WORLD TRADE  
ORGANIZATION  WT/DS291/R 
WT/DS292/R 
WT/DS293/R 
29 September 2006 
 (06-4318) 
 Original:   English 
  
 
     
EUROPEAN COMMUNITIES – MEASURES AFFECTING 
THE APPROVAL AND MARKETING 
OF BIOTECH PRODUCTS 
 
  
Reports of the Panel 
 
 
 
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
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  TABLE OF CONTENTS 
Page
 
 
TABLE OF CASES CITED IN THIS REPORT ...........................................................................XLI  
LIST OF ABBREVIATIONS .........................................................................................................X LV 
SHORT AND FULL TITLES OF PRODUCTS ....................................................................... XLVII  
I. INTRODUCTION ................................................................................................................... .1 
A. COMPLAINT OF THE UNITED STATES ..........................................................................................1  
B. COMPLAINT OF CANADA .............................................................................................................1  
C. COMPLAINT OF ARGENTINA ........................................................................................................1  
D. ESTABLISHMENT AND COMPOSITION OF THE PANEL ..................................................................2  
E. PANEL PROCEEDINGS ..................................................................................................................3  
II. FACTUAL ASPECTS ..............................................................................................................3  
III. COMPLAINING PARTIES' REQUESTS FOR FINDINGS AND 
RECOMMENDATIONS..........................................................................................................4  
A. UNITED STATES ...........................................................................................................................4  
B. CANADA ............................................................................................................................... .......4  
C. ARGENTINA ............................................................................................................................... ..5 
IV. ARGUMENTS OF THE PARTIES ........................................................................................5  
A. PRELIMINARY WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES .................................5  
1. Introduction................................................................................................................... ............5  
2. The Panel requests fail to identify the "specific meas ure at issue"......................................6  
(a) The "measures" as described  in the Requests .............................................................................6  
(b) Speaking of two distinct measures, suspen sion and failure to act, without describing 
them, the requests fail to identify the specific measur e at issue .................................................7  
3. The Panel requests do not provide a brief summary of the legal basis of the 
complaint sufficient to presen t the problem clearly...............................................................7  
(a) The mere listing of provisions is not sufficient in this case........................................................8  
(b) No link is made between the provisions listed and the facts of the case ....................................9  
4. Article 6.2 issues must be decided as early as possible in the proceedings ..........................9  
(a) The Panel has to be able to establis h the limits of its jurisdiction ............................................10  
(b) The European Communities has been unable to start preparing its defence in any 
meaningful way................................................................................................................. ........10  
(c) The Panel must scrutinize the request to ensure its compliance with Article 6.2.....................10  
(d) The Panel must scrutinize the request as early as possible in panel proceedings .....................11  
5. Request for preliminary ruling..............................................................................................11  
B. PRELIMINARY WRITTEN SUBMISSION OF THE UNITED STATES ................................................11  WT/DS291/R 
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  1.
 Introduction................................................................................................................... ..........11  
2. The requirements of Article 6.2 of the DSU .........................................................................12  
3. The European Communities' assertion that the US panel request does not 
identify the "specific measu res at issue" is incorrect ..........................................................13  
4. Contrary to the European Communities'  allegations, the US panel request 
provides a brief summary of the legal basi s of the complaint sufficient to present 
the problem clearly ............................................................................................................ .....14  
5. The US panel request does not prejudice the ability of the European 
Communities to defend itself..................................................................................................1 7 
6. The European Communities failed to raise it s Article 6.2 concerns at the earliest 
possible opportunity ........................................................................................................... ....17  
C. PRELIMINARY WRITTEN SUBMISSION OF CANADA ..................................................................18  
1. Introduction................................................................................................................... ..........18  
2. Requirements of Articl e 6.2 of the DSU................................................................................18  
3. Canada's Panel request identifies the "sp ecific measure at issue" as required by 
Article 6.2 of  the DSU ......................................................................................................... ....19  
(a) The moratorium is identified with sufficient precision.............................................................19  
4. Canada's panel request provides "a brief summary of the legal basis of the 
complaint sufficient to present the problem clearly" as required by Article 6.2 ..............20  
(a) In view of the circumstances surrounding th is case, Canada's listing of the relevant 
provisions complies with the requirements of Article 6.2 ........................................................20  
(b) Canada's panel request establishes an ade quate link between the provisions listed and 
the measures at issue, consis tent with Article 6.2.....................................................................21  
(c) Article 6.2 does not require a complaining party to include a summary of its legal 
argument in its request to establish a panel...............................................................................22  
5. Canada's panel request does not prejudice the ability of the European 
Communities to defend itself..................................................................................................2 2 
D. PRELIMINARY WRITTEN SUBMISSION OF ARGENTINA .............................................................23  
1. Introduction................................................................................................................... ..........23  
2. Object and purpose of Article 6.2..........................................................................................23  
3. The European Communities' claim regarding partial lack of identification of the 
measure at issue ............................................................................................................... .......24  
4. The alleged lack of brief summary of the legal basis ...........................................................26  
(a) Textual reading ................................................................................................................ .........26  
(b) Identification of the legal basis .............................................................................................. ...26 
(c) The issue of multiple obligations.............................................................................................. 26 
5. The lack of  prejudice .......................................................................................................... ....27  
E. FIRST WRITTEN SUBMISSION OF THE UNITED STATES .............................................................27   WT/DS291/R 
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  1.
 Introduction................................................................................................................... ..........27  
2. Statement of facts............................................................................................................. .......28  
(a) Biotechnology.................................................................................................................. .........28  
(b) Moratorium on approvals of biotech products..........................................................................30  
(c) Member States' marketing or import bans ................................................................................31  
3. Legal discussion............................................................................................................... ........32  
(a) General moratorium violates the SPS Agreement .....................................................................32  
(b) Product-specific moratoria  violate the SPS Agreement ............................................................37  
(c) EC member State marketing or import bans violate the SPS Agreement .................................37  
(d) Greek import ban violates Article XI........................................................................................38  
F. FIRST WRITTEN SUBMISSION OF CANADA ................................................................................38  
1. Introduction................................................................................................................... ..........38  
2. Scientific background .......................................................................................................... ...39 
3. EC Legislation and the moratorium .....................................................................................39  
(a) The approval legislation....................................................................................................... .....39  
(b) Moratorium on approvals of biotech products..........................................................................41  
4. The moratorium................................................................................................................. .....41  
(a) The moratorium violates the SPS Agreement ...........................................................................41  
(i) The moratorium violates Article 5.1 .........................................................................................41  
(ii) The moratorium violates Article 5.6 .........................................................................................42  
(iii) The moratorium violates Article 2.2 .........................................................................................42  
(iv) The moratorium violates Article 5.5 .........................................................................................42  
(v) The moratorium violates Article 2.3 .........................................................................................43  
(vi) The moratorium violates Article 8 and paragraph 1(a) of Annex C.........................................44  
(vii) The European Communities has violated Ar ticle 7 and Paragraph 1 of Annex B by 
failing to "publish promptly" the moratorium...........................................................................44  
5. The product-specific marketing bans ......................................................................................44  
(a) The product-specific marketing bans  violate the SPS Agreement ............................................44  
(b) The p roduct-specific marketing bans  violate Article III:4 of the GATT 1994.........................44  
(c) The p roduct-specific marketing bans  violate the TBT Agreement ............................................46  
6. The EC member State national measures ...............................................................................46  
(a) The EC member State national measures violate the SPS Agreement ......................................46  
(i) The EC member State national me asures violate Article 5.1....................................................46  
(ii) The EC member State national me asures violate Article 5.6....................................................47  
(iii) The EC member State national me asures violate Article 2.2....................................................47  WT/DS291/R 
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  (iv)
 The EC member State national me asures violate Article 5.5....................................................48  
(v) The EC member State national me asures violate Article 2.3....................................................49  
(b) The EC member State national measures violate GATT 1994.................................................49  
(i) Four EC member State national measures violate Article III:4 ...............................................49  
(ii) Greece's import ban on Topas 19/2 violates Article XI:1.........................................................50  
(c) The TBT Agreement  applies to the EC member State national measures .................................50  
G. FIRST WRITTEN SUBMISSION OF ARGENTINA ...........................................................................50  
1. Introduction................................................................................................................... ..........50  
2. Inconsistency with the SPS Agreement ..................................................................................51  
(a) Inconsistency of the de facto  moratorium with the SPS Agreement .........................................51  
(i) The de facto moratorium as a measure under the SPS Agreement...........................................51  
(ii) The de facto moratorium is inc onsistent with Article 5.1 .........................................................52  
(iii) The de facto moratorium is inc onsistent with Article 2.2 .........................................................52  
(iv) The de facto moratorium cannot be just ified under the exception provided for in 
Article 5.7.................................................................................................................... ..............52  
(v) The de facto moratorium is inc onsistent with Article 5.5 .........................................................53  
(vi) The de facto moratorium is inc onsistent with Article 2.3 .........................................................54  
(vii) The de facto moratorium is inconsiste nt with Article 7 and Annex B:1....................................54  
(viii) The de facto moratorium is inc onsistent with Article 10.1 .......................................................54  
(b) Inconsistency of the "suspe nsion of processing and failure to consider individual 
applications for approval of specific biot ech agricultural products of particular 
interest to Argentina" with the  SPS Agreement ........................................................................54  
(i) Suspension of the approval processes for biot ech agricultural products of particular 
interest to Argentina .......................................................................................................... .......54  
(ii) The suspension is inconsistent with Article 5.1.........................................................................55  
(iii) The suspension is inconsistent with Article 2.2.........................................................................55  
(iv) The suspension is inconsistent with Article 5.5.........................................................................55  
(v) The suspension is inconsistent with Article 5.6.........................................................................56  
(c) Inconsistency with the SPS Agreement  of the "undue delay" in the processing of 
individual applications for approval of biot ech agricultural products of particular 
interest to Argentina.......................................................................................................... ........56  
(i) Analysis in light of the provisions of Artic le 8 and paragraph 1(a), 1(b), 1(c) and 1(e) 
of Annex C..................................................................................................................... ............56  
3. Inconsistency with GATT 1994..............................................................................................57  
(a) Inconsistency with  Article III:4 ............................................................................................... .57 
(i) "Like products" within the fr amework of Article III:4..............................................................57   WT/DS291/R 
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  (ii)
 The suspension is a "requirement" affecti ng "the sale, offering for sale, purchase, 
transport, distribution and use of pr oducts on the domestic market".......................................58  
(iii) "Less favourable treatmen t" is accorded..................................................................................58  
4. Inconsistency with the TBT Agreement .................................................................................58  
(a) Alternative application of the TBT Agreement .........................................................................58  
(b) Inconsistency with the TBT Agreement of the application of the European 
Communities' legislation in relation to the a pproval of biotech agricultural products of 
particular interest to Argentina ............................................................................................... ..59 
(i) The European Communities' legislation c onstitutes "technical regulations" pursuant 
to paragraph 1 of Annex I...................................................................................................... ...59 
(ii) The procedures under the European Communiti es' legislation constitute conformity 
assessment pr ocedures.......................................................................................................... ....59  
(iii) The application of the European Communities' legislation is inconsistent with 
Article 2.1.................................................................................................................... ..............59  
(iv) The application of the European Communities' legislation is inconsistent with 
Article 2.2.................................................................................................................... ..............59  
(v) The application of the European Communities' legislation is inconsistent with 
Articles 5.1.1, 5.1.2, 5.2.1, 5.2.2. ........................................................................................... ...60 
(vi) Inconsistency of the application of th e European Communities' legislation with 
Article 12..................................................................................................................... ..............60  
5. Bans by various EC member States ......................................................................................60  
(a) The member State bans are inconsistent with the SPS Agreement ...........................................61  
(i) The EC member State bans as meas ures under the SPS Agreement.........................................61  
(ii) The member State bans are incons istent with Article 5.1 .........................................................61  
(iii) The member State bans are incons istent with Article 2.2 .........................................................61  
(iv) The member State bans are incons istent with Article 5.5 .........................................................61  
(v) The member State bans are incons istent with Article 2.3 .........................................................62  
(vi) The member State bans are incons istent with Article 5.6 .........................................................62  
(b) The member State bans are inc onsistent with the GATT 1994 ................................................62  
(i) Inconsistency w ith Article III:4............................................................................................... ..62 
(c) Inconsistency of the EC member State bans with the TBT Agreement .....................................63  
(i) The European Communities' legislation for approval of biotech agricultural products 
constitutes "technical regulations" pu rsuant to paragraph 1 of Annex 1.................................63  
(ii) The bans applied by some EC member States to specific biotech agricultural products 
of particular interest to Argentina a re inconsistent with Article 2.1 ........................................63  
(iii) The application of the European Communities' legislation is inconsistent with 
Article 2.2.................................................................................................................... ..............63  WT/DS291/R 
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  (iv)
 The bans imposed byEC member States on spec ific biotech agricultural products of 
particular interest to Argentina are in consistent with Ar ticle 2.9 of the 
TBT Agreement .................................................................................................................. .......63  
H. FIRST WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES .............................................64  
1. Introduction................................................................................................................... ..........64  
2. Factual part ................................................................................................................... ..........66  
(a) Scientific background .......................................................................................................... .....66  
(b) International and comparativ e regulatory arrangements...........................................................67  
(c) The European Communities ' regulatory framework.................................................................67  
(d) Individual product applications................................................................................................ .68 
3. Legal arguments................................................................................................................ ......69  
(a) Preliminary issues ............................................................................................................. ........69  
(b) The product-specific delays .................................................................................................... ..70 
(i) The measure.................................................................................................................... ..........70  
(ii) SPS Agreement.................................................................................................................. ........70  
(iii) GATT 1994 – Ar ticle III:4...................................................................................................... ...71 
(c) The "general suspension"....................................................................................................... ...72 
(i) The measure.................................................................................................................... ..........72  
(ii) There is no general suspension................................................................................................. 72 
(d) The EC member State safeguard measures...............................................................................72  
(i) SPS Agreement.................................................................................................................. ........72  
(ii) The GATT 1994.................................................................................................................. .......73  
(iii) The TBT Agreement .............................................................................................................. ....74  
(e) The special and differen tial treatment claims ...........................................................................74  
(f) Article XX of the GATT 1994..................................................................................................74  
4. Conclusion ..................................................................................................................... ..........75  
I. FIRST ORAL STATEMENT OF THE UNITED STATES ...................................................................75  
1. General comments on European Comm unities' first written submission .........................75  
2. General moratorium violates the SPS Agreement ................................................................76  
3. Product-specific moratoria violate the SPS Agreement .......................................................79  
4. Member State measures violate the SPS Agreement ............................................................79  
J. FIRST ORAL STATEMENT OF CANADA ......................................................................................81  
1. Introduction................................................................................................................... ..........81  
2. Issues relating to the moratorium .........................................................................................81  
(a) The European Communities maintains a moratorium ..............................................................81   WT/DS291/R 
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  (i)
 The moratorium is in effect.................................................................................................... ...81 
(ii) The European Communities denies the am ple evidence of the moratorium.............................82  
(b) The moratorium is a "measure" ................................................................................................82  
(c) The moratorium is an "SPS measure".......................................................................................83  
(d) The scope and application of the SPS Agreement .....................................................................83  
3. The product-specific marketing bans....................................................................................84  
4. EC member State national measures ....................................................................................84  
(a) Article 5.7 .................................................................................................................... .............84  
(b) Article 5.1 .................................................................................................................... .............86  
(c) Article 5.6 .................................................................................................................... .............86  
(d) Article 5.5 .................................................................................................................... .............86  
K. FIRST ORAL STATEMENT OF ARGENTINA .................................................................................87  
1. Introduction................................................................................................................... ..........87  
2. The de facto  moratorium is not based on scientific evidence and therefore 
infringes the SPS Agreement ..................................................................................................87  
(a) The measure at issue in these proceedings................................................................................87  
(b) Application of SPS Agreement  to the de facto  moratorium ......................................................89  
(c) Conclusions with respect to the de facto  moratorium...............................................................89  
3. The "suspension and failure to consider" is not based on scientific evidence and 
therefore violates WTO obligations ......................................................................................89  
4. The "undue delay".............................................................................................................. ....90  
5. The state bans are not based on scien tific evidence and therefore violate the 
SPS Agreement .........................................................................................................................91  
6. Article XX of the GATT 1994................................................................................................91  
7. Special and differential treatment.........................................................................................92  
(a) In the framework of the SPS Agreement ...................................................................................92  
(b) In the framework of the TBT Agreement ..................................................................................92  
(c) Conclusions regarding special and differen tial treatment for developing countries.................93  
8. Conclusion ..................................................................................................................... ..........93  
L. FIRST ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ...................................................93  
1. Introduction................................................................................................................... ..........93  
2. GMOs are still in their infancy ..............................................................................................93  
3. GMOs are characterised by  scientific complexity ...............................................................94  
4. GMOs raise the need for targeted regulatory approaches..................................................94  
5. The regulatory choices of the European Communities are those of a prudent, 
responsible government......................................................................................................... .95 WT/DS291/R 
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  6.
 The case of Bt 11 Maize........................................................................................................ ..95 
7. Legal issues ................................................................................................................... ...........96  
(a) Preliminary legal remarks...................................................................................................... ...96 
(b) The correct approach to interpretation......................................................................................96  
(c) The SPS Agreement  alone cannot dispose of all the issues linked to GMOs............................97  
(d) The issue of delay ............................................................................................................. ........97  
(e) Article 5.7 SPS Agreement ........................................................................................................97  
(f) The precautionary principle is a genera l principle of international law....................................97  
8. Conclusion ..................................................................................................................... ..........98  
M. SECOND WRITTEN SUBMISSION OF THE UNITED STATES .........................................................98  
1. Introduction................................................................................................................... ..........98  
2. The European Communities' statem ent of facts is misleading ...........................................99  
(a) The European Communities' st atement on the purported risks of biotech products is 
misleading..................................................................................................................... ............99  
(b) Neither the biosafety protocol nor the pr ecautionary approach serves as a defence to 
the European Communities in this dispute .............................................................................100  
(c) The European Communities' description of its biotech approval regime is inaccurate ..........101  
3. The SPS Agreement  applies to all measures in this dispute...............................................102  
4. General moratorium violates the SPS Agreement ..............................................................102  
5. Product-specific moratoria violate the SPS Agreement .....................................................104  
(a) Examples of applications which faced lengt hy delays, without any pending requests 
for information................................................................................................................ ........104  
(b) Product histories in which member St ates acknowledge oppos ition to approval 
regardless of the merits of the individual application .............................................................105  
(c) The European Communities' product histories are incomplete ..............................................107  
6. Member State measures violate the SPS Agreement ..........................................................108  
N. SECOND WRITTEN SUBMISSION OF CANADA ..........................................................................109  
1. Introduction................................................................................................................... ........109  
2. The moratorium................................................................................................................. ...110  
(a) The European Communities' as sertion that the moratorium does not exist is without 
merit.......................................................................................................................... ..............110  
(b) Rationalizations for the moratorium .......................................................................................111  
(c) The European Communities mischaracterizes ri sks associated with biotech products 
in comparison to non-biotech products with novel traits in an attempt to justify the 
moratorium..................................................................................................................... .........114  
3. Product specific marketing bans .........................................................................................115  
(a) Oilseed Rape Ms1xRF1 and Ms1xRf2 ...................................................................................115   WT/DS291/R 
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  (b)
 Oilseed Rape Ms8xRf3........................................................................................................... 115 
(c) Oilseed Rape GT73.............................................................................................................. ...116  
4. Mootness is no t relevant ....................................................................................................... 116 
5. The European Communities' appropriate level of protection ..........................................117  
6. EC member State national measur es ("safeguard measures") ........................................117  
(a) Article 5.7 of the SPS Agreement  does not apply ...................................................................117  
(b) Even if Article 5.7 were to apply to the EC member State national measures, it would 
not exclude the application of Articles 5.5 and/or 5.6 ............................................................118  
(c) The EC member State national measures are not based on a risk assessment, as required by Article 5.1 ........................................................................................................ ....119
 
(d) The EC member State national measures violate the TBT Agreement ....................................119  
(i) The EC member State national measures are "technical regulations"...................................120  
(ii) The measures violate Article 2.1.............................................................................................12 0 
(iii) The measures violate Article 2.2.............................................................................................12 0 
(iv) The measures violate Article 2.9.............................................................................................12 1 
O. SECOND WRITTEN SUBMISSION OF ARGENTINA ....................................................................121  
1. Arguments ...................................................................................................................... .......121  
(a) The de facto  moratorium.........................................................................................................121  
(i) Introduction – The existence of a de facto moratorium ..........................................................121  
(ii) The de facto moratorium measure ..........................................................................................122  
(iii) Not simply a delay – Disregard of scientific evidence............................................................123  
(iv) The European Communities implements and maintains a de facto moratorium ....................123  
a.-  The "Inter-Service Consultation"  phase .................................................................................... ...... 124  
b.-  The "Common Position" and the decl aration by various member States........................................ 124  
c.-  Regarding the "I nterim approach".......................................................................................... ......... 125  
d.-  Further applications receive positive scien tific opinions, before th e entry into force of 
Directive 2001/18.............................................................................................................. .................... 125  
e.-  Claims concerning the re view of Direc tive 90/2 20 ......................................................................... 1 26 
f.-  Entry into force of Directiv e 2001/18..................................................................................... ......... 126  
g.-  Regarding the traceability  and labelling legislation ...................................................................... .. 127 
h.-  Regarding the European Communities' arguments based on the Cartagena Protocol and the 
so-called "precauti onary principle" ............................................................................................ ........... 127  
(v) The de facto moratorium is inconsistent with Article 10.1 of the SPS Agreement..................128  
(b) The "suspension of processing and failure to  consider individual applications for 
specific products of particular interest to Argentina" .............................................................129  
(i) General comments ............................................................................................................... ...129  
(ii) Specific products.............................................................................................................. .......130  WT/DS291/R 
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  a.-  Bt 531 cotton and RRC 1445  cotton......................................................................................... ....... 130  
b.-  NK 603 maize .............................................................................................................. ................... 131  
c.-  GA 21 maize ............................................................................................................... .................... 132  
(c) "Undue delay".................................................................................................................. .......132  
(d) Bans by various member States ..............................................................................................133  
(i) Article 5.7 as a defence for measures that  would otherwise infringe Articles 2.2 and 
5.1 ............................................................................................................................ ...............134  
(ii) Article 5.7, Article 5. 5 and Article 5.6....................................................................................135  
(iii) Article 5.7.................................................................................................................... ............135  
(iv) No invocation regarding  the de facto mora torium or the "suspension of processing 
and failure to consider specific applications of  products of interest of Argentina" ...............135  
P. SECOND WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES .......................................136  
1. Horizontal issues .............................................................................................................. .....136  
(a) Burden of proof................................................................................................................ .......136  
(b) Risk assessment and the role of scientific opinions................................................................136  
(i) The meaning of "risk assessment" in the SPS Agreement.......................................................136  
(ii) Risk assessment and the role of scientific opinions ................................................................137  
(c) The SPS Agreement .................................................................................................................137  
(i) The scope of the SPS Agreement.............................................................................................137  
(ii) Mixed acts ..................................................................................................................... ..........138  
(iii) Article 2 and Article 5.7 of the SPS Agreement ......................................................................139  
(iv) Article 5.7 and the rest of Artic le 5 of the SPS Agreement .....................................................139  
(v) Article 5.7 of the SPS Agreement............................................................................................140  
(vi) Article 2.3 of the SPS Agreement............................................................................................140  
(d) The TBT Agreement ................................................................................................................140  
(i) The meaning of the term "technical regulation".....................................................................141  
(ii) Article 2.1 of the TBT Agreement  – the issue of likeness.......................................................141  
(iii) Article 2.2 of the TBT Agreement ...........................................................................................141  
(iv) Article 5 of the TBT Agreement – The meaning of "conformity assessment procedure"........141  
(e) GATT 1994...................................................................................................................... .......142  
(f) WTO and other international agreements ...............................................................................142  
(g) Mootness....................................................................................................................... ..........142  
2. Complaining parties' claims.................................................................................................142  
(a) Product-specifi c delays ........................................................................................................ ...142  
(i) Factual issues ................................................................................................................. ........143   WT/DS291/R 
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  The individual product-specific applications/no tificatio ns.................................................................... 1 43 
The time el ement............................................................................................................... .................... 143  
The scientific and technical nature of the reasons for the delays .......................................................... 144  
(ii) Legal issues................................................................................................................... ..........144  
Burden of  proof ................................................................................................................ ..................... 144  
Applicable  law................................................................................................................. ...................... 144  
The SPS Agreement ............................................................................................................................... 145 
The TBT Agreement .............................................................................................................................. 1 46 
GATT 1994 – Articles III:4 and XX .............................................................................................. ....... 146  
(b) The alleged "general suspension" or "general moratorium" ...................................................146  
(i) Measures at issue.............................................................................................................. ......146  
(ii) The issues the Panel would have to  address if there were a measure ....................................147  
(c) The EC member State safeguard measures.............................................................................147  
(i) Facts and legal argument before the Panel............................................................................147  
(ii) The concerns of the member States.........................................................................................147  
Q. THIRD WRITTEN SUBMISSION OF THE UNITED STATES ..........................................................148  
1. Introduction................................................................................................................... ........148  
2. The second written submission of the Eu ropean Communities fails to raise any 
meritorious ar guments .........................................................................................................1 48 
(a) The European Communities' concept of "mootn ess" is not relevant to this dispute...............148  
(b) The European Communities again fails to provide any argument rebutting the widely 
known fact that the European Communiti es has adopted a general moratorium....................149  
(c) The European Communities' theory of "mixed delays" is meritless.......................................151  
(d) The European Communities has no basis for its argument that the Panel should depart 
from the definition of "risk assessment" set out in the Agreement.........................................151  
(e) The European Communities continues not to present a serious defence of its member 
State measures................................................................................................................. ........152  
3. The European Communities cannot expl ain away the gaps in its product 
chronologies................................................................................................................... ........152  
(a) EC Exhibit 69:  Glufosinate tolerant  and insect resistant (Bt-11) corn...................................152  
(b) EC Exhibit 65:  Bt cotton (531) ..............................................................................................15 2 
(c) EC Exhibit 91:  Roundup Ready corn (GA21) .......................................................................153  
(d) EC Exhibits 78 and 85:  Roundup Ready corn (GA21)..........................................................153  
(e) EC Exhibits 82 and 94:  MaisGuard x Roundup Ready (MON810 x GA21) corn.................154  
(f) EC Exhibit 66:  Roundup Ready cotton (RRC1445) ..............................................................154  
(g) EC Exhibit 64:  Roundup Ready fodder beet (A5/15) ............................................................154  
(h) EC Exhibit 76 and 96:  Ro undup Ready corn (NK603)..........................................................155  WT/DS291/R 
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  (i)
 EC Exhibit 62:  Oilseed rape (FALCON GS40/90)................................................................155  
(j) EC Exhibit 92:  Bt-11 Sweet Corn..........................................................................................156  
4. Many member State requests for inform ation were not based on legitimate 
scientific concerns ............................................................................................................ .....156  
(a) Member State objections do not illustrate  scientific disagreement or uncertainty .................156  
(b) Various member State objections relate solely  to inappropriate "theoretical risks" ...............157  
(i) Requests for chronic toxicity tests, when acute studies show no effects .................................157  
(ii) Request for multiple whole food studies .................................................................................157  
(iii) Insistence that safety of hybrid products be proven independent of the data on the 
parent......................................................................................................................... .............158  
(iv) Vague requests for data on environmental effects ..................................................................158  
(v) Requests for studies on the composition of the food derived from the animal........................159  
(vi) Objections wholly without scientific merit..............................................................................159  
R. THIRD WRITTEN SUBMISSION OF CANADA .............................................................................159  
1. Introduction................................................................................................................... ........159  
2. Horizontal issues .............................................................................................................. .....160  
(a) Burden of proof................................................................................................................ .......160  
(b) The European Communities' mischaracter ization of Canada's arguments .............................160  
(c) Risk assessments and Community-level Scientific Committees ............................................160  
(d) Interpretive issues relating to the SPS Agreement ..................................................................161  
(i) The definition of sanitary and phytosanitary measures ..........................................................161  
(ii) Article 2 and Article 5.7 of the SPS Agreement ......................................................................162  
(iii) Article 5.7 and the rest of Article 5.........................................................................................1 63 
(iv) Article 5.1.................................................................................................................... ............163  
(v) Article 5.5.................................................................................................................... ............163  
(vi) Article 5.6.................................................................................................................... ............164  
(vii) Article 5.7.................................................................................................................... ............164  
(viii) Article 2.3.................................................................................................................... ............164  
(ix) Annex C(1)(a) .................................................................................................................. .......164  
(e) The TBT Agreement ................................................................................................................165  
(f) Interpretive issues relating to GATT 1994 .............................................................................166  
(g) "Mixed" acts................................................................................................................... .........166  
(h) "Mixed" delay .................................................................................................................. .......166  
(i) Mootness....................................................................................................................... ..........167  
3. Canada's claims................................................................................................................ .....167   WT/DS291/R 
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  (a)
 Moratorium ..................................................................................................................... ........167  
(b) The product-specific marketing bans......................................................................................168  
(i) Oilseed Rape Ms1xRf1 and MsxRf2........................................................................................168  
(ii) Oilseed Rape Ms8/Rf3........................................................................................................... ..168  
(iii) Oilseed Rape GT73.............................................................................................................. ...170  
(c) The EC member State national measures ...............................................................................170  
S. THIRD WRITTEN SUBMISSION OF ARGENTINA .......................................................................171  
1. Introduction................................................................................................................... ........171  
2. Arguments ...................................................................................................................... .......172  
(a) The de facto  moratorium.........................................................................................................172  
(i) The existence of a de facto moratorium..................................................................................172  
The "Inter-Service Co nsultation" phase ......................................................................................... ....... 172  
The "Common Position" and the declara tion by various me mber States .............................................. 173  
Regarding the "Int erim approach"............................................................................................... .......... 173  
Further applications receive po sitive scientific opinions befo re the entry into force of 
Directive 2001/18.............................................................................................................. .................... 173  
(ii) Conclusion ..................................................................................................................... .........174  
(b) The "suspension of processing and failure to  consider individual applications for 
specific products of particular interest to Argentina" .............................................................175  
(i) General comments ............................................................................................................... ...175  
(ii) Specific products.............................................................................................................. .......175  
Bt 531 cotton .................................................................................................................. ....................... 175  
The proceedings were stalled................................................................................................... ...... 175  
Comments on the information pr ovided on the CD ROMs ........................................................... 175  
RRC 1445 cotton................................................................................................................ ................... 176  
The proceedings were stalled................................................................................................... ...... 176  
Comments on the information pr ovided on the CD ROMs ........................................................... 176  
NK 603 maize................................................................................................................... ..................... 177  
The proceeding was sta lled..................................................................................................... ....... 177  
Comments on the information pr ovided on the CD ROMs ........................................................... 177  
GA 21 maize .................................................................................................................... ..................... 178  
The proceeding was sta lled..................................................................................................... ....... 178  
Comments on the information pr ovided on the CD ROMs ........................................................... 178  
(c) "Undue delay".................................................................................................................. .......178  
(d) TBT Agreement .......................................................................................................................179  
(i) Technical regulation ........................................................................................................... ....179  WT/DS291/R 
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  Article 2.1 of the TBT Agreement .......................................................................................................... 179  
Article 2.2 of the TBT Agreement .......................................................................................................... 179  
(ii) Conformity assessment procedure ..........................................................................................181  
Article 5.1.1 of the TBT Agreement ....................................................................................................... 181  
Article 5.1.2 of the TBT Agreement ....................................................................................................... 181  
Article 5.2.1 of the TBT Agreement ....................................................................................................... 181  
T. THIRD WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES ..........................................182  
1. Introduction................................................................................................................... ........182  
2. The burden of proof............................................................................................................ ..182  
3. The role of the Panel.......................................................................................................... ...184  
4. The function of expert advice...............................................................................................186  
5. Procedural fairness and the admission of additional questions........................................187  
U. SECOND ORAL STATEMENT OF THE UNITED STATES ON THE MEETING WITH EXPERTS 
AND ADDITIONAL SCIENTIFIC EVIDENCE ...............................................................................188  
1. Introduction................................................................................................................... ........188  
2. Evaluating whether particular questions were scientifically justified .............................189  
3. The European Communities' comments on the experts' responses .................................189  
4. Advice from IO's on definitions...........................................................................................192  
5. Experts' advice and safeguard measures............................................................................192  
V. SECOND ORAL STATEMENT OF CANADA ON THE MEETING WITH EXPERTS AND 
ADDITIONAL SCIENTIFIC EVIDENCE .......................................................................................192  
1. Comments on the meet ing with experts ..............................................................................192  
(a) Introduction................................................................................................................... ..........192  
(b) Herbicide Tolerant Crops....................................................................................................... .193 
(c) Seed Spillage.................................................................................................................. .........194  
(d) Molecular Char acterization..................................................................................................... 194 
(e) Biogeochemical Cycles.......................................................................................................... .194 
(f) Pest Status.................................................................................................................... ...........195  
(g) Scale-up Effects ............................................................................................................... .......195  
(h) Differences in Risks........................................................................................................... .....195  
(i) Conclusion ..................................................................................................................... .........195  
2. Comments on additional evidence submitted by other parties.........................................195  
W. SECOND ORAL STATEMENT OF ARGENTINA ON THE MEETING WITH EXPERTS AND 
ADDITIONAL SCIENTIFIC EVIDENCE .......................................................................................197  
1. Comments on the expert meeting (17-18 February) ..........................................................197  
(a) Mere information vs. scientific evidence................................................................................197   WT/DS291/R 
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  (i)
 The relevance of scientific evidence........................................................................................197  
(ii) Scientific evidence and hypothetical statements .....................................................................198  
(iii) The excuse of waiting for more information to appear...........................................................199  
(iv) The twisted view of the biotechnology – Relevance of science ...............................................199  
(b) Agricultural biotech products and "non-biotech" products.....................................................200  
2. Comments on "additional  scientific evidence" ..................................................................201  
X. SECOND ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ON THE MEETING 
WITH EXPERTS AND ADDITIONAL SCIENTIFIC EVIDENCE .......................................................201  
1. Comments on the meet ing with experts ..............................................................................201  
2. Comments on additional evidence submitted by other parties.........................................205  
Y. SECOND ORAL STATEMENT OF THE UNITED STATES ON THE EUROPEAN 
COMMUNITIES ' SECOND AND THIRD SUBMISSIONS ................................................................206  
1. Introduction................................................................................................................... ........206  
2. Developments since the first  substantive meeting..............................................................206  
3. Burden of proof................................................................................................................ .....208  
4. Member State safeguards.....................................................................................................209  
5. Mootness ....................................................................................................................... .........210  
Z. SECOND ORAL STATEMENT OF CANADA ON THE EUROPEAN COMMUNITIES ' SECOND 
AND THIRD SUBMISSIONS .......................................................................................................211  
1. Introduction................................................................................................................... ........211  
2. Overview of th e dispute........................................................................................................ 211 
3. Arguments and evidence relating to the moratorium  and the product-specific 
bans ........................................................................................................................... .............212  
(a) The moratorium ................................................................................................................. .....212  
(i) The European Communities has failed to ba se its moratorium on a risk assessment in 
violation of Article 5.1 ....................................................................................................... .....212  
(ii) The European Communities may not rely on scientific uncertainty to justify the 
moratorium under Article 5.7 .................................................................................................21 3 
(iii) The European Communities' application of its appropriate level of protection for 
biotech products results in discrimination or a disguised restriction on international 
trade, contrary to Article 5.5 of the SPS Agreement...............................................................215  
(b) Product-specific marketing bans.............................................................................................216  
(i) Oilseed rape GT73.............................................................................................................. ....216  
(ii) Oilseed rape  Ms8xRf3........................................................................................................... ..217  
(c) National bans .................................................................................................................. ........217  
4. Other issues ................................................................................................................... ........219  WT/DS291/R 
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  AA.
 SECOND ORAL STATEMENT OF ARGENTINA ON THE EUROPEAN COMMUNITIES ' 
SECOND AND THIRD SUBMISSIONS .........................................................................................220  
1. The de facto  moratorium measure.......................................................................................220  
(a) The measure addressed in these proceedings..........................................................................220  
(b) Inconsistency of the de facto  moratorium with Article 5.1 of the SPS Agreement .................221  
(c) The European Communities cannot justify the de facto  moratorium under Article 5.7 
of SPS Agreement ...................................................................................................................221  
(d) The de facto  moratorium infringes Article 5.5 of SPS Agreement .........................................221  
2. The "suspension and failure to consider" is not based on scientific evidence, and 
therefore violates WTO obligations ....................................................................................221  
3. The "undue delay".............................................................................................................. ..222  
4. The member State bans are not based on scientific evidence, and therefore 
violate the SPS Agreement ....................................................................................................222  
BB. SECOND ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ON THE COMPLAINING 
PARTIES ' SECOND AND THIRD SUBMISSIONS ..........................................................................222  
1. Delays ......................................................................................................................... ............222  
(a) Burden of proof................................................................................................................ .......223  
(b) Delays identified as "undue" by  the complaining parties .......................................................223  
(c) Assessment of delays under the different cl aims made by the complaining parties...............227  
2. Mootness ....................................................................................................................... .........228  
V. ARGUMENTS OF THE THIRD PARTIES ......................................................................228  
A. THIRD PARTY ORAL STATEMENT OF AUSTRALIA ..................................................................228  
1. Introduction................................................................................................................... ........228  
2. Australian interests........................................................................................................... ....229  
3. Third party participation rights ..........................................................................................230  
B. THIRD PARTY ORAL STATEMENT OF CHILE ...........................................................................230  
C. THIRD PARTY WRITTEN SUBMISSION OF CHINA ....................................................................232  
1. Introduction................................................................................................................... ........232  
2. China's view on Article 5.7 of the SPS Agreement .............................................................232  
3. Biotech products and non-biotech products are not "like products" under 
Article III: 4 of the GATT 1994...........................................................................................233  
D. THIRD PARTY ORAL STATEMENT OF CHINA ...........................................................................234  
E. THIRD PARTY WRITTEN SUBMISSION OF NEW ZEALAND .......................................................235  
1. Introduction................................................................................................................... ........235  
2. Legal arguments................................................................................................................ ....237  
(a) The moratorium and product-specific marke ting bans are "measures" for the purposes 
of the SPS Agreement ..............................................................................................................237   WT/DS291/R 
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  (b)
 Procedural requirements of the SPS Agreement .....................................................................238  
(i) Failure to "publish promptly".................................................................................................2 38 
(ii) Undue delay .................................................................................................................... ........238  
(c) Substantive requirements of the SPS Agreement ....................................................................238  
F. THIRD PARTY ORAL STATEMENT OF NEW ZEALAND .............................................................239  
G. THIRD PARTY WRITTEN SUBMISSION OF NORWAY ................................................................240  
1. Introduction................................................................................................................... ........240  
2. Factual background, with emphasis on consequences of use of antibiotic 
resistance marker genes (ARMGs)......................................................................................241  
(a) Overview....................................................................................................................... ..........241  
3. Legal discussion............................................................................................................... ......243  
(a) Overview....................................................................................................................... ..........243  
(b) The SPS Agreement  is not applicable to measures against ARMGs.......................................243  
(c) Alternative argument in respect of Article 5.7 of the SPS Agreement ....................................244  
(d) The TBT Agreement  is not applicable to measures against ARMGs. .....................................245  
(e) The GATT 1994.................................................................................................................. ....245  
4. Concluding remarks ............................................................................................................. 246 
H. THIRD PARTY ORAL STATEMENT OF NORWAY ......................................................................246  
1. Introduction................................................................................................................... ........246  
2. Application of the SPS Agreement .......................................................................................246  
3. Application of the GATT  1994 – Article III:4....................................................................247  
4. Application of the GATT 1994 – Article XX ......................................................................247  
VI. INTERIM REVIEW.............................................................................................................248  
A. BACKGROUND ....................................................................................................................2 48 
B. STRUCTURE ...................................................................................................................... ...248  
C. PARTIES'  REQUESTS  FOR  CHANGES  TO THE  INTERIM  REPORTS............................249  
1. Procedural and other general matters ................................................................................249  
2. Relevant EC approval procedures ......................................................................................249  
(a) Comments common to Canada and Argentina .......................................................................249  
(b) Comments by Canada ............................................................................................................. 250 
(c) Comments by the European Communities..............................................................................250  
3. General EC moratorium ......................................................................................................261  
(a) Comments common to the United Stat es, Canada and Argentina ..........................................261  
(b) Comments by Canada ............................................................................................................. 263 
(c) Comments by Argentina .........................................................................................................2 64 WT/DS291/R 
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  (d)
 Comments by the European Communities..............................................................................264  
4. Product-specific measures....................................................................................................27 6 
(a) Comments by Argentina .........................................................................................................2 76 
(b) Comments by the European Communities..............................................................................276  
5. EC member State safeguard measures ...............................................................................278  
(a) Comments common to Canada and Argentina .......................................................................278  
(b) Comments by Canada ............................................................................................................. 278 
6. Conclusions and recommendations .....................................................................................279  
D. OTHER  CHANGES  TO THE  INTERIM  REPORTS .............................................................279  
E. REQUEST  FOR  REDACTION  OF PORTIONS  DISCLOSING  STRICTLY  
CONFIDENTIAL  INFORMATION ......................................................................................279  
F. PUBLIC  DISCLOSURE  OF THE  PANEL'S  CONFIDENTIAL  INTERIM  REPORTS........280  
VII. FINDINGS....................................................................................................................... ......282  
A. PROCEDURAL AND OTHER GENERAL MATTERS .......................................................................283  
1. Multiple complaints ............................................................................................................ ..283  
2. Amicus curiae  briefs..............................................................................................................284  
3. Consultation of individual scientific experts and international organizations................285  
(a) Consultation of individual experts ..........................................................................................286  
(b) Consultation of interna tional organizations ............................................................................289  
4. Annexes available on-line only.............................................................................................289  
5. Challenges faced by the Panel in the conduct of the proceedings.....................................290  
6. Consistency of the Complaining Parties' panel requests with Article 6.2 of the 
DSU ............................................................................................................................ ............292  
7. Relevance of other rules of international law to the interpretation of the WTO 
agreements at issue in this dispute ......................................................................................328  
(a) Other applicable rules of international la w as an interpretative element to be taken 
into account together with the "context" (Article 31(3)(c) of the Vienna Convention 
on the Law of Treaties ) ...........................................................................................................328  
(i) General ........................................................................................................................ ...........332  
(ii) Convention on Biological Diversity and Biosafety Protocol ..................................................335  
(iii) Precautionary principle........................................................................................................ ..336  
(b) Other rules of international law as evidence of  the ordinary meaning of terms used in 
a treaty....................................................................................................................... ..............341  
B. OVERVIEW  OF MEASURES  AT ISSUE .............................................................................342  
C. RELEVANT  EC APPROVAL  PROCEDURES.....................................................................343  
1. Evolution of the EC regime for the approval of biotech products ...................................344   WT/DS291/R 
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  2.
 Description of the relevant EC approval procedures ........................................................345  
(a) Deliberate release into the environment of genetically modified organisms: Directives 
90/220 and 2001/18............................................................................................................. ....346  
(i) Submission of application by applicant ..................................................................................346  
(ii) Assessment by lead CA.......................................................................................................... ..346  
(iii) Circulation of lead CA assessment report to  other member States for comments..................347  
(iv) Community-level procedure in case of objections ..................................................................347  
(v) Member State consent to placing on the market .....................................................................348  
(vi) Transition from Directive 90/220 to Dir ective 2001/18: Pending applications .....................348  
(vii) Safeguard measures by individual member States..................................................................349  
(viii) Availability under EC and member State law of procedures for administrative and 
judicial review................................................................................................................ .........350  
(b) Novel foods and novel food ingr edients: Regulation 258/97..................................................350  
(i) Submission of application by applicant ..................................................................................351  
(ii) Assessment by lead CA.......................................................................................................... ..351  
(iii) Circulation of lead CA assessment report to  other member States for comments..................351  
(iv) Community procedure in case an additional a ssessment is required or an objection is 
raised ......................................................................................................................... .............352  
(v) Simplified Procedure ........................................................................................................... ...352  
(vi) Safeguard measures by individual member States..................................................................353  
(vii) Availability under EC and member State law of procedures for administrative and 
judicial review................................................................................................................ .........353  
(c) GM food and feed and traceability and labelling of GMOs and traceability of food 
and feed products produced fro m GMOs:  Regulation 1829/2003 and 
Regulation 1830/2003........................................................................................................... ..354  
3. Applicability of the SPS Agreement .....................................................................................354  
(a) Whether a law, or a requirement containe d therein, may be deemed to embody an 
SPS measure as well as a non-SPS measure...........................................................................356  
(b) Whether the EC approval procedures are SPS measures in terms of their purpose................361  
(i) Directives 90/220 and 2001/18...............................................................................................364  
Protection of the environment .................................................................................................. ............. 368  
Annex A(1)(a) to the SPS Agreement:   Protection of animal or plant life or health from risks 
arising from the entry, establishment or spread  of pests, diseases, disease-carrying organisms 
or disease-causing organisms ................................................................................................... ............. 372  
"animal or plant life or health"............................................................................................... ........ 372  
"risks arising from"........................................................................................................... ............. 373  
"entry, establishm ent or spread" ............................................................................................... ..... 374  
"pests"........................................................................................................................ .................... 376  WT/DS291/R 
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  "diseases, disease carrying organisms or disease-causing  organisms" .......................................... 388  
antibiotic resistan ce marker genes ............................................................................................. .... 389  
Preliminary conclusions concerning An nex A(1)(a)to the SPS Agreement .................................. 391  
Annex A(1)(b) to the SPS Agreement :  Protection of human or animal life or health from risks 
arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages 
or feedstuffs.................................................................................................................. ......................... 392  
"foods, beverages or feedstuffs" ............................................................................................... ..... 392  
"additives".................................................................................................................... .................. 393  
"contaminants"................................................................................................................. .............. 396  
"toxins" ....................................................................................................................... ................... 399  
allergens...................................................................................................................... ................... 401  
"disease-causin g organisms".................................................................................................... ...... 404  
Preliminary conclusions concerning Annex A(1)(b)to the SPS Agreement ................................... 405  
Annex A(1)(c) to the SPS Agreement :  protection of human life or health from risks arising 
from diseases carried by animals,  plants or products thereof, or  from the entry, establishment 
or spread or pests............................................................................................................. ...................... 405  
allergenic effects of GMOs unrela ted to consumpti on as food...................................................... 405  
possible health effects from increased he rbicide use associat ed with GMOs................................ 407  
Preliminary conclusions concerning Annex A(1)(c) to the SPS Agreement .................................. 408  
Annex A(1)(d) to the SPS Agreement :  Prevent or limit other damage within the territory of a 
Member from the entry, establis hment or spread of pests..................................................................... 409  
"other damage" ................................................................................................................. ............. 409  
Preliminary conclusions concerning Annex A(1)(d) to the SPS Agreement .................................. 414  
Labelling to indicate presence of GMOs......................................................................................... ...... 414  
Conclusions with respect to the purpose of Directives 90/220  and 2001/18......................................... 418  
(ii) Regulation 258/97.............................................................................................................. .....418  
"present a danger for the consumer"............................................................................................ .......... 420  
"mislead the consumer"......................................................................................................... ................ 421  
"nutritionally di sadvantageous"................................................................................................ ............. 422  
Conclusions with respect to the purpose of Regula tion 258/97............................................................. 423  
(c) Whether the EC approval procedures are SPS measures in terms of their form and by 
their nature ................................................................................................................... ...........423  
(i) Conclusion on whether the EC approval procedures are "SPS measures" ............................426  
(d) Whether the EC approval procedures ma y affect international trade .....................................426  
D. GENERAL EC MORATORIUM ...................................................................................................427  
1. Measure at issue ............................................................................................................... .....427  
2. Existence of a general moratorium on approvals ..............................................................431  
(a) Alleged manner of suspending approvals ...............................................................................432   WT/DS291/R 
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  (b)
 Intention to suspend approvals................................................................................................4 34 
(i) EC member States............................................................................................................... ....434  
(ii) Commission..................................................................................................................... ........440  
(c) Absence of approvals during the relevant time period ...........................................................442  
(d) Documents and statements referring to a "moratorium".........................................................448  
(i) Commission documents and statements  by individual Commissioners ..................................450  
(ii) Council documents.............................................................................................................. ....456  
(iii) European Parliament documents............................................................................................457  
(iv) Statements by member State officials......................................................................................459  
(v) EC statements at the WTO ......................................................................................................4 61 
(vi) General assessment............................................................................................................. ....461  
(vii) Official EC position ........................................................................................................... .....465  
(e) Facts and histories of individual approval procedures............................................................466  
(i) Deliberate Release – Applications submitted under Directive 90/220 and/or 
Directive 2001/18 .............................................................................................................. .....469  
Failure by the Commission to submit a draft measure to the Council................................................... 470  
Bt-531 Cotto n (EC-65) .......................................................................................................... ........ 470  
RR-1445 cotto n (EC-66)......................................................................................................... ....... 474  
MON809 mai ze (EC- 83) ........................................................................................................... .... 478  
Transgenic toma to (EC-84) ...................................................................................................... ..... 480  
Failure by the Commission to re-convene the Regulatory Committee for a vote on a draft 
measure ........................................................................................................................ ......................... 483  
Falcon oilseed rape (EC-62) .................................................................................................... ...... 483  
MS8/RF3 oilseed rape (EC-63) ................................................................................................... .. 486 
RR fodder beet  (EC-64)......................................................................................................... ........ 491  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 493  
Transgenic pot ato (E C-67)...................................................................................................... ....... 493  
Liberator oilsee d rape (EC-68) ................................................................................................. ..... 495  
Bt-11 maize (EC-69)............................................................................................................ .......... 497  
GA21 maize (EC-78)............................................................................................................. ........ 499  
GA21 maize (EC-85)............................................................................................................. ........ 502  
T25 x MON810 ma ize (EC- 86) ..................................................................................................... 505 
Transgenic red-hearte d chicory (EC-77)........................................................................................ 5 06 
Delays at member  State level ................................................................................................... ............. 511  
Bt-531 cotto n (EC-65) .......................................................................................................... ......... 511  
RR-1445 cotto n (EC-66)......................................................................................................... ....... 513  WT/DS291/R 
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  RR oilseed rape  (EC-79)........................................................................................................ ........ 514  
RR oilseed rape  (EC-70)........................................................................................................ ........ 515  
LL soybeans (EC-71)............................................................................................................ ......... 520  
LL soybeans (EC-81)............................................................................................................ ......... 522  
LL oilseed rape  (EC-72) ........................................................................................................ ........ 525  
BXN cotton (EC-73)............................................................................................................. ......... 527  
Bt-1507 maiz e (EC-74).......................................................................................................... ........ 530  
Bt-1507 maiz e (EC-75).......................................................................................................... ........ 534  
Bt-11 maize (EC-80)............................................................................................................ .......... 537  
NK603 maize (EC-76)............................................................................................................ ....... 539  
GA21 maize (EC-85)............................................................................................................. ........ 542  
MON810 x GA21 maize (EC-82).................................................................................................. 54 5 
High-oleic soyb eans (EC-87).................................................................................................... ..... 549  
RR sugar beet  (EC-88).......................................................................................................... ......... 551  
Transgenic green-hearte d chicory (E C-110) .................................................................................. 554  
Member State failure to give cons ent to placing on the market ............................................................ 555  
MS1/RF1 oilseed rape (EC-89) ................................................................................................... .. 556 
MS1/RF2 oilseed rape (EC-90) ................................................................................................... .. 556 
Delays due to changes in the legislativ e framework ............................................................................. 560 
(ii) Novel Foods – Applications s ubmitted under Regulation 258/97...........................................562  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 564  
GA21 maize (fo od) (EC- 91) ...................................................................................................... .... 565  
Bt-11 sweet maize (food) (EC-92)............................................................................................... .. 570 
Transgenic tomato (food) (EC-100).............................................................................................. .5 7 5 
Failure by the Scientific Committee on  Food  to complete  its review................................................... 577  
Transgenic red-hearted chic ory (food) (E C-97)............................................................................. 577  
Transgenic green-hearted ch icory (food) (EC-98)......................................................................... 577  
Delays at member  State level ................................................................................................... ............. 580  
GA21 maize (fo od) (EC- 91) ...................................................................................................... .... 580  
LL soybeans (fo od) (EC- 93)..................................................................................................... ..... 582  
MON810 x GA21 maize (food) (EC-94)....................................................................................... 585  
Bt-1507 maize (f ood) (E C-95)................................................................................................... .... 590  
NK603 maize (fo od) (EC- 96) ..................................................................................................... ... 592  
High-oleic soybean s (food) (EC-99)............................................................................................. .5 9 6 
T25 x MON810 maize (food) (EC- 101) ........................................................................................ 598  
RR sugar beet (f ood) (EC-102).................................................................................................. .... 600  
(iii) Conduct of Group of Five countries generally .......................................................................603   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page xxiii 
  
