recall that the 
experts considered that some of the information requested by the lead CA in June 2001 was not 
necessary to ensure the validity of the safety assessment for Bt-1507 maize (food).  This included 
some of the information which was not provided by the applicant until February 2003.   
7.2338  Even if we were to accept that all of the inform ation requested by the lead CA in June 2001 
was necessary to ensure the validity of the safety assessment, this could not provide a justification for 
the time taken by the lead CA for its assessment of the application before the June 2001 request for 
information.  We recall that the application con cerning Bt-1507 maize (food) had been under review 
in the Netherlands for more than four and a half months before the Dutch CA forwarded its June 2001 
request for information.   
7.2339  In examining the issue of the time taken by the lead CA before the June 2001 request, we first 
recall that Regulation 258/97 provides that the lead CA should complete its initial assessment within 
three months of receipt of an application which contains the necessary information.  We recognize 
that the question of whether or not the lead CA co mplied with the three-month deadline stipulated in 
Regulation 258/97 is not dispositive, per se , of whether the European Communities met its WTO 
obligation to complete its approval procedures without undue delay.  This said, in the Panel's view, 
the deadline set forth in Regulation 258/97 provides a useful indicator to guide the Panel's analysis.  
The three-month deadline is binding and appli es to all relevant app lications submitted under 
Regulation 258/97.  It may therefore be assumed that  the EC legislator set this binding deadline in 
such a way as to make it possible for the CAs of all member States to assess even complex 
applications within the prescribed deadline.    
7.2340  We note that by the time the lead CA forwarded its first request for information at the end of 
June 2001, the lead CA had already exceeded the three-month period envisaged in Regulation 258/97 
by a month and a half, yet it was far from completing its initial assessment.  The European Communities asserts that all of the time taken by th e lead CA was necessary to  resolve scientific and 
technical issues, but provides no specific justification for the time taken by the lead CA up to the end 
of June 2001.  Even if it were accepted that in th is procedure the lead CA could not have completed 
its initial assessment within the th ree-month period provided for in Regulation 258/97, this would not 
imply that the lead CA could not have requested missing information much sooner.  Given the three-month maximum assessment period envisaged in  Regulation 258/97, and lacking a specific 
justification by the European Communities, we are not convinced that the lead CA could not have 
evaluated much more promptly than it did whethe r additional information was still needed.     WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 834 
  
  7.2341  We have previously pointed out that the Nether lands was part of the Group of Seven countries 
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing 
with applications for the placing on the market of bi otech products.  However, in this instance, we are 
not convinced that the Dutch CA's conduct reflects a precautionary approach.  Indeed, we are not 
convinced that the Dutch CA could not have id entified any need for additional information and 
forwarded an appropriate request for information to the applicant sooner than it did even while 
following a precautionary approach.   
7.2342  Taking account of all of the aforementioned elem ents, we consider that upon receipt of the 
original application, the lead CA could, and shou ld, have determined more promptly that additional 
information was needed and could, and should, have forwarded an appr opriate request to the applicant 
more promptly.  
7.2343  Based on the above considerations, we thus conc lude that the time taken by the lead CA for 
its assessment of the application concerning Bt-1507 maize (food) – and in particular the time taken 
by the lead CA before forwarding its first request  for additional information – was unjustifiably long. 
7.2344  In addition, we recall that the United States claims that the approva l procedure concerning 
Bt-1507 maize (food) was unduly delayed because, due to the moratorium, the Netherlands failed to 
consider the application in question for final appr oval.  In this respect, we note our earlier findings 
that (i) a general de facto  moratorium on approvals was in e ffect in the European Communities 
between June 1999 and August 2003 and that (ii) the failure of th e Netherlands to complete the initial 
assessment of the application concerning Bt-1507 ma ize (food) by August 2003 is  consistent with the 
application of such a moratorium.  In the light of this, and in the absence of effective rebuttal by the 
European Communities, we agree with the United St ates that it is reasonable to infer that the 
Netherlands failure to complete its initial asse ssment by August 2003 was a consequence of the 
general moratorium on approvals. 
7.2345  In view of our conclusion with regard to th e time taken by the Netherlands for its initial 
assessment, we do not go on to examine other argumen ts put forward by the United States in support 
of its claim under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement .   
Conclusion
 
7.2346  In the light of the above, we reach the following overall conclusion:  
 (i) DS291 (United States) 
 
  With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning Bt-1507 maize (food) – particularly the time taken prior to the lead CA's initial request for additional information – was unjustifiably long, and that it can reasonably be inferred from 
surrounding circumstances that the lead CA's conduct was a consequence of the 
general moratorium on approvals.  Base d on these findings, the Panel accepts the 
United States' contention that, consistent w ith the general moratorium, the European 
Communities failed to consider the appli cation concerning Bt-1507 maize (food) for 
final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning Bt-1507 maiz e (food), the European Communities has 
breached its obligations under Annex C(1)(a ), first clause, and Article 8 of the 
SPS Agreement .  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 835 
  
   
(vii) NK603 maize (food) (EC-96) 
7.2347  Two Complaining Parties, the United States and Argentina, claim that the completion of the 
approval procedure concerning NK603 maiz e (food) has been unduly delayed.  
7.2348  The United States  argues that although the application concerning NK603 maize (food) 
eventually received a positive assess ment from the lead CA  (Netherlands), this product was at the 
member State level for almost 19 months, instead of the 90 days foreseen by Regulation 258/97.  Of this period of time, only three and a half months were used by the applicant to provide additional 
information;  the lead CA used the remaining fourteen and a half months.  
7.2349  The United States questions certain requests fo r additional information from the lead CA, 
arguing they were scientifically unnecessary.  For example, the lead CA requested an additional 
whole food feeding study in mice or rats, to a ddress concerns about the presence of unintended DNA 
fragments that the applicant had identified as pa rt of their molecular characterization data.
1649  The  
lead CA stated that "the presence of additional unintended modifications cannot be excluded with 
sufficient certainty".  The United St ates argues that the mere fact th at an additional insert is present 
does not necessarily mean that the product presents an  additional risk.  Rather, the determination turns 
on the results of all of the other data and informa tion provided by the applicant, which the lead CA 
failed to take into consideration in making this request.  If the results of those tests raise questions, 
then further examination would be warranted.  But in this case, the applicant had conducted 
compositional analysis and a broiler chicken w hole food study with the product containing the 
additional insert, and in these circumstances would ha ve detected any resulting changes relevant to 
food safety.  The United States observes that the ap plicant nevertheless conducted the requested test, 
which identified no adverse effects. 
7.2350  The United States further argues that once the application had reached the Community level 
Austria filed an objection in respect of the application for NK603 maize (food) on the grounds that not 
only acute but also sub-chronic, mutagenic, repr oductive and ecotoxic effects of the protein (EPSPS) 
should be studied.  However, Austria failed to discuss the results of the acute studies, or to provide an 
explanation of why the proteins in this product would behave differently than all available data 
indicate is likely.  The United States submits that given that EPSPS proteins are commonly found in a wide variety of food sources which have a long history of safe use, the available information 
regarding the enzyme function of the protein, lack of homology to toxic proteins based on 
bioinformatics searches, and lack of acute oral toxi city when administered to mice at high doses, the 
additional toxicological testing for the EPSPS prot ein that Austria demanded is unfounded and 
unreasonable.  Such testing exceeds Codex Alimentarius guidelines,
1650 as well as the European 
Communities' own Scientific Committee Guidance Docu ment for the Risk Asse ssment of Genetically 
Modified Plants and Derived Food and Feed (March 2003). 
7.2351  The United States submits, in addition, that th e application concerning NK603 maize (food) is 
one of five applications identified by the Un ited States which are pending at Commission level and 
which, as of the date of establishment of the Pane l, have been pending for an average of four years 
and six months.  The United States contends in this  respect that although time alone is not dispositive, 
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals, 
this delay in completing the approval procedur e concerning NK603 maize (food) is undue.  The 
                                                      
1649 Exhibit EC-96/At. 7.  
1650 The United States refers to Codex Alimentarius, "Guideline for the Conduct of Food Safety 
Assessment of Foods Derived from Recombinant-DNA Plants", CAC/GL 45-2003, paras. 37, 38. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 836 
  
  United States submits, in addition, that before th e European Communities adopted its moratorium, all 
approval procedures under Directive 90/ 220 were undertaken and completed in less than three years.   
7.2352  Argentina  argues that NK603 maize (food) was stalled at various stages of the approval 
process under Regulation 258/97.  Argentina notes that the assessments performed by the lead CA and 
subsequently the EFSA concluded th at there was no evidence of risk to human health or life.  
Therefore, it is clear that the delays by the lead CA to complete its initial assessment and forward this 
application to the Commission were not justified.  
7.2353  The European Communities  notes that the application for food use of the NK603 maize was 
submitted to the Netherlands in 2001.  After the a pplicant submitted additional information requested 
by the lead CA, the lead CA completed its evaluation in November 2002 and sent its initial 
assessment report to the Commission.  The eighteen m onths spent at member State level were due to 
the incompleteness of the dossier initially submitted by  the applicant and the need for further data on 
molecular characterization and compositional analysis. 
7.2354  The European Community further notes that th e Commission circulated the dossier to all 
member States in January 2003.  Three member Stat es raised objections and several others requested 
additional information.  The European Comm unities points out in this connection that 
Regulation 258/97, in general term s, provided an adequate framework for a risk assessment for GM 
food products.  However, in terms of risk management, it became cl ear in 1999 that there would have 
to be new legislation addressing some issues su ch as labelling and traceability, and also the 
development and validation of de tection methods.  The application concerning NK603 maize (food) 
was partially affected by this situation as it had reached the Community level and the stage of risk 
management considerations.  Thus, it was considered  necessary to require the validation of a detection 
method as a pre-condition for marketing approval.   This was done on the basis of a voluntary 
agreement with the applicant.  These detection methods were validated for NK603 maize (food) and 
the decision-making process was launched immediately after.  
7.2355  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level
 
7.2356  We recall that the applicant first submitted the a pplication to the lead CA in April 2001.  Two 
months later the lead CA requested copies of cited literature and data in order to facilitate the lead 
CA's work.  The applicant provided these documents in July 2001.  However, the first request for 
additional information from the lead CA was made onl y in December 2001, more than four and a half 
months later.  In August 2002, five  months after the applicant supplied the information requested by 
the lead CA, the lead CA's advisory body, th e Dutch Health Council's Committee on the Safety 
Assessment of Novel Foods, finished its assess ment report.  It was not until November 2002, 
however, that the lead CA forwarded its assessment report to the Commission.   
7.2357  It is clear from the foregoing that the December 2001 request for information led to delay in 
the consideration of this application inasmuch as the applicant took more than three months and a half 
to respond to the request.  We asked the experts advising us for their views on the necessity of the 
information requested by the lead CA in December 2001 to ensure that the conclusions of the safety 
assessment were valid.  We recall the view expressed by one of the experts that the request in question 
was not necessary to ensure the va lidity of the safety assessment.   
7.2358  However, even accepting that the information requested by the lead CA in December 2001 
was appropriate to ensure the validity of the safet y assessment, this could not provide a justification  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 837 
  
