WT/DS291/R
WT/DS292/R
WT/DS293/R
Page 107
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 107
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 moratoria violate the SPSAgreement 37
(c) EC member State 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 member State national measures 46
(a) The EC member State national measures violate the SPSAgreement 46
(i) The EC member State national measures violate Article5.1 46
(ii) The EC member State national measures violate Article5.6 47
(iii) The EC member State national measures violate Article2.2 47
(iv) The EC member State national measures violate Article5.5 48
(v) The EC member State national measures violate Article2.3 49
(b) The EC member State national measures violate GATT 1994 49
(i) Four EC member State 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 member State bans are inconsistent with the SPSAgreement 61
(i) The EC member State bans as measures under the SPSAgreement 61
(ii) The member State bans are inconsistent with Article5.1 61
(iii) The member State bans are inconsistent with Article2.2 61
(iv) The member State bans are inconsistent with Article5.5 61
(v) The member State bans are inconsistent with Article2.3 62
(vi) The member State bans are inconsistent with Article5.6 62
(b) The member State 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. Member State 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. EC member State 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. Member State 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