  Voting behaviour by Group of Five countries in  the Regulatory Commit tee or Council...................... 603  
Objections by Group of Five countries to favourable assessment s by lead CAs................................... 604  
(iv) Commission conduct  prior to the June 1999 declaration by the Group of Five 
countries...................................................................................................................... ............605  
(v) Concluding observations ........................................................................................................ 608 
(f) Overall conclusions............................................................................................................ .....611  
3. Whether the Panel may and should make  findings on the WTO-consistency of 
the general de facto  moratorium on approvals...................................................................617  
(a) Whether the moratorium on approvals  is a challengeable measure........................................617  
(b) Whether the Panel should decline to make findings on the WTO-consistency of the 
moratorium on approvals if subsequent to the establishment of the Panel the 
moratorium ceased to exist ..................................................................................................... 619 
4. Claims of inconsistency raised by the Complaining Parties..............................................624  
5. Consistency of the general de facto  moratorium on approvals with Article 5.1 of 
the SPS Agreement ................................................................................................................625  
(a) "Sanitary or phytosan itary measure".......................................................................................626  
(b) Nature of the general de facto  moratorium on approvals........................................................629  
(i) Was the decision to apply a general moratorium on approvals a decision to reject all 
applications or did it predetermine such rejections?..............................................................629  
(ii) Did the decision to apply a general mora torium on approvals impose an effective 
marketing ban? ................................................................................................................. ......630  
(iii) Did the decision to apply a general moratorium on approvals itself establish a 
procedure or amend the existi ng EC approval procedures? ..................................................636  
(iv) Conclusion ..................................................................................................................... .........639  
(c) Applicability of Article 5.1 to the European  Communities' decision to apply a general 
de facto  moratorium on approvals ..........................................................................................640  
(d) Conclusions.................................................................................................................... .........642  
6. Consistency of the general de facto  moratorium on approvals with Article 5.6 of 
the SPS Agreement ................................................................................................................642  
(a) Applicability of Article 5.6 to the European  Communities' decision to apply a general 
de facto  moratorium on approvals ..........................................................................................644  
(b) Conclusions.................................................................................................................... .........644  
7. Consistency of the general de facto  moratorium on approvals with Article 5.5 of 
the SPS Agreement ................................................................................................................645  
(a) Applicability of Article 5.5 to the European  Communities' decision to apply a general 
de facto  moratorium on approvals ..........................................................................................646  
(b) Conclusions.................................................................................................................... .........647  
8. Consistency of the general de facto  moratorium on approvals with Article 2.2 of 
the SPS Agreement ................................................................................................................648  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxiv 
  
  (a)
 First requirement in Article 2.2............................................................................................... 649 
(b) Second and third requirements in Article 2.2 .........................................................................650  
(c) Conclusions.................................................................................................................... .........652  
9. Consistency of the general de facto  moratorium on approvals with Article 2.3 of 
the SPS Agreement ................................................................................................................652  
(a) Evaluation ..................................................................................................................... ..........653  
(b) Conclusions.................................................................................................................... .........653  
10. Consistency of the general de facto  moratorium on approvals with Article 7 and 
Annex B(1) of the SPS Agreement ........................................................................................654  
(a) "Sanitary and phytosanitary regulations"................................................................................655  
(b) Conclusions.................................................................................................................... .........657  
11. Consistency of the general de facto  moratorium on approvals with Article 8 and 
Annex C(1)(a), first clause, of the SPS Agreement .............................................................658  
(a) Annex C(1)(a), first clause.................................................................................................... ..663  
(i) Interpretation ................................................................................................................. .........663  
(ii) Application.................................................................................................................... ..........666  
Reason for general EC moratorium as a justificati on for delay............................................................. 667  
Perceived inadequacy of EC approval legislation in force between June 1999 to August 
2003 ........................................................................................................................... .................... 668  
Evolving science and application of a prudent and precautio nary approach ................................. 670  
Conclusion ..................................................................................................................... ................ 672  
Approval procedure concerning  MS8/RF3 oils eed rape........................................................................ 673  
Relationship of the approval procedure conducted under Directive 90/220 and that 
conducted under Di rective 2001/18.............................................................................................. .6 7 3 
Adoption of Directive 2001/18 as a justifi cation for delay............................................................ 674  
Examination of the approval procedure concerning MS8/RF3 oilseed rape.................................. 675  
Conclusions .................................................................................................................... ............... 680  
(b) Article 8 ...................................................................................................................... ............681  
(c) Overall conclusions............................................................................................................ .....681  
12. Consistency of the general de facto  moratorium on approvals with Article 8 and 
Annex C(1)(b) of the SPS Agreement ...................................................................................682  
(a) First obligation in Annex C(1)(b) (publ ication or communication of processing 
period)........................................................................................................................ .............684  
(b) Second obligation in Annex C(1)(b) (completeness of documentation).................................685  
(c) Third obligation in Annex C(1)(b) (transmission of results) ..................................................685  
(d) Fourth obligation in Annex C(1)(b) (p rocessing of deficient applications)............................685  
(e) Fifth obligation in Annex C(1)(b) (explanation of delay).......................................................686   WT/DS291/R 
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 Page xxv 
  
  (f)
 Article 8 ...................................................................................................................... ............686  
(g) Overall conclusion ............................................................................................................. .....686  
13. Consistency of the general de facto  moratorium on approvals with Article 10.1 of 
the SPS Agreement ................................................................................................................687  
(a) Argentina's claim .............................................................................................................. ......688  
(b) General de facto  moratorium on approvals as "SPS measure" ...............................................689  
(c) EC approval legislation as "SPS measure" .............................................................................690  
(d) Overall conclusion ............................................................................................................. .....692  
E. PRODUCT -SPECIFIC MEASURES ................................................................................................692  
1. Measures at  issue .............................................................................................................. ....692  
(a) General........................................................................................................................ ............692  
(b) Relevant applications.......................................................................................................... ....694  
(i) DS291 (United States).......................................................................................................... ...694  
(ii) DS292 (Canada) ................................................................................................................. ....695  
(iii) DS293 (Argentina).............................................................................................................. ....696  
(c) Withdrawn and approved applications....................................................................................697  
(i) Applications withdrawn before th e establishment of the Panel..............................................697  
(ii) Applications withdrawn after th e establishment of the Panel.................................................698  
(iii) Applications approved after the establishment of the Panel...................................................701  
(iv) Conclusion ..................................................................................................................... .........702  
2. Claims of inconsistency raised by the Complaining Parties..............................................702  
3. Consistency of the product-specific measures with Article 5.1 of the 
SPS Agreement .......................................................................................................................704  
(a) DS291 (United States) .......................................................................................................... ..706  
(b) DS292 (Canada)................................................................................................................. .....708  
(c) DS293 (Argentina).............................................................................................................. ....709  
(i) Product-specific measures affecting th e approval of Bt-531 cotton and RR-1445 
cotton under Regulation 258/97..............................................................................................709  
(ii) Other product-specific measures challenged by Argentina....................................................709  
(d) Conclusions.................................................................................................................... .........710  
4. Consistency of the product-specific measures with Article 5.6 of the 
SPS Agreement .......................................................................................................................710  
(a) DS292 (Canada)................................................................................................................. .....711  
(b) DS293 (Argentina).............................................................................................................. ....712  
(i) Product-specific measures affecting th e approval of Bt-531 cotton and RR-1445 
cotton under Regulation 258/97..............................................................................................712  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxvi 
  
  (ii)
 Other product-specific measures challenged by Argentina....................................................712  
(c) Conclusions.................................................................................................................... .........713  
5. Consistency of the product-specific measures with Article 5.5 of the 
SPS Agreement .......................................................................................................................713  
(a) DS291 (United States) .......................................................................................................... ..714  
(b) DS292 (Canada)................................................................................................................. .....715  
(c) DS293 (Argentina).............................................................................................................. ....715  
(i) Product-specific measures affecting th e approval of Bt-531 cotton and RR-1445 
cotton under Regulation 258/97..............................................................................................715  
(ii) Other product-specific measures challenged by Argentina....................................................716  
(d) Conclusions.................................................................................................................... .........716  
6. Consistency of the product-specific measures with Article 2.2 of the 
SPS Agreement .......................................................................................................................717  
(a) Evaluation ..................................................................................................................... ..........718  
(b) Conclusions.................................................................................................................... .........718  
7. Consistency of the product-specific measures with Article 2.3 of the 
SPS Agreement .......................................................................................................................719  
(a) DS292 (Canada)................................................................................................................. .....719  
(b) Conclusion ..................................................................................................................... .........720  
8. Consistency of the product-specific meas ures with Article 7 and Annex B(1) of 
the SPS Agreement ................................................................................................................720  
(a) "Sanitary and phytosanitary regulations"................................................................................721  
(b) Conclusion ..................................................................................................................... .........722  
9. Consistency of the product-specific meas ures with Article 8 and Annex C(1)(a), 
first clause, of the SPS Agreement .......................................................................................722  
(a) General........................................................................................................................ ............722  
(b) Deliberate Release – Applications subm itted under Directive 90/220 and/or 
Directive 2001/18 .............................................................................................................. .....723  
(i) Application of Annex C(1)(a), first cl ause, to approval procedures begun under 
Directives 90/220 and continued under 2001/18....................................................................723  
(ii) Falcon oilseed rape (EC-62) ..................................................................................................72 4 
Failure by the Commission to re-convene the Regulatory Committee for a vote on a draft 
measure ........................................................................................................................ ......................... 725  
Conclusion..................................................................................................................... ........................ 728  
(iii) MS8/RF3 oilseed rape (EC-63) ..............................................................................................729  
Failure by the Commission to re-convene the Regulatory Committee for a vote on a draft 
measure ........................................................................................................................ ......................... 730  
Conclusion..................................................................................................................... ........................ 734   WT/DS291/R 
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 Page xxvii 
  
  (iv)
 RR fodder beet (EC-64) ......................................................................................................... .734 
Failure by the Commission to re-convene the Regulatory Committee for a vote on a draft 
measure ........................................................................................................................ ......................... 735  
Conclusion..................................................................................................................... ........................ 737  
(v) Bt-531 cotton (EC-65).......................................................................................................... ...737  
Failure by the Commission to submit a draft measure to the Council................................................... 740  
Conclusions.................................................................................................................... ....................... 744  
(vi) RR-1445 Cotton (EC-66) ........................................................................................................7 44 
Failure by the Commission to submit a draft measure to the Council................................................... 747  
Conclusions.................................................................................................................... ....................... 750  
(vii) Transgenic potato (EC-67) .....................................................................................................7 51 
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 751  
Total amount of time taken since submission of application................................................................. 753  
Conclusion..................................................................................................................... ........................ 754  
(viii) Liberator oilseed rape (EC-68) ..............................................................................................755  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 755  
Conclusion..................................................................................................................... ........................ 757  
(ix) Bt-11 maize (EC-69) ............................................................................................................ ...757  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 758  
Conclusion..................................................................................................................... ........................ 760  
(x) RR oilseed rape (EC-70)........................................................................................................ .761 
Delay at member  State level.................................................................................................... .............. 763  
Conclusions.................................................................................................................... ....................... 767  
(xi) LL soybeans (EC-71) ............................................................................................................ ..768  
Delay at member  State level.................................................................................................... .............. 769  
Total amount of time taken since submission of application................................................................. 771  
Conclusions.................................................................................................................... ....................... 772  
(xii) LL oilseed rape (EC-72) ........................................................................................................ .773 
Delay at member  State level.................................................................................................... .............. 774  
Total amount of time taken since submission of application................................................................. 776  
Conclusions.................................................................................................................... ....................... 777  
(xiii) BXN cotton (EC-73)............................................................................................................. ...777  
Delay at member  State level.................................................................................................... .............. 778  
Conclusions.................................................................................................................... ....................... 781  
(xiv) Bt-1507 maize (EC-74) .......................................................................................................... .781 
Delay at member  State level.................................................................................................... .............. 782  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxviii 
  
  Conclusion..................................................................................................................... ........................ 784  
(xv) Bt-1507 maize (EC-75) .......................................................................................................... .785 
Delay at member  State level.................................................................................................... .............. 786  
Conclusion..................................................................................................................... ........................ 787  
(xvi) NK603 maize (EC-76)............................................................................................................ .788 
Delay at the memb er State level................................................................................................ ............ 789  
Conclusions.................................................................................................................... ....................... 791  
(xvii)  GA21 maize (EC-78)............................................................................................................. ..792  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 793  
Conclusions.................................................................................................................... ....................... 795  
(xviii)  MON810 x GA21 maize (EC-82) ............................................................................................796  
Delay at member  State level.................................................................................................... .............. 797  
Conclusion..................................................................................................................... ........................ 800  
(xix) RR sugar beet (EC-88).......................................................................................................... ..800  
Delay at member  State level.................................................................................................... .............. 800  
Conclusion..................................................................................................................... ........................ 803  
(xx) MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape (EC-90).....................................803  
Member State failure to give cons ent to placing on the market ............................................................ 805  
Conclusions.................................................................................................................... ....................... 808  
(c) Novel Foods – Applications subm itted under Regulation 258/97 ..........................................808  
(i) Application of Annex C(1)(a), first clau se, to approval procedures conducted under 
Regulation 258/97.............................................................................................................. .....809  
(ii) GA21 maize (food) (EC-91)....................................................................................................81 0 
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 813  
Conclusions.................................................................................................................... ....................... 816  
(iii) Bt-11 sweet maize (food) (EC-92)...........................................................................................816  
Failure by the Commission to submit a draft measure to the Regul atory Commi ttee ........................... 819  
Conclusion..................................................................................................................... ........................ 821  
(iv) LL soybeans (food) (EC-93)....................................................................................................8 22 
Delay at member  State level.................................................................................................... .............. 823  
Total amount of time taken since submission of application................................................................. 825  
Conclusions.................................................................................................................... ....................... 826  
(v) MON810 x GA21 maize (food) (EC-94) .................................................................................826  
Delay at member  State level.................................................................................................... .............. 829  
Conclusion..................................................................................................................... ........................ 831  
(vi) Bt-1507 maize (food) (EC-95) ................................................................................................832   WT/DS291/R 
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 Page xxix 
  
  Delay at member  State level.................................................................................................... .............. 833  
Conclusion..................................................................................................................... ........................ 834  
(vii) NK603 maize (food) (EC-96)..................................................................................................835  
Delay at member  State level.................................................................................................... .............. 836  
Conclusions.................................................................................................................... ....................... 838  
(viii) RR sugar beet (food) (EC-102)...............................................................................................839  
Delay at member  State level.................................................................................................... .............. 839  
Conclusion..................................................................................................................... ........................ 842  
(d) Summary of the Panel's conclusions.......................................................................................842  
10. Consistency of the product-specific meas ures with Article 8 and Annex C(1)(a), 
second clause, of the SPS Agreement ...................................................................................843  
(a) Annex C(1)(a), second clause .................................................................................................84 4 
(b) Article 8 ...................................................................................................................... ............849  
(c) Overall conclusion ............................................................................................................. .....849  
11. Consistency of the product-specific measures with Article 8 and Annex C(1)(b) 
of the SPS Agreement ............................................................................................................849  
(a) First obligation in Annex C(1)(b) (publ ication or communication of processing 
period)........................................................................................................................ .............852  
(b) Second obligation in Annex C(1)(b) (completeness of documentation).................................853  
(c) Third obligation in Annex C(1)(b) (transmission of results) ..................................................855  
(d) Fourth obligation in Annex C(1)(b) (p rocessing of deficient applications)............................857  
(e) Fifth obligation in Annex C(1)(b) (explanation of delay).......................................................857  
(f) Article 8 ...................................................................................................................... ............858  
(g) Overall conclusions............................................................................................................ .....858  
12. Consistency of the product-specific measu res with Article 8 and Annex C(1)(c) of 
the SPS Agreement ................................................................................................................858  
(a) Annex C(1)(c) .................................................................................................................. .......860  
(b) Article 8 ...................................................................................................................... ............860  
(c) Overall conclusion ............................................................................................................. .....861  
13. Consistency of the product-specific measu res with Article 8 and Annex C(1)(e) of 
the SPS Agreement ................................................................................................................861  
(a) Annex C(1)(e) .................................................................................................................. .......862  
(b) Article 8 ...................................................................................................................... ............862  
(c) Overall conclusion ............................................................................................................. .....862  
14. Consistency of the product-specific measures with Article III:4 of the GATT 
1994 ........................................................................................................................... .............863  
(a) DS292 (Canada)................................................................................................................. .....864  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxx 
  
  (b)
 DS293 (Argentina).............................................................................................................. ....864  
(i) Product-specific measures affecting th e approval of Bt-531 cotton and RR-1445 
cotton under Regulation 258/97..............................................................................................864  
(ii) Other product-specific measures challenged by Argentina....................................................864  
(c) Conclusions.................................................................................................................... .........866  
15. Consistency of the product-specific measures with the TBT Agreement ..........................866  
(a) DS292 (Canada)................................................................................................................. .....867  
(b) DS293 (Argentina).............................................................................................................. ....867  
(c) Conclusions.................................................................................................................... .........868  
F. EC MEMBER  STATE  SAFEGUARD  MEASURES .............................................................868  
1. Introduction................................................................................................................... ........868  
(a) Safeguard measures in the context of th e relevant EC approval procedures ..........................868  
(b) Overview of the specifi c measures at issue ............................................................................870  
(c) Overview of Parties' clai ms and Panel's approach..................................................................871  
2. Analysis of the safeguard measures in the light of the SPS Agreement ............................872  
(a) Applicability of the SPS Agreement ........................................................................................872  
(i) General ........................................................................................................................ ...........872  
(ii) Austria – T25 maize ............................................................................................................ ....876  
Is the Austrian safeguard measure on T25 maize an SPS measure?...................................................... 876  
Purpose of the safeguard measure............................................................................................... ... 876  
Form and nature of the safeguard measure .................................................................................... 881  
Conclusion ..................................................................................................................... ................ 882  
Effect on intern ational trade.................................................................................................. ................ 883  
Overall co nclusions............................................................................................................ ................... 883  
(iii) Austria – Bt-176 maize......................................................................................................... ...884  
Is the Austrian safeguard measure on  Bt-176 maize an SPS measure?................................................. 884  
Purpose of the safeguard measure............................................................................................... ... 884  
Form and nature of the measure................................................................................................. .... 892  
Conclusion ..................................................................................................................... ................ 892  
Effect on intern ational trade.................................................................................................. ................ 892  
Overall co nclusions............................................................................................................ ................... 893  
(iv) Austria – MON810 maize........................................................................................................8 93 
Is the Austrian safeguard measure on  MON810 maize an SPS measure?............................................. 893  
Purpose of the safeguard measure............................................................................................... ... 894  
Form and nature of the measure................................................................................................. .... 898  
Conclusion ..................................................................................................................... ................ 898   WT/DS291/R 
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 Page xxxi 
  
  Effect on intern ational trade.................................................................................................. ................ 899  
Overall co nclusions............................................................................................................ ................... 899  
(v) France – MS1/RF1 oilseed  rape (EC-161).............................................................................900  
Is the French safeguard measure on MS1/RF1 oilseed rape (EC-161) an SPS measure? ..................... 900  
Purpose of the safeguard measure............................................................................................... ... 900  
Form and nature of the measure................................................................................................. .... 906  
Conclusion ..................................................................................................................... ................ 907  
Effect on intern ational trade.................................................................................................. ................ 907  
Overall co nclusions............................................................................................................ ................... 908  
(vi) France – Topas oilseed rape...................................................................................................9 08 
Is the French safeguard measure on To pas oilseed rape an SPS measure? ........................................... 908  
Purpose of the safeguard measure............................................................................................... ... 909  
Form and nature of the measure................................................................................................. .... 911  
Conclusion ..................................................................................................................... ................ 911  
Effect on intern ational trade.................................................................................................. ................ 911  
Overall co nclusions............................................................................................................ ................... 912  
(vii) Germany – Bt-176 maize ........................................................................................................9 12 
Is the German safeguard measure on Bt-176 maize an SPS measure?.................................................. 913  
Purpose of the safeguard measure............................................................................................... ... 913  
Form and nature of the measure................................................................................................. .... 916  
Conclusion ..................................................................................................................... ................ 917  
Effect on intern ational trade.................................................................................................. ................ 918  
Overall co nclusions............................................................................................................ ................... 918  
(viii) Greece – Topas oilseed rape...................................................................................................9 19 
Is the Greek safeguard measure on Topa s oilseed rape an SPS measure?............................................. 919  
Purpose of the safeguard measure............................................................................................... ... 919  
Form and nature of the measure................................................................................................. .... 923  
Conclusion ..................................................................................................................... ................ 924  
Effect on intern ational trade.................................................................................................. ................ 924  
Overall co nclusions............................................................................................................ ................... 925  
(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163) .........................925  
Is the Italian safeguard measure on T25 maize, MON810 maize, MON809 maize and 
Bt-11 maize (EC-163)  an SPS measure?........................................................................................... .... 926  
Purpose of the safeguard measure............................................................................................... ... 926  
Form and nature of the measure................................................................................................. .... 929  
Conclusion ..................................................................................................................... ................ 930  
Effect on intern ational trade.................................................................................................. ................ 931  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxxii 
  
  Overall co nclusions............................................................................................................ ................... 931  
(x) Luxembourg – Bt-176 maize ...................................................................................................932  
Is the Luxembourg safeguard measure on Bt-176 maize an  SPS measure? .......................................... 932  
Purpose of the safeguard measure............................................................................................... ... 932  
Form and nature of the measure................................................................................................. .... 935  
Conclusion ..................................................................................................................... ................ 935  
Effect on intern ational trade.................................................................................................. ................ 936  
Overall co nclusions............................................................................................................ ................... 936  
(b) Preliminary issue:  The relationship betw een Article 5.1 and Article 5.7 of the 
SPS Agreement ........................................................................................................................937  
(i) "Provisionally adopted" SPS measures ..................................................................................937  
(ii) Article 5.7 of the SPS Agreement – right or exception from the "general obligation" 
under Article 5.1? ............................................................................................................. ......943  
Relationship between Article  2.2 and Article 5.7............................................................................... ... 945  
Relationship between Article  5.1 and Article 5.7............................................................................... ... 952  
(iii) Conclusion ..................................................................................................................... .........956  
(c) Consistency with Article 5.1 of the SPS Agreement  (initial assessment) ...............................957  
(i) General ........................................................................................................................ ...........958  
(ii) Austria – T25 maize ............................................................................................................ ....964  
"Risk asse ssment".............................................................................................................. .................... 964  
"Based on"..................................................................................................................... ........................ 969  
Overall co nclusions............................................................................................................ ................... 972  
(iii) Austria – Bt-176 maize......................................................................................................... ...973  
"Risk asse ssment".............................................................................................................. .................... 973  
"Based on"..................................................................................................................... ........................ 976  
Overall co nclusions............................................................................................................ ................... 977  
(iv) Austria – MON810 maize........................................................................................................9 77 
"Risk asse ssment".............................................................................................................. .................... 977  
"Based on"..................................................................................................................... ........................ 981  
Overall co nclusions............................................................................................................ ................... 982  
(v) France – MS1/RF1 oilseed  rape (EC-161).............................................................................982  
"Risk asse ssment".............................................................................................................. .................... 982  
"Based on"..................................................................................................................... ........................ 986  
Overall co nclusions............................................................................................................ ................... 987  
(vi) France – Topas oilseed rape...................................................................................................9 87 
"Risk asse ssment".............................................................................................................. .................... 987   WT/DS291/R 
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 Page xxxiii 
  
  "Based on"..................................................................................................................... ........................ 988  
Overall co nclusions............................................................................................................ ................... 989  
(vii) Germany – Bt-176 maize ........................................................................................................9 89 
"Risk asse ssment".............................................................................................................. .................... 989  
"Based on"..................................................................................................................... ........................ 993  
Overall co nclusions............................................................................................................ ................... 994  
(viii) Greece – Topas oilseed rape...................................................................................................9 94 
"Risk asse ssment".............................................................................................................. .................... 994  
"Based on"..................................................................................................................... ........................ 998  
Overall co nclusions............................................................................................................ ................... 999  
(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163) .........................999  
"Risk asse ssment".............................................................................................................. .................. 1000  
"Based on"..................................................................................................................... ...................... 1002  
Overall co nclusions............................................................................................................ ................. 1004  
(x) Luxembourg – Bt-176 maize .................................................................................................1004  
"Risk asse ssment".............................................................................................................. .................. 1005  
"Based on"..................................................................................................................... ...................... 1006  
Overall co nclusions............................................................................................................ ................. 1007  
(d) Consistency with Article 5.7 of the SPS Agreement  and final conclusion regarding 
consistency with Article 5.1 of the SPS Agreement ..............................................................1007  
(i) Austria – T25 maize ............................................................................................................ ..1009  
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1011  
Relevance of the appropriate level of sanitary  or phytosanitary protection from risks................ 1012  
Time at which insufficiency of relevant sc ientific evidence is to be assessed............................. 1016  
(ii) Austria's safeguard meas ure on T25 maize ..........................................................................1019  
Overall co nclusions............................................................................................................ ................. 1020  
(iii) Austria – Bt-176 maize......................................................................................................... .1021  
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1023  
Overall co nclusions............................................................................................................ ................. 1024  
(iv) Austria – MON810 maize......................................................................................................102 5 
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1027  
Overall co nclusions............................................................................................................ ................. 1028  
(v) France – MS1/RF1 oilseed  rape (EC-161)...........................................................................1029  
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1031  
Overall co nclusions............................................................................................................ ................. 1033  
(vi) France – Topas oilseed rape.................................................................................................103 3 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxxiv 
  
  "Insufficiency of relevant  scientific evidence"................................................................................ .... 1036  
Overall co nclusions............................................................................................................ ................. 1037  
(vii) Germany – Bt-176 maize ......................................................................................................103 7 
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1040  
Overall co nclusions............................................................................................................ ................. 1041  
(viii) Greece – Topas oilseed rape.................................................................................................104 1 
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1044  
Overall co nclusions............................................................................................................ ................. 1045  
(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163) .......................1046  
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1048  
Overall co nclusions............................................................................................................ ................. 1050  
(x) Luxembourg – Bt-176 maize .................................................................................................1051  
"Insufficiency of relevant  scientific evidence"................................................................................ .... 1053  
Overall co nclusions............................................................................................................ ................. 1054  
(e) Consistency with Article 5.6 of the SPS Agreement .............................................................1055  
(i) Evaluation..................................................................................................................... ........1055  
(ii) Overall conclusions ............................................................................................................ ..1056  
(f) Consistency with Article 5.5 of the SPS Agreement .............................................................1056  
(i) Evaluation..................................................................................................................... ........1057  
(ii) Overall conclusions ............................................................................................................ ..1057  
(g) Consistency with Article 2.2 of the SPS Agreement .............................................................1058  
(i) First requirement of Article 2.2 ............................................................................................105 9 
(ii) Second and third requiremen ts of Article 2.2 .......................................................................1059  
(iii) Article 5.7.................................................................................................................... ..........1060  
(iv) Overall conclusions ............................................................................................................ ..1060  
(h) Consistency with Article 2.3 of the SPS Agreement .............................................................1061  
(i) Evaluation..................................................................................................................... ........1062  
(ii) Overall conclusions ............................................................................................................ ..1062  
3. Analysis of the safeguard measures in the light of the TBT Agreement .........................1062  
(a) Evaluation ..................................................................................................................... ........1063  
(b) Overall conclusions............................................................................................................ ...1063  
4. Analysis of the safeguard measures in the light of the GATT 1994 ...............................1064  
(a) Consistency with Article III:4 of the GATT 1994................................................................1064  
(i) Evaluation..................................................................................................................... ........1065  
(ii) Overall conclusions ............................................................................................................ ..1065   WT/DS291/R 
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  (b)
 Consistency with Article XI:1 of the GATT 1994................................................................1065  
(i) Evaluation..................................................................................................................... ........1066  
(ii) Overall conclusions ............................................................................................................ ..1066  
VIII.  CONCLUSIONS AND RECOMMENDATIONS............................................................1067  
A. OVERVIEW  OF THE  ISSUES  ADDRESSED  AND  DECIDED  BY THE  PANEL............1067  
B. STRUCTURE  OF THE  PANEL'S  CONCLUSIONS  AND  RECOMMENDATIONS.........1069  
C. COMPLAINT  BY THE  UNITED  STATES  (DS291):  CONCLUSIONS  AND  
RECOMMENDATIONS  OF THE  PANEL..........................................................................1070  
1. General EC moratorium ....................................................................................................1070  
2. Product-specific EC measures ...........................................................................................1071  
3. EC member State safeguard measures .............................................................................1073  
(a) Austria – T2 5 maiz e............................................................................................................ ..1073  
(b) Austria - Bt-176 maize......................................................................................................... .1073  
(c) Austria - MON810 maize......................................................................................................107 3 
(d) France - MS1/RF1 oilseed rape (EC-161) ............................................................................1074  
(e) France - Topas oilseed rape ..................................................................................................10 74 
(f) Germany – Bt-176 maize......................................................................................................107 4 
(g) Greece - Topas oilseed rape..................................................................................................10 75 
(h) Italy - Bt-11 maize (EC-163), MON810 maize, MON809 maize and T25 maize................1075  
(i) Luxembourg – Bt-176 maize ................................................................................................1075  
(j) Nullification or impairment of benefits and recommendations ............................................1076  
D. COMPLAINT  BY CANADA  (DS292):   CONCLUSIONS  AND  
RECOMMENDATIONS  OF THE  PANEL..........................................................................1076  
1. General EC moratorium ....................................................................................................1076  
2. Product-specific EC measures ...........................................................................................1077  
3. EC member State safeguard measures .............................................................................1078  
(a) Austria – T2 5 maiz e............................................................................................................ ..1078  
(b) France - MS1/RF1 oilseed rape (EC-161) ............................................................................1079  
(c) France - Topas oilseed rape ..................................................................................................10 79 
(d) Greece - Topas oilseed rape..................................................................................................10 80 
(e) Italy - Bt-11 maize (EC-163), MON810 maize, MON809 maize and T25 maize................1080  
(f) Nullification or impairment of benefits and recommendations ............................................1081  
E. COMPLAINT  BY ARGENTINA  (DS293):  CONCLUSIONS  AND  
RECOMMENDATIONS  OF THE  PANEL..........................................................................1081  
1. General EC moratorium ....................................................................................................1081  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxxvi 
  
  2.
 Product-specific EC measures ...........................................................................................1082  
3. EC member State safeguard measures .............................................................................1084  
(a) Austria – T2 5 maiz e............................................................................................................ ..1084  
(b) Austria - Bt-176 maize......................................................................................................... .1084  
(c) Austria - MON810 maize......................................................................................................108 5 
(d) Germany – Bt-176 maize......................................................................................................108 5 
(e) Italy - Bt-11 maize (EC-163), MON810 maize and T25 maize............................................1086  
(f) Luxembourg – Bt-176 maize ................................................................................................1087  
(g) Nullification or impairment of benefits and recommendations ............................................1087  
  WT/DS291/R 
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  LIST OF ANNEXES
 
 
ANNEX A 
 
EC ADMINISTRATIVE PROCEDURES FOR GRANTING CONSENTS 
FOR THE DELIBERATE RELEASE OF GMOS INTO THE ENVIRONMENT 
AND FOR NOVEL FOODS AND NOVEL FOOD INGREDIENTS  
 
Contents Page 
Annex A-1  Directive 90/220: EC administrative procedure for granting 
consents for the deliberate release of GMOs into the environment  A-2 
Annex A-2 Directive 2001/18: EC administrative procedure for granting 
consents for the deliberate release of GMOs into the environment  A-4 
Annex A-3 Regulation 258/97: EC administrative procedure for granting 
consents for novel foods and novel food ingredients A-6 
 
 
ANNEX B 
 
TABLES SUMMARIZING THE HISTORY OF THE INDIVIDUAL APPROVAL 
PROCEDURES AT ISSUE IN THIS DISPUTE  
 
 
 
ANNEX C 
 
REPLIES BY THE PARTIES TO QUESTIONS 
POSED BY THE PANEL ON 3 JUNE 2004  
 
Contents Page 
Annex C-1 Reply by the United States to  the question posed by the Panel on 
3 June 2004 C-2 
Annex C-2 Replies by the European Communities to questions posed by the 
Panel on 3 June 2004 C-4 
 
 
ANNEX D 
 
REPLIES BY THE PARTIES TO QU ESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE FI RST SUBSTANTIVE MEETING  
 
Contents Page 
Annex D-1 Replies by the United States to questions posed by the Panel in the 
context of the first substantive meeting D-2 
Annex D-2 Replies by Canada to questions  posed by the Panel in the context of 
the first substantive meeting D-35 
Annex D-3 Replies by Argentina to questions posed by the Panel in the context 
of the first substantive meeting  D-70 
Annex D-4 Replies by the European Communities to questions posed by the 
Panel in the context of the first substantive meeting D-86 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xxxviii 
  
  ANNEX E 
 
REPLIES BY THE PARTIES TO QUESTIONS 
POSED BY OTHER PARTIES IN THE CONTEXT 
OF THE FIRST SUBSTANTIVE MEETING  
 
Contents Page 
Annex E-1 Replies by the United States to questions posed by the European 
Communities E-2 
Annex E-2 Replies by Canada to questions posed by the European 
Communities E-4 
Annex E-3 Replies by Argentina to questions posed by the European 
Communities E-8 
Annex E-4 Replies by the European  Communities to questions posed by 
Argentina E-10 
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 Page xxxix 
  
  ANNEX F 
 
REPLIES BY THE PARTIES TO QU ESTIONS POSED BY THE PANEL 
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING 
AND COMMENTS BY THE PARTIES ON THE OTHER PARTIES' REPLIES 
 
Contents Page 
Annex F-1 Replies by the United States to questions posed by the Panel in the 
context of the second substan tive meeting (7 March 2005) F-2 
Annex F-2 Replies by the United States to additional questions posed by the 
Panel in the context of the second substantive meeting (11 March 2005) F-26 
Annex F-3 Comments by the United States on the replies of the European 
Communities to questions posed by the Panel in the context of the 
second substantive meeting (18 March 2005) F-44 
Annex F-4 Replies by Canada to questions  posed by the Panel in the context of 
the second substantive meeting (7 March 2005) F-56 
Annex F-5 Replies by Canada to additiona l questions posed by the Panel in the 
context of the second substan tive meeting (11 March 2005) F-72 
Annex F-6 Comments by Canada on the re plies of other parties to questions 
posed by the Panel in the context of the second substantive meeting (18 March 2005) F-93 
Annex F-7 Replies by Argentina to questions posed by the Panel in the context 
of the second substantive meeting (7 March 2005) F-110 
Annex F-8 Replies by Argentina to add itional questions posed by the Panel in 
the context of the second substantive meeting (11 March 2005) F-117 
Annex F-9 Replies by the European Communities to questions posed by the 
Panel in the context of the second substantive meeting (7 March 2005) F-123 
Annex F-10 Replies by the European Co mmunities to additional questions posed 
by the Panel in the context of the second substantive meeting (11 March 2005) F-154 
Annex F-11 Comments by the European Communities on the replies by the 
complainants to questions posed by  the Panel in the context of the 
second substantive meeting (18 March 2005) F-174 
 
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WT/DS292/R WT/DS293/R 
Page xl 
  
  ANNEX G 
 
REPLIES BY THIRD PARTIES TO QUESTIONS POSED BY THE PANEL 
AND THE PARTIES 
 
Contents Page 
Annex G-1 Replies by Australia to questions  posed by the Panel and the parties G-2 
Annex G-2 Replies by the Separate Customs Territory of Taiwan, Penghu, 
Kinmen and Matsu to questions posed by the Panel and the parties G-7 
Annex G-3 Reply by El Salvador to the question posed by the United States G-9 
Annex G-4 Reply by Honduras to the question posed by the United States G-10 
Annex G-5 Replies by New Zealand to questions posed by the Panel and the 
parties G-11 
Annex G-6 Replies by Peru to questions posed by the Panel and the parties G-14 
Annex G-7 Reply by Thailand to question posed by the Panel G-16 
 
 
ANNEX H 
 
REPLIES BY THE SCIENTIFIC EXPERTS ADVISING THE PANEL 
TO QUESTIONS POSED BY THE PANEL 
 
 
ANNEX I  
 
COMMENTS BY THE PARTIES ON THE REPLIES BY THE 
SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL 
 
Contents Page 
Annex I-1 Comments by the United States on the replies by the scientific 
experts to the questions posed by the Panel (31 January 2005) I-2 
Annex I-2 Comments by Canada on the replies by the scientific experts to the 
questions posed by the Panel (31 January 2005) I-35 
Annex I-3 Comments by Argentina on the replies by the scientific experts to 
the questions posed by the Panel (31 January 2005) I-80 
Annex I-4 Comments by the European Communities on the replies by the 
scientific experts to the questions posed by the Panel 
(28 January 2005) I-197 
 
 
ANNEX J 
 
TRANSCRIPT OF THE PANEL'S JOINT MEETING WITH SCIENTIFIC EXPERTS 
OF 17 AND 18 FEBRUARY 2005 
 
 
ANNEX K 
 
LETTER OF THE PANEL TO THE PARTIES OF 8 MAY 2006  
  WT/DS291/R 
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 Page xli 
  
  TABLE OF CASES CITED IN THIS REPORT 
 
Short Title Full Case Title and Citation 
Argentina – Textiles and 
Apparel  Panel Report, Argentina – Measures Affecting Imports of Footwear, Textiles, 
Apparel and Other Items , WT/DS56/R, adopted 22 April 1998, as modified by 
Appellate Body Report, WT/DS56/AB/R, DSR 1998:III, 1033 
Australia – Salmon  Appellate Body Report, Australia – Measures Affecting Importation of Salmon , 
WT/DS18/AB/R, adopted 6 November 1998, DSR 1998:VIII, 3327 
Australia – Salmon  Panel Report, Australia – Measures Affecting Importation of Salmon , WT/DS18/R 
and Corr.1, adopted 6 November 1998, as modified by the Appellate Body Report, WT/DS18/AB/R, DSR 1998:VIII, 3407 
Brazil – Desiccated 
Coconut  Appellate Body Report, Brazil – Measures Affe cting Desiccated Coconut , 
WT/DS22/AB/R, adopted 20 March 1997, DSR 1997:I, 167 
Canada – Wheat Exports 
and Grain Imports Appellate Body Report, Canada – Measures Relating to Exports of Wheat and 
Treatment of Imported Grain , WT/DS276/AB/R, adopted 27 September 2004 
Canada – Wheat Exports 
and Grain Imports Panel Report, Canada – Measures Relating to Exports of Wheat and Treatment of 
Imported Grain , WT/DS276/R, adopted 27 September 2004, as upheld by the 
Appellate Body Report, WT/DS276/AB/R 
Chile – Alcoholic Beverages
  Appellate Body Report, Chile – Taxes on Alcoholic Beverages , WT/DS87/AB/R, 
WT/DS110/AB/R, adopted 12 January 2000, DSR 2000:I, 281 
Chile – Price Band System  Appellate Body Report, Chile – Price Band System and Safeguard Measures 
Relating to Certain Agricultural Products , WT/DS207/AB/R, adopted 
23 October 2002, DSR 2002:VIII, 3045 
Chile – Price Band System  Panel Report, Chile – Price Band System and Safeguard Measures Relating to 
Certain Agricultural Products , WT/DS207/R, adopted 23 October 2002, as 
modified by Appellate Body Report, WT/DS207AB/R, DSR 2002:VIII, 3127 
Dominican Republic – 
Import and Sale of Cigarettes Appellate Body Report, Dominican Republic – Measures Affecting the 
Importation and Internal Sale of Cigarettes , WT/DS302/AB/R, adopted 
19 May 2005 
Dominican Republic – 
Import and Sale of 
Cigarettes Panel Report, Dominican Republic – Measures Affecting the Importation and 
Internal Sale of Cigarettes , WT/DS302/R, adopted 19 May 2005, as modified by 
Appellate Body Report, WT/DS302/AB/R 
EC – Asbestos  Appellate Body Report, European Communities – Measures Affecting Asbestos and 
Asbestos-Containing Products , WT/DS135/AB/R, adopted 5 April 2001, 
DSR 2001:VII, 3243 
EC – Asbestos  Panel Report, European Communities – Measures Af fecting Asbestos and Asbestos-
Containing Products , WT/DS135/R and Add.1, adopted 5 April 2001, as modified 
by Appellate Body Report, WT/DS135/AB/R, DSR 2001:VIII, 3305 
EC – Bananas III  Appellate Body Report, European Communities – Regime for the Importation, Sale 
and Distribution of Bananas , WT/DS27/AB/R, adopted 25 September 1997, 
DSR 1997:II, 591 
EC – Bed Linen  Appellate Body Report, European Communities – Anti-Dumping Duties on Imports 
of Cotton-Type Bed Linen from India , WT/DS141/AB/R, adopted 12 March 2001, 
DSR 2001:V, 2049 
EC – Bed Linen  Panel Report, European Communities – Anti-Dumping Duties on Imports of Cotton-
Type Bed Linen from India , WT/DS141/R, adopted 12 March 2001, as modified by 
the Appellate Body Report, WT/DS141/AB/R, DSR 2001:VI, 2077 
EC – Chicken Cuts Appellate Body Report, European  Communities – Customs Classification of 
Frozen Boneless Chicken Cuts , WT/DS269/AB/R, WT/DS286/AB/R, adopted 
27 September 2005 
EC – Commercial Vessels Panel Report, European Communities – Measures Affecting Trade in Commercial 
Vessels , WT/DS301/R, adopted 20 June 2005 
EC – Computer Equipment  Appellate Body Report, European Communities – Customs Classification of 
Certain Computer Equipment , WT/DS62/AB/R, WT/DS67/AB/R, 
WT/DS68/AB/R, adopted 22 June 1998, DSR 1998:V, 1851 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xlii 
  
  Short Title Full Case Title and Citation 
EC – Hormones  Appellate Body Report, EC Measures Concerning Meat and Meat Products 
(Hormones) , WT/DS26/AB/R, WT/DS48/AB/R, adopted 13 February 1998, 
DSR 1998:I, 135 
EC – Hormones (Canada)  Panel Report, EC Measures Concerning Meat  and Meat Products (Hormones)  – 
Complaint by Canada , WT/DS48/R/CAN, adopted 13 February 1998, as modified 
by the Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R, 
DSR 1998:II, 235 
EC – Hormones (US)  Panel Report, EC Measures Concerning Meat  and Meat Products (Hormones)  – 
Complaint by the United States , WT/DS26/R/USA, adopted 13 February 1998, as 
modified by the Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R, 
DSR 1998:III, 699 
EC – Sardines  Appellate Body Report, European Communities – Trade Description of Sardines , 
WT/DS231/AB/R, adopted 23 October 2002 
EC – Tariff Preferences Appellate Body Report, European Communities – Conditions for the Granting of 
Tariff Preferences to Developing Countries , WT/DS246/AB/R, adopted 20 April 
2004 
Guatemala – Cement I  Appellate Body Report, Guatemala – Anti-Dumping Investigation Regarding 
Portland Cement from Mexico , WT/DS60/AB/R, adopted 25 November 1998, 
DSR 1998:IX, 3767 
India – Autos  Panel Report, India – Measures Affecting the Automotive Sector , WT/DS146/R, 
WT/DS175/R and Corr.1, adopted 5 April 2002 
India – Patents (US)  Appellate Body Report, India – Patent Protection for Pharmaceutical and 
Agricultural Chemical Products , WT/DS50/AB/R, adopted 16 January 1998, 
DSR 1998:I, 9 
Indonesia – Autos  Panel Report, Indonesia – Certain Measures Affecting the Automobile Industry , 
WT/DS54/R, WT/DS55/R, WT/DS59/R, WT/DS64/R and Corr.1, 2, 3, and 4, 
adopted 23 July 1998, DSR 1998:VI, 2201 
Japan – Agricultural 
Products II  Appellate Body Report, Japan – Measures Affecting Agricultural Products , 
WT/DS76/AB/R, adopted 19 March 1999, DSR 1999:I, 277 
Japan – Agricultural Products II
  Panel Report, Japan – Measures Affecting Agricultural Products , WT/DS76/R, 
adopted 19 March 1999, as modified by the Appellate Body Report, 
WT/DS76/AB/R, DSR 1999:I, 315 
Japan – Alcoholic 
Beverages II  Appellate Body Report, Japan – Taxes on Alcoholic Beverages , WT/DS8/AB/R, 
WT/DS10/AB/R, WT/DS11/AB/R, adopted 1 November 1996, DSR 1996:I, 97  
Japan – Apples  Appellate Body Report, Japan – Measures Affecting the Importation of Apples , 
WT/DS245/AB/R, adopted 10 December 2003, DSR 2003:IX, 4391 
Japan – Apples  Panel Report, Japan – Measures Affecting the Importation of Apples , WT/DS245/R, 
adopted 10 December 2003, as upheld by the Appellate Body Report, 
WT/DS245/AB/R, DSR 2003:IX, 4481  
Japan – Semi-Conductors GATT Panel Report, Japan – Trade in Semi-Conductors , adopted 4 May 1988, 
BISD 35S/116 
Korea – Dairy  Appellate Body Report, Korea – Definitive Safeguard Measure on Imports of 
Certain Dairy Products , WT/DS98/AB/R, adopted 12 January 2000, DSR 2000:I, 3 
Korea – Dairy  Panel Report , Korea – Definitive Safeguard Measure on Imports of Certain Dairy 
Products , WT/DS98/R and Corr.1, adopted 12 January 2000, as modified by 
Appellate Body Report, WT/DS98/AB/R, DSR 2000:I, 49. 
Mexico – Corn Syrup  Panel Report, Mexico – Anti-Dumping Investigation of High Fructose Corn Syrup 
(HFCS) from the United States , WT/DS132/R and Corr.1, adopted 
24 February 2000, DSR 2000:III, 1345 
Mexico – Corn Syrup 
(Article 21.5 – US)  Appellate Body Report, Mexico – Anti-Dumping Investigation of High Fructose 
Corn Syrup (HFCS) from the United States – Recourse to Article 21.5 of the DSU  
by the United States , WT/DS132/AB/RW, adopted 21 November 2001, DSR 
2001:XIII, 6675  WT/DS291/R 
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  Short Title Full Case Title and Citation 
Thailand – H-Beams  Appellate Body Report, Thailand – Anti-Dumping Duties on Angles, Shapes and 
Sections of Iron or Non-Alloy Steel and H-Beams from Poland , WT/DS122/AB/R, 
adopted 5 April 2001, DSR 2001:VII, 2701 
US – Carbon Steel  Appellate Body Report, United States – Countervailing Duties on Certain 
Corrosion-Resistant Carbon Steel Flat Products from Germany , WT/DS213/AB/R 
and Corr.1, adopted 19 December 2002 
US – Carbon Steel  Panel Report, United States – Countervailing Duties on Certain Corrosion-
Resistant Carbon Steel Flat Products from Germany , WT/DS213/R and Corr.1, 
adopted 19 December 2002, as modified by the Appellate Body Report, 
WT/DS213/AB/R 
US – Certain EC Products  Appellate Body Report, United States – Import Measures on Certain Products from 
the European Communities , WT/DS165/AB/R, adopted 10 January 2001, 
DSR 2001:I, 373 
US – Certain EC Products  Panel Report, United States – Import Measures on Certain Products from the 
European Communities , WT/DS165/R and Add.1, adopted 10 January 2001, as 
modified by Appellate Body Report, WT/DS165/AB/R, DSR 2001:II, 413 
US – Corrosion-Resistant Steel Sunset Review
  Appellate Body Report, United States – Sunset Review of Anti-Dumping Duties on 
Corrosion-Resistant Carbon Steel Flat Products from Japan , WT/DS244/AB/R, 
adopted 9 January 2004  
US – Corrosion-Resistant 
Steel Sunset Review  Panel Report, United States – Sunset Review of Anti-Dumping Duties on 
Corrosion-Resistant Carbon Steel Flat Products from Japan , WT/DS244/R, 
adopted 9 January 2004, as modified by the Appellate Body Report, 
WTDS244/AB/R  
US – Cotton Yarn  Appellate Body Report, United States – Transitional Safeguard Measure on 
Combed Cotton Yarn from Pakistan , WT/DS192/AB/R, adopted 5 November 2001, 
DSR 2001:XII, 6027 
US – Export Restraints  Panel Report, United States – Measures Treating Exports Restraints as Subsidies , 
WT/DS194/R and Corr.2, adopted 23 August 2001, DSR 2001:XI, 5767 
US – FSC  Appellate Body Report, United States – Tax Treatment for "Foreign Sales 
Corporations" , WT/DS108/AB/R, adopted 20 March 2000, DSR 2000:III, 1619 
US – FSC 
(Article 21.5 – EC)  Appellate Body Report, United States – Tax Treatment for "Foreign Sales 
Corporations" – Recourse to Articl e 21.5 of the DSU by the European 
Communities , WT/DS108/AB/RW, adopted 29 January 2002 
US – Gambling Appellate Body Report, United States – Measures Affecting the Cross-Border 
Supply of Gambling and Betting Services , WT/DS285/AB/R, adopted 20 April 
2005 
US – Gasoline  Appellate Body Report, United States – Standards for Reformulated and 
Conventional Gasoline , WT/DS2/AB/R, adopted 20 May 1996, DSR 1996:I, 3 
US – Gasoline  Panel Report, United States – Standards for Reformulated and Conventional 
Gasoline , WT/DS2/R, adopted 20 May 1996, as modified by Appellate Body 
Report, WT/DS2/AB/R, DSR 1996:I, 29 
US – Lamb  Appellate Body Report, United States – Safeguard Measures on Imports of Fresh, 
Chilled or Frozen Lamb Meat from New Zealand and Australia , WT/DS177/AB/R, 
WT/DS178/AB/R, adopted 16 May 2001, DSR 2001:IX, 4051 
US – Offset Act  (Byrd Amendment)  Appellate Body Report, United States – Continued Dumping and Subsidy Offset Act 
of 2000 , WT/DS217/AB/R, WT/DS234/AB/R, adopted 27 January 2003 
US – Section 211  
Appropriations Act  Appellate Body Report, United States – Section 211 Omnibus Appropriations Act 
of 1998 , WT/DS176/AB/R, adopted 1 February 2002, DSR 2002:II, 589 
US – Shrimp  Appellate Body Report, United States – Import Prohibition of Certain Shrimp and 
Shrimp Products , WT/DS58/AB/R, adopted 6 November 1998, 
DSR 1998:VII, 2755 
US – Steel Plate  Panel Report, United States – Anti-Dumping and Countervailing Measures on Steel 
Plate from India , WT/DS206/R and Corr.1, adopted 29 July 2002 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xliv 
  
  Short Title Full Case Title and Citation 
US – Steel Safeguards Panel Reports, United States – Definitive Safeguard Measures on Imports of 
Certain Steel Products , WT/DS248, WT/DS249, WT/DS251, WT/DS252, 
WT/DS253, WT/DS254, WT/D S258, WT/DS259, adopted 10 December 2003, as 
modified by Appellate Body Report, WT/DS248AB/R, WT/DS249AB/R, 
WT/DS251AB/R, WT/DS252AB/R, WT/DS253AB/R, WT/DS254AB/R, 
WT/DS258AB/R, WT/DS259AB/R, DSR 2003:VIII, 3271  
US – Upland Cotton Appellate Body Report, United States – Subsidies on Upland Cotton , 
WT/DS267/AB/R, adopted 21 March 2005 
US – Wool Shirts and 
Blouses  Appellate Body Report, United States – Measure Affecting Imports of Woven Wool 
Shirts and Blouses from India , WT/DS33/AB/R and Corr.1, adopted 23 May 1997, 
DSR 1997:I, 323 
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 Page xlv 
  
  LIST OF ABBREVIATIONS 
 
ARMG Antibiotic resistance marker genes 
At. Attachment 
Bt Bacillus thuringiensis  
CA Competent authority 
CBD  Convention on Biological Diversity  Commission European Commission  
Council  European Council of Ministers  
DNA Deoxyribonucleic acid DSB Dispute Settlement Body DSU Understanding on Rules and Pro cedures Governing the Settlement 
of Disputes 
EC European Communities 
ECJ European Court of Justice  
EFSA European Food Safety Authority  EU European Union FAO Food and Agriculture Organization of the United Nations GATT 1994 General Agreement on Tariffs and Trade  1994  
GM Genetically modified 
GMHT  Genetically modified and herbicide tolerant GMOs  Genetically modified organisms  IPPC International Plant Protection Convention 
ISPM International Standard  for Phytosanitary Measures 
LMOs Living modified organisms WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xlvi 
  
  OECD Organisation for Economic  Cooperation and Development 
OIE World Organization for Animal Health  SCF EC Scientific Committee on Food 
SCP EC Scientific Committee on Plants 
SNIF Summary Notification Information Form SPS Sanitary and phytosanitary 
SPS Agreement Agreement on the Applic ation of Sanitary and Phytosanitary 
Measures  
TBT Agreement Agreement on Technical Barriers to Trade  
UNEP United Nations Environmental Programme  
US United States of America WHO World Health Organisation 
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 WT/DS293/R 
 Page xlvii 
  
  SHORT AND FULL TITLES OF PRODUCTS 
 
Short title of product 
(in alphabetical order) Full Title of Product and  
EC Exhibit number 
COTTON  
Bt-531 cotton Monsanto Bt cotton (531)  
C/ES/96//02 (EC chronology 65) 
BXN cotton Stoneville BXN cotton (10215, 10222, 10224)  
C/ES/99/01 (EC chronology 73) 
RR-1445 cotton Monsanto Roundup Ready cotton (RRC1445)  
C/ES/97/01 (EC chronology 66) 
MAIZE 
Bt-11 maize (EC-69) Syngenta glufosinate tolerant and Bt resistant (Bt-11) maize  
C/F/96/05-10 (EC chronology 69) 
Bt-11 maize (EC-80) Syngenta Bt-11 maize  
C/ES/98/02 (EC chronology 80) 
Bt-11 maize (EC-163) Bt-11 maize  
C/GB/96/M4/1  (EC chronology 163) 
Bt-11 sweet maize (food) Syngenta Bt-11 sweet maize  
(EC chronology 92) 
Bt-176 maize Bt 176 maize (Ciba Geigy, now Syngenta Seeds )  
C/F/94/11-03  (EC chronology 158)  
Bt-1507 maize (EC-74) Pioneer/Dow AgroSciences Bt maize Cry1F (1507)  
C/NL/00/10 (EC chronology 74)  
Bt-1507 maize (EC-75) Pioneer/Dow AgroSciences Bt maize Cry1F (1507)  
C/ES/01/01(EC chronology 75)  
Bt-1507 maize (food)  Pioneer/Dow AgroSciences Bt maize Cry1F (1507)  
(EC chronology 95)  
GA21 maize (EC-78) Monsanto Roundup Ready maize(GA21)  
C/ES/98/01 (EC Chronology 78)  
GA21 maize (EC-85) Monsanto Roundup Ready maize(GA21)  
C/GB/97/M3/2 (EC Chronology 85)  
GA21 maize (food) Monsanto Roundup Ready maize(GA21)  
(EC Chronology 91)  
MON809 maize Pioneer Bt maize (MON809)  
C/F/95/12-01/B (EC chronology 83)  
MON809 maize (food) Monsanto 809 maize  
C/F/95/12-01/B (EC chronology 157) 
MON810 maize Monsanto 810 maize  
C/F/95/12-02  (EC chronology 159) WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page xlviii 
  