  for the time taken by the lead CA to assess the ap plication.  Notably, the application concerning 
NK603 maize (food) had been under review in the Neth erlands for more than se ven months before the 
Dutch CA forwarded its December 2001 request for information.
1651  Moreover, once the applicant 
had provided information in response to the Dutc h CA's December 2001 request for information, the 
Health Council's Committee on the Safety Assessment  of Novel Foods still took more than four 
months to complete its initial assessment report.  Wh ile this report needed to be adopted by the Dutch 
CA, the report was not forwarded to the Commissi on for another two and a half months.     
7.2359  In examining the issue of the time taken by th e lead CA for its assessment of the application 
concerning NK603 maize (food), we first recall that Regulation 258/97 provides that the lead CA 
should complete its initial assessment within three months of receipt of an application which contains 
the necessary information.  We recognize that the question of whether or not the lead CA complied 
with the three-month deadline stipulated in Regulation 258/97 is not dispositive, per se , of whether 
the European Communities met its WTO obligation to complete its approval procedures without 
undue delay.  This said, in the Panel's view, the deadline set forth in Regulation 258/97 provides a 
useful indicator to guide the Panel's analysis.  Th e three-month deadline is binding and applies to all 
relevant applications s ubmitted under Regulation 258/97 .  It may therefore be assumed that the EC 
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member 
States to assess even complex applications  within the prescribed deadline.    
7.2360  We first turn to consider the time taken by th e lead CA before forwarding its initial request 
for information of December 2001.  We note that by  the time the lead CA forwarded its first request 
for information, the lead CA had already ex ceeded the three-month period envisaged in 
Regulation 258/97 by more than four months, ye t it was far from completing its initial assessment.1652  
The European Communities asserts that all of the tim e taken by the lead CA was necessary to resolve 
scientific and technical issues, but provides no specifi c justification for the time taken by the lead CA 
up to December 2001.  Even if it were accepted that  in this procedure the lead CA could not have 
completed its initial assessment within the three-month period provided for in Regulation 258/97, this 
would not imply that the lead CA could not have requested missing information much sooner.  Given 
the three-month maximum assessment period envisage d in Regulation 258/97, and lacking a specific 
justification by the European Communities, we are not convinced that the lead CA could not have 
evaluated much more promptly than it did whethe r additional information was still needed.     
7.2361  We have previously pointed out that the Nether lands was part of the Group of Seven countries 
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing 
with applications for the placing on the market of bi otech products.  However, in this instance, we are 
not convinced that the Dutch CA's conduct reflects a precautionary approach.  Indeed, we are not 
convinced that the Dutch CA could not have id entified any need for additional information and 
forwarded an appropriate request for information to the applicant sooner than it did even while 
following a precautionary approach.   
7.2362  Taking account of the aforementioned elements, we consider that upon receipt of the original 
application, the lead CA could, and should, ha ve determined more promptly that additional 
information was needed and could, and should, have forwarded an appr opriate request to the applicant 
more promptly.  
                                                      
1651 The application had been under re view for more than four months after receipt of copies of the 
cited literature and data.  These copies were not requeste d by the lead CA until two months after receipt of the 
application.   
1652 Even if it were considered that a complete app lication was only available as of the end of July 
2001, the lead CA would still have exceeded the three- month period by more than four and a half months. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 838 
  
  7.2363  We now turn to consider the time taken by the lead CA to complete and forward its 
assessment report.  To recall, five months after th e applicant supplied the information requested by the 
lead CA in December 2001, the lead CA's scientific advisory body in August 2002 finished its 
assessment report.  However, the lead CA did no t forward its assessment report to the Commission 
until November 2002, i.e., for more than two and a half months.    
7.2364  While accepting that the advisory  body's assessment report needed to be adopted by the Dutch 
CA, we recall that in accordance with Regulation 2 58/96 the Dutch CA was required to complete its 
entire initial assessment within no more than three months.  Given this, and lacking a specific 
justification by the European Communities, we are not convinced that the Dutch CA could not have 
adopted the report in question much sooner than it  did in the case of the application concerning 
NK603 maize (food).   
7.2365  Thus, based on the above considera tions, we conclude that the time taken by the lead CA for 
its assessment of the application concerning NK603 ma ize (food) – and in particular the time taken by 
the lead CA before forwarding its first request for additional information as well as the time taken by 
the lead CA to forward its completed as sessment report – was unjustifiably long. 
7.2366  In addition, we recall that the United States claims that the approva l procedure concerning 
NK603 maize (food) was unduly delayed because, due to  the moratorium, the European Communities 
failed to consider the application in question for fi nal approval.  In this respect, we note our earlier 
findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the time taken by the Netherlands to 
complete its initial assessment of the application concerning NK603 ma ize (food) is consistent with 
the application of such a moratorium.  In the light of this, and in the absence of effective rebuttal by 
the European Communities, we agr ee with the United States that it is reasonable to infer that the 
Netherlands' conduct was a consequence of  the general moratorium on approvals. 
7.2367  In view of our conclusion with regard to th e time taken by the Netherlands for its initial 
assessment, we do not go on to examine other arguments put forward by the United States and Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the 
SPS Agreement .   
Conclusions
 
7.2368  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning NK603 maize (food) – particularly the time taken by the lead CA before forwarding its first request for 
additional information as well as the time taken by the lead CA to forward its 
completed assessment report – was unjustifia bly long, and that it  can reasonably be 
inferred from surrounding circumstances that the lead CA's conduct was a consequence of the general moratorium on approvals.  Based on these findings, the 
Panel accepts the United States' contenti on that, consistent with the general 
moratorium, the European Communities failed to consider the application concerning 
NK603 maize (food) for final approval, and that  this resulted in "undue delay" in the 
completion of the relevant approval procedure.   Accordingly, the Panel concludes that 
in respect of the approval procedure c oncerning NK603 maize (food), the European  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 839 
  
  Communities has breached its obligations under Annex C(1)(a), first clause, and 
Article 8 of the SPS Agreement . 
 
 (ii) DS293 (Argentina) 
   With reference to DS293, the Panel recalls its finding that the time taken by the lead 
CA for its assessment of the application concerning NK603 maize (food) – particularly the time taken by the lead CA before forwarding its first request for 
additional information as well as the time taken by the lead CA to forward its 
completed assessment report – was unjustifiably long.  In the light of this finding, the 
Panel concludes that the European Comm unities failed to complete the approval 
procedure concerning NK603 maize (food) with out "undue delay", thus breaching its 
obligations under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement . 
 
(viii) RR sugar beet (food) (EC-102)   
7.2369  One Complaining Party, the United States, claims that the completion of the approval 
procedure concerning RR sugar beet (food) has been unduly delayed. 
7.2370  The United States  argues that the lead CA (Netherlands) refused to forward the application to 
the Commission and that this resulted in undue delay.   
7.2371  The United States also points out that the app lication concerning RR suga r beet (food) is one 
of four applications identified by the United Stat es which have been pending at the member State 
level for an average of three and one half years.  The United States contends in this respect that 
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the 
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning 
RR sugar beet (food) is undue.  The United States s ubmits, in addition, that before the European 
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were 
undertaken and completed in less than three years. 
7.2372  The European Communities  argues that after discussions between the Dutch CA and the 
applicant, the request was withdrawn on 16 April 2004.   As the reason for its withdrawal the applicant 
pointed to a decision to stop any furthe r development of the RR sugar beet.   
7.2373  The Panel  commences its analysis with the alleged delay at member State level. 
Delay at member State level 
 
7.2374  We recall that the applicant submitted the app lication concerning RR sugar beet (food) to the 
lead CA on 3 November 1999.  However, the first re quest for additional information from the lead CA 
was made only on 24 March 2000, almost five mont hs later.  The applicant responded one month 
later.  In May 2000, the lead CA requested furthe r information.  That information was provided on 7 
December 2000.  On 16 May 2001, after review ing the additional information provided by the 
applicant in December 2000, the lead CA requested fu rther information.  The lead CA indicated that it 
was not yet fully satisfied with the information pr ovided by the applicant concerning the likelihood of 
specific protein formation.  In addition, menti oning recent studies which had shown that "unintended 
effects on GMOs" were possibly caused by transformati on of plant cells, the lead CA also requested a 
semi-chronic oral toxicity study on rats in order to  "to rule out possible undesirable effects [...] with WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 840 
  
  sufficient certainty".
1653  No specific study was cited in this regard.  There is no indication in the 
evidence before us that the applicant responded to the requests from the lead CA for further 
information prior to August 2003.   
7.2375  We sought the advice of the experts assisting us  regarding whether the additional information 
requested by the lead CA in May 2001 was necessar y to ensure that the conclusions of the safety 
assessment were valid.  Dr. Nutti expressed the view th at "the information requested by the lead CA 
regarding the derived proteins and the request for a se mi-chronic oral toxicity te st on mice or rats with 
edible parts of sugar beet was not necessary to en sure that the conclusions of the safety assessment 
were valid".  She emphasized that the applicant had already completed an acute toxicity test on rats 
and conducted studies which confirmed that RR s ugar beet "was equivalent in composition and 
nutrition to the conventional counterpart".1654  
7.2376  Even accepting that contrary to the views of Dr. Nutti the information requested in May 2001 
was necessary to ensure the validity of the safety asses sment, this would not pr ovide a justification for 
the time taken by the lead CA before initially requesting additional information in March 2000 
(almost five months), and the time taken to revi ew the information received in December 2000 (five 
months).   
7.2377  In examining the issue of the time taken by th e lead CA for its assessment of the application 
concerning RR sugar beet (food), we first recall that Regulation 258/97 provides that the lead CA should complete its initial assessment within three months of receipt of an application which contains 
the necessary information.  We recognize that the question of whether or not the lead CA complied 
with the three-month deadline stipulated in Regulation 258/97 is not dispositive, per se , of whether 
the European Communities met its WTO obligation to complete its approval procedures without 
undue delay.  This said, in the Panel's view, the deadline set forth in Regulation 258/97 provides a 
useful indicator to guide the Panel's analysis.  Th e three-month deadline is binding and applies to all 
relevant applications s ubmitted under Regulation 258/97 .  It may therefore be assumed that the EC 
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member 
States to assess even complex applications  within the prescribed deadline.    
7.2378  We first turn to consider the time taken by th e lead CA before forwarding its initial request 
for information of March 2000.  We note that by the time the lead CA forwarded its first request for 
information, the lead CA had already exceed ed the three-month period envisaged in 
Regulation 258/97 by almost two months, yet it w as far from completing its initial assessment.  The 
European Communities asserts that all of the time taken by the lead CA was necessary to resolve 
scientific and technical issues, but provides no specifi c justification for the time taken by the lead CA 
up to March 2000.  Even if it were accepted that in this procedure the lead CA could not have 
completed its initial assessment within the three-month period provided for in Regulation 258/97, this 
would not imply that the lead CA could not have requested missing information much sooner.  Given 
the three-month maximum assessment period envisage d in Regulation 258/97, and lacking a specific 
justification by the European Communities, we are not convinced that the lead CA could not have 
determined much more promptly than it did whet her additional information was still needed.     
7.2379  We have previously pointed out that the Nether lands was part of the Group of Seven countries 
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing 
with applications for the placing on the market of bi otech products.  However, in this instance, we are 
not convinced that the Dutch CA's conduct reflects a precautionary approach.  Indeed, we are not 
                                                     
