EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL AND MARKETING OF BIOTECH PRODUCTS
Document: Reports of the Panel
Date: 29 September 2006
Document codes: WT/DS291/R; WT/DS292/R; WT/DS293/R
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

EUROPEAN COMMUNITIES – MEASURES AFFECTING
THE APPROVAL AND MARKETING
OF BIOTECH PRODUCTS

Reports of the Panel

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 establishment 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 establishment 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.

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.

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 meeting 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 restricting 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.

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 parties' 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 panel 12, 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 panel 13, 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.

C. A
RGENTINA
3.6 Argentina, in its request for establishment of a panel 14, 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 Argentina 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' arguments 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 States 16, Canada 17 and Argentina 18 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 available such summaries to the Panel.
16 WT/DS291/23.
17 WT/DS292/17.
18 WT/DS293/17.

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 applications 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.

(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 distinct 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.

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 challenged 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.

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 obligations 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 preparation 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 guaranteeing 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

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 panel 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 claims 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 participate 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.

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 ensure 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 Requests 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 disputes 43 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.

specific measures at issue and provide[s] a brief summary 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 panel 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.

"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 the 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.

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 granting 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 Communities 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 circumstances 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.

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 meetings 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.

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 III 57 (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.

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 explanation 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.

establishment. In the circumstances, the United States cannot now, in our view,
assert that the European Communities' claims ... 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 – and 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 the 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.

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 identified 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 conjunction 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

by the EC of its own processes for consideration of applications for, and the 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 the 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 specific 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 violated 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.

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 references to the listed paragraphs 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 complaint 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 being violated. Canada has met the requirement to
clearly identify the specific measures. The subsequent 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.

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 panel 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 that 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 out legal arguments in a panel request. The European
Communities' arguments in this regard are clearly 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".

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 need 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 European 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 credibility. 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.

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 compared 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 proceedings. The relevant question at this point
of the analysis is:which action by the European Communities led to the measure at issue? The answer
may be found easily by referring to the second 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 moratorium 69
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 action 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.

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.

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 – Dairy 79
quoted by the European Communities is not relevant in this case, since in Korea – Dairy the terms of
reference included quotations of general 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.

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 Communities 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 substantiated 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 granted 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 enjoying the benefits of these products, without any adverse health
or environmental effects.

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 fairly 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 bans 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 Communities' 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, fertilizers, and water in commercial farming.
4.137 Modern biotechnology can significantly increase agricultural 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

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 for 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 reducing harm to ground and 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 the 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 oilseed rape (canola) and nine percent of corn.

(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 reportedly "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 science 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

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 importation 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.

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 consumer" or be "nutritionally disadvantageous."
4.156 In addition to the purpose that is set out so clearly 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 Commission "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 levels of pesticide residue in pesticide-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 feedstuffs." 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 prevent 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).

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 suspension 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 Member could avoid its SPS obligations by adopting a
nontransparent, unwritten SPS measure that has a negative 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 required 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.

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 "inappropriate, 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 considered "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,

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 approval 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, application 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 products (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 ... ." The 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 general moratorium bears a relationship, rational or otherwise, to a
risk assessment when there is no evidence that any risk assessment ever existed.

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 general 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 products produced with biotech processing aids
as such. In contrast to new biotech processing aids, 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 associated 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

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 more 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

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 required 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);

(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 (referred 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

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 rejection, 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
restrict or prohibit the use or sale of an approved biotech product in its territory if that member State

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.

(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 protection 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 has 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

("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 other two identified classes of products.
4.214 The differences in the European Communities' levels 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 levels 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.

(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 and 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 completing 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 general 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 Article 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 product-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

in European Communities' approval legislation. The failure of the European Communities to consider
or approve, without undue delay, the specific 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 physical 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 perceived only at the molecular level.

• The specific 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

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 specific products have been accorded treatment less favourable than "like"
products of national origin in violation of Article III:4 of the GATT 1994.
(c) The product-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 measures (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.

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.

(iv) The EC member State national measures violate Article 5.5
4.238 The European Communities' level of protection with 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 commercialization 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 non-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 other two identified classes of products.
4.241 The differences in the European Communities' levels 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.

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, domestically-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

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 relating 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 preferences 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 treatment 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 unfettered 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 inconsistent 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 European Communities has caused undue delay by failing to
consider and/or not completing the processing of applications submitted w ith regard to various

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, the need to have additional 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 instruments 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 health or the environment, it is covered by the first
paragraph of Annex A.

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 inconsistent 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 inconsistent 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 Communities 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 "relevant 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 accordingly 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.

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 than 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 inconsistent 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 cumulative 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 and 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 new biotech products and new "non-biotech"
products, thereby satisfying the first element of the 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.