  Short title of product 
(in alphabetical order) Full Title of Product and  
EC Exhibit number 
MON810 x GA21 maize Monsanto MaisGard & Roundup Ready (MON810 & GA21) 
maize (stack)  
C/ES/99/02 (EC chronology 82) 
MON810 x GA21 maize (food) Monsanto MaisGard & Roundup Ready (MON810 & GA21)  
maize (stack)  
(EC Chronology 94) 
NK603 maize  
 Monsanto Roundup Ready maize (NK603)  
C/ES/00/01 (EC Chronology 76)  
NK603 maize (food) Monsanto Roundup Ready maize (NK603)  
(EC Chronology 96)  
T14 maize Agrevo maize T14  maize  
C/F/96/06/12  (EC Chronology 156) 
T25 maize 
 T25 maize (AgrEvo, then Aventis Cropscience )  
C/F/95/12-07  (EC chronology 160)  
T25 x MON810 maize Pioneer Liberty Link and Bt (T25 and MON810) maize  
C/NL/98/08 (EC chronology 86)  
T25 x MON810 maize (food) Pioneer Liberty Link and Bt (T25 and MON810) maize  
(EC chronology 101)  
OILSEED RAPE 
Falcon oilseed rape Bayer oilseed rape (Falcon GS40/90)  
C/DE/96/05 (EC Chronology 62) 
Liberator oilseed rape Bayer winter oilseed rape(Liberator pHoe6/Ac)  
C/D/98/06 (EC Chronology 68)  
LL oilseed rape Bayer Liberty Link oilseed rape (T45 & Topas 19/2)  
C/GB/99/M5/2 (EC chronology 72) 
MS1/RF1 oilseed rape (EC-89) Bayer oilseed rape (MS1/RF1)  
C/F/95/01A (EC chronology 89) 
MS1/RF1 oilseed rape (EC-161) Bayer oilseed rape (MS1/RF1)  
C/UK/94/M1/1   (EC chronology 161) 
MS1/RF2 oilseed rape Bayer oilseed rape (MS1/RF2)  
C/F/95/01B (EC chronology 90) 
MS8/RF3 oilseed rape Bayer hybrid oilseed rape (MS8/RF3)  
C/BE/96/01 (EC Chronology 63)  
RR oilseed rape (EC-70) Monsanto Roundup Ready oilseed rape(GT73)  
C/NL/98/11 (EC Chronology 70)  
RR oilseed rape (EC-79) Monsanto Roundup Ready oilseed rape(GT73)  
C/F/9506/011 (EC Chronology 79)   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page xlix 
  
  Short title of product 
(in alphabetical order) Full Title of Product and  
EC Exhibit number 
Topas oilseed rape Oilseed Rape Topas 19/2 (AgrEvo )  
C/UK/95/M5/1  (EC chronology 162) 
SOYBEANS  
High-oleic soybeans  Pioneer/Dupont high-oleic soybeans (260-05)  
C/NL/98/09 (EC chronology 87)  
High-oleic soybeans (food) Pioneer/Dupont high-oleic soybeans (260-05)  
(EC chronology 99)  
LL soybeans (EC-71) Bayer Liberty Link soybeans (A2704-12 and A5547-127)  
C/BE/98/01 (EC chronology 71)  
LL soybeans (EC-81) Bayer Liberty Link soybeans (A2704-12 and A5547-127)  
C/PT/99/01 (EC chronology 81)  
LL soybeans (food) Bayer Liberty Link soybeans (A2704-12 and A5547-127)  
(EC chronology 93) 
MON soybeans Monsanto herbicide-resistant soybeans  
C/UK/94/M3/1 
OTHER  
BXN tobacco SEITA Tobacco tolerant to bromoxynil  
C/F/93/08-02 
RR fodder beet Trifolium/Monsanto/Danisco Roundup Ready fodder beet 
(A5/15)  
C/DK/97/01 (EC chronology 64) 
RR sugar beet  Monsanto/Syngenta Roundup Ready sugar beet (77)  
C/BE/99/01 (EC chronology 88) 
RR sugar beet (food) Monsanto/Syngenta Roundup Ready sugar beet (77)  
(EC chronology 102) 
Transgenic green-hearted chicory Bejo-Zaden Green hearted chicory 
C/NL/96/05 (EC chronology 110)  
Transgenic green-hearted chicory 
(food) Bejo-Zaden Transgenic Green hearted chicory  
(EC chronology 98)  
Transgenic potato Amylogene starch potato  
C/SE/96/3501  (EC chronology 67) 
Transgenic red-hearted chicory Bejo Zaden red-hearted chicory (RM3-3, RM3-4, RM3-6)  
C/NL/94/25 (breeding activities)  
C/NL/94/25/A(food/feed) (EC chronology 77)  
Transgenic red-hearted chicory 
(food) Bejo Zaden red-hearted chicory (RM3-3, RM3-4, RM3-6)  
(EC chronology 97)  
Transgenic tomato Zeneca extended shelf life tomato (TGT7-F)  
C/ES/96/01 (EC chronology 84) WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page l 
  
  Short title of product 
(in alphabetical order) Full Title of Product and  
EC Exhibit number 
Transgenic tomato (food) Zeneca extended shelf life tomato (TGT7-F)  
(EC chronology 100) 
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1 
  
  I. INTRODUCTION 
A. C
OMPLAINT OF THE UNITED STATES  
1.1 On 13 May 2003, the United States requested consultations with the European Communities 
pursuant to Article 4 of the Understanding on Rules and Procedures Governing the Settlement of 
Disputes  ("DSU"), Article 11 of the Agreement on the Application of Sanitary and Phytosanitary 
Measures  ("SPS Agreement "), Article 19 of the Agreement on Agriculture , Article 14 of the 
Agreement on Technical Barriers to Trade  ("TBT Agreement ") and Article XXII of the General 
Agreement on Tariffs and Trade 1994  ("GATT 1994") with regard to certain measures taken by the 
European Communities and its me mber States affecting products of biotechnology ("biotech 
products").1 
1.2 On 19 June 2003, the United States and the European Communities held the requested 
consultations, but failed to reach a mutually satisfactory resolution of the matter.   
1.3 On 7 August 2003, the United States requested the establishment of a panel to examine the 
matter.2   
B. COMPLAINT OF CANADA  
1.4 On 13 May 2003, Canada requested consultati ons with the European Communities pursuant 
to Article 4 of the DSU, Article XXII of the GATT 1994, Article 11 of the SPS Agreement , Article 19 
of the Agreement on Agriculture , and Article 14 of the TBT Agreement , concerning measures 
affecting the approval and marketi ng of products that contain, consist of, or are produced from, 
genetically modified organisms.3 
1.5 On 25 June 2003, Canada and the European Co mmunities held the requ ested consultations, 
but failed to reach a mutually satisfactory resolution of the matter.   
1.6 On 7 August 2003, Canada requested the estab lishment of a panel to examine the matter.4   
C. COMPLAINT OF ARGENTINA  
1.7 On 14 May 2003, Argentina requested consu ltations with the European Communities 
pursuant to Article 4 of the DSU, Article  11.1 of the SPS Agreement , Article 19 of the Agreement on 
Agriculture , Article 14.1 of the TBT Agreement , and Article XXII.1 of the GATT 1994 with regard to 
certain measures taken by the European Communities and their member States which affect products of biotechnology.
5 
1.8 On 19 June 2003, Argentina and the European Communities held the requested consultations, 
but failed to reach a mutually satisfactory resolution of the matter.   
1.9 On 7 August 2003, Argentina requested the estab lishment of a panel to examine the matter.6   
                                                      
1 WT/DS291/1. 
2 WT/DS291/23. 
3 WT/DS292/1. 
4 WT/DS292/17. 
5 WT/DS293/1. 
6 WT/DS293/17. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 2 
  
  D. E
STABLISHMENT AND COMPOSITION OF THE PANEL  
1.10 At its meeting of 29 August 2003, the Dis pute Settlement Body established a single panel 
pursuant to the requests of the United States in document WT/DS291/23, Canada in document 
WT/DS292/17 and Argentina in document WT/DS293/17 , in accordance with Articles 6 and 9 of the 
DSU. 
1.11 At that meeting, the Parties to the dispute al so agreed that the Panel should have standard 
terms of reference. The terms of reference are, therefore, the following7: 
"To examine, in the light of the relevant provisions of the covered agreements cited 
by the United States in document WT/DS 291/23, Canada in document WT/DS292/17 
and Argentina in document WT/DS293/17,  the matter referred to the DSB by the 
United States, Canada and Argentina in t hose documents, and to make such findings 
as will assist the DSB in making the recommendations or in giving the rulings provided for in those agreements." 
1.12 On 23 February 2004, the United States, Canada and Argentina requested the Director-
General to determine the composition of the Panel, pu rsuant to paragraph 7 of Article 8 of the DSU.  
On 4 March 2004, the Director-General composed the Panel as follows
8: 
Chairperson: Mr Christian Häberli 
  Members: Mr Mohan Kumar 
   Professor Akio Shimizu 
 1.13 Argentina (in respect of the United States' and Canada's complaints), Australia, Brazil, 
Canada (in respect of the United States' and Ar gentina's complaints), Chile, China, Colombia, 
El Salvador, Honduras, Mexico, New Zealand, No rway, Paraguay, Peru, Chinese Taipei, Thailand, 
Uruguay and the United States (in respect of Canada's  and Argentina's complaints) have reserved their 
rights to participate in the Panel proceedings as Third Parties. 
1.14 On 8 March 2004 the Panel received a prelim inary written submission from the European 
Communities requesting the Panel to make an early ruling to the effect that the requests for the 
establishment of a panel made respectively, by the United States, Canada and Argentina fail to 
comply with the requirements of Article 6.2 of the DSU. 
1.15 The Panel requested the United States, Canada and Argentina to provide a preliminary written 
submission in response to the European Communitie s' preliminary submission.  On 24 March 2003, 
the Panel received preliminary written submissions from the United States, Canada and Argentina.  
1.16 On 8 April 2004, the Panel issued a "Prelimina ry Ruling by the Panel on the Consistency of 
the Complaining Parties' Panel Requests with Article  6.2 of the DSU" finding that the complaining 
parties' requests for the establishment of a panel of 7 August 2004 (d ocuments WT/DS291/23, 
WT/DS292/17 and WT/DS293/17) met the requirements of Article 6.2 of the DSU.  
                                                     
 
7 WT/DSB/M/155. 
8 WT/DS291/24, WT/DS292/18 and WT/DS293/18.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 3 
  
  E. P
ANEL PROCEEDINGS  
1.17 The Panel met with the Parties on 2-4 June 2004 for the first substantive meeting.  It met with 
the Third Parties in a special session on 3 June 2004.   The Panel in this case also sought the advice of 
scientific and technical experts and met with them in the presence of the Parties on 17-18 February 
2005. The Panel held the second substantive meeti ng with the Parties on 21-22 February 2005.   
1.18 On 7 February 2006, the Panel issued its inte rim reports to the Parties.  On 17 March and 
19 April 2006, the Panel received comments from the Parties on the interim reports.  None of the 
Parties requested an interim review meeting.  On 10 May 2006, the Panel issued its final reports to the 
Parties.  
II. FACTUAL ASPECTS 
2.1 This dispute concerns two distinct matters: (1 ) the operation and application by the European 
Communities of its regime for approval of biotech  products; and (2) certain measures adopted and 
maintained by EC member States prohibiting or r estricting the marketing of biotech products.  
2.2 "Biotech products" in this dispute refers to pl ant cultivars that have been developed through 
recombinant deoxyribonucleic acid ("recombinant DNA") technology.   
2.3 The European Communities' regime for approval of  biotech products consists of two primary 
legal instruments:  EC Directive 2001/18 (hereinafter "Directive 2001/18")9 (and its predecessor, EC 
Directive 90/220 (hereinafter "Directive 90/220")10) governing "the deliberate release into the 
environment of genetically modified organism s" and EC Regulation 258/97 (hereinafter 
"Regulation 258/97")11 regulating "novel foods and novel food ingredients". 
2.4 The objective of the EC regime is to protect hum an health and the environment.  To achieve 
these objectives, the applicable legislation requir es the European Communities to conduct a case-by-
case evaluation of the potential risks biotech pr oducts might pose to human health and the 
environment.  On the basis of that evaluation, the marketing of a particular biotech product is either 
approved or not.  The relevant legal instruments out line the administrative procedure to be conducted 
in the event a company seeks to  obtain approval to place a biotech product on the market and the 
standards by which an application for approval is evaluated. 
2.5 The measures maintained by EC member States are linked to the EC regime for approval of 
biotech products.  The above-noted EC legislation – Directive 2001/18 (and its predecessor, Directive 90/220) governing "the deli berate release into the environment of genetically modified 
organisms" and Regulation 258/97 regulating " novel foods and novel food ingredients" – under 
certain conditions permits EC member States to adopt "safeguard" measures in respect of biotech products that have obtained approval for EC-wide marketing.  More particularly, individual EC 
member States may provisionally restrict or prohibit the use and/or sale of an approved biotech product in their own territory if these member States  have detailed grounds fo r considering, based on 
new or additional information or scientific knowle dge, that the particular product poses a risk to 
human health or the environment.  In cases wher e a member State adopts a "safeguard" measure, it 
must inform other EC member States and the Commission of the action it has taken and a decision on 
                                                     
 
9 Directive 2001/18/EC, O.J. 17.4.2001 L106/1. 
10 Directive 90/220/EEC, O.J. 8.5.1990 L117/15, preamble, as amended by Directive 94/15/EC, O.J.  
22.4.1994 L103, and Directive 97/35/EC, O.J. 27.6.1997 L169. 
11 Regulation (EC) No. 258/97, O.J. 14.2.1997 L043/1. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 4 
  
  the member State "safeguard" measure must then be taken at Community level within a prescribed 
time period.  
III. COMPLAINING PARTIES' REQUESTS FOR FINDINGS AND 
RECOMMENDATIONS 
3.1 Below is a summary of the complaining partie s' requests for findings and recommendations as 
set out in their requests for the establishment of a panel.  
A. U
NITED STATES  
3.2 The United States, in its request for establishment of a panel12, requests the Panel to find that 
the measures at issue are inconsistent with: 
(a) Articles 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7 a nd 8, and Annexes B(1), B(2), B(5), C(1)(a), 
C(1)(b), and C(1)(e) of the SPS Agreement ; 
(b) Articles I:1, III:4, X:1, and XI:1 of the GATT 1994;  
(c) Article 4.2 of Agreement on Agriculture ;  and 
(d) Articles 2.1, 2.2, 2.8, 2.9, 2.11, 2.12, 5.1.1, 5.1.2, 5.2.1, 5.2.2, 5.6 and 5.8 of the 
TBT Agreement .  
3.3 The United States also requests the Panel to find that the measures at issue nullify or impair 
benefits accruing to the United States directly  or indirectly under the cited agreements. 
B. CANADA  
3.4 Canada, in its request for establishment of a panel13, requests the Panel to find that the 
measures at issue are inconsistent with: 
(a) Articles 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8,  and paragraphs 1, 2 and 5 of Annex B, and 
paragraphs 1(a), 1(b), 1(c), and 1(e) of Annex C of the SPS Agreement ; 
(b) Articles 2.1, 2.2, 2.8, 2.9, 2.11, 2.12, 5.1, 5.2.1, 5.2.2, 5.2.3, 5.6 and 5.8 of the 
TBT Agreement ; 
(c) Articles I:1, III:4, X:1 and XI:1 of the GATT 1994; 
(d) Article 4.2 of the Agreement on Agriculture . 
3.5 Canada also requests the Panel to find that that the measures at issue nullify or impair benefits 
accruing to Canada directly or i ndirectly under the cited agreemen ts.  Canada further requests the 
Panel to find that the measures at issue nullify and im pair benefits accruing to Canada in the sense of 
Article XXIII:1(b) of the GATT 1994. 
                                                      
12 WT/DS291/23. 
13 WT/DS292/17.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 5 
  
  C. A
RGENTINA  
3.6 Argentina, in its request for establishment of a panel14, requests the Panel to find that the 
measures at issue are inconsistent with:  
(a) Articles 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8 and 10.1 and Annexes B(1) and (5) and 
C(1)(a), (b), (c), (d) and (e) of the SPS Agreement ; 
(b) Article 4.2 of the Agreement on Agriculture ; 
(c) Articles I.1, III.4, X.1, X.3(a) and XI.1 of the GATT 1994; 
(d) Articles 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.6, 5.8 and 12 of the 
TBT Agreement . 
3.7 Argentina also requests the Panel to find that  the measures at issue nullify or impair the 
benefits accruing to Argent ina under cited agreements. 
IV. ARGUMENTS OF THE PARTIES 
4.1 The arguments of the parties are set out in thei r written and oral submissions to the Panel and 
in their answers to questions. The parties' argume nts as presented in their submissions are summarized 
in this Section.15  
A. PRELIMINARY WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES  
1. Introduction 
4.2 The European Communities submits that the requests for the establishment of a panel 
(hereinafter "Requests") made respectively by the United States16, Canada17 and Argentina18 fail to 
comply with the requirements of Article 6.2 of the DSU. 
4.3 The Requests in the present case neither identif y the specific measures at issue nor do they 
provide a brief summary of the legal basis of the co mplaint sufficient to present the problem clearly.  
These are two requirements provided by Article 6.2 of the DSU which form the basis for the panel's term of reference under Article 7.1 of the DSU ( US – Carbon Steel para. 125). The purposes  of these 
two requirements are: to define the scope of the dispute and to serve the due process objective by 
notifying the parties and third parties of  the nature of the complainant's case ( ibidem , para. 126). 
4.4 Given the deficiencies pointed out above, neith er can the Panel's jurisdiction  be clearly 
defined, nor is the European Communities able to properly prepare its defence. Taking into 
consideration that these are two fundamental require ments in dispute settlement proceedings, it is of 
the utmost importance that the issues raised by th e Requests are clarified at the earliest juncture 
possible. The European Communities, therefore, resp ectfully requests the Panel to issue a preliminary 
ruling on Article 6.2 in these proceedings. 
                                                     
 
14 WT/DS293/17. 
15 The summaries of the parties' arguments below are based on the executive summaries submitted by 
the parties where the parties made ava ilable such summaries to the Panel. 
16 WT/DS291/23. 
17 WT/DS292/17. 
18 WT/DS293/17. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 6 
  
  2. The Panel requests fail to identify the "specific measure at issue"  
4.5 The Requests do not comply with Article 6.2 in that they fail to identify the specific measure 
at issue.  As the Panel in Canada – Wheat Exports and Grain Imports  has stated, a panel request 
"must establish the identity of th e precise measures at issue."
19 The Panel has underlined the 
importance of the "specificity" requirement by pointing to the difference in wording between 
Article 6.2 and Article 4.4 of the DSU.  
4.6 Whether the actual terms used in a panel requ est are sufficiently precise to "identify the 
measure at issue" under Article 6.2, according to  the Appellate Body depends upon whether they 
satisfy the purposes of the requirements of that pr ovision (jurisdiction and due process) and must be 
determined on a case by case basis.20 
4.7 Applying these principles, the Panel, in the above case Canada – Wheat Exports and Grain 
Imports , has provided two further indications on how to assess "specificity" putting a particular 
emphasis on the safeguarding of due process rights.21 
4.8 First, the panel held that, while it is not neces sarily required for a request to explicitly specify 
measures of general application by  name, date of adoption etc., "sufficient information must be 
provided in the request for establishment of a pane l itself that effectively identifies the precise 
measures at issue."22 Sufficiency of the information depends, on whether it serves the purposes of 
Article 6.2 (in particular due process objective) and on specific circumstances of each case ( ibidem , 
para. 20). 
4.9 Second, the Panel had made it clear that it considered due process to require that the 
complaining party fully assumed the burden of identifying the specific measures under challenge 
namely by bearing the risk of any lack of precision in the panel request (para. 25).  
(a) The "measures" as described in the Requests 
4.10 The Requests refer to a "moratoriu m" (United States, Canada) or " de facto  moratorium" 
(Argentina) which the European Communities allege dly has applied (United States, Argentina) or 
maintained (Canada) since October 1998.23  They then each list the "me asures at issue", describing in 
ways similar to each other, two distinct measures, namely, on the one hand the suspension by the European Communities of approval of biotech products  and on the other, the failure by the European 
Communities to consider for approval a pplications for the biotech products.
24 
                                                      
19 Panel Report, Canada – Wheat Exports and Grain Imports , Preliminary Ruling, para. 14. 
20 See also Panel Report, Canada – Wheat Exports and Grain Imports , Preliminary Ruling, para. 17. 
21 The Panel concluded on a violation of the specificity requirement in Article 6.2.  It found that the 
identification of the measure at issu e had created "significant uncertainty"  regarding the identity of the precise 
measure at issue thus "impairing the defendant's ability  to begin preparing its defence in a meaningful way" .  
See, ibidem , para. 28. 
22 Panel Report, Canada – Wheat Exports and Grain Imports , Preliminary Ruling, para. 19. 
23 The following arguments on the identification of  the measure under Article 6.2 of the DSU are 
without prejudice to any substantive debate on the nature of measures under specific provisions of the relevant 
applicable agreements. 
24 WT/DS291/23, page 1; WT/DS292/17, page 1; WT/DS293/17, page 1.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 7 
  
  (b) Speaking of two distinct measures, suspension a nd failure to act, without describing them, the 
requests fail to identify the specific measure at issue 
4.11 Although it is clear that the Requests do not att ack the European Communities' legislation on 
genetically modified products as such, but only its app lication, it is not clear, in what respect the latter 
is being challenged.  All three Requests have in  common that they make an explicit distinction 
between, on the one hand, an allege d "suspension" of the approval process and, on the other hand, an 
alleged "failure" to act. These are presented as separate measures. None of the Requests, however, contains any explanation or descrip tion of what the "suspension" is as opposed to  the "failure" to 
proceed in the approval process.  
4.12 It is, in particular, the reference to an alleged "suspension" that remains entirely in the dark.  
One meaning of "suspension" is "the action  of suspending something."
25  The complaining parties 
may have such an "action" in mind, as might be in ferred from the fact that the US request speaks of 
the European Communities "blo cking" the approval process.26  If this is the case, however, the action 
is not described anywhere.  Is there supposed to be a decision or some other kind of normative or 
executive act, by which the Europ ean Communities has proceeded to "suspend"?  If so, according to 
the above standards, the Requests would at least need  to contain sufficient information to allow – both 
the Panel and the defendant – to effectively identify these acts.  
4.13 "Suspension", on the other hand,  according to the Ox ford Dictionary may also mean "the 
condition  of being suspended".27  The word, then, would describe a state of being, a situation of 
"nothing happening".  If that is what the complaining parties have in mind, it would seem impossible, 
however, to distinguish this "measure" from the alleged inaction, which is that of failing to 
consider/grant approvals. Listing them as two dis tinct measures would not make sense any longer.   
4.14 From the above it can be seen that the Re quests create considerable uncertainty which 
de facto  shifts the burden of identifying the specifi c measure under challenge onto the European 
Communities. If it wants to properly prepare its de fence, the European Co mmunities has no choice 
but to second-guess what the complaining parties mi ght have meant with "suspension" as opposed to 
"failure to act" taking the risk of being presented w ith an entirely different reading at a later stage in 
the proceedings. This situation is irreconcilabl e with the minimum standards of due process as 
exemplified by the WTO case law and fails to comply with the requirement in Article 6.2 to identify 
the specific measures at issue. 
3. The Panel requests do not provide a brief summary of the legal basis of the complaint 
sufficient to present the problem clearly 
4.15 The Requests' lack of sufficient specificity in the identification of the measures at issue is 
coupled with the absence of a brief summary of th e legal basis of the complaint sufficient to present 
the problem clearly, as required by Article 6.2 of the DSU. 
4.16 According to the constant jurisprudence of the Appellate Body, this second requirement in 
Article 6.2 entails that the claims "must all be  specified sufficiently in the request for the 
establishment of a panel in order to allow the defe nding party and any third parties to know the legal 
                                                      
25 The New Shorter Oxford English Dictionary, L. Brown (ed.) (Clarendon Press, 1993), Vol. 2, 
p. 3162. 
26 WT/DS291/23, page 1. 
27 Ibidem. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 8 
  
  basis of the complaint".
28  This allows the defending party to "know what case it has to answer and 
what violations have been alleged so that it can be gin preparing its defence" in a meaningful way, and 
allows it an opportunity to effectively respond to the complaint.29  Furthermore, the panel needs to 
know what claims are raised by the complaining par ties to exercise correctly its jurisdiction since it 
cannot address claims that have not been made.30 
4.17 The significance of this requirement can be better appreciated with regard to the context of 
Article 6.2 of the DSU.  In particular, the European Communities (following the Panel in Canada – 
Wheat Exports and Grain Imports ) notes again the difference in the language between Article 4.4 and 
Article 6.2 of the DSU, that "must be given meani ng" (para. 15). The word "indication" used in the 
former, means "something that indicates or sugg ests and thus conveys the idea of briefness and 
allusion. The word "summary" used by the latter however, comes from the Latin word " summa " and 
covers the idea of something "containing all the ma in points of a matter; dispensing with unnecessary 
detail.  Thus, whilst it is sufficient that a request for consultations mentions  the provisions invoked in 
order to "suggest" what the case could be about, a re quest for the establishment of a panel must be 
detailed enough to cover "all the main points of a matter". 
4.18 In the present case, all three requests limit the illu stration of the legal basis to long lists of 
provisions of the GATT 1994, the SPS Agreement , the TBT Agreement  and the Agreement on 
Agriculture31, without any link being made between the ch allenged measures and the facts of the case.  
In other words, the Requests do not make at all clea r which obligations are alleged to be violated and 
which measures are in violation of which obligations .  This has impaired the European Communities' 
ability to understand what the claims  in the present case are and, thus, to start preparing its defence in 
any meaningful way. 
(a) The mere listing of provisions is not sufficient in this case 
4.19 It is true that the Appellate Body has recognized in EC – Bananas III  that it may be sufficient 
for a complaining party "to list the provisions of the specific agreements alleged to have been violated 
without setting out detailed arguments as to which speci fic aspects of the measures at issue relate to 
which specific provisions of those agreements".32  However, it has added that the question as to 
whether the mere listing meets the standard of Ar ticle 6.2 of the DSU must be examined on case-by-
case basis, taking into account if the ability of the respondent to defend itself was prejudiced by the fact that the panel request simply lists the provisions (Appellate Body Report, Korea – Dairy , 
para. 127).  
4.20 In the same case, the Appellate Body stated that in EC – Bananas III  it did not purport that a 
mere listing of the provisions could always suffice to comply with Article 6.2 of the DSU without 
regard to the particular circumstances of the case ( ibidem , para. 123). In particular, such a listing will 
not satisfy the standard of Article 6.2 if the provisions listed establish not single but multiple 
obligations ( ibidem , para. 124).   
                                                     
 
28 Appellate Body Report, EC – Bananas III , para. 143. 
29 Appellate Body Report, Thailand – H-Beams , para. 88. See also, more recently, Panel Report, 
Canada – Wheat Exports and Grain Imports , Preliminary Ruling, para. 29. 
30 Appellate Body Report, EC – Hormones , para. 156. 
31 WT/DS291/23, page 2; WT/DS292/17, page 2; WT/DS293/17, page 2. 
32 Appellate Body Report, EC – Bananas III , para. 141.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
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  4.21 The Requests indicate as legal basis thirty-eight provisions, several of which contain multiple 
(distinct or parallel) obligations (i.e. Articles 2.2, 2.3, 5.5, 7, 8, and Annex B(5), C(1)(b), of the 
SPS Agreement ; Articles 2.9, 5.2.2, 5.6 and 12 of the TBT Agreement ). 
4.22 Added to the provisions which contain a single obligation, the European Communities is 
faced with alleged violation of th irty-eight different provisions, whic h altogether contain more than 
sixty distinct obligations. Furthermore, several of  those provisions are either mutually exclusive – 
such as those contained in the SPS and in the TBT Agreements
33– or subordinated – such as those of 
the GATT 1994 in relation to the ones contained in the other agreements.34  The panel requests do not 
explain even remotely how the claims would be ar ticulated, for instance, whether all provisions and 
obligations apply simultaneously to different aspects of the measures, or whether some provisions are 
listed only subsidiarily. In front of such an unc oordinated array of provisions and obligations, the 
European Communities has not been able to unde rstand even remotely which are the claims the 
complaining parties intend to pursue. 
(b) No link is made between the provisions listed and the facts of the case 
4.23 The fact that the complaining parties have onl y merely listed the provisions they allege as 
violated, several of which contain multiple obligations, is made worse by the fact that they have also 
failed to make any link whatsoever between these pr ovisions and the facts of the case. Where a panel 
request covers several separate measures, as is the case in the present dispute, it should indicate which 
provisions may be relevant for the examination of  each measure, possibly describing the substantive 
aspects or the effects of the measures which are al legedly in breach of those provisions. The panel 
requests do not provide the slightest explanation in  that regard. Thus, the European Communities is 
completely in the dark also about which provisions would have been violated by which measures, in 
other words about what claims are pursued.  
4.24 Even assuming, in fact, that the complaining par ties intend to allege a violation of each of the 
thirty-eight provisions and of the over sixty obligatio ns listed and that the measures at issue were clear 
– which is not the case –, in order to prepare its  defence the European Communities would still have 
to assess each of the measures indicated against each of  the obligations alleged to have been violated.  
This would result in the preparati on of arguments of defence in case of US request for well over three 
thousands35 hypotheses of different claims. 
4.25 In order to facilitate the task of the Panel in  assessing what is the acceptable standard of 
precision for requests under Article 6.2 of the DSU,  the European Communities points at some recent 
cases36, where the United States, Canada and Argentina were  also complaining parties.  In all of them 
both measures and claims are clearly and precisely specified. 
4. Article 6.2 issues must be decided as early as possible in the proceedings 
4.26 Taking into consideration the double purpose of the requirements of Article 6.2 of the DSU, 
that is defining jurisdiction of the panel and guara nteeing due process, it is evident in the case law that 
                                                      
33 See Article 1.5 of the TBT Agreement  and Article 1.4 of the SPS Agreement . 
34 See the General interpretative note to Annex 1A of  the Marrakech Agreement Establishing the WTO. 
35 Forty-one applications plus nine safeguard measures applied by the member States of the European 
Communities equals a number of fifty measures at issue.   These must then be multiplied by at least sixty 
obligations alleged to have been violated.  The result is over three thousand! 
36 WT/DS295/2 of 22 September 2003; WT/DS277/2 of 4 April 2003; WT/DS268/2 of 4 April 2003 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 10 
  
  it is of the outmost importance that issues arising in regard of these requirements are decided as early 
as possible. 
(a) The Panel has to be able to establish the limits of its jurisdiction 
4.27 If a claim is not properly before a panel, it is  established practice that the panel declines to 
examine it.
37  As the Appellate Body has made clear in sev eral instances, "[t]he vesting of jurisdiction 
in a panel is a fundamental prerequisite fo r lawful panel proceedings" (Appellate Body, Mexico – 
Corn Syrup,  para. 36). 
4.28 Where the request for the establishment of a pane l lacks precision, the panel lacks authority to 
proceed.  It is therefore necessary that, before proc eeding, it first establishes where the limits of its 
jurisdiction are. 
4.29 If, as in the case at issue, the Panel Requests ar e not amended, the scope of the claims which 
are in front of the Panel will remain entirely uncl ear.  Before proceeding, the Panel must know which 
of the three thousands hypotheses of clai ms are the ones actually referred to it. 
(b) The European Communities has been unable to st art preparing its defence in any meaningful 
way 
4.30 Equally, safeguarding the due process rights of the defendant and possible third parties must 
be of central concern to the dispute settlement orga ns.  The defendant in order to prepare its defence 
should know what violations have been alleged a nd what case it has to answ er. The same holds true 
for member States that want to particip ate in the proceedings as third parties.38 
4.31 Where a request for the establishment of a pane l lacks precision, neither the defendant nor 
third parties can adequately prepare their arguments.  A violation of this due process requirement constitutes a fundamental flaw in the proceedings, wh ich must not proceed before the flaw has been 
remedied.   
4.32 In the present case, the lack of specificity of  the identification of the measures at issue, 
coupled with the mere listing of an elevated number of provisions and the absence of co-relation 
between the two, has so far prevented the Europ ean Communities from starting preparing its defence 
in any meaningful way.  The European Communiti es still – to date – does not know the claims that 
the complaining parties intend to bring before the Pa nel.  Taking into consideration the very strict 
deadlines, the European Communities cannot be expect ed to wait for the first written submission of 
the complaining parties to start preparing its defence in a case as sensitive and as important as the 
current one. 
(c) The Panel must scrutinize the request to ensure its compliance with Article 6.2 
4.33 Because of the fundamental nature of the above  requirements in Article 6.2 of the DSU, each 
Panel must be satisfied that its conditions are fu lfilled before assuming jurisdiction over a case.  This 
                                                     
 
37 See, most recently, Panel Report, US – Carbon Steel , paras. 8.11-8.12. 
38 Appellate Body Report, Thailand – H-Beams , para. 88.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 11 
  
  should be done very carefully especially because of the DSB practice consisting of the automatic 
approval of the requests.
39  
4.34 Panels should deal with such issues, the Appellate  Body has ruled, "even if the parties to the 
dispute remain silent on those issues", "if necessa ry, on their own motion, in order to satisfy 
themselves that they have authority to proceed".40  A fortiori  in the present case, where the European 
Communities as the defending party is submitting such  claims to its attention, the Panel must 
scrutinize the Requests to en sure their compliance with Article 6.2 of the DSU. 
(d) The Panel must scrutinize the request as early as possible in panel proceedings 
4.35 In EC – Bananas III , the Appellate Body has also clarified that the claims, which are to be set 
out in the Panel request, must be distinguished fr om the subsequent arguments of the parties in 
support of such claims.  Thus, the former must be sp ecified sufficiently in the request of the panel and 
the latter cannot be used to "cure" a faulty request (para. 143).  
4.36 For this reason the Panel must scrutinize the request to ensure its compliance with Article 6.2 
as early as possible in panel proceedings in order to  avoid causing prejudice or unfairness to any party 
or third party.41 That is also why the European Communiti es is submitting these issues to the Panel at 
the earliest possible juncture in time, i.e. immediately after its composition.42 
5. Request for preliminary ruling 
4.37 For the reasons set out above, the European Co mmunities respectfully requests that the Panel 
issue a preliminary ruling to the effect that the Re quests do not meet the requirements of Article 6.2 of 
the DSU.   
4.38 Since the procedural rules are designed to promote the fair, prompt and effective resolution of 
trade disputes43 and in order to ensure a speedy resolu tion of the present dispute, the European 
Communities would consider it appropriate for the Pa nel to suggest to the complaining parties to 
introduce new panel requests in full compliance with Ar ticle 6.2 of the DSU to be judged by the same 
panel.  The European Communities would like to note that such a course of action has recently been 
taken by a panel in another dispute.44 
B. PRELIMINARY WRITTEN SUBMISSION OF THE UNITED STATES  
1. Introduction 
4.39 The European Communities offers no basis for its request for a preliminary ruling ("EC 
Request") that the US panel request in this dispute fails to meet the requirements of Article 6.2 of the 
DSU.  To the contrary, as required by Article 6.2,  the US panel request properly "identif[ies] the 
                                                      
39 Appellate Body Report, US – Carbon Steel , para. 126, recalling Appellate Body Report, EC – 
Bananas III , para. 142. 
40 Appellate Body Report, Mexico – Corn Syrup (Article 21.5 – US),  para. 36. 
41 Appellate Body Report, EC – Bananas III , para. 144. 
42 Appellate Body Report, Thailand – H Beams , para. 95. 
43 Appellate Body Report, US – FSC , para. 166. 
44 Panel Report, Canada – Wheat Exports and Grain Imports , Preliminary Ruling, para. 65.  In this 
case, the United States indeed introduced a new Panel request (WT/DS276/9), after which the Panel originally 
established continued to exercise its jurisdiction. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 12 
  
  specific measures at issue and provide[s] a brief summa ry of the legal basis of the complaint sufficient 
to present the problem clearly." 
2. The requirements of Article 6.2 of the DSU 
4.40 Article 6.2 of the DSU requires, in relevant part, that a request for the establishment of a 
panel: 
"[I]dentify the specific measures at issue and provide a brief summary of the legal 
basis of the complaint sufficient to present the problem clearly." 
4.41 The EC Request contains a num ber of quotations from Appellate  Body and panel reports, in 
particular from Korea – Dairy
45 and EC– Bananas III46, that explain this provision and emphasize its 
role and importance in dispute settlement.  It has entirely missed, however, one aspect of these reports 
which is critical to the issue now before this Panel:  the key distinction between claims  – which must 
be included in the panel request – and the arguments  in support of those claims – which need not be 
included.  As the Appellate Body explained in EC – Bananas III : 
"In our view, there is a significant difference between the claims  identified in the 
request for the establishment of a panel, which establish the panel's terms of reference under Article 7 of the DSU, and the arguments supporting those claims, which are set 
out and progressively clarified in the first written submissions, the rebuttal submissions and the first and second pa nel meetings with the parties."
47   
4.42 Furthermore, the Appellate Body in EC – Bananas III  made clear that a panel request may 
adequately state a claim if the request simply cites the pertinent provision of the WTO agreement: 
"We accept the Panel's view that it was suffi cient for the complaining parties to list 
the provisions of the specific agreements alleged to have been violated without 
setting out detailed arguments as to which specific aspects of the measures at issue relate to which specific provisions of those agreements."
48  
4.43 The Appellate Body confirmed this reading in Korea – Dairy .  In that dispute, the problem 
with the panel request was that it cited too br oadly to Article XIX of the GATT 1994 and various 
articles of the Agreement on Safeguards , all of which contained numerous  sub-articles, so that it was 
difficult to determine which specific obligations in those provisions were at issue.  The US panel 
request in this dispute, by contrast, cites to speci fic provisions of the WTO agreements at issue, and 
cannot be said to suffer a similar defect.   
4.44 The European Communities also fails to note that even if  a panel request is insufficiently 
detailed "to present the problem clearly," the Panel is  not automatically deprived of jurisdiction over 
the matter.  Rather, the Appellate Body has found th at a panel must examine, based on the "particular 
circumstances of the case," whether the defect has prejudiced the ability of the responding party to 
defend itself.  As the Appellate Body explained in Korea – Dairy:  
                                                      
45 Appellate Body Report, Korea – Dairy . 
46 Appellate Body Report, EC – Bananas III . 
47 Appellate Body Report, EC – Bananas III , para. 141.   
48 Id.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 13 
  
  "In assessing whether the European Communitie s' request met the requirements of 
Article 6.2 of the DSU, we consider that, in view of the particular circumstances of this case and in line with the letter and spirit of Article 6.2, the European 
Communities' request should have been more  detailed.  However, Korea failed to 
demonstrate to us that the mere listing of the articles asserted to have been violated has prejudiced its ability to defend itself in the course of the Panel proceedings.  Korea did assert that it had sustained pr ejudice, but offered no supporting particulars 
in its appellant's submission nor at the oral hearing.  We, therefore, deny Korea's 
appeal relating to the consistency of th e European Communities' request for the 
establishment of a panel with Article 6.2 of the DSU."
49 
4.45 Therefore, in evaluating claims regarding wh ether a panel request "presents the problem 
clearly," a Panel must consider the particular circumstances of the case, including whether the 
defending party has been prejudiced.  
3. The European Communities' assertion that th e US panel request does not identify the 
"specific measures at issue" is incorrect  
4.46 The European Communities appears to have tw o concerns with the identification of the 
measures subject to this dispute.  Neither of these concerns has merit.   
4.47 First, the European Communities cl aims that, "It is, in particul ar, the reference [in the panel 
request] to an alleged 'suspension' that remains entirely in the dark."50  Even without any context, and 
on the plain language of the panel request, it is diffi cult to see how the concept of a "suspension" of 
the consideration and granting of biotech approval s is at all ambiguous.  But in light of well-known 
statements of EC officials acknowledging the existence of a de facto moratorium, the European 
Communities' claim that it is "in the dark" on the meaning of a "suspension" is not credible.   
4.48 Along, these same lines, the European Communities poses the following question: 
"Is there supposed to be a decision or some other kind of normative or executive act, 
perhaps a moratorium legislation of the kind New Zealand had, by which the European Communities has proceeded to 'suspend'?"  
Although the United States is unaware of any single  executive decree or legislative act through which 
the moratorium has been implemente d, such decree or act would be within the scope of the covered 
measures.  Where the European Communities in this dispute denies the existence of a moratorium – a 
moratorium nonetheless acknowledged by its own officials – it cannot in turn try to profit from its 
lack of transparency by arguing that the complaini ng parties have not identified the moratorium with 
sufficient specificity.    4.49 Second, the European Communities claims that th e US panel request is fatally flawed because 
it uses both the phrase "a suspension of consideration"  and "a failure to consider".  The European 
Communities does not explain why these two different  wordings introduce any ambiguity concerning 
the measures subject to the request.  Moreover, in  the context of the panel request, the reason for 
using these two different wordings is quite clear.   
                                                     
 
49 Id., para. 131.   
50 EC request, para. 22.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 14 
  
  4.50 The first phrase – suspension of considera tion – is used to describe the European 
Communities' across-the-board moratorium affecting all biotech products:  
"(1) as described above, the suspen sion by the European Communities of 
consideration of applications for, or gran ting of, approval of biotech products."   
The second phrase – failure to consider – is used to describe the European Communities' conduct as it 
affects the specific products identified in the annexes to the panel request:  
"(2) as described above, the failure by th e European Communities to consider for 
approval applications for the biotech products  mentioned in Annexes I and II to this 
request." 
These are simply two different wordings for the sa me concept -- the word "s uspension" fits better 
with the European Communities' conduct as it aff ects all biotech applications, while the phrase 
"failure to consider" fits better with specific applications.  Th e European Communities does not and 
cannot explain how these different wordings amount to  a failure to identify the specific measures at 
issue.   4.51 For the above reasons, the European Communiti es has presented no reason for finding that the 
US panel request does not meet the requirement of  Article 6.2 to identify the specific measures at 
issue. 
4. Contrary to the European Communities' a llegations, the US panel request provides a 
brief summary of the legal basis of the complaint sufficient to present the problem clearly 
4.52 The US panel request, which lists the specific provisions of the SPS Agreement , 
TBT Agreement , Agreement on Agriculture , and GATT 1994 alleged to be violated, provides a brief 
summary of the legal basis of the complaint suffici ent to present the problem clearly, as required by 
Article 6.2.   
4.53 The Appellate Body has made clear on several occasions that a panel request may adequately 
summarize the legal basis of the complaint under Artic le 6.2 by simply citing the pertinent provisions 
of the WTO Agreement.
51  The European Communities cites Korea – Dairy , in which the Appellate 
Body stated that there may be ci rcumstances in which a "listing of treaty articles would not satisfy the 
standard of Article 6.2."52  But in that proceeding the articles cited had multiple pa ragraphs, many of 
which had their own distinct obligations: for inst ance, the panel request cited Article XIX of the 
GATT 1994, containing three sections and five paragraphs, each with at  least one distinct obligation, 
and Article 12 of the Agreement on Safeguards , which spans two pages and contains 11 paragraphs.53   
4.54 By contrast, the US panel request in this  dispute lists specific provisions of the 
SPS Agreement , TBT Agreement , Agreement on Agriculture , and the GATT 1994.  Where an article 
consisted of more than one para graph, the US panel request specifically identified the particular 
paragraph number.  Moreover, wher e a paragraph has subparagraphs, in most cases the panel request 
                                                      
51 E.g., Appellate Body Report,  EC – Banana s III, para. 141;  Appellate Body Report,  Korea – Dairy , 
para. 124. 
52 Appellate Body Report,  Korea – Dairy , para. 124. 
53 Id.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 15 
  
  goes on to specify the specific subparagraphs.
54  Unlike in the case of  Korea – Dairy , there are no 
circumstances in this dispute that would render c itation to the relevant specific provision of the WTO 
agreement insufficient under Article 6.2. 
4.55 Previous panels and the Appellate Body have been very careful to distinguish between the 
claims that must be made in a panel request under Article 6.2 -- i.e., the brief summary of the legal 
basis  for the complaint sufficient to present the problem clearly -- and the arguments  supporting those 
claims.  The claims must be set forth in the pane l request.  The arguments do not.  As the Appellate 
Body stated in EC – Bananas III :  
"We accept the Panel's view that it was suffi cient for the complaining parties to list 
the provisions of the specific agreements alleged to have been violated without 
setting out detailed arguments as to which specific aspects of the measures at issue relate to which specific provisions of tho se agreements.  In our view, there is a 
significant difference between the claims  identified in the request for the 
establishment of a panel, which establis h the panel's terms of reference under 
Article 7 of the DSU, and the arguments supporting those claims, which are set out 
and progressively clarified in the first written submissions, the rebuttal submissions and the first and second panel m eetings with the parties."
55   
4.56 In this dispute, the European Communities is not faulting the United States for failing to set 
out the legal basis  for the complaint.  It is faulting the United States, incorrectly, for not including its 
arguments  in support of that basis.   
4.57 The European Communities presents two lines of  argument why in this case the US panel 
request must have gone beyond listing the claims, to  also include the arguments in support of those 
claims.  
4.58 First, the European Communities counts up the number of provisions listed by the United 
States, and proposes that this number is somehow too high to be covered by the provision actually 
found in the text of the DSU, namely that a pane l request that specifies the claims is in compliance 
with Article 6.2 of the DSU.   
4.59 As an initial matter, the United States notes that it does not agree with the European 
Communities' count of the number of obligations cove red in the US panel request.  For example, the 
European Communities argues that Article 7 of the SPS Agreement  includes two separate obligations.  
The second Article 7 obligation, however, is to co mply with the obligations in Annex B of the 
SPS Agreement , and the US panel request specifies the sp ecific provisions of Annex B alleged to be 
violated.  Accordingly, the European Communiti es engages in double-counting by counting both the 
general obligation to comply with Annex B, and al so the specific provisions of Annex B listed in the 
US panel request.  
4.60 Moreover, the simple reason that the US panel re quest covers a number of  obligations is that 
the European Communities' decision to adopt, without transparency, a de facto moratorium on the 
approvals of important agricultural products understandably results in a violation of several provisions 
                                                      
54 The only exceptions are Annex B(5) of the SPS Agreement , and Articles 2.9 and 5.6 of the 
TBT Agreement , each of which contain four subparagraphs estab lishing related transparency obligations.  The 
specific subparagraphs were not identified because th e United States considers the EC measures to be 
inconsistent with each one.   
55 Appellate Body Report,  EC – Bananas III , para. 141.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 16 
  
  of the WTO Agreement.  Article 6.2 of the DSU does not impose an entirely different standard on a 
panel request on the basis that the defending part y has engaged in multiple violations of the WTO 
Agreement.   
4.61 In addition, other than pointing to the number of obligations covered by the US panel request, 
the European Communities does not explain how it is confused, or in any way prejudiced, by the 
panel request.  Surely, the European Communities cannot claim, for example, that it fails to 
understand (and thus is unable to begin to defend itself against)  the proposition that a general 
moratorium on the approval of biotech products might violate the obligation in Article 5.1 of the 
SPS Agreement  that SPS measures must be based on risk assessments.  Nor, for example, can the 
European Communities claim not to understand (and t hus not to be able to begin to defend itself 
against) the proposition that a 5-year moratorium would be inconsistent with the requirement in 
Annex C(1)(a) of the SPS Agreement  to undertake and complete procedures to ensure the fulfilment of 
SPS measures "without undue delay." 
4.62 Finally, the European Communities itself acknow ledges that "several of those provisions 
[cited in the panel requests] are either mutua lly exclusive – such as those contained in the 
SPS Agreement  and  the TBT Agreement  – or subordinated – such as those of the GATT 1994 in 
relation to the ones contained in the other agreements."
56  In the consultations and at the meetings of 
the DSB, the United States has made clear that it considers the moratorium to be an SPS measure.  
The European Communities, however, has refuse d to even acknowledge the existence of the 
moratorium, much less to acknowledge that th e moratorium falls within the scope of the 
SPS Agreement .  It is for this reason that the complaining parties in their panel requests have been 
required to cite both SPS provisions and the corresponding provisions of the TBT Agreement .  In these 
circumstances, it is difficult to understand how th e European Communities could claim any confusion 
or prejudice from citing provisions of both the SPS Agreement  and TBT Agreement .   
4.63 Second , the European Communities suggests that th e "common practice" is for panel requests 
to go beyond stating the claims to laying out the arguments in support of those claims.  The European 
Communities does not, however, even begin to expl ain how a "practice" could alter the textual 
requirements of Article 6.2 of the DSU, nor does it attempt to reconcile its suggestion with the fact 
that the panel request in EC – Bananas III57 (which the Appellate Body considered to have been 
consistent with Article 6.2) did not set out the complaining parties' arguments in support of their 
claims.  Furthermore, the European Communities gives no real basis for its assertion of a "practice"; it 
mentions exactly three panel requests, when in  fact, as of 31 October 2003, there had been 119 panels 
established.58  Certainly, citation to panel requests in  such a tiny fraction of cases would not be 
sufficient to establish a "practice" of any kind.59 
4.64 In short, the European Communities has not pr esented any reasons why the US panel request, 
which clearly specifies the claims in this dispute,  should be found inconsiste nt with the requirements 
of Article 6.2 of the DSU.  
                                                      
56 EC Request, para. 40. 
57 WT/DS27/6. 
58 Statistical Information on Recourse to WTO Dispute Settlement Procedures (1 January 1995 – 
31 October 2003):  Background Note by the Secretariat , Job(03)/225, circulated 11 December 2003, part III(A). 
59 The United States notes that the European Communities has in any event not followed any such 
"practice" itself; see, e.g. , the panel request in US – 1916 Act , WT/DS136/2, in which the European 
Communities did nothing more than provide citations to , and cursory paraphrases of, provisions of the WTO 
Agreement.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 17 
  
  5. The US panel request does not prejudice the ability of the European Communities to 
defend itself 
4.65 In Korea – Dairy , the Appellate Body denied Korea's Article 6.2 claim in toto  because, 
although it had asserted prejudice, Korea offered no supporting particulars.
60  The European 
Communities does assert that it is prejudiced by the US panel request, but only in the vaguest and 
most conclusory manner.   
4.66 The European Communities' only explana tion of its alleged prejudice is that: 
"[T]he lack of specificity of the identifica tion of the measures at issue, coupled with 
the mere listing of an elevated number of  provisions and the absence of co-relation 
between the two, has so far prevented the European Communities from starting 
preparing its defence in any meaningful way."61   
4.67 This argument, however, is nothing more than  a restatement of its argument, refuted above, 
that the request is insufficiently detailed with respect to actual arguments to support the legal basis of 
the complaint.  In light of the Appellate Body's reasoning in Korea – Dairy , such a mere restatement 
is plainly insufficient to establish prejudice.  If lack  of detail in the panel request automatically meant 
"prejudice," there would be no need for a "prejudice" analysis.   
4.68 Moreover, the United States finds it hard to accept that the European  Communities has not 
already begun to "prepare its defence in a meani ngful way."  To be specific, is the European 
Communities arguing that it has not already begun to develop explanations of why it denies the 
existence of a moratorium despite the statements of EC officials to the contrary; of why no new 
biotech products have been appr oved for over 5 years if there has been no moratorium; and of how 
such a moratorium is consistent with the substantiv e, procedural and transparency obligations of the 
SPS Agreement ?  The European Communities in its ruling request does not make such claims, and, 
indeed, could not credibly do so.   
4.69 Accordingly, even if the Eur opean Communities had succeeded in demonstrating that the US 
panel request does not meet the requirements of Article 6.2 of the DSU, which it has not, the 
European Communities has offered nothing to suggest that it has been prejudiced.   
6. The European Communities failed to raise it s Article 6.2 concerns at the earliest 
possible opportunity 
4.70 Finally, the European Communities fails to re cognize that procedural objections must be 
raised at the earliest possi ble opportunity, and not for the first time in a ruling request filed after the 
composition of the panel.62  In the US – FSC  dispute, the United States requested a preliminary ruling 
that a claim be dismissed because of an inadequacy  in the consultation request.  The panel rejected 
that request, and the Appellate Body  upheld that rejection, stating, 
"It seems to us that, by engaging in consultations on three separate occasions, and not 
even raising objections in the DSB meetings  at which the request for establishment of 
a panel was on the agenda, the United States acted as if it had accepted the establishment of the panel in this dispute,  as well as the consultations preceding such 
                                                     
 
60 Appellate Body Report,  Korea – Dairy , para. 131. 
61 EC Request, para. 50.   
62 Appellate Body Report, US – FSC , para. 165. WT/DS291/R 
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  establishment.  In the circumstances, the United States cannot now, in our view, 
assert that the European Communities' cl aims ... should have been dismissed."
63 
4.71 Likewise, at no time prior to the composition of this Panel did the European Communities so 
much as intimate that it considered the panel request  in any way deficient, waiting until after the panel 
was composed to offer its objection.  In upholdi ng the panel's rejection of the US request for a 
preliminary ruling in US – FSC  under very similar circumstances, the Appellate Body stated, "The 
procedural rules of the WTO dispute settlement system are designed to promote, not the development of litigation techniques, but simply the fair, prom pt and effective resolution of trade disputes."
64  This 
Panel should reject the European Communities' e ffort to avoid the fair, prompt and effective 
resolution of this dispute through its groundless – an d untimely – objections to the US panel request.  
C. PRELIMINARY WRITTEN SUBMISSION OF CANADA  
1. Introduction 
4.72 Canada's panel request properly "identif[ies] th e specific measures at issue and provide[s] a 
brief summary of the legal basis of the complaint sufficient to present the problem clearly."  Not only 
has Canada adequately identified and described th e specific measures, the European Communities has 
no justification for professing any surprise or conf usion as to the nature of these measures.  The 
European Communities is really asking this Panel to require Canada to identify, not the specific 
measures, but the specific evidence that Canada  intends to raise in this proceeding.   
4.73 The European Communities is also asking this Pa nel to read into Article 6.2 a requirement 
that is not there and that the Appellate Body ha s specifically rejected, namely, that Canada is 
obligated to summarize specific legal arguments to be presented in its first written submission.  The 
Appellate Body has already rejected this approach, and this Panel should do so as well.  Furthermore, 
not only does the European Communities misrepresent the extent of the complexity of the provisions 
cited by Canada in its panel request, the Europ ean Communities also attempts to import from the 
Anti-Dumping Agreement a standard into Article 6.2 that is not supported by the text of that provision. 
4.74 Lastly, the European Communities does not provi de any evidence or rationale to support a 
claim that it has been prejudiced in any way by Canada's panel re quest.  The European Communities 
is fully aware of the matters referenced in Canada's  panel request, and has had ample time to begin to 
prepare a defence.  If it has failed to do so, the causes  of that failure cannot be  found in Canada's panel 
request. 
4.75 In sum, the EC Request is without merit.  It appears to be nothing more than the kind of 
"litigation technique" that the Appellate Body firmly rejected in US – FSC . 
2. Requirements of Article 6.2 of the DSU 
4.76 The EC Request contains a number of quotations  from Appellate Body and panel reports that 
explain Article 6.2 and emphasize its role and importa nce in dispute settlement.  However, it fails to 
reflect one aspect which is critical to the issues be fore this Panel:  the key distinction between the 
claims – which must be included in the panel request  – and the arguments in support of those claims – 
which need not be included.  
                                                      