 
1653 Exhibit EC-102/At. 32. 
1654 Annex H, paras. 775 and 778.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 841 
  
  convinced that the Dutch CA could not have id entified any need for additional information and 
forwarded an appropriate request for information to the applicant sooner than it did even while 
following a precautionary approach.   
7.2380  Taking account of the aforementioned elements, we consider that upon receipt of the original 
application, the lead CA could, and should, ha ve determined more promptly that additional 
information was needed and could, and should, have forwarded an appr opriate request to the applicant 
more promptly.  
7.2381  We now turn to consider the time taken by the lead CA taken to review the information 
received in December 2000.  To recall, more than  five months after the applicant supplied the 
information requested by the lead CA in May 2000,  the lead CA requested further information on 
protein analysis and a semi-chronic oral toxicity study on rats in order to "to rule out possible 
undesirable effects".  Regarding protein analysis, the lead CA indicated that it was not yet fully 
satisfied with the information previously provided by  the applicant.  Regarding the requested toxicity 
study, the lead CA mentioned recent studies whic h had shown that "unintended effects on GMOs" 
were possibly caused by transformation of plant cells .  However, as noted, no specific study was cited 
in this regard.    
7.2382  Since it is not clear from the record what recen t studies the lead CA was referring to, we have 
no basis on which to determine whether the lead CA could, and should, have put forward its request 
for a toxicity study earlier than it did.   
7.2383  With regard to protein analysis, we note th at the European Communities provides no specific 
justification for why the lead CA required more th an five months to identify a need for yet more 
information.  In the absence of a specific jus tification by the European  Communities, we are not 
convinced that the lead CA could not have eval uated much sooner than it did whether additional 
information on protein analysis was still needed.  We are also of the view that the Dutch CA could 
have requested supplementary information on prot ein analysis at a much earlier date even while 
following a precautionary approach.   
7.2384  Taking account of the aforementioned elements, we  consider that the lead CA could, and 
should, have determined more pr omptly that additional informati on was needed on protein analysis 
and could, and should, have forw arded an appropriate request to the applicant more promptly.  
7.2385  Thus, based on the above considera tions, we conclude that the time taken by the lead CA for 
its assessment of the application concerning RR sugar beet (food) – and in particular the time taken by 
the lead CA before forwarding its first request for additional information as well as the time taken by 
the lead CA to review the information received in December 2000 and to put forward a new request 
for information – was unjustifiably long. 
7.2386  In addition, we recall that the United States claims that the approva l procedure concerning 
NK603 maize (food) was unduly delayed because, due to  the moratorium, the European Communities 
failed to consider the application in question for fi nal approval.  In this respect, we note our earlier 
findings that (i) a general de facto  moratorium on approvals was in effect in the European 
Communities between June 1999 and August 2003 and that  (ii) the time taken by the Netherlands to 
complete its initial assessment of the application co ncerning RR sugar beet (food) is consistent with 
the application of such a moratorium.  In the light of this, and in the absence of effective rebuttal by 
the European Communities, we agr ee with the United States that it is reasonable to infer that the 
Netherlands' conduct was a consequence of  the general moratorium on approvals. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 842 
  
  7.2387  In view of our conclusion with regard to th e time taken by the Netherlands for its initial 
assessment, we do not go on to examine other argumen ts put forward by the United States in support 
of its claim under Annex C(1)(a), fi rst clause, and Article 8 of the SPS Agreement .   
7.2388  Taking account of the aforementioned elements, we  consider that the time taken by the lead 
CA before initially requesting additional information in March 2000, and the time  taken to review the 
information received in December 2000, is consiste nt with the United States' view that a general 
moratorium on final approvals was in effect in the European Communities at that time.  
Conclusion
 
7.2389  In the light of the above, the Panel r eaches the following overall conclusion:  
 (i) DS291 (United States) 
   With reference to DS291, the Panel recalls its findings that the time taken by the lead 
CA for its assessment of the application concerning RR sugar beet (food) – 
particularly the time taken by the lead CA before forwarding its first request for 
additional information as well as the time  taken by the lead CA to review the 
information received in December 2000 and to put forward a new request for information – was unjustifiably long, and that it can reasonably be inferred from 
surrounding circumstances that the lead CA's conduct was a consequence of the 
general moratorium on approvals.  Base d on these findings, the Panel accepts the 
United States' contention that, consistent w ith the general moratorium, the European 
Communities failed to consider the application concerning RR sugar beet (food) for final approval, and that this resulted in "undue delay" in the completion of the 
relevant approval procedure.  Accordingly, the Panel concludes that in respect of the 
approval procedure concerning RR sugar beet (food), the European Communities has 
breached its obligations under Annex C(1)(a ), first clause, and Article 8 of the 
SPS Agreement . 
 (d) Summary of the Panel's conclusions  7.2390  In view of the large number of approval pro cedures reviewed, it is useful to summarize in 
table form the Panel's conclusions on the Complain ing Parties' claim that the European Communities 
has failed to complete the relevant approval pro cedures without undue delay and hence has breached 
its obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement . 
7.2391  We should recall that most of the conclusions id entified in the table are relevant to only one 
or two of the three complaints we are examining.   Our preceding analysis identifies which of these 
conclusions are applicable to which complaint(s).    
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 843 
  
   Approval procedures examined by the Panel Panel's conclusions on 
asserted "undue delay" 
(X: unduly delayed, 
9: not unduly delayed)  
1 Falcon oilseed rape  X 
2 MS8/RF3 oilseed rape X 
3 RR fodder beet X 
4 Bt-531 cotton X 
5 RR-1445 cotton X 
6 Transgenic potato  9 
7 Liberator oilseed rape X 
8 Bt-11 maize (EC-69) X 
9 RR oilseed rape (EC-70) X 
10 LL soybeans (EC-71) X 
11 LL oilseed rape 9 
12 BXN cotton  X 
13 Bt-1507 maize (EC-74) X 
14 Bt-1507 maize (EC-75) X 
15 NK603 maize X 
16 GA21 maize (EC-78) X 
17 MON810 x GA21 maize  X 
18 RR sugar beet  X 
19 MS1/RF1 oilseed rape (EC-89)   X 
20 MS1/RF2 oilseed rape  X 
21 GA21 maize (food) X 
22 Bt-11 sweet maize (food) X 
23 LL soybeans (food) 9 
24 MON810 x GA21 maize (food) X 
25 Bt-1507 maize (food) X 
26 NK603 maize (food) X 
27 RR sugar beet (food) X 
Total:  X: 24 
9:3 
 
10. Consistency of the product-specific measures with Article 8 and Annex C(1)(a), second 
clause, of the SPS Agreement  
7.2392  Argentina claims that the product-specific measure s identified by it are inconsistent with the 
European Communities' obligatio ns under Article 8 and Annex C(1)(a), second clause, of the 
SPS Agreement .    
7.2393  Article 8 of the SPS Agreement  provides: 
"Members shall observe the provisions of  Annex C in the operation of control, 
inspection and approval procedures, includi ng national systems for approving the use 
of additives or for establishing tolerances fo r contaminants in foods, beverages or WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 844 
  
  feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the 
provisions of this Agreement." 
7.2394  Annex C(1)(a), second clause, of the SPS Agreement  provides: 
"Members shall ensure, with respect to any procedure to check and ensure the 
fulfilment of sanitary or phytosanitary measures, that:   
[...] (a) such procedures are undertaken and completed [...] in no less favourable 
manner for imported products than fo r like domestic products[.]"   
7.2395  Argentina  argues that Annex C(1)(a), second clau se, establishes an obligation to avoid 
discriminatory treatment.  Members must not differentiate the treatment granted to an imported product and to a like domestic product.  Argentina submits that in the present case a comparison 
should be made between the manner in which the EC  approval system has been applied in the case of 
biotech products and the manner in which it has been applied in the case of novel non-biotech 
products.  Specifically, Argentina points to Regulation 258/97 which it says defines a procedure that 
does not differ in terms of implementation between th e two products.  According to Argentina, undue 
delays have, however, occurred only in the treatment  of biotech products.  Furthermore, Argentina 
identifies another instance of less favourable treatment of biotech products.  In the view of Argentina, 
prior to 1998, the European Communities granted approvals for the marketing of biotech products, 
whereas it has not done so since,  as a consequence of the general de facto  moratorium on approvals.      
7.2396  The European Communities  argues that the differences in treatment alleged by Argentina 
between biotech products and novel non-biotech pro ducts, and between biotec h products before and 
after the "moratorium", have nothing to do with  the national treatment obligation set forth in 
Annex C(1)(a), second clause.  According to the European Communities, a national treatment issue 
would arise if the European Communities in the a pplication of its approval system treated imported 
biotech products differently from domestic biot ech products.  The European Communities submits 
that this is not the case as all products are being tr eated equally, irrespective of their origin.  The 
European Communities considers, therefore, that Argentina has failed to est ablish an inconsistency 
with Annex C(1)(a), second clause.    
7.2397  The Panel  notes that Argentina relies on the allege d inconsistency of the product-specific 
measures with Annex C(1)(a), second clause, to ma ke consequential claims of inconsistency under 
Article 8.  Accordingly, we will begin our anal ysis with the claims under Annex C(1)(a), second 
clause, before turning to Article 8.   
(a) Annex C(1)(a), second clause 
7.2398  We note that in accordance with the lead-in to Annex C(1) the provisions of Annex C(1)(a) 
apply "with respect to any procedur e to check and ensure the fulfilm ent of sanitary or phytosanitary 
measures".  We have previously found that the pr ocedures set out in Directives 90/220 and 2001/18 as 
well as Regulation 258/97 (to the extent it is an  SPS measure) constitute procedures "to check and 
ensure the fulfilment of sanitary or  phytosanitary measures" within the meaning of Annex C(1) and, 
as such, are subject to the provisions of Annex C(1), which include those of Annex C(1)(a).  
Therefore, the European Communities was and is required under the provisions of Annex C(1)(a) to 
"undertake and complete" the approval procedures set out in Directives 90/220 and 2001/18 as well as  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 845 
  
  Regulation 258/97 (to the extent it is an SPS m easure) "in no less favourable manner for imported 
products than for like domestic products". 
7.2399  Argentina is challenging allege d undue delays in completing the consideration and processing 
of specified applications.  In our view, the type of measure challenged by Argentina could 
conceivably constitute, or lead to, a breach of  the European Communities' obligations under 
Annex C(1)(a), second clause, and it can therefore be  examined in the light of the provisions of 
Annex C(1)(a), second clause.  Since Argentina seeks to establish an inconsistency with Article 8 on 
the basis of an alleged inconsiste ncy with Annex C(1)(a), second clause, this conclusion applies also 
to Article 8. 
7.2400  In order to establish an inc onsistency with Annex C(1)(a), second clause, Argentina must 
establish (i) that imported products have been tr eated in a "less favourable manner" than domestic 
products in respect of the undertaking and comple tion of approval procedures, and (ii) that the 
imported products which are allege d to have been treated less favourably are "like" the domestic 
products which are alleged to have been treated mo re favourably.  If either one of these two elements 
is not met, that is, if imported products have not been treated "less favourably" than the domestic 
products to which they are being compared, or if these domestic products are not "like" the relevant 
imported products, Argentina's claim of inconsistency must fail.  In the circumstances of this case, we 
find it appropriate to begin our analysis with the fi rst element.  Thus, we will examine first whether 
Argentina has demonstrated that imported products  have been treated in a "less favourable manner" 
than domestic products in respect of the undert aking and completion of approval procedures. 
7.2401  We note the phrase "in no less favourable manner".  It is clear from this phrase that 
Annex C(1)(a), second clause, lays down a natio nal treatment obligation.  National treatment 
obligations are found in numerous WTO agreements .  Moreover, the relevant provisions often use 
similar language.  The Appellate Body has confirme d that, in such circumstances, the jurisprudence 
on a national treatment provision in one WTO agreem ent may be useful in interpreting a national 
treatment provision in another WTO agreement.
1655  In the present case, we find it useful to look to 
the jurisprudence on Articles III:1 and III:4 of the GATT 1994 for appropriate interpretative guidance. 
7.2402  Article III:1 provides:1656 
"The contracting parties recognize that intern al taxes and other internal charges, and 
laws, regulations and requirements affecting the internal sale, offering for sale, 
purchase, transportation, distribution or use of products, and internal quantitative 
regulations requiring the mixture, processing or use of products in specified amounts or proportions, should not be applied to impor ted or domestic products so as to afford 
protection to domestic production." 
7.2403  Article III:4 provides in relevant part: 
"The products of the territory of any contr acting party imported into the territory of 
any other contracting party shall be accord ed treatment no less favourable than that 
accorded to like products of national origin  in respect of all laws, regulations and 
requirements affecting their internal sale, offering for sale, purchase, transportation, 
distribution or use." 
                                                     
 
1655 Appellate Body Report, US – Section 211 Appropriations Act , para. 242. 
1656 Ad Note omitted. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 846 
  
