WT/DS291/R
WT/DS292/R
WT/DS293/R
Page 1
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
Page 1
TABLE OF CONTENTS
Page
TABLE OF CASES CITED IN THIS REPORT...... xli
LIST OF ABBREVIATIONS...... xlv
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 measure at issue"...... 6
(a)The "measures" as described in the Requests...... 6
(b)Speaking of two distinct measures, suspension and failure to act, without describing them, the requests fail to identify the specific measure at issue 7
3.The Panel requests do not provide a brief summary of the legal basis of the complaint sufficient to present 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.Article6.2 issues must be decided as early as possible in the proceedings...... 9
(a)The Panel has to be able to establish 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 Article6.2.....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
1.Introduction...... 11
2.The requirements of Article6.2 of the DSU...... 12
3.The European Communities' assertion that the US panel request does not identify the "specific measures at issue" is incorrect 13
4.Contrary to the European Communities' allegations, the US panel request provides a brief summary of the legal basis 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 17
6.The European Communities failed to raise its Article6.2 concerns at the earliest possible opportunity 17
C.Preliminary Written Submission of Canada...... 18
1.Introduction...... 18
2.Requirements of Article6.2 of the DSU...... 18
3.Canada's Panel request identifies the "specific measure at issue" as required by Article6.2 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 Article6.2 20
(a)In view of the circumstances surrounding this case, Canada's listing of the relevant provisions complies with the requirements of Article6.2 20
(b)Canada's panel request establishes an adequate link between the provisions listed and the measures at issue, consistent with Article6.2 21
(c)Article6.2 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 22
D.Preliminary Written Submission of Argentina...... 23
1.Introduction...... 23
2.Object and purpose of Article6.2...... 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
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 SPSAgreement...... 32
(b)Product-specific moratoriaviolate the SPSAgreement...... 37
(c)ECmemberState marketing or import bans violate the SPSAgreement...... 37
(d)Greek import ban violates ArticleXI...... 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 SPSAgreement...... 41
(i)The moratorium violates Article5.1...... 41
(ii)The moratorium violates Article5.6...... 42
(iii)The moratorium violates Article2.2...... 42
(iv)The moratorium violates Article5.5...... 42
(v)The moratorium violates Article2.3...... 43
(vi)The moratorium violates Article8 and paragraph 1(a) of AnnexC...... 44
(vii)The European Communities has violated Article7 and Paragraph 1 of AnnexB by failing to "publish promptly" the moratorium 44
5.The product-specific marketing bans...... 44
(a)The product-specific marketing bans violate the SPSAgreement...... 44
(b)The product-specific marketing bans violate ArticleIII:4 of the GATT 1994...... 44
(c)The product-specific marketing bans violate the TBTAgreement...... 46
6.The EC memberState national measures...... 46
(a)The EC member State national measures violate the SPSAgreement...... 46
(i)The EC memberState national measures violate Article5.1...... 46
(ii)The EC memberState national measures violate Article5.6...... 47
(iii)The EC memberState national measures violate Article2.2...... 47
(iv)The EC memberState national measures violate Article5.5...... 48
(v)The EC memberState national measures violate Article2.3...... 49
(b)The EC member State national measures violate GATT 1994...... 49
(i)Four EC memberState national measures violate ArticleIII:4...... 49
(ii)Greece's import ban on Topas 19/2 violates ArticleXI:1...... 50
(c)The TBTAgreement applies to the EC member State national measures...... 50
G.First Written Submission of Argentina...... 50
1.Introduction...... 50
2.Inconsistency with the SPSAgreement...... 51
(a)Inconsistency of the defacto moratorium with the SPSAgreement...... 51
(i)The defacto moratorium as a measure under the SPSAgreement...... 51
(ii)The defacto moratorium is inconsistent with Article5.1...... 52
(iii)The defacto moratorium is inconsistent with Article2.2...... 52
(iv)The defacto moratorium cannot be justified under the exception provided for in Article5.7 52
(v)The defacto moratorium is inconsistent with Article5.5...... 53
(vi)The defacto moratorium is inconsistent with Article2.3...... 54
(vii)The defacto moratorium is inconsistent with Article7 and AnnexB:1.54
(viii)The defacto moratorium is inconsistent with Article 10.1...... 54
(b)Inconsistency of the "suspension of processing and failure to consider individual applications for approval of specific biotech agricultural products of particular interest to Argentina" with the SPSAgreement 54
(i)Suspension of the approval processes for biotech agricultural products of particular interestto Argentina 54
(ii)The suspension is inconsistent with Article5.1...... 55
(iii)The suspension is inconsistent with Article2.2...... 55
(iv)The suspension is inconsistent with Article5.5...... 55
(v)The suspension is inconsistent with Article5.6...... 56
(c)Inconsistency with the SPSAgreement of the "undue delay" in the processing of individual applications for approval of biotech agricultural products of particular interest to Argentina 56
(i)Analysis in light of the provisions of Article8 and paragraph 1(a), 1(b), 1(c) and 1(e) of AnnexC 56