63 Id. 
64 Id., para. 166.  WT/DS291/R 
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  4.77 Furthermore, with respect to the requirement for a panel request to provide a "brief summary 
of the legal basis of the complaint," the Appellate Bo dy has made it clear that it may be sufficient for 
the purposes of Article 6.2 for a panel request to simply cite the pertinent provision of the WTO 
agreement.  The Appellate Body has also made it clear that whether such a listing is sufficient  will 
depend on the circumstances of each case.  
4.78 Finally, the jurisprudence has established that , even where a panel request does not "present 
the problem clearly," the panel is not automatically deprived of jurisdiction over the matter.  Rather, 
the panel must examine, based on the "particular ci rcumstances of the case," whether the defect has 
prejudiced the ability of the responding party to defend itself. 
4.79 Therefore, in evaluating claims as to whether a panel request presents the problem clearly, the 
Panel must consider the particular circumstances of the dispute, including whether the responding 
party has been prejudiced.  
3. Canada's Panel request identifies the "sp ecific measure at issue" as required by 
Article 6.2 of the DSU 
4.80 As set out in Canada's panel request, the specific measures at issue are: 
"[T]he general suspension by the EC of its own processes for th e consideration of 
applications for, and the granting of, approval for biotech products; 
the failure by the EC to consider or appr ove, without undue dela y, applications for 
approval of the products id entified in Annex I; and 
the national measures identified in Annex II pr ohibiting the importation, marketing or 
sale of the specified EC-approved biotech products." 
4.81 Because the European Communities has not asserted a failure on the part of Canada to 
identify with sufficient precision the second and thir d categories of measures lis ted in Canada's panel 
request, Canada assumes that the European Comm unities does not dispute that these measures have 
been identified with sufficient precision. 
(a) The moratorium is identified with sufficient precision 
4.82 The reference to "the general suspension by th e EC of its own processes for the consideration 
of applications for, and the granting of, approva l for biotech products" (hereinafter "moratorium") 
should be read in conjuncti on with the second paragraph of Canada's panel request .  In that paragraph, 
Canada states that since October 1998, the Europ ean Communities has maintained a moratorium on 
the approval of biotech products.  It is clear that the phrase "the general suspension by the EC of its 
own processes for consideration of applications for, and the granting of, approval for biotech 
products" is a more detailed description of the "morat orium" to which Canada earlier refers.  Canada 
clearly identifies the relevant approval legislation fo r biotech products in footnote 1 to Canada's panel 
request.   
4.83 In addition, Canada's panel request sets out speci fic examples of applications for approval of 
biotech products, including a brief description of the actions taken to block their consideration or 
approval.  The repeated failures by the Europ ean Communities to consider or approve these 
applications are both cited as examples of the mo ratorium (in the second paragraph of the panel 
request) and as separate measures covered by the pa nel request.  Thus, the phrase "general suspension WT/DS291/R 
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  by the EC of its own processes for consideration of applications for, and th e granting of, approval for 
biotech products" when read in the light of the second paragraph of the panel request, sufficiently 
identifies the "specific measure at issue."   
4.84 The assertion by the European Communities that it is unable to identify the precise measure at 
issue is difficult to understand.  The existence of the moratorium has been widely recognized and 
discussed by EC officials since the Declaration by five EC member States at the 2194
th Council 
Meeting of EC Environment Ministers in June 1999. 
4.85 Numerous EC officials, including Commissi oners Wallström and Byrne, have publicly 
acknowledged the existence of the moratorium.  Moreover, as the European Communities is well 
aware, no biotech products have b een approved under the relevant EC  legislation since October 1998.  
Thus, it is disingenuous for the European Communiti es to claim to be unable to identify the measure 
at issue. 
4.86 What the European Communities is  really seeking in its request is pre-submission discovery 
of the evidence that Canada will adduce in its firs t written submission.  However, under Article 6.2, 
there is no requirement that a complaining party mu st set out the evidence that will be adduced to 
support the measure or the claims made in the panel request.   
4.87 Canada agrees that what can be consider ed a "specific measure" will depend on the 
circumstances of the particular case, including th e characteristics of the measure in question.  
4.88 Unlike measures typically at issue in WTO di spute settlement, the moratorium has neither 
been formally adopted nor published promptly as required by Annex B of the SPS Agreement  and 
Article X:1 of the GATT 1994.  Had the European Communities adopted the mo ratorium as a formal 
legal measure and complied with the transparency requirements of the SPS Agreement  and the GATT 
1994, Canada would have been in a position to iden tify the particulars suggested by the European 
Communities in paragraph 22 of its Request.  It is  only because of the European Communities' own 
lack of transparency that Canada cannot prov ide the information the European Communities is 
demanding.  The European Communities should not be able to use its own lack of transparency as a 
shield against a WTO challenge. 
4. Canada's panel request provides "a brief su mmary of the legal basis of the complaint 
sufficient to present the problem clearly" as required by Article 6.2 
(a) In view of the circumstances surrounding this cas e, Canada's listing of the relevant provisions 
complies with the requirements of Article 6.2 
4.89 Whether merely listing the provisions of the specifi c agreements alleged to have been violated 
is sufficient for the purposes of Article 6.2 must  be decided on a case-by-case basis, taking into 
account all of the circumstances surrounding that case.  In  the circumstances of this case, the listing of 
the treaty provisions alleged to have been viol ated is sufficient to present the problem clearly. 
4.90 First, from the standpoint of the so-called multiplicity of the listed obligations, the EC 
Request recognizes that the majority of the provisi ons listed by Canada cont ain single obligations.  
While some of the provisions contain more than one obligation, this fact alone does not preclude their 
simple listing from being sufficient to present the problem clearly. 
4.91 For instance, the European Comm unities notes that Canada has ma de claims with respect to 
paragraph 5 of Annex B of the SPS Agreement , and Articles 2.9 and 5.6 of the TBT Agreement .   WT/DS291/R 
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  According to the European Comm unities these three provisions contain twelve separate obligations 
altogether.  However, a review of these provisions makes it clear that they reflect essentially the same four obligations albeit being imposed in three differe nt contexts.  The same holds true for the five 
obligations the European Commun ities alleges are found in paragr aph 1(b) of Annex C of the 
SPS Agreement  and Article 5.2.2 of the TBT Agreement .  When one considers that the SPS Agreement  
and the TBT Agreement  are alternative agreements the true nature of the burden placed upon the 
European Communities to understand Canada's claims  is significantly lighter than the European 
Communities would have the Panel believe. 
4.92 Furthermore, the European Communities notes that Article 2.2 of the SPS Agreement  contains 
three distinct obligations.  While this may be tr ue, the European Communities fails to mention that, 
according to the jurisprudence, the three obligations  found in Article 2.2 are more general expressions 
of the obligations found in Articles 5.1, 5.2 and 5.6 of the SPS Agreement .
  Thus, claims raised with 
respect to these three articles are essentially the same claims as those raised with respect to 
Article 2.2.  The same holds true for Articles 2. 3 and 5.5.  Surprisingly, the European Communities 
appears to have the impression that Canada is ma king a claim with respect to the obligation in 
Article 5.5 to cooperate in the de velopment of guidelines with respect  to the practical implementation 
of that article.  There is nothing in the descrip tion of the measures in Canada's panel request to 
suggest that this is part of Canada's claim. 
4.93 The European Communities also lists Articles 7 and 8 of the SPS Agreement as containing 
multiple obligations.  A review of these two provi sions makes it clear, however, that they simply 
establish general obligations on the WTO Members to meet the specific requirements of Annexes B and C.  The fact that Canada's panel request specifi cally mentions paragraphs 1, 2 and 5 of Annex B, 
and paragraphs 1(a), 1(b), 1(c), a nd 1(e), of Annex C, makes it clear that the inclusion of Articles 7 
and 8 cannot be taken to mean that Canada is clai ming a general violation of Annexes B and C.  If 
that were the case, Canada's specific referen ces to the listed paragra phs would be redundant. 
4.94 In sum, there is nothing in the DSU or th e jurisprudence to suggest that listing many 
provisions necessarily requires any more detail than listing relatively few provisions.  Also, the European Communities' complaint about being faced  by multiple obligations does not stand up to 
closer scrutiny, or provide support for its claim th at Canada's panel request does not provide a brief 
summary of the legal basis of the complain t sufficient to present the problem clearly. 
(b) Canada's panel request establishes an adequa te link between the provisions listed and the 
measures at issue, consistent with Article 6.2 
4.95 There is no requirement in the DSU that a panel request draw a link between the legal 
obligations at issue and "the facts of the case".  Ra ther, the obligation in Article 6.2 is to identify the 
specific measures at issue and provide a brief summary of the legal basis.
  This is precisely what 
Canada's panel request does. 
4.96 First, Canada's panel request states, after describing the measures at issue, that "[t]hese 
measures are inconsistent with the obligations of the EC" under four specific agreements, and  
specifies which provisions of those agreements are be ing violated.  Canada has met the requirement to 
clearly identify the specific measures.  The subseque nt listing of the specific provisions being violated 
must be read in the overall context of the panel request.  Some provisions are obviously relevant to 
some claims, and just as obviously irrelevant to other claims.  Finally, because the SPS and 
TBT Agreements are mutually exclusive, it should be clear that the provisions of the TBT Agreement  
are listed in the alternative. WT/DS291/R 
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  4.97 Second, it is inappropriate for the European Co mmunities to challenge Canada's panel request 
on the basis of the alleged complexity of the thr ee panel requests taken as a whole.  Each panel 
request must be evaluated on its own merits in light  of the requirements of Article 6.2.  Canada's 
request is clear, specific and provides adequate  information for the European Communities to 
understand the nature of the measures at issue and th e legal basis for the complaint.  The European 
Communities' reference to a multiplicity of provisions and legal obligations, and to 41 applications for 
approval of biotech products and nine EC member State national measures, misleads the Panel as to 
the actual scope of Canada's panel request.  However,  even if it were appropriate for the adequacy of 
the three panel requests to be judged as a whole under Article 6.2, the three panel requests all meet the 
standard of that provision. 
4.98 Third, in examining the adequacy of Canada 's panel request, the Panel should also have 
regard to other "attendant circumstances," such as th e long history of bilateral consultations between 
Canada and the European Communities, and the lengthy  list of questions submitted by Canada to the 
European Communities in advance of the WTO cons ultations held on 25 June 2003.  When these 
numerous communications are taken into account, it quickly becomes clear that the European 
Communities has been apprised of the nature of this dispute, and of the allegations by Canada in its 
panel request, well before the pa nel was established on 29 August 2003. 
4.99 Finally, the European Communities provides three recent panel requests filed by the 
complaining parties in other WTO disputes, and offe rs these as a means to "facilitate the task of the 
Panel in assessing what is the acceptable standard of precision for requests under Article 6.2."
  
However, the European Communities fails to indicate th at the three panel requests were all made in an 
anti-dumping context.  The Appellate Body has pointe d out that Article 6.2 and Article 17.5 of the 
Anti-Dumping Agreement  are complementary, and that Article 17.5 contains "additional 
requirements."  Specifically, the Appellate Body f ound that "[a] panel request made concerning a 
dispute brought under the Anti-Dumping Agreement  must therefore comply with the relevant dispute 
settlement provisions of both that Agreement and the DSU." 
4.100  To suggest that the Panel rely on these panel re quests as the standard against which to judge 
the adequacy of Canada's panel request, is inappr opriate.  The three panel requests cited by the 
European Communities are simply irrelevant to a determination of the "acceptable standard of 
precision" for requests made under Article 6.2 alone. 
(c) Article 6.2 does not require a complaining party to  include a summary of its legal argument in 
its request to establish a panel 
4.101  In stating that Canada's panel request "should indicate which provisions may be relevant for 
the examination of each measure, possibly describi ng the substantive aspects or the effects of the 
measures which are allegedly in breach of those provisions," the European Communities is actually 
complaining that Canada has not indicated what le gal arguments it intends to pursue.  According to 
the jurisprudence, there is no requirement to set ou t legal arguments in a panel request.  The European 
Communities' arguments in this regard are clear ly without merit and should be rejected.   
5. Canada's panel request does not prejudice th e ability of the European Communities to 
defend itself 
4.102  Whether a responding party has suffered prejudice is a relevant consideration in determining 
if a panel request has met the requirements of Ar ticle 6.2.  A responding party must demonstrate 
prejudice with "supporting particulars".  WT/DS291/R 
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  4.103  The European Communities does not offer any valid  supporting particulars to justify a finding 
of prejudice.  It appears that the European Commun ities is claiming prejudice on the basis that it "has 
been unable to start preparing its case in a meaningful way."  In support of this assertion, the 
European Communities merely restates its arguments,  refuted above, regarding the lack of specificity 
in the identification of the measures at issue and the multiplicity of claims being made.  Such a mere 
restatement is plainly insufficient to establish prej udice.  If lack of detail in the panel request 
automatically implied "prejudice," there would be no n eed for a separate "prejudice" analysis.  Even if 
the European Communities could show that Canada's  panel request does not meet the requirements of 
Article 6.2, it has offered nothing to show that it has been prejudiced. 
4.104  Even if the European Communities' assertion th at it "has been unable to start preparing its 
defence in any meaningful way" is true, which is highly doubtful, it has nothing to do with the lack of specificity in the identification of the measures at i ssue or the absence of a brief summary of the legal 
basis for the claims.  Given that this pane l was established in August 2003, the European 
Communities has had more than enough time to begin preparing its case.  The consequences of its 
alleged failure to do so should be borne the Eur opean Communities, not by the complaining parties. 
4.105  In particular, the European Communities has not  provided any explanation for why it waited 
almost seven months since the filing of Canada's pa nel request to raise its concerns regarding claimed 
procedural deficiencies.  This delay by the Europ ean Communities runs counter to the statements by 
the Appellate Body that responding Members must promptly bring claimed procedural deficiencies to 
the attention of the complaining Member, and to the DSB or the Panel, and that the procedural rules 
of WTO dispute settlement are designed to promote,  not the development of litigation techniques, but 
the fair, prompt and effective resolution of trade disputes. 
4.106  In light of this delay and the absence of an y explanation for the delay, the European 
Communities' claim that it has suffered prejudice lacks cr edibility.  Canada submits that this request is 
merely a litigation technique intended to undermine th e fair, prompt and effective resolution of this 
dispute. 
D. P
RELIMINARY WRITTEN SUBMISSION OF ARGENTINA  
1. Introduction 
4.107  The European Communities claims that the requ est for the establishment of the panel did not 
present the legal basis of the complaint in a mann er sufficiently clear to enable the European 
Communitieis to fully identify the specific measure at  issue and to fully understand the legal basis of 
the complaint.  Argentina will address these two cl aims on the basis of the textual obligations of 
Article 6.2, taking into account the general due process considerations related to the specific 
requirements of the article. 
2. Object and purpose of Article 6.2 
4.108  The main purpose of Article 6.2, as has been r ecognized by WTO jurisprudence, is directly 
related to the jurisdiction of a pa nel and due process considerations.65  The process to assess the 
fulfilment of Article 6.2 requirement should be undertaken by a Panel on a case by case basis , in the 
light of the attendant particular circumstances  and assessing the prejudice  issue which remains at the 
heart of the due process consideration. 
                                                      
65 See Appellate Body Report, EC – Bananas III , para. 142. WT/DS291/R 
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  4.109  Due process  requirements as previously defined by  panels and the Appellate Body, are 
relevant for all parties in the dispute, including complaining parties.  The Panel must consider the 
impact on the rights of Argentina and other compla ining parties of an overly strict, formalistic 
interpretation of Article 6.2 as comp ared to a textual interpretation. 
3. The European Communities' claim regarding partial lack of identification of the 
measure at issue 
4.110  The European Communities' request  on this point is limited to the claim of suspension of 
consideration of and failure to consid er various applications for approval of  agricultural biotech 
products, as presented in point (1) of the fi rst page of Argentina's Panel request.
66  The European 
Communities has conceded that it has no prelimin ary objection related to the claims on national 
marketing and import bans and has put forward no argument related to Argentina's claim of undue 
delays in finalizing considerati on of various applications for a pproval of agricultural biotechnology 
products. 67  
4.111  The need to analyse the Panel request in its entirety has been  expressly recognized in the 
recent Panel report on Canada – Wheat Exports and Grain Imports.  Reading the Panel request as a 
whole, it is apparent that the measure the European  Communities claims is incompletely identified has 
been preceded by the fourth paragraph of  Argentina's Panel request, which states: 
"This action taken by the European Communities  and some of its member States 
adversely affects agricultural biotechnology products from Argentina"68 
4.112  This general and introductory paragraph refers to the action undertaken by the European 
Communities which Argentina is challenging in these pr oceedings.  The relevant question at this point 
of the analysis is:which action by the European Co mmunities led to the measure at issue?  The answer 
may be found easily by referring to the sec ond paragraph of Argentina's Panel request: 
"The European Communities has applied a de facto moratorium  on the approval of 
agricultural biotechnology products since Oc tober 1998.  This de facto moratorium69 
has led to the suspension of and failu re to consider various applications  for approval 
of agricultural biotechnology products as well as to undue delays in finalizing the processing of applications for the appr oval of such products under Community 
legislation.
70"71 
4.113  The de facto moratorium is the acti on constituting a conduct of suspension  of consideration or 
failure  to consider.  The de facto  moratorium is an omission attri buted to the European Communities 
                                                      
66 WT/DS293/17. 
67 See footnote 14 on EC request for preliminary ruling. 
68 WT/DS293/17, English version, paragraph fourth, page 1. 
69 WT/DS293/17, footnote 1: "1.See Annex I".  
70 (footnote original) Ibid., footnote 2: "EC legislation on biotech product approval includes 
Directive 2001/18/EC  of the European Parliament and of the Council of 12 March 2001, published in Official 
Journal No. 106 of 17 Ap ril 2001, pages 0001-0039 (and its pr edecessor Council Di rective 90/220/EEC  of 23 
April 1990, published in Official Journal No. 117 of 8 May 1990 and amended by Directive 94/15 , published in 
Official Journal No. 103 of 22 April 1994, and by Directive 97/35, published in Official Journal No. 169 of 27 
June 1997), and Regulation (EC) No. 258/1997  of the European Parliament and of the Council of 27 January 
1997, published in Official Journal No. 043 of 14 February 1997." 
71 WT/DS293/17, p. 1, 2nd para.  WT/DS291/R 
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  which amounts to a breach of its obligations under WTO law.
72  According to the dictionary, de facto  
means "in fact, in reality in actual existence…whether by right or not".73  The word de facto  qualifies 
moratorium  which is at the heart of this dispute.  Moratorium,  according to a textual approach, means 
"a postponement or deliberate suspension of some activity".74  The action to suspend may be easily 
understood by reading the subject of the suspension in the same paragraph, i.e. the link to various 
applications  for approval of agricultural biotechnology products .  The nature and extent of the legal 
argument related to the suspension, as well as the speci ficity of the suspension in relation to specific 
applications, is something to be developed as part of the argument. 
4.114  Equally, the failure ("omission to do"75) to consider various applications  for approval  is not 
difficult to understand.  There are applications submitted for approval which are subject to the 
de facto moratorium . 
4.115  The universe of the applications and the factual circumstances surrounding each of them, as 
well as the fact that specific applications cited by  individual complaining parties may lead to different 
arguments during the Panel proceedings, is not a matter to be dealt with in a panel request or a request 
for a preliminary ruling. 
4.116  It should be noted that the status of various applications is a matter discussed at length during 
the consultations.  The European Communities cannot  ignore now the kind of inquiry undertaken 
during the consultations, which led to the current wording in the panel request. 
4.117  The European Communties further alleges that in  other proceedings before the DSB, not only 
Argentina but the other complaining parties have b een able to identify the matter at issue with a 
precision that, in the view of the European Commu nities, is absent in the case at hand.  Argentina 
respectfully suggests that the Panel consider the follo wing circumstances.  First, Argentina is not in a 
position to comment on the cases cited as examples by the European Comm unities for the alleged 
deficiencies in the US and Canada panel requests.   Second, Argentina notes that the three cases cited 
as examples were dumping cases, a subject which is governed by the specific provisions of the Anti-
Dumping Agreement  which contains rules that qualify the provisions of Article 6.2 of the DSU. Also, 
the very nature of the measures subject to challe nge is different in each circumstance – duly enacted 
national provisions regulati ng the conduct of formal proceeding in the case of the Anti-Dumping 
Agreement  on the one hand and an informal de facto moratorium on the application of national 
provisions on the other hand. 
4.118  At this stage, it should be said that the alleged problem with the measure at issue is an attempt 
by the European Communities to request the develo pment of a factual description of the moratorium 
which rightly pertains to the development of ar guments and the fact-finding process.  This attempt 
should be firmly rejected by the Panel, particularly  taking into account the nature of the measure at 
issue.  The type of measure at issue, the  de facto moratorium  leading to suspension or failure to 
consider applications, necessarily affects the extent  and nature of informa tion required to properly 
present the claim.   
4.119  The request of Argentina singles out specifi c applications.  Whether the totality of 
applications are at stage of suspension (i.e. have been considered and are now suffering a delay), or 
                                                      
72 See Appellate Body Report, US – Corrosion-Resistant Steel Sunset Review,  para. 88. 
73 The New Shorter Oxford English Dictionary , 1993 Edition, page 615. 
74 The New Shorter Oxford English Dictionary , 1993 Edition, page 1829. 
75 The New Shorter Oxford English Dictionary , 1993 Edition, page 907. WT/DS291/R 
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  alternatively were submitted but there is a failure to consider them, is an issue to be defined in the 
proceedings. 
4. The alleged lack of brief summary of the legal basis 
(a) Textual reading 
4.120  The European Communities' challenge to the Ar gentine summary of the legal basis of the 
complaint, contained in document WT/DS293/17, has a wrong departure point as shown by a textual 
reading.  The European Communities resorts to a dictionary definition of "summary" in its request for 
a preliminary ruling. However, it fails to take into account that Article 6.2 qualifies the word 
"summary" with the adjective "brief".  The dictionary  definition of "brief" indeed refers to something 
"limited…concise in expression …"
76, This is a very different  standard from the concept of a 
summary which is close to an argument, as posited by the European Communities in its preliminary request. 
(b) Identification of the legal basis 
4.121  The failure to identify a specific provision of an  agreement allegedly violated certainly would 
be a problem.  However, this is not the case at hand where all relevant pr ovisions of the different 
agreements have been included in the Panel request.
77 
4.122  Contrary to European Communities' allegati ons, a comparison between Argentina's request 
for a Panel and it's request for consultations shows th e much more precise degree of specificity in the 
Panel request.78  Document WT/DS293/17 includes some, but not all, subparagraphs of articles from 
different agreements that were part of  the consultation process.  The case-law from Korea – Dairy79 
quoted by the European Communities is not relevant in this case, since in Korea – Dairy  the terms of 
reference included quotations of ge neral articles without any detail on particular subparagraphs within 
the article, in contrast with Argentina's request for a panel.  In order to clarify Argentina's position and 
the erroneous citation to Korea – Dairy , it is useful to quote the European Communities' description 
in that case: 
"Therefore, the EC requests that the panel c onsider and find that this measure is in 
breach of Korea's obligation under the provi sions of the Agreement on Safeguards, in 
particular of Articles 2, 4, 5 and 12 of the said Agreement and in violation of Article XIX of GATT 1994". 
4.123  This identification of the WTO legal provisions allegedly violated by Korea is strikingly 
different from the description provided in the curren t panel request.  Therefore, the legal basis has 
been properly identified. 
(c) The issue of multiple obligations 
4.124  Although the EC Request addresses the issue of mu ltiple obligations, it should be rejected for 
two reasons.  First, the WTO precedent used in by  the European Communities to support it's views is 
completely different from the case at hand.  In the precedent, Korea – Dairy , multiple obligations 
                                                     
 
76 The New Shorter Oxford English Dictionary , 1993 Edition, page 282. 
77 WT/DS293/17, page 2, indents a) b) c) and d). 
78 WT/DS293/1. 
79 Section III.B EC request for preliminary ruling.  WT/DS291/R 
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  were embodied within the main articles quoted broadly by the complainant.  In contrast, in the current 
case, Argentina has put forward the Panel's terms of reference with enough detail to identify articles and subparagraphs containing specific obligatio ns infringed by the European Communities' de facto 
moratorium .  Second, in the case at hand, the subparagr aphs of specific agreements quoted by the 
European Communities do not contain multiple ob ligations, they simply set forth the necessary 
requirements to demonstrate an infringement of the WTO's provisions.  The fulfilment of each requirement necessary to find an inconsistency is something to be develope d through the arguments 
that the complaining parties will present to the Pane l in their First Written Submission and subsequent 
communications.  
4.125  To require the development of the rationale and argument underlying each claim is contrary 
to well-established and recently confirme d WTO jurisprudence, as in the case of Canada – Wheat 
Exports and Grain Imports .  In other words, the European Communities' challenge is simply an 
attempt to impose a requirement to submit a narrative  that is more proper for arguments than for a 
challenge of a legal basis for a claim. 
5. The lack of prejudice 
4.126  As established by the Panel in the EC – Bed Linen, prejudice has to be shown in order for an 
Article 6.2 claim to prevail.  Argentina denies th at the European Communities has suffered prejudice 
in this proceeding as a consequence of the Terms of Reference set out in its panel request.  There is 
neither lack of specificity of the "measure at issu e" nor inaccuracy in the identification of the WTO' 
obligations violated by the European Communities. 
4.127  The European Communities' claim of prejudice and alleged inability to prepare its defence 
lacks credibility when one considers the extensiv e consultations in this case.  Argentina provided 
written questions to the European Communiti es and consulted as required by the DSU.  
4.128  Moreover, the European Communities argues th at because of the obscurity of the panel 
request, it is unable to answer the case.  This argumentation must be proved in light of the 
requirements of Article 6.2 of the DSU.  The European Communities' complaint is merely an 
unsubstantiated assertion of prejudice.  WTO case law demonstrates that such assertions simply do not constitute demonstrated or s ubstantiated prejudice for the purposes of Article 6.2 of the DSU. 
4.129  Finally, prior panels have rightly determined that whether there is prejudice during the panel 
proceedings can only be determined at the end of such proceedings.  Because the European 
Communities requested a preliminary ruling to be gr anted prior to the presentation of the First Written 
Submissions, it must carry the burden of proving that it has suffered prejudice at this early stage of the 
proceedings. 
E. F
IRST WRITTEN SUBMISSION OF THE UNITED STATES  
1. Introduction 
4.130  The European Communities has adopted appr oval procedures for agricultural products 
produced with the benefit of modern biotechnology.   Up to October 1998, the European Communities 
implemented those procedures, a nd approved more than ten biotech  products.  Consumers in the 
European Communities have been en joying the benefits of these products, without any adverse health 
or environmental effects.   WT/DS291/R 
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  4.131  Starting in October 1998, however, the Europ ean Communities suspended its own approval 
procedures.  In particular, the European Communities suspended consideration of  applications for, or 
granting of, approval of biotech products under the European Communities' approval system.  
Particular product applications might make some pr ogress, in fits and starts, through the European 
Communities' approval system, but the European Communities has failed to allow any new biotech 
product to move to final approval since October 1998.   
4.132  The European Communities' adoption of a mora torium on product approvals was not adopted 
in a transparent matter.  Indeed, it was not published in any official journal or otherwise 
memorialized.  Nonetheless, the moratorium is wi dely-recognized, including by leading EC officials.  
And, it is just as effective as any amendment to  the European Communities' approval legislation 
formally enacted into law.   
4.133  The United States submits that the European Communities' adoption of the moratorium is 
inconsistent with the European Communities' obligations under the WTO Agreement, and in 
particular the SPS Agreement .  While Members are allowed to ma intain approval systems – and the 
United States is not objecting to the European Co mmunities maintaining such  a system for biotech 
products – the procedures under that system must  be undertaken and completed "without undue 
delay."  It is hard to think of a situation that in volves "undue delay" more than a complete moratorium 
on approvals.  In this case, the European Co mmunities can present no scientific basis for a 
moratorium on biotech approvals.  In fact, many of the products caught up in the European 
Communities' moratorium have been positivel y assessed by the European Communities' own 
scientific committees.  In short, having establis hed a biotech  approval regime, the European 
Communities is obligated to apply those procedures fair ly and transparently, and without undue delay.   
4.134  In addition to the moratorium on the approval of  new biotech products, six EC member States 
have adopted marketing or import ba ns on biotech products that previously have been approved by the 
European Communities.  These product-specific bans , like the moratorium, are not based on science 
and are thus inconsistent with the European Comm unities' obligations under the WTO Agreement.   
4.135  In challenging the European Communities' mo ratorium under the DSU, the United States is 
simply calling on the European Communities to allow its own approval procedures to run their course.  
The United States is confident that once the Eu ropean Communities allows its scientific and 
regulatory procedures to reach their conclusion,  it will once again approve new biotech products, 
benefitting EC consumers and biotech producers around the world.   
2. Statement of facts 
(a) Biotechnology 
4.136  Modern biotechnology has a number of pr oven benefits for human health and the 
environment, including higher agricultural out put, more nutritional f ood products, and lower 
utilization of agricultural chemicals, fertili zers, and water in commercial farming.  
4.137  Modern biotechnology can significantly increase ag ricultural output by protecting plants from 
factors that reduce yields, such as pests, diseases, spoilage and ex treme weather conditions.  A report 
issued by seven national and international academ ies of science ("Multinational Science Academies 
Report") concluded that modern biotechnology must pl ay a role in addressing the shortage of food in 
the developing world, where 800 million people curr ently do not have access to sufficient food and 
malnutrition is a contributing factor in the deaths  of six million children under the age of five each 
year.  In its Statement on Biotechnology, the Fo od and Agriculture Organization of the United  WT/DS291/R 
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  Nations ("FAO") said, "genetic engineering h as the potential to help increase production and 
productivity in agriculture, forestry and fisheries.  It could lead to higher yields on marginal lands in countries that today cannot grow enough food to feed their people."  A Joint FAO/World Health 
Organization ("WHO") report of scientific experts recognized that "developing countries look on 
[recombinant DNA] technology as a means of addre ssing the need to produ ce sufficient quantities of 
nutritionally adequate and safe food fo r their growing populations."   
4.138  Biotechnology is also helping to increase the nutritional value of foods.  The multinational 
science academies report recognized that "[f]oods can  be produced through the use of [genetic 
modification] technology that are more nutritious, stab le in storage, and in principle health promoting 
– bringing benefits to consumers in both industr ialized and developing nations."  Further, the 
Pontifical Academy of Sciences stated that "the nut ritional enhancement of foods, either in terms of 
amino acid balance or in enhancing the presence of vitamins or their precursors ... can be attained 
more efficiently and precisely with the use of methods that are now available involving the direct 
transfer of genes."  
4.139  Modern biotechnology can also provide numer ous environmental benefits, including, as 
stated by the Research Directorate-General of th e European Commission, "' cleaner' agriculture."  
Biotech products that are resistant to insect pests require less insecticide to achieve a given level of 
protection than products that are not resistant to su ch pests.  The use of biotech crops also permits 
farmers to employ conservation tillage techniqu es that reduce soil disturbance and erosion and 
increase carbon sequestration.  In addition, modern biotechnology is producing crops that are able to 
absorb nitrogen and phosphorous at elevated rates, thus reducing the amount of fertilizer that needs to 
be applied.  Scientists are also  developing crops that require less water, which will not only increase 
productivity in areas with little water but also re duce the need for large-scale irrigation, thus 
protecting supplies of fresh water and reduci ng harm to ground an d surface water quality. 
4.140  The safety of biotech products has been confirmed by scientific reports issued under the 
auspices of renowned internati onal institutions, such as the F AO and WHO, seven national and 
international academies of science, and the Organization for Economic Co-operation and 
Development, as well as independent scientists in th e United States, Africa and Europe.  In fact, the 
European Commission itself has endorsed the safety of  biotech products, declaring that "the use of 
more precise technology and greater regulatory scrutin y probably make [biotech products] safer than 
conventional plants and foods." 
4.141  The scientific findings on the saf ety of biotech products are confirmed by empirical evidence.  
For the past decade, farmers in various parts of th e world have been sowing and harvesting millions of 
acres of transgenic corn, soybeans, rapeseed, potatoes and cotton, all of which are used, to greater or 
lesser degrees, in the production of food products or animal feed. The multinational science 
academies report concluded that "[t] o date, over 30 million hectares of transgenic crops have been 
grown and no human health problem associated specif ically with the ingestion of transgenic crops or 
their products have been identified."  Similarly, the French National Academy of Science noted that 
transgenic crops are widely cultivated, and "the re has never been a health problem regarding 
consumers or damage to the environment."  
4.142  By 2002, five and a half to six million fa rmers were cultivating crops derived from 
recombinant DNA technology on 58.7 million hectares (145 million acres) of land.  Since 1996, the 
global land area devoted to transgenic crops has grown thirty-five-fold.  Transgenic crops are 
cultivated in sixteen countries, which together acc ount for more than half the world's population.  
Worldwide, fifty one percent of soybeans ar e produced from transgenic seed, as well as 
twenty percent of cotton, twelve percent of oil seed rape (canola) and nine percent of corn.   WT/DS291/R 
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  (b) Moratorium on approvals of biotech products 
4.143  Since October 1998 – the last date of a biotech product approval -- the European 
Communities has failed to approve any new biotech  products under its nove l foods or deliberate 
release legislation.  The United States submits that this failure to approve a ll pending applications is 
the result of a de facto  moratorium under which the Europe an Communities has suspended the 
consideration of applications for, or granting of , approval of biotech products under its pre-market 
approval system.   
4.144  The moratorium became widely known no later than June 1999, when it was announced by 
Environment Ministers of five member States.  In particular, at a Council Meeting of EC Environment 
Ministers in June 1999, Environment Ministers of Denmark, Greece, France, Italy and Luxembourg issued a Declaration stating: "in exercising the powers vested in them regarding the growing and 
placing on the market of genetically modified organisms … they will take steps to have any new 
authorizations for growing and placing on the market suspended." 
4.145  The statements of Commission and member St ate officials confirm the existence of a 
moratorium.  For example, as early as July 2000, European Environment Commissioner Margot Wallström publicly admitted the existence of a "m oratorium," calling it "illegal and not justified."  
This sentiment was reiterated at a press confer ence in October 2001 following a meeting of the 
Council of Environment Ministers when Wallström re portedly "admitt[ed] that no end was in sight for 
the moratorium, which she said was an illegal, illogi cal, and otherwise arbitrary line in sand."  She 
added that there was no other EU legislation in the sa me situation in which "we just simply decline to 
take a decision." 
4.146  European Commissioner for Health and Consumer  Protection, David Byrne, stated in June 
2000 that the reluctance of member States to approve the placing on the market of new biotech 
products "has resulted in a complete standstill in the current authorizations and a de facto  moratorium 
on the commercial release of GMOs ."  Commissioner Byrne again acknowledged the existence of the 
moratorium in February 2003 when he implored member States that "we must lift the moratorium."  
4.147  The statements of European Commission officials acknowledge not only the existence of the 
moratorium but also that it is maintained without scientific or legal justification.  In fact, EC 
Environment Commissioner Margot Wallström herself remarked after pleading unsuccessfully with 
the Environment Council to lift the moratorium: "W e have 11 GMO seed notifications approved. ... 
But then there was an arbitrary line drawn before I came into office [in 2000] to stop all approval for 
the 13 other pending applications.  But many of these 13 are simply varieties of the first 11 approved.  
They are essentially the same products.  There is no sc ience that says these are more or less dangerous 
than others."  Similarly, Beate Gminder, spokesw oman for Commissioner Byrne, stated that "[t]he 
moratorium has no legal basis."   
4.148  Commission documents also confirm the existence of the moratorium.  A Commission 
Working Document dated November 2000 states "the current authorization procedure for commercial 
release of GMOs, including those that may end up in the food chain, has ground to a standstill.  A Commission Press Release dated July 2001 states that  the adoption of new legislative proposals "will 
contribute towards the lifting of the de facto  moratorium on the commercial release of GMOs."  An 
October 2001 internal Commission working paper stat es that "[t]his reluctance to go forward with 
authorizations of GMOs has resulted in a de facto  moratorium on the marketing of new GMOs and 
impacted on product approvals under the sector-based legislation."  In July 2003, a Commission fact 
sheet on GMO regulation stated that "[t]he revi sed Directive [2001/18] and the two proposals for 
Regulations are expected to pave the way for a re sumption of GM authorizations in the European  WT/DS291/R 
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  Union," implying that authorizations had been suspended.  A document issued by the General 
Secretariat of the Council of the European Uni on stated that the proposed rules on traceability and 
labelling of biotech products could "possibly lead to the lifting of the current moratorium."  More 
recently, in a January 2004, Communication to the Commission, Commission officials admitted that 
"no authorizations have been granted since Oc tober 1998" despite the adoption of an "interim 
approach" to biotech product approvals  allegedly adopted in July 2000.  
4.149  The existence of a moratorium on approvals of biotech products is further evidenced by the 
failure of the European Communities to approve  a single biotech product since October 1998 under 
Directive 2001/18 (and its predecessor Directive 90/220), as well as under Article 4 of 
Regulation 258/97.  Currently, twenty-seven appli cations for placing biotech products on the market 
are delayed at various stages of the approval process under Directive 2001/18 (and, prior to 17 
October 2002, under Directive 90/220) and Regulation 258/97. 
4.150  There are eighteen biotech products with notif ications pending under Directive 2001/18 that 
were first submitted under Directive 90/220 and then failed to advance through the approval process.  
Of these eighteen products, nine were stalled at the Commission level at the time Directive 90/220 
expired, some having languished for as long as six y ears and five months.  All nine of these products 
received favourable initial assessments from the s ponsoring member State and positive opinions from 
the Scientific Committee for Plants, which in each case found "no evidence to indicate that the 
placing on the market [of the product in question] is likely to cause any adverse effects on human 
health and the environment."  The remaining nine notifications were delayed at the member State 
level under Directive 90/220 and have  awaited consideration for as long as four years and ten months.  
4.151  Under Regulation 258/97, the requests for five products have been delayed at the Commission 
level for as long as five years.  Each of these products received favourable assessments for their 
sponsoring member State and two products also received positive opinions from the Scientific 
Committee on Food.  An additional four requests are pending with the individual member States, 
some of which were submitted as early as July 1998.  
(c) Member States' marketing or import bans 
4.152  Six EC member States – France, Germany, Austria, Italy, Luxembourg, and Greece – have 
invoked the so-called "safeguard" provisions in Di rective 90/220 and Regulation 258/97 with respect 
to biotech products that have been approved for sal e on the European market.  Five member States 
enacted marketing bans (Austria, France, Germany, Italy, and Luxembourg) and one (Greece) enacted 
an import ban.   
4.153  In particular, Austria issued three measures prohibiting the "placing on the market" of three 
corn biotech products: Bt-176, MON810 and T25; France issued two Orders on November 16, 1998, 
prohibiting the "placing on the market" of two rapeseed biotech products: MS1/RF1 and Topas 19/2; 
Luxembourg issued a Ministerial Order on February 7, 1997, prohibiting the "use and sale" of biotech 
corn Bt-176; Germany issued a Ruling 31 March 2 000, "suspending the approval" and the placing on 
the market of Bt-176; .Italy i ssued a Decree on 4 August 2000, suspending the "commercialization 
and use" of the following corn products: Bt-11,  MON810, MON809 and T25; and Greece issued a 
Decree 8 September 1998, prohibiting the importa tion of Agrevo oilseed rape (Topas 19/2).  
4.154  In each case, the applicable scientific committee of the Eu ropean Communities found that 
there was no scientific basis for the member State sa feguard measure.  Yet, those measures all remain 
in place.   WT/DS291/R 
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  3. Legal discussion 
(a) General moratorium violates the SPS Agreement  
4.155  The general moratorium is one component of  the European Communities' biotech approval 
regime; in particular, the general moratorium is a moratorium on approvals under the novel foods and 
deliberate release legislation.  The European Communities' biotech approval regime is unquestionably an SPS measure.  Directive 2001/18 states that one of  the objectives of the Directive is "to protect 
human health and the environment" when, among other things, "placing on the market genetically modified organisms as or in products within the Community."  Similarly, its predecessor legislation, 
Directive 90/220, states that one of its objectives is  "to protect human health and the environment" 
from, among other things, "placing on the market pr oducts containing, or c onsisting of, genetically 
modified organisms intended for subsequent delib erate release into the environment."  Finally, 
Regulation 258/97 states that "[ f]oods and food ingredients fa lling within the scope of the 
Regulation must not present a danger for the consum er" or be "nutritionall y disadvantageous."   
4.156  In addition to the purpose that is set out so clear ly in the approval legislation, statements made 
by European Communities and member State offici als reinforce that the purpose of the European 
Communities' approval regime, including the general moratorium, is to protect human, animal, or 
plant life or health from certain risks.  Over the past five years, European Communities and member 
State officials have frequently stated that the mora torium has been imposed to protect "citizens" and 
"the environment."  Moreover, a recent Commissi on "Working Document" indicated that the freeze of 
the current authorization procedure for biotech pro ducts has occurred in light of the fact that the 
"public is increasingly concerned about potential implications for human health and the environment ."  
4.157  These justifications for the European Commun ities' approval regime, including the general 
moratorium, fall within the definition of an SPS measure under the Agreement.  For example, 
concerns that a biotech product might lead to an al lergic or toxic reaction on the part of certain 
animals, e.g., concerns that some varieties could ha rm beneficial organisms as well as target 
organisms, fall within the definition of Annex A, paragraph 1(a)—which covers measures applied to 
protect "animal or plant life or health" from ri sks arising from "disease-causing organisms."  The 
concern that a biotech product might lead to an allergic or toxic reaction on the part of consumers, e.g., concerns regarding unacceptable le vels of pesticide residue in p esticide-producing plant varieties, 
allergic reactions based on consumption of a biotech  variety that incorporates a genetic trait that can 
lead to such reactions, or the presence of toxins or other contaminants in foods containing biotech 
products, falls within the definition of Annex A, paragraph 1(b)—which cove rs measures applied to 
protect "human or animal life or health" from risk s arising from "contaminants" or "toxins" in "foods, 
beverages or feedstuffs."   
4.158  Similarly, concerns that widespread consumpti on of varieties containing antibiotic marker 
genes might lead to the development of antibiotic resistant strains of bacteria also fall under the 
definition of 1(b).  Such concerns have been ch aracterized as food safety issues.  Thus, a measure 
based on these concerns is a measure designed to protect "human or animal life or health" from 
"disease-causing organisms" in "foods, beverages or feed stuffs."  Additionally, concerns regarding the 
cross-contamination (or transfer) of bi otech products to non-target organisms, 
e.g., concerns that 
herbicide tolerance could be transferred from a biotec h variety to a wild variety, fall within the scope 
of Annex A, paragraph 1(d)—which covers measures applied "to preven t or limit other damage within 
the territory of the Member from the entry, establishment or spread of pests."  Annex A defines "pests" to include weeds, defined in the New Shorter Oxford English Dictionary  as "plant[s] that 
grow[] ... where [they are] not wanted."  Thus, a m easure based on this risk falls within the definition 
of Annex A, paragraph 1(d).    WT/DS291/R 
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  4.159  The general moratorium, as one component of the European Communities' biotech approval 
regime, qualifies as a "measure."  Approval proce dures are listed in the definition of SPS measure in 
Annex A as a specific example of an SPS measure.  The fact that the moratorium component is not 
embodied in a single written document does not alter its status as a measure.  Certainly, if the 
European Communities had acted transparently and amended its novel food and deliberate release 
regulations to provide for an indefinite suspensi on of approval procedures, the amendment would be a 
"law," "decree," or "regulation" and fall within th e scope of an SPS "measure".  The fact that the 
European Communities has adopted the moratorium  in a nontransparent way, without official 
publication, in no way changes that result.  
4.160  Moreover, the SPS Agreement  includes in its definition of "m easure" the terms "requirement" 
and "procedure", which are not necessarily  in written form.  For example, the New Shorter Oxford 
English Dictionary defines the term "procedure" as a "particular mode or course of action" or a "set of 
instructions for performing a specific task which ma y be invoked in the course of a program."  Under 
the ordinary meaning of the term "procedure," a suspension by the Eur opean Communities of the 
consideration of applications for, or granting of, approval of biotech products is an unwritten 
procedure covered under the SPS Agreement . 
4.161  In addition, the list of measures subject to the SPS Agreement  is not exhaustive.  Paragraph 1 
of Annex A states, in relevant part, that "[s]anitary or phytosanitary measures include  all relevant 
laws, decrees, regulations, requirements and proce dures."  The use of the word "include" indicates 
that the Agreement covers more than just the iden tified types of measures, and should be read to 
include other measures that may not fit squarely within the illustrative list.  
4.162  Finally, the object and purpose of the SPS Agreement , and more broadly the WTO 
Agreement, supports a broad interpretation of what  constitutes a "measure."  The preamble of the 
Agreement provides that one object and purpose of the Agreement is to "minimize [the] negative 
effects [of SPS measures] on trade."  If a WTO Memb er could avoid its SPS obligations by adopting a 
nontransparent, unwritten SPS measure that has a nega tive effect on trade, the objects and purposes of 
the SPS Agreement  would not be fully realized.   
4.163  The general moratorium also "affects intern ational trade" and, thus, meets the second 
requirement under Article 1.1 of the SPS Agreement .  Biotech products may not be placed on the 
market in the European Communities without first being approved under the requi red legislation.  The 
European Communities' general moratorium has since October 1998 precluded the placing on the 
market of any and all biotech products in the European Communities, including imported biotech products.  The general moratorium, t hus, is effectively an import ban that affects any and all foreign 
biotech products and, thus, the "international trade" in those products.  
4.164  The European Communities has failed to comply  with the requirements of Article 8 and 
Annex C, paragraph 1(a) of the 
SPS Agreement .  These provisions require that "with respect to any 
procedure to check and ensure the fulfilment of  sanitary or phytosanitary measures, ... such 
procedures are undertaken and completed without undue delay ... ."   
4.165  The European Communities' approval process for biotech products is subject to the 
requirements of Article 8 and Anne x C.  First, the European Communities' process is an "approval 
procedure" under the Agreement.  Annex C defines "approval procedures," as including, inter alia , 
"procedures for sampling, testing and certification. "  Because biotech products must be approved 
before they can be placed on the market, the pro cedures are analogous to the types of procedures 
specifically articulated in Annex C, e.g., procedures for certification.   WT/DS291/R 
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  4.166  Second, these procedures are imposed to "ensure"  that the requirements of the European 
Communities' approval legislation for biotech produc ts are met.  Third, the European Communities' 
approval legislation is a "sanitary or phytosanitary measure" as defined in Annex A, paragraph 1 of 
the SPS Agreement  because it is applied for the purpose of protecting human, animal, or plant life or 
health or preventing or limiting other damage wi thin the territory of the Member from certain 
enumerated risks in Annex A.  
4.167  The term "undue delay" is not defined in Annex C.  Examination of the "ordinary meaning" 
of the words "in their context and in the light of [the] object and purpose" of the treaty, as required by 
the customary rules of treaty interpretation reflected  in Article 31 of the Vienna Convention, helps 
provide content to the term.  The ordinary meaning of "undue" is "inappropria te, unsuitable, improper; 
unrightful; unjustifiable. Going beyond what is warra nted or natural; excessive; disproportionate."   
The ordinary meaning of delay is "hindrance to progress; (a period of) time lost by inaction or 
inability to proceed; impede the progress of, make late, hinder."  Thus, the ordinary meaning of 
"undue delay" under paragraph 1(a)  of Annex C is the "unjustifiable" and "excessive" "hindrance" in 
undertaking or completing an approval procedure.  The ordinary meaning of "undue delay" suggests 
that both the reason for the delay and its duration ar e relevant considerations  in determining whether 
the delay is "undue". 
4.168  Although it may be difficult in particular cases to decide whether approval procedures are 
undertaken and completed without undue delay, the United States submits that an across-the-board 
suspension of approval procedures must be cons idered an "undue delay" under Annex C.  As 
recognized by EC officials, there is no scientific  basis for the failure to move forward under the 
procedures and timelines provided in the European Communities' own legislation.  Moreover, many 
of the biotech products caught up in the Europ ean Communities' general moratorium have already 
been subject to positive assessments by the sponsor ing member State and the European Communities' 
own scientific committee.   
4.169  Where the European Communities' own legislation provides procedures and timelines for the 
approval of biotech products, an indefinite susp ension of that approval procedure, without any 
scientific justification, must be consid ered "undue delay" under Annex C.  
4.170  The European Communities has also violated Article 7 and Annex B,  paragraph 1 of the 
SPS Agreement .  Article 7 specifically states that  "Members shall notify changes in their sanitary or 
phytosanitary measures and shall provide informa tion on their sanitary or phytosanitary measures in 
accordance with the provisions of Annex B"  Annex B,  paragraph 1, states that "Members shall ensure 
that all sanitary and phytosanitary regulations which have been adopted are published promptly in 
such a manner as to enable interested Members to become acquainted with them."  As the European 
Communities has failed to publish, and, therefore, to "publish[] promptly," the existence of the 
general moratorium, the European Communities has acted inconsistently with its obligations under 
Article 7 and Annex B. 
4.171  The general moratorium is also inconsistent with  each of the related procedural obligations in 
Annex C(1)(b) of the SPS Agreement , considering each element of this provision as follows:   
• "the standard processing period of each proce dure is published or that the anticipated 
processing period is communicated to the applicant upon request": Although the 
European Communities' novel food and deliberate release directives contain 
processing periods, under the general moratorium those processing periods are not followed.  Instead, the European Communiti es has imposed an indefinite delay.  
However, since the European Communities does not acknowledge the moratorium,  WT/DS291/R 
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  the standard processing period is not publis hed, and the anticipated processing period 
is not communicated to the applicant.   
 
• "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":  U nder the general moratorium, the European 
Communities does not promptly examine documentation and inform the applicant of all deficiencies.  To the contrary, appli cations under the EC directives are stalled, 
without explanation. 
 
• "the competent body transmits as soon as po ssible the results of the procedure in a 
precise and complete manner to the applicant so that corrective action may be taken if necessary": Under the general moratorium, results of procedures are not promptly communicated to applicants so that co rrective action may be taken.  Instead, 
applications are stalled in the appr oval process without explanation.   
 
• "even when the application has deficienci es the competent body proceeds as far as 
practicable with the procedure if the a pplicant so requests": Under the general 
moratorium, the European Communities does not  proceed as far as practicable in the 
approval process.  Instead, one again, appli cation are stalled in the approval process. 
 