  7.2404  In EC – Asbestos , the Appellate Body had this to say on the term "less favourable treatment" 
as it appears in Article III:4:   
"[...] there is a second element [in addition to the 'likeness' of the products being 
'compared] that must be established before a measure can be held to be inconsistent 
with Article III:4. [...] A complaining Memb er must [...] establish that the measure 
accords to the group of 'like'  imported  products 'less favourable  treatment' than it 
accords to the group of 'like' domestic  products.  The term 'less favourable treatment' 
expresses the general principle, in Article III: 1, that internal regulations 'should not be 
applied … so as to afford protection to domestic production'.  If there is 'less 
favourable treatment' of the group of 'like'  imported products, there is, conversely, 
'protection' of the group of 'like' domest ic products.  However, a Member may draw 
distinctions between products which have b een found to be 'like', without, for this 
reason alone, according to the group of 'like' imported  products 'less favourable 
treatment' than that accorded  to the group of 'like' domestic  products.  In this case, we 
do not examine further the interpretation of the term 'treatment no less favourable' in Article III:4, as the Panel's findings on this issue have not been appealed or, indeed, 
argued before us."
1657 
7.2405  Subsequently, in Dominican Republic – Import and Sale of Cigarettes , the Appellate Body 
again addressed the meaning of the phr ase "less favourable treatment", stating  that: 
"[T]he existence of a detrimental [com petitive] effect on a given imported product 
resulting from a measure does not necessarily imply that this measure accords less favourable treatment to imports if the detrim ental effect is explained by factors or 
circumstances unrelated to the foreign origin  of the product, such as the market share 
of the importer in this case."
1658 
7.2406  We recognize that Annex C(1)(a), second clause, does not use the phrase "treatment no less 
favourable", but the phrase "in no less favourable manner".  In our view, there is, however, a close conceptual similarity between these two phrases, a nd the textual difference between them does not, 
therefore, render inapposite appropriate reliance on the Appellate Body's interpretation of the phrase 
"treatment no less favourable" as it appears in Article III:4.   
7.2407  We also recognize that Annex C(1) to the SPS Agreement  does not contain a provision 
analogous to Article III:1 of the GATT 1994.  But the fact that Article III:4 expresses a general 
principle which is explicitly spelt out in Article III:1 does not necessarily mean that a similar general 
principle cannot be implicit in Annex C(1)(a), seco nd clause.  Indeed, we consider that a central 
purpose of the provisions of Annex C(1)(a), second clause, is precisely to prevent Members from applying their approval procedures in a manne r which would afford protection to domestic 
production.  This view is consis tent with Article 2.3 of the SPS Agreement , which is part of the 
context of Annex C(1)(a).  The second sentence of Artic le 2.3, which would appear to be applicable to 
approval procedures, provides that SPS measures "s hall not be applied in a manner which would 
constitute a disguised restriction on international trade".  Thus, we do not think that the absence in 
Annex C(1) of an analogue to Article III:1 should prevent us from being guided by the Appellate 
Body's interpretation of the phrase "treatment no less favourable". 
                                                     
 
1657 Appellate Body Report, EC – Asbestos , para. 100 (emphasis in original). 
1658 Appellate Body Report, Dominican Republic – Import and Sale of Cigarettes , para. 96.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 847 
  
  7.2408  Reading Annex C(1)(a), second clause, in the lig ht of the jurisprudence on Article III:4, we 
consider that in undertaking and completing its ap proval procedures, a Member may, in principle, 
differentiate between products that have been found to be like because this would not, by itself, mean 
that the relevant approval procedures have been undertaken or completed in less favourable manner 
for the group of like imported products than for th e group of like domestic products.  In particular, a 
mere showing that a Member has undertaken or completed a particular approval procedure in a 
manner which is unfavourable for a given imported product would not be sufficient to establish a "less 
favourable manner" of undertaking or completing approval procedures if the relevant Member's 
conduct is explained by factors or circumstances unrelated to the foreign origin of the product. 
7.2409  With these considerations in mind, we now turn to analyse Argentina's arguments.  
Argentina's first argument is that the Europ ean Communities has undertaken approval procedures 
under Regulation 258/97 in less favourable manner fo r the biotech products which are the subject of 
the product-specific measures challenged by Arge ntina than for like novel non-biotech products.  
Argentina asserts that undue delays have occurre d only in the processing of applications concerning 
biotech products.   
7.2410  We note that it is not entirely clear from Arge ntina's submissions which approval procedures 
are at issue.  We understand Argentina to refer to the procedures set out in Articles 4, 6, 7 and 8 of 
Regulation 258/97.  These procedures apply in the same way to biotech products as they do to novel 
non-biotech products.  These procedures also apply equally to imported a nd domestic products.   
Finally, we note that we have previously determ ined that these procedures constitute an approval 
procedure within the meaning of Annex C.  Therefore, in undertaking and completing these 
procedures, the European Communities must comply with Annex C(1)(a), second clause. 
7.2411  Turning to the merits of Argentina's argument , we observe, initially, that Argentina has not 
provided factual information about the processing of  applications concerning those novel non-biotech 
products which Argentina considers to be like the biot ech products at issue.  At  any rate, even if it 
were the case, as Argentina seems to assert, that th e processing of applications concerning the relevant 
imported biotech products ( e.g., imported biotech maize) has been unduly delayed, while the 
processing of applications concerning the corresponding domestic non-biotech varieties ( e.g., 
domestic novel non-biotech maize) has not been unduly delayed, this would not be sufficient, in and of itself, to raise a presumption that the procedur es envisaged in Regulation 258/97 have been applied 
in less favourable manner for the group of like importe d products than for the group of like domestic 
products.  Argentina does not assert that the processi ng of applications con cerning relevant domestic 
biotech products ( e.g., domestic biotech maize) has not been unduly delayed, or that the processing of 
applications concerning correspondi ng imported non-biotech varieties ( e.g., imported novel non-
biotech maize) has been unduly delayed.  In other words, Argentina is not alleging that the manner of 
processing applications under Regul ation 258/97 has differed depending on the origin of the products.  
In these circumstances, it is not self-evident th at the alleged less favourable manner of processing 
applications concerning the rele vant imported biotech products ( e.g
., imported biotech maize) is 
explained by the foreign origin of these products rather than, for instance, a perceived difference 
between biotech products and novel no n-biotech products in terms of the required care in their safety 
assessment, risk for the consumer, etc.  Argentin a has not adduced argument and evidence sufficient 
to raise a presumption that the alleged less favourable  treatment is explained by the foreign origin of 
the relevant biotech products.  
7.2412  In the light of the above, we find that Ar gentina has not established that the approval 
procedures set out in Regulation 258/97 have been undertaken or completed in a less favourable 
manner for imported products than for domestic products. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 848 
  
  7.2413  Argentina's second argument is that after 1998 the European Communities has applied its 
approval procedures in a less favourable manner for the biotech products which are the subject of the product-specific measures challenged by Argentina than for like biotech products before 1998.  More 
particularly, Argentina submits that after 1998 und ue delays have occurred in the processing of 
applications under the relevant approval procedures.  The year 1998 is the year in which, in 
Argentina's view, the European Communities began applying its general de facto  moratorium on 
approvals.   
7.2414  We understand Argentina's second argu ment to relate to the approval procedures contained in 
Directives 90/220 and 2001/18 as well as Regulation 258/97.  Directives 90/220 and 2001/18 as well 
as Regulation 258/97 apply equally to  imported and domestic biotech pr oducts.  We have previously 
determined that these pieces of legislation contai n approval procedures within the meaning of 
Annex C.  Therefore, in undertaking and comp leting these approval procedures, the European 
Communities was and is required to comply with Annex C(1)(a), second clause.  We note that 
Directive 2001/18 is formally and, to some extent, substantively different from Directive 90/220.  
Argentina appears to assume that the obligation laid down in Anne x C(1)(a), second clause, applies 
not only in situations where imported and domestic  products are dealt with under one and the same 
approval procedure, but also in situations wher e like products are dealt with under formally or 
substantively different approval procedures.  For the purposes of our analysis of Argentina's 
argument, we are prepared to pro ceed on the basis of this assumption, but we do not make a finding in 
this regard.   
7.2415  It seems to us that Argentina wishes to argue, in  effect, that approval procedures were applied 
in less favourable manner for relevant imported biotech products after 1998 than for like domestic 
biotech products before 1998.  Even if this were co rrect as a factual matter, however, this would not 
be sufficient, in and of itself, to raise a presump tion that the approval procedures at issue have been 
applied in less favourable manner for the group of li ke imported products than for the group of like 
domestic products.  Argentina asserts that after 1998 applications concerning the relevant biotech 
products were processed in less favourable manner, i rrespective of whether they were of foreign or 
domestic origin, and that before 1998 applicati ons concerning biotech products were processed in 
more favourable manner, irrespective of whether they were of foreign or domestic origin.  Thus, it is 
not Argentina's contention that there has been a di fference, before and after 1998, in the manner in 
which the European Communities has processed applications concerning imported biotech products 
and the manner in which it has processed applicati ons concerning domestic biotech products.  It is 
therefore not obvious that the alleged less favour able manner of conducting approval procedures for 
the relevant imported biotech products after 1998 is explained by the foreign origin of these products 
rather than by other factors or circumstances, such  as a different perception of risks associated with 
biotech products, etc.  Argentina has not adduc ed argument and evidence sufficient to raise a 
presumption that the alleged less favourable treatment  is explained by the foreign origin of the 
relevant biotech products. 
7.2416  Additionally, we note that one of the conse quences of accepting Argentina's second argument 
would be that Members could not consistently w ith Annex C(1)(a), second clause, elect to conduct 
their approval procedures in a less favourable manner  for all subject products regardless of their 
origin, e.g., in response to new scientif ic evidence suggesting that th e risks associated with the 
products subject to the approval requirement had pr eviously been underestimated.  In our view, it 
would be unreasonable to interpret Annex C(1)(a ), second sentence, so as to produce such an 
outcome. 
7.2417  In the light of the above, we are not persuaded by Argentina's argument that the European 
Communities has undertaken and completed its approva l procedures in a less favourable manner for  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 849 
  
  imported products than for domestic  products by processing applicati ons concerning biotech products 
in a less favourable manner after 1998 than before 1998. 
7.2418  Since we have found that Argentina has not de monstrated to our satisfaction that imported 
products have been processed in a "less favourable manner" than domestic products in respect of the 
undertaking and completion of approval procedures, th ere is no need to go on to examine whether the 
imported products which Argentina alleges have been treated less favourably are "like" the domestic 
products which Argentina alleges have  been treated more favourably.   
7.2419  Based on all of the above considerations, we c onclude that Argentina has failed to establish 
its product-specific claims under Annex C(1)(a), second clause.    
(b) Article 8 
7.2420  Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an 
inconsistency with Article 8 on the basis of an alleged inconsistency with  Annex C(1)(a), second 
clause.  We have determined that Argentina has failed to establish its claims under Annex C(1)(a), 
second clause.  Under the approach followed by Argen tina, this means that its claims under Article 8 
have not been established either.   
(c) Overall conclusion  
7.2421  In the light of the above, the Panel reaches the following conclusion:  
 (i) DS293 (Argentina) 
 
  With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the product-specific measures in respect of which the Panel is making findings have resulted in the Eur opean Communities acting inconsistently 
with its obligations under Annex C(1)(a), second clause, of the SPS Agreement  and, 
consequently, with its obliga tions under Article 8 of the SPS Agreement .   
 