3.Inconsistency with GATT 1994...... 57
(a)Inconsistency with ArticleIII:4...... 57
(i)"Like products" within the framework of ArticleIII:4...... 57
(ii)The suspension is a "requirement" affecting "the sale, offering for sale, purchase, transport, distribution and use of products on the domestic market" 58
(iii)"Less favourable treatment" is accorded...... 58
4.Inconsistency with the TBTAgreement...... 58
(a)Alternative application of the TBTAgreement...... 58
(b)Inconsistency with the TBTAgreement of the application of the European Communities' legislation in relation to the approval of biotech agricultural products of particular interest to Argentina 59
(i)The European Communities' legislation constitutes "technical regulations" pursuant to paragraph 1 of AnnexI 59
(ii)The procedures under the European Communities' legislation constitute conformity assessment procedures 59
(iii)The application of the European Communities' legislation is inconsistent with Article2.1 59
(iv)The application of the European Communities' legislation is inconsistent with Article2.2 59
(v)The application of the European Communities' legislation is inconsistent with Articles5.1.1, 5.1.2, 5.2.1, 5.2.2. 60
(vi)Inconsistency of the application of the European Communities' legislation with Article12 60
5.Bans by various EC member States...... 60
(a)The memberState bans are inconsistent with the SPSAgreement...... 61
(i)The EC member State bans as measures under the SPSAgreement...... 61
(ii)The memberState bans are inconsistent with Article5.1...... 61
(iii)The memberState bans are inconsistent with Article2.2...... 61
(iv)The memberState bans are inconsistent with Article5.5...... 61
(v)The memberState bans are inconsistent with Article2.3...... 62
(vi)The memberState bans are inconsistent with Article5.6...... 62
(b)The memberState bans are inconsistent with the GATT 1994...... 62
(i)Inconsistency with ArticleIII:4...... 62
(c)Inconsistency of the EC member State bans with the TBTAgreement...... 63
(i)The European Communities' legislation for approval of biotech agricultural products constitutes "technical regulations" pursuant to paragraph 1 of Annex1 63
(ii)The bans applied by some EC member States to specific biotech agricultural products of particular interest to Argentina are inconsistent with Article2.1 63
(iii)The application of the European Communities' legislation is inconsistent with Article2.2 63
(iv)The bans imposed byEC member States on specific biotech agricultural products of particular interest to Argentina are inconsistent with Article2.9 of the TBTAgreement 63
H.First Written Submission of the European Communities...... 64
1.Introduction...... 64
2.Factual part...... 66
(a)Scientific background...... 66
(b)International and comparative 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)SPSAgreement...... 70
(iii)GATT 1994 – ArticleIII: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)SPSAgreement...... 72
(ii)The GATT 1994...... 73
(iii)The TBTAgreement...... 74
(e)The special and differential treatment claims...... 74
(f)ArticleXX of the GATT 1994...... 74
4.Conclusion...... 75
I.First Oral Statement of the United States...... 75
1.General comments on European Communities' first written submission...... 75
2.General moratorium violates the SPSAgreement...... 76
3.Product-specific moratoria violate the SPSAgreement...... 79
4.MemberState measures violate the SPSAgreement...... 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
(i)The moratorium is in effect...... 81
(ii)The European Communities denies the ample 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 SPSAgreement...... 83
3.The product-specific marketing bans...... 84
4.ECmemberState national measures...... 84
(a)Article5.7...... 84
(b)Article5.1...... 86
(c)Article5.6...... 86
(d)Article5.5...... 86
K.First Oral Statement of Argentina...... 87
1.Introduction...... 87
2.The defacto moratorium is not based on scientific evidence and therefore infringes the SPSAgreement 87
(a)The measure at issue in these proceedings...... 87
(b)Application of SPSAgreement to the defacto moratorium...... 89
(c)Conclusions with respect to the defacto 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 scientific evidence and therefore violate the SPSAgreement 91
6.ArticleXX of the GATT 1994...... 91
7.Special and differential treatment...... 92
(a)In the framework of the SPSAgreement...... 92
(b)In the framework of the TBTAgreement...... 92
(c)Conclusions regarding special and differential 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
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 SPSAgreement alone cannot dispose of all the issues linked to GMOs...... 97
(d)The issue of delay...... 97
(e)Article5.7 SPSAgreement...... 97
(f)The precautionary principle is a general principle of international law...... 97
8.Conclusion...... 98
M.Second Written Submission of the United States...... 98
1.Introduction...... 98
2.The European Communities' statement of facts is misleading...... 99
(a)The European Communities' statement on the purported risks of biotech products is misleading 99
(b)Neither the biosafety protocol nor the precautionary 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 SPSAgreement applies to all measures in this dispute...... 102
4.General moratorium violates the SPSAgreement...... 102
5.Product-specific moratoria violate the SPSAgreement...... 104
(a)Examples of applications which faced lengthy delays, without any pending requests for information 104
(b)Product histories in which member States acknowledge opposition to approval regardless of the merits of the individual application 105