• "and that upon request, the applicant is info rmed of the stage of the procedure, with 
any delay being explained":  Under the genera l moratorium, delays are not explained.  
To the contrary, the European Communities does not even inform applicants of the 
existence of the moratorium.  
 4.172  To the extent the European Comm unities' suspension of consideration of applications for, or 
granting of, approval of biotech pr oducts (the general moratorium) is  preventing the sale or marketing 
of biotech products, the general moratorium violates Article 5.1 of the SPS Agreement .  In order for a 
measure to be based on a risk assessment in accordan ce with Article 5.1, the following two criteria 
must be met:  (1) "the study put forward as a risk  assessment [must] meet the requirements of a risk 
assessment set forth in Article 5.1 and Annex A of the SPS Agreement "; and (2) "the sanitary 
measures ... selected [must be] based on this risk assessment ... ."  Th e European Communities has not 
met either requirement.  Each is analysed separately below. 
4.173  First, the European Communities has failed to put forth either of the two types of risk 
assessments defined in Annex A, paragraph 4.  The general moratorium was imposed to protect 
against risks that fall within Annex A, paragraph 1( a) (measures applied to protect animal or plant life 
or health from disease-causing organisms), paragraph 1(b) (measures applied to protect human or animal life or health from contaminated or toxic f ood or feedstuffs) and paragraph 1(d) (measures to 
prevent or limit damage from entry or spread of pests).  The European Communities, however, did not 
utilize either type of risk assessment when it impo sed the general moratorium.  Indeed, there is no 
evidence in the public record th at the general moratorium is based on any scientific assessment 
whatsoever, much less one of the two types of risk  assessments defined by Annex A, paragraph 4.   
4.174  Second, the general moratorium is not "based on"  a risk assessment as required by Article 5.1.  
As the Appellate Body explained in EC – Hormones , Article 5.1 requires that a measure there be a 
"rational relationship" between the measure at issue and the risk assessment.  The European 
Communities cannot argue that the gene ral moratorium bears a relationshi p, rational or otherwise, to a 
risk assessment when there is no evidence  that any risk assessment ever existed. WT/DS291/R 
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  4.175  The general moratorium is also inconsistent  with the European Communities' obligation 
under Article 2.2 of the SPS Agreement .  Article 2.2's "sufficient scientific evidence" obligation 
requires that there be a "rational or objective rela tionship between the SPS measure and the scientific 
evidence. The basic obligations provided in Article 2.2 have been viewed as being specifically applied 
in Article 5.1.  Therefore, panels and the Appella te Body have found that where a Member maintains 
a measure in violation of Article 5.1 – that is, wh ere the measure is not based  on a risk assessment as 
required under Article 5.1 and Annex A, paragrap h 4 – the Member, by implication, "also act[s] 
inconsistently with its more gene ral obligation in Article 2.2."  
4.176  The general moratorium also violates Article 5.5 of the SPS Agreement , which requires that 
Members aim to be consistent in their application of  the appropriate level of sanitary or phytosanitary 
protection against risks to human, animal, or pl ant life or health.  The European Communities, 
however, has identified different levels of sanitary  and phytosanitary protection in two different yet 
"comparable" situations:  (i) the le vel of protection in respect of biotech products that exists under the 
general moratorium; and (ii) the level of protec tion in respect of products produced using biotech 
processing aids. 
4.177  The European Communities does not regulate pr oducts produced with biotech processing aids 
as such.  In contrast to new biotech processing ai ds, the European Communities has imposed a general 
moratorium on other new biotech products, resulting in an appropriate level of protection of zero risk.   
4.178  First, these distinct levels of protection are applied in comparable situations.  The same 
substances may be present in products produced  using biotech processing aids as are present in 
biotech products themselves.  Once present in the final product, th e biotech products and products 
produced using biotech processing aids have the sa me potential adverse health risks and risks of 
establishment or spread of disease or pests and asso ciated biological and economic consequences.  
4.179  Second, the difference between the level of pr otection for biotech products and the level of 
protection for products produced with biotech pro cessing aids is"arbitrary or unjustifiable."  As 
discussed above, elements of the biotech products us ed in the production of the final products may be 
present in the final product.  In such cases, the sa me potential risks to human health are present for 
new biotech processing aids and other new biotech products.   
4.180  Third, the European Communities has applied the general moratorium in a manner that results 
in "discrimination or a disguised restriction on international trade."  The European Commuities' 
application of the general moratorium exhibits a ll three "warning signals" and an "additional factor" 
which indicate that the measure discriminates or pr ovides a disguised restriction on international 
trade.  
4.181  First, as discussed above, the difference between the levels of protection for biotech products 
and products produced with biotech processing aids is  "arbitrary or unjustifiable."  Second, the degree 
of difference between the levels of protection is s ubstantial – biotech products are subject to a high 
level of protection ( i.e., zero tolerance for risk, effectivel y banning new biotech products) whereas 
products produced with biotech processing aids ar e not subject to European Communities' regulation 
at all.  Third, the general moratorium is not based on a risk assessment.   
4.182  Finally, the "additional factor" is a disproportio nate effect of the general moratorium on 
producers outside the European Communities as co mpared to producers within the European 
Communities.  In 2001, the European Communities a ccounted for less than four-tenths of one percent 
of the worldwide land area devoted to growing bi otech products.  In contrast, the United States, 
Argentina, Canada, and China accounted for ninety -nine percent of the total land area devoted to  WT/DS291/R 
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  biotech products in 2001.  For producers in these countries, the moratorium on approvals of biotech 
products has had a substantial negative effect. 
4.183  The European Communities also has violated Article 2.3 of the SPS Agreement .  The general 
obligations set out in Article 2.3 are applied mo re specifically under Article 5.5.  As such, the 
Appellate Body has found that wh ere all three elements under Article 5.5 have been fulfilled, the 
measures, by implication, necessarily violate the mo re general obligations set  out in Article 2.3.  
(b) Product-specific moratoria  violate the SPS Agreement  
4.184  The United States argues additionally that the product-specific moratoria are separate 
measures which are also inconsistent with th e European Communities' obligations under the 
SPS Agreement .  In particular, the United States is al so challenging the European Communities' 
failure to consider for approval each of the twenty -seven applications for biotech products that are 
pending in the approval process.  
4.185  Because the product-specific moratoria and the general moratorium are similar measures in 
that both refer to the European Communities' failure to consider biotech products for approval, the 
analysis of the application of the SPS Agreement  and the violations of that Agreement are also based 
on similar arguments.  Accordingly,  arguments set forth in the sec tion above concerning the general 
moratorium are incorporated by reference. 
4.186  Additionally, the European Communities has put forth risk assessments for fourteen of the 
pending applications, which received favourable asse ssments from the member States to which these 
products were submitted and/or from the Scientific  Committee on Plants or the Scientific Committee 
on Food.  These opinions encompass both types of ri sk assessments referenced under Article 5.1 and 
paragraph 4 of Annex A as they examine:  (1) the likelihood of the establishment or spread of a pest , 
and (2) the potential for adverse effects on human or animal health arising from the presence of toxins 
or disease-causing organisms in food or feedstuffs .  All fourteen of these scientific assessments of 
pending applications concluded that there was no evidence that these biotech products would pose a 
risk to human, animal or plant life or health, or cause other damage.  
4.187  Although the European Communities has put fort h risk assessments for fourteen of the 
twenty-seven pending applications for approval of biotech products, the product-specific moratoria 
are not "based on" these risks assessments as required  by Article 5.1.  Specifically, there is no 
"rational relationship" between the European Comm unities' risk assessments and the product-specific 
moratoria.  To the contrary, there is an irrationa l relationship between the opinions of the scientific 
committees, which found no evidence that these products pose a risk to human or animal health or the 
environment, and the product-specific moratoria, which, in effect, ban these products from the EC 
market.  Because the product-specific moratoria ar e not "based on" the European Communities' risk 
assessments, the measures are inconsistent with Article 5.1 of the SPS Agreement .   
(c) 
EC member State marketing or import bans violate the SPS Agreement  
4.188  Like the moratoria (general and product-specifi c), the member State measures are (1) sanitary 
or phytosanitary measures, which (2) affect intern ational trade.  The gene ral purpose of the member 
State measures can be inferred from the text of the European Communities' legislation that the 
member States invoked when they enacted their import  or marketing bans.  In particular, Article 16 of 
Directive 90/220 allows member States provisionally to "restrict or prohibit the use and/or sale of [an 
approved] product" if the "member State has justif iable reasons to consider that [the] product ... 
constitutes a risk to human health or the environment. "  Similarly, Article 12 of Regulation 258/97 WT/DS291/R 
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  allows Members to "temporarily restrict or suspend the trade in and use of" an approved product if it 
has information that the approved product "endangers human health or the environment. "  As each of 
the member States enacted their measures pursuant to Article 16 of Directive 90/220 or Article 12 of 
Regulation 258/97, all of the measures were enacted for the purpose of protecting human health or the 
environment.  Second, and more importantly, the sanitary or phytosanitary purpose of the member State measures can be found in the measures themselves,  as well as in the justifications offered by the 
member States at the time the measures were adopted.  
4.189  The nine member State measures also "affect international trade," either "directly or 
indirectly," and, thus, meet the second requirement under Article 1.1.  By blocking the sale of such 
products within the country that maintains th e measure, the measures effectively block the 
importation of the products.  As such, each of the measures indisputably "affects international trade." 
4.190  The nine measures imposed by six member St ates are sanitary or phytosanitary measures 
which are not "based on" "risk assessment[s]" as required by Article 5.1 of the SPS Agreement .  
Although each of the six member States that have imposed bans on approved biotech products offered 
reasons for their measures – though unjustified acco rding to the scientific committees – none of the 
member States put forth a "risk assessment" as de fined in Annex A, paragraph 4.  Rather, the 
justifications offered by the member States typical ly expressed concerns about adverse effects of the 
banned products, or biotech produc ts in general, but did not include risk assessments of the banned 
products. 
4.191  The only risk assessments put forth for the banned products are the positive scientific 
assessments rendered by member States to which the products were submitted and the European 
Communities' own scientific committees, as well as the European Commission Decisions approving 
the products.  In the case of each member State ban, these favourable assessments were reaffirmed 
when the scientific committees considered and reje cted the information provided by the member 
States.  Thus, the member State measures do not bear a "rational relationship" to the European 
Communities' positive risks assessment, and are not "based on" a risk assessment, in violation of 
Article 5.1.  
4.192  The member State measures are also inconsistent  with the obligations under SPS Article 2.2, 
because they are not based on a risk assessment as requ ired by Article 5.1 and Annex A, paragraph 4. 
(d) Greek import ban violates Article XI 
4.193  The terms of the Greek measure make it unambi guously clear that the measure is an "import 
ban": "We prohibit the importing into the territory of Greece of seeds of the genetically modified 
rape-plant line bearing reference number C/UK/95/M5/1 ."  As an import ban, the Greek measure is a 
prima facie violation of Article XI:1 of the GATT 1994. 
F. F
IRST WRITTEN SUBMISSION OF CANADA  
1. Introduction 
4.194  In this dispute, Canada challenges: 
(a) The general suspension by the European  Communities of its own processes for the 
consideration of applications for, or th e granting of, approval for biotech products 
since 1998 (referred to hereinafter as the moratorium );   WT/DS291/R 
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  (b) In relation to the genetically modified vari eties of canola/oilseed rape identified in 
Annex I of Canada's Panel Request  (referred to hereinafter as the Specific Products ), 
the failure by the European Communities to consider or approve, without undue 
delay, applications for approval of such products (referred to hereinafter as the 
product-specific marketing bans ); and  
(c) The five national measures identified in  Annex II of Canada's Panel Request 
prohibiting the importation, marketing or sale of , in total, six varieties of genetically 
modified canola/oilseed rape and maize/co rn that have been approved under the 
European Communities' approval regime for biotech products (refe rred to hereinafter 
as EC member State national measures ). 
4.195  Biotech products cannot be marketed in the European Communities unless they have been 
approved.  The approval process involves an assess ment of the risks to human health and the 
environment.  The moratorium  effectively suspends the operation of key steps in this approval 
process, resulting in an across-th e-board marketing ban on biotech products that had not received 
approval as of October 1998, regardless of whether these products pose risks to human health or the environment.  Canada challenges the moratorium  as a distinct measure that is inconsistent with the 
SPS Agreement .   
4.196  The moratorium  has directly affected the operation of the approval process in relation to the 
Specific Products  resulting in the product-specific marketing bans .  The Specific Products  include the 
following varieties of herbicide-tolerant gene tically modified canola/oilseed rape: Ms1xRf1, 
Ms1xRf2, Ms8xRf3 and GT73.  Canada challenges the product-specific marketing bans  as distinct 
measures inconsistent with the SPS Agreement  and, in the alternative, the TBT Agreement .  Canada 
also challenges the product-specific marketing bans  as inconsistent with Article III:4 of the GATT 
1994. 
4.197  Finally, Canada challenges five EC member State national measures  (enacted by France (2), 
Greece, Austria and Italy) banning biot ech products as inconsistent with the SPS Agreement  and, in 
the alternative, the TBT Agreement .  Canada also challenges these national measures as inconsistent 
with Article III:4 and, in the case of Greece, Article XI:1 of the GATT 1994. 
2. Scientific background 
4.198  As has been recognized by the Eu ropean Communities, the nature of the risks associated with 
biotech products is similar to the nature of the risk s associated with conventionally bred plants.  It is 
not the process through which a plant with novel traits is developed that determines the risk, but rather 
the characteristics of the inserted gene(s) and the hos t plant, the environment in which the plant is 
released and the use to which the plant is put.  As  the nature of the risks associated with biotech 
products varies considerably from plant variety to variety, general assertions about the risks of biotech 
products, as a class, cannot be made.  Each biot ech product needs to be evaluated on a case-by-case 
basis, taking into consideration the factors outlined above. 
3. EC Legislation and the moratorium 
(a) The approval legislation 
4.199  The European Communities' approval regime for biotech products consis ts of two principal 
legal instruments:  Directive 2001/18 (and its predecessor, Directive 90/220) governing "the WT/DS291/R 
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  deliberate release into the environment of geneti cally modified organisms" and Regulation 258/97 
regulating "novel foods and novel food ingredients". 
4.200  Absent approval, biotech products covered by the European Communities' approval regime 
may not be placed on the market in the Europ ean Communities.  The approval regime outlines, inter 
alia, the procedures with which a company must comply  in order to obtain approval to place a biotech 
product on the market and the standards by which an application for approval is judged.  In summary 
form, those procedures are: 
• the manufacturer or importer of the product submits an application to the competent 
authority of the EC member State where th e product is to be placed on the market for 
the first time; 
 
• the competent authority conducts an initia l assessment ("IA") to ensure that the 
product complies with the technical requirements of the relevant legislation and to determine whether the product should be placed on the market; 
 
• the IA report is sent to the Commission and circulated to the other member States for 
their review and comment.  If the assessment was favourable, and no EC member State or the Commission objects to the appli cation, the competent authority consents 
to placing the product on the market;   
 
• if an EC member State or the Commi ssion objects to placing the product on the 
market, the Commission must adopt a decision in accordance with specific 
procedures laid down in the approval legisla tion after consultation with member State 
representatives; 
 
• typically, the Commission requests an opinion of the relevant Scientific Committee.  
Once the scientific opinion has been received, the Commission submits a draft measure to a Regulatory Committee composed of representatives of the EC member States for its opinion; 
 
• if the Regulatory Committee fails to render an opinion, or if it renders an opinion that 
conflicts  with the Commission's draft measure, the Commission "shall, without delay," submit its proposal relating to the measures to be taken to the Council of 
Ministers; 
 
• the Council of Ministers may, by qualified majority, adopt the proposed measure.  It 
may also, by qualified majority, reject the proposed measure.  If a qualified majority does not exist for either adoption or re jection, the Council is unable to act; 
 
• if the Council of Ministers has not acted w ithin three months from the date of the 
referral, the Commission "shall" adopt the proposed measure; 
 
• if a product is approved for placement on the market by one of the mechanisms set 
out above, either the competent authority that conducted the initial assessment or the 
Commission must issue its consent to the placing of the product on the market. 
 4.201  EC legislation contains "safeguard" clauses th at allow EC member States to provisionally 
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  has evidence that the product constitu tes a risk to human health or th e environment.  It is under these 
safeguard clauses that the EC member State national measures  have been adopted. 
(b) Moratorium on approvals of biotech products 
4.202  Since October 1998, the European Communities has imposed a moratorium  on the approval 
of biotech products.  The existence of the moratorium  is evidenced by the European Communities' 
failure to approve any biotech products for nearly five years and by numerous statements from EC 
officials.  
4.203  As a result of the weighted voting structur e in the relevant Regulatory Committee, EC 
member States have effectively stalled the consid eration or the granting of approval of biotech 
products.  Moreover, where EC member States have been successful in blocking approval by the Commission through their voting behaviour at th e Regulatory Committee stage, the Commission has 
failed to refer the matter to the Council to break  the deadlock, even tho ugh, as noted above, it is 
required to do so. 
4. The moratorium 
(a) The moratorium violates the SPS Agreement  
4.204  The moratorium  meets both the form and purpose elements necessary to be considered an 
SPS measure under the SPS Agreement .  In terms of form, the moratorium  consists of concerted acts 
and omissions of the European Communities and it s member States to stall decision-making with 
respect to biotech product applications at key stages of the approval process. Thus, the moratorium  
effectively renders inoperative the approval pr ocedures under Regulation 258/97 and Directives 
2001/18 and 90/220 , resulting in an indefinite suspension of the placing on the market of biotech 
products.  This indefinite suspension converts the pre-marketing approval requirement established by 
Regulation 258/97 and Directives 2001/18 and 90/220 into an across-the-board marketing ban on 
biotech products that had not been approved as of Oc tober 1998.  As a ban is clearly a "measure", the 
moratorium  is also a "measure" for the purposes of the SPS Agreement .  
4.205  The purpose of the moratorium  is to protect against risks identified in paragraph 1 of 
Annex A to the SPS Agreement .  As the moratorium  is not based on a specific legal instrument that 
expressly sets out the justification for this measure, the purpose of the moratorium  must be inferred 
from the context.  First, the declarations of th e EC member States confirm that the purpose of the 
moratorium  is to protect human health and environment from risks arising from biotech products. 
Second, it is reasonable to infer that the purpose of the moratorium
 is to protect against the same risks 
to human health and the environment against whic h the European Communities' approval legislation 
is intended to protect.  A review of the purposes of the European Communities' approval legislation 
demonstrates that this legislation is designed to pr otect against the risks identified in paragraph 1(a) 
through (d) of Annex A of the SPS Agreement .  Consequently, the moratorium  meets the purpose 
element of an SPS measure. 
(i) The moratorium violates Article 5.1 
4.206  The European Communities has offered no risk assessment as a justification for effectively 
suspending the approval procedures for biotech products.  Therefore, the moratorium  is not "based 
on" a risk assessment as required by Article 5.1. WT/DS291/R 
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  (ii) The moratorium violates Article 5.6 
4.207  Due to the nature of the moratorium , it is not clear whether the moratorium , rather than the 
European Communities' approval legislation, is intended to reflect the European Communities' 
appropriate level of sanitary and phytosanitary protec tion ("level of protection").  For the purposes of 
its Article 5.6 argument, Canada assumes that the European Communities' level of protection is that 
which the European Communities has expressed in its biotech approval regi me and general food 
safety legislation (a high level of protection).  Howeve r, if Canada is mistaken on this point, and the 
European Communities' level of protecti on is that which is reflected in the moratorium  (zero-risk 
level), then Canada advances, in the alternative , its argument with respect to Article 5.5.   
4.208  The European Communities has violated Article 5.6 of the SPS Agreement  because the 
moratorium  is more trade restrictive than required to  achieve the European Communities' level of 
protection.  An alternative SPS measure is reasonabl y available; the alternative measure achieves the 
European Communities' level of protection; and the alternative measure is significantly less restrictive 
to trade. 
4.209  First, the obvious alternative SPS measure is for the European Communities to comply with 
its existing approval regime for biotech products a nd permit biotech products to be considered for, 
and granted or denied, approval in accordance wi th the procedures established by that regime.  
Second, the European Communities' appropriate level of protection is  reflected in the relevant EC 
legislation and appears to be a "high level of protec tion".  It is reasonable to assume that the European 
Communities' own approval regime for biotech pr oducts would achieve the European Communities' 
level of protection if the European Communities and its member States allowed it to function as 
designed.  Third, the alternative measure is signifi cantly less restrictive to trade.  If the European 
Communities permitted its approval regime to functi on as designed, biotech products would at least 
be considered for approval on a case-by-case basi s and on the basis of scientific evidence.  
Consequently, biotech products would have an opportunity to be placed on the market, which is 
clearly "significantly less restrictive to trade" th an the across-the-board marketing ban resulting from 
the moratorium . 
(iii) The moratorium violates Article 2.2 
4.210  As the moratorium  is not "based on" a risk assessment contrary to Article 5.1, the moratorium  
is not based on scientific principles and is maintain ed without sufficient scientific evidence, contrary 
to Article 2.2. Similarly, as the moratorium  is more trade-restrictive than required to achieve the 
European Communities' level of prot ection contrary to Article 5.6, it is not "applied only to the extent 
necessary to protect human, animal or plant life or health", contrary to Article 2.2. 
(iv) The moratorium violates Article 5.5 
4.211  
The European Communities' level of protection ap pears to be a "high level of protection".  
However, if this assumption is not correct and th e European Communities' level of protection for 
biotech products with pending applications is that reflected by the moratorium , namely a zero-risk 
level, the European Communities h as violated Article 5.5 of the SPS Agreement . 
4.212  The European Communities has adopted different appropriate levels of protection in several 
"different situations" that can be compared under Artic le 5.5: (i) the level of protection in respect of 
biotech products with pending applications that have been stalled as a result of the moratorium  
("biotech products with pending applications"); (ii)  the level of protection in respect of biotech 
products that were approved for commercia lization prior to the imposition of the moratorium   WT/DS291/R 
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  ("previously approved biotech products"); and, (iii)  the level of protection in respect of novel non-
biotech products such as those produced by conventional plant breeding techniques ("novel non-biotech products"). 
4.213  The European Communities has adopted different appropriate levels of protection in respect 
of biotech products with pending applications, prev iously approved biotech products and novel non-
biotech products.  The European Communities' level of protection in respect of biotech products with 
pending applications appears to be a zero-risk level.  In contrast, the European Communities' level of 
protection in respect of previously approved bi otech products and novel non- biotech products is less 
than zero-risk level in that such products are not subject to an across-the-board marketing ban. 
Moreover, biotech products with pending applicati ons, previously approved biotech products and 
novel non-biotech products are in comparable situa tions because they share "common elements or 
elements sufficient to render them comparable."  The types of risks to human health and the 
environment posed by biotech products with pending applications are the same  as or similar to the 
types of the risks posed by the othe r two identified classes of products.  
4.214  The differences in the European Communities' leve ls of protection for the situations identified 
above are "arbitrary or unjustifiable".  The European  Communities' level of protection in respect of 
biotech products with pending applications (zero-risk level) is higher than the level of protection in 
respect of previously approved biotech products (low  tolerance, but not zero-risk,).  The European 
Communities' own officials admit that there is no sc ientific basis for treating pending applications 
differently from those previously approved.  Likewi se, the European Communities' level of protection 
in respect of biotech products with pending applications  is higher than its level of protection in respect 
of novel non-biotech products (certainly less than zero-risk level) despite the fact that biotech 
products and their non-biotech counterparts pose the sa me or similar types of risks to human health 
and the environment.  Therefore, the difference in le vels of protection is "arbitrary or unjustifiable". 
4.215  The European Communities' measure embodying th e differences in the levels of protection 
set out above, result in  "discrimination or a disguised restriction on international trade."  First, as discussed above, the differences between the levels of protection are "arbitrary or unjustifiable."  
Second, the difference between the levels of prot ection is substantial – for biotech products with 
pending applications the level of  protection is the most stringent possible (zero-risk) whereas for 
previously approved biotech products and novel non- biotech products the level of protection is not 
zero risk.  Third, the moratorium  is not based on a risk assessment, contrary to Articles 5.1 and 2.2.  
Thus, all three warning signals are present.  The difference between the levels of protection also 
exhibits an "additional factor".  The moratorium  disproportionately affects non-EC producers as 
compared to EC producers given that majority of biotech products are produced in the United States, 
Argentina, Canada, and China. 
4.216  The presence of three warning signals and an  additional factor demonstrate that the 
differences between the levels of protection in the co mparable situations set out above, results, in the 
case of biotech products with pending applications , in discrimination or a disguised restriction on 
international trade contrary to Article 5.5. 
(v) The moratorium violates Article 2.3 
4.217  As the European Communities, by maintaining the moratorium , has acted inconsistently with 
Article 5.5, by implication it has also acted inconsistently with Article 2.3. WT/DS291/R 
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  (vi) The moratorium violates Article 8 and paragraph 1(a) of Annex C 
4.218  The moratorium  has led to a systematic failure by the European Communities to undertake 
and complete its approval procedures for biotech pro ducts without "undue delay" , contrary to the first 
obligation of paragraph 1(a) of Annex C.  The approval procedures suspended by the moratorium  are 
"approval procedures" to "check a nd ensure the fulfilment of sanitary or phytosanitary measures."   
4.219  The ordinary meaning of "undue delay" sugg ests that both the reason for the delay and its 
duration are relevant in determining whether the de lay is "undue".  In the context of Annex C, the 
justification for a delay must be consistent with the provisions of the SPS Agreement , in particular, 
that SPS measures must be "based on scientific principles" and not "maintained without sufficient 
scientific evidence" as required by Article 2.2.  In this case, there is no sound justification for 
European Communities' failure to undertake a nd complete the approval procedures for biotech 
products.  Thus, the delay in undertaking and comple ting the approval procedures for biotech products 
is "unjustified". 
4.220  In the case of the moratorium , the delay in undertaking and completing the approval 
procedures for biotech products is caused by a gene ral suspension of those procedures.  An unjustified 
general suspension of an approval pro cedure is on its face an "excessive" delay.  In this case, the fact 
that the general suspension has be en in place for more than 5 y ears compounds the excessiveness of 
the delay. 
(vii) The European Communities has violated Article 7 and Paragraph 1 of Annex B by failing to 
"publish promptly" the moratorium 
4.221  For the same reasons that the moratorium  is an SPS measure, the moratorium is a "sanitary or 
phytosanitary regulation" for the purpose of paragr aph 1 of Annex B.  As the European Communities 
has failed to publish the existence of the moratorium  at all, let alone to do so "promptly," it has acted 
inconsistently with Ar ticle 7 and Annex B. 
5. The product-specific marketing bans  
(a) The product-specific marketing bans  violate the SPS Agreement  
4.222  The moratorium and the product-specific marketi ng bans are closely related, though distinct, 
measures.  The product-specific marketing bans arise as a result of the moratorium being applied to 
individual biotech product applications.  They ar e also proof of the moratorium.  Because the 
measures are closely related, the analysis of the application of the SPS Agreement  and the violations 
of that Agreement with respect to the two class es of measures are based on similar arguments.  
Consequently, the arguments under the moratorium with respect to Articles 5.1, 5.6, 2.2, 5.5, 2.3, 8, 
and paragraph 1(a) of Annex C apply mutatis mutandis to the product-specific marketing bans.  
(b)
 The p roduct-specific marketing bans  violate Article III:4 of the GATT 1994. 
4.223  The product-specific marketing bans  violate Article III:4 by according the s pecific products  
treatment less favourable than the treatment accorded  their respective "like" non-biotech counterparts, 
domestically-grown canola/oilseed rape. 
4.224  First, the product-specific marketing bans  are laws, regulations or requirements affecting the 
internal sale, offering for sale, purchase, distribution and use of the s pecific products .  The product-
specific marketing bans  are inextricably linked to the requireme nt for pre-marketing approval set out  WT/DS291/R 
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  in European Communities' approval legislation.  Th e failure of the European Communities to consider 
or approve, without undue delay, the s pecific products  has affected the "internal sale, offering for sale, 
purchase, transportation, distribution or use" of  these products because those activities require prior 
approval.  As such, the product-specific marketing bans  fall within the scope of  "laws, regulations and 
requirements" as that term is used in Article III:4. 
4.225  Second, the s pecific products  are "like" their respective domestically-grown non-biotech 
counterparts when taking into consideration, in the light of the circumstances of this case, the four 
criteria used to determine "likeness". 
• A comparison of the s pecific products with domestically-grown non-biotech 
canola/oilseed rape reveals that their physi cal differences are minor, and occur only at 
the genetic level.  The specific products  are otherwise physically indistinguishable 
from domestically-grown non-biotech canola/oilseed rape.  For each Specific 
Product , the European Communities has conduc ted science-based risk assessments 
revealing that there is no evidence to suggest that the Specific Products  are less safe 
than their domestic non-biotech counterparts.  If a biotech product has undergone a 
science-based risk assessment, and the conc lusions of that assessment are that the 
product does not pose any greater risk to human  health or the environment than that 
product's non-biotech counterpart, there is no reason to consider that product to be 
different from its non-biotech counterpart in terms of the products' properties, nature and quality, particularly where physical di fferences between the biotech product and 
its non-biotech counterpart can be percei ved only at the molecular level.   
 
• The s pecific products  and their domestic non-biotech c ounterparts are intended to be 
used interchangeably as food, feed and industrial processing materials, as the case may be. 
 
• While Canada agrees that, in principle, consumer tastes and preferences is a relevant 
criterion to the determination of "likeness"  under Article III:4, in this case it should 
be given little practical weight, if any.  No reliable evidence exists regarding the 
consumer tastes and preferences for the s pecific products  as compared to their 
domestically-grown non-biotech counterparts.  In these circumstances, consumer tastes and preferences cannot be considered a reliable indicator of "likeness" given 
the amount of conflicting information publicly available.  Finally, Canada also notes 
that the treatment in question arises in th e course of an approval process intended to 
assess the safety of specific products.  In that  particular context – and consistent with 
the Appellate Body's contextual and case-by-case approach – consumer tastes and preferences should play, at most, a very limited role. 
 
• Lastly, no differentiation is made in resp ect of the tariff classifications between 
biotech products and their non-biotech, conventionally bred, counterparts.   
 4.226  When taken as a whole, the factual evidence relating to each of the four criteria makes it clear 
that the s pecific products  and their domestically-grown non-biotech counterparts must be considered 
to be "like products".  Their physical properties are,  in all essential aspects, virtually identical; their 
end uses are identical; evidence with respect to consum er tastes and preferences is inconclusive, and, 
in this particular context, can onl y be given very limited weight rela tive to the other criteria; and their 
tariff classification is identical.  Based on the foregoing, the Specific Products  are "like" their WT/DS291/R 
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  respective non-biotech counterparts of national orig in for the purpose of Article III:4 of the GATT 
1994. 
4.227  Third, the s pecific products  are accorded treatment less favour able than that accorded their 
respective non-biotech counterparts of national origin.  The product-specific marketing bans  prohibit 
the importation and marketing of each respective s pecific product .  In contrast, domestically-grown 
non-biotech canola/oilseed rape is sold freely on th e EC market.  This cannot be considered as 
providing "equality of competitive opportunities" to the s pecific products , as required by Article III:4.  
Accordingly, the imported s pecific products  have been accorded treatment less favourable than "like" 
products of national origin in viola tion of Article III:4 of the GATT 1994. 
(c) The p roduct-specific marketing bans  violate the TBT Agreement   
4.228  As demonstrated above, the product-specific marketing bans  are SPS measures and are 
therefore covered by the SPS Agreement .  If, however, the Panel finds that the product-specific 
marketing bans  are not SPS measures, then Canada submits, in the alternative , that they are subject to 
the requirements of the TBT Agreement . 
4.229  The product-specific marketing bans  and the relevant EC legislation are "technical 
regulations" and "conform ity assessment procedures", respectively.  The product-specific marketing 
bans  give rise to violations of the following TBT provisi ons: Articles 2.1, 2.2, 5.1.1, 5.1.2, and 5.2.1, 
first part. 
6. The EC member State national measures  
(a) The EC member State national measures violate the SPS Agreement  
4.230  The EC member State national measures  meet both the form and purpose elements necessary 
to be considered SPS measures.  In terms of form, the EC member State national measures  clearly fall 
within the scope of "laws, decrees, regulations, requirements and procedures".  The two French 
measures and the Italian measure are in the form of "decrees".  The Greek measure takes the form of a 
"ministerial decision" and the Austrian measure is an "ordinance", both of which can be equated with 
the types of measures expressly enumerated in paragraph 1 of Annex A of the SPS Agreement .   
4.231  The purpose of the EC member State national measures  is to protect against risks identified in 
paragraph 1(a) through (d) of Annex A of the SPS Agreement .  This can be inferred from the EC 
legislation invoked by the member States as the basi s for instituting such meas ures (safeguard clauses 
of the approval legislation), the measures themselves, and statements by government officials in 
relation to the passage or adoption of such measures. 
(i) The EC member State national measures violate Article 5.1  
4.232  The EC member State national measures  are not "based on" a risk assessment, as required by 
Article 5.1 of the SPS Agreement .  Although the four EC member States imposing the EC member 
State national measures  gave reasons to the Commission when notifying their respective national 
measures , they did not file any supporting scientific ev idence or analysis that  meets the requirements 
of the definition of a risk assessment set out in the SPS Agreement .  While the four EC member States 
pointed to alleged shortcomings in the risk assess ments previously conducted as part of the approval 
process, or raised general concerns with respect to risks to human health or the environment, they did 
not present a comprehensive analysis of the availa ble scientific evidence as to the risks arising from 
these products.  WT/DS291/R 
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  4.233  In contrast, the EC member States where the a pplications for the six products subject to the 
national measures  were originally submitted – and the Eu ropean Communities' scientific committees 
asked to examine the applications – produced va lid risk assessments.  However, these risk 
assessments supported the approval  of the product applications, and, when requested by the 
Commission to review the EC member States' re asons for instituting bans  on the approved products, 
the European Communities' scientific committees rej ected those reasons in each case.  Consequently, 
there is simply no rational relationship between these risk assessments and the EC member State 
national measures . 
(ii) The EC member State national measures violate Article 5.6 
4.234  As discussed in relation to the moratorium , for the purposes of its Article 5.6 argument, 
Canada assumes that the level of protection through out the European Commun ities is that which the 
European Communities has expressed in its legislation.  However, if Canada is mistaken on this point, 
and the level of protection is that which is reflected in the EC member State national measures , then 
Canada advances, in the alternative , its argument with respect to Article 5.5. 
4.235  The EC member State national measures  banning the importation or commercialization of the 
canola/oilseed rape varieties Ms1xRf1 and Topas 19/2, and the corn/maize varieties T25, Bt-11, 
MON809 and MON810, are more trade-restrictiv e than required to achieve the European 
Communities' appropriate level of sanitary or phyto sanitary protection, taking into account technical 
and economic feasibility, contra ry to Article 5.6 of the SPS Agreement .  An alternative SPS measure 
is reasonably available; the alternative measur e achieves the European Communities' level of 
protection; and the alternative measure is  significantly less restrictive to trade. 
4.236  First, it is reasonable to assume that the European Communities' own regulatory regime, and 
in particular the safeguard procedures, constitut es "another measure, reasonably available taking into 
account technical and economic feasibility". Second, the European Communities' level of protection, 
as reflected in the relevant EC legislation, appear s to be a "high level of protection", not zero-level 
risk.  It is reasonable to assume that the Eu ropean Communities' own approval process, which 
approved the products subject to the national measures , was and is designed to achieve the European 
Communities' stated level of protection.  It is also  reasonable to assume that the safeguard procedures, 
if allowed to function as intended, would achieve  the European Communities' stated level of 
protection.  In this case, the approval process and safeguard procedures achieve the European 
Communities' legitimate objective because the biotech products subject to national measures  have 
been marketed for several years elsewhere in th e European Communities, as have other, similar 
biotech products that were approved prior to the moratorium,  without any evidence arising that would 
tend to throw doubt on their safety.  Third, it is in controvertible that a co mplete ban on a product is 
significantly more trade-restrictive than the pre- marketing approval regime under which the products 
subject to the national measures have already been approved.  Accordingly, all three elements of a 
violation of Article 5.6 have been met. 
(iii) The EC member State national measures violate Article 2.2 
4.237  As the EC member State national measures  are not based on a risk assessment, contrary to 
Article 5.1, they are not based on scientific princi ples and are maintained without sufficient scientific 
evidence, contrary to Article 2.2. Similarly, as the EC member State national measures  are more 
trade-restrictive than required to achieve the Europ ean Communities' level of protection, contrary to 
Article 5.6, they are not applied only to the extent  necessary to protect human, animal or plant life or 
health, contrary to Article 2.2. WT/DS291/R 
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  (iv) The EC member State national measures violate Article 5.5 
4.238  The European Communities' level of protection w ith respect to safeguard measures appears to 
be a "high level of protection", but not a zero-level risk.  However, if this assumption is not correct, 
and the level of protection for the six biotech products subject to the EC member State national 
measures  is the level of protection reflected by tho se measures, namely a zero-level risk, then the EC 
member State national measures  violate Article 5.5 of the SPS Agreement . 
4.239  The European Communities has adopted differe nt appropriate levels of sanitary and 
phytosanitary protection in several "different situa tions" that can be compared under Article 5.5: (i) 
the level of protection in respect of the six biotech products subject to the EC member State national 
measures  ("biotech products subject to national measures "); (ii) the level of protection in respect of 
biotech products that have been approved for co mmercialization in the European Communities ("other 
EC-approved biotech products"); and (iii) the level of protection in respect of novel non-biotech 
products ("novel non-biotech products"). 
4.240  The European Communities has adopted different levels of protection in respect of biotech 
products subject to national measures , other EC-approved biotech products and novel non-biotech 
products.  The European Communities' level of prot ection in respect of biotech products subject to 
national measures  appears to be a zero-risk level.  In c ontrast, the European Communities' level of 
protection in respect of other EC-approved biot ech products and novel non-bi otech products is less 
than a zero-risk level. Other biotech products that  have been approved by the European Communities, 
including other canola/oilseed rape and corn/maize va rieties, have not been banned in the four EC 
member States.  Pre-market approval for novel no n-biotech products is not required unless the product 
is to be used as food or food ingredients, in wh ich case, a functioning approval process applies.  
Moreover, biotech products subject to national measures , other EC-approved biotech products and 
novel non-biotech products are in comparable situa tions because they share "common elements or 
elements sufficient to render them comparable."  The types of risks to human health and the 
environment posed by biotech products subject to th e national bans are the same as or similar to the 
types of the risks posed by the othe r two identified classes of products.  
4.241  The differences in the European Communities' leve ls of protection for the situations identified 
above are "arbitrary or unjustifiable".  The European  Communities' level of protection in respect of 
biotech products subject to national measures  (zero-risk level) is higher than the level of protection in 
respect of other EC-approved biotech products (low to lerance but not zero-risk),  despite the fact that 
the actual level of risk present for each of these tw o groups of biotech products is the same. Likewise, 
the European Communities' level of protection in respect of biotech products subject to national 
measures  (zero-risk level) is higher than its level of protection in respect of novel non-biotech 
products (certainly not a zero-risk level) despite the fact that these products exhibit the same risk 
profiles, thus giving rise to the same potential for adverse health effects or risks of the same or similar 
associated biological or economic consequences. 
4.242  
The European Communities' measures embodying th e differences in the levels of protection 
set out above, result in  "discrimination or a disgui sed restriction on international trade."  First, the 
differences between the levels of protection are "a rbitrary or unjustifiable."  Second, the difference 
between the levels of protection is substa ntial – for biotech products subject to national measures  the 
level of protection is the most stringent possibl e (zero-risk) while for other EC-approved biotech 
products and novel non-biotech products the level of  protection is not zero risk.  Third, the EC 
member State national measures  are not based on risk assessments, contrary to Articles 5.1 and 2.2.  
Thus, all three warning signals are present.  WT/DS291/R 
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  4.243  There are two "additional factors" that support a finding of discrimination or a disguised 
restriction on international trade.  First, the five national measures  have a disproportionate impact on 
the producers of these biotech products located outside  the EC member States' territories, as compared 
to producers within the EC member  States.  Second, not only have the EC member States failed to 
produce the requisite risk assessments, they have ignored both the initial risk assessments performed 
by the EC member States where the applications for approval were filed and the opinions submitted 
by the European Communities' scientific committees in  support of those applications, and, later, the 
opinions submitted in response to the invocatio n of the safeguard procedures underpinning the 
national measures . 
(v) The EC member State national measures violate Article 2.3  
4.244  As the EC member State national measures  are contrary to Article 5.5, they also, by 
implication, violate Article 2.3. 
(b) The EC member State national measures violate GATT 1994 
(i) Four EC member State national measures violate Article III:4 
4.245  Four EC member State national measures  (those of France, Italy and Austria; the Greek 
measure is addressed below in relation to Article XI:1) violate Article III:4 by according the biotech 
products subject to those measures treatment less  favourable than the treatment accorded their 
respective "like" non-biotech counterparts, domesti cally-grown canola/oilseed rape and corn/maize. 
4.246  First, the four EC member State national measures  at issue all fall within the scope of the 
meaning of the phrase "laws, regulations or requirements".  These measures clearly "affect" the 
"internal sale, offering for sale, purchase" and "use" of the biotech products in question. 
4.247  Second, the biotech products in question are "like" their respective domestically-grown non-
biotech counterparts when taking into consideration, in  light of the circumstances of this case, the four 
criteria used to determine "likeness": 
• A comparison of the biotech products in question with their domestically-grown non-
biotech counterparts reveals that their physical differences are minor, and occur only at the genetic level.  The biotech produc ts in question are otherwise physically 
completely indistinguishable from the domes tically-grown non-biotech varieties. The 
minor physical differences, in so far as they are relevant at all, cannot be considered to "influence the competitive relations hip between [these] products in the 
marketplace", and cannot therefore detract from an overall finding of "likeness". 
 
• The biotech products in question and thei r domestic non-biotech counterparts are 
intended to be used interchangeably as food,  feed and industrial processing materials, 
as the case may be.  
 
• As with the product-specific marketing bans , while Canada agrees that, in principle, 
consumer tastes and preferences is a releva nt criterion and that the Panel should not 
ignore it, ultimately, it should be given little practical weight, if any, in determining 
the "likeness" of the biotech products in question as compared to their domestically-
grown non-biotech counterparts.  No reliable  evidence exists regarding the consumer 
tastes and preferences for the biotech products in question as compared to their domestically-grown non-biotech counterparts.   In this case, consumer tastes and WT/DS291/R 
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  preferences cannot be considered a reliable  indicator of "likeness" given the amount 
of conflicting information publicly available.   
 