11. Consistency of the product-specific measures with Article 8 and Annex C(1)(b) of the 
SPS Agreement  
7.2422  The United States and Argentina claim that the product-specific measure s identified by them 
are inconsistent with the European Communities' obligations under Article 8 and Annex C(1)(b) of 
the SPS Agreement .    
7.2423  Article 8 of the SPS Agreement  provides: 
"Members shall observe the provisions of  Annex C in the operation of control, 
inspection and approval procedures, includi ng national systems for approving the use 
of additives or for establishing tolerances fo r contaminants in foods, beverages or 
feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the 
provisions of this Agreement." WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 850 
  
  7.2424  Annex C(1)(b) of the SPS Agreement  provides: 
"Members shall ensure, with respect to any procedure to check and ensure the 
fulfilment of sanitary or phytosanitary measures, that:   
[...] 
(b) the standard processing period of each procedure is published or that the 
anticipated processing period is communicated  to the applicant upon request;  when 
receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all 
deficiencies;  the competent body transm its as soon as possible the results of the 
procedure in a precise and complete manner to  the applicant so that corrective action 
may be taken if necessary;  even when the application has deficiencies, the competent 
body proceeds as far as practicable with the procedure if the applicant so requests;  
and that upon request, the applicant is inform ed of the stage of the procedure, with 
any delay being explained[.]" 
7.2425  As we have noted earlier, Annex C(1)(b) essen tially sets out five separate, but related, 
obligations to be observed by Members in the ope ration of approval procedures.  These obligations 
relate to: 
 (i) the publication or communication to a pplicants of the processing period of each 
procedure; 
 
 (ii) the examination of the completeness of the documentation and the communication to 
applicants of deficiencies; 
  (iii) the transmission of the results of the procedure; 
 
 (iv) the processing of applications which have deficiencies; and   (v) the provision of information about the st age of a procedure and the provision of an 
explanation of any delay.  
 
7.2426  The United States  argues that under the relevant product-specific measures – the product-
specific moratoria – the European Communities does not allow its approval procedures to proceed to 
conclusion.  As such, the product-specific morato ria are inconsistent with each of the related 
procedural obligations in Annex C(1)(b) a nd, consequently, with Article 8 as well. 
7.2427  Regarding the first obligation  (publication or communication of processing period), the 
United States submits that although the applicable  EC approval legislation contains processing 
periods, under the product-specific moratoria those processing periods are not followed.  Instead, the 
European Communities has imposed an indefinite de lay.  However, since the European Communities 
does not acknowledge the product-specific moratoria, the standard processing pe riod is not published, 
and the anticipated processing period is  not communicated to the applicant. 
7.2428  Regarding the second  obligation  (completeness of documentation), the United States argues 
that under the product-specific moratoria the European Communities does not promptly examine 
documentation and inform the applicant of all defici encies.  To the contrary, applications under the 
applicable EC legislation are stalled, without e xplanation.  More specifically, the United States  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 851 
  
  submits that in the Bt-531 cotton, RR-1445 cotton, MS1/RF1 oilseed rape (EC 89) and MS1/RF2 
oilseed rape applications, the applicant was not in formed in a precise and complete manner of all 
deficiencies.  To the contrary, when the Regulator y Committee fails to approve an application by 
qualified majority vote, or when the Commission enters  into inter-service consultations rather than 
sending an application on to the Council, the ap plicant is given no explanation, and thus no 
opportunity to correct any deficiencies.  The same is  true when, as for the oilseed rape products, the 
lead member State fails to take the final step of placing the product on the market. 
7.2429  Regarding the third  obligation  (transmission of results), the United States argues that under 
the product-specific moratoria results of procedures ar e not promptly communicated to applicants so 
that corrective action may be taken.  Instead, app lications are stalled in the approval process without 
explanation.  More specifically, the United States submits that in the Bt-531 cotton, RR-1445 cotton, 
MS1/RF1 oilseed rape (EC 89) and MS1/RF2 oil seed rape applications, the applicant was not 
informed in a precise and complete manner of all de ficiencies.  To the cont rary, when the Regulatory 
Committee fails to approve an application by qualif ied majority vote, or when the Commission enters 
into inter-service consultations rather than sending an application on to the Council, the applicant is 
given no explanation, and thus no opportunity to corr ect any deficiencies.  The same is true when, as 
for the oilseed rape products, the l ead member State fails to take the final step of placing the product 
on the market. 
7.2430  Regarding the fourth  obligation  (processing of deficient applications), the United States 
argues that under the product-specific moratoria th e European Communities does not proceed as far as 
practicable in the approval process.  Instead, app lications are stalled in the approval process. 
7.2431  Regarding the fifth obligation  (explanation of delay), the United States argues that under the 
product-specific moratoria delays are not explained.   To the contrary, the European Communities does 
not even inform applicants of the existence of the general moratorium. 
7.2432  Argentina  argues that Annex C(1)(b) stipulates obliga tions of publication and notification of 
the applicant and requires the competent bodies of Members to perform their obligations "promptly" and to explain "any delay".  Argentina considers that the undue delay which has been caused by the 
European Communities in the specific approval pro cedures identified by it is inconsistent with 
Article 8 and Annex C(1)(b).  Argentina submits  that the European Communities has not ensured 
compliance with the requirements of Annex C(1)(b ) because in some cases the relevant EC entity did 
not promptly determine whether the documentati on was complete (second obl igation), and in other 
cases did not inform the applicant of  the results of the procedure (thi rd obligation) or of the current 
stage of the procedure (fifth obligation).  Argentina ar gues in this regard that it has demonstrated that, 
for instance, in the approval procedure concerni ng GA21 maize (EC-78) the applicant was still 
waiting for a definitive answer with respect to its a pplication after more than five years.  Finally, 
Argentina submits that a violation of the provisions  of Annex C simultaneously represents a violation 
of Article 8.   
7.2433
 The European Communities  submits that the United States and Argentina have offered a 
mere assertion that the European Communities h as not done what it is required to do under the 
different obligations contained in Annex C(1)(b).  Argentina has offered no evidence in support of its 
allegations.  The United States also considers it suffi cient simply to allege that applications were 
stalled in the approval process and gives no explanatio ns.  However, it is a complaining party's burden 
to establish a prima facie case.  In any event, the detailed ch ronologies of individual approval 
procedures and other documents submitted by the European Communities demonstrate that the 
allegations of the United States are unfounded.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 852 
  
  7.2434  Regarding the United States' claim that no st andard processing periods have been published 
for the "product-specific morato ria", the European Communities ar gues that these "moratoria" are 
individual applications subject to their own particular  facts.  In the European Communities' view, it is 
difficult to see how a "standard" processing period othe r than the one laid down in the legislation 
could be set out for these applications collectively.  
7.2435  The Panel  notes that in accordance with the lead-in to Annex C(1) the provisions of 
Annex C(1)(b) apply "with respect to any procedure to  check and ensure the fulfilment of sanitary or 
phytosanitary measures".  We have previously found  that the procedures set out in Directives 90/220 
and 2001/18 as well as Regulation 258/97 (to the extent  it is an SPS measure) constitute procedures 
"to check and ensure the fulfilment of sanitary or  phytosanitary measures" within the meaning of 
Annex C(1) and, as such, are subject to the pr ovisions of Annex C(1), which include those of 
Annex C(1)(b).  Therefore, in respect of the approval procedures set out in the aforementioned 
Directives and Regulation, the European Communi ties was and is required to comply with the 
provisions of Annex C(1)(a). 
7.2436  We recall that the United States is challe nging the alleged failure by the European 
Communities to consider particular applications for final approval.  We have observed in this regard 
that this is essentially a challenge to the applicati on by the European Communities of a particular way 
of operating the relevant EC appr oval procedures.  We also recall that Argentina is challenging 
alleged undue delays in completi ng the consideration and processing of specified applications. 
7.2437  In our view, the type of measure challenge d by the United States and Argentina could 
conceivably constitute, or lead to, a breach of EC obligations under Annex C(1)(b), and it can 
therefore be examined in the light of the provisi ons of Annex C(1)(b).  Since the United States and 
Argentina seek to establish an inconsistency with Article 8 on the basis of an alleged inconsistency 
with Annex C(1)(b), this conclusion applies also to Article 8. 
7.2438  In view of the fact that the United States' and Argentina's claim under Article 8 is in the 
nature of a consequential claim, we will begin our analysis with the claims under Annex C(1)(b).   
(a) First obligation in Annex C(1)(b) (publica tion or communication of processing period)  
7.2439  Only the United States has presented arguments in  relation to the first obligation contained in 
Annex C(1)(b).  Specifically, the United States puts forward two main arguments.  The first argument 
is that as a result of the European Communities' fa ilure to consider the relevant applications for 
approval, the European Communities did not foll ow the standard processing periods which are 
published in the applicable EC approval legislation.  The United States appears to infer from this that 
the effective standard processing period was not published.   
7.2440  We agree with the European Communities that th e first obligation in Annex C(1)(b) does not, 
and logically cannot, require the European Comm unities to publish a "standard" processing period for 
every individual approval procedure undertaken by it.  The processing period to be published is the 
period which is intended to be the norm for a ll approval procedures of a particular type, e.g., the 
approval procedures envisaged in Di rective 2001/18 for the placing on the market of biotech products.  
This follows from the word "standard", which in th e specific context of the first obligation should be 
understood as meaning "normal".
1659  However, we do not understand the United States to argue that 
                                                      
1659 The dictionary defines "standard" as "[o]f a pr escribed or normal size, amount, quality, etc.".  The 
New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993),  Vol. II, p. 3028.  The French  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 853 
  
  the European Communities should have published a standard processing period for each individual 
approval procedure conducted by it.   
7.2441  We understand the United States to argue that the failure by the European Communities to 
consider a particular application for final appr oval meant that it was not following the published 
standard processing period for the relevant type of procedure and that the effective standard 
processing period for the relevant type of procedure was no longer published.  Even if we were to 
accept that what has to be publishe d in accordance with the first obligation in Annex C(1)(b) is the 
"effective" standard processing period, the mere fact  that the European Communities in one particular 
approval procedure might not have  followed the published standard  processing period would not, by 
itself, justify the conclusion that there was a new and unpublished effec tive "standard" processing 
period.  A single departure from the published st andard processing period in our view does not 
demonstrate the existence of a new "standard" processing period.
1660  In any event, even if there was a 
new standard processing period, the fact that it wa s unpublished would not be a consequence of the 
failure by the European Communities to consider the relevant application for fi nal approval.  In other 
words, it would not be a consequence of the product- specific measure at issue.  Rather, it would be a 
consequence of a separate and independent failure  by the European Communities to publish the new 
standard processing period.   
7.2442  In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the first obligation contained in  Annex C(1)(b), insofar as these claims are based 
on the requirement to publish the standard processing period of each procedure.   
7.2443  The United States' second argument in support of its claim under Annex C(1)(b) is that since 
the European Communities does not acknowledge its failu re to consider the relevant applications for 
approval, the anticipated processing period is not communicated to the applicants.  We note that 
pursuant to Annex C(1)(b) the anticipated processing period is to be communicated to the applicant 
"upon request".  The United States has provided no ev idence to show (i) that an applicant requested  
that the anticipated processing period be communicated to it, (ii) that the request was denied by a 
relevant EC entity, and (iii) that this was becaus e of a deliberate failure to consider the relevant 
applications for approval.  Moreover, we do not thin k that the failure by the European Communities to 
consider particular applications for final approva l necessarily resulted in the European Communities 
not communicating to applicants the anticipated processing periods upon request.  Indeed, in our 
view, the fact that the European Communities may have prevented a partic ular approval procedure 
from proceeding to conclusion would not have made it impossible for the European Communities to communicate to the applicant the anticipated  processing period upon request, as required by 
Annex C(1)(b).   
7.2444  In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the first obligation contained in  Annex C(1)(b), insofar as these claims are based 
on the requirement to communicate to appli cants the anticipated processing period.   
(b) Second obligation in Annex C(1)(b) (completeness of documentation)  
7.2445  Concerning the second obligation contained in Annex C(1)(b), both the United States and 
Argentina have presented arguments.  We begin our analysis with th e United States' arguments.   
                                                                                                                                                                    
 
("la durée normale") and Span ish ("el período normal de tramitación") versions of the SPS Agreement  support 
this interpretation. 
1660 We recall that the measures at issue are indivi dual product-specific measures, and not the product-
specific measures collectively or the general moratorium on approvals. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 854 
  