(c)The European Communities' product histories are incomplete...... 107
6.MemberState measures violate the SPSAgreement...... 108
N.Second Written Submission of Canada...... 109
1.Introduction...... 109
2.The moratorium...... 110
(a)The European Communities' assertion that the moratorium does not exist is without merit.110
(b)Rationalizations for the moratorium...... 111
(c)The European Communities mischaracterizes risks 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
(b)Oilseed Rape Ms8xRf3...... 115
(c)Oilseed Rape GT73...... 116
4.Mootness is not relevant...... 116
5.The European Communities' appropriate level of protection...... 117
6.ECmemberState national measures ("safeguard measures")...... 117
(a)Article5.7 of the SPSAgreement does not apply...... 117
(b)Even if Article5.7 were to apply to the EC member State national measures, it would not exclude the application of Articles5.5 and/or 5.6 118
(c)The EC member State national measures are not based on a risk assessment, as required by Article5.1 119
(d)The EC member State national measures violate the TBTAgreement...... 119
(i)The EC memberState national measures are "technical regulations"...... 120
(ii)The measures violate Article2.1...... 120
(iii)The measures violate Article2.2...... 120
(iv)The measures violate Article2.9...... 121
O.Second Written Submission of Argentina...... 121
1.Arguments...... 121
(a)The defacto moratorium...... 121
(i)Introduction – The existence of a defacto moratorium...... 121
(ii)The defacto moratorium measure...... 122
(iii)Not simply a delay – Disregard of scientific evidence...... 123
(iv)The European Communities implements and maintains a defacto moratorium....123
a.- The "Inter-Service Consultation" phase...... 124
b.- The "Common Position" and the declaration by various member States...... 124
c.- Regarding the "Interim approach"...... 125
d.- Further applications receive positive scientific opinions, before the entry into force of Directive2001/18 125
e.- Claims concerning the review of Directive90/220...... 126
f.- Entry into force of Directive2001/18...... 126
g.- Regarding the traceability and labelling legislation...... 127
h.- Regarding the European Communities' arguments based on the Cartagena Protocol and the so-called "precautionary principle" 127
(v)The defacto moratorium is inconsistent with Article10.1 of the SPSAgreement 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
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)Article5.7 as a defence for measures that would otherwise infringe Articles2.2 and 5.1 134
(ii)Article5.7, Article5.5 and Article5.6...... 135
(iii)Article5.7...... 135
(iv)No invocation regarding the defacto moratorium 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 SPSAgreement...... 136
(ii)Risk assessment and the role of scientific opinions...... 137
(c)The SPSAgreement...... 137
(i)The scope of the SPSAgreement...... 137
(ii)Mixed acts...... 138
(iii)Article2 and Article5.7 of the SPSAgreement...... 139
(iv)Article5.7 and the rest of Article5 of the SPSAgreement...... 139
(v)Article5.7 of the SPSAgreement...... 140
(vi)Article2.3 of the SPSAgreement...... 140
(d)The TBTAgreement...... 140
(i)The meaning of the term "technical regulation"...... 141
(ii)Article2.1 of the TBTAgreement – the issue of likeness...... 141
(iii)Article2.2 of the TBTAgreement...... 141
(iv)Article5 of the TBTAgreement – 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-specific delays...... 142
(i)Factual issues...... 143
The individual product-specific applications/notifications...... 143
The time element...... 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 SPSAgreement...... 145
The TBTAgreement...... 146
GATT 1994 – ArticlesIII: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 European Communities fails to raise any meritorious arguments 148
(a)The European Communities' concept of "mootness" 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 Communities 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 explain 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)...... 152
(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: Roundup Ready corn (NK603)...... 155
(i)EC Exhibit 62: Oilseed rape (FALCON GS40/90)...... 155
(j)EC Exhibit 92: Bt-11 Sweet Corn...... 156
4.ManymemberState requests for information were not based on legitimate scientific concerns 156
(a)MemberState objections do not illustrate scientific disagreement or uncertainty...... 156
(b)Various memberState 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' mischaracterization of Canada's arguments...... 160
(c)Risk assessments and Community-level Scientific Committees...... 160
(d)Interpretive issues relating to the SPSAgreement...... 161
(i)The definition of sanitary and phytosanitary measures...... 161
(ii)Article2 and Article5.7 of the SPSAgreement...... 162
(iii)Article5.7 and the rest of Article5...... 163
(iv)Article5.1...... 163
(v)Article5.5...... 163
(vi)Article5.6...... 164
(vii)Article5.7...... 164
(viii)Article2.3...... 164
(ix)AnnexC(1)(a)...... 164
(e)The TBTAgreement...... 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
(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 defacto moratorium...... 172
(i)The existence of a defacto moratorium...... 172
The "Inter-Service Consultation" phase...... 172
The "Common Position" and the declaration by various member States...... 173
Regarding the "Interim approach"...... 173
Further applications receive positive scientific opinions before the entry into force of Directive2001/18 173
(ii)Conclusion...... 174