• Lastly, no differentiation is made in respect of the tariff classifications between the 
biotech products in question and their non-biotech counterparts.   
 4.248  When taken as a whole, the factual evidence relati ng to the four criteria makes it clear that the 
biotech products in question are "like" their domestically-grown non-biotech counterparts.  Their physical properties are, in all essential aspects, virtually identical; their end uses are identical; 
evidence with respect to consumer tastes and pref erences is inconclusive; and their tariff classification 
is also identical.  Thus, the second element of the Article III:4 test is satisfied. 
4.249  Third, the products in question are accorded tr eatment less favourable than that accorded their 
respective non-biotech counterparts of national origin.  The four EC member State national measures  
have modified the conditions of competition in th e relevant market to the detriment of imported 
products.  In effect, the biotech products in questi on are completely prevented from competing in the 
French, Austrian, and Italian markets, as comp ared to their domestically-grown non-biotech 
counterparts, which enjoy unfette red access to the same markets. 
(ii) Greece's import ban on Topas 19/2 violates Article XI:1 
4.250  The Greek ministerial decision of 9 September 1998 imposed an import ban on the EC-
approved biotech canola/oilseed rape variety Topas 19/2.  The decision constitutes an "other measure" 
under Article XI:1 of the GATT 1994 and, is inconsis tent with the requirements of that provision. 
(c) The TBT Agreement  applies to the EC member State national measures 
4.251  As demonstrated above, the EC member State national measures  are SPS measures and are 
therefore covered by the SPS Agreement .  If, however, the Panel finds that the EC member State 
national measures  are not SPS measures, then Canada submits, in the alternative , that they are subject 
to the requirements of the TBT Agreement . 
4.252  The EC member State national measures  are "technical regulations": they apply to 
identifiable products; lay down product characteristic s; and compliance with them is mandatory.  The 
EC member State national measures  violate Articles 2.1, 2.2, 2.9.1, 2.9.2 and 2.9.3 of the 
TBT Agreement . 
G. F
IRST WRITTEN SUBMISSION OF ARGENTINA  
1. Introduction 
4.253  The European Communities' system for the approval of biotech agricultural products 
(Directive 2001/18 and its predecessor Directive 90/220 ) or "novel foods" (Regulation  258/97 ) 
requires that, a specific procedure  must be followed before such products can be marketed for 
consumption in the territory of th e European Communities.  The complaint by Argentina is based on 
the following considerations:  (1) Since Octobe r 1998, the European Communities has either not 
considered or has suspended applications for appr oval of all biotech agricultural products under its 
system of approval prior to release or marketing,  and in particular applications for approval of 
products of interest to Argentina;  (2) the Eur opean Communities has caused undue delay by failing to 
consider and/or not completing the processing of applications submitted w ith regard to various  WT/DS291/R 
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  biotech agricultural products;  (3)  some EC me mber States have banned the access to their markets 
for specific biotech agricultural products. 
4.254  In short, the suspension of consideration of th e applications, lack of approval or undue delay 
constitute individual manifestations of a single measu re which forms the subject of this complaint – a 
de facto  moratorium.  Likewise, several specific products of interest to Argentina have been affected 
by suspension or lack of consideration or undue delay, since no decision has been made on their approval to date.  This de facto  moratorium is a measure that has the following characteristics:  (a) it 
has never been set forth in the form of positive legislation – a regulation or directive – but has been 
applied and maintained as a practice in the Eu ropean Communities since 1998;  (b) from 1998 to the 
present, no new biotech agricultural product has be en approved for marketing, which entails the 
systematic suspension of the approval procedures and the failure to consider individual applications 
for authorization or approval of biotech agricultura l products;  (c) the moratorium has affected the 
various applications for approva l of individual biotech agricultural products, thus causing an undue 
delay in the completion of the processing of those applications;  (d) it is not supported by scientific 
evidence;  (e) since 1998 it has mani fested itself in repeated delays and extensions of deadlines on the 
part of the European Communities, under the contin ued pretext of the approval of new legislation: 
amendment of Directive 90/220 by Directive 2001/18, th e need to have additiona l legislation covering 
different aspects and new requirements, etc.;  and (f) reveals an arbitrary and unjustified discrimination against biotech agricultural products.
  The de facto  moratorium implemented by the 
European Communities as well as the bans adopted  by some of its member States are measures 
inconsistent with the provisions of the SPS Agreement , the GATT 1994, or alternatively, the 
TBT Agreement . 
2. Inconsistency with the SPS Agreement  
(a) Inconsistency of the de facto  moratorium with the SPS Agreement  
(i) The de facto moratorium as a measure under the SPS Agreement 
4.255  Argentina considers that the de facto  moratorium constitutes a sanitary and phytosanitary 
measure within the meaning of the SPS Agreement .  For the SPS Agreement  to be applicable to a 
measure, the measure in question has to meet two re quirements:  (a) the measure in dispute must be a 
sanitary or phytosanitary measure;  and (b) the measure must be able to affect international trade.  In 
the opinion of Argentina, the de facto  moratorium meets both requirements.  
4.256  According to the first paragraph of Annex A of the SPS Agreement , for the de facto  
moratorium to meet the first requirement, it must  satisfy two conditions:  (i) it must have as its 
objective at least one of the objectives cited in sections (a) to (d) of pa ragraph 1 of Annex A;  and (ii) 
it must also be reflected in one of the instrume nts cited in the first paragraph of Annex A  The de facto  
moratorium meets both conditions. 
4.257  In Argentina's view, the de facto  moratorium fits the descriptions contained in paragraph 1(a) 
to 1(d) of Annex A. First, the European Co mmunities itself has explicitly acknowledged that the 
purpose of the moratorium is to protect against risks to life and health and to protect the environment.  
The European Communities has also admitted that its policy with regard to biotech agricultural 
products relates to the protection of life and health.  Second, given the fact that the de facto  
moratorium was imposed in the context of the va rious EC regulations, each of which has different 
mechanisms for evaluating the potential damage to hea lth or the environment, it is covered by the first 
paragraph of Annex A. WT/DS291/R 
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  4.258  With regard to the second condition, the Eur opean Communities' moratorium has not been 
introduced through one of the traditional instruments employed by WTO Members to give expression to their decisions, but has been established de facto  by the European Communities.  Nevertheless, the 
European  Communities' own authorities have acknowle dged its existence.  It should also be noted 
that the phrase in the second part of paragraph 1 of  Annex A, "including, inter alia,",  clearly 
indicates that the list that follows is  not intended to be exhaustive.  
4.259  With regard to the second requirement, the de facto  moratorium has had effects on 
international trade.  It should suffice to note th at, since 1998, various biotech agricultural products 
have been denied access to the EC market. 
(ii) The de facto moratorium is in consistent with Article 5.1 
4.260  Article 5.1 establishes the obligation on Member s to conduct a risk assessment.  In this 
particular case, the European Communities is required to conduct at least one of the two types of risk 
assessment mentioned in paragraph 4 of Annex A.  The de facto  moratorium was implemented by the 
European Communities without reference to any t ype of scientific evidence.  Furthermore, the 
de facto  moratorium has been applied even in cases in which the European Communities had received 
favourable scientific opinions from the pertinent scientific committees.  Therefore the European 
Communities has violated Article 5.1, and, in acco rdance with WTO jurisprudence, the violation of 
Article 5.1 also entails a violation of Article 2.2. 
(iii) The de facto moratorium is in consistent with Article 2.2 
4.261  The inconsistency of the de facto  moratorium with Article 2.2 is partly the result of an 
inconsistency between the de facto  moratorium and Article 5.1.  However, Argentina claims that the 
de facto  moratorium violates Article 2.2, irrespective of  its analysis in the light of Article 5.1.  
Article 2.2 requires Members to base their sanitary or  phytosanitary measures on scientific principles.  
The European Communities has no scie ntific basis for, nor scientific evidence that might support, the 
de facto  moratorium.  This lack of any scientific basis means that the moratorium is inconsistent with 
Article 2.2.  Besides, the de facto  moratorium has been maintained for more than five years (1998-
2003) without sufficient scientific evidence.
  Article 2.2 also uses the terms "only to the extent 
necessary," and thus no sanitary or phytosanitary measure can be applied in such a general and 
comprehensive form as the Europe an Communities has done with the de facto  moratorium.  
Moreover, such a broad and general imposition on a ll biotech products contradicts the "case-by-case" 
evaluation which the European Commun ities itself claims has to be upheld. 
(iv) The de facto moratorium cannot be justified under the exception provided for in Article 5.7  
4.262  The Appellate Body in Japan – Agricultural Products II stated that Article 5.7 sets out four 
requirements which must be met in order to adop t and maintain a provisional SPS measure:  (1) the 
measure is imposed in respect of a situation where "r elevant scientific information is insufficient";  (2) 
the measure is adopted "on the basis of available pe rtinent information";  (3) the Member "seek[s] to 
obtain the additional information necessary for a mo re objective assessment of risk";  and (4) the 
Member "review[s] the ... measure accordi ngly within a reasonable period of time". 
4.263  With regard to the first requirement, there is  no basis in this case for using "insufficient 
scientific evidence" as  an excuse for the de facto  moratorium under Article 5.7.  As all biotech 
agricultural products approved by th e European Communities prior to the de facto  moratorium had to 
undergo a case-by-case scientific assessment, the bi otech agricultural products that have not been 
approved since 1998 should also ha ve undergone an approval process that included a risk assessment.  WT/DS291/R 
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  In fact, some of these products received a favourab le scientific opinion recommending their approval.  
With regard to the second requirement, the Eur opean Communities has not adopted this measure 
"provisionally" and has not based its actions on the information available because the European 
Communities has maintained this measure for more th an five years and ignored the scientific evidence 
provided by its own bodies.  With regard to th e third requirement, at no time has the European 
Communities attempted to obtain additional info rmation.  On the contrary, the European 
Communities has only argued that it needs to impose even more requirements on applications, amend 
its legislation, or introduce additional legislati on on another issue.  With regard to the fourth 
requirement, the de facto  moratorium has never been reviewed since 1998. 
4.264  In conclusion, Argentina considers that the de facto  moratorium is not based on scientific 
evidence, and that the European Communities cannot justify this measure under the exception 
provided by Article 5.7.  Consequently, Argentina requests that the de facto  moratorium be found to 
be inconsistent with Article 2.2. 
(v) The de facto moratorium is in consistent with Article 5.5 
4.265  In respect of the first sentence of Article 5.5, the Appellate Body in EC – Hormones has 
indicated that there are three cumula tive elements that must be proven to  claim a violation of this rule: 
(i) application of different levels of protection to different situations;  (ii) arbitrary and unjustifiable 
differences in protection;  and (iii) discrimination a nd a disguised restriction on international trade.  
4.266  With respect to the first element, this element is  made up of two aspects:  "different levels of 
protection" and "different" yet comparable situations.  With respect to the concept of "different levels 
of protection", Argentina notes that the level of protection of the de facto  moratorium is equivalent to 
a "zero risk" level.  With respect to the concept of "different situations", the comparability of different 
situations arises from the fact that such situations  share some common element or elements that make 
a comparison possible.  The European Communities h as applied different levels of protection to two 
"comparable" situations, that is, with respect to the approval for marketing of biotech products before 
and after the de facto  moratorium and with respect to the ne w biotech products and new "non-biotech" 
products, thereby satisfying the first element of th e conditions for the violation of Article 5.5. 
4.267  The second element also needs to be analysed w ith regard to the two comparable situations. 
With respect to the approval for marketing of biotech products before and after the de facto  
moratorium, there is an equivalent level of risk  between the products concerned.  Nevertheless, 
through the moratorium the European Communities h as imposed a level of protection so high that it 
has resulted in an absolute ban on imports without  any scientific evidence.  With respect to new 
biotech products and new "non-biotech" products, the latter can be freely placed on the market within 
the European Communities, except when intended for human or animal consumption, whereas the 
former are affected by the de facto
 moratorium.  In Argentina's opinion, the second element required 
for a violation of Article 5.5 is apparent from the lack of scientific eviden ce in the opinions of the 
relevant EC committees to support these differences in  levels of protection imposed by the European 
Communities. 
4.268  To determine whether a measure meets the third element, in Australia – Salmon  the Appellate 
Body considered three "warning signals" and certain "additional factors".  The  three "warning signals 
were:  (a) the arbitrary and unjustifiable character of the differences in the levels of protection;  (b) a 
rather substantial difference in the levels of protect ion;  and (c) the inconsistency of the sanitary or 
phytosanitary measure with Articles 5.1 and 2.2.  The de facto  moratorium applied by the European 
Communities possesses the three "warning signals" i ndicated above and an additional factor, as 
explained below. WT/DS291/R 
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  4.269  With regard to biotech products before and after the de facto  moratorium, there is a 
substantial degree of difference in  the level of protection accorded by the European Communities, 
without any justification in terms of the level of risk  involved.  In addition, the difference in the levels 
of protection applied is "arbitrary and unjustifiable."  Finally, the European Communities has not 
based the de facto  moratorium on a risk assessment.  With re gard to new biotech agricultural products 
and new "non-biotech" products, the degree of differ ence in the level of protection is considerable 
since it represents a low level of protection for the latter and a level that implies an import ban for the 
former.  In addition, the difference in the level of protection is arbitrary and unjustifiable.  Likewise, 
the de facto  moratorium is not based on a risk analysis and has an adverse effect on new biotech 
agricultural products, the vast majority of whic h are produced outside th e European Communities. 
4.270  Moreover, the de facto  moratorium contains an "additional factor", which is the 
disproportionate impact that the de facto  moratorium has had on producers of biotech agricultural 
products outside the European Communities vis-à-vi s producers within the European Communities.  
(vi) The de facto moratorium is in consistent with Article 2.3 
4.271  As noted by the Appellate Body in Australia – Salmon , once it has been confirmed that the 
de facto  moratorium infringes Article 5.5, that measure will also be inconsistent with Article 2.3. 
(vii) The de facto moratorium is inconsis tent with Article 7 and Annex B:1 
4.272  The European Communities' measure implemented since 1998 is a de facto  measure, which 
was never set forth in any regulation, or published,  thus constituting a violation of Article 7 and 
paragraph 1 of Annex B. 
(viii) The de facto moratorium is in consistent with Article 10.1 
4.273  This provision is mandatory and not simply an obligation to cooperate.  The European 
Communities' suspension of consideration of applica tions, its failure to approve biotech agricultural 
products and the unjustifiable delays in processing constitute a restraint of trade in those products 
amounting to an absolute ban on access, which has ha d and continues to have a considerable impact 
on Argentina, a developing country, in breach of the provisions of Article 10.1.  Argentina, like other 
developing countries, has special needs, in that Argentina is highly dependent on agricultural production and exports.  
4.274  On the grounds set forth above, the de facto  moratorium is inconsistent with the 
SPS Agreement , specifically with Articles 5.1, 2.2, 5.5, 2.3, 7, 10,1 and paragraph 1 of Annex B. 
(b) Inconsistency of the "suspensi on of processing and failure to c onsider individual applications 
for approval of specific biotech agricultural products  of particular interest to Argentina" with 
the SPS Agreement  
(i) Suspension of the approval processes for biot ech agricultural products of particular 
interest to Argentina 
4.275  Since October 1998, the European Communities h as suspended consideration of applications 
for approval of all biotech agricultural products under its approval system.  This suspension is 
apparent from the fact that before the end of 1998, the European Communities had approved a 
considerable number of biotech agricultural pr oducts, whereas since that date the European 
Communities has not approved a single such product .  Among the pending applications stalled at  WT/DS291/R 
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  various stages of the approval process under Direct ive 2001/18 (or, prior to 17 October 2002, under 
Directive 90/220) and Regulation 258/97, are:  GA21 maize, NK – 603 maize, Bt-531 cotton, RR 
1445 cotton, and A2704-12 and A5547-127 soya.  
4.276  The suspension of processing and failure to consid er individual applications for the approval 
of specific biotech agricultural products of particular  interest to Argentina [h ereafter "the suspension"] 
must be also analysed in the light of the SPS Agreement , in accordance with Article 1.1.  Four of the 
enlisted biotech received positive scientific opinion s by the respective EC Scientific Committees, 
favouring their approval. The fifth biotech product did not even get to the stage of risk assessment.   
(ii) The suspension is inconsistent with Article 5.1 
4.277  The following requirements must be met for a sanitary and phytosanitary measure to be 
consistent with Article 5.1:  (i) a risk assessment must exist;  and (ii) the measure must be "based" on that risk assessment.  Argentina considers that the suspension is inconsistent with Article 5.1 because 
neither the member States nor the European Co mmission authorities have complied with the above-
mentioned requirements. 
4.278  With regard to the first requirement, the Eur opean Communities did not undertake any type of 
risk assessment provided by paragraph 4 of Annex A as the basis for the suspen sion.  Therefore, there 
is no risk assessment within the meaning of Article 5.1.  With regard to the second requirement, WTO 
jurisprudence has established that "based on" is ap propriately taken to refer to a certain objective 
relationship  between an SPS measure and a risk assessment.   In the present case, a distinction must be 
made between the two hypothetical cases:  (i) abse nce of such a relationship because no scientific 
assessment was conducted;  and (ii) absence of such a relationship in spite of the fact that a scientific 
assessment was conducted.  In th e first case, the requirements have not been met because no risk 
assessment was performed (the case of soya A2 704-12 and A5547-127).  In the second case, the 
requirements have not been met because the fa vourable risk assessment was not taken into 
consideration as a basis for the suspensi on (as in the case of maize and cotton). 
(iii) The suspension is inconsistent with Article 2.2 
4.279  On the basis of the provisions of Article 2.2 and the WTO jurisprudence with regard to the 
relationship between Articles 2.2 and 5.1, if a san itary measure is not based on a risk assessment as 
required by paragraphs 1 and 2 of Article 5, it can be assumed more generally that the measure is not 
based on scientific principles and that it is bei ng imposed without sufficient scientific evidence .  
Therefore, Argentina maintains th at the suspension does not meet the requirements of Article 2.2. 
(iv) The suspension is inconsistent with Article 5.5 
4.280  The scope of Article 5.5 has been addressed in previous disputes, which have confirmed that a 
complainant must demonstrate the existence of th ree distinct and cumulative elements:  (a) the 
Member that imposed the measure at issue adopted le vels of protection against risks to human, animal 
or plant life or health in various different situations ;  (b) these levels of protection exhibit arbitrary or 
unjustifiable differences in different situations;  a nd (c) these differences result in discrimination or a 
restriction of international trade. 
4.281  The first element consists of two aspects:  "di fferent levels of prot ection" and "different 
situations".  The comparability of different situations  derives from the fact that the situations have one 
or more elements in common that make comp arison possible.  The European Communities has 
established different levels of protec tion in two "comparable" situations , that is different levels with WT/DS291/R 
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  respect to biotech products for products introduced  before and after the moratorium, as well as 
different levels for new "non-biotech" products and new biotech products.  The second element is also 
present in the measure adopted by the European Communities because, gi ven that the levels of risk 
are the same in both comparable situations, it is inc onsistent to apply different  levels of protection as 
has been done by the European Communities.  The third element is also present.  To determine 
whether the third element had been present in Australia – Salmon , the Appellate Body took into 
account three "warning signals" and certain "additional factors".  The suspension applied by the 
European Communities, as well as the moratorium  has the same three "warning signals" and one 
additional factor with respect to  both comparable situations.  
4.282  For the reasons indicated above, the suspension is inconsistent with Article 5.5 of the 
SPS Agreement  with regard both to the treatment of bi otech products before and after 1998, and the 
treatment of new biotech agricultural products as compared with new "non-biotech" products.  
(v) The suspension is inconsistent with Article 5.6 
4.283  WTO jurisprudence indicates that to establish a violation of Article 5.6, it is necessary to 
determine whether there exists another sanitary or phytosanitary measure that:   (1) is reasonably 
available taking into account technical and ec onomic feasibility; (2) achieves the Member's 
appropriate level of sanitary or phytosanitary protec tion;  and (3) is significantly less restrictive to 
trade than the contested sanitary  or phytosanitary measure.  These three elements are cumulative. 
4.284  The first element is present, because the Europ ean Communities' procedures, as applied up to 
1998, constitute a "measure with technical and economic  feasibility" that offers an alternative to the 
suspension of procedures imposed later by the Euro pean Communities.  With  respect to the second 
element, the European Communities' procedures pr esuppose the existence of a level of protection, 
which prior to 1998, served as a basis for the approval of products.  Argentina claims that, if the 
European Communities' level of protection has been  changed, the procedures should also have been 
changed accordingly.  With respect to the thir d element, the previous implementation of the 
legislation allowed the approval and consequent acces s to the market of biotech agricultural products 
of interest to Argentina, whereas the suspension from 1998 to the present has operated as a restriction 
on access to the EC market. 
4.285  For all the reasons set forth above, Argentina maintains that the suspension implemented by 
the European Communities from 1998 to the present is in consistent with Articles 5.1, 2.2, 5.5 and 5.6 
of the SPS Agreement . 
(c) Inconsistency with the SPS Agreement  of the "undue delay" in the processing of individual 
applications for approval of biotech agricultural pr oducts of particular interest to Argentina  
4.286  Argentina will now proceed to demonstrate the inconsistencies between the control, 
inspection and approval procedures of the European  Communities and Article 8 and Annex C of the 
SPS Agreement .  
(i) Analysis in light of the provisions of Artic le 8 and paragraph 1(a), 1(b), 1(c) and 1(e) of 
Annex C 
4.287  In the case of each of the biotech agricultural produc ts of particular interest to Argentina, the 
application of the European Communities' legisla tion has involved violations in terms of the 
obligations under Annex C, and in particul ar paragraph 1(a), 1(b), 1(c) and 1(e).   WT/DS291/R 
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  4.288  As the moratorium is a sanitary or phytosanita ry measure within the meaning of paragraph 1 
of Annex A the European Communities' approval procedures must comply with Article 8 and 
Annex C.  The delay has resulted from the complete suspension of consideration of the applications, 
and ultimately suspension of the application of the control, evaluation and approval procedures 
provided for biotech agricultural products of particular interest to Argentina.  
4.289  The European Communities' legislation sets deadlin es for each of the required steps.  It is 
possible to estimate an approximate length of time within which it seems "reasonable" that the 
procedures could be completed.  The suspension of procedures has resulted in delays that can in no 
case be justified in light of the periods of time s tipulated in the European Communities' legislation, 
and these delays are not based on sufficient scientific evidence.  
4.290  With regard to paragraph 1(a) of Annex C,  although Regulation 258/97 defines a procedure 
that does not differentiate in terms of implemen tation between biotech products and new non-biotech 
products, the undue delay has occurred only in c onnection with the former products.  Another 
example is the treatment accorded to products of this same type before and after the de facto  
moratorium.  With regard to paragraph 1(b), in so me cases the authority failed to determine promptly 
whether the documentation was complete, and in othe r cases it failed to inform the applicant of the 
results of the procedure or of the current stage of the procedure.  Paragraph 1(c) limits information 
requirements to what is necessary for appropriate control, inspection and approval procedures.  The 
European Communities has violated this paragraph by delaying the examination of applications 
submitted or by requiring successive submissions under the terms of subsequent legislation.  
Paragraph 1(e) which establishes the obligation to en sure that the requirements for control, inspection 
and approval of individual specimens  of a product are limited to what is "reasonable and necessary";  
however, the detailed requirements of the European Communities do not appear to meet the criteria of 
reasonableness and necessity.  Moreover, the Eu ropean Communities' own bodies have failed to 
exercise their authority, which failure to act cannot  be deemed reasonable or necessary.  Furthermore, 
when the European Communities was pursuing its policy of replacing Directive 90/220 with its 
successor Directive 2001/18, and even  when the latter Directive was in force, no consideration was 
given to the new applications submitted. 
3. Inconsistency with GATT 1994 
(a) Inconsistency with Article III:4 
4.291  The suspension of the approval processes for bi otech agricultural products of particular 
interest to Argentina is inconsistent with Ar ticle III:4 since the treatment accorded to biotech 
agricultural products is less favourable than that acc orded to "non-biotech" agricultural products.  In 
this regard, Argentina considers that:  (a) the products are "like products" within the meaning of 
Article III:4; (b) the suspension is a "requirement" that affect "the sale, offering for sale, purchase, 
transportation, distribution or use of these products in  the internal market";  and (c) "less favourable 
treatment" has been accorded. 
(i) "Like products" within the framework of Article III:4 
4.292  "Like" does not mean "identical."  Liken ess must be determined on a case-by-case basis, 
using four general criteria, in accordance with GATT/WTO case law.  Therefore, Argentina has 
selected four criteria for examination:  (i) the physical  properties of the products;  (ii) the extent to 
which the products  are capable of serving the same or simila r end-uses;  (iii) the extent to which 
consumers perceive and treat the pr oducts as alternative means of pe rforming particular functions in 
order to satisfy a particular want or demand;  a nd (iv) the international classification of the products WT/DS291/R 
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  for tariff purposes.  The Appellate Body in EC- Asbestos found that each of the criteria should be 
analysed.  Argentina considers that biotech and " non-biotech" agricultural products share these four 
criteria, as explained below. 
4.293  With respect to (i), as a risk assessment has de termined that there is no difference between the 
risks presented by the biotech agricultural products of particular interest to Argentina and those 
presented by their "non-biotech" counterparts, from the standpoint of their physical properties, there is no difference between these products.  With respect to (ii), biotech products and their counterpart 
"non-biotech" products have similar end-uses.  Th e relevant European Co mmunities' scientific 
committees, in evaluating the biotech agricultural pro ducts, confirmed that their end-use could be the 
same as that of "non-biotech products".  With  respect to (iii), in the EC market, the de facto  
moratorium and the suspension have had the effect of barriers to trade and competition.  These types 
of measures can induce or lead to errors in consumer  perception of biotech products.  With respect to 
(iv), there is no difference in tariff classificati on between biotech products and their "non-biotech" 
counterparts.  
(ii) The suspension is a "requirement" affecting "the  sale, offering for sale, purchase, transport, 
distribution and use of products on the domestic market" 
4.294  The suspension is a "requirement".  The GATT/WTO jurisprudence indicated that a 
government action that imposes no legal obligation may be considered a "requirement" under this 
provision.  The suspension is also capable of aff ecting the sale, offering for sale, etc., because it 
affects the conditions of competition.  Th erefore, this second element is satisfied. 
(iii) "Less favourable treatment" is accorded 
4.295  As a result of the suspension, these products are not being approved even though some of 
them have received a favourable opinion from the relevant European Communities' scientific 
committees.  Therefore, this third element is satisfied.  
4.296  On the grounds set forth above, Argentina cons iders that the "suspension of processing and 
failure to consider individual requests for approva l of specific biotech agricultural products of 
particular interest to Argentina" violat es paragraph 4 of Art. III of the GATT 1994. 
4. Inconsistency with the TBT Agreement  
(a) Alternative application of the TBT Agreement  
4.297  As the moratorium constitutes a sanita ry or phytosanitary measure, the SPS Agreement  is 
applicable.  It must be emphasized that the SPS and TBT Agreements  are mutually exclusive, as 
stipulated by Article 1.5 of the TBT Agreement  and Article 1.4 of the SPS Agreement .  Nevertheless, if 
the Panel considers that it should not  analyse Argentina's claim under the SPS Agreement , Argentina 
will argue alternatively under the TBT Agreement . 
4.298
 The TBT Agreement  applies to "technical regulations" and "conformity assessment 
procedures" as defined in Annex 1, paragraphs  1 and 3, respectively.  In this regard, 
Directive 2001/18 (and its predecessor Directive 90/220) and Regulation 258/97 are "technical regulations" pursuant to Annex 1, paragraph 1; and the approval procedures of this same regulation 
constitute "conformity assessment procedur es" pursuant to Annex 1, paragraph 3.  WT/DS291/R 
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  (b) Inconsistency with the TBT Agreement of the application of the European Communities' 
legislation in relation to the approval of biotech agricultural products of particular interest to 
Argentina  
(i) The European Communities' legislation cons titutes "technical regulations" pursuant to 
paragraph 1 of Annex I 
4.299  The Appellate Body in EC – Asbestos  has established the three following criteria for 
determining whether a document fits the definition of "technical regulation" in the TBT Agreement : 
(a) the document must apply to an identifiable product or group of products;  (b) the document must 
lay down one or more characteristics of th e product;  and (c) compliance with the product 
characteristics must be mandatory.  Directive 2001/18 (as well as its predecessor Directive 90/220) and Regulation 258/97 are tec hnical regulations that meet these three requirements. 
4.300  With regard to the first criterion, this requi rement is met since the regulation in question 
refers to "genetically modified organisms", that is , an identifiable group of products.  With regard to 
the second criterion, it is also met since the charact eristic established by the European Communities' 
legislation is the absence of adverse effects on human health and the environment.  The third 
requirement is also met, as a reading of the legislation makes clear its mandatory nature. 
(ii) The procedures under the European Communiti es' legislation constitute conformity 
assessment procedures 
4.301  The procedures under the European Communitie s' legislation constitute conformity 
assessment procedures as defined by point 3 and the Explanatory Note of Annex 1, because the 
requirements therein were established "to determ ine that relevant requirements in technical 
regulations … are fulfilled".  
(iii) The application of the European Communities' legi slation is inconsistent with Article 2.1 
4.302  The way in which the European  Communities has applied its legislation to biotech products 
of particular interest to Argentina is inconsistent w ith Article 2.1.  Since Article 2.1 basically develops 
the same obligations as Article III.4 of the GATT 1994, we refer to the arguments made in the 
relevant part of this submission.  
(iv) The application of the European Communities' legi slation is inconsistent with Article 2.2 
4.303  For the application of a technical regulation to be  consistent with Article 2.2, it must comply 
with three requirements:  (a) pursue a legitimate objec tive;  (b) fulfil that objective;  and (c) not be 
more trade-restrictive than is necessary to fulfil th at legitimate objective, taking account of the risks 
non-fulfilment would create.  The EC regulation is in consistent with Article 2.2 in light of these 
requirements. 
4.304  With respect to the first requirement, the wa y in which the EC regulation has been and 
continues to be applied is inconsis tent with this provision, even though the technical regulations at 
issue include health among their legitimate objectiv es.  With regard to the second requirement, the 
objective of protecting against the potential risks a ssociated with the products has already been 
satisfied by seeking the opinion of the relevant  European Communities' scientific committees.  
However, the European Communities ha s chosen to disregard this scien tific evidence.  With regard to 
the third requirement, the biotech products of partic ular interest to Argentina have already received a 
favourable scientific opinion, which implies that th ese products do not pose any risks that differ from WT/DS291/R 
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  those posed by their "non-biotech" counterparts.  N onetheless, these products have not been approved, 
which is clearly more restrictive than necessar y and creates barriers to international trade. 
(v) The application of the European Communities' legisl ation is inconsistent with Articles 5.1.1, 
5.1.2, 5.2.1, 5.2.2. 
4.305  The application of the European Communities' le gislation is inconsistent with Article 5.1.1 
since it is applied in such a way as to ensure less fa vourable treatment of biotech products than of like 
"non-biotech" products.  The application of the Europ ean Communities' legislation is also inconsistent 
with Article 5.1.2, since it has had the effect of  imposing an absolute ban on imports of biotech 
products and created unnecessary obstacles to internati onal trade.  The obligation of Article 5.2.1 to 
complete the procedures "as expeditiously as possi ble" has not been fulfilled by the European 
Communities, because since 1998 there have been neith er approvals nor processing of applications.  
The way in which the European Communities has a pplied the EC procedures since 1998 fails to meet 
the requirements of Article 5.2.2, since the decision to suspend or postpone the processing of 
applications does not fulfil such obligations as to "proceed as far as practicable with the conformity 
assessment"; nor have the competent EC bodies fulfilled their obligations "promptly." 
(vi) Inconsistency of the application of the Eur opean Communities' legislation with Article 12 
4.306  This provision is part of the "special a nd differential treatmen t" envisaged in WTO 
agreements.  The provision is mandatory and more  than a mere obligation to cooperate.  The 
obligation applies to both the preparation and the a pplication of technical regulations, standards and 
conformity assessment procedures.  
4.307  The suspension constitutes a restriction on trade th at has had effect of an absolute ban on 
access into the EC market of the biotech products of interest to Argentina.  This has had and is still 
having a considerable impact on Argentina, a deve loping country.  Like other developing countries, 
Argentina has special trade, financing and developm ent needs, as Argentina is heavily dependent on 
agricultural production and exports.  Argentina is al so the world's second-largest producer of biotech 
agricultural products, and it ranks firs t among developing countries producers. 
4.308  On the grounds set forth above, we alternatively request that the application by the European 
Communities of its own legislation to biotech agricultu ral products of particular  interest to Argentina 
be declared inconsistent with the TBT Agreement , and specifically with Articles 2.1, 2.2, 5.1.1, 5.1.2, 
5.2.1, 5.2.2 and 12 thereof. 
5. Bans by various EC member States 
4.309  The specific bans that Germany, Austria, Ital y and Luxembourg have applied to the entry of 
biotech agricultural products are inconsistent with WTO rules.  All the products concerned have been 
approved by the relevant EC authorities.  The Eu ropean Communities' legislation allows member 
States to provisionally restrict or prohibit the use and/or sale of a product on their territory.  Several 
member States sought to protect themselves under this  provision.  However, the relevant EC bodies 
have considered these actions by the member States and ruled against these member States' actions.  WT/DS291/R 
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  (a) The member State bans are inconsistent with the SPS Agreement  
(i) The EC member State bans as measures under the SPS Agreement 
4.310  To constitute a sanitary or phytosanitary measur e as defined by Article 1.1, the measure in 
question has to meet two requirements:  (a) the measur e in dispute must be a sanitary or phytosanitary 
measure, and (b) the measure must be able to affect international trade. 
4.311  To be considered as such, a sanitary or phyt osanitary measure must contain two elements. 
First, it must have as its objective at least one of the objectives cited in paragraphs 1(a) to 1(d) of 
Annex A, and second, it must also be reflected in one  of the instruments cited in the second part of 
paragraph 1 of Annex A.  In respect of the first el ement, the sanitary or phyt osanitary objective of the 
measures applied by the member States can be inferre d from the relevant EC legi slation.  With respect 
to the second element, Argentina reiterates its prev ious arguments with respect to the non-exhaustive 
nature of the instruments listed.  The measures applie d by the member States also affect international 
trade, because each and every one of them denies the affected biotech products access to the market of 
member State taking the action. 
(ii) The member State bans are inconsistent with Article 5.1 
4.312  In not having performed the risk assessment estab lished in this provision, the member States 
have not fulfilled their obligations under Article 5. 1 and paragraph 4 of Annex A.  Furthermore, even 
though the relevant European Communities' scientific  committees ruled against them, the EC member 
States have not lifted the bans a nd have violated Article 5.1. 
(iii) The member State bans are inconsistent with Article 2.2 
4.313  The inconsistency of the member State bans with Article 2 arises due to its inconsistency with 
Article 5.  However, the bans also violate Article 2 for the following reasons.  This provision implies 
that a rational relationship must exist between the sa nitary measure and the scientific evidence.  This 
rational relationship clearly does not exist in this cas e, since not only do the EC member State bans 
have no scientific evidence to support them but th ere is even scientific evid ence against them.  The 
bans furthermore conflict with the obligation in Article  2 that a measure be applied "only to the extent 
necessary", and this conflict cannot be jus tified under the exception of Article 5.7. 
(iv) The member State bans are inconsistent with Article 5.5 
4.314  As stated above, three elements must be demonstr ated in order to establish that this provision 
has been violated.  All three elem ents are present with regard to the bans imposed by the EC member 
States.  
4.315  With regard to the first element, while all the products affected by the bans have been 
authorized under the procedures of the Europ ean Communities and the member States concerned 
participated in the approval pro cess, these member States are maintaining their bans.  They claim that 
their measures are justified because they  have a level of protection different
 f r om  t ha t  us ed b y t he  
European Communities for the same products .  However, as these products have the same level of 
risk, the member States are applying different le vels of protection in comparable situations.  
4.316  With regard to the second element, given that the levels of risk are the same, it is inconsistent 
to apply different levels of protection.  Yet this  is what some EC member States have done with WT/DS291/R 
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  respect to biotech agricultural products appr oved under EC procedures and those banned under 
national regulations.  
4.317  An inspection of the actual text of the regulati ons concerned shows that there is an explicit 
restriction on international trade, the third element of  an Article 5.5 violation.  The member State bans 
display the three "warning signals" and one additional factor.  With regard to the "warning signals", 
the difference between the levels of protection applied by the EC member States is "arbitrary and 
unjustifiable."  Furthermore, there is a considerab le and unjustified degree of  difference between the 
level of protection applied to authorized biot ech products and the banned products.  Finally, the 
member States did not base these bans on a risk assessme nt.  With regard to the "additional factor", 
the effect of the bans imposed on the biotechnology -producing countries is significant and adverse.  
Similarly, the bans are not based on a risk assessment  and have an adverse effect on biotech products, 
the vast majority of which originat e outside the European Communities. 
(v) The member State bans are inconsistent with Article 2.3 
4.318  Pursuant to the WTO's jurisprudence, Argentina maintains that as the member State bans have 
been shown to be inconsistent with Artic le 5.5, they also violate Article 2.3. 
(vi) The member State bans are inconsistent with Article 5.6 
4.319  We reiterate our previous assertions with respect to the three requirements under this article. 
These three requirements are present, and thus the ba ns at the level of the EC member States violate 
Article 5.6. 
4.320  With regard to the first element, the me mber States in question could have imposed 
alternative measures to the ex treme of an absolute ban
.  With regard to the second element, an 
appropriate level of protection was established by the European Communities' own regulations as they 
functioned until 1998.  If a member State considered it necessary to redefine the appropriate level of 
protection, it could invoke the "special safeguard", but always subject to a final scientific opinion that 
would justify the different level of  protection.  With regard to the third element, any measure other 
than a ban would have had a less restrictive effect.  The "special safeguard" itself, given its provisional nature, has a less restrictive effect. 
4.321  On the grounds set forth above, Argentina main tains that the bans established by the member 
States are inconsistent with Articles 5.1, 2.2, 5.5, 2.3 and 5.6 of the SPS Agreement . 
(b) The member State bans are inconsistent with the GATT 1994 
(i) Inconsistency with Article III:4 
4.322  The bans of some EC member States infringe  Article III:4 because the above-mentioned three 
requirements identified by the Appellate Body for est ablishing a violation of Article III:4 are met.  
With regard to the first element, we reiterate our previous arguments relating to the suspension.  With 
regard to the second element, the member State ba ns have clearly been implemented through positive 
legislation:  "regulations," "ministerial orders," [and] "decrees" and relate explicitly to restrictions on 
the entry of biotech agricultural products into the respective markets.  With regard to the third 
element, the bans constitute an absolute ban on imports of those products, whereas like "non-biotech" 
products and other biotech products are not subject to  restrictions in the internal markets of these 
member States.   WT/DS291/R 
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  (c) Inconsistency of the EC member State bans with the TBT Agreement   
4.323  It must be emphasized that the SPS and TBT Agreements  are mutually exclusive, as stated 
above.  However, if the Panel concludes th at it should not analyse the matter under the 
SPS Agreement , Argentina argues in the alternative that th e EC member State bans are inconsistent 
with the TBT Agreement . 
(i) The European Communities' legislation for approval of biotech agricultural products 
constitutes "technical regulations" pursuant to paragraph 1 of Annex 1 
4.324  As explained above, the Appellate Body has estab lished three criteria for determining whether 
a document fits the definition of a "technical regulation" in the context of the TBT Agreement .  The 
member State bans are technical regulations that satisfy the three requirements.  The first criterion is met since the bans at issue refer explicitly to specifi c biotech agricultural produc ts.  With regard to the 
second criterion, the Appellate Body in EC – Sardines  ruled that the product characteristics may be 
imposed in positive or negative form.  In the bans at issue, the EC member States have opted for a 
negative description.  The third criterion is also sa tisfied, as a reading of the regulations establishing 
the member State bans clearly indicates their mandatory nature.   
(ii) The bans applied by some EC member States to  specific biotech agricultural products of 
particular interest to Argentina a re inconsistent with Article 2.1 
4.325  Since Article 2.1 basically develops the sa me obligations concerning treatment as in 
Article III:4 of the GATT 1994, we refer to our argume nts in the relevant part of this submission.  
(iii) The application of the European Communities' legi slation is inconsistent with Article 2.2 
4.326  For the application of a technical regulation to be  consistent with Article 2.2, it must comply 
with three requirements:  (a) pursue a legitimate objec tive;  (b) fulfil that objective;  and (c) not be 
more trade-restrictive than is necessary to fulfil th at legitimate objective, taking account of the risks 
non-fulfilment would create.  The EC member States ba ns are inconsistent with Article 2.2, because 
they fail to meet all of these three requirements.  With regard to the first requirement, the member 
State bans are inconsistent because, even though the legitimate objectives of technical regulations 
include health, this does not authorize the EC memb er States to ignore the existing risk assessments of 
specific biotech products in order to achieve poten tially legitimate objectives.  With regard to the 
second requirement, although the objective of protecting against the potential risks associated with these products has already been met by seeking the opi nion of the relevant European Communities' 
scientific committees, the member States did not take  this scientific evidence into account, nor did 
they produce any evidence that might have refu ted those opinions.  With respect to the third 
requirement, although the biotech products of particul ar interest to Argentina had already received a 
favourable scientific opinion and th us the legitimate objective was satis fied, these products have been 
the subject of a ban on imports that is clearly more restrictive than necessary, thus creating barriers to 
international trade. 
(iv)
 The bans imposed byEC member States on specific  biotech agricultural products of particular 
interest to Argentina are inconsistent  with Article 2.9 of the TBT Agreement 
4.327  Article 2.9 applies whenever two conditions ar e present:  (a) whenever there is no relevant 
international standard;  and (b) whenever the t echnical regulation may have a significant effect on 
other Members' trade.  Both conditions are present in  the case of the member State bans in question.  
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  trade, because they are preventing the products fro m entering the markets of the EC member States 
that established the bans. 
4.328  With respect to Article 2.9.1, Argentina has rece ived no notice in any publication at any stage. 
Therefore, Article 2.9.1 has clearly been violated.  The EC member State bans are also inconsistent 
with Article 2.9.2 because no notification has been made to the WTO Secretariat.  Nor was there 
compliance with the requirement in Article 2.9. 4, because Members were not allowed reasonable 
period of time to make comments in writing.  None of the EC member States that established bans on 
products of particular interest to Argentina h as alleged any of the circumstances mentioned in 
Article 2.10 that allow Members to avoi d their obligations under Article 2.9. 
4.329  Thus, should the Panel consider that it is not required to analyse the question under the 
SPS Agreement , Argentina maintains that the identified EC  member States, by instituting bans on 
specific biotech agricultural products, have violated Articles 2.1, 2.2, 2.9.1, 2.9.2 and 2.9.4 of the 
TBT Agreement . 
H. F
IRST WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES  
1. Introduction 
4.330  Argentina, Canada and United States have initia ted these proceedings to challenge what they 
allege to be a general "moratorium" in the European Communities concerning the approval of 
genetically modified organisms (GMO ) and products derived therefrom,  the alleged failure to approve 
a number of specific applications for the placing  on the market of certain GMOs, and certain 
temporary measures adopted by six EC member St ates concerning GMOs that have already been 
authorized in the European Communities.   
4.331  The European Communities wish to underline from the very beginning that it has not adopted 
any general position either in favour or against any of the products subject to these proceedings.  In 
accordance with its regulatory fra mework, the European Communiti es assesses each individual GMO 
on its own merits, in order to evaluate the potentia l benefits and risks of these novel products.  The 
European Communities does certainly not seek to impose its prudent approach on other countries, 
who are free to form their own views on the balance of benefits and risks.  Similarly, the present WTO challenge should not be used as a means for th e complaining parties to impose their approach 
on the European Communities or indeed any other countries, especially at a time where countries 
around the world are still trying to clarify their respective positions on this complex issue.  The 
European Communities can only regret that the comp laining parties have chosen to start a dispute 
settlement procedure based on flawed premises, rather  than to promote international co-operation as a 
means to build a sound international fra mework for addressing the GMO issue. 
4.332  In their submissions, the complaining parti es seek to evade or ignore the whole socio-
political, legal, factual and scientific complexity of  the case.  The complaining parties wilfully ignore 
the social controversies that led to the revision of the European Communities' regulatory framework 
in the period 1998-2001 (a framework that is not  challenged).  They also ignore the scientific and 
regulatory debates at the international level that have taken place over the past years, including the 
process that led to the conclusion of the Cartagena Pr otocol on Biosafety.  The Protocol is based on 
the understanding that the inherent characteristics of  GMOs require them to be subject to rigorous 
scrutiny so as to ensure that they do not cause harm  to the environment or human health, or cause 
socio-economic disruptions.  Moreover, the compla ining parties avoid to discuss the specific steps 
taken in the authorization procedures for GMOs in connection with each indivi dual product, and they 
instead blur the picture referring to the existence of a "moratorium".  Finally, the complaining parties  WT/DS291/R 
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  try to artificially compress this complex dispute into the SPS framework, ignoring the fact that the 
aims of the European Communities' policies on GM Os go beyond the protection against the specific 
risks covered by the SPS Agreement .  The European Communities submits that the Panel will need to 
analyse all the aspects of the case in their full complexi ty before the true simplicity of the dispute can 
be properly recognized.   
4.333  Finally, the European Communities would like to remark that it has chosen to respond to the 
main claims of the three complaining parties through a single first written submission.  The 
submission is not designed to respond to each and every argument of the complaining parties but 
rather to address the most serious of the distortions inherent in the complaini ng parties' presentation of 
the facts and to highlight the fundamental legal er rors on which their cases are constructed.  The 
European Communities will provide a full refutation in subsequent procedural steps, when the 
complaining parties will hopefully clarify the substa nce of their challenge and their claims.  For the 
avoidance of doubt, the European Communities should not be considered to have accepted any factual 
or legal submissions by the complaining parties whic h are not specifically addressed in its submission.  
Nor should the fact that the European Communities responds to the submissions of the complaining 
parties globally be taken as an acceptance that anyone of them may make or develop claims that it has 
not itself made or developed in its pa nel request and first written submission. 
4.334  The European Communities' overall approach  in its first written submission can be 
summarized as follows: 
• the GMOs which are the subject of these pr oceedings each have characteristics which 
are recognized by the international Comm unity to pose potential threats to human 
health and the environment, and they cannot  be treated as "like" or "equivalent to" 
their non-GMO counterparts; 
 
• in addressing the potential risks for each of these GMOs the Community regulatory 
framework has operated on a case-by-case basis, and there has been no formal 
(de jure ) or informal ( de facto ) moratorium in respect of the authorization process or 
any part of it; 
 
• the approach of the Euro pean Communities to the id entification, assessment and 
prevention of risks to human health an d the environment from each of these GMOs 
has been fully consistent with evolving a nd applicable international standards, and 
any finding to the contrary would serious ly undermine the effectiveness of those 
standards, which are premised on the application of a prudent and precautionary approach; 
 
• it is of fundamental importance that the natu re of the action or alleged inaction of the 
European Communities in respect of each of  the GMOs be correctly understood.  The 
WTO agreements contain different provisions  relating to different kinds of measures 
and it is not admissible to re-designate them artificially to allow for the application of 
provisions that the complaining parties find more convenient but which are not in reality applicable; 
 
• 
in particular, in respect of each of the  GMOs the steps which have been taken to 
protect the environment and to conserve biodiversity are reasonable and legitimate, 
are not necessarily sanitary or phytosanitary in  character, and fall in whole or in part 
outside the scope of the SPS Agreement ; WT/DS291/R 
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• to the extent that any steps taken to protect  against risks to human, animal or plant life 
or health in respect of each of the GMOs could be said to be subject to the 
SPS Agreement , there has been no undue delay or breach of any part of that 
Agreement on the part of the European Co mmunities or any member States, and in 
any event such steps are provisionally justif ied on the basis of the insufficiency of 
scientific evidence; 
 
• all steps taken by the European Communities and its member States in respect of each 
of the GMOs are consistent with the TBT Agreement  and the GATT 1994, and in any 
event are justified in accordance with Article XX of the GATT 1994. 
 
2. Factual part 
(a) Scientific background 
4.335  A genetically modified organism (GMO) is an organism in which the genetic material has 
been altered in a way that does not occur naturally by mating and/or natural recombination.  Contrary 
to conventional methods of altering genetic material , genetic modification allows for the crossing of 
natural species barriers, or for the transfer of single or few genes instead of whole genomes.   
4.336  Techniques of genetic modification include the u se of the bacteria as the delivery mechanism, 
micro-injection and high velocity ballistic delivery.   All techniques have in common that they are 
actually not able to control where the foreign gene  will be inserted and whether that insertion will be 
stable. 
4.337  Development of GMOs began in 1970 and has si nce then has rapidly evolved in what could 
be called generational steps.  First generation GMOs are mainly crops with either herbicide-tolerant 
traits or insecticidal properties or the combination of both (so-called stacked genes).  More recent generations, most of which are not yet being commerc ialised include nutritionally enhanced crops and 
crops that are used for industrial or medical purposes (so-called phytofarming).  The European 
Communities recognizes the potential benefits of the new technology, and subscribes to the approach 
taken in the preamble to the Biosafety Protocol, which states that "modern biotechnology has great 
potential for human well-being if developed and used with adequate safety measures for the 
environment and human health". 
4.338  Research so far has identified a number of pote ntial harmful effects resulting either from the 
very process of genetic modification itself (wrong or unstable insertion) or from the successfully 
modified end product.  Potential harmful effects on human health include toxicity, allergenicity, 
horizontal gene transfer and antibiotic resistance.  Potential harmful effects on the environment, in 
addition to the above (to the extent they can affect animal or plant life or health) include non-target effects, invasiveness and development of resistan ce, unintended effects arising through GMO related 
management practices, and effects on biodiversity.  These effects depend on the nature of the specific 
GMO in question and on the intended use.  Where GM Os have been released into the environment, 
such harmful effects might be irreversible.  The need for a pre-marketing case by case assessment, thus, is obvious.  In addition, research has only st arted to identify these issues and long term effects 
are largely unknown.    WT/DS291/R 
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  (b) International and comparat ive regulatory arrangements 
4.339  In light of these risks, governments around the world, since the first commercialisation of 
GMOs in the early nineties, have started to address the question of how to regulate GMOs.  
Regulatory approaches range from complete bans to "laissez faire." Most, however, consist in setting 
up an approval system specific to GMOs, based on a case-by-case detailed risk assessment.  Often such systems are based on a precautionary approach , and decisions are sometimes made dependent on 
considerations other than scientific factors, such  as, for instance, socio-economic considerations.  
Furthermore, approval may be subject to post-market  surveillance requirements.  Given the constant 
evolution of the science on GMOs, regulatory a pproaches are under constant review in many 
countries. 
4.340  With a view to seeking international consensus governments have also addressed the issue in 
various international fora.  Most importantly, afte r long and difficult negotiations, they have adopted 
the Cartagena Protocol on Biosafety in 2000 (103 si gnatories including Canada and Argentina).  The 
Protocol addresses the safe transfer, handling and u se of living modified organisms that may have 
adverse effect on biodiversity.  It establishes an Advance Informed Agreement (AIA) for imports of 
living modified organisms (LMOs) intended for deliber ate release into the environment, incorporates 
the precautionary principle and details info rmation and documentation requirements.   
4.341  In addition, work on specific issues related to  GMOs is ongoing in specialized agencies and 
other international bodies or organisations such  as Codex Alimentarius, FAO, WHO, UN, OECD, 
ASEAN and the African Union.  The guidance docum ents established by these fora, in particular, 
recognize the need for a case-by-case decision on individual GMOs based on a scientific risk 
assessment and on risk management considerations. 
4.342  Against this background the European Communitie s submits that it is not plausible to argue 
that GM products are – or should be treat ed as – equivalent to non-GM products.   
(c) The European Communities ' regulatory framework 
4.343  The evolution of the European Communities' ow n legislative framework on GMOs has to be 
seen against this background.  Legislation on the re lease into the environment of GMOs has been put 
in place as early as 1990 with the adoption of Direc tive 90/220, with sector specific legislation, and 
most specifically, Regulation 258/97 on Novel F oods (including GM foods), following later.  The 
above described developments in scientific research  and in international regulatory standards have 
soon made it necessary for the European Communities to  review its legislation.  The review process 
which started in 1998 has led to the replacement of  Directive 90/220 through Directive 2001/18 and to 
the adoption, most recently of further legislation concerning specifically GM food and feed and traceability and labelling. 
4.344  Directive 90/220 (and its successor Directive 2001/18) as well as Regulation 258/97, which 
are the legislative acts relevant to the issues raised  in this case, establish approval procedures for the 
release into the environment of GMOs and for th e marketing of GM food.  Approval granted on the 
basis of these acts is valid throughout the Europ ean Union.  The procedures provide for case-by-case 
decisions based on scientific risk assessments.  Esse ntially, the assessment takes place at two levels 
and in two stages: Once an application is lodged in  a EC member State, its authorities ('the lead 
competent authority') make an initial assessment.  If it is positive, the dossier is sent up to the 
Community level from where it is circulated to all other member States.  If all agree with the initial 
assessment, the lead member State grants final consent.  If objections are raised, and no agreement 
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  committee (nowadays, the European Food Safety Authority) before presenting a proposal for a 
decision to a so-called Regulatory Committee cons isting of member States representatives.  If the 
proposal does not get a qualified majority in this  Committee, the Commission presents a proposal to 
the Council of Ministers for adoption (or rejection) by qualified majority.  If the Council does not act 
within three months the Commission adopts the d ecision.  While approval is valid throughout the 
European Union, the legislation provides for the possibility for member States to adopt safeguard 
measures prohibiting the release/marketing in their own territory.   
4.345  As mentioned above, the rapid developments  in science as well as in the international 
regulatory debate, made it necessary for the Eur opean Communities to substantially revise its 
legislation.  Directive 90/220, in particular, lack ed harmonised standards fo r the risk assessment and 
provisions on post-market monitoring and traceability.  The proposal for a revised Directive, which 
the Commission presented in 1998, went through the legislative procedure of co-decision by the European Parliament and the Council, an elabor ate process of negotiation between the two bodies, 
which resulted in the adoption of Directive 2001/18 in the year 2001.  The Dire ctive entered into force 
in October 2002.  It provided that pending applicatio ns were to be re-subm itted in an up-dated form 
replying to the new requirements by January 2003. 
4.346  To the extent that the applicants for authorizations under Directives 90/220 and 2001/18 and 
Regulation 258/97 are dissatisfied with any act or failure to act of the national authority of a member State or of a Community institution they are free to  bring proceedings for administrative or judicial 
review of such acts.  In respect of the 43 produc ts which are the subject of these WTO proceedings 
the European Communities is aware of proceedi ngs brought in respect of national measures 
(safeguard provisions) only in the case of Italy.  No  applications have been made to the European 
Court of Justice challenging any actions or alleged failure to act of the Community institutions in 
respect of any of the products. 
(d) Individual product applications 
4.347  A detailed examination of each of the product a pplications listed by the complaining parties 
shows that, contrary to the complaining parties' cl aims, there has never been  a "general suspension" 
and the individual applications have not been stalle d at any moment.  As the detailed chronologies and 
exhibits submitted by the European Communities pr ove, no single pattern can be identified and each 
single product has merited and merits an analys is on its own.  The evaluation processes have 
continued through the past years,  with the EC authorities at national and European Communities' 
level trying to take account of the changing le gislative and regulatory framework as well as the 
evolving scientific debate in trea ting the pending applications.   
4.348  Each application has thus its own individual history, with assessmen ts being conducted and 
concerns being raised, in a process that invol ved exchanges between co mpetent authorities and 
between the authorities and the appli cant companies.  It should be noted that many applications had to 
be re-submitted under Directive 2001/18 by Janua ry 2003 (which is not challenged by the 
complaining parties) for a fuller assessment.  Also, ma ny of the applications listed by the complaining 
parties have been withdrawn or not re-submitted, us ually for purely commercial reasons.  It is worth 
mentioning that in some cases the applicants did not  want to be associated with the GM products 
anymore. 
4.349  All pending applications have in the past been  subject to requests for additional information 
of varying kinds.  Often requests were related to in sufficient data in the dossi er to allow for a proper 
risk assessment as required by the existing legislatio n.  In quite a few cases, however, some requests 
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  the time, and, in particular, to monitoring and traceability issues.  Such requests were made in 
anticipation of the new legislation to be adopted  and were based on voluntary commitments on the 
applicant's side (so-called "interim approach").   
4.350  On the applicants' side, in many cases, considerab le delays have been taken in replying to 
requests for additional information.  These delays ma y also have to be seen against the background of 
the permanent structural changes on the production side of the market.  Mergers, acquisitions, transfers of production rights have taken place, changi ng often the protagonist of the application.  This 
caused sometimes substantial time delays  in pursue of the procedure.   
4.351  Since the entry into force of Directive 2001/ 18, the individual applications are now being 
processed smoothly and are moving through the differ ent instances of the procedures as described 
above.  In some cases, requests for additional inform ation have been put to th e applicants related to 
insufficient data (as required by the legi slation) in the application dossier.   
3. Legal arguments 
(a) Preliminary issues 
4.352  The European Communities has considerable difficulties with the complaining parties' 
identification and characterization of the challe nged measures and with their arguments on the 
applicable law. 
4.353  As regards the identification of the measures, all three complaining parties are alleging the 
existence of a "general moratorium" affecting all GMOs, as well as the existence of a separate 
measure consisting in "suspensions " affecting certain specific GMOs.  Aside from the fact that the 
complaining parties fail to explain how the Eur opean Communities would be applying simultaneously 
those two separate measures, they tr y unsuccessfully to identify an inst rument or other text in which 
such a "moratorium" is brought into effect.  In  reality, the European Communities does not impose 
nor does it intend to impose any "moratorium" on GMOs, let alone a ban.  As the complaining parties' 
case concerns the conduct of approval procedures (i.e.  the delay in completing such procedures), the 
relevant WTO rules should be those obligations that  concern procedures rather than those that deal 
with the adoption of substantive measures.  Once th e acts complained of are correctly characterised as 
delay, it is clear that they cannot amount to a ban.  The fact that GMOs cannot be marketed until approved is an intrinsic feature of the Europ ean Communities' GMO legislation, which is not 
challenged in these proceedings, and it has to be clea rly distinguished from allegations about delays in 
the assessment procedures. 
4.354  As regards the applicable law, the Eur opean Communities does not agree that the 
SPS Agreement  is the only relevant agreement for the pur poses of this dispute.  The scope of the 
SPS Agreement  is limited to measures adopted to prevent an exhaustive list of narrowly defined risks.  
To the extent that a domestic measure is aimed at th e protection against other risks, or that it pursues 
other different objectives, the SPS Agreement  is not applicable.   
4.355  The issues arising out of the existence of GMOs go far beyond the risks envisaged and 
regulated by the SPS Agreement .  A rigorous interpretation of the definitions in Annex A.1 of the 
SPS Agreement  unequivocally shows that measures addressi ng issues such as antibiotic resistance or 
changes in the ecological balance are not among the measures that the SPS Agreement  intends to 
discipline.  Since the European Communities, throug h its actions, aims at the fulfilment of objectives 
that go beyond the specific situations that determine the applicability of the SPS Agreement , such WT/DS291/R 
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  Agreement does not provide a sufficient legal fra mework for the examinat ion of the European 
Communities' behaviour. 
4.356  The above conclusion does not imply that the SPS Agreement  is irrelevant for the present 
dispute, nor it means that the European Commun ities' behaviour cannot be scrutinised under any 
WTO rule.  The European Commun ities is of the view that the SPS Agreement  is relevant in relation 
to some of the issues that are examined by EC authorities in the course of GMO approval procedures 
(including safeguard mechanisms).  However, the SPS Agreement  cannot exclude the applicability of 
other WTO rules to different, non-SPS, aspects of the challenged measures.  GATT 1994 and, where 
relevant, the TBT Agreement , can be used to examine tho se other aspects of the European 
Communities' behaviour.  In that regard, it should be  noted that the effect of Article 1.5 of the 
TBT Agreement  is to exclude the cumulative application of the TBT and the SPS Agreements  to 
measures that squarely fit in the definitions of Annex A.1 of the SPS Agreement .  Article 1.5 certainly 
does not imply, in the case of a composite measure that is only partly  pursuing SPS aims, that the 
TBT Agreement  is entirely irrelevant and that a narrow examination of one single element of the 
measure under the SPS Agreement  can lead to a conclusion on the WTO-consistency of the measure 
as a whole.  Clearly, any measure or part of any measure adopted for reasons that fall outside the scope of the SPS Agreement  cannot be inconsistent with that agreement. 
4.357  The European Communities therefore claims th at the measures subject to these proceedings 
must be revised separately under more than one WTO agreement, according to their nature and aims, 
before reaching a conclusion on their overall consis tency with WTO obligations.  Furthermore, the 
European Communities claims that the general exce ptions contained in Articles XX and XXI of the 
GATT 1994 also apply to the TBT Agreement . 
4.358  Finally, as a general remark, the European Co mmunities would like to stress the importance 
of international regulatory acts in the field, in par ticular the Cartagena Biosafety Protocol.  According 
to the Appellate Body, the rules of customary law "c all for an examination of the ordinary meaning of 
the words of a treaty, read in their context, and in the light of the object and purpose of the treaty 
involved".  The Biosafety Protocol can assist the Pa nel in the process of interpreting WTO rules, in 
accordance with the Appellate Body findings in US – Shrimp . 
(b) The product-specific delays 
(i) The measure 
4.359  At the outset, the European Communities would unde rline that nineteen of the applications 
listed by the complaining parties have been wit hdrawn or abandoned.  The European Communities 
submits that the Panel should consider the claims  concerning those applications as inadmissible.  
Findings on those specific applications cannot serve any useful purpose, as required by Article 3 of 
the DSU, since the European Communities cannot take any action with regard to those product 
applications.   
(ii)
 SPS Agreement 
4.360  The European Communities submits that among the various provisions which the 
complaining parties allege to have been violated under the SPS Agreement  only Article 8 together 
with Annex C can be applied to the facts of the cas e, to the extent that the European Communities' 
approval procedures address risks comi ng under point 1 of Annex A of the SPS Agreement .  The 
alleged failure to deal with certain product applicati ons is not an SPS measure, the nature of the latter 
(as defined in Annex A point 1) requiring the existe nce of an act, however formal or informal.  The  WT/DS291/R 
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  alleged failure to reach a final decision on certa in product applications, therefore, can only be 
challenged as the application  of an SPS measure, but not as an SPS measure itself.   
4.361  Only Article 8 and Annex C address issues of application  of an SPS measure (with the latter 
being the approval system as established by the Eu ropean Communities' GMO legislation).  All other 
violations alleged by the complaining parties relate to an SPS measure as such.  Given that the alleged 
failure to act does not constitute an SPS measure, the provisions invoked by the complaining parties 
are not applicable. 
4.362  There is no violation of Article 8 and the various provisions of Annex C cited by the 
complaining parties, and, in particular, there have not been any "undue delays" within the meaning of 
Annex C point 1 (a).   
4.363  The concept of "undue delays" is to be interp reted in accordance with the general rules of 
international law on treaty interpretation and can be u nderstood to be referring to a period of time lost 
by inaction or inability to proceed wh ich is unjustifiable.  It is clear also that the meaning of the words 
"undue delay" cannot be inferred from the domestic legislation of WTO Members.  It is not the 
purpose of the SPS Agreement  to transform any departure from national legislation to the level of a 
breach of international law.  Argentina's and the United States' argument, therefore, that "undue 
delay" can be inferred from the alleged fact that  procedural delays set out in the European 
Communities' legislation have not been respected, must be dismissed. 
4.364  On the basis of the facts outlin ed above it is clear that the approval process for individual 
applications in question, has not b een "generally suspended" (as the complaining parties allege) at any 
time since 1998.  Where delays have occurred in individual instances due to requests for additional 
information such delays (to the extent they are, at  all attributable to the European Communities) have 
been justified by the nature of these requests.   
4.365  On a level of principle, the European Commun ities submits that it is legitimate to request 
additional information necessary for the completion of a risk assessment and/or compliance with 
certain standards of risk management or risk communication as they have been established by a 
regulator and as they apply to the given product in question.  That principle applies generally to any 
product that goes through an approval or inspection pr ocedure designed to ensure  that this product is 
safe.  It applies a fortiori  when the product in issue is based on a new technology which is generally 
untried and untested and which is recognized by th e international Community to have characteristics 
which inherently require prudence and caution. 
4.366  Such requests do not become "illegitimate" if a nd because they are not expressly set out in the 
legislation applicable at the time of the applica tion nor do they become "illegitimate" where they are 
put in the form of a legislative requirement to re -submit an up-dated dossier (a requirement that has 
not been challenged by the complaini ng parties in their panel requests). 
(iii) GATT 1994 – Article III:4 
4.367  Canada and Argentina have i nvoked Article III:4 of the GATT 1994 in relation to the alleged 
product specific delays.  The European Communities di sagrees that its conduct with regard to specific 
product applications constitutes a breach of said ar ticle.  First of all, the measures challenged by 
Canada and Argentina are alleged delays in dealing with specific requests for approval.  These 
measures are not in themselves "laws, regulations or requirements".  Second, a violation of Article III 
can only occur if it can be shown that imported pro ducts are treated less favourably than domestic like 
products.  The European Communities has not taken more time to authorize the importation of the WT/DS291/R 
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  GMOs at issue than to authorize their domestic cu ltivation or processing.  Therefore, there is no 
difference in treatment.  Third, conventional, non- GM products are not subject to the same approval 
procedure, and the international community has recognized that GM products require their own, 
distinct authorization procedure.  As a result, the only "like" products for comparison can be GM 
products and not their non-biotech counterparts. 
(c) The "general suspension" 
(i) The measure 
4.368  The complaining parties seem to argue is that  in the European Communities there exists an 
alleged practice of suspending the consideration of applications and approvals, in the form of a 
repeated pattern of systematic behaviour.  Such a practice is not based on any document even informal 
or non binding in nature.   
(ii) There is no general suspension 
4.369  The European Communities has shown through ex tensive factual evidence that there is no 
general suspension and there has ne ver been one any at any point in  time.  There is no consistent 
practice in respect of all the applications as a w hole.  Each has been taken on its own merits. 
4.370  The "evidence" put forward by the complaining parties regarding the absence of final 
approvals in the past 5 years is incorrect, inconclusi ve and inconsistent.  It is incorrect, because (as is 
uncontested) GM products have been authorized to be put on the market during this time.  It is 
inconclusive, because the absence of  an approval does not mean that an approval process has been 
suspended.  It is inconsistent, because the Unite d States only refers to a limited number of products 
(instead of all) and only to an alleged situation in the past (and not to the present).  Canada, on its part, 
cannot reconcile its presentation of processes being "stalled" with the plain fact that dossiers are 
moving through the different instances.   
4.371  The "evidence" of various "statements" fro m different sources presented by the complaining 
parties is mostly irrelevant and otherwise inc onclusive.  On the basis of WTO jurisprudence on 
statements as evidence, only official statements of the European Communities could at all be relevant.  
Those statements of the European Commission which come closest to being "official statements," do 
not announce nor confirm a suspension of the approval processes. 
4.372  In any event, even assuming that on the basis of that "evidence", and in spite of the actual 
facts, it could be said that there was in the past a systematic suspension of the approval process, such a 
pattern or practice would not as such c onstitute a challengeable measure under the WTO Agreement . 
(d) The EC member State safeguard measures 
(i) SPS Agreement 
4.373  As regards the measures taken by the EC member States, which affect GMOs already 
authorized in the European Co mmunities, these are provisional measures pending a full assessment at 
European Communities' level, which will eventually lead either to a modification of the Community-
wide authorization or a termination of the nationa l safeguard measures.  The safeguard measures are 
therefore provisionally and temporary in their ch aracter.  This is confirmed by the measures 
themselves, by the explicit terms of the legal provisions on which they are based (Article 16 of  WT/DS291/R 
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  Directive 2001/18 and Article 12 of Regulation 258/97) and finally by the European Court of Justice 
(case C-236/01).   
4.374  Consequently, these measures should be reviewed under Article 5.7 of the SPS Agreement  to 
the extent that they are falling under the SPS Agreement .  Indeed, Article 5.7 is specifically designed 
to discipline a subset of SPS measures, namely te mporary measures, to the exclusion of other SPS 
provisions wrongly invoked by the complaining parties such as Article 5.1.   
4.375  Far from being an exception, Article 5.7 is th e relevant provision to examine temporary 
measures.  All three complaining parties have failed to assert in their panel requests that any of the 
measures adopted by the member States are inconsistent with Article 5.7 of the SPS Agreement .  
Therefore, their claims on the safeguard measures must  be dismissed.  Moreover, there is no burden of 
proof on the European Communities concerning the four conditions in Article 5.7.  In any event, the 
European Communities contends that the four conditi ons are met: first, the scientific evidence was 
insufficient; second, the member Stat es based their measures on available pertinent information; third, 
member States and the European Communities are engaged in an ongoing process by which they are 
seeking to obtain the additional information necessary for a more objective assessment of the risk; and 
fourth, the measures are subject to a review within a reasonable period of time.   
4.376  As said before, Article 5.7 of the SPS Agreement  contains specific rules regarding provisional 
measures, and it is by reference to these rules, not  the rules in Article 5.1, that the member State 
measures must be assessed.  However, should Articl e 5.1 be considered relevant, the European 
Communities stresses the importance of the terms "a ppropriate to the circumstances" that qualify the 
obligation to base measures on a risk assessment.  Those terms logically imply a certain degree of 
flexibility, especially in cases where scientific knowledge is still developing and the potential risks being assessed are important.  Furthermore, SPS measure  must be "based on" (not "conform to") a 
risk assessment, and a given risk assessment may reasonably support more than one possible SPS 
measure.  As a matter of fact, there is no obligation for WTO Members to follow mainstream 
scientific opinions. 
4.377  The complaining parties' claims under Articles 5.6 and 5.5 of the SPS Agreement  must also be 
rejected.  As regards the former Article, the comp laining parties' arguments are based only on the 
basis of a wrong assumption about the appropriate level of protection that is being sought.  
Furthermore, it is self-evident that the necessity of  the measure would have to be judged by reference 
to the insufficiency of scientific  evidence, and the reasonable peri od of time necessary.  As regards 
Article 5.5, its application is effec tively excluded by Article 5.7 of the SPS Agreement  and, in any 
event, the European Communities has not behaved in an arbitrary manner or made unjustifiable distinctions.  The differences in treatment allege d by the complaining parties are between entirely 
different  GMOs or between GMOs and conventional pr oducts and are not arbitrary or unjustified. 
4.378  Finally, since the complaining parties' claims under Articles 2.2 and 2.3 of the SPS Agreement  
are in fact derived from their claims under Articles 5.6 and 5.5, they must equally be dismissed. 
(ii) The GATT 1994 
4.379  Argentina and Canada allege that the member  States measures violate Article III:4 of the 
GATT 1994.  The European Communities rejects such claims as unfounded.  The prohibitions 
established by the member States, which are no more  than temporary territorial exceptions to the 
original EC authorizations, cannot but apply in  the same way to GMOs which are domestically 
produced or processed within the Co mmunity territory and to those th at are imported.  A "treatment 
less favourable" for imported than for domestic products is thus intrinsically impossible in this case.  WT/DS291/R 
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  Furthermore, as mentioned above, the European Communities considers that in the context of 
marketing approval legislation, the "like" product has to be a product which is similarly subject to the 
approval procedure.  Choosing a category of like product which is outside the approval procedure 
amounts to attacking the ratio of the distinction op erated by the legislation, which is not being 
challenged in these proceedings.  Moreover, the Eu ropean Communities also contests that the "like 
products" comparison can be carried out on the basis of such broad categories and generic terms such 
as "respective domestically-grown no n-biotech counterparts" and "imported biotech products and 
'non-biotech' domestic products", without any proof be ing provided on the specific properties, nature, 
quality, end-uses, consumers' tastes and ha bits of each specific product at stake.   
4.380  Canada also contends that the Greek measure is  in breach of Article XI:1 of the GATT 1994.  
It is however clear that the nature and aim of the Greek measures does not differ from those of the 
other national measures called into question by Ca nada.  Indeed, the aim pursued by Greece is the 
temporary restriction of the introduction or use of  a given GMO within its territory, no matter the 
origin of the product. 
(iii) The TBT Agreement 
4.381  Finally, no TBT violation can be found in relation to the challenged member States measures.   
4.382  The European Communities considers that th e member State measures are not technical 
regulations within the meaning of the TBT Agreement .  The definition of "technical regulation" in the 
Agreement refers essentially to a normative  type of measures, that is, one that lays down in relatively 
abstract terms certain rules, with which products  must comply.  However, each member States 
measure is in fact an individual administrative act  relating to a specific product from a specific 
applicant or manufacturer.  Each of those measures amounts to a simple ban on a product in its 
natural state , and they do not therefore contain "product characteristics" in the general and abstract 
sense in which that term is used in Annex 1, point 1 of the TBT Agreement.  
4.383  In any event, neither Article 2.1 nor Article 2.2 of the TBT Agreement  would provide support 
to the complaining parties' case.  On the one hand, even if non-GM products could be considered to be 
"like" a GM products ( quod non ), Article 2.1 of the TBT Agreement  can only apply to differences in 
treatment between products that are, by their natu re, susceptible of being covered by the technical 
regulation in question.  On the other hand, th e assertion that the member States measures do not 
contribute to achieving their objectives is unsubstantia ted and it fails to take into account the review 
of the relevant EC legislation and the parallel review  of the EC authorizations concerning the products 
affected by the member States measures. 
(e) The special and differential treatment claims 
4.384  The European Communities does not accept that there is violation of the "special and 
differential treatment" obligati ons in Article 10.1 of the SPS Agreement  and Article 12 of the 
TBT Agreement .  Argentina deduces those violations me rely from the alleged breach of other 
provisions of the agreements, which the Europe an Communities contests.  Furthermore, trade 
statistics show that imports from developing countri es that have widely adopted GM agriculture have 
not decreased.   
(f) Article XX of the GATT 1994 
4.385  Last but not least, the European Communities s ubmits that if the Panel found any of the 
challenged measures to be inconsiste nt with any of the provisions invoked by the complaining parties,  WT/DS291/R 
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  those measures should be found to be justified under Article XX of the GATT 1994 because (1) they 
come under one of the particular exceptions of paragra phs (b), (d) or (g) and (2) they do not constitute 
an arbitrary or unjustifiable discrimination between  countries where the same conditions prevail or 
disguised restrictions on international trade. 
4. Conclusion 
4.386  In conclusion, the European Co mmunities requests the Panel to reject the complaining parties' 
claims and to find that: 
• The delays in the examination of the a pplications which are the subject of these 
proceedings are not in violation of the SPS Agreement , the TBT Agreement  or the 
GATT 1994; 
 
• There is no general suspension of the pro cess of authorizing GMOs and GM products; 
 
• The EC member States national measures are not in violation of the SPS Agreement , 
the TBT Agreement  or the GATT 1994. 
 