  7.2446  The United States argues that as a result of the Eu ropean Communities' failure to consider the 
relevant applications for approval, the Eur opean Communities did not promptly examine the 
completeness of documentation and inform applicants of any deficiencies.  The United States has 
identified individual approval procedures whic h it believes support its claim under the second 
obligation.   
7.2447  Among the applications referred to by the United States are those concerning MS1/RF1 
oilseed rape (EC 89) and MS1/RF2 oilseed rape.  We  have determined above that there are twenty-
five product-specific measures on which the Unite d States is seeking findings.  However, the 
applications concerning MS1/RF1 oilseed rape (EC 89) and MS1/RF2 oilseed rape are not part of 
these twenty-five measures.  We are therefore not  entitled to make product-specific findings on these 
two applications concerning oilseed rape. 
7.2448  The United States also refers to the app lications concerning Bt-531 cotton and RR-1445 
cotton.  They are among the applications which are the subject of product-specific claims put forward 
by the United States.  In relation to these app lications, the United States argues that when the 
Regulatory Committee failed to approve them by a qualified majority vote, or when the Commission 
entered into inter-service consultations after the Regulatory Committee vote, the applicant was given 
no explanation, and thus no opportunity to correct a ny deficiencies.  As an initial matter, we note that 
the second obligation in Annex C(1)(b) applies when a "competent body" "receives" an application.  
In our view, the competent body receiving the a pplications concerning Bt-531 and RR-1445 cotton 
was the lead member State to whic h these applications were submitte d for initial assessment, not the 
Regulatory Committee or the Commission at the post-Regulatory Committee stage.   
7.2449  In any event, the United States has not demonstr ated that either the Regulatory Committee or 
the Commission identified deficiencies in the docum entation submitted by the applicant and did not 
inform the applicant thereof in a precise and comp lete manner.  We recall that in the case of the 
application concerning Bt-531 cotton, three member States made written statements in support of their 
votes in the Regulatory Committee in February 1999, and that the applicant provided additional information more than two years after the Regul atory Committee meeting and the launching by the 
Commission of inter-service consultations.  The United  States has not shown that any of the member 
State statements identified deficiencies in the doc umentation submitted by the applicant.  We have 
found earlier that none of the member State statemen ts specifically called for the provision of the 
additional information and that there is no indi cation that the applicant submitted the additional 
information in response to the written statements.  We also recall our earlier finding that there is no 
evidence to suggest that the Commission was waiting for the additional information provided by the 
applicant and for that reason did not submit a draf t measure to the Council.  We therefore do not 
consider that the additional information provided by  the applicant addressed "deficiencies" which had 
been identified by the Regulato ry Committee or the Commission. 
7.2450  Regarding the application concerning RR-1445 cott on, we note that as in the case of the 
application concerning Bt-531 cotton, a number of member States made written statements in support 
of their votes in the Regulatory Committee in Febr uary 1999.  The United States has not shown that 
any of these statements identified deficiencies in  the documentation submitted by the applicant.  
Moreover, we have found earlier that the record of  the consultation of the Regulatory Committee does 
not contain any indication of a request to the appli cant for further information.  In fact, no further 
information was provided subsequent to the Regul atory Committee vote.  Finally, the United States 
itself points out in a different context that not hing in the record indi cates that the Commission 
communicated any scientific concerns to the appl icant or identified any shortcomings in the 
application following the Regulatory Committee vote.  We therefore consider that the United States 
has not demonstrated that either the Regulatory Committee or the Commission identified deficiencies  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 855 
  
  in the documentation submitted by the applicant and did not inform the applicant thereof in a precise 
and complete manner.   
7.2451  By way of an additional consideration, we not e that the failure by the European Communities 
to consider particular applications for final a pproval did not necessarily result in the European 
Communities not examining promptly the comple teness of documentation and not informing 
applicants of any deficiencies.  Indeed, in our vi ew, the fact that the European Communities may have 
prevented a particular approval procedure from pr oceeding to conclusion w ould not have made it 
impossible for the European Communities to exam ine the completeness of the documentation or 
inform the applicant of deficiencies in the doc umentation submitted, as required by Annex C(1)(b).
1661   
7.2452  In the light of the above considerations, we c onclude that the United States has failed to 
establish its product-specific claims under the second obligation contained in Annex C(1)(b).    
7.2453  Argentina submits that the European Comm unities has not ensured compliance with the 
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not promptly 
determine whether the documentation was complete.  Argentina has failed specifically to identify 
these "cases" and has not demonstrated that in these cases the competent body found deficiencies in 
the documentation submitted by the applicant and did not inform the applicant thereof in a precise and 
complete manner.   
7.2454  In the light of this, we conclude that Arge ntina has failed to establish its product-specific 
claims under the second obligation cont ained in Annex C(1)(b).    
(c) Third obligation in Annex C(1)(b) (transmission of results) 
7.2455  With regard to the third obligation contained in Annex C(1)(b), both the United States and 
Argentina have presented arguments.  We begin our analysis with the United States' arguments.     
7.2456  The United States argues that as a result of the Eu ropean Communities' failure to consider the 
relevant applications for approval, the Europ ean Communities did not promptly communicate the 
results of procedures to applicants so that correc tive action could be taken if necessary.  The United 
States has identified individual approval procedures which it believes support its claim under the third obligation.  Among the applications referred to by the United States are those concerning MS1/RF1 
oilseed rape (EC 89) and MS1/RF2 oilseed rape.  We  have already determined that we are not entitled 
to make product-specific findings on the two a pplications concerning oilseed rape.   
7.2457  The United States also refers to the app lications concerning Bt-531 cotton and RR-1445 
cotton.  They are among the product-specific measures challenged by the United States.  In relation to 
these approval procedures, the United States argues that when the Regulatory Committee failed to approve them by a qualified majority vote, or  when the Commission entered into inter-service 
consultations after the Regulatory Committee vote, th e applicant was given no explanation, and thus 
no opportunity to correct any deficiencies.   
7.2458  We note at the outset that when the applications concerning Bt-531 and RR-1445 cotton 
reached the Regulatory Committee stage, they were subject to Directive 90/220.  It is clear from Article 21 of Directive 90/220 that the role of th e Regulatory Committee is to assist the Commission 
in its decision-making by delivering opinions on draft measures proposed by the Commission.  The 
                                                     
 
1661 We note in this regard that certain progress in  the approval process is not inconsistent with a 
deliberate failure by the European Communities to move a particular application to final decision. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 856 
  
  Regulatory Committee cannot by itself take decisions on applications.  Moreover, Directive 90/220 
does not provide for the applicant to be given an explanation of the vote.
1662  Indeed, we have noted 
earlier that there is no publicly available record of Regulatory Committee votes.  The European 
Communities has pointed out in this regard that Regulatory Committee votes have no external legal 
effect and cannot, therefore, be challenged under EC law.1663  Thus, there is no "corrective action" 
which can be taken by the applicant in response to an unfavourable Regulatory Committee vote.  For 
all these reasons, we are not persuaded that a vote in the Regulatory Committee can be considered a "result of the procedure" within the meaning of the third obligation contained in Annex C(1)(b).  In 
our view, the Regulatory Committee vote is rather a "s tage of the procedure" of which the applicant 
must be informed upon request in accordance with the fifth obligation in Annex C(1)(b).    
7.2459  We believe that the same is true for inter-ser vice consultations held by the Commission prior 
to the submission of a draft measure to the Coun cil.  Such consultations are a "stage of the 
procedure", not a "result of the procedure".  At any rate, the outcome of such consultations is a draft 
measure to be transmitted to the Council for ac tion, not a decision on an application.    
7.2460  Based on the preceding considerations, we find that the Regulatory Committee votes and the 
opening of inter-service consultations by the Co mmission in the approval procedures concerning 
Bt-531 and RR-1445 cotton were not "results" whic h the European Communities was required to 
transmit to the applicant.   
7.2461  More generally, we note that the failure by the European Communities to consider particular 
applications for final approval meant that no final results were achieved.  Thus, there were no final 
results which could have been communicated to applicants as required by the third obligation in 
Annex C(1)(b).
1664 
7.2462  In the light of the above, we conclude that th e United States has failed to establish its product-
specific claims under the third obligation contained in Annex C(1)(b).    
7.2463  Argentina submits that the European Comm unities has not ensured compliance with the 
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not inform the 
applicant of the results of the procedure.  Arge ntina has failed specifically  to identify these "cases" 
and has not demonstrated that in these cases there we re "results" which needed to be transmitted to the 
applicants.  We note that Argentina has referred to the fact that in the approval procedure concerning 
GA21 maize (EC-78), the applicant was still waiting fo r a definitive answer regarding its application 
after more than five years.  We recall in this rega rd that the third obligation in Annex C(1)(b) requires 
the competent body to "transmit" as soon as possible "the results of the procedure" in a precise and 
complete manner to the applicant so that corrective action may be taken if necessary.  Thus, the third 
obligation applies in situations where results have been reached.1665  Argentina's example is one where 
no final results have been reached yet.  Since no results have been reached, none could be transmitted 
                                                      
1662 It is important to recall in this context that the United States is not alleging that Directive 90/220 is, 
as such, WTO-inconsistent. 
1663 In support of its statement, the European Commun ities refers to the jurisprudence of the European 
Court of First Instan ce, case T-326/99, Nancy Fern Olivieri v. Commission and EMEA , decision of 
18 December 2003, paras. 51 et seq . 
1664 As is clear from the discussion of the approval procedures concerning Bt-531 and RR-1445 cotton, 
the United States has failed to establish that "results" other than the final results of the relevant procedures had 
to be transmitted to the relevant applicants and that those results were not transmitted to them. 
1665 We note that the requirement in Annex C(1)(a), first clause, that approval procedures be 
"completed" without undue delay serves to ensure that "results" are reached.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 857 
  
  to the applicant.  In our view, the example of the approval procedure concerning GA21 maize (EC-78) 
does not, therefore, assist Argentina in establishi ng an inconsistency with the third obligation. 
7.2464  In the light of this, we conclude that Arge ntina has failed to establish its product-specific 
claims under the third obligation contained in Annex C(1)(b).    
(d) Fourth obligation in Annex C(1)(b) (processing of deficient applications) 
7.2465  Only the United States has presented arguments in  relation to the fourth obligation contained 
in Annex C(1)(b).  The United States argues that as a result of the European Communities' failure to 
consider the relevant applicati ons for approval, the European Co mmunities did not proceed as far as 
practicable in the approval process.   
7.2466  We note that pursuant to Annex C(1)(b) the comp etent body is to proceed as far as practicable 
with the procedure "if the applicant so requests" .  The United States has provided no evidence of an 
applicant making such a request and of a relevant EC entity denying that request because of a decision 
by the European Communities not to consider the relevant applicati on for final approval.  Moreover, 
we do not think that the failure by the European Co mmunities to consider particular applications for 
final approval necessarily resulted in the European  Communities not proceeding as far as practicable 
with procedures if applicants so requested.  I ndeed, in our view, the fact that the European 
Communities may have prevented a particular a pproval procedure from proceeding to conclusion 
would not have made it impossible for the Europ ean Communities to proceed as far as practicable 
with that procedure upon request, as required by Annex C(1)(b).
1666   
7.2467  In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the fourth obligation contained in Annex C(1)(b).    
(e) Fifth obligation in Annex C(1)(b) (explanation of delay) 
7.2468  Regarding the fifth obligation contained in Annex C(1)(b), both the United States and 
Argentina have presented arguments.  We begin our analysis with th e United States' arguments.   
7.2469  The United States argues that as a result of the Eu ropean Communities' failure to consider the 
relevant applications for approval,  delays were not explained.  The fifth obligation states that "upon 
request", the applicant is to be informed of the stag e of the procedure, with an y delay being explained.  
The United States has provided no evidence of an a pplicant making such a request, or of a relevant 
EC entity denying an explanation of any delay b ecause of a deliberate failure by the European 
Communities to consider the relevant application fo r approval.  Moreover, we do not think that the 
failure by the European Communities to consider pa rticular applications for final approval necessarily 
resulted in the European Communities not informing applicants of the stage of procedures and not 
explaining any delays, if applicants so requested.  Indeed, in our view, the fact that the European 
Communities may have prevented a particular a pproval procedure from proceeding to conclusion 
would not have made it impossible for the European Communities to inform app licants of the stage of 
procedures and explain any delays, as required by Annex C(1)(b).   
7.2470  In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the fifth obligation contained in Annex C(1)(b).    
                                                      
1666 We note in this regard that certain progress in  the approval process is not inconsistent with a 
deliberate failure by the European Communities to move a particular application to final decision. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 858 
  
  7.2471  Argentina submits that the European Comm unities has not ensured compliance with the 
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not inform the 
applicant of the current stage of the procedure.  Argentina has failed specifically to identify these 
"cases" and has not demonstrated that the relevant applicants requested information about the stage of 
the procedure and were denied such information.   
7.2472  In the light of this, we conclude that Arge ntina has failed to establish its product-specific 
claims under the fifth obligation contained in Annex C(1)(b).    
(f) Article 8  
7.2473  Turning now to the United States' and Argentina' s claims under Article 8, we recall that the 
United States and Argentina seek to establish an inconsistency with Article 8 on the basis of an 
alleged inconsistency with  Annex C(1)(b).  We have determined  that the United States and Argentina 
have failed to establish their clai ms under Annex C(1)(b).  Under th e approach followed by the United 
States and Argentina, this means th at their claims under Article 8 have not been established either.   
(g) Overall conclusions  
7.2474  In the light of the above, the Panel reaches the following conclusions:  
 (i) DS291 (United States) 
   With reference to DS291, and having rega rd to the arguments and evidence submitted 
by the United States and the European Co mmunities, the Panel concludes that the 
United States has not established that th e product-specific measures in respect of 
which the Panel is making findings have  resulted in the European Communities 
acting inconsistently with its oblig ations under Annex C(1)(b) of the SPS Agreement  
and, consequently, with its oblig ations under Article 8 of the SPS Agreement .    
 