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 which are produced outside the 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-vis producers within the European Communities.
(vi) The de facto moratorium is inconsistent 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 inconsistent 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 inconsistent 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

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 [hereafter "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 European Communities did not undertake any type of
risk assessment provided by paragraph 4 of Annex A as the basis for the suspension. 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 suspension (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 that 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 levels 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

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 products 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 particular paragraph 1(a), 1(b), 1(c) and 1(e).

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

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 determined 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. Therefore, 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" violates 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 procedures" pursuant to Annex 1, paragraph 3.

(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 technical 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' legislation 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 with 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' legislation 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 has 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

those posed by their "non-biotech" counterparts. Nonetheless, these products have not been approved,
which is clearly more restrictive than necessary 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 European 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 European 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 first 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.

(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 inferred from the relevant EC legislation. 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 and 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 justified 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 o m t h a t u s e d b y t h e
European Communities for the same products . However, as these products have the same level of
risk, the member States are applying different levels 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

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 originate 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 Article 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.

(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 established 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 specific biotech agricultural products. 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 are 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 arguments in the relevant part of this submission.
(iii) The application of the European Communities' legislation 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 member 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.
No relevant international standard exists. The ba ns are having a significant effect on other Members'

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 received 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 avoid 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 Communities 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 framework 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

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 complaining 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 which 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 panel 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;

• 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.

(b) International and comparative 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 information 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 treated 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
can be found, a decision has to be taken at Commun ity level. The Commission consults a scientific

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 Directive 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 stalled 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 treating 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 applicant 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, many 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
in the past were also related to requirements which were not yet foreseen in the legislation existing at

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, changing 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 legislation) 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 European 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 clearly 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

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

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 which 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 been "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 and 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 complaining 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 products are treated less favourably than domestic like
products. The European Communities has not taken more time to authorize the importation of the

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 whole. 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 constitute 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

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 States 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 products 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.

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 habits 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 inconsistent with any of the provisions invoked by the complaining parties,

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 paragraphs (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 Communities 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 process 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. Most 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

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 "undue 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 obligations under Article 8 and Annex 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 levels 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 acknowledgment that those procedures had been suspended.
4.396 Commission documents also confirm the existen ce of the moratorium. Most recently, in an
official Background document to the Agriculture and Fisheries Council of Ministers held on 26 April

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 Panel's terms of reference 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 marketing 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

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 Consultation" 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 entirely 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 European Communities itself has 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 flora 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

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 would 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

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 "relevant 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.

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 moratorium 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;

• 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 necessary 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 unrelated 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.

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 legislation 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 also 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

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 opinions 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 measure 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 rights 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 without sufficient scientific evidence. The Member must demonstrate
that the measure in question is not adequately su pported by scientific evid ence. Nowhere does the

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 circumstances, 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 provisions 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 arguments 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 satisfy 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 product 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".

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 agrees 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 assessments. 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 "reasonably 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 protection – 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.

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 that 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.

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", which, 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 refer 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 the evidence submitted, to consider the existence
of the de facto moratorium as having been demonstrated above.

(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 phytosanitary 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 Communities 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.

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 requisite 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 scientific 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, the other arguments related
to provisions violated by the European Communities 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.

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 attempt by the European Communities to mount a defence
based on an exception under Article XX of the GATT 1994.

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

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 interest to Argentina started in 1998.
(c) Conclusions regarding special and differential 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 approaches, 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

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 inherently 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 against 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.

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 developing 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
immediately. The proposal for the decision has made its way through the decision-making procedures

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.

(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 Article 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.

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 Declaration codified an application of this principle
in its Principle 15. Since then, the United Nations 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
political level, under which no pr oduct was allowed to reach final approval. Moreover, the very

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 observed 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 toxins, anti-nutrients or allergens."

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 environment 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 through 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 risk 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.

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 the 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 "principle" 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

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 Directive fell within the scope of the SPS Agreement.
4.549 The detailed European Communities' discussion purporting 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. Nonetheless, 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.

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 submission 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 which 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 products between October 1998
and the establishment of the Panel's terms of refe rence in August 2003. Second, not only do the

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 moratorium 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 attempt 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 allow 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 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 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-

Service Consultation on draft Council Decision." This term, and this step, is not provided for under
the European Communities' regulations. The chronology 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 Communities' 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 stand 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
2000, the French authorities cited the yet to be im plemented food and feed regulations as a reason for

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."
Belgium makes the same objection for the same product: "Belgium is of the opinion that the placing
on the market of this product should not be granted before a coexistence regulation is not yet entered

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 "further 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' product 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 provide 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 already 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."

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.