I. F
IRST ORAL STATEMENT OF THE UNITED STATES  
1. General comments on European Communities' first written submission 
4.387  First, much of the European Communities' subm ission addresses issues that have little, if any, 
connection to the legal questions in dispute in  this proceeding.  The European Communities' 
submission stresses the European Communities' vi ew that biotechnology involves complexity.  
However, the European Communities does not claim, and indeed could not claim, that any of the 
scientific issues discussed in its background section justified either a general moratorium or the 
product-specific moratoria.  Instead, the European Communities claims that there was no moratorium 
at all.  To make this claim, the European Co mmunities asks us to believe that the European 
Communities' own highest officials misunderstand the European Communities' approval system, and 
that the failure to approve any biotech produc ts between October 1998 a nd August 2003 was mere 
coincidence. 
4.388  Moreover, if the European Communities has sci entific questions about biotechnology, those 
questions can be and should be addressed within  the context of the European Communities' own 
approval system, and in a manner cons istent with its WTO obligations.  Indeed, this is just how the 
European Communities approached sci entific and technical issues for the biotech products that the 
European Communities approved prior to October 1998. 
4.389  Similarly, the European Communities does not claim, and could not claim, that any 
proceedings in other international fora absolve the European Communities from complying with its 
WTO obligations regarding biotech products.  Mo st notably, the European  Communities discusses the 
Biosafety Protocol at length.  The European Communities itself, however , acknowledges that the 
Protocol explicitly provides that parties may not  disregard their existing international obligations in 
their implementation of the Biosafety Protocol.  Furthermore, the Biosafety Protocol foresees a 
functioning regulatory system in each Party count ry; it does not provide an excuse for refusing to 
make prompt, transparent decisions.  
4.390  The second general comment regarding the Europ ean Communities' submi ssion concerns its 
arguments on the a pplicability of the SPS Agreement .  In this discussion, the European Communities WT/DS291/R 
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  argues at length, and in the hypothetical, that th e European Communities might adopt measures that 
are not covered within the scope of the SPS Agreement .  But, once again, the European Communities 
does not link its discussion to the lega l issues in this dispute.  The pertinent question is whether the 
measures that the European Commun ities has actually adopted, and that are covered in this dispute's 
terms of reference, are within the scope of the SPS Agreement .  And, the European Communities' 
measures in this case are plainly included within the scope of the SPS Agreement .  
4.391  The third general comment is that the Europ ean Communities has attempted to de-emphasize 
the general moratorium.  The United States wishes to reemphasize, as made clear in its opening 
submission, that the general moratorium is at the co re of this dispute.  The United States brought this 
dispute because the European Communities at the hi ghest levels announced a general moratorium on 
biotech approvals, and followed through on those pronouncements by failing to approve any biotech 
products for over 5 years.   
2. General moratorium violates the SPS Agreement  
4.392  The European Communities' discussion of the gene ral moratorium is remarkable in that it is 
concerned solely with whether or not the gene ral moratorium qualifies as a "measure" under the 
SPS Agreement .  Should the Panel find, as the complaini ng parties all submit, that the general 
moratorium is indeed a measure under the SPS Agreement , the European Communities has not
 
contested that the general moratorium:  results in "u ndue delay" in breach of Article 8 and Annex C; is 
inconsistent with its obligations  under Article 7 and Annex B to  publish measures promptly; is 
inconsistent with its oblig ations under Article 8 and A nnex C(1)(B) to keep applicants informed of the 
progress of applications; is not based on a risk asse ssment as required under Article 5.1; and results in 
arbitrary or unjustifiable distinctions in the le vels of protection in breach of Article 5.5.  
4.393  The evidence that the general moratorium exists  is overwhelming.  To summarize the facts in 
the first written submission of the United States:  Up to October 1998, the European Communities had 
approved at least ten biotech products.  But be tween October 1998 and August 2003, the European 
Communities failed to approve a single biotech pro duct under its novel foods or deliberate release 
legislation, even though many of those produc ts had been favourably assessed by the European 
Communities' own scientific committees.   
4.394  The moratorium became widely known no later than June 1999, when it was announced by 
Environment Ministers of five member States.  In particular, at a Council Meeting of EC Environment 
Ministers in June 1999, Environment Ministers of Denmark, Greece, France, Italy and Luxembourg 
issued a Declaration stating: "in exercising the powers vested in them regarding the growing and 
placing on the market of genetically modified organisms … they will take steps to have any new 
authorizations for growing and placing on the market suspended ." 
4.395  The statements of Commission and member St ate officials confirm the existence of a 
moratorium.  For example, the European Commun ities' official representative to the SPS Committee 
acknowledged the existence of the moratorium.  At the meeting of the SPS Committee held on 
31 October-1 November 2001, the summary of the meeting notes the following European Communities' response:  "The recent meeting of the European Environmental Council had started a 
very important discussion on proposals presented by the Commission to restart  the authorization 
procedure."  The EC representative's statement that there were proposals to restart  biotech 
authorization procedures is plainly an acknowledgmen t that those procedures had been suspended.  
4.396  Commission documents also confirm the existen ce of the moratorium.  Most recently, in an 
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  2004, the following statement appears: "The adoption of a decision to authorize Bt-11 would bring an 
end to the current moratorium  on genetically modified food and feed in Europe." 
4.397  The European Communities first written submi ssion in fact goes quite a long way toward 
conceding the existence of the moratorium.  In  describing the reasons for adopting a modified 
directive, the European Communities' submission states:  These issues [meaning issues relating to 
alleged scientific uncertainty] affected some of the pending applications as a number of member 
States made it clear that they were not in a po sition to vote in favour of granting market 
authorizations  for individual products without these issues being addressed first."  This statement is 
quite close to a confirmation of the basic point that the complaining parties are making in this dispute: 
namely, that at a certain point in time, certain member States decided that they simply were not going to vote for new product approvals.  Under the Eur opean Communities' rules of qualified majority 
voting, a minority of member States can block European Communities' action.  Blocks by qualified majority in the regulatory committee may be overridden by a simple majority vote in the Commission.  
But, as the record here shows, the European Communities has decide d not to submit final decisions 
for a majority vote by the Commission.  In addition, if one of those "number of member States" that are unwilling to grant market authorizations were the original recipient of the application, then that 
single member State may block a Deliberate Release application all by itself.  
4.398  Turning to the European Communities' ar guments as to why there was no general 
moratorium, the European Communities first argues th at it cannot be "legally affected" by "casual 
statements of any of its numerous representatives" .  But the complaining parties are not relying on 
"casual statements of numerous representatives"; the statements cited by complaining parties are statements made by the European Communities' high est officials, by its member States, and by its 
official bodies.  Moreover, the European Communities itself concedes, as it must, that such statements 
can be considered as evidence of  the existence of a measure. 
4.399  The European Communities' second response is to  submit application histories for each of the 
products covered by the moratorium.  This informa tion, however, is entirely consistent with the 
European Communities' imposition of a general moratorium.  First, the information submitted by the 
European Communities confirms that there were in  fact no approvals of biotech products between 
October 1998 and the establishment of the Pa nel's terms of refere nce in August 2003. 
4.400  Second, we would like to point out a few a pplications in which even the European 
Communities' own exhibits show quite clearly how the moratorium operates.  The European 
Communities' submission writes that the two oilseed  rape products were a pproved for cultivation, 
import, and marketing under the 90/220 Directive at  "Community level."  However, the European 
Communities' submission entirely fails to note that  under Directive 90/220, the "Community level" 
approval is not
 effective unless and until the member State that initially received the application takes 
a final step of placing the product on the market.  In  this case, that member State, which was France, 
never allowed the product to be placed on the ma rket.  Thus, these products in fact were never  
approved for cultivation, import, and mark eting in the European Communities.   
4.401  We would also like to refer to the example of  Bt Cotton.  Spain, the member State that 
initially received the application, forwarded it with a positive opinion to the European Communities in 
November 1997.  The EC Scientific Committee on Plan ts made a favourable assessment in July 1998.  
However, in February 1999, the regulatory committe e did not approve the application by a qualified 
majority vote.  Under the European Communities' ow n rules, an application that fails to achieve a 
qualified majority of votes in the regulatory committee must  be submitted to the EC Council for an 
additional vote, and such submission must be made, to quote Article 21 of the EC Directive, "without 
delay."  But the European Communities' own chronol ogy states that the next action is nearly three WT/DS291/R 
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  months later, in May 1999.  And the action ta ken is not, as required under EC legislation, the 
submission of the application to the EC Council.  Instead, the chronology states:  "Launching of Inter-
Service Consultation on draft Council Decision."  To our knowledge, this term, and this step, are not 
provided for under the European Communities' regula tions.  The chronology is then blank until July 
of 2001.  We would submit that "Inter-Service Consulta tion" is just another word for the moratorium.   
4.402  Finally, we would like to address the applica tion under the Novel Foods regulation for Bt-11 
sweet corn.  This product received a favourable opi nion from the European Communities' Scientific 
Committee on Food over two years ago, in Apr il 2002.  The European Communities' submission 
states that the Commission was finally ready on 19 Ma y of this year to accept a proposal allowing the 
use of Bt-11 sweet corn for food use.  The Unite d States would like to make very clear that the 
measure that we are requesting that the Panel examin e is the measure in existence at the time when 
the Panel and its terms of referenc e were established, which is the me asure in effect as of 29 August 
2003.  Also, the United States would not view an approval of Bt-11 as a lifting of the European 
Communities' moratorium or as an indication that th e EU will begin to meet its WTO obligations by 
making decisions on all other pending applications without undue delay.  But any issues relating to 
whether or not steps taken by the European Communities after August 2003 have brought the European Communities into compliance with its WTO obligations are not before the Panel.  
4.403  We would also note that the Bt- 11 approval, should it occur, is en tirely consistent with, and in 
fact supports, the existence of the general mo ratorium.  As noted above, both the European 
Commission and the Council have stated that the en try into force of the European Communities' new 
traceability and labelling rules for biotech product s might finally allow for the lifting of the 
moratorium.  Those new rules went into effect on 19 April 2004.  The fact that the Commission then 
approved Bt-11 just one month later is, at least in our view, certainly no mere coincidence.  To the 
contrary, this timing indicates that, as the Eur opean Communities itself ha s acknowledged everywhere 
but in its First Written Submission, the European Communities' approval system was held up not by 
any problems with particular applications, but by ev ents outside the scope of its approval legislation.  
Moreover, the EC Council itself acknowledges the existe nce of the "moratorium" – it uses this very 
word – in a statement concerning the scheduled Bt-11 approval.  
4.404  As discussed in the first written Submission of the United States, the European Communities' 
approval regime, including that part of the regime  modified by the general moratorium, is plainly a 
"sanitary or phytosanitary" measure.  However, in  light of the European Communities' hypothetical 
discussion of the types of risks covered by its Delib erate Release legislation, the United States would 
like to make the following points.  The Europ ean Communities notes that its Deliberate Release 
directive repeatedly uses the word "environment".  The idea, however, that all environmental issues 
are outside the scope of the SPS Agreement  is plainly wrong.  Article 5.2 of the Agreement explicitly 
requires the consideration of relevant ecological and environmental conditions in an assessment of 
SPS risks.  In addition, the definition in the SPS Agreement  of an SPS measure includes "Any 
measure applied to protect animal or plant life or he alth within the territory of the Member from risks 
arising from the entry, establishment or spread of  pests."  The agreement explicitly provides that 
animal includes "wild fauna", and that "plant" in cludes "forests and wild flora."  Certainly, the 
protection of wild fauna, forests, and wild flor a are elements of environmental protection.  
4.405  The European Communities' last defence is to argue that even if the European Communities, 
as a matter of fact, adopted a general moratori um on approvals of biotech products, such a 
moratorium is legally precluded from qualifying as a "measure" under the 
SPS Agreement .  The 
European Communities' argument is based on two pane l reports that considered the status under the 
Anti-Dumping  and Subsidies Agreements  of investigating authorities' so-called "practices".  But, the 
conclusions in those reports are not applicable to the determination of whether an actual moratorium  WT/DS291/R 
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  on approvals (as opposed to a "practice") is a me asure.  Unlike the complaining parties in those 
disputes, the complaining parties here are not saying that a pattern of decisions itself constitutes  a 
measure.  Instead, the co-complaining parties have pointed to an unbroken pattern of decisions (or 
rather, to an unbroken pattern of l ack of decision) as the inevitable result  of the moratorium, which is 
itself an independent measure.  
3. Product-specific moratoria violate the SPS Agreement  
4.406  Turning to the European Communities' product-specific moratoria, whether one views them 
as separate measures or simply as undue delay in th e approval process of these individual products, 
the European Communities once ag ain asserts that no such measures ever existed and that no 
application faced any undue delays.  The primary ba sis for the European Communities' denial of the 
product-specific moratoria is the vague statement that "what has happened in many
 of these 
applications is that, at different stages of the pro cedure, requests for additional information have been 
put to applicants."  Nonetheless, contrary to th e European Communities' assertions, its own exhibits 
show that applications stalled in its approval system without justification.  
4.407  Earlier in this statement, we noted the examples of how Bt Cotton and two oilseed rape 
products had stalled in the approval process.  We w ould also like to point out the example of Roundup 
Ready Cotton.  Spain, the member State that initia lly received the application, forwarded it with a 
positive opinion to the European Communities in November 1997.  The European Communities' 
Scientific Committee on Plants made a favourable assess ment in July 1998.  In February 1999, the 
Roundup Ready cotton application, like Bt cotton, did not receive a qualified majority vote in the 
regulatory committee.  Like for Bt cotton, the next  step in the European Communities' chronology is 
the "Launching of Inter-Service Consultation on draf t Council Decision" in May 1999.  There is no 
further entry in the chronology until January 2003, whic h is more than 2½ years later.  Again, this is 
another example of a major delay that was not ca used, as the European Communities' claims, by a 
pending request to the applicant for additional information. 
4.408  These chronologies also highlight how the product-specific moratoria are inconsistent with 
the related procedural obligations in Annex C(1)(b) of the SPS Agreement .  In the Bt Cotton, 
Roundup Ready Cotton, and oilseed ra pe applications, the applicant is not informed in a precise and 
complete manner of all deficiencies, or of the resu lts of the approval procedure.  To the contrary, 
when the regulatory committee fails to approve an application by a qualified majority vote, or when 
the EC Commission enters into "Inter-Service Consulta tions" rather than sending an application on to 
the Council, the applicant is given no explanation, and thus no opportunity to correct any deficiencies.  The same is true when, as for the oilseed rape produc ts, the member State that originally received the 
application fails to take the final step of placing a product on the market. 
4. Member State measures violate the SPS Agreement  
4.409  Like the moratoria (general and product-sp ecific), the member State measures are SPS 
measures which affect international trade.  Each of the six member States have imposed bans on approved biotech products, but none of the member States put forth a "risk assessment" as defined in Annex A, paragraph 4.  These measures are thus  not "based on" "risk assessment[s]" as required by 
Article 5.1 of the SPS Agreement .  
4.410  In fact, the only risk assessments put forth fo r the banned products are the positive scientific 
assessments rendered by member States to which th e products were submitted, and then by the 
European Communities' own scientific committees.  In  the case of each me mber State ban, these 
favourable assessments were reaffirm ed when the scientific committees considered and rejected the WT/DS291/R 
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  information provided by the member States.  Thus, the member State measures do not bear a "rational 
relationship" to the European Communities' positive risks assessment, and are not "based on" a risk 
assessment, in violation of Article 5.1.  
4.411  The European Communities puts forth a number of  defences of the member State measures – 
each is without merit.  First, the European Comm unities makes the vague and cryptic argument that 
"It results from that analysis [of Sections II.A.4, III.B.3 and II.D.4 of its submission] that each of the 
member State measures was adopted for some reasons that fall within the scope of the 
SPS Agreement , and some reasons that do not fall within the SPS Agreement ."  The United States is 
not able to discern from this assertion what reasons  the European Communities is referring to that it 
considers outside the scope of the SPS Agreement .  But no matter.  The important point is that the 
European Communities does not dispute, and in fact agrees, that each
 of the member States measures 
was adopted for "some reasons" that  fall within the scope of the SPS Agreement .    
4.412  Second, the European Communiti es argues that each of the meas ures fall within the scope of 
Article 5.7 of the SPS Agreement .  But the European Communities does not specify how Article 5.7 
might apply.  Its only argument is that under the terms of the EC legislation, the member State 
measures are labeled as provisional.  The mere labe l of a measure, however, is most certainly not 
sufficient to bring it within the scope of Article 5.7. 
4.413  To the contrary, as the Appellate Body has found,  a measure must meet four requirements to 
fall within the scope of Article 5.7.  Each of the member State measures, however, fails to meet any of 
these four requirements.  First, the measures were  not imposed because scientific information is 
"insufficient."  To the contrary, the Europ ean Communities and its scientific committees found 
sufficient information to evaluate and render pos itive assessment for each of the banned products.  
Second, the measures were not based on "available pe rtinent information."   To the contrary, as the 
European Commission stated in a memo, the memb er State measures "have been examined by the 
Scientific Committee on Plants, which in all cases deemed that the information submitted by the 
Members States did not justify their bans."  Third,  there is no evidence that the member States have 
sought to "obtain additional information" concerni ng the banned products in order to make a "more 
objective assessment of the risk."  In this regard, we note that all the member State measures were 
adopted in the period 1997 to 2000, in other words mo re than four years ago.  Finally, by failing to 
seek and obtain additional information, the member St ates have also failed to review the measure in 
light of such information "within a reasonable period of time".  
4.414  Third, the European Communities argues that ev en if the member State measures fall outside 
the scope of Article 5.7, that the measures are noneth eless consistent with Article 5.1 because they are 
based on a risk assessment.  The European Communities' only support for this position, however, is 
the conclusory statement that the "member Stat es may have drawn their own conclusions from the 
relevant risk assessments."  The only "relevant risk  assessments" of which the United States is aware, 
however, are those by the EC scientific committees providing positive  assessments of the banned 
products.  The European Communities has failed to identify any other "relevan t risk assessments", nor 
to explain how the member State marketing or import bans could be based on such assessments.  In short, the European Communities' argument that the member State measures are consistent with 
Article 5.1 is without merit.   WT/DS291/R 
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  J. F
IRST ORAL STATEMENT OF CANADA  
1. Introduction 
4.415  Until October 1998, the European Communities had a functioning approvals process for 
agricultural products produced from modern biot echnology.  Since then, it has maintained a 
moratorium on the approval of new biotech products.  The moratorium has been maintained in the face of uncontroverted opinions of the European  Communities' own scientists that (i) there is 
sufficient evidence to reach conclusions about the sa fety of these products, and (ii) that there is no 
evidence to show that these products  pose a risk to human health or the environment.  In addition, 
several EC member States are maintaining national bans on biotech products that had been approved 
by the European Communities prior to the institution of the moratorium. 
4.416  The European Communities' principal defence is that the moratorium does not exist.  As for 
its member State national measures, the European Communities' principal defence is that Canada 
should have challenged these under Article 5.7 of the SPS Agreement .  None of these arguments have 
any merit. 
2. Issues relating to the moratorium  
4.417  In this section, Canada will demonstrate th e following three propositions:  the European 
Communities maintains a moratorium on the approva l of biotech products; the moratorium is a 
challengeable measure; and, the moratori um is a SPS measure for the purposes of the SPS Agreement . 
(a) The European Communities maintains a moratorium 
4.418  Since 1998, with one, very recent, exception,  the European Communities has failed to 
approve a single application for biotech products although there are over 30 applications in the 
approval pipeline.  Many of these applications ha ve received not one, but two, favourable risk 
assessments by the European Communities' own scientific bodies. 
(i) The moratorium is in effect 
4.419  The European Communities gives effect to the moratorium through concerted acts and 
omissions that stall applications at key decision- making stages in the approval process.  This converts 
the pre-marketing approval requirement into an  across-the-board marketing ban on new biotech 
products. 
4.420  The key stages at which the blockage occurs  are highlighted by the following acts and 
omissions: 
• EC member State competent authorities have  failed to ensure that the approval 
procedures are completed without undue delay;  
 
• Certain EC member States routinely object to favourable assessments by the 
competent authority of another member State;  
 
• Where an application is supported by fa vourable risk assessments, the Commission 
has failed in all but four cases to submit a draft measure approving a biotech 
application to the Regulatory Committee; 
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  • EC member States routinely block the adoption of a favourable opinion by the 
Regulatory Committee, regardless of the scientific merits of the application;  
 
• Where there has been an impasse at th e Regulatory Committee, the Commission has 
failed to refer the matter to the Council of Ministers; and finally, 
 
• When the Commission has approved a product, the responsible member State has 
failed to issue the consent letter necessar y to be able to market the product. 
 
(ii) The European Communities denies the ample evidence of the moratorium 
4.421  The European Communities denies that the morato rium exists.  It says that the lack of 
decisions is a coincidence, caused by a series of unrel ated delays in individual applications for biotech 
products arising from the insufficiency of scientific  evidence, the on-going changes in the European 
Communities' regulatory regime, and requests for inform ation.  This is at odds with the facts and the 
opinions of the European Communities' own scienti sts, and with how the European Communities' 
own officials and documents have characterized th e situation.  The Europ ean Communities also says 
that Canada cannot point to any law or other formal  act on the part of the European Communities that 
supports the existence of a moratorium. 
4.422  Canada has six points in response.  First , the June 1999 declaration undermines the 
"coincidence" argument.  Second , the Commission's own officials have described the situation as a 
moratorium; EC documents continue  to refer to a moratorium.  Third , although it is true that there is 
no law or other formal act that Canada can point  to, the European Communities cannot use its own 
lack of transparency as a sh ield in this dispute.  Fourth , the moratorium does not arise from the 
failure to approve a particular application; it is the general suspension of the approval process, 
resulting in the failure to consider for approval a ll applications.  The European Communities' attempt 
to treat delays in individual applications as is olated events ignores the surrounding circumstances.  
Fifth , the simplified procedure under Regulation 258/97  does not constitute an approval process; it 
does not require the Commission to take a decision, and other member States cannot block or stall this 
process.  Lastly , Canada does not argue that the moratori um involves a complete shutdown of the 
approval process; rather it is at the critical decisi on-making junctures, or key stages, of the approval 
process where applications have been blocked. 
(b) The moratorium is a "measure" 
4.423  Whether one calls the moratorium a "requirement",  "administrative guidance" or "practice" is 
immaterial.  It is still a measure.  A measure may be any act of a Member, whether or not legally 
binding, and it can include even non-binding admini strative guidance by a government.  In this case, 
the moratorium converts the pre-marketing approval re quirement of the legislation into an across-the-
board marketing ban on new biotech products just as effectively as an amendment to the approval 
legislation. 
4.424  The list of measures in Annex A is not exhaustive.   This is supported by the use of the word 
"include" in Paragraph 1.  There is no doubt that th e underlying approval legislation is a measure.  It 
is stands to reason that the moratorium, should also be interpreted as a measure.  To interpret 
"measure" narrowly would allow WTO Members to ci rcumvent their obligations by neglecting or 
refusing to adopt transparent, formal, legally bind ing laws, regulations or procedures; this would 
undermine the object and purpose of the SPS Agreement .  WT/DS291/R 
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  4.425  The European Communities uses two panel reports to argue that "a practice not laid down in 
any document whether formal or informal in char acter" is not a measure.  Neither case supports the 
European Communities' sweeping proposition. 
(c) The moratorium is an "SPS measure" 
4.426  The moratorium is not based on a legal instrument; therefore its purpose must be inferred 
from the context.  The 1999 declaration confirms th at the purpose of the moratorium is to protect 
human health and the environment from risks arisi ng from biotech products.  This suggests that the 
general suspension of the European Communities' approval procedures is based on concerns that 
those procedures could not adequately assess those risk s.  Thus, the purpose of the moratorium can be 
reasonably inferred from the underlying legislation. 
4.427  The European Communities has ad mitted that the purpose of its approval procedures is, at 
least in part, to protect against risks to human health and the environment that fall within the SPS Agreement .  It stands to reason that the purpose of  the moratorium is the same.  Thus, the 
moratorium was instituted, at least in part, to protect against risks identified in Annex A of the 
SPS Agreement;  therefore, it is an SPS measure.   
(d) The scope and application of the SPS Agreement  
4.428  Canada has five points to make with respect to the European Communities' arguments about 
the scope and application of the SPS Agreement .  First , the European Communities argues that the 
"SPS Agreement  was not intended to address the prevention of risks to the environment."  The 
European Communities highlights biodiversity, sugges ting that measures taken to protect biodiversity 
somehow fall outside of the scope of the SPS Agreement .  The European Communities concedes, 
however, that one of the risks posed by biotech products is that they may "choke or stunt" other 
plants.  In other words, biotech products may become  a pest or a weed.  This is both a concern for 
biodiversity and a risk identified under the SPS Agreement .  Thus, the suggestion that risks to 
biodiversity per se  are not covered by the SPS Agreement  should be rejected. 
4.429  Second , the European Communities asserts that the SPS Agreement  was not drafted with 
products like GMOs in mind.  The SPS Agreement  is not applied to products, per se , but to measures 
intended to protect against certain iden tified risks.  Moreover, when the WTO Agreement  was signed, 
Directive 90/220 had been in existence for several years and the European Communities had by then 
approved for commercial release several products. 
4.430  Third , the European Communities insinuates that measures regulating GMOs should be dealt 
"outside" the 
WTO Agreement  because GMOs have their own "special agreement", the Biosafety 
Protocol.  Again, this argument is  totally without merit.  To the contrary, the Biosafety Protocol has 
no material bearing on the issues in dispute before this Panel. 
4.431  Fourth , the European Communities states that th ere is "no precise match" between the 
European Communities' approval legisla tion and the objectives and scope of the SPS Agreement .  The 
implication of this is that a SPS measure, in this  case an approval procedure, is no longer subject to 
the obligations of the SPS Agreement  if it involves the consideration of non-SPS risks or other issues.  
The panel should reject this argument.  The obligations of the SPS Agreement  do not cease to apply to 
SPS measures merely because those measures are al so applied to protect against non-SPS risks. 
4.432  Lastly , the European Communities asserts that, with reference to Codex Standard 193, 
"toxin" as used in the SPS Agreement  should be limited only to naturally occurring toxicants that are WT/DS291/R 
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  not intentionally
 added to food.  Codex Standard 193 do es not purport to provide a comprehensive 
definition of "toxin".  It simply sets outs the types of  toxins included in the scope of that Standard.  
The limited definition of "toxin" in the Standard in no way limits the term as it is used in the 
SPS Agreement .  
3. The product-specific marketing bans 
4.433  The European Communiti es claims that the complaint is really about "undue delay", and 
denies there has been undue delay.  It attributes any delay to "requests for additional information".  However, the European Communities makes bald assertions unsupported by specifics and carefully 
avoids any discussion of the scientific op inions rendered by its own scientists. 
4.434  The European Communities fails to respond to Ca nada's claims under Articles 2.2, 2.3, 5.1, 
5.5 and 5.6 of the SPS Agreement . The European Communities bases this failure on the contention 
that "alleged behaviour cannot be an SPS measure itself as well as the application of another SPS 
measure." There is no basis in the SPS Agreement  for this contention.  In fact, there are many 
instances where an act can be both an SPS measu re and an application of another SPS measure. 
4. EC member State national measures 
4.435  In this section, Canada responds to arguments  made by the European Communities in its 
written submission, relating to the EC member State national measures . 
(a) Article 5.7 
4.436  The European Communities states that the "safeguard" measures are provisional measures, 
taken pending a full assessment at the Community le vel.  According to the European Communities, 
this "full assessment" will lead to either a ch ange in the Community-wide authorization or a 
termination of the national safeguard measures and that  "this will now be done in light of the changes 
in Community legislation".  It is not clear what this means. 
4.437  The European Communities argues that, because these measures are "provisional",  they must 
be assessed against Article 5.7, and that, because the complaining parties have not alleged violations 
of this provision in relation to these measures, they  have failed to demonstrate that the measures do 
not fall exclusively under Article 5.7; thus, th ere is no burden on the European Communities to 
respond to the complaining parties' claims that th e measures are inconsistent with the remaining SPS 
provisions.  This argument is without merit. 
4.438  The language in Article 5.7 does not exclude the applicability of all other SPS provisions 
simply on the basis that the measures in question are provisional.  The starting point for an analysis of 
an SPS measure is Article 2.  It establishes basic ri ghts and obligations of the Members with respect to 
their SPS measures.  Such measures must be based on scientific principles and must not be maintained 
without sufficient scientific evidence.  Whether the measures are provisional or not is beside the point. 
4.439  In any event, the provisional nature of a given measure does not exclude the remaining 
provisions of the SPS Agreement  from applying to it unless those other provisions indicate that they 
do not apply to provisional measures.  For example, Article 2.2 is not expressed in terms that limit its application to "permanent" measures.  A Member is free to challenge a provisional measure under 
Article 2.2 as being maintained w ithout sufficient scientific evidence.   The Member must demonstrate 
that the measure in question is not adequately su pported by scientific evid ence.  Nowhere does the  WT/DS291/R 
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  jurisprudence indicate that  the Member must also demonstrate that the measure does not fall within 
the scope of Article 5.7. 
4.440  At the same time, Article 2.2 recognizes that  there may be circumstances where measures 
have to be taken in the face of insufficient scientific evidence.  In such circum stances, it is open to the 
Member defending such a measure to invoke Article 5.7.  The panel in Japan – Apples  recognized 
this.  The key  language in Article 5.7 is not the word "provisional", but the words "[I]n cases where 
relevant scientific evidence is insufficient …".  It is not the provisional nature of the measure that 
matters; it is the insufficiency of  the scientific evidence.  Thus, it is not enough for the European 
Communities to claim that the measure is provisi onal in order to exempt it from scrutiny under 
Article 2.2. 
4.441  The European Communities claims that certain  statements by the Appellate Body in Japan – 
Apples support its argument with respect to the objective scope of application of Article 5.7, and the 
proper allocation of the burden of proof.  Howe ver, the statements to which the European 
Communities refers do not explicitly address this matter. 
4.442  Furthermore, the European Communities refers to  the application of provisional measures in 
the Anti-Dumping Agreement  and the Subsidies Agreement  as support for its interpretation of 
Article 5.7.  However, these provi sions do not concern themselves with  the allocation of the burden of 
proof, and are therefore irrelevant to the Eur opean Communities' argument concerning the proper 
scope to be given to Article 5.7.  In short, they  have no bearing whatsoever on the issues before this 
Panel. 
4.443  The European Communities appears to base its argum ents with respect to Article 5.7 solely in 
relation to what it terms the "threshold" argument.  It claims that it is for Canada to demonstrate 
inconsistency with Article 5.7, and that Canada h as failed to discharge this burden.  The European 
Communities is mistaken on this point.  There is no burden on Canada until the European 
Communities invokes Article 5.7 and makes out a prima facie  case for its application. 
4.444  Even if the European Communiti es were correct that the departure point for an analysis of 
these measures is Article 5.7, these measures do not meet  the requirements of that provision.  Even a 
cursory review of the measures and the factua l and scientific circumstances surrounding their 
adoption and maintenance reveals that they fail to sa tisfy even one of the four required elements under 
Article 5.7. 
4.445  Under the first element, based on the opinions adopt ed by the European Communities' own 
scientific experts, there is no indication that there wa s insufficient scientific evidence to allow them to 
come to unambiguous conclusions.  Equally im portantly, those conclusions were uniformly 
favourable as regards the safety of the products in question.  Under the second  element, a measure 
that bans the commercialization or marketing of a pr oduct that has repeatedly been found to be safe by 
the competent scientific authorities cannot be sa id to be based on the "available pertinent 
information".  The 
third  element becomes irrelevant as a criterion, given the sufficiency of the 
scientific evidence available from the European Communities' own sources.  In any event, the 
European Communities has failed to demonstrate that the member States sought to obtain any 
additional information to support their measures, even in the face of the opinions of the European Communities' scientific experts that the informati on initially provided did not alter the original 
favourable risk assessments.  Finally, under the fourth element, to Canada's knowledge, no review 
has taken place at all, let alone "within a reasonable period of time". WT/DS291/R 
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  4.446  Because the EC member State national measures  do not satisfy any of the four required 
elements, they cannot fall within the scope of Article 5.7.  
(b) Article 5.1 
4.447  The European Communities claims that even if Article 5.1 applies, the use of the words 
"appropriate to the circumstances" … gives the WTO Members "a certain degree of flexibility in 
meeting the requirements of Article 5.1".  Canada agr ees that, in principle, Article 5.1 offers "a certain 
flexibility", but it is not of the kind identifie d by the European Communities.  The European 
Communities claims that the "circumstances" in th e present case are that "rel evant scientific evidence 
was or is insufficient".  Canada has already responded to this argument. 
4.448  Article 5.1 sets out a clear standard.  A risk assessment must meet that standard and the 
measures must be "based on" that risk assessment.  If the scientific evidence is  insufficient, it is for 
the WTO Member concerned to make its case under Artic le 5.7.  In this case, the risk assessments of 
the competent authorities of the sponsoring EC member States, and the scientific opinions rendered by 
the relevant scientific committees conclude that these products are sa fe.  These risk assessments and 
scientific opinions do not indicate that the availa ble scientific evidence was insufficient to support 
those conclusions. 
4.449  The European Communities does present ar guments for why it considers that the EC member 
State national measures are consistent with Article 5.1.  While it states that the measures are based on 
risk assessments, it does not identify those risk assessme nts.  The only risk assessments that Canada is 
aware of are the European Communities' own ri sk assessments, which found no evidence that the 
products in question are unsafe.  These do not bear a rational relationship to a ban.  Even if Canada 
accepted the European Communities' contention th at the same risk assessment, as a matter of WTO 
law, might 'sufficiently warrant – that is to say, reasonably support' – more than one possible SPS measure, depending, inter alia , on the specific legislator", the European Communities does not make 
it clear to which legislators or to which circumstance s it is referring.  In any event, publicly available 
risk assessments, which uniformly concluded that th ere was no evidence of a risk to human health or 
the environment, cannot be said to "reasonabl y support" a complete ban on such products. 
(c) Article 5.6 
4.450  The European Communities' arguments with respect to Article 5.6 are difficult to follow.  It is 
true that Canada bases its arguments with respect to Article 5.6 on an assumption as to the European 
Communities' appropriate level of protection.  The European Communities' legislation seems to 
indicate that the level of protection sought by th e European Communities w ith respect to biotech 
products is a high level of protection, but not zero risk.  Canada asks the European Communities to 
state clearly whether its appropriate level of protecti on is the level of protection that is set out in the 
relevant EC legislation, or the level of pr otection – that is, zero risk – implied by the EC member State 
national measures .  In any event, the European Commun ities has not refuted Canada's arguments 
under Article 5.6 and it remains open to  the Panel to conclude that the EC member State national 
measures are inconsistent with that provision. 
(d) Article 5.5 
4.451  The European Communities makes a number of assertions and statements in its written 
submission, none of which refute the prima facie  case that Canada has made.  WT/DS291/R 
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  4.452  Canada agrees with the European Communities that there is no inconsistency in the absence 
of arbitrary or unjustifiable distinctions.  However,  the European Communities has failed to address, 
much less refute, the arbitrary or unjustifiable distin ctions that Canada has demonstrated exist with 
respect to the appropriate levels of protecti on applied by the European Communities to the 
comparable situations outlined in Canada's written submission. 
4.453  When the European Communities' own experts una mbiguously find that there is no evidence 
to show that these products are unsafe, and the me mber States nevertheless ban the products and 
maintain those bans in the face of further scientif ic advice that such bans are groundless, this cannot 
be characterized as anything other th an a complete disregard or determination to ignore such opinions 
and advice.  When this is done on a selective b asis that bears no relationship to the actual risks 
involved, the conclusion is inescapable that the resulting measures give rise to a violation of Article 5.5. 
K. F
IRST ORAL STATEMENT OF ARGENTINA  
1. Introduction 
4.454  This case concerns inconsistencies with WTO obligations, arising from:  (i) the de facto  
moratorium which the European Communities has maintained from 1998 to the present;  (ii) the 
"suspension of processing and failure  to consider individual applications for specific products of 
particular interest to Argentina";  (iii) the "undue  delay";  and (iv) the bans imposed by some EC 
member States to the detriment of specific biotech agricultural products of particular interest to 
Argentina.  Argentina maintains th at the foregoing measures infringe the SPS Agreement . 
4.455  Article 3.2 of the DSU does not authorize any broad reliance on rules of public international 
law beyond the Covered Agreements  which would modify the rights and obligations of Members. 
Specifically, Argentina is of the view that it woul d not be proper for the Pa nel to look for additional 
endorsement from other rules of international law, such as the Cartagena Protocol, in interpreting the 
scope of the obligations included within the Covered Agreements . 
2. The de facto  moratorium is not based on scienti fic evidence and therefore infringes the 
SPS Agreement  
(a) The measure at issue in these proceedings 
4.456  The "de-facto" moratorium violates the SPS Agreement .  Argentina disagrees with the 
assertion of the European Communities that the compla ining parties have chosen to turn to the WTO 
dispute settlement procedures rather than to promote international cooperation.   
4.457  Argentina claims that the de facto  moratorium constitutes per se  a breach of WTO 
obligations.  This claim is separate from the clai m concerning the "suspension of consideration and 
failure to process specific applications for products of  particular interest to Argentina", and from  the 
claim regarding "undue delay".   
4.458  The European Communities has expressl y acknowledged the existence of a de facto  
moratorium, as indicated in the abundant documentary evidence supporting this affirmation.  Furthermore, the European Co mmunities has not responded to the evidence that Argentina has 
produced to show the existence of the moratorium.  WT/DS291/R 
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  4.459  The European Communities does not faithfu lly report the actual duration of the de facto  
moratorium, but attempts to reduce it to the peri od from 1998 to 2001.  This contradicts the European 
Communities' own statements which confirm what Ar gentina indicated in its submission (1998 to the 
present), on the basis of the need for further legislative changes. 
4.460  The European Communities starts from the premis e that the complaining parties have been 
"unable to identify an instrument or other text" by which the moratorium was established, and that the 
complaining parties' claims "are all in reality  complaints about delay".  This is because the 
complaining parties are addressing "omissions", whic h, in the European Communities' opinion, would 
not be challengeable under the WTO.  We note that  an "omission" is actionable under WTO rules.  
The European Communities' intent in so arguing is to divert the Panel's attention to what it calls issues 
"of procedure".  The European Communities is thus attempting to evade the substantive issues:  the 
de facto  moratorium and the lack of scientific evidence supporting the restriction.  
4.461  One of the elements that demons trate both the existence of the de facto  moratorium and the 
period during which it has been applied comprises st atements by EC officials having competence in 
the matter at issue.  Argentina nevertheless wishes to point out that the statements do not constitute 
the moratorium itself or the instrument embodying it, but are provided as facts demonstrating the existence of a de facto  moratorium. 
4.462  With regard to the European Communities' argument that the de facto  moratorium could not 
be identified in any instrument, Argentina in its submission specifically explains the specific 
characteristics of the de facto  moratorium measure.  Furthermore, the fact remains that no biotech 
agricultural products have been approved since 1998.   The European Communities concedes that it 
applied a moratorium on the approval of new pr oducts at least until its legislative process was 
completed. 
4.463  Argentina notes that the European  Communities has not based the de facto  moratorium on 
any scientific evidence.  On the contrary, the existing scientific evidence supports the position 
contrary to the de facto  moratorium, since it recommends approval of the biotech agricultural products 
at issue. 
4.464  Within the broader framework of the de facto  moratorium, a persistent  pattern of conduct by 
the European Communities can be observed.  Th rough actions and, essentially, through omissions, a 
de facto  moratorium has taken shape that is visible in the various stages of the procedures under EC 
regulations:  (i) Undue delay in completing the proc edures;  (ii) lack of action by the Commission in 
presenting the draft measure to the Regulatory Committ ee for approval of products that have received 
a favourable opinion from the  scientific committees ;  (iii)systematic opposition by member States to 
approval when a draft is submitted, with no scien tific grounds for opposing the Commission's draft;  
and (iv) failure by the European Communities to re fer a proposal to the Council of Ministers when the 
Regulatory Committee issues no opinion.  Although in the foregoing combination of actions and 
omissions within the European Communities' regula tory system some movement of applications 
through the various regulatory stages is visible, in the opinion of Argentina the movement is circular 
in nature and never results in approval. 
4.465  Argentina requests the Panel, on the basis of th e evidence submitted, to consider the existence 
of the de facto  moratorium as having been demonstrated above.   WT/DS291/R 
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  (b) Application of SPS Agreement  to the de facto  moratorium 
4.466  We will now address the purpose of the de facto  moratorium.  The purpose of the European 
Communities' regulations for the a pproval of biotech products is to determine , by means of case-by-
case assessment, the pres ence or absence of "additives", "contaminants" or "toxins" in foods, 
beverages or feedstuffs and the risks to human life and health resulting from their presence. Such 
regulations constitute a sanitary and phytosan itary measure within the meaning of the SPS Agreement . 
4.467  The risk arising from the mass consumption of varieties containing marker genes falls within 
the definition given in paragraph 1(b) of Annex A of the SPS Agreement . The risk arising from the 
cross-contamination of biotech products with othe r, undesired organisms falls within the scope of 
paragraph 1(d) of Annex A of the SPS Agreement  and of paragraph 1(c). Paragraph 1 of Annex A 
defines "pests", which include "weeds". 
(c) Conclusions with respect to the de facto  moratorium 
4.468  To sum up, Argentina considers that the Eur opean Communities is in obvious breach of the 
rules of the SPS Agreement .  Furthermore, the European Communities has itself admitted the 
existence of the de facto  moratorium, even when its own scientific committees have ruled in favour of 
the approval of various biotech agricultural products .  For this reason, Argentina respectfully requests 
the Panel first to find the de facto  moratorium inconsistent with Artic le 5.1, and then with Article 2.2 
of the SPS Agreement . 
4.469  Argentina notes that, should the Panel find in resp ect of this claim that  there is breach of 
Articles 5.1 and 2.2 of the SPS Agreement , it need not rule as to the inconsistency of the de facto  
moratorium with the other Articles of the SPS Agreement  cited, without prejudice to Argentina's 
reaffirming, in the light of the Panel's finding, the other arguments concerning the Articles of the 
SPS Agreement violated by the European Co mmunities that it adduced in its first written submission. 
3. The "suspension and failure to consider" is not based on scientific evidence and 
therefore violates WTO obligations  
4.470  Article 1.5 of the TBT Agreement  indicates that its provisions are not applicable to the 
sanitary and phytosanitary measure s defined in Annex A of the 
SPS Agreement .  Article 1.4 of the 
SPS Agreement  reaffirms the rights of the Members under the TBT Agreement  in respect of those 
measures not within the scope  of the SPS Agreement .  Therefore, a measure may be examined – under 
one or other of the two Agreements – only when both are in play.  The contrary would be a departure 
from the textual basis, which treats them as mutually exclusive. 
4.471  Argentina considers that, in this case, the object  of life and health protection places the 
measure within the scope of the SPS Agreement , regardless of the form  the measure takes.  This also 
rules out the applicability of TBT Agreement  which requires the existence of at least one document 
embodying a "technical regulation" or setting forth a procedure for conformity assessment.  The 
"suspension of processing and failure to consider" are not set forth in a document.  This in itself rules 
out application of the TBT Agreement  as a Covered Agreement against which the measures at issue 
are assessed for consistency. 
4.472  As to the biotech agricultural products consider ed individually, Argentina notes, for example, 
that the "suspension of processing" affected four of them, which had reached the stage of receiving 
favourable scientific opinions. WT/DS291/R 
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  4.473  With regard to Cotton Bt-531, the applicati on was filed in 1996 under Directive 90/220. It 
obtained a favourable opinion from the competent bo dy's biosafety committee in 1997.  In 1998, the 
Scientific Committee on Plants issued a positive opinion .  In 1999, the Regulatory Committee failed 
to obtain a qualified majority and so did not issue an opinion.  According to Directive 90/220, the 
Commission should have referred a pr oposal to the Council without delay
.  The Commission never 
made such a referral.  The application w as suspended until it had to be refiled under 
Directive 2001/18.  Although the product has had a favourable scientific opinion since 1998, as at 
June 2004 its marketing has not been authorized. 
4.474  With regard to Cotton RRC-1445, the applica tion was filed in 1997 under Directive 90/220.  
In 1998 the Scientific Committee on Plants issued a positive opinion.  In 1999, the Regulatory 
Committee failed to obtain a qualified majority and so did not issue an opinion.  According to 
Directive 90/220, the Commission should have refe rred a proposal to the Council without delay .  The 
Commission never made such a referral.  The appl ication was suspended unt il it had to be refiled 
under Directive 2001/18.  Although the product has had a favourable scientific opinion since 1998, as 
at June 2004, its marketing has not been authorized. 
4.475  With regard to Maize NK-603, the application was filed under Directive 90/220 in 2000 and 
was refiled under Directive 2001/18 in 2003.  The new European Food Safety Authority (EFSA) 
issued a favourable opinion.  The European Communiti es indicates that the requi site majority was not 
obtained in the Regulatory Committee and conseque ntly, the Commission sent a draft proposal to the 
Council.  Argentina trusts that after the favourab le scientific opinion Maize NK-603 will be approved 
this June as indicated by the European Commun ities.  Unfortunately, notwithstanding the favourable 
opinion of the EFSA, processing the same product under Regulation 258/97 offers  no alternative since 
there are no plans in the Council to address the application in question. 
4.476  With regard to Maize GA-21, the applicati on under Directive 90/220 dates back to 1998 and 
obtained a favourable opinion from the Scientific Committee in 2000.  In 2003 the application for 
approval of this product was wit hdrawn.  Argentina mentions this because the product is one of 
interest which, for nearly three years did not ob tain authorization despite favourable scientific 
evidence.  Under Regulation 258/97 the applica tion was filed in 1998 and obtained a favourable 
opinion in 2002 .  Despite the favourable opinion, no authorization has been obtained, placing this 
product in the category of those which, despite sci entific analysis, never obtained authorization. 
4.477  The European Communities has not refuted th e scientific evidence of its own committees, 
which recommended the approval of the products in qu estion, clearly depriving  of scientific backing 
the measures affecting the approval procedures of at least four of these products.  Therefore, 
Argentina's first claim is to a finding of inconsis tency of the "suspension of  processing and failure to 
consider" with the SPS Agreement , specifically with Article 5.1.  This would automatically imply 
inconsistency with Article 2.2 of the SPS Agreement . 
4.478  Furthermore, should the "suspension of processi ng and failure to consider" be found to be 
inconsistent with Articles 5.1 and 2.2 of the SPS Agreement , Argentina considers that the Panel need 
not address the inconsistency of the other legal prov isions cited in respect of these measures, without 
prejudice to Argentina's reaffirming, in the light of  the Panel's assessment, th e other arguments related 
to provisions violated by the European Communiti es that it adduced in its first written submission. 
4. The "undue delay" 
4.479  In Argentina's view, "undue delay" implies a violation of the provisions of Article 8 and 
Annex C of the SPS Agreement .  WT/DS291/R 
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  4.480  Both Directive 2001/18 and Regulation 258/97 set time limits for each stage in the control, 
assessment and approval of new biotech agricultura l products.  It is possible to estimate an 
approximate average length of time within which th e procedures can reasonably be completed.  The 
procedures established in EC regulations  should not, on average, exceed 240 days. 
4.481  The European Communities has simply failed to explain why new biotech agricultural 
products receive less favourable treatment under the same regulatory system – i.e. Regulation 258/97- 
than new "non-biotech" products.  For new biotech  agricultural products, the same procedures are 
applied in a way that results in an "undue dela y", while new "non-biotech" products subject to the 
same regulations are not delayed at all and have been approved. 
5. The state bans are not based on scien tific evidence and therefore violate the 
SPS Agreement 
4.482  First, with regard to the European Commun ities' argument concerning Article 5.7 of the 
SPS Agreement , Argentina reserves the right to develop this  point at a later stage of the proceedings. 
4.483  With regard to the measures applied by Germany, Austria, Italy and Luxembourg against 
certain biotech agricultural products, all of the affected products had the prior approval of the 
European Communities, based on scientific opinion s issued by the Euro pean Communities' own 
committees. 
4.484  Furthermore, some of these countries have resort ed to safeguard procedures in an attempt to 
justify their measures. This has resulted in new scientific opinions from EC committees, which have 
specifically refuted the grounds for the EC member State measures. 
4.485  Consequently, our first claim is again to a fi nding of inconsistency with Article 5.1 of the 
SPS Agreement .  Furthermore, that violation implies inconsistency with Article 2.2 of the 
SPS Agreement , according to WTO jurisprudence. 
4.486  Notwithstanding the foregoing, in the interests of procedural economy a finding of 
inconsistency of the state bans with Articles 5.1 a nd 2.2 of the SPS will obviate the need for a further 
finding that the bans by some EC member States vi olate the other legal provisions cited, without 
prejudice to Argentina's reaffirming, in the light  of the Panel's assessment, the other arguments 
concerning provisions violated by the European Communities that it adduced in its first written 
submission. 
6. Article XX of the GATT 1994  
4.487  Nowhere in their submissions have the complain ing parties indicated the possibility that the 
European Communities' conduct and breaches were ju stified under Article XX of the GATT 1994.  In 
this regard, the European Comm unities has the burden of proof, which cannot be deemed to be 
discharged by a mere assertion.  The European Communities has not put forward a single argument justifying the first test needed to invoke a provi sional exception under one of  the subparagraphs of 
Article XX of the GATT 1994, nor has it made any case whatsoever regarding the "chapeau".  
Argentina requests that the Panel reject this atte mpt by the European Communities to mount a defence 
based on an exception under Article XX of the GATT 1994. WT/DS291/R 
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  7. Special and differential treatment 
(a) In the framework of the SPS Agreement  
4.488  Argentina does not agree with the European Communities as to the scope and interpretation 
of the special and differential treat ment for developing countries as set forth in Article 10.1 of the 
SPS Agreement . 
4.489  In the opinion of Argentina, the European Communities has failed to respond and to 
demonstrate that it took into account and engage d in positive actions of the kind envisaged in 
Article 10.1 of the SPS Agreement , in deciding on and applying the de facto  moratorium to, 
suspending consideration of, not approving or undul y delaying approval of the biotech products of 
particular interest to Argentina.  The ban on all access for biotech agricultural products of particular 
interest to Argentina arising fro m the European Communities' fail ure to consider, suspension, non-
approval or undue delay in the approval of those pro ducts has, as argued, affected and continues to 
affect Argentina. 
4.490  In this regard, the European Communities is wrong in asserting that the claim is 
consequential.  To cons true Article 10.1 of the SPS Agreement  as containing only a consequential 
obligation is to devoid the provision on special  and differential treatment of substance. 
(b) In the framework of the TBT Agreement  
4.491  Argentina has already made its alternative claims regarding the TBT Agreement  in its first 
written submission, and will not bring them up he re other than to make the following comments 
relating to Article 12 of the TBT Agreement .  
4.492  The European Communities has li mited its response to the argument that Argentina infers 
violation of Article 12.3 in the event of a finding of  breach of Article 5.2.1;  and since the European 
Communities does not accept the existence of any violation, it concludes that there is no violation of 
this obligation. Argentina points out that the ar guments concerning the obligations laid down in 
Article 12.3 are much more extensive and are based on a detailed analysis of the logic of Article 12 as a whole.  
4.493  Argentina also emphasi zes that the European Communities has ignored the special trade, 
financial and development needs of developing countries.  The European Communities has not 
responded to this argument. 
4.494  Furthermore, Argentina puts forward argumen ts about the absolute ban on imports, whose 
main effect of the ban has been to prevent the access of biotech agricultural products of particular 
interest to Argentina not approved prior to 1998. The European Communities has failed to take into 
account the special needs of a developing countr y, in this case Argentina.  The European 
Communities has not responded to this argument. 
4.495  The European Communities submits that impor ts of biotech agricultural products from 
developing countries have not dec lined and, on the contrary, have increased since 1995/96 in the case 
of Argentina and Brazil. 
4.496  Argentina considers it necessary to clarify certain aspects of this claim. First, Argentina has 
made no reference to any increase or decrease in imports.  The GATT/WTO system protects not 
volumes of trade but competitive expectations.  Se condly, while the European Communities' claim  WT/DS291/R 
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  mentions in particular  "commodities likely to cont ain GMOs", what Argentina is referring to is an 
absolute ban on imports in respect to biotech agricu ltural products of particular interest to Argentina 
which have not been considered, or approved and ha ve been subjected to suspension or undue delays 
since 1998. Thirdly, Argentina disagrees with the European Communities as to the period during 
which the increase has occurred "since 1995/1996" in the European Communities' submission.  
Argentina argued that the absolute ban on impor ts into the European Communities of biotech 
agricultural products of particular intere st to Argentina started in 1998.   
(c) Conclusions regarding special and differe ntial treatment for developing countries 
4.497  Argentina is of the view that, through the arguments in its first written submission the 
European Communities has not refuted Argentina's argument in that it has not addressed the special 
needs of developing countries, in this case, Argentina, by according the mandatory treatment 
envisaged in Article 10.1 of the SPS Agreement .  Furthermore, the European Communities has not 
argued that in applying EC legislation to biotech agricultural products of particular interest to 
Argentina, it has observed the special needs of Ar gentina as a developing country, as the relevant 
provisions of Article 12 of the TBT Agreement  require.  Lastly, Argentina wishes to note that the 
special and differential treatment obligations set fo rth in the Agreements are not supplementary or 
lesser obligations. 
8. Conclusion 
4.498  Argentina reiterates the claims of inconsistenc y it put forward in its first written submission, 
and requests that they be analysed with a view to  procedural economy as proposed earlier in this Oral 
Statement, so that a prompt settlement of this  dispute can be reached  in accordance with the 
provisions of the DSU. 
L. F
IRST ORAL STATEMENT OF THE EUROPEAN COMMUNITIES  
1. Introduction 
4.499  The European Communities would like to express it s thanks to all three panellists for having 
accepted to serve on this Panel and to assist in the resolution of this difficult dispute.  The complex 
and controversial issues before the Panel are not only about science and societal values – they also 
raise some very difficult issues of legal interpretation. 
4.500  Despite the complaining parties' occasional attemp ts to suggest the contrary, this dispute is 
not about protectionism, nor is it about discrimination.  This is, in the view of the European Communities, a case about regulators' choices of the appropriate level of protection of public health 
and the environment in the face of scientific complex ity and uncertainty and in respect of which there 
is great public interest.  It is a case essentially a bout time.  The time allowed to a prudent government 
to set up and apply a process for effective risk asse ssment of products which are novel for its territory 
and ecosystems, and that have the potential of cau sing irreversible harm to public health and the 
environment.  In these matters there cannot be a " one size fits all" kind of solution and the Panel 
should resist the temptation to use simplistic appro aches, as suggested by the complaining parties.   
2. GMOs are still in their infancy 
4.501  For more than a decade, the world has witnes sed extraordinary advances in the field of 
genetic modification.  We have found ourselves are at a crossroads with many paths open in front of WT/DS291/R 
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  us, as new opportunities are created by tremendous technological advances while, at the same time, 
the need is felt to harness technological progress in a context of still limited scientific knowledge. 
4.502  Over that period, the international Community  has been busy considering what may be the 
appropriate roads to take to exploit the full potential of new biotechnologies while minimising any 
risks to human health and the environment.  The international Community has agreed that special 
rules are needed to address GMOs, since GMOs are i nherently of a character which requires particular 
scrutiny, and that, in the face of scientific uncertain ty, states' actions should be based on precaution.  
That conclusion is notably enshrined in the Conve ntion on Biological Diversity and the Cartagena 
Protocol on Biosafety.   
3. GMOs are characterised by scientific complexity 
4.503  As early as the end of the 1970s, the need w as identified to address the potential risks of 
genetically modified organisms for human health and the environment differently compared to non-
GM organisms, because of the extraordinary ne w potential of genetic engineering.  The new 
technology has brought to us the ability to theoreti cally introduce within any living organism, as 
quickly as it takes to go from one generation to the next, any trait from any other organism, and more importantly, totally new properties to that organism, as yet inexistent in nature. 
4.504  The science necessary to assess the risks of th ese new combinations, and in particular any 
long term, indirect, or delayed effects, has had a nd is having a hard time to catch up with the rapid 
development of new GM products.  The science trad itionally used in risk assessment can hardly 
apprehend all the properties of highly complex i ndividual organisms, the interaction between 
organisms, and the full picture of the ecosystems or  the agroecosystems that might be affected, taking 
also into account that the consequences of the in troduction of GMOs into the open environment can 
be highly variable between different ecosystems. 
4.505  Furthermore, GMOs are living organisms, and they are able to reproduce autonomously.  Any 
measure bringing a GMO into the environment has th erefore a character of irreversibility.  Another 
element to be considered is that the experience we  have today of GMOs is still very limited both in 
time and in quality, as the acquisition of this  technology has happened at a pace which is 
unprecedented in the history of agriculture.  However, only an extremely limited number of inserted genes are widely used in agriculture and very fe w systematic studies exist or have been planned on 
this limited set of GMOs.  As a consequence,  many questions remain as yet unanswered. 
4.506  The debate on the uses of modern biotechnolog y and its potential impact on public health, 
sustainability and biodiversity should be seen agains t this growing awareness of the fragility of human 
conditions and natural systems.  On all of this, the complaining parties are silent.   
4. GMOs raise the need for targeted regulatory approaches 
4.507  In the face of the fast evolution of science, the European Communities, as well as many other 
governments, have chosen to act prudently, settin g up effective processes for risk assessment to be 
performed before any of these new products is accepted for production, importation or 
commercialisation.  In a context of growing awar eness over possible effects of agriculture on health 
and the environment, countries that had developed early-on a regulatory framework for GMOs had to 
revise it in recent years and to adapt it to take account of new scientific and economic issues.  Both Canada and the United Sates are examples of countri es which are in the process of developing more 
stringent regulatory frameworks.  WT/DS291/R 
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  4.508  Scientific evolution is not, however, the only fact or to take into account.  As the joint EU/US 
Biotechnology Consultative Forum concluded in December 2000,  
"judgements about risk cannot be reduced to  scientific assessment alone.  There are 
legitimate concerns for which science, at least natural science, cannot provide 
answers.  Such concerns may cover issues of distribution of power and influence, risks of concentration of knowledge and expe rtise to a few very large corporations, 
relations between different social groups  and classes, between ethics and social 
values, between large corporations and small companies, between small-scale 
subsistence farmers and family farmers and the agroindustrial complex, between 
developed and developi ng countries.  As is true of al l technologies with the potential 
for far-reaching benefits, the societal consequences are far reaching as well". 
4.509  The move towards a strong regulatory process has not been limited to the national dimension.  
The international Community has been working thr ough the last two decades in order to develop a 
proper framework to address the specificities of GMOs , and by now, international consensus exists on 
a number of issues related to GMOs, such as the ne ed for a tailor-made regulatory regime for GMOs, 
including pre-marketing authorization; the right of each country to make its own decisions on each and every GMO on the basis of its legitimate policy goals; the right to adopt a precautionary approach 
when dealing with GMOs; the need for labelling and post-marketing surveillance. 
5. The regulatory choices of the European Communities are those of a prudent, 
responsible government 
4.510  Against this background, the European Commun ities believes that its ac tions have been and 
are those of a prudent government.  Over the year s, far from having "stalled the process", as is being 
alleged, the European Communiti es has worked diligently to desi gn and put in place a regulatory 
environment for GMOs which takes into account hea lth and environmental concerns while allowing 
their production, importation and marketing. 
4.511  In parallel, and as demonstrated by the forty-nine detailed chronologies that the European 
Communities has submitted in its first written subm ission, the European Communities has continued 
the assessment of each individual application on a case-by-case basis, anticipating, to the extent 
possible, the application of the standards of review of the upcoming legislation to pending 
applications.  This has always been done in a c onstant and continued dial ogue between the various 
levels of the EC administration and the applicants. 
6. The case of Bt 11 Maize 
4.512  Bt 11 Maize – the product that was granted a market authorization two weeks ago – is a 
perfect illustration of the fact that the approval process, far from being stalled, has been steadily 
proceeding over the past years.   
4.513  Bt11 maize was notified in 2000 and moved up to the Community level quite quickly.  The 
European Commission asked its scientific committe e for advice on this dossier in December 2002 
and, as soon as the applicant provided the necessary data (this took him more than two years), the 
Committee issued its opinion.  In line with the new legislation that was being prepared, the applicant, 
on a voluntary basis, agreed to provide the necessary materials to develop validation and detection 
methods, but it took more than a year to obtain the necessary material fro m the applicant.  The 
detection and validation method was then rapidly finalized and the decision-making process launched 
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  exactly as provided for in the legislation and, thus, the decision was adopted by the Commission two 
weeks ago. 
4.514  This marketing authorization has not happened overnight because of a sudden change in the 
European Communities' policy on GMOs.  It is simp ly the result of a normal process of assessment.  
How else can you prove the absence of a moratorium if not through demonstrating that the approval process moves on and results in decisions? 
7. Legal issues 
(a) Preliminary legal remarks 
4.515  First, the European Communities is  struck by the fact that all the complaining parties, who 
have the burden of proof, are requesting the Panel NOT to have recourse to scientific and technical 
advice.  It is interesting to note that it is only the defendant who is open to a clarification of the facts 
in this case on the basis of expert advice.  It is de finitely not the case that there are no scientific facts 
in dispute.  For instance, the European Communitie s does contest that the risks involved in GMOs are 
no different from those presented by conventional products.  Most importantly, the views of the 
European Communities' scientific committees, now regrouped under the European Food Safety 
Authority, have no formal overriding effect on the opinions of the corresponding national committees, 
and they are only part of the evidence that EC authorities may use as a risk  assessment within the 
meaning of the SPS Agreement .   
4.516  Second, as explained in the European Communitie s' first written submission, it is simply not 
tenable to examine the facts of this dispute in the light of the SPS Agreement only.  The complaining 
parties' approach is too simplistic.   
4.517  In fact, both these features of the way in wh ich the complaining parties are conducting their 
case are illustrative of one fact.  That the complaining parties want to avoid that the Panel enters into 
any detailed factual or legal analysis of the Eur opean Communities' actions, which they intentionally 
misrepresent.  They want this Panel to rule on certain issues of general concern for all WTO 
Members, but in a biased way and in the light of only limited information.  It is the defendant that is 
prepared to confront these complexities fairly and sq uarely and seek to resolve them, in order to show 
the true simplicity of the case: there is no moratorium  and no suspension to rule on.  There is only a 
series of prudent actions in response to concerns shared by responsible governments around the world.   
(b) The correct approach to interpretation 
4.518  A correct interpretation of the balance of rights and obligations contained in the WTO 
agreements has to ensure a close and careful read ing of the text of the individual agreement in 
question, and a reading of the relevant WTO provi sions in accordance with other international law 
instruments and the Appellate Body's findings on the need to take into account the "contemporary 
concerns of the community of nations about th e protection and conservation of the environment
80".  
Thus, the provisions at stake in this case will have to  be interpreted not in c linical isolation from, but 
rather in the light of, the other existing instruments of international law referred to in the European 
Communities' first written submission. 
                                                      