 (ii) DS293 (Argentina) 
   With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the product-specific measures in respect of which the Panel is making findings have resulted in the Eur opean Communities acting inconsistently 
with its obligations under Annex C(1)(b) of the SPS Agreement  and, consequently, 
with its obligations under Article 8 of the SPS Agreement .   
 
12. Consistency of the product-specific measures with Article 8 and Annex C(1)(c) of the 
SPS Agreement  
7.2475  Argentina claims that the product-specific measure s identified by it are inconsistent with the 
European Communities' obligations under  Article 8 and Annex C(1)(c) of the SPS Agreement .    
7.2476  Article 8 of the SPS Agreement  provides: 
"Members shall observe the provisions of  Annex C in the operation of control, 
inspection and approval procedures, includi ng national systems for approving the use 
of additives or for establishing tolerances fo r contaminants in foods, beverages or  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 859 
  
  feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the 
provisions of this Agreement." 
7.2477  Annex C(1)(c) of the SPS Agreement  provides: 
"Members shall ensure, with respect to any procedure to check and ensure the 
fulfilment of sanitary or phytosanitary measures, that:   
[...] (c) information requirements are limited to what is necessary for appropriate 
control, inspection and approval procedures,   including for approval of the use of 
additives or for the establishment of toleran ces for contaminants in food, beverages or 
feedstuffs[.]"   
7.2478  Argentina  submits that the European Communities act ed inconsistently with the provisions 
of Annex C(1)(c) by delaying the examination of th e relevant applications and by requiring excessive 
submissions under the terms of subsequent legislat ion.  Regarding the submission of information 
under the terms of subsequent legislation, Argen tina points out that the European Communities has 
invoked requirements contained in subsequent legislation as grounds for not processing applications.  
According to Argentina, this is clear from the f act that applications submitted under Directive 90/220 
had to be resubmitted under Directive 2001/18 even in cases where the procedures had already been 
in progress under the old Directive for three years.   Argentina also points out that there were 
numerous requests for additional information in the approval procedures which are the subject of its 
product-specific claims under Annex C(1)(c).  Finally, Argentina argues that a violation of the 
provisions of Annex C simultaneously represents a violation of Article 8.   
7.2479  The European Communities  argues that delays do not fall within the scope of application of 
Annex C(1)(c).  Regarding information requireme nts, the European Communities submits that the 
question of which information requirements are necess ary is a question of standards set forth in the 
SPS Agreement  itself.  The European Communities also argues that Argentina should have attacked 
Directive 2001/18 if it considered the requirement  to resubmit an updated dossier upon entry into 
force of Directive 2001/18 to be inconsistent with the SPS Agreement .  
7.2480  The Panel  notes that in accordance with the lead-in to Annex C(1) the provisions of 
Annex C(1)(c) apply "with respect to any procedure to  check and ensure the fulfilment of sanitary or 
phytosanitary measures".  We have previously found  that the procedures set out in Directives 90/220 
and 2001/18 as well as Regulation 258/97 (to the extent  it is an SPS measure) constitute procedures 
"to check and ensure the fulfilment of sanitary or  phytosanitary measures" within the meaning of 
Annex C(1) and, as such, are subject to the pr ovisions of Annex C(1), which include those of 
Annex C(1)(c).  Therefore, in respect of the approval procedures set out in the aforementioned 
Directives and Regulation, the European Communi ties was and is required to comply with the 
provisions of Annex C(1)(c). 
7.2481  We note that Argentina relies on the alleged in consistency of the re levant product-specific 
measures with Annex C(1)(c) to make consequentia l claims of inconsistency under Article 8.  
Accordingly, we will begin our analysis with the claims under Annex C(1)(c).   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 860 
  
  (a) Annex C(1)(c) 
7.2482  We recall that the product-specific measure s which Argentina says give rise to an 
inconsistency with Annex C(1)(c ) are undue delays caused by the European Communities in the 
consideration of particular applications.  Arge ntina asserts that the European Communities has 
breached its obligations under Annex C(1)(c) by de laying the completion of the relevant approval 
procedures.  We are not persuaded by this asserti on.  In our view, the failure by the European 
Communities to complete particular approval proced ures without undue delay did not itself impose, or 
lead to the imposition of, information requirements which were not necessary.  We therefore fail to 
see how the measures challenged by Argentina could be considered to give rise to an inconsistency 
with Annex C(1)(c).  At any rate, Argentina h as not identified specific information requirements 
which were imposed on applicants in the relevant  approval procedures, nor has it explained why any 
such requirements were not necessary fo r appropriate approval procedures.  
7.2483  Argentina also asserts that the European Co mmunities has breached its obligations under 
Annex C(1)(c) by requiring excessive submissions unde r the terms of subsequent legislation.  Here 
again, we must recall that the product-specific measures which Argentina is challenging are undue 
delays caused by the European Co mmunities in the consideration of particular applications.  The 
failure by the European Communities to complete pa rticular approval procedur es without undue delay 
did not impose a requirement on applicants to provi de information based on legislation not yet in 
force, nor did it cause such a requirement to be  imposed.  Likewise, the European Communities' 
failure to complete particular approval procedures without undue delay did not require applicants to 
update their applications in accordance with the provisions of Directive 2001/18 once that 
Directive had entered into force.  Nor did that  failure cause such a requirement to be imposed.
1667  We 
are therefore unable to agree with Argentina that the European Communities has breached its 
obligations under Annex C(1)(c) by requiring excessive submissions under the terms of subsequent 
legislation.  In any event, Argentina has not e xplained why the submissions it referred to were 
"excessive" and thus not necessary.   
7.2484  We note Argentina's argument that there were numerous requests for additional information 
in the approval procedures which are the subject of its  claims under Annex C(1)(c).  It is sufficient to 
note in this regard that if Argentina was of the vi ew that some or all of these requests for additional 
information constitute information requirements and that these requirements were not limited to what 
was necessary, it should have challenged these requests.    
7.2485  In the light of the above, we conclude that  Argentina has failed to establish its product-
specific claims under Annex C(1)(c).    
(b) Article 8 
7.2486  Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an 
inconsistency with Article 8 on the basis of an a lleged inconsistency with A nnex C(1)(c).  We have 
determined that Argentina has failed to establish its  claims under Annex C(1)(c).  Under the approach 
followed by Argentina, this means that its claims under Article 8 have not been established either.   
                                                      
1667 As pointed out by the European Communities, the requirement to up date applications in accordance 
with the provisions of Directive 2001/18 flows from Artic le 35 of that Directive.  Argentina does not challenge 
Article 35 as such.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 861 
  
  (c) Overall conclusion  
7.2487  In the light of the above, the Panel reaches the following conclusion:  
 (i) DS293 (Argentina) 
 
  With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the product-specific measures in respect of which the Panel is making findings have resulted in the Eur opean Communities acting inconsistently 
with its obligations under Annex C(1)(c) of the SPS Agreement  and, consequently, 
with its obligations under Article 8 of the SPS Agreement .   
 
13. Consistency of the product-specific measures with Article 8 and Annex C(1)(e) of the 
SPS Agreement  
7.2488  Argentina claims that the product-specific measure s identified by it are inconsistent with the 
European Communities' obligations under  Article 8 and Annex C(1)(e) of the SPS Agreement .    
7.2489  Article 8 of the SPS Agreement  provides: 
"Members shall observe the provisions of  Annex C in the operation of control, 
inspection and approval procedures, includi ng national systems for approving the use 
of additives or for establishing tolerances fo r contaminants in foods, beverages or 
feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the 
provisions of this Agreement." 
7.2490  Annex C(1)(e) of the SPS Agreement  provides: 
"Members shall ensure, with respect to any procedure to check and ensure the 
fulfilment of sanitary or phytosanitary measures, that:   
[...] 
(e) any requirements for control, in spection and approval of individual 
specimens of a product are limited to what is reasonable and necessary[.]"   
7.2491  Argentina  argues that the detailed requirements of  Directive 2001/18 and of its predecessor, 
Directive 90/220, as well as of Regulation 258/97 do not seem to meet the criteria of "reasonableness 
and necessity".  Moreover, the Eur opean Communities has failed to exercise the authority granted to it 
by the aforementioned legislation, and that failure to act cannot be deemed reasonable or necessary.  
Furthermore, when Directive 2001/18 came into force, no consideration was given to the newly 
submitted applications, nor were those applications  approved which had already been submitted under 
the predecessor Directive.  Argentina further s ubmits that the application of the European 
Communities' approval procedures is not limited to what is reasonable and necessary for the approval 
of biotech products.   
7.2492  The European Communities  argues that to the extent that Argentina's argument relates to 
the EC approval legislation itself, there is no reas on to respond as the legislation is not a measure at 
issue.  Furthermore, Argentina offers no support fo r its assertion that the application of the European 
Communities' approval procedures is not limited to what is reasonable and necessary for the approval WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 862 
  
  of biotech products.  The European Communities submits, therefore, that Argentina has not 
established a prima facie case.  
7.2493  The Panel  notes that Argentina relies on the allege d inconsistency of the relevant product-
specific measures with Annex C(1)(e) to make conseque ntial claims of inconsis tency under Article 8.  
Accordingly, we will begin our analysis with the claims under Annex C(1)(e).   
(a) Annex C(1)(e) 
7.2494  We note that Annex C(1)(e) imposes limita tions on any requirements for approval of 
"individual  specimens  of a product" (emphasis added).  The product-specific measures challenged by 
Argentina do not concern "individual specimens" of biotech products.  They concern specific biotech 
products for which marketing approval has been so ught.  We also recall that the product-specific 
measures which Argentina says give rise to an in consistency with Annex C(1)(e) are undue delays 
caused by the European Communities in the consider ation of particular applications.  It is not 
apparent to us that the European Communities' failure to complete approval procedures concerning 
particular biotech products without undue dela y imposed, or led to the imposition of, any 
requirements for the approval of individual specimens  of the relevant biotech products.  We therefore 
fail to see how the measures challenged by Argen tina could be considered to give rise to an 
inconsistency with Annex C(1)(e).   
7.2495  In the light of this, we conclude that Arge ntina has failed to establish its product-specific 
claims under Annex C(1)(e).   
7.2496  To the extent Argentina is seeking to challe nge requirements contained in the EC approval 
legislation, we agree with the European Communitie s that the relevant legislation is not a measure 
within our terms of reference. 
(b) Article 8 
7.2497  Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an 
inconsistency with Article 8 on the basis of an a lleged inconsistency with A nnex C(1)(e).  We have 
determined that Argentina has failed to establish its  claims under Annex C(1)(e).  Under the approach 
followed by Argentina, this means that its claims under Article 8 have not been established either.   
(c) Overall conclusion  
7.2498  In the light of the above, the Panel reaches the following conclusion:  
 (i) DS293 (Argentina) 
 