80 Appellate Body Report, US – Shrimp , para. 129.  WT/DS291/R 
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  (c) The SPS Agreement  alone cannot dispose of all the issues linked to GMOs 
4.519  The scope of the SPS Agreement  is identified in the text of Annex A, point 1, as relating 
exclusively to measures to protect animal or plant life or health within the territory of the Member 
from precise risks such as "the entry, establishm ent or spread of pests, diseases, disease-carrying 
organisms or disease-causing organisms"; "additives,  contaminants, toxins or disease-causing 
organisms in foods, beverages or feedstuffs"; or "diseases carried by animals, plants or products 
thereof, or from the entry, establishment or spread of pests".  The text of this provision was carefully 
negotiated, is very clearly phrased and has to be st rictly interpreted and applied.  In particular, 
contrary to the complaining parties' approach, it cannot be read as applying to all products and all 
risks in all circumstances.  Follo wing such an approach amounts to reducing the whole of point 1 of 
Annex A to inutility. 
4.520  The Panel will thus have to assess under the SPS Agreement  only those measures adopted for 
reasons that fall within the scope of that Agreem ent.  A same measure can  pursue multiple objectives 
which fall within the scope of different WTO agreemen ts.  This possibility is not only inherent in the 
text of the agreements but it is also recognized, as noted above, by the current practice of other Members of the WTO, as is evident from the no tifications of draft measures to the SPS and TBT 
Committees.   
(d) The issue of delay  
4.521  The European Communities does not contest that  the WTO agreements apply to delays, or 
more generally to omissions or failures to act, and it has shown its readiness to answer to the Panel for 
each and every instance of such alleged delays und er the WTO agreements.  However, it is obvious 
that only WTO provisions that address such failures to  act within a given timeframe can be relevant.  
The SPS Agreement  contains such obligations in its Article 8 and Annex C.  Other provisions listed by 
the complaining parties do not address delays but the very opposite, namely actions or acts.  They 
address the development and content of SPS measures, not their application.   
(e) Article 5.7 SPS Agreement   
4.522  The European Communities considers that to th e extent that the national safeguard measures 
come under the SPS Agreement  they are regulated by Article 5.7 of the SPS Agreement .  and not by 
the other provisions of the agreement invoked by the complaining parties.  The burden of proving that 
the conditions of Article 5.7 are met is on the comp laining parties, as the United States has formally 
acknowledged at the meeting of the DSB held  on 10 December 2003.  Thus, the European 
Communities sees the relationship between Article 5.7 and the rest of the agreement in the same way 
as the Appellate Body saw the relationship between Articles 3.3 and 3.1 of the SPS Agreement  – as an 
autonomous right.
81   
(f) The precautionary principle is a general principle of international law  
4.523  Article 5.7 of the SPS Agreement  is of course one expression of the precautionary principle – 
Article 3.3 is another.  This principle has by now  become a fully-fledged and general principle of 
international law.  This is another reason why Artic le 5.7 is an autonomous right, an autonomous right 
that is also recognized in the Biosafety Protocol.   
                                                      
81 Appellate Body Report, EC – Hormones , paras. 169-172. WT/DS291/R 
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  4.524  The precautionary principle was first recognized in the World Charter for Nature, adopted by 
the UN General Assembly in 1982.  The 1992 Rio Declar ation codified an application of this principle 
in its Principle 15.  Since then, the United Nati ons Framework Convention on Climate Change and the 
Convention of Biological Diversity both refer to the precautionary principle .  More recently, and in 
the specific field of GMOs, the Biosafety Protocol has confirmed the key function of the precautionary principle in the decision to restrict or prohibit imports of GMOs in the face of scientific uncertainty. 
8. Conclusion 
4.525  In conclusion, the Panel has b een called upon to decide what the reasonable attitude of a 
prudent government should be faced with scientific  complexity and uncertainty of a kind and on a 
scale unique and unprecedented in the history of trade in agricultural products.  It is an important and 
delicate task and it will have consequences far beyo nd this case.  GMOs are not an issue which is 
confined to the WTO and the close attention of stat es, other international organisations, civil society, 
industry and others, rests on the work of this Panel. 
4.526  The European Communities is confident that, ap art from the absence of any moratorium, the 
Panel will also find that in applying a regulatory process for effective and forward-looking governance, based on a precautionary approach, the European Communities ha s acted in accordance 
with its obligations under the WTO agreements. 
M. S
ECOND WRITTEN SUBMISSION OF THE UNITED STATES  
1. Introduction 
4.527  The United States in its first written submissi on showed that the European Communities' 
moratorium on biotech approvals (both across-the- board, and with respect to individual pending 
product applications), as well as the member State product-specific bans, are inconsistent with the 
European Communities' fundamental obligations  under the WTO Agreement.  The European 
Communities' response to these clear showings of breaches of its WTO obligations have been 
remarkable: the European Communities has failed to address the central issues.  With regard to the 
moratoria, the European Communities' only defence is  that no such measures ever existed.  In taking 
this position, the European Communities asks the Pane l to ignore the statements, and indeed actions, 
of the EC political-level decision-makers.  The European Communities make s this argument even 
though it has informed the Panel that there indeed  is a key political component in the European 
Communities' approval system.  By asking the Panel to find that the moratoria never existed, the 
European Communities is requesting that the Panel a dopt – solely for the purpose of this dispute and 
based only on the assertions of the EC representative in this dispute – a factual finding that is directly 
contrary to reality as understood throughout the European Communities and the worldwide 
agricultural trade community.  In so requesting,  the European Communities would seek to undermine 
the credibility of the WTO dispute settlement system. 
4.528  Instead of acknowledging the reality of the mora torium and then attempting to justify it under 
the legal standards set out in the SPS Agreement , the European Communities has submitted a 
substantial volume of communications  between member States and app licants for biotech approvals.  
None of this information, however , is inconsistent with the fundam ental reality that the European 
Communities had adopted moratoria on biotech approva ls.  To the contrary, staff-level information 
exchanges regarding product applications are entir ely consistent with a moratorium adopted on a 
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  information that the European Communities has submitted confirms that certain member States 
simply were not going to allow final approvals, regardless of the underlying science.   
4.529  With regard to the member States measures,  the European Communities has asserted that 
there "may" be scientific bases for the product bans, but to date the European Communities has failed 
to identify any of them.  This is understandabl e, since the European Co mmunities' own scientific 
committees have reviewed the products and have found that they meet the requirements of the 
European Communities' biotech approval system. 
2. The European Communities' statement of facts is misleading 
(a) The European Communities' statement on the purported risks of biotech products is 
misleading 
4.530  Even though the European Communities' factua l presentation on biotechnology is not tied to 
the legal issues in this disputes, the United States w ould like to note that the European Communities' 
statements regarding the purported risks of biotechnology are fundamentally misleading.  Contrary to 
the European Communities' assertion,  there has, in fact, been c onsensus over the types of risks 
potentially posed by agricultural biotechnology products since the late 1980's.  The consensus among international experts is that, qualitatively, the types of risks potentially posed by products of modern 
biotechnology are essentially the same as those posed by similar products produced through other, 
more traditional technologies. 
4.531  In other words, the types of risks that regulators assess for foods produced through 
biotechnology are qualitatively the same as for foods produced through other methodologies—for 
example, the production of toxins, significant ch anges in composition, and the presence of food 
allergens.  Similarly, the types of environmental risks – for example, the production of plant pests, 
and effects on beneficial non-target organisms – are not qualitatively different between biotechnology 
and non-biotechnology agricultural products.   
4.532  In 1986, the OECD Ad Hoc Group on Safety and Regulations in Biotechnology concluded 
that any potential environmental impacts of reco mbinant DNA organisms are "expected to be similar 
to effects that have been observe d with introductions of naturally occurring species or selected species 
used for agricultural applications."  In 1987 th e US National Academy of Sciences (NAS) published a 
white paper that stated that th e risks posed by biotech organisms are the "same in kind" as those 
associated with organisms that have been modified through other techniques.  
4.533  In 1993, the OECD, through work commissioned by the Group of National Experts on Safety 
in Biotechnology, concluded that the risks potentia lly posed by plants produced through modern 
biotechnology should be approached within the c ontext of the potential risks of plants produced 
through traditional plant breeding.  While the OECD  and NAS may have been the earliest scientific 
bodies to come to these conclusions, the same conc lusion has been reached by other international 
scientific organizations and national scientific advi sory bodies.  In 1996, a joint FAO/WHO expert 
consultation on biotechnology and f ood safety concluded that "Food saf ety considerations regarding 
organisms produced by techniques that change the heritable traits of an organism, such as rDNA 
technology, are basically of the same nature as tho se that might arise from other ways of altering the 
genome of an organism, such as conventional breeding."  The Royal Society of the United Kingdom came to essentially the same conclusion that "a s with genetic modification, conventional plant 
breeding technology (which can involve chemical or  radiation-induced mutagenesis or cross-species 
hybridization) might also cause rearrangements of the genome, and therefore might also cause the activation of previously unknown toxi ns, anti-nutrients or allergens." WT/DS291/R 
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  4.534  The scientific advisory bodies of the European Union have also confirmed the conclusion 
that, for both food and environmental risks, plants produced through modern biotechnology do not present new or novel risks.  In 2003, the Scientif ic Steering Committee of the European Commission 
acknowledged that both the Scientific Committee on Plants and the Scientific Committee on Food 
have concluded in their published risk assessment  that for the "GM crops" reviewed no new safety 
issues to humans or the environment have been presented. The Scientific Steering Committee also 
stated that the "published review of data do not indicate the GM crops presen tly in cultivation pose 
any more risks for humans, animals and the envir onment than do their conventional counterparts." 
4.535  The level of scientific uncertainty claimed by  the European Communities to exist around the 
risks posed by biotechnology products is both incons istent with the history of the international 
discussion of this issue and with the actions of i ndividual government regulatory authorities.  In its 
2003 report, the International Council for Science (ICS U) concluded after a synthesis of more than 50 
independent scientific reviews that there is "c onvergence of science" that "Presently available 
genetically modified foods are safe to eat. GM f oods presently on the market have been assessed for 
any risks of increased allergenicity, toxicity, or ot her risks to human health, using internationally 
agreed food safety standards. … This is the consensus view of  several reports by national and 
international agencies." 
4.536  In addition, government regulatory authorities with experience in regulating plants produced 
through modern biotechnology routinely use a case-by-case approach.  For example, the United 
States, Canada, the European Communities, Japan, Australia, and South Africa have completed risk assessments on plants produced thro ugh biotechnology – essentially addressing the same types of risk 
assessment end points on a case-by -case basis.  The foundation for this case-by-case approach to the 
regulation of biotechnology plants is the widely held  scientific consensus that: 1) the risks potentially 
associated with biotech plants are essentially the same as those of plants produced by other techniques 
and 2) the assessment of risk should not focus on  the methodology used in the breeding process but 
rather on the results of that process; i.e., on the characteristics of the product itself.   
4.537  To further illustrate the scientific consensus surrounding the types of risks potentially posed 
by biotech plants, both the Codex Alimentarius and the International Plant Protection Convention 
have adopted guidances that provide recommendations on the type of data that should be considered 
when conducting safety assessments for biotech plants .  Both of these standard setting bodies were 
able to conclude these guidelines because of the alread y existing consensus on the types of risk issues 
that should be addressed in the ri sk assessment for biotech plants.  
4.538  If scientific uncertainty concerning the risks of biotech plants had been as great as claimed by 
the European Communities, it is unlikely that any of these products would have successfully 
completed the regulatory process in any country.   The assertion that the complexities – and 
uncertainties – of assessing the risks of the biotech pl ants currently in the EC system are far greater 
than non-biotech products is not born out by experience.  
(b) Neither the biosafety protocol nor the precau tionary approach serves as a defence to the 
European Communities in this dispute 
4.539  The only way other sources of international law c ould be pertinent to this dispute is if, under 
Article 3.2 of the DSU, those other sources of law would assist the Panel in "clarifying the existing 
provisions of the [covered] agreements in accordance  with customary rules of interpretation of public 
international law."  But the European Communities h as not identified how the Biosafety Protocol or a 
"precautionary principle" would be of relevance to  interpreting any particular provision of the WTO 
Agreement.   WT/DS291/R 
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  4.540  Moreover, in the EC – Hormones  dispute, the Appellate Body examined at length nearly 
identical arguments presented by the European Communities regarding the relationship between a 
purported "precautionary principle" and the SPS Agreement .  The European Communities has not 
presented, and cannot argue, that any different results should apply here.  Thus, even if a 
precautionary principle were considered a relevant ru le of international law under Article 31(3) of the 
Vienna Convention, it would be useful only for in terpreting particular treaty terms, and could not 
override any part of the SPS Agreement .  So, for example, the notion of precaution could not excuse 
the European Communities from complying with th e requirement under Article 5.1 that SPS measures 
be based on risk assessments.  In addition, Article 5.7 of the SPS Agreement  already allows for the 
European Communities to adopt a precautionary approach to regulating biotech products.  
4.541  Just as the Appellate Body found it unnecessar y and imprudent to make a finding on the 
status of the precautionary principle in internationa l law, this Panel also should have no need to 
address this theoretical issue.  Nonetheless, the United States notes that it strongly disagrees that 
"precaution" has become a rule of international la w.  In particular, the "precautionary principle" 
cannot be considered a general principle or norm of international law because it does not have a 
single, agreed formulation.  In fact, quite the opposite is true: the concept of precaution has many 
permutations across a number of different factors.  Thus, the United States considers precaution to be 
an "approach," rather than a "pri nciple" of international law.  
4.542  Moreover, if – as the United States submits – pr ecaution is not a principle of international 
law, then it is a fortiori  not a rule of customary international law.  Customary international law is a 
binding rule that results from:  (1) a general, c onsistent, extensive, virtually uniform practice of 
States;  (2) followed by them from a sense of legal obligation.  Precaution does not fulfil any of these 
requirements.  Precaution cannot be considered a "r ule" because it has no clear content and therefore 
cannot be said to provide any authoritative guide for a State's conduct.  Second, it cannot be said to 
reflect the practice of States, as it cannot even be uniformly defined by those who espouse it.  Third, 
given that precaution cannot even be defined and, th erefore, could not possibly be a legal norm, one 
could not argue that States follow it from a sense of legal obligation. 
4.543  For the purposes of interpreting the WTO Agre ement in accordance with the principles in 
Article 31(3) of the Vienna Convention, the United States also strongly disagrees with any notion that 
the Biosafety Protocol is a rule of internationa l law.  To be relevant under Article 31(3), the 
international rule must be "applicable in the relati ons between the parties."  In this case, however, the 
Biosafety Protocol is not applicable to rela tions between the United States and the European 
Communities, because the United States is not  a party to the Biosafety Protocol.   
4.544  Finally, the United States would not agree that th e Panel would need to look to the  Biosafety 
Protocol in interpreting the WTO Agreement even  in a dispute between WTO Members that were 
both parties to the Protocol.  The Protocol has a clear and unequivocal statement that it does not 
change the rights and obligations under any existi ng international agreement.  In addition, the 
European Communities does not argue that any provisi on of the Protocol is in any way inconsistent 
with the European Communities' full compliance with its WTO obligations. 
(c) The European Communities' description of its  biotech approval regime is inaccurate 
4.545  In describing the "European Communities'  regulatory Framework," the European 
Communities conveniently leaves out a number of mandatory procedural steps, omits several 
deadlines by which specific action is required, a nd implies that the Commission has discretion –  
which the legislation does not grant – not to act on product notifications.  But an accurate presentation 
of the EC system is important, because this serves as the baseline for understanding that the European WT/DS291/R 
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  Communities' delays under the moratorium are in consistent with the European Communities' own 
laws.  The inconsistency of the European Comm unities' moratorium with the underlying biotech 
approval legislation further highlights that the delays resulting from the moratorium are undue. 
3. The SPS Agreement  applies to all measures in this dispute 
4.546  In its first written submission, the European  Communities argues at length, and in the 
hypothetical, that the European Communities might adopt measures with respect to one or more 
biotech products that are not covered within the scope of the SPS Agreement .  But, once again, the 
European Communities' discussion is not linked to any of the legal issues in this dispute.   
4.547  The pertinent question is whether the measures that the European Co mmunities has actually 
adopted, and that are covered in this dispute's te rms of reference, are within the scope of the 
SPS Agreement.   But the European Communities does not ev en appear to contest this fundamental 
point.  First, the European Communities has not di sputed that both its Novel Foods regulation and 
Deliberate Release directive are covered within the scope of the SPS Agreement .  Furthermore, with 
respect to the member State m easures, the European Communiti es acknowledges that each of the 
member State measures was adopted for "some re asons" that fall within the scope of the 
SPS Agreement . 
4.548  The European Communities' agreement that its  measures were adopted for "some reasons" 
covered within the scope of the SPS Agreement  is more than sufficient to  bring those measures within 
the scope of that Agreement.  Annex A to the SPS Agreement  makes clear that "any measure" applied 
to protect against one of the enumerat ed risks falls within the scope the SPS Agreement .  The 
Annex does not state that the measure needs to be  exclusively applied to protect against only the 
enumerated risks.  In fact, in the EC – Hormones  dispute, the EC directive was not solely adopted to 
address alleged affects on human health.  To the contrary, as the Appellate Body explained, the 
European Communities was al so motivated to adopt its Hormones Directive by the perceived need to 
harmonize beef regulations in order to prevent di stortions in the conditions of competition between 
producers in various EC member States.  The ha rmonization of product standards is a goal expressed 
in the TBT Agreement .  Yet, despite the variety of rationales, all parties in the EC – Hormones  dispute 
agreed that the Hormones Directiv e fell within the scope of the SPS Agreement .   
4.549  The detailed European Communities' discussion purpo rting to classify various alleged risks of 
biotech products as within or without the scope of the SPS Agreement  is not tied to the legal issues in 
this dispute and is thus hypothetical.  Nonethel ess, the United States has responded to these arguments 
in an attachment to its second written submission, a nd notes that the European Communities' analysis 
would result in an overly narrow scope of th e  measures intended to be covered by the 
SPS Agreement . 
4.
 General moratorium violates the SPS Agreement  
4.550  The European Communities' discussion of the gene ral moratorium is remarkable in that it is 
concerned solely with whether or not the gene ral moratorium qualifies as a "measure" under the 
SPS Agreement .  Should the Panel find, as the complaini ng parties all submit, that the general 
moratorium is indeed a measure under the SPS Agreement , the European Communities has not 
contested that the general moratorium is inconsis tent with the European Communities' obligations 
under the WTO Agreement.  Indeed, in its answer s to Panel's questions, the European Communities 
concedes that there was no overall risk assessment for biotech products that could serve as a basis for 
the general moratorium.    WT/DS291/R 
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  4.551  The evidence that the general moratorium exists is overwhelming.  In addition to the evidence 
that the United States cited in its first written subm ission and opening statement, official documents of 
the European Parliament also confirm the existence of the moratorium.  For example, a February 2001 
parliamentary Report: "Observes that the existing de facto  moratorium particularly harms small and 
medium sized enterprises which, unlike multinational corporations, are often unable to perform their 
research work in countries outside the EU"; "Wel comes the agreement reached between Council and 
Parliament in the conciliation committee on the am endment of the directive on the release of 
genetically modified organisms and the assurances given by the Commission in that connection with 
regard to labelling and traceability, and considers that  a clear framework now ex ists for the release of 
genetically modified organisms in Europe whic h will ensure maximum consumer protection and 
environmental protection, and that it would therefore not be justified to continue the de facto  
moratorium on the release of GMOs"; and notes that "Under this system approval takes an unacceptably long time. ... [N]o authorizations have  been approved under this directive since October 
1998.  This demonstrates a lack of mutual recognition between member States and a de facto  
moratorium on all development.  It calls into qu estion the political will in Europe to support this 
industry." 
4.552  More recently, a March 2003 resolution introdu ced in the European Parliament acknowledges 
the moratorium: "whereas, in view of the risks wh ich GMOs represent, there are no grounds for lifting 
the de facto  moratorium on GMO authorization, especially  since no labelling and tracing system has 
been introduced and no assessment has been carried  out of the impact which GMOs may have on 
organic/conventional farming."  The same resoluti on then goes on to urge the continuance of the 
moratorium pending the launch of  "a broad public debate."  
4.553  The European Communities presents three argume nts in its first written submission as to why 
this Panel should nonetheless find that there is no general moratorium.  First, the European 
Communities argues that it cannot be "legally affected " by "casual statements of any of its numerous 
representatives."  But the complaining parties are not relying on "casual statements of numerous 
representatives"; the statement cited by complaining parties are statements made by the European 
Communities' highest officials, by its member St ates, and by its official bodies.  Moreover, the 
European Communities itself concedes, as it must, that such statements can be considered as evidence 
of the existence of a measure.   
4.554  Second, the European Communiti es argues that even if the Eu ropean Communities did adopt 
a general moratorium on approvals of biotech products , such a moratorium is legally precluded from 
qualifying as a "measure" under the SPS Agreement . The European Communities' argument, however, 
is based on two panel reports that are inapposite to  this dispute.  The United States does not contend 
that the European Communities' suspension of its approval process constituted a "practice" as 
described in the US – Steel Plate and US – Export Restraints reports cited by the European 
Communities.  Although the European Communitie s' measure was not adopted in a transparent 
manner and officially published as a formal law, d ecree or regulation, the European Communities' 
decision to indefinitely suspend its approval pro cedures falls within the SPS definition of a measure 
and blocks biotech approvals just as effectively as would a written amendment to EC legislation.  
4.555  Third, the European Communities claims that the application histories for certain products 
covered in the US panel request disprove the exis tence of the moratorium.  To the contrary, the 
information submitted by the European Communiti es is entirely consistent with the European 
Communities' imposition of a general moratorium.  Fi rst, the information submitted by the European 
Communities confirms that there were in fact no approvals of biotech prod ucts between October 1998 
and the establishment of the Panel's terms of refe rence in August 2003.  Second, not only do the WT/DS291/R 
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  product histories confirm that no product was s ubmitted for final approval, many of the product 
histories – as described below – illustrate just how the moratorium operated.  
5. Product-specific moratoria violate the SPS Agreement  
4.556  The primary basis for the European Communities'  denial of the product-specific moratoria is 
the vague statement that "what has happened in many of these applications is that, at different stages 
of the procedure, requests for additional informatio n have been put to applicants."  The European 
Communities ignores, however, that product histories exhibiting requests for information are entirely consistent with the existence of a general and product-specific moratoria.  The United States has not 
claimed that each and every application stopped all progress beginning in 1998.  To the contrary, the 
moratorium was a decision by the European Commun ities not to move products to a final decision in 
the approval process.  Certain progress in the process, short of final decision, is not the least bit inconsistent with a morato rium on final approvals.   
4.557  Moreover, the European Communities' product hist ories provide further, compelling evidence 
of the existence of both a general and product-specific moratoria.  First, a number of applications – 
particularly those nearing the final stage of approva l – exhibit lengthy, unwarranted delays, unrelated 
to any requests for additional information.  Second , a number of product histories contain statements 
from member States acknowledging – in writing – that  regardless of any scientific issues regarding 
the particular application at issue, the member State simply was not going to vote for approval unless and until the European Communities had adopted new form s of legislation.  Such statements illustrate 
that, contrary to the European Communities' asser tions, the moratorium applied to each and every 
application, regardless of whether or not partic ular regulators had particular questions about 
individual applications.  
(a) Examples of applications which faced lengthy  delays, without any pending requests for 
information 
4.558  Oil-Seed Rape MS1, RF1 and Oil-Seed Rape, MS1, RF2 :  In these two cases, France never 
allowed the product to be placed on the market, and thus these products in fact were never approved 
for cultivation, import, and marketing in the Europ ean Communities.  In Question 99, the Panel asked 
the European Communities to confirm that France wi thheld its consent.  The European Communities 
responded "Yes."  The European Communities then goes on to argue that, nonetheless, an individual 
"can directly assert his or her right by directly relying on the Community law in question."  This 
excuse is entirely unpersuasive.  The European  Communities does not assert that either of these 
products is in fact on the market in the European Communities; that EC Customs officials – in France 
or elsewhere – would admit either of these oil-seed  products without the final step (the French 
consent) in the approval process; or that any biot ech applicant has ever successfully asserted this 
right.  Nor does the European Communities even attemp t to explain what mechanism – such as a legal 
challenge – might be used to assert this right, or explain how a product can be considered approved if 
additional legal proceedings are required to a llow the product to be placed on the market.  
4.559  BT-Cotton :  In February 1999 the regulatory committee did not approve the application by a 
qualified majority vote.  Under the European Commun ities' own rules, an application that fails to 
achieve a qualified majority of votes in the regulat ory committee must be submitted to the EC Council 
for an additional vote, and such submission must be  made, to quote Article 21 of the EC Directive, 
"without delay."  But, the European Communities' ow n chronology states that the next action is nearly 
three months later, in May 1999.  And the action taken is not, as required under EC legislation, the 
submission of the application to the EC Council.  Instead, the chronology states:  "Launching of Inter- WT/DS291/R 
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  Service Consultation on draft Council Decision."  This  term, and this step, is not provided for under 
the European Communities' regulations.  The chr onology is then blank until July of 2001.   
4.560  Roundup Ready Cotton :  In February 1999, the Roundup Ready cotton application, like Bt 
cotton, did not receive a qualified majority vote in  the regulatory committee.  Like for Bt cotton, the 
next step in the European Communities' chronology  is the "Launching of Inter-Service Consultation 
on draft Council Decision" in May 1999.  There is no further entry in the chronology until January 
2003, which is more than two and one-half years late r.  Again, this is another example of a major 
delay that was not caused, as the European Communitie s' claims, by a pending request to the applicant 
for additional information. 
4.561  Oilseed rape tolerant for glufosinate-ammonium :  According to the European Communities' 
chronology, this product received a favourable opi nion from the scientific committee on plants in 
November 2000.  Under the European Communities' a pproval system, the next step should have been 
to submit the application for approval by the Eur opean Communities' Regulatory Committee.  But the 
European Communities' chronology shows that no action was taken on the application until 
November 2002, a full 2-year delay.  This 2-y ear gap belies the European Communities' assertions 
that under its supposed "interim approach," it was moving ahead on processing applications in advance of the entry-into-force of 2001/18.   
4.562  Maize BT-11 :  In the chronology of BT-11, there is no action on the application for 2 years 
after a favourable opinion of the Scientific Committee on Plants in November 2000.  The next entry, 
an "evaluation of updates by the lead CA" in October 2002, is unexplained and unsupported by any 
exhibit or attachment. 
(b) Product histories in which member States acknow ledge opposition to approval regardless of 
the merits of the individual application 
4.563  The exhibits accompanying the product hist ories provide numerous examples in which 
member States noted in writing that they would oppose approvals until some type of new legislation 
was adopted, even though under EC law any objec tion had to be based on the merits of the 
application.  These statements by member States sta nd in stark contrast to the European Communities' 
argument that it had adopted an "interim approach " under which final approvals  were to be granted 
prior to the adoption of new legislation.  They al so directly contradict the European Communities' 
arguments that the delays with respect to indi vidual products were just ified by fact-specific 
considerations unique to the individual products, su ch as conflicting science, or delays on the part of 
applicants.   
4.564  Novel Food and Feed Regulation.   Some member States have used the implementation of new 
food and feed regulations (which did not become effective until April 2004) as an excuse for halting 
this process.  Pioneer/Dow's Bt corn application
:  The Austrian Federal Ministry of Health and 
Women notes in its letter to the EU's DG XI, da ted 24 October 2003, that any registration of 
Pioneer/Dow's product "should also take into cons ideration the two new EU regulations concerning 
traceability and genetically modified food and feed which will enter into force in April 2004."  
Roundup Ready corn (NK603) :  In a letter from the Austrian Fede ral Ministry for Social Affairs and 
Generations to the EU's DG XI regarding Monsan to's application for Roundup Ready corn (NK603), 
the Ministry cites several scientific concerns, but  states that "Irrespective of the above mentioned 
scientific objections raised, Austria is of the opini on, that products shall not be placed on the market 
before the new regulations concerning genetically  modified food and feed as well as on traceability 
and labelling of GMOs will enter into force."   Syngenta's Bt11 biotech sweet corn :   On 10 August 
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  withholding support for Bt11, choosing to disregar d comprehensive scientific findings and instead 
continue the moratorium on biotech reviews. 
4.565  Traceability and Labeling Legislation.  Member States opposed to re-starting the review 
process for biotech crops also used the proposed new traceability and labelling regulations (which 
also did not become effective until April 2004) as a reason for continuing the moratorium.  Syngenta's 
Bt-11 biotech sweet corn :  several member State competent aut horities statements clearly require that 
the new traceability and labelling regulations be in  place prior to the lifting of the moratorium on 
biotech reviews and approvals.  The German comp etent authority's objections, dated September 26, 
2003, provided that "In accordance with the French po sition, the German CA is of the opinion that no 
consent should be given until both regulations are in force.  In particular, the regulation on traceability 
and labelling of GMOs will provide for additional transparency and the possibility of choice for 
consumers."   Likewise, Denmark, in late Sept ember 2003 stated that its support for Bt-11 was 
contingent on the implementation of the new tracea bility and labelling regulations.  In doing so, it 
reminded the EC authority of the March 2001 decl aration of six member States (the "March 2001 
declaration") reaffirming the moratorium until traceability and labelling rules, as well as a system for environmental liability, are adopted.  Again in Februa ry 2004, the Danish competent authority writes:  
"Furthermore, Denmark finds that approval for plac ing on the market cannot take place before the 
regulation on traceability and labelling is full y into force."  Oilseed rape (GT-73)
:   The Danish, 
Italian, Austrian and Belgian competent authoriti es all cite the need for traceability and labelling 
regulations to be in place before they will suppor t the approval of any biotech crops.  The Austrian 
competent authority wrote: "As a matter of principle, this product should not be placed on the market before the entry into force of the Regulation of the European Parliament and of the Council 
concerning the traceability and labelling of genetica lly modified organisms and the traceability of 
food and feed products produced from geneti cally modified organisms and amending 
Directive 2001/18/EC."  Roundup Ready corn (GA21)
:  Denmark acknowledged that "the assessment 
of the health and nutritional aspects of this app lication gives Denmark no reason to object to the 
approval of the GA21 maize nor to products derive d from the maize."  However, "in spite of the 
favourable assessment ... , Denmark will submit a reasoned objection to the approval of the 
genetically modified GA21 maize, reference being made to the statement submitted by this country 
and four other member states at the Environm ental Council on 24 and 25 June 1999 [declaring a 
suspension of new GMO authorizations until labe lling and traceability rules are adopted]."  Bt-11 
sweet corn :  Denmark states that "[w]ith regard to the issue of food safety as such, Denmark sees no 
problem in allowing the Bt11 maize for food purposes ... Apart from this however, Denmark will refer to the Declaration concerning the suspension of new GMO authorizations made by five member States (France, Greece, Italy, Luxembourg, and De nmark) at the Environmental Council of 24 and 25 
June 1999.  With reference to this Declarati on, Denmark therefore wishes to submit a reasoned 
objection concerning the Bt11 maize." 
4.566  Co-Existence and Environmental Liability Legislation.   Several member States have used the 
lack of coexistence and environmental liability laws  as a reason to continue the moratorium.  Such 
rules have no bearing on decisions or assessment s regarding the environment or human or animal 
health or safety, and a desire for such rules cannot justify delay.  Otherwise, a Member could always 
say it would like a better regulatory regime in other aspects and delay approvals indefinitely, 
rendering the SPS "undue delay" discipline meaningless.  Glufosinate tolerant and Bt resistant (Bt-11) 
corn:  The Austrian competent authority states: "As this product is in particular destined for 
cultivation in all countries of the European Uni on, Austria – apart from the need for further 
information – raises an objection against the pu tting of this product on the market, as long as all 
conditions for coexistence with GM O-free cultivation methods are not cleared in a sound legal way."  
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  into force."  Denmark once again cites the March 2001 declaration of six member States reaffirming 
the moratorium until traceability and labelling rules,  as well as a system for environmental liability, 
are adopted.  Roundup Ready oilseed rape GT73
:  Austria objected to Roundup Ready oilseed rape 
GT73, as a "matter of principle," requiring that "fur ther issues concerning liability and the coexistence 
of genetically modified, conven tional and organic crops remain to be resolved."  Also, on 
24 March 2003, Denmark objected, citing the Marc h 2001 declaration.  Pioneer/Dow AgroSciences 
Bt corn (Cry1F 1507) :  The Austrian CA, as late as 17 October 2003, objected to the placing on the 
market of Pioneer/Dow AgroSciences Bt corn (Cr y1F 1507), citing coexistence.  The specific reasons 
cited by the CA are generally econom ic in nature, rather than issues of environmental safety: "Import, 
processing and cultivation of GM 1507 maize will result in the presence of adventitious and/or 
technically unavoidable GMO traces in non GMO maize.  Although maize has limited capabilities to 
survive, disseminate or outcross, this may lead to  effects on the implementation of co-existence of 
different agricultural systems (with or without GM O).  As long as the conditions for co-existence are 
not clarified on the EU level, Austria holds the opinion that no consent for the placing on the market 
of 1507 maize should be given."  Roundup Ready corn (NK603) :  Austria states that not only should 
biotech product approvals continue to be su spended until feed and traceability and labelling 
legislation becomes effective, but also, that no bi otech products may be placed on the market without 
coexistence rules:  "In addition the issue of co-e xistence of genetically modified, conventional and 
organic farming is at the moment under discussion a nd has to be resolved."  Denmark also objects, 
again citing to the March 2001 declaration. 
(c) The European Communities' produc t histories are incomplete 
4.567  The European Communities relies almost exclus ively on its product histories to support its 
claim that – despite the statements and actions of EC officials – there were in fact no general or product-specific moratoria.  But the European Commun ities' product histories are incomplete in three 
important ways.  First, the product histories do not cover any products that were withdrawn prior to 
establishment of the Panel.  These failed product app lications are direct, compelling evidence of the 
existence of a general moratorium.  In its first  written submission, the United States noted that 
applications under both the environmental release and novel food legislations  had been indefinitely 
delayed by the general moratorium  and consequently withdrawn, a nd gave nine specific examples. 
The European Communities has failed to pr ovide any chronologies for these products. 
4.568  The European Communities' product histories ar e also incomplete in that the European 
Communities has not provided the underlying documentation for each step in the process.  Instead, in selecting what exhibits to provide to the Panel,  the European Communities has picked and chosen 
among the various chronological entries.   
4.569  Finally, the product histories are incomplete in that they do not include every step in the 
product histories.  Although only the applicants  and the European Communities have access to all 
correspondence, the United States has learned that at  least some of the product histories are missing 
significant entries.  For example, the application history for Fodder Beet A5/15 excludes a reference 
to at least one significant document.  In particul ar, at a point in the pr ocess where the applicant 
believed that it had complied with all outstanding information requests, the chronology omits a letter 
from the lead competent authority to the applicant, stating that: "Since we met the new directive 
[2001/18] has been adopted and as you probably alread y know Denmark and five other member states 
have confirmed their opinion on suspending new aut horizations for cultivation and marketing until 
effective provisions concerning complete traceab ility which guarantees reliable labelling has been 
adopted."   WT/DS291/R 
WT/DS292/R WT/DS293/R 
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  6. Member State measures violate the SPS Agreement  
4.570  The nine measures imposed by six member St ates are sanitary or phytosanitary measures 
which are not "based on" "risk assessment[s]" as required by Article 5.1 of the SPS Agreement .  
Although each of the six member States that have imposed bans on approved biotech products offered 
reasons for their measures – though unjustified acco rding to the scientific committees – none of the 
member States put forth a "risk assessment" as defined in Annex A, paragraph 4.  In response to the 
Panel's Question (No. 107) on this issue, the Eur opean Communities claimed that "the member States 
have made their own assessments and further risk assessments may
 be forthcoming" (emphasis 
added).  The United States submits that, in fact, no such risk assessments supporting the member State 
measures have been provided. 
4.571  In particular, the European Communities ha s provided on their second CD-ROM a folder 
titled "Safeguard Measures," in which the Europe an Communities purports to provide EC member 
State justifications for the member  State measures.  A review of th e documents confirms that none of 
the member State bans is based on a risk assessment. 
4.572  In fact, the only risk assessments put forth fo r the banned products are the positive scientific 
assessments rendered by member States to which th e products were submitted, and then by the 
European Communities' own scientific committees.  In  the case of each me mber State ban, these 
favourable assessments were reaffirm ed when the scientific committees considered and rejected the 
information provided by the member States.  Thus, the member State measures do not bear a "rational 
relationship" to the European Communities' positive risk assessments, and are not "based on" a risk 
assessment, in violation of Articles 5.1 and 2.2 of the SPS Agreement .   
4.573  The European Communities' argument in defen ce is that each of the member State measures 
falls within the scope of Article 5.7 of the SPS Agreement .  But the European Communities does not 
specify how Article 5.7 might apply.  Its only argumen t is that under the terms of the EC legislation, 
the member State measures are labeled as "provisional."  The mere label of a measure, however, is 
most certainly not sufficient to bring it within the scope of Article 5.7.   
4.574  Before turning to the specific criteria of Artic le 5.7, the United States would note that the 
European Communities is incorrect in claiming th at the United States was obliged to include an 
explicit Article 5.7 argument in its first wr itten submission.  This argument fundamentally 
misunderstands the structure of the SPS Agreement .  The United States in its first written submission 
most certainly did explain that the member State measures are inconsistent with Article 2.2 of the 
SPS Agreement , and this necessarily means that the United States submits that Article 5.7 does not 
apply.  In other words, Article 5.7 provides not th e basis for a claim of an alleged breach of a WTO 
obligation, but acts as a defence to shield measures that would otherwise violate Articles 2.2 and 5.1.  
As explained by the Appellate Body in Japan – Agricultural Products II , "Article 5.7 operates as a 
qualified exemption from the obligation under Artic le 2.2 not to maintain SPS measures without 
sufficient scientific evidence." 
4.575  In Japan – Agricultural Products II , as well as in Japan – Apples , another dispute in which 
Article 5.7 was considered, the Respondent invoke d the provision to defend the challenged measure 
against alleged violations of Articles 2.2 and 5.1.  The Complainant (the United States in both cases) did not assert Article 5.7 as an independent claim in e ither dispute, nor did the Panels suggest that the 
Complainant should have invoked Article 5.7.  Ind eed, the United States is not aware of any dispute 
in which the Complainant has based a claim on the Respondent's violation of Article 5.7.