  With reference to DS293, and having rega rd to the arguments and evidence submitted 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the product-specific measures in respect of which the Panel is making findings have resulted in the Eur opean Communities acting inconsistently 
with its obligations under Annex C(1)(e) of the SPS Agreement  and, consequently, 
with its obligations under Article 8 of the SPS Agreement .   
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 863 
  
  14. Consistency of the product-specific measures with Article III:4 of the GATT 1994 
7.2499  Canada and Argentina claim that the European Communities has acted inconsistently with its 
obligations under Article III:4 of the GATT 1994 in r espect of the product-specific measures they are 
challenging.  We recall that the United States did not present claims under the GATT 1994.    
7.2500  Article III:4 of the GATT 1994 provides in relevant part: 
"The products of the territory of any contr acting party imported into the territory of 
any other contracting party shall be accord ed treatment no less favourable than that 
accorded to like products of national origin  in respect of all laws, regulations and 
requirements affecting their internal sale, offering for sale, purchase, transportation, 
distribution or use."   
7.2501  Canada  argues that the failure of the European Communities to consider or approve, without 
undue delay, the four applications of specific inter est to Canada falls within the scope of the GATT 
1994 and is inconsistent with the European Commun ities' obligations under Article III:4.  According 
to Canada, the measures at issue are "laws, re gulations or requirement s laws, regulations or 
requirements affecting the internal sale, offering for sale, purchase, and distribution" of the biotech 
products concerned; the biotech products subject  to the product-specific measures are "like" 
domestically-grown non-biotech counterparts in the li ght of the criteria put forth by the Appellate 
Body; and the imported biotech products concerned ar e accorded treatment less favourable than that 
accorded like non-biotech products of national origin .  Canada submits that, for these reasons, the 
measures at issue constitute a violation of the Eu ropean Communities' national treatment obligations 
under Article III:4.  
7.2502  Argentina  argues that the suspension of considera tion of, or the failure to consider, the 
particular applications of interest to Argentina is inconsistent with Ar ticle III:4 of the GATT 1994, 
because it gives less favourable treatment to biotech  products than to non-biotech products.  Argentina 
argues that the inconsistencies re sult from the fact that (i) biotech and non-biotech products are "like 
products", (ii) the suspension of consideration of, or the failure to consider, the particular applications 
are "requirements affecting the sale, offering sale, pur chase, transport, distribution and use of products 
on the domestic market", and (iii) the suspension of consideration of, or the failure to consider, the 
particular applications has modified the conditions of competition in the relevant market to the detriment of imported products. 
7.2503  The European Communities  argues that there is no violation of Article III:4 of the GATT 
1994 with regard to the product-specific measures ch allenged by Canada and Argentina.  This is 
because: (i) the measures challenged by Canada and Argentina are alleged delays in dealing with 
specific requests for approval within a specified timeframe, and these measures are not in themselves 
"laws, regulations or requirements" as provided fo r by Article III:4 of the GATT 1994; (ii) imported 
products are not accorded less favourable treatment  than like domestic products, as there is no 
discrimination between relevant imported biotech products and same  biotech products cultivated or 
processed domestically, which are the only "like products" to the imported biotech products 
concerned.  
7.2504  The 
Panel  will analyse Canada's and Argentina's claim separately. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 864 
  
  (a) DS292 (Canada) 
7.2505  In relation to DS292, we recall that we have al ready reached the conclusion that the failure by 
the European Communities to consider or appr ove, without undue delay, the four particular 
applications identified by Canada has given rise to  a breach of the European Communities' obligations 
under Annex C(1)(a), first clause, of the SPS Agreement  and, consequently, its obligations under 
Article 8 of the SPS Agreement .  In these circumstances, we see no need to examine, and offer 
additional findings on, whether the relevant measures are also inc onsistent with Article III:4.  
Accordingly, we exercise judicial economy with  regard to Canada's claim under Article III:4.
   
(b) DS293 (Argentina) 
7.2506  In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton 
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97. 
(i) Product-specific measures affecting the approval  of Bt-531 cotton and RR-1445 cotton under 
Regulation 258/97 
7.2507  Argentina challenges under Article III:4 the susp ension of consideration of, or failure to 
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted 
for "approval"1668 under Regulation 258/97.   
7.2508  We recall that in respect of the same allege d product-specific measures Argentina presented a 
claim under Article 5.1 of the SPS Agreement .  In the context of our analysis of that claim, we have 
pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445 
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina 
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or 
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97.  As the existence of these product-specifi c measures has not been demonstrated, we cannot but reject 
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under 
Article III:4 in relation to these alleged measures. 
(ii) Other product-specific measu res challenged by Argentina 
7.2509  We now turn to address the remaining eight pro duct-specific measures in respect of which the 
Panel has decided to make findings. 
7.2510  Argentina claims that the alleged suspension of c onsideration of, or the failure to consider, the 
relevant eight applications is inconsistent with Article III:4 of  the GATT 1994 because it resulted in 
less favourable treatment being accorded to the biot ech products which are the subject of the eight 
applications than to like non-biotech products. 
7.2511  Argentina submits that the alleged suspension of consideration of, or the failure to consider, 
an application for the approval of a biotech produc t constitutes a "requirement" affecting the sale, 
offering for sale, etc. within the meaning of Artic le III:4.  For the purposes of our analysis, we are 
willing to proceed on the assumption that the alleged suspension of consideration of, or the failure to 
consider, an application constitutes a "requirement" within the meaning of Article III:4.  Moreover, 
we initially focus our analysis on the "no less favourable treatment" obligation contained in Article III:4, rather than on the "like products" el ement.  We recall in this connection that the 
                                                     
 
1668 Argentina's first written submission, paras. 201-202.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 865 
  
  Appellate Body in EC – Asbestos  and Dominican Republic – Impor t and Sale of Cigarettes  made 
statements in relation to the meaning of the ph rase "no less favourable treatment" in Article III:4.
1669  
We find these statements to be relevant to th e type of measures challenged by Argentina under 
Article III:4. 
7.2512  Argentina contends that, as a result of the a lleged suspension of consideration of, or the 
failure to consider, the relevant eight applica tions, the European Comm unities has accorded "less 
favourable treatment" to the biotech products which ar e the subject of the eight applications than to 
like non-biotech products.  More particularly, Argen tina considers that the measures at issue have 
modified the conditions of competition in the EC market to the detriment of imported biotech 
products.  Argentina notes in this regard that as a result of the alleged suspension of consideration of, 
or the failure to consider, the relevant eight appli cations the biotech products which are the subject of 
these applications were not approved.  
7.2513  In considering Argentina's contention, the first thing to be observed is that Argentina has not 
provided specific factual information about the tr eatment accorded by the European Communities to 
the non-biotech products which Argentina considers to  be like the biotech products at issue.  It 
appears to be Argentina's contention, however, that these non-biotech products may be marketed in 
the European Communities, whereas the relevant  biotech products may not be marketed.  
7.2514  At any rate, even if it were the case that, as a result of the measures challenged by Argentina, 
the relevant imported biotech products cannot be marketed, while corresponding domestic non-
biotech products can be marketed , in accordance with the aforementioned statements by the Appellate 
Body this would not be sufficient, in and of itself, to raise a presumption that the European 
Communities accorded less favourable treatment to the group of like imported  products than to the 
group of like domestic  products.  We note that Argentina does not assert that domestic biotech 
products have not been less favourably treated in th e same way as imported biotech products, or that 
the like domestic non-biotech varietie s have been more favourably treated than the like imported non-
biotech varieties.  In other words, Argentina is not  alleging that the treatment of products has differed 
depending on their origin.  In these circumstances,  it is not self-evident that the alleged less 
favourable treatment of imported biotech products is explained by the foreign origin of these products 
rather than, for instance, a perceived difference be tween biotech products and non-biotech products in 
terms of their safety, etc.  In our view, Argentin a has not adduced argument and evidence sufficient to 
raise a presumption that the alleged less favourable treatment is explained by the foreign origin of the 
relevant biotech products. 
7.2515  In the light of the above, we find that Argentina has not established that, as a result of the 
alleged suspension of consideration of, or the failure  to consider, the relevant eight applications, the 
European Communities has accord ed "less favourable treatment" to imported products than to 
domestic products.    
7.2516  Since we have found that Argentina has not de monstrated to our satisfaction that imported 
products have been treated "less favourably" than domestic products, there is no need to go on to 
determine whether the challenged measures in fact constitute "requirements" within the meaning of 
Article III:4, and whether the imported products which Argentina alleges have been treated less 
favourably are "like" the domestic products whic h Argentina alleges have been treated more 
favourably.  Our finding on the "no less favourable treatment" obligation necessarily implies that 
Argentina has failed to establish its claim under Arti cle III:4 with regard to the eight product-specific 
measures in question.    
                                                      
1669 We have reproduced the relevant statements at paras. 7.2404 and 7.2405 above. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 866 
  
  (c) Conclusions 
7.2517  In the light of the above, the Panel reaches the following overall conclusions:  
 (i) DS292 (Canada) 
 
  With reference to DS292, and having re gard to the arguments and evidence presented 
by Canada and the European Communities,  the Panel concludes that it is not 
necessary to make findings on whether the product-specific measures which are being challenged by Canada are inconsistent  with Article III:4 of the GATT 1994.  
Accordingly, the Panel offers no findings under Article III:4. 
  (ii) DS293 (Argentina)    With reference to DS293, and having re gard to the arguments and evidence presented 
by Argentina and the European Communities,  the Panel concludes that Argentina has 
not established that the product-specific measures in respect of which the Panel is making findings have resulted in the Eur opean Communities acting inconsistently 
with its obligations under Ar ticle III:4 of the GATT 1994. 
 
15. Consistency of the product-specific measures with the TBT Agreement  
7.2518  The Panel now turns to address Canada's and Ar gentina's claims of inconsistency under the 
TBT Agreement .  We recall that the United States did not present claims under the TBT Agreement .   
7.2519  Canada considers that the product-specific measure s it is challenging are SPS measures and 
that, as such, they are not subject to the requirements of the TBT Agreement .  Canada argues, 
however, that if the Panel decides that the produc t-specific measures at issue are not SPS measures, 
then Canada submits, in the alternative, that th ese measures are subject to the requirements of the 
TBT Agreement .  More particularly, Canada's alternativ e claim is that the relevant measures are 
inconsistent with Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the TBT Agreement.  
7.2520  Furthermore, Canada states that to the extent that the Panel determines that parts of the 
measures at issue are covered by the TBT Agreement  in addition to the SPS Agreement , Canada's TBT 
claims are to be considered cumu lative rather than alternative, vis-à-vis  its SPS claims. 
7.2521  Argentina  considers that the Panel should examin e the product-specific measures Argentina 
is challenging under the SPS Agreement .  However, if the Panel concludes that it should not analize 
Argentina's claim under the SPS Agreement , Argentina submits, in the alternative, that the product-
specific measures at issue are subject to the requirements of the TBT Agreement .  More particularly, in 
Argentina's view the relevant measures are inconsistent with Articles 2.1, 2.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2 
and 12 of the TBT Agreement . 
7.2522  The European Communities  considers that, given the reas ons on which the relevant product-
specific measures are based, they fall in part within the scope of the SPS Agreement
 and in part 
outside the scope of the SPS Agreement .  However, the European Comm unities rejects the alternative 
claims by Canada and Argentina that the releva nt product-specific measures they are challenging are 
inconsistent with the TBT Agreement .   
7.2523  The Panel  will analyse Canada's and Argentina's claims separately.